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Risk management in clinical trials

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https://www.readbyqxmd.com/read/28550608/shifting-paradigms-in-the-medical-management-of-type-2-diabetes-reflections-on-recent-cardiovascular-outcome-trials
#1
Faramarz Ismail-Beigi, Etie Moghissi, Mikhail Kosiborod, Silvio E Inzucchi
An important challenge in the management of patients with type 2 diabetes is cardiovascular disease (CVD) prevention. While it is well established that intensive glycemic control prevents the onset and slows the progression of certain microvascular complications, such a strategy utilized in multiple clinical trials over the past few decades has failed to show a similar benefit with regard to cardiovascular events, including mortality. Despite this, a major hope has been the discovery of glucose-lowering medications that simultaneously improve cardiovascular outcomes...
May 26, 2017: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/28550009/digital-support-interventions-for-the-self-management-of-low-back-pain-a-systematic-review
#2
Barbara I Nicholl, Louise F Sandal, Mette J Stochkendahl, Marianne McCallum, Nithya Suresh, Ottar Vasseljen, Jan Hartvigsen, Paul J Mork, Per Kjaer, Karen Søgaard, Frances S Mair
BACKGROUND: Low back pain (LBP) is a common cause of disability and is ranked as the most burdensome health condition globally. Self-management, including components on increased knowledge, monitoring of symptoms, and physical activity, are consistently recommended in clinical guidelines as cost-effective strategies for LBP management and there is increasing interest in the potential role of digital health. OBJECTIVE: The study aimed to synthesize and critically appraise published evidence concerning the use of interactive digital interventions to support self-management of LBP...
May 21, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28549439/anesthetic-management-of-cesarean-section-in-cases-of-placenta-accreta-with-versus-without-abdominal-aortic-balloon-occlusion-study-protocol-for-a-randomized-controlled-trial
#3
Qinjun Chu, Dan Shen, Long He, Hongwei Wang, Xianlan Zhao, Zhimin Chen, Yanli Wang, Wei Zhang
BACKGROUND: Placenta accreta (PA), a severe complication during delivery, is closely linked with massive hemorrhage which could endanger the lives of both mother and baby. Moreover, the incidence of PA has increased dramatically with the increasing rate of cesarean deliveries in the past few decades. Therefore, studies evaluating the effects of different perioperative managements based on different modalities in the treatment of PA are necessary. Among the numerous treatment measures, prophylactic abdominal aortic balloon occlusion (AABO) in combination with cesarean section for PA seems to be more advantageous than others...
May 26, 2017: Trials
https://www.readbyqxmd.com/read/28549348/ocular-toxicities-associated-with-targeted-anticancer-agents-an-analysis-of-clinical-data-with-management-suggestions
#4
Chen Fu, Dan S Gombos, Jared Lee, Goldy C George, Kenneth Hess, Andrew Whyte, David S Hong
Ocular toxicities are among the most common adverse events resulting from targeted anticancer agents and are becoming increasingly relevant in the management of patients on these agents. The purpose of this study is to provide a framework for management of these challenging toxicities based on objective data from FDA labels and from analysis of the literature. All oncologic drugs approved by the FDA up to March 14, 2015, were screened for inclusion. A total of 16 drugs (12 small-molecule drugs and 4 monoclonal antibodies) were analyzed for ocular toxicity profiles based on evidence of ocular toxicity...
May 5, 2017: Oncotarget
https://www.readbyqxmd.com/read/28546779/emerging-treatment-options-for-the-management-of-hodgkin-s-lymphoma-clinical-utility-of-nivolumab
#5
REVIEW
David A Bond, Lapo Alinari
Classical Hodgkin's lymphoma (cHL) is a B-cell malignancy comprised of pathologic Reed Sternberg cells with a surrounding immune-tolerant inflammatory milieu. RS cells evade immune recognition in part through programmed death ligand 1 (PD-L1) overexpression, which is genetically programmed through copy number alterations, polysomy, and amplification of the 9p24.1 locus encoding PD-L1. By engaging with PD-1+ T-cells, PD-L1 delivers a potent immune suppressive signal promoting immunologic escape of the tumor cell...
