Reviews on recent clinical trials最新文献

Introduction: Anti-SS-A antibodies (anti-SS-A) are the most prevalent anti-extractable nuclear antibody (ENA). Glomerulonephritis (GN), characterized by intraglomerular inflammation and cellular proliferation, is the leading cause of end-stage renal failure. The association of anti- SS-A in various types of GN is not well established in the literature. The documented role of anti- SS-A in lupus nephritis (LN) is controversial; some studies did not mention any significant association, whereas others recognized them as potentially pathogenic. This study aimed to determine the association of Anti-SS-A in patients suffering from various GN and its significance in LN patients.

Methods: This cross-sectional study evaluated 200 GN patients for the presence of anti-dsDNA and anti-ENA antibodies via indirect immunofluorescence (IFA) and Immunoblot assays, respectively. All patients had anti-cell antibodies in their sera, which were evaluated with the help of IFA using the HEp-2 cell line as substrate. Data was analyzed using SPSS software version 20. Pvalue ≤ 0.05 was considered statistically significant.

Results: Anti-dsDNA were found in 56(28%) whereas anti-ENA in 94(47%) patients. Anti-SS-A was the most common anti-ENA, which was isolated in 58(29%) patients. In the anti-ENA positive group, single antigen specificity was present in 55 (58.5%) patients, whereas more than one antigen specificity was seen in 39 (41.5%) patients. Out of 58 patients with anti-SS-A antibodies majority presented with nephrotic syndrome 44 (76%), and most of them 51 (88%) had a clinical diagnosis of Lupus Nephritis (LN). Majority patients 31 (53%) also had another anti-ENA along with anti-SS-A (P = 0.05). 24 (41.4%) patients also had anti-dsDNA along with anti-SS-A. In the enrolled GN patients, anti-SS-A antibodies were found to be significantly associated with anti- SS-B and anti-P antibodies.

Discussion: Although anti-SS-A are most prevailing anti-ENA, however their presence in GN patients needs special consideration to rule out an underlying autoimmune disorder. Previous studies have highlighted the pathogenic potential of anti-SS-A in GN patients. The results of this study are in agreement with these studies, as most of the GN patients with anti-SS-A were later on diagnosed as LN. These findings suggest that anti-SS-A may contribute to the disease pathogenesis. However, larger studies in various ethnic populations are needed to confirm these results for adequate patient management.

Conclusion: The study results predict the pathogenic potential of anti-SS-A in GN patients. As the majority of patients were diagnosed as LN, GN patients with anti-SS-A antibodies need special consideration to rule out LN for adequate management.

Background and objectives: Several compounds based on short-chain fatty acids and/or probiotics/prebiotics have shown promising results in the therapy of mild-to-moderate ulcerative colitis (UC). The aim of the present study is to investigate the effectiveness of a preparation based on symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon in patients with active mild-to-moderate UC.

Materials: andMethods: This was a multicentre, retrospective, observational cohort study between January 2023 and June 2023. Disease activity was assessed using the partial Mayo score. Patients were assessed at baseline, at 8-week, and 16-week follow-up (FU). The primary endopoint was clinical response, defined as a partial Mayo score reduction of at least 2 points, whereas C-reactive protein (CRP) and fecal calprotectin (FC) reduction at weeks 8 and 16 were secondary endpoints.

Results: Data were collected at baseline from 17 UC patients (M 8, F 9). Median age at diagnosis was 48 years (IQR 20-80), and median disease duration was 10 years (IQR: 2-23). The clinical response at 8 and 16 weeks was observed in 9/17 (52%) and 11/17 (64%) patients, respectively (p =0.697). No difference was observed regarding CRP values, neither at week 8 nor at week 16. Concerning FC levels, we observed a significant decrease from baseline to week 8, from baseline values of 252 (76-359) μg/g to values of 98 (20-448) μg/g at week 8 (p <0.02); no difference was observed from baseline to week 16. Finally, no adverse events were observed during the study period.

