Current Clinical Trial Data News and Events

Current Clinical Trial Data News and Events, Clinical Trial Data News Articles.
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Monoclonal antibodies against MERS coronavirus show promise in phase 1 NIH-sponsored trial
A randomized, placebo-controlled Phase 1 clinical trial of two monoclonal antibodies (mAbs) directed against the coronavirus that causes MERS found that they were well tolerated and generally safe when administered simultaneously to healthy adults. The experimental mAbs target the MERS coronavirus (MERS CoV) spike protein used by the virus to attach to and infect target cells. The mAbs were discovered and developed by scientists at the biopharmaceutical company Regeneron. The trial was sponsored by NIAID. (2021-02-23)

Yale neurologists identify consistent neuroinflammatory response in ICH patients
Understanding how the immune system responds to acute brain hemorrhage could open doors to identifying treatments for this devastating disease. However, up until now, there has been limited information on inflammation in the brain from human patients, especially during the first days after a hemorrhagic stroke. This led a team of researchers to partner with a large clinical trial of minimally-invasive surgery to tackle defining the human neuroinflammatory response in living patients. (2021-02-22)

The Lancet: 3-month interval between first and second dose of Oxford COVID-19 vaccine results in higher vaccine efficacy than 6-week interval
* Exploratory analyses including 17,178 participants find that higher vaccine efficacy is obtained with a longer interval between the first and second standard dose (81% for 3-month interval vs 55% for up to 6-week interval). In addition, a single dose of vaccine is highly efficacious in the first 3 months (76% efficacy from 22 days after vaccination onwards). (2021-02-19)

New recommendations aim to eliminate racial bias in myeloma trials
Recommendations designed to address the under-representation of African Americans in clinical trials for multiple myeloma (MM), a blood cancer that is twice as deadly in this demographic as in whites. (2021-02-18)

Neoadjuvant combination immunotherapy improves outcomes for early stage non-small cell lung cancer
The first randomized Phase II clinical trial to report on single and combined neoadjuvant immune checkpoint inhibitor therapy in stage I-III non-small cell lung cancer (NSCLC) found combination therapy produced a significant clinical benefit. (2021-02-18)

Penn-developed CAR T therapy shows long-lasting remissions in non-hodgkin lymphoma
A significant number of non-Hodgkin lymphoma (NHL) patients in a Penn Medicine-initiated clinical trial continue to be in remission five years after receiving the chimeric antigen receptor (CAR) T cell therapy Kymriah™, researchers in Penn's Abramson Cancer Center reported today in the New England Journal of Medicine. (2021-02-17)

MSK physician shares kidney cancer research at annual ASCO GU Symposium
Memorial Sloan Kettering's Robert Motzer presented positive data from a phase III randomized study that assessed two different treatment combinations as first-line therapies that may benefit people with advanced kidney cancer. (2021-02-16)

CPAP treatment increases physical activity in adults with sleep apnea, heart disease
A new study found that treating obstructive sleep apnea with CPAP therapy increased self-reported physical activity in adults with a history of heart disease. (2021-02-16)

Unexpected findings on weight loss and breast cancer from international study in JNCCN
New research in the February 2021 issue of JNCCN--Journal of the National Comprehensive Cancer Network examined body mass index (BMI) data for people with HER2-positive early breast cancer, and found a 5% weight loss in patients over two years in was associated with worse outcomes. Weight gain over the same time period did not affect survival rates. (2021-02-16)

Challenge to anorexia nervosa treatment guidelines
New analysis published in The Lancet Psychiatry has shown a lack of strong evidence to support current guidance on psychological therapies for treating anorexia nervosa over expert treatment as usual. The findings highlight a need for further research and support a call for individual trial data to be made available so the benefits of treatments in specific patient populations can be better understood. (2021-02-15)

Cabozantinib most effective treatment for metastatic papillary kidney cancer
In a SWOG Cancer Research Network trial that put three targeted drugs to the test, the small molecule inhibitor cabozantinib was found most effective in treating patients with metastatic papillary kidney cancer - findings expected to change medical practice. (2021-02-13)

Immunotherapy -- targeted drug combination improves survival in advanced kidney cancer
Patients with advanced kidney cancer, who received a targeted drug combined with a checkpoint-blocker immunotherapy agent had longer survival than patients treated with the standard targeted drug, said an investigator from Dana-Farber Cancer Institute, reporting results from a phase 3 clinical trial. (2021-02-13)

Self-testing trebles HIV testing rate amongst trans people in randomised trial
HIV self-testing could reduce the time between HIV infection and HIV diagnosis amongst trans people when compared to standard testing services, suggests new research in EClinicalMedicine. The project was a collaboration between the London School of Hygiene & Tropical Medicine (LSHTM), University College London (UCL), and the Medical Research Council Clinical Trials Unit. It involved more than 100 trans men and trans women in England and Wales, and is the largest HIV self-testing trial in this community to be reported. (2021-02-11)

