“Development and validation of parsimonious algorithms to classify acute respiratory distress syndrome phenotypes: a secondary analysis of randomised controlled trials - The Lancet” plus 4 more
“Development and validation of parsimonious algorithms to classify acute respiratory distress syndrome phenotypes: a secondary analysis of randomised controlled trials - The Lancet” plus 4 more |
- Development and validation of parsimonious algorithms to classify acute respiratory distress syndrome phenotypes: a secondary analysis of randomised controlled trials - The Lancet
- Athersys Provides Update on One-Year ARDS Study Data - GlobeNewswire
- Maternal SCH May Increase Risk for Prematurity, Neonatal Respiratory Distress - Endocrinology Advisor
- China outbreak update: 1st death reported - Outbreak News Today
- Bronchiolitis typically begins with cold symptoms - Albuquerque Journal
| Posted: 13 Jan 2020 03:39 PM PST [unable to retrieve full-text content]Development and validation of parsimonious algorithms to classify acute respiratory distress syndrome phenotypes: a secondary analysis of randomised controlled trials The Lancet |
| Athersys Provides Update on One-Year ARDS Study Data - GlobeNewswire Posted: 14 Jan 2020 03:00 AM PST  Highlights from the new and previously disclosed data include:Previously observed lower mortality for MultiStem-treated subjects compared to placebo (particularly among the prospectively defined subset of more severe ARDS patients) persisted out to one-year of follow-up;Day-365 Quality of Life (QoL) outcomes, assessed by the EQ-5D, were meaningfully better among all survivors who received MultiStem treatment compared to those who received placebo;Within the prospectively defined group of patients with more severe ARDS, MultiStem treatment was associated with a markedly greater rate of survival and progression to functional independence at one year (i.e., self-care);As measured at day-28, MultiStem treatment was associated with a higher mean ventilator-free day (VFD) score of 12.9 vs. 9.2 in the placebo group, and a higher mean intensive care unit (ICU)-free day score of 10.3 vs. 8.1 in the placebo group;As measured at day-28, among more severe ARDS patients, mean VFD in the MultiStem subgroup was 14.6 vs. 8.0 in placebo subgroup. Mean ICU-free days were 11.4 vs. 5.9 for MultiStem and placebo recipients, respectively;Lower inflammatory cytokine levels at day-7 in the MultiStem group relative to the placebo group, including IFNg, IL-6 and IL-1b among others, suggest the potential for MultiStem treatment to abate the severe inflammatory response associated with ARDS; andMultiStem treatment was well tolerated in this very sick ARDS patient population, with no serious adverse events related to administration through one year of follow-up."We believe that the more favorable outcomes, as reflected in the patient reported self-assessments, particularly among patients recovering from more severe ARDS, suggest that administration of MultiStem has the potential to meaningfully enhance the ability of these patients to reestablish functional independence and restore quality of life," noted Dr. Anthony Ting, Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs at Athersys. "Frequently, ARDS patients have a very challenging road to recovery, suffering depression or decreased physical abilities. Many are unable to return to work or engage in other activities. The prospect of being able to help many patients overcome these difficulties is very exciting, and we look forward to publishing these results."The MUST-ARDS study was designed to evaluate the impact of MultiStem treatment in subjects with acute onset of moderate to severe ARDS and was conducted at sites in the United States and United Kingdom. Treatment was required to begin within four days of ARDS diagnosis with an average treatment time of approximately two days from the diagnosis. In the Phase 2a portion of the study, 20 subjects were treated with an intravenous administration of 900 million MultiStem cells and 10 subjects received placebo; the study was not powered for the efficacy outcomes. Based on the study results, the Company is planning further development in this area and intends to submit for publication the detailed study data.About ARDSARDS is a serious immunological and inflammatory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, trauma or other events and represents a major cause of morbidity and mortality in the critical care setting. ARDS is associated with a high mortality rate and significant sequelae among survivors. The condition prolongs ICU and hospital stays and often requires extended convalescence in the hospital and rehabilitation care settings. There are limited interventions and no effective drug treatments for ARDS. There is a large unmet need for a safe treatment that can reduced mortality and improve quality of life for those suffering with ARDS. Additionally, given the high treatment costs associated with ARDS, a successful therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU.About MultiStem®MultiStem® cell therapy is a patented regenerative medicine product in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy's potential for multidimensional therapeutic impact distinguishes it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. The therapy represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon its efficacy profile, its novel mechanisms of action, and a favorable and consistent safety profile demonstrated in clinical