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https://www.readbyqxmd.com/read/28092306/tripeptide-k-d-pt-is-well-tolerated-in-mild-to-moderate-ulcerative-colitis-results-from-a-randomized-multicenter-study
#1
Torsten Kucharzik, Gunter Lemmnitz, Christoph Abels, Christian Maaser
BACKGROUND: K(D)PT showed marked anti-inflammatory properties in preclinical studies and exhibited very low toxicity in phase I and preclinical trials. In this study, efficacy and safety of oral K(D)PT were evaluated in patients with mild-to-moderate active ulcerative colitis. METHODS: A multicenter, randomized, double-blind, phase IIa trial was performed comparing add-on oral K(D)PT twice a day (20, 50, or 100 mg) with placebo in patients with mild-to-moderate active ulcerative colitis on baseline medication...
January 12, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28092056/a-randomised-placebo-controlled-crossover-study-investigating-the-effects-of-nicotine-gum-on-strength-power-and-anaerobic-performance-in-nicotine-na%C3%A3-ve-active-males
#2
Toby Mündel, Marine Machal, Darryl J Cochrane, Matthew J Barnes
BACKGROUND: Nicotine use amongst athletes is high and increasing, especially team sports, yet the limited previous studies investigating the performance consequences of this behaviour have not examined the effects of the principal active ingredient, nicotine, per se. Therefore, we determined whether nicotine gum affected muscular and anaerobic performance. METHODS: Nine active males (24 ± 3 years) completed three trials in a random order in which 20 min prior to testing they chewed 2 mg (NIC-2), 4 mg (NIC-4) nicotine or flavour-matched placebo (PLA) gum...
December 2017: Sports Medicine—Open
https://www.readbyqxmd.com/read/28091532/development-of-the-neuroimmune-modulator-ibudilast-for-the-treatment-of-alcoholism-a-randomized-placebo-controlled-human-laboratory-trial
#3
Lara A Ray, Spencer Bujarski, Steve Shoptaw, Daniel Jo Roche, Keith Heinzerling, Karen Miotto
Current directions in medication development for alcohol use disorder (AUD) emphasize the need to identify novel molecular targets and efficiently screen new compounds aimed at those targets. Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor and was recently found to reduce alcohol intake in rats by approximately 50%. To advance medications development for AUD, the present study consists of a randomized, crossover, double-blind, placebo-controlled laboratory study of IBUD in non-treatment seeking individuals with current (ie, past month) mild-to-severe AUD...
January 16, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28091362/epicutaneous-immunotherapy-for-the-treatment-of-peanut-allergy-in-children-and-young-adults
#4
Stacie M Jones, Scott H Sicherer, A Wesley Burks, Donald Y M Leung, Robert W Lindblad, Peter Dawson, Alice K Henning, M Cecilia Berin, David Chiang, Brian P Vickery, Robbie D Pesek, Christine B Cho, Wendy F Davidson, Marshall Plaut, Hugh A Sampson, Robert A Wood
BACKGROUND: Peanut allergy is common, life-threatening, and without therapeutic options. We evaluated peanut epicutaneous immunotherapy (EPIT) by using Viaskin Peanut for peanut allergy treatment. OBJECTIVE: We sought to evaluate the clinical, safety, and immunologic effects of EPIT for the treatment of peanut allergy. METHODS: In this multicenter, double-blind, randomized, placebo-controlled study, 74 participants with peanut allergy (ages 4-25 years) were treated with placebo (n = 25), Viaskin Peanut 100 μg (VP100; n = 24) or Viaskin Peanut 250 μg (VP250; n = 25; DBV Technologies, Montrouge, France)...
October 20, 2016: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28091349/intranasal-oxytocin-increases-facial-expressivity-but-not-ratings-of-trustworthiness-in-patients-with-schizophrenia-and-healthy-controls
#5
J D Woolley, B Chuang, C Fussell, S Scherer, B Biagianti, D Fulford, D H Mathalon, S Vinogradov
BACKGROUND: Blunted facial affect is a common negative symptom of schizophrenia. Additionally, assessing the trustworthiness of faces is a social cognitive ability that is impaired in schizophrenia. Currently available pharmacological agents are ineffective at improving either of these symptoms, despite their clinical significance. The hypothalamic neuropeptide oxytocin has multiple prosocial effects when administered intranasally to healthy individuals and shows promise in decreasing negative symptoms and enhancing social cognition in schizophrenia...