Conclusion: In this preliminary study, the supplementation with the symbiotic association between inulin, fructooligosaccharides (FOS), Lactobacillus rhamnosus GG, bromelin, Boswellia, vitamin D3, quercetin and L-tryptophanon offers real-world potential in controlling disease activity in patients with mild-to-moderate UC. Further multicentre, placebo-controlled, double-blind clinical trials are needed to validate our results on larger cohorts of patients with UC.

Biobanks, repositories of biological samples and associated data, are crucial for advancing our understanding of disease biology. They facilitate long-term sample storage while enabling efficient retrieval for research. However, traditional biobanking practices often struggle to maintain sample quality and uniformity due to repetitive handling and temperature fluctuations during storage and retrieval. The advent of high-throughput "-omics" technologies has further amplified the operational demands on biobanks, necessitating increased scale and agility. Automation offers a solution to these challenges, enabling biobanks to meet the demands of modern research while preserving sample integrity. This review explores the key considerations for establishing an automated biobank, including design principles, essential components, and integration strategies. We discuss various automated storage and retrieval systems, liquid handling platforms, and environmental monitoring tools. Furthermore, we examine the impact of automation on sample quality, data management, and overall biobank efficiency. This review aims to provide a comprehensive overview of automated biobanking, highlighting its potential to revolutionize research and personalized medicine.

Introduction: Breast cancer is a very common disease affecting females on a global scale. It is responsible for approximately 10% of breast cancer-related fatalities. In 2022, approximately 2,308,897 new cases were reported globally. Recent studies focused on breast tumors have successfully recognized somatic mutations. This study aimed to identify previously unidentified somatic mutations in breast cancer patients belonging to Pakistan.

Methods: The breast tumor sample was obtained from Jinnah Hospital, Lahore. The DNA was extracted, and whole-exome sequencing was conducted on six samples.

Results: Gene mutations found include 58.69% synonymous SNV, 28.37% nonsynonymous SNV, 3.89% Frameshift deletion, 6.68% Nonframeshift deletion, 2.09% stopgain, and 0.28% stop loss. Among 39 genes analyzed, the prevalence of gene mutations varied, with HYDIN (100%), ENTHD1 (33.33%), ADRA1B (66.67%), GATA3 (50%), CDH1 (16.67%), RB1 (50%), MAP3K1 (100%), EGFR (50%), TRPM6 (33.33%), KHDRBS1 (33.33%), RBM25 (66.67%), SF3B3 (50%), TEK (16.67%), PGK2 (33.33%), CBFB (33.33%), ARID1A (66.67%), KMT2C (100%), HECTD1 (100%), LAMA3 (66.67%), FLG2 (83.33%), UGT2B4 (16.67%), STK33 (66.67%), ACP4 (50%), DNAH8 (100%), TNN (66.67%), IGSF3 (100%), TRIM67 (83.33%), DNMBP (100%), CORO7 (16.67%), CDC27 (33.33%), ZNF544 (50%), MST1 (16.67%), DENND2A (33.33%), NCKAP5 (50%), PCDHB10 (50%), FBXW7 (50%), EIF4G3 (66.67%), IL12RB2 (50%), and PDE4B (50%).

Discussion: Breast cancer is a fatal disease. The high frequency of synonymous mutations was observed. The HYDIN, MAP3K1, KMT2C, HECTD1, DNAH8, IGSF3, DNMBP genes were 100% mutated then other genes.

Conclusion: This study unveils new somatic alterations in different genes among early-onset Pakistani breast cancer patients, offering valuable insights for drug design targeting breast carcinoma.

Introduction: Reduction in the quantity and quality of ova during the reproductive period of women is a physiological phenomenon. However, in some women, the deterioration of the ovaries occurs suddenly, and they experience infertility due to premature ovarian failure. This study aimed to explore the correlation between Primary ovarian insufficiency (POI) and the pregnancy rate of women in relation to the Tajik lifestyle modification diet.

