approval

AIM: To adapt the Nursing Authority and Autonomy Scale (NAAS) into Turkish the Nursing Authority and Autonomy Scale (NAAS) to Turkish and assess its psychometric properties for Turkish nurses and nurse managers. BACKGROUND: The NAAS is a tool that specifically measures nursing authority and autonomy from the perspectives of nurses and nurse managers. METHODS: The study sample consisted of 160 nurse managers and 266 staff nurses. Content validity was assessed using expert approval...

Growing awareness of the multiplicity of roles for the IL-1 family in immune regulation has prompted research exploring these cytokines in the context of vaccine-induced immunity. While tightly regulated, cytokines of the IL-1 family are normally released in response to cellular stress and in combination with other danger/damage associated molecular patterns (DAMPs), triggering potent local and systemic immune responses. In the context of infection or autoimmunity, engagement of IL-1 family receptors links robust innate responses to adaptive immunity...

Triple-negative breast cancer (TNBC) accounts for 15% of all breast cancers and is associated with poor long-term outcomes compared to other breast cancer subtypes. Currently, chemotherapy remains the main modality of treatment for early-stage TNBC, as there is no approved targeted therapy for this subtype. The biologic heterogeneity of TNBC has hindered the development and evaluation of novel agents, but recent advancements in subclassifying TNBC have paved the way for further investigation of more effective systemic therapies, including cytotoxic and targeted agents...

BACKGROUND: Panobinostat was recently approved by the US Food and Drug Administration and European Commission in combination with bortezomib and dexamethasone for patients with multiple myeloma who have received ≥ 2 regimens, including bortezomib and an immunomodulatory drug. The PANEX (panobinostat expansion) treatment protocol provided access to panobinostat and gathered additional safety data before commercial availability. PATIENTS AND METHODS: In treatment phase 1, patients received panobinostat 20 mg 3 times per week plus bortezomib 1...

Non-Hodgkin lymphoma (NHL) is the most common hematologic malignancy. More than 20,000 people in United States, more than 37,000 people in Europe and more than 199,000 people worldwide die of NHL every year. Recent advances in immunotherapeutic approaches for cancer have resulted in development of new classes of very effective immunotherapeutic approaches including chimeric antigen receptor T (CAR-T) cell therapy that are designed to bypass cancer immune evasion. Here, we review recent advances in CAR-T cell therapy for NHL...

Lysosomal acid lipase deficiency (LAL-D) results in progressive microvesicular hepatosteatosis, fibrosis, cirrhosis, dyslipidemia, and vascular disease. Interventions available prior to enzyme replacement therapy development, including lipid lowering medications, splenectomy, hematopoietic stem cell and liver transplantation were unsuccessful at preventing multi-systemic disease progression, and were associated with significant morbidity and mortality. We report two sisters, diagnosed in infancy, who succumbed to LAL-D with accelerated disease progression following splenectomy and liver transplantation...

Of the 34 FDA approved oral small-molecule kinase inhibitors (KI), 23 (68%) have warnings for hepatotoxicity in product labeling. To better understand the mechanisms of KI hepatotoxicity and whether such effects can be predicted, we examined 34 KIs for cytotoxicity in primary rat and human hepatocytes. The hepatocytes were treated with KIs at ten concentrations normalized to maximal therapeutic blood levels (Cmax). At 5 and 24 h post treatment, lactate dehydrogenase or alanine aminotransferase leakage, caspase 3/7 activities and cellular adenosine triphosphate levels were measured...

Non-alcoholic fatty liver disease is the most prevalent hepatopathy, estimated at 30% in the general population. In the coming years, it will likely be the most common indication for liver transplantation and the most frequent cause of hepatocellular carcinoma. Current treatment for non-alcoholic fatty liver disease is based on dietary and exercise interventions that have been shown to be efficacious, even for reverting fibrosis. Unfortunately, compliance with general measures involving lifestyle modifications is very poor, making pharmacologic strategies a necessary option...

Extralabel drug use is the use of a Food and Drug Administration (FDA)-approved drug in a manner different from what is stipulated on the approved label. Compounding is the process of preparing a medication in a manner not indicated on the label to create a formulation specifically tailored to the needs of an individual patient. Extralabel drug use and compounding are vital aspects of safe and effective drug delivery to patients in exotic animal practice. There are few FDA-approved drugs for exotic animal species, and many approved drugs for other species are not available in suitable formulations for use in exotic animals...

With specialized care, patients with myasthenia gravis can have very good outcomes. The mainstays of treatment are acetylcholinesterase inhibitors, and immunosuppressive and immunomodulatory therapies. There is good evidence thymectomy is beneficial in thymomatous and nonthymomatous disease. Nearly all of the drugs used for MG are considered "off-label." The 2 exceptions are acetylcholinesterase inhibitors and complement inhibition with eculizumab, which was recently approved by the US Food and Drug Administration for myasthenia gravis...

