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https://www.readbyqxmd.com/read/27936355/sample-size-determination-for-a-three-arm-equivalence-trial-of-poisson-and-negative-binomial-responses
#1
Yu-Wei Chang, Yi Tsong, Zhigen Zhao
Assessing equivalence or similarity has drawn much attention recently as many drug products have lost or will lose their patents in the next few years, especially certain best-selling biologics. To claim equivalence between the test treatment and the reference treatment when assay sensitivity is well-established from historical data, one has to demonstrate both superiority of the test treatment over placebo and equivalence between the test treatment and the reference treatment. Thus, there is urgency for practitioners to derive a practical way to calculate sample size for a three-arm equivalence trial...
December 9, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27936352/prescott-tests-of-equality-in-binary-data-under-a-three-treatment-three-perod-crossover-design
#2
Lixia Zhu, Kung-Jong Lui
Three test procedures accounting for patients with tied responses based on Prescott's ideas are developed for comparing three treatments under a three-period crossover trial in binary data. Monte Carlo simulation is employed to evaluate the performance of these test procedures in a variety of situations. The test procedures proposed here are noted to have power larger than those procedures, which utilize only those patients with un-tied responses. The data taken from a three-period crossover trial comparing two different doses of an analgesic with placebo for the relief of primary dysmenorrhea are used to illustrate the use of the test procedures developed here...
December 9, 2016: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/27935521/leucine-supplementation-enhances-integrative-myofibrillar-protein-synthesis-in-free-living-older-men-consuming-lower-and-higher-protein-diets-a-parallel-group-crossover-study
#3
Caoileann H Murphy, Nelson I Saddler, Michaela C Devries, Chris McGlory, Steven K Baker, Stuart M Phillips
BACKGROUND: Leucine co-ingestion with lower-protein (LP)-containing meals may overcome the blunted muscle protein synthetic response to food intake in the elderly but may be effective only in individuals who consume LP diets. OBJECTIVE: We examined the impact of leucine co-ingestion with mixed macronutrient meals on integrated 3-d rates of myofibrillar protein synthesis (MyoPS) in free-living older men who consumed higher protein (HP) (1.2 g · kg(-1) · d(-1)) or LP (0...
December 2016: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/27933509/effect-of-shuanghu-qinggan-granule-and-yigan-yiqi-jieyu-granule-plus-lamivudine-on-chronic-hepatitis-b-patients-a-randomized-double-blind-placebo-controlled-trial
#4
Yong-An Ye, De-Lu Tian, Jian Jiang, Jun Li, Jian-Jie Chen, Zhi-Hong Li, Wei-Guo Ma, Yi-Ming Zhao, Rong-Bing Wang, Shi-Zhong Yang, Feng-Zhen Shao, Guang Ji, Da-Qiao Zhou, Tie-Jun Liu, Dong-Sheng Cheng, Wei Zhang, Ke-Wei Sun, Yu-Fen Wang, Le-Quan Min, Xiao-Ke Li
OBJECTIVE: To observe the clinical efficacy and safety of Shuanghu Qinggan Granule ( , SQG) plus Yigan Yiqi Jieyu Granule (, YYJG) combined with lamivudine (LAM) on chronic hepatitis B (CHB) patients. METHODS: The study was a multicenter, randomized, double-blinded and parallel controlled trial. A total of 320 patients were randomly allocated into 2 groups equally: 160 patients (treatment group) were given SQG and YYJG combined with LAM; and 160 patients (control group) were given LAM plus Chinese herb placebo, respectively...
December 8, 2016: Chinese Journal of Integrative Medicine
https://www.readbyqxmd.com/read/27933199/efficacy-and-tolerability-of-repository-corticotropin-injection-in-patients-with-persistently-active-sle-results-of-a-phase-4-randomised-controlled-pilot-study
#5
Richard Furie, Margaret Mitrane, Enxu Zhao, Maya Das, Daner Li, Patrice M Becker
OBJECTIVE: To evaluate the efficacy of a prolonged-release formulation of a porcine adrenocorticotropic hormone analogue (repository corticotropin injection (RCI)) added to standard of care in patients requiring moderate-dose corticosteroids for symptomatic SLE. METHODS: This prospective, randomised, double-blind, phase 4, pilot study (NCT01753401) enrolled 38 patients with persistently active SLE involving skin and/or joints. Enrolled patients received RCI, 40 U daily or 80 U every other day, or volume-matched placebo gel, for 8 weeks, with dose tapering to twice weekly during weeks 5-8...
