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Mario Del Tacca,1,2 Giuseppe Pasqualetti,3 Giovanni Gori,1 Pasquale Pepe,1 Antonello Di Paolo,2 Marianna Lastella,2 Ferdinando De Negri,1 Corrado Blandizzi2 1Clinical Pharmacology Centre for Drug Experimentation, Pisa University Hospital, 2Department of Clinical and Experimental Medicine, 3Geriatrics Unit, University of Pisa, Pisa, Italy Purpose: The primary aim of the present study was to assess the pharmacokinetic bioequivalence between a generic formulation of meloxicam 15 mg tablets (Meloxicam Hexal) and its respective brand product (Mobic), in order to verify whether the generic product conforms to the regulatory standards of bioequivalence in the postmarketing setting. As a secondary exploratory aim, the pharmacodynamic effects of the two formulations were also evaluated by means of rating scales following hyperalgesia induced by cutaneous freeze injury. Subjects and methods: A single 15 mg dose of generic or branded meloxicam tablets was administered to 24 healthy male volunteers in a crossover fashion. Plasma samples, collected for 24 hours after dosing, were assayed for meloxicam concentration by a validated high-performance liquid chromatography method. Results: The analysis of pharmacokinetic parameters did not show any significant difference between the two meloxicam formulations: the 90% confidence intervals fell within the acceptance range of 80%–125% (0.84–1.16 for area under the curve [0–24], and 0.89–1.23 for peak concentration). No difference in the pharmacodynamic end point was observed between the two groups. Conclusion: The pharmacokinetic profiles of the two meloxicam formulations confirm the regulatory criteria for bioequivalence; pharmacodynamic data indicate a similar antihyperalgesic effect. The two formulations can be used interchangeably in the clinical setting. Keywords: meloxicam, pharmacokinetics, healthy volunteers, generic drug, bioequivalence, postmarketing

Football, or soccer, is a simple game. It requires very little in the way of practical resources. Markers for a goal, a ball-shaped object. This simplicity enables the sport to be undertaken almost anywhere. Yet the beach is one place the game requires a substantial rethink in approach and participation. The best players do not necessarily make the best beach soccer players. For many Australians, the coastal edge of their continent is more than a key location for leisure and pleasure. The beach is an integral part of their culture, a symbol of their egalitarian nature, with a history of iconic sporting competitions, including the Sydney 2000 Olympics beach volleyball. Where beach soccer draws on notions of literal and figurative level-playing fields, this paper examines histories, practices, and myths and offers the first academic insight and discussion of Australian beach soccer. [ABSTRACT FROM AUTHOR]

The aim of this study was to examine the effect of single bouts of moderate-intensity aerobic exercise and moderate-intensity resistance exercise performed in the evening on the sleep of healthy young males. The study employed a repeated-measures, counterbalanced, crossover design with three conditions (control, evening aerobic exercise, evening resistance exercise). Twelve male participants (mean ± SD; age: 21.9 ± 2.7 yr) attended the laboratory on three occasions separated by one day between each visit. Between 20:45 h and 21:30 h, participants completed either no exercise, 30 min of aerobic exercise at 75%HRmax, or 30 min of resistance exercise corresponding to 75% of 10-repetition maximum. A 9-h sleep opportunity was provided between 23:00 h and 08:00 h. Core body temperature was measured using ingestible temperature capsules and sleep was measured using polysomnography. Core body temperature was higher during the aerobic exercise and resistance exercise compared to control (p = 0.001). There was no difference in core body temperature at bedtime between the conditions. Sleep onset latency, total sleep time, slow-wave sleep duration, REM sleep duration, wake after sleep onset and sleep efficiency were similar in each condition (p > 0.05). Single bouts of moderate-intensity aerobic exercise or moderate-intensity resistance exercise performed in the evening did not impact subsequent night-time sleep. Core body temperature increased during both forms of exercise, but returned to pre-exercise levels in the 90 min prior to bedtime. Healthy young males can engage in a single bout of moderate-intensity aerobic exercise or moderate-intensity resistance exercise ceasing 90 min before bed without compromising their subsequent sleep. [ABSTRACT FROM AUTHOR]

