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Sample records for reported clinical effects

  1. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal

    Directory of Open Access Journals (Sweden)

    Kent David M

    2010-08-01

    Full Text Available Abstract Mounting evidence suggests that there is frequently considerable variation in the risk of the outcome of interest in clinical trial populations. These differences in risk will often cause clinically important heterogeneity in treatment effects (HTE across the trial population, such that the balance between treatment risks and benefits may differ substantially between large identifiable patient subgroups; the "average" benefit observed in the summary result may even be non-representative of the treatment effect for a typical patient in the trial. Conventional subgroup analyses, which examine whether specific patient characteristics modify the effects of treatment, are usually unable to detect even large variations in treatment benefit (and harm across risk groups because they do not account for the fact that patients have multiple characteristics simultaneously that affect the likelihood of treatment benefit. Based upon recent evidence on optimal statistical approaches to assessing HTE, we propose a framework that prioritizes the analysis and reporting of multivariate risk-based HTE and suggests that other subgroup analyses should be explicitly labeled either as primary subgroup analyses (well-motivated by prior evidence and intended to produce clinically actionable results or secondary (exploratory subgroup analyses (performed to inform future research. A standardized and transparent approach to HTE assessment and reporting could substantially improve clinical trial utility and interpretability.

  2. Health Clinic Cost Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Healthcare Cost Report Information System (HCRIS) Dataset - Independent Rural Health Clinic and Freestanding Federally Qualified Health Center (HCLINIC).This data...

  3. Effective Information Extraction Framework for Heterogeneous Clinical Reports Using Online Machine Learning and Controlled Vocabularies.

    Science.gov (United States)

    Zheng, Shuai; Lu, James J; Ghasemzadeh, Nima; Hayek, Salim S; Quyyumi, Arshed A; Wang, Fusheng

    2017-05-09

    Extracting structured data from narrated medical reports is challenged by the complexity of heterogeneous structures and vocabularies and often requires significant manual effort. Traditional machine-based approaches lack the capability to take user feedbacks for improving the extraction algorithm in real time. Our goal was to provide a generic information extraction framework that can support diverse clinical reports and enables a dynamic interaction between a human and a machine that produces highly accurate results. A clinical information extraction system IDEAL-X has been built on top of online machine learning. It processes one document at a time, and user interactions are recorded as feedbacks to update the learning model in real time. The updated model is used to predict values for extraction in subsequent documents. Once prediction accuracy reaches a user-acceptable threshold, the remaining documents may be batch processed. A customizable controlled vocabulary may be used to support extraction. Three datasets were used for experiments based on report styles: 100 cardiac catheterization procedure reports, 100 coronary angiographic reports, and 100 integrated reports-each combines history and physical report, discharge summary, outpatient clinic notes, outpatient clinic letter, and inpatient discharge medication report. Data extraction was performed by 3 methods: online machine learning, controlled vocabularies, and a combination of these. The system delivers results with F1 scores greater than 95%. IDEAL-X adopts a unique online machine learning-based approach combined with controlled vocabularies to support data extraction for clinical reports. The system can quickly learn and improve, thus it is highly adaptable.

  4. Effective Information Extraction Framework for Heterogeneous Clinical Reports Using Online Machine Learning and Controlled Vocabularies

    Science.gov (United States)

    Zheng, Shuai; Ghasemzadeh, Nima; Hayek, Salim S; Quyyumi, Arshed A

    2017-01-01

    Background Extracting structured data from narrated medical reports is challenged by the complexity of heterogeneous structures and vocabularies and often requires significant manual effort. Traditional machine-based approaches lack the capability to take user feedbacks for improving the extraction algorithm in real time. Objective Our goal was to provide a generic information extraction framework that can support diverse clinical reports and enables a dynamic interaction between a human and a machine that produces highly accurate results. Methods A clinical information extraction system IDEAL-X has been built on top of online machine learning. It processes one document at a time, and user interactions are recorded as feedbacks to update the learning model in real time. The updated model is used to predict values for extraction in subsequent documents. Once prediction accuracy reaches a user-acceptable threshold, the remaining documents may be batch processed. A customizable controlled vocabulary may be used to support extraction. Results Three datasets were used for experiments based on report styles: 100 cardiac catheterization procedure reports, 100 coronary angiographic reports, and 100 integrated reports—each combines history and physical report, discharge summary, outpatient clinic notes, outpatient clinic letter, and inpatient discharge medication report. Data extraction was performed by 3 methods: online machine learning, controlled vocabularies, and a combination of these. The system delivers results with F1 scores greater than 95%. Conclusions IDEAL-X adopts a unique online machine learning–based approach combined with controlled vocabularies to support data extraction for clinical reports. The system can quickly learn and improve, thus it is highly adaptable. PMID:28487265

  5. Effect of complete dentures on craniofacial growth of an ectodermal dysplasia patient: a clinical report.

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    Bhalla, Gaurav; Agrawal, Kaushal Kishor; Chand, Pooran; Singh, Kamleshwar; Singh, Balandra Pratap; Goel, Prachi; Alvi, Habib Ahmed

    2013-08-01

    The aim of this clinical report was to observe the effect of complete dentures on craniofacial growth and development of an ectodermal dysplasia (ED) patient. A complete anodontia patient diagnosed with ED was successfully rehabilitated with conventional complete dentures at the ages of 5, 8, and 10 years. Three sets of complete dentures were made with age-appropriate denture teeth and a bilaterally balanced lingualized occlusal scheme. Periodic follow-up and adjustment when needed was done to maintain proper oral function and esthetics. Serial cephalometric analysis exhibited a marked restriction of forward growth at the anterior nasal spine (ANS) point between 5 and 10 years of age, although there was little change from average in the anteroposterior length of the mandibular body and the height of the mandibular ramus. So, while maxillary growth was reduced, mandibular growth did not significantly change. Cast analysis showed that the increase in arch length was greater than in arch width for both the maxilla and mandible. There was little increase in alveolar ridge height in the anterior region but a considerable increase in the height of the alveolar ridge in the middle and the posterior region. Our findings concluded that the absence of teeth did not affect the growth of the jaws, and it is probable that the denture flange did not arrest the jaw growth, but rather improved the masticatory function by providing good denture stability and retention. © 2013 by the American College of Prosthodontists.

  6. Practice based evidence: incorporating clinical heterogeneity and patient-reported outcomes for comparative effectiveness research.

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    Horn, Susan D; Gassaway, Julie

    2010-06-01

    Comparative effectiveness research analyzes groups of patients and looks for associations between medical treatments and patient outcomes. To make meaningful comparisons of medical interventions, one must consider clinical heterogeneity of patient populations, intervention combinations, and outcomes. To explain how practice-based evidence (PBE) study methodology measures and controls for heterogeneity of patients, treatments, and outcomes seen in real-world clinical settings. Overview of PBE methodology. PBE study designs address comparative effectiveness by creating a comprehensive set of patient, treatment, and outcome variables, and analyzing them to identify treatments associated with better outcomes for specific types of patients. PBE studies are an alternative to randomized controlled trials, well suited to determine what works best for specific patient types, and provide clinicians with a rational basis for treatment recommendations for individual patients. They provide a holistic picture of patients, treatments, and outcomes, with no preset limits to the number of variables that can be included. Such an approach is needed for high quality comparative effectiveness research.

  7. Clinical reporting: the practitioner's responsibility.

    Science.gov (United States)

    Mauser, W W

    1980-08-01

    Information contained in a clinical report represents new directions in the practice of physical therapy and provides the stimulus for reseach and growth in the profession. The responsibility of the practitioner to share information on problems and solutions generated in the practice of physical therapy is of paramount importance. A clinical report is one method by which this information can be disseminated.

  8. Self- and rater-assessed effectiveness of "thinking-aloud" and "regular" morning report to intensify young physicians' clinical skills.

    Science.gov (United States)

    Hsu, Hui-Chi; Lee, Fa-Yauh; Yang, Ying-Ying; Tsao, Yen-Po; Lee, Wen-Shin; Chuang, Chiao-Lin; Chang, Ching-Chih; Huang, Chia-Chang; Huang, Chin-Chou; Ho, Shung-Tai

    2015-09-01

    This study compared the effects of the "thinking aloud" (TA) morning report (MR), which is characterized by sequential and interactive case discussion by all participants, with "regular" MR for clinical skill training of young physicians. Between February 2011 and February 2014, young physicians [including postgraduate year-1 (PGY1) residents, interns, and clerks) from our hospital were sequentially enrolled and followed for 3 months. The self- and rater-assessed educational values of two MR models for building up clinical skills of young physicians were compared. The junior (intern and clerk) attendees had higher self-assessed educational values scores and reported post-training application frequency of skills trained by TA MR compared with the senior (PGY1 resident) attendees. Higher average and percentage of increased overall rater-assessed OSCE scores were noted among the regular MR senior attendees and TA MR junior attendees than in their corresponding control groups (regular MR junior attendees and TA MR senior attendees). Interestingly, regular MRs provided additional beneficial effects for establishing the "professionalism, consulting skills and organization efficiency" aspects of clinical skills of senior/junior attendees. Moreover, senior and junior attendees benefited the most by participating in seven sessions of regular MR and TA MR each month, respectively. TA MR effectively trains junior attendees in basic clinical skills, whereas regular MR enhances senior attendees' "work reports, professionalism, organizational efficiency, skills in dealing with controversial and professional issues." Undoubtedly, all elements of the two MR models should be integrated together to ensure patient safety and good discipline among young physicians. Copyright © 2015. Published by Elsevier Taiwan.

  9. [Reading a clinical trial report].

    Science.gov (United States)

    Bergmann, J F; Chassany, O

    2000-04-15

    To improve medical knowledge by reading clinical trial reports it is necessary to check for the respect of the methodological rules, and to analyze and criticize the results. A control group and a randomisation are always necessary. Double blind assessment, sample size calculation, intention to treat analysis, a unique primary end point are also important. The conclusions of the trial are valid only for the population included and the clinical signification of the results, depending on the control treatment, has to be evaluated. Respect of the reading rules is necessary to assess the reliability of the conclusions, in order to promote evidence-based practice.

  10. AMELOGENESIS IMPERFECTA: A CLINICAL REPORT

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    Veena

    2015-01-01

    Full Text Available AIM: This clinical case report describes the oral rehabilitation of a young adult female patient diagnosed with hypoplastic Amelogenesis imperfecta. SUMMARY : Amelogenesis Imperfecta is a hereditary condition that affects the formation of the enamel mineralization process of both the primary and secondary dentition. It is clinically and genetically heterogeneous grou p of condition that affects both the quantity and quality of the enamel structure resulting in extensive loss of tooth tissue , poor esthetics and tooth sensitivity. The main objective for the selected treatment was to enhance the esthetics , and restoring m asticatory function. Treatment was divided into phases which included removal of impacted canine , lengthening of the maxillary and mandibular clinical crowns , and placement of anterior and posterior crowns.

  11. Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1)

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    Blinder, Kevin J; Dugel, Pravin U; Chen, Sanford; Jumper, J Michael; Walt, John G; Hollander, David A; Scott, Lanita C

    2017-01-01

    Purpose To evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF) inhibitors as used in clinical practice for the treatment of diabetic macular edema. Methods Multicenter (10 sites), retrospective chart review in patients (n=156) who received ≥3 anti-VEGF injections. Data collected for ≥6 months after the first injection included Snellen best-corrected visual acuity (BCVA) and central retinal thickness (CRT) by time-domain or spectral-domain optical coherence tomography (TD-OCT or SD-OCT). Results Mean number of anti-VEGF injections (627 bevacizumab, 594 ranibizumab, 1 aflibercept) was 5.8 (year 1), 5.0 (year 2), and 3.4 (year 3). Percentage of patients with BCVA of 20/40 or better and CRT ≤250 μm on TD-OCT or ≤300 μm on SD-OCT at the same visit (primary endpoint) ranged from 16.4% to 38.9% after the first 10 injections; 51.9%–62.3% achieved ≥20/40 BCVA and 26.2%–48.0% met CRT criteria. Therapy was well tolerated with 19 treatment-related adverse events (all ocular) reported. Conclusion Anti-VEGF injections were administered less frequently and were less effective than those in the ranibizumab registration trials. After each of the first 9 injections, <25% of patients achieved both BCVA of 20/40 or better and a dry macula. A substantial proportion of patients are suboptimal responders to anti-VEGF therapy; these patients may be candidates for other therapies, including intravitreal corticosteroid and laser therapy.

  12. The effects of anger and sadness on clinical pain reports and experimentally-induced pain thresholds in women with and without fibromyalgia.

    NARCIS (Netherlands)

    Middendorp, H. van; Lumley, M.A.; Jacobs, J.W.G.; Bijlsma, J.W.J.; Geenen, R.

    2010-01-01

    OBJECTIVE: Negative emotions are commonly experienced in fibromyalgia and may affect pain. This study examined the effects of anger and sadness on clinical pain reports and on pain threshold and tolerance in response to electrical stimulation in women with and without fibromyalgia. METHODS: In an ex

  13. The effects of anger and sadness on clinical pain reports and experimentally-induced pain thresholds in women with and without fibromyalgia.

    NARCIS (Netherlands)

    Middendorp, H. van; Lumley, M.A.; Jacobs, J.W.G.; Bijlsma, J.W.J.; Geenen, R.

    2010-01-01

    OBJECTIVE: Negative emotions are commonly experienced in fibromyalgia and may affect pain. This study examined the effects of anger and sadness on clinical pain reports and on pain threshold and tolerance in response to electrical stimulation in women with and without fibromyalgia. METHODS: In an

  14. Anti-VEGF treatment of diabetic macular edema in clinical practice: effectiveness and patterns of use (ECHO Study Report 1

    Directory of Open Access Journals (Sweden)

    Blinder KJ

    2017-02-01

    Full Text Available Kevin J Blinder,1 Pravin U Dugel,2,3 Sanford Chen,4 J Michael Jumper,5 John G Walt,6 David A Hollander,6 Lanita C Scott6 On behalf of the ECHO Study Group 1The Retina Institute, St Louis, MO, 2Retinal Consultants of Arizona, Phoenix, AZ, 3USC Roski Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, 4Orange County Retina, Santa Ana, 5West Coast Retina Medical Group, San Francisco, 6Allergan plc, Irvine, CA, USA Purpose: To evaluate the efficacy, safety, and injection frequency of vascular endothelial growth factor (VEGF inhibitors as used in clinical practice for the treatment of diabetic macular edema.Methods: Multicenter (10 sites, retrospective chart review in patients (n=156 who received ≥3 anti-VEGF injections. Data collected for ≥6 months after the first injection included Snellen best-corrected visual acuity (BCVA and central retinal thickness (CRT by time-domain or spectral-domain optical coherence tomography (TD-OCT or SD-OCT.Results: Mean number of anti-VEGF injections (627 bevacizumab, 594 ranibizumab, 1 aflibercept was 5.8 (year 1, 5.0 (year 2, and 3.4 (year 3. Percentage of patients with BCVA of 20/40 or better and CRT ≤250 µm on TD-OCT or ≤300 µm on SD-OCT at the same visit (primary endpoint ranged from 16.4% to 38.9% after the first 10 injections; 51.9%–62.3% achieved ≥20/40 BCVA and 26.2%–48.0% met CRT criteria. Therapy was well tolerated with 19 treatment-related adverse events (all ocular reported.Conclusion: Anti-VEGF injections were administered less frequently and were less effective than those in the ranibizumab registration trials. After each of the first 9 injections, <25% of patients achieved both BCVA of 20/40 or better and a dry macula. A substantial proportion of patients are suboptimal responders to anti-VEGF therapy; these patients may be candidates for other therapies, including intravitreal corticosteroid and laser therapy. Keywords: bevacizumab, diabetic

  15. Effects of the Combined Therapy of Acupuncture with Herbal Drugs on Male Immune Infertility-- A Clinical Report of 50 Cases

    Institute of Scientific and Technical Information of China (English)

    Fu Bing; Lun Xin; Gong Yuzhuo; Wang Xinzhong

    2005-01-01

    To study the clinical effects of the combined therapy of acupuncture with herbal drugs on male immune infertility and on antisperm antibody (AsAb), 100 male cases of infertility with positive AsAb were divided randomly into two groups, each consisting of 50 cases. The acupuncture-drug group was treated with acupuncture on Ganshu (BL 18), Shenshu (BL 23), Taichong (LR 3), Taixi (KI 3), Xinshu (BL 15),Geshu (BL 17), Shenmen (HT 7), and Xuehai (SP 10), combined with oral medication of Liuwei treated with oral prednisone. The clinical therapeutic effects and the impact on AsAb were observed in the two groups. The results showed that the total effective rate in the acupuncture-drug group was 90%;while that of the control group was 64%, the comparison showing a statistically significant difference (P<0.05). The positive rate of blood serum and/or AsAb in both the two groups decreased in varying degrees, but the negative-turning rate of AsAb in the acupuncture-drug group was more obvious, the comparison showing also a significant difference (P<0.05). Conclusion: The combined therapy of acupuncture with herbal drugs has definite therapeutic effects on male immune infertility, which can regulate AsAb and raise the immunity of the patients.

  16. PROPAFENONE, A NEW EFFECTIVE ANTIARRHYTHMIC DRUG. REPORT OF 2 YEARS CLINICAL EXPERIMENT WITH PROPAFENONE (WITH BRIEF REVIEW OF ARTICLES

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    IRAJ NAZERY

    1986-05-01

    Full Text Available Propafenone HCI (p, is a relatively new Class IC antiarrhythmic agent. It has been reported to be superior to conventional antiarrhythmics in the control of supraventricular, ventricular and WPW associated tachyarrhythmias. It has been also shown to be well tolerated. In our study protocol, which extends over 2~ years period , we used (p in 87 patients for management of various types of cardiac arrhythmias (most of whom were resistant to conventmonal antiarrhythmics . Intravenously administered, (P was effective in 85% of patients with paroxysmal reentrant supraventricular tachycardia (PRSVT, 75% of those with paroxysmal atrial fibrillation (PAF , 50% and 42% of those with refractory premature ventricular contractions (PVC and ventricular tachycardia (V. Tach, respectively. Orally administered, (P was effective in 73% of those with resistant PVCs and nonsustained ventricular tachycardia (NSV Tach, and 75% of those with resistant sustained ventricular tachycardia (RSVT •

  17. Expert systems for clinical pathology reporting.

    Science.gov (United States)

    Edwards, Glenn A

    2008-08-01

    * Conventional automated interpretative reporting systems use standard or "canned" comments for patient reports. These are result-specific and do not generally refer to the patient context. * Laboratory information systems (LIS) are limited in their application of patient-specific content of reporting. * Patient-specific interpretation requires extensive cross-referencing to other information contained in the LIS such as previous test results, other related tests, and clinical notes, both current and previous. * Expert systems have the potential to improve reporting quality by enabling patient-specific reporting in clinical laboratories.

  18. Developing Effective Clinical Trainers

    Directory of Open Access Journals (Sweden)

    Kevin Khamarko

    2012-05-01

    Full Text Available Continuing education and training provides a means to improve performance among health care professionals (HCP. Research shows, however, that continuing professional education activities have inconsistent effects on HCP competence, performance, and patient health outcomes. Furthermore, the trainer’s role as a facilitator of knowledge translation (KT has been understudied. To understand how clinical trainers support their trainees in translating what they learned into practice, we conducted 16 in-depth interviews with expert trainers. These interviews yielded a variety of KT-enhancing strategies, including tailoring training activities to their trainees’ needs. In addition, participants recommended trainers familiarize themselves with their trainees’ work environments, be able to identify their knowledge deficits, and devote time to provide trainees with post-training support. Creating an effective training, one that leads to transfer, requires active planning, communication, and command of the training topic by skilled trainers.

  19. Effects of clinical breakpoint changes in CLSI guidelines 2010/2011 and EUCAST guidelines 2011 on antibiotic susceptibility test reporting of Gram-negative bacilli.

    Science.gov (United States)

    Hombach, Michael; Bloemberg, Guido V; Böttger, Erik C

    2012-03-01

    The aim of this study was to analyse the effects of clinical breakpoint changes in CLSI 2010 and 2011 guidelines and EUCAST 2011 guidelines on antibiotic susceptibility testing (AST) reports. In total, 3713 non-duplicate clinical isolates of Enterobacteriaceae, Pseudomonas aeruginosa, Stenotrophomonas maltophilia and Acinetobacter baumannii were analysed. Inhibition zone diameters were determined for β-lactams, carbapenems, fluoroquinolones, aminoglycosides and trimethoprim/sulfamethoxazole. CLSI 2009-11 and EUCAST 2011 clinical breakpoints were applied. Changes in resistance as defined per the guidelines affected individual species and drug classes differently. The cefepime resistance rate in Escherichia coli and Enterobacter cloacae increased from 2.1% and 1.3% to 8.2% and 6.9%, respectively, applying CLSI 2009-11 versus EUCAST 2011 guidelines. Ertapenem resistance rates in E. cloacae increased from 2.6% with CLSI 2009 to 7.2% for CLSI 2010 and 2011, and to 10.1% when applying EUCAST 2011. Cefepime and meropenem resistance rates in P. aeruginosa increased from 12.2% and 20.6% to 19.8% and 27.7%, respectively, comparing CLSI 2009-11 with EUCAST 2011. Tobramycin and gentamicin resistance rates in A. baumannii increased from 15.9% and 25.4% to 34.9% and 44.4% applying CLSI 2009-11 versus EUCAST 2011. Higher resistance rates reported due to breakpoint changes in CLSI and EUCAST guidelines will result in increasing numbers of Gram-negative bacilli reported as multidrug resistant. AST reports classifying amoxicillin/clavulanic acid, cefepime or carbapenem resistance will lead clinicians to use alternative agents. Upon implementation of the EUCAST guidelines, laboratories should be aware of the implications of modified drug susceptibility testing reports on antibiotic prescription policies.

  20. Clinical report writing: Process and perspective

    Science.gov (United States)

    Ewald, H. R.

    1981-01-01

    Clinical report writing in psychology and psychiatry is addressed. Audience/use analysis and the basic procedures of information gathering, diagnosis, and prognosis are described. Two interlinking processes are involved: the process of creation and the process of communication. Techniques for good report writing are presented.

  1. Clinical effects of sulphite additives.

    Science.gov (United States)

    Vally, H; Misso, N L A; Madan, V

    2009-11-01

    Sulphites are widely used as preservative and antioxidant additives in the food and pharmaceutical industries. Topical, oral or parenteral exposure to sulphites has been reported to induce a range of adverse clinical effects in sensitive individuals, ranging from dermatitis, urticaria, flushing, hypotension, abdominal pain and diarrhoea to life-threatening anaphylactic and asthmatic reactions. Exposure to the sulphites arises mainly from the consumption of foods and drinks that contain these additives; however, exposure may also occur through the use of pharmaceutical products, as well as in occupational settings. While contact sensitivity to sulphite additives in topical medications is increasingly being recognized, skin reactions also occur after ingestion of or parenteral exposure to sulphites. Most studies report a 3-10% prevalence of sulphite sensitivity among asthmatic subjects following ingestion of these additives. However, the severity of these reactions varies, and steroid-dependent asthmatics, those with marked airway hyperresponsiveness, and children with chronic asthma, appear to be at greater risk. In addition to episodic and acute symptoms, sulphites may also contribute to chronic skin and respiratory symptoms. To date, the mechanisms underlying sulphite sensitivity remain unclear, although a number of potential mechanisms have been proposed. Physicians should be aware of the range of clinical manifestations of sulphite sensitivity, as well as the potential sources of exposure. Minor modifications to diet or behaviour lead to excellent clinical outcomes for sulphite-sensitive individuals.

  2. [Report of an amyopathic dermatomyositis clinical case].

    Science.gov (United States)

    Monteiro, Paulo; Duarte, Cátia; Salvador, Maria João; Malcata, Armando

    2009-01-01

    The authors report a clinical case of a 41-years-old man with astenia and myalgias maintained for many years without an accurate diagnosis. Amyopathic dermatomyositis was diagnosed based on the presence of typical cutaneous lesions and the absence of myositis. Subsequent evidence of subclinical myositis allowed the diagnosis of hypomyophatic dermatomyositis. Finally, the diagnosis of classical dermatomyositis could be made when the patient presented elevated levels of muscle enzimes. There was a good clinical response to imunossupressor therapy and the patient remains asymptomatic. Differences in the clinical management of amyopathic, hypomyopathic and classic dermatomyositis are discussed.

  3. Assessing clinical competency: reports from discussion groups.

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    Turnwald, Grant; Stone, Elizabeth; Bristol, David; Fuentealba, Carmen; Hardie, Lizette; Hellyer, Peter; Jaeger, Laurie; Kerwin, Sharon; Kochevar, Deborah; Lissemore, Kerry; Olsen, Christopher; Rogers, Kenita; Sabin, Beth; Swanson, Cliff; Warner, Angeline

    2008-01-01

    This report describes proposed new models for assessment of eight of the nine clinical competencies the American Veterinary Medical Association Council on Education requires for accreditation. The models were developed by discussion groups at the Association of American Veterinary Medical Colleges' Clinical Competency Symposium. Clinical competencies and proposed models (in parentheses) are described. Competency 1: comprehensive patient diagnosis (neurologic examination on a dog, clinical reasoning skills); Competency 2: comprehensive treatment planning (concept mapping, computerized case studies); Competency 3: anesthesia, pain management (student portfolio); Competency 4: surgery skills (objective structured clinical examination, cased-based examination, "super dog" model); Competency 5: medicine skills (clinical reasoning and case management, skills checklist); Competency 6: emergency and intensive care case management (computerized case study or scenario); Competency 7: health promotion, disease prevention/biosecurity (360 degrees evaluation, case-based computer simulation); Competency 8: client communications and ethical conduct (Web-based evaluation forms, client survey, communicating with stakeholders, telephone conversation, written scenario-based cases). The report also describes faculty recognition for participating in clinical competency assessments.

  4. Summary reports for key Hoodia clinical studies

    CSIR Research Space (South Africa)

    Maharaj, VJ

    2011-12-01

    Full Text Available The CSIR has acquired the reports to 14 clinical studies in which Hoodia has been assesses, using crude extracts and concentrated active ingredients formulated in a number of different ways. In many of the studies Hoodia was found to be generally...

  5. Unsupervised grammar induction of clinical report sublanguage

    Directory of Open Access Journals (Sweden)

    Kate Rohit J

    2012-10-01

    Full Text Available Abstract Background Clinical reports are written using a subset of natural language while employing many domain-specific terms; such a language is also known as a sublanguage for a scientific or a technical domain. Different genres of clinical reports use different sublaguages, and in addition, different medical facilities use different medical language conventions. This makes supervised training of a parser for clinical sentences very difficult as it would require expensive annotation effort to adapt to every type of clinical text. Methods In this paper, we present an unsupervised method which automatically induces a grammar and a parser for the sublanguage of a given genre of clinical reports from a corpus with no annotations. In order to capture sentence structures specific to clinical domains, the grammar is induced in terms of semantic classes of clinical terms in addition to part-of-speech tags. Our method induces grammar by minimizing the combined encoding cost of the grammar and the corresponding sentence derivations. The probabilities for the productions of the induced grammar are then learned from the unannotated corpus using an instance of the expectation-maximization algorithm. Results Our experiments show that the induced grammar is able to parse novel sentences. Using a dataset of discharge summary sentences with no annotations, our method obtains 60.5% F-measure for parse-bracketing on sentences of maximum length 10. By varying a parameter, the method can induce a range of grammars, from very specific to very general, and obtains the best performance in between the two extremes.

  6. Clinical effects of posterior pedicle screw fixation on spinal deformity in growing period: a report of 360 cases

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    Zheng-lei WANG

    2011-08-01

    Full Text Available Objective To observe the effect of a new kind of pedicle screw frame system with sliding terminus and locked middle segment on spinal deformity in growing period.Methods Three hundred and sixty patients in growing period were involved in the present study,and among them 82 were suffering from congenital scoliosis,218 idiopathic scoliosis and 60 kyphosis.All the patients were treated with the pedicle screw frame system with sliding terminus and locked middle segment.The treatment effects and postoperative complications were observed,and the Cobb angle before and after the operation was compared.Results The Cobb angle of 300 scoliosis patients was corrected from 53°±3° to 8°±2°,and the Cobb angle of 60 kyphosis patients was corrected from 60°±2° to 25°±3°,and the corrective effect was satisfactory.The correction rate of patients with Cobb angle ≤50° was 80%.Two hundred and ten patients were followed-up for 1 to 6 years,and the longitudinal growth of spine was 1.5-4.0cm.No severe complication,such as screw fracture,rod fracture or nerve injury,occurred.Conclusion The pedicle screw frame system with sliding terminus had a favorable three-dimensional correction effect,and the spine growth would not be restricted,and there was no stiffness,vertebral rotation,or distortion of shaft after operation.

  7. Dentine in a capsule: Clinical case reports

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    Mallikarjuna Kenchappa

    2015-01-01

    Full Text Available Biodentine TM , a calcium silicate based material has been popular now and can be used as an alternative to mineral trioxide aggregate (MTA due to superior physical and biologic properties. It has been known by several terms as Biodentine, dentin substitute, and RD 94. It has varied clinical applications such as apexification, apexogenesis, pulpotomy, internal resorption, root perforation repair, retrograde filling, pulp capping procedure, and dentin replacement. This article describes the clinical case reports using Biodentine in apexification, apexogenesis, pulpotomy, and root perforation repair.

  8. Visual Acuity Reporting in Clinical Research Publications.

    Science.gov (United States)

    Tsou, Brittany C; Bressler, Neil M

    2017-06-01

    Visual acuity results in publications typically are reported in Snellen or non-Snellen formats or both. A study in 2011 suggested that many ophthalmologists do not understand non-Snellen formats, such as logarithm of the Minimum Angle of Resolution (logMAR) or Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores. As a result, some journals, since at least 2013, have instructed authors to provide approximate Snellen equivalents next to non-Snellen visual acuity values. To evaluate how authors currently report visual acuity and whether they provide Snellen equivalents when their reports include non-Snellen formats. From November 21, 2016, through December 14, 2016, one reviewer evaluated visual acuity reporting among all articles published in 4 ophthalmology clinical journals from November 2015 through October 2016, including 3 of 4 journals that instructed authors to provide Snellen equivalents for visual acuity reported in non-Snellen formats. Frequency of formats of visual acuity reporting and frequency of providing Snellen equivalents when non-Snellen formats are given. The 4 journals reviewed had the second, fourth, fifth, and ninth highest impact factors for ophthalmology journals in 2015. Of 1881 articles reviewed, 807 (42.9%) provided a visual acuity measurement. Of these, 396 (49.1%) used only a Snellen format; 411 (50.9%) used a non-Snellen format. Among those using a non-Snellen format, 145 (35.3%) provided a Snellen equivalent while 266 (64.7%) provided only a non-Snellen format. More than half of all articles in 4 ophthalmology clinical journals fail to provide a Snellen equivalent when visual acuity is not in a Snellen format. Since many US ophthalmologists may not comprehend non-Snellen formats easily, these data suggest that editors and publishing staff should encourage authors to provide Snellen equivalents whenever visual acuity data are reported in a non-Snellen format to improve ease of understanding visual acuity measurements.

  9. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial.

    Science.gov (United States)

    Fernández-de-Las-Peñas, César; Cleland, Joshua; Palacios-Ceña, María; Fuensalida-Novo, Stella; Pareja, Juan A; Alonso-Blanco, Cristina

    2017-03-01

    Study Design Randomized parallel-group trial. Background Carpal tunnel syndrome (CTS) is a common pain condition that can be managed surgically or conservatively. Objective To compare the effectiveness of manual therapy versus surgery for improving self-reported function, cervical range of motion, and pinch-tip grip force in women with CTS. Methods In this randomized clinical trial, 100 women with CTS were randomly allocated to either a manual therapy (n = 50) or a surgery (n = 50) group. The primary outcome was self-rated hand function, assessed with the Boston Carpal Tunnel Questionnaire. Secondary outcomes included active cervical range of motion, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire. Patients were assessed at baseline and 1, 3, 6, and 12 months after the last treatment by an assessor unaware of group assignment. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores. Results At 12 months, 94 women completed the follow-up. Analyses showed statistically significant differences in favor of manual therapy at 1 month for self-reported function (mean change, -0.8; 95% confidence interval [CI]: -1.1, -0.5) and pinch-tip grip force on the symptomatic side (thumb-index finger: mean change, 2.0; 95% CI: 1.1, 2.9 and thumb-little finger: mean change, 1.0; 95% CI: 0.5, 1.5). Improvements in self-reported function and pinch grip force were similar between the groups at 3, 6, and 12 months. Both groups reported improvements in symptom severity that were not significantly different at all follow-up periods. No significant changes were observed in pinch-tip grip force on the less symptomatic side and in cervical range of motion in either group. Conclusion Manual therapy and surgery had similar effectiveness for improving self-reported function, symptom severity, and pinch-tip grip force on the symptomatic hand in women with CTS. Neither manual therapy nor surgery resulted

  10. Cannabis its clinical effects

    African Journals Online (AJOL)

    may be enhanced and short-term memory and judgement may be impaired. These effects ... realisation, a sense of loss of control, fear of dying, panic reactions and ... A mild withdrawal state from long-term use has been described. It consists ...

  11. Effect size in clinical phonology

    OpenAIRE

    GIERUT, JUDITH A.; Morrisette, Michele L.

    2011-01-01

    The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and evaluation of generalization learning, both of which are key to experimental studies in clinical phonology.

  12. Utilization and utility of clinical laboratory reports with graphical elements

    Directory of Open Access Journals (Sweden)

    Brian H Shirts

    2012-01-01

    Full Text Available Background: Graphical reports that contain charts, images, and tables have potential to convey information more effectively than text-based reports; however, studies have not measured how much clinicians value such features. We sought to identify factors that might influence the utilization of reports with graphical elements postulating that this is a surrogate for relative clinical utility of these graphical elements. Materials and Methods: We implemented a pilot project at ARUP laboratories to develop online enhanced laboratory test reports that contained graphical elements. We monitored on-demand clinician access to reports generated for 48 reportable tests over 22 months. We evaluated utilization of reports with graphical elements by clinicians at all institutions that use ARUP as a reference laboratory using descriptive statistics, regression, and meta-analysis tools to evaluate groups of similar test reports. Results: Median download rate by test was 8.6% with high heterogeneity in download rates between tests. Test reports with additional graphical elements were not necessarily downloaded more often than reports without these elements. Recently implemented tests and tests reporting abnormal results were associated with higher download rates (P < 0.01. Higher volume tests were associated with lower download rates (P = 0.03. Conclusions: In select cases graphical information may be clinically useful, particularly for less frequently ordered tests and in on reports of abnormal results. The utilization data presented could be used as a reference point for other laboratories planning on implementing graphical reporting. However, between-test heterogeneity was high and in many cases graphical elements may add little clinical utility, particularly if these merely reinforce information already contained in text based reports.

  13. Clinical pearls: factors affecting reported contraceptive efficacy rates in clinical studies.

    Science.gov (United States)

    Burkman, Ronald T

    2002-01-01

    Current combination oral contraceptives (OCs) are among the most popular, safe, and effective methods of reversible contraception. There are, however, many factors that can affect contraceptive failure rates as reported in clinical trials, including subject characteristics, factors related to study methodology and data analysis, and publication biases. The variability of these factors among clinical trials makes meaningful comparisons of contraceptive efficacy data across studies difficult, if not misleading or erroneous. It is even more difficult to reconcile the differences between clinical trial efficacy rates and everyday use rates; for instance, the National Survey of Family Growth reported that the rate of OC failure is close to 8% in the United States, which is higher than rates reported in clinical trials. Thus, it is important for the clinician to consider the many factors that can influence reporting of contraceptive failure rates in clinical trials and be aware of the limitations in differentiating OCs on the basis of contraceptive efficacy derived from clinical trial data. Furthermore, clinical trial data may not accurately predict contraceptive efficacy in everyday use.

  14. Clinical crown lengthening - a case report.

    Science.gov (United States)

    Lipska, Weronika; Lipski, Marcin; Lisiewicz, Małgorzata; Gala, Andrzej; Gronkiewicz, Krzysztof; Darczuk, Dagmara; Chomyszyn-Gajewska, Maria

    2015-01-01

    Maintaining healthy parodontium during teeth restoration procedures is an indispensable condition for obtain- ing regular functionning and esthetics. Thus, the knowledge of correct anatomy and the influence of filling and complement on paradontium tissue is vital. Difficulty in maintaining appropriate gingival biological width (GBW) is a frequent problem encountered in this type of reconstruction. Preservation of unchanged biological width conditions predictible treatment result and, what is more, lack of inflammatory lesions in marginal parodontium. The ideal situation for parodontium is localizing the filling/complement border supragingivaly, which is at least 3 mm from alveolar process edge. In the case, when the above conditions are impossible to fulfil, elongation of clinical crown is a metod of choice. The effect is possible to achieve by surgical treatment or combined orthodontic - surgical treatment. Surgical treatment is faster and preferred procedure for indirect reconstruction, where achieving high clinical crown is necessary. Three clinical cases of performing method of surgical clinical crown elongation were presented in the article. Performing the described procedure enables correct tooth crown reconstruction and, what is most important, keeping individual toothing.

  15. Anchoring and Publicity Effects in Clinical Judgment.

    Science.gov (United States)

    Friedlander, Myrna L.; Stockman, Susan J.

    1983-01-01

    Tested anchoring and publicity effects in clinicians' (N=46) successive judgments of detailed interview notes. Results indicated significant anchoring in one case suggesting a clinical bias. Public justification was related neither to subjects' ratings, to reported confidence in their ratings, nor differentially by case. (JAC)

  16. Effect Size in Clinical Phonology

    Science.gov (United States)

    Gierut, Judith A.; Morrisette, Michele L.

    2011-01-01

    The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and…

  17. Effect Size in Clinical Phonology

    Science.gov (United States)

    Gierut, Judith A.; Morrisette, Michele L.

    2011-01-01

    The purpose of this article is to motivate the use of effect size (ES) for single-subject research in clinical phonology, with an eye towards meta-analyses of treatment effects for children with phonological disorders. Standard mean difference (SMD) is introduced and illustrated as one ES well suited to the multiple baseline (MBL) design and…

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

    Science.gov (United States)

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

    2013-01-01

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

  19. [Proceedings: The clinical effects of human growth hormone. Report on an international symposium of the German Kabi Corp. on February 15, 1975 in Munich].

    Science.gov (United States)

    Butenandt, O

    1975-09-11

    Report of an International Symposion (Febr. 15, 1975, Munich). Human growth hormone (HGH) acts on proliferation of cartilage, the basal process of growth, by the way of somatomedine and changes in protein metabolism. Growth can be enhanced in hypopituitary dwardism and with higher dosage in other forms of failure to thrive. HGH also seems to have a beneficial effect in patients with muscular dystrophy as shown in a preliminary report but not in thrombocytopenia. First observations on patients with osteogenesis imperfecta and on patients with non healing fractures of the long bones (pseudarthroses) have shown significant improvement. Of importance are the reports on stopping severe gastric hemorrhage in patients with stress ulcera.

  20. Latex allergy in dentistry: clinical cases report

    NARCIS (Netherlands)

    Raggio, D.P.; Camargo, L.B.; Naspitz, G.M.C.C.; Politano, G.T.; Bonifacio, C.C.; Mendes, F.M.; Kierstman, F.

    2010-01-01

    Generally natural rubber latex (NRL) allergy is detected after some exposition to the material. As NRL is commonly found in different materials used daily in dental clinic, the allergy can be manifested in the pediatric dentistry clinic. The first clinical manifestation can be smooth but also severe

  1. Latex allergy in dentistry: clinical cases report

    NARCIS (Netherlands)

    Raggio, D.P.; Camargo, L.B.; Naspitz, G.M.C.C.; Politano, G.T.; Bonifacio, C.C.; Mendes, F.M.; Kierstman, F.

    2010-01-01

    Generally natural rubber latex (NRL) allergy is detected after some exposition to the material. As NRL is commonly found in different materials used daily in dental clinic, the allergy can be manifested in the pediatric dentistry clinic. The first clinical manifestation can be smooth but also

  2. Antiphospholipid Syndrome Clinical Research Task Force Report

    NARCIS (Netherlands)

    Erkan, D.; Derksen, R.; Levy, R.; Machin, S.; Ortel, T.; Pierangeli, S.; Roubey, R.; Lockshin, M.

    2011-01-01

    The Antiphospholipid Syndrome (APS) Clinical Research Task Force (CRTF) was one of six Task Forces developed by the 13(th) International Congress on Antiphospholipid Antibodies (aPL) organization committee with the purpose of: a) evaluating the limitations of APS clinical research and developing gui

  3. Ethics of safety reporting of a clinical trial

    Directory of Open Access Journals (Sweden)

    Amrita Sil

    2017-01-01

    Full Text Available Clinical trial related injury and serious adverse events (SAE are a major area of concern. In all such scenarios the investigator is responsible for medical care of the trial participant and also ethically bound to report the event to all the stakeholders of the clinical trial. The trial sponsor is responsible for ongoing safety evaluation of the investigational product, reporting and compensating the participant in case of any SAE. The Ethics Committee and regulatory body of the country are to uphold the ethical principles of beneficence, justice, non-maleficence in such cases. Any unwanted and noxious effect of a drug when used in recommended doses is an adverse drug reaction (ADR whereas if causal association is not yet established it is termed adverse event (AE. An AE or ADR that is associated with death, in-patient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, a congenital anomaly, or is otherwise life threatening is termed as an SAE. The principal investigator reports the event to the licensing authority (DCGI, sponsor and Chairperson of the Ethics Committee (EC within 24 hours of occurrence of the SAE. This report is furthered by a detailed report by both the investigator and the EC and given to the DCGI who then gives a final decision on the amount of compensation to be given by the sponsor or the sponsor's representative to the grieving party.

  4. Characteristics of effective clinical teachers.

    Science.gov (United States)

    Buchel, Tamara L; Edwards, Frederick D

    2005-01-01

    Defining what makes an exceptional teacher is challenging. This study's objectives were to identify teaching attributes that residents and faculty value most and to determine whether the opinions of residents and faculty differed. A list of 15 teaching attributes was distributed to residents and faculty at eight family medicine residency programs. Respondents were asked to indicate the three most important and the three least important attributes of effective clinical educators. Overall response rates were 58% for residents and 65% for faculty. Residents and faculty agreed that being enthusiastic and having clinical competence are important attributes and that scholarly activity is not as important. Residents felt it is important for an educator to respect their autonomy and independence as clinicians, whereas faculty members felt that this was among the least important traits. Faculty felt that serving as a role model worth emulating was important, but residents ranked this at the bottom of their list. Residents placed a higher premium on a faculty member's ability to answer questions clearly and explain difficult topics (labeled "clarity" in our study) and felt more strongly that it was important for quality educators to be readily available and able to provide a safe, nonjudgmental, nonthreatening learning environment. There are areas of agreement and disagreement between faculty and residents about attributes of effective clinical teachers. With the implementation of competency-based assessment systems, it will become important to determine which attributes actually promote the development of competence among learners, thereby allowing the encouragement of those attributes.

  5. Community Mental Health Clinic Cost Reports

    Data.gov (United States)

    U.S. Department of Health & Human Services — Healthcare Cost Report Information System (HCRIS) Dataset - Community Mental Health Center (CMHC). This data was reported on form CMS-2088-92. The data in this...

  6. Clinical effectiveness of contemporary dentin bonding agents

    Science.gov (United States)

    Krithikadatta, Jogikalmat

    2010-01-01

    Aim: The purpose of this paper is to review the literature on the clinical effectiveness of contemporary resin-based dentin bonding agents primarily focussing on the longevity of restoration. Materials and Methods: The literature published from June 2004 up to September 2010 was reviewed for clinical trials that tested the effectiveness of dentin bonding agents in the longevity of noncarious class V restoration. Results of each study reported using the USPHS criteria for clinical assessment of restoration were included and tabulated. The American Dental Association guidelines for dentin and enamel adhesives were used as a reference to compare the performance of individual bonding agents. Kruskal–Wallis followed by Mann–Whitney U was done to compare the mean Alfa score percentage for the three categories of bonding systems [etch-and-rinse (ER), self-etch primer (SEP), and self-etch-adhesive (SEA)]. Results: A comparison of the mean Alfa score percentages revealed no difference between the ER, SEP, and SEA categories of bonding systems except for marginal adaptation where ER was found to be superior to SEA. Conclusion: The clinical effectiveness of resin-based bonding agents is comparable among the three categories. PMID:21217944

  7. Clinical Investigation Program. Annual Research Progress Report.

    Science.gov (United States)

    1980-09-30

    Stereoscope 79/118 $6149.00 Ion Generator 78/116 $5000.00 Poultry Cages 79/301 $2929.00 Microtome/Cryostat 79/304 $5494.72 Tissue Embedder 79/300... Mycology : Assessment of bacteriologic and seroligic parameters of clinically-important mycoses normal and immunologic comprised host. Presented: American

  8. [A rare clinical report of giant hemangiopericytoma].

    Science.gov (United States)

    Shkarubo, A N; Shishkina, L V; Tailakov, Sh T; Dorosh, K V; Khromov, A P

    2014-01-01

    Authors show an example of a successful treatment of a patient with a giant intracranial hemangiopericytoma. Hemangiopericytoma are aggressive tumors with a high rate of recurrence and metastasis. Despite the malignant nature of these tumors often reach a large size with minor clinical signs. Surgical removal of the tumor is still the primary method of treatment.

  9. Clinical Investigation Program Annual Progress Report.

    Science.gov (United States)

    1984-09-30

    Sarcoidosis Alveolitis I (12) Accumulative MEDCASE:’ (13) Est Accum OMA Cost:* *Refer to Unit Summary Sheet of this report. (14) a. Date, Latest HUC...182 alveolar gas ----------------------- 039 pressure ----------------------- 037 alveolitis -------------------------- 107 aminocaproic acid

  10. Modeling the longitudinal latent effect of pregabalin on self-reported changes in sleep disturbances in outpatients with generalized anxiety disorder managed in routine clinical practice

    Directory of Open Access Journals (Sweden)

    Ruiz MA

    2015-08-01

    Full Text Available Miguel A Ruiz,1 Enrique Álvarez,2 Jose L Carrasco,3 José M Olivares,4 María Pérez,5 Javier Rejas6 1Department of Methodology, School of Psychology, Universidad Autónoma de Madrid, Madrid, 2Department of Psychiatry, Hospital de la Santa Creu i San Pau, Barcelona, 3Department of Psychiatry, Hospital Clínico San Carlos, Madrid, 4Department of Psychiatry, Hospital Meixoeiro, Complejo Hospitalario Universitario, Vigo, 5Medical Department, Pfizer, S.L.U., Alcobendas, Madrid, 6Health Economics and Outcomes Research Department, Pfizer, S.L.U., Alcobendas, Madrid, Spain Background: Anxiety disorders are among the most common psychiatric illnesses, with generalized anxiety disorder (GAD being one of the most common. Sleep disturbances are highly prevalent in GAD patients. While treatment with pregabalin has been found to be associated with significant improvement in GAD-related sleep disturbance across many controlled clinical trials, mediational analysis has suggested that a substantial portion of this effect could be the result of a direct effect of pregabalin. Thus, the objective of this study was to model the longitudinal latent effect of pregabalin or usual care (UC therapies on changes in sleep in outpatients with GAD under routine clinical practice. Methods: Male and female GAD outpatients, aged 18 years or above, from a 6-month prospective noninterventional trial were analyzed. Direct and indirect effects of either pregabalin or UC changes in anxiety symptoms (assessed with Hamilton Anxiety Scale and sleep disturbances (assessed with Medical Outcomes Study-Sleep Scale [MOS-S] were estimated by a conditional latent curve model applying structural equation modeling. Results: A total of 1,546 pregabalin-naïve patients were analyzed, 984 receiving pregabalin and 562 UC. Both symptoms of anxiety and sleep disturbances were significantly improved in both groups, with higher mean (95% confidence interval score reductions in subjects receiving

  11. Uncaria tomentosa Gel against Denture Stomatitis: Clinical Report.

    Science.gov (United States)

    Tay, Lidia Y; Dos Santos, Fabio A; Jorge, Janaina H

    2015-02-09

    The objective of this study is to report the clinical use of 2% Uncaria tomentosa gel against denture stomatitis (DS) as an alternative treatment. The patient was a 65-year-old, denture-wearing woman. At the clinical examination, her palate showed hyperplasic and erythematous mucosa indicating DS type II. DS is a chronic oral disease that affects denture wearers. It occurs as an inflammatory reaction in denture-wearing patients under maxillary prostheses. Candida albicans has been reported as the principal etiological agent. An alternative treatment, the topical application of a gel of 2% U. tomentosa three times a day for 1 week was given to the patient. After 1 week of this treatment, she had significantly reduced signs of the disease. Despite the existence of a great number of antifungal agents, treatment failure is observed frequently. Phytotherapy is becoming more popular worldwide. Currently, the most promising medicinal Amazonian herb is U. tomentosa (Willd.) DC., known as Cat's Claw. Studies of the chemical and pharmacological properties of this medicinal plant have allowed researchers to develop indications for its use. This report demonstrates the effectiveness of U. tomentosa against DS. © 2015 by the American College of Prosthodontists.

  12. First report of oligodendroglioma in a sheep : clinical communication

    Directory of Open Access Journals (Sweden)

    A. Derakhshanfar

    2010-05-01

    Full Text Available Oligodendrogliomas occur most commonly in the dog, but have also been reported in cattle, horses and cats. A 1-year-old sheep with neurological disturbances, including blindness, ataxia, circling and incoordination was referred to the veterinary clinic of Shahid Bahonar University of Kerman. Following euthanasia and necropsy, a soft, relatively well-demarcated mass was observed in the white and grey matter of the right cerebral hemisphere, close to the sylvian fissure in the right cerebral hemisphere. Microscopic examination revealed a sheet of densely packed tumour cells with hyperchromatic nuclei, lightly staining cytoplasm and characteristic perinuclear halo effect which is consistent with a diagnosis of oligodendroglioma. This is the 1st report of oligodendroglioma in sheep.

  13. Prevalence of estimated GFR reporting among US clinical laboratories.

    Science.gov (United States)

    Accetta, Nancy A; Gladstone, Elisa H; DiSogra, Charles; Wright, Elizabeth C; Briggs, Michael; Narva, Andrew S

    2008-10-01

    Routine laboratory reporting of estimated glomerular filtration rate (eGFR) may help clinicians detect kidney disease. The current national prevalence of eGFR reporting in clinical laboratories is unknown; thus, the extent of the situation of laboratories not routinely reporting eGFR with serum creatinine results is not quantified. Observational analysis. National Kidney Disease Education Program survey of clinical laboratories conducted in 2006 to 2007 by mail, web, and telephone follow-up. A national random sample, 6,350 clinical laboratories, drawn from the Federal Clinical Laboratory Improvement Amendments database and stratified by 6 major laboratory types/groupings. Laboratory reports serum creatinine results. Reporting eGFR values with serum creatinine results. Percentage of laboratories reporting eGFR along with reporting serum creatinine values, reporting protocol, eGFR formula used, and style of reporting cutoff values. Of laboratories reporting serum creatinine values, 38.4% report eGFR (physician offices, 25.8%; hospitals, 43.6%; independents, 38.9%; community clinics, 47.2%; health fair/insurance/public health, 45.5%; and others, 43.2%). Physician office laboratories have a reporting prevalence lower than other laboratory types (P laboratories reporting eGFR, 66.7% do so routinely with all adult serum creatinine determinations; 71.6% use the 4-variable Modification of Diet in Renal Disease Study equation; and 45.3% use the ">60 mL/min/1.73 m(2)" reporting convention. Independent laboratories are least likely to routinely report eGFR (50.6%; P laboratories across all strata are more likely to report eGFR (P laboratories, federal database did not have names of laboratory directors/managers (intended respondents), assumed accuracy of federal database for sample purposes. Routine eGFR reporting with serum creatinine values is not yet universal, and laboratories vary in their reporting practices.

  14. Clinical effects of cesium intake.

    Science.gov (United States)

    Melnikov, Petr; Zanoni, Lourdes Zélia

    2010-06-01

    The knowledge about cesium metabolism and toxicity is sparse. Oral intake of cesium chloride has been widely promoted on the basis of the hypothesis referred to as "high pH cancer therapy", a complimentary alternative medicine method for cancer treatment. However, no properly confirmed tumor regression was reported so far in all probability because of neither theoretical nor experimental grounds for this proposal. The aim of the present review was to resume and discuss the material currently available on cesium salts and their applications in medicine. The presence of cesium in the cell does not guarantee high pH of its content, and there is no clinical evidence to support the claims that cancer cells are vulnerable to cesium. Cesium is relatively safe; signs of its mild toxicity are gastrointestinal distress, hypotension, syncope, numbness, or tingling of the lips. Nevertheless, total cesium intakes of 6 g/day have been found to produce severe hypokalemia, hypomagnesemia, prolonged QTc interval, episodes of polymorphic ventricular tachycardia, with or without torsade de pointes, and even acute heart arrest. However, full information on its acute and chronic toxicity is not sufficiently known. Health care providers should be aware of the cardiac complications, as a result of careless cesium usage as alternative medicine.

  15. Treatment of hyperkeratosis with Kerafoam emollient foam (30% urea) to assess effectiveness and safety within a clinical setting: a case study report.

    Science.gov (United States)

    Goldstein, Jay A; Gurge, Ronald M

    2008-02-01

    Ten patients enrolled in a single center, observational, prospective, open-label case study to assess the effectiveness and safety of a 28 day regimen with Kerafoam 30% urea emollient foam for treatment of hyperkeratosis. Clinician assessments of skin condition were recorded at baseline, day 14, and day 28. In addition, patients' ratings of the treatment impact on quality of life and skin condition, as well as overall satisfaction with the product were obtained. Key results demonstrated significant improvements in clinicians' ratings of skin condition at the day 14 and day 28 visits compared to baseline and significant improvements in patients' ratings of quality of life. No adverse events were reported and all patients completed the 28-day treatment regimen. Patient and clinician evaluations of the 30% urea emollient foam product were extremely favorable.

  16. Clinical and molecular effect on offspring of a marriage of consanguineous spinocerebellar ataxia type 7 mutation carriers: a family case report

    Science.gov (United States)

    Magaña, Jonathan J; Tapia-Guerrero, Yessica S; Velázquez-Pérez, Luis; Cruz-Mariño, Tania; Cerecedo-Zapata, Cesar M; Gómez, Rocío; Murillo-Melo, Nadia M; González-Piña, Rigoberto; Hernández-Hernández, Oscar; Cisneros, Bulmaro

    2014-01-01

    Spinocerebellar ataxia type 7 (SCA7) is a genetic disorder characterized by degeneration of the cerebellum, brainstem, and retina that is caused by abnormal expansion of a CAG repeat located in the ATXN7 gene encoding sequence on chromosome 3p21.1. Although SCA7 is an uncommon autosomal dominant ataxia, we previously found increased prevalence of the disease in a Southeastern Mexican population. In this study, we described to our knowledge for the first time a marriage of consanguineous SCA7 mutation carriers and their offspring effect. We characterized a severely affected infantile-onset female patient whose parents and two siblings exhibited no symptoms of the disease at time of diagnosis. A comprehensive clinical analysis of the proband showed a progressive cerebellar syndrome, including gait ataxia, movement disorders, and saccadic movements, as well as hyperreflexia, visual deterioration, urinary and cardiovascular dysfunction, and impaired nerve conduction. The SCA7 mutation was detected in the proband patient. Subsequently, genetic examination using four ATXN7 gene-linked markers (three centromeric microsatellite markers [D3S1228, D3S1287, and D3S3635] and an intragenic Single Nucleotide Polymorphism [SNP-3145G/A]) revealed that the proband descends from a couple of consanguineous SCA7 mutation carriers. Genotyping analysis demonstrated that all offspring inherited only one mutant allele, and that the severe infantile-onset phenotype is caused by germinal expansion (from 37 to 72 CAG repeats) of the paternal mutant allele. Interestingly, the couple also referred a miscarriage. Finally, we found no CAA interruptions in the ATXN7 gene CAG repeats tract in this family, which might explain, at least in part, the triplet instability in the proband. PMID:25664129

  17. Clinical Investigation Program Annual Progress Report

    Science.gov (United States)

    1989-09-30

    Aspen ( COMPRA ) Aspen, CO, July 1989. Carter BS, Anderson BA, Frank CG, Pierce JR: Military Neonatologists and Bioethical Decision Making. Presented...Conference on Military Perinatal Research at Aspen ( COMPRA ) Aspen, CO, July 1989. Frank CG: National Faculty/Course Instructor American Academy of...Membrane Disease. Presented: Conference on Military Perinatal Research at Aspen ( COMPRA ) Aspen, CO, July 1989. Kinsella JP: Cardiopulmonary Effects of

  18. Clinical Investigation Program Annual Progress Report.

    Science.gov (United States)

    1983-09-30

    Compliance Utilizing Pulmon - ary Capillary Wedge Pressures.(T) ................ 046 79/107 The Effects of Fructose on Reactive Hypoglycemia. (C)(P...052 . 80/103 Etoposide (VP-16-213) Single Agent Chemotherapy in Small Cell Lung Cancer Patients Refractory to First-line Chemotherapy. (T...Vincristine in the Treat- ment of Small Cell Lung Cancer .(O) ............... 054 80/108 Topical Cocaine for the Relief of Stomatitis in Patients with

  19. [Paraffinomas: history, clinical features and treatment. A case report].

    Science.gov (United States)

    Mounios-Perchenet, A S; Le Fourn, B; Hepner-Lavergne, D; Pannier, M

    1997-02-01

    One case of paraffinoma is reported on a 60 years old man following injections of paraffin fourty years ago. The authors recalled with this observation history of paraffin, clinical aspect and surgical treatment of the paraffinoma.

  20. Pregnancy in multiple sclerosis: clinical and self-report scales

    NARCIS (Netherlands)

    R.F. Neuteboom (Rinze); A.C.J.W. Janssens (Cécile); T.A.M. Siepman (Theodora); I.A. Hoppenbrouwers (Ilse); I.A. Ketelslegers (Immy); N. Jafari (Naghmeh); R.P.M. Steegers-Theunissen (Régine); C.J.M. de Groot (Christianne); R.Q. Hintzen (Rogier)

    2012-01-01

    textabstractRelapse rate is decreased during pregnancy in multiple sclerosis (MS). Risk for postpartum relapse is increased in the first 3 months after delivery. We aimed to study clinical course of MS around pregnancy, using clinical as well as self-report scales, including data on quality of life

  1. Methylene blue for clinical anaphylaxis treatment: a case report

    Directory of Open Access Journals (Sweden)

    Janine Moreira Rodrigues

    Full Text Available CONTEXT AND OBJECTIVE: Nitric oxide has a pathophysiological role in modulating systemic changes associated with anaphylaxis. Nitric oxide synthase inhibitors may exacerbate bronchospasm in anaphylaxis and worsen clinical conditions, with limited roles in anaphylactic shock treatment. The aim here was to report an anaphylaxis case (not anaphylactic shock, reversed by methylene blue (MB, a guanylyl cyclase inhibitor. CASE REPORT: A 23-year-old female suddenly presented urticaria and pruritus, initially on her face and arms, then over her whole body. Oral antihistamine was administered initially, but without improvement in symptoms and signs until intravenous methylprednisolone 500 mg. Recurrence occurred after two hours, plus vomiting. Associated upper respiratory distress, pulmonary sibilance, laryngeal stridor and facial angioedema (including erythema and lip edema marked the evolution. At sites with severe pruritus, petechial lesions were observed. The clinical situation worsened, with dyspnea, tachypnea, peroral cyanosis, laryngeal edema with severe expiratory dyspnea and deepening unconsciousness. Conventional treatment was ineffective. Intubation and ventilatory support were then considered, because of severe hypoventilation. But, before doing that, based on our previous experience, 1.5 mg/kg (120 mg bolus of 4% MB was infused, followed by one hour of continuous infusion of another 120 mg diluted in dextrose 5% in water. Following the initial intravenous MB dose, the clinical situation reversed completely in less than 20 minutes, thereby avoiding tracheal intubation. CONCLUSION: Although the nitric oxide hypothesis for MB effectiveness discussed here remains unproven, our intention was to share our accumulated cohort experience, which strongly suggests MB is a lifesaving treatment for anaphylactic shock and/or anaphylaxis and other vasoplegic conditions.

  2. American Clinical Neurophysiology Society Guideline 7: Guidelines for EEG Reporting.

    Science.gov (United States)

    Tatum, William O; Olga, Selioutski; Ochoa, Juan G; Munger Clary, Heidi; Cheek, Janna; Drislane, Frank; Tsuchida, Tammy N

    2016-08-01

    This EEG Guideline incorporates the practice of structuring a report of results obtained during routine adult electroencephalography. It is intended to reflect one of the current practices in reporting an EEG and serves as a revision of the previous guideline entitled "Writing an EEG Report." The goal of this guideline is not only to convey clinically relevant information, but also to improve interrater reliability for clinical and research use by standardizing the format of EEG reports. With this in mind, there is expanded documentation of the patient history to include more relevant clinical information that can affect the EEG recording and interpretation. Recommendations for the technical conditions of the recording are also enhanced to include post hoc review parameters and type of EEG recording. Sleep feature documentation is also expanded upon. More descriptive terms are included for background features and interictal discharges that are concordant with efforts to standardize terminology. In the clinical correlation section, examples of common clinical scenarios are now provided that encourages uniformity in reporting. Including digital samples of abnormal waveforms is now readily available with current EEG recording systems and may be beneficial in augmenting reports when controversial waveforms or important features are encountered.

  3. Basics of case report form designing in clinical research

    Directory of Open Access Journals (Sweden)

    Shantala Bellary

    2014-01-01

    Full Text Available Case report form (CRF is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

  4. Toward Improved Statistical Reporting in the Journal of Consulting and Clinical Psychology

    Science.gov (United States)

    Fidler, Fiona; Cumming, Geoff; Thomason, Neil; Pannuzzo, Dominique; Smith, Julian; Fyffe, Penny; Edmonds, Holly; Harrington, Claire; Schmitt, Rachel

    2005-01-01

    Philip Kendall's (1997) editorial encouraged authors in the Journal of Consulting and Clinical Psychology (JCCP) to report effect sizes and clinical significance. The present authors assessed the influence of that editorial--and other American Psychological Association initiatives to improve statistical practices--by examining 239 JCCP articles…

  5. Toward Improved Statistical Reporting in the Journal of Consulting and Clinical Psychology

    Science.gov (United States)

    Fidler, Fiona; Cumming, Geoff; Thomason, Neil; Pannuzzo, Dominique; Smith, Julian; Fyffe, Penny; Edmonds, Holly; Harrington, Claire; Schmitt, Rachel

    2005-01-01

    Philip Kendall's (1997) editorial encouraged authors in the Journal of Consulting and Clinical Psychology (JCCP) to report effect sizes and clinical significance. The present authors assessed the influence of that editorial--and other American Psychological Association initiatives to improve statistical practices--by examining 239 JCCP articles…

  6. Human reporter genes: potential use in clinical studies

    Energy Technology Data Exchange (ETDEWEB)

    Serganova, Inna [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Ponomarev, Vladimir [Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Blasberg, Ronald [Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States); Department of Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY 10021 (United States)], E-mail: blasberg@neuro1.mskcc.org

    2007-10-15

    The clinical application of positron-emission-tomography-based reporter gene imaging will expand over the next several years. The translation of reporter gene imaging technology into clinical applications is the focus of this review, with emphasis on the development and use of human reporter genes. Human reporter genes will play an increasingly more important role in this development, and it is likely that one or more reporter systems (human gene and complimentary radiopharmaceutical) will take leading roles. Three classes of human reporter genes are discussed and compared: receptors, transporters and enzymes. Examples of highly expressed cell membrane receptors include specific membrane somatostatin receptors (hSSTrs). The transporter group includes the sodium iodide symporter (hNIS) and the norepinephrine transporter (hNET). The endogenous enzyme classification includes human mitochondrial thymidine kinase 2 (hTK2). In addition, we also discuss the nonhuman dopamine 2 receptor and two viral reporter genes, the wild-type herpes simplex virus 1 thymidine kinase (HSV1-tk) gene and the HSV1-tk mutant (HSV1-sr39tk). Initial applications of reporter gene imaging in patients will be developed within two different clinical disciplines: (a) gene therapy and (b) adoptive cell-based therapies. These studies will benefit from the availability of efficient human reporter systems that can provide critical monitoring information for adenoviral-based, retroviral-based and lenteviral-based gene therapies, oncolytic bacterial and viral therapies, and adoptive cell-based therapies. Translational applications of noninvasive in vivo reporter gene imaging are likely to include: (a) quantitative monitoring of gene therapy vectors for targeting and transduction efficacy in clinical protocols by imaging the location, extent and duration of transgene expression; (b) monitoring of cell trafficking, targeting, replication and activation in adoptive T-cell and stem/progenitor cell therapies

  7. Reporting and evaluation of HIV-related clinical endpoints in two multicenter international clinical trials

    DEFF Research Database (Denmark)

    Lifson, A; Rahme, FS; Belloso, WH;

    2006-01-01

    PURPOSE: The processes for reporting and review of progression of HIV disease clinical endpoints are described for two large phase III international clinical trials. METHOD: SILCAAT and ESPRIT are multicenter randomized HIV trials evaluating the impact of interleukin-2 on disease progression...

