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Enriched trial design

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https://www.readbyqxmd.com/read/29322089/the-wisconsin-registry-for-alzheimer-s-prevention-a-review-of-findings-and-current-directions
#1
REVIEW
Sterling C Johnson, Rebecca L Koscik, Erin M Jonaitis, Lindsay R Clark, Kimberly D Mueller, Sara E Berman, Barbara B Bendlin, Corinne D Engelman, Ozioma C Okonkwo, Kirk J Hogan, Sanjay Asthana, Cynthia M Carlsson, Bruce P Hermann, Mark A Sager
The Wisconsin Registry for Alzheimer's Prevention is a longitudinal observational cohort study enriched with persons with a parental history (PH) of probable Alzheimer's disease (AD) dementia. Since late 2001, Wisconsin Registry for Alzheimer's Prevention has enrolled 1561 people at a mean baseline age of 54 years. Participants return for a second visit 4 years after baseline, and subsequent visits occur every 2 years. Eighty-one percent (1270) of participants remain active in the study at a current mean age of 64 and 9 years of follow-up...
2018: Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring
https://www.readbyqxmd.com/read/29321033/environmental-enrichment-intervention-for-rett-syndrome-an-individually-randomised-stepped-wedge-trial
#2
Jenny Downs, Jenny Rodger, Chen Li, Xuesong Tan, Nan Hu, Kingsley Wong, Nicholas de Klerk, Helen Leonard
BACKGROUND: Rett syndrome is caused by a pathogenic mutation in the MECP2 gene with major consequences for motor and cognitive development. One of the effects of impaired MECP2 function is reduced production of Brain Derived Neurotrophic Factor (BDNF), a protein required for normal neuronal development. When housed in an enriched environment, MECP2 null mice improved motor abilities and increased levels of BDNF in the brain. We investigated the effects of environmental enrichment on gross motor skills and blood BDNF levels in girls with Rett syndrome...
January 10, 2018: Orphanet Journal of Rare Diseases
https://www.readbyqxmd.com/read/29318971/-phenserine-and-inhibiting-pre-programmed-cell-death-in-pursuit-of-a-novel-intervention-for-alzheimer-s-disease
#3
Robert E Becker, Nigel H Greig, Debomoy K Lahiri, Joseph Bledsoe, Sarah Majercik, Clive Ballard, Dag Aarsland, Lon S Schneiderh, Douglas Flanagan, Ramprakash Govindarajani, Mary Sano, Luigi Ferrucci, Dimitrios Kapogiannisk
BACKGROUND: Concussion (mild) and other moderate traumatic brain injury (TBI) and Alzheimer's disease (AD) share overlapping neuropathologies, including neuronal pre-programmed cell death (PPCD), and clinical impairments and disabilities. Multiple clinical trials targeting mechanisms based on the Amyloid Hypothesis of AD have so far failed, indicating that it is prudent for new drug developments to also pursue mechanisms independent of the Amyloid Hypothesis. To address these issue, we have proposed the use of an animal model of concussion/TBI as a supplement to AD transgenic mice to provide an indication of an AD drug candidate's potential for preventing PPCD and resulting progression towards dementia in AD...
January 10, 2018: Current Alzheimer Research
https://www.readbyqxmd.com/read/29288987/machine-learning-based-prediction-of-brain-metastasis-of-patients-with-iiia-n2-lung-adenocarcinoma-by-a-three-mirna-signature
#4
Shuangtao Zhao, Jiangyong Yu, Luhua Wang
OBJECTIVES: MicroRNAs (miRNAs) play a key role in governing posttranscriptional regulation through binding to the mRNAs of target genes. This study is to assess miRNAs expression profiles for identifying brain metastasis-related miRNAs to develop the predictive model by microarray in tumor tissues. METHODS: For this study, we screened the significant brain metastasis-related miRNAs from 77 lung adenocarcinoma (LUAD) patients with brain metastasis (BM+) or non-brain metastasis (BM-)...
December 27, 2017: Translational Oncology
https://www.readbyqxmd.com/read/29286586/cognitive-enhancement-therapy-for-adult-autism-spectrum-disorder-results-of-an-18-month-randomized-clinical-trial
#5
Shaun M Eack, Susan S Hogarty, Deborah P Greenwald, Maralee Y Litschge, Shannondora A Porton, Carla A Mazefsky, Nancy J Minshew
Cognitive remediation is a promising approach to treating core cognitive deficits in adults with autism, but rigorously controlled trials of comprehensive interventions that target both social and non-social cognition over a sufficient period of time to impact functioning are lacking. This study examined the efficacy of cognitive enhancement therapy (CET) for improving core cognitive and employment outcomes in adult autism. Verbal adult outpatients with autism spectrum disorder (N = 54) were randomized to an 18-month, single-blind trial of CET, a cognitive remediation approach that integrates computer-based neurocognitive training with group-based training in social cognition, or an active enriched supportive therapy (EST) comparison focused on psychoeducation and condition management...
