Articles tagged with Clinical Trials
Interactive computer packages moderately increase knowledge about sexual health issues and are as effective as face-to-face interventions for improving knowledge. However, their effectiveness in addressing other concerns like psychosexual difficulties or relationship problems is unclear.
A large, randomized controlled trial found that a surgically implanted antibiotic sponge did not reduce the rate of sternal wound infections after cardiac surgery. The study contradicts previous results and suggests ethnic and regional differences may have contributed to the differing outcomes.
A recent study found that departures from trial protocols were more common for earlier-enrolled patients, with queries and protocol deviations increasing as enrollment frequency decreased. Simulation programs can help address these issues prior to subject enrollment.
The ACCORD Eye Study found that intensive blood sugar control and combination lipid therapy with a fibrate and statin slowed diabetic retinopathy progression by about one-third. This study provides evidence for the benefits of these therapies in slowing eye disease progression.
The NIH has renewed its food allergy research program, the Consortium of Food Allergy Research (CoFAR), with a $29.9 million grant for five more years. The program will expand to include research on genetic causes underlying food allergy and studies of eosinophilic gastrointestinal diseases.
A landmark study in the US has compared natural orifice translumenal endoscopic surgery (NOTES) to traditional laparoscopic surgery for gallbladder removal. The trial aims to assess safety, efficacy, pain levels, and cosmetic outcomes of NOTES, which may reduce post-operative infection, hernia, scarring, and pain.
A Cochrane Systematic Review found that music therapy, specifically rhythmic auditory stimulation (RAS), can improve walking speed and arm movements in stroke patients. RAS therapy was shown to be more effective than standard movement therapy, with an average improvement of 14 metres per minute.
A multi-institutional study found that extended use of anti-clotting drug enoxaparin significantly reduced the chances of blood clots in bedridden patients, especially those over 75 and female. The treatment also increased bleeding risk slightly.
A randomized controlled trial found that patients with chronic low-back pain and degenerative lumbar osteoarthritis who took glucosamine for six months showed no significant difference in pain-related disability, pain, or quality of life compared to those who received a placebo. The study suggests that further research is needed to det...
A new non-surgical treatment for uterine fibroids, ulipristal acetate (UPA), has shown promising results in reducing total fibroid volume and menstrual bleeding. Patients taking UPA experienced improved quality of life, fertility, and reduced symptoms.
The Phase I trial found low-dose, multi-dosing regimens of BCG vaccination safe in individuals with type 1 diabetes, with no severe reactions reported. A Phase II clinical trial is planned to investigate the safety and efficacy of BCG vaccination as a therapeutic agent for type 1 diabetes prevention or reversal.
A new meta-analysis of clinical trials finds that rosiglitazone is associated with a significantly increased risk of myocardial infarction, while the risk of cardiovascular death was not elevated. The study suggests an unfavorable benefit-to-risk ratio for the diabetes drug, raising concerns about its safety.
A four-year clinical trial will investigate the effects of weight loss and increased physical activity on quality of life and co-existing medical conditions in overweight breast cancer survivors. The study aims to reduce breast cancer recurrence risk and improve psychosocial problems.
The NHLBI is funding nine research grants to examine the effects of red blood cell storage time on patient outcomes. A large clinical trial, RECESS, will compare heart surgery patients' outcomes based on stored red blood cells' age.
The University of Utah researchers are making significant progress in understanding and combating Spinal Muscular Atrophy (SMA), a genetic disease causing progressive muscle weakness. With the support of Families of SMA, they have established a clinical trials network to test novel therapies and advance treatment options for children a...
A Cochrane Systematic Review suggests that giving patients oxygen during a heart attack may increase the risk of dying. Despite widespread use, there is little evidence that oxygen therapy improves outcomes for heart patients and may even cause further damage.
The Nottingham Respiratory BRU Clinical Trials Unit will offer clinical services to NHS patients with respiratory disease while recruiting volunteers for studies on new treatments. The unit aims to develop new drugs and therapies to help people manage their illness, including a study using a diabetes tablet for mild asthma.
The TARGIT-A trial found that targeted intraoperative radiotherapy (TARGIT) is non-inferior to whole breast external beam radiotherapy in reducing local recurrences. Patients who underwent TARGIT had similar recurrence rates to those receiving conventional radiotherapy, with lower rates of radiotherapy toxicity.
A phase II clinical trial by Mayo Clinic found that green tea extract, specifically epigallocatechin gallate (EGCG), had a significant response rate among CLL patients. The study showed that 69% of patients experienced a biological response to EGCG, with notable reductions in blood lymphocyte count and lymph node size.
