keyword
MENU ▼
Read by QxMD icon Read
search

Surrogate endpoints

keyword
https://www.readbyqxmd.com/read/29053157/current-applications-of-multiparameter-flow-cytometry-in-plasma-cell-disorders
#1
REVIEW
T Jelinek, R Bezdekova, M Zatopkova, L Burgos, M Simicek, T Sevcikova, B Paiva, R Hajek
Multiparameter flow cytometry (MFC) has become standard in the management of patients with plasma cell (PC) dyscrasias, and could be considered mandatory in specific areas of routine clinical practice. It plays a significant role during the differential diagnostic work-up because of its fast and conclusive readout of PC clonality, and simultaneously provides prognostic information in most monoclonal gammopathies. Recent advances in the treatment and outcomes of multiple myeloma led to the implementation of new response criteria, including minimal residual disease (MRD) status as one of the most relevant clinical endpoints with the potential to act as surrogate for survival...
October 20, 2017: Blood Cancer Journal
https://www.readbyqxmd.com/read/29047372/effectiveness-and-safety-of-dipeptidyl-peptidase-4-inhibitors-in-the-management-of-type-2-diabetes-in-older-adults-a-systematic-review-and-development-of-recommendations-to-reduce-inappropriate-prescribing
#2
REVIEW
Gisela Schott, Yolanda V Martinez, R Erandie Ediriweera de Silva, Anna Renom-Guiteras, Anna Vögele, David Reeves, Ilkka Kunnamo, Minna Marttila-Vaara, Andreas Sönnichsen
BACKGROUND: Preventable drug-related hospital admissions can be associated with drugs used in diabetes and the benefits of strict diabetes control may not outweigh the risks, especially in older populations. The aim of this study was to look for evidence on risks and benefits of DPP-4 inhibitors in older adults and to use this evidence to develop recommendations for the electronic decision support tool of the PRIMA-eDS project. METHODS: Systematic review using a staged approach which searches for systematic reviews and meta-analyses first, then individual studies only if prior searches were inconclusive...
October 16, 2017: BMC Geriatrics
https://www.readbyqxmd.com/read/29029351/development-and-application-of-a-dual-rat-and-human-ahr-activation-assay
#3
Martin R Brown, Helen Garside, Emma Thompson, Saseela Atwal, Chloe Bean, Tony Goodall, Michael Sullivan, Mark J Graham
Significant prolonged AHR activation, classically exhibited following exposure to TCDD (dioxin), can cause a variety of undesirable toxicological effects. Novel pharmaceutical chemistries also have the potential to cause activation of AHR and consequent toxicities in pre-clinical species and man. Previous methods either employed relatively expensive and low throughput primary hepatocyte dosing with PCR endpoint, or low resolution overexpressing reporter gene assays. We have developed, validated and applied an in vitro microtitre plate imaging-based medium throughput screening assay for the assessment of endogenous species-specific AHR activation potential via detection of induction of the surrogate transcriptional target Cytochrome P450 CYP1A1...
September 18, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/29020983/cxcr2-inhibition-a-novel-approach-to-treating-coronary-heart-disease-cicada-study-protocol-for-a-randomised-controlled-trial
#4
Jubin P Joseph, Eliana Reyes, Josephine Guzman, Jim O'Doherty, Hannah McConkey, Satpal Arri, Rahul Kakkar, Nicholas Beckley, Abdel Douiri, Sally F Barrington, Simon R Redwood, Albert Ferro
BACKGROUND: There is emerging evidence of the central role of neutrophils in both atherosclerotic plaque formation and rupture. Patients with lower neutrophil counts following acute coronary syndromes tend to have a greater coronary flow reserve, which is a strong predictor of long-term cardiovascular health. But so far, no data are available regarding the impact of neutrophil inhibition on cardiovascular clinical or surrogate endpoints. Therefore, the aim of this study is to investigate the effects of AZD5069, a cysteine-X-cysteine chemokine receptor 2 (CXCR2) inhibitor, on coronary flow reserve and coronary structure and function in patients with coronary artery disease...
