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https://www.readbyqxmd.com/read/28817744/predictors-of-corneal-perforation-or-need-for-therapeutic-keratoplasty-in-severe-fungal-keratitis-a-secondary-analysis-of-the-mycotic-ulcer-treatment-trial-ii
#1
N Venkatesh Prajna, Tiruvengada Krishnan, Revathi Rajaraman, Sushila Patel, Ranjeet Shah, Muthiah Srinivasan, Manoranjan Das, Kathryn J Ray, Catherine E Oldenburg, Stephen D McLeod, Michael E Zegans, Nisha R Acharya, Thomas M Lietman, Jennifer Rose-Nussbaumer
Importance: Identifying patients with infectious keratitis who are at risk of experiencing a poor outcome may be useful to allocate resources toward high- risk patients, particularly in resource-poor settings. Objective: To determine baseline patient and ulcer characteristics that predict a high risk of developing corneal perforation and/or the need to undergo therapeutic penetrating keratoplasty (TPK). Design, Setting, and Participants: This is a secondary analysis of Mycotic Ulcer Treatment Trial II, a multicenter, double-masked, placebo-controlled randomized clinical trial that enrolled 240 patients with smear-positive filamentous fungal corneal ulcers who enrolled between May 2010 and August 2015...
August 17, 2017: JAMA Ophthalmology
https://www.readbyqxmd.com/read/28817507/comparison-of-consent-models-in-a-randomized-trial-of-corticosteroids-in-pediatric-septic-shock
#2
Kusum Menon, Katharine O'Hearn, James Dayre McNally, Anand Acharya, Hector R Wong, Margaret Lawson, Tim Ramsay, Lauralyn McIntyre, Elaine Gilfoyle, Marisa Tucci, David Wensley, Ronald Gottesman, Gavin Morrison, Karen Choong
OBJECTIVES: To describe the use of deferred and prior informed consent models in the context of a low additional risk to standard of care, placebo-controlled randomized controlled trial of corticosteroids in pediatric septic shock. DESIGN: An observational substudy of consent processes in a randomized controlled trial of hydrocortisone versus placebo. SETTING: Seven tertiary level PICUs in Canada. PATIENTS: Children newborn to 17 years inclusive admitted to PICU with suspected septic shock between July 2014 and March 2016...
August 16, 2017: Pediatric Critical Care Medicine
https://www.readbyqxmd.com/read/28817491/speed-of-improvement-in-symptoms-of-depression-with-desvenlafaxine-50-mg-and-100-mg-compared-with-placebo-in-patients-with-major-depressive-disorder
#3
Martin A Katzman, Andrew A Nierenberg, Dalia B Wajsbrot, Ellen Meier, Rita Prieto, Elizabeth Pappadopulos, Joan Mackell, Matthieu Boucher
PURPOSE/BACKGROUND: This post hoc analysis examined the time point at which clinically significant improvement in major depressive disorder (MDD) symptoms occurs with desvenlafaxine versus placebo. METHODS: Data were pooled from 9 short-term, double-blind, placebo-controlled studies in adults with MDD randomly assigned to desvenlafaxine 50 mg/d, 100 mg/d, or placebo. A mixed-effects model for repeated-measures analysis of change from baseline score was used to determine the time point at which desvenlafaxine treatment groups separated from placebo on the 17-item Hamilton Rating Scale for Depression and psychosocial outcomes...
August 16, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28817365/effect-of-flibanserin-treatment-on-body-weight-in-premenopausal-and-postmenopausal-women-with-hypoactive-sexual-desire-disorder-a-post-hoc-analysis
#4
Susan G Kornstein, James A Simon, Stuart C Apfel, James Yuan, Krista A Barbour, Robert Kissling
BACKGROUND: Flibanserin, a 5-HT1A agonist and 5-HT2A antagonist, is indicated for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. This post hoc analysis evaluated the effect of flibanserin treatment on body weight in premenopausal and postmenopausal women with HSDD. MATERIALS AND METHODS: This analysis included three 24-week, double-blind, placebo-controlled studies of flibanserin 100 mg each bedtime (qhs) in premenopausal women, a similarly designed study in postmenopausal women, and a 52-week, open-label extension study in premenopausal women...
