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.
Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . At the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not widely considered. Whereas, it is now well established that in patients with cardiac implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is associated with increased mortality and hospitalization for heart failure. The present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly caused by the lead. In 2009 approximately 720 000 CIEDs were implanted worldwide [7] and since then a continuous increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. However, limited data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs, particularly for the long-term results. With this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with CIEDs.
Patients with severe aortic regurgitation (AR) may be affected, in many cases, by a concomitant moderate or severe mitral regurgitation (MR). Tethering of the mitral valve leaflets and/or annular dilatation, both consequences of left ventricular dilatation, represent the most common mechanisms underlying the development of MR which can therefore be defined as "secondary" in this case. When both mitral and aortic regurgitation are severe, patients show a decreased survival due to the pathophysiological consequences of the combination of these pathological conditions. In this case, surgery on both diseased valves is required to interrupt the natural history of the disease and is widely supported by current guidelines. On the other hand, little is known about the fate and prognostic implications of moderate MR secondary to severe AR and whether or not it should be treated at the time of aortic valve surgery. For this condition, the current guidelines do not provide specific recommendations, referring generically to the decision of the Heart Team. To date, there are few data describing the evolution of moderate MR in patients undergoing surgery for severe AR and insufficient data to support recommendations regarding the treatment of moderate MR concurrently with treatment of AR, so that this decision is now entrusted to the evaluation of the Heart Team. It is therefore desirable to evaluate the outcomes of these patients. The aim of this study is to evaluate the short- and long-term fate of secondary moderate MR in patients undergoing aortic valve replacement for severe AR.
Multivalvular heart disease is a highly prevalent clinical condition that comprises 14.6% of the patients undergoing valvular surgery. Specifically, aortic valve regurgitation (AR) can be present in a considerable proportion of patients undergoing mitral valve (MV) surgery. In the Society of Thoracic Surgeons database, con- comitant aortic and mitral surgery accounted for 57.8% of the total multivalvular procedures with an unadjusted mortality rate of 10.7%. When both the aortic and MVs exhibit severe disease, con- comitant valve surgery is well-accepted by the surgical commu- nity and supported by current guidelines. On the other hand, when the aortic valve (AV) shows only moderate regurgita- tion, which would not be surgically treated if singly present, the appropriate management of the AV pathology at the time of MV surgery is still under debate. The American College of Cardiology guidelines state that aortic valve replacement (AVR) is reasonable (class IIa) in patients with moderate AR (stage B) while undergoing surgery on the ascend- ing aorta, a coronary artery bypass graft or MV surgery (level of evidence: C). Conversely, the latest European Society of Cardiology guidelines on valvular heart disease define as con- troversial the decision to treat the AV in patients with moderate AR who undergo MV surgery, considering the slow progression of this disease. In this group of patients, they advocate a heart team approach that will take into account the aetiology of AR, the life expectancy of the patient, the operative risk and other clinical factors. This disagreement may lead to uncertainty about how patients with less than severe AR should be managed during MV surgery, especially considering the burden of double-valve surgical procedures. The goal of this study is to evaluate the immediate and long- term outcomes, including the need for a new procedure on the AV, in patients with moderate AR at the time of MV surgery.
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.
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.
Health workers, especially those in patient-facing roles, had a significantly increased risk of COVID-19 infection, having serious outcomes, and risking spreading the virus to patients and staff. Vaccination campaign planning suggests allocating initial supplies of BNT162b2 vaccine to health workers given the importance of early protection to safeguard the continuity of care to patients. The aim of the study is to assess the effectiveness and safety of BNT162b2 vaccine among the health workers of Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG). The retrospective cohort study will be conducted among health staff working at the FPG. Vaccination data will collect from hospital records. The primary end points will be vaccine effectiveness and safety.
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
Dry eye disease (DED), also called keratoconjunctivitis sicca, is a multifactorial disease of the ocular surface characterized by loss of homeostasis of the tear film and accompanied by symptoms such as ocular discomfort and visual disturbance. The reported prevalence of DED estimates vary widely, from 5% to 33%, which may reflect both differing populations and inconsistent diagnostic criteria. Patients with moderate-to-severe DED may experience a reduced quality of life due to ocular pain, difficulty in performing daily activities, and depression. First-line therapy for treating dry eye consists of over the counter (OTC) artificial tear drops, gels, ointments, or lubricants. Sodium hyaluronate (commonly referred to as hyaluronic acid or HA) is a naturally occurring polymer and is ubiquitous throughout the interstitial cellular space in humans. It helps retain moisture in different types of tissue throughout the human body and aids lubrication between layers of tissue to eliminate friction - thus making it an ideal physiological tear film substitute. As a result of its coiled structure and large hydrophilic domains, HA attracts and retains a large amount of water, and therefore possesses the ability to retard water evaporation. Following instillation, HA-based solutions effectively moisturize the eye surface and prolong the beneficial wetting effect over time. Hyaluronic acid does not alter the normal surface of the eye like other types of tear substitutes. It closely mimics the properties of a normal, healthy tear film, with a longer retention time on the corneal surface than a cellulose-based tear substitute. HA gels have also been used successfully in ophthalmic surgery for many years. As a result of their unique physical and chemical properties, HA solutions are similar to natural tears. For that reason, they are widely used in ophthalmology as lubricant eye drops for the treatment of sensations of ocular dryness. For these reasons, an interventional, confirmative, post marketing clinical follow-up (PMCF) study was planned to evaluate the performance and safety of HA-based ophthalmic solutions (i.e. Irilens; Iridina; Afomill Lubricating Eye Drops) used to relieve dry eyes symptoms. 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) containing HA as key ingredient. The IPs are on the market with the following brand names: - Irilens; - Iridina; - Afomill Lubricating Eye Drops. Primary • To evaluate the performance of IPs used as intended to relieve dry eye symptoms. Secondary - To evaluate the efficacy of IPs used as intended to relieve symptoms of DED. - To evaluate the safety and tolerability of the IPs. - To evaluate the patient satisfaction of the IPs.
Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed. The study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.