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Jin Soon Hwang, Hae Sang Lee, Kee-Hyoung Lee, Han-Wook Yoo, Dae-Yeol Lee, Byung-Kyu Suh, Cheol Woo Ko, Woo Yeong Chung, Dong-Kyu Jin, Choong Ho Shin, Heon-Seok Han, Song Han, Ho-Seong Kim
BACKGROUND/AIMS: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). METHODS: This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0...
June 20, 2018: Hormone Research in Pædiatrics
Rocco Maurizio Zagari, Alessandra Romiti, Enzo Ierardi, Antonietta G Gravina, Alba Panarese, Giuseppe Grande, Edoardo Savarino, Giovanni Maconi, Elisa Stasi, Leonardo Henry Eusebi, Fabio Farinati, Rita Conigliaro, Franco Bazzoli, Marco Romano
BACKGROUND: Clinical trials have shown a good efficacy of the "three-in-one" formulation of bismuth quadruple therapy (BQT) for Helicobacter (H.) pylori eradication. We aimed to assess the efficacy and safety of the three-in-one BQT in clinical practice, and investigate the effect of probiotic supplementation, in Italy. MATERIALS AND METHODS: A retrospective database, multicentre observational study was conducted in seven Italian Hospitals. Consecutive H...
June 20, 2018: Helicobacter
Paul E Wischmeyer, Michelle M McMoon, Nathan H Waldron, Elizabeth J Dye
BACKGROUND: Enteral feeding via feeding tube (FT) provides essential nutrition support to critically ill patients or those who cannot intake adequate nutrition via the oral route. Unfortunately, 1%-2% of FTs placed blindly at bedside enter the airway undetected (as confirmed by x-ray), where they could result in adverse events. Misplaced FTs can cause complications including pneumothorax, vocal cord injury, bronchopleural fistula, pneumonia, and death. X-ray is typically performed to confirm FT placement before feeding, but may delay nutrition intake, may not universally identify misplacement, and adds cost and radiation exposure...
June 20, 2018: JPEN. Journal of Parenteral and Enteral Nutrition
Xinke Zhang, Xue Song, Lorena Lopez-Gonzalez, Krutika Jariwala-Parikh, Ze Cong
BACKGROUND: Infections, cytopenia, and gastrointestinal (GI) toxicity are adverse events of special interest (AESI) affecting most relapsed Philadelphia chromosome-negative (Ph-) B-cell acute lymphocytic leukemia (ALL) patients. This study quantified real-world rates and economic burden of these events among relapsed Ph- B-cell ALL patients in the US. RESEARCH DESIGN AND METHODS: Adults with relapsed Ph- B-cell ALL during 4/1/2009 - 10/31/2016 were selected from MarketScan® healthcare claims databases...
June 20, 2018: Expert Review of Pharmacoeconomics & Outcomes Research
Jacqueline S Birks, Richard J Harvey
BACKGROUND: Alzheimer's disease is the most common cause of dementia in older people. One approach to symptomatic treatment of Alzheimer's disease is to enhance cholinergic neurotransmission in the brain by blocking the action of the enzyme responsible for the breakdown of the neurotransmitter acetylcholine. This can be done by a group of drugs known as cholinesterase inhibitors. Donepezil is a cholinesterase inhibitor.This review is an updated version of a review first published in 1998...
June 18, 2018: Cochrane Database of Systematic Reviews
Erika F Augustine, Christopher A Beck, Heather R Adams, Sara Defendorf, Amy Vierhile, Derek Timm, Jill M Weimer, Jonathan W Mink, Frederick J Marshall
Mycophenolate, an immunosuppressant, is commonly used off-label for autoimmune neurological conditions. In CLN3 disease, a neurodegenerative disorder of childhood, preclinical and clinical data suggest secondary autoimmunity and inflammation throughout the central nervous system are key components of pathogenesis. We tested the short-term tolerability of mycophenolate in individuals with CLN3 disease, in preparation for possible long-term efficacy trials of this drug. We conducted a randomized, double-blind, placebo-controlled, crossover study of mycophenolate in 19 ambulatory individuals with CLN3 disease to determine the safety and tolerability of short-term administration (NCT01399047)...
June 20, 2018: JIMD Reports
Natalie Stokes, Jacqueline Kikucki
PURPOSE OF REVIEW: The goal of this review is to elucidate what is known about the science of maternal resuscitation and how treatment guidelines have developed to optimize management. RECENT FINDINGS: There is limited data on maternal cardiac arrest. Case reports are providing some insight into safety and efficacy of certain mechanisms of treatment, including use of extracorporeal membranous oxygenation and thrombolysis, for example. Data increasingly supports the preventability of a significant portion of maternal cardiac arrest, which remains the most important target for intervention...
