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.
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 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.
The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
The aim of the research is to evaluate the clinical outcome of short dental implants, characterized by a new macro-structural design and inserted in the upper or lower jaw in patients with reduced bone volume. The clinical outcomes will be compared for different surface treatments of implant neck and those of prosthetic components.
The overall objective of the study is to provide personalized nutritional advice based on the gut microbiota profile of children with type 1 diabetes (T1D) or obesity. Specifically, the primary objective of NUTRI-DIET is to validate a dietary model aimed at restoring bacterial species and/or anti-inflammatory metabolites in order to prevent extra-intestinal diseases characterized by dysbiosis, such as T1D and obesity. The primary endpoints of the study will be to monitor the glycemic control indices, i.e., blood glucose (mean of glycemic values, percentage of time-in-range value (TIR), which will be displayed by glycemic sensor) and glycated hemoglobin for diabetic children and Body mass index (BMI) z-score according to World Health Organization (WHO) recommendations (WHO BMI-for-age boys; WHO BMI-for-age girls) for obese children. The secondary objective of the study is to characterize the microbiota profile of the study patients and to test the algorithm under development built from the integration of diet and and gut microbiota composition data that were obtained during the previous observational study NUTRI-T1D.
Endovascular thermal ablation is currently considered as the best procedure for treating varicose veins thanks to its mini-invasiveness and the lowest rate of incidence of complications. At the end of the endovascular ablation procedure, the European Society of Vascular Surgery (ESVS) guidelines recommend the use of the compression stockings to reduce postoperative pain and the incidence of edema and thrombotic complications. Despite this, the duration, type and degree of compression to be used, particularly after radiofrequency ablation procedures, remain a matter of debate. Furthermore, although the benefits of postoperative elastic compression therapy are well known, there is various evidence demonstrating how patients often experience poor comfort in wearing stockings, especially those with a higher degree of compression, which causes poor compliance with therapy. In light of all this, each center recommends the use of elastic compression stockings in the postoperative period with a degree of compression that varies, however, according to internal protocols. There is currently no work in the literature that compares the advantages and disadvantages of using elastic compression stockings with a K2 versus K1 compression degree after radiofrequency ablative surgery.
The aim of the study is to verify the efficacy of microfragmented autologous adipose tissue with the Lipogems® system, in the treatment of perianal fistulas of m. Crohn's. The Lipogems® International, Milan, Italy, system is a sterile and disposable device that allows to harvest adipose tissue, process it and use it for intraoperative autologous transplantation of human adipose tissue mesenchymal cells that have a gene expression profile and phenotypic similar to that of adipose stem cells. The system consists of a container with metal beads capable of carrying out, by handling, a mechanical micro-fragmentation of the lipoaspirate and of a washing and filtering system which allows to progressively reduce the size of the adipose tissue clusters down to 0.2-0.8 mm and eliminate blood and oily residues. The processed Lipogems® is fluid and easily injectable and is rich in mesenchymal cells and pericytes. The processed Lipogems® will be injected around the fistulous tract and the tissue area closing the internal orifice to promote healing.
The object of this exploratory clinical trial is to evaluate post-operative complications in a population that underwent Robotic Assisted Radical Prostatectomy (RARP) made with multiple platforms: - DaVinci; - Hugo; - Versius. The questions it aims to answer are: - Does the estimation of the post-operative complications suggest something? - Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable? Participants will be invited to fill out questionnaires and join one of these three groups: 1. surgery with the daVinci platform; 2. surgery with the Hugo platform; 3. surgery with the Versius platform.