Methods: In this clinical randomized controlled trial study conducted in 2023, 72 infertile couples were randomly assigned to two groups, control and intervention. The intervention group received Tajik counseling sessions. In cases of normal distribution, the ANCOVA test was used to evaluate the difference between the two groups, and within-group comparisons were made using a paired t-test, while between-group comparisons were made using an independent t-test. A significance level of less than 0.05 was considered.

Results: In comparison to the control group, women with POI exhibited notably lower levels of follicle-stimulating hormone, luteinizing hormone, and prolactin, along with higher anti mullein levels. Within the intervention group, there were 17 successful pregnancies, two miscarriages, and 14 instances of improved menstrual status, resulting in a pregnancy rate of 52.7%.

Discussion: After receiving lifestyle modification advice using the Tajik method, women with POI experienced improvements in their FSH, LH, AMH, and PRL hormone levels, leading to an increase in their pregnancy rate.

Conclusion: According to the results of the present study, the use of the Tajik method is recommended to help treat POI.

Introduction: The pharmaceutical industry has undergone significant regulatory evolution, particularly in India, with the replacement of Schedule Y by the New Drugs and Clinical Trial (NDCT) Rules. These changes reflect India's commitment to ensuring the efficacy, safety, and quality of drugs while aligning with global standards.

Methods: To conduct the literature search for the review, we employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach from 2013 to 2024 for selecting titles and abstracts. The following keywords were used: Clinical Trial Regulations, CDSCO, FDA, and EMA. Further, the databases, such as Medline, PubMed, Embase, and Scopus, were explored for the searches.

Results: The clinical trial framework of India, overseen by the Central Drugs Standard Control Organization (CDSCO), emphasizes expedited approval pathways, ethical oversight by Institutional Ethics Committees (IECs), and cost-effectiveness. Its large and diverse patient pool, along with adherence to Good Clinical Practice (GCP) standards, makes it attractive for multinational trials. Regulatory reforms, such as mandatory trial registration and digital initiatives, further enhance transparency and efficiency.

Discussion: While India shares common ground with the USA and Europe on many regulatory aspects, it stands out for its efficient processes and accessibility, positioning itself as a key hub for global clinical research. Comparisons reveal India's focus on improving efficiency through digitalization and continuous reforms, underscoring its role in advancing clinical trial practices worldwide.

Conclusion: The regulatory evolution of India demonstrates a strong commitment to medical innovation, patient safety, and ethical standards, positioning it as a competitive player in global clinical research. Ongoing collaboration among industry, academia, and regulatory bodies is crucial for addressing emerging challenges and promoting a harmonized, patient-centric approach to clinical trials.

Background: Gestational diabetes mellitus (GDM) is a prevalent metabolic disorder that can occur during pregnancy, leading to various complications for both the mother and the fetus. Additionally, women with gestational diabetes are at a higher risk of experiencing mental health disorders. This study was conducted to investigate the impact of group counselling based on mindfulness on perceived stress in pregnant women with gestational diabetes, given the influence of cognitive-behavioral interventions such as mindfulness on stress and anxiety.

Methods: In this research, 80 pregnant women diagnosed with gestational diabetes were randomly divided into two groups: an intervention and a control. Before the intervention, participants completed a questionnaire that included demographic and obstetric information as well as the Cohen Perceived Stress Questionnaire. The intervention group participated in 8 sessions of mindfulness counselling, with each session lasting between 45 and 60 minutes. Mindfulness sessions focused on emotion regulation. The control group did not receive any intervention. Participants completed the questionnaires one month after the initial intervention in the control group and right after the counselling ended in the intervention group.

Results: The mean score of perceived stress among pregnant women decreased significantly after the intervention (p ˂0.001). There was no difference in socio-demographic characteristics between the groups (p ˃0.05). After the intervention, the perceived stress levels of pregnant women significantly decreased compared to before (from 29.72 (5.33) to 26.10 (5.07)), and after the ANCOVA test, the difference was statistically significant (p ˂0.001).

