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fact trial

Andrew B Schenkel, Ivy Peltz, Analia Veitz-Keenan
BACKGROUND: Resin-based composite (RBC) is currently accepted as a viable material for the restoration of caries for posterior permanent teeth requiring surgical treatment. Despite the fact that the thermal conductivity of the RBC restorative material closely approximates that of natural tooth structure, postoperative hypersensitivity is sometimes still an issue. Dental cavity liners have historically been used to protect the pulp from the toxic effects of some dental restorative materials and to prevent the pain of thermal conductivity by placing an insulating layer between restorative material and the remaining tooth structure...
October 25, 2016: Cochrane Database of Systematic Reviews
Claudia Riedel, Birka Lehmann, Karl Broich, Thomas Sudhop
In Germany and throughout Europe, medicinal products for adults have been developed and evaluated systematically for decades. Medicinal products for children and adolescents, however, have only been researched for the past ten years. As a result, many medicinal products have been administered to children without systematic clinical trials, for example regarding dosage or pharmaceutical form.EU Regulation 1901/2006 aimes to close the gaps in the medical treatment of children and adolescents. In order to do so, the regulation provides for paediatric use marketing authorisations (PUMA) for previously authorised products no longer covered by intellectual property rights and also grants holders of such PUMA licenses further property rights...
October 24, 2016: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Richard G Ohye, Dietmar Schranz, Yves D'Udekem
Universally fatal only 4 decades ago, the progress in the 3-stage palliation of hypoplastic left heart syndrome and related single right ventricular lesions has drastically improved the outlook for these patients. Although the stage II operation (hemi-Fontan or bidirectional Glenn) and stage III Fontan procedure have evolved into relatively low-risk operations, the stage I Norwood procedure remains one of the highest-risk and costliest common operations performed in congenital heart surgery. Yet, despite this fact, experienced centers now report hospital survivals of >90% for the Norwood procedure...
October 25, 2016: Circulation
Aiko Tanaka, Mie Nishimura, Yuji Sato, Hiroki Sato, Jun Nishihira
Pleurotus cornucopiae (Oyster mushroom, Tamogitake) has long been eaten as a functional food for enhancement of the immune system, but its effectiveness has not been well confirmed in humans. To this end, we set up a double-blind placebo-controlled human clinical trial to investigate the potential of Oyster mushrooms with respect to the up-regulation of the immune system. The subjects ingested Oyster mushroom extract for 8 weeks. We measured the serum cytokine levels involved in regulation of the immune system, including interferon (IFN)-γ, interleukin (IL)-4, IL-5, IL-10, IL-12, IL-13, and tumor-necrosis factor (TNF)-α...
October 2016: Journal of Traditional and Complementary Medicine
John Slattery, Derrick F MacFabe, Richard E Frye
Recent studies have highlighted the fact that the enteric microbiome, the trillions of microbes that inhabit the human digestive tract, has a significant effect on health and disease. Methods for manipulating the enteric microbiome, particularly through probiotics and microbial ecosystem transplantation, have undergone some study in clinical trials. We review some of the evidence for microbiome alteration in relation to childhood disease and discuss the clinical trials that have examined the manipulation of the microbiome in an effort to prevent or treat childhood disease with a primary focus on probiotics, prebiotics, and/or synbiotics (ie, probiotics + prebiotics)...
2016: Clinical Medicine Insights. Pediatrics
Francis Barchi, Madison T Little
BACKGROUND: Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. METHODS: An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country...
October 22, 2016: BMC Medical Ethics
Charles Kaboré, Valéry Ridde, Séni Kouanda, Ludovic Queuille, Paul-André Somé, Isabelle Agier, Alexandre Dumont
BACKGROUND: Since 2006, Burkina Faso has subsidized the cost of caesarean sections to increase their accessibility. Caesareans are performed by obstetricians, general practitioners, and nurses trained in emergency surgery. While the national caesarean rate is still too low (only 2 % in 2010), 12 to 24 % of caesareans performed in hospital are, in fact, not medically indicated. The objective of this study is to evaluate the effectiveness and analyze the implementation of a multi-faceted intervention to lower the rate of non-medically indicated caesareans in Burkina Faso...
