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Enriched trial design

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https://www.readbyqxmd.com/read/28157671/can-wheat-germ-have-a-beneficial-effect-on-human-health-a-study-protocol-for-a-randomised-crossover-controlled-trial-to-evaluate-its-health-effects
#1
André Moreira-Rosário, Helder Pinheiro, Conceição Calhau, Luís Filipe Azevedo
INTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now...
November 10, 2016: BMJ Open
https://www.readbyqxmd.com/read/28141763/use-of-video-games-for-the-treatment-of-amblyopia
#2
Alexander J E Foss
PURPOSE OF REVIEW: To review the literature up to recent for the use of videos, videogames and dichoptic stimulation as a treatment for amblyopia. RECENT FINDINGS: There have been three strategies explored. The first is to use videos and videogames monocularly with the normal eye covered. The second is dichoptic stimulation with a common background presented to both eyes and an enriched foreground to the amblyopic eye. The third are games specifically designed to generate stereopsis...
January 30, 2017: Current Opinion in Ophthalmology
https://www.readbyqxmd.com/read/28103052/adjunctive-treatment-of-psychotic-disorders-with-micronutrients
#3
Lewis Mehl-Madrona, Barbara Mainguy
OBJECTIVE: To evaluate the effect of micronutrients (minerals and vitamins) on adult psychosis when added to conventional medications by using a placebo-controlled randomized design with a 1-month open-label run-in. DESIGN: Longitudinal comparison study following a randomized, controlled trial that had failed because participants declined to undergo randomization. Setting/Locations: Rural primary care and psychiatry clinic in northern New England (town of 16,000 people)...
January 19, 2017: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/28072811/evaluation-of-the-ototoxicity-potential-of-once-daily-single-entity-hydrocodone-in-patients-with-chronic-pain-results-of-two-phase-3-clinical-studies
#4
Kathleen Campbell, J Walter Kutz, Angela Shoup, Warren Wen, Shau Yu Lynch, Ellie He, Steven R Ripa
BACKGROUND: Use/misuse of the opioid combination hydrocodone-acetaminophen has been associated with permanent hearing loss. Although reports have been rare, this potential effect can have significant detrimental effect on patients' overall quality of life. To date, the ototoxic effect of hydrocodone alone has not been systematically investigated. OBJECTIVE: In this report, we aimed to evaluate the potential ototoxicity of a novel, single-entity, once-daily, extended-release hydrocodone tablet (Hysingla® ER; HYD)...
January 2017: Pain Physician
https://www.readbyqxmd.com/read/28068927/subgroup-identification-of-early-preterm-birth-eptb-informing-a-future-prospective-enrichment-clinical-trial-design
#5
Chuanwu Zhang, Lili Garrard, John Keighley, Susan Carlson, Byron Gajewski
BACKGROUND: Despite the widely recognized association between the severity of early preterm birth (ePTB) and its related severe diseases, little is known about the potential risk factors of ePTB and the sub-population with high risk of ePTB. Moreover, motivated by a future confirmatory clinical trial to identify whether supplementing pregnant women with docosahexaenoic acid (DHA) has a different effect on the risk subgroup population or not in terms of ePTB prevalence, this study aims to identify potential risk subgroups and risk factors for ePTB, defined as babies born less than 34 weeks of gestation...
January 10, 2017: BMC Pregnancy and Childbirth
https://www.readbyqxmd.com/read/28063238/aspergillus-awamori-fermented-mung-bean-seed-coats-enhance-the-antioxidant-and-immune-responses-of-weaned-pigs
#6
D N Lee, Y S Hung, T S Yang, J H Lin, C F Weng
The potential benefits of Aspergillus-fermented mung bean seed coats (FMSC) for weaned pigs remain unexplored. Both in vitro and in vivo experiments were employed to evaluate the potential of FMSC supplement on the growth, antioxidant and immune responses of weaned pigs. The total polyphenols and DPPH scavenging capability of ethanol extract of FMSC exhibited a greater (p < 0.01) increase than those of pre-fermentation. With the addition of the polyphenol of FMSC extract, an increase in phagocytosis by neutrophils and proliferation of peripheral blood mononuclear cells (PBMC) were found...
January 7, 2017: Journal of Animal Physiology and Animal Nutrition
https://www.readbyqxmd.com/read/28060849/behavior-of-pigs-reared-in-enriched-environment-alternatives-to-extend-pigs-attention
#7
Simone Pereira Machado, Fabiana Ribeiro Caldara, Luciana Foppa, Rafael de Moura, Liliane Maria Piano Gonçalves, Rodrigo Garófallo Garcia, Irenilza de Alencar Nääs, Viviane Maria Oliveira Dos Santos Nieto, Geyssane Farias de Oliveira
Three trials were carried out in a completely randomized design aiming to assess the behavior of pigs in growth phase in enriched environments. Trial 1 evaluated the effects of frequency of availability of environmental enrichment. The animals were assigned to four treatments: 1) control with no enrichment object; 2) objects provided for six consecutive days uninterruptedly; 3) objects provided on alternate days, and 4) objects provided for six consecutive days taken away by the end of the afternoon and replaced at dawn...
