Articles tagged with Clinical Trials
The CTRI will support eight junior faculty through the CTSA grant program, create a new post-doctoral fellowship focused on team science, and develop infrastructure to speed regulatory processes. The institute will also expand biomarker and biocomputational capacity and improve information systems tools for research.
Researchers found that vitamin D supplements improved vitamin D levels and reduced falls in a five-month trial. The study suggests vitamin D may help maintain muscle integrity and strength, reducing the risk of falls in vulnerable populations.
Research found that prolonged hypoxemia during the first 2-3 months after birth was associated with an increased risk of disability or death at 18 months in extremely preterm infants. The study also revealed that intermittent bradycardia did not significantly add to the risk of adverse outcomes.
A 3-year testosterone supplementation study found no significant association between treatment and atherosclerosis progression. The trial also showed no improvements in sexual function or quality of life, despite increased hematocrit and prostate-specific antigen levels.
A three-year clinical trial found no link between testosterone administration and atherosclerosis progression, sexual function, or quality of life in older men. The study suggests that testosterone should not be used indiscriminately by men, as it may not provide benefits for these outcomes.
A new technique helps doctors optimize cancer treatment doses in phase I/II clinical trials. The Optimal Two-Cycle Dose-Finding Design uses a patient's cycle 1 data to set a dose level for the second cycle, improving patient benefit and controlling toxicity risk.
A preclinical randomized controlled trial was conducted to evaluate a potential stroke therapy that had shown promise in one mouse model but not another. The study found that the treatment's success may depend on the type and severity of the stroke, suggesting improved clinical trial design could have mitigated this issue.
Large-budget clinical trials evaluating drugs or dietary supplements for cardiovascular disease reported fewer positive outcomes after new transparent reporting standards were implemented around 2000. The study found that 57% of trials from 1970-1999 reported positive results, compared to only 8% of trials from 2000-2012.
A European clinical trial shows that therapeutic hypothermia can significantly decrease intracranial pressure in patients with severe traumatic brain injury. The study found a mean reduction of 4.3 mmHg at the first hour of body cooling, continuing throughout the 6-hour hypothermia therapy.
A new clinical trial found that tamsulosin improves the passage of larger kidney stones, with 83.3% of patients treated with the medication passing their stones compared to 61% on placebo. However, for small kidney stones, time remains the best cure, according to lead author Jeremy Furyk.
A small clinical trial suggests that a genetically-enhanced stem cell therapy can improve blood flow in the lungs and enhance exercise ability in patients with PAH. The therapy was generally well-tolerated, but one patient died after treatment due to severe disease progression.
A new treatment method using magnetic pulses has shown promise in reducing tinnitus symptoms for more than half of study participants. The treatment, known as transcranial magnetic stimulation, targets the auditory cortex in the brain and has been approved only for depression treatment.
A Phase I research study is underway to develop a vaccine that could prevent recurrence of some childhood cancers in patients who have relapsed after surgery, chemotherapy and radiation. The trial has enrolled three patients so far and aims to stimulate the immune system to attack specific tumor proteins.
Results from the EORTC trial 62072 show pazopanib improves progression-free survival in soft tissue sarcoma patients without affecting their health-related quality of life. The study provides valuable data on treatment outcomes and cost effectiveness for this patient population.
A new investigational vaccine designed to protect against West Nile Virus infection is being tested in a Phase 1 clinical trial. The vaccine was developed with a novel, hydrogen peroxide-based process that renders the virus inactive while maintaining key immune-system triggering surface structures.
A UK trial has shown significant benefits in lung function for patients with cystic fibrosis who received gene therapy. The treatment involves replacing the faulty gene responsible for the disease and was found to be safe and effective. Further research is needed to improve its effectiveness before it can be used as a clinical treatment.
A new treatment for children with neuroblastoma has shown promise in a phase I study, with minimal side effects and long-term survival of three patients. The drug DFMO targets an important cancer stem cell pathway to 'turn cells off,' potentially preventing relapse.
The article highlights lessons learned from monitoring complex HIV clinical trials in Africa over 15 years, including the use of on-site and central monitoring, local monitor teams, and standardized processes. The authors encourage global trial teams to publish their practical observations to improve best practices.
The BMJ has introduced a new policy requiring data sharing for all clinical trials, building on initial policies for drug and device trials. This move aims to promote transparency and reproducibility in research, as encouraged by initiatives from the US Institute of Medicine and World Health Organization.
A clinical trial confirms that pinaverium is an effective and safe option for treating irritable bowel syndrome (IBS), with a significantly higher percentage of patients reporting improved symptoms compared to the placebo group. The medication was also associated with common side effects, but no severe adverse effects were reported.
