TY - JOUR. T1 - Berlin heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. AU - Almond, Christopher S.. AU - Morales, David L.. AU - Blackstone, Eugene H.. AU - Turrentine, Mark W.. AU - Imamura, Michiaki. AU - Massicotte, M. Patricia. AU - Jordan, Lori C.. AU - Devaney, Eric J.. AU - Ravishankar, Chitra. AU - Kanter, Kirk R.. AU - Holman, William. AU - Kroslowitz, Robert. AU - Tjossem, Christine. AU - Thuita, Lucy. AU - Cohen, Gordon A.. AU - Buchholz, Holger. AU - St. Louis, James D.. AU - Nguyen, Khanh. AU - Niebler, Robert A.. AU - Walters, Henry L.. AU - Reemtsen, Brian. AU - Wearden, Peter D.. AU - Reinhartz, Olaf. AU - Guleserian, Kristine J.. AU - Mitchell, Max B.. AU - Bleiweis, Mark S.. AU - Canter, Charles E.. AU - Humpl, Tilman. N1 - Copyright: Copyright 2013 Elsevier B.V., All rights reserved.. PY - 2013/4/23. Y1 - 2013/4/23. N2 - BACKGROUND - : Recent data suggest that the Berlin Heart EXCOR Pediatric ventricular assist device is ...

Amifampridine (pyridine-3,4-diamine, 3,4-diaminopyridine, 3,4-DAP) is used as a drug, predominantly in the treatment of a number of rare muscle diseases. The free base form of the drug has been used to treat congenital myasthenic syndromes and Lambert-Eaton myasthenic syndrome (LEMS) through compassionate use programs since the 1990s and was recommended as a first line treatment for LEMS in 2006, using ad hoc forms of the drug, since there was no marketed form. Around 2000 doctors at Assistance Publique - Hôpitaux de Paris created a phosphate salt form, which was developed through a series of companies ending with BioMarin Pharmaceutical which obtained European approval in 2009 under the trade name Firdapse, and which licensed the US rights to Catalyst Pharmaceuticals in 2012. As of January 2017, Catalyst and another US company, Jacobus Pharmaceuticals, which had been manufacturing the free base form and giving it away for free since the 1990s, were racing to obtain FDA approval for their ...

CULVER CITY, Calif., June 27, 2014 (GLOBE NEWSWIRE) -- The Coalition for Pulmonary Fibrosis (CPF) is alerting the Pulmonary Fibrosis (PF) community throughout the US to a new Expanded Access Program (EAP) for an investigational therapy for Idiopathic Pulmonary Fibrosis (IPF). The launch of Boehringer Ingelheims EAP for Nintedanib makes 2014 a watershed year for IPF.

31. C. Cohen, E. DeJesus, A. Mills, G. Pierone, Jr., P. Kumar, P. Rune, R. Elion, G. Fusco, R. Levy, K. Solomon, S. Erickson-Viitanen. Potent Antiretroviral Activity of the Once-Daily CCR5 Antagonist INCB009471 Over 14 Days of Monotherapy. 4th IAS Conference on HIV Pathogenesis, Treatment and Prevention. Sydney, Australia, July 24, 2007. Abstract TUAB106.. CLINICAL RESEARCH: HIV/AIDS. Open-label compassionate use of Nitazoxanide for the treatment of Cryptosporidiosis in AIDS patients. (Unimed) 1994.. Noncomparative, multisite, open-label, 48-week study to monitor the safety and tolerability of MK-0639 (Indinavir) 800mg Q8h administered as monotherapy or in combination with reverse transcriptase inhibitor therapy for the treatment of HIV-1 infection in advanced AIDS patients (patients with CD4 counts < 50 cells/mm3) (Merck). Open-label international compassionate treatment program for the use of Saquinavir either as monotherapy or in combination with other anti-retroviral drugs in patients with ...

In previous blogs, we have discussed stem cell therapy for non-standard indications, or what we call compassionate use cases. These are cases where there is limited data to show that stem cell therapy is effective however what results we do have, may look promising. Examples include kidney disease, canine back pain, as well as several other diseases/conditions for which stem cells may be beneficial. One such indication is Immune Mediated Polyarthritis, or IMPA for short. While IMPA is a form of arthritis, it is not the typical osteoarthritis that stem cells are used for regularly. Rather than being caused by a malformed joint, wear and tear or trauma, IMPA is caused by the patients own immune system. It is important to note that polyarthritis can be caused by an infection in the patients body. Distinguishing between an infection and IMPA is imperative because treatment options are very different. In this blog, we will discuss stem cell therapy for the treatment of IMPA.. In patients with ...

