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ELAIN trial

Vibeke Strand, Elaine Husni, Jenny Griffith, Zheng-Yi Zhou, James Signorovitch, Arijit Ganguli
INTRODUCTION: The present study aimed to evaluate clinical outcomes and costs associated with timely versus delayed use of tumor necrosis factor inhibitors (TNFis) among patients with moderately to severely active psoriatic arthritis (PsA) with and without moderate/severe psoriasis (Ps) from a US payer's perspective. METHODS: An economic model evaluated PsA patients initially treated with a TNFi (timely TNFi use) or apremilast (delayed TNFi use). Patients without joint (American College of Rheumatology 20%, [ACR20]) improvement either switched TNFis or initiated one...
September 15, 2016: Rheumatol Ther
Saloumeh Kadkhodayan Fischer, Melissa Cheu, Kun Peng, John Lowe, James Araujo, Elaine Murray, Dana McClintock, John Matthews, Patricia Siguenza, An Song
Host cell proteins are manufacturing process-related impurities that may co-purify with the product despite extensive efforts to optimize the purification process. The risks associated with these impurities can vary and may be patient and/or therapeutic dependent. Therefore, it is critical to monitor and control the levels of these impurities in products and their potential impact on safety and efficacy. Lebrikizumab is a humanized immunoglobulin G4 monoclonal antibody (mAb) that binds specifically to soluble interleukin 13...
October 13, 2016: AAPS Journal
Lan Chi Vo, Christopher Snyder, Courtney McCracken, Christopher J McDougle, James T McCracken, Michael G Aman, Elaine Tierney, L Eugene Arnold, Daniel Levi, Michael Kelleman, Deirdre Carroll, John Morrissey, Benedetto Vitiello, Lawrence Scahill
OBJECTIVES: Risperidone is approved for the treatment of serious behavioral problems in children with autism spectrum disorder (ASD). This study examined the effects of risperidone on cardiac conduction in children with ASD. METHODS: Data were collected from an 8-week, five-site trial conducted by the Research Units on Pediatric Psychopharmacology Autism Network. Children (age 5-17 years) were randomly assigned to risperidone (n = 49) or placebo (n = 52) under double-blind conditions...
October 11, 2016: Journal of Child and Adolescent Psychopharmacology
Patrícia Santos, Ana P Herrmann, Radharani Benvenutti, Guilherme Noetzold, Franciele Giongo, Clarissa S Gama, Angelo L Piato, Elaine Elisabetsky
Anxiety disorders are highly prevalent and often result in poor quality of life. Available anxiolytics show significant adverse effects as well as partial efficacy in a sizable part of patients. Innovative treatments with more favorable risk-benefit ratio are sorely needed. A growing body of clinical data indicates the benefits of N-acetylcysteine (NAC) in psychiatric conditions. NAC modulates antioxidant, glutamatergic, inflammatory and neurotrophic pathways in the central nervous system, all of which are relevant to anxiety pathology...
October 7, 2016: Behavioural Brain Research
Melanie P J Schellekens, Rie Tamagawa, Laura E Labelle, Michael Speca, Joanne Stephen, Elaine Drysdale, Sarah Sample, Barbara Pickering, Dale Dirkse, Linette Lawlor Savage, Linda E Carlson
Despite growing evidence in support of mindfulness as an underlying mechanism of mindfulness-based interventions (MBIs), it has been suggested that nonspecific therapeutic factors, such as the experience of social support, may contribute to the positive effects of MBIs. In the present study, we examined whether change in mindfulness and/or social support mediated the effect of Mindfulness-Based Cancer Recovery (MBCR) compared to another active intervention (i.e. Supportive Expressive Group Therapy (SET)), on change in mood disturbance, stress symptoms and quality of life...
