Huynh Le Maux, Amélie; Pignol, Bernadette; Behr-Roussel, Delphine; Blachon, Jean-Luc; Chabrier, Pierre-Etienne; Compagnie, Sandrine; Picaut, Philippe; Bernabé, Jacques; Giuliano, François; Denys, Pierre
Intradetrusor injections of Botulinum toxin A—currently onabotulinumtoxinA—is registered as a second-line treatment to treat neurogenic detrusor overactivity (NDO). The common clinical practice is 30 × 1 mL injections in the detrusor; however, protocols remain variable and standardization is warranted. The effect of reducing the number of injection sites of Dysport® abobotulinumtoxinA (aboBoNTA) was assessed in the spinal cord-injured rat (SCI). Nineteen days post-spinalization, female rats received intradetrusor injections of saline or aboBoNTA 22.5 U distributed among four or eight sites. Two days after injection, continuous cystometry was performed in conscious rats. Efficacy of aboBoNTA 22.5 U was assessed versus aggregated saline groups on clinically-relevant parameters: maximal pressure, bladder capacity, compliance, voiding efficiency, as well as amplitude, frequency, and volume threshold for nonvoiding contractions (NVC). AboBoNTA 22.5 U significantly decreased maximal pressure, without affecting voiding efficiency. Injected in four sites, aboBoNTA significantly increased bladder capacity and compliance while only the latter when in eight sites. AboBoNTA significantly reduced NVC frequency and amplitude. This preclinical investigation showed similar inhibiting effects of aboBoNTA despite the number of sites reduction. Further studies are warranted to optimize dosing schemes to improve the risk-benefit ratio of BoNTA-based treatment modalities for NDO and further idiopathic overactive bladder. PMID:26694464
Wohlfarth, K; Schwandt, I; Wegner, F; Jürgens, T; Gelbrich, G; Wagner, A; Bogdahn, U; Schulte-Mattler, W
Despite extensive clinical experience and published data regarding botulinum toxin, questions remain about the clinical substitution of one botulinum toxin formulation for another. In the case of Dysport and Botox, dose-equivalence ratios ranging from 1:1 to 6:1 (Dysport:Botox) have been advocated. This dose-ranging, electroneurographic study investigated the dose equivalence, diffusion characteristics (spread) and safety of these two type-A toxins in 79 volunteers. Dysport and Botox caused significant and similar reductions in compound muscle action potential (CMAP) amplitude in the target muscle (extensor digitorum brevis, EDB) 2 weeks after injection, with effects persisting to the 12-week timepoint. For both products, the reduction in amplitude was increased with increasing doses and with increasing concentration. The effects of toxin on neighbouring muscles were much smaller and of a shorter duration than those on the target muscle, implying a modest spread of toxin. Unlike the target muscle, the effects were greater with the higher volume, suggesting this volume led to greater diffusion from the EDB. No adverse events were reported. Statistical modelling with CMAP amplitude data from the target muscle gave a bioequivalence of 1.57 units of Dysport:1 unit of Botox (95 % CI: 0.77-3.20 units). The data indicate that a dose-equivalence ratio of 3:1 was within the statistical error limits, but ratios over 3:1 are too high.
Yun, Ji Young; Kim, Jae Woo; Kim, Hee-Tae; Chung, Sun Ju; Kim, Jong-Min; Cho, Jin Whan; Lee, Jee-Young; Lee, Ha Neul; You, Sooyeoun; Oh, Eungseok; Jeong, Heejeong; Kim, Young Eun; Kim, Han-Joon; Lee, Won Yong; Jeon, Beom S
We aimed to compare Dysport (abobotulinumtoxinA, Ipsen Biopharm, Slough, UK) and Botox (onabotulinumtoxinA, Allergan, Irvine, CA, USA) at a 2.5:1 ratio in the treatment of cervical dystonia (CD). A Dysport/Botox ratio of lower than 3:1 was suggested as a more appropriate conversion ratio, considering its higher efficacy and more frequent incidence of adverse effects not only in the treatment of CD but also in other focal movement disorders. A randomized, double-blind, multicenter, non-inferiority, two-period crossover study was done in CD, with a duration of at least 18 months. Patients were randomly assigned to treatment for the first period with Dysport or Botox, and they were followed up for 16 weeks after the injection. After a 4-week washout period, they were switched to the other formulation and then followed up for 16 weeks. The primary outcome was the changes in the Tsui scale between the baseline value and that at 1 month after each injection. A total of 103 patients were enrolled, and 94 completed the study. Mean changes in the Tsui scale between baseline and 4 weeks after each injection tended to favor Botox; however, this was not statistically significant (4.0 ± 3.9 points for the Dysport treatment vs. 4.8 ± 4.1 points for Botox; 95% confidence interval, -0.1-1.7; P = 0.091). The mean change of the Toronto western spasmodic torticollis rating scale score, the proportion of improvement in clinical global impression and patient global impression, and the incidences of adverse events were not significantly different between the two treatments. With regard to safety and efficacy, Dysport was not inferior to Botox in patients with CD at a conversion factor of 2.5:1. [clinicaltrial.gov: NCT00950664
Kollewe, Katja; Mohammadi, Bahram; Köhler, Steffen; Pickenbrock, Heidrun; Dengler, Reinhard; Dressler, Dirk
Botulinum toxin (BT) therapy is the treatment of choice for blepharospasm (BPS). Currently available BT type A drugs include Botox(®), Dysport(®) and Xeomin(®). Until now, there are few long-term studies on BT therapy for BPS. This is the first long-term study comparing all three major BT drugs. We collected treatment, efficacy and adverse effect data on BPS patients treated with either Botox(®), Dysport(®) or Xeomin(®) for at least eight consecutive treatments. Two hundred and eighty-eight patients (208 females, 80 males, age 62 ± 12 years) were included in this study. The treatment time was 11.2 ± 4.1 years covering 10,701 injection series. Doses were 47 ± 10 MU for Botox(®), 120 ± 35 MU for Dysport(®) and 62 ± 11 MU for Xeomin(®) (Botox(®) dose vs Xeomin(®) dose: p < 0.001, unpaired t test). 85 % of all patients had stable doses. The onset of the therapeutic effect was after 6.1 ± 3.3 days and its duration lasted 10.2 ± 3.5 weeks. The Global Clinical Improvement (GCI, 0 = no, 1 = slight, 2 = moderate, 3 = marked improvement in severity and function) as estimated by the patient was 2.5 ± 0.6. It was stable in 90% of the patients. Adverse effect frequency was 3.0% (ptosis 2.3%, dry eye 0.5%, diplopia 0.2%). None of these findings was significantly different between Botox(®), Dysport(®) and Xeomin(®). Our study, one of the largest studies on BT therapy of BPS and the study with the longest follow-up, confirms that BT therapy produces robust clinical improvement which is stable throughout the treatment time. Therapeutic effects start after 6.1 days and last for about 10 weeks before they start to vanish. With this, they are approximately 2 weeks shorter than the recommended inter-injection interval. Adverse effects were rare, mild and always transient. BT therapy is a safe and effective treatment for BSP. Shorter inter-injection intervals may improve therapeutic results.
Hefter, H; Benecke, R; Erbguth, F; Jost, W; Reichel, G; Wissel, J
Objectives It remains to be determined whether the benefits of botulinum toxin type A (BoNT-A) on cervical dystonia (CD) motor symptoms extend to improvements in patient's quality of life (QoL). This analysis of a large, multicentre study was conducted with the aim of investigating changes in QoL and functioning among de novo patients receiving 500 U BoNT-A (abobotulinumtoxinA; Dysport) for the treatment of the two most frequent forms of CD, predominantly torticollis and laterocollis. Design A prospective, open-label study of Dysport (500 U; Ipsen Biopharm Ltd) administered according to a defined intramuscular injection algorithm. Setting German and Austrian outpatient clinics. Participants 516 male and female patients (aged ≥18 years) with de novo CD. The majority of patients had torticollis (78.1%). 35 patients had concomitant depression (MedDRA-defined). Main outcome measures Change from baseline to weeks 4 and 12 in Craniocervical Dystonia Questionnaire (CDQ-24) total and subscale scores, patient diary items (‘day-to-day capacities and activities’, ‘pain’ and ‘duration of pain’) and global assessment of pain. Results Significant improvements were observed in CDQ-24 total and subscale scores at week 4 and were sustained up to week 12 (p<0.001). Changes in CDQ-24 scores did not significantly differ between the torticollis and laterocollis groups or between patients with or without depression. There were also significant reductions in patient diary item scores for activities of daily living, pain and pain duration at weeks 4 and 12 (p<0.001). Pain relief (less or no pain) was reported by 66% and 74.1% of patients at weeks 4 and 12, respectively. Changes in pain parameters demonstrated a positive relationship with change in Tsui score. Conclusions After standardised open-label treatment with Dysport 500 U, improvements in QoL and pain intensity up to 12 weeks in patients with CD were observed. PMID:23604344
Factors affecting the health-related quality of life of patients with cervical dystonia and impact of treatment with abobotulinumtoxinA (Dysport): results from a randomised, double-blind, placebo-controlled study
Mordin, Margaret; Masaquel, Catherine; Abbott, Chandra; Copley-Merriman, Catherine
Objective To describe the health-related quality of life (HRQOL) burden of cervical dystonia (CD) and report on the HRQOL and patient perception of treatment benefits of abobotulinumtoxinA (Dysport). Design The safety and efficacy of a single injection of abobotulinumtoxinA for CD treatment were evaluated in a previously reported international, multicenter, double-blind, randomised trial. HRQOL measures were assessed in the trial and have not been previously reported. Setting Movement disorder clinics in the USA and Russia. Participants Patients had to have a diagnosis of CD with symptoms for at least 18 months, as well as a total Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score of at least 30; a Severity domain score of at least 15; and a Disability domain score of at least 3. Key exclusion criteria included treatment with botulinum toxin type A (BoNT-A) or botulinum toxin type B (BoNT-B) within 16 weeks of enrolment. Interventions Patients were randomised to receive either 500 U abobotulinumtoxinA (n=55) or placebo (n=61). Primary and secondary outcome measures Efficacy assessments included TWSTRS total (primary end point) and subscale scores at weeks 0, 4, 8, 12; a pain visual analogue scale at weeks 0 and 4; and HRQOL assessed by the SF-36 Health Survey (SF-36; secondary end point) at weeks 0 and 8. Results Patients with CD reported significantly greater impairment for all SF-36 domains relative to US norms. Patients treated with abobotulinumtoxinA reported significantly greater improvements in Physical Functioning, Role Physical, Bodily Pain, General Health and Role Emotional domains than placebo patients (p≤0.03 for all). The TWSTRS was significantly correlated with Physical Functioning, Role Physical and Bodily Pain scores, for those on active treatment. Conclusions CD has a marked impact on HRQOL. Treatment with a single abobotulinumtoxinA injection results in significant improvement in patients’ HRQOL. Trial registration number The
Jost, Wolfgang H; Hefter, Harald; Reissig, Andrea; Kollewe, Katja; Wissel, Joerg
The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement'). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation.
Dashtipour, Khashayar; Chen, Jack J.; Frei, Karen; Nahab, Fatta; Tagliati, Michele
Background The aim was to elucidate clinical trial efficacy, safety, and dosing practices of abobotulinumtoxinA (ABO) treatment in adult patients with blepharospasm and hemifacial spasm. To date, most literature reviews for blepharospasm and hemifacial spasm have examined the effectiveness of all botulinum neurotoxin type A products as a class. However, differences in dosing units and recommended schemes provide a clear rationale for reviewing each product separately. Methods A systematic literature review was performed to identify randomized controlled trials and other comparative clinical studies of ABO in the treatment of blepharospasm and hemifacial spasm published in English between January 1991 and March 2015. Medical literature databases (PubMed, Cochrane library, EMBASE) were searched. A total of five primary publications that evaluated ABO for the management of blepharospasm and hemifacial spasm were identified and summarized. Results Data included 374 subjects with blepharospasm and 172 subjects with hemifacial spasm treated with ABO. Total ABO doses ranged between 80 and 340 U for blepharospasm and 25 and 85 U for hemifacial spasm, depending on the severity of the clinical condition. All studies showed statistically significant benefits for the treatment of blepharospasm and hemifacial spasm. ABO was generally well tolerated across the individual studies. Adverse events considered to be associated with ABO treatment included: ptosis, tearing, blurred vision, double vision, dry eyes, and facial weakness. Discussion These data from 5 randomized clinical studies represents the available evidence base of ABO in blepharospasm and hemifacial spasm. Future studies in this area will add to this evidence base. PMID:26566457
Dashtipour, Khashayar; Chen, Jack J; Walker, Heather W; Lee, Michael Y
To elucidate clinical trial efficacy, safety, and dosing practices of AbobotulinumtoxinA (ABO) treatment in adult patients with lower limb spasticity.A systematic literature review was performed to identify randomized controlled trials of ABO in the treatment of adult lower limb spasticity.Of the 295 records identified, 6 primary publications evaluated ABO for the management of lower limb spasticity of various etiologies and were evaluated. Total ABO doses ranged between 500 and 2000 U for lower limb spasticity, depending on the muscles injected. All studies in lower limb spasticity showed statistically significant reduction in muscle tone based on Modified Ashworth Scale of ABO versus placebo. Significant effects on active movement and pain were demonstrated albeit less consistently. ABO was generally well tolerated across the individual studies; most adverse events reported were considered unrelated to treatment. Treatment-related adverse events included but not limited to fatigue, local pain at injection site, hypertonia, dry mouth, weakness of the noninjected muscle, abnormal gait, and urinary tract infection.These data from 6 randomized clinical studies provide the beginnings of an evidence base for the use of ABO to reduce lower limb spasticity. Ongoing studies in this area will add to this evidence base.
... Sponsors Why Are They Important How Do They Work Who Can Participate What To Expect During Benefits and Risks How They Protect Participants Finding Clinical Trials Links Children & Clinical Studies NHLBI Trials Clinical Trial Websites What Are Clinical ...
Shands, Harley C.; Meltzer, James D.
Clinical semiotics is defined and discussed as the discipline having to do with the interrelation between specifically human methods of communicating and processing information and specifically human psychiatric and psychosomatic disorders. (Author/RM)
Digital cameras, when used correctly, can provide the basis for telemedicine services. The increasing sophistication of digital cameras, combined with the improved speed and availability of the Internet, make them an instrument that every health-care professional should be familiar with. Taking satisfactory images of patients requires clinical photography skills. Photographing charts, monitors, X-ray films and specimens also requires expertise. Image capture using digital cameras is often done with insufficient attention, which can lead to inaccurate study results. The procedures in clinical photography should not vary from camera to camera, or from country to country. Taking a photograph should be a standardised process. There are seven main scenarios in clinical photography and health professionals who use cameras should be familiar with all of them. Obtaining informed consent prior to photography should be a normal part of the clinical photography routine.
Mazefsky, Carla A.; Minshew, Nancy J.
Autism spectrum disorders are defined behaviorally by the Diagnostic and Statistical Manual (DSM) IV-TR based on abnormal development in social interaction and communication and restricted, repetitive, and stereotyped patterns of behaviors and interests that are evident before the age of 3. After decades of debate, research has demonstrated that the distinctions among autism, Asperger disorder, and pervasive developmental disorder not otherwise specified are neither clinically reliable nor based on valid neurobiological or genetic differences. The fifth edition of the DSM therefore proposes to collapse all of the clinical syndromes under the single diagnosis of autism spectrum disorder (ASD). PMID:23186793
Tárnok, Attila; Mittag, Anja; Lenz, Dominik
The goal of predictive medicine is the detection of changes in patient's state prior to the clinical manifestation of the deterioration of the patients current status. Therefore, both the diagnostic of diseases like cancer, coronary atherosclerosis or congenital heart failure and the prognosis of the effect specific therapeutics on patients outcome are the main fields of predictive medicine. Clinical Cytomcs is based on the analysis of specimens from the patient by Cytomic technologies that are mainly imaging based techniques and their combinations with other assays. Predictive medicine aims at the recognition of the "fate" of each individual patients in order to yield unequivocal indications for decision making (i.e. how does the patient respond to therapy, react to medication etc.). This individualized prediction is based on the Predictive Medicine by Clinical Cytomics concept. These considerations have recently stimulated the idea of the Human Cytome Project. A major focus of the Human Cytome Project is multiplexed cy-tomic analysis of individual cells of the patient, extraction of predictive information and individual prediction that merges into individualized therapy. Although still at the beginning, Clinical Cytomics is a promising new field that may change therapy in the near future for the benefit of the patients.
Alexander, W. C.; Leach, C. S.; Fischer, C. L.
The objectives of the biochemical studies conducted for the Apollo program were (1) to provide routine laboratory data for assessment of preflight crew physical status and for postflight comparisons; (2) to detect clinical or pathological abnormalities which might have required remedial action preflight; (3) to discover as early as possible any infectious disease process during the postflight quarantine periods following certain missions; and (4) to obtain fundamental medical knowledge relative to man's adjustment to and return from the space flight environment. The accumulated data presented suggest that these requirements were met by the program described. All changes ascribed to the space flight environment were subtle, whereas clinically significant changes were consistent with infrequent illnesses unrelated to the space flight exposure.
Gilman, S.; Mazziotta, J.C.
Designed for practicing neurologists and neurosurgeons, this reference focuses on the newest techniques in computed assisted tomography. Text material covers basic principles of computed tomography, as well as the clinical advantages and disadvantages of each modality. The anatomical and/or physiological processes measured by XCT, PET, SPECT and MRI are first discussed in terms of the normal patient, and then applied to the diagnosis and treatment of patients with neurological disease (primarily of the brain). Emphasis is placed on areas of difficult diagnosis, such as differentiating recurrent tumor from radiation necrosis, early diagnosis of dementia, selection of patients for extracranial-intracranial bypass procedures, and localization of epileptic foci.
Arndt, R.; Horns, J.W.; Gold, R.H.; Blaschke, D.D.
This book deals with the method and interpretation of arthrography of the shoulder, knee, ankle, elbow, hip, wrist, and metacarpophalangeal, interphalangeal, and temporomandibular joints. The emphasis is on orthopaedic disorders, usually of traumatic origin, which is in keeping with the application of arthrography in clinical practice. Other conditions, such as inflammatory and degenerative diseases, congenital disorders and, in the case of the hip, arthrography of reconstructive joint surgery, are included. Each chapter is devoted to one joint and provides a comprehensive discussion on the method of arthrography, including single and double contrast techniques where applicable, normal radiographic anatomy, and finally, the interpretation of the normal and the abnormal arthrogram.
Miettinen, Olli S; Bachmann, Lucas M; Steurer, Johann
Clinical research must be understood to be the foundation of scientific medicine of the clinical type. But the essence of scientific clinical medicine remains a matter of profound confusion, even in clinical academia, and so does the essence of clinical research. The confusion now revolves, principally, around 'clinical epidemiology'. We address clinical research in the meaning of quintessentially 'applied' clinical research, which we take to be the foundation of the scientific knowledge base of clinical medicine, of gnosis (dia-, etio-, pro-) in it. More specifically, we address the essence, priorities, and status quo of this research - and argue that the requisite theory of this is not a matter of 'clinical epidemiology' but of theory of clinical research endogenous to clinical (rather than epidemiological) academia.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
Usually, in clinical practice the maneuver selected is the one that achieves a favorable outcome with a direct percentage of superiority of at least 10 %, or when the number needed to treat is approximately equal to 10. While this percentage difference is practical for estimating the magnitude of an association, we need to differentiate the impact measures (attributable risk, preventable fraction), measures of association (RR, OR, HR), and frequency measures (incidence and prevalence) applicable when the outcome is nominal. And we must identify ways to measure the strength of association and the magnitude of the association when the outcome variable is quantitative. It is not uncommon to interpret the measures of association as if they were impact measures. For example, for a RR of 0.68, it is common to assume a 32 % reduction of the outcome, but we must consider that this is a relative reduction, which comes from relations of 0.4/0.6, 0.04/0.06, or 0.00004/0.00006. However the direct reduction is 20 % (60 % - 40 %), 2 %, and 2 per 100,000, respectively. Therefore, to estimate the impact of a maneuver it is important to have the direct difference and/or NNT.
Smith, Phil Em; Mucklow, John C
Written knowledge assessments for physicians in training typically involve multiple-choice questions that use a clinical scenario in a single-best-answer format. The Royal College of Physicians Part 1 MRCP(UK) examination includes basic sciences themes that are challenging to assess through a clinical scenario. A realistic clinical setting based on everyday clinical practice and integral to the question is the clearest demonstration that the knowledge being assessed is clinically relevant. However, without special attention to detail, the scenario in a clinical science question can appear redundant or artificial. Reading unnecessary material frustrates candidates and threatens the reputation of the assessment. In this paper we discuss why a clinical scenario is important for basic science questions and offer advice on setting realistic and plausible clinical scenarios for such questions.
Bateman, D N
1. The aims of the present paper are to: (i) review progress in clinical toxicology over the past 40 years and to place it in the context of modern health care by describing its development; and (ii) illustrate the use of clinical toxicology data from Scotland, in particular, as a tool for informing clinical care and public health policy with respect to drugs. 2. A historical literature review was conducted with amalgamation and comparison of a series of published and unpublished clinical toxicology datasets from NPIS Edinburgh and other sources. 3. Clinical databases within poisons treatment centres offer an important method of collecting data on the clinical effects of drugs in overdose. These data can be used to increase knowledge on drug toxicity mechanisms that inform licensing decisions, contribute to evidence-based care and clinical management. Combination of this material with national morbidity datasets provides another valuable approach that can inform public health prevention strategies. 4. In conclusion, clinical toxicology datasets offer clinical pharmacologists a new study area. Clinical toxicology treatment units and poisons information services offer an important health resource.
Margolis, C Z
The clinical algorithm (flow chart) is a text format that is specially suited for representing a sequence of clinical decisions, for teaching clinical decision making, and for guiding patient care. A representative clinical algorithm is described in detail; five steps for writing an algorithm and seven steps for writing a set of algorithms are outlined. Five clinical education and patient care uses of algorithms are then discussed, including a map for teaching clinical decision making and protocol charts for guiding step-by-step care of specific problems. Clinical algorithms are compared as to their clinical usefulness with decision analysis. Three objections to clinical algorithms are answered, including the one that they restrict thinking. It is concluded that methods should be sought for writing clinical algorithms that represent expert consensus. A clinical algorithm could then be written for any area of medical decision making that can be standardized. Medical practice could then be taught more effectively, monitored accurately, and understood better.
Smith, R V
The education and training of clinical scientists has served society in several ways. For academic pharmacy, the emergence of clinical science has provided research and scholarship opportunities for clinical faculty development. Clinical scientists have also begun to play important roles in industrial drug research and development. For all faculty and students, clinical science research reinforces a "research mindset" that will become increasingly important as our society moves from a production/extraction to an information-based economy. Pharmacy will best evolve by increasing its commitment to clinical science research. In the process, academic pharmacy must continue to improve and support excellent education and training programs for clinical scientists.
... Work Who Can Participate What To Expect During Benefits and Risks How They Protect Participants Finding Clinical Trials Links Children & Clinical Studies NHLBI Trials Clinical Trial Websites How Do Clinical Trials Work? If you take part in a clinical trial, ...
... and treat children with arthritis, periodic fever syndromes, lupus, and other rheumatic diseases who are enrolled in clinical trials. Clinical trials may be studies of the natural history, signs, and symptoms of disease when usual treatment ...
Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.
Singer, Peter A; Pellegrino, Edmund D; Siegler, Mark
A decade ago, we reviewed the field of clinical ethics; assessed its progress in research, education, and ethics committees and consultation; and made predictions about the future of the field. In this article, we revisit clinical ethics to examine our earlier observations, highlight key developments, and discuss remaining challenges for clinical ethics, including the need to develop a global perspective on clinical ethics problems. PMID:11346456
Mosby, Margaret A.; Naisawald, Gretchen
This course text outlines the objectives and content for a professional continuing education course on clinical medical librarianship. Following an introduction to the course, the history of clinical librarianship and several programs are described. The third section offers guidelines for setting goals and objectives for a clinical librarian…
Resnik, Kenneth S; DiLeonardo, Mario; Gibbons, George
Cutaneous metastases present themselves in a variety of clinical patterns and tend to be manifested as indurated papules/nodules/tumors. Some of those clinical expressions are unique for certain types of metastases. This report describes an entirely different phenomenon of clinically incognito cutaneous metastases that were only apparent histopathologically as an incidental finding.
Pradhan, Malcolm; Liaw, Siaw Teng
This chapter gives an educational overview of: * The elements of a clinical decision; * The elements of decision making: prior probability, evidence (likelihood), posterior probability, actions, utility (value); * A framework for decision making, and support, encompassing validity, utility, importance and certainty; and * The required elements of a clinical decision support system. * The role of knowledge management in the construction and maintenance of clinical decision support.
In distant 1972, within framework of the Internal Clinic, a cardiologic department was organized which was soon, on 29.XII.1974, transformed into the Cardiology Clinic, later the Institute for Heart Diseases, and in 2008 was renamed the University Cardiology Clinic. The greater part of its foundation was possible owing to Prof. Dimitar Arsov and Prof. Radovan Percinkovski, who was the clinic's first director in the period from 1974 to 1984. In 1985, the Clinic moved into its own new building, and in that way was physically detached from the Internal Clinics. Until its move to the new building, the Clinic functioned in the Internal Clinics building, organized as an outpatient polyclinic and inpatient infirmary department with clinical beds, a coronary intensive care unit and a haemodynamics laboratory equipped with the most modern equipment of that time. Today the Clinic functions through two integral divisions: an inpatient infirmary department which comprises an intensive coronary care unit and fourteen wards which altogether have 139 clinical beds, and the diagnostic centre which comprises an emergency clinic and day hospital, a communal and consultative outpatients' clinic functioning on a daily basis, through which some 300-350 patients pass every day, and diagnostic laboratories with a capacity of nearly 100 non-invasive and 20-30 invasive diagnostic procedures daily. The Clinic is a teaching base, and its doctors are educators of students at the Medical, Dental and Pharmacy Faculties, and also of students at the High School for Nurses and X-ray technicians, but also for those in Internal Medicine and especially Cardiology. The Clinic is also a base for scientific Masters' and post-doctoral studies, and such higher degrees are achieved not only by doctors who work here, but also by doctors from Medical Centres both in the country and abroad. Doctors working in this institution publish widely, not only a great number of books and monographs, but also original
Kalra, Sanjay; Gupta, Yashdeep
This article defines and explains the concept of good clinical sense. It defines good clinical sense as "the presence of sensory faculties, their usage and interpretation, by which one is able to practice good clinical medicine". Good clinical sense differs from good clinical practice (GCP) and good clinical acumen. It encompasses all steps of the clinical, diagnostic and therapeutic process, and encourages diligent practice of clinical medicine. Good clinical sense is integral to the practice of diabetology.
This essay argues that while we have examined clinical ethics quite extensively in the literature, too little attention has been paid to the complex question of how clinical ethics is learned. Competing approaches to ethics pedagogy have relied on outmoded understandings of the way moral learning takes place in ethics. It is argued that the better approach, framed in the work of Aristotle, is the idea of phronesis, which depends on a long-term mentorship in clinical medicine for either medical students or clinical ethics students. Such an approach is articulated and defended.
--The advent of payment by results has seen the role of the clinical coder pushed to the fore in England. --Examinations for a clinical coding qualification began in 1999. In 2004, approximately 200 people took the qualification. --Trusts are attracting people to the role by offering training from scratch or through modern apprenticeships.
Margolin, David A.; Beck, David E.
A multispecialty clinic practice is a common practice arrangement for colorectal surgeons. This type of practice has a variety of features, both positive and negative. The authors explore location, practice patterns, lifestyles, compensation, and academic opportunities associated with a multispecialty clinic practice. This information can assist younger surgeons in choosing a practice opportunity and guide experienced surgeons through their career progression. PMID:22654568
Scarpa, Philip J.; Williams, Richard
NASA maintains on site occupational health clinics at all Centers and major facilities NASA maintains an on-site clinic that offers comprehensive health care to astronauts at the Johnson Space Center NASA deploys limited health care capability to space and extreme environments Focus is always on preventive health care
Evans, Scott R.
Most errors in clinical trials are a result of poor planning. Fancy statistical methods cannot rescue design flaws. Thus careful planning with clear foresight is crucial. The selection of a clinical trial design structure requires logic and creativity. Common structural designs are discussed. PMID:21423788
Summary HPP is a rare disease that manifests in different ways across the life course. Accurate diagnosis depends upon the use of appropriate age-related normative data. A new therapy is undergoing clinical trials; the preliminary published data is encouraging, but the scope of clinical application remains to be determined. PMID:26604944
Brammell, H. L.; Orr, William
The scalar electrocardiogram (ECG) is one of the most important and commonly used clinical tools in medicine. A detailed description of the recordings of cardiac electrical activity made by the ECG is presented, and the vast numbers of uses made with the data provided by this diagnostic tool are cited. Clinical applications of the ECG are listed.…
Silva, Lígia; Sampaio, Luzia; Pinto, José; Ventura, Francisco S
In front of a patient with arthritis, clinical good-sense tells that the most probable diagnosis are the most prevalent ones. Nevertheless, we have to exclude a multiplicity of other aetiologies, less frequent, but with highest implications in the therapeutic conduct. Infections by Brucella and by Borrelia are rare causes of chronic arthritis, yet are diagnosis to consider, even when the clinical manifestations aren't the most typical, as there still exist endemic areas in Portugal. Here we report two clinical cases about patients with arthritis for more than one year, subject to ineffective exams ant treatments. Only the clinical history could put on evidence clinical-epidemiological data, suggestive of Brucellosis and Lyme Disease, namely the professional contact with infected animals, and the history of probable erythema migrans, that pointed toward the correct diagnosis. So, with directed therapeutic, there was complete resolution of the inflammatory symptoms.
Sánchez-Gonzaléz, Miguel; Herreros, Benjamín
Bioethics has grown exponentially in recent decades. Its most important schools include principlism, casuistry, virtue ethics and the ethics of care. These schools are not exclusive. Within bioethics, clinical ethics addresses the inherent clinical practice ethical problems, problems which are many and very varied. Bioethics training is essential for clinicians to address these bioethics' problems. But even the professionals are trained, there are problems that cannot be solved individually and require advisory groups in clinical ethics: clinical ethics committees. These committees are also responsible for education in bioethics in health institutions. Clinical bioethics is a practical discipline, oriented to address specific problems, so its development is necessary to improve the decision making in such complex problems, inevitable problems in healthcare.
Clinical trials/research are conducted to examine the clinical questions of practicing physicians. It is important to design trials appropriately in advance, taking their feasibility into account. A randomized, controlled trial is the ultimate design for treatment comparisons at the final confirmatory stage. However, randomized trials do not necessarily provide all answers to clinical questions. This article summarizes fundamental points of clinical trial design and the important role of randomization and contrasts superiority and noninferiority trials. In addition, it focuses on propensity score matching, a useful method to compare two treatment arms, especially in the context where randomization is infeasible. The propensity score-matching method is increasingly used in surgical clinical research.
Baker, Richard; Esquenazi, Alberto; Benedetti, Maria G; Desloovere, Kaat
Gait analysis is a well-established tool for the quantitative assessment of gait disturbances providing functional diagnosis, assessment for treatment planning, and monitoring of disease progress. There is a large volume of literature on the research use of gait analysis, but evidence on its clinical routine use supports a favorable cost-benefit ratio in a limited number of conditions. Initially gait analysis was introduced to clinical practice to improve the management of children with cerebral palsy. However, there is good evidence to extend its use to patients with various upper motor neuron diseases, and to lower limb amputation. Thereby, the methodology for properly conducting and interpreting the exam is of paramount relevance. Appropriateness of gait analysis prescription and reliability of data obtained are required in the clinical environment. This paper provides an overview on guidelines for managing a clinical gait analysis service and on the principal clinical domains of its application: cerebral palsy, stroke, traumatic brain injury and lower limb amputation.
The complexity and cost of health care, along with a greater need for accountability calls for a new style of clinical leadership. The new clinical leader will lead reform by putting the needs of the patient first and foremost, looking at current and planned services from the patient's point of view as well as the clinician's. Excellent clinical skills will remain essential but will be supplemented by a focus on team work and mentoring, patient safety, clear communication and reduction in waste and inefficiency, leading to better financial outcomes. The new clinical leaders will understand the importance of consulting widely and engaging colleagues in creating change to improve patient care. They will develop trusting and mutually respectful relationships with health service management and be able to negotiate the delicate balance between clinical judgement, resource constraints and personal loyalties by keeping the best outcome for the patient at the forefront of their thinking.
Sessler, Daniel I; Imrey, Peter B
Case-control and cohort studies are invaluable research tools and provide the strongest feasible research designs for addressing some questions. Case-control studies usually involve retrospective data collection. Cohort studies can involve retrospective, ambidirectional, or prospective data collection. Observational studies are subject to errors attributable to selection bias, confounding, measurement bias, and reverse causation-in addition to errors of chance. Confounding can be statistically controlled to the extent that potential factors are known and accurately measured, but, in practice, bias and unknown confounders usually remain additional potential sources of error, often of unknown magnitude and clinical impact. Causality-the most clinically useful relation between exposure and outcome-can rarely be definitively determined from observational studies because intentional, controlled manipulations of exposures are not involved. In this article, we review several types of observational clinical research: case series, comparative case-control and cohort studies, and hybrid designs in which case-control analyses are performed on selected members of cohorts. We also discuss the analytic issues that arise when groups to be compared in an observational study, such as patients receiving different therapies, are not comparable in other respects.
Ortega Moreno, A
Clinical management (CM) as a concept includes different innovating experiences in health care services management among developed countries, which were initiated during the late eighties and the first nineties. They were mostly due to the concern that political leaders had about their financial viability. CM, as far as it is understood in Spain, is an organizing model which considers the patient as the centre of the health system. It is guided towards disease, looking for continuous assistance and facilitates an autonomous management together with decentralization at the time of taking decisions. It involves professionals whose clinical practice, based on guides, medical records and care planning, incorporate the knowledge and methodology of "evidence based medicine". Clinical management units (CMU) are organizational types of CM, which implantation is spreading rapidly in the different national health care systems. They include a person who assumes responsibility for them, who act as the hospital directorship interlocutor and are autonomous at the time of managing the allocated resources related to their medical programmes and services. They have an information system adapted to their own needs and an outcome evaluation system which allows them "process" re-engineering. CMU's strengths and weaknesses are highly dependent on the professionals that integrate them. The CMU responsible carries out a management contract with the hospital directorship in which CMU competences, directorship's obligations, essential aspects to meet agreed goals, an outcome evaluation system and an incentives scheme are included.
Rhoads, Daniel D; Sintchenko, Vitali; Rauch, Carol A; Pantanowitz, Liron
The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future.
Sintchenko, Vitali; Rauch, Carol A.; Pantanowitz, Liron
SUMMARY The clinical microbiology laboratory has responsibilities ranging from characterizing the causative agent in a patient's infection to helping detect global disease outbreaks. All of these processes are increasingly becoming partnered more intimately with informatics. Effective application of informatics tools can increase the accuracy, timeliness, and completeness of microbiology testing while decreasing the laboratory workload, which can lead to optimized laboratory workflow and decreased costs. Informatics is poised to be increasingly relevant in clinical microbiology, with the advent of total laboratory automation, complex instrument interfaces, electronic health records, clinical decision support tools, and the clinical implementation of microbial genome sequencing. This review discusses the diverse informatics aspects that are relevant to the clinical microbiology laboratory, including the following: the microbiology laboratory information system, decision support tools, expert systems, instrument interfaces, total laboratory automation, telemicrobiology, automated image analysis, nucleic acid sequence databases, electronic reporting of infectious agents to public health agencies, and disease outbreak surveillance. The breadth and utility of informatics tools used in clinical microbiology have made them indispensable to contemporary clinical and laboratory practice. Continued advances in technology and development of these informatics tools will further improve patient and public health care in the future. PMID:25278581
Rollo, David; Machado, Sanjay; Ceschin, Mauro
Clinical trial design for nuclear medicine diagnostic imaging radiopharmaceuticals must include a design for preclinical safety studies. These studies should establish that the investigational product (IP) does not have a toxic effect. As a further requirement, radiopharmaceutical clinical trials include a human study (phase 1) that provides biodistribution, pharmacokinetics, and radiation dosimetry information. These studies demonstrate to the Food and Drug Administration that the IP either meets or exceeds the toxicology and radiation exposure safety limits. Satisfying this requirement can result in the Food and Drug Administration approving the performance of late-phase (phase 2/3) clinical trials that are designed to validate the clinical efficacy of the diagnostic imaging agent in patients who have a confirmed diagnosis for the intended application. Emphasis is placed on the most typical trial design for diagnostic imaging agents that use a comparator to demonstrate that the new IP is similar in efficacy to an established standard comparator. Such trials are called equivalence, or noninferiority, trials that attempt to show that the new IP is not less effective than the comparator by more than a statistically defined amount. Importantly, the trial design must not inappropriately favor one diagnostic imaging agent over the other. Bias is avoided by the use of a core laboratory with expert physicians who are not involved in the trial for interpreting and objectively scoring the image sets obtained at the clinical trial sites. Clinical trial design must also follow Good Clinical Practice (GCP) guidelines. GCP stipulates the clinical trial process, including protocol and Case Report Form design, analyses planning, as well as analyzing and preparing interim and final clinical trial/study reports.
Stufflebeam, Steven M; Tanaka, Naoaki; Ahlfors, Seppo P
Magnetoencephalography (MEG), in which magnetic fields generated by brain activity are recorded outside of the head, is now in routine clinical practice throughout the world. MEG has become a recognized and vital part of the presurgical evaluation of patients with epilepsy and patients with brain tumors. We review investigations that show an improvement in the postsurgical outcomes of patients with epilepsy by localizing epileptic discharges. We also describe the most common clinical MEG applications that affect the management of patients, and discuss some applications that are close to having a clinical impact on patients.
Thornton, J. G.; Lilford, R. J.
An informal clinical ethics committee was set up to advise on ethical problems in prenatal diagnosis in Leeds. It was used twice in six months but was not called on again in the subsequent year, and we describe this experience. In North America similar committees are often used to advise on clinical moral dilemmas, and we review the published evidence from there and discuss some of the advantages and problems. Our committee's advice may have altered clinicians' actions considerably, but perhaps doctors in Britain are not yet ready to surrender this aspect of clinical autonomy. PMID:7549638
Kao, Chien-Huei; Gau, Meei-Ling
Midwifery is a practical facet of the health sciences that emphasizes professional competence-oriented teaching and learning. Cognitive and practical processes integrate and build midwifery student professional knowledge, attitudes, and skills. Clinical education is a teaching method and strategy used to prepare midwifery students for professional practice. Midwifery clinical teaching plans are designed using literature review, expert opinions, and student comments and determine total required hours and caseloads. Midwifery clinical teaching activities and methods promote self-reflection, childbirth education fundamentals, learning by role model observation, and learning role function through overseas observership programs. This paper discusses midwifery education dilemmas and coping methods in Taiwan.
Saleh, Maha; Kamath, Binita M; Chitayat, David
Alagille syndrome is an autosomal dominant, complex multisystem disorder characterized by the presence of three out of five major clinical criteria: cholestasis with bile duct paucity on liver biopsy, congenital cardiac defects (with particular involvement of the pulmonary arteries), posterior embryotoxon in the eye, characteristic facial features, and butterfly vertebrae. Renal and vascular abnormalities can also occur. Inter- and intrafamilial variabilities in the clinical manifestations are common. We reviewed the clinical features and management as well as the molecular basis of Alagille syndrome. PMID:27418850
Ledeboer, Nathan A.
Historically, the trend toward automation in clinical pathology laboratories has largely bypassed the clinical microbiology laboratory. In this article, we review the historical impediments to automation in the microbiology laboratory and offer insight into the reasons why we believe that we are on the cusp of a dramatic change that will sweep a wave of automation into clinical microbiology laboratories. We review the currently available specimen-processing instruments as well as the total laboratory automation solutions. Lastly, we outline the types of studies that will need to be performed to fully assess the benefits of automation in microbiology laboratories. PMID:23515547
... Development (pediatric and adult) 100 Hawkins Drive Iowa City, IA 52242-1011 (877) 686-0031 (319) 353- ... Clinic (pediatric and adult) 3901 Rainbow Blvd., Kansas City, KS 66160 (913) 588-5939 Email: astanton@kumc. ...
Kling, Vera G
Nurse educators seek innovative strategies to maximize student learning in the classroom and clinical settings. Students enrolled in a nursing leadership and management course often find they spend more clinical time observing leaders than practicing the necessary skills to lead others in the provision of nursing care. In addition, opportunities to explore the nurse educator role often do not exist in baccalaureate nursing education, despite the shortage of nurse educators. An experience was developed in a baccalaureate nursing program to give senior students, under supervision of faculty, the opportunity to lead and evaluate lower-level students providing patient care in the clinical setting and to experience the role of nursing faculty. Feedback from senior students was positive, and students noted increased proficiency in leadership ability and critical thinking. Student interest in the nurse educator role was also enhanced. Program expansion and evaluation with faculty, clinical staff, and patients are planned.
Many international guidelines for epilepsy from the countries in Europe, USA and Asia have been published since the introduction of evidence-based medicine. In Japan, the clinical guidelines for epilepsy management were published by the Japanese Society of Neurology (JSN) in 2002 and 2010. The clinical guideline for epilepsy 2010 primarily targets general practitioners treating epilepsy patients. The Japan Epilepsy Society has been publishing 16 guidelines for several topics since 2005. The clinical guideline for epilepsy 2010 recommends that carbamazepine can be regarded for new onset partial epilepsy and sodium valproate is for new onset generalized epilepsy as anti-epileptic drug (AED) monotherapy. The new AEDs received approval by the Ministry of Health, Labour and Welfare, Japan, mainly in the add-on treatment of adults with partial epilepsy. The clinical guideline for epilepsy 2010 will contribute to improvement in the management of epilepsy in Japan.
Hirst, L.W.; Laing, R.A.
This book provides the general ophthalmologist with a guide to the clinical applications of specular microscopy. Important material is included on laser injury, cataract surgery, corneal transplants, glaucoma, uveitis, and trauma.
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Lukasewicz, Carol L; Mattox, Elizabeth Andersson
Patient safety organizations and health care accreditation agencies recognize the significance of clinical alarm hazards. The Association for the Advancement of Medical Instrumentation, a nonprofit organization focused on development and use of safe and effective medical equipment, identifies alarm management as a major issue for health care organizations. ECRI Institute, a nonprofit organization that researches approaches for improving patient safety and quality of care, identifies alarm hazards as the most significant of the "Top Ten Health Technology Hazards" for 2014. A new Joint Commission National Patient Safety Goal focusing on clinical alarm safety contains new requirements for accredited hospitals to be fully implemented by 2016. Through a fictional unfolding case study, this article reviews selected contributing factors to clinical alarm hazards present in inpatient, high-acuity settings. Understanding these factors improves contributions by nurses to clinical alarm safety practice.
... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...
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In response to the article by Baum-Baicker and Sisti, I will consider the kind of wisdom involved in therapeutic listening; the role of life wisdom; and the challenge of imparting clinical wisdom to young health professionals' education.
By gaining increasing acceptance from consumers and traditional providers, retail-based convenient care clinics have moved from the innovative fringe into the mainstream of healthcare delivery. Nationwide, resourceful administrators are experimenting with retail-based delivery systems, using the clinic's unique attributes to promote wellness, expand accessibility, reduce delivery costs, and enhance brand recognition. This article takes an in-depth look at the convenient care business model, pertinent regulatory issues, and some of the associated benefits and concerns.
Tawil, Peter Z; Duggan, Derek J.; Galicia, Johnah C.
MTA has been a revolutionary material in endodontics. Since it’s introduction in the 1990’s several studies have demonstrated its use in several clinical applications. MTA has been extensively studied and is currently used for perforation repairs, apexifications, regenerative procedures, apexogenesis, pulpotomies & pulp capping. This article will review the history, composition, research findings and clinical applications of this versatile material. PMID:25821936
Those interested in developing clinical academic careers might be interested in a short animated film by Health Education England (HEE) and the National Institute for Health Research. The three-minute film, a frame from which is shown below, describes the sort of opportunities that are on offer to all professionals as part of the HEE's clinical academic careers framework. You can view the film on YouTube at tinyurl.com/pelb95c.
Tarczy-Hornoch, Peter; Shannon, Paul; Baskin, Patty; Espeseth, Miriam; Pagon, Roberta A.
GeneClinics is an online genetic information resource consisting of descriptions of specific inherited disorders (“disease profiles”) as well as information on the role of genetic testing in the diagnosis, management, and genetic counseling of patients with these inherited conditions. GeneClinics is intended to promote the use of genetic services in medical care and personal decision making by providing health care practitioners and patients with information on genetic testing for specific inherited disorders. GeneClinics is implemented as an object-oriented database containing a combination of data and semistructured text that is rendered as HTML for publishing a given “disease profile” on the Web. Content is acquired from authors via templates, converted to an XML document reflecting the underlying database schema (with tagging of embedded data), and then loaded into the database and subjected to peer review. The initial implementation of a production system and the first phase of population of the GeneClinics database content are complete. Further expansion of the content to cover more disease, significant scaling up of rate of content creation, and evaluation redesign are under way. The ultimate goal is to have an entry in GeneClinics for each entry in the GeneTests directory of medical genetics laboratories—that is, for each disease for which clinical genetic testing is available. PMID:10833163
Wermeling, D P
The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.
As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.
