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00:39 EST 21st February 2019 | BioPortfolio

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Showing "Chimerix Announces Final Data from AdVise Trial Brincidofovir" PubMed Articles 1–25 of 30,000+

mFOLFOX6 plus bevacizumab to treat liver-only metastases of colorectal cancer that are unsuitable for upfront resection (TRICC0808): a multicenter phase II trial comprising the final analysis for survival.

The TRICC0808 trial is a phase II multi-institutional trial that investigated the efficacy of preoperative mFOLFOX6 + bevacizumab (BV) therapy for liver-only metastasis that is unsuitable for upfront resection. The R0 resection rate in the efficacy analysis has been reported to be 44.4%, and the final analysis for survival was conducted (data fixation on February 16, 2015).

Comparison of Methods to Generalize Randomized Clinical Trial Results without Individual-Level Data for the Target Population.

Our study explored the application of methods to generalize randomized controlled trial results to a target population without individual-level data. We compared four methods using aggregate data for the target population to generalize the JUPITER trial results to a target population of trial-eligible patients in Clinical Practice Research Datalink (CPRD). The gold-standard method used individual data from both the trial and CPRD to predict probabilities of being sampled in the trial and reweight trial part...

Three-year clinical outcomes of patients treated with everolimus-eluting bioresorbable vascular scaffolds: Final results of the ABSORB EXTEND trial.

There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial.

Feasibility of data linkage in the PARAMEDIC trial: a cluster randomised trial of mechanical chest compression in out-of-hospital cardiac arrest.

There is considerable interest in reducing the cost of clinical trials. Linkage of trial data to administrative datasets and disease-specific registries may improve trial efficiency, but it has not been reported in resuscitation trials conducted in the UK. To assess the feasibility of using national administrative and clinical datasets to follow up patients transported to hospital following attempted resuscitation in a cluster randomised trial of a mechanical chest compression device in out-of-hospital card...

Deaths: Leading Causes for 2016.

This report presents final 2016 data on the 10 leading causes of death in the United States by age, sex, race, and Hispanic origin. Leading causes of infant, neonatal, and postneonatal death are also presented. This report supplements "Deaths: Final Data for 2016," the National Center for Health Statistics' annual report of final mortality statistics.

Exploring the Effects of Early Censoring and Analysis of Clinical Trial Survival Data on Effectiveness and Cost-Effectiveness Estimation through a Case Study in Advanced Breast Cancer.

Interim analyses of clinical trial data are frequently used to provide evidence to obtain marketing authorization for new drugs. However, results from such analyses may not reflect true estimates of relative effectiveness when trial follow-up is complete. Survival results, available at 2 time points from a breast cancer clinical trial, were compared to test the hypothesis that using immature data and a widely used right-censoring rule leads to biased survival estimates. Kaplan-Meier progression-free and ove...

Leave-One-Trial-Out, LOTO, a general approach to link single-trial parameters of cognitive models to neural data.

It has become a key goal of model-based cognitive neuroscience to estimate trial-by-trial fluctuations of cognitive model parameters for linking these fluctuations to brain signals. However, previously developed methods were limited by being difficulty to implement, time-consuming, or model-specific. Here, we propose an easy, efficient and general approach to estimating trial-wise changes in parameters: Leave-One-Trial-Out (LOTO). The rationale behind LOTO is that the difference between parameter estimates ...

Deaths: Final Data for 2016.

This report presents final 2016 data on U.S. deaths, death rates, life expectancy, infant mortality, and trends, by selected characteristics such as age, sex, Hispanic origin and race, state of residence, and cause of death.

NAPOLI-1 phase 3 study of liposomal irinotecan in metastatic pancreatic cancer: Final overall survival analysis and characteristics of long-term survivors.

Liposomal irinotecan (nal-IRI) plus 5-fluorouracil and leucovorin (5-FU/LV) is approved for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC) previously treated with gemcitabine-based therapy. This approval was based on significantly improved median overall survival compared with 5-FU/LV alone (6.1 vs 4.2 months; hazard ratio [HR], 0.67) in the global phase 3 NAPOLI-1 trial. Here, we report the final survival analysis and baseline characteristics associated with long-term survivors (survival...

Interpreting clinical trial data in multiple myeloma: translating findings to the real-world setting.

Substantial improvements in survival have been seen in multiple myeloma (MM) over recent years, associated with the introduction and widespread use of multiple novel agents and regimens, as well as the emerging treatment paradigm of continuous or long-term therapy. However, these therapies and approaches may have limitations in the community setting, associated with toxicity burden, patient burden, and other factors including cost. Consequently, despite improvements in efficacy in the rigorously controlled ...

Modified power prior with multiple historical trials for binary endpoints.

Including historical data may increase the power of the analysis of a current clinical trial and reduce the sample size of the study. Recently, several Bayesian methods for incorporating historical data have been proposed. One of the methods consists of specifying a so-called power prior whereby the historical likelihood is downweighted with a weight parameter. When the weight parameter is also estimated from the data, the modified power prior (MPP) is needed. This method has been used primarily when a sing...

A Multisite Case Study of Caregiver Advise, Record, Enable Act Implementation.

The Commonwealth of Pennsylvania passed the Caregiver Advise, Record, Enable (CARE) Act on April 20, 2016. We designed a study to explore early implementation at a large, integrated delivery financing system. Our goal was to assess the effects of system-level decisions on unit implementation and the incorporation of the CARE Act's three components into routine care delivery.

Measuring Satisfaction with Deployment in the Final Year of Undergraduate Medical Study (Ma-FEZ-PJ) to Ensure the Quality of Training in the Final Year - Psychometrics of a Self-Evaluation Questionnaire.

