Reviews on recent clinical trials最新文献

{"title":"Chemical Perspectives on Epigallocatechin-3-Gallate (EGCG): Mechanisms and Therapeutic Potential in Breast Cancer Treatment.","authors":"Sakshi Patel, S K Abdul Rahaman, Prem Shankar Mishra, Rahul Kumar","doi":"10.2174/0115748871386534251004122533","DOIUrl":"10.2174/0115748871386534251004122533","url":null,"abstract":"<p><p>Green tea contains a bioactive polyphenol called epigallocatechin gallate (EGCG), which may be used as a therapeutic agent for breast cancer (BC). This review examines the pharmacological and chemical properties of EGCG, which may make it a valuable therapeutic agent for treating breast cancer. The distinctive physicochemical characteristics of EGCG, such as its solubility, stability, and bioavailability, are based on its molecular structure, which is also crucial for its medicinal uses. Furthermore, the availability of EGCG as a naturally occurring substance, its production in \"Camellia sinensis,\" and the use of sophisticated extraction methods are also covered. Apoptosis is induced via caspase activation and mitochondrial failure. Metastasis-related enzymes are inhibited, and key signaling pathways, including PI3k, Akt, and MAPK, are modulated as part of EGCG's multifaceted anti-cancer actions. The synergistic benefits of EGCG with traditional chemotherapies, in combating drug resistance and enhancing their effectiveness, significantly improve the therapeutic value of these treatments. Limited bioavailability is addressed via liposomal delivery, nanoparticle encapsulation, and structural optimisation. Pharmacokinetics, toxicology, and clinical studies all support its safety and effectiveness. This study highlights the promise of EGCG as a therapeutic agent for breast cancer, exploring its molecular interactions, new formulations, and the integration of chemistry and molecular mechanisms to enhance EGCG's therapeutic applicability in clinical settings.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"e15748871386534"},"PeriodicalIF":1.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145355888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating the Impact of Lifestyle Interventions on Health Outcomes in Breast Cancer Survivors: A Systematic Review.","authors":"Sana Jameel, Tuba Razi, Gulafshan Fatima, Abiha Ahmad Khan, Syeda Aamena Naaz, Hina Meraj","doi":"10.2174/0115748871357938250612102627","DOIUrl":"10.2174/0115748871357938250612102627","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Lifestyle interventions have been increasingly studied for their potential to improve health outcomes in breast cancer survivors. However, the relative effectiveness of these interventions remains unclear. This study aimed to evaluate the impact of various lifestyle changes on the health outcomes of breast cancer survivors.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A comprehensive analysis of randomized controlled trials (RCTs) involving breast cancer survivors was conducted across major databases, including PubMed, Scopus, Embase, CINAHL, Cochrane Library, and ClinicalTrials.gov. Studies were selected based on their evaluation of lifestyle interventions aimed at reducing breast cancer risk and its recurrence and or improving survival. Non-RCTs and studies focusing solely on pharmacological or genetic interventions were excluded. The risk of bias in included randomized controlled trials was assessed using the Cochrane Risk of Bias 2 (RoB 2). The results of the included studies were presented in tabulated form.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Physical activity emerged as the most effective intervention, significantly enhancing metabolic health, body composition, and cardiorespiratory fitness. Dietary changes and weight management programs provided secondary health benefits, such as modest improvements in diet quality, metabolic markers, and quality of life. The combined intervention of diet and exercise further improved these outcomes although it did not significantly reduce cancer recurrence. The digital support system (EMPOWER-SMS) was feasible and acceptable, offering minor improvements in medication adherence and self-efficacy, though its effects on BMI and quality of life were less pronounced.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Among the various lifestyle interventions explored for breast cancer survivors, physical activity consistently emerged as the most effective in improving health outcomes. While dietary changes, weight management, and combined interventions also offered health benefits, their direct impact on key outcomes like cancer recurrence and survival was less clear. However, when integrated with regular exercise, these interventions contributed to holistic improvements in quality of life, making a combined approach potentially the most comprehensive for supporting breast cancer survivors. This systematic review's limitations include intervention heterogeneity, varied follow-up durations, inconsistent outcome measures, small sample sizes, lack of control over confounding variables, limited participant diversity, potential publication bias, and a focus on short-term outcomes.