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Risk management in clinical trials

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https://www.readbyqxmd.com/read/27935148/customized-versus-population-based-growth-charts-to-identify-neonates-at-risk-of-adverse-outcomes-a-systematic-review-and-bayesian-meta-analysis-of-observational-studies
#1
REVIEW
Giuseppe Chiossi, Claudia Pedroza, Maged M Costantine, Van Thi Thanh Truong, Giancarlo Gargano, George R Saade
OBJECTIVE: To compare the effectiveness of customized versus population-based growth charts for prediction of adverse pregnancy outcomes. METHODS: we searched MEDLINE, http://ClinicalTrials.gov and the Cochrane library up to May 31(st) 2016 to identify interventional and observational studies comparing adverse outcomes among large (LGA) and small (SGA) for gestational age neonates, when classified with customized versus population-based growth charts. We studied perinatal mortality and NICU admission among both SGA and LGA neonates, IUFD and neonatal mortality among SGA, shoulder dystocia, 3(rd) and 4(th) degree perineal lacerations, as well as neonatal hypoglycemia among LGA...
December 9, 2016: Ultrasound in Obstetrics & Gynecology
https://www.readbyqxmd.com/read/27933281/pet-imaging-of-urokinase-type-plasminogen-activator-receptor-upar-in-prostate-cancer-current-status-and-future-perspectives
#2
REVIEW
Dorthe Skovgaard, Morten Persson, Andreas Kjaer
Overexpression of urokinase-type plasminogen activator receptors (uPAR) represents an important biomarker for aggressiveness in most common malignant diseases, including prostate cancer (PC). Accordingly, uPAR expression either assessed directly in malignant PC tissue or assessed directly in plasma (intact/cleaved forms)-provides independent additional clinical information to that contributed by PSA, Gleason score, and other relevant pathological and clinical parameters. In this respect, non-invasive molecular imaging by positron emission tomography (PET) offers a very attractive technology platform, which can provide the required quantitative information on the uPAR expression profile, without the need for invasive procedures and the risk of missing the target due to tumor heterogeneity...
2016: Clinical and Translational Imaging: Reviews in Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/27932413/biomarkers-and-coronary-lesions-predict-outcomes-after-revascularization-in-non-st-elevation-acute-coronary-syndrome
#3
Daniel Lindholm, Stefan K James, Maria Bertilsson, Richard C Becker, Christopher P Cannon, Evangelos Giannitsis, Robert A Harrington, Anders Himmelmann, Frederic Kontny, Agneta Siegbahn, Philippe Gabriel Steg, Robert F Storey, Matthijs A Velders, W Douglas Weaver, Lars Wallentin
BACKGROUND: Risk stratification in non-ST-elevation acute coronary syndrome (NSTE-ACS) is currently mainly based on clinical characteristics. With routine invasive management, angiography findings and biomarkers are available and may improve prognostication. We aimed to assess if adding biomarkers [high-sensitivity cardiac troponin T (cTnT-hs), N-terminal probrain-type natriuretic peptide (NT-proBNP), growth differentiation factor 15 (GDF-15)] and extent of coronary artery disease (CAD) might improve prognostication in revascularized patients with NSTE-ACS...
December 8, 2016: Clinical Chemistry
https://www.readbyqxmd.com/read/27931968/borderline-resectable-pancreatic-cancer-more-than-an-anatomical-concept
#4
Fausto Petrelli, Alessandro Inno, Sandro Barni, Antonio Ghidini, Roberto Labianca, Massimo Falconi, Michele Reni, Stefano Cascinu
Borderline resectable pancreatic cancer (BRPC) accounts for about 10-15% of newly diagnosed pancreatic cancer, and its management requires a skilled multidisciplinary team. The main definition of BRPC refers to resectability, but also a high risk of positive surgical margins and recurrence. This raises questions about the value of surgery and suggests an opportunity to utilize preoperative treatment in this subset of patients. Besides technical borderline resectable disease which is defined on anatomical and radiological criteria, there is also a biological borderline resectable disease which is defined on clinical and biological prognostic factors...
