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Enriched trial design

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https://www.readbyqxmd.com/read/28435450/exome-sequencing-of-oral-squamous-cell-carcinoma-reveals-molecular-subgroups-and-novel-therapeutic-opportunities
#1
Shih-Chi Su, Chiao-Wen Lin, Yu-Fan Liu, Wen-Lang Fan, Mu-Kuan Chen, Chun-Ping Yu, Wei-En Yang, Chun-Wen Su, Chun-Yi Chuang, Wen-Hsiung Li, Wen-Hung Chung, Shun-Fa Yang
Oral squamous cell carcinoma (OSCC), an epithelial malignancy affecting a variety of subsites in the oral cavity, is prevalent in Asia. The survival rate of OSCC patients has not improved over the past decades due to its heterogeneous etiology, genetic aberrations, and treatment outcomes. Improvement in therapeutic strategies and tailored treatment options is an unmet need. To unveil the mutational spectrum, whole-exome sequencing of 120 OSCC from male individuals in Taiwan was conducted. Analyzing the contributions of the five mutational signatures extracted from the dataset of somatic variations identified four groups of tumors that were significantly associated with demographic and clinical features...
2017: Theranostics
https://www.readbyqxmd.com/read/28434208/dietary-interventions-for-adults-with-chronic-kidney-disease
#2
REVIEW
Suetonia C Palmer, Jasjot K Maggo, Katrina L Campbell, Jonathan C Craig, David W Johnson, Bernadet Sutanto, Marinella Ruospo, Allison Tong, Giovanni Fm Strippoli
BACKGROUND: Dietary changes are routinely recommended in people with chronic kidney disease (CKD) on the basis of randomised evidence in the general population and non-randomised studies in CKD that suggest certain healthy eating patterns may prevent cardiovascular events and lower mortality. People who have kidney disease have prioritised dietary modifications as an important treatment uncertainty. OBJECTIVES: This review evaluated the benefits and harms of dietary interventions among adults with CKD including people with end-stage kidney disease (ESKD) treated with dialysis or kidney transplantation...
April 23, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28434163/biomarkers-of-epileptogenesis-the-focus-on-glia-and-cognitive-dysfunctions
#3
Annamaria Vezzani, Rosaria Pascente, Teresa Ravizza
The need to find measures that reliably predict the onset of epilepsy after injurious events or how the patient will respond to anti-seizure drugs led to intensive pre-clinical and clinical research to discover non-invasive biomarkers that could increase the sensitivity of existing clinical indicators. The use of experimental models of epileptogenesis and of drug-resistance is instrumental to select the most promising approaches to explore such biomarkers in the pre-clinical setting for further clinical validation...
April 22, 2017: Neurochemical Research
https://www.readbyqxmd.com/read/28417835/objective-vs-subjective-evaluation-of-cognitive-performance-during-0-4-mpa-dives-breathing-air-or-nitrox
#4
Peter Germonpré, Costantino Balestra, Walter Hemelryck, Peter Buzzacott, Pierre Lafère
BACKGROUND: Divers try to limit risks associated with their sport, for instance by breathing enriched air nitrox (EANx) instead of air. This double blinded, randomized trial was designed to see if the use of EANx could effectively improve cognitive performance while diving. METHODS: Eight volunteers performed two no-decompression dry dives breathing air or EANx for 20 min at 0.4 MPa. Cognitive functions were assessed with a computerized test battery, including MathProc and Ptrail...
May 1, 2017: Aerospace Medicine and Human Performance
https://www.readbyqxmd.com/read/28389248/effects-of-whey-protein-and-its-two-major-protein-components-on-satiety-and-food-intake-in-normal-weight-women
#5
Sylvia M S Chungchunlam, Sharon J Henare, Siva Ganesh, Paul J Moughan
Protein is the most satiating macronutrient and is source dependent, with whey protein thought to be particularly satiating. The purported satiating effect of whey protein may be due to the unique mixture of proteins in whey or to the major constituent individual proteins (β-lactoglobulin and α-lactalbumin). The objective of the study was to compare the effects of isoenergetic (~2100kJ, ~500kcal) preload meals enriched (~50g protein) with either whey protein isolate (WP), β-lactoglobulin (BL) isolate or α-lactalbumin (AL) isolate, on food intake at an ad libitum test meal 120min later and subjective ratings of appetite (hunger, desire to eat, prospective food consumption and fullness) using visual analogue scales (VAS)...
