Research on the trials that test new treatments in patients. Covers trial design, respiratory and cancer trials, screening tools, and treatment breakthroughs.
The Lung-MAP master protocol has enrolled higher percentages of patients who are older, from rural or socioeconomically deprived areas, and have Medicaid or no insurance. In contrast, patients on Lung-MAP were less likely to be female or from certain racial and ethnic groups.
A randomized clinical trial found immediate testosterone therapy significantly reduced gender dysphoria, depression, and suicidality in transgender and gender-diverse individuals. The study included 64 participants and compared immediate testosterone therapy to no treatment.
Researchers found that patients with HPV-positive cancers develop recurrent disease significantly later than those that were HPV-negative, and also are more likely to spread to the lungs. A new, highly sensitive blood test has been developed to detect cancer earlier, using a framework for combining routine blood testing and imaging.
Johns Hopkins Medicine will improve clinical trial efficiency and quality with a $24.5M grant, reducing startup time by up to 50% and enhancing participant engagement. The Trial Innovation Center will develop new methods for multicenter trials, including AI-enhanced patient screening and gamification.
A randomized clinical trial of psilocybin treatment found a clinically significant sustained reduction in depressive symptoms and functional disability. The study's findings support the potential of psilocybin as a novel intervention for major depressive disorder when administered with psychological support.
The study validates a comprehensive genomic profiling assay, NeXT Dx, which detects single nucleotide variants, indels, copy number alterations, and gene fusions. The assay demonstrates high analytic sensitivities and specificity, providing personalized recommendations critical to clinical decision-making.
Researchers found that playing a lullaby reduced pain levels in newborn infants undergoing a heel prick blood test. The study, published in Pediatric Research, suggests that recorded music may be an effective method of pain relief in newborns during minor procedures.
Researchers evaluated biochemical recurrence as a surrogate endpoint for overall survival, but found no reliable correlation. Biochemical recurrences occur early in the disease course and may impact quality of life, but high-level data tracking this is lacking.
A systematic review and meta-analysis of 18 clinical trials involving 2.1 million individuals found no significant lifetime gain from common cancer screening tests. However, colorectal cancer screening with sigmoidoscopy may have a potential benefit, according to the study.
Muvalaplin, an oral small molecule inhibitor, significantly lowered lipoprotein(a) (Lp[a]) levels in a first-in-human phase 1 study. The treatment showed promise in reducing Lp[a] levels by up to 65% without tolerability concerns.
The Cardiovascular Research Foundation has announced the TCT 2023 late-breaking clinical trials, featuring 12 studies on minimally invasive techniques, pharmaceuticals, technologies, and devices. These trials aim to improve patient outcomes in cardiovascular disease, with a focus on safety and effectiveness.
The South Carolina Clinical and Translational Research Institute's program provides early-career clinicians with the time and training needed to establish a sustainable portfolio of clinical trials. Scholars attend 'meet the expert' presentations, discuss strategies with mentors, and select suitable trials.
The CABINET trial showed statistically significant and clinically meaningful improvements in progression-free survival for patients with pancreatic and extra-pancreatic neuroendocrine tumors. The study also demonstrated a consistent safety profile for cabozantinib, with no new safety signals identified.
A recent study found that the FDA approved 65% of novel drugs in 2022 based on a single clinical trial, while only half of the available studies were classified as randomized clinical trials. This lack of transparency raises concerns about the completeness of the approval process and patient access to accurate information.
A team of Griffith University researchers has developed a novel vaccine approach using reprogrammed bacterial cells to assemble vaccine particles. The new vaccine modality has shown promise in early development and has the potential to be a game-changer for developing many vaccines globally.
Fish oil supplements often make health claims without sufficient trial data, leading to potential variability in safety and efficacy due to differing doses of eicosapentaenoic acid and docosahexaenoic acid. The study highlights the need for more rigorous regulation of these products.
Researchers developed a device to improve tissue oxygenation in breast reduction surgery, which increased oxygen levels and reduced wound breakdowns. The study showed the device was safe, easy-to-use, and well accepted by patients.
Researchers at the University of Minnesota Medical School have successfully tested a new oral antifungal therapy, Lipid Nanocrystal Amphotericin B, against cryptococcal meningitis in HIV-positive individuals. The treatment demonstrated improved survival rates and reduced toxicity compared to conventional intravenous amphotericin B.
A new study found that a simple blood test can predict the risk of progressive heart and kidney disease in people with Type 2 diabetes. The test measures levels of four biomarkers, which fell after treatment with canagliflozin, a type 2 diabetes medicine.
