Articles tagged with Clinical Trials
The National Institute of Allergy and Infectious Diseases is sponsoring a Phase I clinical trial for an investigational genital herpes vaccine candidate, called HSV529. The trial aims to test the safety and immune response of the vaccine in adults aged 18-40 with previous HSV-2 or HSV-1 infections.
The EORTC trial found that perioperative chemotherapy with FOLFOX4 increases progression-free survival compared to surgery alone, but no significant difference in overall survival was observed. The study concludes that perioperative chemotherapy should remain the reference treatment for patients with resectable liver metastases from co...
Scientists have identified Lactobacillus brevis from a traditional Japanese pickle as having protective effects against influenza virus infection in mice. The bacteria's unique properties, including exopolysaccharides, are thought to enhance immune system function and eradicate virus-infected cells.
Researchers announced positive trial results for an artificial aortic heart valve that does not require open-heart surgery. The device showed high survival rates, low stroke risk, and significant improvements in patients' quality of life.
The center will integrate operations at four locations, including the UC San Diego Jacobs Medical Center and the Sanford Consortium for Regenerative Medicine. It aims to translate discoveries into therapies that can improve and save lives, with a focus on treating cancer, Lou Gehrig's disease, and spinal cord injury.
The TATORT-NSTEMI trial found that aspirating blood clots does not significantly reduce microvascular obstruction or the risk of death in patients with non-ST-elevation myocardial infarction (NSTEMI). Standard PCI without thrombectomy was shown to be equally effective.
The DUTCH PEERS (TWENTE II) trial found that two third-generation permanent polymer-based drug-eluting stents had low rates of adverse clinical events, establishing the non-inferiority of a zotarolimus-eluting stent. The study also showed no significant differences in individual components of the primary endpoint.
The REPRISE II trial demonstrated low rates of complications with the second-generation transcatheter aortic valve, including minimal post-procedure paravalvular aortic regurgitation. The device successfully addressed challenges associated with TAVR, improving outcomes for patients with severe aortic stenosis.
The SMART-CASE trial found that a conservative approach to revascularization for patients with intermediate coronary lesions is safe and comparable to an aggressive strategy. After one year, both groups had similar rates of adverse events and clinical outcomes.
The TRYTON trial compared a new bare metal bifurcation stent with standard practice and found it safe, but did not meet the non-inferiority endpoint. The strategy showed improved angiographic outcomes in larger side branches, but more frequent peri-procedural CK-MB elevations.
The RIBS V trial found that both drug-eluting balloons and stents provide excellent long-term clinical outcomes for patients with bare metal stent restenosis. Angiographic results showed superior late angiographic results for drug-eluting stents, but low rates of clinical and angiographic recurrences in both groups.
A new clinical trial found that a two-stent technique for treating bifurcation lesions with a large stenotic side branch is not associated with improved mid-term outcomes compared to a provisional stenting approach. The study, presented at TCT 2013, showed similar rates of major adverse cardiac events (MACE) between the two techniques.
The CHILL-MI trial found that therapeutic hypothermia using intravenous cold saline and endovascular venous cooling reduced clinical heart failure incidence by 71% in STEMI patients. However, the trial missed its primary endpoint of reducing infarct size.
The EUROMAX trial reveals that administering bivalirudin to STEMI patients in pre-hospital settings significantly reduces death and major bleeding complications compared to heparin. Bivalirudin also showed a lower rate of reinfarction and death, however with increased risk of acute stent thrombosis.
A new strategy for emergency anticoagulant treatment has been developed, using bivalirudin, which reduces the risk of death or serious bleeding by 8.5%, compared to traditional heparin treatment. The EUROMAX clinical trial found that this approach improves patient outcomes without increasing the risk of stent thrombosis.
A recent study found that almost 1 in 3 large clinical trials remain unpublished five years after completion, with 78% having no results publicly available. This phenomenon violates an ethical obligation towards study participants, highlighting the need for additional safeguards to ensure timely public dissemination of trial data.
Exercise programs designed for older adults appear to reduce the risk of injuries caused by falls, including fractures and other serious injuries. The review of 17 trials found that these programs can significantly decrease the rate of falls resulting in medical care, serious injuries, and fractures.
The SAFE-PCI for Women trial found that radial access reduced bleeding and complication rates compared to femoral access, with a significant benefit seen in the overall cohort. The study's findings suggest that radial access is a reasonable strategy for women undergoing cardiac catheterization.
The COREVALVE EXTREME RISK trial found that the self-expanding transcatheter aortic valve reduced all-cause mortality or major stroke rate by 68% at 12 months compared to the pre-specified performance goal. The study included 487 patients with severe aortic stenosis, most of whom were elderly and had high surgical risk.
