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Risk management in clinical trials

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https://www.readbyqxmd.com/read/28346238/management-of-hypertension-in-2017-targets-and-therapies
#1
Monica Ahluwalia, Sripal Bangalore
PURPOSE OF REVIEW: Approximately one-fourth of the adult population is diagnosed with hypertension, which has been associated with increased cardiovascular morbidity and mortality including cardiovascular death, myocardial infarction, heart failure and stroke. Early detection and treatment is a key and can lead to a significant reduction in cardiovascular morbidity and mortality. RECENT FINDINGS: In this review, we discuss the management and treatment strategies in patients with hypertension in the current era...
March 24, 2017: Current Opinion in Cardiology
https://www.readbyqxmd.com/read/28344807/ipilimumab-induced-thrombotic-thrombocytopenic-purpura-ttp
#2
Jeanelle King, Javier de la Cruz, Jose Lutzky
BACKGROUND: CTLA-4 (Cytotoxic T-lymphocyte-associated protein 4) was the first immune checkpoint receptor clinically targeted for use in cancer treatment. It is expressed exclusively on T-cells where its primary role is to regulate the amplitude of the early stages of T-cell activation.1 Ipilimumab, a CTLA-4 blocking antibody, has been widely used for the treatment of patients with high risk and metastatic melanoma. Given its mechanism of action and consequent immune activation, the side effect profile of this drug greatly differs from that of standard cytotoxic chemotherapy...
2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28343934/hitchhiker-s-guide-to-the-red-cell-storage-galaxy-omics-technologies-and-the-quality-issue
#3
REVIEW
Angelo D'Alessandro, Jerard Seghatchian
Red blood cell storage in the blood bank makes millions of units of available for transfusion to civilian and military recipients every year. From glass bottles to plastic bags, from anticoagulants to complex additives, from whole blood to leukocyte filtered packed red blood cells: huge strides have been made in the field of blood component processing and storage in the blood bank during the last century. Still, refrigerated preservation of packed red blood cells under blood bank conditions results in the progressive accumulation of a wide series of biochemical and morphological changes to the stored erythrocytes, collectively referred to as the storage lesion(s)...
March 9, 2017: Transfusion and Apheresis Science
https://www.readbyqxmd.com/read/28343733/low-risk-papillary-microcarcinoma-of-the-thyroid-a-review-of-active-surveillance-trials
#4
REVIEW
Y Ito, A Miyauchi, H Oda
Papillary microcarcinoma (PMC) of the thyroid is defined as papillary thyroid carcinoma (PTC) measuring ≤1 cm. Many autopsy studies on subjects who died of non-thyroidal diseases reported latent small thyroid carcinoma in up to 5.2% of the subjects. A mass screening study for thyroid cancer in Japanese adult women detected small thyroid cancer in 3.5% of the examinees. This incidence was close to the incidence of latent thyroid cancer and more than 1000 times the prevalence of clinical thyroid cancer in Japanese women reported at that time...
March 16, 2017: European Journal of Surgical Oncology
https://www.readbyqxmd.com/read/28343425/ppar-%C3%AE-agonists-are-still-on-the-rise-an-update-on-clinical-and-experimental-findings
#5
Nicola Ferri, Alberto Corsini, Cesare Sirtori, Massimiliano Ruscica
Non-fasting plasma triglyceride (TG) and remnant cholesterol levels, cholesterol content of triglyceride-rich lipoproteins, have been suggested to be an additional cause of cardiovascular diseases; thus, pharmacological TG-lowering with fibrates, activators of PPAR-alpha system, has been linked to risk reduction. Areas covered: This manuscript reviews available evidence on clinical trials involving highly selective PPAR-α agonists (i.e., pemafibrate) and drugs used in the pre-clinical and experimental setting (e...
