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1.  Toward the development of a cortically based visual neuroprosthesis 
Journal of neural engineering  2009;6(3):035001.
Motivated by the success of cochlear implants for deaf patients, we are now facing the goal of creating a visual neuroprosthesis designed to interface with the occipital cortex as a means through which a limited but useful sense of vision could be restored in profoundly blind patients. We review the most important challenges regarding this neuroprosthetic approach and emphasize the need for basic human psychophysical research on the best way of presenting complex stimulating patterns through multiple microelectrodes. Continued research will hopefully lead to the development of and design specifications for the first generation of a cortically based visual prosthesis system.
doi:10.1088/1741-2560/6/3/035001
PMCID: PMC2941645  PMID: 19458403
2.  Humans ignore motion and stereo cues in favour of a fictional stable world 
Current biology : CB  2006;16(4):428-432.
Summary
As a human observer moves through the world, their eyes acquire a changing sequence of images. The information from this sequence is sufficient to determine the structure of a 3-D scene, up to a scale factor determined by the distance that the eyes have moved [1, 2]. There is good evidence that the human visual system accounts for the distance the observer has walked [3, 4] and the separation of the eyes [5-8] when judging the scale, shape and distance of objects. However, using an immersive virtual reality environment we created a scene that provided consistent information about scale from both distance walked and binocular vision and yet observers failed to notice when this scene expanded or contracted. This failure led to large errors in judging the size of objects. The pattern of errors cannot be explained by assuming a visual reconstruction of the scene with an incorrect estimate of interocular separation or distance walked. Instead, it is consistent with a Bayesian model of cue integration in which the efficacy of motion and disparity cues is greater at near viewing distances. Our results imply that observers are more willing to adjust their estimate of interocular separation or distance walked than to accept that the scene has changed in size.
doi:10.1016/j.cub.2006.01.019
PMCID: PMC2833396  PMID: 16488879
3.  Asymptomatic neurocognitive disorders in patients infected by HIV: fact or fiction? 
BMC Medicine  2011;9:138.
Neurocognitive disorders are emerging as a possible complication in patients infected with HIV. Even if asymptomatic, neurocognitive abnormalities are frequently detected using a battery of tests. This supported the creation of asymptomatic neurocognitive impairment (ANI) as a new entity. In a recent article published in BMC Infectious Diseases, Magnus Gisslén and colleagues applied a statistical approach, concluding that there is an overestimation of the actual problem. In fact, about 20% of patients are classified as neurocognitively impaired without a clear impact on daily activities. In the present commentary, we discuss the clinical implications of their findings. Although a cautious approach would indicate a stricter follow-up of patients affected by this disorder, it is premature to consider it as a proper disease. Based on a review of the data in the current literature we conclude that it is urgent to conduct more studies to estimate the overall risk of progression of the asymptomatic neurocognitive impairment. Moreover, it is important to understand whether new biomarkers or neuroimaging tools can help to identify better the most at risk population.
Please see related article: http://www.biomedcentral.com/1471-2334/11/356
doi:10.1186/1741-7015-9-138
PMCID: PMC3273440  PMID: 22204606
HIV; asymptomatic neurocognitive impairment; HIV dementia; HAART
4.  Immunomodulatory Effects of Adipose-Derived Stem Cells: Fact or Fiction? 
BioMed Research International  2013;2013:383685.
Adipose-derived stromal cells (ASCs) are often referred to as adipose-derived stem cells due to their potential to undergo multilineage differentiation. Their promising role in tissue engineering and ability to modulate the immune system are the focus of extensive research. A number of clinical trials using ASCs are currently underway to better understand the role of such cell niche in enhancing or suppressing the immune response. If governable, such immunoregulatory role would find application in several conditions in which an immune response is present (i.e., autoimmune conditions) or feared (i.e., solid organ or reconstructive transplantation). Although allogeneic ASCs have been shown to prevent acute GvHD in both preclinical and clinical studies, their potential warrants further investigation. Well-designed and standardized clinical trials are necessary to prove the role of ASCs in the treatment of immune disorders or prevention of tissue rejection. In this paper we analyze the current literature on the role of ASCs in immunomodulation in vitro and in vivo and discuss their potential in regulating the immune system in the context of transplantation.
