Clinical trials

Hypertensive disorders of pregnancy frequently fail to resolve at delivery. A substantial proportion of women remain hypertensive at the six-week postnatal review, postpartum eclampsia occurs days to weeks after birth, and a minority show persisting renal dysfunction. Attendance at postnatal follow-up is nonetheless poor and specialist resources are limited, so a simple bedside test that identified the women whose cardiovascular recovery is incomplete would allow surveillance to be targeted. Ophthalmic artery Doppler is non-invasive, takes about five minutes and requires only a linear transducer already present in obstetric units. Its antenatal performance is well characterised, but a systematic review by this group (PROSPERO CRD420261488689) identified only three studies in thirty years addressing the postpartum period, two of which included a normotensive comparator, totalling 131 women. None reported a threshold or any measure of diagnostic accuracy, and none recorded antihypertensive treatment at the time of scanning. This prospective cohort study will measure ophthalmic artery Doppler indices at four timepoints between delivery and three months in women with hypertensive disorders of pregnancy and in normotensive controls, and will determine whether the peak systolic velocity ratio measured 24 to 48 hours after delivery predicts persistent hypertension at the six-week postnatal review.

Pregnancy and vaginal birth are the main causes of pelvic floor disorders such as urinary incontinence and pelvic organ prolapse. The levator hiatus - the opening in the pelvic floor muscles through which the baby passes - can be measured on three-dimensional transperineal ultrasound at rest, during pelvic floor contraction and during a Valsalva manoeuvre. Its size and its ability to stretch have been related to how long labour lasts and to how the baby is eventually born, but the evidence comes mostly from women in spontaneous labour, in whom the exact time labour began cannot be established. Women having their labour induced offer a better model, because the time each stage of labour begins is documented. Recently, automated software has made the measurement of the levator hiatus fast and reproducible, which makes it realistic to use in everyday practice. This prospective observational study will enrol 140 women with a singleton pregnancy at 36 weeks or more who are scheduled for induction of labour. Before induction begins, each woman will have a transperineal ultrasound scan of the pelvic floor at rest, on maximum contraction and on maximum Valsalva. The scan does not involve any vaginal probe, radiation or injection, and takes about 15 minutes. The times of each phase of labour, the way the baby is born and the condition of the perineum after birth will be recorded prospectively from the clinical record. The scan will be repeated before hospital discharge and about one month after birth, together with validated pelvic floor symptom questionnaires. The main question is whether the area of the levator hiatus measured on Valsalva before induction is related to the duration of the active, pushing phase of the second stage of labour. The study will also examine the duration of the first stage, the mode of delivery, and how the pelvic floor changes in the first month after an induced birth. Study procedures do not influence clinical care in any way: induction and labour are managed according to standard departmental protocols, and the research ultrasound results are not disclosed to the clinical team.

The goal of this clinical trial is to evaluate whether daily probiotic supplementation with Bifidobacterium bifidum (Bifipral® drops) can reduce crying time in formula-fed infants aged 5 months or younger diagnosed with infant colic (according to Rome IV criteria), with or without concomitant atopic dermatitis. The main questions it aims to answer are: * Does daily administration of B. bifidum for 8 weeks achieve at least a 50% reduction in average daily crying duration compared to placebo? * Does B. bifidum supplementation improve secondary outcomes, including crying frequency, sleep quality, bowel movement frequency, stool consistency, fecal microbiota composition, short-chain fatty acid (SCFA) levels, and SCORAD score in infants with atopic dermatitis? Researchers will compare formula-fed infants receiving Bifipral® drops (containing B. bifidum strains BFP19® and BFP29®) to a comparison group receiving an indistinguishable placebo to see if the probiotic safely improves colic symptoms and gut microbiota balance. Participants will be asked to: * Complete a 7-day observational run-in period to confirm eligibility and record baseline symptoms in a daily diary. * Administer 5 drops daily of the study product (probiotic or placebo) for 8 weeks. * Complete daily diaries tracking crying duration/frequency, sleep parameters, and bowel habits. * Attend 3 clinical visits (Baseline, Week 8, and a Safety Follow-up 2-4 weeks post-treatment). * Provide fecal samples at Baseline (Visit 1) and Week 8 (Visit 2) for microbiota profiling and SCFA analysis.

