Articles tagged with Clinical Trials
The first of five clinical trials for an investigational Zika vaccine began at the Walter Reed Army Institute of Research, testing the safety and ability of the ZPIV vaccine to generate an immune system response. The Phase 1 trial aims to enroll 75 people aged 18-49 with no prior flavivirus infection.
A recent study published in the journal Stem Cells found that autologous stem cell therapy after traumatic brain injury appears to reduce inflammation and preserve critical brain regions. Researchers used this approach on 25 patients, including those with severe TBI, showing promising results.
The RESPECT trial found that percutaneously closing a patent foramen ovale (PFO) using the Amplatzer PFO Occluder was superior to medical management in preventing recurrent ischemic stroke. Key findings showed a 45% relative risk reduction in recurrent ischemic stroke for the PFO group.
A phase-1 clinical trial demonstrates that gene therapy can restore functional type-7 collagen protein expression and improve wound healing in patients with recessive dystrophic epidermolysis bullosa. The treatment appears safe and well-tolerated, with improved outcomes for patients who had not healed for five years.
The SENTINEL trial found that the Sentinel device was safe during TAVR but did not meet its primary efficacy endpoint of reducing median new lesion volume on MRI. Despite this, embolic protection resulted in a reduction of new lesion volume after adjusting for confounders.
The PLATINUM DIVERSITY trial found that women and minorities had higher rates of death and myocardial infarction after coronary stent procedures compared to white men. The study also highlighted the need for further research into the causes of these observed gradients of risk.
The Nordic-Baltic-British Left Main Revascularization Study (NOBLE) found that CABG reduced the five-year risk of MACCE compared to PCI for LMCA disease. The study demonstrated superiority of CABG over PCI in reducing non-procedural myocardial infarction and stroke.
The ILUMIEN III trial found that optical coherence tomography-guided PCI resulted in similar minimal stent area compared to IVUS-guidance, while also showing improved stent expansion and acute procedural success compared to angiography-guidance. Untreated major dissections were more common after IVUS-guided PCI than OCT-guided PCI.
A study found that nearly half of cancer patients expect their tumors to shrink after participating in phase I clinical trials, despite the realistic response rate being much lower. The results highlight the need to improve patient information and consent forms.
A new study from Johns Hopkins Medicine found that while training doesn't change neurological repair in chronic stroke patients, it can help them learn new motor skills and achieve more independence. The researchers used a video game-like test to assess the patients' ability to perform tasks.
A case report reveals that high-dose lutein supplements can cause the formation of crystal deposits in the eyes, highlighting the importance of balanced intake. The study suggests that patients should follow a diet rich in eye-healthy foods and only take AREDS2 supplements as recommended by their ophthalmologist.
Researchers found that unconscious increases in arousal affect participants' confidence in their visual decisions. This effect is counteracted by artificially increased arousal, suggesting a complex relationship between conscious introspection and physiological states.
The ECOG-ACRIN Cancer Research Group is recruiting medical facilities for the Tomosynthesis Mammography Imaging Screening Trial (TMIST), a large-scale breast cancer screening trial comparing digital breast tomosynthesis with standard digital mammography. The study aims to provide a modern basis for continued use of mammography.
A new trial found that offering patients a weight loss programme during a routine consultation is effective, with participants losing an average of 1.43kg more than those in the control group. The intervention was welcomed by patients and took only 30 seconds of physicians' time.
The new evidence-based clinical guideline from the National Osteoporosis Foundation and American Society for Preventive Cardiology says that calcium with or without vitamin D intake should be considered safe for generally healthy adults. Obtaining calcium from food sources is preferred, but supplements can be used to address dietary sh...
A recent study published in Journal of American Geriatrics Society found that increasing muscle strength can improve brain function in adults with Mild Cognitive Impairment. The SMART trial involved 100 community-dwelling adults who performed resistance exercise and showed significant improvements in global cognition and brain function.
The Cedars-Sinai Board of Governors Regenerative Medicine Institute is conducting the first human trial of a novel combined stem cell and gene therapy for ALS patients. The therapy aims to preserve leg mobility by providing supportive cells that produce glial cell line derived neurotrophic factor (GDNF).
Researchers developed a new international guideline to standardize clinical trial results reporting, increasing the efficiency and value of global research. The COS-STAR statement provides a checklist of 18 essential items for transparent and complete reporting in Core Outcome Set studies.
A multi-country randomized controlled trial will assess the impact of cleaner burning cooking stoves on household air pollution and health in four low- and medium-income countries. The study aims to provide compelling evidence for national and global policies to reduce household air pollution among vulnerable populations.
Three different candidate Zika vaccines have been found to protect rhesus monkeys against the disease in trials. The vaccines, tested in preclinical trials, were found to be effective at warding off infection by the Zika virus strain circulating in Brazil and Puerto Rico.
