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    News and Articles on Randomization

    Archives: Randomization

    Decontamination of the Digestive Tract and Oropharynx in ICU Patients  Jan 1, 2009
    Methods We evaluated the effectiveness of SDD and SOD in a crossover study using cluster randomization in 13 intensive care units (ICUs), all in the Netherlands. Patients with an expected duration of intubation of more than 48 hours or an expected ICU stay of more than 72 hours were eligible. (New England Journal of Medicine)

    Video: Gleevec Receives US Approval as First Treatment To Reduce Risk of Cancer Returning in Patients with Gastrointestinal Stromal Tumors  Dec 20, 2008
    The efficacy endpoint of the study was recurrence-free survival (RFS), defined as the time from the date of randomization to the date of recurrence or death from any cause. Participants were randomized to receive either Gleevec 400 mg/day or a matching placebo for one year(4). (PR Newswire)

    Alfuzosin in Chronic Prostatitis–Chronic Pelvic Pain Syndrome  Dec 18, 2008
    Results A total of 272 eligible participants underwent randomization, and in both study groups, 49. 3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin, 0. (New England Journal of Medicine)

    Meta-analyses of global trials finds in favor of aromatase inhibitors  Dec 12, 2008
    In cohort 2, six years after the randomization, there was a 3. 5 percent reduced risk of breast cancer recurrence in women who switched to aromatase inhibitors, compared to women who continued using tamoxifen. (EurekAlert!)

    GSK Reports PROMACTA(R) (eltrombopag) Significantly Increased Platelet Counts and Reduced Bleeding in Long-Term Study of Patients With Chronic ITP  Dec 7, 2008
    The study enrolled 197 patients (PROMACTA: n=135; placebo: n=62) and, of these, approximately 50 percent had platelet counts less than or equal to 15,000/microliters; about 50 percent were receiving simultaneous ITP therapies at randomization; around 35 percent were splenectomized, and more than 50 percent had received at least three prior ITP medications. Patients began once daily treatment with PROMACTA at 50 mg (or matching placebo) with doses individualized based upon each patient's platelet... (PR Newswire)

    Prolonged Therapy of Advanced Chronic Hepatitis C with Low-Dose Peginterferon  Dec 4, 2008
    5 years after randomization. The primary end point was progression of liver disease, as indicated by death, hepatocellular carcinoma, hepatic decompensation, or, for those with bridging fibrosis at baseline, an increase in the Ishak fibrosis score of 2 or more points. (New England Journal of Medicine)

    No protective effect on cancer from long-term vitamin E or vitamin C supplementation  Nov 17, 2008
    Analyses indicate that randomization to vitamin E did not have a significant effect on prostate cancer. This lack of effect for vitamin E also extended to total cancer. (EurekAlert!)

    Long-term study evaluates boosted PREZISTA* vs. lopinavir/ritonavir as part of HIV combination therapy in treatment-naive adults  Nov 12, 2008
    Patient randomization was stratified based on viral load and CD4+ cell count. (2) The main objective of the study was to demonstrate non-inferiority of once-daily PREZISTA/r versus lopinavir/r in proportion of patients achieving virologic response, defined as confirmed HIV-1 RNA (below 50 copies/mL. Non-inferiority of PREZISTA/r vs. lopinavir/r was defined as a maximum allowable difference of 12 per cent for virologic response, with a one-sided significance level of alpha equals to 0. (Canada Newswire)

    Testosterone for Low Libido in Postmenopausal Women Not Taking Estrogen  Nov 6, 2008
    Breast cancer was diagnosed in four women who received testosterone (as compared with none who received placebo); one of the four received the diagnosis in the first 4 months of the study period, and one, in retrospect, had symptoms before undergoing randomization. Conclusions In postmenopausal women not receiving estrogen therapy, treatment with a patch delivering 300 g of testosterone per day resulted in a modest but meaningful improvement in sexual function. (New England Journal of Medicine)

    Improved Rodent Trials Can Speed Cancer Drug Development, Expert Suggests  Oct 31, 2008
    The key steps include the identification and use of an appropriate animal model and study endpoints, correct statistical evaluation of the data, proper randomization, and inclusion of a sufficient number of animals for statistically meaningful data. Hollingshead also argues for the inclusion of enough methodological detail in the published article to allow readers to fully interpret and understand the implications of those data. (Science Daily)

    UNC Lineberger launches 44-county study of breast cancer in black women  Oct 31, 2008
    For the study results to be unbiased, women must be selected through a scientific randomization process, and an equal number of black women and white women will be recruited over a four-year period. No treatment of any kind will be given as part of the study. (EurekAlert!)

    Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults  Oct 27, 2008
    Patient randomization was stratified based on viral load and CD4+ cell count. The main objective of the study was to demonstrate non-inferiority of PREZISTA/r versus lopinavir/r in proportion of patients achieving virologic response, defined as confirmed HIV RNA or = 2 percent) reported of at least moderate to severe intensity (> or = Grade 2) were diarrhea (6 percent), headache (5 percent), abdominal pain (4 percent), nausea (3 percent), vomiting (2 percent), and rash (2 percent). (PR Newswire)

    Long-Term Follow-up after Control of Blood Pressure in Diabetes  Oct 10, 2008
    Seven prespecified aggregate clinical end points were examined on an intention-to-treat basis, according to the previous randomization categories. Results Differences in blood pressure between the two groups during the trial disappeared within 2 years after termination of the trial. (New England Journal of Medicine)

    10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes  Oct 10, 2008
    We examined seven prespecified aggregate clinical outcomes from the UKPDS on an intention-to-treat basis, according to previous randomization categories. Results Between-group differences in glycated hemoglobin levels were lost after the first year. (New England Journal of Medicine)

    Telmisartan to Prevent Recurrent Stroke and Cardiovascular Events  Sep 18, 2008
    Results The median interval from stroke to randomization was 15 days. During a mean follow-up of 2. (New England Journal of Medicine)

    Phase Forward acquires Clarix  Sep 8, 2008
    Clarix s fully Web-integrated interactive response technology is used for subject randomization, predictive medication inventory management and operational management and reporting in clinical trials. Phase Forward CEO Bob Weiler noted that Clarix s technology will improve customer satisfaction and enable his company to offer a broader array of clinical trial solutions. (Boston Business Journal, MA)

    Magnesium Sulfate for the Prevention of Cerebral Palsy  Aug 28, 2008
    Results A total of 2241 women underwent randomization. The baseline characteristics were similar in the two groups. (New England Journal of Medicine)

    Tadalafil shows promise for relief of lower urinary tract symptoms associated with BPH  Aug 19, 2008
    All participants then received placebo for 4 weeks prior to randomization. The 1056 subjects were then divided randomly into 5 groups that received a placebo, or doses of 2. (EurekAlert!)

    Bivalirudin vs. Unfractionated Heparin during PCI  Aug 14, 2008
    The primary end point was the composite of death, myocardial infarction, urgent target-vessel revascularization due to myocardial ischemia within 30 days after randomization, or major bleeding during the index hospitalization (with a net clinical benefit defined as a reduction in the incidence of the end point). The secondary end point was the composite of death, myocardial infarction, or urgent target-vessel revascularization. (New England Journal of Medicine)

    Levels Of C-reactive Protein In The Blood Do Not Cause Diabetes  Aug 13, 2008
    Brunner and colleagues use a technique called Mendelian randomization to control for the effect of other variables (such as obesity, blood pressure, and socio-economic position) which might play a role in the development of diabetes ... Brunner et al. Inflammation, Insulin Resistance, and Diabetes Mendelian Randomization Using CRP Haplotypes Points Upstream. (Science Daily)

    For strokes, closest hospital might not be best  Aug 12, 2008
    To answer the question with some certainty, the trial uses randomization admitting patients to the trial with similar conditions and randomly assigning some to the drug treatment, the others to the catheter. So less than 15 minutes later, a computer in another state decides Booker's fate. (USA Today)

    BELLUS Health moves forward on nutraceutical and pharmaceutical fronts - Reports Results for First Half of 2008  Aug 5, 2008
    A Phase II clinical trial in diabetic patients was launched in Canada and patient randomization commenced during the current quarter. The study is a 26-week, double-blind, placebo-controlled, randomized study. (Canada Newswire)

