Articles tagged with Clinical Trials
A new study reveals that rural Americans face significant challenges in accessing COVID-19 treatment trials, with many living more than an hour away from the nearest trial site. Native Americans and Alaska Natives are particularly affected, with over 50% living more than 60 minutes from a trial site.
A Phase III clinical trial found no significant increase in genitourinary or gastrointestinal toxicity with hypofractionated post-operative prostate bed radiotherapy compared to conventional radiotherapy. However, dose-escalated radiation therapy was not shown to be superior to conventional RT.
A recent clinical trial found that a shortened course of radiation therapy after prostate removal surgery does not increase long-term side effects or lower quality of life compared to conventional treatment. Patients who underwent hypofractionated, post-operative radiation therapy experienced comparable genitourinary and gastrointestin...
Researchers at UVA Health System found that fluoxetine, an antidepressant commonly known as Prozac, shows promise against age-related macular degeneration. Patients taking fluoxetine were less likely to develop dry AMD, a condition affecting nearly 200 million people worldwide.
Researchers at Massachusetts General Hospital have found that immune checkpoint inhibitors can generate promising results in patients with leptomeningeal carcinomatosis (LMD), a rare complication of cancer. The treatment showed increased activity in cancer-killing immune cells and expression of particular genes within cells.
ImCheck's ICT01 selectively activates Vγ9Vδ2 T cells through all three isoforms of BTN3A, overcoming prior limitations. The therapy demonstrates anti-tumor activity in solid and hematologic cancer models.
Researchers found that adding interferon to bone marrow transplant significantly reduced leukemia relapse among high-risk patients, improving outcomes. The study suggests a potential new strategy for treating advanced acute myeloid leukemia, with further research needed to confirm the findings.
A randomized clinical trial found that combined varenicline and nicotine patch therapy did not improve 7-day abstinence rates compared to varenicline treatment alone or extended vs. reduced treatment duration
A clinical trial found that interferon beta-1a plus remdesivir was not superior to remdesivir alone in improving health outcomes for hospitalized adults with COVID-19. Interferon beta-1a was associated with more adverse events and worse outcomes in patients requiring high-flow oxygen.
Researchers report that 90% of patients who received gene therapy between 2009 and 2012 remain disease-free, with significant immune system differences observed among those treated. The therapy is most effective in younger children, but further work is needed to achieve high levels of gene correction in all patients.
A University of Illinois Chicago clinical trial aims to evaluate the impact of a healthy diet on asthma management in adults. Participants with uncontrolled asthma will be assigned to either an education-only group or a group receiving dietary counseling and guidance on the DASH eating plan, a diet approach proven for hypertension mana...
A recent study published by the American Academy of Neurology found that women are underrepresented in stroke clinical trials, with a participation-to-prevalence ratio of 0.84. This disparity may limit the applicability of trial results to the general population and affect access to new therapies.
A clinical trial found that a green Mediterranean diet rich in leafy greens like Mankai and green tea can elevate fasting ghrelin levels, reducing belly fat and improving insulin sensitivity. This approach may also have additional cardiometabolic benefits.
A comprehensive review of formula milk trials found that only 17% were conducted independently of formula companies, and most had a high risk of bias due to selective reporting. The researchers call for substantial changes in the conduct and reporting of formula trials to protect participants from harm.
Researchers at Sunnybrook Health Sciences Centre have successfully delivered antibody therapy to breast cancer metastases in the brain using focused ultrasound. The treatment, which temporarily opens the blood-brain barrier, has shown promising results with tumor size reductions of up to 21% in patients.
A new trial has found that vaginal laser therapy treatments claim to reduce negative vaginal symptoms of menopause – experienced by about half of all women – by up to 100 per cent. However, the study shows they might not work at all, with no difference found between the laser treatment and a placebo.
A randomized controlled trial of 1,600 patients found that rates of survival, functional recovery, and post-operative delirium are similar for both general and spinal anesthesia. This challenges common thinking about spinal anesthesia being safer.
A new smartphone-based app, iBehavior, will be tested to improve the accuracy of data in clinical trials involving individuals with intellectual disability. The app uses ecological momentary assessment to track symptoms related to executive function, often associated with ADHD.
A study found that pediatric clinical trials in the US were underrepresented by Black children, Hispanic/Latino children, American Indian/Alaska Native, Asian, and Native Pacific Islander children. Researchers are calling for improvements to enrollment processes to increase diversity and generalizability of trial results.
Researchers developed a novel machine learning algorithm to identify previously unknown air pollutant mixtures linked to poor asthma outcomes in children. The study found that early exposure to individual and mixed pollutants can lead to longer-term problems with asthma, affecting about seven percent of US children.
