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Study finds Gingko Biloba does not improve cognition in MS patients

 

Results come after 2005 pilot study offered hope that supplement may have offered benefits

 

Portland, Oregon, USA (September 13, 2012) - Many people with multiple sclerosis for years have taken the natural supplement Gingko biloba, believing it helps them with cognitive problems associated with the disease.

 

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FDA approves new multiple sclerosis treatment Aubagio

 

Silver Spring, MD, USA (September 12, 2012) - The U.S. Food and Drug Administration today approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).

 

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Simple tool may help inexperienced psychiatrists better predict violence risk in patients, U-M study finds

 

Without assessment tool, inexperienced psychiatrists less likely to accurately predict violence

 

Ann Arbor, Mich., USA (September 4, 2012) - Inexperienced psychiatrists are less likely than their veteran peers to accurately predict violence by their patients, but a simple assessment checklist might help bridge that accuracy gap, according to new research from the University of Michigan.

Led by psychiatrist Alan Teo, M.D., a Robert Wood Johnson Foundation Clinical Scholar of the University of Michigan, researchers examined how accurate psychiatrists were at predicting assaults by acutely ill patients admitted to psychiatric units.

 

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New long-term antimicrobial catheter developed

 

Spencers Wood, UK (September 4, 2012) - A novel antimicrobial catheter that remains infection-free for up to twelve weeks could dramatically improve the lives of long-term catheter users. The scientists who have developed the new technology are presenting their work at the Society for General Microbiology's Autumn Conference at the University of Warwick.

 

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Revatio (sildenafil)

Drug Safety Communication - Recommendation Against Use in Children

 

Silver Spring, MD, USA (August 30, 2012) - FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH).This recommendation against use is based on a recent long-term clinical pediatric trial showing that: (1) children taking a high dose of Revatio had a higher risk of death than children taking a low dose and (2) the low doses of Revatio are not effective in improving exercise ability. Treatment of PAH in children with this drug is an off-label use (not approved by FDA) and a new warning, stating the use of Revatio is not recommended in pediatric patients has been added to the Revatio labeling.

 

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FDA approves Linzess to treat certain cases of irritable bowel syndrome and constipation

 

Silver Spring, MD, USA (August 30, 2012) - The U.S. Food and Drug Administration today approved Linzess (linaclotide) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. According to the National Institutes of Health, an estimated 63 million people are affected by chronic constipation. Chronic idiopathic constipation is a diagnosis given to those who experience persistent constipation and do not respond to standard treatment. Additionally, an estimated 15.3 million people are affected by IBS. IBS-C is a subtype characterized mainly by abdominal pain and by hard or lumpy stools at least 25 percent of the time and loose or watery stools less than 25 percent of the time.

 

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Nurse Leader Resistance Perceived as a Barrier to High-Quality, Evidence-Based Patient Care

 

COLUMBUS, Ohio (August 28, 2012) - A new national survey of more than 1,000 registered nurses suggests that serious barriers - including resistance from nursing leaders - prevent nurses from implementing evidence-based practices that improve patient outcomes. When survey respondents ranked these barriers, the top five included resistance from nursing leaders and nurse managers - a finding that hasn’t been reported in previous similar studies - as well as politics and organizational cultures that avoid change.

 

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NICE-recommended clinical trial due to start on promising wound healing device

 

London (August 24, 2012) - The first clinical trial resulting from NICE medical technology guidance recommendations is due to start soon on a device to promote wound healing. NICE issued guidance in 2011 strongly encouraging further research on the use of the MIST Therapy system in chronic wounds, comparing it with standard care. The Medical Technologies Advisory Committee's view was that the device shows promise, but there was not yet enough evidence of sufficient quality to enable a recommendation for routine adoption of its use. The forthcoming clinical trial is the first significant output of the capacity that NICE has put in place for facilitating the development of further evidence, stemming from recommendations by NICE medical devices and diagnostics advisory bodies. The trial on the MIST Therapy system will recruit 40 patients with chronic venous leg ulcers, and will be undertaken independently by Cardiff University and Cardiff and Vale University Health Board.

 

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The bottom photo shows a tattoo infected with a nontuberculous Mycobacteria (NTM) bacteria. It is provided courtesy of Matthew J. Mahlberg, M.D., Dermatology Associates of Colorado, Englewood, Colo., and was obtained by Sarah Jackson, MPH, Colorado Department of Public Health and Environment.Tattoo Inks Pose Health Risks

 

Silver Spring, MD, USA (August 23, 2012) - Tempted to get a tattoo? Today, people from all walks of life have tattoos, which might lead you to believe that tattoos are completely safe.

