There are about 16228 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 goal of this study is to determine how a structured and supervised physical activity program linked to Dragon Boat practice can improve motivation to participate in physical activity sessions. It is also the purpose of this study to evaluate the improvement in body composition, body image perception and physical function. For this purpose, a group of women operated on for breast cancer was recruited and divided into two experimental groups: one group participated in a structured program of Dragon Boat while the other followed a home-based program of exercises independently in the home environment. Anthropometric measures (weight, height, BMI) and arm circumference, data on lifestyle and psychological well-being were evaluated by means of questionnaires. Tests were also performed to assess shoulder strength, aerobic capacity and mobility. The results of this study will (a) identify the strategies used that make Dragon Boat activity effective in ensuring quality participation in physical activity, (b) define the physiological effects of Dragon Boat activity on physical functionality and (c) correlating objective measures with subjective perceptions thanks to the integration of new body composition analysis techniques (regional BIA) and validated questionnaires on the perception of body image.
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL) and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with these malignancies, leaving a very small population of relapsed/refractory disease with a poor prognosis. The purpose of this study is to assess the safety and tolerability of epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia. Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at 50 sites globally. Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be followed for a minimum of 3 years after enrollment. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
The diagnosis of secondary hypoadrenalism and GH deficiency (GHD) often requires the performance of a dynamic test. The glucagon stimulation test (GST) is one of the options for evaluating hypothalamic-pituitary function, representing a stimulus for both the corticotropic and somatotropic axis, substantially safe and easily available. The standard procedure involves the intramuscular injection of 1-1.5 mg of glucagon based on the patient's weight. In addition to its antero-pituitary function, glucagon has also shown its ability to stimulate neurohypophyseal secretion. Using the copeptin dosage, it has been shown that after the administration of glucagon in healthy subjects there is a significant release of ADH. However, the available data are scarse and there is no standardized protocol for the use of the glucagon test in diabetes insipidus. At the moment, GST is not the most frequently chosen diagnostic option. In fact, despite having the advantage of being able to investigate different areas of anterohypophyseal and probably posterohypophyseal function at the same time, the test has some disadvantages: the prolonged duration makes the procedure challenging, the intramuscular injection can be unwelcome, and many variables can come into play in the definition of a normal response (age, BMI, glycemic status). The recent introduction of a single-dose nasal powder formulation (Baqsimi®) could overcome some of the limitations of classic GST and make the procedure less demanding. To date, no assessments are yet available regarding a purely diagnostic role in the context of hypopituitarism of this new formulation. Through the knowledge of the physiological response of the adrenocortical, somatotropic and ADH axis to the administration of intranasal glucagon in healthy subjects, it will be possible to evaluate its possible application in the diagnosis of GH deficiency, central adrenal insufficiency and possibly diabetes insipidus.
Currently, 3 anti-SARS-CoV-2 monoclonal antibody products have received Emergency Use Authorizations from the Italian Medicines Agency (AIFA) for the treatment of mild to moderate COVID-19 in non hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization (bamlanivimab plus etesevimab, sotrovimab, and casirivimab plus imdevimab). The study aims at assessing the non-inferiority of bamlanivimab plus etesevimab and sotrovimab vs. casirivimab plus imdevimab (reference standard due to the wider evidence gathered on its efficacy) on COVID-19 progression in patients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of casirivimab plus imdevimab at an early-stage of COVID-19, a disease progression of 5% has been estimated in the reference arm. 5% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment with monoclonal antibodies (20%, based on national data) and the efficacy of the reference standard. Therefore, 1260 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.
This Phase Ib/IIa study has been designed according to a 3+3 dose escalation/dose expansion design. A dose expansion will be conducted at both the intermediate and high dose levels, if tolerated, with the purpose of generating additional and more robust safety and preliminary efficacy data. No control arm was included, as the target patient population of this study consists of patients in whom the overall survival is less than 6 months and treatment options are very limited and often poorly tolerated, making unlikely that the study results can be significantly biased.
This study evaluates the safety, tolerability, PK, and preliminary efficacy of AZD0466 as monotherapy or in combination with other anticancer agents in patients with advanced NHL
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.
The purpose of this study is to compare the percentage of early micromibilisation in unicompartmental knee arthroplasties in robot-assisted technique vs standard technique.
The aim of the study is to evaluate the efficacy and safety of different dosage regimens of the combination methocarbamol/paracetamol in the treatment of patients with acute non-specific Low Back Pain.
Thoracic complications directly or indirectly consequence of COVID-19 (including either pathologies strictly related to the infection, or iatrogenic effects of therapeutic attempts to treat it) have been described during the pandemic. Many of the above conditions often require a surgical approach but, based on published data reporting high early postoperative morbidity and mortality, many experts initially advised against any referral to surgery in COVID-19 patients. Therefore, the issue is if salvage surgical approach should be always excluded or could be considered when it represents the only remaining effective option. In the absence of solid data and recommendations, this is a demanding challenge for thoracic surgeons We have coordinated a multicenter study to collect the experience of several worldwide high-volume thoracic surgery departments. Our objective is to investigate efficacy and safety of surgery in COVID-19 patients who developed thoracic complications that required operative management.