January 16, 2017: Psychological Medicine
https://www.readbyqxmd.com/read/28090679/effect-of-prucalopride-on-intestinal-gas-tolerance-in-patients-with-functional-bowel-disorders-and-constipation
#6
Carolina Malagelada, Adoración Nieto, Sara Mendez, Anna Accarino, Javier Santos, Juan-R Malagelada, Fernando Azpiroz
BACKGROUND: Patients with functional bowel disorders develop gas retention and symptoms in response to intestinal gas loads that are well tolerated by healthy subjects. Stimulation of 5HT-4 receptors in the gut has both prokinetic and antinociceptive effects. AIM: To determine the effect of prucalopride, a highly selective 5HT-4 agonist, on gas transit and tolerance in women with functional bowel disorders complaining of constipation. METHODS: Twenty-four women with functional bowel disorders complaining of constipation were included in the study...
January 15, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28090293/relevance-of-angiopoietin-2-and-soluble-p-selectin-levels-in-patients-with-pulmonary-arterial-hypertension-receiving-combination-therapy-with-oral-treprostinil-a-freedom-c2-biomarker-substudy
#7
Manuel J Richter, Ralph Schermuly, Werner Seeger, Youlan Rao, Hossein A Ghofrani, Henning Gall
: Studies have suggested roles for angiopoietin-2 (Ang-2) and soluble P-selectin (sP-selectin) as biomarkers of disease severity and treatment response in pulmonary arterial hypertension (PAH), but additional data are required for validation. We evaluated these biomarkers using data from FREEDOM-C2, in which patients with PAH receiving stable monotherapy or combination therapy were randomized to receive additional treatment with oral treprostinil (up-titrated from 0.25 mg twice daily) or placebo for 16 weeks...
December 2016: Pulmonary Circulation
https://www.readbyqxmd.com/read/28090180/a-randomised-placebo-controlled-trial-of-neurodynamic-sliders-on-hamstring-responses-in-footballers-with-hamstring-tightness
#8
Pattanasin Areeudomwong, Ketsarakon Oatyimprai, Saranchana Pathumb
BACKGROUND: Neurodynamics intervention is known to increase apparent muscle extensibility, but information regarding hamstring responses after a neurodynamic sliders (NS) technique is scarce. The aim of this study was to evaluate the effects of NS on apparent hamstring extensibility and activity in footballers with hamstring tightness. METHODS: Forty eligible healthy male footballers with hamstring tightness were each randomly allocated to either a 4-week NS technique or a control group (CG) receiving placebo shortwave intervention...
November 2016: Malaysian Journal of Medical Sciences: MJMS
https://www.readbyqxmd.com/read/28089730/chronic-prostate-inflammation-predicts-symptom-progression-in-chronic-prostatitis-chronic-pelvic-pain-cp-cpps-patients
#9
J Curtis Nickel, Stephen J Freedland, Ramiro Castro-Santamaria, Daniel M Moreira
OBJECTIVE: This report examines the 4-year longitudinal association between histological prostate inflammation and CP/CPPS, development of new and progression of existing CP/CPPS, in the men randomized to placebo in the REDUCE population. METHODS: Uni- and multivariable analyses at multiple time points over 4 years were performed between acute and chronic inflammation detected on baseline biopsies and incidence of CPPS-like symptoms (defined as a positive response to CPSI question 1a [perineal pain] and/or question 2b [ejaculatory pain], and a total pain subscore of at least 4) and progression of CP/CPPS (defined as an increase ≥ 4 points from baseline total CPSI score in patients with a baseline categorization of CP/CPPS)...