October 21, 2016: BMC Pregnancy and Childbirth
Stefano Salciccia, Alessandro Gentilucci, Susanna Cattarino, Alessandro Sciarra
On the basis of the trials available, are we ready to consider GnRH antagonists better than agonists? Is there a population of patients who may benefit from antagonists more than agonists?We specifically focused our analysis on the significance of oncological results obtained in phase III trials directly comparing Degarelix with GnRH agonists. Oncological results were evaluated only in 1 trial (CS21) with some subanalysis and they were not the primary endpoints of the study. The follow-up duration was 364 days, and therefore, the number of events (all causes deaths and prostate cancer (PC), Prostate Specific Antigen (PSA), Hazard ratio (HR)-related deaths) was very low in both groups and this aspect strongly reduces the significance of overall survival evaluation...
October 15, 2016: Urologia
Koji Kono, Wei-Peng Yong, Hirokazu Okayama, Asim Shabbir, Tomoyuki Momma, Shinji Ohki, Seiichi Takenoshita, Jimmy So
Among advanced gastric cancer cases, peritoneal dissemination is a life-threatening mode of metastasis, and any strategy to control peritoneal metastasis will significantly improve treatment outcomes. Since intraperitoneal administration of anticancer drugs can induce an extremely high concentration of drugs in the peritoneal cavity, intraperitoneal chemotherapy would appear to be a reasonable and promising strategy to control the peritoneal dissemination. However, it has been reported in the past that intraperitoneal administration of mitomycin C or cisplatin resulted in no significant clinical effects against peritoneal metastasis of gastric cancer...
October 20, 2016: Gastric Cancer
Sarah V Stevenage, Christy Pitfield
The data described here provide standard performance measures following administration of a fingerprint matching task to expert analysts, trained students and novice control participants. Measures include accuracy on 'same' and 'different' trials, and the associated measures of sensitivity of discrimination (d') and response bias (C). In addition, speed of correct response is provided. The provision of these data will enable the interested reader to conduct meta-analyses relating to questions of fingerprint expertise and fingerprint training (see "Fact or friction: examination of the transparency, reliability and sufficiency of the ACE-V method of fingerprint analysis" (Stevenage and Pitfield, in press) [1])...
December 2016: Data in Brief
Matthew Thomas Sims, Zachary Carter Sanchez, James Murphy Herrington, James Barrett Hensel, Nolan Michael Henning, Caleb Josiah Scheckel, Matt Vassar
INTRODUCTION: With the intent of improving transparency in clinical research, the International Committee of Medical Journal Editors (ICMJE) established guidelines in 2005 regarding prospective clinical trial registration. This action worked to address bias related to selective outcome reporting in the medical literature. The objective of this study was to assess and characterize the quality of registration of clinical trials appearing in shoulder arthroplasty-related medical journals...
2016: PloS One
Zhaleh Shariati Sarabi, Mehran Ghazi Saeidi, Mandana Khodashahi, Ali Etemad Rezaie, Kamila Hashemzadeh, Rozita Khodashahi, Hossein Heidari
BACKGROUND: Rheumatoid arthritis (RA) is a chronic inflammatory joint disorder with unknown etiology. Atorvastatin is a lipid-lowering agent that affects the inflammatory processes. OBJECTIVE: This study aimed to determine the anti-inflammatory effects of atorvastatin on the Disease Activity Index and high-density lipoprotein (HDL) concentrations in RA patients. METHODS: This clinical trial was performed on 38 RA patients, who were referred to the Imam Reza and Ghaem Medical Centers of Mashhad, Iran between 2013 and 2014...
August 2016: Electronic Physician
Mark S Corbett, Judith Watson, Alison Eastwood
BACKGROUND: We recently published a systematic review of different healthcare settings (such as outpatient, community or home) for administering intravenous chemotherapy, and concluded that performing conventionally designed randomised trials was difficult. The main problems were achieving adequate trial accrual rates and recruiting a study population which adequately represented the target population of interest. These issues stemmed from the fact that potential participants may have had pre-trial perceptions about the trial settings they may be allocated; such preferences will sometimes be strong enough for patients to decline an invitation to participate in a trial...
