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AIMS Public Health 2021Geriatrics as an educational topic has been a high priority in current health care. The innovative Age-Friendly health system with the 4Ms structure (what Matters most,...
BACKGROUND
Geriatrics as an educational topic has been a high priority in current health care. The innovative Age-Friendly health system with the 4Ms structure (what Matters most, Medication, Mentation, Mobility) needs to be integrated into oral health and dental services training. The purpose of this study is to respond to one question: are the graduating general dentists trained and prepared to treat medically vulnerable elderly in communities?
METHODS
All pre-doctorate dental students from first year to fourth year were invited to voluntarily respond to an online survey provided on Qualtrics. The survey provided examples of two broken molar teeth that need extraction. First, students were asked how comfortable they felt extracting the two molars based on the x-rays. Then, the question was repeated to evaluate if they felt comfortable with extracting the teeth in a patient with one chronic condition and related medication(s). Finally, the students were again questioned whether they feel comfortable to provide the same service to medically vulnerable patients with multiple health conditions and polypharmacy.
RESULTS
The majority of students who participated in this study said they were comfortable with extracting the teeth of patients without any chronic condition. However, many more chose to refer medically vulnerable patients with multiple chronic conditions and polypharmacy to a specialist.
CONCLUSIONS
Dental education in many U.S. dental schools may provide adequate education and create competent general dentists. Yet, the competency and confidence required for dentists to be able to treat older adults with multiple health conditions and using prescribed or over-the-counter medication is insufficient.
PubMed: 34786428
DOI: 10.3934/publichealth.2021054 -
Challenges and opportunities for conducting pre-hospital trauma trials: a behavioural investigation.Trials Mar 2023Trials in pre-hospital trauma care are relatively uncommon. There are logistical and methodological challenges related to designing and delivering trials in this... (Clinical Trial)
Clinical Trial
BACKGROUND
Trials in pre-hospital trauma care are relatively uncommon. There are logistical and methodological challenges related to designing and delivering trials in this setting. Previous studies have assessed challenges reported in individual trials rather than across the pre-hospital trial landscape to identify over-arching factors. The aim of this study was to investigate the challenges and opportunities related to the set-up, design and conduct of pre-hospital trauma trials from across the pre-hospital trial landscape and a specific pre-hospital trauma feasibility study.
METHODS
Semi-structured interviews were conducted with two cohorts of participants: research personnel who had experience of pre-hospital trials, either through direct involvement in conduct or through strategic oversight of national initiatives (n = 7), and clinical staff (n = 16) involved in recruitment to a pre-hospital trauma feasibility study. Thematic analyses were used to assess the barriers and enablers of conducting pre-hospital trauma trials. Two frameworks (The Capability Opportunity Motivation-Behaviour and the Theoretical Domains Framework) were used to guide analyses.
RESULTS
The barriers and enablers reported were relevant to several TDF domains and COM-B components. Across both cohorts, challenges associated with opportunities were reported and included the lack of research experience amongst pre-hospital staff, team dynamics within a rotating shift schedule, and the involvement of external organisations with diverse institutional priorities and infrastructures (e.g. Air Ambulances). The infrequency of eligible cases was also reported to affect the trial design, set-up, and conduct. Other barriers reported related to clinical equipoise amongst staff and institutional pressures, which affected motivation.
CONCLUSIONS
This study has highlighted that pre-hospital trials face many context-specific but also generic challenges. Pre-hospital trauma trial teams could consider the findings to develop targeted, behaviourally focused, solutions to the challenges identified in order to enhance the set-up and conduct of trials in this setting.
TRIAL REGISTRATION
NCT04145271. Trial registration date: October 30, 2019. Note that this paper does not report results from a specific trial but does include participants who were involved in the conduct of a registered pre-hospital feasibility study.
