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.
Migraine may have an adverse effect on physical, cognitive, and psychosocial functioning. It causes major consequences for the quality of life of the sufferer and a major burden on the health care system. About the physiopathology, two opposing processes, depression (habituation) and facilitation (sensitization), determine the final behavioural outcome after a sequence of repetitive stimuli. Sensitization is a general behavioural response of augmentation to innocuous sensory and noxious stimuli. It has been associated with a dysfunction in descending pain inhibition. The nature or intensity of a painful event does not strongly relate to the development of chronic pain, but an individual's behavioural response to the event contributes to chronicity. Imaging data have identified that chronic pain may change the structure of the brain in response to environmental demands. It suggests that the brain of healthy control has a "healthy response" to frequent nociceptive input, such as "habituation", while chronic pain patients show a "maladaptive plasticity". Habituation is "a response decrement as a result of repeated stimulation". It is a phenomenon observed in the autonomic and behavioural component called the "orienting response" in humans. The orienting response is elicited when a novel stimulus is encountered, and it directs attention toward that stimulus. When the same stimulus is presented repeatedly occur habituation. Researchers have found a number of physiological mechanisms associated with Orienting response. Habituation of the orienting response is a simple form of learning and acts an attentional filtering mechanism that makes people able to select what is part of their present goal and adapt to environment. In this way only one channel of information to be processed, with the rest filtered out. Habituation depends on a memory process whereby the organism learns to associate goal irrelevant stimuli with a no-consequence response. Lack of Habituation during stimulus repetition is a functional property of the brain in people with migraine between attacks. Thalamo-cortical dysrhythmia and lack of H characterize migraineurs' brains. This abnormal information processing increases during the pain-free days, the vertex is just before the attack, and decreases in the ictal phase. Migraineurs are characterized by a generally increased sensitivity to visual (sensitivity to light), auditory (to sound), or somatic stimuli not only during the attack, but also outside of the attack. It was confirmed also by analysing motor cortex excitability. Aerobic exercises may be effective as pharmacological treatment in the management of migraine and focused attention task may help human subjects to better ignore irrelevant stimuli. The main aim of this study is to assess the efficacy of a non-pharmacological treatment, such as physical therapy, with a specific dual task protocol of active exercise with concomitant cognitive tasks, in relation to habituation (Transcranial magnetic stimulation) and sensitization (Algometer assessment) neurophysiological outcomes. The second aim is to assess these non-pharmacological treatments concerning to clinical outcomes (intensity of pain, duration of attacks and frequency of pain; neurophysiological test on executive functions).
The purpose of the study is to conduct a prospective evaluation of the diagnostic performance of the IVD CAPSULE COVID-19-NP test for antigenic determination of SARS-CoV-2 virus on the abioSCOPE® instrument. The objective of the clinical study is to demonstrate that the IVD CAPSULE COVID-19-NP test: 1. shows sensitivity: - ≥ 80% when testing unselected symptomatic participants within the first seven days of symptom onset or asymptomatic participants when diagnosis is confirmed by RT-PCR; Or - ≥ 90% for subjects with Ct ≤ 25. 2. show ≥ 98% specificity.
Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective self-care. Motivational interviewing (MI) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF. Methods and analysis: This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled MI interventions in improving self-care behaviors among patients with HF at 3, 6, 9, and 12 months from the enrolment. Secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. Analyses will be performed within the framework of intention-to-treat (ITT). Comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods. Ethics and dissemination: The study protocol and template consent forms have been reviewed and approved by the Ethical Committee of San Raffaele Hospital (approval #74/INT). Also, the study protocol has been registered at ClinicalTrials.gov (Identifier: …….). Patients and caregivers will have to sign the informed consent forms before the randomisation. Patients and caregivers may leave the study at any time. The withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. Considering the open-access publication, the full protocol will be available freely.
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.
Although CRE infection after OLT have a dramatic impact on patient survival and several implementations have been proposed (i.e. preventive strategies or targeted surgical prophylaxis), a standardized approach in colonized patients is still missing. The investigators recently developed and internally validated a bed-side score to stratify the risk of CRE infection in OLT recipients colonized by CRE. The goal of this pre/post observational study is to investigate the impact on all-cause 90-day mortality in OLT recipients colonized with CRE using such score (CRECOOLT score) for the systematic evaluation of CRE infection risk. The secondary objectives are: - To analyse days of therapy with anti-CRE antibiotic regimens in patients with and without systematic evaluation of CRE infection risk, according to clinical practices. - To evaluate rates of documented CRE infections and their relapses with selection of further resistance in patients with and without systematic evaluation of CRE infection risk. - To evaluate the length of hospital, ICU stay and rates of hospital readmission in patients with and without systematic evaluation of CRE infection risk.
multicentre randomized controlled prospective study aimed at evaluating the efficacy of the infiltration of microfractured adipose tissue in the healing of perianal fistulas not-responding to treatment with biologics, in order to improve the quality of life and significantly reduce the risk of definitive ostomy.
