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Intermediate in Medical Technology

Three Clinical Studies of bioTheranostics Molecular Breast Cancer Diagnostics Presented at San Antonio Breast Cancer Symposium

... Oncotype DX Recurrence Score (RS) of high, intermediate or low was previously reported. The study found ... survival. Patients with a high or intermediate HOXB13 expression did not experience a distant ... by providing a more informative picture of the intermediate risk group. We look forward to further expanding ...

/C O R R E C T I O N -- Agendia B.V./

... uncertain." In addition, the panel cautioned that so-called intermediate scores are not useful in clinical decision making. Currently, MammaPrint ... assay available that accurately yields a binary result, without an intermediate group, addressing the panel's recommendations. The FDA-cleared assay is ...

Agendia's Breast Cancer Recurrence Test MammaPrint Included in International St. Gallen Expert Consensus Recommendations

... uncertain." In addition, the panel cautioned that so-called intermediate scores are not useful in clinical decision making. Currently, MammaPrint ... assay available that accurately yields a binary result, without an intermediate group, addressing the panel's recommendations. The FDA-cleared assay is ...

Dacogen(R) (decitabine for injection) Data Presented on a Phase II Clinical Trial in Elderly Patients with Acute Myeloid Leukemia (AML)

... and 100,000/uL, respectively. The majority of patients in the trial had intermediate or poor risk cytogenetics (bone marrow tests to identify abnormal ... Of the 55 patients enrolled in the trial, most patients had intermediate (53 percent) or poor (42 percent) risk cytogenetics, which are associated ...

Callisto Pharmaceuticals Completes Enrollment of Phase II Trial of Atiprimod in Neuroendocrine Cancer

... enrollment of its Phase II clinical trial of Atiprimod to treat low to intermediate grade neuroendocrine carcinoma (advanced carcinoid cancer) was ... trial was to evaluate efficacy of Atiprimod in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable cancer ...

Isis Reports Strong Financial Results and Highlights for Second Quarter of 2009

... Our partnership strategy not only allows our drugs to move forward effectively toward the market but also provides us with significant short and intermediate term financial benefits that enable us to continue to advance the technology and fill the pipeline with more exciting new drugs," said B. Lynne ...

Prospective Clinical Advantages of Trabecular Metal(TM) Technology Highlighted in Comparative Study

... Trabecular Metal cups versus titanium cups with a similar geometry. This is the first study to quantify bone-remodeling around hip implants at an intermediate term (mean of 7.7 years) follow-up. Bone mineral density adjacent to acetabular implants was evaluated using quantitative computed tomography (QCT). ...

Genomic Health Study Shows Breast Cancers in Men Display Very Similar Gene Signatures to Those in Women

... The proportion of tumors with low risk of recurrence based on the Recurrence Score(R) was 53.6 percent in males versus 53.4 percent in females, intermediate risk of recurrence was 35.2 percent in males versus 36.3 percent in females, and high risk of recurrence was 11.2 percent in males versus 10.3 ...

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

... for the efficacy outcome measures of change in percent predicted FVC, PFS and DLco. On each of these outcome measures, the effect of 1197 mg was intermediate as compared to placebo and 2403 mg pirfenidone, indicative of a consistent dose-effect relationship. Similarly, a dose-response relationship was ...

Video: ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study

... were recently enrolled in the DEFINITIVE LE post-market study. DEFINITIVE LE is a prospective, multi-center, single-arm study to evaluate the intermediate and long-term effectiveness of stand-alone SilverHawk(R) Plaque Excision therapy for endovascular treatment of lower extremity peripheral arterial ...

SYNTAX Analysis Finds Treatment With TAXUS(R) Express2(TM) Stents More Cost Effective Than Bypass Surgery in Many Patients With Complex Coronary Artery Disease

... CABG patients, driven by the expected higher rate of revascularization in the PCI group. PCI and CABG patients whose scores fell into the lower or intermediate terciles of complexity had similar rates of MACCE at 12 months. The SYNTAX Score characterizes coronary anatomy based on lesion frequency, ...

Phase IV Multi-center Clinical Study of Kutai Concludes in Nanjing

... Kutai is a non-depolarizing skeletal muscle relaxant for intravenous administration. Compared to other neuromuscular blocking agents, it is intermediate in its onset and duration of action. More than 30 clinical experts from seven participating medical centers within China gathered in Nanjing ...

Freezing Prostate Cancer Does a Man's Body Good

... invasive treatments can cause side effects such as bladder control problems and erectile dysfunction (impotence). Men are classified as being at low, intermediate or high risk. The criteria used to categorize the risk include the results of the prostate-specific antigen (PSA) blood test (which looks for a ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... Interim data from an ongoing Phase 2 multicenter, randomized, double-blind, placebo-controlled study evaluating Nplate in patients with low or intermediate risk MDS receiving azacytidine were also presented (n=40). The interim analysis showed that Nplate reduced the incidence of clinically significant, ...

