Clinical Trial

Introduction: Women continue to be underrepresented in oncology clinical trials, leading to poor, underpowered subgroup analyses that cannot be generalized to cancer patients in practice. In 2014, the US Food and Drug Administration (FDA) released an Action Plan, which included actions to improve the quality and reporting of demographic subgroup data. We sought to evaluate the five-year progress since the release of this report by assessing the credibility of sex-specific subgroup analyses in oncology clinical trials.
Background: The impact of COVID-19 on physical and mental health and employment after hospitalisation with acute disease is not well understood. The aim of this study was to determine the effects of COVID-19-related hospitalisation on health and employment, to identify factors associated with recovery, and to describe recovery phenotypes.
Background: Criteria for low-dose CT scan lung cancer screening vary across guidelines. Knowledge of the eligible pool across demographic groups can enable policy and programmatic decision-making, particularly for disproportionately affected populations. Research Question: What are the eligibility rates for low-dose CT scan screening according to sex and race or ethnicity and how do these rates relate to corresponding lung cancer incidence rates?
Background: Ovarian cancer continues to have a poor prognosis with the majority of women diagnosed with advanced disease. Therefore, we undertook the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) to determine if population screening can reduce deaths due to the disease. We report on ovarian cancer mortality after long-term follow-up in UKCTOCS. Methods: In this randomised controlled trial, postmenopausal women aged 50–74 years were recruited from 13 centres in National Health Service trusts in England, Wales, and Northern Ireland.
Background: Disparities in outcomes of adult sepsis are well described by insurance status and race and ethnicity. There is a paucity of data looking at disparities in sepsis outcomes in children. We aimed to determine whether hospital outcomes in childhood severe sepsis were influenced by race or ethnicity and insurance status, a proxy for socioeconomic position. Methods: This population-based, retrospective cohort study used data from the 2016 database release from the Healthcare Cost and Utilization Project Kids’ Inpatient Database (KID).
Objective: Mental health and cognitive difficulties are highly prevalent across neurological disorders and significantly contribute to poorer patient outcomes. Unfortunately, access to effective psychological services for these comorbidities are limited. To determine whether a novel transdiagnostic internet-delivered psychological intervention, the Wellbeing Neuro Course, was feasible, acceptable and efficacious a single-group feasibility open trial was employed. Methods: The Wellbeing Neuro Course, targets mental health and cognitive difficulties, across a variety of neurological disorders.
Violence against women is a violation of human rights, crossing all cultures, classes, levels of education, earnings, ethnic and age groups. We conducted a retrospective study to review forensic records of sexual assault examinations carried out in different Italian health facilities and to correlate these findings with the results of the forensic DNA analyses.
Background: Recently, we reported that patients with mild cognitive impairment (MCI) harbor specific signature of bacteria in their gut and that a modified Mediterranean ketogenic diet (MMKD) improves Alzheimer's disease (AD) markers in cerebrospinal fluid (CSF) and the signatures of gut bacteria. However, other microbial population such as gut fungi (mycobiome) in relation to MCI/AD pathology, gut bacteria and diet remain unknown.
Background: Innovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a facilitator-guided, group-based, self-help intervention (Self-Help Plus) to reduce psychological distress in female refugees. Methods: We did a cluster randomised trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6).
Background: Innovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a facilitator-guided, group-based, self-help intervention (Self-Help Plus) to reduce psychological distress in female refugees. Methods: We did a cluster randomised trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6).

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