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Showing "Revance Announces BELMONT Phase Clinical Data Presented 2017" PubMed Articles 1–25 of 60,000+

Advances in Clinical Cardiology 2017: A Summary of Key Clinical Trials.

Numerous important cardiology clinical trials have been published or presented at major international meetings during 2017. This paper aims to summarize these trials and place them in clinical context.

Profound Intraoperative Hypotension Associated With Transfusion via the Belmont Fluid Management System.

This retrospective observational case series conducted at 2 large academic centers over a 4-year period consists of 15 cases of profound hypotension in surgical patients immediately after initiation of the Belmont Fluid Management System for rapid transfusion of blood products. Halting the infusion and administering vasoactive agents led to resolution of hypotension. Repeat transfusion with the Belmont system resulted in repeat hypotension unless counteracted with vasopressors. No etiology was elucidated. T...

The hard road to data interpretation: three or six months of adjuvant chemotherapy for patients with stage III colon cancer?

Six months of adjuvant oxaliplatin-based chemotherapy is standard for patients with stage III colon cancer following surgery. However, oxaliplatin is associated with peripheral neurotoxicity which worsens over treatment duration. Consequently, a shorter treatment duration, if equally effective would be extremely beneficial. A pooled analysis of data for 12,834 stage III colon cancer patients, from six randomised phase III trials of adjuvant therapy, the IDEA study, was performed and the results presented at...

Developments in urologic oncology "OncoForum": The best of 2017.

To put forth new findings of urologic oncology with impact on clinical practice presented during 2017 in the main annual meetings.

Innovation at the Intersection of Clinical Trials and Real-World Data Science to Advance Patient Care.

While efficacy and safety data collected from randomized clinical trials are the evidentiary standard for determining market authorization, this alone may no longer be sufficient to address the needs of key stakeholders (regulators, providers, and payers) and guarantee long-term success of pharmaceutical products. There is a heightened interest from stakeholders on understanding the use of real-world evidence (RWE) to substantiate benefit-risk assessment and support the value of a new drug. This review prov...

Comment on Hall et al. (2017), "How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial".

The purpose of this letter, in response to Hall, Mehta, and Fackrell (2017), is to provide important knowledge about methodology and statistical issues in assessing the reliability and validity of an audiologist-administered tinnitus loudness matching test and a patient-reported tinnitus loudness rating.

National surveys on 15 quality indicators for the total testing process in clinical laboratories of China from 2015 to 2017.

Background As effective quality management tools, quality indicators (QIs) are widely used in laboratory medicine. This study aimed to analyze the results of QIs, identify errors and provide quality specifications (QSs) based on the state-of-the-art. Methods Clinical laboratories all over China participated in the QIs survey organized by the National Health Commission of People' Republic of China from 2015 to 2017. Most of these QIs were selected from a common model of QIs (MQI) established by the Internati...

Harnessing the Power of Big Data to Improve Graduate Medical Education: Big Idea or Bust?

With the advent of electronic medical records (EMRs) fueling the rise of big data, the use of predictive analytics, machine learning, and artificial intelligence are touted as transformational tools to improve clinical care. While major investments are being made in using big data to transform health care delivery, little effort has been directed toward exploiting big data to improve graduate medical education (GME). Because our current system relies on faculty observations of competence, it is not unreason...

Interpretation of clinical endpoints in trials of acute myeloid leukemia.

Treatment regimens for acute myeloid leukemia (AML) have remained largely unchanged until recently. Molecular advances have opened the door to targeted therapies, many of which are in late-phase clinical trials. As new therapeutic opportunities arise, it is appropriate to review key aspects of clinical trial design, statistical interpretation of outcomes, and methods of data reporting. Complete remission and overall survival (OS) are common primary endpoints in early-phase AML clinical trials. OS and event-...

Advanced bladder cancer : From chemo- to immunotherapy.

In November 2016, the results of a phase III clinical trial with the protein cell death (PD)-1 inhibitor pembrolizumab for second-line treatment of metastatic urothelial carcinoma were published and showed an overall survival benefit in comparison with conventional chemotherapy with vinflunine, docetaxel, or paclitaxel. In a similar trial the PD-L1 antibody atezolizumab showed no significant benefit in comparison to chemotherapy in the subgroup of PD-L1-positive patients and, thus, missed its primary end...

Phase-synchronous undersampling in nonlinear spectroscopy.

We introduce the concept of phase-synchronous undersampling in nonlinear spectroscopy. The respective theory is presented and validated experimentally in a phase-modulated quantum beat experiment by sampling high phase modulation frequencies with low laser repetition rates. The advantage of undersampling in terms of signal quality and reduced acquisition time is demonstrated, and breakdown conditions are identified. The presented method is particularly beneficial for experimental setups with limited signal/...

A systematic review of patient reported outcomes in phase II or III clinical trials of myelodysplastic syndromes and acute myeloid leukemia.

The purpose of this systematic literature review was to identify clinical trials of MDS and AML that included patient-reported outcome (PRO) instruments, and to summarize the symptom and other health related quality of life (HRQOL) concepts most frequently assessed and the PRO instruments that were used. Sixteen manuscripts describing 14 distinct trials met all criteria (i.e., phase 2 or 3 clinical trial for MDS or AML which included PRO assessment) and were published between 1996-2017. In trials evaluating...

Quality of reporting in oncology phase II trials: A 5-year assessment through systematic review.

