Relevant bibliographies by topics / Secondary endpoint

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers

Academic literature on the topic 'Secondary endpoint'

Author: Grafiati
Published: 4 June 2021
Last updated: 11 February 2022

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Journal articles on the topic "Secondary endpoint"

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Santosh Kumar, Rada, and A. Rama Krishna. "Clinical Endpoint: Substitute for Prediction of Clinical Benefit." Journal of Drug Delivery and Therapeutics 9, no. 4-s (August 29, 2019): 800–802. http://dx.doi.org/10.22270/jddt.v9i4-s.3367.

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An endpoint is a primary or secondary outcome used to judge the effectiveness of a treatment; it is a precisely defined variable intended to reflect an outcome of interest thatis statistically analyzed. An endpoint usually specifies the sort of assessments made, the timing of those assessments, the assessment tools used and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. There are different types of endpoints used in clinical trails like primary endpoint, secondary endpoint, multiple endpoint and surrogate endpoint. Primary endpoint means the outcome or event that most accurately measures the benefit of the therapy or drug being studied and this is the most clinically important endpoint. Secondary endpoints are related to toxicity and undesired effects of the new therapy to demonstrate additional effects on the disease or condition. Multiple endpoint is useful in determining clinical advantage of drug depending on one illness side. A surrogate endpoint is a laboratory measure or a physical sign supposed to be used as a substitute for a clinically meaningful endpoint which in all fairness possible to predict clinical benefit.
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Maestrini, Ilaria, Marta Altieri, Laura Di Clemente, Edoardo Vicenzini, Patrizia Pantano, Eytan Raz, Mauro Silvestrini, et al. "Longitudinal Study on Low-Dose Aspirin versus Placebo Administration in Silent Brain Infarcts: The Silence Study." Stroke Research and Treatment 2018 (October 3, 2018): 1–9. http://dx.doi.org/10.1155/2018/7532403.

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Background. We investigated low-dose aspirin (ASA) efficacy and safety in subjects with silent brain infarcts (SBIs) in preventing new cerebrovascular (CVD) events as well as cognitive impairment.Methods. We included subjects aged ≥45 years, with at least one SBI and no previous CVD. Subjects were followed up to 4 years assessing CVD and SBI incidence as primary endpoint and as secondary endpoints: (a) cardiovascular and adverse events and (b) cognitive impairment.Results. Thirty-six subjects received ASA while 47 were untreated. Primary endpoint occurred in 9 controls (19.1%) versus 2 (5.6%) in the ASA group (p=0.10). Secondary endpoints did not differ in the two groups. Only baseline leukoaraiosis predicts primary [OR 5.4 (95%CI 1.3-22.9, p=0.022)] and secondary endpoint-a [3.2 (95%CI 1.1-9.6, p=0.040)] occurrence.Conclusions. These data show an increase of new CVD events in the untreated group. Despite the study limitations, SBI seems to be a negative prognostic factor and ASA preventive treatment might improve SBI prognosis.EU Clinical trialis registered with EudraCT Number:2005-000996-16; Sponsor Protocol Number: 694/30.06.04.
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O'Neill, Robert T. "Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance." Controlled Clinical Trials 18, no. 6 (December 1997): 550–56. http://dx.doi.org/10.1016/s0197-2456(97)00075-5.

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Le Tourneau, C., S. Michiels, H. Gan, and L. Siu. "Reporting of endpoints and tracking of failures in randomized trials of radiotherapy or concurrent chemoradiotherapy for locally advanced head and neck squamous cell cancer (LA-HNSCC)." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 6072. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.6072.

