Articles tagged with Clinical Trials
The NIH-funded Antibacterial Resistance Leadership Group has reviewed over 70 study proposals and initiated more than 30 clinical studies to address antibacterial resistance. The group's key accomplishments include the launch of the CRACKLE study, a prospective multicenter cohort study designed to characterize CRE infections.
The European Society of Cardiology calls for rewritten clinical trial rules to protect patients and ensure reliable results. The current ICH Good Clinical Practice guidelines need to be based on principles rather than operational details.
A study published in the Journal of Clinical Oncology finds that childhood cancer deaths within a month of diagnosis are significantly higher than previously reported, affecting young children and minority groups disproportionately. The study used a large national database to find that early deaths from some pediatric cancer subtypes w...
A placebo-controlled trial shows that both audiology best practices and OTC models improve outcomes for older adults with mild-to-moderate hearing loss. The study's findings have implications for better hearing healthcare for millions of Americans.
A Phase III clinical trial revealed that blinatumomab significantly increased overall survival and remission rates compared to standard chemotherapy in patients with advanced acute lymphoblastic leukemia. The study showed a median survival of 7.7 months for those treated with blinatumomab versus four months for those on chemotherapy.
Researchers at UNC Lineberger Comprehensive Cancer Center have launched clinical trials testing genetically engineered immune cells to fight cancer. The early-stage trials aim to improve treatment options for patients with relapsed or refractory Hodgkin or non-Hodgkin lymphoma.
A clinical trial has demonstrated that a monoclonal antibody, lanadelumab, significantly reduces HAE attacks without serious side effects. The study found strong efficacy in participants receiving high doses of the treatment.
A clinical trial of 100 patients with ALS found that an eight-week mindfulness-based meditation program improved quality of life and reduced anxiety and depression. The results remained stable over a 12-month follow-up, suggesting a potential tool for increasing well-being in ALS patients.
A Phase 1 clinical trial is underway to test the safety and tolerability of an RSV vaccine in healthy adults. The study aims to assess the vaccine's ability to prompt an immune response and reduce the burden of this important disease.
The ASTER Trial shows no significant difference in revascularization rate and safety between Penumbra's aspiration system and stent retrievers for acute ischemic stroke patients with large vessel occlusions. The study provides evidence supporting the use of aspiration as a frontline thrombectomy approach.
A study published in JAMA and JAMA Internal Medicine found that testosterone treatment improved bone density and anemia, but not cognitive function, in older men with low testosterone. However, it also increased plaque buildup in coronary arteries, raising concerns about cardiac risk.
In less than a year, researchers have developed multiple vaccine platforms providing robust protection against Zika virus challenge in animal models. However, safety considerations and unique challenges associated with the virus must be addressed in clinical development.
Researchers developed a novel strategic framework to improve retention of minority, low-income children in randomized controlled trials. The framework was highly effective, with an attrition rate of only 11%, significantly lower than previous studies.
A new study published in JAMA suggests that testosterone treatments may increase the risk of heart disease in older men. The study found a significant increase in arterial plaque among men aged 65 and older who received testosterone replacement therapy for a year, with a 20% rise in total coronary and noncalcified plaque volumes.
The NIH is conducting a Phase 1 clinical trial to test an investigational vaccine called AGS-v, designed to trigger an immune response to mosquito saliva. The goal is to provide broad protection against mosquito-transmitted diseases such as Zika, malaria, and dengue fever.
A new study published in JAMA and J AMA Internal Medicine found that testosterone therapy improved bone density and strength, as well as reduced anemia in older men with low testosterone levels. However, the therapy had no impact on cognitive function and may worsen plaque in coronary arteries.
Constantine Gatsonis, a leading researcher on cancer screening studies, emphasizes the importance of rigorously produced evidence in health screenings. His work has shed light on the accuracy, cost-effectiveness, and impact of various screening methods, including digital mammography and tomosynthesis.
A systematic review of existing literature suggests that antibiotics are an effective alternative to surgery for acute non-complicated appendicitis in children. No safety concerns were reported, but a recurrence rate of 14% was noted.
Researchers have used gene therapy to treat Fabry disease, a rare inherited enzyme deficiency that can damage major organs and shorten lifespan. The treatment involves transplanted altered stem cells with copies of the fully functional gene responsible for the missing enzyme.
A review of worldwide studies found that high-dose B-vitamins significantly reduce schizophrenia symptoms. The research suggests that B vitamins are most beneficial when implemented early on and used with higher dosages or combined several vitamins.