December 29, 2017: Autism Research: Official Journal of the International Society for Autism Research
https://www.readbyqxmd.com/read/29238948/antioxidants-for-preventing-and-reducing-muscle-soreness-after-exercise
#6
REVIEW
Mayur K Ranchordas, David Rogerson, Hora Soltani, Joseph T Costello
BACKGROUND: Muscle soreness typically occurs after intense exercise, unaccustomed exercise or actions that involve eccentric contractions where the muscle lengthens while under tension. It peaks between 24 and 72 hours after the initial bout of exercise. Many people take antioxidant supplements or antioxidant-enriched foods before and after exercise in the belief that these will prevent or reduce muscle soreness after exercise. OBJECTIVES: To assess the effects (benefits and harms) of antioxidant supplements and antioxidant-enriched foods for preventing and reducing the severity and duration of delayed onset muscle soreness following exercise...
December 14, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29220738/increasing-value-and-reducing-waste-by-optimizing-the-development-of-complex-interventions-enriching-the-development-phase-of-the-medical-research-council-mrc-framework
#7
Nienke Bleijenberg, Janneke M de Man-van Ginkel, Jaap C A Trappenburg, Roelof G A Ettema, Carolien G Sino, Noor Heim, Thóra B Hafsteindóttir, David A Richards, Marieke J Schuurmans
BACKGROUND: In recent years there has been much emphasis on 'research waste' caused by poor question selection, insufficient attention to previous research results, and avoidable weakness in research design, conduct and analysis. Little attention has been paid to the effect of inadequate development of interventions before proceeding to a full clinical trial. OBJECTIVE: We therefore propose to enrich the development phase of the MRC Framework by adding crucial elements to improve the likelihood of success and enhance the fit with clinical practice METHODS: Based on existing intervention development guidance and synthesis, a comprehensive iterative intervention development approach is proposed...
December 5, 2017: International Journal of Nursing Studies
https://www.readbyqxmd.com/read/29218740/enrichment-strategies-in-pediatric-drug-development-an-analysis-of-trials-submitted-to-the-us-food-and-drug-administration
#8
Dionna J Green, Xiaomei I Liu, Tianyi Hua, Janelle M Burnham, Robert Schuck, Michael Pacanowski, Lynne Yao, Susan K McCune, Gilbert J Burckart, Issam Zineh
Clinical trial enrichment involves prospectively incorporating trial design elements that increase the probability of detecting a treatment effect. The use of enrichment strategies in pediatric drug development has not been systematically assessed. We analyzed the use of enrichment strategies in pediatric trials submitted to the US Food and Drug Administration from 2012-2016. One hundred twelve efficacy studies associated with 76 drug development programs were assessed and their overall success rates were 78% and 75% respectively...
December 8, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29214034/identification-of-biomarkers-of-response-to-abatacept-in-patients-with-sle-using-deconvolution-of-whole-blood-transcriptomic-data-from-a-phase-iib-clinical-trial
#9
Somnath Bandyopadhyay, Sean E Connolly, Omar Jabado, June Ye, Sheila Kelly, Michael A Maldonado, Rene Westhovens, Peter Nash, Joan T Merrill, Robert M Townsend
Objective: To characterise patients with active SLE based on pretreatment gene expression-defined peripheral immune cell patterns and identify clusters enriched for potential responders to abatacept treatment. Methods: This post hoc analysis used baseline peripheral whole blood transcriptomic data from patients in a phase IIb trial of intravenous abatacept (~10 mg/kg/month). Cell-specific genes were used with a published deconvolution algorithm to identify immune cell proportions in patient samples, and unsupervised consensus clustering was generated...
2017: Lupus Science & Medicine
https://www.readbyqxmd.com/read/29211803/hypoxia-and-inactivity-related-physiological-changes-precede-or-take-place-in-absence-of-significant-rearrangements-in-bacterial-community-structure-the-planhab-randomized-trial-pilot-study
#10
Robert Šket, Nicole Treichel, Susanne Kublik, Tadej Debevec, Ola Eiken, Igor Mekjavić, Michael Schloter, Marius Vital, Jenna Chandler, James M Tiedje, Boštjan Murovec, Zala Prevoršek, Matevž Likar, Blaž Stres
We explored the assembly of intestinal microbiota in healthy male participants during the randomized crossover design of run-in (5 day) and experimental phases (21-day normoxic bed rest (NBR), hypoxic bed rest (HBR) and hypoxic ambulation (HAmb) in a strictly controlled laboratory environment, with balanced fluid and dietary intakes, controlled circadian rhythm, microbial ambiental burden and 24/7 medical surveillance. The fraction of inspired O2 (FiO2) and partial pressure of inspired O2 (PiO2) were 0.209 and 133...
