Feature Channels: Clinical Trials

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People who suffer cardiac arrest usually have low likelihood of survival, especially if it happens out of the hospital.

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Expressive language sampling yielded five language-related outcome measures that may be useful for treatment studies in intellectual disabilities, especially fragile X syndrome. The measures were generally valid and reliable across the range of ages, IQs and autism symptom severity of participants. According to the study, led by UC Davis researchers and funded by NIH, the measures are also functional in supporting treatments that can improve language, providing far reaching benefits for individuals with intellectual disabilities.

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Key factors must be taken into account in determining the need for and allocation of scarce ventilators during a severe pandemic, especially one causing respiratory illness.

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Next generation genetic sequencing – or next generation sequencing (NGS) – is becoming more common in research, although it still isn’t widely available. At the UNC School of Medicine, it is part of a research collaboration to better understand viral lung infections, including COVID-19 – the novel coronavirus sweeping the world.

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A new study from Washington University School of Medicine in St. Louis suggests that the age of certain immune cells used in immunotherapy plays a role in how effective it is. These cells — natural killer (NK) cells — appear to be more effective the earlier they are in development, opening the door to the possibility of an immunotherapy that would not utilize cells from the patient or a matched donor. Instead, they could be developed from existing supplies of what are called human pluripotent stem cells.

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New study finds gene therapy improved cardiac, muscle and liver function in Danon disease mouse models.

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Physicians describe the standardized procedure of surgical anesthesia for patients with COVID-19 infection requiring emergency surgery to minimize the risk of virus spread and reduce lung injury in a Letter to the Editor published in Surgical Infections, a peer-reviewed journal from Mary Ann Liebert, Inc. publishers.

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Researchers from the University of Kentucky’s College of Medicine are leading a clinical study that could provide a promising new method for early detection of Parkinson’s disease.

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Available evidence supports the use of marked changes in urine oxalate in CKD stages 1-3a and plasma oxalate in CKD stages 3b-5 as surrogate end points for clinical trials in primary hyperoxaluria. Worsening kidney function is considered an acceptable clinical trial end point; however in many patients with primary hyperoxaluria, kidney function is not lost at a rapid rate until very advanced stages of disease. Kidney stones are clinically meaningful, though lack sufficient standards for measurement and monitoring. Their role as a feasible clinical end point should be reconsidered as more data becomes available.

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Keck Medicine of USC urologists are launching a clinical trial to evaluate the effectiveness of spinal cord stimulation in patients with an overactive bladder due to neurological conditions, such as a spinal cord injury or stroke, and idiopathic (unknown) causes.

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Based on proof-of-concept results from clinical trials at University of North Carolina Lineberger Comprehensive Cancer Center and Baylor College of Medicine, an investigational cellular immunotherapy for Hodgkin lymphoma has received a Regenerative Medicine Advanced Therapy designation from the U.S. Food and Drug Administration.

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Gut bacteria can penetrate tumor cells and boost the effectiveness of an experimental immunotherapy that targets the CD47 protein.

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Jim James enrolled in a UCLA Health clinical trial to treat melanoma that spread in his lungs and liver. Today, most of the tumors have diminished in size by at least 50% and there’s no trace of any new tumors.

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In the past, biologically-active peptides – small proteins like neurotoxins and hormones that act on cell receptors to alter physiology – were purified from native sources like venoms and then panels of variants were produced in bacteria, or synthesized, to study the structural basis for receptor interaction. A new technique called zombie scanning renders these older processes obsolete.

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BIDMC clinician-researchers provide new evidence about the optimal way to treat patients who carry BRCA mutations who have been diagnosed with breast cancer.

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An artificial intelligence (AI) device that has been fast-tracked for approval by the Food and Drug Administration may help identify newborns at risk for aggressive posterior retinopathy of prematurity (AP-ROP). AP-ROP is the most severe form of ROP and can be difficult to diagnose in time to save vision.

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A $6 million grant from Arnold Ventures will support replication and rigorous study of the outcomes of the Transitional Care Model (TCM) in four U.S. health care systems. Designed by a team at the University of Pennsylvania School of Nursing (Penn Nursing), the TCM has been proven in multiple National Institutes of Health (NIH)-funded randomized clinical trials (RCTs) to improve health outcomes, reduce rehospitalizations and decrease total health care costs among the growing population of Medicare beneficiaries.

