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.
Coronavirus disease-2019 (COVID-19), a viral respiratory illness caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), has been associated with the occurrence of cardiovascular adverse events including acute myocardial injury, acute heart failure, cardiac arrhythmias, and thromboembolic disease. These complications represent an important issue in COVID-19 patients accounting for the increased morbidity and mortality of this syndrome. According to a scoping review, venous thromboembolism and stroke occurred in approximately 20% and 3% of patients, respectively, with higher frequency observed in severely ill patients admitted to intensive care units. Despite the use of pharmacological thromboprophylaxis, the thrombotic risk still remained elevated in severe COVID-19 patients, and the optimal doses and timing of anticoagulation are not yet defined. The pathogenesis of COVID-19 associated thrombosis recognizes a prominent role of endothelial damage induced by both direct viral injury and an excessive and aberrant hyper-inflammatory host immune response associated to an increase in infection-related cytokines and chemokines. The occurrence of a hypercoagulable state in COVID-19 patients associated to a profound endothelial cell activation/dysfunction can result in the pathological phenomenon of immunothrombosis. In this study, in a prospective cohort of consecutive COVID-19 hospitalized patients, an extensive characterization of the hemostatic alterations were performed, in order to: 1) clarify mechanisms underlying the coagulopathy in these patients; 2) how and to what extent the concomitant infection with SARS-CoV-2 affect this coagulopathy; and 3) identify biomarkers potentially predictive of disease outcome (i.e. any thrombotic recurrence and death).
The objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with CLI undergoing tibial artery revascularization. Patients will be randomized 1:1 to Paclitaxel eluting balloon (Litos, ACOTEC ltd) or sirolimus eluting balloon (Magic touch, Concept Medical) after optimal balloon angioplasty. The primary endpoint of the study is the late luminal loss at 6 months angiography. Secondary endpoint are major amputation, clinically driven target lesion revascularization and vessel reocclusion (duplex) at 12 months.
INTELLiVENT-Adaptive Support Ventilation (ASV) is a fully automated closed-loop mode of mechanical ventilation available on commercial ventilators. Evidence for clinical benefit of INTELLiVENT-ASV in comparison to non-automated ventilation is lacking. The ACTiVE study is an international, multicenter, randomized controlled trial in invasively ventilated ICU patients with the objective to compare INTELLiVENT-ASV to conventional ventilation. We hypothesise that INTELLiVENT-ASV shortens the duration of ventilation. The secondary hypothesis is that INTELLiVENT-ASV improves the quality of breathing.
Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.
This is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of HMA plus venetoclax in AML patients unfit for intensive chemotherapy in a "real-life" scenario. No additional procedures or visits other than those required by normal clinical practice will be required. Patients will be observed for at least 24 months.
This is a prospective Phase II multi-center study with an upfront 16-week, randomized, double-blind, placebo-controlled period, and extension periods, to assess the efficacy, safety and pharmacokinetics of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth spectrum (PROS).
This is a national multicenter study that involves 54 Internal Medicine Units throughout Italy. It is designed as a replicate of two cross-sectional surveys interspersed with an educational program. The study is composed by three steps. Phase 1 concerns a retrospective data collection pertaining to patients with known diagnosis of T2DM. In phase 2 an educational training (focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1) will be conducted in 36 randomized centres out of the 54 ones enrolled (cluster randomization). The ratio 2:1 has been selected in order to offer to the majority of Centres the opportunity to undergo a program of training and maximize the potential positive effect of the educational program on patient management. Randomization will be performed at the beginning of the study. Centres will be selected according to their ability to prescribe all classes of antidiabetic drugs. Phase 3 will occur around 6 months after the training and concerns a new data collection mirroring the previous one. In the phase 1, as well as in the phase 3, the data collection will be based on the review of the medical records of the last 40 consecutive patients with T2DM hospitalized in each Centre of Internal Medicine (in total, 80 patients for each Centre). After a period of 6 months from the hospitalization, a phone call follow up will be performed to know the clinical status of the patient enrolled, if he/she has been re-hospitalized after the index admission and current diabetes treatment.
This is a biological study for adult MDS patients who undergo HSCT procedure. Viable bone marrow samples will be collected and cryopreserved from MDS patients before transplantation and at clinical disease recurrence. CD34+ blast cells at disease relapse after HSCT will be compared with CD34+ cells collected before transplant to study genomic and transcriptomic changes.
The optimal treatment strategy in patients with early progressive disease is not well known. In recent years, novel insights into the biology of Follicular Lymphoma (FL), and especially the role of the microenvironment, have resulted in the development of multiple novel treatment modalities. These new agents may ultimately improve the outlook for patients with FL with an unfavorable course, but for the development of the optimal therapeutic strategy, knowledge on the clinical and biological determinants of early refractory FL is needed.