MASH Resolution Index: development and validation of a non-invasive score to detect histological resolution of MASH.

Background: Dynamic changes in non-invasive tests, such as changes in alanine aminotransferase (ALT) and MRI proton-density-fat-fraction (MRI-PDFF), may help to detect metabolic dysfunction-associated steatohepatitis (MASH) resolution, but a combination of non-invasive tests may be more accurate than either alone. We developed a novel non-invasive score, the MASH Resolution Index, to detect the histological resolution of MASH.

Methods: This study included a derivation cohort of 95 well-characterised adult participants (67% female) with biopsy-confirmed MASH who underwent contemporaneous laboratory testing, MRI-PDFF and liver biopsy at two time points.

Population Pharmacokinetics and Pharmacodynamics of Pegozafermin in Patients with Nonalcoholic Steatohepatitis.

Pegozafermin is a long-acting glycoPEGylated analog of fibroblast growth factor 21 (FGF21) in development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia. In a phase Ib/IIa placebo-controlled, double-blind, multiple ascending dose study in patients with NASH (NCT04048135), administration of pegozafermin resulted in clinically meaningful reductions in hepatic fat fraction (HFF), with a favorable safety and tolerability profile. We aimed to characterize the relationship between pegozafermin dosing, exposure and effects on HFF reduction.

The Novel GlycoPEGylated FGF21 Analog Pegozafermin Activates Human FGF Receptors and Improves Metabolic and Liver Outcomes in Diabetic Monkeys and Healthy Human Volunteers.

Pegozafermin (also known as BIO89-100) is a glycoPEGylated analog of fibroblast growth factor 21 (FGF21) under development to treat nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). In cell-based assays, pegozafermin had a similar receptor engagement profile as recombinant FGF21, with approximately eightfold higher potency at fibroblast growth factor receptor 1c (FGFR1c). In diabetic monkeys, once-weekly and once-every-2-weeks regimens of subcutaneous pegozafermin provided rapid and robust benefits for an array of metabolic biomarkers, including triglycerides, cholesterol, fasting glucose, glycated hemoglobin, adiponectin, alanine aminotransferase, food intake, and body weight.

Post-traumatic Growth: The Roles of the Sense of Entitlement, Gratitude and hope.

People believe that they are entitled to well-being and safety, and their responses to unexpected traumatic events reveal individual differences. Their reactions vary, from feeling blocked and distressed to feeling proactive towards new growth, depending on their personal resources. The current study sought to identify the role of entitlement in explaining post-traumatic growth (PTG) while considering the role of gratitude and hope as personal resources.

Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH.

Background: Pegozafermin is a long-acting glycopegylated (pegylated with the use of site-specific glycosyltransferases) fibroblast growth factor 21 (FGF21) analogue in development for the treatment of nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia. The efficacy and safety of pegozafermin in patients with biopsy-proven noncirrhotic NASH are not well established.

Methods: In this phase 2b, multicenter, double-blind, 24-week, randomized, placebo-controlled trial, we randomly assigned patients with biopsy-confirmed NASH and stage F2 or F3 (moderate or severe) fibrosis to receive subcutaneous pegozafermin at a dose of 15 mg or 30 mg weekly or 44 mg once every 2 weeks or placebo weekly or every 2 weeks.

Loneliness before and after COVID-19: Sense of Coherence and Hope as Coping Mechanisms.

The COVID-19 pandemic posed a major threat to public health, with long-lasting consequences for the daily habits and practices of people around the world. The combination of hazardous health conditions and extensive changes to people's daily routines due to lockdowns, social restrictions, and employment uncertainty have led to mental health challenges, reduced levels of subjective wellbeing, and increased maladaptive behaviors and emotional distress. Nevertheless, some studies have reported increased adaptive functioning and resilience after the pandemic, suggesting a more complex pattern of effects.

Safety, pharmacokinetics, and pharmacodynamics of pegozafermin in patients with non-alcoholic steatohepatitis: a randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study.

Background: Management strategies for non-alcoholic steatohepatitis (NASH) are based predominantly on lifestyle modification, with no approved disease-modifying drugs yet available. We aimed to evaluate the safety, pharmacokinetics, and pharmacodynamics of pegozafermin (BIO89-100), a glycoPEGylated FGF21 analogue, in participants with NASH.

