Paola Baiardi

Background: Ultrasound (US) imaging is widely used in Nephrology for the non-invasive assessment of renal morphology and perfusion. This study investigates correlations between sonographic parameters and renal function measured as estimated glomerular filtration rate (eGFR). Methods: This single-center prospective cross-sectional study enrolled 130 patients undergoing renal ultrasound. Parameters included renal length, parenchymal thickness, cortical–medullary differentiation, renal volume, and intrarenal resistive index (IR). eGFR was calculated using the CKD-EPI formula. Statistical analysis assessed correlations and developed a multivariable predictive model. Results: Renal length and parenchymal thickness correlated positively with eGFR (r = 0.381 and 0.364, p < 0.001), while IR correlated negatively (r = −0.549, p < 0.001). Multivariate regression identified sex, renal length, IR, cortical–medullary differentiation, and solitary/shrunken kidney as significant predictors of eGFR. The final model showed a predictive correlation coefficient of r = 0.6632. Specific ultrasound parameters, particularly renal length and IR, show significant correlation with eGFR. Conclusions: A predictive model incorporating these factors may assist in estimating renal function non-invasively.

Highly stressful situations, such as the current COVID-19 pandemic, induce constant changes in the mental state of people who experience them. In the present study, we analyzed the prevalence of some psychological symptoms and their determinants in four different categories of healthcare workers during the second year of the pandemic. A total of 265 physicians, 176 nurses, 184 other healthcare professionals, and 48 administrative employees, working in different Italian healthcare contexts, answered a questionnaire including variables about their mental status and experience with the pandemic. The mean scores for anxiety and depressive symptoms measured more than one year after the onset of the pandemic did not reach the pathological threshold. In contrast, post-traumatic and burnout symptoms tended toward the critical threshold, especially in physicians. The main determinant of psychological distress was perceived stress, followed by job satisfaction, the impact of COVID-19 on daily work, and a lack of recreational activities. These results increase the knowledge of which determinants of mental distress would be important to act on when particularly stressful conditions exist in the workplace that persist over time. If well-implemented, specific interventions focused on these determinants could lead to an improvement in employee well-being and in the quality of care provided.

This study assessed the short-term effects of conventional (i.e., human-composed) and algorithmic music on the relaxation level. It also investigated whether algorithmic compositions are perceived as music and are distinguishable from human-composed music. Three hundred twenty healthy volunteers were recruited and randomly allocated to two groups where they listened to either their preferred music or algorithmic music. Another 179 healthy subjects were allocated to four listening groups that respectively listened to: music composed and performed by a human, music composed by a human and performed by a machine; music composed by a machine and performed by a human, music composed and performed by a machine. In the first experiment, participants underwent one of the two music listening conditions—preferred or algorithmic music—in a comfortable state. In the second one, participants were asked to evaluate, through an online questionnaire, the musical excerpts they listened to. The Visual Analogue Scale was used to evaluate their relaxation levels before and after the music listening experience. Other outcomes were evaluated through the responses to the questionnaire. The relaxation level obtained with the music created by the algorithms is comparable to the one achieved with preferred music. Statistical analysis shows that the relaxation level is not affected by the composer, the performer, or the existence of musical training. On the other hand, the perceived effect is related to the performer. Finally, music composed by an algorithm and performed by a human is not distinguishable from that composed by a human.

Background: Early nutrition affects the risk of atopy and infections through modifications of intestinal microbiota. The Prebiotics in the Prevention of Atopy (PIPA) study was a 24-month randomised, double-blind, placebo-controlled trial. It aimed to evaluate the effects of a galacto-oligosaccharide/polydextrose (GOS/PDX)-formula (PF) on atopic dermatitis (AD) and common infections in infants who were born to atopic parents and to investigate the relationship among early nutrition, gut microbiota and clinical outcomes. Methods: A total of 201 and 199 infants were randomized to receive a PF and standard formula (SF), respectively; 140 infants remained on exclusive breastfeeding (BF). Results: The cumulative incidence of AD and its intensity and duration were not statistically different among the three groups. The number of infants with at least one episode of respiratory infection (RI) and the mean number of episodes until 48 weeks of age were significantly lower in the PF group than in the SF group. The number of patients with recurrent RIs and incidence of wheezing lower RIs until 96 weeks were lower in the PF group than the SF group, but similar to the BF group. Bifidobacteria and Clostridium cluster I colonization increased over time in the PF group but decreased in the SF and BF groups. Bifidobacteria had a protective role in RIs, whereas Clostridium cluster I was associated with atopy protection. Conclusion: The early administration of PF protects against RIs and mediates a species-specific modulation of the intestinal microbiota. Trial registration: clinicaltrial.gov Identifier: NCT02116452.

