Articles tagged with Clinical Trials
The NHLBI has stopped intensive blood glucose lowering treatment in a clinical trial of adults with type 2 diabetes, citing increased risk of death compared to standard treatment. Participants will now receive the less-intensive standard treatment.
Patients with moderate to severe plaque psoriasis receiving REMICADE experienced significant skin clearance improvements across four body regions, including head, trunk, and extremities. At week 10, 71-79% of patients achieved a PASI 75 improvement, with even greater success at 39-52% achieving a PASI 90 response.
Scientists query FDA about updating requirements for drug approval, citing limitations of current endpoints and methods. Researchers suggest alternative endpoints using new ophthalmic technologies like optical coherence tomography.
Researchers are exploring optimal dosage and timing for stem cell therapy in adults with strokes and newborns with ischemic injuries. Pilot studies indicate a 25% improvement in recovery, leading to plans for clinical trials within two years.
The use of clinical trials to inform Medicare coverage decisions disproportionately affects older women with comorbid conditions, differing significantly from the target population. This disparity highlights the need for more representative trial populations to ensure better value and improved outcomes for Medicare beneficiaries.
A candidate malaria vaccine showed strong immune responses in a small clinical trial conducted in Mali, where it was tested on 40 adults and is now being expanded to 400 children. The trial's promising results could provide new hope for fighting the disease that claims over 1 million lives annually.
A series of commentaries in Human Gene Therapy explores key controversies surrounding patient recruitment and trial management in gene therapy trials. The authors discuss the challenges of patients comprehending lengthy and technical study descriptions and consent forms, and propose innovative strategies for improving informed consent.
Using modified-release prednisone significantly reduces morning stiffness duration in RA patients by adapting to circadian rhythms. The new formulation has a higher mean relative change of -22.7% and reduced morning stiffness time by 44 minutes compared to standard prednisone.
A recent study by Children's Hospital of Pittsburgh found that adolescents and young adults with cancer are less likely to be enrolled in clinical trials for cutting-edge treatments. This can lead to lower survival rates compared to younger children, who have seen significant improvements in cure rates over the past 30 years.
A new questionnaire tool was developed to assess the informed consent process in clinical trials. The tool aimed to educate potential participants on the risks and benefits of taking part in research. However, the results showed that the tool did not improve informed consent in this experiment. Despite this, the study's findings provid...
A new protocol combining daily spontaneous awakening trials with spontaneous breathing trials results in better outcomes for mechanically ventilated patients, including shorter ventilation periods and earlier discharge. The study found that this approach improved clinical outcomes without increasing adverse events.
Researchers found that sirolimus reduced angiomyolipoma size by nearly 50% in TSC and LAM patients. Lung function also improved in LAM patients, with a 10-15% increase in expiratory air flow.
Researchers have developed a new method for presenting clinical trial survival data that includes all participants, overcoming the limitations of traditional Kaplan-Meier plots. This new approach provides a more accurate representation of treatment effects, enabling physicians and patients to better understand clinical trial results.
A recent study found that patients with severe COPD who received salmeterol-fluticasone (SFC) therapy had lower mortality rates compared to those treated with tiotropium. Additionally, SFC treatment was associated with better health status and fewer patient withdrawals.
Researchers found that anastomotic leakage rates were similar between patients with and without preoperative mechanical bowel preparation. However, patients who had mechanical bowel prep had fewer abscesses after anastomotic leakage. The authors advise abandoning mechanical bowel preparation due to potential drawbacks.
Stroke patients with mild to moderate impairments experience substantial improvement in upper limb function after just 2 weeks of constraint-induced movement therapy (CIMT). The effects are retained for up to 24 months, with significant improvements in quality of life, social participation, and activities of daily living.
A peptide vaccine for leukemia improved event-free survival by 8.7 months compared to non-responders, with 36% of responders experiencing complete cytogenetic remission. The vaccine targets cancer cells and induces a specific immune response in patients with HLA-A2
Results from two Phase I trials demonstrate clinical activity of ZOLINZA (vorinostat) combined with bortezomib in patients with relapsed and/or refractory multiple myeloma. The combination treatment showed partial or minimal responses in 48% of evaluable patients, suggesting potential for further evaluation in randomized clinical trials.
A UTSouthwestern urologist has used botulinum toxin A (Botox) injections to treat involuntary bladder contractions in quadriplegic patients. The treatment has shown promising results, enabling patients to regain control of their bladders and improve their quality of life.
Stereo mammography has been shown to reduce false positives by 49% compared to standard digital mammography, potentially cutting the number of women recalled for additional tests. The technology produces three-dimensional views of breast tissue, allowing radiologists to better interpret images and detect cancer earlier.
