Reviews on recent clinical trials最新文献

Purpose: SARS-CoV-2 infection has been associated with the impairment of several organs, including the liver. In addition, cases of autoimmune hepatitis have been described in association with COVID-19 disease. According to some case reports, vaccination has also been suggested to elicit the immune liver disorder.

Case description: We report on the case series of two middle-aged women developing COVID-19 infection despite a completed vaccination schedule. More interestingly, the infection was followed by the onset of acute hepatitis with a significant increase in the values of liver function tests (x 10 normal values). After ruling out the main causes of liver damage (viral, toxic, etc.), a diagnosis of autoimmune hepatitis was made and supported by liver histology in both cases. The clinical picture was quickly reverted with immunosuppressive (steroid) therapy, also confirming the diagnosis.

Conclusion: We observed a possible relationship between COVID-19 infection and the onset of autoimmune hepatitis and also described this occurrence in vaccinated subjects. It remains to be clarified whether repeated exposure to viral antigens (vaccination plus true infection) or specific emerging viral genotype (omicron strain) may facilitate the onset of this immune liver disease.

Objective: This study aimed to assess the efficacy and safety of anti-VEGF combined with dexamethasone implant for the retinal vein occlusion patients with macular edema.

Methods: In this prospective, case-controlled, cohort clinical trial (Register ID: ChiCTR2400080048), patients with non-ischemic retinal vein occlusion were enrolled from the Sanmenxia Central Hospital from August 2020 to April 2023. The patients were randomized into two groups. All the patients received ranibizumab intravitreal injection in the first 3 consecutive months. For the ranibizumab group, anti-VEGF injections were as needed thereafter in case of recurrence of macular edema; For the combination group, the patients received an intravitreal dexamethasone implant injection at 15 days after the first ranibizumab injection. The primary outcome measurements were improvement in best corrected visual acuity (BCVA) and reduction in central macular thickness (CMT). The secondary outcomes were recurrence of macular edema, number of intravitreal injections, and injection interval. Safety profiles were also recorded.

Results: A total of 124 patients were included, of which 73 patients completed all follow-ups. Both the ranibizumab monotherapy and the combination therapy significantly improved BCVA at all time points, compared to the baseline. The combined group achieved more BCVA improvement in 3 months, 6 months, and 12 months, compared to the ranibizumab alone group. Compared to the baseline, both groups achieved significant reductions in CMT at all follow-ups. However, the combination group showed more CMT reduction at 1 week post injection, compared to the ranibizumab group. The combination group had a significantly longer injection interval, lower injection time, and recurrence of macular edema. Ocular hypertension was the most common adverse events. Lastly, intraocular pressure was all well controlled by 1-3 glaucoma medications without surgical intervention.

Conclusion: The combination therapy could significantly improve the BCVA and reduce the CMT with a good safety profile.

Background: Colorectal carcinoma (CRC) is one of the most common malignancies in the Western world, and metastatic disease is associated with a dismal prognosis. Poly-ADpribose polymerase (PARP) inhibitors gain increasing attention in the field of medical oncology, as they lead to synthetic lethality in malignancies with preexisting alterations in the DNA damage repair (DDR) pathway. As those alterations are frequently seen in CRC, a targeted approach through PARP inhibitors is expected to benefit these patients, both alone and in combination with other agents like chemotherapy, immunotherapy, antiangiogenics, and radiation.

Objective: This review article aims to better clarify the role of PARP inhibitors as a treatment option in patients with metastatic CRC with alterations in the DDR pathway.

Methods: We used the PubMed database to retrieve journal articles and the inclusion criteria were all human studies that illustrated the effective role of PARP inhibitors in patients with metastatic CRC with homologous repair deficiency (HRD) and the correct line of therapy.

Results: Current evidence supports the utilization of PARP inhibitors in CRC subgroups, as monotherapy and in combination with other agents. Up to now, data are insufficient to support a formal indication, and further research is needed.

Conclusion: Efforts to precisely define the homologous repair deficiency (HRD) in CRC - and eventually the subgroup of patients that are expected to benefit the most - are also underway.

Finasteride and dutasteride are 5a Reductase Inhibitors (5a-RIs) and comprise the mainstay of treatment for the management of patients with benign prostatic hyperplasia. 5a-RIs are expressed in a variety of tissues, such as adipose tissues and liver, resulting in a reduction of glucocorticoid levels and affecting androgen regulation and metabolic function. As a result, the administration of these regimens may generate adverse metabolic events, such as liver disease, hyperglycemia, hyperlipidemia, and diabetes mellitus. Although several studies have tried to record these adverse metabolic events both in human subjects and animal models, the exact mechanisms of these actions have not been well described yet in the literature. Further well-designed clinical trials are needed to elucidate the exact role of 5a reductase inhibitors in the progression of the metabolic syndrome. The aim of this study was to systematically review the literature concerning the role of dutasteride or finasteride in the progression of metabolic adverse events and further investigate possible pathophysiologic mechanisms.