But there are health risks that can result in the need for medical care. The Food and Drug Administration (FDA) is particularly concerned about a family of bacteria called nontuberculous Mycobacteria (NTM) that has been found in a recent outbreak of illnesses linked to contaminated tattoo inks.

 

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Study underscores need to improve communication with moms of critically ill infants

 

Baltimore, MD, USA (August 16, 2012) - Irish playwright George Bernard Shaw once described England and America as two countries separated by a common language. Now research from the Johns Hopkins Children's Center suggests that common language may also be the divide standing between mothers of critically ill newborns and the clinicians who care for them.

The study, published August 16 in the Journal of Perinatology, found that miscommunication was common, and that the most serious breakdown in communication occurred when mothers and clinicians discussed the severity of the baby's condition. Misunderstanding was common even when both the doctor and the mother agreed their conversations went well, suggesting a startling lack of awareness of the problem, the researchers say.

 

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FDA warns of risk of death from codeine use in some children following surgeries

 

Silver Spring, MD, USA (August 15, 2012) - The U.S. Food and Drug Administration today issued a Drug Safety Communication concerning three children who died and one child who experienced a non-fatal but life-threatening case of respiratory depression after taking the pain reliever codeine following surgery to remove tonsils (tonsillectomy) and/or adenoids (adenoidectomy).

 

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Egg yolk consumption almost as bad as smoking when it comes to atherosclerosis

 

London, Ontario, Canada (August 13, 2012) - Newly published research led by Dr. David Spence of Western University, Canada, shows that eating egg yolks accelerates atherosclerosis in a manner similar to smoking cigarettes. Surveying more than 1200 patients, Dr. Spence found regular consumption of egg yolks is about two-thirds as bad as smoking when it comes to increased build-up of carotid plaque, a risk factor for stroke and heart attack. The research is published online in the journal Atherosclerosis.

 

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Diabetes drugs taken by over 15 million Americans raises risk of bladder cancer

 

PHILADELPHIA, PA, USA (August 13, 2012) - A popular class of diabetes drugs increases patients' risk of bladder cancer, according to a new study published online this month in the Journal of the National Cancer Institute. Researchers from the Perelman School of Medicine at the University of Pennsylvania found that patients taking thiazolidinedione (TZDs) drugs – which account for up to 20 percent of the drugs prescribed to diabetics in the United States -- are two to three times more likely to develop bladder cancer than those who took a sulfonylurea drug, another common class of medications for diabetes.

 

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Special assessments needed to support people with incontinence who have neurological conditions, says NICE

 

London, UK (August 8, 2012) - Detailed assessments should be offered to people who have neurological conditions like stroke, multiple sclerosis and head and spinal cord injuries, and who experience incontinence or other urinary problems. A new NICE guideline out today (8 August) hopes to minimise the distressing effects that lower urinary tract dysfunction can have on people with neurological conditions and their families, and promote active participation in their care.

 

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NICE publishes guideline on assessing risk of fragility fracture in adults

 

London, UK (August 8, 2012) - The National Institute for Health and Clinical Excellence (NICE) today (8 August) publishes final guidance on assessing the risk of fragility fracture in adults. The short clinical guideline advises on methods to help clinicians assess who might be at risk of a fragility fracture, and will support them in identifying who will benefit from treatments that help prevent such fractures occurring.

 

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Sleep affects potency of vaccines

 

San Francisco, CA, USA (August 1, 2012) - As moms have always known, a good night's sleep is crucial to good health -- and now a new study led by a UCSF researcher shows that poor sleep can reduce the effectiveness of vaccines. The study is the first performed outside a sleep laboratory to show that sleep duration is directly tied to vaccine immune response, the authors said.

 

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Nurse staffing, burnout linked to hospital infections

 

Washington, DC, USA (July 30, 2012) - Nurse burnout leads to higher healthcare-associated infection rates (HAIs) and costs hospitals millions of additional dollars annually, according to a study published in the August issue of the American Journal of Infection Control, the official publication of the Association for Professionals in Infection Control and Epidemiology (APIC).

 

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Women have a poorer quality of life after a stroke or mini stroke than men

 

Stockholm, Sweden (July 25, 2012) - Having a stroke or mini stroke has a much more profound effect on women than men when it comes to their quality of life, according to research published in the August issue of the Journal of Clinical Nursing. Swedish researchers at Danderyd Hospital, Stockholm, asked all patients attending an out-patient clinic over a 16-month period to complete the Nottingham Health Profile, a generic quality of life survey used to measure subjective physical, emotional and social aspects of health.

