Clinical trials

The use of ultrasound has been suggested to support the management of labour. According to several studies, ultrasound examination is more accurate and reproducible than clinical examination in diagnosing fetal head position, fetal station, and the prediction of labour arrest. Furthermore, there is growing evidence that ultrasound in labour may predict the outcome of instrumental vaginal delivery: a support to assess when an operative delivery is necessary. Ultrasound in labour can be performed using a transabdominal approach, mainly to determine head and spine position, or a transperineal approach, to assess head station and the situation at low stations. Several sonographic parameters have been proposed to evaluate the head station. Furthermore, all ultrasound parameters studied so far, have always been measured with the woman in a supine position. While the biomechanics of childbirth with its mechanisms (known as nutation, counter-nutation of the pelvis, and the coccyx retropulsion) together with maternal movement, promote fetal rotation and the adaptation of its diameters with those of the maternal pelvis, allowing to gain more room for the fetal descent. Moreover, in most of the studies on intrapartum ultrasound, the mobility of the pelvis has not been mentioned. The contracted pelvis is the absence of mobility that leads to fetal-pelvic disproportion, arrest of labour, and operative delivery. Maternal pelvis biomechanics studies by high technological techniques have shown that maternal shifting positions during pregnancy and childbirth can create more room in the pelvis for safe delivery. The external and internal pelvic diameters are closely related. For this reason, the evaluation of the mobility of the pelvis appears to be a necessary element to understand the ability of that pelvis to widen its diameters for fetal descent. The aim of the study is to measure the variation of AoP, HPD in the supine position and in kneeling-squat position in the same woman and the cut-offs of the new ultrasound parameters and predictive capacity for vaginal birth.

Remifentanil is commonly used as an opioid during general anesthesia. In recent years, several pharmacokinetic/pharmacodynamic (PK/PD) models for target-controlled infusion (TCI) have been developed, with the Eleveld model being one of the most recent and designed for broad applicability. The aim of this study is to compare the Eleveld TCI model with the routinely used Minto model, in order to evaluate potential differences in the predicted effect-site concentrations (CeR) required to achieve equivalent analgesia levels, as measured by qNOX (CONOX monitor) and the Analgesia Nociception Index (ANI). Post-Tetanic Count (PTC) was also assessed during the maintenance phase to investigate possible differences in nociceptive index responses between the two TCI models.

Implicit memory formation and learning during general anaesthesia is a still debated question and no anesthetic regimen (ie intravenous anaesthesia vs inhalatory one) nor analgesic regimen (i.e. low or high opioids usage) has been identified for prevention. With this study the investigators aim to investigate if, during Total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) different concentrations of Propofol at loss of responsiveness, maintenance and return of responsiveness can have a role in implicit memory formation.

The goal of this clinical trial is to learn if a dietary supplement called ButyMixx can help people with ulcerative colitis in remission feel better and keep their intestines less inflamed. ButyMixx contains: * Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation. * A "beneficial" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota. It will also learn about the safety of dietary supplement. The main questions it aims to answer are: * Does ButyMixx after 2 months of supplementation * Symptoms improve, * Quality of life improves, * Intestinal inflammation decreases , * The gut microbiota becomes more "balanced" * What medical problems do participants have when taking ButyMixx ? Participants will: * Take 2 sachets of ButyMixx per day for 8 weeks * Before starting and at the end of the 8 weeks: * Provide a stool sample * Complete a quality-of-life questionnaire * Be assessed by a doctor using a symptom score

Postpartum Depression (PPD) is defined as the development of depression at any time during the first year after childbirth¹. Its prevalence ranges from 15% to 20%. It can manifest with symptoms such as depressed mood, loss of interest and energy, insomnia, anxiety, and may even lead to suicidal ideation. The consequences are numerous, both physical and psychological, with long-term repercussions on the mother-infant bond, family dysfunction, and the development of emotional and cognitive disorders in children. The etiology of PPD is multifactorial, but numerous recent studies have focused on the role of labor pain and its management with labor analgesia techniques. The aim of the present study is therefore to assess whether there is a difference in the incidence of PPD between parturients whose expectations regarding labor analgesia were met ('expectations met' group) versus those whose expectations were unmet.

Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velcoity).

This study is comparing two types of pain relief techniques-TAP block and ESP block-for women having an elective cesarean section. Both techniques involve injecting local anesthetic under ultrasound guidance to numb nerves and reduce pain after surgery. The TAP block mainly relieves pain in the abdominal wall, while the ESP block may reduce both abdominal wall and deeper, organ-related pain. The main goal is to see if there's a difference in pain at rest six hours after surgery. The study will also look at pain at later time points, the amount of opioid medication needed, how quickly women can walk, and when they start breastfeeding. A total of 156 women will be randomly assigned to receive one of the two blocks after standard spinal anesthesia. Pain will be measured using a simple 0-10 scale at 6, 12, and 24 hours, both at rest and during movement. The study follows strict ethical rules, ensures patient privacy, and all results-whether positive or negative-will be shared to help improve pain management after cesarean delivery.

Prrospective, multi-center, randomized controlled trial of a brief, transdiagnostic, guided self-help intervention (Self-Help Plus) for university students who experience significant distress and are behind on their coursework. The intervention will be tested in terms of efficacy and feasibility for outcomes related to distress, anxiety, depression and well-being, assessed immediately after the intervention and at 3-months follow-up.

The goal of this quasi-experimental study is to learn if a nurse-led care program can help prevent or manage frailty in older adults living in the community. The study focuses on people aged 65 years and older who have at least one chronic condition, show early signs of frailty, and have difficulty with self-care. The main questions it aims to answer are: * Does the nurse-led NUR-FRAIL program improve participants' ability to care for their chronic conditions after six months? * Does the program improve quality of life and reduce health-related difficulties? * Does the program lower emergency department visits and hospital stays over one year? Researchers will compare participants who receive the NUR-FRAIL program with participants who receive usual care to see if the program leads to better self-care, better quality of life, and less use of hospital services. Participants will: * Meet with a Family and Community Nurse for health and frailty assessments at the start of the study, after three months, and after six months * Complete short questionnaires about self-care, daily functioning, and quality of life * Receive either usual care or a three-month nurse-led program that includes personalized education, goal setting, lifestyle advice, and support for managing chronic conditions * Allow researchers to collect information about emergency visits and hospital stays for up to twelve months Some participants in the nurse-led group will also be invited to take part in an interview to share their experience with the program.

The aim of this project is to test the feasibility, acceptability and clinical impact of a mobile app-based intervention (FoodTraining) to strengthen food-related inhibitory control over 4 weeks, in a sample of people with eating or weight disorders (i.e. obesity, binge-eating disorder (BED), or bulimia nervosa (BN)) receiving standard outpatient treatment (i.e., treatment as usual (TAU) encompassing guided self-help or psychotherapy, pharmacological therapy or diet). The training will be offered in addition to TAU (experimental group) and compared to TAU alone (control group). Participants will complete questionnaires to measure eating behaviour, eating disorder psychopathology, symptoms of anxiety, depression and stress, social functioning and quality of life at baseline, 4 and 8 weeks. They will also complete momentary assessments using a mobile application (FoodTracker) to report on food intake along with related thoughts, emotions, and behaviours and will wear small, non-invasive sensors to track real-time fluctuations in glucose levels for 15 days. Participants will also perform a food-related go-no go task and a food-related temporal discounting task at baseline, 4 and 8 weeks. Finally, this study will pilot the use of a semi-structured interview to characterise the history of weight, the appetite system, eating-related habits in the family and learning of eating behaviours and attitudes in people with eating or weight disorders.

Dexmedetomidine Target Controlled infusion (TCI, Dyck model) effects on Neuromonitoring during Total Intravenous Anesthesia (TIVA) with Propofol and Remifentanil TCI (Eleveld model) has not been investigate yet. Authors aim to investigate its effect on Patient State index (PSi), the power spectrum EEG, the Analgesia Nociception Index (ANI) and pupillometry values during maintenance during TIVA-TCI with Propofol, Remifentanil and Dexmedetomidine.

