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The article discusses the study "Clinical, Microbiological, and Immunological, Effects of 3- or 7-Day Systemic Antibiotics Adjunctive to Subgingival Instrumentation in Patients with Aggressive (Stage III/IV Grade C) Periodontitis: A Randomized Placebo-Controlled Clinical Trial" by Raluca Cosgarea et al, which won 2023 Clinical Research Award. The award was presented by the American Academy of Periodontology and sponsored by Quintessence Publishing Company. An overview of the study is offered.

In clinical nutrition research, the medical industry chain generates a wealth of multidimensional spatial data across various formats, including text, images, and semi-structured tables. This data's inherent heterogeneity and diversity present significant challenges for processing and mining, which are further compounded by the data's diverse features, which are difficult to extract. To address these challenges, we propose an innovative integration of artificial intelligence (AI) with the medical industry chain data, focusing on constructing semantic knowledge graphs and extracting core features. These knowledge graphs are pivotal for efficiently acquiring insights from the vast and granular big data within the medical industry chain. Our study introduces the Clinical Feature Extraction Knowledge Mapping (CFEKM) model, designed to augment the attributes of medical industry chain knowledge graphs through an entity extraction method grounded in syntactic dependency rules. The CFEKM model is applied to real and large-scale datasets within the medical industry chain, demonstrating robust performance in relation extraction, data complementation, and feature extraction. It achieves superior results to several competitive baseline methods, highlighting its effectiveness in handling medical industry chain data complexities. By representing compact semantic knowledge in a structured knowledge graph, our model identifies knowledge gaps and enhances the decision-making process in clinical nutrition research. [ABSTRACT FROM AUTHOR]

Objective The Italian Association of Preeclampsia (AIPE) and the Italian Society of Perinatal Medicine (SIMP) developed clinical questions on maternal hemodynamics state of the art. Study Design AIPE and SIMP experts were divided in small groups and were invited to propose an overview of the existing literature on specific topics related to the clinical questions proposed, developing, wherever possible, clinical and/or research recommendations based on available evidence, expert opinion, and clinical importance. Draft recommendations with a clinical rationale were submitted to 8th AIPE and SIMP Consensus Expert Panel for consideration and approval, with at least 75% agreement required for individual recommendations to be included in the final version. Results More and more evidence in literature underlines the relationship between maternal and fetal hemodynamics, as well as the relationship between maternal cardiovascular profile and fetal-maternal adverse outcomes such as fetal growth restriction and hypertensive disorders of pregnancy. Experts agreed on proposing a classification of pregnancy hypertension, complications, and cardiovascular states based on three different hemodynamic profiles depending on total peripheral vascular resistance values: hypodynamic (>1,300 dynes·s·cm −5), normo-dynamic, and hyperdynamic (<800 dynes·s·cm −5) circulation. This differentiation implies different therapeutical strategies, based drugs' characteristics, and maternal cardiovascular profile. Finally, the cardiovascular characteristics of the women may be useful for a rational approach to an appropriate follow-up, due to the increased cardiovascular risk later in life. Conclusion Although the evidence might not be conclusive, given the lack of large randomized trials, maternal hemodynamics might have great importance in helping clinicians in understanding the pathophysiology and chose a rational treatment of patients with or at risk for pregnancy complications. Key Points Altered maternal hemodynamics is associated to fetal growth restriction. Altered maternal hemodynamics is associated to complicated hypertensive disorders of pregnancy. Maternal hemodynamics might help choosing a rational treatment during hypertensive disorders. [ABSTRACT FROM AUTHOR]

In multicentric studies, data sharing between institutions might negatively impact patient privacy or data security. An alternative is federated analysis by secure multiparty computation. This pilot study demonstrates an architecture and implementation addressing both technical challenges and legal difficulties in the particularly demanding setting of clinical research on cancer patients within the strict European regulation on patient privacy and data protection: 24 patients from LMU University Hospital in Munich, Germany, and 24 patients from Policlinico Universitario Fondazione Agostino Gemelli, Rome, Italy, were treated for adrenal gland metastasis with typically 40 Gy in 3 or 5 fractions of online-adaptive radiotherapy guided by real-time MR. High local control (21% complete remission, 27% partial remission, 40% stable disease) and low toxicity (73% reporting no toxicity) were observed. Median overall survival was 19 months. Federated analysis was found to improve clinical science through privacy-friendly evaluation of patient data in the European health data space. [ABSTRACT FROM AUTHOR]

With the continuous advancement of medical research, the number of multi-center clinical studies has been steadily increasing, bringing about significant challenges to ethical review. Improving the efficiency and quality of ethical review has become a necessity driven by national policies and the development of the industry. Mutual recognition of ethical reviews is one of the most effective ways to enhance the efficiency of ethical review in multi-center clinical trials. The promotion of mutual recognition of ethical reviews is both feasible and practically significant; however, progress has been less than ideal. Through conducting surveys, this study attempts to understand the status of mutual recognition of ethical reviews in Jiangsu Province, identify the reasons hindering the implementation of mutual recognition, and propose possible solutions. The results indicate that while most medical and health institutions are aware of the policies related to mutual recognition of ethical reviews, the majority remain in a wait-and-see attitude. Ensuring policy guarantees and the high quality and homogeneity of ethical review across institutions are considered necessary conditions for achieving mutual recognition of ethical reviews. [ABSTRACT FROM AUTHOR]

This editorial explores the limitations of artificial intelligence (AI) in cancer clinical research. It discusses the risks of bias in AI models and issues such as inadequate sample size and overfitting in the literature. The article argues that AI lacks the cognitive ability for understanding and meaning, as well as the capacity for insight and discovery that humans possess. It emphasizes the importance of human intelligence, creativity, and ethical considerations in utilizing AI appropriately, and highlights the need for careful scrutiny and cautious application of AI in research and decision-making. [Extracted from the article]

