Articles tagged with Clinical Trials
A new investigational antibiotic cream has demonstrated a high cure rate of 81% for cutaneous leishmaniasis, with only minor reactions reported. The treatment offers a safe and effective option for patients, potentially replacing toxic and painful treatments.
A clinical trial combining brain cooling and clot-busting drug therapy has received FDA approval to expand from 50 to 400 participants. Brain cooling has been shown to reduce neurological damage after stroke, with potential benefits in saving lives and preventing neurological damage after heart attack.
A new study from the University of Pennsylvania School of Medicine reveals high levels of approval among trauma patients, families, and communities to participate in clinical trials without express consent. The findings provide important clues for increasing studies aimed at improving care for time-sensitive injuries.
Researchers found that cognitive behaviour therapy (CBT) and graded exercise therapy (GET), when combined with specialist medical care, can lead to significant improvements in symptoms and disability for patients with chronic fatigue syndrome. After one year, 22% of participants met the criteria for recovery, compared to 8% who receive...
The European Medicines Agency's initiative to release all clinical trial information has sparked debate on the role of medical journals in publishing drug data. As more data becomes available, reports of trials sanctioned by pharmaceutical companies will no longer be considered definitive records.
A recent study published in PLOS Medicine found significant discrepancies between internal company documents and published trial reports in industry-sponsored clinical trials. The researchers highlighted the need for standardizing definitions of analysis types, making full trial protocols and data publicly available, and ensuring regul...
A systematic review of 24 randomized clinical trials found significant observer bias in nonblinded outcome assessment, favoring a more beneficial treatment effect. The study recommends using blinded assessors to remove this bias and suggests that conscientious nonblinded assessors may overcompensate for expected biases.
Researchers in Calgary have launched the world's first gene therapy clinical trial for Fabry disease, a rare inherited enzyme deficiency. The trial aims to transplant stem cells with a working copy of the GLA gene into patients, potentially curing the condition.
A clinical trial to evaluate cyclodextrin as a potential treatment for Niemann-Pick disease type C1 has begun at the NIH Clinical Center. The disease, caused by cholesterol accumulation in cells, leads to progressive impairment of motor and intellectual function.
A Phase I clinical trial of a tetravalent candidate dengue vaccine found it induced a balanced antibody response against all four dengue viruses in most recipients. The vaccine was safe, and its development is promising for preventing severe dengue disease.
Researchers at UCSF and the Australian Joint Registry expose loopholes in the 510(k) clearance process that allow untested high-risk medical devices to reach the market. The devices have failed at a dangerously high rate, requiring multiple surgeries and posing unknown risks to patients.
A multi-center Phase III clinical trial demonstrates that Abraxane plus gemcitabine extends survival of late-stage pancreatic cancer patients compared to standard treatment. The study showed a 59 percent increase in one-year median survival rates and a doubling of two-year survival to 9%.
A new study from the University of Pennsylvania School of Medicine found that gene therapy improves vision in patients with Leber congenital amaurosis, but also advances retinal cell degeneration. The research provides a more nuanced understanding of the disease and its treatment.
An ASH international clinical network collaboration improved APL survival rates by replicating a high cure rate of 85% in patients in Central and South America. The standard-of-care protocol, including oral ATRA and daunorubicin-based chemotherapy, showed promising results with low cumulative incidence of relapse.
A recent study published in the Journal of Bone and Joint Surgery found that obese patients with lumbar disc herniation tend to have poorer outcomes with both surgical and nonsurgical treatments. The study included 854 non-obese patients and 336 obese patients, and compared their outcomes over a four-year period.
A UK-wide clinical trial has identified a treatment approach that significantly reduces the risk of kidney failure in patients with membranous nephropathy. The study, published in The Lancet, recommends alternating monthly cycles of prednisolone and chlorambucil as the most effective treatment for this common type of kidney disease.
A recent study found that a third of trials with no statistically significant benefit reported on secondary outcomes to influence results. Two-thirds of trials with serious side-effects under-reported them, particularly when the treatment showed a positive outcome. The authors call for improved reporting guidelines.
The REBORNE project aims to develop new biomaterials that stimulate bone tissue formation with the use of mesenchymal stem cells. Clinical trials will be conducted in France, Spain, Germany, and Italy to evaluate the safety and efficacy of this treatment for delayed union fractures.
Thousands of melanoma patients are undergoing sentinel node biopsy despite a lack of clear evidence, with up to 96% of cases resulting in unnecessary surgery. The BMJ calls on funders and researchers to demand prompt publication of the full results of the MSLT-I trial.
A new 33-item protocol checklist has been released to enhance trial protocols' content and quality, providing crucial information for critical appraisal and interpretation.
