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adaptive clinical trials

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https://www.readbyqxmd.com/read/28453861/functional-lung-avoidance-and-response-adaptive-escalation-flare-rt-multimodality-plan-dosimetry-of-a-precision-radiation-oncology-strategy
#1
Eunsin Lee, Jing Zeng, Robert S Miyaoka, Jatinder Saini, Paul E Kinahan, George A Sandison, Tony Wong, Hubert J Vesselle, Ramesh Rengan, Stephen R Bowen
PURPOSE: Non-small cell lung cancer (NSCLC) patient radiation therapy (RT) is planned without consideration of spatial heterogeneity in lung function or tumor response. We assessed the dosimetric and clinical feasibility of functional lung avoidance and response-adaptive escalation (FLARE) RT to reduce dose to [(99m) Tc]MAA-SPECT/CT perfused lung while redistributing an escalated boost dose within [(18) F]FDG-PET/CT-defined biological target volumes (BTV). METHODS: Eight stage IIB-IIIB NSCLC patients underwent FDG-PET/CT and MAA-SPECT/CT treatment planning scans...
April 28, 2017: Medical Physics
https://www.readbyqxmd.com/read/28453376/control-of-the-unfolded-protein-response-in-health-and-disease
#2
Dimitrios Doultsinos, Tony Avril, Stéphanie Lhomond, Nicolas Dejeans, Philippe Guédat, Eric Chevet
The unfolded protein response (UPR) is an integrated, adaptive biochemical process that is inextricably linked with cell homeostasis and paramount to maintenance of normal physiological function. Prolonged accumulation of improperly folded proteins in the endoplasmic reticulum (ER) leads to stress. This is the driving stimulus behind the UPR. As such, prolonged ER stress can push the UPR past beneficial functions such as reduced protein production and increased folding and clearance to apoptotic signaling. The UPR is thus contributory to the commencement, maintenance, and exacerbation of a multitude of disease states, making it an attractive global target to tackle conditions sorely in need of novel therapeutic intervention...
April 1, 2017: SLAS Discovery
https://www.readbyqxmd.com/read/28448684/statistical-modeling-for-bayesian-extrapolation-of-adult-clinical-trial-information-in-pediatric-drug-evaluation
#3
Margaret Gamalo-Siebers, Jasmina Savic, Cynthia Basu, Xin Zhao, Mathangi Gopalakrishnan, Aijun Gao, Guochen Song, Simin Baygani, Laura Thompson, H Amy Xia, Karen Price, Ram Tiwari, Bradley P Carlin
Children represent a large underserved population of "therapeutic orphans," as an estimated 80% of children are treated off-label. However, pediatric drug development often faces substantial challenges, including economic, logistical, technical, and ethical barriers, among others. Among many efforts trying to remove these barriers, increased recent attention has been paid to extrapolation; that is, the leveraging of available data from adults or older age groups to draw conclusions for the pediatric population...
April 27, 2017: Pharmaceutical Statistics
https://www.readbyqxmd.com/read/28448374/characteristics-and-correlates-of-caregivers-perceptions-of-their-family-members-memory-loss
#4
Hairong Yu, Jennifer H Lingler, Susan M Sereika, Judith A Erlen
BACKGROUND: Understanding caregiver's perceptions of their family member's memory loss is a necessary step in planning nursing interventions to detect and address caregiver burden. OBJECTIVE: The purpose of this study was to characterize caregivers' perceptions of their family members' memory loss and identify potential correlates within Leventhal's common sense model (CSM). METHODS: This secondary analysis used baseline data from a larger randomized controlled trial...
May 2017: Nursing Research
https://www.readbyqxmd.com/read/28447664/efficient-design-of-clinical-trials-and-epidemiological-research-is-it-possible
#5
REVIEW
Michael S Lauer, David Gordon, Gina Wei, Gail Pearson
Randomized clinical trials and large-scale, cohort studies continue to have a critical role in generating evidence in cardiovascular medicine; however, the increasing concern is that ballooning costs threaten the clinical trial enterprise. In this Perspectives article, we discuss the changing landscape of clinical research, and clinical trials in particular, focusing on reasons for the increasing costs and inefficiencies. These reasons include excessively complex design, overly restrictive inclusion and exclusion criteria, burdensome regulations, excessive source-data verification, and concerns about the effect of clinical research conduct on workflow...
