Reviews on recent clinical trials最新文献

Traditional Iranian medicine is usually used for both prevention and relief of cold and flu symptoms in China, Iran, and many other Asian countries all over the world. There are 4 kinds of influenza viruses. Unlike type B, which may cause seasonal epidemics, type A viruses can cause pandemics, and influenza C may lead to mild human infection with little public health effects. A literature review was done by using multiple databases such as ISI Web of knowledge, PubMed, Science Direct and Google Scholar. The most notable antiviral medicinal plants for flu and cold are honeysuckle flowers, thyme leaf, green chiretta, andrographis, peppermint oil and leaf and calendula. The most important expectorant medicinal plants for cold and flu are snake root, tulsi, licorice root, slippery elm, clove, and sage leaf. Recommended immunostimulant medicinal plants for cold and flu are eucalyptus, Echinacea root, ginseng, garlic, slippery elm, marshmallow, Usnea lichen, Isatis root, ginger root, and myrrh resin. Iranian traditional medicine, which is one of the oldest schools of traditional medicine, is one of the main concepts of disease and health, and it can be considered as an important complementary and alternative medicine, as in some cases, modern medicine has many side effects, low efficiency, and high costs. Medicinal plants and herbs, which are included in many traditional systems, have significant and promising bioactive components in organic life.

Introduction: Prolactinomas are the most common type of pituitary gland tumors that secrete overly prolactin. They account for approximately 60% of all hormone-secreting hypophysis tumors.

Aim: This study aims to analyze gender differences in patients with prolactinomas who were operated on transsphenoidal surgery and conduct a single-center retrospective analysis of patient data.

Material and methods: This study evaluated the medical records of 109 patients (61 females and 48 males) from 2009 to 2019 at Feofaniya Clinical Hospital of the State Administration of Affairs in Kyiv, Ukraine. The primary criterion for including patients was a Serum Prolactin (PRL) level of over 100 ng/ml and the presence of a pituitary adenoma (PA) as observed on MRI. Additionally, the histological examination needed to confirm the presence of Prolactin-Secreting Pituitary Adenomas (PSPAs) without plurihormonal activity through both microscopy and immunohistochemical (IHC) staining.

Results: Significant differences in preoperative PRL levels were not observed. However, males had significantly larger tumor sizes and prevalence of macroadenomas. In male patients, the preoperative PLR levels showed a weak negative correlation with age (r=-0.304, p < 0.036) and a positive correlation with tumor size (r=0.555, p < 0.001) and cavernous sinus invasion (r=0.339, p < 0.018). In females, preoperative PRL was significantly associated only with tumor size and Knosp grade.

Conclusion: Prolactin-Secreting Pituitary Adenomas (PSPAs) are more common in women than men and are characterized by larger and more invasive tumors with high PRL levels at diagnosis. The PRL level and tumor size before surgery can predict early biochemical remission in both males and females with an accuracy of 58.3% and 68.8%, respectively.

Background: Most of the mortality after Heart Transplantation (HT) is attributed to severe cardiac allograft vasculopathy (CAV) and rejection.

Objectives: This meta-analysis aimed to investigate the effects of postoperative statin therapy on outcomes (mortality, rejection, and CAV in HT patients).

Methods: This systematic review and meta-analysis was performed on publications between 1980 and October 2023 in Web of Science, Scopus, PubMed, Cochrane, Science Direct, Google Scholar, and Embase databases. Heterogeneity was assessed using Chi-square, I2, and forest plots. Publication bias was evaluated using Begg's and Egger's tests. Analyses were performed in Stata 15 with significance at p < 0.05.

Results: This meta-analysis included 17 studies comprising 4,627 participants and conducted between 1995 to 2021. Compared to non-users, the odds of mortality were lower among statin users (OR= 0.49, 95% CI: 0.32-0.75, p < 0.001). The odds of CAV were also reduced with statin use (OR= 0.71, 95% CI: 0.53-0.96, p = 0.027). The odds of rejection were not significantly different (OR= 0.69, 95% CI: 0.41-1.15, p = 0.152). However, rejection odds were lower with statins in RCTs (OR= 0.42, 95% CI: 0.21-0.82, p = 0.012) but not in case-control studies (OR= 0.87, 95% CI: 0.49-1.52, p = 0.615). No publication bias was observed with Begg's test, but Egger's test showed possible bias.

Conclusion: This meta-analysis found postoperative statin use associated with lower mortality and CAV, but not overall rejection, though RCT subgroup analysis showed decreased rejection with statins. Statin therapy may improve prognosis in HT patients.

