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    News and Articles on Randomized

    Archives: Randomized

    ELAD(R) Liver Support System Study Initiated at Multiple U.S. Centers  Jan 7, 2009
    SAN DIEGO, Jan. 7 /PRNewswire/ -- Vital Therapies, Inc. (VTI), a development stage company targeting liver disease, today announced patient enrollment has begun for a randomized, controlled, multi-center, Phase 2 clinical trial that will study the Extracorporeal Liver Assist Device (ELAD) as a treatment for patients with Acute Liver Failure (ALF) under three protocols ... This trial expands on prior results from phase 1 and 2 U.S. and U.K. trials and a pivotal, randomized, controlled clinical... (PR Newswire)

    Parkinson's treatment shows promise in patients, study says  Jan 7, 2009
    It is a widely accepted treatment for advanced Parkinson's disease, but few randomized trials have been conducted comparing different treatments. Previous studies also have largely excluded older patients, who account for the majority of those with the disease. (Chicago Tribune)

    Deep brain stimulation for Parkinson's brings bad with good  Jan 7, 2009
    The largest randomized clinical trial of its kind to date included 255 people who were in the advanced stages of Parkinson's. About half the participants had surgery for deep brain stimulation, and half were given the best non-surgical therapy available, including drugs and physical therapy. (USA Today)

    Q&A:  Which studies should we listen to?  Jan 7, 2009
    A. The strongest studies are called randomized clinical trials ... Q. Are all diet studies randomized trials. (USA Today)

    NO help: Nitric oxide monitoring does not help most children with asthma  Jan 7, 2009
    D., at the Erasmus University Medical Center-Sophia Children's Hospital in the Netherlands, and colleagues randomized 151 children from 15 academic centers and hospitals with mild to moderate asthma to a 30-week monitoring course. Families were called every three weeks and reported on the daily symptoms in the prior three weeks. (EurekAlert!)

    YM BIOSCIENCES RECEIVES CLEARANCE TO INITIATE RANDOMIZED DOUBLE-BLIND CLINICAL TRIALS OF NIMOTUZUMAB IN LUNG CANCER AND BRAIN METASTASES FROM LUNG CANCER  Jan 6, 2009
    MISSISSAUGA, ON, Jan. 5 /PRNewswire-FirstCall/ - YM BioSciences Inc. (NYSE Alternext US:YMI, TSX:YM, AIM:YMBA), an oncology company that identifies, develops and commercializes differentiated products for patients worldwide, today announced that it has received clearance from Canadian regulatory authorities to initiate two Phase II, double-blind, randomized trials for nimotuzumab, its EGFR-targeting antibody, in combination with radiation-based treatments ... "Conducting randomized, controlled... (PR Newswire)

    Low-carb diets prove better at controlling type 2 diabetes  Jan 6, 2009
    Eight-four volunteers with obesity and type 2 diabetes were randomized to either a low-carbohydrate ketogenic diet (less than 20 grams of carbs/day) or a low-glycemic, reduced calorie diet (500 calories/day). Both groups attended group meetings, had nutritional supplementation and an exercise regimen. (EurekAlert!)

    YM BIOSCIENCES' NIMOTUZUMAB SELECTED FOR MULTINATIONAL PHASE III TRIAL BY NATIONAL CANCER CENTRE OF SINGAPORE  Jan 5, 2009
    However, what is likely to set nimotuzumab apart is its low toxicity and favourable safety profile," said Dr. Rikrik Ilyas, Director of IGK. "Patients are spared the discomfort of severe skin rashes and may benefit from an enhanced quality of life. Both patients and physicians may also benefit from lack of hypomagnesemia often related to treatment with other anti-EGFR targeted drugs. (Canada Newswire)

    Discovery Labs' Surfaxin(r) Phase 2 BPD Clinical Trial Results Published in Pediatrics  Jan 5, 2009
    A Pilot Randomized, Controlled Trial of Later Treatment with a Peptide-Containing, Synthetic Surfactant for the Prevention of Bronchopulmonary Dysplasia (Laughon et al. Pediatrics 2009;123 89-96) ... Discovery Labs conducted a Phase 2 clinical trial to evaluate the safety and potential efficacy of Surfaxin in infants at risk for BPD. The clinical trial enrolled 136 premature infants that were randomized to receive, in addition to standard of care, either Surfaxin standard dose (175 mg/kg),... (Primezone Releases)

    Cranberry as Effective as Antibiotics for UTIs  Jan 5, 2009
    The randomized controlled clinical trial included 137 women who had been treated with antibiotics for a urinary tract infection at least twice in the previous twelve months. Half the group received 100 mg of trimenthoprim for six months and the other half 500 mg of Cran-Max, a cranberry concentrate. (Newsmax)

