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https://www.readbyqxmd.com/read/28333187/eldelumab-anti-interferon-%C3%AE-inducible-protein-10-antibody-induction-therapy-for-active-crohn-s-disease-a-randomised-double-blind-placebo-controlled-phase-iia-study
#1
William J Sandborn, Paul Rutgeerts, Jean-Frédéric Colombel, Subrata Ghosh, Robert Petryka, Bruce E Sands, Pranab Mitra, Allison Luo
Background and Aims: This 11-week Phase IIa induction study evaluated the efficacy and safety of eldelumab in patients with active Crohn's disease. Methods: Adults with Crohn's Disease Activity Index 220-450 were randomised 1:1:1 to placebo or eldelumab 10 or 20 mg/kg intravenously on Days 1 and 8, and alternate weeks thereafter. All patients underwent ileocolonoscopy at baseline. Patients with active inflammation according to the Simplified Endoscopic Score for Crohn's Disease criteria [the originally planned endoscopy cohort] underwent another ileocolonoscopy at Week 11 at the investigator's discretion...
February 22, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28331332/clinical-role-of-brexpiprazole-in-depression-and-schizophrenia
#2
REVIEW
Nishant B Parikh, Diana M Robinson, Anita H Clayton
Brexpiprazole, a serotonin-dopamine activity modulator, is the second D2 partial agonist to come to market and has been approved for the treatment of schizophrenia and as an adjunctive treatment in major depressive disorder. With less intrinsic activity than aripiprazole at the D2 receptor and higher potency at 5-HT2A, 5-HT1A, and α1B receptors, the pharmacological properties of brexpiprazole suggest a more tolerable side effect profile with regard to akathisia, extrapyramidal dysfunction, and sedation. While no head-to-head data are currently available, double-blind placebo-controlled studies show favorable results, with the number needed to treat (NNT) vs placebo of 6-15 for response in acute schizophrenia treatment and 4 for maintenance...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28330721/changes-in-the-human-transcriptome-upon-vitamin-d-supplementation
#3
Yvonne Pasing, Christopher Graham Fenton, Rolf Jorde, Ruth Hracky Paulssen
Vitamin D is hydroxylated in the liver and kidneys to its active form, which can bind to the vitamin D receptor (VDR). The VDR is present in a wide variety of different cells types and tissues and acts as a transcription factor. Although activation of the VDR is estimated to regulate expression of up to 5% of the human genome, our study is the first analysing gene expression after supplementation in more than 10 subjects. Subjects of a randomized controlled trial (RCT) received either vitamin D3 (n47) in a weekly dose of 20,000 IU or placebo (n 47) for a period of three to five years...
March 19, 2017: Journal of Steroid Biochemistry and Molecular Biology
https://www.readbyqxmd.com/read/28329211/therapeutic-vaccine-for-genital-herpes-simplex-virus-2-infection-findings-from-a-randomized-trial
#4
David I Bernstein, Anna Wald, Terri Warren, Kenneth Fife, Stephen Tyring, Patricia Lee, Nick Van Wagoner, Amalia Magaret, Jessica B Flechtner, Sybil Tasker, Jason Chan, Amy Morris, Seth Hetherington
Background.: Genital herpes simplex virus type 2 (HSV-2) infection causes recurrent lesions and frequent viral shedding. GEN-003 is a candidate therapeutic vaccine containing HSV-2 gD2ΔTMR and ICP4.2, and Matrix-M2 adjuvant. Methods.: Persons with genital herpes were randomized into three dose cohorts to receive three intramuscular doses 21 days apart of 10 µg, 30 µg, or 100 µg of GEN-003, antigens without adjuvant, or placebo. Participants obtained genital swabs twice-daily for HSV-2 detection and monitored genital lesions for 28-day periods at baseline and intervals after the last dose...