    Firewall vendors scramble to fix DNS problem  Aug 5, 2008
    Some firewall software undoes a source port randomization feature that was introduced in the DNS patches ... Firewalls that do IP (Internet Protocol) address translation -- converting the IP addresses used by computers on their internal networks to different IP addresses that are used by the other computers on the Internet -- can sometimes undo the source port randomization, security experts say. (InfoWorld)

    Apple DNS Security Patch Flawed, Leaves Users At Risk  Aug 2, 2008
    Apple's update was supposed to introduce randomization to help block poisoning attacks, a threat exposed by the DNS flaw. But even after installing the patch, Storms said his system still was not randomizing the source port. (CRN)

    Bowel prep oral sodium phosphate equal to fasting before capsule endoscopy for obscure GI bleeding  Jun 18, 2008
    After swallowing the capsule, the patients were not to drink for two hours and not eat for four hours regardless of randomization ... Sixteen experienced investigators in eight centers, blinded to the randomization, independently evaluated the CE images. (EurekAlert!)

    New Treatment Patch For Traveler's Diarrhea  Jun 13, 2008
    New Treatment Patch For Traveler's Diarrhea. The Lancet reportspromising results for patches that vaccinate travelers againstdiarrhea. (Medical News Today)

    Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function  Jun 2, 2008
    1 percent of the patients (9/126) in the CellCept-based regimen in combination with CNI. Mean time from transplant to randomization in both groups was 117 days. Baseline characteristics and measured GFR values were similar in the treatment groups and 98 patients in the CellCept-based regimen in combination with SRL were receiving tacrolimus. (PR Newswire)

    Video: Major Independent Trial Demonstrates Significant Anticancer Benefit of Zometa(R) in Women With Early-Stage Breast Cancer  Jun 1, 2008
    (Disease-free survival was defined as the length of time after randomization during which patients had no local recurrence, contralateral breast cancer, distant metastasis, secondary carcinoma, and/or death from any cause. Recurrence-free survival was defined as the length of time after randomization during which patients had no local recurrence, contralateral breast cancer, distant metastasis, and/or secondary carcinoma. (PR Newswire)

    Sahajanand Medical Technologies PAINT Trial Results Support Safety and Efficacy of the Infinnium and Supralimus Stents  May 21, 2008
    Primary investigator, Dr Pedro Lemos of the Heart Institute (InCor) University of Sao Paulo Medical School, Brazil, commented that, "The design of PAINT (2:2:1 randomization of 280 patient with coronary de novo lesions) allowed to verify, in a single trial, the safety and efficacy of the two novel drug-eluting stent formulations." He added that "Another important point is that most previous comparative trials between Sirolimus taxel used stents with two different platforms and polymers." "In the... (PR Newswire)

    Concomitant treatment with nebulized formoterol fumarate & tio-significant improvements -- COPD  May 21, 2008
    Following randomization, subjects entered a six-week treatment period to evaluate the safety and efficacy of formoterol fumarate inhalation solution (FFIS; Perforomist, 20 g/2mL) while maintaining once-daily treatment with TIO. The primary efficacy endpoint was standardized area under the curve for FEV1 over three hours (FEV1 AUC0-3) at the last visit (week 6). The standardized absolute AUC0-3 for FEV1 following the first dose of study medication at Day 1 was statistically significantly... (EurekAlert!)

    AEterna Zentaris: Article on Phase 2 Trial with Cetrorelix in BPH to be Published in European Urology Journal  May 13, 2008
    Main and secondary endpoints included I-PSS, PFR and mean uroflow, residual urinary volume, prostate volume, plasma testosterone, quality of life, and sexual function which were evaluated over a total of 20 weeks after randomization. Results In all cetrorelix groups, a rapid improvement in mean I-PSS was obtained, with a peak effect of -5. (Canada Newswire)

    Study reveals inaccuracies in studies of cancer treatment  Apr 21, 2008
    Clinical trials are considered the gold standard for demonstrating the effectiveness of new treatments for cancer, but observational studies, which do not involve randomization but where available data are nonetheless analyzed to make treatment comparisons, have also been used to provide information on how well patients respond to particular drugs. Many investigators perform these types of studies by analyzing data from the Surveillance, Epidemiology and End Results (SEER) Tumor Registry, a... (EurekAlert!)

