Evaluation of the Effectiveness and Efficiency of the East African Community Joint Assessment Procedure by Member Countries: The Way Forward.

For almost a decade, the East African Community has implemented the Medicines Regulatory Harmonization (EAC-MRH) programme among its member states to harmonise technical requirements and standards for medical products regulation, jointly conduct scientific review of medical product dossiers to assess safety, efficacy and quality, inspect pharmaceutical manufacturing sites and streamline decision-making processes. This initiative enables the cost-effective use of limited resources and efficient and effective delivery of regulatory services to be determined, thus instilling transparency and accountability in all stakeholders, optimising the pharmaceutical market and economic development and improving access to safe, high-quality, effective medicines in the region. The aim of this study was to evaluate the effectiveness and efficiency of the current operating model of the EAC-MRH initiative, including challenges faced and to identify opportunities for improvement.

Spectra analysis and live-neuron imaging of cyclic AMP binding domain fusing circularly permutated GFP: Data for violet light excitable cyclic AMP indicator.

Cyclic adenosine monophosphate (cyclic AMP) is a second messenger, which is involved in the regulation of various cellular processes, including neuronal firing rate, synaptic plasticity, axon formation and axon elongation in brain. Although the main molecules in the cAMP-mediated signaling pathway are well studied, the spatio-temporal dynamics of the cAMP remain to be elucidated. Live imaging is an informative tool to investigate the cell signaling dynamics.

Knowledge and Use of Over-the-counter Drugs in Italy: An Exploratory Survey-based Study in the General Population.

Background: During the past decade, the misuse of over-the-counter (OTC) medicines has become a global public health concern, especially among young people. In this study, we aimed to explore the OTC consumption and related misuse in Italy and identify the demographic characteristics of people/individuals involved in this phenomenon, understanding eventual risk factors.

Methods: The study consisted of an anonymous online survey distributed by direct contact and via the Internet between June-November 2021 to the general population living in Italy.

In silico studies on recreational drugs: 3D quantitative structure activity relationship prediction of classified and de novo designer benzodiazepines.

Currently, increasing availability and popularity of designer benzodiazepines (DBZDs) constitutes a primary threat to public health. To assess this threat, the biological activity/potency of DBZDs was investigated using in silico studies. Specific Quantitative Structure Activity Relationship (QSAR) models were developed in Forge™ for the prediction of biological activity (IC ) on the γ-aminobutyric acid A receptor (GABA-AR) of previously identified classified and unclassified DBDZs.

Prevalence and Predictors of Potentially Inappropriate Medications Among Patients Aged ≥65 Years on Hospital Admissions in Kuwait.

Background: Potentially inappropriate medications are major health concerns for patients aged ≥65 years. To investigate the prevalence of potentially inappropriate medications, Beer's criteria can be used. We estimated the prevalence of potentially inappropriate medications prescription among patients aged ≥65 years admitted to Kuwait's largest hospital and identified the predictors of prescribing a potentially inappropriate medication.

Right Ventricular Free Wall Rupture Complicating Anterior STEMI.

Ventricular free wall rupture is a rare but devastating complication. We report right ventricular free wall rupture complicating anterior ST-segment elevation myocardial infarction caused by a wrap-around left anterior descending coronary artery. In acute cardiac tamponade, a rapid and systematic evaluation of the likely source of bleeding is paramount to prevent disastrous outcomes.

The increasing indications of FDG-PET/CT in the staging and management of Invasive Bladder Cancer.

The management of locally advanced muscle invasive bladder cancer (MIBC) often necessitates neo-adjuvant chemotherapy (NAC) to eliminate any micro-metastatic disease prior to definitive radical cystectomy (RC) and pelvic lymph node dissection (PLND). The most common imaging techniques traditionally used during this process are computerised tomography (CT) and magnetic resonance imaging (MRI), both of which lack a high sensitivity for nodal staging. In this paper, we attempt to review the evolving indications of F-fluoro-2-deoxy-D-glucose positron emission tomography/computerised tomography (FDG-PET/CT) imaging, in the pre-clinical and post-treatment staging of bladder cancer, with a focus on its ability to evaluate response to NAC.

Distribution of surgical smoke particles within a simulated laparoscopic cavity utilizing an AirSeal system.