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6072 Background: Due to their anatomical complexity, the interactive effects of multiple treatment modalities, the difficulties in differentiating scar tissues versus residual disease and second cancers versus tumor recurrence, LA-HNSCC represent a challenging disease for the reporting of endpoints and the tracking of failures. Methods: We retrieved all randomized trials that began accrual on or after 1978, and enrolled previously untreated nonmetastatic HNSCC patients receiving primary (chemo)radiotherapy. The reporting of endpoints and the tracking of failures in these trials were analyzed. Failures were defined as events meeting a pre-specified endpoint definition. Results: Forty trials involving 13,892 patients fulfilled our inclusion criteria. A total of 125 endpoints were identified: primary versus secondary = 34:91, survival-based (e.g., overall survival [OS]) versus surrogate (e.g. locoregional control [LRC]) = 47:78. In 6 trials, no primary endpoint was identified. LRC and OS accounted for 70% of primary endpoints. All but one trial reported at least one secondary endpoint, with a median of 2 per trial (range: 0–5), and as many as 17 different types of secondary endpoints were reported. Among 72 endpoints tracking locoregional failures, 21/72 (29%) did not define locoregional failure, while 46/72 (64%) specified the absence of complete response as a failure. Whether salvage surgery or elective node dissection was performed or not was reported in less than half of the trials. Furthermore, it was usually not specified if residual disease found during these procedures would account for failure or not. The means (i.e. clinical and/or radiological examinations) to ascertain failures and the protocol-specified timing to track failures were reported in 41% and 67% of surrogate endpoints, respectively. The tracking of other types of failure beyond the first failure is not reported by any of the trials. The reporting of second cancers was found in 15/40 (38%) trials, whereas the duration of follow-up was quantified in 31/40 (78%) trials. Conclusions: These results demonstrate the vast heterogeneity in endpoint reporting and tracking of failures in clinical trials of LA-HNSCC. No significant financial relationships to disclose.
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O'Mahony, Denis, Adalsteinn Gudmundsson, Roy L. Soiza, Mirko Petrovic, Alfonso Jose Cruz-Jentoft, Antonio Cherubini, Richard Fordham, et al. "Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial." Age and Ageing 49, no. 4 (June 2, 2020): 605–14. http://dx.doi.org/10.1093/ageing/afaa072.

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Abstract Background Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. Methods We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. Results For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77–1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). Conclusions In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.
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Lupón, Josep, Evelyn Santiago-Vacas, Germán Cediel, Pau Codina, Mar Domingo, Elena Revuelta-López, Elisabet Zamora, et al. "Circulating neprilysin hypothesis: A new opportunity for sacubitril/valsartan in patients with heart failure and preserved ejection fraction?" PLOS ONE 16, no. 5 (May 14, 2021): e0249674. http://dx.doi.org/10.1371/journal.pone.0249674.

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Background Circulating Neprilysin (sNEP) has emerged as a potential prognostic biomarker in heart failure (HF). In PARAGON-HF benefit of sacubitril/valsartan was only observed in patients with left ventricular ejection fraction (LVEF) ≤57%. We aimed to assess the prognostic value of sNEP in outpatients with HF and LVEF >57%, in comparison with patients with LVEF ≤57%. Methods Consecutive HF outpatients were included from May-2006 to February-2016. The primary endpoint was the composite of all-cause death or HF hospitalization and the main secondary endpoint was the composite of cardiovascular death or HF hospitalization. For the later competing risk methods were used. Results sNEP was measured in 1428 patients (age 67.7±12.7, 70.3% men, LVEF 35.8% ±14), 144 of which had a LVEF >57%. sNEP levels did not significantly differ between LVEF groups (p = 0.31). During a mean follow-up of 6±3.9 years, the primary endpoint occurred in 979 patients and the secondary composite endpoint in 714 (in 111 and 84 of the 144 patients with LVEF >57%, respectively). sNEP was significantly associated with both composite endpoints. Age- and sex- adjusted Cox regression analyses showed higher hazard ratios for sNEP in patients with LVEF >57%, both for the primary (HR 1.37 [1.16–1.61] vs. 1.04 [0.97–1.11]) and the secondary (HR 1.38 [1.21–1.55] vs. 1.11 [1.04–1.18]) composite endpoints. Conclusions sNEP prognostic value in patients with HF and LVEF >57% outperforms that observed in patients with lower LVEF. Precision medicine using sNEP may identify HF patients with preserved LVEF that may benefit from treatment with sacubitril/valsartan.
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Davis, C. E. "Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical significance." Controlled Clinical Trials 18, no. 6 (December 1997): 557–60. http://dx.doi.org/10.1016/s0197-2456(96)00133-x.

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Easton, J. Donald, Hans Denison, Scott R. Evans, Mikael Knutsson, Pierre Amarenco, Gregory W. Albers, Per Ladenvall, et al. "Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial." International Journal of Stroke 14, no. 9 (May 15, 2019): 908–14. http://dx.doi.org/10.1177/1747493019851282.