The Middle east and North Africa harbour many native species with pharmaceutical and nutraceutical potential. Since the beginning of history, food and herbal medicinal plants have been an essential part of human lives and the traditional Middle Eastern healthcare system. The notable medicinal plants that have been mentioned in the Bible, which are common in West Asia and some regions of North Africa, are Aloe vera, anise, balm, cassia, cinnamon, cumin, flax, and fig. Chemical components of Aloe vera are aloin, sinapinic acid, catechin, chromone, myricetin, quercitrin and syringic acid. Anethole, safrole, and estragole are the main chemical components of anise. The chemical components of cassia are coumarin, emodin, cinnamyl alcohol, and cinnamaldehyde. The major chemical ingredients of cumin are terpinene, cuminaldehyde, sabinene, thujene, and thymoquinone. The goal of this article is to review the considerable health benefits and pharmaceutical benefits of medicinal herbs and plants that have been neglected and underutilized in the Middle East and North Africa, as well as to promote their utilization. On the basis of the results, the experimented neglected medicinal plant can offer various advantages when used together with conventional medicinal treatments for various health conditions, such as palliative care in managing the side effects of conventional treatments, access to a wider range of treatments, increased patient satisfaction, and improved emotional and mental well-being. Moreover, consuming medicinal plants may help to manage and prevent diabetes, cancer, and heart disease with notable anti-tumor, and anti-inflammatory properties.

The recently approved immunotherapeutic drugs are Keytruda (pembrolizumab) and Imfinzi (durvalumab) for advanced biliary tract cancers that inhibit PD-1 receptor and PD-L1 ligand, respectively. In this perspective, the results of the two clinical trials, i.e., TOPAZ-1 (NCT03875235) and KEYNOTE-966 (NCT04003636), are critically appraised, compared, and discussed to assess the benefits of these two drugs in the context of the treatment of advanced biliary tract cancers with a focus on PD-L1 status and MIS (microsatellite instability) status and therapy responsiveness in the subgroups. Analyzing the PD-L2 status in biliary tract cancer patients can aid in assessing the prognostic value of PD-L2 expression in determining the clinical response and this may aid in appropriate patient stratification.

The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.

Background: Hairy cell leukemia commonly presents with pancytopenia, indolent course, and predisposition as infectious complications. Current first-line therapeutic options are purine analogues, particularly cladribine, with a high percentage of complete responses and durable remissions. However, their use is poorly investigated in patients affected by severe chronic renal insufficiency.

Case presentation: Here, we describe a case of HCL in a 68-year-old man affected by multiple comorbidities, including severe chronic renal failure. After a course of interferon-α, the patient received therapy with Cladribine every other week, obtaining a complete hematological remission and improvement of renal function.

Discussion: With a different soft schedule of cladribine, the patient was treated adequately, obtaining a complete remission.

Conclusion: Cladribine can be administered with caution, even in patients with renal failure, with good results.

Background: There has been a concern about the quality of clinical trials conducted in terms of data integrity, accuracy or ethical conduct. This study aimed to assess the tangible gap existing in knowledge and application of rules and guidelines among the Researcher, Research staff (RS) and Ethics Committee (EC) members - the three research stakeholders at the study sites.

Methods: A validated e-questionnaire with details for demography, role, years of experience, affiliation and questions on knowledge and understanding about their clinical research functions based on the New Drugs and Clinical Trials (NDCT) Rules 2019, including: 'Role and responsibility, Regulations, Reporting timelines, Documentation, Conflict of interest and Miscellaneous' was circulated among the seven research sites of one organization with their fourteen Institutional ECs, as part of planned annual survey. Responses with >60% correct answers were arbitrarily considered to represent adequate knowledge.

Results: Of 201 participants, there were 27.4% Researchers, 50.2% were from the EC and 22.4% RS. A greater proportion of the Researchers (43.6%) had >5 years of experience. The mean ± SD of correct answers obtained was 66.9 ± 14.77 and was statistically significant (p<0.05) among the groups, highest for the EC members (71.4 ± 11.51), those with 2-5 years of experience (68.4 ± 14.40), and least for the RS (56.8 ± 11.93). Researchers (> 90%) were aware of their role in the clinical trial agreement and the importance of the trial registration in the Clinical Trials Registry India. There were gaps in the knowledge on Informed Consent (IC) process and post-trial access. Awareness regarding the IC process was adequate among the RS (84%). Awareness that the responsibility of all delegation at the site finally lies with the Researchers was adequate (60%), but 20% incorrectly believed that the sponsor can have access to subject identification details. Deficiencies were noted regarding documentation, NDCT rules -2019 and serious adverse event (SAE) reporting process. Five percent answered that Data Clarification Forms were generated after reviewing the case report forms. The awareness that NDCT rules-2019 was not for medical devices, student projects or Investigator Initiated Studies was inadequate (56%). The EC members' awareness of roles and responsibilities was adequate (≥ 90%). Knowledge gaps were noted in EC monitoring of the ongoing trials (32%) and SAE reporting on the SUGAM portal (8.8%), where stakeholders can access the regulator's web services using a single window interface for clinical trial related activities.

Conclusion: There are gaps in the knowledge of the 3 stakeholders at the site. Identifying and rectifying the gray areas will improve the site's performance. There is a need for regular training and assessments.