2017: PloS One
https://www.readbyqxmd.com/read/28000601/isolation-of-tasmanian-rickettsia-like-organism-rlo-from-farmed-salmonids-identification-of-multiple-serotypes-and-confirmation-of-pathogenicity
#8
R N Morrison, N D Young, G Knowles, M C Cornish, J Carson
Atlantic salmon Salmo salar L. farmed in south-east Tasmania, Australia, are susceptible to infection by the Tasmanian Rickettsia-like organism (TRLO), a Gram-negative bacterium. Here, we report the first isolation of TRLO from south-east Tasmania in pure culture and show that the bacterium is culturable on both specialised enriched agar and in cell culture using the CHSE-214 cell line. In vitro cultured TRLO was used to reproducibly elicit disease in Atlantic salmon parr held in fresh water. In inoculated fish, TRLO was observed intracytoplasmically in peripheral blood leucocytes, suggesting that these cells are responsible for haematogenous dispersal of the bacterium within the host...
December 21, 2016: Diseases of Aquatic Organisms
https://www.readbyqxmd.com/read/27980494/in-vivo-osteoinduction-evaluating-2-beta-coxatene-as-an-immunoinductive-compound-and-novel-ingredient-for-joint-support
#9
Katherine Spinks, James J Scaffidi
CONTEXT: Osteoarthritis (OA) is a degenerative joint disease characterized by progressive loss of articular cartilage. Many treatments lack the ability to stimulate the growth of native cartilage tissue while they simultaneously increase joint comfort. For the past few decades, dietary supplements have been investigated for the ability to both address joint inflammation and stimulate cartilage tissue. OBJECTIVES: The present study intended to examine the supplement's in vivo osteoinductive capabilities and clinical efficacy for overall joint health...
October 2016: Integrative Medicine
https://www.readbyqxmd.com/read/27919389/older-patients-use-of-technology-for-a-post-discharge-nutritional-intervention-a-mixed-methods-feasibility-study
#10
T Lindhardt, M H Nielsen
BACKGROUND: Malnutrition is frequent in older people and a precursor for morbidity and hospitalisation; furthermore low intake and weight loss during and after hospitalisation is well-described. Such patients are often excluded from technology projects on account of lack of skills. This is a barrier for their access to many current and future health care offers. OBJECTIVES: To test the acceptability, feasibility and preliminary efficacy of technology-supported energy- and protein-enforced homedelivered meals for older patients discharged from hospital...
January 2017: International Journal of Medical Informatics
https://www.readbyqxmd.com/read/27919361/adverse-effects-on-insulin-secretion-of-replacing-saturated-fat-with-refined-carbohydrate-but-not-with-monounsaturated-fat-a-randomized-controlled-trial-in-centrally-obese-subjects
#11
Lin F Chang, Shireene R Vethakkan, Kalanithi Nesaretnam, Thomas A B Sanders, Kim-Tiu Teng
BACKGROUND: Current dietary guidelines recommend the replacement of saturated fatty acids (SAFAs) with carbohydrates or monounsaturated fatty acids (MUFAs) based on evidence on lipid profile alone, the chronic effects of the mentioned replacements on insulin secretion and insulin sensitivity are however unclear. OBJECTIVE: To assess the chronic effects of the substitution of refined carbohydrate or MUFA for SAFA on insulin secretion and insulin sensitivity in centrally obese subjects...
November 2016: Journal of Clinical Lipidology
https://www.readbyqxmd.com/read/27917685/phosphodiesterase-10-inhibitors-in-clinical-development-for-cns-disorders
#12
Hugo Geerts, Athan Spiros, Patrick Roberts
Phosphodiesterase 10 inhibitors (PDE10-I), are conceptually attractive drugs with a potential great therapeutic window as their enriched striatal localization may likely stimulate D1R and reduce D2R downstream effects. However, so far selective PDE10-I with efficacy in animal models have not shown benefit in clinical trials and unexpectedly revealed a substantial dyskinesia motor side-effect. Areas covered: This paper reviews the underlying biological rationale of PDE10 as a target in schizophrenia, Parkinson's and Huntington's disease based on peer-reviewed published articles, the status of the different PDE10-I in clinical development for various CNS indications and explores possible reasons for the clinical trial failures and translational disconnect...
