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.
Investigators will compare two different approaches of postoperative drainage after the standard water-seal drain has been used efficiently; one is by using urine bag and check it get blown by the leaked air, two is by using clamping of the water seal drain. Investigators will compare them depending on several factors such as; cost effectiveness, hospital stay, duration of putting the drain and more, reinsertion of the chest tube and others.
Digital therapy may provides real time visual feedbacks. Instrumented devices objectively quantify the patient's performance during rehabilitation and thus could be helpful for the personalization of the exercises. The interactive ball of this trial allows measuring both movement and pressure applied on it. Therefore, the objectives of this study are: (i) to evaluate whether the use of a novel digital therapy gaming system was therapeutically relevant during shoulder rehabilitation; (ii) to understand whether the device was effective in improving patients' engagement in comparison to a control non-gaming rehabilitation program.
Accurate estimation of the glomerular filtration rate (GFR) is crucial for the management of kidney recipients, since it is the most predictive parameter of allograft failure that drives patient monitoring and decision-making. Standard and recent race-free GFR equations have been developed in native kidneys, but their performances in transplant kidney population remains unknown. We aimed at developing a kidney-transplant-specific GFR equation, and comparing its performance to standard GFR equations.
Immunotherapy has become the standard of care in different advanced malignancies. Its effectiveness in the palliative setting was demonstrated by several phase III trials. However, the response rate varies according to the cancer under study and to the line of treatment. A potential way to improve the activity of single agent immune checkpoint inhibitors (ICIs) is to enhance the clinical response through further antitumor agents, including radiotherapy. Studies showed that carbon ions may lead to a broader immunogenic response; for their dosimetric characteristics it is possible to reduce integral dose sparing immune cells to direct and sustain a tumor specific immune response. Considering the available preclinical and clinical evidence together, the goal of this study is to explore the feasibility and the clinical activity of adding carbon ion radiotherapy (CIRT), employed with a fractionation strategy comparable to stereotactic body radiation, to ICIs in advanced malignancies where immunotherapy is currently the standard of care.
This is a dose escalation study involving stage IV breast cancer patients not progressing after 6 months of first line systemic treatment. Potential advantages of stereotactic body radiotherapy (SBRT) in treating breast primary tumor in metastatic breast cancer are: - radio-biological advantage of a short highly effective treatment schedule - possibility of preventing lesions to become symptomatic - possibility of continuing systemic treatment without interruption
This is an open-label, randomized, 4-way crossover, monocentric, controlled study in patients (3 ≤ years of age ≤ 20 )) with phenylketonuria (PKU). The primary comparison will be between the test product (PKU GOLIKE PLUS 3-16, a prolonged-release amino-acids (AAs) mixture) and the reference product (an immediate-release free AAs mixture with the same qualitative and quantitative composition of PKU GOLIKE PLUS 3-16). PKU GOLIKE PLUS 3-16 is a food for special medicinal purposes (FSMP) for the dietary management of PKU. The study will consist of a screening visit (T0), four test days taking place on Sunday (T1-T4), each separated by a washout period (a period of time when a participant is taken off a treatment in order to eliminate its effects) and with the study products being self-administered at home, and a final visit (T5). Following informed consent and verification of eligibility criteria, 24 patients with PKU will be randomized in a 1:1:1:1 ratio to one of the four randomization sequences ABCD, BDAC, DCBA or CADB. A, B, C and D will be: A. One day treatment with 3 self-administrations of GOLIKE PLUS 3-16 (1.2 g/kg total daily dose of AA) B. One day treatment with 2 self-administrations of GOLIKE PLUS 3-16 (1.2 g/kg total daily dose of AA) C. One day treatment with 3 self-administrations of free AAs (1.2 g/kg total daily dose of AA) D. One day treatment with 2 self-administrations of free AAs (1.2 g/kg total daily dose of AA) GOLIKE PLUS 3-16 and the free AAs mixture will be the only protein substitute allowed on each test day, and no sports activities will be allowed on the test days. 24-hour urines and five blood spots will be collected on each test day. A patient's diary will be used to collect information on patient compliance, 24-hour urines and blood spot collections, diet, daily activities, adverse events and concomitant medications. Patients completing all four test days will be asked to go to the center for a final visit (T5) taking place within 2 weeks from the last product administration.
