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Risk management in clinical trials

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https://www.readbyqxmd.com/read/28654958/the-impact-of-whole-genome-sequencing-on-the-primary-care-and-outcomes-of-healthy-adult-patients-a-pilot-randomized-trial
#1
Jason L Vassy, Kurt D Christensen, Erica F Schonman, Carrie L Blout, Jill O Robinson, Joel B Krier, Pamela M Diamond, Matthew Lebo, Kalotina Machini, Danielle R Azzariti, Dmitry Dukhovny, David W Bates, Calum A MacRae, Michael F Murray, Heidi L Rehm, Amy L McGuire, Robert C Green
Background: Whole-genome sequencing (WGS) in asymptomatic adults might prevent disease but increase health care use without clinical value. Objective: To describe the effect on clinical care and outcomes of adding WGS to standardized family history assessment in primary care. Design: Pilot randomized trial. (ClinicalTrials.gov: NCT01736566). Setting: Academic primary care practices. Participants: 9 primary care physicians (PCPs) and 100 generally healthy patients recruited at ages 40 to 65 years...
June 27, 2017: Annals of Internal Medicine
https://www.readbyqxmd.com/read/28651846/molecular-basis-of-%C3%AE-thalassemia-and-potential-therapeutic-targets
#2
REVIEW
Swee Lay Thein
The remarkable phenotypic diversity of β thalassemia that range from severe anemia and transfusion-dependency, to a clinically asymptomatic state exemplifies how a spectrum of disease severity can be generated in single gene disorders. While the genetic basis for β thalassemia, and how severity of the anemia could be modified at different levels of its pathophysiology have been well documented, therapy remains largely supportive with bone marrow transplant being the only cure. Identification of the genetic variants modifying fetal hemoglobin (HbF) production in combination with α globin genotype provide some prediction of disease severity for β thalassemia but generation of a personalized genetic risk score to inform prognosis and guide management requires a larger panel of genetic modifiers yet to be discovered...
June 20, 2017: Blood Cells, Molecules & Diseases
https://www.readbyqxmd.com/read/28651296/early-discharge-hospital-at-home
#3
REVIEW
Daniela C Gonçalves-Bradley, Steve Iliffe, Helen A Doll, Joanna Broad, John Gladman, Peter Langhorne, Suzanne H Richards, Sasha Shepperd
BACKGROUND: Early discharge hospital at home is a service that provides active treatment by healthcare professionals in the patient's home for a condition that otherwise would require acute hospital inpatient care. This is an update of a Cochrane review. OBJECTIVES: To determine the effectiveness and cost of managing patients with early discharge hospital at home compared with inpatient hospital care. SEARCH METHODS: We searched the following databases to 9 January 2017: the Cochrane Effective Practice and Organisation of Care Group (EPOC) register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, and EconLit...
June 26, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28650001/brodalumab-the-first-anti-il-17-receptor-agent-for-psoriasis
#4
L Puig
Psoriasis is a chronic immune-mediated inflammatory skin disease in which the alteration of the interleukin-23 (IL-23)/IL-17 cytokine axis appears to be crucial from a pathogenetic perspective. This has been confirmed by the efficacy of monoclonal antibodies blocking IL-17A, such as secukinumab and ixekizumab. Brodalumab is a human anti-IL-17 receptor A (IL-17RA) monoclonal antibody that inhibits the biological activity of IL-17A, IL-17F and other IL-17 isoforms, and has been approved (210 mg s.c. at weeks 0, 1, 2 and every 2 weeks thereafter) for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma in Japan (Lumicef)...
May 2017: Drugs of Today
https://www.readbyqxmd.com/read/28649802/punctal-occlusion-for-dry-eye-syndrome
#5
REVIEW
Ann-Margret Ervin, Andrew Law, Andrew D Pucker
BACKGROUND: Dry eye syndrome is a disorder of the tear film that is associated with symptoms of ocular discomfort. Punctal occlusion is a mechanical treatment that blocks the tear drainage system in order to aid in the preservation of natural tears on the ocular surface. OBJECTIVES: To assess the effects of punctal plugs versus no punctal plugs, different types of punctal plugs, and other interventions for managing dry eye. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 11), MEDLINE Ovid (1946 to 8 December 2016), Embase...