A new study found that patients receiving implantable heart defibrillators in everyday practice have similar survival benefits to those who received the same devices in clinical trials. The study used data from a large national Medicare registry and compared over 5,300 real-world patients against more than 1,500 trial participants.
A new meta-analysis of 10 studies involving over 203,000 patients with anemia and heart attacks found that liberal blood transfusions increased the risk of death by 12% and had twice the odds of another heart attack. The study calls for rigorous randomized trials to determine when transfusions are appropriate.
A 10-year follow-up study shows promising outcomes for patients who received gene therapy to rebuild their blood vessels. The five- and 10-year survival rates were comparable to those of patients treated with traditional medical therapy, with some cases showing improved outcomes.
A recent fMRI study published by David Eagleman in Frontiers found that ordinal sequences, such as numbers, have a strong spatial quality and stimulate less brain activity than non-ordinal sequences. This suggests that the brain can predict and process familiar sequences more efficiently, leading to reduced neural activity.
A new study by the American Academy of Neurology reveals that people without a spouse are underrepresented in Alzheimer's disease clinical trials. The study found that participants with adult child partners were more likely to be from diverse backgrounds, while those with spouse partners were more likely to be white and older.
Researchers found that non-spouse caregivers are less likely to participate in Alzheimer's clinical trials, citing higher dropout rates and adverse events. The study highlights the need for tailored recruitment efforts to increase enrollment of patients with diverse caregiver arrangements.
A new study published in the Journal of Urology found that robotic-assisted laparoscopic radical cystectomy (RARC) resulted in decreased estimated blood loss and shorter hospital stays compared to open radical cystectomy (ORC) for patients with muscle-invasive bladder cancer. RARC also showed a trend towards faster return of bowel func...
A new UCLA study assesses the prevalence of various study partner types in Alzheimer's clinical trials, finding that non-spouse partners can impact trial results and interpretations. The study also highlights disparities in recruitment among minority groups.
The conference, organized by IRB Barcelona and the BBVA Foundation, brings together experts to discuss the virtues of statistics for biomedical applications and present current state of the discipline. Biostatistics is applied to clinical assays, scrutinizing huge amounts of data and integrating information from diverse sources.
Researchers have developed a novel method for screening ALK fusions in non-small cell lung carcinoma (NSCLC) that is sensitive, specific, and economical. The new test offers a high-throughput and cost-effective screening modality compared to existing tests.
A new study suggests that age affects treatment outcomes for chronic lymphocytic leukemia (CLL) patients. Researchers found that optimal therapy differs between younger and older patients, with CD20 antibody therapies showing promise as front-line treatment for all CLL patients regardless of age.
The 'Smart stethoscope' assesses the effectiveness of shock wave lithotripsy treatment for kidney stones by analyzing echoes after each shock wave hits the stone. This device has been shown to achieve high accuracy (94.7%) in clinical trials, reducing the need for repeat therapy and x-ray monitoring.
Researchers at Georgia Tech have created Access4Kids, a wireless input device that translates physical movements into fine-motor gestures to control tablets. The device allows children with fine motor impairments to access off-the-shelf apps and custom-made apps for therapy and science education.
Researchers examined current treatment standards for patients with clotting disorders, aiming to reduce toxicities and relapse rates. Maintaining hematocrit levels below 45% was associated with a lower risk of thrombosis compared to a more liberal approach.
A new method of prenatal testing using microarray technology is providing physicians with more comprehensive results than conventional karyotyping, according to George Washington University researchers. The study found that microarray analysis can identify additional abnormalities not detectable by karyotyping, allowing for earlier int...
A review of existing studies found vitamin D associated with a significant reduction in tooth decay incidence in children. The findings support the importance of vitamin D for dental health and suggest a potential preventive role.
Researchers found fewer benefits associated with aldosterone antagonist drugs, including no difference in deaths or hospital readmissions for cardiovascular events. However, patients taking the drugs were at higher risk of hyperkalemia and less likely to be readmitted to the hospital for heart failure.
Two studies investigate heart failure therapies, finding varying outcomes regarding mortality rates among older patients. RAS antagonists are associated with improved survival in patients with preserved ejection fraction, while aldosterone antagonist therapy shows limited effectiveness.
Rates of hemorrhage for older warfarin patients are significantly higher than reported in clinical trials. Hemorrhage rates were found to be 11.8% in the first 30 days and 3.8% over a 13-year period.
The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials provides detailed guidance on CRTs, addressing issues such as informed consent, risk-benefit assessments, and data management. Researchers can benefit from this new framework to improve the ethical quality of their cluster randomized trials.
A prospective trial evaluated HBO2 therapy on post-concussion symptoms in military servicepersons with at least one combat-related mild TBI. Both treatment groups showed significant improvement in concussion assessment and cognitive testing scores over the course of the study.
