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adaptive clinical trials

Annika Clamor, Julian Koenig, Julian F Thayer, Tania M Lincoln
Arousal and the way it is coped with are relevant to the emergence of psychotic symptoms. Heart rate variability (HRV) stems from autonomic responses to environmental demands such as stress and is an index of physiological arousal, adaptability, and homeostatic reflexes forming autonomic balance. A randomized-controlled between-subjects trial that compared HRV-biofeedback (BF) to an active relaxation and to a waiting control condition was conducted in a sample with attenuated subclinical psychotic symptoms (N = 84)...
October 11, 2016: Behaviour Research and Therapy
Michelle A Giuffrida
OBJECTIVE To evaluate methods used to ascertain, define, and report adverse events (AEs) in companion animal clinical trials involving cancer treatment. DESIGN Systematic review. SAMPLE English-language articles describing prospective clinical trials involving dogs and cats with naturally occurring cancer published in peer-reviewed journals between 2008 and 2014. PROCEDURES Reports were identified via MEDLINE and CAB database searches combined with a hand-searching strategy. General article characteristics were abstracted and summarized...
November 1, 2016: Journal of the American Veterinary Medical Association
Margaret L Salisbury, David A Lynch, Edwin J R van Beek, Ella A Kazerooni, Junfeng Guo, Meng Xia, Susan Murray, Kevin J Anstrom, Eric Yow, Fernando J Martinez, Eric A Hoffman, Kevin R Flaherty
RATIONALE: Adaptive Multiple Features Method (AMFM) lung texture analysis software recognizes high-resolution computed tomography (HRCT) patterns. OBJECTIVES: We evaluated AMFM and visual quantification of HRCT patterns and their relationship with disease progression in Idiopathic Pulmonary Fibrosis. METHODS: IPF patients in a clinical trial of prednisone, azathioprine, and N-acetylcysteine underwent HRCT at study start and finish. Proportion of lung occupied by ground glass, ground glass-reticular (GGR), honeycombing, emphysema, and normal were measured by AMFM and 3 radiologists, documenting baseline disease extent and post-baseline change...
October 21, 2016: American Journal of Respiratory and Critical Care Medicine
Yin J Wong
Data sourcesThe Cochrane Database of Systematic Reviews on the Cochrane Library.Study selectionAll Cochrane reviews of RCTs between 1999 to 2015, conducted in adults examining the adverse events associated with single dose oral analgesics used for acute post-operative pain were considered.Data extraction and synthesisStudies were searched, reviewed and assessed independently by two reviewers and standard data items extracted. Methodological quality was assessed using criteria adapted from AMSTAR (Assessing the Methodological Quality of Systematic Reviews)...
September 2016: Evidence-based Dentistry
W Schuyler Jones, Matthew T Roe, Elliott M Antman, Mark J Pletcher, Robert A Harrington, Russell L Rothman, William J Oetgen, Sunil V Rao, Mitchell W Krucoff, Lesley H Curtis, Adrian F Hernandez, Frederick A Masoudi
Large randomized clinical trials in cardiovascular disease have proliferated over the past 3 decades, with results that have influenced every aspect of cardiology practice. Despite these advances, there remains a substantial need for more high-quality evidence to inform cardiovascular clinical practice, given the increasing prevalence of cardiovascular disease around the world. Traditional clinical trials are increasingly challenging due to rising costs, increasing complexity and length, and burdensome institutional and regulatory requirements...
October 25, 2016: Journal of the American College of Cardiology
Kosuke Toda, Kenji Kawada, Masayoshi Iwamoto, Susumu Inamoto, Takehiko Sasazuki, Senji Shirasawa, Suguru Hasegawa, Yoshiharu Sakai
A number of clinical trials have shown that KRAS mutations of colorectal cancer (CRC) can predict a lack of responses to anti-epidermal growth factor receptor-based therapy. Recently, there have been several studies to elucidate metabolism reprogramming in cancer. However, it remains to be investigated how mutated KRAS can coordinate the metabolic shift to sustain CRC tumor growth. In this study, we found that KRAS mutation in CRC caused alteration in amino acid metabolism. KRAS mutation causes a marked decrease in aspartate level and an increase in asparagine level in CRC...
October 17, 2016: Neoplasia: An International Journal for Oncology Research
Rafael E Pedro, Débora A Guariglia, Sidney B Peres, Solange M Moraes
BACKGROUND: Human immunodeficiency virus-associated lipodystrophy syndrome (HALS) is a major problem among people living with HIV/aids. The exercise training has been used for its treatment; however, the knowledge about benefits and safety still is emerging. The aim was systematically review the literature for physiological, metabolic, immunologic, and morphologic adaptations to aerobic, resistance, and concurrent training in people living with HALS. METHODS: A search of the Medline, Embase, Cinahl, Lilacs, Scielo, Web of Science, the Cochrane Controlled Trials Register Library and PEDro was performed...