studies, MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.About AthersysAthersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: our ability to raise capital to fund our operations; the timing and nature of results from our MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial and Healios' TREASURE and ONE-BRIDGE clinical trials in Japan; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the possibility of delays, work stoppages or interruptions in manufacturing by third parties to us, such as due to material supply constraints, contaminations, or regulatory issues, which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for the treatment of stroke, acute respiratory distress syndrome, acute myocardial infarction and trauma, and the prevention of graft-versus-host disease and other disease indications; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.Contact:William (B.J.) Lehmann President and Chief Operating Officer Tel: (216) 431-9900 bjlehmann@athersys.comKaren Hunady Director of Corporate Communications & Investor Relations Tel: (216) 431-9900 khunady@athersys.com David Schull Russo Partners, LLC Tel: (212) 845-4271 or (858) 717-2310 David.schull@russopartnersllc.com |
| Posted: 13 Jan 2020 05:30 AM PST In pregnant women, maternal thyrotropin (TSH) levels >4 mIU/L are associated with increased risks for prematurity and neonatal respiratory distress syndrome, according to study results published in The Journal of Clinical Endocrinology & Metabolism. The study included women aged ≥18 years with a singleton gestation and no known thyroid disease who were seen for prenatal care at Boston Medical Center in Massachusetts from January 2003 through May 2014 (N=8413; mean age, 29.1 years). Of all the women, 15% were white, 60% black, and 13% Hispanic. Median TSH level was 1.06 mIU/L (95% CI, 0.62-1.60 mIU/L), with 1.6% of women (n=130) having a TSH level >4 mIU/L. In their offspring, mean gestational age at birth was 38.5 weeks with a mean birth weight of 3.2 kg. Compared with maternal TSH levels ≤4 mIU/L, maternal TSH levels >4 mIU/L were associated with increased risk for prematurity (risk ratio [RR], 2.17; 95% CI, 1.15-4.07; P =.016) and neonatal respiratory distress syndrome (RR, 2.83; 95% CI, 1.02-7.86; P =.046). The researchers also found nonstatistically significant associations between TSH levels >4 mIU/L and increased RRs for fetal loss, preeclampsia/eclampsia, and low birth weight. Maternal TSH levels >4 mIU/L were not associated with preterm labor, placental abruption, cesarean section, gestational hypertension/diabetes, or neonatal intensive care unit admission. The researchers noted that their study was limited by potential selection bias and no available data on free thyroxine measurements or thyroid peroxidase antibody status for most patients. "[M]ore interventional studies are needed to ascertain the benefit of treatment of maternal [subclinical hypothyroidism] in pregnancy," the researchers wrote. Reference Lee SY, Cabral HJ, Aschengrau A, Pearce EN. Associations between maternal thyroid function in pregnancy and obstetric and perinatal outcomes [published online December 15, 2019]. J Clin Endocrinol Metab. doi:10.1210/clinem/dgz275 |
| China outbreak update: 1st death reported - Outbreak News Today Posted: 11 Jan 2020 02:33 AM PST In an update on the cluster of pneumonia cases detected in Wuhan, Hubei Province, China, we got additional information today from Chinese and Hong Kong authorities.  The Wuhan Municipal Health and Health Commission reported the following (computer translated): After the pathogen of "unknown cause of viral pneumonia" was initially determined to be a new type of coronavirus, the national, provincial and municipal expert groups immediately revised and improved plans for diagnosis, treatment, and monitoring of unexplained viral pneumonia. The Wuhan Municipal Health and Health Committee has organized tests on existing patient specimens. As of 14:00 on January 10, 2020, pathogenic nucleic acid testing has been completed. The national, provincial and municipal expert groups comprehensively judged the clinical manifestations, epidemiological history, and laboratory test results of patients admitted to the hospital for treatment, and 41 cases of pneumonia with a new coronavirus infection were initially diagnosed, of which 2 were discharged, Seven cases were severe and one died. The remaining patients were in stable condition. All 739 close contacts, including 419 medical staff, have undergone medical observation and no related cases have been found. No new cases have been detected since January 3, 2020. At present, no medical staff infections have been found, and no clear evidence of human-to-human transmission has been found. Concerning the fatality, officials report: The patient was a 61-year-old male. He was admitted to the hospital due to respiratory failure and severe pneumonia. He also had abdominal tumors and chronic liver disease. The patient purchases goods from Wuhan South China Seafood Market all year round. After admission to the hospital, symptomatic support, anti-infection, ventilator-assisted breathing, continuous ECMO in vitro life support, and other treatments did not improve his symptoms. On the evening of January 9, 2020, his heartbeat stopped and he died after rescue. Etiological results suggest that the new coronavirus is positive for nucleic acid. The deaths were diagnosed as severe pneumonia, acute respiratory distress syndrome (severe), septic shock, multiple organ failure, severe acid-base metabolism disorders, and cirrhosis. The immediate cause of death was respiratory circulation failure. According to information from the Chinese officials, investigation, epidemiological investigations revealed that the patients are mainly business operators at a market called "Hua Nan Seafood Wholesale Market" in Wuhan, which has been closed since January 1. |
