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.
Sepsis is the result of a complex pathological process which involves an intravascular inflammatory state, loss of vascular tone, endothelial injury, extravascular leakage, and often inefficient myocardial contractility. These affect the cardiovascular homeostasis as well as the regional perfusion and tissue oxygenation of patient. The importance of early cardiovascular support in septic patients is the reason why, for about fifteen years, the implementation of standardized resuscitation protocols has been emphasized. The Surviving Sepsis Campaign Guidelines (SSG) recommend an initial fluid resuscitation followed by use of a vasoactive agent such as norepinephrine for the treatment of patients with septic shock. To understand the impact of the hemodynamic support provided by the resuscitation strategy, the assessment of surrogate clinical parameters is pivotal. According to the current guidelines, the increase of mean arterial pressure (MAP) above 65 mmHg represents the threshold in defining patients as "stable". Although this strategy has been well established, its impact on the actual hemodynamic profile of the septic patient, remains a subject of ongoing controversy. In this scenario, the transpulmonary thermodilution technique (TPTD) allows invasive assessment of the patient hemodynamic profile in terms of fluid responsiveness, vasomotor status, or global cardiac efficiency. By using this technique, several studies highlighted a wide variability in the individual response of patients undergoing cardiovascular stabilization guided by SSG. This suggests that the implementation of a "customized" resuscitation protocol based TPTD derived parameters rather than resuscitation strategy guided by a fixed mathematic model, could be preferred. However, in daily clinical practice, the use of this advanced hemodynamic monitoring system in not routinely used, though it is often reserved in case of failure of the initial SSG-resuscitation protocol. The investigators supposed that, even if the initial resuscitative efforts were successful in achieving the SSG targets i.e. by restoring the MAP > 65 mmHg, this could still be inadequate in some patients. Accordingly, the investigators hereby will report the hemodynamic profile of patients with septic shock admitted in ICU.
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with SSc-ILD.
The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).
Diagnosis and characterization of neurodevelopmental disorders are considered challenging processes because of their complexity, multi-factoriality and heterogeneity. The present project will consider two of the most common neurodevelopmental disorders (i.e. autism spectrum disorders (ASD) and language disorders (LD)), with the aim to overcome these difficulties, by: a) deeply investigating their neuronal correlates; b) identifying multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c) developing a machine learning algorithm for early diagnosis. To achieve the above mentioned aims a multi-domain dataset will be used, comprising data collected from typically developing infants, infants at high risk for ASD and infants at high risk for LD. The data that will be used have been already collected within other trials performed at the Scientific Institute E. Medea.
Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab (RTX) (or its biosimilar)
To assess the safety, tolerability, biomarker, cognitive, and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug improves disease-related biomarkers and slows the rate of progression of cognitive or clinical impairment.
This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.
This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.
This is a national multicentre observational study with retrospective and prospective data collection to assess the time to hospitalisation of patients with a confirmed diagnosis of SARS-CoV-2 infection receiving treatment with anti-SARS-CoV-2 monoclonal antibodies. The subjects enrolled will be patients with early infection of SARS-CoV-2, paucisymptomatic, with risk factors for evolution to the severe form (according to AIFA criteria). Also, hospitalised subjects will be enrolled to receive SARS-CoV-2 monoclonal antibodies because of negative serology (according to AIFA criteria). It is estimated to enrol about 1000 subjects. Patients will be evaluated at enrollment and 28 days following administration to collect data on symptoms, possible hospitalization and final clinical outcome (alive with symptoms, alive without symptoms, alive with symptoms and hospitalized or deceased). Data will be collected using a dedicated electronic Case Report Form (eCRF).
The present study will mainly aim to review and characterize the pathologic features, treatment options, and follow-up outcomes of women with in situ/microinvasive adenocarcinoma of the uterine cervix according to HPV status (positive versus negative high-risk HPV). It will evaluate the impact of HPV status on the recurrence and survival during a follow-up of five years. The present study will be a multi-institutional study including several oncological Italian Centers. Data will be retrospectively collected from January 2012 to December 2016 with a total follow-up of 5 years.