Recently there has been a progressive loss of specialty related skills for nephrologists. Among the skills we find the kidney biopsy that has a central role in diagnosis of renal parenchymal disease. One of the causes might be the belief that the kidney biopsy should be performed only in larger Centers which can rely on the presence of a renal pathologist and on nephrologists with a large experience. This trend may increase in the short term procedural safety but may limit the chance of in training nephrologists to become confident with the technique. We evaluated renal biopsies performed from May 2002 to October 2016 in our Hospital, a mid-sized facility to determine whether the occurrence of complications would be comparable to those reported in literature and whether the increase in the number of biopsy performing physicians including nephrology fellows which took place since January 2012, after our Nephrology Unit became academic, would be associated to an increase of complications or a reduction of diagnostic power of renal biopsies. Three hundred thirty seven biopsies were evaluated. Patients underwent ultrasound guided percutaneous renal biopsy using a 14 G core needle loaded on a biopsy gun. Observation lasted for 24 h, we evaluated hemoglobin levels 6 and 24 h and kidney ultrasound 24 h after the biopsy. Complications occurred in 18.7% of patients, of these only 1,2% were major complications. Complications were more common in female (28%) compared to male patients (14,8%) (p = 0.004). We found no correlation between diagnosis, kidney function and complication rates; hypertension was not associated to a higher risk in complications. The increase of biopsy performing personnel was not associated to an increase in complication rates (18,7% both pre and post 2012) or with an increase of major complications (1.2% vs 1,2%). Kidney biopsy can be safely performed in mid-sized hospitals. Safety and adequacy are guaranteed even if the procedure is performed by a larger number of less experienced nephrologists as long as under tutor supervision, thus kidney biopsy should become an integral part of a nephrology fellow training allowing more widespread diffusion of this technique.

In the European Union (EU) and United States (US), specific regulations have been released to provide incentives to develop and sell orphan medicinal products. We analysed the status of orphan drugs designated that not yet received a marketing authorisation or already marketed for patients affected by rare diseases in the EU and US up to December 2015. For each drug, the following data were extracted: designation date, active substance(s), orphan condition and indication, trade name, approved therapeutic indication, approved ages, genetic nature of disease and if affects children. In the EU, 1264 Orphan Drug Designations have been granted and 133 medicinal products were approved covering a total of 179 indications and 122 rare conditions. Among these, 79 were approved under Regulation (EC)141/2000 (65 still listed in the Orphan Medicinal Products Register and 14 lost the orphan designation but still authorised) and 23 were approved centrally by the European Agency before the Orphan Regulation entered into force. On the other hand, in the US 3082 designations and 415 orphan products, covering a total of 521 indications and 300 rare conditions, were granted. As a result, the mean of designations per year is 79 in the EU and 93.4 in the US, while the mean of approved indications per year is 8.5 in the EU and 15.8 in the US. No orphan product is marketed in the EU for bone and connective tissue, ophthalmic, poisoning/overdose, renal, urinary and reproductive rare diseases. Among the marketed medicinal products, only 46.6% in the EU and 35.2% in the US are approved for children. If all the existing market approvals were merged, 362 additional therapeutic indications in the EU and 72 in the US would be covered. Our data show that notwithstanding the incentives issued, the number of medicines for rare diseases is still limited, and this is more evident in certain therapeutic areas. However, by merging all the existing approvals, patients would benefit of substantial advantages in both geographic areas. Efforts and cooperation between EU and US seem the only way to speed up the development and marketing of drugs for rare diseases.

Changes in Research and Development of Medicinal Products since the Paediatric Regulation | InTechOpen, Published on: 2011-12-07. Authors: Adriana Ceci, Mariana Catapano, Cristina Manfredi, et