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https://www.readbyqxmd.com/read/29149437/a-blinded-randomized-placebo-controlled-study-to-investigate-the-efficacy-and-safety-of-ferric-carboxymaltose-in-iron-deficient-patients-with-fibromyalgia
#1
Chad S Boomershine, Todd A Koch, David Morris
INTRODUCTION: This study sought to compare efficacy and safety of ferric carboxymaltose vs. placebo in iron-deficient patients with fibromyalgia. METHODS: This blinded, placebo-controlled, phase 2 study randomized adults with fibromyalgia and Revised Fibromyalgia Impact Questionnaire (FIQR) scores ≥ 60, ferritin levels < 0.05 µg/ml, and transferrin saturation < 20% (1:1) to receive ferric carboxymaltose [15 mg/kg (up to 750 mg)], or placebo (15 cc normal saline) intravenously on study days 0 and 5...
November 17, 2017: Rheumatology and Therapy
https://www.readbyqxmd.com/read/29148881/ultrarapid-influence-of-buprenorphine-on-major-depression-in-opioid-dependent-patients-a-double-blind-randomized-clinical-trial
#2
Jamshid Ahmadi, Mina Sefidfard Jahromi
OBJECTIVE: To examine the impact of different doses of buprenorphine on depression symptoms in opioid dependent inpatient over a three-day interval, using a randomized clinical trial design (RCT). DESIGN: Patients were randomized and assigned to three groups. PARTICIPANTS: Forty males who were admitted to an inpatient psychiatric unit and who fulfilled the DSM-5 criteria for both opioid dependence and major depressive disorder. INTERVENTION: Patients randomly received 32 mg, 64 mg, or 96 mg of buprenorphine as a single high dose...
November 17, 2017: Substance Use & Misuse
https://www.readbyqxmd.com/read/29147810/acceptability-of-a-tenofovir-disoproxil-fumarate-vaginal-ring-for-hiv-prevention-among-women-in-new-york-city
#3
Dana Watnick, Marla J Keller, Kimberly Stein, Laurie J Bauman
Vaginal rings for pre-exposure prophylaxis are a female-initiated HIV prevention method that does not require daily or coitally-dependent dosing. As part of a randomized placebo-controlled trial of a tenofovir disoproxil fumarate intravaginal ring, we assessed product acceptability through in-depth interviews with 18 women during and after 14 days of continuous use. Women reported that the ring was comfortable with few side effects, regardless of experimental arm. However, interest in future use by this cohort was modest for several reasons including: low self-perceived HIV risk; concern that use implied promiscuity; potential for interference with relationship formation and trust; concern for interference with menstruation and cleanliness; and worries about partners' acceptability and sexual pleasure...
November 16, 2017: AIDS and Behavior
https://www.readbyqxmd.com/read/29147795/preoperative-pregabalin-has-no-effect-on-intraoperative-neurophysiological-monitoring-in-adolescents-undergoing-posterior-spinal-fusion-for-spinal-deformities-a-double-blind-randomized-placebo-controlled-clinical-trial
#4
Linda Helenius, Antti Puhakka, Tuula Manner, Olli Pajulo, Ilkka Helenius
PURPOSE: This study was designed to evaluate the effect of preoperative pregabalin on intraoperative neurophysiological monitoring in adolescents undergoing surgery for spinal deformities. METHODS: Thirty-one adolescents undergoing posterior spinal fusion were randomized to receive preoperatively either pregabalin 2 mg/kg twice daily or placebo. The ability to make reliable intraoperative neurophysiological measurements, transcranial motor (MEPs) and sensory evoked potentials (SSEP) was evaluated...
November 17, 2017: European Spine Journal
https://www.readbyqxmd.com/read/29147138/an-update-on-prucalopride-in-the-treatment-of-chronic-constipation
#5
REVIEW
Anam Omer, Eamonn M M Quigley
Chronic constipation (CC) is a highly prevalent and often under-appreciated gastrointestinal disorder associated with significant impairment in quality of life. Symptoms of constipation are typically present for a number of years prior to a patient seeking help. Lifestyle modifications followed by, or coupled with, over-the-counter laxatives represent the initial treatment option; however, relief for many is limited and dissatisfaction rates for these approaches remain high. Over recent years, therefore, considerable effort has been exerted on the development of novel pharmacological approaches...
November 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29147135/randomized-clinical-trial-efficacy-and-safety-of-plecanatide-in-the-treatment-of-chronic-idiopathic-constipation
#6
Michael DeMicco, Laura Barrow, Bernadette Hickey, Kunwar Shailubhai, Patrick Griffin
Background: Plecanatide, with the exception of a single amino acid replacement, is identical to human uroguanylin and is approved in the United States for adults with chronic idiopathic constipation (CIC). This double-blind, placebo-controlled, phase III study evaluated the efficacy and safety of plecanatide versus placebo in CIC. Methods: Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445)...