A tiny medical device no larger than an eyelash significantly reduces eye pressure in glaucoma patients, with 100% of participants experiencing reduced IOP. The device may allow some patients to stop using eye drop medications, offering a promising alternative treatment for this common disease.
The RTS,S malaria vaccine candidate has shown promising results, reducing clinical and severe malaria episodes by one-third in African infants. The vaccine demonstrated an acceptable safety and tolerability profile, with side effects primarily including local injection site reactions.
A study by Thomas Jefferson University researchers found that deviating from radiation therapy protocols increases the risk of treatment failure and mortality. The analysis of eight large clinical trials revealed a significant association between protocol deviations and inferior clinical outcomes.
The radial approach has been shown to significantly reduce the incidence of major bleeding and access site complications compared to the femoral approach. In STEMI patients undergoing primary PCI within 12 hours, radial access was associated with a lower rate of major adverse cardiovascular events.
A large-scale clinical trial found that PFO closure using the Amplatzer PFO Occluder reduces recurrent ischemic strokes compared to standard medical therapy. The study enrolled 980 patients with documented cryptogenic embolic strokes and followed them for nearly nine years.
The PC Trial found that catheter-based PFO closure using an investigational device did not decrease ischemic and bleeding events compared to standard medical therapy. Stroke risk was non-significantly reduced with device therapy, with a relative risk reduction of 37 percent.
The RESPECT trial found that PFO closure significantly reduces the risk of recurrent ischemic strokes, with a clinical benefit of 46.6-72.7% compared to medical management alone. The study also showed low device-related risks and no device-related thrombus or embolization.
The FAME 2 trial demonstrated that FFR-guided percutaneous coronary intervention (PCI) is a cost-effective strategy compared to medical therapy for patients with stable coronary artery disease (CAD). This approach improves clinical outcomes and quality of life, with a projected cost-effectiveness of $53,000 per quality-adjusted life year.
The PARTNER Cohort B trial found TAVR to be beneficial for patients with severe aortic stenosis, with lower mortality rates and fewer cardiac deaths at three years compared to standard therapy. The study confirms the role of TAVR as the standard-of-care for symptomatic patients who are not surgical candidates.
The TRILOGY ACS trial found prasugrel did not reduce cardiovascular events among patients managed medically for acute coronary syndrome. However, it was associated with lower rates of cardiovascular disease, heart attack, and stroke, but higher rates of bleeding when compared to clopidogrel.
A study found that a nitinol stent performed better than balloon angioplasty alone in treating blockages of the popliteal artery, with higher one-year primary patency rates. The trial compared primary nitinol stent placement to angioplasty alone in patients with single obstructive lesions in the popliteal artery.
A study published in the New England Journal of Medicine found that ustekinumab increased clinical response and remission in patients with moderate-to-severe Crohn's Disease. The treatment was shown to decrease debilitating symptoms such as diarrhea, intestinal bleeding, and weight loss.
Researchers at Moffitt Cancer Center have developed a promising treatment approach for metastatic melanoma using chemotherapy and adoptive cell transfer (ACT) with tumor-infiltrating lymphocytes (TIL). The therapy achieved an impressive response rate of 38% in patients. A second-generation ACT TIL trial is currently enrolling patients.
A study published in the Journal of Thoracic Oncology found that VeriStrat can predict response to erlotinib, but does not provide a survival benefit. The test showed a significant difference in median survival between good and poor responders, with good responders experiencing longer survival on erlotinib.
A portable normothermic perfusion device has been tested on a group of twelve transplant patients, showing safe and effective preservation of donor lungs. The device has the potential to greatly improve transplant success and expand the pool of adequately-functioning donor lungs.
A randomized clinical trial of 377 premature babies found that receiving fresher blood did not improve clinical outcomes, including major organ injury, mortality, and infection. The study, led by Dr. Dean Fergusson, used the gold standard of medical science and challenged existing beliefs about fresh blood being better.
A Canadian research team led by Dr. Michael Hill has successfully conducted the world's first clinical trial to protect the brain from stroke damage using a neuroprotectant drug, NA-1. The trial showed promising results, reducing brain damage and improving neurological outcomes in patients who underwent endovascular aneurysm repair.
A new clinical trial at Loyola Medicine uses a genetically engineered immune system to fight melanoma. The treatment involves removing killer T cells from a patient and modifying them to recognize tumor cells as abnormal.
Researchers have found that one year of treatment with trastuzumab is as good as two years of treatment, improving outcomes and reducing the risk of disease recurrence. This conclusion comes from the HERA trial, which involved over 5100 women with early HER2-positive breast cancer.