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.
Type 1 Diabetes (T1D) is a chronic autoimmune disease, with a genetic background, resulting from the immune-mediated destruction of beta cells of the pancreas. It can lead to fatal short-term and long-term complications, especially if it is diagnosed late. Three stages of the disease can be identified: Stage 1 is defined by the presence of two or more anti-islet autoantibodies (GAD65, ICA, IA-2, ZnT8) with normoglycemia, Stage 2 shows progression to dysglycemia (impaired glucose tolerance) in the setting of two or more anti-islet autoantibodies, Stage 3 occurs when a patient meets ADA criteria for the diagnosis of diabetes. It's been demonstrated that Teplizumab (an Fc receptor nonbinding anti-CD3 monoclonal antibody) delays the transition from pre-symptomatic T1D (stage 2) to overt T1D (stage 3). Also Sitagliptin, a DPP4 inhibitor, has been proved effective in inhibiting inflammation in T1D both in vitro in T1D mice, and in vivo in Latent autoimmune diabetes in adults (LADA) patients. Furthermore, it has been confirmed that Sitagliptin reduces the prevalence of worse forms of acute GVHD after myeloablative allogeneic hematopoietic stem-cell transplantation. The study aims to investigate if Sitagliptin can have a delaying effect on progression to overt T1D, on the account of its anti-inflammatory properties. The cohort is made of screened relatives of T1D patients, who are classified as high-risk of developing T1D. Screening relatives of T1D patients for dysglycemia and anti-islet autoantibodies. Selecting the patients in Stage 2 Pre-symptomatic T1D (dysglycemia and at least two types of autoantibodies) and then beginning therapy with Sitagliptin, while monitoring their glucose metabolism with a Continuous Glucose Monitoring (CGM) system.
The incidence of pulmonary complications such as pulmonary atelectasis, pneumonia (including ventilator-associated pneumonia), and acute respiratory failure is high in critical care patients. The incidence of ventilator-associated pneumonia can be as high as 27% amongst mechanically ventilated patients. Studies have shown that 16% of critically ill patients have been reported to develop acute respiratory failure, which is associated with prolonged intensive care unit stay, resulting in significantly higher mortality than non-respiratory failure patients. Increased morbidity and mortality contribute to the burden on the health care system and lead to poor health-related outcomes. Multimodal physiotherapy plays a role in the management of these critically ill patients. High frequency percussive ventilation (HFPV) is used in patients with underlying pulmonary atelectasis, excessive airway secretions, and respiratory failure. HFPV is a non-continuous form of high-frequency ventilation delivered by a pneumatic device that provides small bursts of sub-physiological tidal breaths at a frequency of 60-600 cycles/minute superimposed on a patient's breathing cycle. The high-frequency breaths create shear forces causing dislodgement of the airway secretions. Furthermore, the HFPV breath cycle has an asymmetrical flow pattern characterized by larger expiratory flow rates, which may propel the airway secretions towards the central airway. In addition, the applied positive pressure recruits the lung units, resulting in a more homogeneous distribution of ventilation and improved gas exchange. In acute care and critical care settings, HFPV intervention is used in a range of patients, from spontaneously breathing patients to those receiving invasive mechanical ventilation where HFPV breaths can be superimposed on a patient's breathing cycle or superimposed on breaths delivered by a mechanical ventilator. The most common indications for HFPV use are reported as removal of excessive bronchial secretions, improving gas exchange, and recruitment of atelectatic lung segments. This study aims to assess the lung physiological response to HFPV in terms of aeration and ventilation distribution.
In patients suffering from acute respiratory failure, ineffective cough and the consequent retention of secretions are common clinical problems, which often lead to the need for tracheostomy for the sole purpose of aspiration of secretions from the airways. Mechanically ventilated critically ill patients often have impaired mucus transport which is associated with secretion retention and subsequent development of pneumonia. The accumulation of tracheobronchial secretions in ventilated patients in ICU is due not only to an increased production, but also to a decreased clearance. In the event that secretions occlude a bronchus, an atelectasis of the lung parenchyma is created downstream. Therefore, it is often necessary to perform a flexible bronchoscopy (FOB) to proceed with the removal of the secretion plug. After its removal, the lung is supposed to be reventilated and recruited. In intubated ICU patients, the application of a recruiting maneuver (RM) is commonly used to reopen the collapsed lung in patients with Acute Respiratory Distress Syndrome or in case of atelectasis in other clinical conditions. However, no studies have so far investigated the role of the application of a RM after a FOB performed to remove a secretion plug in intubated ICU patients. This observational and physiological study aims to assess if the application of a RM would modify the lung aeration soon after an FOB to remove secretion plug (first outcome). Moreover, the study aims to assess if EIT could be an additional bedside imaging tool to monitor modifications of lung ventilation and aeration during and after a flexible bronchoscopy, as compared with both chest-X-ray and lung ultrasound.
The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications. In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.
