Reviews on recent clinical trials最新文献

Background: Gallstone Disease (GSD) is a multifactorial risk factor for various complications.

Objective: This study aimed to examine the relationship between GSD and Cardiovascular Disease (CVD) through a systematic review and meta-analysis approach.

Methods: A thorough search was conducted across Web of Science, Scopus, MEDLINE/PubMed, Cochrane Library, and Embase databases. Only studies published between 1980 and December 2023 were included. Chi-square, I2, and forest plots were used to assess heterogeneity. Begg's and Egger's tests were used to evaluate publication bias. Statistical significance was considered at p <0.05, and all analyses were performed using Stata 17.

Results: This meta-analysis involved 21 studies and comprised 2,138,282 participants; there has been a significant association found between GSD and an increased risk of CVD (with a relative risk of 1.46, 95% confidence interval: 1.32-1.63, p <0.001). The analysis found no evidence of publication bias based on Begg's test (p =0.085) and Egger's test (p =0.231). Subgroup analysis of the studies showed a higher risk of CVD in studies with a sample size of less than 10,000 participants, conducted in 2016 or later, utilizing a cross-sectional design, in Asian countries; the analysis had a moderate quality score, with a follow-up period of equal to or less than ten years.

Conclusion: There has been a significant association found between GSD and CVD and their incidence is related to each other. Taking proactive steps to implement targeted interventions for individuals with gallstone disease could potentially reduce the risk of cardiovascular disease within this population.

The present study focuses on the possible use of the emerging technology of blockchain in ensuring data management security in clinical trials. With the determination of the chief researchers and clinical investigations becoming more and more complex and international, achieving data quality and integrity, transparency, and legal compliance becomes imperative. By offering a distributed and immutable time-stamped ledger, issues of data revisions, selective data release, and the usually time-consuming issue of compliance auditing are well addressed. With this technology, it is possible to conduct surveillance of multi-center studies without compromising the confidentiality of patients while allowing the researchers to have unbiased information. When it comes to internal accountability, the use of the blockchain will create a situation whereby no alteration of the documents will take place. Thus, regulatory oversight is improved with the engagement of these parties. In addition, it makes sure that the need for bias in the reporting of outcomes is avoided in all trials and all results reported whether positive or negative. In order to address clinical trial data management and clinical trial outcomes' validity and reliability, this review provides reputation management through digital ledger technology in the real world.

Introduction: Non-profit clinical trials submitted for authorization over three years to the Clinical Trials Office of the Italian Medicines Agency were reviewed and critically analyzed.

Objective: The objectives are to highlight potential trends following the full implementation of Regulation (EU) No. 536/2014 and to reveal the different nuances of non-profit clinical trials, comparing them with the general profile of all clinical trials.

Methods: Using a multidisciplinary approach, the research navigates public data, official documents and data retrieved from the Italian National Observatory on Clinical Trials and from the European Clinical Trials Information System to reveal shifts in the clinical trials landscape.

Results: A decrease in non-profit applications submitted in the 2020-2022 timeframe is emerging, clearly related to the new regulatory complexities and uncertainties in the adoption of the Clinical Trials Information System platform. Results also show a divergence between nonprofit and overall clinical trials in terms of authorization outcomes, also including studies with a COVID-19 indication. Further comparing non-profit studies with the total number of clinical trials across different characteristics, such as phases, therapeutic areas and study purposes, increases transparency and availability of insight information.

Conclusion: Relevant data are provided as a result of the review and analysis of non-profit clinical trials, highlighting specific features. Overall, this critical analysis provides an overview of recent trends and, also promotes insights for further consideration by regulators to adequately support clinical research in a complex and evolving regulatory environment.

This comprehensive review explores the multifaceted landscape of preclinical drug development, encompassing crucial stages, regulatory intricacies, Investigational New Drug (IND) submissions, and innovative formulation strategies. Delving into preclinical studies, the review underscores the importance of pharmacokinetics, pharmacodynamics, and safety assessments in animal models. Regulatory requirements governing preclinical studies are dissected, emphasizing compliance with global health authorities. The article provides a detailed examination of the IND submission process, elucidating essential components and documentation required for regulatory approval that are pivotal for advancing to clinical trials. Additionally, the evolving realm of Preformulation strategies is scrutinized, highlighting new methods like nanotechnology, solid dispersions, and formulas based on cyclodextrin to enhance drug solubility, stability, and bioavailability. This comprehensive overview aims to guide researchers, pharmaceutical professionals, and regulatory specialists through the complexities of preclinical development, offering insights into the latest formulation advancements from a legal point of view, making it be easy for potential drugs to go from lab to patient's bedside.

