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.
Previous monocentric experiences have already highlighted the role of preoperative cardiac imaging, in particular of cardiac magnetic resonance (CMR) and tomography (CT), in improving the ablation results of scar-related ventricular tachycardia (VT). A better characterization of scar obtained with high quality CMR images and post processing data with creation of maps exploring the heart in concentric layers from the endocardium to the epicardium could allow a personalized and more precise approach to this pathology. Aim of the study - Evaluating the feasibility and possible benefit of CMR-guided ablative approach (group 1: ablation of the "anatomical" channels of heterogeneous tissue within the scar) compared to CMR-aided approach (group 2: ablation of the "electrical" conduction channels within the scar) and standard approach (group 3: ablation guided by an electro-anatomical system without the aid of CMR) in a multi-center Tuscan study. What would add the project to what we know - The achievement of the objectives by the project would allow to propose a personalized ablation on the basis of the scar characterization and would allow a better efficacy, efficiency of the procedure and probably also a safer treatment
The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)
Adequate bowel preparation for colonoscopy has an extremely relevant impact on diagnostic yield and procedural success. The guidelines recommend an adequate colon cleansing rate of at least 90% of procedures. It has been shown that patients with inadequate colon cleansing history have a high probability of not reaching an adequate bowel preparation again. Surprisingly, no evidence-based recommendations are available regarding bowel preparation in the patient with inadequate colon cleansing history. Therefore, identifying the factors associated with repeated inadequacy of bowel cleansing is crucial in order to define the best preparation strategy in this subset of patients. The implications for patients and for healthcare system are many: improving the quality of bowel preparation would reduce the need to repeat colonoscopy and the risk of conducting unreliable examinations. Furthermore, it would reduce the costs for the healthcare system by avoiding to overload endoscopic units. Inclusion criteria: Outpatient and hospitalized patients, adults, candidates for colonoscopy for any pathology, as part of the normal care process, with the need to repeat bowel preparation due to inadequate cleansing. Exclusion criteria: - Emergency regime - Inability to obtain consent - Refusal of the patient Primary end-point: Identification of factors independently associated with repeated inadequate colon cleansing after inadequate bowel preparation at previous colonoscopy, and consequent development (and validation) of a predictive model. The colon cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigns a score from 0 (presence of solid stools) to 3 (excellent visualization of the colonic mucosa) for each of the three main segments of the colon, i.e. right colon, transverse colon and left-rectum colon. Colon cleansing will be judged inadequate in case of a total score <6 or a score <2 even in only one of the colic segments. Secondary end-point: • Assess the prevalence of repeated inadequate bowel cleansing in the patient with previous inadequate cleansing
Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by falls and oculomotor disturbances. Several clinical trials are currently evaluating the efficacy of new pharmacological compounds in slowing disease progression. Yet, both early diagnosis and evaluation of disease progression remain challenging. Study aims include verifying if specific motor, cognitive, language, cerebrospinal fluid and imaging assessments represent reliable biomarkers of PSP diagnosis, phenotypization and progression over 1-year follow up. Motor evaluation will include recordings from wearable sensors. Expected results include 1) improvement of PSP diagnosis and phenotypization; 2)improvement of evaluation of disease progression in the context of clinical trial; 3)enhancement of strategies to prevent falls and fractures in such patients leading, in turn, to significant cost savings for the National Health System.
Postural and balance disorders are common in neurological disorders. They are often associated with reduced mobility and fear of falling, which strongly limit independent activities of daily living (ADL), compromise the quality of life and reduce social participation. Here the investigators apply an existing software solution to: 1) obtain biomarkers of gait deficits in 5 neurological conditions, 2) develop an automatic procedure supporting clinicians in the early identification of patients at high risk of falling as to tailor rehabilitation treatment; 3) longitudinally assess these patients to test the efficacy of rehabilitation. High-density electroencephalography (EEG), and inertial sensors located at lower limbs and at upper body levels will be used to extract the most appropriate indexes during motor tasks. The ultimate goal is to develop cost-effective treatment procedures to prevent recurrent falls and fall-related injuries and favour the reintegration of the patient into everyday activities. The first hypothesis of this study is that clinical professionals (e.g., medical doctors and rehabilitative staff) would strongly benefit from the possibility to rely on quantitative, reliable and reproducible information about patients motor deficits. This piece of information can be nowadays readily available through miniaturized wearable technology and its information content can be effectively conveyed thanks to ad hoc software solution, like the A.r.i.s.e. software. The second hypothesis of the present study is that early identification of patients at high risk of dependence and the subsequent application of personalized treatment would allow for cost-effective treatment procedures to favor the autonomy into everyday activities. The results of this project could represent a valuable support in the clinical reasoning and decision-making process.
