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.
Prostate cancer is the second most common cancer in the male population. This pathology represents an oncological and public health problem especially in developed countries, due to a greater presence of elderly men in the population. Medical imaging plays a central role in the staging and restaging of prostate disease. Magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) are among the methods commonly used in normal clinical practice for the characterization of prostate cancer. To date, the study of these images is limited to a qualitative visual analysis, however there is increasing evidence relating to the usefulness of introducing a quantitative (or semi-quantitative) analysis of biomedical images. The current increase in available imaging data, and their quality, allows the application of artificial intelligence methods also in the medical field for the automation of tasks (e.g. automatic segmentation) and classification (e.g. tumor aggressiveness). The extraction of quantitative data, and more generally the study of tumor lesions, requires manual segmentation by one or more doctors. This process requires very long times as each image must be processed individually; furthermore, the result also depends on the level of experience of the doctor carrying out the segmentation and this could create a source of heterogeneity, affecting the reproducibility of the segmentation. AI-based automatic segmentation methods can be applied to medical images for the localization of tumor lesions, thus exceeding the limits of manual segmentation.
Ageing is characterized by a decline in neuromuscular control and a progressive loss of muscle mass, strength and power, leading to reduced mobility, loss of independence, higher hospitalizations rate, and increased all-cause mortality. Several studies suggest a non-linear decay of these age-related changes. Denervation-reinnervation processes, resulting in fewer but larger surviving motor units in advanced age, start as early as age 50-60yr and can be magnified in older adults (>75yr). Significant functional consequences in daily living activities are not usually observed until approximately 50yr. However, after 50yr, muscle strength/power reduction is accelerated and becomes faster than average muscle mass loss. Most observations come from cross- sectional studies and several confounding factors associated with secondary aging, such as physical activity levels, may contribute to (or compensate for) the observed age-related reductions in neuromuscular function. Compared to cross-sectional designs, prospective ones are advantageous in their ability to investigate fundamental mechanisms by excluding inter-subjects variability. In this project, the investigators will characterize longitudinal age-related changes in motor function, physical performance and muscle aerobic metabolism with an integrated approach. The investigators aim to combine classical methods of in-vivo and ex-vivo evaluation of neuromuscular function with innovative approaches for assessing changes and interactions between neural, structural and metabolic variables in two critical phases of ageing: 55-60yrs and 75-80yrs. Within each age-group, subjects will be classified based on their functional capabilities and divided in either active or sedentary. The investigators will describe the 2-yr time course of 1) mechanisms impairing neuromuscular function (denervation-reinnervation processes); 2) interactions between muscle structural changes and neural/metabolic impairments; 3) functional and metabolic changes occurring at whole muscle as well as single fibers level. The results will extend current understanding of physiological determinants of neuromuscular alterations in aging by identifying the course and rate of changes of specific factors that mediate functional loss and disability in older adults.
Among all the patients who underwent PET/CT with choline at our Institute between 2004 and 2007 to restage the prostatic disease following biochemical recovery of the disease, in this retrospective study the patients previously treated with radical prostatectomy, who present a progressive increase in the PSA value in the absence of hormone therapy and of which there is knowledge of the main clinical and follow-up data, with particular attention to survival data. The PET/CT study with Choline, being part of the normal standard diagnostic work-up of patients, was performed following the normal clinical protocol. With the retrospective analysis of the data, the time elapsed following the prostatectomy operation and the follow-up time after the Choline PET/CT study will be evaluated and patients who died due to prostate cancer will therefore be considered. Prostate cancer-specific survival, calculated as the interval between radical prostatectomy and death due to prostate cancer, will be used as the end point. The differences between prostate cancer-specific survival of patients with a positive choline PET/CT study and patients with a negative choline PET/CT study will be evaluated (log-rank test). Choline PET/CT will be considered positive if pathological findings with significant tracer uptake are identified. In the subpopulation of patients with a positive Choline PET/CT study, survival data will also be evaluated in relation to the site of positivity of the PET/CT study, in particular at the level of local recurrence, in the lymph node or skeletal site.