    Weekly Paclitaxel and Breast Cancer  Apr 17, 2008
    After randomization, all patients first received 4 cycles of intravenous doxorubicin and cyclophosphamide at 3-week intervals and were then assigned to intravenous paclitaxel or docetaxel given at 3-week intervals for 4 cycles or at 1-week intervals for 12 cycles. The primary end point was disease-free survival. (New England Journal of Medicine)

    AEterna Zentaris Completes Patient Recruitment for First Phase 3 Efficacy Trial with Cetrorelix in Benign Prostatic Hyperplasia  Apr 15, 2008
    About the Phase 3 Program with Cetrorelix in BPH The first multi-center efficacy study commenced first patient randomization in April 2007 and completion of patient recruitment was announced today. It is currently being conducted primarily in the United States and Canada, with additional sites in Europe and involves approximately 600 patients under the supervision of lead investigator, Herbert Lepor, MD, Professor at NY University School of Medicine, New York. (Canada Newswire)

    Telmisartan, Ramipril, or Both in High-Risk Vascular Disease  Apr 10, 2008
    Methods After a 3-week, single-blind run-in period, patients underwent double-blind randomization, with 8576 assigned to receive 10 mg of ramipril per day, 8542 assigned to receive 80 mg of telmisartan per day, and 8502 assigned to receive both drugs (combination therapy). The primary composite outcome was death from cardiovascular causes, myocardial infarction, stroke, or hospitalization for heart failure. (New England Journal of Medicine)

    Mixed Results For Weight Loss Drug, Rimonabant, On Slowing Progression Of Coronary Disease  Apr 6, 2008
    The patients returned for scheduled clinic visits at 3, 6, 12, and 18 months following randomization. The main outcome the researchers were observing was a change in the percent atheroma volume (PAV) and the secondary outcome was a change in normalized total atheroma volume (TAV). (Science Daily)

    Drug-Eluting Stents Outperform Bare Stents in Heart Attack  Mar 31, 2008
    The new study, which involved 16 medical centers, enrolled 745 patients who were set to undergo PCI for STEMI. Patients were randomly assigned to an infusion of abciximab or high-dose tirofiban (25 microgram/kg) and, in a second round of randomization, to treatment with either uncoated or sirolimus-eluting stents. To judge the effectiveness of tirofiban and abciximab, researchers examined electrocardiograms -- 722 of which were interpretable -- to determine the proportion of patients with at... (PR Newswire)

    Group-Randomized Cancer Trials Often Statistically Flawed  Mar 29, 2008
    " The findings came from a review of 75 group-randomized clinical trials, which the authors defined as comparative studies involving random assignment of identifiable groups to protocol-specified conditions. Individuals within the randomized groups are observed to assess the effects of an intervention. "The group-randomized trial is the gold standard in public health and medicine when randomization of individuals is not possible," the authors noted. "Group randomization will be required whenever... (MedPage Today)

    Perioperative Eloxatin(R)-Based Regimen Significantly Reduced the Risk of Relapse Versus Surgery Alone in Eligible Colorectal Cancer Patients with Initially Resectable Liver Metastases  Mar 21, 2008
    PFS is the time from randomization until disease progression/recurrence or death. The EORTC 40983 Intergroup study is also referred to as the EPOC (Eloxatin(R) for Peri-Operative Use) trial. (PR Newswire)

    Alcohol Intake Increases Risk Of Hypertension, High Blood Pressure In Certain Populations  Mar 6, 2008
    Journal reference: Chen L, Davey Smith G, Harbord R, Lewis SJ (2008) Alcohol and blood pressure: A systematic review implementing a mendelian randomization approach. PLoS Med 5(3): e52. (Science Daily)

    Regular Drinking Raises Blood Pressure, Meta-Analysis Affirms  Mar 5, 2008
    " In the three studies that reported hypertension outcomes for a total of 4,219 participants, men who drank more were at higher risk. Men with the *1*1 genotype had 2.42-fold higher risk than those with the *2*2 genotype (95% CI 1.66 to 3.55, P=0.0000048). Men with the *1*2 genotype had 1.72-fold higher risk than those with the *2*2 genotype (95% CI 1.17 to 2.52, P=0.006). The same effect was seen in the five studies that reported blood pressure outcomes for a total of 7,658 participants. Mean... (MedPage Today)

