Articles tagged with Clinical Trials
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The REiNS Collaboration has established a framework for standardized outcome measures in neurofibromatosis clinical trials. The new guidelines address patient-reported outcomes, functional outcomes affecting vision, hearing and facial function, imaging tumor response, and disease biomarkers.
A large systematic review found no link between vitamin D supplementation and reduced risk of acute and chronic diseases, casting doubt on its benefits. Decreases in vitamin D levels are likely a marker of deteriorating health rather than a cause of disease.
The EORTC-ESTRO joint session will present the latest research on soft tissue sarcoma treatment, emphasizing the importance of early patient management. Key experts will discuss optimal timing sequences for radiotherapy in limb and retroperitoneal sarcomas, as well as current concepts in chordoma management.
A new clinical study shows that a tongue-controlled wheelchair can access computers and execute commands faster than sip-and-puff systems, with equal accuracy. The Tongue Drive System enables people with tetraplegia to maneuver their wheelchairs better than those using traditional assistive technologies.
A study published in JAMA found that induced hypothermia does not improve outcomes for patients with severe bacterial meningitis. In fact, it may even be harmful. The trial stopped early due to concerns over excess mortality in the hypothermia group.
Research finds that treating arteriovenous malformations (AVMs) in the brain can increase risks of stroke and death, while managing symptoms may be safer. The study suggests observing patients with AVMs for at least five more years to confirm this finding.
A new stroke research network is forming in Chicago, bringing together top medical centers to develop and execute high-quality clinical trials for stroke prevention, treatment, and recovery. The consortium aims to rapidly advance therapies and reduce death and disability from the disease.
A recent EORTC trial found that assessing HRQOL (health-related quality of life) is crucial for both patients with head and neck cancers and their doctors. The study showed that patients in the sequential treatment arm experienced less swallowing and speech problems compared to those in the alternating chemoradiotherapy arm.
A new study published at AHA Scientific Sessions 2013 found that a single dose of stem cell therapy during surgery may improve heart function in LVAD patients. Researchers discovered that 50% of patients who received the treatment could tolerate temporarily turning down their device, compared to 20% of placebo patients.
A multicenter clinical trial found similar patient outcomes one year after surgery for both mitral valve repair and replacement. However, mitral valve replacement was shown to be more durable than repair in preventing recurrence of mitral regurgitation.
Researchers compared two surgical approaches for severe heart valve disease, including repair and replacement of the affected valve. The study found that after one year, there were similar outcomes between the two treatments, with some notable exceptions.
A study of 60 people aged 45 years or older found that accelerated surgery within six hours reduced major complications by 30% compared to standard care. Faster surgery may be better for hip fractures, say researchers at McMaster University.
A late-breaking clinical trial shows spironolactone reduces risk of repeated heart failure hospitalizations, but not overall mortality or cardiac arrest. The study enrolled 3,445 participants and followed them for nearly 3.5 years.
A randomized controlled trial found that early surgery for hip fractures in older adults can significantly reduce complications and improve outcomes. The study involved 60 patients aged 45 or older who received either accelerated care or standard care, with the former resulting in shorter wait times and improved surgical results.
Family members of patients with coronary heart disease improved cholesterol levels, physical activity, and dietary habits after participating in a year-long intervention program. The program included counselling sessions, goal setting, and feedback, resulting in reduced body mass index and waist circumference.
A new phase III trial has shown that trastuzumab and anthracyclines can be given sequentially to achieve high pathological complete response rates in HER-2 positive breast cancer patients. The treatment regimens had similar cardiac safety profiles, with no significant difference between concurrent and sequential administration.
Researchers at Michigan Medicine are conducting a clinical trial to determine the effectiveness of platelet-rich plasma (PRP) therapy on tennis elbow. The study compares PRP injections to other treatments, including physical therapy and dry needling, in a blind study to minimize bias.
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.