Articles tagged with Clinical Trials
Aerobic exercise has been shown to lessen several hemodialysis-related symptoms, including restless leg syndrome, symptoms of depression, muscle cramping, and fatigue. However, more research is needed to determine the extent of benefits from aerobic exercise for individuals with kidney failure who are undergoing dialysis.
A study by Jiarui Li and colleagues investigated representation of Black Americans in clinical trials for cardiovascular drugs approved by the FDA between 2006 and 2020. The researchers found that Black Americans were underrepresented in these trials, highlighting a need for increased diversity in clinical research.
Researchers found conservatives less willing to participate in medical research due to lower trust in science and ideological differences. The divide could threaten the generalizability of studies, impacting the quality and relevance of medical findings.
A new review identifies key personality traits associated with positive and negative psychedelic experiences, suggesting that individuals open to new experiences and willing to surrender may benefit from the therapy. Researchers propose using lower doses as a starting point for hesitant patients, building up to higher doses later.
The AstraZeneca vaccine demonstrated high vaccine efficacy of 78.9% against symptomatic COVID-19 disease, including severe disease or hospitalization. The vaccine also showed no increased risk of thrombotic events or cerebral venous sinus thrombosis among vaccinated participants.
Researchers at Vall d'Hebron Institute of Oncology are conducting a first-in-human Phase I trial to evaluate the safety and efficacy of Peptomyc's novel Myc inhibitor Omomyc in treating advanced solid tumors. The trial aims to confirm the compound's therapeutic potential, particularly for patients with progressed disease.
A recent SWOG Cancer Research Network study found that even with access to clinical trials, cancer patients living in the poorest neighborhoods have a nearly 30% greater chance of dying from their disease. The disparity persists despite uniform high-quality care.
A landmark South African study validates the need for second-generation Covid-19 vaccines, as the AstraZeneca vaccine showed minimal protection against mild to moderate infections caused by the B.1.351 variant. Despite this, the WHO recommends continued deployment of the vaccine in countries where the variant circulates.
A recent study published in Annals of Surgery found that antibiotic-only treatment for acute uncomplicated appendicitis resulted in high recurrence rates and inferior quality of life. In contrast, surgical intervention delivered better outcomes, including a significantly improved quality of life score.
A randomized clinical trial found that wearing clear masks reveals surgeons' faces, improving patients' perceptions of communication, trust, and empathy. This study suggests a potential benefit to using clear masks in surgical clinics.
A large-scale randomized trial involving nearly 24,000 women found no significant differences in health outcomes between two gestational diabetes screening methods. The study evaluated rates of gestational diabetes diagnosis, large-for-gestational-age infants, and adverse perinatal outcomes.
The CCE-DART project aims to develop interconnected tools to reduce the complexity of investigator-initiated trials, incorporating cutting-edge digital technologies. It will harmonize molecular multi-tier profiling platforms to precisely match patients to novel anti-cancer medicines based on genetic tumor specificities.
The Medical University of South Carolina has enrolled children with multisystem inflammatory syndrome in children (MIS-C) in a trial of remestemcel-L, a novel cellular therapy. The treatment showed significant improvement within 24 hours for two patients, offering hope for better management of the rare but life-threatening condition.
The BrainHealth Project trial unveiled a novel online platform delivering science-backed approach to measuring, improving, and tracking brain fitness. Participants showed significant improvements in their BrainHealth Index scores, with positive changes observed across various domains of brain health.
The FDA has qualified the DIBSS-C, a patient-reported outcome measure, to assess symptom-based efficacy endpoints in IBS-C clinical trials. This qualification reflects FDA's commitment to patient-focused drug development and is a major milestone for the IBS Working Group.
A comprehensive review of lung cancer screening trials reveals both benefits and harms, leading to updated USPSTF recommendations. Screening can lower lung cancer deaths in high-risk individuals, but also leads to false positives and unnecessary procedures.
A year-long clinical trial by University of Washington School of Medicine found hydroxychloroquine ineffective against COVID-19 progression to pneumonia or hospitalization. Researchers were able to efficiently enroll participants remotely and obtain vital signs through self-submitted data.
A new study found that global clinical trials enrolled less than half the proportion of Black patients as U.S. trials, highlighting a trend that may exacerbate racial disparities in cancer research and care. The study suggests that globalization of cancer clinical trials may be a key driver of these disparities.
Researchers at the University of Leicester are developing a new approach using virtual clinical trials to predict patient responses and optimize therapy efficacy for lung diseases. This innovative approach has the potential to reduce costs and speed up the development process by identifying which drugs are most likely to succeed.
