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Enriched trial design

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https://www.readbyqxmd.com/read/29769554/long-term-extension-of-a-randomised-controlled-trial-of-probiotics-using-electronic-health-records
#1
Gareth Davies, Sue Jordan, Caroline J Brooks, Daniel Thayer, Melanie Storey, Gareth Morgan, Stephen Allen, Iveta Garaiova, Sue Plummer, Mike Gravenor
Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years...
May 16, 2018: Scientific Reports
https://www.readbyqxmd.com/read/29765390/preclinical-evaluation-of-the-nevatm-stent-retriever-safety-and-efficacy-in-the-swine-thrombectomy-model
#2
Arthur J Ulm, Tigran Khachatryan, Arthur Grigorian, Raul G Nogueira
Background: A novel stent retriever device with an enhanced radial force profile, enlarged offset openings, and a closed distal end has been developed. Objective: Evaluate the safety and effectiveness of the NeVaTM thrombectomy device in animal model of thrombo-occlusive disease. Materials and Methods: Seven swine were used in safety and efficacy studies. Thrombo-occlusive disease was modeled using 4 emboli morphologies; 2 distinct models of autologous whole blood thrombi, plasma-enriched thrombi, and Onyx® emboli...
April 2018: Interventional Neurology
https://www.readbyqxmd.com/read/29747241/stiripentol-add-on-therapy-for-focal-refractory-epilepsy
#3
REVIEW
Francesco Brigo, Stanley C Igwe, Nicola Luigi Bragazzi
BACKGROUND: This is an updated version of the Cochrane review last published in 2015 (Issue 10). For nearly 30% of people with epilepsy, seizures are not controlled by current treatments. Stiripentol is a new antiepileptic drug (AED) that was developed in France and was approved by the European Medicines Agency (EMA) in 2007 for the treatment of Dravet syndrome as an adjunctive therapy with valproate and clobazam, with promising effects. OBJECTIVES: To evaluate the efficacy and tolerability of stiripentol as add-on treatment for people with focal refractory epilepsy who are taking AEDs...
May 10, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29730462/untying-the-gordion-knot-of-targeting-met-in-cancer
#4
REVIEW
Kanwal Raghav, Ann Marie Bailey, Jonathan M Loree, Scott Kopetz, Vijaykumar Holla, Timothy Anthony Yap, Fang Wang, Ken Chen, Ravi Salgia, David Hong
Despite compelling evidence backing the crucial role of a dysregulated MET axis in cancer and a myriad of agents targeting this pathway in active clinical development, the therapeutic value of MET inhibition in cancer oncology remains to be established. Although a series of disappointing clinical trials, at first, lessened fervor for targeting this pathway, investigations continue unabated with a number of novel active compounds entering clinical trials. Suboptimal designs which lacked biomarker selection have been the main reason for these early failures and this has stimulated a more biomarker enriched approach lately...
April 26, 2018: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/29728379/effects-of-ceftiofur-and-chlortetracycline-on-the-resistome-of-feedlot-cattle
#5
Margaret D Weinroth, H Morgan Scott, Bo Norby, Guy H Loneragan, Noelle R Noyes, Pablo Rovira, Enrique Doster, Xiang Yang, Dale R Woerner, Paul S Morley, Keith E Belk
Treatment of food producing animals with antimicrobial drugs (AMD) is controversial because of concerns regarding promotion of antimicrobial resistance (AMR). To investigate this concern, resistance genes in metagenomic bovine fecal samples during a clinical trial were analyzed to assess the impacts of treatment on beef feedlot cattle resistomes. Four groups of cattle were exposed, using a 2x2 factorial design, to different regimens of antimicrobial treatment. Injections of ceftiofur crystalline free acid (a third generation cephalosporin) were used to treat all cattle in treated pens vs...
