Articles tagged with Clinical Trials
A study found that 1/3 of cancer drugs with accelerated approval fail to show clinical benefit in post-approval trials yet remain recommended in clinical guidelines. Researchers call for reforms to improve clarity on FDA approvals and withdrawals.
The first-in-human clinical trial for a vaccine to treat opioid use disorders has enrolled its first patients. The vaccine, developed by researchers at the University of Minnesota Medical School, aims to selectively prevent the euphoric and toxic effects of oxycodone.
A novel COVID-19 vaccine candidate demonstrates high efficacy in preclinical models by stimulating the immune system and inducing a robust neutralizing antibody response. The vaccine protects against reinfection and provides better protection than natural immunity, making it a potential supplement to existing vaccines.
A Northwestern University study found that unionizing resident doctors does not reduce burnout, but provides additional benefits such as more vacation time and housing stipends. The study suggests that improving resident wellness requires a program-by-program approach, with implementing wellness toolkits being a promising solution.
The CAPTIVA trial will enroll 1,683 patients with symptomatic intracranial arterial stenosis and determine if two new prospective therapies are more effective than aspirin plus clopidogrel at reducing the risk of a second stroke. Intensive medical management and lifestyle modifications will also be provided to all patients.
A new analytics platform, RDCA-DAP, will be launched to accelerate rare disease treatment innovation by hosting and standardizing rare diseases data. The platform is expected to empower patients and families to drive innovation in the field.
A modified chemotherapy regimen for Burkitt lymphoma has been developed, combining CODOX-M and IVAC with rituximab, to reduce toxicity and improve survival rates. The study found a higher overall survival rate and lower frequency of severe side effects compared to standard regimens.
Researchers from Florida Atlantic University's Schmidt College of Medicine review recent randomized trials, concluding that hydroxychloroquine poses significant harm in treating COVID-19. The study suggests a halt on prescribing the medication, recommending vaccination and masking instead as effective public health strategies.
Researchers from the University of South Australia are conducting a new study to understand what works well and what needs improvement in clinical trials for cancer patients. The study aims to identify barriers to trial participation and inform best practice, ultimately improving access to clinical trials and systems across Adelaide.
A new combination treatment has shown significant tumor shrinkage and prolonged survival in patients with metastatic uveal melanoma. The treatment, which targets HDAC and PD-1 proteins, was found to work better in tumors with active BAP1 genes, a key discovery that may lead to improved survival rates.
The University of Kentucky Center for Clinical and Translational Science has received a $23.5 million award to support groundbreaking health care innovations in Kentucky. The center has successfully catalyzed clinical and translational discoveries, including COVID-19 vaccine trials, with continuous funding since 2011.
A telephone-delivered nursing care strategy combining heart failure care management with depression treatment improved patients' clinical outcomes. Patients receiving 'blended' collaborative care showed better mental health-related quality of life, including improved mood and reduced limitations in social activities.
A large-scale international study found that edoxaban is non-inferior to warfarin for efficacy in preventing adverse events, but led to higher bleeding complications. The trial suggests that treatment with edoxaban can be valuable in managing AF patients after TAVR, especially when a lower dose of edoxaban is used.
A large clinical trial has identified empagliflozin as a treatment option for heart failure with preserved ejection fraction, reducing risk of hospitalization or death by 21 percent. The drug also showed fewer symptoms and mild side effects.
The EMPEROR-Preserved trial found that empagliflozin reduced the risk of a composite of cardiovascular death or hospitalisation for heart failure in patients with heart failure and a preserved ejection fraction. The study showed that empagliflozin was effective across all prespecified subgroups, including those with or without diabetes.
Researchers compared the accuracy of two types of fecal tests for detecting colorectal cancer, finding that both types are reliable when thresholds are adjusted. The study suggests that health providers should select the best type of test based on specific demands in screening settings.
A Rutgers study found that testing for specific inflammatory proteins can help diagnose the earlier onset and progression of Alzheimer's disease. The researchers identified two proteins, TNFR1 and TREM2, which are associated with slower decline in early-stage Alzheimer's, while another protein is only useful once dementia sets in.
A clinical trial has shown that a triple combination therapy consisting of elexacaftor, tezacaftor, and ivacaftor is safe and effective in cystic fibrosis patients with rare genetic defects. The treatment improves CFTR function, lung function, and quality of life in these patients.
A systematic review of federally funded cardiovascular disease trials found that most failed to recruit adequate numbers of Black participants. Despite efforts to improve diversity, enrollment rates have not changed over time, with nearly a quarter of trials not specifying a target percentage of Black enrollees.
