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.
Adult Growth Hormone Deficiency (AGHD) is a recognized clinical entity but several barriers concerning patient-clinician communication, inadequate patients' awareness of the disease, low perceived benefit of replacement therapy and poor compliance still remains. The overall goal of the study is to improve AGHD management through a Smartphone app (MAGHD App: Manage Adult Growth Hormone Deficiency) integrated with a software framework able to merge patients daily data on physical activity, quality of life (QoL), and well-being with clinical data collected in institutional databases. The target population consists of 100 patients with a previous diagnosis of AGHD, whether in treatment with growth hormone or not. In a prospective 24 months study, MAGHD App will be developed and connected to MAGHD Framework. This system will allow to integrate: 1) Physical Activity Data collected by wearable devices, 2) Patient Related Outcomes Data, periodically inserted by the patients through MAGHD App in response to questions extrapolated from validated questionnaires, 3) HCP Data registered in clinical databases and including medical history, biochemical and radiological examination. Data will converge in MAGHD Framework where they will be analyzed and used to create reports visible to patients (in MAGHD App) and clinicians (by a monitoring dashboard). The results are expected to positively influence AGHD management by involving patients in care process and giving clinicians a useful tool for clinical practice.
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
Aim of the study is to assess efficacy of a short course radiation treatment in patients with symptomatic brain metastases from solid tumors
Data about the impact of growth hormone treatment on insulin sensitivity in children are quite controversial, due to the different surrogate indexes that have been used, like Homa-IR, QUICKI, ISI-Matsuda or adipokine levels. The investigators aimed to evaluate insulin sensitivity through the euglycemic hyperinsulinemic clamp, considered the gold standard technique, in children affected by growth hormone deficiency and to compare the M-value with the most commonly used surrogate indexes of insulin sensitivity.
Edoxaban, has shown in clinical registration trials a significant reduction of major bleeding compared to warfarin, especially in elderly patients. Efficacy and safety of edoxaban will be assessed in a cohort of very elderly patients (≥80 years of age) with NVAF. A secondary analysis will correlate outcomes with frailty defined according to SHARE-FI (not-frail, pre-frail or frail).
Pancreatic cancers represent a challenge for the multidisciplinal team. A patient-tailored treatment plan requires an accurate preoperative staging. Currently more than 40% of patient taken to the OR are actually unresectable and another 40% will shortly recur with dismal prognosis. Among patients that meet upfront surgery some would have benefit of a neoadjuvant treatment and vice versa. Accuracy of preoperative staging is of primary importance in treatment decisional making. Due to its location, invasive preoperative diagnostic tests on pancreatic cancer are expensive and risky. Liquid biopsy provides a non-invasive signature of the tumor. Analyzing mutations on cell-free nucleic acids gives translational information on tumor biology and therefore on its clinic-pathological features and likely on its progression. This study would be the first -in our knowledge- analyzing the relationship of a pattern of 4 major genes involved in pancreatic cancer progression on liquid biopsy and the time to recurrence and T-stage, with particular attention to vascular invasion. A properly staged patient provides a better resource allocation, an optimal treatment plan and improves patient's outcomes.
The purpose of this trial was to assess the ability of eltrombopag to induce sustained treatment-free remission in immune thrombocytopenia purpura (ITP) subjects who relapsed or failed to respond to an initial treatment with steroids.
The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.
Bariatric-metabolic surgery is effective in treating the cluster of conditions forming the metabolic syndrome, strictly associated with NAFLD and NASH. Recently, we and other authors have shown also in the long term (up 5 years) with randomized-controlled trials (RCTs) that bariatric-metabolic surgery allows remission of type 2 diabetes and obesity reduction, which are the two major pathogenetic factors of NASH development, with maintenance of weight loss. Few small and mainly retrospective studies have shown that bariatric surgery is effective in improving NASH histologic picture in obese subjects. The aim of our proposal is to conduct a 3 arm single centre, superiority, RCT comparing Roux-en-Y Gastric Bypass (RYGB) with Sleeve Gastrectomy (SG) and with Intensive Lifestyle Modifications (ILM) for the treatment of Non-Alcoholic Steato-Hepatitis.