Spontaneous in Medical Technology

Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results

... the change from pre-treatment in weekly spontaneous bowel movement (SBM) frequency. During the ... significant improvements in complete spontaneous bowel movement (CSBM) frequency, ... of life were assessed. Glossary of Terms spontaneous bowel movement (SBM): An SBM is a bowel movement ...

Microbia and Forest Laboratories Announce Preliminary Results of Linaclotide Phase 2b Studies

... was the change from pre-treatment in weekly spontaneous bowel movement (SBM) frequency rate. During the ... in all other top-line efficacy endpoints-complete spontaneous bowel movement (CSBM) frequency, ... function measurements included the number of spontaneous and ...

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

... linaclotide dose levels, the change from baseline vs. placebo for complete spontaneous bowel movement (CSBM) frequency-the study's primary endpoint-was ... more pronounced (-0.8 to -1.3 v -0.2; p = 0.0236 to <0.0001). Results for spontaneous bowel movement (SBM) frequency, stool consistency, straining, abdominal ...

Prasugrel Significantly Reduced New or Recurrent Heart Attacks in Both Acute and Longer-Term Settings Following PCI, Compared with Clopidogrel

... according to the ESC Universal Definition of Myocardial Infarction as spontaneous (Type 1) or procedure-related (Type 4 or 5).(1) The analysis showed that ... are registered trademarks of sanofi-aventis. P-LLY 1. Type 1: spontaneous myocardial infarction related to ischemia due to a primary coronary event ...

Sugammadex Trials Demonstrate Rapid Recovery from Profound Neuromuscular Blockade During General Anesthesia

... Spectrum, faster recovery from profound neuromuscular blockade compared to spontaneous recovery was demonstrated.(2) The pivotal Signal trial results were ... blocking agents (NMBAs). Reversal of neuromuscular blockade enables spontaneous breathing to recommence earlier which helps to get patients out of the ...

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

... the safety, efficacy, and dose response of linaclotide in patients with IBS-C. The primary efficacy endpoint was change from baseline in complete spontaneous bowel movement (CSBM) frequency. The study evaluated the effects of 75, 150, 300, or 600 ug linaclotide or placebo administered orally once daily to ...

Novexel to Present Four Posters at the 19th European Congress of Clinical Microbiology and Infectious Diseases in Helsinki

... was active in vitro against both community-acquired and hospital-acquired strains of MRSA. The poster also showed that NXL103 was subject to a low spontaneous frequency of resistance (Poster P 1102). It is Novexel's intention to seek partners for both the NXL104/ceftazidime combination and NXL103 in ...

Taking Folic Acid for a Year Before Pregnancy May Reduce Risk of Preterm Birth

... study in January 2008 during the annual meeting of the Society for Maternal Fetal Medicine. "Preconceptional Folate Supplementation and the Risk of spontaneous Preterm Birth: A Cohort Study" by Bukowski, et al. is available online at ...

Trius Therapeutics Announces Presentations Featuring Torezolid Antibiotic at the 19th European Congress of Clinical Microbiology and Infectious Diseases

... of the novel oxazolidinone TR-700 and linezolid; J. Locke, K. Shaw P 1104 : Characterization of the novel oxazolidinone TR-700 and linezolid spontaneous mutation frequencies and resistance mechanisms in Staphylococcus aureus ; J. Locke, K. Shaw Copies of these posters will be ...

No Causality Found Between Black Cohosh and Liver Problems

... Results of a Randomized Study Presented at ACOG 2009 Annual Meeting Confirming Teschke's Re-evaluation of spontaneous Reports CHICAGO, May 5 /PRNewswire/ -- Black cohosh has been widely used in Europe and also in North America to treat menopausal symptoms ...

Ground-Breaking Combination of All-Oral Agents Demonstrates Potential as Hepatitis C Treatment Regimen

... PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to ...

Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C

... PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to ...

Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients

... Phase III QUASH studies of clevudine for the treatment of chronic hepatitis B (HBV) infection. Pharmasset recently became aware of a number of spontaneous Serious Adverse Event reports and Events of Special Interest in patients receiving clevudine as prescribed therapy for hepatitis B in South Korea. ...

