Archive for the ‘Clinical Trials / Drug Trials’ Category
March 25, 2010
Filed Under (Cardiovascular / Cardiology, Clinical Trials / Drug Trials, Hypertension, Preventive Medicine) by Aashi
Patients admitted to intensive heart care with chest pains have a better chance of surviving if they have high blood pressure. This is shown in a study by scientists at Linköping University in Sweden published in the world’s largest medical journal JAMA. High blood pressure is usually associated with poor prognoses in heart disease. But that means blood pressure monitored at rest. The new findings show that it is important to factor in the situation in which the blood pressure is measured. The study, by researchers Ulf Stenestrand, Fredrik Nyström, Magnus Wijkman, and Mats Fredriksson of Linköping University, comprised 119,151 patients admitted to intensive heart care for acute chest pain between 1997 and 2007. The data was retrieved from RIKS-HIA, a register that covers all Swedish intensive heart care units. The blood pressure first measured upon admission was related to the risk of the patient dying during the care period or within a year. It turned out that the higher the upper, systolic, pressure was, the lower was the risk of dying. Among patients who had more than 162 mm Hg, the fatality risk was 22 percent lower than for those in the interval 128-144. The latter in turn ran a 40-percent lower risk of dying than those whose systolic blood pressure was under 128 mm Hg. “The really big news in the study is that the risk continued to decline at even higher levels, all the way up to 200 mm Hg, after which the reduction in risk leveled off,” says Fredrik Nyström, professor of internal medicine. The differences between the various groups were even clearer when the researchers examined the patients’ risk of dying only from cardiovascular disease. The improved prognosis was also valid for high-risk groups, such as diabetics, smokers, and obese patients. It was previously known that low blood pressure can be associated with poor prognoses for certain types of heart disease, but in those cases the low blood pressure was caused by heart failure.
March 25, 2010
Despite the aches and pains that occur in old age, many older adults maintain a positive outlook, remembering the positive experiences from their past. A new study, reported in the April 2010 issue of Elsevier’s Cortex, reveals that older adults’ ability to remember the past through a positive lens is linked to the way in which the brain processes emotional content. In the older adult brain, there are strong connections between those regions that process emotions and those known to be important for successful formation of memories, particularly when processing positive information. Dr Donna Rose Addis from the University of Auckland, together with a team of researchers supervised by Dr. Elizabeth A. Kensinger of Boston College (Chestnut Hill, MA), asked young adults (ages 19-31) and older adults (ages 61-80) to view a series of photographs with positive and negative themes, such as a victorious skier or a wounded soldier. While participants viewed these images, a functional magnetic resonance imaging (fMRI) scan recorded the brain activity across a number of different regions. When participants had completed the fMRI scan, they were asked to remember as many of the photographs as they could. Analyses revealed that aging did not affect the connectivity among regions engaged during memory formation for negative photographs. However, age differences did arise during the creation of memories for positive photographs. In older adult brains, two regions that are linked to the processing of emotional content the ventromedial prefrontal cortex (a region located just behind the bridge of the nose) and the amygdala (a region embedded in the tissue between the ears) were strongly connected to regions that are linked to memory formation. In young adults, there was not a strong connection between the emotion-processing regions and the memory-creation regions. These findings suggest that older adults remember the good times well, because the brain regions that control the processing of emotions act in concert with those that control the processing of memory, when older adults experience positive events. Young adults lack these strong connections, making it harder for them to remember positive experiences over the long term.
March 13, 2010
Many women live with breast cancer that does not respond to standard medical treatment, a condition that researchers at the Virginia G. Piper Cancer Center at Scottsdale Healthcare want to change by aggressively targeting specific genes. Improving quality of life and potentially keeping the cancer under control for a longer period of time are goals of a new clinical trial at the cancer center’s TGen Clinical Research Services, a partnership of Scottsdale Healthcare and the Translational Genomics Research Institute (TGen). The pilot study is supported by the Side-Out Foundation, a group founded by volleyball enthusiasts to help wage war on breast cancer. Women or men with advanced breast cancer that has progressed through three prior treatments are eligible for the trial, available in the western U.S. only at Scottsdale Healthcare’s Virginia G. Piper Cancer Center. “Many are living with refractory, or advanced, breast cancer that has not responded or continues to grow despite standard treatments,” explains Nurse Practitioner Gayle Jameson, principal investigator. “What we are offering here is a whole new approach for treating patients with refractory breast cancer.” Biopsied tissue will be analyzed for unique characteristics and abnormal genes in cancer cells, which are then targeted for treatment with FDA-approved anticancer medications. “We may discover that a tumor has a gene mutation that responds to a drug not typically used in a ‘one-size-fits-all’ approach,” explains Jameson. “What we are doing here is precisely matching a treatment to a specific type of cancer cell mutation and abnormal protein signaling pathways that may activate cancer cell growth. The patient would then be treated with one or more medications based on the information provided by the analyses.” Researchers call the Side-Out study the “next generation of breast cancer treatment,” expanding on what was learned about molecular profiling in an earlier clinical trial at the Virginia G. Piper Cancer Center. The new study, managed by TGen Drug Development (TD2), is open to a total of 25 patients at only two sites, the Virginia G. Piper Cancer Center at Scottsdale Healthcare and Fairfax Northern Virginia Hematology Oncology. Results of the earlier trial, known as the Bisgrove Study, showed that molecular profiling can identify specific treatments that help keep cancer in check for significantly longer periods, and in some cases even shrinking tumors. Clinical trials at the cancer center are administered by the Scottsdale Healthcare Research Institute.
