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  1. Adapting drug approval pathways for bacteriophage-based therapeutics

    Directory of Open Access Journals (Sweden)

    Callum Cooper

    2016-08-01

    Full Text Available The global rise of multi-drug resistant bacteria has resulted in the notion that an antibiotic apocalypse is fast approaching. This has led to a number of well publicized calls for global funding initiatives to develop new antibacterial agents. The long clinical history of phage therapy in Eastern Europe, combined with more recent in vitro and in vivo success, demonstrates the potential for whole phage or phage based antibacterial agents. To date, no whole phage or phage derived products are approved for human therapeutic use in the EU or USA. There are at least three reasons for this: (i phages possess different biological, physical and pharmacological properties compared to conventional antibiotics. Phages need to replicate in order to achieve a viable antibacterial effect, resulting in complex pharmacodynamics / pharmacokinetics. (ii The specificity of individual phages requires multiple phages to treat single species infections, often as part of complex cocktails. (iii The current approval process for antibacterial agents has evolved with the development of chemically based drugs at its core, and is not suitable for phages. Due to similarities with conventional antibiotics, phage derived products such as endolysins are suitable for approval under current processes as biological therapeutic proteins. These criteria render the approval of phages for clinical use theoretically possible but not economically viable. In this review, pitfalls of the current approval process will be discussed for whole phage and phage derived products, in addition to the utilization of alternative approval pathways including adaptive licensing and Right to try legislation.

  2. Psychodiagnostic Testing in APA-Approved Clinical Psychology Programs.

    Science.gov (United States)

    Piotrowski, Chris; Keller, John W.

    The utility and popularity of psychodiagnostic testing has been investigated in applied clinical settings, but little data exist concerning academicians' attitudes toward psychological testing. To assess attitudes toward psychodiagnostic training in doctoral, clinical psychology programs, all fully APA-approved (American Psychological Association)…

  3. Repurposing clinically approved cephalosporins for tuberculosis therapy

    Science.gov (United States)

    Ramón-García, Santiago; González del Río, Rubén; Villarejo, Angel Santos; Sweet, Gaye D.; Cunningham, Fraser; Barros, David; Ballell, Lluís; Mendoza-Losana, Alfonso; Ferrer-Bazaga, Santiago; Thompson, Charles J.

    2016-01-01

    While modern cephalosporins developed for broad spectrum antibacterial activities have never been pursued for tuberculosis (TB) therapy, we identified first generation cephalosporins having clinically relevant inhibitory concentrations, both alone and in synergistic drug combinations. Common chemical patterns required for activity against Mycobacterium tuberculosis were identified using structure-activity relationships (SAR) studies. Numerous cephalosporins were synergistic with rifampicin, the cornerstone drug for TB therapy, and ethambutol, a first-line anti-TB drug. Synergy was observed even under intracellular growth conditions where beta-lactams typically have limited activities. Cephalosporins and rifampicin were 4- to 64-fold more active in combination than either drug alone; however, limited synergy was observed with rifapentine or rifabutin. Clavulanate was a key synergistic partner in triple combinations. Cephalosporins (and other beta-lactams) together with clavulanate rescued the activity of rifampicin against a rifampicin resistant strain. Synergy was not due exclusively to increased rifampicin accumulation within the mycobacterial cells. Cephalosporins were also synergistic with new anti-TB drugs such as bedaquiline and delamanid. Studies will be needed to validate their in vivo activities. However, the fact that cephalosporins are orally bioavailable with good safety profiles, together with their anti-mycobacterial activities reported here, suggest that they could be repurposed within new combinatorial TB therapies. PMID:27678056

  4. The clinically approved antiviral drug sofosbuvir inhibits Zika virus replication

    Science.gov (United States)

    Sacramento, Carolina Q.; de Melo, Gabrielle R.; de Freitas, Caroline S.; Rocha, Natasha; Hoelz, Lucas Villas Bôas; Miranda, Milene; Fintelman-Rodrigues, Natalia; Marttorelli, Andressa; Ferreira, André C.; Barbosa-Lima, Giselle; Abrantes, Juliana L.; Vieira, Yasmine Rangel; Bastos, Mônica M.; de Mello Volotão, Eduardo; Nunes, Estevão Portela; Tschoeke, Diogo A.; Leomil, Luciana; Loiola, Erick Correia; Trindade, Pablo; Rehen, Stevens K.; Bozza, Fernando A.; Bozza, Patrícia T.; Boechat, Nubia; Thompson, Fabiano L.; de Filippis, Ana M. B.; Brüning, Karin; Souza, Thiago Moreno L.

    2017-01-01

    Zika virus (ZIKV) is a member of the Flaviviridae family, along with other agents of clinical significance such as dengue (DENV) and hepatitis C (HCV) viruses. Since ZIKV causes neurological disorders during fetal development and in adulthood, antiviral drugs are necessary. Sofosbuvir is clinically approved for use against HCV and targets the protein that is most conserved among the members of the Flaviviridae family, the viral RNA polymerase. Indeed, we found that sofosbuvir inhibits ZIKV RNA polymerase, targeting conserved amino acid residues. Sofosbuvir inhibited ZIKV replication in different cellular systems, such as hepatoma (Huh-7) cells, neuroblastoma (SH-Sy5y) cells, neural stem cells (NSC) and brain organoids. In addition to the direct inhibition of the viral RNA polymerase, we observed that sofosbuvir also induced an increase in A-to-G mutations in the viral genome. Together, our data highlight a potential secondary use of sofosbuvir, an anti-HCV drug, against ZIKV. PMID:28098253

  5. Integration of new technology into clinical practice after FDA approval.

    Science.gov (United States)

    Govil, Ashul; Hao, Steven C

    2016-10-01

    Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

  6. Linagliptin: a novel methylxanthin based approved dipeptidyl peptidase-4 inhibitor.

    Science.gov (United States)

    Agrawal, Ritesh; Jain, Pratima; Dikshit, S N

    2012-06-01

    Chemically, methylxanthine nucleus based Linagliptin (BI-1356, BI-1356-BS) is a dipeptidyl peptidase-IV inhibitor, which has been developed by Boehringer Ingelheim in association with Lilly for the treatment of Type-II Diabetes. Linagliptin was marketed by Lilly under the trade name Tradjenta and Trajenta. Linagliptin was approved as the once-daily dose by USFDA on 2 May 2011, for the treatment of Type-II Diabetes. Linagliptin 5mg once daily dose was approved based on a clinical trial program, which was conducted on approximately 4,000 adults with Type-II Diabetes. Linagliptin demonstrated statistically significant mean difference in HbA1c from placebo of up to 0.72 percent, when it was used monotherapically. In patients, who were not adequately controlled on metformin or metformin plus sulphonylurea, the addition of Linagliptin resulted in a statistically significant mean difference in HbA1c from placebo of -0.6 percent. Linagliptin was observed to produce significant reduction in fasting plasma glucose (FPG) compared to placebo, when used as a monotherapy in combination with metformin, sulfonylurea and/or pioglitazone. Linagliptin demonstrated significant reduction post-prandial glucose (PPG) levels in two hours as compared with placebo in monotherapy as well as in combination with metformin. In vitro assays also anticipated that Linagliptin is a potent DPPIV inhibitor as well as it exhibits good selectivity for DPP-IV as compared with other DPPs. The in-vivo studies also demonstrated same anticipation with respect to Linagliptin. Consequently, increasing the GLP-1 levels so far improved glucose tolerance in both healthy animals. X-ray crystallography anticipates that Linagliptin complexes with human DPPIV enzyme, e.g. butynyl substituent occupies the S1 hydrophobic pocket of the enzyme; the aminopiperidine substituent in the xanthine scaffold occupies the S2 subsite and its primary amine interacts with the key amino acid residues, which involves in the

  7. Feedback in clinical education, part I: Characteristics of feedback provided by approved clinical instructors.

    Science.gov (United States)

    Nottingham, Sara; Henning, Jolene

    2014-01-01

    Providing students with feedback is an important component of athletic training clinical education; however, little information is known about the feedback that Approved Clinical Instructors (ACIs; now known as preceptors) currently provide to athletic training students (ATSs). To characterize the feedback provided by ACIs to ATSs during clinical education experiences. Qualitative study. One National Collegiate Athletic Association Division I athletic training facility and 1 outpatient rehabilitation clinic that were clinical sites for 1 entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. A total of 4 ACIs with various experience levels and 4 second-year ATSs. Extensive field observations were audio recorded, transcribed, and integrated with field notes for analysis. The constant comparative approach of open, axial, and selective coding was used to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. The ACIs gave 88 feedback statements in 45 hours and 10 minutes of observation. Characteristics of feedback categories included purpose, timing, specificity, content, form, and privacy. Feedback that ACIs provided included several components that made each feedback exchange unique. The ACIs in our study provided feedback that is supported by the literature, suggesting that ACIs are using current recommendations for providing feedback. Feedback needs to be investigated across multiple athletic training education programs to gain more understanding of certain areas of feedback, including frequency, privacy, and form.

  8. Approval of high-risk medical devices in the US: implications for clinical cardiology.

    Science.gov (United States)

    Rome, Benjamin N; Kramer, Daniel B; Kesselheim, Aaron S

    2014-01-01

    Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.

  9. A Survey of Rorschach Teaching in APA-Approved Clinical Graduate Programs

    Science.gov (United States)

    Del Gaudio, Andrew C.; Ritzler, Barry A.

    1976-01-01

    This survey of APA-approved doctoral programs in clinical psychology provides a status assessment of the Rorschach technique. Eighty-one percent emphasized the technique; a quarter offered the course for a full year; respondents with more experience rated the technique higher; and its was rated highly as a clinical tool and teaching aid, but low…

  10. 78 FR 7784 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials To Support Approval of...

    Science.gov (United States)

    2013-02-04

    ... Clinical Trials To Support Approval of Human Drugs and Biological Products; Extension of Comment Period... entitled ``Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological... guidance to industry on enrichment strategies that can be used in clinical trials intended to...

  11. Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

    Science.gov (United States)

    2015-10-01

    Award Number: W81XWH-11-1-0639 TITLE: Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval PRINCIPAL...SEP 2014 – 29 SEP 2015 4. TITLE AND SUBTITLE 5a. CONTRACT NUMBER W81XWH-11-1-0639 Development of Pain Endpoint Models for Use in Prostate Cancer...standard methods for measuring pain palliation and pain progression in prostate cancer clinical trials that are feasible, methodologically rigorous, and

  12. 21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a... feasible and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  13. [Ten years experience with the first approved biosimilar recombinant human growth hormone drug in normal clinical practice].

    Science.gov (United States)

    López-Siguero, Juan Pedro; Palla García, Margarida; Martínez Busto, Elena; Rebollo, Francisco José; Pombo, Manuel

    2017-06-28

    Recombinant human growth hormone (rhGH) is the first biosimilar drug approved by the European Medicines Agency in 2006, using the biosimilar registration process. It was authorised for the treatment of growth hormone deficiency, and growth disorders associated with Turner's syndrome, chronic renal failure, Prader-Willi syndrome, and growth disorders in children/adolescents born small for gestational age, and replacement therapy in adults with pronounced growth hormone deficiency. This review is focused on the scientific evidence published about this drug in the last ten years, including the clinical trials on which the approval of the regulatory authority is based, and the most relevant studies evaluating the clinical impact of the drug in clinical practice. The equivalence between biosimilar and original product has been confirmed in the clinical trials published by Romer et al. and López-Siguero et al. Furthermore, studies carried out in real-life conditions confirm its long-term efficacy and safety, as well as the absence of clinical impact by switching treatment from the original to the biosimilar product. The number of patients receiving this medication has continuously increased since its approval. Its equivalence with the original product has been verified. Preliminary data from the post-authorisation PATRO study confirm the efficacy and safety of the biosimilar product in comparison with data from clinical trials. However, final results must be evaluated at the end of the study, which will provide additional information about the long-term efficacy and safety of the biosimilar drug. Copyright © 2017. Publicado por Elsevier España, S.L.U.

  14. Autosomal dominant polycystic kidney disease: recent advances in clinical management [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Zhiguo Mao

    2016-08-01

    Full Text Available The first clinical descriptions of autosomal dominant polycystic kidney disease (ADPKD go back at least 500 years to the late 16th century. Advances in understanding disease presentation and pathophysiology have mirrored the progress of clinical medicine in anatomy, pathology, physiology, cell biology, and genetics. The identification of PKD1 and PKD2, the major genes mutated in ADPKD, has stimulated major advances, which in turn have led to the first approved drug for this disorder and a fresh reassessment of patient management in the 21st century. In this commentary, we consider how clinical management is likely to change in the coming decade.

  15. Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

    Science.gov (United States)

    2016-10-01

    substantially impair functioning and quality of life. Regulatory standards for the design of symptom endpoints have evolved substantially over the...1d. Submit protocol to departmental review committees at UNC (Month 14) Completed – NOV 2012 1e. Obtain IRB approval at UNC (Months 19) Note...Cabozantinib demonstrated clinically meaningful pain palliation, reduced or eliminated patients’ narcotic use, and improved patient functioning , thus

  16. Insight into the cellular fate and toxicity of aluminium adjuvants used in clinically approved human vaccinations.

    Science.gov (United States)

    Mold, Matthew; Shardlow, Emma; Exley, Christopher

    2016-08-12

    Aluminium adjuvants remain the most widely used and effective adjuvants in vaccination and immunotherapy. Herein, the particle size distribution (PSD) of aluminium oxyhydroxide and aluminium hydroxyphosphate adjuvants was elucidated in attempt to correlate these properties with the biological responses observed post vaccination. Heightened solubility and potentially the generation of Al(3+) in the lysosomal environment were positively correlated with an increase in cell mortality in vitro, potentially generating a greater inflammatory response at the site of simulated injection. The cellular uptake of aluminium based adjuvants (ABAs) used in clinically approved vaccinations are compared to a commonly used experimental ABA, in an in vitro THP-1 cell model. Using lumogallion as a direct-fluorescent molecular probe for aluminium, complemented with transmission electron microscopy provides further insight into the morphology of internalised particulates, driven by the physicochemical variations of the ABAs investigated. We demonstrate that not all aluminium adjuvants are equal neither in terms of their physical properties nor their biological reactivity and potential toxicities both at the injection site and beyond. High loading of aluminium oxyhydroxide in the cytoplasm of THP-1 cells without immediate cytotoxicity might predispose this form of aluminium adjuvant to its subsequent transport throughout the body including access to the brain.

  17. Insight into the cellular fate and toxicity of aluminium adjuvants used in clinically approved human vaccinations

    Science.gov (United States)

    Mold, Matthew; Shardlow, Emma; Exley, Christopher

    2016-08-01

    Aluminium adjuvants remain the most widely used and effective adjuvants in vaccination and immunotherapy. Herein, the particle size distribution (PSD) of aluminium oxyhydroxide and aluminium hydroxyphosphate adjuvants was elucidated in attempt to correlate these properties with the biological responses observed post vaccination. Heightened solubility and potentially the generation of Al3+ in the lysosomal environment were positively correlated with an increase in cell mortality in vitro, potentially generating a greater inflammatory response at the site of simulated injection. The cellular uptake of aluminium based adjuvants (ABAs) used in clinically approved vaccinations are compared to a commonly used experimental ABA, in an in vitro THP-1 cell model. Using lumogallion as a direct-fluorescent molecular probe for aluminium, complemented with transmission electron microscopy provides further insight into the morphology of internalised particulates, driven by the physicochemical variations of the ABAs investigated. We demonstrate that not all aluminium adjuvants are equal neither in terms of their physical properties nor their biological reactivity and potential toxicities both at the injection site and beyond. High loading of aluminium oxyhydroxide in the cytoplasm of THP-1 cells without immediate cytotoxicity might predispose this form of aluminium adjuvant to its subsequent transport throughout the body including access to the brain.

  18. Photoacoustic intra-operative nodal staging using clinically approved superparamagnetic iron oxide nanoparticles

    Science.gov (United States)

    Grootendorst, Diederik J.; Fratila, Raluca M.; Visscher, Martijn; Ten Haken, Bennie; van Wezel, Richard; Steenbergen, Wiendelt; Manohar, Srirang; Ruers, Theo J. M.

    2013-02-01

    Detection of tumor metastases in the lymphatic system is essential for accurate staging of various malignancies, however fast, accurate and cost-effective intra-operative evaluation of the nodal status remains difficult to perform with common available medical imaging techniques. In recent years, numerous studies have confirmed the additional value of superparamagnetic iron oxide dispersions (SPIOs) for nodal staging purposes, prompting the clearance of different SPIO dispersions for clinical practice. We evaluate whether a combination of photoacoustic (PA) imaging and a clinically approved SPIO dispersion, could be applied for intra-operative nodal staging. Metastatic adenocarcinoma was inoculated in Copenhagen rats for 5 or 8 days. After SPIO injection, the lymph nodes were photoacoustically imaged both in vivo and ex vivo whereafter imaging results were correlated with MR and histology. Results were compared to a control group without tumor inoculation. In the tumor groups clear irregularities, as small as 1 mm, were observed in the PA contrast pattern of the nodes together with an decrease of PA response. These irregularities could be correlated to the absence of contrast in the MR images and could be linked to metastatic deposits seen in the histological slides. The PA and MR images of the control animals did not show these features. We conclude that the combination of photoacoustic imaging with a clinically approved iron oxide nanoparticle dispersion is able to detect lymph node metastases in an animal model. This approach opens up new possibilities for fast intra-operative nodal staging in a clinical setting.

  19. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community.

    Science.gov (United States)

    Driver, Vickie R; Gould, Lisa J; Dotson, Peggy; Gibbons, Gary W; Li, William W; Ennis, William J; Kirsner, Robert S; Eaglstein, William H; Bolton, Laura L; Carter, Marissa J

    2017-05-01

    Wounds that exhibit delayed healing add extraordinary clinical, economic, and personal burdens to patients, as well as to increasing financial costs to health systems. New interventions designed to ease such burdens for patients with cancer, renal, or ophthalmologic conditions are often cleared for approval by the U.S. Food and Drug Administration (FDA) using multiple endpoints but the requirement of complete healing as a primary endpoint for wound products impedes FDA clearance of interventions that can provide other clinical or patient-centered benefits for persons with wounds. A multidisciplinary group of wound experts undertook an initiative, in collaboration with the FDA, to identify and content validate supporting FDA criteria for qualifying wound endpoints relevant to clinical practice (CP) and patient-centered outcomes (PCO) as primary outcomes in clinical trials. As part of the initiative, a research study was conducted involving 628 multidisciplinary expert wound clinicians and researchers from 4 different groups: the interdisciplinary core advisory team; attendees of the Spring 2015 Symposium on Advanced Wound Care (SAWC); clinicians employed by a national network of specialty clinics focused on comprehensive wound care; and Association for the Advancement of Wound Care (AAWC) and Wound Healing Society (WHS) members who had not previously completed the survey. The online survey assessed 28 literature-based wound care endpoints for their relevance and importance to clinical practice and clinical research. Fifteen of the endpoints were evaluated for their relevance to improving quality of life. Twenty-two endpoints had content validity indexes (CVI) ≥ 0.75, and 15 were selected as meriting potential inclusion as additional endpoints for FDA approval of future wound care interventions. This study represents an important first step in identifying and validating new measurable wound care endpoints for clinical research and practice and for regulatory

  20. Clinical approved fluorescent dyes coupled to endomicroscopy for in vivo diagnostic of peritoneal carcinomatosis

    Science.gov (United States)

    Abbaci, Muriel; Dartigues, Peggy; Soufan, Ranya; De Leeuw, Frederic; Fabre, Monique; Laplace-Builhé, Corinne

    2015-03-01

    Peritoneal carcinomatosis is metastatic stage aggravating digestive, gynecological or bladder cancer dissemination and the preoperative evaluation of lesions remains difficult. There is therefore a need for minimal invasive innovative techniques to establish a precise preoperative assessment of cancer peritoneal cavity. Probe-based confocal laser endomicroscopy (pCLE) provides dynamic images of the microarchitecture of tissues during an endoscopy. The PERSEE project proposes new developments in robotics and pCLE for the exploration of the peritoneal cavity during laparoscopy. Two fluorescent dyes, Patent blue V and Indocyanine green have been evaluated on human ex vivo samples to improve the contrast of pCLE images. For a future implementation in clinical study, two topically staining protocols operable in vivo have been validated on 70 specimens from 25 patients with a peritoneal carcinomatosis. The specimens were then imaged by pCLE with an optical probe designed for the application. A histo-morphological correlative study was performed on 350 pCLE images and 70 standard histological preparations. All images were interpreted in a random way by two pathologists. Differential histological diagnostics such as normal peritoneum or pseudomyxoma could be recognized on fluorescence images. The statistical analysis of the correlative study is underway. These dyes already approved for human use are interesting for pCLE imaging because some micromorphological criteria look like to conventional histology and are readable by pathologist. Thus pCLE images using both dyes do not require a specific semiology unlike to what is described in the literature, for pCLE associated with fluorescein for the in vivo imaging of pancreatic cysts.

  1. High-resolution label-free vascular imaging using a commercial, clinically approved dermatological OCT scanner

    Science.gov (United States)

    Byers, R. A.; Tozer, G.; Brown, N. J.; Matcher, S. J.

    2016-02-01

    Background and Aim: Recently developed decorrelative techniques such as speckle-variance optical coherence tomography (svOCT) have demonstrated non-invasive depth-resolved imaging of the microcirculation in-vivo. However, bulk tissue motion (BTM) originating from the subject's breathing or heartbeat remains problematic at low imaging speeds, often resulting in full frame decorrelation and a loss of vascular contrast. The aim of this study was to build upon existing svOCT techniques through utilisation of a commercially available, probe-based VivoSight OCT system running at 20 kHz Axial-scan rate. Methods and results: Custom four-dimensional scanning strategies were developed and utilised in order to maximise the interframe correlation during image acquisition. Volumes of structural OCT data were collected from various anatomical regions and processed using the aforementioned svOCT algorithm to reveal angiographic information. Following data collection, three dimensional image registration and novel filtering algorithms were applied to each volume in order to ensure that BTM artefacts were sufficiently suppressed. This enabled accurate visualisation of the microcirculation within the papillary dermis, to a depth of approximately 2mm. Applications of this technique, including quantitative capillary loop density measurement and visualisation of wound healing are demonstrated and enhanced through widefield mosaicing of the svOCT data. Conclusions: Non-invasive microcirculation imaging using an FDA 510(k) approved OCT scanner such as the VivoSight allows direct clinical utilisation of these techniques, in particular for the pathological analysis of skin diseases. This research was supported by BBSRC Doctoral Training Grant: BB/F016840/1. The authors also gratefully acknowledge the use of equipment funded by MRC grant: MR/L012669/1.

  2. 77 FR 74670 - Draft Guidance for Industry on Enrichment Strategies for Clinical Trials to Support Approval of...

    Science.gov (United States)

    2012-12-17

    ... Clinical Trials to Support Approval of Human Drugs and Biological Products; Availability AGENCY: Food and... the availability of a draft guidance for industry entitled ``Enrichment Strategies for Clinical Trials... provide guidance to industry on enrichment strategies that can be used in clinical trials intended...

  3. Oncology drug clinical development and approval in Japan: the role of the pharmaceuticals and medical devices evaluation center (PMDEC).

    Science.gov (United States)

    Fujiwara, Yasuhiro; Kobayashi, Ken

    2002-05-01

    In 1996 the Japanese Diet amended the Pharmaceutical Affairs Law (PAL) and its related laws based on 1996 report of the ad-hoc Committee for Drug Safety Ensuring Measures. Between 1996 and 2000, the drug approval system in Japan underwent a series of radical reforms. We describe in this paper the current system for drug approval, discuss the post-approval reexamination and reevaluation system, conditions under which development and review may be expedited, and mechanisms for approval of off-label usage. Finally, we discuss the impact of the International Conference on Harmonization (ICH) agreement on drug development and review in Japan.

  4. 21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

    Science.gov (United States)

    2010-04-01

    ... Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from studies in animals. (a) FDA may grant marketing approval for a biological product for which safety has... and ethical. Such postmarketing studies would not be feasible until an exigency arises. When...

  5. AMCP Partnership Forum: Enabling the Exchange of Clinical and Economic Information Pre-FDA Approval.

    Science.gov (United States)

    2017-01-01

    Current federal laws and FDA regulations have significantly restricted the sharing of clinical and health economic information on biopharmaceuticals that have yet to receive FDA approval. Over the past several years, organizations that make health care coverage decisions, including those that set copayments, premiums, and formulary placement, have expressed a need for receiving this information before approval, as long as appropriate safeguards exist to prevent this information from reaching unintended entities. Population health decision makers have indicated that waiting until FDA approval is often too late for the critical planning, budgeting, and forecasting associated with health benefit design, especially given the recent influx of high-cost medications and scrutiny for better evaluation and preparation. Recognizing that securities laws restrict the disclosure of nonpublic information and may need to be amended, permissible early dissemination would allow population health decision makers to incorporate clinical and economic information for pipeline drugs or expanded indications into financial forecasting for the following year's plan. Access to this information is needed 12-18 months before FDA approval when organizations are deciding on terms of coverage and budgetary assumptions for state health insurance rate filings, Medicare and Medicaid bids, contracts with health care purchasers, and other financial arrangements. The need for exchange of clinical economic information before FDA approval was first introduced at a previous Academy of Managed Care (AMCP) forum in March 2016, which addressed section 114 of the Food and Drug Administration Modernization Act and the communication of such information after FDA approval. To address preapproval information specifically, AMCP convened a Partnership Forum on September 13-14, 2016. This forum included a diverse group of stakeholders representing managed care, the biopharmaceutical industry, providers, patients

  6. Alirocumab for hyperlipidemia: ODYSSEY Phase III clinical trial results and US FDA approval indications.

    Science.gov (United States)

    Roth, Eli M

    2016-03-01

    A new class of lipid-lowering drugs, inhibitors of PCSK9 has been generating impressive clinical trial data over the last several years, and alirocumab (Praluent) has become the first to be approved by the US FDA. Alirocumab has been shown to lower low density lipoprotein cholesterol by 45-62% with a safety profile generally comparable to placebo. Alirocumab is a monoclonal antibody to PCSK9 administered subcutaneously and has been evaluated in 16 Phase III clinical trials, the majority of which have been enrolled or completed. This article will be a review of the available Phase III safety and efficacy data of the ODYSSEY studies including a brief description of each of the 16 studies.

  7. Ethics approval in applications for open-access clinical trial data: An analysis of researcher statements to clinicalstudydatarequest.com.

    Science.gov (United States)

    So, Derek; Knoppers, Bartha M

    2017-01-01

    Although there are a number of online platforms for patient-level clinical trial data sharing from industry sponsors, they are not very harmonized regarding the role of local ethics approval in the research proposal review process. The first and largest of these platforms is ClinicalStudyDataRequest.com (CSDR), which includes over three thousand trials from thirteen sponsors including GlaxoSmithKline, Novartis, Roche, Sanofi, and Bayer. CSDR asks applicants to state whether they have received ethics approval for their research proposal, but in most cases does not require that they submit evidence of approval. However, the website does require that applicants without ethical approval state the reason it was not required. In order to examine the perspectives of researchers on this topic, we coded every response to that question received by CSDR between June 2014 and February 2017. Of 111 applicants who stated they were exempt from ethics approval, 63% mentioned de-identification, 57% mentioned the use of existing data, 33% referred to local or jurisdictional regulations, and 20% referred to the approvals obtained by the original study. We conclude by examining the experience of CSDR within the broader context of the access mechanisms and policies currently being used by other data sharing platforms, and discuss how our findings might be used to help clinical trial data providers design clear and informative access documents.

  8. Feedback in clinical education, part II: Approved clinical instructor and student perceptions of and influences on feedback.

    Science.gov (United States)

    Nottingham, Sara; Henning, Jolene

    2014-01-01

    Approved Clinical Instructors (ACIs; now known as preceptors) are expected to provide feedback to athletic training students (ATSs) during clinical education experiences. Researchers in other fields have found that clinical instructors and students often have different perceptions of actual and ideal feedback and that several factors may influence the feedback exchanges between instructors and students. However, understanding of these issues in athletic training education is minimal. To investigate the current characteristics and perceptions of and the influences on feedback exchanges between ATSs and ACIs. Qualitative study. One entry-level master's degree program accredited by the Commission on Accreditation of Athletic Training Education. Four ACIs and 4 second-year ATSs. Individual, semistructured interviews were conducted with participants and integrated with field notes and observations for analysis. We used the constant comparative approach to inductively analyze data and develop codes and categories. Member checking, triangulation, and peer debriefing were used to promote trustworthiness of the study. Participants described that feedback plays an important role in clinical education and has several purposes related to improving performance. The ACIs and ATSs also discussed several preferred characteristics of feedback. Participants identified 4 main influences on their feedback exchanges, including the ACI, the ATS, personalities, and the learning environment. The ACIs and ATSs had similar perceptions of ideal feedback in addition to the actual feedback that was provided during their clinical education experiences. Most of the preferences for feedback were aligned with recommendations in the literature, suggesting that existing research findings are applicable to athletic training clinical education. Several factors influenced the feedback exchanges between ACIs and ATSs, which clinical education coordinators should consider when selecting clinical sites

  9. Clinical management of multiple sclerosis and neuromyelitis optica with therapeutic monoclonal antibodies: approved therapies and emerging candidates.

    Science.gov (United States)

    Dubey, Divyanshu; Kieseier, Bernd C; Hartung, Hans Peter; Hemmer, Bernhard; Miller-Little, William A; Stuve, Olaf

    2015-01-01

    Therapeutic monoclonal antibodies (mAbs) are a relatively novel class of drugs that has substantially advanced immunotherapy for patients with multiple sclerosis. The advantage of these agents is that they bind specifically and exclusively to predetermined proteins or cells. Natalizumab was the first mAb in neurology to obtain approval. It is also considered one of the most potent options for annualized relapse rate reduction among available therapeutic options. Alemtuzumab is currently also approved in several countries. Several mAbs have been tested in clinical studies in multiple sclerosis. Here, we review the history of drug development of therapeutic mAbs and their classification. Furthermore, we outline the putative mechanisms of action, clinical evidence and safety of approved mAbs and those in different stages of clinical development in multiple sclerosis and neuromyelitis optica.

  10. Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

    Science.gov (United States)

    Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

    2015-01-01

    The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs.

  11. Effect of clinically approved HDAC inhibitors on Plasmodium, Leishmania and Schistosoma parasite growth

    Directory of Open Access Journals (Sweden)

    Ming Jang Chua

    2017-04-01

    Full Text Available Malaria, schistosomiasis and leishmaniases are among the most prevalent tropical parasitic diseases and each requires new innovative treatments. Targeting essential parasite pathways, such as those that regulate gene expression and cell cycle progression, is a key strategy for discovering new drug leads. In this study, four clinically approved anti-cancer drugs (Vorinostat, Belinostat, Panobinostat and Romidepsin that target histone/lysine deacetylase enzymes were examined for in vitro activity against Plasmodium knowlesi, Schistosoma mansoni, Leishmania amazonensis and L. donovani parasites and two for in vivo activity in a mouse malaria model. All four compounds were potent inhibitors of P. knowlesi malaria parasites (IC50 9–370 nM, with belinostat, panobinostat and vorinostat having 8–45 fold selectivity for the parasite over human neonatal foreskin fibroblast (NFF or human embryonic kidney (HEK 293 cells, while romidepsin was not selective. Each of the HDAC inhibitor drugs caused hyperacetylation of P. knowlesi histone H4. None of the drugs was active against Leishmania amastigote or promastigote parasites (IC50 > 20 μM or S. mansoni schistosomula (IC50 > 10 μM, however romidepsin inhibited S. mansoni adult worm parings and egg production (IC50 ∼10 μM. Modest in vivo activity was observed in P. berghei infected mice dosed orally with vorinostat or panobinostat (25 mg/kg twice daily for four days, with a significant reduction in parasitemia observed on days 4–7 and 4–10 after infection (P < 0.05, respectively.

  12. Evidence-based clinical practice

    DEFF Research Database (Denmark)

    Gluud, Christian

    2002-01-01

    Evidence-based medicine combines the patient's preferences with clinical experience and the best research evidence. Randomized clinical trials are considered the most valid research design for evaluating health-care interventions. However, empirical research shows that intervention effects may be...

  13. Expert committee to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs-comments.

    Science.gov (United States)

    Ghooi, Ravindra B

    2014-07-01

    All is not well with the clinical research industry. Instances of scientific misconduct by investigators, cutting corners by sponsors, irregularities by regulators, have brought a bad name to the industry. These however form a small part of the clinical research done in this country. The US FDA has conducted over 40 audits, and not made any major observations, suggesting that the clinical research in India is by and large above board. Regulators have amended trial rules recently which have cost the industry dear. A committee appointed to formulate the policy and guidelines for approval of new drugs, clinical trials and banning of the drugs has made 25 recommendations of which most are either superfluous or not likely produce the desired effect. Clubbing banning of the drugs with approval of new drugs and clinical trials also does not make sense, since the mechanisms involved are totally different. Barring a few, most recommendations are counterproductive and should be rejected outright. It is time we learnt that appointment of a committee is not the best way to solve a problem.

  14. Approval procedures for clinical trials in the field of radiation oncology; Genehmigungsverfahren klinischer Studien im Bereich der Radioonkologie

    Energy Technology Data Exchange (ETDEWEB)

    Simon, Monique; Buettner, Daniel [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Habeck, Matthias; Habeck, Uta; Brix, Gunnar [Bundesamt fuer Strahlenschutz (BfS), Fachbereich Strahlenschutz und Gesundheit, Neuherberg (Germany); Krause, Mechthild; Baumann, Michael [Deutsches Konsortium fuer Translationale Krebsforschung (DKTK), Dresden (Germany); Deutsches Krebsforschungszentrum (DKFZ), Heidelberg (Germany); Medizinische Fakultaet und Universitaetsklinikum Carl Gustav Carus, Technische Universitaet Dresden, Klinik fuer Strahlentherapie und Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Helmholtz-Zentrum Dresden - Rossendorf, Institut fuer Radioonkologie und OncoRay - Nationales Zentrum fuer Strahlenforschung in der Onkologie, Dresden (Germany); Willich, Normann [Universitaetsklinikum Muenster, Klinik fuer Strahlentherapie - Radioonkologie, Muenster (Germany); Wenz, Frederik [Universitaetsmedizin Mannheim, Medizinische Fakultaet Mannheim, Universitaet Heidelberg, Klinik fuer Strahlentherapie und Radioonkologie, Mannheim (Germany); Schmidberger, Heinz [Universitaetsmedizin Mainz, Klinik fuer Radioonkologie und Strahlentherapie, Mainz (Germany); Debus, Juergen [Universitaetsklinikum Heidelberg, Klinik fuer Radioonkologie und Strahlentherapie, Heidelberg (Germany); Noelling, Torsten

    2015-12-15

    Application of ionizing radiation for the purpose of medical research in Germany needs to be approved by the national authority for radiation protection (Bundesamt fuer Strahlenschutz, BfS). For studies in the field of radiation oncology, differentiation between use of radiation for ''medical care (Heilkunde)'' versus ''medical research'' frequently leads to contradictions. The aim of this article is to provide principle investigators, individuals, and institutions involved in the process, as well as institutional review or ethics committees, with the necessary information for this assessment. Information on the legal frame and the approval procedures are also provided. A workshop was co-organized by the German Society for Radiation Oncology (DEGRO), the Working Party for Radiation Oncology (ARO) of the German Cancer Society (DKG), the German Society for Medical Physics (DGMP), and the German Cancer Consortium (DKTK) in October 2013. This paper summarizes the results of the workshop and the follow-up discussions between the organizers and the BfS. Differentiating between ''Heilkunde'' which does not need to be approved by the BfS and ''medical research'' is whether the specific application of radiation (beam quality, dose, schedule, target volume, etc.) is a clinically established and recognized procedure. This must be answered by the qualified physician(s) (''fachkundiger Arzt'' according to German radiation protection law) in charge of the study and the treatments of the patients within the study, taking into consideration of the best available evidence from clinical studies, guidelines and consensus papers. Among the important parameters for assessment are indication, total dose, and fractionation. Radiation treatments applied outside clinical trials do not require approval by the BfS, even if they are applied within a randomized or nonrandomized clinical trial

  15. Three newly approved drugs for chronic lymphocytic leukemia: incorporating ibrutinib, idelalisib, and obinutuzumab into clinical practice.

    Science.gov (United States)

    Sanford, David S; Wierda, William G; Burger, Jan A; Keating, Michael J; O'Brien, Susan M

    2015-07-01

    Three agents have received Food and Drug Administration (FDA) approval for treatment of chronic lymphocytic leukemia (CLL) within the past year. Ibrutinib and idelalisib block B-cell receptor signaling through inhibition of Bruton tyrosine kinase and phosphatidylinositol 3-kinase δ molecules respectively, interfering with several pathways required for leukemia cell survival. Idelalisib has shown efficacy in the relapsed setting and is currently approved by the FDA for use in combination with rituximab. Ibrutinib has been studied in patients with relapsed CLL and as frontline therapy. In the relapsed setting, these agents produce durable remissions, and might be preferable to re-treatment with chemoimmunotherapy for many patients. Ibrutinib is also effective treatment for patients with deletion 17p and is approved by the FDA as frontline therapy in this patient group, although it does not appear to completely abrogate this adverse prognostic factor. These agents have a unique side effect profile and longer follow-up is required to further understand tolerability and rare adverse effects. Obinutuzumab is a type-2 monoclonal anti-CD20 antibody which results in direct and antibody-dependent cell-mediated cytotoxicity of leukemia cells. It is approved by the FDA for use in combination with chlorambucil, and has shown efficacy in the frontline setting in patients unfit for more intensive chemoimmunotherapy. It produces increased response rates and minimal residual disease negativity compared with chlorambucil/rituximab and is associated with an advantage in progression-free survival but not yet overall survival. These agents underscore our advancement in the understanding of the biology of CLL and will improve outcomes for many patients with CLL.

  16. Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study

    Science.gov (United States)

    Larochelle, Matthieu; Downing, Nicholas S; Ross, Joseph S; David, Frank S

    2017-01-01

    Objective To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. Design A cohort study. Setting New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between 2000 and 2010. Main outcome measures Characteristics of new therapeutics approved by the EMA and/or Health Canada before the FDA, including mechanistic novelty, likely clinical impact, size of the affected population and FDA review outcome. Results From 2001 to 2010, 282 drugs were approved in the USA, Europe or Canada, including 172 (61%) first approved in the USA, 24 (9%) never approved in the USA, and 86 (30%) approved in the USA after Europe and/or Canada. Of the 110 new drugs approved in Europe and/or Canada before the USA, 37 (34%) had a novel mechanisms of action compared with drugs already approved by the FDA, but only 10 (9%) were for conditions lacking alternate available therapies in the USA at the time of ex-US approval—of which the majority (9/10; 90%) were indicated for rare diseases. 12 of the 37 agents with novel mechanisms of action approved first in Europe and/or Canada (32%) had their initial FDA submissions rejected for safety reasons—including 2 drugs that were ultimately withdrawn from the market in Europe due to safety concerns. Conclusions If enacted, reciprocal approval legislation would most likely benefit only a small number of US patients receiving treatment for rare diseases, and the benefit may be somewhat mitigated by an increased exposure to harms. PMID:28179418

  17. Regulatory approval and a first-in-human phase I clinical trial of a monoclonal antibody produced in transgenic tobacco plants.

    Science.gov (United States)

    Ma, Julian K-C; Drossard, Jürgen; Lewis, David; Altmann, Friedrich; Boyle, Julia; Christou, Paul; Cole, Tom; Dale, Philip; van Dolleweerd, Craig J; Isitt, Valerie; Katinger, Dietmar; Lobedan, Martin; Mertens, Hubert; Paul, Mathew J; Rademacher, Thomas; Sack, Markus; Hundleby, Penelope A C; Stiegler, Gabriela; Stoger, Eva; Twyman, Richard M; Vcelar, Brigitta; Fischer, Rainer

    2015-10-01

    Although plant biotechnology has been widely investigated for the production of clinical-grade monoclonal antibodies, no antibody products derived from transgenic plants have yet been approved by pharmaceutical regulators for clinical testing. In the Pharma-Planta project, the HIV-neutralizing human monoclonal antibody 2G12 was expressed in transgenic tobacco (Nicotiana tabacum). The scientific, technical and regulatory demands of good manufacturing practice (GMP) were addressed by comprehensive molecular characterization of the transgene locus, confirmation of genetic and phenotypic stability over several generations of transgenic plants, and by establishing standard operating procedures for the creation of a master seed bank, plant cultivation, harvest, initial processing, downstream processing and purification. The project developed specifications for the plant-derived antibody (P2G12) as an active pharmaceutical ingredient (API) based on (i) the guidelines for the manufacture of monoclonal antibodies in cell culture systems; (ii) the draft European Medicines Agency Points to Consider document on quality requirements for APIs produced in transgenic plants; and (iii) de novo guidelines developed with European national regulators. From the resulting process, a GMP manufacturing authorization was issued by the competent authority in Germany for transgenic plant-derived monoclonal antibodies for use in a phase I clinical evaluation. Following preclinical evaluation and ethical approval, a clinical trial application was accepted by the UK national pharmaceutical regulator. A first-in-human, double-blind, placebo-controlled, randomized, dose-escalation phase I safety study of a single vaginal administration of P2G12 was carried out in healthy female subjects. The successful completion of the clinical trial marks a significant milestone in the commercial development of plant-derived pharmaceutical proteins. © 2015 Society for Experimental Biology, Association of

  18. The Methodology of Clinical Studies Used by the FDA for Approval of High-Risk Orthopaedic Devices.

    Science.gov (United States)

    Barker, Jordan P; Simon, Stephen D; Dubin, Jonathan

    2017-05-03

    The purpose of this investigation was to examine the methodology of clinical trials used by the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of high-risk orthopaedic devices approved between 2001 and 2015. Utilizing the FDA's online public database, this systematic review audited study design and methodological variables intended to minimize bias and confounding. An additional analysis of blinding as well as the Checklist to Evaluate a Report of a Nonpharmacological Trial (CLEAR NPT) was applied to the randomized controlled trials (RCTs). Of the 49 studies, 46 (94%) were prospective and 37 (76%) were randomized. Forty-seven (96%) of the studies were controlled in some form. Of 35 studies that reported it, blinding was utilized in 21 (60%), of which 8 (38%) were reported as single-blinded and 13 (62%) were reported as double-blinded. Of the 37 RCTs, outcome assessors were clearly blinded in 6 (16%), whereas 15 (41%) were deemed impossible to blind as implants could be readily discerned on imaging. When the CLEAR NPT was applied to the 37 RCTs, >70% of studies were deemed "unclear" in describing generation of allocation sequences, treatment allocation concealment, and adequate blinding of participants and outcome assessors. This study manifests the highly variable reporting and strength of clinical research methodology accepted by the FDA to approve high-risk orthopaedic devices.

  19. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

    Science.gov (United States)

    Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

    2011-10-01

    Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

  20. ClinicalTrials.gov and Drugs@FDA: A Comparison of Results Reporting for New Drug Approval Trials.

    Science.gov (United States)

    Schwartz, Lisa M; Woloshin, Steven; Zheng, Eugene; Tse, Tony; Zarin, Deborah A

    2016-09-20

    Pharmaceutical companies and other trial sponsors must submit certain trial results to ClinicalTrials.gov. The validity of these results is unclear. To validate results posted on ClinicalTrials.gov against publicly available U.S. Food and Drug Administration (FDA) reviews on Drugs@FDA. ClinicalTrials.gov (registry and results database) and Drugs@FDA (medical and statistical reviews). 100 parallel-group, randomized trials for new drug approvals (January 2013 to July 2014) with results posted on ClinicalTrials.gov (15 March 2015). 2 assessors extracted, and another verified, the trial design, primary and secondary outcomes, adverse events, and deaths. Most trials were phase 3 (90%), double-blind (92%), and placebo-controlled (73%) and involved 32 drugs from 24 companies. Of 137 primary outcomes identified from ClinicalTrials.gov, 134 (98%) had corresponding data at Drugs@FDA, 130 (95%) had concordant definitions, and 107 (78%) had concordant results. Most differences were nominal (that is, relative difference gov, Drugs@FDA mentioned 1061 (55%) and included results data for 367 (19%). Of 96 trials with 1 or more serious adverse events in either source, 14 could be compared and 7 had discordant numbers of persons experiencing the adverse events. Of 62 trials with 1 or more deaths in either source, 25 could be compared and 17 were discordant. Unknown generalizability to uncontrolled or crossover trial results. Primary outcome definitions and results were largely concordant between ClinicalTrials.gov and Drugs@FDA. Half the secondary outcomes, as well as serious events and deaths, could not be validated because Drugs@FDA includes only "key outcomes" for regulatory decision making and frequently includes only adverse event results aggregated across multiple trials. National Library of Medicine.

  1. Improving data transparency in clinical trials using blockchain smart contracts [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Timothy Nugent

    2016-10-01

    Full Text Available The scientific credibility of findings from clinical trials can be undermined by a range of problems including missing data, endpoint switching, data dredging, and selective publication. Together, these issues have contributed to systematically distorted perceptions regarding the benefits and risks of treatments. While these issues have been well documented and widely discussed within the profession, legislative intervention has seen limited success. Recently, a method was described for using a blockchain to prove the existence of documents describing pre-specified endpoints in clinical trials. Here, we extend the idea by using smart contracts - code, and data, that resides at a specific address in a blockchain, and whose execution is cryptographically validated by the network - to demonstrate how trust in clinical trials can be enforced and data manipulation eliminated. We show that blockchain smart contracts provide a novel technological solution to the data manipulation problem, by acting as trusted administrators and providing an immutable record of trial history.

  2. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012

    OpenAIRE

    Miller, Jennifer E.; Korn, David; Ross, Joseph S

    2015-01-01

    Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by: (1) legal requirements and (2) the ethical standard that all human subjects research should be publicly accessible to contribute to generalisable knowledge. Design: Cross-sectional analysis of all clinical trials submitted to the Food and Drug Administration (FDA) for drugs approved in 2012, sponsored by large biopharmaceutical companies. Data sources Information from Drugs@FDA, ClinicalTrial...

  3. Gadolinium-based contrast media may be nephrotoxic even at approved doses

    Energy Technology Data Exchange (ETDEWEB)

    Thomsen, Henrik S. [Department of Diagnostic Radiology, Copenhagen University Hospital at Herlev, Herlev Ringvej 75, 2730, Herlev (Denmark)

    2004-09-01

    It is generally believed that gadolinium-based contrast media are not nephrotoxic at the approved doses for MR (<0.3 mmol/kg body weight). Recently, a patient with diabetic nephropathy required dialysis because of anuria 6-7 days after MR angiography with 0.14 mmol/kg body weight gadolinium-DTPA-BMA to assess renal artery stenosis. No special precautions (e.g., hydration) had been taken. The serum creatinine levels had been within 200 and 300 {mu}mol/l for the last 3 years with a very slow increase. This case highlights that gadolinium-based contrast media can cause contrast medium-induced nephropathy even at doses below 0.2 mmol/kg body weight in patients with multiple risk factors. (orig.)

  4. Evidence-based clinical guidelines in Kyrgyz Republic.

    Science.gov (United States)

    Zurdinova, A A

    2015-01-01

    Improving quality of care in many countries is one of the priorities of health systems. At the same time one of the most important methods of improving quality of care is the widespread use of methods and principles of evidence-based medicine (EBM) [1]. The implementation of EBM in public health practice provides for the optimization of quality of care in terms of safety, efficacy and cost, one way of which is the use of clinical guidelines. Clinical guidelines developed with the use of EBM, provide an opportunity to use the latest and accurate information to optimize or neutralize impact on physician decision-making of subjective factors such as intuition, expertise, opinion of respected colleagues, recommendations of popular manuals and handbooks, etc. To assess and analyze the developed clinical guidelines (CG) and protocols (CP) in the Kyrgyz Republic in the period from 2008 to 2014 and evaluate their implementation in practical healthcare. Retrospective analysis of the developed clinical guidelines and protocols according to the approved methodology, interviewing leaders, questioning doctors and patients for their implementation. All participants gave informed consent for voluntary participation in the study. Within the framework of the National Program "Manas Taalimi" "Strategy for development of evidence-based medicine in the Kyrgyz Republic for 2006-2010" (MOH Order №490 from 09.04.06) was developed and approved for use. Its main purpose was to create a sustainable system of development, deployment and monitoring of the CG and CP and further promotion of EBM into practical health care, education and science. As a result, a number of documents ("Expert Council for assessing the quality of clinical guidelines/protocols", "AGREE instrument to assess the methodological content of clinical guidelines" [2], "The methodology of development and adaptation of clinical guidelines based on evidence-based medicine") were approved by the Order of the Ministry of

  5. Pharmacological and clinical profile of recently approved second-generation antipsychotics: implications for treatment of schizophrenia in older patients.

    Science.gov (United States)

    Rado, Jeffrey; Janicak, Philip G

    2012-10-01

    Antipsychotics are frequently used in elderly patients to treat a variety of conditions, including schizophrenia. While extensively studied for their impact in younger populations, there is comparatively limited evidence about the effectiveness of these agents in older patients. Further complicating this situation are the high comorbidity rates (both psychiatric and medical) in the elderly; age-related changes in pharmacokinetics that lead to a heightened proclivity for adverse effects; and the potential for multiple, clinically relevant drug interactions. With this background in mind, we review diagnostic and treatment-related issues specific to elderly patients suffering from schizophrenia. We then focus on the potential role of the most recently approved second-generation antipsychotics, paliperidone (both the extended-release oral formulation and the long-acting injectable formulation), iloperidone, asenapine and lurasidone, given the limited clinical experience with these agents in the elderly. While there is limited data to support their safety, tolerability and efficacy in older patients with schizophrenia, each has unique characteristics that should be considered when used in this population.

  6. Genomic variant annotation workflow for clinical applications [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Thomas Thurnherr

    2016-10-01

    Full Text Available Annotation and interpretation of DNA aberrations identified through next-generation sequencing is becoming an increasingly important task. Even more so in the context of data analysis pipelines for medical applications, where genomic aberrations are associated with phenotypic and clinical features. Here we describe a workflow to identify potential gene targets in aberrated genes or pathways and their corresponding drugs. To this end, we provide the R/Bioconductor package rDGIdb, an R wrapper to query the drug-gene interaction database (DGIdb. DGIdb accumulates drug-gene interaction data from 15 different resources and allows filtering on different levels. The rDGIdb package makes these resources and tools available to R users. Moreover, rDGIdb queries can be automated through incorporation of the rDGIdb package into NGS sequencing pipelines.

  7. Subdivisions of the adult zebrafish pallium based on molecular marker analysis [version 2; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Julia Ganz

    2015-11-01

    Full Text Available Background: The telencephalon shows a remarkable structural diversity among vertebrates. In particular, the everted telencephalon of ray-finned fishes has a markedly different morphology compared to the evaginated telencephalon of all other vertebrates. This difference in development has hampered the comparison between different areas of the pallium of ray-finned fishes and the pallial nuclei of all other vertebrates. Various models of homology between pallial subdivisions in ray-finned fishes and the pallial nuclei in tetrapods have been proposed based on connectional, neurochemical, gene expression and functional data. However, no consensus has been reached so far. In recent years, the analysis of conserved developmental marker genes has assisted the identification of homologies for different parts of the telencephalon among several tetrapod species. Results: We have investigated the gene expression pattern of conserved marker genes in the adult zebrafish (Danio rerio pallium to identify pallial subdivisions and their homology to pallial nuclei in tetrapods. Combinatorial expression analysis of ascl1a, eomesa, emx1, emx2, emx3, and Prox1 identifies four main divisions in the adult zebrafish pallium. Within these subdivisions, we propose that Dm is homologous to the pallial amygdala in tetrapods and that the dorsal subdivision of Dl is homologous to part of the hippocampal formation in mouse. We have complemented this analysis be examining the gene expression of emx1, emx2 and emx3 in the zebrafish larval brain. Conclusions: Based on our gene expression data, we propose a new model of subdivisions in the adult zebrafish pallium and their putative homologies to pallial nuclei in tetrapods. Pallial nuclei control sensory, motor, and cognitive functions, like memory, learning and emotion. The identification of pallial subdivisions in the adult zebrafish and their homologies to pallial nuclei in tetrapods will contribute to the use of the zebrafish

  8. 23 CFR Appendix C to Part 1240 - Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)

    Science.gov (United States)

    2010-04-01

    ... Approved Under 23 U.S.C. 153) C Appendix C to Part 1240 Highways NATIONAL HIGHWAY TRAFFIC SAFETY... GRANTS FOR USE OF SEAT BELTS-ALLOCATIONS BASED ON SEAT BELT USE RATES Pt. 1240, App. C Appendix C to Part 1240—Certification (Calendar Year 1998 Survey Based on Survey Approved Under 23 U.S.C. 153)...

  9. Adult attention-deficit/hyperactivity disorder: Associations between subtype and lifetime substance use – a clinical study. [version 1; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Michael Liebrenz

    2015-07-01

    Full Text Available ADHD is the one of the most prevalent childhood disorders and has been associated with impairments persisting into adulthood. Specifically, childhood ADHD is an independent clinical risk factor for the development of later substance use disorders (SUD. Moreover, adults who meet diagnostic criteria for ADHD have shown high rates of comorbid SUDs. Few studies, however, have reported on the relationship between ADHD subtypes and SUD in adult samples. The purpose of this study was to characterize a clinical sample of adults with ADHD and to identify possible associations between ADHD subtypes, lifetime substance use, and if ADHD subtypes may be preferentially associated with specific substances of abuse. We recruited 413 adult ADHD patients, performed an evaluation of their ADHD and conducted an interview on their use of psychotropic substances. Complete data was obtained for 349 patients. Lifetime substance abuse or dependence was 26% and occasional use was 57% in this sample. The inattentive subtype was significantly less likely to abuse or be dependent on cocaine than the combined subtype. Our findings underscore the high rate of comorbidity between substance use and ADHD in adults. The more frequent abuse/dependence of cocaine by adult patients with hyperactive-impulsive symptoms should be kept in mind when treating this patient group.

  10. Adult attention-deficit/hyperactivity disorder: Associations between subtype and lifetime substance use – a clinical study [version 2; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Michael Liebrenz

    2016-10-01

    Full Text Available ADHD is the one of the most prevalent childhood disorders and has been associated with impairments persisting into adulthood. Specifically, childhood ADHD is an independent clinical risk factor for the development of later substance use disorders (SUD. Moreover, adults who meet diagnostic criteria for ADHD have shown high rates of comorbid SUDs. Few studies, however, have reported on the relationship between ADHD subtypes and SUD in adult samples. The purpose of this study was to characterize a clinical sample of adults with ADHD and to identify possible associations between ADHD subtypes, lifetime substance use, and if ADHD subtypes may be preferentially associated with specific substances of abuse. We recruited 413 adult ADHD patients, performed an evaluation of their ADHD and conducted an interview on their use of psychotropic substances. Complete data was obtained for 349 patients. Lifetime substance abuse or dependence was 26% and occasional use was 57% in this sample. The inattentive subtype was significantly less likely to abuse or be dependent on cocaine than the combined subtype. Our findings underscore the high rate of comorbidity between substance use and ADHD in adults. The more frequent abuse/dependence of cocaine by adult patients with hyperactive-impulsive symptoms should be kept in mind when treating this patient group.

  11. A New Level A Type IVIVC for the Rational Design of Clinical Trials Toward Regulatory Approval of Generic Polymeric Long-Acting Injectables.

    Science.gov (United States)

    Somayaji, Mahadevabharath R; Das, Debarun; Przekwas, Andrzej

    2016-10-01

    Chronic neuropsychiatric disorders and diabetes mellitus affect millions of patients and require long-term supervision and expensive medical care. Although repeated drug administration can help manage these diseases, relapses and re-hospitalization owing to patient non-adherence and reduced therapeutic efficacy remain challenging. In response, long-acting injectables, which provide sustained drug release over longer periods at concentrations close to therapeutic ranges, have been proposed. Recent advancements include polymeric long-acting injectables (pLAIs), in which the active pharmaceutical ingredient (API) is encapsulated within U.S. Food and Drug Administration (FDA)-approved biocompatible polymers, such as poly(lactic-co-glycolic acid), or PLGA. Despite significant progress and development in the global pLAI market, FDA guidance for the approval of complex drug products, such as generic pLAIs, is not clearly defined. Although in vitro to in vivo correlation (IVIVC) can facilitate the identification of critical quality attributes (CQAs), drug formulations, and in vitro test platforms for evaluating drug performance in vivo, the application of IVIVC in order to shortlist time- and resource-intensive clinical trials for generic pLAIs has not been reported. Here, we propose a new Level A Type IVIVC that directly correlates the in vitro outcomes, such as drug dissolution, of candidate generic formulations with the clinical characteristics, such as drug absorption, of a reference listed drug (RLD), to help identify the specific generic pLAI formulations with clinical absorptions that are likely to be similar to that of the RLD, thereby reducing the number of clinical trials required for evaluation of clinical bioequivalence (BE). Therefore, the scope of the proposed method is intended only for the rational design of clinical trials, i.e., to shortlist the specific pLAI generic formulations for clinical BE evaluation, and not necessarily to analyze drug performances

  12. Case Report: A case report highlighting bilateral EDB wasting as a clinical marker for lumbar canal stenosis [version 1; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Bijoy Mohan Kumar

    2015-08-01

    Full Text Available Herein we discuss a case of a 55 year old male presenting with history suggestive of sciatica on the left leg. Straight leg raising (SLR test was positive at 45 degrees on the left side. His ankle reflex was absent and the power of extensor hallusus longus (EHL was 4/5 on the same side. MRI lumbosacral spine revealed left paramedian disc prolapsed on L4/L5 level with spinal canal diameter of 9mm.However since his bilateral extensor digitorm brevis (EDB were wasted, we suspected associated lumbar canal stenosis and thereby opted for laminectomy and discectomy in this case. Intraoperatively dural wasting, hypertrophied facets and narrow canal were confirmed. Laminectomy, medial facectectomy and discectomy were carried out. The patient recovered uneventfully with resolution of his sciatica-like pain. Bilateral EDB wasting thereby provides a clinical clue to the underlying lumbar canal stenosis and can help in making correct therapeutic decisions.

