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 IRON-MPP is a prospective multicenter, observational registry designed to collect clinical and device data from a large cohort of HF patients treated in clinical practice with a CRT-D device with the ability to deliver Multi Point Pacing. The purpose of the Registry is to collect data on how MPP-devices are being used by physicians in order to better understand how to improve the clinical care of patients and effectiveness of MPP therapy.
The purpose of this study is to determine whether the gastric retentive Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.
The study will investigate in newly diagnosed CP-CML patients the efficacy of NIL frontline therapy vs IM followed by switch to NIL in the case of absence of optimal response as defined by the ELN criteria.
BVS STEMI STRATEGY-IT is a spontaneous, prospective, non-randomized, single-arm multicenter registry on consecutive STEMI patients eligible to undergo primary percutaneous coronary intervention (PPCI) with BVS implantation on the basis of the pre-specified inclusion and exclusion criteria. This registry has the objective to assess the immediate (peri-procedural and 30 days), mid (6 months and 1 year) and long-term (3 and 5 years) results following BVS implantation using a pre-specified implantation strategy during PPCI in STEMI subjects.
This study will assess the efficacy of mirabegron, a new beta3-adrenergic receptor in the prevention of heart failure. This is a two armed, prospective, randomized, placebo-controlled, multi-centric european phase IIb trial with placebo and mirabegron distributed in a 1:1 fashion. The patients enrolled will have cardiac structural remodeling with or without symptoms of heart failure (maximum NYHA II). Patients will be monitored for change in left ventricular mass (assessed by cardiac MRI) and/or changes in diastolic function (assessed by echocardiography) after 12 months of treatment.
The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study. An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.
Traditional treatment options for optic nerve sheath meningiomas (ONSM) include observation, surgery and radiotherapy, but to date none of these has become the clear treatment of choice. The role of the radiotherapy remained uncertain because of the concern about radiation related optic neuropathy In the recent past two large series of patients treated with a fractionated stereotactic radiotherapy confirmed these positive experiences in tumour control and greatly reduced the concern about the treatment related toxicity. Under the light of successful meningiomas treatment, radiosurgery, had proposed as a treatment option. Single session, high conformality, frame based radiosurgery systems are seldom if ever proposed as ONSMs treatment due to the known dose tolerance of the optic nerve. The first experience in ONSMs treatment with multisession radiosurgery treatment was quite promising. The aim of the present study is to prospectively evaluate the efficacy and safety of multisession radiosurgery in ONSMs treatment. In order to evaluate multisession radiosurgery 50 patients will be enrolled in the present study. All patients will be treated by using multisession radiosurgery, with 5 fractions of 5 Gy each to a total dose of 25 Gy prescribed to the 75-85% isodose line. Patients were evaluated both for tumor growth control and visual function.
The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime. This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.
The study will investigate, primarily, the safety, feasibility and tolerability and, secondarily, the preliminary efficacy of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy (ORBCEL-M) in study subjects with type 2 diabetes (T2D) and progressive diabetic kidney disease (DKD).