 

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Helping Alzheimer's patients stay independent

 

Study shows caregivers may be unintentionally making people with Alzheimer’s more dependent by underestimating their abilities

 

Edmonton, AB, Canada (July 18, 2012) - Family members or professional caregivers who do everything for older adults with Alzheimer's disease may just be wanting to help, but one University of Alberta researcher says that creating excess dependency may rob the patients of their independence and self-worth. U of A psychologist Tiana Rust, who recently completed her doctoral program, says her research indicated that caregivers adopted a "dependency support script," assuming control of tasks they believed patients seemed no longer capable of doing for themselves. She says this model shows that the caregivers' beliefs, rather than the person's real abilities, drove their interactions with the patients. Her research also showed that the caregivers' actions were also seemingly incongruous with their values of wanting to treat patients with respect and promote their independence.

 

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Lungs respond to hospital ventilator as if it were an infection

 

Columbus, Ohio, USA (July 18, 2012) - When hospital patients need assistance breathing and are placed on a mechanical ventilator for days at a time, their lungs react to the pressure generated by the ventilator with an out-of-control immune response that can lead to excessive inflammation, new research suggests. While learning that lungs perceive the ventilation as an infection, researchers also discovered potential drug targets that might reduce the resulting inflammation - a tiny piece of RNA and two proteins that have roles in the immune response.

 

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FDA approves weight-management drug Qsymia

 

Silver Spring, MD (July 17, 2012) - The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).

 

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Experimental drug may extend therapeutic window for stroke

 

Clinical safety trials in humans to start this summer

 

Los Angeles, Cal. USA (July 17, 2012) — A team led by a physician-scientist at the University of Southern California (USC) has created an experimental drug that reduces brain damage and improves motor skills among stroke-afflicted rodents when given with federally approved clot-busting therapy. Clinical trials to test the safety of the drug in people are expected to start later this summer.

 

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Nurses need to counteract negative stereotypes of the profession in top YouTube hits

 

(July 16, 2012) - The nursing profession needs to harness the power of the video-sharing website YouTube to promote a positive image of nurses, after research found that many of the top hits portray them in a derogatory way. That is the key finding of research published in the August issue of the Journal of Advanced Nursing.

Researchers examined the YouTube database to find the most viewed videos for "nurses" and "nursing". Ninety-six videos were included after preliminary analysis of the first 50 hits for each word. The top ten hits - attracting between 61,695 and 901,439 hits - were then analysed in greater detail.

 

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Treating stress prevented new MS brain lesions

 

New Orleans, LA (July 16, 2012) – Research conducted by Jesus Lovera, MD, Assistant Professor of Neurology at LSU Health Sciences Center New Orleans, and colleagues has shown that stress management treatment significantly reduced the formation of new brain lesions in people with multiple sclerosis (MS) over the course of treatment. These lesions are markers of disease activity used to objectively measure disease status. The work is published ahead of print and is now available online in Neurology.

 

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Global study finds people with haemophilia fight challenges in their professional career but succeed in completing education and getting a job

 

Paris, France (July 9, 2012) – The first results from a new global study mapping the psychosocial aspects of living with haemophilia show eight out of 10 people with haemophilia have experienced a negative impact of haemophilia on their professional career, with one in five believing they have lost a job because of haemophilia.i However, the findings from the study also show that 85% of people with haemophilia describe themselves as educated and only 8% are not able to find employment.(1)

 

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Wound care meta-review draws firm conclusions from Cochrane published studies

 

London, UK (July 9, 2012) - Robust evidence exists for some wound care interventions, but there are still gaps in current knowledge requiring international consensus and further high-level clinical evidence, according to a paper published online by BJS, the British Journal of Surgery.

 

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Sanofi-aventis withdraws its marketing authorisation application for Mulsevo (semuloparin sodium)

 

London, UK (July 9, 2012) - The European Medicines Agency has been formally notified by Sanofi-aventis of its decision to withdraw its application for a centralised marketing authorisation for the medicine Mulsevo (semuloparin sodium), 20 mg, solution for injection. Mulsevo was intended to be used for the primary prophylaxis of venous thromboembolism (VTE) in cancer patients receiving chemotherapy for locally-advanced or metastatic solid tumours.

 

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HPV vaccine reduces infection, even in unvaccinated

Study shows evidence of herd protection

 

Cincinnati, Ohio, USA (July 9, 2012) - The HPV vaccine not only has resulted in a decrease in human papillomavirus infection in immunized teens but also in teens who were not immunized.

The study is believed to be the first to show a substantial decrease in HPV infection in a community setting as well as herd protection – a decrease in infection rates among unimmunized individuals that occurs when a critical mass of people in a community is immunized against a contagious disease.

 

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FDA introduces new safety measures for extended-release and long-acting opioid medications

Strategy emphasizes education for prescribers, patients on highly potent pain relievers

 

Silver Spring, MD, USA (July 9, 2012) -The U.S. Food and Drug Administration (FDA) today approved a risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioids, highly potent drugs approved for moderate to severe, persistent pain that requires treatment for an extended period.