April 27, 2017: Nature Reviews. Cardiology
https://www.readbyqxmd.com/read/28446232/continuous-quality-improvement-interventions-to-improve-long-term-outcomes-of-antiretroviral-therapy-in-women-who-initiated-therapy-during-pregnancy-or-breastfeeding-in-the-democratic-republic-of-congo-design-of-an-open-label-parallel-group-randomized-trial
#6
Marcel Yotebieng, Frieda Behets, Bienvenu Kawende, Noro Lantoniaina Rosa Ravelomanana, Martine Tabala, Emile W Okitolonda
BACKGROUND: Despite the rapid adoption of the World Health Organization's 2013 guidelines, children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health (MCH) clinics. To achieve the UNAIDS goal of eliminating mother-to-child HIV transmission, multiple, adaptive interventions need to be implemented to improve adherence to the HIV continuum. METHODS: The aim of this open label, parallel, group randomized trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district levels to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo...
April 26, 2017: BMC Health Services Research
https://www.readbyqxmd.com/read/28445142/potential-biomarkers-of-dna-replication-stress-in-cancer
#7
Liqun Ren, Long Chen, Wei Wu, Lorenza Garribba, Huanna Tian, Zihui Liu, Ivan Vogel, Chunhui Li, Ian D Hickson, Ying Liu
Oncogene activation is an established driver of tumorigenesis. An apparently inevitable consequence of oncogene activation is the generation of DNA replication stress (RS), a feature common to most cancer cells. RS, in turn, is a causal factor in the development of chromosome instability (CIN), a near universal feature of solid tumors. It is likely that CIN and RS are mutually reinforcing drivers that not only accelerate tumorigenesis, but also permit cancer cells to adapt to diverse and hostile environments...
April 7, 2017: Oncotarget
https://www.readbyqxmd.com/read/28444695/exercise-therapy-for-chronic-fatigue-syndrome
#8
REVIEW
Lillebeth Larun, Kjetil G Brurberg, Jan Odgaard-Jensen, Jonathan R Price
BACKGROUND: Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. OBJECTIVES: The objective of this review was to determine the effects of exercise therapy (ET) for patients with CFS as compared with any other intervention or control...
April 25, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28444204/murine-models-of-sepsis-and-trauma-can-we-bridge-the-gap
#9
Julie A Stortz, Steven L Raymond, Juan C Mira, Lyle L Moldawer, Alicia M Mohr, Philip A Efron
Sepsis and trauma are both leading causes of death in the United States and represent major public health challenges. Murine models have largely been used in sepsis and trauma research to better understand the pathophysiological changes that occur after an insult and to develop potential life-saving therapeutic agents. Mice are favorable subjects for this type of research given the variety of readily available strains including inbred, outbred, and transgenic strains. In addition, they are relatively easy to maintain and have a high fecundity...
April 21, 2017: ILAR Journal
https://www.readbyqxmd.com/read/28443099/a-century-of-radiation-therapy-and-adaptive-immunity
#10
REVIEW
Dörthe Schaue
The coming of age for immunotherapy (IT) as a genuine treatment option for cancer patients through the development of new and effective agents, in particular immune checkpoint inhibitors, has led to a huge renaissance of an old idea, namely to harness the power of the immune system to that of radiation therapy (RT). It is not an overstatement to say that the combination of RT with IT has provided a new conceptual platform that has re-energized the field of radiation oncology as a whole. One only has to look at the immense rise in sessions at professional conferences and in grant applications dealing with this topic to see its emergence as a force, while the number of published reviews on the topic is staggering...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28443068/evaluation-of-the-probiotic-strain-bifidobacterium-longum-subsp-infantis-cect-7210-capacities-to-improve-health-status-and-fight-digestive-pathogens-in-a-piglet-model
#11
Emili Barba-Vidal, Lorena Castillejos, Paola López-Colom, Montserrat Rivero Urgell, José A Moreno Muñoz, Susana M Martín-Orúe
Probiotics have been demonstrated to be useful to enhance gut health and prevent gastrointestinal infections. The objective of this study is to demonstrate the potential of the probiotic strain Bifidobacterium longum subsp. infantis CECT 7210 (B. infantis IM1) to prevent and fight intestinal disease by using a Salmonella Typhimurium (Trial 1) or an enterotoxigenic Escherichia coli K88 (Trial 2) oral challenge in a weaning piglet model. Seventy-two piglets were used in each trial. After an adaptation period, animals were orally challenged...
