Purpose: This study seeks to examine the efficacy of Cape gooseberries ( Physalis peruviana ) in regulating blood glucose levels, contributing to diabetes management. By exploring this cost-effective treatment option, this study could inform public health policies, empower communities to use local resources for managing chronic diseases, and encourage further studies on indigenous foods, ultimately enhancing the understanding of their potential to prevent diseases and promote health. Patients and Methods: A 12-week randomized controlled trial will be conducted with 200 diabetic patients recruited from St. Francis Nsambya and Mulago hospital diabetes clinics. The intervention group will consume 80 grams of fresh gooseberry per day in addition to regular diet and the control group will only consume their regular diet. Fasting blood glucose (FBG) will be assessed at baseline and bi-weekly, while the glycated haemoglobin (HbA1c) levels will be assessed at baseline, 6 weeks and 12 weeks. Adherence will be assessed through food intake diaries, bi-weekly group meetings, and Short Message Service (SMS) reminders. Statistical analysis will be conducted using SPSS. Descriptive statistics will summarize baseline characteristics for both the intervention and control arms. Independent t-tests will compare differences between the intervention and control arms. A p-value of < 0.05 will be considered statistically significant. The primary outcomes are change in the levels of FBG and HbA1c levels. The secondary outcomes are rates of adherence and reported side effects. Discussion: The study is expected to provide evidence that daily consumption of Cape gooseberries improves FBG and HbA1c in patients with T2DM. Positive results could support the integration of indigenous fruit into the dietary recommendations, offering a potentially less expensive strategy for T2DM management and inform future research and public health interventions. Trial Registration Number: The study was registered with The Pan African Clinical Trials Registry (PACTR202503652641300). Keywords: glycated hemoglobin, diabetes, glycemic control, indigenous fruits

Background: Portal hypertension (PH) is a consequence of liver fibrosis and can lead to decompensated cirrhosis with complications such as ascites and gastroesophageal hemorrhage, etc. Liver fibrosis and hepatic architecture disorder contribute to the formation and development of PH. There is an unmet need for curing drugs to improve PH and preventing the occurrence of complications. It is not well known whether anti-liver fibrotic medicines can reduce the risk of PH and decompensated cirrhosis due to HBV, which could be validated by clinical trials. Methods/Design: This is a non-blind, non-placebo-controlled, randomized, multicenter clinical trial. One hundred and ninety-two patients with HBV-related cirrhosis with or without mild gastroesophageal varices in the compensatory stage were enrolled in protocol A. The control group received entecavir (ETV), while the experimental group received Fuzheng Huayu Tablets (FZHY) and ETV. One hundred and eighty-four CHB patients with moderate or severe gastroesophageal varices in the compensatory stage of HBV cirrhosis were enrolled in protocol B. The control group received ETV plus carvedilol (CDL), while the experimental group received FZHY, ETV, and CDL. Both protocols were carried out with 96 weeks of treatment and 12 weeks of follow-up. The primary outcome was the incidence of liver decompensation events in cirrhotic patients. The secondary outcomes included grades of gastroesophageal varices (GEV), liver stiffness measurement, and liver functions. The safety of the testing medicines was also observed. Discussion: Through a multi-center, controlled clinical trial, with the main endpoints of liver decompensated events, we aim to evaluate the clinical efficacy and safety of anti-fibrotic product FZHY on PH in patients with HBV-caused cirrhosis. Trial Registration: Clinical Trials.gov, ID: NCT 02945956/02945982. Registered on Oct 26, 2016. Keywords: portal hypertension, chronic hepatitis B, cirrhosis, decompensation, esophageal varices, Fuzheng Huayu Tablet

Abstract: Effective clinical data management is fundamental to clinical research and regulatory submissions. Modern clinical trials have increasingly adopted web-based electronic data capture (EDC) systems, which enhance data collection efficiency but introduces challenges in data integration and quality. This scoping review explores the transformative role of artificial intelligence and machine learning in evolving CDM into clinical data science. In the review, we followed the PRISMA-ScR guidelines and analyzed the literature from 2008 to 2025 using Scopus, Web of Science, and PubMed databases. A total of 26 papers were included and categorized into those related to clinical data management, natural language processing, and general artificial intelligence/machine learning adoption in clinical data management. The integration shows promise in enhancing data analysis, automating data cleaning, and predicting critical outcomes. The key emerging trends include risk-based quality monitoring, blockchain technology, remote monitoring, and patient-centric approaches involving wearables and mobile applications. The results clearly indicate a substantial increase in data volume in Phase III trials, underscoring the need for advanced technologies natural language processing offers significant potential in interpreting unstructured text data, thereby improving the clinical data management processes. The review concludes on different artificial intelligence/machine learning techniques like natural language processing, predictive analytics, and automation technologies, and their applications in improving data quality and streamlining clinical data workflows. Keywords: clinical data management, artificial intelligence, machine learning, natural language processing, clinical data science, electronic data capture