2017: Journal of Blood Medicine
https://www.readbyqxmd.com/read/28546375/extracorporeal-membrane-oxygenation-for-severe-pediatric-respiratory-failure
#6
John C Lin
Extracorporeal membrane oxygenation (ECMO) was developed initially in the 1960s to support refractory respiratory failure in addition to the cardiac support inherent in a venoarterial bypass circuit. Early successes occurred predominantly in the neonatal population with subsequent randomized controlled trials and comprehensive reviews concluding therapeutic efficacy for ECMO in neonatal respiratory failure. In contrast, the evidence supporting ECMO for respiratory failure in children is less definitive. However, although pediatric randomized controlled trials have not been completed, sufficient evidence in support of ECMO as a beneficial therapy for pediatric respiratory failure exists...
June 2017: Respiratory Care
https://www.readbyqxmd.com/read/28545758/the-role-of-affect-management-for-hiv-risk-reduction-for-youth-in-alternative-schools
#7
Larry K Brown, Laura Whiteley, Christopher D Houck, Lacey K Craker, Ashley Lowery, Nancy Beausoleil, Geri Donenberg
OBJECTIVE: Adolescents in alternative schools for behavioral and emotional problems have an earlier sexual onset and higher rates of sexual risk than their peers. They also often have difficulty managing strong emotions, which can impair sexual decision making. Human immunodeficiency virus (HIV) prevention programs for these adolescents may be most effective if skills for coping with strong emotions during sexual situations are included. METHOD: This article reports the 6-month outcomes of a three-arm randomized controlled trial comparing an HIV prevention intervention with affect management (AM) to a standard, skills-based HIV prevention intervention (SB), and a general health promotion intervention (HP)...
June 2017: Journal of the American Academy of Child and Adolescent Psychiatry
https://www.readbyqxmd.com/read/28545542/recognition-and-treatment-of-sleep-disordered-breathing-an-important-component-of-chronic-disease-management
#8
REVIEW
Peter C Farrell, Glenn Richards
Sleep-disordered breathing (SDB) is a highly prevalent condition, and is associated with many debilitating chronic diseases. The role of untreated obstructive sleep apnea (OSA) in arterial hypertension has been recognized in international guidelines. Treatment with continuous positive airway pressure (CPAP) is associated with clinically-relevant reductions in blood pressure. In heart failure (HF), SDB is associated with worse prognosis and increased mortality. Major HF guidelines recommend that patients should be treated for sleep apnea to improve their HF status...
May 25, 2017: Journal of Translational Medicine
https://www.readbyqxmd.com/read/28543286/impact-of-treatment-crossovers-on-clinical-outcomes-in-the-rate-and-rhythm-control-strategies-for-atrial-fibrillation-insights-from-the-affirm-atrial-fibrillation-follow-up-investigation-of-rhythm-management-trial
#9
Abhishek Maan, Zheng Zhang, Ziling Qin, Yanbing Wang, Samuel Dudley, Kaustubh Dabhadakar, Marwan Refaat, Moussa Mansour, Jeremy N Ruskin, E Kevin Heist
We investigated the rates and reasons for crossover to alternative treatment strategies and its impact on mortality in patients who were enrolled in the AFFIRM trial. Over a mean follow-up period of 3.5 years, 842 patients underwent crossover to the alternative treatment arms in AFFIRM. The rate of crossover from rhythm to rate control (594/2033, 29.2%) was more frequent than the rate of crossover from rate to rhythm control (248/2027, 12.2%, p < 0.0001). The leading reasons for crossover from rhythm to rate control were failure to achieve or maintain sinus rhythm (272/594, 45...
May 24, 2017: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/28541026/advances-in-the-management-of-diabetic-neuropathy
#10
Tamás Várkonyi, Anna Körei, Zsuzsanna Putz, Tímea Martos, Katalin Keresztes, Csaba Lengyel, Szabolcs Nyiraty, Alin Stirban, György Jermendy, Péter Kempler
The authors review current advances in the therapy of diabetic neuropathy. The role of glycaemic control and management of cardiovascular risk factors in the prevention and treatment of neuropathic complications are discussed. As further options of pathogenetic ally oriented treatment, recent knowledge on benfotiamine and alpha-lipoic acid is comprehensively reviewed. Alpha-lipoic acid is a powerful antioxidant and clinical trials have proven its efficacy in ameliorating neuropathic signs and symptoms. Benfotiamine acts via the activation of transketolase and thereby inhibits alternative pathways triggered by uncontrolled glucose influx in the cells comprising polyol, hexosamine, protein-kinase-C pathways and formation of advanced glycation end products...
