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Criteria in Medical Technology

Peregrine Pharmaceuticals Highlights Promising Early Data From Its Three Phase II Bavituximab Cancer Trials

... in All Three Studies Surpassed Pre-Established criteria for Expansion of Patient Enrollment - - ... second larger cohort of patients if pre-specified criteria are met. All three trials surpassed the criteria for expanding enrollment to the second cohort. ...

Perceptive Informatics Enhances Investigator Application of New RECIST Version in Imaging-Based Oncology Trials

... new 1.1 version of RECIST (Response Evaluation criteria In Solid Tumors) in medical imaging-based ... with respect to incorporation of the RECIST criteria into Independent Review Charters for regulatory ... at the forefront of incorporating the new RECIST criteria into medical imaging services to meet immediate ...

Certification Commission for Healthcare Information Technology to Develop Dermatology-Specific Functionality Criteria for Electronic Health Record (EHR) Technology

... New criteria to Help Facilitate EHR Adoption in Small, ... will develop dermatology-specific functionality criteria beginning in 2009. The CCHIT's decision was in ... functionality, interoperability and security criteria for primary care, child health, and cardiology. ...

New Analysis Estimates Numbers of Older U.S. Adults Who May Benefit From Statin Therapy

... therapy based on their matching the inclusion criteria used in a recently published clinical trial, ... and those who might be eligible based on the criteria proposed in JUPITER," said the study's lead ... be recommended a statin therapy if those criteria were adopted into guidelines." The study is ...

Jennerex Publishes Clinical Trial Data With Lead Product JX-594 Demonstrating Efficacy Against Liver Cancer and Associated Hepatitis B Virus

... were achieved in evaluable patients by objective criteria including RECIST (Response Evaluation criteria in Solid Tumor) (response in 30 percent of ... disease in 60 percent of patients) and Choi criteria (response in 80% of patients). Tumor ...

Jennerex Publishes Promising Results from Cancer Clinical Trial of JX-594 in Lancet Oncology

... were achieved in evaluable patients by objective criteria including RECIST (Response Evaluation criteria in Solid Tumor) (response in 30 percent of ... disease in 60 percent of patients) and Choi criteria (response in 80% of patients). Tumor ...

Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment

... those patients who do not meet the aforementioned criteria -- will not be enrolled in this study. In this study, in the 36-week treatment arm, RVR criteria at 4 weeks of boceprevir treatment (treatment ... at week 36. Patients who do not meet the RVR criteria will stop boceprevir treatment at week 36 and ...

Everolimus (RAD001) Significantly Extends Progression-Free Survival in Advanced Kidney Cancer Patients After Failure of Other Targeted Therapy

... Sloan- Kettering Cancer Center (MSKCC) risk criteria and prior anti-cancer therapy. MSKCC risk criteria are standard clinical criteria to determine the prognosis of patients with RCC. ...

Study Shows Need to Test More COPD and Asthma Patients for Underdiagnosed Pulmonary Disease

... COPD Day, Physicians Urged to Use Wider Screening criteria for Alpha-1 Antitrypsin ... undiagnosed or misdiagnosed due to screening criteria and practices." The study, conducted by the ... that if pulmonologists rely on standard screening criteria for Alpha-1 testing, the result will be incorrect ...

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

... responders needed to satisfy the pain composite criteria as well as demonstrate at least a 6-point ... MLN-MD-02 met the composite syndrome responder criteria (25% and 26% for the milnacipran 100 mg and ... FMS-031 also met the composite syndrome responder criteria at three months (33% and 33% for the ...

Fate Therapeutics Announces First Patient Treated in Phase 1b Clinical Trial of FT1050 for Hematopoietic Stem Cell Support

... blood units are readily available from cord blood banks, and the matching criteria for cord blood are less stringent than with adult donors, the ability to ... Finding an unrelated donor match is limited by stringent matching criteria and is extremely difficult for ethnic populations, and delays in finding a ...

Final Results of Boceprevir Phase II HCV SPRINT-1 Study Showed Significantly Higher SVR Rates Compared to Standard of Care in Treatment-Naive Genotype 1 Hepatitis C Patients

... clinical program individualizes treatment based on response, utilizing RVR criteria at week 4 of boceprevir treatment to determine overall duration of ... enrolled a total of 404 patients. In both registration studies, RVR criteria at 4 weeks of boceprevir treatment (treatment week 8) is used to determine ...

