Reviews on recent clinical trials最新文献

Introduction: Understanding the public perception of colorectal cancer screening is crucial since early diagnosis lowers mortality rates associated with this type of cancer.

Methods: The purpose of this study was to determine the most popular technique for colorectal cancer screening in Saudi Arabia. From September 2021 to February 2022, a cross-sectional study on adult Saudi population was undertaken. Data were collected through a self-created survey distributed via an online platform.

Results: Out of 10,781 participants analyzed, 5,612 were found suitable for evaluating preferences between colonoscopy and fecal immunochemical test (FIT) as screening modalities. It was found that gender, employment, and age were important predictors for the preferred screening modality.

Conclusion: More attention should be paid to the population's preferred method for colorectal cancer screening, which could increase the success of the screening effort.

Introduction: Anti-melanoma Differentiation-associated Gene 5 (aMDA5) antibody-associated Rapidly Progressive Interstitial Lung Disease (RP-ILD) is a rare and potentially fatal condition.

Case presentation: This case report describes a 78-year-old male who presented with a 10-day history of fever, cough, and asthenia. Despite initial treatment for suspected atypical pneumonia, the clinical condition rapidly deteriorated, necessitating intensive care and mechanical ventilation. High-resolution CT scans revealed a progressive interstitial lung disease with pneumomediastinum. Autoimmunity blood tests revealed high-titer anti-MDA5 antibodies bringing to a diagnosis of anti-MDA5 RP-ILD. Despite aggressive immunosuppressive therapy, the patient's condition continued to worsen, resulting in death. Our case underlines the importance of early recognition and diagnosis of anti-MDA5 RP-ILD, as it can present without typical dermatomyositis skin manifestations. The report also includes a comprehensive literature review covering the pathogenesis, clinical manifestations, diagnosis, and treatment options for anti-MDA5-associated disease.

Conclusion: This case underscores the need for increased awareness of this condition among clinicians to improve early diagnosis and treatment outcomes.

Introduction: Breast cancer radiotherapy has a clear benefit for both long-term survival and local control rate. However, healthy surrounding normal tissues, including the heart and lungs, can negatively impact a patient's quality of life.

Objective: This study aims to clarify the contribution of echocardiography with Global Longitudinal Strain to early radiation-induced cardiotoxicity detection.

Methods: The sample of our prospective study consists of 25 patients with early-stage left-sided breast cancer. 2D strain echo was estimated on all patients before and one year after radiotherapy. For the control of the normality of the condition, the Shapiro-Wilk test and the study of graphical representation of the «Box Plot» were used. For the comparative analysis of average values of a continuous variable and between two-time points, the Wilcoxon test was used. SPSS 25 software was used for the statistical processing of the data.

Results: Mean Global Longitudinal Strain value before and one year after radiotherapy was -20.2% and -21.2%, respectively. In half of the 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).

Conclusion: Our study did not detect any significant difference in the mean Global Longitudinal Strain pre and post-radiotherapy. However, early radiation-induced cardiotoxicity diagnosis should be a priority throughout the treatment process, requiring further studies with a larger sample size and a longer follow-up to find valuable tools to minimize the side effects of therapeutic manipulations.

Introduction: The Ligasure small jaw (LISJ) is believed to provide several benefits for thyroid surgery. The use of LISJ by non-expert surgeons or those who erroneously assume its extensive usage can reduce postoperative bleeding may, in reality, pose a considerable risk of additional severe consequences.

Material and methodology: Between March and December of 2022, I analyzed complications following total thyroidectomy (TTH) case series for 10 patients who underwent surgery for papillary thyroid cancer by one qualified surgeon using LISJ. Cohorts were evaluated prospectively including hypocalcemia (HC) and recurrent laryngeal nerve (RLND) palsy.

Results: All 10 patients experienced postoperative hypocalcemia (HC), necessitating a postoperative calcium supplement with vitamin D. One patient suffered stridor after extubation.

Conclusion: The Ligasure Small Jaw serves as an effective hemostatic device, but it requires more attention in complete thyroidectomy. During a complete thyroidectomy, the Ligasure Small Jaw's lateral heating action may affect delicate structures more often than reported. Such damage could lead to hypocalcemia, which could be temporary or permanent, and recurrent laryngeal nerve palsy. More research would provide greater insights into the anticipated complication rates, particularly when conducted by less experienced specialized surgeons.