doi:10.1155/2013/383685
PMCID: PMC3782761  PMID: 24106704
5.  Food allergy--fact or fiction: a review. 
Food sensitivity is a common condition presenting with various clinical syndromes including migraine, urticaria, gluten enteropathy, Crohn's disease and irritable bowel syndrome. It is a heterogeneous condition affecting different organ systems and is also aetiologically diverse with subgroups due to allergy, pharmacological reactions, enzyme deficiencies and psychological causes. Clinical acceptance of food sensitivity has been delayed by the use of dubious diagnostic techniques by a minority of practitioners and the lack of laboratory diagnostic tests, but several double blind studies have now fully validated the existence of food sensitivity syndromes. More widespread recognition of food sensitivity would be cost effective for the National Health Service.
PMCID: PMC1293647  PMID: 1433127
6.  L'homéopathie: fiction ou réalité? Définition et recherches cliniques 
Canadian Family Physician  1990;36:141-181.
Interest in alternative medicine is increasing. Family physicians, frequently asked by patients about the merits of these practices, must increase their knowledge in order to develop an enlightened, scientific approach to the subject. Homeopathy is one such system of medicine; it was founded by Dr. Samuel Hahnemann nearly 200 years ago. Clinical research in homeopathy is in the very early stages. To date, clinical trials to determine the efficacy of individual homeopathic remedies and the validity of homeopathic theory generally have been inconclusive. It is to be hoped that clinical research in homeopathy will continue so that we can increase our knowledge and provide our patients with better answers to their questions.
PMCID: PMC2280334  PMID: 21249117
7.  Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial 
Trials  2012;13:94.
Background
Optic neuritis is a frequent manifestation of multiple sclerosis. Visual deficits range from a minor impairment of visual functions through to complete loss of vision. Although many patients recover almost completely, roughly 35% of patients remain visually impaired for years, and therapeutic options for those patients hardly exist. Vision restoration therapy is a software-based visual training program that has been shown to improve visual deficits after pre- and postchiasmatic injury. The aim of this pilot study is to evaluate whether residual visual deficits after past or recent optic neuritis can be reduced by means of vision restoration therapy.
Methods/design
A randomized, controlled, patient- and observer-blinded clinical pilot study (VISION study) was designed to evaluate the efficacy of vision restoration therapy in optic neuritis patients. Eighty patients with a residual visual deficit after optic neuritis (visual acuity ≤0.7 and/or scotoma) will be stratified according to the time of optic neuritis onset (manifestation more than 12 months ago (40 patients, fixed deficit) versus manifestation 2 to 6 months ago (40 patients, recent optic neuritis)), and randomized into vision restoration therapy arm or saccadic training arm (control intervention). Patients will be instructed to complete a computer-based visual training for approximately 30 minutes each day for a period of 6 months. Patients and evaluators remain blinded to the treatment allocation throughout the study. All endpoints will be analyzed and P-values < 0.05 will be considered statistically significant. The primary outcome parameter will be the expansion of the visual field after 3 and 6 months of treatment as determined by static visual field perimetry and high resolution perimetry. Secondary outcome variables will include visual acuity at both low and high contrast, glare contrast sensitivity, visually evoked potentials, optical coherence tomography and other functional tests of the visual system, alertness, health-related quality of life, fatigue, and depression.
Discussion
If vision restoration therapy is shown to improve visual function after optic neuritis, this method might be a first therapeutic option for patients with incomplete recovery from optic neuritis.