    Preventing weight gain: the baseline weight related behaviors and delivery of a randomized controlled intervention in community based women.  Jan 4, 2009
    Preventing weight gain: the baseline weight related behaviors and delivery of a randomized controlled intervention in community based women ... The recruitment and delivery of the cluster-randomized controlled intervention was in conjunction with 12 primary (elementary) schools ... Two hundred and fifty community based women were randomized as clusters to intervention (n=127) or control (n=123). (BioMed Central)

    Long-term use of a hypertension drug may reduce symptoms of heart ...  Jan 2, 2009
    Research team led by Dr. Jiri Krupicka of Na Homolce Hospital in Prague, the Czech Republic conducted a double-blind, placebo-controlled, randomized study to the effect of the long-term administration of candesartan - marketed by AstraZeneca and Takeda as Atacand and BioPress respectively - on patients with Hypertrophic cardiomyopathy (HCM). Generally people with hypertrophic cardiomyopathy display mild symptoms or are completely asymptomatic, up to 1 percent of affected people succumb to sudden... (TopNews)

    Study Shows Machine Perfusion Significantly Improves Transplant Results  Jan 1, 2009
    This is the first randomized, prospective study to directly compare the two methods of storing and transporting organs for transplantation. "For the first time in the United States, the number of those waiting for a life-saving transplant has passed 100,000," said Joseph Vassalotti, MD, Chief Medical Officer of the National Kidney Foundation. (PR Newswire)

    Giant Osteoclasts and Alendronate  Jan 1, 2009
    Methods We examined 51 bone-biopsy specimens obtained after a 3-year, double-blind, randomized, placebo-controlled, dose-ranging trial of oral alendronate to prevent bone resorption among healthy postmenopausal women 40 through 59 years of age. The patients were assigned to one of five groups: those receiving placebo for 3 years; alendronate at a dose of 1, 5, or 10 mg per day for 3 years; or alendronate at a dose of 20 mg per day for 2 years, followed by placebo for 1 year. (New England Journal of Medicine)

    Machine Perfusion or Cold Storage in Deceased-Donor Kidney Transplantation  Jan 1, 2009
    Methods In this international randomized, controlled trial, we randomly assigned one kidney from 336 consecutive deceased donors to machine perfusion and the other to cold storage. All 672 recipients were followed for 1 year. (New England Journal of Medicine)

    Arousal frequency in heart failure found to be a unique sleep problem  Jan 1, 2009
    Data were analyzed from 205 heart failure patients with CSA who were enrolled in the Canadian Continuous Positive Airway Pressure for Patients with Central Sleep Apnea and Heart Failure trial, a prospective, randomized, multicenter clinical trial. Participants were between 18 and 79 years of age, and they were randomly assigned to a CPAP treatment group (97 members) or a control group (108 members). (EurekAlert!)

    Anti-fungal Drug Offers Great Benefits To Some With Severe Asthma, Study Suggests  Dec 31, 2008
    In the prospective double-blind study, 58 patients with severe asthma and allergic sensitivity to at least one of seven different common fungi (confirmed by a skin-prick test and/or an IgE blood test for the study) were randomized to receive either an oral dose of itraconazole (200mg twice a day) or a placebo. After 32 weeks of treatment, 18 of the 29 patients (62 percent) who were randomized to receive the drug experienced significant improvements on their Asthma Quality of Life Questionnaires,... (Science Daily)

    Breast Cancer: Diet High In Vegetables, Fruit And Fiber May Cut Risk Of Cancer Recurrence In Women Without Hot Flashes  Dec 31, 2008
    About one-half (447) of the "no hot flashes" group were randomized to the special, "intervention" high-vegetable fruit diet while the other half (453) was given the generally recommended diet of five servings of fruits and vegetables a day. The team found that those on the intervention diet had a significantly lower rate of a second breast cancer event (16. (Science Daily)

    GTx submits toremifene 80 mg to FDA  Dec 31, 2008
    The company s U.S. submission is supported by the results of a two-year, double-blind, placebo-controlled, randomized Phase III clinical trial of 1,382 men with advanced prostate cancer on ADT. Toremifene 80 mg met the primary endpoint of the clinical trial and other key secondary endpoints related to estrogen deficiency side effects of ADT. Toremifene has been marketed for the treatment of advanced breast cancer in more than 60 countries including the U.S.. GTx is a biopharmaceutical company... (Memphis Business Journal, TN)

    Hypertension drug to reduce genetic heart disease  Dec 31, 2008
    For the study, the researchers conducted a double-blind, placebo-controlled, randomized study on the long-term administration of candesartan in patients with HCM.. They found that candesartan reduced the symptoms of HCM, including decreasing the thickening of the left ventricle. (Times of India)

    Vitamins C and E and beta carotene again fail to reduce cancer risk in randomized controlled trial  Dec 31, 2008
    Women who took beta carotene or vitamin C or E or a combination of the supplements had a similar risk of cancer as women who did not take the supplements, according to data from a randomized controlled trial in the December 30 online issue of the Journal of the National Cancer Institute ... Results from randomized trials that address the issue, however, have been inconsistent and have rarely supported that observation ... D., of the Brigham and Women's Hospital and Harvard Medical School in... (EurekAlert!)