The Ebola outbreak that has devastated parts of west Africa represents an unprecedented challenge for research and ethics. Estimates from the past three decades emphasise that the present effort to contain the epidemic in the three most affected countries (Guinea, Liberia, and Sierra Leone) has been insufficient, with more than 24,900 cases and about 10,300 deaths, as of March 25, 2015. Faced with such an exceptional event and the urgent response it demands, the use of randomised controlled trials (RCT) for Ebola-related research might be both unethical and infeasible and that potential interventions should be assessed in non-randomised studies on the basis of compassionate use ...

According to Beyond Pesticides recent report on state pesticide use on cannabis, California was one of six states silent on pesticide use on marijuana. Until now, the only discussion of the issue came from a 2012 report from the California Research Bureau, commissioned by CA Assembly member Linda Halderman, M.D. The report indicated that because no pesticide products were registered for use on cannabis by EPA, and given that applying a pesticide for an unregistered use is illegal under federal pesticide law, the state could confiscate any medical marijuana crop treated with a pesticide. However, it was noted that this conflicts with the states Compassionate Use Act, which guarantees ill Californians access to medical marijuana. Thus it was determined that growers could simply not spray pesticides in order to avoid potential confiscation. But because the state had not formulated any laws or regulations governing pesticide use on cannabis, the issue remained in a grey area.. The State Water ...

A bill that would allow terminally ill people to obtain experimental drugs appears headed to Governor Browns desk for the second year in a row. Brown vetoed a similar measure last year, but supporters believe conditions are right for him to sign it this time around. Brown said he vetoed last years Right-to-Try measure because he wanted time to see how changes to the FDAs Compassionate Use program streamlined the process of getting experimental drugs to terminal patients.. Nearly a year later, the new bills supporters say its time for California to step in with its own solution, because the modified federal initiative has not reduced the minimum 30-day wait for drugs.. The process may have to start over if the FDA has even one question, said the bills author, Assembly Majority Leader Ian Calderon (D-Whittier). Terminally ill patients can still end up waiting weeks and months for an approval.. Calderons measure would allow drug manufacturers to give certain terminally ill people ...

Hemp CBD Across State Lines: New Jersey , Canna Law Blog™ New Jersey seems to be saying that Hemp CBD products are allowed in the state, so long as that is legal under local, state, and federal law. That may mean that certain Hemp CBD products are not permitted under New Jersey law, considering that the FDA has repeatedly stated that Hemp CBD cannot be marketed as a drug or added to foods or dietary supplements. NJ marijuana legalization: Edibles, legal weed home grow, USA TODAY NETWORK New Jersey reporter Mike Davis answers your NJ marijuana legalization questions about edibles, legal weed home grow and the process for expungement. Legal Standing of Cannabis for New Jersey - Cannabis Industrial New Jersey Marijuana / Cannabis Medical Use Law: Legal. On January 18, 2010, the New Jersey Governor signed into law Bill S.119 allowing the Compassionate Use Medical Marijuana Act. Patients must have a valid Registry Identification Card issued by the Department of Health Medicinal Marijuana Program. ...

Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism. Principal Investigator: Nils Kucher, MD, Cardiovascular Division, Interventional Cardiology, Andreas Grüntzig Catheterization Laboratories, Raemistrasse 100 University Hospital Zurich, 8091 Zurich, Switzerland, Phone: +41 1 255 8762, [email protected]. Sponsor: Straub Medical AG, Straubstrasse, 73 23 Wangs, Schweiz. August 29, 2005. I. BACKGROUND AND SIGNIFICANCE. A) Historical Background. Acute pulmonary embolism (PE) is a potentially life-threatening disease with an overall 3-month mortality rate that exceeds 15%, with right ventricular (RV) dysfunction as the most common cause of death (1). The 30-day mortality rate in patients with massive PE, defined as cardiogenic shock or a systemic systolic pressure , 90 mm Hg, exceeds 30%. In patients with massive PE, systemic thrombolysis (2) or surgical embolectomy (3-5) in addition to anticoagulation may be life-saving, ...

Fetal research and clinical practice has been hampered by a lack of suitable investigational techniques. Currently, ultrasound is the only widely used method of studying fetal anatomy and physiology, but it has significant limitations for assessment of cardiac rhythm. The proposed study will allow us to investigate fetal magnetocardiography (fMCG) as a new tool for the study of normal and abnormal fetal heart rate and rhythm, with a goal of demonstrating probable benefit from use of the device in patients with serious fetal arrhythmia. We propose a study that will last 1-2 years and will provide data to aid in assessing the safety and effectiveness of fMCG for diagnosis and management of patients with abnormal fetal heart rate and rhythm. We hope that the data from the study will support a Humanitarian Device Exemption (HDE) application for the subject device. The safety and efficacy study designs are described below. High-risk subjects will undergo echocardiography as part of their routine ...