June 19, 2018: Current Treatment Options in Cardiovascular Medicine
Haozhi Fan, Peng Huang, Ting Tian, Jingjing Wu, Xueshan Xia, Yue Feng, Jie Wang, Rongbin Yu, Yun Zhang, Ming Yue
BACKGROUND AND AIM: Sofosbuvir is a hepatitis C virus (HCV) NS5B polymerase inhibitor. The objective of this study was to explore the efficacy and safety of sofosbuvir for HCV genotype (GT) 2 and 3 infected patients. METHOD: We searched randomized controlled trials (RCTs) which analyzed the efficacy and safety of sofosbuvir-containing regimens for HCV GT 2/3 infected patients and collected data. The endpoints were sustained virological response 12- and 24-weeks after the cessation of therapy (SVR12 and SVR24), the adverse events (AEs) and the severe adverse events (SAEs)...
June 2018: Journal of Gastrointestinal and Liver Diseases: JGLD
Patricia A Walicke, Franz Hefti, Roxanne Bales, Shiao-Ping Lu, Jon L Ruckle, Mark T Brown, Christine R West, David L Shelton
Introduction: The neurotrophin nerve growth factor has a demonstrated role in pain transduction and pathophysiology. Objectives: Two randomized, double-blind, placebo-controlled, phase 1 studies were conducted to evaluate safety, tolerability, and analgesic efficacy of single doses of tanezumab, a humanized anti-nerve growth factor monoclonal antibody, in chronic or acute pain. Methods: In the first study (CL001), patients with moderate to severe pain from osteoarthritis (OA) of the knee received a single intravenous infusion of tanezumab (3-1000 μg/kg) or placebo in a dose-escalation (part 1; N = 42) or parallel-arm (part 2; N = 79) study design...
May 2018: Pain Reports (Baltimore, Md.)
Ibrahim B Salisu, Ahmad A Shahid, Qasim Ali, Abdul Q Rao, Tayyab Husnain
In recent years, the influence of genetically modified (GM) cotton expressing different types of Bt and EPSPS genes has been attested in term of reduced application of pesticides and insecticides coupled with improved cotton production. Although the cultivation of GM cotton has been authorized by the regulatory authorities of various countries in the world, based on the biosafety studies reported by most of the GM cotton producers, yet the information on its safe use are inadequate. In order to support the issues on food safety, it is therefore mandatory to conduct further safety assessment studies on GM cotton for each independent transgenic event on the basis of case assessment rule...
2018: Frontiers in Nutrition
Roberto Amore, Domenico Amuso, Vincenza Leonardi, Andrea Sbarbati, Giamaica Conti, Maria Albini, Francesco Leva, Ferdinando Terranova, Antonio Guida, Konstantinos Gkritzalas, Liya Gavashely, Roman Velichenko
Background: Cellulite can be seen on the skin in widespread alterations of the skin surface and dimpling. The purpose of this study was to assess the effectiveness and safety of the manual subcision technique to treat dimpling from cellulite, using a specific class IIA medical device (Celluerase). Methods: The multi-center observational study assessed 200 women treated in a single session for different dimpling, using manual subcision administered by Celluerase...
May 2018: Plastic and Reconstructive Surgery. Global Open
Thomas P Lillicrap, Christopher R Levi, Elizabeth Holliday, Mark William Parsons, Andrew Bivard
Background: The phase-II modafinil in debilitating fatigue after stroke trial demonstrated that modafinil improves fatigue and quality of life in severely fatigued stroke survivors. For this study, we sought to examine the interaction between fatigue and quality of life after stroke and determine whether reducing fatigue resulted in improved quality of life. In addition, we followed up a subset of patients 12-months after the trial to assess the long-term outcomes of modafinil therapy...
2018: Frontiers in Neurology
Deborah C Mash, Linda Duque, Bryan Page, Kathleen Allen-Ferdinand
Ibogaine may be effective for transitioning opioid and cocaine dependent individuals to sobriety. American and European self-help groups provided public testimonials that ibogaine alleviated drug craving and opioid withdrawal symptoms after only a single dose administration. Preclinical studies in animal models of addiction have provided proof-of-concept evidence in support of these claims. However, the purported therapeutic benefits of ibogaine are based on anecdotal reports from a small series of case reports that used retrospective recruitment procedures...
2018: Frontiers in Pharmacology
Qi Yu, Zirong Huang, Mulan Ren, Qing Chang, Zhongqi Zhang, Susanne Parke
Background: To investigate the efficacy and safety of a combined oral contraceptive containing estradiol valerate and dienogest (EV/DNG) in healthy Asian women. Methods: In this multicenter Phase III study, women received oral EV/DNG in a 28-day regimen for 13 cycles. The primary efficacy endpoint was the number of unintended pregnancies, measured by the Pearl Index (PI); secondary efficacy endpoints included bleeding pattern and cycle control parameters. Adverse events were monitored during the study and overall satisfaction with treatment was determined on completion of the study...
