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Sample records for current clinical standard

  1. Standards for scalable clinical decision support: need, current and emerging standards, gaps, and proposal for progress.

    Science.gov (United States)

    Kawamoto, Kensaku; Del Fiol, Guilherme; Lobach, David F; Jenders, Robert A

    2010-01-01

    Despite their potential to significantly improve health care, advanced clinical decision support (CDS) capabilities are not widely available in the clinical setting. An important reason for this limited availability of CDS capabilities is the application-specific and institution-specific nature of most current CDS implementations. Thus, a critical need for enabling CDS capabilities on a much larger scale is the development and adoption of standards that enable current and emerging CDS resources to be more effectively leveraged across multiple applications and care settings. Standards required for such effective scaling of CDS include (i) standard terminologies and information models to represent and communicate about health care data; (ii) standard approaches to representing clinical knowledge in both human-readable and machine-executable formats; and (iii) standard approaches for leveraging these knowledge resources to provide CDS capabilities across various applications and care settings. A number of standards do exist or are under development to meet these needs. However, many gaps and challenges remain, including the excessive complexity of many standards; the limited availability of easily accessible knowledge resources implemented using standard approaches; and the lack of tooling and other practical resources to enable the efficient adoption of existing standards. Thus, the future development and widespread adoption of current CDS standards will depend critically on the availability of tooling, knowledge bases, and other resources that make the adoption of CDS standards not only the right approach to take, but the cost-effective path to follow given the alternative of using a traditional, ad hoc approach to implementing CDS.

  2. Data standards for clinical research data collection forms: current status and challenges.

    Science.gov (United States)

    Richesson, Rachel L; Nadkarni, Prakash

    2011-05-01

    Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.

  3. Training in clinical forensic medicine in the UK--perceptions of current regulatory standards.

    Science.gov (United States)

    Stark, Margaret M; Norfolk, Guy A

    2011-08-01

    As clinical forensic medicine (CFM) is not currently recognised as a speciality in the UK there are no nationally agreed mandatory standards for training forensic physicians in either general forensic (GFM) or sexual offence medicine (SOM). The General Medical Council (GMC), the medical regulator in the UK, has issued clear standards for training in all specialities recommending that "trainees must be supported to acquire the necessary skills and experience through induction, effective educational supervision, an appropriate workload and time to learn". In order to evaluate the current situation in the field of clinical forensic medicine, doctors who have recently (within the last two years) started working in the field "trainees" (n = 38), and trainers (n = 61) with responsibility for clinical and educational supervision of new trainees, were surveyed by questionnaire to gather their perceptions of how the relevant GMC standards are being met in initial on-the-job training. Telephone interviews were performed with eleven doctors working as clinical or medical directors to determine their views. It is clear that currently the quality of training in CFM is sub-standard and inconsistent and that the published standards, as to the minimum requirement for training that must be met by post-graduate medical and training providers at all levels, are not being met. The Faculty of Forensic and Legal Medicine (FFLM) needs to set explicit minimum standards which will comply with the regulator and work to pilot credentialing for forensic physicians. A number of recommendations are made for urgent FFLM development.

  4. Clinical compliance of viewing conditions in radiology reporting environments against current guidelines and standards

    Science.gov (United States)

    Daly, S.; Rainford, L.; Butler, M. L.

    2014-03-01

    Several studies have demonstrated the importance of environmental conditions in the radiology reporting environment, with many indicating that incorrect parameters could lead to error and misinterpretation. Literature is available with recommendations as to the levels that should be achieved in clinical practice, but evidence of adherence to these guidelines in radiology reporting environments is absent. This study audited the reporting environments of four teleradiologist and eight hospital based radiology reporting areas. This audit aimed to quantify adherence to guidelines and identify differences in the locations with respect to layout and design, monitor distance and angle as well as the ambient factors of the reporting environments. In line with international recommendations, an audit tool was designed to enquire in relation to the layout and design of reporting environments, monitor angle and distances used by radiologists when reporting, as well as the ambient factors such as noise, light and temperature. The review of conditions were carried out by the same independent auditor for consistency. The results obtained were compared against international standards and current research. Each radiology environment was given an overall compliance score to establish whether or not their environments were in line with recommended guidelines. Poor compliance to international recommendations and standards among radiology reporting environments was identified. Teleradiology reporting environments demonstrated greater compliance than hospital environments. The findings of this study identified a need for greater awareness of environmental and perceptual issues in the clinical setting. Further work involving a larger number of clinical centres is recommended.

  5. [Current neurophysiological tests and revised JSCN technical standards for clinical EEG].

    Science.gov (United States)

    Ishiyama, Yoji

    2003-06-01

    The purpose of this lecture is to review the development of current neurophysiology and the revised standard of society for clinical EEG. 1. The improvement of neurophysiological tests. 1) EEG and evoked potential: EEG and evoked potential testing includes the routine EEG recording, EEG monitoring in surgical operation, all night sleep polygraph for the diagnosis of sleep apnea syndrome and many kinds of brain evoked potentials. Especially, the P300 component in the ERP(event-related evoked potential) is useful for the testing of essential brain functions. 2) EMG and evoked EMG: These tests are applied for the diagnosis of neurogenic, myogenic and neuromuscular junction disorder, and also the single fiber EMG using micro needle electrode is useful for the diagnosis of myasthenia gravis. Motor and sensory nerve conduction velocity are calculated from the latency of evoked EMGs. Furthermore, the distribution of these conduction velocities in many nerve fibers is measured by the collision technique. 3) Other tests: Near-infrared spectroscopy for the testing of brain functions has made rapid progress, and the transcranial magnetic stimulation method has come to be used for evaluation of functional diseases in the pyramidal tract, cerebellum and the spinal cord. 2. The revised JSCN technical standards for clinical EEG. The revised recording conditions of ECI(electro cerebral inactivity: flat EEG) in brain death are the focus of this lecture.

  6. Current status of nuclear cardiology in Japan: Ongoing efforts to improve clinical standards and to establish evidence.

    Science.gov (United States)

    Yoshinaga, Keiichiro; Tamaki, Nagara

    2015-08-01

    Nuclear cardiology imaging tests are widely performed in Japan as clinical practice. The Japanese nuclear cardiology community has developed new diagnostic imaging tests using (123)I-beta-methyl-p-iodophenyl-pentadecanoic acid, (123)I-metaiodobenzylguanidine, and (18)F-fluorodeoxyglucose PET for detecting cardiac involvement in sarcoidosis. These tests have become popular worldwide. The Japanese Circulation Society and the Japanese Society of Nuclear Cardiology have published clinical imaging guidelines showing indications and standards for the new imaging tests. JSNC is currently striving to improve the standard of clinical practice and is promoting research activities.

  7. Measuring against clinical standards.

    Science.gov (United States)

    Shaw, Charles D

    2003-07-15

    Systematic improvement of health services requires the objective measurement of people, practices and organisations against valid and explicit standards in order to identify and implement appropriate change. Effective quality systems must embrace a wide range of definitions of quality, and a similar variety of approaches to defining, measuring and improving. Clinical performance may be examined from three professional viewpoints--clinical competence: assessment of individual practitioners against explicit criteria to recognise achievement and to promote continuing development. Traditional mechanisms of training, registration and accreditation enable clinicians to reach career grades but responsibility for subsequent support is often unclear between employers, professions and registering bodies. Clinical practice: assessment of actual clinical process and outcomes against research-based "best practice" to identify and reduce variation. Peer review, clinical audit and confidential enquiries are examples of this approach, which may involve single or multiple professional groups and their interface with management. Service accreditation: systems to assess health care organisations against published standards in order to encourage best management practice. These are usually run on a regional or national basis and, though sensitive to expectations of patients, managers, clinicians, paying agencies and government, they are usually managed by an impartial but authoritative organisation.

  8. Enteroclysis: Current clinical value

    Science.gov (United States)

    Maataoui, Adel; Vogl, Thomas J; Jacobi, Volkmar; Khan, M Fawad

    2013-01-01

    AIM: To retrospectively analyze changes in clinical indication, referring medical specialty and detected pathology for small bowel double-contrast examinations. METHODS: Two hundred and forty-one (n = 143 females; n = 98 males; 01.01.1990-31.12.1990) and 384 (n = 225 females; n = 159 males; 01.01.2004-31.12.2010) patients underwent enteroclysis, respectively. All examinations were performed in standardized double-contrast technique. After placement of a nasojejunal probe distal to the ligament of Treitz, radiopaque contrast media followed by X-ray negative distending contrast media were administered. Following this standardized projections in all four abdominal quadrants were acquired. Depending on the detected pathology further documentation was carried out by focused imaging. Examination protocols were reviewed and compared concerning requesting unit, indication and final report. RESULTS: Two hundred and forty-one examinations in 1990 faced an average of 55 examinations per year from 2004-2010. There was an increase of examinations for gastroenterological (33.6% to 64.6%) and pediatric (0.4% to 7.8%) indications while internal (29.0% to 6.0% for inpatients and from 16.6% to 9.1% for outpatients) and surgical (12.4% to 7.3%) referrals significantly decreased. “Follow-up of Crohn’s disease” (33.1%) and “bleeding/tumor search” (15.1%) represented the most frequent clinical indications. A total of 34% (1990) and 53.4% (2004-2010) examinations yielded pathologic findings. In the period 01.01.2004 -31.12.2010 the largest proportion of pathological findings was found in patients with diagnosed Crohn’s disease (73.5%), followed by patients with abdominal pain (67.6% with history of surgery and 52.6% without history of surgery), chronic diarrhea (41.7%), suspected Crohn’s disease (39.5%) and search for gastrointestinal bleeding source/tumor (19.1%). The most common pathologies diagnosed by enteroclysis were “changes in Crohn’s disease” (25.0%) and

  9. Guidelines for the Design and Conduct of Clinical Studies in Knee Articular Cartilage Repair: International Cartilage Repair Society Recommendations Based on Current Scientific Evidence and Standards of Clinical Care.

    Science.gov (United States)

    Mithoefer, Kai; Saris, Daniel B F; Farr, Jack; Kon, Elizaveta; Zaslav, Kenneth; Cole, Brian J; Ranstam, Jonas; Yao, Jian; Shive, Matthew; Levine, David; Dalemans, Wilfried; Brittberg, Mats

    2011-04-01

    To summarize current clinical research practice and develop methodological standards for objective scientific evaluation of knee cartilage repair procedures and products. A comprehensive literature review was performed of high-level original studies providing information relevant for the design of clinical studies on articular cartilage repair in the knee. Analysis of cartilage repair publications and synopses of ongoing trials were used to identify important criteria for the design, reporting, and interpretation of studies in this field. Current literature reflects the methodological limitations of the scientific evidence available for articular cartilage repair. However, clinical trial databases of ongoing trials document a trend suggesting improved study designs and clinical evaluation methodology. Based on the current scientific information and standards of clinical care, detailed methodological recommendations were developed for the statistical study design, patient recruitment, control group considerations, study endpoint definition, documentation of results, use of validated patient-reported outcome instruments, and inclusion and exclusion criteria for the design and conduct of scientifically sound cartilage repair study protocols. A consensus statement among the International Cartilage Repair Society (ICRS) and contributing authors experienced in clinical trial design and implementation was achieved. High-quality clinical research methodology is critical for the optimal evaluation of current and new cartilage repair technologies. In addition to generally applicable principles for orthopedic study design, specific criteria and considerations apply to cartilage repair studies. Systematic application of these criteria and considerations can facilitate study designs that are scientifically rigorous, ethical, practical, and appropriate for the question(s) being addressed in any given cartilage repair research project.

  10. Evaluation standards for clinical coder training.

    Science.gov (United States)

    Bramley, Michelle; Reid, Beth

    2007-01-01

    This paper reports on an evaluation of clinical coder training programs, recently carried out in Ireland. In building an evaluation framework, the literature was reviewed to identify best practice standards, current practice, and professional opinion against which a sound judgment could be made. The literature was variable but nevertheless useful for the identification of evaluation standards. These standards are reproduced here in order to add to the literature. We also discuss the areas that would benefit from further research, thus contributing to the discourse on best practice in evaluating clinical coder training programs.

  11. Standardization of calibration of clinic dosemeters using electric currents and charges; Padronizacao da calibracao de dosimetros clinicos utilizando cargas e correntes eletricas

    Energy Technology Data Exchange (ETDEWEB)

    Peres, Marcos Antonio de Lima

    1999-09-15

    Clinical dosimeters used in radiotherapy are calibrated in Latin American countries, including Brazil, as a complete 'system, i.e., ionization chamber and electrometer together. Some countries, as European ones, and USA calibrate them by component, i.e., ionisation chamber apart from electrometer. This method is more advantageous than the previous one, since it makes possible the automation of the calibration process, allowing the acquisition of data related to the chamber and the electrometer measurements independently, as well as the substitution of one of the components, in case of failure. This work proposes a method for standardisation of low intensity electric charge and currents in order to implement electric calibration of electrometers. This will make possible the implementation of a by components calibration technique, by components, of clinical dosimeters in Brazil. The results obtained with the calibration by components prove that the proposed method of standardisation of low electric charges and currents is viable. The difficulties found for the generation and measurement of low intensity electric charges and currents and the procedures adopted for the calibration by components are presented. Additionally, a current source was built to yield reference electric charges that will make possible the quality control clinical dosimeters. This source will also allow the user to identify the defective components of the dosimeters, through a simple verification test. (author)

  12. Current clinical approach to achalasia

    Institute of Scientific and Technical Information of China (English)

    Alexander J Eckardt; Volker F Eckardt

    2009-01-01

    Idiopathic achalasia is a rare primary motility disorder of the esophagus.The classical features are incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and a lack of peristalsis in the tubular esophagus.These motor abnormalities lead to dysphagia,stasis,regurgitation,weight loss,or secondary respiratory complications.Although major strides have been made in understanding the pathogenesis of this rare disorder,including a probable autoimmune mediated destruction of inhibitory neurons in response to an unknown insult in genetically susceptible individuals,a definite trigger has not been identified.The diagnosis of achalasia is suggested by clinical features and confirmed by further diagnostic tests,such as esophagogastroduodenoscopy (EGD),manometry or barium swallow.These studies are not only used to exclude pseudoachalasia,but also might help to categorize the disease by severity or clinical subtype.Recent advances in diagnostic methods,including high resolution manometry (HRM),might allow prediction of treatment responses.The primary treatments for achieving long-term symptom relief are surgery and endoscopic methods.Although limited high-quality data exist,it appears that laparoscopic Heller myotomy with partial fundoplication is superior to endoscopic methods in achieving long-term relief of symptoms in the majority of patients.However,the current clinical approach to achalasia will depend not only on patients' characteristics and clinical subtypes of the disease,but also on local expertise and patient preferences.

  13. [Clinical pharmacology of current antiplatelet drugs].

    Science.gov (United States)

    Trenk, D; Nührenberg, T; Stratz, C; Valina, C M; Hochholzer, W

    2014-11-01

    Dual antiplatelet therapy with low-dose acetylsalicylic acid (ASA) and an inhibitor of the P2Y12 adenosine diphosphate (ADP) receptor is the standard treatment for patients presenting with acute coronary syndrome (ACS) or undergoing elective coronary interventions according to the current guidelines published by the European Society of Cardiology (ESC). New generation P2Y12 inhibitors, such as prasugrel and ticagrelor exert stronger and more consistent inhibition of the P2Y12 receptor. In clinical studies enrolling patients with ACS these drugs decreased the incidence of ischemic events compared to the standard therapy with clopidogrel and ASA; however, this beneficial effect was associated with an increase in bleeding events. Alternative therapeutic approaches via addition of drugs with different modes of action showed an overall reduction of ischemic events but also failed to uncouple this beneficial effect from an increased bleeding risk.

  14. Monocular Vision: Occupational Limitations and Current Standards

    Science.gov (United States)

    2011-03-01

    Kumagai, J. K., Williams, S., and Kline, D. (2005), Vision standards for aircrew: Visual acuity for pilots, (DRDC-TORONTO-CR-2005-142), Greenley ...Canadian Forces aircrew, (DRDC-TORONTO-CR-2006-255), Greenley and Associate Inc., Ottawa. Lövsund, P., Hedin, A., and Törnros, J. (1991), Effects...Williams, S., Casson, E., Brooks, J., Greenley , M., and Nadeau, J. (2003), Visual acuity standard for divers, Greenley & Associates Incorporated

  15. Standards for Clinical Grade Genomic Databases.

    Science.gov (United States)

    Yohe, Sophia L; Carter, Alexis B; Pfeifer, John D; Crawford, James M; Cushman-Vokoun, Allison; Caughron, Samuel; Leonard, Debra G B

    2015-11-01

    Next-generation sequencing performed in a clinical environment must meet clinical standards, which requires reproducibility of all aspects of the testing. Clinical-grade genomic databases (CGGDs) are required to classify a variant and to assist in the professional interpretation of clinical next-generation sequencing. Applying quality laboratory standards to the reference databases used for sequence-variant interpretation presents a new challenge for validation and curation. To define CGGD and the categories of information contained in CGGDs and to frame recommendations for the structure and use of these databases in clinical patient care. Members of the College of American Pathologists Personalized Health Care Committee reviewed the literature and existing state of genomic databases and developed a framework for guiding CGGD development in the future. Clinical-grade genomic databases may provide different types of information. This work group defined 3 layers of information in CGGDs: clinical genomic variant repositories, genomic medical data repositories, and genomic medicine evidence databases. The layers are differentiated by the types of genomic and medical information contained and the utility in assisting with clinical interpretation of genomic variants. Clinical-grade genomic databases must meet specific standards regarding submission, curation, and retrieval of data, as well as the maintenance of privacy and security. These organizing principles for CGGDs should serve as a foundation for future development of specific standards that support the use of such databases for patient care.

  16. Pharmacotherapy of erectile dysfunction: Current standards

    Directory of Open Access Journals (Sweden)

    Kew-Kim Chew

    2006-01-01

    Full Text Available Pharmacotherapy is currently the therapeutic option of choice for erectile dysfunction. Comprising mainly intracavernosal injection therapy using alprostadil or alprostadil combined with phentolamine and/or papaverine and oral phosphodiesterase-5 inhibitors, it is safe and effective if appropriately prescribed and administered. The medications in current use produce satisfactory erectile responses by enhancing cavernosal vasodilatation mainly through their ability to promote relaxation of the smooth muscle cells in the corpora cavernosa involving the synthesis and activity of nitric oxide via the cyclic guanosine monophosphate and cyclic adenosine monophosphate biochemical pathways. The main side-effects and complications of intracavernosal injections are postinjection pain, prolonged erections, priapism and penile fibrosis. There may be a variety of side-effects with phosphodiesterase-5 inhibition but these are usually inconsequential. Recent serious ill health and the need for ongoing long-acting nitrate therapy or frequent use of short-acting nitrates for angina are absolute contraindications to the use of phosphodiesterase-5 inhibitors. Caution has to be exercised in prescribing phosphodiesterase-5 inhibitors for patients with impaired renal or hepatic functions or receiving multi-drug therapy for any systemic disease. All patients presenting with erectile dysfunction should be investigated and treated for cardiovascular risk factors. They should also be counseled regarding lifestyle factors particularly healthy balanced diet, regular physical exercise and inappropriate social habits.

  17. Standard guidelines for electrosurgery with radiofrequency current

    Directory of Open Access Journals (Sweden)

    Mutalik Sharad

    2009-08-01

    Full Text Available Definition: Radiofrequency (RF induces thermal destruction of the targeted tissue by an electrical current at a frequency of 0.5 MHz (RF. As the electrode tip is not heated, there is minimal thermal damage to the surrounding tissues, producing good esthetic results. Therefore, RF ablation is also known as cold ablation or "coblation." Modality: It has three modes of operation: (a Cut, (b cut and coagulate and (c coagulate. Therefore, it can be used for various purposes like incision, ablation, fulguration, shave excision and coagulation. Because of the coagulation facility, hemostasis can be achieved and operation becomes easier and faster. Indications: It is effective in treating various skin conditions like dermatosis papulosa nigra, warts, molluscum contagiosum, colloid milia, acquired junctional, compound and dermal melanocytic nevi, seborrheic keratosis, skin tags, granuloma pyogenicum, verrucous epidermal nevi, xanthelesma, rhinophyma, superficial basal cell carcinoma and telangiectasia. It can also be used for cosmetic indications such as resurfacing, earlobe repair and blepharoplasty. Anesthesia: The procedure is accomplished either under topical anesthesia eutactic mixture of local anesthetics or local injectable anesthesia, under all aseptic precautions. Procedure: While operating, only the tip of the electrode should come in contact with the tissue. Actual contact of the electrode with the tissue should be very brief in order to prevent excessive damage to the deeper tissues. This can be accomplished by moving the electrode quickly. Complications: Complications are uncommon and mainly occur due to an improper technique. The treating physician should be aware of the contraindications of the procedure as listed in these guidelines. Physician qualification: RF surgery may be performed by a dermatologist who has acquired adequate training during post-graduation or through recognized fellowships and workshops dedicated to RF surgery. He

  18. Current Status and Future Prospects of Hydroelectricity Standardization

    Institute of Scientific and Technical Information of China (English)

    2010-01-01

    Technical standardization is very essential to electricity industry, which plays an active role in many aspects including technology standardization, secure and economic operation of power systems, environment protection, technological progress, and improvement of enterprises' management. This paper introduces the current status of hydroelectricity standardization, summarizes the progress and achievements, and then points out the development direction and working target in the future.

  19. Current Status and Future Prospects of Hydroelectricity Standardization

    Institute of Scientific and Technical Information of China (English)

    Liu Yongdong

    2010-01-01

    @@ Technical standardization is very essential to electricity industry, which plays an active role in many aspects including technology standardization, secure and economic operation of power systems, environment protection, technological progress, and improvement of enterprises' management. This paper introduces the current status of hydroelectricity standardization, summarizes the progress and achievements, and then points out the development direction and working target in the future.

  20. Standard operating procedures for clinical research departments.

    Science.gov (United States)

    Kee, Ashley Nichole

    2011-01-01

    A set of standard operating procedures (SOPs) provides a clinical research department with clear roles, responsibilities, and processes to ensure compliance, accuracy, and timeliness of data. SOPs also serve as a standardized training program for new employees. A practice may have an employee that can assist in the development of SOPs. There are also consultants that specialize in working with a practice to develop and write practice-specific SOPs. Making SOPs a priority will save a practice time and money in the long run and make the research practice more attractive to corporate study sponsors.

  1. Clobazam: uncontrolled and standard controlled clinical trials.

    Science.gov (United States)

    Ban, T A; Amin, M M

    1979-01-01

    1 In an uncontrolled clinical trial, carried out in 11 psychiatric patients with the clinical diagnoses of anxiety neurosis and depressive neurosis, clobazam, a new benzodiazepine preparation, in the dosage range 10-60 mg daily produced statistically significant improvement in the total and both factor scores of the Hamilton Anxiety Scale (HAM-A). The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 48 mg daily. 2 Results of the uncontrolled clinical trial were further substantiated in a standard-controlled clinical study in which no statistically significant difference between the therapeutic effectiveness of clobazam and diazepam could be revealed. The lowest mean total HAM-A scores occurred with a mean clobazam dosage of 49 mg daily. There was a lower incidence of adverse effects reported in patients receiving clobazam than in those taking the control drug (diazepam).

  2. Remote ischemic conditioning: Current clinical perspectives.

    Science.gov (United States)

    Le Page, Sophie; Prunier, Fabrice

    2015-08-01

    Remote ischemic conditioning (RIC) constitutes a promising method in which a tissue or organ is exposed to intermittent ischemia/reperfusion periods enabling it to provide protection to a distant target organ. RIC has been tested in various clinical settings through its simple application by means of intermittent inflation of a blood pressure cuff placed on a limb, primarily evaluating its potential abilities to decrease myocardial injury biomarkers. Its use on other organs, such as the kidneys or brain, has recently been a topic of research. To date, no study has yet been powerful enough to reach a conclusion on the potential benefit of RIC on clinical outcomes. The future role of RIC in the clinical arena could be clarified by the large phase III trials currently underway targeting major outcomes as primary endpoints.

  3. Continuous glucose monitoring: current clinical use.

    Science.gov (United States)

    Kim, Hun-Sung; Shin, Jeong-Ah; Chang, Jin-Sun; Cho, Jae-Hyoung; Son, Ho-Young; Yoon, Kun-Ho

    2012-12-01

    Four kinds of subcutaneous continuous glucose monitoring (CGM) machines have been currently introduced in clinical practice. These machines exhibit real-time glucose on the monitor every 5 minutes and have alarms to indicate hypoglycaemia and hyperglycaemia. However, thus far, there is no clear consensus about the clinical indications for CGM in actual clinical practice. CGM should be an ideal and powerful tool for monitoring glucose variability. Glycaemic variability has become a major concern over the years with growing evidence on its detrimental impact with respect to the risk of diabetic complications. Although the HbA1c level is ubiquitously measures in clinical practice, this level does not adequately represent glycaemic variability. Currently available evidence indicates that CGM aids in lowering the HbA1c level without increasing the incidence of severe hypoglycaemic episodes in patients with type 1 diabetes. Thus far, CGM has not been indicated for preventing severe hypoglycaemia or for treating type 2 diabetes because sufficient supporting evidence has not been obtained. Promising results have been obtained for the use of CGM for pregnant women with diabetes and for patients with hospital hyperglycaemia. Predictions regarding the feasibility of the closed-loop system have proven to be optimistic. CGM-integrated communication systems using information technology such as smart phone help controlling blood glucose more easily and effectively.

  4. The clinical application of clopidogrel in current coronary artery surgery

    Institute of Scientific and Technical Information of China (English)

    Yangyang Zhang; Kejiang Cao

    2008-01-01

    The article presents an overview of the current clinical application of clopidogrel in coronary artery surgery. The viewpoint is that clopidogrel can reduce preoperative and postoperative ischemic events of coronary artery bypass grafting(CABG). With the development of standardized medication and the corresponding preventive technique, it will be of great value to reduce hemorrhage complications and obtain the maximum benefit from clopidogrel' s anti-platelet properties.

  5. Current topics in clinical FES in Japan.

    Science.gov (United States)

    Handa, Y

    1997-12-01

    This paper reviews recent topics of clinical application of functional electrical stimulation (FES) for the paralyzed extremities in Japan. Transcutaneous and percutaneous FES systems have been clinically used in Japan. Candidates of extremity FES arer mostly stroke and spinal cord injury patients. By using percutaneous FES system, all of the joints of the upper extremity including the shoulder have been controlled for activities of daily living in the hemiplegic patient. Simultaneous FES control of the hand and wrist and the bilateral hands have also been achieved in C5 and C6 quadriplegics, respectively. Hybrid FES systems using percutaneous and surface electrodes, where FES is used in combination with orthoses, have been applied to the paraplegics because they are highly practical for assisting their locomotive activities. Percutaneous FES have been also provided the amyotropic lateral sclerosis patients with standing up motion. A total implant FES system with 16 output channels is currently developing as a next generation FES system.

  6. Current clinical management of brainstem cavernomas.

    Science.gov (United States)

    Bozinov, Oliver; Hatano, Taketo; Sarnthein, Johannes; Burkhardt, Jan-Karl; Bertalanffy, Helmut

    2010-11-26

    Over the last two decades a favourable course for treated or nontreated brainstem cavernomas has become possible with enhanced diagnostic tools and clinical experience, as well as minimally invasive microsurgical improvements. Currently, brainstem cavernoma can be treated microsurgically with excellent results and an acceptable morbidity rate. The preferred surgical route has progressively shifted from a dorsal to a lateral approach, but this remains dependent on the location of the lesion in the brainstem. Surgical evaluation and management of all cases of this rare disease should be performed by experienced teams from the outset.

  7. Current clinical evidence on pioglitazone pharmacogenomics

    Directory of Open Access Journals (Sweden)

    Marina eKawaguchi-Suzuki

    2013-11-01

    Full Text Available Pioglitazone is the most widely used thiazolidinedione and acts as an insulin-sensitizer through activation of the Peroxisome Proliferator-Activated Receptor-γ (PPARγ. Pioglitazone is approved for use in the management of type 2 diabetes mellitus, but its use in other therapeutic areas is increasing due to pleiotropic effects. In this hypothesis article, the current clinical evidence on pioglitazone pharmacogenomics is summarized and related to variability in pioglitazone response. How genetic variation in the human genome affects the pharmacokinetics and pharmacodynamics of pioglitazone was examined. For pharmacodynamic effects, hypoglycemic and anti-atherosclerotic effects, risks of fracture or edema, and the increase in body mass index in response to pioglitazone based on genotype were examined. The genes CYP2C8 and PPARG are the most extensively studied to date and selected polymorphisms contribute to respective variability in pioglitazone pharmacokinetics and pharmacodynamics. We hypothesized that genetic variation in pioglitazone pathway genes contributes meaningfully to the clinically observed variability in drug response. To test the hypothesis that genetic variation in PPARG associates with variability in pioglitazone response, we conducted a meta-analysis to synthesize the currently available data on the PPARG p.Pro12Ala polymorphism. The results showed that PPARG 12Ala carriers had a more favorable change in fasting blood glucose from baseline as compared to patients with the wild-type Pro12Pro genotype (p=0.018. Unfortunately, findings for many other genes lack replication in independent cohorts to confirm association; further studies are needed. Also, the biological functionality of these polymorphisms is unknown. Based on current evidence, we propose that pharmacogenomics may provide an important tool to individualize pioglitazone therapy and better optimize therapy in patients with T2DM or other conditions for which pioglitazone

  8. Framework for clinical data standardization based on archetypes.

    Science.gov (United States)

    Maldonado, Jose A; Moner, David; Tomás, Diego; Angulo, Carlos; Robles, Montserrat; Fernández, Jesualdo T

    2007-01-01

    Standardization of data is a prerequisite to achieve semantic interoperability in any domain. This is even more important in the healthcare sector where the need for exchanging health related data among professional and institutions is not an exception but the rule. Currently, there are several international organizations working on the definition of electronic health record architectures, some of them based on a dual-model approach. We present both an archetype modeling framework and LinkEHR-ED, an archetype editor and mapping tool for transforming existing electronic healthcare data which do not conform to a particular electronic healthcare record architecture into compliant electronic health records extracts. In particular, archetypes in LinkEHR-ED are formal representations of clinical concepts built on a particular reference model but enriched with mapping information to data sources which define how to extract and transform existing data in order to generate standardized XML documents.

  9. Data standards in clinical research: gaps, overlaps, challenges and future directions.

    Science.gov (United States)

    Richesson, Rachel L; Krischer, Jeffrey

    2007-01-01

    Current efforts to define and implement health data standards are driven by issues related to the quality, cost and continuity of care, patient safety concerns, and desires to speed clinical research findings to the bedside. The President's goal for national adoption of electronic medical records in the next decade, coupled with the current emphasis on translational research, underscore the urgent need for data standards in clinical research. This paper reviews the motivations and requirements for standardized clinical research data, and the current state of standards development and adoption--including gaps and overlaps--in relevant areas. Unresolved issues and informatics challenges related to the adoption of clinical research data and terminology standards are mentioned, as are the collaborations and activities the authors perceive as most likely to address them.

  10. Standards to Guide the Use of Clinical Judgment in the Field of Intellectual Disability.

    Science.gov (United States)

    Luckasson, Ruth; Schalock, Robert L

    2015-06-01

    The purpose of this article is to discuss 10 Clinical Judgment Standards and associated best practice indicators based on current literature and an understanding of the context of clinical judgment. Throughout the article, we stress the important role that clinical judgment plays in formulating valid and precise decisions and recommendations regarding diagnosis, classification, and planning supports.

  11. Current safety standards in infant nutrition--a European perspective.

    Science.gov (United States)

    Hernell, Olle

    2012-01-01

    Foods intended specifically for infants and young children are considered under European community law and are defined in specific commission directives. In principal, these directives conclude that such foods must be safe, have a special composition, be distinguishable from normal foods, be suitable for fulfilling particular nutritional requirements, and should, when marketed, indicate such suitability. Since infant formulas are intended as the sole source of nutrition during the first months of life, their nutritional adequacy and safety are particularly strictly regulated. The Scientific Committee on Food report from 2003, on which the current commission directive is based, makes clear recommendations on how benefits, suitability, and safety of modifications beyond established standards should be documented and evaluated. These principles resulted in part from a workshop on characterization of infant food modifications in the EU and two position papers by the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). These papers are reviewed below.

  12. 42 CFR 493.1276 - Standard: Clinical cytogenetics.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Standard: Clinical cytogenetics. 493.1276 Section 493.1276 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN... Testing Analytic Systems § 493.1276 Standard: Clinical cytogenetics. (a) The laboratory must have...

  13. Clinical utility of eslicarbazepine: current evidence

    Directory of Open Access Journals (Sweden)

    Zaccara G

    2015-02-01

    Full Text Available Gaetano Zaccara,1 Fabio Giovannelli,1,2 Massimo Cincotta,1 Alessia Carelli,3 Alberto Verrotti31Department of Medicine, Unit of Neurology, Florence Health Authority, Florence, Italy; 2Department of Neuroscience, Psychology, Pharmacology and Child Health (NEUROFARBA, University of Florence, Florence, Italy; 3Department of Pediatrics, University of Perugia, Perugia, ItalyAbstract: Eslicarbazepine acetate (ESL is a new antiepileptic drug whose mechanism of action is blockade of the voltage-gated sodium channel (VGSC. However, in respect to carbamazepine and oxcarbazepine, the active ESL metabolite (eslicarbazepine affects slow inactivation of VGSC and has a similar affinity for the inactivated state and a lower affinity for the resting state of the channel. This new antiepileptic drug has been recently approved in Europe (trade name Zebinix and in the United States (trade name Stedesa for adjunctive treatment in adult subjects with partial-onset seizures, with or without secondary generalization. Following oral administration, ESL is rapidly and extensively metabolized by hepatic esterases to eslicarbazepine. This active metabolite has a linear pharmacokinetic profile, a low binding to plasma proteins (<40%, and a half-life of 20–24 hours and is mainly excreted by kidneys in an unchanged form or as glucuronide conjugates. ESL is administered once a day and has a low potential for drug–drug interactions. Efficacy and safety of this drug in patients with focal seizures have been assessed in four randomized clinical trials, and responder rates (percentage of patients with a ≥50% improvement of their seizures ranged between 17% and 43%. Adverse events were usually mild to moderate, and the most common were dizziness, somnolence, diplopia, abnormal coordination, blurred vision, vertigo, headache, fatigue, nausea, and vomiting. ESL may be considered an interesting alternative to current antiepileptic drugs for the treatment of drug-resistant focal

  14. Practice standards for quality clinical decision-making in nursing.

    Science.gov (United States)

    Arries, E

    2006-03-01

    The purpose of this study is to formulate practice standards for quality clinical decision-making in nursing. Clinical decision-making is a critical component of nursing practice, as the life of the patient is at stake. The quality of clinical decision-making is, therefore, essential in delivering quality nursing care. The facilitation of quality clinical decision-making in nursing requires the development of standards to monitor, evaluate and implement remedial actions that improve on the quality of clinical decision-making (Muller, 2002:203; Beyea & Nicoll, 1999: 495). However, there are no such practice standards against which the quality of clinical decision-making by nurses can be evaluated and assessed. A qualitative, explorative, descriptive and standard formulation research design (Mouton & Marais, 1990:45-46; Muller, 1990:49-55) has been followed to develop standards for quality clinical decision-making in nursing. Standard development was based on the principles described by Muller (in Booyens, 1998: 607-608; 636-637), and consists of development and quantification phases that are modified to meet the requirements for instrument development, as described by Lynn (1986: 382-385). The formulation of these practice-standards was derived deductively from a conceptual framework. The conceptual framework was constructed based on an exploration and description of the expectations of the stakeholders about quality clinical decision-making in nursing and a literature study on clinical decision-making. To ensure the credibility of the standards for clinical decision-making in nursing, principles of logic, prolonged engagement, triangulation, peer-group discussion, dense description, step-wise repetition and an investigative audit (Lincoln & Guba, 1985:289-331) were adhered to. Two experts were consulted to validate the standards for quality clinical decision-making in nursing.

  15. Practice standards for quality clinical decision-making in nursing

    Directory of Open Access Journals (Sweden)

    E Arries

    2006-09-01

    Full Text Available The purpose of this study is to formulate practice standards for quality clinical decision making in nursing. Clinical decision-making is a critical component of nursing practice, as the life of the patient is at stake. The quality of clinical decision-making is, therefore, essential in delivering quality nursing care. The facilitation of quality clinical decision-making in nursing requires the development of standards to monitor, evaluate and implement remedial actions that improve on the quality of clinical decision-making (Muller, 2002:203; Beyea & Nicoll, 1999:495. However, there are no such practice standards against which the quality of clinical decision-making by nurses can be evaluated and assessed. A qualitative, explorative, descriptive and standard formulation research design (Mouton & Marais, 1990:45-46; Muller, 1990:49-55 has been followed to develop standards for quality clinical decision-making in nursing. Standard development was based on the principles described by Muller (in Booyens, 1998:607-608; 636-637, and consists of development and quantification phases that are modified to meet the requirements for instrument development, as described by Lynn (1986:382-385. The formulation of these practice-standards was derived deductively from a conceptual framework. The conceptual framework was constructed based on an exploration and description of the expectations of the stakeholders about quality clinical decisionmaking in nursing and a literature study on clinical decision-making. To ensure the credibility of the standards for clinical decision-making in nursing, principles of logic, prolonged engagement, triangulation, peer-group discussion, dense description, stepwise repetition and an investigative audit (Lincoln & Guba, 1985:289-331 were adhered to. Two experts were consulted to validate the standards for quality clinical decisionmaking in nursing.

  16. Pathology and sensitivity of current clinical criteria in corticobasal syndrome.

    Science.gov (United States)

    Ouchi, Haruka; Toyoshima, Yasuko; Tada, Mari; Oyake, Mutsuo; Aida, Izumi; Tomita, Itsuro; Satoh, Akira; Tsujihata, Mitsuhiro; Takahashi, Hitoshi; Nishizawa, Masatoyo; Shimohata, Takayoshi

    2014-02-01

    The aim of this study was to investigate corticobasal syndrome with respect to underlying pathologies, the ability of current clinical criteria to detect early stages of disease, and symptoms and signs predicting background pathologies. We retrospectively analyzed the clinicopathological findings from patients with corticobasal syndrome. We also analyzed whether those findings fulfilled the diagnostic criteria for corticobasal degeneration (CBD). Finally, we investigated characteristic clinical features that are specific to each background pathology. Of 10 consecutive autopsied patients who had corticobasal syndrome (mean age ± standard deviation, 67.9 ± 9.3 years; male:female ratio, 6:4), three had corticobasal degeneration pathology, three had progressive supranuclear palsy, three had Alzheimer's disease, and one had atypical four-repeat tauopathy. Nine patients fulfilled Mayo criteria, and all 10 patients fulfilled modified Cambridge criteria at the later stage, but only two patients fulfilled either clinical criteria within 2 years of disease onset. Five patients fulfilled the clinical criteria for possible CBD (p-CBD), and one patient fulfilled the clinical research criteria for probable sporadic CBD (cr-CBD) at the later stage. Only two patients fulfilled the criteria for either p-CBD or cr-CBD within 2 years of disease onset. Although we could not find any predictive characteristic clinical features that were specific to CBD pathology, only patients with progressive supranuclear palsy developed apraxia of eyelid opening and cerebellar ataxia. Myoclonus and memory impairment, especially if they appear at an early stage of the disease, may predict Alzheimer's disease pathology. Sensitivity of the available clinical criteria for corticobasal syndrome was poor within 2 years of disease onset.

  17. Open Augmented Reality Standards: Current Activities in Standards- Development Organizations%Open Augmented Reality Standards: Current Activities in Standards- Development Organizations

    Institute of Scientific and Technical Information of China (English)

    Christine Perey

    2012-01-01

    Augmented reality (AR) has emerged from research laboratories and is now being accepted in other domains as an attractive way of visualizing information. Before AR can be used in the mass market, there are a number of obstacles that need to be overcome. Several of these can be overcome by adopting open standards. A global grassroots community seeking open, interoperable AR content and experiences began to take shape in early 2010. This community is working collaboratively to reduce the barriers to the flow of data from content provider to AR end user. Standards development organizations and industry groups that provide open interfaces for AR meet regularly to provide updates, identify complementary work, and seek harmonization. The community also identifies deployer and implementer needs, communicates requirements, and discusses emerging challenges that could be resolved with standards. In this article, we describe current activities in international standards-development organizations. We summarize the AR standards gap analysis and shed light on special considerations for using standards in mobile AR.

  18. Clinical characteristics and current treatment of glaucoma.

    Science.gov (United States)

    Cohen, Laura P; Pasquale, Louis R

    2014-06-02

    Glaucoma is a neurodegenerative disorder in which degenerating retinal ganglion cells (RGC) produce significant visual disability. Clinically, glaucoma refers to an array of conditions associated with variably elevated intraocular pressure (IOP) that contributes to RGC loss via mechanical stress, vascular abnormalities, and other mechanisms, such as immune phenomena. The clinical diagnosis of glaucoma requires assessment of the ocular anterior segment with slit lamp biomicroscopy, which allows the clinician to recognize signs of conditions that can produce elevated IOP. After measurement of IOP, a specialized prismatic lens called a gonioscope is used to determine whether the angle is physically open or closed. The structural manifestation of RGC loss is optic nerve head atrophy and excavation of the neuroretinal rim tissue. Treatment is guided by addressing secondary causes for elevated IOP (such as inflammation, infection, and ischemia) whenever possible. Subsequently, a variety of medical, laser, and surgical options are used to achieve a target IOP.

  19. Current clinical research in orthodontics: a perspective.

    Science.gov (United States)

    Baumrind, Sheldon

    2006-10-01

    This essay explores briefly the approach of the Craniofacial Research Instrumentation Laboratory to the systematic and rigorous investigation of the usual outcome of orthodontic treatment in the practices of experienced clinicians. CRIL's goal is to produce a shareable electronic database of reliable, valid, and representative data on clinical practice as an aid in the production of an improved environment for truly evidence-based orthodontic treatment.

  20. Using clinical element models for pharmacogenomic study data standardization.

    Science.gov (United States)

    Zhu, Qian; Freimuth, Robert R; Pathak, Jyotishman; Chute, Christopher G

    2013-01-01

    Standardized representations for pharmacogenomics data are seldom used, which leads to data heterogeneity and hinders data reuse and integration. In this study, we attempted to represent data elements from the Pharmacogenomics Research Network (PGRN) that are related to four categories, patient, drug, disease and laboratory, in a standard way using Clinical Element Models (CEMs), which have been adopted in the Strategic Health IT Advanced Research Project, secondary use of EHR (SHARPn) as a library of common logical models that facilitate consistent data representation, interpretation, and exchange within and across heterogeneous sources and applications. This was accomplished by grouping PGRN data elements into categories based on UMLS semantic type, then mapping each to one or more CEM attributes using a web-based tool that was developed to support curation activities. This study demonstrates the successful application of SHARPn CEMs to the pharmacogenomic domain. It also identified several categories of data elements that are not currently supported by SHARPn CEMs, which represent opportunities for further development and collaboration.

  1. Standard practice for characterization of coatings using conformable Eddy-Current sensors without coating reference standards

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2011-01-01

    1.1 This practice covers the use of conformable eddy-current sensors for nondestructive characterization of coatings without standardization on coated reference parts. It includes the following: (1) thickness measurement of a conductive coating on a conductive substrate, (2) detection and characterization of local regions of increased porosity of a conductive coating, and (3) measurement of thickness for nonconductive coatings on a conductive substrate or on a conductive coating. This practice includes only nonmagnetic coatings on either magnetic (μ ≠ μ0) or nonmagnetic (μ = μ0) substrates. This practice can also be used to measure the effective thickness of a process-affected zone (for example, shot peened layer for aluminum alloys, alpha case for titanium alloys). For specific types of coated parts, the user may need a more specific procedure tailored to a specific application.

  2. [Schizophrenic disorders: current etiologic and clinical knowledge].

    Science.gov (United States)

    Olié, Jean-Pierre; Krebs, Marie-Odile; Lôo, Henri

    2005-05-01

    Brain anomalies associated with schizophrenic disorders may be of a cognitive, neurophysiological or neurological nature [the latter being relatively minor and nonspecific]. Brain imaging has revealed early anomalies such as cortical-subcortical atrophy and abnormal gyration. These anomalies can also be present in relatives free of schizophrenic symptoms. This raises the question of what determines the transition from vulnerability to clinical onset. There is now evidence that schizophrenic disorders are true brain diseases. This is based on neuropathological studies, brain imaging and clinical findings such as "soft" neurological signs (pyramidal and extrapyramidal symptoms, coordination difficulties, etc.). Cognitive dysfunctions such as attention and memory disorders and abnormal verbal fluency have also been described. Oculomotor pursuit and auditive evoked potentials have identified specific neurophysiological disorders such as N300 and P50 wave modifications. Schizophrenic disorders can also be associated with neuronal abnormalities, notably affecting factors involved in synaptic transmission and plasticity. For example, BDNF protein deficit is linked to certain late-onset forms of schizophrenia. Genetic studies are no longer focusing on a possible disease genotype but rather on phenotypic characteristics determined by simpler genotypes (P50 wave modulation, COMT and BDNF genes). The ultimate objective is to identify high-risk subjects, in order to shorten the treatment delay and thereby improve long-term outcome. The benefit of primary prophylaxis remains to be determined, however.

  3. Occlusion on oral implants: current clinical guidelines.

    Science.gov (United States)

    Koyano, K; Esaki, D

    2015-02-01

    Proper implant occlusion is essential for adequate oral function and the prevention of adverse consequences, such as implant overloading. Dental implants are thought to be more prone to occlusal overloading than natural teeth because of the loss of the periodontal ligament, which provides shock absorption and periodontal mechanoreceptors, which provide tactile sensitivity and proprioceptive motion feedback. Although many guidelines and theories on implant occlusion have been proposed, few have provided strong supportive evidence. Thus, we performed a narrative literature review to ascertain the influence of implant occlusion on the occurrence of complications of implant treatment and discuss the clinical considerations focused on the overloading factors at present. The search terms were 'dental implant', 'dental implantation', 'dental occlusion' and 'dental prosthesis'. The inclusion criteria were literature published in English up to September 2013. Randomised controlled trials (RCTs), prospective cohort studies and case-control studies with at least 20 cases and 12 months follow-up interval were included. Based on the selected literature, this review explores factors related to the implant prosthesis (cantilever, crown/implant ratio, premature contact, occlusal scheme, implant-abutment connection, splinting implants and tooth-implant connection) and other considerations, such as the number, diameter, length and angulation of implants. Over 700 abstracts were reviewed, from which more than 30 manuscripts were included. We found insufficient evidence to establish firm clinical guidelines for implant occlusion. To discuss the ideal occlusion for implants, further well-designed RCTs are required in the future.

  4. 21st Century Standards and Curriculum: Current Research and Practice

    Science.gov (United States)

    Alismail, Halah Ahmed; McGuire, Patrick

    2015-01-01

    The integration of Common Core State Standards (CCSS) and 21st century skills in the curriculum is not only beneficial to students and teachers, but also necessary to prepare our youth for their future careers. In an age of education where standardized tests determine the success of our schools, it is important to allow students the creativity and…

  5. Vaginitis: current microbiologic and clinical concepts.

    Science.gov (United States)

    Hill, L V; Embil, J A

    1986-01-01

    Infectious vaginitis occurs when the normal vaginal flora is disrupted; it may arise when saprophytes overwhelm the host immune response, when pathogenic organisms are introduced into the vagina or when changes in substrate allow an imbalance of microorganisms to develop. Examples of these types of vaginitis include the presence of chronic fungal infection in women with an inadequate cellular immune response to the yeast, the introduction of trichomonads into vaginal epithelium that has a sufficient supply of glycogen, and the alteration in bacterial flora, normally dominated by Lactobacillus spp., and its metabolites that is characteristic of "nonspecific vaginitis". The authors review microbiologic and clinical aspects of the fungal, protozoal and bacterial infections, including the interactions of bacteria thought to produce nonspecific vaginitis, that are now recognized as causing vaginitis. Other causes of vaginitis are also discussed. PMID:3510698

  6. Development of job standards for clinical nutrition therapy for dyslipidemia patients.

    Science.gov (United States)

    Kang, Min-Jae; Seo, Jung-Sook; Kim, Eun-Mi; Park, Mi-Sun; Woo, Mi-Hye; Ju, Dal-Lae; Wie, Gyung-Ah; Lee, Song-Mi; Cha, Jin-A; Sohn, Cheong-Min

    2015-04-01

    Dyslipidemia has significantly contributed to the increase of death and morbidity rates related to cardiovascular diseases. Clinical nutrition service provided by dietitians has been reported to have a positive effect on relief of medical symptoms or reducing the further medical costs. However, there is a lack of researches to identify key competencies and job standard for clinical dietitians to care patients with dyslipidemia. Therefore, the purpose of this study was to analyze the job components of clinical dietitian and develop the standard for professional practice to provide effective nutrition management for dyslipidemia patients. The current status of clinical nutrition therapy for dyslipidemia patients in hospitals with 300 or more beds was studied. After duty tasks and task elements of nutrition care process for dyslipidemia clinical dietitians were developed by developing a curriculum (DACUM) analysis method. The developed job standards were pretested in order to evaluate job performance, difficulty, and job standards. As a result, the job standard included four jobs, 18 tasks, and 53 task elements, and specific job description includes 73 basic services and 26 recommended services. When clinical dietitians managing dyslipidemia patients performed their practice according to this job standard for 30 patients the job performance rate was 68.3%. Therefore, the job standards of clinical dietitians for clinical nutrition service for dyslipidemia patients proposed in this study can be effectively used by hospitals.

  7. Technical standardization of oil well abandonment: a review of current standards and technologies

    Energy Technology Data Exchange (ETDEWEB)

    Suzart, J. Walter P.; Pessoa, Laudemar; Paiva, Maria [Halliburton Energy Services (HES), Duncan, OK (United States)

    2008-07-01

    The objective of this study is to provide a new methodology for well abandonment. This practice is becoming more and more important because of the increasing number of production fields being abandoned. We strongly recommend a study of cement slurries properties for specific use in temporary and permanent abandonment plugs based on the estimation of the cement slurry hardened when placed in the well. By using specific additives, it is possible to achieve very stable slurries. For example, when permeability is reduced, formation fluid migration can be blocked and chemical reactions between the fluid and the slurry may be inhibited. With this objective, we present a laboratory investigation model and an example of slurry testing recommendation. During the abandonment operation, all records of the well characteristics should be maintained to include the reason for the abandonment, and location of fresh water, brine, and hydrocarbon zones that may exist. This documentation will also allow the analysis of solutions for the problems that originally caused the abandonment of the well. This data could be important for future use by environmental protection commissions to reopen or to drill an adjacent well. Given the high price of oil, it may now be economically feasible to reopen the well, if the reason for abandonment was low productivity. This way, a critical analysis of the current conditions of well and field abandonment in the country is presented. Based on this information, a review of the current standards is suggested. (author)

  8. Terazosin, doxazosin, and prazosin: current clinical experience.

    Science.gov (United States)

    Akduman, B; Crawford, E D

    2001-12-01

    Lower urinary tract symptoms (LUTS) suggestive of benign prostatic obstruction are common in aging men. Nearly 25% of men >40 years of age have LUTS. Medical therapy with alpha-blockade is the most common method of medical therapy for benign prostatic obstruction. Multiple methods of minimally invasive surgical therapies have been introduced in the last decade. These methods include balloon dilatation, temporary and permanent urethral stents, various laser techniques, microwave thermotherapy, transurethral needle ablation, electrovaporization, and high-intensity focused ultrasound. alpha-Receptor blockers to reduce the sympathetic tone of the prostate are considered as first-line therapy to relieve the symptoms of benign prostatic hyperplasia. Selective alpha(1)-receptor blockers relax prostatic smooth muscle, relieve bladder outlet obstruction, and enhance urine flow with fewer side effects. In addition, it was determined that treating patients with alpha-blockers increases prostatic apoptosis. Pharmacokinetic activity, mode of action, clinical efficacy, and side effects of the selective alpha(1)-receptor blockers terazosin, doxazosin, and prazosin are reviewed.

  9. Current clinical evidence on topiramate pharmacokinetics

    Directory of Open Access Journals (Sweden)

    Jakovljević Mihajlo

    2009-01-01

    Full Text Available Topiramate is biochemically classified as a fructopyranose sulphamate. Discovered as early as 1979, during middle 1980's it was approved in many countries for the treatment of epilepsies and migraine prevention. More recently, in the experimental stage, possible new indications have been disclosed: treatment of obesity, bipolar disorder, also cessation of smoking, neuropathic pain, cerebral pseudotumour, bulimia, periventricular leucomalatia in preterm infants and alcohol addiction. Most epileptologists consider it to be the first choice antiepileptic drug in severe pharmacoresistant epilepsies. A substantial corpus of evidence in paediatric population has been accumulated that confirms its efficiency in the treatment of generalised tonic-clonic seizures, Lenox-Gestaut syndrome, partial, absence and combined seizures. Having a unique monosaccharide chemical structure among other anticonvulsant drugs, characterizes it with special pharmacokinetic features. This substance exhibits a low interindividual variability in plasma levels and hence it features predictable pharmacokinetics. A steady state plasma concentration of topiramate increases linearly with higher dosages. Serum protein binding is approximately 15%, and biologic half-life in healthy volunteers is considered to range from 20 to 30 hours. Mean expected distribution volume rates from 0.55-0.8 l/kg, and accordingly, the drug shows a low and saturable binding capacity toward erythrocytes. It has not been present at the market for a sufficiently long time that would enable us to speak about a significant accumulation of data on its metabolism based on post-registration 4th stage clinical trials. For this purpose, we have done a literature review in order to summarise so far reported experience on topiramate pharmacokinetics in patients and healthy adults. Deeper understanding of its pharmacokinetic profile could enable a better technological design of the produced drug and the choice of

  10. Standardization of Administered Activities in Pediatric Nuclear Medicine: A Report of the First Nuclear Medicine Global Initiative Project, Part 2-Current Standards and the Path Toward Global Standardization.

    Science.gov (United States)

    Fahey, Frederic H; Bom, Henry Hee-Seung; Chiti, Arturo; Choi, Yun Young; Huang, Gang; Lassmann, Michael; Laurin, Norman; Mut, Fernando; Nuñez-Miller, Rodolfo; O'Keeffe, Darin; Pradhan, Prasanta; Scott, Andrew M; Song, Shaoli; Soni, Nischal; Uchiyama, Mayuki; Vargas, Luis

    2016-07-01

    The Nuclear Medicine Global Initiative (NMGI) was formed in 2012 and consists of 13 international organizations with direct involvement in nuclear medicine. The underlying objectives of the NMGI are to promote human health by advancing the field of nuclear medicine and molecular imaging, encourage global collaboration in education, and harmonize procedure guidelines and other policies that ultimately lead to improvements in quality and safety in the field throughout the world. For its first project, the NMGI decided to consider the issues involved in the standardization of administered activities in pediatric nuclear medicine. It was decided to divide the final report of this project into 2 parts. Part 1 was published in this journal in the spring of 2015. This article presents part 2 of the final report. It discusses current standards for administered activities in children and adolescents that have been developed by various professional organizations. It also presents an evaluation of the current practice of pediatric nuclear medicine specifically with regard to administered activities as determined by an international survey of 313 nuclear medicine clinics and centers from 29 countries. Lastly, it provides recommendations for a path toward global standardization of the administration of radiopharmaceuticals in children.

  11. Clinical decision rules for acute bacterial meningitis: current insights

    Directory of Open Access Journals (Sweden)

    Viallon A

    2016-04-01

    Full Text Available Alain Viallon,1 Elisabeth Botelho-Nevers,2 Fabrice Zeni3 1Emergency Department, 2Department of Infectious Disease, 3Intensive Care Unit, University Hospital, Saint-Etienne, France Abstract: Acute community-acquired bacterial meningitis (BM requires rapid diagnosis so that suitable treatment can be instituted within 60 minutes of admitting the patient. The cornerstone of diagnostic examination is lumbar puncture, which enables microbiological analysis and determination of the cerebrospinal fluid (CSF cytochemical characteristics. However, microbiological testing is not sufficiently sensitive to rule out this diagnosis. With regard to the analysis of standard CSF cytochemical characteristics (polymorphonuclear count, CSF glucose and protein concentration, and CSF:serum glucose, this is often misleading. Indeed, the relatively imprecise nature of the cutoff values for these BM diagnosis markers can make their interpretation difficult. However, there are two markers that appear to be more efficient than the standard ones: CSF lactate and serum procalcitonin levels. Scores and predictive models are also available; however, they only define a clinical probability, and in addition, their use calls for prior validation on the population in which they are used. In this article, we review current methods of BM diagnosis. Keywords: meningitis, diagnosis, emergency

  12. Current Account Balance and Dollar Standard: Exploring the Linkages

    NARCIS (Netherlands)

    Steiner, Adreas

    2014-01-01

    This paper examines whether the international role of the dollar as main global reserve currency has contributed to persistent current account imbalances. To this end, we analyse how central banks' accumulation of reserve assets affects the current account balance of both reserve-accumulating and re

  13. Quality standards for rheumatology outpatient clinic. The EXTRELLA project.

    Science.gov (United States)

    Nolla, Joan M; Martínez, Carmen; García-Vicuña, Rosario; Seoane-Mato, Daniel; Rosario Lozano, M Piedad; Alonso, Alberto; Alperi, Mercedes; Barbazán, Ceferino; Calvo, Jaime; Delgado, Concepción; Fernández-Nebro, Antonio; Mateo, Lourdes; Pérez Sandoval, Trinidad; Pérez Venegas, José; Rodríguez Lozano, Carlos; Rosas, José

    2016-01-01

    In recent years, outpatient clinics have undergone extensive development. At present, patients with rheumatic diseases are mainly assisted in this area. However, the quality standards of care are poorly documented. To develop specific quality criteria and standards for an outpatient rheumatology clinic. The project was based on the two-round Delphi method. The following groups of participants took part: scientific committee (13 rheumatologists), five nominal groups (45 rheumatologists and 12 nurses) and a group of discussion formed by 9 patients. Different drafts were consecutively generated until a final document was obtained that included the standards that received a punctuation equal or over 7 in at least 70% of the participants. 148 standards were developed, grouped into the following 9 dimensions: a) structure (22), b) clinical activity and relationship with the patients (34), c) planning (7), d) levels of priority (5), e) relations with primary care physicians, with Emergency Department and with other clinical departments, f) process (26), g) nursing (13), h) teaching and research (13) and i) activity measures (8). This study established specific quality standards for rheumatology outpatient clinic. It can be a useful tool for organising this area in the Rheumatology Department and as a reference when proposing improvement measures to health administrators. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  14. Clinical data exchange standards and vocabularies for messages.

    Science.gov (United States)

    Huff, S M

    1998-01-01

    Motivation for the creation of electronic data interchange (message) standards is discussed. The ISO Open Systems Interface model is described. Clinical information models, message syntax and structure, and the need for a standardized coded vocabulary are explained. The HIPAA legislation and subsequent HHS transaction recommendations are reviewed. The history and mission statements of six of the most popular message development organizations (MDOs) are summarized, and the data exchange standards developed by these organizations are listed. The organizations described include Health Level Seven (HL7), American Standards for Testing and Materials (ASTM) E31, Digital Image Communication in Medicine (DICOM), European Committee for Standardization (Comité Européen de Normalisation), Technical Committee for Health Informatics (CEN/TC 251), the National Council for Prescription Drug Programs (NCPDP), and Accredited Standards Committee X12 Insurance Subcommittee (X12N). The locations of Internet web sites for the six organizations are provided as resources for further information.

  15. Alignment of Elementary Geometry Curriculum with Current Standards.

    Science.gov (United States)

    Pickreign, Jamar; Capps, Lelon R.

    2000-01-01

    Examines geometry language used in K-6 textbooks and compares the findings to language used in modern mathematics standards documents. Finds a substantial misalignment between the geometry presented in textbooks, the geometry teaching expectations of mathematics education professionals, and the geometry being assessed in student performance…

  16. Parachute drawing standards currently in use at Sandia National Laboratories

    Energy Technology Data Exchange (ETDEWEB)

    Ronquillo, K.L.

    1988-01-01

    A need exists in the parachute industry for a standard method of defining and guiding the formation of textile drawings. Textile drawings have their own unique problems associated with their development. Unlike mechanical parts, textiles have no mass in cross section. Therefore, a cross-sectioned view has no hash marks. Hidden views are not usually incorporated in textile drawings as they are easily confused with stitch formations. Side views of textile parts are depicted using only one line to show thickness. This report will address these and other unique drawing problems associated with the development of parachute drawings and will offer, as a base, standards to be used when developing these drawings. 21 figs.

  17. Current Standards in the Management of Cerebral Metastases

    Directory of Open Access Journals (Sweden)

    Pablo Goetz

    2012-01-01

    Full Text Available The last 30 years have seen major changes in attitude toward patients with cerebral metastases. This paper aims to outline the major landmarks in this transition and the therapeutic strategies currently used. The controversies surrounding control of brain disease are discussed, and two emerging management trends are reviewed: tumor bed radiosurgery and salvage radiation.

  18. Recommendation for modifying current cytotoxicity testing standards for biodegradable magnesium-based materials.

    Science.gov (United States)

    Wang, Jiali; Witte, Frank; Xi, Tingfei; Zheng, Yufeng; Yang, Ke; Yang, Yuansheng; Zhao, Dewei; Meng, Jian; Li, Yangde; Li, Weirong; Chan, Kaiming; Qin, Ling

    2015-07-01

    As one of the most promising medical metal implants, magnesium (Mg) or its alloys have shown significant advantages over other candidates attributed to not only their excellent biodegradability and suitable mechanical properties but also their osteopromotive effects for bone applications. Prior to approval mandated by the governmental regulatory body, the access to the medical market for Mg-based implants requires a series of testing for assurance of their safety and efficacy via preclinical evaluations and clinical tests including phase 1 and 2 evaluations, and phase 3 of multi-center randomized double blind and placebo-controlled clinical trials. However, as the most widely used protocols for biosafety evaluation of medical devices, current ISO 10993 standards should be carefully reevaluated when directly applying them to predict potential health risks of degradable Mg based biomaterials via cytotoxicity tests due to the huge gap between in vitro and in vivo conditions. Therefore, instead of a direct adoption, modification of current ISO standards for in vitro cytotoxicity test is desirable and justified. The differences in sensitivities of cells to in vitro and in vivo Mg ions and the capability of in vivo circulation system to dilute local degradation products were fully considered to propose modification of current ISO standards. This paper recommended a minimal 6 times to a maximal 10 times dilution of extracts for in vitro cytotoxicity test specified in ISO 10993 part 5 for pure Mg developed as potential orthopedic implants based on literature review and our specifically designed in vitro and in vivo tests presented in the study. Our work may contribute to the progress of biodegradable metals involved translational work. Copyright © 2015 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.

  19. Current Standards and Novel Treatment Options for Metastatic Pancreatic Adenocarcinoma.

    Science.gov (United States)

    Weinberg, Benjamin A; Yabar, Cinthya S; Brody, Jonathan R; Pishvaian, Michael J

    2015-11-01

    Pancreatic cancer is one of the most lethal solid tumors. The prognosis of metastatic pancreatic adenocarcinoma remains dismal, with a median survival of less than 1 year, due in large part to the fact that pancreatic adenocarcinoma is notoriously refractory to chemotherapy. However, there recently have been significant improvements in outcomes for patients with pancreatic adenocarcinoma: ongoing trials have shown promise, and these may lead to still further progress. Here we review the current treatment paradigms for metastatic disease, focusing on ways to ameliorate symptoms and lengthen survival. We then summarize recent advances in our understanding of the molecular and cellular aspects of pancreatic cancer. Finally, we outline new approaches currently under development for the treatment of metastatic disease, arising from our improved understanding of the genetic and nongenetic alterations within pancreatic cancer cells-and of interactions between cancer cells, the tumor microenvironment, and the immune system.

  20. A New International Standard for "Actions from Waves and Currents on Coastal Structures"

    DEFF Research Database (Denmark)

    Tørum, Alf; Burcharth, Hans F.; Goda, Yoshimi

    2007-01-01

    The International Organization for Standardization (ISO) is going to issue a new standard concerning "Actions from Waves and Currents on Coastal Structures," which becomes the first international standard in coastal engineering. It is composed of a normative part (29 pages), an informative part (80...... standard on coastal engineering practice....

  1. Quality-of-care standards for early arthritis clinics.

    Science.gov (United States)

    Ivorra, José Andrés Román; Martínez, Juan Antonio; Lázaro, Pablo; Navarro, Federico; Fernandez-Nebro, Antonio; de Miguel, Eugenio; Loza, Estibaliz; Carmona, Loreto

    2013-10-01

    The diagnosis and treatment of early arthritis is associated with improved patient outcomes. One way to achieve this is by organising early arthritis clinics (EACs). The objective of this project was to develop standards of quality for EACs. The standards were developed using the two-round Delphi method. The questionnaire, developed using the best-available scientific evidence, includes potentially relevant items describing the dimensions of quality of care in the EAC. The questionnaire was completed by 26 experts (physicians responsible for the EACs in Spain and chiefs of the rheumatology service in Spanish hospitals). Two hundred and forty-four items (standards) describing the quality of the EAC were developed, grouped by the following dimensions: (1) patient referral to the EAC; (2) standards of structure for an EAC; (3) standards of process; (4) relation between primary care physicians and the EAC; (5) diagnosis and assessment of early arthritis; (6) patient treatment and follow-up in the EAC; (7) research and training in an EAC; and (8) quality of care perceived by the patient. An operational definition of early arthritis was also developed based on eight criteria. The standards developed can be used to measure/establish the requirements, resources, and processes that EACs have or should have to carry out their treatment, research, and educational activities. These standards may be useful to health professionals, patient associations, and health authorities.

  2. Current and future standards in evaluation of erectile dysfunction

    Directory of Open Access Journals (Sweden)

    Raymond W Pak

    2006-01-01

    Full Text Available Sexual dysfunction and more specifically erectile dysfunction (ED can be a harbinger of serious occult medical conditions. ED can be considered a clinical manifestation of generalized vascular disease and therefore shares similar risk factors: aging, hypertension, diabetes mellitus, hypercholesterolemia and smoking. The initial evaluation of men with ED should be thorough. Studies of normal and abnormal penile tumescence have led to the discovery of many important pathways. The greatest medical advance in the management of male sexual dysfunction since the identification of androgens have been the discoveries that nitric oxide (NO is the primary neuro-modulator of penile smooth muscle relaxation and that oral phosphodiesterase type 5 inhibitors enhance erection quality through the NO mechanism. As a consequence of oral pharmacotherapies, the role of invasive diagnostics has diminished. Most guidelines recommend only history, physical exam and limited laboratory testing prior to instituting oral therapies for ED. In 2006 we still have unanswered questions about ED and these will frame the role of future diagnosis and therapy: can lifestyle changes alone improve erectile function; is ED a marker for the development of atherosclerotic heart disease, do lower urinary tract symptoms of benign prostatic hypertrophy and ED share a common pathway?

  3. Fundamentals of randomized clinical trials in wound care: reporting standards.

    Science.gov (United States)

    Brölmann, Fleur E; Eskes, Anne M; Sumpio, Bauer E; Mayer, Dieter O; Moore, Zena; Agren, Magnus S; Hermans, Michel; Cutting, Keith; Legemate, Dink A; Vermeulen, Hester; Ubbink, Dirk T

    2013-01-01

    In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care. Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta-analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.

