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Risk management in clinical trials

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https://www.readbyqxmd.com/read/29346679/risk-stratification-in-takotsubo-syndrome-a-role-of-mitral-annular-plane-systolic-excursion
#1
Ibrahim El-Battrawy, Uzair Ansari, Siegfried Lang, Christian Fastner, Xiaobo Zhou, Martin Borggrefe, Ibrahim Akin
Aims: Takotsubo syndrome (TTS) patients have a higher mortality rate than the general population. Our study was conducted to determine the short- and long-term outcome of TTS patients associated with a significantly compromised mitral annular plane systolic excursion (MAPSE) on hospital admission. Methods and results: Our institutional database constituted a collective of 53 patients diagnosed with TTS between 2003 and 2016. The patients were classified into two groups based on the MAPSE, with those presenting with a MAPSE <1 cm on admission categorized into one group (n = 20, 38%) and those presenting with MAPSE ≥1 cm (n = 33, 62%) categorized into another group...
January 15, 2018: QJM: Monthly Journal of the Association of Physicians
https://www.readbyqxmd.com/read/29346184/synergistic-impact-of-training-followed-by-on-site-support-on-hiv-clinical-practice-a-mixed-design-study-in-uganda-with-pre-post-and-cluster-randomized-trial-components
#2
Sarah Burnett, Norbert Mubiru, Peace Imani, Martin K Mbonye, Leigh Fisher, Robert Colebunders, Yukari C Manabe, Marcia R Weaver
BACKGROUND: Task-shifting can expand antiretroviral therapy access, but little is known about effective approaches to improve clinical practice among mid-level practitioners' (MLP) such as clinical officers, nurses, and midwives. The Integrated Infectious Diseases Capacity-Building Evaluation compared training alone to training combined with on-site support (OSS). METHODS: Two MLP each from 36 health facilities attended the five-week Integrated Management of Infectious Disease training...
January 16, 2018: Journal of Acquired Immune Deficiency Syndromes: JAIDS
https://www.readbyqxmd.com/read/29346126/complete-revascularization-for-patients-with-st-segment-elevation-myocardial-infarction-and-multivessel-coronary-artery-disease-a-meta-analysis-of-randomized-trials
#3
Gani Bajraktari, Haki Jashari, Pranvera Ibrahimi, Fernando Alfonso, Fisnik Jashari, Gjin Ndrepepa, Shpend Elezi, Michael Y Henein
INTRODUCTION: Despite the recent findings in randomized clinical trials (RCTs) with limited sample sizes and the updates in clinical guidelines, the current available data for the complete revascularization (CR) in hemodynamically stable patients with ST-segment elevation myocardial infarction (STEMI) at the time of primary percutaneous coronary intervention (PCI) are still contradictory. AIM: The aim of this meta-analysis of the existing RCTs was to assess the efficacy of the CR versus revascularization of infarct-related artery (IRA) only during primary PCI in patients with STEMI and multivessel disease (MVD)...
January 17, 2018: Coronary Artery Disease
https://www.readbyqxmd.com/read/29345505/the-pharmacological-management-of-metabolic-syndrome
#4
Julie Rask Larsen, Lorena Dima, Christoph U Correll, Peter Manu
Introduction The metabolic syndrome includes a constellation of several well-established risk factors, which need to be aggressively treated in order to prevent overt type 2 diabetes and cardiovascular disease. While recent guidelines for the treatment of individual components of the metabolic syndrome focus on cardiovascular benefits as resulted from clinical trials, specific recent recommendations on the pharmacological management of metabolic syndrome are lacking. The objective of present paper was to review the therapeutic options for metabolic syndrome and its components, the available evidence related to their cardiovascular benefits, and to evaluate the extent to which they should influence the guidelines for clinical practice...
January 18, 2018: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/29345042/a-systematic-review-of-community-based-interventions-for-the-treatment-of-adolescents-with-overweight-and-obesity
#5
REVIEW
C J Moores, L K Bell, J Miller, R A Damarell, L Matwiejczyk, M D Miller
Adolescent obesity is a risk factor for obesity and other chronic disease in adulthood. Evidence for the effectiveness of community-based obesity treatment programs for adolescents is required to inform policy and clinical decisions. This systematic review aims to evaluate recent effective and scalable community-based weight management programs for adolescents (13-17 years) who are overweight or obese. Eight databases (Medline, Embase, PsycINFO, CINAHL, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Informit, and Scopus) were searched for studies published between January 2011-2 March 2017 which are scalable in a community setting and reported primary outcome measures relating to weight...
