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.
Anti tumor necrosis factor (TNF agents), particularly infliximab and adalimumab, changed the way chronic inflammatory bowel disease (IBD) refractory to conventional therapies is treated, including in pediatric patients. However, approximately 10-30% of patients do not respond to initial therapy and up to 50% lose response over time. Variability in response to therapy may be influenced by multiple interacting factors at different levels. Recent studies showed that measurement of serum infliximab concentrations during induction therapy predicts treatment effects at one year. Therefore, therapeutic monitoring of infliximab is proposed as a useful strategy to improve clinical outcomes and optimize healthcare resources. Most commercially available methods for infliximab quantification are based on the ELISA assay, which has an assay time of at least 8 hours. Recently, commercial point-of-care devices became available with assay times of less than one hour, enabling real-time therapeutic drug monitoring; however, validation of these devices in clinical settings and comparison with standard assays are still needed, particularly in pediatric patients. In addition, some studies suggest that loss of response in patients treated with anti-TNFs may be partly due to the emergence of specific anti-drug antibodies (AAFs). A limitation of the most widely used ELISA assays is the inability to quantify drug and AAF when they are simultaneously present. Recently, innovative ELISA assays have become available to overcome this problem. However, there is a lack of comparative studies between the classical and the specific method in terms of clinical response in pediatric patients. In patients who do not respond to infliximab, especially if they have high levels of AAF, guidelines call for the use of adalimumab. For this drug, the evidence in the literature regarding therapeutic monitoring of adalimumab concentrations and association with response in pediatric patients is still very preliminary. This study, carried out in in pediatric patients with IBD, aims to: 1. validate the "point of care" infliximab assay by comparing it with reference ELISA assays; 2. evaluate the correlation of infliximab and AAF levels, as measured by the innovative ELISA assays, with response to therapy, compared to traditional assays. 3. evaluate the association between adalimumab and AAF levels and response to therapy
In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care. This prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.
Non-profit, multicenter, prospective, observational study. This study aims to evaluate whether the articulated treatment algorithm that is now possible for OC patients does produce tangible changes of financial distress over the time and whether the determinants of financial distress change their relative weight over the time.
Human immuno-deficiency virus (HIV) is the virus that causes Acquired Immuno-Deficiency Syndrome (AIDS). HIV disease is considered to be a chronic disease requiring lifelong therapy. The purpose of this study is to assess change in disease activity, adverse events, tolerability, and how the drug moves through the body. Budigalimab and ABBV-382 are investigational drugs being developed for the treatment of HIV disease. Participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 7 chance that participants will be assigned to placebo (A placebo is not a drug and it is not expected to have any chemical effects on your body and it is not designed to treat any disease or illness). Approximately 140 adult participants living with HIV disease on stable antiretroviral therapy (ART) willing to undergo Analytical Treatment Interruption (ATI) will be enrolled at approximately 90 sites worldwide. Participants will receive 4 doses of IV budigalimab or placebo combined with 3 doses of IV ABBV-382 or placebo for an 8 week dosing period. Participants need to be stable on antiretroviral therapy to participate in the study. If participant qualifies to the study, on the day they receive the first injection, participants will be asked to stop antiretroviral medications (also referred to as analytical treatment interruption or ATI) for 52 weeks or until meeting specific criteria to restart antiretroviral medications. Participants will undergo a closely monitored ART interruption. Protocol-defined ART restart criteria includes participant's request. Participants will be followed for up to approximately 52 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. There will be an option for virtual or home health visits for some of the follow-up visits. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are: - evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life - describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.
The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.
