Rogliano, Italy

EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase

Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera

The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. Laboratory tests and histological, cytogenetic, molecular, and radiological investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular. data on systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. The minimum planned duration of individual patient observation is 3 months and the planned duration of the study is 10 years.

Evaluation of Performance and Safety of Eye Drops With Hydroxypropyl-methylcellulose and Inositol in Drye Eye Disease

MERAMIRT®, a class IIa medical device, is indicated for hydration and lubrication of the ocular surface under conditions of eye disorders caused by environmental, visual and mechanical stress, also due to asthenopia and accommodation effort. The main component of MERAMIRT® are Hydroxypropyl-methylcellulose (HPMC 0.3%) and Inositol (0.1%). HPMC has the property of moisturizing and lubricating the eye. Inositol is used with an antioxidant role. Hypromellose is a polymer that has the property to tick and stabilize the tear film on the corneal surface, which create a protective, transparent and viscoelastic layer. Inositol, as other osmolytes, may contribute to counteract the oxidant action on free radicals produced in condition of asthenopia and accommodative effort. Such activity may indirectly support the muscular metabolic processes favoring the contractile response. MERAMIRT® is a hydrating and lubricant tear replacement indicated in ocular isturbances caused by environmental, visual and mechanic stress, also due to asthenopia and accommodative effort. In a small, open-label study, a 0.3% hypromellose eye gel showed statistically significant effects in relieving ocular symptoms and in improving ocular comfort in patients with dry eye syndrome. Another recent study showed that treatment with punctual occlusion using hypromellose 2% was associated with a significant reduction in signs and symptoms in patients with dry eye. Based on the preliminary available background on the use of hypromellose in the management of dry eye syndrome, this investigation has been designed to assess the efficacy and safety of a sterile ophthalmic solution that contains hypromellose and inositol (MERAMIRT®), in a sample of VDT users suffering of moderate or severe DED with asthenopia and accommodative effort.

Axitinib Intensification Plus Nivolumab or Nivolumab Alone After Nivolumab Plus Ipilimumab in mRCC Patients

The present study aims to demonstrate if the addition of axitinib to nivolumab maintenance after nivolumab plus ipilimumab induction can improve the rate of response considering that the incidence of partial response was 32% and 51% in Checkmate214 and Keynote426 trials respectively. This study requires 106 patients to show an improvement from 30% to 50% of the incidence of partial responses with a power of 80%, and alpha-error 0.10 (one-side p). Assuming a drop out of 10%, the final estimated number to enroll should be 118 (59 in arm A and 59 in arm B).

Probiotic After Acute Colonic Diverticulitis

Evaluation of Inflammatory Markers in ph Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy. Multicenter Retro-prospective Observational Study. The INFLA-ME (INFLAmmation in Myeloproliferative Disease) Study.

Why Does Aspirin Fail in Secondary Cerebrovascular Prevention? A Multicenter Prospective Case - Control Study

Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS (ACROBAT)

Open-label, randomized, prospective multicenter phase III study to compare the role of HMT followed by HSCT vs HSCT upfront in HR-MDS with <10% of BM blasts and of CHT vs HMT followed by HSCT in HR-MDS with >10% BM blasts in terms of feasibility of HSCT (non-inferiority trial).