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NCT ID: NCT04019912 Recruiting - Clinical trials for Interventional Study

The Novel Use of Treadmill Plus Music in MS Patients Gate Rehabilitation

SMUSIC
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Multiple sclerosis (MS) is characterized by demyelination andaxonal loss of the central nervous system, which progressively results in neurologic dysfunction and is often accompanied by gaite limitations, reduced fitness, and increased risk of falls. Traditional exercises such as treadmill walking orstationary cycling can often be perceived as boring, because theseexercises usually involve repetitive, continuous movements. In recents years the positive effect of the auditory stimulus in the recovery of gait difficulties has been demonstrated in Parkinson's disease, however this methodology on MS patients has been poorly investigated. In addiction the neurophysiological mechanisms by which coupling steps with external auditory cues improves gait remain partially unclear. For this reason, our purpose is to investigate whether patients with MS, compared to the control group, may have improvements in motor and psychological well-being, through training with devices that integrate motor training with musical stimuli (Gait trainer).

NCT ID: NCT04019678 Recruiting - Breast Cancer Clinical Trials

Breast Cancer: Axillary Conservation After Neoadjuvant Chemotherapy in Micro Metastatic Sentinel Lymph Nodes.

NEONOD2
Start date: June 21, 2019
Phase: N/A
Study type: Interventional

Italian multicentric non inferiority clinical study to verify whether the omission of axillary lymph node intervention in patients with SLN (Sentinel Lymph Nodes) ypN1mi after NAC (Neo Adiuvant Chemotherapy) does not lead to a significant deterioration in survival or in the risk of regional or distant recurrence, compared to patients with negative SLN (SLN ypN0) after NAC ,where the omission of axillary treatment is currently the standard treatment.

NCT ID: NCT04017780 Recruiting - Clinical trials for Pediatric Respiratory Diseases

Asynchronies in Pediatric Noninvasive Ventilation

Asyn-Vent
Start date: September 15, 2019
Phase: N/A
Study type: Interventional

The term ''Non-invasive ventilation'' (NIV) refers to various methods of respiratory assistance, in the absence of an indwelling endotracheal tube. In recent years, the use of NIV has increased for the treatment of both acute and chronic pediatric respiratory failure. Patient tolerance to the technique is a critical factor determining its success in avoiding endotracheal intubation. One of the key factors determining tolerance to NIV is optimal synchrony between the patient's spontaneous breathing activity and the ventilator's set parameters, known as ''patient-ventilator interaction''. Indeed, synchronization of the ventilator breath with the patient's inspiratory effort, optimizes comfort, minimizes work of breathing and reduces the need for sedation. During NIV, several factors can significantly interfere with the function of the ventilator, leading to an increased risk of asynchrony. Indeed, the presence of unintentional leaks at the patient-mask interface, the sensitivity of inspiratory and expiratory triggers, the ability to compensate for intentional and unintentional leaks and the presence/absence of expiratory valves are all factors that likely play a role in determining patient-ventilator synchronization. The investigators therefore designed the present crossover trial in order to compare the degree of respiratory asynchronies during NIV using different ventilators (Turbine-driven ventilator vs. compressed air-driven ICU ventilators) and different setups (single circuit vs. double circuit) in children with acute respiratory failure.

NCT ID: NCT04016545 Recruiting - Clinical trials for Peri-operative Mortality

Mortality and Complications in Endovascular Procedures Performed With New Generation Low-profile Devices

Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to observe mortality and complications in procedures in which are used new generation low-profile endoprothesis.

NCT ID: NCT04014907 Recruiting - Clinical trials for Peri-operative Mortality

Open Repair Versus Branched Endograft Repair for Treatment of Residual Chronic Aortic Arch Dissection During Follow-up After Open Type A Acute Ascending Aorta Replacement: Results From an International Multicenter Study.

Start date: August 1, 2019
Phase:
Study type: Observational [Patient Registry]

This study aims to evaluate peri-operative mortality and main post-operative complications (for example cardiovascular, respiratory and renal) in patients treated with frozen elephant trunk techinque.