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Background Adjudication of endpoints is a standard procedure in cardiovascular clinical trials. However, several studies indicate that the benefit of adjudication in estimating treatment effect may be limited. Aims This post hoc analysis of SOCRATES (NCT01994720) compared the treatment effects and investigated the agreement of clinical event assessment by site investigators and independent adjudicators. Methods SOCRATES compared ticagrelor and aspirin in 13,199 patients with acute minor stroke or high-risk transient ischemic attack. The primary endpoint was stroke, myocardial infarction, or death. Stroke was the major component of the primary endpoint and a secondary endpoint. The endpoints were adjudicated by a blinded independent committee. We compared the treatment effect on the primary endpoint and stroke alone based on the investigators' and adjudicators' assessments, and investigated the agreement rate on the stroke endpoint and major hemorrhages. Results The hazard ratios (95% confidence interval) for ticagrelor versus aspirin therapy for the primary endpoint were 0.89 (0.78–1.01) when calculated on adjudicator-assessed events and 0.88 (0.78–1.00) for investigator-assessed events. The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75–0.99) based on the adjudicators' diagnoses and 0.85 (0.75–0.97) based on the investigators' diagnoses. The overall agreement between adjudicator- and investigator-diagnosed stroke was 91%, and for major hemorrhages was 88%. Conclusions In SOCRATES, there was no clinically meaningful difference in the estimated treatment effect, on either the primary endpoint or stroke, by using investigator- or adjudicator-assessed events. Double-blind treatment outcome studies with stroke endpoints may not benefit from adjudication. Trial Registration ClinicalTrials.gov Identifier: NCT01994720.
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Li, Huiling, Jianming Wang, Xiaolong Luo, Janis Grechko, and Christopher Jennison. "Improved two-stage group sequential procedures for testing a secondary endpoint after the primary endpoint achieves significance." Biometrical Journal 60, no. 5 (June 7, 2018): 893–902. http://dx.doi.org/10.1002/bimj.201700231.

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Hoh, Brian L., Yan Gong, Caitrin W. McDonough, Michael F. Waters, Adrienne J. Royster, Tiffany O. Sheehan, Ben Burkley, et al. "CYP2C19 and CES1 polymorphisms and efficacy of clopidogrel and aspirin dual antiplatelet therapy in patients with symptomatic intracranial atherosclerotic disease." Journal of Neurosurgery 124, no. 6 (June 2016): 1746–51. http://dx.doi.org/10.3171/2015.6.jns15795.

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OBJECT Symptomatic intracranial atherosclerotic disease (ICAD) has a high risk of recurrent stroke. Genetic polymorphisms in CYP2C19 and CES1 are associated with adverse outcomes in cardiovascular patients, but have not been studied in ICAD. The authors studied CYP2C19 and CES1 single-nucleotide polymorphisms (SNPs) in symptomatic ICAD patients. METHODS Genotype testing for CYP2C19*2, *3, *8, *17 and CES1 G143E was performed on 188 adult symptomatic ICAD patients from 3 medical centers who were medically managed with clopidogrel and aspirin. Testing was performed prospectively at 1 center, and retrospectively from a DNA sample biorepository at 2 centers. Multiple logistic regression and Cox regression analysis were performed to assess the association of these SNPs with the primary endpoint, which was a composite of transient ischemic attack (TIA), stroke, myocardial infarction, or death within 12 months. RESULTS The primary endpoint occurred in 14.9% of the 188 cases. In multiple logistic regression analysis, the presence of the CYP2C19 loss of function (LOF) alleles *2, *3, and *8 in the medically managed patients was associated with lower odds of primary endpoint compared with wild-type homozygotes (odds ratio [OR] 0.13, 95% CI 0.03–0.62, p = 0.0101). Cox regression analysis demonstrated the CYP2C19 LOF carriers had a lower risk for the primary endpoint, with hazard ratio (HR) of 0.27 (95% CI 0.08–0.95), p = 0.041. A sensitivity analysis of a secondary composite endpoint of TIA, stroke, or death demonstrated a significant trend in multiple logistic regression analysis of CYP2C19 variants, with lower odds of secondary endpoint in patients carrying at least 1 LOF allele (*2, *3, *8) than in wild-type homozygotes (OR 0.27, 95% CI 0.06–1.16, p = 0.078). Cox regression analysis demonstrated that the carriers of CYP2C19 LOF alleles had a lower risk forthe secondary composite endpoint (HR 0.22, 95% CI 0.05–1.04, p = 0.056). CONCLUSIONS This is the first study examining genetic variants and their effects in symptomatic ICAD. Variant alleles of CYP2C19 (*2, *3, *8) were associated with lower odds of the primary and secondary composite endpoints. However, the direction of the association was opposite of what is expected based on this SNP. This may reflect an incomplete understanding of this genetic variation and its effect in symptomatic ICAD and warrants further investigations.
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Dissertations / Theses on the topic "Secondary endpoint"

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Liu, Yi. "Testing for Efficacy for Primary and Secondary Endpoints by Partitioning Decision Paths." The Ohio State University, 2009. http://rave.ohiolink.edu/etdc/view?acc_num=osu1259598621.