  13. The prevalence and clinical significance of anemia in patients hospitalized with acute heart failure [version 2; referees: 2 approved, 1 not approved

    Directory of Open Access Journals (Sweden)

    Attila Frigy

    2017-08-01

    Full Text Available Abstract: In a cohort of patients hospitalized with acute heart failure (AHF the prevalence of anemia and the existence of a correlation between anemia and the severity of the clinical picture were assessed. Methods: 50 consecutive patients (34 men, 16 women, mean age 67.5 years hospitalized with AHF were enrolled.  Statistical analysis was performed for studying correlations between anemia and the presence/levels of diverse parameters (clinical, laboratory, echocardiographic, treatment related  reflecting the severity and prognosis of AHF (α=0.05. Results: 21 patients (14 men, 7 women, mean age 69.6 years, representing 42%, had anemia  at admission. Comparing patients with and without anemia there were no significant differences regarding age,  gender,  presence of atrial fibrillation (p=0.75, diabetes (p=1, ischemic heart disease (p=0.9, left ventricular ejection fraction (EF (p=1, hypotension (p=0.34 and tachycardia>100 b/min at admission (p=0.75, level of eGFR (p=0.72, and need of high dose (>80 mg/day  loop diuretic (p=0.23. However, EF showed a significant positive correlation with eGFR only in AHF patients with anemia (r=0,65, p=0.001. In a multiple regression model, EF had a significant effect on the eGFR quartiles (p=0,004. Conclusions: Anemia is a frequent finding in patients hospitalized with AHF. The presence of anemia was not correlated with other factors related to AHF severity and prognosis. However, a low EF associated with low eGFR was characteristic for patients with anemia, suggesting that the decrease of renal perfusion by low cardiac output further aggravates anemia on the background of chronic kidney disease.

  14. Context based support for Clinical Reasoning

    DEFF Research Database (Denmark)

    Vilstrup Pedersen, Klaus

    2004-01-01

    Intelligence, Knowledge Management Systems and Business Intelligence to make context sensitive, patient case specific analysis and knowledge management. The knowledge base consists of patient health records, reasoning process information and clinical guidelines. Patient specific information and knowledge...

  15. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

    Science.gov (United States)

    Meyskens, Frank L; Curt, Gregory A; Brenner, Dean E; Gordon, Gary; Herberman, Ronald B; Finn, Olivera; Kelloff, Gary J; Khleif, Samir N; Sigman, Caroline C; Szabo, Eva

    2011-03-01

    This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

  16. Experimental strategy of animal trial for the approval of anti-diabetic agents prior to their use in pre-human clinical trials

    Directory of Open Access Journals (Sweden)

    Vivek K. Bajpai

    2016-03-01

    Full Text Available Although several naturally available drugs have been historically used for the treatment of diabetes mellitus throughout the world, few of them have been validated by scientific criteria. Before approval of any drug developed it should pass through animal trial prior to clinical human trial, which should followed by some standard ethical rules. Recently, a large diversity of animal models have been developed to better understand the pathogenesis of diabetes mellitus, and new drugs have been introduced in the market to treat this autoimmune disease. In the present article, we demonstrated some standard handling procedure of animal trial for the approval of anti-diabetic drug, which could be helpful for both academics and industrial scientific community to conduct the animal experiments. This research also contributes in the field of ethnopharmacology to design new strategies for the development of novel drugs to treat this serious condition of diabetes mellitus that constitutes a global public health.

  17. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.

    Science.gov (United States)

    Rathi, Vinay K; Krumholz, Harlan M; Masoudi, Frederick A; Ross, Joseph S

    2015-08-11

    The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle. To characterize the clinical evidence generated for high-risk therapeutic devices over the total product life cycle. All clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents as of October 2014. Studies were characterized by type (pivotal, studies that served as the basis of FDA approval; FDA-required postapproval studies [PAS]; or manufacturer/investigator-initiated); premarket or postmarket; status (completed, ongoing, or terminated/unknown); and design features, including enrollment, comparator, and longest duration of primary effectiveness end point follow-up. In 2010 and 2011, 28 high-risk therapeutic devices received initial marketing approval via the PMA pathway. We identified 286 clinical studies of these devices: 82 (28.7%) premarket and 204 (71.3%) postmarket, among which there were 52 (18.2%) nonpivotal premarket studies, 30 (10.5%) pivotal premarket studies, 33 (11.5%) FDA-required PAS, and 171 (59.8%) manufacturer/investigator-initiated postmarket studies. Six of 33 (18.2%) PAS and 20 of 171 (11.7%) manufacturer/investigator-initiated postmarket studies were reported as completed. No postmarket studies were identified for 5 (17.9%) devices; 3 or fewer were identified for 13 (46.4%) devices overall. Median enrollment was 65 patients (interquartile range [IQR], 25-111), 241 patients (IQR, 147-415), 222 patients (IQR, 119-640), and 250 patients (IQR, 60-800) for nonpivotal premarket, pivotal, FDA-required PAS, and manufacturer

  18. Sincere-Strategy Preference-Based Approval Voting Fully Resists Constructive Control and Broadly Resists Destructive Control

    CERN Document Server

    Erdelyi, Gabor; Rothe, Joerg

    2008-01-01

    We study sincere-strategy preference-based approval voting (SP-AV), a system proposed by Brams and Sanver [Electoral Studies, 25(2):287-305, 2006], with respect to procedural control. In such control scenarios, an external agent seeks to change the outcome of an election via actions such as adding/deleting/partitioning either candidates or voters. SP-AV combines the voters' preference rankings with their approvals of candidates, and we adapt it here so as to keep its useful features with respect to approval strategies even in the presence of control actions. We prove that this system is computationally resistant (i.e., the corresponding control problems are NP-hard) to 19 out of 22 types of constructive and destructive control. Thus, SP-AV has more resistances to control, by three, than is currently known for any other natural voting system with a polynomial-time winner problem. In particular, SP-AV is (after Copeland voting, see Faliszewski et al. [AAIM-2008, Springer LNCS 5034, pp. 165-176, 2008]) the secon...

  19. Magnesium-Based Compression Screws: A Novelty in the Clinical Use of Implants

    Science.gov (United States)

    Seitz, Jan-Marten; Lucas, Arne; Kirschner, Martin

    2016-04-01

    Magnesium alloys are currently subject to much research for use in biodegradable implant applications. The challenge in this field of material development comprises the design of an alloy that provides adequate mechanical and corrosion properties combined with an excellent biocompatibility. While there are many approaches in current literature only one Mg-based application shows the potential to hit the market. MAGNEZIX® Compression Screws are the world's first approved/CE-certified magnesium-based implants designed for use in biodegradable osteosyntheses applications in humans. Therefore, this paper focusses on challenges and current clinical results achieved by means of degradable compression screws. Insights into the screws' process chain and approval processes are given. As these innovative screws have already been on the market for 2 years long-term results based on their use in surgery are discussed.

  20. Comparison of FDA Approved Kinase Targets to Clinical Trial Ones: Insights from Their System Profiles and Drug-Target Interaction Networks

    Directory of Open Access Journals (Sweden)

    Jingyu Xu

    2016-01-01

    Full Text Available Kinase is one of the most productive classes of established targets, but the majority of approved drugs against kinase were developed only for cancer. Intensive efforts were therefore exerted for releasing its therapeutic potential by discovering new therapeutic area. Kinases in clinical trial could provide great opportunities for treating various diseases. However, no systematic comparison between system profiles of established targets and those of clinical trial ones was conducted. The reveal of probable difference or shift of trend would help to identify key factors defining druggability of established targets. In this study, a comparative analysis of system profiles of both types of targets was conducted. Consequently, the systems profiles of the majority of clinical trial kinases were identified to be very similar to those of established ones, but percentages of established targets obeying the system profiles appeared to be slightly but consistently higher than those of clinical trial targets. Moreover, a shift of trend in the system profiles from the clinical trial to the established targets was identified, and popular kinase targets were discovered. In sum, this comparative study may help to facilitate the identification of the druggability of established drug targets by their system profiles and drug-target interaction networks.

  1. Risperidone use in a teaching hospital during its first year after market approval: economic and clinical implications.

    Science.gov (United States)

    Carter, C S; Mulsant, B H; Sweet, R A; Maxwell, R A; Coley, K; Ganguli, R; Branch, R

    1995-01-01

    Risperidone, a new antipsychotic drug, was recently approved by the Food and Drug Administration (FDA) on the basis of its having comparable efficacy and less toxicity than haloperidol. In a preliminary study to evaluate the therapeutic efficiency of this drug, we conducted a survey of resperidone utilization, cost, and safety during its first year of availability at an academic psychiatric hospital. Data were obtained from a computerized, centralized medical record system, from an adverse drug reaction monitoring system, and from pharmacy purchasing records. In its first year of availability, risperidone became the second most widely used antipsychotic agent at our institution. Most of this use extended beyond the adult schizophrenia population, for whom pre-marketing safety and efficacy data are available. The direct institutional cost of risperidone treatment exceeded the entire budget for antipsychotic drugs during the year before its release. Results from the adverse drug reaction reporting system did not indicate a strong advantage of risperidone over more established antipsychotic agents with respect to extrapyramidal side effects. Furthermore, the mean dose of risperidone associated with extrapyramidal symptoms was 3.5 mg/day, considerably lower than that suggested by pre-marketing studies in a more select patient group. These results confirm that new pharmacological agents are generally used in much broader patient populations than those for which efficacy and safety have been established prior to FDA approval. This study also raises questions about the therapeutic efficiency of risperidone compared with other antipsychotic drugs. We conclude that systematic studies of outcome, safety, and cost of new pharmaceuticals in naturalistic settings are needed to provide the data necessary to establish local standards of cost-effective care.

  2. Clinical evidence for Japanese population based on prospective studies--linking clinical trials and clinical practice.

    Science.gov (United States)

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

    "Evidence-based medicine (EBM)" implies effective and high quality practice for patients based on well-grounded medical science. The success of clinical trials in Japan is essential to build original evidence specific for Japanese patients. Based on this concept, we have performed several large-scale clinical trials to provide EBM, including the Japanese Antiplatelets Myocardial Infarction Study [JAMIS; clinical improvement in acute myocardial infarction (AMI) patients with antiplatelet therapy], the Japanese beta-Blockers and Calcium Antagonists Myocardial Infarction (JBCMI; comparison of the effects of beta-blockers and calcium antagonists on cardiovascular events in post-AMI patients), a multicenter study for aggressive lipid-lowering strategy by HMG-CoA reductase inhibitors in patients with AMI (MUSASHI; effects of statin therapy on cardiovascular events in patients with AMI), and the Japanese Primary Prevention of Atherosclerosis with Aspirin for Diabetes (JPAD trial; efficacy of low-dose aspirin therapy for primary prevention of atherosclerotic events in type 2 diabetic patients). The results of these prospective studies were directly linked with clinical practice. We have acquired the know-how of large-scale clinical trials; an important point is to have passion for "buildup evidence specific for the Japanese" and to recruit subjects for enrollment after explaining the significance of "clinical trials for the Japanese".

  3. Pomalidomide: first global approval.

    Science.gov (United States)

    Elkinson, Shelley; McCormack, Paul L

    2013-05-01

    Pomalidomide (Pomalyst(®)) is a small molecule analogue of thalidomide under development with Celgene Corporation for the oral treatment of haematological and connective tissue diseases. Pomalidomide has been approved in the USA and is awaiting approval in the EU for use with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma that has progressed following at least two prior therapies, including lenalidomide and bortezomib. The efficacy and safety of pomalidomide as monotherapy in patients with relapsed and refractory multiple myeloma has also been evaluated in a phase III trial. The agent is in phase III clinical development for the treatment of myelofibrosis and in phase II development for systemic sclerosis. Pomalidomide is also being investigated in patients with amyloidosis, prostate cancer, small cell lung cancer, pancreatic cancer, graft-versus-host disease, and Waldenstrom's macroglobulinaemia. This article summarizes the milestones in the development of pomalidomide leading to this first global approval for relapsed and refractory multiple myeloma.

  4. Recognizing Disjoint Clinical Concepts in Clinical Text Using Machine Learning-based Methods

    OpenAIRE

    Tang, Buzhou; Chen, Qingcai; Wang, Xiaolong; Wu, Yonghui; Zhang, Yaoyun; Jiang, Min; Wang, Jingqi; Xu, Hua

    2015-01-01

    Clinical concept recognition (CCR) is a fundamental task in clinical natural language processing (NLP) field. Almost all current machine learning-based CCR systems can only recognize clinical concepts of consecutive words (called consecutive clinical concepts, CCCs), but can do nothing about clinical concepts of disjoint words (called disjoint clinical concepts, DCCs), which widely exist in clinical text. In this paper, we proposed two novel types of representations for disjoint clinical conc...

  5. Evaluation of a novel web-based prior approval application for palivizumab prophylaxis of respiratory syncytial virus in a state Medicaid program.

    Science.gov (United States)

    Lundeen, Kristin; Pfeiffenberger, Trista; Jacobson Vann, Julie; O'Brien, Timothy; Sampson, Charlene; Wegner, Steven

    2013-03-01

    Recent disproportionate increases in use of specialty medications, such as palivizumab (Synagis), compared with steady utilization of traditional medication use, have prompted complex utilization management strategies that require frequent evaluation to facilitate cost-effectiveness while preserving patient access. Clinical criteria utilized by North Carolina (NC) Medicaid for use of palivizumab for respiratory syncytial virus (RSV) prophylaxis are consistent with the most recent guidelines published in the Red Book: Report of the Committee on Infectious Diseases. Prior to the 2011-2012 RSV season, prior approval (PA) requests were submitted by facsimile using the NC Medicaid Synagis PA form. A web-based PA application, which includes automatic approval capability, monthly dose prompts to providers, and a standardized dose projection formula, was developed for the 2011-2012 RSV season. To evaluate the timeliness of palivizumab coverage determination, compliance with palivizumab prophylaxis regimen, and the accuracy of the dose projection formula achieved with this novel web-based PA application for palivizumab prophylaxis in NC Medicaid recipients. A historically controlled retrospective cohort study was conducted in which all palivizumab PA submissions and supporting documentation from the 2010-2011 and 2011-2012 RSV seasons were retrospectively reviewed for date and time of original submission and final coverage determination. Submissions from the 2011-2012 season were also retrospectively reviewed for number of doses approved, number of doses administered, date of administration of each dose, and actual dosage administered. These data were used to evaluate compliance and the projected versus actual beneficiary weight and dose to assess the accuracy of the dose projection formula. Submissions lacking required information were excluded. Time from PA submission to coverage determination was compared between seasons using a 2-sample t-test. The proportion of

  6. Clinical data interoperability based on archetype transformation.

    Science.gov (United States)

    Costa, Catalina Martínez; Menárguez-Tortosa, Marcos; Fernández-Breis, Jesualdo Tomás

    2011-10-01

    The semantic interoperability between health information systems is a major challenge to improve the quality of clinical practice and patient safety. In recent years many projects have faced this problem and provided solutions based on specific standards and technologies in order to satisfy the needs of a particular scenario. Most of such solutions cannot be easily adapted to new scenarios, thus more global solutions are needed. In this work, we have focused on the semantic interoperability of electronic healthcare records standards based on the dual model architecture and we have developed a solution that has been applied to ISO 13606 and openEHR. The technological infrastructure combines reference models, archetypes and ontologies, with the support of Model-driven Engineering techniques. For this purpose, the interoperability infrastructure developed in previous work by our group has been reused and extended to cover the requirements of data transformation.

  7. Evaluating the first-in-human clinical trial of a human embryonic stem cell-based therapy.

    Science.gov (United States)

    Chapman, Audrey R; Scala, Courtney C

    2012-09-01

    Phase I clinical trials generally raise greater ethical and human protection challenges than later stage clinical trials, suggesting a need to proceed cautiously. This is particularly the case for Phase I trials with a novel therapy being tested in humans for the first time, usually termed first-in-human (FIH) trials. In January 2009, the Food and Drug Administration approved the Investigational New Drug application of Geron Corporation, a small California-based biopharmaceutical company, to initiate a clinical trial to assess GRNOPC1, a human embryonic stem cell-derived candidate therapy for severe spinal cord injuries. This article evaluates the ethical and human subject protection issues raised by the Geron FIH trial. It identifies problems with the approval process and with the conduct of the trial, and then recommends ways to improve review of future proposed trials with novel and high-risk therapies.

  8. From where to what: a neuroanatomically based evolutionary model of the emergence of speech in humans [version 3; referees: 1 approved, 2 approved with reservations

    Directory of Open Access Journals (Sweden)

    Oren Poliva

    2017-09-01

    Full Text Available In the brain of primates, the auditory cortex connects with the frontal lobe via the temporal pole (auditory ventral stream; AVS and via the inferior parietal lobe (auditory dorsal stream; ADS. The AVS is responsible for sound recognition, and the ADS for sound-localization, voice detection and integration of calls with faces. I propose that the primary role of the ADS in non-human primates is the detection and response to contact calls. These calls are exchanged between tribe members (e.g., mother-offspring and are used for monitoring location. Detection of contact calls occurs by the ADS identifying a voice, localizing it, and verifying that the corresponding face is out of sight. Once a contact call is detected, the primate produces a contact call in return via descending connections from the frontal lobe to a network of limbic and brainstem regions. Because the ADS of present day humans also performs speech production, I further propose an evolutionary course for the transition from contact call exchange to an early form of speech. In accordance with this model, structural changes to the ADS endowed early members of the genus Homo with partial vocal control. This development was beneficial as it enabled offspring to modify their contact calls with intonations for signaling high or low levels of distress to their mother. Eventually, individuals were capable of participating in yes-no question-answer conversations. In these conversations the offspring emitted a low-level distress call for inquiring about the safety of objects (e.g., food, and his/her mother responded with a high- or low-level distress call to signal approval or disapproval of the interaction. Gradually, the ADS and its connections with brainstem motor regions became more robust and vocal control became more volitional. Speech emerged once vocal control was sufficient for inventing novel calls.

  9. From where to what: a neuroanatomically based evolutionary model of the emergence of speech in humans [version 2; referees: 1 approved, 2 approved with reservations

    Directory of Open Access Journals (Sweden)

    Oren Poliva

    2016-01-01

    Full Text Available In the brain of primates, the auditory cortex connects with the frontal lobe via the temporal pole (auditory ventral stream; AVS and via the inferior parietal lobe (auditory dorsal stream; ADS. The AVS is responsible for sound recognition, and the ADS for sound-localization, voice detection and integration of calls with faces. I propose that the primary role of the ADS in non-human primates is the detection and response to contact calls. These calls are exchanged between tribe members (e.g., mother-offspring and are used for monitoring location. Detection of contact calls occurs by the ADS identifying a voice, localizing it, and verifying that the corresponding face is out of sight. Once a contact call is detected, the primate produces a contact call in return via descending connections from the frontal lobe to a network of limbic and brainstem regions. Because the ADS of present day humans also performs speech production, I further propose an evolutionary course for the transition from contact call exchange to an early form of speech. In accordance with this model, structural changes to the ADS endowed early members of the genus Homo with partial vocal control. This development was beneficial as it enabled offspring to modify their contact calls with intonations for signaling high or low levels of distress to their mother. Eventually, individuals were capable of participating in yes-no question-answer conversations. In these conversations the offspring emitted a low-level distress call for inquiring about the safety of objects (e.g., food, and his/her mother responded with a high- or low-level distress call to signal approval or disapproval of the interaction. Gradually, the ADS and its connections with brainstem motor regions became more robust and vocal control became more volitional. Speech emerged once vocal control was sufficient for inventing novel calls.

  10. Training in psychodiagnostic testing in APA-approved PsyD and PhD clinical psychology programs.

    Science.gov (United States)

    Piotrowski, C; Zalewski, C

    1993-10-01

    Fifty-one percent (N = 80) of directors of doctoral PhD and PsyD programs in clinical psychology, accredited by the American Psychological Association (APA), responded to a survey on assessment training. The study was a replication of an earlier survey by Piotrowski and Keller (1984b) on instruction, practices, and attitudes on testing. Our findings indicated that training emphasis in assessment coursework has changed very little over the past decade. Intelligence testing was emphasized in most programs, followed by objective and projective personality assessment. However, training in behavioral assessment techniques was required in only half of the responding programs. There were no significant differences between PhD and PsyD programs concerning required coursework in assessment. Factors that influence the perennial importance of testing in the clinical core curriculum are discussed.

  11. Linaclotide: first global approval.

    Science.gov (United States)

    McWilliams, Vanessa; Whiteside, Glenn; McKeage, Kate

    2012-11-12

    Linaclotide is a once-daily, orally administered, first-in-class agonist of guanylate cyclase-C that is minimally absorbed. It is being developed to treat gastrointestinal disorders by Ironwood Pharmaceuticals and its partners, Forest Laboratories (North America), Almirall (Europe) and Astellas Pharma (Asia-Pacific). Linaclotide has received its first global approval in the US for the treatment of constipation-predominant irritable bowel syndrome (IBS-C) and chronic idiopathic constipation (CIC), and a marketing submission has been filed in the EU for IBS-C. This article summarizes the milestones in the development of linaclotide leading to this first approval for IBS-C and CIC. This profile has been extracted and modified from the Adis R&D Insight drug pipeline database. Adis R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  12. Ipilimumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; Whiteside, Glenn; Perry, Caroline

    2011-05-28

    Ipilimumab (Yervoy®) is an anti-cytotoxic T-lymphocyte antigen (CTLA)-4 monoclonal antibody that has been approved in the US for the first- or second-line treatment of patients with malignant melanoma. In the EU, it is awaiting approval as second-line therapy for melanoma. Ipilimumab blocks the effects of the negative T-cell regulator CTLA-4, which may in turn augment T-cell responses to tumour cells. Preclinical studies have indicated that antibody blocking of CTLA-4 can lead to potent immune responses. Ipilimumab is also in development as first- and second-line therapy for prostate cancer where it has progressed to phase III clinical trials worldwide, and it is in phase II development for non-small cell lung cancer. Ipilimumab was originated by the University of California, Berkeley, in the US and subsequently licensed to Medarex, which was later acquired by Bristol-Myers Squibb. This article summarizes the milestones in the development of intravenous ipilimumab leading to this first approval. This profile has been extracted from Wolters Kluwer's R&D Insight drug pipeline database. R&D Insight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch.

  13. Advances in the understanding and clinical management of mastocytosis and clonal mast cell activation syndromes [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    David González-de-Olano

    2016-11-01

    Full Text Available Clonal mast cell activation syndromes and indolent systemic mastocytosis without skin involvement are two emerging entities that sometimes might be clinically difficult to distinguish, and they involve a great challenge for the physician from both a diagnostic and a therapeutic point of view. Furthermore, final diagnosis of both entities requires a bone marrow study; it is recommended that this be done in reference centers. In this article, we address the current consensus and guidelines for the suspicion, diagnosis, classification, treatment, and management of these two entities.

  14. Identification of selective inhibitors of RET and comparison with current clinical candidates through development and validation of a robust screening cascade [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Amanda J. Watson

    2016-05-01

    Full Text Available RET (REarranged during Transfection is a receptor tyrosine kinase, which plays pivotal roles in regulating cell survival, differentiation, proliferation, migration and chemotaxis. Activation of RET is a mechanism of oncogenesis in medullary thyroid carcinomas where both germline and sporadic activating somatic mutations are prevalent.   At present, there are no known specific RET inhibitors in clinical development, although many potent inhibitors of RET have been opportunistically identified through selectivity profiling of compounds initially designed to target other tyrosine kinases. Vandetanib and cabozantinib, both multi-kinase inhibitors with RET activity, are approved for use in medullary thyroid carcinoma, but additional pharmacological activities, most notably inhibition of vascular endothelial growth factor - VEGFR2 (KDR, lead to dose-limiting toxicity. The recent identification of RET fusions present in ~1% of lung adenocarcinoma patients has renewed interest in the identification and development of more selective RET inhibitors lacking the toxicities associated with the current treatments.   In an earlier publication [Newton et al, 2016; 1] we reported the discovery of a series of 2-substituted phenol quinazolines as potent and selective RET kinase inhibitors. Here we describe the development of the robust screening cascade which allowed the identification and advancement of this chemical series.  Furthermore we have profiled a panel of RET-active clinical compounds both to validate the cascade and to confirm that none display a RET-selective target profile.

  15. Korean Clinic Based Outcome Measure Studies

    Directory of Open Access Journals (Sweden)

    Jongbae Park

    2003-02-01

    Full Text Available Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented briefly here including 1 Quality of Life of liver cancer patients after 8 Constitutional acupuncture; 2 Developing a Korean version of Measuring yourself Medical Outcome profile (MYMOP; and 3 Survey on 5 Shu points: a pilot In the first study, we have included 4 primary or secondary liver cancer patients collecting their diagnostic X-ray film and clinical data f개m their hospital, and asked them to fill in the European Organization Research and Treatment of Cancer, Quality of Life Questionnaire before the commencement of the treatment. The acupuncture treatment is set up format but not disclosed yet. The translation and developing a Korean version of outcome measures that is Korean clinician friendly has been sought for MYMOP is one of the most appropriate one. The permission was granted, the translation into Korean was done, then back translated into English only based on the Korean translation by the researcher who is bilingual in both languages. The back translation was compared by the original developer of MYMOP and confirmed usable. In order to test the existence of acupoints and meridians through popular forms of Korean acupuncture regimes, we aim at collecting opinions from 101 Korean clinicians that have used those forms. The questions asked include most effective symptoms, 5 Shu points, points those are least likely to use due to either adverse events or the lack of effectiveness, theoretical reasons for the above proposals, proposing outcome measures

  16. Is there a need to re-examine the approval of bismuth shotshell as a non-toxic alternative to lead based on the precautionary principle?

    Science.gov (United States)

    Fahey, Nathan S C; Tsuji, Leonard J S

    2006-12-01

    In 1997, the Canadian Wildlife Service (CWS) approved bismuth shotshell as an alternative to lead. We assessed whether there is a need to re-examine the toxicity of bismuth issue using the initial CWS toxicity guideline criteria. Review of the literature suggests that in the context of the precautionary principle, a re-examination of the approval of bismuth shotshell should be undertaken based on animal health issues, associated deficiencies in the analytical data used in the original assessment, and to a lesser extent, human health concerns.

  17. 75 FR 958 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2002 Base Year Emission...

    Science.gov (United States)

    2010-01-07

    ... emissions modeling software, MOBILE6. The FMVCP and RVP emission reductions are then removed from the base... and/or VOC) accounting for any growth that occurs during the six year period following the baseline... source emissions accounting for all mobile control measures. The MVEBs for the 2008 RFP are shown...

  18. 75 FR 953 - Approval and Promulgation of Air Quality Implementation Plans; Maryland; 2002 Base Year Emission...

    Science.gov (United States)

    2010-01-07

    ... reductions are determined by the State using EPA's on-road mobile source emissions modeling software, MOBILE6... SIP revision must provide for a 15 percent emission reduction (either NO X and/or VOC) accounting for... the 2008 RFP is based on the projected 2008 mobile source emissions accounting for all mobile...

  19. Clinical applications of plasma based electrosurgical systems

    Science.gov (United States)

    Woloszko, Jean; Endler, Ashley; Ryan, Thomas P.; Stalder, Kenneth R.

    2013-02-01

    Over the past 18 years, several electrosurgical systems generating a low temperature plasma in an aqueous conductive solution have been commercialized for various clinical applications and have been used in over 10 million patients to date. The most popular utilizations are in arthroscopic surgery, otorhinolaryngology surgery, spine and neurosurgery, urology and wound care. These devices can be configured to bring saline to the tip and to have concomitant aspiration to remove by-products and excess fluid. By tuning the electrode geometry, waveform and fluid dynamic at the tip of the devices, tissue resection and thermal effects can be adjusted individually. This allows one to design products that can operate as precise tissue dissectors for treatment of articular cartilage or debridement of chronic wounds, as well as global tissue debulking devices providing sufficient concomitant hemostasis for applications like tonsillectomies. Effects of these plasma based electrosurgical devices on cellular biology, healing response and nociceptive receptors has also been studied in various models. This talk will include a review of the clinical applications, with product descriptions, results and introductory review of some of the research on the biological effects of these devices.

  20. Comparison of the cancer gene targeting and biochemical selectivities of all targeted kinase inhibitors approved for clinical use.

    Directory of Open Access Journals (Sweden)

    Joost C M Uitdehaag

    Full Text Available The anti-proliferative activities of all twenty-five targeted kinase inhibitor drugs that are in clinical use were measured in two large assay panels: (1 a panel of proliferation assays of forty-four human cancer cell lines from diverse tumour tissue origins; and (2 a panel of more than 300 kinase enzyme activity assays. This study provides a head-on comparison of all kinase inhibitor drugs in use (status Nov. 2013, and for six of these drugs, the first kinome profiling data in the public domain. Correlation of drug activities with cancer gene mutations revealed novel drug sensitivity markers, suggesting that cancers dependent on mutant CTNNB1 will respond to trametinib and other MEK inhibitors, and cancers dependent on SMAD4 to small molecule EGFR inhibitor drugs. Comparison of cellular targeting efficacies reveals the most targeted inhibitors for EGFR, ABL1 and BRAF(V600E-driven cell growth, and demonstrates that the best targeted agents combine high biochemical potency with good selectivity. For ABL1 inhibitors, we computationally deduce optimized kinase profiles for use in a next generation of drugs. Our study shows the power of combining biochemical and cellular profiling data in the evaluation of kinase inhibitor drug action.

  1. Case Report: Myelodysplastic syndrome- associated myeloid sarcoma: an unusual clinical presentation of a rare disease [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Emoke Horvath

    2016-02-01

    Full Text Available Myeloid sarcoma results from the extramedullary homing and proliferation of immature myeloid precursors. We present the timeline, events and diagnostic pitfalls related to a 66 year-old male patient’s case, admitted to the Hematology Clinic for pancytopenia, fever, weight loss and fatigue. The severe cytopenia and the few blasts observed in his blood smear indicated a bone marrow biopsy. The bone marrow showed hypercellularity and multilineage dysplasia with the presence of 15% myeloblasts. After the biopsy, he promptly developed paraplegia and nuclear magnetic resonance revealed an epidural tumour which was then resected.In the epidural tumour mass blast-like, round cells were observed with a complex immunophenotype, characterized by myeloperoxidase, CD117, CD15, CD99, leucocyte common antigen positivity and a high Ki-67 proliferation index. Considering the main differential diagnostic issues, the final diagnosis was stated as myelodysplastic syndrome-associated myeloid sarcoma. The prognosis was unfavourable, the bone marrow was quickly invaded by proliferating blast cells, and despite chemotherapy attempts, the patient died.

  2. Nanotechnology-based drug delivery systems for Alzheimer's disease management: Technical, industrial, and clinical challenges.

    Science.gov (United States)

    Wen, Ming Ming; El-Salamouni, Noha S; El-Refaie, Wessam M; Hazzah, Heba A; Ali, Mai M; Tosi, Giovanni; Farid, Ragwa M; Blanco-Prieto, Maria J; Billa, Nashiru; Hanafy, Amira S

    2017-01-10

    Alzheimer's disease (AD) is a neurodegenerative disease with high prevalence in the rapidly growing elderly population in the developing world. The currently FDA approved drugs for the management of symptomatology of AD are marketed mainly as conventional oral medications. Due to their gastrointestinal side effects and lack of brain targeting, these drugs and dosage regiments hinder patient compliance and lead to treatment discontinuation. Nanotechnology-based drug delivery systems (NTDDS) administered by different routes can be considered as promising tools to improve patient compliance and achieve better therapeutic outcomes. Despite extensive research, literature screening revealed that clinical activities involving NTDDS application in research for AD are lagging compared to NTDDS for other diseases such as cancers. The industrial perspectives, processability, and cost/benefit ratio of using NTDDS for AD treatment are usually overlooked. Moreover, active and passive immunization against AD are by far the mostly studied alternative AD therapies because conventional oral drug therapy is not yielding satisfactorily results. NTDDS of approved drugs appear promising to transform this research from 'paper to clinic' and raise hope for AD sufferers and their caretakers. This review summarizes the recent studies conducted on NTDDS for AD treatment, with a primary focus on the industrial perspectives and processability. Additionally, it highlights the ongoing clinical trials for AD management.

  3. Evidence Based Studies in Clinical Transfusion Medicine

    NARCIS (Netherlands)

    A.J.G. Jansen (Gerard)

    2007-01-01

    textabstractAfter the introduction of blood component therapy in the 1960s, more and more attention is given to clinical transfusion medicine. Although blood transfusion is an important treatment in different clinical settings, there are still lack of much randomized clinical trials. Nowadays bloo

  4. Evidence Based Studies in Clinical Transfusion Medicine

    NARCIS (Netherlands)

    A.J.G. Jansen (Gerard)

    2007-01-01

    textabstractAfter the introduction of blood component therapy in the 1960s, more and more attention is given to clinical transfusion medicine. Although blood transfusion is an important treatment in different clinical settings, there are still lack of much randomized clinical trials. Nowadays

  5. FDA'S food ingredient approval process: Safety assurance based on scientific assessment.

    Science.gov (United States)

    Rulis, Alan M; Levitt, Joseph A

    2009-02-01

    Fifty years ago, the Food and Drug Administration (FDA) began implementing new provisions of the Federal Food, Drug, and Cosmetic Act aimed at assuring the safety of new food additives before they enter the marketplace. Today, the agency's procedures for premarket evaluation of food additive safety have evolved into a scientifically rigorous, sound and dependable system whose objective and independent evaluations by FDA scientists assure that new food additives are safe for their intended uses before they arrive on the consumer's plate. Although controversy often surrounds food additives in the popular media and culture, and science-based challenges to FDA's decisions do arise, the agency's original safety judgments successfully withstand these challenges time and again. This article reviews the basic components of the FDA's decision-making process for evaluating the safety of new food additives, and identifies characteristics of this process that are central to assuring that FDA's decisions are marked by scientific rigor and high integrity, and can continue to be relied on by consumers.

  6. Implementation of quality control performance criteria and approved guidelines for upgrading of clinical chemistry laboratory procedures in Alexandria University hospitals.

    Science.gov (United States)

    Rizk, Mohamed Moustafa M; el-Badawi, Nashwa A; Moez, Pacint E; Khattab, Azza A

    2009-03-01

    The aim of the present work was to assess the quality of work in Clinical Pathology Department, Alexandria Main University Hospital, Egypt; as regards the pre-analytical and analytical phases of testing; for later accreditation. This evaluation was performed using inspection sheets that were designed according to the CAP 2006 recommendations. All checklist questions that could not be answered "yes" were considered deficiencies and had to be corrected before being accredited. The questions were classified into ten groups; each group contained a number of questions concerning one of the pre-analytical and analytical assessment activities. We ranked our results into 4 categories according to the degree of fulfillment. The total number of questions that were answered "no" at the start and the end of the study accounted for 64/101 (63.4%) and 34/101 (33.7%) questions respectively. Most of the deficiencies were detected in the pre-analytical phase of the testing process; the first two checklists were used for the evaluation of this phase. At the start of the study, the degree of requirements fulfillment in checklist I and II were 0% and 21.1% respectively. By the end of the study the degree of fulfillment became, 85.7% and 63.2% respectively. Average number of sample rejection due to different causes was evaluated before and after implementing CAP recommendations; these causes include haemolysis, clotted serum, quantity not sufficient, and lost samples; the percentage of rejected samples before implementing CAP recommendations was 15.8%, 1.81%, 0.70%, and 0.51% respectively, while after implementing CAP recommendations it was 7%, 0.77%, 0.08%, and 0.05%, respectively. We concluded that the presence of standardized protocol for the pre-analytical activities had improved the quality of samples received by the lab, and we also concluded that accreditation allows laboratories to evaluate their performance, their compliance with the requirements of the accrediting association

  7. Pharmacokinetic-pharmacodynamic relationship of anesthetic drugs: from modeling to clinical use [version 1; referees: 4 approved

    Directory of Open Access Journals (Sweden)

    Valerie Billard

    2015-11-01

    Full Text Available Anesthesia is a combination of unconsciousness, amnesia, and analgesia, expressed in sleeping patients by limited reaction to noxious stimulations. It is achieved by several classes of drugs, acting mainly on central nervous system. Compared to other therapeutic families, the anesthetic drugs, administered by intravenous or pulmonary route, are quickly distributed in the blood and induce in a few minutes effects that are fully reversible within minutes or hours. These effects change in parallel with the concentration of the drug, and the concentration time course of the drug follows with a reasonable precision mathematical models based on the Fick principle. Therefore, understanding concentration time course allows adjusting the dosing delivery scheme in order to control the effects.   The purpose of this short review is to describe the basis of pharmacokinetics and modeling, the concentration-effects relationship, and drug interactions modeling to offer to anesthesiologists and non-anesthesiologists an overview of the rules to follow to optimize anesthetic drug delivery.

  8. Drugs Approved for Melanoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Melanoma This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Melanoma Aldesleukin Cobimetinib Cotellic (Cobimetinib) Dabrafenib Dacarbazine DTIC-Dome ( ...

  9. The academic, economic and societal impacts of Open Access: an evidence-based review [version 3; referees: 3 approved, 2 approved with reservations

    Directory of Open Access Journals (Sweden)

    Jonathan P. Tennant

    2016-09-01

    Full Text Available Ongoing debates surrounding Open Access to the scholarly literature are multifaceted and complicated by disparate and often polarised viewpoints from engaged stakeholders. At the current stage, Open Access has become such a global issue that it is critical for all involved in scholarly publishing, including policymakers, publishers, research funders, governments, learned societies, librarians, and academic communities, to be well-informed on the history, benefits, and pitfalls of Open Access. In spite of this, there is a general lack of consensus regarding the potential pros and cons of Open Access at multiple levels. This review aims to be a resource for current knowledge on the impacts of Open Access by synthesizing important research in three major areas: academic, economic and societal. While there is clearly much scope for additional research, several key trends are identified, including a broad citation advantage for researchers who publish openly, as well as additional benefits to the non-academic dissemination of their work. The economic impact of Open Access is less well-understood, although it is clear that access to the research literature is key for innovative enterprises, and a range of governmental and non-governmental services. Furthermore, Open Access has the potential to save both publishers and research funders considerable amounts of financial resources, and can provide some economic benefits to traditionally subscription-based journals. The societal impact of Open Access is strong, in particular for advancing citizen science initiatives, and leveling the playing field for researchers in developing countries. Open Access supersedes all potential alternative modes of access to the scholarly literature through enabling unrestricted re-use, and long-term stability independent of financial constraints of traditional publishers that impede knowledge sharing. However, Open Access has the potential to become unsustainable for

  10. The academic, economic and societal impacts of Open Access: an evidence-based review [version 1; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Jonathan P. Tennant

    2016-04-01

    increasing engagement with researchers regarding ethical standards of publishing. We recommend that Open Access supporters focus their efforts on working to establish viable new models and systems of scholarly communication, rather than trying to undermine the existing ones as part of the natural evolution of the scholarly ecosystem. Based on this, future research should investigate the wider impacts of an ecosystem-wide transformation to a system of Open Research.

  11. The academic, economic and societal impacts of Open Access: an evidence-based review [version 2; referees: 4 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Jonathan P. Tennant

    2016-06-01

    Full Text Available Ongoing debates surrounding Open Access to the scholarly literature are multifaceted and complicated by disparate and often polarised viewpoints from engaged stakeholders. At the current stage, Open Access has become such a global issue that it is critical for all involved in scholarly publishing, including policymakers, publishers, research funders, governments, learned societies, librarians, and academic communities, to be well-informed on the history, benefits, and pitfalls of Open Access. In spite of this, there is a general lack of consensus regarding the potential pros and cons of Open Access at multiple levels. This review aims to be a resource for current knowledge on the impacts of Open Access by synthesizing important research in three major areas: academic, economic and societal. While there is clearly much scope for additional research, several key trends are identified, including a broad citation advantage for researchers who publish openly, as well as additional benefits to the non-academic dissemination of their work. The economic impact of Open Access is less well-understood, although it is clear that access to the research literature is key for innovative enterprises, and a range of governmental and non-governmental services. Furthermore, Open Access has the potential to save both publishers and research funders considerable amounts of financial resources, and can provide some economic benefits to traditionally subscription-based journals. The societal impact of Open Access is strong, in particular for advancing citizen science initiatives, and leveling the playing field for researchers in developing countries. Open Access supersedes all potential alternative modes of access to the scholarly literature through enabling unrestricted re-use, and long-term stability independent of financial constraints of traditional publishers that impede knowledge sharing. However, Open Access has the potential to become unsustainable for

  12. Emerging concepts in dendrimer-based nanomedicine: from design principles to clinical applications.

    Science.gov (United States)

    Kannan, R M; Nance, E; Kannan, S; Tomalia, D A

    2014-12-01

    Dendrimers are discrete nanostructures/nanoparticles with 'onion skin-like' branched layers. Beginning with a core, these nanostructures grow in concentric layers to produce stepwise increases in size that are similar to the dimensions of many in vivo globular proteins. These branched tree-like concentric layers are referred to as 'generations'. The outer generation of each dendrimer presents a precise number of functional groups that may act as a monodispersed platform for engineering favourable nanoparticle-drug and nanoparticle-tissue interactions. These features have attracted significant attention in medicine as nanocarriers for traditional small drugs, proteins, DNA/RNA and in some instances as intrinsically active nanoscale drugs. Dendrimer-based drugs, as well as diagnostic and imaging agents, are emerging as promising candidates for many nanomedicine applications. First, we will provide a brief survey of recent nanomedicines that are either approved or in the clinical approval process. This will be followed by an introduction to a new 'nanoperiodic' concept which proposes nanoparticle structure control and the engineering of 'critical nanoscale design parameters' (CNDPs) as a strategy for optimizing pharmocokinetics, pharmocodynamics and site-specific targeting of disease. This paradigm has led to the emergence of CNDP-directed nanoperiodic property patterns relating nanoparticle behaviour to critical in vivo clinical translation issues such as cellular uptake, transport, elimination, biodistribution, accumulation and nanotoxicology. With a focus on dendrimers, these CNDP-directed nanoperiodic patterns are used as a strategy for designing and optimizing nanoparticles for a variety of drug delivery and imaging applications, including a recent dendrimer-based theranostic nanodevice for imaging and treating cancer. Several emerging preclinical dendrimer-based nanotherapy concepts related to inflammation, neuro-inflammatory disorders, oncology and infectious

  13. Biosimilars approval process.

    Science.gov (United States)

    Zuñiga, Leyre; Calvo, Begoña

    2010-04-01

    For similar biological medicinal products, the so-called biosimilars, clinical trials are required rather than just the bioequivalence studies required to support the registration of a generic small molecule drug product. The EU Directive 2001/83/EC, as amended, stated that where a biological medicinal product which is similar to a reference biological product, does not meet the conditions in the definition of generic medicinal products the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided. The challenge is to determine the exact nature of the non-clinical and clinical programme required to gain regulatory approval. The applicant is encouraged to provide a detailed description of the strategy used to demonstrate the biosimilar and the reference product have similar profiles in terms of quality, safety and efficacy. The extent to which comparability can be proven will have quite an impact on how many non-clinical and clinical studies the biosimilar applicant will be required to conduct. The dossier submitted by the applicant to the EMEA should cover all aspects of the comparability assessment and must include data on possible unwanted immune reactions to the therapeutic protein. Post-marketing pharmacovigilance plans are also expected to be included in the biosimilar dossier.

  14. Campus Clinical: simulation-based curriculum designed to meet clinical course learning outcomes.

    Science.gov (United States)

    Jarvis, Michelle; Rivers, Julie

    2014-01-01

    Campus Clinical is a simulation-based curriculum designed to meet the challenge of decreasing clinical spaces in maternal-child units. The curriculum framework is situated in a constructivist, experiential learning context, integrating Chickering and Gamson's principles for good practice in education. This innovative approach to meeting clinical course learning outcomes is transferable to a variety of settings.

  15. Role of clinical images based teaching as a supplement to conventional clinical teaching in dermatology

    Directory of Open Access Journals (Sweden)

    Gurumoorthy Rajesh Kumar

    2015-01-01

    Full Text Available Introduction : Clinical Dermatology is a visually oriented specialty, where visually oriented teaching is more important than it is in any other specialty. It is essential that students must have repeated exposure to common dermatological disorders in the limited hours of Dermatology clinical teaching. Aim: This study was conducted to assess the effect of clinical images based teaching as a supplement to the patient based clinical teaching in Dermatology, among final year MBBS students. Methods: A clinical batch comprising of 19 students was chosen for the study. Apart from the routine clinical teaching sessions, clinical images based teaching was conducted. This teaching method was evaluated using a retrospective pre-post questionnaire. Students′ performance was assessed using Photo Quiz and an Objective Structured Clinical Examination (OSCE. Feedback about the addition of images based class was collected from students. Results: A significant improvement was observed in the self-assessment scores following images based teaching. Mean OSCE score was 6.26/10, and that of Photo Quiz was 13.6/20. Conclusion : This Images based Dermatology teaching has proven to be an excellent supplement to routine clinical cases based teaching.

  16. Pharmaceutical and clinical development of phosphonate-based radiopharmaceuticals for the targeted treatment of bone metastases.

    Science.gov (United States)

    Lange, Rogier; Ter Heine, Rob; Knapp, Russ Ff; de Klerk, John M H; Bloemendal, Haiko J; Hendrikse, N Harry

    2016-10-01

    Therapeutic phosphonate-based radiopharmaceuticals radiolabeled with beta, alpha and conversion electron emitting radioisotopes have been investigated for the targeted treatment of painful bone metastases for >35years. We performed a systematic literature search and focused on the pharmaceutical development, preclinical research and early human studies of these radiopharmaceuticals. The characteristics of an ideal bone-targeting therapeutic radiopharmaceutical are presented and compliance with these criteria by the compounds discussed is verified. The importance of both composition and preparation conditions for the stability and biodistribution of several agents is discussed. Very few studies have described the characterization of these products, although knowledge on the molecular structure is important with respect to in vivo behavior. This review discusses a total of 91 phosphonate-based therapeutic radiopharmaceuticals, of which only six agents have progressed to clinical use. Extensive clinical studies have only been described for (186)Re-HEDP, (188)Re-HEDP and (153)Sm-EDTMP. Of these, (153)Sm-EDTMP represents the only compound with worldwide marketing authorization. (177)Lu-EDTMP has recently received approval for clinical use in India. This review illustrates that a thorough understanding of the radiochemistry of these agents is required to design simple and robust preparation and quality control methods, which are needed to fully exploit the potential benefits of these theranostic radiopharmaceuticals. Extensive biodistribution and dosimetry studies are indispensable to provide the portfolios that are required for assessment before human administration is possible. Use of the existing knowledge collected in this review should guide future research efforts and may lead to the approval of new promising agents.

  17. FDA Approves Two HPV Vaccines: Cervarix for Girls, Gardasil for Boys | Division of Cancer Prevention

    Science.gov (United States)

    The FDA has approved a second vaccine to prevent cervical cancer and cervical precancers, the vaccine’s manufacturer, GlaxoSmithKline (GSK), announced last week. The approval is based on data from a large clinical trial showing that the vaccine, Cervarix, prevented precancerous lesions in 93 percent of those who received the full vaccine sequence of three injections over 6 months. |

  18. An innovative clinical practicum to teach evidence-based practice.

    Science.gov (United States)

    Brancato, Vera C

    2006-01-01

    A clinical practicum was successfully implemented for RN to BSN students to apply evidence-based practice to actual clinical problems affecting nursing practice. The author describes how this practicum was implemented and the requisite resources and support systems. This senior-level capstone course enabled students to understand and value a lifelong learning approach to evidence-based practice.

  19. Annotating Evidence Based Clinical Guidelines: A Lightweight Ontology

    NARCIS (Netherlands)

    R. Hoekstra; A. de Waard; R. Vdovjak

    2012-01-01

    This paper describes a lightweight ontology for representing annotations of declarative evidence based clinical guidelines. We present the motivation and requirements for this representation, based on an analysis of several guidelines. The ontology provides the means to connect clinical questions an

  20. Development of Task-Based Learning Outcomes according to Clinical Presentations for Clinical Clerkships.

    Science.gov (United States)

    Roh, HyeRin; Rhee, Byoung Doo; Lee, Jong Tae; Bae, Sang Kyun

    2012-03-01

    The aim of the study was to introduce our experience of establish task-based learning outcomes for core clinical clerkships. We first define our educational goal and objectives of the clinical clerkship curriculum according to knowledge, cognitive function and skill, and attitude. We selected clinical presentations and related diseases with expert panels and allocated them to core clinical departments. We classified doctor's tasks into 6 categories: history taking, physical examination, diagnostic plan, therapeutic plan, acute and emergent management, and prevention and patient education. We described learning outcomes by task using behavioral terms. We established goals and objectives for students to achieve clinical competency on a primary care level. We selected 75 clinical presentations and described 377 learning outcomes. Our process can benefit medical schools that offer outcome-based medical education, especially for clinical clerkships. To drive effective clerkships, a supportive system including assessment and faculty development should be implemented.

  1. Molecular and Clinical Based Cardiovascular Care Program

    Science.gov (United States)

    2010-11-01

    vegetarian diet, exercise, stress management, group support), 186 subjects enrolled and 144 participated for 1 year. ■ RESULTS: At 3 months and 1...scoring system based on essential elements of the lacto-ovo vegetarian dietary pattern. Exercise and stress management adherence were not capped at...base- line low-fat diet and further decreased their dietary fat intake to 8.8% of total energy with adherence to a lacto-ovo vegetarian diet. The

  2. Evidence-based clinical practice guideline: inhaled nitric oxide for neonates with acute hypoxic respiratory failure.

    Science.gov (United States)

    DiBlasi, Robert M; Myers, Timothy R; Hess, Dean R

    2010-12-01

    Inhaled nitric oxide (INO) is a colorless, odorless gas that is also a potent pulmonary vasodilator. When given via the inhaled route it is a selective pulmonary vasodilator. INO is approved by the United States Food and Drug Administration (FDA) for the treatment of term and near-term neonates with hypoxemic respiratory failure associated with clinical or echocardiographic evidence of pulmonary arterial hypertension. A systematic review of the literature was conducted with the intention of making recommendations related to the clinical use of INO for its FDA-approved indication. Specifically, we wrote these evidence-based clinical practice guidelines to address the following questions: (1) What is the evidence for labeled use? (2) What are the specific indications for INO for neonates with acute hypoxemic respiratory failure? (3) Does the use of INO impact oxygenation, mortality, or utilization of extracorporeal membrane oxygenation (ECMO)? (4) Does INO affect long-term outcomes? (5) Is INO cost-effective therapy? (6) How is the appropriate dosing regimen and dose response to INO established? (7) How is the dose of INO titrated and weaned? (8) Which INO delivery system should be used? (9) How should INO be implemented with different respiratory support devices? (10) What adverse effects of INO should be monitored, and at what frequency? (11) What physiologic parameters should be monitored during INO? (12) Is scavenging of gases necessary to protect the caregivers? Using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) scoring system, 22 recommendations are developed for the use of INO in newborns.

  3. Methodological Aspects in Studies Based on Clinical Routine Data.

    Science.gov (United States)

    Kennes, Lieven Nils

    2017-09-12

    Randomized controlled clinical trials are regarded as the gold standard for comparing different clinical interventions, but generally their conduct is operationally cumbersome, time-consuming, and expensive. Studies and investigations based on clinical routine data on the contrary utilize existing data acquired under real-life conditions and are increasingly popular among practitioners. In this paper, methodological aspects of studies based on clinical routine data are discussed. Important limitations and considerations as well as unique strengths of these types of studies are indicated and exemplarily demonstrated in a recent real-case study based on clinical routine data. In addition two simulation studies reveal the impact of bias in studies based on clinical routine data on the type I error rate and false decision rate in favor of the inferior intervention. It is concluded that correctly analyzing clinical routine data yields a valuable addition to clinical research; however, as a result of a lack of statistical foundation, internal validity, and comparability, generalizing results and inferring properties derived from clinical routine data to all patients of interest has to be considered with extreme caution. Grünenthal GmbH.

  4. Context based support for Clinical Reasoning

    DEFF Research Database (Denmark)

    Vilstrup Pedersen, Klaus

    2004-01-01

    In many areas of the medical domain, the decision process i.e. reasoning, involving health care professionals is distributed, cooperative and complex. Computer based decision support systems has usually been focusing on the outcome of the decision making and treated it as a single task. In this p...

  5. It's Elementary: Expanding the Use of School-Based Clinics

    Science.gov (United States)

    Lear, Julia Graham

    2007-01-01

    Governor Arnold Schwarzenegger has declared his intention to open health centers in 500 elementary schools across the state, which would bring the total number of such school-based clinics to 646. This initiative builds on California's 30-year history of using the school setting to increase access to care for children, improve clinical outcomes,…

  6. Post-Approval Studies

    Data.gov (United States)

    U.S. Department of Health & Human Services — The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a...

  7. Software development for ACR-approved phantom-based nuclear medicine tomographic image quality control with cross-platform compatibility

    Science.gov (United States)

    Oh, Jungsu S.; Choi, Jae Min; Nam, Ki Pyo; Chae, Sun Young; Ryu, Jin-Sook; Moon, Dae Hyuk; Kim, Jae Seung

    2015-07-01

    Quality control and quality assurance (QC/QA) have been two of the most important issues in modern nuclear medicine (NM) imaging for both clinical practices and academic research. Whereas quantitative QC analysis software is common to modern positron emission tomography (PET) scanners, the QC of gamma cameras and/or single-photon-emission computed tomography (SPECT) scanners has not been sufficiently addressed. Although a thorough standard operating process (SOP) for mechanical and software maintenance may help the QC/QA of a gamma camera and SPECT-computed tomography (CT), no previous study has addressed a unified platform or process to decipher or analyze SPECT phantom images acquired from various scanners thus far. In addition, a few approaches have established cross-platform software to enable the technologists and physicists to assess the variety of SPECT scanners from different manufacturers. To resolve these issues, we have developed Interactive Data Language (IDL)-based in-house software for crossplatform (in terms of not only operating systems (OS) but also manufacturers) analyses of the QC data on an ACR SPECT phantom, which is essential for assessing and assuring the tomographical image quality of SPECT. We applied our devised software to our routine quarterly QC of ACR SPECT phantom images acquired from a number of platforms (OS/manufacturers). Based on our experience, we suggest that our devised software can offer a unified platform that allows images acquired from various types of scanners to be analyzed with great precision and accuracy.

  8. An evidence-based guide to clinical instruction in audiology.

    Science.gov (United States)

    Mormer, Elaine; Palmer, Catherine; Messick, Cheryl; Jorgensen, Lindsey

    2013-05-01

    A significant portion of the AuD curriculum occurs in clinical settings outside the classroom. Expert clinicians, employed within and outside of the university, are called upon to provide this clinical education. Most have had little or no formal training in clinical teaching yet face pedagogical and logistical challenges when simultaneously providing clinical service and teaching. Training to provide optimal methods and approaches to clinical instruction should be based on research evidence; however, there is a paucity of research in this area within the audiology discipline. This article provides a review of literature supplying evidence for important concepts, elements, and approaches to the clinical instruction process. Additionally, we provide readers with some practical tools with which to facilitate application of optimal clinical teaching principles. We conducted a systematic review of literature on clinical education in audiology and across a wide array of health professions. Through the use of content analysis we identified four elements of the clinical teaching process most critical in examining optimal practices. The elements identified as critical to positive clinical learning outcomes include the establishment of mutual expectations and goals; structured content and delivery of feedback; establishment of a positive instructor/student relationship; and questioning strategies that lead to the development of critical thinking skills. Many disciplines outside of audiology demonstrate robust research activity related to understanding and optimizing the clinical education process. The application of a number of evidence-based clinical teaching principles should allow us to improve student outcomes in audiology. Researchers in our field might consider if and how we should develop our own research literature in clinical education. American Academy of Audiology.

