Reviews on recent clinical trials最新文献

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.

Background: Huntington's disease (HD) is a neurodegenerative disorder due to a CAG trinucleotide repeat expansion in the HD gene. Animal models have been instrumental in revealing the genetic and molecular bases of HD. While animal models cannot exactly model the human disease because of anatomical and lifespan differences, they are essential in revealing HD pathology and possible treatments.

Objective: This review aimed to highlight the significance of animal models, particularly rodents, in deepening our knowledge of Huntington's disease. It underlines how non-genetic and genetic models have aided research and therapy innovation as well as their limitations.

Methods: This review addresses the use of different models of animals, including genetic models, such as transgenic mice and non-genetic models, for example, invertebrates and non-human primates. It addresses the creation of these models through methods, such as gene transfer techniques and transgenic manipulation, to simulate the genetic defects that occur in humans. The applicability of model choice based on validity criteria, including symptom manifestation and treatment effectiveness, is also discussed.

Results: This study underscores the effectiveness of the R6/2 mouse model, characterized by accelerated symptom onset and HD pathology. Progress in genetic engineering has also boosted the construction of murine and rat models that reproduce the hereditary aspects of HD, providing significant platforms for experimental investigation.

Conclusion: Even with their limitations, animal models, especially rodents, continue to play a vital role in the study of HD pathogenesis and therapeutic intervention. These models still shed light on the disease and direct towards the identification of effective treatments.

Introduction: Pressure injuries (PIs) pose a significant threat to the safety of hospitalized, mobility-compromised patients globally. Olive oil has shown promising results in preventing PIs due to its high concentrations of monounsaturated fatty acids and phenol antioxidants, known for their anti-inflammatory and cell-protective properties. This study aimed to evaluate the effectiveness of topical olive oil combined with routine preventive interventions in reducing PI incidence.

Methods: A single-blinded, cluster-randomized study was conducted among 80 hospitalized patients at risk of developing PIs. Participants were randomized into two clusters: the intervention group (IVG, n=40) received standard PI preventive care (skin assessment, repositioning, support surfaces) plus topical olive oil application for 7 consecutive days; the control group (CG, n=40) received only standard care. PI prevalence and Braden Scale scores were assessed at baseline and post-intervention (days 3-8). Data were analyzed using descriptive statistics and paired sample ttests.

Results: At baseline, both groups had a PI prevalence of 52.5% (n=21). After the intervention, prevalence reduced to 5% (n=2) in IVG and 22.5% (n=9) in CG. The Braden Scale score in the IVG declined from 12.45±0.50 to 11.75±1.13. Statistically significant improvements were observed in Braden scores between day 1 and day 3 (IVG: x̄= -0.28±0.55, t= -3.14, p <0.05; CG: x̄= -0.58±4.69, t= -4.66, p <0.05) and between day 1 and day 8 (IVG: x̄= -0.70±1.07, t= -4.15, p <0.05; CG: x̄= 1.38±1.58, t= -5.50, p <0.05).

Discussion: The findings underscore the clinical benefit of incorporating topical olive oil into standard PI preventive care. The significant reduction in PI prevalence and improved Braden Scale scores suggest olive oil's potential role as a protective agent due to its anti-inflammatory and antioxidant properties. These results align with existing literature on natural oil-based interventions for skin integrity. However, limitations include the small sample size and short duration, warranting further large-scale studies.

Conclusion: Topical olive oil, when used alongside standard care practices, significantly reduced the incidence of pressure injuries in hospitalized, at risk patients. This approach could serve as a cost-effective, natural adjunct to PI prevention protocols, particularly in resource-limited healthcare settings.

Background: Colonoscopy is a critical tool for the management of Ulcerative Colitis (UC). In this study, we aim to explore the accuracy of Virtual Chromoendoscopy (VCE) using Narrow Banding Imaging (NBI), and magnification using Near Focus (NF) for a better definition of endoscopic inflammation grade in UC patients compared to standard white light (WL) endoscopy alone.

Methods: This is a non-randomized prospective study including all the patients who underwent a colonoscopy (for any reason) between April and September 2023 (with protocol number n. 60/2019.20). During the endoscopic evaluation, at least one image with white light - evaluated using the Mayo Endoscopic Score (MES), one image with NBI, one image with NBI plus NF, and a biopsy were obtained in each colonic tract (cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum). All the stored images were evaluated by three endoscopists separately and compared with the results of the histological evaluation.

Results: A total of 31 UC patients were included. The inter-rater reliability concerning the different scores used (MES, NBI score, and NBI plus NF score), which was evaluated with Cohen's kappa coefficient, was good for the MES, good to excellent for the NBI score, and good for the NBI plus NF score. The concordance between histological evaluation (using the Nancy Index) and the MES was unsatisfactory for all the endoscopists, while the concordance between the NBI evaluation score and the Nancy Index was good to excellent.

Conclusion: The results in the present study suggest that the new endoscopic technologies could be useful to better define disease activity in IBD patients driving better therapeutic strategy.

Introduction: 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.

Methods: A comprehensive analysis of randomized controlled trials (RCTs) involving breastcancer survivors was conducted across major databases, including PubMed, Scopus, Embase,CINAHL, Cochrane Library, and ClinicalTrials.gov. Studies were selected based on theirevaluation of lifestyle interventions aimed at reducing breast cancer risk and its recurrence and orimproving survival. Non-RCTs and studies focusing solely on pharmacological or geneticinterventions were excluded. The risk of bias in included randomized controlled trials wasassessed using the Cochrane Risk of Bias 2 (RoB 2). The results of the included studies werepresented in tabulated form.

Results: Physical activity emerged as the most effective intervention, significantly enhancingmetabolic health, body composition, and cardiorespiratory fitness. Dietary changes and weightmanagement programs provided secondary health benefits, such as modest improvements in dietquality, metabolic markers, and quality of life. The combined intervention of diet and exercisefurther improved these outcomes although it did not significantly reduce cancer recurrence. Thedigital support system (EMPOWER-SMS) was feasible and acceptable, offering minorimprovements in medication adherence and self-efficacy, though its effects on BMI and qualityof life were less pronounced.

Discussion: Among the various lifestyle interventions explored for breast cancer survivors,physical activity consistently emerged as the most effective in improving health outcomes. Whiledietary 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 improvementsin quality of life, making a combined approach potentially the most comprehensive forsupporting breast cancer survivors. This systematic review's limitations include interventionheterogeneity, varied follow-up durations, inconsistent outcome measures, small sample sizes,lack of control over confounding variables, limited participant diversity, potential publicationbias, and a focus on short-term outcomes.

Conclusion: Physical activity emerged as the most beneficial lifestyle intervention for breastcancer survivors, particularly when combined with dietary modifications and weightmanagement. A holistic approach that integrates physical activity, dietary changes, and digitalsupport may provide the most comprehensiv