December 5, 2016: Digestive and Liver Disease
https://www.readbyqxmd.com/read/27930630/obesity-and-breast-cancer-risk-outcomes-and-future-considerations
#5
Rachel L Yung, Jennifer A Ligibel
The proportion of adults who are obese has increased dramatically in the United States over the last 30 years. Obesity has been linked to an increased risk of developing a number of malignancies, including postmenopausal breast cancer. Evidence also suggests that obesity at the time of breast cancer diagnosis is linked to an increased risk of breast cancer-specific and overall mortality in both premenopausal and postmenopausal women with early-stage breast cancer. Obesity is linked to an increased risk of secondary malignancies in women with early breast cancer, and studies suggest that weight gain after diagnosis increases overall mortality...
October 2016: Clinical Advances in Hematology & Oncology: H&O
https://www.readbyqxmd.com/read/27928711/dry-weight-assessment-by-combined-ultrasound-and-bioimpedance-monitoring-in-low-cardiovascular-risk-hemodialysis-patients-a-randomized-controlled-trial
#6
Dimitrie Siriopol, Mihai Onofriescu, Luminita Voroneanu, Mugurel Apetrii, Ionut Nistor, Simona Hogas, Mehmet Kanbay, Radu Sascau, Dragos Scripcariu, Adrian Covic
PURPOSE: Fluid overload is associated with adverse outcomes in hemodialysis (HD) patients. The precise assessment of hydration status in HD patients remains a major challenge for nephrologists. Our study aimed to explore whether combining two bedside methods, lung ultrasonography (LUS) and bioimpedance, may provide complementary information to guide treatment in specific HD patients. METHODS: In total, 250 HD patients from two dialysis units were included in this randomized clinical trial...
December 7, 2016: International Urology and Nephrology
https://www.readbyqxmd.com/read/27927041/investigational-agents-for-the-management-of-huntington-s-disease
#7
Thomas Müller
An inherited, chronic progressive, neurodegenerative disorder is Huntington's disease, characterized by motor, cognitive, and psychiatric symptoms. Predictive genetic testing allows earlier diagnosis and identification of gene carriers for Huntington's disease. These individuals are ideal candidates for testing of therapeutic interventions for disease modification. Areas covered: According to queries in Pubmed, Embase and clinical register databases, research and clinical studies emerge on symptomatic and neuroprotective therapies in Huntington's disease...
December 7, 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27927037/clinical-hepatotoxicity-associated-with-antifungal-agents
#8
Ioannis Kyriakidis, Athanasios Tragiannidis, Silke München, Andreas H Groll
Invasive fungal diseases (IFDs) are a leading cause of morbidity and mortality among immunocompromised patients with bone marrow failure syndromes, hematological malignancies, hematopoietic stem cell transplantation (HSCT), those admitted in intensive care units (ICUs) and those with prolonged febrile neutropenia. IFDs occur in a setting of multiple morbidities and are associated with case fatality rates between 30 and 70%. Along with the development of classes and compounds, the last two decades have seen substantial improvements in the prevention and management of these infections and an overall increased use of antifungal agents...
December 7, 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/27923397/pharmacological-interventions-for-delirium-in-intensive-care-patients-a-protocol-for-an-overview-of-reviews
#9
Marija Barbateskovic, Laura Krone Larsen, Marie Oxenbøll-Collet, Janus Christian Jakobsen, Anders Perner, Jørn Wetterslev
BACKGROUND: The prevalence of delirium in intensive care unit (ICU) patients is high. Delirium has been associated with morbidity and mortality including more ventilator days, longer ICU stay, increased long-term mortality and cognitive impairment. Thus, the burden of delirium for patients, relatives and societies is considerable. Today, reviews of randomised clinical trials are produced in large scales sometimes making it difficult to get an overview of the available evidence. A preliminary search identified several reviews investigating the effects of pharmacological interventions for the management and prevention of delirium in ICU patients...
December 7, 2016: Systematic Reviews
https://www.readbyqxmd.com/read/27922501/an-overview-of-congenital-myopathies
#10
Jean K Mah, Jeffrey T Joseph
PURPOSE OF REVIEW: This article uses a case-based approach to highlight the clinical features as well as recent advances in molecular genetics, muscle imaging, and pathophysiology of the congenital myopathies. RECENT FINDINGS: Congenital myopathies refer to a heterogeneous group of genetic neuromuscular disorders characterized by early-onset muscle weakness, hypotonia, and developmental delay. Congenital myopathies are further classified into core myopathies, centronuclear myopathies, nemaline myopathies, and congenital fiber-type disproportion based on the key pathologic features found in muscle biopsies...