A study published by the American College of Cardiology found a significant inverse relationship between oral health and COVID-19 severity, as well as delayed recovery and increased inflammation in patients with cardiovascular diseases. Researchers recommend maintaining good oral hygiene to prevent or decrease COVID-19 disease severity.
A phase II clinical trial has shown that the DNA alkylation drug DM-CHOC-PEN improved survival in adolescent and young adult patients with central nervous system cancers. The treatment was well-tolerated, with no severe toxicities observed, and showed potential for combination with other treatments.
The National Kidney Foundation has released a research roadmap to accelerate innovations in treatment and increase understanding of kidney disease. The report calls for increased funding in preclinical science, genetics, health equity, and implementation science to tackle the most vexing challenges in kidney disease.
A simulated screening process for a pancreatic cancer clinical trial showed that Black patients were significantly more likely than white patients to be excluded from trials. The study found that nutrition and infectious disease criteria disproportionately excluded Black patients, while a history of prior cancer treatment excluded more...
Researchers at CNIO and 12 de Octubre Hospital have developed a new cancer treatment called CAR-NK-cell immunotherapy, which uses natural killer cells to target cancerous cells. The treatment has shown promising results in mice with multiple myeloma, with 25% of treated mice remaining disease-free.
The ARAMIS phase III clinical trial found that darolutamide improved metastasis-free survival and overall survival in Black/African American patients. Darolutamide-treated patients had a higher three-year overall survival rate and longer time to disease progression compared to placebo-treated patients.
A study found that chronic stress, measured by allostatic load, was associated with a lower likelihood of completing chemotherapy and lower overall survival rate in patients with lymph node-positive or high-risk lymph node-negative HER2-negative breast cancer. Allostatic load may be a better predictor than genetic ancestry for chemothe...
A clinical trial found that obese prostate cancer patients who underwent regular exercise training for 12 weeks had increased levels of anti-cancer myokines, which suppressed tumour growth and helped fight cancerous cells. The study suggests exercise may be a key weapon in cancer patients' battle against the disease.
A clinical trial found that convalescent plasma did not improve survival rates in most critically ill COVID-19 patients. However, immunocompromised patients showed a slight improvement with the treatment. The researchers speculate that too few high-quality antibodies and a runaway inflammatory immune response may be to blame.
Researchers have discovered toxic DNA buildup in the eyes of patients with geographic atrophy, a devastating form of age-related macular degeneration. Common HIV drugs or safer alternatives, such as Kamuvudines, may block inflammation and protect against retinal cell death, offering new hope for treatment.
A new ex vivo drug delivery system has been shown to keep MSCs viable longer and reprogram the peripheral immune response toward organ repair. The study's results suggest that SBI-101 can impact a peripheral immune response that can be transmitted to local tissue damage in vital organs, including the kidney.
A clinical trial conducted by TTUHSC researchers found that corneal epithelial stem cell-derived eye drops significantly improved symptoms of severe dry eye disease, with patients experiencing a 23% improvement in SPEED questionnaire scores and a 17.1% improvement in OSDI scores. No adverse reactions were reported during the 12-week tr...
The SPIRIT-Path extension provides evidence-based guidance to standardize pathology content in clinical trial protocols, ensuring methodological rigor and adequate skills and resources. Pathology is integral to trial planning and delivery, and the new guidelines formalize pathology input into clinical trials.
Researchers have identified a way to restore the effectiveness of drugs in clinical trials for treating AML by using human alpha(1)-acid glycoprotein (AGP) as a 'decoy' to bind and inhibit FLT3-mutated leukemia cells. The approach has potential for improving patient outcomes, particularly for patients with FLT3-mutated AML.
New targeted therapies are being developed to target genetic alterations in cancer cells, such as the ARID1A mutation found in 10-50% of solid tumours. Early clinical trials suggest that these agents may be effective in treating multiple cancers, including breast, ovarian, and gastric cancer.
A recent study published in JNCCN found that four out of five cancer therapies tested in Phase III trials did not achieve clinically-meaningful benefits in prolonging survival. The researchers analyzed 362 industry-sponsored trials and found that 87% were either false-positive or true-negative for meeting overall survival goals.
A nationwide team of researchers will investigate epigenetic therapies for cancer, with a focus on exploring new targets and investigating novel combinations. The project aims to improve current epigenetic therapies and enhance existing approaches such as immunotherapy.
The IMpower010 trial demonstrates that atezolizumab significantly improves disease-free survival in resected, early-stage NSCLC patients compared to best supportive care. Tumors expressing PD-L1 > 50% show a greater benefit of treatment.
The FIRSTMAPPP trial found that sunitinib significantly prolongs progression-free survival in patients with malignant pheochromocytoma and paraganglioma. The study demonstrated the efficacy of sunitinib as a treatment option for this rare cancer, which is commonly treated with old and toxic agents.
