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adaptive clinical trials

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https://www.readbyqxmd.com/read/29914097/oncolytic-reovirus-and-immune-checkpoint-inhibition-as-a-novel-immunotherapeutic-strategy-for-breast-cancer
#1
Ahmed A Mostafa, Daniel E Meyers, Chandini M Thirukkumaran, Peter J Liu, Kathy Gratton, Jason Spurrell, Qiao Shi, Satbir Thakur, Don G Morris
As the current efficacy of oncolytic viruses (OVs) as monotherapy is limited, exploration of OVs as part of a broader immunotherapeutic treatment strategy for cancer is necessary. Here, we investigated the ability for immune checkpoint blockade to enhance the efficacy of oncolytic reovirus (RV) for the treatment of breast cancer (BrCa). In vitro, oncolysis and cytokine production were assessed in human and murine BrCa cell lines following RV exposure. Furthermore, RV-induced upregulation of tumor cell PD-L1 was evaluated...
June 15, 2018: Cancers
https://www.readbyqxmd.com/read/29913107/a-class-of-covariate-adjusted-response-adaptive-allocation-designs-for-multitreatment-binary-response-trials
#2
Atanu Biswas, Rahul Bhattacharya
A class of covariate-adjusted response-adaptive randomization procedures is developed for binary treatment outcomes in a phase III clinical trial set up involving multiple treatments. The target allocation is developed by combining the ethical aspects with statistical precision under the existence of treatment covariate interaction. Relevant measures of the performance for the proposed allocation designs are studied and compared.
June 18, 2018: Journal of Biopharmaceutical Statistics
https://www.readbyqxmd.com/read/29912645/use-of-a-modified-bubble-continuous-positive-airway-pressure-bcpap-device-for-children-in-respiratory-distress-in-low-and-middle-income-countries-a-safety-study
#3
Ashley R Bjorklund, Beatrice Odongkara Mpora, Marie E Steiner, Gwenyth Fischer, Cynthia S Davey, Tina M Slusher
BACKGROUND: While bubble continuous positive airway pressure (bCPAP) is commonly used in low- and middle-income countries (LMIC) to support neonates with respiratory distress, there are limited non-invasive support options for non-neonatal children. AIM: To demonstrate safety of a new device designed to support children during respiratory distress in LMIC. METHODS: A paediatric bCPAP device was designed called SEAL-bCPAP (Simplified Ear-plug Adapted-bCPAP)...
June 18, 2018: Paediatrics and International Child Health
https://www.readbyqxmd.com/read/29912281/evaluating-longitudinal-markers-under-two-phase-study-designs
#4
Marlena Maziarz, Tianxi Cai, Li Qi, Anna S Lok, Yingye Zheng
Little attention has been given to the design of efficient studies to evaluate longitudinal biomarkers. Measuring longitudinal markers on an entire cohort is cost prohibitive and, especially for rare outcomes such as cancer, may be infeasible. Thus, methods for evaluation of longitudinal biomarkers using efficient and cost-effective study designs are needed. Case cohort (CCH) and nested case-control (NCC) studies allow investigators to evaluate biomarkers rigorously and at reduced cost, with only a small loss in precision...
April 18, 2018: Biostatistics
https://www.readbyqxmd.com/read/29911577/the-dynamics-of-the-pain-system-is-intact-in-patients-with-knee-osteoarthritis-an-exploratory-experimental-study
#5
Tanja Schjødt Jørgensen, Marius Henriksen, Sara Rosager, Louise Klokker, Karen Ellegaard, Bente Danneskiold-Samsøe, Henning Bliddal, Thomas Graven-Nielsen
Background and aims Despite the high prevalence of knee osteoarthritis (OA) it remains one of the most frequent knee disorders without a cure. Pain and disability are prominent clinical features of knee OA. Knee OA pain is typically localized but can also be referred to the thigh or lower leg. Widespread hyperalgesia has been found in knee OA patients. In addition, patients with hyperalgesia in the OA knee joint show increased pain summation scores upon repetitive stimulation of the OA knee suggesting the involvement of facilitated central mechanisms in knee OA...