Low-income middle-aged African-American women with hypertension are likely to suffer from depression
Low-income middle-aged African-American women with high blood pressure very commonly suffer from depression and should be better screened for this serious mental health condition. (2021-02-11)

Rabies treatment demonstrated as safe and effective for use in children in first pediatric trial
A treatment, known as KEDRAB (Rabies Immune Globulin [Human]), currently used in the prevention of rabies has been demonstrated to be safe and effective for patients age 17 and under. (2021-02-10)

Virtual reality helping to treat fear of heights
Researchers from the University of Basel have developed a virtual reality app for smartphones to reduce fear of heights. Now, they have conducted a clinical trial to study its efficacy. Trial participants who spent a total of four hours training with the app at home showed an improvement in their ability to handle real height situations. (2021-02-10)

'Gamechanger' drug for treating obesity cuts body weight by 20%
One third (35%) of people who took a new drug for treating obesity lost more than one-fifth of their total body weight, according to a major global study involving UCL researchers. (2021-02-10)

Vegan diet better for weight loss and cholesterol control than Mediterranean diet
A vegan diet is more effective for weight loss than a Mediterranean diet, according to a groundbreaking new study that compared the diets head to head. The randomized crossover trial, which was published in the Journal of the American College of Nutrition, found that a low-fat vegan diet has better outcomes for weight, body composition, insulin sensitivity, and cholesterol levels, compared with a Mediterranean diet. (2021-02-05)

Drug 'breakthrough' gives longest-ever survival in nonresectable liver cancer patients
New follow-up data from a landmark study of liver cancer patients treated with a combination of an immunotherapy drug (atezolizumab) and a monoclonal antibody (bevacizumab) has shown the longest-ever survival time in a frontline phase 3 trial of systemic therapy in advanced hepatocellular carcinoma (HCC), demonstrating a 'major breakthrough' in the field. (2021-02-05)

Dual treatments help PTSD and depression
Reducing the severity of posttraumatic stress disorder (PTSD) and depression - an urgent concern in the era of COVID-19 lockdown and isolation traumas - may benefit from dual treatments rather than a single treatment protocol, according to Flinders University researchers. (2021-02-04)

Fecal microbiota transplants help patients with advanced melanoma respond to immunotherapy
For patients with cancers that do not respond to immunotherapy drugs, adjusting the composition of microorganisms in the intestines--known as the gut microbiome--through the use of stool, or fecal, transplants may help some of these individuals respond to the immunotherapy drugs, a new study suggests. Researchers at the NCI, part of the National Institutes of Health, conducted the study in collaboration with investigators from UPMC Hillman Cancer Center at the University of Pittsburgh. (2021-02-04)

Pharmacologist offers plan to solve disparities in designing medicine
In a new perspective piece published in the Feb. 5 issue of Science, Johns Hopkins pharmacologist Namandje Bumpus, Ph.D., outlines the molecular origins for differences in how well certain drugs work among distinct populations. She also lays out a four-part plan to improve the equity of drug development. (2021-02-04)

Preventive anti-clotting therapy does not boost survival of critically ill COVID patients
Although abnormal blood clotting has been identified as one of the primary causes of death from COVID-19, early treatment in an intensive care unit with therapeutic anticoagulation (anti-clotting) for adults who are critically ill with COVID-19 does not appear to improve chances of survival, and could do more harm than good by increasing the risk for major bleeding, a multicenter research group cautions. (2021-02-03)

BU study: New vaginal film, MB66, is safe
Researchers at Boston University School of Medicine (BUSM), Alpert Medical School of Brown University and Mapp Biopharmaceutical have now found that MB66, a vaginal film product containing monoclonal antibodies against human immunodeficiency virus-type 1 (HIV-1) and herpes simplex viruses types 1 and 2 (HSV-1 and 2), is safe and effective. (2021-02-03)

First-in-human clinical trial confirms HIV vaccine approach by IAVI and Scripps Research
A phase 1 clinical trial testing a novel vaccine approach to prevent HIV has produced promising results, IAVI and Scripps Research announced today. The vaccine showed success in stimulating production of rare immune cells needed to start the process of generating antibodies against the fast-mutating virus; the targeted response was detected in 97 percent of participants who received the vaccine. (2021-02-03)

X-Stop® vs Laminectomy for lumbar spinal stenosis: Quality of life and cost-effectiveness
A randomized controlled trial of the X-Stop® interspinous distractor device and open laminectomy in patients with lumbar spinal stenosis. Both procedures improved the patients' quality of life; however, overall, laminectomy gave patients a better quality of life and was also more cost-effective. (2021-02-02)

Test for early detection of heart problems reduces risk of heart damage from chemotherapy
Results of a multi-centre, international, clinical trial co-led by Peter Munk Cardiac Centre (PMCC) cardiologist Dr. Dinesh Thavendiranathan point to the benefit of using a more sensitive test to detect heart function issues early, so cancer patients don't have to fight heart failure too. (2021-02-02)