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.. Learn more.... ...

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.. Learn more.... ...

SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the worlds first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today record-setting results for 2012 for implants, revenue and profit.. (Photo: http://photos.prnewswire.com/prnh/20130117/LA44048) 2012 was a momentous year for the SynCardia temporary Total Artificial Heart with a record-breaking 125 implants performed at more than 50 Certified Centers worldwide, said Michael Garippa, SynCardia Chairman/CEO/President. We expect our growth trajectory to continue in 2013 as we pursue a Humanitarian Device Exemption (HDE) from the FDA for destination therapy and plan to introduce our smaller 50cc Total Artificial Heart designed to fit patients with a body surface area of less than 1.7. SynCardias accomplishments in 2012 include: -- Completion of required patient enrollment in the FDA clinical study of the Freedom@ portable driver, the worlds first wearable power supply for the SynCardia Total ...

The dolutegravir expanded access program (EAP) has been designed to provide free access to Shionogi-ViiV Healthcares investigational integrase inhibitor, ...

The Food and Drug Administrations expanded access program, which is intended to provide access to unapproved drugs for patients with a life-threatening illness and no available treatment, does not require that drug companies provide these drugs.

Almond CS, Morales DL, Blackstone EH, Turrentine MW, Imamura M, Massicotte MP, Jordan LC, Devaney EJ, Ravishankar C, Kanter KR, Holman W, Kroslowitz R, Tjossem C, Thuita L, Cohen GA, Buchholz H, St Louis JD, Nguyen K, Niebler RA, Walters HL, Reemtsen B, Wearden PD, Reinhartz O, Guleserian KJ, Mitchell MB, Bleiweis MS, Canter CE, Humpl T. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation. 2013 Apr 23; 127(16):1702-11 ...

The MRCT Center Bioethics Collaborative has published a framework and toolkit entitled Expanded Access to Investigational Products: A Practical Approach for Sponsors, Physicians, and Institutional Review Boards. This document, which is tailored to sponsors, treating physicians, and Institutional Review Boards/ Research Ethics Committees, includes a set of principles, considerations, and practical tools. It addresses expanded access to investigational products for seriously ill patients who are unable to participate in a clinical study and for whom no equivalent or satisfactory treatment options are available.. ...

Five states have enacted laws giving terminally ill patients access to experimental drugs, and 25 other states are considering similar legislation. But its unclear whether these so-called right-to-try laws will help anyone other than state legislators wishing to be seen embracing a politically popular cause.. Before it approves drugs or other treatments for human use, the federal Food and Drug Administration (FDA) requires rigorous clinical trials to ensure the drugs are safe and effective. These clinical trials can take years to complete. People with life-threatening illnesses who might benefit from an experimental treatment that is still a long way from approval have had two options. The first is to enter one of the clinical trials, which are not available to many due to geographic location and stage of illness.. The second way to gain access to an experimental drug is to apply under the FDAs expanded access program. These requests are typically granted; between 2010 and 2014, only 33 of ...

This expanded access program trial compared the efficacy of regorafenib [Bayer] in patients with patients with gastrointestinal stromal tumours after disease

in Scandinavian Journal of Gastroenterology (2002), 37(7), 818-824. Background: Two-thirds to three-fourths of patients with either refractory luminal or fistulizing Crohn disease respond to infliximab treatment. The ability or inability to respond seems to persist over ... [more ▼]. Background: Two-thirds to three-fourths of patients with either refractory luminal or fistulizing Crohn disease respond to infliximab treatment. The ability or inability to respond seems to persist over time. Biological characteristics and/or genetic background can influence the response to treatment. The aim was to assess the value of C-reactive protein and TNF-alpha serum levels before treatment as well as the TNF -308 gene polymorphism in the prediction of response to infliximab treatment in Crohn disease. Methods: Two-hundred-and-twenty-six Crohn disease patients treated in the setting of an expanded access programme to infliximab in Belgium were studied. There were 136 refractory luminal diseases and 90 ...

June 12, 2008 - The FDA designated for priority review, the New Drug Application (NDA) for GEs AdreView, a molecular imaging agent for the detection of neuroendocrine tumors in pediatric and adult patients, also encouraging the company to establish an expanded access program that is designed to grant physicians limited access to a novel agent prior to FDA approval. AdreView was submitted March 20, and accepted by the FDA May 20. A priority designation is intended for products or indications that address unmet medical needs. Under the Prescription Drug User Fee Act, the FDAs goal is to review and act on 90 percent of NDAs designated as priority review within six months of receipt.. The company began development of AdreView in 2004, and the agent was granted orphan-drug designation by FDA in December of 2006.. For more information: www.gehealthcare.com. ...