March 27, 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28342811/myeloid-sarcoma-presentation-diagnosis-and-treatment
#6
REVIEW
L Max Almond, Maria Charalampakis, Samuel J Ford, David Gourevitch, Anant Desai
Myeloid sarcoma is an extramedullary tumor of immature granulocytic cells. It is a rare condition, most often associated with acute myeloid leukemia (AML), although in some rare cases it may present in nonleukemic patients. It should therefore be considered as a differential diagnosis of any atypical cellular infiltrate. It may occur at any site, leading to very varied clinical presentations. Diagnosis is challenging and relies on a high index of suspicion as well as radiology, histology, immunophenotyping, and molecular analyses, which also are essential for risk stratification and treatment planning...
March 7, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28342731/preferred-management-of-primary-deep-arm-vein-thrombosis
#7
REVIEW
F J Vazquez, P Paulin, D Poodts, E Gándara
OBJECTIVE: Given its rarity, the management of primary upper extremity deep vein thrombosis is controversial. Although anticoagulation alone is commonly advocated for its treatment, it is unclear if this will reduce the risk of developing post-thrombotic syndrome (PTS). The aim of this "Evidence Driven" Clinical Scenario is to evaluate whether more aggressive treatments (including catheter directed thrombolysis or surgery) might help reduce the risk of PTS or recurrent venous thromboembolism in patients with primary upper extremity deep vein thrombosis (DVT)...
March 22, 2017: European Journal of Vascular and Endovascular Surgery
https://www.readbyqxmd.com/read/28342609/randomized-blinded-controlled-clinical-trial-shows-no-benefit-of-homeopathic-mastitis-treatment-in-dairy-cows
#8
Fanny Ebert, Rudolf Staufenbiel, Julia Simons, Laura Pieper
Mastitis is one of the most common diseases in dairy production, and homeopathic remedies have been used increasingly in recent years to treat it. Clinical trials evaluating homeopathy have often been criticized for their inadequate scientific approach. The objective of this triple-blind, randomized controlled trial was to assess the efficacy of homeopathic treatment in bovine clinical mastitis. The study was conducted on a conventionally managed dairy farm between June 2013 and May 2014. Dairy cows with acute mastitis were randomly allocated to homeopathy (n = 70) or placebo (n = 92), for a total of 162 animals...
March 22, 2017: Journal of Dairy Science
https://www.readbyqxmd.com/read/28341473/pneumonia-after-cardiac-surgery-experience-of-the-national-institutes-of-health-canadian-institutes-of-health-research-cardiothoracic-surgical-trials-network
#9
Gorav Ailawadi, Helena L Chang, Patrick T O'Gara, Karen O'Sullivan, Y Joseph Woo, Joseph J DeRose, Michael K Parides, Vinod H Thourani, Sophie Robichaud, A Marc Gillinov, Wendy C Taddei-Peters, Marissa A Miller, Louis P Perrault, Robert L Smith, Lyn Goldsmith, Keith A Horvath, Kristen Doud, Kim Baio, Annetine C Gelijns, Alan J Moskowitz, Emilia Bagiella, John H Alexander, Alexander Iribarne
RATIONALE: Pneumonia remains the most common major infection after cardiac surgery despite numerous preventive measures. OBJECTIVES: To prospectively examine the timing, pathogens, and risk factors, including modifiable management practices, for postoperative pneumonia and estimate its impact on clinical outcomes. METHODS: A total of 5158 adult cardiac surgery patients were enrolled prospectively in a cohort study across 10 centers. All infections were adjudicated by an independent committee...
February 9, 2017: Journal of Thoracic and Cardiovascular Surgery
https://www.readbyqxmd.com/read/28339429/comparing-the-efficacy-of-surgery-and-medical-therapy-for-pain-management-in-endometriosis-a-systematic-review-and-meta-analysis
#10
Shahla Chaichian, Ali Kabir, Adolfazl Mehdizadehkashi, Khaled Rahmani, Mehrdad Moghimi, Bahram Moazzami
BACKGROUND: Pain is considered as one of the main symptoms of endometriosis. The treatment for endometriosis remains controversial. OBJECTIVES: The aim of this study is to compare the effect of medical or surgical treatments for pain-relief in patients with endometriosis. STUDY DESIGN: Systematic review and meta-analysis. SETTING: Published papers about evaluating pain treatment in endometriosis in PubMed, Scopus, and Google Scholar...