January 12, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28089606/parasacral-transcutaneous-electrical-neural-stimulation-ptens-once-a-week-for-the-treatment-of-overactive-bladder-in-children-a-randomized-controlled-trial
#10
Lidyanne Ilidia da Silva de Paula, Liliana Fajardo de Oliveira, Brysa Paiva Cruz, Dayana Maria de Oliveira, Laís Maini Miranda, Mauro de Moraes Ribeiro, Raphaela Ornellas Duque, André Avarese de Figueiredo, José de Bessa, José Murillo Bastos Netto
INTRODUCTION: Overactive bladder (OAB) is the most prevalent voiding disorder in childhood, and its main manifestation is urinary urgency. In general, urotherapy and anticholinergics are the first choices of treatment. Parasacral Transcutaneous Electrical Neural Stimulation (PTENS) was introduced as an alternative for the treatment of detrusor overactivity in children, but treatment protocols described to date require several sessions per week or long-lasting sessions, making it difficult for the child to adhere to the treatment...
December 21, 2016: Journal of Pediatric Urology
https://www.readbyqxmd.com/read/28089577/neutralizing-anti-interleukin-1%C3%AE-antibodies-reduce-ischemia-related-interleukin-1%C3%AE-transport-across-the-blood-brain-barrier-in-fetal-sheep
#11
Aparna Patra, Xiaodi Chen, Grazyna B Sadowska, Jiyong Zhang, Yow-Pin Lim, James F Padbury, William A Banks, Barbara S Stonestreet
Hypoxic ischemic insults predispose to perinatal brain injury. Pro-inflammatory cytokines are important in the evolution of this injury. Interleukin-1β (IL-1β) is a key mediator of inflammatory responses and elevated IL-1β levels in brain correlate with adverse neurodevelopmental outcomes after brain injury. Impaired blood-brain barrier (BBB) function represents an important component of hypoxic-ischemic brain injury in the fetus. In addition, ischemia-reperfusion increases cytokine transport across the BBB of the ovine fetus...
January 9, 2017: Neuroscience
https://www.readbyqxmd.com/read/28088231/efficacy-of-gabapentin-for-prevention-of-postherpetic-neuralgia-study-protocol-for-a-randomized-controlled-clinical-trial
#12
Manuel Rullán, Oana Bulilete, Alfonso Leiva, Aina Soler, Antonia Roca, María José González-Bals, Patricia Lorente, Joan Llobera
BACKGROUND: Postherpetic neuralgia (PHN) is a chronic neuropathic pain that results from alterations of the peripheral nervous system in areas affected by the herpes zoster virus. The symptoms include pain, paresthesia, dysesthesia, hyperalgesia, and allodynia. Despite the availability of pharmacological treatments to control these symptoms, no treatments are available to control the underlying pathophysiology responsible for this disabling condition. METHODS/DESIGN: Patients with herpes zoster who are at least 50 years old and have a pain score of 4 or higher on a visual analogue scale (VAS) will be recruited...
January 14, 2017: Trials
https://www.readbyqxmd.com/read/28087506/a-randomised-phase-ii-study-evaluating-the-efficacy-and-safety-of-subcutaneously-administered-ustekinumab-and-guselkumab-in-patients-with-active-rheumatoid-arthritis-despite-treatment-with-methotrexate
#13
Josef S Smolen, Sandeep K Agarwal, Elena Ilivanova, Xie Lillian Xu, Ye Miao, Yanli Zhuang, Ivo Nnane, Waldemar Radziszewski, Andrew Greenspan, Anna Beutler, Daniel Baker
OBJECTIVE: Interleukin (IL)-12 and IL-23 have been implicated in the pathogenesis of rheumatoid arthritis (RA). The safety and efficacy of ustekinumab, a human monoclonal anti-IL-12/23 p40 antibody, and guselkumab, a human monoclonal anti-IL-23 antibody, were evaluated in adults with active RA despite methotrexate (MTX) therapy. METHODS: Patients were randomly assigned (1:1:1:1:1) to receive placebo at weeks 0, 4 and every 8 weeks (n=55), ustekinumab 90 mg at weeks 0, 4 and every 8 weeks (n=55), ustekinumab 90 mg at weeks 0, 4 and every 12 weeks (n=55), guselkumab 50 mg at weeks 0, 4 and every 8 weeks (n=55), or guselkumab 200 mg at weeks 0, 4 and every 8 weeks (n=54) through week 28; all patients continued a stable dose of MTX (10-25 mg/week)...