The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.
Glucocerebrosidase (GBA) mutations are the most common risk factor for Parkinson's Disease (PD). GBA-related PD(GBA-PD) exhibits a more malignant phenotype as compared to no-carriers. Still, the mechanisms behind the increased malignancy in GBA-PD are not well understood. The definition of biomarkers able to stratify PD clinical trajectories in PD is therefore crucial to identify effective treatments and support diagnosis.The investigators will examine the role of GBA-mutations in accelerating a-synuclein (a-syn) and synaptic pathologies in PD by combining neuroimaging (positron emission tomography-PET), biochemical and clinical features. This will illuminate the pathophysiology underlying GBA-mutations in PD and identify biomarkers for the malignant PD phenotype. Also, the investigators will combine longitudinal clinical and imaging/biochemical features to define a prognostic algorithm for predicting disease faster progression in GBA-PD and monitoring disease trajectories in unaffected GBA carriers.
The aim of this study is to identify biologically viable targets for the treatment of major depressive disorder (MDD) and anxiety disorder (AD) with the ultimate goal of guiding physicians' therapeutic strategies and identifying more effective and safer treatments for patients. Following the inclusion and exclusion criteria, the investigators will recruit 10 patients with a diagnosis of anxious-depressive disorder (MDD-AD) and 10 healthy controls (HC) subjects. Each participant will be evaluated by a team of expert psychologists and physicians, who will be conducting a structured interview and administering a set of psychopathological scales to assess the symptoms' severity. The participants will also undergo7T multimodal neuroimaging session (including T1-weighted, 1H-MRS and fMRI). In the second part of the study, murine models will be used to study the role of integrin β3 (Itgb3) and protocadherin 9 (Pcdh9) in glutamatergic transmission at a molecular level and to evaluate whether the electrophysiological and behavioral defects identified in Itgb3- and Pcdh9-knockout mice can be restored by CRISPR-mediated transcription activation (CRISPRa).
We will conduct an observational study involving a preliminary long-term follow-up designed to test how dysbindin-1 gene expression can modulate the efficacy of treatments with antipsychotics on clinical and neuropsychological outcomes. We will recruit 150 patients diagnosed with DB who required therapy with an atypical antipsychotic (aripiprazole or quetiapine or olanzapine) in combination with a medication mood stabilizer (lithium or other mood stabilizer), according to the standards of DB treatment. Treatment will be maintained stably for at least 6 months, unless the patient's clinical evolution makes a therapeutic switch inevitable. In light of the data in mice, we will correlate the clinical/neuropsychological response to antipsychotics with the presence of the functional DysBray haplotype of the DTNBP-1 gene, which has in the general population a relatively high prevalence (about 25 percent).
A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.
The clinical condition of severe cognitive-motor impairment of Disorders of Consciousness (DoC; e.g., Vegetative State - VS, and Minimal Consciousness State - MCS), is characterized by a high risk of developing clinical complications. In this study, the investigators propose a new Clinical Complications Scale (CCS) developed to assess the impact of clinical complications on the long-term evolution of a cohort of patients with DoC. This is a multi-site prospective observational study conducted in patients with Severe Acquired Brain Injury and DoC admitted to six centers of Fondazione Don Gnocchi (Italy), with clinical data collection not deviating from routine practice (except for CCS administration). The study is non-commercial and will have a maximum total duration of 24 months. It is planned to assess inter-rater agreement and concurrent validity with a similar instrument (CoCoS scale).
Postoperative pulmonary complications (PPCs) are common in children undergoing general anesthesia and are associated with prolonged stay in the hospital and high costs. Development of PPCs is associated with ventilator settings in adult patients undergoing general anesthesia. Data on perioperative ventilator settings in children are lacking, leaving the anaesthetist without guidance. Consequently, the current standard of care in perioperative mechanical ventilation in children is expected to be extremely heterogeneous, leading to ventilation with higher levels of energy than necessary. Therefore, it is highly necessary to evaluate the current practice in perioperative ventilation in children and to determine associations with PPCs.