Clinical toxinology is the medical discipline dealing with the diagnosis, treatment and prevention of toxin diseases caused by exposure to venomous animals and poisonous animals, plants and mushrooms. Currently there is no national or international organisation accrediting or training doctors in this discipline, but the role of the IST in this area is the subject of a recently approved revised Constitution. A few courses covering some aspects of clinical toxinology exist, either with limited curricula, or with only a minor clinical focus, or with a very regional, non-global focus. The only comprehensive clinical toxinology course is the one provided in Adelaide, Australia, running regularly since 1997. This course may form the nucleus from which IST can develop a global accredited training scheme in clinical toxinology. Such a scheme will require input from diverse global regions and will be far more comprehensive and over a much longer time than the current Short Course, though may incorporate the Short Course in some way, or a derivative of it. Accreditation of medical expertise in clinical toxinology will be required at the national level and this might be accomplished by the IST working with existing national medical specialty organisations and governments, with the IST supervising the training and accreditation requirements and the national organisations providing the framework for registration of medical expertise at the local level.
Bourn, Rebecka; James, Judith A.
Purpose of review Systemic lupus erythematosus (SLE) is often preceded by immune dysregulation and clinical manifestations below the threshold for SLE classification. This review discusses current and evolving concepts about the pre-classification period of SLE, including clinical and mechanistic observations, and potential avenues for early identification and intervention. Recent findings Although incomplete lupus erythematosus (ILE) involves fewer clinical manifestations than SLE, ILE can cause organ damage and mortality. Common clinical features in ILE include antinuclear antibody seropositivity, polyarthritis, immunologic manifestations, and hematological disorders. Despite having lower disease activity and damage scores than SLE patients, ILE patients may develop pulmonary arterial hypertension or renal, neurological, or peripheral vascular damage. The recently proposed SLICC SLE classification criteria could shift the period considered “preclinical SLE”. Murine studies suggest that the balance of T helper/T regulatory cells, peroxisome proliferator-activated receptor γ activity, and plasmacytoid dendritic cell pathways may be valuable targets for early intervention. Summary Advances in our understanding of early SLE, including stages before clinical features are fully developed, will improve our ability to identify individuals at high risk of classification for potential prevention trials, provide necessary information to improve diagnostic testing, and perhaps identify novel targets for directed therapeutics in clinical SLE. PMID:26125103
Arango, Jaime; Chuck, Tina; Ellenberg, Susan S.; Foltz, Bridget; Gorman, Colleen; Hinrichs, Heidi; McHale, Susan; Merchant, Kunal; Shapley, Stephanie; Wild, Gretchen
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor’s responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions. PMID:27390628
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WEITZEL, KRISTIN W.; ELSEY, AMANDA R.; LANGAEE, TAIMOUR Y.; BURKLEY, BENJAMIN; NESSL, DAVID R.; OBENG, ANIWAA OWUSU; STALEY, BENJAMIN J.; DONG, HUI-JIA; ALLAN, ROBERT W.; LIU, J. FELIX; COOPER-DEHOFF, RHONDA M.; ANDERSON, R. DAVID; CONLON, MICHAEL; CLARE-SALZLER, MICHAEL J.; NELSON, DAVID R.; JOHNSON, JULIE A.
Current challenges exist to widespread clinical implementation of genomic medicine and pharmacogenetics. The University of Florida (UF) Health Personalized Medicine Program (PMP) is a pharmacist-led, multidisciplinary initiative created in 2011 within the UF Clinical Translational Science Institute. Initial efforts focused on pharmacogenetics, with long-term goals to include expansion to disease-risk prediction and disease stratification. Herein we describe the processes for development of the program, the challenges that were encountered and the clinical acceptance by clinicians of the genomic medicine implementation. The initial clinical implementation of the UF PMP began in June 2012 and targeted clopidogrel use and the CYP2C19 genotype in patients undergoing left heart catheterization and percutaneous-coronary intervention (PCI). After 1 year, 1,097 patients undergoing left heart catheterization were genotyped preemptively, and 291 of those underwent subsequent PCI. Genotype results were reported to the medical record for 100% of genotyped patients. Eighty patients who underwent PCI had an actionable genotype, with drug therapy changes implemented in 56 individuals. Average turnaround time from blood draw to genotype result entry in the medical record was 3.5 business days. Seven different third party payors, including Medicare, reimbursed for the test during the first month of billing, with an 85% reimbursement rate for outpatient claims that were submitted in the first month. These data highlight multiple levels of success in clinical implementation of genomic medicine. PMID:24616371
Arbekacin is a broad-spectrum aminoglycoside used to treat methicillin-resistant Staphylococcus aureus (MRSA). Arbekacin has antibacterial activities against high-level gentamicin-resistant Enterococci, multidrug-resistant Pseudomonas aeruginosa, and Acinetobacter baumannii et al. Here, we reviewed in vitro data on arbekacin in Staphylococci and Gram-negative microorganisms. We also reviewed clinical studies for clinical efficacy and microbiologic efficacy data in patients with identified MRSA and suspected MRSA infections. The overall clinical efficacy ranged from 66.7% to 89.7%. The microbiologic efficacy rate ranged from 46.2% to 83%. In comparative studies between arbekacin and glycopeptides, arbekacin was similar to other glycopeptides with respect to clinical and microbiological efficacy rates. Combination trials with other antibiotics suggest that arbekacin will be a promising strategy to control Enterococcus spp. multi-drug resistant P. aeruginosa. The major adverse reaction was nephrotoxicity/hepatotoxicity, but patients recovered from most adverse reactions without any severe complications. Based on these results, arbekacin could be a good alternative to vancomycin/teicoplanin in MRSA treatment. Finally, therapeutic drug monitoring is recommended to maximize clinical efficacy and decrease nephrotoxicity. PMID:27104010
Bradley, John S; Peacock, Georgina; Krug, Steven E; Bower, William A; Cohn, Amanda C; Meaney-Delman, Dana; Pavia, Andrew T
Anthrax is a zoonotic disease caused by Bacillus anthracis, which has multiple routes of infection in humans, manifesting in different initial presentations of disease. Because B anthracis has the potential to be used as a biological weapon and can rapidly progress to systemic anthrax with high mortality in those who are exposed and untreated, clinical guidance that can be quickly implemented must be in place before any intentional release of the agent. This document provides clinical guidance for the prophylaxis and treatment of neonates, infants, children, adolescents, and young adults up to the age of 21 (referred to as "children") in the event of a deliberate B anthracis release and offers guidance in areas where the unique characteristics of children dictate a different clinical recommendation from adults.
Jansen, T; Grabbe, S; Plewig, G
Acne is a very common dermatosis with characteristic clinical features. It is a polymorphic disease. The clinical expression ranges from non-inflammatory closed and open comedones to inflammatory papules, pustules, and nodules. Most patients have a mixture of non-inflammatory and inflammatory lesions, although some have predominantly one or the other. Acne varies in severity from a very distressing, socially disabling disorder to a state that has been regarded as physiological by some authors. The most severe forms of acne are acne fulminans and acne inversa. Although acne may occur in all age groups, it is most prevalent during adolescence. It is not known why acne subsides in most patients but persists into adulthood in some. Certain medications may be associated with provocation, perpetuation, or exacerbation of pre-existing acne or with acneiform eruptions. Acne-like disorders include rosacea, pseudofolliculitis barbae, and other conditions that share clinical features with acne.
Herreros, Benjamín; Moreno-Milán, Beatriz; Pacho-Jiménez, Eloy; Real de Asua, Diego; Roa-Castellanos, Ricardo Andrés; Valentia, Emanuele
In this article some of the most relevant terms in clinical bioethics are defined. The terms were chosen based on three criteria: impact on the most important problems in clinical bioethics, difficulty in understanding, and need to clarify their meaning. For a better understanding, the terms were grouped into 5 areas: general concepts (conflict of values, deliberation, conflict of interest, conscientious objection); justice (justice, distributive justice, models of justice, triage); clinical matters (information, competency, capability, informed consent, mature minor, coercion, secrecy, privacy, confidentiality, professional secrecy); end of life (prior instructions, limitation of therapeutic efforts, professional obstinacy, futility, palliative care, palliative sedation, principle of double effect, euthanasia, assisted suicide, persistent vegetative state, minimally conscious state, locked-in syndrome, brain death), and beginning of life (assisted reproduction, genetic counseling, preimplantation genetic diagnosis).
Billow, Richard M
I call attention to the metapsychology of sense, and the role sense plays-phenomenologically and symbolically-in the life of the clinician and the group. Each group member asserts influence in taking a role as the perceiver and the perceived, the senser and the sensed. We reach for sense, for without sense reference, we cannot grasp or even talk about psychic reality. It serves as sign and symbol, as metaphor, analogy, illustration, and model. Sense fixes experience yet may fixate experience and interfere with developing abstract thoughts. Clinical vignettes illustrate how the leader may utilize his or her particular clinical sensibility to reach the group and focus attention, to link sense to psychic qualities: to the personality of the members, the group culture and process, and the live clinical interaction.
Sautter, Robert L; Thomson, Richard B
The manner in which medical care is reimbursed in the United States has resulted in significant consolidation in the U.S. health care system. One of the consequences of this has been the development of centralized clinical microbiology laboratories that provide services to patients receiving care in multiple off-site, often remote, locations. Microbiology specimens are unique among clinical specimens in that optimal analysis may require the maintenance of viable organisms. Centralized laboratories may be located hours from patient care settings, and transport conditions need to be such that organism viability can be maintained under a variety of transport conditions. Further, since the provision of rapid results has been shown to enhance patient care, effective and timely means for generating and then reporting the results of clinical microbiology analyses must be in place. In addition, today, increasing numbers of patients are found to have infection caused by pathogens that were either very uncommon in the past or even completely unrecognized. As a result, infectious disease specialists, in particular, are more dependent than ever on access to high-quality diagnostic information from clinical microbiology laboratories. In this point-counterpoint discussion, Robert Sautter, who directs a Charlotte, NC, clinical microbiology laboratory that provides services for a 40-hospital system spread over 3 states in the southeastern United States explains how an integrated clinical microbiology laboratory service has been established in a multihospital system. Richard (Tom) Thomson of the NorthShore University HealthSystem in Evanston, IL, discusses some of the problems and pitfalls associated with large-scale laboratory consolidation.
Gale, Seth A.; Barrett, A.M.; Boeve, Bradley F.; Chatterjee, Anjan; Coslett, H. Branch; D'Esposito, Mark; Finney, Glen R.; Gitelman, Darren R.; Hart, John J.; Lerner, Alan J.; Meador, Kimford J.; Pietras, Alison C.; Voeller, Kytja S.; Kaufer, Daniel I.
Objective: To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Methods: Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Results: Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. Conclusions: We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. PMID:26163433
Hertzano, Ronna; Teplitzky, Taylor B; Eisenman, David J
The clinical evaluation of patients with tinnitus differs based on whether the tinnitus is subjective or objective. Subjective tinnitus is usually associated with a hearing loss, and therefore, the clinical evaluation is focused on an otologic and audiologic evaluation with adjunct imaging/tests as necessary. Objective tinnitus is divided into perception of an abnormal somatosound or abnormal perception of a normal somatosound. The distinction between these categories is usually possible based on a history, physical examination, and audiogram, leading to directed imaging to identify the underlying abnormality.
Pham, Phuong-Chi T; Pham, Phuong-Anh T; Pham, Son V; Pham, Phuong-Truc T; Pham, Phuong-Mai T; Pham, Phuong-Thu T
Although magnesium is involved in a wide spectrum of vital functions in normal human physiology, the significance of hypomagnesemia and necessity for its treatment are under-recognized and underappreciated in clinical practice. In the current review, we first present an overview of the clinical significance of hypomagnesemia and normal magnesium metabolism, with a focus on renal magnesium handling. Subsequently, we review the literature for both congenital and acquired hypomagnesemic conditions that affect the various steps in normal magnesium metabolism. Finally, we present an approach to the routine evaluation and suggested management of hypomagnesemia.
This overview describes antidotes, and their clinical pharmacology, that have an established significance in the currently practiced clinical toxicology because of their proven effectiveness in the treatment of serious poisonings. For the proper, efficient, and targeted use of an antidote, pharmacological knowledge is required, which is a central subject of this article. Current data from the literature are used as reference along with the accumulated experiences about possible adverse effects in order to include them in therapeutic considerations. The dosage of antidotes is the subject of several other review articles and is therefore not included in this synopsis.
Relling, Mary V.; Evans, William E.
Preface After decades of discovery, inherited variation in approximately 20 genes affecting about 80 medications has been identified as actionable in the clinic. Additional somatically acquired genomic variants direct the choice of “targeted” anticancer drugs for individual patients. Current efforts that focus on the processes required to appropriately act on pharmacogenomic variability in the clinic are systematically moving pharmacogenomics from discovery to implementation as an evidenced-based strategy for improving the use of medications, thereby providing an important cornerstone for precision medicine. PMID:26469045
When evaluating the appropriate use of new genetic tests, clinicians and health care policymakers must consider the accuracy with which a test identifies a patient’s clinical status (clinical validity) and the risks and benefits resulting from test use (clinical utility). Genetic tests in current use vary in accuracy and potential to improve health outcomes, and these test properties may be influenced by testing technology and the clinical setting in which the test is used. This unit defines clinical validity and clinical utility, provides examples, and considers the implications of these test properties for clinical practice. PMID:24763995
Background Clinical scholarship has been conceptualised and theorised in the nursing literature for over 30 years but no research has captured nurses’ clinicians’ views on how it differs or is the same as clinical expertise and clinical leadership. The aim of this study was to determine clinical nurses’ understanding of the differences and similarities between the clinical expert, clinical leader and clinical scholar. Methods A descriptive interpretative qualitative approach using semi-structured interviews with 18 practising nurses from Australia, Canada and England. The audio-taped interviews were transcribed and the text coded for emerging themes. The themes were sorted into categories of clinical expert, clinical leader and clinical scholarship as described by the participants. These themes were then compared and contrasted and the essential elements that characterise the nursing roles of the clinical expert, clinical leader and clinical scholar were identified. Results Clinical experts were seen as linking knowledge to practice with some displaying clinical leadership and scholarship. Clinical leadership is seen as a positional construct with a management emphasis. For the clinical scholar they linked theory and practice and encouraged research and dissemination of knowledge. Conclusion There are distinct markers for the roles of clinical expert, clinical leader and clinical scholar. Nurses working in one or more of these roles need to work together to improve patient care. An ‘ideal nurse’ may be a blending of all three constructs. As nursing is a practice discipline its scholarship should be predominantly based on clinical scholarship. Nurses need to be encouraged to go beyond their roles as clinical leaders and experts to use their position to challenge and change through the propagation of knowledge to their community. PMID:23587282
Hunter, Sharyn; Arthur, Carol
Graduate nurses may have knowledge and adequate clinical psychomotor skills however they have been identified as lacking the clinical reasoning skills to deliver safe, effective care suggesting contemporary educational approaches do not always facilitate the development of nursing students' clinical reasoning. While nursing literature explicates the concept of clinical reasoning and develops models that demonstrate clinical reasoning, there is very little published about nursing students and clinical reasoning during clinical placements. Semi-structured interviews were conducted with ten clinical educators to gain an understanding of how they recognised, developed and appraised nursing students' clinical reasoning while on clinical placement. This study found variability in the clinical educators' conceptualisation, recognition, and facilitation of students' clinical reasoning. Although most of the clinical educators conceptualised clinical reasoning as a process those who did not demonstrated the greatest variability in the recognition and facilitation of students' clinical reasoning. The clinical educators in this study also described being unable to adequately appraise a student's clinical reasoning during clinical placement with the use of the current performance assessment tool.
Crowell, Karen; Vardell, Emily
ClinicalAccess is a new clinical decision support tool that uses a question-and-answer format to mirror clinical decision-making strategies. The unique format of ClinicalAccess delivers concise, authoritative answers to more than 120,000 clinical questions. This column presents a review of the product, a sample search, and a comparison with other point-of-care search engines.
Perlman, Baron; Lane, Robert
Discusses issues surrounding the clinical master's degree: the belief that the only true psychologist is a PhD, public confusion between doctoral and subdoctoral psychologists, training guidelines, role responsibility, employment, licensing and competency, accreditation, and supervision. Suggests an APA sponsored conference to discuss and resolve…
Horevitz, Richard P.
Hypnosis is an increasingly popular clinical intervention. The number of training courses in hypnosis is growing each year. Research on hypnosis training appears to show that limited exposure to training, as is typical in the common 3 to 5 day format of mass training, produces limited results. Only when training is extended over time do the…
A clinical psychologist and consulting psychotherapist discusses how elements of play, inherent in the intuition required in analysis, can provide a cornerstone for serious therapeutic work. She argues that many aspects of play--its key roles in human development, individual growth, and personal creativity, among others--can help therapists and…
Jones, Karyn Dayle
In mental health, family, and community counseling settings, master's-level counselors engage in unstructured clinical interviewing to develop diagnoses based on the "Diagnostic and Statistical Manual of Mental Disorders" (4th ed., text rev.; "DSM-IV-TR"; American Psychiatric Association, 2000). Although counselors receive education about…
Logemann, Jeri A.
Recent importance placed upon efficacy research has spawned the development of the Communication Sciences and Disorders Clinical Trials Research Group (CSDRG). This group, funded by the National Institutes of Health (NIH), was organized by the American Speech Language and Hearing Association to address the need for more treatment efficacy research…
Holland, Patricia E.
Clinical supervision remained grounded in empirical inquiry as late as Morris Cogan's writings on the subject in 1973. With the acknowledgment of Thomas Kuhn's (1962) paradigm shift, educational theory and practice developed interpretive methodologies. An interpretive reflection on Cogan's rationale offers insights into the current, matured…
The UK National Health Service (NHS) Clinical Knowledge Summaries, formerly known as PRODIGY, are part of the National Library for Health and provide a source of evidence-based information and practical know-how relating to the common conditions managed in primary care.
Research on the cognitive processes used by physicians during patient care (template matching, deductive logic starting with multiple hypotheses, and algorithmic logic) is examined for its applicability to optometrists and the problem-solving strategies used by optometric students in the classroom or clinic. (Author/MSE)
Cheng, Allen C.; Currie, Bart J.; Dance, David A. B.; Funnell, Simon G. P.; Limmathurotsakul, Direk; Simpson, Andrew J. H.; Peacock, Sharon J.
Clinical definitions of melioidosis and inhalation-acquired melioidosis (Burkholderia pseudomallei infection) are described together with the evidence used to develop these definitions. Such definitions support accurate public health reporting, preparedness planning for deliberate B. pseudomallei release, design of experimental models, and categorization of naturally acquired melioidosis. PMID:23468355
Edwards, Mark J
Dystonia is a common movement disorder characterised by abnormal postures of the affected body part. It has a very varied presentation and numerous causes, and this can create difficulties with diagnosis and appropriate investigation. This article aims to provide a clinical approach to patients with dystonia, focussing on how to create a differential diagnosis and to plan rational testing.
Oleszewski, Susan C.
Elements and considerations in the provision of effective remediation for optometry students not achieving in clinical competence are discussed. Remediation of technical, cognitive, and noncognitive skills are included. A course in professional communication offered by the Pennsylvania College of Optometry is described. (MSE)
Ghrelin as a human natural hormone is involved in fundamental regulatory processes of eating and energy balance. Ghrelin signals the nutrient availability from the gastrointestinal tract to the central nervous system, up-regulates food intake and lowers energy expenditure mainly through hypothalamic mediators acting both centrally and peripherally including the gastrointestinal tract (motility, epithelium), promotes both neuro-endocrine and inflammatory signals to increase skeletal muscle growth and decrease protein breakdown, and increases lipolysis while body fat utilization is reduced. Ghrelin does more to exert its probably sentinel role around "human energy": it influences through mainly extra-hypothalamic actions the hedonic and incentive value of food, mood and anxiety, sleep-wake regulation, learning and memory, and neurogenesis. Recently numerous ghrelin gene-derived peptides were discovered, demonstrating the complexity within the ghrelin/ghrelin receptor axis. For clinical applications, not only the natural ghrelin and its slice variants, but also several modified or artificial molecules acting at ghrelin-associated receptors were and are developed. Current clinical applications are limited to clinical studies, focusing mainly on cachexia in chronic heart failure, COPD, cancer, endstage- renal-disease or cystic fibrosis, but also on frailty in elderly, gastrointestinal motility (e.g., gastroparesis, functional dyspepsia, postoperative ileus), after curative gastrectomy, anorexia nervosa, growth hormone deficient patients, alcohol craving, sleep-wake regulation (e.g. major depression), or sympathetic nervous activity in obesity. The results of completed, preliminary studies support the clinical potential of ghrelin, ghrelin gene-derived peptides, and artificial analogues, suggesting that larger clinical trials are demanded to move ghrelin towards an available and reimbursed pharmaceutical intervention.
While there is evidence in the literature measuring effective clinical teacher characteristics in traditional experiences, little is known of effective characteristics expected from clinical teachers during simulated clinical experiences. This study examined which clinical teaching behaviors and characteristics are perceived by nursing students'…
Shalita, Alan R
Acne vulgaris, the most common disease of the skin, can be manifested in a wide variety of clinical presentations. As a result of this clinical variation, there are almost as many classifications of acne as there are clinicians with particular interest in the disease. Thus acne has been classified as types I-IV, inflammatory versus noninflammatory, comedonal, comedopapular, papular, papulopustular, pustular, and "cystic" or nodular (even nodular-cystic). For those who are enamored of classification, there are subdivisions of the various categories, including "sandpaper comedones" and microcysts. There is even disagreement as to what constitutes a papule versus a nodule. The classic textbook definition of a nodule refers to lesions 1 cm or larger, but the early investigators of oral isotretinoin defined nodules as 4 mm or larger, and this definition has creeped into many texts, recently clarified by Bologna.(1)
Vaccination is regarded as one of the biggest triumphs in the history of medicine. We are living in the most successful period of vaccine development. The accumulation of multidisciplinary knowledge and the investment of massive funding have enabled the development of vaccines against many infectious diseases as well as other diseases including malignant tumors. The paradigm of clinical vaccine evaluation and licensure has also been modernized based on scientific improvements and historical experience. However, there remain a number of hurdles to overcome. Continuous efforts are focused on increasing the efficacy and reducing the risks related to vaccine use. Cutting-edge knowledge about immunology and microbiology is being rapidly translated to vaccine development. Thus, physicians and others involved in the clinical development of vaccines should have sufficient understanding of the recent developmental trends in vaccination and the diseases of interest. PMID:25648742
Theodorsson, Elvar; Magnusson, Bertil; Leito, Ivo
Clinical chemistry uses automated measurement techniques and medical knowledge in the interest of patients and healthy subjects. Automation has reduced repeatability and day-to-day variation considerably. Bias has been reduced to a lesser extent by reference measurement systems. It is vital to minimize clinically important bias, in particular bias within conglomerates of laboratories that measure samples from the same patients. Small and variable bias components will over time show random error properties and conventional random-error based methods for calculating measurement uncertainty can then be applied. The present overview of bias presents the general principles of error and uncertainty concepts, terminology and analysis, and suggests methods to minimize bias and measurement uncertainty in the interest of healthcare.
Much more is known about attitudes toward mental illness and social stigma, the viscious cycle of its consequences and how to fight the social stigma in public, but much less is known about how to combat the stigma and self stigma in clinical practice. Stigma theories have not been enough to understand the feelings and experience of people with mental illness. Conceptual framework that understands stigma as consisting of difficulties of knowledge (ignorance or misinformation), problems of attitudes (prejudice), and problems of behaviour (discrimination) have not o been enough to understand stigma dynamics in the patient therapist interaction. Understanding the psychodynamic aspects of internalized stereotype of mental illness in the patient- therapist relationship may improve our competency to deal with stigma and self stigma in clinical practice.
van Mulligen, E. M.; Stam, H.; van Ginneken, A. M.
Routine capture of patient data for a computer-based patient record system remains a subject of study. Time constraints that require fast data entry and maximal expression power are in favor of free text data entry. However, using patient data directly for decision support systems, for quality assessment, etc. requires structured data entry, which appears to be more tedious and time consuming. In this paper, a prototype clinical data entry application is described that combines free text and structured data entry in one single application and allows clinicians to smoothly switch between these two different input styles. A knowledge base involving a semantic network of clinical data entry terms and their properties and relationships is used by this application to support structured data entry. From structured data, sentences are generated and shown in a text processor together with the free text. This presentation metaphor allows for easy integrated presentation of structured data and free text. Images Figure 1 Figure 2 PMID:9929186
Dawes, R M; Faust, D; Meehl, P E
Professionals are frequently consulted to diagnose and predict human behavior; optimal treatment and planning often hinge on the consultant's judgmental accuracy. The consultant may rely on one of two contrasting approaches to decision-making--the clinical and actuarial methods. Research comparing these two approaches shows the actuarial method to be superior. Factors underlying the greater accuracy of actuarial methods, sources of resistance to the scientific findings, and the benefits of increased reliance on actuarial approaches are discussed.
The author discusses programs which were directed at the installation of photovoltaic power systems in rural health clinics. The objectives included: vaccine refrigeration; ice pack freezing; lighting; communications; medical appliances; sterilization; water purification; and income generation. The paper discusses two case histories, one in the Dominican Republic and one in Colombia. The author summarizes the results of the programs, both successes and failures, and offers an array of conclusions with regard to the implementation of future programs of this general nature.
Bonnefond, Simon; Catroux, Mélanie; Melenotte, Cléa; Karkowski, Ludovic; Rolland, Ludivine; Trouillier, Sébastien; Raffray, Loic
Abstract Actinomycosis is a rare heterogeneous anaerobic infection with misleading clinical presentations that delay diagnosis. A significant number of misdiagnosed cases have been reported in specific localizations, but studies including various forms of actinomycosis have rarely been published. We performed a multicenter retrospective chart review of laboratory-confirmed actinomycosis cases from January 2000 until January 2014. We described clinical characteristics, diagnostic procedures, differential diagnosis, and management of actinomycosis of clinical significance. Twenty-eight patients were included from 6 hospitals in France. Disease was diagnosed predominately in the abdomen/pelvis (n = 9), orocervicofacial (n = 5), cardiothoracic (n = 5), skeletal (n = 3), hematogenous (n = 3), soft tissue (n = 2), and intracranially (n = 1). Four patients (14%) were immunocompromised. In most cases (92 %), the diagnosis of actinomycosis was not suspected on admission, as clinical features were not specific. Diagnosis was obtained from either microbiology (50%, n = 14) or histopathology (42%, n = 12), or from both methods (7%, n = 2). Surgical biopsy was needed for definite diagnosis in 71% of cases (n = 20). Coinfection was found in 13 patients (46%), among which 3 patients were diagnosed from histologic criteria only. Two-thirds of patients were treated with amoxicillin. Median duration of antibiotics was 120 days (interquartile range 60–180), whereas the median follow-up time was 12 months (interquartile range 5.25–18). Two patients died. This study highlights the distinct and miscellaneous patterns of actinomycosis to prompt accurate diagnosis and earlier treatments, thus improving the outcome. Surgical biopsy should be performed when possible while raising histologist's and microbiologist's awareness of possible actinomycosis to enhance the chance of diagnosis and use specific molecular methods. PMID:27311002
Arousal Correlates of Psycho- therapy and Behavior Treatment. (0) 26 1981 Environmental Stress and Electromyographic Correlates of Chronic Posterior Trunk...Studies. Univ of North Carolina at Chapel Hill, Vol 2, Jun 1981. ACCEPTED Armstrong, R.D.: Stress in the Military Family. Accepted by Fan Prac J. DENTAL...Chief Clinical Management Conference, Ft Sam Houston, TX, Jan 1981. DEPARTMENT OF PSYCHIATRY & NEUROLOGY Armitage, D.T.: Physical Activity and Stress
Lavori, Philip W.
Whereas the 20th-century health care system sometimes seemed to be inhospitable to and unmoved by experimental research, its inefficiency and unaffordability have led to reforms that foreshadow a new health care system. We point out certain opportunities and transformational needs for innovations in study design offered by the 21st-century health care system, and describe some innovative clinical trial designs and novel design methods to address these needs and challenges. PMID:26140056
This paper gives an overview on current clinical high resolution multiphoton fluorescence lifetime imaging in volunteers and patients. Fluorescence lifetime imaging (FLIM) in Life Sciences was introduced in Jena/Germany in 1988/89 based on a ZEISS confocal picosecond dye laser scanning microscope equipped with a single photon counting unit. The porphyrin distribution in living cells and living tumor-bearing mice was studied with high spatial, temporal, and spectral resolution. Ten years later, time-gated cameras were employed to detect dental caries in volunteers based on one-photon excitation of autofluorescent bacteria with long fluorescence lifetimes. Nowadays, one-photon FLIM based on picosecond VIS laser diodes are used to study ocular diseases in humans. Already one decade ago, first clinical twophoton FLIM images in humans were taken with the certified clinical multiphoton femtosecond laser tomograph DermaInspectTM. Multiphoton tomographs with FLIM modules are now operating in hospitals at Brisbane, Tokyo, Berlin, Paris, London, Modena and other European cities. Multiple FLIM detectors allow spectral FLIM with a temporal resolution down to 20 ps (MCP) / 250 ps (PMT) and a spectral resolution of 10 nm. Major FLIM applications include the detection of intradermal sunscreen and tattoo nanoparticles, the detection of different melanin types, the early diagnosis of dermatitis and malignant melanoma, as well as the measurement of therapeutic effects in pateints suffering from dermatitis. So far, more than 1,000 patients and volunteers have been investigated with the clinical multiphoton FLIM tomographs DermaInspectTM and MPTflexTM.
Annema, Jouke T; Vogiatzis, Ioannis; Grgic, Aleksander; Antoniou, Katerina; Ställberg, Björn; Herth, Felix F
This article contains highlights and a selection of the scientific advances from the Clinical Assembly that were presented at the 2015 European Respiratory Society International Congress in Amsterdam, the Netherlands. The most relevant topics for clinicians will be discussed, covering a wide range of areas including interventional pulmonology, rehabilitation and chronic care, thoracic imaging, diffuse and parenchymal lung diseases, and general practice and primary care. In this comprehensive review, exciting novel data will be discussed and put into perspective.
Patsalos, Philip N
Since 1989, eight new antiepileptic drugs (AEDs) have been licensed for clinical use. Levetiracetam is the latest to be licensed and is used as adjunctive therapy for the treatment of adult patients with partial seizures with or without secondary generalisation that are refractory to other established first-line AEDs. Pharmacokinetic studies of levetiracetam have been conducted in healthy volunteers, in adults, children and elderly patients with epilepsy, and in patients with renal and hepatic impairment. After oral ingestion, levetiracetam is rapidly absorbed, with peak concentration occurring after 1.3 hours, and its bioavailability is >95%. Co-ingestion of food slows the rate but not the extent of absorption. Levetiracetam is not bound to plasma proteins and has a volume of distribution of 0.5-0.7 L/kg. Plasma concentrations increase in proportion to dose over the clinically relevant dose range (500-5000 mg) and there is no evidence of accumulation during multiple administration. Steady-state blood concentrations are achieved within 24-48 hours. The elimination half-life in adult volunteers, adults with epilepsy, children with epilepsy and elderly volunteers is 6-8, 6-8, 5-7 and 10-11 hours, respectively. Approximately 34% of a levetiracetam dose is metabolised and 66% is excreted in urine unmetabolised; however, the metabolism is not hepatic but occurs primarily in blood by hydrolysis. Autoinduction is not a feature. As clearance is renal in nature it is directly dependent on creatinine clearance. Consequently, dosage adjustments are necessary for patients with moderate to severe renal impairment. To date, no clinically relevant pharmacokinetic interactions between AEDs and levetiracetam have been identified. Similarly, levetiracetam does not interact with digoxin, warfarin and the low-dose contraceptive pill; however, adverse pharmacodynamic interactions with carbamazepine and topiramate have been demonstrated. Overall, the pharmacokinetic characteristics of
Vogiatzis, Ioannis; Grgic, Aleksander; Antoniou, Katerina; Ställberg, Björn; Herth, Felix F.
This article contains highlights and a selection of the scientific advances from the Clinical Assembly that were presented at the 2015 European Respiratory Society International Congress in Amsterdam, the Netherlands. The most relevant topics for clinicians will be discussed, covering a wide range of areas including interventional pulmonology, rehabilitation and chronic care, thoracic imaging, diffuse and parenchymal lung diseases, and general practice and primary care. In this comprehensive review, exciting novel data will be discussed and put into perspective. PMID:27730202
Vleugels, A M
Clinical practice guidelines are systematically developed statements that are intended to support medical decision making in well-defined clinical situations. Essentially, their object is to reduce the variability in medical practice, to improve quality, and to make appropriated control of the financial resources possible. Internationally, ever more organisations, associations, and institutions are concerned with the development of guidelines in many different areas of care. Making implicit knowledge explicit is one of the associated advantages of guidelines: they have a potential utility in training, in process evaluation, and in the reevaluation of outcome studies. In liability issues, their existence has a double effect: they can be used to justify medical behaviour, and they constitute a generally accepted reference point. A derivative problem is the legal liability of the compilers of the guidelines. The principle of the guideline approach can be challenged academically: science cannot give a definition of optimal care with absolute certainty. What is called objectivity often rests on methodologically disputable analyses; also the opinion of opinion leaders is not always a guarantee for scientific soundness. Moreover, patients are not all identical: biological variability, situational factors, patient expectations, and other elements play a role in this differentiation. Clinicians are often hesitant with respect to clinical guidelines: they are afraid of cookbook medicine and curtailment of their professional autonomy. Patients fear reduction of individualization of care and the use of guidelines as a rationing instrument. The effects of the introduction of clinical practice guidelines on medical practice, on the results and on the cost of care vary but are generally considered to be favourable. The choice of appropriate strategies in development, dissemination, and implementation turns out to be of critical importance. The article ends with concrete
Exposure to plants is very common, through leisure or professional activity. In addition, plant products and botanic extracts are increasingly present in the environment. Cutaneous adverse reactions to plants and their derivatives occur fairly frequently, and establishing the correct diagnosis is not always easy. The astute clinician relies on a detailed history and a careful skin examination to substantiate his opinion. This article reviews the characteristic clinical patterns of phyto- and phytophotodermatitis and some less common presentations.
In recent years the ability of neuroscience to identify and intervene in mental functions has progressed immensely, which raises several anthropologic and ethical questions. Meanwhile neuroethics arose as a new interdisciplinary field for critical analysis of neuroscientific actions and ethical reflection on the increasing knowledge of the human brain, with regard to society and politics. This article provides a survey of neuroethical implications for clinical practice.
Chinen, Javier; Shearer, William T.
Progress in immunology continues to grow exponentially every year. New applications of this knowledge are being developed for a broad range of clinical conditions. Conversely, the study of primary and secondary immunodeficiencies is helping to elucidate the intricate mechanisms of the immune system. We have selected a few of the most significant contributions to the fields of basic and clinical immunology published between October 2001 and October 2002. Our choice of topics in basic immunology included the description of T-bet as a determinant factor for T(H)1 differentiation, the role of the activation-induced cytosine deaminase gene in B-cell development, the characterization of CD4(+)CD25(+) regulatory T cells, and the use of dynamic imaging to study MHC class II transport and T-cell and dendritic cell membrane interactions. Articles related to clinical immunology that were selected for review include the description of immunodeficiency caused by caspase 8 deficiency; a case series report on X-linked agammaglobulinemia; the mechanism of action, efficacy, and complications of intravenous immunoglobulin; mechanisms of autoimmunity diseases; and advances in HIV pathogenesis and vaccine development. We also reviewed two articles that explore the possible alterations of the immune system caused by spaceflights, a new field with increasing importance as human space expeditions become a reality in the 21st century.
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: 4'-Thio-ara-C, 5-methyltetrahydrofolate; ABT-089, AD-237, AF-37702, alvocidib hydrochloride, apricitabine, armodafinil, atrasentan, AVE-5883, avian influenza vaccine, azimilide hydrochloride; Banoxantrone, BIBF-1120; CD34+ cells, certolizumab pegol, CHIR-258, cilansetron, CoFactor, CX-3543, cystemustine; D-003, dexloxiglumide, DMXB-anabaseine; Ecogramostim, elcometrine, elcometrine/ethinylestradiol, etravirine; Fenretinide, fingolimod hydrochloride, fospropofol disodium; Gaboxadol, gestodene, glutamine; Human insulin, hyaluronic acid; Incyclinide, indacaterol, ispronicline, istradefylline; Labradimil, lamifiban, lapatinib, L-arginine hydrochloride, liposomal cisplatin, liposome encapsulated paclitaxel, LY-517717; Manidipine hydrochloride/delapril hydrochloride, maraviroc, MBP(82-98), MD-0727, MDX-214, melanotan I, MMR vaccine; Nacystelyn, nalfurafine hydrochloride, nibentan, nilotinib, NK-105; OBI-1, oblimersen sodium, olmesartan medoxomil, olmesartan medoxomil/hydrochlorothiazide, oregovomab; Pexelizumab, PG-116800, PG-CPT, PHA-794428, prasugrel; RC-3095, rDNA insulin, RFB4(dsFv)-PE38, rhEndostatin, rhenium Re-186 etidronate, rhGM-CSF, roflumilast, romidepsin; Sarcosine, SGLU1, SGN-40, succinobucol; TAU, teduglutide, telatinib, tesofensine, tipifarnib, tirapazamine, TKA-731, tolvaptan, trabectedin; Vaccimel, vatalanib succinate, velafermin, vildagliptin, vinflunine; XP-19986; YM-155.
Zhang, Xiao-Ying; Zhang, Peiying
The telemedicine department of a hospital is an emerging branch in upcoming hospitals and may become an essential component of every hospital. It basically utilizes the information technologies along with telecommunication systems in order to provide clinical care and assistance. Furthermore, the branch of telemedicine offers significant opportunities for the process of developmental freedom from illness, early death, and preventable diseases. It advances development by providing relevant drugs and the necessary care aimed to alleviate patient suffering. It is also beneficial for patients in rural remote areas who usually do not have adequate access to advanced hospitals. Telemedicine in these remote areas allows for timely treatment of emergency cases. Thus, it contributes towards remote emergency critical care in order to save lives in crucial cases. Additionally, the emerging advances have now enabled telemedicine to transfer large amounts of clinical informatics data including images, and test reports to the specifically specialized health professionals in some serious cases. However, as in the case of many emerging technologies, organizing information and understanding the field has significant challenges. The present review article aimed to discuss important aspects of the field with regard to the better management of patients in clinical settings. PMID:27703503
Grace-Farfaglia, P; Rosow, P
A review of commonly used charting formats discussed in the dietetics literature revealed that the subjective, objective assessment and planning (SOAP) approach is most frequently used by dietitians. Formats reported in the nursing literature were charting by exception (CBE); problem, intervention, evaluation (PIE); and focus/data, action, response (Focus/DAR). The strengths and weaknesses of the charting styles as they apply to the needs of clinical dietetic specialists were reviewed. We then decided to test in house the Focus/DAR format by assessing chart entries for adherence to style, brevity, and physician response. Dietitians pilot tested all the methods, but found them time consuming to use. The consensus was that SOAP could be adapted to the documentation needs of the individual situation and required little additional staff training. Often because of time limitations, a narrative summary was most appropriate. Chart entry length was reduced as much as 200% when staff were given brief clinical communication as a goal, and a further reduction when line limits were imposed. The physician response was positive, with recommendations followed in 50% of charts, compared with 34% in a previous audit. A nutrition documentation system was developed by the researchers by reviewing medical chart structure, documentation standards, methods of risk identification, and terminology for clinical documentation style. The resulting system affected the decision making of physicians, who could now scan notes more quickly and implement nutrition recommendations in a more timely fashion.
Sinagra, Gianfranco; Anzini, Marco; Pereira, Naveen L; Bussani, Rossana; Finocchiaro, Gherardo; Bartunek, Jozef; Merlo, Marco
Myocarditis is a polymorphic disease characterized by great variability in clinical presentation and evolution. Patients presenting with severe left ventricular dysfunction and life-threatening arrhythmias represent a demanding challenge for the clinician. Modern techniques of cardiovascular imaging and the exhaustive molecular evaluation of the myocardium with endomyocardial biopsy have provided valuable insight into the pathophysiology of this disease, and several clinical registries have unraveled the disease's long-term evolution and prognosis. However, uncertainties persist in crucial practical issues in the management of patients. This article critically reviews current information for evidence-based management, offering a rational and practical approach to patients with myocarditis. For this review, we searched the PubMed and MEDLINE databases for articles published from January 1, 1980, through December 31, 2015, using the following terms: myocarditis, inflammatory cardiomyopathy, and endomyocardial biopsy. Articles were selected for inclusion if they represented primary data or were review articles published in high-impact journals. In particular, a risk-oriented approach is proposed. The different patterns of presentation of myocarditis are classified as low-, intermediate-, and high-risk syndromes according to the most recent evidence on prognosis, clinical findings, and both invasive and noninvasive testing, and appropriate management strategies are proposed for each risk class.
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses, which has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, providing information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abacavir sulfate; abciximab; abetimus sodium; adalimumab; aldesleukin; almotriptan; alteplase; amisulpride; amitriptyline hydrochloride; amoxicillin trihydrate; atenolol; atorvastatin calcium; atrasentan; Beclometasone dipropionate; bosentan; Captopril; ceftriaxone sodium; cerivastatin sodium; cetirizine hydrochloride; cisplatin; citalopram hydrobromide; Dalteparin sodium; darusentan; desirudin; digoxin; Efalizumab; enoxaparin sodium; ertapenem sodium; esomeprazole magnesium; estradiol; ezetimibe; Famotidine; farglitazar; fluorouracil; fluticasone propionate; fosamprenavir sodium; Glibenclamide; glucosamine sulfate; Heparin sodium; HSPPC-96; hydrochlorothiazide; Imatinib mesilate; implitapide; Lamivudine; lansoprazole; lisinopril; losartan potassium; l-Propionylcarnitine; Melagatran; metformin hydrochloride; methotrexate; methylsulfinylwarfarin; Nateglinide; norethisterone; Olmesartan medoxomil; omalizumab; omapatrilat; omeprazole; oseltamivir phosphate; oxatomide; Pantoprazole; piperacillin sodium; pravastatin sodium; Quetiapine hydrochloride; Rabeprazole sodium; raloxifene hydrochloride; ramosetron hydrochloride; ranolazine; rasburicase; reboxetine mesilate; recombinant somatropin; repaglinide; reteplase; rosiglitazone; rosiglitazone maleate; rosuvastatin calcium; Sertraline; simvastatin; sumatriptan succinate; Tazobactam sodium; tenecteplase; tibolone; tinidazole; tolterodine tartrate; troglitazone; Uniprost; Warfarin sodium; Ximelagatran.
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables can be retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: Abacavir sulfate, abarelix, abciximab, acarbose, alefacept, alteplase, amisulpride, amoxicillin trihydrate, apomorphine hydrochloride, aprepitant, argatroban monohydrate, aspirin, atenolol; Betamethasone dipropionate, betamethasone valerate, bicalutamide, bleomycin sulfate; Calcium carbonate, candesartan cilexetil, celecoxib, cetirizine hydrochloride, cisplatin, clarithromycin, clavulanate potassium, clomethiazole edisilate, clopidogrel hydrogensulfate, cyclophosphamide, chorionic gonadotropin (human); Dalteparin sodium, desloratadine, dexamethasone, doxorubicin, DPC-083; Efalizumab, efavirenz, enoxaparin sodium, eprosartan mesilate, etanercept, etoposide, ezetimibe; Faropenem daloxate, fenofibrate, fluocinolone acetonide, flutamide, fluvastatin sodium, follitropin beta, fondaparinux sodium; Gabapentin, glibenclamide, goserelin, granisetron hydrochloride; Haloperidol, hydrochlorothiazide; Imiquimod, interferon beta-1a, irbesartan, iseganan hydrochloride; L-758298, lamivudine, lanoteplase, leflunomide, leuprorelin acetate, loratadine, losartan potassium; Melagatran, metformin hydrochloride, methotrexate, metronidazole, micafungin sodium, mitoxantrone hydrochloride; Nelfinavir mesilate, neutral insulin injection, nizatidine; Olopatadine hydrochloride, omeprazole, ondansetron hydrochloride; Pamidronate sodium, paracetamol, paroxetine hydrochloride, perindopril, pimecrolimus, pioglitazone hydrochloride, piroxicam, pleconaril, pralmorelin, pravastatin sodium, prednisolone, prednisone, propofol; Raloxifene hydrochloride, ranpirnase, remifentanil hydrochloride, risedronate sodium, risperidone, rofecoxib, ropinirole
Summary Objectives To provide an overview of the benefits of clinical data collected as a by-product of the care process, the potential problems with large aggregations of these data, the policy frameworks that have been formulated, and the major challenges in the coming years. Methods This report summarizes some of the major observations from AMIA and IMIA conferences held on this admittedly broad topic from 2006 through 2013. This report also includes many unsupported opinions of the author. Results The benefits of aggregating larger and larger sets of routinely collected clinical data are well documented and of great societal benefit. These large data sets will probably never answer all possible clinical questions for methodological reasons. Non-traditional sources of health data that are patient-sources will pose new data science challenges. Conclusions If we ever hope to have tools that can rapidly provide evidence for daily practice of medicine we need a science of health data perhaps modeled after the science of astronomy. PMID:25123722
Salcman, M; Samaras, G M
Modern technology has profoundly altered the clinical practice of neurosurgery. For a wide variety of conditions, patients are being implanted with active and passive devices or treated with advanced microsurgical instrumentation. After surgery, such patients are sent to modern intensive-care units employing the latest advances in patient monitoring and computer technology. We contend that the responsibilities of the Clinical Engineer extend beyond simple installation and maintenance of equipment and systems. It is essential that he take part in the continuing education of non-technical personnel who must make use of the equipment in ways that are meaningful in the care of the patient and to the progress of clinical science. This point is illustrated by our experience with a neurosurgical intensive-care unit. It is also the thesis of this paper that the design and maintenance of increasingly sophisticated biomedical systems will benefit from the use of an interdisciplinary approach at the very inception of a project. This approach is illustrated by our current development of a multibeam microwave hyperthermia system for possible use in the treatment of brain tumors.