    Surgery for Spinal Stenosis Provides Better Outcome  Feb 23, 2008
    The study consisted of a randomized group of patients given surgery or nonsurgical care and an observational cohort of patients who declined randomization. However, there were incidents of frequent crossovers in both directions in the randomized and observational groups and was therefore not definitive, the researchers said. (MedHeadlines)

    Penwest Announces Results of Phase IIa Clinical Study of Nalbuphine ER  Feb 4, 2008
    The study group included a 2-to-1 randomization of patients on drug versus placebo. Nalbuphine ER, designed to be taken as a twice-daily tablet, is formulated using Penwest's TIMERx(r) drug delivery technology. (Primezone Releases)

    Ustekinumab Phase 3 data show long-term improvement of chronic plaque psoriasis  Feb 3, 2008
    After the randomization at week 40, 46 percent and 49 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, respectively, experienced at least one AE, compared with 56 and 48 percent of patients switched to placebo. Serious AEs were observed in 0 and 1 percent of patients continuing treatment with 45 mg and 90 mg ustekinumab, compared with 0 and 2 percent of patients switched to placebo. (EurekAlert!)

    Gene Variations Associated With Effectiveness Of Blood Pressure Medications  Jan 25, 2008
    "We also observed a pharmacogenetic association of NPPA T2238 on change in systolic and diastolic blood pressure 6 months after treatment randomization in a similar direction: generally, minor C allele carriers had greater reductions in blood pressure when randomized to chlorthalidone vs. either lisinopril or doxazosin relative to those with the common TT genotype," the authors write. "This study demonstrates the importance (and sometimes paradoxical findings) of pharmacogenetic research; for... (Science Daily)

    Combination Therapy Improves Survival For Certain Prostate Cancer Patients  Jan 24, 2008
    D., of Brigham and Women's Hospital and Dana Farber Cancer Institute, Boston, and colleagues performed an analysis of overall survival of 206 men with localized but unfavorable--risk prostate cancer in subgroups defined by their level of comorbidity at the time of their randomization to AST and RT vs. RT alone. During a median follow-up of 7. (Science Daily)

    Etanercept for Psoriasis  Jan 17, 2008
    At week 36, 138 patients underwent a second randomization to placebo or etanercept to investigate the effects of withdrawal and retreatment ... During the withdrawal period from week 36 to week 48, response was lost by 29 of 69 patients (42%) assigned to placebo at the second randomization. (New England Journal of Medicine)

    Similar Outcomes For Patients With ACS Treated With Different Anticoagulant Regimens  Jan 3, 2008
    In the Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) trial, randomization of moderate-risk and high-risk patients with ACS undergoing early invasive management to monotherapy with the direct thrombin (blood-clotting enzyme) inhibitor bivalirudin compared with a heparin-based regimen plus glycoprotein (GP) IIb/IIIa inhibitors resulted in noninferior 30-day rates of adverse ischemic events with reduced rates of major bleeding. The long-term effect of bivalirudin... (Science Daily)

    Physician-scientist urges improved drug regulation to ensure heart ...  Jan 1, 2008
    Analysis plans should be designed to incorporate all data collected during development, including results of so-called observational studies (which do not employ randomization to eliminate study bias, and which do not employ "control" groups for comparison) in order to increase statistical power to find problems if they exist. Currently, this kind of analysis plan is not usually employed. (Hindu)

    Key hole surgery no better than conservative management  Dec 14, 2007
    The primary outcome was the Kujala score on patellofemoral pain and function at 9 months following randomization. Secondary outcomes were visual analog scales (VASs) to assess activity-related symptoms. (BioMed Central)

    Complete response with oblimersen combination improves survival of CLL patients  Dec 10, 2007
    Patients were followed for at least three years after randomization or until death or withdrawal from the study. Of the 20 oblimersen-treated patients with a complete response at the end of the first year, 12 survived at least four years. (EurekAlert!)

