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adaptive clinical trials

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https://www.readbyqxmd.com/read/29474702/a-weight-loss-intervention-using-a-commercial-mobile-application-in-latino-americans-adelgaza-trial
#1
Yoshimi Fukuoka, Eric Vittinghoff, Julie Hooper
More than half of Latino adults living in the USA are expected to develop type 2 diabetes in their lifetime. Despite the growing interest in smartphone use for weight loss and diabetes prevention, relatively few clinical trials have evaluated the efficacy of mobile app-based interventions in Latino populations. The aim of this study was to evaluate the potential efficacy of an in-person weight loss intervention in conjunction with a commercially available Fitbit app in a Latino sample at risk for type 2 diabetes and explore significant predictors associated with weight loss...
February 21, 2018: Translational Behavioral Medicine
https://www.readbyqxmd.com/read/29473899/immune-responses-to-dengue-and-zika-viruses-guidance-for-t-cell-vaccine-development
#2
REVIEW
Claude Roth, Félix G Delgado, Etienne Simon-Lorière, Anavaj Sakuntabhai
Despite numerous efforts to identify the molecular and cellular effectors of the adaptive immunity that induce a long-lasting immunity against dengue or Zika virus infection, the specific mechanisms underlying such protective immunity remain largely unknown. One of the major challenges lies in the high level of dengue virus (DENV) seroprevalence in areas where Zika virus (ZIKV) is circulating. In the context of such a pre-existing DENV immunity that can exacerbate ZIKV infection and disease, and given the lack of appropriate treatment for ZIKV infection, there is an urgent need to develop an efficient vaccine against DENV and ZIKV...
February 23, 2018: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/29471442/estimation-of-adaptive-ventilation-success-and-failure-using-polysomnogram-and-outpatient-therapy-biomarkers
#3
Stacey Gunn, Sreelatha Naik, Matt Travis Bianchi, Robert Joseph Thomas
Study Objectives: Adaptive servo ventilation (ASV) devices provide anti-cyclic pressure support for treatment of central/complex sleep apnea, including in heart failure patients. Variability in responses in the clinic and negative clinical trials motivated assessment of standard and novel signal biomarkers for ASV efficacy. Methods: Multiple clinical databases were queried to assess potential signal biomarkers of ASV effectiveness, including 1) Attended laboratory adaptive ventilation titrations: 108, of which 66 had mainstream ETCO2 measurements...
February 17, 2018: Sleep
https://www.readbyqxmd.com/read/29468194/treatment-of-hiv-infected-individuals-with-the-histone-deacetylase-inhibitor-panobinostat-results-in-increased-numbers-of-regulatory-t-cells-and-limits-ex-vivo-lipopolysaccharide-induced-inflammatory-responses
#4
Christel Rothe Brinkmann, Jesper Falkesgaard Højen, Thomas Aagaard Rasmussen, Anne Sofie Kjær, Rikke Olesen, Paul W Denton, Lars Østergaard, Zhengyu Ouyang, Mathias Lichterfeld, Xu Yu, Ole Schmeltz Søgaard, Charles Dinarello, Martin Tolstrup
Histone deacetylase inhibitors (HDACi) modulate the transcriptional activity of all cells, including innate and adaptive immune cells. Therefore, we aimed to evaluate immunological effects of treatment with the HDACi panobinostat in HIV-infected patients during a clinical phase IIa latency reversal trial. Using flow cytometry, we investigated changes in T cell activation (CD69, CD38, HLA-DR) and the expression of CD39 and CTLA4 on regulatory T cells (Tregs). Whole-blood stimulations were performed and cytokine responses measured using Luminex...
January 2018: MSphere
https://www.readbyqxmd.com/read/29467800/resting-metabolic-rate-of-obese-patients-under-very-low-calorie-ketogenic-diet
#5
Diego Gomez-Arbelaez, Ana B Crujeiras, Ana I Castro, Miguel A Martinez-Olmos, Ana Canton, Lucia Ordoñez-Mayan, Ignacio Sajoux, Cristobal Galban, Diego Bellido, Felipe F Casanueva
Background: The resting metabolic rate (RMR) decrease, observed after an obesity reduction therapy is a determinant of a short-time weight regain. Thus, the objective of this study was to evaluate changes in RMR, and the associated hormonal alterations in obese patients with a very low-calorie ketogenic (VLCK)-diet induced severe body weight (BW) loss. Method: From 20 obese patients who lost 20.2 kg of BW after a 4-months VLCK-diet, blood samples and body composition analysis, determined by DXA and MF-Bioimpedance, and RMR by indirect calorimetry, were obtained on four subsequent visits: visit C-1, basal, initial fat mass (FM) and free fat mass (FFM); visit C-2, - 7...
