66 research outputs found

    Systematic versus on-demand early palliative care: results from a multicentre, randomised clinical trial

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    Background Early palliative care (EPC) in oncology has been shown to have a positive impact on clinical outcome, quality-of-care outcomes, and costs. However, the optimal way for activating EPC has yet to be defined. Methods This prospective, multicentre, randomised study was conducted on 207 outpatients with metastatic or locally advanced inoperable pancreatic cancer. Patients were randomised to receive ‘standard cancer care plus on-demand EPC’ (n = 100) or ‘standard cancer care plus systematic EPC’ (n = 107). Primary outcome was change in quality of life (QoL) evaluated through the Functional Assessment of Cancer Therapy – Hepatobiliary questionnaire between baseline (T0) and after 12 weeks (T1), in particular the integration of physical, functional, and Hepatic Cancer Subscale (HCS) combined in the Trial Outcome Index (TOI). Patient mood, survival, relatives' satisfaction with care, and indicators of aggressiveness of care were also evaluated. Findings The mean changes in TOI score and HCS score between T0 and T1 were −4.47 and −0.63, with a difference between groups of 3.83 (95% confidence interval [CI] 0.10–7.57) (p = 0.041), and −2.23 and 0.28 (difference between groups of 2.51, 95% CI 0.40–4.61, p = 0.013), in favour of interventional group. QoL scores at T1 of TOI scale and HCS were 84.4 versus 78.1 (p = 0.022) and 52.0 versus 48.2 (p = 0.008), respectively, for interventional and standard arm. Until February 2016, 143 (76.9%) of the 186 evaluable patients had died. There was no difference in overall survival between treatment arms. Interpretations Systematic EPC in advanced pancreatic cancer patients significantly improved QoL with respect to on-demand EPC

    Effect of RNS60 in amyotrophic lateral sclerosis: a phase II multicentre, randomized, double-blind, placebo-controlled trial

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    Background and purpose Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease with limited treatment options. RNS60 is an immunomodulatory and neuroprotective investigational product that has shown efficacy in animal models of ALS and other neurodegenerative diseases. Its administration has been safe and well tolerated in ALS subjects in previous early phase trials. Methods This was a phase II, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial. Participants diagnosed with definite, probable or probable laboratory-supported ALS were assigned to receive RNS60 or placebo administered for 24 weeks intravenously (375 ml) once a week and via nebulization (4 ml/day) on non-infusion days, followed by an additional 24 weeks off-treatment. The primary objective was to measure the effects of RNS60 treatment on selected biomarkers of inflammation and neurodegeneration in peripheral blood. Secondary objectives were to measure the effect of RNS60 on functional impairment (ALS Functional Rating Scale-Revised), a measure of self-sufficiency, respiratory function (forced vital capacity, FVC), quality of life (ALS Assessment Questionnaire-40, ALSAQ-40) and survival. Tolerability and safety were assessed. Results Seventy-four participants were assigned to RNS60 and 73 to placebo. Assessed biomarkers did not differ between arms. The mean rate of decline in FVC and the eating and drinking domain of ALSAQ-40 was slower in the RNS60 arm (FVC, difference 0.41 per week, standard error 0.16, p = 0.0101; ALSAQ-40, difference -0.19 per week, standard error 0.10, p = 0.0319). Adverse events were similar in the two arms. In a post hoc analysis, neurofilament light chain increased over time in bulbar onset placebo participants whilst remaining stable in those treated with RNS60. Conclusions The positive effects of RNS60 on selected measures of respiratory and bulbar function warrant further investigation

    Il colore della statualità. Leggi suntuarie, codici estetici e modelli culturali delle élites nella Napoli della prima Età moderna

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    Il percorso euristico che s’intende sviluppare ha un duplice obiettivo. Da un lato intende mettere in luce attraverso un’analisi giuridico e politico-istituzionale della legislazione suntuaria in che modo essa fosse funzionale agl’interessi della classe dirigente; dall’altro – passando dalla prospettiva teoretica all’analisi della pratique du systéme e delle mentalità sociali – il saggio intende ricostruire, servendosi degli inventari e delle cronache coeve, i modelli di consumo mettendoli in relazione con le gerarchie di valori delle élites della società napoletana della prima età moderna. Questa seconda parte del lavoro si giova non solo dell’analisi archivistica ma anche di quella iconografica. I ritratti, le sculture e alcuni rari, e per questo preziosissimi, materiali vestimentari del XVI secolo appartenenti al patrimonio artistico napoletano consentono di visualizzare con immediatezza quanto emerge dalla letteratura. Sul piano metodologico, si è ritenuto di affrontare questo tema in una prospettiva di comparazione con altre esterienze storiche europee. La scelta è dovuta a due specificità: la prima è relativa alla presenza del Regno di Napoli nel complesso sistema imperiale di Carlo V e al fondamentale ruolo geo-politico svolto dal Regno e dalle sue élites all’epoca delle guerre d’Italia; la seconda è invece legata all’evidenza che l’analisi della dinamica socio-istituzionale del Regno di Napoli può essere compresa appieno solo attraverso la comparazione con la Francia che, com’è noto, ha rappresentato il cuore propulsore del processo di civilizzazione socio-istituzionale
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