Articles tagged with Clinical Trials
Residents selectively extend work shifts to facilitate care transitions, stabilize critically ill patients, and perform routine responsibilities. However, senior residents reported more frequent duty hour violations, with junior residents having the highest rate of frequent violations.
Recent studies have yielded promising results for patients with type 2 diabetes, including a 21% reduced risk of kidney dysfunction or death. Remote ischemic preconditioning has also shown sustained improvement in kidney function after transplantation. Meanwhile, trials examining dialysate sodium levels and voclosporin treatment have o...
The updated guideline suggests that more breast cancer patients can benefit from accelerated partial breast irradiation (APBI), including younger patients and those with low-risk ductal carcinoma in situ (DCIS). The guideline provides direction for the use of intraoperative radiation therapy (IORT) for early-stage breast cancer patients.
Phage therapy, which uses viruses to kill bacteria, has shown no adverse effects in clinical trials and holds promise for treating antibiotic-resistant infections. Researchers plan to use phages against E. coli in the gut or MRSA on the skin, with a goal of establishing a central repository for phages.
Researchers at University of California San Diego School of Medicine found that ustekinumab induces response and remission in patients with Crohn's disease. The study showed high remission rates among patients treated with intravenous or subcutaneous ustekinumab.
Senior officials from the FDA and NIA joined advocates and researchers to discuss collaborations for advancing Alzheimer's disease knowledge into clinical trials. The meeting aimed to identify reliable biomarkers and symptomatic approaches to improve treatment of major behavioral and psychiatric aspects of the disease.
A team of researchers has developed a new prediction model that uses crowdsourced data from 550 international researchers to provide more accurate prognosis for patients with metastatic castration-resistant prostate cancer. The model, called ePCR, was developed through a collaboration between 16 institutions and used a computational le...
Researchers found that young adults with ADHD produced more force during continuous motor tasks and had difficulty inhibiting motor responses compared to those without ADHD. This study suggests that inhibitory motor control problems may be a unique identifier for adults with ADHD.
A national survey of US general surgery residents found that 86% preferred flexible duty hour policies over standard schedules, with a stronger preference among senior residents. The study also showed that flexible hours improved patient safety and continuity of care, and reduced resident dissatisfaction.
The RE-DUAL PCI study evaluates the safety and efficacy of dabigatran etexilate in AF patients undergoing PCI. This first-ever study to use a dual versus triple antithrombotic regimen with NOAC dosages already approved for stroke prevention will inform optimal anticoagulant choices for AF patients requiring PCI.
A new wearable medical device has been found to reduce visceral fat and improve blood glucose levels in patients with type 2 diabetes. The device, which uses mild electrical stimulation and heat shock, has shown significant improvements in glycated hemoglobin values and insulin resistance.
A clinical trial is testing a new device that could ease heart failure symptoms in patients with preserved ejection fraction. The Corvia Medical InterAtrial Shunt Device makes a small hole to redistribute blood and reduce pressure, allowing patients like Jimmy McMillan to breathe better and live more comfortably.
Researchers are testing stem cell therapy to reprogram heart cells in patients with HFpEF, a condition causing severe disability and high mortality. The trial aims to improve treatment options for this growing epidemic, which disproportionately affects women and African-Americans.
A new study by Mark J. Bolland and his team analyzed 33 randomized controlled trials, finding reported results that differed markedly from what could be expected statistically. The trials reported large reductions in hip fractures, but the findings are not consistent with results found in similar studies by other researchers.
The Walter Reed Army Institute of Research has begun a Phase 1 human clinical trial to test the safety and immunogenicity of the ZPIV vaccine, developed using an inactivated flavivirus vaccine platform. The trial involves 75 healthy adults and is part of the US Department of Defense response to the ongoing Zika virus outbreak.
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.