Minimally Invasive Surgery Shown Safe And Effective Treatment For Rectal Cancer Nov 12, 2009
That fact plus its relatively small sample size, lack of randomization, and relatively short follow-up period all point to the need for large, randomized studies before its findings can be considered definitive. Dr. Milsom reports that his surgical team is now participating in two such studies, one in collaboration with the American College of Surgeons Oncology Group (ACSOG) and the other headed up by Dr. Lee and involving several other U.S. medical centers. (Science Daily)
High-definition Colonoscopy Detects More Polyps, Researchers Say Nov 1, 2009
"So there was a natural randomization of patients to either standard or high-definition endoscopes, and physicians were not able to cherry-pick their patients," Dr. Wallace says. "No doctors used high definition more than any other and, in this way, you can eliminate most of the variables that can bias results of a clinical trial.". (Science Daily)
Antibiotic Prophylaxis and Recurrent Urinary Tract Infection in Children Oct 29, 2009
Results From December 1998 to March 2007, a total of 576 children (of 780 planned) underwent randomization. The median age at entry was 14 months; 64% of the patients were girls, 42% had known vesicoureteral reflux (at least grade III in 53% of these patients), and 71% were enrolled after the first diagnosis of urinary tract infection. (New England Journal of Medicine)
Diamyd Medical AB (publ.): Fourth Quarter Report, Stockholm, October 23, 2009 Oct 23, 2009
Diamyd contracted Apoteket AB in 2004 for handling of blinding, randomization and labeling of the study drug for a clinical study with 160 LADA patients. As the study was unblinded and reported during summer 2007, the data was found to be inconclusive. (Primezone Releases)
Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients Oct 22, 2009
The primary outcome measure was death within 90 days after randomization ... At 90 days after randomization, 322 deaths had occurred in the higher-intensity group and 332 deaths in the lower-intensity group, for a mortality of 44. (New England Journal of Medicine)
Cancer drug is no different in effectiveness as gold standard treatment for macular degeneration Oct 10, 2009
Patients were enrolled by a 2:1 randomization to either the bevacizumab (2) or ranibizumab (1) arm of the study ... "Our study aimed to offer early, six-month results of a randomized, double-masked, single center clinical trial comparing the off-label use of bevacizumab with the current gold standard ranibizumab. With a total of 20 subjects and a 2:1 randomization, early results of this trial suggest that at 6 months, visual outcomes of bevacizumab appear to be no different from ranibizumab,"... (EurekAlert!)
PR Firm May Have Forged Political Polls Sep 26, 2009
Silver applied a statistical technique widely considered to have indicated fraud in the recent Iranian elections, taking advantage of the fact "that human beings are really bad at randomization." Real randomization should occur in the final digits of polling numbers; that is, there should be roughly as many results ending in "2" (such as 42 percent of respondants favoring John McCain in a presidential poll) as results ending in "3," for instance. But Silver found that the Strategic Vision LLC... (Slate)
One-year results from Horizons-AMI trial reported at TCT 2009 Sep 22, 2009
According to the lead researcher, Guido Parodi, MD, PhD, FESC, Associate Chief Invasive Cardiology, Careggi Hospital, University of Florence (Florence, Italy), "It was completely contrary to our expectations. In particular, we found that in those patients at the highest risk for dying at one year, randomization to bivalirudin instead of heparin plus a GPIIb/IIIa antagonist appeared to provide the greatest mortality benefit.". In this substudy of the HORIZONS-AMI trial, bivalirudin monotherapy... (EurekAlert!)
