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 an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome.
Introduction: Patients with chronic liver diseases are usually thin as a result of hypermetabolism and malnutrition expressed by reduced levels of leptin and impairment of other adyponectins such as visfatin. Aims: To evaluate the metabolic and inflammatory effects of intravenous high-dose furosemide plus hypertonic saline solutions (HSS) compared with repeated paracentesis and a standard oral diuretic schedule, in patients with cirrhosis and refractory ascites. Methods; All consecutive cirrhotic patients with refractory ascites unresponsive to outpatient treatment will be enrolled . Enrolled subjects will be randomized to treatment with intravenous infusion of furosemide (125-250mg⁄bid) plus small volumes of HSS from the first day after admission until 3 days before discharge (Group A ), or repeated paracentesis from the first day after admission until 3 days before discharge (Group B, ). Plasma levels of ANP, BNP, Leptin, visfatin, IL-1β, TNF-a, IL-6 were measured before and after the two type of treatment.
Oocyte accumulation by vitrification is a valid strategy to increase the number of available embryos for biopsy and the number of viable euploid embryos to transfer after preimplantation genetic testing.
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.
To evaluate the efficacy of long-term treatment with 2 mg aflibercept via different intravitreal (IVT) treatment regimens to participants with DME pretreated with 2 mg aflibercept every 8 weeks after 5 initial monthly injections for approximately 1 year or more (according to the EU label for the first year of treatment)
Cardio-metabolic risk factors include obesity, physical inactivity, smoke, alcohol abuse, high blood lipids or sugar and arterial hypertension. Systems for self-learning and self-monitoring may help people improve and maintain a healthy lifestyle through tailored suggestions about diet, weight control, physical activity, fatigue,stress. SEMEOTICONS exploits the human face as an indicator of individual's health status and translates signs obtained from the face using contactless sensors into measures and descriptors to be automatically evaluated by a an interactive smart mirror. This "Wize Mirror" extracts descriptors from videos, images and gas concentration signals and integrates them in a virtual model used to compute and trace the evolution of an individual's wellness index. A health diary enables each individual to evaluate and personally relate his/her lifestyle to his/her well-being. Coaching messages are provided, in relation to the evolution of the wellness index and of each descriptor, to provide useful suggestions on correct lifestyle self-monitoring. The purpose of this study is assess the accuracy of the information derived from the Wize Mirror in expressing the health status of the individual. The reproducibility and repeatability study will evaluate whether measurements are stable over short time spans and whether they are influenced by meals light and temperature conditions. To verify whether the Wize Mirror is able to detect variations in physical and emotional health status with appropriate lifestyle changes, the validation study will cross-check measurements from the Wize Mirror against reference clinical tests at enrolment and after 3 months of personalized suggestions for healthy behavior. Reference tests include - Physician visit - Measurement of blood oxygen content and skin end products of sugar metabolism,body composition, energy expenditure, vascular function - Laboratory profile and exhaled gas composition - Questionnaires on quality of life and lifestyle (food, sleep, physical activity, smoking, alcohol, stress). Wize Mirror measures include - 3D reconstruction of face images for roundness, color, stress and fatigue - Heart and respiratory rate - Detection of skin sugar metabolism end-products and of eye lipid deposits - Small vessel vasodilating ability with local heating The results will allow to assess whether the Wize Mirror is easy to use and helpful for self-monitoring of cardio-metabolic risk.
Background. Patients with ST-Elevation Myocardial Infarction (STEMI) and hyperglycemia on admission have high rates of mortality (1). The management of hyperglycemic patients during STEMI is unclear. We evaluate whether the thrombus aspiration (TA) before primary percutaneous coronary intervention (PCI) may improve STEMI outcomes in hyperglycemic patients (2). Research Design and Methods. Consecutive 990 hyperglycemic patients with first STEMI undergoing quantitative coronary angiography were studied. Patients were categorized in two groups, either treated by thrombus aspiration v/s patients treated without thrombus aspiration. After discharge from the hospital, all patients will be managed and followed quarterly for 12 months month after event, as outpatients, to perform clinical evaluation, routine analyses and cardiovascular evaluation. The cardiovascular endpoint collected in both cohorts will include cardiac mortality, all-cause mortality and hospitalization for coronary disease and heart failure. Conclusions. We will attend improved outcomes in hyperglycemic patients treated by the TA before PCI, as compared to hyperglycemic patients treated only by PCI.
This is a Phase II, single-arm, multicentre study of Daratumumab (16mg/kg IV route) in adult patients with Light-Chain (AL) Amyloidosis who are not in VGPR or better after previous treatment. A sample size of 40 patients who meet all eligibility criteria will be enrolled to receive study treatment. Patients will receive treatment until either disease progression or toxicity has occurred with a maximum planned of six 28-day cycles. Daratumumab will be administrated every week for the first 2 cycles then. every 2 weeks from cycle 3 through cycle 6. Patients will also receive best supportive care (BSC) to mitigate Daratumumab side-effects, and to address underlying Amyloidosis, including blood product transfusions, antimicrobials, and (as appropriate) growth factors including granulocyte colony-stimulating factors for neutropenia, erythropoietin for anaemia, and/or transfusions for thrombocytopenia
Feasibility trial on the use of a hybrid optical device integrating time-resolved near-infrared spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) for measurement of cerebral oxygen metabolism and blood flow in neonates. The device wil be tested in four settings measuring: 1. Changes in cerebral oxygenation and haemodynamics after birth 2. precision and repeatability 3. The cerebral vaso-reactivity to arterial carbon dioxide 4. Assessment of the user-friendliness and loss of signal in routine care
Design: Open-label randomised multicenter international strategic trial of older women on combination antiretroviral therapy (cART) containing tenofovir-emtricitabine (TDF/FTC) with HIV RNA suppression for > 6 months to : 1. Immediate switch of TDF/FTC to tenofovir alafenamide-emtricitabine (TAF/FTC) while continuing the third antiretroviral agent.; 2. Delayed switch; with switch of TDF/FTC to TAF/FTC at 48 weeks while continuing the third agent. Follow up of all subjects to 96 weeks. Subject Population: The anticipated sample size is 128 HIV infected women aged 45-55 years (peri or early post menopause). . Primary endpoint: Percentage change from baseline bone mineral density (BMD) at the lumbar spine at weeks 48 and 96. Secondary Endpoints: BMD change at hip, trabecular bone score, estimated bone strength by high resolution peripheral quantitative computerized tomography (HR-pQCT), muscle quality, geriatric assessment; biomarkers of bone, immune activation and inflammation; HIV viral suppression; safety, lipid and renal function, cardiovascular risk scores at weeks 48 and 96. Expected Outcomes: To determine if a switch from TDF/FTC to TAF?FTC improves BMD to a degree correlating with a decreased risk of fragility fracture in aging HIV infected women. Secondary outcomes will assess bone strength using new imaging modalities, timing of switch, and renal health. This data will be used by health policy makers and providers to determine the proper use of TAF/FTC in the aging HIV population.