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Risk management in clinical trials

Paolo Girardi, Roberto Brugnoli, Giovanni Manfredi, Gabriele Sani
Lithium has been a gold standard in the treatment of bipolar disorder (BD) for several decades. Despite a general reduction in the use of lithium over the past several years, it is effective in the management of both manic and depressive episodes in BD and continues to be recommended as a first-line mood stabilizer. This review provides an overview of the pharmacology of lithium and highlights its clinical profile in the management of BD, focusing on the potential advantages of prolonged-release (PR) versus immediate-release (IR) formulations of lithium...
October 21, 2016: Drugs in R&D
Mahnaz Ashoorkhani, Ali Bozorgi, Reza Majdzadeh, Hamed Hosseini, Ali Yoonessi, Ali Ramezankhani, Hassan Eftekhar
BACKGROUND: Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment...
October 21, 2016: Trials
David E Rosow, Jamal Ahmed
Importance: Adult laryngotracheal stenosis (LTS) is typically managed surgically, but some patients fail treatment because of rapid restenosis or granulation tissue formation. The need for frequent surgery or tracheostomy reduces the quality of life in these patients and poses a significant challenge for the treating physician. New adjuvant treatments are required to reduce the surgical burden of this condition. Objective: To examine whether patients with rapidly recurrent nonvasculitic LTS who fail surgical management of their stenosis (ie, requiring dilation more frequently than every 6 months) experience longer intervals between surgical procedures when receiving adjuvant treatment with low-dose methotrexate...
October 20, 2016: JAMA Otolaryngology—Head & Neck Surgery
Anne M Murray, Fang-Chi Hsu, Jeff D Williamson, R Nick Bryan, Hertzel C Gerstein, Mark D Sullivan, Michael E Miller, Iris Leng, Laura L Lovato, Lenore J Launer
AIMS/HYPOTHESIS: The Memory in Diabetes (MIND) substudy of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, a double 2x2 factorial parallel-group randomised clinical trial, tested whether intensive compared with standard management of hyperglycaemia, BP or lipid levels reduced cognitive decline and brain atrophy in 2977 people with type 2 diabetes. We describe the results of the observational extension study, ACCORDION MIND ( registration no. NCT00182910), which aimed to measure the long-term effects of the three ACCORD interventions on cognitive and brain structure outcomes approximately 4 years after the trial ended...
October 20, 2016: Diabetologia
Lyndon G Amorin-Woods, Gregory F Parkin-Smith, Lee Nedkoff, Colleen Fisher
BACKGROUND: This paper reports the quantitative outcomes of a mixed-methods pilot study of the characteristics and demographics of chiropractic practices and patients in Western Australia. METHODS: This was a mixed-methods data transformation model (qualitative to quantitative) pilot study. A non-random sample of chiropractic practices across Western Australia was recruited and data collected anonymously from consecutive new patients using an online platform. Data covered practice and patient demographics and characteristics, alongside quality of life measures...
2016: Chiropractic & Manual Therapies
José L de Brito Alves, Vanessa P de Sousa, Marinaldo P Cavalcanti Neto, Marciane Magnani, Valdir de Andrade Braga, João H da Costa-Silva, Carol G Leandro, Hubert Vidal, Luciano Pirola
Arterial hypertension (AH) is one of the most prevalent risk factors for cardiovascular diseases (CD) and is the main cause of deaths worldwide. Current research establish that dietary polyphenols may help to lower blood pressure (BP), thus contributing to the reduction of cardiovascular complications. In addition, the health benefits of probiotics on BP have also attracted increased attention, as probiotics administration modulates the microbiota, which, by interacting with ingested polyphenols, controls their bioavalability...
2016: Frontiers in Physiology
T A Tomsick, J Carrozzella, L Foster, M D Hill, R von Kummer, M Goyal, A M Demchuk, P Khatri, Y Palesch, J P Broderick, S D Yeatts, D S Liebeskind
BACKGROUND AND PURPOSE: Uncertainty persists regarding the safety and efficacy of endovascular therapy of M2 occlusions following IV tPA. We reviewed the impact of revascularization on clinical outcomes in 83 patients with M2 occlusions in the Interventional Management of Stroke III trial according to specific M1-M2 segment anatomic features. MATERIALS AND METHODS: Perfusion of any M2 branch distinguished M2-versus-M1 occlusion. Prespecified modified TICI and arterial occlusive lesion revascularization and clinical mRS 0-2 end points at 90 days for endovascular therapy-treated M2 occlusions were analyzed...