A study of 3,242 patients found that mesh use during incisional hernia repair reduced hernia recurrence risk over 5 years. However, the long-term benefits were partially offset by mesh-related complications. The study highlights the need for more research on the safety and efficacy of mesh in hernia repair.
A Phase 2 study of a novel colonoscopy prep found it to be at least as effective and safe as existing products, while offering higher levels of patient satisfaction and preference. The investigational treatment allows patients to eat solid food bars and drink palatable beverages, leading to nearly four times more recommendations.
A systematic review and meta-analysis of 19 randomized controlled trials found potential beneficial effects of flavanol-rich cocoa on cardiometabolic health. Flavanol intake may reduce dyslipidemia, insulin resistance, and systemic inflammation, which are major subclinical risk factors for cardiometabolic diseases.
The EPR-CAT study seeks to test whether rapid cooling of the body temperature can give surgeons extra time to find and repair injuries, improving patient outcomes. By decreasing oxygen demand, cooling may protect vital organs from permanent damage.
A new retrospective study found that men with prostate cancer treated with testosterone-lowering drugs are twice as likely to develop dementia within five years as those whose testosterone levels are not tampered with. The study used deidentified records from Stanford Medicine's clinical-research data warehouse and aggregated several f...
Research on grafting tomatoes in high tunnels found that grafted plants yielded significantly more than nongrafted controls, with yield increases ranging from 18% to 126%. The effect of scion shoot removal was not as consistent, but some trends suggest that rootstock vigor plays a role.
A clinical trial using allogeneic cardiosphere-derived cells will be conducted to test efficacy and safety for heart attack patients. The study aims to improve cardiac regeneration, ventricular function, and reduce scar tissue.
The updated AABB guidelines recommend a restrictive RBC transfusion threshold of 7-8 g/dl for hospitalized adult patients who are hemodynamically stable. The guidelines also suggest that patients should receive RBC units selected at any point within their licensed dating period, rather than limiting them to fresh units with a storage l...
The AABB has issued updated guidelines for red blood cell storage time and transfusion use, citing analysis of over 5,000 patients across 13 randomized clinical trials. The new recommendations suggest that stored blood is as safe as fresh blood for stable hospitalized patients.
The new guidelines, published by JAMA, were developed after comprehensive research using over 60 years of red blood cell transfusion data and 31 clinical trials. Transfusions at a lower level are recommended for critical care patients as well as those undergoing orthopedic and cardiac surgery.
A phase III trial found that MEK inhibition with selumetinib plus docetaxel did not improve progression-free or overall survival in KRAS-mutant non-small-cell lung cancer patients. The study concluded that there is a desperate need for new treatments for this subset of NSCLC patients.
The first controlled clinical trial of nicotinamide riboside (NR) demonstrated that the compound is safe for humans and increases levels of a critical cell metabolite. NR supplementation has been shown to produce multiple health benefits, including improved control of blood sugar and cholesterol.
A phase III randomized controlled trial of custirsen in combination with cabazitaxel/prednisone found no significant survival gains compared to the placebo arm. Custirsen blocks clusterin production, which is involved in carcinogenesis and treatment resistance.
In a phase III trial, nivolumab showed improved patient-reported outcomes, including reduced symptoms and maintained functional capacity, compared to standard chemotherapy. The study found that nivolumab not only prolongs life but also improves quality of life.
The CheckMate 141 trial found that nivolumab maintained or improved function and reduced symptoms in patients with relapsed metastatic head and neck cancer. In contrast, standard chemotherapy resulted in worse scores. Nivolumab's superior clinical activity also suggests fewer side effects, leading to a better quality of life for patients.
The phase III KEYNOTE-024 trial found pembrolizumab significantly improved progression-free survival by approximately four months compared to chemotherapy, with 80% of patients alive at six months on pembrolizumab. The treatment was also associated with a higher overall response rate and lower adverse events.
The ENGOT-OV16/NOVA trial shows niraparib significantly improves progression-free survival in recurrent ovarian cancer patients, with median survival rates up to 21 months. Niraparib also improves secondary endpoints, including time to first subsequent treatment and chemotherapy-free interval.
ResearchersAgainstAlzheimer's report reveals 57 new Alzheimer's drugs in Phase II testing, with nearly twice as many mechanisms of action being tested as in Phase III clinical trials. The analysis calls for changes to clinical trial infrastructure and endpoints to ensure rapid recruitment and effective testing.
Researchers identified individual strategies like mindfulness training and organizational changes such as limiting duty hours, which are effective in reducing physician burnout. The study's findings suggest that a combination of interventions may be needed for long-term benefits.
A randomized trial found no significant differences in rates of complications between observation and antibiotic treatment groups for uncomplicated diverticulitis. Patients who received antibiotics had shorter hospital stays compared to those who underwent observation.
A two-year study of over 37,800 live births in Zambia found that chlorhexidine washes did not reduce neonatal mortality, contradicting previous results in south Asia. The study suggests that the treatment may not be effective in lower mortality settings with more facility-based deliveries.