Phase II clinical trials are a cornerstone of the development in experimental treatments They work as a "filter" for phase III trials confirmation. Surprisingly the attrition ratio in Phase III trials in oncology is significantly higher than in any other medical specialty. This suggests phase II trials in oncology fail to achieve their goal. Objective The present study aims at estimating the quality of reporting in published oncology phase II clinical trials.

Proceedings of the 2017 International Forum on Gonococcal Infections and Resistance (2017 IFGIR) in Shenzhen, China.

The 2017 International Forum on Gonococcal Infections and Resistance (2017 IFGIR) was held at Shenzhen, China from 17 to 19 September 2017. The key objectives were to gather experts in the field to review and analyze the epidemiological profiles of gonococcal infections and antimicrobial resistance (AMR) at global, regional and national levels; to share and discuss findings from ongoing and completed research studies; and to identify research needs to respond to the spread of gonococcal infections and AMR. ...

ASCO- and ESMO-update 2017 - highlights of the 53. meeting of the American Society of Clinical Oncology/ASCO 2017 and European Society for Medical Oncology/ESMO congress 2017.

At ASCO 2017, and subsequently the ESMO congress 2017, a number of studies were presented which, in part, may change the present standard of therapy in gastrointestinal oncology. The German FLOT4 trial established perioperative Docetaxel, Oxaliplatin and 5-Fluorouracil (5-FU) as the new treatment standard for resectable adenocarcinoma of the gastroesophageal junction and the stomach. In hepatocellular carcinoma (HCC), two large studies did not show a survival benefit for selective internal therapy (SIRT), s...

Comment on 'Age of enlightenment: long-term effects of outdoor aesthetic lights on bats in churches'.

This comment reanalyses the data presented in Rydell (Rydell 2017 R. Soc. open. sci.4, 161077. (doi:10.1098/rsos.161077)) which were analysed using only very basic statistics like Fisher's exact test and McNemar's test. We demonstrate how the use of more advanced statistical methods can make better use of the available data, quantify the observed effects and strengthen the conclusions in Rydell (Rydell 2017 R. Soc. open. sci.4, 161077. (doi:10.1098/rsos.161077)). We have no intention to discredit the origin...

Painful shoulder post fall.

CLINICAL INTRODUCTION: A 32-year-old man presented to the ED after a heavy fall on his left shoulder. He presented the following day with pain and gross limitation of movement in the left shoulder. There was no history of previous injury to the left shoulder. This was his non-dominant limb and he worked in a manual occupation. He was neurovascularly intact. His initial radiographs are shown in figures 1 and 2.emermed;emermed-2017-207003v1/F1F1F1Figure 1Anteroposterior radiograph (AP) radiograph of left sh...

VA Announces Plan to Improve Worst-Performing Medical Centers.

An experimental investigation of n-hexane at high temperature and pressure.

At present, no high temperature experiments on phase change are reported. In this study, we have measured the Raman bands ν(CH), ν(CH), ν(CH), and ν(CH) of n-hexane in a hydrothermal diamond cell up to 588 K. We determined that the liquid-solid phase transition pressure of n-hexane is 1.17 GPa, and we also gave a number of high temperatures and pressures data on phase change which are not reported previously. In addition, we defined the solidus of n-hexane which can be represented by the equation P...

EDGE 2017 - Enhanced Data Generated by Electrons, Okinawa, May 2017.

Review article A translational view of cells' secretome analysis - from untargeted proteomic to potential circulating biomarkers.

The identification of circulating biomarkers capable of being used as routine for diagnosis, prognosis, risk stratification and therapeutic monitoring is still the major aim at clinical proteomics. However, the direct search in blood samples or other clinical relevant biofluids is frequently associated with technical limitations that makes the biomarker discovery process extremely difficult when using these types of samples. In this sense, the use of different approaches, such as the analysis of cells' secr...

Author Response to Sabour (2018), "Comment on Hall et al. (2017), 'How to Choose Between Measures of Tinnitus Loudness for Clinical Research? A Report on the Reliability and Validity of an Investigator-Administered Test and a Patient-Reported Measure Using Baseline Data Collected in a Phase IIa Drug Trial'".

The authors respond to a letter to the editor (Sabour, 2018) concerning the interpretation of validity in the context of evaluating treatment-related change in tinnitus loudness over time.

Pre-Data Likelihood Ratios and Bayes Factor Upper Bounds - A Comment on Adams & O'Reilly (2017).

Increasing Sexually Transmitted Infection Testing Through a Coordinated, Community-Wide Approach.

We describe the impact of the Adolescent Health Project on sexually transmitted infection (STI) testing in Omaha, NE, during phase 1 (media campaigns) and phase 2 (free STI testing). To assess the impact of each phase on STI testing, we examined monthly data from January 2013 to April 2017 via interrupted time series analyses. There was an immediate and statistically significant increase in testing during phase 2. Expanding and advertising free STI testing is a promising approach to increasing testing. (Am ...

Summary of the British Association of Paediatric Surgeons (64th) Congress in London, UK July 20th-22nd, 2017.

This is a review of the joint 64th British Association of Paediatric Surgeons (BAPS) and 26th International Pediatric Endosurgery Group (IPEG) Annual Conference, which was held in July 2017, in London, UK. More than 200 papers were presented either orally or as posters in the BAPS section, and it was the largest paediatric surgical conference in Europe in 2017. The congress issue contains papers and posters presented during the open sessions and transcripts based on invited lectures.

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