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randomization in Medical News

Men With Angina Do Worse Than Women

...at the medical practices rather than being a controlled trial in which participants are carefully matched, he said. "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." But the difference in outcome ...

Lung volume reduction surgery shown to prolong and improve life for some emphysema patients

...the quality of life benefit comes right away." "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 ben...

Quigley Corporation Announces Final Results of Quigley Pharma's Phase IIb Study

...es of 18 and 70 with a diagnosis of diabetic neuropathy were enrolled in the study. Duration of treatment : Treatment commenced at randomization (Visit 2) and continued for 12 weeks; study duration for each patient was approximately 22 weeks. Endpoints: Efficacy: The...

Easy Strength Training Exercise May Help Treat Tennis Elbow, Study Shows

...ed to strength. 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 inje...

Perceptive Informatics Enhances CNS and Oncology Medical Image Processing and Analysis Capabilities Through Alliance With Biospective

...logy that benefits from extensive medical and clinical expertise as well as a deep understanding of the regulatory environment. The portfolio includes randomization and Trial Supply Management (RTSM) technologies, Medical Imaging, Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC), and Electro...

Perceptive Informatics Launches the Next Level of Integration in its Industry-Leading eClinical Suite

...te. The solution allows users to perform real-time randomization and dispensation activities directly from within t...ality built into the DataLabs EDC and ClinPhone(R) randomization and Trial Supply Management (RTSM) technologies. ...the regulatory environment. The portfolio includes randomization and Trial Supply Management (RTSM) technologies, M...

BBK Worldwide Foresees Expanding Global Demand for Patient Recruitment Technology

... efficiencies for enrollment of patients; and 6) instantaneous reporting on randomization and retention metrics. "For the world of increasingly savvy Internet users ...urately monitor patient progress from initial inquiry to screening and from randomization through all visits to study completion," added Bachenheimer. "We've always ...

DATATRAK Announces New Products and Features at DIA San Diego

...management of users' training programs as well as the ability to deploy content in a SCORM compliant environment DATATRAK IRT - standalone randomization and inventory management The Learning Resource Center - an in depth resource and help center for our CRO, Sponsor and Tria...

Immunotherapy effective against neuroblastoma in children

... were living free of cancer compared to 46 percent in the standard treatment group. Overall survival improved significantly as well. 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 ...

BELLUS Health reports results for first quarter of fiscal 2009

...abolic syndrome. During the second quarter of 2008, a Phase II clinical trial in diabetic patients was initiated in Canada and patient recruitment and randomization commenced. The study is a randomized 26-week, double-blind, placebo-controlled study. Interim results are anticipated late in the second quarter or ea...
randomization in Medical Technology

XTL Biopharmaceuticals Announces Completion of Patient Randomization Into the Bicifadine Phase 2b Clinical Trial for the Treatment of Diabetic Neuropathic Pain

VALLEY COTTAGE, N.Y., June 30 /PRNewswire-FirstCall/ -- XTL Biopharmaceuticals Ltd. (Nasdaq: XTLB ; TASE: XTL) today announced that it has completed patient randomization into its Phase 2b study of Bicifadine -- a serotonin and norepinephrine reuptake inhibitor (SNRI) -- for the treatment of ...

Two Phase III clinical trials on corifollitropin alfa (Org 36286) reach randomization target

OSS, the Netherlands, June 27, 2007-Organon, the human healthcare business unit of Akzo Nobel, announced today that two out of three Phase III clinical trials with corifollitropin alfa (Org 36286), a new long-acting fertility hormone, have reached their randomization target. Corifollitropin al...

DOR BioPharma Receives EMEA Agreement on the Design of its Confirmatory Phase 3 Clinical Trial of orBec(R) in GI GVHD

...tient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04,...

Keryx Biopharmaceuticals Announces 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

...fosine 22 {95% CI (12.1, NR)} 26% Increase** Capecitabine + Placebo 16.3 {95% CI (5.3, 17.1)} * 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 200...

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

...ne 22 {95% CI (12.1, NR)} 26% Increase** Capecitabine + Placebo 16.3 {95% CI (5.3, 17.1)} *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, med...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

...h the placebo group across both studies and were considered exploratory. 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 ...

Ongoing Landmark ROADMAP Study Demonstrates Significant Improvement in Blood Pressure Control at One Year, According to Blinded Results

...ized into the following JNC 7 classifications: normal, pre-hypertension, Stage 1 and Stage 2 hypertension. Mean BP for the overall population at study randomization was 136.2/80.6 mm Hg. In the 4,013 patients who remained on double-blind treatment with either olmesartan medoxomil therapy or placebo after one year,...

ISTA Pharmaceuticals Highlights Bepreve(TM) Clinical Data at the Association for Research in Vision and Ophthalmology (ARVO) 2009 Annual Meeting

...e pediatric subjects in this age group (n = 45) were among 861 patients enrolled in this masked, randomized, placebo-controlled clinical trial, with a randomization of 2:1 (Bepreve 1.5%:placebo). The proportion of subjects in the Bepreve 1.5% treatment group with an adverse event (22.5%) was very similar to that ...

Corgenix AspirinWorks(R) Test Recognized in POLYCAP Study at ACC.09

...d that the single combination pill was about as effective as taking the five drugs individually and was well tolerated. Trial results also showed that randomization to aspirin therapy resulted in a reduction in 11dTxB2, validating the findings of the previous CHARISMA trial. "The use of the AspirinWorks Test...

