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.
International guidelines for pulmonary rehabilitation describe pathways dedicated to moderate COPD patients looking at the work setting, programs and frequency of training sessions in an outpatient program of rehabilitation. However, a new population of respiratory patients is growing: these are more serious and older patients, with several comorbidities and recurrent hospitalizations. In this population no guidelines are available to describe the optimum prescription in terms of frequency, intensity, type and timing (FITT) of rehabilitation. In this kind of patients, only few studies are available on the overtraining risk. The aims of the current study are: 1. To detect and compare the response in terms of endurance of two endurance training programs with different time-frequencies (1 session / day versus 2 sessions / day) during 30 days of in-hospital admission to a pulmonary rehabilitation center 2. To compare the effectiveness in terms of effort tolerance, dyspnea, peripheral and respiratory muscle strength, quality of life and psychological and functional impact of the disease.
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (CE-DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were scheduled for coronary angiography.
The purpose of this study is to evaluate the safety and performance of the MANTA Vascular Closure Device (VCD) to close the arteriotomy following percutaneous cardiovascular procedures utilizing large bore sheaths for purposes of supporting a CE Mark (Conformite Europeenne--"European Conformity") and other regulatory submissions. The study will assess whether the MANTA VCD is safe and performs as intended for large-bore vascular closure after interventional procedures.
Drg-drug Interaction (DDI) study to assess the effect of INC280 on the pharmacokinetics of midazolam and caffeine in patients with cMET-dysregulated advanced solid tumors
Red raspberries are a rich source of (poly)phenolic compounds, the main components being anthocyanins and ellagitannins. There is growing evidence linking consumption of these compounds with beneficial effects on human health. However, the mechanisms involved remain poorly understood principally because of a limited understanding of the bioavailability of ellagitannins and anthocyanins. This study aims to explore the identity and amounts of the phenolic metabolites of anthocyanins and ellagitannins in human plasma and urine following acute ingestion of raspberries. For this purpose ten healthy volunteers were feed 300 g of blended raspberries containing in total 293 μmol anthocyanins and 250 μmol ellagitannins. All urine excreted over 48 h after the ingestion of raspberries was collected and blood samples were collected before (0 h) and after raspberry consumption up to 24 h. Metabolites were identified and quantified by ultra high performance liquid chromatography-mass spectrometry (UHPLC-MS).
Needle-related procedures are among the most common sources of pain and distress for children in the health care setting. More than 50% of children reported pain during these procedures. The necessity for pain management during these procedures is well established. Topical anesthesia has been shown to be effective in managing needle-related pain. Eutectic mixture of local anaesthetic (EMLA) cream is the topical anesthetic most used. The application of this mixture of lidocaine and prilocaine reduce pain during needle procedures in children. To be effective EMLA cream must be applied for at least 60 minutes before needle procedure. This is the major limitation for its use in emergency settings. Ralydan patch is a drug delivery system designed to release local anaesthetics (lidocaine and tetracaine) through the skin. There is evidence of pain relief after 30 minutes from its application. Only one randomized controlled trial compared the two topical anaesthetics in children during venipuncture and showed that Ralydan patch led to superior analgesia than EMLA cream, even if in this study the two anaesthetics were applied only for 35 minutes before needle procedure. No differences were found in success rate of the procedure and vein visibility. In adult patients, Ralydan and EMLA were equally effective in pain relief after 60 minutes from application. To the best of the investigators' knowledge there is no published study that compared needle procedure success rate in children and pain relief effectiveness of lidocaine/tetracaine patch and lidocaine/prilocaine cream, at time of their maximum analgesic effect. The aim of this study is to compare Ralydan patch and EMLA cream at time of their maximum analgesic effect (30 minutes vs 60 minutes), regard to needle procedure success rate at the first attempt and pain relief in children.
This is an investigator-initiated, prospective, single-centre, randomised, phase II, open-label study, testing the superiority of ticagrelor, as compared to clopidogrel, in modulating on-P2Y12 treatment platelet reactivity, endothelial dysfunction and inflammation in chronic obstructive pulmonary disease (COPD) patients receiving scheduled percutaneous coronary intervention (PCI) for stable coronary artery disease. Subjects that meet the inclusion criteria and have provided informed consent will be randomly assigned in a 1:1 fashion to one of the two dual antiplatelet therapy (DAPT) regimen: aspirin + clopidogrel (standard of care) vs. aspirin + ticagrelor (experimental arm). DAPT with aspirin and clopidogrel for at least 6 months (preferably 12 months) is the current gold-standard for patients receiving PCI and drug eluting stent implantation for SCAD. No data supports a different strategy and/or approach in COPD patients undergoing PCI. Ticagrelor, a new P2Y12 inhibitor, showed a significantly higher platelet inhibition as compared to clopidogrel. Recently, ticagrelor administration has been associated with a positive effect on endothelial function and a modulation of proinflammatory signalling. These actions are mediated by a significant influence of adenosine uptake. Higher platelet reactivity, chronic inflammatory response, heightened endothelial dysfunction characterized COPD patients with concomitant coronary artery disease (CAD). The investigators speculated that COPD patients undergoing PCI for stable CAD (SCAD) had a risk profile similar to that of acute coronary syndromes (ACS) patients. Accordingly, COPD patients undergoing PCI for SCAD may obtain a stronger benefit by ticagrelor as compared to clopidogrel. The aim of this study is to evaluate whether ticagrelor, is superior to clopidogrel, in reducing endothelial dysfunction , platelet reactivity (PR) and inflammation profile of patients with stable CAD and COPD. Ticagrelor will be administered according PLATO trial and international guidelines (180 mg as loading dose, 90 mg x 2 daily as maintenance dose). As suggested by international guidelines, the control group will be patients with current gold standard treatment for SCAD treated with PCI (aspirin + clopidogrel 75 mg daily). The evaluation of endothelial dysfunction, PR and inflammation profile will be repeated after 30 days and will be compared to baseline values.
Prospective exploratory study specifically investigating the diagnostic and predictive role of 11C-Choline PET/CT and DWI MRI for response assessment in patients affected by HCC and candidate to TARE. A minimum number of 20 patients will be considered for the analysis.
This is a retrospective study that involves the revision of clinical, instrumental and pathologic data of an estimated cohort of maximum 130 patients with NSCLC treated with surgery with radical intent at our center.
Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.