Background: The quality of methodological reporting of randomised controlled trials (RCTs) is an important consideration in the use of RCTs for guiding healthcare decisions; however, in recent years, the quality of reporting has been examined from a more methodological perspective. The current study seeks to compare the methodological reporting of randomized controlled trial (RCT) articles published in Iranian nursing and midwifery journals indexed in Scopus with that of RCT articles published in nursing and midwifery journals indexed in the Scopus database, utilizing the CONSORT checklist as a framework for evaluation.

Method: The current study is a comparative cross-sectional study. RCT articles from eight Iranian Scopus-indexed journals (381 articles) and three of the journals with the highest CiteScore index (204 articles) were reviewed. The study was conducted during 2017-2021. The data collection utilized the methodology section of the CONSORT checklist, which comprises 17 items and incorporates a two-dimensional scoring system with a score range of 0 to 17. SPSS 19 software was used for data analysis.

Results: The average percentages of the methodological reports published in the top three Iranian journals, indexed in the Scopus, were 76.4% and 84.4%, respectively. Also, the mean quality score of methodological reporting of RCT articles published in Iranian nursing and midwifery journals was significantly lower than the mean score of methodological reporting of RCT articles in international nursing and midwifery journals indexed in the Scopus published from 2017-2021 (P <0.001). In some cases, such as items related to randomisation and blinding, there was under-reporting in both groups of journals.

Conclusion: The results of the research showed that the average quality of the methodological report in most cases of CONSORT statements in Iranian journals is lower than that of the top three Scopus journals. Journals with lower reporting quality scores, such as Iranian journals, can improve the quality of their articles by following reporting guidelines for all types of articles, including RCT articles.

This comprehensive review explores the multifaceted landscape of preclinical drug development, encompassing crucial stages, regulatory intricacies, Investigational New Drug (IND) submissions, and innovative formulation strategies. Delving into preclinical studies, the review underscores the importance of pharmacokinetics, pharmacodynamics, and safety assessments in animal models. Regulatory requirements governing preclinical studies are dissected, emphasizing compliance with global health authorities. The article provides a detailed examination of the IND submission process, elucidating essential components and documentation required for regulatory approval that are pivotal for advancing to clinical trials. Additionally, the evolving realm of Preformulation strategies is scrutinized, highlighting new methods like nanotechnology, solid dispersions, and formulas based on cyclodextrin to enhance drug solubility, stability, and bioavailability. This comprehensive overview aims to guide researchers, pharmaceutical professionals, and regulatory specialists through the complexities of preclinical development, offering insights into the latest formulation advancements from a legal point of view, making it be easy for potential drugs to go from lab to patient's bedside.

Rapid healthcare digitization has created both previously unheard-of potential and serious data management weaknesses, especially in clinical trials. Artificial Intelligence (AI) offers innovative approaches to enhancing cybersecurity and ensuring legal compliance in healthcare systems. Protecting private information from internet threats is more crucial than ever because clinical trials are increasingly reliant on patient data, electronic health records, and realtime monitoring devices. This study reviews how AI might strengthen cybersecurity procedures in clinical trial setups. Data breaches and unauthorized access are significantly reduced when AIdriven technologies are used for real-time threat detection and response. These systems create a dynamic defense mechanism that traditional security measures lack by continuously adapting to changing cyber threats using machine learning algorithms. In addition to cybersecurity, AI improves adherence to healthcare laws like GDPR and HIPAA by automating data processing procedures. AI protects patient confidentiality and data integrity by ensuring that clinical trials follow stringent regulatory criteria through intelligent automation. Additionally, AI helps detect and control compliance issues, relieving human monitoring and boosting productivity. Additionally, the study addresses the difficulties in applying AI in clinical trials, including the requirement for transparent algorithms and the possibility of bias in AI judgment. However, AI has the capacity to completely transform safe healthcare administration with the correct legislation and ethical guidelines. In conclusion, artificial intelligence (AI) is a vital tool for guaranteeing the confidentiality and legal compliance of medical data in addition to using it to increase clinical trial efficiency. The use of it offers a path forward in terms of the complexities of modern clinical trial cybersecurity. AI's automation and intelligence will lower risk and increase trial speed and accuracy by assisting clinical trial administrators and sponsors in navigating the complicated world of cybersecurity and compliance.

