Research on the trials that test new treatments in patients. Covers trial design, respiratory and cancer trials, screening tools, and treatment breakthroughs.
Changing healthcare payment for one insurer can impact patients covered by others, a nationwide randomized trial suggests. The study found lower hospital readmissions and care intensity among TM patients and those with private insurance through Medicare Advantage.
The Predictive Safety Testing Consortium and Duchenne Regulatory Science Consortium have developed a glutamate dehydrogenase (GLDH) biomarker to detect drug-induced liver injury in patients with inherited muscle disorders. The FDA has agreed to accept the Qualification Plan for GLDH as an important and accurate measurement of DILI.
A clinical trial by Newcastle University found that levothyroxine does not improve cardiac function in patients who have had a heart attack and are suffering from mild or subclinical hypothyroidism. The treatment, which is commonly recommended for these patients, may actually be of no benefit.
A USC-led team found a fasting-mimicking diet combined with hormone therapy may increase the power of cancer hormone drugs and delay resistance in small clinical trials and mouse studies. Researchers observed reduced insulin, IGF1, and leptin levels, leading to potential anti-cancer activity.
The National Pediatric Rehabilitation Resource Center aims to promote clinical trials research in pediatric rehabilitation. The center will fund up to $150,000 per year for pilot studies and offer educational resources to support the growth of the field.
A Chinese phase 2 trial found that a recombinant adenovirus type-5-vectored COVID-19 vaccine is safe and induces an immune response in over 500 participants. The trial, which evaluated the safety and immunogenicity of the vaccine candidate, provides data on the efficacy of the vaccine against SARS-CoV-2 infection.
The phase 1/2 trial found the vaccine induces strong antibody and T cell immune responses, and causes minor side effects more frequently than a control group. Further clinical studies are needed to confirm the vaccine's effectiveness in protecting against SARS-CoV-2 infection.
A new randomized trial published in Annals of Internal Medicine found that hydroxychloroquine showed no benefit in reducing symptom severity or duration in outpatients with early, mild COVID-19. The study suggests that the treatment may not be effective in populations at higher risk for severe COVID-19.
A large international study found that starting dialysis early in critically ill patients with acute kidney injury did not reduce mortality after three months. The accelerated renal-replacement therapy strategy did not show significant difference in survival between the two treatment approaches.
A recent study by UNLV researchers found that while the success rate of Alzheimer's drugs in development remains low, there is increased hope due to repurposed agents and advancements in biomarkers. The team also emphasized the critical role of patient participation and the need for investment in new therapies.
A major multinational trial found that fast-tracking dialysis for critically ill patients with severe acute kidney injury did not improve outcomes. The study included over 3,000 patients in 168 hospitals across 15 countries and suggested a more conservative approach to treatment may be warranted.
Researchers at UC San Diego highlight nanotechnology's role in COVID-19 vaccine development, including peptide-based vaccines and molecular farming. The first candidates in clinical trials utilize novel nanotechnologies.
The Phase 1 trial of mRNA-1273 vaccine showed neutralizing antibody activity in healthy adults, with high levels observed after two doses. The vaccine was generally well-tolerated, with side effects including fatigue and pain at the injection site.
A 10-year study found that radiotherapy in five larger doses, rather than daily doses, is equally effective and safe in the long term. This approach benefits patients with low risk of relapse who cannot tolerate daily radiation due to frailty or chronic conditions.
The review analyzes the design and implementation of RCTs for COVID-19 treatments, identifying common characteristics and limitations. Key takeaways include the importance of standardized reporting and the need for further research on treatment outcomes.
The National Institutes of Health has established a new clinical trials network to enroll thousands of volunteers in large-scale clinical trials testing various COVID-19 vaccines and monoclonal antibodies. The COVPN will leverage existing infrastructure and engage communities to secure participants for late-stage clinical trials.
Tofersen, an experimental drug for a rare inherited form of amyotrophic lateral sclerosis (ALS), has shown early promise in a phase 1/phase 2 clinical trial. The study found that the drug is generally well-tolerated and lowers levels of a disease-causing protein in people with SOD1 ALS.
The UCSC-led research center aims to understand the basic biological mechanisms of botanical natural products and address challenges in studying their variability and clinical trial design. The center will use innovative screening platforms to measure the effects of complex botanical natural products on cells.
A clinical trial found that breast augmentation with ASC-enriched fat grafts resulted in significantly better outcomes compared to non-enriched grafts. The study showed improved retention rates and histological appearance of the grafts, making ASCs a promising tool for increasing graft success.
A randomized trial of a multifactorial fall injury prevention strategy found an approximately 8-10% reduction in serious fall injuries, lower than expected. The study enrolled 5,451 people aged 70 and older and evaluated the effectiveness of a nurse-delivered intervention.