January 30, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28328526/impact-of-a-single-oral-dose-of-100-000-iu-vitamin-d3-on-profiles-of-serum-25-oh-d3-and-its-metabolites-24-25-oh-2d3-3-epi-25-oh-d3-and-1-25-oh-2d3-in-adults-with-vitamin-d-insufficiency
#5
Lanja Saleh, Jonathan Tang, Joanna Gawinecka, Lukas Boesch, William D Fraser, Arnold von Eckardstein, Albina Nowak
BACKGROUND: We investigate the effect of a high dose of vitamin D3 on circulating concentrations of 25(OH)D3 and its metabolites 24,25(OH)2D3, 3-epi-25(OH)D3, and 1,25(OH)2D3 in healthy individuals with self-perceived fatigue and vitamin D insufficiency [25(OH)D3<50 nmol/L]. METHODS: One hundred and seven study participants (age 20-50 years) were randomized to receive a single 100,000 IU dose of vitamin D3 (n=52) or placebo (n=55). Vitamin D metabolite concentrations in serum were measured before, and 4 weeks after, supplementation...
March 22, 2017: Clinical Chemistry and Laboratory Medicine: CCLM
https://www.readbyqxmd.com/read/28328347/prevention-of-hereditary-angioedema-attacks-with-a-subcutaneous-c1-inhibitor
#6
Hilary Longhurst, Marco Cicardi, Timothy Craig, Konrad Bork, Clive Grattan, James Baker, Huamin H Li, Avner Reshef, James Bonner, Jonathan A Bernstein, John Anderson, William R Lumry, Henriette Farkas, Constance H Katelaris, Gordon L Sussman, Joshua Jacobs, Marc Riedl, Michael E Manning, Jacques Hebert, Paul K Keith, Shmuel Kivity, Sergio Neri, Donald S Levy, Maria L Baeza, Robert Nathan, Lawrence B Schwartz, Teresa Caballero, William Yang, Ioana Crisan, María D Hernandez, Iftikhar Hussain, Michael Tarzi, Bruce Ritchie, Pavlina Králíčková, Mar Guilarte, Syed M Rehman, Aleena Banerji, Richard G Gower, Debra Bensen-Kennedy, Jonathan Edelman, Henrike Feuersenger, John-Philip Lawo, Thomas Machnig, Dipti Pawaskar, Ingo Pragst, Bruce L Zuraw
Background Hereditary angioedema is a disabling, potentially fatal condition caused by deficiency (type I) or dysfunction (type II) of the C1 inhibitor protein. In a phase 2 trial, the use of CSL830, a nanofiltered C1 inhibitor preparation that is suitable for subcutaneous injection, resulted in functional levels of C1 inhibitor activity that would be expected to provide effective prophylaxis of attacks. Methods We conducted an international, prospective, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase 3 trial to evaluate the efficacy and safety of self-administered subcutaneous CSL830 in patients with type I or type II hereditary angioedema who had had four or more attacks in a consecutive 2-month period within 3 months before screening...
March 23, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28328346/efficacy-of-a-low-cost-heat-stable-oral-rotavirus-vaccine-in-niger
#7
Sheila Isanaka, Ousmane Guindo, Celine Langendorf, Amadou Matar Seck, Brian D Plikaytis, Nathan Sayinzoga-Makombe, Monica M McNeal, Nicole Meyer, Eric Adehossi, Ali Djibo, Bruno Jochum, Rebecca F Grais
Background Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in sub-Saharan Africa. Methods We conducted a randomized, placebo-controlled trial in Niger to evaluate the efficacy of a live, oral bovine rotavirus pentavalent vaccine (BRV-PV, Serum Institute of India) to prevent severe rotavirus gastroenteritis. Healthy infants received three doses of the vaccine or placebo at 6, 10, and 14 weeks of age...