Background: Chronic liver diseases are associated with impaired sex hormone metabolism and downregulation of the hypothalamic-pituitary-gonadal axis. Clinically, this may manifest as a variety of sexual disorders, such as erectile dysfunction, lower urinary tract symptoms, and even infertility. Psychological and mental disturbances associated with liver diseases aggravate sexual dysfunction even further. The existing gap in theoretical knowledge of pathophysiological mechanisms linking the above mentioned conditions explains the lack of attention to sexual health in this cohort of patients in a clinical setting.

Objectives: To review and analyze the latest available literature evidence on the possible pathophysiologial links and clinical associations of chronic liver diseases with sexual dysfunction in both sexes.

Methods: The PubMed database was searched using terms "chronic liver disease", "liver cirrhosis", "viral hepatitis B", "viral hepatitis C", "non-alcoholic fatty liver disease", "metabolic dysfunction-associated steatotic liver disease", "alcoholic liver disease" and "erectile dysfunction," "hypogonadism," "infertility". Articles published in the time period between January 1995 and December 2024 were reviewed.

Results: A total of 100 articles were reviewed, represented by preclinical original research articles, human observational and clinical studies, as well as meta-analyses relating chronic liver diseases to the development and progression of erectile dysfunction, hypogonadism, and infertility in males and females.

Conclusions: Chronic liver diseases are associated with a vast variety of sexual dysfunctions in both sexes. Erectile dysfunction is most commonly present and is possibly reversible following antiviral therapy or liver transplantation. The strengths of the association found between liver diseases and sexual dysfunction dictate the need to develop new diagnostic and therapeutic approaches in such patients.

The use of antibodies to neutralize cytotoxic soluble amyloid-β aggregates rather than remove plaque has raised cautious hope since the monoclonal antibody BAN2401 seems to halt the course of prodromal Alzheimer's Disease (AD). By immobilizing cytotoxic amyloid-β, rather than the causative factor, plaques can help prevent Alzheimer's disease. A preventive immunity against Alzheimer's disease is shown by natural antibodies against cytotoxic amyloid-β. Vaccines should include adjuvants that promote anti-inflammatory Th2 immunity and immunogens that guard against different cytotoxic amyloid-β conformers to prevent or delay the onsetof Alzheimer's disease. The lack of long-term protection with monoclonal antibodies that neutralize single conformers, such as aducanumab, may be due to amyloid-β pleomorphism. In this scenario, novel cytotoxic conformers might evade neutralization by monoclonal antibodies that were previously successful. A vaccine's ability to elicit a polarized Th2 immunity would depend on both priming and the simultaneous delivery of immunogen to dendritic cells. In addition to neutralizing antibodies against neurotoxic amyloid-β oligomers, an immune response may also release anti-inflammatory cytokines, which can help prevent inflammation that exacerbates Alzheimer's disease. Vaccines would be significantly more successful in preventing Alzheimer's disease than treating it because of age-related immunological decrease. Since both amyloid-β and tau contribute to pathological hyperphosphorylation and work in tandem to cause Alzheimer's disease, preventive vaccinations against both should be taken into consideration. Given their affordability and simplicity, vaccines may be the only way to stop the looming Alzheimer's pandemic in many nations.

Polycystic Ovary Syndrome (PCOS) is a highly prevalent endocrine disorder that affects women of reproductive age. PCOS is further correlated with infertility, menstrual dysfunction, and hyperandrogenism. Despite the advanced understanding of reproductive biology, the exact causes of PCOS remain ambiguous. Nevertheless, several factors are believed to contribute to the development of PCOS, including insulin resistance, hyperinsulinemia, obesity, and genetic predispositions. The diagnosis of PCOS is complicated by its phenotypic heterogeneity, which manifests differently in different individuals. Presently, the therapeutic management of PCOS-afflicted infertility depends upon proper pharmaceutical-based therapies aimed at treating underlying symptoms, such as the use of clomiphene citrate, metformin, ovulation-inducing agents, anti-androgens, exogenous gonadotropin administration, laparoscopic ovarian drilling, and in vitro fertilization. The present review focuses on narrating present therapeutic interventions along with lifestyle modifications in PCOS. Furthermore, it focuses on the ongoing clinical trials of various chemotherapeutics to counter PCOS-induced infertility among women.