Resistance Training and Nutritional Supplementation in Older Adults with Sarcopenia after Acute Disease: A Feasibility Study.

Resistance exercise and protein supplementation are recognized as effective treatment strategies for age-related sarcopenia; however, there are limited data on their feasibility, tolerability, and safety. The primary outcome of this study was feasibility, evaluated through the 15-item TELOS (Technological, Economics, Legal, Operational, and Scheduling) feasibility components and by recruitment, retention, and consent rates. Tolerability was measured by examining permanent treatment discontinuation, treatment interruption, exercise dose modification, early termination, rescheduling of missed sessions, losses to follow-up, attendance, and nutritional compliance.

Early life adversity drives sex-dependent changes in 5-mC DNA methylation of parvalbumin cells in the prefrontal cortex in rats.

Early life adversity (ELA) can result in increased risk for developing affective disorders, such as anxiety or depression, later in life, with women showing increased risk. Interactions between an individual's genes and their environment play key roles in producing, as well as mitigating, later life neuropathology. Our current understanding of the underlying epigenomic drivers of ELA associated anxiety and depression are limited, and this stems in part from the complexity of underlying biochemical processes associated with how early experiences shapes later life behavior.

NeuroEPO plus (NeuralCIM) in mild-to-moderate Alzheimer's clinical syndrome: the ATHENEA randomized clinical trial.

Background: NeuroEPO plus is a recombinant human erythropoietin without erythropoietic activity and shorter plasma half-life due to its low sialic acid content. NeuroEPO plus prevents oxidative damage, neuroinflammation, apoptosis and cognitive deficit in an Alzheimer's disease (AD) models. The aim of this study was to assess efficacy and safety of neuroEPO plus.

Sexual and reproductive health and access: Results of a rapid epidemiological assessment among migrant peoples in transit through Darién, Panamá.

Background: The foot transit of migrant peoples originating from the Caribbean, South America, Asia, and Sub-Saharan Africa through the Darién Forest (DF) in Eastern Panamá towards North America has increased in recent years from approximately 30,000 people/year to >133,000 in 2021. In the DF, there is no food/housing provision nor healthcare access. Very little is known of sexual and reproductive health (SRH) among this population.

High incidence of plastic debris in Andean condors from remote areas: Evidence for marine-terrestrial trophic transfer.

Plastic pollution is an alarming environmental problem affecting diverse species worldwide. Scavenging birds are currently exposed to plastic due to contamination of their food sources. Here, we evaluated the ingestion of plastic by a threatened top scavenger, the Andean condor (Vultur gryphus), and the potential origin of the plastic.

Neuropsychological Correlates of Changes in Driving Behavior Among Clinically Healthy Older Adults.

Objectives: To determine the extent to which cognitive domain scores moderate change in driving behavior in cognitively healthy older adults using naturalistic (Global Positioning System-based) driving outcomes and to compare against self-reported outcomes using an established driving questionnaire.

Methods: We analyzed longitudinal naturalistic driving behavior from a sample (N = 161, 45% female, mean age = 74.7 years, mean education = 16.

Thymic Polypeptide Fraction Biomodulina T Decreases Exhausted and Terminally Differentiated EMRA T Cells in Advanced Lung Cancer Patients Treated With Platinum-Based Chemotherapy.

Lung cancer is the second cause of cancer related deaths worldwide. Chemotherapy and immunotherapy represent the current standard of care for advanced NSCLC. Platinum-based chemotherapy expands late-differentiated T cell populations.

Evaluating the Feasibility and Validity of a New Tool to Assess Organizational Preparedness and Capabilities to Support Patient Engagement in Drug Development.

Interest in patient-centric initiatives to engage patients as partners in clinical research and inform drug development strategy, planning and execution has increased exponentially during the past decade. Adoption, use, organizational approach and infrastructure supporting patient-centric initiatives, however, varies widely from company to company. The Drug Information Association (DIA) in collaboration with the Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine developed and validated an assessment tool that companies can use to evaluate their organization's patient engagement preparedness and capabilities within the context of industry-wide practices.