BACKGROUND. Monogenic Interferon (IFN)-mediated autoinflammatory diseases present in infancy with systemic inflammation, an IFN-response-gene-signature (IRS), inflammatory organ damage and high mortality. We used the janus kinase (JAK) inhibitor baricitinib with IFN-blocking activity in vitro, to ameliorate disease. METHODS. Between October 2011 and February 2017, 10 patients with CANDLE (chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperatures), 4 with SAVI (Stimulator of IFN genes (STING)-associated vasculopathy with onset in infancy), and 4 patients with other interferonopathies were enrolled in an Expanded Access Program. Patients underwent dose-escalation, benefit was assessed by reductions in daily disease symptoms and corticosteroid requirement. Quality-of-life, organ inflammation, changes in IFN-induced biomarkers, and safety were longitudinally assessed. RESULTS. 18 patients were treated for a mean duration of 3.0 years (1.5-4.9 years). The median daily ...

In a related real-world study presented at the same session, Graham Foster from Queen Marys University of London and colleagues looked at 467 hepatitis C patients with decompensated cirrhosis treated through the English expanded access programme.. More than 70% were men, most were white, the mean age was 56 years and 6% were HIV-positive. About half had HCV genotype 1, 41% had genotype 3 and the rest had other genotypes; 47% were treatment-experienced and 10% had received liver transplants.. These patients had MELD scores ranging from 6 to 36 (mean of about 12). Child-Pugh scores - another measure of liver disease severity - were ,7, including 66% with CP class B and 10% with class C (the most severe). More than 90% had past or present liver decompensation and many had ascites, bleeding varicose veins or encephalopathy. Others had non-hepatic manifestations deemed likely to lead to irreversible damage within a year or were judged by a review panel to have other exceptional ...

Source: Myeloma Research News. People with advanced multiple myeloma and diffuse large B-cell lymphoma (DLBCL) will soon be able to access Xpovio (selinexor) outside the U.S. through a managed access program.. This program, also known as a named patient program, allows patients and doctors in countries where a medicine is not yet approved or available access to them, provided the medicine is approved in one other country.. Karyopharm Therapeutics, the developer of Xpovio, partnered with Clinigen to open such a program. Under the agreement, Clinigen will distribute and facilitate access to Xpovio in 49 countries across Central and South America, Africa, Asia, and Europe, it announced in a press release.. The therapy will be exclusively available to patients with either multiple myeloma or DLBCL, for whom Xpovio has been approved in the U.S.. Physicians can obtain the details of Xpovios named patient program by contacting Clinigens customer service team by phone (+44-1932-824-123, or ...

The COVID-19 pandemic represents a substantial contextual change and has impacted ACCESS target groups, compounding existing challenges around gender-based violence (GBV) and disability services. Households experiencing poverty and disadvantage - comprised of persons with disabilities and/or women-headed as well as those with children - are facing greater impact from the economic downturn. With social distancing measures and restrictions to mobility, women are more vulnerable to GBV and persons with disabilities are generally more at risk of contracting or being impacted by COVID-19. In addition, and as a result of COVID-19, barriers to accessing services have increased during the pandemic.. In this context, ACCESS Program pivoted its intervention to strengthen the COVID-19 response, recovery, and resilience strategies in the disability and GBV sectors. This includes supporting Personal Protective Equipment and accessible communications materials to GBV and disability service providers, persons ...

The world s first pediatric heart pump, also known as Berlin Heart, is an effective alternative for children waiting for heart transplant.

Enterra® Therapy, also known as the gastric electrical stimulator (GES), is an implantable device used to help stimulate the smooth muscles of the stomach in patients with refractory gastroparesis who have failed all drug treatment options. It may be placed either laparoscopically or through a laparotomy depending on the need of the patient.. Enterra was approved by the FDA in 2000 for use as a humanitarian device in cases of idiopathic or diabetic Gastroparesis. This means it is only available in certain hospitals which have been reviewed and approved to perform the procedure. Because it is humanitarian in nature, it is often not approved by insurance companies or the approval process can be complicated. Medtronic reps are available to assist in getting patients approved for the procedure.. While the device is not a cure for GP, it does improve nausea and vomiting symptoms in many patients. It does NOT cause the stomach to contract and will not aid digestion. The settings on the device are ...

This is a multicenter expanded access protocol to provide human leukocyte antigen (HLA) partially-matched third-party allogeneic EBV-CTLs for the treatment of

Iryna Kuchma is the Open Access Programme Manager for EIFL. Iryna has been managing the Open Access programme since 2008. Her responsibilities include the development, delivery and evaluation of a range of open access related activities.. Under Irynas management, the Open Access Programme has many achievements, including the establishment of more than 700 open access repositories and more than 4,000 open access journals in EIFLs partner countries. The programme also supported the development of 54 open access policies in EIFL partner countries, opening up a wealth of new knowledge and research to the world. An expert on open access in developing and transition countries, Iryna is frequently asked to speak at conferences and open access events around the world. Before joining EIFL, Iryna worked as an Information Programme Manager at the International Renaissance Foundation (part of Soros Foundation network in Ukraine) and also coordinated the Arts and Culture Programme there.. Iryna is a member ...

