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.
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of tobemstomig (RO7247669) in combination with platinum-based chemotherapy compared with pembrolizumab plus platinum-based chemotherapy in participants with previously untreated, locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small-cell lung cancer (NSCLC) who are not eligible to receive curative surgery and/or definitive chemoradiotherapy.
GEMINI-Hepatobiliary study will assess the efficacy, safety and tolerability of novel immunomodulators alone and in combination with other anticancer drugs in participants with specified advanced solid tumors.
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.
There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization. Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings. On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.
The goal of this single center non-interventional fMRI and EEG study is to assess the neural bases of social cognitive processing in healthy individuals, and whether/how their responsiveness is modulated by ageing. The main questions it aims to answer are: - are there specific brain regions where individual differences in social cognitive performance reflect well-established metrics of social cogntion such as empathy and mentalizing? - is there a relationship, at the behavioral and neural levels, between ageing-related changes in social cognitive performance and empathy/mentalizing? Healthy participants will be recruited for: - a behavioral assessment including multiple tests of social cognition focused on empathy and mentalizing; - for half participants: a fMRI session to collect data concerning a) brain activity associated with action observation and social cognitive processing, b) brain structural morphometriy (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging) - for half participants: a EEG session to collect data concerning brain responsiveness to social cognitive processing with higher temporal resolution than that afforded by fMRI. Results will provide an useful baseline for investigating alterations of social cognitive processing, and of their neural bases, in pathological conditions.
This behavioral study on healthy participants aims to provide a baseline reference for assessing alterations of decision-making performance in pathological conditions. To this purpose, this single center non-interventional behavioral study will assess the extent to which decision-making performance is affected by distinct experimental manipulations, as well as by ageing effects, in 200 healthy individuals. The main questions it aims to answer are: - to what extent is decision-making performance stable, within individuals, regardless of non-economic manipulations concerning stimuli perceptual features as well as type of processing and motor response required to participants? - are these manipulations additionally influenced by participants' age? Healthy participants will be recruited for distinct behavioral studies assessing the effects of the aforementioned manipulations of distinct metrics of decision-making performance, such as loss aversion, risk aversion, and delay discounting.
The goal of this single center non-interventional fMRI study is to assess the neural bases of decision-making and executive functioning in healthy individuals,and whether/how their responsiveness is modulated by ageing. The main questions it aims to answer are: 1. are there specific neural correlates for ageing effects on executive functioning (particularly inhibitory control) and decision-making? 2. Is there a relationship, at the behavioral and neural levels, between ageing-related changes in executive functioning and decision-making? Healthy participants will be recruited for 1. a behavioral assessment including multiple tests of decision-making and executive functioning/inhibitory control; 2. a fMRI session to collect data concerning a) brain activity associated with decision-making and executive functioning, b) brain structural morphometriy (grey-matter volume/density), and c) brain structural connectivity (diffusion weighted imaging). Results will provide an useful baseline for investigating alterations of decision-making and executive functioning, and of their neural bases, in pathological conditions.
The evaluation of carotid intima-media thickness (cIMT) has become a possible predictor of the future risk of cardiovascular diseases (CVD). Evidence to date shows that cIMT augmentation is correlated with the extent of atherosclerosis in the coronary arteries and with other risk factors for CVD. More recently, several studies have evaluated the association of cIMT with stroke, to determine whether this measure can also predict future cardiovascular events. Although the published evidence is scarce and fragmentary, the cIMT retains an increasingly interesting role as a marker of atherosclerotic pathology. The purpose of the study is to analyze cIMT in patients undergoing thyroidectomy to evaluate a possible correlation between the cIMT variation after the procedure and the cause of the thyroid disease, the levels of thyroid hormones, and the lipid or other markers of atherosclerosis levels. The primary endpoint will be the variation of the measure of the cIMT before and after surgery. Secondary endpoints will be: - major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the short-term period (≤30 days after the procedure); - major cardiovascular adverse events (death, major stroke, minor stroke, transient ischemic attack) in the long-term period (>30 days after the procedure); - the technical success of the procedure; - the rate of postoperative complications. To date, there are no data that differentiate patients based on the causes of thyroid disease. The results of the present study will allow for correlating the variation of the cIMT to the causes of thyroid disease, the levels of thyroid hormones, and the levels of lipid and other markers of atherosclerosis. Results from the present study may provide insights into possible areas of quality improvement. It may also influence the economic impact associated with carotid revascularization techniques, in terms of hospital charges and discharges to skilled nursing and rehabilitation facilities.
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients.
Study Rationale: The glaucomas are a group of optic neuropathies characterized by progressive degeneration of retinal ganglion cells. These are central nervous system neurons that have their cell bodies in the inner retina and axons in the optic nerve. Degeneration of these nerves results in cupping, a characteristic appearance of the optic disc and visual loss. The biological basis of glaucoma is poorly understood and the factors contributing to its progression have not been fully characterized. Glaucoma affects more than 70 million people worldwide with approximately 10% being bilaterally blind, making it the leading cause of irreversible blindness in the world. Glaucoma can remain asymptomatic until it is severe, resulting in a high likelihood that the number of affected individuals is much higher than the number known to have it. The tear film is fundamental in the maintenance of the ocular surface. Any condition that adversely affects the stability and function of the tear film such as dry eye symptom, blepharitis, and meibomian gland dysfunction, dysfunctional tear film syndrome, or toxicity of topical medications may result in onset of an ocular surface disease (OSD). The symptoms of OSD may include dryness, burning or stinging, itching, irritation, tearing, photophobia, foreign-body sensation, grittiness, redness, fatigue, fluctuating visual acuity, and blurred vision. OSD is a common comorbidity in glaucoma patients in part due to the fact thatits prevalence as in glaucoma increases with age. OSD is seen in approximately 15% of the general elderly population and is reported in 48% to 59% of patients with medically treated glaucoma. One in six patients with glaucoma has OSD symptoms severe enough that they need some form of treatment. Ophthalmic solutions with soothing and refreshing proprieties, as addon treatment to glaucoma therapy, could relieve the OSD symptomatology, dry eye like, in glaucoma patients, improving their quality of life. For these reasons, an interventional, confirmative, post marketing clinical followup (PMCF) study was planned to evaluate the performance and safety of ophthalmic solutions used to relieve dry eyes like symptoms in glaucoma patients. Study Objective: The objectives of this PMCF study are confirmation of the performance, collection of additional safety data regarding expected adverse events and detection of potential unexpected adverse events associated with use of three investigational products (IPs). The IPs are on the market with the following brand names: - Afomill Refreshing Soothing - Afomill Anti-redness Eye Drops - Iridil