A large randomized trial has found that endometrial scratch is not beneficial in women having their first cycle of IVF. The study involved over 1000 women under 37 years old and showed no significant difference in live birth rates between those who received endometrial scratch and those who did not.
A clinical trial is underway to test an immune booster, IMM-101, in cancer patients to prevent severe COVID-19. The study aims to boost the innate immune system and protect vulnerable populations from lung infections.
PRRT is an approved treatment modality for gastroenteropancreatic neuroendocrine tumours, particularly in midgut NETs. In Australia, PRRT is used more widely than previously thought, despite limited Phase III trial data for lung NETs.
Plant pathologists at Auburn University conducted a field trial to assess the economic damage of reniform nematodes on cotton yields. The study found that cotton yields were 50% lower in fields infested with the nematode compared to clean fields.
A pooled analysis of DEFINE FLAIR and iFR SWEDEHEART trials reveals similar safety profiles for iFR and FFR in deferring revascularisation. However, FFR-based deferral shows a strong interaction with age, which may be related to varying age-related responses to adenosine.
A meta-analysis of randomized trials found routine revascularization associated with lower non-procedural MI and unstable angina risk, but higher procedural MI rates. The benefits of routine revascularization compared to medical therapy are still uncertain.
The study found that colchicine treatment was associated with reduced levels of inflammatory biomarkers and improved clinical outcomes in patients hospitalized with COVID-19. Colchicine's effectiveness in managing cardiac-related complications was also observed, suggesting potential benefits for these patients.
A new international trial published in the Journal of Clinical Oncology suggests that carboplatin-paclitaxel is the optimal chemotherapy regimen for treating inoperable anal cancer. The study found a trend toward improved survival and less toxicity compared to cisplatin-5FU, with overall survival rates of 20 months vs 12.3 months.
The InterAAct trial found carboplatin-paclitaxel to be the optimal chemotherapy regimen for inoperable anal cancer, with a lower risk of adverse events and improved overall survival. Patients treated with this regimen experienced a trend towards better survival rates, suggesting it should become the standard of care.
The COVID-19 pandemic has significantly impacted the design and analysis of oncology trials, presenting challenges for cancer researchers and clinicians. As a result, cancer treatment options and patient care have been disrupted, highlighting the need for new strategies to overcome these obstacles.
Researchers are testing virtual care and remote monitoring technology to reduce unplanned hospitalizations and emergency department visits after surgery. Patients use tablet computers to record vital signs at home, which are sent instantly to nurses for review.
A major study published in Nature Communications reveals that normothermic machine perfusion assessment can recover enough livers from discarded donors to allow successful transplantation. This breakthrough technique has significant implications for the liver transplant waiting list and demand for transplants far outstrips supply.
A combination of physical activity, not smoking, light-to-moderate alcohol consumption, high-quality diet, and cognitive activities reduced the risk of Alzheimer's disease by 60% among those with four or five healthy behaviors. The study included data from nearly 3,000 participants from two NIH-funded longitudinal study populations.
Annals of Internal Medicine publishes new COVID-19 research, highlighting the importance of high-quality clinical trials and informative multi-group trials to counteract misleading information. The journal also emphasizes the potential for the pandemic to transform medical care, education, and work.
A study published in JAMA Neurology reports successful delivery of micro-dystrophin to patients with Duchenne muscular dystrophy (DMD), resulting in functional improvements. The therapy showed robust gene expression and localization, as well as improved muscle function measured by North Star Ambulatory Assessment scores.
A new nonsurgical treatment decreases errant blood flow in the shoulder to quickly reduce pain and improve function in patients with adhesive capsulitis, also known as 'frozen shoulder'. The treatment was successfully completed in 16 patients whose symptoms had not responded to conservative treatment over 30 days.
A randomized clinical trial investigated treating patients with relapsing multiple sclerosis using a therapeutic hookworm infection, comparing it to placebo. The study aimed to determine if gut worms could induce immune responses that protect against multiple sclerosis.
A randomised clinical trial has shown that a chemotherapy combination of carboplatin and paclitaxel is more effective and better tolerated than previously recommended treatments for patients with advanced anal cancer. The study found that these patients lived seven months longer overall, experiencing less treatment side effects.
Researchers from University of Washington and Fred Hutchinson Cancer Research Center propose using multigroup, adaptively randomized trials to compare multiple COVID-19 interventions. This design may reduce adverse outcomes during trials and enable faster implementation of effective treatments.
A review published in Neurology clarifies the different courses of multiple sclerosis (MS) and disease activity, aiming to improve patient care and clinical trial outcomes. The experts define four subtypes: clinically isolated syndrome, relapsing remitting MS, secondary progressive MS, and primary progressive MS.