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Turkoz, Ibrahim. "BLINDED EVALUATIONS OF EFFECT SIZES IN CLINICAL TRIALS: COMPARISONS BETWEEN BAYESIAN AND EM ANALYSES." Diss., Temple University Libraries, 2013. http://cdm16002.contentdm.oclc.org/cdm/ref/collection/p245801coll10/id/234528.

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Statistics
Ph.D.
Clinical trials are major and costly undertakings for researchers. Planning a clinical trial involves careful selection of the primary and secondary efficacy endpoints. The 2010 draft FDA guidance on adaptive designs acknowledges possible study design modifications, such as selection and/or order of secondary endpoints, in addition to sample size re-estimation. It is essential for the integrity of a double-blind clinical trial that individual treatment allocation of patients remains unknown. Methods have been proposed for re-estimating the sample size of clinical trials, without unblinding treatment arms, for both categorical and continuous outcomes. Procedures that allow a blinded estimation of the treatment effect, using knowledge of trial operational characteristics, have been suggested in the literature. Clinical trials are designed to evaluate effects of one or more treatments on multiple primary and secondary endpoints. The multiplicity issues when there is more than one endpoint require careful consideration for controlling the Type I error rate. A wide variety of multiplicity approaches are available to ensure that the probability of making a Type I error is controlled within acceptable pre-specified bounds. The widely used fixed sequence gate-keeping procedures require prospective ordering of null hypotheses for secondary endpoints. This prospective ordering is often based on a number of untested assumptions about expected treatment differences, the assumed population variance, and estimated dropout rates. We wish to update the ordering of the null hypotheses based on estimating standardized treatment effects. We show how to do so while the study is ongoing, without unblinding the treatments, without losing the validity of the testing procedure, and with maintaining the integrity of the trial. Our simulations show that we can reliably order the standardized treatment effect also known as signal-to-noise ratio, even though we are unable to estimate the unstandardized treatment effect. In order to estimate treatment difference in a blinded setting, we must define a latent variable substituting for the unknown treatment assignment. Approaches that employ the EM algorithm to estimate treatment differences in blinded settings do not provide reliable conclusions about ordering the null hypotheses. We developed Bayesian approaches that enable us to order secondary null hypotheses. These approaches are based on posterior estimation of signal-to-noise ratios. We demonstrate with simulation studies that our Bayesian algorithms perform better than existing EM algorithm counterparts for ordering effect sizes. Introducing informative priors for the latent variables, in settings where the EM algorithm has been used, typically improves the accuracy of parameter estimation in effect size ordering. We illustrate our method with a secondary analysis of a longitudinal study of depression.
Temple University--Theses
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Parabiaghi, Alberto. "Aripiprazole, olanzapine and haloperidol in the long-term treatment of schizophrenia : the rationale & development of the GiSAS pragmatic randomized controlled trial, a consideration and empirical study of factors associated with recruitment (the GiSAS survey) and the concept of endpoints using a secondary analysis of existing data and a preliminary analysis of GiSAS trial data." Thesis, Open University, 2011. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.578709.

