Articles tagged with Clinical Trials
A study found that only 4% of published clinical trials mentioned FDA inspection violations, despite 74% having protocol violations. The FDA's lack of transparency and notification to journals contributes to this issue, making it difficult to track research misconduct.
A primary care-based program has been shown to increase physical activity in overweight, middle-aged women, with improvements of up to 90 minutes per week compared to self-guided groups. The interventionist-led group also maintained higher levels of activity over time.
A randomized trial assessing resident duty hour schedules in the ICU found that shorter hours may be less safe for patients and not associated with reduced fatigue. Longer shifts were linked to more severe symptoms of fatigue among residents. The study suggests trade-offs between residents' well-being and patient safety.
Research concludes that historical dietary guidelines on fat consumption in the US and UK were not supported by solid trial evidence. The analysis of six relevant trials found no difference in deaths from coronary heart disease between treatment and comparison groups.
Researchers developed a video game to measure upper extremity movement in patients with muscular dystrophy, highly correlating scores with daily activities and mobility. The game, using Kinect technology, measures patient performance and can be used across sites internationally.
A joint QUT, Cancer Council Queensland, and University of Queensland study tested the impact of SMS-delivered messages on skin cancer prevention and promotion. The Healthy Text trial found that texting improved self-reported sun protection habits and increased skin self-examination among participants.
A new clinical trial is exploring the use of breast MRI and genomic testing to guide treatment decisions for women with ductal carcinoma in situ (DCIS) breast cancer. The study aims to determine whether MRI findings can reduce the number of unnecessary mastectomies, a common concern among patients with DCIS.
A new course of action prescribing chemotherapy based on genetic research has led to a Phoenix resident being diagnosed with no detectable tumors after Stage 4 pancreatic cancer treatment. The patient benefited from a cutting-edge clinical trial and is now part of a follow-up study testing the effectiveness of a maintenance therapy.
The Liberia-NIH partnership is conducting a Phase 2/3 study to test the safety and efficacy of two experimental vaccines against Ebola virus infection. The trial will enroll approximately 27,000 healthy adults and those at high risk of infection, and will provide crucial information on potential countermeasures for future outbreaks.
A large randomized trial in the US found that adding STAN to conventional intrapartum fetal heart rate monitoring did not improve perinatal outcomes or decrease operative deliveries. The study's results highlight the need for caution when extrapolating results from studies outside the US.
The DFG is funding four new clinical trials addressing urgent questions in patient-oriented research, including surgery for metastatic stomach cancer and individualised chemotherapy for certain breast cancers. Over 1,160 patients will participate in the trials, which will test efficacy of new procedures over a three-year period.
A smartphone app improved some sun protection behaviors, including increased shade use and combined use of all sun protection behaviors. However, there was no significant difference in sunburns between groups. Strategies to increase mobile app usage are needed for effective deployment.
The GSK/NIH Ebola vaccine candidate has shown a well-tolerated safety profile and generated an immune response in healthy volunteers. Larger trials are necessary to assess whether the immune responses offer protection against Ebola infection and disease.
A clinical trial at Temple University Hospital is investigating the effectiveness of a vibrating capsule in alleviating symptoms of chronic constipation. The non-drug therapy involves a tiny motorized capsule that vibrates to stimulate intestinal contractions and help move stool through the digestive tract efficiently.
The University of Louisville is conducting a study to evaluate the safety and effectiveness of an investigational device called Zephyr Endobronchial Valve (EBV) for treating emphysema symptoms. The EBV blocks off diseased lung sections, allowing healthier parts to expand.
The Alzheimer's Association has awarded nearly $4 million in new grants to support five Phase 1 and 2a clinical trials exploring innovative treatments for Alzheimer's disease. These grants will help bridge the gap in funding for early-phase clinical drug trials, supporting promising projects from academia and industry.
Researchers developed a breast cancer risk prediction model specifically for African-American women, using data from 55,000 women. The new model predicts higher risk and is expected to increase the number of African-American women invited to participate in prevention trials.
The American College of Physicians marks its centennial year with a focus on the role of internal medicine in healthcare systems, professional satisfaction, and cost control. The journal also explores the challenges of sharing clinical trial data, highlighting the need for a consistent approach to balance benefits and risks.
The SPECTAcolor platform has successfully implemented across 19 European clinical centers, recruiting over 500 patients and providing high-quality biological materials. Preliminary analysis reveals mutations in key cancer biomarkers, including KRAS, NRAS, BRAF, PI3K, and mismatch repair.
The National Institute of Allergy and Infectious Diseases has awarded contracts to three organizations to conduct early-stage human clinical trials for investigational infectious disease treatments. The trials will test the safety of novel drugs against a range of emerging and re-emerging pathogens, including viruses and bacteria.
