4 research outputs found

    Smoking-related cue reactivity in a virtual reality setting: association between craving and EEG measures

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    BACKGROUND: Cue-reactivity is the array of responses that smokers exhibit when exposed to conditioned and contextual stimuli previously associated to substance use. The difficulty to experimentally recreate the complexity of smokers' spatial experience and context requires more ecological models. Virtual reality (VR) creates a state of immersion close to reality allowing controlled assessments of behavioral responses. To date, no studies investigated brain activation associated to smoking cue-reactivity in VR using electroencephalography (EEG).AIMS: To investigate whether a VR cue-reactivity paradigm (a) may increase smoking craving, (b) is feasible with EEG recording, and (c) induces craving levels associated to EEG desynchronization.METHODS: Smokers (N=20) and non-smokers (N=20) were exposed to neutral and smoking-related VR scenarios, without and with smoking conditioned stimuli, respectively. EEG was recorded from occipital and parietal leads throughout the sessions to assess alpha band desynchronization. Smoking and food craving and presence visual analogue scales (VAS) were assessed during the session.RESULTS: To be smoker, but not non-smoker, significantly influenced smoking craving VAS induced by smoking cue VR but not by neutral VR. No significant food craving changes was observed during the VR sessions. The new finding was that EEG alpha band power in posterior leads was significantly increased by the smoking context scenario only in smokers, and that the degree of smoking (i.e., heavy vs. light) was significantly associated to this neurophysiological measure.CONCLUSIONS: This study demonstrated, for the first time, the feasibility of EEG recording in a VR setting, suggesting that EEG desynchronization may be a neurophysiological marker of smoking cue-reactivity

    A multicenter REtrospective observational study of first-line treatment with PERtuzumab, trastuzumab and taxanes for advanced HER2 positive breast cancer patients. RePer Study

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    We carried out a retrospective observational study of 264 HER2-positive advanced breast cancer (ABC) patients to explore the efficacy of first-line treatment with pertuzumab/trastuzumab/taxane in real-world setting. Survival data were analyzed by Kaplan Meier curves and log rank test. Median follow-up, length of pertuzumab/trastuzumab/taxane treatment and of pertuzumab, trastuzumab maintenance were 21, 4 and 15\ua0months, respectively. The response rate was 77.3%, and the clinical benefit rate 93.6%. Median progression-free survival (mPFS) was 21\ua0months, and median overall survival (mOS) was not reached. When comparing patients by trastuzumab-pretreatment, similar PFS were observed, although a longer OS was reached in trastuzumab-na\uefve patients (p\ua0=\ua00.02). Brain metastases at baseline and their development in course of therapy were associated with significantly shorter PFS (p\ua0=\ua00.0006) and shorter OS, although at a not fully statistically relevant extent (p\ua0=\ua00.06). The addition of maintenance endocrine therapy (ET) to pertuzumab/trastuzumab maintenance was associated with longer PFS (p\ua0=\ua00.0001), although no significant differences were detected in OS (p\ua0=\ua00.31). Results were confirmed by propensity score analysis (p\ua0=\ua00.003 and p\ua0=\ua00.46, respectively). In multivariate models, longer PFS was related to lower Performance Status (PS) (p\ua0=\ua00.07), metastatic stage at diagnosis (p\ua0=\ua00.006) and single metastatic site (p\ua0<\ua00.0001). An OS advantage was observed with lower PS (p\ua0<\ua00.0001), single metastatic site (p\ua0=\ua00.004), no prior exposure to trastuzumab (p\ua0=\ua00.004) and response to pertuzumab-based treatment (p\ua0=\ua00.003). Our results confirm that trastuzumab/pertuzumab/taxane is the standard of care as first-line treatment of patients with HER2-positive ABC even in the real-world setting. Moreover, the double-maintenance therapy (HER2 block and ET) is strongly recommended when feasible

    Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT) : a multicentre, randomised, placebo-controlled, phase 3 trial

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    Second asymptomatic carotid surgery trial (ACST-2) : a randomised comparison of carotid artery stenting versus carotid endarterectomy

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    Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86-1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91-1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable
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