Montfort Sur Risle, France

How Complexity and Multiple Illnesses Affect Hospitalized Patients' Health: a Multicenter Study

Telehealth Intervention for Infants with Prodromes of ASD

Night-shift Work and Breast Cancer

Certain bodily functions, such as wakefulness and sleep, regulation of blood pressure and body temperature, the immune system, gene expression, and secretion of hormones--think of cortisol, for example--follow variations that are stably repeated every 24 to 25 hours. The biological clock that marks this cyclical rhythm is represented by neurons in the suprachiasmatic nucleus of the hypothalamus. Of the circadian system, three components should be considered: (a) the input pathways that transmit signals to synchronize the endogenous central clock with the external environment, (b) the central clock generates rhythms, and (c) the output pathways that transmit the signal from the central clock to other regulatory systems in the brain and body. The most powerful regulator of the input pathways is light, which-as is well known-is captured by the five retinal photoreceptors, including the intrinsically photosensitive retinal ganglion cells [ipRGCs], which, through the production of melanopsin, transmit the signal to the central circadian clock. Such physiological mechanisms, which have remained unperturbed for thousands of years, have been disrupted by the spread of artificial lighting, which, inevitably, alters the natural synchronization of the internal clock with sunlight. The effects that this misalignment produces are clearly visible in night workers who frequently have to expose themselves to light at "atypical" hours. In this sense, in fact, according to current legislation (see Art. 1, Legislative Decree No. 66 of April 8, 2003, implementing Directives 93/104/EC and 2000/34/EC, concerning certain aspects of the organization of working time), a night worker is defined as anyone who works for a period of at least seven consecutive hours including the interval between midnight and 5 a.m. It follows with palpable evidence that there is an increased risk that, under night work conditions, the alteration of the sleep-wake rhythm may take on a chronic character. In this regard, scientific evidence about the effects of night work on short-term health is well established: such as insomnia, excessive sleepiness, difficulty in concentration or lack of energy. While there is also scientific evidence that some repercussions may also occur in the long term. This is, in that case, the moderately high risk of developing cardiovascular disease, type 2 diabetes, depression, and, not least, cancer. Indeed, in 2007, in light of scientific evidence, the IARC (International Agency for Research on Cancer) listed night work as a probable human carcinogen (Group 2). Breast cancer generally represents the second most frequent neoplastic disease in women. The incidence of new cases worldwide in 2017 was estimated to be 1.9 million, higher in industrialized countries. From a pathogenetic point of view, the association between night shift work and breast cancer is highly plausible.

AI and VR Devices for Eating Behavior Rehabilitation

Effectiveness of TeleVR App in Cognitive Decline and MCI Patients

This clinical trial aims to assess the effectiveness of a telerehabilitation program combined with a virtual reality (VR) app in enhancing cognitive performance and social skills in individuals with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI). Study Rationale SCD and MCI are considered critical stages in identifying individuals at risk for dementia. Both conditions are associated with cognitive and social impairments, as well as neurophysiological changes observable through advanced neuroimaging and EEG markers. While traditional cognitive rehabilitation has shown benefits, emerging evidence suggests that telerehabilitation combined with VR may offer enhanced outcomes through its interactive, engaging, and scalable nature. Primary Objective Evaluate the potential efficacy of a telerehabilitation plus VR intervention in improving cognitive performance and social cognition skills in patients with SCD and MCI. Secondary Objectives Assess neurophysiological changes (EEG and MRI biomarkers) following the intervention. Evaluate gait patterns and eye movement parameters. Investigate the usability and patient compliance of the VR app-based intervention. Study Design Type: Randomized Clinical Trial (RCT) Duration: 6 weeks intervention, with follow-up assessments at baseline (T0), post-intervention (T1), and 3 months after intervention (T2). Population: Individuals aged 40-80 with SCD or MCI (AD and PD subtypes). Intervention Groups: Experimental Group (EG): Participants will use two non-immersive VR apps ("NeuroNation" and "The Sims Mobile") on smartphones/tablets for cognitive and socio-emotional skill training. Training will occur 3 times per week, 30 minutes per session, guided remotely by therapists. Active Control Group (aCG): Participants will follow a traditional cognitive rehabilitation program using paper-based exercises targeting cognitive domains. Assessment Tools: Neuropsychological Assessment: MMSE, MoCA, FAB, Stroop Test, RAVLT, Trail Making Test (TMT-A/B), and more. Neurophysiological Assessment: EEG and MRI scans for brain activity and structural analysis. Gait Analysis: Timed Up and Go (TUG) Test with BTS G-WALK®. Eye Movement Analysis: Using an eye-tracking system for fixation, saccades, antisaccades, and smooth pursuit eye movements. Usability Assessment: System Usability Scale (SUS). Expected Outcomes: Improved cognitive and social cognition performance in the experimental group compared to the control group. Observable changes in EEG and MRI biomarkers correlating with cognitive improvements. Enhanced usability and acceptance of VR-based telerehabilitation tools among participants. Significance of the Study: This trial seeks to bridge the gap between traditional cognitive rehabilitation and innovative, scalable, and cost-effective digital health interventions. Positive outcomes could establish telerehabilitation with VR as a standard intervention for cognitive and social rehabilitation in at-risk populations. The study adheres to ethical principles outlined in the Declaration of Helsinki, and informed consent will be obtained from all participants before enrollment

