Articles tagged with Clinical Trials
Researchers are examining whether attempting to turn breech babies earlier in pregnancy increases success rate and reduces C-sections. A manual procedure called external cephalic version (ECV) is being tested on approximately 1,000 women from around the world.
GSK has launched a Phase III trial evaluating its novel immunotherapy MAGE-A3 ASCI in patients with stage IB or II NSCLC. The trial aims to assess the efficacy and safety of MAGE-A3 ASCI as adjuvant therapy following surgery.
The International Committee of Medical Journal Editors (ICMJE) has updated its policy to align with the World Health Organization's Clinical Trials Platform. The revised policy now requires registration in a primary registry that participates in the WHO ICTRP for all trials beginning enrollment on or after July 1, 2008.
A Phase II clinical trial at M.D. Anderson Cancer Center found dasatinib achieves complete cytogenetic response in 77-95% of newly diagnosed CML patients, compared to historical data on imatinib. The rapid response rate suggests dasatinib may be more effective as a first-line treatment for CML.
A study of 519 patients found no benefit in overall survival from pre-operative chemotherapy for nonsmall cell lung cancer. Neo-adjuvant therapy did result in tumor down-staging and improved response rates, but its use should be targeted towards specific patient subgroups.
Researchers will identify Alternaria fungus antigens responsible for chronic sinusitis and its link to asthma. The goal is to develop new treatments and understand disease mechanisms.
A meta-analysis of eight trials found folic acid supplementation lowers the concentration of homocysteine in the blood, reducing stroke risk by an average of 18%. The study also revealed greater reductions in risk when treatment lasted over 36 months or reduced homocysteine levels by more than 20%.
A new system, TAME, assesses toxicity burden of cancer treatments by placing adverse events into three concise risk domains: short-term toxicity, long-term effects, and mortality risk. The method has identified differences of up to 500% in acute toxicity burden between certain cancer treatments.
A recent study found that guanfacine extended release significantly improved all core symptoms of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 17 years. The investigational nonstimulant medication demonstrated clinically meaningful efficacy for up to 24 months of treatment.
A long-term study of REMICADE found that patients with moderate to severe ulcerative colitis maintained improved clinical symptoms for up to two years after treatment. The study showed that 92% of patients had mild or no disease activity at week 56 and 97% at week 104, indicating sustained efficacy.
A minimally invasive device for stress urinary incontinence has been shown to be safe and effective in early clinical trials, demonstrating significant continence improvement in women. The device, ACT, eliminates the risk of overtreatment or undertreatment with adjustable balloons that can be adjusted post-operatively.
A nationwide study compared two surgical procedures for urinary stress incontinence, finding the fascial sling procedure significantly more effective than the Burch colposuspension technique. The SISTEr trial involved 655 women and found overall success rates of 47% for the sling procedure versus 38% for the Burch procedure.
Researchers are conducting a five-year Phase III clinical trial to examine the effectiveness of induced hypothermia as a therapy for brain swelling in children with traumatic brain injuries. The study aims to enroll 340 children and assess outcomes after one year, following cooling therapy.
The FDA-approved Perforomist Inhalation Solution is a long-acting bronchodilator that improves the quality of life for COPD patients. The solution was shown to be effective in treating chronic obstructive pulmonary disease (COPD) symptoms and improving lung function.
Researchers found that probiotics reduced the risk of necrotising enterocolitis in premature babies by 64% and the risk of death by 53%. The study also showed a significant reduction in sepsis risk and an average delay of three days in achieving full feeds. Further trials are needed to confirm these results.
Reolysin works synergistically with standard anti-cancer drugs, providing stronger responses than either agent alone. It also primes patients' immune systems against their particular cancer, leading to additional cancer cell killing and long-term remissions.
The review of six large-scale clinical trials found that aliskiren was not more effective than existing antihypertensive drugs in controlling blood pressure. The drug's inability to effectively lower blood pressure was attributed to its stimulation of kidney renin secretion, which can counteract its antihypertensive capabilities.
A new survey by Duke University Medical Center and Johns Hopkins University found that 41% of clinical trial coordinators have experience disclosing financial conflicts of interest, but many feel uncomfortable doing so. The researchers suggest that additional education and training are needed to address these concerns.
Researchers at the University of Pennsylvania School of Medicine have found that natalizumab reduces both visual loss and disability in patients with relapsing multiple sclerosis. Vision loss is a common symptom of MS, and this study provides strong validation for a simple measure of visual function.
A clinical trial at UCSF Brain Tumor Research Center has shown promising results using the vitespen vaccine to stimulate the immune system to attack tumor cells. The vaccine, made from a patient's own tumor, induced a tumor-specific immune response in all 12 study patients.
