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.
Pre test and post test questionnaire for evaluation of skills and teamwork capacities in PPH management
The present study will be the first to compared dental plaque quantitation between an oscillating-rotating electric toothbrush and a manual toothbrush with a new QLF technology.
Multicenter retrospective study including all consecutive patients treated by PMEG using a standard modification technique of Valiant Captivia (Medtronic, Minneapolis, MN-USA).
The goal of this clinical trial is to learn if simulator-based training will improve interventional cardiology fellows' skills and will improve patient outcomes. The main questions it aims to answer are: - Does this training improve specific operative parameters recorded during initial coronary interventions performed as first operators under senior supervision? - Will major and minor procedural complications be reduced after simulator-based training? Interventional cardiology fellows in their first year of training will be randomized between standard master-apprentice training or simulator-based training before starting their cath lab period. They will be supervised during their cath lab period as first operators by senior interventional cardiologists. During their first 50 procedures performed as supervised first operator, specific procedural data will be collected.
The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.
Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease, ranging from pure steatosis to non-alcoholic steatohepatitis and ultimately to liver cirrhosis. In order to study the association between NAFLD and nephrolithiasis while minimizing the confounding effect of metabolic syndrome, we investigated the impact of different degrees of NAFLD severity on potential risk factors for stone formation.
The research project OutProFeed - Italy: Routine outcome monitoring and feedback informed therapy in Italy: 1st Italian RCT large population study, represents the first Italian randomised controlled trial (RCT) to evaluate the effectiveness of feedback-informed psychotherapy (FIT) to improve patients mental health outcomes and psychotherapy processes through the use of the digital platform Mindy. The following project was awarded PRIN 2022 funding by the Ministry of University and Research (MUR). This project has the University of Bergamo as lead partner, with the auxiliary participation of the University of Palermo and the Polytechnic University of Milan. Given the innovative-experimental nature of the following research project, a digital platform -Mindy- will be used, which allows the recruited professionals (once registered) an all-round management of all the professional activities inherent to the psychologist/psychotherapist profession (informed consent, online therapy, administration of psychometric instruments, etc.) and which also facilitates the administration of psychometric instruments. ) and which also facilitates data collection, subsequent analysis and Routine Outcome Monitoring (ROM) and Feedback Informed Therapy (FIT) procedures with ad hoc charts and digital tools, in accordance with the guidelines dictated by the GDPR regulations on health and clinical data. Each therapist involved in the project, after having received guidance on the procedures and after having been instructed to use the platform will involve 5 new patients in the following project. The only inclusion criteria for patients are the following: I) Being of legal age II) Not having a diagnosis of psychosis and/or neurocognitive disorders III) Consent to participate in the following research project IV) Being a new patient (new or less than three sessions carried out) We will randomly assign the previously recruited psychotherapists and their patients to one of three conditions: (1) treatment as usual (TAU) in which therapists and patients proceed with psychotherapy as they normally would without receiving any initial training and using only Mindy as a simplified digital folder (2) process and outcome monitoring (OPM) in which patients will complete process and outcome measures related to each psychotherapy session therapists will receive basic feedback without Clinical Support Tools on these measures, they will use the Mindy platform as a medical record and will not receive specific training on FIT (3) process and outcome monitoring with feedback (OPM-F) where patients will complete process and outcome measures related to each session and therapists will receive feedback on the patient progress and experiences of the therapeutic alliance with specific training on feedback informed therapy (FIT) and will use the Mindy platform with all feedback and Clinical Support Tools information, They will also receive monthly supervision/coaching (for three months) to complete the FIT and ROM training on-going, with practical discussion of the most difficult clinical cases and possible solutions to be implemented in therapy. Recruitment of therapists will take place with the strategic participation of a pool of MIUR-recognised Schools of Specialisation in Psychotherapy (https://www.miur.it/ElencoSSPWeb/). Professionals qualified to practise as psychologists who are in their third year of the Schools of Psychotherapy will be selected, as well as therapists who already have a regular diploma of specialisation in psychotherapy recognised by the MIUR (https://www.miur.it/ElencoSSPWeb/), and who are in active practice. There will be no restrictions on the type of psychotherapy used by the professionals who will be recruited (the only criterion for inclusion is that it must be psychotherapy for a mental health issue). Therapists will not be aware of the randomisation procedure to reduce bias (Zelen design). Specifically, for the following research project we will use data from a maximum of 15 sessions (endpoints) carried out by all therapists of the 3 groups with the Clinical Support System only for the therapists of the group (OPM-F) who, as previously mentioned, will receive ad hoc training; furthermore, various instruments (described in the special section Instruments) will be compiled through the functional use of Mindy and in detail (cadence, purpose and research hypotheses) in the complete protocol in the next section. Finally, through the administration of special questionnaires, factors indicative of therapists aptitude and competences for the use of digital tools in professional practice will be collected in order to obtain statistical clusters that can be used as independent or control variables.
Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF <40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance.
Gastroenteropancreatic neuroendocrine neoplasms (GEP-NENs) represent the most common NeuroEndocrin Neoplasms (NEN) site, comprising 55-70% of all NENs, and they are extremely heterogeneous diseases in terms of clinical presentation and aggressiveness. In recent years there has been a significant increase in the incidence of such neoplasms, partially due to incidental findings of small indolent lesions. However, the behavior of GEP- NEN is variable and mainly dictated by some factors as age, sex, histologic grade, primary site, and stage at diagnosis1. As for grade which is defined by the proliferative activity as measured by mitotic count or ki67 staining, some 75% of neoplasms fall into the G1 grading category, 15% into the G2 category, and 10% into the G3 category. The probability of developing metastases is directly correlated with grading. In addition, the grading of GEP-NENs is also correlated with the type of differentiation of the neoplasm (well differentiated or poorly differentiated). Managing the complexity of this type of neoplasm has made it necessary to stratify patients into progression risk classes. The therapeutic approach is accordingly defined, and may include different treatments (surgery, loco-regional, targeted therapies, chemotherapies,...). Among treatments, the most widely used for patients with well-differentiated NENs are somatostatin analogs (SSAs), targeted therapies, and the combination of oral capecitabine and temozolomide. Systemic intravenous chemotherapy is instead employed in a subset of G3 neoplasms, especially if poorly differentiated.
Syncope is a common presenting condition. Pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. However, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. It is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. It is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ECG during Tilt Table Test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study.