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https://www.readbyqxmd.com/read/28108511/biomarker-based-pet-imaging-of-diffuse-intrinsic-pontine-glioma-in-mouse-models
#1
Susanne Kossatz, Brandon Carney, Melanie E Schweitzer, Giuseppe Carlucci, Vesselin Miloushev, Uday B Maachani, Prajwal Rajappa, Kayvan Keshari, David J Pisapia, Wolfgang A Weber, Mark M Souweidane, Thomas Reiner
Diffuse intrinsic pontine glioma (DIPG) is a childhood brainstem tumor with a universally poor prognosis. Here, we characterize on a positron emission tomography (PET) probe for imaging DIPG in vivo. In human histological tissues, the probes target, poly(ADP)ribose polymerase 1 (PARP1), was highly expressed in DIPG compared to normal brain. PET imaging allowed for the sensitive detection of DIPG in a genetically engineered mouse model (GEMM), and probe uptake correlated to histologically determined tumor infiltration...
January 20, 2017: Cancer Research
https://www.readbyqxmd.com/read/28108232/ns5a-resistance-associated-substitutions-in-patients-with-genotype-1-hepatitis-c-virus-prevalence-and-effect-on-treatment-outcome
#2
Stefan Zeuzem, Masashi Mizokami, Stephen Pianko, Alessandra Mangia, Kwang-Hyub Han, Ross Martin, Evguenia Svarovskaia, Hadas Dvory-Sobol, Brian Doehle, Charlotte Hedskog, Chohee Yun, Diana M Brainard, Steven Knox, John G McHutchison, Michael D Miller, Hongmei Mo, Wan-Long Chuang, Ira Jacobson, Gregory J Dore, Mark Sulkowski
BACKGROUND: The efficacy of NS5A inhibitors for the treatment of patients chronically infected with hepatitis C virus (HCV) can be affected by the presence of NS5A resistance-associated substitutions (RASs). We analyzed data from 35 phase 1, 2, and 3 studies in 22 countries to determine the pretreatment prevalence of various NS5A RASs, and their effect on outcomes of treatment with ledipasvir-sofosbuvir in patients with genotype 1 HCV. METHODS: NS5A gene deep sequencing analysis was performed on samples from 5,397 patients in Gilead clinical trials...
January 17, 2017: Journal of Hepatology
https://www.readbyqxmd.com/read/28107846/the-effectiveness-of-breathing-patterns-to-control-maternal-anxiety-during-the-first-period-of-labor-a-randomized-controlled-clinical-trial
#3
REVIEW
A Boaviagem, E Melo Junior, L Lubambo, P Sousa, C Aragão, S Albuquerque, A Lemos
OBJECTIVE: Assess the efficacy of the breathing patterns during the active phase of the first stage of labor for maternal anxiety. DESING: Randomised trial with two treatment arms and intention-to-treat analysis. PARTICIPANTS: One Hundred and forty patient in active labour, age between 12 and 40 years old and gestational age between 37 and 41 weeks. The breathing patterns waere made depending on the dilation phase and intensity of contraction, while the control group received routine care service...
February 2017: Complementary Therapies in Clinical Practice
https://www.readbyqxmd.com/read/28107821/effects-of-a-single-20%C3%A2-mg-dose-of-letrozole-on-ovarian-function-post-dominant-follicle-selection-an-exploratory-randomized-controlled-trial
#4
H C M Allaway, D R Chizen, G P Adams, R A Pierson
BACKGROUND: Our objective was to explore the impact of a single dose of an aromatase inhibitor (letrozole) administered at defined times of the follicular phase or immediately after ovulation on dominant follicle development, luteogenesis and new follicle wave emergence. METHODS: A prospective pilot study using a randomized complete block, controlled, open label design was conducted at an academic clinical research center. Forty-five healthy, female volunteers (25...
January 21, 2017: Journal of Ovarian Research
https://www.readbyqxmd.com/read/28107664/safety-and-efficacy-of-cardiopoietic-stem-cells-in-the-treatment-of-post-infarction-left-ventricular-dysfunction-from-cardioprotection-to-functional-repair-in-a-translational-pig-infarction-model
#5
Maximilian Y Emmert, Petra Wolint, Andras Jakab, Sean P Sheehy, Francesco S Pasqualini, Thi Dan Linh Nguyen, Monika Hilbe, Burkhardt Seifert, Benedikt Weber, Chad E Brokopp, Dominika Macejovska, Etem Caliskan, Arnold von Eckardstein, Ruth Schwartlander, Viola Vogel, Volkmar Falk, Kevin Kit Parker, Mariann Gyöngyösi, Simon P Hoerstrup
To date, clinical success of cardiac cell-therapies remains limited. To enhance the cardioreparative properties of stem cells, the concept of lineage-specification through cardiopoietic-guidance has been recently suggested. However, so far, only results from murine studies and from a clinical pilot-trial in chronic heart-failure (CHF) are available, while systematic evidence of its therapeutic-efficacy is still lacking. Importantly, also no data from large animals or for other indications are available. Therefore, we here investigate the therapeutic-efficacy of human cardiopoietic stem cells in the treatment of post-infarction LV-dysfunction using a translational pig-model...