December 29, 2017: Scandinavian Journal of Pain
https://www.readbyqxmd.com/read/29911409/the-ottawa-panel-guidelines-on-programmes-involving-therapeutic-exercise-for-the-management-of-hand-osteoarthritis
#6
Lucie Brosseau, Odette Thevenot, Olivia MacKiddie, Jade Taki, George A Wells, Paulette Guitard, Guillaume Léonard, Nicole Paquet, Sibel Z Aydin, Karine Toupin-April, Sabrina Cavallo, Rikke Helene Moe, Kamran Shaikh, Wendy Gifford, Laurianne Loew, Gino De Angelis, Shirin Mehdi Shallwani, Ala' S Aburub, Aline Mizusaki Imoto, Prinon Rahman, Inmaculada C Álvarez Gallardo, Milkana Borges Cosic, Nina Østerås, Sabrina Lue, Tokiko Hamasaki, Nathaly Gaudreault, Tanveer E Towheed, Sahil Koppikar, Ingvild Kjeken, Dharini Mahendira, Glen P Kenny, Gail Paterson, Marie Westby, Lucie Laferrière, Guy Longchamp
OBJECTIVE: To identify programmes involving therapeutic exercise that are effective for the management of hand osteoarthritis and to provide stakeholders with updated, moderate to high-quality recommendations supporting exercises for hand osteoarthritis. METHODS: A systematic search and adapted selection criteria included comparable trials with exercise programmes for managing hand osteoarthritis. Based on the evaluated evidence, a panel of experts reached consensus through a Delphi approach endorsing the recommendations...
June 1, 2018: Clinical Rehabilitation
https://www.readbyqxmd.com/read/29911107/colorectal-cancer-genomics-and-designing-rational-trials
#7
REVIEW
Sebastian Mondaca, Rona Yaeger
The widespread use of next generation sequencing (NGS) has led to a refined understanding of the genomics of colorectal cancer (CRC). However, progress in the use of molecular biomarkers in standard practice has been slow, and there is no approved targeted therapy for CRC based on a positive predictive marker yet. In this review, we will first summarize biomarkers with clinical utility in standard practice or targeted therapy trials and then consider how to rationally design clinical trials to more effectively target CRC...
May 2018: Annals of Translational Medicine
https://www.readbyqxmd.com/read/29909372/an-international-qualitative-study-exploring-patients-experiences-of-cutaneous-leishmaniasis-study-set-up-and-protocol
#8
Astrid Christine Erber, Byron Arana, Issam Bennis, Afif Ben Salah, Aicha Boukthir, Maria Del Mar Castro Noriega, Mamoudou Cissé, Gláucia Fernandes Cota, Farhad Handjani, Mairie Guizaw Kebede, Trudie Lang, Liliana López Carvajal, Kevin Marsh, Dalila Martinez Medina, Emma Plugge, Piero Olliaro
INTRODUCTION: Lack of investments in drug development, lack of standardisation of clinical trials and the complexity of disease presentations contribute to the current lack of effective, safe and adapted treatments for cutaneous leishmaniasis (CL). One aspect concerns outcomes affecting patients' quality of life (QoL): these are hardly assessed in trials, despite potential functional and/or aesthetic impairment caused by CL, which typically affects disadvantaged and vulnerable people living in rural areas...
