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Enriched trial design

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https://www.readbyqxmd.com/read/28681133/innovative-clinical-trial-designs-for-precision-medicine-in-heart-failure-with-preserved-ejection-fraction
#1
Sanjiv J Shah
A major challenge in the care of patients with heart failure and preserved ejection fraction (HFpEF) is the lack of proven therapies due to disappointing results from randomized controlled trials (RCTs). The heterogeneity of the HFpEF syndrome and the use of conventional RCT designs are possible reasons underlying the failure of these trials. There are several factors-including the widespread adoption of electronic health records, decreasing costs of obtaining high-dimensional data, and the availability of a wide variety of potential therapeutics-that have evolved to enable more innovative clinical trial designs in HFpEF...
June 2017: Journal of Cardiovascular Translational Research
https://www.readbyqxmd.com/read/28673539/trial-designs-and-results-supporting-treatment-de-escalation-and-escalation
#2
Meredith M Regan, William T Barry
Trials for escalation and de-escalation of treatment aim to improve patient care, but from different sides of the same coin with respect to disease control and burdens of treatment. De-escalation of therapy is inherently a non-inferiority question. A design with random assignment to standard of care versus de-escalated therapy is typically implemented but ordinarily will require a large sample size. Some research questions of treatment de-escalation might be asked in select patient populations using single-arm designs...
June 30, 2017: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28664851/clinical-trials-in-acute-respiratory-distress-syndrome-challenges-and-opportunities
#3
REVIEW
Michael A Matthay, Daniel F McAuley, Lorraine B Ware
This year is the 50th anniversary of the first description of acute respiratory distress syndrome (ARDS). Since then, much has been learned about the pathogenesis of lung injury in ARDS, with an emphasis on the mechanisms of injury to the lung endothelium and the alveolar epithelium. In terms of treatment, major progress has been made in reducing mortality from ARDS with lung-protective ventilation, using a tidal volume of 6 mL per kg of predicted bodyweight and a plateau airway pressure of less than 30 cm H2O...
June 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28637773/follow-up-of-a-randomized-trial-on-postdischarge-nutrition-in-preterm-born-children-at-age-8-y
#4
Charlotte A Ruys, Monique van de Lagemaat, Martijn Jj Finken, Harrie N Lafeber
Background: Early nutritional interventions may modulate health risks in preterm-born infants. Previously, we showed that preterm-born infants fed an isocaloric protein- and mineral-enriched postdischarge formula (PDF) from term age to 6-mo corrected age (CA) gained more lean mass than did those fed term formula (TF). Long-term follow-up of randomized nutritional trials is important to test the hypothesis that short-term positive effects on health are sustainable.Objective: The aim of this follow-up study was to compare body size, body composition, and metabolic health at age 8 y in preterm-born children who were randomly assigned to receive either PDF or TF from term age until 6-mo CA...
June 21, 2017: American Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28636752/comparison-of-effect-sizes-between-enriched-and-non-enriched-trials-of-analgesics-for-chronic-musculoskeletal-pain-a-systematic-review
#5
Tie P Yamato, Chris G Maher, Bruno T Saragiotto, Christina Abdel Shaheed, Anne M Moseley, Chung-Wei Christine Lin, Bart Koes, Andrew J McLachlan
OBJECTIVE: To investigate the use of an enriched study design on the estimates of treatment effect in analgesic trials for chronic musculoskeletal pain METHODS: Database searches were conducted from 2004 to 2014. We included randomised placebo-controlled trials evaluating pain medications for chronic musculoskeletal pain. Methodological quality was assessed using the PEDro scale. The estimates of treatment effect on pain and adverse events were compared between enriched and non-enriched designs...
June 21, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28636403/applying-precision-medicine-to-trial-design-using-physiology-extracorporeal-co2-removal-for-ards
#6
Ewan C Goligher, Marcelo B P Amato, Arthur S Slutsky
In clinical trials of therapies for ARDS, the average treatment effect in the study population may be attenuated because individual patient responses vary widely. This inflates sample size requirements and increases the cost and difficulty of conducting successful clinical trials. One solution is to enrich the study population with patients most likely to benefit based on predicted patient response to treatment (predictive enrichment). In this perspective, we apply the precision medicine paradigm to the emerging use of extracorporeal CO2 removal (ECCO2R) for ultra-protective ventilation in ARDS...