October 11, 2017: Trials
https://www.readbyqxmd.com/read/29020339/can-viral-load-be-used-as-a-surrogate-marker-in-clinical-studies-of-cytomegalovirus-in-solid-organ-transplantation-a-systematic-review-and-meta-analysis
#5
Yoichiro Natori, Ali Alghamdi, Mahmood Tazari, Veronica Miller, Shahid Husain, Takashi Komatsu, Paul Griffiths, Per Ljungman, Ani Orchanian-Cheff, Deepali Kumar, Atul Humar
Symptomatic CMV disease has been the standard endpoint for clinical trials in organ transplant recipients. Viral load may be a more relevant endpoint due to low frequency of disease. We performed a meta-analysis and systematic review of the literature. We found several lines of evidence to support the validity of viral load as an appropriate surrogate end-point including 1)viral loads in CMV disease are significantly greater than in asymptomatic viremia (OR 9.3, 95%CI 4.6 to 19.3); 2)kinetics of viral replication are strongly associated with progression to disease; 3)pooled incidence of CMV viremia and disease is significantly lower during prophylaxis compared with the full patient followup period (viremia incidence: 3...
September 5, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29019452/minimal-residual-disease-analysis-in-myeloma-when-why-and-where
#6
Uday Yanamandra, Shaji K Kumar
The primary hurdle in the path to curing multiple myeloma (MM) is defining a validated minimal residual disease (MRD) and its utility in the therapeutic decision making. A better definition of MRD will aid in tailoring MM therapy further to address the clonal heterogeneity and genomic instability and overcome patient's ineffective immune surveillance. MRD analysis can define the logical endpoint for maintenance therapy, in addition also aids in providing a better clinical end point for studies comparing novel agents in myeloma...
October 11, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28994348/from-pathogenesis-to-novel-therapies-in-the-treatment-of-primary-biliary-cholangitis
#7
Vincenzo Ronca, Marco Carbone, Francesca Bernuzzi, Federica Malinverno, Hani S Mousa, M Eric Gershwin, Pietro Invernizzi
Primary biliary cholangitis (PBC) is an immune-mediated liver disease characterized by chronic inflammation of the intrahepatic bile ducts, causing progressive ductopenia, cholestasis and fibrosis, and leading to liver failure. Ursodeoxycholic acid (UDCA) is the first-line therapy for the treatment of PBC patients. This is effective in majority of patients; however, up to 20 percent of patients have an incomplete response to UDCA therapy and have a reduced prognosis as compared to healthy individuals. Obeticholic acid (OCA) has been recently registered as second-line therapy for patients with incomplete response to UDCA, with plans to demonstrate the long-term clinical efficacy...
October 10, 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28990216/left-atrial-volume-changes-is-an-early-marker-of-end-organ-damage-in-essential-hypertension-a-multidisciplinary-approach-to-an-old-problem
#8
Batur Kanar, Beste Ozben, Hatice Selen Kanar, Aysu Arsan, Kursat Tigen
PURPOSE: Left atrial (LA) volume has been shown to be a predictor of adverse cardiovascular outcomes. The aim of this study was to evaluate the relation between LA phasic volumes and hypertensive end-organ damage (EOD), by using real time three-dimensional echocardiography (RT3DE) in patients with essential hypertension (HT). METHODS: The study included 95 essential hypertensive patients (60 ± 10 years, 37 males). The patients were divided into three according to the presence of EOD, namely microalbuminuria and retinal vascular changes detected by direct ophthalmoscopy...
