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 is a Phase 2 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of cystic fibrosis in patients 12 years of age or older. Approximately 415 subjects will be enrolled in this study at about 100 sites in North America, and Europe. The planned duration of treatment with study drug is 28 weeks. Study drug will be lenabasum 20 mg BID, lenabasum 5 mg BID, and placebo in a 2:1:2 ratio.
Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter (8cm). The clinical efficacy of both procedure is comparable. This study intends to investigate if clinical outcomes of POEM depends on the length of esophageal myotomy, in patients with classic-type achalasia (type I and type II according to Chicago Classification)
This study is a randomized, controlled study, with the primary objective to demonstrate non-inferiority of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection, and with the secondary objective of evaluating the safety of Hemopatch compared to TachoSil.
Management of older cancer patients is challenging, due to a lack of good quality evidence to guide treatment decisions, as well as the wide variability in the level of fitness for treatment of elderly patients. Oncologists are faced with the challenge of determining the most suitable treatment for an individual taking into account their comorbidities, competing causes of death, quality of life and functional reserve. Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the western world and ranks second among the most frequent malignancies in Europe in both men and women. The incidence and mortality of CRC strongly increases with age. Approximately 60% of new cases of CRC and 70% of CRC-related deaths occur in patients aged 65 years and older, with about 40% of patients aged 75 years or older. The oncologists' therapeutic decision-making for elderly patients with metastatic colorectal cancer (mCRC) has been largely debated in the last few years, mainly because of the lack of trial-based recommendations, due to the underrepresentation of patients more than 65 years old in clinical trials. As a consequence, therapeutic choices in this setting are frequently driven by data from retrospective, pooled and meta-analyses. These results do not necessarily reflect the general population affected with mCRC and are often limited by potential confounding factors. It is well recognized that chronological age is not an effective criterion on which to base therapeutic decisions. Rather, treatment tolerability in an older cancer patient is primarily related to physiological or biological age, that is the level of fitness, which takes into account factors such as functional status and comorbidities. Physiological age is better assessed with a comprehensive geriatric assessment (CGA), a multidisciplinary evaluation covering domains such as cognitive and mood status, functionality, comorbidities, and nutrition. These deficits are prevalent in older patients but which may be missed with routine evaluation. There is now strong evidence that use of a CGA assessment in a general geriatric patient population can improve health outcomes. While some form of geriatric assessment have been recommended by specialist advisory panels for all elderly patients in whom chemotherapy is considered, evidence of CGA leading to improved outcomes in a geriatric population with cancer is very limited. CGA for older patients with cancer does appear to provide information relating to prognosis, likelihood of toxicity from chemotherapy, and has been shown to influence treatment decisions. However, this approach is time-consuming, leading cancer specialists to seek an easier screening tool that can separate fit older patients with cancer, who are able to receive standard cancer treatment, from vulnerable patients that should subsequently receive a full assessment to guide tailoring of their treatment regimen. The G8 is a simple 8-items screening tool, developed specifically for older patients with cancer. This tool, addressed by the clinician, covers multiple domains, focusing on nutritional status, mobility, neuropsychological problems, medication use, self-rated health status and age. The G8 demonstrated a good sensitivity in identifying patients with impairments across multiple domains when a cut-off of 14 points is adopted. Patients with a score < 14 would be candidate to a CGA. Nevertheless, this cut-off showed poor specificity and negative predictive value. Furthermore, some evidences suggested that the G8 might be able to predict survival, while its predictive value for treatment-related toxicities has not been extensively explored. While literature data support a promising role for G8 as a simple cost-effective screening tool in elderly patients, to date its use in clinical practice is not widespread, and only selected centers with a focus in geriatric oncology routinely perform this assessment to enhance the baseline evaluation of patients before treatment choice. The lack of ''real life population'' data makes it difficult to evaluate the role of G8 in the setting of common practice in an unselected population and to prove its efficacy and reliability outside selected cases. Moreover, recent data suggest how a physical performance test, such as Timed Up and Go, could be a useful indicators of prognosis, functional decline and treatment-related complications. This study is designed to promote a comprehensive evaluation of elderly patients before treatment decisions and to prospectively evaluate the association of G8 assessment with clinical outcome and treatment-related severe toxicity in the real life population of elderly patients with colorectal cancer in Veneto. Additionally, preliminary data on feasibility and reliability of Timed Up and Go measurement as prognostic determinant and dynamic marker, will be collected.
Patients with abdominal aortic aneurysms (AAA) suitable for endovascular aortic repair (EVAR) with Treovance were eligible to participate. Main inclusion criteria were: age 18-85 years; infrarenal AAA without significant infrarenal or distal iliac landing neck calcification or thrombus formation; infrarenal or distal iliac landing neck size requirements specified in the instructions for use. Main exclusion criteria: dissection/ruptured aneurysm or prior AAA endovascular or surgical repair. The primary endpoints were standard EVAR criteria.
To assess the effect of L. casei DG® (Lactobacillus paracasei CNCMI1572; Enterolactis® plus) on abdominal symptoms and gut microbiota metabolism/composition in non constipated patients with IBS (Irritable Bowel Syndrome). Patients will be randomized to receive L. casei DG® capsules, b.i.d. for 12 weeks the a 4 weeks Follow Up period will follow.
Cow's milk allergy (CMA) affects up to 3% of European children. In the absence of an alternative to cow's milk, the management of CMA is based on the use of safe, affordable and nutritionally adequate formulas. In Scientific Societies Guidelines, extensively hydrolyzed casein formula (EHCF) is considered as safe first line approach for the treatment of children with CMA, whereas amino acid-based formula (AAF) is considered as second line strategy in children reacting to EHCF or as first line approach in children with CMA-induced anaphylaxis. Few and not recent studies, involving a poorly characterized study population, suggested that up to 10% of CMA children could react to the extensively hydrolysed formulas. It has been demonstrated that EHCF supplemented with L.rhamnosus GG (LGG) maintains hypoallergenic status and that is able to accelerate oral tolerance acquisition in children with CMA comparing with other formulas. The purpose of this study is to investigate the feasibility of a "step-down" approach in children affected by Immunoglobulin E (IgE)-mediated CMA with the aim to evaluate the effects of EHCF + LGG on oral tolerance acquisition and on immune response and gut microbiota shaping.
Observational study looking at the burden of illness in achondroplasia subjects aged 5-70. The study will include a 5 year review of historical clinical data as well as a single point collection of questionnaire data to look at the impact on the following in individuals with achondroplasia versus a normative population: - Quality of life - Clinical burden - Healthcare resource use - Socio-economic burden - Psychosocial burden Up to 300 subjects will be included in sites in Germany, Spain, Italy, Sweden, Austria and Denmark
Study to investigate response to sunitinib in patients with thymic epithelial tumours who had progressive disease after at least one previous regimen of platinum-based chemotherapy.
The primary objectives of this study are to evaluate the efficacy of gefapixant (MK-7264) in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of gefapixant. The primary hypothesis is that at least one dose of gefapixant is superior to placebo in reducing coughs per hour (over 24 hours) at Week 24.