Efficacy of trans-nasal fiberendoscopic injection laryngoplasty with centrifuged autologous fat in the treatment of glottic insufficiency due to unilateral vocal fold paralysis.

SUMMARY: The objective of this work is to evaluate the safety, feasibility and efficacy of trans-nasal fiberendoscopic injection laryngoplasty (IL) with centrifuged autologous fat, performed under local anaesthesia, in the treatment of glottic insufficiency due to unilateral vocal fold paralysis (UVFP). It is a within-subject study with follow-up 1 week after phonosurgery and after 6 months. A total of 22 patients with chronic dysphonia caused by glottic insufficiency due to UVFP were enrolled. Each patient underwent trans-nasal IL with centrifuged autologous fat through flexible operative endoscope under local anaesthesia and was evaluated before and twice (1 week and 6 months) after phonosurgery, using a multidimensional set of investigations. The assessment protocol included videolaryngostroboscopy, perceptual evaluation of dysphonia, maximum phonation time and patient's self-assessment on voice-related quality of life (QOL) with the Voice Handicap Index-10 and the comparative self-assessment on vocal fatigue and voice quality pre-post treatment. Trans-nasal IL with centrifuged autologous fat was performed in all 22 patients and there were no complications in any case. Significant improvements in videolaryngostroboscopic findings, perceptual evaluation of dysphonia, maximum phonation time and QoL self-assessment were reported after 1 week and were maintained at 6 months. In one patient, the result after 6 months was not satisfactory and this patient then underwent a medialization laryngoplasty (thyroplasty type I) with satisfactory long-term results. In conclusion, trans-nasal fiberendoscopic IL with centrifuged autologous fat seems to be a safe, feasible and efficacious phonosurgical procedure for treatment of glottic insufficiency due to unilateral vocal fold paralysis.

CHARACTERIZATION OF 27 MEV PROTON BEAM GENERATED BY TOP-IMPLART LINEAR ACCELERATOR.

The first proton linear accelerator for tumor therapy based on an actively scanned beam up to the energy of 150 MeV, is under development and construction by ENEA-Frascati, ISS and IFO, under the Italian TOP-IMPLART project. Protons up to the energy of 7 MeV are generated by a customized commercial injector operating at 425 MHz; currently three accelerating modules allow proton delivery with energy up to 27 MeV. Beam homogeneity and reproducibility were studied using a 2D ionizing chamber, EBT3 films, a silicon diode, MOSFETs, LiF crystals and alanine dosimetry systems. Measurements were taken in air with the detectors at ~1 m from the beam line exit window. The maximum energy impinging on the detectors surface was 24.1 MeV, an energy suitable for radiobiological studies. Results showed beam reproducibility within 5% and homogeneity within 4%, on a circular surface of 16 mm in diameter.

Neonatal molding in deformational auricolar anomalies.

INTRODUCTION: Congenital auricular anomalies can be categorized either as malformational or deformational. The first are characterized by a partial absence of the skin or cartilage resulting in a constricted or underdeveloped pinna and require surgical correction. Deformations are characterized by a misshaped but fully developed pinna and are best treated by auricular molding. AIM: Authors want to present their case load in treatment of infants affected by deformational auricolar anomalies and describe their techniques using early splinting for congenital auricular deformities, like prominent ear, lop ear, constricted ear, Stahl's ear. PATIENTS AND METHODS: Between 2009 to 2011, in Maxillo and Oral Surgery Unit, a nonsurgical technique was used to treat 22 ears affected by deformational anomalies in 12 patients soon after birth. Four patients were female. This kind of nonsurgical correction of the deformed auricle was performed on lop ears (n=6), constricted ears (n=8), prominent ears (n= 4), Stahl's ear (n=4). Children more than two months old were also excluded. The mean of treatment time was 5.5 weeks. RESULTS: according to the Authors and the parents 100% of treated auricles improved. Improving at the end of the molding treatment was observed in 18% of the auricles, but recurrence to one year of stopping treatment. There were not complications caused by this procedure. CONCLUSIONS: The nonsurgical molding has the advantage to correct at a very early age a cosmetic abnormality, giving a natural and in the most of the time a satisfactory results, with a prevalence rate of complications of much less than surgical corrections.

Effects of pre-treatment with magnetic ion exchange resins on coagulation/flocculation process.

