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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
#1
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/28814873/safety-and-efficacy-of-paliperidone-palmitate-1-month-formulation-in-chinese-patients-with-schizophrenia-a-25-week-open-label-multicenter-phase-iv-study
#2
Jingping Zhao, Lehua Li, Jianguo Shi, Yi Li, Xiufeng Xu, Keqing Li, Lili Zhang, Shangli Cai, Yu Feng, Jianmin Zhuo, Weihong Liu, Huafei Lu
RATIONALE: Long-acting injectable (LAI) paliperidone palmitate 1-month formulation (PP1M) has demonstrated acceptable tolerability and favorable clinical outcomes in Western and Asian patients with schizophrenia. Hence, analysis of the outcomes of long-term PP1M treatment specifically in Chinese patients is of interest. OBJECTIVE: The aim of this study is to evaluate the long-term safety and efficacy of PP1M treatment in Chinese patients with schizophrenia. METHODS: In this 25-week, open-label, Phase IV study, patients (18-65 years) diagnosed with schizophrenia and having a baseline Positive and Negative Syndrome Scale (PANSS) total score of 60-120 (inclusive) were enrolled...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28802512/cangrelor-versus-clopidogrel-on-a-background-of-unfractionated-heparin-from-champion-phoenix
#3
Muthiah Vaduganathan, Robert A Harrington, Gregg W Stone, Ph Gabriel Steg, C Michael Gibson, Christian W Hamm, Matthew J Price, Efthymios N Deliargyris, Jayne Prats, Kenneth W Mahaffey, Harvey D White, Deepak L Bhatt
Cangrelor is approved for use during percutaneous coronary intervention (PCI) and is administered with different parenteral anticoagulants. We examined the efficacy and safety of cangrelor in the subgroup of patients who received unfractionated heparin (UFH) during PCI in the modified intention-to-treat population of the randomized CHAMPION PHOENIX trial (cangrelor vs clopidogrel; n = 10,939). The primary efficacy end point was the composite of death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis (ST) at 48 hours...
July 18, 2017: American Journal of Cardiology
https://www.readbyqxmd.com/read/28800195/pharmacokinetics-safety-and-tolerability-of-glecaprevir-and-pibrentasvir-in-healthy-white-chinese-and-japanese-adult-subjects
#4
Chih-Wei Lin, Sandeep Dutta, Bifeng Ding, Tianli Wang, Neddie Zadeikis, Armen Asatryan, Jens Kort, Andrew Campbell, Thomas Podsadecki, Wei Liu
Glecaprevir and pibrentasvir are direct-acting antiviral agents being developed as combination therapy for the treatment of chronic hepatitis C virus infection. The aim of the present studies was to assess the effect of race and ethnicity (white, Han Chinese, Japanese) on the pharmacokinetics and safety of multiple oral doses of glecaprevir and pibrentasvir given alone and in combination. Two multiple-dose, single-center, phase 1 studies were conducted in healthy adult male and female subjects (n = 170) of respective Asian and white race/ethnicity...
August 11, 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28790779/device-associated-healthcare-associated-infections-da-hai-and-the-caveat-of-multiresistance-in-a-multidisciplinary-intensive-care-unit
#5
Inam Danish Khan, Atoshi Basu, Sheshadri Kiran, Shaleen Trivedi, Priyanka Pandit, Anupam Chattoraj
BACKGROUND: Device-Associated Healthcare-Associated Infections (DA-HAI), including Ventilator-Associated Pneumonia (VAP), Central-Line-Associated Blood Stream Infection (CLABSI), and Catheter-Related Urinary Tract Infection (CAUTI), are considered as principal contributors to healthcare hazard and threat to patient safety as they can cause prolonged hospital stay, sepsis, and mortality in the ICU. The study intends to characterize DA-HAI in a tertiary care multidisciplinary ICU of a teaching hospital in eastern India...
