Articles tagged with Clinical Trials
The Cool AMI EU pivotal trial evaluated the safety and effectiveness of systemic mild hypothermia as an adjunctive therapy to primary PCI in patients with anterior STEMI. The trial showed significant differences between treatment groups, including longer randomization-to-balloon time and total ischemic time.
Research suggests that higher pulse rates among non-sleepy obstructive sleep apnea patients with coronary artery disease may be associated with increased risk of cardiac events. However, CPAP therapy has been shown to provide protection for these patients, particularly those with high pulse rate responses.
A randomized double-blind controlled trial of convalescent plasma for adults hospitalized with severe COVID-19 found mortality at 28 days in the treatment arm was half the rate seen in the control arm. However, treatment was not associated with other improvements in clinical status among patients.
Brigham cardiologists presented findings on IL-6 inhibitors, SGLT1/2 inhibitors and statin drugs in COVID-19 patients, highlighting potential benefits and limitations. The studies suggest new therapeutic options for preventing future cardiovascular events and improving outcomes for patients with heart failure and kidney disease.
The study found that rivaroxaban significantly reduced the occurrence of total severe events in patients with symptomatic peripheral artery disease who underwent lower extremity revascularization. The treatment also showed a 12.5% absolute reduction in risk for adverse events in this high-risk population.
The study analyzed over 36,000 LAAO procedures performed with the WATCHMAN device in older, higher-risk patients with atrial fibrillation. At one year, the estimated 1.53% ischemic stroke rate was lower than predicted by stroke risk scores, suggesting effective stroke prevention.
Clinical trials for pancreatic ductal adenocarcinoma consistently exclude minority groups, who experience poorer health outcomes. The lack of diversity in these trials hinders the development of targeted treatments due to racial differences in tumor biology and therapeutic response.
A large-scale trial of annual screening for ovarian cancer found that neither method reduced deaths from the disease, contradicting expectations. Early detection strategies detected cancers earlier, but this did not translate into saving lives.
C-Path and Tufts Medical Center collaborate to integrate patient-level clinical trial data and real-world data to generate actionable real-world evidence for neonatal drug development. The partnership aims to improve survival and outcome for preterm neonates with limited new drug development.
Researchers have successfully used a brain-computer interface to record brain signals associated with handwriting and create text on a computer in real time. The system allows individuals with severe speech or motor impairments to communicate rapidly and accurately, with a trial participant typing at a rate of 90 characters per minute.
Research from the Com-COV study shows that mixing COVID-19 vaccine doses can lead to more frequent mild-moderate symptoms, but adverse reactions are short-lived and no safety concerns were found. The study's findings suggest that mixed schedules could result in increased work absences after vaccination.
A new AI-powered ECG screening tool detected asymptomatic low ejection fraction in patients with improved diagnosis rates. The study found that the AI intervention increased the diagnosis of low ejection fraction by 32% relative to usual care.
A new study found a substantial decrease in minimally invasive surgery use for cervical cancer after the publication of a major study in 2018. The study assessed 2,437 patients and showed that surgeons changed their methods, but still saw room for improvement at non-academic medical centers.
A new digital decision-aiding tool, ASSIST, has been developed to help physicians choose between non-invasive diagnostic tests for patients with chest pain. The tool uses machine learning techniques to identify the most appropriate imaging test based on patient characteristics.
A new study reveals that only 32.3% of US patients undergoing PCI for SIHD met ISCHEMIA trial inclusion criteria, while others had high-risk features or negative functional testing. These findings suggest the trial's results may not be representative of real-world interventional practice.
A quality improvement study evaluated the length, readability, and complexity of COVID-19 vaccine phase III randomized clinical trial informed consent documents. The study found that these documents were often lengthy and complex, posing a barrier to participant understanding.
A new study from the University of Missouri School of Medicine found that people of color, those with a higher income, and younger individuals are more likely to participate in cancer clinical trials. The analysis of 20,053 respondents showed an average overall clinical trial participation rate of 6.51%, with significant differences in...
A Phase 2b trial will test Dalbavancin for safety and efficacy in treating complicated S. aureus bacteremia in hospitalized adults. The study aims to validate a dalbavancin regimen of one dose a week for two weeks, potentially leading to a shorter and less invasive treatment.
The UK Markey Cancer Center has launched a clinical trial to evaluate the anti-cancer activity of ArtemiLife coffee products in preventing ovarian cancer recurrence. Participants will drink coffee up to four times daily for five months after completing treatment, aiming to delay or eliminate cancer return.
A Phase IIb trial of a candidate malaria vaccine, R21/Matrix-M, demonstrated high-level efficacy of 77% over 12 months. The vaccine has been well-tolerated and is the first to meet the World Health Organization's goal of a vaccine with at least 75% efficacy.