  4. Clinical Education In psychiatric mental health nursing: Overcoming current challenges.

    Science.gov (United States)

    Choi, Heeseung; Hwang, Boyoung; Kim, Sungjae; Ko, Heesung; Kim, Sumi; Kim, Chanhee

    2016-04-01

    In response to current challenges in psychiatric mental health nursing education, nursing schools have implemented new strategies in teaching undergraduate nursing students. The objectives of the study were to evaluate learning outcomes of a mental health nursing clinical practicum and to explore students' perceptions of the clinical practicum. This was a mixed-method study. Sixty-three undergraduate nursing students, who were undertaking their first mental health clinical practicum, completed a set of structured questionnaires and answered open-ended questions about the clinical practicum. Answers to open-ended questions were analyzed qualitatively, and learning outcomes (i.e., empathy, mental illness prejudice, simulation-related efficacy, and satisfaction) were measured at three time points: pre-clinical, post-simulation, and post-clinical. Students reported improvement in empathy and simulation-related self-efficacy after the clinical practicum, but no change was found in mental illness prejudice. Students' expectations for and evaluation of the clinical practicum are summarized. The observed improvement in learning outcomes of the clinical practicum may be attributed to the unique contribution of each component of the clinical practicum and the synergic effect of these diverse components. To manage emerging challenges in clinical settings and nursing education, it is critical to develop systematic and comprehensive mental health nursing clinical practicums for undergraduate nursing students. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. E-health stakeholders experiences with clinical modelling and standardizations.

    Science.gov (United States)

    Gøeg, Kirstine Rosenbeck; Elberg, Pia Britt; Højen, Anne Randorff

    2015-01-01

    Stakeholders in e-health such as governance officials, health IT-implementers and vendors have to co-operate to achieve the goal of a future-proof interoperable e-health infrastructure. Co-operation requires knowledge on the responsibility and competences of stakeholder groups. To increase awareness on clinical modeling and standardization we conducted a workshop for Danish and a few Norwegian e-health stakeholders' and made them discuss their views on different aspects of clinical modeling using a theoretical model as a point of departure. Based on the model, we traced stakeholders' experiences. Our results showed there was a tendency that stakeholders were more familiar with e-health requirements than with design methods, clinical information models and clinical terminology as they are described in the scientific literature. The workshop made it possible for stakeholders to discuss their roles and expectations to each other.

  6. Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses.

    Science.gov (United States)

    Pavšič, Jernej; Devonshire, Alison S; Parkes, Helen; Schimmel, Heinz; Foy, Carole A; Karczmarczyk, Maria; Gutiérrez-Aguirre, Ion; Honeyborne, Isobella; Huggett, Jim F; McHugh, Timothy D; Milavec, Mojca; Zeichhardt, Heinz; Žel, Jana

    2015-07-01

    Nucleic acid-based tests for infectious diseases currently used in the clinical laboratory and in point-of-care devices are diverse. Measurement challenges associated with standardization of quantitative viral load testing are discussed in relation to human cytomegalovirus, BK virus, and Epstein-Barr virus, while the importance of defining the performance of qualitative methods is illustrated with Mycobacterium tuberculosis and influenza virus. The development of certified reference materials whose values are traceable to higher-order standards and reference measurement procedures, using, for instance, digital PCR, will further contribute to the understanding of analytical performance characteristics and promote clinical data comparability.

  7. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes.

    Science.gov (United States)

    Sharma, Deepak K; Solbrig, Harold R; Prud'hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary's metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration.

  8. Standardized Representation of Clinical Study Data Dictionaries with CIMI Archetypes

    Science.gov (United States)

    Sharma, Deepak K.; Solbrig, Harold R.; Prud’hommeaux, Eric; Pathak, Jyotishman; Jiang, Guoqian

    2016-01-01

    Researchers commonly use a tabular format to describe and represent clinical study data. The lack of standardization of data dictionary’s metadata elements presents challenges for their harmonization for similar studies and impedes interoperability outside the local context. We propose that representing data dictionaries in the form of standardized archetypes can help to overcome this problem. The Archetype Modeling Language (AML) as developed by the Clinical Information Modeling Initiative (CIMI) can serve as a common format for the representation of data dictionary models. We mapped three different data dictionaries (identified from dbGAP, PheKB and TCGA) onto AML archetypes by aligning dictionary variable definitions with the AML archetype elements. The near complete alignment of data dictionaries helped map them into valid AML models that captured all data dictionary model metadata. The outcome of the work would help subject matter experts harmonize data models for quality, semantic interoperability and better downstream data integration. PMID:28269909

  9. Clinical pharmacology in Russia-historical development and current state.

    Science.gov (United States)

    Zagorodnikova Goryachkina, Ksenia; Burbello, Aleksandra; Sychev, Dmitry; Frolov, Maxim; Kukes, Vladimir; Petrov, Vladimir

    2015-02-01

    Clinical pharmacology in Russia has long history and is currently active, but rather unrecognized internationally. It is governmentally approved as a teaching/scientific specialty since 1983 and as a medical specialty since 1997. Courses of clinical pharmacology are included in the undergraduate curricula in the 5th and/or 6th year of education at all medical schools in the Russian Federation. Postgraduate education includes initial specialization in internal medicine with further residency in clinical pharmacology. Governmental legislation recommends that every healthcare institution has either a department or a single position of clinical pharmacologist. Major routine duties include information about and monitoring of medication use, consultations in difficult clinical situations, pharmacogenetic counseling, therapeutic drug monitoring, pharmacovigilance, and participation in drug and therapeutics (formulary) committees. There are official experts in clinical pharmacology in Russia responsible for coordinating relevant legislative issues. The chief expert clinical pharmacologist represents the discipline directly at the Ministry of Health. Research in clinical pharmacology in Russia is extensive and variable, but only some of it is published internationally. Russia is a participant of international societies of clinical pharmacology and therapeutics and collaboration is actively ongoing. There are still certain problems related to the development of the discipline in Russia-some healthcare institutions do not see the need for clinical pharmacology. However, the number of clinical pharmacologists in Russia is increasing as well as their role in physicians' education, national healthcare, and research.

  10. Standardizing data exchange for clinical research protocols and case report forms: An assessment of the suitability of the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM).

    Science.gov (United States)

    Huser, Vojtech; Sastry, Chandan; Breymaier, Matthew; Idriss, Asma; Cimino, James J

    2015-10-01

    Efficient communication of a clinical study protocol and case report forms during all stages of a human clinical study is important for many stakeholders. An electronic and structured study representation format that can be used throughout the whole study life-span can improve such communication and potentially lower total study costs. The most relevant standard for representing clinical study data, applicable to unregulated as well as regulated studies, is the Operational Data Model (ODM) in development since 1999 by the Clinical Data Interchange Standards Consortium (CDISC). ODM's initial objective was exchange of case report forms data but it is increasingly utilized in other contexts. An ODM extension called Study Design Model, introduced in 2011, provides additional protocol representation elements. Using a case study approach, we evaluated ODM's ability to capture all necessary protocol elements during a complete clinical study lifecycle in the Intramural Research Program of the National Institutes of Health. ODM offers the advantage of a single format for institutions that deal with hundreds or thousands of concurrent clinical studies and maintain a data warehouse for these studies. For each study stage, we present a list of gaps in the ODM standard and identify necessary vendor or institutional extensions that can compensate for such gaps. The current version of ODM (1.3.2) has only partial support for study protocol and study registration data mainly because it is outside the original development goal. ODM provides comprehensive support for representation of case report forms (in both the design stage and with patient level data). Inclusion of requirements of observational, non-regulated or investigator-initiated studies (outside Food and Drug Administration (FDA) regulation) can further improve future revisions of the standard.

  11. A standardized clinical evaluation of phenotypic diversity in diabetic polyneuropathy.

    Science.gov (United States)

    Scholz, Joachim; Rathmell, James P; David, William S; Chad, David A; Broderick, Alithia C; Perros, Stephen G; Shin, Naomi S; Wells, Jenna L; Davis, John B; DiMaggio, Charles J; Wang, Shuang; Tate, Simon N

    2016-10-01

    Diabetic polyneuropathy (DPN) is a major cause of neuropathic pain and a frequent target condition in analgesic treatment trials. Differences in the clinical symptoms and signs associated with DPN suggest distinct pathophysiological mechanisms underlying nerve damage and dysfunction that are likely to have therapeutic relevance. The aim of this study was to develop a tool for the bedside assessment of painful neuropathies such as DPN that captures the diversity of phenotypes. Sixty-one patients with type 2 diabetes and painful neuropathy, 19 patients with painless DPN, 25 patients with type 2 diabetes but no clinical evidence of neuropathy, and 20 healthy control subjects completed a structured interview (47 items) and a standardized physical examination (39 items). After analyzing critical features of pain and painless symptoms and examining the outcome of physical tests of sensory function, we determined principal components of the phenotypic variance among patients. Increased sensitivity to mechanical or thermal stimuli and, to a lesser extent, the sensory quality of pain or paresthesia were the most discriminating elements of DPN phenotypes. Correlation patterns of symptoms and signs indicated the involvement of functionally distinct nerve fiber populations. We combined interview questions and physical tests identifying these differences in a shortened assessment protocol that we named Standardized Evaluation of Pain and Somatosensory Function (StEPS). The protocol StEPS generates a phenotypic profile of patients with neuropathy. Separate intensity ratings for spontaneous painful symptoms and pain evoked by standard stimuli support a detailed documentation of neuropathic pain and its response to analgesic treatment.

  12. NUCLEAR CARDIOLOGY, CURRENT APPLICATIONS IN CLINICAL-PRACTICE

    NARCIS (Netherlands)

    NIEMEYER, MG; VANDERWALL, EE; KUIJPER, AFM; CLEOPHAS, AT; PAUWELS, EKJ

    1995-01-01

    The clinical applications of nuclear cardiology have rapidly expanded since the introduction of suitable imaging cameras and readily applicable isotopes. The currently available methods can provide useful data on estimates of ventricular function and detection of myocardial ischemia for adequate pat

  13. Application of radiotherapy for hepatocellular carcinoma in current clinical practice guidelines

    Energy Technology Data Exchange (ETDEWEB)

    Rim, Chai Hong; Seong, Jin Sil [Dept. of Radiation Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul (Korea, Republic of)

    2016-09-15

    In oncologic practice, treatment guidelines provide appropriate treatment strategies based on evidence. Currently, many guidelines are used, including those of the European Association for the Study of the Liver and European Organization for Research and Treatment of Cancer (EASL-EORTC), National Comprehensive Cancer Network (NCCN), Asia-Pacific Primary Liver Cancer Expert (APPLE), and Korean Liver Cancer Study Group and National Cancer Centre (KLCSG-NCC). Although radiotherapy is commonly used in clinical practice, some guidelines do not accept it as a standard treatment modality. In this review, we will investigate the clinical practice guidelines currently used, and discuss the application of radiotherapy.

  14. Virtual glaucoma clinics: patient acceptance and quality of patient education compared to standard clinics

    Directory of Open Access Journals (Sweden)

    Court JH

    2015-04-01

    Full Text Available Jennifer H Court,1 Michael W Austin1,21Department of Ophthalmology, Singleton Hospital, Swansea, Wales, UK; 2Department of Ophthalmology, Neath Port Talbot Hospital, Swansea, Wales, UKPurpose: Virtual glaucoma clinics allow rapid, reliable patient assessment but the service should be acceptable to patients and concordance with treatment needs to be maintained with adequate patient education. This study compares experiences and understanding of patients reviewed via the virtual clinic versus the standard clinic by way of an extended patient satisfaction questionnaire (PSQ.Patients and methods: One hundred PSQs were given to consecutive patients attending glaucoma clinics in October 2013. All 135 patients reviewed via the virtual clinic from April 2013 until August 2013 were sent postal PSQs in September 2013. Data were obtained for demographics, understanding of glaucoma, their condition, satisfaction with their experience, and quality of information. Responses were analyzed in conjunction with the clinical records.Results: Eighty-five percent of clinic patients and 63% of virtual clinic patients responded to the PSQ. The mean satisfaction score was over 4.3/5 in all areas surveyed. Virtual clinic patients’ understanding of their condition was very good, with 95% correctly identifying their diagnosis as glaucoma, 83% as ocular hypertension and 78% as suspects. There was no evidence to support inferior knowledge or self-perceived understanding compared to standard clinic patients. Follow-up patients knew more about glaucoma than new patients. Over 95% of patients found our information leaflet useful. Forty percent of patients sought additional information but less than 20% used the internet for this.Conclusion: A substantial proportion of glaucoma pathway patients may be seen by non-medical staff supervised by glaucoma specialists via virtual clinics. Patients are accepting of this format, reporting high levels of satisfaction and non

  15. Mineralized Collagen: Rationale, Current Status, and Clinical Applications

    Directory of Open Access Journals (Sweden)

    Zhi-Ye Qiu

    2015-07-01

    Full Text Available This paper presents a review of the rationale for the in vitro mineralization process, preparation methods, and clinical applications of mineralized collagen. The rationale for natural mineralized collagen and the related mineralization process has been investigated for decades. Based on the understanding of natural mineralized collagen and its formation process, many attempts have been made to prepare biomimetic materials that resemble natural mineralized collagen in both composition and structure. To date, a number of bone substitute materials have been developed based on the principles of mineralized collagen, and some of them have been commercialized and approved by regulatory agencies. The clinical outcomes of mineralized collagen are of significance to advance the evaluation and improvement of related medical device products. Some representative clinical cases have been reported, and there are more clinical applications and long-term follow-ups that currently being performed by many research groups.

  16. Bimodal Programming: A Survey of Current Clinical Practice.

    Science.gov (United States)

    Siburt, Hannah W; Holmes, Alice E

    2015-06-01

    The purpose of this study was to determine the current clinical practice in approaches to bimodal programming in the United States. To be specific, if clinicians are recommending bimodal stimulation, who programs the hearing aid in the bimodal condition, and what method is used for programming the hearing aid? An 11-question online survey was created and sent via email to a comprehensive list of cochlear implant programming centers in the United States. The survey was sent to 360 recipients. Respondents in this study represented a diverse group of clinical settings (response rate: 26%). Results indicate little agreement about who programs the hearing aids, when they are programmed, and how they are programmed in the bimodal condition. Analysis of small versus large implant centers indicated small centers are less likely to add a device to the contralateral ear. Although a growing number of cochlear implant recipients choose to wear a hearing aid on the contralateral ear, there is inconsistency in the current clinical approach to bimodal programming. These survey results provide evidence of large variability in the current bimodal programming practices and indicate a need for more structured clinical recommendations and programming approaches.

  17. Guidelines International Network: toward international standards for clinical practice guidelines.

    Science.gov (United States)

    Qaseem, Amir; Forland, Frode; Macbeth, Fergus; Ollenschläger, Günter; Phillips, Sue; van der Wees, Philip

    2012-04-03

    Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. Institute of Medicine and the United Kingdom's National Institute for Health and Clinical Excellence have developed recommendations to define trustworthy guidelines within their locales. Many groups charged with guideline development find the lengthy list of standards developed by such organizations to be aspirational but infeasible to follow in entirety. Founded in 2002, the Guidelines International Network (G-I-N) is a network of guideline developers that includes 93 organizations and 89 individual members representing 46 countries. The G-I-N board of trustees recognized the importance of guideline development processes that are both rigorous and feasible even for modestly funded groups to implement and initiated an effort toward consensus about minimum standards for high-quality guidelines. In contrast to other existing standards for guideline development at national or local levels, the key components proposed by G-I-N will represent the consensus of an international, multidisciplinary group of active guideline developers. This article presents G-I-N's proposed set of key components for guideline development. These key components address panel composition, decision-making process, conflicts of interest, guideline objective, development methods, evidence review, basis of recommendations, ratings of evidence and recommendations, guideline review, updating processes, and funding. It is hoped that this article promotes discussion and eventual agreement on a set of international standards for guideline development.

  18. The current state of clinical interpretation of sequence variants.

    Science.gov (United States)

    Hoskinson, Derick C; Dubuc, Adrian M; Mason-Suares, Heather

    2017-01-31

    Accurate and consistent variant classification is required for Precision Medicine. But clinical variant classification remains in its infancy. While recent guidelines put forth jointly by the American College of Medical Genetics and Genomics (ACMG) and Association of Molecular Pathology (AMP) for the classification of Mendelian variants has advanced the field, the degree of subjectivity allowed by these guidelines can still lead to inconsistent classification across clinical molecular genetic laboratories. In addition, there are currently no such guidelines for somatic cancer variants, only published institutional practices. Additional variant classification guidelines, including disease- or gene-specific criteria, along with inter-laboratory data sharing is critical for accurate and consistent variant interpretation.

  19. Nausea: current knowledge of mechanisms, measurement and clinical impact.

    Science.gov (United States)

    Kenward, Hannah; Pelligand, Ludovic; Savary-Bataille, Karine; Elliott, Jonathan

    2015-01-01

    Nausea is a subjective sensation, which often acts as a signal that emesis is imminent. It is a widespread problem that occurs as a clinical sign of disease or as an adverse effect of a drug therapy or surgical procedure. The mechanisms of nausea are complex and the neural pathways are currently poorly understood. This review summarises the current knowledge of nausea mechanisms, the available animal models for nausea research and the anti-nausea properties of commercially available anti-emetic drugs. The review also presents subjective assessment and scoring of nausea. A better understanding of the underlying mechanisms of nausea might reveal potential clinically useful biomarkers for objective measurement of nausea in species of veterinary interest.

  20. Animal models of frailty: current applications in clinical research.

    Science.gov (United States)

    Kane, Alice E; Hilmer, Sarah N; Mach, John; Mitchell, Sarah J; de Cabo, Rafael; Howlett, Susan E

    2016-01-01

    The ethical, logistical, and biological complications of working with an older population of people inherently limits clinical studies of frailty. The recent development of animal models of frailty, and tools for assessing frailty in animal models provides an invaluable opportunity for frailty research. This review summarizes currently published animal models of frailty including the interleukin-10 knock-out mouse, the mouse frailty phenotype assessment tool, and the mouse clinical frailty index. It discusses both current and potential roles of these models in research into mechanisms of frailty, interventions to prevent/delay frailty, and the effect of frailty on outcomes. Finally, this review discusses some of the challenges and opportunities of translating research findings from animals to humans.

  1. Current status of clinical laser applications in periodontal therapy.

    Science.gov (United States)

    Aoki, Akira; Mizutani, Koji; Takasaki, Aristeo Atsushi; Sasaki, Katia Miyuki; Nagai, Shigeyuki; Schwarz, Frank; Yoshida, Itaru; Eguro, Toru; Zeredo, Jorge Luis; Izumi, Yuichi

    2008-01-01

    Periodontal disease is a chronic inflammatory disorder caused by bacterial infection. Laser treatment demonstrates specific characteristics that may be valuable in managing periodontal disease. In addition, lasers reduce stress and uncomfortable conditions for patients during and after treatment compared to other conventional tools. This article reviews the literature to describe the current clinical applications of lasers for gingival tissue management-including esthetic treatment, non-surgical and surgical periodontal pocket therapy, osseous surgery, and implant therapy.

  2. Current Evidence on Atypical Odontalgia: Diagnosis and Clinical Management

    OpenAIRE

    Yoshihiro Abiko; Hirofumi Matsuoka; Itsuo Chiba; Akira Toyofuku

    2012-01-01

    Patients with atypical odontalgia (AO) complain of medically unexplained toothache. No evidence-based diagnostic criteria or treatment guidelines are yet available. The present paper addresses seven clinical questions about AO based on current knowledge in the literature and discusses diagnostic criteria and guidelines for treatment and management. The questions are (i) What is the prevalence of AO in the community? (ii) What psychological problems are experienced by patients with AO? (iii) A...

  3. Treatment of sepsis: current status of clinical immunotherapy.

    LENUS (Irish Health Repository)

    O'Callaghan, A

    2012-02-03

    While antibiotics address the root cause of sepsis--that of pathogen infection--they fail to provide an adequate cure for the condition. Currently, 30% to 50% of septic patients die, and this figure is likely to increase in line with the proliferation of multi-drug resistant bacteria. With an increased understanding of the immune response, it has been proposed that modulation of this defence mechanism offers the best hope of cure. Many entry-points in the immune system have been identified and targeted therapies have been developed,but why are these not in routine clinical practice? This review examines the latest evidence for the use of immuno-modulating drugs, obtained from human clinical trials. We discuss cytokine-based therapies, steroids and anti-coagulants. Finally, consideration is given as to why successful therapies in the laboratory, and in vivo models, do not automatically translate into clinical benefit

  4. The evolution of a clinical database: from local to standardized clinical languages.

    Science.gov (United States)

    Prophet, C. M.

    2000-01-01

    For more than twenty years, the University of Iowa Hospitals and Clinics Nursing Informatics (UIHC NI) has been developing a clinical database to support patient care planning and documentation in the INFORMM NIS (Information Network for Online Retrieval & Medical Management Nursing Information System). Beginning in 1992, the database content was revised to standardize orders and to incorporate the Standardized Nursing Languages (SNLs) of the North American Nursing Diagnosis Association (NANDA), Nursing Diagnosis Extension Classification (NDEC), Nursing Interventions Classification (NIC), and Nursing Outcomes Classification (NOC). This paper reports the results of the database revision as well as recent usage data, new user selection methods for clinical content, and the advantages of a database utilizing SNLs. PMID:11079966

  5. Integrating genomics into clinical practice: standards and regulatory challenges.

    Science.gov (United States)

    Shabo, Amnon

    2008-06-01

    Bridging between the worlds of healthcare and life sciences is crucial to realizing the personalized healthcare vision. Initiatives regarding legislation and regulation in this interdisciplinary field, along with significant advancement in the development of data standards for genotype-phenotype associations, give rise to a banking paradigm in the form of both biobanks and independent health record banks (IHRBs). These data banks are the information technology infrastructures that are expected to enable the implementation of personalized healthcare. As opposed to the regional strategy currently piloted in the US, IHRBs offer an alternative constellation to achieving a nationwide health information network and the bills introduced in the US Congress relating to these data banks have stimulated public discussion on how best to personalize the care process.

  6. [Clinical diagnosis and standardized evaluation of borderline personality: preliminary report].

    Science.gov (United States)

    Chaine, F; Guelfi, J D; Monier, C; Brun, A; Seunevel, F

    1995-01-01

    A sample of 36 patients considered by French clinicians as suffering from a borderline personality disorder was evaluated using the International Personality Disorder Examination, the Diagnostic Interview for Borderline-Revised, and the Minnesota Multiphasic Personality Inventory. First, global descriptive analysis of the sample elicited the socio-demographic and standard clinical characteristics of the borderline individuals. After diagnostic evaluation, the sample appeared to be quite homogeneous with 25 of the 36 patients evaluated (69.5%) being defined as borderline by two of the three diagnostic systems: ICD 10, DSM III-R and Gunderson (15/36 = 41.5% of patients were defined as borderline by all three systems). It is the types of BL personality co-diagnoses which differentiated the BL subjects in the sample from those classically described in the international literature, since the most frequent personalities were the Dependent and Avoiding ones, not the Antisocial, Histrionic, Narcissistic or Schizotypic personalities of the DSM III-R. ICD 10 elicited the same significant prevalence of Anxious and Dependent personalities. Lastly, the patients diagnosed as borderline both by clinicians and by all diagnostic systems (forming the sample "core") were compared with the rest of the sample with regard to socio-demographic, clinical and diagnostic characteristics. A few hypotheses are proposed on the type of variables that may permit to discriminate between these two types of patients.

  7. Current Status of International Airborne Platform Data and Instrument Interface Standards

    Science.gov (United States)

    Freer, Matt; Webster, Chris; Freundinger, Larry

    2016-06-01

    Commission I of the International Society for Photogrammetric and Remote Sensing formed working group I/1 for the purpose of standardizing airborne platform interfaces. The primary mission of this working group is to promote the standardization of instrument interfaces, data formats, and supporting infrastructures; and to facilitate more efficient, flexible, and cost-effective international science flight operations. Within WGI/1 are a number of focused subgroups. This paper addresses the efforts of some of these subgroups having interdependent and overlapping interests; including the development of standard software interfaces for sensors, standardized approaches to management of information over potentially intermittent wireless data links, the development of standardized processing algorithms, and data archival format standards. The data in this report reflect the outcome of work-to-date in the current subgroups.

  8. Clinical utility of ivabradine in cardiovascular disease management: current status

    Directory of Open Access Journals (Sweden)

    Rosano GMC

    2014-08-01

    Full Text Available Giuseppe MC Rosano,1,2 Cristiana Vitale,1,2 Ilaria Spoletini,1 Maurizio Volterrani11Department of Medical Sciences, IRCCS San Raffaele Pisana, Rome, Italy; 2Cardiovascular and Cell Sciences Research Institute, St George's University of London, London, UK Abstract: Ivabradine is a selective antagonist of the funny channels with anti-anginal and anti-ischemic properties, approved for the treatment of coronary artery disease (CAD and heart failure (HF. It provides pure heart rate reduction, reducing the diastolic depolarization slope, without altering hemodynamic parameters. This review summarizes the current knowledge on the efficacy of ivabradine in patients with cardiovascular diseases, with a particular focus on its role in the clinical management of patients with CAD and HF. There is consistent evidence that ivabradine is effective in reducing angina pectoris symptoms and myocardial ischemia. At approved doses ivabradine is safe, improves exercise tolerance, and reduces heart rate. Available data from clinical trials support its use in the management of patients with stable CAD and chronic HF. Recent studies have cast doubt on the safety of non-approved high doses of ivabradine for the treatment of patients with CAD and without clinical HF, but have shown no concerns on the doses approved for clinical use. Keywords: ivabradine, coronary artery disease, heart failure, angina pectoris, exercise performance

  9. [Current views on etiology, pathophysiology and clinical manifestations of acromegaly].

    Science.gov (United States)

    Krysiak, Robert; Okopień, Bogusław; Marek, Bogdan

    2012-02-01

    Acromegaly is a relatively rare disease caused by excess secretion of growth hormone, usually from a pituitary somatotrope adenoma. Most of the tumors causing acromegaly are sporadic but in some cases the disease results from the presence of an inherited endocrine syndrome including type 1 multiple endocrine neoplasia, McCune-Albright syndrome and Carney complex. Because of the slow evolution of signs and symptoms, acromegaly can be a diagnostic challenge. The disease is characterised by significantly increased morbidity and mortality, both of which are secondary to the involvement of multiple organ systems. This prompts the need for the rapid and accurate recognition and management of this disorder. Acromegaly is diagnosed on the basis of clinical picture, hormonal assays and radiologic imaging of the pituitary gland. This article reviews the etiology, histopathological picture, clinical features and current diagnostic strategies in acromegaly and prognosis in this disorder.

  10. [Asperger syndrome: evolution of the concept and current clinical data].

    Science.gov (United States)

    Aussilloux, C; Baghdadli, A

    2008-05-01

    Although Asperger syndrome is described by international classifications as a category of pervasive developmental disorder (PDD), its validity as a specific entity distinct from autistic disorders remains controversial. The syndrome, first described by Hans Asperger, could not be distinguished from high functioning autism (onset, symptoms, outcome...). However, international classifications propose a distinction between the two syndromes based on a delayed onset, the absence of speech delay, the presence of motor disorders and a better outcome in Asperger syndrome. This categorical differentiation is not confirmed by current studies and in the absence of biological markers, no clinical, neuropsychological or epidemiological criteria makes it possible to distinguish high functioning autism from Asperger syndrome. From a clinical perspective, it is nevertheless of interest to isolate Asperger syndrome from other autistic disorders to propose specific assessment and therapy.

  11. Efficacy and Safety of Saffron Supplementation: Current Clinical Findings.

    Science.gov (United States)

    Broadhead, G K; Chang, A; Grigg, J; McCluskey, P

    2016-12-09

    Saffron (Crocus savitus) is a Middle-Eastern herb with strong antioxidant properties. Its major constituents, safranal, crocin, and crocetin, are also antioxidants and bear structural similarities to other well-known natural antixodant substances, such as zeaxanthin. Given the role of oxidative stress in many diseases, considerable interest has been shown into the potential role of saffron supplementation as a treatment for a range of diseases. In vitro and animal studies have provided evidence that saffron and its constituents may be potent therapies for a range of pathologies, including Alzheimer's disease, age-related macular degeneration (AMD) and cardiac ischemia. Whether these findings translate into clinical efficacy, however, has as of yet been incompletely assessed. This makes assessing the role of saffron supplementation in these diseases difficult. Here, we review the current human clinical evidence supporting saffron supplementation as a treatment for a range of pathologies and the underlying science supporting its use.

  12. Clinical application of brain imaging for the diagnosis of mood disorders: the current state of play.

    Science.gov (United States)

    Savitz, J B; Rauch, S L; Drevets, W C

    2013-05-01

    In response to queries about whether brain imaging technology has reached the point where it is useful for making a clinical diagnosis and for helping to guide treatment selection, the American Psychiatric Association (APA) has recently written a position paper on the Clinical Application of Brain Imaging in Psychiatry. The following perspective piece is based on our contribution to this APA position paper, which specifically emphasized the application of neuroimaging in mood disorders. We present an introductory overview of the challenges faced by researchers in developing valid and reliable biomarkers for psychiatric disorders, followed by a synopsis of the extant neuroimaging findings in mood disorders, and an evidence-based review of the current research on brain imaging biomarkers in adult mood disorders. Although there are a number of promising results, by the standards proposed below, we argue that there are currently no brain imaging biomarkers that are clinically useful for establishing diagnosis or predicting treatment outcome in mood disorders.

  13. [Musculoskeletal shock wave therapy--current database of clinical research].

    Science.gov (United States)

    Rompe, J D; Buch, M; Gerdesmeyer, L; Haake, M; Loew, M; Maier, M; Heine, J

    2002-01-01

    During the past decade application of extracorporal shock waves became an established procedure for the treatment of various musculoskeletal diseases in Germany. Up to now the positive results of prospective randomised controlled trials have been published for the treatment of plantar fasciitis, lateral elbow epicondylitis (tennis elbow), and of calcifying tendinitis of the rotator cuff. Most recently, contradicting results of prospective randomised placebo-controlled trials with adequate sample size calculation have been reported. The goal of this review is to present information about the current clinical database on extracorporeal shock wave treatment (ESWT).

  14. Development of a current-controlled defibrillator for clinical tests.

    Science.gov (United States)

    Fischer, M; Schönegg, M; Schöchlin, J; Bolz, A

    2002-01-01

    The work presented here is only a part of the development for a new current-controlled defibrillator. In the diploma thesis "Development and construction of a current-controlled defibrillator for clinical tests" the most important part was the control and safety of the defibrillator. To ensure a safe circuit design, a risk-analysis and a Failure Mode and Effects Analysis (FMEA) were necessary. Another major part was the programming of a microcontroller in embedded C and a programmable logic device in Very High Speed Integrated Circuit Description Language (VHDL). The circuit had to be constructed, and the defibrillator was optically decoupled from the laptop for safety reasons. The waveform-data can be transmitted to the microcontroller from the laptop, and the logged data is then transmitted back.

  15. 466 Bee venom Immunotherapy with Standardized Extract, Two Case Comunication and Clinical Progress

    Science.gov (United States)

    Cardona, Aristoteles Alvarez; Nieto, Leticia Hernandez; Melendez, Alvaro Pedroza

    2012-01-01

    Background Bee venom immunotherapy is a safe and effective treatment, indicated in patients with previous history of severe systemic reactions to bee venom, demonstrating succesful desensitization in more than 90% of cases with standardized extract. Currently in Mexico there is no standardized extract commercially available for treatment, despite of having high activity of beekeeping and occupational exposure with at least 17,478 registered stings per year and an annually honey production of nearly 70 tons. Methods We present the clinical progress of 2 patients with history of severe systemic reactions to bee venom and occupational exposure, both with demonstrated sensitization by specific IgE and who underwent specific immunotherapy with standardized extract (Alk-US) reaching a maintenance weekly dose of 100 mcg (PLA2) for the last 4 years. Results Both patients sufered of accidental stings after reached the maintenance dose presenting mild local reactions to stings. Both patients had very different clinical course presenting a wide variety of adverse reactions during desensitization protocol; from mild local to generalized reactions all generally well tolerated allowed to reach the maintenance dose with succesful desensitization proved by accidental exposure without severe systemic reactions. Conclusions Bee venom specific immunotherapy with standardized extract is a well tolerated and efective treatment preventing the development of life threathening reactions in sensitized patients. It is important to promote the use and availability of standardized extract in developing countries with poor safety measures and high occupational exposure.

  16. CDISC 标准与中医药临床研究数据标准化%CDISC Standards and Clinical Research Data Standardization of Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    黎燕兰; 胡镜清; 刘保延

    2012-01-01

    临床研究数据标准化越来越受到关注,国际临床研究数据标准主要包括文件格式标准、分析标准、交换标准和术语标准4大类.其中交换标准和分析标准目前备受关注的是CDISC标准.数据管理质量和水平的落后已经成为制约国内临床试验持续、快速和健康发展的桎梏,如何应用国际临床数据标准缩小中医药临床研究与国际先进水平的差距是个不断探索的课题.本文简要就CDISC和其具体的两个标准以及在中医药临床研究数据标准化中的意义进行了较深入的描述和分析,并针对目前中医药临床研究数据全面运用CDISC标准存在的问题进行讨论,提出加强相关中医语义结构及术语标准研究是解决全面应用CIDSC标准问题的关键和必由之路.%More and more attention has been paid to the standardization of clinical research data. International clinical data standards mainly include four categories, which are file format, analysis standard, exchange standard and terminology standard. CDISC is the main criteria of exchange standard and analysis standard currently. Backwardness of quality and level of the data management has become one of the most important factors that affect the sustained, rapid and healthy development of domestic clinical trial. How to apply international standards of clinical data to narrow the gap of clinical research of Chinese medicine with the international advanced level is a topic which needs to be continuously explored. This paper firstly introduced the CDISC and its two standards, then analyzed the significance of data standardization in clinical research of traditional Chinese medicine (TCM), and finally discussed problems existed in the process of TCM clinical research using CDISC standards. It was suggested that the strengthening on research of relevant TCM semantic structure and its terminology standard is the key problem. The only way to solve this problem is to use the

  17. Strategies of bringing drug product marketing applications to meet current regulatory standards.

    Science.gov (United States)

    Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

    2015-08-01

    In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

  18. The use of psychometrists in clinical neuropsychology: history, current status, and future directions.

    Science.gov (United States)

    Malek-Ahmadi, Michael; Erickson, Tom; Puente, Antonio E; Pliskin, Neil; Rock, Rachel

    2012-01-01

    In recent years, the National Academy of Neuropsychology and other professional neuropsychological organizations have published a number of articles and position papers regarding the use, education, and training of psychometrists ("technicians"). Although these documents provide guidelines for the suggested qualifications and training procedures of psychometrists, none make any mention of the need for a standardized credentialing process, which is commonly required of technicians in similar fields, especially in medical settings. Given the recent changes in current procedural Terminology codes used to bill for neuropsychological services and the interpretation of legislation disallowing the use of psychometrists in New York, the need for a standard credential for psychometrists is apparent. This article will review the history and current use of psychometrists in clinical neuropsychology and highlight the need and rationale for the credentialing of psychometrists.

  19. Clinical Trial Design for HIV Prevention Research: Determining Standards of Prevention.

    Science.gov (United States)

    Dawson, Liza; Zwerski, Sheryl

    2015-06-01

    This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

  20. Endoscopic Ultrasound Elastography: Current Clinical Use in Pancreas.

    Science.gov (United States)

    Mondal, Utpal; Henkes, Nichole; Patel, Sandeep; Rosenkranz, Laura

    2016-08-01

    Elastography is a newer technique for the assessment of tissue elasticity using ultrasound. Cancerous tissue is known to be stiffer (hence, less elastic) than corresponding healthy tissue, and as a result, could be identified in an elasticity-based imaging. Ultrasound elastography has been used in the breast, thyroid, and cervix to differentiate malignant from benign neoplasms and to guide or avoid unnecessary biopsies. In the liver, elastography has enabled a noninvasive and reliable estimate of fibrosis. Endoscopic ultrasound has become a robust diagnostic and therapeutic tool for the management of pancreatic diseases. The addition of elastography to endoscopic ultrasound enabled further characterization of pancreas lesions, and several European and Asian studies have reported encouraging results. The current clinical role of endoscopic ultrasound elastography in the management of pancreas disorders and related literature are reviewed.

  1. Bacterial protein toxins: current and potential clinical use.

    Science.gov (United States)

    Fabbri, A; Travaglione, S; Falzano, L; Fiorentini, C

    2008-01-01

    Natural toxins are the product of a long-term evolution, and act on essential mechanisms in the most crucial and vital processes of living organisms. They can attack components of the protein synthesis machinery, actin polymerization, signal transduction pathways, intracellular trafficking of vesicles as well as immune and inflammatory responses. For this reason, toxins have increasingly being used as valuable tools for analysis of cellular physiology, and in the recent years, some of them are used medicinally for the treatment of human diseases. This review is devoted to protein toxins of bacterial origin, specifically those toxins that are currently used in therapy or those under study for their potential clinical applications. Bacterial protein toxins are all characterized by a specific mechanism of action that involves the central molecular pathways in the eukaryotic cell. Knowledge of their properties could be used for medical purposes.

  2. Curcumin: from ancient medicine to current clinical trials.

    Science.gov (United States)

    Hatcher, H; Planalp, R; Cho, J; Torti, F M; Torti, S V

    2008-06-01

    Curcumin is the active ingredient in the traditional herbal remedy and dietary spice turmeric (Curcuma longa). Curcumin has a surprisingly wide range of beneficial properties, including anti-inflammatory, antioxidant, chemopreventive and chemotherapeutic activity. The pleiotropic activities of curcumin derive from its complex chemistry as well as its ability to influence multiple signaling pathways, including survival pathways such as those regulated by NF-kappaB, Akt, and growth factors; cytoprotective pathways dependent on Nrf2; and metastatic and angiogenic pathways. Curcumin is a free radical scavenger and hydrogen donor, and exhibits both pro- and antioxidant activity. It also binds metals, particularly iron and copper, and can function as an iron chelator. Curcumin is remarkably non-toxic and exhibits limited bioavailability. Curcumin exhibits great promise as a therapeutic agent, and is currently in human clinical trials for a variety of conditions, including multiple myeloma, pancreatic cancer, myelodysplastic syndromes, colon cancer, psoriasis and Alzheimer's disease.

  3. Figures in clinical trial reports: current practice & scope for improvement

    Directory of Open Access Journals (Sweden)

    Travison Thomas G

    2007-11-01

    Full Text Available Abstract Background Most clinical trial publications include figures, but there is little guidance on what results should be displayed as figures and how. Purpose To evaluate the current use of figures in Trial reports, and to make constructive suggestions for future practice. Methods We surveyed all 77 reports of randomised controlled trials in five general medical journals during November 2006 to January 2007. The numbers and types of figures were determined, and then each Figure was assessed for its style, content, clarity and suitability. As a consequence, guidelines are developed for presenting figures, both in general and for each specific common type of Figure. Results Most trial reports contained one to three figures, mean 2.3 per article. The four main types were flow diagram, Kaplan Meier plot, Forest plot (for subgroup analyses and repeated measures over time: these accounted for 92% of all figures published. For each type of figure there is a considerable diversity of practice in both style and content which we illustrate with selected examples of both good and bad practice. Some pointers on what to do, and what to avoid, are derived from our critical evaluation of these articles' use of figures. Conclusion There is considerable scope for authors to improve their use of figures in clinical trial reports, as regards which figures to choose, their style of presentation and labelling, and their specific content. Particular improvements are needed for the four main types of figures commonly used.

  4. Overcoming resistance to targeted therapies in NSCLC: current approaches and clinical application.

    Science.gov (United States)

    Maione, Paolo; Sacco, Paola Claudia; Sgambato, Assunta; Casaluce, Francesca; Rossi, Antonio; Gridelli, Cesare

    2015-09-01

    The discovery that a number of aberrant tumorigenic processes and signal transduction pathways are mediated by druggable protein kinases has led to a revolutionary change in nonsmall cell lung cancer (NSCLC) treatment. Epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) are the targets of several tyrosine kinase inhibitors (TKIs), some of them approved for treatment and others currently in clinical development. First-generation agents offer, in target populations, a substantial improvement of outcomes compared with standard chemotherapy in the treatment of advanced NSCLC. Unfortunately, drug resistance develops after initial benefit through a variety of mechanisms. Novel generation EGFR and ALK inhibitors are currently in advanced clinical development and are producing encouraging results in patients with acquired resistance to previous generation agents. The search for new drugs or strategies to overcome the TKI resistance in patients with EGFR mutations or ALK rearrangements is to be considered a priority for the improvement of outcomes in the treatment of advanced NSCLC.

  5. Current standards of neuropsychological assessment in epilepsy surgery centers across Europe.

    Science.gov (United States)

    Vogt, Viola Lara; Äikiä, Marja; Del Barrio, Antonio; Boon, Paul; Borbély, Csaba; Bran, Ema; Braun, Kees; Carette, Evelien; Clark, Maria; Cross, Judith Helen; Dimova, Petia; Fabo, Daniel; Foroglou, Nikolaos; Francione, Stefano; Gersamia, Anna; Gil-Nagel, Antonio; Guekht, Alla; Harrison, Sue; Hecimovic, Hrvoje; Heminghyt, Einar; Hirsch, Edouard; Javurkova, Alena; Kälviäinen, Reetta; Kavan, Nicole; Kelemen, Anna; Kimiskidis, Vasilios K; Kirschner, Margarita; Kleitz, Catherine; Kobulashvili, Teia; Kosmidis, Mary H; Kurtish, Selin Yagci; Lesourd, Mathieu; Ljunggren, Sofia; Lossius, Morten Ingvar; Malmgren, Kristina; Mameniskiené, Ruta; Martin-Sanfilippo, Patricia; Marusic, Petr; Miatton, Marijke; Özkara, Çiğdem; Pelle, Federica; Rubboli, Guido; Rudebeck, Sarah; Ryvlin, Philippe; van Schooneveld, Monique; Schmid, Elisabeth; Schmidt, Pia-Magdalena; Seeck, Margitta; Steinhoff, Bernhard J; Shavel-Jessop, Sara; Tarta-Arsene, Oana; Trinka, Eugen; Viggedal, Gerd; Wendling, Anne-Sophie; Witt, Juri-Alexander; Helmstaedter, Christoph

    2017-03-01

    We explored the current practice with respect to the neuropsychological assessment of surgical epilepsy patients in European epilepsy centers, with the aim of harmonizing and establishing common standards. Twenty-six epilepsy centers and members of "E-PILEPSY" (a European pilot network of reference centers in refractory epilepsy and epilepsy surgery), were asked to report the status of neuropsychological assessment in adults and children via two different surveys. There was a consensus among these centers regarding the role of neuropsychology in the presurgical workup. Strong agreement was found on indications (localization, epileptic dysfunctions, adverse drugs effects, and postoperative monitoring) and the domains to be evaluated (memory, attention, executive functions, language, visuospatial skills, intelligence, depression, anxiety, and quality of life). Although 186 different tests are in use throughout these European centers, a core group of tests reflecting a moderate level of agreement could be discerned. Variability exists with regard to indications, protocols, and paradigms for the assessment of hemispheric language dominance. For the tests in use, little published evidence of clinical validity in epilepsy was provided. Participants in the survey reported a need for improvement concerning the validity of the tests, tools for the assessment of everyday functioning and accelerated forgetting, national norms, and test co-normalization. Based on the present survey, we documented a consensus regarding the indications and principles of neuropsychological testing. Despite the variety of tests in use, the survey indicated that there may be a core set of tests chosen based on experience, as well as on published evidence. By combining these findings with the results of an ongoing systematic literature review, we aim for a battery that can be recommended for the use across epilepsy surgical centers in Europe. Wiley Periodicals, Inc. © 2017 International League

  6. Standardized Clinical Assessment And Management Plans (SCAMPs) Provide A Better Alternative To Clinical Practice Guidelines

    Science.gov (United States)

    Farias, Michael; Jenkins, Kathy; Lock, James; Rathod, Rahul; Newburger, Jane; Bates, David W.; Safran, Dana G.; Friedman, Kevin; Greenberg, Josh

    2014-01-01

    Variability in medical practice in the United States leads to higher costs without achieving better patient outcomes. Clinical practice guidelines, which are intended to reduce variation and improve care, have several drawbacks that limit the extent of buy-in by clinicians. In contrast, standardized clinical assessment and management plans (SCAMPs) offer a clinician-designed approach to promoting care standardization that accommodates patients’ individual differences, respects providers’ clinical acumen, and keeps pace with the rapid growth of medical knowledge. Since early 2009 more than 12,000 patients have been enrolled in forty-nine SCAMPs in nine states and Washington, D.C. In one example, a SCAMP was credited with increasing clinicians’ rate of compliance with a recommended specialist referral for children from 19.6 percent to 75 percent. In another example, SCAMPs were associated with an 11–51 percent decrease in total medical expenses for six conditions when compared with a historical cohort. Innovative tools such as SCAMPs should be carefully examined by policy makers searching for methods to promote the delivery of high-quality, cost-effective care. PMID:23650325

  7. Experimental and clinical standards, and evolution of lasers in neurosurgery.

    Science.gov (United States)

    Devaux, B C; Roux, F X

    1996-01-01

    From initial experiments of ruby, argon and CO2 lasers on the nervous system so far, dramatic progress was made in delivery systems technology as well as in knowledge of laser-tissue interaction effects and hazards through various animal experiments and clinical experience. Most surgical effects of laser light on neural tissue and the central nervous system (CNS) are thermal lesions. Haemostasis, cutting and vaporization depend on laser emission parameters--wavelength, fluence and mode--and on the exposed tissues optical and thermal properties--water and haemoglobin content, thermal conductivity and specific heat. CO2 and Nd-YAG lasers have today a large place in the neurosurgical armamentarium, while new laser sources such as high power diode lasers will have one in the near future. Current applications of these lasers derive from their respective characteristics, and include CNS tumour and vascular malformation surgery, and stereotactic neurosurgery. Intracranial, spinal cord and intra-orbital meningiomas are the best lesions for laser use for haemostasis, dissection and tissue vaporization. Resection of acoustic neuromas, pituitary tumours, spinal cord neuromas, intracerebral gliomas and metastases may also benefit from lasers as accurate, haemostatic, non-contact instruments which reduce surgical trauma to the brain and eloquent structures such as brain stem and cranial nerves. Coagulative lasers (1.06 microns and 1.32 microns Nd-YAG, argon, or diode laser) will find an application for arteriovenous malformations and cavernomas. Any fiberoptic-guided laser will find a use during stereotactic neurosurgical procedures, including image-guided resection of tumours and vascular malformations and endoscopic tumour resection and cysts or entry into a ventricle. Besides these routine applications of lasers, laser interstitial thermotherapy (LITT) and photodynamic therapy (PDT) of brain tumours are still in the experimental stage. The choice of a laser in a

  8. Electric current in flares ribbons: from the standard model in 3D to observations

    CERN Document Server

    Janvier, Miho; Bommier, V; Schmieder, B; Démoulin, P; Pariat, E

    2014-01-01

    The paper presents for the first time a quantification of the photospheric electric current ribbon evolutions during an eruptive flare, accurately predicted by the standard 3D flare model. The standard flare model in 3D has been developed with the MHD code OHM, which models the evolution of an unstable flux rope. Through a series of paper, the model has been successful in explaining observational characteristics of eruptive flares, as well as the intrinsic 3D reconnection mechanism. Such a model also explains the increase of the photospheric currents as a consequence of the evolution of the coronal current layer where reconnection takes place. The photospheric footprints of the 3D current layer reveal a ribbon shape structure. In the present paper, the evolution of the current density is analyzed for the X-class flare that occurred on 15/02/2011 in AR 11158. We first describe the structural evolution of the high vertical current density regions derived with the UNNOFIT inversion code from magnetograms (HMI, e...

  9. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

    DEFF Research Database (Denmark)

    Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio

    2007-01-01

    OBJECTIVE: To conduct a cross-sectional review of non-selected consecutive outpatients with rheumatoid arthritis (RA) as part of standard clinical care in 15 countries for an overview of the characteristics of patients with RA. METHODS: The review included current disease activity using data from...

  10. Standardized clinical outcome rating scale for depression for use in clinical practice.

    Science.gov (United States)

    Zimmerman, Mark; Posternak, Michael A; Chelminski, Iwona; Friedman, Michael

    2005-01-01

    The integration of research into clinical practice to conduct effectiveness studies faces multiple obstacles. One obstacle is the burden of completing research measures of outcome. A simple, reliable, and valid measure that could be rated at every visit, incorporated into a clinician's progress note, and reflect the DSM-IV definition of a major depressive episode (including partial and full remission from the episode) would enhance the ability to conduct effectiveness research. The goal of the present study was to examine the reliability and validity of such a measure. Three hundred and three psychiatric outpatients who were being treated for a DSM-IV major depressive episode were rated on the Standardized Clinical Outcome Rating for Depression (SCOR-D), 17-item Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, and the Global Assessment of Functioning. We examined the correlation between the SCOR-D and the other measures, and conducted an analyses of variance to compare mean values on these measures for each rating point on the SCOR-D. The inter-rater reliability of the SCOR-D dimensional ratings and categorical determination of remission were high. The SCOR-D was highly correlated with the other scales, and there were significant differences on the other measures of depression severity between each adjacent rating level of the SCOR-D. The SCOR-D is a brief standardized outcome measure linked to the DSM-IV approach toward defining remission that can be incorporated into routine clinical practice without adding undue burden to the treating clinician with some evidence of reliability and validity. This measure could make it more feasible to conduct effectiveness studies in clinical practice.

  11. submitter Flavour-changing neutral currents making and breaking the standard model

    CERN Document Server

    Archilli, F; Owen, P; Petridis, K A

    2017-01-01

    The standard model of particle physics is our best description yet of fundamental particles and their interactions, but it is known to be incomplete. As yet undiscovered particles and interactions might exist. One of the most powerful ways to search for new particles is by studying processes known as flavour-changing neutral current decays, whereby a quark changes its flavour without altering its electric charge. One example of such a transition is the decay of a beauty quark into a strange quark. Here we review some intriguing anomalies in these decays, which have revealed potential cracks in the standard model—hinting at the existence of new phenomena.

  12. Telecytology: Clinical applications, current challenges, and future benefits

    Directory of Open Access Journals (Sweden)

    Michael Thrall

    2011-01-01

    Full Text Available Telecytology is the interpretation of cytology material at a distance using digital images. For more than a decade, pioneering efforts to introduce telecytology into clinical practice have been reported. A Medline search for "telecytology" and "cytology" reveals a voluminous literature, though much of what has been published to date is based on technologies that are rapidly becoming obsolete. The technological limitations of previous techniques, including the transmission of static digital images and dynamic streaming images, have limited telecytology to minor niches. The primary problem with these technologies is that the remote viewer can only see a small fraction of the material on the original slides, introducing the possibility of diagnostic error based not only on image quality but also on image selection. Remote robotic microscopy offers one possible solution to this problem, but to date has found limited acceptance, principally attributable to slow operating times. Whole slide imaging seems to be a much more promising solution, though cytology-specific literature regarding its use is still scant. The advent of whole slide imaging opens up new possibilities for telecytology by enabling high-quality images of entire cytology specimens to be available to anyone, anywhere via the Internet. Although challenges remain, especially with regard to capturing the full microscopy experience including multiple planes of focus and sharp high-powered images, rapidly advancing technology promises to overcome these limitations. Increasing application of whole slide imaging technology in surgical pathology will undoubtedly also increase its application to cytology due to the increasing affordability and practicality of the equipment as it serves a larger number of useful roles within a pathology department. The current and expanding applications of telecytology for clinical practice, education, quality assurance, and testing will be reviewed.

  13. Current Clinical Indications for Small Bowel Capsule Endoscopy.

    Science.gov (United States)

    Rosa, Bruno; Cotter, José

    2015-01-01

    Small bowel capsule endoscopy is currently the first line diagnostic examination for many diseases affecting the small bowel. This article aims to review and critically address the current indications of small bowel capsule endoscopy in clinical practice. Bibliographic review of relevant and recent papers indexed in PubMed. Small bowel capsule endoscopy enables a non-invasive full-assessment of the small bowel mucosa, with high diagnostic yield even for subtle lesions. In patients with obscure gastrointestinal bleeding, diagnostic yield is higher when performed early after the onset of bleeding. Endoscopic treatment of angioectasias using balloon-assisted enteroscopy may contribute to reduce rebleeding, while the risk of rebleeding in patients with 'negative' small bowel capsule endoscopy is debatable. Cross-sectional imaging may be more accurate than small bowel capsule endoscopy for the diagnosis of large small bowel tumors. The Smooth Protruding Index on Capsule Endoscopy (SPICE score) may help to differentiate submucosal tumors from innocent bulges. Small bowel capsule endoscopy is also a key diagnostic instrument in patients with suspected Crohn's disease and non-diagnostic ileocolonoscopy; it may also influence prognosis and therapeutic management, by determining disease extent and activity in patients with known Crohn's disease. The role of small bowel capsule endoscopy to investigate possible complications in patients with non-responsive coeliac disease is evolving. Small bowel capsule endoscopy is a valuable diagnostic instrument for patients with obscure gastrointestinal bleeding and/or suspected small bowel tumors; it may also be a key examination in patients with suspected Crohn's disease, or patients with known Crohn's disease to fully assess disease extension and activity; finally, it may contribute for the diagnosis of complications of non-responsive coeliac disease.

  14. Novel femoral artery terminology: integrating anatomy and clinical procedures leading to standardized intuitive nomenclature.

    Science.gov (United States)

    Benninger, Brion

    2014-10-01

    The objective of this study is to investigate the terminology of the femoral artery and recommended alternative terminology that satisfies both anatomy and clinical arenas.The femoral artery (FA) is often defined as the continuation of the external iliac artery. Specifically, when the external iliac artery reaches directly beneath the inguinal ligament, it becomes the FA. Currently, Terminologia Anatomica (TA) records the profunda femoris or deep femoral as a terminal branch. Clinicians often use superficial femoral artery (SFA) rather than FA and profunda or deep FA. SFA is actually very deep and well protected for most of its journey. On observation, the terminology in current use is not intuitive. The objective of this study was to investigate the terminology associated with the anatomical and clinical anatomical interpretations of the FA and its terminal branches and to suggest a more appropriate terminology that addresses the points of view of the macro anatomist, as well as that of the clinician. Literature search was conducted regarding the nomenclature of the FA and its terminal branches. Dissection of 89 embalmed cadavers (49F, 40M, ages 47-89) was conducted to analyze the morphology of the FA and its branches. Perusal of the literature revealed a difference in terminology between anatomical and clinical textbooks/atlases/journals regarding the FA and its terminal branch. Our dissections suggested that the FA may be better defined vis-à-vis its relationship to the anterior and posterior compartments of the thigh. A difference in terminology exists between the anatomical and clinical arenas. A need for a standardized terminology is necessary because clinicians and their publishers have not adopted TA. This study suggests that the current FA be considered the common FA and the continuation of the FA, the SFA be renamed the anterior FA and the current profunda (the deep FA) be renamed the posterior FA, respectively. The proposed terminology mirrors the lower

  15. Current Perspectives on Desmoid Tumors: The Mayo Clinic Approach

    Directory of Open Access Journals (Sweden)

    Scott Okuno

    2011-08-01

    Full Text Available Desmoid tumors are a rare group of locally aggressive, non malignant tumors of fibroblastic origin that can lead to significant morbidity due to local invasion. Despite advances in the understanding of these tumors, their natural history is incompletely understood and the optimal treatment is still a matter of debate. Local control is the main goal of treatment and there has been a change in philosophy regarding the management of these tumors from aggressive surgical resection to function preservation. A multidisciplinary approach is essential to plan local control with acceptable morbidity. The current Mayo Clinic algorithm for the treatment of these tumors is based on institutional experience and the available evidence in the literature: asymptomatic/non progressive lesions away from vital structures are managed with observation and regular imaging; primary or recurrent desmoid tumors which are symptomatic or progressive or near vital structures are managed with wide surgical resection when wide surgical margins are possible with minimal functional and cosmetic loss. When positive or close surgical margins are likely, surgical resection with adjuvant radiotherapy or definitive radiotherapy is preferred. If likely functional or cosmetic deficit is unacceptable, radiotherapy is the treatment of choice. Unresectable lesions are considered for radiotherapy, chemotherapy or newer modalities however an unresectable lesion associated with a painful, functionless, infected extremity is managed with an amputation.

  16. Clinical proteomics: Current status, challenges, and future perspectives

    Directory of Open Access Journals (Sweden)

    Shyh-Horng Chiou

    2011-01-01

    Full Text Available This account will give an overview and evaluation of the current advances in mass spectrometry (MS-based proteomics platforms and technology. A general review of some background information concerning the application of these methods in the characterization of molecular sizes and related protein expression profiles associated with different types of cells under varied experimental conditions will be presented. It is intended to provide a concise and succinct overview to those clinical researchers first exposed to this foremost powerful methodology in modern life sciences of postgenomic era. Proteomic characterization using highly sophisticated and expensive instrumentation of MS has been used to characterize biological samples of complex protein mixtures with vastly different protein structure and composition. These systems are then used to highlight the versatility and potential of the MS-based proteomic strategies for facilitating protein expression analysis of various disease-related organisms or tissues of interest. Major MS-based strategies reviewed herein include (1 matrix-assisted laser desorption ionization-MS and electron-spray ionization proteomics; (2 one-dimensional or two-dimensional gel-based proteomics; (3 gel-free shotgun proteomics in conjunction with liquid chromatography/tandem MS; (4 Multiple reaction monitoring coupled tandem MS quantitative proteomics and; (5 Phosphoproteomics based on immobilized metal affinity chromatography and liquid chromatography-MS/MS.

  17. Current Evidence on Atypical Odontalgia: Diagnosis and Clinical Management

    Directory of Open Access Journals (Sweden)

    Yoshihiro Abiko

    2012-01-01

    Full Text Available Patients with atypical odontalgia (AO complain of medically unexplained toothache. No evidence-based diagnostic criteria or treatment guidelines are yet available. The present paper addresses seven clinical questions about AO based on current knowledge in the literature and discusses diagnostic criteria and guidelines for treatment and management. The questions are (i What is the prevalence of AO in the community?\t(ii What psychological problems are experienced by patients with AO? (iii Are there any comorbidities of AO? (iv Is local anesthesia effective for the relief of pain in AO? (v Are there any characteristic symptoms of AO other than spontaneous pain? (vi Are antidepressants effective for treatment of AO? (vii Are anticonvulsants effective for treatment of AO? Our literature search provided answers for these questions; however, there is insufficient evidence-based data to establish guidelines for the diagnosis and treatment of AO. Overall, some diagnostic criteria for neuropathic pain and persistent dentoalveolar pain disorder may be applied to AO patients. The patient's psychogenic background should always be considered in the treatment and/or management of AO. The clinicians may need to treat AO patients using Patient-Oriented Evidence that Matters approach.

  18. Current Evidence on Atypical Odontalgia: Diagnosis and Clinical Management

    Science.gov (United States)

    Abiko, Yoshihiro; Matsuoka, Hirofumi; Chiba, Itsuo; Toyofuku, Akira

    2012-01-01

    Patients with atypical odontalgia (AO) complain of medically unexplained toothache. No evidence-based diagnostic criteria or treatment guidelines are yet available. The present paper addresses seven clinical questions about AO based on current knowledge in the literature and discusses diagnostic criteria and guidelines for treatment and management. The questions are (i) What is the prevalence of AO in the community? (ii) What psychological problems are experienced by patients with AO? (iii) Are there any comorbidities of AO? (iv) Is local anesthesia effective for the relief of pain in AO? (v) Are there any characteristic symptoms of AO other than spontaneous pain? (vi) Are antidepressants effective for treatment of AO? (vii) Are anticonvulsants effective for treatment of AO? Our literature search provided answers for these questions; however, there is insufficient evidence-based data to establish guidelines for the diagnosis and treatment of AO. Overall, some diagnostic criteria for neuropathic pain and persistent dentoalveolar pain disorder may be applied to AO patients. The patient's psychogenic background should always be considered in the treatment and/or management of AO. The clinicians may need to treat AO patients using Patient-Oriented Evidence that Matters approach. PMID:22844283

  19. Current Perspectives on Desmoid Tumors: The Mayo Clinic Approach

    Energy Technology Data Exchange (ETDEWEB)

    Joglekar, Siddharth B. [Musculoskeletal Oncology, Mayo Clinic, Rochester, MN55905 (United States); Rose, Peter S.; Sim, Franklin, E-mail: sim.franklin@mayo.edu [Department of Orthopedics, Mayo Clinic, 200 1st ST SW, Rochester, MN 55905 (United States); Okuno, Scott [Department of Oncology, Mayo Clinic, Rochester, MN55905 (United States); Petersen, Ivy [Department of Radiation Oncology, Mayo Clinic, Rochester, MN55905 (United States)

    2011-08-08

    Desmoid tumors are a rare group of locally aggressive, non malignant tumors of fibroblastic origin that can lead to significant morbidity due to local invasion. Despite advances in the understanding of these tumors, their natural history is incompletely understood and the optimal treatment is still a matter of debate. Local control is the main goal of treatment and there has been a change in philosophy regarding the management of these tumors from aggressive surgical resection to function preservation. A multidisciplinary approach is essential to plan local control with acceptable morbidity. The current Mayo Clinic algorithm for the treatment of these tumors is based on institutional experience and the available evidence in the literature: asymptomatic/non progressive lesions away from vital structures are managed with observation and regular imaging; primary or recurrent desmoid tumors which are symptomatic or progressive or near vital structures are managed with wide surgical resection when wide surgical margins are possible with minimal functional and cosmetic loss. When positive or close surgical margins are likely, surgical resection with adjuvant radiotherapy or definitive radiotherapy is preferred. If likely functional or cosmetic deficit is unacceptable, radiotherapy is the treatment of choice. Unresectable lesions are considered for radiotherapy, chemotherapy or newer modalities however an unresectable lesion associated with a painful, functionless, infected extremity is managed with an amputation.

  20. SAPHO Syndrome: Current Developments and Approaches to Clinical Treatment.

    Science.gov (United States)

    Firinu, Davide; Garcia-Larsen, Vanessa; Manconi, Paolo Emilio; Del Giacco, Stefano R

    2016-06-01

    SAPHO syndrome (synovitis, acne, pustulosis, hyperostosis, and osteitis) is a rare autoimmune disease which, due to its clinical presentation and symptoms, is often misdiagnosed and unrecognized. Its main features are prominent inflammatory cutaneous and articular manifestations. Treatments with immunosuppressive drugs have been used for the management of SAPHO with variable results. To date, the use of anti-TNF-α agents has proved to be an effective alternative to conventional treatment for unresponsive or refractory SAPHO cases. TNF-α is a pro-inflammatory cytokine and pivotal regulator of other cytokines, including IL-1 β, IL-6, and IL-8, involved in inflammation, acute-phase response induction, and chemotaxis. IL-1 inhibition strategies with anakinra have shown efficacy as first and second lines of treatment. In this review, we will describe the main characteristics of biological drugs currently used for SAPHO syndrome. We also describe some of the promising therapeutic effects of ustekinumab, an antibody against the p40 subunit of IL-12 and IL-23, after failure of multiple drugs including anti-TNF-α and anakinra. We discuss the use and impact of the new anti-IL-1 antagonists involved in the IL-17 blockade, in particular for the most difficult-to-treat SAPHO cases.

  1. American Dietetic Association's Standardized Nutrition Language: Project logic model and current status.

    Science.gov (United States)

    Jenkins, Melinda; Myers, Esther; Charney, Pam; Escott-Stump, Sylvia

    2006-01-01

    Standardized terminology and digital sources of evidence are essential for evidence-based practice. Dieticians desire concise and consistent documentation of nutrition diagnoses, interventions and outcomes that will be fit for electronic health records. Building on more than 5 years of work to generate the Nutrition Care Process and Model as a road map to quality nutrition care and outcomes, and recognizing existing standardized languages serving other health professions, a task force of the American Dietetic Association (ADA) has begun to develop and disseminate standardized nutrition language. This paper will describe the group's working logic model, the Nutrition Care Process, and the current status of the nutrition language with comparisons to nursing process and terminology.

  2. HYPOPARATHYROIDISM: ETIOLOGY, CLINICAL MANIFESTATION, CURRENT DIAGNOSTICS AND TREATMENT

    Directory of Open Access Journals (Sweden)

    N. G. Mokrysheva

    2016-01-01

    Full Text Available Parathyroid hormone (PTH is the main regulator of calcium and phosphorus metabolism. PTH deficiency or tissue resistance to its effects results in hypoparathyroidism characterized by low serum calcium and elevated serum phosphate levels. The most common is post-operative hypoparathyroidism caused by an inadvertent damage or removal of the parathyroid glands, deterioration of blood supply to the neck region, most often during thyroid surgery. The second common form of the disease is the autoimmune one related with immune destruction of parathyroid cells. Less frequent causes of hypoparathyroidism include a variety of genetic syndromes, mitochondrial genome defects, and hypomagnesemia. The main signs and symptoms of hypoparathyroidism are related to hypocalcaemia and hyperphosphatemia land result in increased neuromuscular irritability and general autonomic reactivity, with finger and toe tingling, muscle cramps, tonic seizures, laryngo- and bronchospasm, and neurosis. These symptoms are closely associated with serum calcium levels; their severity depends on the degree of hypocalcaemia. Laboratory parameters confirming the diagnosis of hypoparathyroidism are hypocalcaemia, hyperphosphatemia, and reduced serum PTH. Treatment of hypoparathyroidism involves management of hypocalcaemic crisis and maintenance therapy. Acute hypocalcaemia, a  potentially life-threatening condition, is treated as an emergency with intravenous calcium combined with oral calcium and active vitamin D. Standard chronic treatment for hypoparathyroidism is based on oral calcium and active metabolites of vitamin  D / vitamin  D analogs and is aimed at the balance between optimal low-normal serum calcium concentrations and normocalciuria. Worsening hypercalciuria is often underestimated by specialists, although it can cause severe renal problems, such as nephrocalcinosis and neprolithiasis. Hypoparathyroidism is one of the few endocrine deficiencies for which replacement

  3. Guidelines for Standard Photography in Gross and Clinical Anatomy

    Science.gov (United States)

    Barut, Cagatay; Ertilav, Hakan

    2011-01-01

    Photography has a widespread usage in medicine and anatomy. In this review, authors focused on the usage of photography in gross and clinical anatomy. Photography in gross and clinical anatomy is not only essential for accurate documentation of morphological findings but also important in sharing knowledge and experience. Photographs of cadavers…

  4. Guidelines for Standard Photography in Gross and Clinical Anatomy

    Science.gov (United States)

    Barut, Cagatay; Ertilav, Hakan

    2011-01-01

    Photography has a widespread usage in medicine and anatomy. In this review, authors focused on the usage of photography in gross and clinical anatomy. Photography in gross and clinical anatomy is not only essential for accurate documentation of morphological findings but also important in sharing knowledge and experience. Photographs of cadavers…

  5. Current State of Clinical Studies on Diagnosis and Treatment of Sudden Deafness in China

    Institute of Scientific and Technical Information of China (English)

    YU Yaping; YANG Shiming; GUO Wei; YANG Weiyan; GU Rui

    2006-01-01

    Objective To evaluate the current status of clinical studies on diagnosis and treatment of sudden deafness (SD) in China by retrospective reviewing articles on SD published in Chinese journals in the past 5 years.Special attention is given to whether the diagnosis and treatment standards established in 1996 by the otolaryngology branch of Chinese Medical Association (the"1996 standard") were followed. Methods The terms of "Sudden deafness" and "treatment" were used as the keywords in searching articles published between 2000 and 2004 in the Chinese biomedicine literature database and Chinese journal network. Principles of evidence-based medicine were applied in reviewing the articles. Results Two hundreds and thirty- four articles were identified, including 176 between 2000 and 2002 and 58 between 2003 and 2004. Among the 176 articles published between 2000 and 2002,effects of medications were studies in 126 articles, of which only 26 (20.6%) followed the"1996 standards".Eighty-nine (70.6%) were reported based on controlled clinical trials (CCT) and 36 (28.5%) met the criteria of randomized controlled trails (RCT). Of the 58 articles published between 2003 and 2004, drug effects were evaluated in 25 articles, which were all based on the "1996 standards". However, there lacked placebo control, follow-up data or statistical analysis in these papers. Only 6 articles reported side-effects from pharmacological treatment. Conclusions While a significant number of articles on SD were published in the past 5 years, the "1996 standards" were followed only in a small number of them. The standards may not be appropriate in guiding research and need to be modified for improved guidance to SD management. Multi-center, RCTs should be a crucial part in studies on SD.