A phase III trial of a fasting-like diet shows significant benefits for 'at-risk' patients, reducing cardiovascular risk factors, inflammation, and fasting glucose levels. The regimen also shrunk waistlines and resulted in weight loss, with sustained effects even after returning to normal daily eating habits.
A new online tool uses data from the PROMISE trial to predict patients at minimal risk for heart trouble, allowing primary care doctors to safely defer non-invasive cardiac tests. The tool considers 10 clinical variables and can help clinicians quantify minimal risk, opening a conversation with patients on whether a test is worthwhile.
Clinical trials are now enrolling at the University of Virginia Health System to test an artificial pancreas that automatically regulates blood-sugar levels in people with type 1 diabetes. The trials will examine safety, effectiveness, and cost as well as physical and emotional health.
A new assay has been developed to detect genetic mutations in tumors, showing high sensitivity and specificity in detecting actionable genomic variants. The NCI-MATCH trial aims to evaluate tumor biopsy specimens from 6,000 patients using this technology.
Researchers compared informed consent quality in clinical trials of a hookworm vaccine conducted in Brazil and the US. Despite differences in education and healthcare access, there were few statistically significant differences in consent quality between participants in urban and rural locations.
Researchers at Buck Institute for Research on Aging found that alpha-lipoic acid prevented stone formation in a mouse model of cystinuria, a rare inherited disease. The supplement increased the solubility of cystine crystals, providing a new function for alpha-lipoic acid.
A systematic review of 14 randomized trials found that vitamin C significantly reduced the incidence of post-operative atrial fibrillation in high-risk patients. The review also showed that vitamin C decreased hospital stay length and intensive care unit stay, with intravenous administration having greater effects.
A recent clinical trial found that controlling critically ill children's blood sugar levels within a usual care range does not offer significant benefits. In contrast, lower targets increased the risk of hypoglycemia without providing extra advantages.
A study published in the journal Microbiome shows that fecal microbial transplants can improve gastrointestinal symptoms associated with autism spectrum disorders by 80%, while also improving social skills and sleep habits by 20-25%. The treatment, which involves transferring live gut bacteria from a healthy donor to a recipient, has s...
A clinical trial found that Verapamil therapy improved symptoms in patients with CRS and nasal polyps, representing a promising novel therapy for the disease. The treatment's effectiveness was limited among patients with higher body mass indices.
A new study published in the Society for Maternal-Fetal Medicine's annual meeting found that a weight loss intervention did not improve pregnancy outcomes despite reducing maternal weight gain. The study, MOMFIT, tested an intensive lifestyle behavioral intervention to help overweight and obese women limit gestational weight gain.
A new trivalent vaccine induces antibodies against three different parts of the virus, including two components that help HSV2 evade immune attack. The vaccine provides strong immune response and potent neutralization of four isolates of HSV2 from sub-Saharan Africa.
A randomized clinical trial found that delayed umbilical cord clamping reduced anemia prevalence in infants at 8 and 12 months of age. The intervention, which involved waiting three or more minutes after birth, increased iron stores and improved hemoglobin levels.
The two organizations will collaborate on activities in strategic mutual interest, supporting intellectual exchange of expert consulting. Researchers at Baim Institute contributed to the landmark IMMEDIATE Trial, which significantly reduced composite endpoint of cardiac arrest or mortality.
A recent randomized trial compared active monitoring, surgery, and radiation therapy for localized prostate cancer. The study's results may be limited by differences in the active monitoring protocol and advances in treatment methods.
A $1.5m grant has been awarded by Edwards Lifesciences to investigate the impact of cardiac output-guided fluid therapy on patients undergoing major gut surgery, with 2,502 patients expected to participate in the trial.
A new study from the University of Eastern Finland found that vitamin D deficiency may increase the risk of chronic headache. Men with lower serum vitamin D levels reported more frequent headaches.
A review of dermatology clinical trials found that racial and ethnic groups are underrepresented among study participants, with most being white. The lack of diversity is attributed to inadequate reporting of ethnicity and race, which may lead to a more homogenous population. To address this issue, the review suggests prioritizing raci...
An experimental Ebola vaccine was highly protective against the deadly virus in a major trial in Guinea, showing no cases among those vaccinated within 10 days. The vaccine's efficacy also led to indirect protection through herd immunity in unvaccinated people, providing weight to early trial results.
A landmark trial found that shortened antibiotic courses for ear infections in young children (9-23 months) resulted in more treatment failures and adverse events without reducing antibiotic resistance. The study showed a significantly higher risk of recurrent infections when residual fluid was present after treatment.
A study published in mBio found that fecal microbiota transplantation was effective in treating recurrent C. difficile infection, with cure rates over 90%. The researchers identified specific microorganisms, such as Clostridium Xia clade and Holdemania, which are key for a successful transplant.
