RESTORE ME: a RCT of oxaloacetate for improving fatigue in patients with myalgic encephalomyelitis/chronic fatigue syndrome.

Background: The energy metabolite oxaloacetate is significantly lower in the blood plasma of ME/CFS subjects. A previous open-label trial with oxaloacetate supplementation demonstrated a significant reduction in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)-related fatigue.

Methods: In this follow-up trial, 82 ME/CFS subjects were enrolled in a 3-month randomized, double-blinded, controlled study, receiving either 2,000 mg of oxaloacetate or control per day.

Exploring How Values of Colorectal Cancer Patients and their Caregivers Influence Treatment Decision-Making.

Background: As we adopt value models to inform drug reimbursement, coverage, clinical trials, and treatment choices, aligning these models to reflect patient values and preferences becomes increasingly relevant. In this study, we focus on colorectal cancer (CRC), which is highly prevalent and a leading cause of death in Canada, and new drug treatment options are costly.

Objective: The aim of this study was to understand how the values and experiences of people with CRC and their caregivers inform their perspectives about new and emerging colorectal cancer drug treatments.

One Pump for Two Hearts: Using an Impella 5.5 Micro-Axial Pump in Peripartum Cardiogenic Shock.

Cardiogenic shock (CS) occurs infrequently in pregnancy and has a high mortality rate. Medical treatment options are few, with limited evidence of efficacy. Temporary mechanical circulatory supports (tMCS) may play a key role in addressing this therapeutic lacuna.

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.

Background: Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy.

Methods: Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT.

Trial of Selective Early Treatment of Patent Ductus Arteriosus with Ibuprofen.

Background: The cyclooxygenase inhibitor ibuprofen may be used to treat patent ductus arteriosus (PDA) in preterm infants. Whether selective early treatment of large PDAs with ibuprofen would improve short-term outcomes is not known.

Methods: We conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large PDA (diameter of ≥1.

Access to cancer clinical trials for racialised older adults: an equity-focused rapid scoping review protocol.

Background: The intersection of race and older age compounds existing health disparities experienced by historically marginalised communities. Therefore, racialised older adults with cancer are more disadvantaged in their access to cancer clinical trials compared with age-matched counterparts. To determine what has already been published in this area, the rapid scoping review question are: what are the barriers, facilitators and potential solutions for enhancing access to cancer clinical trials among racialised older adults?

Methods: We will use a rapid scoping review methodology in which we follow the six-step framework of Arksey and O'Malley, including a systematic search of the literature with abstract and full-text screening to be conducted by two independent reviewers, data abstraction by one reviewer and verification by a second reviewer using an Excel data abstraction sheet.

Techniques to increase lumbar puncture success in newborn babies: the NeoCLEAR RCT.

Background: Lumbar puncture is an essential tool for diagnosing meningitis. Neonatal lumbar puncture, although frequently performed, has low success rates (50-60%). Standard technique includes lying infants on their side and removing the stylet 'late', that is, after the needle is thought to have entered the cerebrospinal fluid.

Frenotomy with breastfeeding support versus breastfeeding support alone for infants with tongue-tie and breastfeeding difficulties: the FROSTTIE RCT.

Background: Tongue-tie can be diagnosed in 3-11% of babies, with some studies reporting almost universal breastfeeding difficulties, and others reporting very few feeding difficulties that relate to the tongue-tie itself, instead noting that incorrect positioning and attachment are the primary reasons behind the observed breastfeeding difficulties and not the tongue-tie itself. The only existing trials of frenotomy are small and underpowered and/or include only very short-term or subjective outcomes.

Objective: To investigate whether frenotomy is clinically and cost-effective to promote continuation of breastfeeding at 3 months in infants with breastfeeding difficulties diagnosed with tongue-tie.

Construction industry workers' compensation injury claims due to slips, trips, and falls - Ohio, 2010-2017.

Problem: Compared to other industries, construction workers have higher risks for serious fall injuries. This study describes the burden and circumstances surrounding injuries related to compensable slip, trip, and fall (STF) claims from private construction industries covered by the Ohio Bureau of Workers' Compensation.

Methods: STF injury claims in the Ohio construction industry from 2010-2017 were manually reviewed.

Biodistribution of lentiviral transduced adipose-derived stem cells for "ex-vivo" regional gene therapy for bone repair.