The PROSPECT II trial will enroll 900 patients with acute coronary syndrome to assess the ability of intracoronary near infrared spectroscopy (NIRS) to identify non-flow obstructing vulnerable plaques. The study will also evaluate the feasibility of a bioresorbable scaffold in preventing future major adverse cardiovascular events.
Researchers at UAB designed an antibody fragment that cleared Aβ peptide oligomers from the cerebral cortex, reversing anxiety and learning memory deficits in mice. The treatment also improved apolipoprotein levels, suggesting a potential therapeutic approach for Alzheimer's disease.
A recent EORTC trial found that detecting ERG gene deletion at diagnosis of childhood B-cell precursor acute lymphoblastic leukemia (ALL) is beneficial for risk stratification. Patients with the ERG gene deletion had an 8-year event-free survival rate of 86.4% and overall survival of 95.6%.
Researchers at Penn Medicine found that focusing on factors like hope, randomization, and altruism can increase patient willingness to participate in clinical trials for malignant pleural mesothelioma. The study showed a significant increase in participation rates when physicians spent more time discussing these factors with patients.
The EORTC/GIMEMA 06012 trial found sequential combination of gemtuzumab ozogamicin (GO) and standard chemotherapy has no benefit for older patients with acute myeloid leukemia. GO is too toxic for patients over 70 years old, whereas younger patients may potentially benefit from such treatment.
A new report from Harvard University proposes recommendations for addressing the challenge of expanding public access to clinical trial data. The authors suggest a system that balances the need for transparency with the protection of research participants' identities, while also minimizing burdens on trial sponsors.
The article discusses new recommendations for overcoming issues related to cancer clinical trial accrual. Strategies include involving patient advocates and improving communication with patients, developing evidence-based training initiatives for providers, and promoting accrual through leadership best practices at the site level.
A Phase III trial found that low-level laser therapy (LLLT) significantly reduces the incidence of severe canker sores (grades 3 and 4) in head and neck squamous cell carcinoma patients undergoing concurrent chemoradiotherapy. LLLT also improves patient quality of life, reducing oral pain and opioid analgesic use.
The study found that nab-paclitaxel plus gemcitabine led to significantly improved overall survival and progression-free survival compared to gemcitabine alone. Participants who received nab-paclitaxel also experienced a delay in tumor growth and higher survival rates, with 35% surviving over 1 year.
The study found no clinically meaningful differences in overall quality of care between the LCP-I wards and control wards. However, families rated key aspects of care such as respect, dignity, and kindness, showing some improvement in the LCP-I wards.
The study found that the CVR is as effective as other combined hormonal contraceptives in preventing pregnancy and has a consistent safety profile. Women were highly satisfied with the ring and found it easy to use, making it an attractive option for women in developing countries.
The BrainGate team has developed a revolutionary brain-computer interface that allows people with severe paralysis to control robotic arms and interact with the world around them. The $1M B.R.A.I.N. Prize award recognizes their groundbreaking work in advancing technology for the betterment of humanity.
A three-way partnership between UCLA, USC, and UC Irvine will form the Los Angeles–Southern California Regional Coordinating Center to address stroke prevention, acute therapy, and recovery. The network will perform five to 10 clinical trials and educate fellows in stroke translational research.
Researchers at U-M Health System have begun a Phase II clinical trial using stem cells to treat amyotrophic lateral sclerosis (ALS), a debilitating disease affecting nerve cells. The trial, approved by the FDA and funded by Neuralstem Inc., aims to assess the safety and potential effects of injected stem cells on motor neurons.
A study published in PLOS Medicine found that unpublished clinical trial reports provide more complete information on patient-relevant outcomes than publicly available sources. The study's findings highlight the importance of making clinical trial data publicly available to support informed decision-making.
Researchers found that hypothermia treatment did not improve outcomes for adults with severe bacterial meningitis. In fact, the study suggests that moderate hypothermia may be harmful. The trial stopped early due to concerns over excess mortality in the hypothermia group.
A systematic review of 12 trials found that probiotics reduced crying in six out of the 12 trials. Probiotics were effective in treating colic in breastfed babies, but had limited effectiveness in formula-fed babies. Larger and more rigorous clinical trials are needed to confirm these findings.
The malaria vaccine candidate RTS,S has shown significant protection against clinical malaria and severe malaria cases in young children and infants. Over 18 months of follow-up, the vaccine reduced clinical malaria cases by almost half in children aged 5-17 months and malaria hospitalizations by 42%.
A comprehensive analysis of hormone therapy trials did not support its use for chronic disease prevention. The study found that menopausal hormone therapy may be suitable for managing symptoms in some women.
A new study by Yale University researchers found that older adults are more risk-averse than their midlife counterparts when choosing between possible gains, but more risk-seeking when choosing between losses. The study suggests important policy implications for decision-making across the lifespan.
The National Institute of Allergy and Infectious Diseases has awarded contracts to nine institutions, including Group Health Research Institute, to expand vaccine and treatment evaluation units. These centers will conduct clinical trials for promising candidate vaccines and therapies, aiming to protect the public from infectious diseases.