  8. Teamwork and clinical error reporting among nurses in Korean hospitals.

    Science.gov (United States)

    Hwang, Jee-In; Ahn, Jeonghoon

    2015-03-01

    To examine levels of teamwork and its relationships with clinical error reporting among Korean hospital nurses. The study employed a cross-sectional survey design. We distributed a questionnaire to 674 nurses in two teaching hospitals in Korea. The questionnaire included items on teamwork and the reporting of clinical errors. We measured teamwork using the Teamwork Perceptions Questionnaire, which has five subscales including team structure, leadership, situation monitoring, mutual support, and communication. Using logistic regression analysis, we determined the relationships between teamwork and error reporting. The response rate was 85.5%. The mean score of teamwork was 3.5 out of 5. At the subscale level, mutual support was rated highest, while leadership was rated lowest. Of the participating nurses, 522 responded that they had experienced at least one clinical error in the last 6 months. Among those, only 53.0% responded that they always or usually reported clinical errors to their managers and/or the patient safety department. Teamwork was significantly associated with better error reporting. Specifically, nurses with a higher team communication score were more likely to report clinical errors to their managers and the patient safety department (odds ratio = 1.82, 95% confidence intervals [1.05, 3.14]). Teamwork was rated as moderate and was positively associated with nurses' error reporting performance. Hospital executives and nurse managers should make substantial efforts to enhance teamwork, which will contribute to encouraging the reporting of errors and improving patient safety. Copyright © 2015. Published by Elsevier B.V.

  9. Oral rehabilitation of severe dentoalveolar trauma: a clinical report.

    Science.gov (United States)

    Robinson, Fonda G; Cunningham, Larry L

    2012-12-01

    This clinical report describes the oral rehabilitation of an adult male who suffered severe dentoalveolar trauma as a result of a motor vehicle accident. The specific objectives of this treatment were to restore esthetics and masticatory function. Treatment included removal of fractured roots, placement of multiple endosseous implants, and placement of anterior and posterior metal-ceramic crowns and fixed partial dentures. Three year clinical examination revealed no pathology associated with the rehabilitation. The patient's esthetic and functional expectations were successfully achieved.

  10. Frequency of discrepancies in retracted clinical trial reports versus unretracted reports: blinded case-control study.

    Science.gov (United States)

    Cole, Graham D; Nowbar, Alexandra N; Mielewczik, Michael; Shun-Shin, Matthew J; Francis, Darrel P

    2015-09-20

    To compare the frequency of discrepancies in retracted reports of clinical trials with those in adjacent unretracted reports in the same journal. Blinded case-control study. Journals in PubMed. 50 manuscripts, classified on PubMed as retracted clinical trials, paired with 50 adjacent unretracted manuscripts from the same journals. Reports were randomly selected from PubMed in December 2012, with no restriction on publication date. Controls were the preceding unretracted clinical trial published in the same journal. All traces of retraction were removed. Three scientists, blinded to the retraction status of individual reports, reviewed all 100 trial reports for discrepancies. Discrepancies were pooled and cross checked before being counted into prespecified categories. Only then was the retraction status unblinded for analysis. Total number of discrepancies (defined as mathematically or logically contradictory statements) in each clinical trial report. Of 479 discrepancies found in the 100 trial reports, 348 were in the 50 retracted reports and 131 in the 50 unretracted reports. On average, individual retracted reports had a greater number of discrepancies than unretracted reports (median 4 (interquartile range 2-8.75) v 0 (0-5); Pretracted than those without a discrepancy (odds ratio 5.7 (95% confidence interval 2.2 to 14.5); Pretracted than unretracted reports: factual discrepancies (P=0.002), arithmetical errors (P=0.01), and missed P values (P=0.02). Results from a retrospective analysis indicated that citations and journal impact factor were unlikely to affect the result. Discrepancies in published trial reports should no longer be assumed to be unimportant. Scientists, blinded to retraction status and with no specialist skill in the field, identify significantly more discrepancies in retracted than unretracted reports of clinical trials. Discrepancies could be an early and accessible signal of unreliability in clinical trial reports. © Cole et al 2015.

  11. LIPAEMIC report: results of clinical use of intravenous lipid emulsion in drug toxicity reported to an online lipid registry.

    Science.gov (United States)

    Cave, Grant; Harvey, Martyn; Willers, Johann; Uncles, David; Meek, Tim; Picard, John; Weinberg, Guy

    2014-06-01

    The use of intravenous lipid emulsion (ILE) as an antidote has prompted significant academic and clinical interest. Between August 2009 and August 2012, data from cases of ILE use in intoxicated patients in different hospitals on different continents were voluntarily entered into a registry based on the world wide web (www.lipidregistry.org). Here, we report data from this project. Participating centers were given access to the registry following institutional subscription. Specifically sought were details of the individual patients' presenting condition, indications for ILE use, ILE administration regimen, potential complications, and of clinical outcome. Forty-eight uses of ILE were reported from 61 participating centers. Ten cases of local anesthetic systemic toxicity were reported; all (10/10) survived. Thirty-eight cases of intoxication by other agents were reported [30 decreased conscious state, 8 cardiovascular collapse (3 deaths)]. There was an elevation in GCS (p adverse effects of ILE use were recorded in 48 reported cases (one case of bronchospastic reaction, one case of hyperamylasemia and one case of interference with laboratory testing). In this series of cases reported to the registry, improvements were seen for GCS in patients with central nervous system toxicity and in systolic blood pressure in shocked patients over a short time frame after the injection of ILE. Few adverse effects were recorded. Clinical trials and the reporting of drug concentrations after ILE use are necessary to further elucidate the role of ILE in clinical toxicology.

  12. Compliance with results reporting at ClinicalTrials.gov.

    Science.gov (United States)

    Anderson, Monique L; Chiswell, Karen; Peterson, Eric D; Tasneem, Asba; Topping, James; Califf, Robert M

    2015-03-12

    The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results. Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period. From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions. Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic

  13. Errors in self-reports of health services use: impact on alzheimer disease clinical trial designs.

    Science.gov (United States)

    Callahan, Christopher M; Tu, Wanzhu; Stump, Timothy E; Clark, Daniel O; Unroe, Kathleen T; Hendrie, Hugh C

    2015-01-01

    Most Alzheimer disease clinical trials that compare the use of health services rely on reports of caregivers. The goal of this study was to assess the accuracy of self-reports among older adults with Alzheimer disease and their caregiver proxy respondents. This issue is particularly relevant to Alzheimer disease clinical trials because inaccuracy can lead both to loss of power and increased bias in study outcomes. We compared respondent accuracy in reporting any use and in reporting the frequency of use with actual utilization data as documented in a comprehensive database. We next simulated the impact of underreporting and overreporting on sample size estimates and treatment effect bias for clinical trials comparing utilization between experimental groups. Respondents self-reports have a poor level of accuracy with κ-values often below 0.5. Respondents tend to underreport use even for rare events such as hospitalizations and nursing home stays. In analyses simulating underreporting and overreporting of varying magnitude, we found that errors in self-reports can increase the required sample size by 15% to 30%. In addition, bias in the reported treatment effect ranged from 3% to 18% due to both underreporting and overreporting errors. Use of self-report data in clinical trials of Alzheimer disease treatments may inflate sample size needs. Even when adequate power is achieved by increasing sample size, reporting errors can result in a biased estimate of the true effect size of the intervention.

  14. "A Great First Step into Research": Stepping Into Research Is an Effective and Sustainable Model for Research Training in Clinical Settings: A Report of 6-Year Outcomes.

    Science.gov (United States)

    Harding, Katherine E; Shields, Nora; Whiteside, Mary; Taylor, Nicholas F

    2016-01-01

    Cultivating a dynamic research culture is critical to growing the allied health professions. The Stepping into Research training program was developed in 2008 using small group training and mentoring to train allied health clinicians at a large health service in basic research skills. This paper describes the outcomes 6 years after its implementation, including translation of the program to a second health service. This mixed-methods observational evaluation included (1) quantitative data on research outputs (publications, conference presentations- and enrolment in further research training) and (2) qualitative analysis of the experiences of the first cohort of participants following translation of the program to a second site, with comparison to a previous evaluation conducted at the first site. Of the 55 participants enrolled in the program over 6 years, 49 completed the basic program resulting in 22 academic publications, 21 conference presentations, and 5 PhD enrolments. Qualitative data suggest the first cohort of participants and mentors at both sites experienced similar benefits and challenges. The Stepping into Research program has led to tangible research outcomes, has been sustained over 6 years, and been translated to a second health service. Questions remain about the impact of the program on clinical outcomes and research culture.

  15. The frontline clinical manager identifying direct reports' level of practice.

    Science.gov (United States)

    Longo, M Anne; Roussel, Linda; Pennington, Sandra L; Hoying, Cheryl

    2013-01-01

    Patricia Benner applied the Dreyfus Model of Skill Acquisition to describe and interpret skill acquisition and clinical judgment in nursing practice. Operational definitions for the 5 levels of her original Novice to Expert Theory were used by the study participants in a large Midwestern pediatric hospital to self-identify their level of practice. The frontline clinical managers of these direct care registered nurses (RNs) used the same tool to rate their direct reports. The aim of this portion of a larger study was to determine if the clinical manager's perception of their direct reports was the same as that of the RNs. The results of this study are being used by one study unit's clinical managers as the basis for implementing the Hersey and Blanchard Situational Leadership Model. The clinical managers work with their direct reports depending on the level of practice and the details of the task to be performed. One example is creating therapeutic relationships with each other and with families to ensure a safe environment for all.

  16. Clinical Pharmacy Education and Training Program: A Special Report.

    Science.gov (United States)

    American Association of Colleges of Pharmacy, Bethesda, MD.

    The purpose of the report is to give a state-of-the-art picture of clinical pharmacy education and training in the United States as represented by 4 prototype pharmacy school curricula chosen for documentation by the American Association of Colleges of Pharmacy. Criteria for selection relate to the environment in which the various curricula are…

  17. Clinical Training in Aging and Mental Health. Final Report.

    Science.gov (United States)

    Gatz, Margaret; And Others

    This report describes the University of Southern California's (USC) gerontology career preparation project, which was funded for the following training activities in mental health and aging: (1) traineeships for graduate students in USC's doctoral track in clinical psychology and aging and in the Leonard Davis School of Gerontology master's track…

  18. Changes in clinical and hotel expenditures following publication of the nursing home compare report card.

    Science.gov (United States)

    Mukamel, Dana B; Spector, William D; Zinn, Jacqueline; Weimer, David L; Ahn, Richard

    2010-10-01

    Nursing Home Compare first published clinical quality measures at the end of 2002. It is a quality report card that for the first time offers consumers easily accessible information about the clinical quality of nursing homes. It led to changes in consumers' demand, increasing the relative importance of clinical versus hotel aspects of quality in their search and choice of a nursing home. To examine the hypothesis that nursing homes responding to these changes in demand shifted the balance of resources from hotel to clinical activities. The study included 10,022 free-standing nursing homes nationwide during 2001 to 2006. RESEARCH DESIGN AND DATA: A retrospective multivariate statistical analysis of trends in the ratio of clinical to hotel expenditures, using Medicare cost reports, Minimum Data Set and Online Survey, Certification and Reporting data, controlling for changes in residents' acuity and facility fixed effects. Inference is based on robust standard errors. The ratio of clinical to hotel expenditures averaged 1.78. It increased significantly (P hotel expenditures following publication of the report card suggests that nursing homes responded as expected to the changes in the elasticity of demand with respect to clinical quality brought about by the public reporting of clinical quality measures. The response was stronger among nursing homes facing stronger incentives.

  19. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    Directory of Open Access Journals (Sweden)

    S. Nicole Culos-Reed

    2012-01-01

    Full Text Available Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies.

  20. Safety and pharmacodynamic effects of a pharmacological chaperone on α-galactosidase A activity and globotriaosylceramide clearance in Fabry disease: report from two phase 2 clinical studies

    Directory of Open Access Journals (Sweden)

    Germain Dominique P

    2012-11-01

    Full Text Available Abstract Background Fabry disease (FD is a genetic disorder resulting from deficiency of the lysosomal enzyme α-galactosidase A (α-Gal A, which leads to globotriaosylceramide (GL-3 accumulation in multiple tissues. We report on the safety and pharmacodynamics of migalastat hydrochloride, an investigational pharmacological chaperone given orally at 150 mg every-other-day. Methods Two open-label uncontrolled phase 2 studies of 12 and 24 weeks (NCT00283959 and NCT00283933 in 9 males with FD were combined. At multiple time points, α-Gal A activity and GL-3 levels were quantified in blood cells, kidney and skin. GL-3 levels were also evaluated through skin and renal histology. Results Compared to baseline, increased α-Gal A activity of at least 50% was demonstrated in blood, skin and kidney in 6 of 9 patients. Patients’ increased α-Gal A activities paralleled the α-Gal A increases observed in vitro in HEK-293 cells transfected with the corresponding mutant form of the enzyme. The same 6 patients who demonstrated increases of α-Gal A activity also had GL-3 reduction in skin, urine and/or kidney, and had α-Gal A mutations that responded in transfected cells incubated with the drug. The 3 patients who did not show a consistent response in vivo had α-Gal A mutations that did not respond to migalastat HCl in transfected cells. Migalastat HCl was well tolerated. Conclusions Migalastat HCl is a candidate pharmacological chaperone that provides a novel genotype-specific treatment for FD. It enhanced α-Gal A activity and resulted in GL-3 substrate decrease in patients with responsive GLA mutations. Phase 3 studies are ongoing. Trial registration Clinicaltrial.gov: NCT00283959 and NCT00283933

  1. The automation of clinical trial serious adverse event reporting workflow

    Science.gov (United States)

    London, Jack W; Smalley, Karl J; Conner, Kyle; Smith, J Bruce

    2011-01-01

    Background The reporting of serious adverse events (SAEs) is a requirement when conducting a clinical trial involving human subjects, necessary for the protection of the participants. The reporting process is a multi-step procedure, involving a number of individuals from initiation to final review, and must be completed in a timely fashion. Purpose The purpose of this project was to automate the adverse event reporting process, replacing paper-based processes with computer-based processes, so that personnel effort and time required for serious adverse event reporting was reduced, and the monitoring of reporting performance and adverse event characteristics was facilitated. Methods Use case analysis was employed to understand the reporting workflow and generate software requirements. The automation of the workflow was then implemented, employing computer databases, web-based forms, electronic signatures, and email communication. Results In the initial year (2007) of full deployment, 588 SAE reports were processed by the automated system, eSAEy™. The median time from initiation to Principal Investigator electronic signature was less than 2 days (mean 7 ± 0.7 days). This was a significant reduction from the prior paper-based system, which had a median time for signature of 24 days (mean of 45 ± 5.7 days). With eSAEy™, reports on adverse event characteristics (type, grade, etc.) were easily obtained and had consistent values based on standard terminologies. Limitation The automated system described was designed specifically for the work flow at Thomas Jefferson University. While the methodology for system design, and the system requirements derived from common clinical trials adverse reporting procedures are applicable in general, specific work flow details may not relevant at other institutions. Conclusion The system facilitated analysis of individual investigator reporting performance, as well as the aggregation and analysis of the nature of reported adverse

  2. Effects of acupuncture, core-stability exercises, and treadmill walking exercises in treating a patient with postsurgical lumbar disc herniation: a clinical case report.

    Science.gov (United States)

    Ganiyu, Sokunbi Oluwaleke; Gujba, Kachalla Fatimah

    2015-02-01

    The objective of this study is to investigate the effects of acupuncture, core-stability exercises, and treadmill 12-minute walking exercises in treating patients with postsurgical lumbar disc herniation. A 34-year-old woman with a history lumbar disc prolapse who had undergone lumbar disc surgery on two different occasions was treated using acupuncture, core-stability exercises, and treadmill walking exercises three times per week for 12 weeks. The outcome measures used in this study were pain intensity, spinal range of movement, and general health. After 12 weeks of treatment, the patient had made improvement in terms of pain, which was reduced from 9/10 to 1/10. In a similar vein, the patient's general health showed improvement of >100% after 12 weeks of treatment. Pre-treatment scores of spinal flexion and left-side flexion, which measured 20 cm and 12 cm, respectively, increased to 25 cm and 16 cm after 12 weeks of treatment. This study showed that acupuncture, core-stability exercises, and treadmill walking exercises were useful in relieving pain, increasing spinal range of movement, and improving the health of a patient with postsurgical lumbar disc herniation. Copyright © 2015. Published by Elsevier B.V.

  3. Review of the Reported Measures of Clinical Validity and Clinical Utility as Arguments for the Implementation of Pharmacogenetic Testing: A Case Study of Statin-Induced Muscle Toxicity

    Directory of Open Access Journals (Sweden)

    Marleen E. Jansen

    2017-08-01

    Full Text Available Advances from pharmacogenetics (PGx have not been implemented into health care to the expected extent. One gap that will be addressed in this study is a lack of reporting on clinical validity and clinical utility of PGx-tests. A systematic review of current reporting in scientific literature was conducted on publications addressing PGx in the context of statins and muscle toxicity. Eighty-nine publications were included and information was selected on reported measures of effect, arguments, and accompanying conclusions. Most authors report associations to quantify the relationship between a genetic variation an outcome, such as adverse drug responses. Conclusions on the implementation of a PGx-test are generally based on these associations, without explicit mention of other measures relevant to evaluate the test's clinical validity and clinical utility. To gain insight in the clinical impact and select useful tests, additional outcomes are needed to estimate the clinical validity and utility, such as cost-effectiveness.

  4. Porcelain veneers as an alternative for esthetic treatment: clinical report.

    Science.gov (United States)

    Rotoli, B T; Lima, D A N L; Pini, N P; Aguiar, F H B; Pereira, G D S; Paulillo, L A M S

    2013-01-01

    This case report describes the restoration of the anterior dentition with porcelain laminate veneers. The advances in bonding of porcelain to tooth structure make this treatment a feasible alternative to restore teeth with alteration in shape and position in cases in which the esthetic demand is high. The rationale for various choices in this treatment protocol is detailed with reference to the pertinent literature. Thus, the clinical success of the technique depends on the correct identification of a case for which this treatment is appropriate and the successful execution of the clinical steps involved.

  5. Impact of document type on reporting quality of clinical drug trials: a comparison of registry reports, clinical study reports, and journal publications.

    Science.gov (United States)

    Wieseler, Beate; Kerekes, Michaela F; Vervoelgyi, Volker; McGauran, Natalie; Kaiser, Thomas

    2012-01-03

    To investigate to what extent three types of documents for reporting clinical trials provide sufficient information for trial evaluation. Retrospective analysis Primary studies and corresponding documents (registry reports, clinical study reports, journal publications) from 16 health technology assessments of drugs conducted by the German Institute for Quality and Efficiency in Health Care between 2006 and February 2011. Data analysis We assessed reporting quality for each study and each available document for six items on methods and six on outcomes, and dichotomised them as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of studies with complete reporting for methods and outcomes, per item and overall, and compared the findings. We identified 268 studies. Publications, study reports and registry reports were available for 192 (72%), 101 (38%), and 78 (29%) studies, respectively. Reporting quality was highest in study reports, which overall provided complete information for 90% of items (1086/1212). Registry reports provided more complete information on outcomes than on methods (overall 330/468 (71%) v 147/468 (31%)); the same applied to publications (594/1152 (52%) v 458/1152 (40%)). In the matched pairs analysis, reporting quality was poorer in registry reports than in study reports for overall methods and outcomes (P<0.001 in each case). Compared with publications, reporting quality was poorer in registry reports for overall methods (P<0.001), but better for outcomes (P=0.005). Registry reports and publications insufficiently report clinical trials but may supplement each other. Measures to improve reporting include the mandatory worldwide implementation of adequate standards for results registration.

  6. Computer utilization and clinical judgment in psychological assessment reports.

    Science.gov (United States)

    Lichtenberger, Elizabeth O

    2006-01-01

    The process of assessment report writing is a complex one, involving both the statistical evaluation of data and clinical methods of data interpretation to appropriately answer referral questions. Today, a computer often analyzes data generated in a psychological assessment, at least in part. In this article, the author focuses on the interaction between the decision-making processes of human clinicians and the test interpretations that are computer-based. The benefits and problems with computers in assessment are highlighted and are presented alongside the research on the validity of automated assessment, as well as research comparing clinicians and computers in the decision-making process. The author concludes that clinical judgment and computer-based test interpretation each have weaknesses. However, by using certain strategies to reduce clinicians' susceptibility to errors in decision making and to ensure that only valid computer-based test interpretations are used, clinicians can optimize the accuracy of conclusions that they draw in their assessment report.

  7. Using Local Grammar for Entity Extraction from Clinical Reports

    Directory of Open Access Journals (Sweden)

    Aicha Ghoulam

    2015-06-01

    Full Text Available Information Extraction (IE is a natural language processing (NLP task whose aim is to analyze texts written in natural language to extract structured and useful information such as named entities and semantic relations linking these entities. Information extraction is an important task for many applications such as bio-medical literature mining, customer care, community websites, and personal information management. The increasing information available in patient clinical reports is difficult to access. As it is often in an unstructured text form, doctors need tools to enable them access to this information and the ability to search it. Hence, a system for extracting this information in a structured form can benefits healthcare professionals. The work presented in this paper uses a local grammar approach to extract medical named entities from French patient clinical reports. Experimental results show that the proposed approach achieved an F-Measure of 90. 06%.

  8. Clinical Teaching Effectiveness Instrument: Development and Psychometric Testing.

    Science.gov (United States)

    Copeland, H. Liesel; Hewson, Mariana

    This report describes the development and psychometric qualities of a new instrument to assess clinical teaching effectiveness in medical education. The strength of the instrument is seen to lie in the qualitative development process involving iterative checking with key stakeholders; its high reliability, validity, and feasibility; and its ease…

  9. Sonosurgery for atraumatic tooth extraction: a clinical report.

    Science.gov (United States)

    Papadimitriou, Dimitrios E V; Geminiani, Alessandro; Zahavi, Thomas; Ercoli, Carlo

    2012-12-01

    The preservation of an intact labial plate during tooth extraction is a critical determinant of whether an immediate implant can be placed and is also an important predictor of the esthetic result. The purpose of this clinical report was to present a method for atraumatic tooth extraction by using an air-driven sonic instrument with specially designed inserts. This surgical technique provides the clinician with an efficient method for atraumatic tooth extraction and preservation of an intact labial plate.

  10. Apicetomy or dental implant: Report of a clinical case.

    OpenAIRE

    Enrique Fernández-Bodereau; Patricia Tortolini

    2012-01-01

    We report a clinical case of a patient who underwent apicectomy on an upper premolar, presumably by endodontic done improperly, and have cast a bolt where the extraction run the risk of tooth fracture. Failed such treatment, an implant is performed, placed immediately after extraction, in which bone filling with xenograft and guided bone regeneration with resorbable collagen membrane was done. From this we deduce that the phase diagnosed is of paramount importance. Two months after functional...

  11. Differential case reporting in a national clinical quality database

    DEFF Research Database (Denmark)

    Mårtensson, Solvej; Frederiksen, Birgitte Lidegaard; De Nully Brown, Peter

    2012-01-01

    Selection biases due to difference in reporting may cause spurious findings. The purpose of this study was to illustrate the effect of case incompleteness on the differences in 180-day survival rate when comparing departments.......Selection biases due to difference in reporting may cause spurious findings. The purpose of this study was to illustrate the effect of case incompleteness on the differences in 180-day survival rate when comparing departments....

  12. Regulating the placebo effect in clinical practice.

    Science.gov (United States)

    Chan, Tracey E

    2015-01-01

    Recent research and ethical analysis have forced a clinical and ethical reappraisal of the utility of placebos in medical practice. The main concern of ethics and law is that using placebos in health care involves deception, which is antithetical to patient autonomy and trust in the physician-patient relationship. This article reviews the various, more nuanced scientific conceptions of the placebo effect, and evaluates the ethical and legal objections to deploying placebos in clinical practice. It argues that the placebo effect may be legitimately accommodated on the basis that it does not engage the requirement for material or quasi-fiduciary disclosures of information, and may also be justified by therapeutic privilege. In addition, this reconceptualisation of the placebo effect offers a new justification for therapeutic privilege in these contexts. Notwithstanding this, using the placebo effect in clinical practice raises regulatory issues that will require special regulatory supervision.

  13. [Neurological effects of American trypanosomyiasis: clinical aspects].

    Science.gov (United States)

    León-Sarmiento, Fidias E; Prada, Diddier G; Bayona-Prieto, Jaime; Valderrama, Vladimir; García, Ingrid; León, Marta E; Sunnemark, Dan

    2003-12-01

    Trypanosoma cruzi, causative agent of Chagas disease, affects not only cardiac and intestinal structures but also neurological structures. A high prevalence of T. cruzi infection occurs in Colombia, prompting the present study. First, a qualitative metaanalysis was undertaken using the PubMed database, the electronic internet engine Altavista, Colombian journals indexed by Colciencias, and three relevant textbooks. The following key words were used: Trypanosoma, Chagas disease, nervous system, spinal cord, central nervous system, peripheral nervous system, neuromuscular junction, autonomic nervous system, muscle, muscle disorders, neuromuscular disease, neuromuscular disorders, synapticopathies and dysautonomia. The documents analyzed numbered 116 and included original papers, reviews, case reports, editorials, brief communications, conferences and book chapters. At minimum, each document included data involving ELISA testing, indirect immunofluorescense, or parasitemia levels in the clinical, serological or histopathological studies. Polymerase chain reaction (PCR) studies were not included because of the recent introduction of PCR as a confirmatory technique for Chagas disease in Colombia. Chagas disease affects the central, the peripheral and the autonomic nervous system in humans, although its effects on the antonomic system is most commonly investigated in Colombia. Neurological lesions must be evaluated carefully, because patients may be misdiagnosed and treated as carriers of 'idiopathic' diseases. Neurological pathologies poses a serious threat in Colombia due to the prevalence of Chagas disease.

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

    Directory of Open Access Journals (Sweden)

    Travison Thomas G

    2007-11-01

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

  15. Dual cusped protostylid: Case report and clinical significance

    Directory of Open Access Journals (Sweden)

    Preeti Bhattacharya

    2016-01-01

    Full Text Available Protostylids are superstructures on maxillary or mandibular molars, which have rarely been reported in literature, and the significance of their presence has also been underestimated. The dental practitioners may easily misdiagnose a tooth, with such conical tubercles as malformed tooth. Interestingly, this is neither a malformation nor an anomaly but rather an important morphological trait of an individual. Once in a while, one may come across such a distinct morphological trait without being able to diagnose. To the authors' best knowledge, only one similar case has been reported previously, and the second such case internationally. Bearing all such facts in mind, the authors attempt to educate the readers towards the existence of such a trait so that it can be identified and studied in larger numbers. Hence, it is the authors' endeavor to report an unusual case of dual cusped maxillary protostylid along with its clinical significance.

  16. A Clinical Report of Nonsyndromic Concomitant Hypo-Hyperdontia

    Directory of Open Access Journals (Sweden)

    Siddarth Gupta

    2013-01-01

    Full Text Available Although hypodontia and supernumerary teeth are often considered as mutually exclusive conditions, this case report presents an unusual case of hypodontia and a supernumerary tooth occurring simultaneously. An adolescent male was referred to the local hospital department regarding upper arch crowding. Plain film radiographs confirmed the congenital absence of both lower lateral incisors in addition to an unerupted conical supernumerary tooth in the maxillary midline. This condition has been called hypo-hyperdontia and in this paper, we discuss the clinical findings and treatment planning considerations in relation to the limited number of previously reported cases. The case report raises awareness of concomitant hypo-hyperdontia and serves to highlight that concomitant anomalies should be excluded when hypodontia or supernumerary teeth are diagnosed.

  17. Placebo effects: clinical aspects and neurobiology.

    Science.gov (United States)

    Oken, Barry S

    2008-11-01

    Placebo effects are beneficial health outcomes not related to the relatively direct biological effects of an intervention and can be elicited by an agent that, by itself, is inert. Understanding these placebo effects will help to improve clinical trial design, especially for interventions such as surgery, CNS-active drugs and behavioural interventions which are often non-blinded. A literature review was performed to retrieve articles discussing placebo implications of clinical trials, the neurobiology of placebo effects and the implications of placebo effect for several disorders of neurological relevance. Recent research in placebo analgesia and other conditions has demonstrated that several neurotransmitter systems, such as opiate and dopamine, are involved with the placebo effect. Brain regions including anterior cingulate cortex, dorsolateral prefrontal cortex and basal ganglia have been activated following administration of placebo. A patient's expectancy of improvement may influence outcomes as much as some active interventions and this effect may be greater for novel interventions and for procedures. Maximizing this expectancy effect is important for clinicians to optimize the health of their patient. There have been many relatively acute placebo studies that are now being extended into clinically relevant models of placebo effect.

  18. Reporting incidental findings in genomic scale clinical sequencing--a clinical laboratory perspective: a report of the Association for Molecular Pathology.

    Science.gov (United States)

    Hegde, Madhuri; Bale, Sherri; Bayrak-Toydemir, Pinar; Gibson, Jane; Jeng, Linda Jo Bone; Joseph, Loren; Laser, Jordan; Lubin, Ira M; Miller, Christine E; Ross, Lainie F; Rothberg, Paul G; Tanner, Alice K; Vitazka, Patrik; Mao, Rong

    2015-03-01

    Advances in sequencing technologies have facilitated concurrent testing for many disorders, and the results generated may provide information about a patient's health that is unrelated to the clinical indication, commonly referred to as incidental findings. This is a paradigm shift from traditional genetic testing in which testing and reporting are tailored to a patient's specific clinical condition. Clinical laboratories and physicians are wrestling with this increased complexity in genomic testing and reporting of the incidental findings to patients. An enormous amount of discussion has taken place since the release of a set of recommendations from the American College of Medical Genetics and Genomics. This discussion has largely focused on the content of the incidental findings, but the laboratory perspective and patient autonomy have been overlooked. This report by the Association of Molecular Pathology workgroup discusses the pros and cons of next-generation sequencing technology, potential benefits, and harms for reporting of incidental findings, including the effect on both the laboratory and the patient, and compares those with other areas of medicine. The importance of genetic counseling to preserve patient autonomy is also reviewed. The discussion and recommendations presented by the workgroup underline the need for continued research and discussion among all stakeholders to improve our understanding of the effect of different policies on patients, providers, and laboratories.

  19. Using phrases and document metadata to improve topic modeling of clinical reports.

    Science.gov (United States)

    Speier, William; Ong, Michael K; Arnold, Corey W

    2016-06-01

    Probabilistic topic models provide an unsupervised method for analyzing unstructured text, which have the potential to be integrated into clinical automatic summarization systems. Clinical documents are accompanied by metadata in a patient's medical history and frequently contains multiword concepts that can be valuable for accurately interpreting the included text. While existing methods have attempted to address these problems individually, we present a unified model for free-text clinical documents that integrates contextual patient- and document-level data, and discovers multi-word concepts. In the proposed model, phrases are represented by chained n-grams and a Dirichlet hyper-parameter is weighted by both document-level and patient-level context. This method and three other Latent Dirichlet allocation models were fit to a large collection of clinical reports. Examples of resulting topics demonstrate the results of the new model and the quality of the representations are evaluated using empirical log likelihood. The proposed model was able to create informative prior probabilities based on patient and document information, and captured phrases that represented various clinical concepts. The representation using the proposed model had a significantly higher empirical log likelihood than the compared methods. Integrating document metadata and capturing phrases in clinical text greatly improves the topic representation of clinical documents. The resulting clinically informative topics may effectively serve as the basis for an automatic summarization system for clinical reports. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Bilateral Chondroepitrochlearis Muscle: Case Report, Phylogenetic Analysis, and Clinical Significance

    Directory of Open Access Journals (Sweden)

    Sujeewa P. W. Palagama

    2016-01-01

    Full Text Available Anomalous muscular variants of pectoralis major have been reported on several occasions in the medical literature. Among them, chondroepitrochlearis is one of the rarest. Therefore, this study aims to provide a comprehensive description of its anatomy and subsequent clinical significance, along with its phylogenetic importance in pectoral muscle evolution with regard to primate posture. The authors suggest a more appropriate name to better reflect its proximal attachment to the costochondral junction and distal attachment to the epicondyle of humerus, as “chondroepicondylaris”; in addition, we suggest a new theory of phylogenetic significance to explain the twisting of pectoralis major tendon in primates that may have occurred with their adoption to bipedalism and arboreal lifestyle. Finally, the clinical significance of this aberrant muscle is elaborated as a cause of potential neurovascular entrapment and as a possible hurdle during axillary surgeries (i.e., mastectomy.

  1. Survey and Practice of Reporting Quality of Randomized Controlled Clinical Trials on Traditional Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    LI Ting-qian; MAO Bing; WANG Gang; CHANG Jing; WANG Lei

    2008-01-01

    @@ Evidence obtained from randomized controlled trials (RCTs) has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully understand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner.

  2. Providing effective supervision in clinical neuropsychology.

    Science.gov (United States)

    Stucky, Kirk J; Bush, Shane; Donders, Jacobus

    2010-01-01

    A specialty like clinical neuropsychology is shaped by its selection of trainees, educational standards, expected competencies, and the structure of its training programs. The development of individual competency in this specialty is dependent to a considerable degree on the provision of competent supervision to its trainees. In clinical neuropsychology, as in other areas of professional health-service psychology, supervision is the most frequently used method for teaching a variety of skills, including assessment, report writing, differential diagnosis, and treatment. Although much has been written about the provision of quality supervision in clinical and counseling psychology, very little published guidance is available regarding the teaching and provision of supervision in clinical neuropsychology. The primary focus of this article is to provide a framework and guidance for the development of suggested competency standards for training of neuropsychological supervisors, particularly at the residency level. In this paper we outline important components of supervision for neuropsychology trainees and suggest ways in which clinicians can prepare for supervisory roles. Similar to Falender and Shafranske (2004), we propose a competency-based approach to supervision that advocates for a science-informed, formalized, and objective process that clearly delineates the competencies required for good supervisory practice. As much as possible, supervisory competencies are related to foundational and functional competencies in professional psychology, as well as recent legislative initiatives mandating training in supervision. It is our hope that this article will foster further discussion regarding this complex topic, and eventually enhance training in clinical neuropsychology.

  3. Clinical manifestations of Kingella kingae infections: case report and review.

    Science.gov (United States)

    Morrison, V A; Wagner, K F

    1989-01-01

    A patient with antecedent coccidioidal pulmonary cavitary disease who developed an empyema due to Kingella kingae prompted our analysis of the literature regarding this unusual bacterial pathogen. Formerly classified among other genera and considered a nonpathogen, K. kingae has been increasingly recognized as a cause of human infection. While the most commonly diagnosed infections due to this organism are endocarditis and septic arthritis, there have also been isolated reports of bacteremia, diskitis, abscesses, meningitis, and oropharyngeal infections. The treatment of choice is penicillin, to which K. kingae strains are uniformly susceptible. Recognition of the potential pathogenicity of this microorganism in appropriate clinical settings will probably result in more prompt and specific therapy.

  4. Case reports and clinical guidelines for managing radix entomolaris

    Science.gov (United States)

    Thomas, Bejoy J.; Nishad, A.; Paulaian, Benin; Sam, Jonathan Emil

    2016-01-01

    Knowledge about the external and internal anatomy of the tooth is essential for successful dental practice. Anomalies in the tooth are often encountered which poses difficulties in dental treatments. As like any other tooth, mandibular first molars are also prone for anatomic malformations. One such anatomic variation is the presence of extra root distolingually. This distolingual root is called radix entomolaris (RE). The presence of an additional root can lead to difficulties during endodontic therapy. This article is a report of two cases describing the management of the first mandibular molars with an RE and clinical guidelines for its management. PMID:27829770

  5. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    Science.gov (United States)

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome.

  6. Six-year susceptibility trends and effect of revised Clinical Laboratory Standards Institute breakpoints on ciprofloxacin susceptibility reporting in typhoidal Salmonellae in a tertiary care paediatric hospital in Northern India

    Directory of Open Access Journals (Sweden)

    R Saksena

    2016-01-01

    Full Text Available The antimicrobial trends over 6 years were studied, and the effect of revised Clinical Laboratory Standards Institute (CLSI breakpoints (2012 for ciprofloxacin susceptibility reporting in typhoidal Salmonellae was determined. A total of 874 (95.4% isolates were nalidixic acid-resistant (NAR. Using the CLSI 2011 guidelines (M100-S21, 585 (66.9% isolates were ciprofloxacin susceptible. The susceptibility reduced to 11 (1.25% isolates when interpreted using 2012 guidelines (M100-S22. Among the forty nalidixic acid susceptible (NAS Salmonellae, susceptibility to ciprofloxacin decreased from 37 isolates (M100-S21 to 12 isolates (M100-S22. The 25 cases which appeared resistant with newer guidelines had a minimum inhibitory concentration (MIC range between 0.125 and 0.5 μg/ml. MIC50 for the third generation cephalosporins varied between 0.125 and 0.5 μg/ml over 6 years whereas MIC90 varied with a broader range of 0.19–1 μg/ml. The gap between NAR and ciprofloxacin-resistant strains identified using 2011 guidelines has been reduced; however, it remains to be seen whether additional NAS, ciprofloxacin-resistant isolates are truly resistant to ciprofloxacin by other mechanisms of resistance.

  7. Six-year susceptibility trends and effect of revised Clinical Laboratory Standards Institute breakpoints on ciprofloxacin susceptibility reporting in typhoidal Salmonellae in a tertiary care paediatric hospital in Northern India.

    Science.gov (United States)

    Saksena, R; Nayyar, C; Manchanda, V

    2016-01-01

    The antimicrobial trends over 6 years were studied, and the effect of revised Clinical Laboratory Standards Institute (CLSI) breakpoints (2012) for ciprofloxacin susceptibility reporting in typhoidal Salmonellae was determined. A total of 874 (95.4%) isolates were nalidixic acid-resistant (NAR). Using the CLSI 2011 guidelines (M100-S21), 585 (66.9%) isolates were ciprofloxacin susceptible. The susceptibility reduced to 11 (1.25%) isolates when interpreted using 2012 guidelines (M100-S22). Among the forty nalidixic acid susceptible (NAS) Salmonellae, susceptibility to ciprofloxacin decreased from 37 isolates (M100-S21) to 12 isolates (M100-S22). The 25 cases which appeared resistant with newer guidelines had a minimum inhibitory concentration (MIC) range between 0.125 and 0.5 μg/ml. MIC50 for the third generation cephalosporins varied between 0.125 and 0.5 μg/ml over 6 years whereas MIC90 varied with a broader range of 0.19-1 μg/ml. The gap between NAR and ciprofloxacin-resistant strains identified using 2011 guidelines has been reduced; however, it remains to be seen whether additional NAS, ciprofloxacin-resistant isolates are truly resistant to ciprofloxacin by other mechanisms of resistance.

  8. Clinical report of 28 patients with Sheehan's syndrome.

    Science.gov (United States)

    Sert, Murat; Tetiker, Tamer; Kirim, Sinan; Kocak, Mustafa

    2003-06-01

    The aim of the present study was to determine the clinical and hormonal characteristics with Sheehan's syndrome in 28 cases that we had diagnosed and followed in the last 20 years. Twenty-eight patients with Sheehan's syndrome, diagnosed and followed at our University Endocrinology Clinic in the last 20 years were reported in the study. Medical history, physical examination, routine laboratory examinations, pituitary hormone analysis, CT and/or MRI scan of the sella of the patients were reviewed. All patients had a history of massive hemorrhage at delivery and physical signs of Sheehan's syndrome. Twenty-six of them lacked postpartum milk production, followed by failure of resumption of menses. There were 9 subjects with disturbances in consciousness associated with hyponatremia on admittance. All 28 patients had secondary hypothyroidism, adrenal cortex failure, hypogonadotrophic hypogonadism and growth hormone deficiency. Diabetes insipidus has not been found in any patient. Empty sellae were revealed in 8 patients by CT and/or MRI scan. Sheehan's syndrome is still encountered in clinical practice occasionally. If not diagnosed early, it could cause increased morbidity and mortality. The most important clues for diagnosis of Sheehan's syndrome are lack of lactation and failure of menstrual resumption after a delivery complicated with severe hemorrhage.

  9. [Clinical significance of the placebo effect].

    Science.gov (United States)

    Oeltjenbruns, J; Schäfer, M

    2008-05-01

    Placebo controlled studies examining clinical problems, e.g. in pain therapy, are considered the "gold standard" for evidence-based medicine. In these studies the placebo effect itself is not the main focus of interest, but serves more as a control for the specificity of the effect of a certain treatment. What physicians in this context often do not realize is that the placebo effect itself represents a true measurable correlate of an organism's psycho-neurobiological response and, thereby, influences the healing process, e.g. the pain relief. Placebo is, therefore, not equivalent to "no treatment". The number of placebo responders, the degree and the duration of the placebo effect is not fixed, but are subject to a much greater variability then hitherto believed. The myth that placebo responders have a certain personality has not been proven correct; instead, the relationships between physicians and patients as well as sociocultural factors have a considerable impact on the placebo effect. Psychological theories explain that classical conditioning, enhanced expectation and motivation of the patient determine the degree of the placebo effect. These directly influence neurobiological systems such as the endogenous opioids which according to modern brain imaging are predominantly activated in pain-relevant areas and contribute to the effect of placebo analgesia. Placebo effects that should be deliberately excluded in controlled clinical trials, can be desirable in clinical practice to optimize the total therapeutic effect. This should mean that the context effect of each therapeutic intervention is maximized towards an improved therapeutic effect, as outlined in the recent AWMF guidelines for postoperative pain therapy, but should not include the administration of an inert substance. The latter is controlled by rigorous ethical guidelines and is only permitted in the context of ethically approved controlled clinical trials. A possible alternative is suggested by

  10. Unilateral Vogt-Koyanagi-Harada Disease: A Clinical Case Report

    Directory of Open Access Journals (Sweden)

    Arminda Neves

    2015-10-01

    Full Text Available Purpose: To report a case of a 20-year-old female with decreased visual acuity (VA in the left eye (LE. Methods: This is a retrospective and descriptive case report based on data from clinical records, patient observation and analysis of diagnostic tests. Results: A 20-year-old female presented with decreased VA in the LE for 3 days. Best-corrected visual acuity (BCVA was 20/20 in the right eye (RE and 20/40 in the LE. Pupillary function, intraocular pressure, results of external segment examinations and slit-lamp biomicroscopy were normal, bilaterally. RE fundoscopy was normal, and in the LE it revealed papillitis and posterior pole exudative retinal detachment. Optical coherence tomography (OCT confirmed the macular serous retinal detachment and showed thickening of the posterior choroid also revealed by orbital ultrasound and magnetic resonance imaging (MRI. Fluorescein angiography showed angiographic features typical of Vogt-Koyanagi-Harada (VKH disease: disseminated spotted choroidal hyperfluorescence and choroidal multifocal hypofluorescence, multifocal profuse leakage in the retina with pooling, serous retinal detachment and optic disc hyperfluorescence. Serological testing for the diagnosis of infectious pathologies was negative, and the review of systems was normal. The patient received systemic steroids and cyclosporine. LE BCVA improved up to 20/20 at 18 months after the diagnosis, with complete reabsorption of subretinal fluid and normal retinal and choroidal thickness by OCT. Conclusion: Despite the unilateral involvement, the clinical and angiographic features were typical of VKH disease, and ophthalmologists should be aware to recognize this rare clinical variant of the disease.

  11. Reporting on methods of subgroup analysis in clinical trials: a survey of four scientific journals

    Directory of Open Access Journals (Sweden)

    E.D. Moreira Jr.

    2001-11-01

    Full Text Available Results of subgroup analysis (SA reported in randomized clinical trials (RCT cannot be adequately interpreted without information about the methods used in the study design and the data analysis. Our aim was to show how often inaccurate or incomplete reports occur. First, we selected eight methodological aspects of SA on the basis of their importance to a reader in determining the confidence that should be placed in the author's conclusions regarding such analysis. Then, we reviewed the current practice of reporting these methodological aspects of SA in clinical trials in four leading journals, i.e., the New England Journal of Medicine, the Journal of the American Medical Association, the Lancet, and the American Journal of Public Health. Eight consecutive reports from each journal published after July 1, 1998 were included. Of the 32 trials surveyed, 17 (53% had at least one SA. Overall, the proportion of RCT reporting a particular methodological aspect ranged from 23 to 94%. Information on whether the SA preceded/followed the analysis was reported in only 7 (41% of the studies. Of the total possible number of items to be reported, NEJM, JAMA, Lancet and AJPH clearly mentioned 59, 67, 58 and 72%, respectively. We conclude that current reporting of SA in RCT is incomplete and inaccurate. The results of such SA may have harmful effects on treatment recommendations if accepted without judicious scrutiny. We recommend that editors improve the reporting of SA in RCT by giving authors a list of the important items to be reported.

  12. Why prudence is needed when interpreting articles reporting clinical trial results in mental health.

    Science.gov (United States)

    Dal-Ré, Rafael; Bobes, Julio; Cuijpers, Pim

    2017-03-28

    Clinical trial results' reliability is impacted by reporting bias. This is primarily manifested as publication bias and outcome reporting bias. Mental health trials are prone to two methodological deficiencies: (1) using small numbers of participants that facilitates false positive findings and exaggerated size effects, and (2) the obligatory use of psychometric scales that require subjective assessments. These two deficiencies contribute to the publication of unreliable results. Considerable reporting bias has been found in safety and efficacy findings in psychotherapy and pharmacotherapy trials. Reporting bias can be carried forward to meta-analyses, a key source for clinical practice guidelines. The final result is the frequent overestimation of treatment effects that could impact patients and clinician-informed decisions. Prospective registration of trials and publication of results are the two major methods to reduce reporting bias. Prospective trial registration will allow checking whether they are published (so it will help to prevent publication bias) and, if published, whether those outcomes and analyses that were deemed as appropriate before trial commencement are actually published (hence helping to find out selective reporting of outcomes). Unfortunately, the rate of registered trials in mental health interventions is low and, frequently, of poor quality. Clinicians should be prudent when interpreting the results of published trials and some meta-analyses - such as those conducted by scientists working for the sponsor company or those that only include published trials. Prescribers, however, should be confident when prescribing drugs following the summary of product characteristics, since regulatory agencies have access to all clinical trial results.

  13. Clinical Effects of Prebiotics in Pediatric Population.

    Science.gov (United States)

    Orel, Rok; Reberšak, Lea Vodušek

    2016-12-15

    Prebiotics are non-digestible components of food that in a selective manner trigger the expansion of microbes in the gut with valuable effects for the health of the host. In our document, current literature pertaining to the clinical effects of the use of prebiotics for the treatment and prevention of some common pediatric pathology such as infantile colic, constipation, absorption of minerals, weight gain, diarrhea, respiratory infections, and eczema is reviewed. Data was collected through search of the MEDLINE, PubMed, UpToDate, Cochrane Database of Systemic Reviews, and the Cochrane Controlled Trials Register database as well as through references from relevant articles, all until September 2015. However, only the results of publications with adequate methodological quality were included. Prebiotics seem to be very appealing in treatment of many clinical conditions, explicitly in the fight against constipation, poor weight gain in preterm infants, and eczema in atopic children. In contrast to probiotics, the evidence of true clinical efficacy of prebiotics, supported with exact type and dose information are rather sparse, and there are a limited number of randomized controlled trials concerning prebiotics in children, especially beyond the age of infancy. Large well-designed, controlled, confirmatory clinical trials are required, using commercially available products, to help healthcare providers in making an appropriate decision concerning the appropriate use of prebiotics in different conditions.

  14. CLINICAL EFFECTS OF ROPIVACAINE MESYLATE IN EPIDURAL ANESTHESIA AND ANALGESIA

    Institute of Scientific and Technical Information of China (English)

    Jian-qing Xu; Bo Zhu; Tie-hu Ye

    2005-01-01

    @@ SINCE the report that ropivacaine hydrochloride, a new amide local anesthetic, is of lower cardiac toxicity both in animals and humans,1 several studies have shown it to be a clinically effective local anesthetic widely used for both epidural anesthesia2-4 and analgesia5-7. Ropivacaine mesylate made in China is structurally from ropivacaine hydrochloride by substituting a mesylate group for hydrochloride group.8 This study was designed to clinically provide a double-blind comparison of ropivacaine mesylate with ropivacaine hydrochloride in epidural anesthesia and analgesia.

  15. A knowledge-based, automated method for phenotyping in the EHR using only clinical pathology reports.

    Science.gov (United States)

    Yahi, Alexandre; Tatonetti, Nicholas P

    2015-01-01

    The secondary use of electronic health records (EHR) represents unprecedented opportunities for biomedical discovery. Central to this goal is, EHR-phenotyping, also known as cohort identification, which remains a significant challenge. Complex phenotypes often require multivariate and multi-scale analyses, ultimately leading to manually created phenotype definitions. We present Ontology-driven Reports-based Phenotyping from Unique Signatures (ORPheUS), an automated approach to EHR-phenotyping. To do this we identify unique signatures of abnormal clinical pathology reports that correspond to pre-defined medical terms from biomedical ontologies. By using only the clinical pathology, or "lab", reports we are able to mitigate clinical biases enabling researchers to explore other dimensions of the EHR. We used ORPheUS to generate signatures for 858 diseases and validated against reference cohorts for Type 2 Diabetes Mellitus (T2DM) and Atrial Fibrillation (AF). Our results suggest that our approach, using solely clinical pathology reports, is an effective as a primary screening tool for automated clinical phenotyping.

  16. Evaluating the Reliability of EHR-Generated Clinical Outcomes Reports: A Case Study.

    Science.gov (United States)

    Kanger, Chatrian; Brown, Lisanne; Mukherjee, Snigdha; Xin, Haichang; Diana, Mark L; Khurshid, Anjum

    2014-01-01

    Quality incentive programs, such as Meaningful Use, operate under the assumption that clinical quality measures can be reliably extracted from EHRs. Safety Net providers, particularly Federally Qualified Health Centers and Look-Alikes, tend to be high adopters of EHRs; however, recent reports have shown that only about 9% of FQHCs and Look-Alikes were demonstrating meaningful use as of 2013. Our experience working with the Crescent City Beacon Community (CCBC) found that many health centers relied on chart audits to report quality measures as opposed to electronically generating reports directly from their EHRs due to distrust in the data. This paper describes a step-by-step process for improving the reliability of data extracted from EHRs to increase reliability of quality measure reports, to support quality improvement, and to achieve alignment with national clinical quality reporting requirements. Lack of standardization in data capture and reporting within EHRs drives distrust in EHR-reported data. Practices or communities attempting to achieve standardization may look to CCBC's experience for guidance on where to start and the level of resources required in order to execute a data standardization project. During the time of this data standardization project, CCBC was launching an HIE. Lack of trust in EHR data was a driver for distrust in the HIE data. We present a case study where a five-step process was used to harmonize measures, reduce data errors, and increase trust in EHR clinical outcomes reports among a community of Safety Net providers using a common EHR. Primary outcomes were the incidence of reporting errors and the potential effect of error types on quality measure percentages. The activities and level of resources required to achieve these results were also documented by the CCBC program. Implementation of a community-wide data reporting project resulted in measure harmonization, reduced reporting burden, and error reduction in EHR

  17. Effects of healing touch in clinical practice: a systematic review of randomized clinical trials.

    Science.gov (United States)

    Anderson, Joel G; Taylor, Ann Gill

    2011-09-01

    Hands-on healing and energy-based interventions have been found in cultures throughout history around the world. These complementary therapies, rooted in ancient Eastern healing practices, are becoming mainstream. Healing Touch, a biofield therapy that arose in the nursing field in the late 1980s, is used in a variety of settings (i.e., pain centers, surgical settings, and private practices) with reported benefits (i.e., decreased anxiety, pain, and depressive behaviors; increased relaxation and a sense of well-being). However, clinical trial data concerning the effectiveness of Healing Touch have not been evaluated using a systematic, evidence-based approach. Thus, this systematic review is aimed at critically evaluating the data from randomized clinical trials examining the clinical efficacy of Healing Touch as a supportive care modality for any medical condition.

  18. Treatnebt if Addiction - Clinical and Judicial Perspectives: Two Case Reports

    Directory of Open Access Journals (Sweden)

    Sofia Fonseca

    2013-12-01

    Full Text Available The sporadic or chronic use of drugs and alcohol is directly related to conduct disorders and to the triggering of psychopathological states of sub-acute or chronic course. The excessive consumption of alcohol and excessive traffic/consumption of illicit drugs by individuals without mental illness or disability are actions of free will; they are therefore criminally responsible for their behaviour, even if they commit a crime during the state of intoxication, which the individual chose voluntarily to experience. In clinical practice, it is widely accepted that the treatment of these disorders is only effective when the patient accepts it voluntarily and that involuntary commitment (compulsive treatment is only carried out when the psychopathological state associated justifies the presuppositions of Article 12 of the Mental Health Law. However, if the compulsive treatment is of a penal character, mandated by a judge, the individual is obligated to accept treatment, independent of whether or not he suffers from mental illness. The authors present two case studies, one of drug addiction, the other of alcoholism, and discuss the clinical and judicial perspectives on the treatment of these clinical entities.

  19. Report: Sensitivity pattern of ceftriaxone against different clinical isolates.

    Science.gov (United States)

    Bushra, Rabia; Sial, Ali Akbar; Rizvi, Mehwish; Shafiq, Yousra; Aslam, Nousheen; Bano, Nusrat

    2016-01-01

    Emerging resistance against broad-spectrum antibiotics for standard empiric therapy is a global concern. Ceftriaxone (broad spectrum, third generation cephalosporin) is widely used in tertiary care settings to treat severe bacterial infections usually non-responsive to other antibiotics. The aim of the study is to evaluate the current sensitivity pattern of ceftriaxone (30μg/disk) among different clinical isolates. For this purpose, three hundred clinical isolates including Escherichia coli (25%), Staphylococcus aureus (30%), Salmonella typhi (17%) and Klebsiella pneumoniae(20%) were collected from different pathological laboratories of Karachi, Pakistan. The in-vitro sensitivity of different Gram positive and Gram-negative bacteria was determined by disk-diffusion technique using 0.5 McFarland standard. Results showed that ceftriaxone was highly sensitive against Escherichia coli (90%) and least sensitive against Klebsiella pneumoniae (65%). It is concluded that the sensitivity of ceftriaxone is progressively decreasing in comparison with past studies creating an alarming situation. Therefore, continuous surveillance is required to determine the current resistance status of clinical pathogens and for effective anti-microbial therapy.

  20. 78 FR 7437 - Proposed Collection; Comment Request (60-Day FRN); The Clinical Trials Reporting Program (CTRP...

    Science.gov (United States)

    2013-02-01

    ... Clinical Trials Reporting Program (CTRP) Database (NCI) SUMMARY: In compliance with the requirement of... other technological collection techniques or other forms of information technology. To submit comments... publication. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600,...

  1. 45 CFR 60.11 - Reporting adverse actions on clinical privileges.

    Science.gov (United States)

    2010-10-01

    ...) of this section, the Secretary will designate another qualified entity for the reporting of this... 45 Public Welfare 1 2010-10-01 2010-10-01 false Reporting adverse actions on clinical privileges... Reporting of Information § 60.11 Reporting adverse actions on clinical privileges. (a) Reporting to...

  2. Apicetomy or dental implant: Report of a clinical case.

    Directory of Open Access Journals (Sweden)

    Enrique Fernández-Bodereau

    2012-07-01

    Full Text Available We report a clinical case of a patient who underwent apicectomy on an upper premolar, presumably by endodontic done improperly, and have cast a bolt where the extraction run the risk of tooth fracture. Failed such treatment, an implant is performed, placed immediately after extraction, in which bone filling with xenograft and guided bone regeneration with resorbable collagen membrane was done. From this we deduce that the phase diagnosed is of paramount importance. Two months after functional load of the implant is made with a cemented ceramic crown. One of the factors that influenced the positive outcome of this case, where immediately implants are placed to the tooth extraction is ultra microtextured surface of the used implant, besides being the bone table of these dental elements of thicker vestibular.

  3. FAMILIAL AMYLOID POLYNEUROPATHY——CLINICAL REPORT OF A FAMILY

    Institute of Scientific and Technical Information of China (English)

    李延峰; 郭玉璞; 池田修一; 方定华

    1996-01-01

    This paper reports a familial amyloid polyneumpathy (FAP) family in China. This family being investigated had 69 members of five generations. From the third generation, there have been 16 patients. The age of onset was about 3 to 5 decades. The initial symptoms were autonomic nerve symptcans, such as impotence, dyspepaia and diarrhoea, associated with the sensory loss of lower extremities. As the disease progressed. the upper extremities and motor ability were also involved. The duration of disease course wasabout 8-10 years, most patients died of infection and cacbexia. Sural biopsy in 3 patients had showed positive Congo red staining. From the clinical view, this FAP family is similar to FAP I found in Japan. Thetrue classification, however, should be confirmed by further genetic analysis.

  4. Odontogenic calcificant cystic tumor: a report of two clinical cases.

    Science.gov (United States)

    Reyes, Daniel; Villanueva, Julio; Espinosa, Sebastián; Cornejo, Marco

    2007-03-01

    Odontogenic Calcificant Cystic Tumor (OCCT) is an infrequent injury. It arises from odontogenic epithelial rests present in the maxilla, jaw or gum. Gorlin and col. described the OCCT for first time as an own pathological entity in 1962. Clinically, the OCCT represents 1% of the odontogenic injuries. It is possible to be found from the first decade to the eighth decade. It affects in same proportion the maxilla and the jaw, being the most common in the dented zones, with greater incidence in the first molar area. Two case reports of OCCT in two different ages, both in female individuals, one at 5 years old and the other at 35 years old are presented. Enucleation of the tumor was the treatment chosen. The purpose of this article is to present a review of the literature related to these two cases of OCCT and its treatment, putting an emphasis on its aetiology, biological behaviour and treatment.

  5. Histopathological and clinical traps in lichen sclerosus: a case report.

    Science.gov (United States)

    Brănişteanu, Daciana Elena; Brănişteanu, Daniel Constantin; Stoleriu, Gabriela; Ferariu, Dan; Voicu, Cătălina Maria; Stoica, Loredana Elena; Căruntu, Constantin; Boda, Daniel; Filip-Ciubotaru, Florina Mihaela; Dimitriu, Andreea; Radu, Cezar Doru

    2016-01-01

    Lichen sclerosus et atrophicus and limited systemic scleroderma (acrosclerosis) are inflammatory skin diseases that ultimately evolve into two distinct modes of atrophic scar formation, but which can easily be confused clinically. They are very rarely associated. The literature has reported cases in which lichen sclerosus was associated with various forms of scleroderma, but often with localized morphea. The characteristic histopathological picture of lichen sclerosus includes a thin epidermis, with orthohyperkeratosis and vascular degeneration in the basal layer, loss of elastic fibers, and band-like inflammatory infiltrate in the papillary dermis, while systemic sclerosis is characterized by excessive deposition of collagen in the dermis, accompanied by reduction in adnexal structures and their entrapment in collagen, and the presence of perivascular lymphocytic inflammatory infiltrate. We present the case of a 40-year-old female patient clinically diagnosed with systemic scleroderma and lichen sclerosus involving the genital mucosa. Physical examination in conjunction with laboratory findings (elevated antinuclear, anti-Scl-70, anti-SSA antibodies and immunogram) induced the supposition of the coexistence of lichen sclerosus and systemic scleroderma, fact confirmed by pathological examination. Systemic therapy with corticosteroids, immunosuppressive and phlebotropic drugs, peripheral vasodilators and other tropic adjuvants and topically potent topical corticosteroids was initiated. The course was favorable under therapy, the hardened skin slightly regaining elasticity, relief of itching and disappearance of lichen sclerosus lesions. Our case reaffirms the uncommon association of these two disorders. The importance of history, physical and laboratory examinations in making a diagnosis of certainty in emphasized.

  6. Clinical human brucellosis in Malaysia: a case report

    Directory of Open Access Journals (Sweden)

    Tyagita Hartady

    2014-04-01

    Full Text Available Clinical human brucellosis is quite rare in Malaysia although seroconverters are relatively more. This report describes a case of clinical human brucellosis in Malaysia. This case involved a 29-year-old research assistant in a veterinary microbiology laboratory. She complained of intermittent fever, anorexia, profuse sweating, malaise, headache, normotensive (110/60 mm Hg, muscle pain, and arthralgia for 3 d. Blood tests against dengue and malaria were negative thus she was prescribed vitamin C, paracetamol and cough syrup for common flu. The complaints, however, persisted on and off for the next 1 month. She eventually developed anemia and hypotension (90/50 mm Hg and started to show reduced body weight. Abdominal palpations revealed hepatomegaly and splenomegaly with pain. Thus, brucellosis was suspected before the Rose-Bengal plate test was performed, which revealed the presence of high level of antibody against Brucella. The same test was repeated after 14 d and the results confirmed the presence of high antibody level against Brucella. Following serum agglutination test, a diagnosis of brucellosis was made and she was eventually prescribed rifampicine p.o. once a day combined with doxycycline p.o. twice a day for 6 consecutive weeks before she made a full recovery.

  7. What makes an effective clinical trainer?

    Directory of Open Access Journals (Sweden)

    Mohammed Alsultan

    2011-01-01

    Full Text Available This study aims at identifying characteristics and behavioral patterns associated with the ideal tutor in different medical fields. This study is expected to answer two questions, first is effective supervision and how can this be determined? And secondly, what skills and qualities do effective supervisors need? An English limited search was performed in many databases including MEDLINE, BEI, and International ERIC for the last 20 years using many search items to identify characteristics cited in the literature as being important for effective clinical teaching. One hundred thirty two articles identified the review excluded literature relating to research supervision. Findings revealed that some of these investigations relied on the tutor′s point of view, others on a resident′s or a student′s opinion or both. Descriptors for effective clinical teachers were categorized into three main classes: (a teaching skills (i.e. well-prepared, practices evidence-based medicine and believes in its principles and applications, effective, accessible, and provides and accepts both positive and negative feedback, (b personality (i.e. enthusiastic, respectable, sincere, confident, humanitarian, and compassionate, and (c attitude (i.e. health advocate, good role-model, encouraging, non-judgmental, aware of learners′ growth, well-groomed, and appropriately dressed. Other factors such as the trainer′s health (i.e. professional, personal, and spiritual fulfillment and his/her scholarly activities were also identified.

