New Study Findings Confirm CLEXANE(R)/LOVENOX(R) Long-Term Clinical Benefit in Patients Suffering From Acute Coronary Syndrome Sep 3, 2007
ExTRACT TIMI 25 was a major randomized clinical trial that supported the worldwide submission and subsequent approval by the FDA and some European countries of the new Lovenox(R) indication for the treatment of patients with acute ST-segment elevation myocardial infarction (STEMI). STEEPLE (SafeTy and Efficacy of Enoxaparin in Percutaneous Coronary Intervention Patients) trial one year follow up shows that the composite of all cause death at 1 year and major bleeding was 3. (PR Newswire)
Hypnosis - Effective Pain Reliever for Breast Cancer Surgery Sep 1, 2007
" In a randomized clinical trial, 200 women scheduled for a breast biopsy or lumpectomy [removal of tumor without mastectomy] underwent a 15-minute hypnosis session before they went into the operating room. Others just had a consultation with a psychologist. While hypnosis has been studied before, this was the first time it was part of breast cancer treatment. Helen Dorman describes the pain of her surgery: "You sort of feel like you've been rolled over by a Mack [a brand of large truck] truck... (Voice of America)
Hypnosis Reduces Pain And Costs In Breast Cancer Surgery Aug 31, 2007
Article: Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, et al. A Randomized Clinical Trial of a Brief Hypnosis Intervention to Control Side Effects in Breast Surgery Patients. J Natl Cancer Inst 2007; 99:1304-1312. (Science Daily)
Hypnosis eases breast cancer surgery pain: study Aug 29, 2007
"This is a randomized clinical trial of 200 patients that really showed beneficial effects for patients," said Guy Montgomery of Mount Sinai School of Medicine in New York. "It really works well.". (Scientific American)
Migraine trial under way Aug 29, 2007
San Diego-based CryoCor said it has enrolled more than 170 patients in a randomized clinical trial of its ablation system for treating atrial fibrillation. Santarus signs a deal. (San Diego Union-Tribune -- Business)
FDA Gives Medtronic Cervical Disk Green Light Aug 28, 2007
The Prestige Cervical Disc underwent a prospective, multi-center, randomized clinical trial to assess its safety and effectiveness based on comparisons between data collected from patients with single-level symptomatic cervical DDD at one level between C3-C7. The investigational group of 276 patients received the Prestige Cervical Disc device while the 265 patients in the control group received an anterior plated surgical fusion utilizing bone graft and plate stabilization. (dBTechno)
It smells fishy - and that's good Aug 20, 2007
The reliability of many of these studies is limited by small sample sizes, animal-only subjects or the observational (rather than randomized clinical trial) design of the research. Within these limitations, some results are encouraging. (San Francisco Chronicle)
Sirr: Women's Health in Venezuela Aug 16, 2007
Condom use promotes regression of cervical intraepithelial neoplasia and clearance of human papillomavirus: a randomized clinical trial. Hogewoning CJ; Bleeker MC; van den Brule AJ; Voorhorst FJ; Snijders PJ; Berkhof J; Westenend PJ; Meijer CJ Int J Cancer. (Zmag.org)
DNA Vaccine Against Multiple Sclerosis Appears Safe, Potentially Beneficial Aug 15, 2007
Based on these results, a phase 2b trial--a randomized clinical trial in approximately 290 patients--of BHT-3009 is already under way. "If successful in MS, antigen-specific DNA vaccines can be developed for prevention or treatment of related diseases, such as type 1 diabetes mellitus, systemic lupus erythematosus, rheumatoid arthritis and myasthenia gravis," the authors conclude. (Science Daily)
DNA vaccine could help MS sufferers: study Aug 14, 2007
But based on the findings, a randomized clinical trial involving administering BHT-3009 to approximately 290 patients is underway with hopes that successful treatment of MS sufferers could pave the way for the development of similar vaccines to prevent or treat related diseases such as Type 1 diabetes, lupus and rheumatoid arthritis, researchers concluded. "Eventually, and this is a goal for farther down the road, we believe that the targets of these diseases may not be identical across... (CTV.ca)
New Study Questions Avandia's Heart Risk Aug 9, 2007
That means their data fall short of the gold standard -- a randomized clinical trial -- so they "will neither solve the overriding problems of drug safety nor ultimately help a chronically underfunded federal agency," he said. More information. (Health-Finder)
Inhaled nitric oxide safe for tiny preemie lungs, UCSF study finds Aug 7, 2007
The controlled, randomized clinical trial of nitric oxide was headed by Roberta Ballard, MD, UCSF professor emeritus of neonatology who coordinated the trial while serving as chief of the division of neonatology at Childrens Hospital of Philadelphia. The trial included 582 very premature infants who were enrolled between 2000 and 2005 in the study at 7 to 21 days old at 21 hospitals around the country. (EurekAlert!)