Trial registration
NCT01274702
doi:10.1186/1745-6215-13-94
PMCID: PMC3408329  PMID: 22742888
Multiple sclerosis; Neuroplasticity; Optic neuritis; Treatment; Vision restoration therapy; Visual function
8.  Effectiveness of conventional versus virtual reality based vestibular rehabilitation in the treatment of dizziness, gait and balance impairment in adults with unilateral peripheral vestibular loss: a randomised controlled trial 
Background
Unilateral peripheral vestibular loss results in gait and balance impairment, dizziness and oscillopsia. Vestibular rehabilitation benefits patients but optimal treatment remains unkown. Virtual reality is an emerging tool in rehabilitation and provides opportunities to improve both outcomes and patient satisfaction with treatment. The Nintendo Wii Fit Plus® (NWFP) is a low cost virtual reality system that challenges balance and provides visual and auditory feedback. It may augment the motor learning that is required to improve balance and gait, but no trials to date have investigated efficacy.
Methods/Design
In a single (assessor) blind, two centre randomised controlled superiority trial, 80 patients with unilateral peripheral vestibular loss will be randomised to either conventional or virtual reality based (NWFP) vestibular rehabilitation for 6 weeks. The primary outcome measure is gait speed (measured with three dimensional gait analysis). Secondary outcomes include computerised posturography, dynamic visual acuity, and validated questionnaires on dizziness, confidence and anxiety/depression. Outcome will be assessed post treatment (8 weeks) and at 6 months.
Discussion
Advances in the gaming industry have allowed mass production of highly sophisticated low cost virtual reality systems that incorporate technology previously not accessible to most therapists and patients. Importantly, they are not confined to rehabilitation departments, can be used at home and provide an accurate record of adherence to exercise. The benefits of providing augmented feedback, increasing intensity of exercise and accurately measuring adherence may improve conventional vestibular rehabilitation but efficacy must first be demonstrated.
Trial registration
Clinical trials.gov identifier: NCT01442623
doi:10.1186/1472-6815-12-3
PMCID: PMC3394213  PMID: 22449224
Rehabilitation; Vestibular diseases; Nintendo Wii Fit Plus®; Virtual reality; Postural balance; Dizziness; Vertigo; Gait; Visual acuity; Feedback sensory
9.  Psychological and Cognitive Determinants of Vision Function in Age-Related Macular Degeneration 
Archives of ophthalmology  2011;129(7):885-890.
Objective
To investigate the effect of coping strategies, depression, physical health, and cognition on National Eye Institute Visual Function Questionnaire scores obtained at baseline in a sample of older patients with age-related macular degeneration (AMD) enrolled in the Improving Function in AMD Trial, a randomized controlled clinical trial that compares the efficacy of problem-solving therapy with that of supportive therapy to improve vision function in patients with AMD.
Methods
Baseline evaluation of 241 older outpatients with advanced AMD who were enrolled in a clinical trial testing the efficacy of a behavioral intervention to improve vision function. Vision function was characterized as an interval-scaled, latent variable of visual ability based on the near-vision subscale of the National Eye Institute Vision Function Questionnaire-25 plus Supplement.
Results
Visual ability was highly correlated with visual acuity. However, a multivariate model revealed that patient coping strategies and cognitive function contributed to their ability to perform near-vision activities independent of visual acuity.
Conclusions
Patients with AMD vary in their coping strategies and cognitive function and in their visual acuity, and that variability determines patients’ self-report of vision function. Understanding patient coping mechanisms and cognition may help increase the precision of vision rating scales and suggest new interventions to improve vision function and quality of life in patients with AMD.
Trial Registration
clinicaltrials.gov Identifier: NCT00572039
doi:10.1001/archophthalmol.2011.146
PMCID: PMC3584644  PMID: 21746979
10.  Computational disease modeling – fact or fiction? 
BMC Systems Biology  2009;3:56.