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Only 1 in 13 everyday patients could have participated in a pivotal international clinical trial looking at the use of catheter ablation to treat atrial fibrillation (AFib) among people with heart failure. However, new Mayo Clinic research provides evidence supporting the benefit of ablation, and shows what the outcomes might be for everyday patients. The Mayo study will be published in Heart Rhythm Journal.

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Doctors face a difficult decision when they must choose a drug combination that will benefit the person sitting before them in an exam room. Statistics can’t show how any one person will respond to a reatment.works in people. Dr. Sarah Adams is using a $1.2M to find better ways to predict which women will benefit from her drug combination, now in clinical trials.

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A new study will evaluate whether persistent symptoms following concussion, also known as post-concussion syndrome, can be treated using a personalized, progressive aerobic exercise program. Data from this ongoing study by researchers at the University of Calgary will be presented this week at the Association of Academic Physiatrists Annual Meeting in Orlando.

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The density of immune cells, called tumor infiltrating lymphocytes, when combined with analysis of tumor budding may serve as a method to more accurately predict survival in patients with stage III colon cancer. The findings, by a team of researchers led by Mayo Clinic gastroenterologist and oncologist, Frank Sinicrope, M.D., were published today in Annals of Oncology.

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Researchers at the University of Texas Southwestern Medical Center and University of Chicago have discovered that bacteria that usually live in the gut can accumulate in tumors and improve the effectiveness of immunotherapy in mice. The study, which will be published March 6 in the Journal of Experimental Medicine (JEM), suggests that treating cancer patients with Bifidobacteria might boost their response to CD47 immunotherapy, a wide-ranging anti-cancer treatment that is currently being evaluated in several clinical trials.

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Mount Sinai researchers have designed an artificial intelligence model that can determine whether lower back pain is acute or chronic by scouring doctors’ notes within electronic medical records, an approach that can help to treat patients more accurately, according to a study published in the Journal of Medical Internet Research in February.

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As hospitalized COVID-19 patients undergo experimental therapy, research published in the Journal of Biological Chemistry explains how the drug, remdesivir, stops replication in coronaviruses.

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A new phase II trial finds that a combination of radiation therapy and immunotherapy led to encouraging survival outcomes and acceptable toxicity for patients with locally advanced head and neck squamous cell carcinoma (HNSCC). The combination of radiation and pembrolizumab may offer a new treatment option for patients who are ineligible for cisplatin chemotherapy, part of standard treatment for the disease. Findings will be presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.

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A new clinical trial suggests that immunotherapy given before other treatments for oral cavity cancers can elicit an immune response that shrinks tumors, which could provide long-term benefit for patients. In the randomized trial, two neoadjuvant doses of nivolumab given with or without ipilimumab led to complete or partial tumor shrinkage in most cases and did not delay any patients from continuing on to standard treatment. Findings will be presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.

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A targeted therapy drug used for breast and kidney cancers may also extend progression-free survival for patients with advanced head and neck cancer who are at high risk for recurrence after standard treatment. Patients enrolled in a randomized phase II trial who received the mTOR inhibitor everolimus were more likely to be cancer-free a year after therapy than those who took a placebo drug, and the benefit persisted for those with mutations in their TP53 gene.

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An international team of scientists, led by UC San Diego researchers, has developed a new, multi-sensor tool that measures subtle changes in multiple sclerosis patients, allowing physicians to more frequently and more quickly respond to changes in symptoms or patient condition.

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Non-small cell lung cancer (NSCLC) patients with higher measures of tumor mutations that show up in a blood test generally have a better clinical response to PD-1-based immunotherapy treatments than patients with a lower measure of mutations.

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The naturally occurring molecule N-acetylcysteine (NAC) shows benefit in a clinical trial for multiple sclerosis.

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Cardiologists at The Ohio State University Wexner Medical Center are the first in the U.S. to test a new type of ablation technology for patients suffering from atrial fibrillation, a common type of irregular heartbeat.

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Like most people, John Gifford wasn’t looking forward to a colonoscopy when he arrived on the UCI Medical Center campus in Orange in 2018. The Riverside man, 65, was concerned about his family history of colorectal cancer and had dutifully scheduled an appointment with UCI Health gastroenterologist Dr. William Karnes. The exam turned out to be intriguing and enlightening – a far cry from what one expects during a colonoscopy, Gifford recalls with a laugh.

