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https://www.readbyqxmd.com/read/28538644/validation-of-a-clinical-trial-composite-endpoint-for-patients-with-necrotizing-soft-tissue-infections
#1
Eileen M Bulger, Addison May, Wayne Dankner, Greg Maislin, Bryce Robinson, Anat Shirvan
OBJECTIVE: Our objective was to develop and validate a composite endpoint for patients with necrotizing soft tissue infections (NSTI) that incorporates: local tissue injury, systemic organ dysfunction, and mortality. METHODS: The Necrotizing Infection Clinical Composite Endpoint (NICCE) was defined as follows:(i) Alive at day 28 (ii) ≤3 debridements prior to day 14 (iii) No amputation beyond first debridement (iv) Modified SOFA score (mSOFA) at day 14 ≤1. To be considered a success, all individual criteria must be met...
May 22, 2017: Journal of Trauma and Acute Care Surgery
https://www.readbyqxmd.com/read/28538404/pregabalin-can-decrease-acute-pain-and-morphine-consumption-in-laparoscopic-cholecystectomy-patients-a-meta-analysis-of-randomized-controlled-trials
#2
Shijie Li, Junqiang Guo, Fangjun Li, Zhijia Yang, Shuai Wang, Changjiang Qin
BACKGROUND: Pregabalin has been used as an adjunct for the management of acute pain in laparoscopic cholecystectomy. This meta-analysis aimed to illustrate the efficacy and safety of pregabalin for pain management following laparoscopic cholecystectomy. METHODS: In March 2017, a systematic computer-based search was conducted in PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, and Google databases. Data on patients prepared for laparoscopic cholecystectomy in studies that compared pregabalin versus placebo were retrieved...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28538380/acute-effects-of-cinacalcet-on-arterial-stiffness-and-ventricular-function-in-hemodialysis-patients-a-randomized-double-blinded-crossover-study
#3
Aurélie Poulin, Pierre-Luc Bellemare, Catherine Fortier, Fabrice Mac-Way, Simon Desmeules, Karine Marquis, Valérie Gaudreault, Marcel Lebel, Mohsen Agharazii
BACKGROUND: Serum calcium concentration (Ca) plays an essential role in a vascular muscle tone and myocardial contractility. Previously, we showed that acutely lowering Ca by hemodialysis reduced arterial stiffness. Cinacalcet is a calcimimetic that lowers Ca and parathyroid hormone (PTH). The aim of the present study was to examine whether acute lowering of Ca by cinacalcet improves vascular stiffness and myocardial diastolic dysfunction. METHOD: This is a double-blinded randomized placebo-controlled crossover study that included 21 adult patients with end-stage kidney disease undergoing chronic hemodialysis...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28538366/preventing-necrotizing-enterocolitis-by-food-additives-in-neonates-a-network-meta-analysis-revealing-the-efficacy-and-safety
#4
Wentao Yu, Wu Sui, Linsong Mu, Wenying Yi, Haijuan Li, Liqin Wei, Weihong Yin
BACKGROUND: Necrotizing enterocolitis (NEC) is a serious multifactorial gastrointestinal disease which is often discovered in premature infants. Various additives have been used to prevent NEC; yet, their relative efficacy and safety remain disputed. This study aims to compare the efficacy and safety of 5 food additives, namely, probiotics, probiotics + fructo-oligosaccharides, pentoxifylline, arginine, and lactoferrin in preventing NEC in neonates. METHODS: Embase, PubMed, and Cochrane Library had been searched for all eligible randomized control trials...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28538134/trial-of-cannabidiol-for-drug-resistant-seizures-in-the-dravet-syndrome
#5
Orrin Devinsky, J Helen Cross, Linda Laux, Eric Marsh, Ian Miller, Rima Nabbout, Ingrid E Scheffer, Elizabeth A Thiele, Stephen Wright
BACKGROUND: The Dravet syndrome is a complex childhood epilepsy disorder that is associated with drug-resistant seizures and a high mortality rate. We studied cannabidiol for the treatment of drug-resistant seizures in the Dravet syndrome. METHODS: In this double-blind, placebo-controlled trial, we randomly assigned 120 children and young adults with the Dravet syndrome and drug-resistant seizures to receive either cannabidiol oral solution at a dose of 20 mg per kilogram of body weight per day or placebo, in addition to standard antiepileptic treatment...