Background
Biomedical research is changing due to the rapid accumulation of experimental data at an unprecedented scale, revealing increasing degrees of complexity of biological processes. Life Sciences are facing a transition from a descriptive to a mechanistic approach that reveals principles of cells, cellular networks, organs, and their interactions across several spatial and temporal scales. There are two conceptual traditions in biological computational-modeling. The bottom-up approach emphasizes complex intracellular molecular models and is well represented within the systems biology community. On the other hand, the physics-inspired top-down modeling strategy identifies and selects features of (presumably) essential relevance to the phenomena of interest and combines available data in models of modest complexity.
Results
The workshop, "ESF Exploratory Workshop on Computational disease Modeling", examined the challenges that computational modeling faces in contributing to the understanding and treatment of complex multi-factorial diseases. Participants at the meeting agreed on two general conclusions. First, we identified the critical importance of developing analytical tools for dealing with model and parameter uncertainty. Second, the development of predictive hierarchical models spanning several scales beyond intracellular molecular networks was identified as a major objective. This contrasts with the current focus within the systems biology community on complex molecular modeling.
Conclusion
During the workshop it became obvious that diverse scientific modeling cultures (from computational neuroscience, theory, data-driven machine-learning approaches, agent-based modeling, network modeling and stochastic-molecular simulations) would benefit from intense cross-talk on shared theoretical issues in order to make progress on clinically relevant problems.
doi:10.1186/1752-0509-3-56
PMCID: PMC2697138  PMID: 19497118
11.  RPE65: Role in the visual cycle, human retinal disease, and gene therapy 
Ophthalmic genetics  2009;30(2):57.
RPE65 is an isomerohydrolase expressed in retinal pigment epithelium. It is critical for the regeneration of the visual pigment necessary for both rod and cone-mediated vision. Mutations in human RPE65 cause Leber’s congenital amaurosis and other forms of autosomal recessive retinitis pigmentosa which are associated with early-onset blindness. Several RPE65 animal models including two different mouse models and a naturally occurring canine model have been thoroughly characterized to determine the mechanisms that underlie RPE65 associated retinal dystrophies. More recently, substantial effort has gone into designing gene therapies for these diseases. Based on several encouraging reports from animal models, at least three clinical trials are currently underway for the treatment of LCA using modified AAV vectors carrying the RPE65 cDNA and have reported positive preliminary results.
doi:10.1080/13816810802626399
PMCID: PMC2821785  PMID: 19373675
RPE65; retinal pigment epithelium; retina; LCA; gene therapy
12.  Scoliosis: Facts and Fiction for the Family Physician 
Canadian Family Physician  1975;21(9):92-94.
Idiopathic scoliosis is a common deformity in the adolescent age group. It is now known to be a hereditary condition, demanding careful family scrutiny. Furthermore, studies of the natural history have proven its serious long term consequences. As spinal curvatures may progress insidiously and relentlessly, early diagnosis becomes the hallmark of management. Mass screening for spinal curvatures by family physicians and medical resource personnel is recommended as a practical approach to early definition of this problem.
Images
PMCID: PMC2274706  PMID: 20469235
13.  Microsatellite Instability in Sarcoma: Fact or Fiction? 
ISRN Oncology  2012;2012:473146.
Microsatellite instability (MSI) is a unique molecular abnormality, indicative of a deficient DNA mismatch repair (MMR) system. Described and characterized in the colorectal cancer literature, the MSI-positive phenotype is predictive of disease susceptibility, pathogenesis, and prognosis. The clinical relevance of MSI in colorectal cancer has inspired similar inquisition within the sarcoma literature, although unfortunately, with very heterogeneous results. Evolving detection techniques, ill-defined sarcoma-specific microsatellite loci and small study numbers have hampered succinct conclusions. The literature does suggest that MSI in sarcoma is observed at a frequency similar to that of sporadic colorectal cancers, although there is little evidence to suggest that MSI-positive tumors share distinct biological attributes. Emerging evidence in Ewing sarcoma has demonstrated an intriguing mechanistic role of microsatellite DNA in the activation of key EWS/FLI-target genes. These findings provide an alternative perspective to the biological implications of microsatellite instability in sarcoma and warrant further investigation using sophisticated detection techniques, sensitive microsatellite loci, and appropriately powered study designs.
