Articles tagged with Clinical Trials
The ISAR-CLOSURE trial reported that vascular closure devices (VCD) are non-inferior to manual compression in patients undergoing transfemoral coronary angiography. VCDs were found to reduce time-to-hemostasis, but had a higher rate of repeat manual compressions.
The PARTNER I trial found that TAVR demonstrated persistent mortality benefits and improved functional status after five years compared to standard therapy. This is the first long-term analysis of the randomized PARTNER I trial, which initially showed TAVR as an accepted therapy for inoperable patients with severe aortic stenosis.
The CoreValve US Pivotal trial showed improved survival benefit in patients with aortic stenosis, with low rates of all-cause mortality and major stroke after two years. The study demonstrated durable improvement in hemodynamic valve performance and low rates of moderate or severe aortic insufficiency.
The US CoreValve High Risk Trial found that transcatheter aortic valve replacement (TAVR) provided lower 12-month mortality compared to surgical aortic valve replacement (SAVR) in high-risk patients. TAVR also showed significant improvements in quality of life, with estimated gains of 0.24 life years and 0.20 quality-adjusted life years.
A pilot study found that mindfulness-based stress reduction (MBSR) significantly reduced headache duration and disability in adults with migraines. MBSR participants also experienced increased mindfulness and self-efficacy, leading researchers to conclude that the intervention is a safe and feasible therapy for migraine sufferers.
The Phase I Clinical Trial of nintedanib combined with paclitaxel showed a 50% complete response rate in early HER-2-negative breast cancer patients. The study's results have validated the safety and efficacy of the drug combination, paving the way for a large-scale Phase II Clinical Trial.
A study analyzing reanalysis of RCT data found that about one-third led to changes in findings, with some altering patient groups or treatment effects. The results underscore the importance of standardizing data sharing and reanalysis practices for individual and public health.
A new evidence-based guideline for managing sickle cell disease recommends the use of hydroxyurea and transfusion therapy for many individuals with SCD. The guideline aims to facilitate improved and more accessible care for affected individuals, despite limited high-quality evidence.
University of Alberta researchers have developed a new resuscitation method that combines oxygen flow and chest compressions, increasing survival rates for newborn babies. The technique has already helped save the lives of eight infants in a clinical trial.
A new study found that taking short walking breaks during prolonged sitting can significantly improve endothelial function and reduce cardiovascular risks. The research involved 11 healthy men who sat for three hours with or without regular breaks, showing that breaks can prevent decline in arterial function.
A phase II clinical trial combining Sorafenib and Selective Internal Radiation Therapy (SIRT) achieved improved patient survival, with median overall survival of 20.3 months for intermediate stage HCC patients. The treatment also showed promise in downstaging locally advanced HCC to potentially curative treatment.
A new breast cancer radiation trial offers once-weekly regimens with no adverse effects, resulting in better completion rates and lowered costs. The study found that this approach allows for more convenience and choice for patients, improving their ability to complete treatment, while reducing costs by up to 50-60%.
Research led by Kate Wolin found that physically active men were 13% less likely to report nocturia and 34% less likely to experience severe nocturia compared to inactive men. The study suggests that physical activity may provide a strategy for managing BPH-related outcomes, including nocturia.
The BIOPACE trial found a non-significant trend in favour of biventricular pacing over right ventricular pacing, but no significant improvement in outcomes. Patients with left ventricular ejection fraction of 50% or less did not show any benefit from biventricular pacing.
The TASTE trial found that thrombus aspiration for acute myocardial infarction (AMI) does not reduce mortality or other clinical endpoints long term. The one-year follow-up results revealed no statistically significant difference in death rates between patients who received clot aspiration and those who did not.
A new study found that complete revascularisation of all significantly blocked arteries leads to better outcomes in heart attack patients compared to only unblocking the culprit artery. Patients who underwent complete revascularisation had a lower risk of major adverse cardiac events, including death, recurrent MI, and heart failure.
A new study by the European Society of Cardiology found that the retrievable and repositionable DFM transcatheter aortic valve is effective and safe for patients with severe aortic stenosis. The device's unique features, such as retrieval and repositioning capabilities, may improve outcomes in these patients.
The NEART-HF trial found no clinical benefit of vagus nerve stimulation for heart failure patients, despite robust pre-clinical data suggesting a potential therapeutic effect. However, the treatment did show improvements in quality of life and functional classification.
The National Institute of Allergy and Infectious Diseases (NIAID) has launched an initial human safety study for an Ebola vaccine candidate. The trial is the first in a series of Phase 1 clinical trials that will examine the investigational NIAID/GSK Ebola vaccine, which is designed to induce an immune response in healthy adults.
