Reviews on recent clinical trials最新文献

Background: The HSP90 marker is believed to play a constructive role in facilitating neoplastic transformation mainly via interaction with multiple pro-survival proteins. Welldesigned studies are needed to elucidate the role of HSP90 as a diagnostic marker and therapeutic target in testicular tumors.

Objective: The current study aimed to investigate the expression of HSP90 in various types of testicular cancer and highlight its expression in embryonal testicular cancer.

Material and methods: Immunohistochemical staining for HSP90 in 84 male patients, with nonmetastatic testicular cancer, who underwent orchiectomy from 2000 to 2023, was retrospectively performed at the Laboratory Department of General Hospital of Nikaia in Greece.

Results: A total of 84 males, with a mean age of 36.2 years, who have undergone high-cord radical orchiectomy, were included in this study. Out of the included males, 28.57% had embryonal carcinoma, 23.81% had seminoma, 19.05% had yolk sac tumor, 11.9% had mature teratoma, 9.52% had immature teratoma, and 7.14% had choriocarcinoma. HSP90b was positive in all embryonal carcinoma, seminoma, and choriocarcinoma cases, while it was positive in 75% of the yolk sac tumor, 75% of mature teratoma, and 75% of immature teratoma specimens. HSP90 was found negative in all choriocarcinoma, mature teratoma, and immature teratoma specimens, while it was positive in 25% of yolk sac tumor, 8.33% of embryonal carcinoma, and 10% of seminoma cases. Concerning the expression of HSP90b, a statistically significant relationship was found between excised tumor specimens and normal parenchyma specimens, especially in sac cases (p <0.001). Regarding HSP90a expression, a statistically significant relationship (OR=21.5, p =0.021) was found between excised tumor specimens and normal parenchyma specimens, especially in embryonal carcinoma cases (p <0.001).

Conclusion: HSP90b is highly expressed in the majority of the types of testicular tumors, both in tumor and normal parenchyma specimens, while HSP90a staining is negative in resected specimens. Further well-designed studies are needed to elucidate the role of HSP90 as a diagnostic marker and therapeutic target in testicular tumors.

Background: Maternal position during delivery can affect the physiology of labour and the mechanics of childbirth.

Objective: The study aimed to evaluate the impact of an upright position during the first stage of labour on maternal outcomes.

Methods: This parallel group randomised control trial was conducted from April to June 2020 among 60 women (30 each in the experimental and control groups) admitted to the selected hospital in Punjab, India. Women who entered the active stage of labour naturally with a single live foetus in cephalic presentation, aged 18-45 years, and with normal body mass index were randomly assigned either to the experimental or control group using a concealed envelope method. Women in the experimental group were informed and encouraged to adopt the upright position, while those in the control group received the standard routine care during the first stage of labour. The effectiveness of upright positions during the first stage of labour was assessed in terms of duration of the first, second, and third stages of labour, mode of delivery, and perineal lacerations. Outcome assessors were blinded to the intervention. The differences in the groups were evaluated by mean, median, frequency, percentage, Chi-square, and t-test.

Results: The results of 60 women were analysed. Women in the experimental group experienced a significant reduction in the incidence of instrumental delivery (p =0.005), perineal laceration (p =0.001), and duration of the first stage (p =0.0001) and third stage (p =0.0001) of labour compared to those in the control group. No harm was reported across the study groups.

Conclusion: This study urges nurses and midwives to recommend the use of upright positions during the first stage of labour to reduce the duration of labour and incidence of perineal laceration among women.

Background: Postpartum hemorrhage (PPH) is one of the three leading causes of maternal mortality. Herbal medicine is one of the well-known methods of treatment in the world.

Objective: This study was conducted to determine and compare the effect of dates, grape seed and dill seed extracts on the PPH rate in women in the fourth stage of labor.

Methods: Two hundred eligible multiparous women visiting the maternity ward in Hamadan for normal delivery participated in this double-blind parallel-group clinical trial. They were randomly divided into four 50-member groups of experiment (3 groups) and control (1 group). The data were collected using a researcher-made questionnaire. In the experimental groups, in addition to routine care and oxytocin administration, the mothers received a capsule containing 15 mg of dill seeds extract or 20 mg of grape seed extract or 5 g of dates extract immediately after the delivery, and then their hemorrhage rates were measured one and two hours after delivery. The control group received routine care, oxytocin, and placebo. Data were analyzed in SPSS 21.

Results: The hemorrhage changes in the placebo group were much less than the intervention groups at 1 and 2 hours after delivery, and the four groups had a significant difference in terms of hemorrhage in both hours (p <0.001). The overall difference between the dates extract group and the placebo and grape seed groups was also statistically significant (p <0.05).

Conclusion: All three extracts of dates, grape seed and dill seeds, especially dates, can be effective in PPH reduction.

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.

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.

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.

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.