Articles tagged with Clinical Trials
Researchers redefine remission in rheumatoid arthritis by introducing two new provisional definitions that aim to standardize treatment goals. The new definitions focus on disease activity measures, including tender joint count, swollen joint count, and C-reactive protein levels.
A recent study found that more than half of clinical trials exclude people based on their age or age-related conditions. This exclusion leaves healthcare providers in the dark when determining which treatment will best serve their patients.
Research found that folic acid lowers homocysteine in the blood, which should reduce heart attack risk. However, clinical trials showed no extra benefit due to high aspirin use by participants. The study suggests folic acid may still be beneficial for those not taking aspirin.
Researchers have developed Cornell Dots, nanoparticles that can light up cancer cells to aid in diagnosis and treatment. The FDA has approved the first clinical trial of these dots in humans, which will verify their safety and effectiveness in treating melanoma.
Douglas Rosenberg invests $3.5 million with Buck Institute to develop treatments for Alzheimer's disease based on small molecule screenings that show promise. The goal is to raise $10 million to get the new drug candidates into early clinical trials.
Researchers analyzed over 20,000 patients who took simvastatin and found that statins reduced major vascular events by the same amount regardless of CRP levels. The results suggest that baseline CRP concentration or inflammation status does not impact the benefits of statin therapy.
The development of core outcome sets for clinical trials requires patient input to ensure relevant outcomes are measured. The study emphasizes the importance of involving patients and clinicians in the process, while minimizing participant attrition.
Researchers will compare non-transplant eligible patients with implanted devices to those with current medical therapy, examining potential benefits for patients less advanced than current LVAD recipients.
The US lettuce industry faces significant economic losses due to dieback disease, caused by two soil-borne viruses affecting romaine and leaf-type lettuce. New romaine breeding lines SM09A and SM09B offer complete resistance to the disease and improved shelf life.
The Lancet Editorial backs the Academy of Medical Sciences' proposal for a single health research agency to streamline current arrangements and improve oversight. The new agency would house National Research Ethics Service and take responsibility for specialist research ethics approvals.
Quality of life measures are most useful in breast cancer clinical trials using non-biomedical interventions. The authors recommend including QOL measures as secondary endpoints in adjuvant therapy trials for vulnerable populations or when minimal survival difference is expected.
A study by the Rakai Health Sciences Program in Uganda found that male circumcision significantly reduced high-risk human papillomavirus (HPV) infection in female partners of HIV-negative men. The protection is partial, and safe sex practices remain essential. Circumcision also increased clearance of HPV infections in women.
A new study found that doctors' metaphors used to explain Phase III clinical trials played a significant role in whether patients agreed to participate. Most participants struggled to understand randomization, but those who paid close attention were unaffected by the metaphor used.
The Muscular Dystrophy Association has awarded $1.4 million to Repligen to complete preclinical work and initiate human clinical trials of a promising therapeutic compound for spinal muscular atrophy (SMA). The grant will enable the company to move its lead compound, RG3039, into phase I trials in healthy volunteers and patients with SMA.
A cluster-randomized clinical trial in Ethiopia found significantly higher nasopharyngeal pneumococcal resistance to macrolides in communities randomized to receive azithromycin compared to untreated control communities. This study highlights the impact of antibiotic selection pressure on developing antibiotic resistance.
Researchers have found a two-drug combination to be safe and active in newly diagnosed acute myeloid leukemia and myelodysplastic syndrome patients with additional diseases or poor performance status. The combination of 5-azacitidine and vorinostat has shown promising results, with 83% survival rate after 60 days.
A European research team has developed a form of therapy to treat Alpha-mannosidosis, a rare childhood disease causing mental retardation and hearing loss. The therapy, called Lamazym, aims to replace the missing enzyme in cells, increasing life expectancy and quality of life.
A new study published in Clinical Infectious Diseases found that cranberry juice had no significant effect on reducing the recurrence of urinary tract infections. Among participants who suffered a second infection, those who drank cranberry juice showed a higher recurrence rate compared to those who received a placebo.
Women with ductal carcinoma in situ (DCIS) who undergo radiotherapy after surgery experience a significant reduction in local cancer recurrences and invasive disease, with the effect lasting long-term. Treatment with tamoxifen also reduces recurrence rates, particularly in the opposite breast.
The personalized vaccine is effective in preventing recurrence among certain follicular lymphoma patients with a specific protein on their tumor cells. The vaccine improves disease-free survival by nearly two years compared to placebo treatments.