MGuard(TM) Coronary Stent System Approved in Israel

... up to six months. The study's primary endpoints are complete resolution of ST-segment elevation and restoration of flow through the occluded artery. intermediate results will be presented this week at the ICI '08 Meeting in Tel-Aviv. iMOS (international MGuard Observational study) will be launched soon. The ...

SYNTAX Data Show Comparable Safety for Complex Patients Treated with TAXUS(R) Express2(TM) Stents and Bypass Surgery

... each patient. The analysis of the raw SYNTAX Score data presented today demonstrated that PCI and CABG patients whose scores fell into the lower or intermediate terciles of complexity had similar rates of MACCE (Major Adverse Cardiovascular or Cerebrovascular Event rate, including all-cause death, stroke, MI ...

Video: Large, Multi-Center Trial Demonstrates Comparable Accuracy for Virtual Colonoscopy and Standard Colonoscopy

... findings were evaluated using standard colonoscopy as the reference standard. CT colonography was found to be highly accurate for the detection of intermediate and large polyps. Ninety percent of the polyps 1 centimeter or larger were detected by CT colonography. Even polyps as small as one half centimeter ...

MultiVu Video Feed: Major Trial Demonstrates Comparable Accuracy of Virtual Colonoscopy and Standard Colonoscopy

... of Health (NIH), enrolled more than 2,600 patients at 15 sites nationwide and found that CT colonography was highly accurate for the detection of intermediate and large polyps. For further information about the ACRIN National CT Colonography Trial, please visit: ...

Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C

... therapy for chronic HCV infection. Cohort 1 administered R7128 500mg BID, Cohort 2 administered R7128 1500mg BID, and Cohort 3 administered an intermediate dose of 1000mg BID, all given in combination with pegylated interferon and ribavirin for 28 days. All subjects then went on to receive a total of 48 ...

Diverse Approaches to Alzheimer's Therapies Continue to Show Progress at ICAD

... the lowest persistency group (1st quartile) were 2.4 times more likely to die than those in the highest persistency group (4th quartile). Those with intermediate drug exposure had increased risk of death of 2.2 times (2nd quartile) and 1.5 times (3rd quartile) compared to the most persistent users. More ...

Two New Alzheimer's Disease Studies Show Advances Against Different Treatment Targets

... it becomes necessary to identify patients at the earliest point in the disease. Mild Cognitive Impairment (MCI) is the term used to describe the intermediate state between normal aging and the very earliest features of Alzheimer's, but its frequency in the population is not known. Ronald C. Petersen, MD, ...

Journal of Antimicrobial Chemotherapy Paper Supports Additional Role for Cethromycin as Potential Treatment for Infections Caused by Community- Associated Methicillin Resistant Staphylococcus Aureus (CA-MRSA)

... range of < / = 0.002-1.0 mg/L, with the MBC50 of < / = 0.002 mg/L and the MBC90 of < / = 0.008 mg/L. Of the 170 CA-MRSA isolates, 169 (99.4%) were intermediate or resistant to at least one macrolide. In contrast, 164 (96.5%) isolates were susceptible to clindamycin. Only six (3.5%) isolates demonstrated ...

Vion Pharmaceuticals Announces Presentation of Data of Cloretazine(R) (VNP40101M) in Elderly Patients with High-Risk Myelodysplastic Syndromes at the EHA Annual Meeting

... diagnosed with RAEB-t. Five patients were diagnosed with either chronic myelomonocytic leukemias (CMML) (3) or as unknown (2). Fifteen patients had intermediate cytogenetics and 11 had unfavorable cytogenetics. Sixteen of the patients were classified as Intermediate-2 risk by the International Prognostic ...

New Data From Head-to-Head Study Confirms Once-Daily Levemir(R) is as Effective as Glargine over a 24-Hour Period in Subjects with Type 2 Diabetes

... Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir from other intermediate or long-acting insulin preparations. The dose of Levemir may need to be adjusted in patients with renal or hepatic impairment. Prescribing ...

DURABLE Clinical Trial Results Show GlycoMark is Key Test for Managing Patients with Diabetes

... aspart 30 and insulin glargine. Reference: Diabetic Medicine 2008 (Alan Moses) About GlycoMark GlycoMark is an FDA approved test for monitoring intermediate glycemic control by measuring the levels of a monosaccharide 1,5-anhydroglucitol (1,5- AG) in blood. Multiple published studies in peer-reviewed ...

Preliminary Analyses from Phase 2 Genzyme Study Highlight Efficacy and Safety of Clofarabine in Older Adult AML Patients

... factors: age greater than or equal to 70, pre-existing hematological disorder such as myelodysplastic syndrome (MDS), poor health performance, or intermediate or unfavorable cytogenetics. Patients also had to be previously untreated and unlikely to benefit from conventional induction chemotherapy (7+3 ...

