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.
Chemotherapy-induced alopecia (CIA) is one of the most common and emotionally distressing side effects of cancer therapy. In this study we sought to assess the feasibility and the effectiveness of scalp cooling system DigniCap® to prevent alopecia in primary breast cancer patients receiving an anthracycline containing adjuvant chemotherapy (CT). A prospective two-stage design clinical trial conducted at a single Institution of women with primary breast cancer scheduled to receive anthracycline with or without taxane-based adjuvant CT. Patients were enrolled from July 2014 to November 2016, with ongoing annual follow up for 5 years. The scalp cooling period initiated approximately 30 minutes before CT. Scalp temperature was to be maintained at 3-5°C throughout CT and for 90 to 120 minutes afterward, depending on the CT drug and dose.
To evaluate the effectiveness of an experimental rehabilitative protocol with specific tasks for the improvement of body awareness and the motor scheme in the patient with multiple sclerosis (EDSS <2.5). Primary outcome: improvement of the interoception (awareness of the body) and of the related motor capacity Secondary outcomes: improvement of balance and postural self-correction control
Wheat is one of the most important crop for humans and it represents a source of multiple nutrients, dietary fiber and bioactive compounds, especially if consumed as wholegrain. Several studies have suggested that Triticum heritage varieties could present a healthier and better nutritional profile than modern wheats, by providing more vitamins, minerals and nutraceutical compounds. Although the effect of ancient grain consumption have been partially investigated in both animal and human studies, the potential impact of Triticum heritage varieties compared to modern ones on post-prandial glucose metabolism is still unclear. Thus, the aim of the study was to evaluate the impact on post-prandial glycaemia and insulinemia of different types of breads formulated with flours derived from mix of heritage varieties belonging to the Triticum genus selected and cultivated in specific areas of Emilia Romagna region, compared to breads made with conventional/modern wheat flours.
Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.
Objective. The aim of the study was to evaluate the effectiveness of an educational program, based on Students 4 Best Evidence (S4BE) Blog, on Evidence-Based Practice (EBP) competencies (attitudes, knowledge and skills) through an EBP laboratory, in undergraduate students of Physiotherapy. Design. An observational perspective study. Setting. Physiotherapy School of Italian University. Participants. 70 undergraduate physiotherapist students of the first year, of both genders, were included. Mean age was 20.48+/-3.20 years and 66% were male and 34% were female. Interventions. The intervention consisted of the use of S4BE to teach EBP competence. The section S4BE "about" has been used to teach the EBP principles and their key steps and the section S4BE "topics" has been used to teach critical thinking and the clinical practice in rehabilitation for a total of 24 training hours. Main Outcome Measure. The evidence-based practice questionnaire (EBP2Q) has been used to evaluate EBP attitude, knowledge and skills, at the start of laboratory (T0), after 24 training hours (T1) and after 3 months of clinical practice training (follow-up). Statistical analysis was performed with SPSS 17.0 An intra-group analysis has been conducted to verify the improvement during the time. Statistically significant was set at p<0.05.
This is an independent optional sub-study parallel to TARGET-HCC (NCT02954094). The purpose of Direct-Acting Antiviral-Post Authorization Safety Study (DAA-PASS) is to investigate the impact of exposure to direct-acting antivirals (DAAs) on early recurrence of hepatocellular carcinoma (HCC) in hepatitis C virus (HCV)-infected patients following successful HCC treatment interventions.
Diaphragm ultrasound non-invasively explores the diaphragm function and it can be useful in several clinical situations. Diaphragm ultrasound is able to evaluate the cranio-caudal displacement of the diaphragm and its thickening fraction at the end of inspiration, in relation to the end-expiratory value. While several studies have been conducted in the evaluation of educational programmes for echocardiography, to date data lack regarding this aspect in diaphragm ultrasonographic assessment. Based on the experience gained in some specialization schools in Anaesthesia and Intensive Care, the investigators hypothesize that the participation in a two-hour course, including a theoretical part and a practical training, allows to acquire the appropriate theoretical and practical skills necessary to correctly perform the measurement of the diaphragm excursion and thickening fraction, compared to the theoretical lesson only, followed by a brief explanation by an expert tutor, on the practical use of the ultrasound. The investigators hypothesized that the association of the theoretical part and of the practical training is able to obtain: 1. Passing the theoretical test with at least 70% of the correct answers; 2. The correct identification of the areas where the probe is affixed; 3. The appropriate measure of Diaphragmatic thickening and displacement.
Aim of the study is to evaluate efficacy of freestyle Libre system (flash glucose monitoring) in real life in term of Glycated Haemoglobin reduction and acceptance of the system evaluated through validated questionnaires after 3 and 6 months of device's use.
This is a global, multicenter, randomized, double-blind, stratified, vehicle-controlled study of the efficacy and safety of Patidegib Topical Gel, 2%, applied topically twice daily to the face of adult participants with Gorlin syndrome. Participants will be required to apply the investigational product for 12 months. The primary endpoint is a comparison between the two treatment arms of the number of new BCCs that develop over the 12 month period.
A disposable negative wound pressure device will be compared to standard sterile wound dressing in reducing the rate of wound infection after clean-contaminated surgical procedures on biliary tract and pancreas in patients at high risk for wound infection.