    Is bismuth a safe medicine for the treatment peptic ulcer disease?  Dec 31, 2008
    They examined the risk of adverse events in randomized controlled trials using bismuth compounds as part of H. pylori eradication therapy compared to other regimens. Thirty-five randomized controlled trials containing over 4500 patients were identified comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or in combination with acid suppression. (EurekAlert!)

    New Drug for Insomnia After Sleep-T...  Dec 30, 2008
    Santha Rajaratnam and Elizabeth Klerman, from the Vanda Pharmaceuticals Inc. and Harvard Medical School, reported in December 2nd, 2008 in a study entitled Melatonin agonist Tasimelteon (VEC-162) for transient insomnia after sleep-time: two randomized controlled multicentre trials (The Lancet, vol8, pp61812-61817, 2008) the efficacy of Tamisimelteon to treat circadian disorders due to time shift. Tasimelteon, VEC-162, May Treat Insomnia Caused by Jet Lag. (Suite101.com)

    Diet For Diabetics: Low-glycemic Diet Shows Greater Improvement In Glycemic Control Than High-fiber Diet  Dec 30, 2008
    Effect of a Low-Glycemic Index or a High-Cereal Fiber Diet on Type 2 Diabetes: A Randomized Trial. JAMA, 2008;300(23):2742-2753. (Science Daily)

    Surgery lets man walk away from potential paralysis  Dec 30, 2008
    But a randomized trial some patients will get the drug and others won't is required before doctors know if it really works. Dr. Fehlings is also pushing for a world first an experiment to see whether stem cells can rebuild damaged human spines. (Globe and Mail)

    What Will '09 Bring In Medicine?  Dec 30, 2008
    But a new study raises hopes for a one-day treatment known as "intraoperative electron beam radiation therapy," or IOERT. One researcher has shared the findings of an eight-year randomized trial. The results showed that women who received breast-conserving surgery followed by a single dose of IOERT at the time of surgery had a chance of survival equal to that of women who underwent the surgery followed by six weeks of postoperative radiation therapy. (CBS News -- Early Show)

    Anti-fungal drug may treat asthma  Dec 30, 2008
    The results showed that 62% of the patients who were randomized to receive the drug experienced significant improvements on their Asthma Quality of Life Questionnaires, and in runny nose and morning lung function. However, 11 of the patients who received the drug left the trial before completion, some citing side effects that included nausea, breathlessness and muscle weakness. (Times of India)

    Safe new therapy for genetic heart disease  Dec 30, 2008
    The related report by Penicka et al, "The effects of candesartan on left ventricular hypertrophy and function in non-obstructive hypertrophic cardiomyopathy: a pilot, randomized study," appears in the January issue of The Journal of Molecular Diagnostics ... Researchers lead by Dr. Jiri Krupicka of Na Homolce Hospital, Prague conducted a double-blind, placebo-controlled, randomized study on the long-term administration of candesartan in patients with HCM. Dr. Krupicka's group found that... (EurekAlert!)

    Can Amphetamines Help Cure Cocaine Addiction?  Dec 30, 2008
    "In our research, we were able to separate out the more and less severely addicted patients , and the more severe people were more responsive to the more potent stimulants," says Grabowski, who has conducted two randomized controlled trials involving nearly 200 patients, which found that dexamphetamine treatment reduced cocaine use better than a placebo. Proponents of stimulant maintenance treatment also note this significant detail: Many stimulant abusers suffer from... (Time.com)

    Cognitive Behavioral Therapy and Sertraline in Childhood Anxiety  Dec 27, 2008
    Methods In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety... (New England Journal of Medicine)

    Best Approach to Episiotomy Unclear  Dec 26, 2008
    To compare the two strategies, they randomized 200 women who required operative vaginal delivery to routine or restrictive use of episiotomy. There were no striking outcome differences between the routine or restrictive groups. (MEDLINEplus)

    FDA Approves Ferring Pharmaceuticals' Degarelix (Generic Name) for Treatment of Advanced Prostate Cancer  Dec 25, 2008
    The 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelix compared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous (under the skin) injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intermuscular (into the muscle) injections of... (PR Newswire)

