Articles tagged with Clinical Trials
The TARGET FFR trial found that a physiology-guided incremental optimization strategy (PIOS) reduced the proportion of patients with a final post-PCI FFR ?0.80, while also improving mean Coronary Flow Reserve. The study's results suggest potential benefits for PCI outcomes.
The MITHRAS trial found that interventional closure of an iatrogenic atrial septal defect (iASD) driven by transcatheter mitral valve repair was not superior to conservative medical treatment. The study also revealed that the presence of a persistent iASD is associated with increased long-term mortality and morbidity following TMVR.
Researchers from the University of Minnesota developed a bimodal neuromodulation treatment using sound and electrical stimulation to reduce tinnitus symptoms. The study, published in Science Translational Medicine, showed significant improvements in symptom severity for 86% of participants after 12 weeks of treatment.
A new self-expanding bioprosthetic valve used in TAVR failed to demonstrate non-inferiority compared to an existing valve. The SCOPE II Trial found increased rates of cardiac death and moderate-severe aortic regurgitation with the new valve.
The REFLECT II trial evaluated the safety and effectiveness of TriGuard 3, a self-stabilizing cerebral embolic deflection filter, in patients undergoing TAVR. The device met the primary safety endpoint, but did not demonstrate superiority for reducing ischemic stroke or larger lesions.
A Phase 1/2 randomised controlled trial found the vaccine candidate BBIBP-CorV is safe and induces an immune response in healthy volunteers. The study detected antibody responses in all recipients by day 42 after vaccination, and was well-tolerated with no severe adverse reactions reported.
A new study found that personal and psychological characteristics significantly impact progress in workplace wellness programs. The research suggests that tailoring nudges to an individual's behavior profile can unlock full potential, leading to improved outcomes. For some groups, ongoing incentives may be necessary to sustain motivation.
A randomized clinical trial found that different fitness strategies were effective for distinct subgroups of participants based on their personality and behavioral characteristics. These subgroups included extroverted and motivated individuals, less active and less social participants, and those who were less motivated and at-risk.
The PROSPECT ABSORB trial found PCI safe with favorable long-term outcomes for non-flow-limiting vulnerable plaques. Follow-up lumen areas were substantially enlarged in BVS-treated lesions compared to GDMT alone.
The COMBINE (OCT-FFR) trial found that the presence of TCFA is a strong predictor of future MACE, despite lack of ischemia. Combining FFR and OCT can improve accuracy of high-risk lesion identification in patients with diabetes.
The NIH has launched the ACTIV-5 Big Effect Trial to determine whether certain approved therapies or investigational drugs show promise against COVID-19. The study will enroll adult volunteers hospitalized with COVID-19 at up to 40 US sites and test three investigational treatments against a placebo.
A Phase I trial found neoadjuvant combination immunotherapy with tremelimumab and durvalumab showed early signs of activity in patients with high-risk disease, with a pathologic complete response rate of 37.5%.
Researchers at NHGRI conducted a study to better understand the needs of patients with sickle cell disease regarding genome editing clinical trials. Participants showed higher genetic literacy levels than expected, but emphasized the need for accessible information about risks and benefits.
UT Southwestern Medical Center's COVID-19 adjustments streamlined clinical trials, allowing for remote consents and telehealth visits. A survey of UTSW clinical research professionals found positive experiences with these changes, with over 90% supporting continued use after the pandemic ends.
Researchers found that antibiotics were not worse than surgery in terms of overall health status, allowing most people to avoid operations. Patients treated with antibiotics often returned home faster but missed less time from work and school.
The SWOG Cancer Research Network will share innovative approaches to cancer care, including telemedicine and quality improvements, in response to the COVID-19 pandemic. The network's trials have led to significant advancements in cancer treatment and patient outcomes.
A single fungicide application at the silking stage provides the best foliar disease control in Kentucky corn crops, according to research by Carl Bradley and colleagues. This approach is more cost-effective than sequential applications, allowing farmers to improve their return on investment.
The CODA Trial found that antibiotics were not worse than surgery in measuring overall health status, allowing most people to avoid operations in the short term. Patients treated with antibiotics more often returned to the emergency department but missed less time from work and school.
Influenza vaccination has shown promise in preventing cardiovascular complications from COVID-19, particularly in high-risk patients. Three ongoing trials are evaluating the cardioprotective effects of different influenza vaccine formulations and may inform future efforts to develop targeted interventions.
Researchers found that minority-serving hospitals offer a strong level of evidence-based care for early-stage breast cancer, with similar rates of following recommended surgical procedures as non-minority hospitals. However, disparities exist in access to high-quality care and adherence to treatment guidelines among minority-serving ho...