May 25, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28538111/cardiovascular-and-metabolic-effects-of-angptl3-antisense-oligonucleotides
#6
Mark J Graham, Richard G Lee, Teresa A Brandt, Li-Jung Tai, Wuxia Fu, Raechel Peralta, Rosie Yu, Eunju Hurh, Erika Paz, Bradley W McEvoy, Brenda F Baker, Nguyen C Pham, Andres Digenio, Steven G Hughes, Richard S Geary, Joseph L Witztum, Rosanne M Crooke, Sotirios Tsimikas
Background Epidemiologic and genomewide association studies have linked loss-of-function variants in ANGPTL3, encoding angiopoietin-like 3, with low levels of plasma lipoproteins. Methods We evaluated antisense oligonucleotides (ASOs) targeting Angptl3 messenger RNA (mRNA) for effects on plasma lipid levels, triglyceride clearance, liver triglyceride content, insulin sensitivity, and atherosclerosis in mice. Subsequently, 44 human participants (with triglyceride levels of either 90 to 150 mg per deciliter [1...
May 24, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28538088/effects-of-the-insulin-sensitizer-metformin-in-alzheimer-disease-pilot-data-from-a-randomized-placebo-controlled-crossover-study
#7
Aaron M Koenig, Dawn Mechanic-Hamilton, Sharon X Xie, Martha F Combs, Anne R Cappola, Long Xie, John A Detre, David A Wolk, Steven E Arnold
Epidemiological studies have identified a robust association between type II diabetes mellitus and Alzheimer disease (AD), and neurobiological studies have suggested the presence of central nervous system insulin resistance in individuals with AD. Given this association, we hypothesized that the central nervous system-penetrant insulin-sensitizing medication metformin would be beneficial as a disease-modifying and/or symptomatic therapy for AD, and conducted a placebo-controlled crossover study of its effects on cerebrospinal fluid (CSF), neuroimaging, and cognitive biomarkers...
April 2017: Alzheimer Disease and Associated Disorders
https://www.readbyqxmd.com/read/28538024/effects-of-vilazodone-on-suicidal-ideation-and-behavior-in-adults-with-major-depressive-disorder-or-generalized-anxiety-disorder-post-hoc-analysis-of-randomized-double-blind-placebo-controlled-trials
#8
Michael E Thase, John Edwards, Suresh Durgam, Changzheng Chen, Cheng-Tao Chang, Maju Mathews, Carl P Gommoll
Treatment-emergent suicidal ideation and behavior are ongoing concerns with antidepressants. Vilazodone, currently approved for the treatment of major depressive disorder (MDD) in adults, has also been evaluated in generalized anxiety disorder (GAD). Post-hoc analyses of vilazodone trials were carried out to examine its effects on suicidal ideation and behavior in adults with MDD or GAD. Data were pooled from vilazodone trials in MDD (four studies) and GAD (three studies). The incidence of suicide-related events was analyzed on the basis of treatment-emergent adverse event reporting and Columbia-Suicide Severity Rating Scale (C-SSRS) monitoring...
May 19, 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/28537982/selective-cannabinoids-for-chronic-neuropathic-pain-a-systematic-review-and-meta-analysis
#9
Howard Meng, Bradley Johnston, Marina Englesakis, Dwight E Moulin, Anuj Bhatia
BACKGROUND: There is a lack of consensus on the role of selective cannabinoids for the treatment of neuropathic pain (NP). Guidelines from national and international pain societies have provided contradictory recommendations. The primary objective of this systematic review and meta-analysis (SR-MA) was to determine the analgesic efficacy and safety of selective cannabinoids compared to conventional management or placebo for chronic NP. METHODS: We reviewed randomized controlled trials that compared selective cannabinoids (dronabinol, nabilone, nabiximols) with conventional treatments (eg, pharmacotherapy, physical therapy, or a combination of these) or placebo in patients with chronic NP because patients with NP may be on any of these therapies or none if all standard treatments have failed to provide analgesia and or if these treatments have been associated with adverse effects...
May 19, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28537969/thoracic-epidural-analgesia-with-levobupivacaine-reduces-remifentanil-and-propofol-consumption-evaluated-by-closed-loop-titration-guided-by-the-bispectral-index-a-double-blind-placebo-controlled-study
#10
Virginie Dumans-Nizard, Morgan Le Guen, Edouard Sage, Thierry Chazot, Marc Fischler, Ngai Liu
BACKGROUND: Thoracic epidural analgesia (TEA) combined with general anesthesia decreases anesthetic requirements by half when hemodynamic criteria are used for the titration of analgesia. We therefore determined the impact of TEA on anesthetic requirements, when a closed-loop controller was used allowing the automated coadministration of propofol-remifentanil guided solely by the Bispectral index. METHODS: This single-center double-blind study enrolled patients scheduled for elective posterolateral thoracotomy using TEA...
