Articles tagged with Clinical Trials
A recent paper published in Prostaglandins, Leukotrienes and Essential Fatty Acids identifies experimental design issues in neutral studies questioning the benefits of omega-3s for heart health. The study suggests that these issues may be responsible for the lack of significant effects on cardiovascular disease outcomes.
A new landmark national study by Northwestern Medicine found that allowing surgical residents to work longer hours without compromising patient safety improved patient care and resident training. The FIRST trial investigated 4,330 residents and 138,691 patients, with similar rates of complications in both groups.
Open discussion of shame and blame is crucial for helping teens who self-harm and their families move forward. Separate sessions allow parents and teens to process emotions before joint discussions, promoting healing and understanding.
Researchers at Mayo Clinic have developed a saliva gland test that can detect early Parkinson's disease. The test involves taking a biopsy of the submandibular gland, which has been shown to be effective in detecting the abnormal protein associated with the disease in 14 out of 19 patients.
A randomized clinical trial found that high-flavanol chocolate improved uterine artery Doppler pulsatility index but did not decrease the risk of preeclampsia or improve placental weight. The results suggest that flavanol content may not be the sole factor behind chocolate's effects during pregnancy.
A UT Southwestern study found no conclusive evidence supporting the use of more expensive biologic mesh materials over synthetic mesh in abdominal wall hernia repair. Despite their potential benefits, biologic meshes have not been proven to significantly reduce infections or erosions.
A randomized clinical trial found that mailing free nicotine patches to smokers without behavioral support increased 30-day smoking abstinence at six months compared to those who received no intervention. The study suggests general support for direct-to-smoker programs with free mailed nicotine patches.
Leading medical journals propose a mandate on clinical data sharing to improve the benefit to society from clinical trials. The ICMJE defines a clinical trial as any research project that prospectively assigns people to an intervention, and believes there is an ethical obligation to share data generated by interventional clinical trials.
A study found that text message reminders can significantly improve treatment adherence and reduce blood pressure in adults with high blood pressure. The intervention was particularly effective among patients who received interactive text messaging, which allowed them to change appointment times or languages.
A year-long intervention in 21 Australian towns showed a significant reduction in weight gain among women, with an average loss of nearly 0.44 kg compared to +0.44 kg in the control group. The study suggests that simple health messages can be an effective strategy for preventing weight gain in rural communities.
Researchers from the University of Birmingham conducted a trial finding that physiotherapy and occupational therapy do not improve 'activities of daily living' in patients with mild to moderate Parkinson's disease. The study suggests that resources should be reallocated towards more effective treatments.
A large-scale clinical trial has been launched in Brazil to evaluate a candidate vaccine for dengue fever, which affects half the world's population and causes 500,000 hospitalizations annually. The vaccine, TV003, aims to prevent the mosquito-borne illness with a robust antibody and cellular immune response.
A simplified three-dose intramuscular (i.m.) artesunate regimen has been shown to be non-inferior to the World Health Organization (WHO)-recommended five-dose i.m. or i.v. regimen for treating severe malaria in African children. The study, published in PLOS Medicine, found that 78% of children treated with the simplified regimen had ov...
The journal publishes methodology and statistics to design better trials, reducing publication bias. It features a new method to make cancer clinical trials more effective, with the first issue now available on ScienceDirect.
The Walter Reed Army Institute of Research is conducting a Phase 2 clinical trial to evaluate the safety and immunogenicity of an Ebola vaccine regimen in healthy and HIV-infected study volunteers. The trial includes two vaccine candidates and will assess their safety and immune response in volunteers up to 70 years old.
A new clinical trial is evaluating a method to pinpoint and spare healthy lung tissue during lung cancer radiotherapy using advanced image analysis techniques on 4D CT scans. The researchers aim to improve quality of life for patients by sparing functional portions of the lung.
A randomized trial in Kenya found that discontinuing cotrimoxazole (CTX) prophylaxis increased the risk of malaria, pneumonia, and diarrhea, as well as non-trauma mortality events. The study supports the continued use of CTX prophylaxis regardless of CD4 cell count or HIV/AIDS clinical stage in settings with high malaria prevalence.
A new study reveals that mandatory tumor tissue requirements in clinical trials delay treatment and reduce patient enrollment. Trials without these requirements show faster treatment initiation and higher enrollment rates.
Researchers are conducting one of the largest-ever long-term clinical trials of an artificial pancreas system to regulate blood sugar levels in individuals with type 1 diabetes. The trial aims to test the safety and efficacy of the system, which uses advanced algorithms and sensors to mimic a healthy person's glucose regulating function.