The goal of this prospective observational study is to compare two different methods of monitoring muscle relaxation during anesthesia - acceleromyography (AMG) and electromyography (EMG) - in people with obesity who are having bariatric surgery with general anesthesia and the muscle relaxant rocuronium. The main question is: Which method is more accurate and precise in measuring the Train-of-Four (TOF) ratio during surgery? As part of this comparison, researchers will also note how quickly each method detects recovery of muscle function after the reversal drug sugammadex. Participants will: * Receive standard anesthesia care for bariatric surgery, including rocuronium to relax the muscles. * Have two small monitoring devices applied, one to each hand: AMG on one hand, EMG on the other. * Be monitored for muscle function during surgery and after receiving sugammadex to reverse the muscle relaxation. Researchers will also record how easy each device is to use and whether participants have any breathing problems after surgery.

The RightAIDE study is a prospective, multicenter, observational registry designed to evaluate the real-world application of the HeartInsight™ algorithm for predicting acute heart failure (HF) events in patients implanted with a Biotronik ICD or CRT-D device with atrial sensing and Home Monitoring capability. Heart failure is a growing public health issue with high morbidity, mortality, and healthcare costs. HeartInsight, derived and validated in the SELENE HF study, integrates temporal trends of seven physiological variables monitored by the implanted device to provide early warnings of impending acute decompensation, with a median lead time of 42 days. This study aims to collect data on the implementation of a standardized workflow for interpreting and responding to HeartInsight alerts in routine clinical practice. Approximately 100 patients across 14 centers in Italy will be enrolled and followed for 12 months. The primary endpoint is the proportion of HeartInsight alerts considered "actionable," meaning they trigger at least one predefined clinical action (e.g., device reprogramming, therapy optimization, unscheduled visits, or hospital admission). Secondary endpoints include alert frequency, cumulative alert duration, number of patient interviews performed, hospitalizations during and outside alert periods, and the proportion of patients successfully using the HeartInsight Patient App. Data will be collected via electronic case report forms (eCRFs), analyzed descriptively, and monitored for quality. The study will generate insights into integrating HeartInsight-based predictive monitoring into clinical workflows to potentially improve patient management and outcomes.

This study aims to investigate pediatric intensive care providers' knowledge, perceptions, and experiences with Law 219/2017 by means of a national multicentric non-interventional cross-sectional study.

Epidural analgesia is the gold standard for labor pain management, widely recommended by the WHO and included in Italy's essential levels of care (LEA) since 2017. Despite its clinical benefits and high maternal satisfaction, the procedure remains technically challenging, particularly for anesthesia residents. In our institution, around 40% of laboring women request epidural analgesia. Successful epidural placement requires mastering a complex skillset. Recent studies highlight that simulation-based training significantly enhances learning for novice practitioners. This single-center, prospective, randomized controlled trial aims to evaluate whether a pre-rotation simulator-based training improves the success rate of epidural catheter placement among anesthesia residents. Participants will be randomly assigned to either the intervention group (simulation training plus anatomy lecture) or the control group (standard in vivo training only). The primary outcome is the number of successful catheter placements (defined as completed procedure without tutor intervention). Secondary outcomes include procedure time, complication rates, and satisfaction scores from the residents. The study will involve anesthesia residents in their 4th or 5th year rotating in the labor ward of the Azienda Ospedaliera di Padova. A sample size of 86 participants (43 per group) is required, and data collection will occur over three years.

This is a prospective observational study conducted at the University Hospital of Padua. The goal is to identify ultrasound markers that can help predict whether placing an epidural catheter during labor will be difficult. Pregnant women who request epidural analgesia will undergo a quick ultrasound scan of their lower back before the procedure. The study will collect information such as age, weight, height, and spinal anatomy, as well as ultrasound measurements. This information will be compared with how easy or difficult it was to place the epidural. The study does not involve any experimental treatment and uses standard care procedures already in place. There are no additional risks or costs for participants.