May 19, 2017: Anesthesia and Analgesia
https://www.readbyqxmd.com/read/28535619/prevalence-and-incidence-of-osteoporotic-fractures-in-patients-on-long-term-glucocorticoid-treatment-for-rheumatic-diseases-the-glucocorticoid-induced-osteoporosis-tool-giotto-study
#11
M Rossini, O Viapiana, M Vitiello, N Malavolta, G La Montagna, S Maddali Bongi, O Di Munno, R Nuti, C U Manzini, C Ferri, L Bogliolo, A Mathieu, F Cantatore, A Del Puente, M Muratore, W Grassi, B Frediani, G Saviola, P Delvino, L Mirone, G Ferraccioli, G Tripi, I Piazza, D Gatti
Osteoporosis and fractures are common and invalidating consequences of chronic glucorticoid (GC) treatment. Reliable information regarding the epidemiology of GC induced osteoporosis (GIOP) comes exclusively from the placebo group of randomized clinical trials while observational studies are generally lacking data on the real prevalence of vertebral fractures, GC dosage and primary diagnosis. The objective of this study was to evaluate the prevalence and incidence of osteoporotic fractures and to identify their major determinants (primary disease, GC dosage, bone mineral density, risk factors, specific treatment for GIOP) in a large cohort of consecutive patients aged >21 years, on chronic treatment with GC (≥5 mg prednisone - PN - equivalent) and attending rheumatology centers located all over Italy...
May 22, 2017: Reumatismo
https://www.readbyqxmd.com/read/28535547/the-effectiveness-of-manual-therapy-for-relieving-pain-stiffness-and-dysfunction-in-knee-osteoarthritis-a-systematic-review-and-meta-analysis
#12
Qinguang Xu, Bei Chen, Yueyi Wang, Xuezong Wang, Dapeng Han, Daofang Ding, Yuxin Zheng, Yuelong Cao, Hongsheng Zhan, Yao Zhou
BACKGROUND: Knee osteoarthritis (KOA) is the most common form of arthritis, leading to pain disability in seniors and increased health care utilization. Manual therapy is one widely used physical treatment for KOA. OBJECTIVE: To evaluate the effectiveness and adverse events (AEs) of manual therapy compared to other treatments for relieving pain, stiffness, and physical dysfunction in patients with KOA. STUDY DESIGN: A systematic review and meta-analysis of manual therapy for KOA...
May 2017: Pain Physician
https://www.readbyqxmd.com/read/28535237/effect-of-intravenous-ferric-carboxymaltose-on-hemoglobin-response-among-patients-with-acute-isovolemic-anemia-following-gastrectomy-the-fairy-randomized-clinical-trial
#13
Young-Woo Kim, Jae-Moon Bae, Young-Kyu Park, Han-Kwang Yang, Wansik Yu, Jeong Hwan Yook, Sung Hoon Noh, Mira Han, Keun Won Ryu, Tae Sung Sohn, Hyuk-Joon Lee, Oh Kyoung Kwon, Seung Yeob Ryu, Jun-Ho Lee, Sung Kim, Hong Man Yoon, Bang Wool Eom, Min-Gew Choi, Beom Su Kim, Oh Jeong, Yun-Suhk Suh, Moon-Won Yoo, In Seob Lee, Mi Ran Jung, Ji Yeong An, Hyoung-Il Kim, Youngsook Kim, Hannah Yang, Byung-Ho Nam
Importance: Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. Objective: To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. Design, Setting, and Participants: The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea...
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28535235/effect-of-cephalexin-plus-trimethoprim-sulfamethoxazole-vs-cephalexin-alone-on-clinical-cure-of-uncomplicated-cellulitis-a-randomized-clinical-trial
#14
Gregory J Moran, Anusha Krishnadasan, William R Mower, Fredrick M Abrahamian, Frank LoVecchio, Mark T Steele, Richard E Rothman, David J Karras, Rebecca Hoagland, Stephanie Pettibone, David A Talan
Importance: Emergency department visits for skin infections in the United States have increased with the emergence of methicillin-resistant Staphylococcus aureus (MRSA). For cellulitis without purulent drainage, β-hemolytic streptococci are presumed to be the predominant pathogens. It is unknown if antimicrobial regimens possessing in vitro MRSA activity provide improved outcomes compared with treatments lacking MRSA activity. Objective: To determine whether cephalexin plus trimethoprim-sulfamethoxazole yields a higher clinical cure rate of uncomplicated cellulitis than cephalexin alone...
May 23, 2017: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/28535076/intraarticular-injection-of-a-cross-linked-sodium-hyaluronate-combined-with-triamcinolone-hexacetonide-cingal-to-provide-symptomatic-relief-of-osteoarthritis-of-the-knee-a-randomized-double-blind-placebo-controlled-multicenter-clinical-trial
#15
Laszlo Hangody, Robert Szody, Piotr Lukasik, Wojciech Zgadzaj, Endre Lénárt, Eva Dokoupilova, Daniela Bichovsk, Agnes Berta, Gabor Vasarhelyi, Andrea Ficzere, György Hangody, Gary Stevens, Miklos Szendroi
OBJECTIVE: To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis. DESIGN: This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0...