Arena Pharmaceuticals Reports Positive, Highly Significant BLOSSOM Trial Results for Weight Management; NDA Submission on Track for December Sep 18, 2009
As in BLOOM, significant weight loss compared to placebo was shown at the first trial visit, two weeks following randomization. The efficacy for the BLOOM and BLOSSOM trials after one year of treatment are summarized in the table below. (PR Newswire)
SHBG and Risk of Type 2 Diabetes in Women and Men Sep 17, 2009
Plasma levels of sex hormone binding globulin were measured; two polymorphisms of the gene encoding sex hormone binding globulin, SHBG, that were robustly associated with the protein levels were genotyped and applied in mendelian randomization analyses ... In mendelian randomization analyses, the predicted odds ratio of type 2 diabetes per standard-deviation increase in the plasma level of sex hormone binding globulin was 0. (New England Journal of Medicine)
Duration of Androgen Suppression in Prostate Cancer Sep 17, 2009
To the Editor: In the trial conducted by Bolla et al. (June 11 issue),1 more than 70% of the patients had clinical T3 disease, and the median level of prostate-specific antigen (PSA) in patients who underwent randomization was 18. 8 ng per milliliter, with a range of up to 159. (New England Journal of Medicine)
Immediate Intervention For Patients With Acute Coronary Syndromes Not Always More Beneficial Sep 15, 2009
"Time from randomization to sheath insertion [beginning of the catheterization procedure] was 70 minutes with immediate intervention vs. 21 hours with delayed intervention," the authors report. "Troponin I release, as reflected by peak value collected during hospitalization, did not differ between the two strategies in the immediate and delayed intervention groups. The probability of MI as measured by the curves of troponin peak values was similar with either strategy." The authors also found... (Science Daily)
Fluvastatin in Patients Undergoing Vascular Surgery Sep 3, 2009
Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. (New England Journal of Medicine)
Video: Phase III Head to Head Trial Showed Ticagrelor Reduced Cardiovascular Death and Heart Attacks Over Clopidogrel in Acute Coronary Syndromes Patients Aug 30, 2009
The other two subgroups (patients not taking a statin medication on the day of randomization and those at sites in North America) showed no treatment advantage for ticagrelor. Of the 33 safety subgroups analyzed, 32 were consistent with the analysis of safety in the overall population; showing no statistically significant difference between ticagrelor and clopidogrel. (PR Newswire)
Takeda Initiates Cardiovascular Outcomes Trial for Alogliptin, An Investigational Treatment for Type 2 Diabetes Aug 28, 2009
Title: A Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment with Alogliptin in Addition to Standard of Care in Subjects with Type 2 Diabetes and Acute Coronary Syndrome Study Start: September 2009 Study Completion: December 2014 No. of Patients: Approximately 5,400 Primary Outcome: Time from randomization to the occurrence of the Primary Major Adverse Cardiac Events defined as a composite of cardiovascular death, nonfatal... (PR Newswire)
Results In 'The New England Journal Of Medicine' Confirm Novartis Drug Femara(R) Is Superior To Tamoxifen After Breast Cancer Surgery Aug 20, 2009
The primary endpoint of the study was disease-free survival, defined as the time from randomization to the first of any of the following events: recurrence at local, regional, or distant sites; a new invasive cancer in the contralateral breast; any second, non-breast cancer; or death without a previous cancer event. Other endpoints included time to breast cancer recurrence, time to distant breast cancer recurrence and overall survival. (PR Newswire)
UT Southwestern physicians bust myths about insulin Aug 11, 2009
" More than 20 million Americans have type 2 diabetes. Obesity, age and lack of exercise all increase the risk for the disease, which is characterized by a progressive loss of insulin-producing beta cells. Diabetes is the single greatest independent risk factor for heart disease, as well as a contributor to a number of other medical problems, including blindness and kidney disease. The standard initial treatment for type 2 diabetes is a single drug, often metformin, followed by the addition of... (EurekAlert!)
Men with Angina Do Worse Than Women Aug 8, 2009
"Treatment was decided upon not by randomization but just by defining the condition," Fonarow said. "You need a randomized clinical trial to get definitive results.". (MEDLINEplus)
Friendship Influences Eating Behavior, Particularly When Friends Are Overweight Aug 6, 2009
After randomization, there were 33 friend pairs and 39 "unfamiliar" pairs. Before taking part in the study experiment, participants listed what they had eaten in the past 24 hours to make sure they hadn't eaten anything during the previous two hours, and rated their hunger level. (Science Daily)
Apixaban or Enoxaparin for Thromboprophylaxis after Knee Replacement Aug 6, 2009
Results A total of 3195 patients underwent randomization, with 1599 assigned to the apixaban group and 1596 to the enoxaparin group; 908 subjects were not eligible for the efficacy analysis. The overall rate of primary events was much lower than anticipated. (New England Journal of Medicine)
School-based Program Helps Prevent Dating Violence Among Teens, Especially Boys Aug 5, 2009
"This study contributes to what we know about the prevention of adolescent dating violence in two important ways. First, randomization of adolescents to an intervention condition provides support for the position that school-based interventions can have causal effects on adolescents' romantic relationships, although this may be true only for boys," they continue. "Second, this study provides proof of principle that effective classroom-based interventions targeting relationship violence can be... (Science Daily)
Lung volume reduction surgery shown to prolong and improve life for some emphysema patients Jul 24, 2009
"NETT was landmark study: randomization was necessary at that point as we did not know the true benefits of the surgery," said Dr. Benzo. "We now know the individuals that benefit from it. Randomization would be unethical now in the group of individuals that we now know get benefit. This study shed light on the palliative (overall well-being) benefits of the surgery, which many patients consider as important as the survival benefit. (EurekAlert!)