This study evaluates the impact of a psychological group intervention aimed at promoting well-being and social connectedness among university students. The intervention is part of the UNIST-HEALTH (PRO-BEN) initiative and targets students enrolled at the University of Padua. Participants will be randomly assigned to either an intervention group or a waitlist control group. The intervention consists of six weekly group sessions focused on psychoeducation and experiential activities designed to enhance the quality of social relationships, reduce loneliness, and improve psychological well-being. Assessments will be conducted at baseline, post-intervention, and at a four-week follow-up.

Anorexia Nervosa is a psychiatric disorder characterized by high rates of chronicity, significant societal costs, and one of the highest mortality rates among psychiatric illnesses. Despite therapeutic advances, treatment outcomes remain poor, with high relapse rates and full recovery achieved in only 50% of cases. Recent cognitive, behavioral, and neuroimaging studies suggest that Anorexia Nervosa may involve dysfunction in a posterior parietal network responsible for multisensory integration. This network plays a pivotal role in bodily self-representation and the modulation of environment-body interactions, and may therefore be directly implicated in two core symptoms of the disorder: distorted body image representation and dietary restriction. Given these insights, Transcranial Magnetic Stimulation (TMS) - an established neuromodulation technique with proven efficacy in various psychiatric disorders - emerges as a promising investigational intervention. The aim of this study is to evaluate the feasibility and therapeutic efficacy of a protocol of intermittent Theta Burst Stimulation (iTBS) targeting the right posterior parietal lobe in patients with Anorexia Nervosa. The active iTBS protocol will be compared to a sham (placebo) stimulation as a control condition.

This pilot study investigates the feasibility of a prospective longitudinal observational approach to identify variables influencing home nursing care time. Conducted within the ULSS 6 Euganea health district in Italy, the study will analyze nursing care and travel time across approximately 350 home visits involving up to 200 voluntarily enrolled adult patients. Data will be collected anonymously by nurses using a digital tool (REDCap), capturing a predefined core set of variables previously selected via the Delphi method. The study aims to understand the association between individual, contextual, and organizational variables and the time required for home nursing interventions. Results will inform better planning and resource allocation for home care services.

Protective ventilatory strategy should be applied to reduce ventilator-induced lung injury (VILI) after Lung Transplantation (LTx) or in case of acute respiratory failure requiring invasive mechanical ventilation. Neurally Adjusted Ventilatory Assist (NAVA) is an assisted ventilation mode in which respiratory support is coordinated by the electrical activity of the diaphragm (EAdi). Aim of the study is to assess the physiological relationship between neural respiratory drive, as assessed by EAdi, and tidal volume, driving pressure, and mechanical power, at different levels of ventilatory assist, in the absence of pulmonary vagal afferent feedback or during acute respiratory failure. Additional parameters will be collected: Pmus, Pocc, transpulmonary pressure etc.

Background: Venous ulcers are skin lesions caused by impaired blood circulation. In Western countries, about 1% of the population is affected, and approximately 3% those over 80 years old. Venous leg ulcers tend to become chronic; a lesion is defined as chronic when it does not progress towards spontaneous healing. The treatment of these lesions inevitably involves long healing times, which results in increased healthcare costs. Moreover, venous leg ulcers have recurrence rates ranging from 18% to 28%. For this reason, it is important to support patients affected by or at risk of venous ulcers during their healing process or for prevention. Objectives: The primary objective of the study is to assess the superiority of the educational interventions to the standard therapeutic education, in improving the patient's/caregiver's self-efficacy, after 4 weeks, 3, 6 and 12 months from the educational intervention begin. The secondary objectives are to clinically assess the impact of the educational intervention in decreasing healing time and recurrence rates and in patients' well-being after 12 months of follow-up. Additionally, the Well-being of Wounds Inventory (WOW-I) questionnaire will be validated in its Italian version. Methods: the study is a two arm moncentric randomized-controlled trial. The participants will be randomly assigned into two groups. The control group will receive an educational intervention through a pamphlet, which represents the standard education received in the outpatient clinics involved in the study. The intervention group instead will receive an experimental educational intervention through video played specifically for this study. The socio-demografic, health and ulcer related factors will be collected and the questionnaires: venous leg ulcer knowledge (VLUK), Venous Leg Ulcer Self-Efficacy Tool (VeLUSET) and Well-being Of Wounds Inventory (WOW I) will be administered to the patients during the outpatient clinic visit, before the treatment and after 4 weeks, 3 and 6 months after the intervention. The study also includes a telephonic follow up at 12 months from the start carried out to assess if the patient's venous ulcer has healed or recurred.

