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Composite in Medical Technology

Schering-Plough Announces Results of the Early ACS Trial

... use. The primary efficacy endpoint was a composite of death, (re)infarction (MI), recurrent ischemia ... patients experienced fewer primary and secondary composite events after PCI than those randomized to the ... daily. The primary efficacy endpoint was a composite of all-cause mortality, (re)MI, recurrent ...

Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

... used as an alternative to the validated composite Pelvic Signs and Symptoms Scale (CPSSS), require ... treatment arms were superior to placebo on a composite of the FDA-suggested daily scales (total score ... suggests that changes in the exploratory FDA composite scale is clinically relevant in women with ...

Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study

... dose. The primary endpoint of the trial is the composite of cardiovascular death, MI, urgent coronary ... or stroke. The key secondary endpoint is the composite of cardiovascular death, MI or stroke. Patients ... endpoint of the Phase III TRA-CER trial is the composite of cardiovascular death, MI, rehospitalization ...

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

... by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated, ... from baseline as compared to placebo in nighttime composite symptom scores, and daytime composite symptom scores, both comprised of cough, ...

Milnacipran Demonstrated Significant Improvement in Pain and the Core Symptoms of Fibromyalgia Syndrome, Data Show

... effectiveness has been evaluated utilizing a composite responder approach which requires, on a ... across multiple FMS domains. As such, composite responder analyses represent a more ... To be considered a responder for the composite "pain of fibromyalgia" endpoint, each patient had ...

SCH 530348 (TRA), a Novel Investigational Antiplatelet Agent, Shown to Inhibit Platelet Aggregation in PCI Patients

... or stroke. The key secondary endpoint is the composite of cardiovascular death, MI or stroke. Patients ... endpoint of the Phase III TRA-CER trial is the composite of cardiovascular death, MI, rehospitalization ... or stroke. The key secondary endpoint is the composite of cardiovascular death, MI or stroke. Patients ...

Fifth U.S. Hand Transplant Patient Heads Home to NY

... tendon, bone, cartilage, fat, nerves and blood vessels) and is called composite tissue allotransplantation. A partnership of physicians and ... of Naval Research and Office of Army Research to further research in the composite tissue allotransplantation program. Information, photography and ...

Kleinert Kutz Hand Surgeons Perform Fifth U.S. Hand Transplant in Record Time at Jewish Hospital Hand Care Center

... tendon, bone, cartilage, fat, nerves and blood vessels) and is called composite tissue allotransplantation. "The fifth hand transplant went ... of Naval Research and Office of Army Research to further research in the composite tissue allotransplantation program. Information, photography and ...

Abbott's XIENCE V(TM) Drug Eluting Stent Outperforms TAXUS(R) in Key Efficacy and Safety Endpoints Out to Two Years

... percent for XIENCE V vs. 14.7 percent for TAXUS, p-value=0.03)*. TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac death, ... XIENCE V vs. 12.3 percent for TAXUS, p-value=0.001). MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as ...

TAXUS OLYMPIA Registry Shows Excellent Outcomes for High-Risk Patients Treated With Second-Generation TAXUS(R) Liberte(R) Stent

... demonstrated a low overall 3.8 percent rate of TAXUS Liberte stent-related composite cardiac events, including cardiac death (1.2%), MI (0.8%), and ... more complex expanded use patient population, the rates of stent-related composite cardiac events and stent thrombosis were 4.3 percent and 0.9 percent ...

TRANSCEND(TM) Trial Results Presented at European Society of Cardiology Congress and Published in The Lancet

... investigated Micardis(R) (telmisartan) against placebo in reducing the composite endpoint of cardiovascular death, myocardial infarction, stroke and ... receiving current standard of care resulted in an 8% reduction in the composite endpoint of cardiovascular death, myocardial infarction, stroke and ...

Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Association Meeting

... of clinical benefit involves the use of one of the many available composite scoring systems. These include the Total Neuropathy Score (TNS) and the ... of vibration and electrophysiological testing. A total neuropathy composite score (TNS) will also be computed to evaluate changes in nerve health. ...

XIENCE(TM) V Drug Eluting Stent from Abbott Outperforms Market-Leading Stent in Reducing Major Adverse Cardiac Events at Two Years

... V vs. 12.8 percent for TAXUS, p-value=0.004)*. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined ... for XIENCE V vs. 15.4 percent for TAXUS, p-value=0.04)*. TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac ...

Medarex Announces Initiation of Phase 2 Clinical Trials for the Treatment of Ulcerative Colitis and Rheumatoid Arthritis

... response rate at 8 weeks. Clinical response is based on the Mayo score, a composite endpoint that assesses stool frequency and the amount of bloody stool per ... in Europe. The primary endpoint of the study is the ACR20 response, a composite endpoint that indicates a 20% improvement in RA signs and symptoms, at 12 ...