Early human challenge trials of SARS-CoV-2 vaccines may be the correct test of ethics, meeting equitable distribution principles. An international governance system is proposed to oversee access to Covid-19 vaccines and treatments.
A recent study led by Washington State University's Carrie Cuttler found that cannabis reduces the severity of post-traumatic distress disorder (PTSD) symptoms by about 62% for intrusions, 51% for flashbacks, and 67% for irritability. However, the symptom reductions were not permanent.
A study analyzing 201 registered COVID-19 clinical trials found that many lacked key features such as control groups and blinding. The majority were also designed to enroll fewer than 100 patients, limiting their usefulness. This has raised concerns about the quality of evidence for potential treatments.
A new study by Bocconi University researchers finds that the majority of phase III trial results are not significantly above threshold, contrary to previous findings. The researchers suggest that transparency and registration processes are key factors in maintaining trial integrity.
BIOCAD presents results of clinical trial showing netakimab decreases disease activity and reduces skin manifestation of psoriatic arthritis through 24 weeks of therapy. The treatment was well-tolerated, with significant improvement in skin manifestations and quality of life.
The SWOG Cancer Research Network is sparking discussion and creating consensus on how cancer clinical trial stakeholders can best interact on social platforms. The growing role of social media in raising awareness about trials and boosting accrual highlights both promises and challenges, including legal, ethical, and logistical hurdles.
The COVID-19 outbreak led to a significant decrease in national enrollment in cancer clinical trials, according to a new study. The research found that the pandemic disrupted clinical trials, resulting in a substantial drop in participation.
SYNB1891, an engineered E. coli Nissle strain producing cyclic di-AMP, demonstrates anti-tumor activity and generates immunological memory in preclinical models of cancer. The therapy is being evaluated in a Phase 1 clinical trial for patients with advanced solid tumors or lymphoma.
A Phase 2 clinical trial has shown a novel treatment protocol to be effective in patients with intravascular large B-cell lymphoma (IVLBCL), achieving two-year survival rates of up to 76% and overall survival rates of 92%. The treatment, combining conventional drugs with high-dose methotrexate and intrathecal chemotherapy, has been fou...
The NRG Oncology trial RTOG 1010 found that adding trastuzumab to neoadjuvant trimodality treatment did not improve disease-free survival for patients with HER2-positive local and locally advanced esophageal adenocarcinoma. The study also showed no significant differences in treatment-related toxicity between the two arms.
Researchers at University of Turku find glucocorticoids inhibit interferon signalling, leading to increased mortality rates. Glucocorticoids have been banned by WHO for COVID-19 treatment due to their harmful effects.
The NRG Oncology trial NSABP B-43 found a statistically non-significant, modest reduction in the rate of recurrence among women that received trastuzumab. The study showed an annual IBTR event rate of 0.80% per year in the RT+T group compared to 0.99% per year in the RT group.
A randomized phase 3 trial found no improvement in progression-free survival for carfilzomib compared to the standard treatment bortezomib. Carfilzomib was associated with higher very good partial response rates but more severe toxicities, including cardiac and renal issues.
A phase 3 trial found that surgery and radiation after initial systemic therapy did not improve overall survival for women with stage IV breast cancer. The study suggests that these treatments should not be routine practice, instead focusing on proven therapies to prolong life.
The Ivy Brain Tumor Center is conducting a Phase 0 clinical trial to evaluate the combination of two targeted therapy drugs, abemaciclib and LY3214996, in patients with recurrent glioblastoma. The study aims to confirm that these drugs can effectively cross the blood-brain barrier and block cancer cell growth.
The study found that women and racial minorities were significantly underrepresented in pivotal trials supporting approval of new cardiometabolic medicines. This underrepresentation may lead to variation in treatment outcomes and survival, emphasizing the need for increased diversity in clinical trial participants.
A randomized clinical trial found a workplace wellness program significantly improved employee health and reduced medical use. The program, which included health screenings, wellness activities, and financial incentives, showed sustained benefits after 12 and 24 months.
Investigating potential adverse effects and antibody-dependent enhancement is crucial for vaccine development. Comprehensive safety tests are necessary before widespread implementation.
A study by Johns Hopkins Medicine found that women and older adults are still vastly underrepresented in lipid lowering therapy trials, despite their high disease burden. The researchers analyzed 60 studies from 1990 to 2018 and reported a modest increase in representation of women, but many trials excluded pregnant or breastfeeding wo...
Researchers developed a framework using an epidemiological model of COVID-19 to calculate the optimal statistical threshold for approving a drug during a pandemic. This allows regulators to make a trade-off between false positives and false negatives, prioritizing the need for more timely approvals during outbreaks.