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;Physical activity emerged as the most beneficial lifestyle intervention for breast cancer survivors, particularly when combined with dietary modifications and weight management. A holistic approach that integrates physical activity, dietary changes, and digital support may provide the most comprehensiv","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"e15748871357938"},"PeriodicalIF":1.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144542065","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Microscopic Colitis and Gut Microbiota: A Narrative Review.","authors":"Carmen Colaci, Giuseppe Guido Maria Scarlata, Alessandro Corea, Caterina Mercuri, Francesco Luzza, Patrizia Doldo","doi":"10.2174/0115748871392729250910205323","DOIUrl":"10.2174/0115748871392729250910205323","url":null,"abstract":"<p><p>Microscopic colitis (MC) is a chronic inflammatory disorder of the colon, characterized by diarrhea, abdominal pain, and weight loss. It encompasses two different subtypes: collagenous colitis and lymphocytic colitis, distinguished by specific histopathological features. The cause of MC remains largely unknown, although genetic, environmental, and immune factors have been recognized as possible risk factors. Recent research has highlighted the potential role of the gut microbiota in the pathogenesis of MC, with an increasing body of evidence suggesting that alterations in the composition and diversity of the gut microbiota may contribute to the development and progression of the disease. This narrative review aims to summarize current findings on the relationship between the gut microbiota and microscopic colitis, exploring the mechanisms through which microbial dysbiosis could influence intestinal inflammation and affect clinical outcomes. We discuss the impact of specific bacterial taxa, the role of the gut immune system, and the potential therapeutic implications of microbiota modulation in MC. Additional investigation is required to gain a comprehensive understanding of the microbiota-associated mechanisms driving MC and to evaluate the potential of microbiota-targeted treatments for individuals affected by this condition.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"e15748871392729"},"PeriodicalIF":1.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138527","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Prospective Study on the Role of Strain Echocardiography in Detecting Early Radiation-induced Cardiotoxicity in Left-sided Breast Cancer Patients.","authors":"Areti Gkantaifi, Christodoulos Papadopoulos, Maria Toumpourleka, Maria Marketou, Davide Mauri, Georgios Giakoumettis, Dimitris Mavroudis, Maria Tolia","doi":"10.2174/0115748871338729250418152731","DOIUrl":"10.2174/0115748871338729250418152731","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Discussion: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"30-35"},"PeriodicalIF":1.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144014925","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Quality of Methodological Reporting of Randomised Controlled Trial (RCT) Articles Published in Iranian and Top Nursing and Midwifery Journals Indexed in the Scopus Database using the CONSORT Checklist: A Cross-sectional Study.","authors":"Razieh Bagherzadeh, Siavash Asadzadeh Jahanabad, Leila Dehghani","doi":"10.2174/0115748871331785250415055616","DOIUrl":"10.2174/0115748871331785250415055616","url":null,"abstract":"<p><strong>Introduction: </strong>The quality of methodological reporting in randomized controlled trials (RCTs) is crucial for guiding healthcare decisions. This study compares the methodological reporting of RCT articles published in Iranian nursing and midwifery journals indexed in Scopus with those published in international nursing and midwifery journals also indexed in Scopus.</p><p><strong>Methods: </strong>This comparative cross-sectional study reviewed RCT articles from eight Iranian Scopus- indexed journals (381 articles) and three journals with the highest CiteScore index (204 articles) from 2017 to 2021. Data were collected using the methodology section of the CONSORT checklist. SPSS 19 software was used for data analysis.