This retrospective-prospective longitudinal observational study was designed to evaluate the role of bedside lung ultrasound per se and in association with hemogasanalysis parameters in predicting the severity of COVID-19 patients in the Emergency Departement (ED). Retrospective data regarding patients who presented at the ED of IRCCS San Raffaele Hospital from 10/11/2020, together with those acquired by the observation of patients who will access to the ED until 10/05/2021 will be collected, configuring a total enrollment period of 6 months. Clinical informations about patients' medical history will be recorded, with particular focus on the type and date of onset of the symptoms. The diagnostic and therapeutic strategy will be chosen according to the current standard of care. Results of bedside lung ultrasound, together with vital parameters, blood gas analysis, laboratory and other findings will be recorded. The primary outcome will be defined as patients' outcome at time of discharge from the ED, in terms of intensity of required care (home discharge, low or high-intensity care hospitalization, death). Secondary outcomes will be patients' prognosis 30 days after access to ED and the required intensity of care (eg need for non-invasive ventilation, oro-tracheal intubation).The follow-up 30 days after access to the ED will be evaluated by telephone survey or by consulting medical records.
An upfront-intensified treatment combining all the three active cytotoxic agents in metastatic colorectal cancer (mCRC) including fluoropyrimidines, oxaliplatin, irinotecan (FOLFOXIRI) plus antiangiogenic blockade with bevacizumab significantly improved survival. No biomarkers are available for predicting sensitivity/resistance to single chemotherapeutic drugs, the simultaneous delivery of all active chemotherapeutic agents might overcome resistance to single drugs. Temozolomide has modest but non-negligible activity (about 10%) in chemo-refractory patients with MGMT methylated mCRC. The response rate to temozolomide-based therapy in pretreated patients is increased to up to 20% when restricting the focus on those with MGMT IHC-negative/MGMT methylated and MSS cancers. Clinical and preclinical synergy has been reported for combination of temozolomide with irinotecan and fluoropyrimidines. Temozolomide could be regarded as a "targeted" chemotherapy for patients with MSS and MGMT silenced tumors. In this subgroup of patients, an intensified triplet upfront regimen including temozolomide, fluoropyrimidines, irinotecan, associated with bevacizumab, could be a novel combination in molecularly super-selected mCRC patients. Moving from this, the investigators designed this open-label, monocentric, phase 1b study evaluating the safety of the combination regimen 5-fluorouracil, leucovorin, irinotecan, temozolomide and bevacizumab in patients with MGMT silenced and MSS mCRC. The study will consist in a dose-escalation assessment of the safety of the treatment in subjects with previously untreated MGMT silenced, MSS mCRC. A 3 + 3 design will be used to assess the maximum tolerated dose (MTD) or maximum tested dose of the combination FLIRT-bevacizumab.