  9. Concept-Based Learning in Clinical Experiences: Bringing Theory to Clinical Education for Deep Learning.

    Science.gov (United States)

    Nielsen, Ann

    2016-07-01

    Concept-based learning is used increasingly in nursing education to support the organization, transfer, and retention of knowledge. Concept-based learning activities (CBLAs) have been used in clinical education to explore key aspects of the patient situation and principles of nursing care, without responsibility for total patient care. The nature of best practices in teaching and the resultant learning are not well understood. The purpose of this multiple-case study research was to explore and describe concept-based learning in the context of clinical education in inpatient settings. Four clinical groups (each a case) were observed while they used CBLAs in the clinical setting. Major findings include that concept-based learning fosters deep learning, connection of theory with practice, and clinical judgment. Strategies used to support learning, major teaching-learning foci, and preconditions for concept-based teaching and learning will be described. Concept-based learning is promising to support integration of theory with practice and clinical judgment through application experiences with patients. [J Nurs Educ. 2016;55(7):365-371.]. Copyright 2016, SLACK Incorporated.

  10. Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical data

    Directory of Open Access Journals (Sweden)

    Strech Daniel

    2012-07-01

    Full Text Available Abstract For the protection of commercial interests, licensing bodies such as the EMA and health technology assessment institutions such as NICE restrict full access to unpublished evidence. Their respective policies on data transparency, however, lack a systematic account of (1 what kinds of commercial interests remain relevant after market approval has been granted, (2 what the specific types of public interest are that may override these commercial interests post approval, and, most importantly, (3 what criteria guide the trade-off between public interest and legitimate measures for the protection of commercial interest. Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.

  11. Semantically based clinical TCM telemedicine systems

    CERN Document Server

    Wong, Allan K Y; Lin, Wilfred W K; Dillon, Tharam S; Chang, Elizabeth J

    2015-01-01

    Recent years have seen the development of two significant trends namely: the adoption of some Traditional Chinese Medicine Practices into mainstream Allopathic Western Medicine and the advent of the internet and broad band networks leading to an increased interest in the use of Telemedicine to deliver medical services. In this book, we see the convergence of these two trends leading to a semantically-based TCM Telemedicine system that utilizes an ontology to provide sharable knowledge in the TCM realm to achieve this. The underpinning research required the development of a three-layer architecture and an Ontology of the TCM knowledge. As TCM knowledge like all medical knowledge is not frozen in time it was important to develop an approach that would allow evolution of the Ontology when new evidence became available. In order for the system to be practically grounded it was important to work with an industry partner PuraPharm Group/HerbMiners Informatics Limited. This partnership was initiated through Professo...

  12. Respiratory clinical guidelines inform ward-based nurses' clinical skills and knowledge required for evidence-based care.

    Science.gov (United States)

    Johnson, Alisha M; Smith, Sheree M S

    2016-09-01

    Respiratory clinical guidelines provide clinicians with evidence-based guidance for practice. Clinical guidelines also provide an opportunity to identify the knowledge and technical and non-technical skills required by respiratory ward-based registered nurses. The aim of this review was to use a systematic process to establish the core technical and non-technical skills and knowledge identified in evidence-based clinical guidelines that enable the care of hospitalised adult respiratory patients. 17 guidelines were identified in our systematic review. The quality assessment demonstrated variability in these guidelines. Common core knowledge and technical and non-technical skills were identified. These include pathophysiology, understanding of physiological measurements and monitoring, education, counselling, and ward and patient management. The knowledge and skills extracted from respiratory clinical guidelines may inform a curriculum for ward-based respiratory nursing to ensure optimal care of adult patients.

  13. Evidence Based Dental Care: Integrating Clinical Expertise with Systematic Research

    OpenAIRE

    2014-01-01

    Clinical dentistry is becoming increasingly complex and our patients more knowledgeable. Evidence-based care is now regarded as the “gold standard” in health care delivery worldwide. The basis of evidence based dentistry is the published reports of research projects. They are, brought together and analyzed systematically in meta analysis, the source for evidence based decisions. Activities in the field of evidence-based dentistry has increased tremendously in the 21st century, more and more p...

  14. Community based clinical program: the Medunsa physiotherapy students` experience

    Directory of Open Access Journals (Sweden)

    N. P. Taukobong

    2004-02-01

    Full Text Available Backgound: The aim of community based clinical training is tproduce graduates who are responsive to the health needs of their communit It is envisaged that upon completion of training graduates would go back an serve their respective communities following exposure to community need Program evaluation should therefore allow students to express the inadequacie and strengths of the program.Aim: To evaluate the community-based clinical program through student's experiences.Methodology: A qualitative research design was used. End of block students reports for both third (8 and fourth (15 year physiotherapy students (n = 23 were used to collect the data. Responses in the reports were grouped into the following categories for purpose of data analysis: feeling about the block, suggestion/s and supervision.Results: The students described the community based clinical program as an unique learning experience which equipped them with the understanding of life within communities. Sixty five percent (65% expressed satisfaction with the supervision given. The main complaints were amounts of paper work involved and clinical workload.Conclusion: The student's experiences indicated that the community-based clinical program within the MEDUNSA physiotherapy department realizes the goal of community-based clinical training as determined by WHO, except for inclusion of some multi-professional approaches and adaptation of the supervision provided.

  15. Recognizing Disjoint Clinical Concepts in Clinical Text Using Machine Learning-based Methods

    Science.gov (United States)

    Tang, Buzhou; Chen, Qingcai; Wang, Xiaolong; Wu, Yonghui; Zhang, Yaoyun; Jiang, Min; Wang, Jingqi; Xu, Hua

    2015-01-01

    Clinical concept recognition (CCR) is a fundamental task in clinical natural language processing (NLP) field. Almost all current machine learning-based CCR systems can only recognize clinical concepts of consecutive words (called consecutive clinical concepts, CCCs), but can do nothing about clinical concepts of disjoint words (called disjoint clinical concepts, DCCs), which widely exist in clinical text. In this paper, we proposed two novel types of representations for disjoint clinical concepts, and applied two state-of-the-art machine learning methods to recognizing consecutive and disjoint concepts. Experiments conducted on the 2013 ShARe/CLEF challenge corpus showed that our best system achieved a “strict” F-measure of 0.803 for CCCs, a “strict” F-measure of 0.477 for DCCs, and a “strict” F-measure of 0.783 for all clinical concepts, significantly higher than the baseline systems by 4.2% and 4.1% respectively. PMID:26958258

  16. Assessment of Clinical Competence: Written and Computer-Based Simulations.

    Science.gov (United States)

    Swanson, David B.; And Others

    1987-01-01

    Literature concerning the validity and reliability of both written and computer-based simulations in assessing clinical competence in the health professions is reviewed, and suggestions are given for the improvement of the psychometric qualities of simulation-based tests. (MSE)

  17. Obinutuzumab: first global approval.

    Science.gov (United States)

    Cameron, Fiona; McCormack, Paul L

    2014-01-01

    Obinutuzumab (Gazyva™) is an intravenously administered, humanized and glycoengineered, type II anti-CD20 monoclonal antibody for the treatment of B-cell malignancies. It is approved in the US for use in combination with chlorambucil for the first-line treatment of chronic lymphocytic leukaemia (CLL), and has been filed for approval in the EU in this indication. The antibody is based on GlycArt Biotechnology's (later Roche Glycart AG) proprietary GlycoMAb® technology, which uses glycoengineered antibodies that specifically increase antibody-dependent cellular cytotoxicity and thereby increase immune-mediated target cell death. Obinutuzumab is a type II anti-CD20 antibody that induces enhanced direct cell death. The monoclonal antibody is in worldwide phase III development with Roche and its subsidiaries, Genentech and Chugai Pharmaceutical, as well as Biogen Idec, for diffuse large B-cell lymphoma and non-Hodgkin's lymphoma generally, and is also in phase III development in countries outside of the US and EU for CLL.

  18. Nelfinavir: fourth protease inhibitor approved.

    Science.gov (United States)

    1997-01-01

    The Food and Drug Administration (FDA) has granted accelerated approval to nelfinavir in both adult and pediatric formulations. Agouron, the manufacturer, used innovative computerized drug design techniques to discover, design, and refine the nelfinavir molecule. Nelfinavir is marketed under the trade name Viracept, and costs $5,000 per year. Early clinical trials find it to be as powerful as the other protease inhibitors, but with a different resistance profile. The drug has relatively few drug indications; however, several compounds have been contraindicated.

  19. Applying extracellular vesicles based therapeutics in clinical trials

    DEFF Research Database (Denmark)

    Lener, Thomas; Gimona, Mario; Aigner, Ludwig

    2015-01-01

    EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential....... The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether....... In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME...

  20. A simple versatile solution for collecting multidimensional clinical data based on the CakePHP web application framework.

    Science.gov (United States)

    Biermann, Martin

    2014-04-01

    Clinical trials aiming for regulatory approval of a therapeutic agent must be conducted according to Good Clinical Practice (GCP). Clinical Data Management Systems (CDMS) are specialized software solutions geared toward GCP-trials. They are however less suited for data management in small non-GCP research projects. For use in researcher-initiated non-GCP studies, we developed a client-server database application based on the public domain CakePHP framework. The underlying MySQL database uses a simple data model based on only five data tables. The graphical user interface can be run in any web browser inside the hospital network. Data are validated upon entry. Data contained in external database systems can be imported interactively. Data are automatically anonymized on import, and the key lists identifying the subjects being logged to a restricted part of the database. Data analysis is performed by separate statistics and analysis software connecting to the database via a generic Open Database Connectivity (ODBC) interface. Since its first pilot implementation in 2011, the solution has been applied to seven different clinical research projects covering different clinical problems in different organ systems such as cancer of the thyroid and the prostate glands. This paper shows how the adoption of a generic web application framework is a feasible, flexible, low-cost, and user-friendly way of managing multidimensional research data in researcher-initiated non-GCP clinical projects. Copyright © 2014 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  1. Marketing Approval of Ethical Kampo Medicines.

    Science.gov (United States)

    Hakamatsuka, Takashi

    2017-01-01

     Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.

  2. Toward an Ontology-Based Framework for Clinical Research Databases

    Science.gov (United States)

    Kong, Y. Megan; Dahlke, Carl; Xiang, Qun; Qian, Yu; Karp, David; Scheuermann, Richard H.

    2010-01-01

    Clinical research includes a wide range of study designs from focused observational studies to complex interventional studies with multiple study arms, treatment and assessment events, and specimen procurement procedures. Participant characteristics from case report forms need to be integrated with molecular characteristics from mechanistic experiments on procured specimens. In order to capture and manage this diverse array of data, we have developed the Ontology-Based eXtensible conceptual model (OBX) to serve as a framework for clinical research data in the Immunology Database and Analysis Portal (ImmPort). By designing OBX around the logical structure of the Basic Formal Ontology (BFO) and the Ontology for Biomedical Investigations (OBI), we have found that a relatively simple conceptual model can represent the relatively complex domain of clinical research. In addition, the common framework provided by BFO makes it straightforward to develop data dictionaries based on reference and application ontologies from the OBO Foundry. PMID:20460173

  3. Evidence-Based Clinical Significance in Health Care: Toward an Inferential Analysis of Clinical Relevance

    Directory of Open Access Journals (Sweden)

    Mahsa Dousti

    2011-09-01

    Full Text Available Evidence-based dental practice requires the developmment and evaluation of protocols that en-sure translational effectiveness: that is, the efficient incorporation of the best available efficacy and effec-tiveness findings in specific clinical dentistry settings and environments. Evidence-based dentistry predi-cates the synthesis of research for obtaining the best available evidence in a validated, stringent, systematic and unbiased fashion. Research synthesis is now established as a science in its own right, precisely because it adheres to the scientific process that is driven by a research question and a hypothesis, follows through clearly defined methodology and design, yielding quantifiable data that are analyzed statistically, and from which stringent statistical inferences are drawn. The conclusions from the protocol of research synthesis define the best available evidence, which is used in the process of evidence-based revision of clinical practice guidelines. One important hurdle of the process of applying research synthesis in evidence-based dentistry lies in the fact that the statistical inferences produced by research must be translated into clinical relevance. Here, we present a model to circumvent this limitation by means of text analysis/mining protocols, which could lead the path toward a novel, valid and reliable ap-proach for the inferential analysis of clinical relevance.

  4. Clinical consequences of PCR based diagnosis of intestinal parasitic infections

    NARCIS (Netherlands)

    Rijsman, Lucas H; Monkelbaan, Jan F; Kusters, Johannes G

    The implementation of Polymerase Chain Reaction (PCR) based diagnostics of intestinal protozoa have led to higher sensitivity and (subtype) specificity, more convenient sampling and the possibility for high-throughput screening. An increasing number of clinical laboratories use PCR for routine

  5. Embedding trials in evidence-based clinical practice

    NARCIS (Netherlands)

    Oude Rengerink, K.

    2014-01-01

    This thesis presents a number of research projects centred on ‘evidence-based medicine’. It consists of two parts. Part 1 focuses on improving recruitment of the necessary number of patients in clinical trials, as this is the major problem while evaluating the effectiveness of interventions in healt

  6. Clinical consequences of PCR based diagnosis of intestinal parasitic infections

    NARCIS (Netherlands)

    Rijsman, Lucas H; Monkelbaan, Jan F; Kusters, Johannes G

    2016-01-01

    The implementation of Polymerase Chain Reaction (PCR) based diagnostics of intestinal protozoa have led to higher sensitivity and (subtype) specificity, more convenient sampling and the possibility for high-throughput screening. An increasing number of clinical laboratories use PCR for routine detec

  7. Embedding trials in evidence-based clinical practice

    NARCIS (Netherlands)

    Oude Rengerink, K.

    2014-01-01

    This thesis presents a number of research projects centred on ‘evidence-based medicine’. It consists of two parts. Part 1 focuses on improving recruitment of the necessary number of patients in clinical trials, as this is the major problem while evaluating the effectiveness of interventions in healt

  8. Clinical consequences of PCR based diagnosis of intestinal parasitic infections

    NARCIS (Netherlands)

    Rijsman, Lucas H; Monkelbaan, Jan F|info:eu-repo/dai/nl/344499383; Kusters, Johannes G

    2016-01-01

    The implementation of Polymerase Chain Reaction (PCR) based diagnostics of intestinal protozoa have led to higher sensitivity and (subtype) specificity, more convenient sampling and the possibility for high-throughput screening. An increasing number of clinical laboratories use PCR for routine detec

  9. 28 CFR 549.51 - Approval procedures.

    Science.gov (United States)

    2010-07-01

    ... SERVICES Plastic Surgery § 549.51 Approval procedures. The Clinical Director shall consider individually any request from an inmate or a BOP medical consultant. (a) In circumstances where plastic surgery is... the Clinical Director recommends plastic surgery for the good order and security of the...

  10. Clinical patterns of primary stabbing headache: a single clinic-based prospective study.

    Science.gov (United States)

    Kim, Dong Yeop; Lee, Mi Ji; Choi, Hyun Ah; Choi, Hanna; Chung, Chin-Sang

    2017-12-01

    The clinical features and disease courses of primary stabbing headache (PSH) are diverse. We aimed to identify distinct clinical patterns of PSH. We prospectively screened consecutive first-visit patients who presented with stabbing headache at the Samsung Medical Centre Headache Clinic from June 2015 to March 2016. Demographics, headache characteristics, and disease courses were prospectively evaluated. After discerning factors related to the chronicity at the time of presentation, clinical patterns were identified based on the frequency (daily vs. intermittent), clinical course (remitted or not), and total disease duration (3 months). In the 65 patients with PSH included in this study, monophasic (n = 31), intermittent (n = 17), and chronic daily (n = 12) patterns were identified. The median disease durations were 9 days for monophasic PSH, 9 months for chronic daily PSH, and 2 years for intermittent PSH. The features of monophasic PSH were greater severity, single and side-locked locations, more attacks per day, daily occurrence, and good treatment response. Chronic daily PSH was associated with female predominance, longer-lasting stabs, and multiple or migrating locations on bilateral or alternating sides. The characteristics of intermittent PSH included female predominance and sporadic stabs with less intensity. Our study demonstrated distinct clinical patterns of PSH. In addition to help early recognition of disease, our findings suggest different pathophysiologic mechanisms. Future prospective studies are required to reveal the etiologies of these different PSH patterns and their optimal treatment strategies.

  11. Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

    Science.gov (United States)

    Ghobadi, Comeron W; Hayman, Emily L; Finkle, Joshua H; Walter, Jessica R; Xu, Shuai

    2017-01-01

    The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality of the pivotal trial was determined using the Quality Assessment of Diagnostic Accuracy Studies tool. Twenty-three class III radiologic device approvals were identified, with breast imaging accounting for 16 (70%) and computer-aided detection software accounting for 9 (39%) approvals. The median premarket approval time was 475 days (range, 180-1,116). Twenty-one devices were approved on the basis of multireader, multicenter studies, one on the basis of a randomized controlled trial, and one on the basis of a preclinical technical equivalence trial. The median number of patients per pivotal trial was 201 (range, 25-3,946). Twenty-six of the 34 pivotal trials (76%) had at least one methodologic bias. Breast imaging devices had a greater number of patients per pivotal trial (P = .009) and more prospective studies. With regard to all modalities, increased time to device approval correlated with weaker trial quality (r = 0.600, P < .001). Radiologic devices are largely approved by multireader, multicenter studies, the recommended standard for assessing diagnostic technologies. Given that radiologic devices play a key role in modern medicine, further efforts should be made to increase transparency of clinical data leading to approval. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  12. Evidence-based clinical practice guidelines for cholelithiasis 2016.

    Science.gov (United States)

    Tazuma, Susumu; Unno, Michiaki; Igarashi, Yoshinori; Inui, Kazuo; Uchiyama, Kazuhisa; Kai, Masahiro; Tsuyuguchi, Toshio; Maguchi, Hiroyuki; Mori, Toshiyuki; Yamaguchi, Koji; Ryozawa, Shomei; Nimura, Yuji; Fujita, Naotaka; Kubota, Keiichi; Shoda, Junichi; Tabata, Masami; Mine, Tetsuya; Sugano, Kentaro; Watanabe, Mamoru; Shimosegawa, Tooru

    2017-03-01

    Cholelithiasis is one of the commonest diseases in gastroenterology. Remarkable improvements in therapeutic modalities for cholelithiasis and its complications are evident. The Japanese Society of Gastroenterology has revised the evidence-based clinical practice guidelines for cholelithiasis. Forty-three clinical questions, for four categories-epidemiology and pathogenesis, diagnosis, treatments, and prognosis and complications-were selected, and a literature search was performed for the clinical questions with use of the MEDLINE, Cochrane, and Igaku Chuo Zasshi databases for the period between 1983 and June 2012. The guidelines were developed with use of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This article preferentially describes the clinical management of cholelithiasis and its complications. Following description of the diagnosis performed stepwise through imaging modalities, treatments of cholecystolithiasis, choledocholithiasis, and hepatolithiasis are introduced along with a flowchart. Since there have been remarkable improvements in endoscopic treatments and surgical techniques, the guidelines ensure flexibility in choices according to the actual clinical environment. The revised clinical practice guidelines are appropriate for use by clinicians in their daily practice.

  13. Toward clinical scholarship: promoting evidence-based practice in the clinical setting.

    Science.gov (United States)

    Mohide, E Ann; Coker, Esther

    2005-01-01

    Organizational interventions are being suggested to increase the rate of quality research dissemination and uptake. This article describes how one tertiary institution is using an evidence-based nursing (EBN) committee as an organizational strategy to shift its nursing culture toward clinical scholarship. A number of approaches and activities that have stimulated the movement toward evidence-based practice (EBP) are examined: organizational commitment to EBP, strategic positioning of the EBN committee within nursing's administrative structure, articulation of a mission, conceptualization of a model for EBN practice, learning on the job, selection and adoption of an evidence-based model for implementing change, marketing for a change in culture toward clinical scholarship, and other selected examples of projects undertaken by the committee. Action-oriented principles associated with committee experiences are related to the approaches and activities.

  14. Evidence-based practice guidelines--one way to enhance clinical practice.

    Science.gov (United States)

    Bailes, Barbara K

    2002-06-01

    Abdominoplasty and liposuction guidelines are just two of the guidelines that can be accessed and used to enhance patient care. Guidelines also can be used to increase your knowledge about many other health care topics. The NGC has approved guidelines for managing chronic pain, as well as guidelines on chronic diseases (e.g., diabetes mellitus, hypertension, chronic obstructive pulmonary disease). Many patients have chronic diseases, and you or your family members also may be affected by chronic disorders. These guidelines provide you with a quick overview of evidence-based treatment protocols. These guidelines are not a panacea for evidence-based practice, but using them is one way that perioperative nurses can enhance their clinical skills. Though not everyone has personal Internet access, most health care facilities do or can make access a reality. Other options include medical or public libraries. Then one simply has to access the NGC web site and join other professionals in improving the quality and timeliness of patient care.

  15. Evidence-based integrative medicine in clinical veterinary oncology.

    Science.gov (United States)

    Raditic, Donna M; Bartges, Joseph W

    2014-09-01

    Integrative medicine is the combined use of complementary and alternative medicine with conventional or traditional Western medicine systems. The demand for integrative veterinary medicine is growing, but evidence-based research on its efficacy is limited. In veterinary clinical oncology, such research could be translated to human medicine, because veterinary patients with spontaneous tumors are valuable translational models for human cancers. An overview of specific herbs, botanics, dietary supplements, and acupuncture evaluated in dogs, in vitro canine cells, and other relevant species both in vivo and in vitro is presented for their potential use as integrative therapies in veterinary clinical oncology. Published by Elsevier Inc.

  16. Restricted natural language based querying of clinical databases.

    Science.gov (United States)

    Safari, Leila; Patrick, Jon D

    2014-12-01

    To elevate the level of care to the community it is essential to provide usable tools for healthcare professionals to extract knowledge from clinical data. In this paper a generic translation algorithm is proposed to translate a restricted natural language query (RNLQ) to a standard query language like SQL (Structured Query Language). A special purpose clinical data analytics language (CliniDAL) has been introduced which provides scheme of six classes of clinical questioning templates. A translation algorithm is proposed to translate the RNLQ of users to SQL queries based on a similarity-based Top-k algorithm which is used in the mapping process of CliniDAL. Also a two layer rule-based method is used to interpret the temporal expressions of the query, based on the proposed temporal model. The mapping and translation algorithms are generic and thus able to work with clinical databases in three data design models, including Entity-Relationship (ER), Entity-Attribute-Value (EAV) and XML, however it is only implemented for ER and EAV design models in the current work. It is easy to compose a RNLQ via CliniDAL's interface in which query terms are automatically mapped to the underlying data models of a Clinical Information System (CIS) with an accuracy of more than 84% and the temporal expressions of the query comprising absolute times, relative times or relative events can be automatically mapped to time entities of the underlying CIS and to normalized temporal comparative values. The proposed solution of CliniDAL using the generic mapping and translation algorithms which is enhanced by a temporal analyzer component provides a simple mechanism for composing RNLQ for extracting knowledge from CISs with different data design models for analytics purposes. Copyright © 2014 Elsevier Inc. All rights reserved.

  17. Recently approved systemic therapies for acne vulgaris and rosacea.

    Science.gov (United States)

    Del Rosso, James Q

    2007-08-01

    Until recently, with the exception of oral isotretinoin for the treatment of severe recalcitrant nodular acne, systemic therapy for acne vulgaris and rosacea has been based on anecdotal support, clinical experience, and small clinical trials. Tetracycline derivatives are the predominant systemic agents that have been used for both disease states, prescribed in dose ranges that produce antibiotic activity. Anti-inflammatory dose doxycycline, a controlled-release (CR) 40-mg capsule formulation of doxycycline that is devoid of antibiotic activity when administered once daily, was US Food and Drug Administration (FDA)-approved for the treatment of inflammatory lesions (papules and pustules) of rosacea, based on large-scale phase 3 pivotal trials and long-term microbiologic and safety data. Also, an extended-release (ER) tablet formulation of minocycline was approved by the FDA for the treatment of inflammatory lesions of moderate to severe acne vulgaris in patients 12 years and older based on large-scale phase 3 clinical trials that evaluated efficacy and safety, dose-response analysis, and long-term data. This article discusses the studies and clinical applications related to the use of these agents.

  18. Drugs Approved for Hodgkin Lymphoma

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Hodgkin Lymphoma This page lists cancer drugs approved by ... that are not listed here. Drugs Approved for Hodgkin Lymphoma Adcetris (Brentuximab Vedotin) Ambochlorin (Chlorambucil) Amboclorin (Chlorambucil) ...

  19. Drugs Approved for Lung Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Lung Cancer This page lists cancer drugs approved by the ... listed here. Drugs Approved for Non-Small Cell Lung Cancer Abitrexate (Methotrexate) Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation) ...

  20. Drugs Approved for Thyroid Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Thyroid Cancer This page lists cancer drugs approved by the ... that are not listed here. Drugs Approved for Thyroid Cancer Cabozantinib-S-Malate Caprelsa (Vandetanib) Cometriq (Cabozantinib-S-Malate) Doxorubicin ...

  1. A quality assessment tool for markup-based clinical guidelines.

    Science.gov (United States)

    Shalom, Erez; Shahar, Yuval; Taieb-Maimon, Meirav; Lunenfeld, Eitan

    2008-11-06

    We introduce a tool for quality assessment of procedural and declarative knowledge. We developed this tool for evaluating the specification of mark-up-based clinical GLs. Using this graphical tool, the expert physician and knowledge engineer collaborate to perform scoring, using pre-defined scoring scale, each of the knowledge roles of the mark-ups, comparing it to a gold standard. The tool enables scoring the mark-ups simultaneously at different sites by different users at different locations.

  2. Relevance of guideline-based ICD indications to clinical practice.

    Science.gov (United States)

    Al-Jefairi, Nora; Burri, Haran

    2014-01-01

    The implantable cardioverter-defibrillator (ICD) has established itself as life-saving therapy in patients at risk for sudden cardiac death. Remarkable technological advances have made ICDs easier and safer to implant, with improved therapeutic and diagnostic functions and reduced morbidity. Guidelines on ICD indications have been proposed by American and European scientific societies since a number of years, based upon trials and expert opinion. In the context of variable economic and political constraints, it is questionable whether these guidelines may be applied to all settings. This review discusses the guideline-based indications, critically examines their applicability to clinical practice, and discusses alternatives to ICD therapy.

  3. Evaluation of Porcine Pancreatic Islets Transplanted in the Kidney Capsules of Diabetic Mice Using a Clinically Approved Superparamagnetic Iron Oxide (SPIO) and a 1.5T MR Scanner

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hoe Suk; Kim, Hyoung Su; Park, Kyong Soo; Moon, Woo Kyung [Seoul National University Hospital, Seoul (Korea, Republic of)

    2010-12-15

    To evaluate transplanted porcine pancreatic islets in the kidney capsules of diabetic mice using a clinically approved superparamagnetic iron oxide (SPIO) and a 1.5T MR scanner. Various numbers of porcine pancreatic islets labeled with Resovist, a carboxydextran-coated SPIO, were transplanted into the kidney capsules of normal mice and imaged with a 3D FIESTA sequence using a 1.5T clinical MR scanner. Labeled (n = 3) and unlabeled (n = 2) islets were transplanted into the kidney capsules of streptozotocin-induced diabetic mice. Blood glucose levels and MR signal intensities were monitored for 30 days post-transplantation. There were no significant differences in viability or insulin secretion between labeled and unlabeled islets. A strong correlation ({gamma} {sup 2} > 0.94) was evident between the number of transplanted islets and T{sub 2} relaxation times quantified by MRI. Transplantation with labeled or unlabeled islets helped restore normal sustained glucose levels in diabetic mice, and nephrectomies induced the recurrence of diabetes. The MR signal intensity of labeled pancreatic islets decreased by 80% over 30 days. The transplantation of SPIO-labeled porcine islets into the kidney capsule of diabetic mice allows to restore normal glucose levels, and these islets can be visualized and quantified using a 1.5T clinical MR scanner

  4. Trends in global approvals of biotech crops (1992–2014)

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    ABSTRACT With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992–2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits. PMID:26039675

  5. Trends in global approvals of biotech crops (1992-2014).

    Science.gov (United States)

    Aldemita, Rhodora R; Reaño, Ian Mari E; Solis, Renando O; Hautea, Randy A

    2015-01-01

    With the increasing number of genetically modified (GM) events, traits, and crops that are developed to benefit the global population, approval of these technologies for food, feed, cultivation and import in each country may vary depending on needs, demand and trade interest. ISAAA established a GMO Approval Database to document global approvals of biotech crops. GM event name, crops, traits, developer, year of approval for cultivation, food/feed, import, and relevant dossiers were sourced from credible government regulatory websites and biosafety clearinghouses. This paper investigates the trends in GM approvals for food, feed and cultivation based on the number of approving countries, GM crops, events, and traits in the last 23 y (1992-2014), rationale for approval, factors influencing approvals, and their implications in GM crop adoption. Results show that in 2014, there was an accumulative increase in the number of countries granting approvals at 29 (79% developing countries) for commercial cultivation and 31 (70% developing countries) for food and 19 (80% developing developing) for feed; 2012 had the highest number of approving countries and cultivation approvals; 2011 had the highest number of country approvals for feed, and 2014 for food approvals. Herbicide tolerance trait had the highest events approved, followed by insect tolerance traits. Approvals for food product quality increased in the second decade. Maize had the highest number of events approved (single and stacked traits), and stacked traits product gradually increased which is already 30% of the total trait approvals. These results may indicate understanding and acceptance of countries to enhance regulatory capability to be able to benefit from GM crop commercialization. Hence, the paper provided information on the trends on the growth of the GM crop industry in the last 23 y which may be vital in predicting future GM crops and traits.

  6. 基于GIS的户外广告审批系统的设计与实现%Design and Implementation of GIS-Based Outdoor Advertising Approval System

    Institute of Scientific and Technical Information of China (English)

    智升翠; 高洪主; 尤红

    2011-01-01

    "户外广告审报系统"引入了GIS技术用以户外广告的审批,实现了户外广告审批与管理的无纸化办公,提高了户外广告管理部门的工作效率,对"数字哈尔滨"建设具有深远意义。%"Outdoor advertising approval system" based on GIS technology is applied for approval of outdoor advertising.It achieved a paperless office for outdoor advertising approval and management,improved the work of outdoor advertising management efficiency,and had far-reaching significance for "Digital Harbin" construction.

  7. Movement-Based Priming: Clinical Applications and Neural Mechanisms.

    Science.gov (United States)

    Stoykov, Mary Ellen; Corcos, Daniel Montie; Madhavan, Sangeetha

    2017-01-01

    Priming can be described as behavior change generated by preceding stimuli. Although various types of priming have been long studied in the field of psychology, priming that targets motor cortex is a relatively new topic of research in the fields of motor control and rehabilitation. In reference to a rehabilitation intervention, priming is categorized as a restorative approach. There are a myriad of possible priming approaches including noninvasive brain stimulation, motor imagery, and sensory-based priming, to name a few. The authors report on movement-based priming which, compared to other priming types, is less frequently examined and under reported. Movement-based priming includes, but is not limited to, bilateral motor priming, unilateral priming, and aerobic exercise. Clinical and neural mechanistic aspects of movement-based priming techniques are explored.

  8. Repurposing of approved cardiovascular drugs.

    Science.gov (United States)

    Ishida, Junichi; Konishi, Masaaki; Ebner, Nicole; Springer, Jochen

    2016-09-20

    Research and development of new drugs requires both long time and high costs, whereas safety and tolerability profiles make the success rate of approval very low. Drug repurposing, applying known drugs and compounds to new indications, has been noted recently as a cost-effective and time-unconsuming way in developing new drugs, because they have already been proven safe in humans. In this review, we discuss drug repurposing of approved cardiovascular drugs, such as aspirin, beta-blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, cardiac glycosides and statins. Regarding anti-tumor activities of these agents, a number of experimental studies have demonstrated promising pleiotropic properties, whereas all clinical trials have not shown expected results. In pathological conditions other than cancer, repurposing of cardiovascular drugs is also expanding. Numerous experimental studies have reported possibilities of drug repurposing in this field and some of them have been tried for new indications ('bench to bedside'), while unexpected results of clinical studies have given hints for drug repurposing and some unknown mechanisms of action have been demonstrated by experimental studies ('bedside to bench'). The future perspective of experimental and clinical studies using cardiovascular drugs are also discussed.

  9. [Clinical features and comprehensive treatment of skull base osteosarcoma].

    Science.gov (United States)

    Hu, Ke; Wan, Jinghai; Ni, Song; Li, Xueji; Liu, Shaoyan; Meng, Xiaoli; Qian, Haipeng

    2015-05-01

    To analyze the clinical features and treatment of skull base osteosarcoma. The clinical data of 18 patients with skull base osteosarcoma, who were admitted to the CAMS Cancer Hospital from January 2005 to November 2013, were retrospectively analyzed. The patients were followed up by telephone, outpatient review and other means. Fifteen patients were followed up, 4 cases received surgery only, and 11 cases received surgery with adjuvant chemotherapy and/or radiotherapy. Kaplan-Meier survival curve analysis was used to analyze the clinical data and Log rank method was used for verification. Nine patients died among the 15 patients who were followed up for 3-103 months (mean 25.0 months): seven patients died of local recurrence, and two patients died of distant metastasis, and six patients were still alive. Four patients received surgery only, with a median survival time of 25.0 months, and 11 patients received comprehensive treatment, with a median survival time of 47.0 months (P = 0.02). Five patients received sub-total resection, with a mean survival time of 47.0 months, and 10 patients received total resection, with a mean survival time of 45.0 months (P = 0.37). The 1- and 2-year recurrence rates were 46.6% and 68.9%, respectively. The overall 1-, 2-, 3- and 5-year survival rates were 82.4%, 61.8%, 36.0% and 36.0%, respectively, with a median survival time of 30.0 months. To compare the long bone and head and neck osteosarcoma with skull base osteosarcoma, the skull base osteosarcoma has a lower total resection rate, a higher recurrence rate, and a poorer prognosis. Radical surgery and comprehensive treatment are appropriate for skull base osteosarcoma.

  10. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North America,...

  11. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North...

  12. FWS Approved Acquisition Boundaries

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This data layer depicts the external boundaries of lands and waters that are approved for acquisition by the U.S. Fish and Wildlife Service (USFWS) in North America,...

  13. Drugs Approved for Leukemia

    Science.gov (United States)

    This page lists cancer drugs approved by the FDA for use in leukemia. The drug names link to NCI's Cancer Drug Information summaries. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  14. Drugs Approved for Retinoblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for retinoblastoma. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  15. Drugs Approved for Neuroblastoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for neuroblastoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  16. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  17. Premarket Approvals (PMA)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...

  18. An economic comparison of hospital-based and community-based glaucoma clinics

    Science.gov (United States)

    Sharma, A; Jofre-Bonet, M; Panca, M; Lawrenson, J G; Murdoch, I

    2012-01-01

    Introduction We have established one model for community care of glaucoma clinic patients. Community optometrists received training and accreditation in glaucoma care. Once qualified they alternated between running half day glaucoma clinics in their own High Street practices and assisting in a hospital-based glaucoma clinic session. This paper reports the cost of this model. Methods Micro-costing was undertaken for the hospital clinic. A consensus meeting was held to agree costs for community clinics involving all optometrists in the project along with representatives of the multiple chain optometry practices who had participated. Costs to patients both indirect and direct were calculated following structured interviews of 197 patients attending hospital clinics and 194 attending community clinics. Results The estimated cost per patient attendance to the hospital clinic was £63.91 and the estimated cost per attendance to the community clinic was £145.62. For patients the combined direct and indirect cost to attend the hospital clinic was £6.15 and the cost to attend the community clinic £5.91. Discussion The principal reason for the higher cost in the community clinic was higher overhead costs in the community. Re-referral to the hospital system only occurred for 9% of patients and was not a large contribution to the increased cost. Time requested to next appointment was similar for the two clinics. Sensitivity analysis shows a strong effect of increasing patients seen per clinic. It would, however, require 25 patients to be seen per clinician per day in the community in order to make the costs comparable. PMID:22562188

  19. Clinical TVA-based studies: a general review

    Science.gov (United States)

    Habekost, Thomas

    2015-01-01

    In combination with whole report and partial report tasks, the theory of visual attention (TVA) can be used to estimate individual differences in five basic attentional parameters: the visual processing speed, the storage capacity of visual short-term memory, the perceptual threshold, the efficiency of top–down selectivity, and the spatial bias of attentional weighting. TVA-based assessment has been used in about 30 studies to investigate attentional deficits in a range of neurological and psychiatric conditions: (a) neglect and simultanagnosia, (b) reading disturbances, (c) aging and neurodegenerative diseases, and most recently (d) neurodevelopmental disorders. The article introduces TVA based assessment, discusses its methodology and psychometric properties, and reviews the progress made in each of the four research fields. The empirical results demonstrate the general usefulness of TVA-based assessment for many types of clinical neuropsychological research. The method’s most important qualities are cognitive specificity and theoretical grounding, but it is also characterized by good reliability and sensitivity to minor deficits. The review concludes by pointing to promising new areas for clinical TVA-based research. PMID:25852607

  20. Clinical TVA-based studies: a general review.

    Science.gov (United States)

    Habekost, Thomas

    2015-01-01

    In combination with whole report and partial report tasks, the theory of visual attention (TVA) can be used to estimate individual differences in five basic attentional parameters: the visual processing speed, the storage capacity of visual short-term memory, the perceptual threshold, the efficiency of top-down selectivity, and the spatial bias of attentional weighting. TVA-based assessment has been used in about 30 studies to investigate attentional deficits in a range of neurological and psychiatric conditions: (a) neglect and simultanagnosia, (b) reading disturbances, (c) aging and neurodegenerative diseases, and most recently (d) neurodevelopmental disorders. The article introduces TVA based assessment, discusses its methodology and psychometric properties, and reviews the progress made in each of the four research fields. The empirical results demonstrate the general usefulness of TVA-based assessment for many types of clinical neuropsychological research. The method's most important qualities are cognitive specificity and theoretical grounding, but it is also characterized by good reliability and sensitivity to minor deficits. The review concludes by pointing to promising new areas for clinical TVA-based research.

  1. Deterministic versus evidence-based attitude towards clinical diagnosis.

    Science.gov (United States)

    Soltani, Akbar; Moayyeri, Alireza

    2007-08-01

    Generally, two basic classes have been proposed for scientific explanation of events. Deductive reasoning emphasizes on reaching conclusions about a hypothesis based on verification of universal laws pertinent to that hypothesis, while inductive or probabilistic reasoning explains an event by calculation of some probabilities for that event to be related to a given hypothesis. Although both types of reasoning are used in clinical practice, evidence-based medicine stresses on the advantages of the second approach for most instances in medical decision making. While 'probabilistic or evidence-based' reasoning seems to involve more mathematical formulas at the first look, this attitude is more dynamic and less imprisoned by the rigidity of mathematics comparing with 'deterministic or mathematical attitude'. In the field of medical diagnosis, appreciation of uncertainty in clinical encounters and utilization of likelihood ratio as measure of accuracy seem to be the most important characteristics of evidence-based doctors. Other characteristics include use of series of tests for refining probability, changing diagnostic thresholds considering external evidences and nature of the disease, and attention to confidence intervals to estimate uncertainty of research-derived parameters.

  2. Clinical TVA-based studies: a general review

    Directory of Open Access Journals (Sweden)

    Thomas eHabekost

    2015-03-01

    Full Text Available In combination with whole report and partial report tasks, the Theory of Visual Attention (TVA can be used to estimate individual differences in five basic attentional parameters: The visual processing speed, the storage capacity of visual short-term memory, the perceptual threshold, the efficiency of top-down selectivity, and the spatial bias of attentional weighting. TVA-based assessment has been used in about 30 studies to investigate attentional deficits in a range of neurological and psychiatric conditions: (a neglect and simultanagnosia, (b reading disturbances, (c aging and neurodegenerative diseases, and most recently (d neurodevelopmental disorders. The article introduces TVA based assessment, discusses its methodology and psychometric properties, and reviews the progress made in each of the four research fields. The empirical results demonstrate the general usefulness of TVA-based assessment for many types of clinical neuropsychological research. The method’s most important qualities are cognitive specificity and theoretical grounding, but it is also characterized by good reliability and sensitivity to minor deficits. The review concludes by pointing to promising new areas for clinical TVA-based research.

  3. A JAVA-based multimedia tool for clinical practice guidelines.

    Science.gov (United States)

    Maojo, V; Herrero, C; Valenzuela, F; Crespo, J; Lazaro, P; Pazos, A

    1997-01-01

    We have developed a specific language for the representation of Clinical Practice Guidelines (CPGs) and Windows C++ and platform independent JAVA applications for multimedia presentation and edition of electronically stored CPGs. This approach facilitates translation of guidelines and protocols from paper to computer-based flowchart representations. Users can navigate through the algorithm with a friendly user interface and access related multimedia information within the context of each clinical problem. CPGs can be stored in a computer server and distributed over the World Wide Web, facilitating dissemination, local adaptation, and use as a reference element in medical care. We have chosen the Agency for Health Care and Policy Research's heart failure guideline to demonstrate the capabilities of our tool.

  4. BioShaDock: a community driven bioinformatics shared Docker-based tools registry [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    François Moreews

    2015-12-01

    Full Text Available Linux container technologies, as represented by Docker, provide an alternative to complex and time-consuming installation processes needed for scientific software. The ease of deployment and the process isolation they enable, as well as the reproducibility they permit across environments and versions, are among the qualities that make them interesting candidates for the construction of bioinformatic infrastructures, at any scale from single workstations to high throughput computing architectures. The Docker Hub is a public registry which can be used to distribute bioinformatic software as Docker images. However, its lack of curation and its genericity make it difficult for a bioinformatics user to find the most appropriate images needed. BioShaDock is a bioinformatics-focused Docker registry, which provides a local and fully controlled environment to build and publish bioinformatic software as portable Docker images. It provides a number of improvements over the base Docker registry on authentication and permissions management, that enable its integration in existing bioinformatic infrastructures such as computing platforms. The metadata associated with the registered images are domain-centric, including for instance concepts defined in the EDAM ontology, a shared and structured vocabulary of commonly used terms in bioinformatics. The registry also includes user defined tags to facilitate its discovery, as well as a link to the tool description in the ELIXIR registry if it already exists. If it does not, the BioShaDock registry will synchronize with the registry to create a new description in the Elixir registry, based on the BioShaDock entry metadata. This link will help users get more information on the tool such as its EDAM operations, input and output types. This allows integration with the ELIXIR Tools and Data Services Registry, thus providing the appropriate visibility of such images to the bioinformatics community.

  5. Implementing security in computer based patient records clinical experiences.

    Science.gov (United States)

    Iversen, K R; Heimly, V; Lundgren, T I

    1995-01-01

    In Norway, organizational changes in hospitals and a stronger focus on patient safety have changed the way of organizing and managing paper based patient records. Hospital-wide patient records tend to replace department based records. Since not only clinicians, but also other non-medical staff have access to the paper records, they also have easy access to all the information which is available on a specific patient; such a system has obvious 'side effects' on privacy and security. Computer based patient records (CPRs) can provide the solution to this apparent paradox if the complex aspects of security, privacy, effectiveness, and user friendliness are focused on jointly from the outset in designing such systems. Clinical experiences in Norway show that it is possible to design patient record systems that provide a very useful tool for clinicians and other health care personnel (HCP) while fully complying with comprehensive security and privacy requirements.

  6. Teaching and learning based on peer review: a realistic approach in forensic sciences [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Ricardo Jorge Dinis-Oliveira

    2016-05-01

    Full Text Available Teaching and learning methods need a continuous upgrade in higher education. However it is also true that some of the modern methodologies do not reduce or prevent school failure. Perhaps the real limitation is the inability to identify the true reasons that may explain it or ignore/undervalue the problem. In our opinion, one of the current constraints of the teaching/learning process is the excess of and inadequate bibliography recommended by the teacher, which results in continuous student difficulties and waste of time in searching and selecting useful information. The need to change the paradigm of the teaching/learning process comes also from employers. They claim forensic experts armed with useful knowledge to face professional life. It is therefore mandatory to identify the new needs and opportunities regarding pedagogical methodologies. This article reflects on the recent importance of peer review in teaching/learning forensic sciences based on the last 10 years of pedagogical experience inseparably from the scientific activity.

  7. Ten practical, theory-based tips for clinical course planners

    DEFF Research Database (Denmark)

    Balslev, T.; Westphall, I.; Blichfeldt, S.

    2008-01-01

    A list of practical advice and examples are given based on the literature. E-learning with cliffhanger text-cases can activate prior knowledge, and selected examination skills can be trained with simulated patients. Patient video recordings can be used to train clinical reasoning skills, including...... pattern recognition and hypothetic-deductive approaches. Interactive approaches, for example, questioning, quizzes or buzz groups imply active involvement and participation. Quizzes and MCQ-testing can provide a formative 'check-up' on learning and point to gaps in understanding for the teachers...

  8. Do evidence-based guidelines change clinical practice patterns?

    DEFF Research Database (Denmark)

    Kessel, Line; Erngaard, Ditte; Flesner, Per;

    2017-01-01

    In 2013, the Danish Health and Medicines Authorities published a National Clinical Guideline on the treatment of age-related cataracts. The guideline provided evidence-based recommendations on the indication for cataract surgery, cataract surgery in patients with age-related macular degeneration...... sequential bilateral cataract surgery and on the postoperative check-up of patients. A questionnaire was sent to all members of the Danish Ophthalmological Society before and after publication of the guideline. The responses showed that the guideline had changed practice patterns so that surgeons were more...

  9. Clinical Holistic Medicine: Applied Consciousness-Based Medicine

    OpenAIRE

    Søren Ventegodt; Joav Merrick

    2004-01-01

    Consciousness-based medicine is our term for a form of medical treatment that works by direct appeal to the consciousness of the patient, in contrast to modern biomedical treatment where drugs are used to affect body chemistry. With this concept, maybe we are (in a sense) turning back to the “old medicine”, where the family physician was the all-concerned “old country doctor” who knew the child, the siblings, the parents, the family, and the village. In a series of papers on clinical holistic...

  10. Regulations and guidelines governing stem cell based products: Clinical considerations

    Directory of Open Access Journals (Sweden)

    Bobby George

    2011-01-01

    Full Text Available The use of stem cells as medicines is a promising and upcoming area of research as they may be able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson′s, multiple sclerosis, heart disease, liver disease, spinal cord damage, cancer and many more. Translating basic stem cell research into routine therapies is a complex multi-step process which entails the challenge related to managing the expected therapeutic benefits with the potential risks while complying with the existing regulations and guidelines. While in the United States (US and European Union (EU regulations are in place, in India, we do not have a well-defined regulatory framework for "stem cell based products (SCBP". There are several areas that need to be addressed as it is quite different from that of pharmaceuticals. These range from establishing batch consistency, product stability to product safety and efficacy through pre-clinical, clinical studies and marketing authorization. This review summarizes the existing regulations/guidelines in US, EU, India, and the associated challenges in developing SCBP with emphasis on clinical aspects.

  11. Activity-based costing for clinical paths. An example to improve clinical cost & efficiency.

    Science.gov (United States)

    Asadi, M J; Baltz, W A

    1996-01-01

    How much does this medical service or surgical procedure cost the hospital to provide? What is the most efficient clinical pathway that maximizes the quality of patient care while minimizing costs? More and more hospitals are discovering that they don't have solid answers to these critically important questions. In an age of managed care and capitation, however, it is imperative for management to know if the patient care services they provide are making or losing money-and by how much. This article discusses how a powerful new tool called activity-based costing (ABC) can be used to help hospitals accurately determine patient care costs. We show how to build a model that combines both clinical and financial data to measure how efficiently the operation allocates human, material and capital resources to provide its services. The modeling approach described in this article can be used to better analyze a wide range of important operational and financial issues, including: How to efficiently allocate resources, and what resources will be needed as patient demand changes-ideal for operational management and planning; How efficiently activities and processes are performed to meet patient needs-effective for measuring performance and improving quality; Determining clinical pathway profitability-essential for understanding where you're making or losing money; Cycle time, throughput and the impact of resource capacity constraints-critical for meeting patient demand; Costs of idle capacity-important for using resources more efficiently. We will illustrate with an example how this modeling technique can be used to develop and implement efficient clinical pathways.

  12. Electronic medical records in humanitarian emergencies – the development of an Ebola clinical information and patient management system [version 3; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Kiran Jobanputra

    2017-02-01

    Full Text Available By November 2015, the West Africa Ebola epidemic had caused 28598 infections and 11299 deaths in the three countries most affected. The outbreak required rapid innovation and adaptation. Médecins sans Frontières (MSF scaled up its usual 20-30 bed Ebola management centres (EMCs to 100-300 beds with over 300 workers in some settings. This brought challenges in patient and clinical data management resulting from the difficulties of working safely with high numbers of Ebola patients. We describe a project MSF established with software developers and the Google Social Impact Team to develop context-adapted tools to address the challenges of recording Ebola clinical information. We share the outcomes and key lessons learned in innovating rapidly under pressure in difficult environmental conditions. Information on adoption, maintenance, and data quality was gathered through review of project documentation, discussions with field staff and key project stakeholders, and analysis of tablet data. In March 2015, a full prototype was deployed in Magburaka EMC, Sierra Leone. Inpatient data were captured on 204 clinical interactions with 34 patients from 5 March until 10 April 2015. Data continued to also be recorded on paper charts, creating theoretically identical record “pairs” on paper and tablet. 83 record pairs for 33 patients with 22 data items (temperature and symptoms per pair were analysed. The overall Kappa coefficient for agreement between sources was 0.62, but reduced to 0.59 when rare bleeding symptoms were excluded, indicating moderate to good agreement. The time taken to deliver the product was more than that anticipated by MSF (7 months versus 6 weeks. Deployment of the tablet coincided with a dramatic drop in patient numbers and thus had little impact on patient care. We have identified lessons specific to humanitarian-technology collaborative projects and propose a framework for emergency humanitarian innovation. Time and effort is

  13. Nucleic acid-based aptamers: applications, development and clinical trials.

    Science.gov (United States)

    Kanwar, Jagat R; Roy, Kislay; Maremanda, Nihal G; Subramanian, Krishnakumar; Veedu, Rakesh N; Bawa, Raj; Kanwar, Rupinder K

    2015-01-01

    Short single-stranded oligonucleotides called aptamers, often termed as chemical antibodies, have been developed as powerful alternatives to traditional antibodies with respect to their obvious advantages like high specificity and affinity, longer shelf-life, easier manufacturing protocol, freedom to introduce chemical modifications for further improvement, etc. Reiterative selection process of aptamers over 10-15 cycles starting from a large initial pool of random nucleotide sequences renders them with high binding affinity, thereby making them extremely specific for their targets. Aptamer-based detection systems are well investigated and likely to displace primitive detection systems. Aptamer chimeras (combination of aptamers with another aptamer or biomacromolecule or chemical moiety) have the potential activity of both the parent molecules, and thus hold the capability to perform diverse functions at the same time. Owing to their extremely high specificity and lack of immunogenicity or pathogenicity, a number of other aptamers have recently entered clinical trials and have garnered favorable attention from pharmaceutical companies. Promising results from the clinical trials provide new hope to change the conventional style of therapy. Aptamers have attained high therapeutic relevance in a short time as compared to synthetic drugs and/or other modes of therapy. This review follows the various trends in aptamer technology including production, selection, modifications and success in clinical fields. It focusses largely on the various applications of aptamers which mainly depend upon their selection procedures. The review also sheds light on various modifications and chimerizations that have been implemented in order to improve the stability and functioning of the aptamers, including introduction of locked nucleic acids (LNAs). The application of various aptamers in detection systems has been discussed elaborately in order to stress on their role as efficient

  14. Zirconia-based fixed partial dentures: a clinical review.

    Science.gov (United States)

    Bachhav, Vinay Chila; Aras, Meena Ajay

    2011-02-01

    Ceramics have a long history in fixed prosthodontics of achieving optimal esthetics. Yttrium tetragonal zirconia polycrystal (Y-TZP)-based systems are a recent addition to the high-strength, all-ceramic systems used for crowns and fixed partial dentures. CAD/CAM-produced, Y-TZP-based systems are in considerable demand in esthetic and stress-bearing regions. The highly esthetic nature of zirconia coupled with its superior physical properties and biocompatibility have resulted in restorative systems that meet the demands of today's patients. Undoubtedly, these systems are considered to be prospective replacements for metal-ceramic restorations. This article reviews relevant contemporary literature regarding all-ceramic materials and systems and discusses their material properties, biocompatibility, advances in cementation, and more with special emphasis on clinical survival. The article also aims to provide recommendations for their use.

  15. Pembrolizumab: first global approval.

    Science.gov (United States)

    Poole, Raewyn M

    2014-10-01

    Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.

  16. Apremilast: first global approval.

    Science.gov (United States)

    Poole, Raewyn M; Ballantyne, Anita D

    2014-05-01

    Apremilast (Otezla(®)), an oral small molecule inhibitor of type-4 cyclic nucleotide phosphodiesterase (PDE-4), is under development with Celgene Corporation for the treatment of psoriatic arthritis, psoriasis, ankylosing spondylitis, Behçet's syndrome, atopic dermatitis, and rheumatoid arthritis. Apremilast is indicated for the treatment of active psoriatic arthritis in adults. Apremilast has received its first global approval for this indication in the USA. Regulatory submissions for approval in this indication are under review in Canada and Europe. Regulatory filings have also been submitted for apremilast in the treatment of plaque psoriasis in the USA and Europe. This article summarizes the milestones in the development of apremilast leading to its first approval for the treatment of psoriatic arthritis.

  17. Evidence-based review of clinical studies on pulpotomy.

    Science.gov (United States)

    2009-08-01

    Although pulpotomy procedures have a long history of clinical application, comparatively few dental clinical trials have evaluated this treatment approach. In this section, we provide an analysis of recent clinical studies evaluating pulpotomy procedures in dental patients.

  18. [Optical Topography as an Auxiliary Laboratory Test for Differential Diagnosis of Depressive State: Clinical Application of Near-infrared Spectroscopy (NIRS) as the First Trial for Approved Laboratory Tests in Psychiatry].

    Science.gov (United States)

    Fukuda, Masato

    2015-01-01

    The lack of clinical laboratory tests is a major obstacle in the reliable diagnosis and quantitative treatment assessment and prevention of psychiatric disorders and in the development of patient-centric psychiatric practices. Optical topography has been approved as an insurance-covered auxiliary laboratory test for differential diagnosis of depressive state by Ministry of Health, Labour and Welfare in Japan since 2014. Near-infrared spectroscopy (NIRS), theoretical basis of optical topography, is one of functional neuroimaging techniques that has been increasingly employed in psychology and psychiatry. Because NIRS can detect only cerebral cortex reactivities with low spatial resolution and may suffer from contaminating signals from skin and skull, its data should be interpreted as a global index of cerebral cortex reactivities. Within these limitations, the advantages of NIRS over fMRI such as complete non-invasiveness, small measurement apparatus, high time resolution, and natural examination setting lead it to one of the preferred methods in studies of brain substrates of psychiatric disorders. Two-thirds of the original articles on NIRS application in psychiatry have been published by Japanese researchers. NIRS examination of major depressive disorder, bipolar disorder, and schizophrenia using a verbal fluency task of only three minutes demonstrated diagnosis-specific characteristics of frontal lobe function. These characteristics have been established as suggesting potential diagnosis of bipolar disorder or schizophrenia in clinically diagnosed major depressive disorder. In order to establish the application of NIRS as clinically useful laboratory tests in psychiatry, auxiliary nature of NIRS examination for differential diagnosis should be properly recognized both by patients and psychiatrists.

  19. 78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

    Science.gov (United States)

    2013-02-25

    ... documenting the review and approval of the study by an independent ethics committee (IEC) and obtaining and... for acceptance of a PMA application for marketing approval based solely on foreign clinical data, and... this document) identifying ethical and other principles that provide assurance of the quality...

  20. Medical Device Approvals Through the Premarket Approval Pathway in Obstetrics and Gynecology From 2000 to 2015: Process and Problems.

    Science.gov (United States)

    Walter, Jessica R; Hayman, Emily; Tsai, Shelun; Ghobadi, Comeron W; Xu, Shuai

    2016-06-01

    Recent controversies surrounding obstetrics and gynecology devices, including a permanent sterilization device, pelvic meshes, and laparoscopic morcellators, highlight the need for deeper understanding of obstetrics and gynecology medical device regulation. The U.S. Food and Drug Administration premarket approval database was queried for approvals assigned to the obstetrics and gynecology advisory committee from January 2000 to December 2015. Eighteen device approvals occurred in the time period studied. The most common clinical indications included endometrial ablation (33%), contraception (28%), and fetal monitoring (17%). The median approval time was 290 days (range 178-1,399 days). Regarding the pivotal trials leading to approval, there were 11 randomized controlled trials, one randomized crossover study, five nonrandomized prospective studies, and two human factor studies. Fourteen devices (78%) met their primary clinical efficacy endpoint. Only 12 of 18 devices were required to conduct postmarket surveillance. A significant proportion of devices (42%) were approved on the basis of nonrandomized controlled trials. Three devices have been withdrawn after approval, all of which were either not referred or not recommended for approval by the obstetrics and gynecology advisory committee. Of the three devices withdrawn from the market, two failed to demonstrate clinical benefit in their pivotal trials. One device was not required to undergo postmarketing surveillance and was subsequently withdrawn as a result of patient safety concerns. Our results reveal significant weaknesses in the preapproval and postapproval regulation of high-risk obstetrics and gynecology devices. Greater specialty group involvement is necessary to ensure the development of safe and clinically effective devices.