The Canadian Index of Wellbeing (CIW) released its national report. The main message is that there is a massive gap between how well the economy is doing and Canadians wellbeing - and the gap is growing. The report calls for a stronger focus on upstream health promotion and expanded access to the Community Health Centre model. You can read the full report and key messages for more information.. ...

Lancet Infectious Diseases Dec 2017 Volume 17 Number 12 p1219-1318 e383-e433 http://www.thelancet.com/journals/laninf/issue/current Articles Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report Pierre-Stéphane Gsell, Anton Camacho, Adam J Kucharski, Conall H Watson, Aminata Bagayoko, Séverine Danmadji Nadlaou, Natalie E…

Neurocutaneous melanosis (NCM) is a rare congenital disorder characterized by the association of large and/or multiple congenital melanocytic nevi (CMN) of the skin with melanocytic lesions of the leptomeninges, including melanocytosis. Leptomeningeal melanocytosis carries a poor prognosis once neurological symptoms develop. Despite surgery, which is often not radical, few other treatment options exist. Recently, it was demonstrated that early embryonic, post-zygotic somatic mutations in the NRAS gene are implicated in the pathogenesis of NCM. In this report, we present a 13-year-old boy with NCM and progressive symptomatic leptomeningeal melanocytosis. A somatic NRASQ61K mutation was present in both CMN as well as the melanocytosis. Despite repeated surgery, the patient showed clinical progression. Therefore, treatment with MEK162, a MEK inhibitor, was started on compassionate use base. The patient died only five days later, i.e. too early to expect a clinical effect of MEK162 therapy. We therefore

But first, you need to understand what I mean about right-to-try. Basically, right-to-try laws rest on the false premise that the FDA is so slow and so bureaucratic that cures are being kept from terminally ill patients, or at least drugs that might hugely extend their life expectancies. The situation is presented as so dire that right-to-try is necessary, which basically allows terminally ill patients to bypass the FDA and receive experimental therapeutics from companies developing them without having to go through the FDAs Expanded Access program (which basically does the same thing, providing access to experimental therapeutics before they are FDA-approved). Its an idea promoted by a Libertarian think tank, the Goldwater Institute, and the branding has been very successful, to the point where, politically, opposing right-to-try is viewed as the equivalent of taking the terminally ills last chance away from them, wanting them to die horribly, all while pissing on an apple pie and burning ...

New research published in Epilepsia, a journal of the International League Against Epilepsy (ILAE), suggests that an investigational neurological treatment derived from cannabis may alter the blood levels of commonly used antiepileptic drugs. It is important for clinicians to consider such drug interactions during treatment of complex conditions.. Cannabidiol (CBD), a compound developed from the cannabis plant, is being studied as a potential anticonvulsant, and it has demonstrated effectiveness in animal models of epilepsy and in humans. An ongoing open label study (Expanded Access Program) conducted by investigators at the University of Alabama at Birmingham is testing the potential of CBD as a therapy for children and adults with difficult to control epilepsy. The study includes 39 adults and 42 children, all of whom receive CBD.. Because all of the participants are also taking other seizure drugs while they are receiving the investigational therapy, investigators checked the blood levels of ...

Because we choose our grantees strategically and provide funding to organizations and programs that have future scalability, replication, and sustainability, Harambe Entrepreneur Alliance was the perfect choice to begin a fruitful partnership.. Harambe is a network of African innovators running social enterprises that are creating positive and scalable change in their communities. They are highly educated individuals with a passion to return to their native African country to start businesses that address pressing social or economic needs. The alliance provides social entrepreneurs with essential resources such as access to training, markets, capital, and support networks. One of our main goals when partnering with Harambe was to support social enterprises that had already raised funds or had some revenue, but have trouble finding more partners and funders to help their businesses scale successfully. So, we decided to use our philanthropic funds to create the Global Access Program (GAP), a ...

Thrombocytopenia is used as an early marker of sepsis in neonate. Fungal sepsis is associated with greater degree of thrombocytopenia than is seen with either gram positive or gram negative organisms.