A study investigated racial/ethnic representation in ophthalmology drug trials approved by the FDA. It found significant disparities, highlighting a need for increased diversity in clinical trial participation.
The NRG-BR001 trial found SBRT to be safe for patients with multiple metastases, with no dose-limiting toxicities and over 50% of participants alive at 2 years. The study used extensive radiation QA processes and was the first to require 3D image guidance during treatment.
A phase 1 clinical trial found that stereotactic body radiation therapy (SBRT) is safe for treating patients with multiple metastases. The treatment used precisely targeted beams of high doses of radiation to destroy tumors, reducing damage to noncancerous tissue.
Researchers assessed the effectiveness of treating preterm infants with umbilical cord blood-derived mesenchymal stem cells (UCB-MSCs) directly into their tracheas. Early results showed signs of improvement for the most immature infants included in the trial, but further study is needed to solidify therapeutic benefits.
Researchers at Penn Medicine delivered a new gene therapy that improved vision in three patients with severe vision impairments. The therapy showed sustained improvements in day and night vision, without serious side effects.
A new once-a-week injectable insulin therapy has proven safe and as effective as daily insulin injections in two international clinical trials. The treatment may provide a convenient alternative to the burden of daily insulin shots for diabetes patients, improving long-term adherence and glucose control.
A retrospective study suggests that MitraClip reduces death and heart failure hospitalizations by up to 50% for patients with secondary MR, even with slightly smaller mitral valve openings. The study also found improvements in quality of life measures in some patients with higher gradients.
Researchers at MUSC developed RINS, a digital platform that integrates clinical study data from disparate systems, providing metrics on translational science efficiency and effectiveness. This allows for informed decisions on improving translational research practices.
Researchers found that percutaneous peripheral nerve stimulation significantly reduced postoperative pain scores by over 50% and opioid consumption by 80%. The technique, which delivers mild electrical stimulation to the nerve, could be a safe and effective adjunct for pain management after surgery.
A new study suggests that long-term survival data for immunotherapies should be re-analyzed for potential misinterpretation. Researchers propose an adjustment method, Cox-TEL, to correct inaccurate results based on the Cox proportional-hazards model.
A recent study published in The BMJ found that discontinuing oxytocin stimulation during induced labour may lead to a reduced risk of uterine hyperstimulation and abnormal fetal heart rate. This finding suggests that routine discontinuation of oxytocin stimulation could be beneficial in settings with limited monitoring resources.
The NIH is conducting a Phase 2 trial to test the safety and efficacy of an anti-CD14 antibody, IC14, in treating hospitalized COVID-19 patients with low blood oxygen. The study aims to determine if treatment with IC14 decreases recovery time and reduces disease severity.
A small clinical trial found that cloth face coverings reduce exercise performance and increase shortness of breath and claustrophobia at higher intensities. The researchers suggest modifying exercise frequency, intensity, duration, and type to compensate for the discomfort associated with mask-wearing.
A study published in JAMA Internal Medicine found that training physicians to use time-limited trials of ICU treatments improves the quality of family meetings. This approach engages families in decision-making, reducing unnecessary ICU treatments for critically ill patients with poor prognoses.
Global clinical trial completion rates dropped by 13-23% during the COVID-19 pandemic, according to a new study. The decline was most significant in trials funded by government, academic or medical entities, and was attributed to reduced patient enrollment and increased challenges in following up on patients.
A new clinical trial has shown that the SlowMo therapy app is an effective means of treating paranoid thoughts in people experiencing psychosis. The app, which uses a personalized approach to help individuals feel safer in daily life, has been found to reduce paranoia and improve quality of life.
Researchers at Michigan Medicine are conducting a nationwide trial to investigate allergic reactions to COVID-19 mRNA vaccines. The study aims to identify molecular markers of allergic reactions, with results expected in late summer 2021.
A collaboration between Michigan State University, Spectrum Health, and Niowave is testing a new radiotherapy approach for bladder cancer. The therapy combines radiotherapy with immunotherapy, which helps the patient's immune system fight off disease, aiming to improve safety and effectiveness.
Researchers at Brown University have successfully demonstrated the use of an intracortical wireless BCI system in clinical trial participants with tetraplegia. The system enables users to point, click and type on a tablet computer with high accuracy and fidelity, opening up new possibilities for people with paralysis.
A systematic review of 31 clinical trials found that vaginal progesterone and 17-OHPC reduced the risk of preterm birth before 34 weeks for high-risk single baby pregnancies, particularly for women with a previous preterm birth or short cervix.