Confidence interval (CI) is one of the important reporting tools for research data as it not only provides valuable information about the effect size along with its width but also possible clinical significance. Unfortunately, this approach is not being utilized to its fullest extent. Determining point estimate always includes an element of uncertainty due to associated sampling error. A confidence interval may be an appropriate tool to measure this uncertainty. Further, the P value does not convey information about the magnitude of an effect and the error associated with it. Thus, in an ideal situation effect size should preferably be associated with a confidence interval to assess precision. Not only does CI let us assess likely effects but also decides whether the intervention applied could have clinical utility. In contrast, the p-value limits our option to either reject any differences that are not significant or accept those that are. However, confidence intervals are commonly misinterpreted. It is imperative to understand that the CI is not the range of effects that 95% of patients in the population exhibit. Moreover, it would also be erroneous to say that there is a 95% probability that the CI includes the true population effect. Interpretation is usually based on the context in which the confidence interval is being looked at. From a utility point of view and like other statistical tools confidence interval approach does have several advantages as well as disadvantages and is far beyond being a perfect statistical tool.

Background: Solid organ transplantation is a life-saving medical operation that has progressed greatly because of developments in diagnostic tools and histocompatibility tests. Crossmatching for complement-dependent cytotoxicity (CDC) and human leukocyte antigen (HLA) typing are two important methods for checking graft compatibility and reducing the risk of graft rejection. HLA typing and CDC crossmatching are critical in kidney, heart, lung, liver, pancreas, intestine, and multi-organ transplantation.

Methods: A systematic literature search was conducted on the internet, using PubMed, Scopus, and Google Scholar databases, to identify peer-reviewed publications about solid organ transplants, HLA typing, and CDC crossmatching.

Conclusion: Recent advances in HLA typing have allowed for high-resolution evaluation, epitope matching, and personalized therapy methods. Genomic profiling, next-generation sequencing, and artificial intelligence have improved HLA typing precision, resulting in better patient outcomes. Artificial intelligence (AI) driven virtual crossmatching and predictive algorithms have eliminated the requirement for physical crossmatching in the context of CDC crossmatching, boosting organ allocation and transplant efficiency. This review elaborates on the importance of HLA typing and CDC crossmatching in solid organ transplantation.

Introduction: Intrinsically Disordered Proteins (IDPs) are active in different cellular procedures like ordered assembly of chromatin and ribosomes, interaction with membrane, protein, and ligand binding, molecular recognition, binding, and transportation via nuclear pores, microfilaments and microtubules process and disassembly, protein functions, RNA chaperone, and nucleic acid binding, modulation of the central dogma, cell cycle, and other cellular activities, post-translational qualification and substitute splicing, and flexible entropic linker and management of signaling pathways.

Methods: The intrinsic disorder is a precise structural characteristic that permits IDPs/IDPRs to be involved in both one-to-many and many-to-one signaling. IDPs/IDPRs also exert some dynamical and structural ordering, being much less constrained in their activities than folded proteins. Nuclear magnetic resonance (NMR) spectroscopy is a major technique for the characterization of IDPs, and it can be used for dynamic and structural studies of IDPs.

Results and conclusion: This review was carried out to discuss intrinsically disordered proteins and their different goals, as well as the importance and effectiveness of NMR in characterizing intrinsically disordered proteins in healthy and diseased states.

Carob (Ceratonia siliqua L.) has been widely cultivated in different parts of the world, particularly in the Mediterranean region, and the tree belongs to the family Leguminosae. Several studies have indicated that carobs and their products can improve human health and help prevent different specific chronic diseases. Carob can considered as functional food due to its high content in dietary fibers, low-fat content, and high content of minerals. Its fruit is a pod containing 10%-20% seeds, and the pods consist of sugars, proteins, crude fibers, minerals, vitamins, polyphenols, vitamins, and lipids. In many countries in the Middle east, carob is mainly used to prepare as a traditional drink and some kinds of confectioneries. The powders can be utilized to prepare carob juice concentrate. The systematic review of documents from clinical trials and scientific societies dedicated to traditional medicine in China has been carried out. The goal of this review article is a survey of chemical compounds, and pharmaceutical benefits of carob, especially by considering traditional medicinal sciences. Moreover, clinical trials research promotes studies to highlight and focus on the scope of application of traditional medicinal science in the growing system of medicine.

Aim: The purpose of the present study was to determine cancer patients' attitudes toward the anti-COVID-19 vaccine.

Background: Historically, the scientific community's responsibility was to investigate attitudes about vaccination. The course of COVID-19 in cancer patients makes them a high priority for vaccination. Cancer patients are at greater risk of serious complications and death because of COVID-19 infection.

Objective: The purpose of the present study was to determine cancer patients' attitudes toward the anti-COVID-19 vaccine. We examined several constructs that potentially influenced cancer patients' perceptions of the vaccine: health status, knowledge of COVID-19 and vaccination, cancer patients' perceptions of vulnerability, and attitudes toward general vaccines.

Methods: We conducted a collective case study with 200 cancer patients undergoing treatment, and divided the sample into two groups: patients who "expected to heal" (Group A) and patients who "expected to chronicize" (Group B). Data were collected through a purpose-built questionnaire consisting of 22 questions and a study of medical records.

Results: Data analysis showed that both groups, Group A (M= 3.89 SD= 0.64) and Group B (M= 3.98 SD= 0.64), had a favorable attitude toward the anti-COVID-19 vaccine. This favorable attitude toward the anti-COVID-19 vaccine depended on several factors: perception of vulnerability to COVID-19, perception of the severity of their oncological situation, and communication with oncologists.

Conclusion: Our study highlighted the plurality of factors that influence attitudes toward the anti-COVID-19 vaccine. It is therefore of fundamental importance to increase the use of the shared decision-making approach (SDM) to guide the patient to an informed choice.