Chen, Xiao-He; Huang, Shuwen; Kerr, David
Biomarkers have been used in clinical medicine for decades. With the rise of genomics and other advances in molecular biology, biomarker studies have entered a whole new era and hold promise for early diagnosis and effective treatment of many diseases. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a therapeutic intervention (1). They can be classified into five categories based on their application in different disease stages: 1) antecedent biomarkers to identify the risk of developing an illness, 2) screening biomarkers to screen for subclinical disease, 3) diagnostic biomarkers to recognize overt disease, 4) staging biomarkers to categorise disease severity, and 5) prognostic biomarkers to predict future disease course, including recurrence, response to therapy, and monitoring efficacy of therapy (1). Biomarkers can indicate a variety of health or disease characteristics, including the level or type of exposure to an environmental factor, genetic susceptibility, genetic responses to environmental exposures, markers of subclinical or clinical disease, or indicators of response to therapy. This chapter will focus on how these biomarkers have been used in preventive medicine, diagnostics, therapeutics and prognostics, as well as public health and their current status in clinical practice.
Friedman, C P
The increased use of community sites for the clinical training of medical students creates many challenges for educators. Among them is the need to provide students in community settings with access to the same range of educational resources-the medical literature, student colleagues, feedback, and faculty-that are customarily available at academic medical centers. One way to make this access possible is to use information technology to create a "virtual clinical campus," which would allow students to enjoy the best of both worlds: the immersion in primary care offered by the community-based setting and the knowledge-rich resources of the academic medical center, including the all-important library. With a virtual campus in place, students would be able to access most library resources, interact with their peers, ensure that they were meeting the goals of their community rotations, and participate with their colleagues in didactic sessions without having to travel. The virtual campus is technologically feasible and economically within reach. It is possible that the movement of clinical training into the community will make it imperative for all medical students to own their own computers and for medical centers to provide the infrastructure that would enable community sites to have access to a range of educational resources.
Briggs, R; Robinson, S; O'Neill, D
Despite being the most significant consumers of health care resources and medications worldwide, recent international research has highlighted the under-representation of older participants from clinical trials. This creates problems for physicians as the patients seen in clinical practice are not representative of those on which medical treatments and interventions have been trialled, and we need to consider whether results (both negative and positive) from these trials are applicable to these patients. Our aim was to gauge whether exclusion of older people was prevalent in research proposals submitted to Dublin teaching hospitals. We audited all clinical research proposals submitted to the Research Ethics committee (REC) covering the teaching hospitals attached to Trinity College Dublin (TCD) from July 2008 to July 2011 inclusive, recording exclusion of patients based on an arbitrary upper age limit. Of the 226 relevant trials studied, 31(13.7%) excluded participants based solely on an arbitrary upper age limit. 22 (9.8%) of the relevant trials were submitted by geriatricians, none of which excluded patients based solely on age. Over 50% (12 of 22) trials submitted by neurology/psychiatry excluded patients based on an upper age limit. The mean upper age limit used over all trials as a cut-off was 69.2 years of age. As well as this, the majority of the remaining trials also contained other exclusion criteria, especially those based on cognitive function which further limited participation of older people. While we found that a significant proportion of clinical trials submitted to the TCD REC still excluded patients based arbitrarily on an upper age limit, participation rates of older people seem to be higher in this Irish centre than that seen in international trials. Significant room for improvement still remains however and there needs to be a promotion of greater awareness of the need for developing, testing and licensing medicines so that it mirrors the
Egan, Tony; Jaye, Chrystal
The social organization of clinical learning is under-theorized in the sociological literature on the social organization of health care. Professional scopes of practice and jurisdictions are formally defined by professional principles and standards and reflected in legislation; however, these are mediated through the day-to-day clinical activities of social groupings of clinical teams. The activities of health service providers typically occur within communities of clinical practice. These are also major sites for clinical curriculum delivery, where clinical students learn not only clinical skills but also how to be health professionals. In this article, we apply Wenger's model of social learning within organizations to curriculum delivery within a health service setting. Here, social participation is the basis of learning. We suggest that it offers a powerful framework for recognizing and explaining paradox and incongruence in clinical teaching and learning, and also for recognizing opportunities, and devising means, to add value to students' learning experiences.
O'Hara, Ruth; Beaudreau, Sherry A; Gould, Christine E; Froehlich, Wendy; Kraemer, Helena C
The purpose of this paper is to a) outline the importance of including patients with clinical comorbidities in Randomized Clinical Trials (RCTs) of psychiatric treatments; and b) to propose a specific approach for best handling, analyzing and interpreting the data on clinical comorbidities in terms of their impact on treatment outcomes. To do this we first define and describe clinical comorbidity and differentiate it from other forms of comorbidity. We then describe the methodological and analytical problems associated with excluding patients with clinically comorbid conditions from RCTs, including the impact on the outcomes of RCTs in psychiatry and the impact on evidence-based clinical decision-making. We then address the challenges inherent to including patients with clinical comorbidities in RCTs. Finally, we propose a methodological and analytic approach to deal with these issues in RCTs which aims to significantly improve the information yielded from RCTs in psychiatry, and thus improve clinical decision-making.
The NCI’s Division of Cancer Treatment and Diagnosis and the Cancer Diagnosis Program announce a request for applications for the Clinical Assay Development Program (CADP) for investigators seeking clinical assay development and validation resources.
Kim, Sollip; Yun, Yeo-Min; Chae, Hyo-Jin; Cho, Hyun-Jung; Ji, Misuk; Kim, In-Suk; Wee, Kyung-A; Lee, Woochang; Song, Sang Hoon; Woo, Hye In
Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings. PMID:28029011
Kim, Sollip; Yun, Yeo Min; Chae, Hyo Jin; Cho, Hyun Jung; Ji, Misuk; Kim, In Suk; Wee, Kyung A; Lee, Woochang; Song, Sang Hoon; Woo, Hye In; Lee, Soo Youn; Chun, Sail
Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.
Borleffs, Jan C. C.; Custers, Eugene J. F. M.; van Gijn, Jan; ten Gate, Olle Th. J.
Describes a new approach to clinical reasoning education called clinical reasoning theater (CRT). With students as the audience, the doctor's clinical reasoning skills are modeled in CRT when he or she thinks aloud during conversations with the patient. Preliminary results of students' evaluations of the relevance of CRT reveal that they…
Lajoie, Travis; Sonkiss, Joshua; Rich, Anne
Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…
Moral, M A; Tomillero, A
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 131-I-Chlorotoxin, 423557; Abatacept, Ad.Egr.TNF.11D, Adalimumab, AE-941, Ambrisentan, AMR-001, Anacetrapib, Anakinra, Aripiprazole, Atazanavir sulfate; BAY-639044, Bazedoxifene acetate, Belimumab, Bevacizumab, Bortezomib, Botulinum toxin type B, Brivaracetam, Bucindolol hydrochloride; Carfilzomib, Carisbamate, CCX-282, CD20Bi, Ceftobiprole, Certolizumab pegol, CF-101, Cinacalcet hydrochloride, Cypher; Darifenacin hydrobromide, Degarelix acetate, Denosumab, Desvenlafaxine succinate, Dexlansoprazole, Dexverapamil, Drotrecogin alfa (activated), Duloxetine hydrochloride, Dutasteride; Efalizumab, EPs-7630, Escitalopram oxalate, Etoricoxib; Fluticasone furoate, Fondaparinux sodium, Fospropofol disodium; Hexadecyloxypropyl-cidofovir, HIV gp120/NefTat/AS02A, HPV-6/11/16/18; INCB-18424, Incyclinide, Inhalable human insulin, Insulin detemir; KNS-760704, KW-0761; Lacosamide, Lenalidomide, Levetiracetam, Licofelone, Lidocaine/prilocaine; mAb 216, MEDI-528, Men ACWY, Meningococcal C-CRM197 vaccine, Methylnaltrexone bromide; Nemifitide ditriflutate, Nicotine conjugate vaccine, Nilotinib hydrochloride monohydrate; Octaparin; Parathyroid hormone (human recombinant), Pegaptanib octasodium, Pitrakinra, Prasterone, Pregabalin; Ranelic acid distrontium salt, Rasagiline mesilate, Retigabine, Rimonabant, RTS,S/AS02D; Sarcosine, Sitaxentan sodium, Solifenacin succinate, Sunitinib malate; Taranabant, Taxus, Teduglutide, Teriparatide, Ticagrelor, Travoprost, TRU-015; USlipristal acetate, Urocortin 2; Vardenafil hydrochloride hydrate; YM-155, Yttrium 90 (90Y) ibritumomab tiuxetan; Zanolimumab, Zoledronic acid monohydrate, Zotarolimus
Hyponatremia is the most frequent electrolyte disorder and the syndrome of inappropriate antidiuretic hormone secretion (SIADH) accounts for approximately one-third of all cases. In the diagnosis of SIADH it is important to ascertain the euvolemic state of extracellular fluid volume, both clinically and by laboratory measurements. SIADH should be treated to cure symptoms. While this is undisputed in the presence of grave or advanced symptoms, the clinical role and the indications for treatment in the presence of mild to moderate symptoms are currently unclear. Therapeutic modalities include nonspecific measures and means (fluid restriction, hypertonic saline, urea, demeclocycline), with fluid restriction and hypertonic saline commonly used. Recently vasopressin receptor antagonists, called vaptans, have been introduced as specific and direct therapy of SIADH. Although clinical experience with vaptans is limited at this time, they appear advantageous to patients because there is no need for fluid restriction and the correction of hyponatremia can be achieved comfortably and within a short time. Vaptans also appear to be beneficial for physicians and staff because of their efficiency and reliability. The side effects are thirst, polydipsia and frequency of urination. In any therapy of chronic SIADH it is important to limit the daily increase of serum sodium to less than 8–10 mmol/liter because higher correction rates have been associated with osmotic demyelination. In the case of vaptan treatment, the first 24 h are critical for prevention of an overly rapid correction of hyponatremia and the serum sodium should be measured after 0, 6, 24 and 48 h of treatment. Discontinuation of any vaptan therapy for longer than 5 or 6 days should be monitored to prevent hyponatremic relapse. It may be necessary to taper the vaptan dose or restrict fluid intake or both. PMID:23148195
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the world's first drug discovery and development portal, and provides information on study design, treatments, conclusions and references. This issue focuses on the following selection of drugs: Abiciximab, acetylcholine chloride, acetylcysteine, alefacept, alemtuzumab, alicaforsen, alteplase, aminopterin, amoxicillin sodium, amphotericin B, anastrozole, argatroban monohydrate, arsenic trioxide, aspirin, atazanavir, atorvastatin, augmerosen, azathioprine; Benzylpenicillin, BMS-284756, botulinum toxin type A, botulinum toxin type B, BQ-123, budesonide, BXT-51072; Calcium folinate, carbamazepine, carboplatin, carmustine, ceftriaxone sodium, cefuroxime axetil, chorionic gonadotropin (human), cimetidine, ciprofloxacin hydrochloride, cisplatin, citalopram hydrobromide, cladribine, clarithromycin, clavulanic acid, clofarabine, clopidogrel hydrogensulfate, clotrimazole, CNI-1493, colesevelam hydrochloride, cyclophosphamide, cytarabine; Dalteparin sodium, daptomycin, darbepoetin alfa, debrisoquine sulfate, dexrazoxane, diaziquone, didanosine, docetaxel, donezepil, doxorubicin hydrochloride liposome injection, DX-9065a; Eberconazole, ecogramostim, eletriptan, enoxaparin sodium, epoetin, epoprostenol sodium, erlizumab, ertapenem sodium, ezetimibe; Fampridine, fenofibrate, filgrastim, fluconazole, fludarabine phosphate, fluorouracil, 5-fluorouracil/epinephrine, fondaparinux sodium, formoterol fumarate; Gabapentin, gemcitabine, gemfibrozil, glatiramer; Heparin sodium, homoharringtonine; Ibuprofen, iloprost, imatinib mesilate, imiquimod, interferon alpha-2b, interferon alpha-2c, interferon-beta; KW-6002; Lamotrigine, lanoteplase, metoprolol tartrate, mitoxantrone hydrochloride; Naproxen sodium, naratriptan, Natalizumab, nelfinavir mesilate
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 5-Methyltetrahydrofolate, 9-aminocamptothecin; AdPEDF.11, AE-37, albumin interferon alfa, alicaforsen sodium, alvocidib hydrochloride, AMG-706, arginine butyrate, avanafil, axitinib, azimilide hydrochloride; BAY-579352, belagenpumatucel-L, beta-lapachone, BHT-3009, BIBW-2992, bremelanotide, BX-471; Casopitant mesylate, cediranib, certolizumab pegol, CH-1504, ChimeriVax-West Nile, clofazimine, CpG-7909, curcumin, Cypher; Dapoxetine hydrochloride, darusentan, diflomotecan, D-methionine, dnaJP1, D-serine, DTPw-HB Hib-MenAC, DTPw-HepB-Hib; E-7010, ecogramostim, edodekin alfa, EGFRvlll peptide vaccine, elcometrine, elcometrine/ethinylestradiol, elsilimomab, enrasentan, ertumaxomab, etalocib sodium, exisulind; Fenretinide, fesoterodine, fingolimod hydrochloride, fontolizumab; Gefitinib, gemtuzumab ozogamicin, ghrelin (human), GV-1001; HTU-PA, human papillomavirus vaccine; Indacaterol, indiplon, interleukin-21, intranasal insulin, irinotecan hydrochloride/floxuridine, ISIS-301012, ispinesib mesylate, ixabepilone; K562/GM-CSF; Lapatinib, L-BLP-25, linezolid, liposome encapsulated paclitaxel, LY-2124275; MC-1, MC-1/lisinopril, MDX-066, melanoma vaccine, MMR-V, multivalent (ACYW) meningitis vaccine; Nilotinib, nobori, nociceptin; Oblimersen sodium, orbofiban acetate, ospemifene; Paliperidone, panitumumab, PEG-filgrastim, PEGylated interferon alfacon-1, perflubutane, pertuzumab, phenserine tartrate, phVEGF-A165, pleconaril, prasugrel, prednisolone sodium metasulfobenzoate; R-411, recombinant malaria vaccine, rhGM-CSF, roflumilast, romidepsin, ruboxistaurin mesilate hydrate; Sirolimus-eluting stent, SR-4554, St. John
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies Knowledge Area of Prous Science Integrity(R), the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, adalimumab, adefovir dipivoxil, alefacept, alemtuzumab, 3-AP, AP-12009, APC-8015, L-Arginine hydrochloride, aripiprazole, arundic acid, avasimibe; Bevacizumab, bivatuzumab, BMS-181176, BMS-184476, BMS-188797, bortezomib, bosentan, botulinum toxin type B, BQ-123, BRL-55730, bryostatin 1; CEP-1347, cetuximab, cinacalcet hydrochloride, CP-461, CpG-7909; D-003, dabuzalgron hydrochloride, darbepoetin alfa, desloratadine, desoxyepothilone B, dexmethylphenidate hydrochloride, DHA-paclitaxel, diflomotecan, DN-101, DP-b99, drotrecogin alfa (activated), duloxetine hydrochloride, duramycin; Eculizumab, Efalizumab, EKB-569, elcometrine, enfuvirtide, eplerenone, erlotinib hydrochloride, ertapenem sodium, eszopiclone, everolimus, exatecan mesilate, ezetimibe; Fenretinide, fosamprenavir calcium, frovatriptan; GD2L-KLH conjugate vaccine, gefitinib, glufosfamide, GTI-2040; Hexyl insulin M2, human insulin, hydroquinone, gamma-Hydroxybutyrate sodium; IL-4(38-37)-PE38KDEL, imatinib mesylate, indisulam, inhaled insulin, ixabepilone; KRN-5500; LY-544344; MDX-210, melatonin, mepolizumab, motexafin gadolinium; Natalizumab, NSC-330507, NSC-683864; 1-Octanol, omalizumab, ortataxel; Pagoclone, peginterferon alfa-2a, peginterferon alfa-2b, pemetrexed disodium, phenoxodiol, pimecrolimus, plevitrexed, polyphenon E, pramlintide acetate, prasterone, pregabalin, PX-12; QS-21; Ragaglitazar, ranelic acid distrontium salt, RDP-58, recombinant glucagon-like peptide-1 (7-36) amide, repinotan hydrochloride, rhEndostatin, rh-Lactoferrin, (R)-roscovitine; S-8184, semaxanib, sitafloxacin hydrate, sitaxsentan sodium, sorafenib, synthadotin
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Know- ledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: ABI-007, Ad.Egr.TNF.11D, adefovir dipivoxil, AdPEDF.11, AES-14, albumex, alefacept, alemtuzumab, aliskiren fumarate, alvimopan hydrate, aAminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anti-IL-12 MAb, aprepitant, atazanavir sulfate, atrasentan, avanafil; Banoxantrone, BG-12, bimatoprost, bortezomib, bosentan; Calcipotriol/betamethasone dipropionate, caspofungin acetate, CBT-1, ciclesonide, clofarabine, conivaptan hydrochloride, CpG-7909, C-Vax, Cypher; DA-8159, DAC:GLP-1, darbepoetin alfa, darifenacin, duloxetine hydrochloride; Eculizumab, efalizumab, efaproxiral sodium, EGF vaccine, eletriptan, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, ETC-642, etoricoxib, everolimus, exenatide; Gefitinib, IV gamma-globulin; Human insulin, gamma-hydroxybutyrate sodium; IDN-6556, iguratimod, imatinib mesylate, indiplon, ixabepilone; Laquinimod, LB-80380, lidocaine/prilocaineliraglutide, lopinavir, lopinavir/ritonavir, lucinactant; MAb-14.18, melatonin, MLN-591-DM1; NC-531, neridronic acid, nesiritide, neutrophil-inhibitory factor, niacin/lovastatin; Oblimersen sodium, olcegepant, oral Insulin, ORV-105; Palonosetron hydrochloride, PAmAb, pegaptanib sodium, peginterferon alfa-2a, pegvisomant, perifosine, pexelizumab, phenoxodiol, phenserine tartrate, pimecrolimus, pramlintide acetate, pregabalin, PRO-542, prostate cancer vaccine, PT-141; Ramelteon, rasagiline mesilate, rDNA insulin, reslizumab, rh-Lactoferrin, ribamidine hydrochloride, rosuvastatin calcium; S-8184l, SC-1, sorafenib, St. John's Wort extract, SU-11248; Taxus, telbivudine, tenofovir disoproxil fumarate, teriparatide
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort
Bayés, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Studies knowledge area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 81C6; Adefovir dipivoxil, Agalsidase alfa, AGM-1470, albumin interferon alfa, alefacept, alosetron hydrochloride, anakinra, anti-CTLA-4 Mab, aprepitant, aripiprazole, atazanavir; BAY-43-9006, BBR-3438, beta-L-Fd4C, bimatoprost, bortezomib, bosentanBR96-doxorubicin; Caspofungin acetate, ciclesonide, cilengitide, cilomilast, COL-1621, COL-3, CpG-7909, cyclosporine; DCVax-Brain, dexmethylphenidate hydrochloride, dexosome vaccine (melanoma), donepezil hydrochloride, drotrecogin alfa (activated), DTI-015, [99Tc]-DTPA-mannosyldextran, duloxetine hydrochloride; Emivirine, emtricitabine, entecavir, epothilone B, estradiol-MNP, etonogestrel/etonogestrel/ethinylestradiol, etoricoxib; Febuxostat, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GVS-111; Heparinase I, HspE7, human alpha-glucosidase, human insulin; Imatinib mesylate, INGN-241, interferon alfa B/D hybrid, interferon alfa Biphasix, ISIS-14803; Lanicemine hydrochloride, 1311-lipiodol, liposome-encapsulated mitoxantrone, lixivaptan, lumiracoxib, lupus-AHP, LY-466700; Marimastat, MEN-10755, micafungin sodium; Nitronaproxen, NSC-683864 Omalizumab, oral insulin; Palonosetron hydrochloride, peginterferon alfa-2a, pimecrolimus, pralnacasan, pramlintide acetate, pregabalin, pyrazoloacridine; R-165335, ranolazine, risperidone, RPR-109881;, RSD-1235, Satraplatin, seocalcitol, sertindole, SMART anti-interferon gamma antibody, sulfasalazine; T-138067, TAK-013, tegaserod maleate, telithromycin, tenofovir disoproxil fumarate, teriparatide, tiotropium bromide, tipifarnib, TP-38; Valdecoxib, vatalanib succinate, voriconazole; ZD-9331.
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (Z)-4-hydroxytamoxifen; Ad.muIFN-beta AD-237, adalimumab, adefovir dipivoxil, agalsidase alfa, alemtuzumab, almotriptan, ALVAC vCP1452, alvimopan hydrate, ambrisentan, anakinra, anti-IFN-gamma MAb; Bimatoprost, BMS-188797, BMS-214662, bortezomib, bosentan, bovine lactoferrin; Caffeine, canertinib dihydrochloride, canfosfamide hydrochloride, cannabidiol, caspofungin acetate, cetuximab, cH36, ChimeriVax-JE, ciclesonide, cilansetron, cinacalcet hydrochloride, clopidogrel, CpG-7909, Cypher; Daptomycin, darbepoetin alfa, darifenacin hydrobromide, decitabine, denufosol tetrasodium, Dexamet, diindolemethane, drotrecogin alfa (activated), duloxetine hydrochloride, DX-9065a; E-7010, edaravone, efalizumab, eicosapentaenoic acid/docosahexaenoic acid, elacridar, eletriptan, emtricitabine, epratuzumab, erlotinib hydrochloride, ertapenem sodium, eszopiclone, everolimus, ezetimibe; Fludarabine, fondaparinux sodium; gamma-Hydroxybutyrate sodium, gavestinel sodium, gefitinib, granisetron-Biochronomer; Human Albumin, human insulin; Imatinib mesylate, indiplon, interleukin-2 XL, isatoribine, ISS-1018, i.v. gamma-globulin, ivabradine hydrochloride, ixabepilone; Lanthanum carbonate, L-arginine hydrochloride, liposomal doxorubicin, LY-450139; Magnesium sulfate, melatonin, motexafin gadolinium, mycophenolic acid sodium salt; Natalizumab, nesiritide, niacin/lovastatin; OGX-011, olmesartan medoxomil, omalizumab, ospemifene; PACAP38, panitumumab, parathyroid hormone (human recombinant), parecoxib sodium, patupilone, pegfilgrastim, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b
The renewal of the philosophical debate in psychiatry is one exciting news of recent years. However, its use in psychopharmacology may be problematic, ranging from self-confinement into the realm of values (which leaves the evidence-based domain unchallenged) to complete rejection of scientific evidence. In this paper philosophy is conceived as a conceptual audit of clinical psychopharmacology. Its function is to criticise the epistemological and methodological problems of current neopositivist, ingenuously realist and evidence-servant psychiatry from within the scientific stance and with the aim of aiding psychopharmacologists in practicing a more self-aware, critical and possibly useful clinical practice. Three examples are discussed to suggest that psychopharmacological practice needs conceptual clarification. At the diagnostic level it is shown that the crisis of the current diagnostic system and the problem of comorbidity strongly influence psychopharmacological results, new conceptualizations more respondent to the psychopharmacological requirements being needed. Heterogeneity of research samples, lack of specificity of psychotropic drugs, difficult generalizability of results, need of a phenomenological study of drug-induced psychopathological changes are discussed herein. At the methodological level the merits and limits of evidence-based practice are considered, arguing that clinicians should know the best available evidence but that guidelines should not be constrictive (due to several methodological biases and rhetorical tricks of which the clinician should be aware, sometimes respondent to extra-scientific, economical requests). At the epistemological level it is shown that the clinical stance is shaped by implicit philosophical beliefs about the mind/body problem (reductionism, dualism, interactionism, pragmatism), and that philosophy can aid physicians to be more aware of their beliefs in order to choose the most useful view and to practice coherently
Siegel, Gerald M.; Young, Martin A.
Despite the similarity between single-subject research sessions and clinical sessions, single-subject research designs are not intrinsically more appropriate than group designs for clinical research concerning the communication disordered. (Author/CB)
... What is a clinical trial? Clinical trials are medical research studies in which people volunteer to participate. A ... or treat an eye disease or disorder. Generally, medical research begins in laboratories. After a treatment shows promise ...
Stufflebeam, Steven M
Noninvasive neuroimaging aids in surgical planning and in counseling patients about possible risks of surgery. Magnetoencephalography (MEG) performs the most common types of surgical planning that the neurosurgeon faces, including localization of epileptic discharges, determination of the hemispheric dominance of verbal processing, and the ability to locate eloquent cortex. MEG is most useful when it is combined with structural imaging, most commonly with structural magnetic resonance (MR) imaging and MR diffusion imaging. This article reviews the history of clinical MEG, introduces the basic concepts about the biophysics of MEG, and outlines the basic neurosurgical applications of MEG.
Biswas, M; Davies, J S
Hyponatraemia is defined as a serum sodium concentration below 135 mmol/l. It causes major diagnostic and management problems in practice. Hyponatraemic disorders are divided into euvolaemic, hypervolaemic and hypovolaemic. In the evaluation of the hyponatraemic patient, history taking should focus on identifying the potential cause, duration and symptomatology. Clinical examination should include assessment of volume status. Acute hyponatraemia of less than 48 h duration requires prompt correction. Treatment may involve hypertonic saline, isotonic saline and appropriate hormone replacement therapy depending on the aetiology. Chronic hyponatraemia should be treated with caution because of the risk of central pontine myelinolysis. PMID:17551067
Wells, Lloyd A
I discuss the lack of precision in the term 'clinical reasoning' and its relationship to evidence-based medicine and critical thinking. I examine critical thinking skills, their underemphasis in medical education and successful attempts to remediate them. Evidence-based medicine (and evidence-based psychiatry) offer much but are hampered by the ubiquity and flaws of meta-analysis. I explore views of evidence-based medicine among psychiatry residents, as well as capacity for critical thinking in residents before and after a course in philosophy. I discuss decision making by experienced doctors and suggest possible futures of this issue.
Sá, Pedro; Marques, Pedro; Oliveira, Carolina; Rodrigues, André Sá; Amorim, Nelson; Pinto, Rui
Gorham's disease, also known as idiopathic massive osteolysis, is a rare pathological condition characterized by vascular proliferation that results in destruction and reabsorption of the bone matrix, of unknown etiology. It was first described by Jackson in 1838, but it was Gorham and Stout, in 1955, who defined this disease as a specific entity. It has variable clinical presentation and generally has progressive behavior. Controversy continues regarding the treatment and there is no standard treatment. This pathological condition generally presents a favorable prognosis. Here, a case of Gorham's disease with involvement of the left hip is presented, in a male patient without relevant antecedents.
Dodge, H. T.; Sandler, H.
Several tables are presented giving left ventricular (LV) data for normal patients and patients with heart disease of varied etiologies, pointing out the salient features. Graphs showing LV pressure-volume relationships (compliance) are presented and discussed. The method developed by Rackley et al. (1964) for determining left ventricular mass in man is described, and limitations to the method are discussed. Some clinical methods for determining LV oxygen consumption are briefly described, and the relation of various abnormalities of ventricular performance to coronary artery disease and ischemic heart disease is characterized.
Newman, W G
Pharmacogenetics, the study of genetic variation relevant to drug metabolism, is a rapidly evolving area of medicine. This brief review will consider some of the recent advances where inherited genetic variants have been associated with either drug efficacy or toxicity. Examples of where pharmacogenetic testing has been adopted into clinical practice will be provided as well as a look at its likely development over the next decade. Finally, the large increase in genetic testing of tumour tissue samples to predict response to molecularly targeted treatments in cancer will be considered.
Aphasia is a central language impairment with word finding and comprehension deficit and paraphasias. The highlights of the essential language tests and the classification based on a scorable assessment are presented. The clinical syndromes of Broca's, global, Wernicke, conduction, anomic and transcortical aphasias are detailed with definition, localization, and prognosis. Modality specific disorders associated with aphasic syndromes are discussed. The management of the aphasic patient, consisting of informed support and coordination of available services, is often the responsibility of the family physician. ImagesFig. 1Fig. 2 PMID:21286589
Burns, Martha S
Agnosia is a neurological recognition deficit that affects a single modality. Visual agnosias include pure object agnosia, prosopagnosia, akinetopsia, and pure alexia. Auditory agnosias include pure word deafness, phonagnosia, and pure sound agnosia. New neuroimaging tools have permitted scientists to better understand the loci of lesions that cause various agnosias and from that knowledge to develop theories about the processing networks that contribute to perception and recognition in each modality. These research data, in turn, inform the rehabilitation process. By utilizing current knowledge about neuroprocessing networks, clinical professionals can differentially diagnose agnosias from aphasia and other cognitive deficits. Practical approaches to treatment of agnosia will follow once the diagnosis is established.
Mikkelsen, Carsten Sauer; Holmgren, Helene Ringe; Kjellman, Petra; Heidenheim, Michael; Kappinnen, Ari; Bjerring, Peter; Huldt-Nystrøm, Theis
Rosacea is a field within dermatology with new insight within immunological research and new treatment-algorithm. Patient education on rosacea and appropriate treatments is an important aspect in helping patients succeed with therapy. Treatment should be tailored to each individual patient, taking into account: symptoms, trigger factors, patients’ wishes, most bothersome symptoms, psychological aspect, individual needs. A combination of clinical therapies to treat different symptoms concomitantly may offer the best possible outcomes for the patient. In this review article we describe these aspects. PMID:27942368
Drane, J F
Truly professional medical ethics requires a methodology that generates both moral discernment and consistently right judgments. In this article the author briefly reviews difficulties involved in ethical decision-making, the historical development of casuistry, and four ethical methodologies employed in clinical medicine today. These latter, which are outlined and compared, are as follows: the methodology developed by David Thomasma in the 1960s and 1970s; one created by Jonsen, Siegler, and Winslade; another developed by the author; and the Bochum Protocol authored by Hans-Martin Sass et al. of the Bochum Center for Medical Ethics in the Federal Republic of Germany.
Ball, M J
This paper considers the idea of developing a clinical sociolinguistics. Various areas of the field are examined, and the importance of the 'core' area of the correlation of non-linguistic variables with linguistic variables stressed. Issues concerning language and class, region, sex, age and context of utterance are investigated, together with the implications for clinical linguistics. Finally, the difficulty of integrating such issues into clinical assessment is explored, and a tentative step forward suggested along the lines of a 'clinical sociolinguistic checklist'.
Boshuizen, Henny P. A.; Schmidt, Henk G.
A study examined the application and availability of clinical and biomedical knowledge in the clinical reasoning of physicians as well as possible mechanisms responsible for changes in the organization of clinical and biomedical knowledge in the development from novice to expert. Subjects were 28 students (10 second year, 8 fourth year, and 10…
Sakamaki, Kentaro; Yamanaka, Takeharu
Clinical trials are conducted based on the development of surgical technology and are designed to answer specific research questions. In planning clinical trials population, intervention, comparison, and outcome are important elements. Sample size calculation is also central to the design of clinical trials, especially randomized, controlled ones. This article outlines study phases, four important elements of design, and sample size calculation.
Studies have shown that clinical supervisory practices result in implementation of new skills in teachers' classroom performance. This study examines the impact of two clinical supervisory cycles on teachers' performance in classroom management. Multiple data collection tools were used to determine the impact of clinical supervisory interventions…
Gardner, Greg; Sexton, Patrick; Guyer, M. Susan; Willeford, K. Sean; Levy, Linda S.; Barnum, Mary G.; Fincher, A. Louise
Objective: To present the principles of adult learning and mentoring to help clinical instructors better educate athletic training students (ATSs) during their clinical experiences, with the end result being a better prepared, competent entry-level practitioner. Background: The principles of adult learning must be applied to ATS clinical education…
Professors and teaching staff in the field of pharmaceutical sciences should devote themselves to staying abreast of relevant education and research. Similarly those in clinical pharmacies should contribute to the advancement of pharmaceutical research and the development of next generation pharmacists and pharmaceuticals. It is thought that those who work in clinical pharmacies should improve their own skills and expertise in problem-finding and -solving, i.e., "clinical skills". They should be keen to learn new standard treatments based on the latest drug information, and should try to be in a position where collecting clinical information is readily possible. In the case of pharmacists in hospitals and pharmacies, they are able to aim at improving their clinical skills simply through performing their pharmaceutical duties. On the other hand, when a pharmaceutical educator aims to improve clinical skills at a level comparable to those of clinical pharmacists, it is necessary to devote or set aside considerable time for pharmacist duties, in addition to teaching, which may result in a shortage of time for hands-on clinical practice and/or in a decline in the quality of education and research. This could be a nightmare for teaching staff in clinical pharmacy who aim to take part in such activities. Nonetheless, I believe that teaching staff in the clinical pharmacy area could improve his/her clinical skills through actively engaging in education and research. In this review, I would like to introduce topics on such possibilities from my own experiences.
Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi
The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.
Frank, Laura L
Thiamin is a water-soluble vitamin also known as vitamin B1. Its biologically active form, thiamin pyrophosphate (TPP), is a cofactor in macronutrient metabolism. In addition to its coenzyme roles, TPP plays a role in nerve structure and function as well as brain metabolism. Signs and symptoms of thiamin deficiency (TD) include lactic acidosis, peripheral neuropathy, ataxia, and ocular changes (eg, nystagmus). More advanced symptoms include confabulation and memory loss and/or psychosis, resulting in Wernicke's encephalopathy and/or Wernicke's Korsakoff syndrome, respectively. The nutrition support clinician should be aware of patients who may be at risk for TD. Risk factors include those patients with malnutrition due to 1 or more nutrition-related etiologies: decreased nutrient intake, increased nutrient losses, or impaired nutrient absorption. Clinical scenarios such as unexplained heart failure or lactic acidosis, renal failure with dialysis, alcoholism, starvation, hyperemesis gravidarum, or bariatric surgery may increase the risk for TD. Patients who are critically ill and require nutrition support may also be at risk for TD, especially those who are given intravenous dextrose void of thiamin repletion. Furthermore, understanding thiamin's role as a potential therapeutic agent for diabetes, some inborn errors of metabolism, and neurodegenerative diseases warrants further research. This tutorial describes the absorption, digestion, and metabolism of thiamin. Issues pertaining to thiamin in clinical practice will be described, and evidence-based practice suggestions for the prevention and treatment of TD will be discussed.
Gohil, Ishan; Vilensky, Joel A; Weber, Edward C
Vacuum phenomenon (VP) is an anatomical entity of potential confusion in the diagnosis and evaluation of joint pathology. Observation of this phenomenon has been demonstrated on basic radiographs, computed tomography, and magnetic resonance imaging. Although VP is most often associated with degenerative joint disease, it is observed with other pathologies. Two problematic scenarios can occur: a false-positive diagnosis of serious pathology instead of benign VP and a false-negative diagnosis of benign VP with a more serious underlying process Despite this potential for confusion, criteria for distinguishing VP from other causes of joint pain and for evaluating a suspected case of VP have not been fully established. We reviewed the literature to determine underlying mechanism, symptomology, associated pathologies, and clinical importance of VP. The formation of VP can be explained by gas solubility, pressure-volume relationships, and human physiology. CT, GRE-MRI, and multipositional views are the best imaging studies to view VP. Although most cases of VP are benign, it can be associated with clinical signs and symptoms. VP outside the spine is an underreported finding on imaging studies. VP should be on the differential diagnosis for joint pain, especially in the elderly. We have proposed criteria for diagnosing VP and generated a basic algorithm for its workup. Underreporting of this phenomenon shows a lack of awareness of VP on the part of physicians. By identifying true anatomic VP, we can prevent harm from suboptimal treatment of patients.
Gaspare de Santo, Natale; Bisaccia, Carmela; Cirillo, Massimo; Salvatore de Santo, Luca; Richet, Gabriel
Clinical practice became clinical science in the years 1720-1820. There were many reasons for this transformation. The discoveries by Santorio Santorio, William Harvey, Marcello Malpighi, Giovanni Alfonso Borelli, Lorenzo Bellini, Thomas Sydenham, Giovanni Maria Lancisi, were perceived by students who asked for changes in the medical curriculum. In 1761 Morgagni centered the study of diseases on morbid anatomy, a way to control at autopsy the validity of diagnosis. J.P. Frank who worked on public health and John Locke who supported a method of scientific reasoning based on asking questions were also instrumental for changes. Hospitals, formerly hospices for the poor, became places for curing and healing. Military hospitals represented models to be followed. In Vienna Marie Therese inaugurated the Allegemein Krankenhaus in 1785. In revolutionary France Fourcroy with the law Frimaire An III, 1794 gave a new rationale. Medicine and surgery were unified in the curriculum. Basic sciences were introduced. Dissection became compulsory, practical teaching became the rule. But it was with John Hunter, Domenico Cotugno and P. Joseph Desault that the great advancement was achieved. They were anatomists and therefore they made the knowledge of human body the core of medical curriculum. However experimentation on animals, as well as practical bedside teaching at the hospital also became important. Through their work hospitals and universities were associated in a common goal.
Satya Krishna, Surabhi Venkata; Kota, Sunil K.; Modi, Kirtikumar D.
Glycemic control and its benefits in preventing microvascular diabetic complications are convincingly proved by various prospective trials. Diabetes control and complications trial (DCCT) had reported variable glycated hemoglobin (HbA1C) as a cause of increased microvascular complications in conventional glycemic control group versus intensive one. However, in spite of several indirect evidences, its link with cardiovascular events or macrovascular complications is still not proved. Glycemic variability (GV) is one more tool to explain relation between hyperglycemia and increased cardiovascular risk in diabetic patients. In fact GV along with fasting blood sugar, postprandial blood sugar, HbA1C, and quality of life has been proposed to form glycemic pentad, which needs to be considered in diabetes management. Postprandial spikes in blood glucose as well as hypoglycemic events, both are blamed for increased cardiovascular events in Type 2 diabetics. GV includes both these events and hence minimizing GV can prevent future cardiovascular events. Modern diabetes management modalities including improved sulfonylureas, glucagon like peptide-1 (GLP-1)-based therapy, newer basal insulins, and modern insulin pumps address the issue of GV effectively. This article highlights mechanism, clinical implications, and measures to control GV in clinical practice. PMID:23961476
Chassany, O; Duracinský, M
The current reference guideline about ethics in clinical trials is the Declaration of Helsinki of human rights in medical research. Three major principles are emphasised: respect of the patient to accept or not to participate in a trial, the constraints and the presumed risks must be acceptable for patients included in a study, and vulnerable subjects should not participate in studies. The investigator is responsible for obtaining a free and well-informed consent from patients before their inclusion in a study. Where possible, a new drug should always first be compared to placebo in order to prove its superiority. Else, a small-sized trial comparing a new drug versus a reference treatment can lead to an erroneous conclusion of absence of difference. Moreover, good results or improvement are obtained in at least 30% of cases with placebo, whatever the disease. The use of placebo is unethical in life-threatening diseases and when an effective proved drug exists. The use of placebo is ethical in severe diseases with no efficient drug, in some severe diseases even when an active reference treatment is available, and in all moderate and functional diseases. In order to detect flawed studies, most journals now ask for any manuscript submitted and reporting results of a randomised clinical trial to join a checklist in order to verify the quality of the trial. Finally, it remains the responsibility of the doctor to decide whether or not a protocol is ethical, to participate or not and to include patients or not.
Mathisen, G E; Meyer, R D; Thompson, J M; Finegold, S M
Moxalactam was administered intravenously or intramuscularly or both in doses of 1 to 12 g/day to 45 patients with clinically significant infections (17 soft tissue or bone, 9 pleuropulmonary, 9 septicemic, 6 urinary tract, and 4 intraabdominal infections). Mean 0.5-h postinfusion levels were 105 micrograms/ml for a 4.0-g dose, 44.7 micrograms/ml for a 2.0-g dose, and 18 micrograms/ml for a 1.0-g dose. We identified 28 isolates of Enterobacteriaceae, 10 Pseudomonas aeruginosa isolates, 9 Staphylococcus aureus isolates, and 15 anaerobic bacterial isolates. A total of 15 patients were clinically cured, 8 patients improved, 13 patients improved initially but suffered subsequent relapses or superinfections, and 10 patients failed therapy. Toxicity was generally minimal (reversible eosinophilia, and mild liver function abnormalities, and elevated prothrombin time). The selection or emergence of resistant organisms in 17 patients during treatment (particularly Pseudomonas, enterococci, and Candida) was a disturbing feature of therapy. Our results were generally favorable, considering the complicated underlying medical problems of this group of patients. PMID:6213198
Guarnero, A.; Marzuoli, M.; Molino, G.; Terenziani, P.; Torchio, M.; Vanni, K.
In this paper, we propose an approach for managing clinical guidelines. We sketch a modular architecture, allowing us to separate conceptually distinct aspects in the management and use of clinical guidelines. In particular, we describe the clinical guidelines knowledge representation module and we sketch the acquisition module. The main focus of the paper is the definition of an expressive formalism for representing clinical guidelines, which allows one to deal with the context dependent character of clinical guidelines and takes into account different temporal aspects. PMID:9929306
Tomillero, A; Moral, M A
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com.This issue focuses on the following selection of drugs: ABT-263, AC-2307, Aclidinium bromide, Adefovir dipivoxil, ADH-1, Agatolimod sodium, Alefacept, Aliskiren fumarate, Aminolevulinic acid methyl ester, Anakinra, Apaziquone, Aprepitant, Aripiprazole, ASM-8, Atiprimod hydrochloride, AVE-0277, AVE-1642, AVE-8062, Axitinib, Azacitidine, AZD-0530; Bazedoxifene acetate, Bevacizumab, Bexarotene, BI-2536, Biphasic insulin aspart, BMS-387032, BMS-663513, Bortezomib, BQ-123, Brivanib alaninate, BSI-201; Caspofungin acetate, CDX-110, Cetuximab, Ciclesonide, CR-011, Cypher; Daptomycin, Darbepoetin alfa, Dasatinib, Decitabine, Deferasirox, Denosumab, Dexlansoprazole, Dexmethylphenidate hydrochloride, DNA-Hsp65 vaccine, Dovitinib, Drotrecogin alfa (activated), DTaP-HBV-IPV/Hibvaccine, DTaP-IPV-HB-PRP-T, Duloxetine hydrochloride, Dutasteride; Ecogramostim, Elacytarabine, Emtricitabine, Endothelin, Entecavir, Eplivanserin fumarate, Escitalopram oxalate, Everolimus, Ezetimibe, Ezetimibe/simvastatin; Farletuzumab, Fesoterodine fumarate, Fibrin sealant (human), Fulvestrant; Gefitinib, Gemtuzumab ozogamicin, Glufosfamide, GSK-1562902A; Hib-TT; Imatinib mesylate, IMC-11F8, Imidazoacridinone, IMP-321, INCB-18424, Indiplon, Indisulam, INNO-406, Irinotecan hydrochloride/Floxuridine, ITF-2357, Ixabepilone; KRN-951; Lasofoxifene tartrate; Lenalidomide, LGD-4665, Lonafarnib, Lubiprostone, Lumiliximab; MDX-1100, Melan-A/MART-1/gp100/IFN-alfa, Methyl-CDDO, Metreleptin, MLN-2704, Mycophenolic acid sodium salt; Na-ASP-2, Naproxcinod, Nilotinib hydrochloride monohydrate, NPI-2358; Oblimersen sodium, Odanacatib; Paclitaxel nanoparticles, PAN-811, Panobinostat, PBI-1402, PC-515, Peginterferon alfa
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 131I-labetuzumab; Abacavir sulfate, abatacept, adalimumab, ademetionine, adjuvanted influenza vaccine, alefacept, alemtuzumab, amlodipine, amphotericin B, anakinra, aripiprazole, aspirin, axitinib; Betamethasone dipropionate, bevacizumab, biphasic insulin aspart, bortezomib, bosentan, botulinum toxin type B, BQ-123; Calcium folinate, canertinib dihydrochloride, carboplatin, carmustine, cetirizine hydrochloride, cetuximab, cholecalciferol, ciclesonide, ciclosporin, cinacalcet hydrochloride, cisplatin, clarithromycin, clofazimine, cold-adapted influenza vaccine trivalent, CpG-7909; Darbepoetin alfa, darifenacin hydrobromide, DB-289, desloratadine, Dexamet, dicycloverine hydrochloride, dimethyl fumarate, docetaxel, dolastatin 10, drospirenone, drospirenone/estradiol, duloxetine hydrochloride; Ecogramostim, edotecarin, efaproxiral sodium, enalapril maleate, epoetin beta, epoprostenol sodium, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, estradiol, etanercept; Fluconazole, fludarabine phosphate, fluorouracil; Gefitinib, gemcitabine, Ghrelin (human), glibenclamide, glimepiride, GTI-2040; Haloperidol, human insulin, hydrocortisone probutate; Imatinib mesylate, indisulam, influenza vaccine, inhaled insulin, insulin aspart, insulin glulisine, insulin lispro, irinotecan, ispronicline; Lamivudine, lamivudine/zidovudine/abacavir sulfate, lapatinib, letrozole, levocetirizine, lomustine, lonafarnib, lumiracoxib;Magnesium sulfate, MD-1100, melphalan, metformin hydrochloride, methotrexate, metoclopramide hydrochloride, mitiglinide calcium hydrate, monophosphoryl lipid A, montelukast sodium, motexafin gadolinium
Bayes, M; Rabasseda, X; Prous, J R
Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: (-)-Epigallocatechin gallate; ACP-103, Ad.Egr.TNF.11 D, adalimumab, AF-IL 12, AIDSVAX gp120 B/B, alefacept, alemtuzumab, a-Galactosylceramide, ALVAC vCP 1452, alvimopan hydrate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, anakinra, anidulafungin, antarelix, aprepitant, aripiprazole, arsenic sulfide, asoprisnil, atazanavir sulfate, atomoxetine hydrochloride; Bevacizumab, bimatoprost, BMS-184476, bortezomib, bosentan, botulinum toxin type B, BrachySil, brivudine; Caffeine, calcipotriol/betamethasone dipropionate, cannabidiol, capsaicin for injection, caspofungin acetate, CC-4047, cetuximab, CGP-36742, clofazimine, CpG-7909, Cypher; Darbepoetin alfa, dextromethorphan/quinidine sulfate, dimethylfumarate, dronabinol/cannabidiol, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Ecogramostim, efalizumab, eletriptan, emtricitabine, enfuvirtide, eplerenone, esomeprazole magnesium, estradiol acetate, eszopiclone, etoricoxib, exenatide, ezetimibe, ezetimibe/simvastatin; Fampridine, fondaparinux sodium, fosamprenavir calcium; Gefitinib, GPI-0100; hA 20, HTU-PA, human insulin, HuOKT 3 gamma 1(Ala 234-Ala 235), hyaluronic acid; Icatibant, imatinib mesylate, Indiplon, INKP-100, INKP-102, iodine (I131) tositumomab, istradefylline, IV gamma-globulin, ivabradine hydrochloride, ixabepilone; Lacosamide, landiolol, lanthanum carbonate, lasofoxifene tartrate, LB-80380, lenalidomide, lidocaine/tetracaine, linezolid, liposomal doxorubicin, liposomal vincristine sulfate, lopinavir, lopinavir/ritonavir, lumiracoxib, lurtotecan; Maribavir, morphine glucuronide, MVA-5 T
Musgrove, John L; Morris, Jason; Estrada, Carlos A; Kraemer, Ryan R
Background Published clinical problem solving exercises have emerged as a common tool to illustrate aspects of the clinical reasoning process. The specific clinical reasoning terms mentioned in such exercises is unknown. Objective We identified which clinical reasoning terms are mentioned in published clinical problem solving exercises and compared them to clinical reasoning terms given high priority by clinician educators. Methods A convenience sample of clinician educators prioritized a list of clinical reasoning terms (whether to include, weight percentage of top 20 terms). The authors then electronically searched the terms in the text of published reports of 4 internal medicine journals between January 2010 and May 2013. Results The top 5 clinical reasoning terms ranked by educators were dual-process thinking (weight percentage = 24%), problem representation (12%), illness scripts (9%), hypothesis generation (7%), and problem categorization (7%). The top clinical reasoning terms mentioned in the text of 79 published reports were context specificity (n = 20, 25%), bias (n = 13, 17%), dual-process thinking (n = 11, 14%), illness scripts (n = 11, 14%), and problem representation (n = 10, 13%). Context specificity and bias were not ranked highly by educators. Conclusions Some core concepts of modern clinical reasoning theory ranked highly by educators are mentioned explicitly in published clinical problem solving exercises. However, some highly ranked terms were not used, and some terms used were not ranked by the clinician educators. Effort to teach clinical reasoning to trainees may benefit from a common nomenclature of clinical reasoning terms.
