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.
Tricuspid regurgitation (TR) was identified as an independent prognostic factor associated with excess mortality and morbidity, independent of left ventricular (LV) function and pulmonary hypertension. Isolated tricuspid surgery has been performed for a long time in a few selected cases, however in recent years several studies have underlined how the poor outcomes described for isolated tricuspid valve surgery seem to be related to the baseline characteristics of the patients and to late referral for surgical treatment rather than the intervention itself. To facilitate patient screening, a new clinical and functional TR staging system has recently been proposed. This classification, which evaluates the progression of morphological variations of the tricuspid valve and right ventricle (RV) in association with the onset of symptoms, identifies several parameters and factors that can be useful for a better stratification of surgical risk. Rather than simply assessing the degree of TR, this new staging mechanism also focuses on symptoms, RV remodeling and function, medical therapy, and right heart failure hospitalizations. Investigators previously focused on the short-term (mainly hospital) outcomes of patients undergoing isolated surgery for severe TR, who were classified at baseline according to this clinical and functional staging system. Results showed that a more comprehensive classification reflects the population and hospital outcomes of surgically treated patients with isolated TR. The purpose of this study is to ultimately evaluate long-term outcomes of this patients population and estimate the impact of baseline staging on long-term outcomes.
The present study aims at assessing long-term hemostatic profile of patients recovered from COVID-19 acute infection that remain asymptomatic (POST-COVID) versus patients with residual symptoms (LONG-COVID) through the employment of a commercially available new generation point-of-care viscoelastic device. The primary endpoint is based upon the hypothesis that patients with residual symptoms maintain an abnormal coagulation profile even after recovery from COVID-19.
Bloodstream infections due to Candida spp remain a serious medical challenge because of their high incidence and poor outcome. Diagnosis and monitoring of patients are still problematic, hindering efficient clinical management of the disease. The invastigators propose here to perform a retrospective study in a clinically well-characterized candidemic patient, with the goal of recognizing host immunological factors and virulence-associated fungal molecules relevant in the onset and evolution of infection. The researchers' ultimate goal is to identify new diagnostic and/or prognostic benchmarks useful in clinical settings. By combining serologic and immunologic expertise with clinical expertise, the research team has real potential to generate new markers of host pathogenesis and immune response in candidemia and to inform prospective clinical trials to control this terrible disease
In light of the controversy that are already approved but that however still exists regarding the efficacy and influence the management of Periodontitis, the aim of this study was to evaluates, at 6-months follow-up, the post-treatment clinical and serum parameters in patients with periodontitis, treated by either Full Mouth Scaling and Root Planing (FM-SRP) treatment versus conventional oral hygiene treatment on serum CRP and Growth differentiation factor-15 levels.
Randomized controlled study on the effectiveness of Telerehabilitation intervention on subjects with knee osteoarthritis. Subjects will be randomized into two groups. The experimental group perform 3 sessions a week for 4 weeks of TR, the control group 3 sessions a week for 4 weeks of conventional rehabilitation c/o IOR rehabilitation gym. Follow-up at 3 months. Inclusion criteria 1. Subjects must have a diagnosis of rheumatologic disease, osteoarthritis of one or more indications, OARSI criteria. 2. Male or Female, aged > 18 years 3. Participant is willing and able to provide informed consent for participation in the study. 4. Subjects must be able to use an electronic device (pc, tablet, smartphone). Exclusion criteria 1. Participation in another clinical study with any investigational agent within 30 days prior of the study screening. 2. Inability to use an electronic device (pc, tablet, smartphone) 4. Diagnosed with dementia or neurological disease that impairs speech comprehension e Not verbal. 5. Uncontrolled intercurrent illnesses including, without limitation, current infection or active, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illnesses/social situations that would limit compliance with study requirements, illnesses neurological. 6. Children under the age of 18 8. NPRS value <3 7. BMI >25
The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery - However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair. - The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation. Methods - Institutional database retrospective review for surgical mitral repair and MitraClip implantation. - Time frame: January 2012-December 2019 - 2793 patients identified; Euroscore II 1.3% [0.6%-2%] - Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure. Statistical analysis - Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test. - The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point. - ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.
Pain is an unpleasant sensation common to all those who undergo surgery. Several studies indicate that 40-60% of patients experience the post-operative experience and can be caused by both internal and external stimuli. The most patients define the post-operative experience as a very painful condition that interferes with normal daily activities. Chronic post mastectomy pain is a condition characterized by pain in the anterior chest, armpit, and/or upper arm, usually ipsilateral to surgery, which begins after mastectomy or quadrantectomy and persists for longer. three months after surgery. It can become chronic in a broad spectrum of conditions. In fact, it is estimated that between 10 and 50% of elective interventions can generate persistent post-surgical pain. Aim of this prospective observational study is to evaluate the effects of motor and/or sports activity on the intensity and interference of chronic pain in quality of life of women underwent mastectomy.
Groin pain represents a common issue in football. Currently, there are no prevention protocols demonstrating real effectiveness. We aimed to investigate the possible positive effect of a prevention program for groin pain.Forty-two élite male athletes belonging to a youth academy of a professional football club were recruited in this prospective, randomized, controlled, single-blind, study.
In this clinical trial, the investigators aim to examine the impact of a 12-week early time-restricted carbohydrate consumption diet on weight loss and glucose metabolism in patients with overweight/obesity and type 2 diabetes
The goal of this multicentric observational study was to compare four vitamin K dosing regimens in exclusively breastfed healthy term newborns. The main questions it aims to answer were: - comparing protein induced by vitamin K absence (PIVKA) levels in the different prophylaxis protocols at 48 hours, 1 month and 4 months - to investigate the compliance and safety of oral vitamin K 1 administration Participants received vitamin K prophilaxis according to birth Hospital regimen. A blood sample was taken at 48 hours, 1 month and 3 months of life. Plasmatic PIVKA-II concentretion was be dosed Researchers compared four groups of Vitamin K dosing regimens: 1. an intramuscolar injection of 1 mg vitamin K at birth 2. an intramuscolar injection of 1 mg vitamin K at birth followed by 50 μg/die orally from the second to the fourteenth week of life. 3. an intramuscolar injection of 1 mg vitamin K at birth followed by 150 μg/die orally from the second to the fourteenth week of life. 4. an oral dose of 2 mg vitamin K at birth, followed by a second dose at 4 weeks, and a third dose at 12 weeks to see if there is PIVKA-II plasmatic concentration differences.