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 use of serum biomarkers in the setting of the emergency department (ED) has been well characterized over the years as an adjunctive tool for the clinician in the setting of complex decision making. In this regard, the serum dosage of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1) has been evaluated in a series of successful multicenter prospective studies as a potentially useful marker of, respectively, glial and neuronal damage in the setting of mild traumatic brain injury (mTBI), which is defined as a brain injury (concussion) secondary to trauma with a GCS (Glasgow coma scale) score of 13-15. It seems that both markers are detectable in serum less than 1 hour after the traumatic event, with highest levels appearing at around 2 hours, and are capable of distinguishing between patients with traumatic brain injury from those without acute brain injury after trauma. Furthermore, they seem to possess a high negative predictive value for detection of intracranial injuries at head CT-scan as well as the need of neurosurgical intervention after head trauma. Mild traumatic brain injury is one of the most frequent chief-complaints for patients presenting to emergency departments worldwide. At present, head CT scan is the gold standard diagnostic test for the identification of potentially life-threatening intra-cranial injuries. Although effective in the identification of serious lesions which might require neurosurgical intervention or in-hospital prolonged observation, the extensive use of head CT scan in mTBI has been questioned due to the potential risks related to radiation exposure, as well as unnecessary deployment of ED resources and increased costs, considering that the prevalence of CT-detected intra-cranial injury in mTBI is around 5-10%. For this reason, a number of international clinical guidelines suggest several Clinical Decision Rules (CDR) and algorithms to guide the clinician in the correct management of these patients, in particular in the difficult feat of identifying those patients who don't need to perform neuroradiological evaluation (CT scan or MRI) in the setting of the ED, without the risk to overlook potentially fatal brain injuries. The adjunctive role of these biomarkers has been well characterized in the setting of mTBI. It seems they correlate well with neurological damage as well as with the presence of CT abnormalities, and it seems that they might perform better than clinical evaluation alone. Nonetheless, according to current international guidelines and several systematic reviews and meta-analysis, patients who present with mTBI and risk factors for bleeding and delayed bleeding (such as known coagulopathy, patients on blood thinners or advanced age), need to perform CT scan plus clinical observation or even serial CT scans when the risk of delayed bleeding is considered to be high according to clinical evaluation of the ED physician and according to local standard-of-care and clinical practice. The execution of serial CT scans can be time consuming, expensive for the health-care services, and might pose a significant radiological risk for patients; furthermore, this risk might be unjustified considering that the prevalence of development of late intra-cranial bleeding in patients with risk factors who perform a second head CT scan during observation in the ED is considered to be around 2%. Nonetheless, in this category of patients, clinical observation and the repetition of a second head CT scan is felt to be the safest course of action for patients in order not to overlook potentially fatal injuries. Ideally, a clinical decision algorithm which takes into consideration a serum biomarker with a high negative predictive value for brain injury might aid the clinician to reduce the number of useless CT scans, therefore reducing the observation time in the ED as well as the exposure to ionizing radiations for the patients, while not increasing the number of missed delayed bleedings. At present, the role of GFAP and UCH-L1 in the risk stratification of patients with risk factors for delayed cerebral bleeding after mTBI has not been evaluated yet.
This will be an open-label, prospective, single-centre, randomised, controlled, parallel-group medical device investigation. The investigational plan will include four visits in total at the investigational site. One visit (Visit 2) will consist in the hospitalisation period and will last 3/4 days. Patients will be admitted to hospital in the day preceding the TURBT (Day -1; in case the TURBT is programmed in the morning) or in the day of the TURBT (Day 0; in case the TURBT is programmed in the afternoon) and will stay in the hospital for 3/4 days after the intervention (performed on Day 0). Patients will then be discharged, if considered as appropriate based on Investigator's judgment, following the removal of the catheter and the first clear urination. Patients will be asked to remain in the same geographic area of the investigational site up to the end of study visit.
During a submaximal task, gradual muscle fatigue occurs, which inevitably results in a decline in performance (mechanical failure). Elite athletes are known to employ unconscious compensatory strategies during fatiguing submaximal tasks in an attempt to delay the onset of mechanical failure as long as possible. The purpose of this study was to gain valuable insight into the strategies used by elite swimmers to cope with mechanical failure. Twenty-two swimmers were subjected to a swim test consisting of swimming as long as possible at a predetermined and controlled pace. A light strip positioned at the bottom of the pool allows athletes to get feedback on which gait to keep. The kinematics (stroke rate, stroke length, and efficiency index) and electrical activity of 10 muscle groups were analyzed and compared at the beginning of the test (non-fatiguing conditions), just before the athlete lost the ability to maintain the predetermined pace (pre-mechanical failure), and after the athlete lost the ability to maintain the pace (mechanical failure). It is hypothesized that as fatigue becomes more pronounced and the point of inability to maintain a predetermined speed is approached, increased EMG activity will occur in key muscles while other muscle groups may show more obvious signs of fatigue. In addition, changes in the rhythm and coordination of upper limb movements may occur.
