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 study aims to evaluate MSCopilot® Detect, a smartphone application for at-home monitoring of patients with Multiple Sclerosis (MS). The primary objective is to enhance and standardize remote monitoring of MS patients to accurately assess disease progression caused by either Relapse Activity Worsening (RAW) or Progression Independent of Relapses (PIRA). The study also aims to assess the safety, usability, and satisfaction of the solution. A secondary objective is to determine MSCopilot® Detect's ability to provide early detection of disease changes and predict changes in Expanded Disability Status Scale (EDSS) scores in more patients. Exploratory objectives include evaluating the relationship between MSCopilot® Detect composite and individual scores and other biomarkers such as MRI, soluble glial fibrillary acidic protein (sGFAP), and soluble neurofilament light chain (sNfL). Patients will be able to download the free MSCopilot® Detect app. They will participate in 1 inclusion visit and 3 follow-up visits, scheduled at 6 months, 12 months, and 18 months (an additional visit at 24 months may be scheduled if necessary). Every 3 months, patients will complete validated questionnaires regarding MS symptoms and quality of life and participate in digital tests designed to monitor MS symptom progression. The study will include 314 MS patients and will be conducted in the United States, Canada, Germany, Italy, Spain, Denmark and France
Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. The study aim to investigate the possible effects of ketogenic diet on intra- and peri-operative complications of right laparoscopic adrenalectomy in obese patients; researchers will analyze intra- and peri-operative outcomes among obese patients who underwent laparoscopic right adrenalectomy, comparing the two arms with and without ketogenic diet.
This project aims to improve the health care provided to people with major depressive disorder (MDD), a disease which is a top cause of disability worldwide. One of the main obstacles to a more effective health care in these patients is represented by clinical heterogeneity, which has not completely elucidated biological correlates. Using a large sample of people with MDD already recruited (n=29,400), the investigators develop a clustering algorithm based on genetic-environmental and brain imaging predictors aimed at identifying homogeneous MDD subgroups. The researchers will then link these subgroups with relevant health outcomes, such as disease recurrency and severity, well-being and functioning, risk of psychiatric and medical comorbidities (e.g. cardiovascular disorders). Replication in independent samples already recruited(n=1380) will prove the validity of the subgroups and expand their clinical characterization. The investigators will develop a classification tool to link the individual's characteristics to the relevant health outcomes and provide corresponding clinical recommendations. The prognostic support tool will be applied to newly recruited samples, feasibility and usefulness according to clinicians's opinion will be assessed (n=120, ongoing recruitment).
The aim of this prospective observational diagnostic study is to investigate the diagnostic accuracy od extrapelvic disease detection using Whole-body-MRI (WB-MRI) in patients with gynecologic cancer candidate to the pelvic exenteration.
The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast
The main objective of this clinical trial is to test the effects of the personalized intervention based on physical exercise, on clinical variables and circulating markers, in a population of employees of the University of Milan (UMilan). The HEBE study will include two phases: PHASE 1: All UMilan employees will be asked to voluntarily complete an anonymous online questionnaire, in order to gather information about their lifestyle (physical activity, diet, cigarette smoking, etc) (zero time: T0); at the end of the compilation, indications on how to improve the lifestyle will be provided. These indications will also be present and available for consultation in a special section of the site on the "HEBE" site, with UMilan domain (www.hebe.unimi.it). After 6 months, all UMilan employees will receive a second invitation to voluntarily complete the same questionnaire, in order to evaluate any changes, in terms of lifestyle improvement (time one: T1). PHASE 2: 100 eligible subjects who have expressed their availability in the initial questionnaire, will be identified to undergo a lifestyle improvement protocol based mainly on the prescription of a personalized exercise program, which will define modalities, intensity, duration, frequency and progression of the exercise. For each subject, at T0 and T1 (after 6 months), biological samples will be collected (blood, urine, saliva and nasal swab), which will be used to: i) set up a biobank shared by the members of the HEBE consortium; ii) identify biomarkers able to monitor the effect of physical exercise on the characteristics of the frailty under examination. Furthermore, both at T0 and T1 questionnaires will be completed and carried out clinical evaluations (anamnesis, physical examination, tests for the study of the autonomic nervous system, bio-impedance test, evaluation/estimate of maximal oxygen consumption, ECG).
The consequences of the Intensive Care Unit and the Covid-19 disease are still uncertain. However, many studies are bringing out often psychological and dramatic consequences for many COVID-survivor patients. Among the ex-covid patients discharged from our Intensive Care Unit and with at least one covid-related psychological consequence, we want to evaluate the effectiveness for long-term consequences of COVID-19 of mindfulness-based stress reduction (MBSR) or usual care.
