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.
Primary objective: to evaluate the predictive role of Prediction Score on the risk of developing venous thromboembolism in patients with liver cirrhosis admitted to non-surgical wards. Secondary objectives: - To estimate the prevalence and incidence of venous thromboembolism in patients with liver cirrhosis admitted to non-surgical wards - To calculate the prevalence in the same subset of patients of major bleeding (defined as bleeding resulting in the patient's death, a drop in hemoglobin > 2g/L, the need to transfuse > 2 units of packed red blood cells or bleeding into a critical organ/space including the intracranial, retroperitoneal, intraocular, adrenal, spinal, pericardial districts) related to the application or not of thromboprophylaxis measures (pharmacological and mechanical) Study design: The study is single center and it will be divided into two parts, a first retrospective part and a second prospective case control study. Methods: adult patients with liver cirrhosis admitted in Internal Medicine and Gastroenterology Unit of Policlinico Agostino Gemelli will be enrolled in the prospective study. For the retrospective part of the study, data about cirrhotic patients hospitalized in non-surgical departments of Policlinico Agostino Gemelli will be collected. Exclusion criteria will be hospitalization in surgical wards or intensive care units, patients with active bleeding at the time of admission, patients hospitalized for liver transplantation, anticoagulant therapy at therapeutic dosage at the time of admission for indications other than liver cirrhosis (e.g. personal history of thromboembolic events, atrial fibrillation/flutter or mechanical heart valves), contraindications to anticoagulant prophylaxis (recent or ongoing bleeding, creatinine clearance assessed by EPI-CKD method < 15 ml/min, platelet count < 50 x 10^9/L), patients hospitalized as elective regimen to perform invasive procedures that contraindicate anticoagulant prophylaxis (e.g. liver biopsy, local treatment of liver neoplasms, ligation of oesophageal varices), double antiplatelet therapy, pregnancy
According to international guidelines, Hepatic Venous Pressure Gradient is the gold standard technique for portal hypertension measurement, but it is invasive and poorly available. Currently, surveillance of oesophageal/gastric varices is performed by upper gastrointestinal endoscopy. More recently, non-invasive tools to estimate portal hypertension have been developed and, among them, ultrasound elastography has been proposed as a technique to stratify patient risk to have portal hypertension. Aim of this study is to evaluate the relationship between ultrasound evaluation (D-CEUS + elastography) and endoscopic parameters predictive of clinically significant portal hypertension in patients with liver cirrhosis.
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetic (PK) profile of prophylactic SerpinPC in participants with Hemophilia B with inhibitors, as part of the SerpinPC registrational program.
The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of prophylactic SerpinPC administered subcutaneously (SC) to participants with severe hemophilia A (HemA) (with or without inhibitors) or moderately severe to severe hemophilia B (HemB) (without inhibitors) as part of the SerpinPC registrational program. This study consists of 3 parts: Part 1: dose-justification phase, Part 2: dose-confirmatory phase, Part 3: extension phase for participants who complete either Part 1 or Part 2. This adaptive design study has a randomized dose-justification component to investigate the efficacy and safety of SerpinPC as a therapeutic option, principally for participants with HemB without inhibitors. SerpinPC has a novel mechanism of action compared with marketed treatments and those that are in development.
Several studies have shown that alterations in autonomic nervous system function are implicated in the onset and progression of numerous cardiovascular diseases. Direct stimulation of the vagus nerve by means of a sleeve placed around the vagus nerve represents one of the methodologies proposed in the field of neuromodulation. This study, which is proposed as a pilot study for further application of the method in subjects with cardiovascular disease aims to verify and consolidate evidence on cardiovascular autonomic effects in patients with heart failure. Vagal stimulation will be achieved noninvasively by applying an external stimulator to the auricular site.
The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).
The purpose of this study is to test the safety and tolerability of HFB200603 as a single agent and in combination with tislelizumab in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses of HFB200603 as a monotherapy or in combination with tislelizumab until a safe and tolerable dose of HFB200603 as a single agent or combination therapy is determined. During the expansion part, participants will take the doses of HFB200603 as a monotherapy (optional arm) or in combination with tislelizumab that were determined from the escalation part of the study and will be assigned to a group based on the type of cancer the participants have.
The aim of the CORONA.BOT project is to exploit the Artificial Intelligence methods of Generator Real World Data Facility to automatically extract structured and unstructured data from hospital databases and to implement an early risk assessment (warning system) regarding the negative outcome for patients infected with SARS-CoV-2. The objective of CORONABED.BOT is to analyze the care pathways of patients from the same cohort as CORONA.BOT, in order to identify the total length of stay, intensive care occupations and flows between departments, based on variables demographics and first entry clinics Early identification of patients with symptoms compatible with SARS-CoV-2 infection will enable more rapid activation of isolation procedures, contact monitoring/contact history and decisions on the most appropriate clinical pathway in terms of type of treatment and unit. Similarly, the identification of factors correlated with worse outcomes will allow more effective planning for the use of critical resources (such as intensive care and others).
Sepsis is a life-threatening condition, caused by a systemic infection. It is particularly dangerous in already fragile populations and needs to be identified quickly to be treated as fast as possible, as discussed during the 2016 sepsis consensus and highlighted by the 2021 Surviving Sepsis Campaign. Yet, while there are scores to quickly identify patients who are at an increased risk of mortality (namely quick-SOFA, q-SOFA), these scores are also highly unspecific and cannot guarantee an adequate risk stratification. Therefore, it would be extremely valuable to further stratify mortality risk in patients who present to the emergency medical evaluation, especially those who present with stable hemodynamics but are at increased risk of decompensation during hospital stay. Furthermore, in the emergency room, it is sometimes impossible to re-evaluate patients regularly, thus, it would be important to immediately identify high-risk patients. Unfortunately, at the moment, there is no consensus. Through this study, the investigators will try to identify ultrasound parameters and biochemical markers which can be obtained during the first visit in the emergency room (ER) and that allow a quick risk stratification of patients with sepsis. The rationale of this study is to improve early identification of septic patients who are at risk of rapid deterioration in the course of their permanence in the ER and the hospital wards in general. The investigators selected a number of clinical, laboratory and bedside ultrasound parameters which have been previously shown to be correlated with mortality in sepsis, and will seek to identify which among these parameters best correlates with prognosis when acquired in the very first minutes of a patient's arrival in the ER. The objective would be to analyse these parameters and eventually to propose a new early sepsis score which might help the emergency physician to better tailor its efforts and clinical resources to the most sick patients.
Constipation is a frequently encountered problem in childhood, with a prevalence ranging between 1 and 30%. Several studies have proposed pelvic ultrasound, (simple, non-invasive and reproducible) both to define the presence of megarectum, and to follow the answer to treatment, but the real utility remains to be defined, especially in the follow-up.The primary aim of the study is to evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.