A new study has identified promising biomarkers for Huntington's disease that could be used to track disease progression and test potential disease-modifying treatments. Biomarkers were found in brain imaging techniques, including whole-brain and striatal atrophy, which increased at a higher rate in individuals with the disease.
A University of Pittsburgh study will test a technology-enhanced weight loss program using text messaging reminders and wearable exercise monitors. The study aims to compare the effectiveness of this intervention with a standard behavioral weight loss program.
The John Theurer Cancer Center will unveil 40 cutting-edge studies at the 52nd ASH Annual Meeting, featuring research on lymphoma, multiple myeloma, and blood disorders. Six investigators were first authors of 13 studies, solidifying their leadership role in cancer treatment.
Researchers developed a new treatment for sudden sensorineural hearing loss (SSHL) using insulin-like growth factor 1 (IGF1) gelatin hydrogels, with 48% of patients showing hearing improvement at 12 weeks and 56% at 24 weeks.
A six-month exercise program improved leg strength and flexibility in patients with post-thrombotic syndrome, a frequent complication of deep vein thrombosis. The study's findings support the potential benefits of exercise training for managing this condition.
A large study found implanted devices for heart failure patients are successful in 'real world' use, with survival rates comparable to those in clinical trials. Remote monitoring networks improved patient outcomes by providing earlier diagnoses and empowering patients to take charge of their health care.
A study found that yearly mammogram screening in women under 50 with a family history of breast cancer can lead to smaller, less aggressive tumors and improved survival rates. The research suggests that this approach could prevent up to two deaths from breast cancer per 10,000 screens.
The SESAME stent showed 100% technical and procedural success rates, with no major adverse cardiac events or complications at 30 days. At 9 months, patency rates were comparable to balloon expandable stents without embolic protection.
A new therapeutic implant has been proven to synchronize and strengthen a fading heart beat, reducing the risk of death by 24% compared to current treatment. The device therapy, called cardiac resynchronization therapy (CRT), also improves quality of life and reduces hospital admissions for worsening heart failure.
A Finnish study found that infant feeding with a highly hydrolyzed casein-based formula reduced the emergence of diabetes-predictive autoantibodies by about 50% among high-risk children. The study suggests that early dietary intervention can substantially reduce the initiation of the disease process leading to Type 1 diabetes.
A systematic review found that probiotics shortened diarrhoea episodes by around a day and reduced the risk of prolonged episodes by 59% in patients with diarrhoeal diseases. No serious adverse effects were reported.
A large randomized clinical trial found FGF-2 to be effective in regenerating human periodontal tissue destroyed by periodontitis. The study showed substantial restoration of tissues with positive outcomes over the long term, making it an attractive approach for restoring lost tissues.
Researchers at Rush University Medical Center are exploring the mechanisms of stroke recurrence in patients with intracranial atherosclerotic disease. The MoSIS trial aims to identify causes of strokes in these patients, which is estimated to occur in 25% within two years of initial stroke.
Lasofoxifene statistically reduced the overall risk of breast cancer and ER positive invasive breast cancer in postmenopausal women with low bone density. The study found a significant reduction in coronary events, strokes, vertebral fractures, and non-vertebral fractures.
The OHSU Doernbecher team is conducting a second phase of a landmark clinical trial to assess the safety and preliminary effectiveness of purified human neural stem cells as a potential treatment for infantile or late-infantile neuronal ceroid lipofuscinosis, a rare and currently fatal neurodegenerative disorder. The trial aims to eval...
Researchers used MEG to study brain activity in PTSD sufferers and healthy individuals, finding increased circuit activity on the right side of the brain. This hyperactive network is linked to involuntary flashbacks and post-traumatic stress disorder (PTSD) symptoms.
A randomized trial involving 17 black-owned barbershops in Dallas County, Texas found that the enhanced barber-based intervention resulted in greater improvement in hypertension control. The control rate for patrons with hypertension increased from 33.8% to 53.7%, an increase of 19.9%.
Parents of children with cancer reported feeling hurried and less well-informed about clinical trial protocols compared to adult patients. The study found that parents felt they had insufficient time to learn about the trials and asked fewer questions.
A new Women's Health Initiative report shows hormone therapy is associated with a higher incidence of invasive breast cancer and increased risk of death from breast cancer. The study found that postmenopausal women taking estrogen plus progestin had more advanced cancers with lymph node involvement, leading to poorer prognosis
Despite the PARTNER trial's promising results, surgical aortic valve replacement should remain the standard treatment for aortic stenosis. Transcatheter aortic-valve implantation (TAVI) is only suitable for patients at high risk who have decreased life expectancy and cannot undergo surgery.