Researchers at UNC School of Medicine have developed an experimental gene transfer-based treatment to deliver a missing gene into the cerebrospinal fluid of children with GAN. The treatment approach uses a genetically modified virus to deliver the gigaxonin gene, which is expected to pave the way for treatments for other related diseases.
Researchers developed a calorie-restricted diet that mimics fasting to promote regeneration and extend lifespan in mice. A human pilot study found similar benefits, with decreased risk factors for aging-related diseases.
A new study by USC's Valter Longo suggests that a periodic diet mimicking fasting can cut visceral belly fat, boost neural regeneration and improve learning and memory in old mice. In humans, the pilot study found evidence of reduced risk factors for aging, diabetes, cardiovascular disease and cancer with no major adverse side effects.
A large study of over 5,000 extremely preterm infants found that those enrolled in randomized clinical trials had similar in-hospital outcomes to those who were not enrolled. The primary outcome of death, bronchopulmonary dysplasia, and severe brain injury did not differ significantly between groups.
A study comparing antibiotics vs. appendectomy found that antibiotic treatment was not more effective than surgery in treating uncomplicated appendicitis. However, most patients who received antibiotics did not require an appendectomy, and those who did did not experience significant complications.
Patients suffering from symptomatic vitreomacular adhesion experience improved vision after receiving ocriplasmin injections, without undergoing surgical treatment. The non-surgical approach avoids risks and costs associated with surgery, making it an attractive option for preventing blindness.
A new study combining data from two large trials suggests that one dose of the bivalent HPV vaccine may be sufficient to protect against most cervical cancer cases, with high efficacy seen in women receiving one, two, or three doses. The findings have significant implications for global health, particularly in resource-poor settings wh...
A recent study published in The Lancet Oncology suggests that a single dose of the HPV vaccine Cervarix can provide similar protection to three doses, offering hope for improving vaccination rates. This finding is particularly relevant for states like Kentucky with low completion rates.
Patients treated with rapid cooling before catheterization showed less heart muscle damage and a reduced incidence of heart failure. Therapeutic hypothermia was especially protective in patients with large areas of at-risk myocardium.
The TECOS study found that adding sitagliptin to usual care did not increase the risk of major adverse cardiovascular events or hospitalization for heart failure in patients with type 2 diabetes and established cardiovascular disease. Researchers also reported no significant link between sitagliptin and an increased risk of acute pancr...
Researchers have found that administering antibiotics for only four days is as effective as treatments spanning eight days for complicated abdominal infections. This breakthrough suggests that doctors can provide treatment that is both effective and conservative in its antibiotic use, reducing the risk of antibiotic resistance.
A five-year phase II clinical trial testing the ability of BCG to clinically improve type 1 diabetes in adults will be conducted at Massachusetts General Hospital. The trial aims to create a lasting therapeutic response and has received $19 million out of $25 million needed for the study.
A meta-analysis of existing data found that the Safe Surgery Checklist (SSCL) improves outcomes worldwide, reducing mortality by 21% in high-income countries and 35% in low-middle income countries. The checklist also significantly reduces surgical site infections and postoperative complications.
Ibn Sina's seven rules for testing drug potency via analogy and experiment are relevant to modern clinical trials. His seventh rule emphasizes the need for human-based experimentation to avoid differences between animal and human bodies.
A groundbreaking Alzheimer's disease prevention trial is supported by $10 million in new funding, focusing on therapies targeting amyloid proteins. The trial will test two investigational anti-amyloid therapies to prevent or delay Alzheimer's symptoms in people at high genetic risk.
A new plasma protocol effectively treats trauma patients quicker in ERs by delivering thawed plasma within 10 minutes of arrival. This approach improves outcomes for victims with massive bleeding and reduces wastage of frozen plasma.
The EU Clinical Trials Regulation aims to improve cancer research in Europe, but its implementation poses challenges for researchers and Member States. The regulation includes provisions such as a one-time-consent for patient data and tissue use, creating a single registration portal, and data transparency.
Researchers found that Polyphenon E, a green tea extract, reduced combined rates of prostate cancer and atypical small acinar proliferation, as well as decreased levels of prostate-specific antigen in men with premalignant lesions. The study suggests that EGCG, the most abundant catechin in green tea, may play a role in these effects.
A Phase I/II trial has shown promising results for a new stem-cell based therapy in children with recessed dystrophic epidermolysis bullosa (RDEB), a painful skin condition. The treatment involves infusions of mesenchymal stromal cells, which improved pain scores and reduced the severity of the disease.
A clinical trial has successfully implanted a neural prosthetic device in a region of the brain that controls intentions, allowing a paralyzed person to control a robotic arm with their thoughts. This new approach produces more natural and fluid motions compared to current neuroprosthetics.