  1. Clinical trial designs for testing biomarker-based personalized therapies

    Science.gov (United States)

    Lai, Tze Leung; Lavori, Philip W; Shih, Mei-Chiung I; Sikic, Branimir I

    2014-01-01

    Background Advances in molecular therapeutics in the past decade have opened up new possibilities for treating cancer patients with personalized therapies, using biomarkers to determine which treatments are most likely to benefit them, but there are difficulties and unresolved issues in the development and validation of biomarker-based personalized therapies. We develop a new clinical trial design to address some of these issues. The goal is to capture the strengths of the frequentist and Bayesian approaches to address this problem in the recent literature and to circumvent their limitations. Methods We use generalized likelihood ratio tests of the intersection null and enriched strategy null hypotheses to derive a novel clinical trial design for the problem of advancing promising biomarker-guided strategies toward eventual validation. We also investigate the usefulness of adaptive randomization (AR) and futility stopping proposed in the recent literature. Results Simulation studies demonstrate the advantages of testing both the narrowly focused enriched strategy null hypothesis related to validating a proposed strategy and the intersection null hypothesis that can accommodate to a potentially successful strategy. AR and early termination of ineffective treatments offer increased probability of receiving the preferred treatment and better response rates for patients in the trial, at the expense of more complicated inference under small-to-moderate total sample sizes and some reduction in power. Limitations The binary response used in the development phase may not be a reliable indicator of treatment benefit on long-term clinical outcomes. In the proposed design, the biomarker-guided strategy (BGS) is not compared to ‘standard of care’, such as physician’s choice that may be informed by patient characteristics. Therefore, a positive result does not imply superiority of the BGS to ‘standard of care’. The proposed design and tests are valid asymptotically

  2. Effect of currently approved carriers and adjuvants on the pre-clinical efficacy of a conjugate vaccine against oxycodone in mice and rats.

    Directory of Open Access Journals (Sweden)

    Marco Pravetoni

    Full Text Available Vaccination against the highly abused prescription opioid oxycodone has shown pre-clinical efficacy for blocking oxycodone effects. The current study further evaluated a candidate vaccine composed of oxycodone derivatized at the C6 position (6OXY conjugated to the native keyhole limpet hemocyanin (nKLH carrier protein. To provide an oxycodone vaccine formulation suitable for human studies, we studied the effect of alternative carriers and adjuvants on the generation of oxycodone-specific serum antibody and B cell responses, and the effect of immunization on oxycodone distribution and oxycodone-induced antinociception in mice and rats. 6OXY conjugated to tetanus toxoid (TT or a GMP grade KLH dimer (dKLH was as effective as 6OXY conjugated to the nKLH decamer in mice and rats, while the 6OXY hapten conjugated to a TT-derived peptide was not effective in preventing oxycodone-induced antinociception in mice. Immunization with 6OXY-TT s.c. absorbed on alum adjuvant provided similar protection to 6OXY-TT administered i.p. with Freund's adjuvant in rats. The toll-like receptor 4 (TLR4 agonist monophosphoryl lipid A (MPLA adjuvant, alone or in combination with alum, offered no advantage over alum alone for generating oxycodone-specific serum antibodies or 6OXY-specific antibody secreting B cells in mice vaccinated with 6OXY-nKLH or 6OXY-TT. The immunogenicity of oxycodone vaccines may be modulated by TLR4 signaling since responses to 6OXY-nKLH in alum were decreased in TLR4-deficient mice. These data suggest that TT, nKLH and dKLH carriers provide consistent 6OXY conjugate vaccine immunogenicity across species, strains and via different routes of administration, while adjuvant formulations may need to be tailored to individual immunogens or patient populations.

  3. Parasite-based screening and proteome profiling reveal orlistat, an FDA-approved drug, as a potential anti Trypanosoma brucei agent.

    Science.gov (United States)

    Yang, Peng-Yu; Wang, Min; Liu, Kai; Ngai, Mun Hong; Sheriff, Omar; Lear, Martin J; Sze, Siu Kwan; He, Cynthia Y; Yao, Shao Q

    2012-07-02

    Trypanosoma brucei is a parasite that causes African sleeping sickness in humans and nagana in livestock and is transmitted by the tsetse fly. There is an urgent need for the development of new drugs against African trypanosomiasis due to the lack of vaccines and effective drugs. Orlistat (also called tetrahydrolipstatin or THL) is an FDA-approved antiobesity drug targeting primarily the pancreatic and gastric lipases within the gastrointestinal tract. It shows potential activities against tumors, mycobacteria, and parasites. Herein, we report the synthesis and evaluation of an expanded set of orlistat-like compounds, some of which showed highly potent trypanocidal activities in both the bloodstream form (BSF) and the procyclic form (PCF) of T. brucei. Subsequent in situ parasite-based proteome profiling was carried out to elucidate potential cellular targets of the drug in both forms. Some newly identified targets were further validated by the labeling of recombinantly expressed enzymes in Escherichia coli lysates. Bioimaging experiments with a selected compound were carried out to study the cellular uptake of the drug in T. brucei. Results indicated that orlistat is much more efficiently taken up by the BSF than the PCF of T. brucei and has clear effects on the morphology of mitochondria, glycosomes, and the endoplasmic reticulum in both BSF and PCF cells. These results support specific effects of orlistat on these organelles and correlate well with our in situ proteome profiling. Given the economic challenges of de novo drug development for neglected diseases, we hope that our findings will stimulate further research towards the conversion of orlistat-like compounds into new trypanocidal drugs.

  4. Model Comparison for Breast Cancer Prognosis Based on Clinical Data.

    Directory of Open Access Journals (Sweden)

    Sabri Boughorbel

    Full Text Available We compared the performance of several prediction techniques for breast cancer prognosis, based on AU-ROC performance (Area Under ROC for different prognosis periods. The analyzed dataset contained 1,981 patients and from an initial 25 variables, the 11 most common clinical predictors were retained. We compared eight models from a wide spectrum of predictive models, namely; Generalized Linear Model (GLM, GLM-Net, Partial Least Square (PLS, Support Vector Machines (SVM, Random Forests (RF, Neural Networks, k-Nearest Neighbors (k-NN and Boosted Trees. In order to compare these models, paired t-test was applied on the model performance differences obtained from data resampling. Random Forests, Boosted Trees, Partial Least Square and GLMNet have superior overall performance, however they are only slightly higher than the other models. The comparative analysis also allowed us to define a relative variable importance as the average of variable importance from the different models. Two sets of variables are identified from this analysis. The first includes number of positive lymph nodes, tumor size, cancer grade and estrogen receptor, all has an important influence on model predictability. The second set incudes variables related to histological parameters and treatment types. The short term vs long term contribution of the clinical variables are also analyzed from the comparative models. From the various cancer treatment plans, the combination of Chemo/Radio therapy leads to the largest impact on cancer prognosis.

  5. Nanomaterial-Based Electrochemical Immunosensors for Clinically Significant Biomarkers

    Directory of Open Access Journals (Sweden)

    Niina J. Ronkainen

    2014-06-01

    Full Text Available Nanotechnology has played a crucial role in the development of biosensors over the past decade. The development, testing, optimization, and validation of new biosensors has become a highly interdisciplinary effort involving experts in chemistry, biology, physics, engineering, and medicine. The sensitivity, the specificity and the reproducibility of biosensors have improved tremendously as a result of incorporating nanomaterials in their design. In general, nanomaterials-based electrochemical immunosensors amplify the sensitivity by facilitating greater loading of the larger sensing surface with biorecognition molecules as well as improving the electrochemical properties of the transducer. The most common types of nanomaterials and their properties will be described. In addition, the utilization of nanomaterials in immunosensors for biomarker detection will be discussed since these biosensors have enormous potential for a myriad of clinical uses. Electrochemical immunosensors provide a specific and simple analytical alternative as evidenced by their brief analysis times, inexpensive instrumentation, lower assay cost as well as good portability and amenability to miniaturization. The role nanomaterials play in biosensors, their ability to improve detection capabilities in low concentration analytes yielding clinically useful data and their impact on other biosensor performance properties will be discussed. Finally, the most common types of electroanalytical detection methods will be briefly touched upon.

  6. Additional safety risk to exceptionally approved drugs in Europe?

    Science.gov (United States)

    Arnardottir, Arna H; Haaijer-Ruskamp, Flora M; Straus, Sabine M J; Eichler, Hans-Georg; de Graeff, Pieter A; Mol, Peter G M

    2011-09-01

    Regulatory requirements for new drugs have increased. Special approval procedures with priority assessment are possible for drugs with clear 'unmet medical need'. We question whether these Exceptional Circumstances (EC) or Conditional Approval (CA) procedures have led to a higher probability of serious safety issues. A retrospective cohort study was performed of new drugs approved in Europe between 1999 and 2009. The determinant was EC/CA vs. standard procedure approval. Outcome variables were frequency and timing of a first Direct Healthcare Professional Communication (DHPC). An association between approval procedure and the time from market approval to DHPC was assessed using Kaplan-Meyer survival analysis and Cox-regression to correct for covariates. In total 289 new drugs were approved. Forty-six (16.4%) were approved under EC or CA, of which seven received a DHPC (15%). This was similar to the standard approval drugs (243), of which 33 received one or more DHPC (14%, P= 0.77). The probability of acquiring a DHPC for standard approval drugs vs. EC/CA drugs during 11-year follow-up is 22% (95% CI 14%, 29%) and 26% (95% CI 8%, 44%), respectively (log-rank P= 0.726). This difference remained not significant in the Cox-regression model: hazard ratio 0.94 (95% CI 0.40, 2.20). Only drug type was identified as a confounding covariate. The EC/CA procedure is not associated with a higher probability of DHPCs despite limited clinical development data. These data do not support the view that early drug approval increases the risk of serious safety issues emerging after market approval. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

  7. Heartland Winthrop Approval

    Science.gov (United States)

    This May 19, 2016 letter from EPA approves the petition from Heartland Corn Products regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS program.

  8. Poet Lake Crystal Approval

    Science.gov (United States)

    This September 19, 2016 letter from EPA approves the petition from Poet Biorefining-Lake Crystal, regarding non-grandfathered ethanol produced through a dry mill process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the RFS

  9. FDA Approval for Imiquimod

    Science.gov (United States)

    On July 15, 2004, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Aldara® (imiquimod) topical cream for the treatment of superficial basal cell carcinoma (sBCC), a type of skin cancer.

  10. FHR Iowa Falls Approval

    Science.gov (United States)

    This October 22, 2015, letter from EPA approves the petition from Flint Hills Resources, LLC, regarding non-grandfathered ethanol produced through the FHR Iowa Falls Process, qualifying under the Clean Air Act for renewable fuel (D-code 6) RINs under the R

  11. Clinical Application of Image-Based CFD for Cerebral Aneurysms.

    Science.gov (United States)

    Cebral, Jr; Mut, F; Sforza, D; Löhner, R; Scrivano, E; Lylyk, P; Putman, Cm

    2011-07-01

    During the last decade, the convergence of medical imaging and computational modeling technologies has enabled tremendous progress in the development and application of image-based computational fluid dynamics modeling of patient-specific blood flows. These techniques have been used for studying the basic mechanisms involved in the initiation and progression of vascular diseases, for studying possible ways to improve the diagnosis and evaluation of patients by incorporating hemodynamics information to the anatomical data typically available, and for the development of computational tools that can be used to improve surgical and endovascular treatment planning. However, before these technologies can have a significant impact on the routine clinical practice, it is still necessary to demonstrate the connection between the extra information provided by the models and the natural progression of vascular diseases and the outcome of interventions. This paper summarizes some of our contributions in this direction, focusing in particular on cerebral aneurysms.

  12. 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.

  13. Evidence-based medicine and values-based medicine: partners in clinical education as well as in clinical practice.

    Science.gov (United States)

    Peile, Ed

    2013-02-15

    The best clinical decisions are based on both evidence and values in what is known as the 'two-feet principle'. Anecdotally, educationalists find teaching clinicians to become more evidence based is relatively simple in comparison to encouraging them to become more values based. One reason is likely to be the importance of values awareness. As values-based practice is premised on a mutual respect for the diversity of values, clinicians need to develop the skills to ascertain patient values and to get in touch with their own beliefs and preferences in order to understand those at play in any consultation. Only then can shared decision-making processes take place within a shared framework of values. In a research article published in BMC Medicine, Altamirano-Bustamante and colleagues highlight difficulties that clinicians face in getting in touch with their own values. Despite finding that healthcare personnel's core values were honesty and respect, autonomy was initially low ranked by participants. One significant aspect of this work is that this group has demonstrated that the extent to which clinicians value 'autonomy' and 'openness to change' can both be positively influenced by well designed education.

  14. Ethics of orthodontic clinical research based on Helsinki declaration

    Directory of Open Access Journals (Sweden)

    Eka Erwansyah

    2016-06-01

    Full Text Available Declaration of Helsinki code of ethics on human experimentation, states that the desin and peformance of experimental procedures involving human should be clearly formulated in an experimental protocol, Todeterminewhetheraninvestigationin accordancewiththe code of conductin a researchthen letusconsider the contentofthe declarationhelsinkiasour referencein conductingaclinicalstudyusinghuman subjects. In journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian.

  15. Preparing dental students for careers as independent dental professionals: clinical audit and community-based clinical teaching.

    Science.gov (United States)

    Lynch, C D; Llewelyn, J; Ash, P J; Chadwick, B L

    2011-05-28

    Community-based clinical teaching programmes are now an established feature of most UK dental school training programmes. Appropriately implemented, they enhance the educational achievements and competences achieved by dental students within the earlier part of their developing careers, while helping students to traverse the often-difficult transition between dental school and vocational/foundation training and independent practice. Dental school programmes have often been criticised for 'lagging behind' developments in general dental practice - an important example being the so-called 'business of dentistry', including clinical audit. As readers will be aware, clinical audit is an essential component of UK dental practice, with the aims of improving the quality of clinical care and optimising patient safety. The aim of this paper is to highlight how training in clinical audit has been successfully embedded in the community-based clinical teaching programme at Cardiff.

  16. Influence of the training: " Clinical practice based on the evidence " in the daily practice of the nurse

    Directory of Open Access Journals (Sweden)

    Ligia Rojas Valenciano

    2013-10-01

    Full Text Available The aim of this article is to present the results of the project Not. 421-B1-261: Influence of the training of theClinical Practice Based on the Evidence on the daily practice of the professional of nursing, approved by the Vicerrectoríaof Investigation of the University of Costa Rica. The commitment to renew the practice of Nursing in Costa Rica relates in adirect way to the improvement of the health of the society both in the collective thing and in the individual thing, in order toreduce the mistakes in the practice. A search was realized in EBSCO's databases, PubMed, Academic Research Completes,MedLine Plus and Scielo. A preliminary search was carried out, then limits of search interfered per date and describers;finally, for the critical analysis they were included only to complete text by title and they summarize 30 documents thatincluded reviews of literature, primary studies and conceptual frames that were relevant to give response to the clinicalquestion. Of 30 documents only it was considered six of them by your content, methodological structure and quality.Though there was not situated a forceful and direct response to the clinical question raised in this study, for the effectedreview it is possible to conclude that the professionals of Nursing consider to be essential the enrichment of a clinicalpractice based on the evidence, which generates a major quality and safety in the executed care.

  17. Integration of imaging into clinical practice to assess the delivery and performance of macromolecular and nanotechnology-based oncology therapies.

    Science.gov (United States)

    Spence, Tara; De Souza, Raquel; Dou, Yannan; Stapleton, Shawn; Reilly, Raymond M; Allen, Christine

    2015-12-10

    Functional and molecular imaging has become increasingly used to evaluate interpatient and intrapatient tumor heterogeneity. Imaging allows for assessment of microenvironment parameters including tumor hypoxia, perfusion and proliferation, as well as tumor metabolism and the intratumoral distribution of specific molecular markers. Imaging information may be used to stratify patients for targeted therapies, and to define patient populations that may benefit from alternative therapeutic approaches. It also provides a method for non-invasive monitoring of treatment response at earlier time-points than traditional cues, such as tumor shrinkage. Further, companion diagnostic imaging techniques are becoming progressively more important for development and clinical implementation of targeted therapies. Imaging-based companion diagnostics are likely to be essential for the validation and FDA approval of targeted nanotherapies and macromolecular medicines. This review describes recent clinical advances in the use of functional and molecular imaging to evaluate the tumor microenvironment. Additionally, this article focuses on image-based assessment of distribution and anti-tumor effect of nano- and macromolecular systems.

  18. Clinical Holistic Medicine: Applied Consciousness-Based Medicine

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2004-01-01

    Full Text Available Consciousness-based medicine is our term for a form of medical treatment that works by direct appeal to the consciousness of the patient, in contrast to modern biomedical treatment where drugs are used to affect body chemistry. With this concept, maybe we are (in a sense turning back to the “old medicine”, where the family physician was the all-concerned “old country doctor” who knew the child, the siblings, the parents, the family, and the village. In a series of papers on clinical holistic medicine, we would like to present the classic art of healing, where the physician works mostly with his hands, then show how the modern biomedical physician performs with biochemistry, and finally introduce consciousness-based medicine. Some of our questions will be: If you improve your quality of life, will you also improve your health? Will learning more about yourself bring more purpose in your life? Will finding someone to live with in a loving and mutually respectful relationship improve your health? Scientists and thinkers like Antonovsky, Frankl, Maslow, and Jung have pointed to love as a unique way to coherence in life, and thus to biological order and a better health. Several scientific studies have also suggested that patients who focus on improving their quality of life usually will not follow the general statistics for survival, since somehow other factors are at play, which sometimes you will find referred to as “exceptional”.

  19. Clinical holistic medicine: applied consciousness-based medicine.

    Science.gov (United States)

    Ventegodt, Søren; Merrick, Joav

    2004-03-03

    Consciousness-based medicine is our term for a form of medical treatment that works by direct appeal to the consciousness of the patient, in contrast to modern biomedical treatment where drugs are used to affect body chemistry. With this concept, maybe we are (in a sense) turning back to the "old medicine", where the family physician was the all-concerned "old country doctor" who knew the child, the siblings, the parents, the family, and the village. In a series of papers on clinical holistic medicine, we would like to present the classic art of healing, where the physician works mostly with his hands, then show how the modern biomedical physician performs with biochemistry, and finally introduce consciousness-based medicine. Some of our questions will be: If you improve your quality of life, will you also improve your health? Will learning more about yourself bring more purpose in your life? Will finding someone to live with in a loving and mutually respectful relationship improve your health? Scientists and thinkers like Antonovsky, Frankl, Maslow, and Jung have pointed to love as a unique way to coherence in life, and thus to biological order and a better health. Several scientific studies have also suggested that patients who focus on improving their quality of life usually will not follow the general statistics for survival, since somehow other factors are at play, which sometimes you will find referred to as "exceptional".

  20. FDA Approvals - Cancer Currents Blog

    Science.gov (United States)

    A catalog of posts from NCI’s Cancer Currents blog on new Food and Drug Administration approvals of cancer drugs. All posts include summaries of the evidence to support the new approvals and what they mean for patients.

  1. Drugs Approved for Skin Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Skin Cancer This page lists cancer drugs approved by the Food and Drug Administration (FDA) for skin cancer, including drugs for basal cell carcinoma, melanoma, and ...

  2. Workplace-based clinical leadership training increases willingness to lead.

    Science.gov (United States)

    MacPhail, Aleece; Young, Carmel; Ibrahim, Joseph Elias

    2015-01-01

    The purpose of this paper is to reflect upon a workplace-based, interdisciplinary clinical leadership training programme (CLP) to increase willingness to take on leadership roles in a large regional health-care centre in Victoria, Australia. Strengthening the leadership capacity of clinical staff is an advocated strategy for improving patient safety and quality of care. An interdisciplinary approach to leadership is increasingly emphasised in the literature; however, externally sourced training programmes are expensive and tend to target a single discipline. Appraisal of the first two years of CLP using multiple sourced feedback. A structured survey questionnaire with closed-ended questions graded using a five-point Likert scale was completed by participants of the 2012 programme. Participants from the 2011 programme were followed up for 18 months after completion of the programme to identify the uptake of new leadership roles. A reflective session was also completed by a senior executive staff that supported the implementation of the programme. Workplace-based CLP is a low-cost and multidisciplinary alternative to externally sourced leadership courses. The CLP significantly increased willingness to take on leadership roles. Most participants (93 per cent) reported that they were more willing to take on a leadership role within their team. Fewer were willing to lead at the level of department (79 per cent) or organisation (64 per cent). Five of the 11 participants from the 2011 programme had taken on a new leadership role 18 months later. Senior executive feedback was positive especially around the engagement and building of staff confidence. They considered that the CLP had sufficient merit to support continuation for at least another two years. Integrating health-care professionals into formal and informal leadership roles is essential to implement organisational change as part of the drive to improve the safety and quality of care for patients and service users

  3. Danish clinical databases: An overview

    DEFF Research Database (Denmark)

    Green, Anders

    2011-01-01

    Clinical databases contain data related to diagnostic procedures, treatments and outcomes. In 2001, a scheme was introduced for the approval, supervision and support to clinical databases in Denmark....

  4. Pitolisant: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2016-09-01

    Pitolisant (Wakix™) is an inverse agonist of the histamine H3 receptor that is being developed by Bioproject. Oral pitolisant is approved in the EU for the treatment of narcolepsy with or without cataplexy in adults. Pitolisant has received a Temporary Authorization of Use in France for this indication in case of treatment failure, intolerance or contraindication to currently available treatment. Pitolisant has orphan drug designation in the EU and the USA. In the pivotal HARMONY I trial, pitolisant significantly decreased excessive daytime sleepiness versus placebo in adults with narcolepsy with or without cataplexy (primary endpoint). Pitolisant also significantly decreased cataplexy rate versus placebo in these patients. This article summarizes the milestones in the development of pitolisant leading to this first approval for narcolepsy.

  5. Rucaparib: First Global Approval.

    Science.gov (United States)

    Syed, Yahiya Y

    2017-04-01

    Rucaparib (Rubraca™) is an oral, small molecule, poly (ADP-ribose) polymerase inhibitor being developed by Clovis Oncology, Inc. (Boulder, CO, USA) for the treatment of solid tumours. It has been approved in the USA as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. A marketing authorization application for rucaparib for the same indication has been submitted to the European Medicines Agency. Rucaparib is also under phase II or III investigation in ovarian, breast and prostate cancer. This article summarizes the milestones in the development of rucaparib leading to this first approval for ovarian cancer.

  6. Baricitinib: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2017-03-13

    Baricitinib (Olumiant™) is an orally-administered, small-molecule, janus-associated kinase (JAK) inhibitor developed by Eli Lilly and Incyte Corporation for the treatment of rheumatoid arthritis (RA), atopic dermatitis and systemic lupus erythematosus. JAKs transduce intracellular signals from cell surface receptors for various cytokines and growth factors involved in inflammation and immune function, suggesting JAK inhibitors may be of therapeutic benefit in inflammatory conditions. In February 2017, baricitinib was approved in the EU, as monotherapy or in combination with methotrexate, for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Regulatory approval to market baricitinib as a treatment for RA has also been sought in the USA and Japan. This article summarizes the milestones in the development of baricitinib leading to this first global approval for the treatment for moderate to severe active RA in adult patients who have responded inadequately to, or are intolerant to one or more DMARDs.

  7. Evolocumab: First Global Approval.

    Science.gov (United States)

    Markham, Anthony

    2015-09-01

    Evolocumab (Repatha™) is a fully human monoclonal antibody developed by Amgen that has been approved as a treatment for hypercholesterolaemia in the EU, and is awaiting approval in the USA and Japan. It specifically binds proprotein convertase subtilisin/kexin type 9 (PCSK9)-a negative regulator of low-density lipoprotein (LDL)-receptors-thereby improving the ability of the liver to bind LDL-cholesterol (LDL-C), leading to reduced LDL-C blood levels. The drug reduces LDL-C levels in patients with hypercholesterolaemia when used as monotherapy or in conjunction with a statin. This article summarizes the milestones in the development of evolocumab leading to this approval for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet with or without a statin and/or other lipid lowering therapies, and in adults and adolescents aged ≥12 years with homozygous familial hypercholesterolaemia in combination with other lipid lowering therapies.

  8. [Evidence-based clinical guidelines in dental practice 6. Guidelines for clinical practice in dental education].

    Science.gov (United States)

    van der Sanden, W J M; Gorter, R; Tams, J

    2015-09-01

    In response to the initiatives of the Kennisinstituut Mondzorg (Institute for Knowledge Translation in Oral Care), the importance of effective education in the area of guidelines is increasing. Future dentists will, after all, be confronted with new guidelines and need to be able to integrate them in their daily practice. Various guidelines and protocols have been established within the 3 dental schools. For students and instructors, however, the motivation for these guidelines and protocols is not always sufficiently clear. In addition, the terms guideline, clinical practice guideline and protocol are used interchangeably, resulting in terminological confusion. Embedding within and coordination with theoretical education is also still limited in all programmes and it is proposed that the 3 dental schools collaborate on this issue. Finally, it is advised to replace the term 'evidence-based' with 'evidence-informed' because this indicates more clearly that other factors (patients opinion, available financial means, etc.) play a role in the final choice of treatment in a specific situation.

  9. Clinical-outcome-based demand management in health services.

    Science.gov (United States)

    Brogan, C; Lawrence, D; Mayhew, L

    2008-01-01

    THE PROBLEM OF MANAGING DEMAND: Most healthcare systems have 'third-party payers' who face the problem of keeping within budgets despite pressures to increase resources due to the ageing population, new technologies and patient demands to lower thresholds for care. This paper uses the UK National Health Service as a case study to suggest techniques for system-based demand management, which aims to control demand and costs whilst maintaining the cost-effectiveness of the system. The technique for managing demand in primary, elective and urgent care consists of managing treatment thresholds for appropriate care, using a whole-systems approach and costing the care elements in the system. It is important to analyse activity in relation to capacity and demand. Examples of using these techniques in practice are given. The practical effects of using such techniques need evaluation. If these techniques are not used, managing demand and limiting healthcare expenditure will be at the expense of clinical outcomes and unmet need, which will perpetuate financial crises.

  10. 21 CFR 814.118 - Denial of approval or withdrawal of approval of an HDE.

    Science.gov (United States)

    2010-04-01

    ... HUMAN SERVICES (CONTINUED) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES Humanitarian Use...; (7) Any clinical investigation involving human subjects described in the HDE, subject to the institutional review board regulations in part 56 of this chapter or the informed consent regulations in part...

  11. The dilemma of approving antidotes.

    Science.gov (United States)

    Steffen, Christian

    2007-04-20

    Clinical trials with antidotes are difficult to perform for a variety of practical, ethical, and financial reasons. As acute poisoning is a rare event, the commercial interest in basic and clinical research is low. Poisoned patients are usually not available for normal clinical trial procedures and, if they are, they cannot give informed consent. This situation results in a dilemma: antidotes are essential drugs. A resolution of the Council of Europe requests to guarantee the optimal availability of antidotes and the improvement of their use. As comprehensive data on the efficacy of antidotes are often missing, a marketing authorisation under exceptional circumstances according to Article 14(8) of Regulation (EC) No. 276/2004, will often be the only way to get an approval, as: (1) the indications for which the product in question is intended are encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence ("orphan drug"), (2) in the present state of scientific knowledge, comprehensive information cannot be provided, or (3) it would be contrary to generally accepted principles of medical ethics to collect such data. Typically, data on antidotes are obtained from a patchwork of studies with animals, human tissue and a few observations from human poisoning corroborated with data from clinical observations and biochemistry. Generalisations from chemical and mechanistic similarities between groups of poisons are usual, but often lack scientific evidence. Current standards of good clinical practice can rarely be observed. Therefore, public funding and other financial support are necessary incentives to initiate trials in this important area.

  12. 深化行政审批制度改革推进法治政府建设——以海南省行政审批制度改革为视角%Further Reform of Administrative Approval Regime to Promote. Build - Up of a Government Based on Rule of Law -From the Perspective of Reform of Administrative Approval Regime in Hainan Province

    Institute of Scientific and Technical Information of China (English)

    李林

    2012-01-01

    深化行政审批制度改革,是新世纪以来我国推进行政体制改革,建设法治政府建设的重要内容。本文以海南省行政审批制度改革的理论与实践创新为视角,分析论述了该省政务服务中心相对集中行政审批权,全面推进行政审批体制机制改革;努力加强行政审批的阳光政务建设,强化权力监督制约,确保廉洁高效审批;努力加强电子政务建设,实行网上行政审批,全面提升行政审批的效率和群众满意度,初步形成了地方行政审批制度改革的“海南模式”。%Further reform of administrative approval regime is an important component of further reform of the administrative regime in China so as to build up a government based on rule of law. From the perspective of the innovative theory and practices of the reform of administrative approval regime in Hainan Province, this thesis gives a thorough analysis thereon. The administrative service centre of Hainan Province has relatively gathered the approval powers of various departments under the provincial government. The comprehensive structural reform of the administrative approval regime has moved forward. With the enthusiastically build - up of an open government with regard to administrative approvals, administrative powers in Hainan are under the check of an enhanced strict supervision so as to ensure an effective and clean operation of the administrative approval regime. Administrative approvals are aw~ded online in Hainan under a framework of strengthened e - government scheme so as to comprehensively improve the efficiency and reliability of the administrative approval regime. A "Hainan Model" is thus beginning to emerge for the reform of local administrative approval regimes to follow.

  13. Teaching clinical reasoning: case-based and coached.

    Science.gov (United States)

    Kassirer, Jerome P

    2010-07-01

    Optimal medical care is critically dependent on clinicians' skills to make the right diagnosis and to recommend the most appropriate therapy, and acquiring such reasoning skills is a key requirement at every level of medical education. Teaching clinical reasoning is grounded in several fundamental principles of educational theory. Adult learning theory posits that learning is best accomplished by repeated, deliberate exposure to real cases, that case examples should be selected for their reflection of multiple aspects of clinical reasoning, and that the participation of a coach augments the value of an educational experience. The theory proposes that memory of clinical medicine and clinical reasoning strategies is enhanced when errors in information, judgment, and reasoning are immediately pointed out and discussed. Rather than using cases artificially constructed from memory, real cases are greatly preferred because they often reflect the false leads, the polymorphisms of actual clinical material, and the misleading test results encountered in everyday practice. These concepts foster the teaching and learning of the diagnostic process, the complex trade-offs between the benefits and risks of diagnostic tests and treatments, and cognitive errors in clinical reasoning. The teaching of clinical reasoning need not and should not be delayed until students gain a full understanding of anatomy and pathophysiology. Concepts such as hypothesis generation, pattern recognition, context formulation, diagnostic test interpretation, differential diagnosis, and diagnostic verification provide both the language and the methods of clinical problem solving. Expertise is attainable even though the precise mechanisms of achieving it are not known.

  14. A review of blood substitutes: examining the history, clinical trial results, and ethics of hemoglobin-based oxygen carriers

    Directory of Open Access Journals (Sweden)

    Jiin-Yu Chen

    2009-01-01

    Full Text Available The complications associated with acquiring and storing whole blood for transfusions have launched substantial efforts to develop a blood substitute. The history of these efforts involves a complicated mixture of science, ethics, and business. This review focuses on clinical trials of the three hemoglobin-based oxygen carriers (HBOC that have progressed to Phase II or III clinical trials: HemAssist (Baxter; Deerfield, IL, US, PolyHeme (Northfield; Evanston, IL, US, and Hemopure (Biopure; Cambridge, MA, US. Published animal studies and clinical trials carried out in a perioperative setting have demonstrated that these products successfully transport and deliver oxygen, but all may induce hypertension and lead to unexpectedly low cardiac outputs. Overall, these studies suggest that HBOCs resulted in only modest blood saving during and after surgery, no improvement in mortality and an increased incidence of adverse reactions. To date, the results from these perioperative studies have not led to regulatory approval. All three companies instead chose to focus their efforts on large trials of trauma patients in the pre-hospital setting. Baxter abandoned the development of HemAssist after a trial in the U.S. was prematurely halted when the first 100 patients showed significantly increased mortality rates as compared to patients treated with blood products. Northfield's PolyHeme trial demonstrated a non-significant trend towards increased mortality and a very modest reduction in the subsequent need for blood. The testing of Biopure's Hemopure for trauma patients has been halted for several years because of FDA concerns over trial design and study justification. Ethical concerns have also been raised regarding the design and implementation of all HBOC clinical trials. Thus, the available evidence suggests that HemAssist, Polyheme, and Hemopure are associated with a significant level of cardiovascular dysfunction. The next generation of HBOCs remains

  15. 30 CFR 18.11 - Approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 18.11 Section 18.11 Mineral... plate. (a)(1) The notice of approval will be accompanied by a photograph of an approval plate, bearing... number shall be added to the original approval number on the approval plate. (Example: Original approval...

  16. Metagenomic analysis of medicinal Cannabis samples; pathogenic bacteria, toxigenic fungi, and beneficial microbes grow in culture-based yeast and mold tests [version 1; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Kevin McKernan

    2016-10-01

    Full Text Available Background: The presence of bacteria and fungi in medicinal or recreational Cannabis poses a potential threat to consumers if those microbes include pathogenic or toxigenic species. This study evaluated two widely used culture-based platforms for total yeast and mold (TYM testing marketed by 3M Corporation and Biomérieux, in comparison with a quantitative PCR (qPCR approach marketed by Medicinal Genomics Corporation. Methods: A set of 15 medicinal Cannabis samples were analyzed using 3M and Biomérieux culture-based platforms and by qPCR to quantify microbial DNA. All samples were then subjected to next-generation sequencing and metagenomics analysis to enumerate the bacteria and fungi present before and after growth on culture-based media. Results: Several pathogenic or toxigenic bacterial and fungal species were identified in proportions of >5% of classified reads on the samples, including Acinetobacter baumannii, Escherichia coli, Pseudomonas aeruginosa, Ralstonia pickettii, Salmonella enterica, Stenotrophomonas maltophilia, Aspergillus ostianus, Aspergillus sydowii, Penicillium citrinum and Penicillium steckii. Samples subjected to culture showed substantial shifts in the number and diversity of species present, including the failure of Aspergillus species to grow well on either platform. Substantial growth of Clostridium botulinum and other bacteria were frequently observed on one or both of the culture-based TYM platforms. The presence of plant growth promoting (beneficial fungal species further influenced the differential growth of species in the microbiome of each sample. Conclusions: These findings have important implications for the Cannabis and food safety testing industries.

  17. Significance of Evidence-based Medicine in the Assessment of Chinese Medicine Clinical Efficacy

    Institute of Scientific and Technical Information of China (English)

    WANG Ji-yao

    2010-01-01

    @@ Evidence-based medicine (EBM) requires the integration of the best research evidence with our clinical expertise and our patient's unique values and circumstances.The best evidence is valid and clinically relevant,especially from patient-centered clinical research.The clinical expertise means the ability to use our clinical skills and past experiences to rapidly identify each patient's unique health state and diagnosis,their individual risks,and the benefits of interventions (1)..

  18. Methyldibromo glutaronitrile: clinical experience and exposure-based risk assessment.

    Science.gov (United States)

    Zachariae, Claus; Rastogi, Suresh; Devantier, Charlotte; Menné, Torkil; Johansen, Jeanne Duus

    2003-03-01

    In the year 2000, the level of methyldibromo glutaronitrile (MDGN) allergy in dermatology clinics in Europe exceeded the level of allergies to all other preservatives, with a prevalence of 3.5%. In the present study, cases of primary sensitization and elicitation to MDGN due to cosmetic products were collected over an 8-month period at the Department of Dermatology, Gentofte University Hospital. The aim was to identify the products related to hand eczema, assess exposure to MDGN in these products and relate the findings to results from a newly developed updated risk assessment model for contact allergy. Out of 24 patients with a positive patch test to MDGN, 17 patients with hand eczema were identified. In 11 of these patients, cosmetic products used in relation to the onset of the disease were shown to contain MDGN (65%). In 8 of these 11 cases, primary sensitization was probable, 5 due to hand/body lotions and 3 due to lotions and/or liquid hand soap. Chemical analysis of 12 products showed that lotions contained 149-390 ppm of MDGN, liquid hand soap 144-399 ppm, a rinsing cream 293 ppm and shampoos 78-79 ppm. The shampoo exposure was not of certain relevance to the eczema. Applying the newly developed updated risk assessment model showed that the concentrations of MDGN in lotions of 149-390 ppm exceeded the calculated maximum acceptable exposure level for MDGN, which would be expected to lead to sensitization in consumers using such products, as seen in the current study. The present cases and updated exposure-based risk assessment process add to the evidence and need for re-defining safe-use concentrations of MDGN in cosmetic products.

  19. Management of posttraumatic brain swelling based on clinical typing

    Institute of Scientific and Technical Information of China (English)

    刘伟国; 裘五四; 沈宏; 王卫民

    2004-01-01

    Objective: To investigate the clinical typing and prophylactico-therapeutic measures for acute posttraumatic brain swelling (BS).Methods: A retrospective study was performed in 66 cases of acute posttraumatic BS. There were 3 groups based on computered tomography (CT) scanning: 23 cases of hemisphere brain swelling (HBS) with middle line shift for less than 5 mm within 24 hours ( Group A), 20 with middle line shift for more than 5 mm (Group B ), and 23 with bilateral diffuse brain swelling (Group C).Results : (1) The mortality rates of the operative and nonoperative management in Group A, Group B, and Group C were 20.0%, 31.6%, and 75.0% versus 44.4%,0, and 85.7 %, respectively ( P > 0.05 ); while the rates in subgroups with different middle line shift ( more than 5 mm and less or equal 5 mm) were 29.2% and 75.0% versus 75.0% and 44.4%, respectively (0.05 >P >0.01). (2) The good recovery rate and mortality in Group A were 47.8 % and 39.1%, respectively and in Group C, 8.7 % and 78.3%, respectively. There was a very significant difference between Group A and Group C (P <0.01). (3) The total survival rate of the selective comprehensive therapy was 53.1%.Conclusions : ( 1 ) Acute posttraumatic BS needs to be diagnosed correctly and promptly with CT scanning within 4 hours. (2) For patients with midline shift for more than 5 mm, especially with thin-layered subdural hematoma,surgical intervention is essential to reduce the fatality of acute posttraumatic BS.

  20. Person centered prediction of survival in population based screening program by an intelligent clinical decision support system.

    Science.gov (United States)

    Safdari, Reza; Maserat, Elham; Asadzadeh Aghdaei, Hamid; Javan Amoli, Amir Hossein; Mohaghegh Shalmani, Hamid

    2017-01-01

    To survey person centered survival rate in population based screening program by an intelligent clinical decision support system. Colorectal cancer is the most common malignancy and major cause of morbidity and mortality throughout the world. Colorectal cancer is the sixth leading cause of cancer death in Iran. In this survey, we used cosine similarity as data mining technique and intelligent system for estimating survival of at risk groups in the screening plan. In the first step, we determined minimum data set (MDS). MDS was approved by experts and reviewing literatures. In the second step, MDS were coded by python language and matched with cosine similarity formula. Finally, survival rate by percent was illustrated in the user interface of national intelligent system. The national intelligent system was designed in PyCharm environment. Main data elements of intelligent system consist demographic information, age, referral type, risk group, recommendation and survival rate. Minimum data set related to survival comprise of clinical status, past medical history and socio-demographic information. Information of the covered population as a comprehensive database was connected to intelligent system and survival rate estimated for each patient. Mean range of survival of HNPCC patients and FAP patients were respectively 77.7% and 75.1%. Also, the mean range of the survival rate and other calculations have changed with the entry of new patients in the CRC registry by real-time. National intelligent system monitors the entire of risk group and reports survival rates by electronic guidelines and data mining technique and also operates according to the clinical process. This web base software has a critical role in the estimation survival rate in order to health care planning.

  1. Ataluren: first global approval.

    Science.gov (United States)

    Ryan, Nicola J

    2014-09-01

    Nonsense mutations are implicated in 5-70 % of individual cases of most inherited diseases, including Duchenne muscular dystrophy (DMD) and cystic fibrosis. Ataluren (Translarna™) is an orally available, small molecule compound that targets nonsense mutations, and is the first drug in its class. Ataluren appears to allow cellular machinery to read through premature stop codons in mRNA, enabling the translation process to produce full-length, functional proteins. This article summarizes the milestones in the development of ataluren leading to its conditional first approval for nonsense mutation DMD.

  2. Establishment approval in international trade of animal products

    NARCIS (Netherlands)

    Rau, M.L.; Ge, L.; Valeeva, N.I.; Wagenberg, van C.P.A.

    2012-01-01

    This report provides an overview of different approaches of establishment approval as well as its implementation and organisation in international agrifood trade. The focus is on animal products as establishment approval is particularly used for exporting these products. Based on trade data, 8 count

  3. 21 CFR 1240.83 - Approval of watering points.

    Science.gov (United States)

    2010-04-01

    ... communicable diseases. (b) The Commissioner of Food and Drugs may base his approval or disapproval of a... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Approval of watering points. 1240.83 Section 1240.83 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  4. Evidence-based treatment of stuttering: III. Evidence-based practice in a clinical setting.

    Science.gov (United States)

    Langevin, Marilyn; Kully, Deborah

    2003-01-01

    At the heart of evidence-based practice in stuttering treatment are four issues: (1) the collection of data to inform treatment; (2) the long standing concern with maintenance of treatment gains; (3) the need to demonstrate accountability to clients, payers and our profession as service providers; and (4) the desire to advance theoretical knowledge. This article addresses the first three of these issues from a practical point of view, illustrating how data collection for stuttering treatment outcome research in a clinical setting is intimately blended with that required for clinical purposes and providing an example of a process of evaluating data for clinical and research purposes. The reader will learn about and be able to (1) differentiate between treatment outcome and treatment efficacy research, (2) describe models for integrating data collection for treatment outcome and clinical purposes, and (3) utilize guidelines for treatment efficacy that are applicable to outcome research to evaluate data for use in treatment outcome studies and to design outcome studies.

  5. Evaluation of mineral oil saturated hydrocarbons (MOSH and mineral oil aromatic hydrocarbons (MOAH in pure mineral hydrocarbon-based cosmetics and cosmetic raw materials using 1H NMR spectroscopy [version 1; referees: 2 approved, 1 approved with reservations

    Directory of Open Access Journals (Sweden)

    Dirk W. Lachenmeier

    2017-05-01

    Full Text Available Mineral hydrocarbons consist of two fractions, mineral oil saturated hydrocarbons (MOSH and mineral oil aromatic hydrocarbons (MOAH. MOAH is a potential public health hazard because it may include carcinogenic polycyclic compounds. In the present study, 400 MHz nuclear magnetic resonance (NMR spectroscopy was introduced, in the context of official controls, to measure MOSH and MOAH in raw materials or pure mineral hydrocarbon final products (cosmetics and medicinal products. Quantitative determination (qNMR has been established using the ERETIC methodology (electronic reference to access in vivo concentrations based on the PULCON principle (pulse length based concentration determination. Various mineral hydrocarbons (e.g., white oils, paraffins or petroleum jelly were dissolved in deuterated chloroform. The ERETIC factor was established using a quantification reference sample containing ethylbenzene and tetrachloronitrobenzene. The following spectral regions were integrated: MOSH δ 3.0 – 0.2 ppm and MOAH δ 9.2 - 6.5, excluding solvent signals. Validation showed a sufficient precision of the method with a coefficient of variation <6% and a limit of detection <0.1 g/100 g. The applicability of the method was proven by analysing 27 authentic samples with MOSH and MOAH contents in the range of 90-109 g/100 g and 0.02-1.10 g/100 g, respectively. It is important to distinguish this new NMR-approach from the hyphenated liquid chromatography-gas chromatography methodology previously used to characterize MOSH/MOAH amounts in cosmetic products. For mineral hydrocarbon raw materials or pure mineral hydrocarbon-based cosmetic products, NMR delivers higher specificity without any sample preparation besides dilution. Our sample survey shows that previous methods may have overestimated the MOAH amount in mineral oil products and opens new paths to characterize this fraction. Therefore, the developed method can be applied for routine monitoring of consumer

  6. Towards knowledge-based systems in clinical practice: development of an integrated clinical information and knowledge management support system.

    Science.gov (United States)

    Kalogeropoulos, Dimitris A; Carson, Ewart R; Collinson, Paul O

    2003-09-01

    Given that clinicians presented with identical clinical information will act in different ways, there is a need to introduce into routine clinical practice methods and tools to support the scientific homogeneity and accountability of healthcare decisions and actions. The benefits expected from such action include an overall reduction in cost, improved quality of care, patient and public opinion satisfaction. Computer-based medical data processing has yielded methods and tools for managing the task away from the hospital management level and closer to the desired disease and patient management level. To this end, advanced applications of information and disease process modelling technologies have already demonstrated an ability to significantly augment clinical decision making as a by-product. The wide-spread acceptance of evidence-based medicine as the basis of cost-conscious and concurrently quality-wise accountable clinical practice suffices as evidence supporting this claim. Electronic libraries are one-step towards an online status of this key health-care delivery quality control environment. Nonetheless, to date, the underlying information and knowledge management technologies have failed to be integrated into any form of pragmatic or marketable online and real-time clinical decision making tool. One of the main obstacles that needs to be overcome is the development of systems that treat both information and knowledge as clinical objects with same modelling requirements. This paper describes the development of such a system in the form of an intelligent clinical information management system: a system which at the most fundamental level of clinical decision support facilitates both the organised acquisition of clinical information and knowledge and provides a test-bed for the development and evaluation of knowledge-based decision support functions.

  7. Analysis of quality data based on national clinical databases

    DEFF Research Database (Denmark)

    Utzon, Jan; Petri, A.L.; Christophersen, S.

    2009-01-01

    extent the selection of patients, random variation, confounding and inconsistency may have influenced results. The aim of this article is to summarize aspects of clinical healthcare data analyses provided from the national clinical quality databases and to show how data may be presented in a way which......There is little agreement on the philosophy of measuring clinical quality in health care. How data should be analyzed and transformed to healthcare information is an ongoing discussion. To accept a difference in quality between health departments as a real difference, one should consider to which...

  8. Construction of a shared system-based real-world clinical research system.

    Science.gov (United States)

    Wu, Huikun; Li, Xiaodong; Yang, Fan; Xie, Dan; Li, Hui; Huang, Jingjing; Guo, Mingxing

    2014-09-01

    Hubei Provincial Hospital of Traditional Chinese Medicine established research outpatient clinics to contribute to the major disease-entity research conducted by the National Traditional Chinese Medicine Clinical Research Base and to the construction of the National Traditional Chinese Medicine Treatment and Clinical Research Information Sharing System. With a view of developing a "real-world traditional Chinese medicine clinical research paradigm," these clinics explored the mode of constructing research outpatient clinics from the aspects of clinical research, health management, and characteristics diagnosis and treatment.

  9. 77 FR 6535 - Notice of Intent To Seek Approval To Collect Information

    Science.gov (United States)

    2012-02-08

    ... National Agricultural Library Notice of Intent To Seek Approval To Collect Information AGENCY: National... extend currently approved data collection form. Abstract: This Web-based form collects information to.... Information collected includes the following: Preference of workshop date, signature, name,...

  10. An Integrative Pathway-based Clinical-genomic Model for Cancer Survival Prediction.

    Science.gov (United States)

    Chen, Xi; Wang, Lily; Ishwaran, Hemant

    2010-09-01

    Prediction models that use gene expression levels are now being proposed for personalized treatment of cancer, but building accurate models that are easy to interpret remains a challenge. In this paper, we describe an integrative clinical-genomic approach that combines both genomic pathway and clinical information. First, we summarize information from genes in each pathway using Supervised Principal Components (SPCA) to obtain pathway-based genomic predictors. Next, we build a prediction model based on clinical variables and pathway-based genomic predictors using Random Survival Forests (RSF). Our rationale for this two-stage procedure is that the underlying disease process may be influenced by environmental exposure (measured by clinical variables) and perturbations in different pathways (measured by pathway-based genomic variables), as well as their interactions. Using two cancer microarray datasets, we show that the pathway-based clinical-genomic model outperforms gene-based clinical-genomic models, with improved prediction accuracy and interpretability.

  11. Rule based Part of speech Tagger for Homoeopathy Clinical realm

    CERN Document Server

    Dwivedi, Sanjay K

    2011-01-01

    A tagger is a mandatory segment of most text scrutiny systems, as it consigned a s yntax class (e.g., noun, verb, adjective, and adverb) to every word in a sentence. In this paper, we present a simple part of speech tagger for homoeopathy clinical language. This paper reports about the anticipated part of speech tagger for homoeopathy clinical language. It exploit standard pattern for evaluating sentences, untagged clinical corpus of 20085 words is used, from which we had selected 125 sentences (2322 tokens). The problem of tagging in natural language processing is to find a way to tag every word in a text as a meticulous part of speech. The basic idea is to apply a set of rules on clinical sentences and on each word, Accuracy is the leading factor in evaluating any POS tagger so the accuracy of proposed tagger is also conversed.

  12. Evidenced-based review of clinical studies on periodontics.

    Science.gov (United States)

    2009-08-01

    Periodontal diseases have several implications for the practice of endodontics. First, advanced periodontitis often has direct implications for the long-term prognosis of the case and requires careful evaluation and coordinated treatment of both the periodontic and endodontic diseases. Second, the potential for functional interactions between odontogenic pathoses and marginal periodontitis requires careful collection of clinical observations and monitoring the outcome of various treatments. In this section, we provide an analysis of recent clinical studies in this area.

  13. Safinamide: first global approval.

    Science.gov (United States)

    Deeks, Emma D

    2015-04-01

    Safinamide (Xadago(®)) is an oral α-aminoamide derivative developed by Newron for the treatment of Parkinson's disease (PD). The drug has both dopaminergic properties (highly selective and reversible inhibition of monoamine oxidase-B) and non-dopaminergic properties (selective sodium channel blockade and calcium channel modulation, with consequent inhibition of excessive glutamate release). Safinamide is approved in the EU, Iceland, Lichtenstein and Norway, as an add-on therapy to stable-dose levodopa, alone or in combination with other PD therapies in mid- to late-stage fluctuating PD patients; regulatory submissions have also been filed in the USA and Switzerland for its use in this indication. Additional submissions have been made in the USA, Iceland, Lichtenstein, Norway and Switzerland for early-stage PD. Safinamide has also undergone phase II investigation in PD patients with drug-induced dyskinesia (France, Germany, Austria, Canada and South Africa) or cognitive impairment (USA and Spain). This article summarizes the milestones in the development of safinamide leading to its first approval for PD.

  14. Thermography based prescreening software tool for veterinary clinics

    Science.gov (United States)

    Dahal, Rohini; Umbaugh, Scott E.; Mishra, Deependra; Lama, Norsang; Alvandipour, Mehrdad; Umbaugh, David; Marino, Dominic J.; Sackman, Joseph

    2017-05-01

    Under development is a clinical software tool which can be used in the veterinary clinics as a prescreening tool for these pathologies: anterior cruciate ligament (ACL) disease, bone cancer and feline hyperthyroidism. Currently, veterinary clinical practice uses several imaging techniques including radiology, computed tomography (CT), and magnetic resonance imaging (MRI). But, harmful radiation involved during imaging, expensive equipment setup, excessive time consumption and the need for a cooperative patient during imaging, are major drawbacks of these techniques. In veterinary procedures, it is very difficult for animals to remain still for the time periods necessary for standard imaging without resorting to sedation - which creates another set of complexities. Therefore, clinical application software integrated with a thermal imaging system and the algorithms with high sensitivity and specificity for these pathologies, can address the major drawbacks of the existing imaging techniques. A graphical user interface (GUI) has been created to allow ease of use for the clinical technician. The technician inputs an image, enters patient information, and selects the camera view associated with the image and the pathology to be diagnosed. The software will classify the image using an optimized classification algorithm that has been developed through thousands of experiments. Optimal image features are extracted and the feature vector is then used in conjunction with the stored image database for classification. Classification success rates as high as 88% for bone cancer, 75% for ACL and 90% for feline hyperthyroidism have been achieved. The software is currently undergoing preliminary clinical testing.

  15. Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields

    Directory of Open Access Journals (Sweden)

    Hong-Jie Dai

    2015-01-01

    Full Text Available Electronic health record (EHR is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents.

  16. Recognition and Evaluation of Clinical Section Headings in Clinical Documents Using Token-Based Formulation with Conditional Random Fields

    Science.gov (United States)

    Dai, Hong-Jie; Syed-Abdul, Shabbir; Chen, Chih-Wei; Wu, Chieh-Chen

    2015-01-01

    Electronic health record (EHR) is a digital data format that collects electronic health information about an individual patient or population. To enhance the meaningful use of EHRs, information extraction techniques have been developed to recognize clinical concepts mentioned in EHRs. Nevertheless, the clinical judgment of an EHR cannot be known solely based on the recognized concepts without considering its contextual information. In order to improve the readability and accessibility of EHRs, this work developed a section heading recognition system for clinical documents. In contrast to formulating the section heading recognition task as a sentence classification problem, this work proposed a token-based formulation with the conditional random field (CRF) model. A standard section heading recognition corpus was compiled by annotators with clinical experience to evaluate the performance and compare it with sentence classification and dictionary-based approaches. The results of the experiments showed that the proposed method achieved a satisfactory F-score of 0.942, which outperformed the sentence-based approach and the best dictionary-based system by 0.087 and 0.096, respectively. One important advantage of our formulation over the sentence-based approach is that it presented an integrated solution without the need to develop additional heuristics rules for isolating the headings from the surrounding section contents. PMID:26380302

  17. No clinical evidence of acute opioid tolerance after remifentanil-based anaesthesia

    National Research Council Canada - National Science Library

    Cortínez, L I; Brandes, V; Muñoz, H R; Guerrero, M E; Mur, M

    2001-01-01

    We have prospectively assessed whether remifentanil-based anaesthesia is associated with clinically relevant acute opioid tolerance, expressed as greater postoperative pain scores or morphine consumption...

  18. Browser Based Platform in Maintaining Clinical Activities - Use of The iPads in Head and Neck Clinics

    Science.gov (United States)

    Yang, W. Y.; Moore, J.; Quon, H.; Evans, K.; Sharabi, A.; Herman, J.; Hacker-Prietz, A.; McNutt, T.

    2014-03-01

    Purpose: Incompatibility between documentation and clinical workflow causes physician resistance in organized data collection, which in turn complicates the use of data in patient care improvement. To resolve the gap, we developed an iPad compatible in situ browser-based platform that integrates clinical activity with data collection and analysis presentation. The ability to perform in-clinic activities and monitor decision making using the iPad was evaluated. Methods: A browser-based platform that can exchange and present analysed data from the MOSAIQ database was developed in situ, the iPads were distributed in head and neck clinics to present the browser for clinical activities, data collection and assessment monitoring. Performance of the iPads for in-clinic activities was observed. Results: All in-clinic documentation activities can be performed without workstation computers. Accessing patient record and previous assessments was significantly faster without having to open the MOSAIQ application. Patient assessments can be completed with the physician facing the patient. Graphical presentation of toxicity progression and patient radiation plans to the patient can be performed in single interface without patient leaving the seating area. Updates in patient treatment status and medical history were presented in real time without having to move paper charts around. Conclusions: The iPad can be used in clinical activities independent of computer workstations. Improvements in clinical workflow can be critical in reducing physician resistance in data maintenance. Using the iPad in providing real-time quality monitoring is intuitive to both providers and patients.

  19. Population-based clinical decision support: a clinical and economic evaluation.

    Science.gov (United States)

    Eisenstein, Eric L; Anstrom, Kevin J; Edwards, Rex; Willis, Janese M; Simo, Jessica; Lobach, David F

    2012-01-01

    Governments are investing in health information technologies (HIT) to improve care quality and reduce medical costs. However, evidence of these benefits is limited. We conducted a randomized trial of three clinical decision support (CDS) interventions in 20,180 patients: email to care managers (n=3329), reports to primary care administrators (n=3368), letters to patients (n=3401), and controls (10,082). At 7-month follow-up, the letters to patients group had greater use of outpatient services and higher outpatient and total medical costs; whereas, the other groups had no change in clinical events or medical costs. As our CDS interventions were associated with no change or an increase in medical costs, it appears that investments in HIT without consideration for organizational context may not be sufficient to achieve improvements in clinical and economic outcomes.

  20. Drugs Approved for Cervical Cancer

    Science.gov (United States)

    ... Human Papillomavirus (HPV) Nonavalent Vaccine Recombinant Human Papillomavirus (HPV) Quadrivalent Vaccine Drugs Approved to Treat Cervical Cancer Avastin (Bevacizumab) Bevacizumab Blenoxane (Bleomycin) Bleomycin Hycamtin (Topotecan ...

