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 goal of this observational study is to compare Nociception Coma Scale-Revised Recorded (NCS-R) scores obtained with the standard pressure on fingernail bed (standard stimulus, SS) versus other personalized painful stimuli (PS), in non-communicative patients with disorders of consciousness (DoC), as indicated by professionals and caregivers involved in their care and rehabilitation. The study aims also to establish possible correlations between NCS-R and Coma Recovery Scale-Revised (CRS-R.) The main question : an integrated patient-centered approach for assessment of the physical pain, in which clinical measures and behavioral observations will be integrated, to understand and manage the pain intensity, may improve treatment and rehabilitation outcome. Specifically, a new version of NCS-R, adapted with PS, may produce more intentional and specific responses to pain-inducing maneuvers. Investigating pain perception in non-communicative patients, through recognition of a personalized source of nociception and pain, may avoid non specific, useless and harmful noxious tests (as with standard pain scales) and may provide tools for revealing nociception even in the lack of any response to standard clinical evaluation. Question 1: the superiority of personalized painful stimulus a standard painful stimulation in nin communicative patients. Question 2: the parallel recovery of painful stimuli responsiveness and consciousness Participants will Responsiveness and pain perception will be assessed respectively with the CRS-R and the NCS-R. Pain responses will be assessed by means of standard stimulus (NCS-R-SS, as used in the CRS-R) and personalized stimulation (NCS-R-PS), at admission and discharge. CRS-R will be administered within the first month after admission, at least 5 times in different days, choosing the highest score as reference and repeated during recovery of consciousness or discharge. After informed consent by patient's legal representative or the primary caregiver, for the purpose of the study, caregivers (including relatives, nurses, therapists, physicians) will be asked to record all manoeuvres they feel are associated with potential pain, with a window of observation of the rehabilitation and nursing staff of around one week to identify the personalized painful stimulus (about the second week after admission at the rehabilitation ward). Amongst them, the manoeuvres that consistently over time induced the most motor/behaviour responses suggestive of pain perception, reported at least by 2 members of the rehabilitation staff or by one of them and one caregiver, will be chosen as the personalized stimulus (PS). NCS-R with standard stimulus (NCS-R-SS) and with personalized stimulus (NCS-R-PS), will be recorded within 30 days after admission, alternating the order of the 2 painful stimulations; CRS-R will be recorded accordingly, in parallel to NCS-R-SS and NCS-R-PS and will be blindly recorded, at the same time, by two different rehabilitation staff members, to assess inter-rater reliability, whereas two of them will repeat both NCS-R_SS and NCS-R-PS during the same week to assess intra-rater reliability of both NCS-R-SS and NCS-R-PS, with an interval of at least 6 hours from the last pain killer or anti-spastic drugs administration, including GABAergic, anti-inflammatory drugs or opiates. Both CRS-R and NCS-R (SS and PS) will be repeated 1 month and 3 months after the first assessment with the same procedures of the first time.
The aim of the study will be to evaluate the impact of consumption of meat and dairy products from extensive or intensive farming on apparently healthy individuals aged between 45 and 65 years, a stage of life associated with reduced metabolic flexibility and changes in lipid metabolism. The study will analyze: 1. The transcription factor PPAR-α determined by the gene expression of PPAR-α in white blood cells, variations in circulating fatty acid metabolism, and the endocannabinoid system determined by circulating analysis of N-acylethanolamine (NAE), and 2-monoacylglycerols (2-MG); 2. Metabolic flexibility, determined by indirect calorimetry in fasting condition during an incremental exercise; 3. Body composition, determined by bioimpedance analysis, waist circumference, and waist-to-hip ratio.
The postural observation of the patient has an important role for the evaluation and monitoring of orthopedic and neurological degenerative pathologies. The study of the effects of rehabilitation in the treatment of postural alterations depends on the validity, sensitivity and specificity of the tool used. The radiographic evaluation of the spine in the standard anteroposterior and lateral projections is the gold standard and provides a standardized and objective measure of the dysmorphisms and paramorphisms of the spine, although it requires exposure to X-rays and with costs of the method especially in the need to repeat the radiological examination in time. Non-radiological tools for postural assessment have been proposed in the literature, with uncertain judgments by the various authors regarding their validity and reliability, due to the heterogeneity and poor quality of the studies in this regard. The aim of this study is to evaluate the effectiveness of a new posture analysis methodology (BHOHB SPINAL-METER ® and CervicalMeter®) in measuring spine dysmorphisms and paramorphisms in adult patients affected by orthopedic and neurological degenerative pathologies, who carry out rehabilitation at the Policlinico Gemelli Foundation (FPG) Hospitalization and Rehabilitation Services clinic. In particular, the correspondence of radiological and clinical data with the reports obtained from the "BHOHB SPINAL-METER ® and CervicalMeter®" will be considered and the relationship between the data obtained with the two methods and the characteristics of pain, disability, balance and quality of life will be observed of patients suffering from orthopedic and neurological disease with dysmorphisms and paramorphisms of the spine, belonging to the rehabilitation clinic who agree to participate in the study.