An exploratory study was performed to determine the distribution of surgical smoke particulate matter (SSPM) and evacuation times within an AirSeal System and a traditional insufflation access system in various simulated surgical scenarios. Identified trends showed statistical significance when setting the AirSeal System to Low smoke evacuation that it reduces the percentage of particulate matter at the Access Port opening. Additionally, it was observed that when utilising a laparoscopic tool a similar trend in particle distributions were seen between either insufflation and access system at the opening of the Access Port and trocar.

Predicting the Degree of Distracted Driving Based on fNIRS Functional Connectivity: A Pilot Study.

Distracted driving is one of the main causes of traffic accidents. By predicting the attentional state of drivers, it is possible to prevent distractions and promote safe driving. In this study, we developed a model that could predict the degree of distracted driving based on brain activity.

A unique peptide-based pharmacophore identifies an inhibitory compound against the A-subunit of Shiga toxin.

Shiga toxin (Stx), a major virulence factor of enterohemorrhagic Escherichia coli (EHEC), can cause fatal systemic complications. Recently, we identified a potent inhibitory peptide that binds to the catalytic A-subunit of Stx. Here, using biochemical structural analysis and X-ray crystallography, we determined a minimal essential peptide motif that occupies the catalytic cavity and is required for binding to the A-subunit of Stx2a, a highly virulent Stx subtype.

Assessment and Mitigation of Bleeding Risk in Atrial Fibrillation and Venous Thromboembolism: Executive Summary of a European and Asia-Pacific Expert Consensus Paper.

While there is a clear clinical benefit of oral anticoagulation in patients with atrial fibrillation (AF) and venous thromboembolism (VTE) in reducing the risks of thromboembolism, major bleeding events (especially intracranial bleeds) may still occur and be devastating. The decision for initiating and continuing anticoagulation is often based on a careful assessment of both thromboembolism and bleeding risk. The more common and validated bleeding risk factors have been used to formulate bleeding risk stratification scores, but thromboembolism and bleeding risk factors often overlap.

From EGFR kinase inhibitors to anti-inflammatory drugs: Optimization and biological evaluation of (4-(phenylamino)quinazolinyl)-phenylthiourea derivatives as novel NF-κB inhibitors.

The transcription factor NF-κB is a pivotal mediator of chronic inflammatory and autoimmune diseases. Based on our previously published dual EGFR/NF-κB inhibitors, we designed and synthesized new thiourea quinazoline derivatives that retained only the NF-κB inhibitory activity. Several congeners displayed a strong suppression of NF-κB activity in a reporter gene assay, yet low cytotoxicity, and were further evaluated in differentiated macrophage-like THP-1 cells.

Patient Satisfaction with Pharmaceutical Services in Makkah: A Cross-sectional Study.

Objective: Patient satisfaction is considered an essential indicator of the treatment outcomes of pharmaceutical services. This study aimed to assess patient satisfaction with the pharmaceutical services at the Ministry of Health (MOH) hospitals in Makkah city in Saudi Arabia.

Methods: A cross-sectional study was conducted via an interview-based questionnaire that involved patients who visited the outpatient pharmacy in five MOH hospitals from August 2018 to September 2018.

Childhood trauma and schizotypy in non-clinical samples: A systematic review and meta-analysis.

The association of early life adversities and psychosis symptoms is well documented in clinical populations; however, whether this relationship also extends into subclinical psychosis remains unclear. In particular, are early life adversities associated with increased levels of schizotypal personality traits in non-clinical samples? We conducted a systematic review and meta-analysis of associations between early life adversities and psychometrically defined schizotypal traits in non-clinical samples. The review followed PRISMA guidelines.

Development of a New Dislodgeable Foliar Residue Analytical Laboratory Method for Pesticides.

The dislodgeable foliar residue (DFR) is the amount of pesticide that exists on foliage after the pesticide has dried and which could dislodge to the skin or clothes of workers and is a key parameter for non-dietary risk assessments required to demonstrate safe use for pesticide registration. DFR data in the literature are described as insufficiently reliable, limited, and encompasses considerable statistical uncertainties. The purpose of this article is to describe a newly developed laboratory method for the quantification of DFR with an illustrative example.

Atypical Antipsychotic Drugs in Dual Disorders: Current Evidence for Clinical Practice.