A new study found that reducing fear avoidance beliefs is crucial for improving symptoms and reducing disability in people with chronic fatigue syndrome. The analysis of PACE trial data revealed that graded exercise therapy (GET) was more effective than cognitive behavior therapy (CBT) in reducing fear avoidance beliefs.
Researchers from Inserm confirm triheptanoin's efficacy in treating Huntington's disease by restoring normal brain energy metabolism. A pilot clinical trial with ten patients showed significant improvements, paving the way for a larger-scale trial.
A prospective randomized controlled trial found that laparoscopic shunt placement reduced distal shunt failures, a common complication of ventriculoperitoneal shunt surgery. The study also showed comparable overall shunt malfunction rates and hospitalization times between the two groups.
A Phase 1B clinical trial in Uganda found the experimental vaccines safe and induced immune responses in healthy volunteers. The results are encouraging, as similar immune responses were observed compared to a previous US trial.
A study found that deeper or longer duration cooling did not improve outcomes for full-term infants with moderate or severe hypoxic ischemic encephalopathy. Longer cooling and deeper cooling has been shown to be neuroprotective in animal models, but its effectiveness was not observed in this trial.
A clinical trial has shown that a combination of well-known approved drugs is potentially safe for treating Charcot-Marie-Tooth type 1A disease, a rare genetic condition affecting 1 in 5,000. The drug combination, PXT3003, showed promising preliminary results for efficacy in improving symptoms and nerve function.
A new study by Clemson University researchers found that almost half of patients who participated in a trial withheld clinically sensitive information from their healthcare providers. Patients were given control over how and to whom their medical data was shared, but some still chose to hide certain information.
A randomized clinical trial found intra-arterial treatment improved functional outcome by 71% over medical management with tPA alone. The study showed benefits for all ages, including the elderly, and demonstrated effectiveness up to 6 hours after stroke onset.
In a six-month trial, 49% of patients withheld clinically sensitive information from their healthcare providers. Patients sought control over who accessed their records, but doctors had mixed reactions. The study aimed to balance individual privacy with healthcare providers' needs for relevant data.
A new model for measuring acceptability of a long-acting contraceptive vaginal ring was tested among 1,036 women in a Phase 3 clinical trial. The study found that 89% of women were satisfied with the ring and had easy insertion and removal. Continued research is recommended to broaden the evidence supporting its use.
The EORTC10085/TBCRC/BIG/NABCG International Male Breast Cancer Program found significant improvements in survival for men with breast cancer, but not as high as for women. The study revealed distinct biological characteristics of male breast cancer, including lower rates of hormonal therapy and breast-conserving surgery.
A phase III clinical trial found that treatment with progesterone after traumatic brain injury provided no significant benefits compared to placebo. The study involved 49 trauma centers and 882 patients, but was stopped early due to safety concerns.
A new study in The Lancet has found that combining insecticide spraying with bed nets offers no additional protection against malaria. In fact, the researchers suggest that investing more resources into providing bed nets may be a more effective solution to tackle malaria, as it is a low-cost and cost-effective method.
A new analysis found that nearly two-thirds of elderly women with early stage breast cancer continue to receive radiation therapy despite clinical trial data suggesting it may not be effective. The findings highlight the challenges in implementing clinical trial results into practice patterns, particularly due to concerns about long-te...
The latest trial results show a response rate of over 90% among pediatric acute lymphoblastic leukemia patients, with complete responses in 92% and remission rates of 70%. The therapy also demonstrates promise for non-Hodgkin lymphomas, including a 100% response rate in follicular lymphoma patients.
A recent clinical trial found that young adults with acute lymphoblastic leukemia (ALL) who received high-intensity pediatric protocols had better overall survival rates, with 78% achieving overall survival and 66% maintaining event-free survival. This is a significant improvement over previous studies for this age range.
A recent study published in the Journal of Applied Physiology reveals that elite Kenyan runners maintain stable cerebral oxygenation during maximum physical effort, contributing to their success in long-distance races. This stable oxygenation is linked to early lifestyle factors such as prenatal exposure to high altitudes and regular c...
Pragmatic clinical trials require collaboration between researchers and health care providers. A new guide emphasizes building strong partnerships, defining clinically important questions, and involving stakeholders in study design. Successful trials produce long-term scientific relationships and evidence for improving care.
A new lung cancer risk model, PLCOm2012, refines decisions to screen individuals for annual CT scans, identifying a risk threshold for selecting high-risk smokers. The study found that this threshold resulted in higher sensitivity and specificity than the USPSTF criteria.
A new long-term clinical trial found that Lung Volume Reduction Coil treatment is safe over a 3-year period. Half of the patients showed continued improvement in lung function capacity and overall quality of life.