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients with leg ulcers. The aim of LUCE - "Leg Ulcers Standards of Care Enhancement" clinical trial is to verify the clinical efficacy of a portable battery-powered device blue LEDs based. This study aims to compare the existing SOC (consisting in two visits per week) to a protocol that requires only one visit per week, during which the EmoLED treatment is administered in addition to the current therapy. It is expected to register a difference in efficacy between EmoLED Group and SOC Group, in terms of "healing rate", intended as a reduction of the wound area, but also as a progress, in a broad sense, of the overall clinical situation of the lesion, in terms of pain and quality of life. -Endpoint- The primary endpoint is the comparison of the outcomes in terms of healing rate of lesions treated with SOC (SOC Group) versus lesions treated with EmoLED (EmoLED Group), on week 16th. Patients 80 patients will be recruited (40 patients per group), following these inclusion/exclusion criteria: Inclusion criteria: - Subjects suffering from venous and mixed skin ulcers; - Presence of a lesion < 100 cm² of area and < 1 cm in depth; - Men and women ≥ 18 years old; - The patient must be able to understand the aims of the clinical trial and provide informed consent in writing; - Chronicity of the lesion: at least 8 weeks. Exclusion criteria: - Patients who participated in clinical trials about skin ulcers healing during the previous month; - Patients who are not able to understand the aims of the trial; - Patients with pressure ulcers; - Patients with diabetic foot ulcers; - Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures); - Patients with clearly infected ulcers or with systemic infection; - Patients with ulcers caused by critical ischemia; - Patients with a self-harm past that can purposely alter the process of healing; - Patients with psychiatric disorders; - Pregnancy or breast feeding; - Patients with neoplasms or other diseases involving the use of cytostatic or immunosuppressive drugs; - Patients with limited lifespan; - Patients with photosensitizing illnesses or that take photosensitizing drugs. All inclusion and exclusion criteria must be satisfied before recruitment. Any concomitant phar-macological therapy must be maintained. -Medical and surgical procedures- The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied. Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic la-tex-free bandage will be carried out. The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion. In case of multiple lesions matching with both inclusion and exclusion criteria, they will be all treated following the same protocol, depending on the group to which the patient belongs; in this case the Principal Investigator will fill out a data-collection form and take pictures just of the le-sion with the wider area. -Follow up procedure- The patient is called upon to go to the follow-up check after 4 weeks from the healing or, other-wise, from the end of the trial (16 weeks). The follow-up visit will be used to confirm the occurred healing and verify the absence of relapses and/or undesirable effects (if the wound appeared completely healed) or to value the healing progress for the unhealed lesions.
This multinational, investigator-initiated, retrospective study aims to investigate outcomes of patients, who underwent transcatheter mitral valve implantation (TMVI), in comparison to those screened for TMVI but deemed ineligible, who subsequently underwent interventional mitral valve edge-to-edge repair, mitral valve surgery or medical/conservative therapy.
The most frequent cancer of the urinary tract is the bladder cancer (BC), in Italy its incidence reaches the 7% of all the new diagnosis of cancer, accounting for the fifth cause of death in the western countries, overall 140.000 new cases per year in Europe. In the year 2017, the Italian association for medical oncology (AIOM) recorded in our country about 21.700 new diagnosis of BC men and 5.300 in women. This data show not only a relevant gender disparity on the disease incidence (in 5th to 7th decade male incidence: 11-12% of all new diagnosis of cancer versus 1% in women) but also on the outcomes of treatment. Overall, the 30% of all the new diagnosis have a muscle-invasive (MIBC) onset, the female gender suffer a correlation with a more advanced disease at the time of first diagnosis. As a consequence, men have lower BC-related mortality when compared to women (p<0,001). This discrepancy in the mortality rate has been investigated by many authors, resulting in the evidence that female gender suffers higher risks, especially during the first two-years after the radical cystectomy. A comprehensive explanation has not been formulated yet, but a multiplicity of cofactors, including variations in the hormone receptors and tumor biology as well as the different anatomy between male and female, have been identified as potentially relevant. Another important issue in the pre-operatory management of female patients with BC is the misleading interpretation of hematuria. It seems to directly correlate with the evidence that women suffer a more advanced stage at diagnosis, and this element has been withheld in the list of relevant risk factors for prognosis. Nevertheless, a thorough analysis of their effect will only be possible in the future, as well-designed prospective and randomized clinical trials are currently not available. A part from the preoperatory disparity, it has also been described that men are more frequently candidates to an orthotopic urinary diversion, leading female patients to an irreversibly altered perception of personal integrity and body image, namely to a lower quality of life after radical cystectomy. The female anatomy has been considered as a limitation to continence recovery, resulting in preoperative counselling more frequently against in favor of ileal conduit or not-continent urinary diversions.