Rapid healthcare digitization has created both previously unheard-of potential and serious data management weaknesses, especially in clinical trials. Artificial Intelligence (AI) offers innovative approaches to enhancing cybersecurity and ensuring legal compliance in healthcare systems. Protecting private information from internet threats is more crucial than ever because clinical trials are increasingly reliant on patient data, electronic health records, and realtime monitoring devices. This study reviews how AI might strengthen cybersecurity procedures in clinical trial setups. Data breaches and unauthorized access are significantly reduced when AIdriven technologies are used for real-time threat detection and response. These systems create a dynamic defense mechanism that traditional security measures lack by continuously adapting to changing cyber threats using machine learning algorithms. In addition to cybersecurity, AI improves adherence to healthcare laws like GDPR and HIPAA by automating data processing procedures. AI protects patient confidentiality and data integrity by ensuring that clinical trials follow stringent regulatory criteria through intelligent automation. Additionally, AI helps detect and control compliance issues, relieving human monitoring and boosting productivity. Additionally, the study addresses the difficulties in applying AI in clinical trials, including the requirement for transparent algorithms and the possibility of bias in AI judgment. However, AI has the capacity to completely transform safe healthcare administration with the correct legislation and ethical guidelines. In conclusion, artificial intelligence (AI) is a vital tool for guaranteeing the confidentiality and legal compliance of medical data in addition to using it to increase clinical trial efficiency. The use of it offers a path forward in terms of the complexities of modern clinical trial cybersecurity. AI's automation and intelligence will lower risk and increase trial speed and accuracy by assisting clinical trial administrators and sponsors in navigating the complicated world of cybersecurity and compliance.

Background: Microbial imbalance is thought to play a role in the pathogenesis of Diverticular Disease (DD).

Objective: We aimed to assess the efficacy of a symbiotic mixture (Prolactis GG Plus®) in the treatment of moderate to severe DD, scored according to the Diverticular Inflammation and Complication Assessment (DICA) classification.

Methods: A retrospective study was conducted enrolling the following patients: at the first diagnosis of DD; in whom DD was diagnosed with colonoscopy and scored according to DICA classification; treated with Prolactis GG Plus® two times/daily for 2 consecutive months; in whom the severity of the abdominal pain was scored with a 10-points visual-analogue scale (VAS) at baseline and the end of follow-up; in whom fecal calprotectin (FC) was assessed at baseline and the end of follow-up as μg/g.

Results: Twenty-four patients were identified (10 males, 14 females; 16 as DICA 2, and 8 as DICA 3). Prolactis GG Plus® decreased the severity of abdominal pain both in DICA 2 (p =0.02) and DICA 3 patients (p =0.01), while FC decreased significantly in DICA 2 (p <0.02) but not in DICA 3 (p =0.123) patients. Acute diverticulitis occurred during the follow-up in two DICA 3 patients but none DICA 2 patients. Add-on therapy was required by eight DICA 2 (50%) and six DICA 3 patients (75%).

Conclusion: In newly diagnosed patients with DD, the symbiotic mixture Prolactis GG Plus® can be a potential treatment for moderate (DICA 2) DD as a single treatment.

Background: Anastomotic leakages are one of the most frequent complications of gastroesophageal surgery with a high mortality.

Objective: This study aimed to assess the efficacy and safety of endoscopic therapy using fully covered self-expanding metal stents (FC-SEMS) for the management of anastomotic leaks.

Methods: In this cohort study, all patients with leak after oncological gastroesophageal surgery treated with FC-SEMS were included. Procedures were performed by one expert endoscopist in three Italian endoscopic units. The primary outcome was clinical success defined as complete resolution of clinical and laboratory manifestations of sepsis with radiological evidence of leak closure. Secondary outcomes were technical success, stent-related adverse events (AEs), and mortality.

Results: 28 patients (21.4% female, mean age 64.3 years) were included in the study, of whom 17 (60.7%) had undergone total gastrectomy, 9 (32.1%) Ivor-Lewis procedure, and 2 (7.1%) extended gastrectomy (transhiatal-abdominal approach). The leaks were located in esophagogastric anastomosis in 5 patients (17.9%), esophagojejunal anastomosis in 19 (67.9%), and esophagus in 4 (14.3%). A total of 34 stents were placed (mean of 1.2 per patient). Technical success of stent placement was achieved in all cases (100%). Clinical success was observed in 78.6% of patients. Stent-related early AEs occurred in 9 patients (32.1%, all were migration). Late AEs occurred in 21.4%, which all were treated endoscopically.

Conclusion: Stenting therapy using FC-SEMS is a safe and effective modality for the management of anastomotic leaks.