Topics: Humans; Air Ambulances; Drugs, Generic; Health Facilities; Hospitals; Motivation
PubMed: 36864520
DOI: 10.1186/s13063-023-07184-5 -
European Journal of Pharmaceutical... May 2023Bilayer tablets offer various drug release profiles for individual drugs incorporated in each layer of a bilayer tablet, which is rarely achievable by conventional... (Review)
Review
Bilayer tablets offer various drug release profiles for individual drugs incorporated in each layer of a bilayer tablet, which is rarely achievable by conventional tablets. These tablets also help avoid physicochemical incompatibilities between drugs and excipients. Successful manufacturing of such more complex dosage forms depends upon screening of material attributes of API and excipients as well as optimization of processing parameters of individual unit operations of the manufacturing process that must be strictly monitored and controlled to obtain an acceptable drug product quality and performance in order to achieve safety and efficacy per regulatory requirements. Optimizing formulation attributes and manufacturing processes during critical stages, such as blending, granulation, pre-compression, and main compression, can help avoid problems such as weight variation, segregation, and delamination of individual layers, which are frequently faced during the production of bilayer tablets. The main objective of this review is to establish the basis for the implementation of Quality by Design (QbD) system principles for the design and development of bilayer tablets, encompassing the preliminary and systematic risk assessment of critical material attributes (CMAs) and critical process parameters (CPPs) with respect to in-process and finished product critical quality attributes (CQAs). Moreover, the applicability of the QbD methodology based on its purpose is discussed and complemented with examples of bilayer tablet technology.
Topics: Excipients; Tablets; Drug Liberation; Technology, Pharmaceutical; Drug Compounding
PubMed: 36828037
DOI: 10.1016/j.ejps.2023.106412 -
Molecules (Basel, Switzerland) Jan 2023Central nervous system (CNS) disorders are a therapeutic area in drug discovery where demand for new treatments greatly exceeds approved treatment options. This is... (Review)
Review
Central nervous system (CNS) disorders are a therapeutic area in drug discovery where demand for new treatments greatly exceeds approved treatment options. This is complicated by the high failure rate in late-stage clinical trials, resulting in exorbitant costs associated with bringing new CNS drugs to market. Computer-aided drug design (CADD) techniques minimise the time and cost burdens associated with drug research and development by ensuring an advantageous starting point for pre-clinical and clinical assessments. The key elements of CADD are divided into ligand-based and structure-based methods. Ligand-based methods encompass techniques including pharmacophore modelling and quantitative structure activity relationships (QSARs), which use the relationship between biological activity and chemical structure to ascertain suitable lead molecules. In contrast, structure-based methods use information about the binding site architecture from an established protein structure to select suitable molecules for further investigation. In recent years, deep learning techniques have been applied in drug design and present an exciting addition to CADD workflows. Despite the difficulties associated with CNS drug discovery, advances towards new pharmaceutical treatments continue to be made, and CADD has supported these findings. This review explores various CADD techniques and discusses applications in CNS drug discovery from 2018 to November 2022.
Topics: Computer-Aided Design; Ligands; Drug Design; Psychotropic Drugs; Pharmaceutical Preparations
PubMed: 36770990
DOI: 10.3390/molecules28031324 -
Current Heart Failure Reports Dec 2023Cardiac tissue regenerative strategies have gained much traction over the years, in particular those utilizing hydrogels. With our review, and with special focus on... (Review)
Review
PURPOSE OF REVIEW
Cardiac tissue regenerative strategies have gained much traction over the years, in particular those utilizing hydrogels. With our review, and with special focus on supporting post-myocardial infarcted tissue, we aim to provide insights in determining crucial design considerations of a hydrogel and the implications these could have for future clinical use.
RECENT FINDINGS
To date, two hydrogel delivery strategies are being explored, cardiac injection or patch, to treat myocardial infarction. Recent advances have demonstrated that the mechanism by which a hydrogel is gelated (i.e., physically or chemically cross-linked) not only impacts the biocompatibility, mechanical properties, and chemical structure, but also the route of delivery of the hydrogel and thus its effect on cardiac repair. With regard to cardiac regeneration, various hydrogels have been developed with the ability to function as a delivery system for therapeutic strategies (e.g., drug and stem cells treatments), as well as a scaffold to guide cardiac tissue regeneration following myocardial infarction. However, these developments remain within the experimental and pre-clinical realm and have yet to transition towards the clinical setting.
