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Found 17 Actively Recruiting clinical trials
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Researchers are evaluating how well measuring symphysis fundal height (SFH) alone compares to SFH combined with point of care ultrasound measuring fetal abdominal circumference (POC-US-AC) in detecting babies who are smaller or larger than normal for their gestational age among low-risk pregnant women after 35 weeks. This study aims to find the most accurate way to identify abnormal fetal growth, which is linked to problems for both mother and baby. The study is an open-label randomized controlled trial involving two groups to compare these screening methods, with further confirmation by formal obstetric ultrasound when abnormalities are suspected. Women in the study will be randomly assigned to either SFH measurement alone or SFH plus POC-US-AC during routine antenatal visits at 35-38, 40, 41, and beyond 41 weeks of pregnancy. Midwives trained in both methods will perform the measurements. If growth abnormalities or abnormal amniotic fluid levels are suspected based on these screenings, a formal ultrasound by a specialist will be done for confirmation. All participants will receive a POC-US at 41 and 41+ weeks to check amniotic fluid regardless of their group. Participants will be assessed through ultrasound evaluations, medical history reviews, and fetal growth measurements during scheduled visits. Birthweights will be compared to prenatal findings to classify infants as small, appropriate, or large for gestational age. The primary outcome is the number of infants identified as small or large for gestational age from enrollment until about one year after birth. Safety and fetal growth will be closely monitored throughout the pregnancy with detailed measurements and follow-ups.
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Researchers are evaluating the use of lutetium (177Lu) edotreotide (Lu-Dotatoc) in patients with certain neuroendocrine tumors and other SSTR-positive cancers that are not currently approved for treatment with LUTATHERA. This includes tumors like bronchopulmonary, ovarian, renal NETs, neuroendocrine carcinomas, pheochromocytomas, paragangliomas, meningiomas, and some other malignancies. The study aims to expand knowledge on the effectiveness and safety of 177Lu-DOTATOC in treating these diseases, focusing on tumor response and safety outcomes in a phase II trial setting. Participants receive four cycles of 177Lu-DOTATOC therapy administered by slow intravenous infusion over 30 minutes using a dedicated pump. Dosage is set at 7.4 GBq for those without risk factors and 5.5 GBq for those with risk factors. The study includes only patients with tumors showing significant uptake on 68Ga PET-CT imaging and disease progression despite standard treatments. All disease stages are allowed, and concurrent somatostatin analog therapy is maintained at the same dose as before progression. During the study, patients undergo assessments including tumor imaging to confirm receptor positivity and measurable disease. Researchers monitor disease control rate over 32 months as the primary outcome. Participants must have adequate organ function and life expectancy over six months. Safety and treatment responses are closely followed throughout the treatment cycles and study period. Overall participation starts with screening, followed by treatment and long-term monitoring of disease control and safety.
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Researchers are evaluating the safety, tolerability, and effectiveness of valemetostat tosylate combined with DXd antibody-drug conjugates (ADCs) in patients with advanced solid tumors, including HER2-positive gastric cancer, non-squamous non-small cell lung cancer (NSCLC), and unresectable or metastatic HER2 low breast cancer. This Phase 1b study aims to determine the recommended dose for further study and to assess treatment effects in these patient groups. The study has two parts: Part 1 involves dose escalation where valemetostat is given orally once daily, combined with either T-DXd or Dato-DXd administered by intravenous infusion every three weeks on Day 1 of each 21-day cycle. After identifying the recommended dose, Part 2 will expand to further evaluate safety and tolerability of this combination treatment. Participants will undergo regular assessments including imaging scans every 6 weeks during the first year and every 12 weeks thereafter to evaluate tumor response. Safety will be monitored from screening through 40 days after the last dose. Researchers will track adverse events and dose-limiting toxicities during the treatment cycles, which last 21 days each. Follow-up may continue for up to approximately 5 years to observe long-term outcomes.
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Researchers are evaluating whether blue light (BL) photobiomodulation can improve healing of donor site (DS) wounds in adults with intermediate to deep burn injuries who undergo surgical skin grafting. The study aims to determine if adding BL therapy to standard wound care can reduce healing time, improve wound conditions, reduce pain and infection signs, and enhance long-term scar quality. This is a controlled clinical trial using a CE-marked blue light device (EmoLED) already approved for clinical use. Participants will receive the standard treatment for donor sites, which includes routine wound care and dressings. One donor site area on the right side will also receive weekly BL therapy sessions lasting 60 seconds each for about 3 to 4 weeks, while the donor site on the left side will receive only standard care. The study design uses each participant as their own control by comparing two different donor site areas on the same patient. Throughout the treatment period of approximately 4 to 5 weeks, participants will attend weekly clinical evaluations where wound healing, pain levels, and wound bed conditions will be assessed. Skin swabs will be taken to check for infections, and any local side effects of BL therapy will be monitored. After complete healing, follow-up visits at 1 and 3 months will assess scar quality and monitor for any late side effects. The main outcome measured is the donor site healing time from enrollment to the end of treatment.
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Researchers are evaluating the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.
