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https://www.readbyqxmd.com/read/28818298/enhancing-the-pediatric-drug-development-framework-to-deliver-better-pediatric-therapies-tomorrow
#1
Christina Bucci-Rechtweg
Health care professionals involved in the clinical management of children have long appreciated the limited number of therapies suitably evaluated for their optimal use in the pediatric population. In the past century, advances in regulatory policy significantly evolved adult drug evaluation. The scarcity of available patient populations, practical complexities of drug development research, and minimal financial returns have hampered pharmaceutical investment in the study of therapies for children. More recently, pediatric policy and legislation in the United States and Europe have instituted a system of obligations and incentives to stimulate investment in pediatric drug development...
August 14, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28815161/trends-and-cost-of-posterior-cervical-fusions-with-and-without-recombinant-human-bone-morphogenetic-protein-2-in-the-us-medicare-population
#2
Sue Lynn Myhre, Zorica Buser, Hans-Joerg Meisel, Darrel S Brodke, S Tim Yoon, Jeffrey C Wang, Jong-Beom Park, Jim A Youssef
STUDY DESIGN: Retrospective database review. OBJECTIVE: To analyze and report the trends and cost of posterior cervical fusions (PCFs) with and without off-label recombinant human bone morphogenetic protein-2 (rhBMP-2) in the Medicare population. METHODS: Patient records from the PearlDiver database were retrospectively reviewed from January 1, 2005, to December 31, 2012, to distinguish individuals who underwent a PCF with or without rhBMP-2...
June 2017: Global Spine Journal
https://www.readbyqxmd.com/read/28811025/simultaneous-detection-of-two-hepatocellar-carcinoma-related-micrornas-using-a-clever-single-labeled-fluorescent-probe
#3
Rong Liao, Shiyu Li, Huan Wang, Chunyan Chen, Xiaoming Chen, Changqun Cai
The simultaneous detection of two important microRNAs (miRNAs) can potentially evaluate pathological states. The simultaneous detection of miRNA-26a and miRNA-122 is proposed in this study using a cleverly designed single-labeled, dual-functional fluorescent probe with a 2-aminopurine as a fluorophore, which is a G-quadruplex single-stranded DNA. The probe can partly complement cDNA-1 and cDNA-2. cDNA-1 and cDNA-2 are complementary strands of miRNA-26a and miRNA-122, respectively. When the target miRNAs are added simultaneously, these cDNA (cDNA-1 and cDNA-2) can be competed off from the cDNA∖probe duplex to form a cDNA∖RNA heteroduplex...
August 29, 2017: Analytica Chimica Acta
https://www.readbyqxmd.com/read/28810817/struggles-over-antibiotics-physicians-stance-taking-toward-a-nonconforming-policy-in-an-intensive-care-unit
#4
Letizia Caronia, Marzia Saglietti
One of the most pressing contemporary health care challenges consists in rethinking antibiotic use to contrast the increase of multidrug resistant bacteria. Drawing on an ethnographic fieldwork in an Intensive Care Unit that adopts a nonconforming policy of antibiotic stewardship, this article analyzes doctor-doctor interaction concerning infectious disease diagnosis and antibiotic treatment. By analyzing examples of medical decision-making from a corpus of video-recorded morning briefings, we focus on physicians' stance-taking toward the ward's nonconforming policy and illustrate how it is contingently situated along a continuum from strong commitment to overt resistance...
August 1, 2017: Qualitative Health Research
https://www.readbyqxmd.com/read/28809985/a-magnetic-micropore-chip-for-rapid-1-hour-unbiased-circulating-tumor-cell-isolation-and-in-situ-rna-analysis
#5
Jina Ko, Neha Bhagwat, Stephanie S Yee, Taylor Black, Colleen Redlinger, Janae Romeo, Mark O'Hara, Arjun Raj, Erica L Carpenter, Ben Z Stanger, David Issadore
The use of microtechnology for the highly selective isolation and sensitive detection of circulating tumor cells has shown enormous promise. One challenge for this technology is that the small feature sizes - which are the key to this technology's performance - can result in low sample throughput and susceptibility to clogging. Additionally, conventional molecular analysis of CTCs often requires cells to be taken off-chip for sample preparation and purification before analysis, leading to the loss of rare cells...