October 9, 2017: Echocardiography
https://www.readbyqxmd.com/read/28973375/comparative-dose-response-analysis-of-liver-and-kidney-transcriptomic-effects-of-trichloroethylene-and-tetrachloroethylene-in-b6c3f1-mouse
#9
Yi-Hui Zhou, Joseph A Cichocki, Valerie Y Soldatow, Elizabeth Scholl, Paul Gallins, Dereje Jima, Hong-Sik Yoo, Weihsueh A Chiu, Fred A Wright, Ivan Rusyn
Trichloroethylene (TCE) and tetrachloroethylene (PCE) are ubiquitous environmental contaminants and occupational health hazards. Recent health assessments of these agents identified several critical data gaps, including lack of comparative analysis of their effects. This study examined liver and kidney effects of TCE and PCE in a dose-response study design. Equimolar doses of TCE (24, 80, 240, 800 mg/kg) or PCE (30, 100, 300, 1,000 mg/kg) were administered by gavage in aqueous vehicle to male B6C3F1/J mice...
August 16, 2017: Toxicological Sciences: An Official Journal of the Society of Toxicology
https://www.readbyqxmd.com/read/28970189/impact-of-a-telehealth-program-with-voice-recognition-technology-in-patients-with-chronic-heart-failure-feasibility-study
#10
Heesun Lee, Jun-Bean Park, Sae Won Choi, Yeonyee E Yoon, Hyo Eun Park, Sang Eun Lee, Seung-Pyo Lee, Hyung-Kwan Kim, Hyun-Jai Cho, Su-Yeon Choi, Hae-Young Lee, Jonghyuk Choi, Young-Joon Lee, Yong-Jin Kim, Goo-Yeong Cho, Jinwook Choi, Dae-Won Sohn
BACKGROUND: Despite the advances in the diagnosis and treatment of heart failure (HF), the current hospital-oriented framework for HF management does not appear to be sufficient to maintain the stability of HF patients in the long term. The importance of self-care management is increasingly being emphasized as a promising long-term treatment strategy for patients with chronic HF. OBJECTIVE: The objective of this study was to evaluate whether a new information communication technology (ICT)-based telehealth program with voice recognition technology could improve clinical or laboratory outcomes in HF patients...
October 2, 2017: JMIR MHealth and UHealth
https://www.readbyqxmd.com/read/28966105/oligonucleotide-based-pharmaceuticals-non-clinical-and-clinical-safety-signals-and-non-clinical-testing-strategies
#11
Enni-Kaisa Mustonen, Tiina Palomäki, Markku Pasanen
Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view...
September 29, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/28948706/the-effect-of-intracoronary-infusion-of-bone-marrow-derived-mononuclear-cells-on-all-cause-mortality-in-acute-myocardial-infarction-rationale-and-design-of-the-bami-trial
#12
Anthony Mathur, Roman Arnold, Birgit Assmus, Jozef Bartunek, Ann Belmans, Halvard Bönig, Filippo Crea, Stefanie Dimmeler, Sheik Dowlut, Francisco Fernández-Avilés, Manuel Galiñanes, David Garcia-Dorado, Juha Hartikainen, Jonathan Hill, Annette Hogardt-Noll, Christian Homsy, Stefan Janssens, Petr Kala, Jens Kastrup, John Martin, Philippe Menasche, Roman Miklik, Abdul Mozid, J Alberto San Román, Ricardo Sanz-Ruiz, Michal Tendera, Wojtek Wojakowski, Seppo Ylä-Herttuala, Andreas Zeiher
Over the past 13 years bone marrow-derived mononuclear cells (BM-MNCs) have been widely investigated for clinical efficacy in patients following acute myocardial infarction (AMI). These early phase II trials have used various surrogate markers to judge efficacy and, although promising, the results have been inconsistent. The phase III BAMI trial has therefore been designed to demonstrate that intracoronary infusion of BM-MNCs is safe and will significantly reduce the time to first occurrence of all-cause death in patients with reduced left ventricular ejection fraction after successful reperfusion for ST-elevation AMI (powered with the aim of detecting a 25% reduction in all-cause mortality)...
