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Surrogate endpoints

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https://www.readbyqxmd.com/read/28108738/spect-and-pet-radiopharmaceuticals-for-molecular-imaging-of-apoptosis-from-bench-to-clinic
#1
Xiaobo Wang, Han Feng, Shichao Zhao, Junling Xu, Xinyu Wu, Jing Cui, Ying Zhang, Yuhua Qin, Zhiguo Liu, Tang Gao, Yongju Gao, Wenbin Zeng
Owing to the central role of apoptosis in many human diseases and the wide-spread application of apoptosis-based therapeutics, molecular imaging of apoptosis in clinical practice is of great interest for clinicians, and holds great promises. Based on the well-defined biochemical changes for apoptosis, a rich assortment of probes and approaches have been developed for molecular imaging of apoptosis with various imaging modalities. Among these imaging techniques, nuclear imaging (including single photon emission computed tomography and positron emission tomography) remains the premier clinical method owing to their high specificity and sensitivity...
January 18, 2017: Oncotarget
https://www.readbyqxmd.com/read/28107408/effect-of-positive-end-expiratory-pressure-on-the-sonographic-optic-nerve-sheath-diameter-as-a-surrogate-for-intracranial-pressure-during-robot-assisted-laparoscopic-prostatectomy-a-randomized-controlled-trial
#2
Ji-Hyun Chin, Wook-Jong Kim, Joonho Lee, Yun A Han, Jinwook Lim, Jai-Hyun Hwang, Seong-Sik Cho, Young-Kug Kim
BACKGROUND: Positive end-expiratory pressure (PEEP) can increase intracranial pressure. Pneumoperitoneum and the Trendelenburg position are associated with an increased intracranial pressure. We investigated whether PEEP ventilation could additionally influence the sonographic optic nerve sheath diameter as a surrogate for intracranial pressure during pneumoperitoneum combined with the Trendelenburg position in patients undergoing robot-assisted laparoscopic prostatectomy. METHODS: After anesthetic induction, 38 patients were randomly allocated to a low tidal volume ventilation (8 ml/kg) without PEEP group (zero end-expiratory pressure [ZEEP] group, n = 19) or low tidal volume ventilation with 8 cmH2O PEEP group (PEEP group, n = 19)...
2017: PloS One
https://www.readbyqxmd.com/read/28107394/quality-of-documentation-as-a-surrogate-marker-for-awareness-and-training-effectiveness-of-phtls-courses-part-of-the-prospective-longitudinal-mixed-methods-epptc-trial
#3
David Häske, Stefan K Beckers, Marzellus Hofmann, Rolf Lefering, Bernhard Gliwitzky, Christoph C Wölfl, Paul Grützner, Ulrich Stöckle, Marc Dieroff, Matthias Münzberg
OBJECTIVE: Care for severely injured patients requires multidisciplinary teamwork. A decrease in the number of accident victims ultimately affects the routine and skills. PHTLS ("Pre-Hospital Trauma Life Support") courses are established two-day courses for medical and non-medical rescue service personnel, aimed at improving the pre-hospital care of trauma patients worldwide. The study aims the examination of the quality of documentation before and after PHTLS courses as a surrogate endpoint of training effectiveness and awareness...
2017: PloS One
https://www.readbyqxmd.com/read/28106555/optical-coherence-tomography-reveals-retinal-neuroaxonal-thinning-in-frontotemporal-dementia-as-in-alzheimer-s-disease
#4
Laura Ferrari, Su-Chun Huang, Giuseppe Magnani, Alessandro Ambrosi, Giancarlo Comi, Letizia Leocani
BACKGROUND: Alzheimer's disease (AD) and frontotemporal dementia (FTD) are leading causes of cognitive decline. Optical coherence tomography (OCT) allows the measurement of thickness of retinal neuroaxonal layers. While in AD and mild cognitive impairment (MCI), retinal nerve fiber layer (RNFL) thinning is frequently reported, less information is available on ganglion cell layer-inner plexiform layer (GCL-IPL). Data on FTD are lacking. OBJECTIVE: To obtain cross-sectional information on RNFL and GCL-IPL thickness among MCI, AD, FTD, and healthy controls (HC), and their correlations with dementia severity...
January 18, 2017: Journal of Alzheimer's Disease: JAD
https://www.readbyqxmd.com/read/28105332/pulmonary-arterial-hypertension-associated-with-interferon-therapy-a-population-based-study
#5
Ravikanth Papani, Alexander G Duarte, Yu-Li Lin, Yong-Fang Kuo, Gulshan Sharma
BACKGROUND: Isolated cases of pulmonary arterial hypertension (PAH) with interferon α or β therapy have been reported, but no population-based estimates of the incidence of the disease after interferon exposure are available. The aim of this study was to determine the incidence of PAH after initiation of interferon therapy, using a large commercial insurance database. METHODS: Using National Drug Codes (NDCs) and Healthcare Common Procedure Coding System (HCPCS) codes, we utilized the Clinformatics™ Data Mart (CDM) database to identify subjects between 20 and 65 years old who received α or β interferon therapy between April 2001 and December 2012...