  6. Clinical data management: Current status, challenges, and future directions from industry perspectives

    Directory of Open Access Journals (Sweden)

    Zhengwu Lu

    2010-06-01

    Full Text Available Zhengwu Lu1, Jing Su21Smith Hanley Consulting, Houston, Texas; 2Department of Chemical Engineering, University of Massachusetts, Amherst, MA, USAAbstract: To maintain a competitive position, the biopharmaceutical industry has been facing the challenge of increasing productivity both internally and externally. As the product of the clinical development process, clinical data are recognized to be the key corporate asset and provide critical evidence of a medicine’s efficacy and safety and of its potential economic value to the market. It is also well recognized that using effective technology-enabled methods to manage clinical data can enhance the speed with which the drug is developed and commercialized, hence enhancing the competitive advantage. The effective use of data-capture tools may ensure that high-quality data are available for early review and rapid decision-making. A well-designed, protocol-driven, standardized, site workflow-oriented and documented database, populated via efficient data feed mechanisms, will ensure regulatory and commercial questions receive rapid responses. When information from a sponsor’s clinical database or data warehouse develops into corporate knowledge, the value of the medicine can be realized. Moreover, regulators, payer groups, patients, activist groups, patient advocacy groups, and employers are becoming more educated consumers of medicine, requiring monetary value and quality, and seeking out up-todate medical information supplied by biopharmaceutical companies. All these developments in the current biopharmaceutical arena demand that clinical data management (CDM is at the forefront, leading change, influencing direction, and providing objective evidence. Sustaining an integrated database or data repository for initial product registration and subsequent postmarketing uses is a long-term process to maximize return on investment for organizations. CDM should be the owner of driving clinical data

  7. Current applications and future directions for the CDISC Operational Data Model standard: A methodological review.

    Science.gov (United States)

    Hume, Sam; Aerts, Jozef; Sarnikar, Surendra; Huser, Vojtech

    2016-04-01

    In order to further advance research and development on the Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) standard, the existing research must be well understood. This paper presents a methodological review of the ODM literature. Specifically, it develops a classification schema to categorize the ODM literature according to how the standard has been applied within the clinical research data lifecycle. This paper suggests areas for future research and development that address ODM's limitations and capitalize on its strengths to support new trends in clinical research informatics. A systematic scan of the following databases was performed: (1) ABI/Inform, (2) ACM Digital, (3) AIS eLibrary, (4) Europe Central PubMed, (5) Google Scholar, (5) IEEE Xplore, (7) PubMed, and (8) ScienceDirect. A Web of Science citation analysis was also performed. The search term used on all databases was "CDISC ODM." The two primary inclusion criteria were: (1) the research must examine the use of ODM as an information system solution component, or (2) the research must critically evaluate ODM against a stated solution usage scenario. Out of 2686 articles identified, 266 were included in a title level review, resulting in 183 articles. An abstract review followed, resulting in 121 remaining articles; and after a full text scan 69 articles met the inclusion criteria. As the demand for interoperability has increased, ODM has shown remarkable flexibility and has been extended to cover a broad range of data and metadata requirements that reach well beyond ODM's original use cases. This flexibility has yielded research literature that covers a diverse array of topic areas. A classification schema reflecting the use of ODM within the clinical research data lifecycle was created to provide a categorized and consolidated view of the ODM literature. The elements of the framework include: (1) EDC (Electronic Data Capture) and EHR (Electronic Health Record

  8. Currently Clinical Views on Genetics of Wilson′s Disease

    Directory of Open Access Journals (Sweden)

    Chen Chen

    2015-01-01

    Conclusions: Clinical genetics studies are necessary to understand the mechanism underlying WD at the molecular level from the genotype to the phenotype. Clinical genetics research benefits newly emerging medical treatments including stem cell transplantation and gene therapy for WD patients.

  9. Pediatric Clinical Trials: Current Scenario in the Asia Pacific Region

    Directory of Open Access Journals (Sweden)

    Saldanha LM

    2013-07-01

    Full Text Available Lisa Marie Saldanha,1 Saumya Nayak,1 Adeline Sng,1 Mei-Ling Long,1 Elisabeth Schrader,2 Amanur Rahman,3 Elvira Zenaida Lansang,1 Karen Wai,1 Ken Lee41Feasibility and Site Identification Asia, Quintiles East Asia Private Limited, Singapore; 2Quintiles Pediatric Center of Excellence, Durham, NC, USA; 3Faculty of Engineering, National University of Singapore, Singapore; 4Asia Site Services, Quintiles East Asia Private Limited, SingaporeObjective: This site survey was conducted to understand the current pediatric clinical trial landscape across countries in the Asia Pacific region, specifically in terms of interest, experience, capabilities, requirements of the ethics committee, patient availability, and overall challenges involved in conducting pediatric trials.Methods and materials: Between May and June 2012, an English language survey form was sent to sites (identified through Quintiles’ internal database with pediatric capability and referrals from doctors during a preliminary outreach. In July 2012, the responses from the completed survey forms were entered into SurveyMethods, a web-based central repository. Data analysis was performed in August–September 2012 using SurveyMethods.Results: Seventy-seven sites were contacted for this survey across the Asia Pacific region. Sixty-four percent (49 sites completed 63 surveys and confirmed interest to participate in clinical trials in the pediatric population. Seventy-one percent of the sites had prior experience. Eighty percent confirmed needing an assent from pediatric patients; 81%–95% confirmed acceptance of placebo-controlled and pharmacokinetic studies by ethics committees; and 37% cited challenges in conducting studies in this population.Conclusion: This survey indicates that there is a high level of interest among sites in the Asia Pacific region in conducting pediatric trials across various therapeutic indications. No major insurmountable challenges were identified in conducting

  10. Can context justify an ethical double standard for clinical research in developing countries?

    Directory of Open Access Journals (Sweden)

    Landes Megan

    2005-07-01

    Full Text Available Abstract Background The design of clinical research deserves special caution so as to safeguard the rights of participating individuals. While the international community has agreed on ethical standards for the design of research, these frameworks still remain open to interpretation, revision and debate. Recently a breach in the consensus of how to apply these ethical standards to research in developing countries has occurred, notably beginning with the 1994 placebo-controlled trials to reduce maternal to child transmission of HIV-1 in Africa, Asia and the Caribbean. The design of these trials sparked intense debate with the inclusion of a placebo-control group despite the existence of a 'gold standard' and trial supporters grounded their justifications of the trial design on the context of scarcity in resource-poor settings. Discussion These 'contextual' apologetics are arguably an ethical loophole inherent in current bioethical methodology. However, this convenient appropriation of 'contextual' analysis simply fails to acknowledge the underpinnings of feminist ethical analysis upon which it must stand. A more rigorous analysis of the political, social, and economic structures pertaining to the global context of developing countries reveals that the bioethical principles of beneficence and justice fail to be met in this trial design. Conclusion Within this broader, and theoretically necessary, understanding of context, it becomes impossible to justify an ethical double standard for research in developing countries.

  11. Trust in standards: transitioning clinical exome sequencing from bench to bedside.

    Science.gov (United States)

    Timmermans, Stefan

    2015-02-01

    Clinical exome sequencing is a genetic technology making the transition from a laboratory research tool to a routine clinical technique used to diagnose patients. Standards help make this transition by offering authoritative shortcuts for time-intensive tasks, but each shortcut means that something is lost during abstraction. In clinical exome sequencing, reliance on standards may obscure the match between a patient's phenotype and genotype. Based on three years of observations, I show how a clinical exome sequencing team decides when to trust standards and when to develop workarounds. I argue that the match between phenotype and genotype is circumscribed by the team's reliance on specific standards and that trusting in standards means trusting in experts' appropriate use of standards, generating a workflow of reflexive standardization.

  12. Current status on performance of CT colonography and clinical indications

    Energy Technology Data Exchange (ETDEWEB)

    Laghi, Andrea, E-mail: andrea.laghi@uniroma1.it [Department of Radiological Sciences, Oncology and Pathology Sapienza – Università di Roma, Polo Pontino, I.C.O.T. Hospital, Via Franco Faggiana 43, 04100 Latina (Italy); Rengo, Marco [Department of Radiological Sciences, Oncology and Pathology Sapienza – Università di Roma, Polo Pontino, I.C.O.T. Hospital, Via Franco Faggiana 43, 04100 Latina (Italy); Graser, Anno [InstitutfürKlinische Radiologie, Klinikumder Ludwig-Maximilians-Universität München, Campus Großhadern, Marchioninistr. 15, 81377 München (Germany); Iafrate, Franco [Department of Radiological Sciences, Oncology and Pathology Sapienza – Università di Roma, Policlinico Umberto I, Viale Regina Elena 324, 00161 Rome (Italy)

    2013-08-15

    CT colonography (CTC) is a robust and reliable imaging test of the colon. Accuracy for the detection of colorectal cancer (CRC) is as high as conventional colonoscopy (CC). Identification of polyp is size dependent, with large lesions (≥10 mm) accurately detected and small lesions (6–9 mm) identified with moderate to good sensitivity. Recent studies show good sensitivity for the identification of nonpolypoid (flat) lesions as well. Current CTC indications include the evaluation of patients who had undergone a previous incomplete CC or those who are unfit for CC (elderly and frail individuals, patients with underlying severe clinical conditions, or with contraindication to sedation). CTC can also be efficiently used in the assessment of diverticular disease (excluding patients with acute diverticulitis, where the exam should be postponed), before laparoscopic surgery for CRC (to have an accurate localization of the lesion), in the evaluation of colonic involvement in the case of deep pelvic endometriosis (replacing barium enema). CTC is also a safe procedure in patients with colostomy. For CRC screening, CTC should be considered an opportunistic screening test (not available for population, or mass screening) to be offered to asymptomatic average-risk individuals, of both genders, starting at age 50. The use in individuals with positive family history should be discussed with the patient first. Absolute contraindication is to propose CTC for surveillance of genetic syndromes and chronic inflammatory bowel diseases (in particular, ulcerative colitis). The use of CTC in the follow-up after surgery for CRC is achieving interesting evidences despite the fact that literature data are still relatively weak in terms of numerosity of the studied populations. In patients who underwent previous polypectomy CTC cannot be recommended as first test because debate is still open. It is desirable that in the future CTC would be the first-line and only diagnostic test for

  13. [Construction and thinking of data element standard directory of traditional Chinese medicine clinical pharmacy information].

    Science.gov (United States)

    Wang, Xiao-Xia; Jin, Zhong-Zheng; Guo, Gui-Ming; Zhai, Hua-Qiang; Jin, Shi-Yuan

    2014-05-01

    The aim of this study was to develop the data element standard directory of traditional Chinese medicine (TCM) clinical pharmacy information, to provide application standards and models of TCM clinical pharmacy for the electronic medical record (EMR). The developed line of work is as follows: initially establish research through four forms: literature analysis, questionnaires, discussion groups, expert advice. The research range from the Chinese herbal medicine research, herbal origin, harvesting, processing, identification of traits, physical and chemical identification, modern research, character, taste, Indications, clinical application, processing, dispensing medicine, Chinese medicine specifications, usage, dosage, caution, efficacy indications to small packaging applications, drug research, management and other related issues, including traditional Chinese medicine theory, application and hospital management information; according to the general and part 16 content of the national "Health Information Data Element Standards", and the basic method of extracting data element to study and develop the data element of TCM clinical pharmacy information from the defining content. Correspondingly propose the ideas and methods of construction of the "Data Element Standard Directory of TCM Clinical Pharmacy Information", sort out medicine clinical information data element standard catalog, divided into basic categories, clinical application class, management class three parts, and set norms and standards of identifying data elements, definitions, allowable value of traditional Chinese medicine clinical information, and discuss the sources and standards of information collection, leaving the interface, standardized and scientific terminology, docking with the existing standards, maintenance and management program and oter issues.

  14. Randomised clinical trial of early specialist palliative care plus standard care versus standard care alone in patients with advanced cancer

    DEFF Research Database (Denmark)

    Groenvold, Mogens; Petersen, Morten Aagaard; Damkier, Anette

    2017-01-01

    BACKGROUND: Beneficial effects of early palliative care have been found in advanced cancer, but the evidence is not unequivocal. AIM: To investigate the effect of early specialist palliative care among advanced cancer patients identified in oncology departments. SETTING/PARTICIPANTS: The Danish...... Palliative Care Trial (DanPaCT) (ClinicalTrials.gov NCT01348048) is a multicentre randomised clinical trial comparing early referral to a specialist palliative care team plus standard care versus standard care alone. The planned sample size was 300. At five oncology departments, consecutive patients...

  15. Genetic Testing as a New Standard for Clinical Diagnosis of Color Vision Deficiencies

    Science.gov (United States)

    Davidoff, Candice; Neitz, Maureen; Neitz, Jay

    2016-01-01

    Purpose The genetics underlying inherited color vision deficiencies is well understood: causative mutations change the copy number or sequence of the long (L), middle (M), or short (S) wavelength sensitive cone opsin genes. This study evaluated the potential of opsin gene analyses for use in clinical diagnosis of color vision defects. Methods We tested 1872 human subjects using direct sequencing of opsin genes and a novel genetic assay that characterizes single nucleotide polymorphisms (SNPs) using the MassArray system. Of the subjects, 1074 also were given standard psychophysical color vision tests for a direct comparison with current clinical methods. Results Protan and deutan deficiencies were classified correctly in all subjects identified by MassArray as having red–green defects. Estimates of defect severity based on SNPs that control photopigment spectral tuning correlated with estimates derived from Nagel anomaloscopy. Conclusions The MassArray assay provides genetic information that can be useful in the diagnosis of inherited color vision deficiency including presence versus absence, type, and severity, and it provides information to patients about the underlying pathobiology of their disease. Translational Relevance The MassArray assay provides a method that directly analyzes the molecular substrates of color vision that could be used in combination with, or as an alternative to current clinical diagnosis of color defects. PMID:27622081

  16. The Cardiology Audit and Registration Data Standards (CARDS), European data standards for clinical cardiology practice

    NARCIS (Netherlands)

    M.R. Flynn (Rachel); C. Barrett (Conor); F.G. Cosio (Francisco); A.K. Gitt (Anselm); L.C. Wallentin (Lars); P. Kearney (Peter); M. Lonergan (Moira); E. Shelley (Emer); M.L. Simoons (Maarten)

    2005-01-01

    textabstractAIMS: Systematic registration of data from clinical practice is important for clinical care, local, national and international registries, and audit. Data to be collected for these different purposes should be harmonized. Therefore, during Ireland's Presidency of the European Union (EU)

  17. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice.

    Science.gov (United States)

    Reddel, Helen K; Taylor, D Robin; Bateman, Eric D; Boulet, Louis-Philippe; Boushey, Homer A; Busse, William W; Casale, Thomas B; Chanez, Pascal; Enright, Paul L; Gibson, Peter G; de Jongste, Johan C; Kerstjens, Huib A M; Lazarus, Stephen C; Levy, Mark L; O'Byrne, Paul M; Partridge, Martyn R; Pavord, Ian D; Sears, Malcolm R; Sterk, Peter J; Stoloff, Stuart W; Sullivan, Sean D; Szefler, Stanley J; Thomas, Mike D; Wenzel, Sally E

    2009-07-01

    The assessment of asthma control is pivotal to the evaluation of treatment response in individuals and in clinical trials. Previously, asthma control, severity, and exacerbations were defined and assessed in many different ways. The Task Force was established to provide recommendations about standardization of outcomes relating to asthma control, severity, and exacerbations in clinical trials and clinical practice, for adults and children aged 6 years or older. A narrative literature review was conducted to evaluate the measurement properties and strengths/weaknesses of outcome measures relevant to asthma control and exacerbations. The review focused on diary variables, physiologic measurements, composite scores, biomarkers, quality of life questionnaires, and indirect measures. The Task Force developed new definitions for asthma control, severity, and exacerbations, based on current treatment principles and clinical and research relevance. In view of current knowledge about the multiple domains of asthma and asthma control, no single outcome measure can adequately assess asthma control. Its assessment in clinical trials and in clinical practice should include components relevant to both of the goals of asthma treatment, namely achievement of best possible clinical control and reduction of future risk of adverse outcomes. Recommendations are provided for the assessment of asthma control in clinical trials and clinical practice, both at baseline and in the assessment of treatment response. The Task Force recommendations provide a basis for a multicomponent assessment of asthma by clinicians, researchers, and other relevant groups in the design, conduct, and evaluation of clinical trials, and in clinical practice.

  18. Guidelines International Network: toward international standards for clinical practice guidelines.

    NARCIS (Netherlands)

    Qaseem, A.; Forland, F.; Macbeth, F.; Ollenschlager, G.; Phillips, S.; Wees, P.J. van der

    2012-01-01

    Guideline development processes vary substantially, and many guidelines do not meet basic quality criteria. Standards for guideline development can help organizations ensure that recommendations are evidence-based and can help users identify high-quality guidelines. Such organizations as the U.S. In

  19. Current clinical approach to patients with disorders of consciousness

    Directory of Open Access Journals (Sweden)

    Robson Luis Oliveira de Amorim

    Full Text Available Summary In clinical practice, hospital admission of patients with altered level of consciousness, sleepy or in a non-responsive state is extremely common. This clinical condition requires an effective investigation and early treatment. Performing a focused and objective evaluation is critical, with quality history taking and physical examination capable to locate the lesion and define conducts. Imaging and laboratory exams have played an increasingly important role in supporting clinical research. In this review, the main types of changes in consciousness are discussed as well as the essential points that should be evaluated in the clinical management of these patients.

  20. Standard requirements for GCP-compliant data management in multinational clinical trials

    DEFF Research Database (Denmark)

    Ohmann, Christian; Kuchinke, Wolfgang; Canham, Steve

    2011-01-01

    ). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed...... a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials....

  1. Current Practices and Opportunities in a Resident Clinic Regarding the Care of Older Adults with Multimorbidity.

    Science.gov (United States)

    Schoenborn, Nancy L; Boyd, Cynthia M; McNabney, Matthew; Ray, Anushree; Cayea, Danelle

    2015-08-01

    Multimorbidity (≥2 chronic conditions) affects more than half of all older adults. The American Geriatrics Society developed and published guiding principles for the care of older adults with multimorbidity in 2012. Improved clinician training in caring for older adults with multimorbidity is needed, but it is not clear what opportunities arise within clinical encounters to apply the guiding principles or how clinicians at all stages of training currently practice in this area. This project aimed to characterize current practice and opportunities for improvement in an internal medicine residency clinic regarding the care of older adults with multimorbidity. Qualitative content analysis of audio-recorded clinic visits. Thirty clinic visits between 21 internal medicine residents and 30 of their primary care patients aged 65 and older with two or more chronic conditions were audio-recorded. Patients' mean age was 73.6, and they had on average 3.7 chronic conditions and took 12.6 medications. Transcripts of the audio-recorded visit discussions were analyzed using standard techniques of qualitative content analysis to describe the content and frequency of discussions in the clinic visits related to the five guiding principles: patient preferences, interpreting the evidence, prognosis, clinical feasibility, and optimizing therapies. All visits except one included discussions that were thematically related to at least one guiding principle, suggesting regular opportunities to apply the guiding principles in primary care encounters with internal medicine residents. Discussions related to some guiding principles occurred much more frequently than others. Patients presented a number of opportunities to incorporate the guiding principles that the residents missed, suggesting target areas for future educational interventions. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  2. Ion transport and loss in the earth's quiet ring current. I - Data and standard model

    Science.gov (United States)

    Sheldon, R. B.; Hamilton, D. C.

    1993-01-01

    A study of the transport and loss of ions in the earth's quiet time ring current, in which the standard radial diffusion model developed for the high-energy radiation belt particles is compared with the measurements of the lower-energy ring current ions, is presented. The data set provides ionic composition information in an energy range that includes the bulk of the ring current energy density, 1-300 keV/e. Protons are found to dominate the quiet time energy density at all altitudes, peaking near L of about 4 at 60 keV/cu cm, with much smaller contributions from O(+) (1-10 percent), He(+) (1-5 percent), and He(2+) (less than 1 percent). A minimization procedure is used to fit the amplitudes of the standard electric radial diffusion coefficient, yielding 5.8 x 10 exp -11 R(E-squared)/s. Fluctuation ionospheric electric fields are suggested as the source of the additional diffusion detected.

  3. Ion transport and loss in the earth's quiet ring current. I - Data and standard model

    Science.gov (United States)

    Sheldon, R. B.; Hamilton, D. C.

    1993-01-01

    A study of the transport and loss of ions in the earth's quiet time ring current, in which the standard radial diffusion model developed for the high-energy radiation belt particles is compared with the measurements of the lower-energy ring current ions, is presented. The data set provides ionic composition information in an energy range that includes the bulk of the ring current energy density, 1-300 keV/e. Protons are found to dominate the quiet time energy density at all altitudes, peaking near L of about 4 at 60 keV/cu cm, with much smaller contributions from O(+) (1-10 percent), He(+) (1-5 percent), and He(2+) (less than 1 percent). A minimization procedure is used to fit the amplitudes of the standard electric radial diffusion coefficient, yielding 5.8 x 10 exp -11 R(E-squared)/s. Fluctuation ionospheric electric fields are suggested as the source of the additional diffusion detected.

  4. Extracting clinical information to support medical decision based on standards.

    Science.gov (United States)

    Gomoi, Valentin; Vida, Mihaela; Stoicu-Tivadar, Lăcrămioara; Stoicu-Tivadar, Vasile

    2011-01-01

    The paper presents a method connecting medical databases to a medical decision system, and describes a service created to extract the necessary information that is transferred based on standards. The medical decision can be improved based on many inputs from different medical locations. The developed solution is described for a concrete case concerning the management for chronic pelvic pain, based on the information retrieved from diverse healthcare databases.

  5. Including Alternative Resources in State Renewable Portfolio Standards: Current Design and Implementation Experience

    Energy Technology Data Exchange (ETDEWEB)

    Heeter, J.; Bird, L.

    2012-11-01

    Currently, 29 states, the District of Columbia, and Puerto Rico have instituted a renewable portfolio standard (RPS). An RPS sets a minimum threshold for how much renewable energy must be generated in a given year. Each state policy is unique, varying in percentage targets, timetables, and eligible resources. This paper examines state experience with implementing renewable portfolio standards that include energy efficiency, thermal resources, and non-renewable energy and explores compliance experience, costs, and how states evaluate, measure, and verify energy efficiency and convert thermal energy. It aims to gain insights from the experience of states for possible federal clean energy policy as well as to share experience and lessons for state RPS implementation.

  6. "Heidelberg standard examination" and "Heidelberg standard procedures" - Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education.

    Science.gov (United States)

    Nikendei, C; Ganschow, P; Groener, J B; Huwendiek, S; Köchel, A; Köhl-Hackert, N; Pjontek, R; Rodrian, J; Scheibe, F; Stadler, A-K; Steiner, T; Stiepak, J; Tabatabai, J; Utz, A; Kadmon, M

    2016-01-01

    The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects "Heidelberg standard examination" and "Heidelberg standard procedures", which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

  7. Current status of the Standard Model CKM fit and constraints on $\\Delta F=2$ New Physics

    CERN Document Server

    Charles, J; Descotes-Genon, S; Lacker, H; Menzel, A; Monteil, S; Niess, V; Ocariz, J; Orloff, J; Perez, A; Qian, W; Tisserand, V; Trabelsi, K; Urquijo, P; Silva, L Vale

    2015-01-01

    This letter summarises the status of the global fit of the CKM parameters within the Standard Model performed by the CKMfitter group. Special attention is paid to the inputs for the CKM angles $\\alpha$ and $\\gamma$ and the status of $B_s\\to\\mu\\mu$ and $B_d\\to \\mu\\mu$ decays. We illustrate the current situation for other unitarity triangles. We also discuss the constraints on generic $\\Delta F=2$ New Physics. All results have been obtained with the CKMfitter analysis package, featuring the frequentist statistical approach and using Rfit to handle theoretical uncertainties.

  8. Automated standardized pupillometry with optical method for purposes of clinical practice and research.

    Science.gov (United States)

    Fotiou, F; Fountoulakis, K N; Goulas, A; Alexopoulos, L; Palikaras, A

    2000-09-01

    The aim of the current study was the introduction and standardization of two experimental conditions for dynamic pupillometry. Pupillometry is a method that can provide valuable data concerning the functioning of the autonomous nervous system. The system for recording the pupil reaction was developed in the Laboratory of Clinical Neurophysiology of the 1st Department of Neurology of Aristotle University of Thessaloniki, in co-operation with the Laboratory of Fluid Mechanics of the Aristotle University of Thessaloniki. This system is fully automated. It includes an infra-red video camera, which has the capacity to record in complete darkness, and an SLE (clinical photic stimulator) lamp. A software application automatically performed all the procedures. During the first experiment, one flash was administered. During the second experiment, a series of 25 flashes (1 Hz frequency) was administered. Fifty physically and mentally healthy subjects aged 23-48 years took part in the study. Means, standard deviations and ranges for all variables characterizing normal subjects during both experimental conditions are reported. Test/re-test results and comparisons of the two eyes are also reported. The combined use of these two experimental conditions in dynamic pupillometry may be a very useful tool in medical research. There are already reports on the usefulness of pupillometry in the research of various diseases, including depression and Alzheimer's disease. It is expected that it will also be a valuable research tool in the study of diabetes, alcoholism, myasthenia gravis, cancer, multiple sclerosis, etc.

  9. Monolithic integration of GMR sensors for standard CMOS-IC current sensing

    Science.gov (United States)

    De Marcellis, A.; Reig, C.; Cubells-Beltrán, M.-D.; Madrenas, J.; Santos, J. D.; Cardoso, S.; Freitas, P. P.

    2017-09-01

    In this work we report on the development of Giant Magnetoresistive (GMR) sensors for off-line current measurements in standard integrated circuits. An ASIC has been specifically designed and fabricated in the well-known AMS-0.35 μm CMOS technology, including the electronic circuitry for sensor interfacing. It implements an oscillating circuit performing a voltage-to-frequency conversion. Subsequently, a fully CMOS-compatible low temperature post-process has been applied for depositing the GMR sensing devices in a full-bridge configuration onto the buried current straps. Sensitivity and resolution of these sensors have been investigated achieving experimental results that show a detection sensitivity of about 100 Hz/mA, with a resolution of about 5 μA.

  10. The role of the standard EEG in clinical psychiatry.

    LENUS (Irish Health Repository)

    O'Sullivan, S S

    2012-02-03

    BACKGROUND: The EEG is a commonly requested test on patients attending psychiatric services, predominantly to investigate for a possible organic brain syndrome causing behavioural changes. AIMS: To assess referrals for EEG from psychiatric services in comparison with those from other sources. We determine which clinical factors were associated with an abnormal EEG in patients referred from psychiatric sources. METHODS: A retrospective review of EEG requests in a 1-year period was performed. Analysis of referral reasons for psychiatric patients was undertaken, and outcome of patients referred from psychiatric services post-EEG was reviewed. RESULTS: One thousand four hundred and seventy EEGs were reviewed, of which 91 (6.2%) were referred from psychiatry. Neurology service referrals had detection rates of abnormal EEGs of 27%, with psychiatric referrals having the lowest abnormality detection rate of 17.6% (p < 0.1). In psychiatric-referred patients the only significant predictors found of an abnormal EEG were a known history of epilepsy (p < 0.001), being on clozapine (p < 0.05), and a possible convulsive seizure (RR = 6.51). Follow-up data of 53 patients did not reveal a significant clinical impact of EEG results on patient management. CONCLUSIONS: Many patients are referred for EEG from psychiatric sources despite a relatively low index of suspicion of an organic brain disorders, based on reasons for referral documented, with an unsurprising low clinical yield.

  11. Currently Clinical Views on Genetics of Wilson′s Disease

    OpenAIRE

    Chen Chen; Bo Shen; Jia-Jia Xiao; Rong Wu; Sarah Jane Duff Canning; Xiao-Ping Wang

    2015-01-01

    Objective: The objective of this study was to review the research on clinical genetics of Wilson′s disease (WD). Data Sources: We searched documents from PubMed and Wanfang databases both in English and Chinese up to 2014 using the keywords WD in combination with genetic, ATP7B gene, gene mutation, genotype, phenotype. Study Selection: Publications about the ATP7B gene and protein function associated with clinical features were selected. Results: Wilson′s disease, also named hepat...

  12. Impacts of China's Current Appliance Standards and LabelingProgram to 2020

    Energy Technology Data Exchange (ETDEWEB)

    Fridley, David; Aden, Nathaniel; Zhou, Nan; Lin, Jiang

    2007-03-03

    The report summarizes the history and nature of China sstandardsand labeling program in the Introduction in Section 1. Trends indomestic production, exports, penetration rates, unit energy consumptionand the history of S&L technical levels by product are discussed ingreat detail in Section 2. The national energy impactsanalysis found inSection 3 concludes that overall China s standards and labeling programsreduce total electricity consumption in 2020 by an annual 106 TWh, or 16percent of what would otherwise been expected in that year in the absenceof standards and labeling programs.In total, the report concludes thatthe S&L programs currently in place in China are expected to save acumulative 1143 TWh by 2020, or 9 percent of the cumulative consumptionof residential electricity to that year. In 2020 alone, annual savingsare expected to be equivalent to 11 percent of residential electricityuse. In average generation terms, this is equivalent to 27 1-GW coalfired plants that would have required around 75 million tonnes of coal tooperate.In comparison, savings from the US appliance standards programalone is expected to save 10 percent of residential electricityconsumption in 2020.

  13. Flavour changing neutral currents in the standard model and its extensions with singlet quarks

    CERN Document Server

    Bejlin, V A; Kuksa, V I

    2001-01-01

    The review is devoted to the phenomenology of singlet quarks, which are singlets with respect to the SU(2), have hypercharges Y = -1/3 masses m > m sub t. It is shown, that experimental data on rare processes and the corresponding theoretical predictions of the Standard Model (SM) allow to invoke the SM extensions for the analysis of the phenomena stimulated by flavor changing neutral current. The extended matrix of standard and singlet quark mixing is constructed, the restriction on mixing angles and the estimate of low bound of singlet quark mass m sub D >= 0.5 TeV are obtained. Besides the direct observation the perspectives to increase the confidence level of the singlet quark existence are discussed. The cross-sections of nondiagonal production of singlet quark in pair with standard one in e sup - e sup + -, ep- and pp-bar-collisions are analyzed and the unique signature of such events is described. The model of up-singlet quark with the hypercharge Y sub U 2/3 and its applications to the physics of t-qu...

  14. Detecting and Correcting for Rater-Induced Differences in Standardized Patient Tests of Clinical Competence.

    Science.gov (United States)

    Abrahamowicz, Michal; And Others

    1990-01-01

    In standardized patient-based tests of clinical competence, patients are used to present the clinical problem and to rate the actions taken by the student. This approach is evaluated by a microanalysis of 1 case used in a fourth year clinical examination of 98 medical students at the University of Manitoba. (MLW)

  15. Currently Clinical Views on Genetics of Wilson's Disease

    Institute of Scientific and Technical Information of China (English)

    Chen Chen; Bo Shen; Jia-Jia Xiao; Rong Wu; Sarah Jane Duff Canning; Xiao-Ping Wang

    2015-01-01

    Objective:The objective of this study was to review the research on clinical genetics of Wilson's disease (WD).Data Sources:We searched documents from PubMed and Wanfang databases both in English and Chinese up to 2014 using the keywords WD in combination with genetic,ATP7B gene,gene mutation,genotype,phenotype.Study Selection:Publications about the ATP7B gene and protein function associated with clinical features were selected.Results:Wilson's disease,also named hepatolenticular degeneration,is an autosomal recessive genetic disorder characterized by abnormal copper metabolism caused by mutations to the copper-transporting gene A TP7B.Decreased biliary copper excretion and reduced incorporation of copper into apoceruloplasmin caused by defunctionalization of ATP7B protein lead to accumulation of copper in many tissues and organs,including liver,brain,and cornea,finally resulting in liver disease and extrapyramidal symptoms.It is the most common genetic neurological disorder in the onset of adolescents,second to muscular dystrophy in China.Early diagnosis and medical therapy are of great significance for improving the prognosis of WD patients.However,diagnosis of this disease is usually difficult because of its complicated phenotypes.In the last 10 years,an increasing number of clinical studies have used molecular genetics techniques.Improved diagnosis and prediction of the progression of this disease at the molecular level will aid in the development of more individualized and effective interventions,which is a key to transition from molecular genetic research to the clinical study.Conclusions:Clinical genetics studies are necessary to understand the mechanism underlying WD at the molecular level from the genotype to the phenotype.Clinical genetics research benefits newly emerging medical treatments including stem cell transplantation and gene therapy for WD patients.

  16. Primary hyperparathyroidism: epidemiology, clinical features, diagnostic tools and current management

    Directory of Open Access Journals (Sweden)

    Andrea Percivale

    2015-12-01

    Full Text Available Primary hyperparathyroidism (PHPT is a clinical condition characterized by overactive parathyroid gland secretion of parathyroid hormone with concurrent alteration of the phosphocalcemic metabolism. We present a literature review on primary hyperparathyroidism addressing key on clinical presentation, causes, medical and surgical treatment at the best of our knowledge. Based on this review we confirm the role of serum calcium and serum level examination, as well as we define the definitive treatment for PHPT being parathyroidectomy. In case of contraindication for surgery, medical treatment can play a relevant role.

  17. Review of current and evolving clinical indications forendoscopic ultrasound

    Institute of Scientific and Technical Information of China (English)

    2016-01-01

    For the first several years after its development,endoscopic ultrasound (EUS) was primarily limited toidentification of pancreatic malignancies. Since thistime, the field of EUS has advanced at a tremendousspeed in terms of additional clinical diagnostic andtherapeutic uses. The combination of ultrasound withendoscopy provides a unique interventional modalitythat is a minimally invasive alternative to various surgicalinterventions. Given the expanding recommendedindications for EUS, this article will serve to review themost common uses with supporting evidence, while alsoexploring innovative endeavors that may soon becomecommon clinical practice.

  18. National Mesothelioma Virtual Bank: A standard based biospecimen and clinical data resource to enhance translational research

    Directory of Open Access Journals (Sweden)

    Valdivieso Federico A

    2008-08-01

    Full Text Available Abstract Background Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. Methods The National Mesothelioma Virtual Bank architecture is based on three major components: (a common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards, (b clinical and epidemiologic data annotation, and (c data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid™ (caBIG™, see http://cabig.nci.nih.gov. This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. Result The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. Conclusion The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational

  19. National Mesothelioma Virtual Bank: a standard based biospecimen and clinical data resource to enhance translational research.

    Science.gov (United States)

    Amin, Waqas; Parwani, Anil V; Schmandt, Linda; Mohanty, Sambit K; Farhat, Ghada; Pople, Andrew K; Winters, Sharon B; Whelan, Nancy B; Schneider, Althea M; Milnes, John T; Valdivieso, Federico A; Feldman, Michael; Pass, Harvey I; Dhir, Rajiv; Melamed, Jonathan; Becich, Michael J

    2008-08-13

    Advances in translational research have led to the need for well characterized biospecimens for research. The National Mesothelioma Virtual Bank is an initiative which collects annotated datasets relevant to human mesothelioma to develop an enterprising biospecimen resource to fulfill researchers' need. The National Mesothelioma Virtual Bank architecture is based on three major components: (a) common data elements (based on College of American Pathologists protocol and National North American Association of Central Cancer Registries standards), (b) clinical and epidemiologic data annotation, and (c) data query tools. These tools work interoperably to standardize the entire process of annotation. The National Mesothelioma Virtual Bank tool is based upon the caTISSUE Clinical Annotation Engine, developed by the University of Pittsburgh in cooperation with the Cancer Biomedical Informatics Grid (caBIG, see http://cabig.nci.nih.gov). This application provides a web-based system for annotating, importing and searching mesothelioma cases. The underlying information model is constructed utilizing Unified Modeling Language class diagrams, hierarchical relationships and Enterprise Architect software. The database provides researchers real-time access to richly annotated specimens and integral information related to mesothelioma. The data disclosed is tightly regulated depending upon users' authorization and depending on the participating institute that is amenable to the local Institutional Review Board and regulation committee reviews. The National Mesothelioma Virtual Bank currently has over 600 annotated cases available for researchers that include paraffin embedded tissues, tissue microarrays, serum and genomic DNA. The National Mesothelioma Virtual Bank is a virtual biospecimen registry with robust translational biomedical informatics support to facilitate basic science, clinical, and translational research. Furthermore, it protects patient privacy by disclosing only

  20. Potential facilitators and barriers to adopting standard treatment guidelines in clinical practice.

    Science.gov (United States)

    Sharma, Sangeeta; Pandit, Ajay; Tabassum, Fauzia

    2017-04-18

    Purpose The purpose of this paper is to assess medicines information sources accessed by clinicians, if sources differed in theory and practice and to find out the barriers and facilitators to effective guideline adoption. Design/methodology/approach In all, 183 doctors were surveyed. Barriers and facilitators were classified as: communication; potential adopters; innovation; organization characteristics and environmental/social/economic context. Findings Most of the clinicians accessed multiple information sources including standard treatment guidelines, but also consulted seniors/colleagues in practice. The top three factors influencing clinical practice guideline adoption were innovation characteristics, environmental context and individual characteristics. The respondents differed in the following areas: concerns about flexibility offered by the guideline; denying patients' individuality; professional autonomy; insights into gaps in current practice and evidence-based practice; changing practices with little or no benefit. Barriers included negative staff attitudes/beliefs, guideline integration into organizational structures/processes, time/resource constraints. Fearing third parties (government and insurance companies) restricting medicines reimbursement and poor liability protection offered by the guidelines emerged as the barriers. Facilitators include aligning organizational structures/processes with the innovation; providing leadership support to guide diffusion; increasing awareness and enabling early innovation during pre/in-service training, with regular feedback on outcomes and use. Practical implications Guideline adoption in clinical practice is partly within doctors' control. There are other key prevailing factors in the local context such as environmental, social context, professional and organizational culture affecting its adoption. Organizational policy and accreditation standards necessitating adherence can serve as a driver. Originality

  1. Ligand-targeted particulate nanomedicines undergoing clinical evaluations: current status

    NARCIS (Netherlands)

    Meel, van der Roy; Vehmeijer, Laurens J.C.; Kok, Robbert J.; Storm, Gert; Gaal, van Ethlinn V.B.

    2013-01-01

    Since the introduction of Doxil® on the market nearly 20 years ago, a number of nanomedicines have become part of treatment regimens in the clinic. With the exception of antibody–drug conjugates, these nanomedicines are all devoid of targeting ligands and rely solely on their physicochemical propert

  2. Current clinical trials testing combinations of immunotherapy and radiation.

    Science.gov (United States)

    Crittenden, Marka; Kohrt, Holbrook; Levy, Ronald; Jones, Jennifer; Camphausen, Kevin; Dicker, Adam; Demaria, Sandra; Formenti, Silvia

    2015-01-01

    Preclinical evidence of successful combinations of ionizing radiation with immunotherapy has inspired testing the translation of these results to the clinic. Interestingly, the preclinical work has consistently predicted the responses encountered in clinical trials. The first example came from a proof-of-principle trial started in 2001 that tested the concept that growth factors acting on antigen-presenting cells improve presentation of tumor antigens released by radiation and induce an abscopal effect. Granulocyte-macrophage colony-stimulating factor was administered during radiotherapy to a metastatic site in patients with metastatic solid tumors to translate evidence obtained in a murine model of syngeneic mammary carcinoma treated with cytokine FLT-3L and radiation. Subsequent clinical availability of vaccines and immune checkpoint inhibitors has triggered a wave of enthusiasm for testing them in combination with radiotherapy. Examples of ongoing clinical trials are described in this report. Importantly, most of these trials include careful immune monitoring of the patients enrolled and will generate important data about the proimmunogenic effects of radiation in combination with a variety of immune modulators, in different disease settings. Results of these studies are building a platform of evidence for radiotherapy as an adjuvant to immunotherapy and encourage the growth of this novel field of radiation oncology.

  3. Establishment of the European College of Veterinary Clinical Pathology (ECVCP) and the current status of veterinary clinical pathology in Europe.

    Science.gov (United States)

    O'Brien, P J; Fournel-Fleury, C; Bolliger, A P; Freeman, K P; Braun, J-P; Archer, J; Paltrinieri, S; Tvedten, H; Polizopoulou, Z S; Jensen, A L; Pastor, J; Lanevschi-Pietersma, A; Thoren-Tolling, K; Schwendenwien, I; Thoresen, S I; Bauer, N B; Ledieu, D; Cerón, J J; Palm, M; Papasouliotis, K; Gaál, T; Vajdovich, P

    2007-12-01

    After 5 years of development, the European College of Veterinary Clinical Pathology (ECVCP) was formally recognized and approved on July 4, 2007 by the European Board of Veterinary Specialisation (EBVS), the European regulatory body that oversees specialization in veterinary medicine and which has approved 23 colleges. The objectives, committees, basis for membership, constitution, bylaws, information brochure and certifying examination of the ECVCP have remained unchanged during this time except as directed by EBVS. The ECVCP declared full functionality based on the following criteria: 1) a critical mass of 65 members: 15 original diplomates approved by the EBVS to establish the ECVCP, 37 de facto diplomates, 7 diplomates certified by examination, and 5 elected honorary members; 2) the development and certification of training programs, laboratories, and qualified supervisors for residents; currently there are 18 resident training programs in Europe; 3) administration of 3 annual board-certifying examinations thus far, with an overall pass rate of 70%; 4) European consensus criteria for assessing the continuing education of specialists every 5 years; 5) organization of 8 annual scientific congresses and a joint journal (with the American Society for Veterinary Clinical Pathology) for communication of scientific research and information; the College also maintains a website, a joint listserv, and a newsletter; 6) collaboration in training and continuing education with relevant colleges in medicine and pathology; 7) development and strict adherence to a constitution and bylaws compliant with the EBVS; and 8) demonstration of compelling rationale, supporting data, and the support of members and other colleges for independence as a specialty college. Formal EBVS recognition of ECVCP as the regulatory body for the science and practice of veterinary clinical pathology in Europe will facilitate growth and development of the discipline and compliance of academic

  4. Current approach to masked hypertension: From diagnosis to clinical management.

    LENUS (Irish Health Repository)

    Dolan, Eamon

    2013-11-28

    The term masked hypertension phenomenon was first described by the late Professor Thomas Pickering and is commonly defined as having a normal clinic blood pressure (BP) but an elevated "out of office" reading. In the main these elevated readings have been provided through ambulatory blood pressure monitoring (ABPM) but sometimes home BP monitoring is used. It is now largely accepted that ABPM gives a better classification of risk than clinic BP. Thus the elevated ABPM levels should relate to higher cardiovascular risk and it follows that these people might be regarded as being genuinely hypertensive and at higher cardiovascular risk. The problem for clinical practice is how to identify and manage these subjects. The phenomenon should be suspected in subjects who have had an elevated clinic BP at some time, in young subjects with normal or normal-high clinic BP who have early left ventricular hypertrophy, in subjects with a family history of hypertension in both parents, patients with multiple risks for cardiovascular disease and perhaps diabetic patients. It appears to be more prevalent in subjects of male gender, with younger age, higher heart rate, obesity or high cholesterol levels and in smokers. Those with masked hypertension are at higher risk of events such as stroke and have a higher prevalence of target organ damage, for example, nephropathy. In conclusion most of the debate around this topic relates to its reliable identification. Given the higher ambulatory readings there is an increases cardiovascular risk making this diagnosis important. This article is protected by copyright. All rights reserved.

  5. Minimum reporting standards for clinical research on groin pain in athletes

    DEFF Research Database (Denmark)

    Delahunt, Eamonn; Thorborg, Kristian; Khan, Karim M

    2015-01-01

    are provided in relation to: (1) study methodology, (2) study participants and injury history, (3) clinical examination, (4) clinical assessment and (5) radiology. Adherence to these minimum reporting standards will strengthen the quality and transparency of research conducted on groin pain in athletes...... to generalise findings to the target patient population. Minimum reporting standards for research on groin pain in athletes are overdue. We propose a set of minimum reporting standards based on best available evidence to be utilised in future research on groin pain in athletes. Minimum reporting standards...

  6. Current status and perspectives of interventional clinical trials for glioblastoma - analysis of ClinicalTrials.gov.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Minniti, Giuseppe; Lagerwaard, Frank J; Herrlinger, Ulrich; Mathier, Etienne; Soldatovic, Ivan; Jeremic, Branislav; Ghadjar, Pirus; Elicin, Olgun; Lössl, Kristina; Aebersold, Daniel M; Belka, Claus; Herrmann, Evelyn; Niyazi, Maximilian

    2017-01-03

    The records of 208.777 (100%) clinical trials registered at ClinicalTrials.gov were downloaded on the 19th of February 2016. Phase II and III trials including patients with glioblastoma were selected for further classification and analysis. Based on the disease settings, trials were classified into three groups: newly diagnosed glioblastoma, recurrent disease and trials with no differentiation according to disease setting. Furthermore, we categorized trials according to the experimental interventions, the primary sponsor, the source of financial support and trial design elements. Trends were evaluated using the autoregressive integrated moving average model. Two hundred sixteen (0.1%) trials were selected for further analysis. Academic centers (investigator initiated trials) were recorded as primary sponsors in 56.9% of trials, followed by industry 25.9%. Industry was the leading source of monetary support for the selected trials in 44.4%, followed by 25% of trials with primarily academic financial support. The number of newly initiated trials between 2005 and 2015 shows a positive trend, mainly through an increase in phase II trials, whereas phase III trials show a negative trend. The vast majority of trials evaluate forms of different systemic treatments (91.2%). In total, one hundred different molecular entities or biologicals were identified. Of those, 60% were involving drugs specifically designed for central nervous system malignancies. Trials that specifically address radiotherapy, surgery, imaging and other therapeutic or diagnostic methods appear to be rare. Current research in glioblastoma is mainly driven or sponsored by industry, academic medical oncologists and neuro-oncologists, with the majority of trials evaluating forms of systemic therapies. Few trials reach phase III. Imaging, radiation therapy and surgical procedures are underrepresented in current trials portfolios. Optimization in research portfolio for glioblastoma is needed.

  7. The polymerase chain reaction: current and future clinical applications.

    OpenAIRE

    Lynch, J R; Brown, J. M.

    1990-01-01

    The polymerase chain reaction has undergone rapid improvement since its initial development, such that the technique currently permits rapid, accurate, predictive tests to be made in the field of prenatal diagnosis and has greatly aided forensic medicine. It is anticipated that the polymerase chain reaction will also facilitate advances in other fields, in particular preimplantation diagnosis, virology, bacteriology, and cancer therapy.

  8. Current issues with standards in the measurement and documentation of human skeletal anatomy.

    Science.gov (United States)

    Magee, Justin; McClelland, Brian; Winder, John

    2012-09-01

    Digital modeling of human anatomy has become increasingly important and relies on well-documented quantitative anatomy literature. This type of documentation is common for the spine and pelvis; however, significant issues exist due to the lack of standardization in measurement and technique. Existing literature on quantitative anatomy for the spine and pelvis of white adults (aged 18-65 years, separated into decadal categories) was reviewed from the disciplines of anatomy, manipulative therapy, anthropometrics, occupational ergonomics, biomechanics and forensic science. The data were unified into a single normative model of the sub-axial spine. Two-dimensional orthographic drawings were produced from the 590 individual measurements identified, which informed the development of a 3D digital model. A similar review of full range of motion data was conducted as a meta-analysis and the results were applied to the existing model, providing an inter-connected, articulated digital spine. During these data analysis processes several inconsistencies were observed accompanied by an evidential lack of standardization with measurement and recording of data. These have been categorized as: anatomical terminology; scaling of measurements; measurement methodology, dimension and anatomical reference positions; global coordinate systems. There is inconsistency in anatomical terminology where independent researchers use the same terms to describe different aspects of anatomy or different terms for the same anatomy. Published standards exist for measurement methods of the human body regarding spatial interaction, anthropometric databases, automotive applications, clothing industries and for computer manikins, but none exists for skeletal anatomy. Presentation of measurements often lacks formal structure in clinical publications, seldom providing geometric reference points, therefore making digital reconstruction difficult. Published quantitative data does not follow existing

  9. Current trends in the clinical development of peptide therapeutics.

    Science.gov (United States)

    Saladin, Pauline M; Zhang, Bodi D; Reichert, Janice M

    2009-12-01

    The development of peptides as drugs is attracting increasing attention from the pharmaceutical industry. This interest is at least partially a consequence of the widespread acceptance of therapeutic proteins by physicians and patients, and because of improvements to problems such as a short half-life and delivery issues. The markets for peptide-based compounds can be substantial, with six peptide drugs attaining global sales of more than US $750 million in 2008. To track trends in the clinical development and marketing approval of peptides, Tufts Center for the Study of Drug Development and Ferring Research Institute compiled publically available data for peptides that entered clinical trials sponsored by commercial firms, with a focus on peptide therapeutics, but also including peptide vaccines and diagnostics. The results provide an historical overview of the development of peptide therapeutics, and may inform strategic planning in this area.

  10. CSF-1R Inhibitor Development: Current Clinical Status.

    Science.gov (United States)

    Peyraud, Florent; Cousin, Sophie; Italiano, Antoine

    2017-09-05

    Colony-stimulating factor 1 receptor (CSF-1R) and its ligands, CSF-1 and interleukin 34 (IL-34), regulate the function and survival of tumor-associated macrophages, which are involved in tumorigenesis and in the suppression of antitumor immunity. Moreover, the CSF-1R/CSF-1 axis has been implicated in the pathogenesis of pigmented villonodular synovitis (PVNS), a benign tumor of the synovium. As advanced or metastatic malignant solid tumors and relapsed/refractory PVNS remain unresolved therapeutic problems, new approaches are needed to improve the outcome of patients with these conditions. In solid tumors, targeting CSF-1R via either small molecules or antibodies has shown interesting results in vitro but limited antitumor activity in vivo. Concerning PVNS, clinical trials assessing CSF-1R inhibitors have revealed promising initial outcomes. Blocking CSF-1/CSF-1R signaling represents a promising immunotherapy approach and several new potential combination therapies for future clinical testing.

  11. Current clinical management strategies for benign prostatic hyperplasia

    Institute of Scientific and Technical Information of China (English)

    ZHANG Xiang-hua

    2008-01-01

    @@ This article summarizes the major new findings on clinical management for benign prostatic hyperplasia (BPH) that were presented at the annual meeting of the American Urological Association (AUA) in May 2008.The management of symptomatic BPH has been changed significantly over the last decade in response to the availability of new treatment options.Prior to the 1980s,open prostatectomy was the only widely accepted intervention for BPH.Since then,the advent of new medical therapies for BPH and the introduction of a range of minimally invasive therapies have provided for men with lower urinary tract symptoms (LUTS) secondary to BPH.1 In this year's AUA meeting,several new findings were reported in the filed of BPH which involved epidemiology,clinical progression,drug therapy and new technologies in surgical therapy of BPH.

  12. Pleiotropic effects of niacin: Current possibilities for its clinical use.

    Science.gov (United States)

    Zeman, Miroslav; Vecka, Marek; Perlík, František; Staňková, Barbora; Hromádka, Robert; Tvrzická, Eva; Širc, Jakub; Hrib, Jakub; Žák, Aleš

    2016-12-01

    Niacin was the first hypolipidemic drug to significantly reduce both major cardiovascular events and mortality in patients with cardiovascular disease. Niacin favorably influences all lipoprotein classes, including lipoprotein[a],and belongs to the most potent hypolipidemic drugs for increasing HDL-C. Moreover, niacin causes favorable changes to the qualitative composition of lipoprotein HDL. In addition to its pronounced hypolipidemic action, niacin exerts many other, non-hypolipidemic effects (e.g., antioxidative, anti-inflammatory, antithrombotic), which favorably influence the development and progression of atherosclerosis. These effects are dependent on activation of the specific receptor HCA2. Recent results published by the two large clinical studies, AIM-HIGH and HPS2-THRIVE, have led to the impugnation of niacin's role in future clinical practice. However, due to several methodological flaws in the AIM-HIGH and HPS2-THRIVE studies, the pleiotropic effects of niacin now deserve thorough evaluation. This review summarizes the present and possible future use of niacin in clinical practice in light of its newly recognized pleiotropic effects.

  13. Everolimus-eluting stents: update on current clinical studies

    Directory of Open Access Journals (Sweden)

    Allocco DJ

    2011-07-01

    Full Text Available Dominic J Allocco, Anita A Joshi, Keith D DawkinsBoston Scientific Corporation, Natick, MA, USAAbstract: Everolimus-eluting stents (EES have become the most commonly implanted coronary stents worldwide. This review describes and analyzes the clinical data supporting the use of EES, focusing primarily on published, randomized, controlled trials. Everolimuseluting stents have been shown to have less restenosis, stent thrombosis, and periprocedural myocardial infarction compared with earlier generation paclitaxel-eluting stents (PES. Lower rates of adverse events for EES compared with PES were generally seen in all subgroups, with the notable exception of patients with diabetes mellitus. There have been fewer, randomized, clinical trials comparing EES with either sirolimus-eluting stents or zotarolimus-eluting stents, although very good results with EES have been observed in the trials that have been performed. Recent clinical trial data suggest that this excellent safety and efficacy profile is maintained in a next-generation EES designed to have improved mechanical properties and radiopacity.Keywords: drug-eluting stents, everolimus, Xience V, Promus, Promus ElementVideo Abstract:  http://dvpr.es/allocco  

  14. Standardizing clinical trials workflow representation in UML for international site comparison.

    Science.gov (United States)

    de Carvalho, Elias Cesar Araujo; Jayanti, Madhav Kishore; Batilana, Adelia Portero; Kozan, Andreia M O; Rodrigues, Maria J; Shah, Jatin; Loures, Marco R; Patil, Sunita; Payne, Philip; Pietrobon, Ricardo

    2010-11-09

    With the globalization of clinical trials, a growing emphasis has been placed on the standardization of the workflow in order to ensure the reproducibility and reliability of the overall trial. Despite the importance of workflow evaluation, to our knowledge no previous studies have attempted to adapt existing modeling languages to standardize the representation of clinical trials. Unified Modeling Language (UML) is a computational language that can be used to model operational workflow, and a UML profile can be developed to standardize UML models within a given domain. This paper's objective is to develop a UML profile to extend the UML Activity Diagram schema into the clinical trials domain, defining a standard representation for clinical trial workflow diagrams in UML. Two Brazilian clinical trial sites in rheumatology and oncology were examined to model their workflow and collect time-motion data. UML modeling was conducted in Eclipse, and a UML profile was developed to incorporate information used in discrete event simulation software. Ethnographic observation revealed bottlenecks in workflow: these included tasks requiring full commitment of CRCs, transferring notes from paper to computers, deviations from standard operating procedures, and conflicts between different IT systems. Time-motion analysis revealed that nurses' activities took up the most time in the workflow and contained a high frequency of shorter duration activities. Administrative assistants performed more activities near the beginning and end of the workflow. Overall, clinical trial tasks had a greater frequency than clinic routines or other general activities. This paper describes a method for modeling clinical trial workflow in UML and standardizing these workflow diagrams through a UML profile. In the increasingly global environment of clinical trials, the standardization of workflow modeling is a necessary precursor to conducting a comparative analysis of international clinical trials

  15. Clinical Challenges to Current Molecularly Targeted Therapies in Lung Cancer.

    Science.gov (United States)

    Chhabra, Gagan; Eggert, Ashley; Puri, Neelu

    Lung cancer is difficult to treat with a poor prognosis and a five year survival of 15%. Current molecularly targeted therapies are initially effective in non-small cell lung cancer (NSCLC) patients; however, they are plagued with difficulties including induced resistance and small therapeutically responsive populations. This mini review describes the mechanism of resistance to several molecularly targeted therapies which are currently being used to treat NSCLC. The major targets discussed are c-Met, EGFR, HER2, ALK, VEGFR, and BRAF. The first generation tyrosine kinase inhibitors (TKIs) resulted in resistance; however, second and third generation TKIs are being developed, which are generally more efficacious and have potential to treat NSCLC patients with resistance to first generation TKIs. Combination therapies could also be effective in preventing TKI resistance in NSCLC patients.

  16. Coenzyme Q10 therapy in current clinical practice

    Directory of Open Access Journals (Sweden)

    Abhishek Soni

    2015-04-01

    Full Text Available Coenzyme Q10 (CoQ10 is a naturally occurring, lipid soluble, essential compound and is also known as ubiquinone. CoQ10 acts as an intermediate of the electron transport chain situated in membrane of mitochondria and vital for ATP production and cellular respiration. CoQ10 also serves as an intercellular antioxidant. All the clinical use of CoQ10 are based upon these two functions. CoQ10 levels are altered in a number of oncological as well as non-oncological diseases. Furthermore, recent data indicate that CoQ10 has an impact on the expression of many genes involved in metabolism, cellular transport, transcription control, and cell signaling, making CoQ10 a potent gene regulator. CoQ10 supplementation is useful in diseases associated with CoQ10 deficiency which includes primary and secondary CoQ10 deficiencies, fibromyalgia, diabetes mellitus, mitochondrial diseases, neurodegenerative diseases, cardiovascular disease, cancer, male infertility and periodontal disease. Clinical presentations of severe CoQ10 deficiency include severe infantile multisystemic disease, encephalomyopathy, isolated myopathy cerebellar ataxia and Leigh syndrome with growth retardation. Oral CoQ10 administration can correct CoQ10 deficiency since it increases CoQ10 tissue levels. CoQ10 therapy has no serious side effects in humans and new formulations have been developed that increase CoQ10 absorption and tissue distribution. Future trends involving CoQ10 in many diseases needs more clinical trials for better understanding of CoQ10 efficacy. [Int J Res Med Sci 2015; 3(4.000: 817-825

  17. Lowering standards of clinical waste management: do the hazardous waste regulations conflict with the CDC's universal/standard precautions?

    Science.gov (United States)

    Blenkharn, J I

    2006-04-01

    Clinical waste is a costly and troublesome commodity. Comprising the detritus of medical care, the foremost hazard is the risk of infection from micro-organisms present in these wastes. Infection commonly occurs through penetrating injury, the so-called 'sharps' or 'needlestick' injury, although contamination of non-intact skin or splashes to the eye may transmit infection. Bloodborne viruses (hepatitis B, hepatitis C, human immunodeficiency virus) are the most serious threat, although respiratory, soft tissue and enteric infections are not unknown. The European Hazardous Waste Directive, that harmonizes the categorization and control of wastes, permits downregulation of clinical wastes where the risk of infection may be low. Although strengthened by the requirement for risk assessment in waste classification, UK regulatory guidance promoting classification of some clinical wastes as non-hazardous completely ignores the Centers for Disease Control and Prevention's Universal Precautions for the prevention of transmission of human immunodeficiency virus, hepatitis B virus and other bloodborne pathogens in healthcare settings, which seek to prevent bloodborne virus infection in healthcare workers and others, and the more extensive Standard Precautions that extend these principles to the prevention of healthcare-associated infections and the environmental spread of nosocomial pathogens. By creating a potent cost driver encouraging downregulation of some clinical wastes, UK legislation based on the European Hazardous Waste Directive conflicts with the CDC's Universal/Standard Precautions.

  18. [Clinical neuropsychology in perspective: future challenges based on current developments].

    Science.gov (United States)

    Verdejo-García, Antonio; Tirapu-Ustárroz, Javier

    2012-02-01

    New lines of translational, interdisciplinary research are emerging among different fields of the neurosciences, which often point at clinical neuropsychology as the hinge discipline capable of linking the basic findings with their clinical implications and thereby endow them with some meaning for phenomenological experience. To establish the great lines of progress made in the fields of neuroscience and neuropsychology in recent years, so as to be able to foresee the strategic lines and priorities of neuroscience in the near future. To achieve this aim, the first step will be to identify the changes of paradigm that have taken place in the areas of neuroscience and psychology in the last two decades. The next step will be to propose new topics and fields of application that these changes in paradigm offer and demand from neuroscience. The false dichotomies of genes versus environment, mind versus brain, and reason versus emotion are considered, as are the new applications of neuropsychology to the understanding of psychopathological disorders, from the neurodegenerative to neurodevelopment, from 'dirty' drugs to cognitive and affective enhancers.

  19. The Ontology of Biological and Clinical Statistics (OBCS) for standardized and reproducible statistical analysis.

    Science.gov (United States)

    Zheng, Jie; Harris, Marcelline R; Masci, Anna Maria; Lin, Yu; Hero, Alfred; Smith, Barry; He, Yongqun

    2016-09-14

    Statistics play a critical role in biological and clinical research. However, most reports of scientific results in the published literature make it difficult for the reader to reproduce the statistical analyses performed in achieving those results because they provide inadequate documentation of the statistical tests and algorithms applied. The Ontology of Biological and Clinical Statistics (OBCS) is put forward here as a step towards solving this problem. The terms in OBCS including 'data collection', 'data transformation in statistics', 'data visualization', 'statistical data analysis', and 'drawing a conclusion based on data', cover the major types of statistical processes used in basic biological research and clinical outcome studies. OBCS is aligned with the Basic Formal Ontology (BFO) and extends the Ontology of Biomedical Investigations (OBI), an OBO (Open Biological and Biomedical Ontologies) Foundry ontology supported by over 20 research communities. Currently, OBCS comprehends 878 terms, representing 20 BFO classes, 403 OBI classes, 229 OBCS specific classes, and 122 classes imported from ten other OBO ontologies. We discuss two examples illustrating how the ontology is being applied. In the first (biological) use case, we describe how OBCS was applied to represent the high throughput microarray data analysis of immunological transcriptional profiles in human subjects vaccinated with an influenza vaccine. In the second (clinical outcomes) use case, we applied OBCS to represent the processing of electronic health care data to determine the associations between hospital staffing levels and patient mortality. Our case studies were designed to show how OBCS can be used for the consistent representation of statistical analysis pipelines under two different research paradigms. Other ongoing projects using OBCS for statistical data processing are also discussed. The OBCS source code and documentation are available at: https://github.com/obcs/obcs . The Ontology

  20. Clinical trials information in drug development and regulation : existing systems and standards

    NARCIS (Netherlands)

    Valkenhoef, Gert van; Tervonen, Tommi; Brock, Bert de; Hillege, Hans

    2012-01-01

    Clinical trials provide pivotal evidence on drug efficacy and safety. The evidence, information from clinical trials, is currently used by regulatory decision makers in marketing authorization decisions, but only in an implicit manner. For clinical trials information to be used in a transparent and

  1. Technological advances in perioperative monitoring: Current concepts and clinical perspectives.

    Science.gov (United States)

    Chilkoti, Geetanjali; Wadhwa, Rachna; Saxena, Ashok Kumar

    2015-01-01

    Minimal mandatory monitoring in the perioperative period recommended by Association of Anesthetists of Great Britain and Ireland and American Society of Anesthesiologists are universally acknowledged and has become an integral part of the anesthesia practice. The technologies in perioperative monitoring have advanced, and the availability and clinical applications have multiplied exponentially. Newer monitoring techniques include depth of anesthesia monitoring, goal-directed fluid therapy, transesophageal echocardiography, advanced neurological monitoring, improved alarm system and technological advancement in objective pain assessment. Various factors that need to be considered with the use of improved monitoring techniques are their validation data, patient outcome, safety profile, cost-effectiveness, awareness of the possible adverse events, knowledge of technical principle and ability of the convenient routine handling. In this review, we will discuss the new monitoring techniques in anesthesia, their advantages, deficiencies, limitations, their comparison to the conventional methods and their effect on patient outcome, if any.

  2. [Pathogenesis, clinical picture, and current therapy of rosacea].

    Science.gov (United States)

    Gonser, L I; Gonser, C E; Schaller, M

    2016-01-01

    Rosacea is a common chronic inflammatory disease, especially in patients with fair skin and positive family history. Typical locations are forehead, nose, cheeks and chin; the periorbital region is usually not involved. Clinical features can be very heterogeneous. Besides different subtypes (erythematotelangiectatic rosacea, papulopustular rosacea, phymatous rosacea), which often overlap, various special forms of rosacea exist. Up to 60% of patients with cutaneous rosacea suffer from ocular rosacea. In Germany, brimonidine, metronidazol, azelaic acid, and ivermectin are approved for topical therapy of rosacea; for systemic therapy, doxycycline at a subantimicrobial dose (40 mg/day) is the only approved substance. In case of resistance to this therapy, contraindications or side effects, various alternative therapies are available, however off-label.

  3. Clinical management of achalasia: current state of the art

    Directory of Open Access Journals (Sweden)

    Krill JT

    2016-04-01

    Full Text Available Joseph T Krill, Rishi D Naik, Michael F Vaezi Division of Gastroenterology, Hepatology, and Nutrition, Center for Swallowing and Esophageal Disorders, Vanderbilt University Medical Center, Nashville, TN, USA Abstract: Achalasia is a primary disorder of esophageal motility. It classically presents with dysphagia to both solids and liquids but may be accompanied by regurgitation and chest pain. The gold standard for the diagnosis of achalasia is esophageal motility testing with manometry, which often reveals aperistalsis of the esophageal body and incomplete lower esophageal sphincter relaxation. The diagnosis is aided by complimentary tests, such as esophagogastroduodenoscopy and contrast radiography. Esophagogastroduodenoscopy is indicated to rule out mimickers of the disease known as “pseudoachalasia” (eg, malignancy. Endoscopic appearance of a dilated esophagus with retained food or saliva and a puckered lower esophageal sphincter should raise suspicion for achalasia. Additionally, barium esophagography may reveal a dilated esophagus with a distal tapering giving it a “bird’s beak” appearance. Multiple therapeutic modalities aid in the management of achalasia, the decision of which depends on operative risk factors. Conventional treatments include medical therapy, botulinum toxin injection, pneumatic dilation, and Heller myotomy. The last two are defined as the most definitive treatment options. New emerging therapies include peroral endoscopic myotomy, placement of self-expanding metallic stents, and endoscopic sclerotherapy. Keywords: achalasia, pseudoachalasia, pneumatic dilation, Heller myotomy, botulinum toxin injection, peroral endoscopic myotomy

  4. Clinical characteristics and current therapies for inherited retinal degenerations.

    Science.gov (United States)

    Sahel, José-Alain; Marazova, Katia; Audo, Isabelle

    2014-10-16

    Inherited retinal degenerations (IRDs) encompass a large group of clinically and genetically heterogeneous diseases that affect approximately 1 in 3000 people (>2 million people worldwide) (Bessant DA, Ali RR, Bhattacharya SS. 2001. Molecular genetics and prospects for therapy of the inherited retinal dystrophies. Curr Opin Genet Dev 11: 307-316.). IRDs may be inherited as Mendelian traits or through mitochondrial DNA, and may affect the entire retina (e.g., rod-cone dystrophy, also known as retinitis pigmentosa, cone dystrophy, cone-rod dystrophy, choroideremia, Usher syndrome, and Bardet-Bidel syndrome) or be restricted to the macula (e.g., Stargardt disease, Best disease, and Sorsby fundus dystrophy), ultimately leading to blindness. IRDs are a major cause of severe vision loss, with profound impact on patients and society. Although IRDs remain untreatable today, significant progress toward therapeutic strategies for IRDs has marked the past two decades. This progress has been based on better understanding of the pathophysiological pathways of these diseases and on technological advances.