October 19, 2016: BMC Health Services Research
Landhing M Moran, Karran A Phillips, William J Kowalczyk, Udi E Ghitza, Daniel A Agage, David H Epstein, Kenzie L Preston
Aripiprazole blocks psychostimulant seeking in a rat model of relapse. However, in humans, it may increase ongoing use. We tested aripiprazole specifically for relapse prevention. Methadone-maintained outpatients who were abstinent from cocaine in weeks 11-12 were randomized to double-blind aripiprazole (15 mg daily) or placebo in weeks 13-27 after 12 weeks of contingency management. Participants reported craving through ecological momentary. We stopped the trial because very few (18/41) participants fulfilled the abstinence criterion...
October 14, 2016: Behavioural Pharmacology
Allan S Jaffe, Harvey D White
High sensitivity cardiac troponin (hscTn) assays are used everywhere except in the United States.(1) One potential advantage of these assays is the ability to triage patients with possible ischemia more rapidly and, there is an understandable desire to find easy, facile algorithms to do this. This was the approach taken with hscTn in the evaluation of patients with possible acute myocardial infarction (AMI) using an algorithm developed by the Advantageous Predictors of Acute Coronary Syndromes Evaluation (APACE) trial...
October 17, 2016: Circulation
Clive Rosendorff
Many guidelines for the management of hypertension have recommended that the goal of antihypertensive treatment in the elderly (usually specified as 80 years or above) should be less than 150/90 mmHg. SPRINT included subjects 50 years or above, and a substantial proportion of subjects 75 years and older. These are individuals at high risk for adverse cardiovascular events because of high prevalence of hypertension and atherosclerotic disease. The less stringent BP goals have been based on a percieved danger of lowering BP to levels that threaten vital organ pefusion (myocardium, brain, kidney)...
September 2016: Journal of Hypertension
Sverre Kjeldsen
There is a whole armament of good drugs for treatment of hypertension including diuretics, calcium antagonist, angiotensin receptor antagonists and angiotensin converting enzyme inhibitors. Secondary drugs mostly used for special indications include beta-blockers, alpha-blockers, mineralocorticoid receptor antagonists (aldosterone antagonists), renin-inhibitors, centrally acting drugs, direct vasodilators and others.A variety of new drugs targeting different pressor mechanism exist and have partly been studies experimentally but will unlikely make it to clinical use in human hypertension...
September 2016: Journal of Hypertension
Kazuyuki Shimada
Stroke is known to frequently recur in patients with a history of cerebrovascular disease, and the control of hypertension is extremely important for the treatment of those patients. The robust relationship between the recurrent cerebrovascular disease and blood pressure control has been demonstrated in large-scale clinical studies. The antihypertensive drug therapy significantly reduces the recurrence rate of all types of cerebrovascular disease, incidences of myocardial infarction and all vascular events...
September 2016: Journal of Hypertension
Edward Tuddenham
The declarative title is a fair summary of research described in this paper (Targeting Factor VIII expression to platelets for hemophilia A gene therapy does not induce an apparent thrombotic risk in mice)(10) , is a fair summary of research described in this paper, which is itself the 14th in a series from the group of researchers led by Montgomery who, since 2003 have progressively advanced the idea of storing factor VIII in platelets to treat hemophilia A. Why, one might ask, would one do such a thing when evolution has selected endothelial cells as both the site for synthesis and release of factor VIII complexed with Von Willebrand factor to provide the cofactor when and where needed?(1,2) The answer lies in the unfortunate fact that a high proportion of patients with hemophilia develop resistance to factor VIII due to alloimmunity to the protein, which is foreign to their immune system, leading to production of inhibitory antibodies to the cofactor...
October 17, 2016: Journal of Thrombosis and Haemostasis: JTH
Massimiliano Alessandrini, Federica Gaiotti, Nicola Belfiore, Fabiola Matarese, Claudio D'Onofrio, Diego Tomasi
BACKGROUND: Environmental factors have been acknowledged as greatly influencing grape and wine aromas. Among them, the effect of altitude on grape aroma compounds has been scarcely debated in literature, to date. In this study, we investigated the influence of altitude on grape composition and aroma evolution during ripening of Vitis vinifera L. cultivar Glera grown in Conegliano-Valdobbiadene DOCG area (Italy). RESULTS: The site at highest altitude (380 m above sea level) was warmer than the lowest one (200 m a...
October 16, 2016: Journal of the Science of Food and Agriculture
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