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An experimental drug already shown to be safe and help some patients with clear cell renal cell carcinoma, a deadly form of kidney cancer, effectively disables its molecular target.

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Millions of people might eventually be spared the embarrassment and extreme isolation caused by wetting themselves, thanks to new research.

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Research from Rutgers Cancer Institute of New Jersey shows administering the immunotherapy drug pembrolizumab together with chemotherapy given at the same time as radiation treatment (chemoradiation) is safe and tolerable as a first-line therapy for patients with stage 3 non-small cell lung cancer (NSCLC).

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John Theurer Cancer Center at Hackensack University Medical Center is the only site in New Jersey and one of just 17 in the country participating in a multicenter international Phase II study of an innovative personalized cancer vaccine being evaluated in combination with pembrolizumab immunotherapy in patients with melanoma that has been surgically removed but has a high risk of coming back. The hope is that the vaccine can prime a patient's immune system to be more responsive to immunotherapy and reduce the risk of cancer recurrence.

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In experiments with human cells and mice, researchers at the Johns Hopkins Kimmel Cancer Center report evidence that combining the experimental cancer medication TAK228 (also called sapanisertib) with an existing anti-cancer drug called trametinib may be more effective than either drug alone in decreasing the growth of pediatric low-grade gliomas. These cancers are the most common childhood brain cancer, accounting for up to one-third of all cases. Low grade pediatric gliomas arise in brain cells (glia) that support and nourish neurons, and current standard chemotherapies with decades-old drugs, while generally effective in lengthening life, often carry side effects or are not tolerated. Approximately 50% of children treated with traditional therapy have their tumors regrow, underscoring the need for better, targeted treatments.

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The University of Chicago Medicine Comer Children's Hospital was one of the sites for a landmark clinical trial that led to approval of the first oral immunotherapy treatment for peanut allergy in children and teens.

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Loyola Medicine is among the first to conduct a clinical study using hypnotherapy to treat functional dyspepsia, a gastrointestinal disorder affecting approximately 10 percent of the population.

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We know that stress can have a profound impact on health. But it’s rare to discover a health issue that is caused directly by stress.  That’s exactly what one Michigan State University researcher and his team have found.  Nathan Tykocki, an assistant professor of pharmacology and toxicology in the College of Osteopathic Medicine, set out to understand why children who seemingly have nothing wrong with them lose bladder function, a condition also known as stress-induced bladder dysfunction, or SIBD.

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In a new Cleveland Clinic-led study published in JAMA Oncology, researchers show that a testosterone-related genetic variant – HSD3B1(1245C) – is associated with more aggressive disease and shorter survival in men with metastatic prostate cancer.

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In the early 90s, Dr. Jessie Casida was one of few nurses working on the first patient with a left ventricular assist device. The patient’s self-management responsibility was so complicated that it inspired him to create VADcare App.

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The researchers behind the early-stage work, published in JCI Insight, are exploring whether kisspeptin can ultimately be used to treat men with common psychosexual disorders - sexual problems which are psychological in origin such as low libido.

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In a new article published online ahead of print in Cancer Research, members of Moffitt’s Center of Excellence for Evolutionary Therapy present a case study of an adaptive treatment approach based on evolutionary principles in prostate cancer and suggest that these strategies may provide a path toward improved multidrug adaptive therapies.

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Researchers have lifted fertility rates in older female mice with small doses of a metabolic compound that reverses the ageing process in eggs, offering hope for some women struggling to conceive.

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Top-line data reported from international trial

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An anti-cancer compound developed at the University of Michigan has shown “profound” activity in mouse models against two subtypes of leukemia — representing up to 40% of patients — a U-M research team reports in the Journal of Clinical Investigation.

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A new study finds that one side effect of lupus could also make patients with the autoimmune condition more vulnerable to a skin infection, or spreading the infection to others.

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In the future, robots could take blood samples, benefiting patients and healthcare workers alike. A Rutgers-led team has created a blood-sampling robot that performed as well or better than people, according to the first human clinical trial of an automated blood drawing and testing device.

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Cancer-fighting compound fights obesity and diabetes: Eric Prossnitz, PhD, and his team reported that G-1, a cancer-fighting compound they discovered some years ago, reduces fat in obese mice. Although G-1 is currently in phase 1 clinical trials for cancer, Prossnitz and his team are planning preclinical studies to use G-1 to fight fat in obese people.