    Memory Pharmaceuticals Initiates Biomarker Study of R3487/MEM 3454 in Schizophrenia  Dec 25, 2008
    Subjects will be randomized to receive R3487/MEM 3454 and placebo in a 5-way cross-over design. Each subject will participate in 5 treatment periods. (PR Newswire)

    Sexploration: Lingering grief may curb his ardor  Dec 25, 2008
    Last month, in the Journal of Sexual Medicine, a Brazilian team analyzed available literature and found that men randomized to receive psychotherapy plus sildenafil (Viagra) showed significant improvement of ED.. So yes, your man ought to visit a urologist and ask that urologist if, perhaps, some form of counseling might be in order. (MSNBC -- Health)

    Cancer: Tamoxifen's Power Comes From Endoxifen  Dec 25, 2008
    (May 4, 2007) Women at high risk for breast cancer who have undergone a hysterectomy appear to benefit from taking tamoxifen to prevent breast cancer, according to an extended follow-up of the Italian Randomized. (Dec. (Science Daily)

    Case Western Reserve finds mechanism underlying alt. splicing of premessenger RNA into messenger RNA  Dec 25, 2008
    The research team randomized all possible combinations of nucleotides in a sequence of 12 nucleotides just downstream of the stronger splice site and in 12 just upstream of it, their exact positions chosen so that they would be as close as possible to the splice site without interfering with the very nearest nucleotides, which are required to complete the splices. This work was done both in vitro and in vivo, with similar results. (EurekAlert!)

    Paladin Labs Inc. Acquired ViRexx Medical Corp.  Dec 23, 2008
    OvaRex MAb was subject to one Phase II study examining combination chemo-immunotheray in front-line treatment, and two randomized, double blind and placebo controlled Phase III clinical trials examining immunotherapy during remission. BrevaRex MAb was shown to be safe in a Phase I clinical trial in patients with MUC-1 expressing tumours. (CCNMatthews Press Releases)

    Vitamin supplements don't fight cancer, studies show  Dec 22, 2008
    But they have puzzled over how their obvious benefits could be so elusive in randomized controlled trials, the gold standard of medical research ... Unlike observational studies, which look backward at groups of people to identify factors that are associated with a particular disease, a forward-looking randomized controlled trial has the power to show whether a particular factor can prevent the disease ... "We were all guilty of wanting to go for that home-run-style randomized trial that would... (Los Angeles Times)

    New insight into effectiveness of colonoscopy  Dec 22, 2008
    It was not a randomized, controlled trial, so it couldn't prove that colonoscopy causes a reduction in cancer deaths. Also, the researchers didn't have enough information to know for sure whether colonoscopies were for screening or diagnostic purposes. (Los Angeles Times)

    * Alcohol and the elderly  Dec 22, 2008
    There have been few randomized controlled clinical trials of alcohol use to definitively show that alcohol consumed in any amount by any group of people benefits health. That said, here is what the studies indicate. (Taipei Times, Taiwan -- World Business)

    Male Circumcision May Decrease Risk Of HPV Infection And Cervical Cancer  Dec 21, 2008
    Uncircumcised men aged 18-24 years were randomized into either an intervention group, to be circumcised, or a control group, to remain uncircumcised. During this study, urethral swab samples were collected and analyzed for presence of HPV among men followed up for 21 months. (Science Daily)

    Eldecalcitol, an Active Vitamin D3 Derivative, Reduces Incidence of New Vertebral Fractures in Osteoporosis Patients in Phase III Clinical Trial  Dec 21, 2008
    Tokyo, Dec 16, 2008 - (JCN Newswire) - Chugai Pharmaceutical Co., Ltd. and Taisho Pharmaceutical Co., Ltd. announced today that the active vitamin D3 derivative being co-developed by the two companies for treatment of osteoporosis (generic name: eldecalcitol; Chugai development code: ED-71, Taisho development code: CT-081) significantly reduced the incidence of new vertebral fractures in osteoporosis patients in a randomized, double-blind, comparative trial ... This phase III clinical trial,... (JCN Network, Japan)

    Video: Gleevec Receives US Approval as First Treatment To Reduce Risk of Cancer Returning in Patients with Gastrointestinal Stromal Tumors  Dec 20, 2008
    The FDA regulatory filing for the adjuvant GIST indication was based on data from a Phase III, double-blind, randomized, multicenter, international study of more than 700 GIST patients who had undergone surgery to remove their tumors ... Participants were randomized to receive either Gleevec 400 mg/day or a matching placebo for one year(4) ... Z9001: A Phase III Randomized Double-blind Study of Adjuvant STI571 (Glivec(R)) Versus Placebo in Patients Following the Resection of Primary... (PR Newswire)

