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.
The aim of this prospecive randomized study is to evaluate the effects of a dose of sugammadex increased by 50% compared to a standard dose on recovery time from deep neuromuscular block in elderly patients undergoing robot-assisted laparoscopic radical prostatectomy (RALP). Secondary objectives are to evaluate the different extubation time, time to exit from the operating room (OR), lenght of stay in post-anaesthesia care unit (PACU) and safety (hemodynamic parameters and respiratory function).
The newly recognised disease COVID-19 is caused by the Severe-Acute-Respiratory-Syndrome Coronavirus 2 (SARS-CoV-2), which rapidly spread globally in late 2019, reaching pandemic proportions. The clinical spectrum of SARS-CoV-2 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness and mild extrapulmonary symptoms, and severe viral pneumonia with respiratory failure and even death. Given the rising global death toll associated with the pandemic, in the last year we have witnessed a race to find drugs/biological treatments to save the lives of hospitalised, severely ill patients, as well as to develop vaccines. Nonetheless, to limit the number of hospitalisations and deaths due to severe illness, thus avoiding pushing hospitals to their limits and remarkably reducing the tremendous treatment costs for health care providers, it is crucial to also focus on primary care physicians and initial mild symptoms in COVID-19 patients at home. As with other acute viral infections, early initiation of treatment for COVID-19 might improve clinical outcomes. For COVID-19, most primary care physicians have initially treated their patients according to their judgment, with various treatment regimens they believe are most appropriate based on thier experience/expertise. We recently published a note on how we were treating patients at home based on the pathophysiologic and pharmacologic rationale and the available clinical evidence of efficacy in COVID-19 for each of the recommended class of drugs. Because the common early mild symptoms of COVID-19 highlight a systemic inflammatory process, there is the recommendation of using anti-inflammatory agents to limit excessive host inflammatory responses to the viral infection, including non-steroidal anti-inflammatory drugs and corticosteroids. In a recent academic matched-cohort study, we found that early treatment of COVID-19 patients at home by their family doctors according to the proposed recommendation regimen almost completely prevented the need for hospital admission (the most clinically relevant outcome) due to progression toward more severe illness, compared to patients in the 'control' cohort who were treated at home according to their family physician's assessments. This translated into a reduction of over 90% in the overall numbers of days of hospitalisation and in related treatment costs. Treatment according to the recommended algorithm was safe and well tolerated. However, the rate of hospitalization was a secondary outcome of the study and the possibility of a casual finding cannot be definitely excluded. Thus, we have considered the observed reduction in patient hospitalization an hypothesis generating finding that provides a robust background for the present new cohort study primarily aimed to test the effect on this outcome of COVID-19 treatment at home according to the proposed recommendation algorithm. No randomized clinical trials have been performed so far in COVID-19 patients to compare the effectiveness of different regimens targeting early symptoms at home. Comparative analysis of patient cohorts with long-enough follow-up in everyday clinical practice may offer a good alternative to randomized clinical trials to evaluate effectiveness of therapeutic interventions. Thus, we will use this approach to compare a cohort of COVID-19 patients treated at home by their family physicians according to the proposed recommendation algorithm with another cohort of similar COVID-19 patients treated by their family doctors with various treatment regimens they believe most appropriate based on their experience and expertise, and monitored longitudinally up to 3 months. Our working hypothesis is that following the proposed recommendation algorithm the early COVID-19-related inflammatory process is limited, preventing the need of hospital admission at larger extent than with other therapeutic approaches also targeting early symptoms of the illness at home.
For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life. There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction. Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes. As a consequence, plastic surgeons come into contact with more patients with a history of irradiation of their breasts than ever before. However, there are few studies with a significant number that evaluate the effect of pre-reconstruction radiotherapy on the three types of reconstruction. The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the impact of breast prior irradiation on the outcome of prosthetic reconstruction.
Olfactory dysfunction is common among patients with Corona-Virus-Infection-Disease (COVID)-19, and up to 30% of patients may report persistent disorders of smell or taste as a long-term sequelae. This randomized-controlled study has addressed to compare the efficacy of neuro-protective and anti-inflammatory agents palmitoylethanolamide (PEA) and Luteolin(Treatment) with control (olfactory training) in a cohort of patients who present persistent smell disorders after resolution from Covid-19 and negative swab for 4 months at least.
It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.
It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection). Constant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.
To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.
Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation with Vertistop® D (food supplement containing alpha-lipoic acid at modified release, Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing fast releasing alpha-lipoic acid, Carnosine, Zinc and Curcumin) in preventing recurrence of high-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week, or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. Participants will also get a mealtime insulin. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
This is a retrospective, multinational, non-interventional, observational study. A series of cohort studies will be conducted to assess the prevalence of undiagnosed stage 3 CKD in each region. The study will also assess the current state of CKD management in patients with undiagnosed CKD