Abstract Background It is unclear whether patients with renal cell carcinoma (RCC) are routinely assessed for recurrence risk post‐nephrectomy and whether patients at high recurrence risk are seen by providers who can evaluate candidacy for adjuvant systemic therapy (AST) and clinical trials. Materials and Methods We identified all patients with locoregional RCC who underwent nephrectomy via an institutional database within Duke University Health System between 1 April 2015 and 31 December 2019. Medical records were reviewed to identify patient characteristics, post‐nephrectomy referrals, treatment, and follow‐up. Patients with tumor stage ≥3 and grade ≥2, regional lymph node metastasis, or both, were classified as high recurrence risk. Results Of 618 patients with locoregional RCC who underwent nephrectomy, 136 (22%) had high recurrence risk. Of those, 25 patients with high‐risk disease (18%) were referred to medical oncology for discussion of AST; 23 (92%) of these referrals took place in 2018–2019. One patient received adjuvant sunitinib and two patients participated in adjuvant immunotherapy trials. The decision not to receive AST was primarily made by the oncologist in 10 (46%), the patient in 8 (36%), and unrecorded in 4 (18%) of 22 cases, for multiple reasons. Individual surgeons referred high‐risk patients for discussion of AST with varying frequency, ranging from 0% to 100% in 2019. Conclusions Despite increasing number of patients with locoregional RCC at high recurrence risk referred to medical oncologists after nephrectomy, few patients received AST, including participation in clinical trials. With increasing AST options and ongoing clinical trials in this space, these findings highlight the need for continued efforts at identifying effective AST and referring patients most likely to benefit to medical oncologists. ClinicalTrials.gov, NCT04309617.

A letter to the editor is presented regarding a case of serotonin syndrome induced by phenelzine.

Background: Advanced therapy medicinal products (ATMPs) are an innovative output of biomedical research, characterized by a high level of uncertainty on long-term efficacy and safety, elevated price tags and often complex administration. All these elements compounded make their European authorization, national price negotiation for reimbursement and subsequent dispensation and administration to the patient less straightforward and often less successful than for less innovative drugs. To assess if these hurdles have affected patient access and how are ATMPs used in Italy, we have analysed availability, access and expenditure of ATMPs in the period spanning from 2016 to 2023., Methods: We have analysed real world data on the duration of ATMP regulatory evaluations for authorisation and reimbursement, time to first patient access and expenditure for ATMPs through the Italian National Health System (INHS) expenditure data flow, as well as information on patient mobility and availability of health facilities specialized in administering ATMPs., Findings: Of the 18 ATMPs currently authorized in Europe, 9 are reimbursed by the INHS, but only 6 were actually used, generating a cumulative expenditure of roughly 300 Mln€ from 2016 to 2023, largely owing to CAR-T therapies. Time to patient access reaches an average of 340.6 days from the day publication in the official Gazette of the reimbursement decision to first patient treatment in one of the 107 health facilities authorized for ATMP administration, after an even longer evaluation time by regulatory agencies., Conclusion: Since the first reimbursement decision for an ATMP in Italy, back in 2016, these innovative drugs became progressively more and more available, both in terms of numbers and in terms of coverage across the country. Almost all Italian regions have at least one centre for ATMP administration and has performed a treatment in 2023. Notwithstanding their high per-treatment prices, ATMPs currently have a rather contained expenditure, however it is bound to keep growing in the next few years., (© 2024. The Author(s).)