The Lancet: Study reports preliminary efficacy and safety results from interim analysis of Russian COVID-19 phase 3 vaccine trial
An interim analysis of data from the phase 3 trial of the COVID-19 vaccine from Russia (Gam-COVID-Vac) suggests that a two-dose regimen of the adenovirus-based vaccine offers 91.6% efficacy against symptomatic COVID-19. The preliminary findings, published in The Lancet, are based on analysis of data from nearly 20,000 participants, three-quarters of whom received the vaccine and one quarter received a placebo. (2021-02-02)

Neuromuscular disease registry helps patients access research, clinical trials, new genetic tests, and therapies
Amsterdam, February 2, 2021 - The Canadian Neuromuscular Disease Registry (CNDR) was launched in 2010 to increase efficient patient access to cutting-edge research and clinical trials, to increase understanding of the natural history and epidemiology of neuromuscular disease across Canada, and to facilitate research collaboration. (2021-02-02)

Patients with lung cancer reduce smoking rate after enrollment in phase III clinical trial
The first comprehensive, prospective study of smoking habits in patients with non-small cell lung cancer (NSCLC) who were enrolled in a phase III early-stage trial revealed that there was a high rate of smoking reduction and cessation following study entry, according to research published today in the Journal of Thoracic Oncology. (2021-02-01)

Nivolumab effective treatment for malignant mesothelioma
Nivolumab monotherapy is an effective treatment option for relapsed malignant mesothelioma (MM), according to research presented today at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. (2021-01-30)

Two ADAURA analyses support use of Osimertinib for patients with surgically resected, Stage IB to IIIA non-small cell lung cancer
Two presentations from the ADAURA clinical trial advanced previous research that demonstrated improved disease-fee survival (DFS) outcomes for patients with surgically resected non-small cell lung cancer (NSCLC) receiving osimertinib. The data were reported today at the International Association for the Study of Lung Cancer's 2020 World Conference on Lung Cancer (WCLC) Singapore. (2021-01-29)

Reduced-dose RT with Cisplatin improves outcomes for HPV-associated oropharyngeal carcinoma
A combination of reduced-dose radiotherapy using intensity-modulated radiotherapy (IMRT) combined with concurrent cisplatin met the threshold for disease control and quality of life compared to the standard of care for good-risk patients with HPV-associated oropharyngeal squamous cell carcinoma on the NRG Oncology clinical trial NRG-HN002. (2021-01-29)

Heparin targets coronavirus spike protein, research shows
An international team of researchers has found that the common anticoagulant drug heparin inhibits the SARS-Cov2 virus spike protein, by reducing the virus' ability to attach to human cells and infect them. (2021-01-28)

Sotorasib provides durable clinical benefit for patients with NSCLC and KRAS mutations
In the phase II CodeBreak 100 trial, sotorasib provided durable clinical benefit with a favorable safety profile in patients with pretreated non-small cell lung cancer (NSCLC) and who harbor KRAS p.G12C mutations, validating CodeBreak 100's phase I results, according to research presented today at the International Association for the Study of Lung Cancer World Conference on Lung Cancer. (2021-01-28)

Trying to beat a coke habit with cannabis? Not so fast !
Taking cannabidiol, a chemical in the cannabis sativa plant, isn't an effective way to reduce your dependence on cocaine, researchers at the CHUM Research Centre find. (2021-01-27)

Lung-MAP translational discoveries shared at 2020 World Conference on Lung Cancer
Investigators leading the Lung Cancer Master Protocol, or Lung-MAP trial, will present findings from three translational medicine studies at the 2020 World Conference on Lung Cancer, to be held online January 28-31, 2021. (2021-01-27)

In preclinical models, antiviral better inhibits COVID-19 than Remdesivir; further studies warranted
Working in preclinical models, researchers report that plitidepsin, a drug with limited clinical approval for the treatment of multiple myeloma, is more potent against SARS-CoV-2 than remdesivir, an antiviral that received FDA emergency use authorization for the treatment of COVID-19 in 2020. (2021-01-25)

New maintenance treatment for acute myeloid leukemia prolongs the lives of patients
Patients with acute myeloid leukemia (AML), the most common form of acute leukemia in adults, that has gone into remission following initial chemotherapy remain in remission longer and have improved overall survival when they are given a pill form of the cancer drug azacitidine as a maintenance treatment, according to a randomized, international phase 3 clinical trial for which Weill Cornell Medicine and NewYork-Presbyterian are trial sites. (2021-01-22)

Pre-surgery chemotherapy is possible for early stage pancreatic cancer patients
A first-of-its-kind randomized clinical trial found that patients with pancreatic cancer didn't live any longer than expected after receiving pre-operative chemotherapy from either of the two standard regimens, according to trial results published in JAMA Oncology. (2021-01-21)

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