A Vanderbilt University Medical Center survey identified strong collaborative relationships as a key factor in retaining clinical research coordinators. The study also found that compensation, career growth opportunities, and collegial relationships through hands-on involvement in clinical trials were significant predictors of retention.
A study found that less than one-third of COVID-19 clinical trials are led by women, a disparity compared to non-COVID-19 trials. The research suggests that gender biases and imbalances may expose systemic inequalities in women's access to research activities and funding.
Clinical trial registrations for COVID-19 interventions with high publicized attention were compared to those without comparable promotion. The study found that highly publicized treatments had significantly lower registration rates and higher completion rates, leading to concerns about bias in research.
A randomized clinical trial found that ivermectin did not improve the time to resolution of symptoms in adults with mild COVID-19. The study suggests that ivermectin may have no effect on treating mild cases of the disease, highlighting the need for further research.
A randomized clinical trial found that American Indian and Alaska Native adults with alcohol dependence responded positively to incentives for abstinence. The study examined the effectiveness of incentives offered for laboratory-confirmed abstinence from alcohol among participants diagnosed with alcohol dependence.
A large-scale trial found that daily albumin infusions provide no significant health benefit to patients hospitalised with advanced liver disease, over and above 'standard care'. The study showed no reduction in infection, kidney dysfunction, or death among patients receiving targeted albumin treatment.
A large-scale peer-reviewed study by the Clalit Research Institute found that the Pfizer vaccine reduces the risk of symptomatic COVID-19 by 94% and severe disease by 92% in fully vaccinated individuals. The study also showed substantial vaccine effectiveness even before completing two doses.
Researchers from Ruhr-University Bochum found that computerised training can reduce PTSD symptoms by helping patients reappraise trauma memories. Patients who underwent the 'Cognitive Bias Modification-Appraisal' training showed fewer trauma-relevant symptoms and lower stress hormone levels compared to those in a control group.
Researchers from Murdoch Children's Research Institute found a significant decrease in peanut allergy among infants after international infant feeding guidelines changed in 2016. The study also showed a rise in parents introducing peanut into their babies' diet since the guideline changes.
A trial in Mumbai found that regular clinical breast examination led to earlier diagnosis and reduced deaths from breast cancer, especially among women aged 50 and older. The study suggests that implementation of population screening by trained health workers is feasible in low and middle income countries.
A randomized clinical trial examines the effectiveness of subcutaneous semaglutide as an adjunct to intensive behavioral therapy for weight management. Semaglutide was found to lead to greater weight loss and improved body mass index compared to placebo in adults with overweight or obesity.
A randomized clinical trial found that a layperson-delivered empathy-focused program of telephone calls significantly reduced loneliness, depression, and anxiety compared to the control group. The study showed improved general mental health within four weeks.
Two monoclonal antibodies targeting the MERS coronavirus spike protein showed promise in a phase 1 clinical trial, being well-tolerated and safe when administered to healthy adults. The study found the experimental antibodies reduced virus levels and tissue damage in lungs.
Researchers found that CD14+ macrophages and neutrophils change rapidly in the brain after hemorrhage, with signatures consistent in patients with good recovery. Inhibiting inflammation may improve patient outcomes, and targeting specific molecular circuits could unlock new treatment options for ICH.
Researchers examined U.S.-based vaccine clinical trials from 2011 to 2020, finding they were underrepresented by racial/ethnic minorities, females, and older adults. The study aimed to address these disparities and improve vaccine inclusion.
A 3-month gap between doses significantly increases vaccine efficacy, with a single dose providing 76% protection. This extended interval supports current vaccination policies and is consistent with WHO's new advice.
A new report highlights disparities in vaccine clinical trials, showing that certain racial/ethnic groups and older people are not adequately represented. The study emphasizes the need for increased diversity and inclusion to ensure equitable representation of all populations, particularly those disproportionately affected by COVID-19.
The new guidelines recommend broadening eligibility criteria and requiring diversity study plans to increase African American participation. Gathering clinical trial data post-approval can also identify differences in safety and efficacy among racial subpopulations.
Researchers at University of California - San Diego will investigate psilocybin's safety and efficacy in treating chronic phantom limb pain. The study aims to elucidate brain mechanisms involved, including possible alterations in brain circuitry.
A new analysis published in The Lancet Psychiatry found that current psychological therapies for treating anorexia nervosa do not significantly differ from expert treatment as usual. This highlights the need for further research into more targeted therapies to improve patient outcomes.
A virtual reality app called Easyheights has been shown to improve ability to handle real height situations, with participants able to ascend further towards the top than before training. The app uses 360° images and gradually increases perceived distance without increasing fear levels.