A new Magnetic Ion EXchange resin for DOC (Dissolved Organic Carbon) removal (MIEX DOC Resin) has been evaluated as water pre-treatment at the Drinking Water Treatment Plant (DWTP) of Florence in order to reduce the oxidant demand and disinfection by-products (DBPs) formation potential. This pre-treatment leads to several effects on downstream treatment processes. In this experimental study the effects of MIEX pre-treatment on clariflocculation process were evaluated with respect to coagulant demand reduction and characteristics of flocs formed. The analysis was conducted using traditional jar test procedures and a Photometric Dispersion Analyser (PDA2000) which provided continuous information about the aggregation state of particles during the jar tests. For a fixed turbidity goal in clarified water, ion exchange pre-treatment led to coagulant dosage reduction up to 60% and PDA results shown that flocs formed in pre-treated water were bigger and more resistant to shearing effects than those formed by conventional clariflocculation.

The behavioural phenotype of Cornelia de Lange Syndrome: a study of 56 individuals.

BACKGROUND: Few studies have investigated functional and behavioural variables of Cornelia de Lange Syndrome (CdLS) in a large sample of individuals. The aim of this study is to provide greater insight into the clinical, behavioural and cognitive characteristics that are associated with CdLS. METHODS: In total, 56 individuals with CdLS participated in the study. During hospitalization, their mothers received a number of questionnaires to complete. The behavioural phenotype was investigated using the following scales: Developmental Behaviour Scale Primary Carer Version; Autism Behaviour Checklist; Childhood Autism Rating Scale. RESULTS: Our participants demonstrated some behavioural characteristics that are frequently associated with CdLS (hyperactivity, attention disorder, anxiety, compulsive disorders, self-injurious behaviour and autistic-like features). Our findings demonstrate the variability of behavioural characteristics in CdLS in addition to highlighting the contribution of some variables to both the CdLS behavioural profile and the developmental trajectory of the behavioural pattern. CONCLUSIONS: The behavioural characteristics identified in our sample were correlated with some clinical and functional aspects (chronological age, cognitive level and clinical phenotype). The variability of the behavioural profile in CdLS reflected the wide variability in cognitive and adaptive functioning across individuals and led us to conclude that there may be multiple behavioural phenotypes associated with the syndrome. Further comparative studies between CdLS and individuals with intellectual disability or other genetic syndromes may help to provide further understanding of the behavioural phenotype of CdLS.

Evaluation of the nutritional status during stay in the subacute care nursing home.

Malnutrition represents an underestimated danger in the elderly population. It is found frequently and casually during admissions to our subacute care nursing homes (abbreviated from the Italian name: "Residenza Socio-Assistenziale" = RSA) when patients are treated for other types of disorders. During a period of 24 months, in our RSA, we found that 93% of patients were malnourished or at risk of malnourishment at admission. Specific interventions allowed us to substantially improve the nutritional status of these patients.

Medical device labeling and advertising: an overview.

The Food and Drug Administration (FDA) has the authority under the Federal Food, Drug, and Cosmetic Act (FDCA) to regulate the labeling of all medical devices. This statement, however, is not as simple as it appears. The regulation of medical device labels and labeling, closely linked to the advertisement of medical devices, is a dynamic area, and FDA is struggling to address the new issues that arise daily in this area. This article seeks to: 1) provide the background necessary to understand the current law and FDA's regulation of medical devices; 2) summarize the law and regulations governing medical devices; 3) define "intended use" and explain its importance; and 4) discuss several areas that are of particular interest to FDA, including promotion of uncleared or unapproved devices and uses, Internet promotion, press releases, and comparative claims.

FDA import alert: a potentially devastating enforcement tool.

The United States (US) operates strict measures to prevent foreign manufacturers from importing devices that it believes to be unsafe. The "Import Alert" issued by the Food and Drug Administration is a serious piece of legislation under which the device is detained and refused entry to the US until the manufacturer has taken corrective action. This article sets out situations in which an import alert would be issued, how manufacturers can avoid an import alert, and what to do if one is issued.

Anti-GM1 ganglioside IgM-antibodies present in human plasma: affinity and biological activity changes in a patient with neuropathy.

Low affinity anti-GM1 IgM-antibodies are part of the normal repertoire of human plasma antibodies (Mizutamari et al.: J Neuroimmunol 50:215-220, 1994), a fact that is against the pathological role proposed for them in autoimmune diseases. Here we present evidence that these low affinity IgM-antibodies are devoid of complement-mediated lytic activity to GM1-liposomes, suggesting that they should not be considered harmful. In contrast to the absence in normal individuals, in the plasma of a patient with sensory polyneuropathy we detected high affinity anti-GM1 IgM-antibodies. Concomitant with the presence of these high affinity anti-GM1 IgM-antibodies, the patient plasma is capable of producing complement-mediated lysis of GM1-liposomes. These results suggest that an increase in the affinity of the naturally existing anti-GM1 antibodies could be the trigger that switches them from non-harmful to pathological.