This study investigates whether early post-surgical healing (1-2 weeks) affects the 12-month clinical and radiographic success of periodontal regenerative therapy, and identifies patient-related, site-specific, and technique-related factors associated with optimal early wound healing, in patients with Stage III-IV periodontitis.

The goal of this clinical trial is to find out if a new supplement called Normast® 3 can help reduce nerve pain and improve nerve function in adults with diabetic polyneuropathy (DPN). DPN is a common complication of diabetes that damages nerves, often causing burning, tingling, or stabbing pain, as well as problems with the autonomic nervous system, which controls things like sweating and heart rate. The main questions this study aims to answer are: Does taking Normast® 3 lower daily pain levels after 12 weeks of treatment? Does it improve the function of small nerve fibers and the autonomic nervous system compared with a placebo (a look-alike tablet with no active ingredients)? Study design This is a randomized, double-blind, placebo-controlled clinical trial. This means participants are randomly assigned to receive either Normast® 3 or placebo, and neither participants nor researchers will know who is receiving which treatment until the study ends. Who can take part About 40 adults aged 18 to 80 who have diabetic polyneuropathy affecting both small and large nerve fibers will be enrolled. Participants must have stable diabetes treatment for at least 3 months and be able to take oral medication. People with other nerve diseases, major psychiatric conditions, or serious health problems will not be able to take part. What participants will do Take Normast® 3 or placebo tablets twice a day for 12 weeks while continuing their usual treatments Complete pain and symptom questionnaires Have neurological examinations including quantitative sensory testing, heart and blood pressure tests, the dynamic sweat test, and small skin biopsies to look at intraepidermal nerve fibers Return for follow-up visits at 12 weeks (end of treatment) and 24 weeks (long-term follow-up) Safety and follow-up Researchers will check participants' safety through blood and urine tests and by monitoring any side effects. Participants can stop the study at any time. Where the study takes place This study is being conducted at the Department of Human Neuroscience, Sapienza University of Rome (Italy).

Fibromyalgia syndrome (FMS) is a chronic pain condition characterized by widespread pain, fatigue, sleep disturbances, cognitive symptoms, and autonomic dysfunction, significantly impairing quality of life. Increasing evidence suggests that, beyond central pain dysregulation, patients with FMS frequently exhibit autonomic nervous system dysfunction, characterized by sympathetic nervous system (SNS) hyperactivity at rest, with reduced SNS recruitment during orthostatic challenge. Moreover, approximately 50% of patients with FMS show reduced intraepidermal small fiber density on skin biopsy, a condition referred to as small fiber pathology (SFP), which has recently been suggested to contribute to autonomic dysfunction in these patients. Despite currently available pharmacological and non-pharmacological treatments, therapeutic efficacy remains limited, highlighting the need for novel mechanism-based interventions. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive neuromodulation technique that enhances parasympathetic activity through stimulation of the auricular branch of the vagus nerve. Preliminary studies suggest that tVNS may improve pain, autonomic symptoms, mood, and quality of life in patients with FMS, although available evidence is limited by small sample sizes and heterogeneous methodologies. The RESET-FMS study is a randomized, sham-controlled, double-blind clinical trial designed to evaluate the efficacy of tVNS in patients with FMS. Participants will be randomized in a 1:1 ratio to receive either active tVNS or sham stimulation for four consecutive weeks. Stimulation will be administered daily for 30 minutes using the Nurosym™ device applied at the tragus of the external ear. The primary objective is to assess the effect of active tVNS compared with sham stimulation on fibromyalgia severity, measured by the revised Fibromyalgia Impact Questionnaire (rFIQ) at the end of treatment (T4), adjusted for baseline values. Exploratory objectives include: * evaluation of autonomic symptoms, fatigue, pain distribution, symptom severity, and sleep quality using validated clinical scales, including the Composite Autonomic Symptom Score (COMPASS-31), Fatigue Severity Scale (FSS), Widespread Pain Index (WPI), Symptom Severity Score (SSS), and Pittsburgh Sleep Quality Index (PSQI) at T4; * assessment of the persistence of treatment effects four weeks after treatment discontinuation (T8); * evaluation of treatment effects during intermediate assessments (T2); * evaluation of the effects of tVNS on non-invasive indices of autonomic nervous system function, including heart rate variability (HRV) and sudomotor function assessed by dynamic sweat test (DST); * analysis of serum biomarkers potentially associated with autonomic dysfunction, neuroinflammation, and cognitive symptoms, including neuropeptide Y (NPY), interleukin-6 (IL-6), and neurofilament light chain (NFL); * comparison of treatment response between patients with and without evidence of small-fiber pathology on skin biopsy; * identification of clinical and biological predictors of response to tVNS. The study is expected to provide clinically relevant evidence regarding the efficacy and safety of tVNS in FMS and to improve the understanding of the relationship between pain modulation, autonomic dysfunction, and peripheral nervous system involvement in this condition. The identification of predictors of treatment response may contribute to the development of more personalized therapeutic strategies for patients with FMS.