Comfrey has a centuries-old tradition as a medicinal plant. Today, multiple randomized controlled trials have demonstrated the efficacy and safety of comfrey preparations for the topical treatment of pain, inflammation and swelling of muscles and joints in degenerative arthritis, acute myalgia in the back, sprains, contusions and strains after sports injuries and accidents, also in children aged 3 or 4 and over. This paper provides information on clinical trials and non-interventional studies published on comfrey to date and further literature, substantiating the fact that topical comfrey preparations are a valuable therapy option for the treatment of painful muscle and joint complaints. Copyright © 2012 John Wiley & Sons, Ltd. PMID:22359388
Ghooi, Ravindra B.; Divekar, Deepa
Aims and Objectives: Sponsors need to pay for management of all serious adverse events suffered by subjects in a clinical trial and to compensate for injuries or deaths related to the trial. This study examines if insurance policies of trials, cover all contingencies that require reimbursement or compensation. Materials and Methods: Insurance policies of trials submitted to Sahyadri Hospitals between January 2013 and December 2013 were studied, with respect to the policy period, the limit of liability, deductibles, and preconditions if any. Results: All the policies studied had some deficiencies, in one respect or the other and none had a provision to pay full compensation if required. Some insurers have put in preconditions that could jeopardize the payment of compensation to subjects. Conclusions: Insurances are complicated documents, and need to be critically examined by the ethics committee before approval of the study documents. PMID:25276622
The meaning of the term "logagogy" is elucidated, and logagogic practices are outlined in the history of medicine. It is shown how the traditional medicine of India, Ayurveda, shows signs of logagogic practices (sattvavajaya), and that not only Ayurveda but also the famous Greek physician Galenus emphasize a philosophical approach to medicine. As Galenus's logagogic practices have their roots in the tradition of practical philosophy in Greek antiquity, the most important Greek schools of thought that are relevant to logagogic approaches are sketched. It is shown that the Stoics created a rationalistic system emphasizing the importance of the logos for human beings, and that Epicurus made advances in psychoeducation and cognitive reframing that are important for logagogic practices. These logagogic approaches of antiquity have been taken up by modern counseling in philosophical practices. The article closes with an outline of a clinical logagogy.
Phan, Xiem; Ling, Paul H
Adult patients seeking orthodontic treatment are increasingly motivated by esthetic considerations. The majority of these patients reject wearing labial fixed appliances and are looking instead to more esthetic treatment options, including lingual orthodontics and Invisalign appliances. Since Align Technology introduced the Invisalign appliance in 1999 in an extensive public campaign, the appliance has gained tremendous attention from adult patients and dental professionals. The transparency of the Invisalign appliance enhances its esthetic appeal for those adult patients who are averse to wearing conventional labial fixed orthodontic appliances. Although guidelines about the types of malocclusions that this technique can treat exist, few clinical studies have assessed the effectiveness of the appliance. A few recent studies have outlined some of the limitations associated with this technique that clinicians should recognize early before choosing treatment options.
An analysis of the normal tissue effects of irradiation of the kidney is presented. Various clinical syndromes resulting from treatment are described as well as the potential cellular basis for these findings. Effects of concurrent and/or sequential treatment with irradiation and various chemotherapeutic agents are discussed and the impact of these agents on toxicity presented. Adverse consequences of renal treatment in the child is described and possible radiation effects on so-called compensatory hypertrophy following nephrectomy presented. Renal consequences described to date of bone marrow transplantation programs utilizing irradiation are also presented. The necessity of a dose-volume histogram analysis approach to analyzing renal toxic effects in patients followed for long (>10 year) periods is essential in developing accurate guidelines of renal tolerance. 53 refs., 6 figs., 5 tabs.
Osteoporosis is defined by decreased bone density and microarchitectural deterioration that predispose to fragility fractures. The WHO diagnostic criteria of osteoporosis require bone densitometry but treatment is possible on the basis of high clinical fracture risk and can be assessed by the FRAX risk algorithm. All those subject to fracture risk should be advised about proper basic treatment of osteoporosis, including exercise, prevention of falls, smoking cessation, avoidance of alcohol intake, and dietary or supplemental abundance of calcium and vitamin D. Underlying diseases must be studied after diagnosis of osteoporosis even if treatment is initiated without densitometry. When indicated, specific osteoporosis therapy includes bisphosphonates, denosumab, teriparatide, strontium ranelate or SERMs. In hypogonadism, gonadal steroids may be indicated alone or in addition to a specific treatment. Treatment effect and continuation are assessed after 2 to 5 years.
Biosensors are analytical devices composed of a recognition element of biological origin and a physico-chemical transducer. The biological element is capable of sensing the presence, activity or concentration of a chemical analyte in solution. The sensing takes place either as a binding event or a biocatalytical event. These interactions produce a measurable change in a solution property, which the transducer converts into a quantifiable electrical signal. Present-day applications of biosensors to clinical chemistry are reviewed, including basic and applied research, commercial applications and fabrication techniques. Recognition elements include enzymes as biocatalytic recognition elements and immunoagents and DNA segments as affinity ligand recognition elements, coupled to electrochemical and optical modes of transduction. The future will include biosensors based on synthetic recognition elements to allow broad applicability to different classes of analytes and modes of transduction extending lower limits of sensitivity. Microfabrication will permit biosensors to be constructed as arrays and incorporated into lab-on-a-chip devices.
This is a case of a 21-year-old lady who presented with history of episodes where she would display extraordinary strength while becoming aggressive towards her family members, speak in foreign language and display bizarre behaviour. The episode would last for 15–20 min and would resolve spontaneously. She would always claim amnesia for the event. This would remain irritable in the intervening period. The frequency of such episodes is at least three times a week. The family members took her to several faith healers with no improvement in her condition. On the suggestion of a family friend, the patient was brought in for consultation in the psychiatric clinic. The patient remained a diagnostic dilemma though there has been some reduction in intensity of such episodes on psychotropic medication. Unfortunately, there is no remission in episodes. PMID:22701065
Claims for compensation in cases of clinical negligence have risen dramatically in recent years. The implementation of the NHS reforms, with greater clarity of roles and responsibilities and the emphasis on devolving decision-making as close to the patient as possible, is meant to affect the entire performance of healthcare delivery. For most senior managers and clinicians, the environment in which they operate has grown increasingly turbulent and complex. Both purchasers and providers of health care want the best and most effective and efficient care. The cost and quality of care are components in determining the value of health care delivered, and both are elements of healthcare risk. To begin to manage these elements of risk, the process of healthcare risk modification can be applied. Healthcare risk modification provides the best service for patients through obtaining a synergy between risk management, quality and the law.
Reiter, Russel J; Korkmaz, Ahmet
Melatonin is produced in the human pineal gland, particularly at night, with the circadian rhythm of blood melatonin levels closely paralleling its production within the pineal gland. Light exposure at night, or rapid transmeridian travel severely compromises the circadian production of melatonin. The disturbed melatonin rhythm contributes to jet lag and sleep inefficiency, both of which are improved by melatonin administration. Melatonin is also a highly effective direct free radical scavenger and antioxidant. In this capacity, melatonin reduces experimental cataractogenesis, traumatic injury to the spinal cord and brain, and protects against oxidative damage to neurons and glia in models of stroke, Parkinsonism, and Alzheimer's disease. Additionally, melatonin and its metabolites are highly effective in protecting against ionizing radiation. Finally, melatonin may be a treatment for hypertension. Melatonin's high efficacy, its high safety profile, and its virtual lack of toxicity make it of interest in clinical medicine.
Goodman, Steven N.
This dissertation explores the use of a mathematical measure of statistical evidence, the log likelihood ratio, in clinical trials. The methods and thinking behind the use of an evidential measure are contrasted with traditional methods of analyzing data, which depend primarily on a p-value as an estimate of the statistical strength of an observed data pattern. It is contended that neither the behavioral dictates of Neyman-Pearson hypothesis testing methods, nor the coherency dictates of Bayesian methods are realistic models on which to base inference. The use of the likelihood alone is applied to four aspects of trial design or conduct: the calculation of sample size, the monitoring of data, testing for the equivalence of two treatments, and meta-analysis--the combining of results from different trials. Finally, a more general model of statistical inference, using belief functions, is used to see if it is possible to separate the assessment of evidence from our background knowledge. It is shown that traditional and Bayesian methods can be modeled as two ends of a continuum of structured background knowledge, methods which summarize evidence at the point of maximum likelihood assuming no structure, and Bayesian methods assuming complete knowledge. Both schools are seen to be missing a concept of ignorance- -uncommitted belief. This concept provides the key to understanding the problem of sampling to a foregone conclusion and the role of frequency properties in statistical inference. The conclusion is that statistical evidence cannot be defined independently of background knowledge, and that frequency properties of an estimator are an indirect measure of uncommitted belief. Several likelihood summaries need to be used in clinical trials, with the quantitative disparity between summaries being an indirect measure of our ignorance. This conclusion is linked with parallel ideas in the philosophy of science and cognitive psychology.
Jordan, Holly L; Register, Thomas C; Tripathi, Niraj K; Bolliger, Anne Provencher; Everds, Nancy; Zelmanovic, David; Poitout, Florence; Bounous, Denise I; Wescott, Debra; Ramaiah, Shashi K
Most published reviews of preclinical toxicological clinical pathology focus on the fundamental aspects of hematology, clinical chemistry, coagulation, and urinalysis in routine toxicology animal species, for example, rats, mice, dogs, and nonhuman primates. The objective of this continuing education course was to present and discuss contemporary examples of nonroutine applications of clinical pathology endpoints used in the drug development setting. Area experts discussed bone turnover markers of laboratory animal species, clinical pathology of pregnant and growing laboratory animals, clinical pathology of nonroutine laboratory animal species, and unique applications of the Siemens Advia(®) hematology analyzer. This article is a summary based on a presentation given at the 31st Annual Symposium of the Society of Toxicologic Pathology, during the Continuing Education Course titled "Nontraditional Applications of Clinical Pathology in Drug Discovery and Preclinical Toxicology."
Queraltó, J M
Clinical biochemistry in Spain was first established in 1978 as an independent specialty. It is one of several clinical laboratory sciences specialties, together with haematology, microbiology, immunology and general laboratory (Clinical analysis, análisis clinicos). Graduates in Medicine, Pharmacy, Chemistry and Biological Sciences can enter post-graduate training in Clinical Chemistry after a nation-wide examination. Training in an accredited Clinical Chemistry department is 4 years. A national committee for medical and pharmacist specialties advises the government on the number of trainees, program and educational units accreditation criteria. Technical staff includes nurses and specifically trained technologists. Accreditation of laboratories is developed at different regional levels. The Spanish Society for Clinical Biochemistry and Molecular Pathology (SECQ), the national representative in the IFCC, has 1600 members, currently publishes a scientific journal (Química Clinica) and a newsletter. It organizes a continuous education program, a quality control program and an annual Congress.
King, S.W.; Savory, J.; Wills, M.R.
Aluminum toxicity has been implicated in the pathogenesis of a number of clinical disorders in patients with chronic renal failure on long-term intermittent hemodialysis treatment. The predominant disorders have been those involving either bone (osteomalacic dialysis osteodystrophy) or brain (dialysis encephalopathy). In nonuremic patients, an increased brain aluminum concentration has been implicated as a neurotoxic agent in the pathogenesis of Alzheimer's disease and was associated with experimental neurofibrillary degeneration in animals. The brain aluminum concentrations of patients dying with the syndrome of dialysis encephalopathy (dialysis dementia) are significantly higher than in dialyzed patients without the syndrome and in nondialyzed patients. Two potential sources for the increased tissue content of aluminum in patients on hemodialysis have been proposed: (1) intestinal absorption from aluminum containing phosphate-binding gels, and (2) transfer across the dialysis membrane from aluminum in the water used to prepare the dialysate. These findings, coupled with our everyday exposure to the ubiquitous occurrence of aluminum in nature, have created concerns over the potential toxicity of this metal.
The patient-physician encounter is the pivotal starting point of any healthcare delivery, but it is subject to multiple process breakdowns and prevalent suboptimal performance. An overview of the techniques and components of a successful encounter valid for every setting and readily applicable is presented, stressing 7 rules: (1) ensuring optimal environment, tools, and teamwork; (2) viewing each encounter not only as a cognitive/biomedical challenge, but also as a personal one, and a learning opportunity; (3) adopting an attitude of curiosity, concentration, compassion, and commitment, and maintaining a systematic, orderly approach; (4) "simple is beautiful"-making the most of the basic clinical data and their many unique advantages; (5) minding "the silent dimension"-being attentive to the patient's identity and emotions; (6) following the "Holy Trinity" of gathering all information, consulting databases/colleagues, and tailoring gained knowledge to the individual patient; and (7) using the encounter as a "window of opportunity" to further the patient's health-not just the major problem, by addressing screening and prevention; promoting health literacy and shared decision-making; and establishing proper follow-up. Barriers to implementation identified can be overcome by continuous educational interventions. A high-quality encounter sets a virtuous cycle of patient-provider interaction and results in increasing satisfaction, adherence, and improved health outcomes.
Gonzales, Patrick R; Carroll, Andrew J; Korf, Bruce R
Chromosome analysis is one of the first approaches to genetic testing and remains a key component of genetic analysis of constitutional and somatic genetic disorders. Numerical or unbalanced structural chromosome abnormalities usually lead to multiple congenital anomalies. Sometimes these are compatible with live birth, usually resulting in severe cognitive and physical handicaps; other times they result in miscarriage or stillbirth. Chromosome rearrangements also occur as somatic changes in malignancies. Identification of constitutional chromosomal anomalies (anomalies present in most or all cells of the body and/or the germline) can provide important information for genetic counseling. In this unit, we introduce chromosomal microarray analysis (CMA), which is a relatively recent addition to cytogenetic technologies, and has become the recommended first-tier testing method for patients with developmental delay, intellectual disability, autism, and/or multiple congenital anomalies. We also discuss non-invasive prenatal testing/screening (NIPTS), which uses circulating cell-free fetal DNA (cfDNA) from maternal plasma to rapidly screen for autosomal and sex-chromosome aneuploidies. Cytogenetic analysis of tumors is helpful in diagnosis and in monitoring the effects of treatment. The protocols in this chapter cover the clinical study of chromosomes in nonmalignant tissues.
Maristany, Cleofé Pérez-Portabella; Segurola Gurruchaga, Hegoi
Water is an essential foundation for life, having both a regulatory and structural function. The former results from active and passive participation in all metabolic reactions, and its role in conserving and maintaining body temperature. Structurally speaking it is the major contributer to tissue mass, accounting for 60% of the basis of blood plasma, intracellular and intersticial fluid. Water is also part of the primary structures of life such as genetic material or proteins. Therefore, it is necessary that the nurse makes an early assessment of patients water needs to detect if there are signs of electrolyte imbalance. Dehydration can be a very serious problem, especially in children and the elderly. Dehydrations treatment with oral rehydration solution decreases the risk of developing hydration disorders, but even so, it is recommended to follow preventive measures to reduce the incidence and severity of dehydration. The key to having a proper hydration is prevention. Artificial nutrition encompasses the need for precise calculation of water needs in enteral nutrition as parenteral, so the nurse should be part of this process and use the tools for calculating the patient's requirements. All this helps to ensure an optimal nutritional status in patients at risk. Ethical dilemmas are becoming increasingly common in clinical practice. On the subject of artificial nutrition and hydration, there isn't yet any unanimous agreement regarding hydration as a basic care. It is necessary to take decisions in consensus with the health team, always thinking of the best interests of the patient.
Black, Dennis M; Rosen, Clifford J
Key Clinical Points Postmenopausal Osteoporosis Fractures and osteoporosis are common, particularly among older women, and hip fractures can be devastating. Treatment is generally recommended in postmenopausal women who have a bone mineral density T score of -2.5 or less, a history of spine or hip fracture, or a Fracture Risk Assessment Tool (FRAX) score indicating increased fracture risk. Bisphosphonates (generic) and denosumab reduce the risk of hip, nonvertebral, and vertebral fractures; bisphosphonates are commonly used as first-line treatment in women who do not have contraindications. Teriparatide reduces the risk of nonvertebral and vertebral fractures. Osteonecrosis of the jaw and atypical femur fractures have been reported with treatment but are rare. The benefit-to-risk ratio for osteoporosis treatment is strongly positive for most women with osteoporosis. Because benefits are retained after discontinuation of alendronate or zoledronic acid, drug holidays after 5 years of alendronate therapy or 3 years of zoledronic acid therapy may be considered for patients at lower risk for fracture.
Ayres, Thomas R.
The Dynamo Clinical Trial evaluates long-term stellar magnetic health through periodic X-ray examinations (by the Chandra Observatory). So far, there are only three subjects enrolled in the DTC: Alpha Centauri A (a solar-like G dwarf), Alpha Cen B (an early K dwarf, more active than the Sun), and Alpha Canis Majoris A (Procyon, a mid-F subgiant similar in activity to the Sun). Of these, Procyon is a new candidate, so it is too early to judge how it will fare. Of the other two, Alpha Cen B has responded well, with a steady magnetic heartbeat of about 8 years duration. The sickest of the bunch, Alpha Cen A, was in magnetic cardiac arrest during 2005-2010, but has begun responding to treatment in recent years, and seems to be successfully cycling again, perhaps achieving a new peak of magnetic health in the 2016 time frame. If this is the case, it has been 20 years since A's last healthful peak, significantly longer than the middle-aged Sun's 11-year magnetic heartbeat, but perhaps in line with Alpha Cen A's more senescent state (in terms of "relative evolutionary age," apparently an important driver of activity). (By the way, don't miss the exciting movie of the Alpha Cen stars' 20-year X-ray dance.)
Platt, Philip S.
One million, two hundred and fifty thousand individuals were treated in one hundred and twenty-two clinics in New York City in 1913 for venereal disease, yet in most of these clinics one could not determine the results of such treatment. Mr. Platt in this paper criticizes the filing systems in general use in these clinics and suggests a remedy in the form of a cross indexing by diseases. PMID:18009536
Glazebrook, S G; Buchanan, J G
This paper describes a model of clinical governance that was developed at South Auckland Health during the period 1995 to 2000. Clinical quality and safety are core objectives. A multidisciplinary Clinical Board is responsible for the development and publicising of sound clinical policies together with monitoring the effects of their implementation on quality and safety. The Clinical Board has several committees, including an organization-wide Continuous Quality Improvement Committee to enhance the explicit nature of the quality system in terms of structure, staff awareness and involvement, and to develop the internal audit system. The second stream stems from the Chief Medical Officer and clinical directors in a clinical management sense. The Audit Committee of the Board of Directors covers both clinical and financial audit. The reporting lines back to that committee are described and the role of the external auditor of clinical standards is explained. The aim has been to create a supportive culture where quality initiatives and innovation can flourish, and where the emphasis is not on censure but improvement.
Chen, Yalan; Lin, Yuxin; Yuan, Xuye; Shen, Bairong
In order to achieve more accurate disease prevention, diagnosis, and treatment, clinical and genetic data need extensive and systematically associated study. As one way to achieve precision medicine, a laboratory information management system (LIMS) can effectively associate clinical data in a macrocosmic aspect and genomic data in a microcosmic aspect. This chapter summarizes the application of the LIMS in a clinical data management and implementation mode. It also discusses the principles of a LIMS in clinical data management, as well as the opportunities and challenges in the context of medical informatics.
Dadge, Jean; Casey, Dawn
Students who entered training as of September 2007 are required to have a 'sign-off mentor' in their final clinical placement to register with the Nursing and Midwifery Council. The sign-off mentor status is mandatory for confirming that, on completion of the final clinical placement, the student has met all the requirements of the pre-registration clinical assessment criteria and can register as a qualified nurse. This article describes the role of the clinical teacher in preparing and supporting mentors in one area of Wales.
Terenziani, P.; Mastromonaco, F.; Molino, G.; Torchio, M.
In our previous work, we proposed a domain-independent language to describe clinical guidelines and a graphical tool to acquire them. In this paper, we describe an approach to execute clinical guidelines. We propose a flexible execution engine that can be used in clinical decision support applications, and also for medical education, or for integrating guidelines into the clinical workflow. We also focus our attention on temporal issues in the execution of guidelines, including the treatment of composite, concurrent and/or cyclic actions. PMID:11080004
Phillips, Daniel E.
This article describes an experiential learning activity designed to integrate classroom knowledge and a clinical swallowing assessment. Twenty master's-level graduate students in a dysphagia course conducted a clinical swallowing assessment with a resident of an independent retirement community. The exercise was designed to allow students an…
The establishment of the modern discipline of clinical chemistry was concurrent with the foundation of the journal Clinical Chemistry and that of the American Association for Clinical Chemistry in the late 1940s and early 1950s. To mark the 50th volume of this Journal, I chronicle and highlight scientific milestones, and those within the discipline, as documented in the pages of Clinical Chemistry. Amazing progress has been made in the field of laboratory diagnostics over these five decades, in many cases paralleling-as well as being bolstered by-the rapid pace in the development of computer technologies. Specific areas of laboratory medicine particularly well represented in Clinical Chemistry include lipids, endocrinology, protein markers, quality of laboratory measurements, molecular diagnostics, and general advances in methodology and instrumentation.
Merrell, Ronald C.
Communication among physicians is an essential in order to combine our experiences for the elucidation and application of new knowledge and for the accurate and uniform application of established medical practice. This communication requires an adequate understanding of the culture of the patient and the social context of disease and indeed the culture of the physician. Malnutrition in Bangladesh means caloric insufficiency, and a program to lower cholesterol would be impertinent, while a program to enhance the nutrition of patients in Texas by an international effort to import more grain would be ludicrous. In the same vein a public health effort to combat alcoholic cirrhosis in Mecca would be as silly as a program to increase fiber in the diet of the Bantu. Clinical communication must acknowledge the culture of the issue at hand and the differences in the experiential base of the physicians. Not only do geography and culture affect the potential differences in the experiential bases, but the world utilizes very different traditions of education and science in training physicians. We are influenced by the diseases we treat, and learn to look for the expected at least as much as we are attentive to the unexpected. A physician in Siberia would be much more likely to recognize frostbite than one from Buenos Aires, and the Argentine doctor would much more likely consider Chaga's Disease to explain abdominal pain than a colleague in Zurich. Beyond these obvious issues in communication among physicians we must deal with the many languages and idioms used in the world. An overview of using Telemedicine SpaceBridge after the earthquake in the Republic of Armenia in 1988 is presented.
Kleijnen, J; Knipschild, P; ter Riet, G
OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800
Starzl, Thomas E.
The emergence of transplantation has seen the development of increasingly potent immunosuppressive agents, progressively better methods of tissue and organ preservation, refinements in histocompatibility matching, and numerous innovations in surgical techniques. Such efforts in combination ultimately made it possible to successfully engraft all of the organs and bone marrow cells in humans. At a more fundamental level, however, the transplantation enterprise hinged on two seminal turning points. The first was the recognition by Billingham, Brent, and Medawar in 1953 that it was possible to induce chimerism-associated neonatal tolerance deliberately. This discovery escalated over the next 15 years to the first successful bone marrow transplantations in humans in 1968. The second turning point was the demonstration during the early 1960s that canine and human organ allografts could self-induce tolerance with the aid of immunosuppression. By the end of 1962, however, it had been incorrectly concluded that turning points one and two involved different immune mechanisms. The error was not corrected until well into the 1990s. In this historical account, the vast literature that sprang up during the intervening 30 years has been summarized. Although admirably documenting empiric progress in clinical transplantation, its failure to explain organ allograft acceptance predestined organ recipients to lifetime immunosuppression and precluded fundamental changes in the treatment policies. After it was discovered in 1992 that long-surviving organ transplant recipients had persistent microchimerism, it was possible to see the mechanistic commonality of organ and bone marrow transplantation. A clarifying central principle of immunology could then be synthesized with which to guide efforts to induce tolerance systematically to human tissues and perhaps ultimately to xenografts. PMID:10833242
Miralles, M; Giménez, A; Cairols, M A; Riambau, V; Sáez, A
It is the purpose of this report to focus attention on the clinical usefulness of Renal Duplex for the diagnosis of patients with vasculo-renal diseases in terms of: 1. Accuracy of Duplex/Angiography in the measurement of the renal stenosis degree. 2. Correlationship between Duplex ans Isotopic Renogram with respect to the study of the parenchyma's perfusion. 3. The effect of the inhibitors of the conversor enzyme (Captopril) on the Doppler signal of the parenchyma, comparing it with the results from the captopril test about the peripheral plasmatic renin activity and the isotopic renogram, in patients with vasculo-renal HTA. Results obtains by Duplex and Angiography were compared in 92 renal arteries from 46 patients. For both technics, three degrees of stenosis were established: 0-59%, 60-99% and occlusion. The Duplex technique identified 49/54 stenosis < 60%, 28/33 stenosis > 60% and 5/5 occlusions (Kappa 0.8). Sensibility and specificity of Duplex for the diagnosis of stenosis > 60% were, respectively, 89.5% and 90.7%; with an exactness of 90.2%. The angiographies showed stenosis > 60% in 23 patients with HTA (diastolic pressures > 100 mmHg). In all of the patients, a measurement of the plasmatic renin activity, an isotopic renogram and a Doppler of the interlobar arteries basal and post-captopril, were performed. The correlationship between Duplex and isotopic renogram with respect to the measurement of the relative renal perfusion was statistically significant (r = 0.91; p < 0.0001). The captopril test for renin and isotopic renogram were positives for 5 patients (4 with unilateral stenosis an 1 with bilateral stenosis). All of them showed severe stenosis (> 80%).(ABSTRACT TRUNCATED AT 250 WORDS)
Yu, George C.; Lee, David B. N.
Deranged phosphorus metabolism is commonly encountered in clinical medicine. Disturbances in phosphate intake, excretion and transcellular shift account for the abnormal serum levels. As a result of the essential role played by phosphate in intracellular metabolism, the clinical manifestations of hypophosphatemia and hyperphosphatemia are extensive. An understanding of the pathophysiology of various phosphate disorders is helpful in guiding therapeutic decisions. Images PMID:3321712
This article builds on a previous one which discussed the use of de Bono's thinking tool, 'six thinking hats' in the clinical, managerial, educational and research areas of nursing (Lewis 1995). This article explores clinical supervision and describes how the six thinking hats may be used as a reflective tool in the supervision of nurse lecturers who teach counselling skills.
This manual contains information concerning the policies and procedures of the Southern Illinois University-Carbondale Dental Hygiene Clinic. The manual is presented in a question/answer format for the information and convenience of dental hygiene students in the program, and is intended to answer their questions concerning clinical policies and…
3. D. (1983). The reliability of psychiatric and psycho- logical diagnosis. Clinical Psychology Review , 3, 103-145. McCord, J. (1979). Some child...patients. Clinical Psychology Review , 4, 379-401. New Jersey v. Krol, 344 A .2d 289 (1975). Newton, C., & Zimring, F. (1970). Firearms and violence in
Whitford, Betty Lou; Villaume, Susan Kidd
In this article, we explore how teacher preparation programs have developed from the mid-1800s to present day, emphasizing changes in the clinical component. Drawing from the history of teacher education from the normal schools of the 19th century to present-day interest in clinically based preparation, we first review the migration of teacher…
Kessler, C. )
This book presents papers on the clinical applications of radiolabelled platelets. The papers are grouped into six sections on platelet labelling techniques, radiolabelled platelets in cardiology, monitoring of antiplatelet therapy, platelet scintigraphy in stroke patients, platelet scintigraphy in angiology, and platelet scintigraphy in hematology and other clinical applications, including renal transplant rejection.
This conceptual paper introduces a clinical collaboration model for counselors founded in the principles of humanistic counseling and wellness. The article offers applications for client life self-assessment and the discovery of personally relevant social resources. Finally, implications of this approach for graduate training, clinical service and…
Mackay, B J; Anderson, J; Harding, T
Technology is having a profound effect on education in the 21st century and nurse educators are being challenged to integrate technological innovation to assist students in their learning. This paper reports a study on the introduction of smart mobile technology to support student learning in the clinical environment. In a climate of collaborative inquiry, clinical lecturers and two researchers from the same department carried out a project in three phases: formation, implementation and analysis. Following the formation phase, six clinical lecturers adopted iPads to support their clinical teaching (implementation phase). At this time they also kept reflective journals. In the analysis phase a thematic analysis of the data from the journals and from a focus group found both enabling and constraining factors influenced the use of iPads by clinical lecturers. The themes categorised as enablers were: resources and technology; and, management and technology support. Those identified as barriers or constraining factors were: clinical staff engagement; and lecturer experience with technology. Student engagement and learning, and connectivity were both enabling and constraining factors. This paper concludes that the use of a mobile device such as an iPad can enhance teaching in clinical settings but that in order for such devices to be successfully integrated into clinical teaching consideration needs to be given to professional development needs, adequate resourcing and technology support.
Jarfaut, A; Nivoix, Y; Vigouroux, D; Kehrli, P; Gaudias, J; Kempf, J-F; Levêque, D; Gourieux, B
Clinical pharmacy has been developed and evaluated in various medical hospital activities. Reviews conducted in this area reported a higher value of this discipline. In surgical services, evenly adverse drug events may occur, so clinical pharmacy activities must also help to optimize the management of drug's patient. The objectives of this literature review is to determine the profile of clinical pharmacy activities developed in surgical services and identify indicators. The research was conducted on Pubmed(®) database with the following keywords (2000-2013), "surgery", "pharmacy", "pharmacist", "pharmaceutical care", "impact" and limited to French or English papers. Studies dealing on simultaneously medical and surgical areas were excluded. Twenty-one papers were selected. The most frequently developed clinical pharmacy activities were history and therapeutic drug monitoring (antibiotics or anticoagulants). Two types of indicators were identified: activity indicators with the number of pharmaceutical interventions, their description and clinical signification, the acceptance rate and workload. Impact indicators were mostly clinical and economic impacts. The development of clinical pharmacy related to surgical patients is documented and appears to have, as for medical patients, a clinical and economical value.
WARD, TED W.
THE RATIONALE OF A CLINICAL APPROACH TO RESEARCH ON TEACHER BEHAVIOR IS SET FORTH TOGETHER WITH INDICATION OF DIFFICULTIES. IN ONE CLINICAL STUDY, RECORDS OF FOCUSED OBSERVATIONS OF TEACHER BEHAVIOR WERE REVIEWED BY A SPECIALIST IN LEARNING AND A SPECIALIST IN SOCIAL PSYCHOLOGY IN RELATION TO RESEARCH FROM THESE FIELDS. TEACHER DECISIONS PROVED…
Irby, David; Rakestraw, Philip
Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)
Anderson, Eugene M.
Criteria are established for a definition of "clinical supervision" and the effectiveness of such supervisory programs in a student teaching context are considered. Two differing genres of clinical supervision are constructed: "supervision by pattern analysis" is contrasted with "supervision by performance objectives." An outline of procedural…
Data generated in all clinical trial are recorded on the data collection instrument Case report Form / Electronic Case Report Form by investigators located at various sites in various countries. In multicentric clinical trials since different investigator or medically qualified experts are from different sites / centers recording the medical term(s) uniformly is a big challenge. Medical coders from clinical data management team process these terms and perform medical coding. Medical coding is performed to categorize the medical terms reported appropriately so that they can be analyzed/reviewed. This article describes process which is used for medical coding in clinical data management and two most commonly used medical dictionaries MedDRA and WHO-DDE in brief. It is expected to help medical coders to understand the process of medical coding in clinical data management. Few common issues which the medical coder faces while performing medical coding, are also highlighted.
Gómez Velásquez, Luis; Gómez Espinosa, Luis Néstor
The scientific and technological advances have been surprising, more in the two last decades, but they don't go united with to the ethical values of the medical professional practice, it has been totally escaped, specially when the biological subsistence, the maintenance of the life through apparatuses and the mechanisms that prolong the existence are who undergoes an alteration that until recently time was mortal shortly lapse. It is common listening that exist a crisis in the medical profession, but what really is it of human values, which as soon and taken into nowadays, actually professional account, which gives rise to a dehumanization towards the life, the health, the disease, the suffering and the death. The ideal of the doctor to give to service to the man in its life and health, as well to be conscious that the last biological process that must fulfill is the death, and when it appears, does not have considered as a actually professional failure. It has protect to the patient as the extreme cruelty therapeutic, that it has right a worthy death. It's taking to the birth of the hospital ethics committees, they have like function to analyze, to advise and to think about the ethical dilemmas that appear actually clinical or in the biomedical investigation. In 1982 in the UEA only 1% of its hospitals had a ethics committees; by 1988, it was 67% and the 100% in 2000. In Mexico the process of the formation by these committees begins, only in the Military Central Hospital, to count the ethics committee on 1983, also the Hospital no. 14 of the IMSS in Guadalajara, it works with regularity from 1995, with internal teaching of bioethic. The Secretariat of Health has asked the formation of the bioethical committees in each hospital, and order the it was be coordinated by the National Committee of Bioética. The integration of these committees is indispensable that their members have the knowledge necessary of bioética. The Mexican Society of Ortopedia, conscious of
INTRODUCTION: NASA's Space Medicine community knowledge regarding the "Vision Impairment Intracranial Pressure", or VIIP.has been evolving over time.. Various measures of occupational health related to this condition had to be determined and then plans/processes put into place. The most robust of these processes were inititated in 2010. This presentation will provide a clinic update of the astronaut occupational health data related to VIIP. METHODS: NASA and its international partners require its astronauts to undergo routine health measures deemed important to monitoring VIIP. The concern is that the spaceflight environment aboard ISS could cause some astronauts to have physiologic changes detrimental to either ongoing mission operations or long-term health related to the ocular system and possibly the CNS. Specific medical tests include but are not limited to brain/orbit MRI (NASA unique protocol), OCT, fundoscopy and ocular ultrasound. Measures are taken prior to spaceflight, in-flight and post-flight. Measures to be reported include incidence of disc edema, globe flattening, choroidal folds, ONSD and change in refractive error. RESULTS: 73 ISS astronauts have been evaluated at least partially for VIIP related measures. Of these individuals, approximately 1 in 7 have experienced disc edema. The prevalence of the other findings is more complicated as the medical testing has changed over time. Overall, 26 separate individuals have experienced at least one of the findings NASA has associated with VIIP Another confounding factor is most of the astronauts have prior spaceflight experience at the time of the "pre-flight" testing. DISCUSSION: In 2010 NASA and its US operating segment (USOS) partners (CSA, ESA and JAXA) began routine occupational monitoring and data collection for most VIIP related changes. Interpretation of that data is extremely challenging for several reasons. For example, the determination of disc edema is the most complete finding as we have had
Zwarts, M J; Bleijenberg, G; van Engelen, B G M
reliability of the psychological and clinical neurophysiological assessment techniques available today allows a multidisciplinary approach to fatigue in neurological patients, which may contribute to the elucidation of the pathophysiological mechanisms of chronic fatigue, with the ultimate goal to develop tailored treatments for fatigue in neurological patients. The present report discusses the different manifestations of fatigue and the available tools to assess peripheral and central fatigue.
Meeker-O’Connell, Ann; Glessner, Coleen; Behm, Mark; Mulinde, Jean; Roach, Nancy; Sweeney, Fergus; Tenaerts, Pamela; Landray, Martin J
Background: Stakeholders across the clinical trial enterprise have expressed concern that the current clinical trial enterprise is unsustainable. The cost and complexity of trials have continued to increase, threatening our ability to generate reliable evidence essential for making appropriate decisions concerning the benefits and harms associated with clinical interventions. Overcoming this inefficiency rests on improving protocol design, trial planning, and quality oversight. Methods: The Clinical Trials Transformation Initiative convened a project to evaluate methods to prospectively build quality into the scientific and operational design of clinical trials (“quality-by-design”), such that trials are feasible to conduct and important errors are prevented rather than remediated. A working group evaluated aspects of trial design and oversight and developed the Clinical Trials Transformation Initiative quality-by-design principles document, outlining a series of factors generally relevant to the reliability of trial conclusions and to patient safety. These principles were then applied and further refined during a series of hands-on workshops to evaluate their utility in facilitating proactive, cross-functional dialogue, and decision-making about trial design and planning. Following these workshops, independent qualitative interviews were conducted with 19 workshop attendees to explore the potential challenges for implementing a quality-by-design approach to clinical trials. The Clinical Trials Transformation Initiative project team subsequently developed recommendations and an online resource guide to support implementation of this approach. Conclusion: The Clinical Trials Transformation Initiative quality-by-design principles provide a framework for assuring that clinical trials adequately safeguard participants and provide reliable information on which to make decisions on the effects of treatments. The quality-by-design workshops highlighted the value of
Wing, Rena R.
Look AHEAD was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow up of 9.6 years was not reduced in the intensive lifestyle group relative to the control group. This finding is discussed, with emphasis on its implications for design of clinical trials and clinical treatment of obese people with type 2 diabetes. PMID:24853636
Rooksby, J; Kay, S
Radiology reports, as a form of clinical narrative, are more than a repository of patient information but are active in patient care. They are not unique and individual to each patient but have structured content suitable for supporting the activities of care. We consider these activities of care and how they manifest in the report. This recognition of the infusion of clinical organisation in clinical narrative leads to the recognition of seven properties of radiology reports: labels, concepts, genre, structure, author, subject, reader. These properties exist across two relationships: the intertextual relationship between radiology reports and the interpersonal relationship between a radiology report and people.
Abad Rico, José Ignacio; Lozano Sánchez, Francisco S; Rocha, Eduardo
therapy, while bleeding complications over 3 months of therapy were similarly low. In a European study, acute treatment of DVT with bemiparin for one week followed by 12 weeks' secondary prevention with bemiparin (i.e. bemiparin/bemiparin) was associated with a cost saving of &U20AC;908 per patient compared with UFH/warfarin. Similarly, bemiparin/warfarin produced a cost saving of &U20AC;769 compared with UFH/warfarin. The savings were predominantly the result of reduced hospital stays during acute treatment with bemiparin. Bemiparin was also associated with increased quality-adjusted life expectancy. Observational studies in routine clinical practice demonstrated that outpatient treatment of acute VTE was as effective as inpatient treatment, but with lower costs, and bemiparin was as effective as vitamin K antagonists over 3 months for secondary prevention, with VTE recurrence rates of 0% and 0.3% over 3 months in separate studies. Bemiparin is thus an effective, well tolerated agent for thromboprophylaxis in surgery, and for the acute and long-term treatment of established VTE, having advantages over UFH and particular benefits as a result of initiating therapy postoperatively.
Miller, Franklin G
Clinical research with patient-subjects was routinely conducted without informed consent for research participation prior to 1966. The aim of this article is to illuminate the moral climate of clinical research at this time, with particular attention to placebo-controlled trials in which patient-subjects often were not informed that they were participating in research or that they might receive a placebo intervention rather than standard medical treatment or an experimental treatment for their condition. An especially valuable window into the thinking of clinical investigators about their relationship with patient-subjects in the era before informed consent is afforded by reflection on two articles published by psychiatric researchers in 1966 and 1967, at the point of transition between clinical research conducted under the guise of medical care and clinical research based on consent following an invitation to participate and disclosure of material information about the study. Historical inquiry relating to the practice of clinical research without informed consent helps to put into perspective the moral progress associated with soliciting consent following disclosure of pertinent information; it also helps to shed light on an important issue in contemporary research ethics: the conditions under which it is ethical to conduct clinical research without informed consent.
Geoghegan, J; Pappas, T N
OBJECTIVE: The authors review clinical applications of gut-derived peptides as diagnostic and therapeutic agents. SUMMARY BACKGROUND DATA: An increasing number of gut peptides have been evaluated for clinical use. Earlier uses as diagnostic agents have been complemented more recently by increasing application of gut peptides as therapeutic agents. METHOD: The authors conducted a literature review. RESULTS: Current experience with clinical use of gut peptides is described. Initial clinical applications focused on using secretomotor effects of gut peptides in diagnostic tests, many of which have now fallen into disuse. More recently, attention has been directed toward harnessing these secretomotor effects for therapeutic use in a variety of disorders, and also using the trophic effects of gut peptides to modulate gut mucosal growth in benign and malignant disease. Gut peptides have been evaluated in a variety of other clinical situations including use as adjuncts to imaging techniques, and modification of behaviors such as feeding and panic disorder. CONCLUSIONS: Gut peptides have been used successfully in an increasing variety of clinical conditions. Further refinements in analogue and antagonist design are likely to lead to even more selective agents that may have important clinical applications. Further studies are needed to identity and evaluate these new agents. PMID:9065291
Thompson, Michael A
Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.
Alarcão, Violeta; Ribeiro, Sofia; Almeida, Joana; Giami, Alain
Few studies explore the clinicians' knowledge, attitudes, and practices regarding sexuality, despite their role in the sexual-health socialization process. This study focuses on Portuguese sexologists engaged in clinical practice. It aims to characterize sexologists' sex education and training and their clinical practices, including diagnostic and therapeutic approaches. This research followed the methodology of an European survey on sexology as a profession (Euro-Sexo). From the 91 respondents who completed questionnaires, 51 (56%) were active in clinical practice. Results indicate that the Portuguese clinical sexologist is significantly older, predominantly male, has had training in sexology, performs more scientific research, and is more engaged in teaching activities when compared to nonclinical working sexologists. This article describes the main sexual problems presented by patients to Portuguese clinical sexologists and highlights differences in the professional groups and approaches toward treating these problems by medical doctors and nonmedical professionals. Results reinforce the idea that there are intra-European differences in the educational background of sexologists and reveal important variations in Portuguese sexologists' education, training, and clinical practice. The representations and practices of the sexologists in Portugal, as in other European countries, are embedded in cultural scenarios and sexual cultures, with implications for the clinical practice.
Scott, Stuart A.