doi:10.5402/2012/473146
PMCID: PMC3564276  PMID: 23401795
14.  Venous disease: investigation and treatment, fact or fiction? 
This review looks at some clinical and experimental methods and treatments used in venous disease, and attempts to dispel some myths which have been associated with it. Over the last century numerous techniques have been introduced to aid the understanding of the physiology of normal legs and the pathophysiology of those with venous disease. Tourniquet testing along with clinical examination remains the only method of venous assessment in most hospitals. Venous ulceration in the past has been associated with deep vein incompetence, but the newer, non-invasive techniques of Doppler ultrasound and duplex examination are now identifying patients with leg ulceration who have superficial venous insufficiency and therefore a surgically correctable condition. Perforating veins and their possible role in the aetiology of venous ulceration along with invasive and non-invasive methods for their detection is reviewed. Some of the conservative compression treatments and dressings available for the treatment of venous ulceration are discussed. It is concluded that adherence to sound surgical principles remains the mainstay of the successful management of patients with venous disease.
PMCID: PMC2499160  PMID: 2192676
15.  Current management of diabetic retinopathy. 
Western Journal of Medicine  1992;157(1):67-70.
Diabetic retinopathy progresses through three distinct stages. A rational approach to management is based on an understanding of the pathophysiology of each stage. Based on the results of national multicentered clinical trials of laser photocoagulation and other treatments, advances in our understanding of the pathogenesis and treatment can now make a dramatic impact on blindness in the diabetic population: Panretinal laser photocoagulation treatment can reduce the risk of vision loss from high-risk proliferative diabetic retinopathy by at least 50%. Laser photocoagulation treatment of clinically significant diabetic macular edema can reduce the risk of vision loss by more than 50%. Vitrectomy can restore useful vision to some patients with severe diabetic retinopathy and vitreous hemorrhage with or without an accompanying traction retinal detachment. Diabetes 2000 is a new project sponsored by the American Academy of Ophthalmology, the goal of which is to eliminate preventable blindness from diabetes by the year 2000. As its name implies, Diabetes 2000 will be a long-term project aimed at a specific disease--diabetic retinopathy and its complications. It will provide the latest research findings to ophthalmologists and primary care physicians as the first priority, followed by the education of patients and the general public. Recent advances and treatment guidelines for the medical and surgical treatment of diabetic eye disease will be emphasized through the continuing education of ophthalmologists, other physicians, and allied health professionals. In later phases, educational programs for diabetic persons and the public will be developed.(ABSTRACT TRUNCATED AT 250 WORDS)
Images
PMCID: PMC1021914  PMID: 1413752
16.  Non-traditional therapies for diabetes: fact or fiction 
The number of medications now available to treat Type 2 Diabetes has been expanding quickly over the past two decades. At the same time, the use of complementary and alternative medicine (CAM) has also been rising. Individuals with diabetes are 1.6 times more likely than those without diabetes to use modalities that are not considered part of conventional medicine. Numerous dietary supplements are available over the counter and are being advertized to treat diabetes and its co morbidities. No conclusive data on their clinical benefit, potential harms, dosing or interaction with other medications is yet available. But for clinicians to maintain a trusting relationship with their patient, a respectful non-confrontational attitude is needed to encourage open dialogue, provide accurate information, and facilitate changes to the medical regimen. It is essential that clinicians stay informed and advise their patient with the available scientific data accordingly. In this review, we focus on current data on six supplements commonly encountered in community practice for treating diabetes, including cinnamon, fenugreek, vinegar, ginseng, bitter melon, gymnema, chromium, and vanadium.
doi:10.3402/jchimp.v2i2.18447
PMCID: PMC3714056  PMID: 23882364
complementary and alternative medicine; Diabetes Mellitus; cinnamon; vinegar; fenugreek; ginseng; bitter melon; gymnema; chromium; vanadium
17.  Gene expression profiling of the brain: pondering facts and fiction 
Neurobiology of disease  2011;45(1):3-7.
