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 pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in laparoscopic and robotic hernia surgery to obtain the indication and upgrade the medical device Glubran® Tiss 2 to class IIb.Cyanoacrylate is the generic name of a group of fast-acting adhesives such as ethyl-2-cyanoacrylate, n-butyl cyanoacrylate, 2-octy1 cyanoacrylate sold under various trade names and blend. Cyanoacrylate is a liquid acrylate monomer that polymerizes exothermically in the presence of water, especially with hydroxide ions, joining the bonded surfaces in 4-5 s and reaching the final stage in 60-90 s . It bonds body tissue excellently and shows bacteriostatic effects . The film of glue is eliminated by hydrolytic breakdown, a process whose duration varies according to tissue type and quantity . In contrast to most cyanoacrylate glues used only for external applications as skin wound closure, Glubran® 2 is a modified n-butyl-cyanoacrylate (Glubran® 2 - N-Butyl 2 Cyanoaciylate [NBCA]+ Methacryloxysulfolane [MS]), class III medical device, CE-certified for both external and internal use . Glubran® 2 effectiveness in repairing hernias with less post-operative pain, less complications, less hernia recurrences and a greater cost-effectiveness is largely documented . Other cyanoacrylate-based glues are authorized to fix hernia meshes, i.e.: Histoacryl (pure NBCA; classified as class IIb medical device), Liquibond FIX8 (pure NBCA; classified as class III medical device) and Ifabond (n-hexyl-cyanoacrylate; classified as class III medical device). Others are authorized to be used for specific internal indication like Omnex (2-Octyl-CyanoAcrylate [OCA] + Butyl-Lactoyl-Cyanoacrylate), which is indicated for use in vascular reconstructions. Sometimes, abroad, also some cyanoacrylate-based glues are applied for internal uses even if not authorized . The present prospective and randomized study was aimed at comparing the effectiveness and safety of another cyanoacrylate-based glue called Glubran® Tiss 2 (NBCA + OCA), classified as class IIa surgical medical device, CE-marked (under the European Union [EU] Directive 93/42 EEC), being already authorized for use as atraumatic fixation system: Glubran® 2. Both medical devices have previously demonstrated to be well-tolerated and safe. Glubran® 2 and Glubran® Tiss 2 were to be applied by Glutack®, a CE-marked medical device system for glue application in the surgical field. Glutack® is the related Glubran® 2/ Glubran® Tiss 2 applicator device for laparoscopic mesh fixation procedures was fabricated to offer a precise and controlled delivery of Glubran® glues . Glubran® Tiss 2 fulfils the requirements of EU Medical Device Regulation (MDR) 2017/745 (confirmation letter received by the relative Notified Body). The composition of Glubran® Tiss 2 is obtained by mixing two different monomers of cyanoacrylate (NBCA + OCA); this gives the product a better elasticity, while maintaining high levels of tensile strength. In fact, international scientific literature has shown that the common NBCA is the cyanoacrylate molecule with the greatest tensile strength (34.27 N), low elasticity, while OCA has a lower resistance (11.27 N) but has good elastic properties. Glubran® Tiss 2 glue has a tensile strength of 27.34 N and thanks to the presence of OCA, also excellent elasticity . Among its characteristics, this formulation has haemostatic, sealing, bacteriostatic and adhesive properties. Polymerization begins 1-2 seconds after application and completes within 60 seconds. The polymerization reaction generates a temperature of approximately 45°C, which is lower than that of pure cyanoacrylates . Glubran® Tiss 2, indicated also for use in paediatrics, is a sterile, ready for use, blended cyanacrylate adhesive to be used on the skin and mucosal tissues, which is approved as class IIa medical device, effective even in patients anticoagulated and with congenital coagulopathies .
This interventional, post-market, multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device, "the Breast Cancer Locator (BCL)" in Subjects with non-palpable breast cancer, in Europe.