September 25, 2017: European Journal of Heart Failure
https://www.readbyqxmd.com/read/28929484/post-marketing-research-and-its-outcome-for-novel-anticancer-agents-approved-by-both-the-fda-and-ema-between-2005-and-2010-a-cross-sectional-study
#13
Jean-David Zeitoun, Gabriel Baron, Alexandre Vivot, Ignacio Atal, Nicholas S Downing, Joseph S Ross, Philippe Ravaud
Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment...
September 20, 2017: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/28921820/systematic-review-and-network-meta-analysis-on-the-relative-efficacy-of-osteoporotic-medications-men-with-prostate-cancer-on-continuous-androgen-deprivation-therapy%C3%A2-to-reduce-risk-of-fragility-fractures
#14
REVIEW
Yeesha Poon, Petros Pechlivanoglou, Shabbir M H Alibhai, David Naimark, Jeffrey S Hoch, Emmanuel Papadimitropoulos, Mary-Ellen Hogan, Murray Krahn
BACKGROUND: Androgen deprivation therapy (ADT) is an effective treatment for men with advanced prostate cancer, but loss of bone mineral density (BMD) is a major risk factor for fractures. This analysis evaluated the relative effectiveness of osteoporosis treatments using BMD as a surrogate endpoint for fragility fractures in men on continuous ADT. METHOD: We included randomized controlled trials studying bisphosphonates, denosumab, toremifene, and raloxifene in patients with non-metastatic prostate cancer on ADT for review...
September 18, 2017: BJU International
https://www.readbyqxmd.com/read/28916466/a-multi-centered-epidemiological-study-evaluating-the-validity-of-the-treatment-difficulty-indices-developed-by-the-japan-prosthodontic-society
#15
Takuo Kuboki, Tetsuo Ichikawa, Kazuyoshi Baba, Masanori Fujisawa, Hironobu Sato, Hideki Aita, Shigeto Koyama, Masayuki Hideshima, Yuji Sato, Hiroyuki Wake, Aya Kimura-Ono, Kan Nagao, Yorika Kodaira-Ueda, Katsushi Tamaki, Shinsuke Sadamori, Kazuhiro Tsuga, Yasuhiro Nishi, Takashi Sawase, Hisashi Koshino, Shin-Ichi Masumi, Kaoru Sakurai, Kanji Ishibashi, Takashi Ohyama, Yasumasa Akagawa, Toshihiro Hirai, Keiichi Sasaki, Kiyoshi Koyano, Hirofumi Yatani, Hideo Matsumura
PURPOSE: The Japan Prosthodontic Society developed a multi-axis assessment protocol to evaluate the complex variations in patients who need prosthodontic care, and to classify the level of treatment difficulty. A previous report found the protocol to be sufficiently reliable. The purpose of this multi-center cohort study was to evaluate the validity of this multi-axis assessment protocol. METHODS: The treatment difficulty was evaluated using the multi-axis assessment protocol before starting prosthodontic treatment...
September 12, 2017: Journal of Prosthodontic Research
https://www.readbyqxmd.com/read/28903444/early-tumour-shrinkage-as-a-survival-predictor-in-patients-with-recurrent-glioblastoma-treated-with-bevacizumab-in-the-avareg-randomized-phase-ii-study
#16
Alba A Brandes, Gaetano Finocchiaro, Vittorina Zagonel, Michele Reni, Alessandra Fabi, Claudia Caserta, Alicia Tosoni, Marica Eoli, Giuseppe Lombardi, Matteo Clavarezza, Alexandro Paccapelo, Stefania Bartolini, Luigi Cirillo, Raffaele Agati, Enrico Franceschi
BACKGROUND: Disease assessment for recurrent glioblastoma (GBM) represents a challenge, especially with the use of antiangiogenic agents. Moreover, validated neuroradiological predictors of outcome are lacking. Recently, the concept of early tumor shrinkage (ETS) has been developed to better assess the ability of treatments in determining a rapid and remarkable tumor response. The aim of the study was to evaluate the role of ETS in predicting survival of GBM patients treated with BEV...