June 26, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28649643/molecular-stratification-of-early-breast-cancer-identifies-drug-targets-to-drive-stratified-medicine
#6
Jane Bayani, Cindy Q Yao, Mary Anne Quintayo, Fu Yan, Syed Haider, Alister D'Costa, Cassandra L Brookes, Cornelis J H van de Velde, Annette Hasenburg, Dirk G Kieback, Christos Markopoulos, Luc Dirix, Caroline Seynaeve, Daniel Rea, Paul C Boutros, John M S Bartlett
Many women with hormone receptor-positive early breast cancer can be managed effectively with endocrine therapies alone. However, additional systemic chemotherapy treatment is necessary for others. The clinical challenges in managing high-risk women are to identify existing and novel druggable targets, and to identify those who would benefit from these therapies. Therefore, we performed mRNA abundance analysis using the Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial pathology cohort to identify a signature of residual risk following endocrine therapy and pathways that are potentially druggable...
2017: NPJ Breast Cancer
https://www.readbyqxmd.com/read/28649001/a-european-randomised-controlled-trial-of-the-addition-of-etoposide-to-standard-vincristine-and-carboplatin-induction-as-part-of-an-18-month-treatment-programme-for-childhood-%C3%A2-16%C3%A2-years-low-grade-glioma%C3%A2-a-final-report
#7
Astrid K Gnekow, David A Walker, Daniela Kandels, Susan Picton, Giorgio Perilongo, Jacques Grill, Tore Stokland, Per Eric Sandstrom, Monika Warmuth-Metz, Torsten Pietsch, Felice Giangaspero, René Schmidt, Andreas Faldum, Denise Kilmartin, Angela De Paoli, Gian Luca De Salvo
BACKGROUND: The use of chemotherapy to manage newly diagnosed low grade glioma (LGG) was first introduced in the 1980s. One randomised trial has studied two- versus four-drug regimens with a duration of 12 months of treatment after resection. METHODS: Within the European comprehensive treatment strategy for childhood LGG, the International Society of Paediatric Oncology-Low Grade Glioma (SIOP LGG) Committee launched a randomised trial involving 118 institutions and 11 countries to investigate the addition of etoposide (100 mg/m(2), days 1, 2 & 3) to a four-course induction of vincristine (1...
June 22, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28648324/drug-coated-balloon-angioplasty-for-the-management-of-recurring-infrapopliteal-disease-in-diabetic-patients-with-critical-limb-ischemia
#8
Luis M Palena, Larry J Diaz-Sandoval, Efren Gòmez Jabalera, Olga Peypoch Perez, Enrico Sultato, Cesare Brigato, Enrico Brocco, Marco Manzi
OBJECTIVE: To describe the 1-year outcomes of recurring infrapopliteal disease after endovascular revascularization with the Lutonix drug-coated balloons (LDCB) in diabetic patients with critical limb ischemia (CLI), and to benchmark our findings with previously published objective performance goals (OPG) addressing safety and efficacy of new catheter-based therapies for CLI. METHODS: The present study was a retrospective, single-center, and single-arm trial of symptomatic diabetic patients with CLI, who underwent LDCB-angioplasty for recurring infrapopliteal disease...
June 20, 2017: Cardiovascular Revascularization Medicine: Including Molecular Interventions
https://www.readbyqxmd.com/read/28646992/preventive-nephrology-in-the-era-of-i-evidence-should-we-screen-for-chronic-kidney-disease
#9
Carmen A Peralta, Michelle M Estrella
In this issue, Ferguson and colleagues demonstrate that chronic kidney disease (CKD) screening in populations burdened with CKD may be cost effective. Whether we should screen for CKD, however, continues to be debated despite the availability of effective clinical strategies that mitigate the risks of CKD progression. This study highlights the need for pragmatic trials to test the effectiveness of early CKD detection combined with optimization of clinical management and calls for innovation to tackle CKD.
July 2017: Kidney International
https://www.readbyqxmd.com/read/28646932/bcg-a-throwback-from-the-stone-age-of-vaccines-opened-the-path-for-bladder-cancer-immunotherapy
#10
Alvaro Morales
INTRODUCTION: It is 40 years since the initial documentation of the efficacy of bacille Calmette-Guérin (BCG) in the management of non-muscle invasive bladder cancer (NMIBC) and probably an opportune a time as any to retrace the origins of this development and to reflect on the progress that has occurred on the use of immune modifiers in the treatment of NMIBC. MATERIALS AND METHODS: A PubMed search for publications on the history of BCG was conducted, and those related to the development of the vaccine for protection against tuberculosis as well as those published in the last 40 years related to its use for treatment for NMIBC were selected for review...