</p><p><strong>Results: </strong>The average percentages of methodological reporting in the top three Iranian journals were 76.4% and 84.4%. The mean quality score of methodological reporting in Iranian nursing and midwifery journals was significantly lower than that in international journals published from 2017-2021 (P <0.001). Underreporting was observed in both groups, particularly regarding randomization and blinding.</p><p><strong>Discussion: </strong>Our findings align with previous studies indicating that adherence to reporting standards, such as CONSORT guidelines, is more common in higher-impact journals. Deficiencies in reporting elements, such as randomization and blinding, undermine confidence in study results.</p><p><strong>Conclusion: </strong>The average quality of methodological reporting in Iranian journals is lower than that in the top three Scopus-indexed journals. Journals with lower reporting quality, like Iranian journals, can enhance article quality by adhering to reporting guidelines for all article types, including RCTs.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"36-43"},"PeriodicalIF":1.2,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144009165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Integrated Evaluation of IL-8 Levels and the In Silico and In Vitro Effects of Ellagic Acid against Extended-spectrum β-lactamase in Biofilm-forming Klebsiella pneumoniae Isolated from Urinary Tract Infections.","authors":"Mohammed Mukhles Ahmed, Haneen Emad Khadum, Samer N Khalaf, Ali Hazim Abdulkareem","doi":"10.2174/0115748871349421251105115035","DOIUrl":"https://doi.org/10.2174/0115748871349421251105115035","url":null,"abstract":"<p><strong>Introduction: </strong>Urinary tract infections (UTIs) caused by multidrug-resistant, biofilmforming Klebsiella pneumoniae represent a serious global health concern. Conventional antibiotics often fail due to resistance and biofilm-associated tolerance, necessitating novel diagnostic and therapeutic strategies. This study investigated interleukin-8 (IL-8) as a diagnostic marker and evaluated the anti-virulence potential of ellagic acid against extended-spectrum β-lactamase (ESBL)-producing K. pneumoniae.</p><p><strong>Methods: </strong>This study was a cross-sectional, experimental, and analytical investigation conducted from August 2023 to March 2024. Serum IL-8 levels were quantified in patients and healthy controls using ELISA. The antibiotic susceptibility of K. pneumoniae isolates was assessed according to CLSI guidelines, and ESBL activity was determined by the nitrocefin hydrolysis test. Biofilm formation was quantified using the crystal violet assay, with and without ellagic acid treatment. In silico docking studies were conducted using AutoDock Vina to predict interactions between ellagic acid and the CTX-M-15 β-lactamase, Wza, FabH, and SdiA proteins.</p><p><strong>Results: </strong>IL-8 levels were significantly higher in patients (223.8 ± 43.5 pg/mL) compared with controls (47.9 ± 17.3 pg/mL; p < 0.0001). All isolates were resistant to ampicillin and showed broad resistance to other antibiotics. Ellagic acid significantly reduced biofilm biomass (p = 0.0002) but concurrently increased ESBL activity (p = 0.0001). Docking demonstrated that ellagic acid was strongly bound to CTX-M-15 (-8.3 kcal/mol), had moderate interactions with Wza and SdiA, whereas the interaction with FabH was relatively low.</p><p><strong>Discussion: </strong>The high concentration of IL-8 supports its use as a biomarker to detect K. pneumoniae infections. The elevated resistance profile of K. pneumoniae to antibiotics highlights the urgent need for alternative treatment approaches. Though ellagic acid increased ESBL activity, it showed distinct antibiofilm activity and responses with virulence-related proteins, indicating a modulatory action that may reduce bacterial pathogenicity. Limitations include the lack of in vivo validation and the need to mechanistically elucidate the modulation of ESBL.</p><p><strong>Conclusion: </strong>IL-8 is a valuable biomarker for ESBL-producing K. pneumoniae infection. Ellagic acid reduces biofilm formation and targets bacterial resistance and virulence proteins, supporting its potential as a natural anti-virulence agent against multidrug-resistant K. pneumoniae.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145655369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Calcium Sulfate as a Local Antibiotic Delivery Vehicle in Chronic Osteomyelitis Following Internal Fixation: A Prospective Case Series.","authors":"Mohammed Jaffer Jawad, Raed Abbas Saadoon, Wassan Nori Mohammed Hassan","doi":"10.2174/0115748871425903250909144103","DOIUrl":"https://doi.org/10.2174/0115748871425903250909144103","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic osteomyelitis is a complex and persistent orthopedic infection. Antibiotic-loaded calcium sulfate (CS) has promoted the eradication of infection and bone regeneration. To evaluate the early and mid-term clinical outcomes of antibiotic-impregnated CS in the management of chronic osteomyelitis following internal fixation.