A clinical model predicting hip fracture risk in postmenopausal women was developed based on 11 clinical factors. The model was validated using data from the Women's Health Initiative and showed accuracy in stratifying risk among various ethnic backgrounds.
Multicenter trials show CT angiography highly accurate in detecting coronary artery disease with sensitivity of 85% and specificity of 90%. The noninvasive exam was equal in accuracy to invasive angiography in identifying patients to be referred for angioplasty or bypass surgery.
LymphoStat-B achieved a sustained improvement in disease activity across multiple clinical measures and decreased the frequency of disease flares over time. The study also showed that LymphoStat-B was well-tolerated through 2.5 years on treatment, with comparable incidence rates of adverse events to placebo.
The Phase 2b trial shows that Albuferon significantly reduces missed work days and improves health-related quality of life compared to peginterferon alfa-2a. Patients in the Albuferon treatment groups reported fewer days of missed work and less impairment of physical and mental health.
The Phase 2b study demonstrated that Albuferon achieved at least comparable efficacy and safety to peginterferon alfa-2a with a dosing regimen requiring half as many injections. Additionally, Albuferon showed less impairment of health-related quality of life on treatment.
Dr. Paul K. Whelton has been awarded the American Heart Association's Population Research Prize for his pioneering work in documenting the burden of cardiovascular diseases. His research has provided vital data on hypertension and its impact on populations worldwide.
An education program for African-Americans showed significant improvement in cancer knowledge and attitudes, with 36% of participants demonstrating better understanding after four months. Younger participants showed greater improvement than older adults, highlighting the crucial role of education in addressing cancer disparities.
Patients given human atrial natriuretic peptide (ANP) after a heart attack have lower infarct sizes, fewer reperfusion injuries, and better outcomes than control group patients. ANP also increases left ventricle ejection fraction post-heart-attack.
A Phase II trial of a new combination therapy for patients with platinum-resistant ovarian cancer showed a 33% overall response rate, twice as high as traditional chemotherapy regimens. The therapy combines flavopiridol and cisplatin and is promising for developing more effective treatments for this disease.
Two carotid stenting trials, CAPTURE 2 and EXACT, demonstrated 30-day patient outcome results consistent with longstanding AHA guidelines for asymptomatic patients. The studies showed that carotid stenting achieved outcomes comparable to surgery in a population of high-risk patients.
A two-year study involving 321 patients found that endobronchial valves significantly improved measures of lung function and quality of life for emphysema patients. The valves allowed over-distended air sacs to deflate, resulting in increased overall lung function.
Rutgers University's New Jersey Center for Biomaterials has developed a groundbreaking biomaterial that is being tested in clinical trials for a new coronary stent. The material, designed to be strong, biodegradable, and radio-opaque, addresses the long-standing challenge of creating clinically useful fully degradable coronary stents.
A double-blind trial of 214 African infants tested the safety and efficacy of a malaria vaccine, showing no serious adverse events and a 65% reduction in new malaria infections compared to previous trials. The study provides evidence of a strong association between vaccine-induced antibodies and reduced risk of infection.
Researchers found a significant drop in blood pressure during the sleep trial, but not during resting or standing trials. This reduction occurred mostly after lights out, just before falling asleep, and may explain the lower cardiovascular mortality associated with siesta-taking.
The Phase I/II trial tested Lovaxin C in stage IVb cervical cancer patients, with symptoms including flu-like syndrome, fever, chills, nausea, and vomiting. The study found that five patients experienced tumor reductions or complete disappearance of tumors, while seven patients remained stable, and one patient achieved a partial response.
A low-fat diet was associated with a reduced risk of ovarian cancer in postmenopausal women, with the greatest reduction seen in those with high fat intake before the study. The findings suggest that a low-fat dietary pattern may be beneficial in reducing cancer incidence rates.
Researchers found that a low-fat dietary pattern reduced the risk of ovarian cancer by 40% in healthy postmenopausal women. The study followed 48,835 women for an average of 8.1 years and found no effect during the first four years due to the slow development of preventive benefits.
A $11.5 million clinical trial is examining the effectiveness of induced hypothermia in treating brain swelling in children with severe traumatic brain injuries. The study aims to improve survival rates and outcomes for these patients.
The study found that perindopril therapy reduced aortic diameters relative to placebo in both systole and diastole in patients with MFS taking standard beta-blocker therapy. This suggests that ACE inhibitors may be a useful treatment option for Marfan syndrome patients.
A UAB research team will lead the NF Consortium, a nine-institution group studying neurofibromatosis type 1. The $5.7M grant will focus on clinical trials testing new treatments for adults and children with NF.
