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.
Neurologic Music Therapy (NMT) sensorimotor techniques are increasingly used to improve spatio-temporal gait parameters and postural stability in the course of Parkinson's Disease and following stroke. Nonetheless, the neurophysiological underpinnings of NMT-mediated gait recovery is still poorly understood. The aim of the study was to investigate the central mechanisms of connectivity related to the application of Rhythmic Auditory Stimulation (RAS) in PD gait rehabilitation. The investigators will enroll 30 patients with PD. They will be randomized into two groups: (A) gait training with Music; (B) conventional treadmill gait training. The experimental group will perform training by means of GT3 (Biodex), where the patient is able to walk (on a treadmill) following specific musical beets and rhythms. The control group will perform only gait treadmill training. Subjects will attend 3 sessions a week for at least 4 weeks. Each session will last 45-min.
This study will evaluate the efficacy and safety of atezolizumab in combination with bevacizumab compared with sorafenib in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have received no prior systemic treatment.
Aortic aneurysms represent the most common and dangerous aortic diseases. Although conventional aortic repair techniques cure the disease, there is a high risk of paraplegia particularly in extensive thoracoabdominal aneurysms due to impaired blood supply to the spinal cord. The PAPA-ARTiS trial will assess the clinical safety and efficacy of the MISACE (Minimally-Invasive Segmental Artery Coil-Embolization) procedure, a novel therapeutic concept to reduce the risk of paraplegia due to aneurysm repair. The study investigates the MISACE procedure as a potential pre-treatment prior to open or endovascular aneurysm repair in patients with thoracoabdominal aortic aneurysms. Patients will be randomized to one of the two treatment strategies: a) aneurysm repair without MISACE pre-treatment, or b) aneurysm repair with MISACE pre-treatment.
This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
This prospective randomized study is designed to provide high level of evidence supporting superiority of robot assisted (RA) versus open (O) radical cystectomy (RC). The primary endpoint is a 50% reduction of transfusion rate, several perioperative outcomes potentially linked to a reduced invasiveness are considered as secondary endpoints. Investigators hypothesis is that the reduced invasiveness of RARC might turn into a higher adherence to enhanced recovery after surgery (ERAS) protocols (early bowel recovery, reduced need for painkillers and insertion of nasogastric tube) and consequently to shorter hospital stay and to faster return to daily activities. These data will be taken into account in a matched cost analysis between arms. Secondary aims include a between arm matched comparison of perioperative complications, oncologic outcomes (2-yr disease free survival is an accepted surrogate of long term oncologic effectiveness of RC) and functional outcomes (daytime and nighttime continence).
This is an italian multicenter study to determine whether maintenance treatment with Lenalidomide-based regimen significantly increases the rate of molecular remission in patients achieving at least a VGPR after therapy with new drugs combination. No changing in the planned therapy will be made according to MRD results. A total of 70 patients with newly diagnosed MM who are 18 years of age or older and who meet all of the eligibility criteria may be enrolled in this study. Potential study subjects will sign an informed consent prior undergoing any study related procedure. Patients enrolled in this study will receive Lenalidomide-based regimen as maintenance therapy according to their previous decided therapeutic schedule. All consecutive patients treated with Lenalidomide-based regimen as maintenance therapy and with inclusion criteria will be asked to participate to this study. No additional drugs will be administrated for this study whose aim is to monitor the MRD on bone marrow aspirate and peripheral blood of patients during maintenance therapy with Lenalidomide-based regimen.
The main purpose of this study is to evaulate the efficacy and safety of galcanezumab in participants 6 to 17 years of age for the preventive treatment of episodic migraine. The primary objective is to demonstrate the superiority of galcanezumab versus placebo in the reduction of monthly migraine headache days across the 3-month double-blind treatment period.
The objective of this human randomized, double blind, placebo-control (RDBPC) study is to evaluate the efficacy of a 0.2% chlorhexidine (CHX) gel on reducing bacterial load and peri-implant inflammation at implant-abutment interface during the early healing stage.Thirty-six healthy patients (mean age 52,28 years; range 29-75 years) without a significant past medical anamnesis, all non-smokers, will be recruited as candidates for single implant placement and prosthetic rehabilitation.Patients will be randomly divided in group A (control) and group B (test) as indicated by the randomization chart. All Implants (Cortex classic, Shalomi, Israel)would be inserted by two skilled operators who followed a two-stage protocol and placed them according to the manufacturer's instructions.Eventually, all patients will be rehabilitated with a single implant-supported crown. During all the stages either a gel containing 0.20% CHX (Plak ®Gel; Polifarma Wellness Srl, Rome, Italy) or a placebo gel (Placebo, Polifarma Wellness Srl, Rome, Italy) will be used. The two gels are perfectly alike in packaging, color and smell and nobody knew the exact location of placebo or test gel, which will be revealed, only after data collection would be performed, by the person who prepared them. A or B gel will be placed on the internal connection abutments and then a cover screw would be inserted. Finally, the site would be sutured with non-absorbable nylon sutures. Cone Beam Computed Tomography evaluation (CBCT) (VatechIpax 3D PCH-6500, Fort Lee, NJ USA) would be performed both for pre-operative and post-surgical implant placement. Both gels will be given to the patients, according to the protocol, and applied 2 times/day until suture removal after 7 days. Soft tissue biopsies would be performed by means of a circular scalpel (5.5 mm in diameter) at the implant insertion (T0) and after two months of healing (second stage surgery)(T1) to analyze the peri-implant inflammatory infiltrate and the micro-vessel density (MVD) in both groups. All the radiographs taken during the study time points would be analysed to measure the bone resorption after 1 year or on other studt time points.
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.