Articles tagged with Clinical Trials
The US Food and Drug Administration (FDA) has found that failure to monitor progress according to the stated schedule was the most common concern among clinical trial sponsors, followed by failure to obtain the agreement of the principal investigator. Poor record keeping was also a significant issue, with 40% of warnings related to it.
A new research approach could improve medical study recruitment by adjusting treatment odds based on early results. In a recent study, patients shown an explanation of the odds were more willing to participate, with 67% volunteering compared to 54% without such explanation.
A new study found that red blood cell transfusions may benefit patients at high risk of death after trauma, but harm those at low risk. The study analyzed data from the CRASH-2 trial, which included 20,127 trauma patients from 40 countries.
A meta-analysis of 16 trials found thrombolytic therapy to be associated with a 47% lower odds of death, but also increased risk of major bleeding and intracranial hemorrhage. The study also showed lower rates of recurrent pulmonary embolism in patients treated with thrombolysis.
A clinical trial in China found that consuming broccoli sprout beverage daily increased excretion of benzene and acrolein, two known human carcinogens and lung irritants. The study suggests that sulforaphane from broccoli sprouts may activate a protective signaling molecule to adapt to environmental toxins.
A new version of a bionic pancreas device has been tested in two clinical trials, regulating blood sugar in patients with type 1 diabetes using insulin and glucagon. The device adapts to individual needs and prevents hypoglycemia, producing positive results in both adult and adolescent trials.
The first patient has been enrolled in the PROSPECT II clinical trial, a study that aims to assess the ability of intracoronary near infrared spectroscopy (NIRS) to identify non-flow obstructing vulnerable plaques. The trial will enroll 900 patients with acute coronary syndrome and follow them for up to 15 years.
A large, multi-site clinical trial will test new patient-centered strategies to prevent fall-related injuries. The trial aims to develop and implement individualized care plans for adults at high risk of falling.
The NSU College of Optometry will conduct the Convergence Insufficiency Treatment Trial—Attention and Reading Trial (CITT-ART), a national multi-center clinical trial investigating the impact of convergence insufficiency on attention and reading performance in children. The study aims to develop new therapies for children with attentio...
The European Society of Cardiology emphasizes the importance of patient-reported outcomes (PROs) in cardiovascular clinical trials. PROs provide valuable information on aspects of life beyond survival, influencing health technology assessments and reimbursement decisions.
A large, multi-site trial will test individually tailored interventions to prevent fall-related injuries in older adults. The study aims to improve the lives of those at risk for falls by integrating proven strategies into a cohesive intervention that can be adopted by healthcare systems.
Two recent JAMA Surgery studies investigate bariatric surgery as a treatment option for type 2 diabetes in obese patients. The studies found that bariatric surgery can lead to significant weight loss and improvements in blood sugar control, suggesting it may be an effective adjunctive therapy for managing the condition.
A new study suggests revising the definition of kidney disease progression used in clinical trials could shorten trial length and encourage more trials. This revised definition, based on a decline in estimated kidney function, carries higher risks for end-stage renal disease and mortality but is common enough to facilitate testing.
Researchers found that smaller declines in estimated GFR are strongly associated with subsequent risk of end-stage renal disease. A new definition of kidney disease progression could shorten clinical trials and improve treatment outcomes.
A study found that preventive implantation of ICDs in patients with less severe heart failure (LVEF 30-35%) significantly reduces mortality rates at 3 years compared to those without an ICD. The analysis also showed improved survival in patients with LVEF < 30%.
A chemotherapy regimen after radiation therapy improved progression-free survival and overall survival in adults with low-grade gliomas by an average of 5.5 years compared to radiation alone. The study, RTOG 9802, also found better outcomes for patients with oligodendroglioma and females.
The ALTTO trial showed that adding lapatinib to trastuzumab and chemotherapy did not improve patient outcome, while increasing toxicity. Researchers suggest standard adjuvant treatment should remain trastuzumab with chemotherapy for early stage HER2-positive breast cancer.
Indiana University researchers found that athletes can improve their performance even after being tricked, highlighting the brain's role in regulating exercise intensity. The study involved 14 trained cyclists who rode stationary bikes while being shown fake data, resulting in a 2.1% average improvement over baseline.
An analysis of 600 American College of Cardiology/American Heart Association guideline recommendations found that 80% were retained at the next revision, while those not supported by multiple randomized studies were more likely to be downgraded. The study suggests the need for frequent re-evaluation of practices and policies based on g...
A study published in JAMA found that participation in a structured moderate-intensity physical activity program significantly reduced the risk of major mobility disability among older adults. The study, known as LIFE, involved 818 participants who were randomly assigned to either an exercise group or a health education program.