August 17, 2017: Journal of Women's Health
https://www.readbyqxmd.com/read/28817201/exposure-response-modeling-and-power-analysis-of-components-of-acr-response-criteria-in-rheumatoid-arthritis-part-2-continuous-model
#5
Liang Li, Yi Zhang, Lian Ma, Ping Ji, Sarah Yim, Badrul A Chowdhury, Suresh Doddapaneni, Jiang Liu, Yaning Wang, Chandrahas Sahajwalla
Population pharmacokinetic/pharmacodynamic (PK/PD) models were developed to quantitate the exposure-response relationships using continuous longitudinal data on American College of Rheumatology (ACR) subcomponents, that is, tender-joint count (TJC), swollen-joint count (SJC), C-reactive protein, patient's assessment of pain, patient's global assessment of disease activity, physician's global assessment of disease activity, and patient's assessment of physical function for 5 biologics approved for use in rheumatoid arthritis...
September 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28817199/exposure-response-modeling-and-power-analysis-of-components-of-acr-response-criteria-in-rheumatoid-arthritis-part-1-binary-model
#6
Liang Li, Yi Zhang, Lian Ma, Ping Ji, Sarah Yim, Badrul Chowdhury, Suresh Doddapaneni, Jiang Liu, Yaning Wang, Chandrahas Sahajwalla
American College of Rheumatology (ACR) response criteria is used to assess improvement in tender and swollen joint counts and in 3 of the 5 core measures (acute-phase reactant, physician global assessment, patient global assessment, pain, and physical function). From the clinical trial data on 5 approved biological products for the treatment of rheumatoid arthritis, population pharmacokinetic/pharmacodynamic models were developed to quantitatively describe the relationship between exposure and response rates of 3 individual components of ACR response criteria...
September 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28816944/acute-changes-in-neuromuscular-activity-in-vertical-jump-and-flexibility-after-exposure-to-whole-body-vibration
#7
Giuseppe Annino, Ferdinando Iellamo, Francesco Palazzo, Augusto Fusco, Mauro Lombardo, Francesca Campoli, Elvira Padua
This study was aimed to investigate the neuromuscular activity after 10 minutes of exposure to a whole body vibration (WBV) session.Twenty male young adults (24.8 ± 2.5 year olds) were randomized and divided into 2 groups: the vibration group (VG) was exposed to 10 minutes of WBV at 35 Hz; performed 10 minutes of WBV at 35 Hz (displacement = 5 mm; magnitude = 5 g); the nonvibrated group (NVG) was the placebo group that maintained the same position on the plate but without exposure to any type of vibration...
August 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28816930/associations-among-circulating-csf-1-estrogen-and-bone-mineral-density-in-postmenopausal-women-results-from-a-randomized-placebo-controlled-trial
#8
Andrea V Haas, Elaine Cong, Christine A Simpson, Nitin Sukumar, Yanhong Deng, Karl L Insogna
OBJECTIVE: This study addresses the relationship between circulating levels of colony-stimulating factor 1 (CSF-1) and rates of postmenopausal bone loss. The purpose was to test the hypothesis that CSF-1 levels would correlate with the rate of bone loss in estrogen-deficient woman. We further hypothesized that estrogen replacement would eliminate this association. METHODS: This was an ancillary study to the parent Kronos Early Estrogen Prevention Study (KEEPS)-a 4-year randomized placebo-controlled study that evaluated the effects of estrogen therapy on cardiovascular endpoints...
August 14, 2017: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/28816924/treatment-of-premenstrual-breakthrough-of-depression-with-adjunctive-oral-contraceptive-pills-compared-with-placebo
#9
Whitney Peters, Marlene P Freeman, Semmie Kim, Lee S Cohen, Hadine Joffe
PURPOSE/BACKGROUND: Two-thirds of women with depressive disorders report reemergence of depression premenstrually, or premenstrual exacerbation (PME), despite effective treatment of the underlying mood disorder during the remainder of the cycle. There is a paucity of studies that rigorously assess treatments targeting PME. Open-label data suggest that augmentation of antidepressants with the oral contraceptive pill (OCP) drospirenone and ethinyl estradiol (DRSP/EE) improves depressive symptoms that break through treatment premenstrually...
August 15, 2017: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28816922/nil-whey-protein-effect-on-glycaemic-control-after-intense-mixed-mode-training-in-t2d
#10
Kim A Gaffney, Adam Lucero, Lee Stoner, James Faulkner, Patricia Whitfield, Jeremy Krebs, David S Rowlands
While intense endurance and resistance exercise training and whey protein supplementation have both been shown to independently improve glycaemic control, no known studies have examined the effect of high-intensity mixed-mode interval training (MMIT) and whey supplementation in adults with Type-2 diabetes (T2D). PURPOSE: To determine if peri-training whey protein supplementation combined with MMIT can improve glycaemic control. METHODS: In a double-blind randomised controlled trial, 24 men (55...
