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https://www.readbyqxmd.com/read/29222947/safety-and-efficacy-of-guselkumab-in-japanese-patients-with-moderate-to-severe-plaque-psoriasis-a-randomised-placebo-controlled-ascending-dose-study
#1
O Nemoto, K Hirose, S Shibata, K Li, H Kubo
BACKGROUND: The Interlukin-23 (IL-23)/Interlukin-17 (IL-17) pathway is central in the pathogenesis of psoriasis. The favourable efficacy and safety of guselkumab, an IL-23 specific monoclonal antibody, has been demonstrated in global Phase 3 studies of plaque psoriasis. OBJECTIVES: To evaluate the safety, efficacy and pharmacokinetics of a single-dose subcutaneous guselkumab in Japanese patients with moderate-to-severe plaque psoriasis. METHODS: Patients with ≥ 10% of total body surface area (BSA) involvement and a Psoriasis Area and Severity Index (PASI) ≥12 were randomised (5:1) to receive guselkumab or placebo in 4 cohorts of this double-blind, placebo-controlled, single ascending dose, single-centre study...
December 9, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/29222696/thrombomodulin-favors-leukocyte-microvesicle-fibrinolytic-activity-reduces-netosis-and-prevents-septic-shock-induced-coagulopathy-in-rats
#2
Julie Helms, Raphaël Clere-Jehl, Elsa Bianchini, Pierrick Le Borgne, Mélanie Burban, Fatiha Zobairi, Jean-Luc Diehl, Lelia Grunebaum, Florence Toti, Ferhat Meziani, Delphine Borgel
BACKGROUND: Septic shock-induced disseminated intravascular coagulation is responsible for increased occurrence of multiple organ dysfunction and mortality. Immunothrombosis-induced coagulopathy may contribute to hypercoagulability. We aimed at determining whether recombinant human thrombomodulin (rhTM) could control exaggerated immunothrombosis by studying procoagulant responses, fibrinolysis activity borne by microvesicles (MVs) and NETosis in septic shock. METHODS: In a septic shock model after a cecal ligation and puncture-induced peritonitis (H0), rats were treated with rhTM or a placebo at H18, resuscitated and monitored during 4 h...
December 8, 2017: Annals of Intensive Care
https://www.readbyqxmd.com/read/29222670/venetoclax-for-treating-chronic-lymphocytic-leukaemia-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#3
REVIEW
Hema Mistry, Chidozie Nduka, Martin Connock, Jill Colquitt, Theodoros Mantopoulos, Emma Loveman, Renata Walewska, James Mason
Venetoclax is licensed to treat relapsed or refractory (R/R) chronic lymphocytic leukaemia (CLL). As part of the Single Technology Appraisal (STA) ID944, the National Institute for Health and Care Excellence (NICE) invited AbbVie, the manufacturer, to submit evidence on the use of venetoclax, within its licensed indication. The Evidence Review Group (ERG), Warwick Evidence, was asked to provide an independent and critical review of the submitted evidence. Evidence came from three single-arm trials in CLL patients with or without 17p deletion [del(17p])/TP53 chromosomal abnormalities...
December 8, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29222031/evaluation-of-the-effect-of-mesotherapy-in-the-management-of-back-pain-in-police-working-dog
#4
João Ca Alves, Ana Mmp Dos Santos, Ângelo Dp Fernandes
OBJECTIVE: To evaluate the feasibility and effectiveness of mesotherapy in dogs compared with a positive control group. STUDY DESIGN: Experimental, randomized, blinded study. ANIMALS: Fifteen working police dogs with chronic back pain. METHODS: Animals were divided randomly into control (CG; n = 5) and treatment groups (TG; n = 10). A combination of 140 mg lidocaine, 15 mg dexamethasone and 20 mg thiocolchicoside was administered to group TG along with a 70-day course of a placebo, administered as if it was carprofen...
August 19, 2017: Veterinary Anaesthesia and Analgesia
https://www.readbyqxmd.com/read/29221713/effect-of-grass-sublingual-tablet-immunotherapy-is-similar-in-children-and-adults-a-bayesian-approach-to-design-pediatric-sublingual-immunotherapy-trials
#5
Amarjot Kaur, David Skoner, Joseph Ibrahim, Qing Li, Richard F Lockey, Michael Blaiss, Albrecht Bufe, Jens Strodl Andersen, Giorgio Walter Canonica, Hendrik Nolte
BACKGROUND: Large sample sizes are needed for sublingual immunotherapy (SLIT) trials due to inherent data variability secondary to inconsistent allergen exposure. Obtaining large sample sizes for pediatric SLIT trials is challenging, but a Bayesian approach using prior adult data can reduce the necessary sample size. OBJECTIVE: To describe how a Bayesian framework utilizing prior information from adult trials can be used to improve pediatric SLIT clinical development...