Africa: Daily HIV/Aids Report Jul 26, 2007
He added, "This is the first randomized clinical trial that shows that infants treated before three months of age will do better than infants who have their treatment delayed.". Anthony Fauci, director of NIAID, said, "The results of this trial could have significant public health implications worldwide because these findings will cause experts to consider changes in standards of care in many parts of the world" (Reuters, 7/24). (AllAfrica.com)
Treating HIV-infected Infants Early Helps Them Live Longer Jul 26, 2007
This trial, called the "Children with HIV Early Antiretroviral Therapy" (CHER) study, is a phase III, randomized clinical trial led by Avy Violari, M.D., FCPaed (SA), of the University of the Witwatersrand in Johannesburg, South Africa, and Mark Cotton, MBChB, MMed, of the University of Stellenbosch in Cape Town, South Africa ... "Children with HIV infection frequently show rapid disease progression within the first year of life due to their developing immune systems and susceptibility to other... (Science Daily)
Eating Fish Urged to Counter Binge-Drinking Effects on Fatty Acids Jul 26, 2007
Note that the findings came from a retrospective review of data, not a randomized clinical trial. As alcohol consumption increased in men, dietary intake of total saturated fatty acids, total monounsaturated fatty acids (MUFA), and total polyunsaturated acids (PUFA) decreased significantly (P=0. (MedPage Today)
Early treatment sees more HIV babies survive Jul 24, 2007
"This is the first randomized clinical trial that shows that infants treated before 3 months of age will do better than infants who have their treatment delayed," Zerhouni said in a statement. The study of 337 babies aged 6 to 12 weeks was initially aimed at examining whether early antiretroviral drug therapy over a limited period would delay HIV progression. (Scientific American)
Study confirms that NSAIDs treatment can reduce colorectal cancer risk Jul 24, 2007
It would be ideal to conduct a randomized clinical trial in which half the patients receive NSAIDs at doses higher than those used in prior trials and half receive placebos and follow both groups for many years for evidence of cancer. But such trials are expensive, time consuming, and could present real health risks to participants. (EurekAlert!)
Study: Zocor May Prevent Alzheimer's, Parkinson's Jul 20, 2007
This was a broad observational study rather than a gold-standard randomized clinical trial, in which all the variables are carefully controlled. "At least one, sometimes two, randomized clinical trials would be required before the FDA would approve marketing the drug for Alzheimer's or dementia," says Dr. Samuel Gandy, chair of the Alzheimer's Association's medical and scientific advisory council. (MSNBC -- Health)
Exceeding '5 A Day' Guide For Veggie, Fruit Intake Doesn't Reduce Chance Of Breast Cancer Recurrence, Study Finds Jul 19, 2007
The study is the largest-ever randomized clinical trial to assess the connection between diet and breast cancer recurrence. Stanford was one of seven sites for the trial. (Science Daily)
Selenium Supplements May Increase The Risk Of Type 2 Diabetes Jul 16, 2007
Results of a randomized clinical trial using 200 micrograms of selenium alone showed that 55 percent more cases of type 2 diabetes developed among participants randomized to receive selenium than in those who received a placebo pill. Results will appear in print in the August 2007 issue of Annals of Internal Medicine and were posted online on July 10. (Science Daily)
Tomatoes show little effect in reducing cancer risk Jul 12, 2007
Others point out that this was a review of previous studies, not a large, randomized clinical trial, which could have yielded stronger results. "It reaffirms what we keep learning over and over again," said Dr. David Katz, director of the Prevention Research Center at Yale University School of Medicine. (abc13.com)
Glaxo's Avandia stirs debate at diabetes meeting Jun 26, 2007
One audience member called the publication of the study irresponsible, in light of an ongoing randomized clinical trial looking at heart effects of the drug. That elicited applause from the audience; but Nissen's response that he had an ethical obligation to publish his findings also drew applause. (Scientific American)
New Study Shows A1c Reduced Safely By Patients With Type 2 Diabetes Using Self-Adjusted Dosing Starting With Once-Daily Insulin Treatment Levemir(R) Jun 25, 2007
"The study is a testament to the safety of Levemir(R), as patients were able to adjust their basal insulin dose on their own and achieve the same level of glycemic control as when guided by their doctor, while reducing the risk of hypoglycemia," said Luigi Meneghini, MD, MBA, Associate Professor of Clinical Medicine and the Director of the Eleanor and Joseph Kosow Diabetes Treatment Center at the Diabetes Research Institute, Miami, FL. "Since having type 2 diabetes requires a great deal of... (PR Newswire)
University of Zurich announces worldwide clinical trial of Cardiac Resynchronization Therapy Jun 23, 2007
The worldwide study, called "Echocardiography guided Cardiac Resynchronization Therapy (EchoCRT)", is the first prospective randomized clinical trial to evaluate the impact of cardiac resynchronization therapy in patients with advanced heart failure (NYHA Class III) and a narrow QRS complex who show mechanical dyssynchrony as assessed by echocardiography. "It is established that CRT provides clinical benefit for heart failure patients with wide QRS," said Johannes Holzmeister, MD, University of... (EurekAlert!)
