Search results for "Trials"

The hard road to data interpretation: 3 or 6 months of adjuvant chemotherapy for patients with stage III colon cancer?

2019

Background Six months of adjuvant oxaliplatin-based chemotherapy is standard for patients with stage III colon cancer following surgery. However, oxaliplatin is associated with peripheral neurotoxicity which worsens over treatment duration. Consequently, a shorter treatment duration, if equally effective, would be extremely beneficial. A pooled analysis of data for 12 834 stage III colon cancer patients, from six randomised phase III trials of adjuvant therapy, the International Duration Evaluation of Adjuvant chemotherapy study, was carried out and the results presented at the ASCO Annual Meeting 2017. To clarify the potential impact of these results on clinical practice, ESMO decided to s…

Safety of red yeast rice supplementation: A systematic review and meta-analysis of randomized controlled trials.

2019

International audience; Recently, concerns regarding the safety of red yeast rice (RYR) have been raised after the publication of some case reports claiming toxicity. Since the previous meta-analyses on the effects of RYR were mainly focused on its efficacy to improve lipid profile and other cardiovascular parameters, we carried out a meta-analysis on safety data derived from the available randomized controlled clinical trials (RCTs). Primary outcomes were musculoskeletal disorders (MuD). Secondary outcomes were non-musculoskeletal adverse events (Non-MuD) and serious adverse events (SAE). Subgroups analyses were carried out considering the intervention (RYR alone or in association with oth…

Virotherapy in Germany—Recent Activities in Virus Engineering, Preclinical Development, and Clinical Studies

2021

Virotherapy research involves the development, exploration, and application of oncolytic viruses that combine direct killing of cancer cells by viral infection, replication, and spread (oncolysis) with indirect killing by induction of anti-tumor immune responses. Oncolytic viruses can also be engineered to genetically deliver therapeutic proteins for direct or indirect cancer cell killing. In this review—as part of the special edition on “State-of-the-Art Viral Vector Gene Therapy in Germany”—the German community of virotherapists provides an overview of their recent research activities that cover endeavors from screening and engineering viruses as oncolytic cancer therapeutics to their cli…

Efficacy of Chondroitin Sulfate in Patients with Knee Osteoarthritis: A Comprehensive Meta-Analysis Exploring Inconsistencies in Randomized, Placebo-…

2019

Introduction There are some controversies about treatment modalities in osteoarthritis (OA), including chondroitin sulfate (CS). The objective of this study was to determine whether CS is effective at alleviating pain and improving function in patients with knee OA and to identify the factors that explain inconsistencies in clinical trial results. Methods We conducted a systematic review of randomized, placebo-controlled trials, searching the databases Medline, Cochrane central register for controlled trials and Scopus. Random effects meta-analysis was then performed, using tau2 and I2 statistics to assess heterogeneity. The pain and Lequesne index (LI) scores were expressed as standardized…

Preferred Outcome Measures Used in Randomized Clinical Trials of Total Knee Replacement Rehabilitation: A Systematic Review.

2020

Objective To determine the most frequently used outcome measures in total knee replacement rehabilitation trials. Literature survey Systematic review of randomized trials searched in five databases: Web of Science, MEDical Literature Analysis and Retrieval System, Physiotherapy Evidence Database, Scopus, and Cochrane Library. Methodology Trials were included if participants underwent total knee replacement rehabilitation and outcome measures were used to assess rehabilitation outcomes. A descriptive synthesis determined the frequency of using outcome measures and preferred assessment time points. Outcomes were classified into eight categories: patient- and clinician-reported function, perfo…

Primera persona del plural en los juicios orales. Valor representativo y estrategia atenuante

2018

El objetivo de este artículo es doble, pues nos proponemos estudiar los valores que puede desarrollar la primera persona del plural en los juicios orales y, en relación con ello, examinar si es posible identificar usos atenuantes asociados a este mecanismo referencial. Tras analizar nuestro corpus siguiendo una metodología cualitativa y cuantitativa, hemos podido observar que el uso de la primera persona del plural en este género no solo se debe al carácter representativo del sistema legal español o a las imposiciones de la tradición discursiva. Frecuentemente, el uso de la primera persona del plural (especialmente el plural de modestia y el plural sociativo) codifica un valor atenuante ori…

Anaesthesia protocol evaluation of the videolaryngoscopy with the McGrath MAC and direct laryngoscopy for tracheal intubation in 1000 patients underg…

2021

IntroductionRapid sequence induction of anaesthesia is indicated in patients with an increased risk of pulmonary aspiration. The main objective of the technique is to reduce the critical time period between loss of airway protective reflexes and rapid inflation of the cuff of the endotracheal tube to minimise the chance of aspiration of gastric contents. The COVID-19 pandemic has reinforced the importance of first-pass intubation success to ensure patient and healthcare worker safety. The aim of this study is to compare the first-pass intubation success rate (FPS) using the videolaryngoscopy compared with conventional direct laryngoscopy in surgical patients with a high risk of pulmonary as…

An expression of concern on research during the Covid-19 pandemic

2020

Widening use of dexamethasone implant for the treatment of macular edema

2017

Vincenza Bonfiglio, Michele Reibaldi, Matteo Fallico, Andrea Russo, Alessandra Pizzo, Stefano Fichera, Carlo Rapisarda, Iacopo Macchi, Teresio Avitabile, Antonio Longo Department of Ophthalmology, University of Catania, Catania, Italy Abstract: Sustained-release intravitreal 0.7 mg dexamethasone (DEX) implant is approved in Europe for the treatment of macular edema related to diabetic retinopathy, branch retinal vein occlusion, central retinal vein occlusion, and non-infectious uveitis. The implant is formulated in a biodegradable copolymer to release the active ingredient within the vitreous chamber for up to 6 months after an intravitreal injection, allowing a prolonged interval of effica…

Safety Evaluation of α-Lipoic Acid Supplementation: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Clinical Studies

2020

Alpha-lipoic acid (ALA) is a natural short-chain fatty acid that has attracted great attention in recent years as an antioxidant molecule. However, some concerns have been recently raised regarding its safety profile. To address the issue, we aimed to assess ALA safety profile through a systematic review of the literature and a meta-analysis of the available randomized placebo-controlled clinical studies. The literature search included EMBASE, PubMed Medline, SCOPUS, Google Scholar, and ISI Web of Science by Clarivate databases up to 15th August 2020. Data were pooled from 71 clinical studies, comprising 155 treatment arms, which included 4749 subjects with 2558 subjects treated with ALA an…