August 15, 2017: Lab on a Chip
https://www.readbyqxmd.com/read/28809936/benefits-and-safety-of-gabapentinoids-in-chronic-low-back-pain-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#6
Harsha Shanthanna, Ian Gilron, Manikandan Rajarathinam, Rizq AlAmri, Sriganesh Kamath, Lehana Thabane, Philip J Devereaux, Mohit Bhandari
BACKGROUND AND OBJECTIVE: Chronic Low Back Pain (CLBP) is very common, with a lifetime prevalence between 51% and 80%. In majority, it is nonspecific in nature and multifactorial in etiology. Pregabalin (PG) and Gabapentin (GB) are gabapentinoids that have demonstrated benefit in neuropathic pain conditions. Despite no clear rationale, they are increasingly used for nonspecific CLBP. They necessitate prolonged use and are associated with adverse effects and increased cost. Recent guidelines from the National Health Service (NHS), England, expressed concerns on their off-label use, in addition to the risk of misuse...
August 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28809729/fibrates-for-primary-biliary-cholangitis-what-s-all-the-hype
#7
Cynthia Levy
Ursodeoxycholic acid is the first-line therapy for primary biliary cholangitis. However, a subset of patients fail to show biochemical response. For these patients, adjuvant therapies are warranted. Obeticholic acid was conditionally approved as a second-line drug. Evidence is building up in favor of fibrates, which are available for off-label use.
August 8, 2017: Annals of Hepatology
https://www.readbyqxmd.com/read/28808623/use-of-recombinant-human-bone-morphogenetic-protein-2-in-spine-surgery
#8
REVIEW
Marios Lykissas, Ioannis Gkiatas
Bone morphogenetic proteins are osteoinductive factors which have gained popularity in orthopaedic surgery and especially in spine surgery. The use of recombinant human bone morphogenetic protein-2 has been officially approved by the United States Food and Drug Administration only for single level anterior lumbar interbody fusion, nevertheless it is widely used by many surgeons with off-label indications. Despite advantages in bone formation, its use still remains a controversial issue and several complications have been described by authors who oppose their wide use...
July 18, 2017: World Journal of Orthopedics
https://www.readbyqxmd.com/read/28808224/off-label-use-of-crizotinib-as-a-neoadjuvant-treatment-for-a-young-patient-when-conventional-chemotherapy-gave-no-benefits-in-stage-iiia-non-small-cell-lung-cancer
#9
Delphine Dumont, Pascal Dô, Delphine Lerouge, Gaëtane Planchard, Marc Riffet, Catherine Dubos-Arvis, Serge Danhier, Radj Gervais
BACKGROUND The treatment of locally advanced non-small cell lung cancer involves a combination of chemotherapy, surgery, and radiotherapy. Each case is discussed and the best strategy is chosen individually, following international guidelines. CASE REPORT A 37-year-old man was diagnosed with locally advanced broncho-pulmonary adenocarcinoma (stage IIIA). The disease was stable after 2 cycles of cisplatin plus Navelbine used as neoadjuvant therapy. FISH analysis revealed an ALK rearrangement. The patient then received unlicensed crizotinib as second-line neoadjuvant treatment, which led to an almost complete radiological and metabolic response...
August 15, 2017: American Journal of Case Reports
https://www.readbyqxmd.com/read/28808084/glycopyrronium-for-severe-drooling-in-children
#10
(no author information available yet)
Drooling of saliva is common in children with physical, intellectual and learning disability, and with poor neuromuscular coordination and oral control.(1) It can cause skin breakdown, damage to clothes and equipment and psychosocial problems for the child and family. For many years, glycopyrronium has been prescribed off-label using the injection solution given orally or tablets crushed and suspended in water, or as unlicensed products that were imported or manufactured as pharmaceutical specials.(2,3) In January 2017, a glycopyrronium oral solution (Sialanar-Proveca Limited) became available in the UK as the first licensed product for the treatment of severe drooling (sialorrhoea) in children and adolescents aged 3 years and older with chronic neurological disorders...