CSL Behring Receives Orphan-Drug Exclusivity for RiaSTAP(TM), First and Only Approved Treatment of Acute Bleeding Episodes in Patients with Congenital Fibrinogen Deficiency

... include excessive bleeding following injury, bruising, bleeding of the umbilical cord at birth and from the site of the umbilical stump in a newborn, spontaneous bleeding and bone, joint or tissue hemorrhage. Diminished concentrations of fibrinogen, also called Factor I (one), limit the body's ability to form ...

Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

... 25 mg once daily and 50 mg once daily. The study achieved a clinically meaningful and highly statistically significant, dose-dependent increase in spontaneous bowel movements (SBMs) from baseline after the first week of NKTR-118 treatment with the 25 mg dose and the 50 mg dose versus placebo (p < 0.01 ...

Sosei and NeuroSolutions Present Further Data on NSL-043/SD118 at the Society for Neuroscience 38th Annual Meeting

... studies and is now ready for Phase II studies. The data presented demonstrate that NSL-043/SD-118 reverses static allodynia and inhibits spontaneous ectopic discharge in the streptozotocin-induced diabetic neuropathy and chronic constriction injury models of neuropathic hypersensitivity and ...

New Study Shows that PEGASYS(R) Regimen Provides Higher Sustained Virological Response Rates for Hepatitis C Patients

... PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to ...

FDA Approves Bayer HealthCare's Kogenate(R) FS Treatment for Routine Prophylaxis in Children with Hemophilia A

... of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately one in 5,000 males born in the United States has hemophilia. About ...

Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference

... results to be presented at the ACG conference affirm this earlier analysis. In this study, the change from baseline vs. placebo for complete spontaneous bowel movement (CSBM) frequency-the study's primary endpoint-was significant at all linaclotide dose levels. Notably, abdominal pain was clinically ...

U.S. FDA Approves Requip(R) XL(TM), the First and Only Oral Once-Daily Non-Ergot Dopamine Agonist for Parkinson's Disease

... the symptoms of Parkinson's disease. These symptoms include tremor (involuntary shaking), rigidity (stiffness), akinesia (lack of movement or loss of spontaneous movement), bradykinesia (slower-than-normal voluntary movements), and problems with walking, balance and posture. More than one million people in ...

Bayer HealthCare Celebrates 20th Anniversary of Kogenate(R) Product Line and 8 Billion IU Milestone at 2008 WFH World Congress

... of hemophilia, is caused by deficient or defective blood coagulation proteins, known as factor VIII. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs. Approximately 400,000 people around the world have hemophilia A. About Bayer ...

CPR Data Debriefing by Hospital Responders Improves CPR Performance and Increases Initial Survival Rate Following Cardiac Arrest

... -- Decreased ventilation rates -- These improvements in CPR performance correlated with an increased rate of initial survival (or "return of spontaneous circulation", also termed "ROSC") in the RAPID group. In recent years, several studies documented that medical professionals were performing ...

PEGASYS(R)/COPEGUS(R) Show Benefit in Hard-to-Treat Latino Population with Hepatitis C

... PEGASYS. Events occurred in patients with few or no reported risk factors for stroke, including patients less than 45 years of age. Because these are spontaneous reports, estimates of frequency cannot be made and causal relationship between interferon alfa-based therapies and these events is difficult to ...

Catalyst Biosciences Selects Drug Development Candidate in Factor VIIa Program for Hemophilia

... potentially life-threatening spontaneous bleeding episodes and substantially prolonged bleeding times upon injury. In cases of severe hemophilia, spontaneous bleeding into muscles or joints is frequent and often results in permanent, disabling joint damage. Hemophilia patients are initially treated by ...

Rexinoid Developed by NuRx Pharmaceuticals Shows Promise in Prevention, Treatment of Lung, Breast Cancer, Paper in Clinical Cancer Research Reports

... study, NRX4204 exhibited dramatic effects in the prevention of the development of lung cancer and in the prevention and treatment of breast cancer in spontaneous models. We have initiated a Phase I clinical trial and intend to pursue the development of this compound as a treatment for both lung and breast ...