Researchers found that vitamin E and selenium supplements did not prevent colorectal adenomas in a large-scale study. The findings suggest that these antioxidants have no evidence of preventing cancer.
The bionic pancreas system successfully reduced average blood glucose levels and decreased the risk of hypoglycemia in patients with type 1 diabetes living at home. The system's automated monitoring and dose delivery significantly improved blood sugar control, reducing the risk of severe hypoglycemia and nocturnal episodes.
Researchers at UCR developed therapeutic monoclonal antibodies that selectively block the action of faulty matrix metalloproteinases (MMPs), targeting cancer cell spread. Inspired by camelid antibodies, these human antibodies have convex binding sites ideal for interactions with concave MMP sites.
A stem cell-based treatment, known as the Cell Bandage, has been trialled in humans and shown to repair damaged meniscus tissue, restoring full knee function. The trial received positive results, with three out of five patients retaining an intact meniscus after 24 months.
A University of Central Florida researcher has developed a nanoparticle technology that increases natural killer cells 10,000-fold, paving the way for accelerated clinical trials. The therapy shows promise in treating acute myeloid leukemia and could lead to the creation of on-site cancer treatments.
Recent developments in dendritic cell vaccines and oncolytic immunotherapy have led to improved outcomes in melanoma patients. Various vaccine candidates are being developed and tested in clinical trials, offering new avenues for treating this malignancy.
The NCI grant supports the Methods in Clinical Cancer Research Workshop, a one-week boot camp for new oncologists taught by Dr. Daniel Von Hoff and leading experts. The program helps train clinical researchers to improve cancer clinical trial design, increasing the number of effective interventions available to patients worldwide.
A comprehensive review of homeopathy in livestock found that many clinical trials have methodological limitations, making it difficult to draw conclusions about its effectiveness. The review suggests that more research is needed to fully understand the potential benefits and risks of using homeopathy in food-producing animals.
A group of 12 high-risk acute myeloid leukemia patients who received genetically engineered immune cells are still in remission after over two years. The treatment was successful in recognizing and destroying cancer cells, with no relapse observed in this cohort.
Patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who were initially ineligible for clinical trials due to existing medical conditions responded well to treatment with azacitidine (AZA) and vorinostat. Sixty-day survival rates were 83% and 79% respectively, with low-grade gastrointestinal side effects reported.
Researchers from Penn Medicine present early results from studies of CAR T cell therapy for multiple myeloma and relapsed/refractory acute lymphoblastic leukemia, showing high efficacy and safety profiles. The findings build on the team's work in CAR T cell therapies dating back to 2010.
A small study found that augmented reality and serious gaming therapy significantly reduced phantom limb pain, improving quality of life. The therapy involved training a virtual arm, racing, and copying movements, leading to halved pain intensity and frequency.
The JHU/Tufts MC/TUSM TIC will provide world-leading expertise in state-of-the-art trial design and execution of multi-site studies, particularly in neurology and cardiology. The center will lead innovative projects in clinical trial performance metrics and adaptive and integrated trial design to maximize trial performance.
The Hastings Center Report examines the ethics of crowdfunding for medical care, citing concerns over fraud, misinformation, and health inequities. The article proposes reducing the number of clinical trials to improve their quality and provide evidence-based decision-making.
A randomized clinical trial found that web-based cognitive behavior therapy for insomnia (CBT-I) improved sleep outcomes in adults. The fully automated and interactive SHUTi intervention was more effective than access to a patient education website alone, with participants showing significant improvements in sleep duration and quality.
Researchers at VIB and Ghent University have developed a diagnostic tool for Familial Mediterranean Fever, which can accurately diagnose the disease and prevent kidney failure. The tool detects changes in the body's immune reaction to pyrin, a protein mutated in FMF, and has been validated in 13 patients.
A randomized clinical trial led by Duke University School of Medicine researcher found that individual cognitive therapy relieved PTSD symptoms better and quicker than group therapy. Nearly half of participants who received one-on-one therapy improved so much they no longer carried a PTSD diagnosis, whereas almost 40 percent of those i...
A systematic review and meta-analysis found that palliative care was associated with improvements in patient quality of life, symptom burden, and advance care planning. The findings suggest that palliative care can have a positive impact on patients' lives, but more research is needed to identify the most effective interventions.
A new study found that palliative care significantly improves patients' quality of life and symptom burden, while also increasing patient and caregiver satisfaction. Researchers analyzed 43 trials involving 12,731 adults with serious illness and their family caregivers.