Articles tagged with Clinical Trials
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.
Changing healthcare payment for one insurer can impact patients covered by others, a nationwide randomized trial suggests. The study found lower hospital readmissions and care intensity among TM patients and those with private insurance through Medicare Advantage.
The Predictive Safety Testing Consortium and Duchenne Regulatory Science Consortium have developed a glutamate dehydrogenase (GLDH) biomarker to detect drug-induced liver injury in patients with inherited muscle disorders. The FDA has agreed to accept the Qualification Plan for GLDH as an important and accurate measurement of DILI.
A clinical trial by Newcastle University found that levothyroxine does not improve cardiac function in patients who have had a heart attack and are suffering from mild or subclinical hypothyroidism. The treatment, which is commonly recommended for these patients, may actually be of no benefit.
A USC-led team found a fasting-mimicking diet combined with hormone therapy may increase the power of cancer hormone drugs and delay resistance in small clinical trials and mouse studies. Researchers observed reduced insulin, IGF1, and leptin levels, leading to potential anti-cancer activity.
The National Pediatric Rehabilitation Resource Center aims to promote clinical trials research in pediatric rehabilitation. The center will fund up to $150,000 per year for pilot studies and offer educational resources to support the growth of the field.
A Chinese phase 2 trial found that a recombinant adenovirus type-5-vectored COVID-19 vaccine is safe and induces an immune response in over 500 participants. The trial, which evaluated the safety and immunogenicity of the vaccine candidate, provides data on the efficacy of the vaccine against SARS-CoV-2 infection.
The phase 1/2 trial found the vaccine induces strong antibody and T cell immune responses, and causes minor side effects more frequently than a control group. Further clinical studies are needed to confirm the vaccine's effectiveness in protecting against SARS-CoV-2 infection.
A new randomized trial published in Annals of Internal Medicine found that hydroxychloroquine showed no benefit in reducing symptom severity or duration in outpatients with early, mild COVID-19. The study suggests that the treatment may not be effective in populations at higher risk for severe COVID-19.
A large international study found that starting dialysis early in critically ill patients with acute kidney injury did not reduce mortality after three months. The accelerated renal-replacement therapy strategy did not show significant difference in survival between the two treatment approaches.
A recent study by UNLV researchers found that while the success rate of Alzheimer's drugs in development remains low, there is increased hope due to repurposed agents and advancements in biomarkers. The team also emphasized the critical role of patient participation and the need for investment in new therapies.
A major multinational trial found that fast-tracking dialysis for critically ill patients with severe acute kidney injury did not improve outcomes. The study included over 3,000 patients in 168 hospitals across 15 countries and suggested a more conservative approach to treatment may be warranted.
Researchers at UC San Diego highlight nanotechnology's role in COVID-19 vaccine development, including peptide-based vaccines and molecular farming. The first candidates in clinical trials utilize novel nanotechnologies.
The Phase 1 trial of mRNA-1273 vaccine showed neutralizing antibody activity in healthy adults, with high levels observed after two doses. The vaccine was generally well-tolerated, with side effects including fatigue and pain at the injection site.
A 10-year study found that radiotherapy in five larger doses, rather than daily doses, is equally effective and safe in the long term. This approach benefits patients with low risk of relapse who cannot tolerate daily radiation due to frailty or chronic conditions.
The review analyzes the design and implementation of RCTs for COVID-19 treatments, identifying common characteristics and limitations. Key takeaways include the importance of standardized reporting and the need for further research on treatment outcomes.
The National Institutes of Health has established a new clinical trials network to enroll thousands of volunteers in large-scale clinical trials testing various COVID-19 vaccines and monoclonal antibodies. The COVPN will leverage existing infrastructure and engage communities to secure participants for late-stage clinical trials.
Tofersen, an experimental drug for a rare inherited form of amyotrophic lateral sclerosis (ALS), has shown early promise in a phase 1/phase 2 clinical trial. The study found that the drug is generally well-tolerated and lowers levels of a disease-causing protein in people with SOD1 ALS.
The UCSC-led research center aims to understand the basic biological mechanisms of botanical natural products and address challenges in studying their variability and clinical trial design. The center will use innovative screening platforms to measure the effects of complex botanical natural products on cells.
A clinical trial found that breast augmentation with ASC-enriched fat grafts resulted in significantly better outcomes compared to non-enriched grafts. The study showed improved retention rates and histological appearance of the grafts, making ASCs a promising tool for increasing graft success.
A randomized trial of a multifactorial fall injury prevention strategy found an approximately 8-10% reduction in serious fall injuries, lower than expected. The study enrolled 5,451 people aged 70 and older and evaluated the effectiveness of a nurse-delivered intervention.
A large randomized trial has found that endometrial scratch is not beneficial in women having their first cycle of IVF. The study involved over 1000 women under 37 years old and showed no significant difference in live birth rates between those who received endometrial scratch and those who did not.
A clinical trial is underway to test an immune booster, IMM-101, in cancer patients to prevent severe COVID-19. The study aims to boost the innate immune system and protect vulnerable populations from lung infections.
PRRT is an approved treatment modality for gastroenteropancreatic neuroendocrine tumours, particularly in midgut NETs. In Australia, PRRT is used more widely than previously thought, despite limited Phase III trial data for lung NETs.
Plant pathologists at Auburn University conducted a field trial to assess the economic damage of reniform nematodes on cotton yields. The study found that cotton yields were 50% lower in fields infested with the nematode compared to clean fields.
A pooled analysis of DEFINE FLAIR and iFR SWEDEHEART trials reveals similar safety profiles for iFR and FFR in deferring revascularisation. However, FFR-based deferral shows a strong interaction with age, which may be related to varying age-related responses to adenosine.
A meta-analysis of randomized trials found routine revascularization associated with lower non-procedural MI and unstable angina risk, but higher procedural MI rates. The benefits of routine revascularization compared to medical therapy are still uncertain.