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 study prospectively observed the complications intended as diarrhea or sti-sis that critically ill patients developed within 7 days after ICU admission. In addition, secondary aims investigated through bioimpedenziometry the loss of lean body mass and changes in phase angle during the same period of ICU stay.
TThe research aims to verify the Italian adaptation of a parent-mediated group training focused on social skills for adolescents with autism spectrum disorder (ASD). The Program for the Education and Enrichment of Relational Skills PEERS® is an evidence-based program with substantial literature (over 40 studies) applied in several countries. For the present study, about 40 adolescents, both boys, and girls with ASD, are enrolled and randomized into two groups. Groups (experimental group and waiting list) took part in the Italian telehealth adaptation of PEERS® at different times and were evaluated at several time points (baseline, pre-treatment, post-treatment, and follow-up). The objective of the comparison was to explore the primary outcomes, such as the impact of training on social knowledge and performance, and secondary outcomes, like psychiatric comorbidities and neuropsychological profile. The hypothesis is that social skills (knowledge and performance) improve after training in the experimental group and affect the secondary outcomes, and the achievements are maintained at 3-months follow-up.
Quality of life (QoL) assessment is a milestone of clinical practice in gynecology. In particular, the use of validated QoL questionnaires is of the utmost importance for pelvic floor disorders, due to their functional nature and high prevalence. Pelvic floor dysfunctions such as lower urinary tract, bowel and sexual dysfunctions often coexisting with pelvic organ prolapse affect a substantial proportion of women and can often cause bothersome symptoms and have a negative effect on psychological and social well-being. Assessment of QoL in women with pelvic floor dysfunctions is essential for making a diagnosis and designating an adequate treatment. Therefore, it is necessary to evaluate women's subjective perception. A valid way to measure the patients' perspectives is through self-administered questionnaires that can address the presence and severity of symptoms, and their impact in daily activities and QoL. Symptom severity and QoL can be assessed by two specific questionnaires, the Pelvic Floor Distress Inventory (PFDI-20) and the Prolapse Quality of Life (P- QOL).
The participants presenting with hand problems and meeting the inclusion criteria are asked to apply the study product for one month. They are evaluated before and after treatment.
Aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged >/= 70 years old treated in our department, and explored association between baseline age, G8 score and Charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.
Non-celiac gluten sensitivity (NCGS) is a condition characterized by gastrointestinal and extraintestinal symptoms which are triggered by gluten ingestion in the absence of celiac disease (CD) and wheat allergy. In the last years studies suggested that wheat components other than gluten can be responsible of symptom's triggering, thus the term "non-celiac wheat sensitivity" (NCWS) has been proposed as a more appropriate label. To date, different pathogenetic mechanisms have been proposed, but no conclusive data have been reported; among these, some study groups a possible role of innate immunity and of Natural Killer (NK) cells. KIR (Killer Immunoglobulin-like Receptors) regulate the activation of NK cells through their interaction with Human Leucocyte Antigens (HLA). Both KIR and HLA loci are highly polymorphic, and, in the case of KIR, two main haplotypes have been identified: A and B. Haplotype A is the simplest and correlates mainly with NK inhibition, while haplotype B has a variable number of genes, most of which activate NK cells. The investigators hypothesis is that the genetic variants of KIR, which define the haplotype "inhibitor" or "activator", can affect the development and the course of NCWS too. Thus, the researchers aimed to:1. Identify putative KIR genetic variants in NCWS patients (50 subjects) respect to celiac disease patients (50 subjects) and blood donors (50 subjects); 2. Evaluate the possible association of KIR genetic variants with specific clinical manifestations of patients with NCWS.
This is a randomized phase II, open label, two arm study, evaluating the efficacy of panitumumab in combination with Trifluridine-Tipiracilas third line therapy, after a first line containing an anti-EGFR agent panitumumab(at least 70% of study population) or cetuximab in metastatic colorectal cancer (mCRC) patients.
Liver cancer in adult men is the fifth most frequently diagnosed cancer worldwide, and is the second leading cause of cancer-related death in the world. To date, liver surgery is the treatment of choice for those patients with resectable disease. However, still today the proportion of resectable patients is limited due to a large proportion of patients presenting with advances disease. For these patients, the treatment consists of systemic chemotherapy, which unfortunately is associated with median survival of 12 months. The choice of the appropriate treatment scheme adheres to the standard guidelines based on the results of clinical trials. Of note, in case of HCC and MFCCC very few international approved therapeutic guidelines are available. In particular, there is no agreement among specialists about the use of chemotherapy as adjuvant treatment after hepatic resection for HCC or MFCCC. An important aspect of the postoperative "adjuvant therapy" is the possibility to enhance the recovery after the operation. Indeed, the possibility to accelerate the functional recovery in a patient who receives a major cancer operation is of paramount importance. In this sense, having a product that might help the patients' recovery should be one of the priorities of the medical and pharmaceutical industry. To our knowledge, there are no previous studies that investigated such an important aspect.
The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.
The clinical characteristics of MS are extremely variable from one patient to another. In about 60% of cases, motor disabilities are associated with cognitive deficits. The present study aims to compare three forms of cognitive / motor rehabilitation in three groups of patients with MS: rehabilitation of verbal memory with the Rehacom program; combined rehabilitation, associating a motor rehabilitation path with the Rehacom program; only motor rehabilitation course. Aims of the study will be: to verify whether the combined cognitive / motor rehabilitation can induce a significantly greater improvement in the memory performance of patients with MS compared to rehabilitation alone; check whether any improvement is objectively verifiable by patients and the impact it may have on patients' quality of life; monitor these effects after 6 months. For these purposes, three homogeneous groups of 20 patients each will be enrolled, diagnosed with MS according to Mc Donald's criteria revisited by Polman (2011). The study will be divided into an initial clinical, cognitive, emotional, quality of life and functional self-perception (T0) assessment. Subsequently, the patients assigned to the three conditions will be provided with the pre-established rehabilitation treatments for a total duration of 12 weeks; at the end, each patient will undergo an overall re-evaluation (T1). Finally, a further overall reassessment will be carried out after 6 months, aimed at follow-up monitoring (T2). Statistical analyzes will be of two types: Within Group (aimed at assessing any improvement in the cognitive performance of each group of patients by comparing the assessments at T0 with those at T1 and T2); Between Group (aimed at comparing the results obtained by each group with those of the other 2 groups at T0, T1, and T2).