Clinical Research Services

Pharmacists are poised to play a continued, and likely expanded, pivotal role in immunization advocacy, selection, and administration. As trusted healthcare professionals, pharmacists can address hesitancy by using evidencebased communication strategies such as motivational interviewing to explore concerns, build trust, and guide patients toward informed decisions.

This study investigates the impact of the Coronavirus disease 2019 (COVID-19) pandemic on orthodontically associated cleft lip/palate and craniofacial surgeries, focusing on lip repairs, alveolar bone grafting (ABG), and orthognathic surgeries (OGS). A retrospective chart review of 571 participants in a single hospital setting who underwent surgical lip repairs, ABG or OGS was conducted. Clinical data were retrieved from patients' electronic medical records. The data were used to quantify and compare the number of surgeries and surgical wait times pre-COVID versus post-COVID, using independent t tests and regression models, adjusting for various sociodemographic and clinical variables. The proportion of lip repairs and ABG performed was not significantly different between the pre-COVID and post-COVID (P=0.90 and 0.94, respectively); however, OGS significantly decreased post-COVID compared with pre-COVID (P<0.0001). Although no significant differences were found in surgical wait times for lip repairs across time periods (P=0.07), wait times for both ABG and OGS were significantly longer post-COVID compared with pre-COVID (both P<0.0001). Regression analyses showed similar associations after adjusting for several covariates. COVID-19 significantly impacted ABG and OGS procedures. Prolonged surgical wait times raise concerns regarding adverse outcomes on patients' physical and mental health. Emphasis should be placed on prioritizing essential procedures and implementing flexible scheduling. Further research is needed to assess the long-term effects of these delays on patient-centered outcomes.

Obesity and type 2 diabetes mellitus (T2D) are widespread diseases that significantly impact cardiovascular and renal morbidity and mortality. In the recent years, intensive research has been performed to assess the role of adipose tissue and body fat distribution in the development of metabolic and non-metabolic complications in individuals with obesity. In addition to lifestyle modifications, glucagon-like peptide-1 receptor agonists (GLP-1-RA) have become a meaningful treatment expansion for the management of both disorders. In addition to improving metabolic control and reducing body weight, treatment with GLP-1-RAs reduces cardiovascular and renal events in individuals with obesity with and without diabetes. These important benefits of GLP-1-RAs have triggered new interest in other enteroendocrine and enteropancreatic peptides for treating obesity and its metabolic and non-metabolic consequences. The first peptide dual-agonist targeting glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptors has been approved for the treatment of T2D and obesity. GIP/GLP-1 dual-agonism appear to provide better metabolic control and greater weight reduction compared with GLP-1-R mono-agonism. Other peptide and non-peptide co-agonists are in clinical development for obesity, T2D, metabolic dysfunction-associated steatotic liver disease (MASLD) and other metabolic disorders. This narrative review aims to summarize the available data on approved and emerging enteroendocrine and enteropancreatic based treatment approaches for obesity and metabolic disorders. In addition to available clinical efficacy measures, side effects, limitations and open challenges will also be addressed.

Status Completed Start date August 2019 Completion date May 2025 InterdisciPlInary Collaboration for efficienT and effective Use of clinical images in big data healthcare RESearch Overview PICTURES (InterdisciPlInary Collaboration for efficienT and effective Use of clinical images in big data healthcare RESearch) was a 5-year MRC funded programme of work to enable international research access to highly heterogeneous, routinely collected, clinical images linked to patient outcomes. In 2022, the PICTURES team delivered the Scottish Medical Imaging (SMI) capability, providing safe and secure resources for health data research involving population-level real-world medical image data, that meets both the needs of researchers and strict data governance requirements. HIC's role - Prof Emily Jefferson, HIC Director at the time, drove development of the MRC bid and was Principal Investigator for the £2.8m PICTURES Grant. - Various work packages were led by HIC staff and their Senior Project Manager led delivery of the programme as a whole. - HIC developed the Research Data Management Platform (RDMP), an integral component of the Minimum Viable Product (MVP) technology upon which SMI was built. - HIC hosted one of the two exemplar projects, demonstrating portability of SMI outputs and enabling the development of a machine-learning pipeline for predicting future dementia diagnoses using routinely acquired MRI brain scans linked with medical records for Tayside and Fife patients from the consented SHARE cohort. Impact - Researchers now have access to over 1.5 petabytes of research-ready medical imaging data for the whole of Scotland, linked to electronic health records, through SMI in the Scottish National Safe Haven. - HIC are at the forefront of enabling image-based research at a regional level, working with data controllers to provision routinely collected image data from NHS Tayside’s Picture Archive and Communications System (PACS) within the East of Scotland Safe Haven hosted and managed by HIC. - The PICTURES programme of work led to related funding and projects like GRAIMatter, SACRO and SDC-Reboot. These initiatives focused on enabling safe egress of models trained on data intended to remain within a controlled environment, which is an essential step toward getting research outputs into real-world clinical settings for patient benefit.