June 15, 2018: BMJ Open
https://www.readbyqxmd.com/read/29908991/mage-a3-immunotherapeutic-as-adjuvant-therapy-for-patients-with-resected-mage-a3-positive-stage-iii-melanoma-derma-a-double-blind-randomised-placebo-controlled-phase-3-trial
#9
Brigitte Dreno, John F Thompson, Bernard Mark Smithers, Mario Santinami, Thomas Jouary, Ralf Gutzmer, Evgeny Levchenko, Piotr Rutkowski, Jean-Jacques Grob, Sergii Korovin, Kamil Drucis, Florent Grange, Laurent Machet, Peter Hersey, Ivana Krajsova, Alessandro Testori, Robert Conry, Bernard Guillot, Wim H J Kruit, Lev Demidov, John A Thompson, Igor Bondarenko, Jaroslaw Jaroszek, Susana Puig, Gabriela Cinat, Axel Hauschild, Jelle J Goeman, Hans C van Houwelingen, Fernando Ulloa-Montoya, Andrea Callegaro, Benjamin Dizier, Bart Spiessens, Muriel Debois, Vincent G Brichard, Jamila Louahed, Patrick Therasse, Channa Debruyne, John M Kirkwood
BACKGROUND: Despite newly approved treatments, metastatic melanoma remains a life-threatening condition. We aimed to evaluate the efficacy of the MAGE-A3 immunotherapeutic in patients with stage IIIB or IIIC melanoma in the adjuvant setting. METHODS: DERMA was a phase 3, double-blind, randomised, placebo-controlled trial done in 31 countries and 263 centres. Eligible patients were 18 years or older and had histologically proven, completely resected, stage IIIB or IIIC, MAGE-A3-positive cutaneous melanoma with macroscopic lymph node involvement and an Eastern Cooperative Oncology Group performance score of 0 or 1...
June 13, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29908871/an-overview-on-personalisation-of-radiotherapy-prescriptions-in-locally-advanced-non-small-cell-lung-cancer-are-we-there-yet
#10
REVIEW
Sarah Barrett, Gerard G Hanna, Laure Marignol
Standard of care radiotherapy in LA-NSCLC is 60-66 Gy in 30-33 fractions. However outcomes for these patients are poor with 5-year survival in the range of 10-20%. Randomised controlled trials have shown that dose escalation in a linear fashion does not improve outcomes for all patients, thus there is a need to tailor the prescription to the individual patient. This review assesses the strategies published to personalise the radiation therapy dose prescription in LA-NSCLC. A systematic and scoping search of the literature was performed to identify studies that met the inclusion criteria...
June 13, 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
https://www.readbyqxmd.com/read/29908345/functional-and-physiological-adaptations-following-concurrent-training-using-sets-with-and-without-concentric-failure-in-elderly-men-a-randomized-clinical-trial
#11
Eduardo Lusa Cadore, Erik Menger, Juliana Lopes Teodoro, Larissa Xavier Neves da Silva, Francesco Pinto Boeno, Daniel Umpierre, Cíntia Ehlers Botton, Rodrigo Ferrari, Giovani Dos Santos Cunha, Mikel Izquierdo, Ronei Silveira Pinto
This study compared the functional and physiological adaptations induced by concurrent training (CT) performed with repetitions to concentric failure and not to failure in elderly men. Fifty-two individuals (66.2 ± 5.2 years) completed the pre- and post-measurements and were divided into three groups: repetitions to failure (RFG, n = 17); repetitions not to failure (NFG, n = 20); and repetitions not to failure with total volume equalized to that in the RFG (ENFG, n = 15). The participants' sit-to-stand ability, timed-up-and-go (TUG), muscle power output in squat jump (SJ) and countermovement jump (CMJ), peak oxygen uptake (VO2peak ), blood lipids and glucose, as well as blood pressure levels were assessed...
June 13, 2018: Experimental Gerontology
https://www.readbyqxmd.com/read/29907380/monoclonal-gammopathies-of-unknown-significance-and-smoldering-myeloma-assessment-and-management-of-the-elderly-patients
#12
Verónica González-Calle, María Victoria Mateos
Monoclonal gammopathy of unknown significance (MGUS) is the most frequent plasma cell disorder that commonly affects elderly patients. Although it is an asymptomatic condition, as well as smoldering myeloma (SMM), the risk of progression to multiple myeloma requiring therapy or other B-cell disorders varies greatly for individual patients, remaining low for MGUS (1% per year), while higher and not uniform for SMM patients (10% per year). This scenario implies some special considerations regarding assessment and follow-up, especially in the elderly...