The purpose of this study is to prospectively investigate the temporal sequence of premonitory symptoms across multiple migraine attacks.

The goal of this observational study is to learn about the neuropsychological profile of Sturge-Weber Syndrome (SWS) in children and adults with this rare neurocutaneous condition. SWS affects approximately 1 in 50,000 live births and is characterized by brain blood vessel malformations, facial port-wine stains, and abnormal vascularization in the brain, skin, and eyes. Patients are at high risk for epileptic seizures, stroke-like episodes, glaucoma, and motor and cognitive difficulties. The main questions it aims to answer are: * What are the specific cognitive strengths and weaknesses in visuospatial abilities, working memory, and executive functions in individuals with SWS? * What is the detailed neuropsychological profile of patients with SWS who do not have intellectual disability? * Are there different cognitive-behavioral phenotypes between patients with and without the characteristic facial port-wine stain (PWS)? * How do clinical variables such as seizure history and brain involvement patterns relate to specific cognitive deficits? Participants will undergo a comprehensive neuropsychological assessment battery that includes: * Intellectual functioning tests (K-BIT2) to measure verbal and non-verbal intelligence * Executive function evaluation (BRIEF2) assessing behavioral regulation, emotional regulation, and cognitive regulation * Language assessment including receptive vocabulary (PPVT) and grammatical comprehension (TCGB-2) * Visuospatial skills testing (Beery-Buktenica VMI) evaluating visual-motor integration * Working memory assessment (WISC-IV/WAIS-IV digit span and spatial span subtests) * Learning abilities evaluation including reading (Battery for the Assessment of - Developmental Dyslexia and Dysorthography), writing, and mathematical skills (ABCA test) * Additional assessments for attention, verbal memory, and spatial memory as needed The study will recruit SWS patients through collaboration with patient associations and Telethon support. Participants will continue their standard medical care throughout the study, and all medications and therapies will be recorded. The neuropsychological testing will be conducted at IRCCS San Raffaele and Sapienza University Department of Psychology. The study aims to identify a cognitive-behavioral phenotype for SWS, develop evidence-based guidelines for neuropsychological monitoring, create personalized recommendations for educational adaptations, produce training materials for healthcare professionals and educators, and establish a multidisciplinary framework for supporting individuals with SWS. This research addresses a critical knowledge gap, as previous studies have focused mainly on general intellectual functioning and the prevalence of intellectual disability and language disorders, without providing detailed neuropsychological profiles, particularly for patients without intellectual disability.

This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.