January 17, 2018: Obesity Reviews: An Official Journal of the International Association for the Study of Obesity
https://www.readbyqxmd.com/read/29344950/systematic-review-and-meta-analysis-of-left-ventricular-endocardial-pacing-in-advanced-heart-failure-clinically-efficacious-but-at-what-cost
#6
Adam Graham, Rui Providenica, Shohreh Honarbakhsh, Neil Srinivasan, Vinit Sawhney, Ross Hunter, Pier Lambiase
INTRODUCTION: Cardiac resynchronization using a left ventricular (LV) epicardial lead placed in the coronary sinus is now routinely used in management of heart failure patients. LV endocardial pacing is an alternative when this is not feasible, with outcomes data sparse. OBJECTIVE: To review the available evidence on the efficacy and safety of endocardial LV pacing via meta-analysis. METHODS: EMBASE, MEDLINE and COCHRANE databases with the search term "endocardial biventricular pacing" or "endocardial cardiac resynchronization" or "left ventricular endocardial" or "endocardial left ventricular"...
January 18, 2018: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/29344342/frontotemporal-dementia-latest-evidence-and-clinical-implications
#7
REVIEW
Juan Joseph Young, Mallika Lavakumar, Deena Tampi, Silpa Balachandran, Rajesh R Tampi
Background: Frontotemporal dementia (FTD) describes a cluster of neurocognitive syndromes that present with impairment of executive functioning, changes in behavior, and a decrease in language proficiency. FTD is the second most common form of dementia in those younger than 65 years and is expected to increase in prevalence as the population ages. This goal in our review is to describe advances in the understanding of neurobiological pathology, classification, assessment, and treatment of FTD syndromes...
January 2018: Therapeutic Advances in Psychopharmacology
https://www.readbyqxmd.com/read/29343412/implementing-genome-driven-personalized-cardiology-in-clinical-practice
#8
REVIEW
Ares Pasipoularides
Genomics designates the coordinated investigation of a large number of genes in the context of a biological process or disease. It may be long before we attain comprehensive understanding of the genomics of common complex cardiovascular diseases (CVDs) such as inherited cardiomyopathies, valvular diseases, primary arrhythmogenic conditions, congenital heart syndromes, hypercholesterolemia and atherosclerotic heart disease, hypertensive syndromes, and heart failure with preserved/reduced ejection fraction. Nonetheless, as genomics is evolving rapidly, it is constructive to survey now pertinent concepts and breakthroughs...
January 14, 2018: Journal of Molecular and Cellular Cardiology
https://www.readbyqxmd.com/read/29343280/pregabalin-versus-placebo-in-targeting-pro-nociceptive-mechanisms-to-prevent-chronic-pain-after-whiplash-injury-in-at-risk-individuals-a-feasibility-study-for-a-randomised-controlled-trial
#9
J Nikles, G Keijzers, G Mitchell, S Schug, R Ware, S A McLean, L Connelly, S Gibson, S F Farrell, M Sterling
BACKGROUND: Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin's effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated...
January 17, 2018: Trials
https://www.readbyqxmd.com/read/29341850/clinical-inertia-in-a-randomized-trial-of-telemedicine-based-chronic-disease-management-lessons-learned
#10
Anna Beth Barton, Daniel E Okorodudu, Hayden B Bosworth, Matthew J Crowley
BACKGROUND: Treatment nonadherence and clinical inertia perpetuate poor cardiovascular disease (CVD) risk factor control. Telemedicine interventions may counter both treatment nonadherence and clinical inertia. INTRODUCTION: We explored why a telemedicine intervention designed to reduce treatment nonadherence and clinical inertia did not improve CVD risk factor control, despite enhancing treatment adherence versus usual care. METHODS: In this analysis of a randomized trial, we studied recipients of the 12-month telemedicine intervention...
January 17, 2018: Telemedicine Journal and E-health: the Official Journal of the American Telemedicine Association
https://www.readbyqxmd.com/read/29341162/impact-of-genomics-on-the-surgical-management-of-melanoma
#11
REVIEW
P M Ferguson, G V Long, R A Scolyer, J F Thompson
BACKGROUND: Although surgery for early-stage melanoma offers the best chance of cure, recent advances in molecular medicine have revolutionized the management of late-stage melanoma, leading to significant improvements in clinical outcomes. Research into the genomic drivers of disease and cancer immunology has not only ushered in a new era of targeted and immune-based therapies for patients with metastatic melanoma, but has also provided new tools for monitoring disease recurrence and selecting therapeutic strategies...