October 8, 2016: Journal of Behavioral Medicine
Kamila Rasova, Jenny Freeman, Patricia Martinkova, Marketa Pavlikova, Davide Cattaneo, Johanna Jonsdottir, Thomas Henze, Ilse Baert, Paul Van Asch, Carme Santoyo, Tori Smedal, Antonie Giæver Beiske, Małgorzata Stachowiak, Mariusz Kovalewski, Una Nedeljkovic, Daphne Bakalidou, José Manuel Alves Guerreiro, Ylva Nilsagård, Erieta Nikolikj Dimitrova, Mario Habek, Kadriye Armutlu, Cécile Donzé, Elaine Ross, Ana Maria Ilie, Andrej Martić, Anders Romberg, Peter Feys
BACKGROUND: Understanding the organisational set-up of physiotherapy services across different countries is increasingly important as clinicians around the world use evidence to improve their practice. This also has to be taken into consideration when multi-centre international clinical trials are conducted. This survey aimed to systematically describe organisational aspects of physiotherapy services for people with multiple sclerosis (MS) across Europe. METHODS: Representatives from 72 rehabilitation facilities within 23 European countries completed an online web-based questionnaire survey between 2013 and 2014...
October 6, 2016: BMC Health Services Research
Linda S Chesterton, Krysia S Dziedzic, Danielle A van der Windt, Graham Davenport, Helen L Myers, Trishna Rathod, Milica Blagojevic-Bucknall, Sue M Jowet, Claire Burton, Edward Roddy, Elaine M Hay
BACKGROUND: Patients diagnosed with idiopathic mild to moderate carpal tunnel syndrome (CTS) are usually managed in primary care and commonly treated with night splints and/or corticosteroid injection. The comparative effectiveness of these interventions has not been reliably established nor investigated in the medium and long term. The primary objective of this trial is to investigate whether corticosteroid injection is effective in reducing symptoms and improving hand function in mild to moderate CTS over 6 weeks when compared with night splints...
October 6, 2016: BMC Musculoskeletal Disorders
George P Obita, Elaine G Boland, David C Currow, Miriam J Johnson, Jason W Boland
CONTEXT: Somatostatin analogues are commonly used to relieve symptoms in malignant bowel obstruction (MBO) but are more expensive than other anti-secretory agents. OBJECTIVE: To evaluate the evidence of effectiveness of somatostatin analogues compared to placebo and/or other pharmacological agents in relieving vomiting in patients with inoperable MBO. METHOD: MEDLINE, EMBASE, CINAHL, The Cochrane Controlled Trials Register databases were systematically searched; reference lists of relevant articles were hand-searched...
September 30, 2016: Journal of Pain and Symptom Management
Amritha Bhat, Nancy K Grote, Joan Russo, Mary Jane Lohr, Hyunzee Jung, Caroline E Rouse, Elaine C Howell, Jennifer L Melville, Kathy Carson, Wayne Katon
OBJECTIVE: The study examined the effectiveness of a perinatal collaborative care intervention in moderating the effects of adverse neonatal birth events on risks of postpartum depressive symptoms and impaired functioning among women of lower socioeconomic status with antenatal depression. METHODS: A randomized controlled trial with blinded outcome assessments was conducted in ten public health centers, comparing MOMCare (choice of brief interpersonal psychotherapy, pharmacotherapy, or both) with intensive maternity support services (MSS-Plus)...
October 3, 2016: Psychiatric Services: a Journal of the American Psychiatric Association
Rachel S Kerr, Sharon Love, Eva Segelov, Elaine Johnstone, Beverly Falcon, Peter Hewett, Andrew Weaver, David Church, Claire Scudder, Sarah Pearson, Patrick Julier, Francesco Pezzella, Ian Tomlinson, Enric Domingo, David J Kerr
BACKGROUND: Antiangiogenic agents have established efficacy in the treatment of metastatic colorectal cancer. We investigated whether bevacizumab could improve disease-free survival in the adjuvant setting after resection of the primary tumour. METHODS: For the open-label, randomised, controlled QUASAR 2 trial, which was done at 170 hospitals in seven countries, we recruited patients aged 18 years or older with WHO performance status scores of 0 or 1 who had undergone potentially curative surgery for histologically proven stage III or high-risk stage II colorectal cancer...