One-step Breast Cancer Treatment Combines Radiation, Surgery Jun 21, 2007
McCready and Fyles will join a randomized clinical trial to further study the results of using this procedure. The study participants from PMH will generally be older patients with small, early-stage tumours (less than 2 cm). (Science Daily)
Estrogen Therapy and Coronary-Artery Calcification Jun 21, 2007
We examined the relationship between estrogen therapy and coronary-artery calcium in the context of a randomized clinical trial. Methods In our ancillary substudy of the Women's Health Initiative trial of conjugated equine estrogens (0. (New England Journal of Medicine)
Folic Acid Does Not Prevent Colorectal Tumours New Study Suggests Jun 6, 2007
"Folic Acid for the Prevention of Colorectal Adenomas: A Randomized Clinical Trial." Bernard F. Cole; John A. Baron; Robert S. Sandler; Robert W. Haile; Dennis J. Ahnen; Robert S. Bresalier; Gail McKeown-Eyssen; Robert W. Summers; Richard I. Rothstein; Carol A. Burke; Dale C. Snover; Timothy R. Church; John I. Allen; Douglas J. Robertson; Gerald J. Beck; John H. Bond; Tim Byers; Jack S. Mandel; Leila A. Mott; Loretta H. Pearson; Elizabeth L. Barry; Judy R. Rees; Norman Marcon; Fred Saibil; Per... (Medical News Today)
Dasatinib shows high early response rate as first treatment for chronic myelogenous leukemia Jun 3, 2007
The comparison to historical data provides insight into dasatinib's effect, but a randomized clinical trial comparing medications directly would present a more detailed picture. Imatinib, known commercially as Gleevec and produced by Novartis Pharmaceuticals, was the first drug to target the fusion protein BCR-ABL that causes the disease. (EurekAlert!)
Doctors Conclude Temsirolimus Is Effective New Treatment For Advanced Renal Cell Carcinoma Jun 1, 2007
The results of a phase III, randomized clinical study involving patients with advanced renal cell carcinoma and poor prognostic features show temsirolimus improved overall survival when compared to the current treatment for this stage of disease. The study, led by Gary R. Hudes, M.D., director of the Genitourinary Malignancies Program at Fox Chase Cancer Center, is published in the May 31 issue of the New England Journal of Medicine. (Science Daily)
Dietary vitamin B6. B12 and folate, may decrease pancreatic cancer risk among lean people Jun 1, 2007
The researchers say their study cannot definitively say that one carbon nutrients either pose a benefit or a hazard to most people, but they note that it is the best analysis that can be performed outside of a randomized clinical trial. . (EurekAlert!)
