Articles tagged with Clinical Trials
A phase 2 study found that simvastatin slowed brain atrophy by 43% over two years compared to placebo. The medication was well-tolerated and showed small but significant improvements in disability scales.
Heart failure is commonly assessed as a complication of diabetes but rarely considered as an outcome in glucose-lowering drug trials. Recent studies suggest some drugs may increase cardiovascular risk despite lowering blood glucose, prompting new regulations for cardiovascular outcomes trials.
A review of 64 randomized controlled trials found no consistent evidence that home care visits improve the lives of elderly individuals. The studies, conducted over the last 20 years, involved nearly 29,000 people aged over 65 and examined various outcomes such as mortality rates, falls, hospitalization, and quality of life.
Approximately 25 percent of randomized clinical trials were discontinued between 2000 and 2003, mainly due to poor recruitment, with only 38 percent reported to research ethics committees. Discontinued trials were less likely to be published, especially those sponsored by industry.
A study found nearly all clinical trials had at least one discrepancy in the study group, intervention, or results reported on ClinicalTrials.gov versus high-impact journals. Discrepancies included primary end points, dosages, and frequencies of interventions.
A Yale University analysis found nearly all clinical trials had discrepancies between reported results and published articles. The study suggests errors in reporting or intentional changes may have occurred. Accurate reporting is crucial for maintaining trial integrity.
A Phase 1 clinical trial of mecasermin (rh-IGF-1) in girls with Rett syndrome demonstrated the treatment's safety and efficacy in ameliorating certain symptoms. The study suggests that IGF-1 could be a potential treatment for Rett Syndrome, paving the way for further research and possible FDA approval.
A pilot study from Stanford Medicine found no significant difference in digestive issues between consuming raw milk and pasteurized milk among lactose-intolerant participants. The study tested 16 participants with the highest levels of lactose intolerance, but results showed no improvement in symptoms when switching to raw milk.
A new approach to prostate cancer screening is needed, focusing on high-risk men rather than the entire population. The risk-based approach uses a computer-generated calculator that assesses factors like PSA levels, family history, and ethnicity to identify those at greatest risk.
Dr. Daniel D. Von Hoff, a leading physician and scientist, has made significant advancements in cancer treatment with the development of multiple anticancer agents, including gemcitabine and nab-paclitaxel. His work has improved patient care and survival rates for patients with stage IV pancreatic cancer.
A recent study analyzed nearly 24,000 active human research clinical trials and found that 5-16% are not covered by two major federal regulations. The primary federal human subjects protections policies in the US include FDA HSP regulations and the Common Rule, which can lead to overlap trials and gap trials with varying characteristics.
A study of high-achieving young physician-researchers reveals pronounced gender differences in domestic activities among those married with children. Additionally, single-patient trials may help determine statin tolerability, while a US survey reports 2.7 million living with chronic Hep C virus.
A new study published in JNCI Journal of the National Cancer Institute found that high-dose selenium supplementation increased the risk of high-grade prostate cancer among older men with high baseline toenail selenium concentrations. Vitamin E supplementation also raised PC risk, especially among men with low baseline selenium levels.
A clinical trial found that adding bevacizumab to standard glioblastoma treatment did not increase overall survival, but did delay the risk of toxicity. The study also showed a decline in neurocognitive function and quality of life for patients receiving bevacizumab.
The REACT clinical trial found that an accelerated step-care approach can improve the management of Crohn's disease by inducing remission, reducing corticosteroid use, and healing intestinal ulcers. This new strategy involves early introduction of combined immunosuppression in high-risk patients.
A new Phase III clinical trial at Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute aims to provide kidney cancer patients with long-term control of their disease. The vaccine-based approach uses a patient's own immune system to fight the disease, potentially improving survival outcomes and quality of life.
The cumulative success rate for new agents in advanced NSCLC is lower than industry estimates, but biomarker- and receptor-targeted therapies substantially increase success rates. Biomarker-targeted therapy shows a 62% cumulative success rate, nearly six times higher than non-biomarker targeted trials.
A €3.5m European Union-funded project aims to improve diagnosis and treatment of balance disorders through an online information system. The EMBalance tool will help clinicians accurately diagnose and manage balance-related conditions, reducing the risk of falls and improving patient independence.
A thin transparent silicone dressing applied from day one can prevent severe skin reactions during radiation therapy, according to New Zealand research. The dressings create a protective environment for skin stem cells to heal from radiation damage.
A Canadian study of 89,000 women aged 40-59 found that annual breast screening did not reduce mortality from breast cancer beyond physical examination or usual care. The study also revealed that 22% of screen-detected cancers were over-diagnosed, with one over-diagnosed cancer for every 424 women screened.
A phase II clinical trial found creatine safe and well-tolerated by most participants, with neuroimaging showing a treatment-associated slowing of regional brain atrophy. The study also enrolled participants without knowing their genetic status, allowing them to participate while respecting their autonomy.