Background: Following acute coronary syndrome (ACS), up to 40% of patients report elevated depressive symptoms which is associated with a two-fold increase in mortality risk due to behavioral and biological mechanisms. Mindfulness-Based Cognitive Therapy (MBCT) delivered via synchronous group videoconferencing could help reduce depressive symptoms. Objective: To guide MBCT adaptation for ACS patients for a future clinical trial, this qualitative study aimed to explore ACS patients' (1) symptoms after ACS, (2) needs for behavioral health treatment, (3) perspectives on mindfulness intervention and group videoconference delivery, and (4) willingness to self-collect dried blood spots in a research study. Methods: We compared ACS patients with and without depressive symptoms to highlight particularly relevant treatment topics for patients developing depression following ACS experience. From 2/2019-11/2019, we conducted semi-structured individual telephone interviews with N = 23 patients after ACS (N = 13 with and N = 10 without elevated depressive symptoms; 63.4 (SD = 8.5) years, 87% male, 96% non-Hispanic white, 7.1 (SD = 7.5) years since ACS). In qualitative content analyses, four independent coders coded each interview. Results: Participants with depressive symptoms experienced emotional, physical, social, and health behavior problems, while those without depressive symptoms made positive health behavior changes and struggled with anxiety symptoms. Both groups were interested in a behavioral health treatment for emotional and social support. Most were willing to participate in a mindfulness group via videoconferencing; some preferred in-person, but accessibility and convenience outweighed these cons. Almost all were willing to self-collect dried blood spots and some were already familiar with this technique. Conclusion: ACS patients, especially those with depressive symptoms, need help managing a multitude of quality of life concerns that can be targeted with an adapted MBCT approach. A videoconference-delivered MBCT approach is of interest. Suggestions for adapting MBCT to target the needs of ACS patients are discussed. [ABSTRACT FROM AUTHOR]

Embedding precision medicine in paediatric oncology shows promise to have a positive impact on how children with cancer will be treated in the future. While there are a number of studies of precision medicine in childhood cancer, there is limited evidence available on the cost of implementing the related testing. This is the first Australian study that systematically measures the cost of using precision medicine in the care of high-risk childhood cancers, through the Zero Childhood Cancer Precision Medicine Programme. In 2021 Australian dollars, the estimated costs inclusive of genomic and preclinical testing were: (A) $12,743 per patient for access; (B) $14,262 per identification of molecular cause; and (C) $21,769 per MTB recommendation. The information gained supports the understanding of the cost of reporting clinically significant outcomes relevant to the biology of the tumour, diagnosis, prognosis and potentially improving clinical management for a child. [ABSTRACT FROM AUTHOR]

Objective: To consider the approaches within Web of Science Core Collection (WoSCC) databases for limiting geographically. To compare the limits to an adaptation of NICE's UK MEDLINE filter for use on WoSCC databases. Methods: We tested and appraised the inbuilt functions and search field options that support identification by countries/regions and affiliations. We compared these with an adapted filter to identify healthcare research on or about the UK. We calculated the recall of the inbuilt limits and filter using 177 studies and investigated why records were missed. We also calculated the percentage reduction of the overall number-needed-to-screen (ONNS). Results: Inbuilt limits within WoSCC enable identification of research from specific countries/regions or affiliations if there is data in the address field. Refining by affiliations allows retrieval of research where affiliations are in the 200 or 500 most frequent for a set of results. An adaptation of the UK MEDLINE filter achieved an average of 97% recall. ONNS was significantly reduced using the filter. However, studies where the countries or regions are only mentioned within the full text or other non-searchable fields will be missed. Conclusion: Information specialists should consider how inbuilt geographic limits operate on WoSCC and whether these are suitable for their research. The adapted filter can sensitively limit to the UK and could be useful for systematic reviews due to its high recall and ability to significantly reduce ONNS. Geographic filters can be feasible to adapt for use on WoSCC databases (where similar search fields are used between platforms). [ABSTRACT FROM AUTHOR]

The article discusses the new ethical guidance for conducting research involving refugee populations, emphasizing the need for special protections akin to those for other vulnerable groups. Topics discussed include the unique trauma and vulnerabilities of refugees, strategies for ensuring informed consent while minimizing harm, and the importance of involving the refugee community in the research process.

In a rapidly changing healthcare environment, we need a robust evidence base to inform effective education and training. This study aimed to examine factors perceived to determine career progression in clinical education research in the UK. Six online focus groups were conducted, with 35 participants from a range of medical, dental, nursing, and allied health professions who identified as aspiring or early career clinical education researchers. Transcripts underwent thematic analysis. Two themes and associated subthemes were constructed to illustrate perceived factors impacting on career development: (1) A cultural challenge from clinical norms. Challenges included differences between the epistemological assumptions of biomedical and clinical research, and the underlying philosophy of education research, which is more closely aligned with the knowledge generation of the social sciences. This led to difficulty communicating the impact of education research to patient care. There were also blurred boundaries between education delivery and research, with the latter lacking a clearly defined group identity. (2) Structures, systems and relationships for career progression. Practical considerations included time and funding (or lack thereof), the opportunity to undertake formal training, networking and role models. This research highlights a number of systemic barriers and facilitators to careers in clinical education research and offers targets of intervention to enable a sustainable academic workforce in clinical education research. [ABSTRACT FROM AUTHOR]

The article focuses on the neuroethical implications of using machine learning-generated clinical data (MLCD) in healthcare, arguing that it should be considered collateral or atypical research rather than traditional clinical research. It discusses the distinct cognitive and epistemic structures of MLCD compared to traditional research; and the necessity for tailored regulatory approaches that consider the disparities between global North and South in the deployment of ML technologies.

Conducting clinical research in public sector community mental health centers (CMHCs) can be challenging. The purpose of this report is to describe the challenges our research team encountered in engaging CMHC providers in a clinical trial aimed at testing an intervention to improve parent activation and engagement in their child's behavioral healthcare. We discuss the intervention we aimed to test, the challenges we encountered engaging providers, and the barriers to engagement that we identified. The barriers included restrictive inclusion criteria, an ambitious randomized controlled design, a dyadic (provider-parent) recruitment plan, a requirement to record provider-parent sessions, and high day-to-day practice demands on providers. The strategies we used to address the barriers and a discussion of the "trade-offs" these strategies introduced are presented. Improving provider engagement in research in CMHCs can avoid research delays or termination of studies and ultimately mitigate an early blockage in the research-to-practice pipeline. [ABSTRACT FROM AUTHOR]

Advancing care in Emergency Medicine (EM) requires the development of well‐trained researchers, but our specialty has lower amounts of research funding compared to similar medical fields. Increasing the number of pathways available for research training supports the growth of new investigators. To address the need for more EM researchers, the Society of Academic Emergency Medicine and the American College of Emergency Physicians convened a Federal Research Funding Workgroup. Here, we report the workgroup recommendations regarding the creation of Research Training Fellowships using the T32 grant structure sponsored by the National Institutes of Health. After reviewing the history of NIH‐grant supported research fellowships in EM, we outline the rationale and describe the core components of T32‐supported research fellowships, including program design, fellow evaluation, and recruitment considerations. [ABSTRACT FROM AUTHOR]

