Articles tagged with Clinical Trials
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Women with small, low-grade tumors and a genetic profile at low risk of metastasis have only a 1.4% chance of locoregional recurrence within five years. Breast conservation surgery is as effective as mastectomy in reducing the risk of recurrence.
Researchers at the University of Maryland School of Medicine are conducting trials to test the safety and efficacy of an H7N9 influenza vaccine. The vaccine, developed by Sanofi Pasteur, will be evaluated in healthy volunteers and elderly adults, with different dosages and adjuvant combinations tested.
A new analysis has found that the PIVOT study's patient population was not representative of real-world patients, with those in the trial being older and sicker. This raises significant questions about the validity of the study's findings and potential treatment recommendations.
A clinical trial found that HRD-positive triple negative breast cancer patients respond well to standard AC chemotherapy, with better disease-free survival rates. The study used preserved tissue samples from nearly two decades ago and demonstrated the value of banking tissue for future research.
A new study casts doubt on the use of ketamine nasal sprays for treating severe depression. The pilot trial found that the dosage of ketamine through an intranasal device can vary greatly between individuals and within a day, leading to unpredictable side effects such as high blood pressure and psychotic-like symptoms.
Two new clinical trials are enrolling volunteers to test an experimental H7N9 influenza vaccine candidate in the US. The Phase 2 studies will evaluate different dosages and vaccination schedules of the inactivated vaccine, as well as an adjuvant to boost immune responses.
A Delphi Panel established 17 core outcomes for multimorbidity research, including health-related quality of life, mental health outcomes, and mortality. Researchers suggest considering a full range of outcomes based on study aims and interventions.
The MOMENTUM 3 clinical trial found that advanced heart-failure patients who received a centrifugal-flow circulatory pump had significantly lower rates of pump-related blood clots and stroke compared to those receiving an axial flow pump. Patients who received the centrifugal-flow pump also had fewer re-operations due to device malfunc...
Patients with advanced heart failure who received a novel heart pump experienced no malfunctions requiring replacement, and their risk of stroke was halved compared to those who received the established version. The new device uses fully magnetic levitation technology to push blood through the device and into the aorta.
A study found that 16.2% of dual-registered clinical trials had discrepant completion statuses, with 33.9% listed as 'completed' on ClinicalTrials.gov despite being 'ongoing' on EUCTR. This discrepancy may affect publication bias and systematic reviews.
A recent trial found that a one-off PSA test does not save lives in asymptomatic men, highlighting the need for more accurate ways to diagnose aggressive prostate cancers. The study of over 400,000 men aged 50-69 showed no significant difference in mortality rates between those who were screened and those who were not.
A single PSA test increased detection of low-risk prostate cancer, but made no significant difference in prostate cancer deaths after 10 years. This study suggests that current policy against prostate cancer screening may be justified, as potential benefits are outweighed by harms from overdetection and overtreatment.
Research at the TAT International Congress 2018 found that patients participate in phase 1 clinical trials for access to innovative cancer treatments, including targeted therapies and immunotherapy. The studies suggest that this increased participation is driven by a growing awareness of treatment options beyond traditional chemotherapy.
The Alzheimer Prevention Trials Webstudy allows people 50+ to monitor cognitive health and join clinical trials aimed at preventing dementia. The free online platform addresses the major obstacle of delayed enrollment in Alzheimer's treatments.
The National Institute of Allergy and Infectious Diseases is supporting clinical trials testing monoclonal antibodies as preventive therapies for antibiotic-resistant infections. The trials aim to prevent pneumonia caused by Pseudomonas aeruginosa and Staphylococcus aureus, two bacteria posing a significant threat to human health.
A new study published in Mayo Clinic Proceedings found that up to 37 percent of studies on clinical trials show grossly exaggerated early results. The researchers emphasized the need for physicians and patients to be cautious when considering new or early trial evidence, as it may not accurately reflect real-world outcomes.
A new e-Health platform has been developed to support healthy aging and prevent cardiovascular disease and dementia in the elderly. The HATICE trial involves over 2,500 participants aged 65 or older and aims to reduce risk factors through lifestyle changes and interactive guidance.
A Phase 2 clinical trial in South Africa found that revaccination with the Bacille Calmette-Guerin (BCG) vaccine significantly reduced sustained TB infections in adolescents. An experimental subunit vaccine candidate, H4:IC31, also showed promise in preventing TB infection or disease.
A new systematic review of eleven clinical trials involving nearly 500 participants found that cupping therapy has a high risk of bias and inconsistent results. The authors concluded that no conclusive recommendations for or against the use of cupping in sports performance can be made until further trials are carried out.
Researchers have successfully transplanted human lung stem cells into damaged lungs, regenerating bronchial and alveolar structures. The study shows promising results in treating chronic pulmonary diseases such as bronchiectasis.
A recent study found that nearly half of all prostate cancer randomized clinical trials use lab results that disproportionately exclude black patients. The study, published in JAMA Oncology, highlights the need for researchers to adjust entry criteria to prevent racial biases.
Researchers recommend changes to international guidelines to collect more patient-reported outcomes, improving understanding of treatment impacts on patients' health and quality of life. The updated guidance aims to facilitate high-quality data analysis and reporting, ultimately enhancing patient-centered care.
A randomized trial found that induced labor at 39 weeks significantly reduced cesarean birth rates compared to expectant management. Healthy, first-time mothers who underwent elective induction had lower rates of preeclampsia and respiratory support for their newborns.
A recent study found that changes between interim and final publications of randomized trials can be significant, affecting clinicians' and the public's understanding of treatment benefits. The study analyzed 613 interim publications and compared them with their final versions.
Researchers at Westmead Institute for Medical Research are conducting a new clinical trial using water to treat polycystic kidney disease. The PREVENT-ADPKD trial aims to investigate whether drinking the right amount of water can prevent adult polycystic kidney disease (ADPKD) from progressing to kidney failure.
The COMPASS trial found that the ADAPT technique is at least as good as stent retrievers for treating large-vessel occlusions, with 52% of patients achieving functional independence. Aspiration also showed a non-significant trend in favor of reperfusion success.
A two-year FINGER trial found that enhanced lifestyle counselling prevented cognitive decline despite the presence of the APOE4 gene. The intervention model is now being adapted and tested globally for global dementia prevention strategies.
Yale Cancer Center investigators developed a new statistical model to assess patient risk for cancer, which can result in more efficient and effective clinical trials. This approach can guarantee that the statistical power of the study is adequate to demonstrate if a new treatment is effective.
A new study found that direct aspiration first pass (ADAPT) approach is clinically equivalent to stent retriever first-line (SRFL) approach for treating large vessel occlusion strokes. Patients treated with ADAPT achieved functional independence at 90 days similar to those treated with SRFL.
Researchers developed a one-step process to enable peak BCI performance within three minutes, allowing users to control computer cursors just by imagining movement. The new approach streamlines calibration and reduces expert intervention, bringing the system closer to clinical availability.
A new report by Dr. Nav Persaud at St. Michael's Hospital suggests that the widely prescribed nausea medication Diclectin may not be effective in reducing symptoms for pregnant women. The report reanalyzes previously unpublished clinical trial data, which found a small symptom reduction of 0.7 points on a 13-point scale.
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.