Diabetes Patients with High Triglycerides and Low HDL Cholesterol Get the Most Benefit From Fenofibrate Treatment: New Data From the FIELD Study

... triglyceride (greater than or equal to 1.7 mmol/L-150mg/dL ) are key criteria of the metabolic syndrome according to the old definition of the US ... In the FIELD study over 80% of patients met the NCEP ATPIII criteria for metabolic syndrome. This latest study from FIELD investigated ...

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

... The primary efficacy endpoints were the proportion of subjects meeting criteria as composite responders based on one of two definitions. In the first ... a greater proportion of patients treated with milnacipran met the criteria for a treatment response as measured by concurrent improvements in pain, ...

New Study Demonstrated ACTEMRA(R) (tocilizumab) Inhibited Progression of Joint Damage in Rheumatoid Arthritis Patients

... the signs and symptoms of RA and achieved remission according to the DAS28 criteria more often than with DMARDs," said Kenneth Bahrt, M.D., Global Medical ... (3.2 5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology. (4) The Health Assessment ...

ACTEMRA (R) (tocilizumab) Significantly Reduced Signs and Symptoms of Rheumatoid Arthritis in Patients Who Failed Prior Treatments

... (3.2 5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology. (3) The EULAR response criteria is based on the individual amount of change in DAS and the DAS value (low, ...

MacroChem Announces Phase 2 Data for EcoNail(R) in the Treatment of Onychomycosis

... in uninvolved (clear) nail area. While none of the 37 patients reached all criteria of the composite primary endpoint, the consensus judgment of the panel ... at three U.S. sites and included efficacy assessments using standard criteria of nail appearance and mycology. This trial was specifically designed, ...

ABC News NIGHTLINE Features HIFU with Sonablate(R) 500 as Non Invasive Treatment Option for Prostate Cancer

... of prostate cancer," Lepor added. If patients meet the enrollment criteria they may qualify to enroll in the U.S. HIFU clinical trials. For more information about the clinical trials eligibility criteria call USHIFU at 1-877-874-4389. "HIFU offers non invasive treatment ...

Trubion Pharmaceuticals Announces Presentation of Positive TRU-015 and SBI-087 Data at the 2008 Annual European Congress of Rheumatology Meeting

... produce persistent responses on the American College of Rheumatology (ACR) criteria and consistent pharmacodynamic (PD) effects. In addition, preclinical ... with RA. This Phase I trial is designed to enroll patients who meet the criteria for RA with Functional Class I, II or III, and who have been diagnosed ...

ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies

... than or equal to 3.2), moderate (3.2 (DAS28>5.1). DAS28 the criteria of the American College of Rheumatology. (3) The EULAR response criteria is based on the individual amount of change in DAS and the DAS value ...

ADVENTRX Presents CoFactor Data at the 2008 Annual Meeting of the American Society of Clinical Oncology (ASCO)

... is assessing objective response rate as defined by Response Evaluation criteria in Solid Tumors (RECIST) criteria. RECIST criteria is a series of formalized rules for the measurement of tumor target ...

Further Clinical Testing of BZL101 in Advanced Breast Cancer Demonstrates Favorable Efficacy and Toxicity Profiles

... toxicity and tumor response as defined by RECIST (Response Evaluation criteria In Solid Tumors), a set of published criteria that determine when a tumor responds, remains stable or progresses. The ...

International ACTEMRA Rheumatoid Arthritis Study Highlighted in The Lancet

... (3.2 5.1). DAS28 corresponds to being in remission according to the criteria of the American Rheumatism Association (ARA). (3) The EULAR response criteria is based on the individual amount of change in DAS and the DAS value ...

Wedgewood Introduces Refresh(TM) Exchange-Program: Free Exchange of Expired Veterinary Compounded Medications Solves Key Industry Problem

... from compounded-drug stability data when available or are calculated using criteria established by the United States Pharmacopoeia. Malmberg noted, ... after expiration they can exchange medications that meet the program's criteria by completing a form, enclosing it with the expired medications and ...

Boehringer Ingelheim Initiates NEwArT Study Comparing Viramune(R) (nevirapine) to a Ritonavir-Boosted Atazanavir-based Regimen in Treatment-Naive HIV Patients

... to 200 mg twice daily after two weeks. The current VIRAMUNE CD4+ cell criteria are being applied to both arms of the study. All patients will also ... weeks duration. For additional information on inclusion and exclusion criteria and NEwArT study sites, visit http://www.clinicaltrials.gov . About ...

New Clinical Studies Confirm Mauna Kea Technologies' Cellvizio(R) GI in Range of Procedures

... of gastrointestinal (GI) disorders. The findings also provide insight into criteria for optimizing Cellvizio(R) GI performance. The UEGW meeting is taking ... a prospective blinded study has been initiated to evaluate and define criteria for use of Cellvizio(R) GI in diagnosing GI-GVHD. Promising results were ...