December 5, 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/29220524/brain-responses-to-cigarette-related-and-emotional-images-in-smokers-during-smoking-cessation-no-effect-of-varenicline-or-bupropion-on-the-late-positive-potential
#6
Francesco Versace, Elise M Stevens, Jason D Robinson, Yong Cui, Menton M Deweese, Jeffrey M Engelmann, Charles E Green, Maher Karam-Hage, Cho Y Lam, Jennifer A Minnix, David W Wetter, Paul M Cinciripini
Introduction: Varenicline and bupropion are two effective smoking cessation pharmacotherapies. Researchers have hypothesized that they might be effective, in part, because they reduce cue reactivity and cue-induced cravings. Here, we used event-related potentials (ERPs) to directly measure brain responses to cigarette-related and other motivationally relevant images during a pharmacologically aided quit attempt. Methods: Smokers involved in a 12-week placebo-controlled double-blind clinical trial of smoking cessation medications (varenicline, bupropion, placebo) took part in the study...
December 6, 2017: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/29218326/study-protocol-a-multi-centre-double-blind-randomised-placebo-controlled-parallel-group-phase-ii-trial-ridd-to-determine-the-efficacy-of-intra-nodular-injection-of-anti-tnf-to-control-disease-progression-in-early-dupuytren-s-disease-with-an-embedded-dose-response
#7
Jagdeep Nanchahal, Catherine Ball, Jennifer Swettenham, Susan Dutton, Vicki Barber, Joanna Black, Bethan Copsey, Melina Dritsaki, Peter Taylor, Alastair Gray, Marc Feldmann, Sarah Lamb
Dupuytren's disease is a common fibrotic condition of the hand affecting 4% of the population and causes the fingers to curl irreversibly into the palm. It has a strong familial tendency, there is no approved treatment for early stage disease, and patients with established digital contractures are most commonly treated by surgery. This is associated with prolonged recovery, and less invasive techniques have high recurrence rates.The myofibroblasts, the cells responsible for the excessive matrix deposition and contraction, are aggregated in nodules...
2017: Wellcome Open Research
https://www.readbyqxmd.com/read/29216203/dose-responses-of-vitamin-d3-supplementation-on-arterial-stiffness-in-overweight-african-americans-with-vitamin-d-deficiency-a-placebo-controlled-randomized-trial
#8
Anas Raed, Jigar Bhagatwala, Haidong Zhu, Norman K Pollock, Samip J Parikh, Ying Huang, Robyn Havens, Ishita Kotak, De-Huang Guo, Yanbin Dong
BACKGROUND: Clinical trials are scant and equivocal on whether vitamin D can ameliorate arterial stiffness, particularly in populations at high risk for vitamin D deficiency and cardiovascular disease (CVD). This study determined the dose-response effects of vitamin D3 supplementation on arterial stiffness in overweight African Americans with vitamin D deficiency. METHODS: Seventy overweight African Americans (aged 13-45 years) with serum 25-hydroxyvitamin D [25(OH)D] levels ≤ 20 ng/mL were randomized to monthly oral supplementation of 18,000 IU (~600 IU/day, n = 17), 60,000 IU (~2000 IU/day, n = 18), or 120,000 IU (~4000 IU/day, n = 18) of vitamin D3 or placebo (n = 17) for 16-weeks...
2017: PloS One
https://www.readbyqxmd.com/read/29214924/different-protein-and-derivatives-supplementation-strategies-combined-with-resistance-training-in-pre-frail-and-frail-elderly-rationale-and-protocol-for-the-pro-elderly-study
#9
Alan Lins Fernandes, Ana Paula Hayashi, José Claudio Jambassi-Filho, Mariana Dutilh de Capitani, Davi Alves de Santana, Bruno Gualano, Hamilton Roschel
BACKGROUND: Frailty is a multifactorial geriatric syndrome characterized by progressive decline in health and associated with decreased muscle mass, strength, and functional capacity. Resistance training (RT) combined with protein or amino acids supplementation has been shown to be promising for mitigating age-related impairments. AIM: To investigate the chronic effects of different strategies of protein and derivatives supplementation in association with RT on selected health-related parameters in pre-frail and frail elderly...
December 2017: Nutrition and Health
https://www.readbyqxmd.com/read/29214639/cannabinoids-for-epilepsy-what-do-we-know-and-where-do-we-go
#10
REVIEW
Martin J Brodie, Elinor Ben-Menachem
Over the past decade there has been an increasing interest in using cannabinoids to treat a range of epilepsy syndromes following reports of some remarkable responses in individual patients. The situation is complicated by the fact that these agents do not appear to work via their attachment to endogenous cannabinoid receptors. Their pharmacokinetics are complex, and bioavailability is variable, resulting in difficulty in developing a suitable formulation for oral delivery. Drug interactions also represent another complication in their everyday use...