July 2017: Medical Journal, Armed Forces India
https://www.readbyqxmd.com/read/28763548/effect-of-oral-methylprednisolone-on-clinical-outcomes-in-patients-with-iga-nephropathy-the-testing-randomized-clinical-trial
#6
RANDOMIZED CONTROLLED TRIAL
Jicheng Lv, Hong Zhang, Muh Geot Wong, Meg J Jardine, Michelle Hladunewich, Vivek Jha, Helen Monaghan, Minghui Zhao, Sean Barbour, Heather Reich, Daniel Cattran, Richard Glassock, Adeera Levin, David Wheeler, Mark Woodward, Laurent Billot, Tak Mao Chan, Zhi-Hong Liu, David W Johnson, Alan Cass, John Feehally, Jürgen Floege, Giuseppe Remuzzi, Yangfeng Wu, Rajiv Agarwal, Hai-Yan Wang, Vlado Perkovic
Importance: Guidelines recommend corticosteroids in patients with IgA nephropathy and persistent proteinuria, but the effects remain uncertain. Objective: To evaluate the efficacy and safety of corticosteroids in patients with IgA nephropathy at risk of progression. Design, Setting, and Participants: The Therapeutic Evaluation of Steroids in IgA Nephropathy Global (TESTING) study was a multicenter, double-blind, randomized clinical trial designed to recruit 750 participants with IgA nephropathy (proteinuria greater than 1 g/d and estimated glomerular filtration rate [eGFR] of 20 to 120 mL/min/1...
August 1, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28752663/platelet-production-from-induced-pluripotent-stem-cells
#7
N Sugimoto, K Eto
Ex vivo production of human platelets has been pursued as an alternative measure to resolve limitations in the supply and safety of current platelet transfusion products. To this end, induced pluripotent stem cells (iPSCs) are considered an ideal global source, as they are not only pluripotent and self-renewing, but are also available from basically any person, have relatively few ethical issues, and are easy to manipulate. From human iPSCs, megakaryocyte (MK) lines with robust proliferation capacity have been established by the introduction of specified sets of genes...
July 28, 2017: Journal of Thrombosis and Haemostasis: JTH
https://www.readbyqxmd.com/read/28740204/safety-and-tolerability-of-topically-administered-autologous-apoptotic-pbmc-secretome-aposec-in-dermal-wounds-a-randomized-phase-1-trial-marsyas-i%C3%AF
#8
Elisabeth Simader, Denise Traxler, Mohammad Mahdi Kasiri, Helmut Hofbauer, Michael Wolzt, Christoph Glogner, Angela Storka, Michael Mildner, Ghazaleh Gouya, Alexandra Geusau, Carola Fuchs, Claudia Eder, Alexandra Graf, Michaela Schaden, Bahar Golabi, Marie-Bernadette Aretin, Susanne Suessner, Christian Gabriel, Walter Klepetko, Erwin Tschachler, Hendrik Jan Ankersmit
Developing effective therapies against chronic wound healing deficiencies is a global priority. Thus we evaluated the safety of two different doses of topically administered autologous APOSEC, the secretome of apoptotic peripheral blood mononuclear cells (PBMCs), in healthy male volunteers with artificial dermal wounds. Ten healthy men were enrolled in a single-center, randomized, double-blinded, placebo-controlled phase 1 trial. Two artificial wounds at the upper arm were generated using a 4-mm punch biopsy...
July 24, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28729836/an-overview-of-herbal-products-and-secondary-metabolites-used-for-management-of-type-two-diabetes
#9
REVIEW
Ajda Ota, Nataša P Ulrih
Diabetes mellitus is a common effect of uncontrolled high blood sugar and it is associated with long-term damage, dysfunction, and failure of various organs. In the adult population, the global prevalence of diabetes has nearly doubled since 1980. Without effective prevention and management programs, the continuing significant rise in diabetes will have grave consequences on the health and lifespan of the world population, and also on the world economy. Supplements can be used to correct nutritional deficiencies or to maintain an adequate intake of certain nutrients...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28725042/global-deregulation-of-ginseng-products-may-be-a-safety-hazard-to-warfarin-takers-solid-evidence-of-ginseng-warfarin-interaction
#10
Haiyan Dong, Ji Ma, Tao Li, Yingying Xiao, Ning Zheng, Jian Liu, Yu Gao, Jingwei Shao, Lee Jia
Recent global deregulation of ginseng as the table food raises our concern about the possible ginseng-warfarin interaction that could be life-threatening to patients who take warfarin for preventing fatal strokes and thromboembolism while using ginseng products for bioenergy recovery. Here we show that quality-control ginsenosides, extracted from ginseng and containing its major active ingredients, produce dose- and time-dependent antagonism in rats against warfarin's anti-coagulation assessed by INR and rat thrombosis model...