August 14, 2017: Medicine and Science in Sports and Exercise
https://www.readbyqxmd.com/read/28816509/shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-children-and-adolescents-results-of-a-randomized-double-blind-placebo-controlled-study
#11
Matthew Brams, Ann C Childress, Michael Greenbaum, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The aim of this study was to evaluate the efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS: This randomized, double-blind dose-optimization study enrolled children and adolescents (6-17 years) meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision ADHD criteria and having baseline ADHD Rating Scale IV (ADHD-RS-IV) total scores ≥28...
August 17, 2017: Journal of Child and Adolescent Psychopharmacology
https://www.readbyqxmd.com/read/28816346/homocysteine-lowering-interventions-for-preventing-cardiovascular-events
#12
REVIEW
Arturo J Martí-Carvajal, Ivan Solà, Dimitrios Lathyris, Mark Dayer
BACKGROUND: Cardiovascular disease, which includes coronary artery disease, stroke and peripheral vascular disease, is a leading cause of death worldwide. Homocysteine is an amino acid with biological functions in methionine metabolism. A postulated risk factor for cardiovascular disease is an elevated circulating total homocysteine level. The impact of homocysteine-lowering interventions, given to patients in the form of vitamins B6, B9 or B12 supplements, on cardiovascular events has been investigated...
August 17, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28816293/-effects-of-bioactive-glass-on-reducing-the-hypersensitivity-after-full-crown-preparation
#13
H Li, Y H Liu, Z Q Luo
OBJECTIVE: To evaluate the efficacy of the 45S5 bioactive glass on the reduction of hypersensitivity of teeth prepared for full coverage crowns. METHODS: In the study, 31 prepared abutment teeth with vital pulp from 18 patients satisfied the inclusion criteria and exclusion criteria. The patients were informed consent and recruited into the study. This was a before and after self-control, single blind clinical trial. The severity of tooth hypersensitivity at baseline was evaluated, after application of the placebo, which was the powder of zinc oxide, and after application of the 45S5 bioactive glass on the same tooth...
August 18, 2017: Beijing da Xue Xue Bao. Yi Xue Ban, Journal of Peking University. Health Sciences
https://www.readbyqxmd.com/read/28816243/dopamine-synthesis-capacity-is-associated-with-d2-3-receptor-binding-but-not-dopamine-release
#14
Anne S Berry, Vyoma D Shah, Daniella J Furman, Robert L White, Suzanne L Baker, James P O'Neil, Mustafa Janabi, Mark D'Esposito, William J Jagust
Positron Emission Tomography (PET) imaging allows the estimation of multiple aspects of dopamine function including dopamine synthesis capacity, dopamine release, and D2/3 receptor binding. Though dopaminergic dysregulation characterizes a number of neuropsychiatric disorders including schizophrenia and addiction, there has been relatively little investigation into the nature of relationships across dopamine markers within healthy individuals. Here we used PET imaging in 40 healthy adults to compare, within individuals, estimates of dopamine synthesis capacity (Ki) using 6-[(18)F]fluoro-l-m-tyrosine ([(18)F]FMT; a substrate for aromatic amino acid decarboxylase), baseline D2/3 receptor binding potential using [(11)C]raclopride (a weak competitive D2/3 receptor antagonist), and dopamine release using [(11)C]raclopride paired with oral methylphenidate administration...
August 17, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28816242/effect-of-the-mglur5-nam-basimglurant-on-behavior-in-adolescents-and-adults-with-fragile-x-syndrome-in-a-randomized-double-blind-placebo-controlled-trial-fragxis-phase-2-results
#15
Eriene A Youssef, Elizabeth Berry-Kravis, Christian Czech, Randi J Hagerman, David Hessl, Chin Y Wong, Michael Rabbia, Dennis Deptula, Amy John, Russell Kinch, Philip Drewitt, Lothar Lindemann, Moritz Marcinowski, Rachel Langland, Carsten Horn, Paulo Fontoura, Luca Santarelli, Jorge A Quiroz
Preclinical data suggests that inhibition of the mGluR5 receptor might hold therapeutic benefits in Fragile X syndrome (FXS). Treatment of Fmr1 knockout mice with mGluR5-negative allosteric modulators (NAMs) has been reported to correct a broad range of phenotypes related to FXS. The early short-term clinical trials with mGluR5 NAMs, including basimglurant, assessing the effects in individuals with FXS, were supportive of further exploration in larger, well-controlled trials. We evaluated basimglurant, a potent and selective mGluR5 NAM, in a 12-week, double-blind, parallel-group study of 183 adults and adolescents (aged 14-50, mean 23...
