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 safety and efficacy of donidalorsen in participants with HAE and effect of donidalorsen on the quality and pattern of HAE attacks and their impact on quality of life (QoL).
Primary Objective: To assess the efficacy of the infrared therapy patch (ITP) FIRTECH for treating participants suffering from mild to moderate acute low back pain. Secondary Objectives: - To assess the efficacy of ITP FIRTECH on participant disability - To assess the efficacy of ITP FIRTECH on the degree of participant mobility - To assess the safety of ITP FIRTECH
patients underwent inguinal hernia repair; Group A patients received Subarachnoid anesthesia; Group B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon; Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,
The study objective is to assess the efficacy and safety of cenegermin (rhNGF) ophthalmic solution at 20 mcg/mL concentration administered three times daily for 4 weeks in patients with severe Sjogren's dry eye disease (DED) who are under chronic treatment with topical Cyclosporine A (CsA).
Social participation and social relationships are relevant aspects of older adult's psychosocial well-being. In this regard, specific interest is devoted to Information and Communication Technologies (ICT) which enable to connect people and to support their social participation. Despite the number of older Internet users constantly increased in the last decades, older adults still display reduced Internet access compared to younger generations. Italian elderly people are severely penalized by this "gray digital divide". The pandemia due to COVID-19 spread has exasperated the situation, leading to the paradox of having people putatively most beneficent of use as those most excluded, due to scanty of competencies and of suitable and agreeable learning occasions. The Cyber School for Grandparents is an innovative intergenerational educational program aimed to bridge the digital divide by training secondary school students (aged 15-17 years) to become cyber tutors for their grandparents. The intervention will take place during the 2021/2022 school year, as part of the curricular activities of 3 classes at the local Human Science High School. The intervention was designed to be personalized and inclusive, in order to meet the need of each student-senior dyad, regardless of their starting digital skills and attitudes toward technology. The primary aim of the present mixed-method feasibility study is to qualitatively evaluate students' participation and learning throughout the course and to measure grandparents' pre-post changes in mobile device actual use, self-reported proficiency and attitudes. Secondly, eventual pre-post changes on aging stereotypes and psychosocial well-being of the participants will be explored.
The remote cognitive assessment has the advantage of reaching people despite the restrictions due to the pandemic, so it is of fundamental importance both in the treatment of dementia and the research context. The scientific literature on the feasibility, acceptability and validity of remote neuropsychological assessment provides promising indications. However, the limitations related to access and familiarity with technologies in elderly populations, and to methodological aspects (e.g. the not-controlled environment, the validity of the remote assessment compared to the in-person assessment) remain to be clarified. For the present observational feasibility study, 58 older adults (65-85 years), randomly extracted among 93 eligible participants, will be recruited among donors of our Brain Bank. Participants will undergo both face-to-face and remote testing (via phone calls or videoconferencing) sessions in a counterbalanced cross-over design. The study will target (1) the recruitment rate in a study on remote testing, (2) the acceptability of remote cognitive tests and the procedures for delivering remote testing, (3) the comparability between remote and face-to-face performances on neuropsychological tests.
About 20% of strokes are caused by emboli deriving from a carotid plaque. In symptomatic patients with carotid stenosis grater than 70% the Carotid Endarterectomy (CEA) reduces stroke risk by about 75% and is generally accepted as being cost effective. However also in these cases there is a part of the population that, according to the morphological plaque characteristics, could better benefit from a conservative medical treatment. Improving the Best Medical Treatment, the situation seems to be even less clear in asymptomatic patients, where probably it would need to treat at least 32 patients in order to prevent one single ictus. Different parameters have been considered in order to determine, among the asymptomatic patients the ones that more than others could benefit from a surgical revascularisation instead of a medical treatment. Between these parameters, the quality of the plaque (vulnerability) and the micro-embolic signals (MES) detection with the Transcranial Doppler (TCD) Holter seems to be the most relevant. Another interesting aspect is trying to establish whether plaques can determine a different embolic risk in relation to the different histological findings. Therefore, it seems interesting and reasonable trying to establish a correlation between these two parameters in asymptomatic patients as in the symptomatic ones in order to make more and more appropriate a surgical plaque removal according to the specific risk of each patient in a set of tailored surgery. It consists in a descriptive observational study, since it intends to describe the embolic signals detection (MES) counted in automatic way with the TCD Holter, in patients affected by carotid stenosis, before and after the surgical operation. In particular it consists in a monocentric, longitudinal, prospective cohort study since it intends to analyse a group of patients (already candidates to CEA) that experiences a specific event (MES) before and after the surgical plaque removal, in a precise span of time. Since the treatment, removing the plaque, should remove the embolic focus too, a significant reduction of microembolic signals in post-operative time is expected. This reduction has been esteemed around about the 70% among candidates to CEA. Patients taken on responsibility of the equipe will undergo an ultrasonographic investigation for the carotid stenosis, histological characterization of the plaque based on the Gray-Weale classification and TCD-Holter for MES.
To compare surgical outcomes of oncologic patients that underwent conventional laparoscopy and percutaneous laparoscopy for cryopreservation of ovarian tissue.
Primary objectives - To compare the efficacy of cenegermin vs vehicle in Schirmer I test (without anaesthesia) >10mm/5min at Week 4 by testing the superiority. - To compare the efficacy of cenegermin vs vehicle in Symptom Assessment in Dry Eye questionnaire (SANDE) global score at Week 12 by testing the superiority. Secondary objectives - To compare the efficacy of cenegermin vs vehicle in Schirmer I test at Week 4, 8, 12 and 16 by testing the superiority. - To compare the efficacy of cenegermin vs vehicle in Cornea and conjunctiva vital staining with fluorescein (National Eye Institute [NEI] scales) at Week 4, 8, 12 and 16 by testing the superiority. - To compare the efficacy of cenegermin vs vehicle in Tear Film Break-Up Time (TFBUT) at Week 4, 8, 12 and 16 by testing the superiority. - To compare the efficacy of cenegermin vs vehicle in SANDE scores at Week 8, 12 and 16 by testing the superiority. - To compare the efficacy of cenegermin vs vehicle in worsening in symptom scores (SANDE) and/or NEI score at Week 4 by testing the superiority. - To compare the efficacy of cenegermin vs vehicle in impact of dry eye on everyday life (IDEEL) questionnaire at Week 4, 8, 12 and 16 by testing the superiority.
The study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with COVID-19. Specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (PEEP) and two different levels of inspiratory oxygen fraction (FiO2) on gas exchange by analyzing shunt and dead space. Furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of PEEP.