May 25, 2017: Minerva Medica
https://www.readbyqxmd.com/read/28540743/a-review-on-cardiovascular-effects-of-newer-hypoglycemic-medications
#11
B Tate Cutshall, Jennifer D Twilla, Andrew S Olinger, Carrie S Oliphant
Cardiovascular disease is the most prevalent cause of morbidity and mortality in diabetic patients. Improvement in cardiovascular complications with glycemic control and managing cardiovascular risk factors is well established. However, the impact of hypoglycemic medications on cardiovascular disease is of increasing importance. In 2008 the U.S. Food and Drug Administration issued study regulations for hypoglycemic agents after rosiglitazone was shown to increase the incidence of myocardial infarction, and the European Medicines Agency provided their own guidance in 2012...
May 25, 2017: Annals of Medicine
https://www.readbyqxmd.com/read/28540118/spinal-cord-injury-in-the-geriatric-population-risk-factors-treatment-options-and-long-term-management
#12
REVIEW
Tochukwu C Ikpeze, Addisu Mesfin
Spinal cord injuries (SCIs) are sustained by more than 12 500 patients per year in the United States and more globally. The SCIs disproportionately affect the elderly, especially men. Approximately 60% of these injuries are sustained traumatically through falls, but nontraumatic causes including infections, tumors, and medication-related epidural bleeding have also been documented. Preexisting conditions such as ankylosing spondylitis and diffuse idiopathic skeletal hyperostosis can render the spine stiff and are risk factors as well as cervical spondylosis and ensuing cervical stenosis...
June 2017: Geriatric Orthopaedic Surgery & Rehabilitation
https://www.readbyqxmd.com/read/28540073/viscoelastic-testing-inside-and-beyond-the-operating-room
#13
REVIEW
Liang Shen, Sheida Tabaie, Natalia Ivascu
Hemorrhage is a major contributor to morbidity and mortality during the perioperative period. Current methods of diagnosing coagulopathy have various limitations including long laboratory runtimes, lack of information on specific abnormalities of the coagulation cascade, lack of in vivo applicability, and lack of ability to guide the transfusion of blood products. Viscoelastic testing offers a promising solution to many of these problems. The two most-studied systems, thromboelastography (TEG) and rotational thromboelastometry (ROTEM), offer similar graphical and numerical representations of the initiation, formation, and lysis of clot...
April 2017: Journal of Thoracic Disease
https://www.readbyqxmd.com/read/28540038/effectiveness-of-paliperidone-depot-injection-in-seriously-violent-men-with-comorbid-schizophrenia-and-dissocial-personality-disorder-in-a-uk-high-security-hospital
#14
Anna-Marie Mortlock, Fintan Larkin, Callum C Ross, Nitin Gupta, Samrat Sengupta, Mrigendra Das
BACKGROUND: High-security hospital patients are often complex in presentation and are characterized by treatment resistance, medication nonadherence and history of violence. Paliperidone is licensed both as an oral and depot antipsychotic medication in the treatment of schizophrenia. Clinical trials have shown that paliperidone depot is well tolerated with similar efficacy to risperidone depot but with additional practical advantages. Whilst data exist for the effectiveness of paliperidone palmitate (PP), there are no studies involving patients in forensic settings or those with comorbid personality disorder...
May 2017: Therapeutic Advances in Psychopharmacology
https://www.readbyqxmd.com/read/28539568/clinical-and-hemodynamic-effects-of-endothelin-receptor-antagonists-in-patients-with-heart-failure
#15
Bo Xiong, Dan Nie, Yin Cao, Yanke Zou, Yuanqing Yao, Jie Tan, Jun Qian, Shunkang Rong, Chunbin Wang, Jing Huang
The clinical benefit of endothelin receptor antagonists (ERA) for the management of heart failure (HF) remains controversial. To examine this question, we performed a meta-analysis of randomized controlled trials (RCTs) to investigate the clinical and hemodynamic effects of ERA in HF patients.We searched the PubMed, Medline, Embase, and Cochrane Library from inception to March 20, 2016 to identify the pertinent studies. Risk ratio (RR) and weighted mean difference (WMD) were calculated using a fixed or random effect model...
