There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Different classes of biological targeted therapies (b-DMARDs) are available for psoriatic arthritis (PsA) and seronegative rheumatoid arthritis (RA) (TNF inhibitors, anti-IL23, anti-IL17). A variable percentage of subjects, however, does not respond the first b-DMARD. Musculoskeletal ultrasound (US) and synovial tissue analysis could provide useful information on the top of clinical variables to predict response. The primary aim of this project is to create a global single-cell RNA sequencing atlas of PsA synovitis and to evaluate the predictive value of clinical, US and synovial variables (inflammatory cells and synovial tissue-single cell signature) on disease trajectory outcome and treatment response. Patients with PsA or seronegative RA at different disease stages will be enrolled. Clinical and US examination will be performed at baseline, 3, 6 and 12 months, while synovial biopsy at baseline and 6 months. The optimal combination of clinical, US and synovial variables to stratify treatment response will be developed. The sensitivity to change of US and synovial variables and their evaluation in patients achieving clinical remission will also be considered as secondary aims. The expected results will help the optimisation of treatment strategies in patients with PsA and seronegative RA.
Flares of immune-mediated inflammatory diseases, as Rheumatoid Arthritis (RA), are a major burden for patients in routine care. They occur unpredictably, adding to the physical and psychological burden of the condition. In this study we will deeply dissect the synovial tissue and peripheral blood signature of RA in sustained remission eligible to treatment discontinuation to better understand the individualized factors determining disease flare once biological treatment is discontinued. We expect that the combined study of synovial tissue, imaging and peripheral blood derived biomarkers, associated with disease flare after treatment discontinuation in RA in remission, will provide a tool for the routine assessment of RA eligible to treatment discontinuation reducing the relapse rate and increasing the optimization of the use of expensive pharmacological treatments only for patients still needing them.
Rheumatoid Arthritis (RA) is a chronic autoimmune disease that affects nearly 1% of the general population worldwide leading to joint inflammation, disability and increate mortality. Several factors are associated with disease activity and treatment outcomes. Among them, overweight/obesity status was demonstrated to be associated with higher risk of RA development and most importantly to different treatment response to biological DMARDs. Moreover, overweight/obese RA patients do show higher degree of synovial inflammation compared to lean RA patients. In this context, adipose tissue accumulation is associated with higher inflammatory burden through the secretion by activated mature adipocytes of adipokines with pro-inflammatory properties on innate and adaptive immune cells. Among them, Leptin is an important adipokine, released by mature adipocytes with multiple activating properties on immune cells as monocytes, macrophages, dendritic cells, T and B lymphocytes acting through the activation of its receptor LEPR via JAK/STAT pathway. In particular, leptin exerts its effects on macrophages populations through the promotion of M1 differentiation with pro-inflammatory phenotype. In our research hypothesis we expect that leptin levels does correlate with immunohistochemical scores of synovial inflammatory cells (CD68+, CD21+, CD20+ and CD3+) and CD31+ synovial vessels. Moreover, we expect that the inhibition of JAK/STAT signal using Tofacitinib may interfere with leptin activation action on resident synovial inflammatory cells expressing LEPR (as CD68+, CD20+ and CD3+) in particular restoring the M1/M2 phenotype ratio within resident macrophages populations. Finally, we expect that the inhibition of JAK/STAT signaling pathway by Tofacitinib will result in a significant reduction of synovitis degree in patients with higher leptin expression due to adipose tissue activation.