November 23, 2016: Biomaterials
https://www.readbyqxmd.com/read/28107570/efficacy-and-safety-of-interleukin-17-antagonists-in-patients-with-plaque-psoriasis-a-meta-analysis-from-phase-3-randomized-controlled-trails
#6
Dan Wu, Si-Yuan Hou, Shuai Zhao, Lin-Xin Hou, Ting Jiao, Nan-Nan Xu, Ning Zhang
BACKGROUND: The interleukin-17 (IL-17) cytokine pathway plays a key role in the development of psoriasis. Antibodies targeting IL-17 or blocking its receptor may be a new therapeutic approach for psoriasis. To assist treatment selection in daily practice it is essential to understand the benefit and risk profile of IL-17 antagonists. OBJECTIVE: We performed a meta-analysis to evaluate the efficacy and safety of IL-17 antagonists in patients with psoriasis. METHODS: We searched a number of databases for relevant randomized clinical trials (RCTs) published before May 2016...
January 20, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28105588/nogo-a-antibodies-for-progressive-multiple-sclerosis
#7
Benjamin V Ineichen, Patricia S Plattner, Nicolas Good, Roland Martin, Michael Linnebank, Martin E Schwab
Most of the current therapies, as well as many of the clinical trials, for multiple sclerosis (MS) target the inflammatory autoimmune processes, but less than 20% of all clinical trials investigate potential therapies for the chronic progressive disease stage of MS. The latter is responsible for the steadily increasing disability in many patients, and there is an urgent need for novel therapies that protect nervous system tissue and enhance axonal growth and/or remyelination. As outlined in this review, solid pre-clinical data suggest neutralization of the neurite outgrowth inhibitor Nogo-A as a potential new way to achieve both axonal and myelin repair...
January 19, 2017: CNS Drugs
https://www.readbyqxmd.com/read/28104437/pharmacological-intervention-for-dengue-virus-infection
#8
REVIEW
Jenn-Haung Lai, Yi-Ling Lin, Shie-Liang Hsieh
Dengue virus (DENV) infection has a considerable health impact in tropical and subtropical countries worldwide. Escalation of infection rates greatly increases morbidity and mortality, most commonly from deaths due to dengue hemorrhagic fever and dengue shock syndrome. Although the development of an effective, long-lasting vaccine has been a major aim for control and prevention of DENV infection, the currently licensed vaccine has limitations and is less than satisfactory. Thus, there remains an important need to identify effective and tolerable medications for treatment of DENV-infected patients both in the early phase, to prevent progression to fatal outcomes, and to minimize deaths after patients develop severe complications...
January 16, 2017: Biochemical Pharmacology
https://www.readbyqxmd.com/read/28104251/efficacy-safety-and-pharmacokinetics-of-natalizumab-in-japanese-multiple-sclerosis-patients-a-double-blind-randomized-controlled-trial-and-open-label-pharmacokinetic-study
#9
Takahiko Saida, Jun-Ichi Kira, Shuji Kishida, Takashi Yamamura, Yukiko Sudo, Kazutaka Ogiwara, J T Tibung, Nisha Lucas, Meena Subramanyam
BACKGROUND: Natalizumab, an anti-α4 integrin monoclonal antibody, has demonstrated efficacy in phase 2 and 3 studies of predominantly Caucasian patients with relapsing-remitting multiple sclerosis (RRMS). OBJECTIVE: To evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of natalizumab in Japanese RRMS patients. METHODS: This multicenter, phase 2 study included an open-label PK/PD study in 12 patients (part A) and a double-blind, placebo-controlled, randomized (computer-generated sequence) study in 94 patients (part B)...
January 2017: Multiple Sclerosis and related Disorders
https://www.readbyqxmd.com/read/28103611/phase-ii-randomised-discontinuation-trial-of-the-met-vegf-receptor-inhibitor-cabozantinib-in-metastatic-melanoma
#10
Adil Daud, Harriet M Kluger, Razelle Kurzrock, Frauke Schimmoller, Aaron L Weitzman, Thomas A Samuel, Ali H Moussa, Michael S Gordon, Geoffrey I Shapiro
BACKGROUND: A phase II randomised discontinuation trial assessed cabozantinib (XL184), an orally bioavailable inhibitor of tyrosine kinases including VEGF receptors, MET, and AXL, in a cohort of patients with metastatic melanoma. METHODS: Patients received cabozantinib 100 mg daily during a 12-week lead-in. Patients with stable disease (SD) per Response Evaluation Criteria in Solid Tumours (RECIST) at week 12 were randomised to cabozantinib or placebo. Primary endpoints were objective response rate (ORR) at week 12 and postrandomisation progression-free survival (PFS)...