Exploring Virtual Reality As an Intervention for Food Selectivity: a Clinical Trial

Synchrony and Reciprocity of Body Movements and Prosody Between Psychotherapist and Patient

COntact RElationship in Neonatal Intensive Care Unit

Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Classical Philadelphia-negative myeloproliferative neoplasms (Ph-neg MPNs) including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF) are characterized by uncontrolled clonal proliferation of multipotent bone marrow progenitors, sustained by acquired mutations in JAK2, CALR and MPL genes. Natural history of PV is marked by life threatening outcomes such as thrombosis, bleeding and clonal evolution towards myelofibrosis and acute myeloid leukemia. Treatment-relevant risk stratification is designed to estimate the likelihood of thrombotic complications, which is estimated to occur before or after diagnosis in 20-30% of patients according disease and patient-related risk factors. The cornerstone of treatment in PV includes scheduled phlebotomy, with a hematocrit (Hct) target of <45% and low-dose aspirin in all patients, regardless of risk category. There is currently broad consensus regarding the need for cytoreductive drugs in high-risk patients with PV identified by age >60 years and prior history of thrombosis. The results of several andomized trials for the treatment of PV are now available, and, in addition to the standard drug hydroxyurea (HU), both a new ropegylated formulation of interferon alfa-2b3 and ruxolitinib4 are now available have been approved in Europe and US and European LeukemiaNet (ELN) investigators have recently provided recommendations for the use of these drugs in clinical practice in low-risk as well as high-risk patients. After approval by EMA (2019) and FDA (2021), the drug (ROPEGINTERFERON ALFA-2B) was very recently approved and reimbursed by AIFA (2022) in some subgroups of patients with PV. The use of this drug in clinical practice is an opportunity for a prospective observational study in a rare disease such as PV; the aim is to evaluate its impact in the practical management of these patients, according to Determinazione AIFA 20 marzo 2008 about observational clinical studies, and Decreto Ministeriale 17 dicembre 2004 on non-profit studies. It is not entirely known which is the percentage of patients who, after careful screening as required in good clinical practice, will fail the indications for concomitant clinical or laboratory abnormalities. Furthermore, the proportion of patients who discontinue the drug during follow-up for intolerance or other reasons is currently unknown and data on the benefit-risk ratio are limited. Moreover, it should be noted that the haematological and clinical responses obtained in clinical trials not always are replicated in the studies of the real-world clinical practice. In fact, daily management of PV patients does not require the same stringent enrollment and follow-up criteria as instead are necessary in clinical trials. Our proposal may also contribute to better implement the results following the recent guidelines, particularly in some subgroups of patients in which AIFA has established the use with reimbursement by Italian National Health System (NHS) (i.e., patients intolerant to HU, women of childbearing age who plan pregnancy and patients with history of skin cancer).

A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis

The drug being tested in this study is called vedolizumab. This study will look at the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of vedolizumab in pediatric participants with active chronic pouchitis. The study will enroll approximately 30 participants. All the participants will be enrolled in a single treatment group to receive treatment with vedolizumab based on participant's weight mentioned as follows: - Participants with body weight greater than or equal to (>=) 30 kilogram (kg) will receive vedolizumab, high dose - Participants with body weight greater than (>) 15 to less than (<) 30 kg will receive vedolizumab, medium dose - Participants with body weight 10 to 15 kg will receive vedolizumab, low dose All participants will receive vedolizumab intravenous infusion at Day 1, and at Weeks 2, 6, 14, 22, and 30. Participants will also receive concomitant antibiotic treatment (ciprofloxacin, metronidazole, or other antibiotics) from Day 1 through Week 2. Participants with clinical response at the end of Part 1 maintenance at Week 34 will continue to Part 2 of the study and will receive vedolizumab intravenous infusion every 8 weeks from Week 38 through Week 78. This multi-center trial will be conducted globally. The maximum overall duration of the study is up to approximately 2 years. Participants will be followed up for 18 weeks after the last dose of the study drug for safety.