    Toxic Poinsettias? Hangover Cures? It May Be All Fiction  Dec 20, 2008
    At least 12 double-blind, randomized, controlled trials have looked at the effect of sugar on children, and none found evidence for the sugar-equals-hyperactivity myth. In one study, children weren't even given sugar, but their parents were told they had been -- and parents who thought their children had eaten sugar rated their behavior as more hyperactive. (MEDLINEplus)

    New Psychotherapy Has Potential To Treat Majority Of Cases Of Eating Disorders  Dec 20, 2008
    19, 2008) Wellcome Trust researchers have developed a new form of psychotherapy that has been shown to have the potential to treat more than eight out of ten cases of eating disorders in adults, a study out today reports. This new "enhanced" form of cognitive behavioural therapy (CBT-E) builds on and improves the current leading treatment for bulimia nervosa as recommended by the National Institute of Health and Clinical Excellence (NICE). (Science Daily)

    AGA Medical Corporation Partners With Professional Football Player Tedy Bruschi for National Stroke Awareness Program  Dec 19, 2008
    AGA Medical is currently conducting a multicenter, randomized clinical study, known as the RESPECT trial, to investigate whether closure of a congential heart defect using an AGA Medical device is superior to current standard of care treatment in the prevention of a particular type of stroke. For more information on the clinical trial and the warning signs of stroke, visit. (PR Newswire)

    Clinical Trial Demonstrates Safety Of Pre-transplant Expansion Of Umbilical Cord Blood Stem Cells  Dec 19, 2008
    In a first-of-its-kind randomized clinical trial, researchers at The University of Texas M. D. Anderson Cancer Center are addressing the critical challenge to successful "standard" cord blood transplants for adult patients - low doses of stem cells that lead to longer recovery times, leaving patients more vulnerable to bleeding, infection and transplant failure ... The clinical trial randomized 71 patients with advanced leukemias or lymphomas into either a standard cord blood transplant, in... (Science Daily)

    Financial Incentives Appear Effective For Short-term Weight Loss  Dec 19, 2008
    Volpp et al. Financial Incentive-Based Approaches for Weight Loss: A Randomized Trial. JAMA The Journal of the American Medical Association, 2008; 300 (22): 2631 DOI. (Science Daily)

    New Papers Offer Insights Into Process Of Malarial Drug Resistance  Dec 19, 2008
    A randomized double blind trial would suggest the answer is yes. Vitamin A and zinc play a critical role in the. (Science Daily)

    Working Splints Helpful for Wrist Arthritis  Dec 18, 2008
    As Dr. Martine M. Veehof told Reuters Health, "This is the first randomized, controlled trial that reveals evidence that wrist working splints are effective in reducing wrist pain.". Veehof, at the University of Twente in Enschede, and colleagues point out that about 75 percent of patients with rheumatoid arthritis have wrist arthritis. (MEDLINEplus)

    Effectiveness of Peer-Led Sex Education Questioned  Dec 18, 2008
    The Randomized Intervention trial of Pupil-led sex Education, known as the RIPPLE trial, compared the efficacy of peer-led versus teacher-led sex education delivered to over 9000 male and female 8th grade students in the United Kingdom. Peer-led sessions, conducted by specially trained older students, focused on information similar to that offered in the teacher-led program. (MEDLINEplus)

    Implantable Monitor May Help In Managing Diastolic Heart Failure  Dec 18, 2008
    Led by Michael R. Zile, M.D., of Medical University of South Carolina, Charleston, the researchers analyzed data on DHF patients enrolled in a larger randomized trial evaluating the IHM for heart failure. The IHM is a surgically implanted device that continuously records data on heart function and other key variables. (Science Daily)

    Prostate Cancer Drug Reduces Testosterone Levels In As Little As Three Days Without Initial Hormone Surge  Dec 18, 2008
    Klotz et al. The efficacy and safety of degarelix: a 12-month, comparative, randomized, open-label, parallel-group phase III study in patients with prostate cancer. BJU International, 102, p1531-1538 (December 2008). (Science Daily)

    Alfuzosin in Chronic Prostatitis–Chronic Pelvic Pain Syndrome  Dec 18, 2008
    Background In men with chronic prostatitis chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials. Methods We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis chronic pelvic pain syndrome. (New England Journal of Medicine)

    Better patient outcomes with drug eluting stents  Dec 18, 2008
    They also caution that "despite the large amount of favourable long-term data on the use of drug eluting stents from randomized controlled trials, meta-analyses and observational studies, the long-term safety of drug eluting stents, especially regarding late and very late stent thrombosis, remains a major concern.". . (EurekAlert!)