January 13, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28087133/secukinumab-sustains-early-patient-reported-outcome-benefits-through-1%C3%A2-year-results-from-2-phase-iii-randomized-placebo-controlled-clinical-trials-comparing-secukinumab-with-etanercept
#14
Bruce Strober, Alice B Gottlieb, Bintu Sherif, Patrick Mollon, Isabelle Gilloteau, Lori McLeod, Todd Fox, Margaret Mordin, Ari Gnanasakthy, Charis Papavassilis, Mark G Lebwohl
BACKGROUND: Psoriasis is a chronic condition with negative impact on patients' quality of life that most often requires lifelong effective and safe treatment. OBJECTIVE: This analysis focused on the effect of secukinumab treatment on patient-reported health-related quality of life as assessed by the Dermatology Life Quality Index (DLQI) in patients with moderate to severe psoriasis. METHODS: The proportion of subjects achieving DLQI score 0/1 response at week 24, time to DLQI score 0/1 response, and sustained DLQI score 0/1 response up to week 52 were compared between secukinumab and etanercept...
January 10, 2017: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/28087128/intranasal-oxytocin-to-prevent-posttraumatic-stress-disorder-symptoms-a-randomized-controlled-trial-in-emergency-department-patients
#15
Mirjam van Zuiden, Jessie L Frijling, Laura Nawijn, Saskia B J Koch, J Carel Goslings, Jan S Luitse, Tessa H Biesheuvel, Adriaan Honig, Dick J Veltman, Miranda Olff
BACKGROUND: There are currently few preventive interventions available for posttraumatic stress disorder (PTSD). Intranasal oxytocin administration early after trauma may prevent PTSD, because oxytocin administration was previously found to beneficially impact PTSD vulnerability factors, including neural fear responsiveness, peripheral stress reactivity, and socioemotional functioning. Therefore, we investigated the effects of intranasal oxytocin administration early after trauma on subsequent clinician-rated PTSD symptoms...
December 8, 2016: Biological Psychiatry
https://www.readbyqxmd.com/read/28087069/safety-tolerability-and-antiviral-effect-of-rg-101-in-patients-with-chronic-hepatitis-c-a-phase-1b-double-blind-randomised-controlled-trial
#16
Meike H van der Ree, J Marleen de Vree, Femke Stelma, Sophie Willemse, Marc van der Valk, Svend Rietdijk, Richard Molenkamp, Janke Schinkel, Ad C van Nuenen, Ulrich Beuers, Salah Hadi, Marten Harbers, Eva van der Veer, Kai Liu, John Grundy, Amy K Patick, Adam Pavlicek, Jacqueline Blem, Michael Huang, Paul Grint, Steven Neben, Neil W Gibson, Neeltje A Kootstra, Hendrik W Reesink
BACKGROUND: miR-122 is an important host factor for hepatitis C virus (HCV) replication. The aim of this study was to assess the safety and tolerability, pharmacokinetics, and antiviral effect of a single dose of RG-101, a hepatocyte targeted N-acetylgalactosamine conjugated oligonucleotide that antagonises miR-122, in patients with chronic HCV infection with various genotypes. METHODS: In this randomised, double-blind, placebo-controlled, multicentre, phase 1B study, patients were randomly assigned to RG-101 or placebo (7:1)...
January 10, 2017: Lancet
https://www.readbyqxmd.com/read/28079500/efficacy-and-safety-of-tofacitinib-in-older-and-younger-patients-with-rheumatoid-arthritis
#17
Jeffrey R Curtis, Hendrik Schulze-Koops, Liza Takiya, Charles A Mebus, Ketti K Terry, Pinaki Biswas, Thomas V Jones
OBJECTIVES: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). We evaluated the efficacy and safety of tofacitinib 5 or 10 mg twice daily (BID), in patients with moderate to severe RA, aged ≥65 and <65 years. METHODS: Data were pooled from five Phase 3 trials and, separately, from two open-label long-term extension (LTE) studies (data cut-off April, 2012). Patients received tofacitinib, or placebo (Phase 3 only), with/without conventional synthetic DMARDs (mainly methotrexate)...
