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Reviews on Recent Clinical Trials - Online First

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28 results

21 - 28 of 28 results

    • Sexual Dysfunctions in Chronic Liver Diseases: A Narrative Review on Prevalence and Putative Pathophysiologic Mechanisms

      https://doi.org/10.2174/0115748871355207250411202640
      Available online: 24 April 2025
      Introduction/Objectives

      Chronic liver diseases have been reported to be associated with altered sexual function. The existing gap in understanding the pathophysiological mechanisms linking sexual disorders and chronic liver diseases may explain the lack of attention given to sexual health in this cohort of patients. We, therefore, aimed at reviewing the available evidence linking chronic liver diseases and sexual dysfunction in both sexes.

      Methods

      A search of the PubMed database was conducted for the period between January 1995 and July 2024 using the following terms: “chronic liver disease”, “liver cirrhosis”, “viral hepatitis B”, “viral hepatitis C”, “non-alcoholic fatty liver disease”, “metabolic dysfunction associated steatotic liver disease” “alcoholic liver disease” and “erectile dysfunction,” “hypogonadism”, “infertility”.

      Results

      A total of 96 articles were reviewed, including preclinical original research articles, human observational and clinical studies, systematic reviews, and meta-analyses. We found that sexual dysfunctions are often associated with chronic liver diseases and that this depends on the degree of the underlying liver damage and etiology. Contributing factors may include hormonal imbalances, psychological disturbances, and endothelial dysfunction.

      Discussion

      The degree of liver function impairment, the specific etiology, particularly metabolic dysfunction associated steatotic liver disease, and drugs used in the management of chronic liver diseases all contribute to sexual dysfunction in this clinical setting.

      Conclusions

      Chronic liver diseases are associated with a wide range of sexual dysfunctions in both sexes, causing an altered quality of life. This suggests that sexual function should be assessed in this clinical setting in order to reach a prompt diagnosis and start appropriate treatment.

    • Cybersecurity and Compliance in Clinical Trials: The Role of Artificial Intelligence in Secure Healthcare Management

      https://doi.org/10.2174/0115748871366467250413070850
      Available online: 24 April 2025

      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 real-time monitoring devices. This study reviews how AI might strengthen cybersecurity procedures in clinical trial setups. Data breaches and unauthorized access are significantly reduced when AI-driven 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.

    • Immune Checkpoint Inhibitors Impact Fertility: A Review

      https://doi.org/10.2174/0115748871340496250130054721
      Available online: 04 February 2025

      Immune checkpoint inhibitor therapy has become the established method of treatment for various types of cancers, consequently introducing a spectrum of side effects referred to as immune-mediated adverse events, affecting almost every organ, including the reproductive system. Moreover, very little clinical data is available that suggests the detrimental effect of immune checkpoint inhibitor therapy on fertility, sexual health, or potential pregnancies. In this manuscript, we reviewed the impact of immunotherapy on male and female fertility and its effect on sexual health. Patients undergoing systemic treatment with immunotherapy often experience sexual dysfunction, decreased sexual drive, erectile dysfunction, and a decline in vaginal lubrication. Fertility-desiring patients who do not receive adequate counseling may ultimately face a higher likelihood of developing anxiety, depression, and a decreased quality of life post-treatment. Therefore, it is crucial to address the reproductive consequences of planned treatment, disseminate knowledge about novel treatments and preventive measures for reproductive side effects, and provide guidance on fertility preservation. Individuals experiencing secondary reproductive dysfunction due to the tumor or its treatment should receive proactive treatment for the underlying condition and be offered hormone replacement therapy.

    • The Effect of Foot Reflexology on the Sexual Function of Lactating Women: A Randomized Clinical Trial

      https://doi.org/10.2174/0115748871345481250128073509
      Available online: 04 February 2025
      Background

      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 ( <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.

      Clinical Trial Registration Number

      IRCT20210814052180N1.

    • From Paper to Digital: Evaluating Electronic Medical Records and their Compliance with EMA Guidelines in European Clinical Trials

      https://doi.org/10.2174/0115748871363256250117172437
      Available online: 27 January 2025
      Background

      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.

      Methods

      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.

      Results

      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.

      Conclusion

      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.

    • New Research on Biomarkers in Alzheimer’s Continuum

      https://doi.org/10.2174/0115748871331138250114052615
      Available online: 24 January 2025

      Alzheimer’s disease (AD) is a multifactorial pathology, responsible for neurodegenerative disorders which in more than 60% of patients evolve into dementia. Comprehension of the molecular mechanisms underlying the pathology and the development of reliable diagnostic methods have made new and more effective therapies possible. In recent years, in addition to the classic anticholinesterases (AChEs), which can control the clinical symptoms of the disease, compounds able to reduce deposits of amyloid-β (Aβ) and/or tau (τ) protein aggregates, which are disease-modifying therapeutics (DMTs), have been studied. The results have shown that symptomatic therapy works best when administered in the disease's mild to moderate clinical phase. On the other hand, treatment with DMTs has been found to be more effective in the preclinical stage of AD, when Aβ and τ protein neurofibrillary tangles have not yet been compromised and patients still have a normal quality of life. This innovative approach requires the identification of specific biomarkers predictive of the disease, detectable many years before clinical signs are evident. Biomarkers allow early diagnosis, give indications of the possible development of dementia in the future, and make it possible to study the evolution of the disease. New scenarios, involving different pathways and approaches, could emerge and provide effective therapies to treat the very early stages of the disease and hamper its progression. The specific biomarkers studied so far have been reported here.

    • Blockchain as a Prime Guardian: Securing Clinical Trial Data Integrity

      https://doi.org/10.2174/0115748871357146250116113310
      Available online: 23 January 2025

      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.

    • Navigating Dry Eye Research: A Comprehensive Review of Etiology, Clinical Trials, Patents, and Recent Advancements

      Authors: Vindhya Pal and Sushma Verma
      https://doi.org/10.2174/0115748871310261240929163138
      Available online: 09 October 2024
      Background

      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.

      Objective

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

      Results

      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.

      Conclusion

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

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