</p><p><strong>Methods: </strong>A prospective interventional case series included (n=15) patients with chronic osteomyelitis treated at Al Yarmouk Teaching Hospital. The patient's medical, surgical history, Additionally, patients' and physical examination were recorded. inflammatory markers and microbiological culture from sinus discharge. Imaging was performed to classify the type of infection according to the Cierny and Mader classification. All patients underwent extensive surgical debridement and implantation of CS loaded with vancomycin or tobramycin, and systemic antibiotics were administered according to culture results. Patients were followed up for 1 year to assess functional scores and infection eradication.</p><p><strong>Results: </strong>The mean age was 36.86±9.41 years, with 66.7% male and 33.3% female. Tibia was involved in (46.7%). Methicillin-Resistant Staphylococcus Aureus was isolated in (66.67%) of all cases. After a one-year follow-up, all cases achieved infection resolution. Functional scores improved significantly, from 26.8 to 64.2 (P < 0.001).</p><p><strong>Discussion: </strong>Antibiotic-loaded CS as an adjuvant to surgical debridement and systemic antibiotics shows promising results with higher rates of infection eradication and significant functional improvement.</p><p><strong>Conclusions: </strong>Using CS loaded with antibiotics as complementary therapy with systemic antibiotics demonstrated significant infection control and functional recovery in patients with chronic osteomyelitis following internal fixation during the early and mid-term follow up. Future studies need a larger sample and a longer follow up.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of Maternal Oral Glucose Intake in Improving Blood Glucose Levels in Hypoglycemic Neonates; A Randomized Controlled Trial.","authors":"Bharat Pareek, Ramya Kundayi Ravi, Daljit Kaur, Rishu Thakur, Maria Mattu, Jyoti Shika","doi":"10.2174/0115748871393641250908074928","DOIUrl":"https://doi.org/10.2174/0115748871393641250908074928","url":null,"abstract":"<p><strong>Introduction: </strong>Neonatal hypoglycemia, a common metabolic condition requiring prompt recognition, timely intervention, and careful monitoring to prevent adverse neurodevelopmental outcomes, can be effectively treated with glucose intake through breast milk, a simple and cost-effective approach. This study aimed to evaluate the effectiveness of oral glucose intake by nursing mothers in increasing blood glucose levels in hypoglycemic newborns.</p><p><strong>Methods: </strong>A parallel-group randomized control trial was conducted from July to August 2023 with 60 postnatal mothers and their newborns admitted to a government hospital in Punjab, India. Participants were randomly assigned to either the experimental or the control group using the concealed envelope method. Mothers in the experimental group received 35 g of oral glucose mixed with 200 ml of water once daily, whereas those in the control group received standard treatment. The outcome was assessed by measuring newborns' random blood glucose levels six hours post-intervention. The outcome assessors were blinded to the interventions. The study adhered to CONSORT guidelines, and statistical analysis was performed using mean, median, frequency, percentage, Chi-square, One-way ANOVA, and t-test.</p><p><strong>Results: </strong>The post-intervention mean ± SD random blood glucose levels were 61.77 ± 7.238 in the experimental group and 53.80 ± 5.081 in the control group, showing a statistically significant difference (p ≤0.001).</p><p><strong>Discussion: </strong>The results align with emerging evidence on maternal dietary influence on breast milk composition and neonatal health. However, limitations such as the small sample size and short-term outcome assessment necessitate further research to confirm and expand upon these findings.</p><p><strong>Conclusion: </strong>Oral glucose intake by lactating mothers significantly increased newborn blood glucose levels, demonstrating its effectiveness as a simple, noninvasive, and cost-effective intervention for neonatal hypoglycemia.</p><p><strong>Clinical trial registration number: </strong>CTRI -REF/2023/05/066900.