2018: Nutrition & Metabolism
https://www.readbyqxmd.com/read/29466612/bayesian-enhancement-two-stage-design-for-single-arm-phase-ii-clinical-trials-with-binary-and-time-to-event-endpoints
#6
Haolun Shi, Guosheng Yin
Simon's two-stage design is one of the most commonly used methods in phase II clinical trials with binary endpoints. The design tests the null hypothesis that the response rate is less than an uninteresting level, versus the alternative hypothesis that the response rate is greater than a desirable target level. From a Bayesian perspective, we compute the posterior probabilities of the null and alternative hypotheses given that a promising result is declared in Simon's design. Our study reveals that because the frequentist hypothesis testing framework places its focus on the null hypothesis, a potentially efficacious treatment identified by rejecting the null under Simon's design could have only less than 10% posterior probability of attaining the desirable target level...
February 21, 2018: Biometrics
https://www.readbyqxmd.com/read/29466455/a-pneumatic-bionic-voice-prosthesis-pre-clinical-trials-of-controlling-the-voice-onset-and-offset
#7
Farzaneh Ahmadi, Farzad Noorian, Daniel Novakovic, André van Schaik
Despite emergent progress in many fields of bionics, a functional Bionic Voice prosthesis for laryngectomy patients (larynx amputees) has not yet been achieved, leading to a lifetime of vocal disability for these patients. This study introduces a novel framework of Pneumatic Bionic Voice Prostheses as an electronic adaptation of the Pneumatic Artificial Larynx (PAL) device. The PAL is a non-invasive mechanical voice source, driven exclusively by respiration with an exceptionally high voice quality, comparable to the existing gold standard of Tracheoesophageal (TE) voice prosthesis...
2018: PloS One
https://www.readbyqxmd.com/read/29466366/meta-analysis-of-the-clinical-behavior-of-posterior-direct-resin-restorations-low-polymerization-shrinkage-resin-in-comparison-to-methacrylate-composite-resin
#8
Paula de Castro Kruly, Marcelo Giannini, Renata Corrêa Pascotto, Laíse Midori Tokubo, Uhana Seifert Guimarães Suga, Any de Castro Ruiz Marques, Raquel Sano Suga Terada
Polymerization shrinkage of resin composite can compromise the longevity of restorations. To minimize this problem, the monomeric composition of composites have been modified. The objective of this study was to conduct a meta-analysis to assess the clinical behavior of restorations performed with low polymerization shrinkage resin composite in comparison with traditional methacrylates-based resin composite. This systematic review was registered at Prospero data system (CRD42015023940). Studies were searched in the electronic databases PubMed, Web of Science, Scopus, Lilacs and EMBASE according to a predefined search strategy...
2018: PloS One
https://www.readbyqxmd.com/read/29464757/pelvimetry-in-nulliparous-and-primiparous-women-using-3-tesla-magnetic-resonance-imaging
#9
Franziska Hampel, Peter Hallscheidt, Christof Sohn, Bettina Schlehe, Kerstin A Brocker
AIMS: To perform pelvimetry in nulliparous and primiparous women using 3 Tesla magnetic resonance imaging (3T MRI). METHODS: Twenty-five nulliparous volunteers and 25 primiparous women underwent pelvic 3T MRI within one week after vaginal childbirth in a prospective clinical single-center trial. The pelvimetric parameters interspinous distance (ISD), intertuberous distance (ITD), sagittal outlet (SO), obstetric conjugate (OC), and coccygeal curved length (CCL) were adapted from anthropometric measurements as well as from sonographic and computed tomography-based pelvimetry performed on high-resolution T2-weighted images...
February 21, 2018: Neurourology and Urodynamics
https://www.readbyqxmd.com/read/29463288/reactive-community-based-self-administered-treatment-against-residual-malaria-transmission-study-protocol-for-a-randomized-controlled-trial
#10
Joseph Okebe, Joan Muela Ribera, Julie Balen, Fatou Jaiteh, Yoriko Masunaga, Davis Nwakanma, John Bradley, Shunmay Yeung, Koen Peeters Grietens, Umberto D'Alessandro
BACKGROUND: Systematic treatment of all individuals living in the same compound of a clinical malaria case may clear asymptomatic infections and possibly reduce malaria transmission, where this is focal. High and sustained coverage is extremely important and requires active community engagement. This study explores a community-based approach to treating malaria case contacts. METHODS/DESIGN: This is a cluster-randomized trial to determine whether, in low-transmission areas, treating individuals living in the same compound of a clinical malaria case with dihydroartemisinin-piperaquine can reduce parasite carriage and thus residual malaria transmission...