A renowned gynecologic oncologist expresses concerns about a major ovarian cancer study, highlighting the need for targeted genetics-based treatments over delayed treatment timing. The study found no significant difference in survival rates between early and delayed chemotherapy groups.
A new clinical trial at The Children's Hospital at OU Medical Center aims to detect Retinopathy of Prematurity (ROP) in premature infants through a novel technique. If successful, the method could prevent blindness and save $1 million per child in lifetime support costs.
Researchers are conducting a national study to assess whether a targeted rehabilitation approach can aid stroke patients in leaving their homes more confidently. The study will compare outcomes of volunteer patients receiving the intervention with those not receiving it, aiming to improve physical capabilities and boost confidence.
A phase II clinical trial is underway to examine the efficacy of Revatio (sildenafil) in improving cardiac function for individuals with Duchenne muscular dystrophy. The six-month study aims to slow disease progression and increase life expectancy.
Researchers found that targeting epidermal growth factor receptor (EGFR) provides substantial clinical benefit for women with hard-to-treat triple-negative breast cancer. Adding cetuximab to chemotherapy doubled response rate and time to progression compared to chemotherapy alone.
A meta-analysis of eight clinical trials found that folic acid supplements did not reduce the risk of cardiovascular events, cancer, or death over a five-year period. The study showed a significant reduction in homocysteine levels with folic acid supplementation but no corresponding benefit for cardiovascular health.
A randomized controlled trial found that a structured weight loss program with free prepared meals, combined with one-to-one counseling, resulted in significant weight loss (up to 16 pounds) for participants. The program was maintained at two-year follow-up, suggesting long-term effectiveness.
A new drug targeting the MET receptor added benefit to erlotinib in patients with advanced lung cancer who express MET, improving overall survival and progression-free survival
Researchers at U-M are investigating adaptive clinical trials to improve the efficiency of clinical trials. The goal is to accelerate drug and device evaluation, improve safety for patients, and reduce costs. Adaptive clinical trials make adjustments based on accumulated data to identify effective treatments more accurately.
A new randomised trial shows that starting chemotherapy earlier does not improve survival or quality of life for women with relapsed ovarian cancer. The study found that patients who received early treatment experienced a faster deterioration in quality of life, including role, emotional, social, and fatigue symptoms.
A Phase 3 clinical trial conducted by GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases found that a genital herpes vaccine was ineffective in preventing the disease in women. The study, which involved 8,323 women aged 18-30 years, showed that the vaccine had an estimated 20% effectiveness rate.
A comprehensive review of 10 studies involving 711 patients found no evidence that acupuncture aids in stroke recovery. The researchers concluded that the existing evidence is negative, calling for large-scale trials to better understand its effects.
The Northwestern University-led trial assesses the safety and tolerability of human embryonic stem cell-derived oligodendrocyte progenitor cells in paralyzed subjects with spinal cord injuries. The goal is to evaluate if these stem cells improve neuromuscular control or sensation in the trunk or lower extremities.
A new treatment has been found to significantly reduce mortality rates among patients with severe aortic stenosis, while also improving their quality of life. The bioprosthetic-tissue valve treatment was shown to save lives and enable patients to walk, exercise, and engage in daily activities.
A multicenter study published in the New England Journal of Medicine shows that transcatheter aortic-valve implantation resulted in significantly lower rates of death among patients who cannot undergo surgery. The procedure demonstrated safety and effectiveness for this life-threatening illness in unsuitable candidates.
The Phase II study will establish the optimal dosing regimen and then be tested in Kenya, Mozambique, South Africa, and Uganda. The TB vaccine candidate has been shown to have an acceptable safety profile in early-stage clinical trials.
A growing concern is the increasing volume of clinical trials and systematic reviews published every day. The authors propose reducing unnecessary trials to prioritize truly systematic reviews, ensuring that patient needs are met through valid answers. Open access to these resources is also emphasized.
Researchers found that thigh-length stockings can reduce the risk of deep vein thrombosis (DVT) in stroke patients, a life-threatening form of blood clot. The study, which included over 3,000 patients from 112 hospitals, highlights the importance of using long stockings to prevent clots.
A US clinical trial demonstrated the strong safety profile of bone marrow-derived mononuclear cells in patients after a severe heart attack. The study found improvements in left ventricular ejection fraction and volumes at six months, suggesting potential benefits for cell therapy trials.
A meta-analysis of three trials found that stenting is associated with a higher risk of stroke than surgical endarterectomy, particularly in patients over 70. However, younger patients (under 70) can tolerate both treatments equally well.