Conclusion: Mindfulness-based counseling plays an important role in reducing the stress of pregnant women with gestational diabetes through increased awareness, and it can help them control disease conditions, reduce stress, and apply effective coping strategies for stress. Mindfulness- based counseling reduces the perceived stress of pregnant women and thus reduces adverse physical and psychological consequences during pregnancy.

Recent findings suggest that most sports-related injuries occur during the latter stages of these activities, often due to fatigue, which can impair proprioception and increase the risk of injury. Proprioception can be divided into three categories: joint position sense, the sense of movement (kinesthesia), and the sense of force reproduction. While several studies have examined how exercise-induced fatigue affects various aspects of proprioception on lower limb joints, research focusing on the shoulder joint is limited. This comprehensive review of the effects of exercise-induced fatigue on shoulder proprioception aims to summarize the latest evidence and inform practitioners in the fields of fitness and rehabilitation.

Introduction: Healthcare data management, especially in the context of clinical trials, has been completely transformed by cloud computing. It makes it easier to store data, collaborate in real time, and perform advanced analytics across international research networks by providing scalable, secure, and affordable solutions. This paper explores how cloud computing is revolutionizing clinical trials, tackling issues including data integration, accessibility, and regulatory compliance.

Materials and methods: Key factors assessed include cloud platform-enabled analytical tools, collaborative features, and data storage capacity. To ensure the safe management of sensitive healthcare data, adherence to laws like GDPR and HIPAA was emphasized.

Results: Real-time updates and integration of multicenter trial data were made possible by cloud systems, which also showed notable gains in collaborative workflows and data sharing. High scalability storage options reduced infrastructure expenses while upholding security requirements. Rapid interpretation of complicated datasets was made possible by sophisticated analytical tools driven by machine learning and artificial intelligence, which expedited decision-making. Improved patient recruitment tactics and flexible trial designs are noteworthy examples.

Conclusion: Cloud computing has become essential for international clinical trials because it provides unmatched efficiency in data analysis, communication, and storage. It is a pillar of contemporary healthcare research due to its capacity to guarantee data security and regulatory compliance as well as its creative analytical capabilities. Subsequent research ought to concentrate on further refining cloud solutions to tackle new issues and utilizing their complete capabilities in clinical trial administration.

Background: The immunoinformatics approach combines bioinformatics and computational tools, offering a revolutionary method for improving vaccine development by analyzing immune responses at the molecular level. Immunoinformatics enables the creation of customized vaccines designed for specific infections or cancer cells.

Objective: The primary objective of immunoinformatics is to enhance the vaccine development process by predicting and boosting the body's immune response. It aims to identify potential immunogenic epitopes and biomarkers that are important for creating vaccines with greater specificity and efficacy, especially when dealing with large-scale data.

Methods: Immunoinformatics utilizes a combination of proteomic, genomic, and epigenomic data, as well as machine learning algorithms and artificial intelligence techniques. These tools predict how various immunological components, e.g., T-cell and B-cell epitopes, interact with the immune system. This approach allows researchers to avoid traditional trial-and-error methods, enabling the efficient identification of potential vaccine candidates. Additionally, personalized vaccines can be developed by considering individual genetic and immunological characteristics.

Results: The use of immunoinformatics techniques accelerates the screening of vaccine candidates, enhances patient stratification, and optimizes formulations for clinical trials. This approach has been shown to improve vaccine safety, efficacy, and development speed. It also holds promise for managing healthcare on a large scale by producing vaccines tailored to specific populations, thereby improving the overall effectiveness of vaccination programs.

Conclusion: Immunoinformatics represents a transformative approach to vaccine research, improving clinical trial efficiency and enabling the development of more reliable, flexible, and personalized vaccines. This approach has the potential to significantly enhance global healthcare outcomes by accelerating the vaccine development process and optimizing vaccination strategies.