| Bronchiolitis typically begins with cold symptoms - Albuquerque Journal Posted: 13 Jan 2020 11:02 PM PST Q: My niece was just admitted to the hospital for bronchiolitis. How is this different from bronchitis that adults get? A: Thanks for your question. Bronchiolitis is a common childhood viral infection, falling somewhere between a cold and pneumonia. Our respiratory tree extends from the nostrils all the way down to our alveoli, the small air sacks deep within our lungs. Air passes down 23 generations of branching airways to the alveoli, where gas exchange occurs across very thin membranes. Each generation of airway gets smaller as it goes further toward the alveoli. The large airways are called bronchi and the smaller ones are bronchioles. Bronchi commonly get inflamed and infected in adults, resulting in mucus and coughing called bronchitis, and treated with antibiotics. ................................................................ In children under the age of 2, the inflammation from a cold virus spreads quickly and often extends into the bronchioles, causing bronchiolitis. Bronchioles are easily obstructed by mucus, which leads to congestion and collapse of the alveoli just beyond. During this process, the child can show increasing work of breathing, trying to compensate for the blocked airways and collapsed lung segments. Most viral infections causing bronchiolitis last between one and two weeks. The worst symptoms may occur near the end of the first week. Common viruses include respiratory syncytial virus (RSV), influenza virus and rhinovirus, among others. Bronchiolitis typically begins with cold symptoms – runny nose, congestion, cough – and may progress to increasing respiratory distress with rapid breathing, wheezing, and visible pulling in of the chest and abdomen. Bronchiolitis is responsible for approximately 100,000 pediatric hospital admissions annually in the United States. Initially, the child will appear to have a cold, which will gradually worsen to include fever, cough and congestion. Smaller babies may become dehydrated due to decreased oral intake. Babies under the age of 1 are obligate nose breathers, which means that a stuffy nose makes it very hard to breathe and drinking or breast feeding with a stuffy nose can be difficult. Suctioning out their nose with a bulb suction can improve things immensely. Some babies will get sicker and end up at the pediatrician's office where the doctor will assess the baby's work of breathing and check their oxygen saturation. If the work of breathing increases, or the oxygen saturation is decreased, the baby may be admitted to the hospital. A typical stay is four to 10 days. During that time, the child will receive what we call supportive care, which consists of suctioning, rehydration with fluids and oxygen via nasal cannula. Supportive care does not include antibiotics. This is because bronchiolitis is a disease caused by viruses and antibiotics have no effect on viruses. Antibiotics only treat infections caused by bacteria. ................................................................ If the child is sick enough to be admitted to the pediatric intensive care unit, they may also receive a chest X-ray, a trial of an albuterol nebulizer and be asked not to eat or drink anything until their breathing eases. In some cases, the baby's work of breathing may become overwhelming, causing total body stress and fatigue. Despite maximum effort, the baby may not be able to maintain adequate oxygen saturation. For these children, the next level of care is intubation and mechanical ventilation. The ventilator helps the child breathe, giving bigger and more breaths, and more oxygen, than the child could manage on their own. Children, even babies, usually recover from this illness well, with no long-term effects. Studies have shown that infants hospitalized with RSV or rhinovirus bronchiolitis have an increased risk of recurrent wheezing during the first 10 years of life, but not necessarily of long-term asthma. It is possible to have back-to-back episodes of bronchiolitis and even to have multiple admissions to the hospital during the same season. Good handwashing and excellent nasal suctioning are important. The viruses that cause bronchiolitis are contagious, spreading through touch and coughing/sneezing. It is thought that 3 feet is a safe distance. Washing your hands before picking up or your baby is a good idea. Hand sanitizer is also effective, if used properly. Some babies qualify for a preventive medication called palivizumab. This is an antibody that helps minimize the severity of RSV bronchiolitis, should the baby contract it. It is used for very premature babies or babies with cyanotic congenital heart disease. Bronchiolitis season is from November through April annually, and we are seeing many children in our clinics and in our hospital. Do not hesitate to contact your pediatrician if you feel your child's cold is becoming more severe and requires more attention. Anjali Subbaswamy is a Pediatric Intensive Care Physician at UNM. Please send your questions to her at ASubbaswamy@salud.unm.edu. |
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