Articles tagged with Clinical Trials
A 24-month clinical trial found that regular e-cigarette use does not have negative health effects on smokers. The study showed reduced nicotine withdrawal symptoms, lower exposure to cigarette smoke constituents, and no increase in body weight.
A recent review of US Food and Drug Administration registration data reveals that the proportion of women participating in clinical trials gradually increases from phase 1 to phase 2/3 trials. The analysis of 38 drugs with over 185,000 trial participants shows no systemic significant under-representation of women.
Researchers found that short-term treatment interruptions do not lead to permanent expansion of the HIV reservoir or irreversible immune damage. Upon resuming ART, participants' immune systems returned to normal levels.
A clinical trial investigates whether dietary and exercise interventions can decrease AGEs, which have been linked to cancer, in prostate cancer survivors. Preliminary data suggest that AGEs may be a better biomarker for lifestyle changes than previously used markers.
An investigation by The BMJ found that researchers misrepresented the results of animal studies to gain funding and approval for human trials. Experts call for urgent action to tackle poor practice and make animal research more transparent and reliable.
The ingestible capsule detects and measures gut gases, revealing a potentially new immune system and mechanisms in the human body that have never been seen before. The technology offers a game-changer for gastrointestinal disorders and could lead to fewer invasive procedures like colonoscopies.
A recent study published in the Journal of the American Medical Association calls for improved care for sepsis survivors, focusing on strategies to minimize physical disability and cognitive impairment. The recommended approach includes high-quality early sepsis care, post-discharge assessment and treatment, and screening for pre-exist...
Researchers at Boston University School of Medicine discovered a possible biomarker for Huntington's disease, which may help evaluate treatment effectiveness and potentially delay disease onset. The study found altered levels of microRNAs in individuals carrying the HD gene mutation twenty years before symptoms appear.
A meta-analysis of 33 clinical trials found no association between calcium and vitamin D supplements and a lower risk of fractures in older adults. The study included over 51,000 community-dwelling adults aged 50+, but the results do not support routine use of these supplements for fracture prevention.
A cervical pessary significantly reduced the risk of spontaneous preterm birth at less than 34 weeks. Pregnant women with a short cervix who used the device had a lower rate of preterm birth compared to those without the device.
The compound anle138b was shown to close harmful openings in the membrane of nerve cells and induce conformational changes that modify pore conductivity. Treatment with anle138b normalized brain activity and improved learning ability in mice affected by Alzheimer's disease, regardless of when treatment started.
A new nationwide clinical trial aims to make managing type 1 diabetes easier for patients using the world's first hybrid closed-loop system automated insulin delivery device. The trial, funded by Medtronic, will monitor blood glucose levels and adjust insulin doses continuously to help patients maintain stable blood sugar levels.
Research reveals significant gaps in participation among older adults with blood cancers, underscoring the need to close the gap and increase enrollment. Most patients under 65 are over-represented, while those aged 75+ account for only 4% of trials despite being diagnosed at a higher rate.
The National Institutes of Health is awarding up to $70 million to launch the Alzheimer's Clinical Trials Consortium, a network of 35 trial sites aiming to find new treatments for Alzheimer's disease. The consortium will improve recruitment strategies and infrastructure to accelerate clinical trials.
A new consortium aims to accelerate clinical trials and find new treatments for Alzheimer's disease by implementing efficient participant recruitment methods. The collaboration will provide centralized services, enabling researchers to run innovative clinical trials, manage data, and recruit participants from diverse backgrounds.
The Kymriah treatment demonstrated long-lasting remissions in non-Hodgkin's lymphoma (NHL) patients, with significant durability in responses seen across multiple trials. Durable remission rates were observed among 43% of DLBCL patients in the single-site pilot study and 73% at six months in the global trial.
The Phase 1/2 clinical trial showed that SPK-9001 reduced annualized bleeding rate by 97% and factor IX concentrate use by 99% in participants with hemophilia B. The data suggest a one-time infusion of SPK-9001 may sustain factor IX activity levels, reducing bleeding episodes.
Experts argue that regulatory failings led to new devices being marketed with inadequate evidence, resulting in serious complications for over 100,000 women worldwide. The authors recommend improving the evaluation of implantable devices through longer-term studies and patient registries.
A new gene therapy has successfully produced sustained levels of clotting factor in adult hemophilia B patients, eliminating the need for regular infusions. The treatment, which uses a highly active variant of the clotting factor, achieved significant clinical benefits with no adverse effects.
Fetal monitoring specialists argue that continuous electronic monitoring is associated with lower infant mortality and should be used for all women in labor. However, other experts claim that the practice increases intervention rates and may not prevent neonatal deaths, suggesting a reevaluation of its benefits.
