There are about 20955 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 Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the gastrointestinal tract including Crohn's disease and Ulcerative Colitis. The course of IBD is frequently progressive and can be hardly predictable, with sudden exacerbations of intestinal symptoms. Epidemiological studies have shown that IBD has an increasing prevalence to reach 10 million people in 2030. These diseases require frequent interactions between patients and the healthcare system, or symptom management with continuous therapies, gastroenterological visits, surgery, contacts for resolution of urgent symptoms from telephone and email, access to the emergency, hospitalizations, nutritional counseling, psychological interventions and follow-up controls. An IBD can completely disrupt a family's ability to function normally and often imposes a strain on family members' relationships. In the model of self-care in chronic diseases, according to Riegel's "Middle Range Theory", there are external factors, predictive factors that can influence and limit the patient's attitude and therefore his self-esteem, the ability to implement decision-making behaviors to improve and increase his self-care. There are also factors that influence a person's self-care decisions: the particular caregivers. In this process, the role of the caregiver and the dyad he establishes with the patient can influence the whole process of self-confidence and self-care. The objectives of the study are to investigate and describe self-care in patients with IBD and how their caregivers in dyadic interaction can contribute.
Mutations in the CAPN3 gene cause muscular dystrophies with dysfunction in calpain-3. Calpainopathies are usually inherited in an autosomal recessive manner but in some families they can occur in a dominant inheritance. The significance of heterozygous variants is difficult to interpret in the absence of family history. In this study, the investigators will review the clinical and laboratory information in a cohort of patients identified in the participating centers, with the aim of improving the diagnostic strategy of dominant calpainopathies.
The aim of this open-label, randomized, 3-parallel arm trial is to compare success of intubation rate at first try between three groups that will be intubated: 1. Conventional intubation with hyperangulated videolaryngoscope (control group), 2. Intubation ProVu TM video stylet combined with hyperangulated videolaryngoscope, 3. Intubation ProVu TM video stylet combined with standard Macintosh laryngoscope.
Major depressive disorder (MDD), is a major medical and economic burden for today's society. About 30% of MDD patients develop treatment-resistant depression - TRD with the related sequelae in terms of worse prognosis. If several risk factors can be assessed readily on presentation, it can guide treatment planning and ultimately improve clinical outcomes. Currently, unlike other areas of medicine, poly-risk tools to facilitate this stratification in practice among patients with MDD are lacking but demanded in the era of personalised/precision medicine - a challenge that the project takes up. Ketamine - a glutamate N-methyl-d-aspartate (NMDA) receptor antagonist, is the first exemplary agent with rapid (within hours) antidepressant effects, even in TRD patients.Its mechanisms of actions (MoA) are still unclear but greatly demanded. So far, insights about ketamine's MoA come from preclinical animal studies but it's known that animal models have limited ability/effectiveness in mimicking the clinical complexity and were not subjected to sequential application of different treatments - a key requisite in humans to be defined as TRD. This ambitious inter/multidisciplinary project, has 3 goals: 1. To develop a clinical risk stratification tool for predicting TRD development. 2. To unravel ketamine's fast-acting antidepressant mechanisms of action (MoA) on mature neurons obtained from human induced pluripotent stem cells (iPSCs) obtained from (ketamine-responsive & non-responsive) patients with TRD. 3. To give maximum visibility to the project and spreading its contents & findings to and in a way understood by all target groups variously implicated/interested in project research & innovation.
Approximately 55,000 cases of breast cancer are diagnosed in Italy every year and the first-line therapy for carcinoma in situ, stage I, II and IIIA is surgical removal of the tumour. The incidence of chronic pain after breast cancer surgery is confirmed around 30%. This study aims to evaluate the impact of loco-regional anesthesia techniques in the context of multimodal analgesia in the prevention of chronic pain post-oncological breast surgery
LUCENT is an observational study focused on malignant pulmonary and tracheo-bronchial disease. It involves a large proportion of reference Italian thoracic surgery centers. The relevance of the study is related to the epidemiology of lung cancer in the world - also known as "Big Killer" - and the high mortality rates both in males and females. The aim of his prospective study is to collect a large bulk of postoperative patients' outcome data and to produce up-to-date descriptive statistics of patients undergoing surgery for lung cancer. These results will be pivotal to compare the clinical results of all the relevant specialities involved in the care of lung cancer such as medical oncologists and radiation oncologists.
