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.
The aims of this study are to investigate the short term effects of MUFA alone vs. MUFA plus Polyphenols contained in the extra-virgin olive oil (EVOO) on the postprandial glycemic response in patients with type 1 diabetes and to explore the possible mechanisms through which MUFA alone or MUFA plus Polyphenols contained in EVOO could influence postprandial glycaemia.The intervention will be preceded by two-weeks run-in period during which participants will consume an usual olive oil, fill-in a 7-day dietary food record and practice continuous blood glucose monitoring (CGM) in order to optimize basal insulin infusion values and the insulin-to-glycemic load ratio.The study will be conducted according to a randomized cross-over design. The participants will consume, in random order at a distance of one week from each other, a meal-test seasoned with extra virgin olive oil rich in polyphenols (EVOO + POLY) or a meal-test seasoned with olive oil poor in polyphenols (OO-POLY). Upon fasting and during the 6 hours following the meal, patients will undergo to: 1. Venous blood drawing samples for the evaluation of gastrointestinal hormones, markers of systemic inflammation and oxidative stress. 2. Breath test with 13C-octanoic acid, for the study of gastric emptying. During the experimental period the participants will undergo to continuous glucose monitoring wearing sensors 7 days/week. The results of this study will allow optimizing insulin therapy based on the macronutrient composition of the meal in patients with type 1 diabetes mellitus treated with insulin pump. This will improve glycemic control and quality of life of these patients and reduce the risk of developing chronic diabetes complications.
The purpose of this study is to assess the safety and efficacy of a newly developed psychotherapy for schizotypal personality disorder. This new form of psychotherapy integrates compassion focused therapy and metacognitively oriented psychotherapy.
The study aim is to compare the effects produced by two different exercise training modalities on atrial function evaluated by speckle-tracking echocardiography on hypertensive patients with coronary artery disease. 50 males patients will be randomized to interval training or combined training the latter including both aerobic and resistance exercises. The training period will last 12 weeks. The protocol will provide two different assessment of atrial function: -acute: after a single session of exercise; - 12 weeks: at the end of exercise training protocols.
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting by procedure group (upper gastrointestinal [GI], lower GI, and gynecological). Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 Curved Jaw and Generator G11 instructions for use.
This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.
Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia scaffold ProFlor
Primary aldosteronism (PA) is the excessive endogenous production of the mineralocorticoid aldosterone. Although various rare forms of PA exist, the vast majority of cases are accounted by either an aldosterone-producing adenoma (APA) or bilateral adrenal hyperplasia. During the last decades the prevalence of PA has risen, predominantly due to better awareness of disease. Several studies estimated a prevalence of PA up to 17% in an unselected population of hypertensive patients. However, in a population with resistant hypertension the reported prevalence is even higher: 17-23%. This emphasizes the clinical impact of PA on morbidity and mortality due to high blood pressure. Since both hypertension and aldosteronism are independent risk factors for cardiovascular morbidity, the aim of treatment is curation or reduction of both. After an adrenalectomy for APA normalization of biochemical abnormalities is achieved in almost all cases. Nevertheless, curation of hypertension (systolic blood pressure <140 and diastolic blood pressure <90 mmHg) without the need of antihypertensive medication is accomplished in only 35-45% of the cases. In 2008 the Aldosteronoma Resolution Score (ARS) was developed. This score predicts the likelihood of complete resolution of the hypertension in patients with an aldosteronoma and has been validated by other investigator groups. Reduction of hypertension is also an important clinical outcome and is reported in 90-98% of the patients after surgery. In most studies reduction is defined as a certain decrease in blood pressure or antihypertensive medication. However, there is no consensus on the precise definition of reduction in these patients, which leads to incomparable results. The aim of the proposed study is to determine the proportion of patients with clinically relevant reduction of hypertension after adrenalectomy in a large cohort. Furthermore, the investigators aim to determine the characteristics predicting this clinically relevant reduction. Additionally, the investigators evaluate the predictive value of the Aldosteronoma Resolution Score for clinically relevant reduction and aim to develop a scoring system to help clinicians predict the likelihood of reduction of hypertension after adrenalectomy so it can be used for patient counseling.
Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using 3D technology.
The purpose of this dose finding/comparative efficacy study is to first single out the most appropriate dose of mannitol for bowel preparation (phase II) and, subsequently, demonstrate the non-inferiority of the efficacy of single dose mannitol vs standard split 2L PEG ASC (Moviprep®) (phase III) in bowel preparation for colonoscopy .
The investigators have thought with a dedicated research group, to deepen the use of receptive music therapy so that it can improve the non-nutritive sucking of premature babies through listening to lullabies sung by parents and by the music therapist, which can reduce the use feeding tube and the negative effects on stress or growth of the newborn. The acquisition of oral skills and the achievement of a complete autonomous suction are of fundamental importance for the discharge of the preterm infant. Some studies published in the literature suggest that listening to the mother's voice and lullabies can represent a positive auditory stimulus for babies to support nutritional and non-nutritive sucking (NNS). Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief receptive music therapy intervention with the infant's personal pacifier that plays lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospitalization. The possible negative effects of this stimulation on infant stress or growth remain to be explored. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time also to observe the possible effects on his well-being and on his clinical stability.