January 4, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28079166/oxytocin-biases-men-but-not-women-to-restore-social-connections-with-individuals-who-socially-exclude-them
#18
Xiaolei Xu, Shuxia Yao, Lei Xu, Yayuan Geng, Weihua Zhao, Xiaole Ma, Juan Kou, Ruixue Luo, Keith M Kendrick
We normally react to individuals who exclude us socially by either avoiding them or increasing our attempts to interact with them. The neuropeptide oxytocin can promote social bonds and reduce social conflict and we therefore investigated whether it facilitates more positive social responses towards individuals who exclude or include us. In a double-blind, placebo-controlled, between-subject design 77 healthy Chinese male and female participants received intranasal oxytocin (40 IU) or placebo before playing a modified virtual ball-tossing game with three fictitious partners who either showed exclusion, inclusion or neutral behavioral interactions with them...
January 12, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28077588/first-in-human-evaluation-of-the-safety-and-immunogenicity-of-an-intranasally-administered-replication-competent-sendai-virus-vectored-hiv-type-1-gag-vaccine-induction-of-potent-t-cell-or-antibody-responses-in-prime-boost-regimens
#19
Julien Nyombayire, Omu Anzala, Brian Gazzard, Etienne Karita, Philip Bergin, Peter Hayes, Jakub Kopycinski, Gloria Omosa-Manyonyi, Akil Jackson, Jean Bizimana, Bashir Farah, Eddy Sayeed, Christopher L Parks, Makoto Inoue, Takashi Hironaka, Hiroto Hara, Tsugumine Shu, Tetsuro Matano, Len Dally, Burc Barin, Harriet Park, Jill Gilmour, Angela Lombardo, Jean-Louis Excler, Patricia Fast, Dagna S Laufer, Josephine H Cox
BACKGROUND:  We report the first-in-human safety and immunogenicity assessment of a prototype intranasally administered, replication-competent Sendai virus (SeV)-vectored, human immunodeficiency virus type 1 (HIV-1) vaccine. METHODS:  Sixty-five HIV-1-uninfected adults in Kenya, Rwanda, and the United Kingdom were assigned to receive 1 of 4 prime-boost regimens (administered at 0 and 4 months, respectively; ratio of vaccine to placebo recipients, 12:4): priming with a lower-dose SeV-Gag given intranasally, followed by boosting with an adenovirus 35-vectored vaccine encoding HIV-1 Gag, reverse transcriptase, integrase, and Nef (Ad35-GRIN) given intramuscularly (SLA); priming with a higher-dose SeV-Gag given intranasally, followed by boosting with Ad35-GRIN given intramuscularly (SHA); priming with Ad35-GRIN given intramuscularly, followed by boosting with a higher-dose SeV-Gag given intranasally (ASH); and priming and boosting with a higher-dose SeV-Gag given intranasally (SHSH)...
January 1, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28076331/a-short-term-intervention-with-selenium-affects-expression-of-genes-implicated-in-the-epithelial-to-mesenchymal-transition-in-the-prostate
#20
Dieuwertje E G Kok, Lambertus A L M Kiemeney, Gerald W Verhaegh, Jack A Schalken, Emile N J T van Lin, J P Michiel Sedelaar, J Alfred Witjes, Christina A Hulsbergen-van de Kaa, Pieter Van't Veer, Ellen Kampman, Lydia A Afman
In parallel with the inconsistency in observational studies and chemoprevention trials, the mechanisms by which selenium affects prostate cancer risk have not been elucidated. We conducted a randomized, placebo-controlled trial to examine the effects of a short-term intervention with selenium on gene expression in non-malignant prostate tissue. Twenty-three men received 300 µg selenium per day in the form of selenized yeast (n=12) or a placebo (n=11) during 5 weeks. Prostate biopsies collected from the transition zone before and after intervention were analysed for 15 participants (n=8 selenium, n=7 placebo)...
January 6, 2017: Oncotarget
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