August 15, 2017: Oncotarget
https://www.readbyqxmd.com/read/28889347/decline-in-estimated-glomerular-filtration-rate-is-associated-with-risk-of-end-stage-renal-disease-in-type-2-diabetes-with-macroalbuminuria-an-observational-study-from-jdncs
#17
Miho Shimizu, Kengo Furuichi, Tadashi Toyama, Tomoaki Funamoto, Shinji Kitajima, Akinori Hara, Daisuke Ogawa, Daisuke Koya, Kenzo Ikeda, Yoshitaka Koshino, Yukie Kurokawa, Hideharu Abe, Kiyoshi Mori, Masaaki Nakayama, Yoshio Konishi, Ken-Ichi Samejima, Masaru Matsui, Hiroyuki Yamauchi, Tomohito Gohda, Kei Fukami, Daisuke Nagata, Hidenori Yamazaki, Yukio Yuzawa, Yoshiki Suzuki, Shouichi Fujimoto, Shoichi Maruyama, Sawako Kato, Takero Naito, Kenichi Yoshimura, Hitoshi Yokoyama, Takashi Wada
BACKGROUND: There is increased interest in surrogate endpoints for clinical trials of chronic kidney disease. METHODS: In this nationwide observational study of 456 patients with type 2 diabetes and clinically suspected diabetic nephropathy followed for a median of 4.2 years, we evaluated the association between estimated glomerular filtration rate (eGFR) and albuminuria at baseline or during follow-up and risk of ESRD. RESULTS: Low eGFR (<60 mL/min/1...
September 9, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28888522/sleep-disordered-breathing-and-heart%C3%A2-failure-what-does-the-future-hold
#18
REVIEW
Martin R Cowie, Angela M Gallagher
Most patients with heart failure (HF) have sleep-disordered breathing (SDB), with central (rather than obstructive) sleep apnea becoming the predominant form in patients with more severe disease. Cyclical apnea and hypopneas are associated with sleep disturbance, hypoxemia, hemodynamic changes, and sympathetic activation. These patients have a worse prognosis than those without SDB. Mask-based therapies of positive airway pressure targeted at SDB can improve measures of sleep quality and can partially normalize the sleep and respiratory physiology...
October 2017: JACC. Heart Failure
https://www.readbyqxmd.com/read/28884361/importance-of-glomerular-filtration-rate-change-as-surrogate-endpoint-for-the-future-incidence-of-end-stage-renal-disease-in-general-japanese-population-community-based-cohort-study
#19
Eiichiro Kanda, Tomoko Usui, Naoki Kashihara, Chiho Iseki, Kunitoshi Iseki, Masaomi Nangaku
BACKGROUND: Because of the necessity for extended period and large costs until the event occurs, surrogate endpoints are indispensable for implementation of clinical studies to improve chronic kidney disease (CKD) patients' prognosis. METHODS: Subjects with serum creatinine level for a baseline period over 1-3 years were enrolled (n = 69,238) in this community-based prospective cohort study in Okinawa, Japan, and followed up for 15 years. The endpoint was end-stage renal disease (ESRD)...
September 7, 2017: Clinical and Experimental Nephrology
https://www.readbyqxmd.com/read/28881354/preoperative-capecitabine-oxaliplatin-and-irinotecan-in-resectable-gastric-or-gastroesophageal-junction-cancer-pathological-response-as-primary-endpoint-and-fdg-pet-predictions
#20
Rosa Berenato, Federica Morano, Filippo Pietrantonio, Christian Cotsoglou, Marta Caporale, Gabriele Infante, Alessandro Pellegrinelli, Alessandra Alessi, Carlo Battiston, Jorgelina Coppa, Barbara Padovano, Alessia Mennitto, Monica Niger, Giovanni Fucà, Silvia Lazzati, Giorgio Greco, Gabriele Delconte, Filippo de Braud, Vincenzo Mazzaferro, Maria Di Bartolomeo
OBJECTIVES: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. METHODS: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al...
September 8, 2017: Oncology
keyword
keyword
14869
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"