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.
Based on robust evidence from literature, the investigators hypothesize the presence of disease-specific neurobiological underpinnings for bipolar and unipolar disorder, which may serve as biomarkers for differential diagnosis. However, the group comparison approaches adopted in psychiatric research fail to translate the emerging knowledge to the diagnostic routine. How can physicians predict differential diagnosis and treatment response by using cutting-edge knowledge obtained in the last decade? How can such extensive knowledge be useful and applicable in clinical practice? With this project, the investigators propose a solution to these challenges by developing a software tool that integrates the available clinical, biological, genetic and imaging data to predict diagnosis and outcome of new individual patients. The decision support platform will employ artificial intelligence, specifically machine learning techniques, which will be "trained" through data in order to predict the category to which a new observation belongs to. By doing this, existing and newly acquired multimodal datasets of bipolar and unipolar patients will be translated into predictors for personalized patient diagnosis and prognosis. The project can have a great impact on psychiatric community and healthcare system. Identifying predictive biomarkers for UD and BD will provide an essential tool in the early stages of the disease, ensuring accurate diagnosis, enhancing prognosis and limiting health care costs. The investigators will recruit 80 bipolar patients, 80 unipolar patients and 80 healthy controls for the MRI study. Clinical, genetic and inflammation data will be acquired from all subjects. The following data will be obtained: age, gender, number of episodes, recurrence, age of illness onset, lifetime psychosis, BD or UD familiarity, tempted suicide, medication, scores at HDRS, Beck Depression Inventory and BACS battery. MRI will be performed on 3.0 Tesla scanners. MRI acquisitions will include SE EPI DTI, T1-weighted 3D MPRAGE and fMRI sequences during resting state and a face matching paradigm, which previously allowed defining the connectivity in mood disorder. Blood samples samples will be collected and plasma will be extracted and stored at -80. Pro- and anti-inflammatory cytokines will be measured using the Bioplex human cytokines 27-plex. Genetic variants associated considered for differential diagnosis will be evaluated using the Infinium PsychArray-24 BeadChip. This cost-effective, high-density microarray was developed in collaboration with the Psychiatric Genomics Consortium for large-scale genetic studies focused on psychiatric predisposition and risk. The relevance of the single clinical, genetic, molecular and image-based features as bipolar and unipolar disorder signatures will be evaluated by considered the cutting-edge literature and estimated on a independent already existing dataset (30 subjects per group). General Linear Model analyses followed by two sided t-tests will be used to identify whether each parameter significantly differs among groups, while removing the contribution of age, gender, length of illness and other confounding factors. A multiple kernel learning (MKL) algorithm will project the multisource features to a higher-dimensional space where the three subject groups will be maximally separated. The selected features will be used both separately and in combination. The nuisance effects of age, gender, length of illness and MRI system will be corrected during the training phase of the algorithm. The MKL classifier will be tested using a k-fold nested cross-validation strategy with hyperparameter tuning. The training dataset is already made available and includes about 550 subjects. The software architecture will be designed in Matlab environment by integrating quantitative imaging methods, machine learning algorithm and statistical analyses as separate modules in a user-friendly interface, which will facilitate the sharing of computational resources in the clinical community.
Balneotherapy (BT) is recommended as non-pharmacological treatment for Fibromyalgia Syndrome (FS). BT efficacy is based on beneficial properties of both mud bath and stay in a spa environment. The main aim of this multicentric prospective longitudinal cohort study is to evaluate BT effectiveness in patients withFS. All FS patients with a stable treatment in the past month and a Fibromyalgia Impact Questionnaire (FIQ) score ≥39 will be enrolled after providing written informed consent. Patients will be divided into two groups based on whether or not BT is added to usual therapy: BT Group and Control Group. Each patients will be assessed at baseline, after 15 and 45 days in BT Group and at baseline and after 15 days in Control group with an assessment of pain by Visual Analogue Scale, FIQ, Short-Form Health Survey, State-Trait Anxiety Inventory (STAI) and Center for Epidemiologic Studies Depression Scale (CES-D). Collected data will provide a new insight of BT role and the removal of daily stress in FS management
The purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. These data will be collected in repeated visits over a 36-months follow-up period. At each visit, the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA) perimeter will be used to assess retinal functionality; an Optical Coherence Tomography (OCT) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.