November 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29147120/a-comparative-study-of-the-effect-of-green-tea-and-sour-tea-on-blood-pressure-and-lipid-profile-in-healthy-adult-men
#7
Marzieh Kafeshani, Mohammad Hasan Entezari, Jahangir Karimian, Makan Pourmasoumi, Mohammad Reza Maracy, Mohammad Reza Amini, Amir Hadi
BACKGROUND: Cardiovascular diseases (CVD) are a set of metabolic disorders affecting heart and blood vessels. Green tea and sour tea (Hibiscus sabdariffa L.) have attracted significant attention recently due to their high popularity, nutrient profile and therapeutic effects. The aim of the present study was to compare the effects of green tea and sour tea supplementation on blood pressure and lipid profile in healthy adult men. METHODS: This randomized, double-blind, placebo-controlled trial included 54 healthy adult men...
May 2017: ARYA Atherosclerosis
https://www.readbyqxmd.com/read/29146890/effectiveness-of-topical-green-tea-against-multidrug-resistant-staphylococcus-aureus-in-cases-of-primary-pyoderma-an-open-controlled-trial
#8
Nagaraju Umashankar, Belliappa Pemmanda, P Gopkumar, A J Hemalatha, Priya K Sundar, H V Prashanth
BACKGROUND: Antimicrobial activity of green tea against Staphylococcus aureus both in vitro and in vivo has been reported recently. Studies on clinical efficacy and safety of green tea as antibacterial agent against S. aureus in human cases are rare. OBJECTIVES: To evaluate the clinical effectiveness and safety of topical green tea on primary pyoderma caused by S. aureus. We also attempted to determine the minimum inhibitory concentration of green tea against S...
November 14, 2017: Indian Journal of Dermatology, Venereology and Leprology
https://www.readbyqxmd.com/read/29146650/benefits-and-risks-of-iron-interventions-in-children-brisc-protocol-for-a-three-arm-parallel-group-randomised-controlled-field-trial-in-bangladesh
#9
Mohammed Imrul Hasan, Sheikh Jamal Hossain, Sabine Braat, Michael John Dibley, Jane Fisher, Sally Grantham-McGregor, Fahmida Tofail, Julie A Simpson, Shams Ei Arifeen, Jena Hamadani, Beverley-Ann Biggs, Sant-Rayn Pasricha
INTRODUCTION: Anaemia is a major global health problem affecting about 43% of preschool children globally and 60% of 6-24-month-old children in rural Bangladesh, half of which is attributed to iron deficiency (ID). Although WHO recommends universal supplementation with iron or home fortification with iron-containing multiple micronutrient powders (MMPs) to children under 2 years, evidence for benefits of these interventions on childhood development (a key rationale for these interventions) and harms (especially infection) remains limited...
November 15, 2017: BMJ Open
https://www.readbyqxmd.com/read/29146409/safety-and-effectiveness-of-long-term-treatment-with-lurasidone-in-older-adults-with-bipolar-depression-post-hoc-analysis-of-a-6-month-open-label-study
#10
Brent P Forester, Martha Sajatovic, Joyce Tsai, Andrei Pikalov, Josephine Cucchiaro, Antony Loebel
OBJECTIVE: To evaluate the safety and effectiveness of 6 months of treatment with lurasidone in older adults with a diagnosis of bipolar I depression. DESIGN: Post-hoc analysis of a multicenter, 6-month, open-label extension study. SETTING: Outpatient. PARTICIPANTS: Patients aged 55 to 75 years with a DSM-IV-TR diagnosis of bipolar I depression who had completed 6 weeks of double-blind, placebo-controlled treatment with either lurasidone monotherapy (1 study) or adjunctive therapy with lithium or valproate (2 studies)...