April 4, 2017: Physiology & Behavior
https://www.readbyqxmd.com/read/28374784/targeting-c-met-in-gastrointestinal-tumours-rationale-opportunities-and-challenges
#6
REVIEW
Conor A Bradley, Manuel Salto-Tellez, Pierre Laurent-Puig, Alberto Bardelli, Christian Rolfo, Josep Tabernero, Hajrah A Khawaja, Mark Lawler, Patrick G Johnston, Sandra Van Schaeybroeck
Data from many preclinical studies, including those using cellular models of colorectal, gastric, gastro-oesophageal and gastro-oesophageal junction cancers, indicate that the hepatocyte growth factor (HGF)-hepatocyte growth factor receptor (c-MET) pathway is vital for the growth, survival and invasive potential of gastrointestinal cancers. Following the availability of data from these various studies, and data on c-MET expression as a biomarker that indicates a poor prognosis in patients with gastrointestinal cancer and increased c-MET expression, inhibitors targeting this pathway have entered the clinic in the past decade...
April 4, 2017: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/28360996/the-role-of-cognitive-activity-in-cognition-protection-from-bedside-to-bench
#7
REVIEW
Bin-Yin Li, Ying Wang, Hui-Dong Tang, Sheng-Di Chen
BACKGROUND: Cognitive decline poses a great concern to elderly people and their families. In addition to pharmacological therapies, several varieties of nonpharmacological intervention have been developed. Most training trials proved that a well-organized task is clinically effective in cognition improvement. MAIN BODY: We will first review clinical trials of cognitive training for healthy elders, MCI and AD patients, respectively. Besides, potential neuroprotective and compensatory mechanisms in animal models of AD are discussed...
2017: Translational Neurodegeneration
https://www.readbyqxmd.com/read/28360532/bottlenecks-in-the-development-of-topical-analgesics-molecule-formulation-dose-finding-and-phase-iii-design
#8
REVIEW
Jan M Keppel Hesselink, David J Kopsky, Stephen M Stahl
Topical analgesics can be defined as topical formulations containing analgesics or co-analgesics. Since 2000, interest in such formulations has been on the rise. There are, however, four critical issues in the research and development phases of topical analgesics: 1) The selection of the active pharmaceutical ingredient. Analgesics and co-analgesics differ greatly in their mechanism of action, and it is required to find the most optimal fit between such mechanisms of action and the pathogenesis of the targeted (neuropathic) pain...
2017: Journal of Pain Research
https://www.readbyqxmd.com/read/28329240/effect-of-breathing-oxygen-enriched-air-on-exercise-performance-in-patients-with-precapillary-pulmonary-hypertension-randomized-sham-controlled-cross-over-trial
#9
Silvia Ulrich, Elisabeth D Hasler, Stéphanie Saxer, Michael Furian, Séverine Müller-Mottet, Stephan Keusch, Konrad E Bloch
Aims: The purpose of the current trial was to test the hypothesis that breathing oxygen-enriched air increases exercise performance of patients with pulmonary arterial or chronic thrombo-embolic pulmonary hypertension (PAH/CTEPH) and to investigate involved mechanisms. Methods and results: Twenty-two patients with PAH/CTEPH, eight women, means ± SD 61 ± 14 years, resting mPAP 35 ± 9mmHg, PaO2 ambient air >7.3 kPa, underwent four bicycle ergospirometries to exhaustion on different days, while breathing oxygen-enriched (FiO2 0...
April 14, 2017: European Heart Journal
https://www.readbyqxmd.com/read/28327926/genomic-characterisation-of-her2-positive-breast-cancer-and-response-to-neoadjuvant-trastuzumab-and-chemotherapy-results-from-the-acosog-z1041-alliance-trial
#10
R Lesurf, O L Griffith, M Griffith, J Hundal, L Trani, M A Watson, R Aft, M J Ellis, D Ota, V J Suman, F Meric-Bernstam, A M Leitch, J C Boughey, G Unzeitig, A U Buzdar, K K Hunt, E R Mardis
Background: HER2 ( ERBB2 ) gene amplification and its corresponding overexpression are present in 15-30% of invasive breast cancers. While HER2-targeted agents are effective treatments, resistance remains a major cause of death. The American College of Surgeons Oncology Group Z1041 trial (NCT00513292) was designed to compare the pathologic complete response (pCR) rate of distinct regimens of neoadjuvant chemotherapy and trastuzumab, but ultimately identified no difference [1]. Patients and methods: In supplement to tissues from 37 Z1041 cases, 11 similarly treated cases were obtained from a single institution study (NCT00353483)...