  1. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies.

    Science.gov (United States)

    O'Donnell, Lauren A; Perry, Michael W; Doup, Dane't R

    2015-12-01

    For many students in the health sciences, including doctor of pharmacy (PharmD) students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions), and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course.

  2. The Emerging Microbe Project: Developing Clinical Care Plans Based on Pathogen Identification and Clinical Case Studies

    Directory of Open Access Journals (Sweden)

    Lauren A. O'Donnell

    2015-08-01

    Full Text Available For many students in the health sciences, including doctor of pharmacy (PharmD students, basic and clinical sciences often appear detached from each other. In the infectious disease field, PharmD students additionally struggle with mastering the diversity of microorganisms and the corresponding therapies. The objective of this study was to design an interdisciplinary project that integrates fundamental microbiology with clinical research and decision-making skills. The Emerging Microbe Project guided students through the identification of a microorganism via genetic sequence analysis. The unknown microbe provided the basis for a patient case that asked the student to design a therapeutic treatment strategy for an infected patient. Outside of lecture, students had two weeks to identify the pathogen using nucleotide sequences, compose a microbiology report on the pathogen, and recommend an appropriate therapeutic treatment plan for the corresponding clinical case. We hypothesized that the students would develop a better understanding of the interplay between basic microbiology and infectious disease clinical practice, and that they would gain confidence and skill in independently selecting appropriate antimicrobial therapies for a new disease state. The exercise was conducted with PharmD students in their second professional year of pharmacy school in a required infectious disease course. Here, we demonstrate that the Emerging Microbe Project significantly improved student learning through two assessment strategies (assignment grades and exam questions, and increased student confidence in clinical infectious disease practice. This exercise could be modified for other health sciences students or undergraduates depending upon the level of clinical focus required of the course.

  3. Evidence-based practice for the busy nurse practitioner: part one: relevance to clinical practice and clinical inquiry process.

    Science.gov (United States)

    Facchiano, Lynda; Snyder, Charlene Hoffman

    2012-10-01

    Evidence-based practice (EBP) continues to gain momentum within health care. The purpose of this four-part EBP series is to provide an introductory overview of the EBP process, emphasizing EBP steps one through three, in order to assist nurse practitioners (NPs) in building EBP skills that can be integrated into clinical practice. The relevance of EBP to the NP's clinical practice, an introduction to the EBP process steps, and clinical inquiry process begin the series. Scientific literature review, gray literature, and online evidence-based practice databases and resources. EBP has become increasingly important to NPs, yet there is evidence suggesting it is not being fully implemented in clinical practice. EBP is one way to keep the busy NP's knowledge up to date, enhance clinical judgment, and augment the existing provider-client decision-making process. The principles of EBP have become the cornerstone strategy for NPs to translate research findings into clinical practice. Practicing in an ever-changing healthcare environment, NPs have a responsibility to provide their clients with the best available evidence, while incorporating that evidence into the provider-client decision-making process. ©2012 The Author(s) Journal compilation ©2012 American Academy of Nurse Practitioners.

  4. Effect of exposure to clinic-based health education interventions on ...

    African Journals Online (AJOL)

    to-child transmission (PMTCT) interventions is often said to be dependent on the ... This study therefore sought to examine the effect of clinic-based health .... Ensuring behaviour change through health education ... around 30 clinics, mobile clinics and community health ... participants' age, marital status, number of children,.

  5. Trustworthiness and relevance in web-based clinical question answering.

    Science.gov (United States)

    Cruchet, Sarah; Boyer, Célia; van der Plas, Lonneke

    2012-01-01

    Question answering systems try to give precise answers to a user's question posed in natural language. It is of utmost importance that the answers returned are relevant to the user's question. For clinical QA, the trustworthiness of answers is another important issue. Limiting the document collection to certified websites helps to improve the trustworthiness of answers. On the other hand, limited document collections are known to harm the relevancy of answers. We show, however, in a comparative evaluation, that promoting trustworthiness has no negative effect on the relevance of the retrieved answers in our clinical QA system. On the contrary, the answers found are in general more relevant.

  6. [Clinical-metabolic data base on chronic generalized parodontitis].

    Science.gov (United States)

    Gil'miiarov, E M; Berezhnoĭ, V P; Gil'miiarova, I E; Tlustenko, V P

    2008-01-01

    As the result of clinical-lab study of 40 oral fluid parameters in 176 patients new block of data was received disclosing key pathogenetic links of chronic generalized parodontitis (CGP) to which could be attributed endocrine dysfunction with cortisol level reduction and free thyroid hormones increase, enforcing prooxidant processes with multiple iron content increase. As the result of it molecules of medium mass were accumulated; protein spectrum, protein coupling capacity, content of collagenous C-peptide, osteocalcine, Ca, P and Mg were changing. In comprehensive CGP treatment due to Natursyl (lipophilic fraction of holy thistle) applications the disease clinical signs disappeared quicker and biochemical markers normalized.

  7. Saliva-based biosensors: noninvasive monitoring tool for clinical diagnostics.

    Science.gov (United States)

    Malon, Radha S P; Sadir, Sahba; Balakrishnan, Malarvili; Córcoles, Emma P

    2014-01-01

    Saliva is increasingly recognised as an attractive diagnostic fluid. The presence of various disease signalling salivary biomarkers that accurately reflect normal and disease states in humans and the sampling benefits compared to blood sampling are some of the reasons for this recognition. This explains the burgeoning research field in assay developments and technological advancements for the detection of various salivary biomarkers to improve clinical diagnosis, management, and treatment. This paper reviews the significance of salivary biomarkers for clinical diagnosis and therapeutic applications, with focus on the technologies and biosensing platforms that have been reported for screening these biomarkers.

  8. Saliva-Based Biosensors: Noninvasive Monitoring Tool for Clinical Diagnostics

    Directory of Open Access Journals (Sweden)

    Radha S. P. Malon

    2014-01-01

    Full Text Available Saliva is increasingly recognised as an attractive diagnostic fluid. The presence of various disease signalling salivary biomarkers that accurately reflect normal and disease states in humans and the sampling benefits compared to blood sampling are some of the reasons for this recognition. This explains the burgeoning research field in assay developments and technological advancements for the detection of various salivary biomarkers to improve clinical diagnosis, management, and treatment. This paper reviews the significance of salivary biomarkers for clinical diagnosis and therapeutic applications, with focus on the technologies and biosensing platforms that have been reported for screening these biomarkers.

  9. Available Tools to Facilitate Early Patient Access to Medicines in the EU and the USA: Analysis of Conditional Approvals and the Implications for Personalized Medicine.

    Science.gov (United States)

    Leyens, Lada; Richer, Étienne; Melien, Øyvind; Ballensiefen, Wolfgang; Brand, Angela

    2015-01-01

    Scientific knowledge and our understanding of the human body and diseases have limited any possible treatment tailoring to each patient. The technological advances enabling the integration of various data sets (e.g. '-omics', microbiome, epigenetics and environmental exposure) have facilitated a greater understanding of the human body, the molecular basis of disease and all the factors influencing disease onset, progression and response to treatment, thereby ushering in the era of personalized medicine. We evaluate the regulatory approaches available to facilitate early patient access to efficacious and safe compounds in the EU and the USA in order to make more informed recommendations in the future as to the gaps in regulations for early patient access. An in-depth analysis of conditional approvals (EU) and accelerated approvals (USA) is performed based on the publicly available information (European public assessment reports and a summary review of products approved under both programmes). The types of product, indications, time to approval and type of evidence submitted were analysed. Between 2007 and early 2015, 17 products were conditionally approved in the EU and 25 in the USA, most of them in the area of oncology and based on evidence from phase II clinical trial data. Early approval of promising products based on data from early phases of development is already possible in the EU and the USA. Some of the improvements could entail implementing a rolling assessment of evidence in Europe and extending the scope of early dialogues.

  10. Performance-Based Assessment of Clinical Ethics Using an Objective Structured Clinical Examination.

    Science.gov (United States)

    Singer, Peter A.; And Others

    1996-01-01

    Final-year Ontario medical students (n=88) took a 4-station objective structured clinical examination (OSCE) using standardized patients and involving decisions to forgo life-sustaining treatment. Performance was scored on a checklist of behaviors unique to each case. Results indicated that because of low reliability, the OSCE is not a feasible…

  11. Performance-Based Assessment of Clinical Ethics Using an Objective Structured Clinical Examination.

    Science.gov (United States)

    Singer, Peter A.; And Others

    1996-01-01

    Final-year Ontario medical students (n=88) took a 4-station objective structured clinical examination (OSCE) using standardized patients and involving decisions to forgo life-sustaining treatment. Performance was scored on a checklist of behaviors unique to each case. Results indicated that because of low reliability, the OSCE is not a feasible…

  12. A service oriented approach for guidelines-based clinical decision support using BPMN.

    Science.gov (United States)

    Rodriguez-Loya, Salvador; Aziz, Ayesha; Chatwin, Chris

    2014-01-01

    Evidence-based medical practice requires that clinical guidelines need to be documented in such a way that they represent a clinical workflow in its most accessible form. In order to optimize clinical processes to improve clinical outcomes, we propose a Service Oriented Architecture (SOA) based approach for implementing clinical guidelines that can be accessed from an Electronic Health Record (EHR) application with a Web Services enabled communication mechanism with the Enterprise Service Bus. We have used Business Process Modelling Notation (BPMN) for modelling and presenting the clinical pathway in the form of a workflow. The aim of this study is to produce spontaneous alerts in the healthcare workflow in the diagnosis of Chronic Obstructive Pulmonary Disease (COPD). The use of BPMN as a tool to automate clinical guidelines has not been previously employed for providing Clinical Decision Support (CDS).

  13. Implementation outcomes of evidence-based quality improvement for depression in VA community based outpatient clinics

    Directory of Open Access Journals (Sweden)

    Fortney John

    2012-04-01

    Full Text Available Abstract Background Collaborative-care management is an evidence-based practice for improving depression outcomes in primary care. The Department of Veterans Affairs (VA has mandated the implementation of collaborative-care management in its satellite clinics, known as Community Based Outpatient Clinics (CBOCs. However, the organizational characteristics of CBOCs present added challenges to implementation. The objective of this study was to evaluate the effectiveness of evidence-based quality improvement (EBQI as a strategy to facilitate the adoption of collaborative-care management in CBOCs. Methods This nonrandomized, small-scale, multisite evaluation of EBQI was conducted at three VA Medical Centers and 11 of their affiliated CBOCs. The Plan phase of the EBQI process involved the localized tailoring of the collaborative-care management program to each CBOC. Researchers ensured that the adaptations were evidence based. Clinical and administrative staff were responsible for adapting the collaborative-care management program for local needs, priorities, preferences and resources. Plan-Do-Study-Act cycles were used to refine the program over time. The evaluation was based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance Framework and used data from multiple sources: administrative records, web-based decision-support systems, surveys, and key-informant interviews. Results Adoption: 69.0% (58/84 of primary care providers referred patients to the program. Reach: 9.0% (298/3,296 of primary care patients diagnosed with depression who were not already receiving specialty care were enrolled in the program. Fidelity: During baseline care manager encounters, education/activation was provided to 100% (298/298 of patients, barriers were assessed and addressed for 100% (298/298 of patients, and depression severity was monitored for 100% (298/298 of patients. Less than half (42.5%, 681/1603 of follow-up encounters during the acute

  14. Vaccine-based clinical trials in ovarian cancer

    NARCIS (Netherlands)

    Leffers, Ninke; Daemen, Toos; Boezen, H. Marike; Melief, Kees J. M.; Nijman, Hans W.

    2011-01-01

    Ovarian cancer vaccines are one of the new treatment strategies under investigation in epithelial ovarian cancer. This article discusses the results of different immunization strategies, points out potential pitfalls in study designs and provides possible solutions for augmentation of clinical effic

  15. A Semantic Web-based System for Managing Clinical Archetypes.

    Science.gov (United States)

    Fernandez-Breis, Jesualdo Tomas; Menarguez-Tortosa, Marcos; Martinez-Costa, Catalina; Fernandez-Breis, Eneko; Herrero-Sempere, Jose; Moner, David; Sanchez, Jesus; Valencia-Garcia, Rafael; Robles, Montserrat

    2008-01-01

    Archetypes facilitate the sharing of clinical knowledge and therefore are a basic tool for achieving interoperability between healthcare information systems. In this paper, a Semantic Web System for Managing Archetypes is presented. This system allows for the semantic annotation of archetypes, as well for performing semantic searches. The current system is capable of working with both ISO13606 and OpenEHR archetypes.

  16. A comprehensive clinical competency-based assessment in periodontics.

    Science.gov (United States)

    Shiloah, J; Scarbecz, M; Bland, P S; Hottel, T L

    2017-05-01

    Traditional periodontics clinical examinations in dental education frequently assess a narrow set of clinical skills and do not adequately assess the ability of students to independently manage a periodontal patient. As an alternative, the authors developed a comprehensive periodontics competency case experience (CCCE) for senior dental students and surveyed students regarding their experience with the CCCE. Students challenging the CCCE must treat a patient with moderate periodontitis and must independently decide when a state of periodontal and oral health has been achieved. Students are also required to conduct an oral presentation to periodontology faculty. Dental students who completed the CCCE had a favourable impression of the experience, compared with the traditional clinical examinations taken in the junior year. The majority of students rated all the components of the CCCE as 'somewhat' or 'very helpful'. About 72.4% of students felt that being able to work independently on the examination was very helpful for learning about the clinical management of patients with periodontal disease, followed by 'simulation of care in private practice' (65.5%), and oral photography experience (55.2%). The greatest difficulty reported by students was finding an acceptable patient. About 62.1% of students rated 'finding the right patient' as very difficult. Students reported having to screen a mean of 5.9 patients (SD: 4.5) to find a qualified patient. The results of the survey will be useful in improving the examination as an assessment tool in periodontal therapy.

  17. Clinical study of model-based blood flow quantification on cerebrovascular data

    NARCIS (Netherlands)

    Groth, A.; Wächter-Stehle, I.; Brina, O.; Perren. F.; Rüfenacht, D.; Bruijns, T.; Bertram, M.; Weese, J.

    2011-01-01

    Diagnosis and treatment decisions of cerebrovascular diseases are currently based on structural information like the endovascular lumen. In future, clinical diagnosis will increasingly be based on functional information which gives direct information about the physiological parameters and, hence, is

  18. Are the outcomes of clinical pathways evidence-based? A critical appraisal of clinical pathway evaluation research

    NARCIS (Netherlands)

    El Baz, N.; Middel, B.; Van Dijk, J.P.; Oosterhof, A.; Boonstra, P.W.; Reijneveld, S.A.

    2007-01-01

    Aim and objective To evaluate the validity of study outcomes of published papers that report the effects of clinical pathways (CP). Method Systematic review based on two search strategies, including searching Medline, CINAHL, Embase, Psychinfo and Picarta from 1995 till 2005 and ISI Web of Knowledge

  19. Clinical review: Reunification of acid–base physiology

    OpenAIRE

    2005-01-01

    Recent advances in acid–base physiology and in the epidemiology of acid–base disorders have refined our understanding of the basic control mechanisms that determine blood pH in health and disease. These refinements have also brought parity between the newer, quantitative and older, descriptive approaches to acid–base physiology. This review explores how the new and older approaches to acid–base physiology can be reconciled and combined to result in a powerful bedside tool. A case based tutori...

  20. Development of Clinic Specific Physical Therapy Efficiency Targets Based on Clinic Specific Metrics

    Science.gov (United States)

    2009-04-24

    efficiency ratings in the PBAM model which inflates the monetary budget adjustment for the MTF under the orthopedic product line. Developing individual... Veterinarians IF Fellow-Medical 1R Resident-Medical IS Intern-Dental IT Fellow-Dental 1U Resident-Dental IV Veterinarian 2 Direct Care Professional 2P...concerned with the Physical Therapy clinic under the Orthopedic (ORTHO) primary product line within the ambulatory section of the Product Line

  1. Developing Clinical Competency in Crisis Event Management: An Integrated Simulation Problem-Based Learning Activity

    Science.gov (United States)

    Liaw, S. Y.; Chen, F. G.; Klainin, P.; Brammer, J.; O'Brien, A.; Samarasekera, D. D.

    2010-01-01

    This study aimed to evaluate the integration of a simulation based learning activity on nursing students' clinical crisis management performance in a problem-based learning (PBL) curriculum. It was hypothesized that the clinical performance of first year nursing students who participated in a simulated learning activity during the PBL session…

  2. A Comparison of Urban School- and Community-Based Dental Clinics

    Science.gov (United States)

    Larsen, Charles D.; Larsen, Michael D.; Handwerker, Lisa B.; Kim, Maile S.; Rosenthal, Murray

    2009-01-01

    Background: The objective of the study was to quantitatively compare school- and community-based dental clinics in New York City that provide dental services to children in need. It was hypothesized that the school-based clinics would perform better in terms of several measures. Methods: We reviewed billing and visit data derived from encounter…

  3. An Exploration of the Base Rate Scores of the Millon Clinical Multiaxial Inventory-III

    Science.gov (United States)

    Grove, William M.; Vrieze, Scott I.

    2009-01-01

    The Millon Clinical Multiaxial Inventory (3rd ed.; MCMI-III) is a widely used psychological assessment of clinical and personality disorders. Unlike typical tests, the MCMI-III uses a base-rate score transformation to incorporate prior probabilities of disorder (i.e., base rates) in test output and diagnostic thresholds. The authors describe the…

  4. A Comparison of Urban School- and Community-Based Dental Clinics

    Science.gov (United States)

    Larsen, Charles D.; Larsen, Michael D.; Handwerker, Lisa B.; Kim, Maile S.; Rosenthal, Murray

    2009-01-01

    Background: The objective of the study was to quantitatively compare school- and community-based dental clinics in New York City that provide dental services to children in need. It was hypothesized that the school-based clinics would perform better in terms of several measures. Methods: We reviewed billing and visit data derived from encounter…

  5. Developing Clinical Competency in Crisis Event Management: An Integrated Simulation Problem-Based Learning Activity

    Science.gov (United States)

    Liaw, S. Y.; Chen, F. G.; Klainin, P.; Brammer, J.; O'Brien, A.; Samarasekera, D. D.

    2010-01-01

    This study aimed to evaluate the integration of a simulation based learning activity on nursing students' clinical crisis management performance in a problem-based learning (PBL) curriculum. It was hypothesized that the clinical performance of first year nursing students who participated in a simulated learning activity during the PBL session…

  6. FDA-Approved HIV Medicines

    Science.gov (United States)

    HIV Treatment FDA-Approved HIV Medicines (Last updated 2/27/2017; last reviewed 2/27/2017) Treatment with HIV medicines is ... approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in the ...

  7. Application of a PK-PD Modeling and Simulation-Based Strategy for Clinical Translation of Antibody-Drug Conjugates: a Case Study with Trastuzumab Emtansine (T-DM1).

    Science.gov (United States)

    Singh, Aman P; Shah, Dhaval K

    2017-04-03

    Successful clinical translation of antibody-drug conjugates (ADCs) can be challenging due to complex pharmacokinetics and differences between preclinical and clinical tumors. To facilitate this translation, we have developed a general pharmacokinetic-pharmacodynamic (PK-PD) modeling and simulation (M&S)-based strategy for ADCs. Here we present the validation of this strategy using T-DM1 as a case study. A previously developed preclinical tumor disposition model for T-DM1 (Singh and Shah, AAPSJ. 2015; 18(4):861-875) was used to develop a PK-PD model that can characterize in vivo efficacy of T-DM1 in preclinical tumor models. The preclinical data was used to estimate the efficacy parameters for T-DM1. Human PK of T-DM1 was a priori predicted using allometric scaling of monkey PK parameters. The predicted human PK, preclinically estimated efficacy parameters, and clinically observed volume and growth parameters for breast cancer were combined to develop a translated clinical PK-PD model for T-DM1. Clinical trial simulations were performed using the translated PK-PD model to predict progression-free survival (PFS) and objective response rates (ORRs) for T-DM1. The model simulated PFS rates for HER2 1+ and 3+ populations were comparable to the rates observed in three different clinical trials. The model predicted only a modest improvement in ORR with an increase in clinically approved dose of T-DM1. However, the model suggested that a fractionated dosing regimen (e.g., front loading) may provide an improvement in the efficacy. In general, the PK-PD M&S-based strategy presented here is capable of a priori predicting the clinical efficacy of ADCs, and this strategy has been now retrospectively validated for all clinically approved ADCs.

  8. Spirulina in clinical practice: evidence-based human applications.

    Science.gov (United States)

    Karkos, P D; Leong, S C; Karkos, C D; Sivaji, N; Assimakopoulos, D A

    2011-01-01

    Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed.

  9. Spirulina in Clinical Practice: Evidence-Based Human Applications

    Directory of Open Access Journals (Sweden)

    P. D. Karkos

    2011-01-01

    Full Text Available Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and systematic reviews suggest that this alga may improve several symptoms and may even have an anticancer, antiviral and antiallergic effects. Current and potential clinical applications, issues of safety, indications, side-effects and levels of evidence are addressed in this review. Areas of ongoing and future research are also discussed.

  10. Internet in clinical research based on a pilot experience.

    Science.gov (United States)

    López-Carrero, Carmen; Arriaza, Elena; Bolaños, Elena; Ciudad, Antonio; Municio, Marco; Ramos, José; Hesen, Wout

    2005-04-01

    Computing has become an integral part of many disciplines nowadays, turning it into an evermore necessary working tool. Internet provides a fast and easy way to collect scientific data and is becoming a more and more effective and safe way to transmit data. It is also an efficient means for interaction and information sharing within a work group that provides the necessary flexibility. A pilot project was conducted replacing the traditional hardcopy version of the case report form for an electronic one (e-CRF) and with access to Internet within the Naturalistic Randomized Clinical Trial of the Effectiveness of Olanzapine and Risperidone in the Treatment of Schizophrenia. Carrying out this pilot project has given us the opportunity to determine the advantages electronic data collection (EDC) by Internet has to offer both researchers and sponsors. The results have optimized time management, since it is easier to work in real time; data quality is improved, since intermediates are eliminated, and it facilitates communication amongst the different parties involved in the project. The use of this technology requires updated Internet connections and adequate personal computers, since the possibilities offered by the computer system and high-speed connection are critical in conducting the project. Obviously, this may involve a higher initial investment, but the results have revealed to us that these start-up costs are later offset by lowering personnel costs or by decreasing the number of monitoring visits. On the basis of our experience and that of the participating investigators, certain recommendations for future clinical trials using e-CRF can be made. We will go into these recommendations in greater depth throughout this paper. In short, EDC can dramatically improve the clinical trial process, opening the door to new technologies in the world of clinical research, not only for sponsors, but also for clinicians.

  11. Novel phosphate-based cements for clinical applications

    OpenAIRE

    2012-01-01

    This Thesis aims at the development of two novel families of inorganic phosphate cements with suitable characteristics for clinical applications in hard tissue regeneration or replacement. It is organized in two distinct parts. The first part focuses at the development of silicon-doped a-tricalcium phosphate and the subsequent preparation of a silicon-doped calcium phosphate cement for bone regeneration applications. For this purpose, silicon-doped a-tricalcium phosphate was synthesized b...

  12. Spirulina in Clinical Practice: Evidence-Based Human Applications

    OpenAIRE

    Karkos, P. D.; Leong, S. C.; C. D. Karkos; Sivaji, N.; Assimakopoulos, D. A.

    2011-01-01

    Spirulina or Arthrospira is a blue-green alga that became famous after it was successfully used by NASA as a dietary supplement for astronauts on space missions. It has the ability to modulate immune functions and exhibits anti-inflammatory properties by inhibiting the release of histamine by mast cells. Multiple studies investigating the efficacy and the potential clinical applications of Spirulina in treating several diseases have been performed and a few randomized controlled trials and sy...

  13. [Pertuzumab (Perjeta®) approval in HER2-positive metastatic breast cancers].

    Science.gov (United States)

    Sabatier, Renaud; Gonçalves, Anthony

    2014-01-01

    Fifteen to 20% of breast cancers display HER2 amplification. Many therapeutic successes have been obtained for this subtype in the last decade since trastuzumab approval for metastatic and localized diseases. Pertuzumab, a new anti-HER2 antibody, has been approved in 2013 by the European Medicine Agency. This drug can be used in combination with trastuzumab and docetaxel for the first line treatment of metastatic or locally recurrent non resecable HER2-positive breast cancers not previously treated by chemotherapy or HER2-inhibitors in the metastatic setting. This approval has been done after the CLEOPATRA trial results. This was a randomized, double-blind, multicentre, phase III trial evaluating the standard treatment (trastuzumab plus docetaxel) associated to pertuzumab or placebo. The authors have reported a statistically significant and clinically relevant benefit for the pertuzumab-based treatment. Median progression-free survival was 18.4 for the pertuzumab arm versus 12.5 months for the control group (p<0.001). They also observed benefits concerning the secondary endpoints: overall response rate and overall survival. Patients receiving pertuzumab presented more frequent diarrhea and febrile neutropenia but no increase in cardiac events. This drug has already been evaluated in the neoadjuvant setting with a FDA approval recently obtained. Its use in the adjuvant setting is under evaluation.

  14. Thiazolidinediones: a comparative review of approved uses.

    Science.gov (United States)

    Sood, V; Colleran, K; Burge, M R

    2000-01-01

    Thiazolidinediones are a powerful and clinically important new class of oral antidiabetic agents that act by improving insulin sensitivity. Troglitazone is the prototype drug in this class but was withdrawn from the market in March 2000 due to its association with idiosyncratic hepatotoxicity. Currently two thiazolidinediones, rosiglitazone and pioglitazone, are U.S. Food and Drug Administration (FDA) approved for treatment of type 2 diabetes. These agents bind to and activate peroxisome proliferator-activator receptor gamma (PPAR-gamma) and work by altering the expression of genes involved in glucose uptake, glucose disposal, and lipid metabolism. The drugs differ in receptor binding and potency due to differences in their side chain moieties. These agents are rapidly absorbed from the gastrointestinal tract and are metabolized mainly in the liver. Rosiglitazone is FDA approved for monotherapy and for use in combination therapy with metformin or sulfonylureas. Pioglitazone is FDA approved for monotherapy as well as for use in combination therapy with metformin, insulin, or sulfonylureas. These drugs may also cause significant changes in plasma lipid concentrations, and improved insulin sensitivity may improve ovulatory function and fertility in women with polycystic ovary syndrome. The most serious side effect of the thiazolidinediones is hepatotoxicity. Although rosiglitazone and pioglitazone were not associated with hepatotoxicity in premarketing clinical trials, there were two recent case reports of idiosyncratic hepatotoxicity in patients treated with rosiglitazone. In addition, these agents may be associated with edema and some hematological changes. The purpose of this review is to provide an overview of the two currently approved thiazolidinediones and to suggest an approach for their safe and rational use.

  15. [The historical background and present development of evidence-based healthcare and clinical nursing].

    Science.gov (United States)

    Tsai, Jung-Mei

    2014-12-01

    Evidence-based healthcare (EBHC) emphasizes the integration of the best research evidence with patient values, specialist suggestions, and clinical circumstances during the process of clinical decision-making. EBHC is a recognized core competency in modern healthcare. Nursing is a professional discipline of empirical science that thrives in an environment marked by advances in knowledge and technology in medicine as well as in nursing. Clinical nurses must elevate their skills and professional qualifications, provide efficient and quality health services, and promote their proficiency in EBHC. The Institute of Medicine in the United States indicates that evidence-based research results often fail to disseminate efficiently to clinical decision makers. This problem highlights the importance of better promoting the evidence-based healthcare fundamentals and competencies to frontline clinical nurses. This article describes the historical background and present development of evidence-based healthcare from the perspective of modern clinical nursing in light of the importance of evidence-based healthcare in clinical nursing; describes the factors associated with evidence-based healthcare promotion; and suggests strategies and policies that may improve the promotion and application of EBHC in clinical settings. The authors hope that this paper provides a reference for efforts to improve clinical nursing in the realms of EBHC training, promotion, and application.

  16. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2004-01-01

    With a view to the simplification of administrative procedures, AS and FI Departments have completed the second phase of the new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. Phase II includes handling the electronic approval process of invoices whose amounts do not correspond exactly to those of the associated orders. In such cases, budgetary approval is required for the entire invoiced amount. Further information can be obtained at : http://ais.cern.ch/projs/AEF/help/F_help.htm Phase II of the procedure will be introduced gradually with effect from April 2004. Finance Department, Accounts Payable Section Tel: 72295 Organisation and Procedures Tel: 75885 Information Technologies Department,...

  17. 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.

  18. Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union.

    Science.gov (United States)

    Jokura, Yoji; Yano, Kazuo; Yamato, Masayuki

    2017-02-17

    Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd. Copyright © 2017 The Authors. Tissue

  19. 基于SOA架构的并联审批系统的设计与实现%Desing and lmplementation of a parallel approval system based on SOA

    Institute of Scientific and Technical Information of China (English)

    李天尘; 周亮亮; 冯园园

    2013-01-01

    针对上海市组织机构代码中心作为质监并联审批部门的业务特点,根据《上海市并联审批试行办法》中对上海市内资企业设立网上并联审批平台的建设要求,对面向服务的体系结构SOA进行研究,在对SOA的关键技术和数据交换方法充分了解后,采用SOA技术进行平台的基本架构设计和系统的设计与实现,达成了并联审批业务流程设计目标,确保了内资企业基础信息的准确、完整、一致,提升了内资企业新设立受理业务的审批效率。%This paper introduces a parallel approval system based on Service-Oriented Architecture (SOA). According to the characteristics of Shanghai Organization Code Center operation system and the“Measure of Shanghai Parallel Approval System”, the system is designed and built to join up with the online platform of Shanghai Parallel Approval for Domestic Enterprises Set-up, combined with various data exchange services. The system meets the aim of construction, optimized the business process, improved the supervision and service level of E-government, shorten the issue cycle of organization code certificate.

  20. Phage approved in food, why not as a therapeutic?

    Science.gov (United States)

    Sarhan, Wessam A; Azzazy, Hassan M E

    2015-01-01

    Bacterial resistance is not only restricted to human infections but is also a major problem in food. With the marked decrease in produced antimicrobials, the world is now reassessing bacteriophages. In 2006, ListShield™ received the US FDA approval for using phage in food. Nevertheless, regulatory approval of phage-based therapeutics is still facing many challenges. This review highlights the use of bacteriophages as biocontrol agents in the food industry. It also focuses on the challenges still facing the regulatory approval of phage-based therapeutics and the proposed approaches to overcome such challenges.

  1. A Clinic-based Survey of Clinical Characteristics and Practice Pattern of Dry Eye in Japan.

    Science.gov (United States)

    Kawashima, Motoko; Yamada, Masakazu; Suwaki, Kazuhisa; Shigeyasu, Chika; Uchino, Miki; Hiratsuka, Yoshimune; Yokoi, Norihiko; Tsubota, Kazuo

    2017-03-01

    The aim of this study was to investigate the clinical characteristics and practice pattern of patients with dry eye disease (DED) in eye clinics across Japan. A multi-center, cross-sectional study was conducted among patients with DED who visited eye clinics in Japan. Subjective symptoms, patient's background, ocular surface features, and tear function were evaluated. Main outcome measures were tear break-up time (TBUT), Schirmer I value, kerato-conjunctival staining score, and dry eye symptom questionnaire score. Initially, 463 subjects were enrolled, and 449 cases (63 male and 386 female; mean age, 62.6 ± 15.7 years) were included in the final analysis. Overall, 94.9% of patients had a shortened TBUT (≤5 s), and 54.6% had an aqueous tear deficiency (Schirmer I value ≤5 mm). The most prevalent subtype of dry eye was aqueous-deficient dry eye, which was present in 35.0% of all patients, followed by short-BUT-type dry eye, which was seen in 26.7%. The two most common DED subtypes were aqueous-deficient and short-BUT-type dry eye. Shortened TBUT is the most common feature of dry eye, regardless of subtype. The current treatment choice mainly consisted of hyaluronic acid, two novel mucin secretagogues, diquafosol and rebamipide, and steroidal eye drops. University Hospital Medical Information Network: UMIN (registries no. UMIN 000015890). Japan Dry Eye Society, Tokyo, Japan, and Santen Pharmaceutical Co., Ltd., Osaka, Japan.

  2. Reliability and accuracy of dermatologists' clinic-based and digital image consultations.

    Science.gov (United States)

    Whited, J D; Hall, R P; Simel, D L; Foy, M E; Stechuchak, K M; Drugge, R J; Grichnik, J M; Myers, S A; Horner, R D

    1999-11-01

    Telemedicine technology holds great promise for dermatologic health care delivery. However, the clinical outcomes of digital image consultations (teledermatology) must be compared with traditional clinic-based consultations. Our purpose was to assess and compare the reliability and accuracy of dermatologists' diagnoses and management recommendations for clinic-based and digital image consultations. One hundred sixty-eight lesions found among 129 patients were independently examined by 2 clinic-based dermatologists and 3 different digital image dermatologist consultants. The reliability and accuracy of the examiners' diagnoses and the reliability of their management recommendations were compared. Proportion agreement among clinic-based examiners for their single most likely diagnosis was 0. 54 (95% confidence interval [CI], 0.46-0.61) and was 0.92 (95% CI, 0. 88-0.96) when ratings included differential diagnoses. Digital image consultants provided diagnoses that were comparably reliable to the clinic-based examiners. Agreement on management recommendations was variable. Digital image and clinic-based consultants displayed similar diagnostic accuracy. Digital image consultations result in reliable and accurate diagnostic outcomes when compared with traditional clinic-based consultations.

  3. Development of the Computerized Model of Performance-Based Measurement System to Measure Nurses' Clinical Competence.

    Science.gov (United States)

    Liou, Shwu-Ru; Liu, Hsiu-Chen; Tsai, Shu-Ling; Cheng, Ching-Yu; Yu, Wei-Chieh; Chu, Tsui-Ping

    2016-04-01

    Critical thinking skills and clinical competence are for providing quality patient care. The purpose of this study is to develop the Computerized Model of Performance-Based Measurement system based on the Clinical Reasoning Model. The system can evaluate and identify learning needs for clinical competency and be used as a learning tool to increase clinical competency by using computers. The system includes 10 high-risk, high-volume clinical case scenarios coupled with questions testing clinical reasoning, interpersonal, and technical skills. Questions were sequenced to reflect patients' changing condition and arranged by following the process of collecting and managing information, diagnosing and differentiating urgency of problems, and solving problems. The content validity and known-groups validity was established. The Kuder-Richardson Formula 20 was 0.90 and test-retest reliability was supported (r = 0.78). Nursing educators can use the system to understand students' needs for achieving clinical competence, and therefore, educational plans can be made to better prepare students and facilitate their smooth transition to a future clinical environment. Clinical nurses can use the system to evaluate their performance-based abilities and weakness in clinical reasoning. Appropriate training programs can be designed and implemented to practically promote nurses' clinical competence and quality of patient care.

  4. Personalized Clinical Diagnosis in Data Bases for Treatment Support in Phthisiology.

    Science.gov (United States)

    Lugovkina, T K; Skornyakov, S N; Golubev, D N; Egorov, E A; Medvinsky, I D

    2016-01-01

    The decision-making is a key event in the clinical practice. The program products with clinical decision support models in electronic data-base as well as with fixed decision moments of the real clinical practice and treatment results are very actual instruments for improving phthisiological practice and may be useful in the severe cases caused by the resistant strains of Mycobacterium tuberculosis. The methodology for gathering and structuring of useful information (critical clinical signals for decisions) is described. Additional coding of clinical diagnosis characteristics was implemented for numeric reflection of the personal situations. The created methodology for systematization and coding Clinical Events allowed to improve the clinical decision models for better clinical results.

  5. Team-based learning, a learning strategy for clinical reasoning, in students with problem-based learning tutorial experiences.

    Science.gov (United States)

    Okubo, Yumiko; Ishiguro, Naoko; Suganuma, Taiyo; Nishikawa, Toshio; Takubo, Toshio; Kojimahara, Noriko; Yago, Rie; Nunoda, Shinichi; Sugihara, Shigetaka; Yoshioka, Toshimasa

    2012-01-01

    Acquiring clinical reasoning skills in lectures may be difficult, but it can be learnt through problem-solving in the context of clinical practice. Problem finding and solving are skills required for clinical reasoning; however, students who underwent problem-based learning (PBL) still have difficulty in acquiring clinical reasoning skills. We hypothesized that team-based learning (TBL), a learning strategy that provides the opportunity to solve problems by repeatedly taking tests, can enhance the clinical reasoning ability in medical students with PBL experiences during the pre-clinical years. TBL courses were designed for 4(th) year students in a 6-year program in 2008, 2009, and 2010. TBL individual scores, consisting of a combination of individual and group tests, were compared with scores of several examinations including computer-based testing (CBT), an original examination assessing clinical reasoning ability (problem-solving ability test; P-SAT), term examinations, and Objective Structured Clinical Examination (OSCE). CBT, OSCE and P-SAT scores were compared with those of students who learned clinical reasoning only through PBL tutorials in 2005, 2006, and 2007 (non-TBL students). Individual TBL scores of students did not correlate with scores of any other examination. Assessments on clinical reasoning ability, such as CBT, OSCE, and P-SAT scores, were significantly higher in TBL students compared with non-TBL students. Students found TBL to be effective, particularly in areas of problem solving by both individuals and teams, and feedback from specialists. In conclusion, TBL for clinical reasoning is useful in improving clinical reasoning ability in students with PBL experiences with limited clinical exposure.

  6. Genome-based versus gene-based theory of cancer: Possible implications for clinical practice

    Indian Academy of Sciences (India)

    Nataša Todorović-Raković

    2011-09-01

    The current state in oncology research indicates that the attempts to explain such complex process as cancerogenesis by a single or several genetic mutations were not successful enough. On the other hand, chromosomal/genomic instability – almost universal features of malignant tumours which influence a global pattern of gene expression and, subsequently, many oncogenic pathways – were often disregarded and considered nonessential to clinical application. However, a new arising field of system biology including ‘new forms’ of genome diversity such as copy number variations (CNV) and high-throughput oncogene mutation profiling now reveal all the complexity of cancer and provide the final explanation of the oncogenic pathways, based on stochastic (onco)genomic variation rather than on (onco)genic concepts.

  7. [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.

  8. Clinical practice guidelines for evidence-based management of sedoanalgesia in critically ill adult patients.

    Science.gov (United States)

    Celis-Rodríguez, E; Birchenall, C; de la Cal, M Á; Castorena Arellano, G; Hernández, A; Ceraso, D; Díaz Cortés, J C; Dueñas Castell, C; Jimenez, E J; Meza, J C; Muñoz Martínez, T; Sosa García, J O; Pacheco Tovar, C; Pálizas, F; Pardo Oviedo, J M; Pinilla, D I; Raffán-Sanabria, F; Raimondi, N; Righy Shinotsuka, C; Suárez, M; Ugarte, S; Rubiano, S

    2013-11-01

    Optimal management of sedation, analgesia and delirium offers comfort and security for the critical care patient, allows support measures to be applied more easily and enables an integral approach of medical care, at the same time that lowers the incidence of complications, wich translates in better patient outcomes. To update the Guía de práctica clínica basada en la evidencia para el manejo de la sedoanalgesia en el paciente adulto críticamente enfermo published in Medicina Intensiva in 2007, and give recommendations for the management of sedation, analgesia, and delirium. A group of 21 intensivists from 9 countries of the Federación Panamericana e Ibérica de Sociedades de Medicina Crítica y Terapia Intensiva, 3 of them also specialists in clinical epidemiology and methodology, gathered for the development of guidelines. Assessment of evidence quality and recommendations were made based on the Grading of Recommendations Assessment, Development and Evaluation system. Strength of recommendations was classified as 1=strong, or 2=weak, and quality of evidence as A=high, B=moderate, or C=low. Two authors searched the following databases: MEDLINE through PUBMED, The Cochrane Library and Literatura Latinoamericana y del Caribe en Ciencias de la Salud and retrieved pertinent information. Members assigned to the 11 sections of the guidelines, based on the literature review, formulated the recommendations, that were discussed in plenary sessions. Only those recommendations that achieved more than 80% of consensus were approved for the final document. The Colombian Association of Critical Medicine and Intensive Care (AMCI) supported the elaboration of this guidelines. Four hundred sixty-seven articles were included for review. An increase in number and quality of publications was observed. This allowed to generate 64 strong recommendations with high and moderate quality of evidence in contrast to the 28 recommendations of the previous edition. This Guidelines

  9. Metadata registry and management system based on ISO 11179 for Cancer Clinical Trials Information System.

    Science.gov (United States)

    Park, Yu Rang; Kim, Ju Han

    2006-01-01

    Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers.

  10. Intraspecies transmission of BASE induces clinical dullness and amyotrophic changes.

    Science.gov (United States)

    Lombardi, Guerino; Casalone, Cristina; D' Angelo, Antonio; Gelmetti, Daniela; Torcoli, Gloria; Barbieri, Ilaria; Corona, Cristiano; Fasoli, Elisa; Farinazzo, Alessia; Fiorini, Michele; Gelati, Matteo; Iulini, Barbara; Tagliavini, Fabrizio; Ferrari, Sergio; Caramelli, Maria; Monaco, Salvatore; Capucci, Lorenzo; Zanusso, Gianluigi

    2008-05-23

    The disease phenotype of bovine spongiform encephalopathy (BSE) and the molecular/ biological properties of its prion strain, including the host range and the characteristics of BSE-related disorders, have been extensively studied since its discovery in 1986. In recent years, systematic testing of the brains of cattle coming to slaughter resulted in the identification of at least two atypical forms of BSE. These emerging disorders are characterized by novel conformers of the bovine pathological prion protein (PrP(TSE)), named high-type (BSE-H) and low-type (BSE-L). We recently reported two Italian atypical cases with a PrP(TSE) type identical to BSE-L, pathologically characterized by PrP amyloid plaques and known as bovine amyloidotic spongiform encephalopathy (BASE). Several lines of evidence suggest that BASE is highly virulent and easily transmissible to a wide host range. Experimental transmission to transgenic mice overexpressing bovine PrP (Tgbov XV) suggested that BASE is caused by a prion strain distinct from the BSE isolate. In the present study, we experimentally infected Friesian and Alpine brown cattle with Italian BSE and BASE isolates via the intracerebral route. BASE-infected cattle developed amyotrophic changes accompanied by mental dullness. The molecular and neuropathological profiles, including PrP deposition pattern, closely matched those observed in the original cases. This study provides clear evidence of BASE as a distinct prion isolate and discloses a novel disease phenotype in cattle.

  11. Intraspecies Transmission of BASE Induces Clinical Dullness and Amyotrophic Changes

    Science.gov (United States)

    Lombardi, Guerino; Casalone, Cristina; D' Angelo, Antonio; Gelmetti, Daniela; Torcoli, Gloria; Barbieri, Ilaria; Corona, Cristiano; Fasoli, Elisa; Farinazzo, Alessia; Fiorini, Michele; Gelati, Matteo; Iulini, Barbara; Tagliavini, Fabrizio; Ferrari, Sergio; Caramelli, Maria; Monaco, Salvatore; Capucci, Lorenzo; Zanusso, Gianluigi

    2008-01-01

    The disease phenotype of bovine spongiform encephalopathy (BSE) and the molecular/ biological properties of its prion strain, including the host range and the characteristics of BSE-related disorders, have been extensively studied since its discovery in 1986. In recent years, systematic testing of the brains of cattle coming to slaughter resulted in the identification of at least two atypical forms of BSE. These emerging disorders are characterized by novel conformers of the bovine pathological prion protein (PrPTSE), named high-type (BSE-H) and low-type (BSE-L). We recently reported two Italian atypical cases with a PrPTSE type identical to BSE-L, pathologically characterized by PrP amyloid plaques and known as bovine amyloidotic spongiform encephalopathy (BASE). Several lines of evidence suggest that BASE is highly virulent and easily transmissible to a wide host range. Experimental transmission to transgenic mice overexpressing bovine PrP (Tgbov XV) suggested that BASE is caused by a prion strain distinct from the BSE isolate. In the present study, we experimentally infected Friesian and Alpine brown cattle with Italian BSE and BASE isolates via the intracerebral route. BASE-infected cattle developed amyotrophic changes accompanied by mental dullness. The molecular and neuropathological profiles, including PrP deposition pattern, closely matched those observed in the original cases. This study provides clear evidence of BASE as a distinct prion isolate and discloses a novel disease phenotype in cattle. PMID:18497860

  12. Intraspecies transmission of BASE induces clinical dullness and amyotrophic changes.

    Directory of Open Access Journals (Sweden)

    Guerino Lombardi

    2008-05-01

    Full Text Available The disease phenotype of bovine spongiform encephalopathy (BSE and the molecular/ biological properties of its prion strain, including the host range and the characteristics of BSE-related disorders, have been extensively studied since its discovery in 1986. In recent years, systematic testing of the brains of cattle coming to slaughter resulted in the identification of at least two atypical forms of BSE. These emerging disorders are characterized by novel conformers of the bovine pathological prion protein (PrP(TSE, named high-type (BSE-H and low-type (BSE-L. We recently reported two Italian atypical cases with a PrP(TSE type identical to BSE-L, pathologically characterized by PrP amyloid plaques and known as bovine amyloidotic spongiform encephalopathy (BASE. Several lines of evidence suggest that BASE is highly virulent and easily transmissible to a wide host range. Experimental transmission to transgenic mice overexpressing bovine PrP (Tgbov XV suggested that BASE is caused by a prion strain distinct from the BSE isolate. In the present study, we experimentally infected Friesian and Alpine brown cattle with Italian BSE and BASE isolates via the intracerebral route. BASE-infected cattle developed amyotrophic changes accompanied by mental dullness. The molecular and neuropathological profiles, including PrP deposition pattern, closely matched those observed in the original cases. This study provides clear evidence of BASE as a distinct prion isolate and discloses a novel disease phenotype in cattle.

  13. Online survey system for image-based clinical guideline studies using the Delphi method.

    Science.gov (United States)

    Harper, Todd M; Teng, Chia-Chi

    2011-01-01

    The increasing use of health information technology (HIT) is due to a rising interest in improving the quality of health care. HIT has the potential to reduce cost and transform services. Proper clinical support systems will contribute to the meaningful use of HIT systems by providing a wide array of data to clinicians for the diagnosis and treatments. Clinical guidelines, created by a consensus of experts, can be put in place to assist physicians in making clinical decisions. Delphi methods are commonly used to create consensus from surveys completed by a team of experts. Image based studies could create guidelines that standardize severity, deformity or other clinical classifications. As these studies were traditionally conducted using paper based media, the cost and time requirement often make the process impractical. Ware proposing a web based system to aid medical researchers in conducting image based Delphi studies for improved clinical guidelines and decision support.

  14. Sustained effect of simulation-based ultrasound training on clinical performance

    DEFF Research Database (Denmark)

    Tolsgaard, M G; Ringsted, C; Dreisler, E

    2015-01-01

    on a virtual-reality transvaginal ultrasound simulator until an expert performance level was attained followed by training on a pelvic mannequin. After two months of clinical training, one transvaginal ultrasound scan was recorded for assessment of participants' clinical performance. Two blinded ultrasound......, new residents in OB-GYN (N = 33) without prior ultrasound experience were included from three teaching hospitals. Participants were allocated to simulation-based training and subsequent clinical training (n = 18) or only clinical training (n = 15). The simulation-based training was performed...

  15. Drugs Approved for Stomach (Gastric) Cancer

    Science.gov (United States)

    ... Ask about Your Treatment Research Drugs Approved for Stomach (Gastric) Cancer This page lists cancer drugs approved ... that are not listed here. Drugs Approved for Stomach (Gastric) Cancer Cyramza (Ramucirumab) Docetaxel Doxorubicin Hydrochloride 5- ...

  16. 42 CFR 84.50 - Types of respirators to be approved; scope of approval.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Types of respirators to be approved; scope of... Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time § 84.50 Types of respirators to be approved; scope of approval. Approvals shall be issued for the types of respirators...

  17. New EMA report on paliperidone 3-month injections: taking clinical and policy decisions without an adequate evidence base.

    Science.gov (United States)

    Ostuzzi, G; Papola, D; Gastaldon, C; Barbui, C

    2016-12-22

    Three-month long-acting paliperidone is a new, recently marketed, formulation of paliperidone, characterised by the longest available dosing interval among long-acting antipsychotics. The clinical profile of 3-month long-acting paliperidone was recently summarised by the European Medicines Agency (EMA) in a public assessment report, released in April 2016. In this commentary, the main strengths and limitations of the EMA assessment report were appraised and discussed, in order to highlight possible implications for clinical practice, future research and regulatory practices for drug approval.

  18. Orthopaedic Device Approval Through the Premarket Approval Process: A Financial Feasibility Analysis for a Single Center.

    Science.gov (United States)

    Yang, Brian W; Iorio, Matthew L; Day, Charles S

    2017-03-15

    The 2 main routes of medical device approval through the U.S. Food and Drug Administration are the premarket approval (PMA) process, which requires clinical trials, and the 510(k) premarket notification, which exempts devices from clinical trials if they are substantially equivalent to an existing device. Recently, there has been growing concern regarding the safety of devices approved through the 510(k) premarket notification. The PMA process decreases the potential for device recall; however, it is substantially more costly and time-consuming. Investors and medical device companies are only willing to invest in devices if they can expect to recoup their investment within a timeline of roughly 7 years. Our study utilizes financial modeling to assess the financial feasibility of approving various orthopaedic medical devices through the 510(k) and PMA processes. The expected time to recoup investment through the 510(k) process ranged from 0.585 years to 7.715 years, with an average time of 2.4 years; the expected time to recoup investment through the PMA route ranged from 2.9 years to 24.5 years, with an average time of 8.5 years. Six of the 13 orthopaedic device systems that we analyzed would require longer than our 7-year benchmark to recoup the investment costs of the PMA process. With the 510(k) premarket notification, only 1 device system would take longer than 7 years to recoup its investment costs. Although the 510(k) premarket notification has demonstrated safety concerns, broad requirements for PMA authorization may limit device innovation for less-prevalent orthopaedic conditions. As a result, new approval frameworks may be beneficial. Our report demonstrates how current regulatory policies can potentially influence orthopaedic device innovation.

  19. Surface Plasmon Resonance for Cell-Based Clinical Diagnosis

    Directory of Open Access Journals (Sweden)

    Yuhki Yanase

    2014-03-01

    Full Text Available Non-invasive real-time observations and the evaluation of living cell conditions and functions are increasingly demanded in life sciences. Surface plasmon resonance (SPR sensors detect the refractive index (RI changes on the surface of sensor chips in label-free and on a real-time basis. Using SPR sensors, we and other groups have developed techniques to evaluate living cells’ reactions in response to stimuli without any labeling in a real-time manner. The SPR imaging (SPRI system for living cells may visualize single cell reactions and has the potential to expand application of SPR cell sensing for clinical diagnosis, such as multi-array cell diagnostic systems and detection of malignant cells among normal cells in combination with rapid cell isolation techniques.

  20. ATTITUDE AND PERCEPTION OF FACULTIES TOWARDS TEACHING EVIDENCE BASED MEDICINE TO PRE - CLINICAL & PARA - CLINICAL MEDICAL STUDENTS

    Directory of Open Access Journals (Sweden)

    Bhavita Patel

    2015-02-01

    Full Text Available NTRODUCTION: Evidence - based medicine (EBM is defined as the „conscientious, explicit, and judicious use of current best evidence‟. It i s an important tool for lifelong learning in medicine, and medical students can develop the skills necessary to understand and use EBM. The teaching of EBM in Sumandeep Vidyapeeth is as part of Evidence Based Education System (EBES. The university has imp lemented the 16 hours of teaching with project work on Evidence Based Medicine in 1st MBBS and 2nd MBBS curriculum in addition to MBBS syllabus. AIMS & OBJECTIVES: This study was planned to take feedback from all the faculties those who are involved in Evi dence based Medicine teaching to evaluate their attitude and perception towards this innovative teaching method and to recommend improvements. MATERIAL & METHODS: A Descriptive, self - structured , pilot pretested questionnaire based cross sectional study was conducted in the year 2013 - 2014 among 40 faculties from 7 Departments like Anatomy, Physiology, Biochemistry, Microbiology, Pharmacology, Pathology and Forensic Medicine teaching Evidence Base d Medicine to students at S.B.K.S MI & RC, Sumandeep Vidyapeeth. Data was expressed as percentage. RESULTS: The response rate for the study was 75%. Almost 87% of faculties agreed that teaching EBM is a welcoming development during pre and para clinical ye ars. About 80% faculties agreed that it will help them in future clinical learning. 87% faculties agreed that literature and research searching improves their day to day teaching. About 77% of faculties have attended workshop and training held in Universit y and 83% of faculties agreed that they are interested in more learning and improving skills necessary to incorporate Evidence based medicine into their discipline. Barriers included shortage of time and need for training in teaching EBM. CONCLUSION: Facul ties of this University teaching Pre - clinical and Para - clinical medical students recognized

  1. Approval plans issues and innovations

    CERN Document Server

    Katz, Linda S

    2013-01-01

    How can you, as an acquisition librarians, keep current on the output of hundreds of publishers? The answer, of course, is that you cannot. For over 30 years, approval plans have been used by librarians to acquire current titles, save staff time, and build core collections. Even today, these reasons seem appropriate, as libraries try to maintain up-to-date collections and control personnel and operating budgets. However, as shown in Approval Plans: Issues and Innovations, the use of approval plans is not so simple and straightforward; their use is subject to complex procedures and policies--an

  2. The status of platinum anticancer drugs in the clinic and in clinical trials.

    Science.gov (United States)

    Wheate, Nial J; Walker, Shonagh; Craig, Gemma E; Oun, Rabbab

    2010-09-21

    Since its approval in 1979 cisplatin has become an important component in chemotherapy regimes for the treatment of ovarian, testicular, lung and bladder cancers, as well as lymphomas, myelomas and melanoma. Unfortunately its continued use is greatly limited by severe dose limiting side effects and intrinsic or acquired drug resistance. Over the last 30 years, 23 other platinum-based drugs have entered clinical trials with only two (carboplatin and oxaliplatin) of these gaining international marketing approval, and another three (nedaplatin, lobaplatin and heptaplatin) gaining approval in individual nations. During this time there have been more failures than successes with the development of 14 drugs being halted during clinical trials. Currently there are four drugs in the various phases of clinical trial (satraplatin, picoplatin, Lipoplatin and ProLindac). No new small molecule platinum drug has entered clinical trials since 1999 which is representative of a shift in focus away from drug design and towards drug delivery in the last decade. In this perspective article we update the status of platinum anticancer drugs currently approved for use, those undergoing clinical trials and those discontinued during clinical trials, and discuss the results in the context of where we believe the field will develop over the next decade.

  3. Towards evidence-based clinical practice: an international survey of 18 clinical guideline programs.

    NARCIS (Netherlands)

    Burgers, J.S.; Grol, R.P.T.M.; Klazinga, N.S.; Makela, M.; Zaat, J.O.M.

    2003-01-01

    OBJECTIVE: To describe systematically the structures and working methods of guideline programs. DESIGN: Descriptive survey using a questionnaire with 32 items based on a framework derived from the literature. Answers were tabulated and checked by participants. STUDY PARTICIPANTS: Key informants of 1

  4. A work-based learning approach for clinical support workers on mental health inpatient wards.

    Science.gov (United States)

    Kemp, Philip; Gilding, Moorene; Seewooruttun, Khooseal; Walsh, Hannah

    2016-09-14

    Background With a rise in the number of unqualified staff providing health and social care, and reports raising concerns about the quality of care provided, there is a need to address the learning needs of clinical support workers. This article describes a qualitative evaluation of a service improvement project that involved a work-based learning approach for clinical support workers on mental health inpatient wards. Aim To investigate and identify insights in relation to the content and process of learning using a work-based learning approach for clinical support workers. Method This was a qualitative evaluation of a service improvement project involving 25 clinical support workers at the seven mental health inpatient units in South London and Maudsley NHS Foundation Trust. Three clinical skills tutors were appointed to develop, implement and evaluate the work-based learning approach. Four sources of data were used to evaluate this approach, including reflective journals, qualitative responses to questionnaires, three focus groups involving the clinical support workers and a group interview involving the clinical skills tutors. Data were analysed using thematic analysis. Findings The work-based learning approach was highly valued by the clinical support workers and enhanced learning in practice. Face-to-face learning in practice helped the clinical support workers to develop practice skills and reflective learning skills. Insights relating to the role of clinical support workers were also identified, including the benefits of face-to-face supervision in practice, particularly in relation to the interpersonal aspects of care. Conclusion A work-based learning approach has the potential to enhance care delivery by meeting the learning needs of clinical support workers and enabling them to apply learning to practice. Care providers should consider how the work-based learning approach can be used on a systematic, organisation-wide basis in the context of budgetary

  5. Pan-pathway based interaction profiling of FDA-approved nucleoside and nucleobase analogs with enzymes of the human nucleotide metabolism.