A candidate Ebola vaccine is being tested on healthy volunteers in the UK, The Gambia, and Mali as part of an international collaboration. The phase 1 trials aim to ensure the vaccine's safety and immunogenicity before deployment to high-risk populations.
A new analysis reveals that cardiac clinic trial participants do not accurately represent the broader patient population. The study suggests using broader enrollment criteria and existing patient registries to improve clinical trial participation and generalizability.
The Children's Hospital of Philadelphia has reported successful results from 100 recent cases of fetal surgery for spina bifida, achieving comparable outcomes to the landmark MOMS trial. The study found improved rates of shunting and pulmonary edema, as well as shorter operative times and decreased transfusion rates.
A study analyzed data from a cardiovascular registry and found that clinical trial participants had lower risk profiles and more favorable prognoses compared to non-participants. The researchers noted that efforts to improve trial participation are needed to enhance the generalizability of results.
The Phase 1-2a clinical trial demonstrated a 92% objective response rate, including complete remissions in eight patients and partial remissions in four patients. Four out of seven evaluable patients with chemotherapy-refractory DLBCL achieved complete remissions, with durations ranging from 9 to 22 months.
A meta-analysis review of seven randomized control trials found no short-term pain relief and limited long-term function improvement in patients with some osteoarthritis after arthroscopic knee surgery. The study suggests that non-operative treatments should be used first for middle-aged or older patients.
A new study published in CMAJ found that arthroscopic knee surgery does not provide relief for middle-aged patients with mild osteoarthritis. The research analyzed seven randomized controlled trials and concluded that the procedure may have little to no effect on short-term and long-term outcomes.
Scientists developed a new compound that targets the 'receptor' responsible for pain caused by chili peppers. The compound, tested in clinical trials, has shown promise in treating various types of pain.
A NIH-funded study found that regular monthly blood transfusions prevented recurrent brain blood vessel blockage in children with sickle cell anemia, reducing the risk of long-term cognitive problems and poor academic performance. The study suggests early screening for silent strokes can help manage the disease and prevent complications.
A new trial suggests that regular blood transfusion therapy can significantly reduce the recurrence of silent strokes and overt strokes in children with sickle cell anemia. The study found that monthly blood transfusions reduced repeat cerebral infarcts by 58% in children with pre-existing silent strokes.
A new study reveals that better communication of basic research results during the discovery stage can lead to faster commercialization. Biotech firms often give up on inventions and transfer technology to other firms for repurposing in a new disease category, causing time losses earlier in the pathway.
Ebola treatment expert Jesse L. Goodman advocates for expedited studies of promising treatments while prioritizing patient safety. He suggests completing basic safety studies in healthy humans before treating sick patients.
The VCU Massey Cancer Center has been awarded a $4.4 million grant to establish a statewide cancer clinical trials network in Virginia, focusing on minority access and addressing cancer disparities. The network will provide cancer patients with opportunities to participate in clinical trials in their local communities.
A new experimental chikungunya vaccine performed well in an early clinical trial, eliciting neutralizing antibodies in all participants and providing durable protection for at least 11 months. The vaccine, a virus-like particle (VLP) vaccine, was delivered without an adjuvant and prompted a robust immune response.
A phase I clinical trial for MicroVAX's cancer vaccine has begun in Singapore, assessing safety and immune response against breast, prostate, colon, ovary, and lung cancers. The vaccine targets a common protein on many types of cancer.
A study found that different meta-analysis approaches can yield varying treatment outcome estimates, with some methods producing larger results. The researchers recommend assessing the robustness of their results through sensitivity analyses and comparing to other strategies.
A cluster randomized trial found that installing alcohol-based hand sanitizer dispensers in classrooms did not reduce the rate of school absences in children. The provision of hand sanitizers also did not affect the number of absences due to specific illnesses or the length of illness and absence from school.
A new clinical trial has been initiated to assess gene therapy for patients with heart pumps, with the goal of improving heart function. The trial will evaluate the effectiveness of a gene therapy that increases SERCA2a protein levels in heart muscle cells, providing potential relief from advanced heart failure.
A study of postmenopausal women found no link between bisphosphonate treatment and reduced breast cancer risk. Researchers analyzed data from two randomized trials, concluding that bisphosphonates do not protect against breast cancer in this population.
A pilot study using stem cells extracted from patients' bone marrow shows promising results in treating acute stroke. The therapy was found to be safe and improved clinical measures of disability in all five patients.
A recent study published by St. Michael's Hospital found that consuming about one serving of beans, peas, chickpeas or lentils per day can lead to increased feelings of fullness. This may help with better weight management and weight loss. Pulses have a low glycemic index and can be used to reduce animal protein and 'bad' fats in meals.
