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 purpose of this study is to evaluate the efficacy and safety of pirfenidone in participants with fibrosing interstitial lung disease (ILD) who cannot be classified with moderate or high confidence into any other category of fibrosing ILD by multidisciplinary team (MDT) review ("unclassifiable" ILD).
The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.
The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.
Physical activity delays all-cause mortality in the general population and reduces the risk of cardiovascular disease (CVD), stroke, type-2 diabetes and some types of cancer (Garber et al., 2011). These diseases are associated with chronic inflammation, which is characterized by activation of inflammatory signalling pathways with abnormal production of cytokines and other mediators (Hotamisligil, 2006). Observational studies of large population cohorts have consistently shown an association between physical inactivity and low-grade systemic inflammation and interventional studies a reduction of inflammatory markers following exercise (Beavers et al., 2010). Chronic inflammation is also a predominant feature of treated human immunodeficiency virus (HIV) infection (Lederman et al., 2013; Deeks et al., 2013). Compared to age-matched HIV-negative subjects, persons with chronic HIV infection are at higher risk to develop non-acquired immune deficiency syndrome (AIDS) related chronic diseases (Guaraldi et al., 2011), and several studies have shown an association between chronic inflammation and higher cardiovascular risk and overall mortality (Kuller et al., 2008, Duprez et al., 2012). Recently, the investigators performed a pilot study of moderate physical activity that enrolled sedentary HIV infected subjects treated with combination antiretroviral treatment (cART), consisting of brisk walking, with or without strength exercise. Overall, after 12 weeks of training cholesterol profile and soluble and cell inflammatory markers improved significantly. However, because of the considerable individual variability in exercise responses, a program of physical activity needs be adjusted on an individual basis to be most effective. During recent years, the use of mobile technologies has been implemented for health monitoring interventions, including exercise. We hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness. The investigators hypothesized that the use of a mobile application will favour engagement to exercise by providing motivational inputs, and therefore adherence, and, as a consequence, an improvement of physical fitness. Therefore, the aim of this project is to improve health and quality of life of patients living with HIV through self-empowerment by use of an innovative mobile application, in order to assist and monitor individualized program of physical activity and diet recommendation. OBJECTIVES Primary To compare the improvement of physical fitness between the EG and CG groups after 16 weeks of training. Secondary To compare the improvement of the following characteristics between the EG and CG groups after 16 weeks of training: 1. anthropometry, 2. Blood lipids, 3. Inflammatory markers, 4. Quality of Life, 4. Mood State. ENDPOINTS Primary The primary objective will be assessed by the proportion of subjects with an improvement from baseline of 15% of maximal oxygen consumption (O2max) through 16 weeks of training. Secondary The secondary endpoints will be assessed by the 16-week changes in the following measures: 1. BMI and %Fat Mass, 2. Blood Total-, LDL-, HDL-Cholesterol, 3. Blood IL-6, hs-PCR, d-Dimer, IL-18; myostatin; T-cell activation markers, 4. F12 questionnaire, 5. Profile of Mood State questionnaire.
This is a 2-part, multicenter, open-label, randomized study of dinutuximab and irinotecan versus irinotecan alone in subjects with relapsed or refractory small cell lung cancer (SCLC). Part 1 of the study involves intrasubject dose escalation to evaluate the safety and tolerability of dinutuximab in combination with irinotecan. Part 2 of the study is designed to determine whether dinutuximab plus irinotecan prolongs overall survival (OS) compared with irinotecan alone. Subjects in Part 2 will be randomized in a 2:2:1 fashion to 1 of 3 treatment groups: (A) irinotecan; (B) dinutuximab plus irinotecan; or (C) topotecan. Randomization will be stratified by duration of response to prior platinum therapy (relapse-free period <3 months or ≥3 months).
Carbohydrate-based products can influence the post-prandial glycemic response differently based on their ability to be digested, absorbed and to affect rises in plasma glucose. Pasta is one of the major carbohydrate-rich foods consumed in Italy. Studies from the literature describe a lower glycemic response after the consumption of pasta compared with other wheat-based products, such as couscous. Among the factors affecting post-prandial glycemia after consumption of carbohydrate-based products, the technological process represents a central one. In fact, the different technological processes alter the food matrix which can affect the post-prandial metabolism of glucose and insulin differently. Thus, the present study aims at investigating the effect induced by the principal steps of the process of pasta production on the reduction of post-prandial glycemic and insulinemic responses compared to a similar durum wheat based product, couscous.
The present study aim to assess the effect of an interactive web decision aid on informed choice - measured via knowledge, attitudes and intentions concerning breast cancer screening - comparing the decision aid with a standard information provided via web.
The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.
Background High-flow nasal cannula (NHF) are a promising tool for administering oxygen to critically ill patients with high respiratory demand. Prone positioning (PP) is a simple and cost-effective strategy that since 1980s has been used in mechanically ventilated patients with acute respiratory failure to treat oxygenation impairment. A large randomized study detected a relevant survival benefit by prone positioning in patients with moderate to severe acute respiratory distress syndrome (ARDS) undergoing invasive mechanical ventilation and managed with the ARDS network PEEP-FiO2 table strategy. Theoretically, PP may benefit spontaneous breathing patients too, but data concerning its application in such context are limited to small case series and a retrospective study. The investigators designed a pilot feasibility study to assess the safety and efficacy of prone positioning in acute hypoxemic respiratory failure patients noninvasively treated with NHF. Methods Patients: 15 adult hypoxemic (PaO2/FiO2<200 mmHg with respiratory rate greater than 25 breaths per minute) non-hypercapnic patients with acute respiratory failure. PaO2/FiO2 will be assessed while the patients is receiving 50 L/min of 50% oxygen via a standard face mask for a 15-minute monitoring period at study entry. Protocol Eligible patients will undergo NHF for 1 hour in the supine semi-recumbent position (baseline, BL). Afterwards, each enrolled patient will be placed in the prone position for 2 hours. After a 2-hour PP period, the patient will be rotated and will undergo 1 hour of NHF in the semi recumbent supine position (Supine step). Measurements Patient's demographics will be collected at study entry. At the end of the monitoring period, and then on a hourly basis the following data will be collected: - Respiratory rate, SpO2, pH, PaCO2, PaO2, SaO2, PaO2/FiO2; - Heart Rate, arterial blood pressure; - Dyspnea, as defined by the VAS dyspnoea scale; - Discomfort, as defined by a visual analogic scale (VAS) adapted to rate the procedural pain of ICU patients; - End expiratory lung impedance (EELI), tidal volume distribution, global and regional lung dynamic strain (Change in lung impedence due to tidal volume/ELLI). - Work of breathing, assessed by pressure-time product (PTP) of the esophageal pressure and inspiratory swings in this signal. - Occurrence of pendelluft phenomenon The number of adverse events will be also recorded for each study step.
A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is chosen as primary outcome measure and a sample size of 10 per group is required. The rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.