The NIH has awarded nine new contracts to strengthen the scope of its Vaccine and Treatment Evaluation Units, increasing funding from eight to nine institutions. The VTEUs will expand their ability to conduct research in domestic and international locations, including resource-poor settings.
Researchers have developed a new implantable device that reduces symptoms of central sleep apnea by 56% and improves sleepiness and quality of life. The device, which stimulates the diaphragm to breathe during sleep, has shown significant promise in treating this condition.
A clinical trial aims to determine the optimal timing of delivery for preterm pregnancies complicated by poor fetal growth. The study compares three groups and shows better-than-expected health outcomes for the babies, with low mortality rates and minimal severe health issues.
A new study by Moffitt Cancer Center aims to investigate alternative screening methods and chemoprevention interventions for African-American and black men with prostate cancer. Researchers are also exploring the safety and effectiveness of isoflavones, a botanical agent, in reducing prostate cancer risk in this high-risk population.
A new trial will test an anti-amyloid treatment in 650 adults at highest genetic risk for late-onset Alzheimer's, using the Alzheimer's Prevention Registry for enrollment. The study aims to prevent clinical onset of Alzheimer's and find effective treatments as soon as possible.
A European Organisation for Research and Treatment of Cancer trial found that adjuvant radiotherapy after local excision reduced the incidence of local recurrences by a factor of two, resulting in an overall lower risk of mastectomy. The study highlights the importance of conducting long-term follow-up.
The EORTC trial found that vaccination with GM2/KLH-QS-21 did not improve relapse-free or overall survival rates for patients with stage II melanoma. The vaccine was expected to stimulate antibodies against the GM2 ganglioside, but instead, it led to a higher risk of death and decreased survival rates.
The EORTC will present various cancer research studies, including a phase III trial on breast cancer radiation therapy and a study on the use of data warehouses for response measurements. The organization will also showcase its clinical trials and discuss regulatory issues.
A trial comparing e-cigarettes with nicotine patches found they were comparable in helping smokers quit, with e-cigarettes showing higher reduction in cigarette consumption after six months. The study suggests e-cigarettes have potential as effective smoking cessation aids despite regulatory uncertainty and inconsistency.
A recent trial found that e-cigarettes were comparable to nicotine patches in helping smokers quit for at least six months. The study also showed that e-cigarette users had reduced cigarette consumption by half after six months compared to those using patches or placebo devices.
A new biomarker strategy using troponin and copeptin has the potential to change clinical practice with high patient safety, according to the BIC-8 trial. The strategy significantly increased emergency room discharge rates among patients with suspected ACS.
The PRAMI trial found that preventive PCI resulted in a two-thirds reduction of primary outcome events compared to culprit-only PCI. This new evidence suggests considering revising current guidelines for patients with multivessel disease and ST elevation myocardial infarction.
The TASTE trial found that aspiration of the blood clot causing a heart attack does not improve survival rates compared to balloon dilation and stenting alone. The study enrolled over 7,200 patients with ST-elevation myocardial infarction (STEMI) from Sweden, Denmark, and Iceland.
Primary Ciliary Dyskinesia (PCD) is a rare genetic disorder affecting the respiratory and other systems, with limited data due to small patient populations. The BESTCILIA project aims to improve screening and treatment through clinical trials, standardized diagnostic testing, and patient registries.
A new study published in BMC Public Health reveals that volunteering is associated with improvements in mental health and increased life satisfaction. Volunteers reported lower levels of depression and enhanced well-being, although the exact mechanisms underlying these benefits are unclear.
The GEMINI studies found vedolizumab to be an effective treatment for patients with moderately to severely active Crohn's disease and ulcerative colitis. The study suggests that the drug may provide people living with these conditions an additional option for inducing and maintaining clinical remission.
A randomized clinical trial found a significant increase in cerebral vasospasm and EVD-related complications when CSF was drained continuously in patients with subarachnoid hemorrhage. The study, halted early due to high complication rates, suggests continuous drainage may not be the best method for intracranial pressure management.
A study found that heart failure patients with left bundle-branch block (LBBB) and longer QRS duration had lower risks of death, cardiovascular events, and readmission after pacemaker implantation. These findings suggest using QRS morphology and duration to identify patients who will benefit most from the procedure.
Eating a healthy diet has been found to lower the risk of chronic kidney disease (CKD) and mortality among patients with type 2 diabetes. Moderate alcohol intake also reduced the risk of CKD, while high sodium intake was not associated with increased risk.
Researchers have successfully combined two promising gene therapies to repair muscle damage caused by Duchenne muscular dystrophy and prevent future injury. The treatment, which uses a combination of micro-dystrophin and follistatin, showed significant increases in muscle strength and reduced muscle damage in aged mice.