Reviews on recent clinical trials最新文献

Introduction: 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.

Methods: 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.

Results: 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).

Discussion: 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.

Conclusions: 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.

Introduction: 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.

Methods: 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.

Results: 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).

Discussion: 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.

Conclusion: 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.

Clinical trial registration number: CTRI -REF/2023/05/066900.

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.

Psoriasis is a chronic inflammatory skin disorder that presents ongoing challenges in its management. Current therapeutic approaches, including topical agents, phototherapy, systemic immunomodulators, and biologics, focus on symptom alleviation and improving patients' quality of life. Nonetheless, several limitations exist, such as adverse effects associated with treatments, the emergence of resistance, high costs, and significant inter-individual variability in therapeutic responses. Recent advancements in psoriasis management show promise in developing novel therapeutic agents. Biologics targeting underexploited pathways, particularly interleukin-23 inhibitors like lebrikizumab, have shown superior efficacy profiles. Small molecule inhibitors, such as RORγt and ROCK2 inhibitors, have broadened the therapeutic landscape. Combination regimens, including biologics in conjunction with methotrexate, may enhance overall treatment efficacy. Innovations in topical drug delivery systems, particularly through the use of microneedles and nanoparticle-based carriers, provide the potential for improved therapeutic outcomes. Moreover, the integration of biomarkers and multi-omics approaches holds substantial promise for personalized treatment strategies, refining diagnostic precision and predicting treatment responses while guiding therapeutic decisions. Collaborating among researchers, clinicians, and industry stakeholders is crucial to translating these scientific advancements into clinical practice. By addressing existing challenges and leveraging these emerging therapies, we can significantly enhance the management of psoriasis and improve patient outcomes for this chronic condition.

Introduction: 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.

Methods: 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.

Results: 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.

Discussion: 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.

Conclusion: While valerian appears promising for primary dysmenorrhea, further standardized RCTs are needed to confirm efficacy and address heterogeneity.

Introduction: 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.

Methods: 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.

Results: 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.

Discussion: 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.

Conclusion: 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.

Introduction: Radiotherapy (RT) is an integral component of various multidisciplinary treatment approaches for pelvic malignancies, used both in the radical and adjuvant setting. Despite the improvement of radiotherapy modalities, pelvic radiotherapy often induces permanent erectile dysfunction (ED). However, post-treatment ED receives little medical attention, since patient follow-up focuses mainly on cancer recurrence surveillance. The present review aims to summarize the current treatment modalities against radiation-induced erectile dysfunction (RIED) for patients who have received pelvic radiotherapy.

Methods: A literature review on emerging treatment strategies for RIED was conducted to summarize existing evidence. Research in medical literature was conducted through the PubMed Central databases, from 1996 up until June 2024, in the English language. All relevant clinical trials on RIED management were included.

Results: The efficacy of PDE5i was investigated by 12 research studies. The majority of studies revealed that PDE5i have a potentially positive effect on maintaining EF, mainly in the shortterm after pelvic RT. Despite penile prostheses' high efficacy, their role remains limited due to various factors. Regarding yoga, a randomised clinical trial demonstrated clinical effectiveness only during the first 4 weeks of the twice/week regimen of sessions.

Discussion: Treatment strategies for RIED range from oral medication to more invasive treatment modalities that present high efficacy. Penile prosthesis remains the most invasive, yet the most effective and definitive treatment. Stem cell therapy, platelet-rich plasma intracavernosal injections, and penile vibratory stimulation feature an efficient profile, but their beneficial role has not yet been established. Further randomized controlled trials are required to assess the effectiveness of these interventions.

Conclusion: Establishing strategies for the needs of survivors with RIED should also be prioritized in the therapeutic management, because patients' quality of life can be substantially improved.