A new Ebola vaccine has been successfully tested on captive chimpanzees, producing a robust immune response and showing safety. The researchers argue that this could be a turning point in saving endangered ape species from extinction, but the need for captive chimps testing raises ethical concerns about animal welfare.
Two studies on bronchiolitis treatments yield conflicting results, with one finding less improvement in infants after nebulized hypertonic saline treatment and the other showing decreased hospital admissions. The editorial dissects the contradictory evidence, suggesting chance or differences in study design may be to blame.
The INBRACED initiative has awarded a $400,000 grant to launch an international phase I clinical trial for children with relapsed or refractory neuroblastoma. The vaccine targets the GD2 and GD3 antigens and has shown promising results in children with neuroblastoma in the US.
The EORTC will present nine abstracts at the ASCO 2014 Annual Meeting, highlighting significant findings in bladder cancer, melanoma, and soft tissue sarcoma. The studies show improvements in progression-free survival for patients with muscle-invasive bladder cancer and adjuvant chemotherapy efficacy in melanoma.
The investigational vaccine generates an immune response against key toxins in volunteers and establishes a dosing regimen for Phase III trials, which could help prevent first-occurrence CDI and protect individuals from this potentially life-threatening infection.
The IN-TIME trial found that home telemonitoring reduces mortality and worsening clinical outcomes in both ICD and CRT-D patients. Patients with advanced heart failure and low ejection fractions reap similar benefits from this technology, suggesting it may be a valuable treatment option.
Cancer research calls on institutions to increase Hispanic patient enrollment, highlighting health disparities and underrepresentation in clinical trials. The study emphasizes the need for adequate representation to ensure effective treatment and reduce disparities.
A study including high-risk patients undergoing major gastrointestinal surgery found that using a cardiac-output guided intervention to improve hemodynamics did not reduce complications and risk of death after 30 days. However, an updated meta-analysis suggested a clinically important reduction in complication rates when the results we...
Despite improvements in supportive care, the mortality rate remains high due to sepsis. Statin therapy showed no significant difference in outcomes for patients with sepsis and ARDS, highlighting the need for further research into alternative treatments.
The RELAX-AHF trial found that poor diuretic response is associated with worse in-hospital and post-discharge clinical outcomes. Patients who do not respond well to diuretics have less relief from dyspnoea and a higher risk of cardiovascular death or rehospitalisation.
A review and meta-analysis found that consuming higher amounts of added sugars increases blood pressure and lipids, contributing to cardiovascular risk. The study's findings support reduced sugar consumption as a measure to combat global cardiovascular disease burden.
A study finds that clinical trial outcome data is often missing or inconsistent in global databases, making it challenging to access unbiased results. The investigators propose strategies to improve reporting, including simpler trial registration and uniform posting of results on registries.
A 1993 trial found no survival advantage in second look surgery for colorectal cancer patients with high CEA levels. The new analysis confirms this finding, despite methodological changes over the past two decades.
The University of Chicago Medicine Comprehensive Cancer Center has been awarded a five-year, $3.9-million grant to serve as a Lead Academic Participating Site for the National Clinical Trials Network. The new network aims to improve cancer clinical trials' speed and efficiency.
Beaumont Children's Hospital has been awarded a $20,000 grant from CureSearch to support therapeutic clinical trials for children with cancer. The hospital believes that clinical trials are essential in helping children with cancer, and this funding will enable them to open additional studies and reach more patients.
The Women's Health Initiative (WHI) estrogen plus progestin (E+P) trial resulted in a net economic return of $37.1 billion over 10 years, with $26.4 billion attributed to medical expenditure savings and $10.7 billion representing additional quality-adjusted life expectancy.
A study published in Annals of Internal Medicine found that Massachusetts' comprehensive health care reform led to a significant decline in deaths, particularly among nonelderly residents. The researchers estimated that the reform prevented 320 deaths per year and saved one life for every 830 persons gaining insurance. Additionally, th...
The Minneapolis Heart Institute Foundation has successfully implanted the world's smallest cardiac pacemaker as part of a global clinical trial. The Medtronic Micra Transcatheter Pacing System is a miniature device that delivers electrical impulses to pace the heart through an electrode, eliminating the need for surgical wires.
A practical risk-management approach has been outlined by the NCI, NCRI and EORTC to integrate biomarkers into cancer clinical trials. The approach aims to promote quality, facilitate data exchange and accelerate research while respecting local approaches and legislation.
The review provides guidance on managing surgical patients taking new oral anticoagulants, including discontinuation before procedures and resuming after procedures, as well as dose reductions based on kidney function and liver dysfunction considerations.