Parkinson's disease (PD) is a neurodegenerative disease characterized by bradykinesia, rigors, and tremor at rest. Distinctive neuropathological signs include progressive loss of dopaminergic neurons in the Substantia nigra pars compacta (SNpc) and the presence of immunoreactive protein inclusions for α-syn, Lewy bodies (LB). The clinical phenotype is heterogeneous, both from a motor and non-motor point of view. Furthermore, the prognosis and response to drugs are highly variable and poorly predictable. To date, there are no biomarkers capable of early identification of clinical phenotypes and of predicting response to therapy. This constitutes a serious limit that probably represents one of the causes of the failure of the experimentation of the disease modifying therapies tested up to now (for example the anti-α-sin antibodies). Certainly, a deeper understanding of disease pathogenesis is needed to address these unsolved problems. Oxidative stress and inflammation have critical roles in PD, especially in the prodromal and early stages of PD, as they contribute to pathological progression and also trigger potentially devastating neuroprotective responses, especially in the early stages. Consequently, soluble mediators of these processes may represent potential markers of prodromal phases of the disease. Inflammation is a key factor in the initiation and propagation of a-syn aggregates and the contribution of microglial activation to a-syn pathology has been highlighted recently. Elevated a-syn specific T cell responses may be present years before the diagnosis of motor PD, suggesting a role of neuroinflammation in PD pathogenesis and early diagnosis. Furthermore, studies in rats overexpressing a-syn support the idea that reducing neuroinflammation could improve symptoms in early Parkinson's disease. In particular, drug-targeted anti-inflammatory approaches in a-syn rats prevent central and peripheral inflammation, as well as neuronal dysfunction and motor motor impairment. It is also increasingly evident that panels that combine different biomarkers, with a multimodal approach, are more sensitive and specific, better reflecting the complexity of pathophysiological mechanisms. In fact, the diagnostic sensitivity of some CSF biomarker panels of neurodegeneration in distinguishing between atypical parkinsonisms and Parkinson's disease has been demonstrated. These markers, as well as in the cerebrospinal fluid, can be measured in the serum, albeit with reduced specificity, and in exosomes of central origin, which have recently been described and analyzed also in cohorts of patients with Parkinson's disease. In addition to pharmacological approaches, attention has recently been paid to non-pharmacological therapeutic approaches, such as physical activity. In particular, studies on PD patients show that aerobic exercise improves motor performance by increasing BDNF levels and reducing inflammation. Retrospective studies have found that moderate to vigorous exercise in midlife may protect against PD. In 2018, a phase 2 study investigated the response to treadmill exercise performed at two different intensities (high and moderate) by de novo PD patients, reporting a beneficial effect of moderate treadmill exercise. Although aerobic exercise appears to be the most effective, several studies have used a variety of exercise programs to demonstrate options available for those who cannot physically perform aerobic exercise. In PD patients, physical activity also appears to have beneficial effects on cognition, mood, and sleep quality. Preclinical findings support the hypothesis that physical activity exerts its beneficial effect by increasing levels of BDNF and anti-inflammatory cytokines and inhibiting pro-inflammatory factors. In this study the investigators will measure changes in clinical scales and biomarkers in patients who undergo either an intensive physical activity protocol or continue their routine sedentary life.
The use of advanced technological tools able to exploit patient-centered "Real World Data", represents an innovative and fascinating challenge for the most modern personalized medicine paradigms. Monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction. The big data approach, being able to collect, manage and interpret large volumes of health data, eventually supported by artificial intelligence (A.I.) is therefore fundamental in this setting and may be translated in the next future in tangible advantages for the patients. Primary aim of the project is to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of a dedicated app and wearable technology (i.e. monitoring bracelet), as Electronic Health Record data harvesting devices. More specifically, the patients report experience measure of man/women affected by locally advanced non-small-cell lung cancer undergoing chemo(radio)therapy followed either by surgery or immunotehrapy (e.g. describing toxicity, instrumental activities of daily living and stress/coping levels) will be analyzed. The machine learning assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow up practices. This is an observational study with device, co-financed, monocentric study with a foreseen study duration of 36 months.
Upper limb motor impairment is one of the most common sequelae after stroke. Indeed, the recovery of upper limb sensory-motor functions remains one of the most important goals in stroke rehabilitation. In the last years, new approaches in neurorehabilitation field has been investigated to enhance motor recovery. The use of wearable devices combined with surface electromyography (i.e. sEMG) electrodes allows to detect patients muscle activation during motor performance. Moreover, sEMG is used to provide to the patients the biofeedback about their muscle activity during exercises execution to enhance motor control and motor recovery. The aim of the study is to define the efficacy of using REMO® (Morecognition srl, Turin,Italy) for hand motor recovery after stroke. A randomised-controlled trial will be conducted compared to a task-oriented training, in hand motor rehabilitation after stroke. 28 patients with diagnosis of first stroke event will be enrolled in this study. After randomization process, participants will be allocated in Experimental Group (REMO training) or in Control Group (task-oriented training). The participants will be assessed before and after the treatment and sEMG will be collected during 12 hand movements. The treatment will consist of 15 sessions (1h/day, 5day/week, 3 weeks). Finally, the sEMG of the same 12 hand movements will be collected from 15 healthy subjects to compare muscle activation with a normal reference model.