Study in JAMA Shows Patients Treated With Abbott's XIENCE(TM) V Drug Eluting Stent Experience Better Outcomes Than Patients Treated With Market-Leading Drug Eluting Stent

... TAXUS (7.2 percent for XIENCE V vs. 9.0 percent for TAXUS). TVF is a composite clinical measure of safety and efficacy outcomes defined as cardiac ... 10.3 percent for TAXUS) compared to TAXUS. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined ...

Lotrel, a Single-Pill Combination for Treating High Blood Pressure, Reduced Cardiovascular Events by 20% in High-Risk Patients

... of commonly used high blood pressure medicines in the reduction of a composite endpoint including heart attacks, strokes, hospitalizations for unstable ... the maximum dose of study medications. The primary study endpoint was a composite of cardiovascular disease, non- fatal heart attack, non-fatal stroke, and ...

Amgen Announces Positive Top-Line Results for Denosumab in Trial for Delay of Skeletal Related Events in Bone Metastases Patients Compared to Zometa(R)

... or SREs, caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies use a composite endpoint of four SREs - fracture, radiation to bone, surgery to bone, and spinal cord compression - to measure the effectiveness of denosumab versus ...

Denosumab Demonstrates Superiority Over Zometa(R) in Pivotal Phase 3 Head-to-Head Trial in Breast Cancer Patients With Bone Metastases

... or SREs, caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies use a composite endpoint of four SREs - fracture, radiation to bone, surgery to bone, and spinal cord compression - to measure the effectiveness of denosumab versus ...

MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type 1 Diabetes

... within 12 weeks of their diagnosis. More than 530 individuals are enrolled in the study across 14 countries, including the United States. The primary composite endpoint for PROTEGE includes both the patient's total daily insulin usage and his/her HbA1c levels at 12 months. Secondary endpoints are evaluated ...

Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program

... and long-term treatment of patients with edema associated with either primary or metastatic brain tumors. The primary endpoint of this study was a composite of three factors during weeks two through five: a 50 percent reduction in dexamethasone, stable or improved Karnofsky performance status and stable ...

Induction Chemotherapy Followed by ChemoRadiotherapy Increased Time-to-Treatment Failure Compared to ChemoRadiotherapy Alone in Patients With Unresectable Locally Advanced Head & Neck Cancer

... (TTF) for patients with unresectable Locally Advanced Head and Neck Cancer (LAHNC). The endpoint of Time-to-Treatment Failure was defined as a composite of time-to-disease progression, -to-surgery or other cancer-related treatments, -to-drop-out due to an adverse event, and to death from any cause. ...

Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types

... receiving Femara had clinically and significantly better overall cognitive function than the patients in the tamoxifen group (difference in mean composite scores =0.23, P=0.04, 95% confidence interval: 0.02-0.54). Overall, both groups performed below age norms on most domains(6). Highlights in ...

Kensey Nash Announces Presentations on its Cartilage Repair Device at the International Cartilage Repair Society Meeting

... by providing a device with the requisite biomechanical and biological properties for promoting osteochondral repair," he concluded. The CRD is a composite of several resorbable biomaterials, utilizing the Company's proprietary collagen technology, and beta-tricalcium phosphate mineral suspended in a ...

Medarex Announces Primary Endpoint Achieved in MDX-1100 Anti-IP-10 Antibody Phase 2 Trial for Rheumatoid Arthritis

... two weeks for a total of four doses. The primary endpoint of the study is response rate at 8 weeks. Clinical response is based on the Mayo score, a composite endpoint that assesses stool frequency and the amount of bloody stool per day as recorded in a patient diary, physician global assessment and the ...

Anthera's Varespladib Meets Primary Endpoint in Phase 2 FRANCIS Trial for the Treatment of Acute Coronary Syndrome

... insight into the potential prevention of secondary Major Adverse Cardiovascular Events (MACE) by varespladib. In this study, MACE was defined as a composite endpoint consisting of all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, unstable angina, and a subset of revascularization ...

New Imaging Analysis Predicts Brain Tumor Survival

... magnetic resonance imaging, or MRI, protocol to monitor changes over time in tumor blood volume within individual voxels of the image, rather than a composite view of average change within the tumor. This parametric response map allowed researchers to see specific areas in which tumor blood volume increased ...

Clinical Data Reinforce Safety and Efficacy of Boston Scientific's Two Drug- Eluting Stent Platforms

... for TAXUS Liberte in Europe." Three-year data from the SPIRIT II Trial demonstrated that overall Major Adverse Cardiac Events (MACE), a composite endpoint, favored the PROMUS (XIENCE V) Stent compared to the TAXUS Stent (6.4% vs. 14.9% respectively, p=0.029), while the individual components of ...

Impulse Dynamics Announces Pivotal Results at the American College of Cardiology Annual Meeting Late-Breaking Session

... term effects in the largest randomized study to date. The study met its primary safety endpoint, which was a noninferiority demonstration of the composite of all-cause mortality and all-cause hospitalizations. In terms of efficacy, the results showed that, compared to the control group, patients ...