A study by Penn Medicine experts found significant geographic hotspots of increased stroke mortality in the US, with isolated areas of high and low mortality rates within these hotspots. Additionally, women are less likely to receive clot-busting rt-PA treatment at Primary Stroke Centers and non-Primary Stroke Centers, highlighting dis...
The prescription of testosterone in older men is associated with unclear cardiovascular risk. Despite the benefits in younger men, ongoing studies are unlikely to provide reliable safety data due to limited sample sizes and power.
Dartmouth has been awarded a grant to serve as a Lead Academic Participating Site in the National Clinical Trials Network, aiming to streamline clinical trial operations and improve access to new treatments. The network's goals include faster trial design, optimal use of scientific innovations, and expanded patient participation.
A new meta-analysis suggests that vitamin D supplements do not prevent falls by 15% or more, leaving uncertainty about their benefits for vulnerable older people. The analysis of 20 randomised controlled trials involving over 29,500 participants found no evidence to support the use of vitamin D supplements to reduce fall risk.
A study published in JAMA Network found that the medication acetazolamide, combined with a low-sodium weight-reduction diet, improved vision in patients with idiopathic intracranial hypertension. The treatment resulted in modest improvement in visual loss compared to a placebo.
Researchers at Cedars-Sinai Medical Center will conduct a Phase II clinical trial to evaluate the safety and efficacy of 3K3A-APC, an experimental drug combining with rtPA to treat ischemic strokes. The study aims to reduce risks and improve outcomes for stroke patients.
Researchers at Michigan State University have developed a promising new treatment for Parkinson's disease using a molecular tweezer that prevents protein aggregation. The molecule, CLR01, speeds up protein reconfiguration and has shown success in slowing the first step of aggregation, paving the way for clinical trials.
A clinical trial by UC researchers found that consuming chips with olestra reduces serum polychlorinated biphenyls (PCBs) levels in people exposed to PCBs. Olestra's effect on PCB removal is attributed to solubilizing fat-soluble compounds in the intestine, reducing absorption of these compounds into the body.
The Brain Health Registry aims to create a ready pool of research subjects for studies on neurological diseases, reducing costs and increasing efficiency. Volunteers will provide personal history and take online neuropsychological tests, helping scientists analyze brain functions over time.
A study of 1228 women found that low-dose aspirin did not improve live birth rates or reduce pregnancy loss, but showed benefits for those who had experienced a single pregnancy loss within the previous year. Women should consult their healthcare providers before taking any medication while trying to conceive.
A study found that restrictive RBC transfusion strategies reduce the risk of health care-associated infections by 11.8% compared to liberal strategies. Patients with specific conditions, such as orthopedic surgery or sepsis, also benefited from restrictive transfusions.
A recent study found that clinical trials often report adverse events less frequently on government websites compared to peer-reviewed medical journals. Inconsistent reporting of primary outcomes and deaths also occurred, highlighting the need for more comprehensive information on ClinicalTrials.gov.
A recent study published in JAMA compared two types of heart valve technologies used in transcatheter aortic valve replacement (TAVR) procedures. The researchers found that balloon-expandable valves had a higher rate of device success, with lower rates of complications such as regurgitation and the need for additional surgeries.
Researchers found that fewer than 30% of stroke survivors maintained consistent blood pressure control over time. Maintaining controlled blood pressure can reduce the rate of a second stroke by as much as 54% in individuals with elevated blood pressure at baseline.
The CHAMPION PHOENIX trial found cangrelor significantly reduces stent thrombosis (ST) at 48 hours and 30 days, associated with lower mortality. Cangrelor also improves freedom from ST at 30 days in various categories of ST.
The EORTC trial 62012 found that adding ifosfamide to doxorubicin improved median progression-free survival, but not overall survival or tumor shrinkage, in advanced soft tissue sarcoma patients. Combination chemotherapy also resulted in more overall responses compared to doxorubicin alone.
A clinical trial found that nurses can effectively treat common arm injuries in children, with an 85% success rate. However, physicians outperformed nurses with a 97% success rate, reducing the injury's length of stay by 55 minutes.
The HSV-2 vaccine candidate, GEN-003, generated highly significant reductions in clinical lesion days and rate of viral shedding at six months after the final vaccine dose. The study showed a 72% reduction in lesion days and a 50% reduction in mean viral shedding from baseline.
Researchers have discovered a genetic variant linked to an increased risk of stroke and cardiovascular disease. The study found that variants in the FOCM pathway, which regulates homocysteine metabolism, are associated with differences in methionine processing, highlighting potential new targets for disease prevention and treatment.
Researchers are testing whether early medical intervention can slow down progression of Alzheimer's disease before symptoms emerge. The A4 trial involves enrolling individuals at risk for Alzheimer's, who will be told of their risk status and monitored for potential adverse reactions.