This is an observational study, conducted on subjects with neurological disorders primarily involving the frontal and parietal lobes of the brain. Throughout the indicated period, the study will aim to enroll 100 subjects divided into 30 units per year. Specifically, the study will be carried out on patients with fronto-parietal dysfunction for whom a prescribed a clinical investigation of electroencephalogram and MRI
The goal of this observational study is to identify early signs of poor neurodevelopmental outcome by performing specific neurological, neurophysiological and neuroimaging assessments in newborns with hypoxic-ischemic encephalopathy treated with therapeutic hypothermia. The main questions it aims to answer are: - Identify patients at risk of neuromotor, cognitive and epileptic sequelae - Plan early rehabilitation programs and future trials on early neuroprotection in infant at risk of neurodevelopmental disability Participants will be involved in serial assessment: - Before and after therapeutic hypothermia and before discharge: neurological assessment, according to the modified Sarna (t) score, Thompson's score and Hammersmith Neonatal Neurological Examination (HNNE); General Movement Assessment - Amplitude integrated electroencephalogram (aEEG) within 6 hours of life, for 6 hours. - Neonatal Cranial Ultrasonography within 6 hours of life, in the third and seventh day of life. - Brain magnetic resonance imaging between 7 and 14 days. - Electroencephalogram (EEG) within 7 days. After discharge study population will perform: - EEG between 3 and 6 months. - Neurological assessment using Hammersmith Infant Neurological Examination (HINE) at 3-6-9-12 months. - General Movement Assessment at 3 months. - Neurodevelopmental assessment using the Griffiths Mental Development Scales at 24 months. - Cognitive assessment using the Wechsler Preschool and Primary Scale of Intelligence between 36 and 41 months. - Motor performance assessment using Movement ABC between 42 and 48 months.
A pilot proof of concept clinical trial will be performed to demonstrate the restoration of gut barrier integrity by administration of beneficial anti-inflammatory gut microbial strains (Lactobacilli-enriched Vivomixx® probiotic) to new onset Type 1 Diabetes Children.
Breast microcalcifications are a common mammographic finding. Microcalcifications are considered suspicious signs of breast cancer and a breast biopsy is required, however, cancer is diagnosed in only a few patients. Reducing unnecessary biopsies and rapid characterization of breast microcalcifications are unmet clinical needs. This study intends to implement a classification method for breast microcalcifications (as begnin or malign) with Artificial Intelligence techniques on mammographic images, evaluating the diagnostic performance (accuracy) of this approach. Another aim is the development of a diagnostic tool able to determining in-situ the biomolecular characteristics of microcalcifications. Raman spectroscopy (RS) is a highly specific method from the biomolecular point of view and it is able to explore molecular composition of a given sample through its direct irradiation (through laser light) and the simultaneous acquisition of emission signals. RS information could be combined togheter with imaging features to implement an AI model for the combined classification of breast microcalcifications
The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
The use of robotic technologies in rehabilitation is an increasingly widespread practice in the health sector: the Lokomat is a medical device intended for walking rehabilitation, consisting of an exoskeleton, a treadmill and a harness that supports the body weight and acts as a safety tool This technology is useful in the rehabilitation of pathologies such as prenatal stroke, brain injury, paraplegia, multiple sclerosis and other motor, orthopedic and neurological problems. During these treatments, the psychological / emotional component of the patient is not properly considered and the success of the treatment remains focused on the motor-rehabilitation level. The management of subjective-experiential aspects remains in the hand of clinical figures (primarily physiotherapists) who have no tools for objective assessment other than their sensitivity. However, considering the experience is fundamental for the success of the therapy: this happens especially in the pediatric field, where clinical results improve significantly when children start therapy with a relaxed and positive mental state. The aim of this project is to investigate the rehabilitation experience of patients who perform gait rehabilitation by menas of the Lokomat system, considering the relationship between physiological parameters and moods. Therefore, the main goal is to monitor the patient's psychophysical condition before, during and after the rehabilitation activity, during the different sessions. This will allow describing, with qualitative and quantitative data, the user experience of the patient who undergoes a therapeutic treatment with the Lokomat.
The present project aims at identifying very early electrophysiological risk markers for language impairments. The long-term goals of the study include the characterization of learning developmental trajectories in children at high risk for language impairments. In this project, all the infants of the Medea BabyLab cohort are followed-up until school age. Since these infants have complete information on early electrophysiological markers, the final goal of the project is the characterization of their learning developmental trajectories and the construction of a multi-factor prognostic model that includes the neurophysiological processes underlying basic-level skills as potential biomarkers for predicting later reading and spelling skills.