December 6, 2017: Epilepsia
https://www.readbyqxmd.com/read/29214034/identification-of-biomarkers-of-response-to-abatacept-in-patients-with-sle-using-deconvolution-of-whole-blood-transcriptomic-data-from-a-phase-iib-clinical-trial
#11
Somnath Bandyopadhyay, Sean E Connolly, Omar Jabado, June Ye, Sheila Kelly, Michael A Maldonado, Rene Westhovens, Peter Nash, Joan T Merrill, Robert M Townsend
Objective: To characterise patients with active SLE based on pretreatment gene expression-defined peripheral immune cell patterns and identify clusters enriched for potential responders to abatacept treatment. Methods: This post hoc analysis used baseline peripheral whole blood transcriptomic data from patients in a phase IIb trial of intravenous abatacept (~10 mg/kg/month). Cell-specific genes were used with a published deconvolution algorithm to identify immune cell proportions in patient samples, and unsupervised consensus clustering was generated...
2017: Lupus Science & Medicine
https://www.readbyqxmd.com/read/29214012/evidence-of-the-efficacy-and-safety-of-house-dust-mite-subcutaneous-immunotherapy-in-elderly-allergic-rhinitis-patients-a-randomized-double-blind-placebo-controlled-trial
#12
Andrzej Bożek, Krzysztof Kołodziejczyk, Renata Kozłowska, Giorgio Walter Canonica
Background: Allergen specific immunotherapy (AIT) in elderly patients is controversial, and there is still little evidence supporting the safety and efficacy of this treatment in this population. The study objective was to evaluate the safety and efficacy of AIT for house dust mite allergens in patients over 65 years of age with allergic rhinitis (AR) and a documented allergy to house dust mites. The primary endpoint was the change from baseline in the mean average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS) difference in the least square means for the label compared to placebo...
2017: Clinical and Translational Allergy
https://www.readbyqxmd.com/read/29212716/a-randomized-controlled-safety-efficacy-trial-of-therapeutic-vaccination-in-hiv-infected-individuals-who-initiated-antiretroviral-therapy-early-in-infection
#13
Michael C Sneller, J Shawn Justement, Kathleen R Gittens, Mary E Petrone, Katherine E Clarridge, Michael A Proschan, Richard Kwan, Victoria Shi, Jana Blazkova, Eric W Refsland, Daryl E Morris, Kristen W Cohen, M Juliana McElrath, Rong Xu, Michael A Egan, John H Eldridge, Erika Benko, Colin Kovacs, Susan Moir, Tae-Wook Chun, Anthony S Fauci
Despite substantial clinical benefits, complete eradication of HIV has not been possible using antiretroviral therapy (ART) alone. Strategies that can either eliminate persistent viral reservoirs or boost host immunity to prevent rebound of virus from these reservoirs after discontinuation of ART are needed; one possibility is therapeutic vaccination. We report the results of a randomized, placebo-controlled trial of a therapeutic vaccine regimen in patients in whom ART was initiated during the early stage of HIV infection and whose immune system was anticipated to be relatively intact...
December 6, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/29212515/psychometric-properties-of-morning-joint-stiffness-duration-and-severity-measures-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis
#14
Elizabeth D Bacci, Amy M DeLozier, Chen-Yen Lin, Carol L Gaich, Terence Rooney, Richard Hoffman, Kathleen W Wyrwich
BACKGROUND: To assess the measurement properties of two single-item patient-reported outcome (PRO) measures that assessed the length of time (in minutes) and severity of morning joint stiffness (MJS) experienced each day. METHODS: Data from two Phase 3, randomized placebo-controlled (and active-controlled [RA-BEAM]), clinical studies assessing the safety and efficacy of baricitinib in adults with moderately to severely active rheumatoid arthritis (RA) were used to evaluate the psychometric properties of the Duration of MJS and Severity of MJS PROs...
December 6, 2017: Health and Quality of Life Outcomes
https://www.readbyqxmd.com/read/29211866/association-of-urinary-citrate-with-acid-base-status-bone-resorption-and-calcium-excretion-in-older-men-and-women
#15
M Kyla Shea, Bess Dawson-Hughes
Context: Elevated urine net acid excretion (NAE), indicative of subclinical metabolic acidosis, has been associated with higher bone turnover. While NAE is the gold-standard clinical measure of acid-base status, it is impractical to measure in most clinical/research settings. Urine citrate, which is commonly measured, changes in response to acid-base status, but its association with bone turnover is uncertain. Objective: To evaluate the association between change in urine citrate and change in bone turnover and calcium excretion...