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This thesis described the development of a pragmatic, randomized clinical trial evaluating the safety and efficacy of antipsychotic treatment in schizophrenia. In the perspective of highlighting some critical issues of the trial design, the thesis focused on the trial's planning and conduct and on the preliminary analysis of the first followed-up subjects. Having experienced significant problems in patient recruitment a survey on perceived inclusion barriers and antipsychotic preference was performed. Investigators mainly complained about system-related barriers, and believed in the superiority of second-generation antipsychotics. Taking the cue from these results, strategies were adopted in order to reach the planned target of 800 subjects. Remedial actions included study promotion activities, education initiatives and bursaries, and resulted in a significant improvement of the recruitment rate. Nevertheless, we had to reduce the sample to one third of the original size. The second part of the thesis focused on the concept of end points using a secondary analysis of existing data and a preliminary analysis of GiSAS trial data. The assumption that differences in discontinuation rates reflect differences in effectiveness was reinforced by the results of a pharmaco-epidemiological study comparing the use of reboxetine and SSRIs in a large population sample. The established lack of efficacy of this antidepressant was mirrored by a higher proportion of treatment discontinuations. We explored the baseline characteristics of 114 included subjects and compared the baseline and follow-up variables between those who discontinued study drugs at follow-up and those who did not. Discontinuers' worse outcome was mainly attributable to self reported side-effects. This thesis highlighted some critical issues on the execution of a pragmatic trial in schizophrenia. The feasibility of the trial design and the concept of endpoints were critically analyzed. The trial mechanism is now fully functional and most problems of its implementation have been identified and contained.
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Books on the topic "Secondary endpoint"

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Foley, Richard. Secondary Differences. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190865122.003.0003.

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This chapter argues that inquiries in the sciences ideally move toward an endpoint, a definitive account that is accurate and complete, and on which there is consensus, whereas issues in the humanities are open-ended, with major new insights and revisions always to be expected. While progress in the sciences is movement toward an agreed-upon endpoint, progress in the humanities is toward greater precision, breadth, and coherence, with individual progress highly prized even when it does not lead to consensus. The chapter also argues there are other differences. While the sciences tend to rely on deference to expert authority and to value simple theories, the humanities are more wary of deference and simplicity. The methods of the sciences, which minimize indexicality and perspectivality, and place value on discoveries of conscious phenomena derived from information not steeped in mentality, are not well suited to produce insights about the variety of human experience, whereas the humanities make use of considerations heavily inflected with mentality and hence are better able to produce insights about human experiences and perspectives.
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Foley, Richard. The Geography of Insight. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190865122.001.0001.

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This book, based on a philosopher’s experiences as dean over almost two decades, argues it is appropriate for the sciences and humanities to have different aims and for the values informing their inquiries also to be different. It maintains there are four core differences: (1) it is proper for the sciences but not the humanities to seek insights not limited to particular locations, times, or things; (2) the sciences but not the humanities value findings as independent as possible of the perspectives of the inquirers; (3) the sciences should be wholly descriptive while the humanities can also be concerned with prescriptive claims, which give expression to values; and (4) the sciences are organized to increase collective knowledge, whereas in the humanities individual insight is highly valued independently of its ability to generate consensus. Associated with these differences are secondary distinctions: different attitudes about an endpoint of inquiry; different notions of intellectual progress; different roles for expertise; different assumptions about simplicity and complexity; and different approaches to issues associated with consciousness. Taken together these distinctions constitute an intellectual geography of the humanities and sciences: a mapping of key features of their epistemology. In addition, the book discusses the role of universities in an era attached to sound bites and immediately useful results, and the importance of there being a healthy culture of research for both the sciences and humanities, one that treasures long-term intellectual achievements and whose presiding value is that with respect to many issues it ought not to be easy to have opinions.
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J, Raiten Daniel, and Talbot John M, eds. Clinical trials for the treatment of secondary wasting and cachexia: Selection of appropriate endpoints : proceedings of a workshop, May 22-23, 1997. Bethesda, MD: American Society for Nutritional Sciences, 1999.

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J, Raiten Daniel, and Talbot John M, eds. Clinical trials for the treatment of secondary wasting and cachexia: Selection of appropriate endpoints : proceedings of a workshop, May 22-23, 1997. Bethesda, MD: American Society for Nutritional Sciences, 1999.

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Jansen, Tim C., and Jan Bakker. Lactate monitoring in the ICU. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0139.

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An increased blood lactate level (hyperlactataemia) is commonplace in critically-ill patients. Lactate is usually measured with the aim of detecting tissue hypoxia, but this is an oversimplification as aerobic processes can also result in increased levels. Understanding of the various anaerobic and aerobic mechanisms of production and clearance is essential for the correct interpretation of hyperlactataemia. Despite the broad differential diagnosis, hyperlactataemia generally predicts adverse outcomes. The consistency of its prognostic value emphasizes its place in the risk stratification of critically-ill patients. Lactate clearance was non-inferior to central venous oxygen saturation as a goal of early resuscitation in patients presenting to the emergency department with severe sepsis or septic shock. Therapy guidance by lactate monitoring significantly reduced hospital mortality in ICU patients admitted with hyperlactataemia after adjustment for predefined risk factors, a finding consistent with important secondary endpoints. These results confirm that lactate monitoring offers clinical benefit and should be incorporated within a goal-directed therapy strategy.
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Book chapters on the topic "Secondary endpoint"