A phase I trial of cultivated autologous limbal epithelial cell transplantation (CALEC) has shown positive results in four patients with severe chemical burns, restoring cornea surfaces and improving vision. The treatment uses a patient's own stem cells grown on a graft, offering hope to patients with untreatable vision loss and pain a...
A randomized clinical trial found that a preoperative augmented reality walkthrough decreased preoperative anxiety compared to traditional education and handouts. However, there was no significant impact on postoperative anxiety, pain levels, or narcotic use in patients undergoing surgery.
Researchers found a 19% annual increase in Medicaid-insured cancer patients participating in publicly funded clinical trials after the Affordable Care Act Medicaid expansion. The study shows that targeted policies can increase access to health care and cancer clinical trials for those with Medicaid insurance.
Researchers found a combination of ipilimumab and nivolumab can extend progression-free survival and improve response rates in patients with resistant metastatic melanoma. The treatment showed a 37% improvement in progression-free survival compared to ipilimumab alone.
Researchers at Michigan Medicine have discovered a potential treatment for diffuse midline glioma, a type of childhood brain tumor with no effective treatments. The compound ONC201 nearly doubled survival rates in patients with the disease, and the underlying mechanism behind its success has been explained.
A novel CRISPR-based gene-editing treatment, EBT-001, effectively removes SIV from the genomes of non-human primates without off-target effects. The study's findings support the development of a cure for HIV/AIDS in humans and pave the way for ongoing clinical trials.
A new study published in Neurology found that only a small percentage of older adults with early Alzheimer's disease meet the eligibility criteria to receive new monoclonal antibody treatments. The study estimates that around 8% of people with mild cognitive impairment or mild dementia would be eligible for treatment.
A randomized clinical trial of two uterus-sparing procedures in 26 Dutch hospitals has shown that a hundred-year-old method is more effective than a newer procedure. The study found that women who underwent the older Manchester procedure had fewer complications and higher success rates after surgery.
A new study found that intensive lifestyle intervention, including weekly counseling on diet and exercise, is associated with increased employment among people with type 2 diabetes. Study participants without a college degree had even larger employment gains from lifestyle changes recommended by specialists.
A new malaria vaccine candidate has shown promising results in a cohort of Tanzanian infants, with substantial anti-RH5 immune responses achieved safely through vaccination. The vaccine targets the RH5 protein used by the malaria pathogen to invade red blood cells, providing a second line of defense against disease.
Four major clinical trial networks are partnering with the Good Clinical Trials Collaborative to enhance clinical research in low resource settings. The collaboration aims to promote principles-based guidance and education, promoting high-quality trials globally.
A randomized clinical trial found that exercise significantly reduced depressive symptoms and burnout in healthcare workers, while improving mental health. However, low adherence to exercise programming was noted towards the end of the study.
Researchers have identified a family of broadly neutralizing antibodies targeting the HIV-1 envelope protein, which may contribute to long-term remission from infection. These antibodies were found to induce the elimination of infected cells and impose a selective pressure on the virus, paving the way for new therapeutic approaches.
A preclinical study demonstrates the effectiveness of VIR-3434 in preventing viral dissemination and reducing viral particles in a mouse model for HBV/HDV coinfection. The monoclonal antibody neutralises all known genotypes of HBV and HDV, providing a potential new option for treating chronic hepatitis B and D.
Researchers have shown a positive association between added sugar consumption and an increased risk of developing kidney stones. Participants with higher intakes of added sugars had greater odds of developing kidney stones over the course of the study.
A TENS machine has shown promise as a treatment for obstructive sleep apnoea, improving breathing and reducing daytime exhaustion in patients. The device is a cheaper and less invasive alternative to CPAP, which can be uncomfortable and lead to sleep deprivation.
The Access to Advanced Health Institute has received an $18 million award from the NIH to develop a temperature-stable, single-dose chikungunya RNA vaccine candidate. The vaccine uses innovative RNA platform technology to protect against the virus, which causes debilitating joint and muscle pain in endemic areas.
Insilico Medicine's inClinico platform uses generative AI to predict Phase II to Phase III clinical trial success with an accuracy of 79%. The tool has been validated in various studies and can provide valuable insights for investors and biotech/pharma companies.
Researchers found that translating consent documents can discourage investigators from recruiting patients with limited English proficiency, contributing to low rates of participation from underrepresented groups. By relieving investigators of these costs, studies can become more inclusive and results more accurate and generalizable.
A secondary analysis of a randomized clinical trial found that exercise can significantly reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in ovarian cancer survivors. Incorporating exercise programs into standard oncology care may improve quality of life for these patients.
A large clinical trial found that surgery does not increase the number of days patients with advanced cancer are alive and out of the hospital, but improves symptoms and quality of life. Patients who underwent surgery reported fewer bowel-related symptoms after leaving the hospital.