Early-stage breast cancer patients who receive a single method of treatment, such as tamoxifen or chemotherapy, have improved survival rates. Chemotherapy shows modest yet sustained benefits in relapse-free and overall survival, particularly in younger women and those without ovarian suppression.
Dr. Jayakrishna Ambati's research on macular degeneration has led to a breakthrough discovery that may help patients fight the condition. With a $750,000 grant, Ambati will develop a phase 1 clinical trial to test new therapies for age-related macular degeneration.
A major clinical trial shows that MRI scans can quickly identify cancer in the opposite breast of women diagnosed with cancer in one breast. The study found a 90% accuracy rate for detecting contralateral breast cancers.
A large trial in eastern Zimbabwe showed that a community-based program with integrated peer education, condom distribution, and STI management did not decrease the overall incidence of HIV-1. In contrast, male participants benefited from the program with a decrease in HIV-1 incidence, unprotected sex reporting, and STI symptoms.
A Phase 1 trial of mesenchymal stem cells (MSCs) has shown significant improvements in heart function and reduced side effects in patients with acute myocardial infarction (MI). The study, led by Joshua Hare, M.D., found that MSC-treated patients had lower rates of cardiac arrhythmias and improved heart, lung, and global function.
The EVEREST trial shows that oral tolvaptan improves patient-assessed global clinical status, body weight, and reduces dyspnea in hospitalized heart failure patients, while also measuring long-term effects on mortality and hospitalization rates.
A study published in JAMA found that rosuvastatin reduces the rate of progression of arterial thickening and stops but does not reverse atherosclerotic disease in middle-aged individuals with low Framingham risk scores and evidence of subclinical atherosclerosis. The medication also showed a similar safety profile to placebo.
The ABSORB trial demonstrated no stent thrombosis and a low rate of Major Adverse Cardiac Events after six months. The findings suggest that bioabsorbable drug-eluting stents may be a promising future therapy option for treating heart disease.
The NIH is launching a large-scale clinical trial to explore the potential of creatine as a treatment for Parkinson's disease. The study aims to slow the progression of the disease and improve quality of life for patients.
A University of Missouri study found that negative news stories about clinical trials deter people from participating in medical research. The study analyzed 216 New York Times and 124 Washington Post articles, revealing a significant correlation between negative coverage and decreased willingness to participate.
A clinical trial found that daily zinc supplements reduced the risk of death among children aged 12-48 months by 18%. However, no significant reduction was observed in mortality among children under 1 year old. The study suggests benefits for zinc supplementation beyond just reducing pneumonia, diarrhea, and malaria cases.
The NIAID has selected 60 U.S. and international institutions as HIV/AIDS Clinical Trials Units (CTUs) to conduct next-generation research on vaccines, prevention, and treatment. The CTUs will work together with clinical research networks to tackle critical research questions and accelerate progress against the HIV/AIDS pandemic.
The Microbicide Trials Network will conduct 17 clinical trials over seven years to determine if topical microbicides can prevent the sexual transmission of HIV in women. The network, supported by NIH, brings together international investigators and community partners to develop and evaluate microbicides.
The University of Wisconsin is conducting a clinical trial using adult stem cells to treat severe coronary artery disease. The study aims to investigate the efficacy and safety of blood-derived selected stem cells in improving symptoms and clinical outcomes in patients with chronic myocardial ischemia.
Postmenopausal women with minor or major ECG abnormalities are at increased risk for future cardiovascular events and death. The presence of these abnormalities should prompt physicians to consider further risk stratification and more intensive therapeutic interventions.
In response to criticisms of the Trial of Preventing Hypertension (TROPHY) study, investigators defend the work against claims of biased design. Experts argue over interpretation of data, including a change in hypertension definition and handling of home blood pressure measurements.
A new clinical trial has shown that intensive treatment for periodontitis, a common inflammatory gum disease, can improve blood vessel function and reduce the risk of heart attacks and strokes. The study suggests that treating gum disease could be an important step in preventing cardiovascular disease.
A meta-analysis of 68 randomized trials found that antioxidant supplements beta carotene, vitamin A, and vitamin E were associated with increased mortality risk. Vitamin C showed no significant association, while selenium use tended to reduce mortality risk.
A six-month study found that three forms of garlic, including raw and commercial supplements, did not significantly reduce low-density lipoprotein (LDL) cholesterol in adults. The results suggest that garlic may have other beneficial health effects, but its ability to lower LDL cholesterol is uncertain.
A new clinical trial aims to investigate whether low-dose aspirin can improve pregnancy outcomes for women who have miscarried. The study will enroll 535 women and follow them for five years to assess the impact of aspirin on implantation, blood flow, and preeclampsia.