Topics: Humans; Hydrogels; Prospective Studies; Heart Failure; Myocardial Infarction; Myocardium
PubMed: 37812347
DOI: 10.1007/s11897-023-00630-0 -
Ultrasonics Sonochemistry Jan 2022This study determined the influence of diacylglycerol (DAG) pre-emulsion on the gel properties and microstructure of golden thread surimi gels. DAG emulsion stabilized...
This study determined the influence of diacylglycerol (DAG) pre-emulsion on the gel properties and microstructure of golden thread surimi gels. DAG emulsion stabilized using sodium caseinate was pre-emulsified through ultrasound. The average particle size of DAG pre-emulsion decreased from 1324.15 nm to 41.19 nm, with notable improvements in apparent viscosity and storage stability. The surimi gels with different amounts (0%, 1%, 3%, 5%, and 7% w/w) of DAG pre-emulsion were prepared under heat induction. The whiteness of the composite gels markedly increased with the incorporation of DAG pre-emulsion. The peak T value of immobilized water, the gel strength, and water-holding capacity increased gradually, but it slightly decreased with the addition of 7% pre-emulsion. The curve of G' and G″ kept climbing as the concentration of pre-emulsion, and the microstructure of the gel network tended to become denser and more orderly. Principal component analysis (PCA) of electronic nose results showed that the surimi gels containing pre-emulsion could be clearly distinguished from the control group. In conclusion, the addition of 5% DAG pre-emulsion to surimi not only improved gel properties to the highest extent but also be compensated for lipid loss during the rinsing of surimi.
Topics: Diglycerides; Emulsions; Fish Products; Gels; Ultrasonics; Water
PubMed: 35042162
DOI: 10.1016/j.ultsonch.2022.105915 -
Journal of Neurotrauma Jul 2021There is not a single pharmacological agent with demonstrated therapeutic efficacy for traumatic brain injury (TBI). With recent legalization efforts and the growing... (Review)
Review
There is not a single pharmacological agent with demonstrated therapeutic efficacy for traumatic brain injury (TBI). With recent legalization efforts and the growing popularity of medical cannabis, patients with TBI will inevitably consider medical cannabis as a treatment option. Pre-clinical TBI research suggests that cannabinoids have neuroprotective and psychotherapeutic properties. In contrast, recreational cannabis use has consistently shown to have detrimental effects. Our review identified a paucity of high-quality studies examining the beneficial and adverse effects of medical cannabis on TBI, with only a single phase III randomized control trial. However, observational studies demonstrate that TBI patients are using medical and recreational cannabis to treat their symptoms, highlighting inconsistencies between public policy, perception of potential efficacy, and the dearth of empirical evidence. We conclude that randomized controlled trials and prospective studies with appropriate control groups are necessary to fully understand the efficacy and potential adverse effects of medical cannabis for TBI.
Topics: Brain Injuries, Traumatic; Cannabinoids; Humans; Medical Marijuana
PubMed: 33256496
DOI: 10.1089/neu.2020.7148 -
Journal of Controlled Release :... Sep 2023Microneedle Array Patches (MAPs) are an emerging dosage form that creates transient micron-sized disruptions in the outermost physical skin barrier, the stratum corneum,...
Microneedle Array Patches (MAPs) are an emerging dosage form that creates transient micron-sized disruptions in the outermost physical skin barrier, the stratum corneum, to facilitate delivery of active pharmaceutical ingredients to the underlying tissue. Numerous MAP products are proposed and there is significant clinical potential in priority areas such as vaccination. However, since their inception scientists have hypothesized about the risk of a clinically significant MAP-induced infection. Safety data from two major Phase 3 clinical trials involving hundreds of participants, who in total received tens of thousands of MAP applications, does not identify any clinically significant infections. However, the incumbent data set is not extensive enough to make definitive generalizable conclusions. A comprehensive assessment of the infection risk is therefore advised for MAP products, and this should be informed by clinical and pre-clinical data, theoretical analysis and informed opinions. In this article, a group of key stakeholders identify some of the key product- and patient-specific factors that may contribute to the risk of infection from a MAP product and provide expert opinions in the context of guidance from regulatory authorities. Considerations that are particularly pertinent to the MAP dosage form include the specifications of the finished product (e.g. microbial specification), it's design features, the setting for administration, the skill of the administrator, the anatomical application site, the target population and the clinical context. These factors, and others discussed in this article, provide a platform for the development of MAP risk assessments and a stimulus for early and open dialogue between developers, regulatory authorities and other key stakeholders, to expedite and promote development of safe and effective MAP products.