    Study: Colonoscopies have limitations  Dec 17, 2008
    We used a case-control study method, which is not the best way (that would be a double-blind, randomized study trial). But there's no current study looking at colonoscopy in the randomized study trial right now, so it would take another 10-15 years to get results from that kind of a study if it were started today. (CNN -- Health)

    Neither Vitamin C Or E Associated With Reduced Risk Of Prostate Cancer, Or Other Cancers  Dec 17, 2008
    "However, definitive proof that vitamins E and C can reduce the risk of overall or site-specific cancers must rely on large-scale randomized trials," the authors write ... J. Michael Gaziano, M.D., M.P.H., of Brigham and Women's Hospital and VA Boston Healthcare System, Boston, and colleagues conducted the Physicians' Health Study II, a randomized, placebo-controlled trial to examine the effects of vitamin E and vitamin C on prostate cancer and total cancer ... Participants were randomized to... (Science Daily)

    Medication Used To Reduce Nausea Following Tonsillectomies Linked With Increased Risk Of Bleeding  Dec 17, 2008
    "In summary, in children undergoing tonsillectomy, dexamethasone has a significant and dose-dependent antiemetic [prevents or alleviates nausea and vomiting] effect and decreases the need for rescue analgesia with nonsteroidal anti-inflammatory drugs [NSAIDs]. However, it cannot be excluded that dexamethasone, possibly through inhibition of wound healing, increases the risk of postoperative bleeding in this specific setting. Randomized trials that are specifically designed to confirm or refute... (Science Daily)

    Half-dose Flu Shot Appears To Produce Immune Response In Young, Healthy Adults  Dec 17, 2008
    Renata J.M. Engler, M.D., of Walter Reed Army Medical Center, Washington, D.C., and colleagues conducted a randomized clinical trial involving healthy adults age 18 to 64 years. Between November and December 2004, a total of 554 adults received a full dose of trivalent inactivated influenza vaccine and 556 received a half-dose of the vaccine. (Science Daily)

    Alcohol and aging adults: Part of the problem or part of the cure?  Dec 17, 2008
    There have been few randomized controlled clinical trials of alcohol use to definitively show that alcohol consumed in any amount by any group of people benefits health. The Benefits: That said, here is what the studies indicate. (International Herald Tribune -- Health)

    Website on hospital care, cost  Dec 16, 2008
    One large, randomized clinical trial led by Dr. J. Michael Graziano of Brigham and Women's Hospital found that middle-age men who took vitamin E or vitamin C for about eight years did not lower their risk of prostate cancer or other kinds of cancer. Another large trial from the University of Texas M.D. Anderson Cancer Center studying the effect of selenium and vitamin E on cancer risk was halted early when neither supplement showed any benefits to the men taking it. (Boston Globe)

    QLT announces interim results of radical study evaluating Visudyne combination therapy  Dec 16, 2008
    Based on the six-month data review for Visudyne combination therapy and the DSMC's recommendation, the study will continue as planned (Canada Newswire)

    (Multimedia Version): Abbott Receives FDA Approval for TRILIPIX(TM) (fenofibric acid), First and Only Fibrate Indicated for Use in Combination With a Statin for Cholesterol Management  Dec 16, 2008
    The efficacy and safety of TRILIPIX in combination with the three most commonly prescribed statins -- rosuvastatin, atorvastatin and simvastatin -- was evaluated in three randomized, multicenter, double-blind, controlled, 12-week Phase III studies, totaling 2,698 patients with mixed dyslipidemia. Patients included in the studies had multiple lipid problems, with an LDL > 130 mg/dL, triglycerides > 150 mg/dL and HDL less than 40 mg/dL for men and less than 50 mg/dL for women. (PR Newswire)

    Two Endometrial Cancer Treatments May Not Work  Dec 16, 2008
    "This randomized trial has shown no evidence of a benefit for systematic lymphadenectomy for endometrial cancer in terms of overall, disease-specific, and recurrence-free survival. This study is one of the largest reported surgical gynecological cancer trials... Pelvic lymphadenectomy cannot be recommended as routine procedure for therapeutic purposes outside of clinical trials," concluded Dr. Ann Marie Swart, of the Medical Research Trials Unit in London, and colleagues. The second study... (MEDLINEplus)

    Hepatitis C Treatment Reduces The Virus But Liver Damage Continues  Dec 16, 2008
    HALT-C, a randomized multicenter trial of 1,050 patients with chronic hepatitis C who had failed prior treatment to eradicate the infection, tested whether long-term treatment with peginterferon alfa-2a would reduce the development of cirrhosis, liver cancer, or liver failure. The 517 patients randomized to the treatment arm received 90 micrograms of peginterferon in weekly injections for 3. (Science Daily)

    Radiation Before Surgery Improves Pancreatic Cancer Outcomes, Study Shows  Dec 16, 2008
    He stressed that the findings do need to be verified by a randomized, prospective trial the gold standard of medical research before any firm recommendations can be made. Dr. Sherr is hopeful that such a trial will be conducted in the future. (Science Daily)