July 19, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28721051/effectiveness-of-amisulpride-in-chinese-patients-with-predominantly-negative-symptoms-of-schizophrenia-a-subanalysis-of-the-escape-study
#11
Ying Liang, Xin Yu
BACKGROUND: Effective management strategies for the negative symptoms of schizophrenia remain an unmet need, and data on the use of antipsychotics in this population are scarce, particularly in Chinese patients. Therefore, we investigated amisulpride for the treatment of Chinese patients with predominantly negative symptoms of schizophrenia. METHODS: This post hoc subanalysis of the prospective Effectiveness and Safety of Amisulpride in Chinese Patients with Schizophrenia (ESCAPE) study included adult Chinese patients with an International Classification of Diseases-10 diagnosis of schizophrenia and predominantly negative symptoms, who received amisulpride for 8 weeks...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/28712074/efficacy-and-safety-of-shp465-mixed-amphetamine-salts-in-the-treatment-of-attention-deficit-hyperactivity-disorder-in-adults-results-of-a-randomized-double-blind-placebo-controlled-forced-dose-clinical-study
#12
Richard H Weisler, Michael Greenbaum, Valerie Arnold, Ming Yu, Brian Yan, Margo Jaffee, Brigitte Robertson
OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of SHP465 mixed amphetamine salts (MAS) in adults with attention-deficit/hyperactivity disorder (ADHD). METHODS: Eligible adults [aged 18-55 years; meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ADHD criteria; baseline ADHD Rating Scale with Adult Prompts (ADHD-RS-AP) total scores ≥28] were randomized 1:1:1 to placebo or forced-dose SHP465 MAS (12...
August 2017: CNS Drugs
https://www.readbyqxmd.com/read/28694025/the-potential-of-viral-metagenomics-in-blood-transfusion-safety
#13
V Sauvage, J Gomez, L Boizeau, S Laperche
Thanks to the significant advent of high throughput sequencing in the last ten years, it is now possible via metagenomics to define the spectrum of the microbial sequences present in human blood samples. Therefore, metagenomics sequencing appears as a promising approach for the identification and global surveillance of new, emerging and/or unexpected viruses that could impair blood transfusion safety. However, despite considerable advantages compared to the traditional methods of pathogen identification, this non-targeted approach presents several drawbacks including a lack of sensitivity and sequence contaminant issues...
July 7, 2017: Transfusion Clinique et Biologique: Journal de la Société Française de Transfusion Sanguine
https://www.readbyqxmd.com/read/28685960/platelet-derived-mitochondria-display-embryonic-stem-cell-markers-and-improve-pancreatic-islet-%C3%AE-cell-function-in-humans
#14
Yong Zhao, Zhaoshun Jiang, Elias Delgado, Heng Li, Huimin Zhou, Wei Hu, Marcos Perez-Basterrechea, Anna Janostakova, Qidong Tan, Jing Wang, Mao Mao, Zhaohui Yin, Ye Zhang, Ying Li, Quanhai Li, Jing Zhou, Yunxiang Li, Eva Martinez Revuelta, Jose Maria García-Gala, Honglan Wang, Silvia Perez-Lopez, Maria Alvarez-Viejo, Edelmiro Menendez, Thomas Moss, Edward Guindi, Jesus Otero
Diabetes is a major global health issue and the number of individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) increases annually across multiple populations. Research to develop a cure must overcome multiple immune dysfunctions and the shortage of pancreatic islet β cells, but these challenges have proven intractable despite intensive research effort more than the past decades. Stem Cell Educator (SCE) therapy-which uses only autologous blood immune cells that are externally exposed to cord blood stem cells adhering to the SCE device, has previously been proven safe and effective in Chinese and Spanish subjects for the improvement of T1D, T2D, and other autoimmune diseases...
August 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28670544/randomized-placebo-control-study-of-metformin-in-psoriasis-patients-with-metabolic-syndrome-systemic-treatment-cohort
#15
Surjit Singh, Anil Bhansali
BACKGROUND: Psoriasis has been found to be associated with obesity, metabolic syndrome (MS), diabetes, and cardiovascular risk factors. Metformin treatment showed improvement in cardiovascular risk factors and hyperinsulinemia. OBJECTIVE: To evaluate the efficacy and safety of metformin in psoriasis patients with MS. MATERIALS AND METHODS: This was a single-center, parallel-group, randomized, open-label study with blinded end point assessment of metformin (1000 mg once daily for 12 weeks; n = 20) and placebo (n = 18) in psoriasis patients with MS...