May 4, 2018: Applied and Environmental Microbiology
https://www.readbyqxmd.com/read/29696195/sensitivity-of-adaptive-enrichment-trial-designs-to-accrual-rates-time-to-outcome-measurement-and-prognostic-variables
#6
Tianchen Qian, Elizabeth Colantuoni, Aaron Fisher, Michael Rosenblum
Adaptive enrichment designs involve rules for restricting enrollment to a subset of the population during the course of an ongoing trial. This can be used to target those who benefit from the experimental treatment. Trial characteristics such as the accrual rate and the prognostic value of baseline variables are typically unknown when a trial is being planned; these values are typically assumed based on information available before the trial starts. Because of the added complexity in adaptive enrichment designs compared to standard designs, it may be of special concern how sensitive the trial performance is to deviations from assumptions...
December 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/29692828/evaluation-of-four-pulpotomy-techniques-in-primary-molars-a-randomized-controlled-trial
#7
Ghassem Ansari, Seyyedeh Pouya Morovati, Saeed Asgary
Introduction: This trial was designed to evaluate the clinical and radiographic success rates of calcium-enriched mixture (CEM) cement with and without low level laser therapy (LLLT) and compare them to that of formocresol (FC) and ferric sulfate (FS) in primary molar pulpotomies. Methods and Materials: This randomized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3-9 years. Patients with at least four primary molars needing pulpotomy, were included in order to have each tooth assigned randomly in one of the four following groups; FC, FS, CEM, and LLLT/CEM...
2018: Iranian Endodontic Journal
https://www.readbyqxmd.com/read/29673375/stages-of-behavioural-change-after-direct-to-consumer-disease-risk-profiling-study-protocol-of-two-integrated-controlled-pragmatic-trials
#8
Kelly F J Stewart, Anke Wesselius, Annemie M W J Schols, Maurice P Zeegers
BACKGROUND: The incidence and prevalence of chronic diseases have reached epidemic proportions during the last decades and are not expected to diminish. Chronic diseases increasingly affect younger individuals too, with over 40% of all deaths due to non-communicable diseases occurring before the age of 70. This has led to the development of information services aimed at preventive health care, such as Health Potential®. This counselling service estimates a personal disease risk of a carefully selected list of preventable common chronic diseases that have both a genetic and a lifestyle component of development...
April 19, 2018: Trials
https://www.readbyqxmd.com/read/29667585/recent-developments-in-the-diagnosis-and-therapy-of-well-differentiated-neuroendocrine-tumours
#9
J Hofland, R A Feelders, T Brabander, G J H Franssen, W W de Herder
Well-differentiated neuroendocrine tumours (NETs) of the digestive tract are being increasingly detected, which is partly explained by the increased use of endoscopic and cross-sectional imaging as well as improved recognition at histopathological evaluation. After the discovery of this relatively indolent type of epithelial malignancy over 100 years ago, their sporadic occurrence and divergent biological behaviour at multiple primary sites have hampered dedicated studies into NET pathogenesis and testing of drug efficacy in well-designed clinical trials...
April 2018: Netherlands Journal of Medicine
https://www.readbyqxmd.com/read/29665951/statistical-considerations-for-pediatric-multidrug-resistant-tuberculosis-efficacy-trials
#10
S Kim, J A Seddon, A J Garcia-Prats, G Montepiedra
The inclusion of newly licensed or repurposed drugs in regimens to treat children for multidrug-resistant tuberculosis (TB) may lead to treatment that is shorter than traditional regimens and composed only of oral medications. As an all-oral regimen may be more acceptable and have a better safety profile than current regimens, demonstrating non-inferiority may be satisfactory. Demonstrating non-inferior efficacy requires setting a non-inferiority margin and safeguarding study assay sensitivity. Multi-arm, multistage designs may currently not be appropriate in pediatric trials because of the lack of sensitive and specific intermediate outcomes...
May 1, 2018: International Journal of Tuberculosis and Lung Disease
https://www.readbyqxmd.com/read/29658117/mapping-the-tumour-hla-ligandome-by-mass-spectrometry
#11
REVIEW
Lena Katharina Freudenmann, Ana Marcu, Stefan Stevanović
The entirety of HLA-presented peptides is referred to as the HLA ligandome of a cell or tissue, in tumours often termed immunopeptidome. Mapping the tumour immunopeptidome by mass spectrometry (MS) comprehensively views the pathophysiologically relevant antigenic signature of human malignancies. MS is an unbiased approach stringently filtering the candidates to be tested as opposed to epitope prediction algorithms. In the setting of peptide-specific immunotherapies, MS-based strategies significantly diminish the risk of lacking clinical benefit, as they yield highly enriched amounts of truly presented peptides...