Aims of Research: Expanding global trial access ensures sustainability by incorporating local contexts and prioritizing patient engagement. This research explores how Organizational Empowerment (OE) and incentive management enhance patient involvement in clinical trials, with Contract Research Organizations (CROs) playing a key role. We propose a paradigm shift based on Grothe-Hammer’s organizational contributorship, where participation replaces formal membership, enabling active decision-making and engagement. Methods: This qualitative research with holistic case study approach explores the role of incentive management in Organizational Empowerment (OE) within Contract Research Organizations (CROs). Through interviews and analysis, it examines the impact of incentive structures on both employees and patients, assessing their effectiveness in aligning organisational goals with patient-centricity principles. Results: A key outcome of the study is the call for a shift in patient roles, proposing that patients transition from non-contributing to contributing members within the organization. The study demonstrates that patient-centered interventions, including logistical and financial support through third-party organizations, can enhance patient retention, engagement, and diversity in clinical trials. These interventions benefit both patients and the organizations by improving trial efficiency and reducing dropout rates. In advancing the field, this research makes a contribution by integrating organizational theory with clinical research management practices, a perspective that has been underexplored. The application of institutional theory to understand regulatory frameworks and their impact on incentive management reveals how external constraints shape organizational behavior. Conclusion: The clinical trial ecosystem relies on collaboration among stakeholders to enhance patient care, requiring a shift toward a patient-centric model for better treatment adherence and outcomes. This study highlights the role of Organizational Empowerment (OE) and incentive management in fostering inclusivity, advocating for contributorship over traditional membership to strengthen stakeholder engagement in clinical research. Keywords: incentive management, organisational empowerment, patient centricity, clinical trials, CRO

Purpose: Anthracycline-induced cardiotoxicity (AIC) is a significant complication in cancer treatment, impacting long-term health outcomes. This study aimed to evaluate interventional clinical trials targeting AIC and identify effective strategies. Methods: We reviewed clinical trials on AIC from International Clinical Trial Registration Platform (ICTRP), focusing on intervention strategies. We assessed the publication status and effectiveness of cardioprotective agents, monitoring techniques, and exercise interventions. Results: A total of 100 trials were identified, with 35% published. Most studies were conducted in the United States, China, and Italy, highlighting geographical disparities. Effective interventions included dexrazoxane for primary prevention, ACEI/ARB combination with β blockers for long-term cardioprotection. Advanced monitoring techniques, including global longitudinal strain (GLS)-guided echocardiography, cardiac magnetic resonance (CMR) and novel biomarkers (cfDNA, microRNA), showed promise in early AIC detection. Exercise interventions demonstrated significant cardiovascular benefits. Conclusion: Cardioprotective agents, early detection methods, and exercise interventions are key to managing AIC. Dexrazoxane and ACEI/ARB combination with β blockers are promising. Exercise interventions can improve cardiovascular health and reduce AIC risk. Larger trials with long-term follow-up are essential for refining these strategies. Keywords: anthracycline-induced cardiotoxicity, clinical trials, cardiovascular toxicity, cancer therapy safety

Purpose: It is crucial to have diverse trial populations to assess the effectiveness of treatments in different patient groups. The purpose of this analysis was to investigate the motivations and barriers to clinical trial participation of potential patients and provide possible solutions to removing these barriers. Patients and Methods: Participants across nine countries, with a variety of ethnic and gender identities, sexual orientations, and socioeconomic backgrounds were included. Potential participants were alerted to the survey via an awareness campaign which included a link to a landing page providing additional information, and the opportunity to sign consent and complete a survey. Survey questions were written to explore how culture, identity, and background influence participant attitudes toward clinical trials. Input into question format was sought from a cross-functional, international team. Results: A total of 3858 participants “true completers” completed all questions in the survey. Of the “true completers” 72.5% of participants said that they would be willing to participate in a clinical trial, but only 23.9% of participants had done so before. The most common barrier to participation was fear of side effects (42.1%) followed by lack of knowledge of clinical trials (23.1%). Financial barriers were also identified, including “potential travel costs” (27.8%) and “a lack of financial compensation apart from travel costs” (24.4%). Survey respondents from minority groups showed a high willingness to participate, with 69.9% of participants who identified as women, 72.7% of LGBTQ+ participants and 96.1% of Black participants expressing an interest in participating in a clinical trial. Conclusion: This survey suggested that insufficient trial enrollment is due to the presence of barriers, rather than an absence of motivation to participate, and should be used to inform new strategies for increasing the diversity of patient populations in clinical trials and making trial participation more widely accessible. Keywords: survey, motivations, socioeconomic, LGBTQ+, gender, race

