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.
To improve medication reconciliation in oncologic patients in healthcare transitions through an alliance between a Cancer Institute and the community pharmacies and a new integrated IT platform.
Palliative care (PC) is focused on improving the Quality of Life (QoL) of patients living with a life-threatening illness. Each year, an estimated 40 million people need PC management in the world. In the European Union, it is estimated that about 4,5 million of people are in the need of PC every year, with about 40% affected by malignant neoplasia. Data from a recent systematic review of the literature report that the prevalence of pain is 66% (95% confidence interval 58-75) in cancer patients with advanced stages of the disease. In 52% of cases, pain was moderate or severe in intensity (NRS, Numeric Rating Scale ≥4). Furthermore, in addition to the basic pain, having characteristics of continuity over time even in the presence of fluctuations in intensity, the presence of acute painful episodes must also be considered, which are defined with the term of Breakthrough Cancer Pain, (BTcP), whose prevalence is estimated between 21 and 59%. The positive impact on the quality of life of cancer patients of adhering to current guidelines has been amply demonstrated. Recently, new guidelines or recommendations produced by scientific societies have published, including the European Association of Palliative Care, the National Comprehensive Cancer Network and the European Society for Medical Oncology (ESMO). In clinical facilities directly involved in the treatment of pain in cancer patients, implementing the directives set out in the guidelines appears to be a correct objective for the appropriateness of treatments. Nevertheless, there are no studies in Europe that have evaluated the applicability and adherence to guidelines in the treatment of cancer pain in advanced cancer patients. The present study intends to collect detailed information on the characteristics of pain and the treatment in a population of cancer patients cared by a network of specialized palliative care centers in order to assess the applicability and adherence of the latest European guidelines published by ESMO in 2018 for the treatment of pain in the specific area.
The newly recognised disease COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which by early December 2019 had spread from China to the rest of the world, especially Europe, the United States, Latin America, and India, with over 86 million confirmed cases and over 1.870.000 deaths (5th January, 2021). The clinical spectrum of SARSCoV- 2 infection is wide, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and even death. According to retrospective data from China regarding 1099 patients with laboratory-confirmed COVID-19, at the time of admission to hospital, the most common symptoms were cough (67.8%), fever (43%), and fatigue (38.1%), and less frequently myalgia/arthralgia (14.9%), a sore throat (13.9%) and headache (13.6), while nausea or vomiting (5.0%) and diarrhoea (3.8%) were uncommon. Similar clinical characteristics are also encountered in European and US COVID-19 patients. Given the rising global death toll associated with the pandemic, in the past few months we have witnessed a race to find drug/biological treatments to save the lives of hospitalized, severely ill patients, as well as to develop vaccines. To this end, randomized clinical trials are underway to test experimental drug candidates, or repurposed medicines. At this time, it is crucial to focus on primary care physicians and initial mild symptoms at home in COVID-19 patients. Recently recommendations have been produced to treat this illness at home based on the pathophysiologic and the pharmacologic rationale and the available clinical evidence of efficacy in COVID-19 patients, including results of published clinical trials, for each of the recommended class of drugs. These recommendations have taken advantage from the long term experience of an infection disease specialist and other clinicians of Bergamo Hospital, who used their know-how and sound judgment to treat COVID-19 patients at home. 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. Moreover, COVID-19 is a particularly debilitating illness, and, apart from causing patients to be bedridden, there is evidence that in SARS-CoV-2 infection, dysregulation of the coagulation cascade and fibrinolytic system occur. Therefore, COVID-19 patients are exposed to the risk of thromboembolic events, independently of age, and anticoagulant prophylaxis is recommended, unless contraindicated. 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 novel therapies. Thus, we will use this approach in an observational retrospective matched-cohort study to compare a cohort of COVID-19 patients treated at home by their family phisicians according to the proposed recommendations with another cohort of similar patients treated with other therapeutic regimens. Our working hypothesis is that following the recommendations the inflammatory processes and thus symptoms resolve faster than with other therapeutic approaches, while safe achieving similar rates of complete remission of the illness.
- Phase 2 Study Objectives: efficacy and safety of of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia - Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the control arm in adult patients with moderate or severe COVID-19 pneumonia
This is a phase 2b, prospective, randomized, cross-over, double-blind, placebo-controlled trial primarily aimed at assessing whether the SGLT2 inhibitor dapagliflozin ameliorates hyperfiltration and reduces proteinuria as compared to placebo in patients with non-diabetic CKD, with particular focus on those at highest risk of progression to end stage kidney disease (ESKD) because of severe renal insufficiency (Stage IV CKD) and proteinuria (>0.5 g/24 hours). The study will also evaluate renal and systemic mechanisms mediating treatment effects on GFR and will explore biochemical factors possibly mediating these effects.
This is a phase 2 study conducted in two sequential stages: The first stage is an Italian single institution, single arm, pilot study, aimed at exploring the activity of the combination T and P in myxoid liposarcoma patients who achieved a stable disease after a minimum of 4 cycles of T alone. If a minimum required activity will be demonstrated from the first stage, the second stage of the study will be conducted;otherwise, the study will be stopped. The second stage is an Italian open-label, multicenter, randomized, double arm, phase II trial, aimed at evaluating the combination of T and P in myxoid liposarcoma and G1 or G2 dedifferentiated liposarcomas compared to the standard treatment with T alone. Patients will be randomized with a 1:1 ratio to treatments arms as specified below: - Control arm (A): T alone - Experimental arm (B): T in combination with P
hemiplegia is a pathological condition that affects one side of the body which is associated with difficulty in maintaining an upright posture and walking and which is commonly compensated for by using orthoses (AFO). However, the orthoses are inadequate for sports from a design and prescription point of view, which specifies that the goal of the orthosis is to support walking and that any other use compromises its reliability. The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses.
A clinical trial of AAV5-hRKp.RPGR vector for participants with X-linked retinitis pigmentosa (XLRP)
Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.
The main aim of this study is to compare the efficacy of short-course versus long-course pre-operative chemotherapy with PAXG or mFOLFIRINOX in patients who receive a diagnosis of pancreatic ductal adenocarcinoma (PDAC) resectable or borderline resectable.