Topics: Humans; Administration, Cutaneous; Drug Delivery Systems; Epidermis; Needles; Pharmaceutical Preparations; Risk Assessment; Skin; Clinical Trials, Phase III as Topic
PubMed: 37437849
DOI: 10.1016/j.jconrel.2023.07.001 -
Acta Biomaterialia Sep 2021Pleural and tracheal injuries remain significant problems, and an easy to use, effective pleural or tracheal sealant would be a significant advance. The major challenges...
Pleural and tracheal injuries remain significant problems, and an easy to use, effective pleural or tracheal sealant would be a significant advance. The major challenges are requirements for adherence, high strength and elasticity, dynamic durability, appropriate biodegradability, and lack of cell or systemic toxicity. We designed and evaluated two sealant materials comprised respectively of alginate methacrylate and of gelatin methacryloyl, each functionalized by conjugation with dopamine HCl. Both compounds are cross-linked into easily applied as pre-formed hydrogel patches or as in situ hydrogels formed at the wound site utilizing FDA-approved photo-initiators and oxidants. Material testing demonstrates appropriate adhesiveness, tensile strength, burst pressure, and elasticity with no significant cell toxicity in vitro assessments. Air-leak was absent after sealant application to experimentally-induced injuries in ex-vivo rat lung and tracheal models and in ex vivo pig lungs. Sustained repair of experimentally-induced pleural injury was observed for up to one month in vivo rat models and for up to 2 weeks in vivo rat tracheal injury models without obvious air leak or obvious toxicities. The alginate-based sealant worked best in a pre-formed hydrogel patch whereas the gelatin-based sealant worked best in an in situ formed hydrogel at the wound site thus providing two potential approaches. These studies provide a platform for further pre-clinical and potential clinical investigations. STATEMENT OF SIGNIFICANCE: Pneumothorax and pleural effusions resulting from trauma and a range of lung diseases and critical illnesses can result in lung collapse that can be immediately life-threatening or result in chronic leaking (bronchopleural fistula) that is currently difficult to manage. This leads to significantly increased morbidity, mortality, hospital stays, health care costs, and other complications. We have developed sealants originating from alginate and gelatin biomaterials, each functionalized by methacryloylation and by dopamine conjugation to have desired mechanical characteristics for use in pleural and tracheal injuries. The sealants are easily applied, non-cytotoxic, and perform well in vitro and in vivo model systems of lung and tracheal injuries. These initial proof of concept investigations provide a platform for further studies.
Topics: Alginates; Animals; Biocompatible Materials; Gelatin; Hydrogels; Rats; Swine; Tissue Adhesives
PubMed: 34245891
DOI: 10.1016/j.actbio.2021.06.048 -
Advanced Drug Delivery Reviews 2020Considering the multifaceted protective and homeostatic roles of the complement system, many consequences arise when drug carriers, and particulate pharmaceutical... (Review)
Review
Considering the multifaceted protective and homeostatic roles of the complement system, many consequences arise when drug carriers, and particulate pharmaceutical formulations clash with complement proteins, and trigger complement cascade. Complement activation may induce formulation destabilization, promote opsonization, and affect biological and therapeutic performance of pharmaceutical nano- and micro-particles. In some cases, complement activation is beneficial, where complement may play a role in prophylactic protection, whereas uncontrolled complement activation is deleterious, and contributes to disease progression. Accordingly, design initiatives with particulate medicines should consider complement activation properties of the end formulation within the context of administration route, dosing, systems biology, and therapeutic perspective. Here we examine current progress in mechanistic processes underlying complement activation by pre-clinical and clinical particles, identify opportunities and challenges ahead, and suggest future directions in nanomedicine-complement interface research.
Topics: Animals; Complement Activation; Complement System Proteins; Drug Carriers; Humans; Microspheres; Nanoparticles; Pharmaceutical Preparations
PubMed: 32389761
DOI: 10.1016/j.addr.2020.04.012