Children have a highly compliant chest wall and atelectasis formation occurs often during pediatric anesthesia. Inhalation induction is commonly performed in pediatric anesthesia but it is still unclear if this can have an effect on the development of atelectasis. Aim of this study is to investigate the impact of inhalation versus intravenous induction on atelectasis formation during anesthesia induction in children. Atelectasis will be evaluated with lung ultrasound before induction and right after induction.
In this interventional, pilot clinical trial investigators will stimulate the dorsolateral prefrontal cortex (DLPFC) in patients with Autism and ADHD. The goal of the study is to improve Cognition and Executive Functions associated with this brain region and, consequently, ameliorate the core symptoms of the disorders. Specifically, the primary purpose is to establish the efficacy, safety, and tolerability of TMS in pediatric patients with ASD and ADHD. Concurrently, the research aims to uncover the impact of TMS on particular biomarkers associated with the development of these disorders and validate the hypothesis suggesting that the BDNF gene polymorphism (Val66Met) could influence an individual's susceptibility to TMS. Participants will be randomized into the active group and placebo group, to guarantee a real assessment of the impact of neurostimulation on the cognitive, behavioral, and biochemical parameters. Participants will be asked to complete a neuropsychological evaluation and a biological sample collection before and after TMS treatment, and 1-month post-treatment completion.
In patients with pancreatic cancer, older age, multiple comorbidities, frailty, malnutrition and poor functional status are common, especially in individuals receiving neoadjuvant chemotherapy. These characteristics represent potentially modifiable risk factors for poor postoperative outcomes. The goal of this clinical randomized controlled trial is to evaluate the extent to which a four-week multimodal prehabilitation program impacts on postoperative morbidity, functional and nutritional status and health-related quality of life in patients with localized pancreatic or periampullary cancer scheduled for curative surgery. In addition, the impact of prehabilitation on circulating sarcopenia and cancer cachexia biomarkers in PDAC patients will be explored. Included patients will be randomized (ratio 1:1) and allocated either to the intervention group (Multimodal Prehabilitation), which will receive prehabilitation, or to the control group, which will receive no prehabilitation.
The masseter muscle is one of the muscles in the lower face used for chewing. Prominence of the masseter muscle can appear as a widened and square lower face shape, which is an aesthetic concern for individuals who prefer a narrower and more ovoid lower face shape. Treatments are available for masseter muscle prominice (MMP), but researchers are looking for new non-surgical treatments. This study will assess adverse events and effectiveness of BOTOX in adult participants with MMP. BOTOX is being investigated for the treatment of MMP. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is 1 in 4 chance that participants will be assigned to placebo. Around 248 adult participants with MMP will be enrolled in the study at approximately 30 sites in Europe. Participants will receive either BOTOX or Placebo administered as 6 intramuscular injections to the masseter on Day 1. Participants who are eligible for retreatment will be given BOTOX on Day 180 and will be followed for up to 6 months. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
The use of lung ultrasound is instrumental in the evaluation of many chest pathologies and its ability to detect pleuro-pulmonary pathology is widely accepted. However, the use of ultrasound to explore the state of the peripheral lung parenchyma, when the organ is still aerated, is a relatively new application. Horizontal and vertical artifacts are separate and distinct artifacts that can be seen during ultrasound examination of the lungs. While the practical role of lung ultrasound artifacts is accepted to detect and monitor many conditions, further research is needed for the physical interpretation of ultrasound artifacts. These artifacts are diagnostic signs, but we don't fully understand their origin. The artifactual information deriving from the surface acoustic interaction, beyond the pleural line, in the ultrasound images of the normally aerated and non-deflated lung, represents the final result of complex interactions of acoustic waves with a specific three-dimensional structure of the biological tissue. Thus, the umbrella term "vertical artifacts" oversimplifies many physical phenomena associated with a pathological pleural plane. There is growing evidence that vertical artifacts are caused by physiological and pathological changes in the superficial lung parenchyma. Therefore, the need emerges to explore the physical phenomena underlying the artifactual ultrasound information deriving from the surface acoustic interaction of ultrasound with the pleuro-pulmonary structures.
Ampullary adenocarcinoma (AAC) is a rare gastrointestinal cancer with varying survival rates, particularly the aggressive pancreatobiliary (PB) subtype. Adjuvant therapy benefits only PB and mixed subtype patients, while prospective studies are required for validation. A study proposes tailored adjuvant treatments (CAPOX for intestinal subtype, FOLFIRINOX for PB and mixed subtypes) based on histopathology to enhance survival, also exploring molecular sub-studies for deeper insights.
Estimation of the incidence of pulmonary embolism in patients presenting to the Emergency Department with hemoptysis.