December 2016: Continuum: Lifelong Learning in Neurology
https://www.readbyqxmd.com/read/27921324/statins-and-mortality-the-untold-story
#11
Michael S Kostapanos, Moses S Elisaf
Statins are first-line evidence-based drugs for the management of dyslipidaemias and to reduce the risk of cardiovascular events. However, statin clinical trials have shown marginally significant benefits on mortality, especially in the primary prevention setting. A major limitation of those trials is their relatively short follow-up. A reduced number of fatal events within a 5-year follow-up make mortality benefits unlikely to arise. This is particularly relevant for the primary prevention trials, whereby the risk of cardiovascular death is low...
December 6, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27921196/danshen-injection-as-adjuvant-treatment-for-unstable-angina-pectoris-a-systematic-review-and-meta-analysis
#12
Jia-Rui Wu, Shi Liu, Xiao-Meng Zhang, Bing Zhang
OBJECTIVE: To systematically evaluate the clinical effectiveness and safety of Danshen Injection (, DS) as one adjuvant treatment for conventional therapy with Western medicine (WM) for unstable angina pectoris (UAP). METHODS: Using literature databases, a thorough and systematic retrieval of randomized controlled trials (RCTs) comparing DS plus WM with WM was conducted from inception to April 2015. The extracted data from included studies was analyzed by Review Manager 5...
December 5, 2016: Chinese Journal of Integrative Medicine
https://www.readbyqxmd.com/read/27921038/the-clinical-manifestation-and-management-of-autosomal-dominant-polycystic-kidney-disease-in-china
#13
REVIEW
Cheng Xue, Chen-Chen Zhou, Ming Wu, Chang-Lin Mei
BACKGROUND: Autosomal dominant polycystic kidney disease (ADPKD) is the most common monogenic hereditary kidney disease characterized by progressive enlargement of renal cysts. The incidence is 1-2‰ worldwide. Mutations in two genes (PKD1 and PKD2) cause ADPKD. Currently, there is no pharmaceutical treatment available for ADPKD patients in China. Summary: This review focused on advances in clinical manifestation, gene diagnosis, risk factors, and management of ADPKD in China. There is an age-dependent increase in total kidney volume (TKV) and decrease in renal function in Chinese ADPKD patients...
October 2016: Kidney Diseases
https://www.readbyqxmd.com/read/27919120/reconstructive-surgery-for-treating-pressure-ulcers
#14
REVIEW
Jason Kf Wong, Kavit Amin, Jo C Dumville
BACKGROUND: The management of pressure ulcers involves several interventions ranging from pressure-relieving measures such as repositioning, to treatments that can include reconstructive surgery. Such surgery may be considered for recalcitrant wounds when full thickness skin loss arises and deeper structures such as muscle fascia and even bone are exposed. The surgery commonly involves wound debridement followed by the addition of new tissue into the wound. Whilst reconstructive surgery is an accepted means of ulcer management, the benefits and harms of surgery compared with non-surgical treatments, or alternative surgical approaches are not clear...
December 6, 2016: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/27918976/randomized-controlled-trial-of-a-family-oriented-self-management-program-to-improve-self-efficacy-glycemic-control-and-quality-of-life-among-thai-individuals-with-type-2-diabetes
#15
Nutchanath Wichit, George Mnatzaganian, Mary Courtney, Paula Schulz, Maree Johnson
AIMS: We evaluated a theoretically-derived family-oriented intervention aimed to improve self-efficacy, self-management, glycemic control and quality of life in individuals living with Type 2 diabetes in Thailand. METHODS: In a single-blinded randomized controlled trial, 140 volunteer individuals with Type 2 diabetes, recruited from a diabetes clinic in rural Thailand, were randomly allocated to intervention and control arms. Those in the intervention arm received routine care plus a family-oriented program that included education classes, group discussions, a home visit, and a telephone follow-up while the control arm only received routine care...