A new study shows that estrogen receptor (ER) expression in ductal carcinoma in situ (DCIS) is multi-clonal, meaning it varies across different cells. This finding has significant clinical implications, as it may help avoid overtreatment and undertreatment in DCIS patients.
The NIH has launched phase 2 clinical trials to evaluate at least four potential treatments for long COVID, including drugs, biologics, and therapies. These trials aim to identify effective treatments swiftly by evaluating multiple treatments simultaneously.
A new phase II clinical trial will investigate the effectiveness of an accelerated course of transcranial magnetic stimulation in improving symptoms for patients with mild cognitive impairment and depression. The study aims to identify the optimal dose of stimulation needed to improve both depression and thinking difficulties in MCI, w...
A new study published in The New England Journal of Medicine found that the MIND diet had a significant improvement in cognition during the first two years, but no significant difference in three-year changes. The study enrolled 604 people with suboptimal diets and family history of Alzheimer's disease.
A secondary analysis of a randomized clinical trial found that daily low-dose aspirin increases the risk of intracranial bleeding in healthy older adults, but does not reduce ischemic stroke risk. The study's findings have particular relevance to individuals prone to developing intracranial bleeding after head trauma.
A study found that taking more daily steps improves symptoms and physical limitations for people with heart failure, with little association seen beyond 5,000 steps. Participants who increased their step counts experienced improved symptom control and physical function.
A clinical trial found that interferon can help reduce the spread of COVID-19 from a positive person to their household contacts. The study tracked 1,172 participants and showed that interferon treatment reduced viral load in households with high viral loads. However, it did not reduce disease severity.
Researchers found that a combination of exercise and cognitive training significantly improved cognition in adults with mild cognitive impairment. Vitamin D supplementation had no impact on cognitive function.
A clinical trial found that hydroxyapatite toothpaste is equally effective in preventing cavities as fluoride toothpaste. The study involved 189 adults who used either hydroxyapatite or fluoride toothpaste for 18 months, with no significant difference in efficacy between the two groups.
In a phase 3 clinical trial, donanemab significantly slowed clinical progression in patients with low/medium tau and high tau pathology. The treatment cleared brain amyloid plaque, demonstrating its potential to slow Alzheimer disease progression.
A new combination treatment of GVAX vaccine, nivolumab, and urelemab has shown to increase the amount of cancer-killing immune cells in tumors and appear effective when given two weeks prior to surgery. The study found a median disease-free survival of 33.51 months and a median overall survival of 35.5 months.
The PhRMA Foundation is launching a grant program to fund research on the use of digital health technologies in diverse populations. The program aims to advance regulatory decision-making and promote health equity. Eligible applicants must submit letters of intent by September 29, 2023.
Researchers investigated the effects of meditation training and non-native language training on cognition in older adults. Despite initial expectations, these interventions failed to demonstrate salutary cognitive effects, casting doubt on their potential as a preventative measure for aging-related decline.
A new study by Bentley University reveals the NIH's significant investment in pharmaceutical innovation, with $8.1 billion spent on phased clinical trials between 2010-19. The funding represents only ~10% of reported industry costs for these trials, highlighting the public sector's limited contribution to drug development.
A large-scale study found that exercise programs for dialysis patients lead to significant improvements in physical fitness, quality of life, and reduced hospital stays. Personalized exercise plans showed low costs per training unit, making them a viable option for standard healthcare coverage.
A randomized clinical trial found that low-dose atropine eye drops did not slow myopia progression or axial elongation in US school-age children. The results suggest that atropine, 0.01%, eye drops are not effective for controlling myopia in this population.
A low-cost version of ketamine has shown strong results in treating treatment-resistant depression, with over 20% participants achieving total remission and a third experiencing symptom improvement. The study's findings bring definitive evidence to the field, which can be more affordable than existing treatments.
A new study by researchers at Dartmouth Cancer Center shows that a combination of estrogen and PARP inhibitors can effectively treat advanced ER+ breast cancer by damaging cancer cells and preventing DNA repair. The treatment strategy has been shown to be effective regardless of BRCA1 or BRCA2 genetic mutations.
Researchers at Mass General Cancer Center treated 16 patients with a BRAF/MEK inhibitor, resulting in a 91% reduction in tumor size and complete response in all patients who received one or more cycles of therapy. The treatment showed unprecedented success in targeting brain tumors using precision medicine approaches.
A Phase 3 study led by Massachusetts General Hospital found cytisinicline to be effective in reducing nicotine dependence and cravings, with impressive results. The medication was also well-tolerated, with no serious side effects reported, offering a new potential treatment option for smoking cessation.