August 2017: Drug and Therapeutics Bulletin
https://www.readbyqxmd.com/read/28807936/genomic-alterations-in-circulating-tumor-dna-from-diverse-cancer-patients-identified-by-next-generation-sequencing
#11
Maria Schwaederle, Ranajoy Chattopadhyay, Shumei Kato, Paul T Fanta, Kimberly C Banks, In Sil Choi, David E Piccioni, Sadakatsu Ikeda, AmirAli Talasaz, Richard B Lanman, Lyudmila Bazhenova, Razelle Kurzrock
Non-invasive genomic profiling of tumors may be possible with next-generation sequencing (NGS) of blood-derived circulating tumor DNA (ctDNA), but proof of concept in a large cohort <p>of patients with diverse cancers has yet to be reported. Here we report the results of an analysis of plasma-derived ctDNA from 670 patients with diverse cancers.</p> The tumors represented in the patient cohort were mainly gastrointestinal (31.8%), brain (22.7%) or lung (20.7%). ctDNA obtained from most patients (N = 423 (63%)) displayed at least 1 alteration...
August 14, 2017: Cancer Research
https://www.readbyqxmd.com/read/28807787/trigeminal-nerve-stimulation-induces-fos-immunoreactivity-in-selected-brain-regions-increases-hippocampal-cell-proliferation-and-reduces-seizure-severity-in-rats
#12
Beniamina Mercante, Paolo Enrico, Gabriele Floris, Marina Quartu, Marianna Boi, Maria Pina Serra, Paolo Follesa, Franca Deriu
Sites and mechanisms by which trigeminal nerve stimulation (TNS) exerts beneficial effects on symptoms of drug-resistant epilepsy and depression are still unknown. Effects of short-term TNS on brain regions involved in the physiopathology of these disorders were investigated in this study. Forty male rats were assigned to 3 groups: TNS (undergoing electrical stimulation of the left infraorbitary nerve via surgically implanted cuff electrodes); Sham (undergoing surgical procedure but without a stimulation); Naïve rats...
August 11, 2017: Neuroscience
https://www.readbyqxmd.com/read/28806440/considerations-on-the-off-label-use-of-ketamine-as-a-treatment-for-mood-disorders
#13
Samuel T Wilkinson, Gerard Sanacora
No abstract text is available yet for this article.
August 14, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28805563/infusional-therapies-continuous-dopaminergic-stimulation-and-nonmotor-symptoms
#14
Ulrika Mundt-Petersen, Per Odin
Pump-based Parkinson (PD) therapies, including subcutaneous apomorphine infusion (CSA) and levodopa-carbidopa intestinal gel (LCIG), presently constitute the most effective pharmacological treatments available for advanced PD. These therapies are based on a more constant delivery of the dopaminergic drug resulting in a more continuous dopaminergic stimulation and a more stable treatment effect. This can be detected as reduction of time in off, reduction of dyskinesia frequency and severity, as well as increase of time in on without troublesome dyskinesias...
2017: International Review of Neurobiology
https://www.readbyqxmd.com/read/28802075/overcoming-severe-adverse-reactions-to-venom-immunotherapy-by-using-anti-ige-antibodies-in-combination-with-a-high-maintenance-dose
#15
Eva Stretz, Eva Maria Oppel, Räwer Helen-Caroline, René Chatelain, Sebastian Mastnik, Bernhard Przybilla, Franziska Ruëff
BACKGROUND: An omalizumab treatment and a high maintenance venom dose may both help to prevent recurrent systemic allergic reactions (SAR) to venom immunotherapy (VIT). The effectiveness of this combination therapy, however, is unclear. OBJECTIVE: We wanted to explore the possibility whether a temporary treatment with the anti-IgE antibody omalizumab, combined with a VIT using an elevated maintenance dose of >100 μg venom may establish a permanent tolerance of maintenance VIT...