During the last decade brain transcriptome profiling by DNA microarrays has matured, developed sound experimental design standards, reporting practices, analytical procedures, and data sharing resources. It has become a powerful scientific tool in the exploratory research portfolio. Along this journey by trial and error, we encountered a number of intriguing questions and comments - pondering the value of hypothesis-driven research, appropriate sample size, the importance and interpretation of transcripts changes vis-à-vis protein changes, the role of statistical stringency, false discovery and magnitude of expression change, and many other interesting questions. Our field fully acknowledges and tries to address all of these challenges associated with high-throughput, data-driven transcriptomics. As a research field, we strongly advocate implementing the highest standards of our trade, and we deeply believe that transcriptome profiling studies will continue to be essential for deciphering the pathophysiological mechanisms leading to complex brain disorders.
doi:10.1016/j.nbd.2011.06.001
PMCID: PMC3210391  PMID: 21689753
DNA microarray; transcriptome; brain; gene expression; data interpretation; experimental design; schizophrenia; psychiatric disorder
18.  Nanodentistry: A Paradigm Shift-from Fiction to Reality 
Nanodentistry is an emerging field with significant potential to yield new generation of technologically advanced clinical tools and devices for oral healthcare. Nanoscale topology and quantitative biomechanical or biophysical analysis of dental surfaces are of significant interest. In particular, using Atomic force microscopy techniques—diseases such as dental caries, tooth hypersensitivity, and oral cancer can be quantified based on morphological, biophysical and biochemical nanoscale properties of tooth surface itself and dental materials or oral fluids such as saliva. An outlook on future “nanodentistry” developments such as saliva exosomes based diagnostics, designing biocompatible, antimicrobial dental implants and personalized dental healthcare is presented. This article examines current applications of nanotechnology alongside proposed applications in the future and aims to demonstrate that, as well as a good deal of science fiction, there is some tangible science fact emerging from this novel multidisciplinary science.
doi:10.1007/s13191-011-0062-0
PMCID: PMC3095743  PMID: 22379298
Nano-characterization; Nanodentistry; Biofilms; Implants; Atomic force microscopy; Nanodentistry “top-down” and “bottom-up”; Nanorobots
19.  Thymoquinone in the clinical treatment of cancer: Fact or fiction? 
Pharmacognosy Reviews  2013;7(14):117-120.
Thymoquinone (TQ) is the bioactive phytochemical constituent of the seeds oil of Nigella sativa. In vitro and in vivo research has thoroughly investigated the anticancer effects of TQ against several cancer cell lines and animal models. As a result, a considerable amount of information has been generated from research thus providing a better understanding of the anti-proliferating activity of this compound. Therefore, it is appropriate that TQ should move from testing on the bench to clinical experiments. The purpose of this review is to highlight the potential of TQ as an anticancer agent and the chances of this compound in the clinical treatment of cancer, with special attention on breast cancer treatment.
doi:10.4103/0973-7847.120509
PMCID: PMC3841989  PMID: 24347919
Breast cancer; drug delivery; pharmacokinetics; thymoquinone
20.  Barriers for Retinal Gene Therapy: Separating Fact from Fiction 
Vision research  2008;48(16):1671-1680.
