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.
Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of sucking-swallowing-breathing and better cardiorespiratory stability. The B-ESP group will be fed with a feeding system with a valved ergonomic teat; the B-STD with a standard feeding system.
Febrile urinary tract infections (UTIs) are common in children, but there is no consensus concerning the duration of the antibiotic treatment. Current recommendations include the use of an oral antibiotic, chosen between amoxicillin and clavulanic acid or a third-generation cephalosporin (ceftibuten), for a minimum of seven to a maximum of 14 days. In an antibiotic overuse-sparing model, proper evaluation of a shorter therapy in the treatment of febrile UTI in childhood is lacking. The objective of this randomized controlled trial is to assess the non inferiority of a five days oral course of amoxicillin and clavulanic acid vs the standard 10-day regimen in the treatment of febrile UTIs in children. The trial results might provide evidence of the non-inferiority of a short duration of the antibiotic course for the treatment of febrile UTI in childhood, contributing to a reduction in the over-use of antibiotics and consequently limiting the emergence of antibiotic resistance.
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups. Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine. Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants. If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.
One fourth of colorectal neoplasias are missed during screening colonoscopies-these can develop into colorectal cancer (CRC). In the last couple of years, Artificial Intelligence Deep learning systems were introduced in the endoscopic setting to allow for real-time computer-aided detection/characterization (CAD) of polyps with high- accuracy. Few CADe (detection) and CADx (diagnosis, characterization) have been therefore proposed with this purpose. Because CAD systems are based on deep learning where the computer directly learns polyp recognition from supervised data without any human-control on the final algorithm, their outcome incorporates some unpredictability in the clinical setting that must be cautiously interpreted after its application. This means that the endoscopist may be presented with FP images that he would have never been selected in the first place as suspicion areas. These FPs may hamper the efficiency of CADe-colonoscopy. Additional time may be required to discriminate between an actual FP and a possible false negative result. An excess of FPs may reduce the motivation of the endoscopist for CADe, leading to its underuse in clinical practice. Although the indications of a CADe must always be interpreted by physician, FP may result in unnecessary polypectomy with related adverse events when used without appropriate training. Yet, there is a lack of information among quantity and quality of False Positive signals provided by the systems. From a post-hoc analysis of a Randomized Clinical Trial, in which we extracted and analysed a video library of CADe-colonoscopy (GI Genius) performed in our institution Humanitas Clinical and Research Hospital IRCCS we aimed that False positives by CADe are primarily due to artefacts from the bowel wall. Despite a high frequency, FPs from this CADe system resulted in a negligible 1% increase of the total withdrawal time as most of them were immediately discarded by the endoscopists.
The aim of this study was to assess the efficacy of minimally invasive nonsurgical debridement (MINSD) of periodontal pockets with or without local amino acid buffered sodium hypochlorite (NaOCl) gel application after 6 months follow-up.
The primary aim of this study is the progress of the performance of the leader and of the team for the postpartum hemorrhage (PPH) before and after four high-fidelity standardized scenarios of severe PPH (1500 mL blood loss) due to refractory uterine atony with anesthesia trainees.
Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.
To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.
This prospective study evaluates the mechanisms of benefit of sacubitril/valsartan in a population of outpatients with heart failure with reduced ejection fraction, to investigate the relationship between the effects on left ventricular ejection fraction and volumes and noninvasively hemodynamic echo-derived parameters, as cardiac output and left ventricular filling pressure.
A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.