Cabazitaxel-C13 is a C13 labeled cabazitaxel. Cabazitaxel is a semi-synthetic derivative of the natural taxoid 10-deacetylbaccatin III with potential antineoplastic activity. Cabazitaxel binds to and stabilizes tubulin, resulting in the inhibition of microtubule depolymerization and cell division, cell cycle arrest in the G2/M phase, and the inhibition of tumor cell proliferation. Unlike other taxane compounds, this agent is a poor substrate for the membrane-associated, multidrug resistance (MDR), P-glycoprotein (P-gp) efflux pump and may be useful for treating multidrug-resistant tumors. In addition, cabazitaxel penetrates the blood-brain barrier (BBB). Check for active clinical trials or closed clinical trials using this agent. (

NYSE: LLY) today announced that the company has been working to facilitate the withdrawal of Lartruvo® (olaratumab) from the market for the treatment of advanced soft tissue sarcoma (STS). Lillys actions to withdraw Lartruvo from the market follow the failure of the Phase 3 ANNOUNCE clinical trial, in which Lartruvo did not improve survival for patients. Lilly is establishing a program to ensure current patients will have access to Lartruvo with limited interruption after it is withdrawn from the market. The program will be established as allowed by local country regulations.. Lilly is working to ensure that patients who are currently receiving Lartruvo may, in consultation with their physician, continue their course of therapy if they have been informed of the risks of Lartruvo and the results of the ANNOUNCE study and wish to continue, subject to local laws and regulations. No new patients should receive Lartruvo outside of participation in ongoing clinical trials. Lilly also is working to ...

LOS ANGELES (September 23, 2014) -The Los Angeles County Board of Supervisors today approved the creation of the My Health LA (MHLA) program, which will strengthen primary care access, promote coordination and improve health outcomes for LA Countys remaining uninsured. The Community Clinic Association of Los Angeles County (CCALAC) lauded the action, commending the Board and the County.. LAs health centers are deeply committed to this program, their ongoing partnership with LA County, and most importantly, the patients they serve, said CCALAC President and CEO Louise McCarthy. Our joint efforts to build and implement My Health LA will create a strong foundation for the continued development of a world-class system of care for all residents of LA County.. Clinic leaders voiced their support for the program and the ongoing partnership. We are committed to the success of My Health LA, said Dr. Elisa Nicholas, CCALAC Board Chair and President of The Childrens Clinic Serving Children and ...

The gist: Patients with recurrent chest wall (RCW) breast cancer in the European Union and Switzerland will now have access to a new treatment called ThermoDox. ThermoDox is a new way of delivering the chemotherapy drug doxorubicin. ThermoDox is spread throughout the body by the bloodstream, but it is not activated unless a doctor heats a body part to 39.5 - 42 degrees Celsius. That way, the patient can have the drug activated only to the part of the body where it is needed. Based on promising results in patients in clinical trials, ThermoDox will now be available in Europe in an Early Access Program.. Celsion Corporation (NASDAQ:CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, today announced that it has signed a license and distribution agreement with myTomorrows to implement an Early Access Program for ThermoDox®, its proprietary heat-activated liposomal encapsulation of doxorubicin, in all countries of the European Union ...

The mission of The Commonwealth Fund is to promote a high-performing health care system that achieves better access, improved quality, and greater efficiency, particularly for societys most vulnerable, including low-income people, the uninsured, minority Americans, young children, and elderly adults. ...

program is no longer operating from LAMP Community Health Centre. For public access to computers please visit your local Toronto Public Library branch ...

On a recent Wednesday morning, Michelle Nepton, enrollment specialist at Vineyard Health Care Access, took a quick moment in between clients to put on a pot of coffee. It was the second full pot of the day. It was only 10:30.

Information published by JCU or otherwise made available to students when applying, may specify additional criteria to be considered in ranking applicants in order of merit if the number of applications exceeds a quota or other limit on the places made available for the course. Information provided by applicants during the application process and any other information obtained by JCU in the application process may be used by JCU to rank applicants in order of merit by reference to those additional criteria ...

In the What section it sounds as though Dr Larry Chus brainchild conference with a capital C is well established as the most popular conference on Twitter, and Symplur has the graphs and charts to prove it. My favourite one of all shows the conversation between participants physically at MedX 2013 and then expands to show all of the links and connections all over the world. I also love to see video mapping of the way that conversations on Twitter spread through groups and individuals. If you look at this page you can see a time lapse video map of the conversation in 2012, and last year the number of tweets was up 170% from then. ...

These data demonstrate that the IL-17 pathway does not have a major contribution to the inflammatory pathology leading to organ failure in fungal sepsis, and support the concept that the IL-17 pathway is protective during fungal sepsis. In addition, IL-17 deficiency does not appear to reflect a pure innate defect, since it did not result in loss of neutrophil recruitment and function during the first few hours of fungal sepsis. Furthermore, the lower TNF production in response to Candida in cells from IL-17RA-/- mice could contribute to susceptibility to disseminated candidiasis. ...

To confirm the safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in a complex colorectal procedure such as low anterior...