September 19, 2016: Lancet Oncology
Ralph C Wang, Rebecca Smith-Bindman, Evans Whitaker, Jersey Neilson, Isabel Elaine Allen, Marshall L Stoller, Jahan Fahimi
STUDY OBJECTIVE: Tamsulosin is recommended for patients receiving a diagnosis of a ureteral stone less than 10 mm who do not require immediate urologic intervention. Because of conflicting results from recent meta-analyses and large randomized controlled trials, the efficacy of tamsulosin is unclear. We perform a systematic review and meta-analysis to investigate the effect of tamsulosin on stone passage in patients receiving a diagnosis of ureteral stone. METHODS: MEDLINE, EMBASE, and CENTRAL databases were searched without language restriction through November 2015 for studies assessing the efficacy of tamsulosin and using a double-blind, randomized, controlled trial design...
September 7, 2016: Annals of Emergency Medicine
Sangeeta Jain, Kusum Menon, Dominique Piquette, Ronald Gottesman, James Hutchison, Elaine Gilfoyle, Canadian Critical Care Trials Group
Background. Conducting research is expected from many clinicians' professional profile, yet many do not have advanced research degrees. Research training during residency is variable amongst institutions and research education needs of trainees are not well understood. Objective. To understand needs of critical care trainees regarding research education. Methods. Canadian critical care trainees, new critical care faculty, program directors, and research coordinators were surveyed regarding research training, research expectations, and support within their programs...
2016: Canadian Respiratory Journal: Journal of the Canadian Thoracic Society
Paula Mulvenna, Matthew Nankivell, Rachael Barton, Corinne Faivre-Finn, Paula Wilson, Elaine McColl, Barbara Moore, Iona Brisbane, David Ardron, Tanya Holt, Sally Morgan, Caroline Lee, Kathryn Waite, Neil Bayman, Cheryl Pugh, Benjamin Sydes, Richard Stephens, Mahesh K Parmar, Ruth E Langley
BACKGROUND: Whole brain radiotherapy (WBRT) and dexamethasone are widely used to treat brain metastases from non-small cell lung cancer (NSCLC), although there have been no randomised clinical trials showing that WBRT improves either quality of life or overall survival. Even after treatment with WBRT, the prognosis of this patient group is poor. We aimed to establish whether WBRT could be omitted without a significant effect on survival or quality of life. METHODS: The Quality of Life after Treatment for Brain Metastases (QUARTZ) study is a non-inferiority, phase 3 randomised trial done at 69 UK and three Australian centres...
September 2, 2016: Lancet
Gerson Weiss, Sam Teichman, Dennis Stewart, David Nader, Susan Wood, Peter Breining, Elaine Unemori
BACKGROUND: Nonclinical studies indicate that the hormone relaxin is a good candidate for a safe cervical ripening agent that does not cause uterine contractions. METHODS: This Phase II study (conducted November 2, 2005-October 20, 2006) was a randomised, double blind, placebo controlled trial testing 24-h intravenous infusion of serelaxin (recombinant human relaxin) or placebo for cervical ripening in 72 healthy, primiparous women. Eligible subjects had a singleton pregnancy ≥40 weeks, were planned for elective induction, had vertex presentation of the fetus, intact membranes and a Bishop score at screening ≤4...
2016: BMC Pregnancy and Childbirth
Ina S Santos, Diego G Bassani, Alicia Matijasevich, Camila S Halal, Bianca Del-Ponte, Suélen Henriques da Cruz, Luciana Anselmi, Elaine Albernaz, Michelle Fernandes, Luciana Tovo-Rodrigues, Mariangela F Silveira, Pedro C Hallal
BACKGROUND: Sleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants. METHODS: The study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age...
2016: BMC Psychiatry
Jacqueline De Souza Silva, Silvia Elaine Pereira, Carlos José Saboya Sobrinho, Andréa Ramalho
INTRODUCTION: The rise in prevalence of obesity has occurred concomitantly to that of vitamin D deficiency (VDD). The aim of this narrative review was to describe the relationship between obesity and such related diseases as VDD in adolescents, in an effort to warn of the risks of this deficiency during this period of growth and development. METHODS: We searched the electronic databases PubMed, Medline, Scielo, Science Direct and Lilacs for articles from between 2000 and 2015 on the topics obesity and obesity-related diseases and VDD in adolescents...