Peter Drucker pointed out an important distinction between ‘doing things right’ and ‘doing the right thing’, which recognised that all problems are embedded in a context and thus can only be understood within their unique contextual setting. Contemporary research practices in clinical medicine often regards contextual factors as potential confounders that will bias effect estimates and thus must be avoided. However rigorous, research devoid of context ultimately deprives users of understanding of the support factors that make research transferable to policy decisions or managing care of individual patients—it stands in the way of ‘doing the right thing’ in ‘real life’ settings. Appreciating that all problems are embedded in a greater context means that one should not ignore their interconnected and interdependent systemic nature, that is, every variable is simultaneously dependent and independent. This is the reason for the cascading effects and feedback loops witnessed in disease progression and policy efforts. We discuss the need for researchers to a‐priori consider the context of their research question as well as the structural relationships of the variables under investigation, which in turn provides the basis for choosing the most appropriate research design. We have a moral imperative to first ‘do the right thing’—ask questions that address the contextual needs of our patients, and then to ‘do it right’—choose the best research method to answer this contextually framed need. Only then will our research efforts have meaningful and lasting impacts on patient care. [ABSTRACT FROM AUTHOR]

Background: Nurses' competence in clinical research is a key element in promoting high quality in the discipline of nursing, and the ethical aspects of research are of paramount importance. Therefore, nurses need to have a comprehensive understanding of the ethics associated with clinical research, which is an integral part of safeguarding the safety of subjects, ensuring the quality of nursing clinical research, and improving the ethical standardization of clinical research. Methods: A cross-sectional survey was conducted on 304 nurses in a province of China between April 2023 and September 2023, utilizing convenience sampling. The survey questionnaire comprised two sections: a general information form and a questionnaire focusing on nurses' knowledge and attitudes towards clinical research ethics. Data analysis encompassed descriptive statistics, t-tests, one-way ANOVA, and multiple linear regression. Results: A total of 320 questionnaires were distributed, of which 304 were valid. The ethical attitude of nurses in clinical research was better (91.17 ± 15.96), while the cognitive score was lower (63.08 ± 12.30). The results of multiple linear regression analysis showed that degree, grade of hospital (I, II or III), technical title, number of clinical projects chaired in one year and whether the respondent has ever participated in an ethics training were the five factors influencing the knowledge of clinical research ethics (F = 9.341, P < 0.001, R2 = 18.0%); degree, grade of hospital (I, II or III), technical title, number of clinical research projects chaired in one year, whether the hospital has an ethics committee and whether the respondent has ever participated in an ethics training were the six factors affecting ethical attitudes towards clinical research (F = 8.919, P < 0.001, R2 = 17.3%). Conclusions: Nurses in a Chinese province scored low on the cognitive dimension of clinical research ethics, but their attitudes were at a relative high level, with many influencing factors. Degree, technical title, and grade of hospital, all affect cognitive and attitude scores. It is also worth noting that whether the hospital has an ethics committee affects the attitude scores, but has no effect on the cognitive scores.Nursing administrators and educators should consider providing effective and targeted strategies (e.g., ongoing training, scholarly seminars, and scholarly exchanges) to enhance nurses' knowledge and competence in clinical research ethics to protect subject rights as well as to ensure the quality of clinical research. [ABSTRACT FROM AUTHOR]

Cytomegalovirus (CMV) infection and disease are important causes of morbidity and mortality in transplant recipients. For the purpose of developing consistent reporting of CMV outcomes in clinical trials, definitions of CMV infection and disease were developed and most recently published in 2017. Since then, there have been major developments, including registration of new antiviral agents. Therefore, the Transplant Associated Virus Infections Forum, which consists of scientists, clinicians, regulators, and industry representatives, has produced an updated version of these definitions that incorporates recent knowledge with the aim of supporting clinical research and drug development. This also includes an update regarding the definition of resistant and refractory CMV infections previously published in 2019. As the field evolves, the need for updates of these definitions is clear, and collaborative efforts among clinicians, scientists, regulators, and industry representatives can provide a platform for this work. [ABSTRACT FROM AUTHOR]

Acute kidney injury (AKI) is a multifactorial syndrome with a high risk of short- and long-term complications as well as increased health care costs. The traditional biomarkers of AKI, serum creatinine and urine output, have important limitations. The discovery of new functional and damage/stress biomarkers has enabled a more precise delineation of the aetiology, pathophysiology, site, mechanisms, and severity of injury. This has allowed earlier diagnosis, better prognostication, and the identification of AKI sub-phenotypes. In this review, we summarize the roles and challenges of these new biomarkers in clinical practice and research. [ABSTRACT FROM AUTHOR]

Purpose Professional organizations have emphasized the growing need for pharmacists to possess advanced research skills; however, there is a scarcity of training programs aimed at nurturing clinician-scientists. This report outlines 3 critical care–focused research programs, each offering a unique approach to training clinician-scientists. Summary Limited resources and formalized programs are available to bridge the gap between the demand for and availability of skilled clinician-scientists. Several programs have stepped forward to share their experiences in establishing and executing training initiatives aimed at cultivating skilled clinician-scientists in the critical care practice space. Conclusion Enhancing the development of clinician-scientists for clinical and translational research is necessary in the critical care clinical pharmacy community. [ABSTRACT FROM AUTHOR]

Imaging technologies are used to observe the morphology and function of various organs in the body and have become indispensable in a multitude of fields, ranging from basic research to clinical medicine. The luminescence technology based on the luciferin–luciferase reaction has been used in many research fields as an imaging technique, enabling quantitative analysis and detection at high sensitivity. Specifically in gene therapy and cell therapy, it has been developed as an in vivo bioimaging technique mainly for small animal models because of its non-invasive and time-sequential analysis. Currently, translational research using this luminescence imaging technology in pigs for clinical applications is ongoing. In this review, we discuss the progress of these technologies and issues for their clinical application, focusing on pigs, by comparing conventional imaging techniques, including fluorescent probes, with luminescence imaging techniques. [ABSTRACT FROM AUTHOR]