The goal of this clinical trial is to learn if the regional anesthesia technique "TAP block" provide more analgesia when performed before or after the surgery. The main questions it aims to answer are: Does preoperative TAP block provide greater analgesia than postoperative TAP block? Patients receiving preoperative TAP block will have less pain and take less painkillers than patients receiving postoperative TAP block? Participants will: Receive preoperative or postoperative TAP block They will be asked about their pain levels during the hospital stay.

Spinal surgery is often burdened by perioperative pain and its treatment presently represents a challenge for anesthetists. An inadequate intra and postoperative analgesic therapy leads to a delay in the mobilization of the patients, prolonged hospital stay and thromboembolic complications, as well as the onset of chronic pain syndromes . Effective pain treatment can help improve surgical outcome for patients undergoing spinal surgery. From the pathophysiological point of view pain in vertebral surgery can originate from different anatomical structures: vertebrae, discs, ligaments, dura mater, facet joints, muscles and skin-subcutis. The terminal innervation of these tissues originate from the dorsal branches of the spinal nerves, and this represents a target a multimodal approach to perioperative analgesia in vertebral surgery. Systemically administered drugs such as NSAIDs, opioids, ketamine, intravenous lidocaine could benefit from the addition of locoregional therapies such as neuraxial blocks (anesthesia peridural or subarachnoid) or as shown more recently by other anesthesia techniques locoregional ultrasound-guided In recent years the anesthesiological interest has focused on the Erector Spinae Plane Block (ESPB). First described by Forero et al, it is a paraspinal interfascial block targeting the dorsal and ventral branches of the spinal nerves just after their emergence from the spinal cord. In the ultrasound-guided technique the local anesthetic is injected between the deep fascia of the muscle itself and the transverse processes of the vertebrae at the level interested. The aim of this study is to evaluate the efficacy of ESPB when compared to wound infiltration in patients undergoing laminectomy

A European-wide cross-sectional non-interventional study, initiated by a pilot study in Italy, will be conducted. The first phase of the pilot study is a 6-step translation, adaptation, and validation of the extended version of the Spiritual Needs Questionnaire (SpNQ-EV) and the Interpretation of Illness Questionnaire (IIQ) adopting the methodology \[3\] described in figure 1. To ensure they are both valid and user-friendly, the Thinking Out Loud (TOL) technique (think-aloud method) will pre-test their self-administration and provide fine tuning of the secondary objectives of the study. TOL involves participants verbalizing their thoughts while completing the questionnaires, allowing to capture real-time insights into their understanding, interpretation, and potential challenges with questionnaires' items. The second phase will consist of an anonymous e-survey consisting of the six questionnaires described in table 1 including the translated and validated SPNQ-EV and IIQ developed in phase 1. The European study will employ a multilingual anonymous e-survey developed to ensure accessibility in participants' native languages, eventually preceded by country-based pilot studies. Eligible participants include adolescents and adults with IBD, as well as their caregivers, recruited via nurses and patient associations.

Nature exposure has been found to be particularly beneficial for body image, as recent studies have identified a positive association between time spent in nature and positive body image. Positive body image, defined as the ability to accept and respect one's body, has been linked to greater life satisfaction and engagement in healthy behaviors. Conversely, negative body image is recognized as a public health concern due to its detrimental effects on both physical and mental health. It has been associated with symptoms of Body Image Disorders (BIDs), including Eating Disorders (EDs) and Body Dysmorphic Disorder (BDD). The Nature for Body Image (NBI) project aimed to examine the impact of a structured nature exposure intervention on improving body image among young women aged 18-35 years.