A randomized clinical trial found that higher monthly doses of vitamin D were associated with an increased risk of falls in patients 70 or older. The study also showed that these high doses had no benefit on improving lower extremity function.
A device developed by UVA researchers aims to automate blood-sugar levels in people with type 1 diabetes through two clinical trials, which could lead to FDA approval if successful. The artificial pancreas will be tested at nine locations worldwide, including Europe.
A study analyzed 787 phase II/III clinical trials sponsored by the National Clinical Trials Network, finding that increased competition, planning to enroll a larger proportion of the available population, and lack of new agents were associated with poor accrual. The researchers developed a multivariable prediction model to identify tri...
New research explores wearable device effectiveness in promoting healthy behavior, using a novel trial design that evaluates real-time settings. The study aims to provide insights into when wearable devices can help improve health and when they may exacerbate conditions.
A study by Case Western Reserve University School of Medicine found that a tailored video education program improved cancer patients' knowledge and reduced negative attitudes towards clinical trials. The PRE-ACT program was more effective than text-based information in encouraging participants to consider clinical trials.
The LUX-Lung 7 trial shows afatinib significantly improved progression-free survival, time-to-treatment failure and objective response rate compared to gefitinib. Afatinib is considered the EGFR tyrosine kinase inhibitor of choice for first-line treatment in patients with EGFR mutation-positive non-small-cell lung cancer.
A clinical trial found that stem cell transplantation did not provide significant improvement in sustained disease remission after one year for patients with difficult-to-treat Crohn's disease. However, some patients showed objective signs of disease disappearance and discontinued active treatment more frequently in the stem cell group.
A new study published in The Lancet found that annual blood tests for ovarian cancer screening may reduce mortality rates by up to 20%. The UK Collaborative Trial of Ovarian Cancer Screening showed a delayed effect on mortality between the screening and control arms, becoming significant after seven years.
The UKCTOCS trial found that ovarian cancer screening reduced mortality by an estimated 15-28% in the MMS group compared to no screening. Longer follow-up is needed to confirm these results and determine their cost-effectiveness.
A mathematical model developed by Duke researchers suggests that active surveillance could be a viable alternative to surgery and radiation for select patients with ductal carcinoma in situ (DCIS). The study found that older women and those with serious health problems may benefit from delayed treatment, while younger women may not. Th...
The number of industry-sponsored clinical trials has dramatically increased since 2006, while NIH-funded trials have declined substantially. This trend raises concerns about the influence of commercial interests on medical research, potentially compromising public health outcomes.
A prime-boost H7N9 influenza vaccine concept has shown promising results in a small clinical trial, demonstrating the potential for a single dose to provide protection. The vaccine, which combines a live but weakened virus with an inactivated booster, elicited a robust immune response in both young and older adults.
A phase III trial found that women with luminal A subtype of breast cancer had comparable 10-year disease-free survival rates regardless of whether or not they received adjuvant chemotherapy. In contrast, patients with non-luminal A subtypes who received chemotherapy were 50% less likely to have their disease recur in 10 years.
A phase IIR/III clinical trial investigates whether surgery or stereotactic body radiation can control metastasis while continuing breast cancer therapy. Researchers aim to define parameters for determining which patients benefit from this 'weeding the garden' approach.
A phase 1B clinical trial of the novel antidepressant NSI-189 has shown that the compound appears to be safe and may be effective against depression. The study found improvements in depressive and cognitive symptoms in study participants, with effects persisting for several months after treatment discontinuation.
A new study from Brigham and Women's Hospital found that sacubitril-valsartan can extend life expectancy by one to two years for heart failure patients with reduced ejection fraction. The therapy, currently used as standard care, was shown to improve overall survival by 16% and reduce hospitalization rates.
The new risk management plan aims to prioritize data quality, reduce costs, and decrease attrition rates in imaging biomarker-driven trials. By identifying risks at trial initiation and allocating resources effectively, the framework can help minimize variability and ensure reproducibility of data.
Scientists have unraveled the abilities of multinucleated giant cells, which help the body deal with bulky items that obstruct physiological processes. The treatment for systemic amyloidosis has been found to be effective due to the complement system's role in marking and destroying protein deposits.
A five-year trial of progesterone supplements for recurrent miscarriage shows no improvement in outcomes. Despite disappointing results, the PROMISE trial provides valuable insights into potential alternative treatments and highlights the importance of continued research into reducing miscarriage risk.
A Phase 2 clinical trial is underway to test a chikungunya vaccine in 400 healthy adult volunteers. The trial aims to assess the safety and immune response of the vaccine, which has shown promising results in previous studies.
A University of Pittsburgh-led trial found that a text message-based program successfully reduced binge drinking among 18-25 year olds. After 12 weeks, participants who received the full program reported an average of one less binge drinking day per month and a 12% reduction in binge drinking.