October 10, 2017: American Journal of Geriatric Psychiatry
https://www.readbyqxmd.com/read/29146401/neratinib-after-trastuzumab-based-adjuvant-therapy-in-her2-positive-breast-cancer-extenet-5-year-analysis-of-a-randomised-double-blind-placebo-controlled-phase-3-trial
#11
Miguel Martin, Frankie A Holmes, Bent Ejlertsen, Suzette Delaloge, Beverly Moy, Hiroji Iwata, Gunter von Minckwitz, Stephen K L Chia, Janine Mansi, Carlos H Barrios, Michael Gnant, Zorica Tomašević, Neelima Denduluri, Robert Šeparović, Erhan Gokmen, Anna Bashford, Manuel Ruiz Borrego, Sung-Bae Kim, Erik Hugger Jakobsen, Audrone Ciceniene, Kenichi Inoue, Friedrich Overkamp, Joan B Heijns, Anne C Armstrong, John S Link, Anil Abraham Joy, Richard Bryce, Alvin Wong, Susan Moran, Bin Yao, Feng Xu, Alan Auerbach, Marc Buyse, Arlene Chan
BACKGROUND: ExteNET showed that 1 year of neratinib, an irreversible pan-HER tyrosine kinase inhibitor, significantly improves 2-year invasive disease-free survival after trastuzumab-based adjuvant therapy in women with HER2-positive breast cancer. We report updated efficacy outcomes from a protocol-defined 5-year follow-up sensitivity analysis and long-term toxicity findings. METHODS: In this ongoing randomised, double-blind, placebo-controlled, phase 3 trial, eligible women aged 18 years or older (≥20 years in Japan) with stage 1-3c (modified to stage 2-3c in February, 2010) operable breast cancer, who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab with no evidence of disease recurrence or metastatic disease at study entry...
November 13, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/29146290/sustained-opioid-antagonism-modulates-striatal-sensitivity-to-baby-schema-in-opioid-use-disorder
#12
An-Li Wang, Steven B Lowen, Igor Elman, Zhenhao Shi, Victoria P Fairchild, Alexander Bouril, Ruben C Gur, Daniel D Langleben
BACKGROUND: Chronic opioid misuse is associated with reduced sensitivity to natural rewards and social motivation deficits that include impaired caregiving. The neurobiological mechanisms underlying these deficits and their response to treatment are not well understood. Baby schema (Kindchenschema) is a set of juvenile physical features, which is perceived as "cute" and triggers motivation for caregiving. Recent studies suggest that the "baby schema effect" is mediated by the brain "reward" network...
October 18, 2017: Journal of Substance Abuse Treatment
https://www.readbyqxmd.com/read/29146018/biological-treatments-in-giant-cell-arteritis-takayasu-arteritis
#13
Maxime Samson, Georgina Espígol-Frigolé, Nekane Terrades-García, Sergio Prieto-González, Marc Corbera-Bellalta, Roser Alba-Rovira, José Hernández-Rodríguez, Sylvain Audia, Bernard Bonnotte, Maria C Cid
Giant cell arteritis (GCA) and Takayasu arteritis (TAK) are the two main large vessel vasculitides. They share some similarities regarding their clinical, radiological and histological presentations but some pathogenic processes in GCA and TAK are activated differently, thus explaining their different sensitivity to biological therapies. The treatment of GCA and TAK essentially relies on glucocorticoids. However, thanks to major progress in our understanding of their pathogenesis, the role of biological therapies in the treatment of these two vasculitides is expanding, especially in relapsing or refractory diseases...
November 13, 2017: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/29145894/inositol-in-the-management-of-abdominal-aortic-aneurysm-imagen-study-protocol-for-a-randomised-controlled-trial
#14
Sophie E Rowbotham, Jenna L Pinchbeck, Georgina Anderson, Bernie Bourke, Michael Bourke, T Christian Gasser, Rene Jaeggi, Jason S Jenkins, Corey S Moran, Susan K Morton, Christopher M Reid, Ramesh Velu, Lisan Yip, Joseph V Moxon, Jonathan Golledge
BACKGROUND: An abdominal aortic aneurysm (AAA) is a focal dilation of the abdominal aorta and is associated with a risk of fatal rupture. Experimental studies suggest that myo-inositol may exert beneficial effects on AAAs through favourable changes to biological pathways implicated in AAA pathology. The aim of the Inositol in the MAnaGemENt of abdominal aortic aneurysm (IMAGEN) trial is to assess if myo-inositol will reduce AAA growth. METHODS/DESIGN: IMAGEN is a multi-centre, prospective, parallel-group, randomised, double-blind, placebo-controlled trial...
November 16, 2017: Trials
https://www.readbyqxmd.com/read/29145631/rifaximin-fails-to-prevent-campylobacteriosis-in-the-human-challenge-model-a-randomized-double-blind-placebo-controlled-trial
#15
Joanna E Rimmer, Clayton Harro, David A Sack, Kawsar R Talaat, Ramiro L Gutierrez, Barbara DeNearing, Jessica Brubaker, Renee M Laird, Frédéric Poly, Alexander C Maue, Kayla Jaep, Ashley Alcala, Yelizaveta Mochalova, Christina L Gariepy, Subhra Chakraborty, Patricia Guerry, David R Tribble, Chad K Porter, Mark S Riddle
Background: Campylobacter species are a leading cause of diarrheal disease globally with significant morbidity. Primary prevention efforts have yielded limited results. Rifaximin chemoprophylaxis decreases travelers' diarrhea rates and may be suitable for high risk persons. We assessed the efficacy of rifaximin in the controlled human infection model (CHIM) for Campylobacter jejuni. Methods: Twenty-eight subjects were admitted to an inpatient facility and randomized to a twice daily dose of 550 mg rifaximin or placebo...