  5. Current and past strategies for bacterial culture in clinical microbiology.

    Science.gov (United States)

    Lagier, Jean-Christophe; Edouard, Sophie; Pagnier, Isabelle; Mediannikov, Oleg; Drancourt, Michel; Raoult, Didier

    2015-01-01

    A pure bacterial culture remains essential for the study of its virulence, its antibiotic susceptibility, and its genome sequence in order to facilitate the understanding and treatment of caused diseases. The first culture conditions empirically varied incubation time, nutrients, atmosphere, and temperature; culture was then gradually abandoned in favor of molecular methods. The rebirth of culture in clinical microbiology was prompted by microbiologists specializing in intracellular bacteria. The shell vial procedure allowed the culture of new species of Rickettsia. The design of axenic media for growing fastidious bacteria such as Tropheryma whipplei and Coxiella burnetii and the ability of amoebal coculture to discover new bacteria constituted major advances. Strong efforts associating optimized culture media, detection methods, and a microaerophilic atmosphere allowed a dramatic decrease of the time of Mycobacterium tuberculosis culture. The use of a new versatile medium allowed an extension of the repertoire of archaea. Finally, to optimize the culture of anaerobes in routine bacteriology laboratories, the addition of antioxidants in culture media under an aerobic atmosphere allowed the growth of strictly anaerobic species. Nevertheless, among usual bacterial pathogens, the development of axenic media for the culture of Treponema pallidum or Mycobacterium leprae remains an important challenge that the patience and innovations of cultivators will enable them to overcome. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  6. Dairy products on metabolic health: current research and clinical implications.

    Science.gov (United States)

    Da Silva, Marine S; Rudkowska, Iwona

    2014-03-01

    Dairy products have been thought to have a beneficial role in the metabolic syndrome (MetS). MetS constitutes a cluster of risk factors for an increased mortality, including obesity, impaired glucose homeostasis, hypertension and atherogenic dyslipidemia. Individuals with MetS are also often in a chronic, low-grade inflammatory state. The objective of this review is to examine recent meta-analyses and clinical studies on the association between dairy products consumption and these MetS risk factors. Findings from studies demonstrate that weight loss related to dairy product intake is due to the combination of an energy-restricted diet with consumption of dairy products. Further, a limited number of studies have shown beneficial effects of dairy consumption on plasma lipids, blood pressure, glucose homeostasis or inflammatory and oxidative stress profiles. Overall, this review article suggests that adults should consume at least 2-3 servings of dairy products per day within a well-balanced diet and a healthy lifestyle for metabolic health. Yet, higher dairy product consumption may have additional beneficial effects, but more well-designed intervention studies are needed to ascertain these effects.

  7. Current Therapeutic Cannabis Controversies and Clinical Trial Design Issues

    Science.gov (United States)

    Russo, Ethan B.

    2016-01-01

    This overview covers a wide range of cannabis topics, initially examining issues in dispensaries and self-administration, plus regulatory requirements for production of cannabis-based medicines, particularly the Food and Drug Administration “Botanical Guidance.” The remainder pertains to various cannabis controversies that certainly require closer examination if the scientific, consumer, and governmental stakeholders are ever to reach consensus on safety issues, specifically: whether botanical cannabis displays herbal synergy of its components, pharmacokinetics of cannabis and dose titration, whether cannabis medicines produce cyclo-oxygenase inhibition, cannabis-drug interactions, and cytochrome P450 issues, whether cannabis randomized clinical trials are properly blinded, combatting the placebo effect in those trials via new approaches, the drug abuse liability (DAL) of cannabis-based medicines and their regulatory scheduling, their effects on cognitive function and psychiatric sequelae, immunological effects, cannabis and driving safety, youth usage, issues related to cannabis smoking and vaporization, cannabis concentrates and vape-pens, and laboratory analysis for contamination with bacteria and heavy metals. Finally, the issue of pesticide usage on cannabis crops is addressed. New and disturbing data on pesticide residues in legal cannabis products in Washington State are presented with the observation of an 84.6% contamination rate including potentially neurotoxic and carcinogenic agents. With ongoing developments in legalization of cannabis in medical and recreational settings, numerous scientific, safety, and public health issues remain. PMID:27683558

  8. Amyotrophic lateral sclerosis: clinical features and current treatment approaches

    Directory of Open Access Journals (Sweden)

    Tuba Tulay Koca

    2015-06-01

    Full Text Available Amyotrophic lateral sclerosis also known as Lou Gehring's disease, is the most common motor neuron disease characterized by motor neuron degeneration in the primary cortex, brainstem and spinal cord. This leads to widespread paralysis, respiratory insufficiency and death within an average of 3-5 years from disease onset. Majority of cases is sporadic and only 10% have a family story. One of the most interesting discovery in the field of neurodegeneration in recent years is genetic mutation in the C9orf72 (chromosome 9 open reading frame 72 gene, the most common mutation found to be causative of frontotemporal dementia, amyotrophic lateral sclerosis and concomitant of these two diseases. Currently curative therapy for amyotrophic lateral sclerosis is lacking. To date, one medication, Riluzole, has been proved to prolong survival, approximately 3-5 months, in amyotrophic lateral sclerosis. Researches aim to slow disease progression by targeting known pathophysiological pathways or genetics defects. Only symptomatic care to improve quality of life and survival is suggested. These includes respiratory and nutrition support; dysphagia and gastrostomy management; communication and mobility programs; spasticity prevention; pain medication; management of cognitive dysfunction, depression, mood dysorders (especially apathy, fatigue, sleep disturbance and prevention of deep venous thrombosis. [Archives Medical Review Journal 2015; 24(2.000: 182-194

  9. Current trends in the cardiovascular clinical trial arena (I

    Directory of Open Access Journals (Sweden)

    Pater Cornel

    2004-06-01

    Full Text Available Abstract The existence of effective therapies for most cardiovascular disease states, coupled with increased requirements that potential benefits of new drugs be evaluated on clinical rather than surrogate endpoints, makes it increasingly difficult to substantiate any incremental improvements in efficacy that these new drugs might offer. Compounding the problem is the highly controversial issue of comparing new agents with placebos rather than active pharmaceuticals in drug efficacy trials. Despite the recent consensus that placebos may be used ethically in well-defined, justifiable circumstances, the problem persists, in part because of increased scrutiny by ethics committees but also because of considerable lingering disagreement regarding the propriety and scientific value of placebo-controlled trials (and trials of antihypertensive drugs in particular. The disagreement also substantially affects the most viable alternative to placebo-controlled trials: actively controlled equivalence/noninferiority trials. To a great extent, this situation was prompted by numerous previous trials of this type that were marked by fundamental methodological flaws and consequent false claims, inconsistencies, and potential harm to patients. As the development and use of generic drugs continue to escalate, along with concurrent pressure to control medical costs by substituting less-expensive therapies for established ones, any claim that a new drug, intervention, or therapy is "equivalent" to another should not be accepted without close scrutiny. Adherence to proper methods in conducting studies of equivalence will help investigators to avoid false claims and inconsistencies. These matters will be addressed in the third article of this three-part series.

  10. Autoimmune liver serology: Current diagnostic and clinical challenges

    Institute of Scientific and Technical Information of China (English)

    Dimitrios P Bogdanos; Pietro Invernizzi; Ian R Mackay; Diego Vergani

    2008-01-01

    Liver-related autoantibodies are crucial for the correct diagnosis and classification of autoimmune liver diseases (AiLD), namely autoimmune hepatitis types 1 and 2 (AIH-1 and 2), primary biliary cirrhosis (PBC),and the sclerosing cholangitis variants in adults and children.AIH-1 is specified by anti-nuclear antibody (ANA) and smooth muscle antibody (SMA). AIH-2 is specified by antibody to liver kidney microsomal antigen type-1 (anti-LKM1) and anti-liver cytosol type 1 (anti-LC1).SMA,ANA and anti-LKM antibodies can be present in de-novo AIH following liver transplantation.PBC is specified by antimitochondrial antibodies (AMA) reacting with enzymes of the 2-oxo-acid dehydrogenase complexes (chiefly pyruvate dehydrogenase complex E2 subunit) and disease-specific ANA mainly reacting with nuclear pore gp210 and nuclear body sp100. Sclerosing cholangitis presents as at least two variants,first the classical primary sclerosing cholangitis (PSC) mostly affecting adult men wherein the only (and nonspecific) reactivity is an atypical perinuclear antineutrophil cytoplasmic antibody (p-ANCA),also termed perinuclear anti-neutrophil nuclear antibodies (p-ANNA) and second the childhood disease called autoimmune sclerosing cholangitis (ASC) with serological features resembling those of type 1 AIH.Liver diagnostic serology is a fast-expanding area of investigation as new purified and recombinant autoantigens,and automated technologies such as ELISAs and bead assays,become available to complement (or even compete with) traditional immunofluorescence procedures.We survey for the first time global trends in quality assurance impacting as it does on (1) manufacturers/purveyors of kits and reagents,(2) diagnostic service laboratories that fulfill clinicians'requirements, and (3) the end-user,the physician providing patient care,who must properly interpret test results in the overall clinical context.

  11. Accuracy of the Clinical Diagnosis of Vaginitis Compared to a DNA Probe Laboratory Standard

    Science.gov (United States)

    Lowe, Nancy K.; Neal, Jeremy L.; Ryan-Wenger, Nancy A.

    2009-01-01

    Objective To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared to a DNA probe laboratory standard. Methods This prospective clinical comparative study had a sample of 535 active duty United States military women presenting with vulovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. Results The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis; 83.8% and 84.8% for candidiasis vaginitis; and 84.6% and 99.6% for trichomoniasis vaginalis when compared to the DNA probe standard. Conclusion Compared to a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70- 99% specific for bacterial vaginosis, candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and therefore, subsequent treatment of these common vaginal problems remains difficult. PMID:19104364

  12. The dark matter crisis: falsification of the current standard model of cosmology

    CERN Document Server

    Kroupa, Pavel

    2012-01-01

    The current standard model of cosmology (SMoC) requires The Dual Dwarf Galaxy Theorem to be true. According to this theorem two types of dwarf galaxies must exist: primordial dark-matter (DM) dominated (type A) dwarf galaxies, and tidal-dwarf and ram-pressure-dwarf (type B) galaxies void of DM. In the model, type A dwarfs are distributed approximately spherically following the shape of the host galaxy DM halo, while type B dwarfs are typically correlated in phase-space. Type B dwarfs must exist in any cosmological theory in which galaxies interact. Only one type of dwarf galaxy is observed to exist on the baryonic Tully-Fisher plot and in the radius-mass plane. The Milky Way satellite system forms a vast phase-space-correlated structure that includes globular clusters and stellar and gaseous streams. Similar arguments apply to Andromeda. Other galaxies also have phase-space correlated satellite systems. Therefore, The Dual Galaxy Theorem is falsified by observation and dynamically relevant cold or warm DM on ...

  13. Taper Preparation Variability Compared to Current Taper Standards Using Computed Tomography

    Directory of Open Access Journals (Sweden)

    Richard Gergi

    2012-01-01

    Full Text Available Introduction. The purpose of this study was to compare the taper variation in root canal preparations among Twisted Files and PathFiles-ProTaper .08 tapered rotary files to current standards. Methods. 60 root canals with severe angle of curvature (between 25∘ and 35∘ and short radius (<10 mm were selected. The canals were divided randomly into two groups of 30 each. After preparation with Twisted Files and PathFiles-ProTaper to size 25 taper .08, the diameter was measured using computed tomography (CT at 1, 3, and 16 mm. Canal taper preparation was calculated at the apical third and at the middle-cervical third. Results. Of the 2 file systems, both fell within the ±.05 taper variability. All preparations demonstrated variability when compared to the nominal taper .08. In the apical third, mean taper was significantly different between TF and PathFiles-ProTaper ( value < 0.0001; independent -test. Mean Taper was significantly higher with PathFile-ProTaper. In the middle-cervical third, mean Taper was significantly higher with TF ( value = 0.015; independent -test. Conclusion. Taper preparations of the investigated size 25 taper .08 were favorable but different from the nominal taper.

  14. Comparison and Analysis of the Reference Intervals of 9 Serum Routine Chemical Analytes between the Current Application of Clinical Laboratories and the Latest Health Industrial Standards Draft for Approval%国内临床化学9项常规项目参考区间与即将发布的卫生行业标准的比较和分析

    Institute of Scientific and Technical Information of China (English)

    钟堃; 王薇; 何法霖; 王治国

    2015-01-01

    .1% (31/36)].Only a few of laboratories’reference interval had been grouped (approximately 20%).There were some differences in grouping rules between laboratories and standards.Even though some of the laboratories adopt the grouping rules as same as the standards,there were still big differences in reference intervals between the laboratories and the stand-ards[t=-39.365~13.155,P <0.01,62.5% (10/16)].Conclusion The reference intervals of routine chemistry analytes suggested by the health industry standards draft for approval had quite big differences from the reference intervals used in current clinical laboratories daily work.It is important to propel the authority health industry standards to use in the daily work of clinical laboratories.The evaluation and validation of using them should be done first.

  15. XBRL Standard for Financial Reporting in Croatia: Current State and Perspectives

    Directory of Open Access Journals (Sweden)

    Gostimir Dejan

    2015-09-01

    Full Text Available Background: Harmonization and standardization is becoming important among regulators and business community. XBRL has entered the global stage as a financial reporting standard. Its mission was to standardize the financial reporting, lower the reporting costs and make the reporting as transparent as possible.

  16. NODC Standard Format Current Meter (Components) (F015) Data (1962-1992) (NCEI Accession 0066358)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This data set contains time series measurements of ocean currents. These data are obtained from current meter moorings and represent the Eulerian method of current...

  17. Chemotherapeutic strategies in metastatic colorectal cancer: an overview of current clinical trials.

    Science.gov (United States)

    Köhne-Wömpner, C H; Schmoll, H J; Harstrick, A; Rustum, Y M

    1992-04-01

    5-Fluorouracil (5-FU) is still the mainstay of chemotherapy in patients with metastatic colorectal cancer. A prolonged infusion of 5-FU is more active than any other schedule of 5-FU used to date. Cisplatin does not improve treatment results compared with 5-FU alone and is not recommended outside clinical trials. Biomodulation of 5-FU is a major step forward in the treatment of colorectal cancer patients and as the standard chemotherapy for advanced colorectal cancer. Two schedules of folinic acid daily for 5-day (low and high doses) and weekly high dose in combination with daily or weekly 5-FU are the most widely used schedules. Although the response rates to either schedule are comparable, the profile of toxicity is different, being stomatitis for the daily schedule and diarrhea for the weekly schedule as the dose-limiting toxicity. Modulation of 5-FU by methotrexate is time dependent. An interval of 24 hours between methotrexate and 5-FU is necessary for effective modulation. Other modulators, like interferon and N-phosphonoactyl-L-aspartate (PALA), are promising treatment options currently under investigation in randomized trials. The data from phase II and III trials using modulation of 5-FU by folinic acid, PALA, or methotrexate, or using continuous infusion 5-FU indicate that all of these strategies are active. Randomized trials are currently underway to further investigate these therapeutic approaches and whether a specific modulation offers more therapeutic advantages.

  18. Addiction Competencies in the 2009 CACREP Clinical Mental Health Counseling Program Standards

    Science.gov (United States)

    Lee, Tiffany K.; Craig, Stephen E.; Fetherson, Bianca T. L.; Simpson, C. Dennis

    2013-01-01

    The Council for Accreditation of Counseling and Related Educational Programs developed addiction competencies for clinical mental health counseling students. This article highlights these competencies, provides an overview of current addiction training, and describes methods to integrate addiction education into curricula.

  19. Addiction Competencies in the 2009 CACREP Clinical Mental Health Counseling Program Standards

    Science.gov (United States)

    Lee, Tiffany K.; Craig, Stephen E.; Fetherson, Bianca T. L.; Simpson, C. Dennis

    2013-01-01

    The Council for Accreditation of Counseling and Related Educational Programs developed addiction competencies for clinical mental health counseling students. This article highlights these competencies, provides an overview of current addiction training, and describes methods to integrate addiction education into curricula.

  20. American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards.

    Science.gov (United States)

    Jacobson, Joseph O; Polovich, Martha; McNiff, Kristen K; LeFebvre, Kristine B; Cummings, Charmaine; Galioto, Michele; Bonelli, Katherine R; McCorkle, Michele R

    2009-11-01

    Standardization of care can reduce the risk of errors, increase efficiency, and provide a framework for best practice. In 2008, the American Society of Clinical Oncology (ASCO) and the Oncology Nursing Society (ONS) invited a broad range of stakeholders to create a set of standards for the administration of chemotherapy to adult patients in the outpatient setting. At the close of a full-day structured workshop, 64 draft standards were proposed. After a formal process of electronic voting and conference calls, 29 draft standards were eliminated, resulting in a final list of 35 draft measures. The proposed set of standards was posted for 6 weeks of open public comment. Three hundred twenty-two comments were reviewed by the Steering Group and used as the basis for final editing to a final set of standards. The final list includes 31 standards encompassing seven domains, which include the following: review of clinical information and selection of a treatment regimen; treatment planning and informed consent; ordering of treatment; drug preparation; assessment of treatment compliance; administration and monitoring; assessment of response and toxicity monitoring. Adherence to ASCO and ONS standards for safe chemotherapy administration should be a goal of all providers of adult cancer care.

  1. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    Osteoarthritis (OA) is a heterogeneous disorder. The goals of this review are (1) To stimulate use of standardized nomenclature for OA that could serve as building blocks for describing OA and defining OA phenotypes, in short to provide unifying disease concepts for a heterogeneous disorder; and (2...

  2. Cost-effectiveness analysis of sofosbuvir compared to current standard treatment in Swiss patients with chronic hepatitis C.

    Directory of Open Access Journals (Sweden)

    Alena M Pfeil

    Full Text Available In clinical trials, sofosbuvir showed high antiviral activity in patients infected with hepatitis C virus (HCV across all genotypes. We aimed to determine the cost-effectiveness of sofosbuvir-based treatment compared to current standard treatment in mono-infected patients with chronic hepatitis C (CHC genotypes 1-4 in Switzerland. Cost-effectiveness was modelled from the perspective of the Swiss health care system using a lifetime Markov model. Incremental cost-effectiveness ratios (ICERs used an endpoint of cost per quality-adjusted life year (QALY gained. Treatment characteristics, quality of life, and transition probabilities were obtained from published literature. Country-specific model inputs such as patient characteristics, mortality and costs were obtained from Swiss sources. We performed extensive sensitivity analyses. Costs and effects were discounted at 3% (range: 0-5% per year. Sofosbuvir-containing treatment in mixed cohorts of cirrhotic and non-cirrhotic patients with CHC genotypes 1-4 showed ICERs between CHF 10,337 and CHF 91,570 per QALY gained. In subgroup analyses, sofosbuvir dominated telaprevir- and boceprevir-containing treatment in treatment-naïve genotype 1 cirrhotic patients. ICERs of sofosbuvir were above CHF 100,000 per QALY in treatment-naïve, interferon eligible, non-cirrhotic patients infected with genotypes 2 or 3. In deterministic and probabilistic sensitivity analyses, results were generally robust. From a Swiss health care system perspective, treatment of mixed cohorts of cirrhotic and non-cirrhotic patients with CHC genotypes 1-4 with sofosbuvir-containing treatment versus standard treatment would be cost-effective if a threshold of CHF 100,000 per QALY was assumed.

  3. Cost-effectiveness analysis of sofosbuvir compared to current standard treatment in Swiss patients with chronic hepatitis C.

    Science.gov (United States)

    Pfeil, Alena M; Reich, Oliver; Guerra, Ines M; Cure, Sandrine; Negro, Francesco; Müllhaupt, Beat; Lavanchy, Daniel; Schwenkglenks, Matthias

    2015-01-01

    In clinical trials, sofosbuvir showed high antiviral activity in patients infected with hepatitis C virus (HCV) across all genotypes. We aimed to determine the cost-effectiveness of sofosbuvir-based treatment compared to current standard treatment in mono-infected patients with chronic hepatitis C (CHC) genotypes 1-4 in Switzerland. Cost-effectiveness was modelled from the perspective of the Swiss health care system using a lifetime Markov model. Incremental cost-effectiveness ratios (ICERs) used an endpoint of cost per quality-adjusted life year (QALY) gained. Treatment characteristics, quality of life, and transition probabilities were obtained from published literature. Country-specific model inputs such as patient characteristics, mortality and costs were obtained from Swiss sources. We performed extensive sensitivity analyses. Costs and effects were discounted at 3% (range: 0-5%) per year. Sofosbuvir-containing treatment in mixed cohorts of cirrhotic and non-cirrhotic patients with CHC genotypes 1-4 showed ICERs between CHF 10,337 and CHF 91,570 per QALY gained. In subgroup analyses, sofosbuvir dominated telaprevir- and boceprevir-containing treatment in treatment-naïve genotype 1 cirrhotic patients. ICERs of sofosbuvir were above CHF 100,000 per QALY in treatment-naïve, interferon eligible, non-cirrhotic patients infected with genotypes 2 or 3. In deterministic and probabilistic sensitivity analyses, results were generally robust. From a Swiss health care system perspective, treatment of mixed cohorts of cirrhotic and non-cirrhotic patients with CHC genotypes 1-4 with sofosbuvir-containing treatment versus standard treatment would be cost-effective if a threshold of CHF 100,000 per QALY was assumed.

  4. Occupational health impacts of climate change: current and future ISO standards for the assessment of heat stress.

    Science.gov (United States)

    Parsons, Ken

    2013-01-01

    The current system of International Standards (ISO) is assessed to consider whether standards are fit for purpose for the future in the context of climate change. ISO 7243, ISO 7933 and ISO 9886 provide the current ISO system for the assessment of heat stress. These involve a simple monitoring index, an analytical approach and physiological monitoring, respectively. The system relies on accurate measurement of the thermal conditions experienced by the worker (ISO 7726); and estimations of metabolic heat production due to work (ISO 8996) and the thermal properties of clothing (ISO 9920). As well as standards for heat stress assessment, the full range of ISO standards and the physical environment is listed as well as current work and proposed standards. A particular 'gap' in anticipating requirements for ISO standards in the future is the link between meteorological data and ISO standards. This is important for predicting the global consequences of a changing climate and anticipating potential impacts on occupational health across countries and cultures.

  5. The standardized patient encounter: a dynamic educational approach to enhance students' clinical healthcare skills.

    Science.gov (United States)

    Herge, E Adel; Lorch, Arlene; Deangelis, Tina; Vause-Earland, Tracey; Mollo, Kimberly; Zapletal, Audrey

    2013-01-01

    Occupational therapy educators are challenged to prepare students entering the profession to be skilled in assessment, critical thinking, self-analysis, and decision-making. Simulation is an effective strategy used in medical and nursing curriculums to develop or enhance critical thinking, self-analysis, and decision-making skills. Through simulated learning activities, such as encounters with standardized patients (SP), students develop skills in decision-making, clinical reasoning, and interpersonal communication, skills necessary to function effectively in the current health care environment. This paper describes the process for integrating SP encounters in a professional healthcare curriculum for occupational therapy graduate students. Evidence that supports the use of simulation in healthcare curriculums for health profession students is explored. An example of an SP encounter in one occupational therapy course is described to illustrate how students engage in higher-level thinking as they administer an assessment tool and interact with an SP. The process of developing and evaluating the SP encounter is described and the outcomes are presented. The authors believe the SP experience is a viable teaching method in preparing competent, reflective practitioners for tomorrow's healthcare environment.

  6. Excerpts from the 1st international NTNU symposium on current and future clinical biomarkers of cancer

    DEFF Research Database (Denmark)

    Robles, Ana I; Olsen, Karina Standahl; Tsui, Dana W T;

    2016-01-01

    The goal of biomarker research is to identify clinically valid markers. Despite decades of research there has been disappointingly few molecules or techniques that are in use today. The "1st International NTNU Symposium on Current and Future Clinical Biomarkers of Cancer: Innovation and Implement......The goal of biomarker research is to identify clinically valid markers. Despite decades of research there has been disappointingly few molecules or techniques that are in use today. The "1st International NTNU Symposium on Current and Future Clinical Biomarkers of Cancer: Innovation...

  7. Device and methods for "gold standard" registration of clinical 3D and 2D cerebral angiograms

    Science.gov (United States)

    Madan, Hennadii; Likar, Boštjan; Pernuš, Franjo; Å piclin, Žiga

    2015-03-01

    Translation of any novel and existing 3D-2D image registration methods into clinical image-guidance systems is limited due to lack of their objective validation on clinical image datasets. The main reason is that, besides the calibration of the 2D imaging system, a reference or "gold standard" registration is very difficult to obtain on clinical image datasets. In the context of cerebral endovascular image-guided interventions (EIGIs), we present a calibration device in the form of a headband with integrated fiducial markers and, secondly, propose an automated pipeline comprising 3D and 2D image processing, analysis and annotation steps, the result of which is a retrospective calibration of the 2D imaging system and an optimal, i.e., "gold standard" registration of 3D and 2D images. The device and methods were used to create the "gold standard" on 15 datasets of 3D and 2D cerebral angiograms, whereas each dataset was acquired on a patient undergoing EIGI for either aneurysm coiling or embolization of arteriovenous malformation. The use of the device integrated seamlessly in the clinical workflow of EIGI. While the automated pipeline eliminated all manual input or interactive image processing, analysis or annotation. In this way, the time to obtain the "gold standard" was reduced from 30 to less than one minute and the "gold standard" of 3D-2D registration on all 15 datasets of cerebral angiograms was obtained with a sub-0.1 mm accuracy.

  8. Predicting the efficacy of trastuzumab-based therapy in breast cancer: current standards and future strategies.

    Science.gov (United States)

    Singer, Christian F; Köstler, Wolfgang J; Hudelist, Gernot

    2008-12-01

    Breast cancer is the most common female malignancy in many industrialized countries. Approximately one fourth of all women diagnosed with early breast cancer present with tumors that are characterized by erbB2 amplification. While the associated Her-2/neu receptor overexpression results in a high risk of relapse and poor prognosis, these tumors also represent a target for a selective monoclonal antibody therapy with trastuzumab (Herceptin). The combination of trastuzumab with chemotherapy has led to a considerable reduction of recurrences and to a significant reduction in breast cancer mortality both in the adjuvant and metastatic setting. Unfortunately, despite Her-2/neu overexpression, not all patients equally benefit from trastuzumab treatment, and almost all women with metastatic breast cancer eventually progress during antibody therapy. Moreover, trastuzumab is burdened with cardiotoxicity, thus increasing the risk of symptomatic congestive heart failure. In addition, the marginal costs for a 1 year therapy of trastuzumab-based therapy, which is currently considered to be the most effective treatment regimen in the adjuvant setting, may amount for up to US$ 40.000. Testing for erbB2 oncogene amplification by fluorescence in situ hybridization (FISH) and chromogenic in situ hybridization (CISH), respectively, and staining for Her-2/neu receptor overexpression by immunohistochemistry (IHC) represent the current standard for determining patient eligibility for trastuzumab-based therapy. However, while the negative predictive value of these assays for predicting the absence of benefit from trastuzumab-based therapy is sufficiently high, their positive predictive value remains insufficient, i.e. only a proportion of patients selected by these tests substantially benefit from trastuzumab-containing regimen. Accordingly, over the last years a number of biomarkers have been evaluated in their potential to predict response to trastuzumab-based therapies. These include

  9. Methodological aspects of clinical trials in tinnitus: A proposal for an international standard

    Science.gov (United States)

    Landgrebe, Michael; Azevedo, Andréia; Baguley, David; Bauer, Carol; Cacace, Anthony; Coelho, Claudia; Dornhoffer, John; Figueiredo, Ricardo; Flor, Herta; Hajak, Goeran; van de Heyning, Paul; Hiller, Wolfgang; Khedr, Eman; Kleinjung, Tobias; Koller, Michael; Lainez, Jose Miguel; Londero, Alain; Martin, William H.; Mennemeier, Mark; Piccirillo, Jay; De Ridder, Dirk; Rupprecht, Rainer; Searchfield, Grant; Vanneste, Sven; Zeman, Florian; Langguth, Berthold

    2013-01-01

    Chronic tinnitus is a common condition with a high burden of disease. While many different treatments are used in clinical practice, the evidence for the efficacy of these treatments is low and the variance of treatment response between individuals is high. This is most likely due to the great heterogeneity of tinnitus with respect to clinical features as well as underlying pathophysiological mechanisms. There is a clear need to find effective treatment options in tinnitus, however, clinical trials differ substantially with respect to methodological quality and design. Consequently, the conclusions that can be derived from these studies are limited and jeopardize comparison between studies. Here, we discuss our view of the most important aspects of trial design in clinical studies in tinnitus and make suggestions for an international methodological standard in tinnitus trials. We hope that the proposed methodological standard will stimulate scientific discussion and will help to improve the quality of trials in tinnitus. PMID:22789414

  10. [The challenges of standardization in clinical diagnostic laboratories of medical organizations].

    Science.gov (United States)

    Men'shikov, V V

    2013-04-01

    The generalized data concerning the conditions of application of regulations of national standards in clinical diagnostic laboratories of medical organizations is presented. The primary information was provided by 14 regions of 6 federal administrative okrugs of Russia. The causes of challenges of application of requirements of standards are presented. They are mostly related with insufficient financial support, lacking of manpower, difficulties with reagents supply, inadequate technical maintenance of devices and absence of support of administration of medical organizations. The recommendations are formulated concerning the necessity of publishing the document of Minzdrav of Russia to determine the need in application of standards in laboratory practice.

  11. The National Instructional Materials Accessibility Standard (NIMAS): Current State Implementation. inForum

    Science.gov (United States)

    Muller, Eve; Burdette, Paula

    2007-01-01

    As part of the 2004 reauthorization of the Individuals with Disabilities Education Act (IDEA), states are required to comply with the National Instructional Materials Accessibility Standard (NIMAS) beginning July 19, 2006. NIMAS is defined as "the standard established by the Secretary to be used in the preparation of electronic files suitable…

  12. NODC Standard Product: Ocean current drifter data (2 disc set) (NODC Accession 0098060)

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — These CD-ROMs hold over 4 million surface current observations, almost all obtained by the ship drift method. Date, data source, position, and current direction and...

  13. Good Laboratory Standards for Clinical Next-Generation Sequencing Cancer Panel Tests

    Directory of Open Access Journals (Sweden)

    Jihun Kim

    2017-05-01

    Full Text Available Next-generation sequencing (NGS has recently emerged as an essential component of personalized cancer medicine due to its high throughput and low per-base cost. However, no sufficient guidelines for implementing NGS as a clinical molecular pathology test are established in Korea. To ensure clinical grade quality without inhibiting adoption of NGS, a taskforce team assembled by the Korean Society of Pathologists developed laboratory guidelines for NGS cancer panel testing procedures and requirements for clinical implementation of NGS. This consensus standard proposal consists of two parts: laboratory guidelines and requirements for clinical NGS laboratories. The laboratory guidelines part addressed several important issues across multistep NGS cancer panel tests including choice of gene panel and platform, sample handling, nucleic acid management, sample identity tracking, library preparation, sequencing, analysis and reporting. Requirements for clinical NGS tests were summarized in terms of documentation, validation, quality management, and other required written policies. Together with appropriate pathologist training and international laboratory standards, these laboratory standards would help molecular pathology laboratories to successfully implement NGS cancer panel tests in clinic. In this way, the oncology community would be able to help patients to benefit more from personalized cancer medicine.

  14. Current Climate Data Set Documentation Standards: Somewhere between Anagrams and Full Disclosure

    Science.gov (United States)

    Fleig, A. J.

    2008-12-01

    techniques are being developed that will simplify the creation of much of the provenance information but there are both cultural and infrastructure problems that discourage provision of complete documentation. It is time to reconsider what the standards for production and documentation of data sets should be. There is only a short window before the loss of knowledge about current data sets associated with human mortality becomes irreversible. .

  15. Capsaicin: Current Understanding of Its Mechanisms and Therapy of Pain and Other Pre-Clinical and Clinical Uses

    Directory of Open Access Journals (Sweden)

    Victor Fattori

    2016-06-01

    Full Text Available In this review, we discuss the importance of capsaicin to the current understanding of neuronal modulation of pain and explore the mechanisms of capsaicin-induced pain. We will focus on the analgesic effects of capsaicin and its clinical applicability in treating pain. Furthermore, we will draw attention to the rationale for other clinical therapeutic uses and implications of capsaicin in diseases such as obesity, diabetes, cardiovascular conditions, cancer, airway diseases, itch, gastric, and urological disorders.

  16. Quality standards for DNA sequence variation databases to improve clinical management under development in Australia

    Directory of Open Access Journals (Sweden)

    B. Bennetts

    2014-09-01

    Full Text Available Despite the routine nature of comparing sequence variations identified during clinical testing to database records, few databases meet quality requirements for clinical diagnostics. To address this issue, The Royal College of Pathologists of Australasia (RCPA in collaboration with the Human Genetics Society of Australasia (HGSA, and the Human Variome Project (HVP is developing standards for DNA sequence variation databases intended for use in the Australian clinical environment. The outputs of this project will be promoted to other health systems and accreditation bodies by the Human Variome Project to support the development of similar frameworks in other jurisdictions.

  17. The Influences of Student and Standardized Patient Genders on Scoring an Objective Structured Clinical Examination.

    Science.gov (United States)

    Rutala, Paul J.; And Others

    1991-01-01

    A study investigating possible sex bias, concerning both student and standardized-patient genders, in an objective structured clinical examination found that neither men nor women were afforded an advantage by patient or test location. However, women's scores on tests administered by females were higher than corresponding men's scores. (MSE)

  18. Detection of dermatological abnormalities in the rheumatology clinic using a standardized screening exam.

    Science.gov (United States)

    Wong, Newton Wai Kwan; Towheed, Tanveer Ezad; Hopman, Wilma; Kirchhof, Mark Gajda

    2017-06-14

    To develop a standardized practical screening tool for rheumatologists to assess for underlying dermatological manifestations of rheumatic conditions. A relevant screening tool was developed by consensus between dermatology and rheumatology authors. Patients visiting the general rheumatology clinic for routine care were systematically assessed based on the standardized screening tool. One hundred patients were recruited with 76 being female. The most prevalent rheumatic conditions seen in the clinic were rheumatoid arthritis, psoriatic arthritis and systemic lupus erythematosus. The standardized integumentary assessment took a mean of 2.75 (SD 1.61) min. Most patients, 74%, reported no concerns with their hair or nails, while 60% reported no concerns with their skin. The majority of patients had one abnormality identified, 65%, and of those diagnoses, most affected the skin with 71% of patients having an identified skin abnormality, compared with the hair (10%) or nails (13%). The standardized integumentary assessment tool can be successfully incorporated into routine clinical practice for rheumatologists without significant extension of consultation time and may detect relevant abnormalities important for diagnosis which may have been unnoticed by patients. It may encourage collaborative care and enhance clinical outcomes. © 2017 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.

  19. Standardized Patient Encounters Improved Athletic Training Students' Confidence in Clinical Evaluations

    Science.gov (United States)

    Armstrong, Kirk J.; Jarriel, Amanda J.

    2015-01-01

    Context: Researchers have reported that interacting with standardized patients (SPs) is a worthwhile and realistic experience for athletic training (AT) students. These encounters enhance students' interviewing skills, confidence as a clinician, clinical skill development, and interpersonal communication. Objective: To determine how SP encounters…

  20. Surveying technologists: a novel method for establishing productivity standards in a clinical haematology laboratory.

    Science.gov (United States)

    Jatoi, A; Jaromin, R; Grzybek, D; Nguyen, P L

    1997-01-01

    Personnel costs comprise the largest clinical laboratory expense. Yet standards to judge the productivity of personnel have not been established. A survey of the authors' own personnel was conducted to derive productivity standards in the Clinical Hematology Laboratory at the Massachusetts General Hospital, Boston, Massachusetts, USA. Technologists were asked how many white blood cell differentials they could perform in an eight-hour shift. Differential productivity was tracked before and after the survey. Of the respondents, 100 per cent failed to meet their own expectations of productivity. Nine technologists were tracked both before and after the survey was mailed and manifested a significant increase in productivity. These results suggest that technologists are objective in their assessment of their own productivity, that their opinions might be a resource for establishing productivity standards within the laboratory, and that such surveys may serve as motivational tools to augment productivity.

  1. Globalization of cardiovascular clinical research: the balance between meeting medical needs and maintaining scientific standards.

    Science.gov (United States)

    Stough, Wendy Gattis; Zannad, Faiez; Pitt, Bertram; Goldstein, Sidney

    2007-08-01

    A substantial need to conduct research studies and identify effective treatments for cardiovascular diseases in the developing world exists. Careful consideration of several issues is warranted to ensure that clinical trials conducted solely in developing nations are held to accepted scientific standards. Researchers conducting clinical trials in developing countries should critically evaluate the purpose and appropriateness of conducting the trial in the proposed location, the accessibility of the therapy if proven effective, the quality of the informed consent process, the presence of infrastructure to support clinical research, and the translation of data to other populations. This article discusses the importance of these considerations using a recent example of a clinical trial conducted in a developing nation. These and other issues are critical to address as the conduct of cardiovascular clinical trials continues to expand beyond the western world.

  2. Re: Current Standard Technique for Modern Flexible Ureteroscopy: Tips and Tricks

    Directory of Open Access Journals (Sweden)

    Selçuk Keskin

    2016-09-01

    Full Text Available The prevalence of urinary stone disease is increasing worldwide. The dissemination of the clinical use of ultrasound has improved the diagnosis of stones at an earlier stage. It has increased the expansion of the indications of flexible ureterorenoscopy (fURS. With the advances in flexible ureteroscopy (FU, more successful outcomes are being reported. The most recent EAU guidelines state that for all stones smaller than 2 cm, fURS can be the first choice of treatment. Especially for lower pole stones, the stone free rate is better than that with extracorporeal shock wave lithotripsy. For stones larger than 2 cm staged procedures may be necessary. This paper recommends a standardized technique for fURS to decrease the rate of possible complications, and increase the success rate. Endourological techniques are widely adopted by most of the urological surgeons, hence fURS is an expansion of our surgical armamentarium. In this paper, an experienced group recommends some tips and tricks for each step of the procedure. The authors recommend general anesthesia over spinal anesthesia for two reasons: larger tidal volume during spinal anesthesia may cause movement, which can make the procedure harder. Secondly, the duration of the spinal anesthesia may be too short for some cases. The placement of ureteral access sheath (UAS should be done under fluoroscopic guidance and proper force should be applied. Ideally, the distal tip of the UAS should be just below the ureteropelvic junction. For preventing functional deterioration of the FU, the tip of the laser probe should be out of the scope as far as one-quarter of the screen diameter. For preventing excessive prolonged deflections, the stones in the lower pole should be repositioned in order to allow a more straight working channel. Pulverization of the stone is preferred over fragmentation since it decreases the operation time and risk of injury during removal of fragments. A power setting of low

  3. Re: Current Standard Technique for Modern Flexible Ureteroscopy: Tips and Tricks

    Directory of Open Access Journals (Sweden)

    Emre Selçuk Keskin

    2016-12-01

    Full Text Available EDITORIAL COMMENT The prevalence of urinary stone disease is increasing worldwide. The dissemination of the clinical use of the ultrasound has increased the rate of diagnosis of stones at an earlier stage, thus, has increased the expansion of the indications for flexible ureterorenoscopy (fURS. With the advancements in flexible ureteroscopy (FU, more successful outcomes are being reported. The most recent EAU guidelines state that fURS can be the first choice of treatment for all stones smaller than 2 cm. Especially for the lower pole stones, the stone-free rate is better than that with extracorporeal shock wave lithotripsy. For stones larger than 2 cm, staged procedures may be necessary. This paper recommends a standardized technique for fURS which is aimed to decrease the rate of possible complications and increase the success rate. Endourological techniques are widely adopted by most of the urological surgeons, hence fURS is an expansion of our surgical armamentarium. In this paper, an experienced group recommended some tips and tricks for each step of the procedure. The authors recommended general anesthesia over spinal anesthesia for two reasons: larger tidal volume during spinal anesthesia may cause movement, which can make the procedure harder. Secondly, the duration of the spinal anesthesia may be too short for some cases. Placement of ureteral access sheath (UAS should be done under fluoroscopic guidance and proper force should be applied. Ideally, the distal tip of the UAS should be just below the ureteropelvic junction. For preventing functional deterioration of the FU, the tip of the laser probe should be out of the scope as far as one-quarter of the screen diameter. For preventing excessive prolonged deflections, the stones in the lower pole should be repositioned in order to allow a more straight working channel. Pulverization of the stone is preferred over fragmentation since it decreases the operative time and risk of injury

  4. CURRENT SITUATION INHARMONIZATION OF TURKISH ACCOUNTING STANDARDS TO THE INTERNATIONAL ACOUNTINGSTANDARDS IN EUROPEAN UNION PROCESS

    Directory of Open Access Journals (Sweden)

    Murat KORKMAZ

    2012-06-01

    Full Text Available With the ending of the coldwar period, all world countries opened their countries to the foreign investorswith the purpose of having more share from the welfare all over the world, andthey even began to apply incentives encouraging investors to invest in their countries.Within this process which is called globalization, the most important factorfor investors to invest in these countries is that financial statements shouldbe prepared in accordance with the criteria accepted all over the world. With thispurpose, world accounting association gives utmost importance to thepreparation of accounting standards as related to the preparation of financialstatements. In recent years, significant developments have been experienced inthis field in Turkey due to both European Union process and pressures of globalizingTurkish investors. Firstly, International Accounting Standards were harmonizedwith the Turkish Accounting System and then they started to be applied asTurkish Accounting Standards. As depending on the last seen world economiccrisis, studies of harmonization of the changes in these standards with TurkishAccounting System continue. In this study, to which degree these rules appliedas a standard all over the world are tried to be applied in Turkey has beenanalyzed.

  5. 75 FR 22150 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-04-27

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies Correction In notice...

  6. Historical Development of NATO Stanag 6001 Language Standards and Common European Framework (CEF) and the Comparison of Their Current Status

    Science.gov (United States)

    Solak, Ekrem

    2011-01-01

    The aim of the article is to shed light on the historical development of language studies in military and social context and to compare the current status of NATO Stanag (Standard Agreement) 6001 language scale with Common European Framework (CEF). Language studies in military context date back to World War II and the emergence of Army Specialized…

  7. 我国乳品标准体系现状%Current Status of China s Dairy Product Standards System

    Institute of Scientific and Technical Information of China (English)

    幸汐媛; 李江华

    2011-01-01

    近年来乳品安全事件频繁发生,本文通过介绍我国乳品标准体系的发展和乳品标准体系的特点,对我国现行的在奶畜养殖环节、生产加工环节和流通环节的乳品国家标准、行业标准进行相关阐述,分析我国乳品标准体系的现状。%Dairy safety incidents occur frequently in recent years.This article introduces the development and features of China s dairy product standards system,and summarizes and analyzes the current national and industrial standards for dairy products concerning cow breeding,production,processing,and circulation.Meanwhile,a review of the current status of China s dairy product standards system is provided.

  8. THE CURRENT STATE OF APPLICATION OF INTERNATIONAL FINANCIAL REPORTING STANDARDS IN UKRAINE.

    Directory of Open Access Journals (Sweden)

    B. Zasadnyi

    2016-09-01

    Full Text Available The article analyzed the process of reforming the system of accounting and reporting in Ukraine in accordance with International Financial Reporting Standards. The main results of the tasks of the Strategy of application IFRS in Ukraine approved by the Cabinet of Ministers of Ukraine in 2007 are identified. The results of analysis showed that only 1% of the total number of enterprises form the financial statements in accordance with IFRS, the others apply national standards of accounting. The proportion of small enterprises is 95% that do not have the financial capacity, qualified staff and the necessary motivation for the formation of financial statements in accordance with IFRS. As a result, one of the main objectives of the reform of the accounting and reporting is to improve the legislation on accounting for small enterprises and develop national accounting standards of the simplified procedure for accounting of assets, liabilities, equity and financial results of the calculation for small enterprises.

  9. State standards for domestic violence perpetrator treatment: current status, trends, and recommendations.

    Science.gov (United States)

    Maiuro, Roland D; Eberle, Jane A

    2008-01-01

    We empirically surveyed and analyzed existing standards for the treatment of perpetrators of domestic violence across the United States. Specific areas examined included: presence and scope; administrative entity for certifying; screening and risk assessment protocols; minimum length of treatment; theoretical or conceptual orientation; treatment content; preferred or allowable modalities of treatment; whether research findings are mentioned; methods for revising standards; and minimum education and training required for providers. We examined trends using several methods including comparisons between present and previous survey data (Maiuro et al., 2001). Positive trends were evident including increased use of multivariate models of treatment content, use of an intake assessment prior to treatment, use of a danger/lethality assessment to manage risk, recognition of the need for program evaluation and supportive research, and the requirement of a minimum level of formal education as a prerequisite for providers. We identify specific areas for further research and development and make recommendations for improving existing practice and standards of care.

  10. [The clinical effectiveness of the application of interferential currents for the combined treatment of onychopathies associated with psoriasis and eczema].

    Science.gov (United States)

    Nemchaninova, O B; Lykova, S G; Pozdnyakova, O N; Reshetnikova, T B; Makhnovets, E N; Simonova, E P; Spitsyna, A V

    2016-01-01

    The frequency of the development of clinically significant changes in the nail plates was estimated in the present study that included 454 patients presenting with psoriasis and 140 patients with eczema characterized by the localization of the pathological process on the skin of the wrists and/or feet. The changes in the nail plates were shown to occur in 56,2% of the patients with psoriasis and in 90,7% of those suffering from eczema. The capillaroscopy of the microvessels feeding the affected nails was carried out to determine the type of the capillaroscopic picture. The patients with onychopathies were largely characterized by the spastic-atonic type of the changes in the microcirculatory bed. The changes of this type were documented in 86,5% of the patients with psoriatic onychopathy and in 83,9% of those presenting with onychodystrophy associated with eczema. The effectiveness of the combined treatment including the application of interferential currents was estimated in comparison with that of standard therapy. It was shown that the use of interferential currents for the treatment of the patients with psoriasis results in a decrease of the severity index of nail damage by 47,8% in comparison with 18,1% in the case of standard medicamentous therapy. Similarly, a 77,2 and 51,3% decrease of the index of severity was documented in the patients with eczema after their treatment with the use of interferential currents and standard medicamentous therapy, respectively.

  11. [Current situation in clinical trials with vaccines in the Czech Republic].

    Science.gov (United States)

    Čečetková, B; Smetana, J; Chlíbek, R

    2014-11-01

    Clinical trials are an important part of clinical research. The conduction of clinical trials is strictly regulated and has to comply with an approved protocol. Local regulatory authorities, independent ethic committees, sponsors of clinical trials as well as the investigators are involved from the submission until the very end of the trial. All clinical trials performed in the Czech Republic have to be approved by the State Institute for Drug Control and by the Ethics Committee. The regulatory bodies and independent ethics committees evaluate and continuously supervise the justification and protocol of the clinical trial, quality of the investigational medicinal products and, primarily, the safety of the participants (patients and/or healthy volunteers) in clinical trials. In the Czech Republic there are many advanced clinical research centres, either located in private practices or within hospitals. The investigators are able to conduct a wide variety of clinical trials and recruit a high number of subjects for the trials, as well as to comply with the Good Clinical Practice guidelines and other regulatory requirements. The aim of this article is to summarise the current situation of clinical trials in the Czech Republic as well as the opportunities for getting involved in clinical trials and obligations arising for health professionals from such an involvement.

  12. Sulfur Dioxide (SO2) Primary Standards Documents from Current Review - Federal Register Notices

    Science.gov (United States)

    EPA develops and publishes a notice of proposed rulemaking regarding the review of the SO2 national ambient air quality standards (NAAQS). A public comment period follows. Taking into account comments received on the proposed rule, EPA issues a final rule.

  13. A Historical Perspective and Current Views on the "Standards for Educational and Psychological Testing"

    Science.gov (United States)

    Camara, Wayne J.; Lane, Suzanne

    2006-01-01

    The "Standards for Educational and Psychological Testing" have evolved in the breadth and depth of coverage of issues in educational testing and measurement since their first publication in 1954. There were a number of substantive changes in the 1999 revision that addressed validity, fairness, accommodations, and compliance with the…

  14. School Nursing Documentation: Knowledge, Attitude, and Barriers to Using Standardized Nursing Languages and Current Practices

    Science.gov (United States)

    Yearous, Sharon Kay Guthrie

    2011-01-01

    The independent, complex role of a school nurse requires accurate documentation of assessments, interventions, and outcomes. Consistent documentation by all school nurses is crucial to study the impact of nursing interventions on children's health and success in school. While standardized nursing languages are available, the actual use of…

  15. From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal potencies

    Directory of Open Access Journals (Sweden)

    Wania Papile Galhardi

    2009-12-01

    Full Text Available Background: 20 years ago we began to standardize the procedures of preparation and use of fifty-millesimal dilutions (LM or Q according to indications in the 6th edition of Hahnemann’s Organon. Aim: to describe the main stages in standardization as well as our teaching and research experience on Organon 6th edition. Results: with the use of standardized LM dilutions we observed a lower incidence of homeopathic aggravation than with our earlier experience with non standardized preparations. Organon.modus, a clinical-pharmaceutical protocol derived from the standardization was adequate for the teaching of homeopathy at Faculty of Medicine of Jundiai (São Paulo, the first Brazilian medical school with a graduate course on homeopathy. A randomized double-blind trial comparing individualized homeopathic medicines prescribed in LM dilutions and fluoxetine showed the former not be inferior to the latter in the treatment of moderate-to-severe depression. Conclusion: protocol Organon.modus showed to be adequate to graduate-level teaching of homeopathy and efficient in a controlled clinical trials, favoring its use as common denominator between the art of healing and medical science.

  16. Multiday Transcranial Direct Current Stimulation Causes Clinically Insignificant Changes in Childhood Dystonia: A Pilot Study.

    Science.gov (United States)

    Bhanpuri, Nasir H; Bertucco, Matteo; Young, Scott J; Lee, Annie A; Sanger, Terence D

    2015-10-01

    Abnormal motor cortex activity is common in dystonia. Cathodal transcranial direct current stimulation may alter cortical activity by decreasing excitability while anodal stimulation may increase motor learning. Previous results showed that a single session of cathodal transcranial direct current stimulation can improve symptoms in childhood dystonia. Here we performed a 5-day, sham-controlled, double-blind, crossover study, where we measured tracking and muscle overflow in a myocontrol-based task. We applied cathodal and anodal transcranial direct current stimulation (2 mA, 9 minutes per day). For cathodal transcranial direct current stimulation (7 participants), 3 subjects showed improvements whereas 2 showed worsening in overflow or tracking error. The effect size was small (about 1% of maximum voluntary contraction) and not clinically meaningful. For anodal transcranial direct current stimulation (6 participants), none showed improvement, whereas 5 showed worsening. Thus, multiday cathodal transcranial direct current stimulation reduced symptoms in some children but not to a clinically meaningful extent, whereas anodal transcranial direct current stimulation worsened symptoms. Our results do not support transcranial direct current stimulation as clinically viable for treating childhood dystonia.

  17. Standard requirements for GCP-compliant data management in multinational clinical trials

    LENUS (Irish Health Repository)

    Ohmann, Christian

    2011-03-22

    Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN) has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM) part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections) and 13 other requirements (2 sections). Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials across the unit

  18. Standard requirements for GCP-compliant data management in multinational clinical trials

    Directory of Open Access Journals (Sweden)

    McPherson Gladys

    2011-03-01

    Full Text Available Abstract Background A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre. Unfortunately, no specific, practical and open standard for both GCP-compliant data management and the underlying IT-infrastructure is available to improve the situation. For that reason the "Working Group on Data Centres" of the European Clinical Research Infrastructures Network (ECRIN has developed a standard specifying the requirements for high quality GCP-compliant data management in multinational clinical trials. Methods International, European and national regulations and guidelines relevant to GCP, data security and IT infrastructures, as well as ECRIN documents produced previously, were evaluated to provide a starting point for the development of standard requirements. The requirements were produced by expert consensus of the ECRIN Working group on Data Centres, using a structured and standardised process. The requirements were divided into two main parts: an IT part covering standards for the underlying IT infrastructure and computer systems in general, and a Data Management (DM part covering requirements for data management applications in clinical trials. Results The standard developed includes 115 IT requirements, split into 15 separate sections, 107 DM requirements (in 12 sections and 13 other requirements (2 sections. Sections IT01 to IT05 deal with the basic IT infrastructure while IT06 and IT07 cover validation and local software development. IT08 to IT015 concern the aspects of IT systems that directly support clinical trial management. Sections DM01 to DM03 cover the implementation of a specific clinical data management application, i.e. for a specific trial, whilst DM04 to DM12 address the data management of trials

  19. [The analytical reliability of clinical laboratory information and role of the standards in its support].

    Science.gov (United States)

    Men'shikov, V V

    2012-12-01

    The article deals with the factors impacting the reliability of clinical laboratory information. The differences of qualities of laboratory analysis tools produced by various manufacturers are discussed. These characteristics are the causes of discrepancy of the results of laboratory analyses of the same analite. The role of the reference system in supporting the comparability of laboratory analysis results is demonstrated. The project of national standard is presented to regulate the requirements to standards and calibrators for analysis of qualitative and non-metrical characteristics of components of biomaterials.

  20. [Allergic fungi: importance of the standardization of fungal extracts and their application on clinical practice].

    Science.gov (United States)

    Ruiz Reyes, Héctor; Rodríguez Orozco, Alain R

    2006-01-01

    Among the aeroallergens associated to asthma and allergic rhinitis, the fungi are a common cause of diagnostic and therapeutic problems. The wide variety and distribution of fungal species and the complex characterization of their allergenicity, is a complex item. The fungus extracts used to diagnose and treat sensitizations are frequently non effective, and different varieties of extracts are globally distributed. The standardization of commercial fungi extracts results extremely important as diagnostic procedure as well as to decide an efficacious and safe immunotherapy. This paper reviews important methodological steps to the standardization of fungi extracts, and finally the clinical use of these extracts.

  1. Clinical trial or standard treatment? Shared decision making at the department of oncology

    DEFF Research Database (Denmark)

    Gregersen, Trine Ammentorp; Birkelund, Regner; Ammentorp, Jette

    2016-01-01

    Title: Clinical trial or standard treatment? Shared decision making at the department of oncology. Authors: Ph.d. student, Trine A. Gregersen. Trine.gregersen@rsyd.dk. Department of Oncology. Health Services Research Unit Lillebaelt Hospital / IRS University of Southern Denmark. Professor, Regner...... are involved in difficult treatment decisions including participation in clinical trials. The literature indicates that the decision is very often based on little knowledge about the treatment and that many patients who have consented to participate in a clinical trial are not always aware...... that they are participating in a trial. This place great demand on the healthcare providers’ ability to involve and advise patients in the decisions. The aim of this study is to investigate the characteristics of the communication when decisions about participation in clinical oncology trial are made and the patients...

  2. Investigation and analysis of clinical trial research nurse to perform standard operating procedures

    Institute of Scientific and Technical Information of China (English)

    Yan Lin; Yan-Yun Wu; Mei-Hua Wu; Xiu-Yu Yang; Ming Zhou

    2016-01-01

    Objective: The aim of this study was to investigate the situations and factors that cause nurses not to follow standard operating procedures (SOPs) during the clinical trial process. Methods: Five cases involving patients enrolled in a clinical trial were divided into two groups, pre-SOP training and post-SOP training, to compare and observe the process problems and whether nurses fol-lowed SOPs in clinical trials. The causes of problems were analyzed and corrective measures were proposed. Results: Our results indicate significant improvement in compliance with SOPs after training. There were three occurrences of irregular behavior after training compared with 21 occurrences of irregular behavior before training. Conclusions: The quality of clinical trials can be improved if nurses strictly follow SOPs.

  3. Are Randomized Controlled Trials the (G)old Standard? From Clinical Intelligence to Prescriptive Analytics.

    Science.gov (United States)

    Van Poucke, Sven; Thomeer, Michiel; Heath, John; Vukicevic, Milan

    2016-07-06

    Despite the accelerating pace of scientific discovery, the current clinical research enterprise does not sufficiently address pressing clinical questions. Given the constraints on clinical trials, for a majority of clinical questions, the only relevant data available to aid in decision making are based on observation and experience. Our purpose here is 3-fold. First, we describe the classic context of medical research guided by Poppers' scientific epistemology of "falsificationism." Second, we discuss challenges and shortcomings of randomized controlled trials and present the potential of observational studies based on big data. Third, we cover several obstacles related to the use of observational (retrospective) data in clinical studies. We conclude that randomized controlled trials are not at risk for extinction, but innovations in statistics, machine learning, and big data analytics may generate a completely new ecosystem for exploration and validation.

  4. Smartphone use in dermatology for clinical photography and consultation: Current practice and the law.

    Science.gov (United States)

    Abbott, Lisa M; Magnusson, Roger S; Gibbs, Emma; Smith, Saxon D

    2017-02-28

    Smartphones are rapidly changing the way doctors capture and communicate clinical information, particularly in highly visual specialties such as dermatology. An understanding of how and why smartphones are currently used in clinical practice is critical in order to evaluate professional and legal risks, and to formulate policies that enable safe use of mobile technologies for the maximal benefit of practitioners and patients. Australian dermatologists and dermatology trainees were surveyed on their current practices relating to clinical smartphone use. Of the 105 respondents, 101 provided useable results. The data show clinical smartphone use is common and frequent, with more than 50% of respondents sending and receiving images on their smartphones at least weekly. Clinical photographs were usually sent via multimedia message or email and were commonly stored on smartphones (46%). Security measures adopted to protect data were limited. There was inadequate documentation of consent for transmission of photographs and advice provided. Only 22% of respondents were aware of clear policies in their workplace regarding smartphone use, and a majority desired further education on digital image management. Given the frequency of use and the degree of importance placed on the ability to send and receive clinical images, clinical smartphone use will persist and will likely increase over time. Current practices are insufficient to comply with professional and legal obligations, and increase practitioners' vulnerability to civil and disciplinary proceedings. Further education, realistic policies and adequate software resources are critical to ensure protection of patients, practitioners and the reputation of the dermatological profession. © 2017 The Australasian College of Dermatologists.

  5. The current status of measurement standards for acoustics and vibration at Inmetro

    OpenAIRE

    Ripper, Gustavo Palmeira; Hoffmann, Walter Erico

    2002-01-01

    ABSTRACT: The Division of Acoustics and Vibration (DIAVI) of INMETRO establishes, validates and maintains the Brazilian national measurement standards used for the realization of the units of physical quantities related to the field of acoustics and vibration. The basic vibration quantity realized by DIAVI is translational acceleration, from which the other motion quantities, i.e., velocity and displacement can be derived. Acoustical physical quantities include sound pressure and sound power...

  6. Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

    Science.gov (United States)

    Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

    2016-03-01

    In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

  7. Current considerations related to physiological differences between the sexes and physical employment standards.

    Science.gov (United States)

    Roberts, Delia; Gebhardt, Deborah L; Gaskill, Steven E; Roy, Tanja C; Sharp, Marilyn A

    2016-06-01

    The use of physical employment standards (PES) has helped ensure that workers have the physical attributes necessary to complete their jobs in a safe and efficient manner. However, PES used in the selection processes have not always reflected the critical physical requirements of the job tasks. Women generally have smaller anthropometric stature than men, less muscle mass, and therefore less strength, power, and endurance, particularly in the upper body. Nonetheless, these attributes in themselves are not valid grounds for exclusion from employment in physically demanding occupations. Selection standards based upon size or strength, irrespective of the job requirements, have resulted in the barring of capable women from physically demanding jobs, claims of gender bias, and costly litigations. To ensure all individuals are provided with equal access to employment, accurate characterization of the critical physical requirements of the job is paramount. This paper summarizes the existing research related to disparities between the sexes that contribute to sex differences in job performance in physically demanding occupations including physical and legal factors. Strategies for mitigating these differences in the setting of PES and the meeting of minimum employment standards are discussed. Where available, injury rates for women and men in physically demanding occupations are presented and the etiology considered. Finally, areas for further research are identified.

  8. Labeling programs and efficiency standards to control the energy consumption of household appliances: current situation, main results and recommendations

    Energy Technology Data Exchange (ETDEWEB)

    Menanteau, Ph.

    2000-09-01

    To control the rise in electricity consumption for specific uses, the industrialized countries started by introducing special programs aimed at improving energy efficiency. Among the different instruments available, labeling programs and minimum energy performance standards (MEPS) have proved to be very effective. The first part of this document presents the current situation, the main results and recommendations concerning the labeling programs and efficiency standards to control the energy consumption of household appliances. This analyze is done for each country in details providing the name of the program or measure, the date of implementation, the objective and the main characteristics of the program, the impacts and evaluation. (A.L.B.)

  9. [Standardized management of acupuncture-moxibustion clinic in Singapore General Hospital].

    Science.gov (United States)

    Cui, Shu-Li; Tan, Kian Hian; Ong, Biauw Chi; Lim, Shih hui; Yong, Yang; Seah, Cheng Ngee; Huang, Youyi; Han, Seong Ng

    2014-02-01

    The standardized management of acupuncture-moxibustion in Singapore General Hospital is introduced. With gradual improvement of outpatient infrastructure, re-training of medical staff, strict disinfection of manipulation, periodical inspection of medical instruments, unified management of writing, saving and processing in medical records and public education of TCM knowledge, a standardized management system in accordance with modernized hospital is gradually established. As a result, efficiency and quality of clinical treatment is continuously increasing. From April of 1998 to December of 2012, a total of 74 654 times of treatment were performed, and treatment amount per day is gradually increased. The unusual condition of acupuncture is avoided. Periodical strict inspection of joint committee authenticated by domestic and overseas medical health organization is repeatedly passed and accepted. Additionally, three clinical researches funded by Singapore Health-care Company are still in progress in acupuncture-moxibustion department.

  10. Rapid versus standard intravenous rehydration in paediatric gastroenteritis: pragmatic blinded randomised clinical trial.

    Science.gov (United States)

    Freedman, Stephen B; Parkin, Patricia C; Willan, Andrew R; Schuh, Suzanne

    2011-11-17

    To determine if rapid rather than standard intravenous rehydration results in improved hydration and clinical outcomes when administered to children with gastroenteritis. Single centre, two arm, parallel randomised pragmatic controlled trial. Blocked randomisation stratified by site. Participants, caregivers, outcome assessors, investigators, and statisticians were blinded to the treatment assignment. Paediatric emergency department in a tertiary care centre in Toronto, Canada. 226 children aged 3 months to 11 years; complete follow-up was obtained on 223 (99%). Eligible children were aged over 90 days, had a diagnosis of dehydration secondary to gastroenteritis, had not responded to oral rehydration, and had been prescribed intravenous rehydration. Children were excluded if they weighed less than 5 kg or more than 33 kg, required fluid restriction, had a suspected surgical condition, or had an insurmountable language barrier. Children were also excluded if they had a history of a chronic systemic disease, abdominal surgery, bilious or bloody vomit, hypotension, or hypoglycaemia or hyperglycaemia. Rapid (60 mL/kg) or standard (20 mL/kg) rehydration with 0.9% saline over an hour; subsequent fluids administered according to protocol. clinical rehydration, assessed with a validated scale, two hours after the start of treatment. prolonged treatment, mean clinical dehydration scores over the four hour study period, time to discharge, repeat visits to emergency department, adequate oral intake, and physician's comfort with discharge. Data from all randomised patients were included in an intention to treat analysis. 114 patients were randomised to rapid rehydration and 112 to standard. One child was withdrawn because of severe hyponatraemia at baseline. There was no evidence of a difference between the rapid and standard rehydration groups in the proportions of participants who were rehydrated at two hours (41/114 (36%) v 33/112 (30%); difference 6.5% (95% confidence

  11. The basophil activation test by flow cytometry: recent developments in clinical studies, standardization and emerging perspectives

    OpenAIRE

    Debard Anne-Lise; Boumiza Radhia; Monneret Guillaume

    2005-01-01

    Abstract The diagnosis of immediate allergy is mainly based upon an evocative clinical history, positive skin tests (gold standard) and, if available, detection of specific IgE. In some complicated cases, functional in vitro tests are necessary. The general concept of those tests is to mimic in vitro the contact between allergens and circulating basophils. The first approach to basophil functional responses was the histamine release test but this has remained controversial due to insufficient...

  12. "Collaboration technology": a case study of innovation in order set and clinical care standardization.

    Science.gov (United States)

    Yount, Brian; McNamara, Timothy

    2008-11-06

    Effective standardization of clinical processes, which is a growing priority for healthcare provider organizations and networks, requires effective teamwork among clinicians and staff from multidisciplinary backgrounds--often from geographically dispersed facilities--to reach consensus on care practices. Yet, most healthcare provider organizations have no precedence or tools for managing large-scale, sustained, collaborative activities. This presentation explores the human and social implications of technology. It specifically addresses healthcare collaboration and describes how innovative collaboration management technologies can be used in the healthcare industry to accelerate care standardization, order set standardization and other initiatives necessary for successful computerized provider order entry and electronic health record deployments. These topics are explored through presentation of a survey of healthcare executives and a case study of an advanced collaboration application that was adapted and deployed in a partnership between a large healthcare provider organization and a commercial developer of document management and collaboration management technologies.

  13. Standardization of Data for Clinical Use and Research in Spinal Cord Injury

    DEFF Research Database (Denmark)

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-01-01

    for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged...... to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures...... to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements...

  14. Remotely-Supervised Transcranial Direct Current Stimulation (tDCS for Clinical Trials: Guidelines for Technology and Protocols

    Directory of Open Access Journals (Sweden)

    Leigh E Charvet

    2015-03-01

    Full Text Available The effect of transcranial direct current stimulation (tDCS is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: 1 training of staff in tDCS treatment and supervision, 2 assessment of the user’s capability to participate in tDCS remotely, 3 ongoing training procedures and materials including assessments of the user and/or caregiver, 4 simple and fail-safe electrode preparation techniques and tDCS headgear, 5 strict dose control for each session, 6 ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol, with corresponding corrective steps as required, 7 monitoring for treatment-emergent adverse effects, 8 guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population’s level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

  15. Current practices and guidelines for clinical next-generation sequencing oncology testing

    Institute of Scientific and Technical Information of China (English)

    Samuel P. Strom

    2016-01-01

    Next-generation sequencing (NGS) has been rapidly integrated into molecular pathology, dramatically increasing the breadth genomic of information available to oncologists and their patients. This review will explore the ways in which this new technology is currently applied to bolster care for patients with solid tumors and hematological malignancies, focusing on practices and guidelines for assessing the technical validity and clinical utility of DNA variants identified during clinical NGS oncology testing.

  16. Computed tomography colonography for the practicing radiologist:A review of current recommendations on methodology and clinical indications

    Institute of Scientific and Technical Information of China (English)

    Paola Scalise; Annalisa Mantarro; Francesca Pancrazi; Emanuele Neri

    2016-01-01

    Colorectal cancer(CRC) represents one of the most relevant causes of morbidity and mortality in Western societies. CRC screening is actually based on faecal occult blood testing, and optical colonoscopy still remains the gold standard screening test for cancer detection. However, computed tomography colonography(CT colonography) constitutes a reliable, minimally-invasive method to rapidly and effectively evaluate the entire colon for clinically relevant lesions. Furthermore, even if the benefits of its employment in CRC mass screening have not fully established yet, CT colonography may represent a reasonable alternative screening test in patients who cannot undergo or refuse colonoscopy. Therefore, the purpose of our review is to illustrate the most updated recommendations on methodology and the current clinical indications of CT colonography, according to the data of the existing relevant literature.