    Toothbrushing Can Prevent Hospital-borne Pneumonia  Dec 16, 2008
    (May 21, 2008) A silver-coated endotracheal tube may reduce infections with highly resistant bacteria over traditional tubes by nearly half, according to the results of a large randomized. (Oct. (Science Daily)

    Summary for Patients  Dec 16, 2008
    Effects of Home-Based Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease: A Randomized Trial -- Maltais et al. 149 (12): 869 -- Annals of Internal Medicine ... The summary below is from the full report titled "Effects of Home-Based Pulmonary Rehabilitation in Patients with Chronic Obstructive Pulmonary Disease. A Randomized Trial." It is in the 16 December 2008 issue of Annals of Internal Medicine (volume 149, pages 869-878). (Annals of Internal Medicine)

    Regimens: Acupuncture Provides Headache Relief  Dec 16, 2008
    The report, which appears in the December issue of Anesthesia and Analgesia, reviewed 25 randomized controlled trials in adults that lasted more than four weeks. In seven trials comparing acupuncture with medication, researchers found that 62 percent of 479 patients had significant response to acupuncture, and only 45 percent to medicine. (Atlanta Journal-Constitution -- Health)

    Approval of STELARA(TM) in Canada Marks Advancement in Treatment of Moderate to Severe Plaque Psoriasis  Dec 15, 2008
    " A human monoclonal antibody, STELARA targets the activity of cytokines interleukin-12 (IL-12) and interleukin-23 (IL-23), naturally occurring proteins that are important in regulating the immune system and that are thought to be associated with some immune related inflammatory diseases including plaque psoriasis. The treatment regulates IL-12 and IL-23 interactions, reducing inflammation in the skin cells and helping to control the signs and symptoms of psoriasis.(1) Data Shows Improvements to... (Canada Newswire)

    Positive Phase II Study of Pacira's EXPAREL(TM) (DepoBupivacaine) in Hernia Repair Presented at the Postgraduate Assembly in Anesthesiology (PGA)  Dec 15, 2008
    The results of the multicenter, randomized, double-blind study were presented in a poster at the Annual Postgraduate Assembly in Anesthesiology in New York City today, by lead investigator Richard Langford, MD, FRCA, Pain and Anaesthesia Research Centre, St. Bartholomew's Hospital, London, UK. ... Subjects were randomized into one of four cohorts and intraoperatively administered either 175mg, 225mg, 300mg or 325mg of EXPAREL or 100mg bupivacaine HCL around the surgical wound by infiltration... (PR Newswire)

    Study Finds DOXIL(R) Combination Therapy Delays Disease Progression for Patients With Metastatic Breast Cancer  Dec 15, 2008
    Results from this randomized, parallel-group, open-label, multi-center study were presented today at the 31st Annual San Antonio Breast Cancer Symposium (SABCS). The study included only patients previously treated with anthracyclines who had a disease-free interval of at least one year. (PR Newswire)

    Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium  Dec 15, 2008
    On Saturday, Matthew Goetz, M.D., from Mayo Clinic and colleagues from Austria presented data examining the predictive utility of CYP2D6 and the prognostic utility of the Theros Breast Cancer Index in women with breast cancer randomized to receive five years of treatment with tamoxifen or two years of tamoxifen followed by three years anastrozole treatment. The researchers found that the Theros Breast Cancer Index will identify, among patients with early stage breast cancer, those with a higher... (PR Newswire)

    Treatment Fails To Improve Common Form Of Heart Failure, Study Finds  Dec 15, 2008
    Few drugs have been tested as treatment strategies in randomized studies of patients with diastolic heart failure largely because the condition wasn't recognized as a separate form of heart failure until the past decade. To date, no effective treatments have been found. (Science Daily)

    Letters to the Editor  Dec 15, 2008
    In the sole randomized, controlled trial conducted on this device, TMS conferred no benefit on the main measurement of depression the company had specified before the trial. This is why the Food and Drug Administration initially rejected TMS as a treatment for major depression. (Sacramento Bee -- Opinion)

    Ivivi Technologies Receives FDA 510(k) Clearance for its Latest Generation SofPulse, Roma3 and Torino II Electrotherapy Systems  Dec 15, 2008
    We are extremely pleased the FDA has thoroughly reviewed the substantial amount of data covering our family of tPEMF(tm) products, which included biophysical dosimetry studies and randomized, placebo-controlled animal and human clinical trials submitted in support of this 510(k),'' commented Steven Gluckstern, Chairman, President and Chief Executive Officer ... These signals have demonstrated reductions in patient morbidity by accelerating reduction of acute post operative pain and edema and... (Primezone Releases)