Status Active Start date January 2006 Childsmile is a national health improvement programme focused on reducing oral health inequalities among children in Scotland Overview The three main components of Childsmile are Toothbrushing, Fluoride Varnish, and Community and Practice, which together deliver education and support to children in nurseries and schools, embed support workers into the community and provide early intervention in preventive care for children aged two and above to improve the oral health of children in Scotland. 1. Toothbrushing: Distributing multiple packs to children and supporting daily supervised toothbrushing in nurseries and schools 2. Community and practice: Addressing oral health inequalities through embedding support workers in communities to offer oral health support 3. Fluoride varnish: Delivering preventative care interventions for children aged two years and upstairs to children who are at increased risk of dental decay HIC's role Health Informatics Centre (HIC), University of Dundee, developed invaluable data collection software and continues to support and update this data. The software consists of an NHS administration website providing functionality such as user and establishment management, diary/event creation, dental contact and validation, data query validation, and data reporting at local and national level. The system currently has over 450 active users across Scotland with over 300 unique users logging in monthly. Impact - The 2020 Childsmile programme results show a decline in tooth decay amongst 5-year-olds, with only 26% experiencing decay. While decay rates remain higher in deprived children, they also dropped significantly from 79% to 55% (2007-2020). - Data from the Childsmile software informs local and national improvements, embedded trials, intervention effectiveness studies, and has contributed to over 30 research papers through data linkage. - The Childsmile Programme has significantly improved children's oral health in Scotland, influencing research and driving policy changes at government level. - Childsmile's preventative, community-based approach has transformed dental care for Scottish children from birth to age 12, benefiting around 730,000 annually since 2007. - Childsmile was officially added to the primary care dental contract in 2011, and in 2012 was included in Scotland's universal child health surveillance programme.

Cultural efficacy (Author, forthcoming, (a) & (b)) suggests internalized cultural values in conjunction with cultural identity work to (1) restrain individuals from deviant behavior while (2) motivating each to respond to community deviance. In this theoretical discussion of cultural efficacy within a Native American Indian tribal community, the theory of collective efficacy (Sampson, Roaenbush & Earls, 1997) is analyzed. The author argues cultural efficacy is a more robust construct to use in tribal communities to better understand community-level dynamics that might intercede in the prevention (or amelioration) of criminogenic community circumstances. A variety of statistical analyses and cultural interpretive techniques are used to support this idea. Directions for future research using cultural efficacy as a construct are provided.