New Study of Concerta(R) Showed Significant Improvement of ADHD Symptom Management in Adults Compared to Placebo

... (p=0.029) and change in percent of subjects meeting pre-defined Responder criteria (p=0.009). In the study, 229 patients with ADHD aged 18-65 years were ... Corporation. (a) Three patients not meeting study inclusion/exclusion criteria were randomized to CONCERTA but did not receive study medication and ...

Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA

... sizes, and nominally significant improvements were observed in liver size at this dose. Results were clinically important as defined by standard criteria and consistent with the previously published Phase I/II data. At the 45 U/kg IV dose, statistically significant improvements in hemoglobin, ...

FDA Issues Complete Response Letter for INTUNIV(TM) (guanfacine) Extended Release for the Treatment of ADHD in Children and Adolescents

... this syndrome.(12) Adequate diagnosis requires the use of medical and special psychological, educational, and social resources, utilizing diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV(R)) or International Classification of Diseases 10 (ICD-10).(12,17,18) ...

International Journal of Occupational and Environmental Health Features Discovery of Asbestos-Related Pain Origin from Scientists at the Karmanos Cancer Institute in Detroit

... CT findings, the physical examination, pulmonary function studies, epidemiology and history of the patient's intractable pleural pain meets the criteria for diagnosis of asbestosis. Combined with the known science of taconite dust, a link between the mine where the patient's father worked and the ...

Spherix Announces Positive Phase 2 Study Results

... Naturlose was administered orally with meals (TID) at three different doses, 2.5, 5.0, and 7.5 g. Patients were required to pass specific inclusion criteria at screening and at baseline, including an HbA1c level at screening and baseline between 6.6% and 9.0%. The baseline visit followed an 8-week run-in ...

CuraGen Announces Expansion of CR011-vcMMAE Phase II Trial in Advanced Breast Cancer

... ) announced today that its Phase I/II Trial evaluating CR011-vcMMAE for the treatment of patients with advanced breast cancer has met the efficacy criteria for advancement to the second stage of enrollment. To date, 29 patients have been enrolled in this trial, including 15 in the Phase II portion. Two ...

CRi Oosight(TM) Instrument Crucial in IVF Breakthrough Demonstrating a Correlation Between Non-Invasive Egg Metrics and Pregnancy

... from the School of Women's & Children's Health at the University of New South Wales . The group determined that while absolute predictive criteria for the selection of the best embryo for single-embryo transfer remain elusive, CRi's Oosight instrument provides a useful, non-invasive means to ...

Two-Year Data Show Patients Receiving SIMPONI(TM) (golimumab) Experienced Sustained Improvement in Signs and Symptoms of Psoriatic Arthritis and Ankylosing Spondylitis

... two years. Of the 356 patients originally randomized, 286 were evaluated at two years. Improvements in the Assessment in Ankylosing Spondylitis criteria (ASAS 20) were maintained through two years in each of the study arms: SIMPONI 50 mg after switch from placebo at week 16 (24 of ...

Data Demonstrated ACTEMRA(R) (tocilizumab) Significantly Inhibited Progression of Structural Joint Damage in Rheumatoid Arthritis Patients

... to 3.2), moderate (3.2<DAS28 less than or equal to 5.1) or high (DAS28>5.1). DAS28<2.6 corresponds to being in remission according to the criteria of the American College of Rheumatology. (2) The Genant-modified Sharp score focuses on 14 specific sites for evidence of bone erosion and 13 sites ...

New Heart Ultrasound Research Reveals Life-Saving Treatment Alternatives and Advancements for Heart Patients

... CONDITIONS UNTREATED More than 75 percent of patients studied did not have aortic valve replacement surgery even though they met established criteria Symptoms of severe aortic stenosis are under-diagnosed, preventing patients from receiving potentially life-saving aortic valve replacement ...

Trius Announces Positive Results From Phase 2 Clinical Trial of Torezolid in Patients With Complicated Skin and Skin Structure Infections

... the trial results indicate that oral torezolid successfully treated these severe infections quickly and effectively." "We set strict severity criteria for enrollment to ensure that patients had a clear need for systemic antibiotic therapy," said Philippe Prokocimer, M.D., Chief Medical Officer of ...

SCAI Statement on the BARI 2D Trial (Bypass Angioplasty Revascularization Investigation With Diabetes Trial) Presented at the American Diabetes Association (ADA) Annual Scientific Sessions and Published in The New England Journal of Medicine

... and severity of blockage(s) in the arteries. This is an important point to understand: it is these sicker patients, who did not meet the inclusion criteria for the trial based on the diagnostic angiogram, who receive the greatest life-saving benefits from revascularization. Since the patients studied in ...

