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.
Transcatheter aortic valve implantation (TAVI) is an established treatment modality in patients ≥ 75 years old with severe symptomatic aortic stenosis after Heart Team evaluation (1). Patients with high/prohibitive surgical risk and life expectancy ≥ 1 years are candidates for TAVI according to the current guidelines (1). Nowadays is expected a progressive increase of TAVI procedures, in relationship to aging and increased life expectancy (2). Percutaneous, particularly trans-femoral, access represents the best choice in the vast majority of TAVI patients, because of its minimal invasiveness and reduced mortality, due to lower rates of periprocedural bleedings and strokes (3,4). Technical advancements, improving expertise and simplification of procedure, lead to reduction of vascular complications, still significant, and linked with worst patients' outcome (5). Some factors are considered to increase the risk of vascular complication: patient related and procedural related factors. Patient-related factors include female gender, severe vascular calcification and peripheral vascular disease. Procedural related risk factors consist of increased sheath to femoral artery ratio (SFAR) and TAVI centre experience/case load (5). Considering the last 10 years progress in techniques, devices technology and clinical outcome, a new Valve Academic Research Consortium (VARC) consensus manuscript was published to provide an update of these emerging clinical and research issues in aortic valve therapy (6). Arterial stiffness is a physiologic phenomenon occurring with age and involving changes in extracellular matrix components of the arterial wall. Particularly, the elastin fibres undergo proteolytic degradation and chemical alteration, with consequent increased production of collagen, by vascular smooth muscle cells with progressive arterial wall stiffening (7). Arterial stiffness appears to be accelerated under pathological conditions, such as hypertension, smoking, diabetes mellitus (DM) and kidney disease (8), furthermore has been shown to have two-fold higher incidence in women compared to men (9). TAVI patients have higher median age and comorbidities, directly correlated with arterial stiffness (7), and female gender is a considered high-risk feature for vascular complication independently from SFAR and atherosclerosis (5). Arterial stiffness induces progressive reduction of tensile strength, elongation and burst pressure with consequent drop of vessels breakpoint (10), that could be associated with vascular complications. Particularly, femoral artery stiffness could predispose to microlesions formation at TAVI device access, inducing vascular closure devices failure and vascular complications. Furthermore, vessel rigidity can be associated with a higher resistance during TAVI device delivery and increased probability of vessels injury (especially in presence of tortuosity and small artery diameters). Nowadays, there are no studies evaluating the relationship between arterial stiffness and TAVI vascular complications. The aim of this study is to evaluate the relationship between arterial stiffness and TAVI vascular complications, defining a new predictor of vascular complications in order to give more accurate information for procedures planning.
This is a single group, treatment, Phase 3, open-label, single-arm study to evaluate the efficacy and safety of caplacizumab and immunosuppressive therapy (IST) without firstline therapeutic plasma exchange (TPE) with primary endpoint of remission in male and female participants aged 18 to 80 years with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The anticipated study duration per participant without a recurrence while on therapy is maximum 24 weeks (ie, approximately 1 day for screening + maximum 12 weeks of treatment for the presenting episode + 12 weeks of follow-up). Participants will have daily assessments during hospitalization and weekly visits for assessments during ongoing treatment with caplacizumab and IST. There will be 3 outpatient visits for assessments during the follow-up period. There will be two additional follow-up visits for participants who do not have ADAMTS13 activity levels of ≥50% at the time of caplacizumab discontinuation.