2017: Multidisciplinary Respiratory Medicine
https://www.readbyqxmd.com/read/28105158/time-dependent-transition-of-the-immunoglobulin-g-subclass-and-immunoglobulin-e-response-in-cancer-patients-vaccinated-with-cholesteryl-pullulan-melanoma-antigen-gene-a4-nanogel
#6
Noriaki Kyogoku, Hiroaki Ikeda, Takahiro Tsuchikawa, Takehiro Abiko, Aki Fujiwara, Takehiro Maki, Yoshiyuki Yamamura, Masaomi Ichinokawa, Kimitaka Tanaka, Naoko Imai, Yoshihiro Miyahara, Shinichi Kageyama, Hiroshi Shiku, Satoshi Hirano
A phase I+II clinical trial of vaccination with MAGE-A4 protein complexed with cholesteryl pullulan melanoma antigen gene-A4 nanogel (CHP-MAGE-A4) is currently underway in patients with MAGE-A4-expressing cancer. In the present study, the primary phase I endpoint was to test the safety of the administration of 300 µg CHP-MAGE-A4 with and without OK-432. Another aim of the study was to clarify the details of the specific humoral immune response to vaccination. The 9 patients enrolled for phase I were vaccinated 6 times, once every 2 weeks: 3 patients with 100 µg and 3 patients with 300 µg CHP-MAGE-A4, and 3 patients with 300 µg CHP-MAGE-A4 plus 0...
December 2016: Oncology Letters
https://www.readbyqxmd.com/read/28078103/the-potential-of-spectral-domain-optical-coherence-tomography-imaging-based-retinal-biomarkers
#7
REVIEW
Prateep Phadikar, Sandeep Saxena, Surabhi Ruia, Timothy Y Y Lai, Carsten H Meyer, Dean Eliott
BACKGROUND: Biomarker", a merged word of "biological marker", refers to a broad subcategory of medical signs that objectively indicate the state of health, and well-being of an individual. Biomarkers hold great promise for personalized medicine as information gained from diagnostic or progression markers can be used to tailor treatment to the individual for highly effective intervention in the disease process. Optical coherence tomography (OCT) has proved useful in identifying various biomarkers in ocular and systemic diseases...
2017: International Journal of Retina and Vitreous
https://www.readbyqxmd.com/read/28069654/reduced-chance-of-hearing-loss-associated-with-therapeutic-drug-monitoring-of-aminoglycosides-in-the-treatment-of-multidrug-resistant-tuberculosis
#8
R van Altena, J A Dijkstra, M E van der Meer, J F Borjas Howard, J G W Kosterink, D van Soolingen, T S van der Werf, J W C Alffenaar
Hearing loss and nephrotoxicity are associated with prolonged treatment duration and higher dosage of amikacin and kanamycin. In our Tuberculosis Center, we have employed therapeutic drug monitoring (TDM) targeting pre-set pharmacokinetic/pharmacodynamic (PK/PD) surrogate endpoints in an attempt to maintain efficacy while preventing (oto-)toxicity. To evaluate this strategy, we retrospectively evaluated medical charts of TB patients treated with amikacin or kanamycin in the period 2000 - 2012.Patients with culture-confirmed multi- or extensively drug resistant tuberculosis (MDR/XDR-TB) receiving amikacin or kanamycin as part of their TB treatment for at least 3 days were eligible for inclusion in this retrospective study...
January 9, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28066978/mrecist-to-predict-survival-in-advanced-hcc-analysis-of-two-randomised-phase-ii-trials-comparing-nintedanib-versus-sorafenib
#9
Tim Meyer, Daniel H Palmer, Ann-Lii Cheng, Julia Hocke, Arsène-Bienvenu Loembé, Chia-Jui Yen
BACKGROUND & AIMS: Response Evaluation Criteria in Solid Tumors (RECIST) has been shown to be a poor surrogate for survival benefit with targeted therapy in advanced hepatocellular carcinoma (HCC). METHODS: We investigated whether response evaluated using modified RECIST (mRECIST) predicted overall survival (OS) using data from two Phase II clinical trials. Analyses were conducted on pooled data from 188 patients with advanced HCC treated with nintedanib or sorafenib, of whom 180 were evaluable for response...
