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Background Rimegepant, a novel oral calcitonin gene-related peptide receptor antagonist, has been recently approved for the acute migraine treatment. While its efficacy was confirmed in randomized clinical trials, no data is available regarding real-life effectiveness and tolerability. GAINER, a prospective, multicentric study, aimed to evaluate rimegepant effectiveness and tolerability in the real-world setting. Methods Our study involved 16 headache centers across Italy. The main outcomes were: i) 2 h pain freedom, and ii) occurrence of treatment-emergent adverse events after administration. Participants were instructed to treat one migraine attack with rimegepant 75 mg orally disintegrating tablet. Using an ad hoc diary, participants prospectively collected migraine attack features at baseline and every 30 min after rimegepant administration, up to 2 h post dose. A 24 h follow up was also collected. Results We enrolled 103 participants with migraine (74.8% female, mean age 44.4 [42.0 – 46.7] years, 24.3% with chronic migraine of whom 44.0% presented a concomitant diagnosis of medication overuse headache). The number of previously failed preventive classes was 2.7 [2.3 – 3.2]. Participants presented a mean of 9.6 [8.2 – 10.9] monthly migraine days at baseline. At rimegepant intake, 40.8% of patients rated migraine intensity as severe. Pain freedom 2 h post dose was reported in 44.7% (46/103) of individuals. Pain freedom 2 h post dose was not influenced by baseline pain severity ( p  = 0.316), but it was associated with timing of intake ( p  = 0.032) with a higher rate of 2 h pain freedom when rimegepant was taken within 1 h from pain onset. Mild adverse events were reported in 15.5% total attacks (16/103), predominantly fatigue ( n  = 6), gastrointestinal symptoms ( n  = 6), somnolence ( n  = 4), and transient cognitive difficulties ( n  = 3). Tolerability was rated as good-to-excellent in 85.4% cases (88/103). Conclusions Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants that includes subjects with episodic or chronic migraine, medication overuse and a high number of prior preventive treatment failures. Trial registration The study was preregistered on clinicaltrial.gov, NCT05903027.

Abstract Background There are major shortfalls in the identification and screening of at-risk migrant groups. This study aims to evaluate the effectiveness of a new digital tool (IS-MiHealth) integrated into the electronic patient record system of primary care centres in detecting prevalent migrant infections. IS-MiHealth provides targeted recommendations to health professionals for screening multiple infections, including human immunodeficiency virus (HIV), hepatitis B and C, active tuberculosis (TB), Chagas disease, strongyloidiasis and schistosomiasis, based on patient characteristics (including variables of country of origin, age and sex). Methods A pragmatic pilot cluster-randomized-controlled trial was deployed from March to December 2018. Eight primary care centres in Catalonia, Spain, were randomly allocated 1:1 to use of the digital tool for screening, or to routine care. The primary outcome was the monthly diagnostic yield of all aggregated infections. Intervention and control sites were compared before and after implementation with respect to their monthly diagnostic yield using regression models. This study is registered on international standard randomised controlled trial number (ISRCTN) (ISRCTN14795012). Results A total of 15 780 migrants registered across the eight centres had at least one visit during the intervention period (March–December 2018), of which 14 598 (92.51%) fulfilled the criteria to be screened for at least one infection. There were 210 (2.57%) individuals from the intervention group with new diagnoses compared with 113 (1.49%) from the control group [odds ratio: 2.08, 95% confidence interval (CI) 1.63–2.64, P < 0.001]. The intervention centres raised their overall monthly diagnosis rate to 5.80 (95% CI 1.23–10.38, P = 0.013) extra diagnoses compared with the control centres. This monthly increase in diagnosis in intervention centres was also observed if we consider all cases together of HIV, hepatitis B and C, and active TB cases [2.72 (95% CI 0.43–5.00); P = 0.02] and was observed as well for the parasitic infections’ group (Chagas disease, strongyloidiasis and schistosomiasis) 2.58 (95% CI 1.60–3.57; P < 0.001). Conclusions The IS-MiHealth increased screening rate and diagnostic yield for key infections in migrants in a population-based primary care setting. Further testing and development of this new tool is warranted in larger trials and in other countries.