March 23, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28328159/improved-disease-activity-with-fosdagrocorat-pf-04171327-a-partial-agonist-of-the-glucocorticoid-receptor-in-patients-with-rheumatoid-arthritis-a-phase-2-randomized-study
#8
Thomas Stock, Dona Fleishaker, Xin Wang, Arnab Mukherjee, Charles Mebus
AIM: To assess efficacy and safety of fosdagrocorat (PF-04171327), a potential dissociated agonist of the glucocorticoid receptor, in rheumatoid arthritis (RA) patients. METHODS: This multicenter, double-blind, parallel-group, active- and placebo-controlled Phase 2 study (NCT00938587) randomized 86 patients (1 : 1 : 1 : 1) to receive fosdagrocorat 10 mg, fosdagrocorat 25 mg, prednisone 5 mg or placebo, all with stable background methotrexate therapy. The primary outcome was change from baseline in Disease Activity Score of 28 joints (DAS28-4[C-reactive protein (CRP)]) after 2 weeks of treatment...
March 22, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28327944/a-phase-2-randomized-double-blind-placebo-%C3%A2-controlled-study-of-chemo-immunotherapy-combination-using-motolimod-with-pegylated-liposomal-doxorubicin-in-recurrent-or-persistent-ovarian-cancer-a-gynecologic-oncology-group-partners-study
#9
B J Monk, M F Brady, C Aghajanian, H A Lankes, T Rizack, J Leach, J M Fowler, R Higgins, P Hanjani, M Morgan, R Edwards, W Bradley, T Kolevska, P Foukas, E Swisher, K S Anderson, R Gottardo, J K Bryan, M Newkirk, K L Manjarrez, R S Mannel, R M Hershberg, G Coukos
Background: A phase 2, randomized, placebo-controlled trial was conducted in women with recurrent epithelial ovarian carcinoma to evaluate the efficacy and safety of motolimod-a Toll-like receptor 8 (TLR8) agonist that stimulates robust innate immune responses-combined with pegylated liposomal doxorubicin (PLD), a chemotherapeutic that induces immunogenic cell death. Patients and methods: Women with ovarian, fallopian tube, or primary peritoneal carcinoma were randomized 1 : 1 to receive PLD in combination with blinded motolimod or placebo...
February 21, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28327826/efficacy-of-tacrolimus-for-induction-of-remission-in-patients-with-moderate-to-severe-ulcerative-colitis-a-systematic-review-and-meta-analysis
#10
Juan Lasa, Pablo Olivera
BACKGROUND: There is evidence that shows that calcineurin inhibitors may be useful for the treatment of severe ulcerative colitis. However, evidence regarding the efficacy of tacrolimus for remission induction in this setting is scarce. OBJECTIVE: To develop a systematic review on the existing evidence regarding the clinical efficacy of tacrolimus for the induction of remission in patients with moderate-to-severe ulcerative colitis. METHODS: A literature search was undertaken from 1966 to August 2016 using MEDLINE, Embase, LILACS and the Cochrane Library...
March 16, 2017: Arquivos de Gastroenterologia
https://www.readbyqxmd.com/read/28327453/combining-transcutaneous-electrical-nerve-stimulation-tens-with-oxybutynin-is-superior-to-monotherapy-in-children-with-urge-incontinence-a-randomized-placebo-controlled-study
#11
L Borch, S Hagstroem, K Kamperis, C V Siggaard, S Rittig
PURPOSE: To evaluate if combination therapy with TENS and oxybutynin results in a superior treatment response than monotherapy with the two modalities in childhood urge incontinence. MATERIALS AND METHODS: In this placebo-controlled study 66 urge incontinent children (mean age 7.3 ± 1.6 years) were randomized into three treatment groups. Group 1: active TENS + active oxybutynin (n = 22). Group 2: active TENS + placebo oxybutynin (n = 21). Group 3: active oxybutynin + placebo TENS (n = 23)...