The EORTC trial 26101 found that bevacizumab treatment in progressive glioblastoma patients did not confer a survival advantage despite prolonged progression-free survival. The combination of bevacizumab and lomustine may prolong PFS but does not impact overall survival.
The TATORT-NSTEMI trial found no significant difference in major adverse cardiac events at 12 months between thrombectomy and standard PCI in NSTEMI patients. Thrombus aspiration also did not affect quality of life or functional class.
A new Ebola vaccine has been found to be well-tolerated and stimulate strong immune responses in adults in Mali and the US. The study's findings could offer crucial protection for contacts of patients with confirmed Ebola disease, helping to interrupt transmission.
A phase I clinical trial found that pevonedistat, a small-molecule inhibitor of the NEDD8-activating enzyme, was safe and tolerable in heavily pretreated patients with relapsed/refractory lymphoma. The therapeutic showed modest activity in these patients, with three achieving partial responses and 30 experiencing stable disease.
A new study improves BrainGate's user experience and performance with three software innovations, allowing users to control electronic devices without frequent recalibration. The advancements enable longer use sessions and improved accuracy, paving the way for a practical BCI assistive technology.
A large-scale randomized control trial found that computerized cognitive behavioral therapy (cCBT) offered little to no benefit over usual GP care in treating depression. Patients generally struggled with sustained engagement and highlighted difficulties with logging onto computer systems while clinically depressed.
A participatory breeding program assisted organic tomato growers in identifying key plant traits needed for optimal production, with flavor as the top priority. The program also revealed differences in fruit quality characteristics between organic and conventional growers, highlighting the importance of disease resistance and nutrition...
A meta-analysis of randomized clinical trials found that endovascular therapy improved functional outcomes and higher rates of independence at 90 days, but no significant difference in symptomatic intracranial hemorrhage or all-cause mortality. The study included data from 8 trials involving 2,423 patients with acute ischemic stroke.
Researchers from Brigham and Women's Hospital found that low-fat interventions were no more successful than higher-fat interventions in achieving and maintaining weight loss for periods longer than one year. Low-carbohydrate weight loss interventions resulted in greater weight loss compared to low-fat diets.
A follow-up study found that cognitive behavioural therapy (CBT) and graded exercise therapy (GET) improved fatigue and physical functioning in patients with Chronic Fatigue Syndrome, maintaining these improvements over time. The treatments also reduced the likelihood of seeking additional therapy.
The NRG Oncology/RTOG 0813 trial found SBRT to be well-tolerated in early-stage, centrally located non-small cell lung cancer patients. The highest dose level allowed by the protocol was reached without significant toxicity.
A team of Penn researchers analyzed 114 large animal studies on cartilage repair to determine adherence to federal guidelines. They found that most studies did not follow the guidelines, particularly when evaluating study outcomes, and suggested that a standardized reporting structure be implemented to improve translation.
A recent study published in Neurology found that only a quarter of headache clinical trials were registered in an approved clinical trial registry, despite a 2005 decision by major medical journals to prioritize trial registration. The study suggests significant selective reporting and potential issues with the peer review process.
A trial found that a collaborative care model using health risk assessment and counseling reduced the number of risk factors and preventative care deficits among older participants. The study demonstrated improved 8-year survival rates, with a mortality rate of 3.16 per 100 person-years in the intervention group.
The RTOG 9601 study found that adding anti-androgen therapy to salvage radiotherapy improved overall survival and reduced prostate cancer death. The treatment also showed no significant increase in radiation toxicity.
Current 20- to 29-pack-year smokers are at similar risk for lung cancer as 30+ pack-year former smokers who meet current guidelines. The study's findings suggest caution when recommending LDCT screening to this group due to untested assumptions and potential harms.
Patients with lower household income below $50,000 had 32% lower odds of participating in clinical trials compared to higher income patients. The study found that trial participation decreased as annual household income decreased from $50,000 or higher to between $20,000 and $49,999 and to less than $20,000.
The PARTNER II Trial showed promising findings for TAVR with the latest generation of balloon-expandable (SAPIEN 3) device, demonstrating low one-year mortality rates and improved symptom relief. The study also found a low rate of disabling stroke and paravalvular aortic regurgitation.
Consensus statements on intracranial pressure monitoring in sTBI provide a clear interpretation of clinical trial results. The statements help guide practicing physicians and researchers in managing patients with severe traumatic brain injury.
Researchers found no significant difference in new polyp formation between patients with vitamin D and/or calcium supplements and those without. The study's results contradict previous findings in models and smaller human trials, highlighting the need for further research on promising cancer prevention strategies.