August 12, 2017: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28801787/reduction-of-68-ga-psma-renal-uptake-with-mannitol-infusion-preliminary-results
#16
Federica Matteucci, Emilio Mezzenga, Paola Caroli, Valentina Di Iorio, Anna Sarnelli, Monica Celli, Lorenzo Fantini, Andrea Moretti, Riccardo Galassi, Ugo De Giorgi, Giovanni Paganelli
PURPOSE: Urea-based prostate-specific membrane antigen (PSMA) ligands labelled with (68)Ga or (177)Lu are new tracers with great potential for theranostic approaches in prostate cancer. However, clinical studies have shown that the kidneys are one of the off-target organs along with the salivary and lacrimal glands. In the kidneys, PSMA is physiologically expressed in the apical epithelium of the proximal tubules, and mannitol acts as an osmotic diuretic in these tubules. We investigated the potential of mannitol to reduce renal uptake of (68)Ga-PSMA...
August 11, 2017: European Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/28799408/assessment-of-apixaban-prescribing-patterns-for-nonvalvular-atrial-fibrillation-in-hospitalized-patients
#17
Caitlin M Gibson, Carmen B Smith, Sondra Davis, Michael J Scalese
BACKGROUND: Apixaban is a direct oral anticoagulant (DOAC) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Other DOACs require renal dose adjustments based solely on creatinine clearance. Apixaban differs in that its dose adjustments are more complex, potentially leading to prescribing errors. OBJECTIVE: To determine if adherence to Food and Drug Administration (FDA)-approved dosing for apixaban is maintained in hospitalized patients with NVAF...
August 1, 2017: Annals of Pharmacotherapy
https://www.readbyqxmd.com/read/28799040/automated-microfluidic-devices-integrating-solid-phase-extraction-fluorescent-labeling-and-microchip-electrophoresis-for-preterm-birth-biomarker-analysis
#18
Vishal Sahore, Mukul Sonker, Anna V Nielsen, Radim Knob, Suresh Kumar, Adam T Woolley
We have developed multichannel integrated microfluidic devices for automated preconcentration, labeling, purification, and separation of preterm birth (PTB) biomarkers. We fabricated multilayer poly(dimethylsiloxane)-cyclic olefin copolymer (PDMS-COC) devices that perform solid-phase extraction (SPE) and microchip electrophoresis (μCE) for automated PTB biomarker analysis. The PDMS control layer had a peristaltic pump and pneumatic valves for flow control, while the PDMS fluidic layer had five input reservoirs connected to microchannels and a μCE system...
August 10, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/28796916/fragrance-contact-allergens-in-5-588-cosmetic-products-identified-through-a-novel-smartphone-application
#19
Niels Højsager Bennike, Nikoline Bang Oturai, Stine Müller, Christel Søgaard Kirkeby, Claus Jørgensen, Anne Beck Christensen, Claus Zachariae, Jeanne Duus Johansen
BACKGROUND: More than 25% of the adult European population suffers from contact allergy, with fragrance substances recognized as one of the main causes. Since 2005, 26 fragrance contact allergens have been mandatory to label in cosmetic products within the EU if present at 10 ppm or above in leave-on and 100 ppm or above in wash-off cosmetics. OBJECTIVE: To examine exposure, based on ingredient labelling, to the 26 fragrances in a sample of 5,588 fragranced cosmetic products...
August 10, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28796415/white-matter-tract-integrity-is-associated-with-antidepressant-response-to-lurasidone-in-bipolar-depression
#20
Martin J Lan, Harry Rubin-Falcone, Fatima Motiwala, Ying Chen, Jonathan W Stewart, David J Hellerstein, J John Mann, Patrick J McGrath
OBJECTIVES: Patients with bipolar disorder spend the most time in the depressed phase, and that phase is associated with the most morbidity and mortality. Treatment of bipolar depression lacks a test to determine who will respond to treatment. White matter disruptions have been found in bipolar disorder. Previous reports suggest that white matter disruptions may be associated with resistance to antidepressant medication, but this has never been investigated in a prospective study using a Food and Drug Administration (FDA)-approved medication...
August 10, 2017: Bipolar Disorders
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