One way to recruit junior physicians in surgery is to optimise the final year. Starting points for this can be gained through a standardised evaluation of the deployments in the final year. In this study, a questionnaire for the evaluation of the training conditions and satisfaction with the deployment in the final year (Ma-FEZ-PJ) underwent a test and item analysis. In addition, initial studies were carried out to analyse the construct validity of the two scales - final year training and individual attitud...

Choroideremia Gene Therapy Phase 2 Clinical Trial: 24-Month Results.

To report the final results of a phase 2 high-dose gene therapy clinical trial in choroideremia.

Cardiac-sparing whole lung imrt in patients with pediatric tumors and lung metastasis: Final report of a prospective multicenter clinical trial.

A prospective clinical trial was conducted for patients undergoing cardiac sparing (CS) whole lung irradiation (WLI) using IMRT. The 3 trial aims were: 1) To demonstrate the feasibility of CS IMRT with real time central quality control; 2) To determine the dosimetric advantages of WLI using IMRT compared to standard antero-posterior (AP) techniques; and 3) To determine acute tolerance and short-term efficacy after a protocol mandated minimum 2 year follow up for all patients.

Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome and Posterior Probability of Mortality Benefit in a Post Hoc Bayesian Analysis of a Randomized Clinical Trial.

Bayesian analysis of clinical trial data may provide useful information to aid in study interpretation, especially when trial evidence suggests that the benefits of an intervention are uncertain, such as in a trial that evaluated early extracorporeal membrane oxygenation (ECMO) for severe acute respiratory distress syndrome (ARDS).

Cytokine, glycemic and insulinemic responses to an acute bout of games-based activity in adolescents.

An acute bout of endurance exercise in adults stimulates a same-day anti-inflammatory response which may affect low-grade chronic inflammation and insulin resistance and benefit cardio-metabolic health. The anti-inflammatory responses to intermittent games-based exercise and to exercise in young people beyond 2-h post-exercise are unknown. Thus, the purpose of the present study is to examine the anti-inflammatory, glycemic and insulinemic response to games-based activity in adolescents. Following ethical ap...

Implementation of Ask-Advise-Connect in a safety net healthcare system: quitline treatment engagement and smoking cessation outcomes.

Ask-Advise-Connect (AAC) was designed to link smokers in primary care settings with evidence-based tobacco treatment delivered via state quitlines. AAC involves training medical staff to Ask about smoking status, Advise smokers to quit, and offer to immediately Connect smokers with quitlines through an automated link within the electronic health record. We evaluated the efficacy of AAC in facilitating treatment engagement and smoking abstinence in a 34 month implementation trial conducted in a large, safety...

Rapid Intervention Through Telephone Encounters for Blood Pressure Control by Residents in an Outpatient Resident Clinic.

Introduction Sixty-seven million Americans have hypertensionthat costs the nation $47.5 billion each year. The aim of this study was to determine if regular phone calls by residents helped achieve better blood pressure control. Methods The study was a randomized open-labeled study in a resident-run outpatient clinic in Rochester, New York. A total of 57 poorly controlled hypertensives in the clinic were divided into two groups. All the patients received scheduled phone calls once every two weeks for a total...

Effect of intensive blood pressure lowering on cardiovascular outcomes based on cardiovascular risk: A secondary analysis of the SPRINT trial.

Background It is not clear whether risk stratification can help choose the most favourable systolic blood pressure target for primary prevention of cardiovascular events. Design A secondary analysis of Systolic Blood Pressure Intervention Trial (SPRINT). Methods To perform a secondary analysis, we obtained the data from SPRINT from the National Heart, Lung, and Blood Institute data repository centre. In SPRINT, an open-label trial, participants without diabetes with systolic blood pressure of ≥130 mmHg we...

Comparison between patients included in randomized controlled trials of ischemic heart disease and real-world data. A nationwide study.

The objective was to compare patients with ischemic heart disease (IHD) undergoing percutaneous coronary intervention (PCI) who were included in randomized controlled trials (RCTs) (trial participants) with patients who were not included (nonparticipants) on a trial-by-trial basis and according to indication for PCI.

A multicentre randomized pilot trial on the effectiveness of different levels of cooling in comatose survivors of out-of-hospital cardiac arrest: the FROST-I trial.

To obtain initial data on the effect of different levels of targeted temperature management (TTM) in out-of-hospital cardiac arrest (OHCA).

Food Effect Study Design With Oral Drugs: Lessons Learned From Recently Approved Drugs in Oncology.

Evaluation of the effect of food on the pharmacokinetics of oral oncology drugs is critical to drug development, as food can mitigate or exacerbate toxicities and alter systemic exposure. Our aim is to expand on current US Food and Drug Administration (FDA) guidance and provide data-driven food-effect study design recommendations specific to the oncology therapeutic area. Data for recently approved small-molecule oncology drugs was extracted from the clinical pharmacology review in the sponsor's FDA submiss...

Propensity-score-based priors for Bayesian augmented control design.

Drug developers are required to demonstrate substantial evidence of effectiveness through the conduct of adequate and well-controlled (A&WC) studies to obtain marketing approval of their medicine. What constitutes A&WC is interpreted as the conduct of randomized controlled trials (RCTs). However, these trials are sometimes unfeasible because of their size, duration, and cost. One way to reduce sample size is to leverage information on the control through a prior. One consideration when forming data-driven p...

An Update on the European Lung Cancer Screening Trials and Comparison of Lung Cancer Screening Recommendations in Europe.

While lung cancer screening has been implemented in the United States, it is still under consideration in Europe. So far, lung cancer screening trials in Europe were not able to replicate the results of the National Lung Screening Trial, but they do show a stage shift in the lung cancers that were detected. While eagerly awaiting the final result of the only lung cancer screening trial with sufficient statistical power, the NELSON trial, a number of European countries and medical societies have published re...

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