Reviews on recent clinical trials最新文献

{"title":"A Systematic Review and Meta-Analysis of the Effects of Statin Therapy on Heart Transplantation.","authors":"Hossein Mardani-Nafchi, Seyed Mahmoud Reza Hashemi Rafsanjani, Saeid Heidari-Soureshjani, Saber Abbaszadeh, Babak Gholamine, Nasrollah Naghdi","doi":"10.2174/0115748871301446240513093612","DOIUrl":"10.2174/0115748871301446240513093612","url":null,"abstract":"<p><strong>Background: </strong>Most of the mortality after Heart Transplantation (HT) is attributed to severe cardiac allograft vasculopathy (CAV) and rejection.</p><p><strong>Objectives: </strong>This meta-analysis aimed to investigate the effects of postoperative statin therapy on outcomes (mortality, rejection, and CAV in HT patients).</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"256-266"},"PeriodicalIF":1.4,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141262650","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Power of the Underutilized and Neglected Medicinal Plants and Herbs of the Middle East.","authors":"Mohamad Hesam Shahrajabian, Wenli Sun","doi":"10.2174/0115748871276544240212105612","DOIUrl":"10.2174/0115748871276544240212105612","url":null,"abstract":"<p><p>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 <i>Aloe vera</i>, anise, balm, cassia, cinnamon, cumin, flax, and fig. Chemical components of <i>Aloe vera</i> 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.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"159-175"},"PeriodicalIF":1.4,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139973272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Inevitability Prospects of Regulatory Information Management Software RegDesk to Ease Regulation Approvals.","authors":"Animesh Ranjan, Dilpreet Singh","doi":"10.2174/0115748871254734230929201816","DOIUrl":"10.2174/0115748871254734230929201816","url":null,"abstract":"","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"4-6"},"PeriodicalIF":1.4,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41211038","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of Clinical Trial Results of the Recently Approved Immunotherapeutic Drugs for Advanced Biliary Tract Cancers.","authors":"Samayita Das","doi":"10.2174/0115748871276666240123043710","DOIUrl":"10.2174/0115748871276666240123043710","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"81-90"},"PeriodicalIF":1.4,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139576646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preface","authors":"L. Abenavoli","doi":"10.1109/CGIV.2005.60","DOIUrl":"https://doi.org/10.1109/CGIV.2005.60","url":null,"abstract":"<jats:sec>\u0000<jats:title />\u0000<jats:p />\u0000</jats:sec>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"1 1","pages":""},"PeriodicalIF":1.9,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1109/CGIV.2005.60","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46454015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.","authors":"Stéphane Vignot,&nbsp;Gaelle Guyader,&nbsp;Valérie Salomon,&nbsp;Philippe Vella,&nbsp;Isabelle Yoldjian,&nbsp;Patrick Maison,&nbsp;Christelle Ratignier-Carbonneil","doi":"10.2174/1574887118666230320124012","DOIUrl":"10.2174/1574887118666230320124012","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 3","pages":"167-171"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10514496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10205724","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cladribine Efficacy in a Patient with Hairy Cell Leukemia and Severe Renal Insufficiency.","authors":"Alessandro Gozzetti, Francesca Bacchiarri, Donatella Raspadori, Anna Sicuranza, Vincenzo Sammartano, Monica Bocchia","doi":"10.2174/0115748871241817230919062313","DOIUrl":"10.2174/0115748871241817230919062313","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Case presentation: </strong>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.</p><p><strong>Discussion: </strong>With a different soft schedule of cladribine, the patient was treated adequately, obtaining a complete remission.</p><p><strong>Conclusion: </strong>Cladribine can be administered with caution, even in patients with renal failure, with good results.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":" ","pages":"300-303"},"PeriodicalIF":1.4,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41111221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of Knowledge and Awareness Among the Stakeholders of Clinical Research at the Site: A Collaborative, Electronic-Survey Approach to Identify the Indicators of Quality.","authors":"Chandana Pal,&nbsp;Aravind Kumar Rengan,&nbsp;Latha Moodahadu,&nbsp;Jayanthi Swaminathan,&nbsp;Balakrishna Nagalla","doi":"10.2174/1574887118666221019100542","DOIUrl":"https://doi.org/10.2174/1574887118666221019100542","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"56-68"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9620908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cerebral Vasospasm: Practical Review of Diagnosis and Management.","authors":"Tatsiana Romenskaya,&nbsp;Yaroslava Longhitano,&nbsp;Fabio Piccolella,&nbsp;Jack Marshall Berger,&nbsp;Marco Artico,&nbsp;Samanta Taurone,&nbsp;Antonio Maconi,&nbsp;Angela Saviano,&nbsp;Michela Caramuta,&nbsp;Gabriele Savioli,&nbsp;Christian Zanza","doi":"10.2174/1574887117666220810121048","DOIUrl":"https://doi.org/10.2174/1574887117666220810121048","url":null,"abstract":"BACKGROUND\u0000Cerebral vasospasm is one of the frequent complications that can occur following subarachnoid hemorrhage (SAH). With new protocols in the management of SAH, the combined risk of death and long-term disability has been reduced by about 10% compared with the past.