January 9, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28066627/survival-analyses-in-lung-cancer
#10
EDITORIAL
Kari Chansky, Dragan Subotic, Nathan R Foster, Torsten Blum
BACKGROUND: Although survival analyses represent one of the cornerstones in oncology in general, some aspects of the reported survival data in lung cancer patients are still not fully elucidated. METHODS: After having defined several open questions, an evidence based approach was applied in order to answer these questions. Areas of interest were: (I) possible uncertainties in reported survival data; (II) survival surrogates; (III) recommended methods for evaluating progression free survival (PFS) as a surrogate endpoint in future datasets; (IV) postoperative lung cancer recurrence and survival...
November 2016: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28065166/the-predictive-capabilities-of-a-novel-cardiovascular-magnetic-resonance-derived-marker-of-cardiopulmonary-reserve-on-established-prognostic-surrogate-markers-in-patients-with-pulmonary-vascular-disease-results-of-a-longitudinal-pilot-study
#11
Timothy J Baillie, Samuel Sidharta, Peter M Steele, Stephen G Worthley, Scott Willoughby, Karen Teo, Prashanthan Sanders, Stephen J Nicholls, Matthew I Worthley
BACKGROUND: No unified method exists to effectively predict and monitor progression of pulmonary arterial hypertension (PAH). We assessed the longitudinal relationship between a novel marker of cardiopulmonary reserve and established prognostic surrogate markers in patients with pulmonary vascular disease. METHODS AND RESULTS: Twenty participants with confirmed (n = 14) or at high risk (n = 6) for PAH underwent cardiovascular magnetic resonance (CMR) at baseline and after ~6 months of guideline-appropriate management...
January 9, 2017: Journal of Cardiovascular Magnetic Resonance
https://www.readbyqxmd.com/read/28064440/dietary-fibre-for-the-prevention-of-recurrent-colorectal-adenomas-and-carcinomas
#12
REVIEW
Yibo Yao, Tao Suo, Roland Andersson, Yongqing Cao, Chen Wang, Jingen Lu, Evelyne Chui
BACKGROUND: This is an update of the Cochrane review published in 2002.Colorectal cancer (CRC) is a major cause of morbidity and mortality in industrialised countries. Experimental evidence has supported the hypothesis that dietary fibre may protect against the development of CRC, although epidemiologic data have been inconclusive. OBJECTIVES: To assess the effect of dietary fibre on the recurrence of colorectal adenomatous polyps in people with a known history of adenomatous polyps and on the incidence of CRC compared to placebo...
January 8, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28061544/findings-from-the-adjuvant-colon-cancer-end-points-accent-collaborative-group-the-power-of-pooled-individual-patient-data-from-multiple-clinical-trials
#13
Lindsay A Renfro, Daniel J Sargent
The Adjuvant Colon Cancer End Points (ACCENT) Collaborative Group was formed 15 years ago to address scientific questions in early stage colon cancer that could best be answered by pooling individual patient data across many randomized clinical trials. Today, the ACCENT database contains detailed information collected from over 40,000 patients enrolled onto 27 major adjuvant colon cancer trials conducted between 1977 and 2009. Since its inception, the ACCENT group has led many sophisticated analyses addressing a variety of clinical questions, such as the long-term survivorship of colon cancer patients by treatment, the time course of oxaliplatin benefit, and support for the use of disease-free survival (DFS) as a surrogate endpoint for overall survival (OS), among many others...
December 2016: Chinese Clinical Oncology
https://www.readbyqxmd.com/read/28057251/proenkephalin-renal-dysfunction-and%C3%A2-prognosis-in-patients-with-acute%C3%A2-heart%C3%A2-failure-a-great-network-study
#14
Leong L Ng, Iain B Squire, Donald J L Jones, Thong Huy Cao, Daniel C S Chan, Jatinderpal K Sandhu, Paulene A Quinn, Joan E Davies, Joachim Struck, Oliver Hartmann, Andreas Bergmann, Alexandre Mebazaa, Etienne Gayat, Mattia Arrigo, Eiichi Akiyama, Zaid Sabti, Jens Lohrmann, Raphael Twerenbold, Thomas Herrmann, Carmela Schumacher, Nikola Kozhuharov, Christian Mueller
BACKGROUND: Proenkephalin A (PENK) and its receptors are widely distributed. Enkephalins are cardiodepressive and difficult to measure directly. PENK is a stable surrogate analyte of labile enkephalins that is correlated inversely with renal function. Cardiorenal syndrome is common in acute heart failure (HF) and portends poor prognosis. OBJECTIVES: This study assessed the prognostic value of PENK in acute HF, by identifying levels that may be useful in clinical decisions, and evaluated its utility for predicting cardiorenal syndrome...
