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.
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of tocilizumab (TCZ) compared with a matching placebo in combination with standard of care (SOC) in hospitalized patients with severe COVID-19 pneumonia.
This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.
Hypothesis Very recent evidences supports the hypothesis that the novel coronavirus 2019 (2019-nCoV) uses the SARS-1 (severe acute respiratory syndrome ) coronavirus receptor angiotensin converting enzyme 2 (ACE2) for entry into target cells. The epidemiological association between Angiotensin receptor-blocker (ARB) or ACE inhibitors (ACE-I) use and severe sequelae of 2109-nCoV infection disease COVID-19 has not been yet conclusively demonstrated, but may have important consequences for population health. Aim To retrospectively test whether 2019-nCoV patients treated with ACE-I or ARB, in comparison with patients who not, are at higher risk of having severe COVID-19 (including death). Population Hospitalized patients with confirmed COVID-19 infection (any type). Study design Patients will be divided in two groups, a) controls: individuals who did not develop severe COVID-19 respiratory disease (including individuals who recovered from the infection) and b) cases: individuals who developed severe COVID-19 disease (including fatal events). Treatment with ACE-I or ARB, together with possible confounding will be assessed retrospectively. Exposure Treatment for ACE-I or ARB.
The study was aimed at comparing four different anthropometric parameters to cardiometabolic risk factors in overweight and obese subjects (Body Mass Index (BMI)≥25)
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting. This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.
The TENAR trial is the first randomized controlled trial (RCT) designed to evaluate the feasibility, efficacy, safety, and costs of a Telemedicine multidisciplinary approach for the management of narcolepsy. Open RCT assessing the non-inferiority of the multidisciplinary management of narcolepsy via Video Consultation (VC) through Mobile Telemedicine devices compared to usual in-office care. 202 children and adults with narcolepsy will be randomly allocated in 1:1 ratio to VC or in-office usual care for a 12 months follow-up. At baseline, all patients will undergo a neurologic, metabolic, and psychosocial assessment. Primary (i.e., excessive daytime sleepiness according to the Epworth Sleepiness Scale) and secondary endpoints (i.e., other symptoms, metabolic control, quality of life, patient and family satisfaction with care, feasibility, safety, and costs) will be measured at 6 and 12 months. The investigators expect the Telemedicine approach not only to be non-inferior for sleepiness control but also to significantly improve other patient-centred outcomes compared to the usual in-office care.
Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. The main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. The comparison between the measurements of breathing frequency obtained by using the IMU-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. Participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. Moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function
This trial will be conducted to demonstrate the efficacy and safety of vadadustat compared to darbepoetin alfa for the maintenance treatment of anemia in hemodialysis participants after conversion from current erythropoiesis-stimulating agent (ESA) therapy.
As part of the EMPATIA @ Lecco project, task 2.9 and task 4.5 respectively provide for the refinement and testing of robotic solutions on the market oriented towards patient empowerment. Within the LARA project, the JACO2 mechanical arm (Kinova Technology, Montreal, QC, Canada), a medical device, which can perform some functions as if it were the subject's arm, will be tested. JACO2 can be controlled by joystick, supplied with the system, or by voice control system, developed by CNR-ITIA to allow use even for those with severe strength impairments. The trial will involve patients with Duchenne Muscular Dystrophy (DMD), Becker Muscular Dystrophy (BMD), Limb Girdle Muscular Dystrophy (LGMD), congenital and Facioscapulohumeral Muscular Dystrophy (FSH) over the age of 10 years. In literature of the last decade we find evidence of social and personal benefits deriving from the use of assistive mechanical arms in daily life activities by patients with disabilities due to neuromuscular diseases. The results indicate improved quality of life, greater self-esteem and greater integration into society. In addition to the benefits for the person, it has been shown that the introduction of assistive technologies in the life of patients can lead to potential savings on direct and indirect costs of National Health Services. Assistive robotic arms have a potential user base of approximately 150,000 people only in the United States of America. This population includes subjects who have partially lost the function of the upper limb due to degenerative diseases or because of spinal cord injuries or infantile cerebral palsy. The number of potential users could increase by improving the usability of these systems that, at the moment, still require a certain functionality of the upper limb, in general, and of the hand, in particular. It is in fact known that the introduction of assistive technologies in daily life is not limited so much by the fact that patients do not accept or profit from them, but rather by the actual possibility of using them effectively. Therefore, a customization of the functionality of the devices based on needs and wishes of the patients alongside an improvement in their usability would lead to an increase in potential users. It is for this reason that usability, together with safety, has become one of the most studied topics in assistive robotics. In the case of assistive robotic manipulators, usability problems often concern their control which, even today, takes place through the use of joysticks that require fine motor skills in the hand. In fact, being systems with multiple degrees of freedom, that is, equipped with different segments that can translate (or rotate) in different directions, different buttons are integrated in the control joysticks in addition to the classic lever with knob. From this emerges the need to develop alternative joystick control methods that do not involve the use of the hand.
The European VALHUDES study is a Clinical Performance /Diagnostic Test Accuracy Study that aims to evaluate whether HPV testing with new assays performed on self-samples, collected by means of a vaginal and a urine collection device is as accurate to detect cervical pre-cancer as on cliniciantaken cervical samples.