Reviews on Recent Clinical Trials - Online First

Healthcare data management, especially in the context of clinical trials, has been completely transformed by cloud computing. It makes it easier to store data, collaborate in real time, and perform advanced analytics across international research networks by providing scalable, secure, and affordable solutions. This paper explores how cloud computing is revolutionizing clinical trials, tackling issues including data integration, accessibility, and regulatory compliance.

Key factors assessed include cloud platform-enabled analytical tools, collaborative features, and data storage capacity. To ensure the safe management of sensitive healthcare data, adherence to laws like GDPR and HIPAA was emphasized.

Real-time updates and integration of multicenter trial data were made possible by cloud systems, which also showed notable gains in collaborative workflows and data sharing. High scalability storage options reduced infrastructure expenses while upholding security requirements. Rapid interpretation of complicated datasets was made possible by sophisticated analytical tools driven by machine learning and artificial intelligence, which expedited decision-making. Improved patient recruitment tactics and flexible trial designs are noteworthy examples.

Cloud computing has become essential for international clinical trials because it provides unmatched efficiency in data analysis, communication, and storage. It is a pillar of contemporary healthcare research due to its capacity to guarantee data security and regulatory compliance as well as its creative analytical capabilities. Subsequent research ought to concentrate on further refining cloud solutions to tackle new issues and utilizing their complete capabilities in clinical trial administration.

Pressure injuries (PIs) pose a significant threat to the safety of hospitalized, mobility-compromised patients globally. Olive oil has shown promising results in preventing PIs due to its high concentrations of monounsaturated fatty acids and phenol antioxidants, known for their anti-inflammatory and cell-protective properties. This study aimed to evaluate the effectiveness of topical olive oil combined with routine preventive interventions in reducing PI incidence.

A single-blinded, cluster-randomized study was conducted among 80 hospitalized patients at risk of developing PIs. Participants were randomized into two clusters: the intervention group (IVG, n=40) received standard PI preventive care (skin assessment, repositioning, support surfaces) plus topical olive oil application for 7 consecutive days; the control group (CG, n=40) received only standard care. PI prevalence and Braden Scale scores were assessed at baseline and post-intervention (days 3-8). Data were analyzed using descriptive statistics and paired sample t-tests.

At baseline, both groups had a PI prevalence of 52.5% (n=21). After the intervention, prevalence reduced to 5% (n=2) in IVG and 22.5% (n=9) in CG. The Braden Scale score in the IVG declined from 12.45±0.50 to 11.75±1.13. Statistically significant improvements were observed in Braden scores between day 1 and day 3 (IVG: x̄= -0.28±0.55, t= -3.14, p <0.05; CG: x̄= -0.58±4.69, t= -4.66, p <0.05) and between day 1 and day 8 (IVG: x̄= -0.70±1.07, t= -4.15, p <0.05; CG: x̄= 1.38±1.58, t= -5.50, p <0.05).

The findings underscore the clinical benefit of incorporating topical olive oil into standard PI preventive care. The significant reduction in PI prevalence and improved Braden Scale scores suggest olive oil’s potential role as a protective agent due to its anti-inflammatory and antioxidant properties. These results align with existing literature on natural oil-based interventions for skin integrity. However, limitations include the small sample size and short duration, warranting further large-scale studies.

Topical olive oil, when used alongside standard care practices, significantly reduced the incidence of pressure injuries in hospitalized, at risk patients. This approach could serve as a cost-effective, natural adjunct to PI prevention protocols, particularly in resource-limited healthcare settings.

Colonoscopy is a critical tool for the management of Ulcerative Colitis (UC). In this study, we aim to explore the accuracy of Virtual Chromoendoscopy (VCE) using Narrow Banding Imaging (NBI), and magnification using Near Focus (NF) for a better definition of endoscopic inflammation grade in UC patients compared to standard white light (WL) endoscopy alone.