Insufficient sleep is a growing global problem, with poor sleep associated with many negative health and performance outcomes. Previous reviews investigating the effect of diet on sleep have highlighted the amino acid tryptophan as a promising sleep-promoting nutrient, with the richest food source of tryptophan, ⍺-lactalbumin, requiring further investigation. Therefore, this systematic review aimed to review the existing evidence of association between ⍺-lactalbumin and sleep. Four electronic databases (CINAHL Complete, Embase, MEDLINE Complete, and SPORTDiscus with Full Text) were searched from database inception to March 2023, with primary research articles included if they contained α-lactalbumin as an independent variable, an outcome measure of sleep or sleepiness, and participants were ≥ 18 years old. Eight studies were reviewed, with four studies recruiting athletic populations (50%) and four recruiting healthy participants (50%). Sleep or sleepiness was measured objectively in six studies (75%), with two studies employing polysomnography and four utilizing actigraphy to assess sleep. Across the studies, 20-60 g of ⍺-lactalbumin was supplemented, with five studies (63%) observing a positive association between α-lactalbumin and sleep. Sleep-onset latency was the primary sleep metric improved following evening supplementation of α-lactalbumin (≤ 3.5 hr pre-sleep), with no studies observing any negative associations with sleep. Data from this review suggest that individuals that have difficulty initiating sleep may benefit most from pre-sleep α-lactalbumin supplementation. Further research is required to establish the effect that α-lactalbumin has on sleep architecture, through the use of more comprehensive sleep analysis tools such as portable electroencephalography or polysomnography, in combination with stringent dietary controls., (© 2024 The Authors. Journal of Sleep Research published by John Wiley & Sons Ltd on behalf of European Sleep Research Society.)

Background: The aim of this study was to examine the effect of pressure training on the performance of semi-professional female rugby league athletes., Methods: Using a within-subjects design, 16 female athletes (19.9 ± 3.4 years) performed a passing accuracy task under three conditions; (1) a control condition; (2) a physiological fatigue condition; and (3) a threat of consequence condition. Passing performance, perceived pressure, rate of perceived exertion (RPE), and self-confidence were assessed., Results: A significant main effect of conditions was found for rate of perceived exertion ( p < 0.001), self-confidence ( p < 0.028), and perceived pressure ( p = 0.011). There was no main effect of condition on passing performance. Post hoc comparisons revealed that RPE was significantly higher in the physiological fatigue condition when compared to the control ( p = 0.009) and threat of consequence conditions ( p < 0.001). Perceived pressure was significantly higher in the threat of consequence condition compared to the control condition ( p = 0.037)., Conclusions: The main findings of this study are that (1) passing performance was not impacted by pressure training conditions, and (2) threats of consequences are an effective manipulation to generate pressure in female semi-professional rugby league players. These results offer nuanced insights into the impact of pressure generation in training environments for female semi-professional rugby league athletes.

Introduction: Recent sleep guidelines regarding evening exercise have shifted from a conservative (i.e., do not exercise in the evening) to a more nuanced approach (i.e., exercise may not be detrimental to sleep in circumstances). With the increasing popularity of wearable technology, information regarding exercise and sleep are readily available to the general public. There is potential for these data to aid sleep recommendations within and across different population cohorts. Therefore, the aim of this study was to examine if sleep, exercise, and individual characteristics can be used to predict whether evening exercise will compromise sleep. Methods: Data regarding evening exercise and the subsequent night's sleep were obtained from 5,250 participants (1,321F, 3,929M, aged 30.1 ± 5.2 yrs) using a wearable device (WHOOP 3.0). Data for females and males were analysed separately. The female and male datasets were both randomly split into subsets of training and testing data (training:testing = 75:25). Algorithms were trained to identify compromised sleep (i.e., sleep efficiency <90%) for females and males based on factors including the intensity, duration and timing of evening exercise. Results: When subsequently evaluated using the independent testing datasets, the algorithms had sensitivity for compromised sleep of 87% for females and 90% for males, specificity of 29% for females and 20% for males, positive predictive value of 32% for females and 36% for males, and negative predictive value of 85% for females and 79% for males. If these results generalise, applying the current algorithms would allow females to exercise on ~ 25% of evenings with ~ 15% of those sleeps being compromised and allow males to exercise on ~ 17% of evenings with ~ 21% of those sleeps being compromised. Discussion: The main finding of this study was that the models were able to predict a high percentage of nights with compromised sleep based on individual characteristics, exercise characteristics and habitual sleep characteristics. If the benefits of exercising in the evening outweigh the costs of compromising sleep on some of the nights when exercise is undertaken, then the application of the current algorithms could be considered a viable alternative to generalised sleep hygiene guidelines., Competing Interests: EC is a stakeholder and employee of WHOOP Inc. DM, GR, and CS are part of a research group in which WHOOP Inc. provides research funding. The remaining author declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Miller, Roach, Lastella, Capodilupo and Sargent.)

