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 randomized controlled clinical trial (RCT) was to investigate the clinical and biochemical efficacy of a gel containing PDRN and HA used in association with subgingival re-instrumentation in the treatment of residual periodontal pockets.
With the prevalence of obesity soaring and the absence of an effective and safe treatment that is low-cost and always feasible, the use of food supplements has gained attention for the potential benefits in the absence of significant safety concerns. Cinnamon (CC) and Withania somnifera (WS) are plant-based supplements reported to be effective in improving metabolic health and body composition, the first mainly acting on insulin resistance and the second on energy expenditure and leptin resistance, as shown in preclinical and some clinical studies. Their association, possibly synergistic leveraging different mechanisms of action, has never been studied. This was a double-blind placebo-controlled study. Patients with overweight or obesity were prescribed a mildly hypocaloric diet with CC 300 mg plus WS 150 mg tid for 4 weeks in a cross over design and anthropometric parameters together with safety outcomes were collected.
Purpose Functional tricuspid regurgitation (FTR) has been shown to be associated with increased morbidity and mortality in several clinical conditions, including heart failure (HF) with reduced left ventricular ejection fraction as well as pulmonary arterial hypertension (PAH). We have designed a study aiming at: characterizing the echocardiographic morphology of the tricuspid valve apparatus and the pathophysiology of FTR in heart failure with reduced, mid-range or preserved left ventricular ejection fraction (HFrEF, HFmrEF, HFpEF) and in PAH patients; correlating the morphologic characteristics of tricuspid valve apparatus with hemodynamic severity of FTR; correlating the severity of FTR with the clinical condition and outcome. Methods The study will be a non-interventional, prospective, international, multicenter, longitudinal study. The minimum number of patients which are expected to be enrolled is 300 HF patients, including HFrEF, HFmrEF and HFpEF patients, whereas 100 PAH patients will serve as control. The patients will be enrolled in 20 centers in Europe, North America and Saudi Arabia. The echocardiographic parameters will be analyzed by the local investigators; a quality control committee will evaluate all data entered in the database to identify potential outliers and a random sample of 10% of cases will be blindly re-analysed in a central core-lab. Conclusions This study has been designed to improve our understanding of pathophysiological mechanisms and clinical relevance of FTR across all HF phenotypes. The results could potentially allow a more appropriate selection of heart failure patients with FTR for tricuspid valve intervention by percutaneous or surgical repair or replacement.
Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation
This study will test the safety of a drug called SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have four parts. Parts A and B of the study will find out how much SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D, participants will be given SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.
The role of WB-MRI in the evaluation of prostate cancer patients treated with Lu-PSMA
This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner.
Stroke is responsible for about 7% of disabilities in the European population. Intracerebral hemorrhage (ICH) represents 15% of stroke cases in Europe. In order to avoid disabling sequelae, an essential role is played by early rehabilitation, which has also proved effective for ICH. In addition to its role in physical recovery, it plays a fundamental role in the psychological well-being of patients with ICH. Impairments in trunk function are a common sequela and are related to reduced mobility, balance and functional independence. Trunk exercises could improve trunk control, postural control, and functional recovery. The hypothesis is that a specific exercise program, based on core stability, will induce clinically significant and long-term improvements from the point of view of trunk control, and secondly in postural control, disability and quality of life in subjects with hemorrhagic stroke outcomes, versus general physiotherapy, and that these improvements will be maintained at least one year after the intervention.
This is a 12-month, parallel treatment, Phase 3, double-blind, randomized, placebo controlled study to evaluate the effect of venglustat on neuropathic and abdominal pain symptoms of Fabry disease in participants ≥16 years of age with Fabry disease who are treatment-naïve or untreated for at least 6 months. - Study visits will take place approximately every 3 months. - The double-blind period will be followed by an open-label extension (OLE) during which participants who have completed the double-blind period will be treated with venglustat for up to an additional 12 months.
The goal of this study is to determine how a structured and supervised physical activity program linked to Dragon Boat practice can improve motivation to participate in physical activity sessions. It is also the purpose of this study to evaluate the improvement in body composition, body image perception and physical function. For this purpose, a group of women operated on for breast cancer was recruited and divided into two experimental groups: one group participated in a structured program of Dragon Boat while the other followed a home-based program of exercises independently in the home environment. Anthropometric measures (weight, height, BMI) and arm circumference, data on lifestyle and psychological well-being were evaluated by means of questionnaires. Tests were also performed to assess shoulder strength, aerobic capacity and mobility. The results of this study will (a) identify the strategies used that make Dragon Boat activity effective in ensuring quality participation in physical activity, (b) define the physiological effects of Dragon Boat activity on physical functionality and (c) correlating objective measures with subjective perceptions thanks to the integration of new body composition analysis techniques (regional BIA) and validated questionnaires on the perception of body image.