 

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European Medicines Agency updates guideline on drug interactions

 

London, UK (July 6, 2012) - The European Medicines Agency has finalised the update to its guideline on the investigation of drug interactions (http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500129606).  The update, published today, is a major revision of the previous document adopted in 1997. It includes information on how pharmaceutical companies should study potential interactions between new medicines and medicines that are already on the market, as well as covering the effects of food intake.

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European Medicines Agency finalises update to Parkinson's disease guideline

 

London, UK (July 6, 2012) - The European Medicines Agency has published an update to its guidance for pharmaceutical companies developing medicines for Parkinson's disease.

The update to the guideline on clinical investigation of medicinal products in the treatment of Parkinson's disease (http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500129601), published today, covers how companies should design and carry out studies of medicines that aim to improve the disease's symptoms in patients and to modify the progress of the disease itself.

 

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Methadone linked to 30 percent of prescription painkiller overdose deaths

 

Atlanta, GA, USA (July 3, 2012) - The prescription drug methadone accounted for 2 percent of painkiller prescriptions in the United States in 2009, but was involved in more than 30 percent of prescription painkiller overdose deaths, according to a CDC Vital Signs report released today by the Centers for Disease Control and Prevention.

 

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FDA approves first over-the-counter home use HIV test kit

 

Silver Spring, MD, USA (July 3, 2012) - The U.S. Food and Drug Administration today approved the OraQuick In-Home HIV Test, the first over-the-counter, self-administered HIV test kit to detect the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

 

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Janssen-Cilag International NV withdraws its application for an extension of the indication for Velcade (bortezomib)

 

London (July 3, 2012) - The European Medicines Agency has been formally notified by Janssen-Cilag International NV of its decision to withdraw its application for an extension of the therapeutic indication for the centrally authorised medicine Velcade (bortezomib).

 

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FDA allows marketing of first test to identify certain bacteria associated with bloodstream infections

 

Test makes it possible to identify potentially serious illness causing bacteria hours after a positive blood culture

 

Silver Spring, MD, USA (June 27, 2012) - The U.S. Food and Drug Administration today allowed marketing of the first nucleic acid test that can identify 12 different bacterial types known to cause bloodstream infections. The test allows for simultaneous identification of the bacteria and three associated resistance genes in just a few hours after the first sign of bacterial growth. Traditional methods may require two to four days to produce bacterial identification and resistance results.

 

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FDA approves Belviq to treat some overweight or obese adults

 

Silver Spring, MD, USA (June 27, 2012) - The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.

 

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FDA approves Myrbetriq for overactive bladder

 

Silver Spring, MD, USA (June 27, 2012) - The U.S. Food and Drug Administration today approved Myrbetriq (mirabegron) to treat adults with overactive bladder, a condition in which the bladder muscle cannot be controlled, squeezes too often or squeezes without warning.

 

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European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices

 

London, UK (June 25, 2012) - The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) today.

The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines. These are:

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European Medicines Agency advises doctors treating patients with nosocomial pneumonia with Doribax

 

Current dosing recommendations may not be enough for serious cases; no change in advice for all other approved indications

 

London, UK (June 22, 2012) - The European Medicines Agency has given new advice for the treatment of patients with nosocomial pneumonia, also known as hospital-acquired pneumonia, with Doribax (doripenem). A review of available data raises concerns that the currently approved dose of Doribax of 500mg every 8 hours may not be sufficient to treat all patients with nosocomial pneumonia, including ventilator-associated pneumonia.

 

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EMA recommends restricting use of tolperisone medicines

 

Benefit-risk profile for oral tolperisone considered positive only for adults with post-stroke spasticity and negative for injectable tolperisone

 

London, UK (June 22, 2012) - The European Medicines Agency has recommended restricting the use of tolperisone, a muscle relaxant authorised to treat a variety of different conditions, including spasticity due to neurological disorders and muscle spasms associated with diseases of the spine and large joints in several European Union countries since the 1960s.

 

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European Medicines Agency recommends restricting use of trimetazidine-containing medicines

 

Restricted indication for patients with stable angina pectoris and deletion of existing indications for treatment of vertigo, tinnitus and vision disturbance

 

London, UK (June 22, 2012) - The European Medicines Agency has recommended restricting the use of trimetazidine-containing medicines in the treatment of patients with angina pectoris to second-line, add-on therapy. For all other indications the Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of these medicines were not sufficiently demonstrated and did not outweigh the risks. The CHMP therefore recommended their deletion from the marketing authorisation.

 

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