There is growing awareness of the significant mental health impacts of the COVID-19 pandemic on many Americans. Less is known about the effects on individuals who were living with mental health conditions prior to the pandemic's onset. In addition, little research has explored how this group is coping positively with the challenges of COVID-19. Understanding the strengths these individuals bring to pandemic demands and disruptions can inform recovery for these individuals in the aftermath of this public health emergency. Using results from a cross-sectional, online survey administered during April and May 2020, we use qualitative methods to examine how individuals with symptoms of depression and anxiety were coping with COVID-19. Participants were recruited from two networks of statewide behavioral health community programs in New Jersey and New York. Data come from 48 participants who reported current symptoms of anxiety assessed by the Generalized Anxiety Disorder-2 Scale and/or depression assessed by the Patient Health Questionnaire-2. These respondents demonstrated resilience in navigating disruptions brought on by COVID-19 and reported a range of healthy coping strategies. We identified three themes characterizing successful coping strategies, including utilizing social support systems, practicing self-care, and adjusting one's mindset to deal with challenging experiences. When designing programs, policies, and clinical approaches to support people with mental health conditions, it is essential to focus on strengths. The coping strategies shared by the individuals in this study demonstrate and build on their resilience. More research is needed to discover the strengths people exhibit to deal with the challenges caused by the COVID-19 pandemic. [ABSTRACT FROM AUTHOR]

Simple Summary: The first Onco Summit: The Latin American (LATAM) Chapter was held from 19–20 May 2023, in Rio de Janeiro, Brazil. This educational initiative aimed to discuss the current challenges in cancer care, both globally and in LATAM, and foster the exchange of best practices to address these challenges. The Summit brought together more than 30 international and regional experts and more than 300 oncology specialists to deliberate on the advancements and barriers in oncology, with a focus on strategies tailored to the specific needs of LATAM. This report provides an overview of the key discussions among cancer specialists at the Summit. The Onco Summit 2023: The Latin American (LATAM) Chapter took place over two days, from 19–20 May 2023, in Brazil. The event aimed to share the latest updates across various oncology disciplines, address critical clinical challenges, and exchange best practices to ensure optimal patient treatment. More than 30 international and regional speakers and more than 300 oncology specialists participated in the Summit. The Summit discussions centered on common challenges and therapeutic advances in cancer care, with a specific focus on the unique obstacles faced in LATAM and examples of adaptable strategies to address these challenges. The Summit also facilitated the establishment of a network of oncologists, hematologists, and scientists in LATAM, enabling collaboration to improve cancer care, both in this region and globally, through drug development and clinical research. This report summarizes the key discussions from the Summit for the global and LATAM oncology community. [ABSTRACT FROM AUTHOR]

Why you should read this article: • To learn about a training programme which develops nurses, midwives and allied healthcare professionals’ research skills • To understand how the training programme was evaluated • To find out the extent to which participants’ confidence in research-related activities increased during the programme. Background: Research forms an important part of clinical practice for nurses, midwives and allied healthcare professionals (NMAHPs). However, it is known there is a lack of confidence in this community in the development and use of research skills. The 4Ps Programme is a bespoke research-training programme that focuses on four areas: place, project, person and plan. Aim: To report an evaluation of the 4Ps Programme that used a survey to record the confidence levels reported by NMAHPs. Discussion: An increase in participants’ confidence was observed across all modules in the 4Ps Programme. This exceeded the standard deviation in the ‘place’ session, demonstrating genuine improvement. It was not possible to demonstrate a significant improvement in all cases. Low response rates affected the quality of the data obtained in the study, which would have benefitted from a more targeted approach to questions and better enabled the tracking of individuals’ improvement over the course of the programme. Conclusion: Participation in bespoke, targeted training related to research could lead to an increase in NMAHPs’ confidence in research-related activities. Efforts need to be made to refine the evaluation approach and improve response rates. Implications for practice: The 4Ps Programme can improve research-related confidence. Improved and further longitudinal evaluation will assess its impact in developing future clinical academics. [ABSTRACT FROM AUTHOR]

This review presents a comprehensive summary and critical evaluation of intention-to-treat analysis, with a particular focus on its application to randomized controlled trials within the field of rehabilitation. Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a methodological review that encompassed electronic and manual search strategies to identify relevant studies. Our selection process involved two independent reviewers who initially screened titles and abstracts and subsequently performed full-text screening based on established eligibility criteria. In addition, we included studies from manual searches that were already cataloged within the first author's personal database. The findings are synthesized through a narrative approach, covering fundamental aspects of intention to treat, including its definition, common misconceptions, advantages, disadvantages, and key recommendations. Notably, the health literature offers a variety of definitions for intention to treat, which can lead to misinterpretations and inappropriate application when analyzing randomized controlled trial results, potentially resulting in misleading findings with significant implications for healthcare decision making. Authors should clearly report the specific intention-to-treat definition used in their analysis, provide details on participant dropouts, and explain upon their approach to managing missing data. Adherence to reporting guidelines, such as the Consolidated Standards of Reporting Trials for randomized controlled trials, is essential to standardize intention-to-treat information, ensuring the delivery of accurate and informative results for healthcare decision making. [ABSTRACT FROM AUTHOR]

The authors comment on the randomized controlled trial (RCT) A Very Early Rehabilitation Trial after stroke (AVERT). A total of 2,104 stroke patients was included in the study wherein early mobilization (EM) intervention was carried out within 24 hours after admission. They note the problems existing in clinical studies related to EM, such as screening of included patients, development of intervention methods, and selection of prognostic indicators.

Introduction: Regulations designed to protect children participating in clinical research often restrict the availability of research data necessary for the development of age-specific therapies and drug dosing. Few data exist on how children experience participation in clinical research, and studies investigating young children undergoing an intensive medical treatment are lacking. Methods: Mixed methods with semi-structured interviews and DISCO-RC questionnaires were used to explore young children's and their parents' experiences in clinical research participation during a kidney transplantation trajectory. Findings: Nine children and their parents were interviewed. Children's median age at kidney transplantation was 4 years (IQR 4,7); age at interview was 7 years (IQR 6,9). Thematic content analysis of interviews revealed that most children were unaware of having participated in a study. Both children and their parents frequently were unaware whether procedures were standard care or research related. The additional burden attributed to study participation varied from not at all to heavy in combination with intensive medical treatment. Positive experiences included kind healthcare professionals, effective distraction techniques, educational aspects, contributing to science and extra check-ups. Most reported negative experiences were conflicting communication, spending much time in the hospital, missing school and suboptimal planning. Venous puncture was stressful for all children, whereas the discomfort of other procedures varied. Conclusion: Pediatric clinical research design should focus on education and fun during research procedures, smart planning, consistent communication, close collaboration between clinical and research team and age appropriate distraction techniques. [ABSTRACT FROM AUTHOR]