January 19, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28103052/adjunctive-treatment-of-psychotic-disorders-with-micronutrients
#11
Lewis Mehl-Madrona, Barbara Mainguy
OBJECTIVE: To evaluate the effect of micronutrients (minerals and vitamins) on adult psychosis when added to conventional medications by using a placebo-controlled randomized design with a 1-month open-label run-in. DESIGN: Longitudinal comparison study following a randomized, controlled trial that had failed because participants declined to undergo randomization. Setting/Locations: Rural primary care and psychiatry clinic in northern New England (town of 16,000 people)...
January 19, 2017: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/28102887/clinical-trial-of-nintedanib-in-patients-with-recurrent-or-metastatic-salivary-gland-cancer-of-the-head-and-neck-a-multicenter-phase-2-study-korean-cancer-study-group-hn14-01
#12
Youjin Kim, Su Jin Lee, Ji Yun Lee, Se-Hoon Lee, Jong-Mu Sun, Keunchil Park, Ho Jung An, Jae Yong Cho, Eun Joo Kang, Ha-Young Lee, Jinsoo Kim, Bhumsuk Keam, Hye Ryun Kim, Kyoung Eun Lee, Moon Young Choi, Ki Hyeong Lee, Myung-Ju Ahn
BACKGROUND: Salivary gland cancers (SGCs) are uncommon and account for less than 5% of all head and neck cancers, but they are histologically heterogeneous. No specific therapy, including targeted agents, has consistently improved clinical outcomes in recurrent/metastatic SGC. Recent studies suggest that vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR) play important roles in SGC. Nintedanib is a potent small-molecule, triple-receptor tyrosine kinase inhibitor (VEGFR1, VEGFR2, and VEGFR3; fibroblast growth factor receptor 1 [FGFR1], FGFR2, and FGFR3; and PDGFRα and PDGFRß)...
January 19, 2017: Cancer
https://www.readbyqxmd.com/read/28100580/venetoclax-in-patients-with-previously-treated-chronic-lymphocytic-leukemia
#13
Andrew W Roberts, Stephan Stilgenbauer, John F Seymour, David C S Huang
Venetoclax is the first BCL2 inhibitor to enter routine clinical practice. It is an orally bioavailable small molecule that binds BCL2 very specifically. Acting as a pharmacological mimic of the proteins that initiate apoptosis (a so-called BH3-mimetic), venetoclax rapidly induces apoptosis in chronic lymphocytic leukemia (CLL) cells which express high levels of BCL2 and rely on it to maintain their survival. As a single agent, daily venetoclax treatment induced durable responses in 79% of patients with relapsed or refractory CLL or small lymphocytic lymphoma in a Phase 1 study, including complete remissions in 20% of patients...
January 18, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28099485/cell-based-systems-biology-analysis-of-human-as03-adjuvanted-h5n1-avian-influenza-vaccine-responses-a-phase-i-randomized-controlled-trial
#14
Leigh M Howard, Kristen L Hoek, Johannes B Goll, Parimal Samir, Allison Galassie, Tara M Allos, Xinnan Niu, Laura E Gordy, C Buddy Creech, Nripesh Prasad, Travis L Jensen, Heather Hill, Shawn E Levy, Sebastian Joyce, Andrew J Link, Kathryn M Edwards
BACKGROUND: Vaccine development for influenza A/H5N1 is an important public health priority, but H5N1 vaccines are less immunogenic than seasonal influenza vaccines. Adjuvant System 03 (AS03) markedly enhances immune responses to H5N1 vaccine antigens, but the underlying molecular mechanisms are incompletely understood. OBJECTIVE AND METHODS: We compared the safety (primary endpoint), immunogenicity (secondary), gene expression (tertiary) and cytokine responses (exploratory) between AS03-adjuvanted and unadjuvanted inactivated split-virus H5N1 influenza vaccines...