January 2018: British Journal of Surgery
https://www.readbyqxmd.com/read/29340938/pharmacologic-treatment-of-hypertensive-urgency-in-the-outpatient-setting-a-systematic-review
#12
Claudia L Campos, Charles T Herring, Asima N Ali, Deanna N Jones, James L Wofford, Augustus L Caine, Robert L Bloomfield, Janine Tillett, Karen S Oles
BACKGROUND: Hypertensive urgency (HU), defined as acute severe uncontrolled hypertension without end-organ damage, is a common condition. Despite its association with long-term morbidity and mortality, guidance regarding immediate management is sparse. Our objective was to summarize the evidence examining the effects of antihypertensive medications to treat. METHODS: We searched the PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Database of Abstracts of Reviews of Effects (DARE), Cochrane Database of Systematic Reviews, Web of Science, Google Scholar, and Embase through May 2016...
January 16, 2018: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/29340109/development-of-a-targeted-sequencing-approach-to-identify-prognostic-predictive-and-diagnostic-markers-in-paediatric-solid-tumours
#13
Elisa Izquierdo, Lina Yuan, Sally George, Michael Hubank, Chris Jones, Paula Proszek, Janet Shipley, Susanne A Gatz, Caedyn Stinson, Andrew S Moore, Steven C Clifford, Debbie Hicks, Janet C Lindsey, Rebecca M Hill, Thomas S Jacques, Jane Chalker, Khin Thway, Simon O'Connor, Lynley Marshall, Lucas Moreno, Andrew Pearson, Louis Chesler, Brian A Walker, David Gonzalez De Castro
The implementation of personalised medicine in childhood cancers has been limited by a lack of clinically validated multi-target sequencing approaches specific for paediatric solid tumours. In order to support innovative clinical trials in high-risk patients with unmet need, we have developed a clinically relevant targeted sequencing panel spanning 311 kb and comprising 78 genes involved in childhood cancers. A total of 132 samples were used for the validation of the panel, including Horizon Discovery cell blends (n=4), cell lines (n=15), formalin-fixed paraffin embedded (FFPE, n=83) and fresh frozen tissue (FF, n=30) patient samples...
December 19, 2017: Oncotarget
https://www.readbyqxmd.com/read/29339917/association-of-treatment-adherence-with-real-life-va-outcomes-in-amd-dme-and-brvo-patients
#14
Christoph Ehlken, Mandy Helms, Daniel Böhringer, Hansjürgen T Agostini, Andreas Stahl
Purpose: Real-life clinical outcomes of patients treated with anti-VEGF drugs for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), or macular edema secondary to branch retinal vein occlusion (BRVO) are often inferior to results from randomized clinical trials. This observational cohort study investigates treatment adherence and real-life clinical outcomes within the first year of treatment. Patients and methods: A total of 708 treatment-naïve patients (466 nAMD, 134 DME, and 108 BRVO) were included...
2018: Clinical Ophthalmology
https://www.readbyqxmd.com/read/29339351/high-target-vs-low-target-blood-pressure-management-during-cardiopulmonary-bypass-to-prevent-cerebral-injury-in-cardiac-surgery-patients-a-randomized-controlled-trial
#15
Anne G Vedel, Frederik Holmgaard, Lars S Rasmussen, Annika Langkilde, Olaf B Paulson, Theis Lange, Carsten Thomsen, Peter Skov Olsen, Hanne Berg Ravn, Jens C Nilsson
Background -Cerebral injury is an important complication following cardiac surgery with the use of cardiopulmonary bypass (CPB). The rate of overt stroke after cardiac surgery is 1-2%, whereas silent strokes, detected by diffusion-weighed magnetic resonance imaging (DWI), are found in up to 50% of patients. It is unclear if a higher versus a lower blood pressure during cardiopulmonary bypass reduces cerebral infarction in these patients. Methods -In a patient- and assessor-blinded randomized trial, we allocated patients to a higher (70-80 mmHg) or lower (40-50 mmHg) target for mean arterial pressure by the titration of norepinephrine during cardiopulmonary bypass...