Abbott's Market-Leading XIENCE V(R) Shows Increasing Clinical Advantages Over TAXUS(R) Express2(TM)/TAXUS(R) Liberte(TM) Between Two and Three Years

... increased approximately 40 percent between two and three years (10.5 percent at two years vs. 14.9 percent at three years)*. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, heart attack (myocardial infarction or MI), or ...

Abbott Advances Its Revolutionary Fully Bioabsorbable Drug Eluting Stent With Initiation of Next Phase of Clinical Trial

... (MACE) between six months and two years, with the bioabsorbable device demonstrating a MACE rate of 3.6 percent (one patient) at two years. MACE is a composite clinical measure of safety and efficacy outcomes, defined as any event that resulted in re-treatment of the treated artery lesion (ischemia-driven ...

Applying Clinical Findings to the Practice of Medicine

... - one for contained defects, which are holes contained within the bone, and another for segmental defects, which are gaps between bones. The composite biomaterial, consisting of polymers, metals, ceramics, drugs and biologics, used in either clinical strategy induced bone regeneration by providing ...

Kensey Nash Announces IDE Submission for Cartilage Repair Device

... achieving full commercialization of this proprietary product and technology," he concluded. The Company's Cartilage Repair Device (CRD) is a composite of several bioresorbable biomaterials, utilizing the Company's proprietary collagen technology, and beta-tricalcium phosphate mineral suspended in a ...

AstraZeneca's Partner, MAP Pharmaceuticals, Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints

... treatment of children with asthma did not meet its co-primary endpoints: asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated when compared with placebo. AstraZeneca (NYSE: AZN ) will work with MAP Pharmaceuticals to ...

Data from Phase 2 Study of Peramivir in Patients Hospitalized with Influenza Presented at the XI International Symposium on Respiratory Viral Infections

... who required hospitalization related to influenza. The primary objective of the study was to evaluate time to clinical stability, which is a composite endpoint comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of ...

New England Journal of Medicine Publishes Results From the Landmark ATHENA Trial with Multaq(R) (dronedarone) in Atrial Fibrillation

... placebo, with a mean follow-up of 21 months. The ATHENA study objectives were designed to show a potential benefit of dronedarone on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization compared with placebo. The pre-specified secondary endpoints were death ...

Circulation Publishes Pivotal Two-Year Results On XIENCE V(TM) Drug Eluting Stent

... percent reduction in the risk of MACE compared to TAXUS (7.3 percent for XIENCE V vs. 12.8 percent for TAXUS, p-value=0.004)*. MACE is an important composite clinical measure of safety and efficacy outcomes for patients, defined as cardiac death, MI or ischemia-driven target lesion revascularization (TLR ...

Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Management of Fibromyalgia

... stable-dose treatment phase, and a 2-week discontinuation phase. The primary efficacy endpoints were the proportion of subjects meeting criteria as composite responders based on one of two definitions. In the first co-primary analysis, a patient had to demonstrate simultaneous improvements on both their ...

Dronedarone (Multaq(R)) Reduced the Incidence and Duration of Hospitalization in Patients with Atrial Fibrillation

... BID or placebo, with a maximum follow-up of 30 months. The ATHENA study objectives were to show a potential benefit of dronedarone on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization as compared to placebo. The pre-specified secondary endpoints were death ...

Chemstar Corporation Announces a New Powerful, One-Step Product That Effectively Controls Listeria, Salmonella, E. coli and Fly Larvae in Floor Drains

... overlooked or ignored is floor drains." Schurman goes on to cite: "Floor drains are a specific problem area in the food industry because they are a composite of a room's environment. Drains can easily collect and trap organic soils and bacteria, creating a cool, moist harborage for rapid growth of ...

Further Analysis From ATHENA Study Showed That Multaq(R) (dronedarone) Reduced the Risk of Stroke in Patients With Atrial Fibrillation

... mg BID or placebo, with a maximum follow-up of 30 months. The ATHENA study objectives were to show a potential benefit of Multaq(R) on the primary composite endpoint of all-cause mortality combined with cardiovascular hospitalization as compared to placebo. The pre-specified secondary endpoints were death ...
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(Date:7/11/2014)... de Janeiro, Brazil- In the brains of all ... that allows an electric or chemical signal to ... Chemical synapses, which are the most abundant type ... Synapse formation is crucial for learning, memory, perception ... inhibitory synapses critical for brain function. For ...
(Date:7/10/2014)... June 27, 2014  The American Academy of ... of Standards and Technology (NIST) and the Department ... research and forensic science expert members to the ... an element of the NIST,s Organization of Scientific ... the first appointments made to the new FSSB ...
(Date:7/10/2014)... Mass. , June 30, 2014  Aware, Inc. ... biometrics software and services, previously announced on June 26, ... special cash dividend of $1.75 per share, or approximately ... date of July 10, 2014 and a payment date ... by NASDAQ that it had set an ex-dividend date ...
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