January 3, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28056466/subacute-subclinical-brain-infarctions-after-transcatheter-aortic-valve-implantation-negatively-impact-cognitive-function-in-long-term-follow-up
#15
Alexander Ghanem, Jonas Dörner, Leonie Schulze-Hagen, Andreas Müller, Marius Wilsing, Jan-Malte Sinning, Julian Lütkens, Christian Frerker, Karl-Heinz Kuck, Ingo Gräff, Hans Schild, Nikos Werner, Eberhard Grube, Georg Nickenig
AIMS: To date every post-procedural cerebrovascular embolic event (CVE) is dreaded for its potential to accelerate cognitive decline after transcatheter aortic valve implantation (TAVI). This study differentiates the impact of acute (procedural) and post-acute cerebrovascular embolic events (CVEs) on cognitive performance. METHODS: Magnetic resonance imaging (MRI) before, early and late after TAVI was performed to quantify embolic burden. Quantification of diffusion- and T1-weighted lesions, as well as white-matter and total brain volumes, as well as cognitive function testing (MMSE) were assessed in 28 patients with a medium follow-up period of 34 months...
2017: PloS One
https://www.readbyqxmd.com/read/28052109/defining-surrogate-endpoints-for-clinical-trials-in-severe-falciparum-malaria
#16
Atthanee Jeeyapant, Hugh W Kingston, Katherine Plewes, Richard J Maude, Josh Hanson, M Trent Herdman, Stije J Leopold, Thatsanun Ngernseng, Prakaykaew Charunwatthana, Nguyen Hoan Phu, Aniruddha Ghose, M Mahtab Uddin Hasan, Caterina I Fanello, Md Abul Faiz, Tran Tinh Hien, Nicholas P J Day, Nicholas J White, Arjen M Dondorp
BACKGROUND: Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria. METHODS: Three datasets of clinical studies in severe malaria were re-evaluated: studies from Chittagong, Bangladesh (adults), the African 'AQUAMAT' trial comparing artesunate and quinine (children), and the Vietnamese 'AQ' study (adults) comparing artemether with quinine...
2017: PloS One
https://www.readbyqxmd.com/read/28039123/interpretation-of-surrogate-endpoints-in-the-era-of-the-21st-century-cures-act
#17
Kevin Knopf, Michael Baum, William S Shimp, Charles L Bennett, Dinah Faith, Marc L Fishman, William J M Hrushesky
No abstract text is available yet for this article.
December 30, 2016: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/28035202/nonalcoholic-steatohepatitis-and-endpoints-in-clinical-trials
#18
William N Hannah, Dawn M Torres, Stephen A Harrison
Nonalcoholic fatty liver disease (NAFLD) is now the leading cause of liver disease in developed countries, and the rates of NAFLD continue to rise in conjunction with the obesity pandemic. While the majority of patients with isolated steatosis generally have a benign course, a diagnosis of nonalcoholic steatohepatitis (NASH) carries a significantly higher risk for progression of disease, cirrhosis, and death. Pharmacologic therapeutic interventions in NASH have largely proven to be ineffective or unappealing due to long-term side-effect profiles, and the majority of patients cannot achieve or sustain targeted weight loss goals, necessitating an urgent need for therapeutic trials and drug development...
December 2016: Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28033508/pathological-complete-response-in-invasive-breast-cancer-treated-by-skin-sparing-mastectomy-and-immediate-reconstruction-following-neoadjuvant-chemotherapy-and-radiation-therapy-comparison-between-immunohistochemical-subtypes
#19
J Barrou, M Bannier, M Cohen, E Lambaudie, A Gonçalves, P Bertrand, M Buttarelli, P Opinel, N Sterkers, A Tallet, C Zinzindohoué, G Houvenaeghel
CONTEXT: Even if neoadjuvant chemotherapy (NACT) and oncoplastic techniques have increased the breast conserving surgery rate, mastectomy is still a standard for multifocal or extensive breast cancers (BC). In the prospect of increasing breast reconstruction, an alternative therapeutic protocol was developed combining NACT with neoadjuvant radiation therapy (NART), followed by mastectomy with immediate breast reconstruction (IBR). The oncological safety of this therapeutic plan still needs further exploration...
December 26, 2016: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/28032901/structure-of-proof-of-concept-studies-that-precede-a-nonalcoholic-steatohepatitis-development-program
#20
R N Williams, C Filozof, B J Goldstein, K Cusi
Surrogate endpoints for clinical proof of concept (POC) trials in nonalcoholic steatohepatitis (NASH) are based upon expert pathological review of liver biopsies. During early development, these long-term POC studies (≥48 weeks) add cost and time to the "Go/No Go" decision process. However, it is possible to conduct short-term noninvasive POC studies utilizing biomarkers and magnetic resonance imaging. Here, we discuss the use of shorter noninvasive POC studies relative to biopsy-driven studies for drug development in NASH...
November 7, 2016: Clinical Pharmacology and Therapeutics
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