January 16, 2018: Circulation
https://www.readbyqxmd.com/read/29339169/the-timing-of-p2y12-inhibitor-initiation-in-the-treatment-of-acs-does-the-evidence-exist-in-this-era
#16
REVIEW
Harsh Golwala, Deepak L Bhatt
The majority of acute coronary syndromes (ACS) are well characterized as a consequence of plaque rupture and subsequent thrombosis. Antiplatelet agents targeting inhibition of P2Y12 receptors on the platelets have shown to reduce future risk of cardiovascular events in this patient population. However, the timing of initiation of these agents, in particular, in patients managed with invasive strategy with percutaneous coronary interventions (PCI) is debatable. The data supporting pretreatment with antiplatelet agents prior to PCI in ACS patients dates to trials performed >15 years ago, wherein the time to PCI was >5 days, and henceforth, the utility of pretreatment with these agents in the contemporary era remains uncertain...
January 12, 2018: Progress in Cardiovascular Diseases
https://www.readbyqxmd.com/read/29339046/stereotactic-body-radiation-therapy-sbrt-for-high-risk-prostate-cancer-where-are-we-now
#17
REVIEW
Alejandro Gonzalez-Motta, Mack Roach
PURPOSE: Stereotactic body radiation therapy (SBRT) is increasingly being used for the management of localized prostate cancer. This trend combined with declining use of brachytherapy (BT) has pushed issues and questions regarding the use of SBRT to the forefront. A systematic literature review was conducted to review the current evidence of biochemical disease-free survival (bDFS) and toxicity of SBRT in high-risk (HR) prostate cancer. METHODS AND MATERIALS: A search was carried out on the PubMed and Embase databases...
December 2, 2017: Practical Radiation Oncology
https://www.readbyqxmd.com/read/29338978/non-risk-adapted-surveillance-for-stage-i-testicular-cancer-critical-review-and-summary
#18
REVIEW
Phillip Martin Pierorazio, Peter Albers, Peter C Black, Torgrim Tandstad, Axel Heidenreich, Nicola Nicolai, Craig Nichols
CONTEXT: Cancer-specific survival for men with clinical stage I testicular cancer (CSITC) is uniformly excellent. Non-risk-adapted active surveillance (NRAS) is a management strategy for CSITC to minimize overtreatment and avoid possible long-term side effects of adjuvant therapy. OBJECTIVE: To review the evidence regarding oncologic outcomes for men with CSITC undergoing NRAS and discuss ongoing controversies in the management of CSITC. EVIDENCE ACQUISITION: MEDLINE/PubMed, Embase, and the Cochrane Central Register of Controlled Trials were searched from January 1, 1987 through January 1, 2017...
January 12, 2018: European Urology
https://www.readbyqxmd.com/read/29338431/medically-induced-hypertension-hypervolaemia-and-haemodilution-for-the-treatment-and-prophylaxis-of-vasospasm-following-aneurysmal-subarachnoid-haemorrhage-systematic-review
#19
James J M Loan, Anthony N Wiggins, Paul M Brennan
PURPOSE: Arterial vasospasm is a major cause of death and long-term disability following subarachnoid haemorrhage (SAH). The use of medically induced hypertension, hypervolaemia and/or haemodilution is widely practiced for prophylaxis and treatment of vasospasm following SAH. We aimed to determine if the quality of available research is adequate to inform use of haemodynamic management strategies to prevent or treat vasospasm following SAH. METHODS: Individual searches of the following databases were conducted: The Cochrane Database of Systematic Reviews, The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and OpenSIGLE...
January 17, 2018: British Journal of Neurosurgery
https://www.readbyqxmd.com/read/29335858/effects-of-aidi-injection-with-western-medical-therapies-on-quality-of-life-for-patients-with-primary-liver-cancer-a-systematic-review-and-meta-analysis
#20
Li Liu, Jian Liang, Xin Deng
OBJECTIVE: To evaluate the effects of Aidi Injection (, AD) in combination with Western medical therapies (WMT) in patients with primary liver cancer (PLC). METHODS: Randomized controlled trials (RCTs) comparing AD plus WMT with WMT alone were retrieved from inception to March 2013 by retrieving the literature database thoroughly and systematically. The extracted data from included studies were analyzed and synthesized by Review Manager 5.2 software. The Cochrane risk of bias tool was used to assess the quality of included studies, and Begg's and Egger's tests were used to evaluate the potential presence of publication bias...
January 15, 2018: Chinese Journal of Integrative Medicine
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