July 2017: Indian Journal of Endocrinology and Metabolism
https://www.readbyqxmd.com/read/28667569/long-term-safety-and-efficacy-of-lisdexamfetamine-dimesylate-in-children-and-adolescents-with-adhd-a-phase-iv-2-year-open-label-study-in-europe
#16
David R Coghill, Tobias Banaschewski, Peter Nagy, Isabel Hernández Otero, César Soutullo, Brian Yan, Beatriz Caballero, Alessandro Zuddas
BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is increasingly recognized as a persistent disorder requiring long-term management. OBJECTIVES: Our objective was to evaluate the 2-year safety and efficacy of lisdexamfetamine dimesylate (LDX) in children and adolescents with ADHD. METHODS: Participants (aged 6-17 years) with ADHD received open-label, dose-optimized LDX 30, 50, or 70 mg/day for 104 weeks. Safety monitoring included treatment-emergent adverse events (TEAEs), vital signs, electrocardiography, and growth...
July 2017: CNS Drugs
https://www.readbyqxmd.com/read/28639001/sanguinate%C3%A2-pegylated-carboxyhemoglobin-bovine-improves-cerebral-blood-flow-to-vulnerable-brain-regions-at-risk-of-delayed-cerebral-ischemia-after-subarachnoid-hemorrhage
#17
Rajat Dhar, Hemant Misra, Michael N Diringer
BACKGROUND: Delayed cerebral ischemia (DCI) after subarachnoid hemorrhage (SAH) has been linked to focal reductions in cerebral blood flow (CBF) and microvascular impairments in oxygen delivery. Effective therapies that restore flow and oxygen transport to vulnerable brain regions are currently lacking. SANGUINATE is a dual-action carbon monoxide-releasing and hemoglobin-based oxygen transfer agent with efficacy in animal models of focal brain ischemia and tolerability in patients with sickle cell disease...
June 21, 2017: Neurocritical Care
https://www.readbyqxmd.com/read/28621456/absorption-distribution-and-excretion-of-four-forms-of-titanium-dioxide-pigment-in-the-rat
#18
Thomas P Farrell, Berna Magnuson
Titanium dioxide (TiO2 ) is a white color additive that has a long history of global approval and use in food. There is, however, considerable confusion regarding the applicability of the biological effects of novel, engineered, nano-sized forms of TiO2 developed for nonpigmentary applications to the safety of oral exposure to food grade TiO2 pigment. The objective of this study was to assess the absorption, distribution, and routes of excretion in rats after oral exposure to food grade TiO2 . Four different grades of TiO2 (200 ppm) or control (0 ppm) diets were fed to rats for 7 consecutive days, followed by control diet only for 1, 24, or 72 h...
June 16, 2017: Journal of Food Science
https://www.readbyqxmd.com/read/28611661/discovery-and-development-of-calcium-channel-blockers
#19
REVIEW
Théophile Godfraind
In the mid 1960s, experimental work on molecules under screening as coronary dilators allowed the discovery of the mechanism of calcium entry blockade by drugs later named calcium channel blockers. This paper summarizes scientific research on these small molecules interacting directly with L-type voltage-operated calcium channels. It also reports on experimental approaches translated into understanding of their therapeutic actions. The importance of calcium in muscle contraction was discovered by Sidney Ringer who reported this fact in 1883...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28600751/central-and-peripheral-nervous-system-disorders-following-ivermectin-mass-administration-a-descriptive-study-based-on-the-democratic-republic-of-congo-pharmacovigilance-system
#20
Didier Nzolo, Francis Anto, Sarah Hailemariam, Didier Bakajika, Daniel Muteba, Jean-Claude Makenga, Gautier Mesia, Celestin Nsibu, Samuel Mampunza, Gaston Tona
INTRODUCTION: The mainstay of onchocerciasis control currently is mass administration of ivermectin; however, this may be associated with serious adverse events, including deaths, when administered in areas where onchocerciasis and loiasis are co-endemic. OBJECTIVES: The objective of the current study was to describe the central and peripheral nervous system disorders that occurred after mass administration of ivermectin in Democratic Republic of Congo (DRC). METHODS: This is a retrospective descriptive study involving a review of data on adverse events related to mass administration of ivermectin...
June 9, 2017: Drugs—Real World Outcomes
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