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.
This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions. MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (<1mW) microwave. The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position. MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.
The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): 1. arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. 2. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months.
This is a phase IV, interventional, multi-center, open clinical Trial. Patients will be administered one eye drop of tafluprost/timolol fixed combination at 20:00 (+/- 1 hour), in the treatment of open angle glaucoma and ocular hypertension. The patients will suspend the treatment with latanoprost.
There is evidence from cohort studies and metanalysis that a shift from BRAFWT to BRAF mutated melanomas can occur (Colombino JCO 2012, Valchis EJC 2017). Based on previous studies we expect that 15% of tissue BRAF WT patients treated with anti PD-1 will become circulating free DNA BRAF (CfDNA BRAF) mutation-positive and, at progression, they will be elegible to be treated with dabrafenib/trametinib. We aimed to design a clinical phase II trial in order to evaluate the activity of Dabrafenib and Trametinib in patients with Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy.
Failure of conventional radioiodine therapy of metastatic differentiated thyroid cancer could be explained by: - a suboptimal therapeutic approach, based on the administration of empirically fixed amount of radioactivity - the presence of lesions with impaired iodine uptake, due to the expression of specific mutations The study aims to: - optimize therapy with pre-treatment 124-I blood and lesion dosimetry - collect genetic data to check if specific mutations and/or miRNA over-expression could be related to low iodine uptake or to radioresistance
The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed/refractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.
Since protein and AAs are master regulator of GH and IGF-I secretion, we hypothesized that a low protein diet could reduce GH and IGF-I levels in acromegalic patients in addition to conventional therapy. Furthermore, we aim to explore metabolomic, microbiota, and micro-vesicle fingerprints of GH hypersecretion during conventional therapy and after a low protein diet
This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.
Class II malocclusion presents a major and common challenge to orthodontists. Treatment of Class II malocclusion is one of the most investigated and controversial issues in contemporary orthodontics because of the extensive variability of treatment strategies addressing the morphological characteristics of this malocclusion. The therapeutic approaches include tooth extractions, orthopedic appliances and extraoral or intraoral distalizing appliances. Maxillary molar distalization is one of the most common strategies to correct Class II molar relationship and it is commonly indicated for patients with maxillary dentoalveolar protrusion or minor skeletal discrepancies. One of the most used devices is Pendulum appliance, introducted by Hilgers in 1992. In the last decades, the orthodontic treatment with removable clear aligners has become an increasing common choice because of the growing number of adult patients who ask for aesthetic and comfortable alternatives to conventional fixed appliances. In 1997, Align Technology (Santa Clara, Calif) adapted and incorporated modern technologies to introduce the clear aligner treatment (CAT). Only few investigations have focused on the predictability of orthodontic tooth movement with CAT. A systematic review by Rossini et al. pointed out that among the dental movements analyzed in 11 studies, the bodily distalization was the most predictable. Clinicians can consider the use of aligners in treatment planning for adult patients requiring 2 to 3 mm of maxillary molar distalization. However, a detailed analysis of the skeletal and dental changes that compared pendulum appliance and clear aligners in class II treatment is still lacking. On the basis of these considerations, the aim of the present prospective study was to analyze the effects on vertical dentoskeletal changes following maxillary molar distalization with pendulum and full fixed appliances and clear aligners.
The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.