December 10, 2016: Expert Review of Neurotherapeutics
https://www.readbyqxmd.com/read/27914517/effect-of-flaxseed-oil-and-microalgae-dha-on-the-production-performance-fatty-acids-and-total-lipids-of-egg-yolk-and-plasma-in-laying-hens
#13
M Neijat, O Ojekudo, J D House
The incorporation of omega-3 polyunsaturated fatty acids (PUFA) in the egg is dependent on both the transfer efficiency of preformed dietary omega-3 fatty acids to the eggs as well as endogenous PUFA metabolism and deposition. Employing an experimental design consisting of 70 Lohmann LSL-Classic hens (n=10/treatment) in a 6-week feeding trial, we examined the impact of graded levels of either flaxseed oil (alpha-linolenic acid, ALA) or algal DHA (preformed docosahexaenoic acid, DHA), each supplying 0.20%, 0...
December 2016: Prostaglandins, Leukotrienes, and Essential Fatty Acids
https://www.readbyqxmd.com/read/27899529/short-term-effects-of-trans-fatty-acids-from-ruminant-and-industrial-sources-on-surrogate-markers-of-cardiovascular-risk-in-healthy-men-and-women-a-randomized-controlled-double-blind-trial
#14
Thomas Radtke, Alexandra Schmid, Anja Trepp, Frieda Dähler, Michael Coslovsky, Prisca Eser, Matthias Wilhelm, Hugo Saner
OBJECTIVE: The aim of this study was to determine short-term effects of trans fatty acid (TFA) intake from ruminant and industrial sources on surrogate markers of cardiovascular risk in the context of a balanced diet with 30-36% of daily energy from fat. DESIGN: Prospective, randomized, double-blind, parallel-design study. METHODS: In this study, 142 healthy volunteers aged 45 to 69 years were randomly allocated to three different diets: either a diet enriched with 2% of daily energy intake from ruminant TFA (rTFA) or with industrial TFA (iTFA), or a diet without TFA (wTFA), for a duration of four weeks...
November 29, 2016: European Journal of Preventive Cardiology
https://www.readbyqxmd.com/read/27895297/power-of-an-adaptive-trial-design-for-endovascular-stroke-studies-simulations-using-ims-interventional-management-of-stroke-iii-data
#15
Maarten G Lansberg, Ninad S Bhat, Sharon D Yeatts, Yuko Y Palesch, Joseph P Broderick, Gregory W Albers, Tze L Lai, Philip W Lavori
BACKGROUND AND PURPOSE: Adaptive trial designs that allow enrichment of the study population through subgroup selection can increase the chance of a positive trial when there is a differential treatment effect among patient subgroups. The goal of this study is to illustrate the potential benefit of adaptive subgroup selection in endovascular stroke studies. METHODS: We simulated the performance of a trial design with adaptive subgroup selection and compared it with that of a traditional design...
December 2016: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/27893485/peripheral-neuropathic-pain-a-mechanism-related-organizing-principle-based-on-sensory-profiles
#16
Ralf Baron, Christoph Maier, Nadine Attal, Andreas Binder, Didier Bouhassira, Giorgio Cruccu, Nanna B Finnerup, Maija Haanpää, Per Hansson, Philipp Hüllemann, Troels S Jensen, Rainer Freynhagen, Jeffrey D Kennedy, Walter Magerl, Tina Mainka, Maren Reimer, Andrew S C Rice, Märta Segerdahl, Jordi Serra, Sören Sindrup, Claudia Sommer, Thomas Tölle, Jan Vollert, Rolf-Detlef Treede
Patients with neuropathic pain are heterogeneous in etiology, pathophysiology, and clinical appearance. They exhibit a variety of pain-related sensory symptoms and signs (sensory profile). Different sensory profiles might indicate different classes of neurobiological mechanisms, and hence subgroups with different sensory profiles might respond differently to treatment. The aim of the investigation was to identify subgroups in a large sample of patients with neuropathic pain using hypothesis-free statistical methods on the database of 3 large multinational research networks (German Research Network on Neuropathic Pain (DFNS), IMI-Europain, and Neuropain)...
February 2017: Pain
https://www.readbyqxmd.com/read/27862920/alternative-designs-for-clinical-trials-in-rare-diseases
#17
Lusine Abrahamyan, Brian M Feldman, George Tomlinson, Marie E Faughnan, Sindhu R Johnson, Ivan R Diamond, Samir Gupta
Evidence-based medicine requires strong scientific evidence upon which to base treatment. In rare diseases, study populations are often small, and thus this evidence is difficult to accrue. Investigators, though, should be creative and develop a flexible toolkit of methods to deal with the problems inherent in the study of rare disease. This narrative review presents alternative clinical trial designs for studying treatments of rare diseases, including cross-over and n-of-1 trials, randomized placebo-phase design, enriched enrollment, randomized withdrawal design, and classes of adaptive designs...