Researchers at CWRU aim to boost cancer trial participation by educating oncology nurses. The $1.6 million NCI grant-funded program will test a web-based educational tool, Oncology Nurse IMPACT, to address barriers and increase discussions about clinical trials between nurses and patients.
Researchers suggest targeting higher-motor areas instead of single targets to achieve personalized, not popular science, in stroke rehabilitation. By exploring substrates and defining successes and failures, they aim to create a shift in perspective that forces a broader understanding of brain stimulation's potential.
The NIH Stroke Trials Network brings together teams of researchers to identify priorities and provide training opportunities. Kessler Foundation & Kessler Institute participate in the network, focusing on rehabilitation and neuroimaging research.
Jigisha Patel argues that peer review should be recognized as a professional skill and that trained reviewers can improve the quality of randomized controlled trials. By implementing a 'quality assurance' symbol, trials could be identified as having undergone rigorous peer review.
A malaria vaccine has been shown to provide continued protection against clinical malaria in young infants and children, with the effect of vaccination diminishing over time. The vaccine efficacy was highest in the first 6 months after vaccination, with estimates suggesting it could have a major public health impact.
A wearable device called pupillometer has been developed to detect early signs of diabetic autonomic neuropathy by measuring pupil diameter and response time. The device is designed to be worn on glasses and may lead to far better health outcomes for people with diabetes if proven safe and effective in clinical trials.
A new epigenetic test has been validated to accurately predict prostate cancer risk, eliminating the need for unnecessary repeat biopsies. The test demonstrated a negative predictive value of 90% in one trial and 88% in another, confirming its potential as a diagnostic aid.
A phase III clinical trial shows that a combination drug therapy cures chronic hepatitis C in the majority of patients co-infected with both HIV and hepatitis C. The new all-oral regimen sofosbuvir and ribavirin has cure rates of up to 92% for treatment-experienced patients, offering a transformative step in treating this population.
Researchers at The Feinstein Institute for Medical Research have identified a brain network that measures placebo effects in Parkinson's disease patients. This breakthrough discovery has the potential to improve the accuracy of clinical trials by excluding subjects who are more likely to experience placebo effects.
Researchers have identified a distinct neurological profile associated with patients who respond favorably to sham surgery, but not those who are part of the placebo group. This new finding may help better identify efficacious treatments and limit the impact of placebo effects in clinical trials.
A recent study found that nearly 30% of completed clinical trials in the US remained unpublished after four years, threatening the validity of medical research literature. The lack of transparency was particularly pronounced among industry-funded studies and those with smaller sample sizes.
Researchers found that taking B vitamins had no effect on cognitive decline or reducing the risk of Alzheimer's disease in a meta-analysis of 11 clinical trials involving 22,000 participants. The study suggests that folic acid and vitamin B-12 can lower homocysteine levels, but not prevent the disease.
Researchers used electronic health records to monitor the impact of treatments on patients with high-risk cardiovascular disease and chronic obstructive pulmonary disease. The study found that using EHRs simplified clinical trials, saving time and money for taxpayers, while maintaining minimal patient involvement.
Researchers discovered that mice born by natural birth have a stronger immune system due to exposure to their mother's beneficial bacteria. This may lead to the development of autoimmune diseases such as type 1 diabetes and Crohn's disease.
A new study led by Dr. Barry Rovner shows that a type of rehabilitation therapy can cut the risk of depression from age-related macular degeneration (AMD) in half. The therapy, called behavior activation, helps people focus on activities they enjoy and maintain an active social life to reduce disability and prevent clinical depression.
A clinical trial shows that integrated low vision and mental health treatment can reduce depression in AMD patients by half. The approach combines behavior activation therapy with low vision occupational therapy, leading to improved functional vision and mood.
A study published in JAMA found that patients who underwent gall bladder removal without postoperative antibiotic treatment did not experience a higher incidence of infections compared to those who received antibiotics. The lack of antibiotic treatment was associated with similar length of hospital stay and readmission rates.
A study found that trials with broader age limits resulted in a significant increase in teenage cancer patients participating in clinical trials. The study showed a 13% rise in 15-19 year old patients and a 5% rise in 20-24 year olds, as well as an increase in children under 14 taking part in trials.
A large multicentre trial found no significant improvement in IVF success rates for women who underwent outpatient hysteroscopy before further IVF treatment. The study suggests that endometrial scratching, not routine hysteroscopy, may be responsible for the previously reported improvements.
The study found that the Internet-based trial was a valuable platform for conducting the randomized clinical trial and proved to be both cost and time effective. The researchers successfully enrolled 57 children from 28 states into the trial, which was completed in three months with a high completion rate.