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36 result(s) for "De Sanctis, Angela"
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On the Geodesic Distance in Shapes K-means Clustering
In this paper, the problem of clustering rotationally invariant shapes is studied and a solution using Information Geometry tools is provided. Landmarks of a complex shape are defined as probability densities in a statistical manifold. Then, in the setting of shapes clustering through a K-means algorithm, the discriminative power of two different shapes distances are evaluated. The first, derived from Fisher–Rao metric, is related with the minimization of information in the Fisher sense and the other is derived from the Wasserstein distance which measures the minimal transportation cost. A modification of the K-means algorithm is also proposed which allows the variances to vary not only among the landmarks but also among the clusters.
On a Geometric Representation of Probability Laws and of a Coherent Prevision-Function According to Subjectivistic Conception of Probability
We distinguish the two extreme aspects of the logic of certainty by identifying their corresponding structures into a linear space. We extend probability laws P formally admissible in terms of coherence to random quantities. We give a geometric representation of these laws P and of a coherent prevision function P which we previously defined in an original way. We are the first in the world to do this kind of work: it is the foundation of our next and extensive study concerning the formulation of a geometric, wellorganized and original theory of random quantities.
Improving Virological Monitoring of HDV Infection: A Proof-of-Concept Comparative Study of Bosphore and AltoStar® Assays in Patients Treated with Bulevirtide
Hepatitis delta virus (HDV) infection is associated with severe hepatic complications and rapid progression towards liver cirrhosis and hepatocellular carcinoma. Accurate measurement of HDV RNA is critical for monitoring therapeutic responses, especially during treatment with novel therapies such as bulevirtide (BLV). This study compared the analytical performance of two HDV RNA quantification assays, Bosphore (Anatolia) and AltoStar® (Altona), focusing on their sensitivity, specificity, and potential implications for clinical management. Sixty-one clinical samples from twenty-four patients, including fifteen HDV-infected patients receiving BLV treatment and nine controls, were tested using each assay. Of 30 samples identified as HDV-negative by the Bosphore assay, 17 (56.7%) were HDV-positive with AltoStar®, demonstrating the superior sensitivity (p < 0.0001) of the latter assay. Quantitative analyses revealed consistently higher viral load measurements with AltoStar® compared to Bosphore, with a difference of 1.23 Log IU/mL and a moderate correlation (r2 = 0.7385) between assays. Each assay demonstrated a high specificity, with no false positives detected among control samples. However, our findings suggest that differences in assay sensitivity could impact the evaluation of virological response, highlighting the risk of false-negative results in chronically HDV-infected patients with low-level viremia. This emphasizes the need for careful assay selection to accurately monitor treatment outcomes.
Lactobacillus brevis CD2 for Prevention of Oral Mucositis in Patients With Head and Neck Tumors: A Multicentric Randomized Study
Oropharyngeal mucositis occurs in virtually all patients with head and neck cancer receiving radiochemotherapy. The manipulation of the oral cavity microbiota represents an intriguing and challenging target. A total of 75 patients were enrolled to receive Lactobacillus brevis CD2 lozenges or oral care regimen with sodium bicarbonate mouthwashes. The primary endpoint was the incidence of grade 3 or 4 oropharyngeal mucositis during radiotherapy treatment. There was no statistical difference in the incidence of grade 3-4 oropharyngeal mucositis between the intervention and control groups (40.6% vs. 41.6% respectively, p=0.974). The incidence of pain, dysphagia, body weight loss and quality of life were not different between the experimental and standard arm. Our study was not able to demonstrate the efficacy of L. brevis CD2 lozenges in preventing radiation-induced mucositis in patients with head and neck cancer. Although modulating homeostasis of the salivary microbiota in the oral cavity seems attractive, it clearly needs further study.
Upper limb function in Duchenne muscular dystrophy: 24 month longitudinal data
The aim of the study was to establish 24 month changes in upper limb function using a revised version of the performance of upper limb test (PUL 2.0) in a large cohort of ambulant and non-ambulant boys with Duchenne muscular dystrophy and to identify possible trajectories of progression. Of the 187 patients studied, 87 were ambulant (age range: 7-15.8 years), and 90 non-ambulant (age range: 9.08-24.78). The total scores changed significantly over time (p<0.001). Non-ambulant patients had lower total scores at baseline (mean 19.7) when compared to the ambulant ones (mean 38.4). They also had also a bigger decrease in total scores over 24 months compared to the ambulant boys (4.36 vs 2.07 points). Multivariate model analysis showed that the Performance of Upper Limb changes reflected the entry level and ambulation status, that were independently associated to the slope of Performance of Upper Limb changes. This information will be of help both in clinical practice and at the time of designing clinical trials.
24 Month Longitudinal Data in Ambulant Boys with Duchenne Muscular Dystrophy
The aim of the study was i) to assess the spectrum of changes over 24 months in ambulant boys affected by Duchenne muscular dystrophy, ii) to establish the difference between the first and the second year results and iii) to identify possible early markers of loss of ambulation. One hundred and thirteen patients (age range 4.1-17, mean 8.2) fulfilled the inclusion criteria, 67 of the 113 were on daily and 40 on intermittent steroids, while 6 were not on steroids. All were assessed using the 6 Minute Walk Test (6MWT), the North Star Ambulatory Assessment (NSAA) and timed test. On the 6MWT there was an average overall decline of -22.7 (SD 81.0) in the first year and of -64.7 (SD 123.1) in the second year. On the NSAA the average overall decline was of -1.86 (SD 4.21) in the first year and of -2.98 (SD 5.19) in the second year. Fourteen children lost ambulation, one in the first year and the other 13 in the second year of the study. A distance of at least 330 meters on the 6MWT, or a NSAA score of 18 at baseline reduced significantly the risk of losing ambulation within 2 years. These results can be of help at the time of using inclusion criteria for a study in ambulant patients in order to minimize the risk of patients who may lose ambulation within the time of the trial.