Clinical genetic testing has grown substantially over the past 30 years as the causative mutations for Mendelian diseases have been identified, particularly aided in part by the recent advances in molecular-based technologies. Importantly, the adoption of new tests and testing strategies (e.g., diagnostic confirmation, prenatal testing, and population-based carrier screening) has often been met with caution and careful consideration before clinical implementation, which facilitates the appropriate use of new genetic tests. Although the field of pharmacogenetics was established in the 1950s, clinical testing for constitutional pharmacogenetic variants implicated in interindividual drug response variability has only recently become available to help clinicians guide pharmacotherapy, in part due to US Food and Drug Administration-mediated product insert revisions that include pharmacogenetic information for selected drugs. However, despite pharmacogenetic associations with adverse outcomes, physician uptake of clinical pharmacogenetic testing has been slow. Compared with testing for Mendelian diseases, pharmacogenetic testing for certain indications can have a lower positive predictive value, which is one reason for underutilization. A number of other barriers remain with implementing clinical pharmacogenetics, including clinical utility, professional education, and regulatory and reimbursement issues, among others. This review presents some of the current opportunities and challenges with implementing clinical pharmacogenetic testing. PMID:22095251
Hasanjani Roushan, Mohammad Reza; Ebrahimpour, Soheil; Moulana, Zahra
Background Brucellosis is one of the important multi-organ zoonotic infectious diseases. The forms of the clinical course of brucellosis in humans are acute, sub-acute and chronic. Objectives The present study aimed to retrospectively analyze the clinical characteristics and complications in the clinical forms of human brucellosis in Iran. Patients and Methods The population included 957 patients admitted in the infectious diseases clinic affiliated to Babol University of Medical Sciences, Babol, Iran, within the past two decades. Data for the patients were obtained and documented in questionnaires. Patients were divided into three groups according to their history, symptoms and clinical presentation time: acute (0 - 2 months), sub-acute (3 - 12 months), and chronic (> 1 year). Results Most of the patients (73.8%) were in the acute stages of brucellosis, 22.6% had sub-acute brucellosis and 3.7% had chronic brucellosis. The most frequently observed symptoms were arthralgia (71%), sweating (66.7%), fever (57.2%) and backache (39.3%). The most common complication was arthritis (13.2%) in this study. Conclusions This infection was observed with a diversity of clinical manifestations. Therefore, diagnostic difficulty because of the various clinical presentations and the way to find undiagnosed complications should be investigated in the differential diagnosis of other diseases. PMID:27284398
Background: Clinical reasoning has long been a valuable tool for health care practitioners, but it has been under-researched in the field of massage therapy. Case reports have been a useful method for exploring the clinical reasoning process in various fields of manual therapy and can provide a model for similar research in the field of massage therapy. A diagnostically challenging case concerning a client with low back pain serves as a guideline for examining the clinical reasoning process of a massage therapist. Methods: A two-part methodology was employed: Client profileReflective inquiry The inquiry included questions pertaining to beliefs about health problems; beliefs about the mechanisms of pain; medical conditions that could explain the client’s symptoms; knowledge of the client’s anatomy, assessment, and treatment choices; observations made during treatment; extent of experience in treating similar problems; and ability to recognize clinical patterns. Results: The clinical reasoning process of a massage therapist contributed to a differential diagnosis, which provided an explanation for the client’s symptoms and led to a satisfactory treatment resolution. Conclusion: The present report serves as an example of the value of clinical reasoning in the field of massage therapy, and the need for expanded research into its methods and applications. The results of such research could be beneficial in teaching the clinical reasoning process at both the introductory and the advanced levels of massage therapy education. PMID:21589814
Peters, Sanne A E; Groenwold, Rolf H H; Bots, Michiel L
An intermediate variable such as blood pressure is part of the causal pathway of mechanisms to a clinical outcome, e.g. myocardial infarction. An intervention affects a clinical outcome through its effect on that intermediate variable. In studies designed to assess the effects of interventions an intermediate variable may be used as surrogate for clinical outcomes. Such an endpoint is also known as an intermediate endpoint. Intervention studies with intermediate endpoints are commonly performed in medical research to evaluate the effects of an intervention on clinical outcomes. Intervention studies with an intermediate endpoint are conducted in a smaller study population and with a shorter duration of follow-up than studies using clinical outcomes. An intermediate variable is not eligible as an intermediate endpoint when the intervention also affects other biological mechanisms that subsequently affect the clinical endpoint. Due to a smaller sample size and shorter study duration, side effects of intervention are more difficult to evaluate in studies with an intermediate endpoint than in studies with clinical endpoints.
Goracci, Arianna; Casamassima, Francesco; Iovieno, Nadia; di Volo, Silvia; Benbow, Jim; Bolognesi, Simone; Fagiolini, Andrea
This case report describes the clinical course of a young woman suffering from binge eating disorder (BED) associated with obesity. It illustrates the efficacy of different medications in the treatment of BED and related conditions and is followed by the comments and clinical observations of 2 practicing psychiatrists. The issues described in this paper have important clinical implications and are topical, given that BED is now recognized as a specific disorder in the new Diagnostic and Statistical Manual of Mental Disorders, fifth edition classification system, but neither the US Food and Drug Administration nor any other regulatory agency has yet approved a drug for treatment of this disease, despite its very prevalent and disabling nature. Growing evidence from the fields of psychopathology and neurobiology, including preclinical and clinical studies, converges to support the idea that "overeating" has much in common with other behavioral addictions, and substance abuse treatment agents may show promise for the treatment of BED.
Hooper, J; O'Connor, J; Cheesmar, R; Price, C P
We have developed computer-based clinical case histories incorporating multimedia elements to aid the learning of medicine in a problem-based manner. Topics have been developed in the specialty of Clinical Biochemistry but the approach used is suitable for any branch of clinical medicine. Each topic has material aimed at medical students and also postgraduate candidates for professional examinations. A browser program is also incorporated. Emphasis is made on interaction through the case and modeling of real-life decisions in diagnosis and treatment. Advantages of the program are self-paced learning, assessment of understanding, feedback, and emphasis on deep understanding of the basic physiological and biochemical processes underlying clinical problems.
... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a ...
Photoacoustic imaging is a hybrid technique that shines laser light on tissue and measures optically induced ultrasound signal. There is growing interest in the clinical community over this new technique and its possible clinical applications. One of the most prominent features of photoacoustic imaging is its ability to characterize tissue, leveraging differences in the optical absorption of underlying tissue components such as hemoglobin, lipids, melanin, collagen and water among many others. In this review, the state-of-the-art photoacoustic imaging techniques and some of the key outcomes pertaining to different cancer applications in the clinic are presented. PMID:27669961
Targum, Steven D.
Objective: This paper reviews the potential value in daily clinical practice of an easily applied research tool, the Clinical Global Impressions (CGI) Scale, for the nonresearcher clinician to quantify and track patient progress and treatment response over time. Method: The instrument is described and sample patient scenarios are provided with scoring rationales and a practical charting system. Conclusion: The CGI severity and improvement scales offer a readily understood, practical measurement tool that can easily be administered by a clinician in a busy clinical practice setting. PMID:20526405
George, Stephen L; Buyse, Marc
Highly publicized cases of fabrication or falsification of data in clinical trials have occurred in recent years and it is likely that there are additional undetected or unreported cases. We review the available evidence on the incidence of data fraud in clinical trials, describe several prominent cases, present information on motivation and contributing factors and discuss cost-effective ways of early detection of data fraud as part of routine central statistical monitoring of data quality. Adoption of these clinical trial monitoring procedures can identify potential data fraud not detected by conventional on-site monitoring and can improve overall data quality. PMID:25729561
Clinically isolated syndrome (CIS) is a term that describes the first clinical onset of potential multiple sclerosis (MS). The term CIS is typically applied to young adults with episodes of acute or subacute onset, which reaches a peak quite rapidly within 2–3 weeks. In 85% of young adults who develop MS, onset occurs with an acute, CIS of the optic nerves, brainstem, or spinal cord. When clinically silent brain lesions are seen on MRI, the likelihood of developing MS is high. Because no single clinical feature or diagnostic test is sufficient for the diagnosis of CIS, diagnostic criteria have included a combination of both clinical and paraclinical studies. Diagnostic criteria from the International Panel of McDonald and colleagues incorporate MRI evidence of dissemination in time and space to allow a diagnosis of definite MS in patients with CIS. As CIS is typically the earliest clinical expression of MS, research on patients with CIS may provide new insights into early pathological changes and pathogenetic mechanisms that might affect the course of the disorder. With recent improvements in diagnosis and the advent of disease-modifying treatments for MS, there has been growing interest and research in patients with CIS.
Vijay, Priyanka; McIntyre, Alexa B R; Mason, Christopher E; Greenfield, Jeffrey P; Li, Sheng
Next-generation sequencing (NGS) approaches are highly applicable to clinical studies. We review recent advances in sequencing technologies, as well as their benefits and tradeoffs, to provide an overview of clinical genomics from study design to computational analysis. Sequencing technologies enable genomic, transcriptomic, and epigenomic evaluations. Studies that use a combination of whole genome, exome, mRNA, and bisulfite sequencing are now feasible due to decreasing sequencing costs. Single-molecule sequencing increases read length, with the MinIONTM nanopore sequencer, which offers a uniquely portable option at a lower cost. Many of the published comparisons we review here address the challenges associated with different sequencing methods. Overall, NGS techniques, coupled with continually improving analysis algorithms, are useful for clinical studies in many realms, including cancer, chronic illness, and neurobiology. We, and others in the field, anticipate the clinical use of NGS approaches will continue to grow, especially as we shift into an era of precision medicine.
In the setting of clinical medical education, feedback refers to information describing students' or house officers' performance in a given activity that is intended to guide their future performance in that same or in a related activity. It is a key step in the acquisition of clinical skills, yet feedback is often omitted or handled improperly in clinical training. This can result in important untoward consequences, some of which may extend beyond the training period. Once the nature of the feedback process is appreciated, however, especially the distinction between feedback and evaluation and the importance of focusing on the trainees' observable behaviors rather than on the trainees themselves, the educational benefit of feedback can be realized. This article presents guidelines for offering feedback that have been set forth in the literature of business administration, psychology, and education, adapted here for use by teachers and students of clinical medicine.
Batista, Pollyanna Barros; Bertollo, Eny Maria Goloni; Costa, Danielle de Souza; Eliam, Lucas; Cunha, Karin Soares Gonçalves; Cunha-Melo, José Renan; Darrigo Junior, Luiz Guilherme; Geller, Mauro; Gianordoli-Nascimento, Ingrid Faria; Madeira, Luciana Gonçalves; Mendes, Hérika Martins; Miranda, Débora Marques de; Mata-Machado, Nikolas Andre; Morato, Eric Grossi; Pavarino, Érika Cristina; Pereira, Luciana Baptista; Rezende, Nilton Alves de; Rodrigues, Luíza de Oliveira; Sette, Jorge Bezerra Cavalcanti
Part 1 of this guideline addressed the differential diagnosis of the neurofibromatoses (NF): neurofibromatosis type 1 (NF1), neurofibromatosis type 2 (NF2) and schwannomatosis (SCH). NF shares some features such as the genetic origin of the neural tumors and cutaneous manifestations, and affects nearly 80 thousand Brazilians. Increasing scientific knowledge on NF has allowed better clinical management and reduced rate of complications and morbidity, resulting in higher quality of life for NF patients. Most medical doctors are able to perform NF diagnosis, but the wide range of clinical manifestations and the inability to predict the onset or severity of new features, consequences, or complications make NF management a real clinical challenge, requiring the support of different specialists for proper treatment and genetic counseling, especially in NF2 and SCH. The present text suggests guidelines for the clinical management of NF, with emphasis on NF1.
Scientists from NCI, together with collaborators from outside academic centers, have developed a checklist of criteria to evaluate the readiness of complex molecular tests that will guide decisions made during clinical trials. The checklist focuses on tes
Heins, Paul J.; Mackenzie, Richard S.
An adaptation of the inquiry method of teaching, which develops skills of information retrieval and reasoning through systematic questioning by the teacher, is proposed for instruction in clinical periodontics. (MSE)
Refolo, P; Sacchini, D; Minacori, R; Spagnolo, A G
Recruiting patients is a critical point of today's clinical research and, along the years, several solutions have been proposed, even if their efficacy seems to be doubtful. On the other hand, nowadays, Internet represents a great opportunity for improving clinical trial recruitments. Nevertheless, on-line recruitment services (e-recruitment) could ensure some advantages (such as facilitating interaction between supply and demand of clinical research, time and money savings/optimizations, data entry errors reduction), but also raise some issues (such as those related to sampling, information, consent, real identity of participants and risks for data breaches). The article debates on the difficulties to recruit patients for clinical research, in general, and e-recruitment particularly, discussing some ethical issues raised by internet enrolment.
Draganov, V; Nikolov, R; Lazarov, S
Members of macrolides are Erythromycin, Oleandomycin, Spiramycin, Roxithromycin, Josamycin, Midecamycin, Clarithromycin, Azithromycin and Dirithromycin. This review present mechanism of action, pharmacokinetic, adverse drug reactions and main clinical uses of the macrolides.
Sander, Rebecca; Trible, Karen A
Two years ago, faculty and students at this rural university setting collaborated to implement a virtual clinical evaluation tool. In recognition of the frustrations involved in coordinating instructor and student input to a hard copy tool, a virtual clinical evaluation tool was created in the form of an Excel spreadsheet. Excel documents have the advantage of immediate retrieval and use by instructors or students, ease of narration by word processing, automatic mathematical computation of formative and summative scores, and data storage through computer archives. Using the online Blackboard course, students and instructors are able to collaboratively input a Likert score for each posted evaluation outcome and word process-related comments about students' clinical performance. An overview of the 2-year implementation of this virtual clinical evaluation tool, as well as the evaluation process, is discussed.
Groll, Andreas H; Gea-Banacloche, Juan C; Glasmacher, Axel; Just-Nuebling, Gudrun; Maschmeyer, Georg; Walsh, Thomas J
Prompted by the worldwide surge in fungal infections, the past decade has witnessed a considerable expansion in antifungal drug research. New compounds have entered the clinical arena, and major progress has been made in defining paradigms of antifungal therapies. This article provides an up-to-date review on the clinical pharmacology, indications, and dosage recommendations of approved and currently investigational therapeutics for treatment of invasive fungal infections in adult and pediatric patients.
Bonifati, C; Berardesca, E
Several tools have been introduced in clinical trials to quantify the severity and the response to a given therapeutic regimen of both psoriasis and psoriatic arthritis. Each method present specific advantages and limitations. Here we will discuss some of the most popular clinical outcome measures of both psoriasis (Psoriasis Severity Index, Physician Global Assessment, National Psoriasis Fundation-Psoriasis Score, Dermatology Life Quality Index) and psoriatic arthritis (American College Rheumatology response criteria, Psoriatic Arthritis Response Criteria).
This was an award to purchase equipment for state-of-the-art MRI radiofrequency coils. There was no personnel effort or construction as a part of this project. This report details the final status of the approved budget items for this project. All approved budget items were successfully delivered and installed. The equipment provided to Cleveland Clinic under this project will allow Cleveland Clinic researchers to build imaging equipment with improved capability to investigate brain disorders.
ADDRESS(ES) 8. PERFORMING ORGANIZATION REPORT NUMBER Cleveland Clinic Foundation 9500 Euclid Ave Cleveland, Ohio 44195 9. SPONSORING / MONITORING AGENCY...Foundation. There are no plans to add another site. Investigational Site Investigators Cleveland Clinic Foundation 9500 Euclid Avenue, Cleveland...PI: Ela Plow PhD PT 9500 Euclid Ave CLEVELAND, OHIO 44106 CONTACT PERSON: Ela Plow PhD PT PHONE: (216)-445-4589 FAX: (216) 445-6083 E-MAIL
Objectives: In recent years, there has been a decline in estimated time spent on bedside teaching. The aim of this study was to evaluate clinical teachers’ perceptions and practice of, and approaches to, bedside teaching. Methods: The study site was Ninewells Hospital in Dundee, UK. A self-administered questionnaire was developed and piloted on full-time clinical academic university staff. Responses were solicited to 36 questions relating to teaching experience, familiarity with the 12 learning outcomes of Dundee Medical School's curriculum, and perception and practice of basic bedside etiquette. For each of these items, a comparison between consultants and specialist registrars (SPRs) was carried out. Results: Out of the 64 clinical teachers approached, 45 (70%) participated in the study: 26 of them (57.7%) were consultants and 19 (42.3%) SPRs. A total of 17 (65%) of the consultants had been trained to teach medical students at the bedside, while only 9 SPRs (47%) had had similar training. In addition, 13 consultants (50%) reported being familiar with Dundee Medical School's 12 learning outcomes, while only 7 (36%) SPRs were familiar with it. Obstacles reported by consultants and SPRs were groups of over 6 students (65% versus 61%, respectively), a limited number of patients with good clinical signs (67% versus 63%, respectively), a shorter length of stay in hospital (73% versus 68%, respectively), lack of privacy in crowded wards (76% versus 73%, respectively), and interruptions from telephones and visitors (57% versus 64%, respectively). Conclusion: Effective clinical teacher training and a thorough understanding of curriculum outcomes are crucial to successful bedside clinical teaching. Identifying obstacles to bedside clinical teaching will contribute to a more effective and efficient programme. PMID:23573392
Hunsberger, Peter Hume
Comments on the report by the APA Presidential Task Force on Evidence-Based Practice entitled Evidence-based practice in psychology. The Task Force is to be commended for their report valuing evidence from "clinical expertise" on a par with "research data" (p. 272) in guiding psychological practices. The current author suggests that the APA not only should make a place at psychology's policy making table for "clinical expertise" but should prioritize clinical and subjective sources of data -- the essence of the psychological -- and set policies to ensure that objective data, such as behaviors and DSM diagnoses, are considered in their subjective context. The APA should also encourage researchers to devise ways to preserve as much as possible the personal "feel" of the clinical encounter in their data analysis and published conclusions. The APA also needs to assign priority to subjective emotional and relational skills on a par with academic and analytic skills in the selection and training of clinical psychology students. Reconnecting clinical psychology with its subjective evidentiary roots in ways such as these should help to bring us out from under the dominance of medicine, to the benefit of our profession and our clients.
Interventional oncology has great potential to be a good treatment modality in the field of oncology, because its procedures are minimally invasive and fairly quick. However, except for a few procedures such as percutaneous radiofrequency ablation and trans-catheter arterial chemo-embolization that have been recognized as standard treatments for hepatocellular carcinoma, most procedures have not been established as the standard treatment modality due to the limited number of clinical trials with compelling evidence. There are several common problems when performing clinical trials of interventional oncology. The first is that the outcomes of clinical trials are greatly influenced by the level of technical skill of the physicians. The second is that equipment and devices vary widely in countries and regions, and they also influence the outcomes. The third is that the methodology of clinical trials for techniques such as interventional oncology has not yet been established. The fourth is the difficulty of setting appropriate endpoints; quality of life is suitable for evaluating interventional oncology in palliative care, but it is not easy to set as the endpoint. The fifth is the difficulty of employing a blinded design, because the procedure cannot be performed without the physician's awareness. Despite such difficult situations, many multi-institutional clinical trials of interventional oncology have been carried out in Japan, with some challenging results. Establishing evidence is critical to making interventional oncology the standard treatment. Interventional radiologists should know the importance of clinical trials, and should move ahead in this direction in a step-by-step manner.
Uhr, Jonathan W.; Pantel, Klaus
Clinical cancer dormancy is defined as an unusually long time between removal of the primary tumor and subsequent relapse in a patient who has been clinically disease-free. The condition is frequently observed in certain carcinomas (e.g., breast cancer), B-cell lymphoma, and melanoma, with relapse occurring 5–25 y later. Clinical data suggest that a majority of breast cancer survivors have cancer cells for decades but can remain clinically cancer-free for their lifetime. Thus, there is a major effort to characterize the molecular mechanisms responsible for inducing tumor cell dormancy using experimental models or studying the early phases of cancer growth in humans. Many molecules and signaling pathways have been characterized and have led to concepts that dominate the field, such as the possible role of innate and adaptive immunity in immune surveillance and initiation and maintenance of dormancy. However, recent clinical data do not support many of these concepts. Several areas need further study to determine their relevance to clinical cancer dormancy. We suggest hypotheses that may contribute to elucidation of the mechanisms underlying the dormant state. PMID:21746894
Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.
Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352
Advancements in information, communication, and sensor technologies have led to new opportunities in medical care and education. Patients in general prefer visiting the nearest clinic, attempt to avoid waiting for treatment, and have unequal preferences for different clinics and doctors. Therefore, to enable patients to compare multiple clinics, this study proposes a ubiquitous multicriteria clinic recommendation system. In this system, patients can send requests through their cell phones to the system server to obtain a clinic recommendation. Once the patient sends this information to the system, the system server first estimates the patient's speed according to the detection results of a global positioning system. It then applies a fuzzy integer nonlinear programming-ordered weighted average approach to assess four criteria and finally recommends a clinic with maximal utility to the patient. The proposed methodology was tested in a field experiment, and the experimental results showed that it is advantageous over two existing methods in elevating the utilities of recommendations. In addition, such an advantage was shown to be statistically significant.
Stewart, J.; Beyer, B. K.; Chadwick, K.; De Schaepdrijver, L.; Desai, M.; Enright, B.; Foster, W.; Hui, J. Y.; Moffat, G. J.; Tornesi, B.; Van Malderen, K.; Wiesner, L.; Chen, C. L.
The Health and Environmental Sciences Institute (HESI) Developmental and Reproductive Toxicology Technical Committee sponsored a pharmaceutical industry survey on current industry practices for contraception use during clinical trials. The objectives of the survey were to improve our understanding of the current industry practices for contraception requirements in clinical trials, the governance processes set up to promote consistency and/or compliance with contraception requirements, and the effectiveness of current contraception practices in preventing pregnancies during clinical trials. Opportunities for improvements in current practices were also considered. The survey results from 12 pharmaceutical companies identified significant variability among companies with regard to contraception practices and governance during clinical trials. This variability was due primarily to differences in definitions, areas of scientific uncertainty or misunderstanding, and differences in company approaches to enrollment in clinical trials. The survey also revealed that few companies collected data in a manner that would allow a retrospective understanding of the reasons for failure of birth control during clinical trials. In this article, suggestions are made for topics where regulatory guidance or scientific publications could facilitate best practice. These include provisions for a pragmatic definition of women of childbearing potential, guidance on how animal data can influence the requirements for male and female birth control, evidence-based guidance on birth control and pregnancy testing regimes suitable for low- and high-risk situations, plus practical methods to ascertain the risk of drug-drug interactions with hormonal contraceptives. PMID:27042398
Montoya, Isaac D; Kimball, Olive M
Over the past decade, clinical doctorate programs in health disciplines have proliferated amid both support and controversy among educators, professional organizations, practitioners, administrators, and third-party payers. Supporters argue that the explosion of new knowledge and increasing sophistication of technology have created a need for advanced practice models to enhance patient care and safety and to reduce costs. Critics argue that necessary technological advances can be incorporated into existing programs and believe that clinical doctorates will increase health care costs, not reduce them. Despite the controversy, many health disciplines have advanced the clinical doctorate (the most recent is the doctor of nursing practice in 2004), with some professions mandating the doctorate as the entry-level degree (i.e., psychology, pharmacy, audiology, and so on). One aspect of the introduction of clinical doctoral degrees has been largely overlooked, and that is the marketing aspect. Because of marketing considerations, some clinical doctorates have been more successfully implemented and accepted than others. Marketing is composed of variables commonly known as "the four P's of marketing": product, price, promotion, and place. This report explores these four P's within the context of clinical doctorates in the health disciplines.
Garb, Howard N.; Grove, William M.
This paper presents comments on the article by D. Westen and J. Weinberger , which criticized academic clinical psychologists for being cynical about clinical judgment and clinical practice. In the authors' view, it seems unlikely that more than a few academic clinical psychologists believe that they have little to learn from clinical practice or…
Han, Yi; Stevens, Andrea L; Dashtipour, Khashayar; Hauser, Robert A; Mari, Zoltan
A systematic pair-wise comparison of all available botulinum toxin serotype A and B treatments for cervical dystonia (CD) was conducted, as direct head-to-head clinical trial comparisons are lacking. Five botulinum toxin products: Dysport(®) (abobotulinumtoxinA), Botox(®) (onabotulinumtoxinA), Xeomin(®) (incobotulinumtoxinA), Prosigne(®) (Chinese botulinum toxin serotype A) and Myobloc(®) (rimabotulinumtoxinB) have demonstrated efficacy for managing CD. A pair-wise efficacy and safety comparison was performed for all toxins based on literature-reported clinical outcomes. Multi-armed randomized controlled trials (RCTs) were identified for inclusion using a systematic literature review, and assessed for comparability based on patient population and efficacy outcome measures. The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was selected as the efficacy outcome measurement for assessment. A mixed treatment comparison (MTC) was conducted using a Bayesian hierarchical model allowing indirect comparison of the interventions. Due to the limitation of available clinical data, this study only investigated the main effect of toxin treatments without explicitly considering potential confounding factors such as gender and formulation differences. There was reasonable agreement between the number of unconstrained data points, residual deviance and pair-wise results. This research suggests that all botulinum toxin serotype A and serotype B treatments were effective compared to placebo in treating CD, with the exception of Prosigne. Based on this MTC analysis, there is no significant efficacy difference between Dysport, Botox, Xeomin and Myobloc at week four post injection. Of the adverse events measured, neither dysphagia nor injection site pain was significantly greater in the treatment or placebo groups.
Schleyer, Titus K.L.; Thyvalikakath, Thankam P.; Spallek, Heiko; Torres-Urquidy, Miguel H.; Hernandez, Pedro; Yuhaniak, Jeannie
Objective: Measure the adoption and utilization of, opinions about, and attitudes toward clinical computing among general dentists in the United States. Design: Telephone survey of a random sample of 256 general dentists in active practice in the United States. Measurements: A 39-item telephone interview measuring practice characteristics and information technology infrastructure; clinical information storage; data entry and access; attitudes toward and opinions about clinical computing (features of practice management systems, barriers, advantages, disadvantages, and potential improvements); clinical Internet use; and attitudes toward the National Health Information Infrastructure. Results: The authors successfully screened 1,039 of 1,159 randomly sampled U.S. general dentists in active practice (89.6% response rate). Two hundred fifty-six (24.6%) respondents had computers at chairside and thus were eligible for this study. The authors successfully interviewed 102 respondents (39.8%). Clinical information associated with administration and billing, such as appointments and treatment plans, was stored predominantly on the computer; other information, such as the medical history and progress notes, primarily resided on paper. Nineteen respondents, or 1.8% of all general dentists, were completely paperless. Auxiliary personnel, such as dental assistants and hygienists, entered most data. Respondents adopted clinical computing to improve office efficiency and operations, support diagnosis and treatment, and enhance patient communication and perception. Barriers included insufficient operational reliability, program limitations, a steep learning curve, cost, and infection control issues. Conclusion: Clinical computing is being increasingly adopted in general dentistry. However, future research must address usefulness and ease of use, workflow support, infection control, integration, and implementation issues. PMID:16501177
Ogawa, Hisao; Kojima, Sunao
"Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".
... Clinical Trials Clinical Trials, A Healthier Future for All Past Issues / Fall 2016 Table of Contents Did ... be harmed by, the treatment. Most, but not all, clinical trials in the U.S. are approved and ...
... and effective in people. What is an HIV/AIDS clinical trial? HIV/AIDS clinical trials help researchers ... to HIV Can anyone participate in an HIV/AIDS clinical trial? It depends on the study. Some ...
Wing, R R
Look AHEAD (Action for Health in Diabetes) was a randomized clinical trial designed to examine the long-term health effects of weight loss in overweight and obese individuals with type 2 diabetes. The primary result was that the incidence of cardiovascular events over a median follow-up of 9.6 years was not reduced in the Intensive Lifestyle Group relative to the control group. This finding is discussed, with emphasis on its implications for design of trials and clinical treatment of obese persons with type 2 diabetes.
Developments in biotechnology and genomics are providing a biological basis for the heterogeneity of clinical course and response to treatment that have long been apparent to clinicians. The ability to molecularly characterize human diseases presents new opportunities to develop more effective treatments and new challenges for the design and analysis of clinical trials. In oncology, treatment of broad populations with regimens that benefit a minority of patients is less economically sustainable with expensive molecularly targeted therapeutics. The established molecular heterogeneity of human diseases requires the development of new paradigms for the design and analysis of randomized clinical trials as a reliable basis for predictive medicine. We review prospective designs for the development of new therapeutics and predictive biomarkers to inform their use. We cover designs for a wide range of settings. At one extreme is the development of a new drug with a single candidate biomarker and strong biological evidence that marker negative patients are unlikely to benefit from the new drug. At the other extreme are Phase III clinical trials involving both genome-wide discovery of a predictive classifier and internal validation of that classifier. We have outlined a prediction-based approach to the analysis of randomized clinical trials that both preserves the Type I error and provides a reliable internally validated basis for predicting which patients are most likely or unlikely to benefit from the new regimen.
Murphy, Sean C.; Shott, Joseph P.; Parikh, Sunil; Etter, Paige; Prescott, William R.; Stewart, V. Ann
Malaria diagnostics are widely used in epidemiologic studies to investigate natural history of disease and in drug and vaccine clinical trials to exclude participants or evaluate efficacy. The Malaria Laboratory Network (MLN), managed by the Office of HIV/AIDS Network Coordination, is an international working group with mutual interests in malaria disease and diagnosis and in human immunodeficiency virus/acquired immunodeficiency syndrome clinical trials. The MLN considered and studied the wide array of available malaria diagnostic tests for their suitability for screening trial participants and/or obtaining study endpoints for malaria clinical trials, including studies of HIV/malaria co-infection and other malaria natural history studies. The MLN provides recommendations on microscopy, rapid diagnostic tests, serologic tests, and molecular assays to guide selection of the most appropriate test(s) for specific research objectives. In addition, this report provides recommendations regarding quality management to ensure reproducibility across sites in clinical trials. Performance evaluation, quality control, and external quality assessment are critical processes that must be implemented in all clinical trials using malaria tests. PMID:24062484
Heneweer, Carola; Grimm, Jan
Molecular imaging is aimed at the noninvasive in vivo characterization and measurement of processes at a cellular and molecular level with clinical imaging methods. Contrast agents are constructed to target markers that are specific either for certain diseases or for functional states of specialized tissues. Efforts are currently focused mainly on processes involved in angiogenesis, inflammation, and apoptosis. Cell tracking is performed for diagnostic purposes as well as for monitoring of novel cell therapies. Visualization of these processes would provide more precise information about disease expansion as well as treatment response, and could lead to a more individualized therapy for patients. Many attempts have shown promising results in preclinical studies; however, translation into the clinic remains a challenge. This applies especially to paediatrics because of more stringent safety concerns and the low prevalence of individual diseases. The most promising modalities for clinical translation are nuclear medicine methods (positron emission tomography [PET] and single photon emission CT [SPECT]) due to their high sensitivity, which allows concentrations below biological activity. However, special dose consideration is required for any application of ionizing radiation especially in children. While very little has been published on molecular imaging in a paediatric patient population beyond fluorodeoxyglucose (FDG)-PET and metaiodobenzylguanidine (MIBG) tracers, this review will attempt to discuss approaches that we believe have promise for paediatric imaging. These will include agents that already reached clinical trials as well as preclinical developments with high potential for clinical application.
Rosenkrantz, Andrew B; Mendiratta-Lala, Mishal; Bartholmai, Brian J.; Ganeshan, Dhakshinamoorthy; Abramson, Richard G.; Burton, Kirsteen R.; Yu, John-Paul J.; Scalzetti, Ernest M.; Yankeelov, Thomas E.; Subramaniam, Rathan M.; Lenchik, Leon
Quantitative imaging (QI) is increasingly applied in modern radiology practice, assisting in the clinical assessment of many patients and providing a source of biomarkers for a spectrum of diseases. QI is commonly used to inform patient diagnosis or prognosis, determine the choice of therapy, or monitor therapy response. Because most radiologists will likely implement some QI tools to meet the patient care needs of their referring clinicians, it is important for all radiologists to become familiar with the strengths and limitations of QI. The Association of University Radiologists Radiology Research Alliance Quantitative Imaging Task Force has explored the clinical application of QI and summarizes its work in this review. We provide an overview of the clinical use of QI by discussing QI tools that are currently employed in clinical practice, clinical applications of these tools, approaches to reporting of QI, and challenges to implementing QI. It is hoped that these insights will help radiologists recognize the tangible benefits of QI to their patients, their referring clinicians, and their own radiology practice. PMID:25442800
Lee, J. Jack; Chu, Caleb T.
Although the frequentist paradigm has been the predominant approach to clinical trial design since the 1940s, it has several notable limitations. The alternative Bayesian paradigm has been greatly enhanced by advancements in computational algorithms and computer hardware. Compared to its frequentist counterpart, the Bayesian framework has several unique advantages, and its incorporation into clinical trial design is occurring more frequently. Using an extensive literature review to assess how Bayesian methods are used in clinical trials, we find them most commonly used for dose finding, efficacy monitoring, toxicity monitoring, diagnosis/decision making, and for studying pharmacokinetics/pharmacodynamics. The additional infrastructure required for implementing Bayesian methods in clinical trials may include specialized software programs to run the study design, simulation, and analysis, and Web-based applications, which are particularly useful for timely data entry and analysis. Trial success requires not only the development of proper tools but also timely and accurate execution of data entry, quality control, adaptive randomization, and Bayesian computation. The relative merit of the Bayesian and frequentist approaches continues to be the subject of debate in statistics. However, more evidence can be found showing the convergence of the two camps, at least at the practical level. Ultimately, better clinical trial methods lead to more efficient designs, lower sample sizes, more accurate conclusions, and better outcomes for patients enrolled in the trials. Bayesian methods offer attractive alternatives for better trials. More such trials should be designed and conducted to refine the approach and demonstrate its real benefit in action. PMID:22711340
Lee, J Jack; Chu, Caleb T
Although the frequentist paradigm has been the predominant approach to clinical trial design since the 1940s, it has several notable limitations. Advancements in computational algorithms and computer hardware have greatly enhanced the alternative Bayesian paradigm. Compared with its frequentist counterpart, the Bayesian framework has several unique advantages, and its incorporation into clinical trial design is occurring more frequently. Using an extensive literature review to assess how Bayesian methods are used in clinical trials, we find them most commonly used for dose finding, efficacy monitoring, toxicity monitoring, diagnosis/decision making, and studying pharmacokinetics/pharmacodynamics. The additional infrastructure required for implementing Bayesian methods in clinical trials may include specialized software programs to run the study design, simulation and analysis, and web-based applications, all of which are particularly useful for timely data entry and analysis. Trial success requires not only the development of proper tools but also timely and accurate execution of data entry, quality control, adaptive randomization, and Bayesian computation. The relative merit of the Bayesian and frequentist approaches continues to be the subject of debate in statistics. However, more evidence can be found showing the convergence of the two camps, at least at the practical level. Ultimately, better clinical trial methods lead to more efficient designs, lower sample sizes, more accurate conclusions, and better outcomes for patients enrolled in the trials. Bayesian methods offer attractive alternatives for better trials. More Bayesian trials should be designed and conducted to refine the approach and demonstrate their real benefit in action.
Clinical Epidemiology Unit (CEU) conducts etiologic research with potential clinical and public health applications, and leads studies evaluating population-based early detection and cancer prevention strategies
Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard
Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.
Funke, G; von Graevenitz, A; Clarridge, J E; Bernard, K A
Coryneform bacteria are aerobically growing, asporogenous, non-partially-acid-fast, gram-positive rods of irregular morphology. Within the last few years, there has been a massive increase in the number of publications related to all aspects of their clinical microbiology. Clinical microbiologists are often confronted with making identifications within this heterogeneous group as well as with considerations of the clinical significance of such isolates. This review provides comprehensive information on the identification of coryneform bacteria and outlines recent changes in taxonomy. The following genera are covered: Corynebacterium, Turicella, Arthrobacter, Brevibacterium, Dermabacter. Propionibacterium, Rothia, Exiguobacterium, Oerskovia, Cellulomonas, Sanguibacter, Microbacterium, Aureobacterium, "Corynebacterium aquaticum," Arcanobacterium, and Actinomyces. Case reports claiming disease associations of coryneform bacteria are critically reviewed. Minimal microbiological requirements for publications on disease associations of coryneform bacteria are proposed. PMID:8993861
Gjorgov, A N
There are two major approaches to medical investigations: observational studies and experimental trials. The classical application of the experimental design to studies of human populations is the randomized clinical trial of the efficacy of a new drug or treatment. A further application of the experimental studies is to the testing of hypotheses about the etiology of a disease, already tested and corroborated from various forms of observational studies. Ethical considerations and requirements for consent of the experimental subjects are of primary concern in the clinical trials, and those concerns set the first and final limits for implementing a trial. General moral principles in research with human and animal beings, defined by the "Nuremberg Code," deal with strict criteria for approval, endorsement and evaluation of a clinical trial.
Miller, Joseph M
The study of infant vision is closely coupled to the study of the refraction, change in refraction over time, and the effect of spectacle correction on visual development. Frequently, reports are limited to descriptions of spherical equivalent or cylinder power without regard to axis, as data are frequently collected in the clinical format of sphere, cylinder, and axis (S, C, A). Conversion from clinical notation to a power vector representation of refraction allows unambiguous description of how refractions change over time and differ between repeated measurements. This article presents a series of examples of Microsoft Excel spreadsheet formulas that make the conversion from clinical notation to power vector format, and provides examples of useful applications of these methods.
Chick, P; Nixon, J
Data were obtained from 1,810 consecutive women who attended a central metropolitan (Brisbane) Family Planning Clinic during a 5 week period in 1982. Young women in particular formed the major client group with 32% being under 20 years of age. The client population was skewed towards women of upper socioeconomic status (SES). There was no SES disproportion in the use of oral contraceptives or IUD's. However, diaphragm use occurred disproportionately in women of upper SES groups; postcoital contraception was sought by and limited to, women of SES classes A and B only. The clinic satisfied a need for women with a history of failed or absent contraception and 15% had already had a termination of pregnancy by the time they first presented at the clinic.
Pashkovskiĭ, V E
To distinguish clinical variants and to specify nosologic entity of witchcraft delusions, 69 patients (10 males, aged 15-72 years) have been examined. It was found that witchcraft delusions exist in passive and active forms. In a passive form, the patient is sure that unknown (mystic) power damaged him/her; in an active form the patient, possessing a gift for unusual abilities, can influence the others (bewitches, heals, etc). Five clinical syndromes, in the structure of which the above delusions were found, namely, paranoiac-hypochondriac, hallucination-paranoid, depressive-paranoid, paraphrenic and delirious, were identified. Psychoses of schizophrenia spectrum were diagnosed in 52 patients, organic--in 8, alcoholic--in 7 and recurrent depressive disorder--in 2. Clinical significance of witchcraft delusions is closely related to its social aspect. Being combined with ideas of persecution, poisoning and damage, it results in the brutal forms of delusions defense and may be considered as an unfavorable prognostic trait.
Fortún, Jesús; Meije, Yolanda; Fresco, Gema; Moreno, Santiago
Invasive aspergillosis, chronic pulmonary aspergillosis and allergic bronchopulmonary aspergillosis are the clinical forms of aspergillosis. Although there is a great number of Aspergillus species, Aspergillus fumigatus-complex is the more frequent aetiological agent, regardless of clinical form or baseline condition. The increase in immunosuppressive agents and the higher use of corticosteroids in chronic obstructive pulmonary disease have led to aspergillosis becoming more prominent in recent years. Galactomannan detection and radiological diagnostic images complement the limitations of microbiology cultures in these patients. Voriconazole and liposomal amphotericin B are the gold standard in patients requiring therapy, and posaconazole, itraconazole, caspofungin and other echinocandins are effective alternatives. The prognosis depends of clinical forms and characteristics of the host, but it is particularly poor in the disseminated invasive forms.
Mould, R F
The design of clinical trials in cancer is a subject which features reasonably often among FRCR (Part 1) examination questions, and as such should be of more than passing interest to oncologists. It is also a subject which is gaining in relevance since the number of trials is increasing annually due in part to the many chemotherapeutic regimes which are being proposed. This paper which is based on a lecture given in Cambridge at the Hospital Physicists' Association Annual Conference in September 1978, is intended to act as an introduction to clinical trial design. References for further reading are given and, in particular, the extensive report on randomised clinical trials to the Medical Research Council's Leukaemia Steering Committee (Peto et al., 1977, 1978) is recommended.
Wright, J; Smith, M L; Jackson, D R
This paper describes the early development of clinical governance in an acute NHS Trust. Three Trust-wide workshops and 17 individual departmental workshops were held between 1998-1999. The discussions in these workshops were used to define the key founding principles of clinical governance and the operational structure. The philosophy behind clinical governance, to improve quality of services, was recognised as being part of mainstream trust business, not an optional add-on. The authors found that teamwork and multidisciplinary collaboration are essential components of future quality improvement. Effective leadership skills need to be supported and developed, with responsibilities shared between a core group within each department rather than one individual. Contributions should be recognised and rewarded. Collaboration with primary care and involvement of patients are prerequisites. Specific objectives should be agreed by each department and used to monitor progress. More effective use of existing resources (staff, time, IT and training) can be made.
Vargas, Angélica; Chiapas-Gasca, Karla; Hernández-Díaz, Cristina; Canoso, Juan J; Saavedra, Miguel Ángel; Navarro-Zarza, José Eduardo; Villaseñor-Ovies, Pablo; Kalish, Robert A
This article reviews the underlying anatomy of trigger finger and thumb (fibrous digital pulleys, sesamoid bones), flexor tenosynovitis, de Quervain's syndrome, Dupuytren's contracture, some hand deformities in rheumatoid arthritis, the carpal tunnel syndrome and the ulnar nerve compression at Guyon's canal. Some important syndromes and structures have not been included but such are the nature of these seminars. Rather than being complete, we aim at creating a system in which clinical cases are used to highlight the pertinent anatomy and, in the most important part of the seminar, these pertinent items are demonstrated by cross examination of participants and teachers. Self learning is critical for generating interest and expanding knowledge of clinical anatomy. Just look at your own hand in various positions, move it, feel it, feel also your forearms while you move the fingers, do this repeatedly and inquisitively and after a few tries you will have developed not only a taste, but also a lifelong interest in clinical anatomy.
The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines. PMID:26668751
Asher, Gary N; Spelman, Kevin
Turmeric root has been used medicinally in China and India for thousands of years. The active components are thought to be the curcuminoids, primarily curcumin, which is commonly available worldwide as a standardized extract. This article reviews the pharmacology of curcuminoids, their use and efficacy, potential adverse effects, and dosage and standardization. Preclinical studies point to mechanisms of action that are predominantly anti-inflammatory and antineoplastic, while early human clinical trials suggest beneficial effects for dyspepsia, peptic ulcer, inflammatory bowel disease, rheumatoid arthritis, osteoarthritis, uveitis, orbital pseudotumor, and pancreatic cancer. Curcumin is well-tolerated; the most common side effects are nausea and diarrhea. Theoretical interactions exist due to purported effects on metabolic enzymes and transport proteins, but clinical reports do not support any meaningful interactions. Nonetheless, caution, especially with chemotherapy agents, is advised. Late-phase clinical trials are still needed to confirm most beneficial effects.
Halldorsdottir (1990) investigated students’ perspective of a caring student- teacher encounter. Students described a caring teacher as being professionally...Nursing. Gaut, D. (1986). Evaluating caring nursing competencies in nursing practice. Topics in Clinical Nursing. 8(2), 77-83. Halldorsdottir , S. (1990
Chiozza, Maria Laura; Plebani, Mario
Reducing medical errors has become an international concern. Population-based studies from a number of nations around the world have consistently demonstrated unacceptably high rates of medical injury and preventable deaths. The introduction of effective reporting systems is a cornerstone of safe practice within hospitals and other healthcare organisations. Reporting can help to identify hazards and risks. However, reporting in itself does not improve safety. It is the response to reports that leads to change. Clinical teams must feel empowered to change the way in which they deliver their services, promoting effective clinical risk management. Process analysis, implementation of evidence-based practices, and a clear accountability system are effective tools not only for decreasing error rates, but also for improving effectiveness. Clinical Governance represents the context in which effective clinical risk management should be promoted and continuously improved. It should not be regarded as a separate activity, but should form part of the everyday practice of all healthcare professionals. It requires good multidisciplinary working and a willingness to reflect on and learn from errors to achieve a patient-centred and safer system.
In a climate of a cash-strapped medical system in the UK, there is acknowledgement that the need to provide safe, clinically effective, cost-efficient and patient-friendly medical care has never been more apparent. Recent legal cases in infertility and other specialties have made it clear that the trust of the public in healthcare providers is low. The response of the profession to this crisis of confidence needs to be swift and effective. The concept of standards setting is not new outside medical care. Regulatory structures now exist within medicine, and infertility investigation and treatment is now high on the agenda for careful scrutiny. The professions involved in reproductive medicine services urgently need to engage with government regulatory authorities as the agenda for the development of clinical standards and the potential for accreditation of clinics gathers momentum. This article examines the current status of clinical standards setting in the UK and recommends that in future the professional societies together with the Royal College of Obstetricians and Gynaecologists play a major role, in both the public and private sector, in advising existing assessors of quality.
Vila, Jordi; Gómez, María Dolores; Salavert, Miguel; Bosch, Jordi
The diagnostic methods of infectious diseases should be fast, accurate, simple and affordable. The speed of diagnosis can play a crucial role in healing the patient, allowing the administration of appropriate antibiotic treatment. One aspect that increasingly determines the need for rapid diagnostic techniques is the increased rates of serious infections caused by multidrug resistant bacteria, which cause a high probability of error in the empirical treatment. Some of the conventional methods such as Gram staining or antigen detection can generate results in less than 1 hour but lack sensitivity. Today we are witnessing a major change in clinical microbiology laboratories with the technological advances such as molecular diagnostics, digital microbiology and mass spectrometry. There are several studies showing that these changes in the microbiological diagnosis reduce the generation time of the test results, which has an obvious clinical impact. However, if we look into the future, other new technologies which will cover the needs required for a rapid microbiological diagnosis are on the horizon. This review provides an in depth analysis of the clinical impact that the implementation of rapid diagnostic techniques will have on unmet clinical needs.