This is a non-randomized prospective study including all the patients who underwent a colonoscopy (for any reason) between April and September 2023 (with protocol number n. 60/2019.20). During the endoscopic evaluation, at least one image with white light - evaluated using the Mayo Endoscopic Score (MES), one image with NBI, one image with NBI plus NF, and a biopsy were obtained in each colonic tract (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum). All the stored images were evaluated by three endoscopists separately and compared with the results of the histological evaluation.

A total of 31 UC patients were included. The inter-rater reliability concerning the different scores used (MES, NBI score, and NBI plus NF score), which was evaluated with Cohen's kappa coefficient, was good for the MES, good to excellent for the NBI score, and good for the NBI plus NF score. The concordance between histological evaluation (using the Nancy Index) and the MES was unsatisfactory for all the endoscopists, while the concordance between the NBI evaluation score and the Nancy Index was good to excellent.

The reported results demonstrated both the inter-rater reliability and diagnostic accuracy of NBI in assessing endoscopic disease activity. The high inter-operator agreement, ranging from good to excellent, further supports the feasibility and consistency of NBI as a practical tool.

The results in the present study suggest that the new endoscopic technologies could be useful to better define disease activity in Inflammatory Bowel Disease (IBD) patients driving better therapeutic strategy.

Clinical trial regulations are essential for ensuring the safety, efficacy, and ethical conduct of drug development. However, the regulatory frameworks governing these trials vary significantly across different countries, affecting approval processes, trial conduct, and drug development timelines. By comparing clinical trial regulations and trial management practices, this study aims to identify regulatory challenges and propose improvements to enhance global harmonization.

This review examines clinical trial regulations across the United States, European Union, Australia, and India, selected based on their diverse regulatory frameworks and global influence on clinical research. Literature screening was conducted using PubMed, Scopus, and official regulatory agency websites, focusing on publications from 2016 to 2024. Selection criteria included regulatory frameworks, amendments, ethical guidelines, and compliance measures related to clinical trials. The analysis covered key aspects such as trial approval timelines, safety reporting requirements, cost implications, and oversight mechanisms to identify regulatory challenges and potential improvements.

The findings reveal that although the studied countries maintain strict regulatory frameworks, they still exhibit gaps and inconsistencies. For instance, variations in approval timelines, safety reporting standards, and oversight mechanisms create inefficiencies and delays in drug development. It notes the absence of specific regulations for Clinical Research Organizations (CROs) authorization and herbal medicine trials in most regions.

Therefore, a key recommendation is to certify CROs to enhance the credibility of clinical trials. Additionally, specific regulations for herbal medicine trials are required to ensure safety and efficacy. Ethical concerns, particularly in pediatric and orphan drug research, demand more stringent oversight. The integration of blockchain technology is also proposed to improve accountability in drug development. Overall, promoting global regulatory harmonization is essential to minimize delays in patient access to essential therapies. These insights are intended to guide policymakers, researchers, and stakeholders in enhancing the quality, safety, and accessibility of medicines.

This review underscores the importance of consistent, transparent, and adaptable clinical trial regulations across global jurisdictions. While current frameworks demonstrate a commitment to ethical and scientific rigor, targeted reforms, such as CRO recognition, herbal trial regulation, and technology integration, are important for advancing clinical research. A harmonized regulatory landscape not only accelerates drug development but also ensures timely patient access to innovative and life-saving therapies.

Among premenopausal women, polycystic ovarian syndrome (PCOS) is one of the most ubiquitous endocrine and metabolic conditions. Abdominal adiposity, insulin resistance, obesity, metabolic diseases, and cardiovascular hazards are often associated with PCOS. This investigation aims to decipher the influence of oral Vitamin D3 supplementation (2000 IU/day for three months) on glucose metabolism in PCOS women.

123 subjects (females 16 to 40 years of age) were arbitrarily allocated to three cohorts (n = 41 in each cohort) Each participant received two tablets daily and a sachet every month for three months (Group I: Vitamin D3 Tablets + placebo sachets; Group II: Placebo Tablets + Vitamin D3 sachets; Group III: Tablets + Placebo sachets).