MAP Pharmaceuticals Announces Phase 3 Study of Unit Dose Budesonide in Children With Asthma Did Not Meet Primary Endpoints

...differences were not statistically significant. We observed a higher than expected response in the placebo group, starting as early as one week after randomization and continuing throughout the 12 week treatment period," said Timothy S. Nelson, Chief Executive Officer of MAP Pharmaceuticals. "We and our partner,...
randomization in Biological News

Common treatment to delay labor decreases preterm infants' risk for cerebral palsy

... randomly assigned to receive either placebo or magnesium sulfate. They all had similar characteristics, including gestational age (24 to 31 weeks) at randomization and risk factors for preterm birth. Eighty-seven percent of the women had experienced preterm membrane rupture. Those in the treatment group were g...

Physician-scientist urges improved drug regulation to ensure heart safety of non-heart drugs

...ans 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 exis...

Antivirals effectively curb influenza virus

... for planning management of seasonal influenza but also would be invaluable in pandemic planning. Additionally, simple solutions such as standardized randomization and study criteria would greatly facilitate trial comparison in the future. Such further studies will help us ensure we are better prepared not only f...

Disease diagnosis, bioengineering covered at state nano summit

... is to be achieved, then much more will need to be done in the area of protein design. He will discuss current advances in the use of selection and randomization to intelligently evolve protein function, as well as the role of these advances in the application of nanotechnology. For instance, in Krause's labora...

Signaling protein builds bigger, better bones in mice

...be sampling proteins, and thus may be simply representing experimental “noise.?Such results may come about from such procedural problems as incomplete randomization of samples, Baggerly says. The study raises a question that is broader than the effectiveness of the experimental ovarian cancer test, the research...

Cracking the olfactory code in bees

...be sampling proteins, and thus may be simply representing experimental “noise.?Such results may come about from such procedural problems as incomplete randomization of samples, Baggerly says. The study raises a question that is broader than the effectiveness of the experimental ovarian cancer test, the research...

New species from old data

...be sampling proteins, and thus may be simply representing experimental “noise.?Such results may come about from such procedural problems as incomplete randomization of samples, Baggerly says. The study raises a question that is broader than the effectiveness of the experimental ovarian cancer test, the research...

Another Look Finds Promising Proteomics Test is Not Biologically Plausible

...be sampling proteins, and thus may be simply representing experimental “noise.?Such results may come about from such procedural problems as incomplete randomization of samples, Baggerly says. The study raises a question that is broader than the effectiveness of the experimental ovarian cancer test, the research...
randomization in Biological Technology

Alba Therapeutics Announces the Enrollment and Randomization of the First Patient in the Phase IIb Clinical Trial for Larazotide Acetate (AT-1001) for the Treatment of Active Celiac Disease

BALTIMORE, May 16 /PRNewswire/ -- Alba Therapeutics Corporation announced today that it has enrolled and randomized its first patient in a twelve-week Phase IIb trial with oral larazotide acetate, an inhibitor of intestinal barrier dysfunction, for the treatment of patients with active celiac ...

DOR BioPharma Receives FDA Orphan Drug Designation for orBec(R) for the Treatment of Chronic Gastrointestinal GVHD

...tient (24%) deaths in the placebo group (p-value 0.0139). At one year post randomization in the Phase 3 trial, 18 patients (29%) in the orBec(R) group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, p=0.04). Based on data from the prior P...

Neurocrine Biosciences Reports Second Quarter 2009 Results

...d that elagolix has clinically meaningful efficacy coupled with a favorable safety profile. The Tulip Petal Study (0703) has completed subject randomization in Central Eastern Europe (n=174). This study is designed as a randomized, double-blind, placebo and active controlled trial with four treatment arms;...

Thoratec Announces Filing of PMA Seeking Destination Therapy Approval for HeartMate II(R)

...atec. In December 2008, Thoratec received approval from the FDA to end randomization in the trial, based on a pre-specified interim analysis of 67 percent of th...fety Monitoring Board concurred with Thoratec's recommendation to eliminate randomization for patients enrolled in the trial under FDA-approved CAPs. Patients i...

Sopherion Therapeutics Announces Completion of Enrollment in Phase III Study of Myocet in Metastatic Breast Cancer

...vious 12 months. Eligible patients were randomized to receive either Myocet, paclitaxel and trastuzumab, or paclitaxel and trastuzumab alone in a 1:1 randomization ratio. "Zoticon is delighted that Sopherion Therapeutics LLC has accomplished its recruitment objectives for the Phase III registration trial in...

InterMune Reports Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF

...h the placebo group across both studies and were considered exploratory. 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 ...

Perceptive Informatics Reaches Key Milestone Marking 10 Million IVRS Interactions In Support of Clinical Trials

... trial functions, including patient enrollment and randomization as well as study drug inventory management. P...add additional phone lines as needed. Perceptive's randomization and Trial Supply Management (RTSM) technologies, p... key features including a broad range of validated randomization methods, automated inventory control, dispensing a...

Pharmasset and Roche Obtain FDA Consent to Start a Phase 2b Study With R7128 in Treatment Naive HCV Patients

...n RVR will continue on the standard of care until week 48. According to the current study design, patients will be enrolled as two cohorts, with randomization of the second larger cohort being initiated based on 12 week safety data of the first cohort. During 2009, we expect to provide updates on the p...

Neurocrine Biosciences Reports Third Quarter 2008 Results

...d by the FDA. The first Phase II trial includes our selected commercial formulation tablet in two doses, (150 mg and 250 mg); this trial has completed randomization in 155 patients. The Company expects topline results from the first three months of treatment in the first quarter of 2009. The second trial is a four...

Human Genome Sciences Announces Second Quarter 2008 Financial Results and Key Developments

...ial in systemic lupus erythematosus; completion of randomization expected in August 2008 - ...in the study in August 2008. The Company completed randomization and initial dosing in BLISS-52 in April 2008. The ...a Trial Expected Third Quarter 2008; Completion of randomization in HGS-ETR1 NSCLC Trial Expected Shortly; HGS-ETR1...
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