  17. Diagnostic accuracy of the vegetative and minimally conscious state: Clinical consensus versus standardized neurobehavioral assessment

    Directory of Open Access Journals (Sweden)

    Majerus Steve

    2009-07-01

    Full Text Available Abstract Background Previously published studies have reported that up to 43% of patients with disorders of consciousness are erroneously assigned a diagnosis of vegetative state (VS. However, no recent studies have investigated the accuracy of this grave clinical diagnosis. In this study, we compared consensus-based diagnoses of VS and MCS to those based on a well-established standardized neurobehavioral rating scale, the JFK Coma Recovery Scale-Revised (CRS-R. Methods We prospectively followed 103 patients (55 ± 19 years with mixed etiologies and compared the clinical consensus diagnosis provided by the physician on the basis of the medical staff's daily observations to diagnoses derived from CRS-R assessments performed by research staff. All patients were assigned a diagnosis of 'VS', 'MCS' or 'uncertain diagnosis.' Results Of the 44 patients diagnosed with VS based on the clinical consensus of the medical team, 18 (41% were found to be in MCS following standardized assessment with the CRS-R. In the 41 patients with a consensus diagnosis of MCS, 4 (10% had emerged from MCS, according to the CRS-R. We also found that the majority of patients assigned an uncertain diagnosis by clinical consensus (89% were in MCS based on CRS-R findings. Conclusion Despite the importance of diagnostic accuracy, the rate of misdiagnosis of VS has not substantially changed in the past 15 years. Standardized neurobehavioral assessment is a more sensitive means of establishing differential diagnosis in patients with disorders of consciousness when compared to diagnoses determined by clinical consensus.

  18. The current status and trend of clinical pharmacology in developing countries

    Science.gov (United States)

    2013-01-01

    Background Several international forums for promoting clinical pharmacology in developing countries have been held since 1980, and several clinical pharmacology programmes targeting developing countries were instituted such that the status of clinical pharmacology in developing countries is not where it was 50 years ago. Therefore, a survey and an appraisal of the literature on the current status of clinical pharmacology in developing countries were undertaken with a hope that it would enable development of appropriate strategies for further promotion of clinical pharmacology in these countries. Methods First, nine determinants (or enabling factors) for running a successful clinical pharmacology programme were identified, i.e., disease burden, drug situation, economic growth, clinical pharmacology activities, recognition, human capital, government support, international collaboration, and support for traditional/alternative medicines. These factors were then evaluated with regard to their current status in the developing countries that responded to an electronic questionnaire, and their historical perspective, using the literature appraisal. From these, a projected trend was constructed with recommendations on the way forward. Results Clinical pharmacology services, research and teaching in developing countries have improved over the past 50 years with over 90% of countries having the appropriate policies for regulation and rational use of medicines in place. Unfortunately, policy implementation remains a challenge, owing to a worsening disease burden and drug situation, versus fewer clinical pharmacologists and other competing priorities for the national budgets. This has led to a preference for training ‘a physician clinical pharmacologist’ in programmes emphasizing local relevancy and for a shorter time, and the training of other professionals in therapeutics for endemic diseases (task shifting), as the most promising strategies of ensuring rational use of

  19. Modern dental imaging: a review of the current technology and clinical applications in dental practice

    Energy Technology Data Exchange (ETDEWEB)

    Vandenberghe, Bart; Jacobs, Reinhilde [Katholieke Universiteit Leuven, Oral Imaging Centre, Faculty of Medicine, School of Dentistry, Oral Pathology and Maxillofacial Surgery, Leuven (Belgium); Bosmans, Hilde [Katholieke Universiteit Leuven, Radiology Section, Department of Medical Diagnostic Sciences, Leuven (Belgium)

    2010-11-15

    A review of modern imaging techniques commonly used in dental practice and their clinical applications is presented. The current dental examinations consist of intraoral imaging with digital indirect and direct receptors, while extraoral imaging is divided into traditional tomographic/panoramic imaging and the more recently introduced cone beam computed tomography. Applications, limitations and current trends of these dental ''in-office'' radiographic techniques are discussed. (orig.)

  20. Single-Case Experimental Designs: A Systematic Review of Published Research and Current Standards

    Science.gov (United States)

    Smith, Justin D.

    2013-01-01

    This article systematically reviews the research design and methodological characteristics of single-case experimental design (SCED) research published in peer-reviewed journals between 2000 and 2010. SCEDs provide researchers with a flexible and viable alternative to group designs with large sample sizes. However, methodological challenges have precluded widespread implementation and acceptance of the SCED as a viable complementary methodology to the predominant group design. This article includes a description of the research design, measurement, and analysis domains distinctive to the SCED; a discussion of the results within the framework of contemporary standards and guidelines in the field; and a presentation of updated benchmarks for key characteristics (e.g., baseline sampling, method of analysis), and overall, it provides researchers and reviewers with a resource for conducting and evaluating SCED research. The results of the systematic review of 409 studies suggest that recently published SCED research is largely in accordance with contemporary criteria for experimental quality. Analytic method emerged as an area of discord. Comparison of the findings of this review with historical estimates of the use of statistical analysis indicates an upward trend, but visual analysis remains the most common analytic method and also garners the most support amongst those entities providing SCED standards. Although consensus exists along key dimensions of single-case research design and researchers appear to be practicing within these parameters, there remains a need for further evaluation of assessment and sampling techniques and data analytic methods. PMID:22845874

  1. Qualitative evaluation of a standardized patient clinical simulation for nurse practitioner and pharmacy students.

    Science.gov (United States)

    Koo, Laura; Layson-Wolf, Cherokee; Brandt, Nicole; Hammersla, Margaret; Idzik, Shannon; Rocafort, P Tim; Tran, Deanna; Wilkerson, R Gentry; Windemuth, Brenda

    2014-11-01

    This article describes a qualitative evaluation of an interprofessional educational experience for nurse practitioner and pharmacy students using standardized patients and physicians role-playing physicians in clinical scenarios. This experience included the development of two clinical scenarios; training of standardized patients, providers, and faculty facilitators; pre-briefing preparation; partial facilitator prompting simulations; and facilitated debriefings. Forty-six students participated in the formative simulation. Small groups of students and faculty facilitators worked through two clinical scenarios that were based on the expected emergence of the patient-centered medical homes. The scenarios incorporated different interprofessional communication modes, including in-person, telephonic, and video-conferencing. Time-in/time-out debriefings were incorporated to provide guidance to students about how to engage in interprofessional collaboration. After completion of the scenarios, facilitated group debriefings allowed for reflection on communication strategies and roles. Immediately following the learning activity, 30 volunteer focus group participants provided comments anonymously in a semi-structured format. Conventional content analysis was used to identify overarching themes. Participants expressed improved understanding of individual roles, increased confidence, and a better sense of interprofessional support. The educational experience themes included the benefits of a realistic nature of the simulation and the need for improved student orientation to roles and expectations prior to the clinical simulations. Copyright © 2014 Elsevier Ltd. All rights reserved.

  2. Changes across Three Editions of "The Suicidal Patient: Clinical and Legal Standards of Care": Relevance to Counseling Centers

    Science.gov (United States)

    Polychronis, Paul D.

    2017-01-01

    Treating suicidality is one of the most challenging situations managed by college and university counseling centers. The first edition of Bongar's (1991) "The Suicidal Patient: Clinical and Legal Standards of Care," a compendium of empirical knowledge and clinical research regarding standard of care in the treatment of suicidality, was…

  3. Standardization of chemical analytical techniques for pyrolysis bio-oil: history, challenges, and current status of methods: Bio-oil Analytical Standardization

    Energy Technology Data Exchange (ETDEWEB)

    Ferrell, Jack R. [National Renewable Energy Laboratory (NREL), Golden CO USA; Olarte, Mariefel V. [Pacific Northwest National Laboratory (PNNL), Richland WA USA; Christensen, Earl D. [National Renewable Energy Laboratory (NREL), Golden CO USA; Padmaperuma, Asanga B. [Pacific Northwest National Laboratory (PNNL), Richland WA USA; Connatser, Raynella M. [Oak Ridge National Laboratory (ORNL), Oak Ridge TN USA; Stankovikj, Filip [Washington State University (WSU), Pullman WA USA; Meier, Dietrich [Thünen Institute of Wood Research (TI), Hamburg Germany; Paasikallio, Ville [VTT Technical Research Centre of Finland Ltd (VTT), Espoo Finland

    2016-07-05

    In this perspective, we discuss the standardization of analytical techniques for pyrolysis bio-oils, including the current status of methods, and our opinions on future directions. First, the history of past standardization efforts is summarized, and both successful and unsuccessful validation of analytical techniques highlighted. The majority of analytical standardization studies to-date has tested only physical characterization techniques. Here, we present results from an international round robin on the validation of chemical characterization techniques for bio-oils. Techniques tested included acid number, carbonyl titrations using two different methods (one at room temperature and one at 80 degrees C), 31P NMR for determination of hydroxyl groups, and a quantitative gas chromatography-mass spectrometry (GC-MS) method. Both carbonyl titration and acid number methods have yielded acceptable inter-laboratory variabilities. 31P NMR produced acceptable results for aliphatic and phenolic hydroxyl groups, but not for carboxylic hydroxyl groups. As shown in previous round robins, GC-MS results were more variable. Reliable chemical characterization of bio-oils will enable upgrading research and allow for detailed comparisons of bio-oils produced at different facilities. Reliable analytics are also needed to enable an emerging bioenergy industry, as processing facilities often have different analytical needs and capabilities than research facilities. We feel that correlations in reliable characterizations of bio-oils will help strike a balance between research and industry, and will ultimately help to determine metrics for bio-oil quality. Finally, the standardization of additional analytical methods is needed, particularly for upgraded bio-oils.

  4. Prostate Cancer Immunotherapy with Sipuleucel-T: Current Standards and Future Directions.

    Science.gov (United States)

    Wei, Xiao X; Fong, Lawrence; Small, Eric J

    2015-01-01

    The management of advanced prostate cancer, specifically metastatic castrate-resistant prostate cancer (mCRPC), remains a therapeutic challenge. Sipuleucel-T (Provenge; APC8015) was approved by the FDA in 2010 for the treatment of asymptomatic or minimally symptomatic mCRPC patients, and it remains the only FDA-approved immunotherapy for prostate cancer of any indication to date. Given the continued need to improve therapeutics in patients with advanced prostate cancer, as well as recent enthusiasm for cancer immunotherapy, there is a wide range of ongoing trials evaluating combinations of sipuleucel-T with other therapeutics. Additional trials are aiming to expand the application of sipuleucel-T to prostate cancer patients beyond the mCRPC setting. Ongoing challenges include understanding the full mechanism of action of sipuleucel-T, optimizing the sequence of sipuleucel-T in relation to other therapies for mCRPC in clinical practice, and the identification of surrogate markers to predict survival benefit in clinical trials.

  5. PBOSPECTS FOR CLINICAL APPLICATION OF THE CURRENT ANTI-INFLAMMATORY DRUG MELOXICAM (AMELOTEX

    Directory of Open Access Journals (Sweden)

    M S Eliseev

    2008-01-01

    Full Text Available The paper presents data on the effectiveness, safety, tolerance, major mechanisms of action, and prospects for clinically using meloxicam, a current selective nonsteroidal anti-inflammatory drug, against cyclooxygenase-2. It describes the advantages of meloxicam for injections, which begins acting promptly and shows an adequate long analgesic effect.

  6. Integration of Palliative Care Into Standard Oncology Care: American Society of Clinical Oncology Clinical Practice Guideline Update.

    Science.gov (United States)

    Ferrell, Betty R; Temel, Jennifer S; Temin, Sarah; Alesi, Erin R; Balboni, Tracy A; Basch, Ethan M; Firn, Janice I; Paice, Judith A; Peppercorn, Jeffrey M; Phillips, Tanyanika; Stovall, Ellen L; Zimmermann, Camilla; Smith, Thomas J

    2017-01-01

    Purpose To provide evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists to update the 2012 American Society of Clinical Oncology (ASCO) provisional clinical opinion (PCO) on the integration of palliative care into standard oncology care for all patients diagnosed with cancer. Methods ASCO convened an Expert Panel of members of the ASCO Ad Hoc Palliative Care Expert Panel to develop an update. The 2012 PCO was based on a review of a randomized controlled trial (RCT) by the National Cancer Institute Physicians Data Query and additional trials. The panel conducted an updated systematic review seeking randomized clinical trials, systematic reviews, and meta-analyses, as well as secondary analyses of RCTs in the 2012 PCO, published from March 2010 to January 2016. Results The guideline update reflects changes in evidence since the previous guideline. Nine RCTs, one quasiexperimental trial, and five secondary analyses from RCTs in the 2012 PCO on providing palliative care services to patients with cancer and/or their caregivers, including family caregivers, were found to inform the update. Recommendations Inpatients and outpatients with advanced cancer should receive dedicated palliative care services, early in the disease course, concurrent with active treatment. Referral of patients to interdisciplinary palliative care teams is optimal, and services may complement existing programs. Providers may refer family and friend caregivers of patients with early or advanced cancer to palliative care services.

  7. Current Situation and Development Trend of Standards of Lithium Batteries for Electric Vehides

    Institute of Scientific and Technical Information of China (English)

    Meng Xiangfeng; Wen Baozhong

    2012-01-01

    Traction battery is one of the most significant systems in electric vehicles.Its general performance,cycle characteristics and safety performance have crucial influence on the economical efficiency,dynamic property and safety of the vehicle.Therefore traction battery has always been the key area in researches of electric vehicles and its standardization. 1.Main performance indicators of traction batteries As the energy storage device of electric vehicles,the performance of traction battery is very important for the complete vehicle.Requirements of traction battery for electric vehicles should have the following characteristics as high power,high energy,high energy density/specific energy,high power density/specific power,low cost,long life length,abuse resistance,high reliability,good temperature property,short charging time,nice interchangeability etc.Traction batteries used at present are mainly lead-acid cells,nickel-hydride cells and lithium-ion cells.Although none of them can meet all requirements,lithium battery is widely regarded the most promising one with optimal comprehensive performance in recent time.

  8. Detection of High Frequency Oscillations by Hybrid Depth Electrodes in Standard Clinical Intracranial EEG Recordings

    Directory of Open Access Journals (Sweden)

    Efstathios D Kondylis

    2014-08-01

    Full Text Available High frequency oscillations (HFOs have been proposed as a novel marker for epileptogenic tissue, spurring tremendous research interest into the characterization of these transient events. A wealth of continuously recorded intracranial electroencephalographic (iEEG data is currently available from patients undergoing invasive monitoring for the surgical treatment of epilepsy. In contrast to data recorded on research-customized recording systems, data from clinical acquisition systems remain an underutilized resource for HFO detection in most centers. The effective and reliable use of this clinically obtained data would be an important advance in the ongoing study of HFOs and their relationship to ictogenesis. The diagnostic utility of HFOs ultimately will be limited by the ability of clinicians to detect these brief, sporadic, and low amplitude events in an electrically noisy clinical environment. Indeed, one of the most significant factors limiting the use of such clinical recordings for research purposes is their low signal to noise ratio, especially in the higher frequency bands. In order to investigate the presence of HFOs in clinical data, we first obtained continuous intracranial recordings in a typical clinical environment using a commercially available, commonly utilized data acquisition system and off the shelf hybrid macro/micro depth electrodes. This data was then inspected for the presence of HFOs using semi-automated methods and expert manual review. With targeted removal of noise frequency content, HFOs were detected on both macro- and micro-contacts, and preferentially localized to seizure onset zones. HFOs detected by the offline, semi-automated method were also validated in the clinical viewer, demonstrating that 1 this clinical system allows for the visualization of HFOs, and 2 with effective signal processing, clinical recordings can yield valuable information for offline analysis.

  9. A proposed protocol for the standardized preparation of PRF membranes for clinical use.

    Science.gov (United States)

    Kobayashi, Mito; Kawase, Tomoyuki; Horimizu, Makoto; Okuda, Kazuhiro; Wolff, Larry F; Yoshie, Hiromasa

    2012-09-01

    Upon clinical application, thick platelet-rich fibrin (PRF) is usually compressed to fit the implantation site. However, it is speculated that the preservation of platelets and plasma content depends on the compression methods used. To accurately evaluate the clinical outcome of PRF, the preparation protocol should be standardized. Freshly prepared PRF clots were compressed into a thin membrane by our novel PRF compression device. The localization of platelets was examined by SEM and immunostaining. Growth factor levels were evaluated by bioassays and cytokine-antibody array techniques. The angiogenic activity was examined by the chick chorioallantoic membrane assay and the scratch assay using HUVEC cultures. Platelets were concentrated on the surface of the region adjacent to the red thrombus and this region was subjected to the experiments. Compared to the PRF membrane compressed by dry gauze (G-PRF), the preservation of the plasma content, 3D-fibrin meshwork, and platelets was more intact in the compressor-prepared PRF membrane (C-PRF). Among the growth factors tested, C-PRF contained PDGF isoforms at higher levels, and significantly stimulated cell proliferation and neovascularization. C-PRF may be useful for grafting while minimizing the loss of bioactive factors. This C-PRF preparation protocol is proposed as a standardized protocol for PRF membrane preparation. Copyright © 2012 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

  10. Whole-body magnetic resonance angiography of patients using a standard clinical scanner

    Energy Technology Data Exchange (ETDEWEB)

    Hansen, Tomas; Wikstroem, Johan; Eriksson, Mats-Ola; Lundberg, Anders; Ahlstroem, Haakan [Uppsala University Hospital, Department of Diagnostic Radiology, Uppsala (Sweden); Johansson, Lars [Uppsala University Hospital, Uppsala (Sweden); Ljungman, Christer [Uppsala University Hospital, Department of Vascular Surgery, Uppsala (Sweden); Hoogeven, Romhild [Philips Medical Systems, MR Clinical Science, Best (Netherlands)

    2006-01-01

    The purpose of this study was to evaluate the technique of whole-body magnetic resonance angiography (MRA) of patients with a standard clinical scanner. Thirty-three patients referred for stenoses, occlusions, aneurysms, assessment of patency of vascular grafts, vasculitis and vascular aplasia were examined in a 1.5-T scanner using its standard body coil. Three-dimensional sequences were acquired in four stations after administration of one intravenous injection of 40 ml conventional gadolinium contrast agent. Different vessel segments were evaluated as either diagnostic or nondiagnostic and regarding the presence of stenoses with more than 50% diameter reduction, occlusions or aneurysms. Of 923 vessel segments, 67 were not evaluable because of poor contrast filling (n=31), motion artefacts (n=20), venous overlap (n=12) and other reasons (n=4). Stenoses of more than 50%, occlusions or aneurysms were observed in 26 patients (129 segments). In nine patients additional unsuspected pathology was found. In 10 out of 14 patients (71/79 segments) there was conformity between MRA and digital subtraction angiography regarding the grade of stenosis. This study shows that whole-body MRA with a standard clinical scanner is feasible. Motion artefacts and the timing of the contrast agent through the different segments are still problems to be solved. (orig.)

  11. The basophil activation test by flow cytometry: recent developments in clinical studies, standardization and emerging perspectives

    Directory of Open Access Journals (Sweden)

    Debard Anne-Lise

    2005-06-01

    Full Text Available Abstract The diagnosis of immediate allergy is mainly based upon an evocative clinical history, positive skin tests (gold standard and, if available, detection of specific IgE. In some complicated cases, functional in vitro tests are necessary. The general concept of those tests is to mimic in vitro the contact between allergens and circulating basophils. The first approach to basophil functional responses was the histamine release test but this has remained controversial due to insufficient sensitivity and specificity. During recent years an increasing number of studies have demonstrated that flow cytometry is a reliable tool for monitoring basophil activation upon allergen challenge by detecting surface expression of degranulation/activation markers (CD63 or CD203c. This article reviews the recent improvements to the basophil activation test made possible by flow cytometry, focusing on the use of anti-CRTH2/DP2 antibodies for basophil recognition. On the basis of a new triple staining protocol, the basophil activation test has become a standardized tool for in vitro diagnosis of immediate allergy. It is also suitable for pharmacological studies on non-purified human basophils. Multicenter studies are now required for its clinical assessment in large patient populations and to define the cut-off values for clinical decision-making.

  12. The basophil activation test by flow cytometry: recent developments in clinical studies, standardization and emerging perspectives.

    Science.gov (United States)

    Boumiza, Radhia; Debard, Anne-Lise; Monneret, Guillaume

    2005-06-30

    The diagnosis of immediate allergy is mainly based upon an evocative clinical history, positive skin tests (gold standard) and, if available, detection of specific IgE. In some complicated cases, functional in vitro tests are necessary. The general concept of those tests is to mimic in vitro the contact between allergens and circulating basophils. The first approach to basophil functional responses was the histamine release test but this has remained controversial due to insufficient sensitivity and specificity. During recent years an increasing number of studies have demonstrated that flow cytometry is a reliable tool for monitoring basophil activation upon allergen challenge by detecting surface expression of degranulation/activation markers (CD63 or CD203c). This article reviews the recent improvements to the basophil activation test made possible by flow cytometry, focusing on the use of anti-CRTH2/DP2 antibodies for basophil recognition. On the basis of a new triple staining protocol, the basophil activation test has become a standardized tool for in vitro diagnosis of immediate allergy. It is also suitable for pharmacological studies on non-purified human basophils. Multicenter studies are now required for its clinical assessment in large patient populations and to define the cut-off values for clinical decision-making.

  13. QUEST-RA: quantitative clinical assessment of patients with rheumatoid arthritis seen in standard rheumatology care in 15 countries

    DEFF Research Database (Denmark)

    Sokka, Tuulikki; Kautiainen, Hannu; Toloza, Sergio

    2007-01-01

    ) within and between countries was graphically analysed. A median regression model was applied to analyse differences in disease activity between countries. RESULTS: Between January 2005 and October 2006, the QUEST-RA (Quantitative Patient Questionnaires in Standard Monitoring of Patients with Rheumatoid...... of clinical status and treatments of patients with RA in standard clinical care in 2005-6 including countries that are infrequently involved in clinical research projects....

  14. Standardization of Data for Clinical Use and Research in Spinal Cord Injury.

    Science.gov (United States)

    Biering-Sørensen, Fin; Noonan, Vanessa K

    2016-08-12

    Increased survival after spinal cord injury (SCI) worldwide has enhanced the need for quality data that can be compared and shared between centers, countries, as well as across research studies, to better understand how best to prevent and treat SCI. Such data should be standardized and be able to be uniformly collected at any SCI center or within any SCI study. Standardization will make it possible to collect information from larger SCI populations for multi-center research studies. With this aim, the international SCI community has obtained consensus regarding the best available data and measures for use in SCI clinical practice and research. Reporting of SCI data is likewise standardized. Data elements are continuously updated and developed using an open and transparent process. There are ongoing internal, as well as external review processes, where all interested parties are encouraged to participate. The purpose of this review paper is to provide an overview of the initiatives to standardize data including the International Spinal Cord Society's International SCI Data Sets and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Common Data Elements Project within SCI and discuss future opportunities.

  15. Comparative evaluation of an ambulatory EEG platform vs. clinical gold standard.

    Science.gov (United States)

    Jackson, Gregory; Radhu, Natasha; Sun, Yinming; Tallevi, Kevin; Ritvo, Paul; Daskalakis, Zafiris J; Grundlehner, Bernard; Penders, Julien; Cafazzo, Joseph A

    2013-01-01

    Electroencephalography (EEG) testing in clinical labs makes use of large amplifiers and complex software for data acquisition. While there are new ambulatory electroencephalogram (EEG) systems, few have been directly compared to a gold standard system. Here, an ultra-low power wireless EEG system designed by Imec is tested against the gold standard Neuroscan SynAmps2 EEG system, recording simultaneously from the same laboratory cap prepared with electrode gel. The data was analyzed using correlation analysis for both time domain and frequency domain data. The analysis indicated a high Pearson's correlation coefficient (mean=0.957, median=0.985) with high confidence (mean P=0.002) for 10-second sets of data transformed to the frequency domain. The time domain results had acceptable Pearson's coefficient (mean=0.580, median =0.706) with high confidence (mean P=0.008).

  16. Biochemical and immunological analysis of mould skin prick test solution: current status of standardization.

    Science.gov (United States)

    Kespohl, S; Maryska, S; Zahradnik, E; Sander, I; Brüning, T; Raulf-Heimsoth, M

    2013-11-01

    Sensitization prevalence to moulds reached from less than 10% in the general population to more than 25% in atopic and/or asthmatic subjects. To diagnose IgE-mediated mould sensitization, skin prick test (SPT) and specific IgE (sIgE) measurement are recommended. However, concordance of SPT and sIgE results is often less than 50% and standardization of the extracts is required to achieve reliable test results. The aim of our study was to analyse mould SPT solutions (SPTs) with respect to quantity and quality of protein, antigen and human IgE-binding content as a prerequisite for further in vivo studies. Commercial SPTs of Alternaria alternata, Aspergillus fumigatus, Cladosporium herbarum and Penicillium chrysogenum from six manufacturers as well as two in-house extracts from Aspergillus versicolor were investigated. Protein-, antigen- and IgE-binding contents were quantified by Bradford assay, sandwich ELISA and IgE-ImmunoCAP-inhibition tests. Protein composition and IgE and IgG binding were analysed by SDS-PAGE and immunoblotting, respectively. Median protein concentrations were similar in all mould SPT extracts (90-110 μg/mL). In contrast, antigen contents and IgE-binding capacity showed a high variability with median antigen values from 4 to 118 μg/mL and IgE inhibition results between 30 to 95%. Whereas almost all SPTs of A. alternata and A. versicolor showed complete sIgE inhibition with mean values > 80%, only three extracts for A. fumigatus, two extracts for C. herbarum and none of the tested extracts for P. chrysogenum exceeded 50% sIgE reduction. Quantitative amounts of protein, antigenic and IgE-binding structures were not comparable with the quality of the corresponding protein or immunoblot pattern, with the exception of A. alternata SPTs. Commercially available mould SPT extracts showed high variability raising the question of comparability and reliability of SPT results. Possible consequences for diagnostic test outcome will be investigated

  17. [Discussion on strengthening yin of chinese herbs with bitter-flavor clinical traditional Chinese pharmacology noun terminology standardization research].

    Science.gov (United States)

    Liu, Xiao-Mei; Bao; Zhaorigetu; Zhuang, Xin-Ying; Que, Ling; Tian, Chang-Jiang

    2013-10-01

    Clinical traditional Chinese pharmacology is the subject that study of basic theory of traditional Chinese medicine, property of Chinese materia medica and clinical application. The study on the standardization research of the terminology of clinical traditional Chinese pharmacology is an important premise and foundation to standardization, modernization and internationalization, informationization construction of clinical traditional Chinese pharmacology and is also the important content of the subject construction. To provide some exploring ideas for clinical traditional Chinese pharmacology noun terminology standardization, this article elaborates the concept of strengthening Yin with bitter-flavor herbs in several aspects, such as connotation and the historical origin, the clinical application in the traditional, modern clinic application, and the modern basic research and so on.

  18. Ethical standards for clinical trials conducted in third countries: the new strategy of the European Medicines Agency.

    Science.gov (United States)

    Altavilla, Annagrazia

    2011-01-01

    Clinical trials increasingly occur on a global scale as industry and government sponsors in wealthy countries move trials to low- and middle-income countries. The globalization of clinical research raises important questions about the economical and ethical aspects of clinical research and the translation of trial results to clinical practice: which ethical standards are applied? Are trials results accurate and valid, and can they be extrapolated to other settings? This article provides an overview of the strategy approved by the European Medicines Agency (EMA) to clarify ethical standards for clinical research conducted outside the European Economic Area (EEA) and included in Marketing Authorization Applications. Reference to the EMA Reflection paper is made.

  19. The effect of examinee and patient ethnicity in clinical-skills assessment with standardized patients.

    Science.gov (United States)

    Colliver, J A; Swartz, M H; Robbs, R S

    2001-01-01

    Ethnicity has been a continuing concern for the valid assessment of clinical performance with standardized patients (SPs). The concern is that examinee ethnicity and SP ethnicity might interact, such that examinees might score higher in encounters with SPs of the same ethnicity. To test for an interaction of examinee ethnicity and SP ethnicity on clinical performance in an SP examination. History-taking and physical-examination scores and interpersonal-and communication-skills scores, both based on checklists completed by SPs. Poststation scores for answers to case-related questions concerning pathophysiology, diagnosis, test selection, and test interpretation. Two graduating classes of over 1,000 fourth-year medical students each in the New York City Consortium were tested on the SP assessment administered at The Morchand Center of Mount Sinai School of Medicine. The primary analyses were two-way (2 x 2) analyses, to test the main and interaction effects of examinee ethnicity and SP ethnicity. Effect-size measures (standardized mean differences, d) were computed to provide a sharper picture of the effects. Of the 24 interaction analyses, only three were statistically significant (not significantly more than expected by chance) and the results were mixed: one analysis showed better examinee performance in encounters with SPs of the same ethnic background and the other two showed the opposite. For all 24 interactions, significant or not, the results showed weak effects and no consistent pattern. White examinees scored on average 0.12 standard deviations above black examinees in encounters with white SPs, and 0.11 standard deviations higher in encounters with black SPs. These initial results are encouraging and should dispel some of the concern about ethnicity in SP assessment, at least about the operation of an examinee-by-SP-ethnicity interaction that would pose a serious threat to the validity of the examination scores.

  20. Treatment effect heterogeneity for univariate subgroups in clinical trials: Shrinkage, standardization, or else.

    Science.gov (United States)

    Varadhan, Ravi; Wang, Sue-Jane

    2016-01-01

    Treatment effect heterogeneity is a well-recognized phenomenon in randomized controlled clinical trials. In this paper, we discuss subgroup analyses with prespecified subgroups of clinical or biological importance. We explore various alternatives to the naive (the traditional univariate) subgroup analyses to address the issues of multiplicity and confounding. Specifically, we consider a model-based Bayesian shrinkage (Bayes-DS) and a nonparametric, empirical Bayes shrinkage approach (Emp-Bayes) to temper the optimism of traditional univariate subgroup analyses; a standardization approach (standardization) that accounts for correlation between baseline covariates; and a model-based maximum likelihood estimation (MLE) approach. The Bayes-DS and Emp-Bayes methods model the variation in subgroup-specific treatment effect rather than testing the null hypothesis of no difference between subgroups. The standardization approach addresses the issue of confounding in subgroup analyses. The MLE approach is considered only for comparison in simulation studies as the "truth" since the data were generated from the same model. Using the characteristics of a hypothetical large outcome trial, we perform simulation studies and articulate the utilities and potential limitations of these estimators. Simulation results indicate that Bayes-DS and Emp-Bayes can protect against optimism present in the naïve approach. Due to its simplicity, the naïve approach should be the reference for reporting univariate subgroup-specific treatment effect estimates from exploratory subgroup analyses. Standardization, although it tends to have a larger variance, is suggested when it is important to address the confounding of univariate subgroup effects due to correlation between baseline covariates. The Bayes-DS approach is available as an R package (DSBayes).

  1. Incidence of unanticipated difficult airway using an objective airway score versus a standard clinical airway assessment

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet; Rosenstock, Charlotte Valentin; Wetterslev, Jørn

    2013-01-01

    the examination and registration of predictors for difficult mask ventilation with a non-specified clinical airway assessment on prediction of difficult mask ventilation.Method/Design: We cluster-randomized 28 Danish departments of anaesthesia to airway assessment either by the SARI or by usual non...... reduction equalling a number needed to treat of 180. Sample size estimation is adjusted for the study design and based on standards for randomization on cluster-level. With an average cluster size of 2,500 patients, 70,000 patients will be enrolled over a 1-year trial period. The database is programmed so...

  2. Comparison of current perception threshold electrical testing to clinical sensory testing for lingual nerve injuries.

    Science.gov (United States)

    Ziccardi, Vincent B; Dragoo, Joel; Eliav, Eli; Benoliel, Rafael

    2012-02-01

    We performed a retrospective study of lingual nerve injury assessment comparing the techniques of current perception threshold testing versus clinical sensory testing. We designed and implemented a cross-sectional study and enrolled a patient sample with lingual nerve injuries presenting for treatment to the principal investigator. The predictor variables were clinical sensory testing modalities (ie, temperature, nocioception, vibration, 2-point discrimination, brush stroke, and von Frey monofilament perception). The primary outcome variable was the electrical current perception thresholds of the tongue dorsum (neurometer measurements at 5, 250, and 2,000 Hz). Comparisons were established with the ipsilateral affected and contralateral unaffected lingual nerve distributions. The associations between the clinical sensory testing and current perception threshold measurements were assessed using correlation coefficients, with the level of statistical significance set at P thresholds at 2,000 Hz and the 2-point discrimination, reaction to brushing, reaction to vibration, and von Frey fiber thresholds, between the electrical stimulation thresholds at 250 Hz to the nociceptive and thermal thresholds, and between the electrical stimulation thresholds at 5 Hz to thermal stimuli. The significant correlations observed in the present study indicate that current perception threshold can be a complementary or alternative tool in the assessment and evaluation of lingual nerve injuries. Copyright © 2012 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  3. Connecting public health and clinical information systems by using a standardized methodology.

    Science.gov (United States)

    Lopez, Diego M; Blobel, Bernd G M E

    2007-01-01

    To meet the challenge for efficient, high quality and sustainable care, health systems in developed and increasingly in developing countries require extended communication and cooperation between all principals involved in citizen's care. The challenge also concerns supporting information systems, which demand interoperation with public health, bioinformatics, genomics, administrative, governmental, and other sources of data. The paper describes an architecture development methodology for modeling the integration between clinical and public health information systems that harmonizes existent standardized modeling approaches and integrates HL7 domain knowledge. An integration-architecture for information sharing between public health surveillance and clinical information systems is derived demonstrating the feasibility of the proposed methodology. Predominantly, a harmonized process for analysis, design, implementation and maintenance of semantically interoperable information systems based on formal grammars is discussed in some detail.

  4. A Summary of Proposed Changes to the Current ICARTT Format Standards and their Implications to Future Airborne Studies

    Science.gov (United States)

    Northup, E. A.; Kusterer, J.; Quam, B.; Chen, G.; Early, A. B.; Beach, A. L., III

    2015-12-01

    The current ICARTT file format standards were developed for the purpose of fulfilling the data management needs for the International Consortium for Atmospheric Research on Transport and Transformation (ICARTT) campaign in 2004. The goal of the ICARTT file format was to establish a common and simple to use data file format to promote data exchange and collaboration among science teams with similar science objectives. ICARTT has been the NASA standard since 2010, and is widely used by NOAA, NSF, and international partners (DLR, FAAM). Despite its level of acceptance, there are a number of issues with the current ICARTT format, especially concerning the machine readability. To enhance usability, the ICARTT Refresh Earth Science Data Systems Working Group (ESDSWG) was established to enable a platform for atmospheric science data producers, users (e.g. modelers) and data managers to collaborate on developing criteria for this file format. Ultimately, this is a cross agency effort to improve and aggregate the metadata records being produced. After conducting a survey to identify deficiencies in the current format, we determined which are considered most important to the various communities. Numerous recommendations were made to improve upon the file format while maintaining backward compatibility. The recommendations made to date and their advantages and limitations will be discussed.

  5. Hydroxycarbamine: from an Old Drug Used in Malignant Hemopathies to a Current Standard in Sickle Cell Disease

    Science.gov (United States)

    Cannas, Giovanna; Poutrel, Solène; Thomas, Xavier

    2017-01-01

    While hydroxycarbamide (hydroxyurea, HU) has less and fewer indications in malignant hemopathies, it represents the only widely used drug which modifies sickle cell disease pathogenesis. Clinical experience with HU for patients with sickle cell disease has been accumulated over the past 25 years in Western countries. The review of the literature provides increasing support for safety and efficacy in both children and adults for reducing acute vaso-occlusive events including pain episodes and acute chest syndrome. No increased incidence of leukemia and teratogenicity was demonstrated. HU has become the standard-of-care for sickle cell anemia but remains underused. Barriers to its use should be identified and overcome. PMID:28293403

  6. HYDROXYCARBAMINE: FROM AN OLD DRUG USED IN MALIGNANT HEMOPATHIES TO A CURRENT STANDARD IN SICKLE CELL DISEASE

    Directory of Open Access Journals (Sweden)

    Giovanna Cannas

    2017-02-01

    Full Text Available While hydroxycarbamine (hydroxyurea, HU has less and less indications in malignant hemopathies, it represents the only widely used drug which modifies sickle cell disease pathogenesis. Clinical experience with HU for patients with sickle cell disease has been accumulated over the past 25 years in Western countries. The review of the literature provides increasing support of safety and efficacy in both children and adults for reducing acute vaso-occlusive events including pain episodes and acute chest syndrome. HU has become the standard-of-care for sickle cell anemia, but remains underused. Barriers to its use should be identified and overcome.

  7. The K-nearest neighbor algorithm predicted rehabilitation potential better than current Clinical Assessment Protocol.

    Science.gov (United States)

    Zhu, Mu; Chen, Wenhong; Hirdes, John P; Stolee, Paul

    2007-10-01

    There may be great potential for using computer-modeling techniques and machine-learning algorithms in clinical decision making, if these can be shown to produce results superior to clinical protocols currently in use. We aim to explore the potential to use an automatic, data-driven, machine-learning algorithm in clinical decision making. Using a database containing comprehensive health assessment information (the interRAI-HC) on home care clients (N=24,724) from eight community-care regions in Ontario, Canada, we compare the performance of the K-nearest neighbor (KNN) algorithm and a Clinical Assessment Protocol (the "ADLCAP") currently used to predict rehabilitation potential. For our purposes, we define a patient as having rehabilitation potential if the patient had functional improvement or remained at home over a follow-up period of approximately 1 year. The KNN algorithm has a lower false positive rate in all but one of the eight regions in the sample, and lower false negative rates in all regions. Compared using likelihood ratio statistics, KNN is uniformly more informative than the ADLCAP. This article illustrates the potential for a machine-learning algorithm to enhance clinical decision making.

  8. Web services-based access to local clinical trial databases: a standards initiative of the Association of American Cancer Institutes.

    Science.gov (United States)

    Stahl, Douglas C; Evans, Richard M; Afrin, Lawrence B; DeTeresa, Richard M; Ko, Dave; Mitchell, Kevin

    2003-01-01

    Electronic discovery of the clinical trials being performed at a specific research center is a challenging task, which presently requires manual review of the center's locally maintained databases or web pages of protocol listings. Near real-time automated discovery of available trials would increase the efficiency and effectiveness of clinical trial searching, and would facilitate the development of new services for information providers and consumers. Automated discovery efforts to date have been hindered by issues such as disparate database schemas, vocabularies, and insufficient standards for easy intersystem exchange of high-level data, but adequate infrastructure now exists that make possible the development of applications for near real-time automated discovery of trials. This paper describes the current state (design and implementation) of the Web Services Specification for Publication and Discovery of Clinical Trials as developed by the Technology Task Force of the Association of American Cancer Institutes. The paper then briefly discusses a prototype web service-based application that implements the specification. Directions for evolution of this specification are also discussed.

  9. Theranostic liposomes for cancer diagnosis and treatment: current development and pre-clinical success.

    Science.gov (United States)

    Muthu, Madaswamy S; Feng, Si-Shen

    2013-02-01

    Liposomes are one of the effective drug delivery systems that are developed based on the nanotechnology concept. Liposomal formulation is the first nanomedicine approved by the US FDA for clinical application. Recently, the marketed liposomes and stealth liposomes have made impact for cancer therapy. In addition, a few receptor-targeted liposome products have been in different phases of clinical trials, which are yet to be marketed. In the present editorial, the advantages of vitamin E TPGS-coated liposomes over the currently available PEG-coated liposomes will be described and their great potentials for nanotheranostics for cancer imaging and therapy will be covered.

  10. Standardization, Clinical Validation, and Typicality Norms of a New Test Assessing Semantic Verbal Fluency.

    Science.gov (United States)

    Quaranta, Davide; Caprara, Alessia; Piccininni, Chiara; Vita, Maria G; Gainotti, Guido; Marra, Camillo

    2016-08-01

    Semantic verbal fluency (SVF) tests are widely used in clinical neuropsychology. We propose the standardization and clinical validation of a new SVF test based on the production of names of birds and articles of furniture (Birds and Articles of Furniture test-BAF). A sample of 268 subjects aged 40 years or more underwent the test. The clinical validation was conducted on subjects affected by amnesic Mild Cognitive Impairment (aMCI; N = 106), mild (N = 178), and moderate (N = 114) Alzheimer's disease (AD). The BAF total score was influenced by both age and education, whereas the single scores obtained on BAF were also influenced by gender. The percentage of subjects with pathological score on BAF increased from aMCI (19%) to mild (45.5%) and moderate (71.1%) AD, and receiver operating characteristic curves analysis showed that the BAF may be highly reliable in distinguishing aMCI and AD patients from healthy subjects. We also provide typicality norms for birds and articles of furniture that could be useful in the assessment of qualitative features of words produced in semantic fluency tests. The BAF test could be a valid and reliable tool in both clinical practice and research on subjects affected by cognitive impairment. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  11. Evaluation of current operating standards for chlorine dioxide in disinfection of dump tank and flume for fresh tomatoes.

    Science.gov (United States)

    Tomás-Callejas, Alejandro; López-Velasco, Gabriela; Valadez, Angela M; Sbodio, Adrian; Artés-Hernández, Francisco; Danyluk, Michelle D; Suslow, Trevor V

    2012-02-01

    Standard postharvest unit operations that rely on copious water contact, such as fruit unloading and washing, approach the criteria for a true critical control point in fresh tomato production. Performance data for approved sanitizers that reflect commercial systems are needed to set standards for audit compliance. This study was conducted to evaluate the efficacy of chlorine dioxide (ClO(2)) for water disinfection as an objective assessment of recent industry-adopted standards for dump tank and flume management in fresh tomato packing operations. On-site assessments were conducted during eight temporally distinct shifts in two Florida packinghouses and one California packinghouse. Microbiological analyses of incoming and washed fruit and dump and flume system water were evaluated. Water temperature, pH, turbidity, conductivity, and oxidation-reduction potential (ORP) were monitored. Reduction in populations of mesophilic and coliform bacteria on fruit was not significant, and populations were significantly higher (P dump tanks but consistently below the detection limit in flumes. Turbidity and conductivity increased with loads of incoming tomatoes. Water temperature varied during daily operations, but pH and ORP mostly remained constant. The industry standard positive temperature differential of 5.5°C between water and fruit pulp was not maintained in tanks during the full daily operation. ORP values were significantly higher in the flume than in the dump tank. A positive correlation was found between ORP and temperature, and negative correlations were found between ORP and turbidity, total mesophilic bacteria, and coliforms. This study provides in-plant data indicating that ClO(2) can be an effective sanitizer in flume and spray-wash systems, but current operational limitations restrict its performance in dump tanks. Under current conditions, ClO(2) alone is unlikely to allow the fresh tomato industry to meet its microbiological quality goals under typical

  12. Atopic Dermatitis in Children: Current Clinical Guidelines for Diagnosis and Therapy

    Directory of Open Access Journals (Sweden)

    L. S. Namazova-Baranova

    2016-01-01

    Full Text Available Atopic dermatitis is a chronic multifactorial skin disease that is common enough in childhood. The article presents the current data on epidemiology and dynamics of incidence of pathological symptoms, pathogenesis basics, and key factors of the disease development, shows the current classification of the disease. The authors consider in detail the key principles of the diagnosis and peculiarities of a clinical aspect depending on age. Algorithms of a therapeutic approach, as well as basics of an individual hypoallergenic diet are proposed. General recommendations and possible prognosis for pediatric patients with atopic dermatitis are given.

  13. [Resource activation in clinical psychology and psychotherapy: review of theoretical issues and current research].

    Science.gov (United States)

    Groß, L J; Stemmler, M; de Zwaan, M

    2012-08-01

    This review summarises theoretical issues and current research on working with clients' resources and strengths in clinical psychology and psychotherapy. Resource activation is considered as an important common factor in psychotherapy. In general, resource activation means an explicit focus on resources, strengths and potentials of the clients. After defining the term resources, considerations with regard to therapeutic attitude, principles of resource activation, approaches to resource diagnostics and different research strategies are presented. Current research focuses especially on the relation between resource activation and process variables in out-patient treatment.

  14. Objective standardized clinical assessment with feedback: Adapting the objective structured clinical examination for postgraduate psychiatry training in India

    Directory of Open Access Journals (Sweden)

    Chandra Prabha

    2009-06-01

    Full Text Available Background: The objective structured clinical examination (OSCE is used commonly for assessment of psychiatry trainees but has been used less for teaching. Aim and Setting: This study describes the adaptation of the OSCE method for training purposes in a postgraduate psychiatry training center in India and the initial findings with regard to trainee performance. Materials and Methods : The adapted method was called the objective structured clinical assessment with feedback (OSCAF. The adaptation included several steps - modifying existing OSCE patterns for language and cultural appropriateness, using supervised roleplaying instead of standardized or simulated patients and evolving an assessment method (14-item checklist that would generate feedback. This exercise was conducted in front of a group of multidisciplinary peers and supervisors. Statistical Analysis: Descriptive statistics and ANOVA were used. Results: Analysis of the performance based on the 14-item checklist assessing common elements of any patient-related interaction in 34 different OSCAF tasks indicated the following: less-than-satisfactory (< 75% performances in the following areas - assuring confidentiality (73.5%, assessing comfort (62%, summarizing (60%, closure (62% and checking whether the ′patient′ had understood what was being communicated (42%. Based on the nature of clinical situations, performances on some specific and difficult OSCAF situations were found to be inadequate and indicated need for further training. Conclusions: We have been able to demonstrate OSCAF to be a convenient, cost-effective training method in psychiatry, with limited demands on resources; however, further refinements in ratings and feedback methods and studies on effectiveness may enhance its utility.

  15. Why Current PTH Assays Mislead Clinical Decision Making in Patients with Secondary Hyperparathyroidism.

    Science.gov (United States)

    Hocher, Berthold; Yin, Lianghong

    2017-02-10

    Preclinical studies in cell culture systems as well as in whole animal chronic kidney disease (CKD) models showed that parathyroid hormone (PTH), oxidized at the 2 methionine residues (positions 8 and 18), caused a loss of function. This was so far not considered in the development of PTH assays used in current clinical practice. Patients with advanced CKD are subject to oxidative stress, and plasma proteins (including PTH) are targets for oxidants. In patients with CKD, a considerable but variable fraction (about 70 to 90%) of measured PTH appears to be oxidized. Oxidized PTH (oxPTH) does not interact with the PTH receptor resulting in loss of biological activity. Currently used intact PTH (iPTH) assays detect both oxidized and non-oxPTH (n-oxPTH). Clinical studies demonstrated that bioactive, n-oxPTH, but not iPTH nor oxPTH, is associated with mortality in CKD patients.

  16. Do current clinical trials meet society's needs?: a critical review of recent evidence.

    Science.gov (United States)

    Pocock, Stuart J; Gersh, Bernard J

    2014-10-14

    This paper describes some important controversies regarding the current state of clinical trials research in cardiology. Topics covered include the inadequacy of trial research on medical devices, problems with industry-sponsored trials, the lack of head-to-head trials of new effective treatments, the need for wiser handling of drug safety issues, the credibility (or lack thereof) of trial reports in medical journals, problems with globalization of trials, the role of personalized (stratified) medicine in trials, the need for new trials of old drugs, the need for trials of treatment withdrawal, the importance of pragmatic trials of treatment strategies, and the limitations of observational comparative effectiveness studies. All issues are illustrated by recent topical trials in cardiology. Overall, we explore the extent to which clinical trials, as currently practiced, are successful in meeting society's expectations.

  17. Standardization and utilization of biobank resources in clinical protein science with examples of emerging applications.

    Science.gov (United States)

    Marko-Varga, György; Végvári, Ákos; Welinder, Charlotte; Lindberg, Henrik; Rezeli, Melinda; Edula, Goutham; Svensson, Katrin J; Belting, Mattias; Laurell, Thomas; Fehniger, Thomas E

    2012-11-02

    Biobanks are a major resource to access and measure biological constituents that can be used to monitor the status of health and disease, both in unique individual samples and within populations. Most "omic" activities rely on access to these collections of stored samples to provide the basis for establishing the ranges and frequencies of expression. Furthermore, information about the relative abundance and form of protein constituents found in stored samples provides an important historical index for comparative studies of inherited, epidemic, and developing disease. Standardizations of sample quality, form, and analysis are an important unmet need and requirement for gaining the full benefit from collected samples. Coupled to this standard is the provision of annotation describing clinical status and metadata of measurements of clinical phenotype that characterizes the sample. Today we have not yet achieved consensus on how to collect, manage, and build biobank archives in order to reach goals where these efforts are translated into value for the patient. Several initiatives (OBBR, ISBER, BBMRI) that disseminate best practice examples for biobanking are expected to play an important role in ensuring the need to preserve the sample integrity of biosamples stored for periods that reach one or several decades. These developments will be of great value and importance to programs such as the Chromosome Human Protein Project (C-HPP) that will associate protein expression in healthy and disease states with genetic foci along of each of the human chromosomes.

  18. [Current state of training in pharmacy education using a problem-based learning/tutorial model with simulated patients and standardized patients at National University Corporation].

    Science.gov (United States)

    Irie, Tetsumi; Nitta, Atsumi; Akaike, Akinori

    2012-01-01

    Simulated/standardized patient-based (SP) education and problem-based learning (PBL) tutorial education become a powerful tool to heighten the pharmacy students' will to learn in order to cultivate the responsibility to contribute to public health and welfare as a clinical professional and to facilitate students' competences to solve problems by themselves. What this program is trying to do is: 1) to establish the system to train, educate and supply SP who are effective in the training and education of pharmacy students in close cooperation with the medical schools and their affiliated hospitals; 2) to improve the quality of the current PBL tutorial education and thereby establish it as an advanced education program in the education of senior students. We carried out the questionnaire to National University Corporation which establishes a school of pharmacy, as to the training and education of SP. The analysis of the answers to the questionnaire revealed the present status of SP in the Pharmaceutical Objective Structured Clinical Examination (OSCE) in the Pharmaceutical Common Achievement Test, and the existence of the problems on how to standardize SP as well as how to cover such expenses. Furthermore, the activity of the first year consisted of the exchange and sharing of information regarding the existing method of training and education of SP and PBL tutorial education and the identification of the problems to be solved in order to improve the quality of the educational program.

  19. Exploring Current Sensory Enhancement Practices Within Videofluoroscopic Swallow Study (VFSS) Clinics.

    Science.gov (United States)

    Turkington, Leisa; Nund, Rebecca L; Ward, Elizabeth C; Farrell, Anna

    2017-04-01

    Whilst some research evidence supports the potential benefits of sensory enhancement strategies (SES) in dysphagia management, there is limited understanding of how SES are used in clinical services and the influencing drivers involved in selection during instrumental assessment. SES include modification of temperature, flavour, texture, chemesthetic qualities and bolus size of food/fluid. This study aimed to explore the use of SES within Australian Videofluoroscopic Swallow Study (VFSS) clinics providing adult services, via a qualitative methodology. Maximum variation sampling was used to select a cross section of speech-language pathologists (SLPs) with a range of experience working within 16 VFSS clinics across metropolitan and regional settings to participate in semi-structured, focus group or individual teleconference interviews. Content analysis of interview transcripts was conducted, with four themes emerging as influencing drivers of SES use, including: Patient factors influence SES use; Clinician factors influence SES use; Trials of SES require planning and organisation, and; Organisational barriers impact on SES use. These four themes were all connected through a single integrative theme: Extensive variations of SES procedures exist across clinical settings. Findings indicate that achieving alignment of clinical purpose and implementation of practices amongst VFSS clinicians will be complex given current diversity in SES use. Organisational issues and clinician training need to be addressed, and more research is needed to provide a stronger evidence base to inform clinical practice in this emerging area of dysphagia management.

  20. Current opinion in clinical sport psychology: from athletic performance to psychological well-being.

    Science.gov (United States)

    Moore, Zella E; Bonagura, Kehana

    2017-08-01

    Clinical sport psychology (CSP) is a contemporary, empirically informed model that employs a scope, style, and mode of practice built upon cutting-edge findings from both clinical and sport sciences, and that follows the sound methodological traditions of clinical psychology [1(••)]. Conceptualizing athletic performance and well-being through the context of empirical research in both athletic and nonathletic domains of functioning, CSP practice can involve the enhancement of athletic performance, and also the personal development and psychological well-being of performers. CSP intervention options expand (if desired) to include those currently considered to be outside of the purview of traditional sport psychology and within the domains of clinical/counseling psychology. Importantly, CSP does not imply that its practitioners must choose a population. CSPers can, if appropriate, assess and intervene with psychological disorders, performance dysfunction, and performance improvement, and/or can make appropriate referrals. Despite whether one personally addresses the variety of interpersonal, non-diagnosable, and clinical issues potentially presented, they must support a comprehensive, client-specific approach and engage in interventions based on sound evidence. Expanding practice boundaries, and with it one's roles and responsibilities, also results in expanded job opportunities. This scope highlights the clinical sport psychologist as the human behavior expert in the athletic milieu. Copyright © 2017 Elsevier Ltd. All rights reserved.

  1. Oncologic Photodynamic Therapy: Basic Principles, Current Clinical Status and Future Directions

    Science.gov (United States)

    van Straten, Demian; Mashayekhi, Vida; de Bruijn, Henriette S.; Oliveira, Sabrina; Robinson, Dominic J.

    2017-01-01

    Photodynamic therapy (PDT) is a clinically approved cancer therapy, based on a photochemical reaction between a light activatable molecule or photosensitizer, light, and molecular oxygen. When these three harmless components are present together, reactive oxygen species are formed. These can directly damage cells and/or vasculature, and induce inflammatory and immune responses. PDT is a two-stage procedure, which starts with photosensitizer administration followed by a locally directed light exposure, with the aim of confined tumor destruction. Since its regulatory approval, over 30 years ago, PDT has been the subject of numerous studies and has proven to be an effective form of cancer therapy. This review provides an overview of the clinical trials conducted over the last 10 years, illustrating how PDT is applied in the clinic today. Furthermore, examples from ongoing clinical trials and the most recent preclinical studies are presented, to show the directions, in which PDT is headed, in the near and distant future. Despite the clinical success reported, PDT is still currently underutilized in the clinic. We also discuss the factors that hamper the exploration of this effective therapy and what should be changed to render it a more effective and more widely available option for patients. PMID:28218708

  2. Oncologic Photodynamic Therapy: Basic Principles, Current Clinical Status and Future Directions

    Directory of Open Access Journals (Sweden)

    Demian van Straten

    2017-02-01

    Full Text Available Photodynamic therapy (PDT is a clinically approved cancer therapy, based on a photochemical reaction between a light activatable molecule or photosensitizer, light, and molecular oxygen. When these three harmless components are present together, reactive oxygen species are formed. These can directly damage cells and/or vasculature, and induce inflammatory and immune responses. PDT is a two-stage procedure, which starts with photosensitizer administration followed by a locally directed light exposure, with the aim of confined tumor destruction. Since its regulatory approval, over 30 years ago, PDT has been the subject of numerous studies and has proven to be an effective form of cancer therapy. This review provides an overview of the clinical trials conducted over the last 10 years, illustrating how PDT is applied in the clinic today. Furthermore, examples from ongoing clinical trials and the most recent preclinical studies are presented, to show the directions, in which PDT is headed, in the near and distant future. Despite the clinical success reported, PDT is still currently underutilized in the clinic. We also discuss the factors that hamper the exploration of this effective therapy and what should be changed to render it a more effective and more widely available option for patients.

  3. Lung scintigraphy in the diagnosis of pulmonary embolism: current methods and interpretation criteria in clinical practice

    OpenAIRE

    Skarlovnik, Ajda; Hrastnik, Damjana; Fettich, Jure; Grmek, Marko

    2014-01-01

    Background In current clinical practice lung scintigraphy is mainly used to exclude pulmonary embolism (PE). Modified diagnostic criteria for planar lung scintigraphy are considered, as newer scitigraphic methods, especially single photon emission computed tomography (SPECT) are becoming more popular. Patients and methods. Data of 98 outpatients who underwent planar ventilation/perfusion (V/Q) scintigraphy and 49 outpatients who underwent V/Q SPECT from the emergency department (ED) were retr...

  4. Are the current attempts at standardization of antiphospholipid antibodies still useful? Emerging technologies signal a shift in direction.

    Science.gov (United States)

    Andreoli, Laura; Rizzini, Silvia; Allegri, Flavio; Meroni, Pierluigi; Tincani, Angela

    2008-06-01

    The pathogenic role of antiphospholipid antibodies (aPL) has been widely established over past years in several experimental models and clinical studies. Accordingly, the detection of aPL by immunoassays (anticardiolipin antibodies; anti-beta2 glycoprotein I antibodies) has become a routine practice in the clinical workup of patients with systemic autoimmune diseases. aPL are mostly assayed using commercial ELISA kits, whose performance has not been found to be sufficiently concordant among the different manufacturers. In the past years, collaborative groups have spent considerable effort to reach some form of standardization but this process is still ongoing. Such lack of standardization has recently become even more crucial, as manufacturers have had to face an increasing demand for fully automated tests for aPL, like those test systems that have been developed for other autoantibodies (e.g., antinuclear antibodies, anti-ENA antibodies). We therefore report our recent experience with two newly developed automated methods for anticardiolipin antibodies testing. In particular, we discuss the results obtained using routine samples, as we believe that these better reflect the "real-life" situation in which those automated methods will operate. We also mention other emerging technologies in the field of aPL detection.

  5. The standardization therapeutics of ischemic stroke the clinical analysis of 312 patients with stoke

    Institute of Scientific and Technical Information of China (English)

    Dong Qiang; Fang Xin; Hun Xiang

    2000-01-01

    Objective: To study the outcome after the standardization therapeutics of ischemic stroke and the relatively factors which can influence the outcome of patients with stroke. Methods: Using data collected from 312 patients enrolled in the clinical standardization therapeutics trial, and neurological impairment at the hospitalization and the discharge was quantified using the China Stroke Scale (CSS), the outcome at the discharge using the percentage of CSS decreasing. The outcome was rated as cure if the percentage of CSS decreasing was over 89% and dead. Analyses were adjusted for age, history of previous disorders, and the form of onset, blood pressure at onset, complication. Results: The percentage of cure after the thrombolysis was 12.5%, after anticoagulant was 8.23%, after decreasing fibrinogen was 8.57% and after the convention treatment was only 5.66%. And at the same time, the percentage of dead after the thrombolysis was 12.5%, after anticoagulant was 8.23%, after decreasing fibrinogen was 8.57% and after the convention treatment was 10.1%. The other factors had no differently between the variability treatments. The complication could influence the outcome of stroke patients, especially the infect of respiratory, disturbance of kidney and electrolyte. Conclusions: The standardization therapeutics should be contributing the outcome of patients with ischemic stroke.

  6. Proton therapy for head and neck cancer: Rationale, potential indications, practical considerations, and current clinical evidence

    Energy Technology Data Exchange (ETDEWEB)

    Mendenhall, Nancy P.; Malyapa, Robert S.; Su, Zhong; Yeung, Daniel; Mendenhall, William M.; Li, Zuofeng (Univ. of Florida Proton Therapy Inst., Jacksonville, Florida (United States)), e-mail: menden@shands.ufl.edu

    2011-08-15

    There is a strong rationale for potential benefits from proton therapy (PT) for selected cancers of the head and neck because of the opportunity to improve the therapeutic ratio by improving radiation dose distributions and because of the significant differences in radiation dose distribution achievable with x-ray-based radiation therapy (RT) and PT. Comparisons of dose distributions between x-ray-based and PT plans in selected cases show specific benefits in dose distribution likely to translate into improved clinical outcomes. However, the use of PT in head and neck cancers requires special considerations in the simulation and treatment planning process, and currently available PT technology may not permit realization of the maximum potential benefits of PT. To date, few clinical data are available, but early clinical experiences in sinonasal tumors in particular suggest significant improvements in both disease control and radiation-related toxicity

  7. Hypertrophic pachymeningitis: Current criteria for diagnosis and differentiation (Clinical case and review of literature

    Directory of Open Access Journals (Sweden)

    E. G. Mendelevich

    2015-01-01

    Full Text Available The paper describes a 44-year-old male patient with an about 6-year history of hypertrophic pachymeningitis. The major clinical symptoms were characterized by headache, exophthalmos, and blindness in one eye. The data for differential diagnosis of the disease are given. The current literature on the clinical manifestations of hypertrophic pachymeningitis, its differential diagnosis, and the results of magnetic resonance imaging (MRI is reviewed. Diagnostic difficulties at the stage of a clinical observation are due to the nonspecificity of neurological manifestations and the need for a comprehensive examination to detect a somatic disease. MRI can diagnose the disease-specific phenomenon of damage to the meninges, which calls for further careful differentiation. Clinicians must be familiar with alternative differential diagnosis, as a rapid specific therapeutic approach will help avoid long-term or irreversible neurological complications.

  8. ENTEROVIRUS INFECTION IN CHILDREN: CLINICAL AND EPIDEMIOLOGICAL FEATURES AT THE CURRENT STAGE

    Directory of Open Access Journals (Sweden)

    G. P. Martynova

    2016-01-01

    Full Text Available The article presents the current clinical and epidemiological features of enterovirus infection in children of Krasnoyarsk Territory. A retrospective analysis of the incidence of enterovirus infection and enterovirus meningitis in the period 2014—2015 according to the forms of state statistical reporting №2 «Information on infectious and parasitic diseases». Clinical and epidemiological analysis of enterovirus infection in 454 children who were treated at MBUZ «City Children's Infectious Hospital №1» in the period of seasonal rise of morbidity in 2014 revealed a prevalence of etiological structure of enteroviruses Coxsackie B, Coxsackie B5, Coxsackie B3, Coxsackie B4. The region recorded the different clinical forms of enterovirus infection (rash, myalgia, diarrhea, gerpangina, the structure of which is still, aseptic meningitis prevails.

  9. Developing genomic knowledge bases and databases to support clinical management: current perspectives.

    Science.gov (United States)

    Huser, Vojtech; Sincan, Murat; Cimino, James J

    2014-01-01

    Personalized medicine, the ability to tailor diagnostic and treatment decisions for individual patients, is seen as the evolution of modern medicine. We characterize here the informatics resources available today or envisioned in the near future that can support clinical interpretation of genomic test results. We assume a clinical sequencing scenario (germline whole-exome sequencing) in which a clinical specialist, such as an endocrinologist, needs to tailor patient management decisions within his or her specialty (targeted findings) but relies on a genetic counselor to interpret off-target incidental findings. We characterize the genomic input data and list various types of knowledge bases that provide genomic knowledge for generating clinical decision support. We highlight the need for patient-level databases with detailed lifelong phenotype content in addition to genotype data and provide a list of recommendations for personalized medicine knowledge bases and databases. We conclude that no single knowledge base can currently support all aspects of personalized recommendations and that consolidation of several current resources into larger, more dynamic and collaborative knowledge bases may offer a future path forward.

  10. Nationwide survey for current clinical status of amniocentesis and maternal serum marker test in Japan.

    Science.gov (United States)

    Miyake, Hidehiko; Yamada, Shigehito; Fujii, Yosuke; Sawai, Hideaki; Arimori, Naoko; Yamanouchi, Yasuko; Ozasa, Yuka; Kanai, Makoto; Sago, Haruhiko; Sekizawa, Akihiko; Takada, Fumio; Masuzaki, Hideaki; Matsubara, Yoichi; Hirahara, Fumiki; Kugu, Koji

    2016-10-01

    Prenatal testing has been provided in Japan over the past several decades. However, it is difficult to assess the clinical status of amniocentesis (AC) and maternal serum markers (MSM) because obstetricians can perform these tests without registration. This study aims to investigate the current clinical status of AC and MSM in Japan. We conducted a questionnaire study that was intended for a total of 5622 Japanese obstetrics/gynecology facilities during October 2013 to January 2014. The response rate was 40.8% (2295/5622). Of the 2295 facilities, 864 performed MSM (37.7%), 619 performed AC (27.0%) and 412 performed both (18.0%). The average number of MSM tests was 2.0 per month (range 0-52), and the average number of AC tests was 2.4 per month (range 0-30). Involvement of genetic professionals, such as clinical geneticists (CGs) and certified genetic counselors (CGCs), contribute to a content-rich explanation and management of difficult issues and lengthened the explanation time. Nevertheless, relatively few facilities employed these specialists (MSM: 96/864 and AC: 128/619). This is the first study to highlight the current clinical status of AC and MSM tests in Japan. Active involvement of CGs and CGCs can provide more appropriate genetic counseling for prenatal tests.

  11. Relationship of Clinical and Pathologic Nodal Staging in Locally Advanced Breast Cancer: Current Controversies in Daily Practice?

    Science.gov (United States)

    De Felice, Francesca; Musio, Daniela; Bulzonetti, Nadia; Raffetto, Nicola; Tombolini, Vincenzo

    2014-01-01

    Systemic neo-adjuvant therapy plays a primary role in the management of locally advanced breast cancer. Without having any negative effect in overall survival, induction chemotherapy potentially assures a surgery approach in unresectable disease or a conservative treatment in technically resectable disease and acts on a well-vascularized tumor bed, without the modifications induced by surgery. A specific issue has a central function in the neo-adjuvant setting: lymph nodes status. It still represents one of the strongest predictors of long-term prognosis in breast cancer. The discussion of regional radiation therapy should be a matter of debate, especially in a pathological complete response. Currently, the indication for radiotherapy is based on the clinical stage before the surgery, even for the irradiation of the loco-regional lymph nodes. Regardless of pathological down-staging, radiation therapy is accepted as standard adjuvant treatment in locally advanced breast cancer. PMID:25247013

  12. "Good samples make good assays" – the problem of sourcing clinical samples for a standardization project.

    Science.gov (United States)

    Van Houcke, Sofie K; Thienpont, Linda M

    2013-05-01

    Clinical samples are the cornerstone in all aspects related to in vitro diagnostic testing. They are particularly valuable in the process of establishing/validating metrological traceability, because they eliminate commutability issues potentially associated with artificial calibrators. Therefore, they are essential for IFCC standardization projects. However, sourcing clinical specimens is particularly challenging. It mostly turns out that only dedicated supply sources can accommodate the varying specifications within reasonable timelines. Here we describe the torturous experience in this regard of the IFCC Working Group for Standardization of Thyroid Function tests (since transformed into a Committee). We always focused on obtaining high quality samples in sufficient volume to serve all project participants. We applied a step-up approach: in phase I, we used high volume (200 mL of plasma/serum) single donations from apparently healthy individuals, and switched in phase II and III to medium-sized volume clinical samples (15 – 30 mL) from well-defined patient categories. In the first two phases we observed for some assays a sample-related discrepant analytical performance for total/free triiodothyronine and thyroid stimulating hormone (TSH), whereas in phase III we faced a severe delay in obtaining the relevant panels for free thyroxine (FT4) and TSH (n = 90 and n = 100, respectively). Additional experiments only allowed us to exclude hypothesized causes of the observations. We believe that there would be merit in a collaborative effort by chairholders of similar projects to establish a sample procurement infrastructure based on a solid relationship with commercial supply sources with the support of a significant number of committed clinicians.

  13. National turnaround time survey: professional consensus standards for optimal performance and thresholds considered to compromise efficient and effective clinical management.

    Science.gov (United States)

    McKillop, Derek J; Auld, Peter

    2017-01-01

    Background Turnaround time can be defined as the time from receipt of a sample by the laboratory to the validation of the result. The Royal College of Pathologists recommends that a number of performance indicators for turnaround time should be agreed with stakeholders. The difficulty is in arriving at a goal which has some evidence base to support it other than what may simply be currently achievable technically. This survey sought to establish a professional consensus on the goals and meaning of targets for laboratory turnaround time. Methods A questionnaire was circulated by the National Audit Committee to 173 lead consultants for biochemistry in the UK. The survey asked each participant to state their current target turnaround time for core investigations in a broad group of clinical settings. Each participant was also asked to provide a professional opinion on what turnaround time would pose an unacceptable risk to patient safety for each departmental category. A super majority (2/3) was selected as the threshold for consensus. Results The overall response rate was 58% ( n = 100) with a range of 49-72% across the individual Association for Clinical Biochemistry and Laboratory Medicine regions. The consensus optimal turnaround time for the emergency department was 2 h considered unacceptable. The times for general practice and outpatient department were 48 h and for Wards 12 h, respectively. Conclusions We consider that the figures provide a useful benchmark of current opinion, but clearly more empirical standards will have to develop alongside other aspects of healthcare delivery.

