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 CVP-COVID19 registry is both a retrospective and prospective study design in order to identify predictors of cardiovascular disease progression and mortality for COVID-19. The registry enrolls consecutive patients with positive microbiological tests for SARS-CoV-2 admitted to an academic hospital in northern Italy for worsening of COVID-19 symptoms. The study does not test any new diagnostic or therapeutic approach. Patients are treated according to good clinical practice. Patients characteristics, including medical history (with particular attention to cardiovascular and pneumological risk factors), features of physical examination, results laboratory and radiological tests and treatments (pre- and in-hospital) are related with patient outcome. Logistic analysis (univariate, multivariate and propensity) are performed in order to identify factors associated with disease progression. Primary endpoint: mortality.
In December 2019 the first case of human infection by a new coronavirus was identified, currently called SARS-COV-2 (Severe Acute Respiratory Syndrome - Coronavirus - 2), characterized by high contagiousness and the possibility of causing a severe acute respiratory distress syndrome from which its acronym derives and which caused the state of a global pandemic in a few months. The most frequent clinical manifestation of COVID-19 is pneumonia, which in about 20% of cases results in acute respiratory failure. Very few studies have so far addressed the problem of clinical and functional recovery in these patients, most of them just before or after discharge and none specifically focused on patients admitted for ARF. Indeed most of these investigations were limited to a specific field such as symptoms, pulmonary function and radiological changes. There are no guidelines for the follow-up of COVID-19 patients, despite the British Thoracic Society (BTS) has published a guidance for scheduling post-hospitalization assessments. Aim of this study is to describe the long term (6 to 12 months) evolution of lung involvement in patients discharged after an episode of ARF due to COVID-19, identifying possible factor associated to lasting clinical, functional or radiological abnormalities collecting data from hospital stay, 1-month after hospital discharge, 3-months after hospital discharge and 6-to-12-months after hospital discharge.
Incidence of paediatric urolithiasis is increasing in Europe and North America. Nowadays the management of stone disease is a common practice in not endemic country. The surgical's treatment is based on similar techniques as for adults. In the last years due to miniaturization of endoscopic instruments endourology has become the best approach to treat urinary stones in children. The investigators have retrospectively reviewed experience from 01/01/2000 to 28/02/2019 in children ≤ 16 years old affected by urinary stones who underwent rigid and flexible ureterorenoscopy and pecutaneous nephrolitotripsy procedures and recorded clinical data, overall success rate and complication.
The purpose of this study is to evaluate the ability of a single dose of the investigational RSV Maternal vaccine, administered intramuscularly (IM) to pregnant women aged 18-49 years, in good general maternal health, in preventing medically assessed RSV associated Lower Respiratory Tract Illnesses (LRTIs) in infants born to vaccinated mothers. The study will also evaluate the safety of the investigational RSV Maternal vaccine both in vaccinated mothers and in their corresponding infant. Following a recommendation from the Independent Data Monitoring Committee of NCT04605159 (RSV MAT 009), GSK made the decision to stop enrolment and vaccination in the study. Ongoing study participants will continue to be monitored as part of the study.
Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.
Chronic Migraine and Migraine without aura at high frequency are disabling conditions also in adolescence age (2% of adolescents report chronic migraine) Common pharmacological treatments are often inadequate. It has been reported that clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patients to become more conscious about their symptoms and able to manage pain without medication. Generally, according to standard clinical practice, young patients (12-17 yrs old) treated by mindfulness practice come to the hospital to practice mindfulness in small groups of patients for 6 weekly 45 minutes sessions. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients missed the possibility to come for the regular practice to the hospital: for this reason the investigators propose a small pilot study to enforce the use of technology for patients so that they can continue to be followed during their therapeutic process. This preliminary study will be conducted on 25 patients They will be trained to practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital. Also a weekly video-session will be performed to evaluate the clinical condition, to practice guided mindfulness sessions and to encourage to use strategies for pain management . This modality will allow patients to continue their therapeutic process and to be followed regularly during the one year after treatment. Follow up sessions are planned every three months: these meetings at the hospital will be face-to-face with every patient to check the clinical condition by the patient's diary. Last follow up one year after treatment.
Cytoreductive surgery is currently the main treatment for advanced epithelial ovarian cancer (AEOC), and the complete disease removal (RT=0) or the achievement of an optimal residual disease (RT < 1 cm) remain the factors with the greatest prognostic impact, both in primary debulking surgery (PDS) and interval debulking surgery (IDS). To achieve the no residual disease (RT=0), several surgical manoeuvres are often needed both at the upper and lower abdomen, including intestinal resections. Recto-sigmoid resection is certainly the most frequent of intestinal resections, and it is also the one with the highest risk of complication. Albeit rare, anastomosis leakage (AL) is a life-threating condition and therefore it is the most feared of intestinal complications. The aim of this large single-center retrospective study was to assess the AL rate in patients subjected to colorectal resection and anastomosis during primary surgery (PDS or IDS) for advanced ovarian cancer, in a third referral centre for gynecologic oncology with ESGO certification. In addition, we evaluated several possible pre/intra and post-operative risk factors for AL in order to identify, at an early stage, the population at greatest risk, and attempt to reduce the morbidity and mortality of this severe post-operative complication
This is a multi-centre, open-label, single-dose safety, tolerability and PK-pharmacodynamics (PD) study of the vasodilator regadenoson in 3 paediatric age groups for whom a pharmacologic stress perfusion CMR test is clinically indicated; adolescents aged 12 to <18 years (Cohort A), children aged 2 to <12 years (Cohort B), and infants aged 1 to <24 months and who weigh at least 3 kg (Cohort C). Regadenoson will be used as the pharmacologic stress agent in this study with MPI serving as both surrogate pharmacodynamic marker of the agent (MPR, MBF) and a clinically evaluable examination for the patient
Background: Due to the complexity of the interventions in recovering the upper limb, at the moment there is a lack of evidence about the efficacy of rehabilitative interventions. Action Observation Training (AOT) constitutes a promising rehabilitative method to improve upper limb motor recovery in stroke patients. Objective: The aim of the present study was to evaluate the effect of AOT both on upper limb recovery and on functional outcome when compared to patients treated with the task oriented training (TOT). Both treatments were added to traditional rehabilitative treatment.
The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e. with human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring fibroblast growth factor receptor 2 (FGFR2) genetic aberrations (GA).