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.
Recombinant factor VIII for the prevention of bleeding in patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis
The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening.
Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear. The goal of this observational study is to characterise the gut-microbiota composition associated with alterations in brain structure and function during the ageing process and across neurodegenerative disorders. This is based on recent studies showing that changes in the human brain and in the microbiota composition, can indicate very sensitively and in a predictive way pathological development and, consequently, be used as markers of neurodegenerative diseases. The main questions it aims to answer are: - How variation in the gut-microbiota composition correlates with the normal brain ageing trajectory? - How dysregulation in the gut-microbiota correlates with pathological changes in brain regions in specific neurodegenerative disorders? - Can the impact of the gut-microbiota on the brain be modulated by blood biomarkers? The investigators will recruit 40 young healthy participants, 40 old healthy participants, 40 participants with prodromal Alzheimer's Disease, 40 participants with Parkinson's Disease and 40 participants with Multiple Sclerosis. Participants will undergo the following examinations: - Magnetic Resonance Imaging - Analysis of a stool sample - Analysis of a blood sample - Neuropsychological assessment - Questionnaires on eating habits
The goal of this observational study is to investigate the effects of combination therapy with ARNI and inhibitors of SGLT2 in patients affected by HFrEF. The main questions it aims to answer are: - What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of ventricular remodeling studied by speckle tracking echocardiography (GLS%) and by variation of volumetric indices and contractile function (LVEDV, LVEDD, FE%)? - What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of variation of laboratory data indicative of heart failure (NT-pro-BNP)? - What is the medium-long term impact of the ARNI + glyphozine combination therapy in terms of major cardiovascular events (MACVE)? - What are the echocardiographic and laboratory parameters predictors of medium-long term major cardiovascular events (MACVE) and ventricular remodeling? Participants will undergo, at the time of enrollment and after approximately 3 and 12 months from the introduction of SGLT-2 inhibitor therapy, at clinical, echocardiographic and biohumoral investigations.
The purpose of this study is to learn if V940 which is an individualized neoantigen therapy (INT; formerly, called messenger ribonucleic acid [mRNA]-4157) with pembrolizumab (MK-3475) is safe and prevents cancer from returning in people with high-risk melanoma. Researchers want to know if V940 with pembrolizumab is better than receiving pembrolizumab alone at preventing the cancer from returning.
This is a randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy, safety, and tolerability of givinostat in non-ambulant male paediatric (aged 9 to <18 years) patients with DMD. 138 patients will be randomised 2:1 to givinostat or placebo and will be treated for 18 months. - Planned screening duration: approximately 4 weeks (±14 days) - Planned treatment duration: 18 months (approximately 72 weeks) - Planned follow-up duration: 4 weeks (±7 days) (for patients not participating in the long-term safety study) - Total duration of study participation: up to 83 weeks (ie, 20-21 months)
The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).
The aim of this study is to describe the development of the Work In Progress questionnaire, a tool designed to evaluate commitment in persons, and its psychometric validation process in the context of low back pain.
The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia. The main aims to answer are: - evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome. - evaluation of type and sequence of the therapies administered, the response rates, and the adverse events. - evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome. - evolution of autoimmune cytopenias into myelodysplastic syndromes. - a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism. Participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.
Autism spectrum disorder (ASD) is a common neurodevelopmental disorder characterized by language delay, impaired social interactions, and repetitive behaviors. Its manifestation varies among individuals due to genetic and environmental factors. Technology-based interventions, such as robots, serious games, virtual reality and immersive room, have shown better results in the cognitive-behavioral treatment of ASD. Visual attention, which is often deficient in individuals with ASD, is a focus in these interventions, as it can aid stimulus processing. Virtual reality offers a more ecological environment for such interventions. In this study, it has been demonstrated the effectiveness of virtual reality training by comparing the performance of an ASD group delivering treatment through the immersive room with a control group delivering traditional treatment. Fifteen children with ASD between the ages of 5 and 10 years, with IQs between 55 and 85 will be included in the trial and, following an assessment related to visual attention processes, will be randomly assigned to the control group and the experimental group. The trial participants will, first, undergo structured sessions to foster or increase the receptive area related to the stimuli to which they will be subjected during the training.