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 "RIALTO-PRO" study aims to optimize the diagnostic and therapeutic algorithm for myocardial bridge (MB) patients, testing the diagnostic value of a full invasive diagnostic procedure, and, consequently, the prognostic value of a tailored approach. the study objective is to determine the diagnostic and prognostic value of a full-physiology approach strategy versus a standard approach strategy in patients with a MB. The "RIALTO PRO" study is a randomized, multicentre, prospective, open-label, superiority trial comparing a personalised versus standard management in patients with MB. Consenting and eligible patients will be randomised 1:1 to either a "full-physiology approach", consisting of a comprehensive diagnostic algorithm aimed at unmasking the main pathophysiological mechanism of myocardial ischemia and consequently a tailored treatment, or a "standard approach", consisting of angiographic evaluation of the tunnelled segment.
The purpose of this study is to test the safety and tolerability of BMN 351 in participants with Duchenne Muscular Dystrophy (DMD) with a genetic mutation amenable to exon 51 skipping.
The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).
The aim is to develop radiogenomics models to stratify patients into three main risk categories (Favorable, Intermediate, and Unfavorable) according to the ProMisE model (9) and use these models to predict the most prognostically relevant EC histopathological features (i.e. FIGO stage, degree of tumor differentiation, histotype, LVSI status, myometrial and cervical invasion, lymph node metastases). These models would support clinicians in personalizing surgical and adjuvant treatment choice among the options considered by the international guidelines.
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in extremely premature neonates. The study population includes babies born between 23 and 28 (27 + 6 days) weeks of gestational age and body weight between 500g and 1,500 g. Thirty-six subjects will receive one or three administrations of the three doses of EXOB-001 via the endotracheal route in phase 1. In phase 2, two dosages based on the results of phase 1 will be selected and a total of 203 subjects will be randomised to receive either EXOB-001 or placebo (saline solution). Infants will be followed up to 2 years of corrected age (end of study).
The objective of this clinical trial is to assess the impact of a music therapy intervention on reactive psychological components related to the risk of preterm birth in hospitalized pregnant women. The primary inquiries it seeks to address are: 1. Can a music therapy intervention during high-risk pregnancy mitigate reactive psychological components (perceived emotional state, state anxiety and trait anxiety, depressive symptoms, perceived stress) related to the risk of preterm birth in hospitalized pregnant women? 2. Does music therapy intervention during high-risk pregnancy positively influence the development of the attachment bond between the mother and the child? 3. How does the risk of preterm birth modulate the future attachment bond between mother and child? Participants will be categorized into three groups: a clinical experimental group (pregnant women at risk of preterm birth undergoing music therapy intervention), a clinical control group (pregnant women at risk of preterm birth receiving standard ward care), and a non-clinical control group (pregnant women with a physiologically progressing pregnancy). Upon signing the informed consent, all three groups will be required to complete five self-report questionnaires assessing perceived positive and negative feelings, depressive symptoms, state anxiety and trait anxiety, perceived stress, and the mother-fetus attachment bond. Subsequently, the clinical experimental group will undergo ten online music therapy sessions, while the clinical control group will receive routine ward care. Following the music therapy sessions, both clinical groups will reassess the aforementioned measures. The non-clinical control group will complete the same self-report questionnaires with the same timing as the clinical groups. All three groups will be contacted three months after childbirth to complete a self-report questionnaire evaluating the postnatal attachment bond. Researchers will compare the outcomes of the two clinical groups to address the first two research questions, while the comparison between the clinical control group and the non-clinical control group outcomes will be employed to answer the third research question.
The current project aims at assessing the impact of various cognitive telerehabilitation approaches on patients with Mild Cognitive Impairment (MCI) associated with neurodegenerative diseases, namely Alzheimer's disease (AD) and Parkinson's disease (PD). The study focuses on non-pharmacological interventions to maintain patients' residual functionality, limit disease progression, and improve quality of life for both patients and their caregivers. This longitudinal and multicenter study applies innovative cognitive telerehabilitation (TR) methods and evaluates their impact on functional parameters obtained with high-density electroencephalogram (HD-EEG) and resting-state functional magnetic resonance imaging (rsFMRI). The goal is to identify neurophysiological correlates of the effects of three different cognitive TR in individuals with MCI due to neurodegenerative conditions. The study aims to: - Identify correlations between improvement in cognitive performance and functional brain data. - Use acquired knowledge to develop neurologically guided TR approaches for broader use. The research will include patients diagnosed with MCI associated with neurodegenerative diseases. Primary outcome measures include changes in resting-state brain connectivity assessed through HD-EEG and rsFMRI. Secondary outcomes involve the assessment of changes in neuropsychological measures, caregiver burden, immediately after rehabilitation and after longitudinal follow-up. The study is designed to last 30 months, with follow-up assessments at three time points. The primary outcomes will be evaluated using rsFMRI and HD-EEG instrumental acquisitions, the secondary outcomes will be evaluated using clinical assessments and neuropsychological tests.
This is a prospective cohort study to assess the feasibility of the laparoscopic ultrasound examination, directly by surgeons, during minimally invasive gynaecological surgery. The secondary aims are to examine the learning curve for laparoscopic ultrasound examination and the performance score in obtaining high quality ultrasound images of anatomical parameters by a team of 5 gynecological laparoscopic fellows. The patients' medical history and symptoms will also be recorded to define whether these clinical data can influence the failure rate. With advanced technology, the conventional workflow can be simplified by using laparoscopic ultrasound probes directly by surgeons, to utilize the hospital resources efficiently and to reduce operating times. In this regard, we would like to demonstrate that the application of laparoscopic examination is feasible and easy to learn by surgeons. This innovative technique could open up multiple diagnostic and therapeutic opportunities for the patient, providing potential clinical information useful to the surgeon.
Postural instability has a major impact on the mobility and daily life activities of Parkinson's disease (PD) patients as it often leads to reduced mobility, insecure stance and falls. The aim of this study was to evaluate the effect of focal vibration on the static and dynamic balance of a group of Parkinson's disease patients with Hoehn and Yahr (HeY) stage II-III. They underwent three weeks of focal muscle vibration applied to the quadriceps, soles of the feet and trapezius muscles bilaterally in addition to conventional physiotherapy . The static and dynamic balance was assessed at baseline (T0), after 3 weeks of treatment (T1) and after 1 month from the last treatment (T2) with the Tinetti scale and stabilometry evaluations.
Growing evidence in literature is supporting the role of ultrasound scan (US) as accurate tool in diagnosis and staging of gynecologic cancers. In particular, different studies demonstrated the accuracy of US in assessing endometrial, cervical, and ovarian cancer in the primary setting. However, the number of studies investigating the role of US in the recurrent setting is limited. Moreover, there is no evidence in literature exploring the role of US in laterally-extended pelvic recurrences from gynecologic cancer, where the Magnetic Resonance Imaging (MRI) scan is still considered the most accurate tool.