Recent publication in the European Heart Journal questioned the use of beta blockers in perioperative care, sparking debate. A new editorial addresses these concerns, highlighting the importance of dosing and starting time of betablockade before surgery on outcome.
A new study shows that administering a drug to pregnant mice with models of autism prevents autistic behavior in their offspring. The researchers believe that abnormal chloride levels may cause the defective GABA switch associated with autism, and that these levels may be treatable beyond infancy.
A large-scale study of whole-genome testing has identified a unique treatment approach for women with advanced breast cancer, targeting genomic alterations in their tumors. The study found that around half of patients had targetable genomic alterations, and 39% had rare alterations, many of which no treatments currently exist.
Researchers have developed a vaccine that triggers an immune cell response within the damaged tissue itself, potentially providing a more accurate way to evaluate its effectiveness. The vaccine has shown promise in treating cervical precancers, with some patients experiencing complete regression of lesions.
A recent EORTC study found that health-related quality of life (HRQOL) assessments provide relevant information in small-cell lung cancer trials, even when treatment efficacy is similar. The study highlights the need for improved HRQOL reporting in randomized clinical trials to optimize their value.
Scientists are conducting a Phase 1 clinical trial of EDP-788, an oral antibiotic targeting methicillin-resistant Staphylococcus aureus (MRSA) infections. The trial will evaluate the safety and pharmacokinetics of the drug in healthy participants.
A new analysis of 40 randomized controlled trials suggests that vitamin D supplementation does not prevent heart attacks, strokes, or bone fractures. The study concludes that vitamin D supplements probably provide little to no health benefit, contradicting previous observational studies that linked deficiency to poor health.
The FDA's premarket approval process for cardiac implantable devices allows for incremental innovation with minimal data collection. The study found that 37% of supplements represented minor alterations to device design or materials, and only 23% included new clinical data.
A study found wide variation in the quality of evidence used by the FDA to approve new drugs, including differences in trial size, design, and duration. This variability highlights the agency's flexible standards for approval, allowing for rapid approval of potentially effective therapies.
A multicenter study found that a Mediterranean diet supplemented with extra-virgin olive oil or nuts significantly reduced the risk of peripheral artery disease. The study, published in JAMA, included over 7,400 participants and followed them for nearly five years.
A phase II clinical trial of Avastin (Bevacizumab) with cisplatin and pelvic radiation for locally advanced cervical cancer showed promising results. The study found improved overall survival rates of 89.8% at 2 years and 80.2% at 3 years compared to historical controls.
A Phase 2 trial found that inosine treatment successfully raised participants' urate levels without serious side effects. The study suggests that urate elevation may slow Parkinson disease progression and supports further investigation into its potential as a disease-modifying strategy.
Researchers at UBC-VCH have developed a potential cure for aniridia, a rare eye disease affecting 5,000 people in North America. They formulated the drug Ataluren into eye drops and found it restored normal vision in mice with the condition.
The Icahn School of Medicine at Mount Sinai is part of a new NIH Stroke Research Network aiming to expedite stroke clinical trials and build expertise in stroke prevention, treatment, and rehabilitation. The school will receive a $1.3 million grant to develop a collaborative research infrastructure.
Research at Albert Einstein College of Medicine found that lactation consultants improved breastfeeding rates among women who resisted it. The studies showed that support from a lactation consultant significantly increased the chances of exclusive breastfeeding for three months, crucial for mother and child health benefits.
The EORTC-GIMEMA AML-12 Trial found that high-dose cytarabine improved outcomes for adult patients with acute myeloid leukemia, especially those younger than 46 years. High-dose treatment resulted in higher remission and survival rates compared to standard-dose treatment.
A phase III clinical trial found that adding ramucirumab to chemotherapy drug docetaxel did not delay disease progression for patients with HER2-negative, advanced breast cancer. Researchers will analyze biomarkers to identify potential subgroups of patients who may benefit from the therapy.
The University of Texas Health Science Center at Houston has been named a regional stroke center by the National Institutes of Health, with a focus on prevention, treatment, and recovery. Researchers are testing new treatments, including stem cell therapies, to improve stroke care.
A phase III clinical trial found that switching to a different chemotherapy did not improve overall survival or time to progression for women with metastatic breast cancer and elevated circulating tumor cells. Patients with low CTCs before starting chemotherapy had a median overall survival of 35 months, while those with elevated CTCs ...
The NIH Stroke Trials Network, or NIH StrokeNet, aims to address the three prongs of stroke research: prevention, treatment, and recovery. The network will fund and manage 25 regional centers, each with a team representing every medical specialty needed for stroke care.
A team of researchers will conduct a four-year trial comparing traditional bypass surgery with endovascular treatment for patients with critical limb ischemia. The trial aims to provide guidance on cost-effective ways to treat this devastating disorder, which affects millions of Americans.
A recent study found that over 18% of lung cancers detected by low-dose computed tomography (LDCT) may be cases of overdiagnosis, where the cancer would not have become clinically apparent without screening. This could lead to unnecessary treatment, anxiety, and increased healthcare costs.
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.