Among 123 PCOS subjects, 93.4% exhibited hypovitaminosis D. The baseline 25-hydroxyvitamin D (25(OH)D) concentration of 13.76 (SD ± 10.61) ng/ml increased by 86.84% post-intervention. Groups I and II (active group) depicted substantial diminution in pre-treatment fasting and 2-h blood glucose, with no substantial change in the HOMA-IR. Group III (placebo) showed no improvement in vitamin D status or HOMA-IR. Overall, we observed no substantial HOMA-IR improvement with vitamin D subjunction. However, subgroup analysis revealed a statistically significant enhancement in HOMA-IR for subjects achieving a two-fold upsurge in post-supplementation 25(OH)D levels (≥ 20 ng/ml) compared to those without this increase (p = 0.025).

The cohort’s mean blood 25-hydroxyvitamin D concentrations were successfully boosted by 84% by Vitamin D3 dosage; yet, the influence on insulin resistance markers displayed a subtle complexity. A relationship was found amid the absolute variation in HOMA-IR and the percentage variation in Vitamin D. Nevertheless, there was no substantial general alteration in the mean HOMA-IR across different subgroups.

Vitamin D3 supplementation improves glucose metabolism, as demonstrated by lower fasting and 2-hour blood glucose levels, but overall has no substantial repercussion on measures of insulin sensitivity like HOMA-IR. A larger vitamin D3 dose and an extended follow-up study are essential to comprehend the complex physiology of vitamin D and glucose homeostasis.

Radiotherapy for breast cancer has a clear benefit for long-term survival and local control rate. However, it can negatively impact a patient’s quality of life by affecting healthy surrounding normal tissues, including the heart and lungs. This study aimed to clarify the contribution of echocardiography with Global Longitudinal Strain (GLS) to early radiation-induced cardiotoxicity detection.

A prospective study was conducted on 25 early-stage left-sided breast cancer patients. All underwent 2D strain echocardiography before and one year after RT. Normality was assessed using the Shapiro-Wilk test and box plots. The Wilcoxon signed-rank test was conducted to compare GLS values. A statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 25.

Mean Global Longitudinal Strain value before and one year after radiotherapy was -20.2% and -21.2%, respectively. In half of these cases, the values ranged from -19.65% to -22.70% before radiotherapy and between -18.8% and -22.25% after radiotherapy. The non-parametric Wilcoxon test indicated no statistically significant difference before and after radiotherapy (Ζ = 0.902, p = 0.367).

Although no statistically significant reduction in GLS was observed one year post-radiotherapy, a decrease was noted in patients receiving higher cardiac doses, suggesting potential early subclinical myocardial changes. Strain echocardiography shows promise as a sensitive tool for the early detection of radiation-induced cardiotoxicity, warranting further research with larger cohorts and extended follow-up.

While this small cohort study did not show significant GLS changes post-RT, it highlights the need for larger studies with longer follow-ups to confirm the role of strain imaging in identifying early cardiotoxicity in breast cancer patients.

Significant advancements have been achieved with the use of targeted molecular therapies for the treatment of Soft Tissue Sarcomas (STS). However, data remain scarce about the potential benefits and toxicity of this therapeutic option. In this narrative review, we aim to better clarify the potential wound healing complications in STS patients undergoing neoadjuvant (NA) radiotherapy (RT) combined with targeted therapies.

We used the PubMed database to retrieve journal articles, and the inclusion criteria were all studies that illustrated the potential RT toxicity, combined with targeted therapies, in the NA setting of STS patients.

Our search resulted in seven studies that fulfilled the inclusion criteria. Delayed wound complication rates were observed similarly to RT alone, while one study reported intolerable toxicity without referring specifically to wound complications.

The combination of RT with targeted therapies in STS seems to be effective and well tolerated. Due to the lack of studies with a high level of evidence, further research is required to enhance the existing knowledge for its potential value in this field.