A new recombinant tuberculosis vaccine is being tested in a Phase I clinical trial in the United States, combining two proteins known to stimulate strong immune responses in humans. The vaccine aims to offer protection against pulmonary TB, the most contagious form of the disease.
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A review of 26 studies found that cancer patients enrolled in clinical trials did not have significantly better health outcomes compared to those not participating. The studies highlighted the importance of clinical trials in advancing treatment and improving options for patients with cancer.
A review of 26 studies found some evidence that cancer trial participants had better outcomes, with three studies suggesting improved outcomes. However, the limitations of the data made it difficult to establish a definitive link between trial participation and improved outcome.
A new vaccine for genital herpes is being tested in a clinical trial, aiming to protect women against this sexually transmitted infection. The vaccine has passed preliminary safety and effectiveness testing and is now enrolling approximately 7,550 healthy female volunteers between 18-30 years old.
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A Phase II trial of Herceptin combined with chemotherapy found no significant difference in survival times between the treatment and control arms. However, a small subgroup of patients with extremely high levels of HER2 over-expression showed improved response rates and longer disease progression-free periods.
Recent evidence from randomized trials on hormone therapy and hypertension treatment led to a decline in hormone therapy prescriptions following publication of trial results. Alpha-blocker prescriptions also declined after the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) early termination.
The first human trial of a DNA Ebola vaccine opened at the NIH Clinical Center in Bethesda. Twenty-seven volunteers will receive either the investigational vaccine or a placebo injection over two months and be followed for one year.
Researchers at the University of Pittsburgh Medical Center have identified protein biomarkers that accurately diagnose ALS with near 100% specificity and sensitivity. The findings may lead to a new test for early-stage ALS, enabling faster diagnosis and monitoring of treatment efficacy.
The NIA is concerned about the growing use of testosterone replacement therapy without sufficient scientific information. Short-term studies are recommended to determine potential risks and benefits for symptomatic older men with low testosterone levels. Longer term trials will assess risks and benefits for these conditions, such as fr...
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A randomized clinical trial found that endoscopic fetal treatment increased survival to 73 percent for infants with severe CDH, while a comparison group with standard care reached 77 percent. The strongest predictor of survival was the size of the fetus' lungs at diagnosis.
The study, which took place from October 1999 to December 2002, showed a lower sepsis and device infection rate compared to the REMATCH trial. Patients lived an average of nine months with the device, with three still living as of November 1, 2003.
A recent clinical trial study suggests that patients are more concerned with factors such as interest in a new medication and potential health benefits than conflicts of interest. Despite efforts to minimize conflicts of interest, patients showed varying levels of trust in different sponsors.
A new implantable device called OPTIMIZER II has shown promise in treating heart failure by strengthening the heart's contraction using an electrical signal. The study enrolled 25 patients with moderately severe heart failure and found a statistically significant improvement in ejection fraction and quality of life.
The panel concludes that researchers should establish a 'bank' with the fewest number of cell lines that reflect the most Americans, prioritizing white Americans but including HLA types common in other ancestral groups. This would enable faster clinical research and ensure fair access to therapies.
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A triple therapy study using ZADAXIN in combination with pegylated interferon alpha and ribavirin showed a 61% response rate for patients with hepatitis C who were non-responders to previous treatment. The study found that ZADAXIN improved response rates for these patients.
A recent study found that practice type and patient race are significant predictors of enrollment in clinical trials. Academic settings and white patients showed higher rates of trial participation, while non-academic sites and African-Americans had lower rates.
A study analyzed patterns of SNB use in academic comprehensive cancer centers and found that its use was associated with breast-conserving surgery. The procedure's popularity increased over time, from 8% in 1997 to 58% in the last half of 2000.
A study by Duke University Medical Center researchers demonstrates that training research coordinators on a human simulator prior to a complex clinical trial can significantly improve their confidence in their abilities. The training improved the coordinators' confidence levels, with an average increase from 5.7 to 8.12, and also led t...
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A study found that physicians have distinct approaches to explaining clinical trials, which can impact patient enrollment. The research suggests that understanding these differences is crucial for improving doctor-patient interactions and overall care.
A recent study reveals that African American and Hispanic children are disproportionately represented in clinical trials, with 26% of participants being African American. Despite lower representation among the overall U.S. population, these groups are overrepresented in potentially stigmatizing research studies.
The ACRN, a partnership of NHLBI and eight clinical centers across the US, conducts well-designed clinical trials for asthma treatments. Penn State's Data Coordinating Center leads expertise in biostatistical design and analysis.