March 10, 2010
A new randomized trial shows that on average, three months after receiving a series of 10 massage sessions, patients had half the symptoms of anxiety. This improvement resembles that previously reported with psychotherapy, medications, or both. But the trial, published in the journal Depression and Anxiety, also found massage to be no more effective than simple relaxation in a room alone with soft, soothing music. “We were surprised to find that the benefits of massage were no greater than those of the same number of sessions of ‘thermotherapy’ or listening to relaxing music,” said Karen J. Sherman, PhD, MPH, a senior investigator at Group Health Research Institute. “This suggests that the benefits of massage may be due to a generalized relaxation response.” Massage therapy is among the most popular complementary and alternative medical (CAM) treatments for anxiety, she added. But this is the first rigorous trial to assess how effective massage is for patients with generalized anxiety disorder. The trial randomly assigned 68 Group Health patients with generalized anxiety disorder to 10 one-hour sessions in pleasant, relaxing environments, each presided over by a licensed massage therapists who delivered either massage or one of two control treatments: * Relaxation therapy: breathing deeply while lying down * Thermotherapy: having arms and legs wrapped intermittently with heating pads and warm towels All three treatments were provided while lying down on a massage table in a softly lighted room with quiet music. All participants received a handout on practicing deep breathing daily at home. Unlike the two control treatments, massage was specifically designed to enhance the function of the parasympathetic nervous system and relieve symptoms of anxiety including muscle tension. Using a standard rating scale in interviews, the researchers asked the patients about the psychological and physical effects of their anxiety right after the 12-week treatment period ended and three months later, Dr. Sherman said. All three of the groups reported that their symptoms of anxiety had decreased by about 40 percent by the end of treatment – and by about 50 percent three months later. In addition to the decline in anxiety, the patients also reported fewer symptoms of depression and less worry and disability. The research team detected no differences among the three groups; but the trial did not include a control group that got no treatment at all. “Treatment in a relaxing room is much less expensive than the other treatments (massage or thermotherapy), so it might be the most cost-effective option for people with generalized anxiety disorder who want to try a relaxation-oriented complementary medicine therapy,” Dr. Sherman said.
March 04, 2010
Filed Under (Clinical Trials / Drug Trials, Neurology / Neuroscience, Parkinson's Disease, Psychology/psychiatry) by Aashi
Scientists are beginning to find out why people with Parkinson’s disease often feel socially awkward. Parkinson’s patients find it harder to recognize expressions of emotion in other people’s faces and voices, report two studies published by the American Psychological Association. One of the studies raises questions about how deep brain stimulation, the best available treatment for patients who no longer respond to medication, more strongly affects the recognition of fear and sadness. A neurodegenerative disorder, Parkinson’s causes tremors, stiffness and balance problems, as well as fairly frequent depression and dementia. In the March issue of Neuropsychology, Heather Gray, PhD, and Linda Tickle-Degnen, PhD, report that people with Parkinson’s disease, compared with matched controls, often have difficulty discerning how others are feeling. Their meta-analysis of 34 different studies using data from 1,295 participants shows a robust link between Parkinson’s and specific deficits in recognizing emotions, especially negative emotions, across different types of stimuli and tasks. The meta-analysis, conducted at Harvard Medical School and Tufts University, found that patients typically had some degree of problem identifying emotion from faces and voices. Further clarification is provided in a second study that showed that deep-brain stimulation, compared with medication, caused a consistently large deficit in the recognition of fear and sadness two key facial expressions that, when understood, aid survival. That study is published in the January issue of Neuropsychology. Researchers led by Julie Péron, PhD, at the Centre Hospitalier Universitaire de Rennes in France, compared the ability of people with Parkinson’s in three different groups to recognize facial emotions: 24 advanced patients implanted with deep-brain stimulators after they didn’t respond or were sensitive to oral levodopa (the usual drug for the disease); 20 advanced patients given apomorphine hydrochloride by injection or infusion pump while they waited an implant; and 30 healthy controls. Researchers tested all participants using standard photographs of facial expression before and three months after they were treated. Before implantation of the stimulators, all participants read facial expressions equally well. Patients in the surgical group were implanted with stimulators, electrical devices that prod the brain’s subthalamic nucleus, a small, lens-shaped structure, to normalize the nerve signals that control movement. This nucleus is part of the basal ganglia system, which