March 18, 2017: Journal of Urology
https://www.readbyqxmd.com/read/28326925/interaction-of-acupuncture-treatment-and-manipulation-laterality-modulated-by-the-default-mode-network
#12
Xuan Niu, Ming Zhang, Zhenyu Liu, Lijun Bai, Chuanzhu Sun, Shan Wang, Xiaocui Wang, Zhen Chen, Hongyan Chen, Jie Tian
Appropriate selection of ipsilateral or contralateral electroacupuncture (corresponding to the pain site) plays an important role in reaching its better curative effect; however, the involving brain mechanism still remains unclear. Compared with the heat pain model generally established in previous study, capsaicin pain model induces reversible cutaneous allodynia and is proved to be better simulating aspects of clinical nociceptive and neuropathic pain. In the current study, 24 subjects were randomly divided into two groups with a 2 × 2 factorial design: laterality (ipsi- or contralateral side, inter-subject) × treatment with counter-balanced at an interval of one week (verum and placebo electroacupuncture, within-subject)...
January 2017: Molecular Pain
https://www.readbyqxmd.com/read/28326568/early-response-predicts-a-sustained-response-to-eluxadoline-in-patients-with-irritable-bowel-syndrome-with-diarrhoea-in-two-phase-3-studies
#13
W D Chey, L S Dove, D A Andrae, P S Covington
BACKGROUND: The mixed μ- and κ-opioid receptor agonist and δ-opioid receptor antagonist, eluxadoline, is licensed in the USA for the treatment of irritable bowel syndrome with diarrhoea (IBS-D), based on the results of two large Phase 3 clinical trials. AIM: To understand the time course of treatment benefits with eluxadoline by comparing responder rates over the first month of treatment with responder rates over longer treatment intervals. METHODS: In this post hoc analysis of two Phase 3 studies, composite and adequate relief (AR) responder rates were calculated over month 1 and patients were stratified by their responder status...
March 22, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28326189/sarilumab-improves-patient-reported-outcomes-in-rheumatoid-arthritis-patients-with-inadequate-response-intolerance-to-tumour-necrosis-factor-inhibitors
#14
Vibeke Strand, Matthew Reaney, Chieh-I Chen, Clare W J Proudfoot, Sophie Guillonneau, Deborah Bauer, Erin Mangan, Neil M H Graham, Hubert van Hoogstraten, Yong Lin, César Pacheco-Tena, Roy Fleischmann
OBJECTIVE: To evaluate effects of the anti-interleukin-6 receptor monoclonal antibody sarilumab administered with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) on patient-reported outcomes (PROs) in the TARGET trial in patients with rheumatoid arthritis (RA) with inadequate response or intolerance to tumour necrosis factor inhibitors (TNF-IR). METHODS: 546 patients (81.9% female, mean age 52.9 years) were randomised to placebo, sarilumab 150 or 200 mg subcutaneously every 2 weeks + csDMARDs...
2017: RMD Open
https://www.readbyqxmd.com/read/28326025/enhancing-effects-of-nmda-receptor-blockade-on-extinction-learning-and-related-brain-activation-are-modulated-by-bmi
#15
Anne Golisch, Stefanie Heba, Benjamin Glaubitz, Martin Tegenthoff, Silke Lissek
A distributed network including prefrontal and hippocampal regions is involved in context-related extinction learning as well as in renewal. Renewal describes the recovery of an extinguished response if the context of extinction differs from the context of recall. Animal studies have demonstrated that prefrontal, but not hippocampal N-methyl-D-aspartate receptor (NMDAR) antagonism disrupted extinction learning and processing of task context. However, human studies of NMDAR in extinction learning are lacking, while NMDAR antagonism yielded contradictory results in other learning tasks...