    Directory of Open Access Journals (Sweden)

    Louise Egeblad

    Full Text Available To identify interactions a nucleoside analog library (NAL consisting of 45 FDA-approved nucleoside analogs was screened against 23 enzymes of the human nucleotide metabolism using a thermal shift assay. The method was validated with deoxycytidine kinase; eight interactions known from the literature were detected and five additional interactions were revealed after the addition of ATP, the second substrate. The NAL screening gave relatively few significant hits, supporting a low rate of "off target effects." However, unexpected ligands were identified for two catabolic enzymes guanine deaminase (GDA and uridine phosphorylase 1 (UPP1. An acyclic guanosine prodrug analog, valaciclovir, was shown to stabilize GDA to the same degree as the natural substrate, guanine, with a ΔT(agg around 7°C. Aciclovir, penciclovir, ganciclovir, thioguanine and mercaptopurine were also identified as ligands for GDA. The crystal structure of GDA with valaciclovir bound in the active site was determined, revealing the binding of the long unbranched chain of valaciclovir in the active site of the enzyme. Several ligands were identified for UPP1: vidarabine, an antiviral nucleoside analog, as well as trifluridine, idoxuridine, floxuridine, zidovudine, telbivudine, fluorouracil and thioguanine caused concentration-dependent stabilization of UPP1. A kinetic study of UPP1 with vidarabine revealed that vidarabine was a mixed-type competitive inhibitor with the natural substrate uridine. The unexpected ligands identified for UPP1 and GDA imply further metabolic consequences for these nucleoside analogs, which could also serve as a starting point for future drug design.

  6. From Paper Based Clinical Practice Guidelines to Declarative Workflow Management

    DEFF Research Database (Denmark)

    Lyng, Karen Marie; Hildebrandt, Thomas; Mukkamala, Raghava Rao

    2009-01-01

    a sub workflow can be described in a declarative workflow management system: the Resultmaker Online Consultant (ROC). The example demonstrates that declarative primitives allow to naturally extend the paper based flowchart to an executable model without introducing a complex cyclic control flow graph....

  7. Expert Systems Based Clinical Assessment and Tutorial Project.

    Science.gov (United States)

    Papa, Frank; Shores, Jay

    This project at the Texas College of Osteopathic Medicine (Fort Worth) evaluated the use of an artificial-intelligence-derived measure, "Knowledge-Based Inference Tool" (KBIT), as the basis for assessing medical students' diagnostic capabilities and designing instruction to improve diagnostic skills. The instrument was designed to…

  8. Validation of evidence-based clinical practice guideline: Nursing ...

    African Journals Online (AJOL)

    Amel Ibrahim Ahmed

    2012-01-31

    Jan 31, 2012 ... Introduction ... 5% of treatment outcome of new smear positive cases.7 Treat- ... well as, to operate the implementation of evidence-based prac- ... (nurses) and the end point beneficiaries (newly diagnosed pa- ..... through sputum test. Also ..... national Standards for tuberculosis care: Diagnosis, Treatment.

  9. Evidence-based diagnosis and clinical decision making

    NARCIS (Netherlands)

    Mileman, P.A.; van den Hout, W.B.

    2009-01-01

    The application of evidence-based dentistry to diagnosis should result in a reduction of errors in decision making. The frequency of errors is dependent not only on the accuracy of a diagnostic test for pathology, but also on the prior chance of disease being present. If this chance is low and below

  10. From Paper Based Clinical Practice Guidelines to Declarative Workflow Management

    DEFF Research Database (Denmark)

    Lyng, Karen Marie; Hildebrandt, Thomas; Mukkamala, Raghava Rao

    2009-01-01

    a sub workflow can be described in a declarative workflow management system: the Resultmaker Online Consultant (ROC). The example demonstrates that declarative primitives allow to naturally extend the paper based flowchart to an executable model without introducing a complex cyclic control flow graph....

  11. Web-based unfolding cases: a strategy to enhance and evaluate clinical reasoning skills.

    Science.gov (United States)

    Johnson, Gail; Flagler, Susan

    2013-10-01

    Clinical reasoning involves the use of both analytical and nonanalytical intuitive cognitive processes. Fostering student development of clinical reasoning skills and evaluating student performance in this cognitive arena can challenge educators. The use of Web-based unfolding cases is proposed as a strategy to address these challenges. Unfolding cases mimic real-life clinical situations by presenting only partial clinical information in sequential segments. Students receive immediate feedback after submitting a response to a given segment. The student's comparison of the desired and submitted responses provides information to enhance the development of clinical reasoning skills. Each student's set of case responses are saved for the instructor in an individual-student electronic file, providing a record of the student's knowledge and thinking processes for faculty evaluation. For the example case given, the approaches used to evaluate individual components of clinical reasoning are provided. Possible future uses of Web-based unfolding cases are described. Copyright 2013, SLACK Incorporated.

  12. Mobile phone based clinical microscopy for global health applications.

    Directory of Open Access Journals (Sweden)

    David N Breslauer

    Full Text Available Light microscopy provides a simple, cost-effective, and vital method for the diagnosis and screening of hematologic and infectious diseases. In many regions of the world, however, the required equipment is either unavailable or insufficiently portable, and operators may not possess adequate training to make full use of the images obtained. Counterintuitively, these same regions are often well served by mobile phone networks, suggesting the possibility of leveraging portable, camera-enabled mobile phones for diagnostic imaging and telemedicine. Toward this end we have built a mobile phone-mounted light microscope and demonstrated its potential for clinical use by imaging P. falciparum-infected and sickle red blood cells in brightfield and M. tuberculosis-infected sputum samples in fluorescence with LED excitation. In all cases resolution exceeded that necessary to detect blood cell and microorganism morphology, and with the tuberculosis samples we took further advantage of the digitized images to demonstrate automated bacillus counting via image analysis software. We expect such a telemedicine system for global healthcare via mobile phone -- offering inexpensive brightfield and fluorescence microscopy integrated with automated image analysis -- to provide an important tool for disease diagnosis and screening, particularly in the developing world and rural areas where laboratory facilities are scarce but mobile phone infrastructure is extensive.

  13. Ontology-based data integration between clinical and research systems.

    Directory of Open Access Journals (Sweden)

    Sebastian Mate

    Full Text Available Data from the electronic medical record comprise numerous structured but uncoded elements, which are not linked to standard terminologies. Reuse of such data for secondary research purposes has gained in importance recently. However, the identification of relevant data elements and the creation of database jobs for extraction, transformation and loading (ETL are challenging: With current methods such as data warehousing, it is not feasible to efficiently maintain and reuse semantically complex data extraction and trans-formation routines. We present an ontology-supported approach to overcome this challenge by making use of abstraction: Instead of defining ETL procedures at the database level, we use ontologies to organize and describe the medical concepts of both the source system and the target system. Instead of using unique, specifically developed SQL statements or ETL jobs, we define declarative transformation rules within ontologies and illustrate how these constructs can then be used to automatically generate SQL code to perform the desired ETL procedures. This demonstrates how a suitable level of abstraction may not only aid the interpretation of clinical data, but can also foster the reutilization of methods for un-locking it.

  14. Integration of evidence based medicine into the clinical years of a medical curriculum

    Directory of Open Access Journals (Sweden)

    Mazen Ferwana

    2012-01-01

    Full Text Available Teaching Evidence Based Medicine (EBM helps medical students to develop their decision making skills based on current best evidence, especially when it is taught in a clinical context. Few medical schools integrate Evidence Based Medicine into undergraduate curriculum, and those who do so, do it at the academic years only as a standalone (classroom teaching but not at the clinical years. The College of Medicine at King Saud bin Abdulaziz University for Health Sciences was established in January 2004. The college adopted a four-year Problem Based Learning web-based curriculum. The objective of this paper is to present our experience in the integration of the EBM in the clinical phase of the medical curriculum. We teach EBM in 3 steps: first step is teaching EBM concepts and principles, second is teaching the appraisal and search skills, and the last step is teaching it in clinical rotations. Teaching EBM at clinical years consists of 4 student-centered tutorials. In conclusion, EBM may be taught in a systematic, patient centered approach at clinical rounds. This paper could serve as a model of Evidence Based Medicine integration into the clinical phase of a medical curriculum.

  15. Evidence Base of Clinical Studies on Tai Chi: A Bibliometric Analysis

    OpenAIRE

    Guo-Yan Yang; Li-Qiong Wang; Jun Ren; Yan Zhang; Meng-Ling Li; Yu-Ting Zhu; Jing Luo; Yan-Jun Cheng; Wen-Yuan Li; Peter M. Wayne; Jian-Ping Liu

    2015-01-01

    BACKGROUND: The safety and health benefits of Tai Chi mind-body exercise has been documented in a large number of clinical studies focused on specific diseases and health conditions. The objective of this systematic review is to more comprehensively summarize the evidence base of clinical studies of Tai Chi for healthcare. METHODS AND FINDINGS: We searched for all types of clinical studies on Tai chi in PubMed, the Cochrane Library and four major Chinese electronic databases from their incept...

  16. Technology-based strategies for promoting clinical reasoning skills in nursing education.

    Science.gov (United States)

    Shellenbarger, Teresa; Robb, Meigan

    2015-01-01

    Faculty face the demand of preparing nursing students for the constantly changing health care environment. Effective use of online, classroom, and clinical conferencing opportunities helps to enhance nursing students' clinical reasoning capabilities needed for practice. The growth of technology creates an avenue for faculty to develop engaging learning opportunities. This article presents technology-based strategies such as electronic concept mapping, electronic case histories, and digital storytelling that can be used to facilitate clinical reasoning skills.

  17. A Semantic Web-based System for Mining Genetic Mutations in Cancer Clinical Trials.

    Science.gov (United States)

    Priya, Sambhawa; Jiang, Guoqian; Dasari, Surendra; Zimmermann, Michael T; Wang, Chen; Heflin, Jeff; Chute, Christopher G

    2015-01-01

    Textual eligibility criteria in clinical trial protocols contain important information about potential clinically relevant pharmacogenomic events. Manual curation for harvesting this evidence is intractable as it is error prone and time consuming. In this paper, we develop and evaluate a Semantic Web-based system that captures and manages mutation evidences and related contextual information from cancer clinical trials. The system has 2 main components: an NLP-based annotator and a Semantic Web ontology-based annotation manager. We evaluated the performance of the annotator in terms of precision and recall. We demonstrated the usefulness of the system by conducting case studies in retrieving relevant clinical trials using a collection of mutations identified from TCGA Leukemia patients and Atlas of Genetics and Cytogenetics in Oncology and Haematology. In conclusion, our system using Semantic Web technologies provides an effective framework for extraction, annotation, standardization and management of genetic mutations in cancer clinical trials.

  18. [Asymptomatic skull base metastases: clinical course and therapeutic alternatives].

    Science.gov (United States)

    Vargas, A; Paulazo, C; Oleaga, L; Verger, E

    2017-03-01

    Introduccion. Las metastasis sintomaticas de la base craneal (MBC) son una progresion infrecuente, tardia y de mal pronostico en pacientes con tumores solidos. Sus manifestaciones clinicas pueden agruparse en cinco sindromes caracteristicos, y su tratamiento mas frecuente es la radioterapia. Gracias a los progresos tecnologicos en las pruebas de imagen y al seguimiento estrecho de los pacientes con cancer, las MBC pueden diagnosticarse incidentalmente. En este subgrupo no se conoce la evolucion clinica ni se ha establecido la mejor modalidad de tratamiento. Objetivo. Analizar las caracteristicas clinicas y la evolucion de los pacientes diagnosticados incidentalmente de MBC. Pacientes y metodos. Entre enero de 2012 y diciembre de 2015, 31 pacientes con una neoplasia solida diagnosticados de MBC fueron valorados por nuestro servicio. Resultados. Las MBC se diagnosticaron por la presencia de un sindrome de base craneal (n = 24) o incidentalmente (n = 7). Los pacientes sintomaticos fueron tratados con radioterapia. Todos los pacientes diagnosticados incidentalmente permanecieron sin sintomas relacionados con la afectacion de la base craneal hasta la fecha del fallecimiento, aunque frecuentemente presentaron de forma concomitante otros tipos de progresion intracraneal de mal pronostico. Se observo una diferencia estadisticamente significativa en la supervivencia a favor de los pacientes sintomaticos (p = 0,001). Conclusiones. Las MBC diagnosticadas incidentalmente se asociaron frecuentemente a otros tipos de progresion intracraneal, limitando las opciones terapeuticas.

  19. Electronic Voucher Approval - Financial Management

    Data.gov (United States)

    US Agency for International Development — This process provides a workflow and eSignature capability which allows the CFO to router vouchers for review and electronic signature approval to COTRs in AIDW. It...

  20. Mavyret Approved for Hepatitis C

    Science.gov (United States)

    ... news/fullstory_167618.html Mavyret Approved for Hepatitis C A chronic viral infection of the liver To ... treat adults with certain types of chronic hepatitis C virus (HCV). The combination drug is the first ...

  1. Drugs Approved for Wilms Tumor

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Wilms tumor and other childhood kidney cancers. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  2. Elosulfase alfa: first global approval.

    Science.gov (United States)

    Sanford, Mark; Lo, Jin Han

    2014-04-01

    Elosulfase alfa (Vimizim™) is a recombinant form of N-acetylgalactosamine-6-sulfatase (GALNS) that was developed by BioMarin Pharmaceutical Inc. as an enzyme replacement therapy for patients with mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio A syndrome. Patients with MPS IVA have a GALNS deficiency, which results in serious musculoskeletal, cardiorespiratory and other system disturbances. Elosulfase alfa was approved by the US FDA on 14 February 2014 for the treatment of MPS IVA. The European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has recently recommended that elosulfase alfa be approved for use in the EU in the same indication. Within the last year, the manufacturer has also filed applications for approval for the use of elosulfase alfa in MPS IVA in Brazil, Australia, Canada and Mexico. This article summarizes the milestones in the development of elosulfase alfa leading to its first global approval in MPS IVA.

  3. Is It Really FDA Approved?

    Science.gov (United States)

    ... must be proven safe and effective to FDA’s satisfaction before companies can market them in interstate commerce. ... product to market. back to top FDA approves food additives in food for people. Although FDA does ...

  4. Drugs Approved for Liver Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for liver cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  5. Drugs Approved for Vulvar Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for vulvar cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  6. Drugs Approved for Esophageal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for esophageal cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  7. Drugs Approved for Vaginal Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) to prevent vaginal cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  8. Drugs Approved for Endometrial Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for endometrial cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  9. Drugs Approved for Penile Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for penile cancer. The list includes generic names and brand names. The drug names link to NCI’s Cancer Drug Information summaries.

  10. Drugs Approved for Bladder Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bladder cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  11. Drugs Approved for Breast Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for breast cancer. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters.

  12. Drugs Approved for Kaposi Sarcoma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for Kaposi sarcoma. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  13. Drugs Approved for Bone Cancer

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for bone cancer. The list includes generic names and brand names. The drug names link to NCI's Cancer Drug Information summaries.

  14. Drugs Approved for Prostate Cancer

    Science.gov (United States)

    ... 2015 2014 2013 2012 Media Resources Media Contacts Multicultural ... This page lists cancer drugs approved by the Food and Drug Administration (FDA) for prostate cancer. The list includes generic ...

  15. Trulance Approved for Chronic Constipation

    Science.gov (United States)

    ... news/fullstory_163171.html Trulance Approved for Chronic Constipation Drug designed to stimulate upper gastrointestinal tract To ... U.S. Food and Drug Administration to treat persistent constipation of unknown (idiopathic) cause in adults. Some 42 ...

  16. Rucaparib: the past, present, and future of a newly approved PARP inhibitor for ovarian cancer

    Directory of Open Access Journals (Sweden)

    Dockery LE

    2017-06-01

    Full Text Available LE Dockery, CC Gunderson, KN Moore Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA Abstract: Rucaparib camsylate (CO-338, AG-014699, PF-01367338 is a potent PARP-1, PARP-2, and PARP-3 inhibitor. Phase I and II studies demonstrated clinical efficacy in both BRCA-mutated (inclusive of germline and somatic ovarian tumors and ovarian tumors with homologous recombination deficiency (HRD loss of heterozygosity (LOH. Rucaparib has received the US Food and Drug Administration (FDA approval for patients with deleterious BRCA mutation (germline and/or somatic-associated advanced ovarian cancer who have been treated with two or more chemotherapies. There is evidence to suggest that rucaparib has clinical efficacy against ovarian tumors with high HRD-LOH. Rucaparib’s companion diagnostic FoundationFocus™ CDxBRCA test is the first FDA-approved next-generation sequencing-based companion diagnostic test designed to identify patients likely to respond to rucaparib. This article reviews the mechanisms of action, safety, approval, and indications for use of the PARP inhibitor rucaparib as well as future trials and use of rucaparib’s companion diagnostic test. Keywords: rucaparib, PARP inhibitor, ovarian cancer, companion diagnostic, loss of heterozy­gosity

  17. Rucaparib: the past, present, and future of a newly approved PARP inhibitor for ovarian cancer.

    Science.gov (United States)

    Dockery, L E; Gunderson, C C; Moore, K N

    2017-01-01

    Rucaparib camsylate (CO-338, AG-014699, PF-01367338) is a potent PARP-1, PARP-2, and PARP-3 inhibitor. Phase I and II studies demonstrated clinical efficacy in both BRCA-mutated (inclusive of germline and somatic) ovarian tumors and ovarian tumors with homologous recombination deficiency (HRD) loss of heterozygosity (LOH). Rucaparib has received the US Food and Drug Administration (FDA) approval for patients with deleterious BRCA mutation (germline and/or somatic)-associated advanced ovarian cancer who have been treated with two or more chemotherapies. There is evidence to suggest that rucaparib has clinical efficacy against ovarian tumors with high HRD-LOH. Rucaparib's companion diagnostic FoundationFocus™ CDx BRCA test is the first FDA-approved next-generation sequencing-based companion diagnostic test designed to identify patients likely to respond to rucaparib. This article reviews the mechanisms of action, safety, approval, and indications for use of the PARP inhibitor rucaparib as well as future trials and use of rucaparib's companion diagnostic test.

  18. Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

    Science.gov (United States)

    Leeper, Nicholas J; Bauer-Mehren, Anna; Iyer, Srinivasan V; Lependu, Paea; Olson, Cliff; Shah, Nigam H

    2013-01-01

    Peripheral arterial disease (PAD) is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF). We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55]), myocardial infarction (OR = 1.00, CI [0.71, 1.39]), or death (OR = 0.86, CI [0.63, 1.18]). Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

  19. Rucaparib Approved for Ovarian Cancer.

    Science.gov (United States)

    2017-02-01

    The FDA approved the PARP inhibitor rucaparib to treat women with advanced ovarian cancer who have already been treated with at least two chemotherapies and have a BRCA1 or BRCA2 gene mutation identified by an approved companion diagnostic test. The agency also gave a nod to the FoundationFocus CDxBRCA test to detect BRCA alterations. ©2017 American Association for Cancer Research.

  20. Students' Experiences of Clinic-Based Learning during a Final Year Veterinary Internship Programme

    Science.gov (United States)

    Matthew, Susan M.; Taylor, Rosanne M.; Ellis, Robert A.

    2010-01-01

    This study investigated veterinary students' experiences of clinic-based learning (CBL) during a comprehensive final year internship programme. Open-ended surveys (n = 93) were used to gather qualitative data about students' conceptions of what is learned during CBL and their approaches to learning in clinics. Phenomenography was used for detailed…

  1. Computer-Based versus High-Fidelity Mannequin Simulation in Developing Clinical Judgment in Nursing Education

    Science.gov (United States)

    Howard, Beverly J.

    2013-01-01

    The purpose of this study was to determine if students learn clinical judgment as effectively using computer-based simulations as when using high-fidelity mannequin simulations. There was a single research questions for this study: What is the difference in clinical judgment between participants completing high-fidelity human simulator mannequin…

  2. The Potential for Problem-Based Learning in Pharmacy Education: A Clinical Therapeutics Course in Diabetes.

    Science.gov (United States)

    Fisher, Richard C.

    1994-01-01

    A proposed problem-based course in clinical diabetes therapy at a pharmacy school is outlined. The interdisciplinary course requires students to develop or reformulate declarative and procedural knowledge in such a way that students' cognitive strategies are enhanced. Several sample clinical cases are appended. (MSE)

  3. Effects of an Art-Based Curriculum on Clinical Trials Attitudes and Breast Cancer Prevention Knowledge

    Science.gov (United States)

    Herman, Patricia M.; Larkey, Linda K.

    2006-01-01

    Although Latinos now comprise the largest minority in the U.S. population, they continue to be seriously underrepresented in clinical trials. A nonrandomized controlled study of an innovative community-developed clinical trial and breast cancer education program targeting Latinas tested whether use of an art-based curriculum could increase…

  4. Students' Experiences of Clinic-Based Learning during a Final Year Veterinary Internship Programme

    Science.gov (United States)

    Matthew, Susan M.; Taylor, Rosanne M.; Ellis, Robert A.

    2010-01-01

    This study investigated veterinary students' experiences of clinic-based learning (CBL) during a comprehensive final year internship programme. Open-ended surveys (n = 93) were used to gather qualitative data about students' conceptions of what is learned during CBL and their approaches to learning in clinics. Phenomenography was used for detailed…

  5. Population-Based Pediatric Reference Intervals in General Clinical Chemistry: A Swedish Survey.

    Science.gov (United States)

    Ridefelt, Peter

    2015-01-01

    Very few high quality studies on pediatric reference intervals for general clinical chemistry and hematology analytes have been performed. Three recent prospective community-based projects utilising blood samples from healthy children in Sweden, Denmark and Canada have substantially improved the situation. The Swedish survey included 701 healthy children. Reference intervals for general clinical chemistry and hematology were defined.

  6. Change in stated clinical practice associated with participation in the Dental Practice-Based Research Network

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Richman, Joshua S; Qvist, Vibeke

    2010-01-01

    Clinical researchers have attempted many methods to translate scientific evidence into routine clinical practice, with varying success. Practice-based research networks (PBRNs) provide an important, practitioner-friendly venue to test these methods. Dentist practitioner-investigators from the Den...

  7. Guidance for researchers developing and conducting clinical trials in practice-based research networks (PBRNs).

    Science.gov (United States)

    Dolor, Rowena J; Schmit, Kristine M; Graham, Deborah G; Fox, Chester H; Baldwin, Laura Mae

    2014-01-01

    There is increased interest nationally in multicenter clinical trials to answer questions about clinical effectiveness, comparative effectiveness, and safety in real-world community settings. Primary care practice-based research networks (PBRNs), comprising community- and/or academically affiliated practices committed to improving medical care for a range of health problems, offer ideal settings for these trials, especially pragmatic clinical trials. However, many researchers are not familiar with working with PBRNs. Experts in practice-based research identified solutions to challenges that researchers and PBRN personnel experience when collaborating on clinical trials in PBRNs. These were organized as frequently asked questions in a draft document presented at a 2013 Agency for Health care Research and Quality PBRN conference workshop, revised based on participant feedback, then shared with additional experts from the DARTNet Institute, Clinical Translational Science Award PBRN, and North American Primary Care Research Group PBRN workgroups for further input and modification. The "Toolkit for Developing and Conducting Multi-site Clinical Trials in Practice-Based Research Networks" offers guidance in the areas of recruiting and engaging practices, budgeting, project management, and communication, as well as templates and examples of tools important in developing and conducting clinical trials. Ensuring the successful development and conduct of clinical trials in PBRNs requires a highly collaborative approach between academic research and PBRN teams. © Copyright 2014 by the American Board of Family Medicine.

  8. Clinical and Research Perspectives on Nonspeech Oral Motor Treatments and Evidence-Based Practice

    Science.gov (United States)

    Muttiah, Nimisha; Georges, Katie; Brackenbury, Tim

    2011-01-01

    Purpose: Evidence-based practice (EBP) involves the incorporation of research evidence, clinical expertise, and client values in clinical decision making. One case in which these factors conflict is the use of nonspeech oral motor treatments (NSOMTs) for children with developmental speech sound disorders. Critical reviews of the research evidence…

  9. Role Model Ambulatory Care Clinical Training Site in a Community-Based Pharmacy.

    Science.gov (United States)

    Magarian, Edward O.; And Others

    1993-01-01

    An interdisciplinary project provided ambulatory care clinical training for pharmacy and nursing students in community-based pharmacies, promoting early detection and medical follow-up of common health problems within the community. Students learned new clinical skills in patient health assessment, new diagnostic technologies, patient education…

  10. A Population-Based Clinical Trial of Irinotecan and Carboplatin

    Directory of Open Access Journals (Sweden)

    Derick Lau

    2009-01-01

    Full Text Available Purpose. Phase I trials of anticancer drugs are commonly conducted using the method of modified Fibonacci. We have developed a population-based design for phase I trials of combining anticancer drugs such as irinotecan and carboplatin. Patients and Methods. Intrapatient dose escalation of irinotecan and carboplatin was performed according to a predetermined schema to reach individual dose-limiting toxicity (DLT in 50 patients with solid tumors refractory to previous chemotherapy. The individual toxicity-limiting dose levels were analyzed for normal distribution using the method of Ryan-Joiner and subsequently used to determine a population-based maximum tolerated dose (pMTD. For comparison, a simulation study was performed using the method of modified Fibonacci. Results. The most common dose-limiting toxicities (DLTs included neutropenia (58%, thrombocytopenia (16%, and diarrhea (8%. The frequency of individual toxicity-limiting dose levels of 50 patients approximated a normal distribution. The dose levels associated with individual limiting toxicities ranged from level 1 (irinotecan 100 mg/m2 and carboplatin AUC = 4 mg/mL x min to level 8 (irinotecan 350 mg/m2 and carboplatin AUC = 6. The pMTD was determined to be dose level 3 (150 mg/m2 for irinotecan and AUC = 5 for carboplatin. In contrast, the MTD was determined to be dose level 4 (200 mg/m2 for irinotecan and AUC 5 for carboplatin by modified-Fibonacci simulation. Conclusions. The population-based design of phase I trial allows optimization of dose intensity and derivation of a pMTD. The pMTD has been applied in phase II trial of irinotecan and carboplatin in patients with small-cell lung cancer.

  11. Competency-based assessment for clinical supervisors: design-based research on a web-delivered program.

    Science.gov (United States)

    Bacon, Rachel; Williams, Lauren Therese; Grealish, Laurie; Jamieson, Maggie

    2015-02-27

    Clinicians need to be supported by universities to use credible and defensible assessment practices during student placements. Web-based delivery of clinical education in student assessment offers professional development regardless of the geographical location of placement sites. This paper explores the potential for a video-based constructivist Web-based program to support site supervisors in their assessments of student dietitians during clinical placements. This project was undertaken as design-based research in two stages. Stage 1 describes the research consultation, development of the prototype, and formative feedback. In Stage 2, the program was pilot-tested and evaluated by a purposeful sample of nine clinical supervisors. Data generated as a result of user participation during the pilot test is reported. Users' experiences with the program were also explored via interviews (six in a focus group and three individually). The interviews were transcribed verbatim and thematic analysis conducted from a pedagogical perspective using van Manen's highlighting approach. This research succeeded in developing a Web-based program, "Feed our Future", that increased supervisors' confidence with their competency-based assessments of students on clinical placements. Three pedagogical themes emerged: constructivist design supports transformative Web-based learning; videos make abstract concepts tangible; and accessibility, usability, and pedagogy are interdependent. Web-based programs, such as Feed our Future, offer a viable means for universities to support clinical supervisors in their assessment practices during clinical placements. A design-based research approach offers a practical process for such Web-based tool development, highlighting pedagogical barriers for planning purposes.

  12. Approach to acid-base disorders – a clinical chemistry perspective

    African Journals Online (AJOL)

    Acid-base disorders are frequently encountered in clinical practice and have a significant impact on patient morbidity ... The first step in assessment of the arterial blood gas profile is .... amino acids in hyperalimentation are metabolised to HCl ...

  13. Developing computational model-based diagnostics to analyse clinical chemistry data

    NARCIS (Netherlands)

    Schalkwijk, D.B. van; Bochove, K. van; Ommen, B. van; Freidig, A.P.; Someren, E.P. van; Greef, J. van der; Graaf, A.A. de

    2010-01-01

    This article provides methodological and technical considerations to researchers starting to develop computational model-based diagnostics using clinical chemistry data.These models are of increasing importance, since novel metabolomics and proteomics measuring technologies are able to produce large

  14. Effects of conventional and problem-based learning on clinical and general competencies and career development

    NARCIS (Netherlands)

    Cohen-Schotanus, Janke; Muijtjens, Arno M. M.; Schonrock-Adema, Johanna; Geertsma, Jelle; van der Vleuten, Cees P. M.

    2008-01-01

    OBJECTIVE: To test hypotheses regarding the longitudinal effects of problem-based learning (PBL) and conventional learning relating to students' appreciation of the curriculum, self-assessment of general competencies, summative assessment of clinical competence and indicators of career development.

  15. Drug approval processes: A case study of rivaroxaban

    Directory of Open Access Journals (Sweden)

    Sally A Arif

    2013-01-01

    Full Text Available Rivaroxaban, a Xa inhibitor, was recently approved (March 2013 in the setting of post-acute coronary syndromes (ACS by the European Medicine Agency. This is in contrast to not being approved by the Food and Drug Agency in the United States for the same indication in 2012 and 2013. The FDA′s decision was based on a lack of follow-up data for the patients enrolled in the study based on the pivotal Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome (ATLAS-ACS 2-TIMI 51 trial. While both agencies have similar roles when functioning as drug regulatory bodies and goal of granting approval of safe and efficacious drugs, the difference in approval outcome in the case of rivaroxaban highlights the differences in drug review process when both agencies are presented with the same Phase 3 data to review.

  16. Zika antiviral chemotherapy: identification of drugs and promising starting points for drug discovery from an FDA-approved library [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Bruno S. Pascoalino

    2016-10-01

    Full Text Available Background The recent epidemics of Zika virus (ZIKV implicated it as the cause of serious and potentially lethal congenital conditions such microcephaly and other central nervous system defects, as well as the development of the Guillain-Barré syndrome in otherwise healthy patients. Recent findings showed that anti-Dengue antibodies are capable of amplifying ZIKV infection by a mechanism similar to antibody-dependent enhancement, increasing the severity of the disease. This scenario becomes potentially catastrophic when the global burden of Dengue and the advent of the newly approved anti-Dengue vaccines in the near future are taken into account. Thus, antiviral chemotherapy should be pursued as a priority strategy to control the spread of the virus and prevent the complications associated with Zika. Methods Here we describe a fast and reliable cell-based, high-content screening assay for discovery of anti-ZIKV compounds. This methodology has been used to screen the National Institute of Health Clinical Collection compound library, a small collection of FDA-approved drugs. Results and conclusion From 725 FDA-approved compounds triaged, 29 (4% were found to have anti-Zika virus activity, of which 22 had confirmed (76% of confirmation by dose-response curves. Five candidates presented selective activity against ZIKV infection and replication in a human cell line. These hits have abroad spectrum of chemotypes and therapeutic uses, offering valuable opportunities for selection of leads for antiviral drug discovery.

  17. Clinical performance of a light-cured denture base material compared to polymethylmethacrylate--a randomized clinical study.

    Science.gov (United States)

    Gohlke-Wehrße, Hanna-Lena; Giese-Kraft, Katja; Wöstmann, Bernd

    2012-06-01

    The aim of this study was to evaluate the clinical long-term performance of a visible light-cured resin (VLCR) denture base material and to compare it to a well-established polymethylmethacrylate (PMMA)-based denture acrylic in a randomized split-mouth clinical long-term study. One hundred removable partial dentures in 90 patients, with at least two saddles each, were investigated. One saddle was made of VLCR, while the other was made of PMMA at random. Plaque adhesion, tissue reaction, and technical parameters of the dentures were assessed 6, 12, and 18 months after treatment. Statistical analysis was performed using the Wilcoxon rank-sum test. Though VLCR showed higher plaque adhesion than PMMA after 6, 12, and 18 months (p denture acrylic and metal and the boundary between denture acrylic and denture tooth PMMA was rated higher than VLCR. The surface quality of the upper side of the denture saddles showed no significant differences (p > 0.05). Neither VLCR nor PMMA showed discoloration at any point in time (p > 0.05). It can be concluded that VLCR is a viable alternative for the production of removable dentures. Especially in patients with hypersensitivities to PMMA, VLCR is particularly suitable for clinical use.

  18. Clinical gait data analysis based on Spatio-Temporal features

    CERN Document Server

    Katiyar, Rohit

    2010-01-01

    Analysing human gait has found considerable interest in recent computer vision research. So far, however, contributions to this topic exclusively dealt with the tasks of person identification or activity recognition. In this paper, we consider a different application for gait analysis and examine its use as a means of deducing the physical well-being of people. The proposed method is based on transforming the joint motion trajectories using wavelets to extract spatio-temporal features which are then fed as input to a vector quantiser; a self-organising map for classification of walking patterns of individuals with and without pathology. We show that our proposed algorithm is successful in extracting features that successfully discriminate between individuals with and without locomotion impairment.

  19. CLINICAL DATABASE ANALYSIS USING DMDT BASED PREDICTIVE MODELLING

    Directory of Open Access Journals (Sweden)

    Srilakshmi Indrasenan

    2013-04-01

    Full Text Available In recent years, predictive data mining techniques play a vital role in the field of medical informatics. These techniques help the medical practitioners in predicting various classes which is useful in prediction treatment. One of such major difficulty is prediction of survival rate in breast cancer patients. Breast cancer is a common disease these days and fighting against it is a tough battle for both the surgeons and the patients. To predict the survivability rate in breast cancer patients which helps the medical practitioner to select the type of treatment a predictive data mining technique called Diversified Multiple Decision Tree (DMDT classification is used. Additionally, to avoid difficulties from the outlier and skewed data, it is also proposed to perform the improvement of training space by outlier filtering and over sampling. As a result, this novel approach gives the survivability rate of the cancer patients based on which the medical practitioners can choose the type of treatment.

  20. Fractographic features of glass-ceramic and zirconia-based dental restorations fractured during clinical function

    OpenAIRE

    Øilo, Marit; Hardang, Anne Dybdahl; Ulsund, Amanda Hembre; Gjerdet,Nils Roar

    2014-01-01

    Fractures during clinical function have been reported as the major concern associated with all-ceramic dental restorations. The aim of this study was to analyze the fracture features of glass-ceramic and zirconia-based restorations fractured during clinical use. Twenty-seven crowns and onlays were supplied by dentists and dental technicians with information about type of cement and time in function, if available. Fourteen lithium disilicate glass-ceramic restorations and 13 zirconia-based res...

  1. Machine learning-based analysis of MR radiomics can help to improve the diagnostic performance of PI-RADS v2 in clinically relevant prostate cancer.

    Science.gov (United States)

    Wang, Jing; Wu, Chen-Jiang; Bao, Mei-Ling; Zhang, Jing; Wang, Xiao-Ning; Zhang, Yu-Dong

    2017-04-03

    To investigate whether machine learning-based analysis of MR radiomics can help improve the performance PI-RADS v2 in clinically relevant prostate cancer (PCa). This IRB-approved study included 54 patients with PCa undergoing multi-parametric (mp) MRI before prostatectomy. Imaging analysis was performed on 54 tumours, 47 normal peripheral (PZ) and 48 normal transitional (TZ) zone based on histological-radiological correlation. Mp-MRI was scored via PI-RADS, and quantified by measuring radiomic features. Predictive model was developed using a novel support vector machine trained with: (i) radiomics, (ii) PI-RADS scores, (iii) radiomics and PI-RADS scores. Paired comparison was made via ROC analysis. For PCa versus normal TZ, the model trained with radiomics had a significantly higher area under the ROC curve (Az) (0.955 [95% CI 0.923-0.976]) than PI-RADS (Az: 0.878 [0.834-0.914], p Machine learning analysis of MR radiomics can help improve the performance of PI-RADS in clinically relevant PCa. • Machine-based analysis of MR radiomics outperformed in TZ cancer against PI-RADS. • Adding MR radiomics significantly improved the performance of PI-RADS. • DKI-derived Dapp and Kapp were two strong markers for the diagnosis of PCa.

  2. Mass spectrometry-based proteomics and analyses of serum: a primer for the clinical investigator.

    Science.gov (United States)

    Fusaro, V A; Stone, J H

    2003-01-01

    The vocabulary of proteomics and the swiftly-developing, technological nature of the field constitute substantial barriers to clinical investigators. In recent years, mass spectrometry has emerged as the most promising technique in this field. The purpose of this review is to introduce the field of mass spectrometry-based proteomics to clinical investigators, to explain many of the relevant terms, to introduce the equipment employed in this field, and to outline approaches to asking clinical questions using a proteomic approach. Examples of clinical applications of proteomic techniques are provided from the fields of cancer and vasculitis research, with an emphasis on a pattern recognition approach.

  3. Evidence-Based Medicine in Otolaryngology, Part 6: Patient-Reported Outcomes in Clinical Practice.

    Science.gov (United States)

    Carroll, Thomas L; Lee, Stella E; Lindsay, Robin; Locandro, Drew; Randolph, Gregory W; Shin, Jennifer J

    2017-09-01

    The assessment of patient-reported outcome measures (PROMs) in the outpatient setting is gaining momentum in clinical and research venues. Implementing this data capture into one's practice, however, is not a one-size-fits-all venture, and it is critical to determine when, how, and where to include these patient-centered assessments. This installment of the "Evidence-Based Medicine in Otolaryngology" series provides insight into the implementation process and experiences with successful incorporation of PROMs into clinical practice. Specifically, 4 differing clinical scenarios and collection techniques are described, including data acquisition protocols, formats for clinician data usage, and applications of PROM results in clinical and research scenarios.

  4. The Effect of Algorithm-Based Learning on Clinical Decision Making Abilities of Medical Emergency Students

    Directory of Open Access Journals (Sweden)

    H Asayesh

    2015-12-01

    Full Text Available Introduction: Improvement of students’ clinical decision making is one of the main challenges in medical education. There are numerous ways to improve these skills. The aim of this study was to examine the effect of algorithm-based learning on clinical decision making abilities of medical emergency students. Method: in this experimental study, twenty five medical emergency students were randomly assigned to algorithm based learning group  (n=13 and control group  (n=12. Student in algorithm-based learning group were educated the diagnosis and treatment of selected medical emergency situation with algorithmic approach. Education in the control group was conducted by a routine lecture, along with copies of educational content. Three-hour training period was held for both groups  (two separate sessions with an interval day. After intervention, clinical decision making of the students in both group were measured by clinical scenarios and clinical decision making self-efficacy scale. Results: The mean of acquired scores from clinical scenarios among students in algorithm-based learning group was 17.50  (±1.67 and in the control group was 14.50 (±2.63. The differences was statistically significant  (t=0.006, P=0.006. The students in algorithm-based learning group had better scores in the clinical decision making in terms of self-efficacy scale and it was 13.30 (1.57 and in the control group this mean was 10.32  (3.05. In this case, the differences was statistically significant (t=3.01, P=0.009. Conclusion: algorithm-based learning is effective in improvement of clinical decision making and applying of this method along with other educational methods could promote students’ clinical decision making especially in medical emergency situations.

  5. Acute care clinical pharmacy practice: unit- versus service-based models.

    Science.gov (United States)

    Haas, Curtis E; Eckel, Stephen; Arif, Sally; Beringer, Paul M; Blake, Elizabeth W; Lardieri, Allison B; Lobo, Bob L; Mercer, Jessica M; Moye, Pamela; Orlando, Patricia L; Wargo, Kurt

    2012-02-01

    This commentary from the 2010 Task Force on Acute Care Practice Model of the American College of Clinical Pharmacy was developed to compare and contrast the "unit-based" and "service-based" orientation of the clinical pharmacist within an acute care pharmacy practice model and to offer an informed opinion concerning which should be preferred. The clinical pharmacy practice model must facilitate patient-centered care and therefore must position the pharmacist to be an active member of the interprofessional team focused on providing high-quality pharmaceutical care to the patient. Although both models may have advantages and disadvantages, the most important distinction pertains to the patient care role of the clinical pharmacist. The unit-based pharmacist is often in a position of reacting to an established order or decision and frequently is focused on task-oriented clinical services. By definition, the service-based clinical pharmacist functions as a member of the interprofessional team. As a team member, the pharmacist proactively contributes to the decision-making process and the development of patient-centered care plans. The service-based orientation of the pharmacist is consistent with both the practice vision embraced by ACCP and its definition of clinical pharmacy. The task force strongly recommends that institutions pursue a service-based pharmacy practice model to optimally deploy their clinical pharmacists. Those who elect to adopt this recommendation will face challenges in overcoming several resource, technologic, regulatory, and accreditation barriers. However, such challenges must be confronted if clinical pharmacists are to contribute fully to achieving optimal patient outcomes.

  6. Preparing a 21st century workforce: is it time to consider clinically based, competency-based training of health practitioners?

    Science.gov (United States)

    Nancarrow, Susan A; Moran, Anna M; Graham, Iain

    2014-02-01

    Health workforce training in the 21st century is still based largely on 20th century healthcare paradigms that emphasise professionalisation at the expense of patient-focussed care. This is illustrated by the paradox of increased training times for health workers that have corresponded with workforce shortages, the limited career options and pathways for paraprofessional workers, and inefficient clinical training models that detract from, rather than add to, service capacity. We propose instead that a 21st century health workforce training model should be: situated in the clinical setting and supported by outsourced university training (not the other way around); based on the achievement of specific milestones rather than being time-defined; and incorporate para-professional career pathways that allow trainees to 'step-off' with a useable qualification following the achievement of specific competencies. Such a model could be facilitated by existing technology and clinical training infrastructure, with enormous potential for economies of scale in the provision of formal training. The benefits of a clinically based, competency-based model include an increase in clinical service capacity, and clinical training resources become a resource for the delivery of healthcare, not just education. Existing training models are unsustainable, and are not preparing a workforce with the flexibility the 21st century demands.

  7. Simulation-based education for building clinical teams

    Directory of Open Access Journals (Sweden)

    Marshall Stuart

    2010-01-01

    Full Text Available Failure to work as an effective team is commonly cited as a cause of adverse events and errors in emergency medicine. Until recently, individual knowledge and skills in managing emergencies were taught, without reference to the additional skills required to work as part of a team. Team training courses are now becoming commonplace, however their strategies and modes of delivery are varied. Just as different delivery methods of traditional education can result in different levels of retention and transfer to the real world, the same is true in team training of the material in different ways in traditional forms of education may lead to different levels of retention and transfer to the real world, the same is true in team training. As team training becomes more widespread, the effectiveness of different modes of delivery including the role of simulation-based education needs to be clearly understood. This review examines the basis of team working in emergency medicine, and the components of an effective emergency medical team. Lessons from other domains with more experience in team training are discussed, as well as the variations from these settings that can be observed in medical contexts. Methods and strategies for team training are listed, and experiences in other health care settings as well as emergency medicine are assessed. Finally, best practice guidelines for the development of team training programs in emergency medicine are presented.

  8. BASED TO CLINICAL CASE. VON HIPLEA-LINDAU SYNDROME

    Directory of Open Access Journals (Sweden)

    Brzeziński Piotr

    2011-01-01

    Full Text Available von Hippel-Lindau syndrome (VHL is a rare, genetic multi-system disorder characterized by the abnormal growth of tumors in certain parts of the body (angiomatosis. The tumors of the central nervous system (CNS are benign and are comprised of a nest of blood vessels and are called hemangioblastomas. Hemangioblastomas may develop in the brain, the retina of the eyes, and other areas of the nervous system. Other types of tumors develop in the adrenal glands, the kidneys, or the pancreas. Symptoms of VHL vary among patients and depend on the size and location of the tumors. Symptoms may include headaches, problems with balance and walking, dizziness, weakness of the limbs, vision problems, and high blood pressure. Cysts (fluid-filled sacs and/or tumors (benign or cancerous may develop around the hemangioblastomas and cause the symptoms listed above. Individuals with VHL are also at a higher risk than normal for certain types of cancer, especially kidney cancer. Based on the case of 30-year old patient with characteristics of von Hippel-Lindau syndrome as phakomatosis.

  9. CLINICAL SURFACES -- Activity-Based Computing for Distributed Multi-Display Environments in Hospitals

    DEFF Research Database (Denmark)

    Bardram, Jakob Eyvind; Bunde-Pedersen, Jonathan; Doryab, Afsaneh

    2009-01-01

    and browsing of patient data on public displays. We present the design and implementation of CLINICAL SURFACES, and report from an evaluation of the system at a large hospital. The evaluation shows that using distributed public displays to support activity-based computing inside a hospital is very useful...... and activities that the MDE is being used for. This paper presents a novel approach to support activity-based computing in distributed MDEs, where displays are physically distributed across a large building. CLINICAL SURFACES was designed for clinical work in hospitals, and enables context-sensitive retrieval...... for clinical work, and that the apparent contradiction between maintaining privacy of medical data in a public display environment can be mitigated by the use of CLINICAL SURFACES....

  10. Evidence-based early clinical detection of emerging diseases in food animals and zoonoses: two cases.

    Science.gov (United States)

    Saegerman, Claude; Humblet, Marie-France; Porter, Sarah Rebecca; Zanella, Gina; Martinelle, Ludovic

    2012-03-01

    If diseases of food-producing animals or zoonoses (re-)emerge, early clinical decision making is of major importance. In this particular condition, it is difficult to apply a classic evidence-based veterinary medicine process, because of a lack of available published data. A method based on the partition of field clinical observations (evidences) could be developed as an interesting alternative approach. The classification and regression tree (CART) analysis was used to improve the early clinical detection in two cases of emerging diseases: bovine spongiform encephalopathy (mad cow disease) and bluetongue due to the serotype 8-virus in cattle.

  11. Electronic data capture platform for clinical research based on mobile phones and near field communication technology.

    Science.gov (United States)

    Morak, Jürgen; Schwetz, Verena; Hayn, Dieter; Fruhwald, Friedrich; Schreier, Gunter

    2008-01-01

    Electronic data capture systems support data acquisition for clinical research and enable the evaluation of new investigational medical devices. In case of evaluating a device the most challenging part is the user interface i.e. the solution how to acquire the data within a clinical setting and to synchronize them with a web-based data centre. The aim of this paper is to describe the development of an electronic data capture system with a mobile data input solution based on mobile phones and Near Field Communication technology. This system was evaluated within a real clinical setting and demonstrated high usability, security and reliability.

  12. Six school-based clinics: their reproductive health services and impact on sexual behavior.

    Science.gov (United States)

    Kirby, D; Waszak, C; Ziegler, J

    1991-01-01

    An evaluation of the reproductive health programs of six diverse school-based clinics measured the impact of the clinics on sexual behavior and contraceptive use. All six clinics served low-income populations; at five of them, the great majority of the students served were black. An analysis of student visits by type of care given found that these clinics were not primarily family planning facilities; rather, they provided reproductive health care as one component of a comprehensive health program. Student survey data collected in the clinic schools and nearby comparison schools (four sites) or collected both before the clinic opened and two years later (two sites) indicated that the clinics neither hastened the onset of sexual activity nor increased its frequency. The clinics had varying effects on contraceptive use. Providing contraceptives on site was not enough to significantly increase their use; in only one of the three sites that did so were students in the clinic school significantly more likely than students in the comparison school to have used birth control during last intercourse. However, condom use rose sharply at one clinic school that had a strong AIDS education program and was located in a community where AIDS was a salient issue. At another clinic school, where pregnancy prevention was a high priority and staff issued vouchers for contraceptives, the use of condoms and pills was significantly higher than in the comparison school. A third clinic school--which focused on high-risk youth, emphasized pregnancy prevention and dispensed birth control pills--recorded a significantly higher use of pills than its comparison school. Although the data suggest that the clinics probably prevented small numbers of pregnancies at some schools, none of the clinics had a statistically significant effect on school-wide pregnancy rates.

  13. Clinical trials for stem cell transplantation: when are they needed?

    Science.gov (United States)

    Van Pham, Phuc

    2016-04-27

    In recent years, both stem cell research and the clinical application of these promising cells have increased rapidly. About 1000 clinical trials using stem cells have to date been performed globally. More importantly, more than 10 stem cell-based products have been approved in some countries. With the rapid growth of stem cell applications, some countries have used clinical trials as a tool to diminish the rate of clinical stem cell applications. However, the point at which stem cell clinical trials are essential remains unclear. This commentary discusses when stem cell clinical trials are essential for stem cell transplantation therapies.

  14. Profile of a unique community-based clinical pharmacy family practice program.

    Science.gov (United States)

    Leff, R D; Helling, D K; Smith, F W; Probasco, R W; Pfeiffer, F G

    1981-01-01

    The provision of clinical pharmaceutical services in family practice offices has aroused considerable national interest among both pharmacists and physicians. Many of these clinical pharmaceutical services and educational programs have been university-funded and/or rely on colleges of pharmacy for fiscal support. Few examples of community-funded, ambulatory care clinical pharmaceutical programs have been reported. Community Health Care, Inc., and Davenport Medical Education Foundation, Inc., are two health care programs which sponsor an innovative ambulatory care clinical pharmacy program. Community Health Care is a nonprofit corporation which utilizes a multidisciplinary team concept to provide comprehensive ambulatory care services to patients. Davenport Medical Education Foundation is a nonprofit corporation that provides a community-based family practice residency program. Because the two separate parent organizations have distinct goals requiring individualized clinical pharmaceutical services, the responsibilities of the clinical pharmacist have evolved to be comprehensive in scope.

  15. Evidence-based clinical practice guidelines for bladder cancer (summary - JUA 2009 Edition).

    Science.gov (United States)

    2010-02-01

    In Japan, until now, the treatment of bladder cancer has been based on guidelines from overseas. The problem with this practice is that the options recommended in overseas guidelines are not necessarily suitable for Japanese clinical practice. A relatively large number of clinical trials have been conducted in Japan in the field of bladder cancer, and the Japanese Urological Association (JUA) considered it appropriate to formulate their own guidelines. These Guidelines present an overview of bladder cancer at each clinical stage, followed by clinical questions that address problems frequently faced in everyday clinical practice. In this English translation of a shortened version of the original Guidelines, we have abridged each overview, summarized each clinical question and its answer, and only included the references we considered of particular importance.

  16. 9 CFR 147.52 - Approved tests.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Approved tests. 147.52 Section 147.52... Approved Tests § 147.52 Approved tests. (a) The procedures for the bacteriological examination of poultry and poultry environments described in this part are approved tests for use in the NPIP. In...

  17. Clinical capabilities of graduates of an outcomes-based integrated medical program

    Directory of Open Access Journals (Sweden)

    Scicluna Helen A

    2012-06-01

    Full Text Available Abstract Background The University of New South Wales (UNSW Faculty of Medicine replaced its old content-based curriculum with an innovative new 6-year undergraduate entry outcomes-based integrated program in 2004. This paper is an initial evaluation of the perceived and assessed clinical capabilities of recent graduates of the new outcomes-based integrated medical program compared to benchmarks from traditional content-based or process-based programs. Method Self-perceived capability in a range of clinical tasks and assessment of medical education as preparation for hospital practice were evaluated in recent graduates after 3 months working as junior doctors. Responses of the 2009 graduates of the UNSW’s new outcomes-based integrated medical education program were compared to those of the 2007 graduates of UNSW’s previous content-based program, to published data from other Australian medical schools, and to hospital-based supervisor evaluations of their clinical competence. Results Three months into internship, graduates from UNSW’s new outcomes-based integrated program rated themselves to have good clinical and procedural skills, with ratings that indicated significantly greater capability than graduates of the previous UNSW content-based program. New program graduates rated themselves significantly more prepared for hospital practice in the confidence (reflective practice, prevention (social aspects of health, interpersonal skills (communication, and collaboration (teamwork subscales than old program students, and significantly better or equivalent to published benchmarks of graduates from other Australian medical schools. Clinical supervisors rated new program graduates highly capable for teamwork, reflective practice and communication. Conclusions Medical students from an outcomes-based integrated program graduate with excellent self-rated and supervisor-evaluated capabilities in a range of clinically-relevant outcomes. The program

  18. Community vs. Clinic-Based Modular Treatment of Children with Early-Onset ODD or CD: A Clinical Trial with 3-Year Follow-Up

    Science.gov (United States)

    Kolko, David J.; Dorn, Lorah D.; Bukstein, Oscar G.; Pardini, Dustin; Holden, Elizabeth A.; Hart, Jonathan

    2009-01-01

    This study examines the treatment outcomes of 139, 6-11 year-old, clinically referred boys and girls diagnosed with Oppositional Defiant Disorder (ODD) or Conduct Disorder (CD) who were randomly assigned to a modular-based treatment protocol that was applied by research study clinicians either in the community (COMM) or a clinic office (CLINIC).…

  19. [Evidence-Based Knowledge Translation: From Scientific Evidence to Clinical Nursing Practice].

    Science.gov (United States)

    Chen, Kee-Hsin; Kao, Ching-Chiu; Chen, Chiehfeng

    2016-12-01

    In 1992, Gordon Guyatt coined the term "evidence-based medicine", which has since attracted worldwide attention. In 2007, the Institute of Medicine's Roundtable on Evidence-Based Medicine set the goal that 90% of clinical decisions would be supported by accurate, timely, and up-to-date clinical information and would reflect the best available evidence by 2020. However, the chasm between knowing and doing remains palpable. In 2000, the Canadian Institute of Health Research applied the term "knowledge translation" to describe the bridge that is necessary to cross the gap between research knowledge and clinical practice. The present paper outlines the conceptual framework, barriers, and promotion strategies for evidence-based knowledge translation and shares clinical experience related to overcoming the seven layers of leakage (aware, accepted, applicable, able, acted on, agreed, and adhered to). We hope that this paper can enhance the public well-being and strengthen the future health care system.

  20. Task-based learning: the answer to integration and problem-based learning in the clinical years.

    Science.gov (United States)

    Harden, R; Crosby, J; Davis, M H; Howie, P W; Struthers, A D

    2000-05-01

    Integrated teaching and problem-based learning (PBL) are powerful educational strategies. Difficulties arise, however, in their application in the later years of the undergraduate medical curriculum, particularly in clinical attachments. Two solutions have been proposed - the use of integrated clinical teaching teams and time allocated during the week for PBL separate from the clinical work. Both approaches have significant disadvantages. Task-based learning (TBL) is a preferred strategy. In TBL, a range of tasks undertaken by a doctor are identified, e.g. management of a patient with abdominal pain, and these are used as the focus for learning. Students have responsibility for integrating their learning round the tasks as they move through a range of clinical attachments in different disciplines. They are assisted in this process by study guides. The implementation of TBL is described in one medical school. One hundred and thirteen tasks, arranged in 16 groups, serve to integrate the student learning as they rotate through 10 clinical attachments. This trans-disciplinary approach to integration, which incorporates the principles of PBL offers advantages to both teachers and students. It recognizes that clinical attachments in individual disciplines can offer rich learning opportunities and that such attachments can play a role in an integrated, as well as in a traditional, curriculum. In TBL, the contributions of the clinical attachments to the curriculum learning outcomes must be clearly defined and tasks selected which will serve as a focus for the integration of the students' learning over the range of attachments.

  1. Development of a Ki-67-based clinical trial assay for neoadjuvant endocrine therapy response monitoring in breast cancer.

    Science.gov (United States)

    Goncalves, Rodrigo; DeSchryver, Katherine; Ma, Cynthia; Tao, Yu; Hoog, Jeremy; Cheang, Maggie; Crouch, Erika; Dahiya, Neha; Sanati, Souzan; Barnes, Michael; Sarian, Luis Otávio Zanatta; Olson, John; Allred, Donald Craig; Ellis, Matthew J

    2017-09-01

    The recent publication of the ACOSOG Z1031 trial results demonstrated that Ki-67 proliferation marker-based neoadjuvant endocrine therapy response monitoring could be used for tailoring the use of adjuvant chemotherapy in ER+HER2-negative breast cancer patients. In this paper, we describe the development of the Ki-67 clinical trial assay used for this study. Ki-67 assay assessment focused on reproducing a 2.7% Ki-67 cut-point (CP) required for calculating the Preoperative Endocrine Prognostic Index and a 10% CP for poor endocrine therapy response identification within the first month of neoadjuvant endocrine treatment. Image analysis was assessed to increase the efficiency of the scoring process. Clinical outcome concordance for two independent Ki-67 scores was the primary performance metric. Discordant scores led to a triage approach where cases with complex histological features that software algorithms could not resolve were flagged for visual point counting (17%). The final Ki-67 scoring approach was run on T1/2 N0 cases from the P024 and POL trials (N = 58). The percent positive agreement for the 2.7% CP was 87.5% (95% CI 61.7-98.5%); percent negative agreement 88.9% (95% CI: 65.3-98.6%). Minor discordance did not affect the ability to predict similar relapse-free outcomes (Log-Rank P = 0.044 and P = 0.055). The data for the 10% early triage CP in the POL trial were similar (N = 66), the percentage positive agreement was 100%, and percent negative agreement 93.55% (95% CI: 78.58-99.21%). The independent survival predictions were concordant (Log-rank P = 0.0001 and P = 0.01). We have developed an efficient and reproducible Ki-67 scoring system that was approved by the Clinical Trials Evaluation Program for NCI-supported neoadjuvant endocrine therapy trials. Using the methodology described here, investigators are able to identify a subgroup of patients with ER+HER2-negative breast cancer that can be safely managed without the need of adjuvant

  2. Problem based learning (PBL) vs. Case based curriculum in clinical clerkship, Internal Medicine innovated Curriculum, Student prospective.