Background Diagnostic criteria for mental disorders are subject to change. This is particularly true for schizophrenia, whose diagnostic criteria in the current DSM-5 bear little resemblance to what Kraepelin once named "dementia praecox" and Bleuler termed "the schizophrenias." The present study reports results from a survey of experts on two core topics of schizophrenia: (a) whether subsequent editions of the DSM should once again give the Schneiderian first-rank symptoms (FRS; eg, thought broadcasting) the prominent role they had in the DSM-IV and (b) whether the currently quite narrow definition of hallucinations in the DSM-5 requiring them to be vivid and clear and have the full force and impact of normal perceptions should be broadened to incorporate perceptual-like phenomena that the individual can differentiate from proper perceptions but still perceives as real and externally generated. Hypothesis The aim of the survey was to learn about experts' opinions with no clear hypotheses. Study Design International experts on schizophrenia were recruited via various sources and invited to participate in a short online survey. The final sample comprised 136 experts with a subgroup of 53 experts with verified identity and at least 6 years of clinical and/or research experience. Study Results Slightly more experts voted in favor (49.3%) of returning FRS to the prominent role they had in earlier versions of the DSM than against (34.6%). Approximately four out of five experts agreed that the definition of hallucinations in the DSM should be expanded. According to the results, alongside internal symptoms that are phenomenologically indistinguishable from true perceptions, sensory intrusions that the holder is convinced were inserted from another source (ie, not self-generated) should be included in the definition. Conclusions While a large majority of experts recommend a change in the definition of hallucinations, the experts' opinions on FRS are more mixed. We hope that this article will stimulate future studies targeting the diagnostic relevance of these symptoms and encourage discussion about the definition of core psychotic symptoms and the diagnostic criteria for the upcoming edition of the DSM. [ABSTRACT FROM AUTHOR]

The article discusses the American Association of Critical-Care Nurses' (AACN) "Courage to Soar" theme in September 2024. Topics covered include the consideration of three questions on courage by critical care nurses, and the manifestation of courage in critical care clinical research when investigators are willing to admit lack of knowledge and confront current practices. Also noted is the issue of disregard or acceptance of a long-standing clinical problem by critical care nurses.

Background: Orally administered second-generation gepants are effective for the treatment of migraine. The intranasal administration of the third-generation gepant zavegepant might have additional benefits including a rapid onset of action, but it is not clear yet to which extent this has clinical relevance. Methods: We examined the effect of zavegepant on the relaxations induced by calcitonin gene-related peptide (CGRP) in human isolated middle meningeal arteries. Furthermore, we connected the pharmacodynamics and pharmacokinetics of gepants by combining data from clinical and basic research. Results: We showed that 10 nM zavegepant potently antagonized the functional response to CGRP. We also showed that all gepants are effective at inhibiting functional responses to CGRP at their therapeutic plasma concentrations. Conclusions: The relatively low predicted potency of zavegepant to inhibit CGRP-induced relaxation at therapeutic systemic plasma concentrations may point to the relevance of local delivery to the trigeminovascular system through intranasal administration. This approach may have additional benefits for various groups of patients, including overweight patients. [ABSTRACT FROM AUTHOR]

Engaging in clinical trials in Africa not only enhances researchers' comprehension of local health concerns but also plays a crucial role in tackling global health challenges. In Tanzania, there has been a surge of clinical research for the past 10 years indicating a need to improve ethical and clinical trial regulatory capacity. Several initiatives to address the clinical trial regulatory and ethics challenges have been done. Lessons from such initiatives are important to inform evidence-based decision-making for sustainability. The ASCEND project with the theme of "Moving Tanzania's Clinical Research Ethics and Medicines Regulatory Capacity to the Next Level: Fostering Medicine Quality, Safety and Good Clinical Practice (GCP) on Clinical Trials" was implemented in Tanzania Mainland and Zanzibar from November 2020 to December 2023. A thorough review of the project implementation reports and on deliverables was conducted to identify the lessons learned. Inductive content analysis was used to analyze the information. A total of seven lessons were deduced from the reviewed documents. These include capacity building through training on clinical trials review and approval process, research ethics and GCP inspection which cannot be overlooked; engaging the community in reporting adverse drug events is worth considering; digitalization of electronic systems enhances clinical trial control and creates a dynamic regulatory ecosystem; compliance to requirements for clinical trials conduct is enhanced by training of early and mid-career researchers; networking and broad stakeholders' engagement and participation in ethics and regulations governing clinical trials is a cornerstone for strengthening collaboration between researchers and regulators; the need for electronic systems for monitoring and evaluation of the project is inevitable and the need for adhering to project timelines is crucial for successful implementation of the project. Sustainability is the take-home message from the ASCEND project and should inform stakeholders for future improvement. Continuous investment and advancement in research ethics and regulatory oversight across Africa should be prioritized. [ABSTRACT FROM AUTHOR]

Background: Qingfei Paidu Decoction (QFPDD) has played an important role in the prevention and treatment of COVID-19 infection in China. The present study aims to perform an econometric analysis and visualization of the literature on the treatment of COVID-19 with QFPDD in the Chinese databases and English databases. Methods: Six databases including such as Chinese databases CNKI, VIP, CBM, WANFANG as well as English databases PubMed, Web of Science were searched for publications related to the prevention and treatment of COVID-19 with QFPDD. The institutions, authors, keywords of each publication were cisualized using the software of CiteSpace. Results: A total of 187 literature on the prevention and treatment of novel coronavirus infection with QFPDD were included, of which 145 (77.5%) were in Chinese and 42 (22.5%) were in English. Those publications were written by 926 authors from 383 institutions. There were 78 theoretical studies (41.7%), 63 clinical studies (33.7%), and 46 basic studies (24.6%). The cooperative institutions with the core of "Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences" and "Shanghai University of Chinese Medicine Cross Academy of Science" have been formed, and two core teams with "Wang Yanping" and "Zhang Weidong" have been formed. The keyword analysis showed that the research mainly focuses on pathologic pathogenesis, clinical efficacy, adverse reactions, integrated Chinese and western medicine therapy, network pharmacology research. Conclusion: QFPDD has attracted worldwide attention, mechanism research and clinical research may become a future development trend. Therefore, in-depth basic research and clinical studies with large samples and multi-center cooperation should be carried out to provide high-level evidence-based evidence for the prevention and treatment of COVID-19 with QFPDD. [ABSTRACT FROM AUTHOR]