December 2016: American Journal of Medical Genetics. Part C, Seminars in Medical Genetics
https://www.readbyqxmd.com/read/27861362/effects-of-target-controlled-infusion-of-high-dose-naloxone-on-pain-and-hyperalgesia-in-a-human-thermal-injury-model-a-study-protocol-a-randomized-double-blind-placebo-controlled-crossover-trial-with-an-enriched-design
#18
RANDOMIZED CONTROLLED TRIAL
Anders D Springborg, Elisabeth K Jensen, Bradley K Taylor, Mads U Werner
Mu-opioid-receptor antagonists have been extensively studied in experimental research as pharmacological tools uncovering mechanisms of pain modulation by the endogenous opioid system. In rodents, administration of high doses of mu-opioid-receptor antagonists after the resolution of an inflammatory injury has demonstrated reinstatement of nociceptive hypersensitivity indicating unmasking of latent sensitization. In a recent human study, pain hypersensitivity assessed as secondary hyperalgesia area (SHA), was reinstated 7 days after a mild thermal injury, in 4 out of 12 subjects after a naloxone infusion...
November 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27858251/methodological-issues-in-clinical-trials-of-polycystic-kidney-disease-a-focused-review
#19
REVIEW
Ioan-Andrei Iliuta, Abhijat Kitchlu, York Pei
The field of therapeutics in autosomal dominant polycystic kidney disease (ADPKD) has seen a significant expansion recently, as major clinical trials have provided promising evidence in favor of new disease-modifying drugs. Though these trials are encouraging, limitations are noticeable in the form of methodological issues that restrict the interpretation of results. In this review, we discuss the methodological pitfalls of high-profile clinical interventional trials for ADPKD which have been published since 2009...
November 17, 2016: Journal of Nephrology
https://www.readbyqxmd.com/read/27856273/hypermutation-in-pancreatic-cancer
#20
Jeremy L Humphris, Ann-Marie Patch, Katia Nones, Peter J Bailey, Amber L Johns, Skye McKay, David K Chang, David K Miller, Marina Pajic, Karin S Kassahn, Michael C J Quinn, Timothy J C Bruxner, Angelika N Christ, Ivon Harliwong, Senel Idrisoglu, Suzanne Manning, Craig Nourse, Ehsan Nourbakhsh, Andrew Stone, Peter J Wilson, Matthew Anderson, J Lynn Fink, Oliver Holmes, Stephen Kazakoff, Conrad Leonard, Felicity Newell, Nick Waddell, Scott Wood, Ronald S Mead, Qinying Xu, Jianmin Wu, Mark Pinese, Mark J Cowley, Marc D Jones, Adnan M Nagrial, Venessa T Chin, Lorraine A Chantrill, Amanda Mawson, Angela Chou, Christopher J Scarlett, Andreia V Pinho, Ilse Rooman, Marc Giry-Laterriere, Jaswinder S Samra, James G Kench, Neil D Merrett, Christopher W Toon, Krishna Epari, Nam Q Nguyen, Andrew Barbour, Nikolajs Zeps, Nigel B Jamieson, Colin J McKay, C Ross Carter, Euan J Dickson, Janet S Graham, Fraser Duthie, Karin Oien, Jane Hair, Jennifer P Morton, Owen J Sansom, Robert Grützmann, Ralph H Hruban, Anirban Maitra, Christine A Iacobuzio-Donahue, Richard D Schulick, Christopher L Wolfgang, Richard A Morgan, Rita T Lawlor, Borislav Rusev, Vincenzo Corbo, Roberto Salvia, Ivana Cataldo, Giampaolo Tortora, Margaret A Tempero, Oliver Hofmann, James R Eshleman, Christian Pilarsky, Aldo Scarpa, Elizabeth A Musgrove, Anthony J Gill, John V Pearson, Sean M Grimmond, Nicola Waddell, Andrew V Biankin
Pancreatic cancer is molecularly diverse, with few effective therapies. Increased mutation burden and defective DNA repair are associated with response to immune checkpoint inhibitors in several other cancer types. We interrogated 385 pancreatic cancer genomes to define hypermutation and its causes. Mutational signatures inferring defects in DNA repair were enriched in those with the highest mutation burdens. Mismatch repair deficiency was identified in 1% of tumors harboring different mechanisms of somatic inactivation of MLH1 and MSH2...
January 2017: Gastroenterology
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