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.
For one-third of patients with drug-resistant epilepsy alternative approaches must be investigated in order to improve the quality of their life. A possible approach is to find automatic methods to detect/predict seizures, in order to adopt interventional actions to stop or abort the seizure or to limit its side effect. The main problem in this case is to evaluate the reproducibility of such methods and to standardize them, because there is a lack of availability of long-term electroencephalography (EEG) data. In this study we want to create a large long-term EEG database, called NEED (Neuromed Epilepsy EEG Database), whos aim is to give researchers a way to test their method in a large collection of data. The database will contain long-term EEG recordings of 200 patients as well as extensive metadata and standardized annotation of the data sets and will be made freely available for the download to the research community.
There is no specific therapy for acute kidney injury. It is presumed that supportive measures improve the care and outcome of patients with acute kidney injury. The investigators hypothesize that the implementation of a bundle of supportive measures adapted to patients undergoing major surgery reduces the occurrence of AKI. This randomized prospective multicenter trial is needed to investigator whether the implementation of the bundle of measures is effective to prevent AKI in high risk patients undergoing major surgery.
SINGLE CENTER PHASE III INTERVENTIONAL RANDOMIZED CONTROLLED TRIAL comparing efficacy and safety of enoxaparin at prophylactic dose (standard treatment) and enoxaparin at therapeutic dose (OFF-LABEL treatment) in 300 COVID-19 infected patients with moderate-severe respiratory failure (PaO2/FiO2<250) and/or increased D-dimer levels enrolled in different Units (Infectious disease, Internal Medicine, Emergency Medicine, Pneumology) of Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco (ASST-FBF-SACCO).
This is a multicenter open label phase II trial in patients with previously treated Marginal Zone Lymphomas. The aim of the study is to evaluate the efficacy and the safety of tafasitamab in combination with acalabrutinib. Twenty-four patients are expected to be enrolled and treated every 28 days with acalabrutinib and tafasitamab for 24 cycles. The study consists of two parts, which are performed sequentially. The first part is a safety run-in to evaluate the safety data once 6 patients (representing the 25% of the total cohort) have completed the first cycle of treatment. An Independent Data Monitoring Committee (IDMC) will provide an independent assessment of this evaluation. The second part starts after the outcome of this evaluation and will include the remaining 18 patients. The 6 patients of the safety run-in phase will be considered for the final evaluation of the study. Between 11 - 13 weeks, patients showing partial or complete response (PR, CR) will continue treatment, while patients showing stable disease (SD) will discontinue it. However, patients in SD who benefit from therapy may continue to be treated, after agreement between the Investigator and the Sponsor. Patients who complete the 24 cycles of treatment will enter the follow-up phase up to 3 years from patient's last study treatment dose (about 5 years from treatment start). Patients who discontinue treatment before cycle 24 for any reason will be followed for up to 3 years (every 6 months for the first year and yearly for the second and third year) from the patient's last study treatment dose. .
The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: - To characterize the safety profile of cemiplimab + ISA101b - To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)
The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.
Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 clinical trial. The study objective is to evaluate the safety and efficacy of two different concentrations (0.5% and 1%) of progesterone topical gel compared to placebo, when administered twice a day for 3 months (12 weeks) in patients diagnosed with moderate to severe dry eye syndrome.
Background: Many people think that people with mental disorders might be dangerous or unpredictable. These patients face various sources of disadvantages and experience discrimination on job interviews, in education, and housing. Mental health-related stigma (MHS) occurs not only within the public community, it is a growing issue among professionals as well. Aim: The investigators designed a prospective, observational, multi-centre, international study of 35 European countries to investigate the MHS among medical specialists and trainees in the field of general adult and child and adolescent psychiatry. Methods: An internet-based, anonymous survey will measure the stigmatizing attitude by using the local version of the Opening Minds Stigma Scale for Health Care Providers. Presentation of the Results: The results of the research will be published in an international peer-reviewed journal. Furthermore, the research team will present the results at national and international conferences.
Study Design: Evaluation of the psychometric properties of a translated, culturally adapted questionnaire. Objective: Translating, culturally adapting, and validating the Italian version of the Cumberland Ankle Instability Tool (CAIT-I), allowing its use with Italian-speaking population to monitor both state of health and functional limitation deriving from ankle instability problems, in order to evaluate the degree of severity, without using the comparison with the opposite limb. Summary of Background Data: Lateral ankle sprain is the most common injury during sports activity, often cause of disability and of numerous complications following repeated episodes, including chronic ankle instability (CAI), which affects 32% to 74% of the aforementioned cases. Growing attention is devoted to standardized outcome measures to improve interventions for injured population. A translated form of the Cumberland Ankle Instability Tool (CAIT), a simple and specific tool for diagnosing chronic lateral ankle instability with excellent psychometric characteristics of both reliability and validity, has never been validated within the Italian speaking population.
Primary Objective: - To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B). - To evaluate the efficacy of BIVV001 for perioperative management