February 20, 2018: Trials
https://www.readbyqxmd.com/read/29463246/next-generation-personalised-model-based-critical-care-medicine-a-state-of-the-art-review-of-in-silico-virtual-patient-models-methods-and-cohorts-and-how-to-validation-them
#11
REVIEW
J Geoffrey Chase, Jean-Charles Preiser, Jennifer L Dickson, Antoine Pironet, Yeong Shiong Chiew, Christopher G Pretty, Geoffrey M Shaw, Balazs Benyo, Knut Moeller, Soroush Safaei, Merryn Tawhai, Peter Hunter, Thomas Desaive
Critical care, like many healthcare areas, is under a dual assault from significantly increasing demographic and economic pressures. Intensive care unit (ICU) patients are highly variable in response to treatment, and increasingly aging populations mean ICUs are under increasing demand and their cohorts are increasingly ill. Equally, patient expectations are growing, while the economic ability to deliver care to all is declining. Better, more productive care is thus the big challenge. One means to that end is personalised care designed to manage the significant inter- and intra-patient variability that makes the ICU patient difficult...
February 20, 2018: Biomedical Engineering Online
https://www.readbyqxmd.com/read/29458960/challenging-standard-of-care-paradigms-in-the-precision-oncology-era
#12
REVIEW
Vivek Subbiah, Razelle Kurzrock
The pace of genomic and immunological breakthroughs in oncology is accelerating, making it likely that large randomized trials will increasingly become outdated before their completion. Traditional clinical research/practice paradigms must adapt to the reality unveiled by genomics, especially the need for customized drug combinations, rather than one-size-fits-all monotherapy. The raison-d'être of precision oncology is to offer 'the right drug for the right patient at the right time', a process enabled by transformative tissue and blood-based genomic technologies...
February 2018: Trends in Cancer
https://www.readbyqxmd.com/read/29454854/erk1-2-inhibitors-new-weapons-to-inhibit-the-ras-regulated-raf-mek1-2-erk1-2-pathway
#13
REVIEW
Andrew M Kidger, James Sipthorp, Simon J Cook
The RAS-regulated RAF-MEK1/2-ERK1/2 signalling pathway is de-regulated in a variety of cancers due to mutations in receptor tyrosine kinases (RTKs), negative regulators of RAS (such as NF1) and core pathway components themselves (RAS, BRAF, CRAF, MEK1 or MEK2). This has driven the development of a variety of pharmaceutical agents to inhibit RAF-MEK1/2-ERK1/2 signalling in cancer and both RAF and MEK inhibitors are now approved and used in the clinic. There is now much interest in targeting at the level of ERK1/2 for a variety of reasons...
February 15, 2018: Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29454351/disparate-compensation-policies-for-research-related-injury-in-an-era-of-multinational-trials-a-case-study-of-brazil-russia-india-china-and-south-africa
#14
George Rugare Chingarande, Keymanthri Moodley
BACKGROUND: Compensation for research related injuries is a subject that is increasingly gaining traction in developing countries which are burgeoning destinations of multi center research. However, the existence of disparate compensation rules violates the ethical principle of fairness. The current paper presents a comparison of the policies of Brazil, Russia, India, China and South Africa (BRICS). METHODS: A systematic search of good clinical practice guidelines was conducted employing search strategies modeled in line with the recommendations of ADPTE Collaboration (2007)...
February 17, 2018: BMC Medical Ethics
https://www.readbyqxmd.com/read/29453496/influence-of-surface-treatment-on-the-performance-of-silorane-based-composite-resin-in-class-i-restorations-a-randomized-clinical-trial
#15
Isabella Pereira Marques, Fabíola Belkiss Santos de Oliveira, João Gabriel Silva Souza, Raquel Conceição Ferreira, Claudia Silami Magalhães, Fabiana Mantovani Gomes França, Daniela Araújo Veloso Popoff
OBJECTIVES: The aim of this study was to evaluate the clinical performance of silorane-based composite restorations applied after different surface treatments. MATERIALS AND METHODS: This controlled and randomized clinical trial included 26 patients with class I restoration indications. The teeth were randomly assigned to the following treatments: control 1/G1, silorane specific self-etching adhesive (P90 self-etch primer and bond) + silorane-based composite resin (Filtek™ P90 low shrink posterior restorative); G2, 37% phosphoric acid + silorane specific self-etching adhesive + silorane-based composite resin; G3, blasting with aluminum oxide + silorane specific self-etching adhesive + silorane-based composite resin; and control 2/G4, self-etching adhesive (Adper™ SE Plus self-etch adhesive) + dimethacrylate-based composite resin (Filtek™ P60 posterior restorative)...