2016: Lupus Science & Medicine
https://www.readbyqxmd.com/read/27932864/efficacy-and-tolerability-of-vilazodone-for-major-depressive-disorder-evidence-from-phase-iii-iv-randomized-controlled-trials
#6
Ligen Shi, Jingyi Wang, Shenbin Xu, Yunrong Lu
Vilazodone is a new molecule approved for major depressive disorder (MDD). This report focuses on the efficacy and tolerability of vilazodone for MDD. MEDLINE, EMBASE, and Cochrane Library were searched. A total of 1,930 patients from four trials were included. A significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score was seen as early as week 2 (P<0.01) in vilazodone-treated patients. The results showed a higher rate of MADRS response with vilazodone compared with placebo (P<0...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27932792/responses-to-pomalidomide-and-placebo-in-myelofibrosis-related-anaemia
#7
D M Ross
No abstract text is available yet for this article.
December 9, 2016: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/27932229/regorafenib-for-patients-with-hepatocellular-carcinoma-who-progressed-on-sorafenib-treatment-resorce-a-randomised-double-blind-placebo-controlled-phase-3-trial
#8
Jordi Bruix, Shukui Qin, Philippe Merle, Alessandro Granito, Yi-Hsiang Huang, György Bodoky, Marc Pracht, Osamu Yokosuka, Olivier Rosmorduc, Valeriy Breder, René Gerolami, Gianluca Masi, Paul J Ross, Tianqiang Song, Jean-Pierre Bronowicki, Isabelle Ollivier-Hourmand, Masatoshi Kudo, Ann-Lii Cheng, Josep M Llovet, Richard S Finn, Marie-Aude LeBerre, Annette Baumhauer, Gerold Meinhardt, Guohong Han
BACKGROUND: There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment. METHODS: In this randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults with HCC who tolerated sorafenib (≥400 mg/day for ≥20 of last 28 days of treatment), progressed on sorafenib, and had Child-Pugh A liver function were enrolled...
December 5, 2016: Lancet
https://www.readbyqxmd.com/read/27931887/medial-prefrontal-cortex-stimulation-accelerates-therapy-response-of-exposure-therapy-in-acrophobia
#9
Martin J Herrmann, Andrea Katzorke, Yasmin Busch, Daniel Gromer, Thomas Polak, Paul Pauli, Jürgen Deckert
BACKGROUND: Animal as well as human research indicated that the ventral medial prefrontal cortex (vmPFC) is highly relevant for fear extinction learning. Recently, we showed that targeting the vmPFC with high-frequency repetitive transcranial magnetic stimulation (rTMS) in a placebo-controlled study with 45 healthy controls induced higher prefrontal activity during extinction of conditioned stimuli (CS+) in the active compared to the sham stimulated group and better extinction learning as indicated by ratings, fear potentiated startles and skin conductance responses...
November 14, 2016: Brain Stimulation
https://www.readbyqxmd.com/read/27931302/new-insights-into-treatment-of-children-with-exercise-induced-asthma-symptoms
#10
Iwona Stelmach, Anna Sztafiska, Joanna Jerzyska, Daniela Podlecka, Pawe Majak, Wodzimierz Stelmach
BACKGROUND: Exercise is one of the most common triggers of bronchoconstriction and affects up to 80% of children with asthma. OBJECTIVE: The purpose of this randomized, double-blind, placebo-controlled study was to assess the effectiveness of treatment with ciclesonide 160 microgram, either alone, with a higher dose, with a leukotriene receptor antagonist (LTRA), or with a long-acting beta-agonist (LABA) in children with asthma with postexercise-induced symptoms...
November 2016: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/27931259/abdominal-septic-shock-endotoxin-adsorption-treatment-asset-endotoxin-removal-in-abdominal-and-urogenital-septic-shock-with-the-alteco%C3%A2-lps-adsorber-study-protocol-for-a-double-blinded-randomized-placebo-controlled-trial
#11
Miklos Lipcsey, Jyrki Tenhunen, Jan Sjölin, Robert Frithiof, Stepani Bendel, Hans Flaatten, Rafael Kawati, Anne Kuitunen, Tor Inge Tønnessen, Sten Rubertsson
BACKGROUND: Severe sepsis and septic shock are common in intensive care and carry high mortality rates. In patients with Gram-negative infections, early and extensive removal of endotoxin may limit the inflammatory response that characterizes septic shock. The Alteco® LPS Adsorber (hereafter referred to cited as the lipopolysaccharide (LPS) Adsorber) can be used for endotoxin removal and attenuate the deleterious inflammatory and clinical responses seen in septic shock. METHODS/DESIGN: The Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) trial is a pilot study investigating the feasibility and safety of LPS Adsorber therapy...
