Reviews on recent clinical trials最新文献

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.

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.

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 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: Metastatic castrate-resistant prostate cancer (mCRPC) is a challenging disease, especially in heavily pretreated patients. Androgen pathway inhibitors have contributed to a notable improvement in the overall survival and quality of life in patients with mCRPC during the last decade. Still, a considerable percentage of patients are unable to draw benefits from this drug category and are deprived of a treatment that offers limited toxicity and preserves a good quality of life. The mechanisms leading to this pre-existing or acquired resistance, as well as the possible strategies to overcome this resistance have been put at the center of scientists' attention.

Case presentation: With the present report we present the case of a 70-year-old patient with mCRPC, who was apparently an enzalutamide non-responder, but a multimodal approach with enzalutamide continuation and irradiation to his symptomatic oligoprogressive disease converted him to a responder with clinical, biochemical and imaging response; furthermore, we discuss the existing data providing evidence for the use of metastasis-directed therapy in combination with androgen pathway inhibitors in order to overcome drug resistance in patients with oligoprogressive disease.

Conclusion: A considerable proportion of patients with oligometastatic or oligoprogressive prostate cancer who seem not to respond to androgen pathway inhibitors, such as enzalutamide, due to preexisting or acquired resistance, could benefit from MDT with a multimodal treatment approach. This strategy allows androgen pathway inhibitor continuation beyond biochemical progression and delays the switch to next-line systemic treatment.