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145186687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Valeriana officinalis on Primary Dysmenorrhea: A Systematic Review and Meta-Analysis.","authors":"Fatemeh Rabiei, Moloud Aghajani Delavar, Parvaneh Mirabi, Parisa Masoumi, Athar Jahanshahi","doi":"10.2174/0115748871387235250902123910","DOIUrl":"https://doi.org/10.2174/0115748871387235250902123910","url":null,"abstract":"<p><strong>Introduction: </strong>Primary dysmenorrhea, defined by painful menstruation in the absence of pelvic disorders, often requires treatment. Traditional options such as NSAIDs and oral contraceptives have limitations. This systematic review and meta-analysis evaluate the efficacy of Valeriana officinalis (Valerian) in managing primary dysmenorrhea.</p><p><strong>Methods: </strong>We conducted a comprehensive literature search (2000-November 2023) for RCTs comparing valerian to placebo or NSAIDs in primary dysmenorrhea. The primary outcome was a reduction in dysmenorrhea pain. Risk of bias was assessed using Cochrane's tool.</p><p><strong>Results: </strong>Five controlled trials (201 intervention, 207 control participants) met the inclusion criteria. The random-effects model showed a significant pain reduction with valerian versus control (SMD = -1.03; 95% CI, -1.74 to -0.33; P < 0.004). Heterogeneity was high (Cochrane's Q test: P < 0.001; I² = 90.40%). Valerian was safe and well-tolerated.</p><p><strong>Discussion: </strong>Valerian significantly reduced dysmenorrhea pain by 1.03 points on a VAS 0-10 scale, though high heterogeneity and limited studies necessitate cautious interpretation. Potential mechanisms (e.g., GABA modulation) may underlie its effects, but variability in dosing and trial designs complicates comparisons.</p><p><strong>Conclusion: </strong>While valerian appears promising for primary dysmenorrhea, further standardized RCTs are needed to confirm efficacy and address heterogeneity.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145081380","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cybersecurity, Research Data Management (RDM), and Regulatory Compliance in Clinical Trials.","authors":"Virendra S Gomase","doi":"10.2174/0115748871360236250901072442","DOIUrl":"https://doi.org/10.2174/0115748871360236250901072442","url":null,"abstract":"<p><strong>Introduction: </strong>The intersection of drug discovery and cybersecurity is becoming critical as the pharmaceutical sector adopts digital technologies to drive research and development. Drug discovery entails extensive collaboration and large volumes of data, making it highly susceptible to cyberattacks. Emerging technologies, such as big data analytics, artificial intelligence (AI), and cloud computing, hold significant innovation potential but also pose risks to the industry that can undermine intellectual property (IP), clinical trial results, and collaborative research. This review discusses the importance of cybersecurity in the drug discovery process. The focus is on determining major threats, defining best practices for protecting sensitive information, and ensuring compliance with regulatory requirements. The objective is to highlight the strategic significance of cybersecurity practices in protecting research integrity and fostering innovation.</p><p><strong>Methods: </strong>The review-based approach is employed to analyze present-day trends in drug discovery cybersecurity. Emerging technologies, security issues, regulatory needs, and the security controls most frequently utilized in the industry, such as encryption, multi-factor authentication, and secure data sharing, are discussed in the chapter.</p><p><strong>Results: </strong>The pharmaceutical sector has advanced significantly in securing sensitive research information through robust cybersecurity measures. However, the vulnerabilities remain for cloud security as well as for protecting AI models. Adhering to the regulatory guidelines of GDPR (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act) remains a concern as international norms evolve.</p><p><strong>Discussion: </strong>As digital technologies transform drug discovery, cybersecurity has become crucial in protecting sensitive data and intellectual property rights. Strengthening compliance with evolving regulations is key to ensuring safety and innovative pharmaceutical research.</p><p><strong>Conclusion: </strong>Cybersecurity is critical in preserving the integrity of drug discovery. With the increasing adoption of digital technologies, pharmaceutical firms must implement robust cybersecurity measures to protect sensitive information, ensure compliance, and foster innovation in a secure environment.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":""},"PeriodicalIF":1.0,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145065162","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}