The Human Genome Project has enabled millions to access their personal genomic information, but diversity gaps persist in clinical trials. Experts call for increased Indigenous participation, open data sharing, and multidisciplinary approaches to address biases and develop polygenic risk scores for diverse communities.
Pharmacologist Namandje Bumpus outlines a four-part plan to improve the equity of drug development, emphasizing the need for increased diversity in clinical trials. The plan includes implementing diversity requirements for funding agencies and research institutions, as well as genetic engineering of animal models to reflect ethnic vari...
A $5 million grant will support studies on scalable, low-cost, and noninvasive approaches to identify Alzheimer's disease. The project aims to improve the quality of life for patients and families by providing validated tools for early detection.
A two-dose regimen of the adenovirus-based vaccine offers high efficacy against symptomatic COVID-19, with no serious adverse events reported. The vaccine is well-tolerated across different age groups, including older adults.
The Canadian Neuromuscular Disease Registry has facilitated over 125 research projects and secured funding for patients across Canada. With data from over 4,000 patients, the registry provides valuable insights into neuromuscular disease outcomes and care.
Patients with non-small cell lung cancer who enrolled in a phase III early-stage trial showed a high rate of smoking reduction and cessation following study entry. Smoking rates were significantly lower among never-smokers, leading to improved overall survival compared to smokers.
A recent study published in Nature Communications found that the Radar COVID app can detect close contacts of infected individuals twice as accurately as manual tracing systems. The trial on La Gomera island detected an average of 6.3 close contacts per infected individual, compared to 3.5 using only manual tracing.
A nationwide lung cancer LDCT screening study found the effectiveness of low-dose computed tomography (LDCT) screening in a pre-defined, never-smoker population. The study revealed that family history significantly increased lung cancer risk, and most participants had stage 0 or 1 disease.
Researchers presented two radiation oncology trials that aimed to improve local tumor control in NSCLC patients. One trial found no significant difference in 2-year local-regional tumor progression-free rates between adaptive and standard radiation therapy arms, while another study demonstrated excellent local control rates with dose e...
A combination of reduced-dose radiotherapy using IMRT combined with concurrent cisplatin met the threshold for disease control and quality of life in good-risk patients with HPV-associated oropharyngeal squamous cell carcinoma. This approach yields improved outcomes compared to standard treatment, with lower rates of acute toxicities.
The NRG Oncology trial shows improved in-field tumor control with adaptive radiotherapy, increasing local-regional tumor control by 11% and primary tumor control by 17%. The study's results suggest individualizing radiotherapy dose prescriptions according to patient's intrinsic sensitivity for better survival outcomes.
In the phase II CodeBreak 100 trial, sotorasib demonstrated a confirmed response rate of 32.2%, a median duration of response of 10.9 months, and a median progression-free survival of 6.3 months in patients with pretreated NSCLC and KRAS p.G12C mutations.
Researchers evaluated the initiation of oncology clinical trials during COVID-19 pandemic to assess its impact on research and development. The study found that many trials were accelerated or started earlier due to increased emphasis on remote patient monitoring.
A new 90-day dual-purpose vaginal ring containing dapivirine and levonorgestrel has shown promising results in preventing both HIV and unintended pregnancy. The study found that the ring delivered sustained levels of each drug, likely sufficient for protection against both, with minimal bleeding concerns.
Close adherence to low-dose aspirin therapy resulted in 8 more pregnancies, 6 fewer pregnancy losses, and 15 more live births per 100 women. Starting aspirin before or early pregnancy showed stronger benefits than starting after the 6th week.
A new study published in Clinical Trials proposes staging cluster randomized trials to clarify uncertainties around school reopening policies. The trial design would create a rigorous evidence base for policymakers to make informed decisions, considering factors such as community transmission and health system capacity.
Researchers have developed a comprehensive framework to classify small-cell lung cancer into four unique subtypes based on gene expression. The study identifies potential therapeutic targets for each type, including an inflamed group that tends to be more responsive to immunotherapy.
A small pilot study suggests that early administration of ivermectin can reduce viral loads and symptom duration in patients with mild COVID-19. The treatment also showed a reduced duration of certain symptoms, including loss of smell and taste.
The NRG Oncology phase II clinical trial determined that the combination of total neoadjuvant therapy with pembrolizumab and chemoradiotherapy is safe for patients with locally-advanced rectal cancer (LARC). However, it may not offer any statistically significant improvement in downstaging of the cancer at the time of surgery.
A Phase 2 clinical trial has demonstrated the efficacy of cabozantinib in reducing tumor volume and pain in patients with neurofibromatosis type 1. The treatment showed a partial response in 42% of patients, with significant reductions in tumor pain intensity.