The NIAID/GSK Ebola vaccine candidate was well-tolerated and produced immune system responses in all 20 healthy adults who received it. The vaccine induced a T-cell response, including CD8 T cells, which may play an important role in immune protection against Ebola viruses.
A new powdered measles vaccine has been found safe and effective in early human testing, with no clinically relevant side effects reported. The dry powder vaccine was delivered through a puff of air and showed promise as an alternative to traditional injectable vaccines.
The investigational drug AG-120 has demonstrated 'extremely promising' early phase 1 clinical trial results for patients with acute myeloid leukemia (AML) harboring IDH1 mutations. This finding builds on previous phase 1 results of a related drug, AG-221, and offers hope for the treatment of this high-risk population.
A new study by researchers at Michigan Medicine reveals significant variations in the quality and content of clinical cancer guidelines. The guidelines, published within the last six years, have average scores ranging from 27% to 90%, suggesting a wide disparity in treatment recommendations.
A study of 95,766 Danish participants found that genetically low vitamin D levels were associated with increased all-cause mortality and cancer mortality. However, the study did not find a link between vitamin D levels and cardiovascular mortality.
A new study suggests that adding mitral valve repair to coronary artery bypass grafting does not significantly improve patient outcomes. The trial found no differences in mortality, readmissions, or quality of life between the two groups at one year.
A clinical trial found that hyperbaric oxygen treatment did not improve postconcussion symptoms in military members, but both the treatment and sham groups showed improvements compared to those who received no supplemental air chamber treatment. The study suggests that the observed improvements may be due to placebo effects.
A UCL-led experiment found that people are willing to inflict an average of 20p per shock on themselves and 40p per shock on strangers in exchange for money, highlighting a surprisingly optimistic view of human nature. This contradicts previous studies claiming humans prioritize their own interests over others.
A chemotherapy regimen of procarbazine, CCNU, and vincristine (PCV) following radiation therapy improved progression-free survival and overall survival in adults with low-grade gliomas. This trial found patients with oligodendroglioma had better outcomes than those with astrocytoma or oligoastrocytoma.
A new gene therapy treatment has demonstrated effectiveness in a canine model of DMD, skipping exons to produce functional dystrophin protein. The treatment was well-tolerated and resulted in high levels of dystrophin expression, with muscle strength increasing at higher doses.
Researchers found that popular diets such as Atkins, South Beach, and Weight Watchers result in modest weight loss at one year, but no significant impact on cardiovascular risk factors. The study suggests that a broader lifestyle intervention involving doctors and other health professionals may be more effective for long-term weight loss.
A phase 2 clinical trial found that combining ipilimumab with sargramostim improved overall survival by nearly five months and reduced serious side effects. The treatment combination also showed a higher one-year survival rate of 68.9% compared to 52.9% in the ipilimumab-only group.
A randomized non-inferiority trial found that sublingual misoprostol was less effective than intramuscular oxytocin in preventing postpartum hemorrhage in Uganda. The study showed that women treated with misoprostol experienced more blood loss and side effects, while oxytocin was associated with fewer complications.
UC San Diego has been designated as one of three 'alpha clinics' by the California Institute for Regenerative Medicine to accelerate clinical development of emerging stem cell therapies. The designation will support the establishment of a comprehensive regenerative medicine clinical hub and attract patients, funding agencies, and study...
Clinical trials conducted in East Germany between 1983 and 1990 involved over 14,000 patients and 68 Western companies. Despite some strict regulations, the country's desperation for hard currency led to trials with potentially ethically uncertain processes, but no evidence suggests systematic harm to patients.
The NIH is conducting an early phase trial to evaluate the VSV-ZEBOV vaccine candidate, which was developed by researchers at Canada's National Microbiology Lab. The trial will enroll 39 healthy adults aged 18-65 and assess the vaccine's safety and ability to generate an immune response.
Researchers have discovered a molecule, IGF-1, that can induce the production of T-reg cells, suppressing symptoms of autoimmune diseases. The findings confirm IGF-1's direct action on T-reg cells, making it a promising therapeutic option for conditions like type-1 diabetes and multiple sclerosis.
A recent study by the University of Birmingham has found a lack of consistency in assessing patient outcomes in clinical trials. This inconsistency can lead to biased and poor-quality data being used to inform policy decisions.
A Mediterranean diet supplemented with extra-virgin olive oil or nuts helps reduce central obesity and blood glucose levels, reversing metabolic syndrome in 28.2% of participants. The study found no significant difference in new cases of metabolic syndrome between the two diet groups.
The University of Maryland School of Medicine has begun a clinical trial in health care workers in Mali to evaluate a promising experimental Ebola vaccine. The vaccine, developed by the Vaccine Research Center at NIAID, has shown highly protective immune responses in animal model challenge studies.