  8. 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.

  9. Reporting of research quality characteristics of studies published in 6 major clinical dental specialty journals.

    Science.gov (United States)

    Pandis, Nikolaos; Polychronopoulou, Argy; Madianos, Phoebus; Makou, Margarita; Eliades, Theodore

    2011-06-01

    The objective of this article was to record reporting characteristics related to study quality of research published in major specialty dental journals with the highest impact factor (Journal of Endodontics, Journal of Oral and Maxillofacial Surgery, American Journal of Orthodontics and Dentofacial Orthopedics; Pediatric Dentistry, Journal of Clinical Periodontology, and International Journal of Prosthetic Dentistry). The included articles were classified into the following 3 broad subject categories: (1) cross-sectional (snap-shot), (2) observational, and (3) interventional. Multinomial logistic regression was conducted for effect estimation using the journal as the response and randomization, sample calculation, confounding discussed, multivariate analysis, effect measurement, and confidence intervals as the explanatory variables. The results showed that cross-sectional studies were the dominant design (55%), whereas observational investigations accounted for 13%, and interventions/clinical trials for 32%. Reporting on quality characteristics was low for all variables: random allocation (15%), sample size calculation (7%), confounding issues/possible confounders (38%), effect measurements (16%), and multivariate analysis (21%). Eighty-four percent of the published articles reported a statistically significant main finding and only 13% presented confidence intervals. The Journal of Clinical Periodontology showed the highest probability of including quality characteristics in reporting results among all dental journals. Copyright © 2011 Elsevier Inc. All rights reserved.

  10. Ongoing clinical trials of the pleiotropic effects of statins

    Directory of Open Access Journals (Sweden)

    Jean Davignon

    2005-04-01

    Full Text Available Jean Davignon1, Lawrence A Leiter21Clinical Research Institute of Montreal, Montreal, QC, Canada; 2Division of Endocrinology and Metabolism, St Michael’s Hospital, Toronto, ON, CanadaBackground: The multiple effects (ie, pleiotropic effects of statins have received increasing recognition and may have clinical applicability across a broad range of cardiovascular and noncardiovascular conditions. Objective: To determine the relevance and significance of ongoing clinical trials of the pleiotropic effects of statins, focusing on nonlipid effects. Method: Ongoing trials were identified through personal communication, reports presented at scientific meetings (2000–2004, and queries made to AstraZeneca, Bristol-Myers Squibb Co, Merck & Co, Novartis, and Pfizer, manufacturers of the currently marketed statins. Published trials and other source material were identified through electronic searches on MEDLINE (1990–2003, abstract books, and references identified from bibliographies of pertinent articles. Eligible studies were the clinical trials of statins currently under way in which primary or secondary outcomes included the statins’ nonlipid (ie, pleiotropic effect(s. Data were extracted and trial quality was assessed by the authors. Results: Of the 22 ongoing trials of the nonlipid effects of statins identified, 10 assessed inflammatory markers and plaque stabilization, 4 assessed oxidized low density lipoprotein/vascular oxidant stress, 3 assessed end-stage renal disease, 3 assessed fibrinogen/viscosity, 2 assessed endothelial function, 2 assessed acute coronary syndrome, 2 assessed aortic stenosis progression, and 1 each assessed hypertension, osteoporosis, ischemic burden, Alzheimer’s disease, multiple sclerosis, and stroke (outcomes often overlapped. Conclusion: Given the excellent safety and tolerability of statins as a class, full exploration of their pleiotropic effects has the potential to provide additional benefits to many patients

  11. Clinical evaluation of misonidazole for radiosensitizing effects

    Energy Technology Data Exchange (ETDEWEB)

    Mitsuhashi, Norio; Yonome, Ichiro; Niibe, Hideo (Gunma Univ., Maebashi (Japan). School of Medicine)

    1984-07-01

    Gunma Misonidazole Study Group has conducted an open clinical study to evaluate the radiosensitizing effects of misonidazole. Among the patients entered in this study, there were 119 patients with various local advanced or local recurrent radioresistant tumors. Of these, 29 patients had pulmonary cancer, 19 patients had glioblastoma, 10 patients had metastatic brain tumor, 31 patients had head and neck tumor, 16 patients had esophageal cancer and 14 patients had various other tumors. They were analyzed as to safety, effects on general condition besides radiosensitizing effects of misonidazole. The fractionation most often used was 1000 rad a week and a small dose of mis onidazole was given orally 4 hours before irradiation on treatment day s. The maximum total dose of misonidazole was 10 g/m/sup 2/. The plasma concentration of misonidazole was measured immediately before treatment. The mean value of plasma levels was 20.05 ..mu..g/ml. Accumulation of misonidazole in plasma was observed after its continuous administration. No severe irreversible neurotoxicites of misonidazole were observed, though 2 patients developed central nervous disorders and another 2 developed peripheral neuropathies. Radiosensitizing effect of misonidazole was not observed in 28% of the patients. But in the remaining 72%, there was a possibility of positive radiosensitizing effects of misonidazole. Prognosis was favarable in the patients with head and neck tumors on whom radiosensitizing effects of misonidazole were observed. Misonidazole had effects on initial tumor response to the treatment of pulmonary cancer, esophageal cancer and glioblastoma. Misonidazole is considered to be usefl cl inically, if it is combined with radiotherapy in the treatment of tumors that histologically have a great deal of anoxic components. But it should be emphasized that the development of more effective and less toxic radiosensitizer is necessary in clinical use.

  12. Quality assessment of reports on clinical trials in the Journal of Hepatology

    DEFF Research Database (Denmark)

    Gluud, C; Nikolova, D

    1998-01-01

    Electronic searches on databases for randomised clinical trials and controlled clinical trials do not identify as many trials as handsearches, and trial reporting may be flawed. The aims were to identify all fully reported randomised clinical trials in the Journal of Hepatology and to make a qual...... a qualitative assessment of the reporting....

  13. Bioavailability studies and the clinical pharmacologist: correlation of drug distribution with clinical effects.

    Science.gov (United States)

    Ogilvie, R I

    1975-06-01

    Bioavailability studies can be interpreted only when clinical information is available which correlates drug distribution with both efficacious and toxic clinical effects. The clinical pharmacologist should be instrumental in the development of safe and effective drug therapy by the systematic application of well designed clinical trials, the clear definition of therapeutically desirable clinical responses, and the development and application of improved techniques of measuring these effects.

  14. [Schwannoma located in the tongue. A clinical case report].

    Science.gov (United States)

    Gallesio, C; Berrone, S

    1992-12-01

    Schwannoma or neurilemmoma and neurofibroma are two tumors of the peripheral nerves originating in the nerve sheaths. Schwannoma account for just over 1% of benign tumors reported in the oral cavity. The tongue is unanimously considered the most frequent site at this level; however, the tip is the least affected part of the organ. The case of schwannoma reported here is the third observed with a lingual localization in 18 years by the Division of Maxillo-Facial Surgery of The Odontostomatological Clinic of the University of Turin. The case is of interest due the rarity of this pathology and the presence of non-significant symptoms for a presumed initial diagnosis. CASE REPORT. A 21-year-old woman was referred to our attention following the appearance two years earlier of a slowly growing swelling on the tip of the tongue. The patient complained of the fastidious presence, disturbance to mastication and phonation and occasional paresthesia of the tip of the tongue. The small mass, which was clearly evident on examination, was covered with normal mucosa. On palpation it had a hard-elastic consistency; it was slightly painful, smooth and partial mobile on surrounding levels. The patient underwent the surgical removal of the neoplasia under anesthesia. The mass was well capsulated and a good cleavage plane was easily found. The neoformation was yellowy grey, oval bean-shaped, measuring 1.9 x 1.3 x 1.1 cm. The histological diagnosis, confirmed by immunohistochemical tests, was benign Antoni's, type A schwannoma. The postoperative period was good an there was no recidivation during the course of a one-year follow-up. DISCUSSION AND CONCLUSIONS. Benign schwannoma, which are relatively rare in the oral cavity, represent a pathology which are often not taken into account during clinical practice. Symptoms which take the form of slight hypoesthesia and vague paresthesia may lead to the suspected diagnosis of this type of neoplasia. The final diagnosis is always made after a

  15. The Clinical Validity of the Process for Assessment of Effective Student Functioning.

    Science.gov (United States)

    Lambert, Nadine M.

    1981-01-01

    Reports the clinical validity of the Process for Assessment of Effective Student Functioning. A clinical team studied 300 representative second and fifth graders. Found the Process was valid for predicting independent clinical judgments of the status of these children, and located potentially handicapped children better than teacher referral.…

  16. Clinical Effects of Topical Tacrolimus on Fox-Fordyce Disease

    Directory of Open Access Journals (Sweden)

    Hilal Kaya Erdoğan

    2015-01-01

    Full Text Available Fox-Fordyce Disease (FFD is a rare, chronic, pruritic, inflammatory disorder of apocrine glands. It is characterized by dome-shaped, firm, discrete, skin-colored, and monomorphic perifollicular papules. The most common sites of involvement are axillae and anogenital and periareolar regions which are rich in apocrine sweat glands. Treatment is difficult. Topical, intralesional steroids, topical tretinoin, adapalene, clindamycin, benzoyl peroxide, oral contraceptives, isotretinoin, phototherapy, electrocauterisation, excision-liposuction and curettage, and fractional carbon dioxide laser are among the treatment options. In the literature, there are articles reporting beneficial effects of pimecrolimus in FFD. Nevertheless, there have not been any reports about the use of tacrolimus in FFD. We report two patients diagnosed with FFD by clinical and histopathologic examination and discussed therapeutic effects of topical tacrolimus on FFD in the light of literature.

  17. Clinical effects of icodextrin in peritoneal dialysis.

    Science.gov (United States)

    Cnossen, Trijntje T; Konings, Constantijn J; van der Sande, Frank M; Leunissen, Karel M; Kooman, Jeroen P

    2008-10-01

    Objective. This study reviews the relevant publications on the clinical effects of icodextrin in peritoneal dialysis (PD). Design. The study provides a systematic review of the literature (MEDLINE search with icodextrin as the keyword). Results. Icodextrin induces sustained transcapillary ultrafiltration during long dwell periods. It also stimulates increased removal of sodium by the peritoneal membrane, reduction of extracellular water (ECW) and total body water (TBW). Effects of icodextrin on blood pressure control and residual renal function are discrepant. Icodextrin induces a reduction in the formation of advanced glycation end-products, while the longitudinal changes in the peritoneal membrane transport are less prominent. Conclusions. Use of icodextrin in PD improves the sodium and fluid balance. Icodextrin is potentially more biocompatible, when compared with the conventional glucose solutions. The side effects are rare.

  18. Effectiveness of manual therapies: the UK evidence report

    OpenAIRE

    Leininger Brent; Evans Roni; Haas Mitch; Bronfort Gert; Triano Jay

    2010-01-01

    Abstract Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. Methods The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet incl...

  19. A time series analysis of the effects of financial incentives and mandatory clinical applications as interventions to improve spontaneous adverse drug reaction reporting by hospital medical staff in China.

    Science.gov (United States)

    Chang, Feng; Xi, Yue; Zhao, Jie; Zhang, Xiaojian; Lu, Yun

    2017-07-04

    Spontaneous reporting of adverse drug reactions (ADRs) in hospitals is often under-reported, which may lead to problems in patient management. This study was aimed to assess the effectiveness of a financial intervention based on a fine and a bonus for improving spontaneous reporting of ADRs by physicians in a hospital setting. This study was conducted at the First Affiliated Hospital of Zhengzhou University (China). Starting in 2009, a bonus of 20 RMB (Chinese currency) was given for each spontaneous ADR report, and a fine of 50 RMB was given for any withheld ADR report. A time series analysis using autoregressive integrated moving average models was performed to assess the changes in the total number of spontaneous ADR reports between the preintervention period (2006-2008) and during the first (2009-2011) and second (2012-2014) intervention periods. The median number of reported ADRs per year increased from 29 (range 27-72) in the preintervention period to 277 (range 199-284) in the first intervention period and to 666 in the second (range 644-691). The monthly number of reported ADRs was stable during the 3 periods: 3.56 ± 3.60/month (95% confidence interval (CI), 2.42-4.75) during the preintervention period, 21 ± 13/month (95% CI, 16.97-25.80) in the first intervention period, and 56 ± 20/month (95% CI, 48.81-62.17) in the second intervention period. A financial incentive and ADR management regulations had a significant effect on the increase of reported ADRs. © 2017 John Wiley & Sons, Ltd.

  20. Cardiovascular Protective Effects and Clinical Applications of Resveratrol.

    Science.gov (United States)

    Cho, Sanghyun; Namkoong, Kyung; Shin, Minji; Park, Jueun; Yang, Eunyeong; Ihm, Jinsoo; Thu, Vu Thi; Kim, Hyoung Kyu; Han, Jin

    2017-04-01

    Resveratrol is a naturally occurring phenol that is generated by plant species following injury or attack by bacterial and fungal pathogens. This compound was first described as the French Paradox in 1992. Later in 2003, resveratrol was reported to activate sirtuins in yeast cells. Recent experimental studies have found that resveratrol offers a variety of benefits that include both anticarcinogenic and anti-inflammatory effects in addition to the ability to reverse obesity, attenuate hyperglycemia and hyperinsulinemia, protect heart and endothelial function, and increase the life span. Multiple molecular targets are associated with the cardioprotective capabilities of resveratrol, and therefore, resveratrol has potential for a wide range of new therapeutic strategies for atherosclerosis, ischemia/reperfusion, metabolic syndrome, cardiac failure, and inflammatory alterations during aging. Expectations for application in human patients, however, suffer from a lack of sufficient clinical evidence in support of these beneficial effects. This article reviews recently reported basic research results that describe the beneficial effects of resveratrol in an attempt to condense the evidence observed in clinical trials and provide support for the future development of novel clinical therapeutics in patients with cardiovascular diseases.

  1. Clinical analysis of polycythemia after kidney transplantation: 65 cases report

    Directory of Open Access Journals (Sweden)

    Chao ZHANG

    2014-01-01

    Full Text Available Objective To analyze the clinical characteristics, risk factors, treatment and turnover of the polycythemia after kidney transplantation. Methods The clinical data of 329 renal transplantation recipients who had undergone kidney transplantation in the Transplant Center of 309 Hospital of PLA from Jan. 2008 to Jan. 2012, were retrospectively analyzed. Posttransplant erythrocytosis (PTE was found in 65 recipients (PTE group, and no PTE was found in 264 recipients (control group. The pre- and post-operative parameters, the therapeutic effect of different treatments, and outcomes were compared between PTE group and control group. Results Patients in PTE group were younger, and the ratio of males was higher compared with that of control group (P0.05. PTE incidence was higher in recipients (24.3%, n=185 who had accepted cyclosporine than those recipients (13.9%, n=144 who had accepted tacrolimus, and the difference was statistically significant (P0.05, but the relapse rate and the embolism rate due to concurrent thrombus were lower in conservative treatment group than in venesection group with statistical significance (P<0.05. Conclusion PTE is more common in male recipients with good graft function. Smoking, high nutritional status, concomitant hypertension and diabetes are the risk factors for PTE. Administration of tacrolimus may reduce the PTE incidence. Compared with venesection treatment, conservative treatment may be more effective in treating PTE with lower relapse rate and embolism rate due to concurrent thrombus. DOI: 10.11855/j.issn.0577-7402.2013.12.10

  2. Clinical and tomography evolution of frontal osteomyelitis: Case report

    Directory of Open Access Journals (Sweden)

    Raquel Crisóstomo Lima Verde1, , , , ,

    2012-01-01

    Full Text Available Introduction: The frontal osteomyelitis is a complication of rhinosinusitis which can evolve to acute or chronicle. There is inflammatory reaction by the increasing of intraosseous pressure, ischemia and local necrosis, leading to bone abscess formation. There is no drainage, it will occur detachment of the periosteum, soft tissue invasion and worsening of ischemia with subsequent bone sequestration. Method: Case report of an inpatient in an emergency service of another institution by the complication of rhinosinusitis who was referred to the Otorhinolaryngology Service of University Hospital Professor Edgard Santos of Federal University of Bahia. Case Report: Male patient, 16 years-old, presented himself to the ER of another institution with cephalea, vomits and fever which evolved to periorbital edema and frontal to the left, moving to palpebral fluctuation and frontal. Subjected to frontal and palpebral abscess drainage, with broad-spectrum antibiotic therapy with no improvement. He was referred to our service keeping edema and fluctuation in region frontal and light edema in left periorbital region. The nasal endoscopy showed edema in meatus to the left and the computerized tomography showed fronto-ethmoid sinusitis to the left and signs of frontal osteomyelitis with bone sequestration and epidural empyema. Subjected to sinasal endoscopy surgery, external Access or removal of the frontal one affected and epidural empyema drainage. Evolved to the remission of the disease. Final Considerations: Failure in the diagnosis and rhinosinusitis complication treatment can lead to sequalae and fatal complications. The diagnosis of the frontal osteomyelitis is confirmed by the clinical suspicion and confirmed by radiological examination. The surgery is indicated when the evolution is insidious, there is bone sequestration and intracranial complications.

  3. Brief clinical report: duplication of distal 17q: report of an observation.

    Science.gov (United States)

    Naccache, N F; Vianna-Morgante, A M; Richieri-Costa, A

    1984-03-01

    We describe a boy with the syndrome due to dup(17q) resulting from a paternal balanced t(12;17) (q24;q23). The comparison of the clinical findings in our patient with those previously reported shows that the dup(17q23----qter) is associated with a clinically recognizable syndrome. Anomalies present in greater than or equal to 75% of the patients were severe psychomotor retardation; short stature; microcephaly; frontal bossing and temporal retraction; widow's peak; narrow palpebral fissures; flat nasal bridge; thin upper lip overlapping thin lower lip; downturned corners of the mouth; apparently low-set, posteriorly angulated and malformed ears; low posterior hairline; widely spaced nipples; cryptorchidism; proximal limb shortness; and hyperlaxity of limb joints. The translocation carrier father of our patient had a Poland anomaly.

  4. Developing effective invasive cardiology services. Guideline report.

    Science.gov (United States)

    Ronning, P L; Franc, C W; Lewis, S J

    1988-01-01

    foundation for the development of an effective cardiology program and details the methodologies and practices necessary to implement the planning process. Included are market assessment and financial planning models, which contain sample reports and provide conceptual and factual starting points for market-specific planning in such areas as demographic and market research, equipment costs, staffing considerations, and pricing alternatives. In addition to strategic, financial, and market planning issues, the report addresses the clinical factors involved in the operation of a cardiology department.(ABSTRACT TRUNCATED AT 400 WORDS)

  5. Analysis and strategy report on overseas large-scale systematic evaluation on clinical effectiveness of acupuncture%对国外大规模针灸临床疗效系统评价报告的分析

    Institute of Scientific and Technical Information of China (English)

    李江慧; 宿杨帅; 景向红; 石宏; 陈淑莉; 张璐; 晋志高

    2011-01-01

    综合分析Cochrane Library系统评价数据库(CDSR)收录的针灸系统评价文献和部分国外发表的针灸临床系统评价文献,对其中存在的问题提出改进建议.2009年CDSR共评价67种疾病,37种已经得出初步结论.其中针灸的有效病种有7种,包括特发性头痛、慢性颈痛、青光眼、风湿性关节炎、化疗后的恶心呕吐、经皮电刺激治疗原发性痛经和膝骨关节炎,但大部分临床证据有待提高,其他30种疾病因证据不足尚不能得出结论.分析发现,已发表的大部分针灸临床系统评价研究结果认为针刺和假针刺疗效没有显著性差异,针刺的疗效相当于安慰剂疗效.因此建议加强针灸临床的科研设计,明确研究病种选择和研究目的的关系,对针灸临床研究加强过程管理和质量控制,加强针灸基础理论研究和针灸理论基本问题的实验研究,建立符合针灸临床特点的临床评价体系.%In recent years, studies of large-scale systematic evaluation on clinical effectiveness of acupuncture were carried out in overseas. The literatures were conducted in Cochrane Library and overseas journals about systematic review of clinical effectiveness of acupuncture. The Cochrane Library contained a series of systematic reviews for the treatment of 67 kinds of diseases by acupuncture in 2009. Preliminary evaluations of clinical effectiveness of acupuncture on 37 kinds of disease were conducted. The results indicated that acupuncture therapy was effective for 7 kinds of disease, such as idiopathic headache, neck disorders, glaucoma, rheumatoid arthritis, chemotherapy-induced nausea or vomiting, primary dysmenorrhoea with TENS and knee osteoarthritis with TENS.However, these studies still needimproved research designs and sufficient research evidence. The results also indicated that acupuncture was indecisive for the other 30 kinds of disease because of insufficient evidence. Through analysis, resultsof most

  6. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  7. Comparing the effectiveness of a clinical registry and a clinical data warehouse for supporting clinical trial recruitment: a case study.

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-11-13

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost.

  8. The clinical case report: a tool for hypothesis generation.

    Science.gov (United States)

    Sniderman, A D

    1996-10-01

    The clinical case report is generally limited to a description of unusual examples of the complications of disease or responses to therapy. However, it can also be used to present novel hypotheses which have been derived from individual cases. Two examples of this latter genre are presented and updated. These are Syndrome X and the stiff left atrial syndrome. In both instances, general and novel formulations were derived from single cases. With respect to Syndrome X, a hypothesis was generated that the chest pain and ST abnormalities in these patients represent excess activation of adenosine A1 receptors in the absence of myocardial ischemia. With respect to the stiff left atrial syndrome, recognition of the first case led to the recognition of the problem in many others. Now, a variant of the syndrome has been recognized in which mitral regurgitation is also present. In addition, the possibility that tricuspid annuloplasty may rescue patients dying of cardiac cachexia due to right heart failure caused by combined pressure and volume overload of the right ventricle is outlined.

  9. Building effective clinical teams in healthcare.

    Science.gov (United States)

    Ezziane, Zoheir; Maruthappu, Mahiben; Gawn, Lynsey; Thompson, Emily A; Athanasiou, Thanos; Warren, Oliver J

    2012-01-01

    This article aims to review teamwork and the creation of effective teams within healthcare. By combining research material found in management, psychology and health services research the article explores the drivers increasing the importance of teamwork, reviews the current knowledge base on how to build a team and focuses on some of the barriers to effective team performance. The simultaneous inflation of healthcare costs and necessity to improve quality of care has generated a demand for novel solutions in policy, strategy, commissioning and provider organisations. A critical, but commonly undervalued means by which quality can be improved is through structured, formalised incentivisation and development of teams, and the ability of individuals to work collectively and in collaboration. Several factors appear to contribute to the development of successful teams, including effective communication, comprehensive decision making, safety awareness and the ability to resolve conflict. Not only is strong leadership important if teams are to function effectively but the concept and importance of followership is also vital. Building effective clinical teams is difficult. The research in this area is currently limited, as is the authors' understanding of the different requirements faced by those working in different areas of the health and social care environment. This article provides a starting place for those interested in leading and developing teams of clinicians.

  10. The Consumer Reports Effectiveness Score: What Did Consumers Report?

    Science.gov (United States)

    Nielsen, Stevan Lars; Smart, David W.; Isakson, Richard L.; Worthen, Vaughn E.; Gregersen, Ann T.; Lambert, Michael J.

    2004-01-01

    From readers' ratings of satisfaction, problem resolution, and perceived emotional change during treatment, Consumer Reports magazine (CR, 1995) concluded both that psychotherapy is effective and that longer, more intensive therapy is more effective. The authors compared prospectively gathered 45-Item Outcome Questionnaire scores (OQ-45; M. J.…

  11. Clinical outcomes of the inclusion of the therapeutic drug monitoring report in the electronic clinical record

    Directory of Open Access Journals (Sweden)

    Marina Sáez Belló

    2016-12-01

    Full Text Available Objectives: To assess the inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record (ECR. Method: An observational ambispective cohort study with a duration of 149 days: PRE (retrospective, 49 days with the TDMR printed in paper, and POST (prospective, 100 days with the TDMR included in the ECR. Exclusion criteria: Patients not hospitalized, applications for Therapeutic Drug Monitoring by Critical Care and Neonatal Units, as well as monitoring with an objective other than dose adjustment. Variables: Number of TDMRs prepared, number of patients admitted with TDMR, time of delay for treatment adjustment, defined as the number of adjustments made to the treatment within over or under 24 hours from the time of TDMR preparation, and medication errors (MEs associated with said delay, as well as the degree of acceptance of the TDMR. Results: 690 TDMRs were conducted in 391 patients, 339 in PRE (n = 206 and 351 in POST (n = 185. The number of treatment modifications made in under 24 hours increased from 73.9% in PRE to 87.3% in POST [RR = 1.2 (CI95% = 0.97-1.43. We identified 35 patients with ME, 9.7% of them in PRE and 8.1% in POST (RR = 0.84 (CI95% = 0.44-1.58]. The degree of acceptance of the pharmacist recommendation increased from 53.3% in PRE to 68.3% in POST [RR = 1.3 (CI95% = 1.02- 1.62]. Conclusions: The inclusion of the Therapeutic Drug Monitoring Report (TDMR in the Electronic Clinical Record increases the degree of acceptance of recommendations, and may reduce the delay in treatment modifications, reducing MEs and improving the process quality in terms of efficacy and safety

  12. Clinical Cancer Advances 2017: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology.

    Science.gov (United States)

    Burstein, Harold J; Krilov, Lada; Aragon-Ching, Jeanny B; Baxter, Nancy N; Chiorean, E Gabriela; Chow, Warren Allen; De Groot, John Frederick; Devine, Steven Michael; DuBois, Steven G; El-Deiry, Wafik S; Epstein, Andrew S; Heymach, John; Jones, Joshua Adam; Mayer, Deborah K; Miksad, Rebecca A; Pennell, Nathan A; Sabel, Michael S; Schilsky, Richard L; Schuchter, Lynn Mara; Tung, Nadine; Winkfield, Karen Marie; Wirth, Lori J; Dizon, Don S

    2017-02-01

    A MESSAGE FROM ASCO'S PRESIDENT I am pleased to present Clinical Cancer Advances 2017, which highlights the most promising advances in patient-oriented cancer research over the past year. The report gives us an opportunity to reflect on what an exciting time it is for cancer research and how swiftly our understanding of cancer has improved. One year ago, the White House announced the national Cancer Moonshot program to accelerate progress against cancer. This shared vision of progress has reinvigorated the research community, identified new areas of scientific collaboration, and raised our ambitions regarding what may be possible beyond the progress we have already made. When I entered the field 35 years ago, I could not have imagined where we would be today. We can now detect cancer earlier, target treatments more effectively, and manage adverse effects more effectively to enable patients to live better, more fulfilling lives. Today, two of three people with cancer live at least 5 years after diagnosis, up from roughly one of two in the 1970s. This progress has resulted from decades of incremental advances that have collectively expanded our understanding of the molecular underpinnings of cancer. There is no better current example of this than ASCO's 2017 Advance of the Year: Immunotherapy 2.0. Over the last year, there has been a wave of new successes with immunotherapy. Research has proven this approach can be effective against a wide range of hard-to-treat advanced cancers previously considered intractable. Researchers are now working to identify biologic markers that can help increase the effectiveness of treatment and determine who is most likely to benefit from immunotherapy. This knowledge will enable oncologists to make evidence-based decisions so as many patients as possible might benefit from this new type of treatment. Each successive advance builds on the previous hard work of generations of basic, translational, and clinical cancer researchers

  13. Quality management tools: facilitating clinical research data integrity by utilizing specialized reports with electronic case report forms.

    Science.gov (United States)

    Trocky, N M; Fontinha, M

    2005-01-01

    Data collected throughout the course of a clinical research trial must be reviewed for accuracy and completeness continually. The Oracle Clinical (OC) data management application utilized to capture clinical data facilitates data integrity through pre-programmed validations, edit and range checks, and discrepancy management modules. These functions were not enough. Coupled with the use of specially created reports in Oracle Discoverer and Integrated Review, both ad-hoc query and reporting tools, research staff have enhanced their ability to clean, analyze and report more accurate data captured within and among Case Report Forms (eCRFs) by individual study or across multiple studies.

  14. Clinical diagnosis and treatment of necrotizing ulcerative gingivitis in the orthodontic patient. A case report.

    Directory of Open Access Journals (Sweden)

    Jesús Rodríguez-Pulido

    2016-04-01

    Full Text Available Introduction: About 0.1% of the population suffers from necrotizing ulcerative gingivitis, a disease of rapid progression and acute manifestation, which may progress to necrotizing ulcerative periodontitis and eventually to bone sequestration and loss of gingival tissue. Case report: A 21-year-old female patient undergoing orthodontic treatment for six months, diagnosed with necrotizing ulcerative gingivitis due to acute pain in the gingival tissue, spontaneous bleeding, halitosis and abundant plaque. The treatment was conservative and effective, obtaining total remission of the lesion after seven days and three months of postoperative follow-up. Conclusion: Today there are no epidemiological or clinical reports that support the relationship of necrotizing ulcerative gingivitis and orthodontic treatment. Prevention is critical to the success of the treatment, which is why the dentist should recognize the clinical features of necrotizing ulcerative gingivitis to raise awareness of its risks in the orthodontic patient.

  15. Rationale for tilted implants: FEA considerations and clinical reports.

    Science.gov (United States)

    DE Vico, G; Bonino, M; Spinelli, D; Schiavetti, R; Sannino, G; Pozzi, A; Ottria, L

    2011-07-01

    The prevalence of the elderly population, as well as life expectancy, increased in the final decades of the 20th century, as described in the World Health Organization 2004 Annual Report. The edentulous condition therefore has a negative impact on the oral health-related quality of life. Patients wearing complete dentures for many years infact, and especially in the mandible, are often unsatisfied because of the instability of the prosthesis during speaking and eating. To date dental implant treatment is well documented as a predictable treatment for partial or complete edentulism. On the other hand the rehabilitation of atrophied edentulous arches with endosseous implants (> 10 mm) in the posterior regions is often associated with anatomic problems such as bone resorption, poor bone quality, mandibular canal, and the presence of maxillary sinuses. Different procedures have been proposed to overcome these anatomic limitations. The use of tilted implants parallel to the anterior wall of the maxillary sinus or the mental foramen/inferior alveolar nerve has been proposed as a conservative solution for the treatment of the atrophic edentulous maxilla. Aim of this study was to describe, through a detailed literature review, the clinical and biomechanical rationale for tilting implants and to evaluate the long-term prognosis of immediately loaded full fixed prostheses for the treatment of edentulous patients (#35) with extreme bone atrophy rehabilited with both axial (#70) and tilted (#70) implants from 2008 to 2010. The results of the present study would suggest that this new surgical technique may reduce patient morbidity and extend the indications for immediate loading full fixed rehabilitations. This improves the predictability of treatment goal, allows for a better risk management, and provides more individual information for the patient. These are the most important aspects of this technology, which may contribute to establish higher-quality standards in

  16. Clinical Research of Status Epilepticus: a report of 224 cases

    Directory of Open Access Journals (Sweden)

    Qiang Tu

    2013-09-01

    Full Text Available Objective: To study the clinical efficacy of midazolam in the treatment of 224 patients with status epilepticus (SE. Methods: A total of 224 patients with status epilepticus (SE admitted in our hospital from October, 2010 to October, 2013 were selected and randomly divided into midazolam group (n = 144 and combination group (tranquillizer + phenobarbital (n = 80. 0.1 - 0.2 mg/ kg of midazolam were slowly given to midazolam group for 5 - 10 min while 0.3 - 0.5 mg/ kg of diazepam and 5 - 10 mg/kg of phenobarbital were intramuscularly injected to patients in combination group. Results: SE’s time was significantly controlled in midazolam group than in combination group, while it was suggested that SE children’s age, etiology, incentives, seizure type, EEG, imaging changes were independent with the short-term efficacy of SE patients (P > 0.05, and the duration of attack, treatment programs and short-term efficacy of SE were correlated (P < 0.05, according to the analysis of age, etiology, incentives, seizure type, duration of attack, laboratory examinations, the relationship between treatment and curative effect. Conclusion: Midazolam is a new BZDs drug containing some special advantages when compared with traditional ones, which is also a favorable anti-epileptic drug with high safety and reliability, rapid onset, simple application and mild toxic responses.

  17. Clinical and Hematologic Effects of T-2 Toxin in Rats

    Science.gov (United States)

    2007-11-02

    FREIREICH, E.J. (1978). Phase I clinical evaluation of anguidine. Cancer Treatment Reports, 62, 1497-1502. "PACE, J.G. (1983). Effect of T-2 mycotoxin on...R.W., JR. (1983). Viability uptake and - release of T-2 mycotoxin in Vero cells. Fed. Proc. 42, 3:1983. "" THOMPSON, W.L., and WANNEMACHER, R.W., JR...1984). Detection and quantitation of T-2 mycotoxin with a simplified protein synthesis inhibition assay. Appl. Environ. Microbiol. 48, 1176-1180

  18. Cardial myxoma associated with clinical weakness and thorombocytopenia: case report

    Directory of Open Access Journals (Sweden)

    Mahmoud Hosseinzadeh Maleki

    2013-02-01

    Full Text Available Atrial myxomas is the most prevalent benign heart tumor which is presented with a wide variety of symptoms. We introduce a case who suffered left atrial myxoma associated with clinical weakness and thorombocytopenia. The clinical symptoms of the patient rapidly disappeared one week after cardial myxoma resection.

  19. 'Cloud computing' and clinical trials: report from an ECRIN workshop.

    Science.gov (United States)

    Ohmann, Christian; Canham, Steve; Danielyan, Edgar; Robertshaw, Steve; Legré, Yannick; Clivio, Luca; Demotes, Jacques

    2015-07-29

    Growing use of cloud computing in clinical trials prompted the European Clinical Research Infrastructures Network, a European non-profit organisation established to support multinational clinical research, to organise a one-day workshop on the topic to clarify potential benefits and risks. The issues that arose in that workshop are summarised and include the following: the nature of cloud computing and the cloud computing industry; the risks in using cloud computing services now; the lack of explicit guidance on this subject, both generally and with reference to clinical trials; and some possible ways of reducing risks. There was particular interest in developing and using a European 'community cloud' specifically for academic clinical trial data. It was recognised that the day-long workshop was only the start of an ongoing process. Future discussion needs to include clarification of trial-specific regulatory requirements for cloud computing and involve representatives from the relevant regulatory bodies.

  20. Analyzing clinical trial outcomes based on incomplete daily diary reports.

    Science.gov (United States)

    Thomas, Neal; Harel, Ofer; Little, Roderick J A

    2016-07-30

    A case study is presented assessing the impact of missing data on the analysis of daily diary data from a study evaluating the effect of a drug for the treatment of insomnia. The primary analysis averaged daily diary values for each patient into a weekly variable. Following the commonly used approach, missing daily values within a week were ignored provided there was a minimum number of diary reports (i.e., at least 4). A longitudinal model was then fit with treatment, time, and patient-specific effects. A treatment effect at a pre-specified landmark time was obtained from the model. Weekly values following dropout were regarded as missing, but intermittent daily missing values were obscured. Graphical summaries and tables are presented to characterize the complex missing data patterns. We use multiple imputation for daily diary data to create completed data sets so that exactly 7 daily diary values contribute to each weekly patient average. Standard analysis methods are then applied for landmark analysis of the completed data sets, and the resulting estimates are combined using the standard multiple imputation approach. The observed data are subject to digit heaping and patterned responses (e.g., identical values for several consecutive days), which makes accurate modeling of the response data difficult. Sensitivity analyses under different modeling assumptions for the data were performed, along with pattern mixture models assessing the sensitivity to the missing at random assumption. The emphasis is on graphical displays and computational methods that can be implemented with general-purpose software. Copyright © 2016 John Wiley & Sons, Ltd.

  1. Clinical Effects of Krachaidum (Kaempferia parviflora): A Systematic Review.

    Science.gov (United States)

    Saokaew, Surasak; Wilairat, Preyanate; Raktanyakan, Paranya; Dilokthornsakul, Piyameth; Dhippayom, Teerapon; Kongkaew, Chuenjid; Sruamsiri, Rosarin; Chuthaputti, Anchalee; Chaiyakunapruk, Nathorn

    2016-09-30

    Kaempferia parviflora (Krachaidum) is a medicinal plant in the family Zingiberaceae. Its rhizome has been used as folk medicine for many centuries. A number of pharmacological studies of Krachaidum had claimed benefits for various ailments. Therefore, this study aimed to systematically search and summarize the clinical evidences of Krachaidum in all identified indications. Of 683 records identified, 7 studies were included. From current clinical trials, Krachaidum showed positive benefits but remained inconclusive since small studies were included. Even though results found that Krachaidum significantly increased hand grip strength and enhanced sexual erotic stimuli, these were based on only 2 studies and 1 study, respectively. With regard to harmful effects, we found no adverse events reported even when Krachaidum 1.35 g/day was used. Therefore, future studies of Krachaidum are needed with regards to both safety and efficacy outcomes. © The Author(s) 2016.

  2. Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review

    Directory of Open Access Journals (Sweden)

    Hart Anna

    2005-03-01

    Full Text Available Abstract Good quality clinical trials are essential to inform the best cystic fibrosis (CF management and care, by determining and comparing the effectiveness of new and existing therapies and drug delivery systems. The formal inclusion of quality of life (QoL as an outcome measure in CF clinical trials is becoming more common. Both an appropriate QoL measure and sound methodology are required in order to draw valid inferences about treatments and QoL. A review was undertaken of randomised controlled trials in cystic fibrosis where QoL was measured. EMBASE, MEDLINE and ISI Web of Science were searched to locate all full papers in the English language reporting randomised controlled trials in cystic fibrosis, published between January 1991 and December 2004. All Cochrane reviews published before December 2004 were hand searched. Papers were included if the authors had reported that they had measured QoL or well being in the trial. 16 trials were identified. The interventions investigated were: antibiotics (4; home versus hospital administration of antibiotics (1; steroids (1; mucolytic therapies (6; exercise (3 and pancreatic enzymes (1. Not one trial evaluated in this review provided conclusive results concerning QoL. This review highlights many of the pitfalls of QoL measurement in CF clinical trials and provides constructive information concerning the design and reporting of trials measuring QoL.

  3. Workshop report: Schistosomiasis vaccine clinical development and product characteristics.

    Science.gov (United States)

    Mo, Annie X; Colley, Daniel G

    2016-02-17

    A schistosomiasis vaccine meeting was organized to evaluate the utility of a vaccine in public health programs, to discuss clinical development paths, and to define basic product characteristics for desirable vaccines to be used in the context of schistosomiasis control and elimination programs. It was concluded that clinical evaluation of a schistosomiasis vaccine is feasible with appropriate trial design and tools. Some basic Preferred Product Characteristics (PPC) for a human schistosomiasis vaccine and for a veterinary vaccine for bovine use were also proposed.

  4. Management of cannabis-induced periodontitis via resective surgical therapy: A clinical report.

    Science.gov (United States)

    Momen-Heravi, Fatemeh; Kang, Philip

    2017-03-01

    There is a lack of clinical research on the potential effect of cannabis use on the periodontium as well as its effect on treatment outcomes. The aim of this case report is to illustrate the clinical presentation of periodontal disease in a young woman who was a chronic cannabis user, as well as successful treatment involving motivating the patient to quit cannabis use and undergo nonsurgical and surgical therapy. A 23-year-old woman sought care at the dental clinic for periodontal treatment. During a review of her medical history, the patient reported using cannabis frequently during a 3-year period, which coincided with the occurrence of gingival inflammation. She used cannabis in the form of cigarettes that were placed at the mandibular anterior region of her mouth for prolonged periods. Localized prominent papillary and marginal gingival enlargement of the anterior mandible were present. The mandibular anterior teeth showed localized severe chronic periodontitis. The clinicians informed the patient about the potentially detrimental consequences of continued cannabis use; she was encouraged to quit, which she did. The clinicians performed nonsurgical therapy (scaling and root planing) and osseous surgery. The treatment outcome was evaluated over 6 months; improved radiographic and clinical results were observed throughout the follow-up period. Substantial availability and usage of cannabis, specifically among young adults, requires dentists to be vigilant about clinical indications of cannabis use and to provide appropriate treatments. Behavioral modification, nonsurgical therapy, and surgical therapy offer the potential for successful management of cannabis-related periodontitis. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

  5. TEACHING CLINICAL REASONING TO PHYSIOTHERAPISTS IN SAUDI ARABIA: A THEORETICAL REPORT

    Directory of Open Access Journals (Sweden)

    Mansour Abdullah Alshehri

    2017-04-01

    Full Text Available Background: Clinical reasoning (CR is an essential skill that should be taught to all healthcare professionals. In physiotherapy, it is a cognitive process whereby physiotherapists collect and assess patient data to make a diagnosis and develop an effective treatment plan. Several teaching and learning theories have been developed and used in healthcare education. The purpose of teaching is to facilitate the learning process and the successful development of practitioners in the community. Learning is defined as a knowledge process that is developed through experience which is used to manage daily life situations. The aim of this report is to explore teaching and learning theories and strategies to teach clinical reasoning to physiotherapy students in Saudi Arabia. Discussion: Although it is challenging to completely change the teaching methods in Saudi universities due to the education system rules already in place, some modules in physiotherapy are different, as they are practical and based mainly in a clinical hospital setting. As such, certain teaching and learning theories could be employed to facilitate student teaching. Indeed, a mixed method based on several theories taking into consideration the context, culture, students’ learning styles and the type of knowledge would be most appropriate. Conclusion: There is a debate about the best theory for teaching physiotherapy students. In the context of clinical reasoning, a behaviorism approach is not suitable, in contrast, constructivism is more appropriate, and thus, Saudi physiotherapy educators should consider constructivism strategies for teaching clinical reasoning.

  6. Clinical effectiveness of acupuncture on Parkinson disease

    Science.gov (United States)

    Lee, Sook-Hyun; Lim, Sabina

    2017-01-01

    Abstract Background: Parkinson's disease (PD) is the second-most-common chronic and progressive neurodegenerative disease. The long-term use of levodopa leads to a loss of efficacy and to complications. Therefore, many patients with PD have turned to complementary therapies to help relieve their symptoms. Acupuncture is most commonly used as a complementary therapy in patients with PD. This paper presents a systematic review and meta-analysis of the effects of acupuncture for patients with PD. This study was performed to summarize and evaluate evidence regarding the effectiveness of acupuncture in the relief of PD symptoms. Methods: Seven databases, namely, MEDLINE, EMBASE, the Cochrane Library, the China National Knowledge Infrastructure [CNKI], and three Korean medical databases, were searched from their inception through August 2015 without language restrictions. Randomized controlled trials (RCTs) were included if they contained reports of acupuncture compared with no treatment and conventional treatment alone or acupuncture plus conventional treatment compared with conventional treatment alone for PD symptoms. Assessments were performed with the unified PD rating scales (UPDRS) I, II, III, and IV and the total score, the Webster scale, and effectiveness rating. Methodological quality was assessed using the Physiotherapy Evidence Database (PEDro) scale and the Cochrane risk of bias (ROB). Results: In all, 982 potentially relevant articles were identified; 25 RCTs met our inclusion criterion, 19 of 25 RCTs were high-quality studies (i.e., a score of 6 or higher). The included RCTs showed favorable results for acupuncture plus conventional treatment compared with conventional treatment alone in the UPDRS II, III, and IV and the total score. Acupuncture was effective in relieving PD symptoms compared with no treatment and conventional treatment alone, and acupuncture plus conventional treatment had a more significant effect than conventional treatment alone

  7. Crown lengthening: basic principles, indications, techniques and clinical case reports.

    Science.gov (United States)

    Yeh, Simon; Andreana, Sebastiano

    2004-11-01

    Sometimes, in order to properly restore teeth, surgical intervention in the form of a crown-lengthening procedure is required. Crown lengthening is a periodontal resective procedure, aimed at removing supporting periodontal structures to gain sound tooth structure above the alveolar crest level. Periodontal health is of paramount importance for all teeth, both sound and restored. For the restorative dentist to utilize crown lengthening, it is important to understand the concept of biologic width, indications, techniques and other principles. This article reviews these basic concepts of clinical crown lengthening and presents four clinical cases utilizing crown lengthening as an integral part of treatments, to restore teeth and their surrounding tissues to health.

  8. Transient epileptic amnesia: clinical report of a cohort of patients.

    Science.gov (United States)

    Lapenta, Leonardo; Brunetti, Valerio; Losurdo, Anna; Testani, Elisa; Giannantoni, Nadia Mariagrazia; Quaranta, Davide; Di Lazzaro, Vincenzo; Della Marca, Giacomo

    2014-07-01

    Transient epileptic amnesia is a seizure disorder, usually with onset in the middle-elderly and good response to low dosages of antiepileptic drugs. We describe the clinical, electroencephalography (EEG), and neuroimaging features of 11 patients with a temporal lobe epilepsy characterized by amnesic seizures as the sole or the main symptom. We outline the relevance of a detailed clinical history to recognize amnesic seizures and to avoid the more frequent misdiagnoses. Moreover, the response to monotherapy was usually good, although the epileptic disorder was symptomatic of acquired lesions in the majority of patients.

  9. Clinical Observation on Treatment of Auditory Hallucinosis by Electroacupuncture--A Report of 30 Cases

    Institute of Scientific and Technical Information of China (English)

    Lin Hong; Li Cheng

    2005-01-01

    @@ Auditory hallucinosis, a kind of hallucinations in sensory disturbance, is very common in psychopathic clinic. Patients with this disorder could hear sounds of different variety or nature in the absence of any appropriate external stimulus. It is especially true in patients with schizophrenia, organic psychonosema,and alcoholic psychonosema. At present, the neuroleptic agents are often used to relieve auditory hallucinosis during treatment of the mental disease,and there is not a therapy that is effective in treating auditory hallucinosis. With electro-acupuncture, the authors have treated 30 cases of auditory hallucinosis with satisfactory results. A report follows.

  10. Clinical Characteristics of Adults Reporting Repressed, Recovered, or Continuous Memories of Childhood Sexual Abuse

    Science.gov (United States)

    McNally, Richard J.; Perlman, Carol A.; Ristuccia, Carel S.; Clancy, Susan A.

    2006-01-01

    The authors assessed women and men who either reported continuous memories of their childhood sexual abuse (CSA, n = 92), reported recovering memories of CSA (n = 38), reported believing they harbored repressed memories of CSA (n = 42), or reported never having been sexually abused (n = 36). Men and women were indistinguishable on all clinical and…

  11. Interconnecting smartphone, image analysis server, and case report forms in clinical trials for automatic skin lesion tracking in clinical trials

    Science.gov (United States)

    Haak, Daniel; Doma, Aliaa; Gombert, Alexander; Deserno, Thomas M.

    2016-03-01

    Today, subject's medical data in controlled clinical trials is captured digitally in electronic case report forms (eCRFs). However, eCRFs only insufficiently support integration of subject's image data, although medical imaging is looming large in studies today. For bed-side image integration, we present a mobile application (App) that utilizes the smartphone-integrated camera. To ensure high image quality with this inexpensive consumer hardware, color reference cards are placed in the camera's field of view next to the lesion. The cards are used for automatic calibration of geometry, color, and contrast. In addition, a personalized code is read from the cards that allows subject identification. For data integration, the App is connected to an communication and image analysis server that also holds the code-study-subject relation. In a second system interconnection, web services are used to connect the smartphone with OpenClinica, an open-source, Food and Drug Administration (FDA)-approved electronic data capture (EDC) system in clinical trials. Once the photographs have been securely stored on the server, they are released automatically from the mobile device. The workflow of the system is demonstrated by an ongoing clinical trial, in which photographic documentation is frequently performed to measure the effect of wound incision management systems. All 205 images, which have been collected in the study so far, have been correctly identified and successfully integrated into the corresponding subject's eCRF. Using this system, manual steps for the study personnel are reduced, and, therefore, errors, latency and costs decreased. Our approach also increases data security and privacy.

  12. How to apply case reports in clinical practice using surrogate models via example of the trigeminocardiac reflex.

    Science.gov (United States)

    Sandu, Nora; Chowdhury, Tumul; Schaller, Bernhard J

    2016-04-06

    Case reports are an increasing source of evidence in clinical medicine. Until a few years ago, such case reports were emerged into systematic reviews and nowadays they are often fitted to the development of clinical (thinking) models. We describe this modern progress of knowledge creation by the example of the trigeminocardiac reflex that was first described in 1999 by a case series and was developed over the cause-and-effect relationship, triangulation to systematic reviews and finally to thinking models. Therefore, this editorial not only underlines the increasing and outstanding importance of (unique) case reports in current science, but also in current clinical decision-making and therefore also that of specific journals like the Journal of Medical Case Reports.

  13. Recommendations for improving the quality of reporting clinical electrochemotherapy studies based on qualitative systematic review

    DEFF Research Database (Denmark)

    Campana, LG; Clover, AJ; Valpione, S

    2016-01-01

    Electrochemotherapy is becoming a well-established treatment for malignancies of skin and non-skin origin and its use is widening across Europe. The technique was developed and optimized from solid experimental and clinical evidence. A consensus document is now warranted to formalize reporting...... studies and to provide the recommendations for reporting clinical trials on electrochemotherapy....

  14. Refsum disease. Clinical and morphological report on a case.

    Science.gov (United States)

    Savettieri, G; Camarda, R; Galatioto, S; Bonavita, V

    1982-10-01

    An atypical case of Refsum disease is reported together with the peripheral nerve morphological data. The body fluids must be assayed for phytanic acid whenever an atypical chronic peripheral neuropathy is observed.

  15. Reporting and methods in clinical prediction research: A systematic review

    NARCIS (Netherlands)

    W. Bouwmeester (Walter); N.P.A. Zuithoff (Nicolaas P.); S. Mallett (Susan); M.I. Geerlings (Miriam); Y. Vergouwe (Yvonne); E.W. Steyerberg (Ewout); D.G. Altman (Douglas); K.G.M. Moons (Karel)

    2012-01-01

    textabstractBackground: We investigated the reporting and methods of prediction studies, focusing on aims, designs, participant selection, outcomes, predictors, statistical power, statistical methods, and predictive performance measures. Methods and Findings: We used a full hand search to identify a

  16. Department of Clinical Investigation Annual Progress Report: Fiscal Year 1989

    Science.gov (United States)

    1989-01-01

    Rheumatology), Melcher WL (Rheumatology). Gout--case report of an atypical patient. (Case report article submitted to the journal Arthritis and Rheumatism ...echocardiographic evidence of left ventricular hypertrophy, resting EF ឝ%, prior doxorubicin therapy or pregnancy . All subjects will receive a baseline...89, 98 Potassium, 205 Potential, 127, 159, 188, 205 Precision-COSMET, 165 Prednimustine, 41 Prednisone, 35, 66, 77 Pregnancy , 9 239 Premarin, 75

  17. Is Internet Pornography Causing Sexual Dysfunctions? A Review with Clinical Reports

    Science.gov (United States)

    Park, Brian Y.; Wilson, Gary; Berger, Jonathan; Christman, Matthew; Reina, Bryn; Bishop, Frank; Klam, Warren P.; Doan, Andrew P.

    2016-01-01

    Traditional factors that once explained men’s sexual difficulties appear insufficient to account for the sharp rise in erectile dysfunction, delayed ejaculation, decreased sexual satisfaction, and diminished libido during partnered sex in men under 40. This review (1) considers data from multiple domains, e.g., clinical, biological (addiction/urology), psychological (sexual conditioning), sociological; and (2) presents a series of clinical reports, all with the aim of proposing a possible direction for future research of this phenomenon. Alterations to the brain's motivational system are explored as a possible etiology underlying pornography-related sexual dysfunctions. This review also considers evidence that Internet pornography’s unique properties (limitless novelty, potential for easy escalation to more extreme material, video format, etc.) may be potent enough to condition sexual arousal to aspects of Internet pornography use that do not readily transition to real-life partners, such that sex with desired partners may not register as meeting expectations and arousal declines. Clinical reports suggest that terminating Internet pornography use is sometimes sufficient to reverse negative effects, underscoring the need for extensive investigation using methodologies that have subjects remove the variable of Internet pornography use. In the interim, a simple diagnostic protocol for assessing patients with porn-induced sexual dysfunction is put forth. PMID:27527226

  18. Is Internet Pornography Causing Sexual Dysfunctions? A Review with Clinical Reports.

    Science.gov (United States)

    Park, Brian Y; Wilson, Gary; Berger, Jonathan; Christman, Matthew; Reina, Bryn; Bishop, Frank; Klam, Warren P; Doan, Andrew P

    2016-08-05

    Traditional factors that once explained men's sexual difficulties appear insufficient to account for the sharp rise in erectile dysfunction, delayed ejaculation, decreased sexual satisfaction, and diminished libido during partnered sex in men under 40. This review (1) considers data from multiple domains, e.g., clinical, biological (addiction/urology), psychological (sexual conditioning), sociological; and (2) presents a series of clinical reports, all with the aim of proposing a possible direction for future research of this phenomenon. Alterations to the brain's motivational system are explored as a possible etiology underlying pornography-related sexual dysfunctions. This review also considers evidence that Internet pornography's unique properties (limitless novelty, potential for easy escalation to more extreme material, video format, etc.) may be potent enough to condition sexual arousal to aspects of Internet pornography use that do not readily transition to real-life partners, such that sex with desired partners may not register as meeting expectations and arousal declines. Clinical reports suggest that terminating Internet pornography use is sometimes sufficient to reverse negative effects, underscoring the need for extensive investigation using methodologies that have subjects remove the variable of Internet pornography use. In the interim, a simple diagnostic protocol for assessing patients with porn-induced sexual dysfunction is put forth.

  19. Digital immediate dentures treatment: A clinical report of two patients.

    Science.gov (United States)

    Neumeier, Toni Tien; Neumeier, Harold

    2016-09-01

    The use of computer-aided engineering (CAE) and computer-aided design and computer-aided manufacturing (CAD-CAM) technology to fabricate complete dentures was introduced in 2011. Clinical procedures for digital immediate dentures can be identical to those for conventional immediate dentures and can be simplified by leaving all remaining dentition until the time of extraction and denture placement. Through the digital process, a single digital design and a definitive digital record are created which can be used to fabricate the immediate digital denture and surgical reduction guide for alveoloplasty. Digital immediate dentures can be relined using the same process as for conventional dentures. The definitive digital dentures can be fabricated with a reline impression and new centric relation record, using the existing digital immediate denture without additional clinical procedures. Providing patients with digital immediate dentures is a viable trend.

  20. Case report medical eponyms: an applied clinical informatics opportunity.

    Science.gov (United States)

    Baskaran, L N Guptha Munugoor; Greco, P J; Kaelber, D C

    2012-01-01

    Medical eponyms are medical words derived from people's names. Eponyms, especially similar sounding eponyms, may be confusing to people trying to use them because the terms themselves do not contain physiologically descriptive words about the condition they refer to. Through the use of electronic health records (EHRs), embedded applied clinical informatics tools including synonyms and pick lists that include physiologically descriptive terms associated with any eponym appearing in the EHR can significantly enhance the correct use of medical eponyms. Here we describe a case example of two similar sounding medical eponyms--Wegener's disease and Wegner's disease-- which were confused in our EHR. We describe our solution to address this specific example and our suggestions and accomplishments developing more generalized approaches to dealing with medical eponyms in EHRs. Integrating brief physiologically descriptive terms with medical eponyms provides an applied clinical informatics opportunity to improve patient care.

  1. Clinical Management of Acute Interstitial Pneumonia: A Case Report

    Directory of Open Access Journals (Sweden)

    Yang Xia

    2012-01-01

    Full Text Available We describe a 51-year-old woman who was admitted to hospital because of cough and expectoration accompanied with general fatigue and progressive dyspnea. Chest HRCT scan showed areas of ground glass attenuation, consolidation, and traction bronchiectasis in bilateral bases of lungs. BAL fluid test and transbronchial lung biopsy failed to offer insightful evidence for diagnosis. She was clinically diagnosed with acute interstitial pneumonia (AIP. Treatment with mechanical ventilation and intravenous application of methylprednisolone (80 mg/day showed poor clinical response and thus was followed by steroid pulse therapy (500 mg/day, 3 days. However, she died of respiratory dysfunction eventually. Autopsy showed diffuse alveolar damage associated with hyaline membrane formation, pulmonary interstitial, immature collagen edema, and focal type II pneumocyte hyperplasia.

  2. Babesiosis in equines in Pakistan: a clinical report

    Directory of Open Access Journals (Sweden)

    Asif Rashid

    2009-09-01

    Full Text Available Equine babesiosis is a tick-borne haematological disease of equidae that can affect acutely, subacutely and chronically. The disease is manifested by intermittent fever, anaemia, icterus and haemoglobinuria. The authors describe the clinical, haematological and therapeutic aspects of babesiosis in equines at two units in Kotley and at two units in Jehlum of the Remount Veterinary and Farms Corps (RVFC. Animals on these units showed the signs of illness. On clinical examination, intermittent temperature, increased respiratory rate, anaemia, lacrimation, conjunctivitis and pale mucous membranes were observed. Haematological examination revealed a decrease in red blood cell count and haemoglobin concentration, accompanied by an increase in total white blood cell count. Cases of babesiosis in horses were successfully treated with imidocarb dipropionate at a dose rate of 4 mg/kg body weight, administered intramuscularly four times at 72 h intervals, together with supportive therapy.

  3. ACTH adenomas transforming their clinical expression: report of 5 cases.

    Science.gov (United States)

    Zoli, Matteo; Faustini-Fustini, Marco; Mazzatenta, Diego; Marucci, Gianluca; De Carlo, Eugenio; Bacci, Antonella; Pasquini, Ernesto; Lanzino, Giuseppe; Frank, Giorgio

    2015-02-01

    OBJECT Adrenocorticotropic hormone (ACTH) adenomas have been recognized as a more aggressive and invasive subtype of pituitary adenomas. An additional and clinically relevant peculiarity of these tumors is their ability to modify their clinical expression from a silent form to Cushing disease or vice versa. The aim of this study was to review a series of patients with pituitary adenomas and analyze the clinical implications of the transformation of clinical expression in 5 cases that showed this phenomenon. METHODS The authors retrospectively reviewed a series of patients with pituitary adenoma and collected clinical, biohumoral, and neuroradiological data of those who presented with a transformation from silent ACTH adenomas to functioning tumors or vice versa. In all the cases, preoperative assessment consisted of brain MRI, ophthalmological examination, and complete baseline endocrinological investigation. In patients with clinical and/or biochemical findings suspicious for Cushing syndrome, a low-dose dexamethasone suppression test was performed to rule in or out this diagnosis. Endocrinological evaluations were repeated 1 month after surgery, 3 months after surgery, and every 6 months or annually thereafter. Ophthalmological evaluations and brain MRIs were repeated after 3 months and then every 6 or 12 months thereafter. RESULTS Five patients (2 men and 3 women) included in this series had corticotropic tumors that showed transformation from an endocrinologically silent form to manifest Cushing disease and vice versa. The mean age at presentation was 40 years (range 18-51 years). In 3 of these patients, a transformation from silent to functioning ACTH adenoma with manifest Cushing disease occurred. In 1 patient, the authors observed the transition from a functioning to a silent adenoma with spontaneous resolution of hypercortisolism. Another patient's silent adenoma "shifted" to a functioning adenoma and then regressed back to a silent form with spontaneous

  4. SeqReporter: automating next-generation sequencing result interpretation and reporting workflow in a clinical laboratory.

    Science.gov (United States)

    Roy, Somak; Durso, Mary Beth; Wald, Abigail; Nikiforov, Yuri E; Nikiforova, Marina N

    2014-01-01

    A wide repertoire of bioinformatics applications exist for next-generation sequencing data analysis; however, certain requirements of the clinical molecular laboratory limit their use: i) comprehensive report generation, ii) compatibility with existing laboratory information systems and computer operating system, iii) knowledgebase development, iv) quality management, and v) data security. SeqReporter is a web-based application developed using ASP.NET framework version 4.0. The client-side was designed using HTML5, CSS3, and Javascript. The server-side processing (VB.NET) relied on interaction with a customized SQL server 2008 R2 database. Overall, 104 cases (1062 variant calls) were analyzed by SeqReporter. Each variant call was classified into one of five report levels: i) known clinical significance, ii) uncertain clinical significance, iii) pending pathologists' review, iv) synonymous and deep intronic, and v) platform and panel-specific sequence errors. SeqReporter correctly annotated and classified 99.9% (859 of 860) of sequence variants, including 68.7% synonymous single-nucleotide variants, 28.3% nonsynonymous single-nucleotide variants, 1.7% insertions, and 1.3% deletions. One variant of potential clinical significance was re-classified after pathologist review. Laboratory information system-compatible clinical reports were generated automatically. SeqReporter also facilitated quality management activities. SeqReporter is an example of a customized and well-designed informatics solution to optimize and automate the downstream analysis of clinical next-generation sequencing data. We propose it as a model that may envisage the development of a comprehensive clinical informatics solution. Copyright © 2014 American Society for Investigative Pathology and the Association for Molecular Pathology. Published by Elsevier Inc. All rights reserved.

  5. Clinical Investigation Program. Annual Progress Report. Volume 1

    Science.gov (United States)

    1994-01-20

    conducting, and publishing ethical, scientific inquiry into clinical health problems of beneficiaries of the military health care system, to include... Acromegaly and 173 Intermediate Markers of Neoplasia (5/90) 1417 Wong, Roy COL MC. Incidence of Gastric Mucosal Injury in 174 Patients Ingesting Liquid Versus... Respiratory 225 Control Mechanisms and Nocturnal Desaturation in Diffuse Pulmonary Fibrosis (2/81) 1714 Dillard, Thomas LTC MC. Mechanisms Limiting Exercise

  6. [Dengue with unusual clinical features in an infant. Case report].

    Science.gov (United States)

    Méndez-Domínguez, Nina; Achach-Medina, Kikey; Morales-Gual, Yareni María; Gómez-Carro, Salvador

    2016-07-01

    The state of Yucatan, in Mexico, is an endemic area for dengue. During 2015, there was an unpredicted increase in the number of expected cases of dengue fever. To describe and analyse the clinical presentation, progress, and management of a case of dengue infection with non-specific clinical manifestations in an infant which resulted in a dengue shock syndrome. One month old infant admitted to hospital with a generalised rash and a history of being bitten by an insect. He was diagnosed with anaphylaxis based on clinical manifestations and anamnesis. While in hospital, he developed hypotension, tachycardia, anaemia, and respiratory distress. He was transferred to the intensive care unit, but died on the fifth day. He tested positive to dengue virus in the PCR test and for IgG antibodies using Elisa. The basic cause of death was dengue shock syndrome. Dengue fever in young infant infections may be afebrile, so it is important to suspect them appropriately in the presence of a generalised rash, tachycardia, and hypotension, in order to avoid the deadly consequences of dengue shock. Copyright © 2016 Sociedad Chilena de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Restoration of the Occlusal Vertical Dimension with an Overlay Removable Partial Denture: A Clinical Report.

    Science.gov (United States)

    Zanardi, Piero Rocha; Santos, Mayara Silva; Stegun, Roberto Chaib; Sesma, Newton; Costa, Bruno; Laganá, Dalva Cruz

    2016-10-01

    The process of tooth loss throughout life associated with severe occlusal wear may pose a challenge in the rehabilitation of partially edentulous arches. In these cases, many therapeutic procedures are necessary because each tooth must be restored to obtain the correct anatomical contour and recover the occlusal vertical dimension (OVD). A removable partial denture (RPD) with occlusal/incisal coverage, also known as an overlay RPD, is an alternative treatment option with fewer interventions, and, consequently, lower cost. This clinical report reviews the principles involved in the clinical indication for an overlay RPD, as well as the necessary planning and execution, to discuss the feasibility and clinical effectiveness of this treatment, identifying the indications, advantages, and disadvantages of this procedure through the presentation of a clinical case. The overlay RPD can be an alternative treatment for special situations involving partially edentulous arches in patients who need reestablishment of the OVD and/or realignment of the occlusal plane, and it can be used as a temporary or definitive treatment. The main advantages of this type of treatment are its simplicity, reversibility, and relatively low cost; however, further studies are needed to ensure the efficacy of this treatment option. © 2015 by the American College of Prosthodontists.