October 20, 2016: AJNR. American Journal of Neuroradiology
Elisa Bruno, Alessandra Nicoletti, Graziella Quattrocchi, Graziella Filippini, Carlo Colosimo, Mario Zappia
BACKGROUND: Essential tremor is one of the most common movement disorders. Treatment primarily consists of pharmacological agents. While primidone and propranolol are well-established treatments in clinical practice, they may be ineffective in 25% to 55% of patients and can produce serious adverse events in a large percentage of them. For these reasons, it is worth evaluating the treatment alternatives for essential tremor. Some specialists have suggested that pregabalin could be a potentially useful agent, but there is uncertainty about its efficacy and safety...
October 20, 2016: Cochrane Database of Systematic Reviews
Ashok Buchiboyina, Bonny Jasani, Mangesh Deshmukh, Sanjay Patole
OBJECTIVE: To conduct a systematic review of strategies for the management of transient tachypnoea of the newborn (TTN). METHODS: The Cochrane Collaboration and PRISMA guidelines were used for conducting and reporting this systematic review, respectively. The Cochrane Central Register of Controlled Trials, PubMed, CINAHL and EMBASE databases were searched in February 2016. Only randomised and quasi-randomised controlled trials (RCTs) assessing any intervention for the management of TTN in infants <7 days of age, born at 35 or more weeks with a clinical diagnosis of TTN were eligible for inclusion...
October 20, 2016: Journal of Maternal-fetal & Neonatal Medicine
Geerte C Den Hollander, Joyce L Browne, Daniel Arhinful, Rieke van der Graaf, Kerstin Klipstein-Grobusch
To address the burden of maternal morbidity and mortality in low- and middle-income countries (LMICs), research with pregnant women in these settings is increasingly common. Pregnant women in LMIC-context may experience vulnerability related to giving consent to participate in a clinical trial. To recognize possible layers of vulnerability this study aims to identify factors that influence the decision process towards clinical trial participation of pregnant women in an urban middle-income setting. This qualitative research used participant observation, in-depth interviews, and focus group discussion with medical staff and pregnant women eligible for trial participation, at a regional hospital in Accra, Ghana...
October 20, 2016: Developing World Bioethics
Michael B Boffa
PURPOSE OF REVIEW: Elevated plasma concentrations of lipoprotein(a) (Lp(a)) are an independent and causal risk factor for cardiovascular diseases including coronary artery disease, ischemic stroke, and calcific aortic valve stenosis. This review summarizes the rationale for Lp(a) lowering and surveys relevant clinical trial data using a variety of agents capable of lowering Lp(a). RECENT FINDINGS: Contemporary guidelines and recommendations outline populations of patients who should be screened for elevated Lp(a) and who might benefit from Lp(a) lowering...
December 2016: Current Atherosclerosis Reports
Michael Kongnyuy, Daniel M Halpern, Kaitlin E Kosinski, Aaron E Katz
PURPOSE: We aim to evaluate the current beliefs and practice patterns of urologists in regard to use of cryosurgery for management of PCa. METHODS: An anonymous 13-point survey was designed and sent out to members of the Society of Urologic Oncology (SUO), Endourological Society (ES) and American College of Cryosurgery (ACC). Descriptive statistics and univariate analyses were used to determine variables associated with the use of cryosurgery. RESULTS: Of the 206 responses received [81 (39...
October 19, 2016: International Urology and Nephrology
Michele Carron
Non-invasive ventilation (NIV) has assumed an important role in the management of acute respiratory failure (ARF). NIV, compared with standard medical therapy, improves survival and reduces complications in selected patients with ARF. NIV represents the first-line intervention for some forms of ARF, such as chronic obstructive pulmonary disease (COPD) exacerbations and acute cardiogenic pulmonary edema. The use of NIV is also well supported for immunocompromised patients who are at high risk for infectious complications from endotracheal intubation...
September 2016: Annals of Translational Medicine
Marius N Stan, Mario Salvi
Rituximab (RTX) use in open label series has been associated with very encouraging responses in patients with active and moderate-to-severe Graves' Orbitopathy (GO). Recently randomized controlled trials of RTX have been performed in such patients in order to answer the question of clinical efficacy and the safety profile of this agent. That data, reported separately, focused on Clinical Activity Score (CAS) and indicated in one trial a strong benefit of RTX in comparison with IV glucocorticoids while the other trial noted the absence of a benefit by comparison with placebo...