2017: Frontiers in Microbiology
https://www.readbyqxmd.com/read/28441974/evaluating-effectiveness-and-cost-effectiveness-of-a-group-psychological-intervention-using-cognitive-behavioural-strategies-for-women-with-common-mental-disorders-in-conflict-affected-rural-pakistan-study-protocol-for-a-randomised-controlled-trial
#12
Anna Chiumento, Syed Usman Hamdani, Muhammad Naseem Khan, Katie Dawson, Richard A Bryant, Marit Sijbrandij, Huma Nazir, Parveen Akhtar, Aqsa Masood, Duolao Wang, Mark van Ommeren, Atif Rahman
BACKGROUND: The impact of humanitarian disasters upon mental health is well recognised. The evidence for psychological interventions for mental health is mounting, but few interventions have been rigorously tested in humanitarian settings. To be sustainable in humanitarian settings interventions need to be short, simple, deliverable by nonspecialists under supervision, and adopt a transdiagnostic approach where an array of mental health outcomes are addressed simultaneously. These elements have been incorporated into the newly developed WHO Problem Management Plus (PM+) Group intervention...
April 26, 2017: Trials
https://www.readbyqxmd.com/read/28440861/findings-from-the-families-on-track-intervention-pilot-trial-for-children-with-fetal-alcohol-spectrum-disorders-and-their-families
#13
Christie L M Petrenko, Mary E Pandolfino, Luther K Robinson
BACKGROUND: Individuals with fetal alcohol spectrum disorders (FASD) are at high risk for costly, debilitating mental health problems and secondary conditions, such as school disruption, trouble with the law, and substance use. The study objective was to pilot a multi-component intervention designed to prevent secondary conditions in children with FASD and improve family adaptation. METHODS: Thirty children with FASD or prenatal alcohol exposure (PAE) (ages 4 to 8) and their primary caregivers were enrolled...
April 25, 2017: Alcoholism, Clinical and Experimental Research
https://www.readbyqxmd.com/read/28440024/immediate-and-delayed-loading-of-two-piece-reduced-diameter-implants-with-locator-analog-attachments-in-edentulous-mandibles-one-year-results-from-a-randomized-clinical-trial-examining-clinical-outcome-and-patient-expectation
#14
Nikolaos Nikitas Giannakopoulos, Kirsten Ariaans, Lydia Eberhard, Anna-Luisa Klotz, Keunyoung Oh, Stefanie Kappel
BACKGROUND: Prosthetic management of thin alveolar ridges in the edentulous mandibles of elderly patients, especially the time of loading, the number of implants needed, and patient expectations and perception, is a challenge in implant dentistry. PURPOSE: Survival of conventionally and immediately loaded 2-piece reduced-diameter implants in the interforaminal region of the edentulous mandible supporting locator-analog attachments was evaluated. Prosthetic complications and peri-implant hygiene were also studied, and patient expectation and subjective evaluation of the treatment were documented...
April 24, 2017: Clinical Implant Dentistry and related Research
https://www.readbyqxmd.com/read/28437147/comparison-of-two-types-of-meditation-on-patients-psychosocial-responses-during-radiation-therapy-for-head-and-neck-cancer
#15
Gisela Boxleitner, Shelley Jolie, Dana Shaffer, Nicholas Pasacreta, Mei Bai, Ruth McCorkle
OBJECTIVES: Radiation treatment for head and neck cancer introduces adaptive demands and subjects patients to significant and unique psychosocial challenges. There is growing evidence that meditation is useful in lessening anxiety and depression in cancer patients. This study compared the effects of two types of meditation training on the psychological responses of patients with head and neck cancer during radiation therapy. DESIGN: Randomized clinical trial. SETTING: Smilow Cancer Hospital at Yale New Haven...