June 2017: Canadian Journal of Urology
https://www.readbyqxmd.com/read/28646356/pharmacotherapy-in-the-management-of-pediatric-obesity
#11
REVIEW
Aaron S Kelly, Claudia K Fox
PURPOSE OF REVIEW: This review provides a rationale for the use of pharmacotherapy in pediatric weight management, summarizes results of some of the key pediatric clinical trials of approved and "off-label" obesity medications, introduces new options in the pediatric pipeline, and offers a glimpse into the future of pediatric obesity medicine. RECENT FINDINGS: Despite the need for adjunctive treatments to enhance the outcomes of lifestyle modification therapy among youth with obesity, none of the obesity medications evaluated to date have been shown to meaningfully reduce BMI or cardiometabolic risk factors...
August 2017: Current Diabetes Reports
https://www.readbyqxmd.com/read/28645976/a-combined-randomised-and-observational-study-of-surgery-for-fractures-in-the-distal-radius-in-the-elderly-crossfire-a-study-protocol
#12
Ian A Harris, Justine M Naylor, Andrew Lawson, Rachelle Buchbinder, Rebecca Ivers, Zsolt Balogh, Paul Smith, Rajat Mittal, Wei Xuan, Kirsten Howard, Arezoo Vafa, Piers Yates, Bertram Rieger, Geoff Smith, Ilia Elkinson, Woosung Kim, Mellick Chehade, Jai Sungaran, Kim Latendresse, James Wong, Sameer Viswanathan, Martin Richardson, Kush Shrestha, Herwig Drobetz, Phong Tran, Jeremy Loveridge, Richard Page, Raphael Hau, Roger Bingham, Jonathan Mulford, Ian Incoll
Fractures of the distal radius are common and occur in all age groups. The incidence is high in older populations due to osteoporosis and increased falls risk. Considerable practice variation exists in the management of distal radius fractures in older patients ranging from closed reduction with cast immobilisation to open reduction with plate fixation. Plating is currently the most common surgical treatment. While there is evidence showing no significant advantage for some forms of surgical fixation over conservative treatment, and no difference between different surgical techniques, there is a lack of evidence comparing two of the most common treatments used: closed reduction and casting versus plating...
June 23, 2017: BMJ Open
https://www.readbyqxmd.com/read/28645890/tailored-communication-within-mobile-apps-for-diabetes-self-management-a-systematic-review
#13
Heidi Holmen, Astrid Klopstad Wahl, Milada Cvancarova Småstuen, Lis Ribu
BACKGROUND: The prevalence of diabetes is increasing and with the requirements for self-management and risk of late complications, it remains a challenge for the individual and society. Patients can benefit from support from health care personnel in their self-management, and the traditional communication between patients and health care personnel is changing. Smartphones and apps offer a unique platform for communication, but apps with integrated health care personnel communication based on patient data are yet to be investigated to provide evidence of possible effects...
June 23, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28644979/intraoperative-fast-ripples-independently-predict-postsurgical-epilepsy-outcome-comparison-with-other-electrocorticographic-phenomena
#14
Shaun A Hussain, Gary W Mathern, Phoebe Hung, Julius Weng, Raman Sankar, Joyce Y Wu
In the surgical management of epilepsy, the resection of cortex exhibiting interictal fast ripples (250-500Hz) on electrocorticography has been linked to postoperative seizure-freedom. Although fast ripples appear to accurately identify the epileptogenic zone-the minimum tissue that must be removed at surgery to achieve seizure-freedom-it has not been established that fast ripples are a superior biomarker in comparison with multimodal presurgical neuroimaging and other electrocorticography abnormalities. Hence, in the prediction of postoperative seizure-freedom, we compared the value of fast ripples with other intraoperative electocorticography abnormalities including focal slowing, paroxysmal fast activity, intermittent spike discharges, continuous epileptiform discharges, focal attenuation, and intraoperative seizures, as well as complete resection of the lesion defined by MRI and other neuroimaging...
June 16, 2017: Epilepsy Research
https://www.readbyqxmd.com/read/28644565/long-term-risk-of-infection-in-patients-with-crohn-s-disease-on-anti-tnf-treatment-a-prospective-single-center-cohort-study-in-china
#15
Yue Li, Hui Jun Shu, Hong Lu, Hong Yang, Ji Li, Bei Tan, Jiaming Qian
BACKGROUND: Anti-TNF agents have demonstrated to greatly improve management strategies for inflammatory bowel disease (IBD). Clinical trials and registry studies in Western countries have shown that infections and malignancy are the most concerned complications of anti-TNF treatment. However, data derived from clinical practice in China are limited. The aim of this study is to explore the long-term infection risk of infliximab (IFX) in treating patients with Crohn's disease (CD) from a tertiary IBD center in China...