April 15, 2018: Immunology
https://www.readbyqxmd.com/read/29656345/update-on-the-treatment-of-early-stage-triple-negative-breast-cancer
#12
REVIEW
Priyanka Sharma
Triple-negative breast cancer (TNBC) accounts for 15% of all breast cancers and is associated with poor long-term outcomes compared to other breast cancer subtypes. Currently, chemotherapy remains the main modality of treatment for early-stage TNBC, as there is no approved targeted therapy for this subtype. The biologic heterogeneity of TNBC has hindered the development and evaluation of novel agents, but recent advancements in subclassifying TNBC have paved the way for further investigation of more effective systemic therapies, including cytotoxic and targeted agents...
April 14, 2018: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/29644751/disease-modification-in-parkinson-s-disease-current-approaches-challenges-and-future-considerations
#13
REVIEW
Anthony E Lang, Alberto J Espay
The greatest unmet therapeutic need in Parkinson's disease is the development of treatment that slows the relentless progression of the neurodegenerative process. The concept of "disease modification" encompasses intervention types ranging from those designed to slow the underlying degeneration to treatments directed at regenerating or replacing lost neurons. To date all attempts to develop effective disease-modifying therapy have failed. Many reasons have been proposed for these failures including our rudimentary understanding of disease pathogenesis and the assumption that each targeted mechanisms of disease apply to most patients with the same clinical diagnosis...
April 11, 2018: Movement Disorders: Official Journal of the Movement Disorder Society
https://www.readbyqxmd.com/read/29621291/fungal-community-profiles-in-agricultural-soils-of-a-long-term-field-trial-under-different-tillage-fertilization-and-crop-rotation-conditions-analyzed-by-high-throughput-its-amplicon-sequencing
#14
Loreen Sommermann, Joerg Geistlinger, Daniel Wibberg, Annette Deubel, Jessica Zwanzig, Doreen Babin, Andreas Schlüter, Ingo Schellenberg
Fungal communities in agricultural soils are assumed to be affected by soil and crop management. Our intention was to investigate the impact of different tillage and fertilization practices on fungal communities in a long-term crop rotation field trial established in 1992 in Central Germany. Two winter wheat fields in replicated strip-tillage design, comprising conventional vs. conservation tillage, intensive vs. extensive fertilization and different pre-crops (maize vs. rapeseed) were analyzed by a metabarcoding approach applying Illumina paired-end sequencing of amplicons generated by two recently developed primer pairs targeting the two fungal Internal Transcribed Spacer regions (ITS1, ITS2)...
2018: PloS One
https://www.readbyqxmd.com/read/29619024/extracellular-ngfr-spacers-allow-efficient-tracking-and-enrichment-of-fully-functional-car-t-cells-co-expressing-a-suicide-gene
#15
Monica Casucci, Laura Falcone, Barbara Camisa, Margherita Norelli, Simona Porcellini, Anna Stornaiuolo, Fabio Ciceri, Catia Traversari, Claudio Bordignon, Chiara Bonini, Attilio Bondanza
Chimeric antigen receptor (CAR)-T cell immunotherapy is at the forefront of innovative cancer therapeutics. However, lack of standardization of cellular products within the same clinical trial and lack of harmonization between different trials have hindered the clear identification of efficacy and safety determinants that should be unveiled in order to advance the field. With the aim of facilitating the isolation and in vivo tracking of CAR-T cells, we here propose the inclusion within the CAR molecule of a novel extracellular spacer based on the low-affinity nerve-growth-factor receptor (NGFR)...
2018: Frontiers in Immunology
https://www.readbyqxmd.com/read/29606891/critical-concepts-in-adaptive-clinical-trials
#16
REVIEW
Jay Jh Park, Kristian Thorlund, Edward J Mills
Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules...