Acute coronary syndromes (ACS) are frequently associated with multivessel coronary artery disease (CAD), and current guidelines recommend complete revascularization beyond the culprit lesion. Angiography-guided PCI is the standard approach, but anatomical assessment does not always reflect the functional significance of intermediate lesions, while FFR-guided strategies are limited by the need for pressure wires and hyperemia. Murray-law-based quantitative flow ratio (μFR) is a wire-free angiography-derived physiological index that may improve decision-making for revascularization in ACS patients. The Core-μFR is an investigator-driven, multicenter, randomized, open-label and prospective trial designed to evaluate whether μFR can act as a gatekeeper for complete revascularization in patients with ACS and multivessel disease by identifying non-culprit lesions that truly require PCI. Patients with ACS (either STEMI or NSTE-ACS) undergoing primary PCI will be considered eligible if they present multivessel CAD on visual assessment with the intention to treat the non-culprit vessel in a staged procedure within the same hospitalization. After the pPCI, eligible patients will be randomized to either group A or group B and μFR will be performed in a blinded fashion with the operator unaware of the functional result. Patients in group A will undergo a staged PCI of all NCVs guided by coronary angiography, as per standard of care. In group B, μFR will be used as a gatekeeper for staged revascularization. Operators will only be informed whether at least one non-culprit vessel is μFR-positive, without disclosure of the specific vessel involved or the μFR values. If at least one non-culprit vessel has μFR ≤0.80, patients will undergo angiography-guided PCI of all non-culprit vessels previously deemed suitable for treatment by visual assessment. If μFR is \>0.80 in all non-culprit vessels, staged PCI will be deferred and the patient will be discharged without further revascularization. Finally, to test the functional reproducibility, a blinded post-hoc μFR assessment will be performed on the baseline angiograms of the staged procedures in all the patients undergoing complete revascularization. Clinical follow-up will be performed at 30 days and 1 year from randomization.

PATIENTS AFFECTED BY ADRENAL GLAND DISEASE WITH SURGICAL INDICATION OF ROBOTIC OR LAPAROSCOPIC ADRENALECTOMY

The aim of the study is to assess the effect of a combination of Magnesium, Palmitoylethanolamide, high-molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin D in women at risk of preterm birth (PTB).

This randomized clinical trial evaluates the efficacy of a microRepair ABX mouthwash mousse compared to 0.20% chlorhexidine in promoting wound healing following tooth extraction. The study monitors clinical parameters such as pain, swelling, and healing indices at 1, 7, and 15 days post-surgery. The primary objective is to determine if the microRepair ABX technology enhances tissue regeneration and reduces post-operative complications.

This observational study explores the legal and ethical boundaries of dental communication on social media, analyzing Italian regulatory evolution. Through surveys involving dental professionals and patients, it assesses awareness of advertising regulations and the impact of digital communication on the patient-practitioner relationship. The research identifies knowledge gaps regarding deceptive advertising and highlights the need for transparent, deontologically compliant digital practices to protect public health.

This observational epidemiological study aims to assess the prevalence of gummy smile and altered passive eruption in a young adult population, with a focus on the second sextant. Periodontal and aesthetic parameters, along with patient-reported discomfort, will be analyzed to identify potential correlations and underlying anatomical factors.

This study investigates clinical approaches to orthodontic debonding and post-debonding finishing, focusing on enamel preservation. An observational epidemiological survey was conducted among dental professionals to assess commonly used techniques, instruments, and complications. Results highlight variability in clinical protocols, with mechanical methods being the most widely adopted. The study emphasizes the importance of minimally invasive strategies to reduce enamel damage and improve patient outcomes.

This study aims to address this evidence gap by comparing a step-up oral-first strategy with an early IV iron strategy in pregnant women diagnosed with anemia after 34 weeks of gestation.

Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy. Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis. Perspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway. Implications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care. Additionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.