February 21, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28325150/managing-expectations-in-the-transition-to-proof-of-concept-studies
#11
Thomas Kieber-Emmons, Issam Makhoul, Angela Pennisi, Eric R Siegel, Peter D Emanuel, Bejotaloh Monzavi-Karbassi, Zenon Steplewski, J Thaddeus Beck, Laura F Hutchins
BACKGROUND: As we are moving away from the traditional chemotherapy era to targeted therapy, the validity of old assessment paradigms associated with therapeutics are being raised in the context of immunotherapy. The old paradigm required elaborate assessment of toxicity with no expectation of efficacy in early phase trials. Safety data from Phase 1 and 2 studies with many immunotherapeutics show that they display limited toxicities and draw attention to the need to demonstrate efficacy in the early evaluation of new agents...
March 21, 2017: Reviews on Recent Clinical Trials
https://www.readbyqxmd.com/read/28321893/dose-finding-methods-for-phase-i-clinical-trials-using-pharmacokinetics-in-small-populations
#12
Moreno Ursino, Sarah Zohar, Frederike Lentz, Corinne Alberti, Tim Friede, Nigel Stallard, Emmanuelle Comets
The aim of phase I clinical trials is to obtain reliable information on safety, tolerability, pharmacokinetics (PK), and mechanism of action of drugs with the objective of determining the maximum tolerated dose (MTD). In most phase I studies, dose-finding and PK analysis are done separately and no attempt is made to combine them during dose allocation. In cases such as rare diseases, paediatrics, and studies in a biomarker-defined subgroup of a defined population, the available population size will limit the number of possible clinical trials that can be conducted...
March 21, 2017: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/28318688/impact-of-phenylketonuria-type-meal-on-appetite-thermic-effect-of-feeding-and-postprandial-fat-oxidation
#13
Hani Alfheeaid, Konstantinos Gerasimidis, Ana-Maria Năstase, Mie Elhauge, Barbara Cochrane, Dalia Malkova
BACKGROUND: Dietary management of phenylketonuria (PKU) requires the replacement of natural protein-containing foods with special low protein foods. The effect of a PKU type diet on factors contributing to energy balance requires investigation. OBJECTIVE: To investigate the impact of a PKU type meal on appetite ratings, gut appetite hormones, thermic effect of feeding (TEF) and fat oxidation. METHODS: Twenty-three healthy adults (mean ± SD age: 24...
March 8, 2017: Clinical Nutrition: Official Journal of the European Society of Parenteral and Enteral Nutrition
https://www.readbyqxmd.com/read/28228425/prebiotic-supplementation-improves-appetite-control-in-children-with-overweight-and-obesity-a-randomized-controlled-trial
#14
Megan P Hume, Alissa C Nicolucci, Raylene A Reimer
Background: Prebiotics have been shown to improve satiety in adults with overweight and obesity; however, studies in children are limited.Objective: We examined the effects of prebiotic supplementation on appetite control and energy intake in children with overweight and obesity.Design: This study was a randomized, double-blind, placebo-controlled trial. Forty-two boys and girls, ages 7-12 y, with a body mass index (BMI) of ≥85th percentile were randomly assigned to 8 g oligofructose-enriched inulin/d or placebo (maltodextrin) for 16 wk...