June 12, 2018: European Journal of Internal Medicine
https://www.readbyqxmd.com/read/29907363/critical-roles-of-inflammation-in-atherosclerosis
#13
REVIEW
Junji Moriya
There is accumulating evidence that vascular inflammation plays critical roles in pathophysiology of atherosclerosis. It is widely accepted that both innate and adaptive immune responses are important for initiation and progression of atherosclerosis, which mainly consist of monocytes, macrophages, neutrophils, T lymphocytes, and B lymphocytes. Moreover, inflammatory biomarkers such as high-sensitivity C-reactive protein and interleukin-6 are known to predict future cardiovascular events, as well as conventional low-density or high-density lipoprotein cholesterol...
June 12, 2018: Journal of Cardiology
https://www.readbyqxmd.com/read/29904752/nine-year-clinical-performance-of-a-hema-free-one-step-self-etch-adhesive-in-noncarious-cervical-lesions
#14
Marleen Peumans, Laura Wouters, Jan De Munck, Bart Van Meerbeek, Kirsten Van Landuyt
PURPOSE: One-step self-etch adhesives are among the most popular adhesives to directly bond composite to tooth tissue, mainly because of their perceived ease-of-use. The aim of this randomized controlled trial was to evaluate the clinical performance of a HEMA-free 1-step self-etch adhesive (1SEa), as compared with a 3-step etch-and-rinse adhesive (3E&Ra). MATERIALS AND METHODS: 267 non-carious cervical lesions in 52 patients were restored with a microhybrid composite Gradia Direct (GC), bonded in random order either with the HEMA-free 1SEa G-Bond (GB; GC) or the considered gold-standard 3E&Ra Optibond FL (OFL; Kerr)...
June 14, 2018: Journal of Adhesive Dentistry
https://www.readbyqxmd.com/read/29903930/spatial-normalization-of-18-f-flutemetamol-pet-images-utilizing-an-adaptive-principal-components-template
#15
Johan Lilja, Antoine Leuzy, Konstantinos Chiotis, Irina Savitcheva, Jens Sörensen, Agneta Nordberg
Though currently approved for visual assessment only, there is evidence to suggest that quantification of amyloid-β (Aβ) PET images may reduce inter-reader variability and aid in the monitoring of treatment effects in clinical trials. Quantification typically involves a regional atlas in standard space, requiring PET images to be spatially normalized. Different uptake patterns in Aβ-positive and Aβ-negative subjects, however, makes spatial normalization challenging. In this study we propose a method to spatially normalize [18 F]flutemetamol images, using a synthetic template based on principal component images to overcome these challenges...
June 14, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29902179/hybrid-stochastic-framework-predicts-efficacy-of-prophylaxis-against-hiv-an-example-with-different-dolutegravir-prophylaxis-schemes
#16
Sulav Duwal, Laura Dickinson, Saye Khoo, Max von Kleist
To achieve the 90-90-90 goals set by UNAIDS, the number of new HIV infections needs to decrease to approximately 500,000 by 2020. One of the 'five pillars' to achieve this goal is pre-exposure prophylaxis (PrEP). Truvada (emtricitabine-tenofovir) is currently the only medication approved for PrEP. Despite its advantages, Truvada is costly and requires individuals to adhere to the once-daily regimen. To improve PrEP, many next-generation regimen, including long-acting formulations, are currently investigated...