The majority of recent preclinical gene therapy studies targeting the retina have used adeno-associated virus (AAV) as the gene transfer vector. However, AAV has several limitations including the ability to generate innate inflammatory responses, the ability to cause insertional mutagenesis at a frequency of up to 56% in some tissues and a limited cloning capacity of 4.8Kb. Furthermore, AAV is known to generate limiting immune responses in humans despite the absence of similar immune responses in preclinical canine and murine studies. Three clinical trials to treat Leber’s congenital amaurosis using AAV are under way. A clinical trial to treat Stargardt’s using lentivirus vectors has also been recently announced. However, very limited evidence currently exists that lentivirus vectors can efficiently transduce photoreceptor cells. In contrast, very few preclinical ocular gene therapy studies have utilized adenovirus as the gene therapy vector. Nonetheless, the only two ocular gene therapy clinical trials performed to date have each used adenovirus as the vector and more significantly, in these published trials there has been no observed serious adverse event. These trials appear to be poised for Phase II/III status. Activation of cytotoxic T lymphocytes limits duration of transgene expression in the retina from first generation adenovirus vectors. However, an advanced class of adenovirus vectors referred to as Helper-dependent Adenovirus (Hd-Ad) have recently been shown to be capable of expressing transgenes in ocular tissues for more than one year. Hd-Ad vectors have many properties that potentially warrant their inclusion in the retinal gene therapy toolbox for the treatment of retinal degenerative diseases.
doi:10.1016/j.visres.2008.05.005
PMCID: PMC2538423  PMID: 18565565
21.  The FiCTION dental trial protocol – filling children’s teeth: indicated or not? 
BMC Oral Health  2013;13:25.
Background
There is a lack of evidence for effective management of dental caries (decay) in children’s primary (baby) teeth and an apparent failure of conventional dental restorations (fillings) to prevent dental pain and infection for UK children in Primary Care. UK dental schools’ teaching has been based on British Society of Paediatric Dentistry guidance which recommends that caries in primary teeth should be removed and a restoration placed. However, the evidence base for this is limited in volume and quality, and comes from studies conducted in either secondary care or specialist practices. Restorations provided in specialist environments can be effective but the generalisability of this evidence to Primary Care has been questioned.
The FiCTION trial addresses the Health Technology Assessment (HTA) Programme’s commissioning brief and research question “What is the clinical and cost effectiveness of restoration caries in primary teeth, compared to no treatment?” It compares conventional restorations with an intermediate treatment strategy based on the biological (sealing-in) management of caries and with no restorations.
Methods/Design
This is a Primary Care-based multi-centre, three-arm, parallel group, patient-randomised controlled trial. Practitioners are recruiting 1461 children, (3–7 years) with at least one primary molar tooth where caries extends into dentine. Children are randomized and treated according to one of three treatment approaches; conventional caries management with best practice prevention, biological management of caries with best practice prevention or best practice prevention alone.
Baseline measures and outcome data (at review/treatment during three year follow-up) are assessed through direct reporting, clinical examination including blinded radiograph assessment, and child/parent questionnaires.
The primary outcome measure is the incidence of either pain or infection related to dental caries.
Secondary outcomes are; incidence of caries in primary and permanent teeth, patient quality of life, cost-effectiveness, acceptability of treatment strategies to patients and parents and their experiences, and dentists’ preferences.
Discussion
FiCTION will provide evidence for the most clinically-effective and cost-effective approach to managing caries in children’s primary teeth in Primary Care. This will support general dental practitioners in treatment decision making for child patients to minimize pain and infection in primary teeth. The trial is currently recruiting patients.
Trial registration
Protocol ID: NCTU: ISRCTN77044005
doi:10.1186/1472-6831-13-25
PMCID: PMC3698078  PMID: 23725316
Dental caries; Caries prevention; Primary teeth; Prevention; Paediatric Dentistry; Restoration; Fillings; RCT; Primary care
22.  Facts and Fiction: The Impact of Hypothermia on Molecular Mechanisms following Major Challenge 
Mediators of Inflammation  2012;2012:762840.
Numerous multiple trauma and surgical patients suffer from accidental hypothermia. While induced hypothermia is commonly used in elective cardiac surgery due to its protective effects, accidental hypothermia is associated with increased posttraumatic complications and even mortality in severely injured patients. This paper focuses on protective molecular mechanisms of hypothermia on apoptosis and the posttraumatic immune response. Although information regarding severe trauma is limited, there is evidence that induced hypothermia may have beneficial effects on the posttraumatic immune response as well as apoptosis in animal studies and certain clinical situations. However, more profound knowledge of mechanisms is necessary before randomized clinical trials in trauma patients can be initiated.
doi:10.1155/2012/762840
PMCID: PMC3316953  PMID: 22481864
23.  Exacerbation of chronic inflammatory diseases by infectious agents: Fact or fiction? 
World Journal of Diabetes  2010;1(2):27-35.