A Randomized, Double-Blind, Controlled Trial Protocol for Therapeutic Neuroscience Education in Chronic Migraine Patients: A Clinical–Neurophysiological Combined Study Design
Chronic migraine (CM) is a highly disabling condition, affecting about 2% of the global population. Non-pharmacological treatments can be optimal for their non-invasive nature. This prospective, randomized, double-blind, controlled trial aimed to test the efficacy of therapeutic neuroscience education (TNE) in CM. Early response biomarkers were also evaluated. A total of 80 CM patients were consecutively enrolled and randomly allocated to TNE or a general education program. Treatment effectiveness was evaluated at baseline (T1) and 2 months after the end of treatment (T4). We collected the responses to disability and comorbidity questionnaires at the start (T1) and end of treatment (T3, 10 weeks after start). Early response biomarkers were evaluated at screening (T0) and mid-way through the process (T2, 5 weeks after start). We expected that TNE would provide a greater benefit than the general education program, which served as the primary outcome of this study. We also expected that a change in clinical and neurophysiological measures could potentially occur, reflecting plasticity-induced reorganization and predicting clinical response. This is the first study selectively exploring the effect of TNE as a standalone treatment for CM. A new, effective treatment regime without interactions with other medication could be of great interest as an addition to migraine therapeutic strategies.
Long Term Natural History Data in Ambulant Boys with Duchenne Muscular Dystrophy: 36-Month Changes
The 6 minute walk test has been recently chosen as the primary outcome measure in international multicenter clinical trials in Duchenne muscular dystrophy ambulant patients. The aim of the study was to assess the spectrum of changes at 3 years in the individual measures, their correlation with steroid treatment, age and 6 minute walk test values at baseline. Ninety-six patients from 11 centers were assessed at baseline and 12, 24 and 36 months after baseline using the 6 minute walk test and the North Star Ambulatory Assessment. Three boys (3%) lost the ability to perform the 6 minute walk test within 12 months, another 13 between 12 and 24 months (14%) and 11 between 24 and 36 months (12%). The 6 minute walk test showed an average overall decline of -15.8 (SD 77.3) m at 12 months, of -58.9 (SD 125.7) m at 24 months and -104.22 (SD 146.2) m at 36 months. The changes were significantly different in the two baseline age groups and according to the baseline 6 minute walk test values (below and above 350 m) (p<0.001). The changes were also significantly different according to steroid treatment (p = 0.01). Similar findings were found for the North Star Ambulatory Assessment. These are the first 36 month longitudinal data using the 6 minute walk test and North Star Ambulatory Assessment in Duchenne muscular dystrophy. Our findings will help not only to have a better idea of the progression of the disorder but also provide reference data that can be used to compare with the results of the long term extension studies that are becoming available.
Exploring Predictive Factors for Bulevirtide Treatment Response in Hepatitis Delta-Positive Patients
Background: Hepatitis delta virus (HDV) infection represents the most severe form of viral hepatitis and is a significant global health challenge. Bulevirtide (BLV) is a novel therapeutic treatment that has resulted in variable response rates in HBV/HDV-coinfected patients. We evaluated clinical, virological, and polymorphic factors for the purpose of predicting BLV treatment success. Methods: Thirty HBV/HDV-coinfected patients received BLV monotherapy (2 mg/day) for 24 to 48 weeks. Baseline (BL) serum samples were collected to assess clinical parameters and virological markers (HDV RNA, HBV DNA, HBsAg, HBcrAg, anti-HBc IgG) at treatment weeks 24 (TW24) and 48 (TW48). Additionally, full-genome HDV sequencing and a phylogenetic analysis were performed. Finally, analyses of the HDAg protein sequence and HDV RNA secondary structure were conducted to evaluate potential associations with treatment response. Results: A significant reduction in HDV RNA levels was observed at TW48, with a virological response (HDV RNA undetectable or ≥2 Log decline from BL) achieved by 58% of patients. Median BL levels of anti-HBc IgG were significantly different between virological responders (39.3 COI; interquartile range [IQR] 31.6–47.1) and virological non-responders (244.7 COI; IQR 127.0–299.4) (p = 0.0001). HDV genotype 1e was predominant across the cohort, and no specific HDAg polymorphisms predicted the response. However, secondary structure analysis of HDV RNA revealed that a specific pattern of internal loops in the region 63–100 nucleotides downstream of the editing site may influence treatment response by impacting editing efficacy. Conclusions: This study revealed key factors influencing BLV efficacy in HBV/HDV coinfection. Lower baseline anti-HBc IgG levels strongly correlated with a positive virological response, suggesting that the liver’s inflammatory state affects treatment success. Additionally, the analysis of HDV RNA secondary structure in patients receiving BLV treatment revealed a higher editing efficiency in virological responders, highlighting areas for further research.