May 23, 2017: International Heart Journal
https://www.readbyqxmd.com/read/28539213/medical-management-of-asymptomatic-carotid-artery-stenosis
#16
REVIEW
Aaron W Aday, Joshua A Beckman
Carotid artery atherosclerosis is a major risk factor for both stroke and cardiovascular disease. Appropriate management of asymptomatic patients with carotid artery stenosis (CAS) remains unclear. Although several randomized clinical trials support revascularization in asymptomatic patients with severe CAS to reduce stroke risk, the participants in these trials did not receive optimal medical therapy (OMT) by today's standards. For many individuals, medical therapy may provide excellent risk reduction without the periprocedural risk of endarterectomy or stenting...
May 21, 2017: Progress in Cardiovascular Diseases
https://www.readbyqxmd.com/read/28539175/moxibustion-for-the-treatment-of-osteoarthritis-an-updated-systematic-review-and-meta-analysis
#17
REVIEW
Tae-Young Choi, Myeong Soo Lee, Jong In Kim, Christopher Zaslawski
The aim of this study was to update previous reviews and examine recent evidence from randomised clinical trials (RCTs) of the use of moxibustion for osteoarthritis (OA). Twelve databases were searched from inception through to September 2016 with no language limits applied. Data extraction and risk-of-bias assessments were performed by two independent reviewers. A total of 19 RCTs met all inclusion criteria and were evaluated. Three RCTs compared the effects of moxibustion with those of sham moxibustion in patients with knee OA (KOA) and found favourable effects of moxibustion on pain reduction (n=305; SMD, -0...
June 2017: Maturitas
https://www.readbyqxmd.com/read/28538404/pregabalin-can-decrease-acute-pain-and-morphine-consumption-in-laparoscopic-cholecystectomy-patients-a-meta-analysis-of-randomized-controlled-trials
#18
Shijie Li, Junqiang Guo, Fangjun Li, Zhijia Yang, Shuai Wang, Changjiang Qin
BACKGROUND: Pregabalin has been used as an adjunct for the management of acute pain in laparoscopic cholecystectomy. This meta-analysis aimed to illustrate the efficacy and safety of pregabalin for pain management following laparoscopic cholecystectomy. METHODS: In March 2017, a systematic computer-based search was conducted in PubMed, EMBASE, Web of Science, Cochrane Database of Systematic Reviews, and Google databases. Data on patients prepared for laparoscopic cholecystectomy in studies that compared pregabalin versus placebo were retrieved...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28538363/the-effect-of-alpha-linolenic-acid-on-glycemic-control-in-individuals-with-type-2-diabetes-a-systematic-review-and-meta-analysis-of-randomized-controlled-clinical-trials
#19
Elena Jovanovski, Dandan Li, Hoang Vi Thanh Ho, Vladimir Djedovic, Any de Castro Ruiz Marques, Esra Shishtar, Sonia Blanco Mejia, John L Sievenpiper, Russell J de Souza, Lea Duvnjak, Vladimir Vuksan
BACKGROUND: Polyunsaturated fats (PUFAs) have been shown to reduce type 2 diabetes (T2DM) risk and improve insulin responsiveness in T2DM subjects, but whether the plant sources of omega-3 PUFA (alpha-linolenic acid [ALA]) have an effect on glycemic control requires further investigation. METHODS: The parameters of interest were glycated hemoglobin (HbA1c), fasting blood glucose (FBG), fasting blood insulin (FBI), homeostatic model assessment for insulin resistance (HOMA-IR), fructosamine, and glycated albumin...
May 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28536886/biomarkers-and-non-invasive-tests-for-gastrointestinal-mucositis
#20
REVIEW
N S S Kuiken, E H H M Rings, N M A Blijlevens, Wim J E Tissing
Gastrointestinal mucositis is a complex inflammatory reaction of the mucous membranes, a side effect of both chemotherapy and radiotherapy. Currently, assessment scales are used to diagnose mucositis. However, a biomarker which would determine whether there is mucositis and thereby establish the severity objectively would be very useful. This will give the opportunity to evaluate studies, to determine risk factors and incidence, and it will make it possible to compare studies. Moreover, this biomarker might improve clinical management for patients...
May 24, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
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