2017: PloS One
https://www.readbyqxmd.com/read/29196495/comparative-transcriptome-profiling-reveals-coding-and-noncoding-rna-differences-in-nsclc-from-african-americans-and-european-americans
#11
Khadijah A Mitchell, Adriana Zingone, Leila Toulabi, Jacob Boeckelman, Bríd M Ryan
Purpose: To determine whether racial differences in gene and miRNA expression translates to differences in lung tumor biology with clinical relevance in African Americans (AAs) and European Americans (EAs).Experimental Design: The NCI-Maryland Case Control Study includes seven Baltimore City hospitals and is overrepresented with AA patients (∼40%). Patients that underwent curative NSCLC surgery between 1998 and 2014 were enrolled. Comparative molecular profiling used mRNA (n = 22 AAs and 19 EAs) and miRNA (n = 42 AAs and 55 EAs) expression arrays to track differences in paired fresh frozen normal tissues and lung tumor specimens from AAs and EAs...
December 1, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29194075/cutaneous-angiosarcoma-update-on-biology-and-latest-treatment
#12
Yoshihiro Ishida, Atsushi Otsuka, Kenji Kabashima
PURPOSE OF REVIEW: The present review aims to provide readers with the latest updates on the biology and clinical management of cutaneous angiosarcoma (cAS). RECENT FINDINGS: The genomic alteration of cAS is heterogeneous. Mutations are enriched in the mitosis-activated kinase (MAPK) pathway. Functional analysis has identified molecules that may serve as potential markers and therapeutic targets of angiosarcoma. These molecules include survivin, HSP90, FOXM1, miR-497-5p, KCa3...
November 30, 2017: Current Opinion in Oncology
https://www.readbyqxmd.com/read/29188875/intake-of-a-protein-enriched-milk-and-effects-on-muscle-mass-and-strength-a-12-week-randomized-placebo-controlled-trial-among-community-dwelling-older-adults
#13
I Ottestad, A T Løvstad, G O Gjevestad, H Hamarsland, J Šaltytė Benth, L F Andersen, A Bye, A S Biong, K Retterstøl, P O Iversen, T Raastad, S M Ulven, K B Holven
OBJECTIVES: To investigate the effect of 20 g protein with breakfast and evening meal on muscle mass, muscle strength and functional performance in older adults. DESIGN: A double-blinded randomized controlled study. SETTING: Oslo and Akershus University College of Applied Sciences, Norway. PARTICIPANTS: Healthy community-dwelling men and women (≥ 70 years) with reduced physical strength and/or performance. INTERVENTION: Subjects were randomly assigned to receive either protein-enriched milk (2 x 0...
2017: Journal of Nutrition, Health & Aging
https://www.readbyqxmd.com/read/29173203/25-oh-d3-enriched-or-fortified-foods-are-more-efficient-at-tackling-inadequate-vitamin-d-status-than-vitamin-d3
#14
Jing Guo, Julie A Lovegrove, D Ian Givens
The ability to synthesise sufficient vitamin D through sunlight in human subjects can be limited. Thus, diet has become an important contributor to vitamin D intake and status; however, there are only a few foods (e.g. egg yolk, oily fish) naturally rich in vitamin D. Therefore, vitamin D-enriched foods via supplementing the animals' diet with vitamin D or vitamin D fortification of foods have been proposed as strategies to increase vitamin D intake. Evidence that cholecalciferol (vitamin D3) and calcifediol (25(OH)D3) content of eggs, fish and milk increased in response to vitamin D3 supplementation of hens, fish or cows' diets was identified when vitamin D-enrichment studies were reviewed...
November 27, 2017: Proceedings of the Nutrition Society
https://www.readbyqxmd.com/read/29152847/a-case-study-in-identifying-targeted-patients-population-in-major-depressive-disorder-by-enhanced-enrichment-design
#15
Peter Zhang, Kevin Carroll, Mary Hobart, Carole Augustine, Gary Koch
Despite advances in clinical trial design, failure rates near 80% in phase 2 and 50% in phase 3 have recently been reported. The challenges to successful drug development are particularly acute in central nervous system trials such as for pain, schizophrenia, mania, and depression because high-placebo response rates lessen assay sensitivity, diminish estimated treatment effect sizes, and thereby decrease statistical power. This paper addresses the importance of rigorous patient selection in major depressive disorder trials through an enhanced enrichment paradigm...
