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.
This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.
Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications. CPSS is venous anomaly in which blood coming from the intestines only partially passes through the liver. This leads to the accumulation of potentially toxic factors that cause systemic effects. Complications vary among the individuals, and currently, it is challenging to predict which individuals will develop severe complications. The IRCPSS registry is established with the aim of centralizing detailed clinical follow-up and biological information from participants around the world who suffer from Congenital Portosystemic Shunt (CPSS). A multidisciplinary consortium of experts is collaborating to enhance our understanding of the prevalence, natural history, individual risks, and physiopathology of the disease through the IRCPSS registry.
In our previous study (title: Expression of Major Histocompatibility Complex Molecules class II- HLA-DR in Squamous Cell Carcinoma of the Head and Neck. ID 2222)the Authors verified that the epithelial cells of squamous cell carcinoma of the head and neck acquire the ability to express HLA-DR. Although the role of the expression of these molecules on neoplastic cells still remains controversial, a positive association between HLA-DR expression and clinical outcome was observed by us in analogy to what was reported by several studies on various types of tumors : in squamous cell carcinoma of the larynx, colorectal cancer , stomach cancer and others. In these tumors the expression of HLA-DR correlates with the presence of immune cells such as CD16+/CD11c macrophage myeloid cells, associated with a good prognosis and T cells which, recalled in the damaged tissue, they determine the formation of an immunogenic microenvironment that could support an anti-tumor immune response. Oncology studies are in fact focusing on the role of the tumor microenvironment which is characterized by different cell populations, among which the most abundant population is represented by tumor-associated fibroblasts (CAF). CAFs are fibroblasts which, in a tumor context, assume a phenotype similar to that of myo-fibroblasts and are distinguishable from normal fibroblasts by a greater expression of α-sma, FAP and FSP-1, which represent their specific markers, as well as a greater expression of vimentin, fibronectin, and type XI collagen. Numerous evidences in different types of tumors have reported both the immunosuppressive role, as these cells are capable in vitro of inhibiting the proliferation of T lymphocytes, to favor their apoptosis or to induce the phenotype of regulatory T lymphocytes; and the pro-tumor role, as they are capable of promoting tumor proliferation and invasion, angiogenesis and metastasis, thus contributing to the worsening of the prognosis. Many studies are directing their research on which factors secreted by CAFs are responsible for their function. In particular, among the many factors secreted by CAFs, there are the interleukins IL-17 and IL-33 which, as it has been demonstrated, can induce the activation of HLA-DR molecules on bone marrow-derived mesenchymal cells . It therefore seems interesting to investigate the role of HLA-DR in relation to the presence of the tumor microenvironment represented by CAFs.
RENOIR Study: This study will evaluate the safety, tolerability, and efficacy of Rosnilimab in subjects with moderate to severe Rheumatoid Arthritis (RA)
The MAST-GR study is a randomized controlled interventional trial with parallel treatment arms and 1:1 allocation The primary objective of the study is to compare the safety and efficacy of a single intra-articular infiltration of Bone marrow aspirate concentrate (BMAC) with one of minimally manipulated adipose tissue (MM-AT) so as to determine the most effective cellular product in treating patients with knee osteoarthritis (OA). The secondary objective is to demonstrate whether intra-articular infiltration of BMAC or MM-AT can induce disease-modifying effects in knee OA by imaging and biological assessments on peripheral blood. The tertiary objective of the study is to identify factors that influence the clinical response to treatment (baseline characteristics of patients, biological characteristics of the treated knee, characteristics of cellular products, BMAC and MM-AT).
The goal of this observational study is to assess the efficacy and safety of the probiotic Escherichia coli Nissle 1917 (EcN®, Ca.Di.Group S.p.A) in the treatment of symptomatic patients after an episode of both complicated and uncomplicated acute colonic diverticulitis. The main question it aims to answer are: - Is the studied probiotic able to significantly reduce symptoms, assessed by means of a validated and dedicated score? - Is there any difference in microbiota among the study group at baseline and a selected cohort of patients subdivided in subjects with diverticulosis and asymptomatic subjects after an episode of acute uncomplicated diverticulitis or an episode of complicated diverticulitis submitted to surgery with colonic resection without stoma? - Is there any difference in microbiota in the study group at baseline and after 3 and 6 months of treatment with the probiotic? - Is there any correlation between microbiota modification and symptoms during follow-up? - Is there any impact on fecal calprotectin values before and during probiotic therapy? - Is there any modification of evacuation before and during follow-up? - Is probiotic able to prevent recurrent episodes of acute diverticulitis during follow-up? - The safety of the probiotic will be assessed during the follow-up. The study group will be assessed at baseline and during follow-up with a dedicated clinical score and Bristol stool scale. Microbiota and fecal calprotectin values will be also assessed at baseline and during follow-up. Microbiota at baseline will be also evaluated for comparison in the three selected groups with diverticulosis and both asymptomatic and symptomatic after an episode of acute diverticulitis.
The EPIC-PRP study is a double-blind randomized controlled clinical trial with 1:1:1 allocation.The objective of the study is to evaluate by means of a randomized controlled, double-blind clinical trial the clinical outcomes of echo-guided injection of PRP with or without leukocytes compared with echo-guided injection of saline for minimally invasive treatment of patients with epicondylitis resistant to conservative therapy. It will be the aim of the study to evaluate the efficacy and safety of the injection procedures by revealing the improvement and incidence of adverse events following treatment
The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.
The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.
The purpose of this study is to evaluate the safety and tolerability of INCB099280 in combination with adagrasib and to establish the MTD or identify RDE(s) for the combination of INCB099280 and adagrasib.