is thought to integrate movement, cognition and emotion. Three months after treatment, only the patients with stimulators not the drug-treated patients or the healthy controls were significantly worse at recognizing fear and sadness. Patients with stimulators confused those expressions with others, such as surprise, or even no emotion. Medicated patients and healthy controls were either accurate about fear and sadness or occasionally mistook them for other negative emotions, such as disgust. “Having Parkinson’s predisposes an individual to errors in emotion recognition,” said Gray. “The research in France, along with previous studies, indicates that deep-brain stimulation produces an even more severe deficit.” Why would treating a movement disorder affect the perception of emotions? Implants affect a part of the brain that reaches across functions, so the authors suggested that the same electrical stimulation that calms over-excited motor activity may also somehow inhibit emotional processing. Although the impact of Parkinson’s and deep-brain stimulation varies by patient, it’s important to understand. “The first step is to educate patients and their close associates about the potential for emotion recognition difficulties, so they can learn to manage some of the social consequences, such as misunderstanding and frustration,” said Gray and Tickle-Degnen. The next step might be training in emotion recognition, which they said has shown promise.
March 04, 2010
This study shows that cognitive behavioural therapy (CBT) is effective in dealing with patients suffering from lupus and high levels of daily stress as it significantly reduces the incidence of psychological disorders associated with lupus and improves and maintains patients’ QOL, despite there being no significant reduction in the disease activity index. A study that is published in the current issue of Psychotherapy and Psychosomatics by a group of Spanish investigators addresses the role of cognitive behavioral treatment in systemic lupus erythematosus. Chronic stress worsens the quality of life (QOL) of lupus patients by affecting their physical and psychological status. The effectiveness of a cognitive-behavioural intervention in a group of patients with lupus and high levels of daily stress was investigated. Forty-five patients with lupus and high levels of daily stress were randomly assigned to a control group (CG) or a therapy group (TG); they received cognitive behavioural therapy (CBT) which consisted of ten consecutive weekly sessions. The following variables were evaluated at baseline and at 3, 9 and 15 months: (1) stress, anxiety, depression, (2) Systemic Lupus Erythematosus Disease Activity Index, somatic symptoms, number of flares, (3) anti-nDNA antibodies, complement fractions C3 and C4 and (4) QOL. A multivariate analysis of repeated measures and various analyses of variance were carried out. The investigators found a significant reduction in the level of depression, anxiety and daily stress in the TG compared to the CG and a significant improvement in QOL and somatic symptoms in the TG throughout the entire follow-up period. They did not find any significant changes in the immunological parameters. CBT is effective in dealing with patients suffering from lupus and high levels of daily stress as it significantly reduces the incidence of psychological disorders associated with lupus and improves and maintains patients’ QOL, despite there being no significant reduction in the disease activity index.
March 02, 2010
Filed Under (Clinical Trials / Drug Trials, Neurology / Neuroscience, Stroke, Women's Health / Gynecology) by Aashi
New research shows women who don’t receive a clot-busting drug after a stroke fare worse than men who are not treated. The study is published in the March 2, 2010, print issue of Neurology®, the medical journal of the American Academy of Neurology. “Women need to be treated for stroke as soon as possible,” said study author Michael D. Hill, MD, MSc, FRCPC, with the University of Calgary in Alberta, Canada. “We found that women who weren’t treated had a worse quality of life after stroke than men. However, the good news is that women who were treated responded just as well as men to the treatment.” For the study, scientists examined information from a stroke database on 2,113 people who had experienced a stroke. Of those, 232 were treated with the clot-busting drug known as tissue plasminogen activator (tPA) and 44 percent were women. Men and women were separately placed in groups based on whether they received tPA within three hours after their stroke. After six months, the people were interviewed by phone about their ability to function and quality of life. The study found that women who did not receive the clot-busting drug were 12 percent less likely than men to have a good outcome six months later, or 58 percent of the women compared to 70 percent of men. However, women who were treated with these medications fared about the same as men who took the clot-buster drug. “There could be many reasons why women who weren’t treated with the clot-busting drug fared worse than men, including biological reasons,” said Hill. “One social reason may be that more than 30 percent of women were widowed compared to seven percent of men at the time of stroke, and therefore did not have a spouse who could act as a caregiver. Also, post-stroke depression is more common in women than in men, which slows down recovery.”
