Articles tagged with Clinical Trials
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Researchers from Trinity College Dublin developed tools for designing vitamin D clinical trials that capture seasonal and population-wide differences. The study found many trials were underpowered, failing to detect a benefit of vitamin D supplementation due to individual differences and seasonal fluctuations.
A survey study explores associations between race/ethnicity, medical mistrust and willingness to receive COVID-19 vaccines. The study found that racial/ethnic group-based medical mistrust is a significant factor in vaccine hesitancy.
The 58th ERA-EDTA Congress features presentations on groundbreaking studies for C3 glomerulopathy, primary IGA nephropathy, focal segmental glomerosclerosis, and end-stage kidney disease. Expert insights into treatment strategies will be shared during the virtual press conference.
A clinical trial found that nearly half of patients treated with nivolumab and ipilimumab were alive six-and-a-half years after treatment, outperforming those who received either drug alone. The combination therapy demonstrated a durable benefit for advanced melanoma patients.
Researchers compared reporting practices for race, sex, and socioeconomic status in randomized clinical trials published in 2015 and 2019. The study found improvements in reporting these factors over time.
The EuroPCR 2021 digital platform hosted 8,091 physicians from over 126 countries, offering a prime learning experience through real-time exchange and interactivity. The event featured 67 late-breaking trials, live chats, and practical Training Workshops, with 3-months access to the replayed Programme.
A new imaging technique using fluorothymidine (FLT) is being tested to predict the success of bone marrow transplants. The trial aims to reduce waiting time for patients and improve survival rates, currently 30% over three years after failure.
The University of Minnesota Medical School is launching a new clinical trial to study the effectiveness of ivermectin, metformin, and fluvoxamine as potential treatments for COVID-19. The multi-site trial aims to prevent hospitalization and 'long COVID' in patients with COVID-19.
The C-Path Virtual Workshop will focus on implementing endpoints and outcome measures for clinical trials in new-onset type 1 diabetes. Over 300 attendees, including researchers, pharmaceutical representatives, and regulatory experts, are expected to participate in the two-day virtual event.
The University of Illinois Chicago is leading a multi-center collaborative to improve community vaccinations, testing, and engagement in clinical research. The Chicagoland COVID Collaborative aims to bolster COVID-19 vaccine confidence and access among Black and Latino communities.
A community health worker intervention has been shown to reduce hospital readmissions among patients discharged to short-term rehabilitation. The study, published in JAMA Network Open, found a 32.3% reduction in readmissions for this population compared to those discharged home.
A randomized clinical trial examined the association between tocilizumab treatment and C-reactive protein levels in patients hospitalized with COVID-19. The study found a positive correlation between tocilizumab treatment and improved survival rates for patients with high C-reactive protein levels.
A dental school researcher has received FDA approval to begin clinical trials for a new cancer therapy using a protein found in an oral bacterium. The treatment, Leukothera, rapidly kills cancer cells without compromising the immune system, offering a potential alternative to existing treatments.
A clinical trial by Trinity College Dublin researchers has shown upadacitinib to be the most effective treatment for moderate-to-severe atopic dermatitis. The study involved 1,600 patients and found that the drug provides a substantial unmet need in treating this chronic inflammatory condition.
The University of Pennsylvania School of Medicine has doubled the percentage of Black participants in cancer clinical trials through community outreach and engagement efforts. The initiative improved access and treatment for historically underrepresented groups, with significant increases observed in non-therapeutic interventional and ...
Adaptimmune Therapeutics plc reports initial data from its Phase 2 SPEARHEAD-1 trial showing a high response rate of 41.4% for patients with synovial sarcoma, including two complete responses and encouraging initial safety and durability. The trial's results support the company's BLA submission next year.
The EBC MAIN trial found no significant difference in one-year clinical outcomes between planned single stenting and upfront two-stent techniques for true bifurcation distal left main disease. The primary composite endpoint of death, myocardial infarction, and target lesion revascularization occurred at a rate of 14.7% in the provision...
A study analyzing 105 glaucoma trials reveals significant racial and ethnic disparities in clinical trial participation. Minority groups are underrepresented in these trials, which could impact the development of effective treatments for diverse populations.
The CASTLE study investigated the role of imaging-guided percutaneous cardiac intervention (PCI) in clinical outcomes difference between ultra-thin strut biodegradable polymer sirolimus-eluting stent (Orsiro) and durable polymer everolimus-eluting stents (Xience). The results show no significant differences in target lesion failure rat...
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.