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.
The aim of the CORONA.BOT project is to exploit the Artificial Intelligence methods of Generator Real World Data Facility to automatically extract structured and unstructured data from hospital databases and to implement an early risk assessment (warning system) regarding the negative outcome for patients infected with SARS-CoV-2. The objective of CORONABED.BOT is to analyze the care pathways of patients from the same cohort as CORONA.BOT, in order to identify the total length of stay, intensive care occupations and flows between departments, based on variables demographics and first entry clinics Early identification of patients with symptoms compatible with SARS-CoV-2 infection will enable more rapid activation of isolation procedures, contact monitoring/contact history and decisions on the most appropriate clinical pathway in terms of type of treatment and unit. Similarly, the identification of factors correlated with worse outcomes will allow more effective planning for the use of critical resources (such as intensive care and others).
Sepsis is a life-threatening condition, caused by a systemic infection. It is particularly dangerous in already fragile populations and needs to be identified quickly to be treated as fast as possible, as discussed during the 2016 sepsis consensus and highlighted by the 2021 Surviving Sepsis Campaign. Yet, while there are scores to quickly identify patients who are at an increased risk of mortality (namely quick-SOFA, q-SOFA), these scores are also highly unspecific and cannot guarantee an adequate risk stratification. Therefore, it would be extremely valuable to further stratify mortality risk in patients who present to the emergency medical evaluation, especially those who present with stable hemodynamics but are at increased risk of decompensation during hospital stay. Furthermore, in the emergency room, it is sometimes impossible to re-evaluate patients regularly, thus, it would be important to immediately identify high-risk patients. Unfortunately, at the moment, there is no consensus. Through this study, the investigators will try to identify ultrasound parameters and biochemical markers which can be obtained during the first visit in the emergency room (ER) and that allow a quick risk stratification of patients with sepsis. The rationale of this study is to improve early identification of septic patients who are at risk of rapid deterioration in the course of their permanence in the ER and the hospital wards in general. The investigators selected a number of clinical, laboratory and bedside ultrasound parameters which have been previously shown to be correlated with mortality in sepsis, and will seek to identify which among these parameters best correlates with prognosis when acquired in the very first minutes of a patient's arrival in the ER. The objective would be to analyse these parameters and eventually to propose a new early sepsis score which might help the emergency physician to better tailor its efforts and clinical resources to the most sick patients.
Constipation is a frequently encountered problem in childhood, with a prevalence ranging between 1 and 30%. Several studies have proposed pelvic ultrasound, (simple, non-invasive and reproducible) both to define the presence of megarectum, and to follow the answer to treatment, but the real utility remains to be defined, especially in the follow-up.The primary aim of the study is to evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.
The aim of this trial is to assess the efficacy and efficiency of the national and the research sonographic screening protocols for fetal growth disorders. In particular, in Italy at the moment we have two different national screening protocols: the traditional one providing an early third trimester scan at 28-32 weeks'gestation, and a more recent one, according to the new LEA (livelli essenziali di assistenza), providing a growth scan during the third trimester only if there is a clinical indication. Both these national protocols will be compared to a research protocol providing a late third trimester scan between 35 and 37 weeks'gestation in terms of sensibility and specificity.
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
This phase III, prospective, randomized, double-blind, placebo-controlled trial will primarily aim to compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits, one-week apart) in non-dialysis patients with CKD stage IIIB to V receiving best available conservative therapy, including RAAS inhibition with ACE inhibitors and/or ARBs and/or aldosterone antagonists. Patients are expected to be included during an 18-month recruitment period. All randomized patients will be maintained on active follow-up for 12 months. At 12 months, a final visit will be performed for all patients who complete the follow-up period. During this final visit, all the parameters evaluated at baseline will be reassessed and the study treatment will be discontinued. Whenever feasible, a final visit will be planned within one month also for those patients who prematurely discontinue the treatment period for any intercurrent reason (adverse event, consent withdrawal and other). After the final visit the patient will be discharged from the study and will be referred to his nephrologist with the suggestion to check serum potassium levels within three days.
The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.
We will study the effects of intensive rehabilitation in PD on plasticity with a multimodal approach. We will define first, whether exercise in PD restores the potentiation of the motor cortex to normal levels with both 5 Hz-rTMS PAS and beta modulation and whether such improvements are accompanied by structural changes studied with diffusion MRI tractography and network analysis (Aim 1). With the study of muscle synergies and spatiotemporal organization of the spinal motoneuronal output during gait and reaching movements we will define the presence of functional changes in spinal cord mechanisms and connectivity and whether such changes are global or involve selective districts (Aim 2). Finally, we will study post-exercise changes in sleep pattern, as sleep is impaired in PD and plays a crucial role in the definition of plasticity-related phenomena (Aim 3). This project will generate breakthrough data on the mechanisms of exercise, novel biomarkers to monitor efficacy of treatments and thus, possibly leading to better restorative, disease-modifying and symptomatic therapies for PD.
The purpose of the study is to evaluate the ability of placental angiogenesis markers to predict the risk of PE in pregnancy in women with primary APS. To construct reference intervals of placental angiogenesis markers specific to women affected by primary APS in pregnancy by measuring the levels of sFlt-1and PlGF in serum maternal serum and their sFlt-1/PlGF ratio during the trimesters of gestation (I TM, II TM and III TM). For this aim the study will involve recruiting two groups of subjects, one will be cases and one will be controls.
Intestinal Celiac Disease (CD)-antibodies have been described as the best marker to reveal progression toward villous atrophy and could become the diagnostic marker to make prompt diagnosis in the wide clinical spectrum of CD reducing the delay in diagnosis and treatment. The introduction of either anti-endomysial antibodies (EMA) assay or rapid anti-Transglutaminase 2 (TG2) test on supernatant of mechanically lysed biopsy samples in the clinical practice would improve the diagnosis of CD, especially in clinically challenging scenarios. The availability of an accurate test for identifying intestinal CD-antibodies that do not need the culture of intestinal biopsy is less expensive, less time consuming and easier to perform would facilitate the implementation of such technology outside research laboratories, and enable the diagnosis of CD at the end of Gastrointestinal Endoscopy (GIE).