    More on Cetuximab in Head and Neck Cancer  Nov 22, 2007
    The authors used the Kaplan Meier method to estimate locoregional control, defining its duration as the "time from randomization until the first documented progression or recurrence of locoregional disease or until death from any cause." This. . (New England Journal of Medicine)

    Cetuximab for the Treatment of Colorectal Cancer  Nov 15, 2007
    Methods From December 2003 to August 2005, 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine, irinotecan, and oxaliplatin or had contraindications to treatment with these drugs underwent randomization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care (287 patients) or best supportive care... (New England Journal of Medicine)

    FDA Accepts Chelsea Therapeutics' Investigational New Drug Application for Droxidopa  Nov 12, 2007
    Both pivotal efficacy trials will utilize an enrichment design where all potential participants are initially screened to demonstrate both a blood pressure and symptomatic improvement with Droxidopa prior to randomization to either placebo or active treatment. The primary endpoint for each trial will be a statistically significant improvement in symptomatic benefit between active and placebo, as defined by Item 1 (assessment of dizziness or light-headedness) of the Orthostatic Hypotension... (Primezone Releases)

    Prevention of Preterm Delivery  Nov 8, 2007
    The elevated infant mortality in the studies cited is probably related to randomization bias, in our view. 2,3 More recent randomized trials4,5 show similar tocolytic efficacy, fewer maternal side effects, and no excess infant deaths with atosiban, as compared with other tocolytic. (New England Journal of Medicine)

    Prophylactic Cranial Irradiation in Small-Cell Lung Cancer  Nov 8, 2007
    Brain imaging was not part of standard staging before randomization unless symptoms suggestive of metastasis were present. Published data suggest that up to 15% of patients have asymptomatic brain metastases, and the prognosis for these patients is similar to that for patients with symptomatic metastases. (New England Journal of Medicine)

    Changing the way doctors treat high blood pressure  Nov 6, 2007
    To examine this question, we conducted a cluster randomization trial. Family practices were randomly assigned to implement a simplified step-care algorithm (STITCH-care) or Guidelines-based care for the management of hypertension. (EurekAlert!)

    Comparison of glucosamine sulfate and a polyherbal supplement for the relief of osteoarthritis of the knee: a randomized controlled trial [ISRCTN25438351]  Nov 1, 2007
    Subject randomization was effective: age, gender and disease status distribution was similar in both groups. The response rates (20% reduction in WOMAC pain) were substantial for both glucosamine (89%) and reparagen (94%) and supported by investigator and subject assessments. (BioMed Central)

    Year End Report for Diamyd Medical AB, Fiscal Year 2006/2007  Oct 26, 2007
    In June 2007, a Phase II study in LADA patients was invalidated as non- GCP (Good Clinical Practice) conformances were found at the pharmacy responsible for labeling and randomization of study drug. Net sales were SEK 531,000 (US$ 77,518) compared to SEK 4,323,000 (US$ 631,094) for the prior year. (BusinessWire)

    TPF Therapy in Unresectable Head and Neck Cancer  Oct 25, 2007
    Results A total of 358 patients underwent randomization, with 177 assigned to the TPF group and 181 to the PF group. At a median follow-up of 32. (New England Journal of Medicine)

    Corticosteroids Judged Superior for Bell's Palsy  Oct 18, 2007
    "The high rate of acceptance of randomization and the low dropout rate during the study suggest that our results can probably be applied to other settings with similar populations," they wrote. "It is possible that genetic polymorphisms that are prevalent in some populations or environmental factors such as diet could alter the response.". (MedPage Today)

    Early Treatment with Prednisolone or Acyclovir in Bell’s Palsy  Oct 18, 2007
    Results Final outcomes were assessed for 496 of 551 patients who underwent randomization. At 3 months, the proportions of patients who had recovered facial function were 83. (New England Journal of Medicine)

    Statins reduce loss of function, keeping old lungs young - even in smokers  Oct 13, 2007
    But because of overlap between groups and the lack of randomization and controls in this study, the researchers point out that further data is needed before any definitive conclusions are drawn. Their findings do, however, support the hypothesis that statins reduce the annual loss of lung function that occurs with age. (EurekAlert!)

