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.
Background: antibiotic-associated diarrhoea (AAD) is defined as an acute inflammation of the intestinal mucosa associated to the administration of antibiotics. Its aetiology seems to be linked to the impact of antibiotics on the normal digestive microbiota. Acute otitis media (AOM) is a common paediatric condition and it is one of the most commonly cited indication for antimicrobial therapy in children (amoxicillin + clavulanic acid). Treatment modalities for AAD are limited because no established treatment exists for non-Clostridium difficile associated AAD, except for discontinuing antibiotic therapy. Measures to prevent AAD include the use of probiotics. The rationale for the use of probiotics in AAD assumes that, considering the pathogenesis of AAD, AAD is associated with disturbance in the normal intestinal microbiota; administrating specific probiotic strains it is possible to normalize unbalanced indigenous microbiota. Scientific evidence suggests that prebiotics could be beneficial too. Prebiotics can act in synergy with probiotics, being efficacious in suppressing the growth of pathogenic bacteria that may occur during antibiotic therapy. Study rationale: the principal side effects of treatment with amoxicillin-clavulanate include diarrhoea, vomiting and allergic reactions. Aim of this study is to evaluate the effectiveness of the administration of a synbiotic product, Bio-Kult Infantis®, in the prevention of AAD during a standard therapy with amoxicillin-clavulanate to treat AOM. Objective: to evaluate the effectiveness of a synbiotic product in the prevention of Antibiotics-Associated Diarrhoea (AAD) during a concomitant standard therapy with amoxicillin / clavulanic acid, also known as co-amoxiclav, to treat Acute Otitis Media (AOM). Study design: this is a multicenter, double blind, parallel group, placebo controlled, randomized clinical study. 276 children 6 - 35 months old will be enrolled and then randomized into one of the two study groups (Bio-Kult Infantis® + co-amoxiclav standard treatment for AOM / placebo + co-amoxiclav standard treatment for AOM). A comparison will be performed to evaluate the effectiveness of a synbiotic product in the prevention of AAD during the concomitant standard therapy with co-amoxiclav. During the study 4 visits will have to be performed at the study centre, and extra visits will be performed in case of AOM relapse after recovery. The study will last for each patient 38 ± 6 days.
A cross-sectional prospective study of follow-up in gynecologic cancer patients after primary treatment
The purpose of this study is to evaluate the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab (MK-3475; KEYTRUDA®) in the treatment of adults with the following types of tyrosine kinase inhibitor (TKI)-resistant, epidermal growth factor receptor (EGFR)-mutated, metastatic non-squamous non-small cell lung cancer (NSCLC) tumors: 1) TKI-failures (including osimertinib [TAGRISSO®] failure) with T790M-negative mutation tumors, 2) T790M-positive mutation tumors with prior exposure to osimertinib, and 3) first-line osimertinib failure regardless of T790M mutation status. The primary study hypotheses are that the combination of pembrolizumab plus chemotherapy has superior efficacy compared to saline placebo plus chemotherapy in terms of: 1) Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review, and 2) Overall Survival (OS). This study will be considered to have met its success criteria if the combination of pembrolizumab plus chemotherapy is superior to saline placebo plus chemotherapy in terms of PFS or OS. Upon study completion, participants are discontinued and may be enrolled in a pembrolizumab extension study, if available.
The objectives of this prospective, two-arm, multicenter post-market study is to confirm safety and performance through the incidence of subjects reporting serious adverse device effects (ADEs) up to and including 30 days following use of Signia™ Stapling System with Endo GIA™ with Tri-Staple™ Technology and Tri-Staple™ 2.0 Intelligent Reloads in subjects undergoing indicated abdominal or thoracic procedures for resection, transection and creation of anastomosis per the IFU.