  8. Acute unintentional intoxication with paraffin in a 25-year old patient - clinical case report.

    Science.gov (United States)

    Chibishev, Andon; Simonovska, Natasa

    2014-08-01

    "Fire-breathing" or "fire-eating" is a special kind of street art where the acts are always stunning, spectacular and amazing. People exhibiting this kind of show are professionals, not rare amateurs, who use different kind of fuels, usually hydrocarbons, in order to produce a pillar of fire. Intoxications caused by ingestion or inhalation of liquid paraffin, used as a fuel while performing, are numerous and various. We present a clinical case report of a 25-year old, previously healthy, amateur "fire-breather". During October, 2010 this young men arrived at the Emergency Unit of the University Clinic for toxicology and Urgent Internal Medicine in a severe clinical condition, after his unsuccessful attempt to perform real "fire-breathing". He had fever, strong headaches, mild abdominal and chest pain and he also had difficulties breathing and persistent dry cough. The patient was extremely dyspneic with peripheral cyanosis and shortness of breath. "Fire-breathers" must be viewed as a population at risk of paraffin-induced pneumonia, which has low mortality rate, but still is related with numerous and various chronic complications. Our patient was first in a life threatening, extremely serious clinical condition which was urgently treated with appropriate vigorous and effective therapy. This therapeutic protocol led to successful full recovery of these young men, who luckily didn't exhibit any chronic complications. Copyright © 2014 Elsevier Ltd and Faculty of Forensic and Legal Medicine. All rights reserved.

  9. Clinical effects of dialectical treatment of traditional Chinese medicine for acne: a report of 100 cases%中医辨证治疗痤疮100例临床疗效观察

    Institute of Scientific and Technical Information of China (English)

    朱霞; 谢民栋; 梁剑凌

    2012-01-01

    目的 分析中医辨证治疗痤疮的临床治疗效果,评价其临床应用价值.方法 收集2011年1月至2012年1月期间我院中医皮肤科收治的痤疮患者共180例,按随机数字法分为中医组100例和西医组80例,中医组采用中医辨证治疗法按不同分型给予相应的中医配方进行治疗,西医组给予常规西药治疗,治疗后对两组临床治疗情况进行分析比较.结果 中医组治疗的有效率为91.0%,高于西医组的67.5%,差异具有统计学意义(P<0.05);中医组不良反应发生率及复发率分别为3.0%、4.4%,均低于西医组,差异均具有统计学意义(P<0.05).结论 中医辨证治疗痤疮,具有较强的针对性,其临床疗效显著,复发率低,预后良好,具有良好的临床应用价值.%Objective To analyze the clinical effect of dialectical treatment of traditional Chinese medicine (TCM) for treating acne. Methods A total of 180 patients of acne admitted to our hospital from January 2011 to January 2012 were collected and randomly divided into two group, the TCM group (n=100) and the western medicine group (n=80). Paitents in the TCM group were treated with dialectical treatment of TCM, which were given corresponding formula of TCM for treatment according to different types. Patients in the western medicine group received conventional western medicine. After treatment, the clinical efficacy of the two groups were analyzed and compared. Results The effective rate of the TCM group was 91.0%, significantly higher than 67.5% in the western medicine group (P<0.05). In the TCM group, the incidence of adverse events and recurrence rates were 3.0% and 4.4%, significantly lower than those in the western medicine group (P<0.05). Conclusion Dialectical treatment of TCM is highly targeted for treating acne, with signifiant clinical efficacy, lower recurrence rate, good prognosis.

  10. Clinical Case Reporting in the Peer-Reviewed Physical Therapy Literature: Time to Move Toward Functioning.

    Science.gov (United States)

    Davenport, Todd E

    2015-12-01

    Physical therapists increasingly are contributing clinical case reports to the health literature, which form the basis for higher quality evidence that has been incorporated into clinical practice guidelines. Yet, few resources exist to assist physical therapists with the basic mechanics and quality standards of producing a clinical case report. This situation is further complicated by the absence of uniform standards for quality in case reporting. The importance of including a concise yet comprehensive description of patient functioning in all physical therapy case reports suggest the potential appropriateness of basing quality guidelines on the World Health Organization's International Classification of Functioning Disability and Health (ICF) model. The purpose of this paper is to assist physical therapists in creating high-quality clinical case reports for the peer-reviewed literature using the ICF model as a guiding framework. Along these lines, current recommendations related to the basic mechanics of writing a successful clinical case report are reviewed, as well and a proposal for uniform clinical case reporting requirements is introduced with the aim to improve the quality and feasibility of clinical case reporting in physical therapy that are informed by the ICF model.

  11. Design and Effectiveness of a Required Pre-Clinical Simulation-based Curriculum for Fundamental Clinical Skills and Procedures

    Directory of Open Access Journals (Sweden)

    Daryl P. Lofaso

    2011-12-01

    Full Text Available For more than 20 years, medical literature has increasingly documented the need for students to learn, practice and demonstrate competence in basic clinical knowledge and skills. In 2001, the Louisiana State University Health Science Centers (LSUHSC School of Medicine – New Orleans replaced its traditional Introduction in to Clinical Medicine (ICM course with the Science and Practice of Medicine (SPM course. The main component within the SPM course is the Clinical Skills Lab (CSL. The CSL teaches 30 plus skills to all pre-clinical medical students (Years 1 and 2. Since 2002, an annual longitudinal evaluation questionnaire was distributed to all medical students targeting the skills taught in the CSL. Students were asked to rate their self- confidence (Dreyfus and Likert-type and estimate the number of times each clinical skill was performed (clinically/non-clinically. Of the 30 plus skills taught, 8 were selected for further evaluation. An analysis was performed on the eight skills selected to determine the effectiveness of the CSL. All students that participated in the CSL reported a significant improvement in self-confidence and in number performed in the clinically/non-clinically setting when compared to students that did not experience the CSL. For example, without CSL training, the percentage of students reported at the end of their second year self-perceived expertise as “novice” ranged from 21.4% (CPR to 84.7% (GU catheterization. Students who completed the two-years CSL, only 7.8% rated their self-perceived expertise at the end of the second year as “novice” and 18.8% for GU catheterization. The CSL design is not to replace real clinical patient experiences. It's to provide early exposure, medial knowledge, professionalism and opportunity to practice skills in a patient free environment.

  12. [The clinical application of zirconium-dioxide-ceramics. Case report].

    Science.gov (United States)

    Somfai, Dóra; Zsigmond, Ágnes; Károlyházy, Katalin; Kispély, Barbara; Hermann, Péter

    2015-12-01

    Due to its outstanding physical, mechanical and esthetic properties, zirconium-dioxide is one of the most popular non-metal denture, capable of surpassing PFM in most cases. The recent advances of CAD/CAM technology makes it a good alternitve. Here we show the usefulness of zirconium-dioxide in everyday dental practice through three case reports.

  13. Female genital mutilation and reporting duties for all clinical personnel.

    Science.gov (United States)

    Cropp, Gabrielle; Armstrong, Jane

    2016-07-01

    Female genital mutilation is illegal. It is now mandatory for health-care professionals to report female genital mutilation to the police. Professionals caring for women and girls of all ages must understand how female genital mutilation presents, and what action to take.

  14. Clinical management of the ectopic eruption of a maxillary first permanent molar - Case report

    Directory of Open Access Journals (Sweden)

    Roberta Angelina Gonçalves

    2012-01-01

    Full Text Available Ectopic eruption is a concept including those clinical cases in which teeth show abnormal eruption pattern and erupt ectopically, in an incorrect position. This abnormality has been pointed out in the literature for the fi rst permanent molars, mainly the maxillary ones. There is no specifi c etiological factor for this abnormality in the fi rst permanent molar, but different factors are reported. The early approach of the ectopic eruption of the fi rst permanent molar can prevent effects such as the early root resorption of the adjacent deciduous second molar and the loss of space for eruption of the premolar successor as well. The purpose of this paper was to report a ectopic eruption of a maxillary fi rst permanent molar diagnosed in a nine-year-old patient with severe root resorption of the adjacent deciduous second molar. A simple and effective therapeutic approach was implemented to treat such abnormality. This clinical case was followed until complete eruption of the premolar successor.

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

    Science.gov (United States)

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

    1995-01-01

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

  16. Proton Radiotherapy for Parameningeal Rhabdomyosarcoma: Clinical Outcomes and Late Effects

    Energy Technology Data Exchange (ETDEWEB)

    Childs, Stephanie K. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Kozak, Kevin R. [Department of Radiation Oncology, University of Wisconsin Cancer Center Johnson Creek, Madison, WI (United States); Friedmann, Alison M. [Department of Pediatric Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yeap, Beow Y. [Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J. [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States); Yock, Torunn I., E-mail: tyock@partners.org [Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)

    2012-02-01

    Purpose: To report the clinical outcome and late side effect profile of proton radiotherapy in the treatment of children with parameningeal rhabdomyosarcoma (PM-RMS). Methods and Materials: Seventeen consecutive children with PM-RMS were treated with proton radiotherapy at Massachusetts General Hospital between 1996 and 2005. We reviewed the medical records of all patients and asked referring physicians to report specific side effects of interest. Results: Median patient age at diagnosis was 3.4 years (range, 0.4-17.6). Embryonal (n = 11), alveolar (n = 4), and undifferentiated (n = 2) histologies were represented. Ten patients (59%) had intracranial extension. Median prescribed dose was 50.4 cobalt gray equivalents (GyRBE) (range, 50.4-56.0 GyRBE) delivered in 1.8-2.0-GyRBE daily fractions. Median follow-up was 5.0 years for survivors. The 5-year failure-free survival estimate was 59% (95% confidence interval, 33-79%), and overall survival estimate was 64% (95% confidence interval, 37-82%). Among the 7 patients who failed, sites of first recurrence were local only (n = 2), regional only (n = 2), distant only (n = 2), and local and distant (n = 1). Late effects related to proton radiotherapy in the 10 recurrence-free patients (median follow-up, 5 years) include failure to maintain height velocity (n = 3), endocrinopathies (n = 2), mild facial hypoplasia (n = 7), failure of permanent tooth eruption (n = 3), dental caries (n = 5), and chronic nasal/sinus congestion (n = 2). Conclusions: Proton radiotherapy for patients with PM-RMS yields tumor control and survival comparable to that in historical controls with similar poor prognostic factors. Furthermore, rates of late effects from proton radiotherapy compare favorably to published reports of photon-treated cohorts.

  17. Clinical and radiological features of nonfamilial cherubism: A case report

    OpenAIRE

    Wagel, Justyna; Łuczak, Klaudiusz; Hendrich, Barbara; Guziński, Maciej; Sąsiadek, Marek

    2012-01-01

    Summary Background: Cherubism is an uncommon hereditary benign fibro-osseous disorder characterized by bilateral enlargement of the mandible and the maxilla that presents with varying degrees of involvement and a tendency toward spontaneous remission. On radiography cherubic lesions appear as cystic multilocular radiolucencies limited to the jaw bones. Case Report: A 5-year-old boy was referred to the Department of Maxillo-Facial Surgery due to deformation of the lower and middle section of t...

  18. Reporting and methods in clinical prediction research: a systematic review.

    Directory of Open Access Journals (Sweden)

    Walter Bouwmeester

    Full Text Available BACKGROUND: We investigated the reporting and methods of prediction studies, focusing on aims, designs, participant selection, outcomes, predictors, statistical power, statistical methods, and predictive performance measures. METHODS AND FINDINGS: We used a full hand search to identify all prediction studies published in 2008 in six high impact general medical journals. We developed a comprehensive item list to systematically score conduct and reporting of the studies, based on recent recommendations for prediction research. Two reviewers independently scored the studies. We retrieved 71 papers for full text review: 51 were predictor finding studies, 14 were prediction model development studies, three addressed an external validation of a previously developed model, and three reported on a model's impact on participant outcome. Study design was unclear in 15% of studies, and a prospective cohort was used in most studies (60%. Descriptions of the participants and definitions of predictor and outcome were generally good. Despite many recommendations against doing so, continuous predictors were often dichotomized (32% of studies. The number of events per predictor as a measure of statistical power could not be determined in 67% of the studies; of the remainder, 53% had fewer than the commonly recommended value of ten events per predictor. Methods for a priori selection of candidate predictors were described in most studies (68%. A substantial number of studies relied on a p-value cut-off of p<0.05 to select predictors in the multivariable analyses (29%. Predictive model performance measures, i.e., calibration and discrimination, were reported in 12% and 27% of studies, respectively. CONCLUSIONS: The majority of prediction studies in high impact journals do not follow current methodological recommendations, limiting their reliability and applicability.

  19. Rationale for tilted implants: FEA considerations and clinical reports

    OpenAIRE

    DE VICO, G.; Bonino, M.; Spinelli,D; SCHIAVETTI, R.; Sannino, G.; Pozzi, A; OTTRIA, L.

    2012-01-01

    The prevalence of the elderly population, as well as life expectancy, increased in the final decades of the 20th century, as described in the World Health Organization 2004 Annual Report. The edentulous condition therefore has a negative impact on the oral health–related quality of life. Patients wearing complete dentures for many years infact, and especially in the mandible, are often unsatisfied because of the instability of the prosthesis during speaking and eating. To date dental implant ...

  20. Trismus as a Clinical Manifestation of Tetanus: A Case Report.

    Science.gov (United States)

    Papadiochos, Ioannis; Papadiochou, Sofia; Petsinis, Vassilis; Goutzanis, Lampros; Atsali, Charikleia; Papadogeorgaki, Nikolaos

    2016-01-01

    Although the incidence of tetanus disease has radically declined in developed countries, both dental practitioners and oral and maxillofacial surgeons should be knowledgeable about its diagnosis since initial manifestations of the disease, such as trismus and dysphagia, are observed in the orofacial region. This study reports on a case of generalized tetanus diagnosed in a middle-aged man. Before the tetanus diagnosis, the patient had sought medical advice from seven different health care professionals, including a dentist and an oral and maxillofacial surgeon. The patient reported trismus and dysphagia as his main complaints. The suspicion of tetanus emerged from the patient's manifestations in conjunction with his history of trauma and his agricultural occupation. The patient underwent successful treatment including administration of muscle relaxants, antibiotics, and booster vaccination doses of tetanus toxoid as well as a tracheostomy and aided mechanical ventilation. This case report highlights the significance of taking a meticulous medical history, thoroughly performing a physical examination, and systematically assessing orofacial signs and symptoms.

  1. INDICATIONS FOR DISTAL RADIOULNAR ARTHROPLASTY: REPORT ON THREE CLINICAL CASES

    Science.gov (United States)

    Santos, Cláudia; Pereira, Alexandre; Sousa, Marco; Trigeuiros, Miguel; Silva, César

    2015-01-01

    Distal radioulnar arthroplasty is an attractive solution for treating various pathological conditions of the distal radioulnar joint because it allows restoration of stability, load transmission and function. The main indications are: radioulnar impingement after partial or complete resection of the distal ulna; and degenerative, inflammatory or post-traumatic arthritis of the distal radioulnar joint. The authors present three clinical cases of distal radioulnar pathological conditions: two patients with post-traumatic sequelae and one case of distal radioulnar impingement after a Sauvé-Kapandji operation. The three cases were treated surgically with a metallic prosthesis to replace the distal ulna (First Choice - Ascension®). The first two were treated with a resurfacing prosthesis and the last one with a modular prosthesis. All of the patients had achieved pain relief and increased movement of the distal radioulnar joint after one year of postoperative follow-up. PMID:27047827

  2. Clinical management of supernumerary teeth: A report of two cases

    Directory of Open Access Journals (Sweden)

    Mittal M

    2010-09-01

    Full Text Available Supernumerary tooth may closely resemble the teeth of the group to which it belongs, i.e. molars, premolars or anterior teeth, or it may bear little resemblancein size or shape to which it is associated. Many complications can be associated with supernumeraries, like impaction, delayed eruption or ectopic eruption of adjacent teeth, crowding, development of median diastema and eruption into floor of the nasal cavity. This may also cause the formation of follicular cysts with significant bone destruction. Early intervention to remove it is usually required to obtain reasonable alignment and occlusal relationship. This article will present the clinical management of an (i impacted supernumerary tooth impeding the eruption of maxillary central incisor and (ii erupted supernumerary tooth with midline diastema.

  3. Conflict of interest reporting in otolaryngology clinical practice guidelines.

    Science.gov (United States)

    Sun, Gordon H

    2013-08-01

    Clinical practice guidelines (CPGs) have become increasingly important in recent years due to an increasing emphasis on evidence-based practice, as well as serious discussions in academic, medical, and legal circles about their possible role in measuring physician performance, setting provider reimbursement strategy, and establishing protection from litigation in the future. At the same time, CPGs are costly to develop. Thus, as CPGs gain influence in medical practice, it will become essential that CPGs are developed using trustworthy standards and that the authors of CPGs are not being unduly influenced by financial pressures from external stakeholders. Since 2004, the 9 CPGs sponsored by the American Academy of Otolaryngology-Head and Neck Surgery Foundation have been developed with full disclosure and appropriate management of potential financial conflicts of interest. This commentary discusses the potential for conflict of interest in otolaryngology CPGs and how the otolaryngology guideline development process can serve as a model for other professional medical organizations.

  4. Clinical and Electrophysiological Report of a Unilateral Retinitis Pigmentosa Case

    Directory of Open Access Journals (Sweden)

    Sedaghat MR

    2014-04-01

    Full Text Available Introduction: To describe clinical and electrophysiological features of a patient with unilateral Retinitis Pigmentosa (RP. Case: A 29-year-old female with a long history of progressive visual disturbance in the right eye has undergone multiple eye examinations during the past eight years. There was nothing noticeable in her past medical and ocular history. Comprehensive eye examinations were done in the first visit. All data was suggestive of right eye RP. Posterior segment fundal examination findings were: a pallor waxy disc, vessel attenuation, and extended pigmentary degeneration of the mid-peripheral retina. The left eye examination was normal. Comparing the automated 60 degree and 30 degree visual fields of both eyes obviously showed significant defects in the right eye visual field but normal in the left eye.  All of the probable infectious agents, which can cause similar ocular manifestations, were ruled out by serological tests. The standard photopic and scotopic electroretinographies were significantly reduced in amplitude in the right eye; however, they were normal in the left eye. Also, the standard Electro-Oculography (EOG results were the same as the Electro-Retinography (ERG ones in both eyes. Eye examinations were normal in other family members. Over an eight-year follow-up period, progressive deteriorating vision has gradually become more noticeable in the right eye. The left eye has been completely normal since.  This data was compatible with the Francois and Verriesr unilateral RP diagnostic criteria. Conclusion: Clinical signs and symptoms, a minimum of a five-year follow-up period, and confirmatory ERG and EOG are very helpful to diagnose andaffirm the case of unilateral RP.

  5. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

    DEFF Research Database (Denmark)

    Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn;

    2014-01-01

    OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

  6. Clinical effect of internal fixation of screw intramedullary nail in the treatment of midshaft tibia fracture: report of 13 cases.%旋入式髓内针内固定治疗胫骨中段骨折13例

    Institute of Scientific and Technical Information of China (English)

    郭岁利

    2012-01-01

    目的 观察开放复位旋入式髓内针内固定治疗胫骨中段骨折的疗效.方法 选择2009年5月至2011年5月胫骨中段骨折患者13例,采用开放复位旋入式髓内针内固定对其进行治疗,并随访6~9个月,观察临床疗效.结果 13例均达骨性愈合,膝踝关节活动范围正常;优11例,良2例,优良率100%.无髓内针断裂、松动、变形等并发症.结论 采用开放复位旋入式髓内针内固定治疗胫骨中段骨折是一种简便易行的手术方法.%Objective To observe the clinical effect of open reduction and internal fixation of screw intramedullary nail in the treatment of midshaft tibia fracture. Methods Thirteen cases of midshaft tibia fracture were treated with open reduction and internal fixation of intramedullary nail surgery. The patients were followed up for 6 to 9 months after surgery. Results All of the 13 cases reached osseous healing. The range of knee joint motion and the range of ankle joint motion were all normal. The rate of excellent and good was 100% ( excellent in 11 cases and good in 2 cases ). Conclusion Open reduction and internal fixation of intramedullary nail is a simple and feasible operation for the treatment of midshaft tibia fracture.

  7. Clinical Management of Glanzmann's Thrombasthenia: A Case Report.

    Directory of Open Access Journals (Sweden)

    Indu Varkey

    2014-04-01

    Full Text Available Glanzmann's thrombasthenia (GT is a rare, genetically inherited platelet disorder in which the platelet glycoprotein IIb/IIIa (GP IIb/IIIa complex is either deficient or, dysfunctional. The incidence is about 1 in 1,000,000. This case report deals with a 4 year-old girl diagnosed with GT presenting with dental caries and periapical lesions in the primary mandibular first molars. To provide the best care, an interdisciplinary approach was followed by a team consisting of pediatric dentists, pediatricians and anesthesiologists. Complete oral rehabilitation was planned under general anesthesia which included extractions, multiple esthetic restorations and space maintainers with the utmost care to prevent unwarranted bleeding.

  8. Clinical Management of Glanzmann's Thrombasthenia: A Case Report.

    Science.gov (United States)

    Varkey, Indu; Rai, Kavita; Hegde, Amitha M; Vijaya, Mangalpady Shenoy; Oommen, Vinod Idicula

    2014-03-01

    Glanzmann's thrombasthenia (GT) is a rare, genetically inherited platelet disorder in which the platelet glycoprotein IIb/IIIa (GP IIb/IIIa) complex is either deficient or, dysfunctional. The incidence is about 1 in 1,000,000. This case report deals with a 4 year-old girl diagnosed with GT presenting with dental caries and periapical lesions in the primary mandibular first molars. To provide the best care, an interdisciplinary approach was followed by a team consisting of pediatric dentists, pediatricians and anesthesiologists. Complete oral rehabilitation was planned under general anesthesia which included extractions, multiple esthetic restorations and space maintainers with the utmost care to prevent unwarranted bleeding.

  9. [Hereditary hemachromatosis: clinical case report and literature review].

    Science.gov (United States)

    Prochazka, Ricardo; Tagle, Martín

    2006-01-01

    Hemachromatosis is a hereditary condition, producing progressive iron overload as a result of the mutation in proteins that regulate intestinal iron absorption. It is a systemic disease with several manifestations including cirrhosis, diabetes mellitus, cardiomyopathy, joint disease and a proportion of asymptomatic patients. When it is diagnosed and treatment with phlebotomies is initiated before any organ damage is developed, the prognosis is very good, with normal survival free of manifestations. This condition is common in European populations. We report the case of a Peruvian patient of European ancestry who is asymptomatic, but has high levels of aminotransferases and elevated iron markers. Genetic testing confirmed the patient's diagnosis of hereditary hemachromatosis.

  10. Clinical Application of Taichong (LR 3) : Cases Report

    Institute of Scientific and Technical Information of China (English)

    HU De-jin

    2006-01-01

    @@ Taichong(LR 3), the source(Yuan) acupoint of the Liver Meridian, locates at the depression before the combining region of the first and second metatarsal bones on the dorsum of the foot. And it is at the lateral border of the tendon of extensor pollicis longus, where dorsal venous fete of foot, dorsal artery of the first metatarsal bone, and dorsal nerve of metatarsal bones, coming from deep peroneal nerve, and there is the medial plantar nerve, a branch of the tibial nerve, in the deep layer. The author has treated various disorders with Taichong (LR 3), and 4 cases report were as follows.

  11. Clinical effect of endoscope-assisted surgery on recurrent facial spasm(report of 19 cases)%复发性面肌痉挛神经内镜下再手术治疗的症状转归

    Institute of Scientific and Technical Information of China (English)

    蓝胜勇; 肖泉; 徐鹏

    2013-01-01

    目的 总结复发性面肌痉挛单纯神经内镜下再手术治疗的效果.方法 对19例曾行显微镜下微血管减压术治疗有效6个月以上又复发的病人,神经内镜下再行面神经手术减压术.结果 15例术后症状即消失;3例术后痉挛症状减轻,其中2例两周后消失,1例2个月后消失;1例术后症状无改善.17例获得随访,时间6~24个月,平均14个月,无复发病例.结论 神经内镜下再手术是治疗复发性面肌痉挛的安全、有效的方法.%Objective To explore the clinical effect of endoscope-assisted surgery on recurrent facial spasm.Methods The facial spasm recurred 6 months after the microvascular decompression under the operating microscope in 19 patients,of whom,17 received endoscope-assisted microvascular decompression through retrosigmoid keyhole approach once again and 2 received endoscope-assisted neurolysis.The three dimensional time of flight magnetic resonance angiography was performed in all the patients before the reoperation.Results The blood vessels responsible for the facial spasm were intraoperatively found in 17 patients.The facial nerves adhesions to the scar around them were found in 2 patients.The spasmodic symptom disappeared in 15 patients,was relieved in 3 and was unchanged in 1 immediately after the reoperation.The spasmodic symptom disappeared 2 weeks after the reoperation in 2 and 1 month after the reoperation in 1 of 3 patients in whom the symptom was relieved immediately after the reoperation.Seventeen patients were followed up from 6 to 24 months(mean,14 months)and the outcomes showed that no patient had a relapse.Conclusion The endoscope-assisted surgery is a safe and effective method to treat the recurrent facial spasm.

  12. Case Report: The Clinical Toxicity of Dimethylamine Borane

    Science.gov (United States)

    Tsan, Yu-Tse; Peng, Kai-Yu; Hung, Dong-Zong; Hu, Wei-Hsiung; Yang, Dar-Yu

    2005-01-01

    Context: Dimethylamine borane (DMAB) is a reducing agent used in nonelectric plating of semiconductors. Exposures are usually through occupational contact. We report here four cases of people who suffered from work-related exposure to DMAB. Case presentation: Three patients exposed to DMAB decontaminated immediately by drinking a lot of water; they reported dizziness, nausea, diarrhea 6–8 hr later. The other patient did not decontaminate at once, and he suffered from more severe symptoms, including dizziness, nausea, limb numbness, slurred speech, irritable mood, and ataxia 13 hr later. Magnetic resonance imaging showed symmetric lesions with hyperintensity on T2WI and FLAIR in bilateral cerebellar dantate nuclei. This patient was readmitted to the hospital due to difficulty in walking and climbing 18 days after exposure. Lower leg weakness and drop foot were found bilaterally. A nerve conduction study revealed polyneuropathy with motor-predominant axonal degeneration. This patient receives regular outpatient followups and still walks with a clumsy gait and has difficulty with hand-grasping activity. Discussion: This case study demonstrates that DMAB is highly toxic to humans through any route of exposure, and dermal absorption is the major route of neurotoxicity. DMAB induces acute cortical and cerebellar injuries and delayed peripheral neuropathy. Relevance: Further investigation of the toxic mechanism of DMAB is warranted. Early decontamination with copious water is the best current treatment for exposure to DMAB. PMID:16330364

  13. Effect of immersive workplace experience on undergraduate nurses' mental health clinical confidence.

    Science.gov (United States)

    Patterson, Christopher; Moxham, Lorna; Taylor, Ellie K; Perlman, Dana; Brighton, Renee; Sumskis, Susan; Heffernan, Tim; Lee-Bates, Benjamin

    2017-02-03

    Preregistration education needs to ensure that student nurses are properly trained with the required skills and knowledge, and have the confidence to work with people who have a mental illness. With increased attention on non-traditional mental health clinical placements, further research is required to determine the effects of non-traditional mental health clinical placements on mental health clinical confidence. The aim of the present study was to investigate the impact of a non-traditional mental health clinical placement on mental health nursing clinical confidence compared to nursing students undergoing traditional clinical placements. Using the Mental Health Nursing Clinical Confidence Scale, the study investigated the relative effects of two placement programmes on the mental health clinical confidence of 79 nursing students. The two placement programmes included a non-traditional clinical placement of Recovery Camp and a comparison group that attended traditional clinical placements. Overall, the results indicated that, for both groups, mental health placement had a significant effect on improving mean mental health clinical confidence, both immediately upon conclusion of placement and at the 3-month follow up. Students who attended Recovery Camp reported a significant positive difference, compared to the comparison group, for ratings related to communicating effectively with clients with a mental illness, having a basic knowledge of antipsychotic medications and their side-effects, and providing client education regarding the effects and side-effects of medications. The findings suggest that a unique clinical placement, such as Recovery Camp, can improve and maintain facets of mental health clinical confidence for students of nursing. © 2017 Australian College of Mental Health Nurses Inc.

  14. Clinical report of the treatment of locally advanced lung cancer.

    Science.gov (United States)

    Petrovich, Z; Mietlowski, W; Ohanian, M; Cox, J

    1977-07-01

    This paper discusses the results of the treatment of 345 patients entered in the Veterans Administration Lung Group Protocol 13L. The study was activated March 1972, and closed for the patient accesion March 1975. All patients had a histological diagnosis of primary lung cancer considered clinically non-resectable or inoperable. Patients were equally randomized into two groups, radiotherapy alone or radiotherapy with chemotherapy. The analysis of the data included: treatment regimen, radiation dose, initial performance status, performance status change, cell type, duration of survival, quality of survival and age. The strongest influence on median survival was the level of radiation dose. The small cell carcinoma patients treated with radiotherapy and chemotherapy showed significant improvement in the median survival (38.2 weeks) over the patients treated with radiotherapy alone (20.6 weeks). The patients treated with radiotherapy and chemotherapy also showed improvement in performance status more frequently than the patients treated with radiotherapy alone. Other parameters of the analysis will be presented.

  15. Department of Clinical Investigation Annual Research Progress Report, FY 1992

    Science.gov (United States)

    1992-09-30

    Kaufinan CR, Carter P1 269-70,1992. Beck RA, Mercado DL, Cardiovascular Effects of Pseudoephedrine in Medically Seguin SM, Controlled Hypertensive...naproxen 500 mg bid for one month. If not tolerated, the subject will use ibuprofen 800 mg tid. All subjects with lateral epicondylitis will wear an

  16. Clinical Investigation Program Report Control Symbol MED 300.

    Science.gov (United States)

    1982-10-01

    92820 IICOIC Jones, Frederick, Jr. E6 91T20 Sen Animal Sp, Act’g NCOIC Lohr, Edward N. SPS 92010 Chem Lab Sp Blanco , Diana T. SP5 01H20 Biological...Strains and Sprains and Other Acute Traumatic Musculo - skeletal Conditions. (T) 113 xi Year Initiated Page 1982 Effect of Hydration, Urine Acidification

  17. Clinical Management of Glanzmann’s Thrombasthenia: A Case Report

    Science.gov (United States)

    Varkey, Indu; Rai, Kavita; Hegde, Amitha M.; Vijaya, Mangalpady Shenoy; Oommen, Vinod Idicula

    2014-01-01

    Glanzmann’s thrombasthenia (GT) is a rare, genetically inherited platelet disorder in which the platelet glycoprotein IIb/IIIa (GP IIb/IIIa) complex is either deficient or, dysfunctional. The incidence is about 1 in 1,000,000. This case report deals with a 4 year-old girl diagnosed with GT presenting with dental caries and periapical lesions in the primary mandibular first molars. To provide the best care, an interdisciplinary approach was followed by a team consisting of pediatric dentists, pediatricians and anesthesiologists. Complete oral rehabilitation was planned under general anesthesia which included extractions, multiple esthetic restorations and space maintainers with the utmost care to prevent unwarranted bleeding. PMID:24910701

  18. Soft Tissue Injuries in Hungarian and Austrian Clinical Diagnostic Reports

    Directory of Open Access Journals (Sweden)

    Fogarasi-Nuber Katalin

    2013-04-01

    Full Text Available Introduction: In addition to providing first aid, primary treating doctors are required to describe and register injuries acquired in accidents and assaults. They should do this with the highest possible accuracy, as this official document is often the only documentary evidence of soft tissue injuries in case a lawsuit is filed later. Characteristics of injuries may disappear faster with the healing process of the soft tissue, making it impossible for forensic experts to deduce the weapon involved. Consequently, terminological accuracy is a prerequisite for the appropriate reconstruction of the type and severity of injuries. This study aims at analysing reports on soft tissue injuries in Hungary and Austria from the terminological point of view. It is meant to reveal inaccuracies in the use of noun phrases impairing objective and accurate forensic assessment.

  19. Maxillary peripheral keratocystic odontogenic tumor. A clinical case report

    Science.gov (United States)

    Vázquez-Romero, María del Carmen; Serrera-Figallo, María de los Angeles; Alberdi-Navarro, Javier; Cabezas-Talavero, Javier; Romero-Ruiz, Manuel-María; Aguirre-Urizar, Jose-Manuel; Gutiérrez-Pérez, Jose-Luis

    2017-01-01

    The keratocystic odontogenic tumor is a benign odontogenic cystic neoplasia characterized by its thin, squamous epithelium with superficial parakeratosis. It has the potential for infiltration and local aggressiveness and has a high rate of recurrence. This neoplasia is predominantly found in males and people of white origin. The mandible is the most frequently involved site, in particular the third molar region, mandibular angle, and ramus. It has a mandible-maxilla ratio of 2:1. Only about twenty cases of peripheral keratocystic odontogenic tumors (PKCOT) have been reported in the international literature. This study presents a case of PKCOT localized in the anterior region of the maxilla, on the vestibular side of the upper left lateral incisor and the upper left canine. The diagnosis and treatment procedures, as based on the literature, are also discussed. Key words:Odontogenic cysts, odontogenic tumors, keratocyst, keratocystic odontogenic tumor. PMID:28149484

  20. Clinical characteristics of mephedrone toxicity reported to the UK National Poisons Information Service

    Science.gov (United States)

    James, D; Adams, R D; Spears, R; Cooper, G; Lupton, D J; Thompson, J P

    2010-01-01

    Objective To describe the patterns and clinical features of toxicity related to recreational use of mephedrone and other cathinones in the UK using data collected by the National Poisons Information Service (NPIS). Methods The number of accesses to TOXBASE, the NPIS online poisons information database, details of consecutive cases uploaded onto TOXBASE and the number and details of telephone enquiries made to the NPIS by health professionals in the UK were collected for the period March 2009 to February 2010. Results Over the year of study there were 2901 TOXBASE accesses and 188 telephone enquiries relating to cathinones, the majority relating to mephedrone (TOXBASE 1664, telephone 157), with a month-on-month increase in numbers. In 131 telephone enquiries concerning mephedrone, alone or in combination with alcohol, common clinical features reported included agitation or aggression (n=32, 24%, 95% CI 18% to 33%), tachycardia (n=29, 22%, 95% CI 16% to 30%), confusion or psychosis (n=18, 14%, 95% CI 9% to 21%), chest pain (n=17, 13%, 95% CI 8% to 20%), nausea (n=15, 11%, 95% CI 7% to 18%), palpitations (n=14, 11%, 95% CI 6% to 18%), peripheral vasoconstriction (n=10, 8%, 95% CI 4% to 14%) and headache (n=7, 5%, 95% CI 2% to 11%). Convulsions were reported in four cases (3%, 95% CI 1% to 8%). One exposed person died following cardiac arrest (1%, 95% CI 0% to 4%), although subsequent investigation suggested that mephedrone was not responsible. Conclusions Toxicity associated with recreational mephedrone use is increasingly common in the UK. Sympathomimetic adverse effects are common and severe effects are also reported. Structured data collected by the NPIS may be of use in identifying trends in poisoning and in establishing toxidromes for new drugs of abuse. PMID:20798084

  1. Clinical and gross pathological findings of Johne's disease in a calf: A case report

    Directory of Open Access Journals (Sweden)

    Faez Firdaus Abdullah Jesse

    2016-09-01

    Full Text Available Objective: This case report describes a clinical case of Johne's disease (JD in a Friesian calf aging one and half years. Materials and methods: Physical examination of the calf was carried out, history of the farm as well as samples for laboratory examinations were obtained. The laboratory examinations included hematological examinations by direct wet mount, hematocrit centrifugation technique and Giemsa stain, biochemical evaluation of serum, bacterial culture and isolation from feces and aspirate from the swollen jaw. Results: Clinical history showed that the farm had a history of JD, and routine health screening revealed that one of the calves had clinical signs suggestive of Johne's disease. Physical examination of the calf revealed a lumpy jaw, enlarged bilateral pre-scapular and pre-femoral lymph nodes, while hematological and biochemical findings showed a normocytic normochromic anemia, severe leukocytosis with neutropilic left shift and lymphocytosis with hyperproteinemia characterized by hyperglobulinemia. Fecal bacterial tests showed the presence of acid fast bacilli. Based on the history and laboratory findings, the cow was diagnosed with JD. In order to ensure effective control measures, the calf was culled from the heard. Postmortem examination revealed inflamed pre-scapular and pre-femoral lymph nodes with the presence of paramphistomes in the rumen mucosa. Conclusion: Since JD is a chronic disease that lingers in livestock farms, there is need for early identification and culling of infected animal in order to limit its devastation on the farm. [J Adv Vet Anim Res 2016; 3(3.000: 292-296

  2. Multidisciplinary meetings as an effective clinical intervention.

    Science.gov (United States)

    MacCallam, Jackie; Higgins, Lisa

    2014-06-01

    When used well, multidisciplinary meetings can function in the same way as other clinical interventions to improve communication, efficiency and outcomes. They help break down barriers, manage difficult emotions, and benefit service users and staff. But it is imperative that they are well prepared, well attended, and that the purpose and agenda are agreed. It is also vital to have an efficient chair and that meetings take place in an environment where feelings can be shared openly and respected. Services should recognise and address relevant training and support requirements.

  3. Effectiveness of Harpagophytum extracts and clinical efficacy.

    Science.gov (United States)

    Chrubasik, Sigrun; Conradt, Christian; Roufogalis, Basil D

    2004-02-01

    Various preparations from Harpagophytum procumbens are used for the treatment of pain in the joints and lower back. Studies published in peer reviewed journals were examined for their clinical evidence. The studies offering preparations with 50-60 mg harpagoside in the daily dosage are of better quality and provide more reliable evidence on efficacy than a proprietary ethanol extract with half the amount of harpagoside per day. However, confirmatory studies are required for all extracts before they can gain a place in treatment guidelines.

  4. Clinical Investigation Program Report, RCS MED-300 (R-1).

    Science.gov (United States)

    1985-10-31

    Hypesensitivity with and without Iontophoresis. (0) 45 1985 The Use of Ultrasound for Diagnosis in Periodontal Bone Morphology. (0) 46 1985 The Effect of...Phase II. (C) 77 1984 SWOG 8049, The Treatment of Resected, Poor Risk Prognosis Malignant Melanoma: Stage Is Surgical Excision vs Surgical Excision...gingival tissues A pilot study. Submitted to J Periodontology. Rossmann JA, Prior RF, Fica:a A3, Koudelka BM: New periodontal attachment based on

  5. Alternative Methodologies in Research Literature Review: Links between Clinical Work and MFT Effectiveness.

    Science.gov (United States)

    Addison, Shelia M.; Sandberg, Jonathan G.; Corby, Joy; Robila, Mihaela; Platt, Jason J.

    2002-01-01

    Reviews 15 years of clinical research in three family therapy (FT) journals that provide evidence for the effectiveness of marriage and family therapy. Considers designs that are being utilized in reports on the effectiveness of various models of FT. Makes connections between research and the everyday work of clinicians to make the work more…

  6. Augmenting retention and stability of an occlusal device for a partially dentate patient using existing extracoronal attachments: a clinical report.

    Science.gov (United States)

    Al-Rowaieh, Saleh A

    2011-04-01

    Occlusal devices are a valid treatment modality in certain clinical situations. For an occlusal device to be effective, sufficient retention and stability should be derived from coverage of the occlusal and incisal surfaces of the teeth. In the absence of most or all of the posterior teeth, the effectiveness of the device could become compromised as the incisal portions of the anterior teeth are typically not conducive to adequately retaining and stabilizing the device. This clinical report describes an approach to improving the retention and stability of an occlusal device for a patient with shortened dental arches by use of the patient's existing extracoronal attachments.

  7. The rhaeadr effect in clinical phonology.

    Science.gov (United States)

    Ball, Martin J

    2014-01-01

    A distinction is drawn between Crystal's bucket theory of language processing and an overflow of effects between different linguistic levels in language production. Most of the examples are drawn from Welsh (a language of mutual interest to the author and the honoree of this issue). For that reason, it is proposed that this effect is termed the rhaeadr effect (from the Welsh for waterfall). The rhaeadr effect is illustrated with the initial consonant mutation systems of Welsh and Irish, and with data from both normal phonological (and morphophonological) development and disordered speech.

  8. Clinical effect of endovenous microwave treatment for lower limb varicose veins: a report of 63 cases%微波腔内闭合治疗大隐静脉曲张63例体会

    Institute of Scientific and Technical Information of China (English)

    张博; 梁民; 蒙锦莹; 张澜; 陈延会

    2012-01-01

    目的 探讨微波腔内闭合大隐静脉治疗静脉曲张的临床疗效.方法 将63例(73条肢体)行微波腔内闭合曲张静脉患者设为微波治疗组,58(65条肢体)例行传统剥脱术的患者设为对照组,比较两组患者手术时间、术中出血、住院时间及术后恢复情况.结果 两种方法均可有效治疗下肢静脉曲张,但微波治疗比传统手术治疗具有更短的手术时间(P<0.01)、更低的术中出血(P<0.05)、更少的手术切口(P<0.05)及更低的术后下肢瘀血发生率(P<0.05),且患者术后住院时间亦明显缩短(P<0.05).结论 微波腔内闭合术治疗下肢静脉曲张具有安全、操作简捷、创伤小、恢复快等优点.%Objective To study the clinical effect of endovenous microwave treatment (EMT) for the lower limb varicose veins. Methods Sixty-three patients with varicose veins were treated by EMT (the study group), and 58 patients with varicose veins were treated by the varicose veins stripping (the control group). The operation time, blood loss during operation, the length of hospital stay were compared between the two groups. Results The study group showed significantly shorter operation time (P<0.01), less blood loss during operation (P<0.05), less incisions (P0.05), shorter length of hospital stay and lower incidence of haemostasis than the control group (P0.05). Conclusion EMT was a safe, minimally invasive and easily operated technique for the treatment of varicose veins.

  9. Implant therapy for a patient with Down syndrome and oral habits: A clinical report.

    Science.gov (United States)

    Saponaro, Paola C; Deguchi, Toru; Lee, Damian J

    2016-09-01

    This clinical report describes prosthodontic therapy with an implant-supported partial fixed dental prosthesis for a patient with Down syndrome and concomitant oral habits, including tongue thrusting and thumb sucking.

  10. Hybrid transvaginal cholecystectomy, clinical results and patient-reported outcomes of 50 consecutive cases

    NARCIS (Netherlands)

    Boezem, P.B. van den; Velthuis, S.; Lourens, H.J.; Samlal, R.A.; Cuesta, M.A.; Sietses, C.

    2013-01-01

    OBJECTIVE: The aim of this study was to report the clinical and cosmetic results of transvaginal hybrid cholecystectomy (TVC). BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has been developed as a minimal invasive alternative for conventional laparoscopic cholecystectomy. Altho

  11. Adverse event reporting in nonpharmacologic, noninterventional pain clinical trials: ACTTION systematic review.

    Science.gov (United States)

    Hunsinger, Matthew; Smith, Shannon M; Rothstein, Daniel; McKeown, Andrew; Parkhurst, Melissa; Hertz, Sharon; Katz, Nathaniel P; Lin, Allison H; McDermott, Michael P; Rappaport, Bob A; Turk, Dennis C; Dworkin, Robert H

    2014-11-01

    Assessment of treatment safety is 1 of the primary goals of clinical trials. Organizations and working groups have created reporting guidelines for adverse events (AEs). Previous research examining AE reporting for pharmacologic clinical trials of analgesics in major pain journals found many reporting inadequacies, suggesting that analgesic trials are not adhering to existing AE reporting guidelines. The present systematic review documented AE reporting in 3 main pain journals for nonpharmacologic, noninterventional (NP/NI) trials examining pain treatments. To broaden our pool of nonpharmacologic trials, we also included trials examining acupuncture, leech therapy, and noninvasive stimulation techniques (eg, transcutaneous electrical nerve stimulation). We documented AE reporting at 2 levels of specificity using coding manuals based on the Consolidated Standards of Reporting Trials (CONSORT) harms reporting standards and Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) AE reporting checklist. We identified a number of inadequacies in AE reporting across the 3 journals. For example, using the ACTTION coding manual, we found that less than one-half of the trials reported specific AE assessment methods; approximately one-third of the trials reported withdrawals due to AEs for each study arm; and about one-fourth of the trials reported all specific AEs. We also examined differences in AE reporting across several trial characteristics, finding that AE reporting was generally more detailed in trials with patients versus those using healthy volunteers undergoing experimentally evoked pain. These results suggest that investigators conducting and reporting NP/NI clinical trials are not adequately describing the assessment and occurrence of AEs.

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  13. The Workforce Task Force report: clinical implications for neurology.

    Science.gov (United States)

    Freeman, William D; Vatz, Kenneth A; Griggs, Robert C; Pedley, Timothy

    2013-07-30

    The American Academy of Neurology Workforce Task Force (WFTF) report predicts a future shortfall of neurologists in the United States. The WFTF data also suggest that for most states, the current demand for neurologist services already exceeds the supply, and by 2025 the demand for neurologists will be even higher. This future demand is fueled by the aging of the US population, the higher health care utilization rates of neurologic services, and by a greater number of patients gaining access to the health care system due to the Patient Protection and Affordable Care Act. Uncertainties in health care delivery and patient access exist due to looming concerns about further Medicare reimbursement cuts. This uncertainty is set against a backdrop of Congressional volatility on a variety of issues, including the repeal of the sustainable growth rate for physician reimbursement. The impact of these US health care changes on the neurology workforce, future increasing demands, reimbursement, and alternative health care delivery models including accountable care organizations, nonphysician providers such as nurse practitioners and physician assistants, and teleneurology for both stroke and general neurology are discussed. The data lead to the conclusion that neurologists will need to play an even larger role in caring for the aging US population by 2025. We propose solutions to increase the availability of neurologic services in the future and provide other ways of meeting the anticipated increased demand for neurologic care.

  14. Clinical Report: Germline Mosaicism in Cornelia de Lange Syndrome

    Science.gov (United States)

    Slavin, Thomas P.; Lazebnik, Noam; Clark, Dinah M.; Vengoechea, Jaime; Cohen, Leslie; Kaur, Maninder; Konczal, Laura; Crowe, Carol A.; Corteville, Jane E.; Nowaczyk, Malgorzata J.; Byrne, Janice L.; Jackson, Laird G.; Krantz, Ian D.

    2012-01-01

    Cornelia de Lange syndrome (CdLS) is a genetic disorder associated with delayed growth, intellectual disability, limb reduction defects and characteristic facial features. Germline mosaicism has been a described mechanism for CdLS when there are several affected offspring of apparently unaffected parents. Presently, the recurrence risk for CdLS has been estimated to be as high as 1.5%; however, this figure may be an underrepresentation. We report on the molecularly defined germline mosaicism cases from a large CdLS database, representing the first large case series on germline mosaicism in CdLS. Of the 12 families, eight have been previously described; however, four have not. No one specific gene mutation, either in the NIPBL or the SMC1A gene, was associated with an increased risk for germline mosaicism. Suspected or confirmed cases of germline mosaicism in our database range from a conservative 3.4% up to 5.4% of our total cohort. In conclusion, the potential reproductive recurrence risk due to germline mosiacism should be addressed in prenatal counseling for all families who have had a previously affected pregnancy or child with CdLS. PMID:22581668

  15. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    DEFF Research Database (Denmark)

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    score (mean difference 3.24, 95% CI 2.00 to 4.48). However, the effect sizes were small, and a sensitivity analysis (with removal of one trial) showed that the number needed to treat for a Patient Global Impression of Improvement rating of "much better or very much better" was 8 (95% CI 6 to 13......Abstract Background: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse...... effects of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. Methods: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving...

  16. Development and Use of Challenge Exams for Clinical Laboratory Nursing 2: Part 2 Final Report.

    Science.gov (United States)

    Hattstaedt, Mary Jane; Isaac, Margaret M.

    The report describes the development of a set of equivalency tests for students in Nursing 2 who have had prior clinical laboratory training or experience in pediatrics, obstetrics, or geriatrics. For each of the three areas the examination packet includes: the course clinical objectives, the challenge examination objectives, a self-study guide, a…

  17. Reporting of missing data and methods used to accommodate them in recent analgesic clinical trials: ACTTION systematic review and recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; McDermott, Michael P; McKeown, Andrew; Smith, Shannon M; Williams, Mark R; Hunsinger, Matthew; Farrar, John; Turk, Dennis C; Dworkin, Robert H

    2014-09-01

    Missing data in clinical trials can bias estimates of treatment effects. Statisticians and government agencies recommend making every effort to minimize missing data. Although statistical methods are available to accommodate missing data, their validity depends on often untestable assumptions about why the data are missing. The objective of this study was to assess the frequency with which randomized clinical trials published in 3 major pain journals (ie, European Journal of Pain, Journal of Pain, and Pain) reported strategies to prevent missing data, the number of participants who completed the study (ie, completers), and statistical methods to accommodate missing data. A total of 161 randomized clinical trials investigating treatments for pain, published between 2006 and 2012, were included. Approximately two-thirds of the trials reported at least 1 method that could potentially minimize missing data, the most common being allowance of concomitant medications. Only 61% of the articles explicitly reported the number of patients who were randomized and completed the trial. Although only 14 articles reported that all randomized participants completed the study, fewer than 50% of the articles reported a statistical method to accommodate missing data. Last observation carried forward imputation was used most commonly (42%). Thirteen articles reported more than 1 method to accommodate missing data; however, the majority of methods, including last observation carried forward, were not methods currently recommended by statisticians. Authors, reviewers, and editors should prioritize proper reporting of missing data and appropriate use of methods to accommodate them so as to improve the deficiencies identified in this systematic review.

  18. Malignant PEComa: a case report with emphasis on clinical and morphological criteria

    Directory of Open Access Journals (Sweden)

    Legnini Margherita

    2011-01-01

    Full Text Available Abstract Background Malignant perivascular epitheliod cell tumor (PEComa is a very rare entity composed of distinctive perivascular epitheliod cells with variable immunoreactivity for melanocytic and muscle markers. At present this neoplasm does not have a known normal cellular counterpart and the natural history is often unpredictable. Up to now, few cases of PEComa have been described and treatment modalities are still controversial, particularly in advanced conditions. Case presentation We handled the case of a 42-year-old man with unresectable PEComa of the abdomen. A 7 cm hepatic hypodense lesion between segment V and VIII of the liver and diffuse intraperitoneal nodules of 0,3-3,5 cm along the right subcapsular hepatic region, were documented by a CT scan. Radiological images showed abnormal lymph nodes of the right internal mammary chain and anterior mediastinum. The patient underwent an explorative laparotomy for uncontrolled intrabdominal hemorrhage without a well-defined preoperative tumor diagnosis. At surgery, multiple lobulated nodules containing hemorrhagic fluid on the liver surface, peritoneum and omentum were confirmed. The procedure had a palliative intent and consisted of hemostasis, hematomas evacuation and omentectomy. The diagnosis of PEComa was made after surgery on the basis of morphological and immunohystochemical criteria. Radiological and intra operative findings suggest that the mass has an hepatic origin with diffuse involvement of hepatic capsule and suspensory ligaments. The patient received medical support care with blood and plasma transfusions. In our experience, PEComa was clinically malignant, leading to a fatal outcome 25 days after hospital admission of patient. Conclusions Here we report and discuss the peculiar clinical, radiological and morphological presentation of unresectable PEComa. Although in the majority of the reported series, PEComas show a more better prognosis, our case presents with a

  19. Effect of maternal transmissions on clinical manifestations of myotonic dystrophy

    Energy Technology Data Exchange (ETDEWEB)

    Eguchi, I.; Koike, R.; Onodera, O. [Niigata Univ. (Japan)] [and others

    1994-09-01

    The mutation of myotonic dystrophy (DM) has been identified as unstable expansions of trinucleotide CTG repeat, located on chromosome 19q13-3. Although previous investigations have emphasized the strong association of the sizes of the CTG repeat with ages of onset as well as the clinical manifestations, effects of the paternal or maternal transmissions other than CTG repeats on the clinical manifestations in DM have not been evaluated in detail. To investigate how parental transmission affect the DM phenotype, we analyzed 15 cases of paternal transmission and 25 cases of maternal transmission. We have classified DM patients into 4 clinical grades. As in accordance with previous reports, there is a good correlation on sizes of the CTG repeat with their clinical features. The sizes of the CTG repeat in congenital DM patients (4.13{plus_minus}0.221 kbp) (Mean {plus_minus}SEM), who inherited mutant genes from their mothers, were not significantly larger than those of non-congenital DM patients (3.65 {plus_minus}0.36 kbp). As it has been well established that congenital DM patients are born to affected mothers, we investigated to see if there are any parental bias on the clinical manifestations in non-congenital DM. We classified each case into 4 classes depending on the size ranges of the CTG repeat (0 to 1.5 kbp, 1.5 to 3.0 kbp, 3.0 to 4.5 kbp, 4.5 kbp<). In each group of the size ranges of the CTG repeat, the distribution of cases among grades I to III were compared between paternally and maternally transmitted cases. There were statistically significant differences in the distributions of cases among grades I to III for the size ranges of 3 to 4.5 kbp expansions (p<0.01) and over 4.5 kbp expansions (p<0.05) on {chi}{sup 2} test, respectively. The results revealed that maternally transmitted cases tend to show severe phenotypes compared to paternally transmitted ones even if they have similar sizes of CTG repeat.

  20. Report on Provider-Client Interaction From 68 Methadone Maintenance Clinics in China.

    Science.gov (United States)

    Li, Li; Comulada, W Scott; Lin, Chunqing; Lan, Chiao-Wen; Cao, Xiaobin; Wu, Zunyou

    2016-10-06

    Provider-client interaction is an integral of clinical practice and central to the delivery of high-quality medical care. This article examines factors related to the provider-client interaction in the context of methadone maintenance treatment (MMT). Data were collected from 68 MMT clinics in China. In total, 418 service providers participated in the survey. Linear mixed effects regression models were performed to identify factors associated with provider-client interaction. It was observed that negative attitude toward drug users was associated with lower level of provider-client interaction and less time spent with each client. Other factors associated with lower level of interaction included being female, being younger, being a nurse, and fewer years in medical field. Higher provider-client interaction was associated with provider reported job satisfaction. The findings of this study call for a need to address provider negative attitudes that can impact provider-client interaction and the effectiveness of MMT. Future intervention efforts targeting MMT providers should be tailored by gender, provider type, and medical experiences.

  1. Association of lumbar spine stiffness and flexion-relaxation phenomenon with patient-reported outcomes in adults with chronic low back pain - a single-arm clinical trial investigating the effects of thrust spinal manipulation.

    Science.gov (United States)

    Xia, Ting; Long, Cynthia R; Vining, Robert D; Gudavalli, Maruti R; DeVocht, James W; Kawchuk, Gregory N; Wilder, David G; Goertz, Christine M

    2017-06-09

    Spinal manipulation (SM) is used commonly for treating low back pain (LBP). Spinal stiffness is routinely assessed by clinicians performing SM. Flexion-relaxation ratio (FRR) was shown to distinguish between LBP and healthy populations. The primary objective of this study was to examine the association of these two physiological variables with patient-reported pain intensity and disability in adults with chronic LBP (>12 weeks) receiving SM. A single-arm trial provided 12 sessions of side-lying thrust SM in the lumbosacral region over 6 weeks. Inclusion criteria included 21-65 years old, Roland-Morris Disability Questionnaire (RMDQ) score ≥ 6 and numerical pain rating score ≥ 2. Spinal stiffness and FRR were assessed pre-treatment at baseline, after 2 weeks and after 6 weeks of treatment. Lumbar spine global stiffness (GS) were calculated from the force-displacement curves obtained using i) hand palpation, ii) a hand-held device, and iii) an automated indenter device. Lumbar FRR was assessed during trunk flexion-extension using surface electromyography. The primary outcomes were RMDQ and pain intensity measured by visual analog scale (VAS). Mixed-effects regression models were used to analyze the data. The mean age of the 82 participants was 45 years; 48% were female; and 84% reported LBP >1 year. The mean (standard deviation) baseline pain intensity and RMDQ were 46.1 (18.1) and 9.5 (4.3), respectively. The mean reduction (95% confidence interval) after 6 weeks in pain intensity and RMDQ were 20.1 mm (14.1 to 26.1) and 4.8 (3.7 to 5.8). There was a small change over time in the palpatory GS but not in the hand-held or automated GS, nor in FRR. The addition of each physiologic variable did not affect the model-estimated changes in VAS or RMDQ over time. There was no association seen between physiological variables and LBP intensity. Higher levels of hand-held GS at L3 and automated GS were significantly associated with higher levels of RMDQ (p

  2. The effect of the European Clinical Trials Directive on published drug research in anaesthesia.

    Science.gov (United States)

    Walker, E; Hankins, M C; White, S M

    2009-09-01

    The clinical indications for anaesthetic drugs are developed through peer-reviewed publication of clinical trials. We performed a bibliometric analysis of all human research papers reported in nine general anaesthesia journals over 6 years (n = 6489), to determine any effects of the 2004 European Clinical Trials Directive on reported drug research in anaesthesia originating from Europe and the United Kingdom. We found 89% studies involved patients and 11% volunteers. Of 3234 (50%) drug studies, 96% were phase IV (post-marketing) trials. Worldwide, the number of research papers fell by 3.6% (p European Clinical Trials Directive (5% Europe, 18% United Kingdom), and drug research papers fell by 12% (p European drug research, particularly that originating from the United Kingdom. We suggest a number of measures researchers could take in response, and we propose a simplification of the application process for phase IV clinical trials, emphasising patient risk assessment.

  3. Perceptual derailment and confabulation in the Rorschach projective technique: a clinical report

    Directory of Open Access Journals (Sweden)

    Giovanni Genovese

    2015-12-01

    Full Text Available Perceptual derailment and confabulations often appear in a subtle way, being processes addressable to the field of inner world, conditioning the diagnostic process. The present clinical report aims to explore the role of Rorschach projective technique in eliciting processes otherwise unsearchable. Psycho-diagnostics data were compared to other psychometric tests such as the MMPI-2 (Minnesota Multiphasic Personality Inventory and the POMS (Profile of Mood States at time 0 and time 1 (after six months. Among these, the exploration of the projective process was crucial to understand the patient's mental functioning, as an elective instrument,  thanks to its ambiguous nature, which leads to effectively explore both the inner world and the cognitive processes.

  4. A Simplified Technique for Orientation of a Bone Anchored Auricular Prostheses: a Clinical Report

    Directory of Open Access Journals (Sweden)

    Hussein G. El Charkawi

    2012-08-01

    Full Text Available Background: A simple technique was presented in this clinical report for orientation of a bone anchored auricular prosthesis.Methods: The proposed technique includes drawing the intact ear on a transparent celluloid paper or radiographic film and flipping it to the opposite side and relating it to the fixed anatomical features on the face of patient.Results: The drawing, by this way provides a simple and easy way to duplicate and transfer the exact size and position of the intact ear to the defect side.Conclusions: This technique provides a simple, safe, inexpensive and time saving yet, an accurate and effective surgical template that orients the craniofacial implants to the confines of the definitive auricular prosthesis. It is indicated for restoration of single missing external ear either in aplasia, injuries and total resection.

  5. Phonetics and tongue position to improve mandibular denture retention: a clinical report.

    Science.gov (United States)

    Bohnenkamp, David M; Garcia, Lily T

    2007-11-01

    The fabrication, use, and wear instructions for complete dentures are often the factors determining success. The dentist must help guide the mental attitude of the skeptical patient to foster acceptance and success of complete dentures. A "feeling of looseness" may be a condition experienced while patients learn to wear a new mandibular complete denture. Some patients may not understand the reasons given by dentists for the lack of retention of a new mandibular denture. This type of patient requires more explanation, more advice, and more instruction. A phonetic training technique, to demonstrate to the patient how to retain and stabilize the mandibular denture, may be needed for some denture patients. This article reports the clinical use of phonetics and its effect on tongue position to improve the retention and stability of a mandibular complete denture.

  6. A clinical report of Type III dens invaginatus: relevant aspects of a combined therapeutic approach.

    Science.gov (United States)

    Silva E Souza, Patricia de Almeida Rodrigues; de Almeida, Bruno Vila Nova; Tartari, Talita; Alves, Ana Claudia Braga Amoras; Tuji, Farbicio Mesquita; Silva E Souza, Mario Honorato

    2013-01-01

    Dens invaginatus is a developmental abnormality that alters dental morphology; as a result, treating this condition is a challenge for endodontic practices. This article describes how a combination of nonsurgical and surgical therapies was utilized to treat a maxillary central incisor with Type III dens invaginatus and vital pulp. The treatment plan included using computed tomography (CT) for a detailed analysis of the dental anatomy and periapical area, endodontic and surgical procedures, and a 4-year follow-up period that included periodic clinical and radiographic examinations. The follow-up examinations revealed a regression of the apical lesion and no other signs or symptoms. Based on the present case report, the authors concluded that this combination of surgical and nonsurgical approaches was effective and that CT is a valuable auxiliary tool for the study of dental anatomy.

  7. Problems in the reporting of acne clinical trials: a spot check from the 2009 Annual Evidence Update on Acne Vulgaris

    Directory of Open Access Journals (Sweden)

    Grindlay Douglas JC

    2010-07-01

    Full Text Available Abstract In the course of producing the 2009 NHS Evidence - skin disorders Annual Evidence Update on Acne Vulgaris, 25 randomised controlled trials were examined. From these, at least 12 potentially serious problems of trial reporting were identified. Several trials concluded no effect of a treatment yet they were insufficiently powered to exclude potentially useful benefits. There were examples of duplicate publication and "salami publication", as well as two trials being combined and reported as one. In some cases, an incorrect "within-groups" statistical comparison was made and one trial report omitted original efficacy data and included only P values. Both of the non-inferiority studies examined failed to pre-specify a non-inferiority margin. Trials reported as "double-blind" compared treatments that were dissimilar in appearance or had differing adverse effect profiles. In one case an intention-to-treat analysis was not performed and there was a failure to account for all of the randomized participants. Trial results were made to sound more impressive by selective outcome reporting, emphasizing the statistical significance of treatment effects that were clinically insignificant, and by the use of larger-sounding odds ratios rather than rate ratios for common events. Most of the reporting problems could have been avoided by use of the CONSORT guidelines and prospective trial registration on a public clinical trials database.

  8. 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.

  9. Radix entomolaris: 2 case reports and clinical guidelines for endodontic management.

    Science.gov (United States)

    Latha, S Jothi; Velmurugan, N; Kavitha, M; Kumar, A R Pradeep

    2014-01-01

    Variations in dental anatomy and root canal systems are often reported in the dental literature. Among them, Radix entomolaris (RE) is the presence of an additional lingual root in mandibular molars. Though RE appears relatively infrequently, knowledge of the condition will aid in its management. This article presents 2 case reports of RE and clinical guidelines for endodontic management.