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Gou, Jiangtao, and Oliver Y. Chén. "Critical Boundary Refinement in a Group Sequential Trial When the Primary Endpoint Data Accumulate Faster Than the Secondary Endpoint." In Contemporary Biostatistics with Biopharmaceutical Applications, 205–24. Cham: Springer International Publishing, 2019. http://dx.doi.org/10.1007/978-3-030-15310-6_11.

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Nelson, Peter R. "Primary and Secondary Endpoints." In Clinical Trials Design in Operative and Non Operative Invasive Procedures, 11–20. Cham: Springer International Publishing, 2017. http://dx.doi.org/10.1007/978-3-319-53877-8_2.

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DeMets, David L., and Charles H. Hennekens. "Data Monitoring for the Aspirin Component of the Physicians’ Health Study: Issues in Early Termination for a Major Secondary Endpoint." In Data Monitoring in Clinical Trials, 73–84. New York, NY: Springer US, 2006. http://dx.doi.org/10.1007/0-387-30107-0_7.

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Wang, Dayong. "Endpoints for Assessing the Toxicity on Secondary Targeted Organs." In Exposure Toxicology in Caenorhabditis elegans, 181–258. Singapore: Springer Singapore, 2020. http://dx.doi.org/10.1007/978-981-15-6129-0_8.

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Higgins, S. L. "New Evidence from the Secondary Endpoints of the MADIT II Study." In Cardiac Arrhythmias 2003, 469–74. Milano: Springer Milan, 2004. http://dx.doi.org/10.1007/978-88-470-2137-2_61.

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Porzsolt, Franz. "Lessons Learned from Prevention Programs: Different Endpoints Should Be Used in Secondary and Tertiary Prevention." In Clinical Cancer Prevention, 11–20. Berlin, Heidelberg: Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-642-10858-7_2.

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Barosi, Giovanni, and Gianni Tognoni. "Clinical trials in myeloproliferative neoplasms." In Oxford Specialist Handbook: Myeloproliferative Neoplasms, 286–304. Oxford University Press, 2020. http://dx.doi.org/10.1093/med/9780198744214.003.0018.

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In this chapter we discuss the benefits and limitations of trial endpoints used for myeloproliferative neoplasms (MPN) treatment. In myelofibrosis (MF), improvement in overall survival (OS) was a secondary endpoint in three randomized trials, with confounding results related to sample size, trial duration, and treatment choices after progression. Progression-free survival was a secondary endpoint in one trial with a greater clinical impact with respect to OS, but the reflection of its benefit on OS was not demonstrated. Overall response rate was widely used in MPN, however, it reflects heterogeneous objective benefits for the patients and biological rationales. In essential thrombocythaemia and polycythaemia vera (PV), event-free survival documented the capacity of therapies to prevent thrombotic occurrences, reflecting clinically relevant benefit to patients. Patient-reported outcomes were secondary endpoints in MF and PV, and their support to change in ORR was the reason of drug approval by regulatory agencies.
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Thomas, Gregory S., and L. Samuel Wann. "Nuclear Cardiology." In Ellestad's Stress Testing, edited by Gregory S. Thomas, L. Samuel Wann, and Myrvin H. Ellestad, 289–325. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190225483.003.0015.

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The Nuclear Cardiology chapter reviews the opportunity to increase sensitivity and specificity of stress testing for the diagnosis of coronary artery disease with exercise or pharmacologic myocardial perfusion imaging (MPI). Case presentations highlight the concepts presented. Based on the extraction fraction of thallium-201 and technetium-99m sestamibi and tetrofosmin, optimal timing of radioisotope injection at near peak exercise is reviewed. The importance of achieving ≥85% of maximal heart rate or an ischemic endpoint and when to convert to vasodilator testing is discussed. Multiple well-tested protocols are reviewed to add exercise to adenosine or regadenoson to minimize adverse effects and improve imaging quality and throughput. Data from the 1,147 patient EXERRT study are reviewed demonstrating that a technetium-99m radioisotope dose ratio of 1:3 is too low for 1-day low-dose rest/high-dose stress MPI secondary to shine through of the resting study into the stress study. A dose ratio minimum of 1:4 is recommended for 1-day low-dose rest/high-dose stress protocols.
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Foley, Richard. "The Epistemologies of the Humanities and the Sciences." In Varieties of Understanding, 47–66. Oxford University Press, 2019. http://dx.doi.org/10.1093/oso/9780190860974.003.0003.