The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. In fact, a reduction in Nitric Oxide (NO) production by the endothelium, an increase in systemic vascular resistance and an increased risk of cerebral and renal hypoperfusion have been observed and can result in potential organ damage. Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity. Its incidence varies according to different definitions, but can reach 30%. In some series, 1-5% of patients require renal replacement therapy in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine are associated with worsening prognosis and the risk of chronic kidney disease. The pathophysiology of AKI in cardiac surgery is complex and still partly unknown.Recently a technique has been described that allows to measure the blood velocity in the right renal artery and in the superior mesenteric artery using the transesophageal echocardiogram (TEE); this technique allows to view these arteries and measure the speed of the blood with good precision because the insonation angle (ie the angle formed by the ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this methodology allows you to monitor blood velocity in the right renal artery and superior mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which the blood velocity values in the renal arteries during cardiac surgery were used to calculate the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. At present, therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little studied during cardiopulmonary by-pass (CPB) and has never been evaluated during CPB with continuous flow; in particular, the possible variation in blood velocity measured during CPB compared to the baseline values measured before extracorporeal circulation and its correlation with the onset of postoperative renal failure is not known.
Evaluation of the safety and performance of the Navitor TAVI System in a Global Study
Juvenile Idiopathic Arthritis (JIA), the most common rheumatologic chronic disease in children, is defined as arthritis persisting for at least 6 weeks with no known cause in a patient under the age of 16. The term JIA is an umbrella that includes very different diseases. The current International League of Associations for Rheumatology (ILAR) classification divides JIA patients into 7 categories based on number of involved joints and time of involvement, presence of systemic symptoms, psoriatic findings and spondyloarthritis. This classification groups together patients with different disease and divides patients with the same disease. In the first case, unifying distinct diseases could lead to undifferentiated therapeutic choices, moving away from the modern concept of therapeutic personalization. In the second case, similarities between paediatric and adult arthritis could not be found. This involves both a loss of collaboration with the adult rheumatologist and the difficulty in accessing possibly effective therapies approved only for adult arthritis. In clinical practice, it is increasingly evident that the number of affected joints and the speed of joint involvement are not useful criteria for defining the type and severity of disease. Joint counts lead to underestimate the importance of joint distribution in the identification of distinct forms of arthritis. A recent study found that patterns of joint involvement represent prognostic features, so grouping patients by joint pattern and degree of localization may help clinicians tailor treatments based on predicted disease trajectories. Another important point to differentiate some forms of arthritis is the presence of enthesitis and tenosynovitis. Sometimes tendon inflammation can be not clinically evident, so ultrasound evaluation is useful to detect it. Musculoskeletal ultrasound (MSUS) has been used worldwide by adult rheumatologist, but it is beginning a useful tool also in patients with JIA. Recent studies underline the important role of MSUS findings to assess disease activity and assist disease classification. In recent years, the need has emerged to replace the ILAR criteria with a new nomenclature based on the disease biology. This approach could help clinicians to choose a personalized therapeutic strategy for patients with arthritis.
Even in high-income countries, quality of pediatric health care has been described as substandard in many settings, resulting in worst health outcomes and increased cost for the health system. Nevertheless, still there is a paucity of studies documenting the quality of care for children in a comprehensive and systematic manner, using international standards, and validated data collection tools. The World Health Organization (WHO) developed three sets standards for improving the quality of maternal newborn and child health care. The aim of this study is to test the use of the WHO Pediatric standards for improving the quality of child hospital care, as summarized by a score of total mean quality score for patients (range 0-100 points).
The goal of this interventional study is to test whether sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce the effects of high dietary sodium intake in patients with type 2 diabetes. Participants will undergo a dietary intervention consisting of a week of high-sodium diet, followed by a week of low-sodium diet. At the end of each week the patients will undergo: - 24-h ambulatory blood pressure measurement; - 24-h urine collection; - bioimpedance analysis for body composition determination; - blood and urine tests. The study will compare patients treated with SGLT2i and patients not treated with SGLT2i to test whether the treatment reduces the effects of high sodium intake on blood pressure, body composition and biochemical variables.
The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment. The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers. The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care. Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care. PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.
This is a Phase 2, multicenter, double-blind, sponsor unblinded, placebo-controlled, single-dose clinical study of CRD-4730 to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CRD-4730 when administered as single oral doses to participants with Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT). The study will have 2 cohorts in which participants with CPVT will participate in a 3-period, randomized 2-sequence study. Each participant will receive 2 different doses of CRD-4730 and 1 dose of matching placebo, with each study drug administered as a single dose.