Two randomized clinical trials found tamoxifen reduces ER-positive breast cancer risk by 27% and 39%. Long-term benefits persist even after stopping tamoxifen use, with reduced side effects.
A randomized controlled trial shows that low-dose hydrocortisone continuous infusion minimizes hyperglycaemic episodes and serious adverse events in critically ill patients with sepsis. Continuous infusion also reduces nurses' workload by requiring fewer insulin dose adjustments.
The exclusivity of clinical trial data could jeopardize efforts to create generic versions of life-saving medicines, harming public health. Karin Timmermans warns that data exclusivity can delay generic competition and drive up prices.
A new benchmark study finds that timeliness is a critical factor in the success of treatment for twin-twin transfusion syndrome (TTTS). The study, led by Dr. Timothy Crombleholme, highlights the importance of early diagnosis and aggressive intervention to improve survival rates. Fetal echocardiography is recommended as a crucial diagno...
A trial comparison found that COX-2 inhibitors like etoricoxib are associated with fewer upper gastrointestinal clinical events in patients with arthritis, compared to traditional NSAIDs like diclofenac. The study suggests that COX-2 inhibitors may be a safer alternative for pain management.
Patients with severe psoriasis receiving Remicade experienced significant improvements in skin and nail symptoms. The treatment achieved PASI 75 in over three-quarters of patients at week 10.
A new study at Wake Forest University School of Medicine found that women's conflicting attitudes towards participating in clinical trials are rooted in fears, distrust, and hopes for future benefits. The researchers called for greater involvement of academic medical centers with minority communities to address health concerns.
The study found that patients with higher nitric oxide levels had better survival rates, more ventilator-free days, and lower rates of organ failure. Lower tidal volume respiration was also associated with increased NO levels and improved outcomes.
The National Institutes of Health has awarded Temple University Hospital a $1 million grant to participate in the Neurological Emergencies Treatment Trials Network. The five-year study series aims to facilitate high-quality clinical trials for various emergency neurological disorders, including traumatic brain injuries and seizures.
A study found that three-fourths of cardiovascular clinical trials published in leading medical journals did not provide sex-based analysis, highlighting the lack of data on women's heart health. Researchers urge more women to be included in trials and for journal editors to require sex-specific reporting.
The International Harmonization Project has developed new guidelines for assessing lymphoma treatment, providing uniform criteria for clinical trials and interpreting response to treatment. The revised guidelines incorporate PET scans and immunohistochemistry, allowing for more accurate assessment of tumor viability.
A large international study involving 83 sites will test 3,000 patients to evaluate the impact of exercise training on death and hospitalization in heart failure patients. The trial, called HF-ACTION, is the largest randomized clinical trial of exercise training ever performed.
Researchers found that antihypertensive agents ARBs and ACE inhibitors are the least associated with incident diabetes, followed by calcium-channel blockers and placebo. The study provides a systematic review of clinical trials and finds highly coherent estimates that are robust to sensitivity analyses.
A mathematical model suggests that one-time screening of adults age 50 or older for malignant melanoma is very cost-effective, with costs totaling $10,100 per quality-adjusted life year gained. Screening every two years may also be cost-effective, depending on disease progression rates.
Researchers at Stanford University School of Medicine have used the antiviral drug valganciclovir to treat patients with chronic fatigue syndrome, with significant improvement in 21 out of 25 cases. The therapy has shown promise in reducing inflammation and improving symptoms.
A study published by Stanford University researchers found that the brain's neural activity can predict movement variability, contradicting the long-held assumption that consistency lies in muscle mechanics. The research suggests that flexibility and improvisation are key features of human movement.
The study found that herbal supplements including black cohosh did not reduce menopausal symptoms. In contrast, hormone therapy significantly reduced symptoms in postmenopausal women, highlighting the importance of well-designed research to evaluate complementary and alternative medicine approaches.
A randomized, phase III trial found that reducing dietary fat intake to 15% of total calories may prolong relapse-free survival in women with early-stage breast cancer. The study reported a 24% lower risk of relapse in the intervention group compared to the control group.
A clinical trial has found that a combination of nifurtimox-eflornithine offers a cure rate over twice that of current treatments for second-stage African trypanosomiasis. This combination also resulted in lower rates of adverse events, suggesting potential as a future therapy.
Abstracts on Soliris (eculizumab) will be presented at the ASH Annual Meeting, highlighting its potential to reduce thrombosis in paroxysmal nocturnal hemoglobinuria (PNH) patients. The therapy has shown promise in clinical trials with significant reductions in anemia and intravascular hemolysis.