(McKenzi) McKenzi Carmacks face has magical powers. When she widens her saucer-blue eyes to a full twinkle, and adds the toothy grin of an aspiring two-year-old, the forces mysteriously combine to draw people near her. They cant help it. Gazing into her eyes is enough to melt your heart. But gazing into her heart -- that was what really hurt.

Descriptive info: Decision Assistance Booklet Cover and page 1.. QExA HAWAII QUEST Expanded Access for Healthy Long-Term Living.. Welcome to QUEST Expanded Access (QExA), a new Medicaid program for seniors, 65 and older, and people of all ages with disabilities.. Starting on February 1, 2009, these clients will receive their Medicaid services through a QExA health plan.. If you are eligible for QExA, you need to choose a health plan that best meets your needs.. If you dont choose a health plan SOON, the Department of Human Services (DHS) will choose one for you.. START NOW! Open this booklet and take an important step toward healthy long-term living.. Questions: Call the toll-free Helpline at 1-866-928-1959 Open 8 a.. Monday through Friday TTY line toll-free 1-866-928-1958 Visit us on the Internet at www.. qexa.. org.. Page 2.. Table of Contents:.. Step 1: Learn About Your Choices Page 3.. Step 2: Choose a Health Plan Page 4.. Step 3: Sign Up with a Health Plan Page 5.. Health Plan Information ...

2. Most quantum chemistry programs will have RHF as the default method, which implies a singlet wave function. So if you provide the program with a molecule that has an odd number of electrons (e.g. NH4) the program will complain that it cannot do a singlet calculation on a molecule with an odd number of electrons, and asks you to change either the charge or the multiplicity, i.e. to specify whether you want to do an UHF or ROHF calculation on the doublet state of the NH4 radical, or whether you meant to do a singlet RHF calculation on NH4+. You will get very different results depending on your choice, so the object here is not to use trial and error to find a combination of charge and multiplicity that satisfies the program. Rather you have to decide what makes sense chemically, before you do the calculation ...

2. Most quantum chemistry programs will have RHF as the default method, which implies a singlet wave function. So if you provide the program with a molecule that has an odd number of electrons (e.g. NH4) the program will complain that it cannot do a singlet calculation on a molecule with an odd number of electrons, and asks you to change either the charge or the multiplicity, i.e. to specify whether you want to do an UHF or ROHF calculation on the doublet state of the NH4 radical, or whether you meant to do a singlet RHF calculation on NH4+. You will get very different results depending on your choice, so the object here is not to use trial and error to find a combination of charge and multiplicity that satisfies the program. Rather you have to decide what makes sense chemically, before you do the calculation ...

This species is a member of the genus Portia, kind of spiders and smallest creatures in the list. Also known as the White-whiskered Portia, they inhabit the critical areas and secondary forests in Africa, Asia, and Australia. This spider has shown the ability to learn in laboratory tests and the bug has been labeled the smartest in the world. They perform surprisingly well in various tasks of solving problems. One of the principles of their other charming skills of spider webs to their food. To do this they will pull the rhythm in the corner of the web to mimic the trapped bug or insect intruders. If Portia had been found of this spider before, it will remember what the rhythm pattern used to achieve success. Portia labiata had large eyes and have been seen using extraordinary instinctive behavior. The spider who planned to use trial and error approach to hunting and cognitive showed a strong base. When the prey comes and goes, the spider will sit and wait for hours to have a perfect moment to ...

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Agendia is launching a patient access program to position MammaPrint in clinics, while other test makers are taking a wait-and-see approach.

NYC Care is a no - or low-cost health care access program. Click to learn more about the services offered by NYC Health + Hospitals to New Yorkers who do not qualify for or cannot afford health insurance.

With the support of USDAs Market Access Program funds, the USGC, in partnership with USDAs FAS and domestic industry associations Growth Energy and the RFA, has seen continued success in the promotion of ethanol use globally.

Iryna Kuchma, Manager of the EIFL Open Access Programme, will give a presentation on OpenAIRE at this event organized by the NI4OS-Europe (National Initiatives for Open Science in Europe) Project in Armenia. The event aims to present the Armenian OpenAIRE NOAD, its primary aims and future plans to researchers, technicians, and stakeholders. Participants will share their

The main problem that the most industrial plants suffer from is the difficulty of material planning to create the suitable environment for implementing their production plan. The perfect solution for this problem is represented by adopting the material requirement planning (MRP) system which is a computerized system, helps so much in determining the time and quantity of orders by planning and releasing the purchase and work orders. In this study it has been designed an information material requirements planning system called (IS-MRP) system, using visual basic language and Microsoft ACCESS program to build the systems database. It consists of two modules which are forecasting module and MRP module. This system has been tested in an actual industrial environment at (EIC) company, and provided with output report that included the values of: (calculated gross requirements, calculated net requirements, calculated POH inventory, calculated planned order receipts and calculated planned order ...