2017: PloS One
https://www.readbyqxmd.com/read/28097904/estimated-burden-of-cardiovascular-disease-and-value-based-price-range-for-evolocumab-in-a-high-risk-secondary-prevention-population-in-the-us-payer-context
#15
Peter P Toth, Mark Danese, Guillermo Villa, Yi Qian, Anne Beaubrun, Armando Lira, Jeroen P Jansen
AIM: To estimate real-world cardiovascular disease (CVD) burden and value-based price range of evolocumab for a US-context, high-risk, secondary-prevention population. MATERIALS AND METHODS: Burden of CVD was assessed using the UK-based Clinical Practice Research Datalink (CPRD) in order to capture complete CV burden including CV mortality. Patients on standard of care (SOC; high-intensity statins) in CPRD were selected based on eligibility criteria of FOURIER, a phase 3 CV outcomes trial of evolocumab, and categorized into 4 cohorts: high-risk prevalent atherosclerotic CVD (ASCVD) cohort (N = 1448), acute coronary syndrome (ACS) (N = 602), ischemic stroke (IS) (N = 151), and heart failure (HF) (N = 291) incident cohorts...
January 18, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28097641/natural-products-diversity-of-marine-ascidians-tunicates-ascidiacea-and-successful-drugs-in-clinical-development
#16
REVIEW
Satheesh Kumar Palanisamy, N M Rajendran, Angela Marino
This present study reviewed the chemical diversity of marine ascidians and their pharmacological applications, challenges and recent developments in marine drug discovery reported during 1994-2014, highlighting the structural activity of compounds produced by these specimens. Till date only 5% of living ascidian species were studied from <3000 species, this study represented from family didemnidae (32%), polyclinidae (22%), styelidae and polycitoridae (11-12%) exhibiting the highest number of promising MNPs...
January 17, 2017: Natural Products and Bioprospecting
https://www.readbyqxmd.com/read/28097629/radiomitigation-and-tissue-repair-activity-of-systemically-administered-therapeutic-peptide-tp508-is-enhanced-by-pegylation
#17
Scott D McVicar, Kempaiah Rayavara, Darrell H Carney
TP508 is a synthetically derived tissue repair peptide that has previously demonstrated safety and potential efficacy in phase I/II clinical trials for the treatment of diabetic foot ulcers. Recent studies show that a single injection of TP508 administered 24 h after irradiation significantly increases survival and delays mortality in murine models of acute radiation mortality. Thus, TP508 is being developed as a potential nuclear countermeasure. Because of the short plasma half-life of TP508, we hypothesize that increasing the peptide bioavailability would increase TP508 efficacy or reduce the dosage required for therapeutic effects...
January 17, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28096679/a-phase-ii-single-arm-trial-of-palonosetron-for-the-prevention-of-acute-and-delayed-chemotherapy-induced-nausea-and-vomiting-in-malignant-glioma-patients-receiving-multidose-irinotecan-in-combination-with-bevacizumab
#18
Mary Lou Affronti, Sarah Woodring, Katherine B Peters, James E Herndon, Frances McSherry, Patrick N Healy, Annick Desjardins, James J Vredenburgh, Henry S Friedman
PURPOSE: Given that the prognosis of recurrent malignant glioma (MG) remains poor, improving quality of life (QoL) through symptom management is important. Meta-analyses establishing antiemetic guidelines have demonstrated the superiority of palonosetron (PAL) over older 5-hydroxytryptamine 3-receptor antagonists in chemotherapy-induced nausea and vomiting (CINV) prevention, but excluded patients with gliomas. Irinotecan plus bevacizumab is a treatment frequently used in MG, but is associated with low (55%) CINV complete response (CR; no emesis or use of rescue antiemetic) with commonly prescribed ondansetron...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28096255/sheppheartcabg-trial-comprehensive-early-rehabilitation-after-coronary-artery-bypass-grafting-a-protocol-for-a-randomised-clinical-trial
#19
Ida Elisabeth Højskov, Philip Moons, Niels Viggo Hansen, Søren La Cour, Peter Skov Olsen, Christian Gluud, Per Winkel, Jane Lindschou, Lau Caspar Thygesen, Ingrid Egerod, Selina Kikkenborg Berg
INTRODUCTION: Patients undergoing coronary artery bypass graft surgery often experience a range of symptoms. Studies indicate that non-pharmacological interventions such as exercise training and psychoeducation have a positive physiological and psychological effect in early outpatient rehabilitation. The SheppHeartCABG trial will investigate the effect of early comprehensive rehabilitation in early phase rehabilitation versus usual care. The aim of this paper is to present the protocol for the SheppHeartCABG trial...
January 17, 2017: BMJ Open
https://www.readbyqxmd.com/read/28096109/financial-ties-of-principal-investigators-and-randomized-controlled-trial-outcomes-cross-sectional-study
#20
Rosa Ahn, Alexandra Woodbridge, Ann Abraham, Susan Saba, Deborah Korenstein, Erin Madden, W John Boscardin, Salomeh Keyhani
OBJECTIVE:  To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding. DESIGN:  Cross sectional study of randomized controlled trials (RCTs). SETTING:  Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013. PARTICIPANTS:  Random sample of RCTs focused on drug efficacy...
January 17, 2017: BMJ: British Medical Journal
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