    Science.gov (United States)

    Aljarallah, Badr; Hassan, Mohammad Saleh

    2015-04-01

    The vast majority of PBL experience is in basic science courses. Application of classic Problem based learning in clerkship phase is challenging. Although the clinical case is considered a problem, yet solving this problem following the burrow's law has faced hurdles. The difficulties are facing the learner, the teacher and curricula. We implement innovative curriculum for the clerkship year in internal medicine course. We surveyed the student just before coming to an internal medicine course to ask them about continuing PBL or other types of learning in clinical years. A committee was created to study the possible ways to integrate PBL in the course. After multiple brainstorming meeting, an innovated curriculum was implemented. Student surveyed again after they completed their course. The survey is asking them about what is the effect of the implemented curriculum in their skills, attitude, and knowledge. 70% of Students, who finished their basic science in PBL, preferred not to have classical PBL, but more a clinical oriented case based curriculum in the clinical years. After this innovated curriculum, 50-60 % of students who completed it showed a positive response in all aspects of effects including skill, attitude, and knowledge. The Innovated curriculum includes daily morning report, 3 bedside teaching, investigation session, and clinical reasoning weekly, and Lectures up to twice a week. We suggest implementing a curriculum with PBL and case-based criteria in clinical phase are feasible, we are providing a framework with this innovated curriculum.

  3. Clinical REM sleep behavior disorder and motor subtypes in Parkinson's disease: a questionnaire-based study.

    Science.gov (United States)

    Aygun, Dursun; Turkel, Yakup; Onar, Musa Kazım; Sunter, Tevfik

    2014-04-01

    Studies documenting the association between rapid eye movement sleep behavior disorder (RBD) and motor subtypes in Parkinson's disease (PD) are rare. Our hypothesis is that RBD may be more severe in non-tremor dominant (NTD) patients with RBD than those tremor dominant (TD) with RBD. In this study, we investigated the association between motor subtypes and clinical RBD in PD. We evaluated 104 consecutive patients older than 18 years presenting with PD to the Neurology Clinic of the University Hospital for one year in this study. The clinical diagnosis of RBD was based on the minimal diagnostic criteria of International Classification of Sleep Disorders, revised. The Stavanger Sleepiness Questionnaire was used to rate the severity of clinical RBD. The patients were divided into two subgroups as TD and NTD. The patient and control groups were compared with each other for severity and frequency of clinical RBD, and the Unified Parkinson's Disease Rating Scale (UPDRS) and Hoehn-Yahr stage scores. The correlation between severity of clinical RBD and clinical severity of PD was analyzed in the patient groups. Of the patients, 45.2% (n=47) had the NTD subtype of PD and 54.8% (n=57) had the TD subtype of PD. There was no significant difference among the groups in terms of frequency and severity of clinical RBD. For the NTD patients, there was a weak positive correlation between severity of clinical RBD and clinical severity of PD. However, there was no correlation in the TD subgroup. In our study, frequency of clinical RBD was unrelated to motor subtypes of PD. However, in the present study, we found a weak correlation between clinical severity (UPDRS and the Hoehn-Yahr) of PD and severity of clinical RBD in the NTD subtype but not in the TD subtype. Copyright © 2014 Elsevier B.V. All rights reserved.

  4. New Approaches to Antibiotic Use and Review of Recently Approved Antimicrobial Agents.

    Science.gov (United States)

    Hahn, Andrew W; Jain, Rupali; Spach, David H

    2016-07-01

    Antimicrobial drug-resistance continues to force adaptation in our clinical practice. We explore new evidence regarding adjunctive antibiotic therapy for skin and soft tissue abscesses as well as duration of therapy for intra-abdominal abscesses. As new evidence refines optimal practice, it is essential to support clinicians in adopting practice patterns concordant with evidence-based guidelines. We review a simple approach that can 'nudge' clinicians towards concordant practices. Finally, the use of novel antimicrobials will play an increasingly important role in contemporary therapy. We review five new antimicrobials recently FDA-approved for use in drug-resistant infections: dalbavancin, oritavancin, ceftaroline, ceftolozane-tazobactam, and ceftazidime-avibactam.

  5. NCI Community Oncology Research Program Approved | Division of Cancer Prevention

    Science.gov (United States)

    On June 24, 2013, the National Cancer Institute (NCI) Board of Scientific Advisors approved the creation of the NCI Community Oncology Research Program (NCORP). NCORP will bring state-of-the art cancer prevention, control, treatment and imaging clinical trials, cancer care delivery research, and disparities studies to individuals in their own communities. |

  6. Person-centric clinical trials: an opportunity for the good clinical practice (GCP)-practice-based research network.

    Science.gov (United States)

    Curro, Frederick A; Robbins, Dennis A; Millenson, Michael L; Fox, Chester H; Naftolin, Frederick

    2013-10-01

    Practice-based research networks (PBRNs) can function as a platform for delivery of patient-centered care consistent with the Patient Protection and Affordable Care Act. Patient-centered (centric) clinical studies encourage the patient to be an integral part of study design and outcome. The patient's electronic health record contributes to the shared national health care data set. PBRNs integrate health care data in real time at the point of care and reflect the full context of the person's health. PBRNs designed under the principles of good clinical practice (GCP) validate studies related to comparative effectiveness research and drug development. PBRNs can generate large amounts of data from known patient histories so that side effects can be assessed in their totality. The larger and more diverse number of patients recruited suggests that point-of-care-data, where both provider and patient participate in the treatment, may be more robust in that side effects, drug-drug interactions and number of concomitant medications used may be identified earlier in the development process. The GCP PBRN concept affords continuous patient information for both care and research purposes. These all contribute to an ethical approach for the pharmaceutical industry to generate clinical research data for regulatory submission and to contribute to a HIPAA-compliant national database that could contribute to improved health care delivery and pharmacovigilance.

  7. 21 CFR 814.45 - Denial of approval of a PMA.

    Science.gov (United States)

    2010-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.45 Denial of approval of a... validity of the study; or (5) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 or informed consent regulations in...

  8. 21 CFR 814.46 - Withdrawal of approval of a PMA.

    Science.gov (United States)

    2010-04-01

    ...) MEDICAL DEVICES PREMARKET APPROVAL OF MEDICAL DEVICES FDA Action on a PMA § 814.46 Withdrawal of approval... of the study. (4) Any clinical investigation involving human subjects described in the PMA, subject to the institutional review board regulations in part 56 or informed consent regulations in part...

  9. Developing an understanding of research-based nursing pedagogy among clinical instructors: a qualitative study.

    Science.gov (United States)

    Zakari, Nazik M A; Hamadi, Hanadi Y; Salem, Olfat

    2014-11-01

    Effective instruction is imperative to the learning process of clinical nursing instructors. Faculty members are required to provide high-quality teaching and training by using new ways of teaching pedagogical methods to clinical instructors, which have transformed pedagogies from an exclusive clinical model to a holistic model. The purpose of this study was to explore clinical instructors' use of planning, implementation, feedback loops, and reflection frameworks to apply research-based teaching and to examine the pedagogy used during field experience. Data for the qualitative study were obtained from twenty purposefully sampled clinical teachers (n=20) via lists of questioned instructional practices and discussions, semi-structured interviews, observational notes, field notes, and written reflections. Data were analyzed by using a triangulation method to ensure trustworthiness, credibility, and reliability. Three main themes emerged regarding the use of research-based teaching strategies: the need for learning about research-based pedagogy, support mechanisms to implement innovative teaching strategies, and transitioning from nursing student to nursing clinical instructors. It has been well documented that the nursing profession faces a serious shortage of nursing faculty, impacting the quality of clinical teaching. Developing clinical instructor programs to give students opportunities to select instructor pathways, focusing on knowledge promoting critical thinking and life-long professional development, is essential. Nursing colleges must collaborate by using a partnership model to achieve competency in planning, implementation, feedback loops, and reflection. Applying research-based clinical teaching requires the development of programs that integrate low-fidelity simulation and assisted instruction through the use of computers in Nursing Colleges. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. Relationship of clinic-based gait speed measurement to limitations in community-based activities in older adults.

    Science.gov (United States)

    Verghese, Joe; Wang, Cuiling; Holtzer, Roee

    2011-05-01

    To examine the ability of clinic-based assessments of gait speed to capture limitations in a broad range of home- and community-based activities. Cross-sectional study. Community-based aging cohort study. Community-residing subjects (N=655; 61% women; age ≥70y; mean, 80.4y). None. Limitations on 3 gait-related activities of daily living (walking inside home, climbing up and down stairs) and 6 motor-based but gait-independent activities (bathing, dressing, getting up from a chair, toileting, shopping, using public transportation). Gait speed was associated with the presence of self-reported difficulty for all 3 home-based activities that were directly gait related and 5 of 6 motor-based activities. Gait speed of 1m/s or less was associated with increased risk for limitations on at least 1 of the 9 selected activities (odds ratio, 3.21; 95% confidence interval, 2.24-4.58; Pspeed measured in clinical settings has ecologic validity as a clinical marker of functional status in older adults for use in clinical and research settings. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  11. Clinical applications of PD-1-based therapy: a focus on pembrolizumab (MK-3475 in the management of melanoma and other tumor types

    Directory of Open Access Journals (Sweden)

    Gangadhar TC

    2015-04-01

    Full Text Available Tara C Gangadhar,1 April KS Salama2 1Division of Hematology/Oncology, Department of Medicine, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA; 2Division of Medical Oncology, Department of Medicine, Duke University Medical Center, Durham, NC, USA Abstract: Preclinical work has led to an increased understanding of the immunomodulatory mechanisms involved in the regulation of the antitumor response in a variety of tumor types. PD-1 (programmed death 1 appears to be a key checkpoint involved in immune suppression in the tumor microenvironment, even in diseases not previously thought to be sensitive to immune manipulation. More recently, the subsequent clinical development of PD-1-based therapy has resulted in a major breakthrough in the field of oncology. Pembrolizumab, a humanized highly selective IgG4 anti-PD-1 monoclonal antibody, was recently approved for the treatment of advanced melanoma based on promising early-phase clinical data. Encouraging results have also been seen in other malignancies, and PD-1-targeted therapies are likely to markedly change the treatment landscape. Future work will center on rationally designed combination strategies in order to potentiate the antitumor immune response and overcome mechanisms of resistance. Keywords: PD-1, cancer, pembrolizumab, nivolumab, immunotherapy, antitumor activity 

  12. Systematic quality improvement in healthcare: clinical performance measurement and registry-based feedback

    NARCIS (Netherlands)

    van der Veer, S.N.

    2012-01-01

    The work in this thesis showed that some aspects of care quality cannot be fully captured by one measure, that the positive impact of registry-based feedback on clinical performance is not self-evident, and that it is difficult to build a strong evidence base on how this impact can be increased. Yet

  13. Clinical Outlook for Type-1 and FOXP3+ T Regulatory Cell-Based Therapy

    Science.gov (United States)

    Gregori, Silvia; Passerini, Laura; Roncarolo, Maria-Grazia

    2015-01-01

    T regulatory cells (Tregs) are subsets of T lymphocytes specialized in modulating antigen-specific immune responses in vivo. Hence, Tregs represent an ideal therapeutic tool to control detrimental immune reactions. Based on solid pre-clinical results, investigators started testing the safety and efficacy of Treg-based therapies in humans. Despite promising results, a number of issues remain to be solved. We will discuss the results obtained from clinical trials and the challenges and risks we are facing in the further development of Treg-based therapies. PMID:26635807

  14. Defining Emergency Department Necessary Policies Based on Clinical Governance Accreditation Scores

    Directory of Open Access Journals (Sweden)

    Mehrdad Esmailian

    2015-05-01

    Full Text Available Introduction: The role of accreditation scheme in quality improvement of emergency departments (ED has not been thoroughly evaluated in studies. Therefore, this study was designed to appraise the effects of policies defined based on clinical governance accreditation scores, on improvement of the procedures in ED. Methods: The present cohort study was carried out in the ED of Alzahra University Hospital, Isfahan, Iran in 2012-2013. In 2012 the deficiencies in ED of this hospital was determined based on clinical governance indicators. Then the deficiencies were classified based on their importance and changes were made in the ED. Finally, the effects of the changes were evaluated in August 2013. Results: The evaluation made in 2012 showed that 23 clinical and non-clinical procedures were carried out with deficiencies. Over the mentioned period, 6 (26.1% procedures were not done at all, while 17 (73.9% were done without a policy and irregularly. The overall score for clinical and non-clinical procedures in the ED before carrying out the accreditation scheme was 43 / 230 (18.7% of the maximum possible score. The score was raised to 222 equal to 96.5% of the maximum possible score after carrying out the scheme. This increase was statistically significant (p < 0.001. Conclusion: The findings of the present study showed that defining policies for improving the procedures carried out in ED based on accreditation scheme leads to improvement of medical services in ED.

  15. Evidence-based treatment of stuttering: II. Clinical significance of behavioral stuttering treatments.

    Science.gov (United States)

    Finn, Patrick

    2003-01-01

    An evidence-based framework can be described as an empirically-driven, measurement-based, client-sensitive approach for selecting treatments. It is believed that using such a framework is more likely to result in a clinically significant outcome. For this paper, a clinically significant outcome was defined as a meaningful treatment change. It was suggested that there are at least three groups for whom a treatment's outcome is meaningful. These groups include clinicians/clinical researchers, the clients, and relevant others who have some interest in the outcome (e.g., parents of a child who stutters). The meaning and measurement of clinical significance was discussed for each of these three groups, based on research from the behavioral stuttering treatment literature. The reader will learn about and be able to (1) broadly define a clinically significant outcome and identify some of the groups who are interested in such an outcome and (2) describe how clinical significance has been evaluated in stuttering treatment within an evidence-based framework.

  16. Electronic Approval of Invoices (AEF)

    CERN Multimedia

    2003-01-01

    With a view to the simplification of administrative procedures, AS and FI Divisions have drawn up a new procedure for the electronic approval of invoices via the EDH application. The aim of this new procedure is to rationalise the invoice approval process, notably by eliminating paper copies from the approval circuit. This will simplify the processing of invoices and facilitate their timely settlement, while at the same time maintaining a high level of security. This new procedure, in its current phase, will be gradually implemented from 1 November 2003 onwards. For clarification and further information, please see: http://ais.cern.ch/projs/AEF/help/help.htm . Finance Division, Accounts Payable Tel.: 7.22.95

  17. Primary oral health service provision in Aboriginal Medical Services-based dental clinics in Western Australia.

    Science.gov (United States)

    Kruger, Estie; Perera, Irosha; Tennant, Marc

    2010-01-01

    Australians living in rural and remote areas have poorer access to dental care. This situation is attributed to workforce shortages, limited facilities and large distances to care centres. Against this backdrop, rural and remote Indigenous (Aboriginal) communities in Western Australia seem to be more disadvantaged because evidence suggests they have poorer oral health than non-Indigenous people. Hence, provision of dental care for Aboriginal populations in culturally appropriate settings in rural and remote Western Australia is an important public health issue. The aim of this research was to compare services between the Aboriginal Medical Services (AMS)-based clinics and a typical rural community clinic. A retrospective analysis of patient demographics and clinical treatment data was undertaken among patients who attended the dental clinics over a period of 6 years from 1999 to 2004. The majority of patients who received dental care at AMS dental clinics were Aboriginal (95.3%), compared with 8% at the non-AMS clinic. The rate of emergency at the non-AMS clinic was 33.5%, compared with 79.2% at the AMS clinics. The present study confirmed that more Indigenous patients were treated in AMS dental clinics and the mix of dental care provided was dominated by emergency care and oral surgery. This indicated a higher burden of oral disease and late utilisation of dental care services (more focus on tooth extraction) among rural and remote Indigenous people in Western Australia.

  18. Competency-based education in a clinical course in conservative dentistry.

    Science.gov (United States)

    Yip, H K; Smales, R J; Newsome, P R; Chu, F C; Chow, T W

    2001-11-10

    The conceptual difference between a competency-based education and an education based upon a conventional dental curriculum is, perhaps, the starting point for the development of new curricula. The two systems are not, in themselves, exclusive. There is common ground to be found, and the concept of combining instruction with competency-based learning experiences is emerging in recent publications. This paper describes a competency-based approach applied to a clinical course in conservative dentistry. The learning outcomes of the fourth-year dental students in the new course were assessed using methods that included continuous clinical assessments, student presentations and peer-group reflective evaluations, patient management reviews, a clinical progress examination, the range and amount of work completed, and a written examination and viva voce. Different weightings were given to various elements of the assessment. A formal student assessment of the course rated it as being satisfactory.

  19. FDA Approval: Palbociclib for the Treatment of Postmenopausal Patients with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer.

    Science.gov (United States)

    Beaver, Julia A; Amiri-Kordestani, Laleh; Charlab, Rosane; Chen, Wei; Palmby, Todd; Tilley, Amy; Zirkelbach, Jeanne Fourie; Yu, Jingyu; Liu, Qi; Zhao, Liang; Crich, Joyce; Chen, Xiao Hong; Hughes, Minerva; Bloomquist, Erik; Tang, Shenghui; Sridhara, Rajeshwari; Kluetz, Paul G; Kim, Geoffrey; Ibrahim, Amna; Pazdur, Richard; Cortazar, Patricia

    2015-11-01

    On February 3, 2015, the FDA granted accelerated approval to palbociclib (IBRANCE, Pfizer Inc.), an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), for use in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The approval is based on a randomized, multicenter, open-label phase I/II trial (PALOMA-1) in 165 patients randomized to palbociclib (125 mg orally daily for 21 consecutive days, followed by 7 days off treatment) plus letrozole (2.5 mg orally daily) or letrozole alone. The phase II portion of the trial was divided into two cohorts: cohort 1 enrolled 66 biomarker-unselected patients and cohort 2 enrolled 99 biomarker-positive patients. The major efficacy outcome measure was investigator-assessed progression-free survival (PFS). A large magnitude of improvement in PFS was observed in patients receiving palbociclib plus letrozole compared with patients receiving letrozole alone (HR, 0.488; 95% confidence interval, 0.319-0.748). Multiple sensitivity analyses were supportive of clinical benefit. The most common adverse reaction in patients receiving palbociclib plus letrozole was neutropenia. This article summarizes the FDA thought process and data supporting accelerated approval based on PALOMA-1 that may be contingent upon verification and description of clinical benefit in the ongoing and fully accrued confirmatory trial PALOMA-2. ©2015 American Association for Cancer Research.

  20. Safe in the city: developing an effective video-based intervention for STD clinic waiting rooms.

    Science.gov (United States)

    Myint-U, Athi; Bull, Sheana; Greenwood, Gregory L; Patterson, Jocelyn; Rietmeijer, Cornelis A; Vrungos, Shelley; Warner, Lee; Moss, Jesse; O'Donnell, Lydia N

    2010-05-01

    There is a strong need for inexpensive, easily administered HIV and STD prevention interventions that are highly replicable and appealing to diverse clinic audiences. This article describes the four-step iterative and collaborative process used by the Safe City Study Group to design and develop a brief video-based intervention: Safe in the City. Step 1 involves identification of an appropriate intervention medium, a theoretical framework, and key messages; Step 2, collaboration with a film company to integrate the framework and key messages into an entertaining product; Step 3, facilitation of a multistep participatory process involving input from members of the priority audience (clinic patients), clinic staff, and community reviewers; and Step 4, pilot-testing to determine structural barriers to patients' viewing the video in clinic waiting rooms. Safe in the City has been demonstrated to reduce incident STDs among clinic patients in three cities in the United States.

  1. Development and clinical study of mobile 12-lead electrocardiography based on cloud computing for cardiac emergency.

    Science.gov (United States)

    Fujita, Hideo; Uchimura, Yuji; Waki, Kayo; Omae, Koji; Takeuchi, Ichiro; Ohe, Kazuhiko

    2013-01-01

    To improve emergency services for accurate diagnosis of cardiac emergency, we developed a low-cost new mobile electrocardiography system "Cloud Cardiology®" based upon cloud computing for prehospital diagnosis. This comprises a compact 12-lead ECG unit equipped with Bluetooth and Android Smartphone with an application for transmission. Cloud server enables us to share ECG simultaneously inside and outside the hospital. We evaluated the clinical effectiveness by conducting a clinical trial with historical comparison to evaluate this system in a rapid response car in the real emergency service settings. We found that this system has an ability to shorten the onset to balloon time of patients with acute myocardial infarction, resulting in better clinical outcome. Here we propose that cloud-computing based simultaneous data sharing could be powerful solution for emergency service for cardiology, along with its significant clinical outcome.

  2. Electronically implemented clinical indicators based on a data warehouse in a tertiary hospital: its clinical benefit and effectiveness.

    Science.gov (United States)

    Yoo, Sooyoung; Kim, Seok; Lee, Kee-Hyuck; Jeong, Chang Wook; Youn, Sang Woong; Park, Kyoung Un; Moon, So Young; Hwang, Hee

    2014-07-01

    Assessing and monitoring care and service using clinical indicators (CIs) can allow the measurement of and lead to improvements in the quality of care. However, the management and maintenance of CI data has been shown to be difficult because the data are usually collected and provided manually. In this study, for the purpose of efficient managing quality indicators, a data warehouse (DW)-based CI monitoring system was developed. The clinical effectiveness and efficiency of a DW-based CI monitoring was investigated through several case studies of the system's operation at a tertiary hospital. This study analyzed the CIs that have been developed over the past 8 years at a 1340-bed tertiary general university hospital in South Korea to improve and monitor the quality of care and patient safety. The hospital was opened as a fully digital hospital in 2003, and the CIs were computerized in 2005 by implementing a DW-based CI monitoring system. We classified the computerized CIs and evaluated the monitoring results for several representative CIs, such as the optimal prescribing of preventive antibiotics, the average length of stay, the mortality rate, and the rehospitalization rate. During the development of the system in 2005, 12 of 19 CIs were computerized, and this number gradually increased until 299 of 335 CIs were computerized by 2012. In addition, among the CIs built computationally through the CI task force team, focal CIs subject to monitoring were selected annually, and the results of this monitoring were shared with all of the staff or the related department and its staff. By providing some examples of our CI monitoring results, we showed the feasibility of improving the quality of care, and maintaining the optimum level of patient care with less labor. The results of this study provide evidence regarding the clinical effectiveness and efficiency as well as the systems operation experience of a DW-based CI monitoring system. These findings may aid medical

  3. Patient-based not problem-based learning: An Oslerian approach to clinical skills, looking back to move forward

    Directory of Open Access Journals (Sweden)

    Franklyn-Miller A

    2009-01-01

    Full Text Available Context : There have been significant changes in the past decade in both the curriculum and its delivery, in undergraduate medical education. Many of these changes have been made simultaneously, preventing clear assessment of outcome measures. The move away from a pre-clinical science grounding, to an integrated ′problem-based learning (PBL approach′ has been widespread in many countries across the world. Purpose : One effect of these changes has been the way in which clinical skills, in particular history and examination are taught. By integrating clinical scenarios earlier in the undergraduate course, clinical skills are increasingly taught in tutorials. This approach, when used in the pre-clinical setting may have shortcomings in the development of the ability to construct a differential diagnosis. There has been little evidence that PBL improves problem-solving ability and this is critical to the differential diagnostic process. The concurrent decline in anatomical teaching and understanding contributes to this difficulty. Discussion : The authors outline a model which clinicians can re-emphasize to students and juniors based on the fundamentals of clinical practice. The apprenticeship is more important than ever in the days of small group learning. The relinquishing of the traditional model of undergraduate medicine is of concern. The effects of educational reform should be examined by further research into the competencies of graduates entering higher professional training, before it is accepted that this change has been for the better.

  4. Clinical Holistic Medicine: Tools for a Medical Science Based on Consciousness

    Directory of Open Access Journals (Sweden)

    Søren Ventegodt

    2004-01-01

    Full Text Available Biomedicine focuses on the biochemistry of the body, while consciousness-based medicine — holistic medicine — focuses on the individual's experiences and conscious whole (Greek: holos, whole. Biomedicine perceives diseases as mechanical errors at the micro level, while consciousness-based medicine perceives diseases as disturbances in attitudes, perceptions, and experiences at the macro level — in the organism as a whole. Thus, consciousness-based medicine is based on the whole individual, while biomedicine is based on its smallest parts, the molecules. These two completely different points of departure make the two forms of medicine very different; they represent two different mind sets and two different frames of reference or medical paradigms. This paper explains the basic tools of clinical holistic medicine based on the life mission theory and holistic process theory, with examples of holistic healing from the holistic medical clinic.

  5. Self-guided clinical cases for medical students based on postmortem CT scans of cadavers.

    Science.gov (United States)

    Bohl, Michael; Francois, Webster; Gest, Thomas

    2011-07-01

    In the summer of 2009, we began full body computed tomography (CT) scanning of the pre-embalmed cadavers in the University of Michigan Medical School (UMMS) dissection lab. We theorized that implementing web-based, self-guided clinical cases based on postmortem CT (PMCT) scans would result in increased student appreciation for the clinical relevance of anatomy, increased knowledge of cross-sectional anatomy, and increased ability to identify common pathologies on CT scans. The PMCT scan of each cadaver was produced as a DICOM dataset, and then converted into a Quicktime movie file using Osirix software. Clinical cases were researched and written by the authors, and consist of at least one Quicktime movie of a PMCT scan surrounded by a novel navigation interface. To assess the value of these clinical cases we surveyed medical students at UMMS who are currently using the clinical cases in their coursework. Students felt the clinical cases increased the clinical relevance of anatomy (mean response 7.77/10), increased their confidence finding anatomical structures on CT (7.00/10), and increased their confidence recognizing common pathologies on CT (6.17/10). Students also felt these clinical cases helped them synthesize material from numerous courses into an overall picture of a given disease process (7.01/10). These results support the conclusion that our clinical cases help to show students why the anatomy they are learning is foundational to their other coursework. We would recommend the use of similar clinical cases to any medical school utilizing cadaver dissection as a primary teaching method in anatomy education.

  6. Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization.

    Science.gov (United States)

    Hermiller, James; Simonton, Charles; Hinohara, Tom; Lee, Daniel; Cannon, Louis; Mooney, Michael; O'Shaughnessy, Charles; Carlson, Harold; Fortuna, Richard; Yarbrough, Carol Anne; Zapien, Michael; Chou, Tony

    2005-10-01

    The StarClose Vascular Closure System (Abbott Vascular Devices, Redwood City, California) utilizes a small, flexible nitinol clip to complete a circumferential, extravascular closure of the femoral arteriotomy site. The StarClose is an investigational device in the United States, limited by Federal law to investigational use. The StarClose is CE Mark approved. The CLIP study was a prospective, randomized, multicenter trial utilizing a noninferiority design to compare the rate of major vascular complications and time-to-hemostasis using the StarClose system versus manual compression. A total of 596 subjects were enrolled, 208 of whom underwent diagnostic angiography. This diagnostic subset is the focus of this report. The primary safety endpoint was major vascular complications and the primary efficacy endpoint was time-to-hemostasis. All patients were followed at 30 days with a clinical exam. Subjects were randomized 2:1 to the StarClose (n = 136) or manual compression (n = 72). There were no major vascular complications in either group. Minor vascular complications occurred in 3 StarClose patients (2.2%), and 1 manual compression patient (1.4%) (p = 1.00). Use of the StarClose device reduced mean time-to-hemostasis from 15.47 +/- 11.4 to 1.46 +/- 4.5 minutes (p manual compression, and reduced the average time-to-ambulation from 269 +/- 135 to 163 +/- 105 minutes (p < or = 0.001). Device success was 94.1% (127/135), and procedural success was 100% (136/136). The clinical results of this study concluded that the StarClose Vascular Closure System is noninferior to standard compression with respect to the the primary safety endpoint of closing arteriotomies in patients who undergo percutaneous diagnostic procedures.

  7. Realistic clinical practice: proposing an enquiry-based pedagogy for teacher education

    OpenAIRE

    Boyd, Pete; Cathedrals Group of Universities

    2017-01-01

    This chapter argues that teacher education in England, and more widely, should adopt an explicit pedagogy for initial teacher education programmes. A modified version of the clinical practice model is proposed and entitled 'realistic clinical practice'. This is an enquiry-based approach that builds the programme around the core practices of teachers. The approach insists that students teachers seek explanations of their impact on learning and on learners through enquiry informed by critical e...

  8. General practice-based clinical trials in Germany - a problem analysis

    Directory of Open Access Journals (Sweden)

    Hummers-Pradier Eva

    2012-11-01

    Full Text Available Abstract Background In Germany, clinical trials and comparative effectiveness studies in primary care are still very rare, while their usefulness has been recognised in many other countries. A network of researchers from German academic general practice has explored the reasons for this discrepancy. Methods Based on a comprehensive literature review and expert group discussions, problem analyses as well as structural and procedural prerequisites for a better implementation of clinical trials in German primary care are presented. Results In Germany, basic biomedical science and technology is more reputed than clinical or health services research. Clinical trials are funded by industry or a single national programme, which is highly competitive, specialist-dominated, exclusive of pilot studies, and usually favours innovation rather than comparative effectiveness studies. Academic general practice is still not fully implemented, and existing departments are small. Most general practitioners (GPs work in a market-based, competitive setting of small private practices, with a high case load. They have no protected time or funding for research, and mostly no research training or experience. Good Clinical Practice (GCP training is compulsory for participation in clinical trials. The group defined three work packages to be addressed regarding clinical trials in German general practice: (1 problem analysis, and definition of (2 structural prerequisites and (3 procedural prerequisites. Structural prerequisites comprise specific support facilities for general practice-based research networks that could provide practices with a point of contact. Procedural prerequisites consist, for example, of a summary of specific relevant key measures, for example on a web platform. The platform should contain standard operating procedures (SOPs, templates, checklists and other supporting materials for researchers. Conclusion All in all, our problem analyses revealed that

  9. 77 FR 8865 - Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval

    Science.gov (United States)

    2012-02-15

    ... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Public Water System Supervision Program Approval for the State of Illinois; Tentative Approval... State of Illinois submitted a primacy application for its approved Public Water System...

  10. Outcomes assessment of case-based writing exercises in a veterinary clinical pathology course.

    Science.gov (United States)

    Sharkey, Leslie; Michael, Helen; LeBeau, Brandon; Center, Bruce; Wingert, Deb

    2012-01-01

    Our second-year core clinical pathology course uses free-response case-based learning exercises in an otherwise traditional lecture or laboratory course format to augment the development of skills in application of knowledge and critical thinking and clinical reasoning. We previously reported increased learner confidence accompanied by perceived improvements in understanding and ability to apply information, along with enhanced feelings of preparedness for examinations that students attributed to the case-based exercises. The current study prospectively follows a cohort of students to determine the ability of traditional multiple-choice versus free-response case-based assessments to predict future academic performance and to determine if the perceived value of the case-based exercises persists through the curriculum. Our data show that after holding multiple-choice scores constant, better performance on case-based free-response exercises led to higher GPA and better class rank in the second and third years and better class rank in the fourth year. Students in clinical rotations reported that the case-based approach was superior to traditional lecture or multiple-choice exam format for learning clinical reasoning, retaining factual information, organizing information, communicating medical information clearly to colleagues in clinical situations, and preparing high quality medical records. In summary, this longitudinal study shows that case-based free-response writing assignments are efficacious above and beyond standard measures in determining students' GPAs and class rank and in students' acquisition of knowledge, skills, and clinical reasoning. Students value these assignments and overwhelmingly find them an efficient use of their time, and these opinions are maintained even two years following the course.

  11. Evaluating research for clinical significance: using critically appraised topics to enhance evidence-based neuropsychology.

    Science.gov (United States)

    Bowden, Stephen C; Harrison, Elise J; Loring, David W

    2014-01-01

    Meehl's (1973, Psychodiagnosis: Selected papers. Minneapolis: University of Minnesota Press) distinction between statistical and clinical significance holds special relevance for evidence-based neuropsychological practice. Meehl argued that despite attaining statistical significance, many published findings have limited practical value since they do not inform clinical care. In the context of an ever expanding clinical research literature, accessible methods to evaluate clinical impact are needed. The method of Critically Appraised Topics (Straus, Richardson, Glasziou, & Haynes, 2011, Evidence-based medicine: How to practice and teach EBM (4th ed.). Edinburgh: Elsevier Churchill-Livingstone) was developed to provide clinicians with a "toolkit" to facilitate implementation of evidence-based practice. We illustrate the Critically Appraised Topics method using a dementia screening example. We argue that the skills practiced through critical appraisal provide clinicians with methods to: (1) evaluate the clinical relevance of new or unfamiliar research findings with a focus on patient benefit, (2) help focus of research quality, and (3) incorporate evaluation of clinical impact into educational and professional development activities.

  12. Effect of citrus-based products on urine profile: A systematic review and meta-analysis [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Fakhri Rahman

    2017-03-01

    Full Text Available Background. Urolithiasis is a disease with high recurrence rate, 30-50% within 5 years. The aim of the present study was to learn the effects of citrus-based products on the urine profile in healthy persons and people with urolithiasis compared to control diet and potassium citrate. Methods. A systematic review was performed, which included interventional, prospective observational and retrospective studies, comparing citrus-based therapy with standard diet therapy, mineral water, or potassium citrate. A literature search was conducted using PUBMED, COCHRANE, and Google Scholar with “citrus or lemonade or orange or grapefruit or lime or juice” and “urolithiasis” as search terms. For statistical analysis, a fixed-effects model was conducted when p > 0.05, and random-effects model was conducted when p < 0.05. Results. In total, 135 citations were found through database searching with 10 studies found to be consistent with our selection criteria. However, only 8 studies were included in quantitative analysis, due to data availability. The present study showed a higher increased in urine pH for citrus-based products (mean difference, 0.16; 95% CI 0.01-0.32 and urinary citrate (mean difference, 124.49; 95% CI 80.24-168.74 compared with a control group. However, no differences were found in urine volume, urinary calcium, urinary oxalate, and urinary uric acid. From subgroup analysis, we found that citrus-based products consistently increased urinary citrate level higher than controls in both healthy and urolithiasis populations. Furthermore, there was lower urinary calcium level among people with urolithiasis. Conclusions. Citrus-based products could increase urinary citrate level significantly higher than control. These results should encourage further research to explore citrus-based products as a urolithiasis treatment.

  13. Practice-based evidence: profiling the safety of cilostazol by text-mining of clinical notes.

    Directory of Open Access Journals (Sweden)

    Nicholas J Leeper

    Full Text Available BACKGROUND: Peripheral arterial disease (PAD is a growing problem with few available therapies. Cilostazol is the only FDA-approved medication with a class I indication for intermittent claudication, but carries a black box warning due to concerns for increased cardiovascular mortality. To assess the validity of this black box warning, we employed a novel text-analytics pipeline to quantify the adverse events associated with Cilostazol use in a clinical setting, including patients with congestive heart failure (CHF. METHODS AND RESULTS: We analyzed the electronic medical records of 1.8 million subjects from the Stanford clinical data warehouse spanning 18 years using a novel text-mining/statistical analytics pipeline. We identified 232 PAD patients taking Cilostazol and created a control group of 1,160 PAD patients not taking this drug using 1:5 propensity-score matching. Over a mean follow up of 4.2 years, we observed no association between Cilostazol use and any major adverse cardiovascular event including stroke (OR = 1.13, CI [0.82, 1.55], myocardial infarction (OR = 1.00, CI [0.71, 1.39], or death (OR = 0.86, CI [0.63, 1.18]. Cilostazol was not associated with an increase in any arrhythmic complication. We also identified a subset of CHF patients who were prescribed Cilostazol despite its black box warning, and found that it did not increase mortality in this high-risk group of patients. CONCLUSIONS: This proof of principle study shows the potential of text-analytics to mine clinical data warehouses to uncover 'natural experiments' such as the use of Cilostazol in CHF patients. We envision this method will have broad applications for examining difficult to test clinical hypotheses and to aid in post-marketing drug safety surveillance. Moreover, our observations argue for a prospective study to examine the validity of a drug safety warning that may be unnecessarily limiting the use of an efficacious therapy.

  14. Implementing ward based clinical pharmacy services in an Ethiopian University Hospital

    Directory of Open Access Journals (Sweden)

    Mekonnen AB

    2013-03-01

    Full Text Available Background: Clinical pharmacy practice has developed internationally to expand the role of a pharmacist well beyond the traditional roles of compounding, dispensing and supplying drugs to roles more directly in caring for patients. Studies on the activities of the clinical pharmacist in an inpatient ward in resource constrained settings are scarce, however.Objective: To assess ward based clinical pharmacy services in an internal medicine ward of Jimma University Specialized Hospital. Methods: The study was carried out in the internal medicine ward from March to April, 2011 at Jimma University Specialized Hospital. The study design was a prospective observational study where pharmaceutical care services provided by clinical pharmacists for inpatients were documented over a period of two months. Interventions like optimization of rational drug use and physician acceptance of these recommendations were documented. Clinical significance of interventions was evaluated by an independent team (1 internist, 1 clinical pharmacologist using a standardized method for categorizing drug related problems (DRPs. Results: A total of 149 drug related interventions conducted for 48 patients were documented; among which 133(89.3% were clinical pharmacists initiated interventions and 16(10.7% interventions were initiated by other health care professionals. The most frequent DRPs underlying interventions were unnecessary drug therapy, 36(24.2%; needs additional drug therapy, 34(22.8% and noncompliance, 29(19.5%. The most frequent intervention type was change of dosage/instruction for use, 23(15.4%. Acceptance rate by physicians was 68.4%. Among the interventions that were rated as clinically significant, 46(48.9% and 25(26.6% had major and moderate clinical importance respectively. Conclusion: Involving trained clinical pharmacists in the healthcare team leads to clinically relevant and well accepted optimization of medicine use in a resource limited settings. This

  15. Drug approval and surveillance.

    Science.gov (United States)

    Potts, M

    1980-01-01

    This article argues that current regulations governing the licensing of drugs, particularly in the U.S., need to be changed and replaced by a system of provisional or conditional licensing and increased postmarketing surveillance of drug use. In terms of research and development of new forms of contraception, this proposal would have great impact. It is believed that the U.S./Food and Drug Administration (FDA) requirements--animal experiments and Phase 1 and 2 clinical trials--not only put an unacceptable financial burden on any institution attempting to develop new contraceptives, but do not demonstrably contribute to the reduction of risks. The author questions whether even if oral contraceptives introduced prior to new U.S./FDA regulations had been subject to these current regulations that convincing evidence would have been found to alert anyone to the now-known rare adverse effects, such as risk of thromboembolism. It is pointed out that these sorts of rare risks were uncovered by continuous screening processes which are not now a part of the FDA drug regulation requirements. The author also questions the politics of "conpulsory safety," such as might be legislated for regulated car safety belt use. Citing a partnership already established between government and private industry in high-risk/low cost ventures in the aerospace industry, the author sees no reason why such a relationship could not evolve in the pharmaceutical industry. In Britain, proposals have been made to establish a fund to compensate patients adversely affected by drugs which pharmaceutical companies would reimburse if proved negligent; such a fund may work in the U.S. under new regulations which stress postmarketing surveillance.

  16. Medical imaging in clinical applications algorithmic and computer-based approaches

    CERN Document Server

    Bhateja, Vikrant; Hassanien, Aboul

    2016-01-01

    This volume comprises of 21 selected chapters, including two overview chapters devoted to abdominal imaging in clinical applications supported computer aided diagnosis approaches as well as different techniques for solving the pectoral muscle extraction problem in the preprocessing part of the CAD systems for detecting breast cancer in its early stage using digital mammograms. The aim of this book is to stimulate further research in medical imaging applications based algorithmic and computer based approaches and utilize them in real-world clinical applications. The book is divided into four parts, Part-I: Clinical Applications of Medical Imaging, Part-II: Classification and clustering, Part-III: Computer Aided Diagnosis (CAD) Tools and Case Studies and Part-IV: Bio-inspiring based Computer Aided diagnosis techniques. .

  17. Model-based control of mechanical ventilation: design and clinical validation.

    Science.gov (United States)

    Martinoni, E P; Pfister, Ch A; Stadler, K S; Schumacher, P M; Leibundgut, D; Bouillon, T; Böhlen, T; Zbinden, A M

    2004-06-01

    We developed a model-based control system using end-tidal carbon dioxide fraction (FE'(CO(2))) to adjust a ventilator during clinical anaesthesia. We studied 16 ASA I-II patients (mean age 38 (range 20-59) yr; weight 67 (54-87) kg) during i.v. anaesthesia for elective surgery. After periods of normal ventilation the patients were either hyper- or hypoventilated to assess precision and dynamic behaviour of the control system. These data were compared with a previous group where a fuzzy-logic controller had been used. Responses to different clinical events (invalid carbon dioxide measurement, limb tourniquet release, tube cuff leak, exhaustion of carbon dioxide absorbent, simulation of pulmonary embolism) were also noted. The model-based controller correctly maintained the setpoint. No significant difference was found for the static performance between the two controllers. The dynamic response of the model-based controller was more rapid (Pfuzzy-logic and model-based control, respectively, and after a 1 vol% decrease was 355 (127) s and 177 (36) s, respectively. The new model-based controller had a consistent response to clinical artefacts. A model-based FE'(CO(2)) controller can be used in a clinical setting. It reacts appropriately to artefacts, and has a better dynamic response to setpoint changes than a previously described fuzzy-logic controller.

  18. IOM Review of FDA--approved biologics labeled or studied for pediatric use.

    Science.gov (United States)

    Field, Marilyn J; Ellinger, Lara K; Boat, Thomas F

    2013-02-01

    Studies have examined the extent to which public policies such as the Best Pharmaceuticals for Children Act have increased pediatric information in drug labeling. Little attention has focused on pediatric labeling of biologics. This analysis examines the extent to which biologics are labeled for pediatric use or have been studied in children. The analysis covers the 96 biologics (excluding vaccines) that were first licensed by the Food and Drug Administration between 1997 and 2010 and were still marketed as of 2010. Product labeling was consulted for information on approved pediatric uses, pediatric studies, or pediatric safety warnings based on analyses of adverse events. The online database ClinicalTrials.gov was searched for registered pediatric studies of these biologics. A separate analysis examined labeling and studies for 55 vaccines. For ∼60% of the 96 biologics, labeling shows approved pediatric use or pediatric study information or both. Approximately 85% of the biologics have ≥1 registered pediatric trial completed, underway, or planned. Overall, ∼90% are labeled for pediatric use, have pediatric information in the label, have a registered pediatric study, or have some combination of these characteristics. For the 55 analyzed vaccines, the corresponding figure is 95%. A majority of biologics approved in the past 15 years include some pediatric information in their labeling, and pediatric trials have been registered for a substantial majority of these products.

  19. Alkylbenzene Project in Xinjiang Approved

    Institute of Scientific and Technical Information of China (English)

    Zhou Weiyong

    1996-01-01

    @@ The feasibility study on alkylbenzene project in Dushanzi, Xinjiang Uygur Autonomous Region, submitted jointly by the government of Xinjiang UygurAutonomous Region and China National Petroleum Corporation (CNPC), has been approved by State Council recently,after pass appraisa l by China International Engineering Consulting Corporation entrusted by State Planning Committee.

  20. Drugs Approved for Multiple Myeloma

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for multiple myeloma and other plasma cell neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  1. Drugs Approved for Myeloproliferative Neoplasms

    Science.gov (United States)

    This page lists cancer drugs approved by the Food and Drug Administration (FDA) for myeloproliferative neoplasms. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. The drug names link to NCI's Cancer Drug Information summaries.

  2. Perceived Benefits of Pre-Clinical Simulation-based Training on Clinical Learning Outcomes among Omani Undergraduate Nursing Students

    Directory of Open Access Journals (Sweden)

    Girija Madhavanprabhakaran

    2015-01-01

    Full Text Available Objectives: This study aimed to explore the benefits perceived by Omani undergraduate maternity nursing students regarding the effect of pre-clinical simulation-based training (PSBT on clinical learning outcomes. Methods: This non-experimental quantitative survey was conducted between August and December 2012 among third-year baccalaureate nursing students at Sultan Qaboos University in Muscat, Oman. Voluntary participants were exposed to faculty-guided PSBT sessions using low- and medium-fidelity manikins, standardised scenarios and skill checklists on antenatal, intranatal, postnatal and newborn care and assessment. Participants answered a purposely designed self-administered questionnaire on the benefits of PSBT in enhancing learning outcomes. Items were categorised into six subscales: knowledge, skills, patient safety, academic safety, confidence and satisfaction. Scores were rated on a four-point Likert scale. Results: Of the 57 participants, the majority (95.2% agreed that PSBT enhanced their knowledge. Most students (94.3% felt that their patient safety practices improved and 86.5% rated PSBT as beneficial for enhancing skill competencies. All male students and 97% of the female students agreed that PSBT enhanced their confidence in the safe holding of newborns. Moreover, 93% of participants were satisfied with PSBT. Conclusion: Omani undergraduate nursing students perceived that PSBT enhanced their knowledge, skills, patient safety practices and confidence levels in providing maternity care. These findings support the use of simulation training as a strategy to facilitate clinical learning outcomes in future nursing courses in Oman, although further research is needed to explore the objective impact of PSBT on learning outcomes.

  3. Gene therapy for cancer: regulatory considerations for approval.

    Science.gov (United States)

    Husain, S R; Han, J; Au, P; Shannon, K; Puri, R K

    2015-12-01

    The rapidly changing field of gene therapy promises a number of innovative treatments for cancer patients. Advances in genetic modification of cancer and immune cells and the use of oncolytic viruses and bacteria have led to numerous clinical trials for cancer therapy, with several progressing to late-stage product development. At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration (FDA). Some of the key scientific and regulatory issues include understanding of gene transfer vector biology, safety of vectors in vitro and in animal models, optimum gene transfer, long-term persistence or integration in the host, shedding of a virus and ability to maintain transgene expression in vivo for a desired period of time. Because of the biological complexity of these products, the FDA encourages a flexible, data-driven approach for preclinical safety testing programs. The clinical trial design should be based on the unique features of gene therapy products, and should ensure the safety of enrolled subjects. This article focuses on regulatory considerations for gene therapy product development and also discusses guidance documents that have been published by the FDA.

  4. Shareholders, creditors approve utility reorganization plan

    Energy Technology Data Exchange (ETDEWEB)

    1990-04-12

    Shareholders and all classes of secured creditors of Public Service Company of New Hampshire voted overwhelmingly last month to approve Northeast Utilities' Chapter 11 reorganization plan for PSNH, the utility announced. PSNH filed for bankruptcy protection in January 1988. Under the reorganization plan, Connecticut-based NU would acquire the utility for $2.3 billion. While PSNH's preferred and common stockholders voted to accept the proposal, holders of warrants to purchase PSNH common stock rejected the plan. Except for the votes of a group of independent power producers, PSNH's unsecured creditors also voted to accept the plan.

  5. Case-based lung image categorization and retrieval for interstitial lung diseases: clinical workflows.

    Science.gov (United States)

    Depeursinge, Adrien; Vargas, Alejandro; Gaillard, Frédéric; Platon, Alexandra; Geissbuhler, Antoine; Poletti, Pierre-Alexandre; Müller, Henning

    2012-01-01

    Clinical workflows and user interfaces of image-based computer-aided diagnosis (CAD) for interstitial lung diseases in high-resolution computed tomography are introduced and discussed. Three use cases are implemented to assist students, radiologists, and physicians in the diagnosis workup of interstitial lung diseases. In a first step, the proposed system shows a three-dimensional map of categorized lung tissue patterns with quantification of the diseases based on texture analysis of the lung parenchyma. Then, based on the proportions of abnormal and normal lung tissue as well as clinical data of the patients, retrieval of similar cases is enabled using a multimodal distance aggregating content-based image retrieval (CBIR) and text-based information search. The global system leads to a hybrid detection-CBIR-based CAD, where detection-based and CBIR-based CAD show to be complementary both on the user's side and on the algorithmic side. The proposed approach is in accordance with the classical workflow of clinicians searching for similar cases in textbooks and personal collections. The developed system enables objective and customizable inter-case similarity assessment, and the performance measures obtained with a leave-one-patient-out cross-validation (LOPO CV) are representative of a clinical usage of the system.

  6. Clinical Study on the Visceral Differentiation-Based Acupuncture Therapy for Insomnia

    Institute of Scientific and Technical Information of China (English)

    LING Li; JIANG Xin-mei; XUE Jin-wei; WANG Miao; KE Rui

    2008-01-01

    objective;To investigate the clinical effects of acupuncture for insomnia on the basis of visceral differentiation.Methods;Seventy cases of insomnia were randomly divided into a treatment group and a control group,The former was treated by acupuncture based on visceral differentiation and the latter by the routine acupuncture therapy.Results;The clinical effcts were significantly better in the treatment group than that of the control group(P<0.05).Conclusion;The visceral difrerentiation-based acupuncture therapy may enhance the therapeutic effects for insomnia patients.

  7. NMR-based metabolomics of prostate cancer: a protagonist in clinical diagnostics.

    Science.gov (United States)

    Kumar, Deepak; Gupta, Ashish; Nath, Kavindra

    2016-06-01

    Advances in the application of NMR spectroscopy-based metabolomic profiling of prostate cancer comprises a potential tactic for understanding the impaired biochemical pathways arising due to a disease evolvement and progression. This technique involves qualitative and quantitative estimation of plethora of small molecular weight metabolites of body fluids or tissues using state-of-the-art chemometric methods delivering an important platform for translational research from basic to clinical, to reveal the pathophysiological snapshot in a single step. This review summarizes the present arrays and recent advancements in NMR-based metabolomics and a glimpse of currently used medical imaging tactics, with their role in clinical diagnosis of prostate cancer.

  8. A CRISPR/Cas9-based method and primer design tool for seamless genome editing in fission yeast [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    María Rodríguez-López

    2017-01-01

    Full Text Available In the fission yeast Schizosaccharomyces pombe the prevailing approach for gene manipulations is based on homologous recombination of a PCR product that contains genomic target sequences and a selectable marker. The CRISPR/Cas9 system has recently been implemented in fission yeast, which allows for seamless genome editing without integration of a selection marker or leaving any other genomic ‘scars’. The published method involves manual design of the single guide RNA (sgRNA, and digestion of a large plasmid with a problematic restriction enzyme to clone the sgRNA. To increase the efficiency of this approach, we have established and optimized a PCR-based system to clone the sgRNA without restriction enzymes into a plasmid with a dominant natMX6 (nourseothricin selection marker. We also provide a web-tool, CRISPR4P, to support the design of the sgRNAs and the primers required for the entire process of seamless DNA deletion. Moreover, we report the preparation of G1-synchronized and cryopreserved S. pombe cells, which greatly increases the efficiency and speed for transformations, and may also facilitate standard gene manipulations. Applying this optimized CRISPR/Cas9-based approach, we have successfully deleted over 80 different non-coding RNA genes, which are generally lowly expressed, and have inserted 7 point mutations in 4 different genomic regions.

  9. A CRISPR/Cas9-based method and primer design tool for seamless genome editing in fission yeast [version 3; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    María Rodríguez-López

    2017-05-01

    Full Text Available In the fission yeast Schizosaccharomyces pombe the prevailing approach for gene manipulations is based on homologous recombination of a PCR product that contains genomic target sequences and a selectable marker. The CRISPR/Cas9 system has recently been implemented in fission yeast, which allows for seamless genome editing without integration of a selection marker or leaving any other genomic ‘scars’. The published method involves manual design of the single guide RNA (sgRNA, and digestion of a large plasmid with a problematic restriction enzyme to clone the sgRNA. To increase the efficiency of this approach, we have established and optimized a PCR-based system to clone the sgRNA without restriction enzymes into a plasmid with a dominant natMX6 (nourseothricin selection marker. We also provide a web-tool, CRISPR4P, to support the design of the sgRNAs and the primers required for the entire process of seamless DNA deletion. Moreover, we report the preparation of G1-synchronized and cryopreserved S. pombe cells, which greatly increases the efficiency and speed for transformations, and may also facilitate standard gene manipulations. Applying this optimized CRISPR/Cas9-based approach, we have successfully deleted over 80 different non-coding RNA genes, which are generally lowly expressed, and have inserted 7 point mutations in 4 different genomic regions.

  10. Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials.

    Science.gov (United States)

    Meropol, Neal J; Wong, Yu-Ning; Albrecht, Terrance; Manne, Sharon; Miller, Suzanne M; Flamm, Anne Lederman; Benson, Al Bowen; Buzaglo, Joanne; Collins, Michael; Egleston, Brian; Fleisher, Linda; Katz, Michael; Kinzy, Tyler G; Liu, Tasnuva M; Margevicius, Seunghee; Miller, Dawn M; Poole, David; Roach, Nancy; Ross, Eric; Schluchter, Mark D

    2016-02-10

    Lack of knowledge and negative attitudes have been identified as barriers to participation in clinical trials by patients with cancer. We developed Preparatory Education About Clinical Trials (PRE-ACT), a theory-guided, Web-based, interactive computer program, to deliver tailored video educational content to patients in an effort to overcome barriers to considering clinical trials as a treatment option. A prospective, randomized clinical trial compared PRE-ACT with a control condition that provided general clinical trials information produced by the National Cancer Institute (NCI) in text format. One thousand two hundred fifty-five patients with cancer were randomly allocated before their initial visit with an oncologist to PRE-ACT (n = 623) or control (n = 632). PRE-ACT had three main components: assessment of clinical trials knowledge and attitudinal barriers, values assessment with clarification back to patients, and provision of a video library tailored to address each patient's barriers. Outcomes included knowledge and attitudes and preparation for decision making about clinical trials. Both PRE-ACT and control interventions improved knowledge and attitudes (all P < .001) compared with baseline. Patients randomly allocated to PRE-ACT showed a significantly greater increase in knowledge (P < .001) and a significantly greater decrease in attitudinal barriers (P < .001) than did their control (text-only) counterparts. Participants in both arms significantly increased their preparedness to consider clinical trials (P < .001), and there was a trend favoring the PRE-ACT group (P < .09). PRE-ACT was also associated with greater patient satisfaction than was NCI text alone. These data show that patient education before the first oncologist visit improves knowledge, attitudes, and preparation for decision making about clinical trials. Both text and tailored video were effective. The PRE-ACT interactive video program was more effective than NCI text in improving

  11. CE: Original Research: Creating an Evidence-Based Progression for Clinical Advancement Programs.

    Science.gov (United States)

    Burke, Kathleen G; Johnson, Tonya; Sites, Christine; Barnsteiner, Jane

    2017-05-01

    : Background: The Institute of Medicine (IOM) and the Quality and Safety Education for Nurses (QSEN) project have identified six nursing competencies and supported their integration into undergraduate and graduate nursing curricula nationwide. But integration of those competencies into clinical practice has been limited, and evidence for the progression of competency proficiency within clinical advancement programs is scant. Using an evidence-based approach and building on the competencies identified by the IOM and QSEN, a team of experts at an academic health system developed eight competency domains and 186 related knowledge, skills, and attitudes (KSAs) for professional nursing practice. The aim of our study was to validate the eight identified competencies and 186 related KSAs and determine their developmental progression within a clinical advancement program. Using the Delphi technique, nursing leadership validated the newly identified competency domains and KSAs as essential to practice. Clinical experts from 13 Magnet-designated hospitals with clinical advancement programs then participated in Delphi rounds aimed at reaching consensus on the developmental progression of the 186 KSAs through four levels of clinical advancement. Two Delphi rounds resulted in consensus by the expert participants. All eight competency domains were determined to be essential at all four levels of clinical practice. At the novice level of practice, the experts identified a greater number of KSAs in the domains of safety and patient- and family-centered care. At more advanced practice levels, the experts identified a greater number of KSAs in the domains of professionalism, teamwork, technology and informatics, and continuous quality improvement. Incorporating the eight competency domains and the 186 KSAs into a framework for clinical advancement programs will likely result in more clearly defined role expectations; enhance accountability; and elevate and promote nursing practice

  12. Advancing the Scientific Foundation for Evidence-Based Practice in Clinical Child and Adolescent Psychology.

    Science.gov (United States)

    Roberts, Michael C; Blossom, Jennifer B; Evans, Spencer C; Amaro, Christina M; Kanine, Rebecca M

    2016-05-24

    Evidence-based practice (EBP) has become a central focus in clinical child and adolescent psychology. As originally defined, EBP in psychology is the integration of the best available research evidence, patient characteristics, and clinical expertise. Although evidence-based perspectives have garnered widespread acceptance in recent years, there has also been some confusion and disagreement about the 3-part definition of EBP, particularly the role of research. In this article, we first provide a brief review of the development of EBP in clinical child and adolescent psychology. Next, we outline the following 4 points to help clarify the understanding of EBP: (a) knowledge should not be confused with epistemic processes, (b) research on clinician and client factors is needed for EBP, (c) research on assessment is needed for EBP, and (d) the 3-part conceptualization of EBP can serve as a useful framework to guide research. Based on these principles, we put forth a slightly revised conceptualization of EBP, in which the role of research is expanded and more clearly operationalized. Finally, based on our review of the literature, we offer illustrative examples of specific directions for future research to advance the evidence base for EBP in clinical child and adolescent psychology.

