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 primary objectives of the study are to evaluate the efficacy of BIIB059 (litifilimab) compared with placebo in reducing skin disease activity measured by the Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) score [Parts A and B (US)] and the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) score [Part B (ROW)] in participants with active SCLE and/or CCLE with or without systemic manifestations and refractory and/or intolerant to antimalarials. The secondary objectives of the study are to evaluate the efficacy of BIIB059 in reducing SCLE and/or CCLE disease activity by CLA-IGA-R, CLASI-A; to evaluate additional efficacy parameters of BIIB059 in reducing SCLE and/or CCLE disease activity; safety; tolerability; and immunogenicity of BIIB059 [Parts A and B].
The aim of the present study is to assess if there are differences on perceived pain during local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric patients. Patients responding to the inclusion criteria will be asked to participate to the study. After signing the informed consent, they will undergo local anesthesia procedure on first or second primary molars for the subsequent performing of dental filling. The split-mouth design will randomly allocate first or second primary molar from one quadrant to SleeperOne procedure, while the contralateral one will be subdued to local anesthesia with traditional syringe. After the procedure, patients will be asked to assess the perceived pain with a Visual Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of "size" (related to the two instruments), bitter and vomit.
Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is a sino-nasal chronic inflammatory disease that strongly affects patients' quality of life, especially in difficult-to-treat cases. In severe uncontrolled CRSwNP, the inflammation is mostly driven by a type 2 inflammatory pathway and its management has been rapidly changing during the last 2 years due to Dupilumab approval. It is a fully human monoclonal antibody that binds the alpha subunit of IL-4 receptors (IL-4Rα type 1 and type 2) to inhibit IL-4 and IL-13 signaling. So far, randomized clinical trials have assessed efficacy and safety of Dupilumab in a large number of patients, whereas evidences in real life clinical practice are limited to few monocentric series. Herewith, the investigators present a multicenter, observational nationwide retrospective real-life study with the aim to confirm the effectiveness and the safety of Dupilumab over the first year of treatment in a real life setting. The primary objective is to evaluate the volumetric reduction of polyps by measuring the variation of total Nasal Polyp Endoscopic Score (NPS). The secondary objectives are: - the evaluation of changes in nasal symptoms, olfactory function and nasal obstruction - the assessment of the patients' quality of life - the recording of major and minor complications - the evaluation of the response to the therapy, according to EPOS2020 criteria and EUFOREA2021 - the assessment of efficacy based on concomitant disease (Asthma and ASA triad) - the evaluation of potential predictors of clinical response to the therapy
This study is an open-label, 2-part, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab in participants with advanced cutaneous melanoma refractory to checkpoint inhibitor therapy.
In recent decades, the world prevalence of obesity and type 2 diabetes (DMT2) has increased dramatically, resulting in a global epidemic. One of the aspects more connected to the etiology of these pathologies is undoubtedly the concept of the glycemic index (GI) and glycemic load (CG). It has been shown that, with the same CG, that is of carbohydrates contained in a food, a food with a higher GI tends to raise blood sugar more quickly (and consequently insulin), causing several negative effects on the body. We now have sufficient evidence to show that high GI diets are associated with increased incidence of DMT2, hyperlipoproteinemia, and cardiovascular disease. Although simple carbohydrates, namely sugars, have always been considered the major inducers of hyperglycemia and hyperinsulinemia, in reality also starches, or complex carbohydrates digestible by humans, may lead to an increase in blood sugar levels which is not as rapid but often equally harmful to health, since the GC is generally higher. The reason why a high GI diet is responsible for this increased risk of developing pathologies is not unambiguous. We can identify at least 4 probable mechanisms. 1. Sudden hyperglycemia tends to cause insulin to rise beyond what is necessary, leading subsequently to the risk of hypoglycemia and thus an excessive feeling of hunger. Increased energy intake and obesity. 2. Excess insulin secretion, aggravated by insulin resistance, represents an effort for the pancreas with the risk, over time, to arrive at a deficit of insulin-dependent diabetes type 2 insulin production 3. Hyperinsulinemia is also associated with reduced lipolysis and increased lipogenesis obesity and hyperlipoproteinemia 4. Fat accumulation, especially in the abdominal region, is associated with chronic inflammation and insulin resistance by type 2 diabetes tissues and metabolic syndrome In addition to these reasons, a high GI diet, typically called Western Diet, is also generally deficient in plant foods, rich in antioxidants and photo compounds with anti-inflammatory action, without which the process of chronic organic inflammation is accelerated, even in the absence of real obesity.
High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and respiratory effort. The aim of this randomized crossover physiological study is to investigate the effects on PaCO2 levels of two different nasal cannula ('Optiflow + Duet' interface vs "standard" nasal interface) in COPD patients with persistent hypercapnia following an acute severe exacerbation
The Micra MC1VR01 or Micra AVMC1AVR1 Transcatheter Pacing System (Medtronic, Inc., Minneapolis, MN, USA) has become a major breakthrough as an alternative to standard transvenous pacemakers. The aim of this multi-center study is to assess the clinical outcomes of patients implanted with Micra LLPM in real life, in different clinical scenarios.
Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis.
Endometriosis is defined as the presence of endometrial glands and stroma outside the uterine cavity. It is an estrogen-dependent chronic inflammatory disease. Estimates show that up to 10% of premenopausal women have endometriosis. The most frequent forms of endometriosis are superficial peritoneal implants, ovarian cysts and deep nodules or plaques. However, the pelvis is not the exclusive site of endometriotic lesions: endometriosis can also affect the diaphragm, the pleura and the lung. All these localizations are included in the spectrum of "thoracic endometriosis". Thoracic endometriosis may present with cough, wheezing, catamenial pneumothorax, hemothorax, hemoptysis and pulmonary nodules. If the diaphragmatic pleura is also involved, catamenial periscapular or neck pain may be associated with irritation of the phrenic nerve. The symptoms of thoracic endometriosis generally have catamenial onset. Thoracic endometriosis rarely occurs isolated. It is considered a progression of pelvic endometriotic disease. Due to its varied presentation, diagnosis can be particularly difficult and often only identified due to clinical suspicion. The instrumental diagnosis of pneumothorax and catamenial hemothorax can be obtained by radiography or computerized axial tomography of the chest. Magnetic resonance imaging is to be preferred in case of diaphragmatic involvement. The gold standard remains exploratory laparoscopy, possibly accompanied by Video Assisted Thoracic Surgery (VATS). The first-line treatment is hormone therapy, aimed at suppressing ovulation and also preventing the onset of relapses. GnRH analogues are very effective in reducing the painful symptoms associated with endometriosis, but are not superior to other first-line treatments available. Furthermore, the prolonged hypoestrogenism can cause menopausal symptoms and osteoporosis. Surgery should be considered a second-line treatment in case of intolerance or ineffectiveness of medical therapy. The surgical approach is multidisciplinary and involves the endoscopist gynecologist and the thoracic surgeon expert in VATS. The principal aim of the study is the retrospective evaluation of thoracic endometriosis cases in our clinic over the last 20 years in order to evaluate the effectiveness of medical and surgical treatments in terms of satisfaction of patients suffering from this clinical condition. The secondary aim is to investigate the pathogenetic aspects of this clinical condition.
To assess the efficacy and safety of osimertinib in participants with EGFRm positive stage II-IIIB NSCLC, following complete tumour resection with or without adjuvant chemotherapy.