    Depression Management by Phone Called Win-Win  Sep 26, 2007
    Employees identified as having significant depression but not bipolar disorder, substance disorder, history of recent mental health treatment, or suicidality were eligible for randomization. The patients were assigned to receive a telephone-based outreach and care-management program in which the workers were encouraged by a care manager -- a licensed master's degree-level clinical employed by the managed care company -- to enter outpatient therapy, consisting of psychotherapy and/or... (MedPage Today)

    Fewer Heart Attacks Reported with Cypher (Sirolimus-Eluting) Stent  Sep 17, 2007
    This network meta-analysis design "integrated evidence from direct and indirect comparisons while fully preserving randomization," they wrote. Among the findings. (MedPage Today)

    Saline or Albumin in Traumatic Brain Injury  Aug 30, 2007
    13 on the Glasgow Coma Scale [GCS]), we recorded baseline characteristics from case-report forms, clinical records, and CT scans and determined vital status and functional neurologic outcomes 24 months after randomization. Results We followed 460 patients, of whom 231 (50. (New England Journal of Medicine)

    Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients  Aug 18, 2007
    There were 19 patients enrolled in the study with 18 patients receiving treatment with NEUVENGE. Patients underwent three infusions of NEUVENGE at Weeks 0, 2, and 4 following randomization. Patients who achieved a partial response, or had stable disease lasting through Week 52, were eligible for re-treatment, a booster, using the same protocol and dose as the initial treatment. (PR Newswire)

    Prophylactic Cranial Irradiation in Extensive Small-Cell Lung Cancer  Aug 16, 2007
    7 months after randomization. The 1-year survival rate was 27. (New England Journal of Medicine)

    For Screening for Atrial Fibrillation, the Pulse Is the Thing  Aug 4, 2007
    The cluster randomized trial, conducted at 50 primary care centers in England, included 14,802 patients, 65 or older, with further randomization to the two intervention practices. Screening took place over 12 months from October 2001 to February 2003. (MedPage Today)

    Selenium Supplements Linked To Type 2 Diabetes  Jul 10, 2007
    " They said this is an important result for public health because selenium supplements in 30 to 200 microgram doses are used by people throughout the US and the western world. However the authors said that despite these findings, there is evidence that selenium supplementation may help to prevent cancer. Larger randomized clinical trials are currently looking into this further. The study also had limitations the researchers conceded. First, the main trial was not designed to look at diabetes but... (Medical News Today)

    Estrogen Therapy and Coronary-Artery Calcification  Jun 21, 2007
    625 mg per day) as compared with placebo in women who had undergone hysterectomy, we performed computed tomography of the heart in 1064 women aged 50 to 59 years at randomization ... 7 years after randomization) ... Coronary-artery calcium (or Agatston) scores were measured at a central reading center without knowledge of randomization status. (New England Journal of Medicine)

    Evidence Lacking To Guide Treatment For Sudden Hearing Loss  Jun 20, 2007
    "The method of randomization was described in two studies. Validity scores ranged from two to eight (of nine). Positive results were reported favoring systemic steroids, intratympanic [inside the inner ear] steroids, batroxobin, magnesium, vitamin E and hyperbaric oxygen, although there were serious limitations in each study with a positive finding.". This includes the article cited as the landmark study for the use of steroids, which was not described as a randomized trial and therefore may... (Science Daily)

    Drug Company Funding Of Drug Trials Greatly Influences Outcome  Jun 6, 2007
    But this analysis adjusted for "confounders" -- study aspects that can influence the results, such as study design, including randomization, blinding, sample size, even choice of comparison drug in the study. Inclusion of the confounders still pointed to industry sponsorship as the most influential factor related to positive results and conclusions. (Science Daily)

    Health Canada's approval of an expanded indication for PLAVIX(R) (clopidogrel bisulfate) now offers protection from all types of heart attacks  Jun 5, 2007
    Results of the COMMIT/CCS-2 trial demonstrated that in the 28 days following randomization, clopidogrel, taken with aspirin and standard therapy, reduced the relative risk of death in STEMI patients by seven per cent (event rate: 7. 5% vs. 8. (Canada Newswire)