Ex-vivo gene therapy has been shown to be an effective method for treating bone defects in pre-clinical models. As gene therapy is explored as a potential treatment option in humans, an assessment of the safety profile becomes an important next step. The purpose of this study was to evaluate the biodistribution of viral particles at the defect site and various internal organs in a rat femoral defect model after implantation of human ASCs transduced with lentivirus (LV) with two-step transcriptional activation (TSTA) of bone morphogenetic protein-2 (LV-TSTA-BMP-2).

Mitigating inequity: ethically prioritizing patients for CAR T-cell therapy.

Manufacturing capacity and institutional infrastructure to deliver chimeric antigen receptor T-cell therapies (CAR-T) are pressured to keep pace with the growing number of approved products and expanding eligible patient population for this potentially life-saving therapy. Consequently, many cell therapy programs must make difficult decisions about which patient should get the next available treatment slot. This situation requires an ethical framework to ensure fair and equitable decision-making.

Survival of bovine digital dermatitis treponemes in conditions relevant to the host and farm environment.

Objectives: Bovine digital dermatitis (BDD), a painful infectious foot disease in dairy cattle, endemic in many countries worldwide, causes substantial economic and welfare impacts. Treponema spp. are considered key to BDD pathogenesis.

Cognitive impairment in post-acute sequelae of COVID-19 and short duration myalgic encephalomyelitis patients is mediated by orthostatic hemodynamic changes.

Introduction: Cognitive impairment is experienced by people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-acute sequelae of COVID-19 (PASC). Patients report difficulty remembering, concentrating, and making decisions. Our objective was to determine whether orthostatic hemodynamic changes were causally linked to cognitive impairment in these diseases.

Complication Rates and Utilization Trends of 3-Level Posterior Column Osteotomy Compared to Single-Level Pedicle Subtraction Osteotomy.

Objective: The objective of this study is to assess differences in complication profiles between 3-level posterior column osteotomy (PCO) and single-level pedicle subtraction osteotomy (PSO) as both are reported to provide similar degrees of sagittal correction.

Methods: The PearlDiver database was queried retrospectively using International Classification of Disease, 9th and 10th edition and Current Procedural Terminology codes to identify patients who underwent PCO or PSO for degenerative spine disease. Patients under age 18 or with history of spinal malignancy, infection, or trauma were excluded.

Neuroma Treatment With the Acellular Nerve Allograft Reconstruction Technique.

Treatment of a painful neuroma is a challenging problem for both the patient and the providers. Current surgical treatment options typically include excision of the neuroma and stump relation. However, with both treatment options, patients have high rates of persistent pain and rates of neuroma recurrence.

Agroecosystem edge effects on vegetation, soil properties, and the soil microbial community in the Canadian prairie.

Edge effects resulting from adjacent land uses are poorly understood in agroecosystems yet understanding above and belowground edge effects is crucial for maintaining ecosystem function. The aim of our study was to examine impacts of land management on aboveground and belowground edge effects, measured by changes in plant community, soil properties, and soil microbial communities across agroecosystem edges. We measured plant composition and biomass, soil properties (total carbon, total nitrogen, pH, nitrate, and ammonium), and soil fungal and bacterial community composition across perennial grassland-annual cropland edges.

Post-exertional malaise among people with long COVID compared to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Background: Long COVID describes a condition with symptoms that linger for months to years following acute COVID-19. Many of these Long COVID symptoms are like those experienced by patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).

Objective: We wanted to determine if people with Long COVID experienced post-exertional malaise (PEM), the hallmark symptom of ME/CFS, and if so, how it compared to PEM experienced by patients with ME/CFS.

Developing guidance for a risk-proportionate approach to blinding statisticians within clinical trials: a mixed methods study.

Background: Existing guidelines recommend statisticians remain blinded to treatment allocation prior to the final analysis and that any interim analyses should be conducted by a separate team from the one undertaking the final analysis. However, there remains substantial variation in practice between UK Clinical Trials Units (CTUs) when it comes to blinding statisticians. Therefore, the aim of this study was to develop guidance to advise CTUs on a risk-proportionate approach to blinding statisticians within clinical trials.

Assessment and management of allosensitization following heart transplant in adults.

Immunological injury to the allograft, specifically by antibodies to de novo donor specific human leukocyte antigen (dnDSA) and antibody mediated injury and rejection are the major limitations to graft survival after heart transplantation (HT). As such, our approach to allosensitization remains limited by the inability of contemporaneous immunoassays to unravel pathogenic potential of dnDSA. Additionally, the role of dnDSA is continuously evaluated with emerging methods to detect rejection.