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.
Partial assisted mechanical ventilation modes are widely used to manage respiratory failure. It has been demonstrated that they can reduce complications related to mechanical ventilation and neuromuscular blocking agents administration. During partially assisted ventilation, there is no predefined respiratory rate and the patient must trigger each breath. One of the most used partial assisted mode is pressure support ventilation (PSV), which plays a key role in weaning from mechanical ventilation, especially in neuro-cranial diseases. Neurally adjusted ventilatory assist mode (NAVA) has been introduced in clinical practice in recent years. It has been widely demonstrated that NAVA is able to guarantee gas exchange in the same way as PSV in patients admitted to ICU for respiratory failure. Thus, NAVA can improve patient-ventilator interaction reducing the incidence of asynchronous events and favoring the patient's own ventilatory pattern. Nevertheless, NAVA does not appear to have been applied in neuro ICU patients. In a study conducted on non-neurosurgical infants has been demonstrated negative effects of asynchronous events on cerebral blood flow velocities, examined with transcranial Doppler technique. In the present pilot study, the investigators would like to compare NAVA and PSV ventilation influence on cranial blood flow, evaluated with Trans-Cranial Color Doppler, in patients admitted to ICU for neurological injuries.
Assisted ventilation represents, nowadays, the preferred ventilation mode in clinical practice.It has been shown that assisted ventilation modes improve ventilation/perfusion matching, descrease risk of Ventilator induced lung injury and muscle atrophy and have less influence on haemodynamic function. However, PSV (Pressure Support Ventilation) is not free from complications: it may worsen or cause lung injuries by increasing alveolar and intrathoracic negative pressure and by loosing control on Tidal Volume (Vt). Indeed, it has been demonstrated that Vt is the main factor related to VILI. It has been shown that lower Vt and higher PEEP can improve clinical outcome only if associated with a simultaneous reduction in Driving Pressure. Increase in Driving Pressure resulted strongly associated with negative outcomes, especially if higher than 15 cm H2O. PSV is currently the most used assisted ventilation mode. NAVA (Neurally Adjusted Ventilatory Assist) is a ventilation mode in which the diaphragmatic electrical activity (EAdi) is used as a trigger to start a mechanical breath, applying positive pressure during patient's inspiration. Diaphragmatic electrical activity (EAdi) can be detected by a particular nasogastric tube (EAdi catheter). EAdi is the currently available signal closest to the neural breathing centers, which can estimate the patient's respiratory drive, if phrenic nerves are not damaged. It has been demonstrated that NAVA ventilation can reduce the incidence of patient-ventilator asynchronies, because the delivery of the support and the cycling between inspiration and expiration are completely controlled by the patient. However, although PSV and NAVA have been widely compared in many investigations, up to now there are no studies about driving pressure variation during these two modalities of mechanical assisted ventilation. The aim of this study is to measure changes in driving pressure at different levels of ventilatory assistance in PSV and NAVA ventilation modes. Secondary end points are respiratory mechanics indices and patient/ventilator related asynchrony evaluation and comparison.
Diabetic kidney disease (DKD) is a common complication of diabetes, and is now the most common form of chronic kidney disease. DKD is the leading cause of kidney disease requiring dialysis or kidney transplantation, and its global incidence and prevalence have reached epidemic levels. While the risk of developing DKD can be ameliorated by tight blood glucose and blood pressure control, it is not fully preventable and once established DKD cannot be cured. Therefore many patients are left with poor and worsening health and with increased mortality risk. Developing new ways to treat DKD requires healthcare professionals to be able to identify those patients most in need of treatment. One promising approach for identifying patients that are at risk is the use of imaging measurements (called "biomarkers") derived from Magnetic Resonance Imaging (MRI) and Ultrasound (US) of the kidneys. Evidence from early studies shows that such imaging biomarkers can identify underlying problems in DKD such as blood supply, oxygen supply, kidney scarring and kidney function, in ways that are better than those currently available. The investigators think that imaging biomarkers will improve the identification of patients who are likely to decline from DKD in the short term. The changes found by imaging may even happen before effects on the blood and urine. The investigators plan to test this hypothesis by performing a study observing 500 patients with early stage DKD, recruited in 5 sites across Europe. All patients will have detailed assessment at the start of their involvement, including clinical assessment, blood and urine samples, and MRI and US scans. The investigators will look at whether imaging biomarkers are associated with other measures that predict progression in DKD, and follow patients every year for 3 years (4 years total study participation) to see if the imaging biomarkers predict worsening DKD.
This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.
Lung adenocarcinoma with inactive LKB1 has emerged as a particularly aggressive form of lung cancer, with poor response to immune checkpoint inhibitors. Recent preclinical evidences have demonstrated that LKB1-inactive lung adenocarcinoma is characterized by specific metabolic vulnerabilities, which make it hypersensitive to energetic crisis. For instance, by inhibiting mitochondrial metabolism and reducing ATP availability to cancer cells, the antidiabetic compound metformin has anticancer activity and prevents acquired resistance to cisplatin in lung adenocarcinoma with inactive LKB1. Similarly to metformin, glucose starvation, which can be recapitulated in vivo by cyclic fasting or fasting-mimicking diet (FMD), can cause metabolic crisis in these neoplasms. In this trial, the investigators will assess for the first time the efficacy of combining standard-of-care platinum-based chemoimmunotherapy with metformin plus/minus FMD in patients with LKB1-inactive, advanced lung adenocarcinoma.
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's disease.
The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF. Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period. The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution. The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards. The Follow-up Period for subjects in both groups will be 90 days.
The general objective is to promote patient safety and quality improvement in critical care towards a significant reduction of observed mortality rates and economic costs through the improvement of outcomes and reduction of medical errors.
International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.