Background: Concurrent disorder or dual diagnosis refers to a combination of substance use disorders and mental disorders that occur in the same patient simultaneously. These conditions pose significant clinical and healthcare impacts and are often underdiagnosed, undertreated, and complex to manage.

Objective: We assessed the quality of current pharmacological recommendations for the management of dual diagnosis, particularly by evaluating the use of second-generation antipsychotics (SGA).

A Randomized Trial Directly Comparing Ventral Capsule and Anteromedial Subthalamic Nucleus Stimulation in Obsessive-Compulsive Disorder: Clinical and Imaging Evidence for Dissociable Effects.

(Appeared originally in Biological Psychiatry 2019; 85:726-734) Reprinted under Creative Commons CC-BY license.

Pharmacovigilance Signals of the Opioid Epidemic over 10 Years: Data Mining Methods in the Analysis of Pharmacovigilance Datasets Collecting Adverse Drug Reactions (ADRs) Reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS).

In the past twenty years, the consumption of opioid medications has reached significant proportions, leading to a rise in drug misuse and abuse and increased opioid dependence and related fatalities. Thus, the purpose of this study was to determine whether there are pharmacovigilance signals of abuse, misuse, and dependence and their nature for the following prescription opioids: codeine, dihydrocodeine, fentanyl, oxycodone, pentazocine, and tramadol. Both the pharmacovigilance datasets EudraVigilance (EV) and the FDA Adverse Events Reporting System (FAERS) were analyzed to identify and describe possible misuse-/abuse-/dependence-related issues.

Design of Novel Enantiopure Dispirooxindolopyrrolidine-Piperidones as Promising Candidates toward COVID-19: Asymmetric Synthesis, Crystal Structure and Studies.

Despite the effectiveness of COVID-19 vaccines, there is still an urgent need for discovering new anti-viral drugs to address the awful spread and transmission of the rapidly modifiable virus. In this study, the ability of a small library of enantiomerically pure spirooxindolopyrrolidine-grafted piperidones to inhibit the main protease of SARS-CoV-2 (M) is evaluated. These spiroheterocycles were synthesized by 1,3-dipolar cycloaddition of various stabilized azomethine ylides with chiral dipolarophiles derived from [-(-)-methylbenzyl]-4-piperidone.

Acute Dehydration Impairs Performance and Physiological Responses in Highly Trained Judo Athletes.

Background: The present study investigated highly trained male judo athletes and how a 5% body mass dehydration affects their judo-specific performance and physiological responses. Methods: Nine highly trained international-level male judo athletes who are weight-cyclers voluntarily participated in the study. The study had a controlled crossover design in nature.

Percutaneous Coronary Intervention of Native Artery Versus Bypass Graft in Patients with Prior Coronary Artery Bypass Graft Surgery.

Background: Percutaneous coronary intervention (PCI) is common in patients with prior coronary artery bypass graft surgery (CABG), however, there is limited data on the association between the PCI target-vessel and clinical outcomes. In this article, we provide a state-of-the-art overview of the contemporary management of patients with prior CABG and a clear indication for revascularization.

Methods: We performed a structured literature search of PubMed and Cochrane Library databases from inception to March 2021.

The use of social robots with children and young people on the autism spectrum: A systematic review and meta-analysis.

Background: Robot-mediated interventions show promise in supporting the development of children on the autism spectrum.

Objectives: In this systematic review and meta-analysis, we summarize key features of available evidence on robot-interventions for children and young people on the autism spectrum aged up to 18 years old, as well as consider their efficacy for specific domains of learning.

Data Sources: PubMed, Scopus, EBSCOhost, Google Scholar, Cochrane Library, ACM Digital Library, and IEEE Xplore.

Novel Synthetic Opioids (NSO) Use in Opioid Dependents Entering Detoxification Treatment.

Introduction: Over the last decade, the use of New/Novel Synthetic Opioids (NSO) has emerged as an increasing problem, and especially so in the USA. However, only little is known about the prevalence and history of NSO use in European heroin dependents.

Method: A cross-sectional multicenter study, carried out with the means of both standardized interviews and urine toxicology enhanced screening, in a sample of opioid addicted patients referred for an in-patient detoxification treatment.