2018: International Journal of Women's Health
Steven Fishbane, Bhupinder Singh, Seema Kumbhat, Wayne A Wisemandle, Nancy E Martin
BACKGROUND AND OBJECTIVES: This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx...
June 19, 2018: Clinical Journal of the American Society of Nephrology: CJASN
Francisco Fernández-Avilés, Ricardo Sanz-Ruiz, Jan Bogaert, Ana Casado Plasencia, Inmaculada Gilaberte, Ann Belmans, María Eugenia Fernández-Santos, Dominique Charron, Miguel Mulet, Raquel Yotti, Itziar Palacios, Manuel Luque, Rafael Sádaba, J A San Roman, Mariano Larman, Pedro L Sánchez, Juan Sanchis, Manuel F Jimenez-Navarro, Piet Claus, Reem Al-Daccak, Eleuterio Lombardo, José Luis Abad, Olga Delarosa, Lucia Corcostegui, Javier Bermejo, Stefan Janssens
<u>Rationale:</u> Allogeneic cardiac stem cells (AlloCSC-01) have shown protective, immunoregulatory and regenerative properties with a robust safety profile in large animal models of heart disease. <u>Objective:</u> To investigate the safety and feasibility of early administration of AlloCSC-01 in patients with ST-segment elevation myocardial infarction (STEMI). <u>Methods and Results:</u> CAREMI was a phase I/II multicenter, randomized, double-blind, placebo-controlled trial in patients with STEMI, LVEF ≤ 45% and infarct size ≥ 25% of left ventricular (LV) mass by cardiac magnetic resonance (MR), who were randomized (2:1) to receive AlloCSC-01 or placebo through the intracoronary route at day 5-7...
June 19, 2018: Circulation Research
Matthew J Reed, Neil R Grubb, Christopher C Lang, Alasdair J Gray, Kirsty Simpson, Allan MacRaild, Christopher J Weir
OBJECTIVES: Diagnosing underlying arrhythmia in ED syncope patients remains problematic. This study investigates diagnostic yield, event prevalence, patient satisfaction and compliance, and influence on resource utilisation of an ambulatory patch monitor in unexplained ED syncope patients. METHODS: Prospective pilot study conducted in a single tertiary ED in Scotland between 17 November 2015 and 16 June 2017 with a historical unmatched comparator group. Patients 16 years or over presenting within 6 hours of unexplained syncope were fitted in the ED with an ambulatory patch ECG recorder (Zio XT monitor), which continuously records a single-lead ECG for up to 14 days...
June 19, 2018: Emergency Medicine Journal: EMJ
G Affaitati, M A Giamberardino, D Lapenna, R Costantini
Topical nonsteroidal anti-inflammatory drugs produce local pain relief while avoiding systemic adverse events, thanks to minimal systemic absorption. This review evaluates the effectiveness and safety of a topical diclofenac preparation, diclofenac epolamine (DHEP) patch 1.3% or diclofenac epolamine patch with heparin as excipient (DHEP+H) in treating mild-to-moderate pain. DHEP patch was associated with significant pain relief and improved function in numerous pain conditions, from minor soft tissue injuries to osteoarthritis and myofascial pain syndromes...
May 2018: Journal of Biological Regulators and Homeostatic Agents
Asha Nayak-Kapoor, Zhonglin Hao, Ramses Sadek, Robin Dobbins, Lisa Marshall, Nicholas N Vahanian, W Jay Ramsey, Eugene Kennedy, Mario R Mautino, Charles J Link, Ray S Lin, Stephanie Royer-Joo, Xiaorong Liang, Laurent Salphati, Kari M Morrissey, Sami Mahrus, Bruce McCall, Andrea Pirzkall, David H Munn, John E Janik, Samir N Khleif
BACKGROUND: Indoleamine-2,3-dioxygenase 1 (IDO1) catalyzes the oxidation of tryptophan into kynurenine and is partially responsible for acquired immune tolerance associated with cancer. The IDO1 small molecule inhibitor navoximod (GDC-0919, NLG-919) is active as a combination therapy in multiple tumor models. METHODS: This open-label Phase Ia study assessed safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of navoximod in patients with recurrent/advanced solid tumors, administered as 50-800 mg BID on a 21/28 day and at 600 mg on a 28/28 day schedule...
June 20, 2018: Journal for Immunotherapy of Cancer
Michelle Woellner, Steffen Hausdorf, Nicole Klein, Philipp Mueller, Martin W Smith, Stefan Kaskel
The quest for advanced designer adsorbents for air filtration and monitoring hazardous trace gases has recently been more and more driven by the need to ensure clean air in indoor, outdoor, and industrial environments. How to increase safety with regard to personal protection in the event of hazardous gas exposure is a critical question for an ever-growing population spending most of their lifetime indoors, but is also crucial for the chemical industry in order to protect future generations of employees from potential hazards...
June 19, 2018: Advanced Materials
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