ZusammenfassungC-Peptid, ein Molekül, welches in äquimolarer Konzentration zu Insulin produziert wird, hat sich als Biomarker für die Insulinsekretion bei Menschen mit Typ-1-Diabetes etabliert. Die Messung des C-Peptidspiegels kann in der klinischen Praxis hilfreich sein, um die Restfunktion der insulinproduzierenden β-Zellen zu beurteilen, insbesondere bei Menschen unter Insulintherapie. Sinkende C-Peptidwerte spiegeln dabei eine Verschlechterung der β-Zellfunktion wider. Während die C-Peptid-Sekretion in den ersten Monaten nach Diagnosestellung des Typ-1-Diabetes ein zuverlässiger Prädiktor für eine klinische Teilremission sein kann, gibt es zunehmend Hinweise auf eine persistierende β-Zellfunktion bei Menschen mit langjährigem Typ-1-Diabetes. Bei der Mehrzahl der Menschen mit langjährigem Typ-1-Diabetes ist C-Peptid auch in geringen Mengen nachweisbar, insbesondere wenn hochempfindliche Assays verwendet werden. Trotz erheblicher Fortschritte in der Insulintherapie erreichen in Deutschland nur etwa 44% der Menschen mit Typ-1-Diabetes eine ausreichende Glukoseeinstellung, um Langzeitkomplikationen zu vermeiden. Die Verbesserung der Überlebensrate der verbleibenden β-Zellen, gemessen an der erhaltenen C-Peptid-Konzentration, steht im Mittelpunkt vieler krankheitsmodifizierender Studien. Eine krankheitsmodifizierende Therapie zur Erhaltung der β-Zellfunktion könnte eine alternative oder ergänzende Behandlungsoption zur Insulintherapie bei Typ-1-Diabetes darstellen. Ziel dieser Übersichtsarbeit ist es, die Bedeutung des C-Peptids und seine Rolle bei der Diagnose, Überwachung und Behandlung des Typ-1-Diabetes darzustellen.

Abstract BackgroundALZ‐101 is a vaccine comprised of stabilised oligomeric Aβ42 that stimulates a humoral immune response primarily targeting a toxic, low‐abundant oligomeric form of Aβ. Part A of a clinical Phase 1b trial (ALZ‐C‐001; NCT05328115) was recently concluded with the objectives to assess the safety, tolerability and immunogenicity of ALZ‐101 in subjects with mild AD or MCI due to AD.MethodsParticipants were randomised to receive placebo (n = 6), 125 µg (n = 10) or 250 µg (n = 10) doses of ALZ‐101 at weeks 0, 4, 8, and 16. Primary endpoint safety parameters, including brain MRI scans, were assessed at baseline and before each injection with a follow‐up assessment at week 30. Secondary endpoints included immunogenicity assessments for which blood samples were collected throughout the study. Exploratory endpoints included measuring CSF levels of Aβ, tau, NFL, neurogranin, and inflammation biomarkers for which samples were collected at weeks 0 and 20. Part A of the study includes all data up to week 30; brain MRI was not carried out on all participants at this time point.Results26 eligible participants were dosed in the randomised, double‐blind, placebo‐controlled Part A of study ALZ‐C‐001. The average MMSE and CDR‐SB scores at baseline were 23.9±0.6 and 2.9±1.1, respectively.The study met its primary and secondary endpoints. The vaccine was well tolerated. There were no cases of suspected meningoencephalitis or ARIA‐E. One participant had an MRI finding suggestive of an increase in size of a pre‐existing microhaemorrhage.The vaccine proved immunogenic with oligomer‐specific antibody titres evolving after three administrations. Th2 activity was confirmed by antigen‐recall assays on PBMCs using ELISpot. Higher antibody titres at week 20 correlated with decreases in several CSF biomarkers of AD (p‐tau181, total tau, and neurogranin), but no such associations were observed for neuroinflammation markers (YKL‐40 and sTREM‐2).ConclusionThe results suggest that ALZ‐101 vaccination is safe and generates an Aβ oligomer‐specific humoral immune response that has an impact on several biomarkers associated with disease progression. Taken together, these findings support further development of ALZ‐101 as a potential novel disease‐modifying treatment for patients with AD.

Animals have evolved to rapidly detect and recognize brief and intermittent encounters with odor packages, exhibiting recognition capabilities within milliseconds. Artificial olfaction has faced challenges in achieving comparable results-existing solutions are either slow; or bulky, expensive, and power-intensive-limiting applicability in real-world scenarios for mobile robotics. Here, we introduce a miniaturized high-speed electronic nose, characterized by high-bandwidth sensor readouts, tightly controlled sensing parameters, and powerful algorithms. The system is evaluated on a high-fidelity odor delivery benchmark. We showcase successful classification of tens-of-millisecond odor pulses and demonstrate temporal pattern encoding of stimuli switching with up to 60 hertz. Those timescales are unprecedented in miniaturized low-power settings and demonstrably exceed the performance observed in mice. It is now possible to match the temporal resolution of animal olfaction in robotic systems. This will allow for addressing challenges in environmental and industrial monitoring, security, neuroscience, and beyond.