Research on the trials that test new treatments in patients. Covers trial design, respiratory and cancer trials, screening tools, and treatment breakthroughs.
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.
The RACE trial demonstrated that adding Eltrombopag to standard immunosuppressive treatment increases response rates in patients with Severe Aplastic Anaemia. The study found significant improvements in complete response rates, sustained at 6 months, and showed Eltrombopag was generally well-tolerated.
A new palliative care model, known as Short-Term Integrated Palliative Care (SIPC), has been shown to improve quality of life for patients with long-term neurological conditions while reducing costs. The study found no significant difference in patient-reported outcomes between SIPC and standard care.
Researchers developed computational models of patients with COVID-19 to enhance assessment and analysis tools in CT and radiography. These models were combined with imaging simulators for COVID-19 studies, yielding realistic results.
A randomized trial compared remdesivir with standard care in patients with moderate pneumonia and SARS-CoV-2 infection. Remdesivir treatment resulted in improved clinical status, with no increased risk of adverse events.
A nationwide study of convalescent plasma as a treatment for COVID-19 will be conducted at Vanderbilt University Medical Center. The randomized trial aims to test whether infusions of plasma can help hospitalized patients with COVID-19.
A clinical trial found that consuming 44mg of proanthocyanidins (PACs) per day in cranberry juice resulted in a 20% reduction in H. pylori infection rates in Chinese adults. The study suggests that twice-daily consumption of this specific amount of PACs may be an effective natural management strategy for adults infected with H. pylori.
The Phase 2 clinical trial will evaluate the safety, immunogenicity, and efficacy of NVX-CoV2373 in approximately 2,650 healthy adults and 240 medically stable HIV-positive adults. The trial aims to provide early data on vaccine protection against Covid-19 in South Africa.
Researchers identified a link between female authors and increased enrollment of women in heart failure clinical trials. The study, published in Circulation: Heart Failure, found that clinical trials with female first or senior authors had a higher proportion of enrolled female participants.
A clinical trial by Oregon State University found that lipoic acid supplements caused significant weight loss and fat reduction in overweight but otherwise healthy participants. The study also showed improvements in inflammation markers and oxidative stress, with notable benefits for women and heaviest participants.
Majority of patients in remdesivir trials were Caucasians, raising concerns about medication efficacy in people of color. The study emphasizes the need for diverse clinical trial participants to accurately represent the US population and inform treatments.
A new study reveals racial disparities in high-cost proton radiotherapy for childhood cancer treatment, with Black and low-income children facing barriers to access. The research highlights the urgent need for equitable healthcare policies to ensure all children receive quality cancer care regardless of their race or socioeconomic status.
A study published in The Lancet found that plaster casts are as effective as surgery in healing scaphoid waist fractures in the wrist. Patients who received a plaster cast showed similar outcomes to those who underwent surgery, with no significant difference in pain, function, or complications.
A Phase 2 clinical trial is testing the safety and efficacy of synthetic monoclonal antibodies to treat COVID-19. The study aims to reduce the duration of symptoms and increase the proportion of participants with undetectable virus in nasopharyngeal swabs.
The ACTIV-3 clinical trial tests the safety and efficacy of a monoclonal antibody treatment in hospitalized COVID-19 patients. The trial aims to enroll approximately 300 volunteers with mild to moderate symptoms, who will receive either an intravenous infusion of LY-CoV555 or a saline placebo infusion.
A potential treatment for yellow fever has shown promise in early-stage clinical trials in Singapore, using a novel approach to develop an engineered monoclonal antibody that targets the virus. The therapy was developed in seven months, significantly reducing the time required for drug development.
A novel cell therapy using patient T cells has shown preliminary effectiveness in treating relapsed or treatment-resistant multiple myeloma. The treatment, which is safer than existing CAR T cells, improved survival rates and objective clinical responses in patients with active disease.
GW University will participate in a Phase 3 clinical trial of the mRNA-1273 vaccine to test its safety and efficacy in humans. The trial aims to enroll 500 participants, including those at high risk for severe illness due to age or comorbidities, to develop a vaccine that can effectively protect these populations.
A Phase 3 clinical trial has begun to test the safety and efficacy of the mRNA-1273 vaccine in preventing symptomatic COVID-19. The trial enrolls approximately 30,000 adult volunteers and aims to determine if the vaccine can provide long-lasting protection against the virus.