Methods: This randomised, double-blind, placebo-controlled, phase 1b/2a multiple-ascending-dose study enrolled adults (aged 21-75 years) who had NASH with stage F1-F3 fibrosis, or non-alcoholic fatty liver disease and a high risk of NASH (referred to in this study as phenotypic NASH) due to central obesity with type 2 diabetes, or central obesity with increased alanine aminotransferase (ALT) or a Fibroscan score of 7 kPa or greater, across 12 specialist centres and clinics in the USA.

The hope theory and specific learning disorders and/or attention deficit disorders (SLD/ADHD): Developmental perspectives.

Research on disabilities has generally used a deficit-oriented approach. However, the recent appreciation of the personal strengths and positive traits of the disabled has raised awareness of them as empowering and activating factors. According to the hope theory, the ability to embrace future perspectives, set meaningful goals, and plan specific paths to reach these goals predict well-being and adjustment.

Learning Difficulties and Loneliness in College and Beyond: The Mediating Role of Self-Efficacy, Proactive Coping, and Hope.

Following the conservation of resources, social-cognitive and hope theories, the goals of this study were to identify the role of self-efficacy, proactive coping, and hope as mediators in the relations between learning difficulties and loneliness distress. A questionnaire was sent to current and past students. The sample consisted of 498 participants.

Perceived social support, loneliness, and hope during the COVID-19 Pandemic: Testing a mediating model in the UK, USA, and Israel.

Objectives: The COVID-19 epidemic is affecting the entire world and hence provides an opportunity examine how people from different countries engage in hopeful thinking. The aim of this study was to examine the potentially facilitating role of perceived social support vis-à-vis hope as well as the mediating role of loneliness between perceived social support and hope. This mediating model was tested concurrently in the UK, the USA, and Israel.

Social participation and posttraumatic growth: The serial mediation of hope, social support, and reappraisal.

In light of the global crisis created by the outbreak of the coronavirus and the disease it causes, coronavirus disease 2019, the goal of the study was to detect factors that might enhance people's ability to experience positive psychological change during traumatic events. As such, this study examined the relationship between social participation and posttraumatic growth (PTG) during the coronavirus outbreak and tested the mediating role of hope, social support, and cognitive reappraisal in explaining this relationship. The sample consisted of 275 participants (21.

COVID-19-Related Economic Anxiety Is As High as Health Anxiety: Findings from the USA, the UK, and Israel.

As the COVID-19 outbreak peaks, millions of individuals are losing their income, and economic anxiety is felt worldwide. In three different countries (the USA, the UK, and Israel:  = 1200), the present study addresses four different sources of anxiety: health-related anxiety, economic-related anxiety, daily routine-change anxiety, and anxiety generated by social isolation. We hypothesized that, economic anxiety would have a similar or greater effect, compared to health anxiety.

Sense of coherence and burnout among school psychologists: The moderating role of loneliness.

School psychologist have been considered at a high risk for developing work burnout due to their multiple responsibilities, overload and engagement in caring for children, families and professionals. In line with the salutogenic approach, the aim of the current research was to investigate protective and risk factors to burnout. Research has indicated that sense of coherence (SOC) may act as a protective factor.

Hope, Loneliness and Sense of Coherence among Bereaved Parents.

Coping with the loss of a child is a challenging and difficult experience that disrupts the lives of the surviving parents and the fabric of the family. Our goal is to identify the factors that help bereaved parents cope with this loss and introduce hope and future perspectives into their lives. Our sample consisted of 81 parents (30 fathers and 51 mothers), who completed questionnaires on the following topics: family climate, loneliness, sense of coherence and hope.

Does Family Cohesion Predict Children's Effort? The Mediating Roles of Sense of Coherence, Hope, and Loneliness.

The degree of cohesion and support within families has often been considered a predictor of students' effort-investment and success in school. The objectives of this study are to examine the roles of personal factors (i.e.

Laquinimod Safety Profile: Pooled Analyses from the ALLEGRO and BRAVO Trials.

Background: Laquinimod 0.6 mg is a once-daily, oral, disease-modifying therapy in development for the treatment of multiple sclerosis (MS) that was investigated in two double-blind, placebo-controlled, phase 3 trials: ALLEGRO and BRAVO.

Methods: Data from these studies were pooled to assess the safety profile of laquinimod versus placebo.