The primary objective of the study is to compare the progression-free survival (PFS) of REGN2810 (cemiplimab) plus ipilimumab combination therapy (hereinafter referred to as REGN2810/ipi) and REGN2810 plus 2 cycles only of platinum-based doublet chemotherapy plus ipilimumab combination therapy (hereinafter referred to as "REGN2810/chemo/ipi") with standard-of-care pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC) whose tumors express programmed death ligand 1 (PD-L1) in ≥50% of tumor cells. The key secondary objectives of the study are to compare the overall survival (OS) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells and to compare the overall response rate (ORR) of REGN2810/ipi and REGN2810/chemo/ipi with pembrolizumab monotherapy in the first-line treatment of patients with advanced squamous or non-squamous NSCLC whose tumors express PD-L1 in ≥50% of tumor cells.
The primary objective of this study is to compare the efficacy of treatment with HFNC (group A) compared to administration of oxygen therapy by Venturi mask (group B, standard therapy) in terms of reaching of endotracheal intubation criteria during acute respiratory failure due to severe pneumonia. Inclusion Criteria: Respiratory rate (RR) at rest ≥20 bpm or presence of respiratory distress (severe dyspnoea at rest or use of accessory respiratory muscles or abdominal paradox); PaO2 / FiO2 ≤250 during oxygenation with Venturi Oxygenation mask at FiO2 = 50% administered for at least 60 minutes; Diagnosis of pneumonia as the sole cause of acute respiratory failure. Randomization: 150 consecutive patients will be randomized either to High Flow Nasal Cannula Oxygenation (75 patients, HFNCO with flow ≥ 60 L/min and FiO2 to maintain SpO2 ≥ ) or Venturi Mask Oxygenation (control, 75 patients). Patients from both groups will be treated with antibiotic therapy according to the IDSA/ATS 2007 guidelines for community-acquired pneumonia and the IDSA/ATS 2016 guidelines for hospital-acquired pneumonia. Intubation Criteria: MAJOR CRITERIA: Cardiac or respiratory arrest Breathing pauses with loss of consciousness Severe hemodynamic instability Need for sedation MINOR CRITERIA (maintained for ≥1h): Reduction ≥30% of the value of the PaO2/FiO 2 compared to baseline Increased 20% if PaCO2 PaCO2 previous ≥40mmHg Worsening alertness as increased by one degree on the Kelly scale Persistence or onset of respiratory distress Vital parameters, Kelly scale and arterial blood gas analysis (BGA) will be performed on admission, and at 1, 24, at 48 hours, at the achievement of clinical stability, and whenever there is a clinical worsening. Patients enrolled in HFNC arm will continue HFNC oxygenation until clinical stability, defined as: Body temperature ≤ 37°C and ≥36°C for 24 consecutive hours Good ability in swallowing CRP and WBC normalization trend than the admission exams Hemodynamic stability Lack of respiratory distress SpO2 94-98% The primary outcome variable is the proportion of patients who reach the endotracheal intubation criteria - regardless of the actual intubation rate - within the first 48 hours of treatment. The primary analysis will be performed on the ITT population
The purpose of this study is to evaluate the efficacy beyond progression of vemurafenib combined with cobimetinib associated with local treatment compared to second-line treatment in patients with BRAFV600 mutation-positive metastatic melanoma in focal progression with first-line combined vemurafenib and cobimetinib.
The purpose of this study is to evaluate the safety and preliminary antitumor activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy.
This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic cancer in the lung. Patients who have consented to participate in this study (enrolled) will be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C procedure. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment. Patients will be followed for up to 12 months.
Patients undergoing orthodontic treatment with fixed appliances usually develop gingival enlargement (GE). Its development is usually attribute to chronic inflammation, and may cause both esthetic and functional problems for the patient. In many cases, the gingival hyperplasia demands periodontal surgery in order to increase the length of the crown during or after the orthodontic treatment. Previously conventional surgical procedures were performed using a scalpel under local anaesthesia for these procedures. Lately the use of laser has been proposed. The majority of the studies comparing laser gingivectomy with scalpel gingivectomy show some limits: they are not randomized, they are not prospective, and they have no control group. The primary objective of the present investigation was to conduct a randomized controlled trial (RCT) evaluating the effectiveness of diode laser gingivectomy versus scalpel gingivectomy in the management of periodontal health among patients receiving fixed orthodontic appliance therapy, compared with a non surgical control group.