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In this essay, the author provides an overview of some of the main themes of his book, The Geography of Insight: The Humanities, the Sciences, How They Differ, Why They Matter (2018). In particular, he argues that there are four core differences between the sciences and the humanities: (1) it is proper for the sciences but not the humanities to seek insights not limited to particular locations, times, or things; (2) the sciences but not the humanities value findings as independent as possible of the perspectives of the inquirers; (3) the sciences should be wholly descriptive, while the humanities can also be concerned with prescriptive claims, which give expression to values; and (4) the sciences are organized to increase collective knowledge, whereas in the humanities individual insight is highly valued independently of its ability to generate consensus. Associated with these differences are a set of secondary distinctions: different attitudes about the possibility of endpoint of inquiry; different notions of intellectual progress; different roles for expertise; and different working assumptions about simplicity and complexity.
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Levy, Sean, and Ednan Bajwa. "Efficacy and Safety of Corticosteroids for Persistent Acute Respiratory Distress Syndrome." In 50 Studies Every Intensivist Should Know, edited by Edward A. Bittner and Michael E. Hochman, 152–56. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190467654.003.0025.

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The role of corticosteroids in the treatment of acute respiratory distress syndrome (ARDS), and in particular, those patients with persistent ARDS (defined as > 7 days since onset) has been controversial. In this ARDSNet study, subjects who received corticosteroids had similar outcomes as compared with placebo. Particular harm was seen in subjects with ARDS onset more than 14 days prior to treatment. Overall adverse events were similar between groups, although a higher rate of neuromyopathy was noted in those receiving steroids. Despite these findings, improvements in physiologic parameters and certain secondary endpoints suggest a possible role for steroids, perhaps with a more prolonged tapering of the drug following liberation from mechanical ventilation.
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Conference papers on the topic "Secondary endpoint"

1

Ray, Valery. "High Aspect Ratio via Milling Endpoint Phenomena in Focused Ion Beam Modification of Integrated Circuits." In ISTFA 2004. ASM International, 2004. http://dx.doi.org/10.31399/asm.cp.istfa2004p0658.

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Abstract Precision detection of endpoint after the milling has reached targeted conductor during circuit modification by focused ion beam system is important. While the sensitivity of the endpoint detection can be enhanced by improved secondary electron collection and sample absorbed current monitoring, a detailed understanding of the endpoint signal distribution within a high aspect ratio (HAR) via is of great interest. This article presents an alternative model of HAR via milling endpointing mechanism in which a phenomenon of spatial distribution of the endpoint information within the HAR via is explained based on sputtering of the material from the targeted metal line and redeposition of the spattered material on the via sidewalls. Increased emission of the secondary electrons, resulting from the subsequent bombardment of this conductive re-deposition by the primary ion beam, is detected as the endpoint. A methodology for the future experimental verification of the proposed model is also described.
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Ray, Valery, Nicholas Antoniou, Alex Krechmer, and Andrew Saxonis. "Improvements of Secondary Electron Imaging and Endpoint Detection in Focused Ion Beam Circuit Modification." In ISTFA 2003. ASM International, 2003. http://dx.doi.org/10.31399/asm.cp.istfa2003p0338.