  14. Impact of penicillin nonsusceptibility on clinical outcomes of patients with nonmeningeal Streptococcus pneumoniae bacteremia in the era of the 2008 clinical and laboratory standards institute penicillin breakpoints.

    Science.gov (United States)

    Choi, Seong-Ho; Chung, Jin-Won; Sung, Heungsup; Kim, Mi-Na; Kim, Sung-Han; Lee, Sang-Oh; Kim, Yang Soo; Woo, Jun Hee; Choi, Sang-Ho

    2012-09-01

    To investigate the impact of penicillin nonsusceptibility on clinical outcomes of patients with nonmeningeal Streptococcus pneumoniae bacteremia (SPB), a retrospective cohort study was performed. The characteristics of 39 patients with penicillin-nonsusceptible SPB (PNSPB) were compared to those of a group of age- and sex-matched patients (n = 78) with penicillin-susceptible SPB (PSSPB). Susceptibility to penicillin was redetermined by using the revised Clinical and Laboratory Standards Institute (CLSI) penicillin breakpoints in CLSI document M100-S18. Although the PNSPB group tended to have more serious initial manifestations than the PSSPB group, the two groups did not differ significantly in terms of their 30-day mortality rates (30.8% versus 23.1%; P = 0.37) or the duration of hospital stay (median number of days, 14 versus 12; P = 0.89). Broad-spectrum antimicrobial agents, such as extended-spectrum cephalosporins, vancomycin, and carbapenem, were frequently used in both the PNSPB and PSSPB groups. Multivariate analysis revealed that ceftriaxone nonsusceptibility (adjusted odds ratio [aOR] = 4.88; 95% confidence interval [CI] = 1.07 to 22.27; P = 0.041) was one of the independent risk factors for 30-day mortality. Thus, when the 2008 CLSI penicillin breakpoints are applied and the current clinical practice of using wide-spectrum empirical antimicrobial agents is pursued, fatal outcomes in patients with nonmeningeal SPB that can be attributed to penicillin nonsusceptibility are likely to be rare. Further studies that examine the clinical impact of ceftriaxone nonsusceptibility in nonmningeal SPB may be warranted.

  15. Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence

    Science.gov (United States)

    Citarda, F; Tomaselli, G; Capocaccia, R; Barcherini, S; Crespi, M; Group, T. I.

    2001-01-01

    BACKGROUND—Colorectal cancer is one of the leading causes of death from cancer in Western countries. Removal of adenomas is based on the assumption that it could lead to a reduction in the incidence of colorectal cancer, as demonstrated by the National Polyp Study in the USA. A critical issue is whether the benefit observed in clinical trials can also be observed in standard clinical practice. To address the issue, a multicentre Italian collaborative study was organised.
METHODS—The study cohort comprised 1693 subjects of both sexes, aged 40-69 years, enrolled between 1980 and 1987 following a total colon examination (TCE) (that is, total colonoscopy or colonoscopy and double contrast barium enema), with removal of at least one adenoma larger than 5 mm in diameter. Exclusion criteria were genetic syndromes, previous adenomas or colorectal cancer, previous colonic resection, inflammatory bowel disease, or sessile adenomas more than 3 cm in diameter. Follow up ended in December 1996 by TCE or telephone interview, and review of the medical records, clinical files, or death certificates. Incidence ratios for colorectal cancer were compared with expected age and sex specific incidences in the Italian general population.
RESULTS—Follow up data were obtained for 97.3% of cases for a total of 14 211 person/years. Mean follow up was 10.5 years. Six colorectal cancer cases (four in males, two in females) at various stages were ascertained (one at 29 months, two at five years, one at seven years, one at eight years, and one at 10 years from the index examination). The number of cancers expected in the reference population was 17.7 for an incidence ratio of 0.34 (confidence interval 0.23-0.63; p<0.01).
CONCLUSIONS—Colonoscopic polypectomy substantially reduced the incidence of colorectal cancer in the cohort compared with that expected in the general population. These results are of particular relevance considering that those with adenomas are at

  16. The emergence of international food safety standards and guidelines: understanding the current landscape through a historical approach.

    Science.gov (United States)

    Ramsingh, Brigit

    2014-07-01

    Following the Second World War, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) teamed up to construct an International Codex Alimentarius (or 'food code') which emerged in 1963. The Codex Committee on Food Hygiene (CCFH) was charged with the task of developing microbial hygiene standards, although it found itself embroiled in debate with the WHO over the nature these standards should take. The WHO was increasingly relying upon the input of biometricians and especially the International Commission on Microbial Specifications for Foods (ICMSF) which had developed statistical sampling plans for determining the microbial counts in the final end products. The CCFH, however, was initially more focused on a qualitative approach which looked at the entire food production system and developed codes of practice as well as more descriptive end-product specifications which the WHO argued were 'not scientifically correct'. Drawing upon historical archival material (correspondence and reports) from the WHO and FAO, this article examines this debate over microbial hygiene standards and suggests that there are many lessons from history which could shed light upon current debates and efforts in international food safety management systems and approaches.

  17. Upgrade of the ESA DRAMA OSCAR Tool: Analysis of Disposal Strategies Considering Current Standards for Future Solar and Geomagnetic Activity

    Science.gov (United States)

    Braun, V.; Sanchez-Ortiz, N.; Gelhaus, J.; Kebschull, C.; Flegel, S.; Mockel, M.; Wiedemann, C.; Krag, H.; Vorsmann, P.

    2013-08-01

    In 2008 the UN General Assembly adopted resolution 62/217, endorsing the space debris mitigation guidelines (SDMG) of the UN Committee on the Peaceful Uses of Outer Space (UNCOPUOS). These guidelines contain recommendations for satellite operators to implement measures for various mission phases in order to reduce the further accumulation of space debris in space and especially within the protected regions. These are defined within the SDMG as being the LEO region (up to 2,000 km altitude) and the GEO region (∼200 km in altitude around the GEO altitude and ∼15 degrees latitude). In the first version of ESA's DRAMA tool suite, OSCAR (Orbital SpaceCraft Active Removal) was designed as a tool to allow users the analysis of different disposal stragies for spacecraft in the LEO and GEO region. The upgrade of the ESA DRAMA tool suite by TUBS and DEIMOS under ESA/ESOC contract included the development of a renewed version of the existing OSCAR tool, allowing in its current version the consideration of different future solar and geomagnetic activity scenarios and besides the already known disposal systems (chemical and electric propulsion, as well as electrodynamic tether) the analysis of the orbital evolution using drag augmentation devices. One of the primary goals was to implement techniques recommended by current standards. The recommendations from the SDMG were used for the definition of the critical regions as well as compliance criteria, the user may check his disposal strategy against. For satellites operating in GEO, the ISO 26872:2010 (Space Systems - Disposal of satellites operating at geosynchronous altitude) standard was accounted for. For the generation of future solar and geomagnetic activity, the standards ISO 27852:2011 (Space Systems -Estimation of orbit lifetime) and the ECSS-E-ST-10-04C (Space engineering - Space environment) have been considered and recommended modeling approaches were implemented. In this paper, the OSCAR tool is presented, giving

  18. Current research on cigarette toxicity: critical appraisal in view of clinical laboratory

    Directory of Open Access Journals (Sweden)

    Prajwal Gyawali

    2016-06-01

    Full Text Available Cigarette smoking has been implicated as a potential risk factor for development and progression of chronic obstructive pulmonary disease (COPD and cardiovascular disease (CVD, including ischemic heart disease. Although, several methods are in existence to measuring cigarette toxicity, evidence regarding adoption of a gold standard technique is still imprecise. In this study, we reviewed articles describing methods of measuring cigarette toxicity in relation to clinical laboratory practice. A critical analysis of the benefits and limitations of each method in relation to low-middle income countries is discussed. [Int J Res Med Sci 2016; 4(6.000: 1785-1793

  19. Clinical Skills and Professionalism: Assessing Orthopaedic Residents With Unannounced Standardized Patients.

    Science.gov (United States)

    Taormina, David P; Zuckerman, Joseph D; Karia, Raj; Zabar, Sondra; Egol, Kenneth A; Phillips, Donna P

    2017-09-06

    We developed a series of orthopedic unannounced standardized patient (USP) encounters for the purpose of objective assessment of residents during clinic encounters. Consecutive case-series. NYU-Langone Multi-center Academic University Hospital System. NYU-Langone/Hospital for Joint Diseases Orthopedic Surgery residents; 48 consecutive residents assessed. Four orthopedic cases were developed. USPs presented themselves as patients in outpatient clinics. Residents were evaluated on communication skills (information gathering, relationship development, and education and counseling). USPs globally rated whether they would recommend the resident. Forty-eight USP encounters were completed over a 2-year period. Communication skills items were rated at 51% (±30) "well done." Education and counseling skills were rated as the lowest communication domain at 33% (±33). Residents were globally recommended based on communication skills in 63% of the encounters recommended in 70% of encounters based on both professionalism and medical competence. The USP program has been useful in assessing residents' clinical skills, interpersonal and communications skills, and professionalism. Use of USP in orthopedic surgery training programs can be an objective means for trainee assessment. Copyright © 2017. Published by Elsevier Inc.

  20. Qualitative research within trials: developing a standard operating procedure for a clinical trials unit

    Science.gov (United States)

    2013-01-01

    Background Qualitative research methods are increasingly used within clinical trials to address broader research questions than can be addressed by quantitative methods alone. These methods enable health professionals, service users, and other stakeholders to contribute their views and experiences to evaluation of healthcare treatments, interventions, or policies, and influence the design of trials. Qualitative data often contribute information that is better able to reform policy or influence design. Methods Health services researchers, including trialists, clinicians, and qualitative researchers, worked collaboratively to develop a comprehensive portfolio of standard operating procedures (SOPs) for the West Wales Organisation for Rigorous Trials in Health (WWORTH), a clinical trials unit (CTU) at Swansea University, which has recently achieved registration with the UK Clinical Research Collaboration (UKCRC). Although the UKCRC requires a total of 25 SOPs from registered CTUs, WWORTH chose to add an additional qualitative-methods SOP (QM-SOP). Results The qualitative methods SOP (QM-SOP) defines good practice in designing and implementing qualitative components of trials, while allowing flexibility of approach and method. Its basic principles are that: qualitative researchers should be contributors from the start of trials with qualitative potential; the qualitative component should have clear aims; and the main study publication should report on the qualitative component. Conclusions We recommend that CTUs consider developing a QM-SOP to enhance the conduct of quantitative trials by adding qualitative data and analysis. We judge that this improves the value of quantitative trials, and contributes to the future development of multi-method trials. PMID:23433341

  1. Development of Standardized Clinical Assessment and Management Plans (SCAMPs) in Plastic and Reconstructive Surgery.

    Science.gov (United States)

    Caterson, Stephanie A; Singh, Mansher; Orgill, Dennis; Ghazinouri, Roya; Han, Elizabeth; Ciociolo, George; Laskowski, Karl; Greenberg, Jeffery O

    2015-09-01

    With rising cost of healthcare, there is an urgent need for developing effective and economical streamlined care. In clinical situations with limited data or conflicting evidence-based data, there is significant institutional and individual practice variation. Quality improvement with the use of Standardized Clinical Assessment and Management Plans (SCAMPs) might be beneficial in such scenarios. The SCAMPs method has never before been reported to be utilized in plastic surgery. The topic of immediate breast reconstruction was identified as a possible SCAMPs project. The initial stages of SCAMPs development, including planning and implementation, were entered. The SCAMP Champion, along with the SCAMPs support team, developed targeted data statements. The SCAMP was then written and a decision-tree algorithm was built. Buy-in was obtained from the Division of Plastic Surgery and a SCAMPs data form was generated to collect data. Decisions pertaining to "immediate implant-based breast reconstruction" were approved as an acceptable topic for SCAMPs development. Nine targeted data statements were made based on the clinical decision points within the SCAMP. The SCAMP algorithm, and the SDF, required multiple revisions. Ultimately, the SCAMP was effectively implemented with multiple iterations in data collection. Full execution of the SCAMP may allow better-defined selection criteria for this complex patient population. Deviations from the SCAMP may allow for improvement of the SCAMP and facilitate consensus within the Division. Iterative and adaptive quality improvement utilizing SCAMPs creates an opportunity to reduce cost by improving knowledge about best practice.

  2. Teaching alternatives to the standard inferior alveolar nerve block in dental education: outcomes in clinical practice.

    Science.gov (United States)

    Johnson, Thomas M; Badovinac, Rachel; Shaefer, Jeffry

    2007-09-01

    Surveys were sent to Harvard School of Dental Medicine students and graduates from the classes of 2000 through 2006 to determine their current primary means of achieving mandibular anesthesia. Orthodontists and orthodontic residents were excluded. All subjects received clinical training in the conventional inferior alveolar nerve block and two alternative techniques (the Akinosi mandibular block and the Gow-Gates mandibular block) during their predoctoral dental education. This study tests the hypothesis that students and graduates who received training in the conventional inferior alveolar nerve block, the Akinosi mandibular block, and the Gow-Gates mandibular block will report more frequent current utilization of alternatives to the conventional inferior alveolar nerve block than clinicians trained in the conventional technique only. At the 95 percent confidence level, we estimated that between 3.7 percent and 16.1 percent (mean=8.5 percent) of clinicians trained in using the Gow-Gates technique use this injection technique primarily, and between 35.4 percent and 56.3 percent (mean=47.5 percent) of those trained in the Gow-Gates method never use this technique. At the same confidence level, between 0.0 percent and 3.8 percent (mean=0.0 percent) of clinicians trained in using the Akinosi technique use this injection clinical technique primarily, and between 62.2 percent and 81.1 percent (mean=72.3 percent) of those trained in the Akinosi method never use this technique. No control group that was completely untrained in the Gow-Gates or Akinosi techniques was available for comparison. However, we presume that zero percent of clinicians who have not been trained in a given technique will use the technique in clinical practice. The confidence interval for the Gow-Gates method excludes this value, while the confidence interval for the Akinosi technique includes zero percent. We conclude that, in the study population, formal clinical training in the Gow-Gates and

  3. Nicotine at clinically relevant concentrations affects atrial inward rectifier potassium current sensitive to acetylcholine.

    Science.gov (United States)

    Bébarová, Markéta; Matejovič, Peter; Švecová, Olga; Kula, Roman; Šimurdová, Milena; Šimurda, Jiří

    2017-02-03

    Nicotine abuse is associated with variety of diseases including arrhythmias, most often atrial fibrillation (AF). Altered inward rectifier potassium currents including acetylcholine-sensitive current I K(Ach) are known to be related to AF pathogenesis. Since relevant data are missing, we aimed to investigate I K(Ach) changes at clinically relevant concentrations of nicotine. Experiments were performed by the whole cell patch clamp technique at 23 ± 1 °C on isolated rat atrial myocytes. Nicotine was applied at following concentrations: 4, 40 and 400 nM; ethanol at 20 mM (∼0.09%). Nicotine at 40 and 400 nM significantly activated constitutively active component of I K(Ach) with the maximum effect at 40 nM (an increase by ∼100%); similar effect was observed at -110 and -50 mV. Changes at 4 nM nicotine were negligible on average. Coapplication of 40 nM nicotine and 20 mM ethanol (which is also known to activate this current) did not show cumulative effect. In the case of acetylcholine-induced component of I K(Ach), a dual effect of nicotine and its correlation with the current magnitude in control were apparent: the current was increased by nicotine in the cells showing small current in control and vice versa. The effect of 40 and 400 nM nicotine on acetylcholine-induced component of I K(Ach) was significantly different at -110 and -50 mV. We conclude that nicotine at clinically relevant concentrations significantly increased constitutively active component of I K(Ach) and showed a dual effect on its acetylcholine-induced component, similarly as ethanol. Synchronous application of nicotine and ethanol did not cause additive effect.

  4. Stem cells for clinical use in cardiovascular medicine: current limitations and future perspectives.

    Science.gov (United States)

    Menasché, Philippe

    2005-10-01

    Cell transplantation is currently gaining a growing interest as a potential new means of improving the prognosis of patients with cardiac failure. The basic assumption is that left ventricular dysfunction is largely due to the loss of a critical number of cardiomyocytes and that it can be partly reversed by implantation of new contractile cells into the postinfarction scars. Primarily for practical reasons, autologous skeletal myoblasts have been the first to undergo clinical trials and now that the feasibility of the procedure is well established, efficacy data are expected from the ongoing randomized studies. Bone marrow stem cells are also generating a great deal of interest, particularly in patients with acute myocardial infarction, and are currently undergoing extensive clinical testing although recent data have raised a cautionary note about the transdifferentiation potential of these cells. While experimental studies and early-phase clinical trials tend to support the concept that cell therapy may enhance cardiac repair, several key issues still need to be addressed including (1) the optimal type of donor cells in relation to the clinical profile of the patients, (2) the mechanism by which cell engraftment improves cardiac function, (3) the optimization of cell survival, (4) the development of less invasive cell delivery techniques and (5) the potential benefits of cell transplantation in nonischemic heart failure. Current evidence suggests, however, that adult stem cells (myogenic or marrow-derived) fail to electromechanically integrate within the recipient heart, thereby mandating the search for second generation cell types able to achieve this goal which is the prerequisite for an effective enhancement of contractile function. Preliminary data suggest that cells that feature a true cardiomyogenic phenotype such as cardiac stem cells and cardiac-precommitted embryonic stem cells may fall in this category and carry the potential for ensuring a true

  5. Standards for Clinical Trials in Male and Female Sexual Dysfunction: I. Phase I to Phase IV Clinical Trial Design.

    Science.gov (United States)

    Fisher, William A; Gruenwald, Ilan; Jannini, Emmanuele A; Lev-Sagie, Ahinoam; Lowenstein, Lior; Pyke, Robert E; Reisman, Yakov; Revicki, Dennis A; Rubio-Aurioles, Eusebio

    2016-12-01

    This series of articles outlines standards for clinical trials of treatments for male and female sexual dysfunctions, with a focus on research design and patient-reported outcome assessment. These articles consist of revision, updating, and integration of articles on standards for clinical trials in male and female sexual dysfunction from the 2010 International Consultation on Sexual Medicine developed by the authors as part of the 2015 International Consultation on Sexual Medicine. We are guided in this effort by several principles. In contrast to previous versions of these guidelines, we merge discussion of standards for clinical trials in male and female sexual dysfunction in an integrated approach that emphasizes the common foundational practices that underlie clinical trials in the two settings. We present a common expected standard for clinical trial design in male and female sexual dysfunction, a common rationale for the design of phase I to IV clinical trials, and common considerations for selection of study population and study duration in male and female sexual dysfunction. We present a focused discussion of fundamental principles in patient- (and partner-) reported outcome assessment and complete this series of articles with specific discussions of selected aspects of clinical trials that are unique to male and to female sexual dysfunction. Our consideration of standards for clinical trials in male and female sexual dysfunction attempts to embody sensitivity to existing and new regulatory guidance and to address implications of the evolution of the diagnosis of sexual dysfunction that have been brought forward in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. The first article in this series focuses on phase I to phase IV clinical trial design considerations. Subsequent articles in this series focus on the measurement of patient-reported outcomes, unique aspects of clinical trial design for men, and unique aspects of clinical

  6. Neuroimaging in Alzheimer's disease: current role in clinical practice and potential future applications

    Directory of Open Access Journals (Sweden)

    Luiz Kobuti Ferreira

    2011-01-01

    Full Text Available 'Alzheimer's disease is the most common cause of dementia and its prevalence is expected to increase in the coming years. Therefore, accurate diagnosis is crucial for patients, clinicians and researchers. Neuroimaging techniques have provided invaluable information about Alzheimer's disease and, owing to recent advances, these methods will have an increasingly important role in research and clinical practice. The purpose of this article is to review recent neuroimaging studies of Alzheimer's disease that provide relevant information to clinical practice, including a new modality: in vivo amyloid imaging. Magnetic resonance imaging, single photon emission computed tomography and 18F-fluorodeoxyglucose-positron emission tomography are currently available for clinical use. Patients with suspected Alzheimer's disease are commonly investigated with magnetic resonance imaging because it provides detailed images of brain structure and allows the identification of supportive features for the diagnosis. Neurofunctional techniques such as single photon emission computed tomography and 18F-fluorodeoxyglucose-positron emission tomography can also be used to complement the diagnostic investigation in cases of uncertainty. Amyloid imaging is a non-invasive technique that uses positron emission tomography technology to investigate the accumulation of the β-amyloid peptide in the brain, which is a hallmark of Alzheimer's disease. This is a promising test but currently its use is restricted to very few specialized research centers in the world. Technological innovations will probably increase its availability and reliability, which are the necessary steps to achieve robust clinical applicability. Thus, in the future it is likely that amyloid imaging techniques will be used in the clinical evaluation of patients with Alzheimer's disease.

  7. Current Clinical Applications and Future Potential of Diffusion Tensor Imaging in Traumatic Brain Injury.

    Science.gov (United States)

    Strauss, Sara; Hulkower, Miriam; Gulko, Edwin; Zampolin, Richard L; Gutman, David; Chitkara, Munish; Zughaft, Malka; Lipton, Michael L

    2015-12-01

    In the setting of acute central nervous system (CNS) emergencies, computed tomography (CT) and conventional magnetic resonance imaging (MRI) play an important role in the identification of life-threatening intracranial injury. However, the full extent or even presence of brain damage frequently escapes detection by conventional CT and MRI. Advanced MRI techniques such as diffusion tensor imaging (DTI) are emerging as important adjuncts in the diagnosis of microstructural white matter injury in the acute and postacute brain-injured patient. Although DTI aids in detection of brain injury pathology, which has been repeatedly associated with typical adverse clinical outcomes, the evolution of acute changes and their long-term prognostic implications are less clear and the subject of much active research. A major aim of current research is to identify imaging-based biomarkers that can identify the subset of TBI patients who are at risk for adverse outcome and can therefore most benefit from ongoing care and rehabilitation as well as future therapeutic interventions.The aim of this study is to introduce the current methods used to obtain DTI in the clinical setting, describe a set of common interpretation strategies with their associated advantages and pitfalls, as well as illustrate the clinical utility of DTI through a set of specific patient scenarios. We conclude with a discussion of future potential for the management of TBI.

  8. Inconsistent detection of changes in cerebral blood volume by near infrared spectroscopy in standard clinical tests.

    Science.gov (United States)

    Canova, D; Roatta, S; Bosone, D; Micieli, G

    2011-06-01

    The attractive possibility of near infrared spectroscopy (NIRS) to noninvasively assess cerebral blood volume and oxygenation is challenged by the possible interference from extracranial tissues. However, to what extent this may affect cerebral NIRS monitoring during standard clinical tests is ignored. To address this issue, 29 healthy subjects underwent a randomized sequence of three maneuvers that differently affect intra- and extracranial circulation: Valsalva maneuver (VM), hyperventilation (HV), and head-up tilt (HUT). Putative intracranial ("i") and extracranial ("e") NIRS signals were collected from the forehead and from the cheek, respectively, and acquired together with cutaneous plethysmography at the forehead (PPG), cerebral blood velocity from the middle cerebral artery, and arterial blood pressure. Extracranial contribution to cerebral NIRS monitoring was investigated by comparing Beer-Lambert (BL) and spatially resolved spectroscopy (SRS) blood volume indicators [the total hemoglobin concentration (tHb) and the total hemoglobin index, (THI)] and by correlating their changes with changes in extracranial circulation. While THIe and tHbe generally provided concordant indications, tHbi and THIi exhibited opposite-sign changes in a high percentage of cases (VM: 46%; HV: 31%; HUT: 40%). Moreover, tHbi was correlated with THIi only during HV (P < 0.05), not during VM and HUT, while it correlated with PPG in all three maneuvers (P < 0.01). These results evidence that extracranial circulation may markedly affect BL parameters in a high percentage of cases, even during standard clinical tests. Surface plethysmography at the forehead is suggested as complementary monitoring helpful in the interpretation of cerebral NIRS parameters.

  9. A national survey of Rett syndrome: age, clinical characteristics, current abilities, and health.

    Science.gov (United States)

    Cianfaglione, Rina; Clarke, Angus; Kerr, Mike; Hastings, Richard P; Oliver, Chris; Felce, David

    2015-07-01

    As part of a wider study to investigate the behavioral phenotype of a national sample of girls and women with Rett syndrome (RTT) in comparison to a well-chosen contrast group and its relationship to parental well-being, the development, clinical severity, current abilities and health of 91 participants were analyzed in relation to diagnostic, clinical and genetic mutation categories. Early truncating mutations or large deletions were associated with greater severity. Early regression was also associated with greater severity. All three were associated with lower current abilities. Epilepsy and weight, gastrointestinal and bowel problems were common co-morbidities. Participants with classic RTT had greater health problems than those with atypical RTT. A substantial minority of respondents reported fairly frequent signs of possible pain experienced by their relative with RTT. Overall, the study provides new data on the current abilities and general health of people with RTT and adds to the evidence that the severity of the condition and variation of subsequent disability, albeit generally within the profound range, may be related to gene mutation. The presence of certain co-morbidities represents a substantial ongoing need for better health. The experience of pain requires further investigation.

  10. Antimicrobial Potential of Momordica charantia L. against Multiresistant Standard Species and Clinical Isolates.

    Science.gov (United States)

    Lucena Filho, José Hardman Sátiro de; Lima, Rennaly de Freitas; Medeiros, Ana Claudia Dantas de; Pereira, Jozinete Vieira; Granville-Garcia, Ana Flávia; Costa, Edja Maria Melo de Brito

    2015-11-01

    The aim of the present study was to evaluate the antibacterial and antifungal potential in vitro of Momordica charantia L. against the microorganisms of clinical interest (standard strains and multiresistant isolates) in order to aggregate scientific information in relation to its use as a therapeutic product. M. charantia L. plant material was acquired in municipality of Malta, Paraiba, Brazil. The extract was obtained through maceration, filtration and then concentrated under reduced pressure in a rotary evaporator, resulting in a dough, and was then dried in an oven for 72 hours at 40°C. Antimicrobial action of ethanolic extract of seed M. charantia L. was evaluated based on the minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC) and minimum fungicidal concentration (MFC) against standard strains of bacteria, isolates multiresistant bacteria and Candida species, by microdilution in broth method. All organisms were sensitive to the extract, being considered strong antimicrobial activity (MIC and MBC/MFC < 0.125 mg/ml). The M. charantia L. showed strong antimicrobial potential, with bactericidal and fungicidal profile, there is the prospect to constitute a new therapeutic strategy for the control of infections, particularly in multiresistant strains. The use of medicinal plants in treatment of infectious processes have an important function nowadays, due to the limitations of the use of synthetic antibiotics available, related specifically to the microbial resistance emergence.

  11. Comparison study of judged clinical skills competence from standard setting ratings generated under different administration conditions.

    Science.gov (United States)

    Roberts, William L; Boulet, John; Sandella, Jeanne

    2017-02-21

    When the safety of the public is at stake, it is particularly relevant for licensing and credentialing exam agencies to use defensible standard setting methods to categorize candidates into competence categories (e.g., pass/fail). The aim of this study was to gather evidence to support change to the Comprehensive Osteopathic Medical Licensing-USA Level 2-Performance Evaluation standard setting design and administrative process. Twenty-two video recordings of candidates assessed for clinical competence were randomly selected from the 2014-2015 Humanistic domain test score distribution ranging from the highest to lowest quintile of performance. Nineteen panelists convened at the same site to receive training and practice prior to generating judgments of qualified or not qualified performance to each of the twenty videos. At the end of training, one panel remained onsite to complete their judgments and the second panel was released and given 1 week to observe the same twenty videos and complete their judgments offsite. The two one-sided test procedure established equivalence between panel group means at the 0.05 confidence level, controlling for rater errors within each panel group. From a practical cost-effective and administrative resource perspective, results from this study suggest it is possible to diverge from typical panel groups, who are sequestered the entire time onsite, to larger numbers of panelists who can make their judgments offsite with little impact on judged samples of qualified performance. Standard setting designs having panelists train together and then allowing those to provide judgments yields equivalent ratings and, ultimately, similar cut scores.

  12. Transitional care in clinical networks for young people with juvenile idiopathic arthritis: current situation and challenges.

    Science.gov (United States)

    Cruikshank, Mary; Foster, Helen E; Stewart, Jane; Davidson, Joyce E; Rapley, Tim

    2016-04-01

    Clinical networks for paediatric and adolescent rheumatology are evolving, and their effect and role in the transition process between paediatric and adult services are unknown. We therefore explored the experiences of those involved to try and understand this further. Health professionals, young people with juvenile idiopathic arthritis and their families were recruited via five national health service paediatric and adolescent rheumatology specialist centres and networks across the UK. Seventy participants took part in focus groups and one-to-one interviews. Data was analysed using coding, memoing and mapping techniques to identify features of transitional services across the sector. Variation and inequities in transitional care exist. Although transition services in networks are evolving, development has lagged behind other areas with network establishment focusing more on access to paediatric rheumatology multidisciplinary teams. Challenges include workforce shortfalls, differences in service priorities, standards and healthcare infrastructures, and managing the legacy of historic encounters. Providing equitable high-quality clinically effective services for transition across the UK has a long way to go. There is a call from within the sector for more protected time, staff and resources to develop transition roles and services, as well as streamlining of local referral pathways between paediatric and adult healthcare services. In addition, there is a need to support professionals in developing their understanding of transitional care in clinical networks, particularly around service design, organisational change and the interpersonal skills required for collaborative working. Key messages • Transitional care in clinical networks requires collaborative working and an effective interface with paediatric and adult rheumatology.• Professional centrism and historic encounters may affect collaborative relationships within clinical networks.• Education

  13. Efficacy of standard vs. extended intramammary cefquinome treatment of clinical mastitis in cows with persistent high somatic cell counts

    NARCIS (Netherlands)

    Swinkels, Jantijn M.; Krömker, Volker; Lam, Theo J G M

    2014-01-01

    Extended duration of clinical mastitis (CM) treatment has been advocated, although results showing its higher efficacy compared with standard treatment are difficult to compare and seem conflicting. In a non-blinded, positively controlled clinical trial with systematic allocation, the efficacy of a

  14. Standard Setting for Clinical Competence at Graduation from Medical School: A Comparison of Passing Scores across Five Medical Schools

    Science.gov (United States)

    Boursicot, Katharine A. M.; Roberts, Trudie E.; Pell, Godfrey

    2006-01-01

    While Objective Structured Clinical Examinations (OSCEs) have become widely used to assess clinical competence at the end of undergraduate medical courses, the method of setting the passing score varies greatly, and there is no agreed best methodology. While there is an assumption that the passing standard at graduation is the same at all medical…

  15. First clinical use of a standardized three-dimensional ultrasound for breast imaging

    Energy Technology Data Exchange (ETDEWEB)

    Kotsianos-Hermle, D. [Department of Clinical Radiology, University of Munich (Germany)], E-mail: dorothea.hermle@med.uni-muenchen.de; Wirth, S.; Fischer, T. [Department of Clinical Radiology, University of Munich (Germany); Hiltawsky, K.M. [General Electric, Global Research, Garching (Germany); Reiser, M. [Department of Clinical Radiology, University of Munich (Germany)

    2009-07-15

    Objectives: The feasibility, image quality, and diagnostic potential of the prototype of an automated ultrasound (US) breast scanner were examined. Methods: Ninety-seven patients with suspicious breast lesions had mammograms, manual US, and an automated breast US. The data were evaluated according to the breast imaging reporting and data system (BIRADS) classification, image quality, and amount to diagnostic information. All lesions were confirmed histological. Results: The image quality of the three-dimensional (3D) data sets was equal to or satisfactory compared with cross-sectional images from manual US in at least 72% of cases (p < 0.05). The diagnostic information was equal or superior in at least 63% of cases (p < 0.05). Conclusions: Standardized 3D US scanning is a promising diagnostic adjunct to mammography, but is no substitute for manual US at the current stage of development.

  16. Clinical Risk Assessment in the Antiphospholipid Syndrome: Current Landscape and Emerging Biomarkers.

    Science.gov (United States)

    Chaturvedi, Shruti; McCrae, Keith R

    2017-07-01

    Laboratory criteria for the classification of antiphospholipid syndrome include the detection of a lupus anticoagulant and/or anticardiolipin and anti-β2-glycoprotein I antibodies. However, the majority of patients who test positive in these assays do not have thrombosis. Current risk-stratification tools are largely limited to the antiphospholipid antibody profile and traditional thrombotic risk factors. Novel biomarkers that correlate with disease activity and potentially provide insight into future clinical events include domain 1 specific anti-β2GPI antibodies, antibodies to other phospholipids or phospholipid/protein antigens (such as anti-PS/PT), and functional/biological assays such as thrombin generation, complement activation, levels of circulating microparticles, and annexin A5 resistance. Clinical risk scores may also have value in predicting clinical events. Biomarkers that predict thrombosis risk in patients with antiphospholipid antibodies have been long sought, and several biomarkers have been proposed. Ultimately, integration of biomarkers with established assays and clinical characteristics may offer the best chance of identifying patients at highest risk of APS-related complications.

  17. Omics-based biomarkers: current status and potential use in the clinic

    Directory of Open Access Journals (Sweden)

    Héctor Quezada

    2017-05-01

    Full Text Available In recent years, the use of high-throughput omics technologies has led to the rapid discovery of many candidate biomarkers. However, few of them have made the transition to the clinic. In this review, the promise of omics technologies to contribute to the process of biomarker development is described. An overview of the current state in this area is presented with examples of genomics, proteomics, transcriptomics, metabolomics and microbiomics biomarkers in the field of oncology, along with some proposed strategies to accelerate their validation and translation to improve the care of patients with neoplasms. The inherent complexity underlying neoplasms combined with the requirement of developing well-designed biomarker discovery processes based on omics technologies present a challenge for the effective development of biomarkers that may be useful in guiding therapies, addressing disease risks, and predicting clinical outcomes.

  18. Navigating the current landscape of clinical genetic testing for inherited retinal dystrophies.

    Science.gov (United States)

    Lee, Kristy; Garg, Seema

    2015-04-01

    Inherited eye disorders are a significant cause of vision loss. Genetic testing can be particularly helpful for patients with inherited retinal dystrophies because of genetic heterogeneity and overlapping phenotypes. The need to identify a molecular diagnosis for retinal dystrophies is particularly important in the era of developing novel gene therapy-based treatments, such as the RPE65 gene-based clinical trials and others on the horizon, as well as recent advances in reproductive options. The introduction of massively parallel sequencing technologies has significantly advanced the identification of novel gene candidates and has expanded the landscape of genetic testing. In a relatively short time clinical medicine has progressed from limited testing options to a plethora of choices ranging from single-gene testing to whole-exome sequencing. This article outlines currently available genetic testing and factors to consider when selecting appropriate testing for patients with inherited retinal dystrophies.

  19. Utilization study of antidiabetic agents in a teaching hospital of Sikkim and adherence to current standard treatment guidelines

    Directory of Open Access Journals (Sweden)

    Sushrut Varun Satpathy

    2016-01-01

    Full Text Available Objective: Diabetes has gradually emerged as one of the most serious public health problems in our country. This underlines the need for timely disease detection and decisive therapeutic intervention. This prospective cross-sectional observational study aims at analyzing the utilization pattern of antidiabetic agents in a remote North-East Indian tertiary care teaching hospital in the perspective of current standard treatment guidelines. Materials and Methods: Diabetic patients receiving antidiabetic medication, both as outpatients and inpatients in our hospital over a period of 12 months (May 2013–May 2014, were included in this study. The data obtained were sorted and analyzed on the basis of gender, type of therapy, and hospital setting. Results: A total of 310 patients were included in the study. Metformin was the single most frequently prescribed antidiabetic agent (66.8% followed by the sulfonylureas group (37.4%. Insulin was prescribed in 23.2% of the patients. Combination antidiabetic drug therapy (65.1% was used more frequently than monotherapy (34.8%. The use of biguanides (P < 0.0001 and sulfonylureas (P = 0.02 in combination was significant as compared to their use as monotherapy. A total of 48% of all antidiabetic combinations used, comprised metformin and sulfonylureas (n = 96. Insulin use was significantly higher as monotherapy and in inpatients (P< 0.0001. The utilization of drugs from the National List of Essential Medicines was 51.2%, while 11% of antidiabetics were prescribed by generic name. Conclusion: The pattern of utilization largely conforms to the current standard treatment guidelines. Increased use of generic drugs is an area with scope for improvement.

  20. Immunotherapy and therapeutic vaccines in prostate cancer:an update on current strategies and clinical implications

    Institute of Scientific and Technical Information of China (English)

    B Harpreet Singh; James L Gulley

    2014-01-01

    In recent years, immunotherapy has emerged as a viable and attractive strategy for the treatment of prostate cancer. While there are multiple ways to target the immune system, therapeutic cancer vaccines and immune checkpoint inhibitors have been most successful in late-stage clinical trials. The landmark Food and Drug Administration approval of sipuleucel-T for asymptomatic or minimally symptomatic metastatic prostate cancer set the stage for ongoing phase III trials with the cancer vaccine PSA-TRICOM and the immune checkpoint inhibitor ipilimumab. A common feature of these immune-based therapies is the appearance of improved overall survival without short-term changes in disease progression. This class effect appears to be due to modulation of tumor growth rate kinetics, in which the activated immune system exerts constant immunologic pressure that slows net tumor growth. Emerging data suggest that the ideal population for clinical trials of cancer vaccines is patients with lower tumor volume and less aggressive disease. Combination strategies that combine immunotherapy with standard therapies have been shown to augment both immune response and clinical beneift.

  1. Drug development and nonclinical to clinical translational databases: past and current efforts.

    Science.gov (United States)

    Monticello, Thomas M

    2015-01-01

    The International Consortium for Innovation and Quality (IQ) in Pharmaceutical Development is a science-focused organization of pharmaceutical and biotechnology companies. The mission of the Preclinical Safety Leadership Group (DruSafe) of the IQ is to advance science-based standards for nonclinical development of pharmaceutical products and to promote high-quality and effective nonclinical safety testing that can enable human risk assessment. DruSafe is creating an industry-wide database to determine the accuracy with which the interpretation of nonclinical safety assessments in animal models correctly predicts human risk in the early clinical development of biopharmaceuticals. This initiative aligns with the 2011 Food and Drug Administration strategic plan to advance regulatory science and modernize toxicology to enhance product safety. Although similar in concept to the initial industry-wide concordance data set conducted by International Life Sciences Institute's Health and Environmental Sciences Institute (HESI/ILSI), the DruSafe database will proactively track concordance, include exposure data and large and small molecules, and will continue to expand with longer duration nonclinical and clinical study comparisons. The output from this work will help identify actual human and animal adverse event data to define both the reliability and the potential limitations of nonclinical data and testing paradigms in predicting human safety in phase 1 clinical trials. © 2014 by The Author(s).

  2. Immunotherapy and therapeutic vaccines in prostate cancer: an update on current strategies and clinical implications

    Directory of Open Access Journals (Sweden)

    B Harpreet Singh

    2014-06-01

    Full Text Available In recent years, immunotherapy has emerged as a viable and attractive strategy for the treatment of prostate cancer. While there are multiple ways to target the immune system, therapeutic cancer vaccines and immune checkpoint inhibitors have been most successful in late-stage clinical trials. The landmark Food and Drug Administration approval of sipuleucel-T for asymptomatic or minimally symptomatic metastatic prostate cancer set the stage for ongoing phase III trials with the cancer vaccine PSA-TRICOM and the immune checkpoint inhibitor ipilimumab. A common feature of these immune-based therapies is the appearance of improved overall survival without short-term changes in disease progression. This class effect appears to be due to modulation of tumor growth rate kinetics, in which the activated immune system exerts constant immunologic pressure that slows net tumor growth. Emerging data suggest that the ideal population for clinical trials of cancer vaccines is patients with lower tumor volume and less aggressive disease. Combination strategies that combine immunotherapy with standard therapies have been shown to augment both immune response and clinical benefit.

  3. Dry age-related macular degeneration: A currently unmet clinical need.

    Science.gov (United States)

    Girmens, Jean-François; Sahel, José-Alain; Marazova, Katia

    2012-08-01

    Age-related macular degeneration (AMD) is a leading cause of severe visual impairment and disability in older people worldwide. Although considerable advances in the management of the neovascular form of AMD have been made in the last decade, no therapy is yet available for the advanced dry form of AMD (geographic atrophy). This review focuses on current trends in the development of new therapies targeting specific pathophysiological pathways of dry AMD. Increased understanding of the complex mechanisms that underlie dry AMD will help to address this largely unmet clinical need.

  4. A review of the current state of digital plate reading of cultures in clinical microbiology.

    Science.gov (United States)

    Rhoads, Daniel D; Novak, Susan M; Pantanowitz, Liron

    2015-01-01

    Digital plate reading (DPR) is increasingly being adopted as a means to facilitate the analysis and improve the quality and efficiency within the clinical microbiology laboratory. This review discusses the role of DPR in the context of total laboratory automation and explores some of the platforms currently available or in development for digital image capturing of microbial growth on media. The review focuses on the advantages and challenges of DPR. Peer-reviewed studies describing the utility and quality of these novel DPR systems are largely lacking, and professional guidelines for DPR implementation and quality management are needed. Further development and more widespread adoption of DPR is anticipated.

  5. [Current status of bone/cartilage tissue engineering towards clinical applications].

    Science.gov (United States)

    Ohgushi, Hajime

    2014-10-01

    Osteo/chondrogenic differentiation capabilities are seen after in vivo implantation of mesenchymal stem cells (MSCs), which are currently used for the patients having bone/cartilage defects. Importantly, the differentiation capabilities are induced by culturing technology, resulting in in vitro bone/cartilage formation. Especially, the in vitro bone tissue is useful for bone tissue regeneration. For cartilage regeneration, culture expanded chondrocytes derived from patient's normal cartilage are also used for the patients having cartilage damages. Recently, the cultured chondrocytes embedded in atelocollagen gel are obtainable as tissue engineered products distributed by Japan Tissue Engineering Co. Ltd. The products are available in the well-regulated hospitals by qualified orthopedic surgeons. The criteria for these hospitals/surgeons have been established. This review paper focuses on current status of bone/cartilage tissue engineering towards clinical applications in Japan.

  6. PDE-5 Inhibitors in Scleroderma Raynaud Phenomenon and Digital Ulcers: Current Status of Clinical Trials

    Directory of Open Access Journals (Sweden)

    Ann J. Impens

    2011-01-01

    Full Text Available Systemic sclerosis- (SSc- related vasculopathy, as manifested by Raynaud's Phenomenon (RP and digital ulcers (DUs, is associated with significant impairment of the quality of life and morbidity. The current vasoactive approach for SSc-RP, although employing vasodilators, is entirely off-label. PDE-5 inhibitors improve peripheral circulation, are well tolerated, and are widely used for various forms of constrictive vasculopathies. This class of medications has become one of the first lines of treatment of SSc-RP and SSc-DUs among rheumatologists that routinely treat SSc patients. Due to the lack of robust randomized clinical trials of PDE-5 inhibitors in SSc-RP/DUs, the PDE-5 inhibitors have not been FDA approved for these particular indications, which constitutes a significant barrier to prescribing this category of drugs. This paper reviews the current state of evidence-based knowledge in SSc-related vasculopathy and the use of PDE-5 inhibitors.

  7. [Standards, options and recommendations: Good clinical practice in the dietetic management of cancer patients: hospital catering].

    Science.gov (United States)

    Dayot, F; Bataillard, A; Keré, C; Ducès, F; Bachmann, P; Blanc-Vincent, M P; Besnard, B; Bonneteau, C; Champetier, S; Claude, M; Combret, D; Cometto, F; Duguet, A; Duval, N; Finck, C; Freby-Lehner, A; Garabige, V; Lallemand, Y; Massoud, C; Meuric, J; Montane, C; Poirée, B; Puel, S; Rossignol, G; Roux-Bournay, P; Simon, M; Tran, M

    2001-10-01

    The "Standards, Options and Recommendations" (SOR) project, started in 1993, involves a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Regional Cancer Centres, some French public university and general hospitals and private Clinics and medical scientific societies. Its main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on a literature review followed by a critical appraisal by a multidisciplinary group of experts to produce the draft guidelines which are then validated by specialists in cancer care delivery. To develop clinical practice guidelines for hospital catering for cancer patient using the methodology developed by the Standards, Options and Recommendations project. Data were identified by a literature search of Medline and the reference lists of experts in the groups. After the guidelines were drafted, they were validated by independent reviewers. The main recommendations are: 1) While taking into consideration the specific needs of cancer patients, the dietician is responsible for the hygiene, the sanitary quality of alimentation, the equilibrium and nutritional quality of the hospital catering. 2) Ordering and distribution of meals, and clearing up afterwards contribute to the quality of hospital catering and the personnel who do this should have time and be willing to listen to the patients. 3) The ordering of meals should be adapted to individual patient's requirements and must take into account the patient's medication. 4) The method of transporting the food chosen by the institution (cold or warm method) should be respected. The personnel responsible should receive regular and specific training to use the method correctly. 5) The intake of patients with nutritional follow-up should be reliably and reproducibly evaluated by the personnel after every meal. 6) Patient satisfaction should be assessed

  8. Nonlinear speech analysis algorithms mapped to a standard metric achieve clinically useful quantification of average Parkinson's disease symptom severity

    OpenAIRE

    Tsanas, Athanasios; Little, Max A.; McSharry, Patrick E; Ramig, Lorraine O.

    2011-01-01

    The standard reference clinical score quantifying average Parkinson's disease (PD) symptom severity is the Unified Parkinson's Disease Rating Scale (UPDRS). At present, UPDRS is determined by the subjective clinical evaluation of the patient's ability to adequately cope with a range of tasks. In this study, we extend recent findings that UPDRS can be objectively assessed to clinically useful accuracy using simple, self-administered speech tests, without requiring the patient's physical presen...

  9. Nonlinear speech analysis algorithms mapped to a standard metric achieve clinically useful quantification of average Parkinson's disease symptom severity

    OpenAIRE

    Tsanas, Athanasios; Little, Max A.; McSharry, Patrick E; Ramig, Lorraine O.

    2010-01-01

    The standard reference clinical score quantifying average Parkinson's disease (PD) symptom severity is the Unified Parkinson's Disease Rating Scale (UPDRS). At present, UPDRS is determined by the subjective clinical evaluation of the patient's ability to adequately cope with a range of tasks. In this study, we extend recent findings that UPDRS can be objectively assessed to clinically useful accuracy using simple, self-administered speech tests, without requiring the patient's physical presen...

  10. The clinical endocrinology workforce: current status and future projections of supply and demand.

    Science.gov (United States)

    Vigersky, Robert A; Fish, Lisa; Hogan, Paul; Stewart, Andrew; Kutler, Stephanie; Ladenson, Paul W; McDermott, Michael; Hupart, Kenneth H

    2014-09-01

    Many changes in health care delivery, health legislation, and the physician workforce that affect the supply and demand for endocrinology services have occurred since the first published workforce study of adult endocrinologists in 2003. The objective of the study was to assess the current adult endocrinology workforce data and provide the first analysis of the pediatric endocrinology workforce and to project the supply of and demand for endocrinologists through 2025. A workforce model was developed from an analysis of proprietary and publicly available databases, consultation with a technical expert panel, and the results of an online survey of board-certified endocrinologists. The Endocrine Society commissioned The Lewin Group to estimate current supply and to project gaps between supply and demand for endocrinologists. A technical expert panel of senior endocrinologists provided context, clinical information, and direction. The following were measured: 1) the current adult and pediatric endocrinology workforce and the supply of and demand for endocrinologists through 2025 and 2) the number of additional entrants into the endocrinology work pool that would be required to close the gap between supply and demand. Currently there is a shortage of approximately 1500 adult and 100 pediatric full-time equivalent endocrinologists. The gap for adult endocrinologists will expand to 2700 without an increase in the number of fellows trained. An increase in the prevalence of diabetes mellitus further expands the demand for adult endocrinologists. The gap can be closed in 5 and 10 years by increasing the number of fellowship positions by 14.4% and 5.5% per year, respectively. The gap between supply and demand for pediatric endocrinologists will close by 2016, and thereafter an excess supply over demand will develop at the current rate of new entrants into the work force. There are insufficient adult endocrinologists to satisfy current and future demand. A number of proactive

  11. MO-D-213-08: Remote Dosimetric Credentialing for Clinical Trials with the Virtual EPID Standard Phantom Audit (VESPA)

    Energy Technology Data Exchange (ETDEWEB)

    Lehmann, J [Calvary Mater Newcastle, Newcastle, NSW (Australia); University of Sydney, Sydney, NSW (Australia); Miri, N [University of Newcastle, Newcastle, NSW (Australia); Vial, P [Liverpool Hospital, Liverpool, NSW (Australia); Hatton, J [Trans Tasman Radiation Oncology Group (TROG), Newcastle, NSW (Australia); Zwan, B; Sloan, K [Gosford Hospital, Gosford, NSW (Australia); Craig, A; Beenstock, V [Canterbury Regional Cancer and Haematology Service, Christchurch (New Zealand); Molloy, T [Orange Hospital, Orange, NSW (Australia); Greer, P [Calvary Mater Newcastle, Newcastle, NSW (Australia); University of Newcastle, Newcastle, NSW (Australia)

    2015-06-15

    Purpose: Report on implementation of a Virtual EPID Standard Phantom Audit (VESPA) for IMRT to support credentialing of facilities for clinical trials. Data is acquired by local facility staff and transferred electronically. Analysis is performed centrally. Methods: VESPA is based on published methods and a clinically established IMRT QA procedure, here extended to multi-vendor equipment. Facilities, provided with web-based comprehensive instructions and CT datasets, create IMRT treatment plans. They deliver the treatments directly to their EPID without phantom or couch in the beam. They also deliver a set of simple calibration fields. Collected EPID images are uploaded electronically. In the analysis, the dose is projected back into a virtual phantom and 3D gamma analysis is performed. 2D dose planes and linear dose profiles can be analysed when needed for clarification. Results: Pilot facilities covering a range of planning and delivery systems have performed data acquisition and upload successfully. Analysis showed agreement comparable to local experience with the method. Advantages of VESPA are (1) fast turnaround mainly driven by the facility’s capability to provide the requested EPID images, (2) the possibility for facilities performing the audit in parallel, as there is no need to wait for a phantom, (3) simple and efficient credentialing for international facilities, (4) a large set of data points, and (5) a reduced impact on resources and environment as there is no need to transport heavy phantoms or audit staff. Limitations of the current implementation of VESPA for trials credentialing are that it does not provide absolute dosimetry, therefore a Level 1 audit still required, and that it relies on correctly delivered open calibration fields, which are used for system calibration. Conclusion: The implemented EPID based IMRT audit system promises to dramatically improve credentialing efficiency for clinical trials and wider applications. VESPA for VMAT

  12. “Heidelberg standard examination” and “Heidelberg standard procedures” – Development of faculty-wide standards for physical examination techniques and clinical procedures in undergraduate medical education

    Directory of Open Access Journals (Sweden)

    Nikendei, C.

    2016-08-01

    Full Text Available The competent physical examination of patients and the safe and professional implementation of clinical procedures constitute essential components of medical practice in nearly all areas of medicine. The central objective of the projects “Heidelberg standard examination” and “Heidelberg standard procedures”, which were initiated by students, was to establish uniform interdisciplinary standards for physical examination and clinical procedures, and to distribute them in coordination with all clinical disciplines at the Heidelberg University Hospital. The presented project report illuminates the background of the initiative and its methodological implementation. Moreover, it describes the multimedia documentation in the form of pocketbooks and a multimedia internet-based platform, as well as the integration into the curriculum. The project presentation aims to provide orientation and action guidelines to facilitate similar processes in other faculties.

  13. Whole Body Vibration Exercise Protocol versus a Standard Exercise Protocol after ACL Reconstruction: A Clinical Randomized Controlled Trial with Short Term Follow-Up

    Directory of Open Access Journals (Sweden)

    Gereon Berschin

    2014-09-01

    Full Text Available The suitability and effectiveness of whole body vibration (WBV exercise in rehabilitation after injury of the anterior cruciate ligament (ACL was studied using a specially designed WBV protocol. We wanted to test the hypothesis if WBV leads to superior short term results regarding neuromuscular performance (strength and coordination and would be less time consuming than a current standard muscle strengthening protocol. In this prospective randomized controlled clinical trial, forty patients who tore their ACL and underwent subsequent ligament reconstruction were enrolled. Patients were randomized to the whole body vibration (n=20 or standard rehabilitation exercise protocol (n=20. Both protocols started in the 2nd week after surgery. Isometric and isokinetic strength measurements, clinical assessment, Lysholm score, neuromuscular performance were conducted weeks 2, 5, 8 and 11 after surgery. Time spent for rehabilitation exercise was reduced to less than a half in the WBV group. There were no statistically significant differences in terms of clinical assessment, Lysholm score, isokinetic and isometric strength. The WBV group displayed significant better results in the stability test. In conclusion, preliminary data indicate that our whole body vibration muscle exercise protocol seems to be a good alternative to a standard exercise program in ACL-rehabilitation. Despite of its significant reduced time requirement it is at least equally effective compared to a standard rehabilitation protocol.

  14. Mind-body CAM interventions: current status and considerations for integration into clinical health psychology.

    Science.gov (United States)

    Park, Crystal

    2013-01-01

    Complementary and alternative medicine (CAM) is increasingly used for treating myriad health conditions and for maintaining general health. The present article provides an overview of current CAM use with a specific focus on mind-body CAM and its efficacy in treating health conditions. Characteristics of CAM users are presented, and then evidence regarding the efficacy of mind-body treatments (biofeedback, meditation, guided imagery, progressive muscle relaxation, deep breathing, hypnosis, yoga, tai chi, and qi gong) is reviewed. Demographics associated with CAM use are fairly well-established, but less is known about their psychological characteristics. Although the efficacy of mind-body CAM modalities for health conditions is receiving a great deal of research attention, studies have thus far produced a weak base of evidence. Methodological limitations of current research are reviewed. Suggestions are made for future research that will provide more conclusive knowledge regarding efficacy and, ultimately, effectiveness of mind-body CAM. Considerations for clinical applications, including training and competence, ethics, treatment tailoring, prevention efforts, and diversity, conclude the article. Integration of CAM modalities into clinical health psychology can be useful for researchers taking a broader perspective on stress and coping processes, illness behaviors, and culture; for practitioners seeking to incorporate CAM perspectives into their work; and for policy makers in directing healthcare resources wisely. © 2012 Wiley Periodicals, Inc.

  15. The Immunology of Neuromyelitis Optica—Current Knowledge, Clinical Implications, Controversies and Future Perspectives

    Science.gov (United States)

    Jasiak-Zatonska, Michalina; Kalinowska-Lyszczarz, Alicja; Michalak, Slawomir; Kozubski, Wojciech

    2016-01-01

    Neuromyelitis optica (NMO) is an autoimmune, demyelinating disorder of the central nervous system (CNS) with typical clinical manifestations of optic neuritis and acute transverse myelitis attacks. Previously believed to be a variant of multiple sclerosis (MS), it is now considered an independent disorder which needs to be differentiated from MS. The discovery of autoantibodies against aquaporin-4 (AQP4-IgGs) changed our understanding of NMO immunopathogenesis and revolutionized the diagnostic process. AQP4-IgG is currently regarded as a specific biomarker of NMO and NMO spectrum disorders (NMOsd) and a key factor in its pathogenesis. Nevertheless, AQP4-IgG seronegativity in 10%–25% of NMO patients suggests that there are several other factors involved in NMO immunopathogenesis, i.e., autoantibodies against aquaporin-1 (AQP1-Abs) and antibodies against myelin oligodendrocyte glycoprotein (MOG-IgGs). This manuscript reviews current knowledge about NMO immunopathogenesis, pointing out the controversial issues and showing potential directions for future research. Further efforts should be made to broaden our knowledge of NMO immunology which could have important implications for clinical practice, including the use of potential novel biomarkers to facilitate an early and accurate diagnosis, and modern treatment strategies improving long-term outcome of NMO patients. PMID:26950113

  16. The Immunology of Neuromyelitis Optica-Current Knowledge, Clinical Implications, Controversies and Future Perspectives.

    Science.gov (United States)

    Jasiak-Zatonska, Michalina; Kalinowska-Lyszczarz, Alicja; Michalak, Slawomir; Kozubski, Wojciech

    2016-03-02

    Neuromyelitis optica (NMO) is an autoimmune, demyelinating disorder of the central nervous system (CNS) with typical clinical manifestations of optic neuritis and acute transverse myelitis attacks. Previously believed to be a variant of multiple sclerosis (MS), it is now considered an independent disorder which needs to be differentiated from MS. The discovery of autoantibodies against aquaporin-4 (AQP4-IgGs) changed our understanding of NMO immunopathogenesis and revolutionized the diagnostic process. AQP4-IgG is currently regarded as a specific biomarker of NMO and NMO spectrum disorders (NMOsd) and a key factor in its pathogenesis. Nevertheless, AQP4-IgG seronegativity in 10%-25% of NMO patients suggests that there are several other factors involved in NMO immunopathogenesis, i.e., autoantibodies against aquaporin-1 (AQP1-Abs) and antibodies against myelin oligodendrocyte glycoprotein (MOG-IgGs). This manuscript reviews current knowledge about NMO immunopathogenesis, pointing out the controversial issues and showing potential directions for future research. Further efforts should be made to broaden our knowledge of NMO immunology which could have important implications for clinical practice, including the use of potential novel biomarkers to facilitate an early and accurate diagnosis, and modern treatment strategies improving long-term outcome of NMO patients.

  17. The Immunology of Neuromyelitis Optica—Current Knowledge, Clinical Implications, Controversies and Future Perspectives

    Directory of Open Access Journals (Sweden)

    Michalina Jasiak-Zatonska

    2016-03-01

    Full Text Available Neuromyelitis optica (NMO is an autoimmune, demyelinating disorder of the central nervous system (CNS with typical clinical manifestations of optic neuritis and acute transverse myelitis attacks. Previously believed to be a variant of multiple sclerosis (MS, it is now considered an independent disorder which needs to be differentiated from MS. The discovery of autoantibodies against aquaporin-4 (AQP4-IgGs changed our understanding of NMO immunopathogenesis and revolutionized the diagnostic process. AQP4-IgG is currently regarded as a specific biomarker of NMO and NMO spectrum disorders (NMOsd and a key factor in its pathogenesis. Nevertheless, AQP4-IgG seronegativity in 10%–25% of NMO patients suggests that there are several other factors involved in NMO immunopathogenesis, i.e., autoantibodies against aquaporin-1 (AQP1-Abs and antibodies against myelin oligodendrocyte glycoprotein (MOG-IgGs. This manuscript reviews current knowledge about NMO immunopathogenesis, pointing out the controversial issues and showing potential directions for future research. Further efforts should be made to broaden our knowledge of NMO immunology which could have important implications for clinical practice, including the use of potential novel biomarkers to facilitate an early and accurate diagnosis, and modern treatment strategies improving long-term outcome of NMO patients.

  18. Standardized patients in audiology: a proposal for a new method of evaluating clinical competence.

    Science.gov (United States)

    Dinsmore, Brooke Freeman; Bohnert, Carrie; Preminger, Jill E

    2013-05-01

    While accrediting organizations require AuD programs to provide evidence that their students are able to demonstrate knowledge and competencies in specific content areas, there are no generally accepted mechanisms for the assessment and the measurement of these proficiencies. We propose that AuD programs consider developing standardized patient (SP) cases in order to develop consistent summative assessment programs within and across universities. The purpose of this article is to provide a framework for establishing SP programs to evaluate competencies in AuD students by detailing the history of SP cases and their use, developing a rationale for this method of assessment, and outlining the steps for writing and implementing SP cases. Literature review. SPs have been used to assess clinical competence in medical students for over 50 yr. The prevalence of SP assessment in allied health professions (e.g., dentistry, psychology, pharmacy) has increased over the last two decades but has only gained a limited following in audiology. SP assessment has been implemented in medical education using the Objective Structured Clinical Examination, a multistation, timed exam that uses fictional cases to assess students' clinical abilities. To date, only one published report has been completed that evaluates the use of SPs to assess clinical abilities in audiology students. This article expands upon the work of English et al (2007) and their efforts to use SPs to evaluate counseling abilities. To this end, we describe the steps necessary to write a case, procedures to determine performance requirements, and the need to develop remediation plans. As an example, we include a case that we have developed in order to evaluate vestibular assessment and patient communication skills. Utilizing SP assessment in audiology education would provide useful means to evaluate competence in a uniform way. Future research is necessary to develop reliable and valid cases that may be implemented

  19. [History, current state and future perspective of tuberculosis research and clinical medicine].

    Science.gov (United States)

    Ito, Yutaka; Mishima, Michiaki

    2011-08-01

    Since Robert Koch identified Mycobacterium tuberculosis as causative agent of tuberculosis (TB) in 1882, TB research has developed in various fields, such as bacteriology, immunology, genomic study and genetic susceptibility. These research results have led to the knowledge concerning cellular immunity and the development of biochemical and gene diagnostic approach for M. tuberculosis, interferon-gamma release assay for latent TB infection and epidemiologic study using variable numbers of tandem repeats. After Selman A. Waksman isolated streptomycin, various drugs came to be used. Standard of the TB treatments has been revised several times up to now. Discovery of the novel drugs potential for multidrug-resistant TB is challenged. Close relationships among basic research, clinical medicine and health service are crucial to improving global control of TB.

  20. The placebo response in clinical trials-the current state of play.

    Science.gov (United States)

    Enck, Paul; Klosterhalfen, Sibylle

    2013-04-01

    While randomized, placebo-controlled double-blinded trials have become the pharmacological standard over the last 60 years, the gain in knowledge of the mechanisms behind the placebo response in recent years has raised substantial concerns about the appropriateness of some of its underlying assumptions. The following questions will be addressed: Is the assumed model of drug and placebo being additive (still) valid? Does the likelihood of receiving active treatment affect the placebo response? What is the size of the placebo response in "active comparator studies"? Minimizing the placebo response/maximizing the drug-placebo difference? How to maximize the placebo response in daily medicine? What is the placebo response with personalized medicines in the future? This and other questions require answers that can only be generated with more experimental studies on the placebo response and with thorough meta- and re-analyses of placebo responses in clinical trials.

  1. The association between current unemployment and clinically determined poor oral health.

    Science.gov (United States)

    Al-Sudani, Fouad Y H; Vehkalahti, Miira M; Suominen, Anna L

    2015-08-01

    The aim of this study was to assess whether current unemployment was associated with poor oral health and whether there was a difference in oral health according to the duration of the current unemployment. As part of the Health 2000 Survey in Finland (a nationwide comprehensive health examination survey), we used its data based on interviews, questionnaires, and clinical oral examinations of the 30- to 63-year-old respondents (n = 4773). Current employment status was measured in its dichotomous form, employed versus unemployed, and length of current unemployment was classified into four categories. We measured oral health in terms of numbers of missing teeth, of sound teeth, of filled teeth, of decayed teeth, and of teeth with deepened periodontal pockets (≥4 mm, ≥6 mm). Poisson regression models were fitted for all oral health outcomes except number of decayed teeth, for which negative binomial regression model was used. Oral health-related behaviors and sociodemographic and socioeconomic factors were added to the analyses. The unemployed subjects had higher numbers of missing teeth, of decayed teeth, and of teeth with periodontal pockets than the employed ones. The association remained consistent even after adjustments. Oral health-related behaviors seemed to mediate the association. We found no association between unemployment and number of sound teeth. Current long-term unemployment showed stronger association with poor oral health than short-term among women. The unemployed can be considered as a risk group for poor oral health. Oral healthcare should be reoriented toward those who are unemployed. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  2. [Technical and functional standards and implementation of a clinical information system in intensive care units].

    Science.gov (United States)

    Gómez Tello, V; Alvarez Rodríguez, J; Núñez Reiz, A; González Sánchez, J A; Hernández Abadía de Barbará, A; Martínez Fresneda, M; Morrondo Valdeolmillos, P; Nicolás Arfelis, J M; Pujol Varela, I; Calvete Chicharro, M

    2011-11-01

    Clinical Information Systems (CIS) are becoming a useful tool for managing patients and data in the ICU. However, the existing CIS differ in their capabilities and technical requirements. It is therefore essential for intensivists, as the end clients of these applications, to define the suitable minimum specifications required in order to be operative and helpful. The Spanish Society of Intensive Care Medicine and Coronary Units, through its Organization and Management Workgroup, has designated a group of clinical and software experts to draft a document with the recommendable technical and operating requirements of these systems. The group was formed by ten people supported by managers or engineers from the five principal industries producing CIS in Spain. The project involved the following phases: a) Completion of a check list. This step was considered necessary in order to establish the precise current situation of CIS applications. b) Discussion of the results by the group of experts in a meeting and in online format. The requirements were grouped into four sections: technical, functional, safety and data management. All requirements were classified as basic and optional in order to allow the end user to choose among different options according to the existing budget, though ensuring a minimal set of useful characteristics. A chronogram for the installation process was also proposed. Copyright © 2011 Elsevier España, S.L. y SEMICYUC. All rights reserved.

  3. Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review

    Directory of Open Access Journals (Sweden)

    Patrícia do Carmo Silva Parreira

    2014-03-01

    Full Text Available Questions: Is Kinesio Taping more effective than a sham taping/placebo, no treatment or other interventions in people with musculoskeletal conditions? Is the addition of Kinesio Taping to other interventions more effective than other interventions alone in people with musculoskeletal conditions? Design: Systematic review of randomised trials. Participants: People with musculoskeletal conditions. Intervention: Kinesio Taping was compared with sham taping/placebo, no treatment, exercises, manual therapy and conventional physiotherapy. Outcome measures: Pain intensity, disability, quality of life, return to work, and global impression of recovery. Results: Twelve randomised trials involving 495 participants were included in the review. The effectiveness of the Kinesio Taping was tested in participants with: shoulder pain in two trials; knee pain in three trials; chronic low back pain in two trials; neck pain in three trials; plantar fasciitis in one trial; and multiple musculoskeletal conditions in one trial. The methodological quality of eligible trials was moderate, with a mean of 6.1 points on the 10-point PEDro Scale score. Overall, Kinesio Taping was no better than sham taping/placebo and active comparison groups. In all comparisons where Kinesio Taping was better than an active or a sham control group, the effect sizes were small and probably not clinically significant or the trials were of low quality. Conclusion: This review provides the most updated evidence on the effectiveness of the Kinesio Taping for musculoskeletal conditions. The current evidence does not support the use of this intervention in these clinical populations. PROSPERO registration: CRD42012003436. [Parreira PdCS, Costa LdCM, Hespanhol Junior LC, Lopes AD, Costa LOP (2014 Current evidence does not support the use of Kinesio Taping in clinical practice: a systematic review. Journal of Physiotherapy 60: 31–39

  4. Cutaneous leishmaniasis in Syria: clinical features, current status and the effects of war.

    Science.gov (United States)

    Hayani, Kinan; Dandashli, Anwar; Weisshaar, Elke

    2015-01-01

    Cutaneous leishmaniasis (CL) is a worldwide disease caused by an infection with the protozoan parasite Leishmania transmitted via sand flies. It is endemic in many of the poorest countries of all continents. "Aleppo boil" is one of the recognised names given to this disease in the medical literature. Although CL used to be well-controlled and well-documented in Syria, its incidence has dramatically increased since the beginning of the war; however, there is lack of documentation. Here, we present the past and current epidemiological situation of the disease in Syria. We also draw attention to gross and highly unusual clinical variants of CL presented to the Department of Dermatology in Aleppo covering the important differential clinical diagnoses, since this disease is already known to mimic other conditions. Diagnostic procedures and treatment as well as prevention are summarised. Due to the increased ability to travel, and especially the flight of Syrians to neighbouring countries, as well as to Europe, CL may become a new threat in formerly unaffected regions. Through this account, we hope to give weight to the aspiration that CL does not remain a neglected and often clinically overlooked tropical dermatosis.