A new Army-developed Zika vaccine has induced a robust immune response in healthy adults, with over 90% of volunteers developing an immune response against the virus. The vaccine, developed by Walter Reed Army Institute of Research, was tested in three phase 1 studies and showed promising results.
A new Zika vaccine has demonstrated well-tolerability and induced potentially protective immune responses in three phase 1 clinical trials. The vaccine, called ZPIV, was developed by the Walter Reed Army Institute of Research and is being evaluated in several trials to determine its safety and efficacy.
A gene-based Zika vaccine developed by NIH scientists has been found to be safe and immunogenic in healthy adults, with 60-89% of participants generating a neutralizing antibody response. The vaccine, which includes a small piece of DNA called a plasmid, triggers the body to mount an immune response when injected into muscle.
A new Zika vaccine candidate has produced strong immune responses in healthy adults, with nearly all recipients mounting protective antibody responses against the virus. The vaccine was safe and caused only mild reactions, offering a promising step towards an effective Zika vaccine.
Researchers have developed an inactivated Zika purified virus (ZPIV) vaccine that induced an immune response in participants and was well-tolerated, according to Phase 1 clinical trial results.
A Cancer Research UK-funded study found that combining anti-CD27 and anti-CD20 antibodies increases life expectancy in mice with cancer by nearly doubling the median survival time. The combination recruits more immune cells and enhances their ability to destroy cancer cells, offering a promising new approach to treating lymphoma.
Research analyzed 43 trials involving 8,406 women and found that vitamin D supplementation increased birth weight and reduced small baby risk, but results were inconsistent and limited by study quality. Further large-scale trials are needed to determine the effectiveness of prenatal vitamin D supplementation.
Leading lung cancer specialists call for immediate action to implement life-saving lung cancer screening programmes across Europe. The EU Position Statement on Lung Cancer Screening provides a detailed set of recommendations and a 'Call to Action' for policymakers to start planning within the next 18 months.
The SWOG and Hope Foundation's VA Integration Support Program provides $25,000 grants to VA medical centers to enroll veterans in targeted treatments and immunotherapies. Since program launch, 95 patients have enrolled in clinical trials, a 300% increase prior to the program.
PAC-1, a cancer drug that targets procaspase-3, has been approved for use in a phase Ib trial of patients with anaplastic astrocytoma and glioblastoma multiforme. The drug has shown promise in pet dogs with brain cancers and is being tested in combination with temozolomide.
A new study used MRI imaging technology to plot diverse changes in body organ fat storage pools during 18 months of Mediterranean/low-carb and low-fat diets, with and without moderate physical exercise. The results showed that even with modest weight loss, the Med/LC diet was significantly superior to a low-fat diet in reducing some fa...
A UK study found that less than one per cent of children born with congenital heart disease participate in clinical trials, highlighting a need for improved treatment options. Researchers suggest establishing a congenital heart disease research network to conduct well-designed clinical trials and improve surgical outcomes.
Experts recommend restrictive blood transfusion practices for stable patients with hemoglobin levels of 7 g/dL or higher, reducing mortality and blood clot risks. The study found significant reductions in blood use by 40-65% in largest randomized trials.
Researchers launch PLAT-05 trial to develop a more robust defense against cancer cells, aiming to cut the rate of relapse by almost half. The new therapy will target both CD19 and CD22 proteins on cancer cells, providing long-term remission for patients.
Researchers have discovered a potential treatment for amyotrophic lateral sclerosis (ALS) using the medication pimozide, which was found to stabilize progression and alleviate symptoms in animal models. A limited clinical trial on human subjects suggests that pimozide may be effective in improving patients' quality of life.
A phase 1 clinical trial has opened enrollment for children aged 12 and above, leveraging a re-engineered polio virus to treat high-grade brain tumors. Dramatic responses have been seen in adult trial participants, paving the way for this innovative therapy to be tested in pediatric patients.
A preclinical study demonstrates the effectiveness of PRO 140, a humanized anti-CCR5 monoclonal antibody, in preventing graft-versus-host disease (GvHD) in bone marrow stem cell transplantation. The study shows that PRO 140 successfully blocked GvHD development without affecting hematopoietic cell engraftment.
A study of 1,000 patients with chest pain found that adding noninvasive cardiac testing did not improve clinical outcomes, but rather prolonged hospital stays and increased costs. The test also resulted in more radiation exposure and repeated emergency department visits without a significant reduction in major adverse cardiac events.
A randomised trial found that keyhole repair is more effective than traditional open surgery for repairing ruptured abdominal aortic aneurysms. The study showed lower mortality rates and reduced hospital stays in the keyhole group, leading to improved quality-adjusted life years.
Researchers developed and grew modified Cavendish bananas resistant to Fusarium wilt tropical race 4 (TR4), a devastating soil-borne fungus. One line remained TR4-free for three years, while three others showed strong resistance.