    Vitamin D may be essential for heart...  Dec 14, 2008
    Because the Framingham Heart Study is not a randomized controlled trial, it's still not clear if vitamin D is the real reason for the link (the vitamin's levels could drop in unhealthy people for other reasons), or if taking a would lower the risk. However, experts agree that a connection is likely. (CNN -- Law)

    Mayo Clinic research on tamoxifen leads to recommendation for CYP2D6 gene test  Dec 14, 2008
    The research teams examined DNA from a subset of postmenopausal women treated in the ABCSG-8 study, which previously randomized nearly 3,900 women whose ER+ breast cancer had been surgically treated. One group was randomized to five years of tamoxifen therapy, and the other randomized to tamoxifen for two years followed by three years of anastrozole, an aromatase inhibitor ... "Among the patients randomized to tamoxifen, poor metabolizers had a 3.8-fold increase in risk of developing breast... (EurekAlert!)

    Tau protein expression predicts breast cancer survival -- though not as expected  Dec 14, 2008
    "On the other hand," he continued, "patients with high levels of Tau-and we knew these patients were not particularly sensitive to chemotherapy-actually did very well. They had a significantly better survival in this large randomized study.". Pusztai noted that survival is determined by baseline prognosis, endocrine sensitivity and sensitivity to chemotherapy-and that Tao is a marker of receptivity for two of these important variables. (EurekAlert!)

    New data from largest-ever clinical trials in CLL show Rituxan (Rituximab) enables leukemia patients to live longer without their disease progressing  Dec 12, 2008
    These data, which come from the largest randomized clinical trials ever reported in CLL, suggest that Rituxan (MabThera) used in combination with chemotherapy has the potential to become the new standard of care for CLL patients. " CLL is the most common type of leukemia in adults, accounting for approximately 25-30% of all forms of leukemia. Incidence of CLL in Western countries is around 3 per 100,000, and is twice as common in men compared to women. It mainly affects the elderly with 95% of... (Canada Newswire)

    Brand-name Drugs Do Not Appear Superior To Generic Drugs For Treating Cardiovascular Diseases  Dec 12, 2008
    The researchers identified 47 articles for detailed analysis, covering nine different subclasses of cardiovascular drugs, of which 38 (81 percent) were randomized controlled trials (RCTs). Clinical equivalence was noted in 7 of 7 RCTs (100 percent) of beta-blockers, 10 of 11 RCTs (91 percent) of diuretics, 5 of 7 RCTs (71 percent) of calcium-channel blockers, 3 of 3 RCTs (100 percent) of antiplatelet agents, 2 of 2 RCTs (100 percent) of statins, 1 of 1 RCT (100 percent) of angiotensin-converting... (Science Daily)

    Egypt: Violence, Crime And the Hip-Hop Identity - Sudanese Youth in Cairo [analysis]  Dec 12, 2008
    In many ways, the Outlaws and Lost Boys have recreated the civil conflict in Sudan, positioning themselves as soldiers fighting for a cause rather than armed youth engaging in randomized violence. This is exhibited through: (1) accused affiliations pitting the two groups against each other because of support from the Sudan Peoples Liberation Army/Government of South Sudan (SPLA/GoSS) and the Khartoum government; (2) the strategic, mission-like character of a majority of the attacks; and (3) the... (allAfrica.com)

    WHO calls for major clinical trial for vitamin D  Dec 12, 2008
    "The only way to further address the cause-effect issue is to organize new randomized trials" looking at vitamin D and mortality from common conditions, including cancer, it said. Pending these trials, which could take years, the agency said it is premature for people to start popping vitamin D pills, a position that puts it at odds with advice from the Canadian Cancer Society, which last year became the first major public health advocacy group in the world to recommend population-wide use of... (Globe and Mail)

    BiPar Sciences Presents Interim Phase 2 Results for PARP Inhibitor BSI-201 At San Antonio Breast Cancer Symposium  Dec 12, 2008
    The poster titled ``Triple Negative Metastatic Breast Cancer: A Phase 2, Multi-Center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin (G/C) With or Without BSI-201, a PARP Inhibitor'' was presented during the SABCS's second poster session on Friday, December 12, 2008 ... The trial participants were randomized into two different trial arms; one group who received chemotherapy (G/C) alone and one group who had BSI-201 added to their G/C regimen. (Primezone Releases)

    Meta-analyses of global trials finds in favor of aromatase inhibitors  Dec 12, 2008
    AIOG is a subset of the Early Breast Cancer Trials Collaborative Group (EBCTCG), a global organization of researchers that studies all randomized evidence of therapies used to treat breast cancer to find insights not apparent from examining individual trials a technique known as a meta-analysis ... Cohort 1 consists of clinical trials in which patients were randomized to treatment with either tamoxifen or aromatase inhibitors for five years ... Cohort 2 included studies in which breast cancer... (EurekAlert!)

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