The ALPHA Project: Establishing consensus and prioritisation of global community recommendations to address major challenges in lupus diagnosis, care, treatment and research.

The Addressing Lupus Pillars for Health Advancement (ALPHA) Project is a global consensus effort to identify, prioritise and address top barriers in lupus impacting diagnosis, care, treatment and research. To conduct this process, the ALPHA Project convened a multistakeholder Global Advisory Committee (GAC) of lupus experts and collected input from global audiences, including patients. In phase I, the ALPHA Project used expert interviews and a global survey of lupus experts to identify and categorise barriers into three overarching pillars: drug development, clinical care and access to care.

Postpartum mood among universally screened high and low socioeconomic status patients during COVID-19 social restrictions in New York City.

The mental health effects of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the Coronavirus Disease 2019 (COVID-19) pandemic on postpartum women are of increasing concern among mental health practitioners. To date, only a handful of studies have explored the emotional impact of the pandemic surrounding pregnancy and none have investigated the consequence of pandemic-related social restrictions on the postpartum mood of those living among different socioeconomic status (SES). All postpartum patients appearing to the Mount Sinai Health System for their postpartum appointment between January 2, 2020 and June 30, 2020, corresponding to before and during pandemic imposed social restrictions, were screened for mood symptomatology using the Edinburgh Postnatal Depression Scale (EPDS).

Assessing Patient Participation Burden Based on Protocol Design Characteristics.

Background: Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials.

Methods: This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures.

Establishing Consensus Understanding of the Barriers to Drug Development in Lupus.

Objective: Due to the extreme heterogeneity of lupus and the lack of consensus among stakeholders, pharmaceutical and biotechnology companies have had limited success in developing treatments for lupus. For this reason, the Lupus Foundation of America (LFA), researchers at the Center for the Study of Drug Development at Tufts University School of Medicine (Tufts CSDD) and an advisory committee of 13 international lupus experts collaborated to launch the Addressing Lupus Pillars for Health Advancement (ALPHA) project.

Methods: To inform the ALPHA project, 17 in-depth interviews among lupus experts and a global survey among lupus drug development and clinical care professionals was conducted to identify, characterize, and prioritize fundamental barriers and validate findings.

Quantifying Patient Subpopulation Disparities in New Drugs and Biologics Approved Between 2007 and 2017.

Background: Tufts CSDD conducted a study to quantify the magnitude of participant subgroup demographic disparities in industry-funded pivotal trials and establish baseline participant diversity measures.

Methods: Eleven years of data on pivotal trials of all novel drugs and biologics approved between 2007 and 2017 (n = 341 drugs and n = 757 pivotal trials) was compiled and analyzed.

Results: The availability of reported participant demographic subgroup data was poor-most notably participant ethnicity with 63% of pivotal trials supporting all approved treatments missing data.

Acute respiratory failure among lung transplant adults requiring intensive care: Changing spectrum of causative organisms and impact of procalcitonin test in the diagnostic workup.

Background: The aim was to identify the causing organisms and assess the association of procalcitonin (PCT) with bacterial pneumonia within 24 hours of intensive care unit admission (ICU-A) among lung transplant (LT) adult recipients.

Methods: Secondary analysis from a prospective cohort study. All LT adults admitted to ICU for acute respiratory failure (ARF) over 5 years were included.

Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases.

We gathered data from three pipeline databases and other public sources on development stage and clinical trial metrics for 1,914 investigational drugs, biologics, and vaccines and 2,769 clinical trials intended to treat a wide variety of infectious diseases. We included new molecular entities (NMEs), new formulations, and new combinations. Clinical trial times decreased from 2000-2008 to 2009-2017, varied by disease class, and were longer for trials with more subjects or more sites.

Assessing Biopharmaceutical Company Experience with Patient-centric Initiatives.