This perspective article explores the challenges and potential of using speech as a biomarker in clinical settings, particularly when constrained by the small clinical datasets typically available in such contexts. We contend that by integrating insights from speech science and clinical research, we can reduce sample complexity in clinical speech AI models with the potential to decrease timelines to translation. Most existing models are based on high-dimensional feature representations trained with limited sample sizes and often do not leverage insights from speech science and clinical research. This approach can lead to overfitting, where the models perform exceptionally well on training data but fail to generalize to new, unseen data. Additionally, without incorporating theoretical knowledge, these models may lack interpretability and robustness, making them challenging to troubleshoot or improve post-deployment. We propose a framework for organizing health conditions based on their impact on speech and promote the use of speech analytics in diverse clinical contexts beyond cross-sectional classification. For high-stakes clinical use cases, we advocate for a focus on explainable and individually-validated measures and stress the importance of rigorous validation frameworks and ethical considerations for responsible deployment. Bridging the gap between AI research and clinical speech research presents new opportunities for more efficient translation of speech-based AI tools and advancement of scientific discoveries in this interdisciplinary space, particularly if limited to small or retrospective datasets. [ABSTRACT FROM AUTHOR]

This study aims to investigate the potential association between serum levels of cytokines, HSP60, HSP70 and IR (HOMA-IR) in postmenopausal women. We conducted a cross-sectional study involving 381 postmenopausal women, including 94 with a breast cancer diagnosis and 278 without. We analyzed anthropometric and laboratory measurements. Immunoassays were used to measure cytokines (TNF-α, IL-10, and IL-6) as well as heat shock proteins (HSP) 60 and 70 in the serum using the ELISA technique. Women diagnosed with breast cancer showed higher levels of HOMA-IR, IL-6, TNF, and HSP60, and lower levels of IL-10 and HSP70 compared to women without cancer. An association was found between HSP70 and HOMA-IR only in women with breast cancer (β = 0.22, p =.030; without cancer: β = 0.04, p =.404), regardless of age, waist circumference, smoking, and physical activity. No associations were observed between cytokines, HSP60, and HOMA-IR in both groups of women. HSP70 is positively associated with IR in women diagnosed with breast cancer. [ABSTRACT FROM AUTHOR]

Simple Summary: Bone metastases represent a serious and common challenge in advanced cancer patients, making early detection crucial. The growing implementation of artificial intelligence (AI) in various medical fields is revolutionizing healthcare by enhancing diagnostic accuracy. This systematic review includes 59 articles and sought to assess the potential of machine learning models in the fields of nuclear medicine, clinical research, radiology, and molecular biology. The review provides a comprehensive analysis of AI's effectiveness in detecting bone metastases, which had not yet been thoroughly conducted. The findings highlight the benefits of integrating AI technologies in the inspected fields, encouraging further advancements and adoption of AI to ultimately improve patient care and treatment planning. This study provides invaluable perceptions into the promising application of computational intelligence in the detection of bone metastases, demonstrating its superiority over standard tests. However, further research is necessary to substantiate these findings with the aim of developing better-trained data-driven models soon. Background: Metastasis commonly occur in the bone tissue. Artificial intelligence (AI) has become increasingly prevalent in the medical sector as support in decision-making, diagnosis, and treatment processes. The objective of this systematic review was to assess the reliability of AI systems in clinical, radiological, and pathological aspects of bone metastases. Methods: We included studies that evaluated the use of AI applications in patients affected by bone metastases. Two reviewers performed a digital search on 31 December 2023 on PubMed, Scopus, and Cochrane library and extracted authors, AI method, interest area, main modalities used, and main objectives from the included studies. Results: We included 59 studies that analyzed the contribution of computational intelligence in diagnosing or forecasting outcomes in patients with bone metastasis. Six studies were specific for spine metastasis. The study involved nuclear medicine (44.1%), clinical research (28.8%), radiology (20.4%), or molecular biology (6.8%). When a primary tumor was reported, prostate cancer was the most common, followed by lung, breast, and kidney. Conclusions: Appropriately trained AI models may be very useful in merging information to achieve an overall improved diagnostic accuracy and treatment for metastasis in the bone. Nevertheless, there are still concerns with the use of AI systems in medical settings. Ethical considerations and legal issues must be addressed to facilitate the safe and regulated adoption of AI technologies. The limitations of the study comprise a stronger emphasis on early detection rather than tumor management and prognosis as well as a high heterogeneity for type of tumor, AI technology and radiological techniques, pathology, or laboratory samples involved. [ABSTRACT FROM AUTHOR]

Why you should read this article: • To learn how clinical research projects can lead to improved patient outcomes and enhanced staff morale • To understand the importance of engaging clinical managers in research projects • To find out how clinical managers can contribute to the development of a research culture. There is growing evidence that clinical research activity is linked to better patient outcomes and that staff involvement in research is linked to enhanced morale and retention. Clinical managers have a pivotal role in supporting staff to engage with research, but they are not always given the means to do so and are not always aware of the benefits. In 2021 a research internship scheme was set up as a collaboration between two London NHS trusts and a university, enabling nurses and midwives to undergo training and undertake a range of research activities. Some participants experienced challenges in fitting internship activities around clinical duties despite the fact that the scheme was planned to give them protected time. This article describes the scheme, reports the findings of its evaluation at one of the two trusts, and discusses its implications for clinical managers in terms of how they can be supported to contribute to the development of a research culture. [ABSTRACT FROM AUTHOR]

The objective of this study was to examine the impact of methodological changes to the 2018 World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Score on associations with risk for all-cause mortality, cancer mortality, and cancer risk jointly among older adults in the National Institutes of Health (NIH)-AARP Diet and Health Study. Weights were incorporated for each score component; a continuous point scale was developed in place of the score's fully discrete cut points; and cut-point values were changed for physical activity and red meat based on evidence-based recommendations. Exploratory aims also examined the impact of separating components with more than one subcomponent and whether all components were necessary to retain within this population utilizing a penalized scoring approach. Findings suggested weighting the original 2018 WCRF/AICR Score improved its predictive performance in association with all-cause mortality and provided more precise estimates in relation to cancer risk and mortality outcomes. The importance of healthy weight, physical activity, and plant-based foods in relation to cancer and overall mortality risk were highlighted in this population of older adults. Further studies are needed to better understand the consistency and generalizability of these findings across other populations. [ABSTRACT FROM AUTHOR]