The NIH has started a Phase 1 clinical trial to evaluate the safety and immunogenicity of Moderna's COVID-19 variant vaccine, mRNA-1273.351, designed to protect against the B.1.351 SARS-CoV-2 variant. The trial enrolls approximately 210 healthy adult volunteers and aims to assess the reactogenicity and immune response of the vaccine.
The Cohen Center will provide comprehensive, coordinated treatment for patients with Lyme and tick-borne diseases, offering affordable care with experienced physicians. The center will also integrate research and physician training into its clinical model, aiming to address the growing need for evidence-based treatments.
A new malaria vaccine aims to stop mosquitoes from transmitting Plasmodium parasites to people by immunizing them against infection. The vaccine, developed by University of Florida researcher Rhoel Dinglasan, has shown promise in laboratory studies and is now set to be tested in humans.
A pilot human clinical trial found that GlyNAC improved various age-related defects, including glutathione deficiency, oxidative stress, and mitochondrial dysfunction. The benefits were maintained for 24 weeks but declined after stopping supplementation.
Aerobic exercise has been shown to lessen several hemodialysis-related symptoms, including restless leg syndrome, symptoms of depression, muscle cramping, and fatigue. However, more research is needed to determine the extent of benefits from aerobic exercise for individuals with kidney failure who are undergoing dialysis.
A study by Jiarui Li and colleagues investigated representation of Black Americans in clinical trials for cardiovascular drugs approved by the FDA between 2006 and 2020. The researchers found that Black Americans were underrepresented in these trials, highlighting a need for increased diversity in clinical research.
Researchers found conservatives less willing to participate in medical research due to lower trust in science and ideological differences. The divide could threaten the generalizability of studies, impacting the quality and relevance of medical findings.
A new review identifies key personality traits associated with positive and negative psychedelic experiences, suggesting that individuals open to new experiences and willing to surrender may benefit from the therapy. Researchers propose using lower doses as a starting point for hesitant patients, building up to higher doses later.
The AstraZeneca vaccine demonstrated high vaccine efficacy of 78.9% against symptomatic COVID-19 disease, including severe disease or hospitalization. The vaccine also showed no increased risk of thrombotic events or cerebral venous sinus thrombosis among vaccinated participants.
Researchers at Vall d'Hebron Institute of Oncology are conducting a first-in-human Phase I trial to evaluate the safety and efficacy of Peptomyc's novel Myc inhibitor Omomyc in treating advanced solid tumors. The trial aims to confirm the compound's therapeutic potential, particularly for patients with progressed disease.
A recent SWOG Cancer Research Network study found that even with access to clinical trials, cancer patients living in the poorest neighborhoods have a nearly 30% greater chance of dying from their disease. The disparity persists despite uniform high-quality care.
A landmark South African study validates the need for second-generation Covid-19 vaccines, as the AstraZeneca vaccine showed minimal protection against mild to moderate infections caused by the B.1.351 variant. Despite this, the WHO recommends continued deployment of the vaccine in countries where the variant circulates.
A recent study published in Annals of Surgery found that antibiotic-only treatment for acute uncomplicated appendicitis resulted in high recurrence rates and inferior quality of life. In contrast, surgical intervention delivered better outcomes, including a significantly improved quality of life score.
A randomized clinical trial found that wearing clear masks reveals surgeons' faces, improving patients' perceptions of communication, trust, and empathy. This study suggests a potential benefit to using clear masks in surgical clinics.
A large-scale randomized trial involving nearly 24,000 women found no significant differences in health outcomes between two gestational diabetes screening methods. The study evaluated rates of gestational diabetes diagnosis, large-for-gestational-age infants, and adverse perinatal outcomes.
The CCE-DART project aims to develop interconnected tools to reduce the complexity of investigator-initiated trials, incorporating cutting-edge digital technologies. It will harmonize molecular multi-tier profiling platforms to precisely match patients to novel anti-cancer medicines based on genetic tumor specificities.
The Medical University of South Carolina has enrolled children with multisystem inflammatory syndrome in children (MIS-C) in a trial of remestemcel-L, a novel cellular therapy. The treatment showed significant improvement within 24 hours for two patients, offering hope for better management of the rare but life-threatening condition.
The BrainHealth Project trial unveiled a novel online platform delivering science-backed approach to measuring, improving, and tracking brain fitness. Participants showed significant improvements in their BrainHealth Index scores, with positive changes observed across various domains of brain health.
The FDA has qualified the DIBSS-C, a patient-reported outcome measure, to assess symptom-based efficacy endpoints in IBS-C clinical trials. This qualification reflects FDA's commitment to patient-focused drug development and is a major milestone for the IBS Working Group.
A comprehensive review of lung cancer screening trials reveals both benefits and harms, leading to updated USPSTF recommendations. Screening can lower lung cancer deaths in high-risk individuals, but also leads to false positives and unnecessary procedures.