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.
Robust detection of single molecules in complex biological fluids is the ultimate goal in the field of disease biomarker analysis. Conventionally, to enable the quantitative analysis of individual molecules in macroscopic volumes, analyte pre-concentration and sample partitioning into fL-nL compartments has been combined with the amplification of the specific recognition events. In these setups, the positive or negative detection of fluorescence signal is triggered by enzymatic reactions occurring in each compartment. Binary readout based on Poisson statistics quantifies ultra-low concentrations of analyte molecules. This approach has been adopted for nucleic acids analysis in current digital PCR, and is also available for proteins in a technique coined as digital ELISA. The objective of VerSiLiB is to develop an enzyme-free amplification strategy for the analysis of both protein and nucleic acid analytes with the single digital platform that offers means to access additional information on target analytes not achievable with current technologies. Method is based on novel affinity-mediated-transport amplification, where affinity interaction of target analyte with a specific ligand attached to a magnetic nanoparticle transporter is accompanied with rapid shuttling of fluorescent tracers that serve as reporters. By applying external magnetic field, tracers are transported from the tracer storage side (where they are dark) to tracer active side (where they become bright) only if target analyte is present in the small reaction compartment. Tailored plasmonic nanostructures will be prepared at the storage and active sides of the compartment to render the tracer either dark or bright. The aim is to perform technology validation for the novel VerSiLiB proteogenomics amplification platform in cancer management using biobanked liquid biopsy samples.
The aim of this study is to explore the anti-inflammatory and neuroprotective effects of a novel nutraceutical product (commercial name Forza™️), consisting of the plant osmotin protein, in patients with progressive multiple sclerosis (PMS). The potential effect on brain metabolism and microstructure will be evaluated by magnetic resonance imaging (MRI) performed six months before starting treatment, at baseline, and after one and six months of treatment. At the same timepoints, electrophysiology, neurofilaments (NfL) quantification, optical coherence tomography (OCT) and clinical assessments will be performed.
The goal of this clinical trial is to: - Prospectively investigate the association of Adenomyosis with fertility outcomes in relation to COH protocols for ART (long or ultra- long protocol) with a preventive high-dose anti-inflammatory progestin such as DNG and to assess their association with pregnancy and neonatal outcomes (preterm delivery,pre-eclampsia,Caesarean section,fetal malpresentation,small for gestational age,low birth weight and postpartum hemorrhage). - Understand how the endometrial interface by studying the response of progesterone and DNG stimulated decidualization markers, correlating them with the success of ART protocol stimulation and to pregnancy specific outcomes - Evaluate the immune changes during the implantation period and in the different trimesters of the pregnancies after ART conception.
Postoperative delirium is a common complication that usually occurs acutely within the first 24 hours after surgery and resolves within 72 hours; it is common in all medical areas and particularly affects patients over the age of 65 and those with pre-existing cognitive impairments. It is characterized by difficulty organizing and coordinating thoughts and by slowing down motor functions that are observed for a short period after surgery. The study will be an observational prospective study with historical control (pre/post-study) whose primary objective is to identify the incidence of postoperative delirium in patients undergoing cardiac surgery. The population will be adult patients undergoing cardiac surgery at our University Hospital over a period of 12 months. The intervention will be exposure to totally artificial light (for patients hospitalized after the relocation of the department to its original location). The comparator will be exposure to natural light (for patients who will be hospitalized during our temporary transfer to an environment with natural lighting). The outcome will be the incidence of delirium, measured with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) scale; episodes of agitation requiring sedative drugs; time elapsed before onset of delirium. The study will last 12 months.
Patients with prostate cancer who are candidates for stereotactic radiotherapy to the prostate and seminal vesicles will undergo staging exams which will include prostate specific memrane antigen (PSMA) positron emission tomography-computed tomography (PET-CT). If the PET scan is negative and the uroflowmetry is acceptable, the patients will perform the treatment, after fiducial implantation, simulation CT and magnetic resonance (MR), in a single fraction, delivered with an high-dose-rate (HDR)-like urethral sparing technique. In 70 patients acute and late toxicity, biochemical control, overall, cancer specific survival and quality of life with specific questionnaires will be evaluated.
This clinical study wants to evaluate the efficacy and safety of a medical device combining "Polynucleotide Highly Purified Technology" (PN-HPT™) and hyaluronic acid (Newest-Mastelli S.r.l) for treating moderate-to-severe atrophic post-acne scars.
This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
The goal of this observational study is to explore inter- and intra-individual determinants of postprandial glucose response in patients with type 1 diabetes using continous glucose monitoring (CGM). A blood glucose sample will be collected during hospital visit. Participants will be asked to: - record a seven-day food diary - complete EPIC food frequency questionnaire - collect a stool sample.
The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will lasts around 31 weeks.
This observatory aims to collect, as widely as possible, the Italian cases of patients with uncontrolled CRS. Patient will be enrolled by the centers of the Italian Network of Rhinosinusitis (Rhinosinusitis Italian Network: RINET), and they will be treated using a multidisciplinary team approach (allergists, otolaryngologists and pneumologists) in a real-world clinical set-up. This real-life chronic rhinosinusitis registry aims at longitudinal data collection from patients attending specialist care centres across Italy.