Introduction: The management of clinical trial data is an essential component of medical research, where accuracy, security, and transparency directly impact the validity of outcomes. However, conventional methods often face challenges in maintaining data integrity and compliance with regulatory standards. The transformative role of Artificial Intelligence (AI) in enhancing these aspects by leveraging machine learning and analytics offers promising capabilities to improve data validation, detect inconsistencies, and secure sensitive information, thereby increasing credibility among researchers, participants, and regulators. The aim of this study is to explore the transformative potential of artificial intelligence in enhancing clinical trial data management. It specifically investigates whether AI can improve data integrity, transparency, and security, thus making the results credible to the researcher, participant, and regulatory bodies involved.

Methods: The study employs machine learning algorithms and advanced analytics to investigate the role of AI in identifying data anomalies, verifying the accuracy of information, and validating data processes. Case studies and real-world applications are presented to highlight how AI enables real-time monitoring, reporting, and verification of regulatory compliance. It also analyzes encryption and access control systems powered by AI, ensuring that sensitive clinical trial data is protected against breaches and unlawful access.

Results: The findings demonstrate that AI significantly streamlines the management of clinical trial data through automated data validation processes, the detection of inconsistent data, and the capability for real-time data monitoring. AI encryptions and access control systems minimize data security risks to safeguard sensitive information. Case studies demonstrate that transparency, regulatory compliance, and stakeholder trust improve when AI is integrated into clinical trial processes.

Discussion: The study shows AI significantly enhances clinical trial data management through automated validation, real-time monitoring, and anomaly detection. Throughout the trial process, these capabilities reduce errors, ensure regulatory compliance, and improve transparency. Additionally, AI-driven encryption and access control systems offer robust protection against data breaches, reinforcing participant confidentiality and stakeholder trust. Case study analysis demonstrates that AI not only streamlines data workflows but also fosters greater confidence in trial outcomes, signaling a shift toward more efficient, secure, and credible AI-enabled clinical trials.

Conclusion: The study highlights the potential of AI to revolutionize the management of clinical trial data with aspects such as data integrity, transparency, and security. The incorporation of AI ensures the credibility of t

Background: The pharmaceutical industry operates within a complex regulatory environment, requiring strict compliance with global guidelines. Regulatory affairs (RA) departments are pivotal in ensuring drug approvals and compliance. However, the increasing complexity and volume of regulatory requirements have put a strain on traditional processes, driving the adoption of automation tools to streamline these operations.

Objective: This review aims to explore the key automation tools used in regulatory affairs, focusing on their role in streamlining submissions, ensuring compliance, centralizing data, and reducing human error. It also aims to examine the emerging technologies in the field and their potential for enhancing automation.

Methods: A comprehensive review of current automation tools in regulatory affairs was conducted. The key tools explored include Submission Management Systems (SMS), Regulatory Information Management (RIM) systems, Electronic Document Management Systems (EDMS), and Regulatory Intelligence Tools. Additionally, the role of emerging technologies like Artificial Intelligence (AI) and Machine Learning (ML) in automating regulatory processes was evaluated.

Results: Automation tools such as SMS, RIM, EDMS, and Regulatory Intelligence Tools have been found to significantly improve the efficiency of regulatory affairs operations. These tools streamline submissions, centralize data, and ensure compliance. AI and ML technologies further enhance automation by enabling predictive analytics and automating risk assessments. Despite the advantages, challenges remain, including high implementation costs, data security concerns, and the need to adapt to varying global regulations. However, overcoming the challenges and limitations associated with these technologies in adopting regulatory automation is crucial.

Discussion: This study highlights that automation tools are important for modernizing regulatory affairs by improving efficiency, accuracy, and compliance. The integration of Artificial Intelligence (AI) and Machine Learning (ML) adds predictive and adaptive capabilities, transforming static processes into dynamic systems. These technologies hold immense potential to reshape regulatory operations globally.

Conclusion: Automation tools are becoming essential in the pharmaceutical industry to maintain regulatory compliance, reduce time-to-market, and manage the increasing complexity of drug development in a globalized industry. As emerging technologies like AI, ML, and blockchain continue to evolve, they promise to further revolutionize regulatory affairs processes.