A parent-led therapy for early signs of autism has significantly reduced the likelihood of an autism diagnosis at age three. The iBASIS-VIPP program uses video-feedback to support social development and unique abilities, resulting in increased parental sensitivity and language development.
The NCI-funded National Clinical Trials Network has added 14 million years of life to people diagnosed with cancer in the US. The network's randomized phase III studies have had a profound impact on cancer research and treatment, influencing over 80% of treatment guideline recommendations.
Researchers discovered that financial incentives effectively increased enrollment in a randomized clinical trial, while also minimizing potential negative effects. The study suggests that incentives can be used to promote research participation, making it an attractive option for future studies.
The MONALEESA-2 trial found that adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The combination of endocrine therapy and the CDK 4/6 inhibitor ribociclib also extends progression-free survival.
Two phase III trials by VHIO researchers reveal significant clinical activity of trastuzumab deruxtecan in HER2-positive metastatic breast cancer, with over half of patients experiencing two years without disease progression. Trastuzumab duocarmazine also shows promise in treating HER2-negative breast cancer and other tumor types.
A Phase III trial showed a significant overall survival benefit of 63.9 months with ribociclib, compared to 51.4 months with hormone therapy alone. The estimated six-year survival rate was 44.2% with ribociclib, compared to 32% for placebo.
Novartis presents Phase III MONALEESA-2 study results demonstrating improved overall survival with Kisqali (ribociclib) in combination with letrozole. The analysis shows a statistically significant and clinically meaningful improvement in survival, with median OS of 63.9 months.
A novel combination of abiraterone acetate and prednisolone has been shown to prolong survival in patients with hormone/castration-sensitive prostate cancer. Studies PEACE-1 and STAMPEDE found that the addition of these drugs to standard therapy lengthened survival compared to standard therapy alone.
The KEYNOTE-716 trial shows that adjuvant pembrolizumab significantly prolongs recurrence-free survival and halves distant recurrences in stage II B/C melanoma patients. This suggests that patients with high-risk stage II melanoma should be offered adjuvant therapy.
A clinical trial found that over half of patients with non-small cell lung cancer (NSCLC) with a HER2 gene mutation had their tumors stop growing or shrink after treatment with trastuzumab deruxtecan. The drug showed durable responses in 54.9% of patients, with median survival period of 17.8 months.
A new study has shown that a single dose of typhoid conjugate vaccine (TCV) is safe and 84 percent effective in protecting against typhoid in Blantyre, Malawi. The findings are critical as typhoid is an increasing public health threat across sub-Saharan Africa.
Researchers found that patients with low sTK1 levels live longer and have slower disease progression after anti-estrogen treatment. Patients with high sTK1 levels tend to have shorter progression-free survival times and die sooner.
A new study suggests that age does not negatively impact on survival benefit from immune checkpoint inhibitors in elderly patients with stage IV NSCLC. Patients aged 75 and older showed a significant survival benefit from ICIs compared to younger patients.
A two-dose Ebola vaccine regimen has been found to be safe, well-tolerated, and produce a strong immune response in people over 1 year old. The study also supports the use of this regimen for Ebola virus disease prevention in children and adults.
The UK Lung Screening Trial (UKLS) found a significant reduction in lung cancer mortality among high-risk groups through low-dose CT screening. The study, which included over 4,000 participants, showed a 16% relative reduction in lung cancer deaths.
A phase II trial found that high-dose cytarabine followed by pembrolizumab improved cancer remission rates in AML patients, with a complete remission rate of 38%. The treatment also showed promise for patients who had not benefited from standard therapy.
A randomized clinical trial found that students who received eye exams and glasses through a school-based vision program showed improved reading scores and academic achievement over one year. However, these positive effects were not sustained at two years after the program ended.
Researchers found that ribociclib achieved pharmacologically-relevant concentrations in tumor tissue, while everolimus showed minimal penetration. The combination is promising for brain cancer treatment and could lead to new therapeutic drug combinations.
A new antioxidant drug, cysteamine, has been found to reverse atherosclerosis by reducing the oxidation of LDL cholesterol. This process reduces inflammation, damage, and clot formation, ultimately lowering the risk of heart attacks and strokes. Cysteamine was shown to decrease plaque size by up to 56% in mice with atherosclerosis.
Dr. Michael Boyer is the chief clinical officer at The Lighthouse Chris O'Brien comprehensive cancer center in Sydney, Australia. He has been recognized with the Adi F. Gazdar IASLC Merit Award for his pioneering work in molecular pathology and dedication to lung cancer research.
Patients treated by mobile stroke units had faster anti-clot medication delivery and less disability at 90 days compared to standard ambulance care, according to a study published in NEJM. The trial, which enrolled over 1,500 patients, showed that MSU-treated patients were more likely to receive tPA and have better mortality rates.