  10. Accuracy of radiographer plain radiograph reporting in clinical practice: a meta-analysis.

    Science.gov (United States)

    Brealey, S; Scally, A; Hahn, S; Thomas, N; Godfrey, C; Coomarasamy, A

    2005-02-01

    To determine the accuracy of radiographer plain radiograph reporting in clinical practice. Studies were identified from electronic sources and by hand searching journals, personal communication and checking reference lists. Eligible studies assessed radiographers' plain radiograph reporting in clinical practice compared with a reference standard, and provided accuracy data to construct 2 x 2 contingency tables. Data were extracted on study eligibility and characteristics, quality and accuracy. Summary estimates of sensitivity and specificity and receiver operating characteristic curves were used to pool the accuracy data. Radiographers compared with a reference standard, report plain radiographs in clinical practice at 92.6% (95% CI: 92.0-93.2) and 97.7% (95% CI: 97.5-97.9) sensitivity and specificity, respectively. Studies that compared selectively trained radiographers and radiologists of varying seniority against a reference standard showed no evidence of a difference between radiographer and radiologist reporting accuracy of accident and emergency plain radiographs. Selectively trained radiographers were also found to report such radiographs as accurately as those not solely from accident and emergency, although some variation in reporting accuracy was found for different body areas. Training radiographers improved their accuracy when reporting normal radiographs. This study systematically synthesizes the literature to provide an evidence-base showing that radiographers can accurately report plain radiographs in clinical practice.

  11. Accuracy of radiographer plain radiograph reporting in clinical practice: a meta-analysis

    Energy Technology Data Exchange (ETDEWEB)

    Brealey, S. [Department of Health Sciences, University of York (United Kingdom)]. E-mail: sb143@york.ac.uk; Scally, A. [Division of Radiography, University of Bradford (United Kingdom); Hahn, S. [Department of Health Sciences, University of York (United Kingdom); Thomas, N. [Department of X-ray, North Manchester General Hospital (United Kingdom); Godfrey, C. [Department of Health Sciences, University of York (United Kingdom); Coomarasamy, A. [Education Resource Centre, Birmingham Women' s Hospital (United Kingdom)

    2005-02-01

    AIM: To determine the accuracy of radiographer plain radiograph reporting in clinical practice. MATERIALS AND METHODS: Studies were identified from electronic sources and by hand searching journals, personal communication and checking reference lists. Eligible studies assessed radiographers' plain radiograph reporting in clinical practice compared with a reference standard, and provided accuracy data to construct 2x2 contingency tables. Data were extracted on study eligibility and characteristics, quality and accuracy. Summary estimates of sensitivity and specificity and receiver operating characteristic curves were used to pool the accuracy data. RESULTS: Radiographers compared with a reference standard, report plain radiographs in clinical practice at 92.6% and 97.7% sensitivity and specificity, respectively. Studies that compared selectively trained radiographers and radiologists of varying seniority against a reference standard showed no evidence of a difference between radiographer and radiologist reporting accuracy of accident and emergency plain radiographs. Selectively trained radiographers were also found to report such radiographs as accurately as those not solely from accident and emergency, although some variation in reporting accuracy was found for different body areas. Training radiographers improved their accuracy when reporting normal radiographs. CONCLUSION: This study systematically synthesizes the literature to provide an evidence-base showing that radiographers can accurately report plain radiographs in clinical practice.

  12. Perceptions and Attitudes towards Medication Error Reporting in Primary Care Clinics: A Qualitative Study in Malaysia.

    Science.gov (United States)

    Samsiah, A; Othman, Noordin; Jamshed, Shazia; Hassali, Mohamed Azmi

    2016-01-01

    To explore and understand participants' perceptions and attitudes towards the reporting of medication errors (MEs). A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter's burden and benefit of reporting also were identified. Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use.

  13. Clinical effects of sirolimus treatment in patients with increased ...

    African Journals Online (AJOL)

    Tropical Journal of Pharmaceutical Research May 2016; 15 (5): 1077-1081 ... Abstract. Purpose: To observe the clinical effects of sirolimus (SRL) immunosuppressive therapy in patients with ..... Engineering Res 2010; 14(31): 5825-5828. 17.

  14. Intraductal papillary mucinous neoplasms of the pancreas: reporting clinically relevant features.

    Science.gov (United States)

    Del Chiaro, Marco; Verbeke, Caroline

    2016-11-22

    Intraductal papillary mucinous neoplasms (IPMNs) of the pancreas can exhibit a wide spectrum of macroscopic and microscopic appearances. This not only causes occasional difficulties for the reporting pathologist in distinguishing these tumours from other lesions, but is also relevant clinically. As evidence accumulates, it becomes clear that multiple macroscopic and histological features of these neoplasms are relevant to the risk for malignant transformation and, consequently, of prime importance for clinical patient management. The need for detailed reporting is therefore increasing. This review discusses the panoply of gross and microscopic features of IPMN as well as the recommendations from recent consensus meetings regarding the pathology reporting on this tumour entity.

  15. Mayo Clinic/Renal Pathology Society Consensus Report on Pathologic Classification, Diagnosis, and Reporting of GN.

    Science.gov (United States)

    Sethi, Sanjeev; Haas, Mark; Markowitz, Glen S; D'Agati, Vivette D; Rennke, Helmut G; Jennette, J Charles; Bajema, Ingeborg M; Alpers, Charles E; Chang, Anthony; Cornell, Lynn D; Cosio, Fernando G; Fogo, Agnes B; Glassock, Richard J; Hariharan, Sundaram; Kambham, Neeraja; Lager, Donna J; Leung, Nelson; Mengel, Michael; Nath, Karl A; Roberts, Ian S; Rovin, Brad H; Seshan, Surya V; Smith, Richard J H; Walker, Patrick D; Winearls, Christopher G; Appel, Gerald B; Alexander, Mariam P; Cattran, Daniel C; Casado, Carmen Avila; Cook, H Terence; De Vriese, An S; Radhakrishnan, Jai; Racusen, Lorraine C; Ronco, Pierre; Fervenza, Fernando C

    2016-05-01

    Renal pathologists and nephrologists met on February 20, 2015 to establish an etiology/pathogenesis-based system for classification and diagnosis of GN, with a major aim of standardizing the kidney biopsy report of GN. On the basis of etiology/pathogenesis, GN is classified into the following five pathogenic types, each with specific disease entities: immune-complex GN, pauci-immune GN, antiglomerular basement membrane GN, monoclonal Ig GN, and C3 glomerulopathy. The pathogenesis-based classification forms the basis of the kidney biopsy report. To standardize the report, the diagnosis consists of a primary diagnosis and a secondary diagnosis. The primary diagnosis should include the disease entity/pathogenic type (if disease entity is not known) followed in order by pattern of injury (mixed patterns may be present); score/grade/class for disease entities, such as IgA nephropathy, lupus nephritis, and ANCA GN; and additional features as detailed herein. A pattern diagnosis as the sole primary diagnosis is not recommended. Secondary diagnoses should be reported separately and include coexisting lesions that do not form the primary diagnosis. Guidelines for the report format, light microscopy, immunofluorescence microscopy, electron microscopy, and ancillary studies are also provided. In summary, this consensus report emphasizes a pathogenesis-based classification of GN and provides guidelines for the standardized reporting of GN.

  16. 78 FR 21130 - Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP...

    Science.gov (United States)

    2013-04-09

    ... Clinical Trials Reporting Program (CTRP) Database (NCI) SUMMARY: Under the provisions of Section 3507(a)(1... writing. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration... Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is...

  17. Clinical Features of Reported Ethylene Glycol Exposures in the United States.

    Science.gov (United States)

    Jobson, Meghan A; Hogan, Susan L; Maxwell, Colin S; Hu, Yichun; Hladik, Gerald A; Falk, Ronald J; Beuhler, Michael C; Pendergraft, William F

    2015-01-01

    Ethylene glycol is highly toxic and represents an important cause of poisonings worldwide. Toxicity can result in central nervous system dysfunction, cardiovascular compromise, elevated anion gap metabolic acidosis and acute kidney injury. Many states have passed laws requiring addition of the bittering agent, denatonium benzoate, to ethylene glycol solutions to reduce severity of exposures. The objectives of this study were to identify differences between unintentional and intentional exposures and to evaluate the utility of denatonium benzoate as a deterrent. Using the National Poison Data System, we performed a retrospective analysis of reported cases of ethylene glycol exposures from January 2006 to December 2013. Outcome classification was summed for intentionality and used as a basis for comparison of effect groups. There were 45,097 cases of ethylene glycol exposures resulting in 154 deaths. Individuals more likely to experience major effects or death were older, male, and presented with more severe symptoms requiring higher levels of care. Latitude and season did not correlate with increased exposures; however, there were more exposures in rural areas. Denatonium benzoate use appeared to have no effect on exposure severity or number. Deaths due to ethylene glycol exposure were uncommon; however, there were major clinical effects and more exposures in rural areas. Addition of denatonium benzoate was not associated with a reduction in exposures. Alternative means to deter ingestion are needed. These findings suggest the need to consider replacing ethylene glycol with alternative and less toxic agents.

  18. Reported characteristics of participants in physical therapy-related clinical trials.

    Science.gov (United States)

    Chevan, Julia; Haskvitz, Esther M

    2015-06-01

    The inclusion of sociodemographic and anthropometric variables in published clinical trials enables physical therapists to determine the applicability of trial results to patients in their clinics. The aim of this study was to examine the reporting of participant sociodemographic and anthropometric characteristics in published physical therapy-related clinical trials. This was a retrospective review of clinical trials from 2 samples drawn from literature applicable to physical therapy. Two reviewers independently extracted data from a random sample of 152 clinical trials from the Physiotherapy Evidence Database (PEDro) and a purposive sample of 85 clinical trials published in the journal Physical Therapy (PTJ). A database containing the occurrence of sociodemographic (age, sex, race/ethnicity, level of education, marital status) and anthropometric variables (height, weight, body mass index) in each article was created to generate descriptive statistics about both samples. Among the sociodemographic variables, at least 90% of articles reported the sex and age of trial participants. Additional sociodemographic characteristics that were reported in 20% to 26% of articles were participant level of education and participant race/ethnicity. The reporting of anthropometric data differed between the 2 samples, with body mass index being most commonly reported in the PEDro sample (48.0%) and weight being most commonly reported in the PTJ sample (38.8%). Articles reviewed were limited by year of publication (from 2008 to 2012 for PTJ articles and 2010 for clinical trials from PEDro) and to English-language-only literature. The physical therapy literature would benefit from enhanced reporting requirements for both sociodemographic and anthropometric data about participants. © 2015 American Physical Therapy Association.

  19. Patient reported outcomes (PROs) in clinical trials: is 'in-trial' guidance lacking? a systematic review.

    OpenAIRE

    Kyte, DG; Draper, H; Ives, J.; Liles, C; Gheorghe, A.; Calvert, M

    2013-01-01

    BACKGROUND: Patient reported outcomes (PROs) are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting) and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant) appears to be lacking. The purpose of this revie...

  20. Automated Classification of Selected Data Elements from Free-text Diagnostic Reports for Clinical Research.

    Science.gov (United States)

    Löpprich, Martin; Krauss, Felix; Ganzinger, Matthias; Senghas, Karsten; Riezler, Stefan; Knaup, Petra

    2016-08-05

    In the Multiple Myeloma clinical registry at Heidelberg University Hospital, most data are extracted from discharge letters. Our aim was to analyze if it is possible to make the manual documentation process more efficient by using methods of natural language processing for multiclass classification of free-text diagnostic reports to automatically document the diagnosis and state of disease of myeloma patients. The first objective was to create a corpus consisting of free-text diagnosis paragraphs of patients with multiple myeloma from German diagnostic reports, and its manual annotation of relevant data elements by documentation specialists. The second objective was to construct and evaluate a framework using different NLP methods to enable automatic multiclass classification of relevant data elements from free-text diagnostic reports. The main diagnoses paragraph was extracted from the clinical report of one third randomly selected patients of the multiple myeloma research database from Heidelberg University Hospital (in total 737 selected patients). An EDC system was setup and two data entry specialists performed independently a manual documentation of at least nine specific data elements for multiple myeloma characterization. Both data entries were compared and assessed by a third specialist and an annotated text corpus was created. A framework was constructed, consisting of a self-developed package to split multiple diagnosis sequences into several subsequences, four different preprocessing steps to normalize the input data and two classifiers: a maximum entropy classifier (MEC) and a support vector machine (SVM). In total 15 different pipelines were examined and assessed by a ten-fold cross-validation, reiterated 100 times. For quality indication the average error rate and the average F1-score were conducted. For significance testing the approximate randomization test was used. The created annotated corpus consists of 737 different diagnoses paragraphs with a

  1. Perceptions and Attitudes towards Medication Error Reporting in Primary Care Clinics: A Qualitative Study in Malaysia

    Science.gov (United States)

    Samsiah, A.; Othman, Noordin; Jamshed, Shazia; Hassali, Mohamed Azmi

    2016-01-01

    Objective To explore and understand participants’ perceptions and attitudes towards the reporting of medication errors (MEs). Methods A qualitative study using in-depth interviews of 31 healthcare practitioners from nine publicly funded, primary care clinics in three states in peninsular Malaysia was conducted for this study. The participants included family medicine specialists, doctors, pharmacists, pharmacist assistants, nurses and assistant medical officers. The interviews were audiotaped and transcribed verbatim. Analysis of the data was guided by the framework approach. Results Six themes and 28 codes were identified. Despite the availability of a reporting system, most of the participants agreed that MEs were underreported. The nature of the error plays an important role in determining the reporting. The reporting system, organisational factors, provider factors, reporter’s burden and benefit of reporting also were identified. Conclusions Healthcare practitioners in primary care clinics understood the importance of reporting MEs to improve patient safety. Their perceptions and attitudes towards reporting of MEs were influenced by many factors which affect the decision-making process of whether or not to report. Although the process is complex, it primarily is determined by the severity of the outcome of the errors. The participants voluntarily report the errors if they are familiar with the reporting system, what error to report, when to report and what form to use. PMID:27906960

  2. General practitioner's reported use of clinical guidelines for hypertension and ambulatory blood pressure.

    LENUS (Irish Health Repository)

    Flynn, E

    2012-03-01

    ABPM is an invaluable clinical tool, as it has been shown to improve blood pressure control in primary care. Many clinical guidelines for hypertension advocate ambulatory blood pressure monitoring. This study aims to quantify the use of clinical guidelines for hypertension and to explore the role of ABPM in Primary Care. A questionnaire survey was sent to GPs working in the West of Ireland. 88% (n=139) of GPs use clinical guidelines that recommend the use of ABPM. 82% (n=130) of GPs find use of clinic blood pressure monitoring insufficient for the diagnosis and monitoring of hypertension. Despite good access to ABPM, GPs report lack of remuneration, 72% (n=116), cost 68% (n=108), and lack of time, 51% (n=83) as the main limiting factors to use of ABPM. GPs recognise the clinical value of ABPM, but this study identifies definite barriers to the use of ABPM in Primary Care.

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

    Science.gov (United States)

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

    2014-03-01

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

  4. From days to hours: reporting clinically actionable variants from whole genome sequencing.

    Directory of Open Access Journals (Sweden)

    Sumit Middha

    Full Text Available As the cost of whole genome sequencing (WGS decreases, clinical laboratories will be looking at broadly adopting this technology to screen for variants of clinical significance. To fully leverage this technology in a clinical setting, results need to be reported quickly, as the turnaround rate could potentially impact patient care. The latest sequencers can sequence a whole human genome in about 24 hours. However, depending on the computing infrastructure available, the processing of data can take several days, with the majority of computing time devoted to aligning reads to genomics regions that are to date not clinically interpretable. In an attempt to accelerate the reporting of clinically actionable variants, we have investigated the utility of a multi-step alignment algorithm focused on aligning reads and calling variants in genomic regions of clinical relevance prior to processing the remaining reads on the whole genome. This iterative workflow significantly accelerates the reporting of clinically actionable variants with no loss of accuracy when compared to genotypes obtained with the OMNI SNP platform or to variants detected with a standard workflow that combines Novoalign and GATK.

  5. [Pathological nighttime fears in children: Clinical specificities and effective therapeutics].

    Science.gov (United States)

    Ducasse, D; Denis, H

    2015-09-01

    Pathological nighttime fears in children have been little studied. However, this disorder is commonly encountered in medical consultations and is discomforting and dysfunctional for both the child and the family. Most nighttime fears are part and parcel of normal development, and emanate from increasingly sophisticated cognitive development in the growing child. Thus, most children report a variety of coping strategies generally helpful in reducing their anxiety, which resolves spontaneously in the growing child. Nevertheless, in about 10% of children, nighttime fears are related to one or more anxiety disorders according to Diagnostic and Statistical Manual of Mental Disorders criteria. Then, it is estimated that severe nighttime fears and sleep problems occur in 20-30% of children. This problem is not transient and has to be treated. This study aims to review clinical features of nighttime fears and possible treatments for these patients and their families. This systematic review follows the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement guidelines. Two databases (Medline and Web of Science) were searched combining the search terms: nighttime fears AND children. English and French languages were imposed. There were no publication date or publication status limitations. Pathological nighttime fears are responsible for emotional (crying, panic, tantrums at bedtime, loss of confidence, self-disparaging negative statements, and feeling of social embarrassment) and behavioral (wandering alone in the house at night, calls for parental or sibling comfort, bed sharing with parents or siblings, light source at night, refusal to go to the toilet alone at night) disturbances. This leads to a poor quality of sleep interfering with school learning, and also affects social development and family functioning. A full assessment has to be made to eliminate organic causes, have a baseline functioning, and search for comorbid anxiety diseases

  6. STUDIES ON ANTIBACTERIAL EFFECT OF APAMARGA (ACHYRANTHES ASPERA ON MULTI-DRUG RESISTANT CLINICAL ISOLATES

    Directory of Open Access Journals (Sweden)

    Patil Usha

    2013-04-01

    Full Text Available Recent reports on emergence of multidrug resistant bacteria are cause of concern in medical world. Several ayurvedic drugs have been proved to contain the antimicrobial activity. Literature on effect of ayurvedic drugs on multidrug resistant bacterial pathogens is limited. Present study reports the antimicrobial effect of Achyranthes aspera (Apamarga crude extracts on the clinical isolates of multidrug resistant bacteria. The drug was evaluated by using phytochemical tests. Crude extracts of aqueous, methanol, ethanol and chloroform was prepared. Antibacterial activity against clinically isolated multidrug resistant bacteria belonging to groups of bacillus, citrobacter, E.coli, klebsiella, proteus and salmonella was tested. The drug showed highest efficacy against Bacillus organism while least effectiveness on Proteus spp bacteria. Results of the study conclude that the medicinal plant A. aspera might be useful against multidrug resistance in pathogens of clinical importance.

  7. Clinical Report of a 17q12 Microdeletion with Additionally Unreported Clinical Features

    Directory of Open Access Journals (Sweden)

    Jennifer L. Roberts

    2014-01-01

    Full Text Available Copy number variations involving the 17q12 region have been associated with developmental and speech delay, autism, aggression, self-injury, biting and hitting, oppositional defiance, inappropriate language, and auditory hallucinations. We present a tall-appearing 17-year-old boy with marfanoid habitus, hypermobile joints, mild scoliosis, pectus deformity, widely spaced nipples, pes cavus, autism spectrum disorder, intellectual disability, and psychiatric manifestations including physical and verbal aggression, obsessive-compulsive behaviors, and oppositional defiance. An echocardiogram showed borderline increased aortic root size. An abdominal ultrasound revealed a small pancreas, mild splenomegaly with a 1.3 cm accessory splenule, and normal kidneys and liver. A testing panel for Marfan, aneurysm, and related disorders was negative. Subsequently, a 400 K array-based comparative genomic hybridization (aCGH + SNP analysis was performed which identified a de novo suspected pathogenic deletion on chromosome 17q12 encompassing 28 genes. Despite the limited number of cases described in the literature with 17q12 rearrangements, our proband’s phenotypic features both overlap and expand on previously reported cases. Since syndrome-specific DNA sequencing studies failed to provide an explanation for this patient’s unusual habitus, we postulate that this case represents an expansion of the 17q12 microdeletion phenotype. Further analysis of the deleted interval is recommended for new genotype-phenotype correlations.

  8. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Koo John

    2003-10-01

    Full Text Available Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome measures that were used in the trials – the Dermatology Life Quality Index (DLQI, the Psoriasis Symptom Assessment (PSA Scale, and two itch measures, a Visual Analog Scale (VAS and the National Psoriasis Foundation (NPF itch measure. Methods Subjects aged 18 to 70 years with moderate to severe psoriasis for at least 6 months were recruited into the two clinical trials (n = 1095. Internal consistency reliability was evaluated for all patient reported outcomes at baseline and at 12 weeks. Construct validity was evaluated by relations among the different patient reported outcomes and between the patient reported outcomes and the clinical assessments (Psoriasis Area and Severity Index; Overall Lesion Severity Scale; Physician's Global Assessment of Change assessed at baseline and at 12 weeks, as was the change over the course of the 12 week portion of the trial. Results Internal consistency reliability ranged from 0.86 to 0.95 for the patient reported outcome measures. The patient reported outcome measures were all shown to have significant construct validity with respect to each other and with respect to the clinical assessments. The four measures also demonstrated significant responsiveness to change in underlying clinical status of the patients over the course of the trial, as measured by the independently assessed clinical outcomes. Conclusions The DLQI, the PSA, VAS, and the NPF are considered useful tools for the measurement of dermatology

  9. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

    Directory of Open Access Journals (Sweden)

    Mehrfam Khoshkhounejad

    2015-11-01

    Full Text Available Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes.

  10. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes.

    Science.gov (United States)

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes.

  11. Interpreting patient-reported outcomes from clinical trials in COPD: a discussion

    Directory of Open Access Journals (Sweden)

    Jones PW

    2016-12-01

    Full Text Available Paul W Jones,1,2 Stephen Rennard,3,4 Maggie Tabberer,5 John H Riley,2 Mitra Vahdati-Bolouri,2 Neil C Barnes2,6 1Institute for Infection and Immunity, University of London, London, 2Global Respiratory Franchise, GlaxoSmithKline, Uxbridge, UK; 3Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha, NE, USA; 4Clinical Discovery Unit, AstraZeneca, Cambridge, 5Global R&D, GlaxoSmithKline, Uxbridge, 6William Harvey Institute, Bart’s and the London School of Medicine and Dentistry, London, UK Abstract: One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique the results derived from them. Therefore, in this paper, a series of questions is posed for the practising physician to consider when reviewing the treatment effectiveness as assessed by PROs. The focus is on the St George’s Respiratory Questionnaire for worked examples, but the principles apply equally to other symptom-based questionnaires. A number of different ways of presenting PRO data are discussed, including the concept of the minimum clinically important difference, whether there is a ceiling effect to PRO results, and the strengths and weaknesses of responder analyses. Using a worked example, the value of including a placebo arm in a study is illustrated, and the influence of the study on PRO results is considered, in terms of the design, patient withdrawal, and the selection of

  12. [Effectiveness of cognitive-behavioral therapy in childhood anxiety disorders in a university psychiatric outpatient clinic].

    Science.gov (United States)

    Goletz, Hildegard; Yang, Young-Im; Suhr-Dachs, Lydia; Walter, Daniel; Döpfner, Manfred

    2013-07-01

    Only few studies have examined whether the efficacy of cognitive-behavioral therapy for childhood anxiety disorders as demonstrated in randomized controlled trials (RCTs) generalizes to clinical practice. This study examines the effectiveness of cognitive-behavioral therapy for juvenile anxiety disorders under routine care conditions in a university-based psychiatric outpatient clinic. 92 children and adolescents with parent-ratings regarding anxiety and comorbid symptoms and 61 children and adolescents with self-ratings regarding anxiety and comorbid symptoms were treated with cognitive-behavioral interventions. Pre/post mean comparisons, effect sizes, and the clinical significance of changes in symptoms were examined. The effect size for reduction of anxiety symptoms was .81 for children whose parents had completed the rating scale and .79 for children who had filled in a self-rating scale. Effect sizes for reduction of comorbid symptoms varied between .37 and .84 for parent ratings and between .21 and .62 for self-ratings. The percentage of children and adolescents who achieved clinically significant improvements in anxiety symptoms was 55.1 % according to the parent ratings and 65.7 % according to the children's self-ratings. More than 50 % of parents and children reported clinically significant improvements in comorbid symptoms. Significant reductions in both anxiety and comorbid symptoms were demonstrated over the course of cognitive-behavioral therapy of juvenile anxiety disorders in a university psychiatric outpatient clinic. The effect sizes for anxiety symptoms were found to be comparable to the effect sizes reported in RCTs. Similarly, clinically significant improvements were as frequent as the rates of remission of anxiety symptoms reported in RCTs.

  13. Evidence of the clinical effectiveness of cognitive pharmaceutical services for aged patients.

    Science.gov (United States)

    Sáez-Benito, Loreto; Fernandez-Llimos, Fernando; Feletto, Eleonora; Gastelurrutia, Miguel Angel; Martinez-Martinez, Fernando; Benrimoj, Shalom I

    2013-07-01

    cognitive pharmaceutical services (CPSs) encompass a variety of pharmacists' interventions to optimise pharmacotherapy. The clinical effectiveness of CPSs for aged patients remains controversial. to analyse and describe the evidence of the clinical effectiveness of CPSs in aged patients by means of performing a systematic review of systematic reviews. using the recommended methodology by Cochrane, a search was undertaken for systematic reviews of the clinical effectiveness of CPSs in MEDLINE, EMBASE, DOAJ, SCIELO and COCHRANE LIBRARY. Reviews were assessed using the Assessment of Multiple Systematic Reviews (AMSTAR) instrument. Quality of the evidence in the reviews was ranked using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. a total of 14 systematic reviews and one meta-analysis were analysed. The overall quality of the reviews was moderate. High and moderate strength of evidence was found for the positive effect of certain CPSs on reducing the number and improving the appropriateness of medicines. There was conflicting evidence of the effect on adherence. There was limited evidence of high and moderate strength on clinical outcomes. No positive evidence was found on mortality, hospitalisations, functional capacity and cognitive function. No systematic reviews reported the effect on the level of control of health problems. certain types of CPSs reduce the number of medicines and improve the appropriateness of prescriptions. Longer follow-up periods and/or the use of surrogate clinical variables measuring the short-term impact are required to demonstrate the effect on clinical outcomes.

  14. Usage report of pharmacopuncture in musculoskeletal patients visiting Korean medicine hospitals and clinics in Korea

    OpenAIRE

    Lee, Yoon Jae; Shin, Joon-Shik; Lee, Jinho; Kim, Me-Riong; Park, Ki Byung; Lee, Hwa Dong; Lee, Yoonmi; Hong, Jungwan; Ha, In-Hyuk

    2016-01-01

    Background Pharmacopuncture is a relatively new acupuncture therapy combining acupuncture with herbal medicine. While pharmacopuncture is applied extensively in Korean medicine treatment, there are no clinical reports regarding what types of pharmacopuncture are used for which diseases. Methods Data was extracted retrospectively from the electronic medical records of all inpatients and outpatients at 12 Korean medicine hospitals and clinics during the period of December 17, 2010 to October 2,...

  15. Training clinicians in how to use patient-reported outcome measures in routine clinical practice

    OpenAIRE

    Santana, MJ; Haverman, L; Absolom, K; Takeuchi, E.; Feeny, D; Grootenhuis, M; Velikova, G

    2015-01-01

    Introduction: Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor ...

  16. Chiral Magnetic Effect Task Force Report

    CERN Document Server

    Skokov, Vladimir; Koch, Volker; Schlichting, Soeren; Thomas, Jim; Voloshin, Sergei; Wang, Gang; Yee, Ho-Ung

    2016-01-01

    In this report, we briefly examine the current status of the study of the chiral magnetic effect including theory and experimental progress. We recommend future strategies for resolving uncertainties in interpretation including recommendations for theoretical work, recommendations for measurements based on data collected in the past five years, and recommendations for beam use in the coming years of RHIC. We have specifically investigated the case for colliding nuclear isobars (nuclei with the same mass but different charge) and find the case compelling. We recommend that a program of nuclear isobar collisions to isolate the chiral magnetic effect from background sources be placed as a high priority item in the strategy for completing the RHIC mission.

  17. [Method for direct generation data for formatted case report forms based on requirement for data authenticity in actual clinical conditions].

    Science.gov (United States)

    Shao, Ming-Yi; Liu, Bao-Yan; He, Li-Yun; Zhang, Run-Shun

    2013-04-01

    Data authenticity is the basic requirement of clinical studies. In actual clinical conditions how to establish formatted case report forms (CRF) in line with the requirement for data authenticity is the key to ensure clinical data quality. On the basis of the characteristics of clinical data in actual clinical conditions, we determined elements for establishing formatted case report forms by comparing differences in data characteristics of CRFs in traditional clinical studies and in actual clinical conditions, and then generated formatted case report forms in line with the requirement for data authenticity in actual clinical conditions. The data of formatted CRFs generated in this study could not only meet the requirement for data authenticity of clinical studies in actual clinical conditions, but also comply with data management practices for clinical studies, thus it is deemed as a progress in technical methods.

  18. Nootropic (medhya) effect of Bhāvita Śaṇkhapuṣpī tablets: A clinical appraisal

    OpenAIRE

    2014-01-01

    Background: Nootropic (medhya) potential of śaṅkhapuṣpī (Convolvulus pluricaulis Choisy.) is reported in Ayurvedic literature and modern studies are now validating the same. In spite of plentiful preclinical researches already carried out during the past decades, only meager clinical efforts exploring its nootropic activity have been reported. Present clinical study is an attempt to evaluate the nootropic effect of Śaṅkhapuṣpī tablets. Aims and Objective: To evaluate the nootropic effect ...

  19. Research and clinical aspects of the late effects of poliomyelitis

    Energy Technology Data Exchange (ETDEWEB)

    Halstead, L.S.; Wiechers, D.O.

    1986-01-01

    This book contains 32 selections. Some of the titles are: Late effects of Polio: Historical Perspectives; Sleep-Disordered Breathing as a Late Effect of Poliomyelitis; Clinical Subtypes, DNA Repair Efficiency, and Therapeutic Trials in the Post-Polio Syndromes; and Post-Polio Muscle Function.

  20. Measuring Effects on the Clinical Practice from a Configured EHR

    DEFF Research Database (Denmark)

    Møller-Jensen, John; Simonsen, Jesper; K. Iversen, Rikke

    2006-01-01

    during a series of workshops with the clinicians after which the XML configuration files were written and deployed. In parallel with this, the participants from the University specified a number of effects related to the clinical practice to be measured. Measurements were focused on the requested effects...

  1. Case report: clinical and postmortem findings in four cows with rib fracture.

    Science.gov (United States)

    Braun, Ueli; Warislohner, Sonja; Hetzel, Udo; Nuss, Karl

    2017-02-06

    Published reports of rib fractures in adult cattle are limited to the occurrence of chronic rib swellings caused by calluses, which are unremarkable from a clinical standpoint, whereas studies identifying clinical signs of rib fractures were not found in a literature search. This report describes the clinical and postmortem findings in four cows with rib fractures. The 13th rib was fractured in three cows and the 11th rib in the remaining cow; three fractures were on the right and one on the left side. Clinical and postmortem findings varied considerably, and percussion of the rib cage elicited a pain response in only one cow. One cow had generalised peritonitis because of perforation of the rumen by the fractured rib. One cow was recumbent because of pain and became a downer cow, and two other cows had bronchopneumonia, which was a sequel to osteomyelitis of the fracture site in one. In the absence of a history of trauma, the diagnosis of rib fracture based on clinical signs alone is difficult. Although rib fractures undoubtedly are very painful, the four cases described in this report suggest that they are difficult to diagnose in cattle because associated clinical signs are nonspecific.

  2. [Electronic cigarettes - effects on health. Previous reports].

    Science.gov (United States)

    Napierała, Marta; Kulza, Maksymilian; Wachowiak, Anna; Jabłecka, Katarzyna; Florek, Ewa

    2014-01-01

    Currently very popular in the market of tobacco products have gained electronic cigarettes (ang. E-cigarettes). These products are considered to be potentially less harmful in compared to traditional tobacco products. However, current reports indicate that the statements of the producers regarding to the composition of the e- liquids not always are sufficient, and consumers often do not have reliable information on the quality of the product used by them. This paper contain a review of previous reports on the composition of e-cigarettes and their impact on health. Most of the observed health effects was related to symptoms of the respiratory tract, mouth, throat, neurological complications and sensory organs. Particularly hazardous effects of the e-cigarettes were: pneumonia, congestive heart failure, confusion, convulsions, hypotension, aspiration pneumonia, face second-degree burns, blindness, chest pain and rapid heartbeat. In the literature there is no information relating to passive exposure by the aerosols released during e-cigarette smoking. Furthermore, the information regarding to the use of these products in the long term are not also available.

  3. Patient-reported outcomes (PRO) in ovarian cancer clinical trials-lost opportunities and lessons learned.

    Science.gov (United States)

    Friedlander, M; Mercieca-Bebber, R L; King, M T

    2016-04-01

    Despite increased recognition of the value of including patient-reported outcomes (PROs) as important end points in phase III clinical trials, there has been a lack of pre-specified PRO hypotheses and shortcomings with the analyses and interpretation of PROs in many ovarian cancer trials. This paper discusses and provides examples of the so-called lost opportunities in ovarian cancer trials. These include: (i) no clear pre-specified PRO hypotheses; (ii) PRO end points not included; (iii) insensitive PRO end point selection; (iv) collection of poor-quality PRO data not suitable for analysis; (v) differences in PROs between treatment arms ignored; and (vi) poor reporting quality. We can learn from the past and with relatively little additional effort, improve the collection and interpretation of PRO data in future ovarian cancer trials. The importance of doing so is underpinned by recent initiatives to improve the standard and usefulness of PRO data in clinical trials. These include the Food and Drug Administration (FDA) Guidance for PROs to support labelling claims, the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO MCBS), the International Society for Quality-of-Life Research PRO reporting guidance and the Consolidated Standards of Reporting Clinical Trials (CONSORT)-PRO-extension statement which includes a checklist of recommended items to include in PRO sections of trial protocols. Promoting the importance of hypothesis-driven PROs in ovarian cancer clinical trials will lead to improvements in the design of these trials and the interpretation of their results.

  4. Effects of clinical practice focusing on level-3 OSCE items.

    Science.gov (United States)

    Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Wada, Yosuke; Yamada, Masayuki; Tomita, Masao; Tanabe, Shigeo; Koyama, Soichiro; Teranishi, Toshio; Sawa, Syunji; Okanishi, Tetsuo

    2015-05-01

    [Purpose] This study examined the effects of clinical training focusing on level-3 OSCE (analytical and therapeutic skills) items, and compared the achievement levels of physical (PT) and occupational (OT) therapist students. [Subjects] A total of 282 (165 PT and 117 OT) students enrolled at our university between 2008 and 2010 were studied. [Methods] OSCE scores were compared between before and after clinical training focusing on level-3 OSCE items, and between PT and OT students. [Results] Scores for 5 out of the 6 level-3a items were significantly higher after than before clinical training. Increases in scores of 2 or 3 level-3b and -3c items were also observed after clinical training. There were no marked differences between PT and OT students in scores for level-3a, -3b, and -3c items before clinical training. In contrast, after clinical training, OT students' scores for 3a and 3c items related to dressing were higher than those of PT students, and the latter's scores for 3b items related to transfer were higher than those of the former. [Conclusion] The results suggest level-3 OSCE items are effectively taught during clinical training.

  5. What do we know about pulmonary blastoma?: review of literature and clinical case report.

    Science.gov (United States)

    Brodowska-Kania, Dorota; Kotwica, Ewa; Paturej, Aleksandra; Sośnicki, Witold; Patera, Janusz; Giżewska, Agnieszka; Niemczyk, Stanisław

    2016-12-01

    Pulmonary blastoma (PB) is a rare form of lung tumour and is accountable for 0.25-0.5% of primary pulmonary malignancies. Initially pulmonary blastoma was divided into three subtypes: biphasic pulmonary blastoma (BPB) consisting of an epithelial and mesenchymal component, well differentiated fetal adenocarcinoma (WDFA) built of well differentiated epithelium and a mesenchymal component and malignant pleuropulmonary blastoma (PPB). Prognosis in this type of cancer is really poor. We present a current review of literature and a clinical case report. Treatment of PB is very difficult. Data and recommendations about the treatment of pulmonary blastoma are still available therefore we should use only observations and clinical case reports.

  6. Clinical Presentation of a Patient with Localized Acquired Cutis Laxa of Abdomen: A Case Report

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    Tugomir Gverić

    2010-01-01

    Objective. The aim of this case report was to present our patient suffering from CL, and to evaluate clinical presentation, diagnostic and therapeutic difficulties in this rare condition. Case Report. A 30-year-old female patient was admitted to our Hospital due to localized loose and sagging skin of abdomen, induced by prior cesarean section 6 years ago. CL has been diagnosed based on the clinical picture and pathohistological appearance. Conclusion. Reconstructive surgery provides a dramatic cosmetic improvement with significant psychosocial benefit. Repeated surgical procedures may be required to correct the lax skin, which worsens with age.

  7. A Deliberation for Evaluating Clinical Effects in Chinese Medicine

    Institute of Scientific and Technical Information of China (English)

    WANG Jia-liang

    2010-01-01

    @@ Chinese medicine (CM) has several thousands of years of history and has made a great contribution to human health and disease prevention in the world.Since there are so many differences between CM and Western medicine (WM) on their theory and methods in disease diagnosis and treatment,how to evaluate the clinical effects exactly and correctly in clinical practice becomes one bottleneck problem in CM.This is also the primary theme of the 369th Xiangshan Seminar,2010,Beijing.

  8. Clinical dilemma of acute abdomen in patients with systemic lupuserythematosus: A case report

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    Ali Ghavidel

    2017-06-01

    Full Text Available Introduction: Gastrointestinal (GI symptoms and signs may be seen in approximately one third ofpatients with rheumatologic disorders as primary presentation. Some of these findings may benondiagnostic and may be clinical diagnostic challenge. GI tract involvement by systemic lupuserythematosus (SLE must be differentiated from adverse drug reactions of treatment agents.Abdominal pain, associated with nausea and vomiting, is seen in up to 30 percent of patients withSLE. The cause of abdominal pain does not differ significantly from that in patients without lupus.Special attention should be given to conditions that may accompany lupus such as lupus peritonitisand infection. Lupus peritonitis is very unusual clinical finding and it is worth reporting.Case Report: Our patient was a young female with definite rheumatologic disorders with acuteabdomen as the dominant clinical finding. Imaging findings confirmed peritoneum and smallintestine involvement. Paraclinical work-up including blood analysis confirmed SLE. She wasmanaged with prednisone and non-steroidal anti-inflammatory agents, and discharged withpartial improvement.Conclusion: This case report shows that patients with symptoms consistent with acute abdomen inSLE remind us a clinical dilemma. There have been few reports of acute abdomen in patients withSLE in the literature. And more case reports are needed.

  9. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

    Science.gov (United States)

    Khan, Safdar N; Mermer, Matthew J; Myers, Elizabeth; Sandhu, Harvinder S

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (PJournal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  10. Concordance between patient self-reports and claims data on clinical diagnoses, medication use, and health system utilization in Taiwan.

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    Chi-Shin Wu

    Full Text Available PURPOSE: The aim of this study was to evaluate the concordance between claims records in the National Health Insurance Research Database and patient self-reports on clinical diagnoses, medication use, and health system utilization. METHODS: In this study, we used the data of 15,574 participants collected from the 2005 Taiwan National Health Interview Survey. We assessed positive agreement, negative agreement, and Cohen's kappa statistics to examine the concordance between claims records and patient self-reports. RESULTS: Kappa values were 0.43, 0.64, and 0.61 for clinical diagnoses, medication use, and health system utilization, respectively. Using a strict algorithm to identify the clinical diagnoses recorded in claims records could improve the negative agreement; however, the effect on positive agreement and kappa was diverse across various conditions. CONCLUSION: We found that the overall concordance between claims records in the National Health Insurance Research Database and patient self-reports in the Taiwan National Health Interview Survey was moderate for clinical diagnosis and substantial for both medication use and health system utilization.

  11. Do team processes really have an effect on clinical performance? A systematic literature review.

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    Schmutz, J; Manser, T

    2013-04-01

    There is a growing literature on the relationship between team processes and clinical performance. The purpose of this review is to summarize these articles and examine the impact of team process behaviours on clinical performance. We conducted a literature search in five major databases. Inclusion criteria were: English peer-reviewed papers published between January 2001 and May 2012, which showed or tried to show (i) a statistical relationship of a team process variable and clinical performance or (ii) an improvement of a performance variable through a team process intervention. Study quality was assessed using predefined quality indicators. For every study, we calculated the relevant effect sizes. We included 28 studies in the review, seven of which were intervention studies. Every study reported at least one significant relationship between team processes or an intervention and performance. Also, some non-significant effects were reported. Most of the reported effect sizes were large or medium. The study quality ranged from medium to high. The studies are highly diverse regarding the specific team process behaviours investigated and also regarding the methods used. However, they suggest that team process behaviours do influence clinical performance and that training results in increased performance. Future research should rely on existing theoretical frameworks, valid, and reliable methods to assess processes such as teamwork or coordination and focus on the development of adequate tools to assess process performance, linking them with outcomes in the clinical setting.

  12. Nursing students' perspectives on clinical instructors' effective teaching strategies: A descriptive study.

    Science.gov (United States)

    Valiee, Sina; Moridi, Glorokh; Khaledi, Shahnaz; Garibi, Fardin

    2016-01-01

    An important factor contributing to the quality of clinical education is instructors' teaching performance. The aim of this study was to identify clinical instructors' most effective teaching strategies from nursing and midwifery students' perspectives. This was a descriptive cross-sectional study. All third- and fourth-year bachelor's nursing and midwifery students studying at the Nursing and Midwifery Faculty of Kurdistan University of Medical Sciences were recruited to the study by using the census method. The study instrument consisted of a demographic questionnaire and the self-report 30-item Clinical Instructors' Effective Teaching Strategies Inventory. The SPSS v.16.0 was used for data analysis. The most effective teaching strategies of clinical instructors from nursing and midwifery students' perspectives were respectively 'treating students, clients, and colleagues with respect' and 'being eager for guiding students and manage their problems'. Clinical instructors need to be eager for education and also be able to establish effective communication with students. Empowering clinical instructors in specialized and technical aspects of clinical education seems necessary.

  13. Adjunctive naturopathic care for type 2 diabetes: patient-reported and clinical outcomes after one year

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    Bradley Ryan

    2012-04-01

    Full Text Available Abstract Background Several small, uncontrolled studies have found improvements in self-care behaviors and reductions in clinical risk in persons with type 2 diabetes who received care from licensed naturopathic physicians. To extend these findings and determine the feasibility and promise of a randomized clinical trial, we conducted a prospective study to measure the effects of adjunctive naturopathic care (ANC in primary care patients with inadequately controlled type 2 diabetes. Methods Forty patients with type 2 diabetes were invited from a large integrated health care system to receive up to eight ANC visits for up to one year. Participants were required to have hemoglobin A1c (HbA1c values between 7.5-9.5 % and at least one additional cardiovascular risk factor (i.e., hypertension, hyperlipidemia or overweight. Standardized instruments were administered by telephone to collect outcome data on self-care, self-efficacy, diabetes problem areas, perceived stress, motivation, and mood. Changes from baseline scores were calculated at 6- and 12-months after entry into the study. Six and 12-month changes in clinical risk factors (i.e., HbA1c, lipid and blood pressure were calculated for the ANC cohort, and compared to changes in a cohort of 329 eligible, non-participating patients constructed using electronic medical records data. Between-cohort comparisons were adjusted for age, gender, baseline HbA1c, and diabetes medications. Six months was pre-specified as the primary endpoint for outcome assessment. Results Participants made 3.9 ANC visits on average during the year, 78 % of which occurred within six months of entry into the study. At 6-months, significant improvements were found in most patient-reported measures, including glucose testing (P = 0.001, diet (P = 0.001, physical activity (P = 0.02, mood (P = 0.001, self-efficacy (P = 0.0001 and motivation to change lifestyle (P = 0.003. Improvements in glucose testing, mood, self-efficacy and

  14. A preliminary study of the effect of eliminating requirements on clinical performance.

    Science.gov (United States)

    Dodge, W W; Dale, R A; Hendricson, W D

    1993-09-01

    This study determined the effect of a clinical program driven by patient needs upon students' productivity, attitudes, and academic performance. A group of eight senior students, whose academic and clinical performance profile replicated that of the rest of the class, were chosen to participate in a year-long non-requirement clinic. The students were expected to attend all clinic sessions, and treat their assigned patients. Their performance was compared to that of classmates in the regular requirement-driven curriculum. The non-requirement group had significantly higher academic achievement and significantly outproduced their classmates. Non-requirement students had no state board failures, versus 17 percent in the regular curriculum, and reported significantly lower stress. This study suggests that predoctoral clinical programs can maintain quality and productivity in the absence of unit requirements.

  15. Safety reporting in developing country vaccine clinical trials-a systematic review.

    Science.gov (United States)

    Muehlhans, Susann; Richard, Georgina; Ali, Mohammad; Codarini, Gabriela; Elemuwa, Chris; Khamesipour, Ali; Maurer, Wolfgang; Mworozi, Edison; Kochhar, Sonali; Rundblad, Gabriella; Vuitton, Dominique; Rath, Barbara

    2012-05-09

    With more vaccines becoming available worldwide, vaccine research is on the rise in developing countries. To gain a better understanding of safety reporting from vaccine clinical research in developing countries, we conducted a systematic review in Medline and Embase (1989-2011) of published randomized clinical trials (RCTs) reporting safety outcomes with ≥50% developing country participation (PROSPERO systematic review registration number: CRD42012002025). Developing country vaccine RCTs were analyzed with respect to the number of participants, age groups studied, inclusion of safety information, number of reported adverse events following immunization (AEFI), type and duration of safety follow-up, use of standardized AEFI case definitions, grading of AEFI severity, and the reporting of levels of diagnostic certainty for AEFI. The systematic search yielded a total number of 50 randomized vaccine clinical trials investigating 12 different vaccines, most commonly rotavirus and malaria vaccines. In these trials, 94,459 AEFI were reported from 446,908 participants receiving 735,920 vaccine doses. All 50 RCTs mentioned safety outcomes with 70% using definitions for at least one AEFI. The most commonly defined AEFI was fever (27), followed by local (16) and systemic reactions (14). Logistic regression analysis revealed a positive correlation between the implementation of a fever case definition and the reporting rate for fever as an AEFI (p=0.027). Overall, 16 different definitions for fever and 7 different definitions for erythema were applied. Predefined AEFI case definitions by the Brighton Collaboration were used in only two out of 50 RCTs. The search was limited to RCTs published in English or German and may be missing studies published locally. The reported systematic review suggests room for improvement with respect to the harmonization of safety reporting from developing country vaccine clinical trials and the implementation of standardized case definitions.

  16. Validity and reliability of patient reported outcomes used in Psoriasis: results from two randomized clinical trials

    OpenAIRE

    Koo John; Thompson Christine; Stone Stephen P; Bresnahan Brian W; Shikiar Richard; Revicki Dennis A

    2003-01-01

    Abstract Background Two Phase III randomized controlled clinical trials were conducted to assess the efficacy, safety, and tolerability of weekly subcutaneous administration of efalizumab for the treatment of psoriasis. Patient reported measures of psoriasis-related functionality and health-related quality of life and of psoriasis-related symptom assessments were included as part of the trials. Objective To assess the reliability, validity, and responsiveness of the patient reported outcome m...

  17. Missing Clinical Information in NHS hospital outpatient clinics: prevalence, causes and effects on patient care

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    Moorthy Krishna

    2011-05-01

    Full Text Available Abstract Background In Britain over 39,000 reports were received by the National Patient Safety Agency relating to failures in documentation in 2007 and the UK Health Services Journal estimated in 2008 that over a million hospital outpatient visits each year might take place without the full record available. Despite these high numbers, the impact of missing clinical information has not been investigated for hospital outpatients in the UK. Studies in primary care in the USA have found 13.6% of patient consultations have missing clinical information, with this adversely affecting care in about half of cases, and in Australia 1.8% of medical errors were found to be due to the unavailability of clinical information. Our objectives were to assess the frequency, nature and potential impact on patient care of missing clinical information in NHS hospital outpatients and to assess the principal causes. This is the first study to present such figures for the UK and the first to look at how clinicians respond, including the associated impact on patient care. Methods Prospective descriptive study of missing information reported by surgeons, supplemented by interviews on the causes. Data were collected by surgeons in general, gastrointestinal, colorectal and vascular surgical clinics in three teaching hospitals across the UK for over a thousand outpatient appointments. Fifteen interviews were conducted with those involved in collating clinical information for these clinics. The study had ethics approval (Hammersmith and Queen Charlotte's & Chelsea Research Ethics Committee, reference number (09/H0707/27. Participants involved in the interviews signed a consent form and were offered the opportunity to review and agree the transcript of their interview before analysis. No patients were involved in this research. Results In 15% of outpatient consultations key items of clinical information were missing. Of these patients, 32% experienced a delay or disruption

  18. The reliability of manual reporting of clinical events in an anesthesia information management system (AIMS).

    Science.gov (United States)

    Simpao, Allan F; Pruitt, Eric Y; Cook-Sather, Scott D; Gurnaney, Harshad G; Rehman, Mohamed A

    2012-12-01

    Manual incident reports significantly under-report adverse clinical events when compared with automated recordings of intraoperative data. Our goal was to determine the reliability of AIMS and CQI reports of adverse clinical events that had been witnessed and recorded by research assistants. The AIMS and CQI records of 995 patients aged 2-12 years were analyzed to determine if anesthesia providers had properly documented the emesis events that were observed and recorded by research assistants who were present in the operating room at the time of induction. Research assistants recorded eight cases of emesis during induction that were confirmed with the attending anesthesiologist at the time of induction. AIMS yielded a sensitivity of 38 % (95 % confidence interval [CI] 8.5-75.5 %), while the sensitivity of CQI reporting was 13 % (95 % CI 0.3-52.7 %). The low sensitivities of the AIMS and CQI reports suggest that user-reported AIMS and CQI data do not reliably include significant clinical events.

  19. Biased safety reporting in blinded randomized clinical trials: meta-analysis of angiotensin receptor blocker trials.

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    Nobuyoshi Takabayashi

    Full Text Available BACKGROUND: Cough is listed as an adverse drug reaction (ADR on the labels of angiotensin receptor blockers (ARB. However, a causal association with cough has also been reported for angiotensin converting enzyme inhibitors (ACEI, which have frequently been used as comparator drugs in the registration clinical trials of ARBs. This prompted us to examine the possible influence of using comparator drugs with well-known ADRs on the safety reporting of investigational drugs in blinded randomized clinical trials. METHODS AND FINDINGS: The double-blinded, randomized clinical trials with comparator drugs were identified in the Japanese dossiers for the new drug applications of ARBs. The risk ratios (RR of reporting cough and headache in ARB arms were calculated for each ARB by comparing trials using ACEIs and trials using non-ACEIs, were then combined with a meta-analysis. 23 trials with a total of 6643 patients were identified, consisting 6 trials using an ACEI comparator including 819 ARB patients and 17 trials using a non-ACEI comparator including 5824 ARB patients. The combined RR of cough reporting was significantly elevated (20.77; 95% confidence interval [CI], 7.47 to 57.76, indicating more frequent reporting of cough in clinical trials using an ACEI comparator. In contrast, the combined RR of headache, a negative control, was insignificant (1.45; 95% CI, 0.34 to 6.22. CONCLUSION: The use of comparators with well-known ADRs in blinded randomized trials produces potential bias in the reporting frequency of ADRs for investigational drugs. The selection of appropriate comparator drugs should be critical in unbiased safety assessment in double-blinded, randomized clinical trials and thus have relevance in reviewing the safety results from a regulatory point of view.

  20. Clinical cancer advances 2011: Annual Report on Progress Against Cancer from the American Society of Clinical Oncology.

    Science.gov (United States)

    Vogelzang, Nicholas J; Benowitz, Steven I; Adams, Sylvia; Aghajanian, Carol; Chang, Susan Marina; Dreyer, Zoann Eckert; Janne, Pasi A; Ko, Andrew H; Masters, Greg A; Odenike, Olatoyosi; Patel, Jyoti D; Roth, Bruce J; Samlowski, Wolfram E; Seidman, Andrew D; Tap, William D; Temel, Jennifer S; Von Roenn, Jamie H; Kris, Mark G

    2012-01-01

    -time information that can inform the care of every patient with cancer as well as connect patients with their entire medical teams. The rapid learning system will form a continuous cycle of learning: securely capturing data from every patient at the point of care, drawing on evidence-based guidelines, and evaluating quality of care against those standards and the outcomes of other patients. Clinical trials are another area in which collaboration is critical. Increasing clinical trial participation will require commitment across the cancer community from physicians, patients, insurers, hospitals, and industry. A 2010 report by the Institute of Medicine described challenges to participation in trials by both physicians and patients and provided recommendations for revitalizing clinical trials conducted through the National Cancer Institute's Cooperative Group Program. ASCO has pledged its support for the full implementation of these recommendations. More broadly, ASCO recently outlined a bold vision for translational and clinical cancer research for the next decade and made recommendations to achieve that vision. Accelerating Progress Against Cancer: ASCO's Blueprint for Transforming Clinical and Translational Research, released in November, calls for a research system that takes full advantage of today's scientific and technologic opportunities and sets a high-level agenda for policy makers, regulators, and advocates. Cancer research has transformed cancer care in the past forty years, and this year's Clinical Cancer Advances illustrates how far we have come in the past year alone. We now have a tremendous opportunity to use today's knowledge and collaborate across all facets of cancer care to conquer this deadly disease. Michael P. Link, MD President American Society of Clinical Oncology.

  1. Why mistreatment of medical students is not reported in clinical settings: perspectives of trainees.

    Science.gov (United States)

    Ahmadipour, Habibeh; Vafadar, Reza

    2016-01-01

    Mistreatment of medical students is a major source of stress for them. Studies indicate a high incidence of such mistreatment, especially in clinical settings. In most cases, students who have been mistreated do not report it to the authorities. This study investigated factors related to the failure to report mistreatment. This was a cross-sectional study carried out in Kerman Medical School, Iran. All students in the internship and clerkship stages, as well as residents, were selected through the census method. Experiences of mistreatment and the reasons for not reporting them were evaluated using a questionnaire. The data were analysed with SPSS 19. Ninety-three per cent of the participants experienced mistreatment, but less than half of them reported it. Residents and interns reported emotional and academic mistreatment, respectively, more than other groups. The most common reason for not reporting mistreatment was that the students did not think reporting would accomplish anything. Our study showed that the experience of mistreatment in the clinical setting is common, but the cases reported to the authorities are far fewer than the actual number of cases. Educational systems should make extensive efforts to detect and prevent mistreatment to improve the teaching-learning environment.

  2. Reported Sildenafil Side Effects in Pediatric Pulmonary Hypertension Patients

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    Stephanie Leigh Siehr

    2015-03-01

    Full Text Available Background: Sildenafil, a phosphodiestase type 5 inhibitor, was approved in 2005 for the treatment of pulmonary arterial hypertension (PAH in adults, and is commonly used off-label for pediatric patients. Little is known, however, about sildenafil’s side effects in this population.Methods: Single institution, longitudinal survey-based study performed in an outpatient pediatric cardiology clinic. Pediatric patients on sildenafil (alone or in combination with other PH therapies completed questionnaires regarding frequency of vascular, gastrointestinal, neurologic and hematologic side effects. Results: Between January 2011 and May 2014, 66 pediatric patients with PH on sildenafil filled out 214 surveys, 32 patients (96 surveys on monotherapy, and 43 patients (118 surveys on sildenafil plus an endothelin receptor antagonist (bosentan or ambrisentan and/or a prostacyclin (epoprostenol or treprostinil. Overall, 30% of respondents identified at least one side effect. For all patients on sildenafil, incidence of side effects by system was 37% gastrointestinal, 35% vascular and 22% neurologic. For patients on sildenafil monotherapy, incidence of side effects by system was 24% gastrointestinal, 21% vascular and 18% neurologic compared to patients on combination therapy who reported an incidence of 48% gastrointestinal, 45% vascular and 25% neurologic.Conclusion: Incidence of vascular, gastrointestinal and neurologic side effect in pediatric patients on sildenafil therapy for pulmonary arterial hypertension was 30%. Side effects were more common in patients on combination therapy with an endothelin receptor antagonist and/or prostacyclin than in patients on sildenafil monotherapy.

  3. What are the effective ways to translate clinical leadership into health care quality improvement?

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    McSherry R

    2016-02-01

    Full Text Available Robert McSherry,1 Paddy Pearce2 1School of Health and Social Care, University of Teesside, Middlesbrough, 2PKP Consulting, Yarm, United Kingdom Abstract: The presence and/or absence of effective leaders in health care can have a stark consequence on the quality and outcomes of care. The delivery of safe, quality, compassionate health care is dependent on having effective clinical leaders at the frontline. In light of the Kirkup and Francis reports, this article explores some ways of translating clinical leadership into health care quality improvement. This is achieved by exploring what is clinical leadership and why and how this is important to health care quality improvement, clinical leadership, and a duty of candor, along with the importance clinical leadership plays in the provision of quality care improvement and outcomes. Clinical leaders are not predefined roles but emerge from the complex clinical setting by gaining an acquired expertise and from how they then internalize this to develop and facilitate sound relationships within a team. Clinical leaders are effective in facilitating innovation and change through improvement. This is achieved by recognizing, influencing, and empowering individuals through effective communication in order to share and learn from and with each other in practice. The challenge for health care organizations in regard to creating organizational cultures where a duty of candor exists is not to reinvent the wheel by turning something that is simple into something complex, which can become confusing to health care workers, patients, and the public. By focusing on the clinical leader's role and responsibilities we would argue they play a crucial and pivotal role in influencing, facilitating, supporting, and monitoring that this duty of candor happens in practice. This may be possible by highlighting where and how the duty of candor can be aligned within existing clinical governance frameworks. Keywords: governance

  4. Effectiveness of manual therapies: the UK evidence report

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    Leininger Brent

    2010-02-01

    Full Text Available Abstract Background The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. Methods The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs, widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. Results By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines. Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. Conclusions Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and

  5. Effectiveness of manual therapies: the UK evidence report.

    Science.gov (United States)

    Bronfort, Gert; Haas, Mitch; Evans, Roni; Leininger, Brent; Triano, Jay

    2010-02-25

    The purpose of this report is to provide a succinct but comprehensive summary of the scientific evidence regarding the effectiveness of manual treatment for the management of a variety of musculoskeletal and non-musculoskeletal conditions. The conclusions are based on the results of systematic reviews of randomized clinical trials (RCTs), widely accepted and primarily UK and United States evidence-based clinical guidelines, plus the results of all RCTs not yet included in the first three categories. The strength/quality of the evidence regarding effectiveness was based on an adapted version of the grading system developed by the US Preventive Services Task Force and a study risk of bias assessment tool for the recent RCTs. By September 2009, 26 categories of conditions were located containing RCT evidence for the use of manual therapy: 13 musculoskeletal conditions, four types of chronic headache and nine non-musculoskeletal conditions. We identified 49 recent relevant systematic reviews and 16 evidence-based clinical guidelines plus an additional 46 RCTs not yet included in systematic reviews and guidelines.Additionally, brief references are made to other effective non-pharmacological, non-invasive physical treatments. Spinal manipulation/mobilization is effective in adults for: acute, subacute, and chronic low back pain; migraine and cervicogenic headache; cervicogenic dizziness; manipulation/mobilization is effective for several extremity joint conditions; and thoracic manipulation/mobilization is effective for acute/subacute neck pain. The evidence is inconclusive for cervical manipulation/mobilization alone for neck pain of any duration, and for manipulation/mobilization for mid back pain, sciatica, tension-type headache, coccydynia, temporomandibular joint disorders, fibromyalgia, premenstrual syndrome, and pneumonia in older adults. Spinal manipulation is not effective for asthma and dysmenorrhea when compared to sham manipulation, or for Stage 1

  6. Posterior open occlusion management by registration of overlay removable partial denture: A clinical report

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    Saeid Nosouhian

    2015-01-01

    Full Text Available This clinical report describes prosthetic rehabilitation of posterior open bite relationship in a patient with several missing teeth and skeletal Class III malocclusion. Primary diagnostic esthetic evaluations were performed by mounting casts in centric relation and estimating lost vertical dimension of occlusion. Exclusive treatments were designated by applying overlay removable partial denture with external attachment systems for higher retentions.

  7. Posterior open occlusion management by registration of overlay removable partial denture: A clinical report.

    Science.gov (United States)

    Nosouhian, Saeid; Davoudi, Amin; Derhami, Mohammad

    2015-01-01

    This clinical report describes prosthetic rehabilitation of posterior open bite relationship in a patient with several missing teeth and skeletal Class III malocclusion. Primary diagnostic esthetic evaluations were performed by mounting casts in centric relation and estimating lost vertical dimension of occlusion. Exclusive treatments were designated by applying overlay removable partial denture with external attachment systems for higher retentions.

  8. Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

    NARCIS (Netherlands)

    Kampen, D.A. van

    2013-01-01

    In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable

  9. Combining Clinical Information and Patient Reported Outcome Measures in Orthopaedic Surgery and Sports Medicine

    NARCIS (Netherlands)

    Kampen, D.A. van

    2013-01-01

    In this thesis we investigated the use of clinical information and Patient Reported Outcome Measures (PROMs) for patient evaluation in orthopaedic surgery and sports medicine. In the first part, we showed that the Dutch version of the Simple Shoulder Test (SST) is a valid and reliable instrumen

  10. Replacing worn overdenture abutments of an unknown implant system by using laser welding: a clinical report.

    Science.gov (United States)

    Mohunta, Vrinda V; Stevenson, James A; Lee, Damian J

    2014-09-01

    This clinical report describes a procedure for replacing worn ball abutments with low-profile resilient abutments by using laser welding when the implant system for a mandibular implant-supported overdenture could not be identified. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  11. Clinical research on peri-implant diseases: consensus report of Working Group 4.

    LENUS (Irish Health Repository)

    Sanz, Mariano

    2012-02-01

    Two systematic reviews have evaluated the quality of research and reporting of observational studies investigating the prevalence of, the incidence of and the risk factors for peri-implant diseases and of experimental clinical studies evaluating the efficacy of preventive and therapeutic interventions.

  12. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    NARCIS (Netherlands)

    Aletaha, D.; Landewe, R.B.; Karonitsch, T.; Bathon, J.; Boers, M.; Bombardier, C.; Bombardieri, S.; Choi, H.; Combe, B.; Dougados, M.; Emery, P.; Gomez-Reino, J.; Keystone, E.C.; Koch, G.; Kvien, T.K.; Martin-Mola, E.; Matucci-Cerinic, M.; Michaud, K.; O'Dell, J.; Paulus, H.; Pincus, T.; Richards, P.; Simon, L.; Siegel, J.; Smolen, J.S.; Sokka, T.; Strand, V.; Tugwell, P.; Heijde, D. van der; Riel, P.L.C.M. van; Vlad, S.; Vollenhoven, R. van; Ward, M.; Weinblatt, M.; Wells, G.A.; White, B.; Wolfe, F.; Zhang, B.; Zink, A.; Felson, D.T.

    2008-01-01

    OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardized operating procedures, w

  13. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    NARCIS (Netherlands)

    Aletaha, D.; Landewe, R.B.; Karonitsch, T.; Bathon, J.; Boers, M.; Bombardier, C.; Bombardieri, S.; Choi, H.; Combe, B.; Dougados, M.; Emery, P.; Gomez-Reino, J.; Keystone, E.C.; Koch, G.; Kvien, T.K.; Martin-Mola, E.; Matucci-Cerinic, M.; Michaud, K.; O'Dell, J.; Paulus, H.; Pincus, T.; Richards, P.; Simon, L.; Siegel, J.; Smolen, J.S.; Sokka, T.; Strand, V.; Tugwell, P.; Heijde, D. van der; Riel, P.L.C.M. van; Vlad, S.; Vollenhoven, R. van; Ward, M.; Weinblatt, M.; Wells, G.A.; White, B.; Wolfe, F.; Zhang, B.; Zink, A.; Felson, D.T.