Episodic memory refers to the conscious recalling of a personal experience and includes information of an event and the context in which the event took place. This function is the first to be impaired in Alzheimer's disease, a degenerative condition in which pathological changes are found initially in the medial temporal cortex and then spread in the rest of the cortex starting from post-Rolandic areas. This study aims at examining the mechanisms that enhance memory processes, based on the information acquired by studying hypermnesic subjects. The recent discovery of subjects with an extraordinary ability to remember past events (highly above-average autobiographical memory) and the development of techniques to manipulate memory circuits in rodents provide a unique opportunity to study the mechanisms that determine the facilitation of memories. As part of a multicenter project funded by the Ministry of Health in collaboration with La Sapienza University of Rome, the University of Perugia and the Santa Lucia Rehabilitation Center in Rome, the aspect of the project carried out at CIMeC (University of Trento) will consist in evaluating the changes induced by rTMS in patients with prodromal Alzheimer's disease, after stimulation of the regions that appear particularly active in hypermnesic subjects. This project would offer the possibility of accessing an innovative non-invasive, and non-pharmacological treatment. The specific objectives are: (i) To evaluate the effectiveness of rTMS applied to hyperactive areas in hypermnesic subjects in enhancing autobiographical memories; (ii) Analyzing the neural correlates of the behavioral variations. The study will allow us to define whether it is possible to improve the recollection of autobiographical events by stimulating the circuits that are more active in hypermnesic subjects. The results will be crucial to gain a better understanding of the mechanisms through which brain stimulation contributes to the promotion of neuroplasticity and the effects of rTMS in the prodromal stages of Alzheimer's dementia.
There is currently no information on how mandibular advancement therapy could influence three-dimensionally the condylar and mandibular morphology in growing patients affected by Juvenile Idiopathic Arthritis (JIA). Therefore, the aim is to assess the three-dimensional morphological mandibular changes produced by the Invisalign® Mandibular Advancement (MA) (Align Technology, San José, CA, USA) in growing subjects affected by juvenile idiopathic arthritis with unilateral and bilateral JIA and to compare them with not-JIA control subjects
SPINERY is a Radiofrequency (RF) device designed for palliative treatment of patients with painful metastatic bone tumors involving vertebral bodies, sacrum, iliac crest and peri-acetabulum. In particular, SPINERY is conceived for pain reduction in patients affected by metastatic bone tumors involving the vertebral bodies, sacrum, iliac crest and periacetabulum, in patients with indication for Standard Therapy and in patients who have failed, not candidates or refuse Standard Therapy. Primary objective of the SPARTA Study is to demonstrate that SPINERY RF device is effective in short-term (3 months) pain reduction in patients affected by metastatic bone tumors and to demonstrate that SPINERY RF device is safe in the RF ablation treatment of metastatic bone tumors, without causing device-related adverse events including, in particular, nerve injury. Primary objective hypothesis will be obtained with Brief Pain Inventory (BPI) scale performance questionnaire in terms of palliative treatment. Change of Worst Pain Score expressed as average reduction of 2 BPI (Brief Pain Inventory) scores will be calculated as: μc = worst-pain 3-month - worst-pain baseline A negative average value for change in pain represents a lowering of the subject's pain score (an improvement, or reduction in pain) and a positive value represents an increase in the subject's pain score (a worsening or increase in pain). Worst pain score at the target treatment site will be collected from the BPI in the past 24 hours.
High flow nasal cannula administration in critically ill patients is frequently used to improve acute respiratory failure or to prevent respiratory failure after extubation. It acts generating a mild positive pressure in the airways and by reducing respiratory effort of patients. However to the best of our knowledge, no study to date has directly measured the amount of positive pressure generated in the trachea of patients. The primary aim, therefore, of this study measures this positive pressure after extubation in critically ill patients.