February 16, 2018: Clinical Oral Investigations
https://www.readbyqxmd.com/read/29453191/a-text-message-intervention-with-adaptive-goal-support-to-reduce-alcohol-consumption-among-non-treatment-seeking-young-adults-non-randomized-clinical-trial-with-voluntary-length-of-enrollment
#16
Brian Suffoletto, Tammy Chung, Frederick Muench, Peter Monti, Duncan B Clark
BACKGROUND: Stand-alone text message-based interventions can reduce binge drinking episodes (≥4 drinks for women and ≥5 drinks for men) among nontreatment-seeking young adults, but may not be optimized. Adaptive text message support could enhance effectiveness by assisting context-specific goal setting and striving, but it remains unknown how to best integrate it into text message interventions. OBJECTIVE: The objective of this study was to evaluate young adults' engagement with a text message intervention, Texting to Reduce Alcohol Consumption 2 (TRAC2), which focuses on reducing weekend alcohol consumption...
February 16, 2018: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/29453101/can-higher-training-practice-dosage-with-treadmill-slip-perturbation-necessarily-reduce-risk-of-falls-following-overground-slip
#17
Anna Lee, Tanvi Bhatt, Xuan Liu, Yiru Wang, Yi-Chung Pai
BACKGROUND: Perturbation training is an emerging paradigm to reduce idiopathic falls (without clinical signs or symptoms) in older adults. While a higher threat dosage (intensity) in motor learning often directly relates to greater adaptation, retention, and generalization, little is known whether increasing the practice dosage (repetition) of slip-perturbation training would necessarily improve its outcomes. RESEARCH QUESTION: Can higher practice dosage of treadmill slip-perturbation training lead to greater generalization to an overground slip immediately after the training? METHODS: Forty-five community-dwelling older adults (73...
February 13, 2018: Gait & Posture
https://www.readbyqxmd.com/read/29452985/effectiveness-of-two-home-ergonomic-programs-in-reducing-pain-and-enhancing-quality-of-life-in-informal-caregivers-of-post-stroke-patients-a-pilot-randomized-controlled-clinical-trial
#18
Karen Lucia de Araújo Freitas Moreira, Gracia María Ábalos-Medina, Carmen Villaverde-Gutiérrez, Neide María Gomes de Lucena, Anderson Belmont Correia de Oliveira, José Manuel Pérez-Mármol
BACKGROUND: Informal caregivers of post-stroke patients usually undergo high levels of pain and stress and have a reduced quality of life. OBJECTIVE: To evaluate the effectiveness of two home ergonomic interventions aimed at reducing pain intensity and perceived stress and enhancing the quality of life in informal caregivers of chronic post-stroke patients. METHODS: A randomized single-blind controlled clinical trial was conducted, with a sample of 33 informal caregivers of patients with stroke...
February 13, 2018: Disability and Health Journal
https://www.readbyqxmd.com/read/29451470/use-of-integrated-clinical-trial-protocols-a-survey-in-early-medicines-development
#19
Katharina Erb-Zohar, Hildegard Sourgens, Kerstin Breithaupt-Groegler
PURPOSE: To collect information on the use of integrated protocols in early clinical medicines development. MATERIALS AND METHODS: The questionnaire was mailed in fall 2014 to members of human pharmacology societies in Europe for anonymous responses via the online tool SurveyMonkey®. RESULTS: 97 respondents reported on 164 integrated protocols overall. In general, integrated protocols comprised 2 or 3 trial elements. One third of integrated protocols involved patients...
February 16, 2018: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29450524/effect-of-a-quality-improvement-intervention-on-clinical-outcomes-in-patients-in-india-with-acute-myocardial-infarction-the-acs-quik-randomized-clinical-trial
#20
Mark D Huffman, Padinhare P Mohanan, Raji Devarajan, Abigail S Baldridge, Dimple Kondal, Lihui Zhao, Mumtaj Ali, Mangalath N Krishnan, Syam Natesan, Rajesh Gopinath, Sunitha Viswanathan, Joseph Stigi, Johny Joseph, Somanathan Chozhakkat, Donald M Lloyd-Jones, Dorairaj Prabhakaran
Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India. Objective: To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state. Design, Setting, and Participants: Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016...
February 13, 2018: JAMA: the Journal of the American Medical Association
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