AIM OF THE STUDY The aim of the study is to develop a Resectability Laparoscopic Score as a helpful instrument during intraoperative decision-making in the setting of emergency laparoscopic surgery for small bowel obstruction (SBO) by analyzing a multicenter data registry. DESIGN OF THE STUDY This is a multicenter study composed of a first phase of prospective data collection from patients that undergo laparoscopic surgery with a diagnosis of SBO and undergo Indocyanine green (ICG) fluorescence angiography (FA) for doubts about bowel viability after the resolution of the obstructive mechanism; the second phase of retrospective analysis to develop the Resectability Score. METHODS The FA should be performed in all patients undergoing laparoscopic surgery for SBO that presents concerns bowel viability after the resolution of the occlusive mechanism, with consequent intraoperative enrolment in the study Registry. The investigators adopted the modified Bulkley classification of the fluorescent patterns to identify which patients need more FA to assess bowel vitality. It is expected that most patients for whom the FA will be performed are those with patterns 2 or 3, representing the study's primary object. All participant centers must adopt the same technique to perform FA with the attempt to homogenize the procedure. Twenty-five milligrams of ICG powder is suspended in 10 ml of sterile water and administered intravenously through a peripheral vein and in small repeatable boluses of 2 ml in order to evaluate the intestinal microcirculation extemporaneously. The presence and pattern of arterial supply is tested and compared with that of healthy bowel. Proper clearance of the dye was also appraised to verify adequate venous drainage. Following the reversal of the underlying cause of the ischaemic injury, and after generous irrigation with warm saline, the involved bowel segment was further evaluated with FA after 10 min, regardless of the return of visible peristalsis. Routine postoperative clinical judgment will be considered sufficient to check bowel vitality. The need for a second-look surgery and delayed resections will be recorded. All centers could participate with a maximum of 3-4 members (co-authorship) Data will be recorded by a simple and brief online Case Report Form (CRF) on which upload also a photo/brief video of the FA, will be filled out by every participating center for each patient. A link to a Google Form and the necessary documents will be sent to every center after they have accepted to participate in the study.
The goal of this prospective pilot study is to test the use of dynamic elastomeric body in a population of preterm newborns with hyperexcitability syndrome. The main questions it aims to answer are: - To evaluate the effectiveness of the body in elasto-compressive material (FLEXA) in addition to standard care; - To evaluate how the use of dynamic elastomeric body promote postural containment, reduce hyperexcitability (tremor and crying), improve the organization of movement and reduce respiratory distress. Participants will be given to routine clinical evaluations that are part of the standard of care of the premature infant admitted to Neonatology. The clinical evaluation shall consist of: - Hammersmith neonatal neurological examination; - Neonatal Intensive Care Unit Network Neurobehavioural Scale (NNNS); - General Movement's (GM's) - Goal Attainment Scaling (GAS) Researchers will compare a study group that will be subjected to treatment with the body in elasto-compressive material and a control group without using the body in elasto-compressive material.
The present study grounds on the absence of evidence-based treatment in individuals with developmental dyslexia (DD). At this topic, the present study will explore the potential effect of transcranial random noise stimulation (tRNS) and transcranial direct current stimulation (tDCS) over bilateral temporo-parietal cortex (TPC), cerebral areas usually disrupted in individuals with DD. The investigators hypothesized that active tRNS and tDCS over TPC will boost reading skills in children and adolescents with DD. On the contrary, sham (placebo) tRNS and tDCS over TPC will not have significant effect in improving reading skills. Further, both active and sham tRNS and tDCS will be safe and well tolerated.
Tricuspid regurgitation (TR) is a public health problem: moderate / severe TR are common, especially in ageing populations, and affect 4% of the population >75 years old, totaling approximately 1.6 million in the US and 3 million in Europe. TR is associated with an increased risk of mortality and morbidity. Contrasting with TR prevalence and the magnitude of the problem, the vast majority of patients are medically treated with diuretics to relieve their symptoms and a curative surgical treatment for isolated severe TR is seldom performed. Reluctance to perform an ITVS can be explained in the one hand by the limited evidence that TR correction improves outcomes and on the other hand, ITVS is associated to high observed in-hospital mortality rates (≈ 10% remarkably consistent in most series across the literature). Severity of the clinical presentation is the main predictor of outcome after surgery. The TRI-SCORE, is a dedicated, simple and accurate risk score model to predict in-hospital mortality after ITVS that could guide the clinical decision-making process at the individual level. Excellent outcomes can be achieved when patients present with low TRI-SCORE. These results suggest adopting a more pro-active approach for TV interventions, and to intervene earlier in the course of the disease in patients with severe isolated TR, irrespective of TR mechanism / etiology, before the occurrence of advanced / irreversible consequences such as severe RV dilatation / dysfunction, renal and liver failure, and intractable heart failure. Recently transcatheter tricuspid valve interventions (TTVI) have emerged recently as a less invasive option to surgery to cure patients with TR. What is the best treatment between medical, surgical or transcatheter therapy to consider and the best timing for each patient are not clearly defined. The aim of the study is to compare outcome of patients with significant functional TR according to medical, transcatheter or surgical treatment after matching per TRISCORE.