The NIH has awarded $51 million to fund the Autoimmunity Centers of Excellence program, which aims to develop new immune-based therapies for autoimmune diseases. This expansion will enhance interactions between scientists and clinicians to accelerate translation of research findings into medical applications.
A new study examined lipid data from the DASH-Sodium Trial and found no notable increases in blood lipid levels among participants on low, intermediate, or high sodium intake levels. The findings are significant for public health recommendations to reduce sodium intake and lower high blood pressure.
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The European CanCer Organisation warns that the definition of a trial sponsor may lead to the collapse of independent clinical trials, particularly in children's cancers and rare adult cancers. Publicly funded clinical trials will be forced to stop due to financial and administrative burdens.
A meta-analysis of 14 trials showed no survival benefit with chemotherapy, but adjuvant radiotherapy resulted in a 7% higher mortality rate. Professor Thatcher suggests further research is needed to confirm the result.
Two studies presented at the Heart Failure Society of America annual conference show that an experimental respiratory-pacing device, inTone TM, significantly improves heart failure patients' ejection fraction, pulmonary artery pressure, and quality of life. The device's non-invasive therapy is delivered through a 15-minute session twic...
A new trial has shown that faster radiotherapy can improve head and neck cancer treatment outcomes, with a 60-70% benefit in tumour control and better voice conservation. The study found that accelerated treatment was linked to high EGFR expression and good tumour differentiation.
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Victoria Hale, Institute for OneWorld Health leader, joins Leadership Foundation Fellows Program to develop skills and share insights with women leaders worldwide. She aims to leverage powerful connections and partnerships to drive institutional change.
A malaria vaccine trial has begun in Mali with support from NIAID, aiming to prevent the deadliest form of malaria. The FMP-1 vaccine, developed by WRAIR and GSK Biologicals, will be tested on 40 adults for one year to assess its safety and efficacy.
The CHARM Programme demonstrates clear benefits of Atacand in treating heart failure, reducing risk by 23% in ACE-inhibitor intolerant patients and 15% in those taking conventional therapy. Additionally, Atacand shows a trend towards reduced cardiovascular death and hospitalizations in patients with preserved left ventricular function.
Researchers found that a combination of low-dose spiral CT and selective use of PET can effectively detect early-stage lung cancer in high-risk individuals. The study showed that lesions up to 5mm can be safely followed up after 12 months without major risks of progression.
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The ADOPT-A trial demonstrates the effectiveness of the AF Suppression algorithm in reducing symptomatic atrial fibrillation (AF) burden. The study found a significant 25% reduction in symptomatic AF episodes in patients using the algorithm compared to those with standard pacemaker indications.
A recent study tested pentosan polysulfate sodium and hydroxyzine hydrochloride on patients with interstitial cystitis, a debilitating condition affecting millions. The trial found that neither drug provided statistically significant relief for patients, but gained valuable information for future clinical trials.
NC State statisticians Drs. Anastasios Tsiatis, Marie Davidian and Marc Genton have won a $1.125 million NIH MERIT Award for their work on statistical methodology in designing complex HIV clinical trials. Their research aims to develop sophisticated designs that can handle the variability of patients' responses to treatment.
A one-year study is being conducted at the University of Illinois Chicago to explore the effectiveness of botanicals in treating menopause symptoms. The research aims to determine whether these alternatives can provide relief from hot flashes and other symptoms, while also examining potential risks.
A clinical trial found that early treatment with Atacand significantly reduced 12-month mortality and vascular events in patients with acute ischaemic stroke. The study also showed a comparable tolerability profile to placebo.
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A study published in The Lancet found that carvedilol significantly reduces mortality and improves average life-expectancy by eight years compared to metoprolol. Additionally, carvedilol shows promise in improving ventricular function for patients with heart failure due to coronary artery disease.
CA4P, a vascular targeting agent, is being tested in humans for the first time to prevent and regress choroidal neovascularization, a major cause of vision loss in age-related macular degeneration. The trial is led by Johns Hopkins' Wilmer Eye Institute and funded by The Foundation Fighting Blindness, Inc.
A low-intensity CQI intervention successfully increased the use of preoperative beta-blocker therapy and IMA grafting in elderly patients, achieving significant overall effect and positive trends. The study demonstrates a Medical Specialty Society CQI Platform as a model for rapid translation of evidence into practice.
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Researchers at Vanderbilt University Medical Center found that a generalized rash on some smallpox vaccine recipients was not due to the virus, but rather a benign reaction called folliculitis. The study aimed to clarify this previously unwell-documented phenomenon and reassure physicians about accurate diagnosis.