  13. Clinical-decision support based on medical literature: A complex network approach

    Science.gov (United States)

    Jiang, Jingchi; Zheng, Jichuan; Zhao, Chao; Su, Jia; Guan, Yi; Yu, Qiubin

    2016-10-01

    In making clinical decisions, clinicians often review medical literature to ensure the reliability of diagnosis, test, and treatment because the medical literature can answer clinical questions and assist clinicians making clinical decisions. Therefore, finding the appropriate literature is a critical problem for clinical-decision support (CDS). First, the present study employs search engines to retrieve relevant literature about patient records. However, the result of the traditional method is usually unsatisfactory. To improve the relevance of the retrieval result, a medical literature network (MLN) based on these retrieved papers is constructed. Then, we show that this MLN has small-world and scale-free properties of a complex network. According to the structural characteristics of the MLN, we adopt two methods to further identify the potential relevant literature in addition to the retrieved literature. By integrating these potential papers into the MLN, a more comprehensive MLN is built to answer the question of actual patient records. Furthermore, we propose a re-ranking model to sort all papers by relevance. We experimentally find that the re-ranking model can improve the normalized discounted cumulative gain of the results. As participants of the Text Retrieval Conference 2015, our clinical-decision method based on the MLN also yields higher scores than the medians in most topics and achieves the best scores for topics: #11 and #12. These research results indicate that our study can be used to effectively assist clinicians in making clinical decisions, and the MLN can facilitate the investigation of CDS.

  14. Clinical pharmacokinetic/pharmacodynamic and physiologically based pharmacokinetic modeling in new drug development: the capecitabine experience.

    Science.gov (United States)

    Blesch, Karen S; Gieschke, Ronald; Tsukamoto, Yuko; Reigner, Bruno G; Burger, Hans U; Steimer, Jean-Louis

    2003-05-01

    Preclinical studies, along with Phase I, II, and III clinical trials demonstrate the pharmacokinetics, pharmacodynamics, safety and efficacy of a new drug under well controlled circumstances in relatively homogeneous populations. However, these types of studies generally do not answer important questions about variability in specific factors that predict pharmacokinetic and pharmacodynamic (PKPD) activity, in turn affecting safety and efficacy. Semi-physiological and clinical PKPD modeling and simulation offer the possibility of utilizing data obtained in the laboratory and the clinic to make accurate characterizations and predictions of PKPD activity in the target population, based on variability in predictive factors. Capecitabine is an orally administered pro-drug of 5-fluorouracil (5-FU), designed to exploit tissue-specific differences in metabolic enzyme activities in order to enhance efficacy and safety. It undergoes extensive metabolism in multiple physiologic compartments, and presents particular challenges for predicting pharmacokinetic and pharmacodynamic activity in humans. Clinical and physiologically based pharmacokinetic (PBPK) and pharmacodynamic models were developed to characterize the activity of capecitabine and its metabolites, and the clinical consequences under varying physiological conditions such as creatinine clearance or activity of key metabolic enzymes. The results of the modeling investigations were consistent with capecitabine's rational design as a triple pro-drug of 5-FU. This paper reviews and discusses the PKPD and PBPK modeling approaches used in capecitabine development to provide a more thorough understanding of what the key predictors of its PBPK activity are, and how variability in these predictors may affect its PKPD, and ultimately, clinical outcomes.

  15. A home-based comprehensive care model in patients with Multiple Sclerosis: A study pre-protocol [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Lufei Young

    2015-09-01

    Full Text Available Background Disability is prevalent in individuals with multiple sclerosis (MS, leading to difficulty in care access, significant caregiver burden, immense challenges in self-care and great societal burden.  Without highly coordinated, competent and accessible care, individuals living with progressive MS experience psychological distress, poor quality of life, suffer from life-threatening complications, and have frequent but avoidable healthcare utilizations. Unfortunately, current healthcare delivery models present severe limitations in providing easily accessible, patient-centered, coordinated comprehensive care to those with progressive MS. We propose a home-based comprehensive care model (MAHA to address the unmet needs, challenges, and avoidable complications in individuals with progressive MS with disabling disease. Objective The article aims to describe the study design and methods used to implement and evaluate the proposed intervention.   Method The study will use a randomized controlled design to evaluate the feasibility of providing a 24-month, home-based, patient-centered comprehensive care program to improve quality of life, reduce complications and healthcare utilizations overtime (quarterly for 24 months. A transdisciplinary team led by a MS-Comprehensivist will carry out this project. Fifty MS patients will be randomly assigned to the intervention and usual care program using block randomization procedures. We hypothesize that patients in the intervention group will have fewer complications, higher quality of life, greater satisfaction with care, and reduced healthcare utilization. The proposed project is also expected to be financially sustainable in fee-for-service models but best suited for and gain financial success in valued-based care systems.   Discussion This is the first study to examine the feasibility and effectiveness of a home-based comprehensive care management program in MS patients living with progressive

  16. A citation-based, author- and age-normalized, logarithmic index for evaluation of individual researchers independently of publication counts [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Aleksey V. Belikov

    2015-09-01

    Full Text Available The use of citation metrics for evaluation of individual researchers has dramatically increased over the last decade. However, currently existing indices either are based on misleading premises or are cumbersome to implement. This leads to poor assessment of researchers and creates dangerous trends in science, such as overproduction of low quality articles. Here we propose an index (namely, the L-index that does not depend on the number of publications, accounts for different co-author contributions and age of publications, and scales from 0.0 to 9.9. Moreover, it can be calculated with the help of freely available software.

  17. Effects of additional team-based learning on students' clinical reasoning skills: a pilot study.

    Science.gov (United States)

    Jost, Meike; Brüstle, Peter; Giesler, Marianne; Rijntjes, Michel; Brich, Jochen

    2017-07-14

    In the field of Neurology good clinical reasoning skills are essential for successful diagnosing and treatment. Team-based learning (TBL), an active learning and small group instructional strategy, is a promising method for fostering these skills. The aim of this pilot study was to examine the effects of a supplementary TBL-class on students' clinical decision-making skills. Fourth- and fifth-year medical students participated in this pilot study (static-group comparison design). The non-treatment group (n = 15) did not receive any additional training beyond regular teaching in the neurology course. The treatment group (n = 11) took part in a supplementary TBL-class optimized for teaching clinical reasoning in addition to the regular teaching in the neurology course. Clinical decision making skills were assessed using a key-feature problem examination. Factual and conceptual knowledge was assessed by a multiple-choice question examination. The TBL-group performed significantly better than the non-TBL-group (p = 0.026) in the key-feature problem examination. No significant differences between the results of the multiple-choice question examination of both groups were found. In this pilot study participants of a supplementary TBL-class significantly improved clinical decision-making skills, indicating that TBL may be an appropriate method for teaching clinical decision making in neurology. Further research is needed for replication in larger groups and other clinical fields.

  18. Training-Based Interventions in Motor Rehabilitation after Stroke: Theoretical and Clinical Considerations

    Directory of Open Access Journals (Sweden)

    Annette Sterr

    2004-01-01

    Full Text Available Basic neuroscience research on brain plasticity, motor learning and recovery has stimulated new concepts in neurological rehabilitation. Combined with the development of set methodological standards in clinical outcome research, these findings have led to a double-paradigm shift in motor rehabilitation: (a the move towards evidence-based procedures for the assessment of clinical outcome & the employment of disablement models to anchor outcome parameters, and (b the introduction of practice-based concepts that are derived from testable models that specify treatment mechanisms. In this context, constraint-induced movement therapy (CIT has played a catalytic role in taking motor rehabilitation forward into the scientific arena. As a theoretically founded and hypothesis-driven intervention, CIT research focuses on two main issues. The first issue is the assessment of long-term clinical benefits in an increasing range of patient groups, and the second issue is the investigation of neuronal and behavioural treatment mechanisms and their interactive contribution to treatment success. These studies are mainly conducted in the research environment and will eventually lead to increased treatment benefits for patients in standard health care. However, gradual but presumably more immediate benefits for patients may be achieved by introducing and testing derivates of the CIT concept that are more compatible with current clinical practice. Here, we summarize the theoretical and empirical issues related to the translation of research-based CIT work into the clinical context of standard health care.

  19. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report.

    Science.gov (United States)

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-09-27

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research.

  20. Ethical issues and best practice in clinically based genomic research: Exeter Stakeholders Meeting Report

    Science.gov (United States)

    Carrieri, D; Bewshea, C; Walker, G; Ahmad, T; Bowen, W; Hall, A; Kelly, S

    2016-01-01

    Current guidelines on consenting individuals to participate in genomic research are diverse. This creates problems for participants and also for researchers, particularly for clinicians who provide both clinical care and research to their patients. A group of 14 stakeholders met on 7 October 2015 in Exeter to discuss the ethical issues and the best practice arising in clinically based genomic research, with particular emphasis on the issue of returning results to study participants/patients in light of research findings affecting research and clinical practices. The group was deliberately multidisciplinary to ensure that a diversity of views was represented. This report outlines the main ethical issues, areas of best practice and principles underlying ethical clinically based genomic research discussed during the meeting. The main point emerging from the discussion is that ethical principles, rather than being formulaic, should guide researchers/clinicians to identify who the main stakeholders are to consult with for a specific project and to incorporate their voices/views strategically throughout the lifecycle of each project. We believe that the mix of principles and practical guidelines outlined in this report can contribute to current debates on how to conduct ethical clinically based genomic research. PMID:27677925

  1. Developing a competency-based educational structure within clinical and translational science.

    Science.gov (United States)

    Dilmore, Terri Collin; Moore, Debra W; Bjork, Zuleikha

    2013-04-01

    In the emerging field of clinical and translational science (CTS), where researchers use both basic and clinical science research methodologies to move discoveries to clinical practice, establishing standards of competence is essential for preparing physician-scientists for the profession and for defining the field. The diversity of skills needed to execute quality research within the field of CTS has heightened the importance of an educational process that requires learners to demonstrate competence. Particularly within the more applied clinical science disciplines where there is a multi- or interdisciplinary approach to conducting research, defining and articulating the unique role and associated competencies of a physician-scientist is necessary. This paper describes a systematic process for developing a competency-based educational framework within a CTS graduate program at one institution.

  2. 45 CFR 1326.21 - Application approval.

    Science.gov (United States)

    2010-10-01

    ..., DEPARTMENT OF HEALTH AND HUMAN SERVICES THE ADMINISTRATION ON AGING, OLDER AMERICANS PROGRAMS GRANTS TO INDIAN TRIBES FOR SUPPORT AND NUTRITION SERVICES § 1326.21 Application approval. (a) Approval of any...

  3. Developing evidence-based dentistry skills: how to interpret randomized clinical trials and systematic reviews.

    Science.gov (United States)

    Kiriakou, Juliana; Pandis, Nikolaos; Madianos, Phoebus; Polychronopoulou, Argy

    2014-10-30

    Decision-making based on reliable evidence is more likely to lead to effective and efficient treatments. Evidence-based dentistry was developed, similarly to evidence-based medicine, to help clinicians apply current and valid research findings into their own clinical practice. Interpreting and appraising the literature is fundamental and involves the development of evidence-based dentistry (EBD) skills. Systematic reviews (SRs) of randomized controlled trials (RCTs) are considered to be evidence of the highest level in evaluating the effectiveness of interventions. Furthermore, the assessment of the report of a RCT, as well as a SR, can lead to an estimation of how the study was designed and conducted.

  4. Mobile Clinical Decision Support System for Acid-base Balance Diagnosis and Treatment Recommendation.

    Science.gov (United States)

    Mandzuka, Mensur; Begic, Edin; Boskovic, Dusanka; Begic, Zijo; Masic, Izet

    2017-06-01

    This paper presents mobile application implementing a decision support system for acid-base disorder diagnosis and treatment recommendation. The application was developed using the official integrated development environment for the Android platform (to maximize availability and minimize investments in specialized hardware) called Android Studio. The application identifies disorder, based on the blood gas analysis, evaluates whether the disorder has been compensated, and based on additional input related to electrolyte imbalance, provides recommendations for treatment. The application is a tool in the hands of the user, which provides assistance during acid-base disorders treatment. The application will assist the physician in clinical practice and is focused on the treatment in intensive care.

  5. Evaluation of quantitative accuracy in CZT-based pre-clinical SPECT for various isotopes

    Science.gov (United States)

    Park, S.-J.; Yu, A. R.; Kim, Y.-s.; Kang, W.-S.; Jin, S. S.; Kim, J.-S.; Son, T. J.; Kim, H.-J.

    2015-05-01

    In vivo pre-clinical single-photon emission computed tomography (SPECT) is a valuable tool for functional small animal imaging, but several physical factors, such as scatter radiation, limit the quantitative accuracy of conventional scintillation crystal-based SPECT. Semiconductor detectors such as CZT overcome these deficiencies through superior energy resolution. To our knowledge, little scientific information exists regarding the accuracy of quantitative analysis in CZT-based pre-clinical SPECT systems for different isotopes. The aim of this study was to assess the quantitative accuracy of CZT-based pre-clinical SPECT for four isotopes: 201Tl, 99mTc, 123I, and 111In. The quantitative accuracy of the CZT-based Triumph X-SPECT (Gamma-Medica Ideas, Northridge, CA, U.S.A.) was compared with that of a conventional SPECT using GATE simulation. Quantitative errors due to the attenuation and scatter effects were evaluated for all four isotopes with energy windows of 5%, 10%, and 20%. A spherical source containing the isotope was placed at the center of the air-or-water-filled mouse-sized cylinder phantom. The CZT-based pre-clinical SPECT was more accurate than the conventional SPECT. For example, in the conventional SPECT with an energy window of 10%, scatter effects degraded quantitative accuracy by up to 11.52%, 5.10%, 2.88%, and 1.84% for 201Tl, 99mTc, 123I, and 111In, respectively. However, with the CZT-based pre-clinical SPECT, the degradations were only 9.67%, 5.45%, 2.36%, and 1.24% for 201Tl, 99mTc, 123I, and 111In, respectively. As the energy window was increased, the quantitative errors increased in both SPECT systems. Additionally, the isotopes with lower energy of photon emissions had greater quantitative error. Our results demonstrated that the CZT-based pre-clinical SPECT had lower overall quantitative errors due to reduced scatter and high detection efficiency. Furthermore, the results of this systematic assessment quantifying the accuracy of these SPECT

  6. Can free open access resources strengthen knowledge-based emerging public health priorities, policies and programs in Africa? [version 1; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Ernest Tambo

    2016-05-01

    Full Text Available Tackling emerging epidemics and infectious diseases burden in Africa requires increasing unrestricted open access and free use or reuse of regional and global policies reforms as well as timely communication capabilities and strategies. Promoting, scaling up data and information sharing between African researchers and international partners are of vital importance in accelerating open access at no cost. Free Open Access (FOA health data and information acceptability, uptake tactics and sustainable mechanisms are urgently needed. These are critical in establishing real time and effective knowledge or evidence-based translation, proven and validated approaches, strategies and tools to strengthen and revamp health systems.  As such, early and timely access to needed emerging public health information is meant to be instrumental and valuable for policy-makers, implementers, care providers, researchers, health-related institutions and stakeholders including populations when guiding health financing, and planning contextual programs.

  7. Clinical studies with oral lipid based formulations of poorly soluble compounds

    DEFF Research Database (Denmark)

    Fatouros, Dimitrios; Karpf, Ditte M; Nielsen, Flemming S

    2007-01-01

    of these properties on the in vivo performance of the formulation. Equally important is the effect of concurrent food intake on the bioavailability of poorly soluble compounds. The effect of food on the bioavailability of compounds formulated in lipid and surfactant based formulations is also reviewed.......This work is an attempt to give an overview of the clinical data available on lipid based formulations. Lipid and surfactant based formulations are recognized as a feasible approach to improve bioavailability of poorly soluble compounds. However not many clinical studies have been published so far....... Several drug products intended for oral administration have been marketed utilizing lipid and surfactant based formulations. Sandimmune((R)) and Sandimmune Neoral((R)) (cyclosporin A, Novartis), Norvir((R)) (ritonavir), and Fortovase((R)) (saquinavir) have been formulated in self-emulsifying drug delivery...

  8. Task-based learning programme for clinical years of medical education.

    Science.gov (United States)

    Ozkan, Hasan; Degirmenci, Berna; Musal, Berna; Itil, Oya; Akalin, Elif; Kilinc, Oguz; Ozkan, Sebnem; Alici, Emin

    2006-03-01

    Task-based learning (TBL) is an educational strategy recommended for the later years of the medical education programme. The TBL programme was adopted for clinical years in the 2000-2001 academic year in Dokuz Eylul University School of Medicine (DEUSM). The aim of this paper is to describe the TBL programme of DEUSM. DEUSM outlined 50 clinical tasks for fourth-year students and 37 for fifth-year students. The tasks were grouped into four and five blocks. Interdisciplinary practicals, lectures and patient visits were organised in each task's schedule. The tasks were the focus of learning and each discipline contributed its own learning opportunities to the attached tasks. Formative and summative methods were used to evaluate the programme. Based on the experience and feedback provided by the students and trainers, the authors considered TBL an applicable and advisable approach for the clinical years of medical education.

  9. Mindfulness-based stress reduction for comorbid anxiety and depression: case report and clinical considerations.

    Science.gov (United States)

    Hazlett-Stevens, Holly

    2012-11-01

    Growing research literature has documented the effectiveness of mindfulness-based interventions for anxiety and depressive disorders. Mindfulness-based stress reduction (MBSR) teaches a series of mindfulness meditation and yoga practices, delivered in a group format during eight weekly sessions plus one full-day session. This case report demonstrates how MBSR was associated with dramatic clinical improvement of an individual with symptoms of panic, generalized anxiety, and depression. Scores on clinical assessment measures suggested clinically severe levels of anxious arousal, generalized anxiety, worry, fear of negative evaluation, and depression at the beginning of the intervention. The scores on all these measures fell well within normal limits 7 weeks later at the end of the intervention, and no remaining symptoms were reported afterward. Increased life satisfaction and quality of life were documented as well. This case illustrates the potential benefit of MBSR as an alternative or adjunctive treatment for comorbid anxiety and depressive disorder symptoms.

  10. [Exercise is medicine: development and evidence-based practice in clinical exercise physiology].

    Science.gov (United States)

    Zhou, Shi

    2014-08-01

    It has been well established that appropriate physical activity and exercise play an important role in promotion of health and fitness, prevention of disease and treatment and rehabilitation of health conditions. However, practice based on scientific evidence, in respect of the role and effectiveness of exercise interventions in prevention and treatment of diseases, has only been promoted and implemented in the fields of clinical exercise physiology, public health and medicine in recent years. This brief review provides an introduction of the concept of "Exercise is Medicine", the development and evidence-based practice in Clinical Exercise Physiology, and the role and training of Clinical Exercise Physiologist in the health care system of some other countries.

  11. Clarification of Safe Delivery by Iranian Experts Based on Clinical Governance: A Qualitative Study

    Directory of Open Access Journals (Sweden)

    Forozun Olfati

    2015-10-01

    Full Text Available Objective:To clarify the principles of a safe delivery based on Clinical Governance Criteria, as recommended by the pertinent experts.Materials and methods:The current study was part of a qualitative research conducted by content analysis method in 2013 and purposive sampling, performing 24 in-depth interviews based on semi-structured questions and analyzed using thematic content analysis. The participants in this research included midwives, obstetricians, managers, and hospital doctors. The data were under continuous consideration and comparative analysis in order to achieve data saturation.Results:The main concepts derived from interpretations of the pertinent experts include: Patient & Public involvement; Risk Management; Education; Clinical efficiency; Clinical audit; Personnel & Management.Conclusion:In a safe delivery, there is a vicious cycle of causes the elimination of which is only possible through benchmarking patterns that attend to most aspects of a safe delivery.Changes to services require utilization of appropriate change management strategies.

  12. Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.

    Science.gov (United States)

    Hollander, Ilyssa

    2006-02-01

    In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical abortion pill was approved 4 years after its application, and 17 years after research was first permitted. Congruently, the Ministry of Health in Japan legalized Viagra in 6 months, while oral contraceptives were approved 35 years after the ministry received initial applications. The pharmaceutical review agencies in each country are founded on safety and efficacy standards, in which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products under scrutiny. Pharmaceutical regulations were effectively ignored or manipulated in the United States during the review process for medical abortion, and were applied inconsistently in Japan--ultimately yielding results that happened to conform to contemporary sociopolitical beliefs. Such disregard of legislation holds serious ramifications for public health, national consumer trust and the pharmaceutical industry. It is imperative that external pressures remain outside the scope of drug approval processes.

  13. Comparison of Clinical Effects of Au-Pt Based and Ni-Cr Based Porcelain Crowns

    Institute of Scientific and Technical Information of China (English)

    Li-chun Wu; Ye Shi; Teng Ma

    2012-01-01

    Objective To compare the long-term clinical effects of two kinds of crowns and bridges made of porcelain fused to Au-Pt alloy and Ni-Cr alloy.Methods A total of 131 teeth (64 patients) were rehabilitated using porcelain-fused-to-metal crowns,among which 59 were rehabilitated with Au-Pt alloy metal ceramic crown and 72 with Ni-Cr alloy metal ceramic crown.The porcelain fracture,shade,marginal adaptation,gingival discoloration,and gingival status after finishing restoration and 36 months of follow-up were evaluated.Results After 36 months of restoration,porcelain fused to Au-Pt alloy crown showed better clinical effects than porcelain fused to Ni-Cr alloy crown in shade,marginal adaptation,gingival discoloration,as well as gingival status (all P<0.05).Conclusion The Au-Pt alloy ceramic crown is superior to Ni-Cr alloy ceramic crown in long-term clinical effects.

  14. ISS-N1 makes the First FDA-approved Drug for Spinal Muscular Atrophy.

    Science.gov (United States)

    Ottesen, Eric W

    2017-01-01

    Spinal muscular atrophy (SMA) is one of the leading genetic diseases of children and infants. SMA is caused by deletions or mutations of Survival Motor Neuron 1 (SMN1) gene. SMN2, a nearly identical copy of SMN1, cannot compensate for the loss of SMN1 due to predominant skipping of exon 7. While various regulatory elements that modulate SMN2 exon 7 splicing have been proposed, intronic splicing silencer N1 (ISS-N1) has emerged as the most promising target thus far for antisense oligonucleotide-mediated splicing correction in SMA. Upon procuring exclusive license from the University of Massachussets Medical School in 2010, Ionis Pharmaceuticals (formerly ISIS Pharamaceuticals) began clinical development of Spinraza(™) (synonyms: Nusinersen, IONIS-SMNRX, ISIS-SMNRX), an antisense drug based on ISS-N1 target. Spinraza(™) showed very promising results at all steps of the clinical development and was approved by US Food and Drug Administration (FDA) on December 23, 2016. Spinraza(™) is the first FDA-approved treatment for SMA and the first antisense drug to restore expression of a fully functional protein via splicing correction. The success of Spinraza(™) underscores the potential of intronic sequences as promising therapeutic targets and sets the stage for further improvement of antisense drugs based on advanced oligonucleotide chemistries and delivery protocols.

  15. Image artifacts from MR-based attenuation correction in clinical, whole-body PET/MRI

    DEFF Research Database (Denmark)

    Keller, Sune H; Holm, Søren; Hansen, Adam E;

    2013-01-01

    Integrated whole-body PET/MRI tomographs have become available. PET/MR imaging has the potential to supplement, or even replace combined PET/CT imaging in selected clinical indications. However, this is true only if methodological pitfalls and image artifacts arising from novel MR-based attenuation...

  16. Implementing an assessment-based communication skills training in pre-clinical phase: an IMU experience.

    Science.gov (United States)

    Lukman, H; Beevi, Z; Mohamadou, G; Yeap, R

    2006-06-01

    This article describes the communication skills programme of the International Medical University, which adopts an integrated medical curriculum. The programme, implemented in February 2005, is based on a systematic framework aimed at teaching students basic interpersonal communication skills progressively and continuously throughout the pre-clinical phase.

  17. 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.

  18. Conveying clinical reasoning based on visual observation via eye-movement modelling examples

    NARCIS (Netherlands)

    Jarodzka, Halszka; Balslev, Thomas; Holmqvist, Kenneth; Nyström, Marcus; Scheiter, Katharina; Gerjets, Peter; Eika, Berit

    2012-01-01

    Jarodzka, H., Balslev, T., Holmqvist, K., Nyström, M., Scheiter, K., Gerjets, P., & Eika, B. (2012). Conveying clinical reasoning based on visual observation via eye-movement modelling examples. Instructional Science, 40(5), 813-827. doi:10.1007/s11251-012-9218-5

  19. Telephone-Administered Cognitive Behavioral Therapy for Veterans Served by Community-Based Outpatient Clinics

    Science.gov (United States)

    Mohr, David C.; Carmody, Timothy; Erickson, Lauren; Jin, Ling; Leader, Julie

    2011-01-01

    Objective: Multiple trials have found telephone-administered cognitive behavioral therapy (T-CBT) to be effective for the treatment of depression. The aim of this study was to evaluate T-CBT for the treatment of depression among veterans served by community-based outpatient clinics (CBOCs) outside of major urban areas. Method: Eighty-five veterans…

  20. Competency-Based Training: Objective Structured Clinical Exercises (OSCE) in Marriage and Family Therapy

    Science.gov (United States)

    Miller, John K.

    2010-01-01

    The field of marriage and family therapy (MFT) has recently engaged in the process of defining core competencies for the profession. Many MFT training programs are adapting their curriculum to develop more competency-based training strategies. The Objective Structured Clinical "Examination" (OSCE) is widely used in the medical profession to assess…

  1. An Antipodean Evaluation of Problem-Based Learning by Clinical Educators.

    Science.gov (United States)

    Williams, Allison F.

    1999-01-01

    The use of problem-based learning in an Australian nursing education program was evaluated through interviews with 14 clinical teachers. They saw improvement in students' self-direction and holistic views of patients, but felt students lacked psychomotor skills and fundamental knowledge of anatomy and physiology. (SK)

  2. Conveying clinical reasoning based on visual observation via eye-movement modelling examples

    NARCIS (Netherlands)

    Jarodzka, Halszka; Balslev, Thomas; Holmqvist, Kenneth; Nyström, Marcus; Scheiter, Katharina; Gerjets, Peter; Eika, Berit

    2012-01-01

    Jarodzka, H., Balslev, T., Holmqvist, K., Nyström, M., Scheiter, K., Gerjets, P., & Eika, B. (2012). Conveying clinical reasoning based on visual observation via eye-movement modelling examples. Instructional Science, 40(5), 813-827. doi:10.1007/s11251-012-9218-5

  3. Support for Offering Sexual Health Services through School-Based Health Clinics

    Science.gov (United States)

    Moore, Michele Johnson; Barr, Elissa; Wilson, Kristina; Griner, Stacey

    2016-01-01

    Background: Numerous studies document support for sexuality education in the schools. However, there is a dearth of research assessing support for sexual health services offered through school-based health clinics (SBHCs). The purpose of this study was to assess voter support for offering 3 sexual health services (STI/HIV testing, STI/HIV…

  4. A Survey on Dementia Training Needs among Staff at Community-Based Outpatient Clinics

    Science.gov (United States)

    Adler, Geri; Lawrence, Briana M.; Ounpraseuth, Songthip T.; Asghar-Ali, Ali Abbas

    2015-01-01

    Dementia is a major public health concern. Educating health-care providers about dementia warning signs, diagnosis, and management is paramount to fostering clinical competence and improving patient outcomes. The objective of this project was to describe and identify educational and training needs of staff at community-based outpatient clinics…

  5. An Antipodean Evaluation of Problem-Based Learning by Clinical Educators.

    Science.gov (United States)

    Williams, Allison F.

    1999-01-01

    The use of problem-based learning in an Australian nursing education program was evaluated through interviews with 14 clinical teachers. They saw improvement in students' self-direction and holistic views of patients, but felt students lacked psychomotor skills and fundamental knowledge of anatomy and physiology. (SK)

  6. Automatic Domain Adaptation of Word Sense Disambiguation Based on Sublanguage Semantic Schemata Applied to Clinical Narrative

    Science.gov (United States)

    Patterson, Olga

    2012-01-01

    Domain adaptation of natural language processing systems is challenging because it requires human expertise. While manual effort is effective in creating a high quality knowledge base, it is expensive and time consuming. Clinical text adds another layer of complexity to the task due to privacy and confidentiality restrictions that hinder the…

  7. OntoCR: A CEN/ISO-13606 clinical repository based on ontologies.

    Science.gov (United States)

    Lozano-Rubí, Raimundo; Muñoz Carrero, Adolfo; Serrano Balazote, Pablo; Pastor, Xavier

    2016-04-01

    To design a new semantically interoperable clinical repository, based on ontologies, conforming to CEN/ISO 13606 standard. The approach followed is to extend OntoCRF, a framework for the development of clinical repositories based on ontologies. The meta-model of OntoCRF has been extended by incorporating an OWL model integrating CEN/ISO 13606, ISO 21090 and SNOMED CT structure. This approach has demonstrated a complete evaluation cycle involving the creation of the meta-model in OWL format, the creation of a simple test application, and the communication of standardized extracts to another organization. Using a CEN/ISO 13606 based system, an indefinite number of archetypes can be merged (and reused) to build new applications. Our approach, based on the use of ontologies, maintains data storage independent of content specification. With this approach, relational technology can be used for storage, maintaining extensibility capabilities. The present work demonstrates that it is possible to build a native CEN/ISO 13606 repository for the storage of clinical data. We have demonstrated semantic interoperability of clinical information using CEN/ISO 13606 extracts. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. The Transfer of Problem-Based Learning Skills to Clinical Practice

    Science.gov (United States)

    Stanton, Marie T.; Guerin, Suzanne; Barret, Terry

    2017-01-01

    The purpose of this article is to present and discuss the reported impact of a fully problem-based learning (PBL) master's program on the way graduates worked with patients and colleagues in Ireland. These graduates had completed a sixteen-month fully PBL master's in sonography while concurrently working in clinical practice. Semi-structured…

  9. Developing Memory Clinics in Primary Care: An Evidence-Based Interprofessional Program of Continuing Professional Development

    Science.gov (United States)

    Lee, Linda; Weston, W. Wayne; Hillier, Loretta M.

    2013-01-01

    Introduction: Primary care is challenged to meet the needs of patients with dementia. A training program was developed to increase capacity for dementia care through the development of Family Health Team (FHT)-based interprofessional memory clinics. The interprofessional training program consisted of a 2-day workshop, 1-day observership, and 2-day…

  10. Measuring knowledge and clinical reasoning skills in a problem-based curriculum

    NARCIS (Netherlands)

    H.P.A. Boshuizen (Henny); C. van der Vleuten; H.G. Schmidt (Henk); M. Machiels-Bongaerts

    1997-01-01

    textabstractThe purpose of this study was to investigate the validity of the Progress Test that was specially designed for measuring the growth of knowledge and clinical reasoning skills in a problem-based medical curriculum. Scores and subscores of students from the different categories of the Prog

  11. A web-based family health record supporting genealogical clinical anamnesis.

    Science.gov (United States)

    Andreoni, Matteo; Beretta, Diego; Carzaniga, Antonio; Masseroli, Marco

    2007-10-11

    We developed "Family Pathology", a Web-based system that allows recording and evaluating the clinical data of a patient and his/her relatives. The goal is to enable a physician to identify not only an occurred disease and the prescribed medications, but also its possible recurrence within the patients family in order to highlight possible genealogical pathologies and risk factors.

  12. Risk Based Monitoring (RBM: A global study focusing on perception and merits among clinical investigational sites

    Directory of Open Access Journals (Sweden)

    Prajna P. Kumar

    2016-12-01

    Conclusion: This unique study performed across ten emerging and developed countries strongly supported the need for systematic global training, education, and implementation of RBM regulatory guidance, with an aim for better safety of subjects and improved quality of clinical trial data. Furthermore, studies with larger sample sizes are recommended to provide an evidence-based approach.

  13. The Use of Personal Digital Assistants as Tools for Work-Based Learning in Clinical Internships

    Science.gov (United States)

    Akkerman, Sanne; Filius, Renee

    2011-01-01

    Though mobile technologies have been studied, their specific value in supporting work-based learning has not yet been investigated. This paper describes a small exploratory study in health care education in which medical students work in clinical practice. The study investigates both the perceived potential as well as the actual role of PDAs in…

  14. Unit-based clinical pharmacists' prevention of serious medication errors in pediatric inpatients.

    Science.gov (United States)

    Kaushal, Rainu; Bates, David W; Abramson, Erika L; Soukup, Jane R; Goldmann, Donald A

    2008-07-01

    Rates of serious medication errors in three pediatric inpatient units (intensive care, general medical, and general surgical) were measured before and after introduction of unit-based clinical pharmacists. Error rates on the study units and similar patient care units in the same hospital that served as controls were determined during six- to eight-week baseline periods and three-month periods after the introduction of unit-based clinical pharmacists (full-time in the intensive care unit [ICU] and mornings only on the general units). Nurses trained by the investigators reviewed medication orders, medication administration records, and patient charts daily to detect errors, near misses, and adverse drug events (ADEs) and determine whether near misses were intercepted. Two physicians independently reviewed and rated all data collected by the nurses. Serious medication errors were defined as preventable ADEs and nonintercepted near misses. The baseline rates of serious medication errors per 1000 patient days were 29 for the ICU, 8 for the general medical unit, and 7 for the general surgical unit. With unit-based clinical pharmacists, the ICU rate dropped to 6 per 1000 patient days. In the general care units, there was no reduction from baseline in the rates of serious medication errors. A full-time unit-based clinical pharmacist substantially decreased the rate of serious medication errors in a pediatric ICU, but a part-time pharmacist was not as effective in decreasing errors in pediatric general care units.

  15. Evaluation of Criteria-Based Clinical Audit in Improving Quality of ...

    African Journals Online (AJOL)

    Erah

    Study evaluated criteria–based clinical audit in measuring and improving quality of ... 81%, p = 0.000), eclampsia (54.3 to 90%, p=0.00), obstructed labour (81.7 to .... Pharmacy and Laboratory. ... Respiratory rate and tendon reflexes is monitored when magnesium sulphate is used. ... Data entry and analysis were performed.

  16. Association of School-Based Influenza Vaccination Clinics and School Absenteeism--Arkansas, 2012-2013

    Science.gov (United States)

    Gicquelais, Rachel E.; Safi, Haytham; Butler, Sandra; Smith, Nathaniel; Haselow, Dirk T.

    2016-01-01

    Background: Influenza is a major cause of seasonal viral respiratory illness among school-aged children. Accordingly, the Arkansas Department of Health (ADH) coordinates >800 school-based influenza immunization clinics before each influenza season. We quantified the relationship between student influenza vaccination in Arkansas public schools…

  17. Measuring knowledge and clinical reasoning skills in a problem-based curriculum

    NARCIS (Netherlands)

    H.P.A. Boshuizen (Henny); C. van der Vleuten; H.G. Schmidt (Henk); M. Machiels-Bongaerts

    1997-01-01

    textabstractThe purpose of this study was to investigate the validity of the Progress Test that was specially designed for measuring the growth of knowledge and clinical reasoning skills in a problem-based medical curriculum. Scores and subscores of students from the different categories of the

  18. Learning from Successful School-based Vaccination Clinics during 2009 pH1N1

    Science.gov (United States)

    Klaiman, Tamar; O'Connell, Katherine; Stoto, Michael A.

    2014-01-01

    Background: The 2009 H1N1 vaccination campaign was the largest in US history. State health departments received vaccines from the federal government and sent them to local health departments (LHDs) who were responsible for getting vaccines to the public. Many LHD's used school-based clinics to ensure children were the first to receive limited…

  19. A Survey on Dementia Training Needs among Staff at Community-Based Outpatient Clinics

    Science.gov (United States)

    Adler, Geri; Lawrence, Briana M.; Ounpraseuth, Songthip T.; Asghar-Ali, Ali Abbas

    2015-01-01

    Dementia is a major public health concern. Educating health-care providers about dementia warning signs, diagnosis, and management is paramount to fostering clinical competence and improving patient outcomes. The objective of this project was to describe and identify educational and training needs of staff at community-based outpatient clinics…

  20. Clinical trials in the development of biosimilars: future considerations

    Directory of Open Access Journals (Sweden)

    Huneycutt BJ

    2015-07-01

    Full Text Available Brenda J Huneycutt,1 Earl Gillespie,2 Gillian R Woollett1 1FDA Regulatory Strategy and Policy, Avalere Health, LLC, Washington, DC, 2Health Advances, LLC, Weston, MA, USA Abstract: A number of biosimilars have been approved in highly regulated markets throughout the world. Biosimilar development follows its own unique path – relying primarily on analytics to compare a potential biosimilar to its reference product and giving a reduced, confirmatory role to clinical trials. In addition, the ability to extrapolate data to support approval for indications without a clinical trial gives this abbreviated pathway potential significant value. In fact, so far, all the approved biosimilars in Europe received approval for all the reference product's indications. However, this is not the case in other regions. Regulatory agencies of the highly regulated markets agree in general on many principles underlying biosimilar product development and approval, but differ in important aspects as reflected by the data burdens and approval decisions for four classes of products explored in this paper – somatropins, filgrastims, epoetins, and infliximabs. These case studies also highlight some biosimilar sponsor latitude as reflected in the varying clinical data packages submitted to the same regulatory agency for biosimilars to the same reference product. There also exists biosimilar sponsor latitude in deciding whether to use the biosimilar pathway at all or seek approval through the stand-alone biologics regulatory pathway. This, of course, is a commercial decision based on the weights each biosimilar sponsor gives to the various risks and benefits for each option, for each product, and for each market. Further, it remains an open question whether a single, biosimilar development plan for global commercialization can be used to satisfy each regulatory agency. Keywords: somatropin, filgrastim, epoetin, infliximab

  1. Clinic-based versus outsourced implementation of a diabetes health literacy intervention.

    Science.gov (United States)

    Wolf, Michael S; Seligman, Hilary; Davis, Terry C; Fleming, David A; Curtis, Laura M; Pandit, Anjali U; Parker, Ruth M; Schillinger, Dean; Dewalt, Darren A

    2014-01-01

    We compared two implementation approaches for a health literacy diabetes intervention designed for community health centers. A quasi-experimental, clinic-randomized evaluation was conducted at six community health centers from rural, suburban, and urban locations in Missouri between August 2008 and January 2010. In all, 486 adult patients with type 2 diabetes mellitus participated. Clinics were set up to implement either: 1) a clinic-based approach that involved practice re-design to routinely provide brief diabetes education and counseling services, set action-plans, and perform follow-up without additional financial resources [CARVE-IN]; or 2) an outsourced approach where clinics referred patients to a telephone-based diabetes educator for the same services [CARVE-OUT]. The fidelity of each intervention was determined by the number of contacts with patients, self-report of services received, and patient satisfaction. Intervention effectiveness was investigated by assessing patient knowledge, self-efficacy, health behaviors, and clinical outcomes. Carve-out patients received on average 4.3 contacts (SD = 2.2) from the telephone-based diabetes educator versus 1.7 contacts (SD = 2.0) from the clinic nurse in the carve-in arm (p diabetes knowledge, self-efficacy, or health behaviors were found between the two approaches. However, clinical outcomes did vary in multivariable analyses; carve-out patients had a lower HbA1c (β = -0.31, 95 % CI -0.56 to -0.06, p = 0.02), systolic blood pressure (β = -3.65, 95 % CI -6.39 to -0.90, p = 0.01), and low-density lipoprotein (LDL) cholesterol (β = -7.96, 95 % CI -10.08 to -5.83, p diabetes education and counseling approach for community health centers appears more feasible than clinic-based models. Patients receiving the carve-out strategy also demonstrated better clinical outcomes compared to those receiving the carve-in approach. Study limitations and unclear causal mechanisms explaining

  2. 40 CFR 123.61 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false Approval process. 123.61 Section 123... REQUIREMENTS Program Approval, Revision, and Withdrawal § 123.61 Approval process. (a) After determining that a...; and (6) Briefly outline the fundamental aspects of the State's proposed program, and the process...

  3. 40 CFR 145.31 - Approval process.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Approval process. 145.31 Section 145.31 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) STATE UIC PROGRAM REQUIREMENTS Program Approval, Revision and Withdrawal § 145.31 Approval process....

  4. 12 CFR 611.510 - Approval procedures.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Approval procedures. 611.510 Section 611.510 Banks and Banking FARM CREDIT ADMINISTRATION FARM CREDIT SYSTEM ORGANIZATION Transfer of Authorities § 611.510 Approval procedures. (a) Upon receipt of approval of a resolution by the Farm...

  5. 30 CFR 22.10 - Approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 22.10 Section 22.10 Mineral... MINING PRODUCTS PORTABLE METHANE DETECTORS § 22.10 Approval plate. (a) Attachment to be made by manufacturers. (1) Manufacturers shall attach, stamp, or mold an approval plate on each permissible methane...

  6. 30 CFR 20.13 - Approval plate.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approval plate. 20.13 Section 20.13 Mineral... MINING PRODUCTS ELECTRIC MINE LAMPS OTHER THAN STANDARD CAP LAMPS § 20.13 Approval plate. The manufacturer shall attach, stamp, or mold an approval plate on the battery container or housing of each...

  7. 32 CFR 552.77 - Suspension approval.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Suspension approval. 552.77 Section 552.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY MILITARY RESERVATIONS AND....77 Suspension approval. The installation commander will personally approve all cases in...

  8. Two Drating loans examination and approval standards based on senior law%基于高级法的两维评级贷款审批标准

    Institute of Scientific and Technical Information of China (English)

    杨群

    2012-01-01

    新资本协议框架下,公司暴露的风险加权资产依赖于客户的违约概率和债项的违约损失率。随着内部评级高级法的实施,商业银行将逐步建立和完善客户评级与债项评级体系,用于估算违约概率和违约损失率。本文深入分析了新资本协议的资本要求计算公式,提出以资本要求低于8%为导向、以客户评级和债项评级为基础的贷款两维准入标准。目的是帮助商业银行有效管理资本充足率,以及解决中小企业融资难等问题。%Under the Basel Ⅱ framework,the derivation of risk-weighted assets for corporate exposure is dependent on estimates of probability of default(PD) and loss given default(LGD).Therefore,with the implementation of advanced IRB approach,a commercial bank must establish in its IRB rating system two separate and distinct dimensions,i.e.borrower rating and transaction rating.After studying the capital requirement formula by Basel Ⅱ,I propose two-dimension admission criterion for short term loan,which is oriented to capital requirement lower than 8% and based on borrower rating and transaction rating.My objective is to help commercial banks control capital adequacy ratio effectively and to solve small-and medium-sized entities borrowers' difficulty in acquiring loan.

  9. TU-F-BRB-03: Clinical Implementation of MR-Based Motion Management

    Energy Technology Data Exchange (ETDEWEB)

    Glide-Hurst, C. [Henry Ford Health System (United States)

    2015-06-15

    The current clinical standard of organ respiratory imaging, 4D-CT, is fundamentally limited by poor soft-tissue contrast and imaging dose. These limitations are potential barriers to beneficial “4D” radiotherapy methods which optimize the target and OAR dose-volume considering breathing motion but rely on a robust motion characterization. Conversely, MRI imparts no known radiation risk and has excellent soft-tissue contrast. MRI-based motion management is therefore highly desirable and holds great promise to improve radiotherapy of moving cancers, particularly in the abdomen. Over the past decade, MRI techniques have improved significantly, making MR-based motion management clinically feasible. For example, cine MRI has high temporal resolution up to 10 f/s and has been used to track and/or characterize tumor motion, study correlation between external and internal motions. New MR technologies, such as 4D-MRI and MRI hybrid treatment machines (i.e. MR-linac or MR-Co60), have been recently developed. These technologies can lead to more accurate target volume determination and more precise radiation dose delivery via direct tumor gating or tracking. Despite all these promises, great challenges exist and the achievable clinical benefit of MRI-based tumor motion management has yet to be fully explored, much less realized. In this proposal, we will review novel MR-based motion management methods and technologies, the state-of-the-art concerning MRI development and clinical application and the barriers to more widespread adoption. Learning Objectives: Discuss the need of MR-based motion management for improving patient care in radiotherapy. Understand MR techniques for motion imaging and tumor motion characterization. Understand the current state of the art and future steps for clinical integration. Henry Ford Health System holds research agreements with Philips Healthcare. Research sponsored in part by a Henry Ford Health System Internal Mentored Grant.

  10. Hunan Rare Earth Group Approved

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    <正>Following Guangdong,Guangxi,Fujian and Jiangxi,Hunan announced that it would consolidate its rare earth resources-the consolidation plan of Hunan Rare Earth Group has been approved. Consolidation of the rare earth industry of south China is in full swing.According to "Several Opinions of the State Council on Promoting the Sustainable and Healthy Development of Rare Earth Industry"(hereinafter referred to as "Several Opinions")released in 2011,

  11. 42 CFR 84.33 - Approval labels and markings; approval of contents; use.

    Science.gov (United States)

    2010-10-01

    ... Approval and Disapproval § 84.33 Approval labels and markings; approval of contents; use. (a) Full-scale... at the following locations: Respirator type Label type Location Self-contained breathing apparatus... to whom it is issued to maintain or cause to be maintained the approved quality control sampling...

  12. Immune Monitoring in Cancer Vaccine Clinical Trials: Critical Issues of Functional Flow Cytometry-Based Assays

    Directory of Open Access Journals (Sweden)

    Iole Macchia

    2013-01-01

    Full Text Available The development of immune monitoring assays is essential to determine the immune responses against tumor-specific antigens (TSAs and tumor-associated antigens (TAAs and their possible correlation with clinical outcome in cancer patients receiving immunotherapies. Despite the wide range of techniques used, to date these assays have not shown consistent results among clinical trials and failed to define surrogate markers of clinical efficacy to antitumor vaccines. Multiparameter flow cytometry- (FCM- based assays combining different phenotypic and functional markers have been developed in the past decade for informative and longitudinal analysis of polyfunctional T-cells. These technologies were designed to address the complexity and functional heterogeneity of cancer biology and cellular immunity and to define biomarkers predicting clinical response to anticancer treatment. So far, there is still a lack of standardization of some of these immunological tests. The aim of this review is to overview the latest technologies for immune monitoring and to highlight critical steps involved in some of the FCM-based cellular immune assays. In particular, our laboratory is focused on melanoma vaccine research and thus our main goal was the validation of a functional multiparameter test (FMT combining different functional and lineage markers to be applied in clinical trials involving patients with melanoma.

  13. Automatic Selection of Clinical Trials Based on A Semantic Web Approach.

    Science.gov (United States)

    Cuggia, Marc; Campillo-Gimenez, Boris; Bouzille, Guillaume; Besana, Paolo; Jouini, Wassim; Dufour, Jean-Charles; Zekri, Oussama; Gibaud, Isabelle; Garde, Cyril; Duvauferier, Regis

    2015-01-01

    Recruitment of patients in clinical trials is nowadays preoccupying, as the inclusion rate is particularly low. The main identified factors are the multiplicity of open clinical trials, the high number and complexity of eligibility criteria, and the additional workload that a systematic search of the clinical trials a patient could be enrolled in for a physician. The principal objective of the ASTEC project is to automate the prescreening phase during multidisciplinary meetings (MDM). This paper presents the evaluation of a computerized recruitment support systems (CRSS) based on semantic web approach. The evaluation of the system was based on data collected retrospectively from a 6 month period of MDM in Urology and on 4 clinical trials of prostate cancer. The classification performance of the ASTEC system had a precision of 21%, recall of 93%, and an error rate equal to 37%. Missing data was the main issue encountered. The system was designed to be both scalable to other clinical domains and usable during MDM process.

  14. [Evidence-based clinical practice. Part II--Searching evidence databases].

    Science.gov (United States)

    Bernardo, Wanderley Marques; Nobre, Moacyr Roberto Cuce; Jatene, Fábio Biscegli

    2004-01-01

    The inadequacy of most of traditional sources for medical information, like textbook and review article, do not sustained the clinical decision based on the best evidence current available, exposing the patient to a unnecessary risk. Although not integrated around clinical problem areas in the convenient way of textbooks, current best evidence from specific studies of clinical problems can be found in an increasing number of Internet and electronic databases. The sources that have already undergone rigorous critical appraisal are classified as secondary information sources, others that provide access to original article or abstract, as primary information source, where the quality assessment of the article rely on the clinician oneself . The most useful primary information source are SciELO, the online collection of Brazilian scientific journals, and Medline, the most comprehensive database of the USA National Library of Medicine, where the search may start with use of keywords, that were obtained at the structured answer construction (P.I.C.O.), with the addition of boolean operators "AND", "OR", "NOT". Between the secondary information sources, some of them provide critically appraised articles, like ACP Journal Club, Evidence Based Medicine and InfoPOEMs, others provide evidences organized as online texts, such as "Clinical Evidence" and "UpToDate", and finally, Cochrane Library are composed by systematic reviews of randomized controlled trials. To get studies that could answer the clinical question is part of a mindful practice, that is, becoming quicker and quicker and dynamic with the use of PDAs, Palmtops and Notebooks.

  15. Nonattendance at a hospital-based otolaryngology clinic: a preliminary analysis within a universal healthcare system.

    Science.gov (United States)

    Zirkle, Molly S; McNelles, Laurie R

    2011-08-01

    Missed appointments at specialty clinics generate concerns for physicians and clinic administrators. Appointment nonattendance obstructs the provision of timely medical interventions and the maximization of systemic efficiencies. Yet, empiric study of factors associated with missed appointments at adult specialty clinics has received little attention in North America. We conducted a preliminary study of otolaryngology clinic nonattendance in the context of a universal healthcare system environment in Canada. Our data were based on the schedule of 1,512 new patient appointments at a hospital-based clinic from May 1 through Sept. 30, 2008. Gathered information included the employment status of the attending physician (i.e., full-time vs. part-time), the patient's sex and age, the day of the week and the time of the appointment, and the attendance status. We found that the rate of nonattendance was 24.4% (n = 369). Nonattendance rates varied significantly according to physician employment status (more common for part-time physicians), patient sex (women) and age (younger adults), and the day of the appointment (Wednesdays), but not according to the time of day. Our findings suggest that there are predictable patient and systemic factors that influence nonattendance at medical appointments. Awareness of these factors can have implications for the delivery of healthcare services within a universal healthcare context.

  16. CLINICAL SURFACES - Activity-Based Computing for Distributed Multi-Display Environments in Hospitals

    Science.gov (United States)

    Bardram, Jakob E.; Bunde-Pedersen, Jonathan; Doryab, Afsaneh; Sørensen, Steffen

    A multi-display environment (MDE) is made up of co-located and networked personal and public devices that form an integrated workspace enabling co-located group work. Traditionally, MDEs have, however, mainly been designed to support a single “smart room”, and have had little sense of the tasks and activities that the MDE is being used for. This paper presents a novel approach to support activity-based computing in distributed MDEs, where displays are physically distributed across a large building. CLINICAL SURFACES was designed for clinical work in hospitals, and enables context-sensitive retrieval and browsing of patient data on public displays. We present the design and implementation of CLINICAL SURFACES, and report from an evaluation of the system at a large hospital. The evaluation shows that using distributed public displays to support activity-based computing inside a hospital is very useful for clinical work, and that the apparent contradiction between maintaining privacy of medical data in a public display environment can be mitigated by the use of CLINICAL SURFACES.

  17. Evaluation of clinical teaching and professional development in a problem and community-based nursing module

    Directory of Open Access Journals (Sweden)

    J.C de Villiers

    2004-09-01

    Full Text Available In South Africa the main focus is on primary health care. This affects the education and training of nurses, and training schools must respond by developing appropriate teaching modules. A school of nursing developed, implemented and revised a problem- and community- based learning module over a period of three years (1996-1998. This student-centered module focuses on students’ needs, active participation, collaboration, accountability, self-assessment, self-study, life-long learning and appropriate skills. In the formal clinical teaching environment PBL was the main approach. However, this approach was also supported by a variety of strategies, for example group discussions and scenarios. The knowledge, attitudes and professional development skills acquired in the PBL approach were then applied informally in the community setting (CBE. The purpose of the study was to evaluate a first year clinical teaching module as part of an extensive programme. A quantitative research method, a descriptive design, and a variety of data collection techniques were used. Conclusions were that clinical teaching was effective within the problem- (PBL and community-based (CBE approaches; 78% of respondents were positive about the clinical learning environment; 61 % stated that expectations were met; 81% preferred group activities, and 67% indicated that they had developed professional skills. Facilitators agreed that clinical teaching met the requirements of PBL & CBE. The pass rate also improved.

  18. Establishing the diagnostic criteria for eruption disorders based on genetic and clinical data.

    Science.gov (United States)

    Rhoads, Stephanie Golubic; Hendricks, Heather M; Frazier-Bowers, Sylvia A

    2013-08-01

    Proper diagnosis and management of eruption disturbances remains challenging but is critical to a functional occlusion. The objective of this study was to establish definitive criteria to differentiate and diagnose eruption disorders, specifically primary failure of eruption (PFE) and ankylosis. Sixty-four affected persons were placed into 3 cohorts: PFE diagnosed through confirmed PTH1R mutation (n = 11), PFE diagnosed based on clinical criteria (n = 47), and ankylosis diagnosed based on clinical criteria (n = 6). These groups were assessed to identify clinical features that differentiate PFE and ankylosis. Ninety-three percent of the subjects in the genetic and clinical PFE cohorts combined (n = 58) and 100% in the genetic PFE cohort had at least 1 infraoccluded first permanent molar. Additionally, a novel functional PTH1R mutation, 1092delG, was identified and linked to PFE in the deciduous dentition. An infraoccluded, supracrestal first molar is a hallmark of PFE, often involving both arches in the permanent or deciduous dentition, and with unilateral or bilateral affection, infraoccluded second premolar or second molar, and multiple affected adjacent teeth. Our results further suggest that PFE and ankylosis might be clinically indistinguishable without knowledge of prior trauma, treatment history, genetic information, or obliteration of the periodontal ligament space. Copyright © 2013 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  19. Final-Year Students' and Clinical instructors' Experience of Workplace-Based Assessments Used in a Small-Animal Primary-Veterinary-Care Clinical Rotation.

    Science.gov (United States)

    Weijs, Cynthia A; Coe, Jason B; Hecker, Kent G

    2015-01-01

    Final-year veterinary students must meet baseline clinical competency upon completion of their training for entry to practice. Workplace-based assessments (WBAs), widely used in human medical training to assess post-graduate students' professionalism and clinical performance, have recently been adopted in undergraduate veterinary clinical teaching environments. WBAs should support veterinary trainees' learning in a clinical teaching environment, though utility of WBAs within veterinary education may differ from that in medical training due to differences in context and in learners' stage of clinical development. We conducted focus groups with final-year veterinary students and clinical instructors following the implementation of three WBAs (Direct Observation of Procedural Skills [DOPS], the Mini-Clinical evaluation exercise [Mini-CEX], and the In-Training Evaluation Report [ITER]) during a small-animal primary-veterinary-care rotation. Students and clinical instructors viewed the DOPS and Mini-CEX as feasible and valuable learning and assessment tools that offered an overall opportunity for timely in-the-moment feedback. Instructors viewed the ITER as less feasible in the context of a service-oriented veterinary clinical teaching environment. Students believed the ITER had potential to be informative, although in its existing application the ITER had limited utility due to time constraints on instructors that prevented them from providing students with individualized and specific feedback. In service-oriented veterinary clinical teaching environments, successful implementation of WBAs requires balancing provision of feedback to students, time demands on clinical instructors, and flexibility of assessment tools.

  20. Preclinical and Clinical Development of a YFV 17 D-Based Chimeric Vaccine against West Nile Virus

    Directory of Open Access Journals (Sweden)

    Gustavo H. Dayan

    2013-12-01

    Full Text Available Substantial success has been achieved in the development and implementation of West Nile (WN vaccines for horses; however, no human WN vaccines are approved. This review focuses on the construction, pre-clinical and clinical characterization of ChimeriVax-WN02 for humans, a live chimeric vaccine composed of a yellow fever (YF 17D virus in which the prM-E envelope protein genes are replaced with the corresponding genes of the WN NY99 virus. Pre-clinical studies demonstrated that ChimeriVax-WN02 was significantly less neurovirulent than YF 17D in mice and rhesus and cynomolgus monkeys. The vaccine elicited neutralizing antibody titers after inoculation in hamsters and monkeys and protected immunized animals from lethal challenge including intracerebral inoculation of high dose of WN NY99 virus. Safety, viremia and immunogenicity of ChimeriVax-WN02 were assessed in one phase I study and in two phase II clinical trials. No safety signals were detected in the three clinical trials with no remarkable differences in incidence of adverse events (AEs between vaccine and placebo recipients. Viremia was transient and the mean viremia levels were low. The vaccine elicited strong and durable neutralizing antibody and cytotoxic T cell responses. WN epidemiology impedes a classical licensure pathway; therefore, innovative licensure strategies should be explored.