2017: Frontiers in Behavioral Neuroscience
https://www.readbyqxmd.com/read/28325826/a-phase-ii-randomized-double-blind-presurgical-trial-of-polyphenon-e-in-bladder-cancer-patients-to-evaluate-pharmacodynamics-and-bladder-tissue-biomarkers
#16
Jason R Gee, Daniel R Saltzstein, KyungMann Kim, Jill M Kolesar, Wei Huang, Thomas C Havighurst, Barbara W Wollmer, Jeanne Stublaski, Tracy Downs, Hasan Mukhtar, Margaret House, Howard L Parnes, Howard H Bailey
We performed a phase 2 pharmacodynamic, prevention trial of Polyphenon E® (a green tea polyphenol formulation primarily consisting of epigallocatechin gallate (EGCG)) in patients prior to bladder cancer surgery. Patients with a bladder tumor were randomized to receive Polyphenon E® containing either 800 or 1200 mg of EGCG or placebo for 14 to 28 days prior to TURBT or cystectomy. The primary objective was to compare the post-intervention EGCG tissue levels in patients receiving Polyphenon E® as compared to placebo...
March 21, 2017: Cancer Prevention Research
https://www.readbyqxmd.com/read/28325221/is-metabolic-dysregulation-associated-with-antidepressant-response-in-depressed-women-in-climacteric-treated-with-individualized-homeopathic-medicines-or-fluoxetine-the-homdep-menop-study
#17
Emma Del Carmen Macías-Cortés, Lidia Llanes-González, Leopoldo Aguilar-Faisal, Juan Asbun-Bojalil
BACKGROUND: Climacteric is associated with both depression and metabolic dysregulation. Scarce evidence suggests that metabolic dysregulation may predict poor response to conventional antidepressants. Response to depression treatment has not been studied in homeopathic medicine. The aim of this study was to investigate the prevalence of metabolic disorders in depressed climacteric women treated with homeopathic medicines, fluoxetine or placebo, and if these alterations have any association with response to depression treatment...
February 2017: Homeopathy: the Journal of the Faculty of Homeopathy
https://www.readbyqxmd.com/read/28325123/effect-of-stimulation-of-cold-receptors-with-menthol-on-emg-activity-of-quadriceps-muscle-during-low-load-contraction
#18
Tadayuki Tokunaga, Hitoshi Sugawara, Chigaya Tadano, Masuo Muro
PURPOSE: Facilitatory and inhibitory responses of spinal motor neurons are influenced by somatosensory input from the skin. The purpose of this study, employing electromyography, was to examine the neuromuscular changes that occur with menthol applied to the skin over the quadriceps muscle. METHODS: Forty-two healthy volunteers performed isometric knee extensions at 35% maximum voluntary contraction (MVC) in three groups (Adult Placebo, Adult Menthol, Older Adult Menthol)...
March 21, 2017: Somatosensory & Motor Research
https://www.readbyqxmd.com/read/28324779/frontocingulate-cerebral-blood-flow-and-cerebrovascular-reactivity-associated-with-antidepressant-response-in-late-life-depression
#19
Margarita Abi Zeid Daou, Brian D Boyd, Manus J Donahue, Kimberly Albert, Warren D Taylor
BACKGROUND: Vascular pathology is common in late-life depression (LLD) and may contribute to alterations in cerebral blood flow (CBF) and cerebrovascular reactivity (CVR). In turn, such hemodynamic deficits may adversely affect brain function and clinical course. The goal of this study was to examine whether altered cerebral hemodynamics in depressed elders predicted antidepressant response. METHODS: 21 depressed elders completed cranial 3T MRI, including a pseudo-continuous Arterial Spin Labeling (pcASL) acquisition on both room air and during a hypercapnia challenge...
March 16, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28324705/more-pain-more-gain-blocking-the-opioid-system-boosts-adaptive-cognitive-control
#20
Henk van Steenbergen, Daniel H Weissman, Dan J Stein, Susan Malcolm-Smith, Jack van Honk
The ability to adaptively increase cognitive control in response to cognitive challenges is crucial for goal-directed behavior. Recent findings suggest that aversive arousal triggers adaptive increases of control, but the neurochemical mechanisms underlying these effects remain unclear. Given the known contributions of the opioid system to hedonic states, we investigated whether blocking this system increases adaptive control modulations. To do so, we conducted a double-blind, placebo-controlled psychopharmacological study (n=52 females) involving a Stroop-like task...
March 7, 2017: Psychoneuroendocrinology
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