The DAWN trial demonstrated the efficacy of thrombectomy in reducing disability among stroke patients presenting within 6-24 hours, with a 48.6% independence rate at 90 days compared to 13.1%. Thrombectomy also showed benefits across various subgroups and time windows.
A recent study published in the New England Journal of Medicine found that clot removal up to 24 hours after stroke can significantly reduce disability for properly selected patients. Almost half of those who underwent thrombectomy showed considerable improvement in activities of daily living.
Researchers studied wild-born bonobos at a sanctuary in the Democratic Republic of Congo. The results showed that bonobos will help strangers get food even when there is no immediate payback. This behavior is linked to a basic form of empathy called emotional contagion, which suggests that bonobos are also contagious with yawning.
A new study found that treatment with tranexamic acid must be given within minutes of severe bleeding to improve survival by 70%. The World Health Organization has updated its recommendations for the use of tranexamic acid, calling for it to be made readily available in all health systems to reduce global deaths from severe bleeding.
A phase 4 randomized clinical trial found that self-administered treatment for latent tuberculosis infection had a high rate of treatment completion in the United States, Spain, and Hong Kong. The findings suggest that once-weekly isoniazid and rifapentine by self-administration is noninferior to direct observation in completing treatm...
A Phase 1 clinical trial has demonstrated encouraging data for gene replacement therapy in patients with spinal muscular atrophy type 1 (SMA1). The study found that high-dose gene therapy improved motor function and reduced the need for supportive care in patients treated with a single intravenous infusion.
The CULPRIT-SHOCK trial found that culprit lesion only percutaneous coronary intervention (PCI) reduces the composite of 30-day mortality and/or severe renal failure in patients with multivessel disease and cardiogenic shock. Immediate multivessel PCI was associated with higher rates of adverse outcomes.
Researchers found TAVR to be highly cost-effective compared to SAVR in intermediate surgical risk patients with aortic stenosis. Over two years, follow-up costs were substantially lower with TAVR than SAVR, resulting in lifetime cost savings and improved quality-adjusted life expectancy.
A new mapping reveals trends in G protein-coupled receptor-targeted drugs, indicating more precise effects and reduced side effects. The study also identifies potential for further research into untargeted receptors related to genetic and immune disorders.
The DKCRUSH-V trial found that the double kissing crush two-stent technique resulted in a lower rate of target lesion failure compared to provisional stenting at one year. The study also showed improved outcomes for patients with true distal left main bifurcation lesions.
A clinical trial involving 311 patients with prodromal Alzheimer's found significant advantages in nutrient-treated patients, including 45% less worsening in Clinical Dementia Rating-Sum of Box. The study also showed less brain atrophy in the active group, with notable benefits for hippocampal damage and everyday tasks.
Patients with left main coronary artery disease (LMCAD) who underwent percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) showed similar quality of life improvements at three years. PCI demonstrated a greater early benefit, with improved health status measures that were sustained over time.
A systematic review of 18 trials found that delayed clamping reduced hospital mortality by a third and increased neonatal hematocrit, confirming placental transfusion. Delayed clamping can save up to 100 additional lives per thousand very preterm babies born prematurely.
A new federally funded program aims to strengthen development of innovative pediatric medicines and devices by incorporating best practices and novel approaches. The Institute for Advanced Clinical Trials for Children will lead the initiative, which includes several other organizations committed to children's health.
A £1.1 million trial led by the University of Stirling will investigate whether a self-management programme can help women with pelvic organ prolapse manage their symptoms more effectively. The trial will compare standard care with self-management, focusing on women's quality of life and cost implications.
Researchers found that some γ-secretase inhibitors, like semagacestat, cause accumulation of toxic intraneuronal Aβ instead of inhibiting its production. This discovery sheds light on the discrepancy between preclinical and clinical trial findings for Alzheimer's disease treatments.
The US FDA has awarded a grant to I-ACT for Children to establish an alliance among leading institutions and health systems to address gaps in pediatric clinical trials. The network aims to improve the efficiency of trials through innovative design, operational efficiency, and stakeholder engagement.
Tufts Medical Center joins a new initiative to advance critical emergency medicine research with the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) Network. The SIREN Network will conduct large-scale clinical trials to test new treatments in cardiology and neurology.
Research examines the benefits of palliative care in heart failure treatment, showing improved patient-centered outcomes. Palliative care can address symptoms like pain and depression to enhance treatment effectiveness.
A recent study published in The BMJ found that first-time mothers with an epidural who adopt a lying down position during the second stage of labor are more likely to deliver their baby without any medical intervention. The study involved 3,093 women and found a 5.9% increase in the chance of spontaneous birth in the lying down group.