March 2017: Pain Physician
https://www.readbyqxmd.com/read/28338498/challenge-of-progressive-multiple-sclerosis-therapy
#11
Alan J Thompson
PURPOSE OF REVIEW: Understanding the mechanisms underlying progression in multiple sclerosis (MS) and identifying appropriate therapeutic targets is a key challenge facing the MS community. This challenge has been championed internationally by organizations such as the Progressive MS Alliance, which has raised the profile of progressive MS and identified the key obstacles to treatment. This review will outline the considerable progress against these challenges. RECENT FINDINGS: New insights into mechanisms underlying progression have opened up potential therapeutic opportunities...
March 23, 2017: Current Opinion in Neurology
https://www.readbyqxmd.com/read/28338025/preventing-perioperative-bleeding-in-patients-with-inherited-bleeding-disorders
#12
Colin Watterson, Nicholas Beacher
Data sourcesCochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, a regularly updated database informed by trials identified within electronic databases including MEDLINE. Further defined searches were undertaken in PubMed, Embase, The Cochrane Library, ClinicalTrials.gov and WHO International Clinical Trials Registry Platform. Additional hand searching of relevant journals and books of conference proceedings was undertaken.Study selectionRandomised and quasi-randomised controlled trials in people of all ages with haemophilia or VWD undergoing oral or dental procedures using antifibrinolytic agents (tranexamic acid (TXA) or epsilon aminocaproic acid (EACA)) to prevent perioperative bleeding compared to no intervention with or without placebo...
March 2017: Evidence-based Dentistry
https://www.readbyqxmd.com/read/28337750/efficacy-and-safety-of-the-drugs-used-to-reverse-direct-oral-anticoagulants-a-systematic-review-and-meta-analysis
#13
REVIEW
Luis Teodoro da Luz, Mylene Marchand, Bartolomeu Nascimento, Homer Tien, Avery Nathens, Prakesh Shah
BACKGROUND: Direct oral anticoagulants (DOACs) are effective and safe for prophylaxis and treatment of thromboembolic phenomena. However, managing DOACs during bleeding emergencies is challenging. A systematic review and meta-analysis was conducted on studies addressing efficacy and safety of the drugs used for reversal of DOACs. STUDY DESIGN AND METHODS: Medline, Embase, Cochrane Library, and ClinicalTrials.gov were searched up to September 2016. Studies that examined clinical and laboratory effects of drugs used to reverse DOACs were included...
March 24, 2017: Transfusion
https://www.readbyqxmd.com/read/28336985/the-hall-technique-10-years-on-its-effect-and-influence
#14
R R Welbury
Dental caries in early childhood can have a very significant effect not only on the oral health of young children but on their quality of life and that of their families. Added to this are the long-term infective risks to the host of untreated caries in primary teeth but also the risk of damage to successor permanent teeth. Traditional restoration of damaged primary teeth has been shown to have only moderate outcomes depending on the techniques and materials used and the ability of children to cooperate because of age or other factors...
March 24, 2017: British Dental Journal
https://www.readbyqxmd.com/read/28335690/promoting-physical-activity-after-stroke-via-self-management-a-feasibility-study
#15
Elisabeth Preston, Catherine M Dean, Louise Ada, Rosalyn Stanton, Sandy Brauer, Suzanne Kuys, Gordon Waddington
BACKGROUND: Many people with mild disability after stroke are physically inactive despite the risk of recurrent stroke. A self-management program may be one strategy to increase physical activity in stroke survivors. OBJECTIVES: To investigate the feasibility of a self-management program, and determine whether self-management can increase daily physical activity levels and self-efficacy for exercise, decrease cardiovascular risk, and improve walking ability, participation, and quality of life in people with mild disability after stroke...