Arena Pharmaceuticals Announces Lorcaserin Data Demonstrating Highly Significant Categorical and Absolute Weight Loss and Improvements in Secondary Endpoints Associated with Cardiovascular Risk

... at the end of the study to assess heart valve function over time. In contrast to the BLOOM trial, however, there are no echocardiographic exclusion criteria for entry into these trials and there is no monitoring by an independent board. About Lorcaserin Lorcaserin is a novel single agent that ...

Ironwood and Forest Present Additional Positive Phase 2b Study Results for Linaclotide in Patients With Irritable Bowel Syndrome With Constipation

... The study evaluated the effects of 75, 150, 300, or 600 ug linaclotide or placebo administered orally once daily to adults meeting modified Rome II criteria for IBS-C. Participants underwent a two-week pretreatment (baseline) period before undergoing the 12-week treatment period, followed by a two-week ...
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(Date:11/25/2009)... as vital to your health as what you eat, found re...dies. Their experiments in mice revealed that the ...he liverthe body,s metabolic clearinghouseis mostl...circadian clock as conventional wisdom had it. ,...rge number of genes completely independent of the ...
(Date:11/24/2009)... understanding how sounds associated with Navy son... if they hear it at all. , The same type of larg...o detect flaws in the space shuttle,s behemoth sol... inside the giant head of a whale. The scans are p...whale,s hearing anatomy using a breakthrough metho...
(Date:11/24/2009)...e class of ring-shaped protein motors has been unc...ational Laboratory (Berkeley Lab) using a state-of...dvanced Light Source (ALS). These protein motors p...on, and are vital to the survival of all biologica... human papillomavirus, which has been linked to ce...
Breaking Biology News(10 mins):Feeding the clock 2Feeding the clock 3Rocket science leads to new whale discovery 2Atomic-level snapshot catches protein motor in action 2Atomic-level snapshot catches protein motor in action 3Atomic-level snapshot catches protein motor in action 4PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice 12443 1PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice 12443 2PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice 12443 3Want to Stop Cancer 3F You Can Experts Say 47763 1Want to Stop Cancer 3F You Can Experts Say 47763 2Want to Stop Cancer 3F You Can Experts Say 47763 3PDI and The Medical Affairs Company Enter Exclusive Strategic Alliance 12442 1PDI and The Medical Affairs Company Enter Exclusive Strategic Alliance 12442 2PDI and The Medical Affairs Company Enter Exclusive Strategic Alliance 12442 3
(Date:11/26/2009)...Dental (RTDental), a leading dental group practice...pansion of its services to include LUMINEERS by a ... , Durham, NC (PRWEB) -- ...at Dr. Doug Macmillan, an experienced LUMINEERS ... training seminar. RTDental’s ability to fu...
(Date:11/25/2009)...wire/--WhenmostpeopleheartheacronymTMJ,theythinkof...ehelptheyneed.TMJstandsfortheTemporal-MandibularJo...withyourskull(temporalbone). ,, Themostcommonsy...ng,clickingorpoppingofthejaw.Butmanyothersymptomsc...tigue,sleepdisturbances,irritability,alossinfocus,...
(Date:11/25/2009)...-SentinelleMedicalInc.,aleadingmanufacturerofMagne...ScientificInc.,aleadingproviderofsoftwareenablingt...east4DAdvancedVisualizationsoftware. ,, Thisinn...ientbasedmedicalimagingofferinginthemarket.Calgary...rintaccess-requiringnosoftwaredownload,andrunsonan...
(Date:11/25/2009)...SNewswire/--AnarticlebyJanetWoodcock,M.D.,director...d"ADifficultBalance-PainManagement,DrugSafety,andt...JournalofMedicine. ,, (Logo: http://www.newscom...ticle,WoodcockdiscussesFDAeffortstostrikeabalanceb...nagingtherisksposedbyvariousanalgesics.Asexamples,...
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Breaking Medicine News(10 mins):Health News:Dr. Douglas Macmillan Now Providing LUMINEERS at Research Triangle Dental 2Health News:Sentinelle Medical Inc. Introduces Aegis(TM) Web Powered By Calgary Scientific's PureWeb Technology 2Health News:Sentinelle Medical Inc. Introduces Aegis(TM) Web Powered By Calgary Scientific's PureWeb Technology 3Health News:First Time-Door is Open for Family Discussion of Bipolar Disorder 2Health News:First Time-Door is Open for Family Discussion of Bipolar Disorder 3
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