Researchers at UT Southwestern Medical Center compared the outcomes of two surgical procedures designed to alleviate symptoms of stress urinary incontinence. Both procedures, transvaginal sling and transobturator midurethral sling, appear to be similarly effective in women up to 12 months after the procedures were performed.
A study of 549 newborns found that infants who underwent a newer surgical procedure were more likely to survive their first year without needing a heart transplant. After the first year, both procedures yielded similar results.
A large national clinical trial has shown that carotid artery surgery and stenting are equally effective in preventing stroke, with personalized treatment options available for individual patients. The study found excellent safety and long-term results for both symptomatic and asymptomatic patients.
The REDUCE trial found dutasteride to be effective in reducing the chance of a positive biopsy by 23% and preventing disease progression. However, more detailed analyses are needed to monitor long-term effects on cardiovascular health and selectively identify aggressive disease.
A study found that academic detailing increased prescribing of thiazide-type diuretics in counties with higher activity levels. The intervention led to a small increase in medication dispensing, but other factors may have blunted its impact.
A study published in the Journal of Urology found that girls with vesicoureteral reflux are at higher risk of new renal damage. Boys also showed signs of renal damage, although at lower rates. The study suggests that preventing febrile urinary tract infections is crucial for kidney health.
Peregrine's PS-targeting antibody bavituximab reactivates the immune system to attack and destroy cancer cells, potentially working synergistically with multiple therapies. The company plans to initiate two new Phase II trials in refractory and front-line lung cancer patients by mid-year.
A large U.S. trial found that two common mid-urethral sling procedures are similar in their chance of cure, but each has distinct risks. Women who underwent transobturator or retropubic surgery achieved equivalent levels of treatment success, with 78-81 percent experiencing dryness.
Researchers tested bosentan for idiopathic pulmonary fibrosis and found no significant improvements. In contrast, two-day neuromuscular blocking agent therapy improved survival in patients with severe acute respiratory distress syndrome (ARDS). Oral iloprost showed promise in preventing lung cancer among former smokers.
Researchers found that inhaled N-acetylcysteine (NAC) preserves more lung function in some patients with mild idiopathic pulmonary fibrosis than no therapy. This novel study provides encouraging evidence to pursue a potential treatment for IPF, a lung disease characterized by progressive scarring.
The S-ICD System detected 100% of induced and spontaneous episodes of irregular heart rhythms, offering a viable alternative to traditional ICDs. The system's subcutaneous implantation eliminates the need for lead placement in or on the heart, reducing complications associated with current therapy.
Experts warn that poor scientific quality and lack of oversight can undermine the entire scientific enterprise. The authors propose four key questions to answer when proposing human studies of new therapies to safeguard medical research advancement.
A recent study has found that high-dose vitamin D supplementation is associated with an increased risk of falls and fractures in older women. The research, published in the Journal of the American Medical Association (JAMA), revealed that women who received a single annual high dose of vitamin D had a higher rate of falls and fractures...
Researchers at Northwestern University led by Theresa Pape are testing if familiar voices can facilitate brain repair and improve coma recovery. The study found that subjects responded more to family voices compared to non-familiar ones, with activated brain areas appearing on MRI scans.
A recent trial in Ghana found that vitamin A supplementation did not reduce maternal mortality, contradicting previous findings from a Nepalese trial. The study showed similar rates of pregnancy-related and all-cause female mortality between the intervention and control groups.
The ObaapaVitA study in Ghana found that vitamin A supplementation had no significant impact on pregnancy-related mortality or female mortality rates. This result contradicts the earlier Nepal trial which showed a 44% decrease in maternal mortality with vitamin A supplementation.
The American Gastroenterological Association (AGA) will present exciting data on the treatment and research of GI disorders during Digestive Disease Week. The late-breaking clinical abstracts include promising findings on gut microbiota, functional gastrointestinal disorders, and more.
A new meta-analysis reports that hyperfractionated and accelerated radiotherapy regimens improve overall survival in non-small-cell lung cancer patients by 3% after 5 years. Modified fractionation of radiotherapy also shows benefits for small-cell lung cancer patients, although the difference is not statistically significant.
A multicenter NIH trial led by the University of South Florida found combination antibiotics to be effective in treating Chlamydia-induced reactive arthritis. The study showed significant improvement in patients treated with combination antibiotics, with 22% experiencing complete remission and no adverse side effects.
A single sigmoidoscopy examination between ages 55 and 64 significantly reduced colorectal cancer mortality by 43% and incidence by one-third in those screened. The study found a lasting protective effect of screening, with 59% of cases detected during screening and only a few post-screening detections.