November 19, 2016: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/27918798/controlled-interventions-to-reduce-burnout-in-physicians-a-systematic-review-and-meta-analysis
#16
Maria Panagioti, Efharis Panagopoulou, Peter Bower, George Lewith, Evangelos Kontopantelis, Carolyn Chew-Graham, Shoba Dawson, Harm van Marwijk, Keith Geraghty, Aneez Esmail
Importance: Burnout is prevalent in physicians and can have a negative influence on performance, career continuation, and patient care. Existing evidence does not allow clear recommendations for the management of burnout in physicians. Objective: To evaluate the effectiveness of interventions to reduce burnout in physicians and whether different types of interventions (physician-directed or organization-directed interventions), physician characteristics (length of experience), and health care setting characteristics (primary or secondary care) were associated with improved effects...
December 5, 2016: JAMA Internal Medicine
https://www.readbyqxmd.com/read/27918781/the-role-of-adjuvant-chemotherapy-in-surgically-managed-p16-positive-oropharyngeal-squamous-cell-carcinoma
#17
S Andrew Skillington, Dorina Kallogjeri, James S Lewis, Jay F Piccirillo
Importance: Human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC) has a favorable prognosis, and p16 immunohistochemistry is a surrogate marker of high-risk HPV infection and strong prognosticator. Given this favorable prognosis, treatment de-escalation for p16-positive OPSCC is now being considered with the goal of decreasing treatment-associated morbidity without compromising tumor control. The role of adjuvant chemotherapy in this setting is becoming increasingly unclear...
December 1, 2016: JAMA Otolaryngology—Head & Neck Surgery
https://www.readbyqxmd.com/read/27918753/axillary-nodal-management-following-neoadjuvant-chemotherapy-a-review
#18
Melissa Pilewskie, Monica Morrow
Importance: The increasing use of neoadjuvant chemotherapy (NAC) for operable breast cancer has raised questions about optimal local therapy for the axilla. Observations: Sentinel lymph node biopsy (SLNB) after NAC in patients presenting with clinically negative nodes has an accuracy similar to upfront SLNB and reduces the need for axillary lymph node dissection compared with SLNB prior to NAC. In patients presenting with node-positive disease, clinical trials demonstrate that SLNB after NAC is accurate when 3 or more sentinel nodes are obtained, but long-term outcomes are lacking...
December 1, 2016: JAMA Oncology
https://www.readbyqxmd.com/read/27917261/anti-hepatitis-c-virus-drugs-and-kidney
#19
REVIEW
Paul Carrier, Marie Essig, Marilyne Debette-Gratien, Denis Sautereau, Annick Rousseau, Pierre Marquet, Jérémie Jacques, Véronique Loustaud-Ratti
Hepatitis C virus (HCV) mainly targets the liver but can also induce extrahepatic manifestations. The kidney may be impacted via an immune mediated mechanism or a cytopathic effect. HCV patients are clearly at a greater risk of chronic kidney disease (CKD) than uninfected patients are, and the presence of CKD increases mortality. Interferon-based therapies and ribavirin are difficult to manage and are poorly effective in end-stage renal disease and hemodialysis. These patients should be given priority treatment with new direct anti-viral agents (DAAs) while avoiding peginterferon and ribavirin...
November 18, 2016: World Journal of Hepatology
https://www.readbyqxmd.com/read/27917150/nurse-led-intervention-to-improve-knowledge-of-medications-in-survivors-of-stroke-or-transient-ischemic-attack-a-cluster-randomized-controlled-trial
#20
Muideen T Olaiya, Dominique A Cadilhac, Joosup Kim, David Ung, Mark R Nelson, Velandai K Srikanth, Christopher F Bladin, Richard P Gerraty, Sharyn M Fitzgerald, Thanh G Phan, Judith Frayne, Amanda G Thrift
INTRODUCTION: Limited evidence exists on effective interventions to improve knowledge of preventive medications in patients with chronic diseases, such as stroke. We investigated the effectiveness of a nurse-led intervention, where a component was to improve knowledge of prevention medications, in patients with stroke or transient ischemic attack (TIA). METHODS: Prospective sub-study of the Shared Team Approach between Nurses and Doctors for Improved Risk Factor Management, a randomized controlled trial of risk factor management...
2016: Frontiers in Neurology
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