Introduction: Sexual health is an essential part of women's lives at different ages. Pregnancy, childbirth, and breastfeeding can affect women's sexual function by inducing biological, psychological, and social changes. Due to the prevalence of sexual dysfunction in lactating women and the effects of reflexology therapies on it, this study was conducted to investigate the effect of foot reflexology on the sexual function of lactating women.

Materials and methods: This randomized clinical trial was conducted in selected health centers of Isfahan in 2022 on 64 lactating women (32 women in each group of intervention and control). The samples were selected using the convenience sampling method and were randomly divided into two groups with a random number table. Each participant in the intervention group received 10 sessions of foot reflexology, and each session lasted for 50 minutes (25 minutes for each foot) and was held every three days. The Female Sexual Function Index (FSFI) questionnaire was completed before the intervention and four weeks after the end of it. The control group received routine care and completed the questionnaire before the intervention and 9 weeks later. Data were analyzed using SPSS version 20 and independent/paired t-tests.

Results: Data analysis showed that the subjects of the two groups were homogeneous in demographic and fertility characteristics at the beginning of the study. The total mean score of sexual function in the intervention group was 20.36 ± 4.16 before the intervention and 28.05 ± 2.89 after the intervention. In the control group, this score was 20.51 ± 3.75 before the intervention and 20.54 ± 3.71 nine weeks after it. A comparison of the total mean score of sexual function and dimensions showed a significant difference between the two groups four weeks after the intervention (p 60;0.001). In the intervention group, significant changes were observed in the total mean score of sexual function and its dimensions four weeks after the intervention compared to before the intervention. However, in the control group, there were no significant changes in this score and its dimensions nine weeks later compared to before the intervention.

Conclusion: Based on the results of this study, lactating women in the two groups did not have a desirable sexual function before the intervention. However, foot reflexology in the present study could effectively improve the sexual function of women in the reflexology group. Therefore, it is recommended to employ foot reflexology therapy in health centers to help lactating women restore their sexual function.

Gout, an inflammatory arthritis form, is renowned for its historical association with affluence. This review delves into its pathophysiology, exploring hyperuricemia, urate crystal formation, and the ensuing inflammatory response. The epidemiology of gout is examined, focusing on its rising prevalence and impact on public health. In this study, progress in gout management is discussed, involving pharmacological interventions, dietary changes, and emerging therapies. Genetic predisposition and triggers like alcohol, temperature, and diet are highlighted in this study. Prevention strategies, including serum urate-lowering therapy and lifestyle modifications, aim to reduce recurrent flares and complications. The inflammatory response in acute gout attacks is elucidated, involving immune cells, cytokines, and the NLRP3 inflammasome. Chronic gout manifestations, such as gouty tophus formation, are explored for their destructive impact on surrounding tissues. Recent advancements in gout treatment, including nanotherapies and novel compounds, are discussed, along with promising urate-lowering drugs. Cutting-edge research on zinc ferrite nanoparticles, dimethyl fumarate, and myricetin/nobiletin hybrids addresses oxidative stress and inflammation in gout. Additionally, the potential therapeutic role of methanolic leaf extract of Euphorbia milii and tip-loaded CLC-Soluplus® MAPs is explored as natural and transdermal alternatives for gout management. The review also covers the development status of new urate-lowering drugs, providing insights into promising candidates and their mechanisms. Patents on gout and recent diagnostic advancements using techniques like laser confocal micro Raman spectrometer, FTIR, and THz-TDS offer a more accurate approach for gout stone analysis, enabling early detection and targeted treatment.

Alzheimer's disease (AD) is a multidimensional, complex condition that affects individuals all over the world. Despite decades of experimental and clinical research that has revealed various processes, many concerns concerning the origin of Alzheimer's disease remain unresolved. Despite the notion that there isn't a complete set of jigsaw pieces, the growing number of public data-sharing initiatives that collect biological, clinical, and lifestyle data from those suffering from Alzheimer's disease has resulted in virtually endless volumes of knowledge about the disorder, far beyond what humans can comprehend. Furthermore, combining Big Data from multi- -omics research gives a chance to investigate the pathophysiological processes underlying the whole biological spectrum of Alzheimer's disease. To improve knowledge on the subject of Alzheimer's disease, Artificial Intelligence (AI) offers a wide variety of approaches for evaluating complex and significant data. The introduction of next-generation sequencing and microarray technologies has resulted in significant growth in genetic data research. When it comes to assessing such complex projects, AI technology beats conventional statistical techniques of data processing. This review focuses on current research and potential challenges for AI in Alzheimer's disease research. This article, in particular, examines how AI may assist healthcare practitioners with patient stratification, estimating an individual's chance of AD conversion, and diagnosing AD using computer-aided diagnostic methodologies. Ultimately, scientists want to develop individualized, efficient medicines.