December 8, 2016: Trials
https://www.readbyqxmd.com/read/27931077/antibiotics-for-the-neurological-complications-of-lyme-disease
#12
REVIEW
Diego Cadavid, Paul G Auwaerter, Jeffrey Rumbaugh, Harald Gelderblom
BACKGROUND: Various central nervous system-penetrant antibiotics are bactericidal in vitro and in vivo against the causative agent of Lyme neuroborreliosis (LNB), Borrelia burgdorferi. These antibiotics are routinely used clinically to treat LNB, but their relative efficacy is not clear. OBJECTIVES: To assess the effects of antibiotics for the treatment of LNB. SEARCH METHODS: On 25 October 2016 we searched the Cochrane Neuromuscular Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase...
December 9, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27930706/do-reported-effects-of-acute-aerobic-exercise-on-subsequent-higher-cognitive-performances-remain-if-tested-against-an-instructed-self-myofascial-release-training-control-group-a-randomized-controlled-trial
#13
Max Oberste, Wilhelm Bloch, Sven T Hübner, Philipp Zimmer
A substantial body of evidence suggests positive effects of acute aerobic exercise (AAE) on subsequent higher cognitive functions in healthy young adults. These effects are widely understood as a result of the ongoing physiological adaptation processes induced by the preceding AAE. However, designs of published studies do not control for placebo, Hawthorne and subject expectancy effects. Therefore, these studies do not, at a high degree of validity, allow attributing effects of AEE on subsequent cognitive performance to exercise induced physical arousal...
2016: PloS One
https://www.readbyqxmd.com/read/27930578/short-term-and-long-term-efficacy-of-7-targeted-therapies-for-the-treatment-of-advanced-hepatocellular-carcinoma-a-network-meta-analysis-efficacy-of-7-targeted-therapies-for-ahcc
#14
Meng Niu, Duo Hong, Teng-Chuang Ma, Xiao-Wei Chen, Jin-Hang Han, Jun Sun, Ke Xu
BACKGROUND: A variety of targeted drug therapies in clinical trials have been proven to be effective for the treatment of hepatocellular carcinoma (HCC). Our study aims to compare the short-term and long-term efficacies of different targeted drugs in advanced hepatocellular carcinoma (AHCC) treatment using a network meta-analysis approach. METHODS: PubMed, Embase, Ovid, EBSCO, and Cochrane central register of controlled trials were searched for randomized controlled trials (RCTs) of different targeted therapies implemented to patients with AHCC...
December 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27930500/effect-of-rivastigmine-augmentation-in-treatment-of-male-patients-with-combat-related-chronic-posttraumatic-stress-disorder-a-randomized-controlled-trial
#15
Amir Rezaei Ardani, Golkoo Hosseini, Mohammad Reza Fayyazi Bordbar, Ali Talaei, Hesam Mostafavi Toroghi
BACKGROUND: Posttraumatic stress disorder (PTSD) is one of the chronic and disabling psychiatric disorders, particularly in combat veterans. In a case series, rivastigmine was suggested to be an effective augmentation in treatment of PTSD. The aim of the present study was to evaluate this finding in a randomized controlled trial. METHOD: A 12-week, double-blind, placebo-controlled clinical trial was performed on 36 male patients (aged 42-60 years) diagnosed with chronic, combat-related PTSD...
December 7, 2016: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/27930497/the-comt-val158met-polymorphism-is-associated-with-response-to-add-on-dextromethorphan-treatment-in-bipolar-disorder
#16
Sheng-Yu Lee, Shiou-Lan Chen, Tzu-Yun Wang, Yun-Hsuan Chang, Po See Chen, San-Yuan Huang, Nian-Sheng Tzeng, Liang-Jen Wang, I Hui Lee, Kao Ching Chen, Yen Kuang Yang, Ru-Band Lu
PURPOSE/BACKGROUND: We previously conducted a randomized, double-blind, controlled, 12-week study evaluating the effect of add-on dextromethorphan (DM), a noncompetitive N-methyl-D-aspartate receptor antagonist, on patients with bipolar disorder (BD) treated using valproate (VPA), which showed negative clinical differences. The genetic variation between each individual may be responsible for interindividual differences. The catechol-O-methyltransferase (COMT) gene has been a candidate gene for BD...