The article warns that overly restrictive regulations in clinical trials are stifling innovation and hindering patient safety. The authors advocate for the development of study-specific standards to address these issues, ensuring a balance between protection and progress.
Researchers found that individuals with high competitiveness and sensitivity to rewards perform better without a monetary incentive, relying on 'proactive cognitive control' to guide their actions. Brain scans revealed changes in lateral prefrontal cortex activity linked to extra behavioral benefits.
Researchers developed a novel statistical model to guide targeted therapies based on molecular signatures in tumor biopsies, showing promising results in treating stage IV non-small cell lung cancer. The study found that four drugs targeting specific molecular pathways led to improved disease control and overall survival.
IGIV has preserved thinking abilities and significantly reduced brain atrophy and ventricular enlargement in mild- to moderate-stage Alzheimer's patients. The study also found a dose-related effect on brain ventricular enlargement, suggesting IGIV may spare brain tissue.
Chagas disease is a neglected cause of stroke, with nearly a third of patients developing severe heart problems. Screening for Trypanosoma cruzi infection and long-term oral anticoagulants may help prevent stroke recurrence.
A study found that older patients (age 80+), particularly those over 85, had higher in-hospital death rates and more complications after defibrillator or pacemaker implantation. Despite this, they were less likely to have other comorbidities or concurrent cardiac procedures.
Over 3,000 employees from Banco Santander will participate in the PESA CNIC-Santander trial, exploring the progression of early subclinical atherosclerosis and daily habits that influence its development. The project aims to improve current prevention strategies and identify risk factors for cardiovascular diseases.
Researchers found that only patients with a specific genetic mutation are eligible for gene therapy, which has shown promising results in treating Leber congenital amaurosis. Genetic testing can detect changes in the genome, but accurate interpretation is crucial to ensure correct treatment.
A $3.8 million grant aims to address cultural barriers and biases limiting minority participation in cancer clinical trials. A patient navigation model is being established to provide assistance and support to patients considering or enrolled in trials.
SNM's Clinical Trials Network has gained a new member, Eli Lilly and Company, which will support the initiative to facilitate the development of therapeutic medicines. The network aims to streamline drug discovery and integrate imaging biomarkers into clinical trials, ultimately leading to personalized diagnostics and therapies.
The revised CONSORT 2010 statement provides a checklist to ensure randomised controlled trials are reported transparently and reliably. The guidelines aim to improve the quality of trial reports, making it easier for decision-makers to evaluate the soundness of trial results.
A study of nearly 100 early-stopped clinical trials found that many positive treatment effects were exaggerated. Researchers recommend continuing trials for longer periods to ensure accurate estimates of treatment effects.
Researchers have discovered a new drug that targets the root cause of painful menstrual cramps, called dysmenorrhea. The compound, VA111913, has shown promise in Phase II clinical trials and could be available to patients in four years if studies continue to show positive results.
A new study by Harvard researchers found that replacing saturated fat with polyunsaturated fat can reduce the risk of coronary heart disease by 19%. Increasing polyunsaturated fat consumption as a replacement for saturated fats may significantly reduce the rate of heart attacks and cardiac deaths in the population.
A recent study found that deep brain stimulation significantly reduced seizure frequency in patients with refractory partial and secondarily generalized seizures, with a 56% reduction in seizure frequency by 2 years. The benefits of stimulation persisted long-term, with improved responder rates.
Researchers at Fox Chase Cancer Center found that 15% of clinical trials using terms like erectile dysfunction and hypoactive had exclusionary language for lesbians and gay men. Industry-sponsored trials were more likely to exclude these groups, often due to requiring patients in heterosexual relationships.
Researchers developed a 'Braccio di Ferro' robot to assist patients in learning arm movements again. The interactive robot helps patients perform correct movements, promoting motor system learning and improving movement ability.
A recent NIH panel has questioned 'VBAC bans' and advocated for expanded delivery options for women. The panel suggests that a trial of labor is a reasonable option for many women with a prior cesarean delivery, citing success rates of nearly 75 percent.
A second dose of gene therapy has proven safe and effective in animal studies, suggesting that patients who benefit from treatment in one eye may experience similar benefits in the other. The study found no signs of toxic side effects or interference from unwanted immune reactions.
Only 25 US states have enacted legislation covering cancer clinical trial costs, with varying requirements for scientific and ethical review. The study highlights the need for closer communication between lawmakers and oncology experts to improve research and patient care.
A study of 141 parents whose children died of cancer found that 13% considered hastening their child's death, especially in cases of pain. The study suggests that education and discussion about intensive symptom management may mitigate consideration of hastened death among parents.