Purpose: A growing number of biopharmaceutical companies have been implementing patient-centric initiatives (PCIs). The Drug Information Association (DIA) and the Tufts Center for the Study of Drug Development (CSDD) collaborated on a study to gather data on the usage and impact of these PCIs to characterize company experience and impact.

Methods: DIA and Tufts CSDD collaborated with 17 organizations to define PCIs used in clinical research and development and to quantify their use, and to define metrics in use to document impact and return on engagement (ROE) for these PCIs.

Assessing Patient Participation Burden Based on Protocol Design Characteristics.

Background: Although a number of studies have quantitatively measured investigative site burden to administer increasingly complex protocol designs, robust scholarly research has not been performed to quantify the burden that patients face as participants in clinical trials.

Methods: This paper presents the results of a cross-sectional pilot study conducted by the Tufts Center for the Study of Drug Development and ZS Associates among nearly 600 patients via an online survey conducted between February and March 2019. Respondents rated the perceived burden of 60 commonly administered protocol procedures.

Global consensus building and prioritisation of fundamental lupus challenges: the ALPHA project.

Objective: Lupus is a complex, heterogeneous autoimmune disease that has yet to see significant progress towards more timely diagnosis, improved treatment options for short-term and long-term outcomes, and appropriate access to care. The Addressing Lupus Pillars for Health Advancement (ALPHA) project is the first step in establishing global consensus and developing concrete strategies to address the challenges limiting progress.

Methods: A Global Advisory Committee of 13 individuals guided the project and began barrier identification.

Improvement in thallium hydride generation using iodide and Rhodamine B.

A continuous flow hydride generation atomic absorption spectrometry (CF-HG-AAS) system was used to study the enhancement effect of different substances for conventional chemical HG of thallium. At room temperature, the acidified sample solution containing the respective enhancement reagent merged with the aqueous NaBH4 solution. The generated thallium hydride was stripped from the eluent solution by the addition of a nitrogen flow and thereafter the bulk phases were separated in a gas-liquid separator.

Immunoscintigraphy and radioimmunotherapy in Cuba: experiences with labeled monoclonal antibodies for cancer diagnosis and treatment (1993-2013).

INTRODUCTION The availability of monoclonal antibodies in Cuba has facilitated development and application of innovative techniques (immunoscintigraphy and radioimmunotherapy) for cancer diagnosis and treatment. Objective Review immunoscintigraphy and radioimmunotherapy techniques and analyze their use in Cuba, based on the published literature. In this context, we describe the experience of Havana's Clinical Research Center with labeled monoclonal antibodies for cancer diagnosis and treatment during the period 1993-2013.

Effect of yoga exercise therapy on oxidative stress indicators with end-stage renal disease on hemodialysis.

Background: Oxidative stress promotes endothelial dysfunction and atherosclerosis in chronic renal disease.

Objectives: This study investigated the impact of Hatha yoga on oxidative stress indicators and oxidant status, in patients with end-stage renal disease (ESRD) on hemodialysis.

Design: This prospective randomized study consisted of 33 ESRD patients in the Hatha yoga exercise group who were matched with 35 ESRD patients in the control group.

Access to antiepileptic drug therapy in children in Camagüey Province, Cuba.

Objective: To describe access to antiepileptic drug therapy and estimate the prevalence of epilepsy in children in Camagüey Province, Cuba.

Methods: All the community pharmacies in the province were visited and information collected about the number of children receiving antiepileptic drugs in 2009. Availability and cost of each antiepileptic drug were determined.

Effect of exercise therapy on lipid parameters in patients with end-stage renal disease on hemodialysis.

Background: Dyslipidemia has been established as a well-known traditional risk factor for cardiovascular disease in chronic kidney disease patients.

Aim: This study investigated the impact of Hatha yoga exercise on lipid parameters in patients with end-stage renal disease (ESRD) on hemodialysis.

Materials And Methods: This prospective randomized study consisted of 33 ESRD patients in the Hatha yoga exercise group that was matched with 35 ESRD patients in the control group.