January 20, 2010
Filed Under (Clinical Trials / Drug Trials, Parkinson's Disease, Rehabilitation / Physical Therapy) by Aashi
Treadmill training can be used to help people with Parkinson’s disease achieve better walking movements, say researchers. In a systematic review of the evidence, Cochrane Researchers concluded treadmill training could be used to improve specific gait parameters in Parkinson’s patients. Gait hypokinesia, characterised by slowness of movement, is one of the main movement disorders that affects Parkinson’s patients and can have a major impact on quality of life. More recently, health professionals have started incorporating exercise into treatment regimes as a useful complement to traditional drug therapies. Training on treadmills is one option that may help to improve movement. The researchers analysed data from eight trials including 203 patients for the review, published in The Cochrane Library. They compared treadmill training versus no treadmill training, using effects on walking speed, stride length, number of steps per minute (cadence) and walking distance to measure improvement in gait. Treadmill training had a positive impact on each of these measurements, apart from cadence. “Treadmill training appears to be a safe and effective way of improving gait in patients with Parkinson’s disease,” said lead researcher Jan Mehrholz, of the Wissenschaftliches Institut in Kreischa, Germany. “Crucially, we saw very few adverse effects or drop outs in patients given this type of rehabilitation therapy.” However, the researchers say the findings must be treated with care as they are based on a limited number of small trials. “There is still a need for larger trials to establish if treadmill training can be safely used as a routine therapy for Parkinson’s patients,” said Merhholz. “We also need to answer basic questions about how long the benefits last and what a good training programme should consist of. For instance, how often and how long should patients train for?”
January 20, 2010
Filed Under (Clinical Trials / Drug Trials, HIV / AIDS) by Aashi
Intensive home-based nursing in HIV/AIDS patients significantly improves self-reported knowledge of HIV, awareness of medications, and self-reported adherence to medication programmes, according to a new Cochrane Systematic Review. One home-based care trial included in the review also significantly impacted on HIV stigma, worry, and physical functioning. It did not, however, help improve depressive symptoms, mood, general health, and overall functioning. These conclusions are interesting, but more research is needed to understand the impact of home-based care in developing countries and on important disease outcomes, say the researchers. The study represents the first systematic review of the impact of home care in HIV/AIDS. As a disease that affects 33 million people, HIV/AIDS puts a huge strain on health systems, particularly in developing countries. Therefore, in countries where health services are overstretched, home-based care is offered to HIV patients as an alternative to hospital care. Home-based care can include counselling, medical management, exercise, and spiritual support to try to improve patients’ quality of life in familiar surroundings, while reducing costs and pressure on hospital beds. Researchers examined data from 13 studies, two of which were ongoing. The researchers report that home-based care has positive impacts on some aspects of patient wellbeing but little effect on others. Patients said that home care improved their knowledge of the disease, and of HIV medications, and helped them adhere to medication programmes. It also reduced worry and improved physical functions of patients, but had little effect on depression, general health, or indicators of disease progression such as CD4 counts. Importantly, few studies considered the effects of home-based care in developing countries or on important disease outcomes. “Further large studies are needed to evaluate the effects of home-based care in developing countries, where HIV and AIDS take the biggest toll,” said Young. “And there should be a greater focus on how home-based care impacts on progression to full blown AIDS and death from the disease.” “This study is a useful addition to the literature because of the wide range of home care options considered. However, there is no doubt that the evidence base for home-based care in HIV needs further development.”
January 19, 2010
A randomised controlled trial of fish oil given intravenously to patients in intensive care has found that it improves gas exchange, reduces inflammatory chemicals and results in a shorter length of hospital stay. Researchers writing in BioMed Central’s open access journal Critical Care investigated the effects of including fish oil in the normal nutrient solution for patients with sepsis, finding a significant series of benefits. Philip Calder, from the University of Southampton, UK, worked with a team of researchers to carry out the study in 23 patients with systemic inflammatory response syndrome or sepsis in the Hospital Padre Américo, Portugal. He said, “Recently there has been increased interest in the fat and oil component of vein-delivered nutrition, with the realization that it not only supplies energy and essential building blocks, but may also provide bioactive fatty acids. Traditional solutions use soybean oil, which does not contain the omega-3 fatty acids contained in fish oil that act to reduce inflammatory responses. In fact, soybean oil is rich in omega-6 acids that may actually promote inflammation in an excessive or unbalanced supply”. Calder and his colleagues found that the 13 patients in the fish oil group had lower levels of inflammatory agents in their blood, were able to achieve better lung function and left hospital earlier than the 10 patients who received traditional nutrition. According to Calder, “This is the first study of this particular fish oil solution in septic patients in the ICU. The positive results are important since they indicate that the use of such an emulsion in this group of patients will improve clinical outcomes, in comparison with the standard mix”. |
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