November 19, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/29152241/effects-of-matrix-on-plasma-levels-of-epa-and-dha-in-dogs
#16
Kay Goffin, Marc van Maris, Ronald J Corbee
EPA and DHA are often used in veterinary medicine due to their beneficial effects for several medical conditions such as osteoarthritis. EPA and DHA are administered to dogs through different matrices. The aim of the present study was to determine the effects on the plasma levels in dogs caused by various matrices for EPA and DHA administration. In this study, three different n-3 PUFA formulations were used: soft chew tablet (CCx); liquid fish oil (LFO); and enriched kibbles (EK). The formulations were administered single-dose and compared in a randomised, cross-over designed study with a 1-week wash-out period...
2017: Journal of Nutritional Science
https://www.readbyqxmd.com/read/29142972/a-drug-development-tool-for-trial-enrichment-in-patients-with-autosomal-dominant-polycystic-kidney-disease
#17
Ronald D Perrone, Mohamad-Samer Mouksassi, Klaus Romero, Frank S Czerwiec, Arlene B Chapman, Berenice Y Gitomer, Vicente E Torres, Dana C Miskulin, Steve Broadbent, Jean F Marier
Introduction: Total kidney volume (TKV) is a promising imaging biomarker for tracking and predicting the natural history of patients with autosomal dominant polycystic kidney disease. Methods: A drug development tool was developed by linking longitudinal TKV measurements to the probability of a 30% decline of estimated glomerular filtration rate (eGFR) or end-stage renal disease. Drug development tools were developed based on observational data collected over multiple decades for an eGFR decline and end-stage renal disease in 641 and 866 patients with autosomal dominant polycystic kidney disease, respectively...
May 2017: KI Reports
https://www.readbyqxmd.com/read/29110741/effect-of-fibre-additions-to-flatbread-flour-mixes-on-glucose-kinetics-a-randomised-controlled-trial
#18
Hanny M Boers, Theo H van Dijk, Harry Hiemstra, Anne-Roos Hoogenraad, David J Mela, Harry P F Peters, Roel J Vonk, Marion G Priebe
We previously found that guar gum (GG) and chickpea flour (CPF) added to flatbread wheat flour lowered postprandial blood glucose (PPG) and insulin responses dose dependently. However, rates of glucose influx cannot be determined from PPG, which integrates rates of influx, tissue disposal and hepatic glucose production. The objective was to quantify rates of glucose influx and related fluxes as contributors to changes in PPG with GG and CPF additions to wheat-based flatbreads. In a randomised cross-over design, twelve healthy males consumed each of three different 13C-enriched meals: control flatbreads (C), or C incorporating 15 % CPF with either 2 % (GG2) or 4 % (GG4) GG...
November 7, 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/29100397/correlating-programmed-death-ligand-1-pd-l1-expression-mismatch-repair-deficiency-and-outcomes-across-tumor-types-implications-for-immunotherapy
#19
Seung Tae Kim, Samuel J Klempner, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang, Kyoung-Mee Kim, Jeeyun Lee
The identification of biomarkers associated with response to therapeutic agents is central to optimizing patient outcomes. Expression of the immune checkpoint proteins PD-1/L1, and DNA mismatch repair deficiency (dMMR) status may be predictive response biomarkers for immunotherapies, but their overlap requires further study. We prospectively conducted PD-L1 and MMR immunohistochemistry (IHC) on 430 consecutive patients with advanced gastrointestinal (GI) cancers, genitourinary (GU) cancers or rare cancers between June 2012 and March 2016...
September 29, 2017: Oncotarget
https://www.readbyqxmd.com/read/29094519/the-plan-of-enrichment-designs-for-dealing-with-high-placebo-response
#20
Xiangmin Zhang, Yeh-Fong Chen, Roy Tamura
To deal with high placebo response in clinical trials for psychiatric and other diseases, different enrichment designs, such as the sequential parallel design, two-way enriched design, and sequential enriched design, have been proposed and implemented recently. Depending on the historical trial information and the trial sponsors' resources, detailed design elements are needed for determining which design to adopt. To assist in making more suitable decisions, we perform evaluations for selecting required design elements in terms of power optimization and sample size planning...
November 1, 2017: Pharmaceutical Statistics
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