CAD is a leading cause of mortality in Europe. cCTA is recommended to rule out obstructive CAD, but, in most patients, it shows non-obstructive CAD. The management of these patients is unclear due to lack of reproducible quantitative measurement, beyond stenosis severity, capable to assess the risk of disease progression towards developing MACEs. To improve identification and phenotypization of patients at high risk of disease progression, we propose the application of artificial intelligence algorithms to cCTA images to automatically extract periluminal radiomics features to characterize the atherosclerotic process. By leveraging machine-learning empowered radiomics we aim to improve patients' risk stratification in a robust, quantitative and reproducible fashion. By developing a novel quantitative AI based cCTA measure, we expect to provide a risk score capable to identify patients who can benefit of a more aggressive medical treatment and management, thus improving outcome
The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)
The identification of myocardial fibrosis in term of myocardial scar and extracellular matrix remodelling assessed respectively with the technique of Late Gadolinium Enhancement (LGE) and with the quantification of the Extracellular Volume Fraction (ECV) in Cardiac Magnetic Resonance has been demonstrated to be crucial in the diagnosis of different cardiomyopathy and to be prognosticators of major cardiovascular adverse events [1-14]. For these reason CMR represent the gold standard for the non-invasive characterization of myocardial tissue in the clinical practice. However, regardless of its indisputable clinical role, CMR has many limitations: 1) it does not allow to evaluate coronary arteries; 2) it is contraindicated in patients with cardiac devices, and in case of conditional device they may also significantly impair LGE assessability due to artefacts [19]); 2) has limited availability and it is time consuming, therefore it is difficult to perform in the acute setting also because of poor patient compliance; 3) it is not feasible in patients suffering from claustrophobia. Cardiac Computed Tomography (cCT) is the image of choice to non-invasively study coronary arteries, not assessable with CMR. Moreover the recent technological advancement has continuously increased the clinical indication to the evaluation of cardiac valve and fibrosis, with reduced acquisition time respect to CMR (few minutes vs 1 hour), radiation exposure and costs. cCT has emerging as a possible alternative to CMR in the characterization of myocardial scar and extracellular volume fraction, with the advantage of a single shot evaluation of coronary arteries and myocardial tissue remodelling (scar, diffuse fibrosis, contractility..).In particular, several studies including some from our group, have demonstrated the clinical utility of myocardial tissue characterization with cCT in different clinical settings, such as myocardial infarction [20, 21], myocarditis [22], hypertrophic cardiomyopathy (HCM) [23], heart failure [24], ventricular tachycardia [25], and sarcoidosis [26]. Despite the interesting results, all these previous studies are limited on highly selected and small sample size. Moreover, any large study with long term follow-up is available in the setting of tissue characterization (myocardial scar and ECV) in cCT also as well as combined with a multiparametric approach (cardiac chamber morphofuntionality,contractility-strain, valve calcification, geometry, coronary atherosclerosis, myocardial perfusion, myocardial strain and texture) and no data are available about its prognostic impact. Aim of the study is to evaluate the potential of cCT in tissue characterization (myocardial scar and ECV) alone and associate to other CT imaging biomarker on a large population of patient clinically candidate to cardiac CT.
Coronary artery disease (CAD) is a leading cause of mortality in western countries. Coronary computed tomography angiography (cCTA) is the first-line imaging test in patients with suspected obstructive CAD. However, in most patients, cCTA shows non-obstructive CAD. The management of patients with non-obstructive CAD is unclear. This is due to the lack of cCTA-based methods capable to assess the risk of disease progression towards developing major adverse cardiovascular events (MACEs) based on the atherosclerosis characteristics of each patient. A solution for prognostication in these patients is particularly appealing since it could allow to identify patients who can benefit of a more aggressive medical treatment and management, thus improving outcome. Proposed methods, which include qualitative evaluations such as the identification of adverse atherosclerotic plaque characteristics or quantitative evaluations such as the quantification of atherosclerotic plaque burden, may in some cases suffer of limited reproducibility between operators and software. Most importantly, each single biomarker is insufficient to accurately predict patient risk, hence potential synergic integration of cCTA and clinical biomarkers is the key to efficiently guide the personalization of patient's management. Furthermore, the few risk stratification methods that have been proposed are not designed to work on platforms capable of deploying the solution to other clinical settings, promoting prospective or external validation