Chronic inflammatory diseases caused by obesity represent critical public health concerns worldwide. In these diseases such as metabolic syndrome, diabetes and atherosclerosis, adipose tissue acts as an endocrine organ that releases large quantities of inflammatory mediators into circulation. Besides classically recognized effectors on the development of obesity and resultant conditions, infection has attracted attention as an enhancer of chronic inflammatory diseases. Infectious diseases have long been associated with obesity, metabolic syndrome, diabetes and atherosclerosis. However, the infectious hypothesis for chronic inflammatory diseases has been challenged by inconclusive clinical trials. Nevertheless, the large body of evidence accumulated over decades on the association of infectious diseases with obesity, diabetes and cardiovascular disease should not be disregarded. Instead, re-formulation of hypotheses of the mechanisms by which microbes affect obesity-associated diseases may be required with an emphasis on the early events in the progression of such diseases and the multifactorial nature of pathogen-host interactions. This review focuses on pathogens that directly promote obesity and on pathogens that cause chronic infections and thereby enhance metabolic diseases in obese patients. A new perspective on the interaction between infections and obesity-related diseases may improve management of chronic inflammatory diseases that rank high among global threats to human health.
doi:10.4239/wjd.v1.i2.27
PMCID: PMC3083881  PMID: 21537425
Chronic inflammatory diseases; Obesity; Diabetes; Adenovirus-36; Chlamydia pneumoniae
24.  Effect of virtual reality training on laparoscopic surgery: randomised controlled trial 
Objective To assess the effect of virtual reality training on an actual laparoscopic operation.
Design Prospective randomised controlled and blinded trial.
Setting Seven gynaecological departments in the Zeeland region of Denmark.
Participants 24 first and second year registrars specialising in gynaecology and obstetrics.
Interventions Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls).
Main outcome measure The main outcome measure was technical performance assessed by two independent observers blinded to trainee and training status using a previously validated general and task specific rating scale. The secondary outcome measure was operation time in minutes.
Results The simulator trained group (n=11) reached a median total score of 33 points (interquartile range 32-36 points), equivalent to the experience gained after 20-50 laparoscopic procedures, whereas the control group (n=10) reached a median total score of 23 (22-27) points, equivalent to the experience gained from fewer than five procedures (P<0.001). The median total operation time in the simulator trained group was 12 minutes (interquartile range 10-14 minutes) and in the control group was 24 (20-29) minutes (P<0.001). The observers’ inter-rater agreement was 0.79.
Conclusion Skills in laparoscopic surgery can be increased in a clinically relevant manner using proficiency based virtual reality simulator training. The performance level of novices was increased to that of intermediately experienced laparoscopists and operation time was halved. Simulator training should be considered before trainees carry out laparoscopic procedures.
Trial registration ClinicalTrials.gov NCT00311792.
doi:10.1136/bmj.b1802
PMCID: PMC3273782  PMID: 19443914
25.  Treatmenf of optic neuritis by retrobulbar injection of triamcinolone. 
British Medical Journal  1977;1(6075):1495-1497.
In a single-blind controlled clinical trial patients with optic neuritis caused by demyelination were given a single retrobulbar injection of triamcinolone. Though the treated group showed a trend towards more rapid recovery of vision than the controls, there was no significant difference in visual acuity, colour vision, or visual fields during the first six months after treatment. We conclude that routine use of corticosteroids is not justified in unilateral optic neuritis when vision in the other eye is good. Shortening the period of visual disability in bilateral disease or unilateral disease when vision in the other eye is poor, however, may be justifiable.
PMCID: PMC1607274  PMID: 326332

Results 1-25 (443578)