A new investigation by Science reveals that the FDA's enforcement of clinical trial regulations is often light-handed, slow-moving, and secretive. The agency rarely levels sanctions or disqualifies scientists from clinical research, and cases are frequently resolved based on unverified claims.
A Phase 1 trial of an investigational mRNA COVID-19 vaccine has shown that the vaccine is well-tolerated and generates a strong immune response in older adults, with comparable efficacy to younger age groups. The study enrolled 40 healthy volunteers aged 56-71 years, who received two doses of the vaccine.
A randomized clinical trial found daily hydroxychloroquine did not prevent SARS-CoV-2 infection in hospital-based healthcare workers. The trial was terminated early due to lack of efficacy.
The National Institutes of Health has awarded grants to support researchers' efforts in using tiny, bioengineered models of human tissues and organ systems to study diseases and test drugs. The goal is to develop ways to predict which patients are most likely to benefit from an investigational therapy prior to initiating clinical trials.
Insilico Medicine will showcase its latest AI advancements in drug discovery and productive longevity at the Leveraging Intelligent Tech for Drug Development Forum. The company's work on AI-generated molecular structures, synthetic biological data, and clinical trial prediction has garnered significant attention and funding.
Researchers at MUSC are using new technologies to conduct remote smoking cessation clinical trials, reaching smokers in rural areas and beyond. With electronic consent and smartphone-enabled devices, participants can complete trials from home, providing more representative data.
A new TB vaccine developed by Dartmouth's Geisel School of Medicine has shown promising results in a Phase 2 trial, inducing immune responses against the disease. The vaccine was safe and well-tolerated, with minimal local reactions, and may prevent TB disease by inducing a favorable immune response.
A study published in JAMA Internal Medicine reveals that older persons are highly likely to be excluded from COVID-19 clinical trials, despite accounting for 30-40% of cases and 80% of deaths globally. The exclusion poses a risk to the effectiveness and safety of treatments for older adults.
Randomized clinical trials for COVID-19 treatments and vaccines often exclude older adults, according to a new study. The study found that the likelihood of excluding older persons is significant in these trials, raising concerns about equity and inclusivity.
The FDA has approved Nucala for use in treating patients with hypereosinophilic syndrome, a life-threatening group of blood disorders. The drug reduces disease flares and improves health without substantial side effects.
A randomized clinical trial found that restricting daily eating to between 12 pm and 8 pm resulted in significant weight loss among participants. The study also showed improvements in metabolic markers, suggesting a potential therapeutic strategy for obesity.
A new drug, vamorolone, has shown promise in reducing side effects associated with current steroid treatments for Duchenne muscular dystrophy. Interim results from a 24-month clinical trial suggest that vamorolone may retain or improve the therapeutic benefits of steroids while minimizing risks.
A fourth Phase 3 clinical trial has begun enrolling adult volunteers to evaluate the investigational Janssen COVID-19 vaccine. The trial aims to assess the vaccine's ability to prevent symptomatic COVID-19 after a single dose regimen.
A new Mayo Clinic study found that clinical oncologists are less informed about the federal Right to Try (RTT) law, citing concerns over patient safety and regulatory burden. The study also revealed that most oncologists had limited familiarity with RTT despite having experience with FDA's Expanded Access Programs.
The National Institutes of Health (NIH) is expanding two randomized, placebo-controlled clinical trials to evaluate the effectiveness and safety of convalescent plasma as a treatment for patients hospitalized with COVID-19. The trials aim to assess clinical improvement measures and resource needs, such as ventilators.
A pioneering study by Massachusetts General Hospital researchers found light therapy to be safe and measurable in the brain, showing promise as a treatment for TBI. The study included 68 patients with moderate traumatic brain injury and found statistically significant differences in myelin integrity surrounding neurons.
Researchers found that a hybrid strategy combining electronic medical records with postal mailings is more effective than traditional methods in recruiting diverse participant populations. This approach increased participation among underrepresented groups, including Black participants and women, while being cost-effective.
A randomized clinical trial compared two smartphone apps for helping smokers quit, with one approach using gamification and the other leveraging cognitive behavioral therapy. The study found that both apps were effective in reducing cigarette use, but the gamified app had a higher quit rate at 6-month follow-up.
A VCU study reveals an experimental cancer drug called AR-12 may be effective against SARS-CoV-2, inhibiting viral infection and replication. The oral treatment has shown promise in previous studies, including against other viruses like Zika and influenza.
A phase 3 trial found that combining nivolumab and cabozantinib was superior to sunitinib for progression-free survival, overall survival, and response rate in patients with metastatic kidney cancer. The treatment reduced the risk of progression or death by almost 50%.
