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Researchers are evaluating how well symphysis fundal height SFH measurements alone compare to SFH combined with point of care ultrasound POC-US measuring fetal abdominal circumference AC for detecting small or large for gestational age infants among low-risk pregnant women after 35 weeks gestation. The study aims to improve prenatal identification of abnormal fetal growth, which is linked to risks for mother and baby. This open-label, randomized trial is investigator-sponsored and focuses on low-risk pregnancies managed by midwives. Participants are randomly assigned to one of two groups one group will have fetal growth monitored using SFH measurements alone, while the other will have SFH plus POC-US to measure fetal AC and assess amniotic fluid volume. Measurements occur at scheduled antenatal visits at 35-38, 40, 41, and beyond 41 weeks gestation. If screening suggests abnormal growth or amniotic fluid levels, a formal obstetric ultrasound by a specialist will be performed. All women will have POC-US at 41 and 41 weeks to check amniotic fluid, regardless of group. During the study, midwives will review medical histories, conduct physical measurements, and perform ultrasound assessments following the assigned method. Researchers will compare prenatal screening results to actual birth weights to identify small or large infants. They will also track the number of formal ultrasounds requested, cases of abnormal amniotic fluid, and maternal and neonatal outcomes. Participation lasts from enrollment at 35-38 weeks through delivery and initial postnatal assessment, about one year on average.

This trial studies neuroendocrine tumors, paraganglioma, pheochromocytoma, and other SSTR-positive tumors that are not currently approved for lutetium therapy called LUTATHERA. It aims to evaluate the effectiveness and safety of a similar treatment called lutetium 177Lu edotreotide or 177Lu-DOTATOC in patients who have these diseases but are outside the standard indications for LUTATHERA. The study focuses on expanding knowledge about this therapys role in controlling disease and managing side effects. Participants receive treatment with 177Lu-DOTATOC given by slow intravenous infusion over 30 minutes using a pump system. The dose depends on patient risk factors those with fewer than two risk factors receive 7.4 GBq per cycle, while those with two or more risk factors receive 5.5 GBq per cycle. Each participant will receive 4 cycles of treatment. Risk factors include kidney impairment, previous toxicities, uncontrolled diabetes or hypertension, prior therapies, and disease burden. During the study, participants will have regular assessments over several months, including scans to measure disease control at 32 months and ongoing monitoring up to 44 months for progression-free survival, overall survival, safety, and quality of life. Researchers will check blood tests, organ function, and side effects. This non-randomized phase 2 study allows patients with measurable or evaluable disease and progressive tumors confirmed by imaging to be included, with follow-up to evaluate response and safety.

Researchers are evaluating whether blue light BL photobiomodulation can improve healing of donor site wounds in adult patients with intermediate or deep burn injuries treated surgically. The study aims to find out if adding BL therapy to standard care reduces healing time, improves wound conditions, reduces pain and infection signs, is safe, and enhances long-term scar quality. Burn injuries often require skin grafting, and donor sites can have complications that affect healing and patient comfort. Participants will receive standard wound care on both donor sites, with one site also receiving weekly BL therapy using a medical device for 60 seconds per session over 3-4 weeks. The donor site on the right side will get BL plus standard care, while the left side will receive only standard care. This intra-patient controlled design allows direct comparison of healing between treated and untreated areas within the same patient. During the treatment period, participants will have weekly clinical evaluations including wound observation, pain assessments, skin swabs for infection, and photographic documentation. After complete healing, follow-up visits at 1 and 3 months will assess scar quality and check for late side effects. Safety monitoring will record any adverse reactions related to the blue light treatment throughout the study. The total study duration per participant spans about 4-5 weeks of treatment plus follow-up.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

Researchers are evaluating the current main criteria used to diagnose placenta accreta and studying the maternal outcomes related to different management strategies for suspected placental accretism. The goal is to better understand the complications and improve standardization of care for affected pregnant women aged 18 to 44 years. This observational study is both retrospective and prospective and conducted across multiple centers nationally. Patients will receive treatment based on usual clinical practice. The study will collect and analyze key imaging and instrumental findings from cases of suspected accretism. It will compare outcomes between conservative management cesarean section with placenta left in place and more radical management cesarean section with concurrent hysterectomy. Monitoring includes vital signs, laboratory tests, ultrasound, and other examinations during pregnancy, immediate postpartum, and follow-up visits. Participants will have visits twice a week during pregnancy unless complications arise. Postpartum follow-up depends on the procedure performed and any complications. Researchers will assess the agreement between prenatal diagnosis and surgical findings, as well as maternal complications such as surgical site infection up to one month after delivery. No questionnaires or rating scales are used. The study runs until December 31, 2026.