Purpose: In this article, the author comments on aspects of Kamhi's (2014) article, which caused the author to think more deeply about definitions of language, theories of learning, and how these two core components of intervention prepare clinical scientists as they search the literature for new knowledge. Interprofessional collaborative…
Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven
To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding
Wang, You; Xu, Hui; Zhang, Jianming; Li, Guang
Demanded by modern medical diagnosis, advances in microfabrication technology have led to the development of fast, sensitive and selective electrochemical sensors for clinic analysis. This review addresses the principles behind electrochemical sensor design and fabrication, and introduces recent progress in the application of electrochemical sensors to analysis of clinical chemicals such as blood gases, electrolytes, metabolites, DNA and antibodies, including basic and applied research. Miniaturized commercial electrochemical biosensors will form the basis of inexpensive and easy to use devices for acquiring chemical information to bring sophisticated analytical capabilities to the non-specialist and general public alike in the future. PMID:27879810
Greiffenstein, Manfred F
Clinical myths and lore are unfounded beliefs that still influence practice decisions. I examine the validity of six beliefs commonly encountered in forensic neuropsychology practice: the admissibility of test batteries; avoidance of practice effects; forewarning insures good effort; average deficits in bright persons; 15% chronic impairment in mild brain injury; and examiner bias causing malingering. I show these beliefs are invalid because of material misunderstandings of case law and literature, falsification by empirical findings, and lack of authoritative sources. The benefits, costs, and persistence of clinical myths are discussed.
Remick, Ronald A.; Froese, Colleen
Monoamine oxidase inhibitors (MAOIs) are effective antidepressant agents. They are increasingly and effectively used in a number of other psychiatric and non-psychiatric medical syndromes. Their potential for serious toxicity (i.e., hypertensive reaction) is far less than original reports suggest, and newer reversible substrate-specific MAOIs may offer even less toxicity. The author reviews the pharmacology, mechanism of action, clinical indications, and dosing strategies of MAOIs. The common MAOI side-effects (hypotension, weight gain, sexual dysfunction, insomnia, daytime sedation, myoclonus, and hypertensive episodes) are described and management techniques suggested. Recent clinical developments involving MAOIs are outlined. PMID:21233984
Hampson, Geeta; Fogelman, Ignac
Bisphosphonates (BPs) are synthetic analogues of pyrophosphate. They inhibit bone resorption and are therefore widely used in disorders where there are increases or disruptions in bone resorption. This includes postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, Paget’s disease of bone, and malignancy-related bone loss. To best understand the clinical application of BPs, an understanding of their pharmacokinetics and pharmacodynamics is important. This review describes the structure, pharmacology and mode of action of BPs, focusing on their role in clinical practice. Controversies and side effects surrounding their use will also be discussed. PMID:23071416
Asheervath, J.; Blevins, D.R.
Written in outline format, this reference will help nurses further their understanding of advanced nursing procedures. Information is provided on the physiological, psychological, environmental, and safety considerations of nursing activities associated with diagnostic and therapeutic procedures. Special consideration is given to the areas of pediatric nursing, nursing assessment, and selected radiologic and nuclear medicine procedures for each system. Contents: Clinical Introduction. Clinical Nursing Practice: Focus on Basics. Focus on Cardiovascular Function. Focus on Respiratory Function. Focus on Gastrointestinal Function. Focus on Renal and Genito-Urological Function. Focus on Neuro-Skeletal and Muscular Function. Appendices.
DeFinney, John; Clements, David; Staines, Marilyn; Mior, Silvano
Mechanical pain in the region of the groin poses an interesting and at times confusing clinical dilemma. This is especially true for osteitis pubis, an inflammatory condition affecting the symphysis pubis. Recently it has been recognized as a potential source of pain in athletes. In this report, we will review the typical presentation of osteitis pubis, including the clinical, examination and radiographic features of this condition. A proposed plan of management, based on previous work on avulsion injuries is presented. A case report has been included to illustrate the salient features. ImagesFigure 1Figure 2Figure 4
Moore, M H; Cantrell, S B; Trott, J A; David, D J
The combination of bicoronal craniosynostosis, broad thumbs and great toes, and partial variable soft tissue syndactyly of the hands and feet (i.e., Pfeiffer syndrome) classically followed a benign clinical course. A review of the clinical features of those Pfeiffer syndrome patients presenting to our unit confirm another subgroup in whom the craniofacial and associated manifestations are more extreme, with a significant risk of early demise. The early aggressive surgical management of craniostenosis, hydrocephalus, exorbitism, faciostenosis, and upper airway obstruction has provided the potential for prolonged useful survival in these cases.
Moreno, M; White, E D; Flores, M E; Riethmayer, J
This study examined radiography students' perceptions regarding mistreatment during the clinical portion of their education. Results suggest that a majority of students perceived mistreatment and that second-year students were 4 times more likely to perceive mistreatment than first-year students. Most students who perceived mistreatment indicated that the abuse was verbal and came primarily from staff technologists. Most perceived the mistreatment to be slightly important and slightly upsetting. However, approximately one third perceived the mistreatment to be very important and very upsetting. As part of the study, students were asked to suggest preventive measures that could help eradicate abusive behavior in the clinical setting.
Goldberg, David M
In this paper, I review the origins of Clinical Enzymology with special emphasis on the years between 1960 and 1980 when the greatest advances in the subject took place. These are described in relation to my own research interests and contributions, focusing upon subclinical hepatic damage caused by viral infection and by alcohol; myocardial infarction; detection of cervical carcinoma by vaginal fluid analysis; evaluation of pancreatic function; and the clinical implications of microsomal enzyme induction. Reasons are proposed for the failure of enzymology to attain the status of an autonomous medical specialty, in contrast to the success of similar fields of knowledge that grew up in the same era.
Vogiatzis, Ioannis; Marvisi, Maurizio; Coolen, Johan; Gasparini, Stefano; Antoniou, Katerina M.; Stallberg, Bjorn; Bjerg, Anders; Herth, Felix J.F.; Clini, Enrico
This article reviews a selection of presentations in the area of clinical problems that were presented at the 2014 European Respiratory Society International Congress in Munich, Germany. We review the most recent and relevant topics of interest in the area of clinical respiratory medicine, encompassing novel reports and studies that are of particular interest to healthcare professionals. Topics ranging from basic science to translation research are presented and discussed in the context of the most up-to-date literature. In particular, the reviewed topics deal with chronic obstructive pulmonary disease and asthma, idiopathic pulmonary fibrosis (pathogenesis and therapy), advances in functional chest imaging, interventional pulmonology, pulmonary rehabilitation, and chronic care. PMID:27730129
Ginsberg, Ann M; Ruhwald, Morten; Mearns, Helen; McShane, Helen
The 4th Global Forum on TB Vaccines, convened in Shanghai, China, from 21 - 24 April 2015, brought together a wide and diverse community involved in tuberculosis vaccine research and development to discuss the current status of, and future directions for this critical effort. This paper summarizes the sessions on TB Vaccines in Clinical Development, and Clinical Research: Data and Findings. Summaries of all sessions from the 4th Global Forum are compiled in a special supplement of Tuberculosis. [August 2016, Vol 99, Supp S1, S1-S30].
Bergmann, J F; Chassany, O
To improve medical knowledge by reading clinical trial reports it is necessary to check for the respect of the methodological rules, and to analyze and criticize the results. A control group and a randomisation are always necessary. Double blind assessment, sample size calculation, intention to treat analysis, a unique primary end point are also important. The conclusions of the trial are valid only for the population included and the clinical signification of the results, depending on the control treatment, has to be evaluated. Respect of the reading rules is necessary to assess the reliability of the conclusions, in order to promote evidence-based practice.
Rovelli, Francesca; Mercuri, Santo Raffaele; Naldi, Luigi
Seborrheic dermatitis is a chronic relapsing inflammatory skin condition characterized by scaling and poorly defined erythematous patches in areas rich in sebaceous glands. It is one of the most frequent skin disorders and may be socially embarrassing. Fungi of the genus Malassezia, lipid-dependent, ubiquitous skin residents, play a pathogenic role. Topical antifungal agents (e.g., ketoconazole) are the mainstay of treatment, and if used intermittently they can maintain remission. The vehicle itself may also play a relevant role. Improvements in diagnostic criteria, severity measures and outcome variables are needed to better design clinical trials and inform clinical practice.
Ghosh, Rhia; Tabrizi, Sarah J
Huntington's disease (HD) is a devastating inherited neurodegenerative condition characterized by progressive motor, cognitive, and psychiatric symptoms. Symptoms progress over 15-20 years, and there are currently no disease-modifying therapies. The causative genetic mutation is an expanded CAG repeat in the HTT gene encoding the Huntingtin protein, and is inherited in an autosomal dominant manner. In this chapter we discuss the genetics, clinical presentation, and management of this condition, as well as new data from large-scale clinical research studies on the natural history of HD.
Weinigel, Martin; Breunig, Hans Georg; Kellner-Höfer, Marcel; Bückle, Rainer; Darvin, Maxim; Lademann, Juergen; König, Karsten
We combined two-photon fluorescence and coherent anti-Stokes Raman scattering (CARS) imaging in a clinical hybrid multiphoton tomograph for in vivo imaging of human skin. The clinically approved TPEF/CARS system provides simultaneous imaging of endogenous fluorophores and non-fluorescent lipids. The Stokes laser for the two-beam configuration of CARS is based on spectral broadening of femtosecond laser pulses in a photonic crystal fiber (PCF). We report on the highly flexible medical TPEF/CARS tomograph MPTflex®-CARS with an articulated arm and first in vivo measurements on human skin.
Niesters, Hubert G M
The ability to detect nucleic acids has had and still has a major impact on diagnostics in clinical virology. Both quantitative and qualitative techniques, whether signal or target amplification based systems, are currently used routinely in most if not all virology laboratories. Technological improvements, from automated sample isolation to real time amplification technology, have given the ability to develop and introduce systems for most viruses of clinical interest, and to obtain clinical relevant information needed for optimal antiviral treatment options. Both polymerase chain reaction (PCR) and nucleic acid sequence-based amplification (NASBA) can currently be used together with real time detection to generate results in a short turn-around time and to determine whether variants relevant for antiviral resistance are present. These new technologies enable the introduction of an individual patient disease management concept. Within our clinical setting, we have introduced this e.g. for quantitative detection of Epstein-Barr Virus (EBV) in T-dell depleted allogeneic stem cell transplant patients. This enabled us to develop models for pre-emptive anti B-cell immunotherapy for EBV reactivation, thereby effectively reducing not the incidence of EBV-lymphoproliferative disease but the virus related mortality. Furthermore, additional clinically relevant viruses can now easily be detected simultaneously. It also becomes more feasible to introduce molecular testing for those viruses that can easily be detected using classical virological methods, like culture techniques or antigen detection. Prospective studies are needed to evaluate the clinical importance of the additional positive samples detected. It should however be made clear that a complete exchange of technologies is unlikely to occur, and that some complementary technologies should stay operational enabling the discovery of new viruses. The implementation of these molecular diagnostic technologies furthermore
Summers, Ron; Vyas, Hiten; Dudhal, Nilesh; Doherty, Neil F; Coombs, Crispin R; Hepworth, Mark
This paper will investigate innovations in information management for use in clinical trials. The application typifies a complex, adaptive, distributed and information-rich environment for which continuous innovation is necessary. Organisational innovation is highlighted as well as the technical innovations in workflow processes and their representation as an integrated set of web services. Benefits realization uncovers further innovations in the business strand of the work undertaken. Following the description of the development of this information management system, the semantic web is postulated as a possible solution to tame the complexity related to information management issues found within clinical trials support systems.
Ng, T; Marx, G; Littlewood, T; Macdougall, I
The introduction of recombinant human erythropoietin (RHuEPO) has revolutionised the treatment of patients with anaemia of chronic renal disease. Clinical studies have demonstrated that RHuEPO is also useful in various non-uraemic conditions including haematological and oncological disorders, prematurity, HIV infection, and perioperative therapies. Besides highlighting both the historical and functional aspects of RHuEPO, this review discusses the applications of RHuEPO in clinical practice and the potential problems of RHuEPO treatment. PMID:12897214
Strauss, David G.; Blinova, Ksenia
Clinical trials ‘in a dish’ involve testing medical therapies for safety or effectiveness in the laboratory with human tissue. This has become possible owing to recent biotechnology advances including induced pluripotent stem cells, organs-on-a-chip, and whole-genome sequencing. We provide here an overview of the landscape and highlight steps the FDA is taking to advance the science of clinical trials in a dish and to support the development and validation of new regulatory paradigms to assess drug safety using these new technologies. PMID:27876286
Endobronchial tuberculosis (EBTB) is defined as tuberculous infection of the tracheobronchial tree. The exact pathogenesis is unclear, and it has a heterogenous clinical course. Its diagnosis requires the clinician to have a high index of suspicion based on clinical symptoms and radiological features. Computed tomography and bronchoscopy are useful tools in its evaluation. The goal of treatment is in the eradication of tuberculous bacilli with appropriate anti-tuberculous therapy. Use of corticosteroids is controversial for the prevention of tracheobronchial stenosis. Interventional bronchoscopy or surgical intervention is employed to restore airway patency once significant stenosis occurs. PMID:28203440
Tinsley, D; O'Dwyer, J J; Benson, P E; Doyle, P T; Sandler, J
The aim of this paper is to familiarize the readers with some of the clinical considerations necessary to ensure successful use of mid-palatal implants. Both surgical and technical aspects will be discussed along with a description of impression techniques used.
Pillers, De-Ann M.; Schleiss, Mark R.
Gentamicin is an aminoglycoside antibiotic that has been a mainstay in pediatric care for decades. Although new antibiotics are constantly under development, gentamicin continues to play an important role in clinical medicine. Although this may be surprising in the context of evidence of an association with hearing loss, both on a toxicity and a…
Accardo, Pasquale J., Ed.; Magnusen, Christy, Ed.; Capute, Arnold J., Ed.
This text examines the characteristics that define autism: impairments in communication; abnormal social development; and clinically significant odd behaviors. Specific chapters include: (1) Neural Mechanisms in Autism (Andrew W. Zimmerman and Barry Gordon); (2) Epidemiology of Autism and Other Pervasive Developmental Disorders: Current…
This master's thesis presents several instructional methods and techniques developed for each of eleven topics or subject areas in clinical chemistry: carbohydrate metabolism, lipid metabolism, diagnostic enzymology, endocrinology, toxicology, quality control, electrolytes, acid base balance, hepatic function, nonprotein nitrogenous compounds, and…
Gher, M E; Dunlap, R M; Anderson, M H; Kuhl, L V
Through a standardized procedure using clinical examination, interviews, and dental history, this 2-year study documents 100 cases of tooth fracture in 98 patients. For comparison, pertinent information was also recorded for more than 2,000 teeth in a randomly selected sample population. Two chief types of fracture were found: incomplete crown-root fractures and root fractures associated with earlier endodontic therapy.
Schoolcraft, V; Delaney, C
The use of contracts in grading clinical performance has provided faculty with a solution to two important problems. One has been how to ensure that students are graded consistently among the various faculty who are grading the same clinical component of a course. The second has been to increase the opportunity for individualized attention to student learning needs. We have been pleased to see all the faculty members increase their input and involvement in the continuing modifications of the contract. Although we have taken the major responsibility for the semi-annual revisions of the contract, other faculty members have been increasingly more explicit in their evaluations and suggestions as their experience with the contract has expanded. Their confidence in this method of clinical evaluation has increased with each semester of use. We plan to continue in the refinement of the instrument and will develop materials for the use of other faculty groups who are interested in developing similar contracts. We are also designing a survey to attempt to discover how widespread is the use of contract grading in clinical areas.
In order to continue to do great work with challenging youth, teachers should know that learning helps them be better professionals. Clinical supervision is one of the vehicles used. In a Re-ED program, those who work directly with youth (called teacher-counselors) are the primary agents of change. This makes it necessary to equip them with the…
Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida
The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763
Justino, Celine I L; Duarte, Armando C; Rocha-Santos, Teresa A P
The application of simple, cost-effective, rapid, and accurate diagnostic technologies for detection and identification of cardiac and cancer biomarkers has been a central point in the clinical area. Biosensors have been recognized as efficient alternatives for the diagnostics of various diseases due to their specificity and potential for application on real samples. The role of nanotechnology in the construction of immunological biosensors, that is, immunosensors, has contributed to the improvement of sensitivity, since they are based in the affinity between antibody and antigen. Other analytes than biomarkers such as hormones, pathogenic bacteria, and virus have also been detected by immunosensors for clinical point-of-care applications. In this chapter, we first introduced the various types of immunosensors and discussed their applications in clinical diagnostics over the recent 6 years, mainly as point-of-care technologies for the determination of cardiac and cancer biomarkers, hormones, pathogenic bacteria, and virus. The future perspectives of these devices in the field of clinical diagnostics are also evaluated.
Clinical research implies advancing current knowledge about health care by continually developing and testing new ideas about diseases, products, procedures, and strategies. Although this trait is inherent in human nature, it needs to be encouraged, nurtured, groomed, and channelized by creating a suitable atmosphere for it, providing the necessary resources, inculcating the necessary conceptual and manual skills, and rewarding the efforts and achievements suitably. Language, logic, statistics, and psychology play an important role in acquiring and developing research capability. To be socially relevant and economically viable, clinical research will need to partner with patients and their doctors in identifying what their goals of health care are, what they value, and what they are willing to "buy" in terms of goods and services. Besides, clinical research will need to bring on one platform the sponsors, the researchers, the patients, the payers, and the regulators to ensure that they do not work at cross purposes, that the cost of developing health care measures is scaled down through innovative approaches such as large simple trials, sequential trials, early marketing conditional on post-marketing surveillance, and so on. All these will be possible if day-to-day practice is slowly and systemically transformed into the largest laboratory of clinical research, which it ought to be, by forming networks of research-oriented practices, and popularizing the use of data collection and analysis tools such as Epi Info which are in the public domain.
Westen, Drew; Weinberger, Joel
This paper presents replies to comments published by M. S. Schulz and R. J. Waldinger, J. M. Wood and M. T. Nezworski, and H. N. Garb and W. M. Grove on the original article by D. Westen and J. Weinberger. Schulz and Waldinger (2005) make the important point that just as researchers can capitalize on the knowledge of experienced clinical observers…
The NCI Community Oncology Research Program (NCORP) is a national network of investigators, cancer care providers, academic institutions, and other organizations. NCORP conducts multi-site cancer clinical trials and studies in diverse populations in community-based healthcare systems across the United States and Puerto Rico.
Low, Hsien Min; Chinchure, Dinesh
A 50-year-old Chinese man presented with abdominal pain associated with bloody mucoid stools, loss of appetite and weight loss. Contrast-enhanced computed tomography of the abdomen and pelvis revealed a colocolic intussusception secondary to a lipoma. The patient subsequently underwent a left hemicolectomy. Clinical and imaging findings of intussusception in adults are discussed in this article. PMID:27995264
Pick, Andrew; Berry, Shelley; Gilbert, Kayleigh; McCaul, James
Since increasing numbers of patients are asked to take part in clinical trials, nurses need to be aware of the principles of valid, informed consent. This article explores consent, which aims to protect the rights, safety and wellbeing of patients. In particular, the history of consent in research and the elements involved in obtaining informed consent from potential participants in research studies are discussed.
Slavkin, Harold C.
Discussion of the future of clinical dentistry looks at a variety of influences, including historical development factors; demographic trends; the role of the Human Genome Project in the development of scientific knowledge; a paradigm shift in approaches to oral infection and systemic disease; advancing technology; and reforms resulting from these…
Stinson, J M; Talley, P A; Thomas, F E
The fungus Histoplasma capsulatum produces a spectrum of disease forms ranging from a benign self-limited illness to progressive disseminated disease with a 50 percent mortality rate. The drug of choice, amphotericin B, must be given intravenously over a prolonged course and carries a high incidence of toxicity. Thus, optimal managment of serious forms of histoplasmosis requires considerable clinical judgment.
Recent data reveal that subtle selective publication affects critical aspects of trial reporting, in some cases altering the interpretation of results. Timely prospective registration could help deter selective reporting and clinical trial stakeholders from government authorities to journal editors should work together to foster prospective registration of trials.
Bate, Louise; Hutchinson, Andrew; Underhill, Jonathan; Maskrey, Neal
There is much variation in the implementation of the best available evidence into clinical practice. These gaps between evidence and practice are often a result of multiple individual decisions. When making a decision, there is so much potentially relevant information available, it is impossible to know or process it all (so called 'bounded rationality'). Usually, a limited amount of information is selected to reach a sufficiently satisfactory decision, a process known as satisficing. There are two key processes used in decision making: System 1 and System 2. System 1 involves fast, intuitive decisions; System 2 is a deliberate analytical approach, used to locate information which is not instantly recalled. Human beings unconsciously use System 1 processing whenever possible because it is quicker and requires less effort than System 2. In clinical practice, gaps between evidence and practice can occur when a clinician develops a pattern of knowledge, which is then relied on for decisions using System 1 processing, without the activation of a System 2 check against the best available evidence from high quality research. The processing of information and decision making may be influenced by a number of cognitive biases, of which the decision maker may be unaware. Interventions to encourage appropriate use of System 1 and System 2 processing have been shown to improve clinical decision making. Increased understanding of decision making processes and common sources of error should help clinical decision makers to minimize avoidable mistakes and increase the proportion of decisions that are better.
Fogelman, I. )
The topics covered in this book include the history of bone scanning, mechanisms of uptake of diphosphonate in bone, the normal bone scan, and the role of bone scanning in clinical practice. The aim of this book is to provide a source of reference relating to bone scan imaging for all those who are interested in the skeleton.
Ryan, Melody; Yang, Li; Nie, Xiao-Yan; Zhai, Suo-Di; Shi, Lu-Wen; Lubawy, William C.
Pharmacy education in China focuses on pharmaceutical sciences, with the bachelor of science (BS) of pharmacy as the entry-level degree. Pharmacy practice curricula in these programs are centered on compounding, dispensing, pharmacy administration, and laboratory experiences, which are the traditional responsibilities for pharmacists. Additional graduate-level training is available at the master of science (MS) and the doctor of philosophy (PhD) levels, most of which concentrate on drug discovery and drug development research. Presently, the emphasis in practice is beginning to shift to clinical pharmacy. With this change, additional degree offerings are being developed to meet the growing demand for clinical pharmacists. There is also interest in developing more clinical skills in practicing pharmacists through additional non-degree training. The Ministry of Education is considering a proposal for an entry-level professional degree of master and/or doctor in clinical pharmacy similar to the doctor of pharmacy (PharmD) degree in the United States. PMID:19325949
Regular communication between the clinical engineering department and the wider hospital community not only keeps other departments informed about CE activities, but also conveys the value that CE brings to the institution. We provide a list of topics and information that CE should consider conveying to various groups within the hospital.
This article presents an overview of advances in the clinical and neuropsychological assessment of malingering, issues in diagnostic differential, neuropsychological and psychodynamic test methods, and special issues presented by medical - legal context, and other factors which may affect presentations. Cautions and recommendations for practice are presented.
Paschke, Kelly M; Mashir, Alquam
Breath testing has the potential to benefit the medical field as a cost-effective, non-invasive diagnostic tool for diseases of the lung and beyond. With growing evidence of clinical worth, standardization of methods, and new sensor and detection technologies the stage is set for breath testing to gain considerable attention and wider application in upcoming years. PMID:21173863
Background Network Tools and Applications in Biology (NETTAB) Workshops are a series of meetings focused on the most promising and innovative ICT tools and to their usefulness in Bioinformatics. The NETTAB 2011 workshop, held in Pavia, Italy, in October 2011 was aimed at presenting some of the most relevant methods, tools and infrastructures that are nowadays available for Clinical Bioinformatics (CBI), the research field that deals with clinical applications of bioinformatics. Methods In this editorial, the viewpoints and opinions of three world CBI leaders, who have been invited to participate in a panel discussion of the NETTAB workshop on the next challenges and future opportunities of this field, are reported. These include the development of data warehouses and ICT infrastructures for data sharing, the definition of standards for sharing phenotypic data and the implementation of novel tools to implement efficient search computing solutions. Results Some of the most important design features of a CBI-ICT infrastructure are presented, including data warehousing, modularity and flexibility, open-source development, semantic interoperability, integrated search and retrieval of -omics information. Conclusions Clinical Bioinformatics goals are ambitious. Many factors, including the availability of high-throughput "-omics" technologies and equipment, the widespread availability of clinical data warehouses and the noteworthy increase in data storage and computational power of the most recent ICT systems, justify research and efforts in this domain, which promises to be a crucial leveraging factor for biomedical research. PMID:23095472
Yildiz, Bulent O
Hyperandrogenism or androgen excess is a common endocrine disorder of women of reproductive-age, with a prevalence of 5-10%. The majority of patients with hyperandrogenism will have polycystic ovary syndrome. Hyperandrogenism presents a complex diagnostic challenge for both the practicing physician and the clinical investigator. Clinical manifestations of hyperandrogenism include hirsutism, acne, androgenic alopecia, and virilization. Hirsutism, defined as excessive growth of terminal hair in women in a male-like pattern, is the most commonly used clinical diagnostic criterion of hyperandrogenism. The presence of hirsutism is usually determined by using a standardized scoring system of hair growth. Depending on the definition, hirsutism is present in up to 80% of patients with hyperandrogenism. Acne and androgenic alopecia are other common androgenic skin changes, and might be observed without hirsutism in some hyperandrogenic women. However, isolated presence of any of these manifestations is not used as a diagnostic criterion for hyperandrogenism. Virilization is a relatively uncommon feature of hyperandrogenism, and its presence often suggests an androgen-producing tumor. A thorough history and a focused clinical examination are extremely helpful in diagnostic evaluation of patients with suspected hyperandrogenism.
Ahmed, Nabeela; Poate, Tim; Nacher-Garcia, Cristina; Pugh, Nicola; Cowgill, Helen; Page, Lisa; Matthews, N Shaun
Patients with dysfunction of the temporomandibular joint (TMJ) commonly present to oral and maxillofacial departments and are increasingly being managed by a subspecialist group of surgeons. We review the outcomes of patients attending a specialist TMJ multidisciplinary team (MDT) clinic. All patients are simultaneously reviewed by a consultant oral and maxillofacial surgeon, consultant in oral medicine, specialist physiotherapist, and maxillofacial prosthetist, and they can also see a consultant liaison psychiatrist. They are referred from primary, secondary, and tertiary care when medical and surgical treatment in the routine TMJ clinic has failed, and are triaged by the attending maxillofacial surgeon. On discharge they are returned to the care of the referring practitioner. We review the outcomes of patients attending this clinic over a 2-year period and show improvements in pain scores and maximal incisal opening, as well as quality of life outcome measures. All units in the UK with an interest in the management of diseases of the TMJ should consider establishing this type of clinic and should use available resources and expertise to maximise outcomes.
Hearn, Cherie; Govier, Adam; Semciw, Adam Ivan
Objective Clinical care ratios (CCRs) are a useful tool that can be used to quantify and benchmark the clinical and non-clinical workloads of allied health professionals. The purpose of this study was to determine if CCRs are influenced by level of seniority, type of role or profession. This will provide meaningful information for allied health service managers to better manage service demand and capacity.Method Data was collected from 2036 allied health professionals from five professions across 11 Australian tertiary hospitals. Mean (95% confidence intervals) CCRs were calculated according to profession, seniority and role type. A two-way ANOVA was performed to assess the association of CCRs (dependent variable) with seniority level and profession (independent variables). Post-hoc pairwise comparisons identified where significant main or interaction effects occurred (α = 0.05).Results Significant main effects for seniority level and profession were identified (P < 0.05), but there was no interaction effect. Post-hoc comparisons revealed significant differences between all tier combinations (P < 0.05) with more senior staff having the lowest CCRs.Conclusion The direct and non-direct clinical components of the allied health professional's workload can be quantified and benchmarked with like roles and according to seniority. The benchmarked CCRs for predominantly clinical roles will enable managers to compare and evaluate like roles and modify non-direct clinical components according to seniority and discipline.What is known about the topic? CCRs are a useful tool to quantify, monitor and compare workloads of allied health professionals. They are thought to change with increased seniority of roles. The CCRs for different allied health professional roles has yet to be defined in the literature.What does this paper add? CCRs decrease as level of seniority increases, indicating higher seniority increases non-clinical time. CCRs differ across professions, suggesting
Bowen, Denise M
The purpose of Linking Research to Clinical Practice is to present evidence based information to clinical dental hygienists so that they can make informed decisions regarding patient treatment and recommendations. Each issue will feature a different topic area of importance to clinical dental hygienists with A BOTTOM LINE to translate the research findings into clinical application.
SKILLICORN, STANLEY A.
IN THE SUMMER OF 1965, A MIGRANT HEALTH CLINIC WAS STARTED IN THE SOUTHERN PART OF SANTA CLARA COUNTY, CALIFORNIA. THE CLINIC DIFFERS FROM THE PUBLIC HEALTH DEPARTMENT'S CLINICS BY OFFERING TREATMENT AND MEDICATION, INSTEAD OF ONLY PREVENTIVE SERVICES. THE ENTIRE STAFF, FROM DOCTORS TO BABY-SITTERS, VOLUNTEERS ITS TIME, AND THE CLINIC IS NOW OPEN…
Selected topics in the contemporary clinical medicine are reflected. The main fields of interest and characteristic features unifying theory and praxis are outlined; specificities of clinical thinking and decision making, and conception of clinical medicine as a scientific discipline are presented. Author deals with assurances, various forms of irresolution in clinical medicine and with problems resulting from the scientific progress.
Levy, Linda S.; Gardner, Greg; Barnum, Mary G.; Willeford, K. Sean; Sexton, Patrick; Guyer, M. Susan; Fincher, A. Louise
Introduction: The medical education model provides the basis for athletic training students to learn theoretical and practical skills. Clinical rotations are completed where they apply what they have learned under the direct supervision of a clinical instructor (CI) or approved clinical instructor (ACI). Approved clinical instructors are taught…
... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug... are cosponsoring a 3- day training course for clinical investigators on scientific, ethical, and regulatory aspects of clinical trials. This training course is intended to provide clinical...
Magner, Martin; Kolářová, Hana; Honzik, Tomáš; Švandová, Ivana; Zeman, Jiří
Mitochondrial disorders (MD) represent a clinically, biochemically and genetically heterogeneous group of diseases associated with dysfunction of the oxidative phosphorylation system and pyruvate dehydrogenase complex. Our aim was to illustrate the most common clinical presentation of MD on the example of selected diseases and syndromes. The minimal prevalence of MD is estimated as 1 to 5,000. MD may manifest at any age since birth until late-adulthood with acute manifestation or as a chronic progressive disease. Virtually any organ may be impaired, but the organs with the highest energetic demands are most frequently involved, including brain, muscle, heart and liver. Some MD may manifest as a characteristic cluster of clinical features (e.g. MELAS syndrome, Kearns-Sayre syndrome). Diagnostics includes detailed history, the comprehensive clinical examination, results of specialized examinations (especially cardiology, visual fundus examination, brain imaging, EMG), laboratory testing of body fluids (lactate, aminoacids, organic acids), and analysis of bioptic samples of muscle, skin, and liver, eventually. Normal lactate level in blood does not exclude the possibility of MD. Although the aimed molecular genetic analyses may be indicated in some of mitochondrial diseases, the methods of next generation sequencing come into focus. Examples of treatment are arginine supplementation in MELAS syndrome, ketogenic diet in pyruvate oxidation disorders or quinone analogs in patients with LHON. Conclusion: The clinical suspicion of a mitochondrial disorder is often delayed, or the disease remains undiagnosed. The correct diagnosis and adequate treatment can improve prognosis of the patient. Access to genetic counseling is also of great importance.
Monaco, A P
The morbidity and mortality associated with chronic immunosuppression provide a strong motivation for development of clinical tolerance. This paper discusses the definition(s) of clinical (operational) tolerance, the role of chimerism in experimental and clinical tolerance, and the special role of bone marrow in tolerance induction. The states of microchimerism and macrochimerism are defined and related to certain clinical observations in solid organ transplantation. Current clinical strategies already being tested in the clinic are briefly reviewed. Certain principles for induction of clinical (operational) tolerance are elaborated.
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...
... (CONTINUED) MEDICAL DEVICES CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES Clinical Laboratory... clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury,...
König, Karsten; Bückle, Rainer; Weinigel, Martin; Elsner, Peter; Kaatz, Martin
We report on applications of high-resolution clinical multiphoton tomography based on the femtosecond laser system DermaInspectTM with its flexible mirror arm in Australia, Asia, and Europe. Applications include early detection of melanoma, in situ tracing of pharmacological and cosmetical compounds including ZnO nanoparticles in the epidermis and upper dermis, the determination of the skin aging index SAAID as well as the study of the effects of anti-aging products. In addition, first clinical studies with novel rigid high-NA two-photon 1.6 mm GRIN microendoscopes have been conducted to study the effect of wound healing in chronic wounds (ulcus ulcera) as well as to perform intrabody imaging with subcellular resolution in small animals.
Ganesan, Kavita; Lloyd, Shane; Sarkar, Vikren
The ability to find highly related clinical concepts is essential for many applications such as for hypothesis generation, query expansion for medical literature search, search results filtering, ICD-10 code filtering and many other applications. While manually constructed medical terminologies such as SNOMED CT can surface certain related concepts, these terminologies are inadequate as they depend on expertise of several subject matter experts making the terminology curation process open to geographic and language bias. In addition, these terminologies also provide no quantifiable evidence on how related the concepts are. In this work, we explore an unsupervised graphical approach to mine related concepts by leveraging the volume within large amounts of clinical notes. Our evaluation shows that we are able to use a data driven approach to discovering highly related concepts for various search terms including medications, symptoms and diseases. PMID:27656096
Morales La Madrid, Andres; Hashizume, Rintaro; Kieran, Mark W.
In spite of major recent advances in diffuse intrinsic pontine glioma (DIPG) molecular characterization, this body of knowledge has not yet translated into better treatments. To date, more than 250 clinical trials evaluating radiotherapy along with conventional cytotoxic chemotherapy as well as newer biologic agents have failed to improve the dismal outcome when compared to palliative radiation alone. The biology of DIPG remained unknown until recently when the neurosurgical expertise along with the recognition by the scientific and clinical community of the importance of tissue sampling at diagnosis; ideally, in the context of a clinical trial and by trained neurosurgical teams to maximize patient safety. These pre-treatment tumor samples, and others coming from tissue obtained post-mortem, have yielded new insights into DIPG molecular pathogenesis. We now know that DIPG comprises a heterogeneous disease with variable molecular phenotypes, different from adult high-grade glioma, other non-pontine pediatric high-grade gliomas, and even between pontine gliomas. The discovery of histone H3.3 or H3.1 mutations has been an important step forward in understanding tumor formation, maintenance, and progression. Pharmacologic reversal of DIPG histone demethylation therefore offers an important potential intervention strategy for the treatment of DIPG. To date, clinical trials of newly diagnosed or progressive DIPG with epigenetic (histone) modifiers have been unsuccessful. Whether this failure represents limited activity of the agents used, their CNS penetration, redundant pathways within the tumor, or the possibility that histone mutations are necessary only to initiate DIPGs but not maintain their growth, suggest that a great deal still needs to be elucidated in both the underlying biology of these pathways and the drugs designed to target them. In this review, we will discuss the role of both epigenetic and genetic mutations within DIPG and the development of treatment
A clinical study must address true endpoints that matter for the patients and the doctors. A good clinical study starts with a good clinical question. Formulating a clinical question in the form of PECO can sharpen one's original question. In order to perform a good clinical study one must have a knowledge of study design, measurements and statistical analyses: The first is taught by epidemiology, the second by psychometrics and the third by biostatistics.
Brown, Aaron P.; Citrin, Deborah E.; Camphausen, Kevin A.
Introduction An expanding understanding of the importance of angiogenesis in oncology and the development of numerous angiogenesis inhibitors are driving the search for biomarkers of angiogenesis. We review currently available candidate biomarkers and surrogate markers of anti-angiogenic agent effect. Discussion A number of invasive, minimally invasive, and non-invasive tools are described with their potential benefits and limitations. Diverse markers can evaluate tumor tissue or biological fluids, or specialized imaging modalities. Conclusions The inclusion of these markers into clinical trials may provide insight into appropriate dosing for desired biological effects, appropriate timing of additional therapy, prediction of individual response to an agent, insight into the interaction of chemotherapy and radiation following exposure to these agents, and perhaps most importantly, a better understanding of the complex nature of angiogenesis in human tumors. While many markers have potential for clinical use, it is not yet clear which marker or combination of markers will prove most useful. PMID:18414993
Literary reports on dystonia date back to post-Medieval times. Medical reports are instead more recent. We review here the early descriptions and the historical establishment of a consensus on the clinical phenomenology and the diagnostic features of dystonia syndromes. Lumping and splitting exercises have characterized this area of knowledge, and it remains largely unclear how many dystonia types we are to count. This review describes the history leading to recognize that focal dystonia syndromes are a coherent clinical set encompassing cranial dystonia (including blepharospasm), oromandibular dystonia, spasmodic torticollis, truncal dystonia, writer’s cramp, and other occupational dystonias. Papers describing features of dystonia and diagnostic criteria are critically analyzed and put into historical perspective. Issues and inconsistencies in this lumping effort are discussed, and the currently unmet needs are critically reviewed. PMID:28217105
Liu, Hui; Chang, Joe Y.
Radiation dose escalation and acceleration improves local control but also increases toxicity. Proton radiation is an emerging therapy for localized cancers that is being sought with increasing frequency by patients. Compared with photon therapy, proton therapy spares more critical structures due to its unique physics. The physical properties of a proton beam make it ideal for clinical applications. By modulating the Bragg peak of protons in energy and time, a conformal radiation dose with or without intensity modulation can be delivered to the target while sparing the surrounding normal tissues. Thus, proton therapy is ideal when organ preservation is a priority. However, protons are more sensitive to organ motion and anatomy changes compared with photons. In this article, we review practical issues of proton therapy, describe its image-guided treatment planning and delivery, discuss clinical outcome for cancer patients, and suggest challenges and the future development of proton therapy. PMID:21527064
Borrell-Carrió, F; Hernández-Clemente, J C
The purpose of this article is to analyze some models of expert decision and their impact on the clinical practice. We have analyzed decision-making considering the cognitive aspects (explanatory models, perceptual skills, analysis of the variability of a phenomenon, creating habits and inertia of reasoning and declarative models based on criteria). We have added the importance of emotions in decision making within highly complex situations, such as those occurring within the clinical practice. The quality of the reflective act depends, among other factors, on the ability of metacognition (thinking about what we think). Finally, we propose an educational strategy based on having a task supervisor and rectification scenarios to improve the quality of medical decision making.
Vale, Artur; Guerra, Miguel; Martins, Daniel; Lameiras, Angelina; Miranda, José; Vouga, Luís
Nocardia genus microorganisms are ubiquitous, Gram positive aerobic bacterias, responsible for disease mainly in immunocompromised hosts, with cellular immune response commitment. Inhalation is the main form of transmition and pulmonary disease is the most frequent presentation. Dissemination may occur by contiguity and also via hematogenous. The clinical and imaging presentation is not specific, and diagnosis is obtained after identification of Nocardia bacteria in biological samples. Since there are no reliable studies that indicate the best therapeutic option, treatment should be individualized and based on antimicrobial susceptibility testing. Surgical drainage should also be considered in all patients. The authors present a clinical case of a patient with thoracic nocardiosis, and make a short literature review on the theme.
Wasfy, Meagan M; Baggish, Aaron L
There is wide variability in the physical activity patterns of the patients in contemporary clinical cardiovascular practice. This review is designed to address the impact of exercise dose on key cardiovascular risk factors and on mortality. We begin by examining the body of literature that supports a dose-response relationship between exercise and cardiovascular disease risk factors, including plasma lipids, hypertension, diabetes mellitus, and obesity. We next explore the relationship between exercise dose and mortality by reviewing the relevant epidemiological literature underlying current physical activity guideline recommendations. We then expand this discussion to critically examine recent data pertaining to the impact of exercise dose at the lowest and highest ends of the spectrum. Finally, we provide a framework for how the key concepts of exercise dose can be integrated into clinical practice.
Lai, Yusheng Keefe; Mahmood, Rameysh Danovani
A 16-year-old Chinese male patient presented with constipation lasting five days, colicky abdominal pain, lethargy, weakness and body aches. He was able to pass flatus. Abdominal radiography showed a distended stomach causing inferior displacement of the transverse colon. Computed tomography revealed a dilated oesophagus, stomach and duodenum up to its third portion, with a short aortomesenteric distance and narrow angle. There was also consolidation in the lungs bilaterally. Based on the constellation of clinical and imaging findings, a diagnosis of superior mesenteric artery syndrome complicated by aspiration pneumonia was made. The patient was subsequently started on intravenous hydration, nasogastric tube aspiration and antibiotics. Following stabilisation of his acute condition, a nasojejunal feeding tube was inserted and a feeding plan was implemented to promote weight gain. The clinical presentation, differentials, diagnosis and treatment of superior mesenteric artery syndrome are discussed. PMID:27212130
Over the past decades, randomised controlled trials (RCTs) have prevailed over clinical judgement, case reports, and observational studies and became the gold evidential standard in medicine. Furthermore, during the same time frame, RCTs became a crucial part of the regulatory process whereby a new therapeutic can gain access to the drug market. Today, clinical trials are large and tightly regulated enterprises that have to comply with ethical requirements while maintaining high epistemic standards, a balance that becomes increasingly difficult as the research questions become more sophisticated. In this review, the author will discuss some of the most important ethical issues surrounding RCTs, with an eye to the most recent debates and the context of oncological research in particular. PMID:24482672
An important factor contributing to the process involved in choosing a rehabilitation intervention is the assessment of its impact on the real life of patients. Therapists and physicians have to infer the effectiveness of rehabilitation approaches from observations performed in the clinical setting and from patients' feedback. Recent advances in wearable technology have provided means to supplement the information gathered using tools based on patient's direct observation as well as interviews and questionnaires. A new generation of wearable sensors and systems has recently become available thus providing clinical personnel with a "window of observation" in the home and community settings. These tools allow one to capture patients' activity level and exercise compliance, facilitate titration of medications in chronic patients, and provide means to assess the ability of patients to perform specific motor activities. In this paper, we review recent advances in the field of wearable technology and provide examples of application of this technology in rehabilitation.
Scott, L; Grimmer, K
Clinical indicators offer physiotherapists a tool by which quality of care can be flagged and evaluated. Such a flag requires a measure of the cost of treatment as well as the outcome achieved for that cost. Traditionally, the number of treatments to discharge has been used as a proxy measure of cost as well as outcome of physiotherapy care. However, physiotherapists recognize that the cost of treatment is an inappropriate reflection of the outcome of care in many instances. The challenge for physiotherapists in developing clinical indicators is to set appropriate flags of quality of care. This paper presents a methodological approach to the development of a flag of performance for acute lower back pain.
Sartoris, D J
The purpose of this article is to provide insight into the long-standing controversy over the clinical value of noninvasive measurement of bone mass. Results of recent studies have increasingly supported the judicious use of bone densitometry as a clinical tool . These reports contradict editorials on the limitations of bone densitometry that have appeared in a variety of subspecialty publications [2,3]. The importance of bone mass measurement is underscored by the lack of success in predicting bone density from various combinations of anthropometric and historical variables. Growing evidence suggests that densitometry is a useful tool for determining which women near menopause are at risk for osteoporosis and, therefore, are candidates for estrogen-replacement therapy. This article summarizes current concepts on the subject and attempts to prove that bone densitometry is a beneficial and indicated procedure for selected patients.
Mainstream psychotherapy has made huge strides in treating symptoms and disorders, but it has largely overlooked happiness as a therapeutic goal despite frequently hearing from clients, "Doctor, I want to be happy." This issue of Journal of Clinical Psychology: In Session describes a number of positive interventions for specific clinical problems, such as depression, anxiety, schizophrenia, loss, grief, and relationship distress. Although the name may suggest it, positive interventions do not imply that rest of psychotherapies are negative. Neither are negatives denied nor minimized. Distinct from self-help recipes proffering instant changes, positive psychology interventions refer to systematic approaches to overcome challenges by using clients' strengths and assets. A hybrid psychotherapy-coaching model and strength-based assessment can ask a client "What is right with you?" All articles are supplemented with rich case illustrations.
Despotović, Nebojsa; Zdravković, Mihajlo
Multiple arterial disease is presented by coexistence of ischaemic heart disease, carotid disease and peripheral obliterate arterial disease. Atherosclerosis is the main factor for onset of the disease. Among 150 patients with clinical manifestations of obliterate disease of at least two aforementioned arterial systems, we examined by many noninvasive and invasive procedures the existence and degree of obliterate arterial disease of coronary, carotid and peripheral arteries of the lower extremities. The results revealed the statistically significant correlation among: ischaemic heart disease and carotid disease (r = 0.939; p < 0.01); ischaemic heart disease and peripheral arterial disease (r = 0.834; p < 0.05); ischaemic heart disease, peripheral arterial disease and carotid disease (r = 0.986; p < 0.01). The results pointed out that whenever clinical manifestations of obliterate disease of peripheral arteries are present, there is also need for routine examination of existent coronary artery disease.