December 1, 2017: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29211505/the-effect-of-dietary-nitrate-on-nocturnal-sleep-disordered-breathing-and-arterial-oxygen-desaturation-at-high-altitude
#16
Alexander Patrician, Harald Engan, David Lundsten, Ludger Grote, Helena Vigetun-Haughey, Erika Schagatay
Patrician, Alexander, Harald Engan, David Lundsten, Ludger Grote, Helena Vigetun-Haughey, and Erika Schagatay. The effect of dietary nitrate on nocturnal sleep-disordered breathing and arterial oxygen desaturation at high altitude. High Alt Med Biol 00:000-000, 2017.-Sleep-disordered breathing and fluctuations in arterial oxygen saturation (SaO2) are common during sleep among lowlanders ascending to high altitude. Dietary nitrate (NO3-) supplementation has been shown to lower the O2 consumption in various conditions...
December 6, 2017: High Altitude Medicine & Biology
https://www.readbyqxmd.com/read/29211397/efficacy-of-targeted-therapy-for-advanced-renal-cell-carcinoma-a-systematic-review-and-meta-analysis-of-randomized-controlled-trials
#17
Chao Wei, Shen Wang, Zhangqun Ye, Zhiqiang Chen
We conducted a systematic review and meta-analysis of the literature on the efficacy of the targeted therapies in the treatment of advanced RCC and, via an indirect comparison, to provide an optimal treatment among these agents. A systematic search of Medline, Scopus, Cochrane Library and Clinical Trials unpublished was performed up to Jan 1, 2015 to identify eligible randomized trials. Outcomes of interest assessing a targeted agent included progression free survival (PFS), overall survival (OS) and objective response rate (ORR)...
December 7, 2017: International Braz J Urol: Official Journal of the Brazilian Society of Urology
https://www.readbyqxmd.com/read/29210953/acute-effect-of-citrulline-malate-supplementation-on-upper-body-resistance-exercise-performance-in-recreationally-resistance-trained-men
#18
Adam M Gonzalez, Robert W Spitz, Jamie J Ghigiarelli, Katie M Sell, Gerald T Mangine
To investigate the effect of citrulline malate (CM) supplementation on upper-body resistance exercise performance, twelve recreationally resistance-trained men (21.4±1.6 y; 163.0±46.2 cm; 85.0±12.4 kg) underwent two testing sessions administered in a randomized, double-blind fashion. During each visit, participants were provided either 8 g of CM or a placebo (PL) 40 min prior to beginning a standardized warm-up and initiating a barbell bench press resistance exercise protocol consisting of 5 sets of 15 repetitions at 75% 1RM with 2-minute rest intervals...
November 27, 2017: Journal of Strength and Conditioning Research
https://www.readbyqxmd.com/read/29209510/milrinone-in-congenital-diaphragmatic-hernia-a-randomized-pilot-trial-study-protocol-review-of-literature-and-survey-of-current-practices
#19
REVIEW
Satyan Lakshminrusimha, Martin Keszler, Haresh Kirpalani, Krisa Van Meurs, Patricia Chess, Namasivayam Ambalavanan, Bradley Yoder, Maria V Fraga, Holly Hedrick, Kevin P Lally, Leif Nelin, Michael Cotten, Jonathan Klein, Stephanie Guilford, Ashley Williams, Aasma Chaudhary, Marie Gantz, Jenna Gabrio, Dhuly Chowdhury, Kristin Zaterka-Baxter, Abhik Das, Rosemary D Higgins
Background: Congenital diaphragmatic hernia (CDH) is commonly associated with pulmonary hypoplasia and pulmonary hypertension (PH). PH associated with CDH (CDH-PH) is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO) possibly due to right and left ventricular dysfunction. Milrinone is an intravenous inotrope and lusitrope with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PH. We developed this pilot study to determine if milrinone infusion would improve oxygenation in neonates ≥36 weeks postmenstrual age (PMA) with CDH...
2017: Maternal Health, Neonatology and Perinatology
https://www.readbyqxmd.com/read/29209404/response-to-discrepancies-in-publications-related-to-hmb-fa-and-atp-supplementation
#20
Jacob M Wilson
Gentles and Phillips have submitted questions regarding three recent papers investigating ATP, HMB and the combination. The questions pertaining to the homogeneity of subjects' characteristics between the three different published papers, and why there appears to be differences in the number of subjects in placebo groups across studies. This response addresses each of these issues and demonstrates that there are no discrepancies between papers but rather a misunderstanding of the papers previously published...
2017: Nutrition & Metabolism
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