\u0000\u0000\u0000OBJECTIVE\u0000This work aims to report the latest updates on the vasospasm developing after the SAH in patients in the ICU department. In this short review, we reviewed the latest scientific findings on the mechanisms of vasospasm, and, in addition, we considered it necessary to review the literature to report the tools for early diagnosis of vasospasm and the best treatment strategies to prevent the negative outcome in patients admitted to ICU.\u0000\u0000\u0000SCOPE\u0000The aim of this narrative review is to report the main characteristics of vasospasm, new diagnostic methods and, especially, more effective treatment of vasospasm.\u0000\u0000\u0000MATERIALS AND METHODS\u0000The peer-reviewed articles analyzed were selected from PubMed, google scholar, Embase, Scopus databases in the previous 20 years and using the keywords words \"vasospam\", \"vasospasm diagnosis\", \"vasospasm and SAH\", \"vasospasm treatment\", non-traumatic brain injury. Among the 78 papers identified, 43 articles were selected; after title - abstract examination and removing the duplicates, only 31 articles were examined.\u0000\u0000\u0000RESULTS\u0000Vasospasm can be classified according to clinical (asymptomatic vs symptomatic) and diagnostic (angiographic vs ultrasound) methods. Various procedures such as TCD and CT perfusion are used for early diagnosis and close monitoring of this condition. The treatment of vasospasm consists of both prevention (nimodipine, statitis, magnesium sulphate) and active treatment (mainly endovascular).\u0000\u0000\u0000CONCLUSION\u0000As the review shows, vasospasm is a complication of SAH, a complication that is difficult to recognise early and treat with the best outcome. However, with the equipment we have, it has been possible to improve the outcome, even if it is still not ideal, of patients who develop vasospasm. Several studies are in the final stages to improve the outcome of this unfortunately frequent condition.","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"12-18"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9259262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Role of the Clinical Data Managers During the COVID-19 Pandemic: An Overview.","authors":"Rishitha Sajja","doi":"10.2174/1574887118666221208123724","DOIUrl":"https://doi.org/10.2174/1574887118666221208123724","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic has significantly changed the implementation of clinical trials. A large focus has been directed on clinical trial design, timeline, and best practices. It has led clinical trial study teams to update the existing processes and perform a risk assessment to mitigate the impact of the COVID-19 pandemic according to ICH-GCP (Good Clinical Practice) requirements. Data management plays a crucial role in understanding the study team's needs and developing innovative solutions. The Clinical Data Manager (CDM) is a core clinical trial Study Team member, responsible for promptly collecting, managing, and delivering complete, highquality data.</p><p><strong>Objective: </strong>The COVID-19 pandemic required the Clinical Data Manager (CDM) to respond to changing needs by adapting data collection tools, data review strategies, and data management processes to answer new questions and address new challenges. CDMs became responsible for identifying how the COVID-19 pandemic impacted current data management processes and documentation and implementing changes to reflect new ways of working. The present article reviews the impact of the COVID-19 pandemic on clinical trials and the solutions adopted by the Clinical Data manager.</p><p><strong>Conclusion: </strong>The collection of COVID-19-related data points provides a better understanding of patient safety during the pandemic and proactively fulfills the growing regulatory interests. Strategies and innovative solutions adopted by the Clinical Data Manager serve as guidance for the clinical research team during the crisis to make the trials more robust and patient-centered.</p>","PeriodicalId":21174,"journal":{"name":"Reviews on recent clinical trials","volume":"18 1","pages":"41-45"},"PeriodicalIF":1.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9266180","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}