Botulinum toxin, the most potent biological toxin, has become a powerful therapeutic tool for a growing number of clinical applications. This review draws attention to new findings about the mechanism of action of botulinum toxin and briefly reviews some of its most frequent uses, focusing on evidence based data. Double blind, placebo controlled studies, as well as open label clinical trials, provide evidence that, when appropriate targets and doses are selected, botulinum toxin temporarily ameliorates disorders associated with excessive muscle contraction or autonomic dysfunction. When injected not more often than every three months, the risk of blocking antibodies is slight. Long term experience with this agent suggests that it is an effective and safe treatment not only for approved indications but also for an increasing number of off-label indications. PMID:15201348
Frankel, F H
The essential aspect in the experience of the hypnotized person is the altered or distorted perception that is suggested to him. Not all people are capable of the experience, but it is possible that spontaneous distortions occur in those with high hypnotizability. These distortions are frequently experienced as frightening symptoms. The author draws attention to the similarity between hysterical symptoms and events in hypnosis and to the high hypnotic responsivity in hysterical subjects reported in the clinical literature of the nineteenth century. Phobic patients have relatively high hypnotic responsivity. The author believes that it is sometimes possible to predict hypnotizability from clinical behavior, and that hypnotic responsivity can be utilized in psychodynamically sensitive therapy to teach such patients that they can learn to gain control of their symptoms.
New technologies for mutation detection in the human genome have greatly increased our understanding of epilepsy genetics. Application of genomic technologies in the clinical setting allows for more efficient genetic diagnosis in some patients; therefore, it is important to understand the types of tests available and the types of mutations that can be detected. Making a genetic diagnosis improves overall patient care by enhancing prognosis and recurrence risk counseling and informing treatment decisions. PMID:26316867
Lingeman, James E.
Extracorporeal shock wave lithotripsy (ESWL) has revolutionized the treatment of urolithiasis. Because of the clinical success of the original lithotriptor, the Dornier HM3, numerous manufacturers introduced different approaches to lithotripsy based on empiricism rather than an understanding of the fundamental mechanisms of this new technology. Our understanding of shock wave physics and the physiologic effects of shock waves has progressed greatly over the last decade resulting in insights that hopefully will be reflected favorably in future lithotriptor designs and lithotripsy techniques.
Conflict is common in healthcare settings and can affect the functioning of a dialysis clinic. Unresolved conflict can decrease staff productivity and teamwork, and potentially decrease the quality of patient care. This article discusses the causes and effects of conflict, describes the five basic conflict-handling styles that can be useful when dealing with conflict (avoidance, accommodation, competing, compromise, and collaboration), and provides resources for resolving patient-provider conflict.
Sanderson, Iain C; Obeid, Jihad S; Madathil, Kapil Chalil; Gerken, Katherine; Fryar, Katrina; Rugg, Daniel; Alstad, Colin E; Alexander, Randall; Brady, Kathleen T; Gramopadhye, Anand K; Moskowitz, Jay
Background One mechanism to increase participation in research is to solicit potential research participants’ general willingness to be recruited into clinical trials. Such research permissions and consents typically are collected on paper upon patient registration. We describe a novel method of capturing this information electronically. Purpose The objective is to enable the collection of research permissions and informed consent data electronically to permit tracking of potential research participants’ interest in current and future research involvement and to provide a foundation for facilitating the research workflow. Methods The project involved systematic analysis focused on key areas, including existing business practices, registration processes, and permission collection workflows, and ascertaining best practices for presenting consent information to users via tablet technology and capturing permissions data. Analysis was followed by an iterative software development cycle with feedback from subject matter experts and users. Results An initial version of the software was piloted at one institution in South Carolina for a period of 1 year, during which consents and permission were collected during 2524 registrations of patients. The captured research permission data were transmitted to a clinical data warehouse. The software was later released as an open-source package that can be adopted for use by other institutions. Limitations There are significant ethical, legal, and informatics challenges that must be addressed at an institution to deploy such a system. We have not yet assessed the long-term impact of the system on recruitment of patients to clinical trials. Conclusions We propose that by improving the ability to track willing potential research participants, we can improve recruitment into clinical trials and, in the process, improve patient education by introducing multimedia to informed consent documents. PMID:23785065
these have shown significant promise in simplifying the interpretation of confocal microscopy images. ii. Raman fibers for clinical applications...If a laser interacts with tissue, there is a specific back scattered Raman signal. It has been discovered that fibrous plaque (good) in the...coronary artery has a different Raman signal from fatty plaque (bad). This may be a predictor for stroke or heart attack. In order to make this
A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient.
Kuhar, Peggy A; Lewicki, Linda J; Modic, Mary Beth; Schaab, Debbie; Rump, Colleen; Bixler, Sarah
The awarding of Magnet Status by the Magnet Nursing Services Recognition Program of the American Nursing Credentialing Center is acknowledged as the achievement of Excellence in Nursing. In this article, The Cleveland Clinic shares insights from its experience in becoming the 72nd Magnet hospital. Questions to ponder when conducting a readiness assessment before embarking on the Magnet journey, techniques to engage the staff in the application process, and writing and organizing tips are shared.
Badesch, D B
Progress in treatment of pulmonary hypertension has been impaired by the lack of formal clinical trials. This is now beginning to change, and the impact on our approach to treating patients with pulmonary hypertension in substantial. As with other relatively uncommon medical disorders, randomized, controlled, multi-center trials are needed to assess the safety and efficacy of potential therapeutic modalities. Treatments showing promise at the level of small pilot studies within a single center should be studied more rigorously.
The purpose of this research is to enlight the actual nursing act of the student in order to search for what makes sense in his (her) self nursing becoming and to reinterpret what is said regarding what is done. Up till, researchs were focused on declarative intentions; instead here, we go beyond using an innovative approach based on the clinical activity research method applied to the nursing education field.
Phan, Kelvin; McCarty, Cailee W.; Mutchler, Jessica M.; Van Lunen, Bonnie
Context: Clinical education is the interaction between a clinical preceptor and student within the clinical setting to help the student progress as a clinician. Post-professional athletic training clinical education is especially important to improve these students' clinical knowledge and skills. However, little research has been conducted to…
Dodge, Thomas M.; Mazerolle, Stephanie M.; Bowman, Thomas G.
Context: Clinical integration impacts athletic training students' (ATSs) motivation and persistence. Research has yet to elucidate the manner in which different clinical placements can influence clinical integration. Objective: To examine differences in the levels of clinical integration achieved by ATSs across various clinical sport assignments.…
Bakheit, A; Fedorova, N; Skoromets, A; Timerbaeva, S; Bhakta, B; Coxon, L
Objective: To study the efficacy, safety, and incidence of BtxA antibody formation with repeated treatments with BtxA in post-stroke upper limb muscle spasticity. Methods: The study was a prospective open label trial. Patients with established post-stroke upper limb spasticity received 1000 units of BtxA (Dysport) into five muscles of the affected arm on study entry. Treatment was repeated every 12, 16, or 20 weeks as clinically indicated. Each patient received a total of three treatment cycles. Efficacy of treatment was assessed using the Modified Ashworth Scale. Patients were assessed on study entry and on week 4 and 12 of each treatment cycle for all safety and efficacy parameters. Blood samples for BtxA antibody assay were taken at baseline and on completion of the trial. Results: Fifty one patients were recruited and 41 of them completed the study. Improvement from the cycle one baseline was observed in all the outcome measures. Mild to moderately severe treatment related adverse events were reported in 24% of cases. There were no serious adverse events. No BtxA antibodies were detected. Conclusion: BtxA at a dose of 1000 units Dysport was efficacious in the symptomatic treatment of post-stroke upper limb spasticity. The study suggests that this effect can be maintained with repeated injections for up to at least three treatment cycles, with duration of effect per cycle of between 12 and 20 weeks. BtxA was safe in the dose used in this study and did not induce the formation of detectable levels of neutralising BtxA antibodies. PMID:15489387
Czarnywojtek, Agata; Bączyk, Maciej; Ziemnicka, Katarzyna; Fischbach, Jakub; Wrotkowska, Elżbieta; Ruchała, Marek
Gastroenteropancreatic (GEP) endocrine tumours (carcinoids and pancreatic islet cell tumours) are composed of multipotent neuroendocrine cells that exhibit a unique ability to produce, store, and secrete biologically active substances and cause distinct clinical syndromes. The classification of GEP tumours as functioning or non-functioning is based on the presence of symptoms that accompany these syndromes secondary to the secretion of hormones, neuropeptides and/or neurotransmitters (functioning tumours). Non-functioning tumours are considered to be neoplasms of neuroendocrine differentiation that are not associated with obvious symptoms attributed to the hypersecretion of metabolically active substances. However, a number of these tumours are either capable of producing low levels of such substances, which can be detected by immunohistochemistry but are insufficient to cause symptoms related to a clinical syndrome, or alternatively, they may secrete substances that are either metabolically inactive or inappropriately processed. In some cases, GEP tumours are not associated with the production of any hormone or neurotransmitter. Both functioning and non-functioning tumours can also produce symptoms due to mass effects compressing vital surrounding structures. Gastroenteropancreatic tumours are usually classified further according to the anatomic site of origin: foregut (including respiratory tract, thymus, stomach, duodenum, and pancreas), midgut (including small intestine, appendix, and right colon), and hindgut (including transverse colon, sigmoid, and rectum). Within these subgroups the biological and clinical characteristics of the tumours vary considerably, but this classification is still in use because a significant number of previous studies, mainly observational, have used it extensively. PMID:26516377
Banerjee, Sangeeta Ray; Pomper, Martin G
Gallium-68 is a positron-emitting radioisotope that is produced from a (68)Ge/(68)Ga generator. As such it is conveniently used, decoupling radiopharmacies from the need for a cyclotron on site. Gallium-68-labeled peptides have been recognized as a new class of radiopharmaceuticals showing fast target localization and blood clearance. (68)Ga-DOTATOC, (8)Ga-DOTATATE, (68)Ga-DOTANOC, are the most prominent radiopharmaceuticals currently in use for imaging and differentiating lesions of various somatostatin receptor subtypes, overexpressed in many neuroendocrine tumors. There has been a tremendous increase in the number of clinical studies with (68)Ga over the past few years around the world, including within the United States. An estimated ∼10,000 scans are being performed yearly in Europe at about 100 centers utilizing (68)Ga-labeled somatostatin analogs within clinical trials. Two academic sites within the US have also begun to undertake human studies. This review will focus on the clinical experience of selected, well-established and recently applied (68)Ga-labeled imaging agents used in nuclear medicine.
Fitzgerald, Rebecca C; Caldas, Carlos
The clinical management of familial gastric cancer is the same as that for sporadic gastric cancer at the current time. As the causative mutations for these cases are identified this should lead to the development of specific treatments which target the molecular abnormality. The only germline mutations identified so far occur within the E-cadherin gene (CDHI) and they account for approximately 30% of familial gastric cancer cases. When index patients fulfilling the clinical criteria for hereditary diffuse gastric cancer syndrome have a CDHI mutation identified then genetic testing of asymptomatic relatives should be considered. The clinical sequelae of testing positive for such a mutation are profound and therefore it is essential that counselling is given prior to genetic testing. The management options are surveillance endoscopy and prophylactic gastrectomy. In this chapter the practicalities of genetic testing are discussed as well as the pros and cons of the two management options. It is essential that experience of these rare families is pooled so that surveillance and treatment can be optimised in the future.
Cianfoni, Alessandro; Pravatà, Emanuele; De Blasi, Roberto; Tschuor, Costa Silvia; Bonaldi, Giuseppe
Presentation of a cerebral aneurysm can be incidental, discovered at imaging obtained for unrelated causes, can occur in the occasion of imaging obtained for symptoms possibly or likely related to the presence of an unruptured aneurysm, or can occur with signs and symptoms at the time of aneurismal rupture. Most unruptured intracranial aneurysms are thought to be asymptomatic, or present with vague or non-specific symptoms like headache or dizziness. Isolated oculomotor nerve palsies, however, may typically indicate the presence of a posterior circulation aneurysm. Ruptured intracranial aneurysms are by far the most common cause of non-traumatic subarachnoid hemorrhage and represent a neurological emergency with potentially devastating consequences. Subarachnoid hemorrhage may be easily suspected in the presence of sudden and severe headache, vomiting, meningism signs, and/or altered mental status. However, failure to recognize milder and more ambiguous clinical pictures may result in a delayed or missed diagnosis. In this paper we will describe the clinical spectrum of unruptured and ruptured intracranial aneurysms by discussing both typical and uncommon clinical features emerging from the literature review. We will additionally provide the reader with descriptions of the underlying pathophysiologic mechanisms, and main diagnostic pitfalls.
Cook, M J
The purpose of this work was to explore clinical nursing leadership. The research was based on a critical examination of the leadership themes derived from the nursing literature of the United Kingdom, the United States of America and Australia, between 1992 and 1997. The work was also influenced by the findings from semistructured interviews undertaken with five clinical leaders in nursing from the United Kingdom, and study tours to both the United States of America and Australia. The findings support a proposed leadership model as a basis for further exploration and as a framework for contemplating clinical leadership and leadership preparation. A model is presented that identifies factors which influence leadership styles, such as external environment, internal environment, experience and understanding. Four leadership styles are outlined: transactional, transformational, connective and renaissance. These leadership styles are linked to nursing care approaches. A second model provides a basis for considering power and its impact in the workplace. Based on these findings, the contents of a leadership preparation course are outlined.
NARAYAN, RAJ K.; MICHEL, MARY ELLEN; Ansell, Beth; Baethmann, Alex; Biegon, Anat; Bracken, Michael B.; Bullock, M. Ross; Choi, Sung C.; Clifton, Guy L.; Contant, Charles F.; Coplin, William M.; Dietrich, W. Dalton; Ghajar, Jamshid; Grady, Sean M.; Grossman, Robert G.; Hall, Edward D.; Heetderks, William; Hovda, David A.; Jallo, Jack; Katz, Russell L.; Knoller, Nachshon; Kochanek, Patrick M.; Maas, Andrew I.; Majde, Jeannine; Marion, Donald W.; Marmarou, Anthony; Marshall, Lawrence F.; McIntosh, Tracy K.; Miller, Emmy; Mohberg, Noel; Muizelaar, J. Paul; Pitts, Lawrence H.; Quinn, Peter; Riesenfeld, Gad; Robertson, Claudia S.; Strauss, Kenneth I.; Teasdale, Graham; Temkin, Nancy; Tuma, Ronald; Wade, Charles; Walker, Michael D.; Weinrich, Michael; Whyte, John; Wilberger, Jack; Young, A. Byron; Yurkewicz, Lorraine
Traumatic brain injury (TBI) remains a major public health problem globally. In the United States the incidence of closed head injuries admitted to hospitals is conservatively estimated to be 200 per 100,000 population, and the incidence of penetrating head injury is estimated to be 12 per 100,000, the highest of any developed country in the world. This yields an approximate number of 500,000 new cases each year, a sizeable proportion of which demonstrate signficant long-term disabilities. Unfortunately, there is a paucity of proven therapies for this disease. For a variety of reasons, clinical trials for this condition have been difficult to design and perform. Despite promising pre-clinical data, most of the trials that have been performed in recent years have failed to demonstrate any significant improvement in outcomes. The reasons for these failures have not always been apparent and any insights gained were not always shared. It was therefore feared that we were running the risk of repeating our mistakes. Recognizing the importance of TBI, the National Institute of Neurological Disorders and Stroke (NINDS) sponsored a workshop that brought together experts from clinical, research, and pharmaceutical backgrounds. This workshop proved to be very informative and yielded many insights into previous and future TBI trials. This paper is an attempt to summarize the key points made at the workshop. It is hoped that these lessons will enhance the planning and design of future efforts in this important field of research. PMID:12042091
Ferner, R E
Clinical pharmacology assumes that deductions can be made about the concentrations of drugs from a knowledge of the pharmacokinetic parameters in an individual; and that the effects are related to the measured concentration. Post-mortem changes render the assumptions of clinical pharmacology largely invalid, and make the interpretation of concentrations measured in post-mortem samples difficult or impossible. Qualitative tests can show the presence of substances that were not present in life, and can fail to detect substances that led to death. Quantitative analysis is subject to error in itself, and because post-mortem concentrations vary in largely unpredictable ways with the site and time of sampling, as a result of the phenomenon of post-mortem redistribution. Consequently, compilations of ‘lethal concentrations’ are misleading. There is a lack of adequate studies of the true relationship between fatal events and the concentrations that can be measured subsequently, but without such studies, clinical pharmacologists and others should be wary of interpreting post-mortem measurements. PMID:18637886
Didangelos, Triantafyllos; Doupis, John; Veves, Aristidis
Painful diabetic neuropathy (PDN) is one of several clinical syndromes in patients with diabetic peripheral neuropathy (DPN) and presents a major challenge for optimal management. The epidemiology of PDN has not been extensively studied. On the basis of available data, the prevalence of pain ranges from 10% to 20% in patients with diabetes and from 40% to 50% in those with diabetic neuropathy. Neuropathic pain can be disabling and devastating, with a significant impact on the patient's quality of life and associated healthcare cost. Pathophysiologic mechanisms underlying PDN are similar to other neuropathic pain disorders and broadly invoke peripheral and central sensitization. The natural course of PDN is variable, with the majority of patients experiencing spontaneous improvement and resolution of pain. Quantifying neuropathic pain is difficult, especially in clinical practice, but has improved recently in clinical trials with the development of neuropathic pain-specific tools, such as the Neuropathic Pain Questionnaire and the Neuropathic Pain Symptom Inventory. Hyperglycemia-induced pathways result in nerve dysfunction and damage, which lead to hyperexcitable peripheral and central pathways of pain. Glycemic control may prevent or partially reverse DPN and modulate PDN.
Alexandrov, Andrei V.
Phase II CLOTBUST randomized clinical trial (Houston, Barcelona, Edmonton, Calgary) evaluated patients with acute ischemic stroke due to intracranial occlusion and treated with intravenous tissue plasminogen activator (TPA) within 3 h of symptom onset. Randomization: monitoring with pulsed wave 2 MHz transcranial Doppler (TCD) (Target) or placebo monitoring (Control). Safety: symptomatic bleeding to the brain (sICH). Primary end-point: complete recanalization on TCD or dramatic clinical recovery by the total NIHSS score <3, or improvement by >10 NIHSS points within 2 hours after TPA bolus. All projected 126 patients were randomized 1:1 to target (median NIHSS 16) or control (NIHSS 17). sICH: 4.8% Target, 4.8% Controls. Primary end-point was achieved by 31 (49%, Target) versus 19 (30%, Control), p<0.03. At 3 months, 22 (42% Target) and 14 (29% Control) patients achieved favorable outcomes. Continuous TCD monitoring of intracranial occlusion safely augments TPA-induced arterial recanalization, and 2 MHz diagnostic ultrasound has a positive biological activity that aids systemic thrombolytic therapy. For the first time in clinical medicine, the CLOTBUST trial provides the evidence that ultrasound enhances thrombolytic activity of a drug in humans thereby confirming intense multi-disciplinary experimental research conducted worldwide for the past 30 years.
de Graaff, L C G; van Schaik, R H N; van Gelder, T
Taking into account the high frequency of adverse drug reactions (ADRs) in the clinic and taking into account the growing knowledge of the genetic mechanisms underlying some of these ADRs, we believe that every clinician should know at least the basic principles of pharmacogenetics. However, our experience is that many clinicians are unaware of the potential contribution of pharmacogenetic testing and have not implemented this new modality in their daily practice. We present a case of Stevens-Johnson syndrome in a patient treated with carbamazepine. Following the pathways of clinical reasoning, we describe the possibilities of pharmacogenetic testing in the clinic (HLA-B*1502 and HLA-A*3101 in our patient). We describe the pharmacological and pharmacogenetic aspects relevant for the clinician's daily practice (the existence of ADR subtypes, cytochrome P450, drug-drug interactions, genetic variations, CYP450 and HLA genotyping). Based on the Dutch top 100 of most prescribed drugs, we provide data on CYP450 and HLA genotypes relevant to those 100 most commonly used drugs. We discuss the availability and costs of pharmacogenetic testing, show a calculation of the 'number needed to genotype' and, based on these data, we propose a decision model for pharmacogenetic testing by clinicians.
Greber, Katarzyna E; Dawgul, Małgorzata
Today microbial drug resistance has become a serious problem not only within inpatient setting but also within outpatient setting. Repeated intake and unnecessary usage of antibiotics as well as the transfer of resistance genes are the most important factors that make the microorganisms resistant to conventional antibiotics. A large number of antimicrobials successfully used for prophylaxis and therapeutic purposes have now become ineffective [1, 2]. Therefore, new molecules are being studied to be used in the treatment of various diseases. Some of these molecules are structural compounds based on a combination of peptides, for example, naturally occurring endogenous peptide antibiotics and their synthetic analogues or molecules designed de novo using QSAR (quantitative structureproperty relationships)-based methods . Trying to exploit numerous advantages of antimicrobial peptides such as high potency and selectivity, broad range of targets, potentially low toxicity and low accumulation in tissues, pharmaceutical industry aims to develop them as commercially available drugs and appropriate clinical trials are being conducted . In this paper we define clinical trials steps and describe current status of several antimicrobial peptides under clinical development as well as briefly depict peptide drug formulation.
In his influential 1987 essay, "Equipoise and The Ethics of Randomized Clinical Research," Benjamin Freedman argued that Charles Fried's theoretical equipoise requirement threatened clinical research because it was overwhelmingly fragile and rendered unethical too many randomized clinical trials. Freedman, therefore, proposed an alternative requirement, the clinical equipoise requirement, which is now considered to be the fundamental or guiding principle concerning the ethics of enrolling patients in randomized clinical trials. In this essay I argue that Freedman's clinical equipoise requirement is ambiguous and can be interpreted in (at least) two different ways. I furthermore claim that, ironically, the best interpretation of the clinical equipoise requirement opens Freedman to the same objection that he leveled against Fried twenty-five years ago; namely, that it (Freedman's clinical equipoise requirement) renders unethical too many randomized clinical trials.
Dogra, Sunil; Mahajan, Rahul
On the basis of current evidence derived from hospital-based studies, mostly from North India, the prevalence of psoriasis in adults varies from 0.44 to 2.8%, with a much lower prevalence in children. The peak age at onset in adults is in the third and fourth decade of life, with a slight male preponderance. It is recommended that population-based large epidemiologic studies should be undertaken in different parts of the country for estimating the correct prevalence of psoriasis in general population. Chronic plaque-type psoriasis is the most common morphologic presentation of psoriasis, accounting for more than 90% of all cases. Other morphologic variants that deserve special mention include palmoplantar psoriasis, pustular psoriasis, and recalcitrant psoriasis. For epidemiologic purposes, psoriasis can be classified into early and late onset psoriasis. Psoriasis can be classified on the basis of morphology and extent of involvement into localized and widespread disease. For the purpose of clinical trials, psoriasis may be classified as mild psoriasis, moderate psoriasis, and severe psoriasis. The literature shows that there is a significant risk of psoriatic arthritis (7–48%) in patients with plaque-type psoriasis. Hence, it is recommended to evaluate for its presence by detailed history taking and clinical examination, and if necessary, by appropriate radiological investigations. Evidence on the association between plaque-type psoriasis and cardiovascular disease risk factors and ischemic heart disease isinconsistent. On the basis ofavailable evidence, it is prudent to proactively look for metabolic syndrome, dyslipidemia, and obesity, especially in patientswith severe psoriasis (Level 1+ evidence based on systematic reviews and meta-analysis). Based on the current evidence, the psoriasis area severity index appears to be the most valid and reproducible clinical severity score in the management of adult patients with plaque-type psoriasis. PMID:27990381
... drugs, devices, and biologics; as well as inspections of clinical investigators, IRBs, and research... HUMAN SERVICES Food and Drug Administration Food and Drug Administration Clinical Trial Requirements, Compliance, and Good Clinical Practice; Public Workshop AGENCY: Food and Drug Administration, HHS....
Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual
This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102
Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual
This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.
Talavera, Juan O; Rivas-Ruiz, Rodolfo
Two strategies to understand and document causality are: 1) clinical reasoning (CR) and 2) clinical trial (CT). CR identifies: basal state, maneuver and outcome. These components show us the complex of causality, its identification and control allows us to avoid systematic errors, such as: at baseline-improper assembly and susceptibility bias, during the application of the maneuver-performance bias, and at measurement of outcome-detection and transfer bias. In the CT tactics attempt to separate the effect of the main maneuver from the effect of other components that participate in causality previously described in CR. CT takes advantage of its characteristics: the opportunity to manipulate the maneuver and the temporality into the causal relationship. Some features to highlight are: the allocation of the maneuver, blinding of the maneuver, the feasibility of early interruption of the maneuver, the analysis according to maneuver adherence, the groups to compare, the timing of comparative maneuver, and the informed consent. Each occasion the clinician applies all this knowledge and skills, in a conscious way and structured, he improves his efficiency and align medical practice with clinical research.
Choi, In Young; Kim, Tae-Min; Kim, Myung Shin; Mun, Seong K; Chung, Yeun-Jun
The advances in electronic medical records (EMRs) and bioinformatics (BI) represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO) aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population.
Choi, In Young; Kim, Tae-Min; Kim, Myung Shin; Mun, Seong K.
The advances in electronic medical records (EMRs) and bioinformatics (BI) represent two significant trends in healthcare. The widespread adoption of EMR systems and the completion of the Human Genome Project developed the technologies for data acquisition, analysis, and visualization in two different domains. The massive amount of data from both clinical and biology domains is expected to provide personalized, preventive, and predictive healthcare services in the near future. The integrated use of EMR and BI data needs to consider four key informatics areas: data modeling, analytics, standardization, and privacy. Bioclinical data warehouses integrating heterogeneous patient-related clinical or omics data should be considered. The representative standardization effort by the Clinical Bioinformatics Ontology (CBO) aims to provide uniquely identified concepts to include molecular pathology terminologies. Since individual genome data are easily used to predict current and future health status, different safeguards to ensure confidentiality should be considered. In this paper, we focused on the informatics aspects of integrating the EMR community and BI community by identifying opportunities, challenges, and approaches to provide the best possible care service for our patients and the population. PMID:24465229
Changes in the health care system, brought on by cost control measures, are expected to have an impact on clinical education opportunities in allied health. There has been speculation that clinical facilities, upon which academic programs depend for clinical education, will begin charging fees for allowing students to rotate through their facilities. A survey was conducted of 43 schools and colleges of allied health, comprising 274 programs in 46 different disciplines to ascertain the extent to which programs were paying for clinical education. Two basic research questions were addressed: (1) to what extent are academic institutions supporting direct costs for clinical education of students and (2) to what extent are academic institutions exchanging resources with clinical facilities in which their students are receiving clinical education? Data were collected on cash payments made to clinical facilities, payment of preceptors, academic faculty in direct supervision of students in the clinics, tuition credit bank for clinical supervisors, university provision of inservice training for the clinical faculty, and university provision of equipment for use by students in the clinical facility. Results indicate that very few programs are making cash payments--2.2% in academic health centers and 10.6% in non-academic health centers (four-year colleges). In lieu of cash payments, a number of resource exchanges take place between educational institutions and clinical facilities.
Eppstein, Margaret J; Horbar, Jeffrey D; Buzas, Jeffrey S; Kauffman, Stuart A
Widespread unexplained variations in clinical practices and patient outcomes suggest major opportunities for improving the quality and safety of medical care. However, there is little consensus regarding how to best identify and disseminate healthcare improvements and a dearth of theory to guide the debate. Many consider multicenter randomized controlled trials to be the gold standard of evidence-based medicine, although results are often inconclusive or may not be generally applicable due to differences in the contexts within which care is provided. Increasingly, others advocate the use "quality improvement collaboratives", in which multi-institutional teams share information to identify potentially better practices that are subsequently evaluated in the local contexts of specific institutions, but there is concern that such collaborative learning approaches lack the statistical rigor of randomized trials. Using an agent-based model, we show how and why a collaborative learning approach almost invariably leads to greater improvements in expected patient outcomes than more traditional approaches in searching simulated clinical fitness landscapes. This is due to a combination of greater statistical power and more context-dependent evaluation of treatments, especially in complex terrains where some combinations of practices may interact in affecting outcomes. The results of our simulations are consistent with observed limitations of randomized controlled trials and provide important insights into probable reasons for effectiveness of quality improvement collaboratives in the complex socio-technical environments of healthcare institutions. Our approach illustrates how modeling the evolution of medical practice as search on a clinical fitness landscape can aid in identifying and understanding strategies for improving the quality and safety of medical care.
Camilleri, Michael; Parkman, Henry P.; Shafi, Mehnaz A.; Abell, Thomas L.; Gerson, Lauren
This guideline presents recommendations for the evaluation and management of patients with gastroparesis. Gastroparesis is identified in clinical practice through the recognition of the clinical symptoms and documentation of delayed gastric emptying. Symptoms from gastroparesis include nausea, vomiting, early satiety, postprandial fullness, bloating, and upper abdominal pain. Management of gastroparesis should include assessment and correction of nutritional state, relief of symptoms, improvement of gastric emptying and, in diabetics, glycemic control. Patient nutritional state should be managed by oral dietary modifications. If oral intake is not adequate, then enteral nutrition via jejunostomy tube needs to be considered. Parenteral nutrition is rarely required when hydration and nutritional state cannot be maintained. Medical treatment entails use of prokinetic and antiemetic therapies. Current approved treatment options, including metoclopramide and gastric electrical stimulation (GES, approved on a humanitarian device exemption), do not adequately address clinical need. Antiemetics have not been specifically tested in gastroparesis, but they may relieve nausea and vomiting. Other medications aimed at symptom relief include unapproved medications or off-label indications, and include domperidone, erythromycin (primarily over a short term), and centrally acting antidepressants used as symptom modulators. GES may relieve symptoms, including weekly vomiting frequency, and the need for nutritional supplementation, based on open-label studies. Second-line approaches include venting gastrostomy or feeding jejunostomy; intrapyloric botulinum toxin injection was not effective in randomized controlled trials. Most of these treatments are based on open-label treatment trials and small numbers. Partial gastrectomy and pyloroplasty should be used rarely, only in carefully selected patients. Attention should be given to the development of new effective therapies for
Jiménez Carnicero, M P; Magallón, A I; Gordillo, A
Background. Until 2004, requests for clinical documentation proceeding from the Judicial Administration on Specialist Care of Pamplona were received in six different centres and were processed independently, with different procedures, and documents were even sent in duplicate, with the resulting work load. This article describes the procedure for processing requests for documentation proceeding from the Law Courts and analyses the requests received. Methods. A circuit was set up to channel the judicial requests that arrived at the Specialist Health Care Centres of Pamplona and at the Juridical Regime Service of the Health System of Navarra-Osasunbidea, and a Higher Technician in Health Documentation was contracted to centralise these requests. A proceedings protocol was established to unify criteria and speed up the process, and a database was designed to register the proceedings. Results. In the course of 2004, 210 requests for documentation by legal requirement were received. Of these, 24 were claims of patrimonial responsibility and 13 were requested by lawyers with the patient's authorisation. The most frequent jurisdictional order was penal (43.33%). Ninety-three point one five percent (93.15%) of the requests proceeded from law courts in the autonomous community of Navarra. The centre that received the greatest number of requests was the "Príncipe de Viana" Consultation Centre (33.73%).The most frequently requested documentation was a copy of reports (109) and a copy of the complete clinical record (39). On two occasions the original clinical record was required. The average time of response was 6.6 days. Conclusions. The centralisation of administration has brought greater agility to the process and homogeneity in the criteria of processing. Less time is involved in preparing and dispatching the documentation, the dispatch of duplicate documents is avoided, the work load has been reduced and the dispersal of documentation is avoided, a situation that
Urbanowitsch, Nadja; Gorenc, Lina; Herold, Christina J; Schröder, Johannes
Autobiographical memory (ABM) comprises memories of one's own past that are characterized by a sense of subjective time and autonoetic awareness. Although ABM deficits are among the primary symptoms of patients with major psychiatric conditions such as mild cognitive impairment (MCI) and Alzheimer Disease (AD) or chronic schizophrenia large clinical studies are scarce. We therefore summarize and discuss the results of our clinical studies on ABM deficits in the respective conditions. In these studies ABM was assessed by using the same instrument - i.e., the Erweitertes Autobiographisches Gedächtnis Inventar (E-AGI) - thus allowing a direct comparison between diagnostic groups. Episodic ABM, especially the richness of details was impaired already in MCI and in beginning AD. Semantic memories were spared until moderate stages, indicating a dissociation between both memory systems. A recency effect was detectable in cognitively unimpaired subjects and vanished in patients with AD. A similar pattern of deficits was found in patients with chronic schizophrenia but not in patients with major depression. These ABM deficits were not accounted for by gender, or education level and did not apply for the physiological ageing process in otherwise healthy elderly. In conclusion, ABM deficits are frequently found in AD and chronic schizophrenia and primarily involve episodic rather than semantic memories. This dissociation corresponds to the multiple trace theory which hypothesized that these memory functions refer to distinct neuronal systems. The semi-structured interview E-AGI used to discern ABM changes provided a sufficient reliability measures, moreover potential effects of a number of important confounders could be falsified so far. These findings underline the relevance of ABM-assessments in clinical practice.
Dicpinigaitis, Peter V
Cough is among the most common complaints for which patients worldwide seek medical attention. Thus, the evaluation and treatment of cough result in tremendous financial expenditure and consumption of health care resources. Yet, despite the clinical significance of cough, research efforts aimed at improving diagnostic capabilities and developing more effective therapeutic agents have been, to date, disappointing in their limited scope and outcomes. Acute cough due to the common cold represents the most common type of cough. Currently, available medications for the symptomatic management of acute cough are inadequate due to lack of proven efficacy and/or their association with undesirable or intolerable side effects at anti-tussive doses. Subacute cough, often representing a prolonged post-viral response, is typically refractory to standard anti-tussive therapy. Few clinical trials have evaluated therapeutic options for subacute cough. Diagnostic challenges facing the clinician in the management of chronic cough include the determination of whether symptoms of upper airway cough syndrome (formerly, postnasal drip syndrome) or gastro-oesophageal reflux disease are indeed the underlying cause of cough. Chronic, refractory unexplained (formerly, idiopathic) cough must be distinguished from cough that has not been fully evaluated and treated according to current guideline recommendations. Eagerly awaited are new safe and effective anti-tussive agents for use when cough suppression is desired, regardless of underlying aetiology of cough, as well as practical, validated ambulatory cough counters to aid clinical assessment and future research in the field of cough. LINKED ARTICLES This article is part of a themed issue on Respiratory Pharmacology. To view the other articles in this issue visit http://dx.doi.org/10.1111/bph.2011.163.issue-1 PMID:21198555
Objective The management of cervical intraepithelial neoplasia (CIN) and early invasive cancer of the uterine cervix is very difficult to approach, especially in case of young woman who wants to preserve her fertility. Conization of the cervix may have various kinds of disadvantage. The objective of this clinical retrospective study is to investigate the therapeutic effects and clinical efficacy of photodynamic therapy (PDT) including combined chemo-photodynamic therapy in patients with pre-malignant CIN and malignant invasive cervical cancer. Methods Total number of PDT trial case was 50 cases and total number of patient was 22 patients who registered to PDT clinic. We used photogem sensitizer and 632 nm diode laser in early two cases. After then we performed PDT using photofrin sensitizer and 630 nm diode laser in other cases. We used flat-cut, microlens, cylindrical diffuser, and interstitial type optic fibers in order to irradiate the lesions. 240 J/cm2 energy was irradiated to the lesions. Results CIN 2 were 4 cases (18.2%) and CIN 3 were 15 (68.2%) and invasive cervical cancer were 3 (13.6%). Complete remission (CR) was found in 20 patients (91%). One case of 19 patients with CIN lesion recurred at 18 months after PDT treatment. CR was found in 18 cases in the patients with CIN lesions (95%). CR was found in 2 cases in the patients with invasive cervical cancer (67%). Conclusion Our data showed that CR rate was fantastic in CIN group (95%). This study suggests that PDT can be recommended as new optimistic management modality on the patients with pre-malignant CIN lesions including carcinoma in situ and relatively early invasive cancer of the uterine cervix. Combined chemo-photodynamic therapy is essential in case of invasive cervical cancer. For the young age group who desperately want to preserve their fertility and have a healthy baby, PDT can be a beacon of hope. PMID:27896250
Ekincioğlu, Aygin Bayraktar; Demirkan, Kutay
A drug’s plasma level, pharmacological effects or side effects, elimination, physicochemical properties or stability could be changed by interactions of drug-drug or drug-nutrition products in patients who receive enteral or parenteral nutritional support. As a result, patients might experience ineffective outcomes or unexpected effects of therapy (such as drug toxicity, embolism). Stability or incompatibility problems between parenteral nutrition admixtures and drugs might lead to alterations in expected therapeutic responses from drug and/or parenteral nutrition, occlusion in venous catheter or symptoms or mortality due to infusion of composed particles. Compatibilities between parenteral nutrition and drugs are not always guaranteed in clinical practice. Although the list of compatibility or incompatibilities of drugs are published for the use of clinicians in their practices, factors such as composition of parenteral nutrition admixture, drug concentration, contact time in catheter, temperature of the environment and exposure to light could change the status of compatibilities between drugs and nutrition admixtures. There could be substantial clinical changes occurring in the patient’s nutritional status and pharmacological effects of drugs due to interactions between enteral nutrition and drugs. Drug toxicity and ineffective nutritional support might occur as a result of those predictable interactions. Although administration of drugs via feeding tube is a complex and problematic route for drug usage, it is possible to minimise the risk of tube occlusion, decreased effects of drug and drug toxicity by using an appropriate technique. Therefore, it is important to consider pharmacological dosage forms of drugs while administering drugs via a feeding tube. In conclusion, since the pharmacists are well-experienced and more knowledgeable professionals in drugs and drug usage compared to other healthcare providers, it is suggested that provision of information
Aim of the study The technological progress that is currently being witnessed in the areas of diagnostic imaging, treatment planning systems and therapeutic equipment has caused radiotherapy to become a high-tech and interdisciplinary domain involving staff of various backgrounds. This allows steady improvement in therapy results, but at the same time makes the diagnostic, imaging and therapeutic processes more complex and complicated, requiring every stage of those processes to be planned, organized, controlled and improved so as to assure high quality of services provided. The aim of this paper is to present clinical quality standards for radiotherapy as developed by the author. Material and methods In order to develop the quality standards, a comparative analysis was performed between European and Polish legal acts adopted in the period of 1980-2006 and the universal industrial ISO 9001:2008 standard, defining requirements for quality management systems, and relevant articles published in 1984-2009 were reviewed, including applicable guidelines and recommendations of American, international, European and Polish bodies, such as the American Association of Physicists in Medicine (AAPM), the European Society for Radiotherapy & Oncology (ESTRO), the International Atomic Energy Agency (IAEA), and the Organisation of European Cancer Institutes (OECI) on quality assurance and management in radiotherapy. Results As a result, 352 quality standards for radiotherapy were developed and categorized into the following three groups: 1 – organizational standards; 2 – physico-technical standards and 3 – clinical standards. Conclusion Proposed clinical quality standards for radiotherapy can be used by any institution using ionizing radiation for medical purposes. However, standards are of value only if they are implemented, reviewed, audited and improved, and if there is a clear mechanism in place to monitor and address failure to meet agreed standards. PMID:23788854
Network PRINCIPAL INVESTIGATOR: Patricia Zilliox., Ph.D. CONTRACTING ORGANIZATION: Foundation Fighting Blindness Clinical Research...fightblindness.org 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Foundation Fighting Blindness Clinical Research Institute
The Clinical Imaging Steering Committee serves as a forum for the extramural imaging and oncology communities to provide strategic input to the NCI regarding its significant investment in imaging activities in clinical trials.
... Contact us | Site Map | Staff Only About the Clinical Center Search the Studies Patient Information Education & Training ... Events Staff Directory Dr. John I. Gallin Director, Clinical Center, National Institutes of Health Welcome to the ...
Hubbell, Jeffrey A.; Langer, Robert
Many materials-based therapeutic systems have reached the clinic or are in clinical trials. Here we describe materials design principles and the construction of delivery vehicles, as well as their adaptation and evaluation for human use.
Information about actively enrolling, ongoing, and completed clinical trials of cancer prevention, early detection, and supportive care, including phase I, II, and III agent and action trials and clinical trials management. |
Félix Mañes Ferrer, J; Micò Muñoz, P; Sánchez Cortés, J L; Paricio Martín, J J; Miñana Laliga, R
The aim of the study is to present a clinical review of the vertical root fractures. Two clinical cases are presented to demonstrates the criteria for obtaining a correct diagnosis of vertical root fractures.
Datz, F.L.; Christian, P.E.; Baker, W.J.
Platelets were first successfully radiolabeled in 1953. At that time, investigators were primarily interested in developing a technique to accurately measure platelet life span in both normal and thrombocytopenic patients. Studies using platelets labeled with /sup 51/Cr have shown shortened platelet survival times in a number of diseases including idiopathic thrombocytopenic purpura, coronary artery disease, and diabetes mellitus. More recently, labels such as /sup 111/In have been developed that allow in vivo imaging of platelets. Indium-111 platelets are being used to better understand the pathophysiology of atherosclerosis, thrombophlebitis, pulmonary embolism and clotting disorders, and to improve the clinical diagnosis of these diseases.
Wing, J K
In summary, the discussion by Professors Helmchen and Müller-Oerlinghausen of the morality of clinical trials has emphasized a point that is frequently overlooked. It is an essential to consider those situations in which it might be unethical not to conduct a trial as it is to be concerned about the ways in which trials might restrict the rights of the individuals taking part in them. They and I have dealt mainly with the first of these two issues because it has been relatively neglected. The second is, of course, equally important and has rightly received much attention. Both matters deserve further public discussion. PMID:775090
Wing, J K
In summary, the discussion by Professors Helmchen and Müller-Oerlinghausen of the morality of clinical trials has emphasized a point that is frequently overlooked. It is an essential to consider those situations in which it might be unethical not to conduct a trial as it is to be concerned about the ways in which trials might restrict the rights of the individuals taking part in them. They and I have dealt mainly with the first of these two issues because it has been relatively neglected. The second is, of course, equally important and has rightly received much attention. Both matters deserve further public discussion.
This paper presents a brief introduction to the techniques, methods and tools used to implement clinical systems. It begins with a taxonomy of software systems, describes the classic approach to development, provides some guidelines for the planning and management of software projects, and finishes with a guide to further reading. The conclusions are that there is no single right way to develop software, that most decisions are based upon judgment built from experience, and that there are tools that can automate some of the better understood tasks.
Schuler, A L
Echolalic behaviors have been reported within the context of various pathologies but have remained poorly defined. Consequently, it is not easy to determine whether and to what extent normal repetition can be separated from pathological echoing. Hence, it is unclear whether the occurrence of echolalic behavior may be useful for differential diagnostic purposes. Also, much room is left for controversies about the clinical management of echolalic behavior. This article reviews the various conditions associated with echolalia and the role of repetitions in normal language behavior. Suggestions are made in terms of the various dimensions along which echolalic behavior should be assessed, as well as of the desirability of particular intervention techniques.
Key manifestations helpful in diagnosing Rett syndrome include progressive loss of previously acquired psychomotor skills, apraxia with loss of use of hands and legs, and "handwashing" automatisms. Four types of clinical presentation can be described: a neurodegenerative disorder, an autistic syndrome, a Lennox-Gastaut syndrome, and a chronic encephalopathy. Carbamazepine currently appears to be the anticonvulsant of choice. The mild lactic and pyruvic acidosis along with the ultrastructural abnormalities of mitochondria in brain and liver biopsies point to a generalized disorder of energy metabolism.
Hart, M; Hooper, G
Dupuytren's disease (DD) is a common progressive fibrotic condition affecting the palmar and digital fascia. Although its management is undertaken by hand surgeons, it is commonly seen by other doctors as an incidental finding. In many cases it is believed to be associated with other medical conditions, although the evidence for such associations is not always clear. This review considers the evidence behind these associations and discusses the aetiology of DD. By doing so, it is hoped that this review will permit a better understanding of the relevance of DD as a clinical sign. PMID:15998816
Scolari, Maria Piera; Comai, G; La Manna, G; Liviano D'Arcangelo, G; Monti, M; Feliciangeli, G; Stefoni, S
When possible, living donor transplantation represents the best therapeutic strategy for patients suffering from chronic renal failure. Studying the donor allows a complete and thorough clinical, laboratory and instrumental assessment that guarantees good organ function whilst protecting the health of the donor. The main parameters considered within this framework are age, renal function, nephrological complications, comorbidities (diabetes, hypertension, obesity, etc.), malignancies, and infection. Moreover, particular attention is paid to the sociopsychological aspects of the donation, particularly related to the donor, the recipient, and the entire family situation.
Veterinary clinical oncology involves a multidisciplinary approach to the recognition and management of spontaneously occurring neoplasms of domestic animals. This requires some knowledge of the causes, incidence, and natural course of malignant disease as it occurs in domestic species. The purpose of this course is to acquaint you with the more common neoplastic problems you will encounter in practice, so that you can offer your clients an informed opinion regarding prognosis and possible therapeutic modalities. A major thrust will be directed toward discussing and encouraging treatment/management of malignant disease. Multimodality therapy will be stressed. 10 refs., 3 tabs.
Anu, Sharma; Gayatri, Sharma
Ceramics are the inorganic crystalline material. These are used in various field such as biomedical, electrical, electronics, aerospace, automotive and optical etc. Bio ceramics are the one of the most active areas of research. Bio ceramics are the ceramics which are biocompatible. The unique properties of bio ceramics make them an attractive option for medical applications and offer some potential advantages over other materials. During the past three decades, a number of major advances have been made in the field of bio ceramics. This review focuses on the use of these materials in variety of clinical scenarios.
Andrews, Robert D.
Two prototype methods have been developed to aid in the presentation of relevant clinical data: 1) an integrated report that displays results from a patient's computer-stored data and also allows manual entry of data, and 2) a graph program that plots results of multiple kinds of tests. These reports provide a flexible means of displaying data to help evaluate patient treatment. The two methods also explore ways of integrating the display of data from multiple components of the Veterans Administration's (VA) Decentralized Hospital Computer Program (DHCP) database.
