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Enriched trial design

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https://www.readbyqxmd.com/read/28533227/detecting-the-presence-and-progression-of-premalignant-lung-lesions-via-airway-gene-expression
#1
Jennifer Beane, Sarah A Mazzilli, Anna M Tassinari, Gang Liu, Xiaohui Zhang, Hanqiao Liu, Anne Dy Buncio, Samjot S Dhillon, Suso J Platero, Marc E Lenburg, Mary E Reid, Stephen Lam, Avrum E Spira
  Lung cancer (LC) is the leading cause of cancer death in the US. The molecular events preceding the onset of disease are poorly understood and no effective tools exist to identify smokers with premalignant lesions (PMLs) that will progress to invasive cancer. Prior work identified molecular alterations in the smoke-exposed airway field of injury associated with LC.  Here we focus on an earlier stage in the disease process leveraging the airway field of injury to study PMLs and its utility in LC chemoprevention...
May 22, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28523293/-triple-positive-breast-cancer-a-novel-category
#2
George Iancu, DănuŢ Vasile, Raluca Claudia Iancu, Dragoş Virgil DaviŢoiu
Breast cancer (BC) biology is of outmost importance for its therapeutic management and for establishing patients' outcome. Breast cancer has been divided in subtypes depending on the presence of hormone receptors (HRs) for estrogen and progesterone and human epidermal growth factor receptor 2 (HER2) gene amplification. Recently, a distinct subcategory has been analyzed from the group of HER2-enriched BC with positive HR, namely HER2 positive with high levels of hormone receptor expression, suggestively named "triple positive" breast cancer...
2017: Romanian Journal of Morphology and Embryology, Revue Roumaine de Morphologie et Embryologie
https://www.readbyqxmd.com/read/28523255/the-effect-of-husbands-education-regarding-menopausal-health-on-marital-satisfaction-of-their-wives
#3
Nooshin Yoshany, Mohammad Ali Morowatisharifabad, Hamideh Mihanpour, Narjes Bahri, Khair Mohammad Jadgal
OBJECTIVES: Marital satisfaction has an important effect on people's mental health. Due to the increasing average age and life expectancy of Iranian women, obtaining knowledge about sexual aspects of post-menopause women for partners can improve their health and quality of life. This study aimed to determine the effect of education for the husbands regarding menopause on marital satisfaction of their wives. METHODS: This randomized controlled trial was conducted on 100 women aged 45 to 55 years old and their husbands in Yazd in 2014...
April 2017: Journal of Menopausal Medicine
https://www.readbyqxmd.com/read/28520893/using-bayesian-modeling-in-frequentist-adaptive-enrichment-designs
#4
Noah Simon, Richard Simon
Our increased understanding of the mechanistic heterogeneity of diseases has pushed the development of targeted therapeutics. We do not expect all patients with a given disease to benefit from a targeted drug; only those in the target population. That is, those with sufficient dysregulation in the biomolecular pathway targeted by treatment. However, due to complexity of the pathway, and/or technical issues with our characterizing assay, it is often hard to characterize the target population until well into large-scale clinical trials...
May 17, 2017: Biostatistics
https://www.readbyqxmd.com/read/28488685/effect-of-diets-rich-in-either-saturated-fat-or-n-6-polyunsaturated-fatty-acids-and-supplemented-with-long-chain-n-3-polyunsaturated-fatty-acids-on-plasma-lipoprotein-profiles
#5
C B Dias, N Amigo, L G Wood, X Correig, M L Garg
BACKGROUND/OBJECTIVES: Abnormalities in lipoprotein profiles (size, distribution and concentration) play an important role in the pathobiology of atherosclerosis and coronary artery disease. Dietary fat, among other factors, has been demonstrated to modulate lipoprotein profiles. We aimed to investigate if background dietary fat (saturated, SFA versus omega-6 polyunsaturated fatty acids, n-6PUFA) was a determinant of the effects of LCn-3PUFA supplementation on lipoprotein profiles. SUBJECTS/METHODS: A randomized controlled clinical intervention trial in a parallel design was conducted...
May 10, 2017: European Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28453704/genomic-characterization-of-her2-positive-breast-cancer-and-response-to-neoadjuvant-trastuzumab-and-chemotherapy-results-from-the-acosog-z1041-alliance-trial
#6
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. Patients and methods: In supplement to tissues from 37 Z1041 cases, 11 similarly treated cases were obtained from a single institution study (NCT00353483)...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28435450/exome-sequencing-of-oral-squamous-cell-carcinoma-reveals-molecular-subgroups-and-novel-therapeutic-opportunities
#7
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
#8
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
#9
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
#10
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
#11
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)...
June 1, 2017: Physiology & Behavior
https://www.readbyqxmd.com/read/28374784/targeting-c-met-in-gastrointestinal-tumours-rationale-opportunities-and-challenges
#12
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
#13
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
#14
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
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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