June 21, 2017: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/28631582/effect-of-green-tea-extract-supplementation-on-glycogen-replenishment-in-exercised-human-skeletal-muscle
#7
Tsen-Wei Tsai, Chia-Chen Chang, Su-Fen Liao, Yi-Hung Liao, Chien-Wen Hou, Jung-Piao Tsao, I-Shiung Cheng
The purpose of this study was to investigate the effects of 8-week green tea extract (GTE) supplementation on promoting postexercise muscle glycogen resynthesis and systemic energy substrate utilisation in young college students. A total of eight healthy male participants (age: 22·0 (se 1·0) years, BMI: 24·2 (se 0·7) kg/m2, VO2max: 43·2 (se 2·4) ml/kg per min) participated in this study. GTE (500 mg/d for 8 weeks) was compared with placebo in participants in a double-blind/placebo-controlled and crossover study design with an 8-week washout period...
May 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/28626811/the-enrich-study-to-evaluate-the-effectiveness-of-a-combination-intervention-package-to-improve-isoniazid-preventive-therapy-initiation-adherence-and-completion-among-people-living-with-hiv-in-ethiopia-rationale-and-design-of-a-mixed-methods-cluster-randomized
#8
Andrea A Howard, Yael Hirsch-Moverman, Suzue Saito, Tsigereda Gadisa, Amrita Daftary, Zenebe Melaku
BACKGROUND: Isoniazid preventive therapy (IPT) prevents tuberculosis among HIV-positive individuals, however implementation is suboptimal. Implementation science studies are needed to identify interventions to address this evidence-to-program gap. OBJECTIVE: The ENRICH Study is a mixed methods cluster randomized trial aimed at evaluating the effectiveness and acceptability of a combination intervention package (CIP) to improve IPT implementation in Ethiopia. DESIGN: Ten health centers were randomized to receive the CIP or standard of care...
June 2017: Contemporary Clinical Trials Communications
https://www.readbyqxmd.com/read/28593470/effect-of-selenium-from-selenium-enriched-kale-sprout-versus-other-selenium-sources-on-productivity-and-selenium-concentrations-in-egg-and-tissue-of-laying-hens
#9
Anut Chantiratikul, Orawan Chinrasri, Piyanete Chantiratikul
A 6-week trial was conducted to compare the effect of selenium (Se) from hydroponically produced Se-enriched kale sprout (HPSeKS), sodium selenite (SS), and Se-enriched yeast (SeY) in laying hens. A total of 144 40-week-old hens were randomly divided into four groups, according to a completely randomized design. Each group consisted of four replicates with nine hens per replicate. The dietary treatments were T1 (basal diet) and T2, T3, and T4 (basal diets supplemented with 0.30 mg Se/kg from SS, SeY, and HPSeKS, respectively)...
June 7, 2017: Biological Trace Element Research
https://www.readbyqxmd.com/read/28581200/natural-history-of-second-biochemical-failure-following-salvage-radiation-therapy-for-prostate-cancer-a-multi-institution-study
#10
Vasu Tumati, William C Jackson, Ahmed E Abugharib, Ganesh Raj, Claus Roehrborn, Yair Lotan, Kevin Courtney, Aditya Bagrodia, Jeffrey C Gahan, Zachary S Zumsteg, Michael R Folkert, Aaron M Laine, Raquibul Hannan, Daniel E Spratt, Neil B Desai
OBJECTIVES: To describe the natural history of prostate cancer in men who experience a second biochemical recurrence (BCR) after salvage radiotherapy (SRT) following prostatectomy. SUBJECTS/PATIENTS AND METHODS: Following SRT at two institutions from 1986-2013, 286 patients developed second BCR, defined as two rises in PSA of ≥0.2 ng/mL above nadir. Event rates for distant metastasis (DM) or freedom from DM (FFDM), castration-resistant prostate cancer (CRPC), prostate cancer-specific survival (PCSS), and overall survival (OS) were estimated using the Kaplan-Meier method...