Objectives: Pregnant women frequently report experiencing poor sleep. Poor sleep during pregnancy is associated with negative health outcomes for both mother and baby. Physical activity (PA), including exercise may be an effective non-pharmacological strategy for improving sleep during pregnancy. The aim of this systematic review was to synthesize the current literature on the association between physical activity (including exercise) and sleep during pregnancy., Method: A systematic online search was undertaken between 15-16 February 2022 in PsycINFO, CINAHL, Embase and PubMed. To meet the inclusion criteria articles had to; [1] be published in a peer reviewed journal; [2] consist of pregnant participants; and [3] be published in English. Studies were excluded if they were not published in English and did not investigate the association between a type of physical activity (including exercise) and a sleep variable during a trimester of pregnancy., Results: Ten studies were included in this review. Five of the ten studies used observational data collection measures and the remaining five used intervention based methods. Eight of the ten included studies found PA (including exercise) was positively associated with sleep during pregnancy., Conclusion: In order to properly establish PA as a strategy to improve sleep during pregnancy, future research should aim to determine the PA characteristics most beneficial to sleep during pregnancy across each trimester.

As many as 80% of women report experiencing poor sleep throughout pregnancy. Exercise is associated with many health benefits during pregnancy and is established as a non-pharmacological method to improve sleep in both pregnant and non-pregnant populations. Given the importance of sleep and exercise during pregnancy, the aim of this cross-sectional study was to (1) examine pregnant women's attitudes and beliefs towards sleep and exercise during pregnancy, and (2) investigate the barriers women face to achieving good sleep and engaging in healthy levels of exercise. Participants were comprised of 258 pregnant Australian women (31.3 ± 5.1 years) who completed a 51-question online survey. Almost all (98%) participants believed exercise during pregnancy to be safe, whilst over half (67%) believed participating in more exercise will improve their sleep. Over 70% of participants reported experiencing barriers such as physical symptoms related to pregnancy that negatively impacted their ability to exercise. Almost all (95%) participants reported experiencing barriers to sleep in their current pregnancy. Present findings suggest that overcoming intrapersonal barriers should be a priority for any intervention aiming to improve sleep or increase exercise levels in pregnant populations. Findings from the present study highlight the need for a better understanding of women's sleep experiences during pregnancy, and demonstrate how exercise may improve sleep and health outcomes.

Context: Athletes' sleep is the most important recovery strategy and has received growing attention. However, athletes may experience sleep disruptions due to numerous factors, such as training and competition workloads, travel, changes in sleep-wake schedules, and sleeping environments. They often spend nights in unfamiliar hotels, and sharing a bed, room, or both with another person might affect sleep duration and quality., Objective: To analyze the effect of sleeping in shared (SRs) versus individual (IRs) rooms on objective and subjective sleep and on slow-wave-sleep-derived cardiac autonomic activity during an official training camp in elite youth soccer players. Training and match workloads were characterized., Design: Observational case study., Setting: Hotel accommodations., Patients or Other Participants: Thirteen elite male youth soccer players., Results: Players slept longer in IRs than in SRs (+1:28 [95% CI = 1:18, 1:42] hours:minutes; P < .001). Sleep efficiency was higher in IRs than in SRs (+12% [95% CI = 10%, 15%]; P < .001), whereas sleep latency was shorter in IRs than in SRs (-3 [95% CI = -15, -4] minutes; P < .001). Subjective sleep quality was lower in IRs than in SRs (-2 [-3 to -2] arbitrary units; P < .001). No differences were found for slow-wave-sleep-derived cardiac autonomic activity or for training or match workloads between training camps., Conclusions: During soccer training camps, sleep may be affected by whether the athlete is in an SR versus an IR., (© by the National Athletic Trainers' Association, Inc.)