A new study suggests that a treatment for canine glioblastoma may also be effective in humans, with some dogs experiencing significant tumor shrinkage. The treatment uses an immunotherapy drug called STING agonist, which induced a robust immune response against cancer cells.
The International Vaccine Institute (IVI) has initiated a Phase II/III clinical trial for the Bharat Biotech Chikungunya vaccine candidate BBV87, evaluating its safety and immunogenicity in healthy adults across five countries. The study aims to develop an affordable vaccine with the aim of achieving WHO prequalification.
The HIPGEN study, a multinational trial, investigates the efficacy and safety of allogeneic placenta-expanded adherent stromal cells to improve recovery after hip fracture arthroplasty. The trial aims to combat immobility and associated problems by strengthening periarticular hip musculature.
Researchers from Okayama University conducted a randomized trial to assess the benefits of interventions for early cancer screening in patients with schizophrenia. The study found that 47.1% of counseled patients underwent colorectal cancer screening, compared to 11.8% of those receiving only usual treatment.
A new study published in The New England Journal of Medicine found that early administration of convalescent plasma did not prevent COVID-19 disease progression in high-risk patients. Despite the strategy's potential, the study suggests that it is not a viable approach to reduce illness severity.
Black, Hispanic, Indigenous and Asian Americans remain underrepresented in pancreatic cancer clinical trials, despite federal mandates. The lack of diversity hurts patients and science alike, with racial and ethnic minorities accounting for a disproportionate burden of pancreatic cancer cases.
A new study reanalyzes the Sorby vitamin C experiment, a landmark trial that determined the minimum vitamin C requirements for preventing scurvy. The analysis suggests that the recommended daily intake of 45mg may be too low to prevent weak scar strength.
A multicenter randomized trial showed acupuncture improved symptoms of moderate to severe CP/CPPS, with effects lasting over 24 weeks. Acupuncture was more effective than sham therapy in reducing symptoms and improving quality of life for men with chronic prostatitis/chronic pelvic pain syndrome.
Researchers found that removing race-based adjustments from equations estimating kidney function could make Black patients ineligible for cancer treatments and lower their doses. The analysis showed that Black patients in the US are more frequently diagnosed with cancer and are more likely to die from it than white Americans.
A new monoclonal antibody called CIS43LS safely prevented malaria for up to nine months in a small clinical trial. The study builds on encouraging early results and will inform additional research to confirm and extend the finding.
A first-of-its-kind study from the University of Pennsylvania School of Nursing clarifies the post-trial needs of patients who withdraw from cancer clinical trials. The study defines what constitutes responsible transitions when patients exit CCTs, providing insights into patient experiences and care after withdrawal.
SK bioscience's GBP510 vaccine candidate has shown promising safety and immunogenic response in Phase I/II clinical trials. IVI will partner with SK on global Phase III trials to accelerate development and WHO approval of the vaccine.
The NIH has launched a pilot study to assess the antibody response of kidney transplant recipients to a third dose of an mRNA COVID-19 vaccine. The trial aims to determine if a third dose can overcome the immune suppression caused by lifelong immunosuppressive therapy in this population.
The study analyzed 444 cancer treatment trials and found that 8.4% of patients enrolled were in the 15-39 age range, more than double the national average. AYA patients were also found to be more racially and ethnically diverse than older patients.
The article considers the ethical issues surrounding enrolling children with neurodevelopmental conditions, such as autism spectrum disorder and fragile X syndrome, in clinical trials. Parents may face difficult decisions about whether to enroll their children due to concerns about potential loss of positive aspects of their condition.
A phase II clinical trial of remetinostat gel found a 69.7% response rate to the topical treatment, with complete responses observed across multiple BCC subtypes, and a durable response in nodular BCCs.
Cardiovascular diseases affect women just as much, if not more, than men, yet current guideline-directed therapies are based on data predominantly including male patients. The European Society of Cardiology calls for increased diversity in research teams and targeted interventions to boost attendance.
A study from the University of South Carolina's Environmental Health & Disease Laboratory found that andrographolide successfully restored bacteriomes and viromes, increasing beneficial bacteria and decreasing harmful bacteria. The treatment also decreased gut inflammation and neuroinflammation in veterans with Gulf War Illness.
A new clinical trial will test a simple breathing exercise for adults with obstructive sleep apnea and hypertension. The study aims to reduce blood pressure and improve cardiovascular health through inspiratory muscle training.
Researchers discovered that almost half of patients who received personalized information about community resources shared them with at least one other person. Individuals in poorer health were more likely to report sharing the information, and those who visited or used a resource on their list were also more likely to share it.