: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. The secondary outcome was the improvement in the quality of sleep and infants' and parents' quality of life
The common opinion that sensory supply of digit 5 (D5) and medial half of digit 4 (D4) of the hand is by ulnar nerve, while the lateral half of D4 and the remaining digits is by median nerve is an oversimplification of a complex topic. Indeed, the literature demonstrated that both the median and ulnar nerves display a number of deviations to the traditionally taught branching patterns. The aim of our study was to investigate the physiological role of median and ulnar nerves in the sensory supply of D4.
The aim of the study is to demonstrate the efficacy of PENG block as the main anesthetic technique to manage perioperative analgesia for hip fracture surgery compared to femoral and obturator nerve block in patients with contraindications to spinal anesthesia.
Obesity is a significant health issue that increases the risk of serious cardiovascular problems. In recent years, two dietary methods, the Ketogenic Diet (KD) and Intermittent Fasting (IF), have become popular for their potential to treat obesity and its related issue, hypertension. While both diets are known for their effectiveness in weight loss, their specific impacts on blood pressure (BP) and overall heart health risks are less understood especially in menopausal women. The main goal of this study was to investigate how the Ketogenic Diet and Intermittent Fasting compare to a regular, unrestricted diet (referred to as Free Diet or FD) in terms of their effects on clinic blood pressure levels in menopausal women. Additionally, the study looked at changes in Body Mass Index (BMI), the percentage of total body weight loss, body fat percentage, waist and hip measurements, the ratio of waist-to-hip size, and the Phase Angle (PhA), which is a measure of the body's overall health status.
Few data are so far available regarding the adult normal values of circulating NKT-like cell concentration, and none for the pediatric population. The primary objective of this study is to determine the reference values for NKT-like cells in pediatric and adult patients (derivation cohort). The secondary objective is to validate the results obtained from the adult derivation cohort with those obtained from an adult validation cohort, consisting of a group of healthy adult volunteers.
Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)
Lichen planus (LP) is a chronic mucocutaneous inflammatory disease of unknown etiology. In its oral variant, oral lichen planus (OLP) has a reported prevalence ranging from 0.5% to 2.2% in the general population. The disease typically occurs between the ages of 30 and 60. Although the pathogenetic mechanism and the triggering factor remain unknown, an immune-mediated pathogenesis and the role of factors such as stress, anxiety, diabetes, other autoimmune diseases, hypertension, intestinal pathologies, chronic liver diseases, hypercholesterolemia, infections have been hypothesized , contact with dental materials, tumors and genetic predisposition to cancer. Oral lichen planus is one of the potentially malignant disorders, showing a malignant transformation rate of 1.4%. A preliminary analysis conducted in our research center has shown a correlation between OLP and systemic tumors, both solid and haematological, involving areas not involved in lesions attributable to OLP. According to these data, the objective of the study is to evaluate whether there is an association between OLP and peripheral tumors, both solid and haematological. The primary objective will be to investigate the possible existence of a statistically significant association between OLP and the development of systemic oncological pathologies. Secondary objective will be to investigate the existence of an association between the various forms of OLP and specific oncological pathologies and to evaluate whether the presence of other systemic pathologies and lifestyle factors (diabetes, hypertension, chronic liver disease, smoking, alcohol, infection by HPV, HCV, etc ...) could influence such association (primary outcome). The objectives will be pursued through the analysis of data collected from the medical records of patients belonging to the General Dentistry and Orthodontic Outpatient Clinics at the "Agostino Gemelli" Teaching Hospital and in the Oral Pathology Outpatient Clinics of the other centers involved.
This study explores the effectiveness od the Crohn's Disease Exclusion Diet (CDED) as a tretament for adults with mild-to-moderate Crohn's disease (CD). The hypotesis is that CDED, by excluding specific dietary components thought to exacerbate gut inflammation, can induce remission in CD patients more effectively than a control diet based on the Mediterranean pattern. Conducted as an open-label randomized trial, the research aim to provide real-world evidence of CDED's safety and its inpact on clinical remission, body composition and overall quality of life for CD patients.