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.
BACKGROUND: Stay-at-home orders in response to the Coronavirus 2 (SARSCoV-2) have forced abrupt changes to daily routines. The aim of our study is to evaluate the impact of the Stay-at-home orders on the waiting list for bariatric surgery in our Department of Medical and Surgical during covid-19 pandemic. MATERIALS AND METHODS: In this observational retrospective study, from the 9th of March to 18th May 2020, the patients of our Department were invited to answer to a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices
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
Post craniotomy pain is defined as headache developed up to 7 days from a craniotomy, not otherwise explained. A moderate to severe pain affects from 60 to 84% of patients. Sphenopalatine ganglion block has been successfully used in patients with chronic or acute headache, facial pain and for transsphenoidal pituitary and endoscopic sinus surgeries. There are evidences that sphenopalatine ganglion block reduces vegetative responses to skull pin closure. This study aim to investigate feasibility and efficacy of sphenopalatine ganglion block in reducing pain after a neurosurgical supratentorial craniotomy.
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,
In patients with locally advanced rectal cancer (LARC), preoperative chemo-radiotherapy (CTRT) is considered the standard of care. Preoperative CTRT approach often results in a significant tumor downstaging and local control, with evidence of complete pathological response (pCR) rate of about 15% in high volume institutions. In high-risk LARC a new strategy called total neoadjuvant therapy (TNT) has emerged, in which systemic chemotherapy with fluorouracil and oxaliplatin (RAPIDO trial) or with the triplet FOLFIRINOX (as was used in the PRODIGE 23 study) is incorporated before or after the administration of short-course RT or neoadjuvant CTRT and prior to surgery. However, given the fact that TNT may represent an overtreatment for a subset of patients, additional therapeutic strategies are warranted to improve the outcomes also in patients with lower risk that are not good candidate for a TNT. In the era of personalized medicine, tumor molecular profiling may lead to the identification of therapeutic targets for pharmacological intervention potentially useful to enhance treatment outcomes. O(6)-methylguanine-DNA-methyltransferase (MGMT) repairs DNA damage induced by alkylating agents and MGMT inactivation due to promoter methylation confers enhanced sensitivity to alkylating agents such as temozolomide (TMZ). TMZ has modest activity in patients with MGMT-methylated pretreated metastatic colorectal cancer and responses are restricted to tumors with complete MGMT loss by immunohistochemistry (IHC) and microsatellite stable (MSS) status. Both capecitabine and temozolomide induces deoxythymidine triphosphate thymidine pool depletion might induce deoxyribonucleic acid (DNA)-double strand breaks and eventually apoptosis in rapidly dividing cells. On the basis of such evidences, there is a strong biological and clinical rationale for testing the addition of TMZ to capecitabine-based CTRT in patients with MGMT silenced and MSS technically resectable LARC. The aim of this trial is investigating whether the addition of TMZ to standard concurrent capecitabine-based long-course chemoradiation may increase pCR rate as compared to historical control in patients with locally advanced rectal cancer not candidate to TNT and molecularly selected for the presence of MGMT silencing and microsatellite stable status.
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.
This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use. Participants will have to inject the study medicine every day under the skin with a pen-injector. The study will last for at least 2 years and up to about 4 years. The length of time the participant will be in the study depends on if the study medicine will be available for purchase in their country.
Chronic Venous Disease (CVD) is a widespread clinical condition widely spread in the western countries that may negatively impact the quality of life (QoL) of affected patients. Chronic venous leg ulcers (CVLUs) are the most severe form of CVD, and several genetic and molecular alterations have been studied in order to understand the progression of CVD towards CLVUs. Chronic inflammation is a key element in CVLUs onset, and recently T helper 17 (Th-17) cells, a subtype of pro-inflammatory T helper (CD4+) cells defined by the production of a cytokine signature of which IL-17 represents the progenitor, seem to be related to several chronic disease. The aim of this study is to evaluate Th17- Gene Expression profile in patients with CVD and CVLUs.