2016: Nutrición Hospitalaria: Organo Oficial de la Sociedad Española de Nutrición Parenteral y Enteral
Christopher K Y Chan, Alice Mason, Cyrus Cooper, Elaine Dennison
INTRODUCTION: Osteoporosis is a significant public health issue affecting over half of women aged over 50. With an aging population, its importance is set to increase further over time. Prevention of fragility fractures avoids significant mortality and morbidity as well as saving significant direct and indirect costs to the economy. In this review, we discuss existing treatments to contextualize the treatment landscape, and demonstrate how our understanding of bone pathophysiology has led to novel therapies-in the form of combinations and altered durations of existing treatments, as well as newer drug therapies...
September 2016: British Medical Bulletin
Adriana D B Vizzotto, Diego L Celestino, Patricia C Buchain, Alexandra M Oliveira, Graça M R Oliveira, Elaine S Di Sarno, Isabel C Napolitano, Helio Elkis
Schizophrenia is a chronic disabling mental disorder that involves impairments in several cognitive domains, especially in executive functions (EF), as well as impairments in functional performance. This is particularly true in patients with Treatment-Resistant Schizophrenia (TRS). The aim of this study was to test the efficacy of the Occupational Goal Intervention (OGI) method for the improvement of EF in patients with TRS. In this randomized, controlled, single-blind pilot study, 25 TRS patients were randomly assigned to attend 30 sessions of either OGI or craft activities (control) over a 15-week period and evaluated by the Behavioural Assessment of the Dysexecutive Syndrome (BADS) as the primary outcome and the Direct Assessment of Functional Status (DAFS-BR) as well as the Independent Living Skills Survey (ILSS-BR) as secondary outcomes, all adapted for the Brazilian population...
November 30, 2016: Psychiatry Research
Elaine Ku, Jennifer Gassman, Lawrence J Appel, Miroslaw Smogorzewski, Mark J Sarnak, David V Glidden, George Bakris, Orlando M Gutiérrez, Lee A Hebert, Joachim H Ix, Janice Lea, Michael S Lipkowitz, Keith Norris, David Ploth, Velvie A Pogue, Stephen G Rostand, Edward D Siew, Mohammed Sika, C Craig Tisher, Robert Toto, Jackson T Wright, Christina Wyatt, Chi-Yuan Hsu
We recently showed an association between strict BP control and lower mortality risk during two decades of follow-up of prior participants in the Modification of Diet in Renal Disease (MDRD) trial. Here, we determined the risk of ESRD and mortality during extended follow-up of the African American Study of Kidney Disease and Hypertension (AASK) trial. We linked 1067 former AASK participants with CKD previously randomized to strict or usual BP control (mean arterial pressure ≤92 mmHg or 102-107 mmHg, respectively) to the US Renal Data System and Social Security Death Index; 397 patients had ESRD and 475 deaths occurred during a median follow-up of 14...
August 11, 2016: Journal of the American Society of Nephrology: JASN
Christopher A Wassif, Lisa Kratz, Susan E Sparks, Courtney Wheeler, Simona Bianconi, Andrea Gropman, Karim A Calis, Richard I Kelley, Elaine Tierney, Forbes D Porter
BACKGROUND: Smith-Lemli-Opitz syndrome (SLOS) is a multiple malformation/cognitive impairment syndrome characterized by the accumulation of 7-dehydrocholesterol, a precursor sterol of cholesterol. Simvastatin, a 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor that crosses the blood-brain barrier, has been proposed for the treatment of SLOS based on in vitro and in vivo studies suggesting that simvastatin increases the expression of hypomorphic DHCR7 alleles. METHODS: Safety and efficacy of simvastatin therapy in 23 patients with mild to typical SLOS were evaluated in a randomized, double-blind, placebo-controlled trial...
August 11, 2016: Genetics in Medicine: Official Journal of the American College of Medical Genetics
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