NCT ID: NCT04013022 Recruiting - Clinical trials for Cardiovascular Risk Factor

Exercise Pressor Reflex and Lifelong Training

LEaSTCaRe
Start date: August 1, 2019
Phase:
Study type: Observational

Cardiovascular diseases represent the first mortality cause in the world. Ageing is considered as the most prominent risk factor for this kind of diseases. Also, hypertension represents one of the modifiable risk factors. Blood pressure response to exercise is governed by three systems: central command, baroreflex, and a feedback mechanism originating in the skeletal muscle. An abnormal cardiovascular response to exercise facilitates the occurrence of cardiovascular events. The goal of the study is to characterize the cardiovascular response in lifelong trained individuals and explore the potential benefits of endurance and strength training on cardiovascular regulation to exercise onset.

NCT ID: NCT04012242 Recruiting - Ultrasound Clinical Trials

Innovative Liver Elasticity, Attenuation, and Dispersion Ultrasound Study

iLEAD
Start date: June 15, 2019
Phase:
Study type: Observational

The objective of this study is: (1) to investigate the correlation of ultrasound parameters (SW speed, Dispersion slope, Attenuation value, Normalized Local Variance, Liver / Kidney Intensity Ratio) with the pathological parameters (fibrosis, intralobular inflammation, ballooning degeneration and steatosis); (2) to evaluate the diagnostic performance of SW speed for liver fibrosis, Dispersion slope for intralobular inflammation and Attenuation value for steatosis by comparison with the tissue diagnosis by liver biopsy.

NCT ID: NCT04012073 Recruiting - Clinical trials for Respiratory Distress Syndrome, Adult

Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute Respiratory Distress Syndrome

IPERPEEP
Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

During the acute respiratory distress syndrome (ARDS), patients' response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a tool to individualize PEEP on the basis of patients' individual response is warranted. Measurement of end-expiratory lung volume (EELV) by the nitrogen washin-washout technique, bedside available from recent ICU ventilators, has been shown to reliably estimate PEEP-induced alveolar recruitment and may therefore help titrate PEEP on patient's individual requirements. The authors designed an open-label, multicenter, randomized trial to test whether an individualized PEEP setting protocol driven by EELV may improve a composite clinical outcome in patients with moderate-to-severe ARDS.

NCT ID: NCT04012021 Recruiting - Pancreatic Cancer Clinical Trials

EXplanted LIver and Ex-vivo Pancreatic Specimen Evaluation by 7 TESLA MRI

EXLIPSE
Start date: May 24, 2019
Phase: N/A
Study type: Interventional

Aim of this study is to evaluate the correlation between the characteristics detected by the 7T MRI equipment and the histological composition of native explanted livers (group A), liver graft excluded for donation (group B) and surgical specimens of primary pancreatic tumour, which underwent pancreaticoduodenectomy (group C).

NCT ID: NCT04009746 Recruiting - Biliary Condition Clinical Trials

Italian Registry of ERCP With Spyglass

Spyglass
Start date: January 21, 2016
Phase:
Study type: Observational

Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used for the diagnosis and treatment of diseases of the biliary tract, pancreas and papilla of Vater. The ERCP allows an indirect vision of the ductal and pancreatic system by means of the endoductal injection of contrast medium and the evaluation of these by X-rays. Recently, cholangioscopy has been developed using the Spy Glass system, introduced on the market in 2007. This allows a direct visualization of the bile duct and pancreatic pathway through the introduction of an optical probe inside the ductal system. SpyGlass was developed to overcome the limitations of traditional cholangioscopy and allow optically guided therapies for the treatment of stenoses and calculations. This is the first cholangioscopy system performed by a single disposable operator (SOC), with two dedicated irrigation channels, an optical channel and a therapeutic channel with a diameter of 1.2 mm. Everything is placed inside a 10 Fr Spy Scope ™ access and delivery catheter (3.3 mm), which allows the tip to flex in 4 directions to facilitate maneuverability and directionality in small ducts. The irrigation channels of the SOC system allow a fluid flow rate of four to five times higher than that which can be obtained through the operating channel of conventional systems. In bench simulations with loaded Spy Bite ™ biopsy forceps, the SOC system presented a success rate in obtaining access to sites of double interest compared to that of a conventional 2-way limited bending choledocoscope. Some studies have confirmed the adequacy of the Spy Glass system in providing adequate samples for histological diagnosis and successfully facilitating the treatment of stones. The new single-use Spy Glass digital display system was introduced in 2014 and no multi-center experience on the use of this device is described to date.