Caltech researchers successfully implanted a device in a patient with quadriplegia, allowing him to control a robotic arm with his thoughts. The new approach records signals from the posterior parietal cortex, improving motor control and making movements more natural.
In a small clinical trial, researchers safely used immune cells grown from patients' own bone marrow to treat multiple myeloma. Thirteen of 22 patients experienced partial responses, with seven achieving at least 90% tumor cell reduction and living up to 25.1 months without cancer progression.
A recent study presented at EuroPCR 2015 found that routine thrombectomy during angioplasty for acute myocardial infarction may increase the risk of stroke. The TOTAL trial showed a significant increase in stroke rates within 30 days, with the highest risk period being within 48 hours.
A study comparing OCT and IVUS guidance found that OCT-guided stents had greater in-segment percent diameter stenosis but similar major edge dissection and malapposition rates compared to IVUS-guidance. The results suggest that OCT-guidance is a viable alternative to IVUS for guiding percutaneous coronary interventions.
A US forest service research team has released bats treated for White-nose Syndrome (WNS), a deadly fungus that has killed an estimated 5-6 million bats. The treatment, developed with native soil bacteria, showed promising results in field trials and could potentially reduce mortality of bats affected by the disease.
Women who participate in clinical trials are more likely to experience positive emotions and fewer negative emotions than those who do not. The study suggests that recruiters should disclose the potential for regret and other negative feelings when participants opt out, to increase enrollment.
The DATECAN initiative has published guidelines for time-to-event end point definitions in breast cancer trials, aiming to standardize endpoint usage. This guidance helps researchers compare clinical trial results and make informed decisions about treatment efficacy.
A Cancer Research UK study found that pre-surgery chemotherapy reduces side effects and hospital stays, leading to a better quality of life for patients. The trial challenged the international standard for treating advanced ovarian cancer.
A study found that music intervention reduced heart rate, respiratory rate, anxiety, and dyspnea in patients undergoing daily weaning trials from prolonged mechanical ventilation. However, further research is needed to test benefits in a larger sample and earlier in the weaning process.
A new study found that TAVI is safe and effective as a surgical alternative for selected lower-risk patients, with comparable outcomes at two years. The Nordic Aortic Valve Intervention (NOTION) trial showed no significant difference in mortality rates between TAVI and surgical valve replacement.
Swedish clinicians have successfully performed live births after uterus transplantation, paving the way for new treatments. The long research journey of the Swedish uterus transplant project has led to preliminary results that offer hope for women who lack a functional uterus.
A team of researchers, led by Dr. Steve Bellan and including Associate Professor Manoj Gambhir from Monash University, have identified the most effective human trial design for testing Ebola vaccines in Sierra Leone. The study suggests that a modified randomized control trial is the best approach to detect an effective and safe vaccine.
A new method of oxygen delivery, high-flow nasal oxygen therapy, was found to be non-inferior to traditional noninvasive ventilation in treating postoperative respiratory failure. The study compared outcomes between 830 patients who received either high-flow nasal oxygen therapy or bilevel positive airway pressure.
The COSMOS trial enrolls 18,000 participants to examine the long-term cardiovascular health benefits of cocoa flavanols. The study also explores potential benefits on brain health and metabolic health.
A new screening method can detect twice as many women with ovarian cancer as conventional strategies, according to the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). The method uses a statistical calculation to interpret changing CA125 levels in women's blood, providing a more accurate prediction of individual risk.
After 10 years of experience with LVRS, the results demonstrate durable benefits in improving airflow, exercise capacity, and dyspnea. Functional improvements are stable for five years, making Surgical LVRS the gold standard for treating advanced emphysema.
A recent study compared cardiac surgery residents to attending physicians performing coronary artery bypass grafting and found similar patient outcomes and graft patency. Residents acted as primary surgeon in majority of surgeries, but with proper supervision, they achieved comparable results to attendings.
The Helmsley Charitable Trust has launched a global type 1 diabetes prevention initiative, investing $8.7 million in international grants to support observational studies and clinical trials. The project aims to identify new pathways to prevent the disease through data analysis and intervention clinical trials.
The ASCENDE-RT1 trial found that permanent radioactive implants (brachytherapy) reduced prostate cancer recurrence by 50% at five years compared to dose-escalated external beam radiotherapy. LDR-PB also showed an overall survival advantage, but with more urinary side effects.
A recent study analyzed 58 papers on inflammatory bowel disease and found inconsistent methods reporting, leading to difficulties in reproducing experiments. The researchers developed a critical checklist to address the issue, recommending its adoption as a publication requirement to improve study quality and standardization.