Easy strength training exercise may help treat tennis elbow, study shows Jul 11, 2009
In fact, given the consistently poor outcomes for patients in the standard treatment group, it was deemed appropriate to terminate the randomization with 21 of the intended 30 patients having already completed the study. "Compared to other treatments for tennis elbow such as cortisone injections or topical nitric oxide which require direct medical supervision and often side effects, this treatment is not only cost effective but dosage is not limited by the patient having to come to a clinic,"... (EurekAlert!)
Social Security numbers too easy Jul 7, 2009
The solution, the researchers say, is randomization. But even that would be a short-term approach. (Pittsburgh Post-Gazette, PA)
Study suggests C-reactive protein doesn't cause heart disease Jul 1, 2009
To look at the issue, Paul Elliott of Imperial College London, used a technique called Mendelian randomization, which is based on the arbitrary assignment of genes from parent to child a bit like assigning someone either a placebo or a real drug ... "A null Mendelian randomization may not mean very much," Dr. Paul M. Ridker, the director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital, in Boston, Massachusetts said. (CNN -- Health)
Routine Early Angioplasty after Fibrinolysis for Acute Myocardial Infarction Jun 25, 2009
5 hours after randomization and in 98 ... 8 hours after randomization. (New England Journal of Medicine)
Treatment for Type 2 Diabetes and Coronary Artery Disease Jun 16, 2009
Randomization was stratified according to the choice of percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) as the more appropriate intervention. Results At 5 years, rates of survival did not differ significantly between the revascularization group (88. (New England Journal of Medicine)
Keryx Biopharmaceuticals Reports Positive Data from a Randomized, Multi-Center, Placebo-Controlled, Phase 2 Combination Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer Jun 1, 2009
1)} *Survival calculated from date of randomization until date of death from any cause, whether or not additional therapies were received after removal from treatment. As of May 2009, median overall survival in the perifosine + capecitabine patient group is ongoing with 10 of the 20 patients in this arm still alive. (PR Newswire)
Early Glycoprotein IIb/IIIa Inhibition in Acute Coronary Syndromes May 21, 2009
Key safety end points were bleeding and the need for transfusion within the first 120 hours after randomization. Results The primary end point occurred in 9. (New England Journal of Medicine)
Early versus Delayed Invasive Intervention in Acute Coronary Syndromes May 21, 2009
24 hours after randomization) or delayed intervention (coronary angiography. 36 hours after randomization). (New England Journal of Medicine)
Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS) May 20, 2009
Enrollment of both trials was completed in less than 13 months following randomization of the first patient into the program in late April 2006. Ninety-seven percent (97%) of all patients in the two CAPACITY studies who were living and had not received a lung transplant, completed their Week 72 study visit. (PR Newswire)
Immunotherapy effective against neuroblastoma in children May 15, 2009
The trial patient randomization was halted early because of the benefit seen, and all patients enrolled in the trial will receive immunotherapy plus standard treatment. Yu noted that the two-year mark is especially important because past trials have shown that those neuroblastoma patients who live without disease for two years after a stem cell transplant will most likely be cured. (EurekAlert!)
What Is The Best Strategy For Overcoming Constant Worries? Apr 10, 2009
In a randomized controlled study, 73 outpatients meeting DSM-IV criteria for GAD as primary diagnosis were allocated to either WE or AR or a waiting list control group; in a 2nd randomization procedure the waiting list subjects were reallocated to WE or AR.. The treatment was manualized (15 sessions with WE or AR), included 6-month and 1-year follow-ups, as well as last observation carried forward and completer analyses, and was controlled for allegiance effects. (Science Daily)
Intensive vs. Conventional Glucose Control in Critically Ill Patients Mar 26, 2009
We defined the primary end point as death from any cause within 90 days after randomization. Results Of the 6104 patients who underwent randomization, 3054 were assigned to undergo intensive control and 3050 to undergo conventional control; data with regard to the primary outcome at day 90 were available for 3010 and 3012 patients, respectively. (New England Journal of Medicine)
Savient Provides Update on Pegloticase BLA Feb 13, 2009
It is important to note that in the Phase 3 trials, there was a 2:2:1 randomization used, meaning that 4 times as many patients were on drug than placebo. However, in the Open Label Extension study virtually all patients were on drug with only 2 going on observation. (PR Newswire)
Aspirin reduces colon polyps recurring Feb 12, 2009
Among 2,698 participants who underwent colonoscopic follow-up after randomization, 37% of the participants assigned to placebo developed adenomas compared with 33% of those assigned to aspirin. Moreover, 12% of the participants assigned to placebo developed advanced adenomas compared with 9% of the participants assigned to aspirin. (Times of India)
Study adds to evidence of vaccine safety Feb 8, 2009
Randomization sets the new study apart. The random assignment of children rules out the chance that factors other than thimerosal, such as education or poverty, caused the results. (Chippewa Falls Chippewa Herald, WI)