The US patient underwent the second procedure in the revised Phase I human clinical trials at Penn State Hershey Medical Center. The Arrow LionHeart device has shown promising results in lengthening and improving the lives of patients with end-stage heart failure.
A recent meta-analysis has found that vitamin E and beta carotene supplements do not reduce the risk of cardiovascular disease or death. The analysis analyzed data from seven trials involving over 1000 participants, concluding that these supplements may even increase mortality rates.
A new report emphasizes the importance of subgroup analysis in clinical trials to detect sex differences, which could impact drug efficacy. The study highlights cases where inadequate dosing for women led to ineffective treatment outcomes, underscoring the need for better trial design and statistical analysis.
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The study shows that aspirin is likely a better choice than ticlopidine for recurrent stroke prevention in African Americans, who face higher stroke risks. Aspirin is readily available and inexpensive, while ticlopidine has serious side effects and is more difficult to use.
A new blend of cooking oil made from medium chain triglycerides (MCT) has been shown to heighten metabolism, lower cholesterol levels, and promote weight loss. In two clinical trials, participants who consumed the oil for 27 days experienced significant reductions in body fat and upper body fat, as well as improved blood lipid profiles.
The ITN multicenter islet transplant trial has confirmed that the procedure can be of great benefit to patients with serious and unstable type 1 diabetes. However, differences in success rates between individual clinical centers were noted, highlighting the need for expertise in islet preparation procedures.
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A new study found that the California law SB 37 has eliminated a major barrier to cancer clinical trial participation, with no patients citing insurance limitations as a reason. Participation rates have increased from 51% to 69%, but further awareness campaigns are needed to raise rates more dramatically.
A six-year study found that lung volume reduction surgery improves quality of life and survival rates for patients with upper lobe emphysema who are unable to exercise. The procedure did not show overall survival benefits, but identifying non-beneficial candidates is crucial.
A national multicenter trial confirms that lung volume reduction surgery (LVRS) significantly improves the quality of life and life expectancy for patients with severe emphysema. The procedure, which involves removing diseased sections of lung tissue, allows patients to resume routine activities without breathing difficulties.
Researchers have successfully completed the first phase of a clinical trial using a microelectronic retinal prosthesis, which is intended to restore vision in patients with severe eye diseases. The device, developed by Second Sight, LLC, has shown promising results, including the ability to detect light and distinguish between objects.
African American participants may resist behavior changes due to cultural discomfort. Researchers must consider socioeconomic status and acculturation levels when designing clinical trials. Culturally sensitive models can improve outcomes and build trust within the community.
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A study evaluated online resources for breast cancer clinical trials in Canada, finding that only 29% were listed. The US National Cancer Institute's PDQ Clinical Trials Database identified 86% of trials globally.
Researchers at Memorial Sloan-Kettering Cancer Center developed a mathematical model predicting lung cancer risk based on age, sex, and smoking history. The tool helps balance the risks and benefits of screening for high-risk individuals.
A recent pilot study published in the American Journal of Geriatric Psychiatry found that high-dose vitamins can reduce homocysteine levels in individuals with mild to moderate Alzheimer's disease. The multicenter trial, known as Vital, aims to determine if these vitamins can slow the progression of the disease. Researchers are optimis...
A study found that less than 20% of patients read the information sheet before giving consent, highlighting the need for verbal communication supported by written information. Patients with limited educational background had difficulty understanding the information sheet.
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BufferGel, a vaginal microbicide, maintains normal vaginal acidity to kill sperm and germs, preventing pregnancy. The compound is currently in advanced clinical trials for its ability to block HIV transmission.
A new trial found that routine electronic fetal monitoring, known as admission cardiotocography, has no impact on infant death or moderate to severe illness rates. The practice may also increase the risk of unnecessary interventions during childbirth.
A new AIDS vaccine strategy has been developed by Emory University researchers and is now moving to human clinical trials. The vaccine, which employs two different components, aims to induce the immune system to recognize HIV's distinguishing features, providing a safer alternative for HIV prevention.
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A team led by Professor Ram Sasisekharan at MIT has created designer drugs for preventing blood clots that can cause strokes and heart disease during surgery. The new formulations are more potent and effective than conventional forms of the drug, offering a potential alternative to existing treatments.
Researchers found that hormone therapy (HRT) significantly reduced the risk of developing type 2 diabetes among postmenopausal women with coronary heart disease and impaired fasting glucose. The study, published in Annals of Internal Medicine, suggests HRT may have metabolic benefits that outweigh the risks for certain high-risk groups.