In the trial, three patients experienced significant partial responses to the combination treatment, with stable disease noted in several non-treated tumours. The treatment was well-tolerated, with mostly Grade 1 or 2 toxicities, and showed evidence of anti-tumour activity.
The Clinical Trials Directive has led to a stagnation in clinical trials across Europe, with non-commercial sponsors contributing less than one-fifth of newly started trials. The directive's administrative burdens and cost have also discouraged many commercial and non-commercial organizations from participating.
Researchers found a new chemotherapy regimen of irinotecan and cisplatin to be effective in treating childhood brainstem gliomas, with all six children showing significant tumor reduction. While the disease eventually progressed in three children, this is a promising breakthrough for a previously difficult-to-treat cancer.
A randomized trial found that vaginal brachytherapy significantly improves quality of life for women with endometrial cancer, reducing bowel symptoms and fatigue. Quality of life scores were higher in the brachytherapy group after six months, but did not differ at initial surgery.
The Lancet Infectious Diseases report highlights frailty selection bias and non-specific trial endpoints as reasons behind the exaggeration. Few trials have included elderly people, especially those aged at least 70 years, which accounts for three-quarters of all influenza-related deaths.
The levels of vitamin E necessary to reduce oxidative stress are far higher than those commonly used in clinical trials, according to new research. Vitamin E supplements at these levels may help prevent or treat cardiovascular disease by reducing oxidative stress and inflammation.
A new initiative aims to better understand and enhance patient participation in clinical trials. Researchers will use socio-psychological approaches to identify factors influencing patients' decisions to participate. The project has the potential to increase patient accrual rates, leading to faster development of novel treatments.
A recent study published in The Lancet has found that oral dabigatran etexilate is as effective as enoxaparin in reducing the risk of venous thromboembolism (VTE) after total hip replacement surgery. The study involved 3494 patients and found no significant difference in major bleeding rates between the two treatments.
A randomized controlled trial found that treating patients with chronic kidney disease with high doses of folic acid and B vitamins did not lower the rate of death or cardiovascular events. The study suggests that the underlying burden of disease may be too great to produce a measurable benefit from lowering homocysteine levels.
A meta-analysis of 18 studies found that vitamin D supplements may reduce the risk of death from any cause by 7% over an average six-year follow-up period. Higher blood levels of vitamin D were also associated with a lower risk of death.
Researchers have developed an anti-cancer therapy using eIF4E-specific antisense oligonucleotides (ASOs), which effectively knock down the protein's expression in human tumors. The treatment has been shown to inhibit tumor growth without compromising normal tissue function, suggesting a promising approach for cancer treatment.
A new study found that inhaling nitric oxide during liver transplantation reduces hospital stays and improves blood-clotting and liver-enzyme activity. The treatment also protects transplanted livers from cell death, promising relief for donor-organ shortages.
A new generation of implanted heart-assisting pump has shown excellent survival rates and significant improvements in patient quality of life. The device, called the HeartMate II, helped 75% of patients stay alive for at least six months or until a donor heart became available.
A pilot study by Mayo Clinic researchers found that flaxseed therapy decreased hot flashes in postmenopausal women by 50% and improved their quality of life. The study also showed improvements in mood, joint pain, and overall health.
Researchers compared on-demand and planned relaparotomy strategies for patients with severe secondary peritonitis. The study found that on-demand strategy reduced health care utilization, ICU stays, and hospital stays, while also decreasing direct medical costs.
A recent study suggests that ambulatory oxygen therapy is not beneficial for COPD patients without resting hypoxemia, contrary to routine prescribing practices. The researchers found improvements in exercise performance but no benefits in daily life or quality of life.
Patients with diabetes and acute coronary syndromes have a significantly higher risk of death at 30 days and one year compared to those without diabetes. The study found that diabetes increased the risk of death by nearly 80% at 30 days for patients with unstable angina/non-STEMI and 40% for those with STEMI.
A re-analysis of the data used in a controversial meta-analysis suggests that rosiglitazone's cardiovascular risks may not be as high as initially reported. The study finds that only prospective clinical trials can definitively establish the drug's safety.
A clinical trial is underway to assess the safety and efficacy of intravenous carbamazepine in adult patients with epilepsy. The new treatment aims to provide an alternative to oral therapy during hospitalization or when oral administration is not feasible.
The Mailman School of Public Health has been awarded a $23 million grant to lead a network evaluating cardiac interventions. The network, which includes NewYork-Presbyterian Hospital/Columbia University Medical Center, aims to assess the safety and efficacy of novel diagnostic and therapeutic interventions in cardiac surgery.