Eosinophilic esophagitis (EoE) is a chronic, immune-mediated, esophageal-restricted disease characterized clinically by symptoms related to esophageal dysfunction and histologically by an eosinophil-predominant inflammation.A dramatic increase in incidence and prevalence of EoE has been documented over the last 2 decades, especially in Western countries.EoE is currently the most common cause of dysphagia and bolus impaction, and the second leading cause of chronic esophagitis after gastroesophageal reflux disease.Predominant symptoms of EoE in adult patients are chronic dysphagia, food impaction, and chest pain.EoE is a chronic-progressive disease and, if left untreated, is usually associated with persistence of symptoms and inflammation.Furthermore, it is well established that the ongoing eosinophilic inflammation leads to esophageal remodeling, resulting in fibrosis with possible stricture formation and functional damage.Consequently, EoE has a substantial negative impact on the health-related quality of life (HRQoL) of patients and their families by causing emotional distress and restricting social activities.There is, therefore, a clear indication to treat patients suffering from active EoE. Today, swallowed topical-acting corticosteroids (STCs) are an established first-line pharmacologic treatment for patients with EoE.Proton pump inhibitors (PPIs) and dietary modifications are alternatives. From the first positive attempt to treat EoE with STCs, drugs that were originally developed for airway administration in patients with asthma and used off-label in eosinophilic esophagitis,multiple trials have confirmed the efficacy of these compounds in improving symptoms as well as inflammation in patients with EoE. Fluticasone or budesonide have shown comparable potencies, but the vehicle depositing the compound on the esophageal surface seems to be critical.Until now there has been no licensed therapy for eosinophilic esophagitis treatment; treatment using drugs adapted from other conditions has been limited and not standardized. Recently a new budesonide orodispersible tablet formulation (BOT, originally defined as an "effervescent tablet for orodispersible use [BET]") has been created and has been shown in clinical trials to be able to resolve both the symptoms and the underlying inflammation in EoE in most patients. Budesonide orodispersible tablet treatment has been shown to be significantly more effective than placebo in inducing clinical and histologic remission in patients affected by EoE. A phase 3 trial showed the effectiveness of a 6-week treatment with new budesonide orodispersible tablet (BOT) to induce clinicohistologic remission in 58% of adult patients with EoE, which increased to 85% when therapy was extended to 12 weeks in nonresponders. Another clinical trial showed that after 48 weeks of treatment, 73.5% of patients treated with low-dose and 75% of patients treated with high dose budesonide remained in remission, compared with 4.4% of patients treated with placebo. The budesonide orodispersible tablet formulation, with the name of Jorveza, received the marketing authorization valid in the EU on 8 January 2018 and recently received AIFA approval to be distributed in Italy as the first medicine with indication for eosinophilic esophagitis. Therefore, patients with eosinophilic esophagitis who are taking off-label corticosteroid formulations (fluticasone diproprionate and budesonide in galenic formulation) will need to make a therapeutic transition to Jorveza. No data are currently available in the literature about efficacy, safety and patient' satisfaction after therapeutic switch from off-label swallowed topical-acting corticosteroids to budesonide orodispersible tablet formulation (Jorveza).
The primary aim of the study is the evaluation of the efficacy of remote ischemic preconditioning (RIPC) in terms of increase of the clearance of lactates 4 hours after the end of the hepatic resection. The secondary aims of the study are represented by the evaluation of the patients' postoperative recovery and the restoration of a normal lactate metabolism.
This is a window-of-opportunity study for patients with resectable Merkel Cell Carcinoma. The aim of this study is to test the activity of a course of chemo-immunotherapy followed by surgery in patients with operable Merkel cell carcinoma. Participants will receive one cycle of retifanlimab plus platinum-etoposide chemotherapy prior to their scheduled surgery.
Frailty has been recently re-defined as a condition that is evident over time through an excess of vulnerability to stressors, with reduced ability to maintain or regain homeostasis after a destabilizing event, and occurrence of disability. Frailty has been often used to characterize the weakest and most vulnerable subset of older adults, because of age, comorbidities, social and emotional status leading to the lack of functional and psychological reserve and mining the capability to face acute events. Frail patients are becoming ever more present in Anesthesia and Intensive Care. In fact, 30 percent of surgery is conducted on patients ≥ 70 years old nowadays. It has been demonstrated that the impact of surgery and anesthesiologic risk are greater in older frail subjects, and that a low functional status is associated with increased mortality. Also, post-operative delirium and cognitive disfunction are more often seen in older patients. For this reason, the worsening of the global performance status, as functional status, mobility, and cognitive status may have a large impact on patient and caregivers' life. The primary objective is to evaluate the impact at three months after hospitalization following major surgery i.e., urology, general surgery, orthopedics, on the performance status as functional status, mobility, and cognitive status of patients ≥ 70 years old. Secondary objectives are to evaluate the necessity of domiciliary care assistance and re-hospitalization or rehabilitation center admissions in three months following surgery and to evaluate the impact of the type of anesthesia used in major surgery i.e., general vs regional anesthesia, on patient performance status.