October 19, 2016: European Journal of Endocrinology
Daniel W Birch, Jerry T Dang, Noah J Switzer, Namdar Manouchehri, Xinzhe Shi, Ghassan Hadi, Shahzeer Karmali
BACKGROUND: Intraoperative hypothermia during both open and laparoscopic abdominal surgery may be associated with adverse events. For laparoscopic abdominal surgery, the use of heated insufflation systems for establishing pneumoperitoneum has been described to prevent hypothermia. Humidification of the insufflated gas is also possible. Past studies on heated insufflation have shown inconclusive results with regards to maintenance of core temperature and reduction of postoperative pain and recovery times...
October 19, 2016: Cochrane Database of Systematic Reviews
Xuesong Han, Ahmedin Jemal, Erin Hulland, Edgar P Simard, Loretta Nastoupil, Elizabeth M Ward, Christopher R Flowers
BACKGROUND: Highly active antiretroviral therapy (HAART) has extended the life expectancy of HIV/AIDS patients to approach that of the general population. However, it remains unclear whether HIV infection affects the survival of lymphoma patients in the HAART era. METHODS: Patients diagnosed with Hodgkin lymphoma (HL), diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), peripheral T-cell lymphoma (PTCL) or follicular lymphoma (FL) during 2004-2011 were identified from the National Cancer Database...
October 18, 2016: Cancer Epidemiology, Biomarkers & Prevention
Chun-Yuan Lee, Calvin M Kunin, Chung Chang, Susan Shin-Jung Lee, Yao-Shen Chen, Hung-Chin Tsai
BACKGROUND: Cellulitis is a common infectious disease. Although blood culture is frequently used in the diagnosis and subsequent treatment of cellulitis, it is a contentious diagnostic test. To help clinicians determine which patients should undergo blood culture for the management of cellulitis, a diagnostic scoring system referred to as the Bacteremia Score of Cellulitis was developed. METHODS: Univariable and multivariable logistic regression analyses were performed as part of a retrospective cohort study of all adults diagnosed with cellulitis in a tertiary teaching hospital in Taiwan in 2013...
October 19, 2016: BMC Infectious Diseases
Susmita Chatterjee, Anupam Sarkar, Krishna D Rao
BACKGROUND: Postpartum heammorrhage (PPH), defined as blood loss greater than or equal to 500 ml within 24 hours after birth, is the leading cause of maternal deaths globally and in India. Misoprostol is an important option for PPH management in setting where oxytocin (the gold standard for PPH prevention and treatment) in not available or not feasible to use. For the substantial number of deliveries which take place at home or at lower level heatlh facilities in India, misoprostol pills can be adminstered to prevent PPH...
2016: PloS One
Rosemary Townsend, Asma Khalil
PURPOSE OF REVIEW: Selective intrauterine growth restriction (sIUGR) in twin pregnancies presents a complex management problem for the fetal medicine specialist. This review summarizes what is currently known about sIUGR pathophysiology, particularly in monochorionic pregnancies and looks at the results of early trials of fetal intervention in high-risk sIUGR pregnancies. RECENT FINDINGS: sIUGR in monochorionic pregnancies is due to unequal placental sharing, but the clinical outcome is determined by the characteristics of the placental vascular anastomoses...
October 15, 2016: Current Opinion in Obstetrics & Gynecology
Michael J Murray, Heidi DeBlock, Brian Erstad, Anthony Gray, Judi Jacobi, Che Jordan, William McGee, Claire McManus, Maureen Meade, Sean Nix, Andrew Patterson, M Karen Sands, Richard Pino, Ann Tescher, Richard Arbour, Bram Rochwerg, Catherine Friederich Murray, Sangeeta Mehta
OBJECTIVE: To update the 2002 version of "Clinical practice guidelines for sustained neuromuscular blockade in the adult critically ill patient." DESIGN: A Task Force comprising 17 members of the Society of Critical Medicine with particular expertise in the use of neuromuscular-blocking agents; a Grading of Recommendations Assessment, Development, and Evaluation expert; and a medical writer met via teleconference and three face-to-face meetings and communicated via e-mail to examine the evidence and develop these practice guidelines...
November 2016: Critical Care Medicine
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