June 23, 2017: Journal of Digestive Diseases
https://www.readbyqxmd.com/read/28643430/platinum-containing-regimens-for-metastatic-breast-cancer
#16
REVIEW
Sam J Egger, Melina L Willson, Jenna Morgan, Harriet S Walker, Sue Carrick, Davina Ghersi, Nicholas Wilcken
BACKGROUND: Studies have reported high tumour response rates for platinum-containing regimens in the treatment of women with metastatic breast cancer. Most of these studies were conducted prior to the 'intrinsic subtype' era, and did not specifically focus on metastatic triple-negative breast cancers (mTNBCs). OBJECTIVES: To identify and review the evidence from randomised trials comparing platinum-containing chemotherapy regimens with regimens not containing platinum in the management of women with metastatic breast cancer...
June 23, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28642559/little-evidence-to-support-or-refute-interventions-for-the-management-of-burning-mouth-syndrome
#17
Debra K Fischoff, Silvia Spivakovsky
Data sourcesCochrane Oral Health's Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), Medline Ovid, Embase Ovid, US National Institutes of Health Ongoing Trials Register (ClinicalTrials.gov) and the World Health Organization International Clinical Trials Registry Platform. Handsearch of the proceedings from the British Society for Oral Medicine (BSOM), British Society for Dental Research (BSDR) and the International Association for Dental Research (IADR).Study selectionAll included studies were randomised placebo controlled trials comparing a treatment to placebo with no language or year of publication restrictions...
June 23, 2017: Evidence-based Dentistry
https://www.readbyqxmd.com/read/28641999/effect-of-pharmacist-care-on-medication-adherence-and-cardiovascular-outcomes-among-patients-post-acute-coronary-syndrome-a%C3%A2-systematic-review
#18
REVIEW
Maguy Saffouh El Hajj, Myriam Jihad Jaam, Ahmed Awaisu
BACKGROUND: The impact of collaborative and multidisciplinary health care on the outcomes of care in patients with acute coronary syndromes (ACS) is well-established in the literature. However, there is lack of high quality evidence on the role of pharmacist care in this setting. OBJECTIVE: This systematic review aimed to evaluate the impact of pharmacist care on patient outcomes (readmission, mortality, emergency visits, and medication adherence) in patients with ACS at or post-discharge...
June 13, 2017: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/28641095/high-dose-chemotherapy-and-autologous-stem-cell-transplantation-in-relapsed-or-refractory-hodgkin-lymphoma-emerging-questions-newer-agents-and-changing-paradigm
#19
REVIEW
Saad Akhtar
Primary treatment for adult and pediatric patients with Hodgkin lymphoma (HL) using current multiagent anthracycline-based chemotherapy with or without radiation therapy will cure approximately >70% of the patients; >95% for early stage with a favorable risk profile and 70-75% with advanced stage and high risk features. Managing refractory and relapsed disease, however, remains a challenge. High dose chemotherapy (HDC) and autologous stem cell transplantation (auto-SCT) can salvage 40-70% of patients with relapsed or refractory HL...
June 13, 2017: Hematology/oncology and Stem Cell Therapy
https://www.readbyqxmd.com/read/28639183/proprotein-convertase-subtilisin-kexin-type-9-pcsk9-and-its-inhibitors-a-review-of-physiology-biology-and-clinical-data
#20
REVIEW
Ashwin Durairaj, Alberto Sabates, Jonathan Nieves, Brian Moraes, Seth Baum
Atherosclerotic cardiovascular disease (ASCVD) remains the number one killer in the western world. Low-density lipoprotein cholesterol (LDL-C) reduction with statins and ezetimibe has been shown to reduce the risk of cardiovascular events. Now, proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies (mabs) are available for high-risk individuals with ASCVD or familial hypercholesterolemia on maximally tolerated statin therapy but requiring greater LDL-C reduction. PCSK9 mab outcome trial results from the Further Cardiovascular Outcomes Research with PCSK9 Inhibitions in Subjects with Elevated Risk (FOURIER) study, which was presented at the American College of Cardiology in March 2017, which demonstrated a decrease of 15% in primary and 20% secondary end points over a 2-year period [1••]...
August 2017: Current Treatment Options in Cardiovascular Medicine
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