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Abstract Secondary electron signal is widely used in Focused Ion Beam (FIB) systems for imaging and endpointing. In the application of integrated circuit modification, technology has progressed towards smaller dimensions and higher aspect ratios. Therefore, FIB based circuit modification processes require the use of primary ion beam currents below 10 pA and Gas Assisted Etching (GAE). At low beam currents, short pixel dwell times and high aspect ratios, the level of available secondary electrons for detection has declined significantly. FIB GAE and deposition requires delivery and release of a gaseous agent near the beam scanning area, and involves insertion of a gas delivery nozzle made of conductive material and grounded for charge prevention purposes. The proximity of a grounded gas delivery nozzle to the area being milled and/or imaged creates a “shielding” effect, further lowering secondary electron signal level. The application of a small positive bias to the gas delivery nozzle provides an effective way of reducing the “shielding” effect. Depending on the geometrical arrangement of the gas delivery system and other conductive objects in the chamber, an optimized nozzle bias potential can create conditions favorable for enhanced extraction and collection of secondary electrons. The level of the secondary electron image signal, collected in an FEI Vectra 986+ system, from a grounded copper sample with the nozzle extended and biased can be enhanced as much as six times as compared to the grounded nozzle. Secondary electron intensity endpoint is improved on backside samples, however shielding of the nozzle field by the bulk silicon substrate limits the electron extraction effect from within a via. For front side edits the improvement of endpoint signal level can be dramatic. Lateral image offset induced by the electrostatic field of a biased nozzle, can be removed by software position compensation.
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Myers, Joseph, Marsha Abramo, Michael Anderson, and Michael W. Phaneuf. "A Novel Approach for Enhancing Critical FIB Imaging for Failure Analysis and Circuit Edit Applications." In ISTFA 2004. ASM International, 2004. http://dx.doi.org/10.31399/asm.cp.istfa2004p0151.

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Abstract As semiconductor device features continue to decrease in size from merely sub micron to below 100 nanometers it becomes necessary to mill smaller and higher aspect ratio FIB vias with reduced ion beam current. This significantly reduces the number of secondary electrons and ions available for endpoint detection and imaging. In addition FIB gas assisted etching introduces a gas delivery nozzle composed of conductive material. This component is grounded to prevent charge build up during ion beam imaging or milling. The proximity of the nozzle to the sample surface creates a shielding effect which reduces the secondary electron detection level as well [1]. The ability to enhance secondary electron imaging for end point detection is required for successful FIB circuit edit and failure analysis applications on advanced technologies. This paper reviews the results obtained using FIB Assist, an image and signal enhancement product for the FEI / Micrion platform, for critical FIB endpoint determination. Examples of FIB fabricated probe points with 30 x 30 nm FIB vias and circuit edit applications endpointing on metal 1 with high aspect ratio holes are presented.
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Martinez, F. J., K. F. Rabe, G. T. Ferguson, C. Wang, D. Singh, J. A. Wedzicha, R. Trivedi, et al. "Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) All-Cause Mortality Versus LAMA/LABA in COPD: Sensitivity Analysis of All-Cause Mortality (Secondary Endpoint) in the ETHOS Trial with Final Retrieved Vital Status Data." In American Thoracic Society 2020 International Conference, May 15-20, 2020 - Philadelphia, PA. American Thoracic Society, 2020. http://dx.doi.org/10.1164/ajrccm-conference.2020.201.1_meetingabstracts.a4214.

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5

Shahbaz, T. "Irradiation of the secondary star in X-ray Nova Scorpii 1994 (=GRO J1655-40)." In X-RAY ASTRONOMY: Stellar Endpoints,AGN, and the Diffuse X-ray Background. AIP, 2001. http://dx.doi.org/10.1063/1.1434775.

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White, R. James, E. Grünig, C. Jerjes-Sanchez D, G. M. Bohns Meyer, T. Pulido, P. Sepulveda, K. Y. Wang, et al. "Dose-response relationship of oral treprostinil for secondary endpoints in the FREEDOM-EV study." In ERS International Congress 2019 abstracts. European Respiratory Society, 2019. http://dx.doi.org/10.1183/13993003.congress-2019.pa5462.

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LIU, AIYI, CHENGQING WU, and KAI F. YU. "INCORPORATING OVERRUNNING DATA INTO THE ANALYSIS OF BOTH PRIMARY AND SECONDARY ENDPOINTS IN A SEQUENTIAL TRIAL." In Random Walk, Sequential Analysis and Related Topics - A Festschrift in Honor of Yuan-Shih Chow. WORLD SCIENTIFIC, 2006. http://dx.doi.org/10.1142/9789812772558_0004.

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Castellino, SM, SK Parsons, Q. Pei, K. McCarten, S. Kessel, A. Punnett, TM Horton, et al. "A randomized Phase III trial of Brentuximab vedotin (Bv) for de novo High-Risk Classical Hodgkin Lymphoma (cHL) in children and adolescents - Study Design and Incorporation of secondary endpoints in Children’s Oncology Group (COG) AHOD1331." In ISCAYAHL 2020. © Georg Thieme Verlag KG, 2020. http://dx.doi.org/10.1055/s-0040-1701822.

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