Credit Card Management for Monthly Design Access Program Fees. Reflex Senior Vice President, Tim Hartt, stated, The ability for our Dealers to log-in to the site is nothing new, however, the previous functionality was fairly limited. These added features are just the beginning, but a very necessary first step in building the industrys premier on-line Dealer support tool. In the future, our Dealers can expect to see vastly enhanced functionality for improving their overall business performance and industry knowledge. With an underlying sense of urgency, Reflex is always committed to improving its Dealers productivity, and these new upgrades are evidence of this commitment.. Reflex Enterprises, L.L.C. (www.xpel.com) is the leader in electronic delivery of top automotive protection products, utilizing the Web as an integral component of its design, manufacturing, distribution and customer relationship strategies. The Companys DAP software utility offers Dealers the industrys most efficient ...

Before his first birthday Elliott was diagnosed with dilated cardiomyopathy -a disease where heart muscles become stretched and thin. He was fitted with a pacemaker after his health deteriorated but it quickly became obvious that he needed more assistance. Elliott was fitted with a Berlin Heart - a mechanical device which takes over the work of the heart. He spent 400 days on this whilst he was waiting for a heart transplant - the longest time of any child in the UK. After spending over a year at GOSH, Elliott finally got his heart transplant and has made a remarkable recovery at home and has started nursery this year.. Because the London RBC Race for the Kids takes place a few days before Elliotts birthday we spoke to him about doing it and what its for. Great Ormond Street is a happy place to him, he has happy memories there. We know how much GOSH has done for us and we can never say thank you enough but every opportunity we have to show our gratitude we want to take. - Candace ...

The Berlin heart is so fascinating to see! Wed miss out on that if it were implanted! I am awestruck with the absolute miracles being performed in operating rooms and hospitals. So grateful Eddie is in a place to be getting such wonderful care. We hope they have some miracle tricks up their sleeve to keep a three year old entertained and happy as he is weaned off the sedatives. We are praying for the best heart at the best time and a quick recovery. We hope this can be a good week for all of you. We love you ...

Your doctor will provide you with detailed instructions about the administration of Mozobil (plerixafor injection) for your stem cell mobilization.

Clinical trials are fraught with potential risks and benefits, and the goal is to minimize the risks, says Richard Klein, director of the FDAs Patient Liaison Program in the Office of Health and Constituent Affairs (OHCA). When there is a hold, it means the FDA is doing its job by keeping an eye on the outcomes and adverse events and stopping a trial when theres indication of a serious problem.. When significant safety questions arise during a trial, the FDA has the option to place either a partial or full clinical hold on the trial, explains Deborah Miller, PhD, MPH, cancer patient liaison in the OHCA. In both cases, new patient enrollment is halted, but a partial hold allows enrolled patients to continue receiving the experimental treatment.. When a full hold is placed, patients already enrolled may continue therapy if the FDA approves a request for expanded access, says Miller. Such requests, which can be made by the trial sponsor or individual patients, might be granted when the ...

Tuesday, February 5, 2013. This year more than half of the nearly 13 million new cancer cases diagnosed worldwide and two-thirds of cancer deaths will occur in the worlds low and middle income countries (LMICs). Nearly a third of these deaths could have been prevented with the knowledge and technology already available today. For example, only 10% of children diagnosed with leukemia in the 25 poorest countries of the world will survive compared to 90% of children diagnosed with leukemia in Canada.. The disease burden in developing nations is growing. Caused by an inequity in health, healthcare and resulting disease, the disparities across the cancer care continuum found between rich and poor countries remain largely unaddressed. The cancer divide is the result of these disparities - explained in the report of the Global Task Force on Expanded Access to Cancer Care and Control in Developing Countries-GTF.CCC and in the book Closing the Cancer Divide: An Equity Imperative.. ...

Sunrise, Fla.-based regenerative therapies maker Bioheart Inc. is preparing to ask the FDA to allow compassionate use of its cell therapies outside of clinical trial settings. Bioheart hopes to gain expanded access for its MyoCell and LipiCell treatments in certain heart failure patients who have limited alternative options for treatment, according to a press release.. ...

Heres five interesting #SocInn links were clicking on today: Huffington Post: Education Drives Expanded Access to Opportunity in the U.S. Managing Director of Opportunity Nation, Russel Krumnow, takes a look at how dramatic gains in education have propelled overall growth in access to opportunity over the past four decades, helping to offset economic downturns such as the Great Recession. This ...

Americans say that addiction treatment works, they want to see expanded access to treatment services for those in need, and theyre willing to pay for it.

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