Martich, G Daniel; Waldmann, Carl S; Imhoff, Michael
Health care information systems have the potential to enable better care of patients in much the same manner as the widespread use of the automobile and telephone did in the early 20th century. The car and phone were rapidly accepted and embraced throughout the world when these breakthroughs occurred. However, the automation of health care with use of computerized information systems has not been as widely accepted and implemented as computer technology use in all other sectors of the global economy. In this article, the authors examine the need, risks, and rewards of clinical informatics in health care as well as its specific relationship to critical care medicine.
Yapko, M D; Barretta, N P; Barretta, P F
The authors place great value on the role of experiential learning in their clinical trainings on Ericksonian approaches to hypnosis. This article describes several of the principal skill-building exercises used in their training programs. These highly practical exercises are intended to facilitate: (a) developing sensory acuity, (b) developing flexibility in forming and delivering suggestions, (c) employing naturalistic methods, (d) employing reframings, and (e) embedding suggestions. A rationale and goal for each exercise are also presented in order to help create an appropriate context for its use.
Kushnir, S.; Banack, A. D.; Marks, C. P.
Hypnosis and trance states are as old as man himself. Over the years, many misconceptions concerning this phenomenon have arisen from lack of knowledge and misrepresentations in the literature and on the stage; however, these are being dispelled as more scientific research into the nature of hypnosis is undertaken. When applied in accordance with ethical principles, hypnotherapy has a very wide range of clinical applications, only one of which is psychotherapy. This overview of the current status of medical hypnosis includes a discussion of misconceptions, myths, and dangers, as well as an outline of common uses. PMID:20469081
Valdivies, Yusbiel José León; Sanchez de la Osa, Reinaldo Bárbaro; Barrera, Jany; Acosta, Carlos Enríquez
We described a patient who was diagnosed with a Pancoast tumor in the Neumológico Benéfico Jurídico Hospital. This neoplastic non metastatic disease more frequently affects the brachial plexus. Therefore, a differential diagnosis of the painful shoulder was carried out and the patient was admitted in our center with the probable Pancoast tumor diagnosis. Subsequently, its study continued and the clinical suspicion was confirmed by a computerized tomography and a magnetic resonance, to be also confirmed later on with an anatomopathological study.
Chakrabarti, Debaprasad; Roy, Mukut; Bhattacharyya, Amrit K
Bilateral facial paralysis is a rare clinical entity and presents as a diagnostic challenge. Unlike its unilateral counterpart facial diplegia is seldom secondary to Bell's palsy. Occurring at a frequency of 0.3% to 2% of all facial palsies it often indicates ominous medical conditions. Guillian-Barre syndrome needs to be considered as a differential in all given cases of facial diplegia where timely treatment would be rewarding. Here a case of bilateral facial palsy due to Guillian-Barre syndrome with atypical presentation is reported.
Weiler, Catherine R; Butterfield, Joseph
Mast cell sarcoma is a disorder that results in abnormal mast cells as identified by morphology, special stains, and in some publications, c-kit mutation analysis. It affects animal species such as canines more commonly than humans. In humans it is a very rare condition, with variable clinical presentation. There is no standard therapy for the disorder. It can affect any age group. It is occasionally associated with systemic mastocytosis and/or urticaria pigmentosa. The prognosis of mast cell sarcoma in published literature is very poor in humans.
Bercaw-Pratt, Jennifer L; Boardman, Lori A; Simms-Cendan, Judith S
Lichen sclerosus is a chronic inflammatory condition affecting the anogenital region that may present in the prepubertal or adolescent patient. Clinical presentations include significant pruritus, labial adhesions, and loss of pigmentation. Treatment includes topical anti-inflammatory agents and long-term follow-up as there is a high risk of recurrence and an increased risk of vulvar cancer in adult women with history of lichen sclerosus. These recommendations are intended for pediatricians, gynecologists, nurse practitioners and others who care for pediatric/adolescent girls in order to facilitate diagnosis and treatment.
Blum, C-L; Menzinger, S; Genné, D
Cellulitis is an acute bacterial non-necrotizing dermal-hypodermal infection predominantly affecting the lower limbs. It is characterised by a circumscribed erythema with a raised border and fever. The predisposing factors are skin wounds, edema from any cause and systemic factors (diabetes, immunosuppression). The diagnosis is clinical and the most common complication is recurrence. Other complications include local abscess, fasciitis and bacteremia. The germ is rarely identified. The majority of infections (85%) is due to group A beta-hemolytic streptococcus. The treatment of cellulitis consists of an association of an antibiotic with rest of the concerned area.
Jones, Richard G; Johnson, Owen A; Batstone, Gifford
The nature of pathology services is changing under the combined pressures of increasing workloads, cost constraints and technological advancement. In the face of this, laboratory systems need to meet new demands for data exchange with clinical electronic record systems for test requesting and results reporting. As these needs develop, new challenges are emerging especially with respect to the format and content of the datasets which are being exchanged. If the potential for the inclusion of intelligent systems in both these areas is to be realised, the continued dialogue between clinicians and laboratory information specialists is of paramount importance. Requirements of information technology (IT) in pathology, now extend well beyond the provision of purely analytical data. With the aim of achieving seamless integration of laboratory data into the total clinical pathway, ‘Informatics’ – the art and science of turning data into useful information – is becoming increasingly important in laboratory medicine. Informatics is a powerful tool in pathology – whether in implementing processes for pathology modernisation, introducing new diagnostic modalities (e.g. proteomics, genomics), providing timely and evidence-based disease management, or enabling best use of limited and often costly resources. Providing appropriate information to empowered and interested patients – which requires critical assessment of the ever-increasing volume of information available – can also benefit greatly from appropriate use of informatics in enhancing self-management of long term conditions. The increasing demands placed on pathology information systems in the context of wider developmental change in healthcare delivery are explored in this review. General trends in medical informatics are reflected in current priorities for laboratory medicine, including the need for unified electronic records, computerised order entry, data security and recovery, and audit. We conclude that
Pace, Christine A; Samet, Jeffrey H
This issue provides a clinical overview of substance use disorders, focusing on epidemiology, prevention, diagnosis, complications, and management. The content of In the Clinic is drawn from the clinical information and education resources of the American College of Physicians (ACP), including MKSAP (Medical Knowledge and Self-Assessment Program). Annals of Internal Medicine editors develop In the Clinic in collaboration with the ACP's Medical Education and Publishing divisions and with the assistance of additional science writers and physician writers.
The Association of Clinical Embryologists (ACE) is the professional body of and for clinical embryologists practising in the UK. ACE was founded in 1993 to promote high standards of practice in clinical embryology and to support the professional interests of embryologists. ACE presently has in excess of 400 members.
Greist, John H.; Klein, Marjorie H.; Erdman, Harold P.; Jefferson, James W.
Direct patient-computer interviews were among the earliest applications of computing in medicine. Yet patient interviewing and other clinical applications have lagged behind fiscal/administrative uses. Several reasons for delays in the development and implementation of clinical computing programs and their resolution are discussed. Patient interviewing, clinician consultation and other applications of clinical computing in mental health are reviewed.
To make clinicians aware of potential sources of error in ophthalmic pharmaceutical clinical trials that can lead to erroneous interpretation of results, a critical review of the study design of various pharmaceutical ophthalmic clinical trials was completed. Discrepancies as a result of study shortcomings may explain observed differences between reported ophthalmic trial data and observed clinical results. PMID:19668731
Laske, Rita Ann
Clinical education provides the nursing student opportunities to learn the practice of nursing. In the clinical setting, the nursing student applies classroom knowledge to the real patient care situation. The clinical instructor facilitates this important process by assisting students to integrate knowledge into their practice, improve their…
Henning, John E.; Erb, Dorothy J.; Randles, Halle Schoener; Fults, Nanette; Webb, Kathy
The purpose of this article is to describe a collaborative effort among five teacher preparation programs to create a conceptual tool designed to put clinical experiences at the center of our programs. The authors refer to the resulting product as a clinical curriculum. The clinical curriculum describes a developmental sequence of clinical…
Allan, Julaine; Pope, Rod; O'Meara, Peter; Higgs, Joy; Kent, Jenny
Aim: To effectively provide clinical placements for students and increase healthcare options for rural communities, an investigation of university clinics was conducted. Method: This project adopted a consultative inquiry strategy and involved two processes: (1) a review of literature; and (2) interviews with existing health sciences clinic staff.…
Rogers, R; Nussbaum, D; Gillis, R
Clinical literature on the role of command hallucinations in producing antisocial behavior is sparse and fragmented. This article reviews exploratory models of auditory hallucinations and the prevalence of command hallucinations in clinical and forensic settings. In addition, clinical guidelines are offered for assessing the authenticity of command hallucinations and their relevance to criminal behavior within the context of forensic evaluations.
In this paper, I explore how we might link ideas about clinical facts to current issues in child psychotherapy research. I consider what our understanding of clinical facts might contribute to our research methods and how our research methods might better represent the clinical facts. The paper introduces a selection of psychoanalytic writers'…
... 42 Public Health 1 2010-10-01 2010-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...
... 42 Public Health 1 2011-10-01 2011-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...
... 42 Public Health 1 2013-10-01 2013-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...
... 42 Public Health 1 2014-10-01 2014-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...
... 42 Public Health 1 2012-10-01 2012-10-01 false Vaccination clinics. 70.9 Section 70.9 Public... INTERSTATE QUARANTINE § 70.9 Vaccination clinics. (a) The Director may establish vaccination clinics, through contract or otherwise, authorized to administer vaccines and/or other prophylaxis. (b) A vaccination...
... HUMAN SERVICES Food and Drug Administration Clinical Investigator Training Course AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration's (FDA's) Center for Drug Evaluation and... in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials;...
Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials.
The European Society for Clinical Virology annual winter meeting mainly appeals to clinical virologists interested in human disease. Basic and clinical data were presented, highlighting a number of interesting findings. This report briefly describes options in HIV antiviral treatment, and focuses on fusion inhibitors, a new anti-HIV class of drugs. Recent improvements in experimental DNA vaccines are also presented.
As a result of painstaking studies carried out over a period of almost 30 years, the German neurologist and psychiatrist Hans Berger, of Jena, published the first paper on the human electroencephalogram (Uber das Elektrenkephalogramm des Menschen') in 1929. Clinical electroencephalography, which reached a zenith in the 1950s and 1960s, increased the range of diagnostic techniques available for a series of brain diseases and revolutionized the study of epilepsy. Today, conventional electroencephalography no longer yields startling scientific discoveries. Nor can it complete with computer tomography and magnetic resonance imaging, in the diagnosis of structural disorders of the brain. In spite of this, the scope of its uses continues to increase and it remains an indispensable instrument of neurophysiological diagnosis, especially in its capacity as a 'seismograph' of the brain. The trend that is apparent throughout the world to cut back clinical electroencephalographic units in favor of other neurophysiological investigative techniques is both unjustified and dangerous. If it continues, it will inevitably lead to a decline in epileptology, which is an essential part of the work of many different medical specialists both in practice and in hospitals.
Ballas, S K
Sickle cell syndromes are a group of inherited disorders of haemoglobin structure that have no cure in adults at the present time. Bone marrow transplantation in children has been shown to be curative in selected patients. The phenotypic expression of these disorders and their clinical severity vary greatly among patients and longitudinally in the same patient. They are multisystem disorders and influence all aspects of the life of affected individuals including social interactions, family relations, peer interaction, intimate relationships, education, employment, spiritual attitudes and navigating the complexities of the health care system, providers and their ancillary functions. The clinical manifestations of these syndromes are protean. In this review emphasis is placed on four sets of major complications of these syndromes and their management. The first set pertains to the management of anaemia and its sequelae; the second set addresses painful syndromes both acute and chronic; the third set discusses infections; the fourth section deals with organ failure. New experimental therapies for these disorders are briefly mentioned at the end. Efforts were made to include several tables and figures to clarify the message of this review.
Helfenstein Jr, Milton; Goldenfum, Marco Aurélio; Siena, César Augusto Fávaro
Fibromyalgia (FM) is a clinical syndrome commonly observed in daily medical practice and its etiopathogenesis is still unclear. As it is characterized by chronic musculoskeletal pain associated with several symptoms, FM may be confused with several other rheumatic and nonrheumatic diseases when they course with pictures of diffuse pain and chronic fatigue. FM treatment should be multidisciplinary, individualized, count on active participation of the patient, and based on combined pharmacological and nonpharmacological modalities. It is found both in work and non-work settings, and there is no scientific evidence in the literature showing that FM might be caused by occupation. FM seldom leads to incapacity to work. In cases where pain or fatigue do not respond to appropriate treatment, reaching significant levels, a short period away from work can be considered. As FM is a relevant subject, this review article was based on exploratory, qualitative, and bibliographic investigation, aiming to study the main clinical and occupational aspects of FM, emphasizing the theoretical-conceptual background and the experience of specialists.
Jung, Kyu Sik
Chronic liver disease represents a major public health problem, accounting for significant morbidity and mortality worldwide. As prognosis and management depend mainly on the amount and progression of liver fibrosis, accurate quantification of liver fibrosis is essential for therapeutic decision-making and follow-up of chronic liver diseases. Even though liver biopsy is the gold standard for evaluation of liver fibrosis, non-invasive methods that could substitute for invasive procedures have been investigated during past decades. Transient elastography (TE, FibroScan®) is a novel non-invasive method for assessment of liver fibrosis with chronic liver disease. TE can be performed in the outpatient clinic with immediate results and excellent reproducibility. Its diagnostic accuracy for assessment of liver fibrosis has been demonstrated in patients with chronic viral hepatitis; as a result, unnecessary liver biopsy could be avoided in some patients. Moreover, due to its excellent patient acceptance, TE could be used for monitoring disease progression or predicting development of liver-related complications. This review aims at discussing the usefulness of TE in clinical practice. PMID:22893866
Mandal, Malay; Mandal, Amritlal; Das, Sudip; Chakraborti, Tapati; Sajal, Chakraborti
Matrix metalloproteinases (MMPs) are a family of neutral proteinases that are important for normal development, wound healing, and a wide variety of pathological processes, including the spread of metastatic cancer cells, arthritic destruction of joints, atherosclerosis, pulmonary fibrosis, emphysema and neuroinflammation. In the central nervous system (CNS), MMPs have been shown to degrade components of the basal lamina, leading to disruption of the blood brain barrier and to contribute to the neuroinflammatory responses in many neurological diseases. Inhibition of MMPs have been shown to prevent progression of these diseases. Currently, certain MMP inhibitors have entered into clinical trials. A goal to the future should be to design selective synthetic inhibitors of MMPs that have minimum side effects. MMP inhibitors are designed in such a way that these can not only bind at the active site of the proteinases but also to have the characteristics to bind to other sites of MMPs which might be a promising route for therapy. To name a few: catechins, a component isolated from green tea; and Novastal, derived from extracts of shark cartilage are currently in clinical trials for the treatment of MMP-mediated diseases.
Handoo, Anil; Sood, Swaroop Krishan
Test results from clinical laboratories must ensure accuracy, as these are crucial in several areas of health care. It is necessary that the laboratory implements quality assurance to achieve this goal. The implementation of quality should be audited by independent bodies,referred to as accreditation bodies. Accreditation is a third-party attestation by an authoritative body, which certifies that the applicant laboratory meets quality requirements of accreditation body and has demonstrated its competence to carry out specific tasks. Although in most of the countries,accreditation is mandatory, in India it is voluntary. The quality requirements are described in standards developed by many accreditation organizations. The internationally acceptable standard for clinical laboratories is ISO15189, which is based on ISO/IEC standard 17025. The accreditation body in India is the National Accreditation Board for Testing and Calibration Laboratories, which has signed Mutual Recognition Agreement with the regional cooperation the Asia Pacific Laboratory Accreditation Cooperation and with the apex cooperation the International Laboratory Accreditation Cooperation.
Levy, Julia G.; Chan, Agnes H.; Strong, H. Andrew
Benzoporphyrin derivative monoacid ring A (BPD) is currently in Phase II clinical trials for the treatment of cutaneous malignancies (basal cell carcinoma and cutaneous metastases) and psoriasis. Results to date suggest that this photosensitizer has potential in both of these areas. Recently, a clinical trial with BPD was initiated for the treatment of age related macular degeneration, a neovascular condition in the eye which leads to blindness. BPD is a lipophilic photosensitizer which is rapidly taken up by activated cells and the vascular endothelium of neovasculature. The PDT effects seen with BPD appear to be a combination of vascular occlusion and direct killing of target cells. Since many diseases involve either activated cells and/or neovasculature, PDT with photosensitizer with characteristics like those of BPD, has applications far wider than oncology. A new area of interest involving photosensitizers is that of immune modulation. A number of photosensitizers have been shown to effect immune modulation in animal models of immune dysfunction including autoimmunity (rheumatoid arthritis, lupus), cutaneous hypersensitivity and allografts. BPD and PHOTOFRINR have both been shown to be effective in ameliorating arthritic symptoms in a number of animal models. The mechanisms by which immune modulation is affected in these studies still remains to be resolved.
Voora, Deepak; Ginsburg, Geoffrey S
Pharmacogenetics primarily uses genetic variation to identify subgroups of patients who may respond differently to a certain medication. Since its first description, the field of pharmacogenetics has expanded to study a broad range of cardiovascular drugs and has become a mainstream research discipline. Three principle classes of pharmacogenetic markers have emerged: 1) pharmacokinetic; 2) pharmacodynamic; and 3) underlying disease mechanism. In the realm of cardiovascular pharmacogenetics, significant advances have identified markers in each class for a variety of therapeutics, some with a potential for improving patient outcomes. While ongoing clinical trials will determine if routine use of pharmacogenetic testing may be beneficial, the data today support pharmacogenetic testing for certain variants on an individualized, case-by-case basis. Our primary goal is to review the association data for the major pharmacogenetic variants associated with commonly used cardiovascular medications: antiplatelet agents, warfarin, statins, beta-blockers, diuretics, and antiarrhythmic drugs. In addition, we highlight which variants and in which contexts pharmacogenetic testing can be implemented by practicing clinicians. The pace of genetic discovery has outstripped the generation of the evidence justifying its clinical adoption. Until the evidentiary gaps are filled, however, clinicians may choose to target therapeutics to individual patients whose genetic background indicates that they stand to benefit the most from pharmacogenetic testing.
Talamonti, C.; Reggioli, V.; Bruzzi, M.; Bucciolini, M.; Civinini, C.; Marrazzo, L.; Menichelli, D.; Pallotta, S.; Randazzo, N.; Sipala, V.; Cirrone, G. A. P.; Petterson, M.; Blumenkrantz, N.; Feldt, J.; Heimann, J.; Lucia, D.; Seiden, A.; Williams, D. C.; Sadrozinski, H. F.-W.; Bashkirov, V.; Schulte, R.
Proton imaging is not yet applied as a clinical routine, although its advantages have been demonstrated. In the context of quality assurance in proton therapy, proton images can be used to verify the correct positioning of the patient and to control the range of protons. Proton computed tomography (pCT) is a 3D imaging method appropriate for planning and verification of proton radiation treatments, because it allows evaluating the distributions of proton stopping power within the tissues and can be directly utilized when the patient is in the actual treatment position. The aim of the PRoton IMAging experiment, supported by INFN, and the PRIN 2006 project, supported by MIUR, is to realize a proton computed radiography (pCR) prototype for reconstruction of proton images from a single projection in order to validate the technique with pre-clinical studies and, eventually, to conceive the configuration of a complete pCT system. A preliminary experiment performed at the 250 MeV proton synchrotron of Loma Linda University Medical Center (LLUMC) allowed acquisition of experimental data before the completion of PRIMA project's prototype. In this paper, the results of the LLUMC experiment are reported and the reconstruction of proton images of two phantoms is discussed.
Ten Cate, Hugo
Commercial assays for determining thrombin generation in plasma are being tested in clinical conditions associated with thrombosis or bleeding. While pre-analytical conditions remain a source of inter laboratory variation, demanding for further standardization, clinical research proceeds. In patients at risk of venous thrombosis thrombin generation (TG) analysis may be utilized to detect underlying thrombophilia and this has been achieved both with addition of thrombomodulin or activated protein C, to test the contribution of the protein C system. In patients with documented venous thromboembolism, increased TG values are seen in those patients at greatest risk for recurrence, although the data are not consistent yet. In patients with arterial vascular disease, effects on TG patterns are seen that both reflect atherosclerosis (and its risk factors) and link to risk of recurrent atherothrombosis (coronary or stroke), but the data are limited. In patients with a bleeding diathesis, like hemophilia, the main importance of TG assays lies in the application for monitoring replacement therapy, either with factor concentrate or rFVIIa. An interesting application is in conjunction with thromboelastography, for monitoring peri-operative transfusion policy. Finally, TG analysis may contribute to monitoring anticoagulant drug treatment, but these and other applications would greatly benefit from whole blood, point of care applications of TG testing.
Resnik, David B; Ness, Elizabeth
Discussions on the ethics and regulation of clinical research have a great deal to say about the responsibilities of investigators, sponsors, research institutions and institutional review boards, but very little about the responsibilities of research participants. In this article, we discuss the responsibilities of participants in clinical research. We argue that competent adult participants are responsible for complying with study requirements and fulfilling other obligations they undertake when they make an informed choice to enroll in a study. These responsibilities are based on duties related to promise-keeping, avoiding harm to one's self or others, beneficence and reciprocity. Investigators and research staff should inform participants about their responsibilities during the consent process, and should stress the importance of fulfilling study requirements. They should address any impediments to compliance, and they may provide participants with financial incentives for meeting study requirements. In very rare cases, coercive measures may be justified to prevent immanent harm to others resulting from non-compliance with study requirements.
Henke, Rachel M.; Zaslavsky, Alan M.; McGuire, Thomas G.; Ayanian, John Z.; Rubenstein, Lisa V.
Objective To explore reasons for clinical inertia in the management of persistent depression symptoms. Research Design We characterized patterns of treatment adjustment in primary care and their relation to the patient’s clinical condition by modeling transition to a given treatment “state” conditional upon the current state of treatment. We assessed associations of patient, clinician, and practice barriers with adjustment decisions. Subjects Survey data on patients in active care for major depression was collected at six-month intervals over a two-year period for the Quality Improvement for Depression (QID) studies. Measures Patient and clinician characteristics were collected at baseline. Depression severity and treatment were measured at each interval. Results Approximately one-third of the observation periods ending with less than a full response resulted in an adjustment recommendation. Clinicians often respond correctly to the combination of severe depression symptoms and less than maximal treatment by changing the treatment. Appropriate adjustment is less common, however, in management of less severely depressed patients who do not improve after starting treatment, particularly if their care already meets minimal treatment intensity guidelines. Conclusions Our findings suggest that quality improvement efforts should focus on promoting appropriate adjustments for patients with persistent depression symptoms, particularly those with less severe depression. PMID:19704353
Tong, Yi Cai Isaac; Kaye, Alan David; Urman, Richard D
In the multimodal approach to the management of postoperative pain, local infiltration and regional blocks have been increasingly utilized for pain control. One of the limitations of local anesthetics in the postoperative setting is its relatively short duration of action. Multivesicular liposomes containing bupivacaine have been increasingly utilized for their increased duration of action. Compared with bupivacaine HCl, local infiltration of liposomal bupivacaine has shown to have an increase in duration of action and causes delay in peak plasma concentration. In this article, we attempt to review the clinical literature surrounding liposomal bupivacaine and its evolving role in perioperative analgesia. This new bupivacaine formation may have promising implications in postoperative pain control, resulting in increased patient satisfaction and a decrease in both hospital stay and opioid-induced adverse events (AEs). Although more studies are needed, the preliminary clinical trials suggest that liposomal bupivacaine has predictable pharmacokinetics, a similar side effect profile compared with bupivacaine HCl, and is effective in providing increased postoperative pain control.
Rogers, Geraint B; Shaw, Dominick; Marsh, Robyn L; Carroll, Mary P; Serisier, David J; Bruce, Kenneth D
Over the last decade, technological advances have revolutionised efforts to understand the role played by microbes in airways disease. With the application of ever more sophisticated techniques, the literature has become increasingly inaccessible to the non-specialist reader, potentially hampering the translation of these gains into improvements in patient care. In this article, we set out the key principles underpinning microbiota research in respiratory contexts and provide practical guidance on how best such studies can be designed, executed and interpreted. We examine how an understanding of the respiratory microbiota both challenges fundamental assumptions and provides novel clinical insights into lung disease, and we set out a number of important targets for ongoing research. PMID:26304986
In order to enable Masters level pre-registration students to demonstrate sophisticated cognitive abilities, integration of knowledge, complex problem solving, critical opinion, lateral thinking and innovative action; an innovative assessment tool is required (Sadler, 2009). A clinical viva was devised to enable third year students in their final transitional placement prior to qualifying demonstrate both the art and science of nursing practice. The assessment combines some of the viva element of an Australian assessment model described by Levett-Jones et al. (2011), together with the think aloud approach suggested by Banning (2008); whereby the think aloud model acts as a catalyst for eliciting students' understandings and knowledge and the SOAP model is a mechanism for the assessment of students' understandings and knowledge. Rust (2002) calls for students to be afforded opportunities for regular formative feedback; therefore, the assessment includes a replica formative assessment, one week prior to the summative assessment. This formative test prevents assessment being seen as a snapshot of the student's development and encourages assessment for learning and is an approach which is suggested to discourage surface learning (Rust, 2002). A holistic rubric was developed in an attempt to capture the students' abilities against the six cognitive operators or heuristics suggested by Banning (2008). Open-ended questions were devised to be asked of the students as advocated by Levett-Jones et al. (2011), to uncover the student's cognitive abilities, integration of knowledge, complex problem solving, critical opinion, lateral thinking and innovative action. Roberts (2011) calls for new and innovative ways of assessing student learning which bridges the artificial divide between theory and practice and enables students to demonstrate both the art and science of nursing practice (p610). The clinical viva has the potential to be one such mechanism.
Kealy, David; Ogrodniczuk, John S
Pathological narcissism is associated with significant interpersonal problems, which are unlikely to be acknowledged by narcissistic patients as clinical issues. Although a substantial clinical and theoretical literature deals with narcissism, a succinct overview of core narcissistic interpersonal problems is lacking, particularly in terms of their presentation in clinical settings. This article provides a descriptive overview of the major types of interpersonal problems associated with pathological narcissism: dominance, vindictiveness, and intrusiveness. We outline how these problems can manifest in patients' relations with others and in treatment situations. Clinical vignettes are provided to highlight the presentation of narcissistic interpersonal dysfunction in various types of clinical encounters, and to facilitate discussion of treatment implications.
Sirintrapun, S Joseph; Zehir, Ahmet; Syed, Aijazuddin; Gao, JianJiong; Schultz, Nikolaus; Cheng, Donavan T
Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations.
Sirintrapun, S Joseph; Zehir, Ahmet; Syed, Aijazuddin; Gao, JianJiong; Schultz, Nikolaus; Cheng, Donavan T
Translational bioinformatics and clinical research (biomedical) informatics are the primary domains related to informatics activities that support translational research. Translational bioinformatics focuses on computational techniques in genetics, molecular biology, and systems biology. Clinical research (biomedical) informatics involves the use of informatics in discovery and management of new knowledge relating to health and disease. This article details 3 projects that are hybrid applications of translational bioinformatics and clinical research (biomedical) informatics: The Cancer Genome Atlas, the cBioPortal for Cancer Genomics, and the Memorial Sloan Kettering Cancer Center clinical variants and results database, all designed to facilitate insights into cancer biology and clinical/therapeutic correlations.
Paterson, B; Groening, M
Although it is acknowledged that clinical teaching is an interpersonal process that is relational in nature, little has been written regarding the conflicts and feelings that can exist within the student-teacher relationship. The article is a discussion of the concept of countertransference in psychotherapy, specifically as to how it may be applied to understanding clinical teachers' subjective responses to students. The authors present arguments to support the fit between the concept of countertransference and clinical teaching, focusing on the negative effects of a teacher's countertransference in clinical teaching. The implications of the concept of countertransference in clinical nursing education is explored.
Clinical growth is an essential component of nursing education, although challenging to evaluate. Considering the paradigm shift toward constructivism and student-centered learning, clinical growth requires an examination within contemporary practices. A concept analysis of clinical growth in nursing education produced defining attributes, antecedents, and consequences. Attributes included higher-level thinking, socialization, skill development, self-reflection, self-investment, interpersonal communication, and linking theory to practice. Identification of critical attributes allows educators to adapt to student-centered learning in the clinical environment. These findings allow educators to determine significant research questions, develop situation-specific theories, and identify strategies to enhance student learning in the clinical environment.
Nursing educators and preceptors often find it difficult to evaluate prelicensure students' clinical judgment development. Clinical judgment is critical to excellent patient care decisions and outcomes. The Lasater Clinical Judgment Rubric, a validated, evidence-based clinical judgment rubric, is described as a tool that offers a common language for students, nurse educators, and preceptors and a trajectory for students' clinical judgment development. The rubric has been used to provide feedback for reflective journals and a means for self-evaluation in addition to a guide for formulating higher level thought questions to shape students' thinking like a nurse.
DeLaney, Thomas F
The clinical advantage for proton radiotherapy over photon approaches is the marked reduction in integral dose to the patient, due to the absence of exit dose beyond the proton Bragg peak. The integral dose with protons is approximately 60% lower than that with any external beam photon technique. Pediatric patients, because of their developing normal tissues and anticipated length of remaining life, are likely to have the maximum clinical gain with the use of protons. Proton therapy may also allow treatment of some adult tumors to much more effective doses, because of normal tissue sparing distal to the tumor. Currently, the most commonly available proton treatment technology uses 3D conformal approaches based on (a) distal range modulation, (b) passive scattering of the proton beam in its x- and y-axes, and (c) lateral beam-shaping. It is anticipated that magnetic pencil beam scanning will become the dominant mode of proton delivery in the future, which will lower neutron scatter associated with passively scattered beam lines, reduce the need for expensive beam-shaping devices, and allow intensity-modulated proton radiotherapy. Proton treatment plans are more sensitive to variations in tumor size and normal tissue changes over the course of treatment than photon plans, and it is expected that adaptive radiation therapy will be increasingly important for proton therapy as well. While impressive treatment results have been reported with protons, their cost is higher than for photon IMRT. Hence, protons should ideally be employed for anatomic sites and tumors not well treated with photons. While protons appear cost-effective for pediatric tumors, their cost-effectiveness for treatment of some adult tumors, such as prostate cancer, is uncertain. Comparative studies have been proposed or are in progress to more rigorously assess their value for a variety of sites. The utility of proton therapy will be enhanced by technological developments that reduce its cost
Park, Eun-Jun; Park, Seungmi; Jang, In-Sun
This study examines the extent and predictors of unethical clinical behaviors among nursing students in South Korea. From survey data of 345 undergraduate nursing students, unethical clinical behaviors were examined with respect to 11 individual characteristics, frequency and perceived seriousness of classroom cheating, two factors of individual attitude, and four contextual factors. Qualitative data from two focus group interviews were analyzed to explore reasons for and contexts of unethical clinical behaviors. About sixty-six percent of the participants engaged in one or more unethical clinical behaviors over a one-semester period. The prevalence of such behaviors varied widely from 1.7% to 40.9% and was related to the type of nursing program, the number of clinical practicum semesters completed, ethical attitudes toward cheating behaviors, the frequency of cheating on assignments, the frequency of cheating on exams, the perceived prevalence of cheating by peers, and prior knowledge of academic integrity. According to the regression analysis, the last four variables explained 29.4% of the variance in the prevalence of unethical clinical behaviors. In addition, multiple reasons and possible interventions for clinical misconduct were reported during the focus group interviews. Unlike cheating in the classroom, clinical misconduct was strongly induced by clinical nurses and poor clinical practice environments. In sum, unethical clinical behaviors were widespread among the participants and need to be corrected.
Kienle, Gunver S; Kiene, Helmut
Objectives Clinical judgment is a central element of the medical profession, essential for the performance of the doctor, and potentially generating information also for other clinicians and for scientists and health care managers. The recently renewed interest in clinical judgement is primarily engaged with its role in communication, diagnosis and decision making. Beyond this issue, the present article highlights the interrelations between clinical judgement, therapy assessment and medical professionalism. Methods Literature review and theory development. Results The article presents different methodological approaches to causality assessment in clinical studies and in clinical judgement, and offers criteria for clinical single case causality. The article outlines models of medical professionalism such as technical rationality and practice epistemology, and characterizes features of professional expertise such as tacit knowledge, reflection in action, and gestalt cognition. Conclusions Consequences of a methodological and logistical advancement of clinical judgment are discussed, both in regard to medical progress and to the renewel of the cognitive basis of the medical profession. PMID:20973873
Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.
The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials. PMID:23272300
Yu, Chunjiang; Shen, Bairong
The development of information technology has resulted in its penetration into every area of clinical research. Various clinical systems have been developed, which produce increasing volumes of clinical data. However, saving, exchanging, querying, and exploiting these data are challenging issues. The development of Extensible Markup Language (XML) has allowed the generation of flexible information formats to facilitate the electronic sharing of structured data via networks, and it has been used widely for clinical data processing. In particular, XML is very useful in the fields of data standardization, data exchange, and data integration. Moreover, ontologies have been attracting increased attention in various clinical fields in recent years. An ontology is the basic level of a knowledge representation scheme, and various ontology repositories have been developed, such as Gene Ontology and BioPortal. The creation of these standardized repositories greatly facilitates clinical research in related fields. In this chapter, we discuss the basic concepts of XML and ontologies, as well as their clinical applications.
Zhou, Qunyi; Guo, Wei; Lu, Xudong; Duan, Huilong
The digital clinical guidelines could greatly improve the safety and quality of clinical diagnosis and treatment. However, most of such guidelines were written in engineering language, which was difficult for clinicians to understand in practice. To tackle this problem, we adoped the flowchart as the visual representation method of digital clinical guidelines. The corresponding criterions expressed by the flowchart were easily understood by clinicians. Then we set the digital clinical guidelines written in Arden syntax as an example, the interconversion between flowcharts and digital clinical guidelines was realized. The result of using the visual representation method proposed in this paper shows that the clinical diagnosis logic becomes clear and intuitive. So this is an effective method for clinicians to understand and edit the digital clinical guidelines.
...: A Video Game About Clinical Trials SUMMARY: In compliance with the requirement of Section 3506(c)(2... Collection: Title: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information Collection... video game'' for adolescents about clinical studies which: (1) Incorporates core learning...
Voduc, David; Kenney, Challayne; Nielsen, Torsten O.
The tissue microarray is a recently-implemented, high-throughput technology for the analysis of molecular markers in oncology. This research tool permits the rapid assessment of a biomarker in thousands of tumor samples, using commonly available laboratory assays such as immunohistochemistry and in-situ hybridization. Although introduced less than a decade ago, the TMA has proven to be invaluable in the study of tumor biology, the development of diagnostic tests, and the investigation of oncological biomarkers. This review describes the impact of TMA-based research in clinical oncology and its potential future applications. Technical aspects of TMA construction, and the advantages and disadvantages inherent to this technology are also discussed. PMID:18314063
Quarracino, María; Aguas, Silvia
Lingual thyroid is an abnormal formation appearing as the result of a deficient descent during embryological development of the thyroid gland through the thyroglossal duct to its normal pretracheal location. The lesion consists of a tumor mass of thyroid tissue located at the base of the tongue, in the region of the foramen caecum linguae. The size can vary from a few millimeters to several centimeters in diameter. More than 400 cases of lingual thyroid have been documented in the literature to date. Lingual thyroid has been identified in 10% of the tongues examined in some autopsy series. Its identification is of great significance, since it may constitute the only functional thyroid tissue in the body, and may inadvertently be destroyed as a result of histological biopsy procedures. The present study presents a clinical case of lingual thyroid in a 17-year-old female.
Shah, Mohammad Taufik Bin Mohamed; Wong, Bak Siew Steven
A 30-year-old woman presented with a six-month history of left posterior heel pain. Physical examination revealed a tender, inflamed and indurated posterior heel with a visible bony prominence of the posterosuperior aspect of the calcaneus. Lateral ankle radiography showed a prominent left posterosuperior calcaneal tuberosity and thickening of the distal Achilles tendon outline. Magnetic resonance imaging demonstrated high-signal inflammatory fluid in the retrocalcaneal bursa, increased signal intensity and thickening of the Achilles tendon, and prominence of the posterior calcaneus tuberosity with reactive marrow oedema. The findings are consistent with Haglund’s deformity. The patient underwent hind foot surgery after failing a six-month course of conservative therapy. There was no further recurrence of symptoms after surgery. The clinical and radiological features of Haglund’s deformity are described, including a short discussion of other causes of hind foot pain. PMID:27663032
Sgroi, Antonino; Baertschiger, Reto M; Morel, Philippe; Buhler, Leo H
Organ transplantation has encountered great development during the 80's. However, the number of organ donations and transplantations performed stabilized during the 90ies, with a concomitant increase of patients on the waiting list. Xenotransplantation, i.e. the use of animal organs for transplantation to humans, is one among various alternatives to human organ donation. Xenotransplantation offers several advantages, e.g. it would be possible to transplant all patients at an early stage of their disease. The main barriers to xenotransplantation are the strong immunological responses that human develop against animal antigens and zoonoses. To overcome these hurdles, genetically modified pigs have been engineered by cloning and could allow the initiation of new clinical trials in a near future.
Ooi, Su Kai Gideon; Tan, Tien Jin; Ngu, James Chi Yong
A 46-year-old Chinese woman with a history of cholecystectomy and appendicectomy presented to the emergency department with symptoms of intestinal obstruction. Physical examination revealed central abdominal tenderness but no clinical features of peritonism. Plain radiography of the abdomen revealed a grossly distended large bowel loop with the long axis extending from the right lower abdomen toward the epigastrium, and an intraluminal air-fluid level. These findings were suspicious for an acute caecal volvulus, which was confirmed on subsequent contrast-enhanced computed tomography (CT) of the abdomen and pelvis. CT demonstrated an abnormal positional relationship between the superior mesenteric vein and artery, indicative of an underlying intestinal malrotation. This case highlights the utility of preoperative imaging in establishing the diagnosis of an uncommon cause of bowel obstruction. It also shows the importance of recognising the characteristic imaging features early, so as to ensure appropriate and expedient management, thus reducing patient morbidity arising from complications. PMID:27872936
Before any clinical trial begins, a detailed trial protocol must be prepared. The authority of the trial results will depend on the quality of this document. In many protocols, a key component is a plan for a series of interim analyses of the accumulating trial data, and a 'stopping rule' based on them. Such a rule might be intended to prevent participants from continuing to receive a drug that already seems to be unsafe, or to allow a successful drug to become generally available as soon as sufficient evidence of its advantages has been collected. There has been considerable misunderstanding of these rules, and controversies associated with them. Here, I discuss why this might be, and what can be done to promote their successful and beneficial use in the future.
To improve the equality of life, we must prevent the falls in both healthy elderly and patients with the cerebrovascular diseases. Wearable accelerometer was applied to monitor. In this paper, we introduced two different clinical applications. On is fall detector and the other is monitoring device for screening test. 1) We have developed body-worn accelerometer with data loggers and monitored the daily of life in patient with Parkinson disease. The patients wore the device and monitored falls while walking and standing. As a result, we could obtain fall times for a long period. 2) The ability of walking and standing have been evaluated by Timed up & go test. We used telemetry with accelerometer. The stability of walking could be evaluated by the acceleration signals. The simple body-won device can be useful for fall study.
Aller, T A
Myopia has been increasing in prevalence throughout the world, reaching over 90% in some East Asian populations. There is increasing evidence that whereas genetics clearly have an important role, the type of visual environment to which one is exposed to likely influences the onset, progression, and cessation of myopia. Consequently, attempts to either modify the environment or to reduce the exposure of the eye to various environmental stimuli to eye growth through the use of various optical devices are well under way at research centers around the globe. The most promising of current treatments include low-percentage atropine, bifocal soft contact lenses, orthokeratology, and multifocal spectacles. These methods are discussed briefly and are then categorized in terms of their expected degree of myopia progression control. A clinical strategy is presented for selecting the most effective treatment for the appropriate type of patient at the optimal stage of refractive development to achieve the maximum control of myopia progression. PMID:24357844
Hankard, R; Colomb, V; Piloquet, H; Bocquet, A; Bresson, J-L; Briend, A; Chouraqui, J-P; Darmaun, D; Dupont, C; Frelut, M-L; Girardet, J-P; Goulet, O; Rieu, D; Simeoni, U; Turck, D; Vidailhet, M
Protein energy malnutrition (PEM) occurs when energy and protein intake do not meet requirements. It has a functional and structural impact and increases both morbidity and mortality of a given disease. The Nutrition Committee of the French Pediatric Society recommends weighing and measuring any child when hospitalized or seen in consultation. The body mass index (BMI) must be calculated and analyzed according to references any time growth kinetics cannot be analyzed. Any child with a BMI below the third centile or -2 standard deviations for age and sex needs to be examined looking for clinical signs of malnutrition and signs orienting toward an etiology and requires having his BMI and height dynamics plotted on a chart. PEM warrants drawing up a nutritional strategy along with the overall care plan. A target weight needs to be determined as well as the quantitative and qualitative nutritional care including its implementation. This plan must be evaluated afterwards in order to adapt the nutritional therapy.
Sulmasy, Daniel P
Interest in the relationship between spirituality, religion, and clinical care has increased in the last 15 years, but clinicians need more concrete guidance about this topic. This article defines spirituality and religion, identifies the fundamental spiritual issues that serious illness raises for patients, and argues that physicians have a moral obligation to address patients' spiritual concerns. Religions often provide patients with specific moral guidance about a variety of medical issues and prescribe rituals that are important to patients. Religious coping can be both positive and negative, and it can impact patient care. This article provides concrete advice about taking a spiritual history, ethical boundaries, whether to pray with patients, and when to refer patients to chaplains or to their own personal clergy.
de Oliveira, Reinaldo Ayer; Jorge Filho, Isac
To think about ethics means to go into the Bioethics universe. If it is understood that medical ethics deals with doctors within an organized society under legal purposes, consensus and ethics in the exercise of medicine it is observed that Bioethics came up due to the need to debate and decide on the ethic questions related mainly to research and scientific advances as well as conquests concerning human rights and social-cultural development: it is the critical expression of our interest in conveniently using the development of medical art and science. Within Medicine, clinical Bioethics arouse as a possibility of thinking and discussing the practice of medicine in the different social institutions which deal with health and with professionals in health area.
A 6-month clinical trial in the Philippines sought to determine the efficacy of coconut oil and of "monolaurin," a coconut oil byproduct, in killing HIV by breaking down its coating. This research is based on the theory that medium-chain fatty acids, like monolaurin, can have this effect on certain viruses. The trial involves 12 women and 3 men in the early stage of HIV infection. 10 patients will take different doses of monolaurin, and 5 will consume coconut oil. It is hypothesized that the regimen will lead to higher CD4 counts and a lower viral load. The trial was almost abandoned because it received only lukewarm approval from the Health Secretary.
Moreno-Muñoz, Antonio; González, Juan J
This paper presents preliminary results from a power quality audit conducted at a clinical building over the last year. Voltage and current were measured at various laboratories; it was found that the main problems for the equipment installed were voltage sags and surges. The paper examines the causes and effects of power disturbances that affect computer or any other microprocessor-based equipment and analyzes the auto-protection capabilities of modern power supplies. The convenience of "enhanced power supply" or "low-cost customer-side" protection solutions is also discussed. Finally it is addresses the role of the Standards on the protection of electronic equipment and the implications for the final costumer.
Kalman, Thomas P
Abstract Pornography, if understood to involve the depiction of sexual activity, organs, and experiences, is perhaps as old as human civilization itself. Historically linked to various technological innovations, pornography viewing in the Internet age has reached epic proportions, with large numbers of individuals taking advantage of ease of access, affordability, and presumed anonymity to explore sexual material online. Within the mental health professions substantial research exists on the effects of viewing general pornography; however, the distinctive effects of the marriage of pornography and cyberspace is only beginning to be examined. In addition to reviewing some historical and statistical material about pornography and the relevant psychiatric and psychoanalytic literature, four detailed clinical vignettes are presented to illustrate the types of problems related to Internet pornography use that are being presented to practicing psychotherapists.
Our knowledge of the natural history of VIH infection has considerably increased during the last years. We know now that clinical evolution will depend of host factors as well as of viral characteristics. Among the host factors, the early specific cytotoxic response to VIH components plays a major role. Phenotypic variation of the virus (syncytium inducer mutants) and viral load in the lymph node and in the circulating CD4 cells play also an important role. As far as antiviral therapeutic is concerned, at the moment we know that monotherapy with nucleosides analogues is probably of limited efficacy because of emergence of resistance. Future perspectives include combination of antivirals aimed to prevent emergence of resistance and to reduce toxicity.
Novel high-throughput sequencing technologies generate large-scale genomic data and are used extensively for disease mapping of monogenic and/or complex disorders, personalized treatment, and pharmacogenomics. Next-generation sequencing is rapidly becoming routine tool for diagnosis and molecular monitoring of patients to evaluate therapeutic efficiency. The next-generation sequencing platforms generate huge amounts of genetic variation data and it remains a challenge to interpret the variations that are identified. Such data interpretation needs close collaboration among bioinformaticians, clinicians, and geneticists. There are several problems that must be addressed, such as the generation of new algorithms for mapping and annotation, harmonization of the terminology, correct use of nomenclature, reference genomes for different populations, rare disease variant databases, and clinical reports. PMID:27507302