Actively Recruiting
Researchers are evaluating the diagnostic criteria currently used to identify placenta accreta, a condition where the placenta abnormally attaches to the uterus, and they aim to understand maternal outcomes related to different management strategies. The study focuses on comparing conservative management, where the placenta is left in place during cesarean section, versus more radical management involving cesarean section followed by hysterectomy. This study is both retrospective and prospective, conducted across multiple centers nationally, and seeks to help standardize care for suspected placental accretism cases. Patients will receive treatment according to usual clinical practice without experimental interventions. Data collection includes main instrumental findings of suspected placenta accreta cases, and monitoring will cover pregnancy progression and postpartum periods using laboratory and instrumental tests. Clinical trends are tracked through vital signs, laboratory tests, ultrasound, and other examinations during pregnancy, immediately after surgery, and at follow-up outpatient visits. Prepartum visits generally occur twice weekly if no complications arise, while postpartum follow-up varies depending on the procedure used and any complications. Participants will be monitored for the accuracy of prenatal diagnosis compared to findings during surgery, focusing on outcomes up to one month after birth. There are no questionnaires or rating scales involved. The study tracks vital and laboratory parameters, imaging results, and clinical progression to assess the safety and effectiveness of management approaches. Monitoring continues through immediate postoperative periods and outpatient visits to gather comprehensive maternal and fetal outcome data.
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Status epilepticus (SE) occurs in 20-30% of patients in coma after cardiac arrest and is often resistant to medical treatment, leading to a poor prognosis. The best treatment approach for refractory and super-refractory post-anoxic SE remains uncertain, with ethical challenges around continuing or stopping intensive therapy. Research suggests that patients with super-refractory post-anoxic SE who have favorable prognostic signs may achieve good functional recovery if treated intensively and for a prolonged period. This study compares the effectiveness and safety of a combined anti-glutamatergic therapy using ketamine and perampanel against other antiseizure and anesthetic treatments. Patients in the dual therapy group receive ketamine intravenously for three days with doses adjusted by EEG patterns, alongside oral perampanel through a feeding tube for five days with dosing based on weight. Other patients receive standard antiseizure and anesthetic treatments excluding these two drugs. The study is retrospective and involves multiple centers across Italy, focusing on patients with super-refractory status epilepticus after cardiac arrest. Participants are adults with coma after cardiac arrest treated in intensive care with continuous EEG monitoring and confirmed super-refractory SE. Researchers will review patient records to measure how many achieve resolution of status epilepticus during their ICU stay, up to 30 days. The study monitors neurological outcomes, safety, and therapy feasibility, aiming to inform future clinical trials without altering routine care or treatment protocols.
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Cesarean section is a common surgical procedure that causes significant pain, requiring effective pain management. This research compares two pain control methods after cesarean section: a postoperative Erector Spinae Plane (ESP) Block and intrathecal morphine. The study aims to assess the quality of recovery using the Quality of Recovery-11 (QoR-11) questionnaire in women undergoing this surgery. Participants will receive either an ultrasound-guided ESP Block at the T9 level with ropivacaine administered bilaterally at the end of surgery, or intrathecal morphine given during spinal anesthesia combined with a local anesthetic. These treatments are part of a multimodal analgesic approach to manage postoperative pain and improve recovery. During the study, researchers will evaluate recovery quality on the first day after surgery using the QoR-11 questionnaire. They will also monitor pain levels, opioid use, side effects related to opioids, time to mobilization, breastfeeding outcomes, and hospital stay duration. Participants are adult women aged 18 to 45 scheduled for elective cesarean section, and the study includes careful monitoring to gather these outcome measures.
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Researchers are conducting a study to continuously evaluate the quality of healthcare provided in semi-intensive care units. The goal is to develop indicators that measure healthcare quality based on data collected from patients in these units and the structural characteristics of the hospitals. This evaluation aims to identify areas of care that need improvement for different types of patients. The study will collect and analyze data over a period of five years. Each year, a report will be produced to show the results and quality levels of care in each semi-intensive care unit. This ongoing monitoring will help assess the care provided and guide improvements. Participants in the study are patients hospitalized in semi-intensive care units. Data related to patient care and hospital structures will be gathered and used to create quality indicators. The outcomes measured include healthcare quality for various patient risk groups, with continuous evaluation from January 2021 through December 2025. Annual reports will track the progress and effectiveness of care in these units.
Actively Recruiting
Researchers are investigating treatments for men with oligometastatic prostate cancer, which means having 1 to 3 asymptomatic metastatic lesions in soft tissue or bone. This phase II randomized study compares the effects of adding Lutetium 177-PSMA (Lu-PSMA) to stereotactic radiotherapy against stereotactic radiotherapy alone. The study focuses on hormone-sensitive prostate cancer patients who have a biochemical recurrence detected by PSMA PET/CT scans and aims to assess how well these treatments control the disease progression. Participants are randomly assigned to one of two groups. One group receives stereotactic radiotherapy targeting the metastatic sites, delivered in 1 to 5 sessions depending on the tumor size and location. The other group receives the same radiotherapy combined with two cycles of Lu-PSMA, administered by slow intravenous injection at 6 to 8 week intervals with a dose of 7.4 GBq each. Treatments are designed to precisely target cancer lesions while minimizing exposure to healthy tissue. During the study, patients undergo regular assessments including imaging scans and blood tests to monitor prostate-specific antigen (PSA) levels and overall health. The main outcome measured is the length of time participants remain free from PSA progression over 12 months. Safety and side effects are continuously monitored, along with patients' ability to complete treatment and maintain quality of life. The total duration of participation varies depending on follow-up and treatment schedules.
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