Nektar Commences Phase 2 Trial of NKTR-118 (oral PEG-naloxol) Evaluating Efficacy and Safety as Treatment for Opioid-Induced Bowel Dysfunction

... orally once-daily (QD) over a five-week treatment period. The primary efficacy endpoint of the trial will be the increase from baseline in spontaneous bowel movements per week (SBMs per week). Additional endpoints include monitoring of other symptoms of OBD, which will include the Patient Assessment ...

Minimally Invasive Treatment Reduces Shoulder Pain From Tendonitis

... own. Unfortunately, this can take from a few months to several years," Dr. Sconfienza said. "This means the pain could persist for years before its spontaneous resolution." In addition, when untreated calcifications break up, the calcium is not extracted but spreads along the tendon and lodges in the ...

Inspiration Biopharmaceuticals Announces Filing of IND for Novel Recombinant Factor IX Product, IB1001, for the Treatment of Hemophilia B

... of this study, patients will then enroll in one of two trials: a six month Phase 1/2 On Demand trial to document safety and efficacy in treating spontaneous bleeding episodes or a pivotal Phase 2/3 Prophylaxis trial to document safety and efficacy in the prevention of spontaneous bleeding. In addition, ...

Preimplantation Genetic Diagnosis International Society Refutes American Society of Reproductive Medicine Opinion - States Preimplantation Genetic Screening is Beneficial When Performed in Experienced Centers

... that in experienced hands preimplantation genetic screening (PGS) is unequivocally beneficial in patients suffering from translocations, repeated spontaneous abortions, and often in advanced maternal age. It is the opinion of PGDIS as the organization consisting of international experts in this field ...

Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System

... tool in the delivery of emergency hypothermia therapy." Evolving International standards of care recommend that "unconscious adult patients with spontaneous circulation after out-of-hospital cardiac arrest should be cooled to 32 degrees C to 34 degrees C for 12-24 hours when the initial rhythm was ...

CEL-SCI Corporation Releases Letter to Shareholders

... 20th century observation of a New York surgeon, Dr. William B. Coley, that some sarcoma patients who suffered severe bacterial infections underwent spontaneous regression of their tumors. Due to limited knowledge of the immune system, progress in using immunotherapy was very slow. Efforts to treat cancer ...

Data Suggest Cymbalta Reduced Severity of Night Pain in Patients with Diabetic Nerve Pain

... improved sleep interference in these patients.(1,2,3) Data on treatment-emergent adverse events, including reports of somnolence, were collected by spontaneous report, and while spontaneous reporting is the standard practice for evaluating treatments, solicited scales specifically designed for ...

Sosei Announces Successful Completion of AD 923 Pharmacokinetic Study in the USA

... of moderate to severe pain in cancer patients that "breakthrough" their around-the-clock opioid treatments. Each episode may be spontaneous or incidental to an activity. It is estimated that the condition is prevalent in approximately 60% of cancer pain patients across Europe, the US and ...

Palatin Technologies and King Pharmaceuticals Report Data Showing Improvements in Sexual Relationship and Self-Esteem in Patients with Erectile Dysfunction Treated with Bremelanotide

... was higher than the incidence associated with placebo, primarily included nausea, emesis, flushing, blood pressure increase, headache, and spontaneous erection, skin darkening and nasal symptoms. Except for flushing and nasal symptoms, the incidence of adverse events was dose related. The primary ...

OREXIGEN Therapeutics Announces Sustained-Release Formulation of Zonisamide Shows Improved Tolerability When Compared to Immediate Release Formulation

... (SR) formulation of zonisamide. In the study, the SR formulation of zonisamide achieved a significant reduction in the incidence of spontaneous adverse events compared to an immediate release (IR), legacy formulation. Zonisamide SR is a key component in the Company's obesity product candidate ...

Peer Reviewed Journal Article Indicates Repros' Proellex Exhibits Potential for New Approach to the Treatment and Prevention of Breast Cancer

... aromatase inhibitors which inhibit the synthesis of estrogen. Progestins (progesterone like compounds) have been shown to increase the incidence of spontaneous mammary tumors in dogs and mice. Reports from the Women's Health Initiative showed a small but clearly higher risk of breast cancer in women ...