February 22, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28222742/resistant-starch-lowers-postprandial-glucose-and-leptin-in-overweight-adults-consuming-a-moderate-to-high-fat-diet-a-randomized-controlled-trial
#15
Mindy Patterson Maziarz, Sara Preisendanz, Shanil Juma, Victorine Imrhan, Chandan Prasad, Parakat Vijayagopal
BACKGROUND: High-amylose maize resistant starch type 2 (HAM-RS2) stimulates gut-derived satiety peptides and reduces adiposity in animals. Human studies have not supported these findings despite improvements in glucose homeostasis and insulin sensitivity after HAM-RS2 intake which can lower adiposity-related disease risk. The primary objective of this study was to evaluate the impact of HAM-RS2 consumption on blood glucose homeostasis in overweight, healthy adults. We also examined changes in biomarkers of satiety (glucagon-like peptide-1 [GLP-1], peptide YY [PYY], and leptin) and body composition determined by anthropometrics and dual-energy x-ray absorptiometry, dietary intake, and subjective satiety measured by a visual analogue scale following HAM-RS2 consumption...
February 21, 2017: Nutrition Journal
https://www.readbyqxmd.com/read/28222360/maintenance-therapy-with-second-generation-antipsychotics-for-bipolar-disorder-a-systematic-review-and-meta-analysis
#16
REVIEW
Leif Lindström, Eva Lindström, Mikael Nilsson, Malin Höistad
BACKGROUND: Second generations antipsychotics (SGA) are frequently used for maintenance treatment in bipolar disorder. We systematically reviewed the efficacy and long-term effects of treatment with SGA, regardless of treatment strategy (SGA administered either as monotherapy or as adjunctive therapy), in comparison to placebo, lithium or valproate. Primary outcomes were relapses (mood episode recurrence) and discontinuation. METHOD: Clinical studies were identified through database searching in PubMed, Embase, PsychInfo and Cochrane Library and critically appraised based on the Cochrane Handbook...
February 14, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/28217765/personalized-medicine-enrichment-design-for-dha-supplementation-clinical-trial
#17
Yang Lei, Matthew S Mayo, Susan E Carlson, Byron J Gajewski
Personalized medicine aims to match patient subpopulation to the most beneficial treatment. The purpose of this study is to design a prospective clinical trial in which we hope to achieve the highest level of confirmation in identifying and making treatment recommendations for subgroups, when the risk levels in the control arm can be ordered. This study was motivated by our goal to identify subgroups in a DHA (docosahexaenoic acid) supplementation trial to reduce preterm birth (gestational age<37 weeks) rate...
March 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28157671/can-wheat-germ-have-a-beneficial-effect-on-human-health-a-study-protocol-for-a-randomised-crossover-controlled-trial-to-evaluate-its-health-effects
#18
André Moreira-Rosário, Helder Pinheiro, Conceição Calhau, Luís Filipe Azevedo
INTRODUCTION: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide and diet is an important contributor to CVD risk. Thus, several food derivatives are being investigated for their beneficial impact on reducing cardiometabolic risk factors, either in risk groups or in healthy population as a preventive measure. Wheat germ is a food by-product with high nutritional value, especially as a concentrated source of dietary fibre and essential fatty acids, but its incorporation into the diet has been rare up to now...
November 10, 2016: BMJ Open
https://www.readbyqxmd.com/read/28141763/use-of-video-games-for-the-treatment-of-amblyopia
#19
REVIEW
Alexander J E Foss
PURPOSE OF REVIEW: To review the literature up to recent for the use of videos, videogames and dichoptic stimulation as a treatment for amblyopia. RECENT FINDINGS: There have been three strategies explored. The first is to use videos and videogames monocularly with the normal eye covered. The second is dichoptic stimulation with a common background presented to both eyes and an enriched foreground to the amblyopic eye. The third are games specifically designed to generate stereopsis...
May 2017: Current Opinion in Ophthalmology
https://www.readbyqxmd.com/read/28103052/adjunctive-treatment-of-psychotic-disorders-with-micronutrients
#20
Lewis Mehl-Madrona, Barbara Mainguy
OBJECTIVE: To evaluate the effect of micronutrients (minerals and vitamins) on adult psychosis when added to conventional medications by using a placebo-controlled randomized design with a 1-month open-label run-in. DESIGN: Longitudinal comparison study following a randomized, controlled trial that had failed because participants declined to undergo randomization. Setting/Locations: Rural primary care and psychiatry clinic in northern New England (town of 16,000 people)...
January 19, 2017: Journal of Alternative and Complementary Medicine: Research on Paradigm, Practice, and Policy
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