Genomic Health Announces Results of Initial Studies to Develop Predictive Tests for Targeted Therapies

... in patients with hormone receptor positive disease who had an Oncotype DX Recurrence Score(TM) result greater than 18 (i.e., who were classified as intermediate risk of recurrence or above), a number of candidate genes strongly predicted benefit from treatment with docetaxel (Taxotere), a type of taxane ...

Sunesis Pharmaceuticals Initiates Phase 2 Clinical Trial of Voreloxin (SNS-595) in Acute Myeloid Leukemia

... patients must be at least age 60 with previously untreated AML and satisfy at least one of the following factors: poor performance status (PS 2); intermediate or unfavorable cytogenetics; prior antecedent hematologic disorder; or age greater than or equal to 70 years. Patients enrolled in the trial will ...

AviaraDx Confirms That Combination of Two Molecular Biomarkers Improves Prediction of Disease Recurrence in Early Stage Breast Cancer Patients

... The clinical data published this month demonstrate that Aviara MGI accurately identifies Grade 1 and 3 tumors, and successfully re-classifies intermediate tumor grade (Grade 2) into cases with Grade 1-like or Grade 3-like outcomes. "The importance of accurate tumor grading cannot be understated," ...

iCAD Announces Partnership for Initiating Clinical Testing of Its Virtual Colonoscopy CAD Product

... several national trials including the National CT Colonography Trial that recently demonstrated that CTC is highly accurate for the detection of intermediate and large polyps and that the accuracy of CTC is similar to colonoscopy. About ACR Image Metrix ACR Image Metrix is a subsidiary of the American ...

Phase II Study of Zevalin(R) Consolidation Following Fludarabine and Mitoxantrone Chemotherapy Results in 100 Percent Complete Remission Rate and 89 Percent Three-Year Progression Free Survival in Patients with Previously Untreated Non-Follicular Indolent

... (16 patients). "This single arm, non-randomized phase II trial provides additional insights into the potential utility of RIT in intermediate grade NHL, a subtype where CRs are infrequent with rituximab therapy," noted Jack W. Singer, M.D., Chief Medical Officer of CTI. The study results ...

10 Million Square Feet of Turf Set to be Treated in 2008 in Response to MRSA Outbreaks Nationwide

... the NFL's New England Patriots, Minnesota Vikings, Cleveland Browns; the University of South Carolina and University of Tulsa; and the entire Plano intermediate School District in Texas. TurfAide made headlines in 2007 when the exclusive provider of AstroTurf(R) USA, General Sports Venue, made the choice to ...

Genzyme Completes Enrollment in Pivotal, Phase 2 Clinical Trial of Clofarabine in Adult AML

... factors: age greater than or equal to 70, prior hematological disorder such as myelodysplastic syndromes (MDS), poor health performance, or intermediate or unfavorable cytogenetics. The primary endpoint is overall remission rate measured as either complete remission or complete remission with ...

Patient Enrollment Complete in First Trial to Compare Physiologic Guidance vs. Angiographic Guidance of Stent Deployment in Patients with Multivessel Disease

... often in patients with increasingly complex CAD, including multivessel disease," said Dr. De Bruyne. "Furthermore, some physicians are stenting all intermediate lesions with DES regardless of the physiologic significance of those lesions. DES are expensive and have been associated with potential late ...

Feeling Anxious or Distracted? New Research Shows a Cup of Tea Could Help

... tea flavonoids provide support for cardiovascular health by promoting healthy endothelial function. In his studies, subjects were given either low, intermediate or high doses of tea flavonoids and then the researchers measure endothelial dysfunction via flow-mediated dilation of the brachial artery and ...

Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years

... for combination therapy over monotherapy during the first 12 months of treatment." CombAT Two-Year Results The findings reported today are intermediate results from a study that remains active. Researchers will issue a final report at the end of four years regarding the efficacy of AVODART, ...

Callisto Reports on Second-Quarter 2007 Milestones

... Phase II clinical trial in neuroendocrine carcinoma is a multiple-center, open-label study of the safety and efficacy of Atiprimod in low to intermediate grade neuroendocrine carcinoma patients. The trial, designed to enroll 40 patients, presently has 29 patients on study, and Callisto anticipates ...

Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients

... for this Phase II clinical trial. The primary objective of the Phase II clinical trial is to evaluate efficacy of Atiprimod in patients with low to intermediate grade neuroendocrine carcinoma who have metastatic or unresectable cancer and who have progression of their disease despite standard therapy ...

Oncophage Cancer Vaccine Significantly Prolongs Recurrence-Free Survival by 45 Percent in Patients With Intermediate-Risk Kidney Cancer

... collection, showed that in a substantial subset of patients (n = 362) at intermediate risk for disease recurrence, Oncophage demonstrated a clinically ... is defined by the Eastern Cooperative Oncology Group (ECOG) as at intermediate risk for disease recurrence*. Although the median survival has not yet ...
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