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.
High-quality respectful care around the time of childbirth is a fundamental aspect of human rights and, according to recent global estimates, could prevent more than 100,000 maternal deaths and 1.3 million neonatal deaths annually. Despite some maternal and newborn health indicators in high-income countries being better in comparison to low-income and middle-income countries, existing evidence shows that improvements are needed in the quality of care provided to women and newborns in every country. In 2016, the World Health Organization (WHO) developed a framework and a list of Standards for improving the quality of maternal and newborn care (QMNC). The WHO Standards define a set of 318 Quality Measures, divided into three key domains - experience of care, provision of care and availability of resources - which can be used to assess the QMNC at facility level. The ongoing project, named IMAgiNE (Improving MAternal Newborn carE), includes all maternities hospitals of the FVG Region and aimed at improving the quality of maternal and neonatal health care in the region. Quality of care is assessed using two complementary perspectives (women and health workers), with two validated questionnaires including about 100 quality measures based on the WHO Standards. It provides data on both the baseline assessment and the Quality Improvement component (progresses made).
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin (SGN-B6A), which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
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.
This study aims to assess the safety and tolerability of the individual highest tolerated zamicastat doses, achieved in the study BIA-51058-201, during long-term treatment in Pulmonary Arterial Hypertension (PAH) disease.
This is a prospective, observational cohort study to evaluate the clinical impact of novel Monoclonal AntiBodies (MAB) in B-cell Non-Hodgkin Lymphoma (NHL) in Italian clinical practice.
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.