Researchers are evaluating the quality of recovery after cesarean section in women using two different pain management approaches the Erector Spinae Plane ESP Block and intrathecal morphine. Cesarean section is a common surgery that causes significant postoperative pain, which is usually managed with multiple medications. This study aims to compare these two methods to see which may better support recovery, including pain control, mobilization, breastfeeding, and hospital stay length. The study involves two groups of patients undergoing elective cesarean section with spinal anesthesia. One group will receive an ultrasound-guided bilateral ESP Block at the end of surgery using ropivacaine, while the other group will receive a standard dose of intrathecal morphine during spinal anesthesia. The study will assess pain relief and side effects from these treatments to find optimal pain management strategies. Participants will complete the Quality of Recovery-11 questionnaire on the first day after surgery to measure their recovery quality. Researchers will also monitor pain scores at various times, opioid use, side effects, time to mobilization, breastfeeding success, and hospital stay duration. The study starts in June 2025 and is led by AUSL Romagna Rimini, with participants followed closely for outcomes related to their postoperative recovery experience.

This research aims to develop a system for continuously evaluating healthcare quality in semi-intensive care units. By collecting patient data and hospital structure information, the study will identify indicators of unsuccessful care tailored to different patient types. These indicators will help assess the overall quality of care in each semi-intensive care unit over time. The study will last for five years, from 2021 to 2025, during which data from patients admitted to semi-intensive care units will be gathered. Annually, a detailed report will be produced to analyze and compare the results from each unit, helping to track improvements or identify areas needing attention. Participants include all patients hospitalized in participating semi-intensive care units, with an expected total of at least 39,000 patients over the study period. Researchers will monitor outcomes for various patient risk groups to assess healthcare quality. The study involves ongoing data collection and yearly evaluations to support continuous quality improvement in these care units.

Researchers are evaluating treatments for oligometastatic prostate cancer, a condition where patients have 1 to 3 asymptomatic metastatic lesions in soft tissue or bone. This randomized phase II study aims to compare the effects of adding Lu-PSMA, a targeted radioligand therapy, to stereotactic radiotherapy versus using stereotactic radiotherapy alone. The study focuses on hormone-sensitive prostate cancer patients with metastases detected by PSMA PET-CT scans and considers recent advances in imaging and radiation therapy techniques. Participants are randomly assigned to one of two groups. One group receives ablative stereotactic radiotherapy on metastatic sites followed by two cycles of intravenous 177Lu-PSMA-I&T administered at 6-8 week intervals. The other group receives stereotactic radiotherapy alone, delivered in 1 to 5 fractions depending on lesion size and nearby tissues. This approach allows precise, high-dose radiation targeting of metastatic lesions. Treatments are tailored to individual lesion characteristics and patient condition. During the study, participants will undergo regular assessments including PSA testing to measure progression-free survival over 12 months, imaging scans for radiographic progression, and monitoring for adverse events up to 60 months. Quality of life questionnaires will also be used. Safety and overall survival will be tracked throughout the follow-up period. Participants must meet specific health and organ function criteria and use effective contraception during and after treatment. The total duration of follow-up may extend up to five years to evaluate long-term outcomes.

This research aims to assess the early safety and effectiveness of a procedure called percutaneous deep foot venous arterialization in patients with chronic limb-threatening ischemia CLTI who have no other revascularization options. CLTI is the most advanced stage of lower limb arterial disease, carrying high risks of death and major amputation. About 5-10% of patients with peripheral arterial disease develop CLTI, which has a 20% mortality rate within six months of diagnosis. For some patients, standard revascularization methods are not possible or effective, and this study explores an alternative approach to restore blood flow. The study is a multicenter, prospective, single-arm observational study including patients undergoing the PiPER procedure, which involves using veins to reroute arterial blood flow to the foot instead of damaged arteries. The procedure will follow current clinical practice without extra tests or procedures. Patients will be monitored through clinic visits at 30 days, 6 months, 12 months, and 24 months after the procedure to track their progress. Participants will be involved in scheduled follow-up visits where researchers will collect data on their demographics, medical history, treatment details, and health outcomes for up to two years. Assessments will include safety outcomes at 30 days and 6 months, procedural success, blood vessel openness, amputation rates, wound size, oxygen levels in tissues, and disease severity classifications at several intervals. This long-term monitoring aims to evaluate the procedures safety and effectiveness in this high-risk patient group.

Cerebrovascular diseases CVDs are a major cause of illness and death worldwide, with over 30% of strokes having unknown causes. Rare cerebrovascular diseases rCVDs, including inherited conditions like CADASIL, COL4A1 syndrome, and Fabry disease, as well as acquired ones like Sneddon syndrome and Moyamoya arteriopathy, contribute to some of these strokes. These rare diseases are often misdiagnosed due to difficulty in recognition, yet identifying them is crucial for proper management, genetic counseling, and potential therapy. Currently, diagnosis and care are limited to a few specialized centers, mainly in northern Italy, causing patients to travel long distances for care. This observational study aims to create a clinical and research network across Italy to improve diagnosis and understanding of rCVDs, especially in southern regions. The study will describe the clinical features and natural course of these diseases during the first 12 months. Later, between 12 and 30 months, it will explore molecular mechanisms, identify biomarkers, and work towards better clinical and therapeutic management. Participants diagnosed with rCVDs such as CADASIL, Fabry disease, COL4A1, Sneddon syndrome, or Moyamoya arteriopathy who have had at least one brain MRI will be included. Researchers will collect clinical, genetic, and neuroradiological data to characterize these patients and monitor their disease progression. The study does not involve treatments but focuses on gathering information to improve diagnosis and care. Participation may last up to 30 months with ongoing assessments and data analysis.