Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients

Trial registration number: CTRN12611000543987

Radiotherapy plus nimotuzumab or placebo in the treatment of high grade glioma patients: results from a randomized, double blind trial

Background The prognosis of patients bearing high grade glioma remains dismal. Epidermal Growth Factor Receptor (EGFR) is well validated as a primary contributor of glioma initiation and progression. Nimotuzumab is a humanized monoclonal antibody that recognizes the EGFR extracellular domain and reaches Central Nervous System tumors, in nonclinical and clinical setting. While it has similar activity when compared to other anti-EGFR antibodies, it does not induce skin toxicity or hypomagnesemia. Methods A randomized, double blind, multicentric clinical trial was conducted in high grade glioma patients (41 anaplastic astrocytoma and 29 glioblastoma multiforme) that received radiotherapy plus nimotuzumab or placebo. Treatment and placebo groups were well-balanced for the most important prognostic variables. Patients received 6 weekly doses of 200 mg nimotuzumab or placebo together with irradiation as induction therapy. Maintenance treatment was given for 1 year with subsequent doses administered every 3 weeks. The objectives of this study were to assess the comparative overall survival, progression free survival, response rate, immunogenicity and safety. Results The median cumulative dose was 3200 mg of nimotuzumab given over a median number of 16 doses. The combination of nimotuzumab and RT was well-tolerated. The most prevalent related adverse reactions included nausea, fever, tremors, anorexia and hepatic test alteration. No anti-idiotypic response was detected, confirming the antibody low immunogenicity. The mean and median survival time for subjects treated with nimotuzumab was 31.06 and 17.76 vs. 21.07 and 12.63 months for the control group. Conclusions In this randomized trial, nimotuzumab showed an excellent safety profile and significant survival benefit in combination with irradiation.

Modeling Innovative Power Take-Off Based on Double-Acting Hydraulic Cylinders Array for Wave Energy Conversion

One of the key systems of a Wave Energy Converter for extraction of wave energy is the Power Take-Off (PTO) device. This device transforms the mechanical energy of a moving body into electrical energy. This paper describes the model of an innovative PTO based on independently activated double-acting hydraulic cylinders array. The model has been developed using a simulation tool, based on a port-based approach to model hydraulics systems. The components and subsystems used in the model have been parameterized as real components and their values experimentally obtained from an existing prototype. In fact, the model takes into account most of the hydraulic losses of each component. The simulations show the flexibility to apply different restraining torques to the input movement depending on the geometrical configuration and the hydraulic cylinders on duty, easily modified by a control law. The combination of these two actions allows suitable flexibility to adapt the device to different sea states whilst optimizing the energy extraction. The model has been validated using a real test bench showing good correlations between simulation and experimental tests.