    Poniard Pharmaceuticals Announces Results of Picoplatin Phase 2 Trial That Confirm and Extend Survival Benefit in Small Cell Lung Cancer  Jun 4, 2007
    The trial has a 2:1 randomization comparing the efficacy and safety of intravenous picoplatin plus best supportive care to best supportive care alone. The Company expects to enroll approximately 400 patients in the trial, which is being conducted at clinical sites in Europe and India. (PR Newswire)

    Back Surgery Can Quickly Relieve Pain  May 31, 2007
    "Fifty percent of patients [in the early surgery group] were recovered in 4 weeks after randomization, whereas prolonged conservative care would need 12 weeks before 50 percent were recovered.". "I would recommend to wait a little longer and delay the decision to perform surgery until three to six months after the start of leg pain. If, however, sciatica pain does not allow you to work or care for yourself or your family, early surgery remains a very good option and is safe," said Peul. (Forbes)

    Surgery versus Prolonged Conservative Treatment for Sciatica  May 31, 2007
    The primary outcomes were the score on the Roland Disability Questionnaire, the score on the visual-analogue scale for leg pain, and the patient's report of perceived recovery during the first year after randomization. Repeated-measures analysis according to the intention-to-treat principle was used to estimate the outcome curves for both groups. (New England Journal of Medicine)

    Novel Treatments May Help Alleviate Constipation, Irritable Bowel Syndrome In Women  May 24, 2007
    Endpoints were pain intensity, pain frequency and other symptoms, such as nausea, headache and appetite, which were recorded at baseline, one, two, and three months after randomization and six and 12 months after therapy. Researchers defined "cure" as those who experienced greater than 80 percent improvement in pain. (Science Daily)

    Aspirin Aids in Colorectal Cancer Prevention  May 12, 2007
    Patients were randomized to 300 mg or 1,200 mg aspirin a day or a placebo for one to seven years depending on the date of randomization ... The greatest benefit was seen after five or more years of aspirin use 10 to 14 years after randomization (HR 0. (MedPage Today)

    Low-Salt Diet Shakes Off Heart Disease  Apr 21, 2007
    A 25% reduction in risk of cardiovascular disease among sodium reduction groups versus controls after adjustment for clinic site, demographics, and randomization to weight- loss intervention (relative risk 0. 75, 95% confidence interval 0. (MedPage Today)

    Novel transfusion strategy for pediatric patients in intensive care  Apr 20, 2007
    There were 14 deaths in each group within 28 days after randomization. Furthermore, none of the other outcomes analyzed, including adverse events, revealed any significant differences. (EurekAlert!)

    Diagnosis of Ventilator-Associated Pneumonia  Apr 5, 2007
    8%) of the 365 patients in the bronchoalveolar-lavage group had received new antibiotics within 3 days before randomization, probably after the onset of the first symptoms related to ventilator-associated pneumonia. Since these patients were different from the rest of the patients,2,3 we wonder how decisions concerning. (New England Journal of Medicine)

    ACC: Atherosclerosis Impervious to HDL Infusions  Mar 27, 2007
    All patients had an acute coronary syndrome--unstable angina, or non-ST-segment or ST-segment elevation myocardial infarction-within two weeks prior to randomization. They also had at least one 20% or greater narrowing on coronary angiography at baseline though no greater than 50% stenosis in the left main coronary artery or liver disease. (MedPage Today)

    Tykerb (lapatinib) - new anti-cancer treatment approved  Mar 15, 2007
    The primary endpoint of time-to-progression (TTP) was defined as time from randomization to tumor progression or death related to breast cancer. After the results of a pre-specified interim analysis of 324 patients were made available, further enrollment was discontinued after enrolling 399 patients of a planned 528 patients. (News-Medical.net)

    Anemia drugs increase death risk  Mar 11, 2007
    The dose of pegylated epoetin beta was titrated to maintain the hemoglobin level between 11 and 13 g/dL. An interim analysis, after randomization of 153 patients, demonstrated a numerical imbalance in the number of deaths across the four arms of the study. FDA has not yet received the complete study results, and will review and analyze the data after they are submitted by Hoffmann-La Roche. (Food Consumer)

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