    2008-01-01

    OBJECTIVE: To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). METHODS: The project followed the EULAR standardised operating procedures, w

  14. The risk of unblinding was infrequently and incompletely reported in 300 randomized clinical trial publications

    DEFF Research Database (Denmark)

    Bello, Segun; Moustgaard, Helene; Hróbjartsson, Asbjørn

    2014-01-01

    for unblinding was perceptible physical properties of the treatments, for example, a difference in the taste and odor of a typhoid vaccine compared with its placebo. CONCLUSION: Published articles on randomized clinical trials infrequently reported risk of unblinding. This may reflect a tendency for avoiding...

  15. Frenectomy with anterior lingual sulcoplasty for an implant-supported overdenture: A clinical report.

    Science.gov (United States)

    Perri de Carvalho, Paulo Sergio; Janjacomo, Luiz Antonio; Ponzoni, Daniela

    2016-04-01

    This clinical report describes the deepening of a patient's anterior mandibular lingual sulcus in combination with frenectomy and the use of an acrylic resin guiding device fixed to an osseointegrated dental implant to maintain the patency of the new sulcular depth.

  16. Prosthetic and Surgical Approach for Oral Rehabilitation in a Patient with Amelogenesis Imperfecta: A Clinical Report

    Directory of Open Access Journals (Sweden)

    H. Sazegara

    2007-06-01

    Full Text Available Amelogenesis imperfecta is a heterogeneous group of hereditary disorders. Its treatment continues throughout the patients’ childhood and adolescence and consists of advanced restorative care in severe cases.A thorough prosthodontic treatment plan including orthognatic surgery, full veneer crowns and all ceramic anterior crowns is presented in this clinical report.

  17. Clinical aspects of type 1 posterior laryngeal clefts: literature review and a report of 31 patients.

    NARCIS (Netherlands)

    Doef, H.P. van der; Yntema, J.L.; Hoogen, F.J.A. van den; Marres, H.A.M.

    2007-01-01

    OBJECTIVES: The clinical relevance of posterior laryngeal clefts (PLCs) of type 1 has only recently been highlighted in the medical literature. We present a review of the literature and a report of a contributive series of 31 type 1 PLC patients. STUDY DESIGN AND METHODS: We performed a MEDLINE

  18. Effects of dry period length on clinical mastitis and other major clinical health disorders

    DEFF Research Database (Denmark)

    Enevoldsen, Carsten; Sørensen, J.T.

    1992-01-01

    Four, 7-, and 10-wk dry periods were randomly assigned to 366 dairy cows in eight herds. A multiple polytomous logistic regression analysis was conducted with the objective to reveal possible important effects of the dry period on the risk of contracting major clinical health disorders. Several...... calving intervals, the risk of occurrence of complications at calving decreased with the length of the dry period. This relation was reversed at longer calving intervals. Dry period lengths of approximately 7 wk appear to be associated with the lowest risk of clinical health disorders, but other factors...

  19. [Clinical effectiveness of nadroparin calcium in the surgical treatment of breast cancer].

    Science.gov (United States)

    Iaremchuk, A Ia; Zotov, A S; Cheshuk, V E; Anikuc'ko, N F; Zakhartseva, L M; Diatel, M V; Kravchenko, A V; Lobanova, O E; Sidorchuk, O I

    2003-01-01

    The report deals with an assessment of frequency of fatal thromboembolic complications after surgery for breast cancer, in particular, frequency and severity of the side-effects of calcium nadroparin treatment as a component of surgical preparation. Considering the low incidence of thromboembolic complications in such patients and the side-effects of anti-coagulant therapy, it is suggested that decisions be made on a strictly individual basis under stringent clinical control.

  20. Wilson's disease: A Clinical autopsy case report with review of literature.

    Science.gov (United States)

    Raju, Kalyani; Bangalore, Gayathri Nagaraj; Thuruvekere, Suresh Nagaraj; Pathavanalli, Venkatarathnamma Narayanappa

    2015-01-01

    Wilson's disease is an autosomal recessive disease resulting in defective copper metabolism, which is usually seen in young adults, predominantly affecting liver and brain. Although it is not uncommon in India, variation in epidemiology, clinical presentation and course are reported. However, community-based incidence and prevalence rates are not available in India and incidences are limited to hospital based reports. Most often, the diagnosis is delayed. We present a clinical autopsy case in a 39 year-old female who had presented with clinical symptoms at 18 years of age. The duration of illness was 21 years. Patient's parent had consanguineous marriage and the younger sibling had died at 5 years of age with similar complaints.

  1. [Down syndrome associated with clinical manifestations of Kabuki syndrome: report of a case

    Science.gov (United States)

    Silva, E O; Freitas, E M; Costa, S M; Duarte, A R

    1999-01-01

    OBJECTIVE: To describe an atypical case of Down syndrome presenting with additional clinical manifestations that might be components of Kabuki (Niikawa-Kuroki) syndrome.CLINICAL REPORT: We report the clinical history of a 19-month-old girl with a 47,XX, +21 karyotype, who presented brachycephaly, flat face, long palpebral fissures, eversion of the lateral portion of the lower eyelids, arched eyebrows with sparse lateral regions, long eyelashes, epicanthus, cortical cataract, small ears, protruding tongue, muscular hypotonia, developmental delay, hyperflexibility of joints, brachydactyly, and dermatoglyphic abnormalities.CONCLUSION: The diagnosis of Down syndrome was confirmed cytogenetically. However, the presence of additional anomalies - mainly in the ocular region - suggested that the child might also have the Kabuki syndrome.

  2. Clinical Effects of Subgingivally Delivered Spirulina Gel in Chronic Periodontitis Cases: A Placebo Controlled Clinical Trial

    Science.gov (United States)

    Mahendra, Jaideep; Mahendra, Little; Muthu, Jananni; John, Libby; Romanos, Georgios E.

    2013-01-01

    Aims and Objectives: The aim of this study was to assess the clinical effects of Spirulina in-situ gel as an adjunct to Scaling And Root Planning (SRP) in the treatment of chronic periodontitis subjects. Material and Methods: 64 sites were selected with probing pocket depth of ≥5mm and they were divided into 2 groups; 33 sites were treated with SRP along with spirulina gel (Group A) and 31 sites were treated with SRP alone (Group B). Clinical parameters were recorded at baseline before SRP and at 120th day after the treatment therapy. The parameters included Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL). Results: Both the groups showed significant improvement in the parameters. However, Group A (SRP along with spirulina) showed statistically significant decrease in mean probing pocket depth and gain in the clinical attachment level after 120 days as compared to Group B SRP alone. Conclusion: Locally delivered spirulina gel, along with scaling and root planning, has been shown to cause a beneficial impact. The efficacy of the product as a local drug delivery system in the non-surgical treatment of periodontitis without any side effects has been proved. Spirulina appears to be promising. It exerts strong anti-inflammatory effects which are closely connected with its antioxidative activity. This study can have a significant impact on the treatment procedures of periodontitis, with the use of blue green algae in the future. PMID:24298522

  3. Confounding Effect in Clinical Research of Otolaryngology and Its Control.

    Science.gov (United States)

    Yu, Yong-qiang; Huang, Dong-yan; Armijo Olivo, Susan; Yang, Huai-an; Bambanini, Yagesh; Sonnenberg, Lyn; Clark, Brenda; Constantinescu, Gabriela; Qian Yu, Jason; Zhang, Ming

    2015-06-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research's conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research's design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research's design in which appropriate methods have been applied to prevent this effect.They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  4. Confounding Effect in Clinical Research of Otolaryngology and Its Control

    Institute of Scientific and Technical Information of China (English)

    Yong-qiang Yu; Ming Zhang; Dong-yan Huang; Susan Armijo Olivo; Huai-an Yang; Yagesh Bambanini; Lyn Sonnenberg; renda Clark; Gabriela Constantinescu; Jason Qian Yu

    2015-01-01

    Confounding effect is a critical issue in clinical research of otolaryngology because it can distort the research’s conclusion. In this review, we introduce the definition of confounding effect, the methods of verifying and controlling the effect. Confounding effect can be prevented by research’s design, and adjusted by data analysis. Clinicians would be aware and cautious about confounding effect in their research. They would be able to set up a research’s design in which appropriate methods have been applied to prevent this effect. They would know how to adjust confounding effect after data collection. It is important to remember that sometimes it is impossible to eliminate confounding effect completely, and statistical method is not a master key. Solid research knowledge and critical thinking of our brain are the most important in controlling confounding effect.

  5. Surgical extrusion technique for clinical crown lengthening: report of three cases.

    Science.gov (United States)

    Kim, Chang-Sung; Choi, Seong-Ho; Chai, Jung-Kiu; Kim, Chong-Kwan; Cho, Kyoo-Sung

    2004-10-01

    Although a number of techniques have been proposed for clinical crown lengthening procedures, all have some limitation in terms of function and esthetics. This report presents the clinical and radiographic results of a surgical extrusion technique for clinical crown lengthening. Atraumatic surgical extrusion using a specially designed instrument (Periotome) was performed in three cases in which it was expected that extensive resective osseous surgery would have to be used for crown lengthening. Full-thickness mucoperiosteal flaps were raised both labially and palatally. The tooth was carefully luxated and extruded to the desired position without damaging the marginal bone area or root apex. No rigid splint was applied. Clinical examinations performed for more than 1 year after surgery revealed probing depths crown lengthening; it does not induce functional or esthetic deformities, especially in the anterior region.

  6. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian

    2014-01-01

    Introduction In situ simulation offers a novel approach to training in the healthcare setting. It models clinical processes in a real clinical environment and provides the opportunity to correct errors and adjust team interactions without endangering patients. Training in the simulation laboratory...... does not tap into situational resources, e.g. individual, team, and organisational characteristics such as routines, personal relations, distributed skill-levels etc. Therefore, it fails to fully mimic real clinical team processes. Alternatively, in situ simulation offers a unique opportunity...... to explore and improve team processes in the clinical environment. Though research on in situ simulation in healthcare is in its infancy, literature is abundant on patient safety, medical simulation, team training and human factors1. Patient safety reporting systems that identify risks to patients can...

  7. De Garengeot's hernia in an 82-year-old man: a case report and clinical significance.

    Science.gov (United States)

    Leite, Túlio F; Chagas, Carlos A A; Pires, Lucas A S; Cisne, Rafael; Babinski, Márcio A

    2016-07-05

    The presence of the appendix within a femoral hernia (FH) sac is known as Garengeot's hernia (GH). We report on current study a rare case of an elderly man with a combined inguinal and Garengeot's hernia and discuss the clinical aspects. An 82-year-old man clinically stable, presented history of pain at the right inguinal region for over a week, without vomit, nausea, fever or any alteration of intestinal or urinary eliminations. Clinical examination revealed a FH and the ultrasonography confirmed the hernia sac. During the surgery, the appendix was recognized within the sac, and then, the patient underwent appendectomy and hernia repair. In conclusion, the presence of the vermiform appendix in a FH sac is rare, thus, requiring knowledge of the surgeon regarding this clinical entity. Prompt diagnosis and appropriate surgical treatment is the key to avoid complications.

  8. Clinical management of the first ASCUS report in Chile. Prospective single-cohort study

    Directory of Open Access Journals (Sweden)

    Fanny López-Alegría

    Full Text Available ABSTRACT CONTEXT AND OBJECTIVE: Worldwide, there is no single strategy for optimal management of patients with ASCUS (atypical squamous cells of undetermined significance cytology reports. The objective of this study was to determine the kind of clinical management conducted among women with a first ASCUS Pap smear report. DESIGN AND SETTING: Prospective single cohort study at a cervical pathology unit in Santiago, Chile. METHODS: This was an epidemiological, descriptive, observational and quantitative follow-up study on a cohort of women with ASCUS cytological reports. RESULTS: In the screening phase, 92,001 cervical cytological smears were collected in primary healthcare clinics. In the diagnostic phase, all women with a first ASCUS report were selected (n = 446. These women were asked to undergo the Pap test again and it was found that 301 women had normal results, 62 women had abnormal results and 83 did not repeat the test. In the diagnostic confirmation phase, the 62 women with abnormal results underwent colposcopy and, from these results, 58 of them underwent a biopsy. The results from the biopsies showed that 16 women had negative histological reports, 13 had CIN 1 and 29 had CIN 2+. In the treatment phase, the 42 women with lesions underwent a variety of treatments, according to the type of lesion. In the post-treatment phase, cytological and colposcopic monitoring was instituted. CONCLUSION: The clinical management consisted of traditional management of screening, diagnosis, diagnostic confirmation, treatment and post-treatment monitoring.

  9. Reporting of cross-over clinical trials of analgesic treatments for chronic pain: Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks systematic review and recommendations.

    Science.gov (United States)

    Gewandter, Jennifer S; McDermott, Michael P; McKeown, Andrew; Hoang, Kim; Iwan, Katarzyna; Kralovic, Sarah; Rothstein, Daniel; Gilron, Ian; Katz, Nathaniel P; Raja, Srinivasa N; Senn, Stephen; Smith, Shannon M; Turk, Dennis C; Dworkin, Robert H

    2016-11-01

    Cross-over trials are typically more efficient than parallel group trials in that the sample size required to yield a desired power is substantially smaller. It is important, however, to consider some issues specific to cross-over trials when designing and reporting them, and when evaluating the published results of such trials. This systematic review evaluated the quality of reporting and its evolution over time in articles of cross-over clinical trials of pharmacologic treatments for chronic pain published between 1993 and 2013. Seventy-six (61%) articles reported a within-subject primary analysis, or if no primary analysis was identified, reported at least 1 within-subject analysis, which is required to achieve the gain in power associated with the cross-over design. For 39 (31%) articles, it was unclear whether analyses conducted were within-subject or between-group. Only 36 (29%) articles reported a method to accommodate missing data (eg, last observation carried forward, n = 29), and of those, just 14 included subjects in the analysis who provided data from only 1 period. Of the articles that identified a within-subject primary analysis, 21 (51%) provided sufficient information for the results to be included in a meta-analysis (ie, estimates of the within-subject treatment effect and variability). These results and others presented in this article demonstrate deficiencies in reporting of cross-over trials for analgesic treatments. Clearer reporting in future trials could improve readers' ability to critically evaluate the results, use these data in meta-analyses, and plan future trials. Recommendations for proper reporting of cross-over trials that apply to any condition are provided.

  10. LDRD report: Smoke effects on electrical equipment

    Energy Technology Data Exchange (ETDEWEB)

    TANAKA,TINA J.; BAYNES JR.,EDWARD E.; NOWLEN,STEVEN P.; BROCKMANN,JOHN E.; GRITZO,LOUIS A.; SHADDIX,CHRISTOPHER R.

    2000-03-01

    Smoke is known to cause electrical equipment failure, but the likelihood of immediate failure during a fire is unknown. Traditional failure assessment techniques measure the density of ionic contaminants deposited on surfaces to determine the need for cleaning or replacement of electronic equipment exposed to smoke. Such techniques focus on long-term effects, such as corrosion, but do not address the immediate effects of the fire. This document reports the results of tests on the immediate effects of smoke on electronic equipment. Various circuits and components were exposed to smoke from different fields in a static smoke exposure chamber and were monitored throughout the exposure. Electrically, the loss of insulation resistance was the most important change caused by smoke. For direct current circuits, soot collected on high-voltage surfaces sometimes formed semi-conductive soot bridges that shorted the circuit. For high voltage alternating current circuits, the smoke also tended to increase the likelihood of arcing, but did not accumulate on the surfaces. Static random access memory chips failed for high levels of smoke, but hard disk drives did not. High humidity increased the conductive properties of the smoke. The conductivity does not increase linearly with smoke density as first proposed; however, it does increase with quantity. The data can be used to give a rough estimate of the amount of smoke that will cause failures in CMOS memory chips, dc and ac circuits. Comparisons of this data to other fire tests can be made through the optical and mass density measurements of the smoke.

  11. Effect of Clinical Teaching Associate Model on Nursing Students' Clinical Skills and Nurses' Satisfaction.

    Science.gov (United States)

    Rahnavard, Zahra; Eybpoosh, Sana; Alianmoghaddam, Narges

    2013-10-02

    Abstract Background and Objectives: The credit of the practice nurses in developing countries, due to gap between theory and practice in nursing education and health care delivery has been questioned by nursing professionals. Therefore, the aims of this study were to investigate the effectiveness of the application of the CTA model in nursing students' clinical skills and to assess the participants' (faculty members, staff nurses, and nursing students) level of satisfaction with the CTA model and with achieving the educational goals in Iran, as a developing country. Methods and Materials: In this experimental study, random sampling was used to assess 104 nursing students' clinical skills, and assess 6 faculty members and 6 staff nurses. After obtaining informed consent, the level of satisfaction was evaluated by a questionnaire and clinical skills were evaluated by standard checklists. Data were assessed and analyzed with SPSS version 15. Results: The results showed that the mean scores of all clinical skills of the students were significantly higher after intervention (pskills in nursing students in Iran as a developing country. Therefore, application of the method is recommended in clinical nursing education systems of such counties.

  12. Effectiveness and safety of natalizumab in real-world clinical practice: Review of observational studies.

    Science.gov (United States)

    van Pesch, Vincent; Sindic, Christian J; Fernández, Oscar

    2016-10-01

    Clinical trials have shown that natalizumab is highly effective for treating relapsing forms of multiple sclerosis (MS). The purpose of this analysis was to conduct a targeted review of data from country-specific observational studies and registries of natalizumab-treated patients with relapsing MS in order to more fully investigate the longer-term effectiveness and safety of this disease-modifying therapy in real-world clinical practice settings. A PubMed search was conducted on March 13, 2014, using the terms (natalizumab AND multiple sclerosis) AND (observational OR registry OR post-marketing OR clinical practice). Only English-language papers that reported effectiveness (in terms of effects on relapses, disability progression, and magnetic resonance imaging findings) and/or safety results from studies were included. Data from 22 studies/registries were included. Annualized relapse rates decreased by 73%-94% from baseline across the studies, with improvement maintained for up to 5 years during natalizumab treatment. Natalizumab effectiveness was also demonstrated via assessment of disability progression (Expanded Disability Status Scale), radiological measures, and no-evidence-of-disease-activity measures (clinical, radiological, and overall). Results were similar among patient groups stratified by level of disease activity. Safety outcomes were consistent with natalizumab's known safety profile. Data from country-specific observational studies and registries varying in size and scope support the effectiveness and safety of natalizumab in a broad range of patients in clinical practice.

  13. Case Reports of Cat Scratch Disease with Typical and Atypical Clinical Manifestations: A Literature Review

    Directory of Open Access Journals (Sweden)

    Gulshan Umbreen

    2017-04-01

    Full Text Available Cat scratch disease (CSD is the most well-known zoonotic disease spread by domestic animals like cats. Cats are the source of Bartonella henselae. Most patients more than ninety percent 3-12 days after a scratch from a cat, undoubtedly a little cat with insects present with one or more erythematous injuries at the site of inoculation, the sore is typically a crusted papule or, once in a while, a pustule. More than half of cases in one study show that the systemic indications went with the lymphadenopathy. These may incorporate fever, discomfort, migraine and anorexia and frequently happen in immunocompromised patients. Atypically clinical manifestations happen are altered mental status, perplexity, prolonged fever, respiratory protestations (atypical pneumonitis, Joint pain, synovitis, Back agony is uncommon. The hypothesis of the study to find out that cat scratch disease cause typical and atypical clinical manifestation. Study was conducted July 2015 to September 2015. The methodology sections of a review article are listed all of the databases and citation indexes that were searched such as Web of Science and PubMed and any individual journals that were searched. Various case reports were mentioned in the study. Case reports of cat scratch diseases with typical and atypical clinical manifestation included in the study. The objective of review of these reporting cases is to make physicians aware about cat scratch diseases and also need to create awareness about cat scratch disease in pet owner. Although it is self-limiting needs to report to health authorities. There are few cases reported in which mostly cases reported in twain, japan, Brazil, Texas, United States, Dhaka, Spain with typical and atypical clinical manifestation

  14. Effectiveness of respiratory rates in determining clinical deterioration

    DEFF Research Database (Denmark)

    Mølgaard, Rikke Rishøj; Larsen, Palle; Håkonsen, Sasa Jul

    2016-01-01

    Review question/objective: The objective of this systematic review is to identify, appraise and synthesize the best available evidence on the effectiveness of manually measuring respiratory rates for 60 s or less in detecting clinical deterioration of inpatients. More specifically, the review...

  15. Exploring Clinical Supervision as Instrument for Effective Teacher Supervision

    Science.gov (United States)

    Ibara, E. C.

    2013-01-01

    This paper examines clinical supervision approaches that have the potential to promote and implement effective teacher supervision in Nigeria. The various approaches have been analysed based on the conceptual framework of instructional supervisory behavior. The findings suggest that a clear distinction can be made between the prescriptive and…

  16. Full-mouth rehabilitation for a patient with dentinogenesis imperfecta: a clinical report.

    Science.gov (United States)

    Bencharit, Sompop; Border, Michael B; Mack, C Russell; Byrd, Warren C; Wright, John T

    2014-10-01

    Dentinogenesis imperfecta (DI) is a genetic disorder affecting the structural integrity of the dentin that can result in weakened dentin. The affected teeth, especially posterior teeth, often need to be extracted due to severe wear or fracture. This frequently yields a loss of posterior occlusion and occlusal vertical dimension. Besides wear and fracture, anterior teeth often have an unesthetic appearance because of discoloration. Current treatments of choice, including composite bonding restorations and, more recently, all-ceramic restorations, are typically suggested to preserve the remaining teeth and tooth structure. However, there are a limited number of studies on dental implants in patients with DI. The effectiveness of dentin bonding and dental implants in patients with DI is not known. This clinical report describes a 32-year-old Asian woman with DI who underwent full-mouth rehabilitation. The posterior occlusion, mostly in the molar areas, was restored with dental implants and ceramometal restorations. The anterior teeth and premolars were restored with bonded lithium disilicate glass-ceramic pressed veneers and crowns made with computer-aided design/computer-aided manufacturing. This case demonstrates that restoring functional occlusion and esthetics for a patient with DI can be completed successfully using contemporary implant therapy and adhesive dentistry.

  17. [Clinical and experimental research of immunomodulatory effect of amisulpride].

    Science.gov (United States)

    Vetlugina, T P; Lobacheva, O A; Al'perina, E L; Zhukova, E N; Semke, A V; Nikitina, V B; Cheĭdo, M A; Idova, G V

    2012-01-01

    Study of immunomodulatory effect of atypical antipsychotic amisulpride has revealed a positive clinical effect after 6-week therapy of schizophrenic patients regarding both positive and negative symptoms. A decrease in activity of humoral immunity factors (B lymphocytes, immunoglobulins, HLADR(+)-cells) identified among schizophrenic patients in the process of amisulpride therapy can be attributed to a positive effect optimizing the ratio Th1/Th2. Amisulpride when used under experimental conditions produced a suppression of IgM-immune response in mice of the C57BL/6J strain. This effect was more expressed in animals with aggressive behavior pattern.

  18. Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports

    Directory of Open Access Journals (Sweden)

    Duric Nezla S

    2012-08-01

    Full Text Available Abstract Background A randomized and controlled clinical study was performed to evaluate the use of neurofeedback (NF to treat attention-deficit/hyperactivity disorder (ADHD in children and adolescents. Methods The ADHD population was selected from an outpatient clinic for Child and Adolescent Mental Health in Norway. Ninety-one of the 275 children and adolescents ranging in age from 6 to 18 years (10.5 years participated in 30 sessions of an intensive NF program. The reinforcement contingency was based on the subjects’ production of cortical beta1 activity (15–18 Hz. The ADHD participants were randomized into three groups, with 30 in the NF group, 31 controls in a group that was given methylphenidate, and 30 in a group that received NF and methylphenidate. ADHD core symptoms were reported by parents using the parent form of the Clinician’s Manual for Assessment by Russell A. Barkley. Results Ninety-one children and adolescents were effectively randomized by age, sex, intelligence and distribution of ADHD core symptoms. The parents reported significant effects of the treatments, but no significant differences between the treatment groups were observed. Conclusions NF was as effective as methylphenidate at treating the attentional and hyperactivity symptoms of ADHD, based on parental reports. Trial registration Current Controlled Trials NCT01252446

  19. The effects of implementing synoptic pathology reporting in cancer diagnosis: a systematic review.

    Science.gov (United States)

    Sluijter, Caro E; van Lonkhuijzen, Luc R C W; van Slooten, Henk-Jan; Nagtegaal, Iris D; Overbeek, Lucy I H

    2016-06-01

    Pathology reporting is evolving from a traditional narrative report to a more structured synoptic report. Narrative reporting can cause misinterpretation due to lack of information and structure. In this systematic review, we evaluate the impact of synoptic reporting on completeness of pathology reports and quality of pathology evaluation for solid tumours. Pubmed, Embase and Cochrane databases were systematically searched to identify studies describing the effect of synoptic reporting implementation on completeness of reporting and quality of pathology evaluation of solid malignant tumours. Thirty-three studies met the inclusion criteria. All studies, except one, reported an increased overall completeness of pathology reports after introduction of synoptic reporting (SR). Most frequently studied cancers were breast (n = 9) and colorectal cancer (n = 16). For breast cancer, narrative reports adequately described 'tumour type' and 'nodal status'. Synoptic reporting resulted in improved description of 'resection margins', 'DCIS size', 'location' and 'presence of calcifications'. For colorectal cancer, narrative reports adequately reported 'tumour type', 'invasion depth', 'lymph node counts' and 'nodal status'. Synoptic reporting resulted in increased reporting of 'circumferential margin', 'resection margin', 'perineural invasion' and 'lymphovascular invasion'. In addition, increased numbers of reported lymph nodes were found in synoptic reports. Narrative reports of other cancer types described the traditional parameters adequately, whereas for 'resection margins' and '(lympho)vascular/perineural invasion', implementation of synoptic reporting was necessary. Synoptic reporting results in improved reporting of clinical relevant data. Demonstration of clinical impact of this improved method of pathology reporting is required for successful introduction and implementation in daily pathology practice.

  20. Clinical and microbiological effects of the initial periodontal therapy

    Directory of Open Access Journals (Sweden)

    Predin Tanja

    2014-01-01

    Full Text Available Introduction. Periodontitis is a destructive inflammatory disease of the tooth-supporting tissues, primarily caused by Gram-negative microorganisms. Thus, the primary objective of cause-related initial periodontal therapy is disruption and removal of the subgingival biofilm. Objective. The aim of this study was to evaluate the clinical and microbiological effects of the initial therapy in patients diagnosed with chronic periodontitis. Methods. Forty patients with chronic periodontitis were included in the study. As a part of the clinical assessment undertaken prior to the initial therapy, as well as one month and three months post-therapy, plaque index, gingival index, papilla bleeding index, probing pocket depth and clinical attachment level were recorded. Microbiological testing was performed prior to the initial therapy and three months after therapy. Polymerase chain reaction assays were used to determine the presence of Porphyromonas gingivalis, Tannerella forsythensis, Prevotella intermedia and Aggregatibacter actinomycetemcomitans. Results. All clinical parameters were significantly reduced after therapy. The prevalence of Aggregatibacter actinomycetemcomitans was reduced by 22.5%, which was a statistically significant decrease compared to the baseline. The prevalence of Porphyromonas gingivalis, Tannerella forsythensis and Prevotella intermedia tended to decrease after therapy; however, the difference did not reach statistical significance. Conclusion. The results of the present study demonstrated the beneficial effects of the initial periodontal therapy on both the clinical and microbiological parameters. [Projekat Ministarstva nauke Republike Srbije, br. 175075

  1. Pilomatricoma as a diagnostic pitfall in clinical practice: Report of two cases and review of literature

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    Pant Ishita

    2010-01-01

    Full Text Available Pilomatricoma (PMC is a relatively uncommon benign skin neoplasm arising from the skin adnexa. Since the first description of PMC in 1880, there has been a gradual increase in understanding of the morphologic features and clinical presentation of this tumor. However, difficulties still persist in making clinical and cytologic diagnosis. We report the clinical and histopathological findings of two cases of pilomatricoma. In case 1, a 10-year-old girl presented with a right upper back mass. In case 2, a nine-year-old girl presented with a left ear lobe mass. The clinical findings in both the cases were suggestive of epidermoid/dermoid cyst. However, subsequent histopathologic examination confirmed these cases as pilomatricoma. This report reveals that pilomatricoma is a frequently misdiagnosed entity in clinical practice. The purpose of this article is to create awareness among clinicians on the possibility of pilomatricoma as a cause of solitary skin nodules, especially those on the head, neck or upper extremities.

  2. 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.

  3. 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

  4. Restoration-Guided Implant Rehabilitation of the Complex Partial Edentulism: a Clinical Report

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    Nikitas Sykaras

    2010-01-01

    Full Text Available Background: The hard and soft tissue deficiency is a limiting factor for the prosthetic restoration and any surgical attempt to correct the anatomic foundation needs to be precisely executed for optimal results. The purpose of this paper is to describe the clinical steps that are needed to confirm the treatment plan and allow its proper execution.Methods: Team work and basic principles are emphasized in a step-by-step description of clinical methods and techniques. This clinical report describes the interdisciplinary approach in the rehabilitation of a partially edentulous patient. The importance of the transitional restoration which sets the guidelines for the proper execution of the treatment plan is especially emphasized along with all the steps that have to be followed.Results: The clinical report describes the diagnostic arrangement of teeth, the ridge augmentation based on the diagnostic evaluation of the removable prosthesis, the implant placement with a surgical guide in the form of the removable partial denture duplicate and finally the special 2-piece design of the final fixed prosthesis.Conclusions: Clinical approach and prosthesis design described above offers a predictable way to restore partial edentulism with a fixed yet retrievable prosthesis, restoring soft tissue and teeth and avoiding an implant supported overdenture.

  5. The impact of a structured clinical training course on interns' self-reported confidence with core clinical urology skills.

    Science.gov (United States)

    Browne, C; Norton, S; Nolan, J M; Whelan, C; Sullivan, J F; Quinlan, M; Sheikh, M; Mc Dermott, T E D; Lynch, T H; Manecksha, R P

    2017-05-04

    Undergraduate training in core urology skills is lacking in many Irish training programmes. Our aim was to assess newly qualified doctors' experience and confidence with core urological competencies. A questionnaire survey covering exposure to urology and confidence with core clinical skills was circulated to all candidates. The group then attended a skills course covering male/female catheterisation, insertion of three-way catheters, bladder irrigation and management of long-term suprapubic catheters. The groups were re-surveyed following the course. Forty-five interns completed the pre-course questionnaire (group 1) and 27 interns completed the post-course questionnaire (group 2). 24/45 (53%) had no experience of catheter insertion on a patient during their undergraduate training. 26/45 (58%) were unsupervised during their first catheter insertion. 12/45 (27%) had inserted a female catheter. 18/45 (40%) had inserted a three-way catheter. 12/45 (27%) had changed a suprapubic catheter. 40/45 (89%) in group 1 reported 'good' or 'excellent' confidence with male urinary catheterisation, compared to 25/27 (92.5%) in group 2. 18/45 (40%) in group 1 reported 'none' or 'poor' confidence with female catheterisation, compared to 7/27 (26%) in group 2. 22/45 (49%) in group 1 reported 'none' or 'poor' confidence with insertion of three-way catheters, compared to 2/27 (7%) in group 2. 32/45 (71%) in group 1 reported 'none' or 'poor' confidence in changing long-term suprapubic catheters, falling to 3/27 (11%) in group 2. This study raises concerns about newly qualified doctors' practical experience in urology. We suggest that this course improves knowledge and confidence with practical urology skills and should be incorporated into intern induction.

  6. Decreasing self-reported cognitive biases and increasing clinical insight through meta-cognitive training in patients with chronic schizophrenia.

    Science.gov (United States)

    Gawęda, Łukasz; Krężołek, Martyna; Olbryś, Joanna; Turska, Agnieszka; Kokoszka, Andrzej

    2015-09-01

    The aim of this study was to assess the impact of meta-cognitive training (MCT) on cognitive biases, symptoms, clinical insight, and general functioning among low-level functioning persons diagnosed with chronic schizophrenia who were attending a daily Community Social Support Group Program; we compared the treatment-as-usual (TAU) condition with the MCT + TAU condition. Forty-four patients diagnosed with chronic schizophrenia were allocated to either the MCT + treatment-as-usual condition or the treatment-as-usual (TAU) condition. Delusion and hallucination severity, cognitive biases, clinical insight, and global functioning were assessed pre- and post-treatment (clinical trial NCT02187692). No significant changes were found in symptom severity as measured with the PSYRATS. Conversely, a medium to large effect size was observed for delusional ideation changes when assessed by the self-report measure (Paranoia Checklist). MCT was found to ameliorate cognitive biases as measured by the self-report scale at large effect size, however, no changes in jumping to conclusions (the Fish Task) and theory of mind deficits ("Reading the Mind in the Eyes" Test) were found in the behavioral tasks. MCT increased insight at large effect size. No changes in global functioning were found between the two conditions. Low intensity intervention. No follow-up assessment was provided. Only PSYRATS was assessed blind to patient allocation. MCT has a beneficial effect on low-functioning chronic schizophrenic patients in ameliorating cognitive biases and increasing clinical insight. Copyright © 2015 Elsevier Ltd. All rights reserved.

  7. The spatial context of clinic-reported sexually transmitted infection in Hong Kong

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    Cheung Georgiana MT

    2010-09-01

    Full Text Available Abstract Background The incidence and prevalence of sexually transmitted infection (STI in China has been on the rise in the past decade. Delineation of epidemiologic pattern is often hampered by its uneven distribution. Spatial distribution is often a neglected aspect of STI research, the description of which may enhance epidemiologic surveillance and inform service development. Methods Over a one month-period, all first time attendees of 6 public STI clinics in Hong Kong were interviewed before clinical consultation using a standard questionnaire to assess their demographic, clinical and behavioural characteristics. A GIS (geographic information system-based approach was adopted with mapping performed. The cases attending the clinics in different locations were profiled. A comparison was made between neighbourhood cases (patients living near a clinic and distant cases (those farther off, by calculating the odds ratio for demographic, behavioural and geographic characteristics. Results Of the 1142 STI patients evaluated, the residence locations of 1029 (90.1% could be geocoded, of which 95.6% were ethnic Chinese and 63.4% male. Geographically only about a quarter lived in the same district as the clinic. STI patients aged 55 or above were more likely to be living in the vicinity of the clinic, located in the same or adjacent tertiary planning unit (a small geographic unit below district level. A majority of patients came from locations a few kilometers from the clinic, the distance of which varies between clinics. Overall, more syphilis cases were reported in patients residing in the same or adjacent tertiary planning unit, while distant cases tended to give a higher risk of inconsistent condom use. There were otherwise no significant clinical and epidemiologic differences between neighbourhood and distant STI cases. Conclusions There was no specific relationship between STI and the residence location of patients as regards their clinical and

  8. Clinical Effects of Fenfluramine in Ten Autistic Subjects. Brief Report.

    Science.gov (United States)

    Klykylo, William M.; And Others

    1985-01-01

    Use of the drug Fenfluramine, which reduces blood serotonin levels and possible problem behaviors, was evaluated. Nine of 10 Ss showed reduced serotonin; none showed significant differences on intelligence tests; and at least two Ss showed marked behavioral changes in less echolalia, perseveration, and motoric disturbance and more increases in…

  9. Clinical utility of chromosomal microarray analysis in prenatal diagnosis: report of first 6 months in clinical practice.

    Science.gov (United States)

    Klugman, Susan; Suskin, Barrie; Spencer, Brianna L; Dar, Pe'er; Bajaj, Komal; Powers, Judith; Reichling, Julie; Wasserman, David; Dolan, Siobhan M; Merkatz, Irwin R

    2014-09-01

    We studied the clinical utility of chromosomal microarray analysis (CMA) in prenatal diagnosis in a clinical setting in New York City. Our center began offering CMA to pregnant women undergoing invasive diagnostic procedures for an abnormal structural finding on ultrasound, maternal age of 35 years or older, or elevated risk on aneuploidy screening, beginning March 2012. Our first six months experience is reported. Benign familial variants were the most common finding (16/22 fetuses). Variants of uncertain significance were frequent, especially when fathers were not available for testing (4/22 fetuses). Most patients undertook CMA as part of evaluation of an ultrasound anomaly (52%). One patient terminated a pregnancy based on an ultrasound finding in the setting of a benign familial variant on CMA, and a second terminated a pregnancy based on a copy number variant identified on CMA. For CMA to be maximally useful in prenatal diagnosis, parental DNA samples as well as robust datasets to provide predictive phenotypic information are required. The most common reason for undertaking CMA was to evaluate an ultrasound anomaly, and benign familial variants were a common finding. Genetic services are required to provide pre- and post-test genetic counseling and help families interpret results.

  10. Quality and consistency of outcome reporting in clinical trials of immunosuppression in renal transplantation.

    Science.gov (United States)

    Hussain, Samia; Knight, Simon R

    2016-11-01

    Interpretation, comparison, and combination of results of clinical trials are reliant on accurate and complete reporting of outcomes. This study aimed to assess the quality and variability in outcome reporting in immunosuppression trials following renal transplantation. All randomized controlled trials comparing immunosuppressive interventions in renal transplant recipients published over a 5-year period were included. Outcomes reported in these studies were extracted, along with data regarding completeness of reporting and whether a clear definition of the method used to measure the outcome was provided. A total of 4760 outcomes were identified from 182 studies. Overall, 90.3% outcomes were completely reported; the remainder had missing data that would preclude use in meta-analysis; 31.5% manuscripts did not define a primary endpoint. Efficacy outcomes were more likely to be clearly defined than safety outcomes (OR: 0.022, P<.001) or patient-reported outcome measures (PROMs) (OR: 0.014, P<.001). PROMs were reported in less than half of manuscripts, and only five reported quality-of-life data using a validated tool. There was significant variability in the way that common efficacy and safety outcomes were defined. Variability in the way that endpoints are selected and reported in trials in renal transplantation makes interpretation and comparison between studies difficult.

  11. Effects of clinical practice environments on clinical teacher and nursing student outcomes.

    Science.gov (United States)

    Babenko-Mould, Yolanda; Iwasiw, Carroll L; Andrusyszyn, Mary-Anne; Laschinger, Heather K S; Weston, Wayne

    2012-04-01

    The purpose of this study was to use a cross-sectional survey design, with an integrated theoretical perspective, to examine clinical teachers' (n = 64) and nursing students' (n = 352) empowerment, teachers' and students' perceptions of teachers' use of empowering teaching behaviors, students' perceptions of nurses' practice behaviors, and students' confidence for practice in acute care settings. In this study, teachers and students were moderately empowered. Teachers reported using a high level of empowering teaching behaviors, which corresponded with students' perceptions of teachers' use of such behaviors. Teachers' empowerment predicted 21% of their use of empowering teaching behaviors. Students reported nurses as using a high level of professional practice behaviors. Students felt confident for professional nursing practice. The findings have implications for practice contexts related to empowering teaching-learning environments and self-efficacy.

  12. The effect of tax reporting in financial reporting

    Directory of Open Access Journals (Sweden)

    Shqipe Xhaferri

    2015-07-01

    Full Text Available This paper analyzes the importance of building financial statements and their compliance with the activities by running an entity, primarily for micro units. Main objective of this paper is to present the necessity of the implementation of legal frameworks in the field of accounting and the application of accounting standards for financial reporting. National Accounting Standards are significant factors to increase the quality of financial information, bringing new technologies, increased competition and culture of service etc. National Accounting Standards help in the sustainable economic development of the country and integration into the EU. This paper analyzes a series of articles in the field of research in the field of accounting. This paper presents the theoretical and practical aspects of a company’s long-term assets, treating the amortization calculated according to accounting standards. An important point is the appearance of these items in the balance sheet. According to the empirical viewpoint, various studies give different results. Also, the entities as a primary source of economic development are part of this paper. The application of accounting standards began in Albania on 1 January 2009. From these date all the units are obliged to draw up financial statements according to national and international standards of accounting. Actually nowadays (starting from the fiscal year 2014 the submission of balance sheet is made electronically.

  13. Design of clinical trials in acute kidney injury: a report from an NIDDK workshop--prevention trials.

    Science.gov (United States)

    Okusa, Mark D; Molitoris, Bruce A; Palevsky, Paul M; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Faubel, Sarah; Kellum, John A; Wald, Ron; Chertow, Glenn M; Levin, Adeera; Waikar, Sushrut S; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom H; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing CKD and progressing to ESRD. No proven effective pharmacologic therapies are currently available for the prevention or treatment of AKI. Advances in addressing this unmet need will require the development of novel therapeutic agents based on precise understanding of key pathophysiological events and the implementation of well designed clinical trials. To address this need, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored the "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" workshop in December 2010. The event brought together representatives from academia, industry, the National Institutes of Health, and the US Food and Drug Administration. We report the discussions of workgroups that developed outlines of clinical trials for the prevention of AKI in two patient populations: patients undergoing elective surgery who are at risk for or who develop AKI, and patients who are at risk for contrast-induced AKI. In both of these populations, primary prevention or secondary therapy can be delivered at an optimal time relative to kidney injury. The workgroups detailed primary and secondary endpoints for studies in these groups, and explored the use of adaptive clinical trial designs for trials of novel preventive strategies to improve outcomes of patients with AKI.

  14. Clinical Data Warehouse: An Effective Tool to Create Intelligence in Disease Management.

    Science.gov (United States)

    Karami, Mahtab; Rahimi, Azin

    2017-09-21

    Clinical business intelligence tools such as clinical data warehouse enable health care organizations to objectively assess the disease management programs that affect the quality of patients' life and well-being in public. The purpose of these programs is to reduce disease occurrence, improve patient care, and decrease health care costs. Therefore, applying clinical data warehouse can be effective in generating useful information about aspects of patient care to facilitate budgeting, planning, research, process improvement, external reporting, benchmarking, and trend analysis, as well as to enable the decisions needed to prevent the progression or appearance of the illness aligning with maintaining the health of the population. The aim of this review article is to describe the benefits of clinical data warehouse applications in creating intelligence for disease management programs.

  15. Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm.

    Science.gov (United States)

    Wicks, Paul; Vaughan, Timothy E; Massagli, Michael P; Heywood, James

    2011-05-01

    Patients with serious diseases may experiment with drugs that have not received regulatory approval. Online patient communities structured around quantitative outcome data have the potential to provide an observational environment to monitor such drug usage and its consequences. Here we describe an analysis of data reported on the website PatientsLikeMe by patients with amyotrophic lateral sclerosis (ALS) who experimented with lithium carbonate treatment. To reduce potential bias owing to lack of randomization, we developed an algorithm to match 149 treated patients to multiple controls (447 total) based on the progression of their disease course. At 12 months after treatment, we found no effect of lithium on disease progression. Although observational studies using unblinded data are not a substitute for double-blind randomized control trials, this study reached the same conclusion as subsequent randomized trials, suggesting that data reported by patients over the internet may be useful for accelerating clinical discovery and evaluating the effectiveness of drugs already in use.

  16. [Cerebral hemorrhage induced by low-dose streptokinase: a pharmacologic paradox? Report of a clinical case].

    Science.gov (United States)

    Fedeli, F; Skouse, D; Messina, A

    1997-01-01

    A case of an important intracranial hemorrhage after a low dose (approx. 500,000 UI) of streptokinase in a 60 year-old woman suffering from myocardial infarction is presented. Clinical, electrocardiographic, echocardiographic, lab and tomographic findings are described. The authors suggest a pharmacokinetic mechanism which could be responsible of a "paradox effect" (a powerful and dangerous effect of the drug when given in low dose) and they wonder whether in case of allergic reactions should it be better not to stop the infusion of the thrombolytic drug and be more liberal with the "symptomatic" drugs. Tha patient is still alive and the clinical conditions slowly progressing.

  17. Design of clinical trials in acute kidney injury: report from an NIDDK workshop on trial methodology.

    Science.gov (United States)

    Palevsky, Paul M; Molitoris, Bruce A; Okusa, Mark D; Levin, Adeera; Waikar, Sushrut S; Wald, Ron; Chertow, Glenn M; Murray, Patrick T; Parikh, Chirag R; Shaw, Andrew D; Go, Alan S; Faubel, Sarah G; Kellum, John A; Chinchilli, Vernon M; Liu, Kathleen D; Cheung, Alfred K; Weisbord, Steven D; Chawla, Lakhmir S; Kaufman, James S; Devarajan, Prasad; Toto, Robert M; Hsu, Chi-yuan; Greene, Tom; Mehta, Ravindra L; Stokes, John B; Thompson, Aliza M; Thompson, B Taylor; Westenfelder, Christof S; Tumlin, James A; Warnock, David G; Shah, Sudhir V; Xie, Yining; Duggan, Emily G; Kimmel, Paul L; Star, Robert A

    2012-05-01

    Acute kidney injury (AKI) remains a complex clinical problem associated with significant short-term morbidity and mortality and lacking effective pharmacologic interventions. Patients with AKI experience longer-term risks for progressive chronic ESRD, which diminish patients' health-related quality of life and create a larger burden on the healthcare system. Although experimental models have yielded numerous promising agents, translation into clinical practice has been unsuccessful, possibly because of issues in clinical trial design, such as delayed drug administration, masking of therapeutic benefit by adverse events, and inadequate sample size. To address issues of clinical trial design, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored a workshop titled "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" in December 2010. Workshop participants included representatives from academia, industry, and government agencies whose areas of expertise spanned basic science, clinical nephrology, critical care medicine, biostatistics, pharmacology, and drug development. This document summarizes the discussions of collaborative workgroups that addressed issues related to patient selection, study endpoints, the role of novel biomarkers, sample size and power calculations, and adverse events and pilot/feasibility studies in prevention and treatment of AKI. Companion articles outline the discussions of workgroups for model trials related to prevention or treatment of established AKI in different clinical settings, such as in patients with sepsis.

  18. Clinical importance of carbapenem hypersensitivity in patients with self-reported and documented penicillin allergy.

    Science.gov (United States)

    Prescott, William A; Kusmierski, Kristen A

    2007-01-01

    The risk of carbapenem hypersensitivity in patients with self-reported or documented penicillin allergy needs to be determined so that practitioners can make better-informed decisions regarding antibiotic therapy for this patient population. The risk of cross-reactivity between penicillin and carbapenem antibiotics initially was reported to approach 50%. Recent retrospective studies have suggested that the clinical risk of cross-hypersensitivity between these two drug classes is 9.2-11%, which is significantly lower than initially reported. Patients whose history of penicillin allergy is self-reported and is not type 1 may be at moderate risk for hypersensitivity when treated with a carbapenem antibiotic. The risk of hypersensitivity appears to be higher in patients whose penicillin allergy was documented by a health care provider, those with several antibiotic allergies, and those with a positive penicillin skin test result or a history of type 1 penicillin hypersensitivity.

  19. Reporting unit size and measurement uncertainty: current Australian practice in clinical chemistry and haematology.

    Science.gov (United States)

    Hawkins, Robert C; Badrick, Tony

    2015-08-01

    In this study we aimed to compare the reporting unit size used by Australian laboratories for routine chemistry and haematology tests to the unit size used by learned authorities and in standard laboratory textbooks and to the justified unit size based on measurement uncertainty (MU) estimates from quality assurance program data. MU was determined from Royal College of Pathologists of Australasia (RCPA) - Australasian Association of Clinical Biochemists (AACB) and RCPA Haematology Quality Assurance Program survey reports. The reporting unit size implicitly suggested in authoritative textbooks, the RCPA Manual, and the General Serum Chemistry program itself was noted. We also used published data on Australian laboratory practices.The best performing laboratories could justify their chemistry unit size for 55% of analytes while comparable figures for the 50% and 90% laboratories were 14% and 8%, respectively. Reporting unit size was justifiable for all laboratories for red cell count, >50% for haemoglobin but only the top 10% for haematocrit. Few, if any, could justify their mean cell volume (MCV) and mean cell haemoglobin concentration (MCHC) reporting unit sizes.The reporting unit size used by many laboratories is not justified by present analytical performance. Using MU estimates to determine the reporting interval for quantitative laboratory results ensures reporting practices match local analytical performance and recognises the inherent error of the measurement process.

  20. A real-time safety and quality reporting system: assessment of clinical data and staff participation.

    Science.gov (United States)

    Rahn, Douglas A; Kim, Gwe-Ya; Mundt, Arno J; Pawlicki, Todd

    2014-12-01

    To report on the use of an incident learning system in a radiation oncology clinic, along with a review of staff participation. On September 24, 2010, our department initiated an online real-time voluntary reporting system for safety issues, called the Radiation Oncology Quality Reporting System (ROQRS). We reviewed these reports from the program's inception through January 18, 2013 (2 years, 3 months, 25 days) to assess error reports (defined as both near-misses and incidents of inaccurate treatment). During the study interval, there were 60,168 fractions of external beam radiation therapy and 955 brachytherapy procedures. There were 298 entries in the ROQRS system, among which 108 errors were reported. There were 31 patients with near-misses reported and 27 patients with incidents of inaccurate treatment reported. These incidents of inaccurate treatment occurred in 68 total treatment fractions (0.11% of treatments delivered during the study interval). None of these incidents of inaccurate treatment resulted in deviation from the prescription by 5% or more. A solution to the errors was documented in ROQRS in 65% of the cases. Errors occurred as repeated errors in 22% of the cases. A disproportionate number of the incidents of inaccurate treatment were due to improper patient setup at the linear accelerator (Psafety and quality in patient care. Copyright © 2014 Elsevier Inc. All rights reserved.

  1. A Case Report on the Effect of Sham Acupuncture.

    Science.gov (United States)

    Zotelli, Vera Lucia Rasera; Grillo, Cássia Maria; Sousa, Maria da Luz Rosário de

    2016-10-01

    When nausea, an extremely unpleasant symptom, is experienced during dental treatment, it generates disorders and obstacles for both the patient and the professional, compromising the good quality of dental care. Clinical studies have confirmed the antiemetic action of acupuncture and shown its use for the treatment of nausea and vomiting. In the scientific literature there are several recent studies that address the placebo effect of acupuncture. The aim of this manuscript is to present a case report of a 46-year-old Caucasian male patient, who had severe symptoms of nausea while undergoing dental care. Treatment with sham acupuncture (acupuncture simulation) obtained a positive result of nausea prevention. We will discuss three possible hypotheses concerning this result: (1) there was action of Deqi; (2) high expectations of the patient; and (3) association with specific learned response. The patient in this case report received nonpenetrating sham acupuncture at acupoint Neiguan (PC6), which resulted in the complete remission of nausea during an intra-oral impression-taking procedure, but it is unclear whether the placebo effect was triggered by the action of Deqi, the high expectations of the patient, an association with a learned response, or by the interaction of all these factors. Copyright © 2016. Published by Elsevier B.V.

  2. Spina bifida with higher position of sacral hiatus: a case report with clinical implications.

    Science.gov (United States)

    Srijit, D; Shipra, P

    2007-01-01

    Spina bifida is a developmental defect in the vertebral column, in which the laminae fail to fuse and thereby the spinal cord is relatively unprotected. We report a case of spina bifida, in a dried specimen of sacrum, characterized by a prominent S1 spine and a higher sacral hiatus. Conventional textbooks of anatomy provide less information about the clinical implications of such anomalies and research studies are the only source of information. The present study, discusses in detail, the structural and radiological aspects of spina bifida, with a higher sacral hiatus. Precise knowledge of normal and abnormal anatomy of the sacrum may be clinically important for anesthetists, neurologists, radiologists and orthopedic surgeons, in their clinical practice (Fig. 3, Ref. 16). Full Text (Free, PDF) www.bmj.sk

  3. Clinical findings in two cases of atypical scrapie in sheep: a case report

    Directory of Open Access Journals (Sweden)

    Chaplin Melanie

    2007-02-01

    Full Text Available Abstract Background Atypical scrapie is a recently recognised form of transmissible spongiform encephalopathy of sheep that differs from classical scrapie in its neuropathological and biochemical features. Most cases are detected in apparently healthy sheep and information on the clinical presentation is limited. Case presentation This report describes the clinical findings in two sheep notified as scrapie suspects and confirmed as atypical scrapie cases by immunohistochemistry and Western immunoblotting. Although both sheep displayed signs suggestive of a cerebellar dysfunction there was considerable variation in the individual clinical signs, which were similar to classical scrapie. Conclusion Any sheep presenting with neurological gait deficits should be assessed more closely for other behavioural, neurological and physical signs associated with scrapie and their presence should lead to the suspicion of scrapie.

  4. Trichotillomania: a case report with clinical and dermatoscopic differential diagnosis with alopecia areata*

    Science.gov (United States)

    Pinto, Ana Cecília Versiani Duarte; de Andrade, Tatiana Cristina Pedro Cordeiro; de Brito, Fernanda Freitas; da Silva, Gardênia Viana; Cavalcante, Maria Lopes Lamenha Lins; Martelli, Antonio Carlos Ceribelli

    2017-01-01

    Trichotillomania is a psychodermatologic disorder characterized by uncontrollable urge to pull one's own hair. Differential diagnoses include the most common forms of alopecia such as alopecia areata. It is usually associated with depression and obsessive-compulsive disorder. Trichotillomania treatment standardization is a gap in the medical literature. Recent studies demonstrated the efficacy of N-acetylcysteine (a glutamate modulator) for the treatment of the disease. We report the clinical case of a 12-year-old female patient who received the initial diagnosis of alopecia areata, but presented with clinical and dermoscopic features of trichotillomania. She was treated with the combination of psychotropic drugs and N-acetylcysteine with good clinical response. Due to the chronic and recurring nature of trichotillomania, more studies need to be conducted for the establishment of a formal treatment algorithm. PMID:28225970

  5. Clinical and diagnostic challenges in a rare case of motor weakness with endocrinopathy: A case report

    Directory of Open Access Journals (Sweden)

    Ravinder Garg

    2016-01-01

    Full Text Available Electrolyte imbalance always poses challenging situations to the attending intensivists, particularly if it is associated with endocrinopathies and other comorbidities. One such rare clinical scenario is hypokalemic periodic paralysis (HPP due to hyperthyroidism. The epidemiology of such a condition is slightly higher among males of Asian origin as compared to its universal occurrence. The diagnostic challenges in this clinical situation can lead to higher morbidity if timeliness is compromised from the presentation to active management. Moreover, atypical presentation of this pathologic condition further compounds the problem if it is associated with overt hyperthyroidism. Here, we report a unique case that presented to the emergency medicine department of our institute with weakness of all the four limbs and in which we faced all the diagnostic and management challenges as the clinical condition of hypokalemia was somehow dominated by overt hyperthyroidism.

  6. Individual lithium disilicate crowns in a full-arch, implant-supported rehabilitation: a clinical report.

    Science.gov (United States)

    Maló, Paulo; de Sousa, Sérgio Tavares; De Araújo Nobre, Miguel; Moura Guedes, Carlos; Almeida, Ricardo; Roma Torres, António; Legatheaux, João; Silva, António

    2014-08-01

    This clinical report presents the clinical outcome of a maxillary full-arch implant-supported fixed rehabilitation with lithium disilicate reinforced glass ceramic monolithic crowns opposing a mandibular metal-acrylic implant-supported fixed rehabilitation in a 62-year-old woman. Eight implants were successfully placed (four maxillary, four mandibular), and no complications occurred in the postoperative or maintenance periods. Six months after delivery, the maxillary and mandibular prostheses were found to be clinically, biologically, and mechanically stable, and the patient was satisfied with the esthetics and her ability to function. Although the present indications for the use of lithium disilicate are still restricted to tooth-borne restorations, it is possible to successfully rehabilitate edentulous patients through implant-supported fixed prostheses using lithium disilicate reinforced glass ceramic monolithic crowns.

  7. Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.

    Science.gov (United States)

    Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H

    2016-12-06

    To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p Neurology.

  8. Brief clinical report: an infant with duplication of 17q21 lead to 17qter.

    Science.gov (United States)

    Gallien, J U; Neu, R L; Wynn, R J; Steinberg-Warren, N; Bannerman, R M

    1981-01-01

    Duplication of the distal part of 17q has been reported in 4 patients [1,2]. We are reporting clinical, autopsy, and cytogenetic data on an additional patient whose condition was due to a familial translocation in which the patient's chromosome constitution is 46,XX, der(4),t(4;17)(p16;q21) pat. The phenotype of the five known patients with this duplication is very similar, and their manifestations are distinct enough to be clinically recognizable. Abnormalities common to all five patients are severe growth impairment, craniofacial anomalies with severe hypertelorism, frontal bossing and temporal narrowness, a widow's peak, narrow palpebral fissures, a thin upper lip overlapping a thin lower lip with down-turned corners of the mouth, micrognathia, apparently low-set and deformed ears, short webbed neck, and hyperlaxity of the limbs.

  9. Single Tooth Replacement Using InCeram Resin Bonded Fixed Partial Denture: A Clinical Report.

    Directory of Open Access Journals (Sweden)

    Elnaz Moslehifard

    2014-02-01

    Full Text Available This clinical report describes a treatment option for replacement of a missing mandibular anterior tooth using InCeram resin bonded fixed partial denture (RBFPD. The conventional approach for replacing mandibular incisors dictates the placement of either a conventional porcelain-fused-to-metal (PFM bridge, Maryland bridge, or fiber-reinforced composite veneer bridge and several appearance-related disadvantages have been reported in the use of a prosthesis that incorporates a metal substructure. The InCeram bridge is a minimally invasive restoration and eliminates undesirable incisal graying frequently observed in metal RBFPDs. This method was successfully clinically applied to overcome shortcomings of other approaches that may require a minimal invasive technique to preserve lasting sound tooth structure.

  10. [Reflections on the clinical reports «minimum data set»].

    Science.gov (United States)

    Prieto de Paula, J M; Franco Hidalgo, S

    2012-02-01

    Royal Decree 1093/2010 (3 September 2010) establishes the minimum data set that the clinical reports of discharges and outpatient visits elaborated in the facilities of the National Health System should contain, among others. Until then, the Ministerial Order 221/1984, that only required the drawing up of a discharge report for patients seen in a hospital-regime health care establishment, was in force. In spite of the importance of these documents, their quality is far from that desired, especially that of the reports on visits, which, among other things, are not performed in a high percentage of the cases. Recently the Sociedad Española de Medicina Interna (SEMI) (Spanish Society of Internal Medicine), in collaboration with other scientific societies, issued some recommendations for the drawing up of the discharge reports. In this present work, a series of thoughts are made on the implications of the new decree, especially in the case of the reports of the outpatient clinics. Copyright © 2011 Elsevier España, S.L. All rights reserved.

  11. Fixed maxillary and mandibular zirconia implant frameworks milled with anatomically contoured molars: a clinical report.

    Science.gov (United States)

    Al-Mazedi, Mohammad; Razzoog, Michael E; Yaman, Peter

    2014-11-01

    Retrospective studies on restoring the patients with complete edentulism have reported a variety of complications, including the excessive wear and fracture of the acrylic resin teeth. Approaches to slow the process of wear include the use of porcelain teeth or altering the occlusal surface of acrylic resin teeth with amalgam or gold. Two 1-piece fixed zirconia implant frameworks masked with gingival porcelain and stained anatomically contoured first and second molars and individual ceramic crowns were used to restore both arches to optimum function and esthetics. This clinical report describes the steps for one method of providing the fixed prosthetic needs of the patients who is edentulous.

  12. Clinically lesser known entity in India: A Report of two cases of Melioidosis

    Directory of Open Access Journals (Sweden)

    Purabi Barman

    2013-01-01

    Full Text Available Melioidosis is endemic in the South Asian regions, like Thailand, Singapore Malaysia and Australia. The disease is more pronounced in the southern part of the country. It is caused by Burkholderia pseudomallei which causes systemic involvement, morbidity and mortality associated with the disease is high. Due to highly varied clinical presentation, and low general awareness this infection is largely underdiagnosed and under reported in our country. Most laboratories in the country still rely on conventional culturing methods with their low sensitivity, adding to the under reporting. To enhance physician awareness we describe here two cases who presented to our institute after months of misdiagnosis.

  13. Malignant pigmented villonodular synovitis in the knee - report of a case with rapid clinical progression.

    Science.gov (United States)

    Imakiire, Naoaki; Fujino, Takashi; Morii, Takeshi; Honya, Keita; Mochizuki, Kazuo; Satomi, Kazuhiko; Fujioka, Yasunori

    2011-01-07

    Malignant pigmented villonodular synovitis (PVNS) (or malignant giant cell tumor of tendon sheath (GCTTS) is an extremely rare condition defined as a malignant lesion occurring with concomitant or previously documented PVNS at the same site. To date, only less than 20 cases have been reported in English literatures. We report a case of malignant PVNS in the knee in a 56-year-old woman with unpredictable rapid progression. This case raised a caution that when atypical components in specimens of recurrent benign PVNS are detected, even if low-grade or tiny, both pathologists and surgeons should consider the risk of malignant PVNS, which could display aggressive clinical progression.

  14. Discrepancy between information reported by the victims of sexual assaults and clinical forensic findings

    DEFF Research Database (Denmark)

    Scherer, Susanne; Hansen, Steen Holger; Lynnerup, Niels

    2014-01-01

    INTRODUCTION: From the clinical forensic examination reports made at the Department of Forensic Medicine, the University of Copenhagen, in 2007 concerning rape, attempted rape and sexual assault (RAS), information about the assault, including both violence and the perpetrator's line of sexual...... by slight, blunt force. Information on line of sexual action was present in 148 cases. A total of 123 victims reported penetration: 94% vaginal, 16% anal and 20% oral. Three were exposed to anal penetration only. Eleven perpetrators used a condom. 50% of the cases with vaginal and/or anal penetration had...

  15. Clinically lesser known entity in India: A Report of two cases of Melioidosis.

    Science.gov (United States)

    Barman, Purabi; Kaur, Ravneet; Kumar, Kamlesh

    2013-01-01

    Melioidosis is endemic in the South Asian regions, like Thailand, Singapore Malaysia and Australia. The disease is more pronounced in the southern part of the country. It is caused by Burkholderia pseudomallei which causes systemic involvement, morbidity and mortality associated with the disease is high. Due to highly varied clinical presentation, and low general awareness this infection is largely underdiagnosed and under reported in our country. Most laboratories in the country still rely on conventional culturing methods with their low sensitivity, adding to the under reporting. To enhance physician awareness we describe here two cases who presented to our institute after months of misdiagnosis.

  16. Clinical and attentional effects of acute nicotine treatment in Tourette's syndrome.

    Science.gov (United States)

    Howson, Anne L; Batth, Sue; Ilivitsky, Vadim; Boisjoli, Armand; Jaworski, Martine; Mahoney, Colleen; Knott, Verner J

    2004-04-01

    Evidence from pre-clinical infrahuman investigations, open-label clinical trials, and a single controlled trial found acute nicotine treatment potentiated up to 4 weeks neuroleptic-induced reductions of dyskinetic symptoms characterizing Tourette's syndrome (TS). Given the attentional disturbances associated with this syndrome, and the improvements in attentional processes reported with nicotine, this randomized, double-blind, placebo-controlled trial examined the acute (4 h) and sustained (2 weeks) effects of a single dose of transdermal nicotine on clinical (i.e., tics), attentional (continuous performance task, event-related potential, patient and parental reports) and behavioral symptoms in 23 children and adolescents with TS receiving neuroleptic treatment. In the 14 evaluable patients with complete primary efficacy data, nicotine (compared to placebo) failed to alter symptoms at 4 h but counteracted ERP-P300 signs of diminished attention seen 2 weeks following placebo treatment. Secondary efficacy measures, including patient self-reports and parental ratings, found nicotine to reduce complex tics and improve behaviors related to inattention. Additional work with intermittent dosing schedules is required to characterize optimal clinical and cognitive effects with nicotine treatment.