2018: Clinical Epidemiology
https://www.readbyqxmd.com/read/29604160/baseline-characteristics-and-enrichment-results-of-the-study-of-diabetic-nephropathy-with-atrasentan-sonar-trial
#17
Hiddo J L Heerspink, Dennis L Andress, George Bakris, John J Brennan, Ricardo Correa-Rotter, Fan Fan Hou, Dalane W Kitzman, Donald Kohan, Hirofumi Makino, John McMurray, Vlado Perkovic, Sheldon Tobe, Melissa Wigderson, Tingting Yi, Hans-Henrik Parving, Dick de Zeeuw
INTRODUCTION: The SONAR trial uses an enrichment design based on the individual response to the selective endothelin receptor antagonist atrasentan on efficacy (the degree of the individual response in urinary albumin:creatinine ratio, UACR), and safety/tolerability (signs of sodium retention and acute increases in serum creatinine) to assess the effects of this agent on major renal outcomes. The patient population and enrichment results are described here. METHODS: Patients with type 2 diabetes with estimated Glomerular Filtration Rate (eGFR) between 25 and 75 ml/min/1...
March 31, 2018: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/29570791/patient-enrichment-for-precision-based-cancer-clinical-trials-using-prospective-cohort-surveillance-as-an-approach-to-improve-clinical-trials
#18
William S Dalton, Daniel Sullivan, Jeffrey Ecsedy, Michael A Caligiuri
Technological advances have led to the identification of biomarkers and development of novel target-based therapies. While some novel therapies have improved patient outcomes, the prevalence and diversity of biomarkers and targets in patient populations, especially patients with cancer, has created a challenge for the design and performance of clinical trials. To address this challenge we propose that prospective cohort surveillance of patients may be a solution to promote clinical trial matching for patients in need...
March 23, 2018: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29562517/cerebrospinal-fluid-biomarkers-in-alzheimer-s-disease-an-invaluable-tool-for-clinical-diagnosis-and-trial-enrichment
#19
Lucilla Parnetti, Paolo Eusebi
Alzheimer's disease (AD) is the most common neurodegenerative disorder, affecting around 35 million people worldwide. Cerebrospinal fluid (CSF) biomarkers entered the diagnostic criteria as support for early diagnosis. The classical biochemical signature of AD includes total tau (T-tau), phosphorylated tau (P-tau), and the 42 amino acid peptide (Aβ42) of amyloid-β. Recent observations suggest that the use of CSF Aβ42:Aβ40 ratio rather than CSF Aβ42 alone could contribute to reduce inter-laboratory variation in Aβ values and increasing diagnostic performance of the CSF AD biomarkers in routine practice...
March 16, 2018: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/29540217/rationale-design-and-baseline-characteristics-of-the-cardiovascular-safety-and-renal-microvascular-outcome-study-with-linagliptin-carmelina-%C3%A2-a-randomized-double-blind-placebo-controlled-clinical-trial-in-patients-with-type-2-diabetes-and-high-cardio-renal
#20
Julio Rosenstock, Vlado Perkovic, John H Alexander, Mark E Cooper, Nikolaus Marx, Michael J Pencina, Robert D Toto, Christoph Wanner, Bernard Zinman, David Baanstra, Egon Pfarr, Michaela Mattheus, Uli C Broedl, Hans-Juergen Woerle, Jyothis T George, Maximilian von Eynatten, Darren K McGuire
BACKGROUND: Cardiovascular (CV) outcome trials in type 2 diabetes (T2D) have underrepresented patients with chronic kidney disease (CKD), leading to uncertainty regarding their kidney efficacy and safety. The CARMELINA® trial aims to evaluate the effects of linagliptin, a DPP-4 inhibitor, on both CV and kidney outcomes in a study population enriched for cardio-renal risk. METHODS: CARMELINA® is a randomized, double-blind, placebo-controlled clinical trial conducted in 27 countries in T2D patients at high risk of CV and/or kidney events...
March 14, 2018: Cardiovascular Diabetology
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