October 20, 2016: Journal of Sports Medicine and Physical Fitness
Geerte C Den Hollander, Joyce L Browne, Daniel Arhinful, Rieke van der Graaf, Kerstin Klipstein-Grobusch
To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana...
October 20, 2016: Developing World Bioethics
V E Radzinskii, I V Kuznetsova, Y B Uspenskaya, N B Repina, Y K Gusak, O M Zubova, D I Burchakov, A A Osmakova
Peri- and postmenopausal women commonly suffer from climacteric symptoms. We evaluated the effectiveness and safety of dietary supplement Amberen to relieve vasomotor and psychosomatic symptoms during the course of a 3-month, randomized, double-blind, placebo-controlled study. General clinical assessment, evaluation using the Greene climacteric test and Spielberger-Hanin test, determination of plasma levels of gonadotropins, estradiol, leptin and apolipoproteins were used to evaluate 42-60-year-old women with vasomotor and psychosomatic menopausal symptoms...
October 2016: Gynecological Endocrinology
J D Huntley, A Hampshire, D Bor, A Owen, R J Howard
BACKGROUND: Interventions that improve cognitive function in Alzheimer's disease are urgently required. AIMS: To assess whether a novel cognitive training paradigm based on 'chunking' improves working memory and general cognitive function, and is associated with reorganisation of functional activity in prefrontal and parietal cortices (trial registration: ISRCTN43007027). METHOD: Thirty patients with mild Alzheimer's disease were randomly allocated to receive 18 sessions of 30 min of either adaptive chunking training or an active control intervention over approximately 8 weeks...
October 6, 2016: British Journal of Psychiatry: the Journal of Mental Science
Erika Vacchelli, Norma Bloy, Fernando Aranda, Aitziber Buqué, Isabelle Cremer, Sandra Demaria, Alexander Eggermont, Silvia Chiara Formenti, Wolf Hervé Fridman, Jitka Fucikova, Jérôme Galon, Radek Spisek, Eric Tartour, Laurence Zitvogel, Guido Kroemer, Lorenzo Galluzzi
Malignant cells succumbing to some forms of radiation therapy are particularly immunogenic and hence can initiate a therapeutically relevant adaptive immune response. This reflects the intrinsic antigenicity of malignant cells (which often synthesize a high number of potentially reactive neo-antigens) coupled with the ability of radiation therapy to boost the adjuvanticity of cell death as it stimulates the release of endogenous adjuvants from dying cells. Thus, radiation therapy has been intensively investigated for its capacity to improve the therapeutic profile of several anticancer immunotherapies, including (but not limited to) checkpoint blockers, anticancer vaccines, oncolytic viruses, Toll-like receptor (TLR) agonists, cytokines, and several small molecules with immunostimulatory effects...
2016: Oncoimmunology
Laura M Gault, Robert A Lenz, Craig W Ritchie, Andreas Meier, Ahmed A Othman, Qi Tang, Scott Berry, Yili Pritchett, Weining Z Robieson
BACKGROUND: Results from a phase 2a study indicated that treatment with the novel α7 nicotinic acetylcholine receptor agonist ABT-126 25 mg once daily (QD) was associated with a trend for improvement in cognition in subjects with mild-to-moderate Alzheimer's dementia (AD). A phase 2b program was designed to evaluate a broader dose range of ABT-126 as monotherapy in subjects with mild-to-moderate AD. The program consisted of a double-blind, placebo and active controlled study of ABT-126 (dose range 25-75 mg) and an open-label extension study (75 mg)...
October 18, 2016: Alzheimer's Research & Therapy
Anne-Segolene Cottereau, Sebastien Hapdey, Loic Chartier, Romain Modzelewski, Olivier Casasnovas, Emmanuel Itti, Herve Tilly, Pierre Vera, Michel A Meignan, Stéphanie Becker
: To compare in a large series of Peripheral T cell lymphoma (PTCL), as a model of diffuse disease, the prognostic value of baseline Total Metabolic Tumor Volume (TMTV) measured on FDG-PET/CT with adaptive thresholding methods to TMTV measured with a fixed 41% SUVmax threshold method. METHODS: 106 patients with PTCL, staged with a PET/CT were enrolled from 5 LYSA centers. In this series TMTV computed with the 41% SUVmax threshold is a strong predictor of outcome (Ann Oncol, 2016)...
October 6, 2016: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
Masatsugu Horiuchi
Hypertensive patients have greater chances of such cardiovascular events as stroke, coronary heart disease, heart or renal failure, peripheral artery disease, and dementia. It is also well recognized that diabetes increases the cardiovascular risks in concert with hypertension. Therefore, main goals for an innovation of anti-hypertensive therapy would be to achieve further risk reduction by targeting the functional, metabolic, and structural alterations associated with hypertension. Professors Dzau and Braunwald et al proposed the concept of "the cardiovascular disease continuum" in 1991, and that hypertension may trigger the chain of events, leading to end-stage heart disease; however, this concept was quite new at that time, and there was some discussion whether "the cardiovascular disease continuum" is true or not...
