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 aim of the study is to evaluate the efficacy of an intensive handwriting treatment in Parkinson's Disease.
This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.
Aim of the study is to define if the auditory stimulation during stepping verticalization sessions with "Erigo" is able to modify the cerebral electric activity or improve consciousness in patients affected by vegetative state or minimally conscious state.
The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.
Observational, retrospective and perspective study with acute and chronic endpoints
Diminutive polyps, measuring between 1 and 5 mm, represent the vast majority of colorectal polyps encountered during colonoscopy. Since the chance of harboring advanced adenoma or carcinoma in this kind of polyps is very low, a "remove and discard" technique has been proposed. The differentiation between adenoma/non adenoma polyps is based on the use of endoscopes equipped with high definition, magnification and optical filters.
The proposed study is an observational, prospective, multicenter study of patients undergoing neoadjuvant therapy for medium-low rectal cancer. Recently the investigators have published the findings of a multicenter Italian phase II study showing that the rate of local recurrence, with a 3 year follow-up, is less than 5% in patients with baseline T2-3 mid-low rectal cancer who, after preoperative chemoradiotherapy (pCRT), showed a major clinical response and underwent a transanal local excision. Based on these results, an organ-sparing approach for patients showing a major clinical response is feasible without reducing the good results obtained with the standard treatment. While a phase III trial is the best way to compare the standard treatment with the organ-sparing approach (local excision or wait-and-see) it is impracticable and likely unethical. An observational study is therefore one of the best way to evaluate the impact that an organ-sparing approach may have on oncological outcomes, quality of life, and bowel function for patients with rectal cancer who, after a pCRT, show a clinical major/complete response. This phase II trial is designed to test the hypothesis that conservative treatments, in patients with low-mid rectal cancer who undergo a major or complete clinical response after neoadjuvant treatment, will be safe and effective compared to standard surgery. The investigators will compare rectum-sparing approaches to standard surgery, firstly in terms of rate of organ preservation at 2 years. Additionally they will compare survival outcomes (DFS, OS), stoma rates, clinical and tumor factors related to pathological complete response, correlation between major and complete clinical response. To add value, the investigators will measure QoL in patients treated with rectum-sparing approaches in comparison to patients treated with standard surgery (TME or abdomino-perineal amputation). Rectum-sparing approach can be considered clinically acceptable if percentage of conservation of the rectum at two years is not less than 50%. The collected data on 164 patients who underwent "rectum-sparing" allow to test the hypothesis that the rectum is preserved in 60% of patients with 80% power (exact binomial test for proportions, alpha = 5 %, 1 tail) and the study will be considered positive if it obtains a frequency of conservation of the rectum of not less than 87 cases. The analysis results will be reported in accordance with STROBE guidelines (von Elm et al., 2008). For all analyzes, continuous variables are described using the mean and standard deviation of position and appropriate measures when appropriate. Categorical variables will be described using the contingency tables.
Gait impairment is a common cause of disability in patients who have experienced a stroke and recovery of walking is a priority goal. Gait outcome is a significant factor that influences a patient's chance of returning to the social life activity and rehabilitation is an effective treatment for restoring gait in these patients. Learning to walk backwards correctly has been recommended to improve the movement components required for walking forwards. Several studies demonstrated that during backward walking the muscle activity is higher, more oxygen consumption, metabolic and cardiorespiratory activity are required and the same motor program is used comparing to during the forward walking. It has been suggested that backward walking therapy may be promoted as a treatment strategy to improve gait in stroke patients. The main goal of this project is to investigate the effectiveness of the backward walking therapy on gait improvement and spasticity in post stroke patients.
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.
The key goals of SPORTAX-NHS is to compare the phenotype of multiple system atrophy of cerebellar type (MSA-C) and sporadic adult onset ataxia of unknown aetiology (SAOA) and to determine the rate of disease progression in both groups including determination of the factors that predict the development of MSA-C vs. SAOA, and at which time after onset of ataxia, a reliable distinction between both disorders is possible. The planned study will also allow to collect blood samples and other biomaterials from patients with sporadic ataxia, which will be useful for future genetic and biomarker studies.