August 17, 2017: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
https://www.readbyqxmd.com/read/28815987/health-related-quality-of-life-in-randomized-controlled-trials-of-lorcaserin-for-obesity-management-what-mediates-improvement
#16
R L Kolotkin, R D Crosby, Z Wang
Lorcaserin, plus diet and exercise, has demonstrated significant weight loss and improved cardiometabolic parameters vs. placebo in patients with overweight/obesity in three randomized, placebo-controlled trials. We examined whether lorcaserin is also associated with greater improvements in health-related quality of life (HRQOL) and whether these improvements are wholly attributable to weight loss. Pooled data from Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM), Behavioral Modification and Lorcaserin Second Study for Obesity Management (BLOSSOM) and BLOOM-Diabetes Mellitus (BLOOM-DM) trials were analysed (n = 5624)...
August 17, 2017: Clinical Obesity
https://www.readbyqxmd.com/read/28815639/safety-tolerability-and-pharmacokinetic-characteristics-of%C3%A2-a-novel-nonopioid-analgesic-vvz-149-injections-in-healthy-volunteers-a-first-in-class-first-in-human-study
#17
Jaeseong Oh, SeungHwan Lee, Anhye Kim, Jangsoo Yoon, Kyungho Jang, Doo H Lee, Sunyoung Cho, Sang Rim Lee, Kyung-Sang Yu, Jae-Yong Chung
VVZ-149, a dual antagonist of GlyT2 and 5HT2 A receptors, is an investigational analgesic with a novel mechanism of action that is currently under early-stage clinical development as an injectable agent for the treatment of postoperative pain. Here, the safety, tolerability, and pharmacokinetics of VVZ-149 injections in healthy male volunteers were explored in a randomized, double-blind, single- and multiple-ascending-dose (SAD and MAD, respectively), placebo-controlled clinical study. Subjects randomly received a 4-hour intravenous infusion of 0...
August 16, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28815614/resveratrol-for-alzheimer-s-disease
#18
REVIEW
Christine Sawda, Charbel Moussa, R Scott Turner
The amyloid hypothesis suggests that the progressive accumulation and deposition of central nervous system (CNS) amyloid with aging is the proximate cause of Alzheimer's disease (AD). Thus, targeting molecular mechanisms of aging may be a viable treatment approach. Caloric restriction prevents diseases of aging, including AD, in animal models, perhaps by activation of sirtuins. The sirtuins (e.g., mammalian SIRT1) are deacetylases that link energy balance (NAD(+) /NADH) to regulation of gene transcription. Resveratrol is a potent activator of SIRT1, and thus may mimic caloric restriction to prevent diseases of aging...
August 16, 2017: Annals of the New York Academy of Sciences
https://www.readbyqxmd.com/read/28815430/clinical-evaluation-of-the-antifungal-effect-of-sertraline-in-the-treatment-of-cryptococcal-meningitis-in-hiv-patients-a-single-mexican-center-experience
#19
Hiram Villanueva-Lozano, Rogelio de J Treviño-Rangel, Gloria M González, Pedro A Hernández-Rodríguez, Adrián Camacho-Ortiz, Luis Castillo-Reyna, Sandra G Galindo-Alvarado, Michel F Martínez-Reséndez
PURPOSE: Cryptococcal meningitis is a potentially fatal fungal infection associated with a significant attributable morbidity and mortality, especially among HIV/AIDS patients. The first-line therapy for the treatment of this clinical entity is the combinatory therapy of amphotericin B plus flucytosine. However, the high cost, toxic effects, and limited repertoire of effective antifungal drugs have led to the investigation of novel molecules. This is a prospective, double-blinded, and randomized study performed in a Mexican tertiary care center to evaluate the antifungal activity of sertraline in the treatment of cryptococcal meningitis in HIV patients...
August 16, 2017: Infection
https://www.readbyqxmd.com/read/28815419/effect-of-sertraline-on-complications-and-survival-after-hematopoietic-stem-cell-transplantation-a-double-blind-placebo-controlled-clinical-study
#20
Maria Tavakoli-Ardakani, Raziyeh Kheshti, Mehrpooya Maryam
Previous studies have found a connection between psychiatric problems and post-hematopoietic stem-cell transplantation (HSCT) complications. We sought to evaluate the effect of sertraline on engraftment time, hospitalization period, mortality, and post-transplantation complications in HSCT recipients with depression and/or anxiety. We recruited adults aged 18-60, who were candidates for autologous or allogeneic HSCT with major depression and/or anxiety disorder. They were administered 50 mg of sertraline or placebo daily for the first week, and then 100 mg for the following seven weeks...
August 16, 2017: International Journal of Hematology
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