FDA approves new kidney cancer drug May 31, 2007
"It would be reasonable to hypothesize that temsirolimus could provide greater benefit to patients with less extensive metastatic disease. Only a randomized clinical trial will give us that definitive knowledge," Hudes said. More information. (Atlanta Journal-Constitution)
Effect of Burch Colposuspension versus Fascial Sling to Reduce Urinary Stress Incontinence May 22, 2007
Background Many surgical procedures are available for women with urinary stress incontinence, yet few randomized clinical trials have been conducted to provide a basis for treatment recommendations. Methods We performed a multicenter, randomized clinical trial comparing two procedures the pubovaginal sling, using autologous rectus fascia, and the Burch colposuspension among women with stress incontinence. (New England Journal of Medicine)
Reducing Cardiovascular Disease Risk Factors When Discontinuing Hormone Replacement Therapy May 17, 2007
Participants were part of the five-year Women On the Move through Activity and Nutrition (WOMAN) study, a randomized clinical trial of CVD prevention. The focus of this investigation was 240 women who were taking HRT at baseline; 134 of these women were randomized to the lifestyle intervention and the remaining 106 were randomized to the health education group. (Science Daily)
Coenzyme Q10 Does Not Improve Parkinson's Disease Symptoms May 16, 2007
Alexander Storch, M.D., of the Technical University of Dresden, Germany, and colleagues conducted a randomized clinical trial of a 300-milligram dose of CoQ10 in 131 patients with Parkinson's disease who did not have changes in motor functions and were on stable treatment for their condition. Those assigned to the treatment group took 100 milligrams of CoQ10 three times daily for three months, followed by a two-month "washout" period. (Science Daily)
Infants with bronchiolitis may benefit more from albuterol May 16, 2007
In a paper to be presented at the 2007 Society for Academic Emergency Medicine (SAEM) Annual Meeting, a double-blind randomized clinical trial involving over 700 infants over a three year period showed a clear advantage for albuterol in successful discharges from the Emergency Department. Although many smaller studies have shown either no difference or an advantage to epinephrine, this surprising result of a small but real advantage in using albuterol may force physicians to reassess their... (EurekAlert!)
Data Show Low Incidence of Breakthrough Bleeding With ORTHO TRI-CYCLEN(R) LO In a Broad Range of Women May 9, 2007
The findings are based on a retrospective analysis of data from a randomized clinical trial evaluating the safety and efficacy of ORTHO TRI- CYCLEN LO compared to Loestrin(R) Fe 1/20 (norethindrone acetate/20 mcg ethinyl estradiol) tablets. The study evaluated the incidence of breakthrough bleeding and spotting in 1,506 women using ORTHO TRI-CYCLEN LO versus 1,057 women using norethindrone acetate/20 mcg ethinyl estradiol tablets for up to 13 continuous menstrual cycles. (PR Newswire)
Aspirin: A wonder drug for women? May 2, 2007
Experts agree that the Nurses Health Study has considerable statistical power because of its size and the 24 years of follow-up, but they also note its limitations as an observational study, which isn't as reliable as a randomized clinical trial. John Baron, an epidemiologist at Dartmouth Medical School who comments on Chan's study in the same issue of the Archives of Internal Medicine, says the response to the findings should be cautious. (Orlando Sentinel)
Novel transfusion strategy for pediatric patients in intensive care Apr 20, 2007
Montreal, April 19th, 2007 -- In its April 19th, 2007 edition, the New England Journal of Medicine published an article about the findings of a multi-center randomized clinical trial that compared transfusion strategies for patients in pediatric intensive care units. The study, led by Dr. Jacques Lacroix, a full professor in the Department of Pediatrics at the Universit de Montral and a pediatric intensivist as well as researcher at the CHU Sainte-Justine, a university hospital center, was... (EurekAlert!)
Survival Data Available From ERBITUX(R) Study in First-Line Treatment of Advanced Head and Neck Cancer Apr 4, 2007
"We are excited by the results of this study, as it is the first large, randomized clinical trial to examine the impact of ERBITUX treatment in combination with platinum-based chemotherapy on overall survival in metastatic head and neck cancer," said Eric Rowinsky, M.D., Chief Medical Officer and Senior Vice President of ImClone Systems. "ERBITUX has already demonstrated improved survival when combined with radiation in locoregionally advanced head and neck cancer." "When ERBITUX was approved... (PR Newswire)
Dark chocolates perk up blood vessel function: Study Mar 27, 2007
"In this group of healthy adults with BMI between 25 and 35 kg/m2, dark chocolate ingestion over a short period of time was shown to significantly improve endothelial function, leading our team to believe that greater benefit may be seen through a long-term, randomized clinical trial," co-investigator, Dr. Valentine Yanchou Njike of Yale Prevention Research Center said. However, cautioning against chocolate overdoing, researchers called for larger studies to generate confirmed results. (The Money Times)
Studies explore lifestyle choices and heart risks Mar 25, 2007
"In this sample of healthy adults with BMI between 25 and 35 kg/m2, dark chocolate ingestion over a short period of time was shown to significantly improve endothelial function, leading our team to believe that greater benefit may be seen through a long-term, randomized clinical trial," said Valentine Yanchou Njike, M.D., of Yale Prevention Research Center, and co-investigator on this study. "While the findings from this study do not suggest that people should start eating more chocolate as part... (EurekAlert!)