Evaluate the effect of the PICO medical device, compared to the Opsite Post-Op Visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk of local complications, undergoing hip arthroplasty
Chitosan is a natural polysaccharide of β-1,4-linked glucosamine residues deriving from chitin, a dietary fiber primarily obtained from fungal cell walls and the exoskeletons of various crustaceans (e.g. crab, lobster, and shrimp) and whose cholesterol-lowering properties are due to the hydrophobic bonds it forms with cholesterol and other sterols, interfering with the emulsification process in the intestine. In addition to reducing low-density lipoprotein cholesterol (LDL-C) levels, several studies showed that chitosan administration may help reduce body weight. For this reason, its use might be particularly useful as a strategy to simultaneously control two different risk factors for the development of CVDs.
Formation of a registry of IMID patients to assess the evolution of resistance to conventional and target therapies. This aim is achieved by evaluating the achievement of PASI 50 and PASI 75 scores at week 16 from the start of treatment.
Myocardial strain analysis has emerged in the last decade as a reliable tool for studying myocardial mechanics, adding information on cardiac performance when compared with traditional parameters of left ventricle (LV) systolic function, such as ejection fraction (EF). However, their relative load dependency makes the myocardial deformation indices unable to account for changes in pre- and afterload. Myocardial work (MW) is emerging as an alternative tool for studying LV myocardial systolic function, because it incorporates both deformation and load into its analysis. The purpose of this observational trial is to validate the use of MW in septic shock patients by means of consecutive echocardiographic assessment at predefined timepoints. Secondarily, we'll evaluate the impact of the vasoactive drugs used in septic shock patients (vasopressors and inotropes) on MW and on ventriculo-arterial coupling.
Genitourinary syndrome of menopause (GSM) occurs in approximately 50% of menopausal women but is both underrecognized and undertreated despite numerous treatment options. Vaginal dryness, irritation, dyspareunia, urinary frequency, and urinary urgency are some of the more common symptoms that can have a negative effect on women's lives and relationships. In particular, dyspareunia is localized in the vestibule with specific trophic changes more evident than those localized in vagina. The CO2 fractionated laser, has also been found to be useful in several studies for the treatment of vaginal atrophy. In this open comparative study, 70 female menopausal subjects aged between 40 and 70 years old at inclusion, having symptoms of GSM (Vaginal dryness, burning/pain, dyspareunia,dysuria), have given her informed consent and meet all the eligibility criteria, will be enrolled. The two groups of comparison will be 35 subjects treated into vagina and vestibule, versus 35 subjects treated into vagina, only. Subjects will come to a total of 6 visits over a period of 3 months. The primary objective of the study is to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser comparing its administration into vagina and vestibule versus into vagina, only. The evaluated outcomes are vaginal dryness, burning/pain, dyspareunia, sensitivity to touch at Swab test, Female Sexual Function Index (FSFI) and Vulval Pain Functional Questionnaire (VQ) at day 84 and 120 and the safety during all the study. The secondary objectives are the evaluation of vaginal and vestibular trophism, measured by Vaginal Health Index (VHI) and Vestibular Health Score (VHS) at the FU visits.
Vestibulodynia (VBD), term revised by Consensus Terminology and Classification of Persistent Vulvar Pain and Vulvodynia in 2015, is a vulvar pain of at least 3 months' duration, without clear identifiable cause and localized at vestibuli. Women affected by this disease report localized hypersensitivity and pain of the vulvar vestibule to the touch (eg, during sexual intercourse or tampon use). This pattern of responses is suggestive of sensory abnormalities in the form of evoked pain (eg, hyperalgesia or allodynia). Research biopsy studies have demonstrated increased innervation of the vulvar vestibule and increased subepithelial heparinase activity and cytokines that have been associated with neuroinflammatory processes. In addition, the discomfort inherent in VBD is always associated with pelvic floor muscle overactivity, with the development of myofascial trigger points, resulting in localized or radiating pain and/or severe tenderness. A rich nerve plexus was identified within the vaginal submucosa, which was only composed of sympathetic and parasympathetic axons, with contributions of smaller sensory fibers. The sensory nerve endings of the vulvar vestibule are dense and shallow, making this region more physiologically sensitive. Several works suggest that a thinner vestibular mucosa is more sensitive to nociception because nerve endings become more superficial, thus altering the transduction of mechanical pressure to facilitate nociception. The CO2 fractionated laser, has been used to safely and effectively treat symptomatic vaginal atrophy. This tool has also been found to be useful in the treatment of vestibulodynia. In this open pilot study, 30 female subjects aged more 18 years old at inclusion, having symptoms of VBD from at least 6 months, have given her informed consent and meet all the eligibility criteria, will be enrolled. The subjects will be treated with CO2 Fractionated Laser into vestibule, for 3 sessions at monthly intervals with a follow up of 4 months. Subjects will come to a total of 6 visits over a period of 3 months. The primary objectives of the study are to evaluate the performance and safety of Pixel CO2-Alma Fractionated Laser in women affected by VBD by the assessment of vestibular mucosa thickness by ultrasound evaluation and vestibular perception thresholds changes at day 84 and 120 and by searching the adverse event during all the study. The secondary objectives are the assessment of VAS for burning/pain, and dyspareunia, evaluation of pain and hypersensitivity to the touch by Swab test, Female Sexual Function Index (FSFI) and by Vulval Pain Functional Questionnaire (VQ) at the visits.