A randomized clinical trial found that graphic warning labels on cigarette packaging changed the perception of US smokers, making them more likely to recognize the negative consequences of tobacco use and consider quitting. However, it did not significantly increase quit attempts or reduce nicotine addiction.
A clinical trial shows that full-dose blood thinner treatment reduced the need for organ support and improved hospital outcomes in moderately ill COVID-19 patients. However, this benefit was not seen in critically ill patients requiring intensive care.
Despite initial drops in enrollment, cancer clinical trials in the US showed significant resilience during the 2020-2021 COVID-19 pandemic. Treatment trial enrollments remained remarkably stable, while cancer control and prevention studies were disproportionately affected.
Patients with cancer who experience clinically significant fatigue before treatment have shorter overall survival times and more side effects. Researchers analyzed four clinical trials testing lung and prostate cancer treatments, confirming that pretreatment fatigue may be an important prognostic factor in oncology.
The NIH has launched Outreach Pro, an online tool designed to improve recruitment of underrepresented populations in Alzheimer's clinical trials. The platform provides customizable participant recruitment communications and culturally appropriate outreach materials.
Researchers at Boston Children's Hospital report positive results with risplidam, a small-molecule drug that treats SMA by correcting the root cause: a mutated gene. Infants receiving risplidam showed improvements in motor function and lived longer than expected.
A recent study examines the one-year experience of cancer clinical trial enrollment after the COVID-19 outbreak in the US. Researchers found that participation rates declined significantly during this period.
The National Institute on Aging (NIA) has launched Outreach Pro, a new online tool to help increase awareness and participation in Alzheimer's clinical trials among traditionally underrepresented communities. The tool allows researchers to create customizable recruiting materials with an emphasis on reaching diverse populations.
The study aims to compare two interventions: Intensive Tailored Telehealth Management (ITTM) and Intensive Clinic Management (ICM). Researchers hope to answer how to effectively manage blood pressure among stroke survivors and whether telehealth is the most effective strategy.
Researchers found that targeted behavioral science messages significantly increased COVID-19 vaccination registration among healthcare workers. The study showed a substantial increase in vaccine uptake after receiving personalized email nudges.
Patients who underwent bariatric surgery reported improved physical health, energy, and reduced body pain compared to those on medical therapy alone. Significant weight loss and insulin independence drove these improvements in general health measures and quality of life.
A study found that antibodies produced to fight Covid-19 can trigger platelet activity, leading to fatal blood clots. Researchers developed a lab-based test to replicate this process, and suggest that existing medications may be able to inhibit platelet response.
A phase 2 trial of Loncastuximab tesirine demonstrates efficacy in treating relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL), with a response rate of 48% among patients. The drug, an antibody-drug complex targeting CD19, provides a novel mechanism of action for this patient population.
A randomized clinical trial found that semi-annual application of 5% sodium fluoride varnish significantly reduces approximal caries development in primary teeth compared to 38% silver diamine fluoride and placebo controls. The study evaluated 4-6 year-old children with at least one sound approximal surface.
A novel method predicts COVID-19 clinical trial success rates by analyzing features from clinical trial reports, including keywords and drug information. The model achieved high accuracy in predicting trial status, indicating a potential tool for optimizing research efforts and reducing costs.
A clinical trial found pimavanserin significantly improves sustained symptom benefit and reduces relapse rate in people with dementia-related psychosis. The treatment also showed fewer serious side effects compared to other antipsychotics.
The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with the International Vaccine Institute (IVI) to conduct clinical trials of Sinopharm's BBIBP-CorV vaccine in African populations. The ECOVA programme aims to generate data on vaccine efficacy and safety against variants of concern, enabling expanded access to va...
The global Phase 2/3 study with opaganib in patients hospitalized with severe COVID-19 pneumonia has completed patient treatment and follow-up. The company expects to report top-line results in the coming weeks, which will determine the efficacy of opaganib in treating COVID-19.
Zeynep Eroglu, MD, assistant member of the Cutaneous Oncology Department at Moffitt Cancer Center, received the 2021 Cancer Clinical Investigator Team Leadership Award from the National Cancer Institute. The award recognizes outstanding clinical investigators working to improve cancer care.
A randomized clinical trial found physician messaging campaigns increased COVID-19 knowledge, information-seeking, and self-reported protective behaviors among diverse groups. The campaign was effective in promoting adult's practices related to COVID-19.
A groundbreaking treatment using 3D printed implants has received approval to be trialled in UK patients, aiming to provide relief for knee osteoarthritis sufferers. The bespoke titanium alloy implants are designed to reduce discomfort and improve surgical accuracy, with the first trials expected to begin once clinical centres reopen.