The progressive aging of the population worldwide yields profound health and social implications. Aging entails a progressive impairment of functions and, ultimately, leads to increased susceptibility to morbidity and mortality. Unsurprisingly, over 85% of people over 75 years of age suffer from chronic diseases. Notwithstanding, healthcare systems, usually organized for acute conditions, are not structured to provide effective and efficient care for chronic conditions. Patients with chronic conditions often present a complex interplay of multimorbidity, polypharmacy and frailty. These determinants of health, which are tightly intertwined, are further modulated and influenced by several characteristics of patients, including sex, socio-economic factors and the broad spectrum of the so - called gender-related characteristics of the individuals. The combination of these determinants - whose interaction is often unpredictable - contribute to defining the prognosis of these patients. Frailty is proposed as a state of increased vulnerability and strongly characterizes the older population (Clegg A, Lancet 2013; 381: 752-62). Nonetheless, older age does not always imply a condition of frailty. The development of a simple frailty index can be useful in clinical practice to stratify patients according to their level of frailty, taking into account the specific gender peculiarities, and may facilitate the appropriate tailoring of social- and health-related interventions. One of the factors that accelerates biological aging and increases susceptibility to frailty is a chronic, low-grade and systemic inflammation known as inflammaging. (Ferrucci L, et al. Nat Rev Cardiol 2018). Aging-associated platelet hyperreactivity is driven by chronic inflammation (Pavel Davizon-Castillo et al. Blood 2019) and is associated with chronic age-related cardiovascular disease and mortality. In turn activated platelets fuel inflammation creating a vicious cycle known as thromboinflammation. Both the hemostatic and the immune system display sexual dimorphism and are susceptible to gender-related factors, such as diet, stress, workload, etc. Identification of thromboinflammatory biomarkers could be a novel valuable asset to understand and predict frailty in a more sex and gender sensitive manner in the aging population. Another aging feature is malnutrition, which can significantly contribute to quality of life and clinical outcomes. In particular, the age-related progressive loss of muscle mass and function (i.e.,sarcopenia) reduces the autonomy of older adults, impinges on their quality of life and reduces the tolerance to chronic as well acute therapeutic interventions. Recent evidence suggests that sarcopenia could be considered as a proxy for biological age (Mandelblatt et al. JAMA Oncol 2021). Therefore, timely diagnosis and treatment of impending malnutrition and sarcopenia could ameliorate not only patients' quality of life but survival as well (Bargetzi L et al. Ann Oncol 2021). Sarcopenia and inflammation are associated with osteoarthritis, the most common degenerative joint disease and a leading cause of frailty and disability in the elderly (Wang H, et al. Plos One 2022). The frailty Index (alone or associated with biomarkers) may not include all factors that impact life expectancy yet. It is a well-described clinical phenomenon that females live longer than males yet tend to experience greater levels of co-morbidity and disability. Gender-sensitive factors may be relevant in this context. Expectations and responsibilities associated with gender roles may contribute to the willingness (and ability) of the sexes to adopt a "sick" role, seek help and access to health care (Hibbard JH, et al. Women Health 1986). While social vulnerability is weakly to moderately correlated with frailty in both sexes, females are more socially vulnerable than males due to their living situation (widowhood and living alone) (Andrew MK, et al. BMC Geriatrics 2014). Even so, females may be better able to cope with higher levels of frailty due to greater social support networks. Males may be more vulnerable to the effects of social isolation, particularly widowhood, both in terms of frailty and mortality (Shor E, et al. Demography 2012). In conclusion, clinical, biological, social and behavioral factors (captured by gender) may contribute to the frailty burden. To date, few studies have presented frailty scores stratified by sex and, overall, results have not been consistent (Gordon EH, et al. Maturitas 2018). Appropriate tailoring of social- and health-related interventions is critical to reduce potential harm from inappropriate procedures and maximize benefits from therapeutic intervention in such a complex population. Stratification of patients based on their gender and frailty status has the potential to tailor their care more precisely, shift the emphasis in medicine from reaction to prevention and reduce the health cost burden.

This is a multicenter study designed to assess the effects of groundbreaking CAH therapies on a spectrum of clinical and biochemical outcomes, with a special emphasis on reproductive and sexual health. Fertility is a profound concern for individuals with CAH, given the high prevalence of gonadal dysfunction that arises from the hormonal derangements that characterize this complex disease. At our endo-ERN accredited center for rare diseases at Policlinico Umberto I, addressing these fertility issues in CAH patients represents a daily commitment. The revolution of the pharmacological management of CAH is one of the most debated topics to date. Data on the effects of novel management options for CAH on fertility are scarce, but the anecdotal improvements in sperm count and menstrual regularity reported in the latest clinical trials have significantly motivated us to design the CALLIOPE study. Thus, we aim to delve deeper into the fertility and sexual function of CAH patients, employing advanced seminal parameter evaluations, multiparametric gonadal ultrasound, and sophisticated hormonal analyses in both females and males performed by ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS). Beyond fertility, the CALLIOPE trial aspires to provide further understanding of therapy's effects on body composition, metabolism, immune function, coagulation, and quality of life, among other factors. We will explore the immunological impact of novel CAH therapies by quantifying Peripheral Blood Mononuclear Cells (PBMCs) and analyzing transcriptomic profiles to unveil gene expression patterns and identify biomarkers that could signal therapeutic targets or disease management strategies in CAH. Moreover, seminal plasma will be used to assess the expression of adrenal miRNAs regulating steroidogenesis and metabolism. The research will be conducted at our rare disease referral center (Policlinico Umberto I, Sapienza University of Rome) in collaboration with leading centers across Italy: Modena (Università degli Studi di Modena e Reggio Emilia), Naples (Università Federico II), Rome (Ospedale Sant'Andrea) and Bologna (Alma Mater Studiorum - Università di Bologna). https://isidorilab.com/home

