Reviews on recent clinical trials最新文献

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 (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.

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.

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.

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.

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.

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.

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.

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: In the present study, we evaluated the impact of empagliflozin on serum levels of oxidative stress parameters in individuals with type 2 diabetes (T2DM) who also suffer from heart failure with Reduced Ejection Fraction (HFrEF).

Methods: In this prospective, single-center clinical trial, 80 patients with T2DM and HFrEF, stabilized on guideline-directed heart failure therapy and classified as New York Heart Association functional (NYHA) functional classes II or III, were randomized to receive either empagliflozin (10 mg/daily) or a matching placebo for a duration of 12 weeks. Serum levels of malondialdehyde (MDA), along with the activity of superoxide dismutase (SOD) and glutathione peroxidase (GPx), were measured at baseline and after the 12-week treatment period.

Results: The baseline demographic and clinical characteristics of the randomized patients were comparable across the study groups. As anticipated, empagliflozin demonstrated a significant reduction in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) compared to the placebo after 12 weeks of treatment. Additionally, in comparison to the placebo, empagliflozin significantly increased the antioxidant capacity by elevating serum activity of SOD and GPx, while reducing oxidative damage, as evidenced by diminished MDA levels. Empagliflozin-treated patients also experienced greater improvement in their NYHA functional classes by week 12, though no significant changes in Left Ventricular Ejection Fraction (LVEF) were observed.

Conclusion: The findings of this study shed light on the potential mechanisms through which SGLT2 inhibitors exert their beneficial effects on clinical outcomes in diabetic patients with HFrEF. This provides compelling evidence supporting the cardio-protective of SGLT2 inhibitors in this patient population.

Clinical trial registration number: The trial was registered at the Iranian Registry of Clinical Trials (https://irct.behdasht.gov.ir/trial/72825, identifier code: IRCT20120215009014N484). Registration date: 2022-09-30.

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.

Background: Helicobacter pylori [H. pylori] infection is the main cause of most PUD; therefore, the eradication of H. pylori is extremely important in the treatment of PUD. There are several recommended treatment regimens suggested to eradicate this organism.

Aim: This study compared the efficacy of three anti-Helicobacter pylori regimens in patients with dyspepsia or peptic ulcer disease [PUD].

Objective: The objective of this study was to assess the efficacy of three anti-H Pylori treatments in patients based on C14 urease breath test [C-UBT] results, drug compliance, and adverse effects.

Methods: This randomized, open-label clinical trial included 136 H. Pylori-infected patients without prior treatment. Patients were randomly divided into three groups. The OAC group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and 500 mg Clarithromycin capsules twice a day for 14 days. The OAL group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, and Levofloxacin 500 mg capsules twice a day for 14 days. The OAMB group received 20 mg Omeprazole capsules twice a day, two 500 mg Amoxicillin capsules twice a day, Metronidazole 500mg three times a day, and Bismuth 240 mg twice a day for 14 days. Evaluation for compliance and drug-related adverse effects were assessed at the end of two weeks. H. Pylori eradication was evaluated eight weeks after treatment using the C-UBT.

Results: A total of 136 patients participated in this study, and their groups were matched based on age and sex. The results of the C-UBT test showed that the eradication rate of H. Pylori was 82.2%, 91.3%, and 97.3% for the three-drug OAC, OAMB, and OAL treatment regimens, respectively. Moreover, all the regimens showed high compliance among the patients. Only OAC and OAL showed a significant difference in the H. Pylori eradication rate, and no superiority was found between OAMB and OAL or OAC therapies.

Conclusion: The regime of OAL achieved a satisfactory rate of H. pylori infection eradication with good tolerance in patients with PUD, without any acute side effects.

Clinical trial registration number: IRCT201605189014N100.