  17. Clinical effectiveness of atypical antipsychotics in elderly patients with psychosis.

    Science.gov (United States)

    Masand, Prakash

    2004-11-01

    The elderly represent a unique patient group in the sense that they have a high prevalence of psychotic symptoms that are a manifestation of a variety of psychiatric, neurological and organic disorders. Treatment is complicated by several factors including comorbid diagnoses (psychiatric and medical), polypharmacy, age-related changes in pharmacokinetics and pharmacodynamics and high susceptibility to adverse events. Elderly patients require pharmacological interventions that are effective in reducing symptoms but also are well tolerated, improve everyday functioning, subjective well-being and treatment adherence and reduce family/career burden. The ability of an antipsychotic to fulfil these requirements determines its clinical effectiveness. To date, few studies have investigated the clinical effectiveness of atypical antipsychotics in elderly patients. However, clear differences exist between the available agents, particularly with regard to tolerability profiles, which have a major impact on the clinical outcome of patients. Clinicians should select an agent that is not only effective in reducing psychotic symptoms but, more importantly, one that has a low incidence of adverse events, such as extrapyramidal symptoms (EPS) and neurocognitive problems, which are of concern in the elderly.

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

    Science.gov (United States)

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

    2016-12-01

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

  19. Clinical Trial Registries Are of Minimal Use for Identifying Selective Outcome and Analysis Reporting

    Science.gov (United States)

    Norris, Susan L.; Holmer, Haley K.; Fu, Rongwei; Ogden, Lauren A.; Viswanathan, Meera S.; Abou-Setta, Ahmed M.

    2014-01-01

    Objective: This study aimed to examine selective outcome reporting (SOR) and selective analysis reporting (SAR) in randomized controlled trials (RCTs) and to explore the usefulness of trial registries for identifying SOR and SAR. Study Design and Setting: We selected one "index outcome" for each of three comparative effectiveness reviews…

  20. Cognitive-enhancing effects of aripiprazole: a case report

    Directory of Open Access Journals (Sweden)

    Galderisi Silvana

    2008-10-01

    Full Text Available Abstract Patients with schizophrenia often present mild to severe cognitive deficits which contribute to their social disability. Second-generation antipsychotics have shown only mild to moderate beneficial effects on cognition. The present case report suggests cognitive enhancing effects of aripiprazole, a dopamine partial agonist, shown to increase dopamine release in prefrontal cortex in animal studies. The patient was in his first-episode of schizophrenia, and had no previous exposure to first-generation antipsychotics. Before schizophrenia onset his cognitive functioning was poor and he could not attend regular courses to reach his high school degree; he started but was not able to attend the University courses for several years. After schizophrenia onset, he was treated, in sequence, with olanzapine, amisulpride and aripiprazole. During treatment with the first two second-generation antipsychotics, positive symptoms markedly improved while cognitive functioning remained poor. During treatment with aripiprazole, clinical remission was obtained and the patient was able to attend university courses and pass several examinations. Social functioning was markedly improved. Aripiprazole demonstrated cognitive enhancing effects in this patient. These effects were long-lasting and paralleled by a positive impact on social functioning.

  1. Complete removable dental prosthesis with the swing lock system: a clinical report.

    Science.gov (United States)

    Aggarwal, Harshit; Cho, Seok-Hwan

    2014-11-01

    This clinical report describes the fabrication of a maxillary complete removable dental prosthesis with the swing lock system. The patient presented with large undercuts on the buccal and labial areas of the edentulous maxillary arch and a history of various failed alveoloplasty procedures that had attempted to remove the exostoses preventing denture insertion. The prosthodontic planning and treatment approach are discussed. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  2. Prosthetic rehabilitation of edentulous patient with limited oral access: A clinical report

    Directory of Open Access Journals (Sweden)

    Sandeep Kumar

    2012-01-01

    Full Text Available Microstomia may result from surgical treatment of orofacial neoplasms, cleft lips, maxillofacial trauma, burns, radiotherapy or scleroderma. A maximal oral opening that is smaller than the size of a complete denture can make prosthetic treatment challenging. This clinical report presents the prosthodontic management of a total edentulous patient with microstomia. Sectional mandibular and maxillary trays and foldable mandibular and maxillary denture were fabricated for the total edentulous patient.

  3. Automated ancillary cancer history classification for mesothelioma patients from free-text clinical reports

    OpenAIRE

    Wilson, Richard A.; Chapman, Wendy W.; Shawn J DeFries; Becich, Michael J; Chapman, Brian E.

    2010-01-01

    Background: Clinical records are often unstructured, free-text documents that create information extraction challenges and costs. Healthcare delivery and research organizations, such as the National Mesothelioma Virtual Bank, require the aggregation of both structured and unstructured data types. Natural language processing offers techniques for automatically extracting information from unstructured, free-text documents. Methods: Five hundred and eight history and physical reports from mesoth...

  4. [Hemobilia secondary to percutaneous hepatic biopsy. Report of a clinical case].

    Science.gov (United States)

    Vertemati, G; Russo, R; Semeraro, M V; Ballerini, A; Carzaniga, P L; Gatti, A

    1995-04-01

    The increasingly frequent use of invasive diagnostic and therapeutic procedures concerning the hepatobiliary system has led to a rise in the incidence of hemobilia as well as altering its etiological status. The authors report a clinical case of hemobilia secondary to percutaneous hepatic biopsy which was brought to their attention. This is followed by a short discussion of the etiopatogenesis and diagnostic and therapeutic strategies with special reference to the ratio between the advantages/limits of the methods now available.

  5. Fixation of a severely resorbed mandible for complete arch screw-retained rehabilitation: A clinical report.

    Science.gov (United States)

    Fabris, Vinicius; Bacchi, Atais

    2016-05-01

    Severely resorbed mandibles with placed endosteal dental implants can fracture. Therefore, techniques to reduce the risk or minimize the consequences of these fractures are needed. This clinical report presents a technique for placing a titanium plate in a severely resorbed mandible subjected to complete-arch implant therapy. The titanium plate is placed in the same surgical procedure as the implants, allowing immediate implant loading. This technique provides safe implant-supported treatment for patients with severe mandibular resorption.

  6. Maxillary cement retained implant supported monolithic zirconia prosthesis in a full mouth rehabilitation: a clinical report

    OpenAIRE

    Sadid-Zadeh, Ramtin; Liu, Perng-Ru; Aponte-Wesson, Ruth; O'Neal, Sandra J

    2013-01-01

    This clinical report presents the reconstruction of a maxillary arch with a cement retained implant supported fixed prosthesis using a monolithic zirconia generated by CAD/CAM system on eight osseointegrated implants. The prosthesis was copy milled from an interim prosthesis minimizing occlusal adjustments on the definitive prosthesis at the time of delivery. Monolithic zirconia provides high esthetics and reduces the number of metal alloys used in the oral cavity.

  7. Maxillary cement retained implant supported monolithic zirconia prosthesis in a full mouth rehabilitation: a clinical report.

    Science.gov (United States)

    Sadid-Zadeh, Ramtin; Liu, Perng-Ru; Aponte-Wesson, Ruth; O'Neal, Sandra J

    2013-05-01

    This clinical report presents the reconstruction of a maxillary arch with a cement retained implant supported fixed prosthesis using a monolithic zirconia generated by CAD/CAM system on eight osseointegrated implants. The prosthesis was copy milled from an interim prosthesis minimizing occlusal adjustments on the definitive prosthesis at the time of delivery. Monolithic zirconia provides high esthetics and reduces the number of metal alloys used in the oral cavity.

  8. Artifactual Hypoglycaemia in Systemic Sclerosis and Raynaud's Phenomenon: A Clinical Case Report and Short Review

    Science.gov (United States)

    Suryawanshi, A.

    2016-01-01

    Background. Artifactual hypoglycaemia, defined as a discrepancy between glucometer (capillary) and plasma glucose levels, may lead to overtreatment and costly investigations. It is not infrequently observed in patients with Raynaud's phenomenon due to vascular capillary distortion, yet this is clinically underappreciated. Case Report. We report a 76-year-old woman with systemic sclerosis and Raynaud's phenomenon, who presented with upper gastrointestinal bleeding and found to have concomitant persistent hypoglycaemia (1.0–2.7mmol/L) on a point-of-care glucometer in the absence hypoglycaemic symptoms. She underwent a 2-week hospital admission, repeated glucose monitoring, hydrocortisone replacement and dextrose infusions, with consequent hyperglycaemia on plasma measurements. Clinically, she did not satisfy Whipple's triad and radiological investigations failed to identify pituitary or pancreatic pathology. A 72-hour fast was negative for hyperinsulinaemia or exogenous insulin use and her sulphonylurea metabolite urinary screen was negative. Discussion. Treatment of low capillary blood glucose is usually met with clinical impetus to treat, even when hypoglycaemic symptoms are lacking. The correct diagnosis may have been achieved had there been an observation of her cold hands, scleroderma facies, and consideration of the likely distorted peripheral microvasculature. Early identification of this presumably rare clinical scenario may have prevented overtreatment, altered methods of monitoring, and avoided unnecessary investigations. PMID:28116181

  9. Artifactual Hypoglycaemia in Systemic Sclerosis and Raynaud's Phenomenon: A Clinical Case Report and Short Review.

    Science.gov (United States)

    Bishay, R H; Suryawanshi, A

    2016-01-01

    Background. Artifactual hypoglycaemia, defined as a discrepancy between glucometer (capillary) and plasma glucose levels, may lead to overtreatment and costly investigations. It is not infrequently observed in patients with Raynaud's phenomenon due to vascular capillary distortion, yet this is clinically underappreciated. Case Report. We report a 76-year-old woman with systemic sclerosis and Raynaud's phenomenon, who presented with upper gastrointestinal bleeding and found to have concomitant persistent hypoglycaemia (1.0-2.7mmol/L) on a point-of-care glucometer in the absence hypoglycaemic symptoms. She underwent a 2-week hospital admission, repeated glucose monitoring, hydrocortisone replacement and dextrose infusions, with consequent hyperglycaemia on plasma measurements. Clinically, she did not satisfy Whipple's triad and radiological investigations failed to identify pituitary or pancreatic pathology. A 72-hour fast was negative for hyperinsulinaemia or exogenous insulin use and her sulphonylurea metabolite urinary screen was negative. Discussion. Treatment of low capillary blood glucose is usually met with clinical impetus to treat, even when hypoglycaemic symptoms are lacking. The correct diagnosis may have been achieved had there been an observation of her cold hands, scleroderma facies, and consideration of the likely distorted peripheral microvasculature. Early identification of this presumably rare clinical scenario may have prevented overtreatment, altered methods of monitoring, and avoided unnecessary investigations.

  10. Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.

    Science.gov (United States)

    Schnell, Oliver; Barnard, Katharine; Bergenstal, Richard; Bosi, Emanuele; Garg, Satish; Guerci, Bruno; Haak, Thomas; Hirsch, Irl B; Ji, Linong; Joshi, Shashank R; Kamp, Maarten; Laffel, Lori; Mathieu, Chantal; Polonsky, William H; Snoek, Frank; Home, Philip

    2017-07-01

    Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.

  11. Effect of acupressure on preoperative anxiety: a clinical trial.

    Science.gov (United States)

    Valiee, Sina; Bassampour, Shiva Sadat; Nasrabadi, Alireza Nikbakht; Pouresmaeil, Zahra; Mehran, Abbas

    2012-08-01

    Preoperative anxiety, as an emotional reaction, is common among patients undergoing surgery. The purpose of this study was to examine the effect of acupressure on preoperative anxiety before abdominal surgery. The 70 subjects of this clinical trial were randomly assigned into the acupressure group (n=35), which received acupressure at the true points, or the placebo group (n=35), which received acupressure at sham (false) points. Preoperative anxiety and vital signs before and after the intervention were measured in both groups. The findings demonstrated a reduction in the level of preoperative anxiety for both groups (Pacupressure group (Pacupressure at true points (third eye and Shen men) can reduce higher preoperative anxiety of patients before abdominal surgery and that it has had a more clinically beneficial effect than sham points.

  12. Effects of PBBs on cattle. I. Clinical evaluations and clinical chemistry.

    Science.gov (United States)

    Durst, H I; Willett, L B; Schanbacher, F L; Moorhead, P D

    1978-04-01

    Toxicosis was induced in pregnant heifers by feeding 25,000 mg/head/day of FireMaster BP-6, a commercial blend of polybrominated biphenyls (PBB). The PBB feeding decreased dry matter intake approximately 50% by 4 days exposure. Emaciated animals became anorexic a few days prior to death at 33 to 66 days. Weight losses of heifers average 80 kg. Other clinical signs observed were dehydration, diarrhea, excessive salivation and lacrimation, fetal death, abortion, and general depression as evidenced by depressed heart and respiratory rates. Clinical signs were apparent after 10 days exposure and progressively intensified along with loss of condition until death. Clinicopathologic changes included significantly increased serum glutamic-oxaloacetic transaminase and decreased serum calcium by 30 days exposure. Lactate dehydrogenase, urea nitrogen, and bilirubin were elevated, and serum albumin decreased by 36 to 40 days. Principal urine changes were decreased specific gravity and moderate proteinuria. Pregnant heifers fed 0.25 or 250 mg/head/day for 60 days and nonpregnant heifers fed 250 mg/head/day for 180 days displayed neither clinical signs nor clinicopathologic changes indicating adverse effects from PBB exposure. Post-exposure, all heifers exposed to PBB for 60 days calved normally with zero calf mortality and were successfully rebred. Milk production was not different from control animals. Birth weights of calves from dams exposed to 250 mg PBB/head/day were significantly greater than calves of dams exposed to 0 mg or 0.25 mg/head/day. PBB exposure of dams produced no detrimental effects on calves as indicated by clinical signs, clinicopathologic changes, or performance.

  13. Developing an instrument to measure effective factors on clinical learning

    Directory of Open Access Journals (Sweden)

    IDEH DADGARAN

    2016-07-01

    Full Text Available Introduction: Although nursing students spend a large part of their learning period in the clinical environment, clinical learning has not been perceived by its nature yet. To develop an instrument to measure effective factors on clinical learning in nursing students. Methods: This is a mixed methods study performed in 2 steps. First, the researchers defined “clinical learning” in nursing students through qualitative content analysis and designed items of the questionnaire based on semi-structured individual interviews with nursing students. Then, as the second step, psychometric properties of the questionnaire were evaluated using the face validity, content validity, construct validity, and internal consistency evaluated on 227 students from fourth or higher semesters. All the interviews were recorded and transcribed, and then, they were analyzed using Max Qualitative Data Analysis and all of qualitative data were analyzed using SPSS 14. Results: To do the study, we constructed the preliminary questionnaire containing 102 expressions. After determination of face and content validities by qualitative and quantitative approaches, the expressions of the questionnaire were reduced to 45. To determine the construct validity, exploratory factor analysis was applied. The results indicated that the maximum variance percentage (40.55% was defined by the first 3 factors while the rest of the total variance percentage (59.45% was determined by the other 42 factors. Results of exploratory factor analysis of this questionnaire indicated the presence of 3 instructor-staff, students, and educational related factors. Finally, 41 expressions were kept in 3 factor groups. The α-Cronbach coefficient (0.93 confirmed the high internal consistency of the questionnaire. Conclusion: Results indicated that the prepared questionnaire was an efficient instrument in the study of the effective factors on clinical learning as viewed by nursing students since it

  14. Clinical features of hereditary spastic paraplegia with thin corpus callosum:report of 5 Chinese cases

    Institute of Scientific and Technical Information of China (English)

    唐北沙; 陈昕; 赵国华; 沈璐; 严新翔; 江泓; 罗巍

    2004-01-01

    Background Hereditary spastic paraplegia is a clinically and genetically heterogeneous group of neurodegenerative disorders of the motor system, characterized by slowly progressive spasticity and weakness of the lower extremities. This study was conducted to investigate the clinical features of hereditary spastic paraplegia with thin corpus callosum (HSP-TCC). Methods Clinical data from five patients and thirty-five previously published case reports of HSP-TCC were analyzed retrospectively. Results Most patients were adolescents at the onset of the disease, presenting with spastic paraparesis of the lower limbs and mental impairment. Some patients also had other clinical features, including spasticity of the upper limbs, cerebellar ataxia, and sensory disturbances. Cranial MRIs of the five patients revealed an extremely thin corpus callosum, sometimes with widened cerebral sulci and ventricles, as well as with cerebellar and cerebral atrophy. Conclusion The main clinical features of HSP-TCC include slowly progressive spastic paraplegia, mental impairment during the second decade of life, and an extremely thin corpus callosum as shown on cranial MRIs.

  15. CyberKnife for hilar lung tumors: report of clinical response and toxicity

    Directory of Open Access Journals (Sweden)

    Collins Sean P

    2010-10-01

    Full Text Available Abstract Objective To report clinical efficacy and toxicity of fractionated CyberKnife radiosurgery for the treatment of hilar lung tumors. Methods Patients presenting with primary and metastatic hilar lung tumors, treated using the CyberKnife system with Synchrony fiducial tracking technology, were retrospectively reviewed. Hilar location was defined as abutting or invading a mainstem bronchus. Fiducial markers were implanted by conventional bronchoscopy within or adjacent to tumors to serve as targeting references. A prescribed dose of 30 to 40 Gy to the gross tumor volume (GTV was delivered in 5 fractions. Clinical examination and PET/CT imaging were performed at 3 to 6-month follow-up intervals. Results Twenty patients were accrued over a 4 year period. Three had primary hilar lung tumors and 17 had hilar lung metastases. The median GTV was 73 cc (range 23-324 cc. The median dose to the GTV was 35 Gy (range, 30 - 40 Gy, delivered in 5 fractions over 5 to 8 days (median, 6 days. The resulting mean maximum point doses delivered to the esophagus and mainstem bronchus were 25 Gy (range, 11 - 39 Gy and 42 Gy (range, 30 - 49 Gy, respectively. Of the 17 evaluable patients with 3 - 6 month follow-up, 4 patients had a partial response and 13 patients had stable disease. AAT t a median follow-up of 10 months, the 1-year Kaplan-Meier local control and overall survival estimates were 63% and 54%, respectively. Toxicities included one patient experiencing grade II radiation esophagitis and one patient experiencing grade III radiation pneumonitis. One patient with gross endobronchial tumor within the mainstem bronchus developed a bronchial fistula and died after receiving a maximum bronchus dose of 49 Gy. Conclusion CyberKnife radiosurgery is an effective palliative treatment option for hilar lung tumors, but local control is poor at one year. Maximum point doses to critical structures may be used as a guide for limiting toxicities. Preliminary results

  16. Clinical-instrumental evaluation of the effects of mesoglycan sulphate in chronic vascular encephalopathy.

    Science.gov (United States)

    Orlandi, G; Viapiano, F; Massetani, R; Ferrari, M; Murri, L

    1991-06-01

    15 patients with chronic cerebrovascular disease were studied using carotid Doppler and B-mode echography, transcranial Doppler, EEG and clinical evaluation before and 3 and 6 months after treatment with mesoglycan sulphate at doses of 96 mg/day per os. A subjective improvement was reported by 7 out of 15 patients while no significant variations in Doppler, TCD, echographic and EEG data were observed. During treatment no side effects or laboratory abnormalities were found.

  17. Immediate fixed partial denture after tooth extraction in patients with systemic diseases: A clinical report

    Science.gov (United States)

    2016-01-01

    For patients with systemic diseases who face difficulties visiting dental clinics, wearing fixed partial denture in the anterior region on the same day of tooth extraction can reduce the total period of treatment and the number of visits, as well as post-treatment psychological effect on the patient. PMID:28018570

  18. Immediate fixed partial denture after tooth extraction in patients with systemic diseases: A clinical report

    OpenAIRE

    Kang, Hyun Sun; Lee, Su Young

    2016-01-01

    For patients with systemic diseases who face difficulties visiting dental clinics, wearing fixed partial denture in the anterior region on the same day of tooth extraction can reduce the total period of treatment and the number of visits, as well as post-treatment psychological effect on the patient.

  19. Immediate fixed partial denture after tooth extraction in patients with systemic diseases: A clinical report.

    Science.gov (United States)

    Kang, Hyun Sun; Lee, Su Young

    2016-12-01

    For patients with systemic diseases who face difficulties visiting dental clinics, wearing fixed partial denture in the anterior region on the same day of tooth extraction can reduce the total period of treatment and the number of visits, as well as post-treatment psychological effect on the patient.

  20. Ten tips for receiving feedback effectively in clinical practice.

    Science.gov (United States)

    Algiraigri, Ali H

    2014-01-01

    Despite being recognized as a fundamental part of the educational process and emphasized for several decades in medical education, the influence of the feedback process is still suboptimal. This may not be surprising, because the focus is primarily centered on only one half of the process - the teachers. The learners are the targets of the feedback process and improvement needs to be shifted. Learners need to be empowered with the skills needed to receive and utilize feedback and compensate for less than ideal feedback delivery due to the busy clinical environment. Based on the available feedback literature and clinical experience regarding feedback, the author developed 10 tips to empower learners with the necessary skills to seek, receive, and handle feedback effectively, regardless of how it is delivered. Although, most of the tips are directed at the individual clinical trainee, this model can be utilized by clinical educators involved in learner development and serve as a framework for educational workshops or curriculum. Ten practical tips are identified that specifically address the learner's role in the feedback process. These tips not only help the learner to ask, receive, and handle the feedback, but will also ease the process for the teachers. Collectively, these tips help to overcome most, if not all, of the barriers to feedback and bridge the gaps in busy clinical practices. Feedback is a crucial element in the educational process and it is shown that we are still behind in the optimal use of it; thus, learners need to be taught how to better receive and utilize feedback. The focus in medical education needs to balance the two sides of the feedback process. It is time now to invest on the learner's development of skills that can be utilized in a busy day-to-day clinical practice.

  1. Self-Reported Non-Celiac Wheat Sensitivity in High School Students: Demographic and Clinical Characteristics

    Directory of Open Access Journals (Sweden)

    Antonio Carroccio

    2017-07-01

    Full Text Available Background: Non-Celiac Wheat Sensitivity (NCWS has recently been included among the gluten-related disorders. As no biomarkers of this disease exist, its frequency has been estimated based on self-reported symptoms, but to date no data are available about self-reported NCWS in teenagers. Aim: To explore the prevalence of self-reported NCWS in a group of high school students and to study their demographic and clinical characteristics. Methods: The study was performed between April 2015 and January 2016 in two high schools of a coastal town in the south of Sicily (Italy. A total of 555 students (mean age 17 years, 191 male, 364 female completed a modified validated questionnaire for self-reported NCWS. The subjects who self-reported NCWS were then compared with all the others. Results: Seven individuals (1.26% had an established diagnosis of CD. The prevalence of self-reported NCWS was 12.2%, and 2.9% were following a gluten-free diet (GFD. Only 15 out of 68 (23% NCWS self-reporters had consulted a doctor for this problem and only nine (14% had undergone serological tests for celiac disease. The NCWS self-reporters very often had IBS symptoms (44%. Conclusions: Self-reported NCWS was found to be common in teenagers, with a frequency of 12.2%; the frequency of GFD use was 2.9%, which was much higher than the percentage of known CD in the same population (1.26%. A greater awareness of the possible implications on the part of the subjects involved, and a more thorough medical approach to the study of self-reported wheat-induced symptoms are required.

  2. Ethics reporting practices in clinical research publications: A review of four Indian journals

    Directory of Open Access Journals (Sweden)

    Mahesh N Belhekar

    2014-01-01

    Full Text Available Background: Manuscript authors of scientific journals are expected to report if their studies were conducted according to international and national ethical guidelines and inform readers regarding ethics approval and informed consent obtained from participants and/or their legally acceptable representative/s. In the present study we assessed the reporting practices of ethics approval and informed consent (assent in case of pediatric studies in four Indian journals. Materials and Methods: Original research articles published over a period of 4 years (2009-2012 in four major national clinical journals, viz. Journal of Association of Physicians of India (JAPI, Indian Journal of Surgery (IJS, Journal of Obstetrics and Gynecology of India (JOGI, and Indian Journal of Orthopedics (IJO were reviewed with regard to documentation of ethics approval and written informed consent and assent in case of pediatric participants. Results: We reviewed 673 research articles and found that, overall ethical approval was mentioned in 163 (24.2% and informed consent or assent was mentioned in 179 (26.5% articles in all four journals. Individually we found, in JAPI of the 174 manuscripts reviewed, 74 (42.5% reported having obtained approval from the ethics committee and 68 (39.1% reported taking written informed consent from participants. In IJS of 123 manuscripts, 18 (14.6% reported ethics committee approval and 20 (16.2% reported informed consent from participants. In JOGI of 152 manuscripts, 21 (13.8% reported ethics committee approval while 49 (32.2% reported informed consent from participants. In IJO, of 224 manuscripts, 50 (22.3% reported ethics committee approval and 42 (18.7% reported obtaining informed consent. Conclusion: Majority of the publications did not provide information regarding compliance to ethical guidelines in spite of the availability of various guidelines. Thus, there is a need for awareness and training on bioethics for authors, reviewers, and

  3. Orthodontic Clinical Trials III: reporting of ethical issues associated with clinical trials published in three orthodontic journals between 1989 and 1998.

    Science.gov (United States)

    Harrison, Jayne E

    2005-06-01

    The aims of this study were to assess whether reports of orthodontic clinical trials complied with the requirements of the Declaration of Helsinki. A retrospective observational study. The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), Journal of Orthodontics (formerly and up until 1999 known as the British Journal of Orthodontics, BJO) and European Journal of Orthodontics (EJO). Clinical trials published between 1989 and 1998. A hand search was performed to identify all clinical trials. Each trial report was assessed for inclusion of a statement that ethical approval and/or informed consent had been obtained. One-hundred-and-fifty-five papers were identified, of which 85 (54.8%) were reports of randomized controlled trials (RCTs) and 70 (45.2%) of controlled clinical trials (CCTs). 16.1% (25/155), of the trial reports stated that ethical approval had been obtained and a quarter (39/155, 25.1%) indicated that informed consent had been obtained. Most orthodontic clinical trial reports failed to state whether ethical approval and/or informed consent had been obtained. The reporting of the ethical issues associated with orthodontic clinical trials could be improved further not only by the instructions to authors in orthodontic journals stating the need for studies to comply with the Declaration of Helsinki, but also by Journal editors refusing to publish trials that do not comply.

  4. Needle thoracostomy: Clinical effectiveness is improved using a longer angiocatheter.

    Science.gov (United States)

    Aho, Johnathon M; Thiels, Cornelius A; El Khatib, Moustafa M; Ubl, Daniel S; Laan, Danuel V; Berns, Kathleen S; Habermann, Elizabeth B; Zietlow, Scott P; Zielinski, Martin D

    2016-02-01

    Decompression of tension physiology may be lifesaving, but significant doubts remain regarding ideal needle thoracostomy (NT) catheter length in the treatment of tension physiology. We aimed to demonstrate increased clinical effectiveness of longer NT angiocatheter (8 cm) compared with current Advanced Trauma Life Support recommendations of 5-cm NT length. This is a retrospective review of all adult trauma patients from 2003 to 2013 (age > 15 years) transported to a Level I trauma center. Patients underwent NT at the second intercostal space midclavicular line, either at the scene of injury, during transport (prehospital), or during initial hospital trauma resuscitation. Before March 2011, both prehospital and hospital trauma team NT equipment routinely had a 5-cm angiocatheter available. After March 2011, prehospital providers were provided an 8-cm angiocatheter. Effectiveness was defined as documented clinical improvement in respiratory, cardiovascular, or general clinical condition. There were 91 NTs performed on 70 patients (21 bilateral placements) either in the field (prehospital, n = 41) or as part of resuscitation in the hospital (hospital, n = 29). Effectiveness of NT was 48% until March 2011 (n = 24). NT effectiveness was significantly higher in the prehospital setting than in the hospital (68.3% success rate vs. 20.7%, p < 0.01). Patients who underwent NT using 8 cm compared with 5 cm were significantly more effective (83% vs. 41%, respectively, p = 0.01). No complications of NT were identified in either group. Eight-centimeter angiocatheters are more effective at chest decompression compared with currently recommended 5 cm at the second intercostal space midclavicular line. Therapeutic study, level IV.

  5. Clinical and biochemical responses after Gamma Knife surgery for a dopamine-secreting paraganglioma: case report.

    Science.gov (United States)

    Tuleasca, Constantin; Jaquet, Yves; Schweizer, Valerie; Negretti, Laura; Magaddino, Vera; Maeder, Philippe; Abid, Karim-Alexandre; Lhermitte, Benoit; Grouzmann, Eric; Levivier, Marc

    2016-01-01

    The efficacy of Gamma Knife surgery (GKS) in local tumor control of non-secreting paragangliomas (PGLs) has been fully described by previous studies. However, with regard to secreting PGL, only one previous case report exists advocating its efficacy at a biological level. The aims of this study were: 1) to evaluate the safety/efficacy of GKS in a dopamine-secreting PGL; 2) to investigate whether the biological concentrations of free methoxytyramine could be used as a marker of treatment efficacy during the follow-up. We describe the case of a 62-year-old man diagnosed with left PGL. He initially underwent complete surgical excision. Thirty months after, he developed recurrent biological and neuroradiological disease; the most sensitive biomarker for monitoring the disease, concentration of plasma free methoxytyramine, started to increase. GKS was performed at a maximal marginal dose of 16 Gy. During the following 30 months, concentration of free methoxytyramine gradually decreased from 0.14 nmol/l (2*URL) before GKS to 0.09 nmol/l, 6 months after GKS and 0.07 nmol/l at the last follow-up after GKS (1.1*URL), confirming the efficacy of the treatment. Additionally, at 30 months there was approximately 36.6% shrinkage from the initial target volume. The GKS treatment was safe and effective, this being confirmed clinically, neuroradiologically and biologically. The case illustrates the importance of laboratory tests taking into account methoxytyramine when analyzing biological samples to assess the biochemical activity of a PGL. In addition, the identification of methoxytyramine as a unique positive biomarker could designate it for the monitoring of tumor relapse after treatments, including Gamma Knife surgery.

  6. Economic evaluation of the impact of medication errors reported by U.S. clinical pharmacists.

    Science.gov (United States)

    Samp, Jennifer C; Touchette, Daniel R; Marinac, Jacqueline S; Kuo, Grace M

    2014-01-01

    Medication errors defined as "any preventable event that may cause or lead to inappropriate medication use or patient harm" have been highlighted as a top national priority in a report issued by the Institute of Medicine. However, little information is available on precise costs of medication errors. This study estimated the cost of medication errors reported by clinical pharmacists using a modified societal perspective. Information on 779 medication errors was collected in the Medication Error Detection, Amelioration and Prevention (MEDAP) study that documented medication errors observed by clinical pharmacists during a consecutive 14-day period. The rate of medication errors, outcomes (number of errors resulting in temporary/permanent patient harm, prolonged hospitalization, or life-sustaining therapy), and interventions (communication, medication changes, patient monitoring, and treatment referrals) were collected. A decision model was developed to estimate the economic impact of medication errors reported by clinical pharmacists. Event probabilities were derived from MEDAP data. Direct costs were obtained through reviews of the literature, hospital charge data, and Medicare and Medicaid reimbursement. One-way and Monte Carlo sensitivity analyses were used to explore uncertainty in the values. In the base case, the mean expected cost of a medication error was $88.57. In the Monte Carlo simulation, the mean cost was $89.35 (± $30.17 SD). One-way sensitivity analysis revealed that changes in the probability of medication errors causing hospitalization and the cost of hospitalization had the greatest variability on the outcome ($50.44-$155.81 [probability of hospitalization], $32.59-$136.40 [cost of hospitalization]). Medication errors are costly to the health care system. A better understanding of medication error costs may be used to justify initiatives to reduce the risk and inefficiency associated with these errors. © 2013 American College of Clinical

  7. Clinical trials in orthodontics II: assessment of the quality of reporting of clinical trials published in three orthodontic journals between 1989 and 1998.

    Science.gov (United States)

    Harrison, J E

    2003-12-01

    To test the hypothesis that the quality of reporting of orthodontic clinical trials is insufficient to allow readers to assess the validity of the trial. A retrospective observational study. The American Journal of Orthodontics and Dentofacial Orthopedics (AJODO), the British Journal of Orthodontics (BJO) and European Journal of Orthodontics (EJO). Clinical trials published between 1989 and 1998. A hand search was performed to identify all clinical trials. The concealment of allocation, whether the trial was randomized, double blind, and whether there was a description of withdrawals and dropouts was recorded. One hundred and fifty-five trial reports were identified of which 4 (2.6%) were adequately concealed, 85 (54.8%) were described as being randomized, 10 (6.5%) as double-blind, and 44 (28.4%) gave a description of withdrawals and drop-outs from the trial. The type of randomization was considered appropriate in 78 (50.3%) reports and in 57 (36.8%) reports the level of blinding was considered appropriate. When assessed for the risk of bias in the reported trials,(1) one trial (0.6%) had a low risk of bias, 17 (11%) a moderate risk, and 137 (88.4%) a high risk. In general the quality of reporting orthodontic clinical trials was insufficient to allow readers to assess the validity of the trials. Reporting of clinical trials could be improved by orthodontic journals adopting the CONSORT statement(2,)(3) to ensure that all relevant information is provided.

  8. Clinical effect of venlafaxine combined with methylphenidate hydrochloride on narcolepsy

    Directory of Open Access Journals (Sweden)

    YAN Bin

    2013-11-01

    Full Text Available This study aims to explore the clinical effect of venlafaxine sustained-release capsules combined with methylphenidate hydrochloride tablets on narcolepsy. Thirty-eight cases of narcoleptic patients were randomly divided into venlafaxine combined with methylphenidate hydrochloride treatment group (observation group, N = 19 and methylphenidate hydrochloride and clomipramine treatment group (control group, N = 19. After a total of 12-week treatment, clinical curative effect and adverse drug reactions were observed in 2 groups of patients. The results showed that effective rate of the treatment for excessive daytime sleepiness (EDS in observation group was higher than that of the control group (15/19 vs 8/19, P = 0.044, and effective rate of the treatment for cataplexy in observation group was higher than that of the control group (13/19 vs 6/19, P = 0.048. The rate of adverse drug reactions in observation group was lower than that in the control group (χ2 = 8.889, P = 0.003. It was indicated that venlafaxine combined with methylphenidate had good curative effect on narcolepsy with EDS and cataplexy symptoms.

  9. Clinical and laboratory diagnosis of congenital Zika virus syndrome and diaphragmatic unilateral palsy: case report

    Directory of Open Access Journals (Sweden)

    Alex Sandro Rolland Souza

    Full Text Available Abstract Introduction: several birth defects associated to congenital Zika virus infection have been reported, although the clinical features have not been fully characterized. Description: this is the first case report on unilateral diaphragmatic paralysis diagnosed on a neonate with congenital Zika confirmed by the examination of the amniotic fluid through polymerase chain reaction (ZIKV RT-PCR and the examination of cerebrospinal fluid by serological test (IgM ZIKV-ELISA after birth. The main manifestations detected by intrauterine ultrasound were: microcephaly, ventriculomegaly, intracranial calcifications, enlarged cisterna magna, increased amniotic fluid index and fetal akinesia syndrome. The newborn had acute respiratory failure in the first hours of life, requiring mechanical ventila-tion. The X- ray of the chest showed unilateral diaphragmatic paralysis and cardiomegaly. Discussion: diaphragmatic palsy in congenital Zika has not been previously reported, the etiopathogenic mechanisms of this event in congenital Zika virus needs to be elucidated.

  10. In situ simulation: Taking reported critical incidents and adverse events back to the clinic

    DEFF Research Database (Denmark)

    Juul, Jonas; Paltved, Charlotte; Krogh, Kristian

    2014-01-01

    does not tap into situational resources, e.g. individual, team, and organisational characteristics such as routines, personal relations, distributed skill-levels etc. Therefore, it fails to fully mimic real clinical team processes. Alternatively, in situ simulation offers a unique opportunity...... improve patient safety if coupled with training and organisational support2. Insight into the nature of reported critical incidents and adverse events can be used in writing in situ simulation scenarios and thus lead to interventions that enhance patient safety. The patient safety literature emphasises...... well-developed non-technical skills in preventing medical errors3. Furthermore, critical incidents and adverse events reporting systems comprise a knowledgebase to gain in-depth insights into patient safety issues. This study explores the use of critical incidents and adverse events reports to inform...

  11. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    A R Pradeep

    2012-01-01

    Full Text Available Background: The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF as the active ingredient on gingivitis. Materials and Methods: Ninety subjects diagnosed with chronic generalized gingivitis were selected and randomly divided in three groups: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. Results: AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. Conclusions: AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  12. Clinical and microbiological effects of commercially available dentifrice containing amine fluoride: A randomized controlled clinical trial.

    Science.gov (United States)

    Pradeep, A R; Agarwal, Esha; Bajaj, Pavan; Naik, Savitha B; Kumari, Minal; Guruprasad, C N

    2012-07-01

    The inability of the normal adult population to perform adequate tooth brushing has led to the search for chemotherapeutic agents in order to improve plaque control. This 6 month, single center, randomized controlled clinical trial was conducted to assess the clinical and microbiological effects of a dentifrice containing only amine fluoride (AF) as the active ingredient on gingivitis. NINETY SUBJECTS DIAGNOSED WITH CHRONIC GENERALIZED GINGIVITIS WERE SELECTED AND RANDOMLY DIVIDED IN THREE GROUPS: Group 1 - placebo toothpaste, Group 2 - AF containing toothpaste, and Group 3 - triclosan containing toothpaste with polymer and fluoride. Clinical evaluation was undertaken using the gingival index of Loe and Silness and the plaque index and microbiological counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by a questionnaire. AF containing toothpaste showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to triclosan containing toothpaste. AF containing toothpaste may be a useful formulation for chemical plaque control agent and improvement in plaque and gingival status and add to the list of various therapeutic agents used for maintenance of gingival health.

  13. Distribution of cow-calf producers' beliefs about reporting cattle with clinical signs of foot-and-mouth disease to a veterinarian before or during a hypothetical outbreak.

    Science.gov (United States)

    Delgado, Amy H; Norby, Bo; Scott, H Morgan; Dean, Wesley; McIntosh, W Alex; Bush, Eric

    2014-12-01

    Understanding the prevalence of cattle producers' beliefs regarding disease reporting can help officials improve surveillance programs with passive data collection. A cross-sectional survey was conducted in Texas in 2008 and 2009 to determine beliefs about reporting cattle with clinical signs consistent with foot-and-mouth disease (FMD) either prior to (scenario 1) or during an on-going outbreak of FMD (scenario 2). Two questionnaires were developed and distributed to Texas cow-calf producers in order to evaluate their behavioral, control, and normative beliefs related to disease reporting. The context for each behavior was provided through the use of scenarios, and belief strength was measured using a 7-point Likert-like scale. Beliefs were compared across scenarios and demographic categories, and the effect of scenario on belief examined using ordinal logistic regression. Respondents agreed that reporting clinically suspect cases would have positive economic and emotional consequences; however, when an outbreak was known to be present, producers were less likely to agree with many of the positive outcomes of reporting. Important barriers to disease reporting indicated by producers included a lack of knowledge related to clinical signs of highly contagious cattle diseases and which cattle are at risk of contracting FMD. In general, beliefs about barriers to reporting did not differ based on scenario. Veterinarians and regulatory authorities were the groups perceived to most strongly expect disease reporting, regardless of the scenario. Risk education for producers related to clinical signs of reportable livestock diseases, post-reporting procedures, and an understanding of FMD introduction and spread may improve the reporting of cattle with clinical signs consistent with FMD. Published by Elsevier B.V.

  14. Sildenafil (Viagra for male erectile dysfunction: a meta-analysis of clinical trial reports

    Directory of Open Access Journals (Sweden)

    McQuay HJ

    2002-05-01

    Full Text Available Abstract Background Evaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology. Methods Clinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home. Results Ten randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo. NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3. For global improvement in erections the NNT was 1.7 (1.6 to 1.9. Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3. All cause discontinuations were less frequent with sildenafil (10% than with placebo (20%. Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses. Conclusion This review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.

  15. [Metaanalysis to estimate the expected drop out-rates reported in clinical trials on cataract surgery].

    Science.gov (United States)

    Knippschild, S; Hirsch, J; Krummenauer, F

    2014-02-01

    A realistic sample size calculation is crucial to achieve significant results in clinical trials. As an expected drop out-rate has to be included in the sample size calculation, current practice consists in the presumption of drop out-rates published in previous similar investigations. This approach may, however, result in severely over- or under-estimated sample sizes. Therefore this meta-analysis sought to aggregate the drop out-rates from published clinical trial reports on cataract surgery to derive a quantitative suggestion for the planning of future clinical trials. The data collection was a complete review of all prospective and retrospective studies in five journals of the years 2002-2012; trial-wise recall rates of subjects at follow-up 3, 6, 12, and 24 months after recruitment were documented. The primary endpoint of the meta-analysis was the reported drop out-rates after 6 months. 95 % confidence intervals were calculated for each trial, respectively; a median drop out-rate was estimated including its 95 % confidence interval. The drop-out-rate estimates were furthermore stratified by design characteristics of the reported studies. For randomised clinical trials on cataract surgery, the median drop out-rate increased during the follow-up period of 24 months from 4 % at three months to 17 % at 24 months after recruitment; for the six-month drop out-rate a median drop-out rate of 3 % (95 % CI 0 %; 14 %) was estimated. Drop out-rates in sample size calculations for clinical trials on cataract surgery were found to be over-estimated in general, ending up in the calculation of overly large patient numbers and thereby in both ethical and economic consequences. For randomised clinical trials on cataract surgery the median drop out-rate can be expected to be 5 % during a six-month follow-up and may rise up to 15 % during a 12-month trial period. Georg Thieme Verlag KG Stuttgart · New York.

  16. Subgroup analyses of clinical effectiveness to support health technology assessments.

    Science.gov (United States)

    Paget, Marie-Ange; Chuang-Stein, Christy; Fletcher, Christine; Reid, Carol

    2011-01-01

    Subgroup analysis is an integral part of access and reimbursement dossiers, in particular health technology assessment (HTA), and their HTA recommendations are often limited to subpopulations. HTA recommendations for subpopulations are not always clear and without controversies. In this paper, we review several HTA guidelines regarding subgroup analyses. We describe good statistical principles for subgroup analyses of clinical effectiveness to support HTAs and include case examples where HTA recommendations were given to subpopulations only. Unlike regulatory submissions, pharmaceutical statisticians in most companies have had limited involvement in the planning, design and preparation of HTA/payers submissions. We hope to change this by highlighting how pharmaceutical statisticians should contribute to payers' submissions. This includes early engagement in reimbursement strategy discussions to influence the design, analysis and interpretation of phase III randomized clinical trials as well as meta-analyses/network meta-analyses. The focus on this paper is on subgroup analyses relating to clinical effectiveness as we believe this is the first key step of statistical involvement and influence in the preparation of HTA and reimbursement submissions.

  17. Management of Patient-Reported Outcome (PRO Alerts in Clinical Trials: A Cross Sectional Survey.

    Directory of Open Access Journals (Sweden)

    Derek Kyte

    Full Text Available Assessment of patient-reported outcomes (PROs provides valuable information to inform patient-centered care, but may also reveal 'PRO alerts': psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint.We conducted a national cross-sectional survey of 767 UK-based research nurses, data managers/coordinators, trial managers and chief/principal investigators involved in clinical trials using PROs. Respondents were self-selected volunteers from a non-randomised sample of eligible individuals recruited via 55 UK Clinical Research Collaboration Registered Clinical Trials Units and 19 Comprehensive Local Research Networks. Questions centred on the proportion of trial personnel encountering alerts, how staff responded to PRO alerts and whether current guidance was deemed sufficient to support research personnel. We undertook descriptive analyses of the quantitative data and directed thematic analysis of free-text comments. 20% of research nurses did not view completed PRO questionnaires and were not in a position to discover alerts, 39-50% of the remaining respondent group participants reported encountering PRO alerts. Of these, 83% of research nurses and 54% of data managers/trial coordinators reported taking action to assist the trial participant, but less than half were able to record the intervention in the trial documentation. Research personnel reported current PRO alert guidance/training was insufficient.Research personnel are intermittently exposed to PRO alerts. Some intervene to help trial participants, but are not able to record this intervention in the trial documentation, risking co-intervention bias. Other staff do not check PRO

  18. Communicating clinical trial outcomes: Effects of presentation method on physicians' evaluations of new treatments

    Directory of Open Access Journals (Sweden)

    Francesco Marcatto

    2013-01-01

    Full Text Available Physicians expect a treatment to be more effective when its clinical outcomes are described as relative rather than as absolute risk reductions. We examined whether effects of presentation method (relative vs. absolute risk reduction remain when physicians are provided the baseline risk information, a vital piece of statistical information omitted in previous studies. Using a between-subjects design, ninety five physicians were presented the risk reduction associated with a fictitious treatment for hypertension either as an absolute risk reduction or as a relative risk reduction, with or without including baseline risk information. Physicians reported that the treatment would be more effective and that they would be more willing to prescribe it when its risk reduction was presented to them in relative rather than in absolute terms. The relative risk reduction was perceived as more effective than absolute risk reduction even when the baseline risk information was explicitly reported. We recommend that information about absolute risk reduction be made available to physicians in the reporting of clinical outcomes. Moreover, health professionals should be cognizant of the potential biasing effects of risk information presented in relative risk terms.

  19. Look Local: The Value of Cancer Surveillance and Reporting by American Indian Clinics

    Science.gov (United States)

    Creswell, Paul D.; Stephenson, Laura; Pierce-Hudson, Kimmine; Matloub, Jacqueline; Waukau, Jerry; Adams, Alexandra; Kaur, Judith; Remington, Patrick L.

    2013-01-01

    Introduction Cancer incidence and mortality rates for American Indians in the Northern Plains region of the United States are among the highest in the nation. Reliable cancer surveillance data are essential to help reduce this burden; however, racial data in state cancer registries are often misclassified, and cases are often underreported. Methods We used a community-based participatory research approach to conduct a retrospective ascertainment of cancer cases in clinic medical records over a 9-year period (1995–2003) and compared the results with the state cancer registry to evaluate missing or racially misclassified cases. Six tribal and/or urban Indian clinics participated in the study. The project team consisted of participating clinics, a state cancer registry, a comprehensive cancer center, an American Indian/Alaska Native Leadership Initiative on Cancer, and a set of diverse organizational partners. Clinic personnel were trained by project staff to accurately identify cancer cases in clinic records. These records were then matched with the state cancer registry to assess misclassification and underreporting. Results Forty American Indian cases were identified that were either missing or misclassified in the state registry. Adding these cases to the registry increased the number of American Indian cases by 21.3% during the study period (P = .05). Conclusions Our results indicate that direct reporting of cancer cases by tribal and urban Indian health clinics to a state cancer registry improved the quality of the data available for cancer surveillance. Higher-quality data can advance the efforts of cancer prevention and control stakeholders to address disparities in Native communities. PMID:24286271

  20. Improving clinical cognitive testing: report of the AAN Behavioral Neurology Section Workgroup.

    Science.gov (United States)

    Daffner, Kirk R; Gale, Seth A; Barrett, A M; Boeve, Bradley F; Chatterjee, Anjan; Coslett, H Branch; D'Esposito, Mark; Finney, Glen R; Gitelman, Darren R; Hart, John J; Lerner, Alan J; Meador, Kimford J; Pietras, Alison C; Voeller, Kytja S; Kaufer, Daniel I

    2015-09-08

    To evaluate the evidence basis of single-domain cognitive tests frequently used by behavioral neurologists in an effort to improve the quality of clinical cognitive assessment. Behavioral Neurology Section members of the American Academy of Neurology were surveyed about how they conduct clinical cognitive testing, with a particular focus on the Neurobehavioral Status Exam (NBSE). In contrast to general screening cognitive tests, an NBSE consists of tests of individual cognitive domains (e.g., memory or language) that provide a more comprehensive diagnostic assessment. Workgroups for each of 5 cognitive domains (attention, executive function, memory, language, and spatial cognition) conducted evidence-based reviews of frequently used tests. Reviews focused on suitability for office-based clinical practice, including test administration time, accessibility of normative data, disease populations studied, and availability in the public domain. Demographic and clinical practice data were obtained from 200 respondents who reported using a wide range of cognitive tests. Based on survey data and ancillary information, between 5 and 15 tests in each cognitive domain were reviewed. Within each domain, several tests are highlighted as being well-suited for an NBSE. We identified frequently used single-domain cognitive tests that are suitable for an NBSE to help make informed choices about clinical cognitive assessment. Some frequently used tests have limited normative data or have not been well-studied in common neurologic disorders. Utilizing standardized cognitive tests, particularly those with normative data based on the individual's age and educational level, can enhance the rigor and utility of clinical cognitive assessment. © 2015 American Academy of Neurology.

  1. Pathological and Clinical Correlation between Celiac Disease and Helicobacter Pylori Infection; a Review of Controversial Reports.

    Science.gov (United States)

    Rostami-Nejad, Mohammad; Javad Ehsani-Ardakani, Mohammad; Assadzadeh, Hamid; Shahbazkhani, Bijan; Ierardi, Enzo; Losurdo, Giuseppe; Zojaji, Homayon; Alizadeh, Amirhoshang Mohammad; Naderi, Nosratollah; Sadeghi, Amir; Zali, Mohammad Reza

    2016-04-01

    There are overwhelming reports and descriptions about celiac associated disorders. Although there is a clear genetic association between celiac disease (CD) and some gastrointestinal disorders, there are controversial reports claiming an association between CD and Helicobacter pylori (H. pylori) infection. Different studies indicated the possible association between lymphocytic gastritis and both CD and H. pylori infection, although this evidence is not consistently accepted. Also it was shown that an increase in intraepithelial lymphocytes count is associated with both H. pylori infection and celiac disease. Therefore the following questions may raise: how far is this infection actually related to CD?, which are the underlying patho-mechanisms for these associations? what are the clinical implications? what is the management? and what would be the role of gluten free diet in treating these conditions? PubMed (PubMed Central), Ovid, ISI of web knowledge, and Google scholar were searched for full text articles published between 1985 and 2015. The associated keywords were used, and papers described particularly the impact of pathological and clinical correlation between CD and H. pylori infection were identified. In this review we tried to answer the above questions and discussed some of the recent developments in the pathological and clinical aspects of CD and H. pylori infection.

  2. The 7q11.23 Microduplication Syndrome: A Clinical Report with Review of Literature.

    Science.gov (United States)

    Abbas, Elham; Cox, Devin M; Smith, Teri; Butler, Merlin G

    2016-09-01

    We report a 14-year-old adolescent girl with selective mutism (SM) and a 7q11.23 microduplication detected by chromosomal microarray (CMA) analysis and reviewed the literature from 18 published clinical reports. Our patient had specific phobias, SM, extreme anxiety, obesity, cutis marmorata, and a round appearing face with a short neck and over folded ears. We reviewed the published clinical, cognitive, behavioral, and cytogenetic findings grouped by speech and language delay, growth and development, craniofacial, clinical, and behavior and cognitive features due to the 7q11.23 microduplication. This microduplication syndrome is characterized by speech delay (91%), social anxiety (42%), attention deficit hyperactivity disorder (ADHD, 37%), autism spectrum disorder (29%), and separation anxiety (13%). Other findings include abnormal brain imaging (80%), congenital heart and vascular defects (54%), and mild intellectual disability (38%). We then compared the phenotype with Williams-Beuren syndrome (WBS) which is due to a deletion of the same chromosome region. Both syndromes have abnormal brain imaging, hypotonia, delayed motor development, joint laxity, mild intellectual disability, ADHD, autism, and poor visuospatial skills but opposite or dissimilar findings regarding speech and behavioral patterns, cardiovascular problems, and social interaction. Those with WBS are prone to have hyperverbal speech, lack of stranger anxiety, and supravalvular aortic stenosis while those with the 7q11.23 microduplication have speech delay, SM, social anxiety, and are prone to aortic dilatation.

  3. Clinical report on and CT findings in two siblings with bilateral striatal necrosis

    Energy Technology Data Exchange (ETDEWEB)

    Maya, Kiyomi; Imai, Terukuni; Hashimoto, Shuji; Yamasaki, Masahiro (Kitano Hospital, Osaka (Japan)); Kajiura, Ichiro

    1983-12-01

    Two siblings, a 13-year-old girl and a 9-year-old boy, presented a similar progressive extrapyramidal disorder. The onsets were at the age of 4 years and at that of 2 1/2 years respectively, and a certain febrile illness had preceded it for two or three months in both cases. The major clinical features were progressive gait disturbance, dysarthria, and dystonia; they were associated with secondary skeletal deformities in the sister and with abnormal ocular movements in the brother. The CT findings, essentially similar in both cases, were characterized by symmetrical hypodensity lesions and an atrophy of the corpora striata, namely, the putamen and the caudate nucleus. Based on the clinical features and the CT findings, and on a comparison with the previous clinico-pathological reports in the literature, the present cases were diagnosed as bilateral striatal necrosis. The disorder termed ''bilateral striatal necrosis'' has not been widely known; this report stresses the great usefulness of CT examination in the clinical diagnosis of this rare disorder.

  4. Ovarian hyperstimulation syndrome: review and new classification criteria for reporting in clinical trials.

    Science.gov (United States)

    Humaidan, P; Nelson, S M; Devroey, P; Coddington, C C; Schwartz, L B; Gordon, K; Frattarelli, J L; Tarlatzis, B C; Fatemi, H M; Lutjen, P; Stegmann, B J

    2016-09-01

    What is an objective approach that employs measurable and reproducible physiologic changes as the basis for the classification of ovarian hyperstimulation syndrome (OHSS) in order to facilitate more accurate reporting of incidence rates within and across clinical trials? The OHSS flow diagram is an objective approach that will facilitate consistent capture, classification and reporting of OHSS within and across clinical trials. OHSS is a potentially life-threatening iatrogenic complication of the early luteal phase and/or early pregnancy after ovulation induction (OI) or ovarian stimulation (OS). The clinical picture of OHSS (the constellation of symptoms associated with each stage of the disease) is highly variable, hampering its appropriate classification in clinical trials. Although some degree of ovarian hyperstimulation is normal after stimulation, the point at which symptoms transition from those anticipated to those of a disease state is nebulous. An OHSS working group, comprised of subject matter experts and clinical researchers who have significantly contributed to the field of fertility, was convened in April and November 2014. The OHSS working group was tasked with reaching a consensus on the definition and the classification of OHSS for reporting in clinical trials. The group engaged in targeted discussion regarding the scientific background of OHSS, the criteria proposed for the definition and the rationale for universal adoption. An agreement was reached after discussion with all members. One of the following conditions must be met prior to making the diagnosis of OHSS in the context of a clinical trial: (i) the subject has undergone OS (either controlled OS or OI) AND has received a trigger shot for final oocyte maturation (e.g. hCG, GnRH agonist [GnRHa] or kisspeptin) followed by either fresh transfer or segmentation (cryopreservation of embryos) or (ii) the subject has undergone OS or OI AND has a positive pregnancy test. All study patients who

  5. The quality of the evidence base for clinical pathway effectiveness: Room for improvement in the design of evaluation trials

    NARCIS (Netherlands)

    T. Rotter (Thomas); L. Kinsman (Leigh); E. James (Erica); A. Machotta (Andreas); E.W. Steyerberg (Ewout)

    2012-01-01

    textabstractBackground: The purpose of this article is to report on the quality of the existing evidence base regarding the effectiveness of clinical pathway (CPW) research in the hospital setting. The analysis is based on a recently published Cochrane review of the effectiveness of CPWs. Methods: A

  6. Pop-cola acids and tooth erosion: an in vitro, in vivo, electron-microscopic, and clinical report.

    Science.gov (United States)

    Borjian, Amirfirooz; Ferrari, Claudia C F; Anouf, Antoni; Touyz, Louis Z G

    2010-01-01

    Introduction. Manufactured Colas are consumed universally as soft drinks. Evidence about the acid contents of Cola-beverages and its effects on teeth is rare. Aim. To assess (i) cola acidity and buffering capacity in vitro, (ii) tooth erosion after swishing with colas in vivo (iii) scanning electron microscopic effects on teeth of colas, and tooth-brush abrasion, and (iv) report a clinical case of erosion from cola consumption. Materials and Methods. (i) We measured six commercially available pop "Cola beverages", pH, and buffering capacities using a pH-Mettler Automatic Titrator, with weak solution of Sodium Hydroxide (ii) two cohorts, one with teeth, the second without teeth rinsed with aliquots of Cola for 60 seconds. Swished cola samples tested for calcium and phosphorus contents using standardized chemical analytical methods (iii) enamel, dentine, and the enamel-cemental junction from unerupted extracted wisdom teeth were examined with a scanning electron microscope after exposure to colas, and tested for tooth-brush abrasion; (iv) a clinical case of pop cola erosion presentation, are all described. Results. Comparisons among pop colas tested in vitro reveal high acidity with very low pH. Buffering capacities in millilitres of 0.5 M NaOH needed to increase one pH unit, to pH 5.5 and pH 7 are reported. Rinsing in vivo with pop cola causes leeching of calcium from teeth; SEM shows dental erosion, and pop-cola consumption induces advanced dental erosion and facilitates abrasion. Conclusions. (i) Pop-Cola acid activity is below the critical pH 5.5 for tooth dissolution, with high buffering capacities countering neutralization effects of saliva; (ii) calcium is leeched out of teeth after rinsing with pop colas; (iii) SEM evidence explains why chronic exposure to acid pop colas causes dental frangibles; (iv) a clinical case of pop-cola erosion confirms this.

  7. Minimal Clinically Important Difference of Patient Reported Outcome Measures of Lower Extremity Injuries in Orthopedics

    Science.gov (United States)

    Çelik, Derya; Çoban, Özge; Kılıçoğlu, Önder

    2017-01-01

    Purpose: MCID scores for outcome measures are frequently used evidence-based guides to gage meaningful changes. To conduct a systematic review of the quality and content of the the minimal clinically important difference (MCID) relating to 16 patient-rated outcome measures (PROM) used in lower extremity. Methods: We conducted a systematic literature review on articles reporting MCID in lower extremity outcome measures and orthopedics from January 1, 1980, to May 10, 2016. We evaluated MCID of the 16 patient reported outcome measures (PROM) which were Harris Hip Score (HHS), Oxford Hip Score (OHS), Hip Outcome Score (HOS), Hip Disability and Osteoarthritis Outcome Score (HOOS), The International Knee Documentation Committee Subjective Knee Form (IKDC), The Lysholm Scale, The Western Ontario Meniscal Evaluation Tool (WOMET), The Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QOL), The Lower Extremity Functional Scale (LEFS), The Western Ontario and Mcmaster Universities Index (WOMAC), Knee İnjury And Osteoarthritis Outcome Score (KOOS), Oxford Knee Score (OKS), Kujala Anterior Knee Pain Scale, The Victorian Institute of Sports Assessment Patellar Tendinosis (Jumper’s Knee) (VİSA-P), Tegner Activity Rating Scale, Marx Activity Rating Scale, Foot And Ankle Outcome Score (FAOS), The Foot Function Index (FFI), Foot And Ankle Ability Measure (FAAM), The Foot And Ankle Disability Index Score and Sports Module, Achill Tendon Total Rupture Score(ATRS), The Victorian İnstitute Of Sports Assesment Achilles Questionnaire(VİSA-A), American Orthopaedic Foot and Ankle Society (AOFAS). A search of the PubMed/MEDLINE, PEDro and Cochrane Cen¬tral Register of Controlled Trials and Web of Science databases from the date of inception to May 1, 2016 was conducted. The terms “minimal clinically important difference,” “minimal clinically important change”, “minimal clinically important improvement” “were combined with one of the PROM as mentioned above

  8. An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

    Science.gov (United States)

    Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

    2014-05-01

    Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

  9. Management of Ano-Rectal disorders by Kṣārasūtra: A clinical report

    Directory of Open Access Journals (Sweden)

    Vijaya Kumari Kurapati

    2014-01-01

    Full Text Available Background: Ano-rectal complaints are usually benign in origin. Most of the patients suffering with these disorders do not seek medical advice at an early stage due to embarrassment. It results in advancement of the disease and significant disturbance in the quality of life. Among the available treatment modalities of ano-rectal disorders (ARDs, Kṣārasūtra (medicated thread appears to be the best in terms of relief and nonrecurrence. Aims and Objectives: The aim of this study is to provide evidence-based data about the practical application of Kṣārasūtra (medicated thread in the management of ARDs. Materials and Methods: An ano-rectal operation theatre was established in September 2012, in association with the Government Ayurvedic Speciality Clinic at District Hospital, Rajahmundry, Andhra Pradesh, to facilitate the AYUSH services in Allopathic Hospitals. Present report includes the details of ARDs treated by Kṣārasūtra (Medicated thread method during 2012-2013. A total of 127 ano-rectal cases were operated, which included 44 cases of hemorrhoids, 40 cases of fistula-in-ano, 39 cases of fissure-in-ano and three cases of peri-anal abscess. All the cases were analyzed as per the observations, subjective and objective parameters, and follow-up was carried out for a period of 6 months. Results: In the 127 ARDs treated, 45 patients suffering from hemorrhoids, 36 patients got complete relief, marked relief observed in 4 patients, moderate relief observed in 5 patients. In fistula-in-ano, out of 40 patients 29 patients got complete relief, marked relief was seen in 7 patients out of them 4 patients were referred to anti-tubercular treatment center, 4 patients left against medical advice. In fissure-in-ano-out of 39 patients, 32 patients got complete relief, 5 patients got marked relief, moderate relief observed in 2 patients. These results authenticate the effectiveness of Kṣārasūtra, no adverse effects or recurrence observed in any

  10. Considering benefits and harms of duloxetine for treatment of stress urinary incontinence: a meta-analysis of clinical study reports

    Science.gov (United States)

    Maund, Emma; Guski, Louise Schow; Gøtzsche, Peter C.

    2017-01-01

    BACKGROUND: The European Medicines Agency makes clinical study reports publicly available and publishes reasons for not approving applications for marketing authorization. Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. The reported adverse effects of duloxetine include mental health problems and suicidality. We obtained clinical study reports from the European Medicines Agency concerning use of this drug for stress urinary incontinence. METHODS: We performed a meta-analysis of 4 randomized placebo-controlled trials of duloxetine (involving a total of 1913 patients) submitted to the European Medicines Agency for marketing approval for the indication of stress urinary incontinence in women. We used data from the clinical study reports (totalling 6870 pages and including individual patient data) to assess benefits (including frequency of incontinence and changes in quality-of-life scores, such as Patient Global Impression of Improvement rating) and harms (both general harms, including discontinuation because of adverse events, and harms related to suicidality, violent behaviour and their potential precursors, such as akathisia and activation [stimulating effects such as insomnia, anxiety and agitation]). RESULTS: Duloxetine was significantly better than placebo in terms of percentage change in weekly incontinence episodes (mean difference −13.56%, 95% confidence interval [CI] −21.59% to −5.53%) and change in Incontinence Quality of Life total score (mean difference 3.24, 95% CI 2.00 to 4.48). However, the effect sizes were small, and a sensitivity analysis (with removal of one trial) showed that the number needed to treat for a Patient Global Impression of Improvement rating of “much better or very much better” was 8 (95% CI 6 to 13). The numbers needed to harm were 7 (95% CI 6 to 8) for discontinuing because of an adverse event and 7 (95% CI 6 to 9) for experiencing an activation event. No suicidality

  11. Minimally invasive atlantoaxial fusion: cadaveric study and report of 5 clinical cases.

    Science.gov (United States)

    Srikantha, Umesh; Khanapure, Kiran S; Jagannatha, Aniruddha T; Joshi, Krishna C; Varma, Ravi G; Hegde, Alangar S

    2016-12-01

    OBJECTIVE Minimally invasive techniques are being increasingly used to treat disorders of the cervical spine. They have a potential to reduce the postoperative neck discomfort subsequent to extensive muscle dissection associated with conventional atlantoaxial fusion procedures. The aim of this paper was to elaborate on the technique and results of minimally invasive atlantoaxial fusion. MATERIALS Minimally invasive atlantoaxial fusion was done initially in 4 fresh-frozen cadavers and subsequently in 5 clinical cases. Clinical cases included patients with reducible atlantoaxial instability and undisplaced or minimally displaced odontoid fractures. The surgical technique is illustrated in detail. RESULTS Among the cadaveric specimens, all C-1 lateral mass screws were in the correct position and 2 of the 8 C-2 screws had a vertebral canal breach. Among clinical cases, all C-1 lateral mass screws were in the correct position. Only one C-2 screw had a Grade 2 vertebral canal breach, which was clinically insignificant. None of the patients experienced neurological worsening or implant-related complications at follow-up. Evidence of rib graft fusion or C1-2 joint fusion was successfully demonstrated in 4 cases, and flexion-extension radiographs done at follow-up did not show mobility in any case. CONCLUSIONS Minimally invasive atlantoaxial fusion is a safe and effective alternative to the conventional approach in selected cases. Larger series with direct comparison to the conventional approach will be required to demonstrate clinical benefit presumed to be associated with a minimally invasive approach.