Background/Aims: Since the onset of the coronavirus disease 2019 (COVID-19) pandemic, 103.4 million cases and 1.1 million deaths have occurred nationally as of November 2023. Despite the benefit of mitigating measures, the pandemic's effect on participant safety is rarely documented. Methods: This study assessed noncompliance occurring from July 2019 to August 2021 that were stratified by the date of noncompliance (before or after restrictions). Events were described by size, site, noncompliance type, primary category, subcategory, and cause. In addition, noncompliance associated with COVID-19 was analyzed to determine characteristics. Results: In total, 323 noncompliance events occurred across 21,146 participants at risk in 35 protocols. The overall rate of noncompliance increased from 0.008 events per participant to 0.022 events per participant after the COVID-19 restrictions (p < 0.001). For onsite protocols, the median within protocol change in rates was 0.001 (interquartile range = 0.141) after the onset of COVID-19 restrictions (p = 0.54). For large-sized protocols (n ≥ 100), the median within protocol change in rates was also 0.001 (interquartile range = 0.017) after COVID-19 restrictions (p = 0.15). For events related to COVID-19 restrictions, 160/162 (99%) were minor deviations, 161/162 (99%) were procedural noncompliance, and 124/162 (77%) were an incomplete study visit. Conclusion: These noncompliance events have implications for clinical trial methodology because nonadherence to trial design can lead to participant safety concerns and loss of trial data validity. Protocols should be written to better facilitate the capture of all safety and efficacy data. This recommendation should be considered when changes occur to the protocol environment that are outside of the study team's control. [ABSTRACT FROM AUTHOR]

Background/Aims: Information regarding the use of wearable devices in clinical research, including disease areas, intervention techniques, trends in device types, and sample size targets, remains elusive. Therefore, we conducted a comprehensive review of clinical research trends related to wristband wearable devices in research planning and examined their applications in clinical investigations. Methods: As this study identified trends in the adoption of wearable devices during the planning phase of clinical research, including specific disease areas and targeted number of intervention cases, we searched ClinicalTrials.gov—a prominent platform for registering and disseminating clinical research. Since wrist-worn devices represent a large share of the market, we focused on wrist-worn devices and selected the most representative models among them. The main analysis focused on major wearable devices to facilitate data analysis and interpretation, but other wearables were also surveyed for reference. We searched ClinicalTrials.gov with the keywords "ActiGraph,""Apple Watch,""Empatica,""Fitbit,""Garmin," and "wearable devices" to obtain studies published up to 21 August 2022. This initial search yielded 3214 studies. After excluding duplicate National Clinical Trial studies (the overlap was permissible among different device types except for wearable devices), our analysis focused on 2930 studies, including simple, time-series, and type-specific assessments of various variables. Results: Overall, an increasing number of clinical studies have incorporated wearable devices since 2012. While ActiGraph and Fitbit initially dominated this landscape, the use of other devices has steadily increased, constituting approximately 10% of the total after 2015. Observational studies outnumbered intervention studies, with behavioral and device-based interventions being particularly prevalent. Regarding disease types, cancer and cardiovascular diseases accounted for approximately 20% of the total. Notably, 114 studies adopted multiple devices simultaneously within the context of their clinical investigations. Conclusions: Our findings revealed that the utilization of wearable devices for data collection and behavioral interventions in various disease areas has been increasing over time since 2012. The increase in the number of studies over the past 3 years has been particularly significant, suggesting that this trend will continue to accelerate in the future. Devices and their evaluation methods that have undergone thorough validation, confirmed their accuracy, and adhered to established legal regulations will likely assume a pivotal role in evaluations, allowing for remote clinical trials. Moreover, behavioral intervention therapy utilizing apps is becoming more extensive, and we expect to see more examples that will lead to their approval as programmed medical devices in the future. [ABSTRACT FROM AUTHOR]

The aim of the current study is to compare the dosimetry of 3 radiation therapy (RT) techniques used in the EORTC 22922/10925 trial for irradiating the internal mammary (IM) and medial supraclavicular nodes (MS) using a treatment planning system available nowadays for dose calculation. We performed a retrospective dosimetry analysis of anonymised data; thus, ethics approval was not required. Ten cases of left-sided breast were randomly selected for RT planning to a total dose of 50 Gy in 25 fractions. The treatment planning was done according to the trial's protocol and under the supervision of the EORTC trial's coordinators. Doses to planning target volumes (PTV) and to organs at risk (OARs) are reported. Data is presented in descriptive statistics. A total of 10 cases and 40 treatment plans (4 plans per case: standard -plan A, modified standard -plan B, individualised -plan C and breast-only –plan D). For all planning techniques, the mean dose to the PTV of the left breast (plan A-D) and the PTV-MS (plan A-C) exceeded 95% of the prescribed dose (>47.5 Gy). The individualised technique (plan C) had a lower coverage for PTV-IM, with a mean of 87% of the prescribed dose compared to ∼102% for plans A and B. The dose to OARs varied between techniques, with the mean heart dose being higher in the standard and modified standard techniques (18.3 and 16.6 Gy, respectively) compared to the individualised technique (9.5 Gy). The 3 RT techniques used in the trial varied in target coverage and OARs dose. Our results may help to understand the observed larger absolute benefit of individualised IM-MS treatment planning in terms of breast cancer outcomes. • The 3 radiation techniques used in the EORTC 22922/10925 trial to irradiate the internal mammary nodes and medial supraclavicular nodes varied in target coverage and organs at risk dose. • Variation between the 3 techniques were also per patient case. • This dosimetric study shows how radiation planning techniques can lead to significant differences dose coverage, organs at risk dose, and outcomes. • The inhomogeneity and extreme high doses in match line may explain the radiation side effects that match line fibrosis that were often observed in these patients. [ABSTRACT FROM AUTHOR]

In recent years, the potential of Traditional Chinese Medicine in preventing and treating gastric cancer has gained clear recognition. However, there is a lack of comprehensive analysis of the data on the involvement of Traditional Chinese Medicine in the prevention, diagnosis, and treatment of gastric cancer. Therefore, this article aims to organize and analyze relevant information to provide a reference for the use of Traditional Chinese Medicine in the prevention and treatment of gastric cancer. [ABSTRACT FROM AUTHOR]