  5. Current status and prospects of clinical proteomics studies on detection of colorectal cancer: Hopes and fears

    Institute of Scientific and Technical Information of China (English)

    ME de Noo; RAEM Tollenaar; AM Deelder; LH Bouwman

    2006-01-01

    Colorectal adenocarcinoma (CRC) is the third most common type of cancer and the fourth most frequent cause of death due to cancer worldwide. Given the natural history of CRC, early diagnosis appears to be the most appropriate tool to reduce disease-related mortality. A field of recent interest is clinical proteomics, which was reported to lead to high sensitivity and specificities for early detection of several solid tumors. This emerging field uses mass spectrometry-based protein profiles/patterns of easy accessible body fluids to distinguish cancer from non-cancer patients. These discrepancies may be a result of: (1) proteins being abnormally produced or shed and added to the serum proteome, (2) proteins clipped or modified as a consequence of the disease process, or (3) proteins subtracted from the proteome owing to disease-related proteolytic degradation pathways. Therefore, protein pattern diagnostics would provide easy and reliable tools for detection of cancer. This paper focuses on the current status of clinical proteomics research in oncology and in colorectal cancer especially,and will reflect on pitfalls and fears in this relatively new area of clinical medicine, which are reproducibility issues and pre-analytical factors, statistical issues, and identification and nature of discriminating proteins/peptides.

  6. Isavuconazole for the treatment of invasive aspergillosis and mucormycosis: current evidence, safety, efficacy, and clinical recommendations

    Science.gov (United States)

    Natesan, Suganthini Krishnan; Chandrasekar, Pranatharthi H

    2016-01-01

    The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA) and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ) seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA) for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. PMID:27994475

  7. CARDIOVASCULAR DISEASES TREATMENT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS IN CURRENT CLINICAL PRACTICE

    Directory of Open Access Journals (Sweden)

    I. E. Sapozhnikova

    2016-01-01

    Full Text Available Aim. To evaluate cardiovascular diseases (CVD treatment in patients with type 2 diabetes mellitus (DM 2 in current clinical practice.Material and methods. A total of 200 patients with DM 2, who consented to take part in the questionnaire, were examined. Questionnaire, clinical and laboratory examinations were conducted.Results. There was a low frequency of CVD recognized and included into clinical diagnosis – angina, history of myocardial infarction and stroke. In majority of the patients decompensated carbohydrate metabolism was observed. This was due to lack of knowledge, inadequate or absent glucose self-monitoring, low frequency of combined glucoselowering therapy. Target level of blood pressure (BP was registered in 16% of hypertensive patients only. Basic reasons of this were: frequently prescribed mono-therapy, irrational combinations, inadequate dosage and frequent omissions of antihypertensive drugs intake and not appropriate BP self-monitoring. Low frequency of statins therapy and non-targeted cholesterol levels were also revealed in examined patients.Conclusion. Improvement of diagnostic tactics in patients with DM 2 is necessary as well as therapy correction taking into account these patients co-morbidity.

  8. CARDIOVASCULAR DISEASES TREATMENT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS IN CURRENT CLINICAL PRACTICE

    Directory of Open Access Journals (Sweden)

    I. E. Sapozhnikova

    2009-01-01

    Full Text Available Aim. To evaluate cardiovascular diseases (CVD treatment in patients with type 2 diabetes mellitus (DM 2 in current clinical practice.Material and methods. A total of 200 patients with DM 2, who consented to take part in the questionnaire, were examined. Questionnaire, clinical and laboratory examinations were conducted.Results. There was a low frequency of CVD recognized and included into clinical diagnosis – angina, history of myocardial infarction and stroke. In majority of the patients decompensated carbohydrate metabolism was observed. This was due to lack of knowledge, inadequate or absent glucose self-monitoring, low frequency of combined glucoselowering therapy. Target level of blood pressure (BP was registered in 16% of hypertensive patients only. Basic reasons of this were: frequently prescribed mono-therapy, irrational combinations, inadequate dosage and frequent omissions of antihypertensive drugs intake and not appropriate BP self-monitoring. Low frequency of statins therapy and non-targeted cholesterol levels were also revealed in examined patients.Conclusion. Improvement of diagnostic tactics in patients with DM 2 is necessary as well as therapy correction taking into account these patients co-morbidity.

  9. Infantile nystagmus syndrome: clinical characteristics, current theories of pathogenesis, diagnosis, and management.

    Science.gov (United States)

    Richards, Michael D; Wong, Agnes

    2015-12-01

    Infantile nystagmus syndrome (INS) is an important clinical diagnosis because it is a common presenting sign of many ocular, neurologic, and systemic diseases. Although INS has been studied for more than a century, its diagnosis and treatment remains a challenge to clinicians because of its varied manifestations and multiple associations, and its pathogenesis continues to rouse considerable scientific debate. Fueled by these challenges, recent basic research and clinical investigations have provided new insights into INS. New genetic discoveries and technological advances in ocular imaging have refined our understanding of INS subtypes and offer new diagnostic possibilities. Unexpected surgical outcomes have led to new understanding of its pathogenesis based on novel hypothesized pathways of ocular motor control. Comparative studies on nonhuman visual systems have also informed models of the neural substrate of INS in humans. This review brings together the classic profile of this disorder with recent research to provide an update on the clinical features of INS, an overview of the current theories on how and why INS develops, and a practical approach to the diagnosis and management of INS.

  10. [Security Management in Clinical Laboratory Departments and Facilities: Current Status and Issues].

    Science.gov (United States)

    Ishida, Haku; Nakamura, Junji; Yoshida, Hiroshi; Koike, Masaru; Inoue, Yuji

    2014-11-01

    We conducted a questionnaire survey regarding the current activities for protecting patients' privacy and the security of information systems (IS) related to the clinical laboratory departments of university hospitals, certified training facilities for clinical laboratories, and general hospitals in Yamaguchi Prefecture. The response rate was 47% from 215 medical institutions, including three commercial clinical laboratory centers. The results showed that there were some differences in management activities among facilities with respect to continuing education, the documentation or regulation of operational management for paper records, electronic information, remaining samples, genetic testing, and laboratory information for secondary use. They were suggested to be caused by differences in functions between university and general hospitals, differences in the scale of hospitals, or whether or not hospitals have received accreditation or ISO 15189. Regarding the IS, although the majority of facilities had sufficiently employed the access control to IS, there was some room for improvement in the management of special cases such as VIPs and patients with HIV infection. Furthermore, there were issues regarding the login method for computers shared by multiple staff, the showing of the names of personnel in charge of reports, and the risks associated with direct connections to systems and the Internet and the use of portable media such as USB memory sticks. These results indicated that further efforts are necessary for each facility to continue self-assessment and make improvements.

  11. [Current recommendations about the diagnosis and treatment of testosterone deficit syndrome: Clinical guidelines].

    Science.gov (United States)

    Valero Rosa, José; Márquez López, Javier; Campos Hernández, Pablo; Puigvert Martínez, Ana; Prieto Castro, Rafael

    2013-09-01

    Testosterone deficit syndrome (TDS) is a clinical and biochemical syndrome associated with advanced age and characterized by some typical symptoms and decrease in serum testosterone levels, which can affect multiple organs and systems, deteriorating the quality of life of the males who suffer it. Due to the low specificity of the clinical picture, as well as that of the commonly used questionnaires, when there is a diagnostic suspicion, serum testosterone determination is necessary, without a current universally accepted determination method. The increased survival of males in the western world and their demand of a better quality of life,including the preservation of sexual activity, up to increasingly more advanced ages: together with the appearance of new ways of testosterone delivery, make this entity, clinical-biochemical, acquirean increasingly greater importance. From a therapeutic point of view, testosterone replacement therapy has precise indications, with individualized evaluation in each patient on the basis of risk/benefit, and with an adequate, well defined follow up, that will allow the control of possible adverse events. TRT is recommended in patients with diminished testosterone associated with muscle mass and strength loss, decrease of bone density of the lumbar spine or diminished libido and quality of erection. Contraindications for therapy would include active or non treated prostate cancer, PSA >4 ng/ml before evaluation, breast cancer, severe sleep apnea, infertility, hematocrit over 50% or severe LUTS due to BPH.

  12. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial

    Science.gov (United States)

    Schittkowski, Michael P.; Antal, Andrea; Ambrus, Géza Gergely; Paulus, Walter; Dannhauer, Moritz; Michalik, Romualda; Mante, Alf; Bola, Michal; Lux, Anke; Kropf, Siegfried; Brandt, Stephan A.; Sabel, Bernhard A.

    2016-01-01

    Background Vision loss after optic neuropathy is considered irreversible. Here, repetitive transorbital alternating current stimulation (rtACS) was applied in partially blind patients with the goal of activating their residual vision. Methods We conducted a multicenter, prospective, randomized, double-blind, sham-controlled trial in an ambulatory setting with daily application of rtACS (n = 45) or sham-stimulation (n = 37) for 50 min for a duration of 10 week days. A volunteer sample of patients with optic nerve damage (mean age 59.1 yrs) was recruited. The primary outcome measure for efficacy was super-threshold visual fields with 48 hrs after the last treatment day and at 2-months follow-up. Secondary outcome measures were near-threshold visual fields, reaction time, visual acuity, and resting-state EEGs to assess changes in brain physiology. Results The rtACS-treated group had a mean improvement in visual field of 24.0% which was significantly greater than after sham-stimulation (2.5%). This improvement persisted for at least 2 months in terms of both within- and between-group comparisons. Secondary analyses revealed improvements of near-threshold visual fields in the central 5° and increased thresholds in static perimetry after rtACS and improved reaction times, but visual acuity did not change compared to shams. Visual field improvement induced by rtACS was associated with EEG power-spectra and coherence alterations in visual cortical networks which are interpreted as signs of neuromodulation. Current flow simulation indicates current in the frontal cortex, eye, and optic nerve and in the subcortical but not in the cortical regions. Conclusion rtACS treatment is a safe and effective means to partially restore vision after optic nerve damage probably by modulating brain plasticity. This class 1 evidence suggests that visual fields can be improved in a clinically meaningful way. Trial Registration ClinicalTrials.gov NCT01280877 PMID:27355577

  13. Clinical and experimental studies on polyherbal formulations for diabetes:current status and future prospective

    Institute of Scientific and Technical Information of China (English)

    Ahmad Ghorbani

    2014-01-01

    Diabetes is a leading cause of morbidity and mortality in the world. There is currently an active search for antidiabetic drugs with greater effectiveness with fewer and less adverse side effects. Although numerous individual herbs have been experimentally or clinically reported to possess antidiabetic effects, considerably less research has been conducted on polyherbal compounds. It is believed that herbal compounds containing multiple plant products have synergistic antidiabetic effects and could enhance the desired actions. Several polyherbal formulations have been studied as therapeutic agents in diabetes management. To describe the current state of research on polyherbal compounds in the treatment of diabetes, an extensive review of literature was undertaken on several major databases. This paper presents what is known about the efifcacy of these polyherbal formulations and compare their antidiabetic effects with those of current oral hypoglycemic drugs as reference. The percent decrease in blood glucose, lipids and other biochemical parameters achieved by each product in diabetic animals and patients is reported. Also, the possible mechanisms responsible for hypoglycemic action of polyherbal formulations are discussed.

  14. The benchmark analysis of gastric, colorectal and rectal cancer pathways: toward establishing standardized clinical pathway in the cancer care.

    Science.gov (United States)

    Ryu, Munemasa; Hamano, Masaaki; Nakagawara, Akira; Shinoda, Masayuki; Shimizu, Hideaki; Miura, Takeshi; Yoshida, Isao; Nemoto, Atsushi; Yoshikawa, Aki

    2011-01-01

    Most clinical pathways in treating cancers in Japan are based on individual physician's personal experiences rather than on an empirical analysis of clinical data such as benchmark comparison with other hospitals. Therefore, these pathways are far from being standardized. By comparing detailed clinical data from five cancer centers, we have observed various differences among hospitals. By conducting benchmark analyses, providing detailed feedback to the participating hospitals and by repeating the benchmark a year later, we strive to develop more standardized clinical pathways for the treatment of cancers. The Cancer Quality Initiative was launched in 2007 by five cancer centers. Using diagnosis procedure combination data, the member hospitals benchmarked their pre-operative and post-operative length of stays, the duration of antibiotics administrations and the post-operative fasting duration for gastric, colon and rectal cancers. The benchmark was conducted by disclosing hospital identities and performed using 2007 and 2008 data. In the 2007 benchmark, substantial differences were shown among five hospitals in the treatment of gastric, colon and rectal cancers. After providing the 2007 results to the participating hospitals and organizing several brainstorming discussions, significant improvements were observed in the 2008 data study. The benchmark analysis of clinical data is extremely useful in promoting more standardized care and, thus in improving the quality of cancer treatment in Japan. By repeating the benchmark analyses, we can offer truly clinical evidence-based higher quality standardized cancer treatment to our patients.

  15. Achilles Tendinopathy: Current Concepts about the Basic Science and Clinical Treatments.

    Science.gov (United States)

    Li, Hong-Yun; Hua, Ying-Hui

    2016-01-01

    Achilles tendinopathy is one of the most frequently ankle and foot overuse injuries, which is a clinical syndrome characterized by the combination of pain, swelling, and impaired performance. The two main categories of Achilles tendinopathy are classified according to anatomical location and broadly include insertional and noninsertional tendinopathy. The etiology of Achilles tendinopathy is multifactorial including both intrinsic and extrinsic factors. Failed healing response and degenerative changes were found in the tendon. The failed healing response includes three different and continuous stages (reactive tendinopathy, tendon disrepair, and degenerative tendinopathy). The histological studies have demonstrated an increased number of tenocytes and concentration of glycosaminoglycans in the ground substance, disorganization and fragmentation of the collagen, and neovascularization. There are variable conservative and surgical treatment options for Achilles tendinopathy. However, there has not been a gold standard of these treatments because of the controversial clinical results between various studies. In the future, new level I researches will be needed to prove the effect of these treatment options.

  16. Achilles Tendinopathy: Current Concepts about the Basic Science and Clinical Treatments

    Directory of Open Access Journals (Sweden)

    Hong-Yun Li

    2016-01-01

    Full Text Available Achilles tendinopathy is one of the most frequently ankle and foot overuse injuries, which is a clinical syndrome characterized by the combination of pain, swelling, and impaired performance. The two main categories of Achilles tendinopathy are classified according to anatomical location and broadly include insertional and noninsertional tendinopathy. The etiology of Achilles tendinopathy is multifactorial including both intrinsic and extrinsic factors. Failed healing response and degenerative changes were found in the tendon. The failed healing response includes three different and continuous stages (reactive tendinopathy, tendon disrepair, and degenerative tendinopathy. The histological studies have demonstrated an increased number of tenocytes and concentration of glycosaminoglycans in the ground substance, disorganization and fragmentation of the collagen, and neovascularization. There are variable conservative and surgical treatment options for Achilles tendinopathy. However, there has not been a gold standard of these treatments because of the controversial clinical results between various studies. In the future, new level I researches will be needed to prove the effect of these treatment options.

  17. Giant cell tumor of bone: current review of morphological, clinical, radiological, and therapeutic characteristics

    Directory of Open Access Journals (Sweden)

    Georgi P. Georgiev

    2014-09-01

    Full Text Available Giant cell tumor of bone accounts for about 5% of all primary bone tumors in adults and is still one of the most obscure and intensively examined tumors of bone. This largely results from the lack of uniform clinical, radiographic, histological or morphological aspects that allow prediction of recurrence. Classified by the World Health Organization as “an aggressive, potentially malignant lesion”, the giant cell tumor of bone could give lung metastases, could undergo malignant degeneration or could have multicentric localization. It usually develops in long bones but can also occur in unusual locations. The common presenting symptom is increasing pain at the tumor site. Standard treatment ranges from curettage to wide resection, with reports of varying oncological and functional results. The recurrence rate is high during the first 2-3 years after surgery regardless of pre-operative tumor stage. Herein, we discuss the morphological, clinical, radiological, and therapeutic characteristics of this pathologic entity as well as its differential diagnosis. J Clin Exp Invest 2014; 5 (3: 475-485

  18. Policies for patient access to clinical data via PHRs: current state and recommendations.

    Science.gov (United States)

    Collins, Sarah A; Vawdrey, David K; Kukafka, Rita; Kuperman, Gilad J

    2011-12-01

    Healthcare delivery organizations are increasingly using online personal health records (PHRs) to provide patients with direct access to their clinical information; however, there may be a lack of consistency in the data made available. We aimed to understand the general use and functionality of PHRs and the organizational policies and decision-making structures for making data available to patients. A cross-sectional survey was administered by telephone structured interview to 21 organizations to determine the types of data made available to patients through PHRs and the presence of explicit governance for PHR data release. Organizations were identified based on a review of the literature, PHR experts, and snowball sampling. Organizations that did not provide patients with electronic access to their data via a PHR were excluded. Interviews were conducted with 17 organizations for a response rate of 81%. Half of the organizations had explicit governance in the form of a written policy that outlined the data types made available to patients. Overall, 88% of the organizations used a committee structure for the decision-making process and included senior management and information services. All organizations sought input from clinicians. Discussion There was considerable variability in the types of clinical data and the time frame for releasing these data to patients. Variability in data release policies may have implications for PHR use and adoption. Future policy activities, such as requirement specification for the latter stages of Meaningful Use, should be leveraged as an opportunity to encourage standardization of functionality and broad deployment of PHRs.

  19. Clinical Approach to the Standardization of Oriental Medical Diagnostic Pattern Identification in Stroke Patients

    Directory of Open Access Journals (Sweden)

    Han Jung Kim

    2011-01-01

    Full Text Available In Korea, many stroke patients receive oriental medical care, in which pattern-identification plays a major role. Pattern-identification is Oriental Medicine's unique diagnostic system. This study attempted to standardize oriental medical pattern-identification for stroke patients. This was a community-based multicenter study that enrolled stroke patients within 30 days after their ictus. We assessed the patients' general characteristics and symptoms related to pattern-identification. Each patient's pattern was determined when two doctors had the same opinion. To determine which variables affect the pattern-identification, binary logistic regression analysis was used with the backward method. A total of 806 stroke patients were enrolled. Among 480 patients who were identified as having a certain pattern, 100 patients exhibited the Fire Heat Pattern, 210 patients the Phlegm Dampness Pattern, nine patients the Blood Stasis Pattern, 110 patients the Qi Deficiency Pattern, and 51 patients the Yin Deficiency Pattern. After the regression analysis, the predictive logistic equations for the Fire Heat, Phlegm Dampness, Qi Deficiency, and Yin Deficiency patterns were determined. The Blood Stasis Pattern was omitted because the sample size was too small. Predictive logistic equations were suggested for four of the patterns. These criteria would be useful in determining each stroke patient's pattern in clinics. However, further studies with large samples are necessary to validate and confirm these criteria.

  20. Comparison between Clinically Used Irregular Fields Shielded by Cerrobend and Standard Lead Blocks

    Directory of Open Access Journals (Sweden)

    Farajollahi A. R.

    2015-06-01

    Full Text Available Introduction: In radiation therapy centers across Iran, protection of normal tissues is usually accomplished by either Cerrobend or lead block shielding. In this study, the influence of these two shielding methods on central axis dose distribution of photon beam a Cobalt unit was investigated in clinical conditions. Materials and Methods: All measurements were performed for 60Co γ-ray beams and the Cerrobend blocks were fabricated by commercial Cerrobend materials. Standard lead block shields belonged to Cobalt unit. Data was collected through a calibrated ionization chamber, relative dosimetry systems and a TLD dosimetery. Results: Results of the percent depth dose (PDD measurements at depths of 0.5, 1, 5, 10, 15 and 20 cm for 23 different field sizes of patients with head and neck cancer showed no significant differences between lead and Cerrobend shielding methods. Measurement results of absolute dosimetry in depths of 1.5, 3, 5, 7, 10 and 12 cm also showed no significant differences between these two shielding methods. The same results were obtained by TLD dosimetry on patient skin. Conclusion: Use of melt shielding methods is a very easy and fast shield-making technique with no differences in PDD, absolute and skin dose between lead and Cerrobend block shielding methods.

  1. Implementing the K-SADS-PL as a standard diagnostic tool: Effects on clinical diagnoses.

    Science.gov (United States)

    Matuschek, Tina; Jaeger, Sonia; Stadelmann, Stephanie; Dölling, Katrin; Grunewald, Madlen; Weis, Steffi; von Klitzing, Kai; Döhnert, Mirko

    2016-02-28

    Diagnostic interviews are valuable tools for generating reliable and valid psychiatric diagnoses. However, little is known about the diagnostic effects of implementing such an interview into the standard diagnostic procedure of a child psychiatric clinic. Therefore, we reviewed discharge diagnoses of psychiatric patients (age: 8-12 years; combined sample of inpatients and day hospital patients) over two intervals before and after implementing the semi-structured diagnostic interview K-SADS-PL as a diagnostic tool during intake. Each interval was a two year period spanning from 2009-2010 (pre sample; n=177) and from 2012-2013 (post sample; n=132). The number of diagnoses per patient and the co-morbidity rate increased significantly in the post sample. Furthermore, the percentage of children with a nonspecific diagnosis "other mixed disorders of conduct and emotions" (ICD-10: F92.8) decreased significantly after using the K-SADS-PL. Regarding the main diagnostic categories, a significant increase in the number of anxiety disorders and stress-related and somatoform disorders was found in the post sample. The results suggest that implementing a semi-structured interview into the daily routine of child psychiatry may have a substantial impact on discharge diagnoses. Practical implications are discussed and ideas for future research are given.

  2. [A progress in the standardization in clinical enzymology using calibrators adapted to several techniques].

    Science.gov (United States)

    Dourson, J L; Lessinger, J M; Férard, G

    1997-01-01

    Results in enzymology obtained in routine conditions, differ considerably according to the measurement procedures, and the use of conversion factors is not an advisable solution. Some studies show that between-laboratory agreement of results can be improved by using validated enzyme calibrators. The conditions, which are required to define a strategy for the development of such calibrators, are described in a first part. The example of lipase activity, which is measured in routine conditions with important between-method discrepancy, is studied in a second part. This example emphasised the need of an a priori control of the validity of the calibrators. Under these conditions, between-method agreement is in fact considerably improved. With the collaboration of manufacturers for the development of validated enzyme multicalibrators, it will be possible to improve the efficiency of the information transmitted by clinical chemists to clinicians. Thus, enzyme activities measurements could benefit from the same improvement as immunoassay of proteins with the use of CRM 470 by manufacturers to calibrate their standards.

  3. Comparison between Clinically Used Irregular Fields Shielded by Cerrobend and Standard Lead Blocks.

    Science.gov (United States)

    Farajollahi, A R; Bouzarjomehri, F; Kiani, M

    2015-06-01

    In radiation therapy centers across Iran, protection of normal tissues is usually accomplished by either Cerrobend or lead block shielding. In this study, the influence of these two shielding methods on central axis dose distribution of photon beam a Cobalt unit was investigated in clinical conditions. All measurements were performed for 60Co γ-ray beams and the Cerrobend blocks were fabricated by commercial Cerrobend materials. Standard lead block shields belonged to Cobalt unit. Data was collected through a calibrated ionization chamber, relative dosimetry systems and a TLD dosimetery. Results of the percent depth dose (PDD) measurements at depths of 0.5, 1, 5, 10, 15 and 20 cm for 23 different field sizes of patients with head and neck cancer showed no significant differences between lead and Cerrobend shielding methods. Measurement results of absolute dosimetry in depths of 1.5, 3, 5, 7, 10 and 12 cm also showed no significant differences between these two shielding methods. The same results were obtained by TLD dosimetry on patient skin. Use of melt shielding methods is a very easy and fast shield-making technique with no differences in PDD, absolute and skin dose between lead and Cerrobend block shielding methods.

  4. Harmonizing and extending standards from a domain-specific and bottom-up approach: an example from development through use in clinical applications.

    Science.gov (United States)

    Harris, Marcelline R; Langford, Laura Heermann; Miller, Holly; Hook, Mary; Dykes, Patricia C; Matney, Susan A

    2015-05-01

    Currently, the processes for harmonizing and extending standards by leveraging the knowledge within local documentation artifacts are not well described. We describe a collaborative project to develop common information models, terminology bindings, and term definitions based on nursing documentation systems, and carry the findings through to the adoption in standards development organizations (SDOs) and technical implementations in clinical applications. Nursing flowsheet documents from six large organizations were analyzed to generate a common information model and terminologies that fully expressed documentation across all systems, and were sufficient for evidence-based decision support, reporting, and analysis. Significant gaps in existing standards were identified. The models and terminologies were submitted to and incorporated by SDOs, are published, implemented, and now serving as a foundation for an eMeasure. There are few examples in the literature of success working through the standards development process from a bottom-up perspective. Subsequently, standards do not yet fully address the need for detailed clinical data that enables, for example, decision support as well as a range of reporting and analytic requirements. Recommendations from this project include transparent processes within SDOs, registries that make models and associated terminologies freely available, and coordinated governance processes. We demonstrated the feasibility of using documentation artifacts in a bottom-up approach to develop common models and sets of terms that are complete from the perspective of clinical implementation. Importantly, we demonstrated a process by which a community of practice can contribute to closing gaps in existing standards using SDO processes. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  5. National Institute of Standards and Technology measurement service of the optical properties of biomedical phantoms: current status

    Science.gov (United States)

    Lemaillet, Paul; Cooksey, Catherine C.; Levine, Zachary H.; Pintar, Adam L.; Hwang, Jeeseong; Allen, David W.

    2016-03-01

    The National Institute of Standards and Technology (NIST) has maintained scales for reflectance and transmittance over several decades. The scales are primarily intended for regular transmittance, mirrors, and solid surface scattering diffusers. The rapidly growing area of optical medical imaging needs a scale for volume scattering of diffuse materials that are used to mimic the optical properties of tissue. Such materials are used as phantoms to evaluate and validate instruments under development intended for clinical use. To address this need, a double-integrating sphere based instrument has been installed to measure the optical properties of tissue-mimicking phantoms. The basic system and methods have been described in previous papers. An important attribute in establishing a viable calibration service is the estimation of measurement uncertainties. The use of custom models and comparisons with other established scales enabled uncertainty measurements. Here, we describe the continuation of those efforts to advance the understanding of the uncertainties through two independent measurements: the bidirectional reflectance distribution function and the bidirectional transmittance distribution function of a commercially available solid biomedical phantom. A Monte Carlo-based model is used and the resulting optical properties are compared to the values provided by the phantom manufacturer.

  6. Creating an educationally minded schedule: one approach to minimize the impact of duty hour standards on intern continuity clinic experience.

    Science.gov (United States)

    DeBlasio, Dominick; Kerrey, M Kathleen; Sucharew, Heidi; Klein, Melissa

    2014-11-01

    To determine if implementing an educationally minded schedule utilizing consecutive night shifts can moderate the impact of the 2011 duty hour standards on education and patient continuity of care in longitudinal primary care experience (continuity clinic). A 14-month pre-post study was performed in continuity clinic with one supervising physician group and two intern groups. Surveys to assess attitudes and education were distributed to the supervising physicians and interns before and after the changes in duty hour standards. Intern groups' schedules were reviewed for the number of regular and alternative day clinic (i.e. primary care experience on a different weekday) sessions and patient continuity of care. Fifteen supervising physicians and 51 interns participated (25 in 2011, 26 in 2012). Intern groups' comfort when discussing patient issues, educational needs and teamwork perception did not differ. Supervising physicians' understanding of learning needs and provision of feedback did not differ between groups. Supervising physicians indicated a greater ability to provide feedback and understand learning needs during regular continuity clinic sessions compared with alternative day clinics (all p intern groups in the number of regularly scheduled continuity clinics, alternative day clinics or patient continuity of care. The 2011 duty hour standards required significant alterations to intern schedules, but educationally minded scheduling limited impact on education and patient continuity in care.

  7. Recommendations for Standardizing Glucose Reporting and Analysis to Optimize Clinical Decision Making in Diabetes: The Ambulatory Glucose Profile

    OpenAIRE

    Bergenstal, Richard M.; Ahmann, Andrew J.; Bailey, Timothy; Beck, Roy W.; Bissen, Joan; Buckingham, Bruce; Deeb, Larry; Dolin, Robert H.; Garg, Satish K.; Goland, Robin; Hirsch, Irl B.; Klonoff, David C.; Kruger, Davida F; Matfin, Glenn; Mazze, Roger S.

    2013-01-01

    Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes mellitus. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardizing the analysis and presentation of glucose monitoring da...

  8. Improving performance in golf: current research and implications from a clinical perspective

    Directory of Open Access Journals (Sweden)

    Kerrie Evans

    2015-10-01

    Full Text Available ABSTRACTGolf, a global sport enjoyed by people of all ages and abilities, involves relatively long periods of low intensity exercise interspersed with short bursts of high intensity activity. To meet the physical demands of full swing shots and the mental and physical demands of putting and walking the course, it is frequently recommended that golfers undertake golf-specific exercise programs. Biomechanics, motor learning, and motor control research has increased the understanding of the physical requirements of the game, and using this knowledge, exercise programs aimed at improving golf performance have been developed. However, while it is generally accepted that an exercise program can improve a golfer's physical measurements and some golf performance variables, translating the findings from research into clinical practice to optimise an individual golfer's performance remains challenging. This paper discusses how biomechanical and motor control research has informed current practice and discusses how emerging sophisticated tools and research designs may better assist golfers improve their performance.

  9. SHORT OVERVIEW OF CLINICAL TRIALS WITH CURRENT IMMUNOTHERAPEUTIC TOOLS FOR CANCER TREATMENT

    Directory of Open Access Journals (Sweden)

    T. S. Nepomnyashchikh

    2017-01-01

    Full Text Available Over last decade, a substantial progress has been made, with respect to understanding of cancer biology and its interplay with the host immune system. Different immunotherapeutic drugs based on recombinant cytokines and monoclonal antibodies are widely used in cancer therapy, and a large number of experimental cancer treatments have been developed, many of which are currently undergoing various stages of clinical trials. Recent endorsement of a recombinant oncolytic herpesvirus T-VEC for the treatment of melanoma was an important step towards a more safe and efficient anticancer therapeutics. In this review, we shall mention only some of the most promising cancer immunotherapy strategies, namely, immune checkpoint inhibitors, cellular therapy and oncolytic viruses. 

  10. The metabolic syndrome in patients with alcohol dependency: Current research and clinical implications.

    Science.gov (United States)

    Kahl, Kai G; Hillemacher, Thomas

    2016-10-01

    The relationship between alcohol dependency and disorders such as liver disease and cancer has been thoroughly researched. However, the effects of alcohol on cardiometabolic health remain controversial. Several reports found low to moderate alcohol consumption to be associated with a lower risk for cardiometabolic disorders. In contrast, excessive alcohol consumption has been related to an increased risk. Most of these studies were performed in non-clinical populations, therefore limiting the explanatory power to non-dependent patients. Only a few studies examined cardiovascular disorders and cardiovascular risk factors, in particular the metabolic syndrome (MetS), in alcohol dependent patients. We here present a narrative review of studies performed so far on the MetS in alcohol dependency, and provide current hypotheses on the association of alcohol dependency, appetite regulation and the development of the MetS.

  11. Clinical utility of current-generation dipole modelling of scalp EEG.

    Science.gov (United States)

    Plummer, C; Litewka, L; Farish, S; Harvey, A S; Cook, M J

    2007-11-01

    To investigate the clinical utility of current-generation dipole modelling of scalp EEG in focal epilepsies seen commonly in clinical practice. Scalp EEG recordings from 10 patients with focal epilepsy, five with Benign Focal Epilepsy of Childhood (BFEC) and five with Mesial Temporal Lobe Epilepsy (MTLE), were used for interictal spike dipole modelling using Scan 4.3 and CURRY 5.0. Optimum modelling parameters for EEG source localisation (ESL) were sought by the step-wise application of various volume conductor (forward) and dipole (inverse) models. Best-fit ESL solutions (highest explained forward-fit to measured data variance) were used to characterise best-fit forward and inverse models, regularisation effect, additional electrode effect, single-to-single spike and single-to-averaged spike variability, and intra- and inter-operator concordance. Inter-parameter relationships were examined. Computation times and interface problems were recorded. For both BFEC and MTLE, the best-fit forward model was the finite element method interpolated (FEMi) model, while the best-fit single dipole models were the rotating non-regularised and the moving regularised models. When combined, these forward-inverse models appeared to offer clinically meaningful ESL results when referenced to an averaged cortex overlay, best-fit dipoles localising to the central fissure region in BFEC and to the basolateral temporal region in MTLE. Single-to-single spike and single-to-averaged spike measures of concordance for dipole location and orientation were stronger for BFEC versus MTLE. The use of an additional pair of inferior temporal electrodes in MTLE directed best-fit dipoles towards the basomesial temporal region. Inverse correlations were noted between unexplained variance (RD) and dipole strength (Amp), RD and signal to noise ratio (SNR), and SNR and confidence ellipsoid (CE) volume. Intra- and inter-operator levels of agreement were relatively robust for dipole location and orientation

  12. Radiology of HIV/AIDS in China: Current status and clinical application

    Directory of Open Access Journals (Sweden)

    Hongjun Li

    2015-06-01

    Full Text Available HIV infection targets at the human in the human body and targeting damage to immune system to compromise the result in hypoimmunity. HIV associated damages to tissues and organs as well as AIDS related infections caused by various pathogens and neoplasms are clinically common. AIDS related diseases are the main cause of death in patients with AIDS. Therefore, early prevention as well as appropriate and immediate treatment against AIDS related diseases play key role in prolonging the survival period and improving quality of life in patients with AIDS. In recent years, medical radiology has gained rapid development, which plays an important role in diagnosing and treating HIV/AIDS related diseases. The findings by medical radiology constitute an important chain of evidence for HIV/AIDS related diseases. Developed from traditional morphological radiology to current functional and molecular radiology, the modern medical radiology is providing a flood of diagnostic information to guide clinical practice. It is expected to provide accurate data for the location of lesions as well as quantitatively and qualitatively radiological diagnosis. Based on the radiological data, the goal of individualized treatment can be achieved.

  13. Clinical utility of trabectedin for the treatment of ovarian cancer: current evidence

    Directory of Open Access Journals (Sweden)

    Mascilini F

    2014-07-01

    Full Text Available Floriana Mascilini,* Giulia Amadio,* Maria Grazia Di Stefano, Manuela Ludovisi, Alessia Di Legge, Carmine Conte, Rosa De Vincenzo, Caterina Ricci, Valeria Masciullo, Vanda Salutari, Giovanni Scambia, Gabriella FerrandinaGynecologic Oncology Unit, Department of Oncology, Catholic University of Rome, Italy  *These authors contributed equally to this work Abstract: Among the pharmaceutical options available for treatment of ovarian cancer, attention has been increasingly focused on trabectedin (ET-743, a drug which displays a unique mechanism of action and has been shown to be active in several human malignancies. Currently, single agent trabectedin is approved for treatment of patients with advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide, and in association with pegylated liposomal doxorubicin for treatment of patients with relapsed partially platinum-sensitive ovarian cancer. This review aims at summarizing the available evidence about the clinical role of trabectedin in the management of patients with epithelial ovarian cancer. Novel perspectives coming from a better understanding of trabectedin mechanisms of action and definition of patients subgroups likely susceptible to benefit of trabectedin treatment are also presented. Keywords: ET-743, ovarian cancer, clinical trials

  14. Human iPS Cell-Derived Germ Cells: Current Status and Clinical Potential.

    Science.gov (United States)

    Ishii, Tetsuya

    2014-10-13

    Recently, fertile spermatozoa and oocytes were generated from mouse induced pluripotent (iPS) cells using a combined in vitro and in vivo induction system. With regard to germ cell induction from human iPS cells, progress has been made particularly in the male germline, demonstrating in vitro generation of haploid, round spermatids. Although iPS-derived germ cells are expected to be developed to yield a form of assisted reproductive technology (ART) that can address unmet reproductive needs, genetic and/or epigenetic instabilities abound in iPS cell generation and germ cell induction. In addition, there is still room to improve the induction protocol in the female germline. However, rapid advances in stem cell research are likely to make such obstacles surmountable, potentially translating induced germ cells into the clinical setting in the immediate future. This review examines the current status of the induction of germ cells from human iPS cells and discusses the clinical potential, as well as future directions.

  15. Human iPS Cell-Derived Germ Cells: Current Status and Clinical Potential

    Directory of Open Access Journals (Sweden)

    Tetsuya Ishii

    2014-10-01

    Full Text Available Recently, fertile spermatozoa and oocytes were generated from mouse induced pluripotent (iPS cells using a combined in vitro and in vivo induction system. With regard to germ cell induction from human iPS cells, progress has been made particularly in the male germline, demonstrating in vitro generation of haploid, round spermatids. Although iPS-derived germ cells are expected to be developed to yield a form of assisted reproductive technology (ART that can address unmet reproductive needs, genetic and/or epigenetic instabilities abound in iPS cell generation and germ cell induction. In addition, there is still room to improve the induction protocol in the female germline. However, rapid advances in stem cell research are likely to make such obstacles surmountable, potentially translating induced germ cells into the clinical setting in the immediate future. This review examines the current status of the induction of germ cells from human iPS cells and discusses the clinical potential, as well as future directions.

  16. Isavuconazole for the treatment of invasive aspergillosis and mucormycosis: current evidence, safety, efficacy, and clinical recommendations

    Directory of Open Access Journals (Sweden)

    Natesan SK

    2016-12-01

    Full Text Available Suganthini Krishnan Natesan,1,2 Pranatharthi H Chandrasekar1 1Division of Infectious Diseases, Department of Internal Medicine, Wayne State University, 2John D Dingell VA Medical Center, Detroit, MI, USA Abstract: The majority of invasive mold infections diagnosed in immunocompromised cancer patients include invasive aspergillosis (IA and mucormycosis. Despite timely and effective therapy, mortality remains considerable. Antifungal agents currently available for the management of these serious infections include triazoles, polyenes, and echinocandins. Until recently, posaconazole has been the only triazole with a broad spectrum of anti-mold activity against both Aspergillus sp. and mucorales. Other clinically available triazoles voriconazole and itraconazole, with poor activity against mucorales, have significant drug interactions in addition to a side effect profile inherent for all triazoles. Polyenes including lipid formulations pose a problem with infusion-related side effects, electrolyte imbalance, and nephrotoxicity. Echinocandins are ineffective against mucorales and are approved as salvage therapy for refractory IA. Given that all available antifungal agents have limitations, there has been an unmet need for a broad-spectrum anti-mold agent with a favorable profile. Following phase III clinical trials that started in 2006, isavuconazole (ISZ seems to fit this profile. It is the first novel triazole agent recently approved by the United States Food and Drug Administration (FDA for the treatment of both IA and mucormycosis. This review provides a brief overview of the salient features of ISZ, its favorable profile with regard to spectrum of antifungal activity, pharmacokinetic and pharmacodynamic parameters, drug interactions and tolerability, clinical efficacy, and side effects. Keywords: isavuconazole, aspergillosis, mucormycosis, efficacy, antifungal therapy, novel azole, tolerability, drug interactions

  17. 75 FR 32950 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-06-10

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  18. 75 FR 45128 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-08-02

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  19. 75 FR 27348 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-05-14

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in order to...

  20. 75 FR 16813 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-04-02

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... Engaged in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  1. 75 FR 5088 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-02-01

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  2. 75 FR 9229 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-03-01

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  3. 75 FR 55795 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-09-14

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  4. 75 FR 39023 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-07-07

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory... in Urine Drug Testing for Federal Agencies,'' sets strict standards that laboratories must meet in...

  5. Standards-Based Classroom Assessments of English Proficiency: A Review of Issues, Current Developments, and Future Directions for Research

    Science.gov (United States)

    Llosa, Lorena

    2011-01-01

    With the United States' adoption of a standards-based approach to education, most attention has focused on the large-scale, high-stakes assessments intended to measure students' mastery of standards for accountability purposes. Less attention has been paid to the role of standards-based assessments in the classroom. The purpose of this paper is to…

  6. Clinical Application of Six Current Classification Systems for Iatrogenic Bile Duct Injuries after Cholecystectomy.

    Science.gov (United States)

    Velidedeoglu, Mehmet; Arikan, Akif Enes; Uludag, Sezgin Server; Olgun, Deniz Cebi; Kilic, Fahrettin; Kapan, Metin

    2015-05-01

    Due to being a severe complication, iatrogenic bile duct injury is still a challenging issue for surgeons in gallbladder surgery. However, a commonly accepted classification describing the type of injury has not been available yet. This study aims to evaluate ability of six current classification systems to discriminate bile duct injury patterns. Twelve patients, who were referred to our clinic because of iatrogenic bile duct injury after laparoscopic cholecystectomy were reviewed retrospectively. We described type of injury for each patient according to current six different classifications. 9 patients underwent definitive biliary reconstruction. Bismuth, Strasberg-Bismuth, Stewart-Way and Neuhaus classifications do not consider vascular involvement, Siewert system does, but only for the tangential lesions without structural loss of duct and lesion with a structural defect of hepatic or common bile duct. Siewert, Neuhaus and Stewart-Way systems do not discriminate between lesions at or above bifurcation of the hepatic duct. The Hannover classification may resolve the missing aspects of other systems by describing additional vascular involvement and location of the lesion at or above bifurcation.

  7. Lymphoma: current status of clinical and preclinical imaging with radiolabeled antibodies

    Energy Technology Data Exchange (ETDEWEB)

    England, Christopher G. [University of Wisconsin School of Medicine and Public Health, Department of Medical Physics, Madison, WI (United States); Rui, Lixin [University of Wisconsin School of Medicine and Public Health, Department of Medicine, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Carbone Cancer Center, Madison, WI (United States); Cai, Weibo [University of Wisconsin School of Medicine and Public Health, Department of Medical Physics, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Carbone Cancer Center, Madison, WI (United States); University of Wisconsin School of Medicine and Public Health, Department of Radiology, Madison, WI (United States)

    2017-03-15

    Lymphoma is a complex disease that arises from cells of the immune system with an intricate pathology. While lymphoma may be classified as Hodgkin or non-Hodgkin, each type of tumor is genetically and phenotypically different and highly invasive tissue biopsies are the only method to investigate these differences. Noninvasive imaging strategies, such as immunoPET, can provide a vital insight into disease staging, monitoring treatment response in patients, and dose planning in radioimmunotherapy. ImmunoPET imaging with radiolabeled antibody-based tracers may also assist physicians in optimizing treatment strategies and enhancing patient stratification. Currently, there are two common biomarkers for molecular imaging of lymphoma, CD20 and CD30, both of which have been considered for investigation in preclinical imaging studies. In this review, we examine the current status of both preclinical and clinical imaging of lymphoma using radiolabeled antibodies. Additionally, we briefly investigate the role of radiolabeled antibodies in lymphoma therapy. As radiolabeled antibodies play critical roles in both imaging and therapy of lymphoma, the development of novel antibodies and the discovery of new biomarkers may greatly affect lymphoma imaging and therapy in the future. (orig.)

  8. Standardization of Clinical Skill Evaluation in Physical/Occupational Therapist Education -Effects of Introduction of an Education System Using OSCE-.

    Science.gov (United States)

    Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo

    2013-09-01

    [Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE.

  9. Current Antibiotic Resistance Trend in Clinical Isolates of Staphylococcus aureus from a Tertiary Care Hospital

    Directory of Open Access Journals (Sweden)

    Zahra Ravesh-Barakzai

    2015-10-01

    Full Text Available Background: Staphylococcus aureus (S. aureus has remained always an important pathogen of common infections acquired in community and as  well as serious nosocomial infections. With advent of penicillins and cephalosporins, infections could be effectively treated, but with the global emergence of Methicillin Resistant Staphylococcus aureus strains (MRSA physicians were  again left  with limited treatment options. This scenario of increasing resistance is even more intense and challenging for developing countries like Pakistan. Hence with this background the study was carried out to establish the frequency of MRSA in clinical specimens and look into the available antibiotic treatment options.Methods: Samples of  pus, blood, urine, body fluids and catheter tips submitted for culture  in  Microbiology department between  August  to  September  2012,  from outdoor and indoor adult patients of Pakistan Institute of Medical Sciences Islamabad, yielding growth of S. aureus were included in the study. After identification by  standard  methods, antibiotic susceptibility of  the  isolates  was performed by Kirby Baeur disc diffusion method. The study was retrospective descriptive and observational.Results: Total  106  S.  aureus  were  isolated. 45.3%  of  them  were  MRSA  and majorities were from pus samples of hospitalized patients. All MRSA were 100% sensitive to vancomycin, whereas 87.5% to chloramphenicol. To rest of the non – beta lactam drugs, resistance of 80% or more was noted.Conclusion: S. aureus is a common clinical isolate from patients in this region ofPakistan and significant number were MRSA especially from hospitalized patients. Treatment options are limited to vancomycin and chloramphenicol.

  10. Using a clinical protocol for orthognathic surgery and assessing a 3-dimensional virtual approach: current therapy.

    Science.gov (United States)

    Quevedo, Luis A; Ruiz, Jessica V; Quevedo, Cristobal A

    2011-03-01

    Oral and maxillofacial surgeons who perform orthognathic surgery face major changes in their practices, and these challenges will increase in the near future, because the extraordinary advances in technology applied to our profession are not only amazing but are becoming the standard of care as they promote improved outcomes for our patients. Orthognathic surgery is one of the favorite areas of practicing within the scope of practice of an oral and maxillofacial surgeon. Our own practice in orthognathic surgery has completed over 1,000 surgeries of this type. Success is directly related to the consistency and capability of the surgical-orthodontic team to achieve predictable, stable results, and our hypothesis is that a successful result is directly related to the way we take our records and perform diagnosis and treatment planning following basic general principles. Now that we have the opportunity to plan and treat 3-dimensional (3D) problems with 3D technology, we should enter into this new era with appropriate standards to ensure better results, instead of simply enjoying these new tools, which will clearly show not only us but everyone what we do when we perform orthognathic surgery. Appropriate principles need to be taken into account when implementing this new technology. In other words, new technology is welcome, but we do not have to reinvent the wheel. The purpose of this article is to review the current protocol that we use for orthognathic surgery and compare it with published protocols that incorporate new 3D and virtual technology. This report also describes our approach to this new technology.

  11. Appraising fertilisers: origins of current regulations and standards for contaminants in fertilisers : background of quality standards in the Netherlands, Denmark, Germany, United Kingdom and Flanders

    NARCIS (Netherlands)

    Ehlert, P.A.I.; Posthuma, L.; Römkens, P.F.A.M.; Rietra, R.P.J.J.; Wintersen, A.M.; Wijnen, van H.; Dijk, van T.A.; Schöll, van L.; Groenenberg, J.E.

    2013-01-01

    The standards for contaminants in fertilisers in Denmark, Germany, Flanders, the Netherlands and United Kingdom, are given in the context of the proposals for new European fertiliser legislation. This EU legislation might result in generic limit values for contaminants and input lists of materials,

  12. Appraising fertilisers: origins of current regulations and standards for contaminants in fertilisers : background of quality standards in the Netherlands, Denmark, Germany, United Kingdom and Flanders

    NARCIS (Netherlands)

    Ehlert, P.A.I.; Posthuma, L.; Römkens, P.F.A.M.; Rietra, R.P.J.J.; Wintersen, A.M.; Wijnen, van H.; Dijk, van T.A.; Schöll, van L.; Groenenberg, J.E.

    2013-01-01

    The standards for contaminants in fertilisers in Denmark, Germany, Flanders, the Netherlands and United Kingdom, are given in the context of the proposals for new European fertiliser legislation. This EU legislation might result in generic limit values for contaminants and input lists of materials,

  13. Liver safety assessment: required data elements and best practices for data collection and standardization in clinical trials.

    Science.gov (United States)

    Avigan, Mark I; Bjornsson, Einar S; Pasanen, Markku; Cooper, Charles; Andrade, Raul J; Watkins, Paul B; Lewis, James H; Merz, Michael

    2014-11-01

    A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and standards for the accurate measurement of DILI risk associated with new therapeutic agents in clinical trials. There was agreement that in order to achieve this goal the systematic acquisition of protocol-specified clinical measures and lab specimens from all study subjects is crucial. In addition, standard DILI terms that address the diverse clinical and pathologic signatures of DILI were considered essential. There was a strong consensus that clinical and lab analyses necessary for the evaluation of cases of acute liver injury should be consistent with the US Food and Drug Administration (FDA) guidance on pre-marketing risk assessment of DILI in clinical trials issued in 2009. A recommendation that liver injury case review and management be guided by clinicians with hepatologic expertise was made. Of note, there was agreement that emerging DILI signals should prompt the systematic collection of candidate pharmacogenomic, proteomic and/or metabonomic biomarkers from all study subjects. The use of emerging standardized clinical terminology, CRFs and graphic tools for data review to enable harmonization across clinical trials was strongly encouraged. Many of the recommendations made in the breakout session are in alignment with those made in the other parallel sessions on methodology to assess clinical liver safety data, causality assessment for suspected DILI, and liver safety assessment in special populations (hepatitis B, C, and oncology trials). Nonetheless, a few outstanding issues remain for future consideration.

  14. Current status and future developments of LC-MS/MS in clinical chemistry for quantification of biogenic amines

    NARCIS (Netherlands)

    de Jong, Wilhelmina H. A.; de Vries, Elisabeth G. E.; Kema, Ido P.

    Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is rapidly gaining ground in special clinical chemistry laboratories. It significantly increases the analytic potential in clinical chemistry, especially in the field of low molecular weight biomarker analysis. This review overviews current

  15. Reporting unit size and measurement uncertainty: current Australian practice in clinical chemistry and haematology.

    Science.gov (United States)

    Hawkins, Robert C; Badrick, Tony

    2015-08-01

    In this study we aimed to compare the reporting unit size used by Australian laboratories for routine chemistry and haematology tests to the unit size used by learned authorities and in standard laboratory textbooks and to the justified unit size based on measurement uncertainty (MU) estimates from quality assurance program data. MU was determined from Royal College of Pathologists of Australasia (RCPA) - Australasian Association of Clinical Biochemists (AACB) and RCPA Haematology Quality Assurance Program survey reports. The reporting unit size implicitly suggested in authoritative textbooks, the RCPA Manual, and the General Serum Chemistry program itself was noted. We also used published data on Australian laboratory practices.The best performing laboratories could justify their chemistry unit size for 55% of analytes while comparable figures for the 50% and 90% laboratories were 14% and 8%, respectively. Reporting unit size was justifiable for all laboratories for red cell count, >50% for haemoglobin but only the top 10% for haematocrit. Few, if any, could justify their mean cell volume (MCV) and mean cell haemoglobin concentration (MCHC) reporting unit sizes.The reporting unit size used by many laboratories is not justified by present analytical performance. Using MU estimates to determine the reporting interval for quantitative laboratory results ensures reporting practices match local analytical performance and recognises the inherent error of the measurement process.

  16. Echocardiographic assessment of the right ventricle in the current era: Application in clinical practice.

    Science.gov (United States)

    Venkatachalam, Sridhar; Wu, Geru; Ahmad, Masood

    2017-08-22

    The right ventricle has unique structural and functional characteristics. It is now well recognized that the so-called forgotten ventricle is a key player in cardiovascular physiology. Furthermore, there is accumulating evidence that demonstrates right ventricular dysfunction as an important marker of morbidity and mortality in several commonly encountered clinical situations such as heart failure, pulmonary hypertension, pulmonary embolism, right ventricular myocardial infarction, and adult congenital heart disease. In contrast to the left ventricle, echocardiographic assessment of right ventricular function is more challenging as volume estimations are not possible without the use of three-dimensional (3D) echocardiography. Guidelines on chamber quantification provide a standardized approach to assessment of the right ventricle. The technique and limitations of each of the parameters for RV size and function need to be fully understood. In this era of multimodality imaging, echocardiography continues to remain a useful tool for the initial assessment and follow-up of patients with right heart pathology. Several novel approaches such as 3D and strain imaging of the right ventricle have expanded the usefulness of this indispensable modality. © 2017, Wiley Periodicals, Inc.

  17. Case Specificity of Standardized-Patient Examinations: Consistency of Performance on Components of Clinical Competence within and between Cases.

    Science.gov (United States)

    Colliver, Jerry A.; And Others

    1990-01-01

    Standardized patient case problems were administered to approximately 280 final year medical students. Results indicate that performance on a given component of clinical competence shows less consistency when measured on different cases than does performance on different components measured on the same case. (TJH)

  18. Assessing the reliability of the borderline regression method as a standard setting procedure for objective structured clinical examination

    Directory of Open Access Journals (Sweden)

    Sara Mortaz Hejri

    2013-01-01

    Full Text Available Background: One of the methods used for standard setting is the borderline regression method (BRM. This study aims to assess the reliability of BRM when the pass-fail standard in an objective structured clinical examination (OSCE was calculated by averaging the BRM standards obtained for each station separately. Materials and Methods: In nine stations of the OSCE with direct observation the examiners gave each student a checklist score and a global score. Using a linear regression model for each station, we calculated the checklist score cut-off on the regression equation for the global scale cut-off set at 2. The OSCE pass-fail standard was defined as the average of all station′s standard. To determine the reliability, the root mean square error (RMSE was calculated. The R2 coefficient and the inter-grade discrimination were calculated to assess the quality of OSCE. Results: The mean total test score was 60.78. The OSCE pass-fail standard and its RMSE were 47.37 and 0.55, respectively. The R2 coefficients ranged from 0.44 to 0.79. The inter-grade discrimination score varied greatly among stations. Conclusion: The RMSE of the standard was very small indicating that BRM is a reliable method of setting standard for OSCE, which has the advantage of providing data for quality assurance.

  19. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the Ambulatory Glucose Profile (AGP).

    Science.gov (United States)

    Bergenstal, Richard M; Ahmann, Andrew J; Bailey, Timothy; Beck, Roy W; Bissen, Joan; Buckingham, Bruce; Deeb, Larry; Dolin, Robert H; Garg, Satish K; Goland, Robin; Hirsch, Irl B; Klonoff, David C; Kruger, Davida F; Matfin, Glenn; Mazze, Roger S; Olson, Beth A; Parkin, Christopher; Peters, Anne; Powers, Margaret A; Rodriguez, Henry; Southerland, Phil; Strock, Ellie S; Tamborlane, William; Wesley, David M

    2013-03-01

    Abstract Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardization of analysis and presentation of glucose monitoring data, with the initial focus on data derived from CGM systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile (AGP), and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings. This paper provides a summary of the topics and issues discussed during the meeting and presents recommendations from the expert panel regarding the need to standardize glucose profile summary metrics and the value of a uniform glucose report to aid clinicians, researchers, and patients.

  20. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the ambulatory glucose profile.

    Science.gov (United States)

    Bergenstal, Richard M; Ahmann, Andrew J; Bailey, Timothy; Beck, Roy W; Bissen, Joan; Buckingham, Bruce; Deeb, Larry; Dolin, Robert H; Garg, Satish K; Goland, Robin; Hirsch, Irl B; Klonoff, David C; Kruger, Davida F; Matfin, Glenn; Mazze, Roger S; Olson, Beth A; Parkin, Christopher; Peters, Anne; Powers, Margaret A; Rodriguez, Henry; Southerland, Phil; Strock, Ellie S; Tamborlane, William; Wesley, David M

    2013-01-01

    Underutilization of glucose data and lack of easy and standardized glucose data collection, analysis, visualization, and guided clinical decision making are key contributors to poor glycemic control among individuals with type 1 diabetes mellitus. An expert panel of diabetes specialists, facilitated by the International Diabetes Center and sponsored by the Helmsley Charitable Trust, met in 2012 to discuss recommendations for standardizing the analysis and presentation of glucose monitoring data, with the initial focus on data derived from continuous glucose monitoring systems. The panel members were introduced to a universal software report, the Ambulatory Glucose Profile, and asked to provide feedback on its content and functionality, both as a research tool and in clinical settings. This article provides a summary of the topics and issues discussed during the meeting and presents recommendations from the expert panel regarding the need to standardize glucose profile summary metrics and the value of a uniform glucose report to aid clinicians, researchers, and patients.

  1. Functions and activities of the Area Committee on Microbiology of the National Committee for Clinical Laboratory Standards.

    Science.gov (United States)

    Washington, J A

    1991-01-01

    The Area Committee on Microbiology of the National Committee for Clinical Laboratory Standards has responsibility for the development of guidelines and standards in the field of clinical microbiology. Through the consensus process, representatives from government, industry, and professional societies have developed standards on antibacterial susceptibility testing (M2, M7, and M11), antimycobacterial susceptibility testing (M24), quality assurance on commercially prepared microbiological culture media (M22), evaluation of production lots of dehydrated Mueller-Hinton agar (M6), and preparation and testing of fetal bovine serum for use as cell culture growth supplement (M25) and guidelines on bactericidal tests (M26), protection of laboratory workers from infections transmitted by blood, body fluids, and tissue (M29), blood film examination for parasites (M15), and development of in vitro susceptibility testing criteria and quality control parameters (M23). PMID:2070343

  2. Current research and clinical trials for a vaccine against Chikungunya virus

    Directory of Open Access Journals (Sweden)

    Singh P

    2013-08-01

    Full Text Available Priyanka Singh,1 Mala Chhabra,1 Veena Mittal,1 Pankaj Sharma,1 Moshahid A Rizvi,2 Lakhvir Singh Chauhan,1 Arvind Rai1 1National Centre for Disease Control, Sham Nath Marg, 2Department of Biosciences, Jamia Millia Islamia, New Delhi, India Abstract: Chikungunya infection is a self-limiting Aedes mosquito-borne arboviral disease with variable clinical manifestations, ranging from asymptomatic illness to a very severe and crippling arthralgia. Until recently, Chikungunya was a little known disease that re-emerged in 2005–2006, leading to major outbreaks on the Indian Ocean Islands and in South East Asia, and eventually extending its range to temperate regions. It drew global attention due to its explosive onset, extensive geographic distribution, and high morbidity. Since re-emergence, an estimated one million symptomatic cases with 0.1% fatality per year have been reported globally. A lack of herd immunity, vector control, and globalization and trade are clearly a problem in the spread of this disease. The Chikungunya virus (CHIKV has also acquired biologically important mutations during its evolution, increasing its geographic reach. This disease has resulted in a loss of productivity in affected communities. The absence of a vaccine or an effective antiviral therapy makes dealing with this disease challenging for those involved in public health. There is an emergent need for an effective vaccine against CHIKV infection. The candidates that have been tested include attenuated living, nonliving and genetically engineered vaccines. Several of these vaccine candidates are in preclinical and clinical trials. This review outlines the current knowledge about chikungunya infection and vaccine development. Keywords: Chikungunya, outbreaks, epidemics, genotypes, vaccines, therapy

  3. The inter-examiner reliability of standardized manual palpation for the identification of clinically relevant myofascial triggerpoints

    DEFF Research Database (Denmark)

    Myburgh, Corrie; Lauridsen, Henrik Hein; Larsen, Anders Holsgaard

    -observer agreement of TP examination among four examiners and whether reproducibility is influenced by examiner clinical experience. Two experienced and two inexperienced clinicians each performed a standardized palpation of the upper Trapezius musculature. Each observer was asked to judge the presents...... in order to improve protocol standardization. Kappa co-efficients were calculated for all possible examiner pairings. Good agreement was noted between the experienced pairing (κ= 0.63). Moderate levels of agreement were observed among the two mixed pairings (κ=0.35 and 0.47 respectively). However, poor......A clinical diagnosis of Myofascial Pain Syndrome (MPS) requires manual palpation for the identification of at least one clinically relevant trigger point (TP). However, few comparable, high quality studies exist regarding the robustness of TP examination. Our aim was to determine the inter...

  4. Deep brain stimulation for Parkinson disease in Australia: current scientific and clinical status.

    Science.gov (United States)

    Poortvliet, P C; Silburn, P A; Coyne, T J; Chenery, H J

    2015-02-01

    There is currently no cure for Parkinson disease (PD). Disease management is directed primarily at motor symptom relief, but the impact of non-motor symptoms associated with PD should not be underestimated. Medical and surgical treatment options aim to increase functional independence and quality of life. Deep brain stimulation (DBS) has proven to be a safe, effective and cost-efficient surgical treatment option. In 2009, the Australian referral guidelines, developed to provide a synopsis of DBS therapy for PD, were introduced, and since then novel findings have been reported regarding the timing of intervention, target selection and symptom management. Our aim is to provide an update of DBS for PD in Australia. Intervention at earlier stages of the disease can potentially improve quality of life over a longer period with greater possibilities for meaningful social and professional contributions. For less responsive motor symptoms (e.g. freezing of gait, postural instability), the pedunculopontine nucleus has emerged as a promising new surgical target. Traditional PD treatment is focused on improvement of motor symptoms, but the disorder is also characterised by non-motor symptoms, often undiagnosed or undisclosed, that have the potential to impact quality of life to a greater extent than motor symptoms. It is essential to identify and routinely monitor for non-motor symptoms as they can emerge at all stages of the disease or can result from treatment. Many of these current advances require long-term monitoring of treatment outcomes to improve future clinical practice, refine patient selection and ensure best patient outcomes.

  5. Using a Standardized Patient Approach to Enhance Clinical Skills in Gerontological Social Work

    Science.gov (United States)

    Emlet, Charles A.

    2010-01-01

    The rapid increase in the number of older adults in the United States, coupled with new accreditation standards based on competencies, requires social workers to show competence in working with older clients. This teaching note reports on the development and use of a standardized patient (SP) role-play to teach and evaluate the ability of graduate…

  6. Design and validation of standardized clinical and functional remission criteria in schizophrenia

    Directory of Open Access Journals (Sweden)

    Mosolov SN

    2014-01-01

    Full Text Available Sergey N Mosolov,1 Andrey V Potapov,1 Uriy V Ushakov,2 Aleksey A Shafarenko,1 Anastasiya B Kostyukova11Department of Mental Disorders Therapy, Moscow Research Institute of Psychiatry, Moscow, Russia; 2Moscow Psychiatric Outpatient Services #21, Moscow, RussiaBackground: International Remission Criteria (IRC for schizophrenia were developed recently by a group of internationally known experts. The IRC detect only 10%–30% of cases and do not cover the diversity of forms and social functioning. Our aim was to design a more applicable tool and validate its use – the Standardized Clinical and Functional Remission Criteria (SCFRC.Methods: We used a 6-month follow-up study of 203 outpatients from two Moscow centers and another further sample of stable patients from a 1-year controlled trial of atypical versus typical medication. Diagnosis was confirmed by International Classification of Diseases Version 10 (ICD10 criteria and the Mini-International Neuropsychiatric Interview (MINI. Patients were assessed by the Positive and Negative Syndrome Scale, including intensity threshold, and further classified using the Russian domestic remission criteria and the level of social and personal functioning, according to the Personal and Social Performance Scale (PSP. The SCFRC were formulated and were validated by a data reanalysis on the first population sample and on a second independent sample (104 patients and in an open-label prospective randomized 12-month comparative study of risperidone long-acting injectable (RLAI versus olanzapine.Results: Only 64 of the 203 outpatients (31.5% initially met the IRC, and 53 patients (26.1% met the IRC after 6 months, without a change in treatment. Patients who were in remission had episodic and progressive deficit (39.6%, or remittent (15% paranoid schizophrenia, or schizoaffective disorder (17%. In addition, 105 patients of 139 (51.7%, who did not meet symptomatic IRC, remained stable within the period. Reanalysis of

  7. A Review of the Multi-Authored Monograph “The Medical (Clinical Psychology Diagnosis: Current State and Prospects”

    Directory of Open Access Journals (Sweden)

    Vachkov I.V.

    2017-06-01

    Full Text Available The monograph presents a number of articles written by leading domestic clinical psychologists on various issues connected with psychological diagnosis. The multi-authored monograph was written for the international research-to-practice conference “The medical (clinical psychology diagnosis: tradition and prospects”. The conference took place in Moscow on November 29-30, 2016. The book consists of the following sections: "Research methodology in clinical psychology", “The development of endogenous mental pathology diagnosis current trends”, “The development of clinical psychology diagnostics current trends: age aspects”, “The main problems of clinical-psychological prevention and rehabilitation”. The materials of the monograph may be interesting and useful for scientists, psychology lecturers, students and post-graduate students, as well as for specialists working in the field of public health, education and social support for the population.

  8. Clinical utility of ulipristal acetate for the treatment of uterine fibroids: current evidence

    Directory of Open Access Journals (Sweden)

    Trefoux Bourdet A

    2015-03-01

    Full Text Available Alice Trefoux Bourdet, Dominique Luton, Martin Koskas Department of Obstetrics and Gynecology, Bichat University Hospital, Paris Diderot University, Paris, France Abstract: Uterine myoma is the most common benign uterine tumor in women of reproductive age and occurs in 20%–25% of the worldwide population. No currently approved medical treatment is able to completely eliminate fibroids. Surgery, particularly hysterectomy, predominates as the treatment strategy of choice, even though it is associated with risks and complications and causes infertility. Until recently, gonadotropin-releasing hormone agonists were the only available drugs for the preoperative treatment of fibroids. However, ulipristal acetate (UPA, an oral selective progesterone receptor modulator, was recently licensed in Europe for the same indication. Recent studies have demonstrated the efficacy and safety of UPA in the medical management of fibroids before surgery, with a better tolerability profile than leuprolide acetate. Analyzing the literature, we identified new management strategies involving UPA and surgery, considering advantages of both medical and surgical therapy. The advent of UPA will undoubtedly modify the surgical approach to fibroids, but the heterogeneity of these possible indications now requires various original clinical studies to identify the optimal indications for UPA in patients with symptomatic fibroid(s. Keywords: uterine fibroids, medical treatment, selective progesterone receptor modulator, ulipristal acetate, surgery

  9. T2* mapping of articular cartilage: current status of research and first clinical applications.

    Science.gov (United States)

    Andreisek, Gustav; Weiger, Markus

    2014-01-01

    T2* mapping is a relatively new method for the compositional assessment of the articular cartilage. Typically, a multigradient echo or an ultrashort echo time imaging technique with a range of short and very short echo times is used. In most studies, imaging is performed at a high field strength, that is, 3 and 7 T. Postprocessing includes exponential fitting of relaxation decay and manual region-of-interest-based measurements of T2* times on T2* maps. Detailed analyses of T2* times of articular cartilage have shown distinct T2* components with shorter and longer T2* times. Moreover, there is a zonal distribution with a significant depthwise gradient of T2*, with relatively short times near the osteochondral junction and relatively long times at the cartilage's surface. T2* times of normal articular cartilage at the knee are, when averaged over the whole cartilage thickness and using monoexponential fitting, approximately 20 milliseconds. The results of recent studies have shown a good test-retest as well as interreader and intrareader reliabilities for T2* mapping. This article provides a descriptive review of the current literature, briefly discusses the technique itself, and provides an outlook on future research questions and possible clinical applications.

  10. PI3K and Akt as molecular targets for cancer therapy: current clinical outcomes

    Institute of Scientific and Technical Information of China (English)

    Ipsita PAL; Mahitosh MANDAL

    2012-01-01

    The PI3K-Akt pathway is a vital regulator of cell proliferation and survival.Alterations in the PIK3CA gene that lead to enhanced PI3K kinase activity have been reported in many human cancer types,including cancers of the colon,breast,brain,liver,stomach and lung.Deregulation of PI3K causes aberrant Akt activity.Therefore targeting this pathway could have implications for cancer treatment.The first generation PI3K-Akt inhibitors were proven to be highly effective with a low IC50,but later,they were shown to have toxic side effects and poor pharmacological properties and selectivity.Thus,these inhibitors were only effective in preclinical models.However,derivatives of these first generation inhibitors are much more selective and are quite effective in targeting the PI3K-Akt pathway,either alone or in combination.These second-generation inhibitors are essentially a specific chemical moiety that helps to form a strong hydrogen bond interaction with the PI3K/Akt molecule.The goal of this review is to delineate the current efforts that have been undertaken to inhibit the various components of the PI3K and Akt pathway in different types of cancer both in vitro and in vivo.Our focus here is on these novel therapies and their inhibitory effects that depend upon their chemical nature,as well as their development towards clinical trials.