Mediterranean Diet (Med Diet) is one of the healthiest dietary patterns. We aimed to verify the effects of weaning (i.e., the introduction of solid foods in infants previously fed only with milk) using adult foods typical of Med Diet on children eating habits, and on the microbiota composition. A randomized controlled clinical trial on 394 healthy infants randomized in a 1:1 ratio in a Med Diet group weaned with fresh; seasonal and tasty foods of Med Diet and control group predominantly weaned with industrial baby foods. The primary end point was the percentage of children showing a good adherence to Med Diet at 36 months. Secondary end points were mother’s changes in adherence to Med Diet and differences in children gut microbiota. At 36 months, children showing a good adherence to Med Diet were 59.3% in the Med Diet group and 34.3% in the control group (p < 0.001). An increase in adherence to the Med Diet was observed in the mothers of the Med Diet group children (p < 0.001). At 4 years of age children in the Med Diet group had a higher gut microbial diversity and a higher abundance of beneficial taxa. A Mediterranean weaning with adult food may become a strategy for early nutritional education, to develop a healthy microbiota, to prevent inflammatory chronic diseases and to ameliorate eating habits in children and their families.

We describe the behavior of a beam balance used for the measurement of small forces, in macroscopic samples, in tens of mHz frequency band. The balance, which works at room temperature, is the prototype of the cryogenic balance of the Archimedes experiment, aimed at measuring the interaction between electromagnetic vacuum fluctuations and the gravitational field. The balance described has a 50-cm aluminum arm and suspends an aluminum sample of 0.2 Kg and a lead counterweight. The read-out is interferometric, and the balance works in closed loop. It is installed in the low seismic noise laboratory of SAR-GRAV (Sardinia—Italy). Thanks to the low sensing and actuation noise and finally thanks to the low environmental noise, the sensitivity in torque τ n ~ is about τ n ~ ≈ 2 ∗ 10 - 12 Nm / Hz at 10 mHz and reaches a minimum of about τ n ~ ≈ 7 ∗ 10 - 13 Nm / Hz at tens of mHz, corresponding to the force sensitivity F n ~ of F n ~ ≈ 3 ∗ 10 - 12 N/ Hz . The achievement of this sensitivity, which turns out to be compatible with thermal noise estimation, on the one hand, demonstrates the correctness of the optical and mechanical design and on the other paves the way to the completion of the final balance. Furthermore, since the balance is equipped with weight and counterweight made of different materials, it is sensitive to the interaction with dark B-L photons. A first very short run made to evaluate constraints on B-L dark photon coupling shows encouraging results that will be discussed in view of next future scientific runs.

We report the tilt sensitivity reached by the ARCHIMEDES tiltmeter in the 2–20 Hz frequency region, where seismic noise is expected to give an important limitation to the sensitivity in the next future Gravitational Waves detection, particularly through Newtonian noise. The tilt noise level θ ~ ( f ) is about 10 - 12 rad / Hz in most of the band, reaching the minimum of θ ~ = 7 · 10 - 13 rad / Hz around 9 Hz. The tiltmeter is a beam balance with a 0.5 m suspended arm and interferometric optical readout, working in closed loop. The results have been obtained by a direct measurement of the ground tilt at the Sos Enattos site (Sardinia, Italy). This sensitivity is a requirement to use the tiltmeter as part of an effective Newtonian noise reduction system for present Gravitational Waves detectors, and also confirms that Sos Enattos is among the quietest sites in the world, suitable to host the third-generation Gravitational Waves detector Einstein Telescope.

IntroductionISMiHealth is a clinical decision support system, integrated as a software tool in the electronic health record system of primary care, that aims to improve the screening performance on infectious diseases and female genital mutilation (FGM) in migrants. The aim of this study is to assess the health impact of the tool and to perform a process evaluation of its feasibility and acceptability when implemented in primary care in Catalonia (Spain).Methods and analysisThis study is a cluster randomised control trial where 35 primary care centres in Catalonia, Spain will be allocated into one of the two groups: intervention and control. The health professionals in the intervention centres will receive prompts, through the ISMiHealth software, with screening recommendations for infectious diseases and FGM targeting the migrant population based on an individualised risk assessment. Health professionals of the control centres will follow the current routine practice.A difference in differences analysis of the diagnostic rates for all aggregated infections and each individual condition between the intervention and control centres will be performed. Mixed-effects logistic regression models will be carried out to identify associations between the screening coverage and predictor factors. In addition, a process evaluation will be carried out using mixed methodology.Ethics and disseminationThe study protocol has been approved by the institutional review boards at Hospital Clínic (16 June 2022, HCB/2022/0363), Clinical Research Ethics Committee of the Primary Care Research Institute IDIAPJGol (22 June 2022, 22/113-P) and the Almería Research Ethics Committee (27 July 2022, EMC/apg). The study will follow the tenets of the Declaration of Helsinki and Good Clinical Practice. All researchers and associates signed a collaboration agreement in which they undertake to abide by good clinical practice standards.Findings will be disseminated in peer-reviewed journals and communications to congresses.Trial registration number NCT05868005.