The University of Montana has received a five-year, $33.4 million award from the National Institutes of Health to develop and conduct clinical trials for opioid vaccines. The UM vaccine research team will advance lead opioid vaccine candidates to Phase I human clinical trials with funding from the NIH HEAL Initiative.
A study presented at ESMO 2020 found significant variations in access to cancer medicines and clinical trials across European countries. Western European nations tend to have more clinical trials, while Eastern and Central European countries face barriers due to limited infrastructure and resources.
A Phase II trial found that a combination of ipilimumab and nivolumab generated durable responses in 25% of patients with metastatic castration-resistant prostate cancer. The treatment achieved disease control in 46.9% of patients, with median progression-free survival of 5.5 months.
Researchers tested the ReWalk ReStore soft robotic exosuit for safety, reliability, and feasibility in post-stroke rehabilitation. The device improved gait patterns and walking speeds, with over a third of participants achieving significant increases in unassisted walking speed.
The International Vaccine Institute (IVI) is preparing clinical trial sites for COVID-19 vaccine efficacy trials in four African and Asian countries with the support of the Bill & Melinda Gates Foundation. IVI aims to bolster in-country capacity by 4Q2020 to ensure these sites are prepared for efficacy trials.
Two Russian phase 1/2 trials found that vaccine candidates induced an antibody response and elicited a T cell response in all participants within 28 days. The trials, involving 76 healthy adults, showed no serious adverse events over 42 days, paving the way for large-scale use of the vaccines.
Two Russian vaccine trials found no serious adverse effects and induced an immune response in participants. The trials used a two-part vaccine with adenovirus vectors and demonstrated a good safety profile.
A new surgical trial found excellent outcomes for patients with obstructive sleep apnea who couldn't use CPAP masks, with significant reductions in night-time apnoea events and improvements in daytime sleepiness. The procedure combines palate surgery with a low-risk tongue procedure to create an improved airway.
A randomized clinical trial found that intravenous dexamethasone plus standard care increased the number of days patients were alive and free from mechanical ventilation. The study involved 299 patients with moderate or severe acute respiratory distress syndrome due to COVID-19, and the results suggest a potential treatment benefit.
A randomized clinical trial found that intravenous hydrocortisone improved 21-day organ support-free days in patients with severe COVID-19. The study, stopped early due to another trial's results, investigated the effectiveness of hydrocortisone on mortality and organ support.
Vanderbilt University Medical Center is launching a clinical trial of promising treatments for COVID-19 in the outpatient setting as part of the ACTIV-2 protocol. The study aims to find a safe and effective treatment for non-hospitalized patients with COVID-19.
A recent clinical trial has shown that an experimental medication, AMX0035, can slow the progression of Amyotrophic lateral sclerosis (ALS) by improving functional outcomes. The study involved 137 participants with ALS and demonstrated a significant slowing of disease progression.
A new international study published in JAMA found that treating critically ill COVID-19 patients with the steroid hydrocortisone improves their chances of recovery. The study showed a 93% chance of better outcomes for patients treated with a fixed dose of hydrocortisone.
A randomized clinical trial in France evaluated the effect of low-dose hydrocortisone on ICU patients with COVID-19-related acute respiratory failure. The study found that hydrocortisone treatment reduced mortality and decreased the need for respiratory support among critically ill COVID-19 patients.
A Yale clinical trial is using an automated bilingual computerized approach to screen for and intervene with high-risk drinking behaviors among Latino patients in emergency departments. The study aims to explore unique differences within Latino subgroups and advance understanding of addressing health disparities in alcohol use disorders.
A clinical trial found that patients with IDH-mutant high-risk LGG, regardless of codeletion status, receive a survival benefit from adding postradiation chemotherapy. The study supports the use of WHO-defined molecular subgroups in predicting response to treatment.
The DAPA-CKD trial found that dapagliflozin reduced the risk of worsening kidney function, death from kidney disease, or hospitalization for heart failure and cardiovascular events in patients with chronic kidney disease. The study also showed a significant reduction in all-cause mortality.
The EMPEROR-Reduced trial found that empagliflozin significantly reduced the risk of cardiovascular death or hospitalization for heart failure, as well as adverse renal outcomes. By extending benefits to higher-risk patients, this trial supports the use of SGLT2 inhibitors in heart failure treatment.
The HOME-PE trial found that home management is safe and effective for selected patients with acute pulmonary embolism. Using the Hestia criteria or sPESI score, over 30% of patients can be treated at home with a low rate of complications.
The EXPLORER-HCM trial demonstrated that mavacamten significantly improves exercise capacity, symptoms, and quality of life in patients with obstructive hypertrophic cardiomyopathy. The treatment was found to be generally well-tolerated, with a favorable safety profile.