Postpartum hemorrhage (PPH) remains one of the leading causes of maternal morbidity and mortality worldwide, particularly in low- and middle-income countries. It is defined as blood loss of more than 500 mL after vaginal delivery or more than 1000 mL after cesarean section, but severe PPH is typically identified when blood loss exceeds 1000 mL regardless of delivery mode. The initial management of PPH includes the administration of uterotonics such as oxytocin, methylergometrine, and tranexamic acid. However, a subset of patients remains unresponsive to medical therapy, necessitating second-line interventions to avoid escalation to invasive procedures such as uterine artery embolization or peripartum hysterectomy. An intrauterine balloon tamponade device (Bakri©), is commonly used as a mechanical method to control uterine bleeding by exerting direct pressure on the uterine walls. Its use has been widely adopted and incorporated into international guidelines due to its relative ease of use and safety profile. Despite its effectiveness, the failure rate of Bakri balloon placement can range from 20% to 40%, especially in cases of coagulopathy or diffuse atony. Gauzes with a chitosan-based hemostatic dressing (Celox PPH ©) , has been extensively used in trauma settings and is increasingly being explored for surgical and obstetric applications. Its mechanism involves promoting clot formation independent of the clotting cascade, making it potentially beneficial in patients with coagulopathies. Preliminary data and case reports suggest that Celox PPH© may be effective in controlling intrauterine bleeding when used as a packing material after vaginal or cesarean delivery, but no high-quality randomized controlled trial has yet compared it directly with standard interventions. Given the clinical need for alternative second-line treatments for PPH unresponsive to medical therapy, this study proposes a head-to-head comparison of the Bakri balloon and Celox gauze. The findings will help inform evidence-based guidelines and may offer new strategies to reduce maternal transfusion requirements, prevent hysterectomy, and shorten hospital stays in patients experiencing severe PPH.

Induction of labor (IOL) is a frequently performed procedure in obstetrics, aimed to achieve vaginal delivery when continuing the pregnancy is no longer advisable. A key determinant of IOL success is cervical ripening, particularly when the cervix is initially unfavorable. A range of preinduction methods is available, encompassing both mechanical and pharmacological approaches. Among mechanical techniques, the double balloon catheter (CRB) facilitates cervical dilation by applying direct pressure, which stimulates local prostaglandin release. In contrast, Dilapan-S, a synthetic osmotic dilator, works by gradually expanding through the absorption of cervical fluids, thereby applying gentle mechanical pressure. While both methods are widely used and generally considered safe, there is limited evidence directly comparing their effectiveness and patient-centered outcomes. Mechanical methods are associated with a lower risk of uterine hyperstimulation compared to pharmacological alternatives. The choice between CRB and Dilapan-S may significantly influence labor duration, cesarean delivery rates, maternal comfort, and hospital resource utilization. This study aims to fill the existing knowledge gap by directly comparing Dilapan-S and CRB for term preinduction, with a focus on clinical efficacy and maternal satisfaction.

This is a multicentre, controlled, observational prospective study on new biomarkers, as immune profiling, angiogenetic markers and circRNA from TEPs in the diagnosis and in the evaluation of treatment response in pulmonary and gastro-entero-pancreatic NENs.

This is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with Klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis.

The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.