STUDY OBJECTIVE: To evaluate and compare the recall rates of Obstetric and Gynecologic devices approved via the Food and Drug Administration's (FDA) 510(k) and Premarket Approval (PMA) processes DESIGN: Retrospective Observational Study (Canadian Task Force Classification II-2) SETTING: Clinical settings in the United States of America that use Obstetric and Gynecologic devices SUBJECTS: 2,249 FDA approved Obstetric and Gynecologic Devices that were recalled between November 1, 2002 and December 31, 2017...

No abstract text is available yet for this article.

Atropa belladonna, commonly known as belladonna or deadly nightshade, ranks among one of the most poisonous plants in Europe and other parts of the world. The plant contains tropane alkaloids, including atropine, scopolamine, and hyoscyamine, which are used as anticholinergics in Food and Drug Administration (FDA) approved drugs and homeopathic remedies. These alkaloids can be very toxic at high dose. The FDA has recently reported that Hyland's baby teething tablets contain inconsistent amounts of Atropa belladonna that may have adverse effects on the nervous system and cause death in children, thus recalled the product in 2017...

Hepatitis A virus (HAV) infection remains a major cause of acute hepatitis worldwide and even leads to fulminant hepatitis. For screening antivirals against HAV in vitro, we develop a cell-based fluorescent reporter system named Huh-7.5.1-GA, in which HAV infection is visualized by green fluorescence protein (GFP) translocation from the cytosol into the nucleus. The reliability of Huh-7.5.1-GA for antiviral studies is validated by IFN-α, a known inhibitor of HAV replication, which impedes GFP translocation...

OBJECTIVE: To evaluate the integration of 3T non-endorectal-coil multiparametric prostate MRI (mpMRI) at two high-volume practices that routinely use mpMRI in the setting of active surveillance. MATERIALS AND METHODS: This was an IRB-approved, HIPAA-compliant, dual-institution retrospective cohort study. Subjects undergoing 3T mpMRI without endorectal coil at either study institution over a 13-month period (8/1/2015-8/31/2016) were selected based on pre-defined criteria: clinical T1/T2 Gleason 6 prostate cancer, PSA<15 ng/mL, ≥40 years-old, mpMRI within 2 years of prostate biopsy, PI-RADS v2 score assigned...

Viruses must parasitize host cell translational machinery in order to make proteins for viral progeny. In this study, we sought to use this signal transduction conduit against them by inhibiting multiple kinases that influence translation. Previous work indicated that several kinases involved in translation, including p70 S6K, p90RSK, ERK, and p38 MAPK, are phosphorylated following Rift Valley fever virus (RVFV) infection. Furthermore, inhibiting p70 S6K through treatment with the FDA approved drug rapamycin prevents RVFV pathogenesis in a mouse model of infection...

BACKGROUND: There is little published research that tests the effect of recreational marijuana legislation on risk-related cognitions and how individuals respond immediately after legislative approval. OBJECTIVES: The objective was to test whether learning about the passage of Initiative 71, a voter referendum that legalized recreational use of marijuana in the District of Columbia, would lead individuals to adopt more favorable marijuana cognitions than they had before the Initiative was passed...

Background: Off-pump coronary artery bypass surgery (OPCAB) is often complicated by hemodynamic instability, especially in patients with prior left ventricular (LV) dysfunction and appropriate choice of inotrope plays a vital role in perioperative management of these patients. Aim and Objective: To study hemodynamic effects and immediate outcome of prophylactic infusion of levosimendan in patients with the LV dysfunction undergoing OPCAB surgery and whether this strategy helps in successful conduct of OPCAB surgery...

OBJECTIVE Progress in management of high-grade gliomas (HGGs) has been hampered by poor access of potential therapeutics to the CNS. The Cleveland Multiport Catheter (CMC), which deploys 4 independent delivery microcatheters, was developed to be a reliable, high-volume delivery device for delivery of therapeutic agents to the brain and other solid organs. The authors undertook this first-in-human clinical trial effort to evaluate the delivery characteristics of the CMC in patients with HGGs. METHODS A series of pilot studies were launched after approval of a sponsor-investigator IND (investigational new drug) application to evaluate the delivery of topotecan and gadolinium-DTPA (Gd-DTPA) via the CMC in patients with recurrent HGG...

INTRODUCTION: The objective of the study is to examine how job resources modify the relationship between Dark Triad (DT) and counterproductive work behavior (CWB). Specifically the study examined (1) the direct link between DT and CWB, (2) the moderation effects of two kinds of job resources (job control and social support), and (3) the moderated moderation effect of the job resources (job control x social support) on the DT-CWB link. Moreover, the effect of social approval on CWB was controlled...