May 1, 2017: Cartilage
https://www.readbyqxmd.com/read/28534875/dose-dependent-social-cognitive-effects-of-intranasal-oxytocin-delivered-with-novel-breath-powered-device-in-adults-with-autism-spectrum-disorder-a-randomized-placebo-controlled-double-blind-crossover-trial
#16
D S Quintana, L T Westlye, S Hope, T Nærland, T Elvsåshagen, E Dørum, Ø Rustan, M Valstad, L Rezvaya, H Lishaugen, E Stensønes, S Yaqub, K T Smerud, R A Mahmoud, P G Djupesland, O A Andreassen
The neuropeptide oxytocin has shown promise as a treatment for symptoms of autism spectrum disorders (ASD). However, clinical research progress has been hampered by a poor understanding of oxytocin's dose-response and sub-optimal intranasal delivery methods. We examined two doses of oxytocin delivered using a novel Breath Powered intranasal delivery device designed to improve direct nose-to-brain activity in a double-blind, crossover, randomized, placebo-controlled trial. In a randomized sequence of single-dose sessions, 17 male adults with ASD received 8 international units (IU) oxytocin, 24IU oxytocin or placebo followed by four social-cognitive tasks...
May 23, 2017: Translational Psychiatry
https://www.readbyqxmd.com/read/28534028/mechanisms-affecting-the-gut-of-preterm-infants-in-enteral-feeding-trials
#17
Nicholas D Embleton, Janet E Berrington, Jon Dorling, Andrew K Ewer, Edmund Juszczak, John A Kirby, Christopher A Lamb, Clare V Lanyon, William McGuire, Christopher S Probert, Stephen P Rushton, Mark D Shirley, Christopher J Stewart, Stephen P Cummings
Large randomized controlled trials (RCTs) in preterm infants offer unique opportunities for mechanistic evaluation of the risk factors leading to serious diseases, as well as the actions of interventions designed to prevent them. Necrotizing enterocolitis (NEC) a serious inflammatory gut condition and late-onset sepsis (LOS) are common feeding and nutrition-related problems that may cause death or serious long-term morbidity and are key outcomes in two current UK National Institutes for Health Research (NIHR) trials...
2017: Frontiers in Nutrition
https://www.readbyqxmd.com/read/28534014/primiparous-singleton-women-with-endometriosis-have-an-increased-risk-of-preterm-birth-meta-analyses
#18
Sun-Gyeong Kim, Hui-Gyeong Seo, Yun-Sook Kim
OBJECTIVE: The objective of this study was to assess the association between women with endometriosis and risk of preterm birth. METHODS: Two reviewers independently determined all prospective cohort study, retrospective cohort study, large population based cohort study, retrospective secondary analysis, and double blinded, multicentric, observational and cohort study, placebo-controlled, randomized clinical trial published using PubMed, Medline, Korea Education and Research Information Service, and Scopus from March 1994 through February 2016 without language restrictions comparing obstetric outcomes women with endometriosis and women without endometriosis...
May 2017: Obstetrics & Gynecology Science
https://www.readbyqxmd.com/read/28533925/low-dose-oral-curcumin-is-not-effective-in-induction-of-remission-in-mild-to-moderate-ulcerative-colitis-results-from-a-randomized-double-blind-placebo-controlled-trial
#19
Saurabh Kedia, Vikram Bhatia, Sandeep Thareja, Sushil Garg, Venigalla Pratap Mouli, Sawan Bopanna, Veena Tiwari, Govind Makharia, Vineet Ahuja
AIM: To evaluate the role of oral curcumin in inducing clinical remission in patients with mild to moderate ulcerative colitis (UC). METHODS: A prospective randomized double-blind placebo-controlled trial comparing the remission inducing effect of oral curcumin and mesalamine 2.4 g with placebo and mesalamine 2.4 g in patients of ulcerative colitis with mild to moderate severity was conducted from January 2003 to March 2005. The included patients received 1 capsule thrice a day of placebo or curcumin (150 mg) for 8 wk...
May 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28533916/pediatric-intensive-care-stress-ulcer-prevention-pic-up-a-protocol-for-a-pilot-randomized-trial
#20
Mark Duffett, Karen Choong, Jennifer Foster, Elaine Gilfoyle, Jacques Lacroix, Nikhil Pai, Lehana Thabane, Deborah J Cook
BACKGROUND: Despite sparse pediatric data on effectiveness, the majority of critically ill children receive medications to prevent gastrointestinal (GI) bleeding. Stress ulcer prophylaxis may have unintended consequences-increasing the risk of nosocomial infections-which may be more serious and common than the bleeding which these drugs are prescribed to prevent. Randomized controlled trials (RCTs) in pediatric critical care are exceptionally challenging to complete, thus a rigorous pilot RCT is crucial...
2017: Pilot and Feasibility Studies
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