Search results for "clinical trial"
showing 10 items of 1656 documents
Coronary Stent Thrombosis — Predictors and Prevention
2020
BACKGROUND: Stent thrombosis (ST) is a dreaded complication after stent implantation and is associated with a mortality between 5% and 45%. The mechanisms by which ST arises are complex. Because of the seriousness of this situation, all physicians should have at least basic knowledge of it. In this article, we present the risk factors for ST and discuss some innovative approaches to its treatment. METHODS: This review is based on pertinent articles retrieved by a selective search in PubMed, and on current international guidelines and expert recommendations. RESULTS: The frequency of ST has been markedly lowered by technical advances in coronary stenting and by the implementation of modern i…
Cost-efficacy of oral triptans in the treatment of acute migraine
2005
SummaryThe objective of this study was to compare the efficiency of oral triptans currently used in the treatment of acute migraine in Spain. Using a decision analytic model, a cost-efficacy analysis was performed from the payer's perspective. Efficacy was assessed in terms of sustained pain-free patients, with data extracted from a recent meta-analysis of clinical trials. Chest-related and central nervous system-related adverse events were also considered. For the economic analysis, the cost of drug treatment and the management of adverse events were determined.A group of three triptans (naratriptan 2.5 mg, sumatriptan 50 mg and almotriptan 12.5 mg) was found to dominate all other triptans…
Prognostic Factors in APL
2018
The prognosis of acute promyelocytic leukemia (APL) has significantly improved since the introduction of anthracyclines, but especially after the advent of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO). The identification of prognostic factors is a key process in clinical investigation, since their recognition allows the stratification of disease risks and promotes refined therapeutic adjustments. In fact, most treatments are now designed following risk-adapted strategies in order to optimize the therapeutic efficacy and minimizing side effects. The efficacy of treatment is one major determinant in prognosis. Therefore, the impact of a number of disease and patient characteristi…
Predictors of Early Death in Childhood Acute Promyelocytic Leukemia: Results of an International Retrospective Study
2015
Abstract Background: Acute promyelocytic leukemia (APL) is a rare subtype of childhood acute myeloid leukemia (AML). Bleeding complications occur in 80% of patients at diagnosis and contribute to a higher incidence of early death (ED) in APL compared to other AML subtypes. However, estimates of ED in pediatric APL are imprecise and factors associated with ED in children with APL are unknown. Objectives: To determine the incidence and predictors of ED, defined as death within 60 days from presentation, in childhood APL. Methods: We conducted a retrospective international analysis of children diagnosed with APL between January 1993 and December 2013. The study included 236 patients from the I…
Clinical results of transanal endoscopic microsurgery
1988
Using the "transanal endoscopic microsurgery" technique, 140 patients were treated at the Department of Surgery in Cologne and Mainz. Of the patients with adenomas, 68.2% had typical symptoms preoperatively. The postoperative hospital attendance was 8.7 days, with an average resection size of 14.4 cm2. The postoperative complication rate was 5%, and there were no deaths related to the technique. In a prospective controlled trial, 2.2% of the patients with adenomas treated endoscopically in Mainz showed recidivation, requiring reoperation. The follow-up rate was 100%. In 30 cases, microscopic examination revealed carcinoma. Radical reoperation in 8 pT1 tumours showed neither remaining tumour…
Multicenter Phase II Study of Lurbinectedin in BRCA-Mutated and Unselected Metastatic Advanced Breast Cancer and Biomarker Assessment Substudy
2018
Purpose This multicenter phase II trial evaluated lurbinectedin (PM01183), a selective inhibitor of active transcription of protein-coding genes, in patients with metastatic breast cancer. A unicenter translational substudy assessed potential mechanisms of lurbinectedin resistance. Patients and Methods Two arms were evaluated according to germline BRCA1/2 status: BRCA1/2 mutated (arm A; n = 54) and unselected ( BRCA1/2 wild-type or unknown status; arm B; n = 35). Lurbinectedin starting dose was a 7-mg flat dose and later, 3.5 mg/m2 in arm A. The primary end point was objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST). The translational substudy of resist…
Outcomes of single versus double hormone receptor–positive breast cancer. A GEICAM/9906 sub-study
2018
Abstract Background Retrospective data suggest better outcomes for patients with double hormonal receptor (oestrogen [ER] and progesterone receptor [PgR])–positive (dHR+) early breast cancer, compared with single hormonal receptor–positive, sHR+, (ER+/PgR– or ER–/PgR+) disease. Here, we evaluate the classification according to intrinsic subtypes and clinical outcomes of sHR+ versus dHR+ in HER2-negative breast cancer patients enrolled in GEICAM/9906 study ( NCT00129922 ). Methods Archival tumours were retrieved retrospectively for the analysis of ER, PgR and HER2 status and classified into intrinsic subtypes using the PAM50 gene expression assay. Disease-free survival (DFS) and overall surv…
Triple negative breast cancer: shedding light onto the role of pi3k/akt/mtor pathway
2016
// Daniela Massihnia 1,* , Antonio Galvano 1,* , Daniele Fanale 1 , Alessandro Perez 1 , Marta Castiglia 1 , Lorena Incorvaia 1 , Angela Listi 1 , Sergio Rizzo 1 , Giuseppe Cicero 1 , Viviana Bazan 1 , Sergio Castorina 2,3,** and Antonio Russo 1,** 1 Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy 2 Fondazione Mediterranea “G.B. Morgagni”, Catania, Italy 3 Department of Biomedical and Biotechnological Sciences, University of Catania, Catania, Italy * These authors have contributed equally to this work ** Both the authors are last name Correspondence to: Antonio Russo, email: // Keywords : ER, HER2, PI3K/AKT/mTOR inhib…
Standardisation of diet and exercise in clinical trials of NAFLD-NASH: Recommendations from the Liver Forum
2019
Abstract: Lifestyle modification is the foundation of treatment recommendations for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). The design of clinical trials in NASH may be impeded by the lack of a systematic approach to identify and evaluate how lifestyle changes and/or modifications influence clinical trial outcomes and associated endpoints. Furthermore, there are additional uncertainties regarding the methods that can be utilised to better characterise and quantify lifestyle variables - which can influence disease activity and alter trial endpoints - to allow for comparisons of trial outcomes across different phases of research and/or within drug-c…
[Herpes Zoster and its prevention in Italy. Scientific consensus statement].
2014
In this paper, an Italian group of experts presents a revision of the available data about epidemiology and prevention of Herpes Zoster (HZ). HZ is an acute viral diseases caused by the reactivation of Varicella Zoster Virus (VZV). HZ is characterized by neurological and dermatological symptoms with a dermatomeric localization. The reactivation of the virus from the latent status in the sensitive ganglia increases with age and failing cell mediated immunity. In Europe, more than 95% of adults presents antibodies against VZV. Incidence of HZ is similar all over the world, related to the age of the population: from 2-3/1000 persons/year in the age group 20 to 50 years to 5/1000 in the 60 year…