Degrees in homeopathy slated as unscientific Mar 22, 2007
For advocates of evidence-based medicine, the double-blind randomized clinical trial (in which neither the doctor nor the patient knows who is getting active treatment and who is getting a placebo) is the best form of evidence available to practitioners ... "I definitely think homeopathy can, and should, be evaluated within the context of double-blind, placebo-controlled, randomized clinical trials," says Ellen Hughes, who teaches complementary therapies to medical students at the University of... (Nature News Service)
Obesity May Up Prostate Cancer Deaths Mar 17, 2007
"Although one would need a randomized clinical trial to definitively determine whether weight loss could be an effective complementary treatment for obese men diagnosed with prostate cancer, these results offer yet another good reason for men to achieve and maintain a healthy weight," Kristal says. By Miranda Hitti Reviewed by Louise Chang 2005-2006 WebMD, Inc. All rights reserved. (CBS News)
Tykerb (lapatinib) - new anti-cancer treatment approved Mar 15, 2007
The approval of Tykerb was based on a randomized clinical trial in about 400 women with advanced or metastatic breast cancer that was also HER2 positive. In the trial, half the patients received Tykerb with capecitabine and half received capecitabine alone. (News-Medical.net)
Viagra Drug May Help Improve Exercise Capacity In Pulmonary Fibrosis Patients Mar 14, 2007
"The next step is to confirm this finding in a large, randomized clinical trial." The study was funded by the National Institutes of Health. Other authors include: Dr. Harold R. Collard, department of medicine, San Francisco General Hospital, University of California, San Francisco; Kevin J. Anstrom, Ph. (Science Daily)
Taking AIM at post-stroke depression Feb 17, 2007
INDIANAPOLIS Activating patients and developing a monitoring and evaluation system was highly effective in ending or reducing post-stroke depression in patients enrolled in the largest randomized clinical trial to date for this prevalent and disabling consequence of stroke. Researchers from the Richard L. Roudebush Veterans Administration Medical Center, the Regenstrief Institute and the Indiana University School of Medicine report in the March issue of the journal Stroke, that AIM, a new... (EurekAlert!)
More doubt cast on value of drug-coated stents Feb 13, 2007
A company executive singled out the Swedish study as "far from definitive" because it was an uncontrolled registry of patients rather than a randomized clinical trial. Both Boston Scientific and Johnson & Johnson, the other major stent maker, are sponsoring further trials to assess the safety and effectiveness of stents in more complex cases. (Boston Globe)
Celexa Effective Against Depression with Heart Patients Jan 24, 2007
Point out that a large randomized clinical trial is still necessary to determine whether treatment of depression in these patients has beneficial effects on the occurrence of cardiovascular events ... "For that a large, randomized clinical trial is urgently needed.". (MedPage Today)
Prostate Cancer Trial Halted Due to 3 Cases of Leukemia Jan 21, 2007
"Of importance, this possible increase in risk would not have been identified so early without a randomized clinical trial that allowed comparison between a group receiving standard treatment and a group receiving a novel therapy approach," Glode added. One expert thinks the decision to end the trial was correct. (Forbes)
New international study to test exercise in heart failure patients Jan 20, 2007
The new trial, called Heart Failure and A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) "is the largest randomized clinical trial of exercise training ever performed," Kitzman said. "The trial represents a critical step in establishing exercise as a therapy for patients with left ventricular dysfunction" (reduced heart contractions). (EurekAlert!)
Combined Heart and Stroke Prevention Surgery Ups Death Risk Jan 16, 2007
"Given this significant increase in postoperative stroke and death, a randomized clinical trial of the combined surgery is needed to determine the benefit, if any, compared to performing the operations in separate hospitalizations.". RELATED LINKS. (Scientific American)
Low-dose Aspirin Offers Lower Chance Of Asthma Jan 16, 2007
(July 8, 2005) -- The Women's Health Study (WHS) -- the largest randomized clinical trial to investigate the impact of aspirin and vitamin E on the primary prevention of cardiovascular and cancer risk -- has helped. . (Science Daily)