A study by NRG Oncology found that stereotactic body radiation therapy (SBRT) is safe and effective for medically inoperable patients with non-small cell lung cancer (NSCLC), particularly when using higher dose levels. The trial demonstrated comparable local control and outcomes data to SBRT results in peripherally located early stage ...
A new long-term analysis of prognostic factors among patients with breast cancer reveals that young age and ductal carcinoma in situ (DCIS) adjacent to invasive tumors are associated with increased ipsilateral breast tumor recurrence. High-grade invasive tumors also relapsed more frequently during the first five years.
Researchers at Brigham and Women's Hospital found that PSA failure increases the risk of death by 1.6-fold in healthy men, but not those with comorbidities like heart disease or stroke. The study suggests healthy men should be informed about clinical trials showing reduced PSA failure benefits.
The ENSURE-AF trial shows edoxaban as an effective and safe alternative to standard therapy, with comparable rates of stroke and bleeding events. Patients can start edoxaban 2 hours prior to cardioversion if they have access to transoesophageal echocardiography.
A first-of-its-kind randomized trial comparing two stenting techniques for coronary bifurcation lesions has found that culotte stenting is associated with lower rates of restenosis and revascularization. Culotte stenting demonstrated a statistically significant advantage over TAP stenting in terms of clinical outcomes.
A large-scale clinical trial found that non-vitamin K antagonist oral anticoagulants (NOACs) can be safely used as an alternative to warfarin before cardioversion in atrial fibrillation patients. Edoxaban was shown to be equally effective as current use of warfarin, and expedited the process from initial standard treatment.
A new clinical decision rule, HERDOO2, has been validated in the REVERSE II trial, enabling the identification of women at low risk for recurrent venous thromboembolism who can safely discontinue anticoagulants. The study found that over half of these women could stop taking anticoagulants without increasing their risk.
The CE-MARC 2 trial found that cardiovascular magnetic resonance (CMR) and myocardial perfusion scintigraphy (MPS) significantly reduced rates of unnecessary angiography compared to guideline-directed care. These findings suggest that functional imaging should be adopted on a wider basis, even in high-risk patient subgroups.
The CONSERVE trial found that non-invasive computed tomography (CT) can safely reduce costs by guiding more selective use of invasive coronary angiography. The study associated lower rates of invasive procedures and cost savings in stable symptomatic patients with suspected coronary artery disease.
An analysis of a multicenter randomized controlled clinical trial found osteopathic manipulative treatment (OMT) reduced length of hospital stay and lowered in-hospital mortality rates for elderly pneumonia patients. OMT was associated with improved outcomes, particularly in the subgroup with the highest severity of illness.
The MORE-CARE trial found that remote monitoring of cardiac devices did not improve hard clinical outcomes, but showed cost savings and reduced in-office visits, with a 41% reduction in healthcare resource utilization
A phase II-a randomized trial showed that intravenously administered mesenchymal stem cells resulted in improved health status and functional capacity in patients with chronic non-ischemic cardiomyopathy, but no significant cardiac structural or functional improvements were observed.
The NIPPON study found that shorter dual antiplatelet therapy (DAPT) is comparable to longer DAPT in terms of net adverse clinical and cerebrovascular events. A combination of short DAPT and a newer DES with bioabsorbable coating may minimize thrombotic events and bleeding complications.
The CHART-1 trial, a large-scale cardiovascular study, investigated the use of bone-marrow stem cells to treat congestive heart failure. Although findings were neutral in the overall patient population, an exploratory analysis identified a sub-group that may benefit from cardiopoietic cell therapy.
A recent study published by the European Society of Cardiology found that direct catheter-based thrombectomy is as effective as traditional thrombolytic treatment in treating acute ischemic strokes. The procedure was performed in a timely manner and resulted in comparable outcomes, with 41% of patients achieving good functional recover...
A clinical trial at the University of Iowa will compare the effects of two popular diets on multiple sclerosis-related fatigue. The 36-week trial will recruit 100 people with relapsing-remitting MS and follow their health for 24 weeks, monitoring their health and activities.
A clinical trial led by Jeff Elias at the University of Virginia Health System found that focused ultrasound is safe and effective in reducing shaking caused by essential tremor. Participants showed significant improvement in disabilities and quality of life, with mean tremor scores improving by 47% at three months.
Researchers at Mayo Clinic, along with the Geroscience Network, published six manuscripts mapping strategies for new drugs targeting aging processes. The goal is to treat multiple age-related diseases and disabilities, reducing healthcare costs by delaying or preventing conditions like stroke, heart disease, and dementia.
A recent study published in Annals of Internal Medicine has found that flu nasal sprays provide similar protection against influenza as standard flu shots. The study, conducted over three years in a Hutterite colony, shows that the nose spray had a similar effect to the standard flu shot in protecting both children and community members.