With the risen popularity of low-dose computed tomography (LDCT) for lung cancer screening, many patients present with peripheral pulmonary ground-glass nodules (GGNs) with a suspicious solid part. The appropriate diagnostic and management strategy for those lesions can be questionable. If malignancy is suspected, a surgical biopsy with the guidance of various localization methods available is recommended. Each localization method has its advantages and disadvantages. Therefore, it may not be possible to establish a gold standard for localizing indeterminate lung nodules since comparative clinical trials are lacking.
Clinical trial in patients with Anorexia Nervosa using body-swapping technique e Virtual Reality Body Size estimation tasks and Autobiographic Recall on sympton remission (EDI-3; EDE-Q), body satisfaction and perception
This observational, prospective study aims at evaluating how the occurrence of post-Endoscopic Retrograde CholangioPancreatography (ERCP) acute pancreatitis (PEP) could be influenced by difficult biliary cannulation that might be previously assessed by the morphological appearance of native major papilla in all the patients undergoing ERCP. The rate of successful biliary cannulation across papilla types could be used as intraprocedural quality and competence metrics during training. Moreover, recognizing difficult papillae could allow reserving those to experts to decrease the odds of failed cannulation.
AIMS To evaluate the accuracy of HVPG (direct method), ICG-R15 and LSM/SSM (non-invasive methods) in predicting the risk of PHLF and hepatic decompensation; to evaluate the correlation between hepatic functional reserve (ICG-R15) and degree of portal hypertension (HVPG) and LSM/SSM in Child Pugh 0, A and B cirrhotic patients; to evaluate the real weight of HVPG in a multivariate analysis. METHODS: Multicentric observational prospective study. INCLUSION CRITERIA: All patients with liver cirrhosis with indication for surgical resection for hepatocellular carcinoma are considered eligible. Patients will be selected for surgery based on standard criteria of participating centers and on Child-Pugh score 0, A or B. EXCLUSION CRITERIA: Patients undergoing emergency surgery; inability to understand informed consent. Primary endpoint: Comparison of the predictive accuracy (evaluated as Area Under The Curve of the ROC curve, see statistics) of HVPG, ICG and Liver and Spleen Stiffness of Post-operative Hepatic Failure (PHLF, according to ISGLS). Secondary endpoints: - Predictive accuracy of HVPG, ICG-R15, LSM and SSM on postoperative morbidity at 90 days according to the classification of Clavien-Dindo and to the Comprehensive Complication Index (CCI), and on cirrhosis decompensation at 3 months after surgery.
The Perceval sutureless aortic bioprosthesis is a bovine pericardium valve mounted in a nitinol stent that can be compressed and positioned in a valve delivery system. Similarly, to transcatheter aortic valve implantation (TAVI) devices, the anchoring and good sealing of the Perceval bioprosthesis relies on oversizing by design of the nitinol stent compared with the native aortic annulus. With the advent of TAVI, cardiac computed tomography (CT) has become the gold standard technique for measuring the aortic annulus in patients undergoing transcatheter procedures, and the CT-derived axial image of the aortic virtual basal ring (VBR) is considered as the reference for sizing by most of the manufacturers of transcatheter valves . Interestingly, the VBR lies exactly on the plane passing through the nadir of the 3 aortic cusps, that is where, according to the instructions for use, a correctly positioned Perceval valve should be deployed. VBR could then provide a good estimate of the annular dimension for the Perceval pre-operative sizing.
Prospective follow-up of children with SARS-CoV-2
This study will investigate the role of genetic modifiers in hemoglobinopathies through a large-scale, multi-ethnic genome-wide association study (GWAS).