Objective: To prospectively evaluate clinical outcomes during guideline-recommended LMWH dose escalation for recurrent VTE during LMWH or DOAC treatment for cancer-associated thrombosis. Study design: International, prospective, observational cohort study Study population: Adult cancer patients with symptomatic or incidental recurrent VTE while receiving LMWH or DOACs for acute VTE are eligible. Main exclusion criteria include anticoagulant treatment for the recurrent VTE for more than 72 hours, severe hepatic dysfunction, active bleeding, recent major surgery, uncontrolled hypertension, known bleeding diathesis, and a life expectancy of less than 1 month. Study procedures: Patients will be managed at the discretion of the treating physician, who will be encouraged to follow guideline recommendations. These guidelines suggest supra-therapeutic dose LMWH for 4 weeks (+/- 5 days) followed by therapeutic dose LMWH or therapeutic dose DOAC, while it is suggested to treat patients with VTE recurrence during maintenance dose LMWH (i.e. 75 to 80% of full therapeutic weight adjusted dose) with therapeutic dose of LMWH or DOAC. Main study parameters/endpoints: The co-primary outcomes are new symptomatic or incidental recurrent VTE during 3 months of follow-up and on-treatment major bleeding. Secondary outcomes include recurrent incidental VTE, recurrent symptomatic VTE, recurrent incidental or symptomatic proximal or distal DVT, recurrent incidental or symptomatic PE, clinically relevant non-major bleeding, all-cause mortality, and cancer-related mortality. VTE occurring at other sites such as cerebral DVT or splanchnic DVT will also be recorded.
Chronic kidney disease (CKD) is a global health concern because more than 10% of the world's population have it, its prevalence is increasing, and CKD is an important contributor to morbidity and mortality for this population. The majority of the people with CKD aren't aware and there are not available tools for early CKD detection and for an accurate prediction on these patients. Many CKD patients exhibit progressive renal dysfunction, demonstrating a failure of current, non-specific therapeutic strategies. Better methods are urgently needed for i) early diagnosis of CKD, and prediction of its progression for improved stratification of patients and better targeting of current treatments; and ii) to directly assess structural and functional responses of the kidney to new therapies and identify those patients who respond. Over the past decade, renal Magnetic Resonance Imaging (MRI) has emerged as a promising technique for improved understanding and characterisation of renal pathophysiology. Compared to histopathology, MRI is non-invasive and avoids sampling bias by characterising the entire kidney with high spatial resolution. In spite of a number of single centre studies showing renal MRI feasibility and potential to address a number of key clinical questions, current methodological differences across studies hinder reliable comparisons of the results, which can only be regarded as preliminary. Standardization of acquisition and processing protocols across centres is therefore needed, and this will also lead to the possibility to provide preliminary data of the multiparametric renal MRI clinical validity and utility. The purpose of this study is to standardize, assess the feasibility and provide preliminary evidence of clinical validity and utility of the multiparametric renal MRI. To reach this goal two groups of subjects are involved: - Group 1 (healthy volunteers). In this group the repeatibility and reproducibility of multiparametric renal MRI will be assessed. - Group 2 (CKD patients). In this group the feasibility, the acceptability, the reproducibility and the preliminary clinical validity of multiparametric renal MRI will be assessed.
The gap between patients awaiting and those undergoing liver transplantation (LT) continues to grow. Marginal organs carry higher risk of failure after LT however they are increasingly used to fill such gap. Viability assessment of the graft is essential to lower the risk of LT failure and need for emergency re-LT, however this still relies mainly on surgeon's experience. Post-LT graft function recovery assessment is also essential to aid physicians in the management of LT recipients and guide them through challenging decision-making. With the present study we aim to validate the use of indocyanine green clearance test (IGT) in two settings: in the donor as an objective tool to assess graft viability; in the recipient to assess graft function recovery after LT. The implementation of IGT in routine practice translates into two main advantages: to avoid using grafts with no chance of recovery and to optimize resource allocation to LT recipients depending on their graft function recovery.
Sleep is regulated by the interaction of homeostatic and circadian processes. The homeostatic process determines sleep propensity in relation to sleep-wake history, the circadian one is responsible for the alternation of high/low sleep propensity in relation to dark/light cues, and is substantially independent of preceding sleep-wake behaviour. The circadian timing system encompasses a master clock in the brain and peripheral, ancillary time-keepers in virtually every organ of the body. In recent years, evidence has emerged that circadian disruption has serious medical consequences, including sleep loss, increased cardiovascular morbidity and increased risk of certain types of cancer. Evidence is also emerging that hospitalization per se weakens circadian rhythmicity, due to disease itself and to modified light, food and activity cues. The aim of our project is to test an inpatient management system (CircadianCare) that limits the circadian impact of hospitalisation by enhancing circadian rhythmicity through an assessment of the patient's specific circadian features/needs and an ad hoc, personalized light-dark, meal and activity schedule to cover the whole of the inpatient stay. This will be compared to standard inpatient management in terms of patients' perception, sleep-wake quality and timing during hospitalisation, inpatient utilization of sleep-inducing medication, length of hospitalisation, and prognosis (i.e. outcome of hospitalisation, subsequent hospitalisations and post-discharge sleep-wake disturbances). The CircadianCare system is expected to benefit prognosis, decrease costs, and change the way hospitals are organized and designed in future, with potential direct relevance to the plans for the new University Hospital of Padova.