  11. [Monogenic obesity - current status of molecular genetic research and clinical importance].

    Science.gov (United States)

    Aldhoon-Hainerová, Irena; Včelák, Josef; Zamrazilová, Hana

    2014-01-01

    Obesity and its comorbidities represent one of the major health problems worldwide. A positive energy balance due to inappropriate life-style changes plays a key role in the current obesity epidemic. The influence of genetic factors is also significant - several studies concluded that genes contribute to the development of obesity by 40-70%. Genetic variability predisposes an individual to tendency or resistance to increase body weight in obesogenic environment. Polygenic type of inheritance is responsible in most of obese individuals. However, an intensive research of the past 20 years has led to an identification of several genes causing monogenic forms of obesity. To date, several monogenic genes (leptin, leptin receptor, prohormon convertase 1, proopiomelanocortin, melanocortin 4 receptor, single-minded homolog 1, brain-derived neurotrophic factor, neurotrophic tyrosine kinase receptor type 2) that are either involved in the neuronal differentiation of the paraventricular nucleus or in the leptin-melanocortin pathway are known to cause obesity. Mutation carriers apart from severe early onset obesity manifest with additional phenotypic characteristics as adrenal insufficiency, impaired immunity and impaired fertility. This review provides an overview of molecular-genetic and clinical research in the field of monogenic obesities including therapeutical approaches.

  12. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations

    Directory of Open Access Journals (Sweden)

    Brad B Swelstad

    2009-12-01

    Full Text Available Brad B Swelstad, Candace L KerrInstitute for Cell Engineering, Department of Obstetrics and Gynecology, Johns Hopkins University, Baltimore, MA, USAAbstract: Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs and parthenogenic ESCs (pESCs are derived from the embryo proper while embryonic germ cells (EGCs, embryonal carcinoma cells (ECCs, and germ-line stem cells (GSC are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs, have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.Keywords: pluripotency, stem cells, derivation, human

  13. Current protocols in the generation of pluripotent stem cells: theoretical, methodological and clinical considerations.

    Science.gov (United States)

    Swelstad, Brad B; Kerr, Candace L

    2009-12-22

    Pluripotent stem cells have been derived from various embryonic, fetal and adult sources. Embryonic stem cells (ESCs) and parthenogenic ESCs (pESCs) are derived from the embryo proper while embryonic germ cells (EGCs), embryonal carcinoma cells (ECCs), and germ-line stem cells (GSC) are produced from germ cells. ECCs were the first pluripotent stem cell lines established from adult testicular tumors while EGCs are generated in vitro from primordial germ cells (PGCs) isolated in late embryonic development. More recently, studies have also demonstrated the ability to produce GSCs from adult germ cells, known as spermatogonial stem cells. Unlike ECCs, the source of GSCs are normal, non-cancerous adult tissue. The study of these unique cell lines has provided information that has led to the ability to reprogram somatic cells into an ESC-like state. These cells, called induced pluripotent stem cells (iPSCs), have been derived from a number of human fetal and adult origins. With the promises pluripotent stem cells bring to cell-based therapies there remain several considerations that need to be carefully studied prior to their clinical use. Many of these issues involve understanding key factors regulating their generation, including those which define pluripotency. In this regard, the following article discusses critical aspects of pluripotent stem cell derivation and current issues about their therapeutic potential.

  14. Ultrasound Current Source Density Imaging in live rabbit hearts using clinical intracardiac catheter

    Science.gov (United States)

    Li, Qian

    Ultrasound Current Source Density Imaging (UCSDI) is a noninvasive modality for mapping electrical activities in the body (brain and heart) in 4-dimensions (space + time). Conventional cardiac mapping technologies for guiding the radiofrequency ablation procedure for treatment of cardiac arrhythmias have certain limitations. UCSDI can potentially overcome these limitations and enhance the electrophysiology mapping of the heart. UCSDI exploits the acoustoelectric (AE) effect, an interaction between ultrasound pressure and electrical resistivity. When an ultrasound beam intersects a current path in a material, the local resistivity of the material is modulated by the ultrasonic pressure, and a change in voltage signal can be detected based on Ohm's Law. The degree of modulation is determined by the AE interaction constant K. K is a fundamental property of any type of material, and directly affects the amplitude of the AE signal detected in UCSDI. UCSDI requires detecting a small AE signal associated with electrocardiogram. So sensitivity becomes a major challenge for transferring UCSDI to the clinic. This dissertation will determine the limits of sensitivity and resolution for UCSDI, balancing the tradeoff between them by finding the optimal parameters for electrical cardiac mapping, and finally test the optimized system in a realistic setting. This work begins by describing a technique for measuring K, the AE interaction constant, in ionic solution and biological tissue, and reporting the value of K in excised rabbit cardiac tissue for the first time. K was found to be strongly dependent on concentration for the divalent salt CuSO4, but not for the monovalent salt NaCl, consistent with their different chemical properties. In the rabbit heart tissue, K was determined to be 0.041 +/- 0.012 %/MPa, similar to the measurement of K in physiologic saline: 0.034 +/- 0.003 %/MPa. Next, this dissertation investigates the sensitivity limit of UCSDI by quantifying the relation

  15. The effectiveness of using standardized patients to improve community physician skills in mammography counseling and clinical breast exam.

    Science.gov (United States)

    Costanza, M E; Luckmann, R; Quirk, M E; Clemow, L; White, M J; Stoddard, A M

    1999-10-01

    Traditional didactic continuing education is relatively ineffective in improving physicians' clinical skills. We hypothesized that a centralized course including small group workshops utilizing standardized patients could improve clinical skills for a reasonable cost. We designed a 5-h course aimed at improving physicians' counseling skills (re: screening mammography) and clinical breast exam (CBE) skills. The course included lectures, demonstrations, and small group skills sessions utilizing standardized patients and was offered to 156 typical community-based primary care physicians. Pre- and postcourse evaluation included in-office assessments of physician CBE and counseling performance by standardized patients and a written test of knowledge and attitudes. A total of 54.5% of eligible physicians participated. They improved modestly in only one of three areas of counseling skills measured (providing counseling appropriate to the patient's readiness to accept mammography, P = 0.01). The overall CBE score increased substantially from 24.8 to 34.7 (P < 0.0001). Knowledge in all areas measured and confidence in counseling patients also increased. The basic course cost $202 per physician trained. Most community-based primary care physicians may find small group training and in-office evaluation involving standardized patients acceptable. Such training may be more effective in improving physical exam skills than complex communication skills.

  16. 物流标准化发展现状研究综述%The Research Review of the Current Situation of the Development of Logistics Standardization

    Institute of Scientific and Technical Information of China (English)

    柳飞; 武赟; 戴铭卿

    2015-01-01

    The thesis reviews current situation of the development of logistics standardization systematically. It summarizes the general research contents from the four aspects: logistics standardization and management system, establishment of the standardization of logistics, implementation of the standardization of logistics and performance evaluation of the standardization.Moreover, the authors put forward with their own view.%本文系统回顾了有关物流标准化发展现状.分别从物流标准化和管理体制、物流标准化的建立、物流标准化的贯彻实施以及物流标准化的绩效评价四个方面进行综述,提出本文观点.

  17. The World Health Organization child growth standards: expected implications for clinical and epidemiological research.

    Science.gov (United States)

    Van den Broeck, J; Willie, D; Younger, N

    2009-02-01

    In 2006 and 2007, the World Health Organization (WHO) released two sets of child growth standards (World Health Organization, WHO Child Growth Standards. Methods and development. Length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age. WHO, Geneva, 2006; World Health Organization, WHO Child Growth Standards: Methods and Development. Head circumference-for-age, arm circumference-for-age, triceps skinfold-for-age and subscapular skinfold-for-age. WHO, Geneva, 2007) to replace the National Center for Health Statistics references (Hamill et al., National Center for Health Statistics, Vital and Health Statistics Series 11, No 165, 1977) as an international tool for growth and nutritional assessment. This paper explores the scope of implications for future anthropometric research, highlighting foreseeable effects on the choice of research questions, choice of nutritional indices, training of measurers, and issues of internal and external validity of research results. The conclusion drawn is that the introduction of the WHO child growth standards is expected to have wide implications for growth and nutrition research. The full scope of this effect will gradually become clear while researchers, similar to health care workers, make the transition to using the new standards, re-evaluate results of past approaches, and explore the uses and functional validity of the standards, including those for indices that were not previously available.

  18. Low-dose versus standard-dose CT protocol in patients with clinically suspected renal colic.

    Science.gov (United States)

    Poletti, Pierre-Alexandre; Platon, Alexandra; Rutschmann, Olivier T; Schmidlin, Franz R; Iselin, Christophe E; Becker, Christoph D

    2007-04-01

    The purpose of our study was to compare a low-dose abdominal CT protocol, delivering a dose of radiation close to the dose delivered by abdominal radiography, with standard-dose unenhanced CT in patients with suspected renal colic. One hundred twenty-five patients (87 men, 38 women; mean age, 45 years) who were admitted with suspected renal colic underwent both abdominal low-dose CT (30 mAs) and standard-dose CT (180 mAs). Low-dose CT and standard-dose CT were independently reviewed, in a delayed fashion, by two radiologists for the characterization of renal and ureteral calculi (location, size) and for indirect signs of renal colic (renal enlargement, pyeloureteral dilatation, periureteral or renal stranding). Results reported for low-dose CT, with regard to the patients' body mass indexes (BMIs), were compared with those obtained with standard-dose CT (reference standard). The presence of non-urinary tract-related disorders was also assessed. Informed consent was obtained from all patients. In patients with a BMI 3 mm. Low-dose CT was 100% sensitive and specific for depicting non-urinary tract-related disorders (n = 6). Low-dose CT achieves sensitivities and specificities close to those of standard-dose CT in assessing the diagnosis of renal colic, depicting ureteral calculi > 3 mm in patients with a BMI < 30, and correctly identifying alternative diagnoses.

  19. Current and Future Clinical Applications of Zinc Transporter-8 in Type 1 Diabetes Mellitus

    Directory of Open Access Journals (Sweden)

    Bo Yi

    2015-01-01

    Conclusions: ZnT8 is a novel islet autoantigen with a widely potential for clinical applications in T1DM. However, before the large-scale clinical applications, there are still many problems to be solved.

  20. Vincristine pharmacokinetics is related to clinical outcome in children with standard risk acute lymphoblastic leukemia

    NARCIS (Netherlands)

    Loennerholm, Gudmar; Frost, Britt-Marie; Abrahamsson, Jonas; Behrendtz, Mikael; Castor, Anders; Forestier, Erik; Heyman, Mats; Uges, Donald R. A.; de Graaf, Siebold S. N.

    2008-01-01

    Vincristine is a key drug in the treatment of childhood and adult acute lymphoblastic leukemia (ALL), and many other childhood malignancies. Despite decades of wide clinical use, no data on the correlation between vincristine pharmacokinetics and long-term clinical outcome have been published. We he

  1. Consensus recommendations for a standardized Brain Tumor Imaging Protocol in clinical trials

    NARCIS (Netherlands)

    B.M. Ellingson (Benjamin M.); M. Bendszus (Martin); J. Boxerman (Jerrold); D. Barboriak (Daniel); B.J. Erickson (Bradley J.); M. Smits (Marion); S.J. Nelson (Sarah J.); E. Gerstner (Elizabeth); B. Alexander (Brian); G. Goldmacher (Gregory); W. Wick (Wolfgang); M.A. Vogelbaum (Michael); M. Weller (Michael); E. Galanis (Evanthia); J. Kalpathy-Cramer (Jayashree); L. Shankar; P. Jacobs (Paula); W.B. Pope (Whitney B.); D. Yang (Dewen); C. Chung (Caroline); R.H. Knopp; S. Cha (Soonme); M.J. van den Bent (Martin); S.M. Chang (Susan); W.K. Al Yung; T.F. Cloughesy (Timothy F.); P.Y. Wen (Patrick Y.); M.R. Gilbert (Mark R.); A. Whitney (Andrew); D. Sandak (David); A. Musella (Al); C. Haynes (Chas); M. Wallace (Max); D.F. Arons (David F.); A. Kingston (Ann)

    2015-01-01

    textabstractA recent joint meeting was held on January 30, 2014, with the US Food and Drug Administration (FDA), National Cancer Institute (NCI), clinical scientists, imaging experts, pharmaceutical and biotech companies, clinical trials cooperative groups, and patient advocate groups to discuss ima

  2. Lung scintigraphy in the diagnosis of pulmonary embolism: current methods and interpretation criteria in clinical practice.

    Science.gov (United States)

    Skarlovnik, Ajda; Hrastnik, Damjana; Fettich, Jure; Grmek, Marko

    2014-06-01

    In current clinical practice lung scintigraphy is mainly used to exclude pulmonary embolism (PE). Modified diagnostic criteria for planar lung scintigraphy are considered, as newer scitigraphic methods, especially single photon emission computed tomography (SPECT) are becoming more popular. Data of 98 outpatients who underwent planar ventilation/perfusion (V/Q) scintigraphy and 49 outpatients who underwent V/Q SPECT from the emergency department (ED) were retrospectively collected. Planar V/Q images were interpreted according to 0.5 segment mismatch criteria and revised PIOPED II criteria and perfusion scans according to PISA-PED criteria. V/Q SPECT images were interpreted according to the criteria suggested in EANM guidelines. Final diagnosis of PE was based on the clinical decision of an attending physician and evaluation of a 12 months follow-up period. Using 0.5 segment mismatch criteria and revised PIOPED II, planar V/Q scans were diagnostic in 93% and 84% of cases, respectively. Among the diagnostic planar scans readings specificity for 0.5 segment mismatch criteria was 98%, and 99% for revised PIOPED II criteria. V/Q SPECT showed a sensitivity of 100% and a specificity of 98%, without any non-diagnostic cases. In patients with low pretest probability for PE, planar V/Q scans assessed by 0.5 segment mismatch criteria were diagnostic in 92%, and in 85% using revised PIOPED II criteria, while perfusion scintigraphy without ventilation scans was diagnostic in 80%. Lung scintigraphy yielded diagnostically definitive results and is reliable in ruling out PE in patients from ED. V/Q SPECT has excellent specificity and sensitivity without any non-diagnostic results. Percentage of non-diagnostic results in planar lung scintigraphy is considerably smaller when 0.5 segment mismatch criteria instead of revised PIOPED II criteria are used. Diagnostic value of perfusion scintigraphy according to PISA-PED criteria is inferior to combined V/Q scintigraphy; the difference is

  3. Standardized manual palpation of myofascial trigger points in relation to neck/shoulder pain; the influence of clinical experience on inter-examiner reproducibility.

    Science.gov (United States)

    Myburgh, Corrie; Lauridsen, Henrik Hein; Larsen, Anders H; Hartvigsen, Jan

    2011-04-01

    A diagnosis of Myofascial Pain Syndrome (MPS) requires palpation for the identification of at least one clinically relevant trigger point (TP). However, few comparable, high quality studies currently exist from which to draw firm conclusions regarding the robustness of TP examination. An inter-observer agreement study was conducted using two experienced and two inexperienced clinicians. All performed standardized palpation of the upper Trapezius musculature, judging the clinical relevance of TP(s) using clinician global assessment (GA). A random case mix of 81 female participants was examined, 14 asymptomatic and the remainder suffering from neck/shoulder pain. Examiners received psychomotor skills training and video feedback analysis to improve protocol standardization. Kappa co-efficient calculations indicated good agreement between the experienced pairing (κ = 0.63), moderate agreement between the mixed pairings (κ = 0.35 and 0.47) and poor agreement between the inexperienced pairing (κ = 0.22). Inter-observer agreement was not stable with the experienced pairing exhibiting a sharp decline in agreement during the latter portion of the study. Identification of clinically relevant TPs of the upper Trapezius musculature is reproducible when performed by two experienced clinicians, however, a mixed observer pairing can yield acceptable agreement. A protracted period of data collection may be detrimental to inter-observer agreement; more investigation is needed in this regard.

  4. Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

    Science.gov (United States)

    Dreischulte, Tobias; Fernandez-Llimos, Fernando

    2016-12-01

    Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (Pharmaceutical care also encompassed certain professional activities, constituted a scientific discipline and targeted cost effectiveness. The proportions of participants willing to accept legal responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20.3%/44.0%). Conclusions The survey identified key disagreements around the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care', which future discussions around a harmonised definition of 'Clinical Pharmacy' should aim to resolve. Further research is required to understand barriers and facilitators to pharmacists

  5. Reliability of clinical diagnosis and laboratory testing techniques currently used for identification of canine parvovirus enteritis in clinical settings

    Science.gov (United States)

    FAZ, Mirna; MARTÍNEZ, José Simón; QUIJANO-HERNÁNDEZ, Israel; FAJARDO, Raúl

    2016-01-01

    Canine parvovirus type 2 (CPV-2) is the main etiological agent of viral enteritis in dogs. Actually in literature, CPV-2 has been reported with clinical signs that vary from the classical disease, and immunochromatography test and PCR technique have been introduced to veterinary hospitals to confirm CPV-2 diagnosis and other infections. However, the reliability of these techniques has been poorly analyzed. In this study, we evaluated the sensitivity and specificity of veterinary clinical diagnosis, immunochromatography test and PCR technique. Our data indicate that variations in the clinical signs of CPV-2 complicate the gathering of an appropriate diagnosis; and immunochromatography test and PCR technique do not have adequate sensitivity to diagnose positive cases. PMID:27818461

  6. [Standardization of measurement of catalytic activity concentration of enzymes--current situation regarding the external quality assessment program provided by the Japan Medical Association].

    Science.gov (United States)

    Maekawa, Masato

    2010-01-01

    Measurement of the catalytic activity concentration of enzymes has been standardized using a traceability chain, consisting a reference measurement system for enzyme catalytic activity and reference standard-JSCC enzyme. The Japan Medical Association (JMA) has provided an external quality assessment (EQA) survey program for clinical laboratory testing. More than 3,100 clinical laboratories participated in 2008. The EQA program indicated that standardization of the measurement of the catalytic activity concentration of enzymes has been completed for AST, ALT, LD, ALP, gammaGT, and CK in more than 90% laboratories, and for Amy and ChE in nearly 80% of laboratories. Because such a large survey program must use artificial specimens, a matrix effect cannot be avoided, especially in dry chemistry. However, the bias produced by a matrix effect usually has a predictable tendency: it can be corrected. Next, after standardization of the measurement of the catalytic activity concentration of enzymes, we should develop and use common reference intervals. On completing the standardization, we can make standard medical decisions using reference measurement systems and rules.

  7. [Ambulatory esophageal pH monitoring: critical review of methodology: (equipment, reproducibility, standards), clinical importance and personal experience].

    Science.gov (United States)

    Jonard, P; Fiasse, R; Tomé, G; Dive, C

    1990-01-01

    The authors review the recent literature about the methodology of oesophageal pH monitoring, which has a high sensitivity and a high specificity for assessing gastro-oesophageal reflux. Combined electrodes offer most advantages. Ambulatory recording should be done in hospital under standard conditions (meals), particularly for clinical studies. The best clinical indication is to detect pathological reflux in case of atypical symptoms with negative oesophagoscopy. The authors give their normal values in a series of measurements with two systems as well as their results in a series of cases of oesophagitis of various grades.

  8. Projection of bootstrap current in the ITER with standard type I ELMy H-mode and steady state scenarios

    Directory of Open Access Journals (Sweden)

    Thawatchai Onjun

    2012-02-01

    Full Text Available The investigation of bootstrap current formation in ITER is carried out using BALDUR integrated predictive modelingcode. The combination of Mixed B/gB anomalous transport model and NLCASS module together with the pedestal model isused in BALDUR code to simulate the time evolution of temperature, density, and plasma current profiles. It was found inthe simulations that without the presence of ITB, a minimal fraction of bootstrap current (as well as low fusion performancewas achieved. The enhancement due to ITB depends sensitively on the strength of toroidal velocity. A sensitivity study wasalso carried out to optimize the bootstrap current fraction and plasma performance. It was found that the bootstrap currentfraction slightly improved; while the plasma performance greatly improved with increasing of NBI power or pedestal temperature.On the other hand, higher impurity concentration resulted in a significant degradation of fusion performance, buta smaller degradation in bootstrap current.

  9. Establishment of the European College of Veterinary Clinical Pathology (ECVCP) and the current status of veterinary clinical pathology in Europe

    DEFF Research Database (Denmark)

    O'Brien, P.J.; Fournel-Fleury, C.; Bolliger, Adrian Marc

    2007-01-01

    After 5 years of development, the European College of Veterinary Clinical Pathology (ECVCP)was formally recognized and approved on July 4, 2007 by the European Board of Veterinary Specialisation (EBVS), the European regulatory body that oversees specialization in veterinary medicine and which has...

  10. Development of a standardized protocol for reproducible generation of matured monocyte-derived dendritic cells suitable for clinical application

    OpenAIRE

    Bohnenkamp, H.R.; Noll, T.

    2003-01-01

    There is increasing interest in the generation of dendritic cells (DC) for cancer immunotherapy. In order to utilize DC in clinical trials it is necessary to have standardized, reproducible and easy to use protocols. We describe here the process development for the generation of DC as the result of investigation of culture conditions as well as consumption rates of medium and cytokines. Our studies demonstrate that highly viable DC (93 ± 2%) can be produced from CD14+ enriched monocytes via i...

  11. Using Semantic Web technologies for the generation of domain-specific templates to support clinical study metadata standards.

    Science.gov (United States)

    Jiang, Guoqian; Evans, Julie; Endle, Cory M; Solbrig, Harold R; Chute, Christopher G

    2016-01-01

    The Biomedical Research Integrated Domain Group (BRIDG) model is a formal domain analysis model for protocol-driven biomedical research, and serves as a semantic foundation for application and message development in the standards developing organizations (SDOs). The increasing sophistication and complexity of the BRIDG model requires new approaches to the management and utilization of the underlying semantics to harmonize domain-specific standards. The objective of this study is to develop and evaluate a Semantic Web-based approach that integrates the BRIDG model with ISO 21090 data types to generate domain-specific templates to support clinical study metadata standards development. We developed a template generation and visualization system based on an open source Resource Description Framework (RDF) store backend, a SmartGWT-based web user interface, and a "mind map" based tool for the visualization of generated domain-specific templates. We also developed a RESTful Web Service informed by the Clinical Information Modeling Initiative (CIMI) reference model for access to the generated domain-specific templates. A preliminary usability study is performed and all reviewers (n = 3) had very positive responses for the evaluation questions in terms of the usability and the capability of meeting the system requirements (with the average score of 4.6). Semantic Web technologies provide a scalable infrastructure and have great potential to enable computable semantic interoperability of models in the intersection of health care and clinical research.

  12. [Recommendations for implementing the UNE-EN-ISO 15189 quality standard in the clinical microbiology laboratory: bacteriology and serology].

    Science.gov (United States)

    Rojo, María Dolores; Aguiar, Juan Manuel; Cercenado, Emilia; de Ory, Fernando; de la Rosa, Manuel

    2010-11-01

    The UNE-EN-ISO 15189:2007 standard specifies the management and technical requirements that clinical microbiology laboratories must meet to achieve optimal quality when performing microbiological analyses. With implementation of this standard, a laboratory can receive the accreditation and formal recognition of an authorized body, certifying that it is apt for performing an assay or group of assays. In Spain, laboratories that apply these standards can be accredited by the Entidad Nacional de Acreditación (ENAC, Spanish accreditation body). The purpose of this review is to familiarize clinical microbiology laboratory specialists with the UNE-EN-ISO 15189:2007 standard through a practical approach focussed on bacteriology and serology studies. We briefly define the scope and specify the requisites required for managing the quality of the procedures and processes involved in performing tests on human specimens, for document control, and for management of instruments and equipment, personnel, information systems, supply systems, and external services. Lastly, evaluation approaches are indicated to achieve continuing improvement of the processes carried out and the services the laboratory provides.

  13. Development of a document management system for the standardization of clinical laboratory documents.

    Science.gov (United States)

    Hwang, Sang-Hyun; Jung, Seon-Kyung; Kang, Soo-Jin; Cha, Hyo Soung; Chung, Seung Hyun; Lee, Do-Hoon

    2013-11-01

    Documentation is very important; a considerable number of documents exist for use in accreditation inspection. However, most laboratories do not effectively manage the processes of documentation, organization, and storage. The purpose of this study was to facilitate the establishment of a strategically effective and sustainably standardized document management system. A document code formatting system was modified by comparing the document list data received from 3 major university hospitals. In addition, a questionnaire regarding document code standardization was created and sent to 268 institutes to establish document classifications and generate a standard coding scheme. A computerized document management system was developed. Only 32% (8 out of 25 institutes) answered that they were able to identify all of the document types and their numbers. In total, 76% of institutes (19 out of 25) answered that a systematic document management system was necessary. Disorganized document files were systemized by classifying them into 8 major groups according to their characteristics: patient test records (T), test quality control (Q), manuals (M), equipment and environment management (E), statistics (S), division administration (A), department administration (R), and others (X). Our documentation system may serve as a basis for the standardization of documents and the creation of a document management system for all hospital laboratories.

  14. What do standard radiography and clinical examination tell about the shoulder with cuff tear arthropathy?

    Directory of Open Access Journals (Sweden)

    Favard Luc

    2011-01-01

    Full Text Available Abstract Background This study evaluates the preoperative conventional anteroposterior radiography and clinical testing in non-operated patients with cuff tear arthropathy. It analyses the radiological findings in relation to the status of the rotator cuff and clinical status as also the clinical testing in relation to the rotator cuff quality. The aim of the study is to define the usefulness of radiography and clinical examination in cuff tear arthropathy. Methods This study analyses the preoperative radiological (AP-view, (Artro-CT-scan or MRI-scan and clinical characteristics (Constant-Murley-score plus active and passive mobility testing and the peroperative findings in a cohort of 307 patients. These patients were part of a multicenter, retrospective, consecutive study of the French Orthopaedic Society (SOFCOT-2006. All patients had no surgical antecedents and were all treated with prosthetic shoulder surgery for a painful irreparable cuff tear arthropathy (reverse-(84% or hemi-(8% or double cup-bipolar prosthesis (8%. Results A positive significancy could be found for the relationship between clinical testing and the rotator cuff quality; between acromiohumeral distance and posterior rotator cuff quality; between femoralization and posterior rotator cuff quality. Conclusion A conventional antero-posterior radiograph can not provide any predictive information on the clinical status of the patient. The subscapular muscle can be well tested by the press belly test and the teres minor muscle can be well tested by the hornblower' sign and by the exorotation lag signs. The upward migration index and the presence of femoralization are good indicators for the evaluation of the posterior rotator cuff. An inferior coracoid tip positioning suggests rotator cuff disease.

  15. Current Situation and Evaluation of Clinical Studies on Acupuncture and Moxibustion Treatment of Peripheral Facial Paralysis at Selected Stages

    Institute of Scientific and Technical Information of China (English)

    LI Ying; WU Xi; HU Ka-ming; CHEN Xiao-qin

    2010-01-01

    @@ Peripheral facial paralysis is a frequently encountered disease with a high incidence, and it is one of the most common diseases in acupuncture and moxibustion treatment. Because there are rich literatures in clinical studies on acupuncture and moxibustion treatment for this disease, and clinically, it is divided into different stages, in the present paper the current situation of clinical studies about acupuncture and moxibustion treatment for peripheral facial paralysis according to different stages in resent years are analyzed and evaluated including the stage division,the optimal time for treatment, location of injured nerves and assessment of the therapeutic effect, etc.

  16. 75 FR 75485 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-12-03

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first... section 503 of Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs...

  17. 75 FR 62842 - Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for...

    Science.gov (United States)

    2010-10-13

    ... Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies AGENCY: Substance... Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first... section 503 of Public Law 100-71. The ``Mandatory Guidelines for Federal Workplace Drug Testing Programs...

  18. Statistical Association: Alignment of Current U.S. High School Textbooks with the Common Core State Standards for Mathematics

    Science.gov (United States)

    Tran, Dung

    2016-01-01

    This study examined the alignment of three selected U.S. high school textbooks series with the Common Core State Standards for Mathematics (CCSSM) regarding the treatment of statistical association. A framework grounded in the literature for inclusion and exclusion of reasoning about association topics was developed, and textbook entries were…

  19. Dietary Intakes and Eating Habits of College Athletes: Are Female College Athletes Following the Current Sports Nutrition Standards?

    Science.gov (United States)

    Shriver, Lenka H.; Betts, Nancy M.; Wollenberg, Gena

    2013-01-01

    Objective: The objective of this study was to assess dietary intakes and eating habits of female college athletes and compared them with the minimum sports nutrition standards. Participants: Data were obtained from 52 female college athletes from a National Collegiate Athletic Association (NCAA) Division I university between January 2009 and May…

  20. Dietary Intakes and Eating Habits of College Athletes: Are Female College Athletes Following the Current Sports Nutrition Standards?

    Science.gov (United States)

    Shriver, Lenka H.; Betts, Nancy M.; Wollenberg, Gena

    2013-01-01

    Objective: The objective of this study was to assess dietary intakes and eating habits of female college athletes and compared them with the minimum sports nutrition standards. Participants: Data were obtained from 52 female college athletes from a National Collegiate Athletic Association (NCAA) Division I university between January 2009 and May…

  1. Assessing and Addressing the "Testing Backlash": Practical Advice and Current Public Opinion Research for Business Coalitions and Standards Advocates.

    Science.gov (United States)

    Business Roundtable, Washington, DC.

    As states and communities across the United States work to raise expectations for student learning, many are challenged by concerns and questions from increasingly vocal parents and teachers. This report summarizes the best advice for business coalitions and standards advocates on how to address the testing backlash. It also features an analysis…

  2. Comparison of the gold standard of hemoglobin measurement with the clinical standard (BGA) and noninvasive hemoglobin measurement (SpHb) in small children: a prospective diagnostic observational study.

    Science.gov (United States)

    Wittenmeier, Eva; Bellosevich, Sophia; Mauff, Susanne; Schmidtmann, Irene; Eli, Michael; Pestel, Gunther; Noppens, Ruediger R

    2015-10-01

    Collecting a blood sample is usually necessary to measure hemoglobin levels in children. Especially in small children, noninvasively measuring the hemoglobin level could be extraordinarily helpful, but its precision and accuracy in the clinical environment remain unclear. In this study, noninvasive hemoglobin measurement and blood gas analysis were compared to hemoglobin measurement in a clinical laboratory. In 60 healthy preoperative children (0.2-7.6 years old), hemoglobin was measured using a noninvasive method (SpHb; Radical-7 Pulse Co-Oximeter), a blood gas analyzer (clinical standard, BGAHb; ABL 800 Flex), and a laboratory hematology analyzer (reference method, labHb; Siemens Advia). Agreement between the results was assessed by Bland-Altman analysis and by determining the percentage of outliers. Sixty SpHb measurements, 60 labHb measurements, and 59 BGAHb measurements were evaluated. In 38% of the children, the location of the SpHb sensor had to be changed more than twice for the signal quality to be sufficient. The bias/limits of agreement between SpHb and labHb were -0.65/-3.4 to 2.1 g·dl(-1) . Forty-four percent of the SpHb values differed from the reference value by more than 1 g·dl(-1) . Age, difficulty of measurement, and the perfusion index (PI) had no influence on the accuracy of SpHb. The bias/limits of agreement between BGAHb and labHb were 1.14/-1.6 to 3.9 g·dl(-1) . Furthermore, 66% of the BGAHb values differed from the reference values by more than 1 g·dl(-1) . The absolute mean difference between SpHb and labHb (1.1 g·dl(-1) ) was smaller than the absolute mean difference between BGAHb and labHb (1.5 g·dl(-1) /P = 0.024). Noninvasive measurement of hemoglobin agrees more with the reference method than the measurement of hemoglobin using a blood gas analyzer. However, both methods can show clinically relevant differences from the reference method (ClinicalTrials.gov: NCT01693016). © 2015 John Wiley & Sons Ltd.

  3. A confirmatory factor analysis of the WAIS-III in a clinical sample with crossvalidation in the standardization sample.

    Science.gov (United States)

    Burton, D Bradley; Ryan, Joseph J; Axelrod, Bradley N; Schellenberger, Tony

    2002-05-01

    A maximum likelihood confirmatory factor analysis of the Wechsler Adult Intelligence Scale-III (WAIS-III) was performed by applying LISREL 8 to a clinical sample (n=328). Analyses were designed to determine which of the nine hypothesized oblique factor solutions could best explain intelligence as measured by the WAIS-III in the general clinical sample. Competing latent variable models were identified in previous studies and a priori model modifications were made to test derivations of the nine base models. Results in the clinical sample were crossvalidated by testing all models in the normative sample used in the standardization of the scale. Findings in both the clinical and standardization samples supported a six-factor model including Semantic Memory, Verbal Reasoning, Constructional Praxis, Visual Reasoning, Working Memory, and Processing Speed factors. Our analysis differed from that presented in the WAIS-III manual as we tested more complex models of intelligence in addition to the ones evaluated by the test publishers. As a result, a six-factor model that corresponded to an expanded version of a model based on Horn's Gf-Gc theory was empirically supported as having the best fit to the data. More complex derivations of this model failed to achieve sufficient goodness of fit.

  4. A confirmatory factor analysis of the WMS-III in a clinical sample with crossvalidation in the standardization sample.

    Science.gov (United States)

    Bradley Burton, D; Ryan, Joseph J; Axelrod, Bradley N; Schellenberger, Tony; Richards, Heather M

    2003-08-01

    A maximum likelihood confirmatory factor analysis (CFA) of the Wechsler Memory Scale-III (WMS-III) was performed by applying LISREL 8 to a general clinical sample (n=281). Analyses were designed to determine which of seven hypothesized oblique factor solutions could best explain memory as measured by the WMS-III. Competing latent variable models were identified in previous studies. Results in the clinical sample were crossvalidated by testing all models in the WMS-III standardization samples (combined n=1,250). Findings in both the clinical and standardization samples supported a four-factor model containing auditory memory, visual memory, working memory, and learning factors. Our analysis differed from that presented in the WMS-III manual and by other authors. We tested our models in a clinical sample and included selected word list subtests in order to test the viability of a learning dimension. Consistent with prior research, we were also unable to empirically support the viability of the immediate and delayed memory indices, despite allowing the error terms between the immediate and delayed memory subtests to correlate.

  5. Agreement in the diagnosis of dental fluorosis in central incisors performed by a standardized photographic method and clinical examination.

    Science.gov (United States)

    Martins, Carolina Castro; Chalub, Loliza; Lima-Arsati, Ynara Bosco; Pordeus, Isabela Almeida; Paiva, Saul Martins

    2009-05-01

    The aim of this study was to assess agreement in the diagnosis of dental fluorosis performed by a standardized digital photographic method and a clinical examination (gold standard). 49 children (aged 7-9 years) were clinically evaluated by a trained examiner for the assessment of dental fluorosis. Central incisors were evaluated for the presence or absence of dental fluorosis and were photographed with a digital camera. Photographs were presented to three pediatric dentists, who examined the images. Data were analyzed using Cohen's kappa and validity values. Agreement in the diagnosis performed by the photographic method and clinical examination was good (0.67) and accuracy was 83.7%. The prevalence of dental fluorosis was reported to be higher in the clinical examination (49%) compared with the photographic method (36.7%). The photographic method presented higher specificity (96%) than sensitivity (70.8%), a positive predictive value (PPV) of 94.4% and a negative predictive value (NPV) of 77.4%. The diagnosis of dental fluorosis performed using the photographic method presented high specificity and PPV, which indicates that the method is reproducible and reliable for recording dental fluorosis.

  6. Traceable working standards with SI units of radiance for characterizing the measurement performance of investigational clinical NIRF imaging devices

    Science.gov (United States)

    Zhu, Banghe; Rasmussen, John C.; Litorja, Maritoni; Sevick-Muraca, Eva M.

    2017-03-01

    All medical devices for Food and Drug market approval require specifications of performance based upon International System of Units (SI) or units derived from SI for reasons of traceability. Recently, near-infrared fluorescence (NIRF) imaging devices of a variety of designs have emerged on the market and in investigational clinical studies. Yet the design of devices used in the clinical studies vary widely, suggesting variable device performance. Device performance depends upon optimal excitation of NIRF imaging agents, rejection of backscattered excitation and ambient light, and selective collection of fluorescence emanating from the fluorophore. There remains no traceable working standards with SI units of radiance to enable prediction that a given molecular imaging agent can be detected in humans by a given NIRF imaging device. Furthermore, as technologies evolve and as NIRF imaging device components change, there remains no standardized means to track device improvements over time and establish clinical performance without involving clinical trials, often costly. In this study, we deployed a methodology to calibrate luminescent radiance of a stable, solid phantom in SI units of mW/cm2/sr for characterizing the measurement performance of ICCD and IsCMOS camera based NIRF imaging devices, such as signal-to-noise ratio (SNR) and contrast. The methodology allowed determination of superior SNR of the ICCD over the IsCMOS system; comparable contrast of ICCD and IsCMOS depending upon binning strategies.

  7. Robotic surgery for rectal cancer: current immediate clinical and oncological outcomes.

    Science.gov (United States)

    Araujo, Sergio Eduardo Alonso; Seid, Victor Edmond; Klajner, Sidney

    2014-10-21

    Laparoscopic rectal surgery continues to be a challenging operation associated to a steep learning curve. Robotic surgical systems have dramatically changed minimally invasive surgery. Three-dimensional, magnified and stable view, articulated instruments, and reduction of physiologic tremors leading to superior dexterity and ergonomics. Therefore, robotic platforms could potentially address limitations of laparoscopic rectal surgery. It was aimed at reviewing current literature on short-term clinical and oncological (pathological) outcomes after robotic rectal cancer surgery in comparison with laparoscopic surgery. A systematic review was performed for the period 2002 to 2014. A total of 1776 patients with rectal cancer underwent minimally invasive robotic treatment in 32 studies. After robotic and laparoscopic approach to oncologic rectal surgery, respectively, mean operating time varied from 192-385 min, and from 158-297 min; mean estimated blood loss was between 33 and 283 mL, and between 127 and 300 mL; mean length of stay varied from 4-10 d; and from 6-15 d. Conversion after robotic rectal surgery varied from 0% to 9.4%, and from 0 to 22% after laparoscopy. There was no difference between robotic (0%-41.3%) and laparoscopic (5.5%-29.3%) surgery regarding morbidity and anastomotic complications (respectively, 0%-13.5%, and 0%-11.1%). Regarding immediate oncologic outcomes, respectively among robotic and laparoscopic cases, positive circumferential margins varied from 0% to 7.5%, and from 0% to 8.8%; the mean number of retrieved lymph nodes was between 10 and 20, and between 11 and 21; and the mean distal resection margin was from 0.8 to 4.7 cm, and from 1.9 to 4.5 cm. Robotic rectal cancer surgery is being undertaken by experienced surgeons. However, the quality of the assembled evidence does not support definite conclusions about most studies variables. Robotic rectal cancer surgery is associated to increased costs and operating time. It also seems to be

  8. Predicting failing performance on a standardized patient clinical performance examination: the importance of communication and professionalism skills deficits.

    Science.gov (United States)

    Chang, Anna; Boscardin, Christy; Chou, Calvin L; Loeser, Helen; Hauer, Karen E

    2009-10-01

    The purpose is to determine which assessment measures identify medical students at risk of failing a clinical performance examination (CPX). Retrospective case-control, multiyear design, contingency table analysis, n = 149. We identified two predictors of CPX failure in patient-physician interaction skills: low clerkship ratings (odds ratio 1.79, P = .008) and student progress review for communication or professionalism concerns (odds ratio 2.64, P = .002). No assessments predicted CPX failure in clinical skills. Performance concerns in communication and professionalism identify students at risk of failing the patient-physician interaction portion of a CPX. This correlation suggests that both faculty and standardized patients can detect noncognitive traits predictive of failing performance. Early identification of these students may allow for development of a structured supplemental curriculum with increased opportunities for practice and feedback. The lack of predictors in the clinical skills portion suggests limited faculty observation or feedback.

  9. Dosing of ACE inhibitors in left ventricular dysfunction : Does current clinical dosing provide optimal benefit?

    NARCIS (Netherlands)

    Pinto, YM; van Geel, PP; Alkfaji, H; van Veldhuisen, DJ; van Gilst, WH

    1999-01-01

    In the present review, we discuss the role of clinical dosing of angiotensin converting enzyme (ACE) inhibitors in the treatment of left ventricular dysfunction. Although the precise mechanism of action of ACE inhibitors is still unresolved, the clinical efficacy of ACE inhibitors in the treatment o

  10. Choosing relevant endpoints for older breast cancer patients in clinical trials: an overview of all current clinical trials on breast cancer treatment.

    Science.gov (United States)

    de Glas, N A; Hamaker, M E; Kiderlen, M; de Craen, A J M; Mooijaart, S P; van de Velde, C J H; van Munster, B C; Portielje, J E A; Liefers, G J; Bastiaannet, E

    2014-08-01

    With the ongoing ageing of western societies, the proportion of older breast cancer patients will increase. For several years, clinicians and researchers in geriatric oncology have urged for new clinical trials that address patient-related endpoints such as functional decline after treatment of older patients. The aim of this study was to present an overview of trial characteristics and endpoints of all currently running clinical trials in breast cancer, particularly in older patients. The clinical trial register of the United States National Institutes of Health Differences was searched for all current clinical trials on breast cancer treatment. Trial characteristics and endpoints were retrieved from the register and differences in characteristics between studies in older patients specifically (defined as a lower age-limit of 60 years or older) and trials in all patients were assessed using χ(2) tests. We included 463 clinical trials. Nine trials (2 %) specifically investigated breast cancer treatment in older patients. Ninety-one breast cancer trials included any patient-related endpoint (20 %), while five trials specifically addressing older patients included any patient-related endpoint (56 %, P = 0.02). Five of the trials in older patients incorporated a geriatric assessment (56 %). Clinical trials still rarely incorporate patient-related endpoints, even in trials that specifically address older patients. Trials that are specifically designed for older patients do not often incorporate a geriatric assessment in their design. This implicates that current clinical studies are not expected to fill the gap in knowledge concerning treatment of older breast cancer patients in the next decade.

  11. Long-term cost–effectiveness of Oncotype DX® versus current clinical practice from a Dutch cost perspective

    NARCIS (Netherlands)

    Kip, Michelle Maria Aleida; Monteban, Helma; Steuten, Lotte Maria Gertruda

    2015-01-01

    This study analyzes the incremental cost–effectiveness of Oncotype DX® testing to support adjuvant chemotherapy recommendations, versus current clinical practice, for patients with estrogen receptor-positive (ER+), node-negative or micrometastatic (pN1mic) early-stage breast cancer in The

  12. Long-term cost–effectiveness of Oncotype DX® versus current clinical practice from a Dutch cost perspective

    NARCIS (Netherlands)

    Kip, Michelle; Monteban, Helma; Steuten, Lotte

    2015-01-01

    This study analyzes the incremental cost–effectiveness of Oncotype DX® testing to support adjuvant chemotherapy recommendations, versus current clinical practice, for patients with estrogen receptor-positive (ER+), node-negative or micrometastatic (pN1mic) early-stage breast cancer in The Netherland

  13. Radiotherapy of high-grade gliomas:current standards and new concepts, innovations in imaging and radiotherapy, and new therapeutic approaches

    Institute of Scientific and Technical Information of China (English)

    Frederic Dhermain

    2014-01-01

    The current standards in radiotherapy of high-grade gliomas (HGG) are based on anatomic imaging techniques, usually computed tomography (CT) scanning and magnetic resonance imaging (MRI). The guidelines vary depending on whether the HGG is a histological grade 3 anaplastic glioma (AG) or a grade 4 glioblastoma multiforme (GBM). For AG, T2-weighted MRI sequences plus the region of contrast enhancement in T1 are considered for the delineation of the gross tumor volume (GTV), and an isotropic expansion of 15 to 20 mm is recommended for the clinical target volume (CTV). For GBM, the Radiation Therapy Oncology Group favors a two-step technique, with an initial phase (CTV1) including any T2 hyperintensity area (edema) plus a 20 mm margin treated with up to 46 Gy in 23 fractions, followed by a reduction in CTV2 to the contrast enhancement region in T1 with an additional 25 mm margin. The European Organisation of Research and Treatment of Cancer recommends a single-phase technique with a unique GTV, which comprises the T1 contrast enhancement region plus a margin of 20 to 30 mm. A total dose of 60 Gy in 30 fractions is usual y delivered for GBM, and a dose of 59.4 Gy in 33 fractions is typical y given for AG. As more than 85% of HGGs recur in field, dose-escalation studies have shown that 70 to 75 Gy can be delivered in 6 weeks with relevant toxicities developing in60 Gy. Trials delivering a SIB into a biological GTV showed the feasibility of this treatment, but the final results, in terms of clinical benefits for HGG patients, are stil pending. Many issues have been identified: the variety of MRI and PET machines (and amino-acid tracers), the heterogeneity of the protocols used for image acquisition and post-treatment, the geometric distortion and the unreliable algorithms for co-registration of brain anatomy with functional maps, and the semi-quiescent but highly invasive HGG cells. These issues could be solved by the homogenization of the protocols and software

  14. Establishment of the European College of Veterinary Clinical Pathology (ECVCP) and the current status of veterinary clinical pathology in Europe

    DEFF Research Database (Denmark)

    O'Brien, P.J.; Fournel-Fleury, C.; Bolliger, Adrian Marc

    2007-01-01

    congresses and a joint journal (with the American Society for Veterinary Clinical Pathology) for communication of scientific research and information; the College also maintains a website, a joint listserv, and a newsletter; 6) collaboration in training and continuing education with relevant colleges......) a critical mass of 65 members: 15 original diplomates approved by theEBVS to establish theECVCP, 37 de facto diplomates, 7 diplomates certified by examination, and 5 elected honorary members; 2) the development and certification of training programs, laboratories, and qualified supervisors for residents...

  15. Generalizability of Standardized Patients' Satisfaction Ratings of Their Clinical Encounter with Fourth-Year Medical Students.

    Science.gov (United States)

    Vu, Nu Viet; And Others

    1990-01-01

    At the end of their clinical clerkship rotations, all students in one medical school's classes of 1988 (N=69), 1989 (N=63), 1990 (N=66) took the Post-Clerkship Examination. This study examined the nature of the patients' satisfaction ratings; reliability of patient satisfaction ratings and number of patients needed to derive reliable ratings; etc.…

  16. Setting global standards for stem cell research and clinical translation : The 2016 ISSCR guidelines

    NARCIS (Netherlands)

    Daley, George Q.; Hyun, Insoo; Apperley, Jane F.; Barker, Roger A.; Benvenisty, Nissim; Bredenoord, Annelien L.; Breuer, Christopher K.; Caulfield, Timothy; Cedars, Marcelle I.; Frey-Vasconcells, Joyce; Heslop, Helen E.; Jin, Ying; Lee, Richard T.; McCabe, Christopher; Munsie, Megan; Murry, Charles E.; Piantadosi, Steven; Rao, Mahendra; Rooke, Heather M.; Sipp, Douglas; Studer, Lorenz; Sugarman, Jeremy; Takahashi, Masayo; Zimmerman, Mark; Kimmelman, Jonathan

    2016-01-01

    The International Society for Stem Cell Research (ISSCR) presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016). The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008) to address new and emerging areas of s

  17. Assessment of Measurement Tools of Observation Rate of Nursing Handover Standards in Clinical Wards of Hospital

    Directory of Open Access Journals (Sweden)

    Saadi Amini

    2015-08-01

    Full Text Available Background and objectives : In health centers, clinical information of patient is transferred among care staffs regularly. One of the common cases in information transferring is during the time of nurses’ handover in hospital which performing it correctly will help schedule patient care, providing safety and facilitating exact transferring of information. The aim of this study is investigating validity and reliability of assessment of observance rate of shift handover in clinical wards checklist. Material and Methods : In order to determine the reliability of checklist, two experts panel meetings were held with the presence of 10 experts in clinical field that in those meetings the reliability was investigated with discussion and consensus of participants. Checklist validity was investigated through pilot study in 4 wards of 4 hospitals and calculated by Kronbach- alpha method with 28 cases of shifts handover in morning, noon, and night shift. Results : In studying reliability, the primary checklist was divided into two checklists: patient handover, equipments and ward handover that included 27 and 72 items, respectively. The reliability of patient handover checklist was verified with 0.9155 Kronbach-alpha and that of equipments and ward handover was verified with 0.8779 Kronbach-alpha. Conclusion : Verifying checklists by mentioned scientific and statistical methods showed that these are very powerful instruments that can be used as one of the assessment tools of shift handover in clinical wards to be used towards promoting received services by customers of healthcare system.

  18. Current Status and Future Prospects of Clinical Psychology: Toward a Scientifically Principled Approach to Mental and Behavioral Health Care.

    Science.gov (United States)

    Baker, Timothy B; McFall, Richard M; Shoham, Varda

    2008-11-01

    , physicians typically shared the attitudes of many of today's clinical psychologists, such as valuing personal experience over scientific research. Medicine was reformed, in large part, by a principled effort by the American Medical Association to increase the science base of medical school education. Substantial evidence shows that many clinical psychology doctoral training programs, especially PsyD and for-profit programs, do not uphold high standards for graduate admission, have high student-faculty ratios, deemphasize science in their training, and produce students who fail to apply or generate scientific knowledge. A promising strategy for improving the quality and clinical and public health impact of clinical psychology is through a new accreditation system that demands high-quality science training as a central feature of doctoral training in clinical psychology. Just as strengthening training standards in medicine markedly enhanced the quality of health care, improved training standards in clinical psychology will enhance health and mental health care. Such a system will (a) allow the public and employers to identify scientifically trained psychologists; (b) stigmatize ascientific training programs and practitioners; (c) produce aspirational effects, thereby enhancing training quality generally; and (d) help accredited programs improve their training in the application and generation of science. These effects should enhance the generation, application, and dissemination of experimentally supported interventions, thereby improving clinical and public health. Experimentally based treatments not only are highly effective but also are cost-effective relative to other interventions; therefore, they could help control spiraling health care costs. The new Psychological Clinical Science Accreditation System (PCSAS) is intended to accredit clinical psychology training programs that offer high-quality science-centered education and training, producing graduates who are

  19. The clinical course and standard therapy of systemic lupus erythematosus in the Russian Federation

    Directory of Open Access Journals (Sweden)

    E. L. Nasonov

    2016-01-01

    Full Text Available Data on the clinical course and treatment of such as the severe disease systemic lupus erythematosus (SLE, are virtually lacking in Russia.Objective: to evaluate the clinical presentations of the disease and its treatment in adult patients with active SLE in the cities of three post-Soviet countries (Russia, Ukraine, and Kazakhstan in the ESSENCE study.Patients and methods. This paper concerns Russian patients. The data of clinical cases of 232 patients who were followed up in 6 centers (Moscow, Saint Petersburg, Voronezh, Yekaterinburg, Kursk, and Yaroslavl were studied. The demographic and clinical characteristics of the patients, SLE activity, laboratory and instrumental findings, treatment, and consumed healthcare resources were assessed.Results. The demographic characteristics of patients with SLE were generally comparable to those in other international studies. However, the Russian patients were 4–10 years younger and their SLE duration was 3–7 shorter; the majority of patients were noted to have a severe course of the disease. The level of SLE activity was higher in the patients of our study. There were frequent hospitalizations and unplanned visits to a physician because of exacerbations. The Russian patients who had repeatedly sought medical advice had obvious and severe SLE complications. The disease remained with great probability undiagnosed or misdiagnosed in a sufficiently large number of patients. There were pitfalls in the treatment of SLE: less than half of the patients received antimalarial drugs; nearly 100% took glucocorticoids; nonsteroidal anti-inflammatory drugs were used rarely. The ESSENCE study can form a view of the clinical picture of SLE in Russia. These findings may help to plan healthcare resources in our country.

  20. Clinical and histopathological evaluation of the effect of addition of immunotherapy with Mw vaccine to standard chemotherapy in borderline leprosy.

    Science.gov (United States)

    Kamal, R; Natrajan, M; Katoch, K; Arora, M

    2012-01-01

    This study reports detailed analysis of clinical parameters and clearance of granuloma in borderline leprosy patients treated with immunotherapy and chemotherapy. It aims to assess the additive effect of immunotherapy (Mwvaccine) with standard MDT on clinical status of untreated borderline leprosy cases and on granuloma fraction of untreated borderline leprosy cases. Patients attending the OPD were serially recruited in two groups. A total of 150 cases in one treatment (trial) group (Mw vaccine plus MDT) and 120 cases in another treatment (control) group (MDT only) of border line leprosy have been included. After the formal written consent, detailed clinical examination, charting, smear examination of all untreated borderline patients of both groups was done, biopsies were taken from the active lesions of all patients of both groups at start of therapy and every six month thereafter till the completion of therapy. The same procedure was repeated every six months during the follow-up period. Standard MDT was given to all the patients of both groups according to type of disease. Mw vaccine 0.1 ml (0.5 x 10(9) bacilli) was injected intra-dermally at the start of therapy and every six months in addition to chemotherapy to the treatment group. The BT cases were followed up after 6 doses of MDT and 2 doses of Mw vaccine, and, the BB, BL cases were followed up after 24 doses of MDT plus 5 doses of Mw vaccine. Clinically, greater and faster improvement was observed in all the clinical parameters, faster attainment of smear negativity and two episodes of lepra reaction occurred in cases treated with combined chemotherapy and immunotherapy, as compared to controls (chemotherapy alone) wherein clinical improvement was slower in all parameters, slower attainment of smear negativity in bacillary index and seven showed the occurrence of reactions, histipathologically in addition to more rapid clearance of granuloma in immunotherapy treated group, a significant finding was an

  1. Current status of psychology and clinical psychology in India - an appraisal.

    Science.gov (United States)

    Virudhagirinathan, Baboo Sankar; Karunanidhi, Subbiah

    2014-10-01

    This paper provides an overview of the social and cultural context for the emergence and development of psychology in India and also more specifically of the development of clinical psychology. It details the range of universities offering psychology programmes and the various bodies involved in supporting the development of the psychology. The paper also describes the development of clinical psychology in India and the variety of roles undertaken by clinical psychologists. Finally, it raises a number of issues facing the development of Indian psychology into the future.

  2. Current situation and development countermeasure of China International Standard Dance%中国国际标准舞现状及发展对策

    Institute of Scientific and Technical Information of China (English)

    杜静歌

    2013-01-01

    This paper deals with the international standard dance after entering our country ’s two main devel-opment direction ,Analyzes the current situation and existing problems of China international ballroom ,And put for-ward the development countermeasures of China’s international standard dance .%阐述了国际标准舞进入我国后的两种主要发展方向,分析了当前中国国际标准舞的现状和存在的问题,并提出了发展中国国际标准舞的对策。

  3. Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group.

    Science.gov (United States)

    Provenzano, Elena; Bossuyt, Veerle; Viale, Giuseppe; Cameron, David; Badve, Sunil; Denkert, Carsten; MacGrogan, Gaëtan; Penault-Llorca, Frédérique; Boughey, Judy; Curigliano, Giuseppe; Dixon, J Michael; Esserman, Laura; Fastner, Gerd; Kuehn, Thorsten; Peintinger, Florentia; von Minckwitz, Gunter; White, Julia; Yang, Wei; Symmans, W Fraser

    2015-09-01

    Neoadjuvant systemic therapy is being used increasingly in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is a validated and evaluable surrogate end point of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary end point for clinical trials. However, there is a current lack of uniformity in the definition of pathological complete response. A review of standard operating procedures used by 28 major neoadjuvant breast cancer trials and/or 25 sites involved in such trials identified marked variability in specimen handling and histologic reporting. An international working group was convened to develop practical recommendations for the pathologic assessment of residual disease in neoadjuvant clinical trials of breast cancer and information expected from pathology reports. Systematic sampling of areas identified by informed mapping of the specimen and close correlation with radiological findings is preferable to overly exhaustive sampling, and permits taking tissue samples for translational research. Controversial areas are discussed, including measurement of lesion size, reporting of lymphovascular space invasion and the presence of isolated tumor cells in lymph nodes after neoadjuvant therapy, and retesting of markers after treatment. If there has been a pathological complete response, this must be clearly stated, and the presence/absence of residual ductal carcinoma in situ must be described. When there is residual invasive carcinoma, a comment must be made as to the presence/absence of chemotherapy effect in the breast and lymph nodes. The Residual Cancer Burden is the preferred method for quantifying residual disease in neoadjuvant clinical trials in breast cancer; other methods can be included per trial protocols and regional preference. Posttreatment tumor staging using the Tumor-Node-Metastasis system should be included. These recommendations for standardized

  4. Current issues in clinical research and the development of new pharmaceuticals.

    Science.gov (United States)

    Goldhammer, A

    2001-01-01

    As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the "common rule" if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients' rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo-controlled clinical trials may adversely impact drug development.

  5. Hemodynamic function of the standard St. Jude bileaflet disc valve has no clinical impact 10 years after aortic valve replacement

    DEFF Research Database (Denmark)

    Lund, Ole; Dorup, Inge; Emmertsen, Kristian

    2005-01-01

    OBJECTIVES: Size mismatch and impaired left ventricular function have been shown to determine the hemodynamic function of the standard St. Jude bileaflet disc valve early after aortic valve replacement (AVR). We aimed to analyse St. Jude valve hemodynamic function and its clinical impact in the s......OBJECTIVES: Size mismatch and impaired left ventricular function have been shown to determine the hemodynamic function of the standard St. Jude bileaflet disc valve early after aortic valve replacement (AVR). We aimed to analyse St. Jude valve hemodynamic function and its clinical impact...... in the survivors of a prospective series 10 years after AVR for aortic stenosis. DESIGN: Forty-three survivors aged 32-90 years from a prospective series attended a follow-up study with Doppler echo and radionuclide cardiography 10 years after AVR for aortic stenosis. Six patients with significant left sided valve......Hg. In a multilinear regression analysis GOA indexed for LVEDD, hypertension, and LVEF were independently related to peak gradient. CONCLUSION: High gradients of the standard St. Jude bileaflet disc valve 10 years after AVR was primarily related to systemic hypertension and mismatch between valve and left ventricular...

  6. Current situation of hospital-based endocrinology and clinical nutrition in Spain.

    Science.gov (United States)

    Angeles Gálvez Moreno, M

    2008-01-01

    In 2006, the Healthcare Commission of Spanish Society of Endocrinology and Nutrition did a survey in order to know the actual situation of endocrinology and clinical nutrition healthcare in Public Sanitary Systems in Spain. The survey has been more extensive than the last and it has taken up number and geographical distribution of specialists in Spain in addition to data about clinical assistance. The mean of public hospitals with endocrinologist participation has been 50%.

  7. A Standardized Method of Isolating Adipose-Derived Stem Cells for Clinical Applications.

    Science.gov (United States)

    Raposio, Edoardo; Caruana, Giorgia; Petrella, Maira; Bonomini, Sabrina; Grieco, Michele P

    2016-01-01

    White adipose tissue is the most abundant and accessible source of stem cells in the adult human body. In this paper, we present a standardised and safe method of isolating and maximizing the number of adipose-derived stem cells (ASCs) from conventional liposuction for clinical applications, which was carried out through both mechanical (centrifuge) and enzymatic (collagenase) means. Isolated cells were characterized through flow cytometry assay. Gathered data showed a greater amount (9.06 × 10(5) ASCs from 100 mL of adipose tissue) of isolated ASCs compared to previous protocol, also with high (99%) cell vitality; the procedure we presented is easy and fast (80 minutes), allowing collecting a significative number of mesenchymal stem cells, which can be used for clinical purposes, such as wound healing.

  8. Setting Global Standards for Stem Cell Research and Clinical Translation: The 2016 ISSCR Guidelines

    Directory of Open Access Journals (Sweden)

    George Q. Daley

    2016-06-01

    Full Text Available The International Society for Stem Cell Research (ISSCR presents its 2016 Guidelines for Stem Cell Research and Clinical Translation (ISSCR, 2016. The 2016 guidelines reflect the revision and extension of two past sets of guidelines (ISSCR, 2006; ISSCR, 2008 to address new and emerging areas of stem cell discovery and application and evolving ethical, social, and policy challenges. These guidelines provide an integrated set of principles and best practices to drive progress in basic, translational, and clinical research. The guidelines demand rigor, oversight, and transparency in all aspects of practice, providing confidence to practitioners and public alike that stem cell science can proceed efficiently and remain responsive to public and patient interests. Here, we highlight key elements and recommendations in the guidelines and summarize the recommendations and deliberations behind them.

  9. Detection of nosocomial malnutrition is improved in Amazon region by a standard clinical nutrition education program

    OpenAIRE

    Acuna, K.; Pires, C; Santos, G.; Hashimoto, R.; Pinheiro, L.; MAZUY, N.; Machado, A; OHVEIRA, C.; CAMLLO, M.; WISMANN, R.; Lima, M.; COSTA-MATOS, A.; D. L. Waitzberg; Cruz, T

    2008-01-01

    Background: In Brazil hospital malnutrition is highly prevalent. physician awareness of malnutrition is low, and nutrition therapy is underprescribed. One alternative to approach this problem is to educate health care providers in clinical nutrition. The present study aims to evaluate the effect of an intensive education course given to health care professionals and students on the diagnosis ability concerning to hospital malnutrition. Materials and methods: An intervention study based on a c...

  10. A Delphi Study to Develop a Standard List of Activities that Comprise Routine Clinical Pharmacy Services

    Science.gov (United States)

    2012-06-08

    hospital setting through workload sampling via direct observation. Their work, while limited to only three non -sequential days of sampling , identified...Literature for review was identified utilizing a MEDLINE database search and a subsequent snowball sampling technique to identify additional resources...guarded wide-spread acceptance of the new clinical role of pharmacists within healthcare. In the larger schema, the second and probably the most

  11. A COMPARATIVE CLINICAL EVALUATION OF AYURVEDIC DIET PLAN AND STANDARD DIET PLAN IN STHAULYA (OBESITY

    Directory of Open Access Journals (Sweden)

    Santra Ramen

    2013-10-01

    Full Text Available Foods which are mentioned in Ayurvedic textbooks for the management of obesity are aimed to pacify Kapha Dosha and Medodhatu, cause downward movement of Vata, are rich in dietary fiber and have low glycemic index. The aim of the study was to evaluate the efficacy of diet which is mentioned in Ayurvedic textbook in the management of obesity. 50 subjects with features of obesity as per classics and body mass index (BMI more than 25 kg/m2 were included into study, out of which 40 subjects completed the study. In Ayurveda diet group, diet which contains horsegram, barley, greengram and Kokum fruit was advised. In standard diet group, the standard diet menu was followed according to ICMR guidelines. Both groups were given 1100 kcal diet for eight days. With diet control, both groups underwent brisk walking 20 minutes two times, jogging 20 minutes, Yogasana 40 minutes, cycling 15 minutes, Udvartana (powder massage 20 minutes and Baspasweda (sudation 10 minutes. Ayurvedic diet plan with physical exercise was found to be more effective in reducing all the anthropometric parameters. There was significant reduction in triglyceride (p value 0.000 and VLDL level (p value 0.013 in Ayurvedic diet group. Ayurveda group showed better relief in most of the subjective parameters among which, the effect on pacifying hunger was statistically significant (p value 0.039.

  12. American Clinical Neurophysiology Society Guideline 5: Minimum Technical Standards for Pediatric Electroencephalography.

    Science.gov (United States)

    Kuratani, John; Pearl, Phillip L; Sullivan, Lucy; Riel-Romero, Rosario Maria S; Cheek, Janna; Stecker, Mark; San-Juan, Daniel; Selioutski, Olga; Sinha, Saurabh R; Drislane, Frank W; Tsuchida, Tammy N

    2016-08-01

    This revision to the EEG Guidelines is an update incorporating the current electroencephalography technology and practice. It was previously published as Guideline 2. Similar to the prior guideline, it delineates the aspects of Guideline 1 that should be modified for neonates and young children. Recording conditions for photic stimulation and hyperventilation are revised to enhance the provocation of epileptiform discharges. Revisions recognize the difficulties involved in performing an EEG under sedation in young children. Recommended neonatal EEG montages are displayed for the reduced set of electrodes only since the montages in Guideline 3 should be used for a 21-electrode 10-20 system array. Neonatal documentation is updated to use current American Academy of Pediatrics term "postmenstrual age" rather than "conceptional age." Finally, because therapeutic hypothermia alters the prognostic value of neonatal EEG, the necessity of documenting the patient's temperature at the time of recording is emphasized.

  13. Establishing Evidence-Based Indications for Proton Therapy: An Overview of Current Clinical Trials.

    Science.gov (United States)

    Mishra, Mark V; Aggarwal, Sameer; Bentzen, Soren M; Knight, Nancy; Mehta, Minesh P; Regine, William F

    2017-02-01

    To review and assess ongoing proton beam therapy (PBT) clinical trials and to identify major gaps. Active PBT clinical trials were identified from clinicaltrials.gov and the World Health Organization International Clinical Trials Platform Registry. Data on clinical trial disease site, age group, projected patient enrollment, expected start and end dates, study type, and funding source were extracted. A total of 122 active PBT clinical trials were identified, with target enrollment of >42,000 patients worldwide. Ninety-six trials (79%), with a median planned sample size of 68, were classified as interventional studies. Observational studies accounted for 21% of trials but 71% (n=29,852) of planned patient enrollment. The most common PBT clinical trials focus on gastrointestinal tract tumors (21%, n=26), tumors of the central nervous system (15%, n=18), and prostate cancer (12%, n=15). Five active studies (lung, esophagus, head and neck, prostate, breast) will randomize patients between protons and photons, and 3 will randomize patients between protons and carbon ion therapy. The PBT clinical trial portfolio is expanding rapidly. Although the majority of ongoing studies are interventional, the majority of patients will be accrued to observational studies. Future efforts should focus on strategies to encourage optimal patient enrollment and retention, with an emphasis on randomized, controlled trials, which will require support from third-party payers. Results of ongoing PBT studies should be evaluated in terms of comparative effectiveness, as well as incremental effectiveness and value offered by PBT in comparison with conventional radiation modalities. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Current status, challenges and the way forward for clinical pharmacy service in Ethiopian public hospitals.

    Science.gov (United States)

    Bilal, Arebu Issa; Tilahun, Zelalem; Gebretekle, Gebremedhin Beedemariam; Ayalneh, Belete; Hailemeskel, Bisrat; Engidawork, Ephrem

    2017-05-19

    Clinical pharmacy service has evolved steadily over the past few decades and is now contributing to the 'patient care journey' at all stages. It is improving the safety and effectiveness of medicines and has made a significant contribution to the avoidance of medication errors. In Ethiopia, clinical pharmacy service is in its initial phase, being started in July 2013. This study therefore aimed at assessing the status, challenges and way forward of clinical pharmacy service in the country. A cross-sectional survey was conducted in six regional states and one city- administration in September 2014. A total of 51 hospitals were included in the study. Both qualitative and quantitative methods were employed for data collection. A total of 160 pharmacy graduates, and 51 pharmacy heads participated in the study. Internal Medicine and Pediatric wards were the major wards where the graduates provide clinical pharmacy service. Almost 94% of the new graduates were found to be involved in clinical pharmacy service, but 47% of them rated their service as poor. The overall satisfaction of the graduates was close to 36%. Thirteen hospitals discontinued and two hospitals not even initiated the service largely due to shortage of pharmacists and lac