December 7, 2016: Journal of Clinical Psychopharmacology
https://www.readbyqxmd.com/read/27930408/vedolizumab-as-induction-and-maintenance-therapy-for-crohn-s-disease-in-patients-na%C3%A3-ve-to-or-who-have-failed-tumor-necrosis-factor-antagonist-therapy
#17
Bruce E Sands, William J Sandborn, Gert Van Assche, Milan Lukas, Jing Xu, Alexandra James, Brihad Abhyankar, Karen Lasch
BACKGROUND: Vedolizumab is a gut-selective α4β7 integrin antagonist for the treatment of moderately to severely active Crohn's disease (CD). Aims of this study were to characterize the efficacy and safety of vedolizumab induction and maintenance therapy in patients who were naïve to tumor necrosis factor-alpha (TNF-α) antagonist therapy (TNF-naïve) or who had discontinued TNF-α antagonist therapy because of inadequate response (i.e., primary nonresponse), loss of response, or intolerance (collectively classified as the TNF-failure population)...
December 7, 2016: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/27929203/real-time-dose-adjustment-using-point-of-care-platelet-reactivity-testing-in-a-double-blind-study-of-prasugrel-in-children-with-sickle-cell-anaemia
#18
Joseph A Jakubowski, Carolyn C Hoppe, Chunmei Zhou, Brendan E Smith, Patricia B Brown, Lori E Heath, Baba Inusa, David C Rees, David S Small, Neehar Gupta, Suqin Yao, Matthew Heeney, Julie Kanter
Patients with sickle cell anaemia (SCA) have vaso-occlusive crises resulting from occlusive hypoxic-ischaemic injury. Prasugrel inhibits platelet activation and aggregation involved in SCA pathophysiology. Determining Effects of Platelet Inhibition on Vaso-Occlusive Events (DOVE) was a phase 3, double-blind, randomised, placebo-controlled trial assessing prasugrel efficacy. DOVE sought to bring patients' P2Y12 reaction unit (PRU) value within a targeted range via prasugrel dose adjustments using encrypted VerifyNow P2Y12(®) (VN-P2Y12) point-of-care testing and an interactive voice-response system (IVRS)...
December 8, 2016: Thrombosis and Haemostasis
https://www.readbyqxmd.com/read/27929185/melatonin-and-hydroxytyrosol-protect-against-oxidative-stress-related-to-the-central-nervous-system-after-the-ingestion-of-three-types-of-wine-by-healthy-volunteers
#19
Javier Marhuenda, Sonia Medina, Pedro Martínez-Hernández, Simón Arina, Pilar Zafrilla, Juana Mulero, Camille Oger, Jean-Marie Galano, Thierry Durand, Federico Ferreres, Angel Gil-Izquierdo
Adrenic acid (AdA) and docosahexaenoic acid (DHA) peroxidation produces F2-dihomo-IsoPs and neuroprostanes, which have been related to oxidative damage in the central nervous system. Besides polyphenols, melatonin (MEL) and hydroxytyrosol (OHTyr) could be partly responsible for the antioxidant benefits of red wine (excluding colon derivatives). In order to elucidate whether these compounds are responsible for the protective antioxidant effects of red wine, a double-blind, crossover, placebo-controlled in vivo study - involving the intake of red wines and their native musts by healthy volunteers - was performed...
December 8, 2016: Food & Function
https://www.readbyqxmd.com/read/27928721/clinical-and-metabolic-response-to-selenium-supplementation-in-pregnant-women-at-risk-for-intrauterine-growth-restriction-randomized-double-blind-placebo-controlled-trial
#20
Elaheh Mesdaghinia, Azam Rahavi, Fereshteh Bahmani, Nasrin Sharifi, Zatollah Asemi
Data on the effects of selenium supplementation on clinical signs and metabolic profiles in women at risk for intrauterine growth restriction (IUGR) are scarce. This study was designed to assess the effects of selenium supplementation on clinical signs and metabolic status in pregnant women at risk for IUGR. This randomized double-blind placebo-controlled clinical trial was performed among 60 women at risk for IUGR according to abnormal uterine artery Doppler waveform. Participants were randomly assigned to intake either 100 μg selenium supplements as tablet (n = 30) or placebo (n = 30) for 10 weeks between 17 and 27 weeks of gestation...
December 7, 2016: Biological Trace Element Research
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