March 23, 2017: Topics in Stroke Rehabilitation
https://www.readbyqxmd.com/read/28334433/dietary-interventions-for-recurrent-abdominal-pain-in-childhood
#16
REVIEW
Tamsin V Newlove-Delgado, Alice E Martin, Rebecca A Abbott, Alison Bethel, Joanna Thompson-Coon, Rebecca Whear, Stuart Logan
BACKGROUND: This is an update of the original Cochrane review, last published in 2009 (Huertas-Ceballos 2009). Recurrent abdominal pain (RAP), including children with irritable bowel syndrome, is a common problem affecting between 4% and 25% of school-aged children. For the majority of such children, no organic cause for their pain can be found on physical examination or investigation. Many dietary inventions have been suggested to improve the symptoms of RAP. These may involve either excluding ingredients from the diet or adding supplements such as fibre or probiotics...
March 23, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28334427/capnography-versus-standard-monitoring-for-emergency-department-procedural-sedation-and-analgesia
#17
REVIEW
Brian F Wall, Kirk Magee, Samuel G Campbell, Peter J Zed
BACKGROUND: Procedural sedation and analgesia (PSA) is used frequently in the emergency department (ED) to facilitate painful procedures and interventions. Capnography, a monitoring modality widely used in operating room and endoscopy suite settings, is being used more frequently in the ED setting with the goal of reducing cardiopulmonary adverse events. As opposed to settings outside the ED, there is currently no consensus on whether the addition of capnography to standard monitoring modalities reduces adverse events in the ED setting...
March 23, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28332871/sodium-glucose-cotransporter-2-and-dipeptidyl-peptidase-4-inhibition-promise-of-a-dynamic-duo
#18
Ildiko Lingvay
OBJECTIVE: This article reviews evidence supporting sodium glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP-4) inhibitor combination therapy for management of type 2 diabetes mellitus (T2DM). METHODS: We conducted a non-systematic review of the literature focusing on single-pill or fixed-dose combinations of SGLT2 inhibitors and DPP-4 inhibitors available in the United States. RESULTS: SGLT2 inhibitors and DPP-4 inhibitors have complementary mechanisms of action that address several of the underlying pathophysiological abnormalities present in T2DM without overlapping toxicities...
March 23, 2017: Endocrine Practice
https://www.readbyqxmd.com/read/28331624/comparison-of-hydroxyethyl-starch-regulatory-summaries-from-the-food-and-drug-administration-and-the-european-medicines-agency
#19
Christian J Wiedermann, Klaus Eisendle
This article aims to highlight the positions of the Food and Drug Administration and the European Medicines Agency regarding use and marketing of hydroxyethyl starch (HES) products, and how these have changed over recent years. In 2013, warnings from both agencies advised against use of HES in critically ill patients, including patients with sepsis, when several large randomized controlled trials on volume resuscitation in critical illness failed to observe clinically beneficial effects of HES. In areas such as patient monitoring and requirements for further clinical trials, the FDA and EMA are very much in agreement in their recommendations...
2017: Journal of Pharmaceutical Policy and Practice
https://www.readbyqxmd.com/read/28330818/cardio-onco-hematology-in-clinical-practice-position-paper-and-recommendations
#20
Teresa López-Fernández, Ana Martín García, Ana Santaballa Beltrán, Ángel Montero Luis, Ramón García Sanz, Pilar Mazón Ramos, Sonia Velasco Del Castillo, Esteban López de Sá Areses, Manuel Barreiro-Pérez, Rocío Hinojar Baydes, Leopoldo Pérez de Isla, Silvia Cayetana Valbuena López, Regina Dalmau González-Gallarza, Francisco Calvo-Iglesias, Juan José González Ferrer, Antonio Castro Fernández, Eva González-Caballero, Cristina Mitroi, Meritxell Arenas, Juan Antonio Virizuela Echaburu, Pascual Marco Vera, Andrés Íñiguez Romo, José Luis Zamorano, Juan Carlos Plana Gómez, José Luis López Sendón Henchel
Improvements in early detection and treatment have markedly reduced cancer-related mortality. However survival not only depends on effectively cure cancer, but prevention, diagnosis and treatment of cancer-related complications is also needed. Cardiovascular toxicity is a widespread problem across many classes of therapeutic schemes, however scientific evidence in the management of cardiovascular complications of onco-hematological patients is scarce, as these patients have been systematically excluded from clinical trials and current recommendations are based on expert consensus...
March 18, 2017: Revista Española de Cardiología
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