June 2018: PLoS Computational Biology
https://www.readbyqxmd.com/read/29899719/combined-cognitive-motor-rehabilitation-in-virtual-reality-improves-motor-outcomes-in-chronic-stroke-a-pilot-study
#17
Ana L Faria, Mónica S Cameirão, Joana F Couras, Joana R O Aguiar, Gabriel M Costa, Sergi Bermúdez I Badia
Stroke is one of the most common causes of acquired disability, leaving numerous adults with cognitive and motor impairments, and affecting patients' capability to live independently. Virtual Reality (VR) based methods for stroke rehabilitation have mainly focused on motor rehabilitation but there is increasing interest toward the integration of cognitive training for providing more effective solutions. Here we investigate the feasibility for stroke recovery of a virtual cognitive-motor task, the Reh@Task, which combines adapted arm reaching, and attention and memory training...
2018: Frontiers in Psychology
https://www.readbyqxmd.com/read/29898870/subtype-c-alvac-hiv-and-bivalent-subtype-c-gp120-mf59-hiv-1-vaccine-in-low-risk-hiv-uninfected-south-african-adults-a-phase-1-2-trial
#18
Linda-Gail Bekker, Zoe Moodie, Nicole Grunenberg, Fatima Laher, Georgia D Tomaras, Kristen W Cohen, Mary Allen, Mookho Malahleha, Kathryn Mngadi, Brodie Daniels, Craig Innes, Carter Bentley, Nicole Frahm, Daryl E Morris, Lynn Morris, Nonhlanhla N Mkhize, David C Montefiori, Marcella Sarzotti-Kelsoe, Shannon Grant, Chenchen Yu, Vijay L Mehra, Michael N Pensiero, Sanjay Phogat, Carlos A DiazGranados, Susan W Barnett, Niranjan Kanesa-Thasan, Marguerite Koutsoukos, Nelson L Michael, Merlin L Robb, James G Kublin, Peter B Gilbert, Lawrence Corey, Glenda E Gray, M Juliana McElrath
BACKGROUND: Modest efficacy was reported for the HIV vaccine tested in the RV144 trial, which comprised a canarypox vector (ALVAC) and envelope (env) glycoprotein (gp120). These vaccine components were adapted to express HIV-1 antigens from strains circulating in South Africa, and the adjuvant was changed to increase immunogenicity. Furthermore, 12-month immunisation was added to improve durability. In the HIV Vaccine Trials Network (HVTN) 100 trial, we aimed to assess this new regionally adapted regimen for advancement to efficacy testing...
June 8, 2018: Lancet HIV
https://www.readbyqxmd.com/read/29897275/editor-s-choice-diuretic-resistance-in-acute-heart-failure
#19
Frederik H Verbrugge
Diuretic resistance is a powerful predictor of adverse outcome in acute heart failure (AHF), irrespectively of underlying glomerular filtration rate. Metrics of diuretic efficacy such as natriuresis, urine output, weight loss, net fluid balance, or fractional sodium excretion, differ in their risk for measurement error, convenience, and biological plausibility, which should be taken into account when interpreting their results. Loop diuretic resistance in AHF has multiple causes including altered drug pharmacokinetics, impaired renal perfusion and effective circulatory volume, neurohumoral activation, post-diuretic sodium retention, the braking phenomenon and functional as well as structural adaptations in the nephron...
June 2018: European Heart Journal. Acute Cardiovascular Care
https://www.readbyqxmd.com/read/29896481/can-we-grow-valves-inside-the-heart-perspective-on-material-based-in-situ-heart-valve-tissue-engineering
#20
Carlijn V C Bouten, Anthal I P M Smits, Frank P T Baaijens
In situ heart valve tissue engineering using cell-free synthetic, biodegradable scaffolds is under development as a clinically attractive approach to create living valves right inside the heart of a patient. In this approach, a valve-shaped porous scaffold "implant" is rapidly populated by endogenous cells that initiate neo-tissue formation in pace with scaffold degradation. While this may constitute a cost-effective procedure, compatible with regulatory and clinical standards worldwide, the new technology heavily relies on the development of advanced biomaterials, the processing thereof into (minimally invasive deliverable) scaffolds, and the interaction of such materials with endogenous cells and neo-tissue under hemodynamic conditions...
2018: Frontiers in Cardiovascular Medicine
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