February 17, 2017: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
https://www.readbyqxmd.com/read/28436756/the-role-of-attachment-style-in-interpersonal-psychotherapy-for-depressed-adolescents
#16
Meredith Gunlicks-Stoessel, Ana Westervelt, Kristina Reigstad, Laura Mufson, Susanne Lee
OBJECTIVE(S): This study examined changes in depressed adolescents' reports of attachment anxiety and avoidance with interpersonal psychotherapy (IPT-A), and the relationship between attachment style and change in depression with IPT-A. METHOD: Forty adolescents (aged 12-17) participated in a 16-week randomized clinical trial of 4 adaptive treatment strategies for adolescent depression that began with IPT-A and augmented treatment for insufficient responders (n = 22) by adding additional IPT-A sessions (n = 11) or the antidepressant medication, fluoxetine (n = 11)...
April 24, 2017: Psychotherapy Research: Journal of the Society for Psychotherapy Research
https://www.readbyqxmd.com/read/28434375/the-role-of-adaptive-trial-designs-in-drug-development
#17
François Curtin, Stephane Heritier
Clinical development of new drugs is a long and costly process. There is a need to find solutions which can improve and shorten this process. By introducing flexibility in to the design of clinical trials, adaptive design contributes to this improvement and allows to reach drug development decisions in a quicker way. Areas covered: We review the main methodological approaches to adaptive trial design, introducing key statistical concepts. For each phase of the clinical development, different uses and implementations of adaptive trial (AD) design are presented and examples of recent clinical trials are given...
April 24, 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28434112/dendritic-cell-based-vaccination-strategy-an-evolving-paradigm
#18
REVIEW
Anna C Filley, Mahua Dey
Malignant gliomas (MG), tumors of glial origin, are the most commonly diagnosed primary intracranial malignancies in adults. Currently available treatments have provided only modest improvements in overall survival and remain limited by inevitable local recurrence, necessitating exploration of novel therapies. Among approaches being investigated, one of the leading contenders is immunotherapy, which aims to modulate immune pathways to stimulate the selective destruction of malignant cells. Dendritic cells (DCs) are potent initiators of adaptive immune responses and therefore crucial players in the development and success of immunotherapy...
April 22, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28433091/internet-delivered-parenting-program-for-prevention-and-early-intervention-of-anxiety-problems-in-young-children-randomized-controlled-trial
#19
Amy J Morgan, Ronald M Rapee, Agus Salim, Nahal Goharpey, Elli Tamir, Lauren F McLellan, Jordana K Bayer
OBJECTIVE: The Cool Little Kids parenting group program is an effective intervention for preventing anxiety disorders in young children who are at risk because of inhibited temperament. The program has six group sessions delivered by trained psychologists to parents of 3- to 6-year-old children. An online adaptation (Cool Little Kids Online) has been developed to overcome barriers to its wide dissemination in the community. This study tested the efficacy of Cool Little Kids Online in a randomized controlled trial...
May 2017: Journal of the American Academy of Child and Adolescent Psychiatry
https://www.readbyqxmd.com/read/28432578/a-randomized-controlled-trial-of-rise-a-community-based-culturally-congruent-adherence-intervention-for-black-americans-living-with-hiv
#20
Laura M Bogart, Matt G Mutchler, Bryce McDavitt, David J Klein, William E Cunningham, Kathy J Goggin, Bonnie Ghosh-Dastidar, Nikki Rachal, Kelsey A Nogg, Glenn J Wagner
BACKGROUND: Evidence-based HIV treatment adherence interventions have typically shown medium-sized effects on adherence. Prior evidence-based HIV treatment adherence interventions have not been culturally adapted specifically for Black/African Americans, the population most affected by HIV disparities in the USA, who exhibit lower adherence than do members of other racial/ethnic groups. PURPOSE: We conducted a randomized controlled trial of Rise, a 6-month culturally congruent adherence counseling intervention for HIV-positive Black men and women...
April 21, 2017: Annals of Behavioral Medicine: a Publication of the Society of Behavioral Medicine
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