September 2016: Journal of Hypertension
Jeremy Veenstra-VanderWeele, Edwin H Cook, Bryan H King, Peter Zarevics, Maryann Cherubini, Karen Walton-Bowen, Mark F Bear, Paul P Wang, Randall L Carpenter
Several lines of emerging data point to an imbalance between neuronal excitation and inhibition in at least a subgroup of individuals with autism spectrum disorder (ASD), including in those with fragile X syndrome (FXS), one of the most common genetic syndromes within ASD. In animal models of FXS and of ASD, GABA-B agonists have improved both brain and behavioral phenotypes, including social behavior. A phase 2 randomized, placebo-controlled, crossover trial found that the GABA-B agonist arbaclofen improved social avoidance symptoms in FXS...
October 17, 2016: Neuropsychopharmacology: Official Publication of the American College of Neuropsychopharmacology
Xiaojing Liu, Iris L Romero, Lacey M Litchfield, Ernst Lengyel, Jason W Locasale
Repurposing metformin for cancer therapy is attractive due to its safety profile, epidemiological evidence, and encouraging data from human clinical trials. Although it is known to systemically affect glucose metabolism in liver, muscle, gut, and other tissues, the molecular determinants that predict a patient response in cancer remain unknown. Here, we carry out an integrative metabolomics analysis of metformin action in ovarian cancer. Metformin accumulated in patient biopsies, and pathways involving nucleotide metabolism, redox, and energy status, all related to mitochondrial metabolism, were affected in treated tumors...
October 12, 2016: Cell Metabolism
Jan Pieter Marchal, Heleen Maurice-Stam, Bregje A Houtzager, Susanne L Rutgers van Rozenburg-Marres, Kim J Oostrom, Martha A Grootenhuis, A S Paul van Trotsenburg
BACKGROUND: We analysed developmental outcomes from a clinical trial early in life and its follow-up at 10.7 years in 123 children with Down syndrome. AIMS: To determine 1) strengths and weaknesses in adaptive functioning and motor skills at 10.7 years, and 2) prognostic value of early-life characteristics (early developmental outcomes, parental and child characteristics, and comorbidity) for later intelligence, adaptive functioning and motor skills. METHODS AND PROCEDURES: We used standardized assessments of mental and motor development at ages 6, 12 and 24 months, and of intelligence, adaptive functioning and motor skills at 10...
October 13, 2016: Research in Developmental Disabilities
Dominic Way, Hortense Blazsin, Ragnar Löfstedt, Frederic Bouder
This paper reviews the main tools for communicating benefit-risk medicines information to patients that are used, or could be used, by pharmaceutical regulators. One highly successful tool from the food safety sector (front-of-package traffic-light labelling) and the mental models approach (which provides a framework for developing new tools) are also reviewed as they show great promise for being usefully adapted to the pharmaceutical context. The evolution of benefit-risk medicines communication is first contextualised within the broader risk communication literature...
October 14, 2016: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Amy K Erbe, Wei Wang, Jacob Goldberg, Mikayla Gallenberger, KyungMann Kim, Lakeesha Carmichael, Dustin Hess, Eneida A Mendonca, Yiqiang Song, Jacquelyn A Hank, Su-Chun Cheng, Sabina Signoretti, Michael Atkins, Alexander Carlson, James W Mier, David J Panka, David F McDermott, Paul M Sondel
BACKGROUND: Fc-gamma receptors (FCGRs) are expressed on immune cells, bind to antibodies, and trigger antibody-induced cell-mediated anti-tumor responses when tumor-reactive antibodies are present. The affinity of the FCGR/antibody interaction is variable and dependent upon FCGR polymorphisms. Prior studies of cancer patients treated with immunotherapy indicate that FCGR polymorphisms can influence antitumor response for certain immunotherapies that act via therapeutically administered mAbs or via endogenous tumor-reactive antibodies induced from tumor antigen vaccines...
October 14, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Chiara Cencioni, Sandra Atlante, Matteo Savoia, Fabio Martelli, Antonella Farsetti, Maurizio C Capogrossi, Andreas M Zeiher, Carlo Gaetano, Francesco Spallotta
Organ-specific mesenchymal cells naturally reside in the stroma, where they are exposed to some environmental variables affecting their biology and functions. Risk factors such as diabetes or aging influence their adaptive response. In these cases, permanent epigenetic modifications may be introduced in the cells with important consequences on their local homeostatic activity and therapeutic potential. Numerous results suggest that mesenchymal cells, virtually present in every organ, may contribute to tissue regeneration mostly by paracrine mechanisms...
October 11, 2016: Pharmacology & Therapeutics
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