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 study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound dehiscence and inframammary fold break. Such complications are promoted by elastic properties of tissues and their response to gravity forces exerted on breast implant weight, leading to microischaemic events. A poor cosmetic outcome may result up to breast implant exposure, and its removal may become necessary, thus compromising the quality of breast reconstruction. These complications are further favoured by post-mastectomy radiotherapy (PMRT), since irradiation could enhance microischaemia of peri-prosthetic soft tissues and muscle, with subsequent inadequate healing, fibrosis and thinning. Since PMRT has been associated to improved loco-regional control in node-positive breast cancer patients, its use has increased in recent years. On one hand, PMRT has improved loco-regional control but, on the other hand, it has increased the failure rate of breast reconstruction after total mastectomy. Change of timing in breast reconstruction (immediate vs. two-staged by use of tissue expander) has not decreased the complications rate after PMRT. Currently the failure rate of breast reconstruction after total mastectomy and PMRT ranges from 0% to 40%. The present study will recruit 80 participants affected by breast cancer candidated to total mastectomy with immediate breast reconstruction and subsequent PMRT or total mastectomy with reconstruction by tissue expander, subsequent PMRT and then definitive reconstruction with breast implant. Participants will be randomized in two experimental arms: 40 patients will receive final reconstruction by the use of standard silicone-based breast implant and the other 40 patients will receive B-Lite® light weight breast implant. Participants will be followed up at 1, 6, 12 and 24 months, and all patients will undergo breast MRI at 6 months. The primary goal of the present study is to evaluate the failure rate of breast reconstruction (i.e. the need of re-intervention for breast implant removal). Secondary end-points include the overall complications rate, MRI evaluation of breast implant and surrounding tissues, cosmetic outcomes and quality of life including participants' satisfaction with breast reconstruction.
The primary objective of this study was to assess the efficacy of rilonacept treatment in participants with recurrent pericarditis.
Luteal phase support in "in vitro fertilization" (IVF) cycles has been shown to improve pregnancy rates and became a standard of treatment, and progesterone is the first choice considering its safety profile and effectiveness. There are many studies demonstrating that vaginal progesterone is equally efficacious and better tolerated compared to intramuscular progesterone for luteal phase support in IVF cycles. Conversely, although different studies showed that subcutaneous progesterone is equally efficacious compared to vaginal progesterone, patient use satisfaction and compliance were less studied with few evidences are available, that may guide the choice of vaginal progesterone instead of subcutaneous progesterone and other way around. Considering the paucity of published data about the patient's preference and use satisfaction about subcutaneous progesterone, the investigators will conduct a prospective randomized study aimed to compared adverse effects rates, impact on quality of life, use satisfaction and administration preference in women undergoing luteal phase support with vaginal progesterone versus subcutaneous progesterone during IVF cycles, that may guide the choice for luteal phase support in IVF cycles.
The aim of this study is to assess the utility of two interventional videos, showed to patients discharged from the ED with a diagnosis of atrial fibrillation or deep vein thrombosis. We have focused our attention on these two medical conditions because they share some important features: they are frequently seen in EDs; their main complication (stroke and pulmonary embolism) can cause significant morbidity and mortality; both conditions and their related complications are probably not very intuitive to comprehend for the general population. In fact, the understanding of these conditions implies the knowledge of a number of pathological processes, with which most people are unfamiliar. The primary hypothesis is that patients enrolled in the study group will show a higher degree of comprehension of their medical condition and its related complications, as compared to the control group. Secondly, we will also analyze any possible effect of the videos on the knowledge of the therapy prescribed, return instructions and patients' satisfaction with the quality of communication in the ED. Eventually, we will examine the association of some factors with the outcomes (age, sex, level of education, atrial fibrillation vs. deep vein thrombosis group).
In this study phenylbutyrate is used for patients with pyruvate dehydrogenase complex deficiency. The aim of the study is to investigate the safety and efficacy of therapy.
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of electroanatomical mapping with the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (hereafter called "HD Grid") and EnSite Precision™ Cardiac Mapping System (SV 2.2 or higher, hereafter called "EnSite Precision") with HD Wave Solution™ voltage mapping (hereafter called "HD Wave Solution") in subjects with persistent atrial fibrillation (PersAF) or ventricular tachycardia (VT) in real-world clinical settings.
The purpose of this study is to evaluate the efficacy and safety of baricitinib in combination with topical corticosteroids (TCS) in participants with moderate to severe atopic dermatitis.
This is a prospective two-stage single arm phase II study to be conducted in conformance with Good Clinical Practices. This study will enrol 53 patients, based on a two steps Simon's design. Patients will entry into the study if the following conditions will be satisfied: - BRCA1/2 germline mutations. - Metastatic disease with measurable lesions will be evaluated by computed tomography or by PET (Positron Emission Tomography) scan. - Patients must have received anthracycline and taxanes before entry into the study. Patients will be treated with Carboplatin AUC6 (Area Under The Curve) EV (endovenous) every 3 weeks in combination with Pembrolizumab 200 mg EV every 3 weeks for 6 cycles. Afterwards, the Pembrolizumab will recontinued with the same schedule until unacceptable toxicity or disease progression. The primary endpoint will be Objective Responses Rate (ORR) (complete answers + partial answers) evaluated according to the RECIST criteria.