Reviews on Recent Clinical Trials - Volume 20, Issue 3, 2025

Millions of people worldwide suffer from dry eye disease. Dry eye, a multifunctional condition of the ocular surface, typically occurs in conjunction with an unbalanced tear film. With increasing age, the dry eye problem becomes worse. Aqueous-deficit dry eye and evaporative dry eye are the two traditional classifications for dry eye. Various examination tools are used to diagnose dry eye. Clinical trials are conducted in four phases to check the safety and efficacy of drugs. The quick clearance from the precorneal space is ensured by the eye's advanced defense mechanism. It restricts the integrated medicine's entry into the eyes, resulting in a usually low bioavailability for topical eyedrops. In this study, we focus on recently developed formulations for curing dry eye.

This review's goal was to outline the etiology, clinical discovery and development, patents, and recent advancements for dry eye disease.

The current study has described the widespread incidence of dry eye, which was found to be more common as people aged and recently developed formulations are treating dry eyes. According to research, novel formulations are enhancing ocular drug delivery.

In this review, etiology, clinical data, dry eye formulation patents, and recent advancements are all included.

Over the past decade, there has been a significant shift from paper-based to digital medical record management, driven largely by advances in digital technology. This transition has led to widespread adoption of Electronic Medical Records (EMRs), with the expectation that paper documentation will soon be fully replaced. In response, the European Medicines Agency's “Guideline on Computerised Systems in Clinical Trials” outlines essential criteria for validated EMR systems to ensure data integrity and security, and sets standards for electronic source documents in clinical trials.

From December 2023 to March 2024, the Italian Group of Data Managers and Clinical Research Coordinators (GIDMcrc) conducted an online survey across clinical research sites in Italy, France and Belgium to assess the characteristics of medical records and source documents.

The survey was completed by 37 centres: 70.3% from Italy, 16.2% from France and 13.5% from Belgium. Most sites use a mixed paper/electronic Source Document (SD) system (72.3%), with fewer centres having fully electronic SD systems (13.5%) or fully paper-based systems (16.2%). EMR systems are used in 70.3% of sites, but only 23.8% comply with EMA guidelines for computerised systems. A country-specific analysis was also conducted to further explore the situations in Italy and France/Belgium.

Despite the widespread use of Electronic Medical Records (EMRs) in Italy, France and Belgium, Italy lags behind the other two countries in terms of digitization. Despite the presence of an EMR, many centres still use a mixed system of paper and electronic source documents. There is also a lack of awareness regarding EMA and GCP standards, particularly concerning training and system testing. The higher response rate from Italian centres highlights the need for a larger sample in France and Belgium, and a follow-up survey would be beneficial for assessing progress and refining corrective actions.

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

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.

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.

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.

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

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.

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.

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.

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 non-profit 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.

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.

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.

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.

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 <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.

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.

IRCT20210814052180N1.