June 5, 2017: BJU International
https://www.readbyqxmd.com/read/28570268/network-analysis-of-the-genomic-basis-of-the-placebo-effect
#11
Rui-Sheng Wang, Kathryn T Hall, Franco Giulianini, Dani Passow, Ted J Kaptchuk, Joseph Loscalzo
The placebo effect is a phenomenon in which patients who are given an inactive treatment (e.g., inert pill) show a perceived or actual improvement in a medical condition. Placebo effects in clinical trials have been investigated for many years especially because placebo treatments often serve as the control arm of randomized clinical trial designs. Recent observations suggest that placebo effects may be modified by genetics. This observation has given rise to the term "placebome," which refers to a group of genome-related mediators that affect an individual's response to placebo treatments...
June 2, 2017: JCI Insight
https://www.readbyqxmd.com/read/28569123/diffusion-weighted-imaging-or-computerized-tomography-perfusion-assessment-with-clinical-mismatch-in-the-triage-of-wake-up-and-late-presenting-strokes-undergoing-neurointervention-with-trevo-dawn-trial-methods
#12
Tudor G Jovin, Jeffrey L Saver, Marc Ribo, Vitor Pereira, Anthony Furlan, Alain Bonafe, Blaise Baxter, Rishi Gupta, Demetrius Lopes, Olav Jansen, Wade Smith, Daryl Gress, Steven Hetts, Roger J Lewis, Ryan Shields, Scott M Berry, Todd L Graves, Tim Malisch, Ansaar Rai, Kevin N Sheth, David S Liebeskind, Raul G Nogueira
Rationale Efficacy of mechanical thrombectomy for acute stroke due to large vessel occlusion initiated beyond 6 h of time last seen well has not been demonstrated in randomized trials. Aim To establish whether subjects considered to have substantial areas of salvageable brain based on age-adjusted clinical core mismatch who can undergo endovascular treatment within 6-24 h from time last seen well (TLSW) have better outcomes at three months compared to subjects treated with standard medical therapy alone...
January 1, 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28536178/topical-review-adaptive-enrichment-designs-for-stroke-clinical-trials
#13
REVIEW
Michael Rosenblum, Daniel F Hanley
No abstract text is available yet for this article.
May 23, 2017: Stroke; a Journal of Cerebral Circulation
https://www.readbyqxmd.com/read/28535777/plasma-phospholipid-fatty-acid-profile-confirms-compliance-to-a-novel-saturated-fat-reduced-monounsaturated-fat-enriched-dairy-product-intervention-in-adults-at-moderate-cardiovascular-risk-a-randomized-controlled-trial
#14
Oonagh Markey, Dafni Vasilopoulou, Kirsty E Kliem, Albert Koulman, Colette C Fagan, Keith Summerhill, Laura Y Wang, Alistair S Grandison, David J Humphries, Susan Todd, Kim G Jackson, David I Givens, Julie A Lovegrove
BACKGROUND: Dairy products are a major contributor to dietary SFA. Partial replacement of milk SFA with unsaturated fatty acids (FAs) is possible through oleic-acid rich supplementation of the dairy cow diet. To assess adherence to the intervention of SFA-reduced, MUFA-enriched dairy product consumption in the RESET (REplacement of SaturatEd fat in dairy on Total cholesterol) study using 4-d weighed dietary records, in addition to plasma phospholipid FA (PL-FA) status. METHODS: In a randomised, controlled, crossover design, free-living UK participants identified as moderate risk for CVD (n = 54) were required to replace habitually consumed dairy foods (milk, cheese and butter), with study products with a FA profile typical of retail products (control) or SFA-reduced, MUFA-enriched profile (modified), for two 12-week periods, separated by an 8-week washout period...
May 23, 2017: Nutrition Journal
https://www.readbyqxmd.com/read/28533227/detecting-the-presence-and-progression-of-premalignant-lung-lesions-via-airway-gene-expression
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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