Nearly 3 years after the emergence of COVID-19, it remains one of the world's problems. COVID-19 vaccination is a priority programme for reducing death and severe symptoms. The primary recombinant novel coronavirus ZF2001 vaccine has gone through Phase III clinical trials and demonstrates efficacy against the highly critical COVID-19 globally and in Indonesia (87.6% and 76.0%, respectively). This study aimed to assess immune persistence after three doses of ZF2001. The study monitored and followed up 400 participants 14 days and 6 months after the third dose and investigated immune persistence 6 months after the phase III vaccination (ZF2001). This study was conducted at recruitment locations in Bandung. Participants were divided into the vaccine and placebo groups and entered into the immunogenicity group. The immune persistence of the vaccine was assessed by measuring geometric mean titres (GMT), neutralising antibodies and seropositivity of IgG anti-S-receptor-binding domain (RBD) after 14 days and 6 months. The seropositive antibody rates were nearly the same between 14 days and 6 months. After 6 months, the GMT, seropositivity of IgG anti-S-RBD and neutralising antibodies in the vaccine group decreased significantly, from 6447.63 to 1514.61 with a P-value of 0.001. A booster was considered important after 6 months.

The aim of this study is to assess the willingness, motivation, satisfaction levels, and expectations of participants engaged in clinical trials, while also exploring factors that influence compliance from the participants' standpoint. Furthermore, this research aims to enhance the understanding of all stakeholders involved in clinical trials about the needs of participants and to offer evidence-based and pragmatic recommendations for effectively managing clinical trial participants. Methods: An electronic questionnaire covers various aspects of Traditional Chinese Medicine (TCM) clinical trials. The distribution of the electronic questionnaire was facilitated through WeChat groups, WeChat Moments, and individual interactions. Count data was expressed in terms of frequency (or rate), and subsequent analysis was conducted utilizing the standard chi-squared test. A p value≤0.05 was considered significant. By drawing a Pareto chart, the priority of factors influencing participants' willingness to participate in clinical trials was systematically assessed. Results: 88 participants answered the questionnaire. A decline in education level corresponded to a decreasing comprehension of participants' grasp of "clinical trial" and "clinical trial participant" (p<0.05). The primary reason for participants' reservations about joining clinical trials stems from their inadequate comprehension of clinical trial details. The key factors contributing to participants' reluctance to engage in clinical trials encompass aspects of trial design, the operational procedures, insufficient understanding of clinical trial particulars, concerns about potential harm to their bodies and opposition from family members. Importantly, these areas of participants' hesitation and unwillingness to partake in clinical trials mirror the factors participants' dissatisfaction contributing to. We found four factors significantly influencing participants' willingness to engage and their overall satisfaction: the participant's profile, trial design, trial institution setup, and the qualifications of the researchers. Derived from these critical factors, this paper presents a series of constructive measures.

The entire clinical trial process is a perfectly orchestrated team. It took many years before centers started hiring clinical trial coordinators. The centers that decided to do so noted not only positive aspects from the technical side of the study, but also from the side of the participants -which are the patients. The aim of the publication was to collect literature data showing the work of the coordinator in the centers and its impact on increasing the effectiveness of the study. The comparison additionally included the importance of the coordinator's role on patient recruitment and perceptions. The centers analyzed, showed the impact of the coordinator on their center's research at approximately: 99.1% in China (knowledge of patient rights), 80% in Italy (increasing the quality of the clinical trial conducted) and 70% in South Korea (impact on reducing patient withdrawal of consent). Those teams that worked without the support of a coordinator gained less trust among patients, which affected recruitment and retention of participants. The coordinator's influence on study management resulted in better organization of the study. Conclusions reached can support the development of centers and thus clinical trials around the world. Hiring a coordinator not only has an impact on improving the management of the study, but also on increasing the number of patients included, and thus increasing the therapeutic options in medicine. This paper aims to compile existing literature concerning the responsibilities of clinical trial coordinators and subsequently advocate for the value they bring to enhancing the efficacy and efficiency of clinical trials.

In the era of expanded access to effective antiretroviral therapy (ART), the life expectancy of the estimated 1.2 million people with HIV (PWH) in the United States has significantly increased. There is a timely need to develop and evaluate interventions for older PWH to improve their health and functioning. The primary objective of the present work was to describe the pilot trial methodology that aimed to evaluate the feasibility and acceptability of a transdiagnostic cognitive behavioral therapy (CBT) intervention for HIV and Symptom Management – “CHAMP” designed to promote healthy aging by way of decreasing psychological distress, health risk behaviors, and inflammation among older PWH. Ultimately, these data will be used to refine the intervention and study methods, and inform a future efficacy trial.