The use of laparoscopy and the ERAS (Enhanced Recovery After Surgery) perioperative pathways are well defined in surgery and widely used worldwide. Predicting the success or failure of ERAS has become a matter of interest, as there is evidence confirming that greater compliance with the items of ERAS improves clinical outcomes. However, the impact that every single item of ERAS programs may have on postoperative recovery remains unknown. Furthermore, the loss of conformity, or deviation from the pathway, is multifactorial and derives from different issues (organizational, cultural, etc.). While data are available on the compliance of surgeons to ERAS pathways, it is impossible to establish which item is related to the benefits induced by ERAS. Regarding abdominal wall reconstruction (AWR) surgery, there is no uniform adherence to the ERAS protocol, often creating confusion about the effectiveness of the protocol itself. The goal of this multicenter, prospective, international, observational study is to prospectively assess adherence to the ERAS protocol in AWR surgery and its effectiveness in patients undergoing elective surgery for ventral primary/incisional hernias. The participating centers will consecutively enroll all patient candidates for an elective ventral or incisional hernia repair (open/laparoscopic/robotic/converted technique). The present study will include all patients ≥18 years old, capable of expressing valid informed consent, with a ventral/incisional hernia diagnosis confirmed by CT/US scan, who will undergo elective surgery. For each patient, anthropometric and personal data (sex, age, BMI) and data relating to their health state (ASA Score, previous abdominal surgery, hernia site) will be collected. Intraoperative data will include the type of surgery and intraoperative complications. Data regarding the adherence/lack of adherence to each item of the ERAS protocol will be collected, and, in the case of non-adherence, the reason will be specified, choosing between "habit", "disagreement", and "lack of organizational pathway", "other". During the post-operative period, all data regarding functional recovery will be recorded, i.e. the day of removal of the drainage, mobilization, return to bowel function, post-operative pain at first and third post-operative day and discharge, and length of hospitalization. Moreover, for each patient, data regarding post-operative complications will be collected and stratified by severity according to the Clavien-Dindo classification. This research is observational; therefore, no interventional changes should be made to the daily clinical practice at each participating center. Patients <18 years old, patients unable to provide valid informed consent, and those who refuse to be included in the study will be excluded. The study's primary objective is to evaluate adherence to the different items of the ERAS protocol for AWR surgery. The study's secondary objective is to evaluate which item of the protocol can affect the post-operative recovery of patients undergoing AWR surgery. The study's primary outcome is the compliance rate for each ERAS item for AWR surgery. The secondary outcomes of the study are the evaluation of complications, length of hospital stay, and recovery time after AWR in relation to compliance with the ERAS items. In addition, the study will evaluate: the time to removal of the drainage tube, if placed (post-operative day, n.), post-operative mobilization (hours, n.), time to resumption of post-operative liquid diet after surgery (hours, n.), time to resumption of liquid diet after surgery (hours, n.), pain at I-II-III post-operative day (VAS Score), time to return to bowel function (gas) (hours, n.), time to return to bowel function (stools) (hours, n.), length of hospital stay (days, n), pain at discharge (VAS Score), post-operative complications (n, within 30 days), type of complication (if any). The complications will be classified according to Clavien-Dindo: Grade I complication according to Clavien-Dindo. Statistical analyses will be performed with the SPSS 27 system (SPSS Inc., Chicago, IL, USA). Continuous data will be expressed as mean ± SD; categorical variables will be expressed as percentages. To compare continuous variables, an independent sample t-test will be implemented. The Wilcoxon Paired-Samples Test will be used as a non-parametric test similar to the paired-samples t-test used for continuous variables. The Chi-square test (or Fisher's exact test where appropriate) will be used to analyze categorical data. The results will be presented as 2-tailed values with statistical significance if p< 0.05. To adjust all other variables and make predictions, multivariate analyses will be performed with operative time or post-operative time or the occurrence of post-operative complications as dependent variables and with significant clinical and demographic characteristics as independent variables.
The purpose of the study is to assess the safety and efficacy of OncoSil™ when given in addition to standard FOLFIRINOX chemotherapy for treatment of Locally Advanced Pancreatic Cancer
The PROTECT-EU Registry is a prospective, non-randomized, multi-national registry to evaluate 90 days outcomes in high risk-PCI (Percutaneous coronary intervention) patients treated with a preventive strategy with Impella CP® System.
This is a Mixed-method study with retrospective quantitative assessment and prospective qualitative evaluation focused on the development and implementation of a multidisciplinary Clinical Ethics Committee (CEC), 16 months from its implementation. A CEC is a multi-professionals service that aims to support healthcare professionals (HPs) and healthcare organizations in dealing with ethical issues of clinical practice, providing also ethics consultations (EC) for complex clinical cases, characterized by conflicting ethical perspectives. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. It was developed and implemented according to the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The purpose of this study is to evaluate the CEC's development and implementation process, after 16 months it entered into force. Study's hypothesis: the investigators expect to identify the relevant components that contribute to the CEC's successful implementation and integration into everyday practice. Findings would also identify required modifications to improve the service and develop practical strategies for enabling and sustaining the CEC delivery in clinical settings.