Background: Treatment of chronic inflammatory bowel disease (IBD) aims to improve patients' quality of life and the extent of treatment success is measured via patient reported outcomes (PROs). However, questionnaires used to collect PROs often include scales that are not specific to IBDs. Improving these scales requires a deeper understanding of patients' lived experience. With this study we give first insights and develop hypotheses on how patients with IBDs experience their body and self and how they adjust their life plans in the context of precision medicine (PM). The guiding question is to understand what they need to achieve a good life, while facing their disease. Methods: We developed a conception of the "good life" that draws on Philippa Foot's "naturalized" approach and distinguishes six different dimensions that are relevant for a good life. This conception guided us as we conducted 10 qualitative interviews with patients suffering from IBD who were in precision medicine clinical research settings. The interviews aimed to gain insights for answering our research question: How do body experiences affect the good life of patients with IBD? We analyzed the interviews with interpretative phenomenological analysis (IPA). Results: Five group experiential themes emerged: (i) Life options and plans, (ii) other people's responses, (iii) strategies to deal with others' responses, (iv) perception of the body and self, and (v) perception of life as good despite suffering. We report here on three of them (i, iv and v), which are primarily relevant for evaluating the outcomes of PM care. Whereas with "life options and plans (i)," our study predominantly confirmed previous research, with "perception of the body and self (iv)," we found that some of the patients changed their relationship to their body and themselves. They perceived the body or the disease as the "other" and their self appears divorced from their own body. Although this might be an avoidance strategy patients use to assign responsibility for their condition and its "disgusting" symptoms to the "other," it is important to include it in patient reported outcome (PRO) assessments. Conclusions: We conclude with the insight that the multi-dimensional approach based on Foot's concept of a good life is well-suited as a basis for investigating the quality of life of people with IBD. Interviews based on this concept produced results that go beyond the understanding of health-related quality of life (HRQoL). Additionally, we offer some considerations about patients' opportunities for achieving a good life and suggestions for further developing patient reported outcome scales. [ABSTRACT FROM AUTHOR]

Simple Summary: The high-level aims of the Advocate-BREAST initiative are to study and improve the overall experience of patients with breast cancer (BC) through education, shared decision making, and patient-centered clinical trials. Advocate-BREAST80+ is a survey substudy that specifically focused on the unique needs and perspectives of BC patients aged ≥80 years. Although patients aged ≥80 years experienced less anxiety and symptom-related distress compared with younger patients, they were significantly less satisfied with information regarding short and long term side effects of BC therapies, as well as the management of same. Older patients were significantly less likely to have participated in a clinical trial or be open to considering this option in future. Future research should address unique educational needs and barriers to research participation in older BC patients. Focused interviews could assist with better comprehension of the lived experience of these patients, given the smaller number of BC patients ≥80 years in many available databases. Background: There are limited evidence-based data to guide treatment recommendations for breast cancer (BC) patients ≥80 years (P80+). Identifying and addressing unmet needs are critical. Aims: Advocate-BREAST80+ compared the needs of P80+ vs. patients < 80 years (P80−). Methods: In 12/2021, a REDCap survey was electronically circulated to 6918 persons enrolled in the Mayo Clinic Breast Disease Registry. The survey asked about concerns and satisfaction with multiple aspects of BC care. Results: Overall, 2437 participants responded (35% response rate); 202 (8.3%) were P80+. P80+ were less likely to undergo local regional and systemic therapies vs. P80− (p < 0.01). Notably, P80+ were significantly less satisfied with information about the short and long-term side effects of BC therapies and managing toxicities. P80+ were also less likely to have participated in a clinical trial (p < 0.001) or to want to do so in the future (p = 0.0001). Conclusions: Although P80+ experienced less anxiety and symptom-related distress compared with P80−, they were significantly less satisfied with information regarding the side effects of BC therapies and their management. P80+ were significantly less likely to have participated in a clinical trial or be open to considering this option. Future studies should address educational needs pertaining to side effects and barriers to research participation in P80+. [ABSTRACT FROM AUTHOR]

The 「Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products」, which took effect on August 28, 2020, was adopted as an alternative to deleting the contents of regenerative medical procedures and leaving only the contents of advanced regenerative medicine clinical research, considering that the government may be mistaken for trying to commercially activate regenerative medicine, which has not been scientifically proven to be safe. However, this act, revised on February 20, 2024, and set to take effect a year later, classifies the risk of advanced regenerative medical treatment and allows it to be conducted in stages. Therefore, about the introduction of the advanced regenerative medical treatment system, we would like to review what has changed in the amendment of the act regarding the designation of advanced regenerative medical implementation institutions, obtaining informed consent for treatment subjects, claiming treatment costs, safety monitoring and reporting adverse reactions, and the role of the institutional bioethics committee. And based on these significant changes, we would like to analyze the problems expected after introducing the advanced regenerative medical treatment system and suggest future improvement measures. [ABSTRACT FROM AUTHOR]

Introduction: The study aimed to pilot test a well-being curriculum for KL2 scholars to be used across the Clinical and Translational Science Award consortium. Methods: Between November 2022, and May 2023, 36 KL2 scholars from 25 hubs participated in the program. The General Well-Being Index for U.S. Workers and the Patient Reported Outcomes Measurement Information System (PROMIS-29) were completed by scholars before and after the program. Results: Postparticipation, there was a trend of improvement in the domains of well-being, sleep, anxiety, and fatigue. Conclusion: Implementing a virtual synchronous well-being curriculum allowed the scholars to connect across the consortium and improve their well-being. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to evaluate the discoverability of supporting research materials, including supporting documents, individual participant data (IPD), and associated publications, in US federally funded COVID-19 clinical study records in ClinicalTrials.gov (CTG). Methods: Study registration records were evaluated for (1) links to supporting documents, including protocols, informed consent forms, and statistical analysis plans; (2) information on how unaffiliated researchers may access IPD and, when applicable, the linking of the IPD record back to the CTG record; and (3) links to associated publications and, when applicable, the linking of the publication record back to the CTG record. Results: 206 CTG study records were included in the analysis. Few records shared supporting documents, with only 4% of records sharing all 3 document types. 27% of records indicated they intended to share IPD, with 45% of these providing sufficient information to request access to the IPD. Only 1 dataset record was located, which linked back to its corresponding CTG record. The majority of CTG records did not have links to publications (61%), and only 21% linked out to at least 1 results publication. All publication records linked back to their corresponding CTG records. Conclusion: With only 4% of records sharing all supporting document types, 12% sufficient information to access IPD, and 21% results publications, improvements can be made to the discoverability of research materials in federally funded, COVID-19 CTG records. Sharing these materials on CTG can increase their discoverability, therefore increasing the validity, transparency, and reusability of clinical research. [ABSTRACT FROM AUTHOR]