November 14, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29145215/comparison-of-efficacy-and-safety-of-liraglutide-3-0-mg-in-individuals-with-bmi-above-and-below-35-kg-m%C3%A2-a-post-hoc-analysis
#16
Carel le Roux, Vanita Aroda, Joanna Hemmingsson, Ana Paula Cancino, Rune Christensen, Xavier Pi-Sunyer
OBJECTIVE: To investigate whether the efficacy and safety of liraglutide 3.0 mg differed between two subgroups, BMI 27 to <35 and BMI ≥ 35 kg/m², in individuals without and with type 2 diabetes (T2D). METHODS: A post-hoc analysis of two 56-week, randomized, double-blind, placebo-controlled trials (SCALE Obesity and Prediabetes; SCALE Diabetes). Subgroup differences in treatment effects of liraglutide 3.0 mg were evaluated by testing the interaction between treatment group and baseline BMI subgroup...
November 17, 2017: Obesity Facts
https://www.readbyqxmd.com/read/29144109/manual-therapy-rcts-should-we-control-placebo-in-placebo-control
#17
Giacomo Rossettini, Marco Testa
No abstract text is available yet for this article.
November 16, 2017: European Journal of Physical and Rehabilitation Medicine
https://www.readbyqxmd.com/read/29144061/saxagliptin-add-on-therapy-in-chinese-patients-with-type-2-diabetes-inadequately-controlled-by-insulin-with-or-without-metformin-results-from-the-super-study-a-randomized-double-blind-placebo-controlled-trial
#18
Yingli Chen, Xiaomin Liu, Quanmin Li, Jianhua Ma, Xiaofeng Lv, Lixin Guo, Changjiang Wang, Yongquan Shi, Yanbing Li, Eva Johnsson, Mei Wang, June Zhao, Linong Ji
This prospective, multicentre, phase 3 study (NCT02104804) evaluated the efficacy and safety of saxagliptin add-on therapy in Chinese patients with type 2 diabetes inadequately controlled by insulin ± metformin. Patients with glycated haemoglobin (HbA1c) 7.5%-10.5% and fasting plasma glucose (FPG) <270 mg/dL on stable insulin therapy (20-150 U/day) were randomized (1:1) to saxagliptin 5 mg once daily (N = 232) or placebo (N = 230) for 24 weeks, stratified by metformin use. The primary efficacy measure was change in HbA1c...
November 16, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29143869/peripheral-endocannabinoid-concentrations-are-not-associated-with-verbal-memory-impairment-during-mdma-intoxication
#19
E Haijen, M Farre, R de la Torre, A Pastor, E Olesti, N Pizarro, J G Ramaekers, K P C Kuypers
BACKGROUND: Preclinical data have suggested involvement of the endocannabinoid (eCB) system in MDMA-induced memory impairment. Clinical research has shown that blockade of the 5-HT2 receptor nulls memory impairment during MDMA intoxication. Interestingly, studies have demonstrated that the eCB and the 5-HT system interact. It was hypothesized that MDMA would cause an increase in eCB concentrations together with a decrease in memory performance, and that combining MDMA with a 5-HT2 receptor blocker ketanserin would lead to a counteraction of the MDMA effects on eCB concentrations and memory...
November 16, 2017: Psychopharmacology
https://www.readbyqxmd.com/read/29143707/effect-of-multi-micronutrient-fortified-rice-on-cognitive-performance-depends-on-premix-composition-and-cognitive-function-tested-results-of-an-effectiveness-study-in-cambodian-schoolchildren
#20
Marion Fiorentino, Marlène Perignon, Khuov Kuong, Richard de Groot, Megan Parker, Kurt Burja, Marjoleine A Dijkhuizen, Sek Sokhom, Chhoun Chamnan, Jacques Berger, Frank T Wieringa
OBJECTIVE: Even though current policy is strongly focused on the crucial first '1000 days', it might be still possible to enhance cognitive function during the pre-adolescent and adolescent years by improving micronutrient status. In Cambodia, nutritional status is poor. Provision of rice fortified with micronutrients through a school meal programme (SMP) could be a cost-effective strategy to help improve health and school performance. The present study aimed to evaluate the effect of three different micronutrient-fortified rice formulations on cognitive function in Cambodian children...
November 16, 2017: Public Health Nutrition
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