  12. Oral rehabilitation of a patient with amelogenesis imperfecta using removable overlay denture: a clinical report.

    Science.gov (United States)

    Ghodsi, S; Rasaeipour, S; Vojdani, M

    2012-03-01

    The aim of this study was oral rehabilitation of 17-year old patient with amelogenesis imperfecta using removable overlay denture in order to satisfy her esthetic and functional expectations and enhance her self-image. Amelogenesis imperfecta (AI) is a group of genetic disorders that primarily affect the quality and quantity of amelogenesis in both primary and permanent dentitions. The main clinical characteristics are severe attrition, tooth sensitivity and unesthetic appearance. This clinical report illustrates the oral rehabilitation of a 17-year-old girl with hypoplastic-hypomature type of AI with cobalt-chromium (Co-Cr) overlay removable partial denture (ORPD) that is one of the most economical and biocompatible replacements for noble metal and nickel-chromium (Ni-Cr) alloy. The presented case report suggests that Co-Cr ORPD can be a good temporary or even permanent treatment option for AI patients with limited budget, low esthetic concerns or medical limitations. There are major advantages in cast metal ORPDs; they are simpler, less traumatic and less expensive than fixed prosthetic options. This case report supports their use in patients with amelogenesis imperfecta.

  13. Extraction of Left Ventricular Ejection Fraction Information from Various Types of Clinical Reports.

    Science.gov (United States)

    Kim, Youngjun; Garvin, Jennifer H; Goldstein, Mary K; Hwang, Tammy S; Redd, Andrew; Bolton, Dan; Heidenreich, Paul A; Meystre, Stéphane M

    2017-02-02

    Efforts to improve the treatment of congestive heart failure, a common and serious medical condition, include the use of quality measures to assess guideline-concordant care. The goal of this study is to identify left ventricular ejection fraction (LVEF) information from various types of clinical notes, and to then use this information for heart failure quality measurement. We analyzed the annotation differences between a new corpus of clinical notes from the Echocardiography, Radiology, and Text Integrated Utility package and other corpora annotated for natural language processing (NLP) research in the Department of Veterans Affairs. These reports contain varying degrees of structure. To examine whether existing LVEF extraction modules we developed in prior research improve the accuracy of LVEF information extraction from the new corpus, we created two sequence-tagging NLP modules trained with a new data set, with or without predictions from the existing LVEF extraction modules. We also conducted a set of experiments to examine the impact of training data size on information extraction accuracy. We found that less training data is needed when reports are highly structured, and that combining predictions from existing LVEF extraction modules improves information extraction when reports have less structured formats and a rich set of vocabulary.

  14. Automatically correlating clinical findings and body locations in radiology reports using MedLEE.

    Science.gov (United States)

    Sevenster, Merlijn; van Ommering, Rob; Qian, Yuechen

    2012-04-01

    In this paper, we describe and evaluate a system that extracts clinical findings and body locations from radiology reports and correlates them. The system uses Medical Language Extraction and Encoding System (MedLEE) to map the reports' free text to structured semantic representations of their content. A lightweight reasoning engine extracts the clinical findings and body locations from MedLEE's semantic representation and correlates them. Our study is illustrative for research in which existing natural language processing software is embedded in a larger system. We manually created a standard reference based on a corpus of neuro and breast radiology reports. The standard reference was used to evaluate the precision and recall of the proposed system and its modules. Our results indicate that the precision of our system is considerably better than its recall (82.32-91.37% vs. 35.67-45.91%). We conducted an error analysis and discuss here the practical usability of the system given its recall and precision performance.

  15. Synergism of clinical evaluation and penile sonographic imaging in diagnosis of penile fracture: a case report

    Directory of Open Access Journals (Sweden)

    Bello Jibril

    2012-09-01

    Full Text Available Abstract Introduction Penile fracture is an uncommon urologic emergency, and is the traumatic rupture of the tunica albuginea covering the corpus cavernosa. This usually occurs following blunt trauma sustained during coitus, masturbation or self-manipulations to hide or suppress an erection. Clinical diagnosis can often be easily made with typical history and examination findings. However, the patient may present atypically and/or with a suspicion of associated urethral injury. The roles of various diagnostic investigations are being evaluated in these situations. Case presentation We report the case of a 31-year-old African man with penile fracture and suspected associated urethral injury that occurred after self-manipulations to hide an erection. Conclusions Penile ultrasound and sonourethrography provide useful additional diagnostic information to supplement clinical history and physical examination findings and can be performed easily, at low cost and with no delays to surgery.

  16. Brain Malignancy Steering Committee clinical trials planning workshop: report from the Targeted Therapies Working Group.

    Science.gov (United States)

    Alexander, Brian M; Galanis, Evanthia; Yung, W K Alfred; Ballman, Karla V; Boyett, James M; Cloughesy, Timothy F; Degroot, John F; Huse, Jason T; Mann, Bhupinder; Mason, Warren; Mellinghoff, Ingo K; Mikkelsen, Tom; Mischel, Paul S; O'Neill, Brian P; Prados, Michael D; Sarkaria, Jann N; Tawab-Amiri, Abdul; Trippa, Lorenzo; Ye, Xiaobu; Ligon, Keith L; Berry, Donald A; Wen, Patrick Y

    2015-02-01

    Glioblastoma is the most common primary brain malignancy and is associated with poor prognosis despite aggressive local and systemic therapy, which is related to a paucity of viable treatment options in both the newly diagnosed and recurrent settings. Even so, the rapidly increasing number of targeted therapies being evaluated in oncology clinical trials offers hope for the future. Given the broad range of possibilities for future trials, the Brain Malignancy Steering Committee convened a clinical trials planning meeting that was held at the Udvar-Hazy Center in Chantilly, Virginia, on September 19 and 20, 2013. This manuscript reports the deliberations leading up to the event from the Targeted Therapies Working Group and the results of the meeting.

  17. Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.

    Science.gov (United States)

    Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

    2015-06-01

    Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  18. Patient reported outcomes (PROs in clinical trials: is 'in-trial' guidance lacking? a systematic review.

    Directory of Open Access Journals (Sweden)

    Derek G Kyte

    Full Text Available BACKGROUND: Patient reported outcomes (PROs are increasingly assessed in clinical trials, and guidelines are available to inform the design and reporting of such trials. However, researchers involved in PRO data collection report that specific guidance on 'in-trial' activity (recruitment, data collection and data inputting and the management of 'concerning' PRO data (i.e., data which raises concern for the well-being of the trial participant appears to be lacking. The purpose of this review was to determine the extent and nature of published guidelines addressing these areas. METHODS AND FINDINGS: Systematic review of 1,362 articles identified 18 eligible papers containing 'in-trial' guidelines. Two independent authors undertook a qualitative content analysis of the selected papers. Guidelines presented in each of the articles were coded according to an a priori defined coding frame, which demonstrated reliability (pooled Kappa 0.86-0.97, and validity (<2% residual category coding. The majority of guidelines present were concerned with 'pre-trial' activities (72%, for example, outcome measure selection and study design issues, or 'post-trial' activities (16% such as data analysis, reporting and interpretation. 'In-trial' guidelines represented 9.2% of all guidance across the papers reviewed, with content primarily focused on compliance, quality control, proxy assessment and reporting of data collection. There were no guidelines surrounding the management of concerning PRO data. CONCLUSIONS: The findings highlight there are minimal in-trial guidelines in publication regarding PRO data collection and management in clinical trials. No guidance appears to exist for researchers involved with the handling of concerning PRO data. Guidelines are needed, which support researchers to manage all PRO data appropriately and which facilitate unbiased data collection.

  19. Weightbath hydrotraction treatment: application, biomechanics, and clinical effects

    Directory of Open Access Journals (Sweden)

    Márta Kurutz

    2010-04-01

    Full Text Available Márta Kurutz1, Tamás Bender21Department of Structural Mechanics, Budapest University of Technology and Economics, Hungary; 2Department of Physical Medicine, Polyclinic and Hospital of the Hospitaller Brothers of St. John of God, Budapest, Medical University of Szeged, HungaryBackground and purpose: Weightbath hydrotraction treatment (WHT is a simple noninvasive effective method of hydro- or balneotherapy to stretch the spine or lower limbs, applied successfully in hospitals and health resort sanitaria in Hungary for more than fifty years. This study aims to introduce WHT with its biomechanical and clinical effects. History, development, equipment, modes of application, biomechanics, spinal traction forces and elongations, indications and contraindications of WHT are precented.Subjects and methods: The calculation of traction forces acting along the spinal column during the treatment is described together with the mode of suspension and the position of extra weight loads applied. The biomechanics of the treatment are completed by in vivo measured elongations of lumbar segments using a special underwater ultrasound measuring method. The clinical effects, indications, and contraindications of the treatment are also presented.Results: In the underwater cervical suspension of a human body, approximately 25 N stretching load occurs in the cervical spine, and about 11 N occurs in the lumbar spine. By applying extra weights, the above tensile forces along the spinal column can be increased. Thus, the traction effect can be controlled by applying such loads during the treatment. Elongations of segments L3–L4, L4–L5, and L5–S1 were measured during the usual WHT of patients suspended cervically in water for 20 minutes, loaded by 20–20 N lead weights on the ankles. The mean initial elastic elongations of spinal segments were about 0.8 mm for patients aged under 40 years, 0.5 mm between 40–60 years, and 0.2 mm for patients over 60 years. The mean

  20. Adolescent Idiopathic Scoliosis – case report of a patient with clinical deterioration after surgery

    Directory of Open Access Journals (Sweden)

    Weiss Hans-Rudolf

    2007-12-01

    Full Text Available Abstract Background Although there is no evidence that the long-term effects of scoliosis surgery are superior to the long-term effects of Adolescent Idiopathic Scoliosis (AIS itself, patients can fear the consequences of not under going this surgery due to incorrect or insufficient information. The main indication for surgical treatment in patients with AIS, is cosmetic. However spinal surgery may, along with other negative side effects, actually cause postoperative clinical deterioration. This complication of surgery has not yet been described in international literature. Case presentation A 15-year old female patient originally presenting with a well-compensated double curve pattern scoliosis. The patient was advised to undergo surgery due to the long-term negative impact of signs and symptoms of scoliosis upon her health. The patient agreed to surgery, which was performed in one of Germanys leading centres for spinal surgery. The thoracolumbar curve was corrected and fused, while the thoracic curve, clearly showing wedged vertebrae, defined as structural scoliosis, remained untreated. This operation left the patient with an unbalanced appearance, with radiological and clinical imbalance to the right. The clinical appearance of the patient though clearly deteriorated post-surgery. Furthermore, the wedged disc space below the fusion area indicates future problems with possible destabilisation accompanied probably by low back pain. Conclusion Scoliosis surgery for patients with AIS is mainly indicated for cosmetic or psychological reasons. Therefore the treatment leading to the best possible clinical appearance and balance has to be chosen. Patients should be informed that surgery will not necessarily improve their health status. Clinical deterioration after surgery may occur, and such information is crucial for an adequate informed consent.

  1. Documentation of functional and clinical effects of infant nutrition

    DEFF Research Database (Denmark)

    Koletzko, Berthold; Szajewska, Hania; Ashwell, Margaret

    2012-01-01

    The Early Nutrition Academy and the Child Health Foundation, in collaboration with the Committee on Nutrition, European Society for Paediatric Gastroenterology, Hepatology and Nutrition, held a workshop in March 2011 to explore guidance on acquiring evidence on the effects of nutritional interven...... interventions in infants and young children. The four objectives were to (1) provide guidance on the quality and quantity of evidence needed to justify conclusions on functional and clinical effects of nutrition in infants and young children aged......The Early Nutrition Academy and the Child Health Foundation, in collaboration with the Committee on Nutrition, European Society for Paediatric Gastroenterology, Hepatology and Nutrition, held a workshop in March 2011 to explore guidance on acquiring evidence on the effects of nutritional...

  2. Clinical and laboratory features of Streptococcus salivarius meningitis: a case report and literature review.

    Science.gov (United States)

    Wilson, Megan; Martin, Ryan; Walk, Seth T; Young, Carol; Grossman, Sylvia; McKean, Erin Lin; Aronoff, David M

    2012-02-01

    Streptococcus salivarius is a normal member of the human oral microbiome that is an uncommon cause of invasive infections. Meningitis is a rare but increasingly reported infection caused by S. salivarius. Despite the growing number of reported cases, a comprehensive review of the literature on S. salivarius meningitis is lacking. We sought to gain a better understanding of the clinical presentation, evaluation, management, and outcome of S. salivarius meningitis by analyzing previously reported cases. In addition to a single case reported here, 64 previously published cases of meningitis were identified for this review. The collected data confirm that most patients presented with classical signs and symptoms of bacterial meningitis with a predominance of neutrophils in the cerebrospinal fluid (CSF) and hypoglycorrhachia. The majority of cases followed iatrogenic or traumatic CSF contamination. Most cases were diagnosed by CSF culture within one day of symptom onset. There was no clear evidence of predisposing co-morbid conditions in patients with meningitis, although in most case reports, limited information was given on the medical history of each patient. Outcomes were generally favorable with antibiotic management. Clinicians should suspect S. salivarius meningitis in patients presenting acutely after medical or surgical procedures involving the meninges.

  3. How to write an effective referee report

    OpenAIRE

    Neill, Ushma S.

    2009-01-01

    Most scientists learn how to review papers by being thrown into the deep end of the pool: here’s a paper, write a review. Perhaps this is not the best way to keep an enterprise afloat. But what should be included in a review? What should the tone of a review be? Here I want to outline the specifics of what we at the JCI are looking for in a referee report.

  4. How to write an effective referee report.

    Science.gov (United States)

    Neill, Ushma S

    2009-05-01

    Most scientists learn how to review papers by being thrown into the deep end of the pool: here's a paper, write a review. Perhaps this is not the best way to keep an enterprise afloat. But what should be included in a review? What should the tone of a review be? Here I want to outline the specifics of what we at the JCI are looking for in a referee report.

  5. Clinical effect of platelet rich fibrin in the treatment of periodontal intrabony defects. Systematic review and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Heber Arbildo.

    2017-05-01

    Full Text Available Background: There is currently no gold standard biomaterial for the treatment of periodontal intrabony defects (PIDs. One of the current options is the use of platelet-rich fibrin (PRF. Objective: To determine the clinical effect of PRF in the treatment of PID through a systematic review and meta-analysis. Materials and Methods: A literature search was conducted up to February 2017 in the following biomedical databases: Pubmed, Embase, Scielo, Science Direct, SIGLE, LILACS and in the Cochrane Central Register of Clinical Trials. The selection criteria included: randomized clinical trials published in the last 5 years, reporting clinical effects (probing depth, clinical insertion level or gingival recession, with a follow-up time equal to or greater than 6 months, and sample size larger than or equal to 10 patients reporting the use of PRF as a treatment for PID. The methodological quality of the studies was analyzed using the Cochrane Handbook of Systematic Reviews of Interventions as a reference. Results: The search strategy yielded 20 articles. A reduction in probing depth and an increase in clinical insertion level or a reduction in gingival recession is reported, when using PRF alone or in combination with another biomaterial or substance that stimulates tissue regeneration. Conclusion: The literature suggests that the use of PRF in the treatment of PIDs has a beneficial clinical effect when compared to control treatments.

  6. [Metallic mercury poisoning and neuropsychological effects: a case report].

    Science.gov (United States)

    Cöp, Esra; Cengel Kültür, S Ebru; Erdoğan Bakar, Emel

    2014-01-01

    Mercury is an extremely toxic heavy metal that can devastate central nervous system. We present the case of a 15 year old adolescent with mercury intoxication following 4 days of exposure to elemental mercury at home who was consulted by department of pediatrics with complaints of demonstrated emotional lability, memory impairment, disinhibition, and impulsivity. Olanzapin 2,5 mg/day was initiated. Her neuropsychological performance was evaluated by a neuropsychological test battery at initial examination. Deterioration in neuropsychological functions like interference effect and attention (Stroop Test TBAG form), verbal fluency and switching to other category (Verbal Fluency Test, /(VFT), verbal short term and long term memory and recognition (Auditory Verbal Learning Test, /(AVLT) was detected. In 9 months follow up period her complaints resolved. Initial neuropsychological deficits were also fully recovered at follow up. There was an increase in intelligence scores with increased ability to pay and sustain attention. She had better performance at Stroop Test TBAG form, VFT and AVLT which was similar to her normal peers. In this case report, the clinical aspects of central nervous system involvement in mercury intoxication and protection from potential toxic effects of laboratory materials like mercury at schools were discussed. School administrators should be aware of and parents and students should be given necessary protective information.

  7. Effect of Multi Mentoring Educational Method on Clinical Competence of Nursing Students

    Directory of Open Access Journals (Sweden)

    R Hosseinabadi

    2015-09-01

    Full Text Available Introduction: Mentoring, as a strategy, plays an important role in professional development of nursing students . Hence, this study was aimed to determine the effect of multi-mentoring educational method on clinical competencies of 8th term nursing students.   Methods: In this intervention study, all of 8th term nursing students of Khorramabad school of nursing in two consecutive term were selected through census method and divided into two groups of mentorship and control(routine trough simple random method. The subjects in the mentorship group completed their field training with corporation of two mentors. The subjects in the control group done their training in the presence of a full-time instructor. Nursing student's clinical competence was measured before and 10 weeks after the intervention using the 6-dimension scale of clinical competencies. Furthermore, the mentor-ship group in regard with the study date were analyzed using descriptive statistics and T-test.   Findings: The results of paired t-test demo instructed a significant difference in the sub-score of teaching-collaboration and total score of clinical competence (p0.05. Moreover, significant difference was reported in the scores of planning/evaluation of nursing care, interpersonal relationship s well as total score of clinical competence between the two groups (p<0.05.   Conclusion: The finding of this study revealed that implementing multi-mentoring method can result in promoting nursing student’s clinical competence and increasing their satisfaction with the course.

  8. Clinical and therapeutic considerations of rectal lymphoma: A case report and literature review

    Institute of Scientific and Technical Information of China (English)

    Yilmaz Bilsel; Emre Balik; Sumer Yamaner; Dursun Bugra

    2005-01-01

    Primary rectal lymphoma is a rare presentation of gastrointestinal lymphomas. Its clinical presentation is indistinguishable from that of rectal carcinoma. Although surgical resection is often technically feasible, optimal therapy for colorectal lymphoma has not yet been identified.We report a case of primary rectal lymphoma (nonHodgkin's large cell lymphoma of type B) with high-grade features that disappeared completely after chemoradiotherapy. This case underlines that primary treatment with systemic chemotherapy and involved-field radiotherapy can be successful for rectal lymphoma, with surgery reserved for complications and chemotherapy failures.

  9. [Ethical issues in a market dispute between clinical laboratories and a health plan: case report].

    Science.gov (United States)

    Pinheiro, Malone Santos; de Brito, Ana Maria Guedes; Jeraldo, Verônica de Lourdes Sierpe; Pinheiro, Kariny Souza

    2011-01-01

    In Brazil the private health plans appear as an alternative to the public health assistance. This segment suffered great intensification in the seventies and eighties, culminating in the entry of large insurance company in the scenario of supplementary medicine. Quickly, the service providers associated with these insurance companies, consolidating them in the market and triggering a relationship of dependency. This article analyzed, in the form of a case report, a marketing dispute between clinical laboratories and a health plan, emphasizing the moral and ethical aspects involved in this episode.

  10. Clinical and Echographic Long-Term Follow-Up of a Retinal Macrocyst: A Case Report

    Directory of Open Access Journals (Sweden)

    Juan Carlos Serna-Ojeda

    2014-06-01

    Full Text Available The purpose of this paper is to report the case of a 62-year-old male diagnosed with a retinal macrocyst secondary to a long-standing retinal detachment in his right eye. At fundoscopy examination, an oval, elevated retinal lesion in the superior nasal quadrant was noted. Ultrasonography was performed, with a B-mode echography showing an oval, anechoic image and a standardized A-mode echography with a reflectivity spike higher than 98%, which was compatible with a retinal macrocyst. The patient refused surgical treatment for the retinal detachment and was followed for 14 months with stable visual acuity and no clinical or echographic changes.

  11. Dental management of early childhood caries in spastic quadriparesis: a case report and clinical guidelines.

    Science.gov (United States)

    Hotwani, Kavita; Sharma, Krishna

    2013-01-01

    Cerebral palsy (CP) describes a group of permanent disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The motor disorders of CP are often accompanied by epilepsy, secondary musculoskeletal problems, and disturbances of sensation, perception, cognition, communication, and behavior. Spastic quadriparesis is the most severe form of spastic cerebral palsy. The present report describes the management of a 5-year-old patient with early childhood caries and spastic quadriparesis. The oral manifestations and clinical guidelines are discussed considering the special health care needs in these patients so as to provide comprehensive dental care.

  12. Metal-ceramic dowel crown restorations for severely damaged teeth: A clinical report

    Directory of Open Access Journals (Sweden)

    Yuzugullu Bulem

    2009-01-01

    Full Text Available This clinical report describes an alternative prosthodontic treatment of a patient who had severely damaged endodontically-treated first molar teeth in all quadrants of her mouth. The young patient′s severely damaged permanent molar teeth were treated with a restoration combining the advantage of the esthetics of dental porcelain, reinforced with the underlying cast gold dowel crown. Using this technique, the remaining sound tooth structure was preserved with function and esthetics accomplished. The described metal-ceramic one piece dowel crown restoration seemed to perform without any problems for the 12 month evaluation time.

  13. Presurgical management of unilateral cleft lip and palate in a neonate: a clinical report.

    Science.gov (United States)

    Avhad, Rajendra; Sar, Ranjukta; Tembhurne, Jyoti

    2014-09-01

    A cleft lip and palate consists of fissures of the upper lip and/or palate, and is the most commonly seen orofacial anomaly that involves the middle third of the face. Early treatment of patients with a cleft lip and palate is important because of esthetic, functional, and psychological concerns. Nasoalveolar molding provides excellent results when started immediately after birth. This clinical report describes the presurgical management of an infant with a complete unilateral cleft of the soft palate, hard palate, alveolar ridge, and lip.

  14. Unicystic Ameloblastoma of Mandible Treated with an Innovative Approach: A Clinical Case Report.

    Science.gov (United States)

    Babu, Narendra; Charles, Nsc; Rai, Raj; Mathur, Smita; Runwal, Sameer Hemant

    2015-07-01

    Ameloblastoma is a true benign neoplasm with its origin from remnants of odontogenic epithelium. Unicystic ameloblastoma presents as a cystic lesion which clinically, radiographically, and macroscopically mimics a mandibular cyst, but microscopically exhibits ameloblastic epithelium lining part of the cyst cavity, with or without intraluminal growth and tumour infiltration into the fibrous connective tissue wall. An important and perplexing aspect associated with ameloblastoma is its management. We hereby present a case of unicystic ameloblastoma in a 63-year-old female and report an innovative technique of treating the case with split iliac crest graft.

  15. Reinforcement of thin-walled root canal structures for placement of esthetic dowels: a clinical report.

    Science.gov (United States)

    Ayad, Mohamed F; Bahannan, Salma A; Rosenstiel, Stephen F

    2011-01-01

    Thin-walled root canals always present a challenge to dentists to select a restorative treatment that does not further weaken the thin tooth structure. The prognosis of dowel and core restorations can be unpredictable. This clinical report describes the treatment of a patient with extensive caries extending into the root canal of an endodontically treated maxillary central incisor. The use of a flowable composite resin in combination with a quartz fiber reinforced post is described, resulting in the rehabilitation of a structurally compromised root canal with satisfactory esthetic and functional outcomes.

  16. Brief strategic therapy in a child community clinic. A follow-up report.

    Science.gov (United States)

    Eisenberg, J; Wahrman, O

    1994-01-01

    This paper reports the outcome of brief strategic therapy, practiced according to the model described by S. de Shazer, in an out-patient child psychiatry clinic during 4 years. Forty-two clients were interviewed in a span of 6 to 18 months after termination of therapy and asked about symptomatic improvement and satisfaction with the treatment. The results showed that brief strategic therapy achieved lasting complaint resolution in a high percentage of cases, high satisfaction rates with little relapse or need for additional interventions.

  17. Effect of montelukast on clinical score and cytokine levels of infants for clinically diagnosed acute bronchiolitis.

    Science.gov (United States)

    Tahan, Fulya; Celik, Serkan; Eke Gungor, Hatice

    2015-01-01

    Acute bronchiolitis comprises a major cause for morbidity in infants with viral infection which induces an immune inflammatory response that may produce long lasting harmful effects. Currently, there is no effective therapy for bronchiolitis. Our aim was to investigate the efficacy of five-day montelukast therapy in acute bronchiolitis management. The study included 50 infants with acute bronchiolitis. The infants with first episode of acute bronchiolitis were randomly assigned to receive daily montelukast dose of 4mg over five days after admission or no treatment. Plasma eotaxin, IL-4, IL-8 and IFN-gamma levels were evaluated before and after treatment by ELISA method. In the present study, the primary outcome measure was change in clinical severity score, whilst secondary outcome measures were changes in plasma eotaxin, IL-4, IL-8, IFN-gamma levels. No significant differences was found in clinical severity score with five-day montelukast treatment (p>0.05, Mann-Whitney U test). There were no significant differences in plasma eotaxin, IL-4, IL-8, IFN-gamma levels between the groups (p>0.05 Mann-Whitney U test). There was significant decrease in plasma IFN-gamma levels following five-day montelukast treatment (p=0.027, Wilcoxon). There were no significant differences in plasma IL-4, IL-8, IFN-gamma levels between the groups after five-day montelukast treatment (p>0.05, Wilcoxon). There was significant increase in eotaxin levels after five-day montelukast treatment (p=0.009, Wilcoxon). Our study showed that montelukast affected plasma IFN-gamma and eotaxin levels after five days of treatment. Further studies are needed to demonstrate effects of montelukast on chemokine levels in bronchiolitis. Copyright © 2014 SEICAP. Published by Elsevier Espana. All rights reserved.

  18. Perceptions of nursing students on effective clinical preceptors in Phnom Penh National Hospitals, Cambodia

    Directory of Open Access Journals (Sweden)

    Virya Koy

    2015-07-01

    Full Text Available Background: Nursing education has evolved substantially in the last few decades. Preceptorship is important to nursing education for several reasons. The purpose of this study is to describe the effective nursing clinical preceptors in Phnom Penh National Hospitals. Both preceptors and students have reported experiencing constrained relationships, tension and anxiety, which led to failure result or frustrating experiences in clinical teaching and learning. Methods: The stratified sampling of 166 was invited. A cross-sectional design survey was used. The Cronbach's Alpha Coefficient for all items was 0.945. Results: The findings were given as effective clinical preceptorship had a moderate (3.02, 0.85. The interpersonal relationship (3.51, 0.88, evaluation (3.39, 0.93, personal traits (2.80, 0.83, nursing competencies (3.39, 0.93, and teaching ability (2.70, 0.81. Conclusion: Interpersonal relationship, formative evaluation, giving suggestions and correcting mistakes without belittling was perceived to be important characteristic. It is necessary to integrate clinical teaching skills to clinical preceptors. [Int J Res Med Sci 2015; 3(7.000: 1605-1610

  19. Factors contributing to therapeutic effects evaluated in acupuncture clinical trials

    Directory of Open Access Journals (Sweden)

    Shi Guang-Xia

    2012-04-01

    Full Text Available Abstract Acupuncture treatment has been widely used for many conditions, while results of the increasing numbers of randomized trials and systematic reviews remain controversial. Acupuncture is a complex intervention of both specific and non-specific factors associated with therapeutic benefit. Apart from needle insertion, issues such as needling sensation, psychological factors, acupoint specificity, acupuncture manipulation, and needle duration also have relevant influences on the therapeutic effects of acupuncture. Taking these factors into consideration would have considerable implications for the design and interpretation of clinical trials.

  20. Study on the Clinical Effectiveness of Thymectomy for Myasthenia Gravis

    Institute of Scientific and Technical Information of China (English)

    PANTiecheng; YANHua; ZHANGNi; PANYouming; TANGYingxiong; WENXiang; SONGDingwei; HUMing; LIULigang; LIUZixiong; YANGMingshan; XUJinzhi; PUBitao; GAOBoting

    2002-01-01

    Objectiv:To investigate the theoretical basis and clinical significance of thymectomy in the treatment of myasthenia gravis (MG). Methods:Analyze the changes in the contents of serum AchRab and sIL-2R, lymphocyte subtypes in Peripheral blood lymphocytes before and after thymectomy in 69 patients. Results:In the study group significant changes were found in serum contents of AchRab and sIL-2R before and after operation and there was also remarkable change in the number and constitution of peripheral blood lymphocyte subtypes. Conclusion:Thymectomy is an effective therapy for MG.

  1. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms.

    Science.gov (United States)

    Ramakrishnan, Karthik; Bond, T Christopher; Claxton, Ami; Sood, Vipan C; Kootsikas, Maria; Agnese, Wendy; Sibbel, Scott

    2013-01-01

    One of the most common conditions affecting end-stage renal disease (ESRD) patients undergoing hemodialysis (HD) is pruritus. Studies report that itchy and dry skin, symptoms of pruritus, affect 40%-90% of ESRD patients. Yet, in clinical practice the condition is often underdiagnosed resulting in inadequate management and an underappreciated impact on patient outcomes. Two retrospective analyses were conducted: a preliminary analysis of ESRD patients with pruritus symptoms (n=73,124) undergoing HD or peritoneal dialysis at a large dialysis provider and a subsequent detailed analysis of a homogenous subset of patients undergoing in-center HD (n=38,315). The goal was to better understand the clinical burden of pruritus as it relates to patient characteristics, quality of life, medication use, and HD compliance. This population is commonly burdened by multiple comorbidities and related polypharmaceutical management; identifying the relationship of pruritus to these ailments can help guide future research and resource allocation. The detailed analysis confirmed trends observed in the preliminary analysis: 30% reported being "moderately" to "extremely bothered" by itchiness. The HD patient population with the highest severity of self-reported pruritus also had a consistent trend in overall increased resource utilization - higher monthly doses of erythropoietin-stimulating agents (53,397.1 to 63,405.4 units) and intravenous (IV) iron (237.2 to 247.6 units) and higher use of IV antibiotics (14.1% to 20.7%), as well as poorer quality-of-life measures (25-point reductions in Burden of Disease Score and Effects on Daily Life subscales of the Kidney Disease Quality of Life-36 survey). These results highlight the need to better identify and manage ESRD patients impacted by pruritus, as this symptom is associated with negative clinical outcomes and increased resource utilization. Further studies are needed to evaluate the current economic burden of pruritus in ESRD patients and

  2. Quality of Reporting of Randomized Clinical Trials in Tai Chi Interventions—A Systematic Review

    Directory of Open Access Journals (Sweden)

    Jing-Yi Li

    2011-01-01

    Full Text Available Objectives. To evaluate the reporting quality of published randomized clinical trials (RCTs in the Tai Chi literature following the publication of the CONSORT guidelines in 2001. Data Sources. The OVID MEDLINE and PUBMED databases. Review Methods. To survey the general characteristics of Tai Chi RCTs in the literature, we included any report if (i it was an original report of the trial; (ii its design was RCT; (iii one of the treatments being tested was Tai Chi; and (iv it was in English. In addition, we assessed the reporting quality of RCTs that were published between 2002 and 2007, using a modified CONSORT checklist of 40 items. The adequate description of Tai Chi interventions in these trials was examined against a 10-item checklist adapted from previous reviews. Results. The search yielded 31 Tai Chi RCTs published from 2002 to 2007 and only 11 for 1992–2001. Among trials published during 2002–2007, the most adequately reported criteria were related to background, participant eligibility and interpretation of the study results. Nonetheless, the most poorly reported items were associated with randomization allocation concealment, implementation of randomization and the definitions of period of recruitment and follow-up. In addition, only 23% of RCTs provided adequate details of Tai Chi intervention used in the trials. Conclusion. The findings in this review indicated that the reporting quality of Tai Chi intervention trials is sub-optimal. Substantial improvement is required to meet the CONSORT guidelines and allow assessment of the quality of evidence. We believe that not only investigators, but also journal editors, reviewers and funding agencies need to follow the CONSORT guidelines to improve the standards of research and strengthen the evidence base for Tai Chi and for complementary and alternative medicine.

  3. Photovoltaics effective capacity: Interim final report 2

    Energy Technology Data Exchange (ETDEWEB)

    Perez, R.; Seals, R. [State Univ. of New York, Albany, NY (United States). Atmospheric Sciences Research Center

    1997-11-01

    The authors provide solid evidence, based on more than 8 million data points, that regional photovoltaic (PV) effective capacity is largely unrelated to the region`s solar resource. They confirm, however, that effective capacity is strongly related to load-shape characteristics. The load-shape effective-capacity relationship appears to be valid for end-use loads as small as 100 kW, except possibly in the case of electrically heated buildings. This relationship was used as a tool to produce a US map of PV`s effective capacity. The regions of highest effective capacities include (1) the central US from the northern Great Plains to the metropolitan areas of Chicago and Detroit, down to the lower Mississippi Valley, (2) California and western Arizona, and (3) the northeast metropolitan corridor. The features of this map are considerably different from the traditional solar resource maps. They tend to reflect the socio-economic and climatic factors that indirectly drive PV`s effective capacity: e.g., commercial air-conditioning, little use of electric heat, and strong summer heat waves. The map provides a new and significant insight to a comprehensive valuation of the PV resource. The authors assembled preliminary evidence showing that end-use load type may be related to PV`s effective capacity. Highest effective capacities were found for (nonelectrically heated) office buildings, followed by hospitals. Lowest capacities were found for airports and residences. Many more data points are needed, however, to ascertain and characterize these preliminary findings.

  4. Photovoltaics effective capacity: Interim final report 2

    Energy Technology Data Exchange (ETDEWEB)

    Perez, R.; Seals, R. [State Univ. of New York, Albany, NY (United States). Atmospheric Sciences Research Center

    1997-11-01

    The authors provide solid evidence, based on more than 8 million data points, that regional photovoltaic (PV) effective capacity is largely unrelated to the region`s solar resource. They confirm, however, that effective capacity is strongly related to load-shape characteristics. The load-shape effective-capacity relationship appears to be valid for end-use loads as small as 100 kW, except possibly in the case of electrically heated buildings. This relationship was used as a tool to produce a US map of PV`s effective capacity. The regions of highest effective capacities include (1) the central US from the northern Great Plains to the metropolitan areas of Chicago and Detroit, down to the lower Mississippi Valley, (2) California and western Arizona, and (3) the northeast metropolitan corridor. The features of this map are considerably different from the traditional solar resource maps. They tend to reflect the socio-economic and climatic factors that indirectly drive PV`s effective capacity: e.g., commercial air-conditioning, little use of electric heat, and strong summer heat waves. The map provides a new and significant insight to a comprehensive valuation of the PV resource. The authors assembled preliminary evidence showing that end-use load type may be related to PV`s effective capacity. Highest effective capacities were found for (nonelectrically heated) office buildings, followed by hospitals. Lowest capacities were found for airports and residences. Many more data points are needed, however, to ascertain and characterize these preliminary findings.

  5. Department of Clinical Investigation Annual Research Progress Report, Fiscal Year 1984. Volume 1,

    Science.gov (United States)

    1984-10-01

    the Efficacy of Electroacutherapy in the 254 Treatment of Temporormandibular Joint Pain. (C) 9 C-49-83 The Effect of the Periodontal Ligament on...of Periodic Review Results Objective(s): To determine pathologic and clinical-pathologic criteria for the diagnosis of IGA nephropathy, the prognosis ...significance of hematuria, microscopic or macroscopic, as well as prognosis in patients who have neither personal or family history of renal disease, nor

  6. Clinical Trial Electronic Portals for Expedited Safety Reporting: Recommendations from the Clinical Trials Transformation Initiative Investigational New Drug Safety Advancement Project.

    Science.gov (United States)

    Perez, Raymond P; Finnigan, Shanda; Patel, Krupa; Whitney, Shanell; Forrest, Annemarie

    2016-12-15

    Use of electronic clinical trial portals has increased in recent years to assist with sponsor-investigator communication, safety reporting, and clinical trial management. Electronic portals can help reduce time and costs associated with processing paperwork and add security measures; however, there is a lack of information on clinical trial investigative staff's perceived challenges and benefits of using portals. The Clinical Trials Transformation Initiative (CTTI) sought to (1) identify challenges to investigator receipt and management of investigational new drug (IND) safety reports at oncologic investigative sites and coordinating centers and (2) facilitate adoption of best practices for communicating and managing IND safety reports using electronic portals. CTTI, a public-private partnership to improve the conduct of clinical trials, distributed surveys and conducted interviews in an opinion-gathering effort to record investigator and research staff views on electronic portals in the context of the new safety reporting requirements described in the US Food and Drug Administration's final rule (Code of Federal Regulations Title 21 Section 312). The project focused on receipt, management, and review of safety reports as opposed to the reporting of adverse events. The top challenge investigators and staff identified in using individual sponsor portals was remembering several complex individual passwords to access each site. Also, certain tasks are time-consuming (eg, downloading reports) due to slow sites or difficulties associated with particular operating systems or software. To improve user experiences, respondents suggested that portals function independently of browsers and operating systems, have intuitive interfaces with easy navigation, and incorporate additional features that would allow users to filter, search, and batch safety reports. Results indicate that an ideal system for sharing expedited IND safety information is through a central portal used by

  7. Refeeding syndrome with enteral nutrition in children: a case report, literature review and clinical guidelines.

    Science.gov (United States)

    Afzal, N A; Addai, S; Fagbemi, A; Murch, S; Thomson, M; Heuschkel, R

    2002-12-01

    Refeeding syndrome is a potentially fatal complication of the nutritional management of severely malnourished patients. The syndrome almost always develops during the early stages of refeeding. It can be associated with a severe derangement in electrolyte and fluid balance, and result in significant morbidity and mortality. It is most often reported in adults receiving total parenteral nutrition (TPN), although refeeding with enteral feeds can also precipitate this syndrome. We report what we believe to be the first case of refeeding syndrome in an adolescent with newly diagnosed Crohn's disease. This developed within a few days of starting exclusive polymeric enteral nutrition. A systematic literature review revealed 27 children who developed refeeding syndrome after oral/enteral feeding. Of these, nine died as a direct result of complications of this syndrome. We discuss the implications of this syndrome on clinical practice and propose evidence-based guidelines for its management.

  8. Discrepancy between information reported by the victims of sexual assaults and clinical forensic findings

    DEFF Research Database (Denmark)

    Scherer, Susanne; Hansen, Steen Holger; Lynnerup, Niels

    2014-01-01

    INTRODUCTION: From the clinical forensic examination reports made at the Department of Forensic Medicine, the University of Copenhagen, in 2007 concerning rape, attempted rape and sexual assault (RAS), information about the assault, including both violence and the perpetrator's line of sexual...... action was extracted, analysed and compared to the observed lesions (LE). MATERIAL AND METHODS: A total of 184 girls and women were included in this retrospective study. RESULTS: 75.5% of the victims were under 30 years of age. Observed LE: 79% had observed LE. 41% had body LE only, 19% genito-anal LE...... only, and 40% had both body and genito-anal LE. Half of the victims, who reported no exposure to violence, had body LE. Five victims also had LE of a self-inflicted character. Genito-anal LE: 47% had genito-anal LE, 64% of whom had one or two, commonest a tear. Body LE: 64% had body LE. 57% was caused...

  9. Prosthetic improvement of pronounced buccally positioned zygomatic implants: a clinical report.

    Science.gov (United States)

    Bacchi, Ataís; Santos, Mateus Bertolini Fernandes dos; Pimentel, Marcele Jardim; Nóbilo, Mauro Antonio de Arruda; Consani, Rafael Leonardo Xediek

    2014-08-01

    This report presents a prosthetic technique for the improvement of surgically positioned, buccally placed zygomatic implants with the use of custom abutments for improved retention screw position and an esthetic implant reconstruction. The patient presented four zygomatic implants with pronounced buccal inclination. The anterior implants were inclined toward the location where the anterior artificial teeth should be placed during rehabilitation. As the manufacturer does not provide angulated abutments, we attempted the waxing and overcasting of a prosthetic abutment, repositioning the access holes of the prosthetic screws to a more palatal position. This clinical report demonstrates that abutment customization could be an interesting way to relocate the access holes of the prosthetic screws in cases of zygomatic implants with pronounced buccal inclination.

  10. Primary tuberculous gingival enlargement - A rare clinical entity: Case report and brief review of the literature

    Directory of Open Access Journals (Sweden)

    Suhail Majid Jan

    2014-01-01

    Full Text Available Tuberculosis (TB is a chronic specific granulomatous disease and a major cause of death in developing countries. The clinical presentation of TB lesions of the oral cavity varies widely and can manifest as ulcerations, diffuse inflammatory lesions, granulomas and fissures. Oral lesions generally appear secondary to primary TB infection elsewhere, although primary infection of the oral mucosa by Mycobacterium tuberculosis has also been described. We hereby report a case of primary TB of the gingiva manifesting as gingival enlargement. Diagnosis was based on histopathological examination, complete blood count, X-ray chest and immunological investigations with detection of antibodies against M. tuberculosis. Anti-tuberculous therapy was carried out for over 6 months and was followed by surgical excision of the residual enlargement under local anesthesia. After 1-year follow-up, there was no recurrence of the disease. This case report emphasizes the need for dentists to include TB in the differential diagnosis of various types of gingival enlargements.

  11. Ca2+-Regulated Photoproteins: Effective Immunoassay Reporters

    Directory of Open Access Journals (Sweden)

    Ludmila A. Frank

    2010-12-01

    Full Text Available Ca2+-regulated photoproteins of luminous marine coelenterates are of interest and a challenge for researchers as a unique bioluminescent system and as a promising analytical instrument for both in vivo and in vitro applications. The proteins are comprehensively studied as to biochemical properties, tertiary structures, bioluminescence mechanism, etc. This knowledge, along with available recombinant proteins serves the basis for development of unique bioluminescent detection systems that are “self-contained”, triggerable, fast, highly sensitive, and non-hazardous. In the paper, we focus on the use of photoproteins as reporters in binding assays based on immunological recognition element—bioluminescent immunoassay and hybridization immunoassay, their advantages and prospects.

  12. Methodological quality and reporting of generalized linear mixed models in clinical medicine (2000-2012: a systematic review.

    Directory of Open Access Journals (Sweden)

    Martí Casals

    Full Text Available BACKGROUND: Modeling count and binary data collected in hierarchical designs have increased the use of Generalized Linear Mixed Models (GLMMs in medicine. This article presents a systematic review of the application and quality of results and information reported from GLMMs in the field of clinical medicine. METHODS: A search using the Web of Science database was performed for published original articles in medical journals from 2000 to 2012. The search strategy included the topic "generalized linear mixed models","hierarchical generalized linear models", "multilevel generalized linear model" and as a research domain we refined by science technology. Papers reporting methodological considerations without application, and those that were not involved in clinical medicine or written in English were excluded. RESULTS: A total of 443 articles were detected, with an increase over time in the number of articles. In total, 108 articles fit the inclusion criteria. Of these, 54.6% were declared to be longitudinal studies, whereas 58.3% and 26.9% were defined as repeated measurements and multilevel design, respectively. Twenty-two articles belonged to environmental and occupational public health, 10 articles to clinical neurology, 8 to oncology, and 7 to infectious diseases and pediatrics. The distribution of the response variable was reported in 88% of the articles, predominantly Binomial (n = 64 or Poisson (n = 22. Most of the useful information about GLMMs was not reported in most cases. Variance estimates of random effects were described in only 8 articles (9.2%. The model validation, the method of covariate selection and the method of goodness of fit were only reported in 8.0%, 36.8% and 14.9% of the articles, respectively. CONCLUSIONS: During recent years, the use of GLMMs in medical literature has increased to take into account the correlation of data when modeling qualitative data or counts. According to the current recommendations, the

  13. Automated ancillary cancer history classification for mesothelioma patients from free-text clinical reports.

    Science.gov (United States)

    Wilson, Richard A; Chapman, Wendy W; Defries, Shawn J; Becich, Michael J; Chapman, Brian E

    2010-10-11

    Clinical records are often unstructured, free-text documents that create information extraction challenges and costs. Healthcare delivery and research organizations, such as the National Mesothelioma Virtual Bank, require the aggregation of both structured and unstructured data types. Natural language processing offers techniques for automatically extracting information from unstructured, free-text documents. Five hundred and eight history and physical reports from mesothelioma patients were split into development (208) and test sets (300). A reference standard was developed and each report was annotated by experts with regard to the patient's personal history of ancillary cancer and family history of any cancer. The Hx application was developed to process reports, extract relevant features, perform reference resolution and classify them with regard to cancer history. Two methods, Dynamic-Window and ConText, for extracting information were evaluated. Hx's classification responses using each of the two methods were measured against the reference standard. The average Cohen's weighted kappa served as the human benchmark in evaluating the system. Hx had a high overall accuracy, with each method, scoring 96.2%. F-measures using the Dynamic-Window and ConText methods were 91.8% and 91.6%, which were comparable to the human benchmark of 92.8%. For the personal history classification, Dynamic-Window scored highest with 89.2% and for the family history classification, ConText scored highest with 97.6%, in which both methods were comparable to the human benchmark of 88.3% and 97.2%, respectively. We evaluated an automated application's performance in classifying a mesothelioma patient's personal and family history of cancer from clinical reports. To do so, the Hx application must process reports, identify cancer concepts, distinguish the known mesothelioma from ancillary cancers, recognize negation, perform reference resolution and determine the experiencer. Results

  14. Automated ancillary cancer history classification for mesothelioma patients from free-text clinical reports

    Directory of Open Access Journals (Sweden)

    Richard A Wilson

    2010-01-01

    Full Text Available Background: Clinical records are often unstructured, free-text documents that create information extraction challenges and costs. Healthcare delivery and research organizations, such as the National Mesothelioma Virtual Bank, require the aggregation of both structured and unstructured data types. Natural language processing offers techniques for automatically extracting information from unstructured, free-text documents. Methods: Five hundred and eight history and physical reports from mesothelioma patients were split into development (208 and test sets (300. A reference standard was developed and each report was annotated by experts with regard to the patient′s personal history of ancillary cancer and family history of any cancer. The Hx application was developed to process reports, extract relevant features, perform reference resolution and classify them with regard to cancer history. Two methods, Dynamic-Window and ConText, for extracting information were evaluated. Hx′s classification responses using each of the two methods were measured against the reference standard. The average Cohen′s weighted kappa served as the human benchmark in evaluating the system. Results: Hx had a high overall accuracy, with each method, scoring 96.2%. F-measures using the Dynamic-Window and ConText methods were 91.8% and 91.6%, which were comparable to the human benchmark of 92.8%. For the personal history classification, Dynamic-Window scored highest with 89.2% and for the family history classification, ConText scored highest with 97.6%, in which both methods were comparable to the human benchmark of 88.3% and 97.2%, respectively. Conclusion: We evaluated an automated application′s performance in classifying a mesothelioma patient′s personal and family history of cancer from clinical reports. To do so, the Hx application must process reports, identify cancer concepts, distinguish the known mesothelioma from ancillary cancers, recognize negation

  15. Aprohrne and Scopolamine: Metabolic and Clinical Chemical Effects during Exercise

    Science.gov (United States)

    1989-05-17

    as well as thermoregulation (1,2,12). In fact, in a recent report we have compared the increments in core temperature of sedentary heat- stressed ...EXERCISECONTROL I AMIDOE IOEN AT 20-C ON Cit.ULATING LEVELS OF SODIUM. POTASSIUM. AND LACTATESCOPOLAMINE APROPHEN ________ ___ ___ LOW DOSE LOW DOSE...the effects of this anticholinergic on heating rate in a sedentary, heat- stressed rat model. Freireich et al. (5) had earlier hypothesized that an

  16. Suicidality and aggression during antidepressant treatment: systematic review and meta-analyses based on clinical study reports

    Science.gov (United States)

    Guski, Louise Schow; Freund, Nanna; Gøtzsche, Peter C

    2016-01-01

    Objective To study serious harms associated with selective serotonin and serotonin-norepinephrine reuptake inhibitors. Design Systematic review and meta-analysis. Main outcome measures Mortality and suicidality. Secondary outcomes were aggressive behaviour and akathisia. Data sources Clinical study reports for duloxetine, fluoxetine, paroxetine, sertraline, and venlafaxine obtained from the European and UK drug regulators, and summary trial reports for duloxetine and fluoxetine from Eli Lilly’s website. Eligibility criteria for study selection Double blind placebo controlled trials that contained any patient narratives or individual patient listings of harms. Data extraction and analysis Two researchers extracted data independently; the outcomes were meta-analysed by Peto’s exact method (fixed effect model). Results We included 70 trials (64 381 pages of clinical study reports) with 18 526 patients. These trials had limitations in the study design and discrepancies in reporting, which may have led to serious under-reporting of harms. For example, some outcomes appeared only in individual patient listings in appendices, which we had for only 32 trials, and we did not have case report forms for any of the trials. Differences in mortality (all deaths were in adults, odds ratio 1.28, 95% confidence interval 0.40 to 4.06), suicidality (1.21, 0.84 to 1.74), and akathisia (2.04, 0.93 to 4.48) were not significant, whereas patients taking antidepressants displayed more aggressive behaviour (1.93, 1.26 to 2.95). For adults, the odds ratios were 0.81 (0.51 to 1.28) for suicidality, 1.09 (0.55 to 2.14) for aggression, and 2.00 (0.79 to 5.04) for akathisia. The corresponding values for children and adolescents were 2.39 (1.31 to 4.33), 2.79 (1.62 to 4.81), and 2.15 (0.48 to 9.65). In the summary trial reports on Eli Lilly’s website, almost all deaths were noted, but all suicidal ideation events were missing, and the information on the remaining outcomes was

  17. The TCM Remedies for Treatment of AIDS——A Clinical Report of 60 Cases

    Institute of Scientific and Technical Information of China (English)

    Han Guihua; Mao Shuzhang

    2007-01-01

    Objective: To evaluate the clinical effects of TCM remedies in treatment of acquired immune deficiency syndrome (AIDS). Method: 60 cases of AIDS or AIDS-related complex (ARC) were divided into four different TCM patterns and treated accordingly. Results: Of the 60 cases, 52 patients (86.7%)experienced remarkable improvement in general symptoms and lab findings, including virus loading and CD4 T lymphocyte count. Conclusion: The TCM remedies could definitely improve the symptoms and signs of AIDS or ARC, enhance the immune function, decrease the possibility of contracting opportunistic infection, improve the life quality, and prolong the survival period, with no apparent toxic and side effects.

  18. Ubiquitous Diabetes Management System via Interactive Communication Based on Information Technologies: Clinical Effects and Perspectives

    Science.gov (United States)

    Cho, Jae-Hyoung; Kim, Hun-Sung; Han, Jae-Hoon; Lee, Jin-Hee; Oh, Jeong-Ah; Choi, Yoon-Hee

    2010-01-01

    New diabetes management systems based on interactive communication have been introduced recently, accompanying rapid advances in information technology; these systems are referred to as "ubiquitous diabetes management systems." In such ubiquitous systems, patients and medical teams can communicate via Internet or telecommunications, with patients uploading their glucose data and personal information, and medical teams sending optimal feedback. Clinical evidence from both long-term and short-term trials has been reported by some researchers. Such systems appear to be effective not only in reducing the levels of HbA1c but also in stabilizing glucose control. However, most notably, evidence for the cost-effectiveness of such a system should be demonstrated before it can be propagated out to the general population in actual clinical practice. To establish a cost-effective model, various types of clinical decision supporting software designed to reduce the labor time of physicians must first be developed. A number of sensors and devices for monitoring patients' data are expected to be available in the near future; thus, methods for automatic interconnections between devices and web charts were also developed. Further investigations to demonstrate the clinical outcomes of such a system should be conducted, hopefully leading to a new paradigm of diabetes management. PMID:21076573

  19. The Effects of Aging on Clinical Vestibular Evaluations.

    Science.gov (United States)

    Maheu, Maxime; Houde, Marie-Soleil; Landry, Simon P; Champoux, François

    2015-01-01

    Balance disorders are common issues for aging populations due to the effects of normal aging on peripheral vestibular structures. These changes affect the results of vestibular function evaluations and make the interpretation of these results more difficult. The objective of this article is to review the current state of knowledge of clinically relevant vestibular measures. We will first focus on otolith function assessment methods cervical-VEMP (cVEMP) and ocular-VEMP (oVEMP), then the caloric and video-head impulse test (vHIT) methods for semicircular canals assessment. cVEMP and oVEMP are useful methods, though research on the effects of age for some parameters are still inconclusive. vHIT results are largely independent of age as compared to caloric stimulation and should therefore be preferred for the evaluation of the semicircular canals function.

  20. Aloe vera: A review of toxicity and adverse clinical effects.

    Science.gov (United States)

    Guo, Xiaoqing; Mei, Nan

    2016-04-01

    The Aloe plant is employed as a dietary supplement in a variety of foods and as an ingredient in cosmetic products. The widespread human exposure and its potential toxic and carcinogenic activities raise safety concerns. Chemical analysis reveals that the Aloe plant contains various polysaccharides and phenolic chemicals, notably anthraquinones. Ingestion of Aloe preparations is associated with diarrhea, hypokalemia, pseudomelanosis coli, kidney failure, as well as phototoxicity and hypersensitive reactions. Recently, Aloe vera whole leaf extract showed clear evidence of carcinogenic activity in rats, and was classified by the International Agency for Research on Cancer as a possible human carcinogen (Group 2B). This review presents updated information on the toxicological effects, including the cytotoxicity, genotoxicity, carcinogenicity, and adverse clinical effects of Aloe vera whole leaf extract, gel, and latex.

  1. The effects of aging on clinical vestibular evaluations

    Directory of Open Access Journals (Sweden)

    Maxime eMaheu

    2015-09-01

    Full Text Available Balance disorders are common issues for aging populations due to the effects of normal aging on peripheral vestibular structures. These changes affect the results of vestibular function evaluations and make the interpretation of these results more difficult. The objective of this article is to review the current state of knowledge of clinically relevant vestibular measures. We will first focus on otolith function assessment methods cVEMP and oVEMP, then the caloric and vHIT methods for semi-circular canals assessment. cVEMP and oVEMP are useful methods, though research on the effects of age for some parameters are still inconclusive. vHIT results are largely independent of age as compared to caloric stimulation and should therefore be preferred for the evaluation of the semi-circular canals function.

  2. CNS pharmacology and clinical therapeutic effects of oxiracetam.

    Science.gov (United States)

    Itil, T M; Menon, G N; Songar, A; Itil, K Z

    1986-01-01

    Oxiracetam, a new substance found to be a nootropic in experimental pharmacological studies, was tested in three clinical trials: a single rising dose tolerance and dose-finding study with quantitative pharmaco-electroencephalogram (pharmaco-EEG) and quantitative pharmacopsychology in healthy volunteers; a dose-finding study, at three dose levels for 3 months, with quantitative pharmaco-EEG in mild to moderate dementia patients; and a safety and efficacy study with increasing dosages for 12 weeks with subjective and objective tests in elderly patients with dementia. In single and repeated oral dosages up to 2,400 mg, oxiracetam is a safe compound. According to HZI Data Bank Classification Systems, oxiracetam is a vigilance-enhancing compound with some effects on spontaneous memory. The therapeutic effect of oxiracetam can be discriminated from placebo, and in comparison with piracetam, oxiracetam exhibits greater improvement in memory factor.

  3. Berberine: metabolic and cardiovascular effects in preclinical and clinical trials

    Directory of Open Access Journals (Sweden)

    Arrigo FG Cicero

    2009-09-01

    Full Text Available Arrigo FG Cicero1, Sibel Ertek21Internal Medicine, Aging and Kidney Diseases Department, Sant’Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy; 2Ufuk University, Medical Faculty, Dr Ridvan Ege Hospital, Department of Endocrinology and Metabolic Diseases, Ankara, TurkeyAbstract: Berberine is a plant alkaloid with numerous biological activities. A large body of preclinical in vitro and in vivo studies support different pharmacological actions of berberine that could be potentially useful in the management of metabolic diseases associated with high cardiovascular disease risk, such as mixed hyperlipidemia, insulin resistance, metabolic syndrome, and type 2 diabetes. Moreover, it seems that berberine also exerts anti-inflammatory and antiproliferative effects that could play a role in the development of atherosclerosis and its clinical consequences. Recently, the metabolic effects of berberine have been demonstrated in humans, opening new perspectives for the use of this molecule in patient therapy. Larger and longer clinical studies need to be carried out to implement the definition of the therapeutic role of berberine in humans.Keywords: berberine, cardiovascular disease, diabetes, cholesterol

  4. Clinical Effectiveness Evaluation of a New Whitening Dentifrice.

    Science.gov (United States)

    Ghassemi, A; Vorwerk, L; Cirigliano, A; Hooper, W; DeSciscio, P; Nathoo, S

    2015-01-01

    This randomized controlled clinical trial was conducted to determine the effectiveness and safety of a new whitening dentifrice. One hundred eighty-two qualifying subjects were randomly assigned to either a whitening dentifrice group (Arm & Hammer Truly Radiant Toothpaste), a negative control dentifrice group (Colgate Cavity Protection Toothpaste), or a positive control dentifrice group (Crest 3-D White Radiant Mint Toothpaste) and were instructed to brush twice daily with their assigned dentifrice for six weeks. Extrinsic tooth stain was assessed using a Modified Lobene Stain Index (MLSI) and tooth shade was assessed using the VITA Classic Shade Guide at baseline and after five days and two, four, and six weeks of dentifrice use. Safety was monitored by clinical examinations and panelist assessment at each evaluation period. The Arm & Hammer Truly Radiant group showed a statistically significant improvement from baseline in mean composite MLSI and VITA shade at each examination period (p dentifrices for these parameters (p dentifrice formulation is safe and effective on stain removal and tooth whitening.

  5. Opportunities and challenges associated with clinical diagnostic genome sequencing: a report of the Association for Molecular Pathology.

    Science.gov (United States)

    Schrijver, Iris; Aziz, Nazneen; Farkas, Daniel H; Furtado, Manohar; Gonzalez, Andrea Ferreira; Greiner, Timothy C; Grody, Wayne W; Hambuch, Tina; Kalman, Lisa; Kant, Jeffrey A; Klein, Roger D; Leonard, Debra G B; Lubin, Ira M; Mao, Rong; Nagan, Narasimhan; Pratt, Victoria M; Sobel, Mark E; Voelkerding, Karl V; Gibson, Jane S

    2012-11-01

    This report of the Whole Genome Analysis group of the Association for Molecular Pathology illuminates the opportunities and challenges associated with clinical diagnostic genome sequencing. With the reality of clinical application of next-generation sequencing, technical aspects of molecular testing can be accomplished at greater speed and with higher volume, while much information is obtained. Although this testing is a next logical step for molecular pathology laboratories, the potential impact on the diagnostic process and clinical correlations is extraordinary and clinical interpretation will be challenging. We review the rapidly evolving technologies; provide application examples; discuss aspects of clinical utility, ethics, and consent; and address the analytic, postanalytic, and professional implications.

  6. Relationship Between Patient-Reported Outcomes and Clinical Outcomes in Patients With Morquio A Syndrome

    Directory of Open Access Journals (Sweden)

    Christina Lampe MD

    2015-04-01

    Full Text Available This cross-sectional analysis assessed the correlation between patient-reported outcomes (PROs and clinical outcomes in 24 German patients with Morquio A. Clinical outcomes included 6-minute walk test (6MWT, 3-minute stair climb (3MSC test, and joint range of motion as measures for endurance/mobility, forced vital capacity (FVC and maximum voluntary ventilation (MVV as measures for respiratory function, and height as an important manifestation. The PROs included the EuroQoL (EQ 5D-5L (EQ5D-5L, to measure health-related QoL (HRQoL, and patients’ rating of their ability to walk, climb, or breathe. In adults, endurance and pulmonary function measures and height showed strong and statistically significant correlation with the patients’ EQ5D-5L (6MWT: R = .884, 3MSC test: R = .852, FVC: R = .815, MVV: R = .825, height: R = .842. The adult patients’ rating of their ability to walk and climb also correlated strongly with 6MWT (R = .839 and 3MSC test (R = .700 results. Improvements in these clinical outcomes may be robust surrogate parameters of a better EQ5D-5L/HRQoL in patients with Morquio A.

  7. Long-term clinical outcome of fetal cell transplantation for Parkinson disease: two case reports.

    Science.gov (United States)

    Kefalopoulou, Zinovia; Politis, Marios; Piccini, Paola; Mencacci, Niccolo; Bhatia, Kailash; Jahanshahi, Marjan; Widner, Håkan; Rehncrona, Stig; Brundin, Patrik; Björklund, Anders; Lindvall, Olle; Limousin, Patricia; Quinn, Niall; Foltynie, Thomas

    2014-01-01

    Recent advances in stem cell technologies have rekindled an interest in the use of cell replacement strategies for patients with Parkinson disease. This study reports the very long-term clinical outcomes of fetal cell transplantation in 2 patients with Parkinson disease. Such long-term follow-up data can usefully inform on the potential efficacy of this approach, as well as the design of trials for its further evaluation. Two patients received intrastriatal grafts of human fetal ventral mesencephalic tissue, rich in dopaminergic neuroblasts, as restorative treatment for their Parkinson disease. To evaluate the very long-term efficacy of the grafts, clinical assessments were performed 18 and 15 years posttransplantation. Motor improvements gained gradually over the first postoperative years were sustained up to 18 years posttransplantation, while both patients have discontinued, and remained free of any, pharmacological dopaminergic therapy. The results from these 2 cases indicate that dopaminergic cell transplantation can offer very long-term symptomatic relief in patients with Parkinson disease and provide proof-of-concept support for future clinical trials using fetal or stem cell therapies.

  8. Undiagnosed tuberculosis as clinical, epidemiological and medicolegal problem: Report of two cases

    Directory of Open Access Journals (Sweden)

    Savić Slobodan

    2006-01-01

    Full Text Available The authors present two cases of undiagnosed tuberculosis in order to point out clinical, epidemiological and medicolegal importance of such cases. The first patient was a 29- year old woman, who died after 10-day hospital treatment, but true nature of her disease remained undiscovered. Due to her known marital problems, as well as numerous bruises developed as a consequence of hemorrhagic syndrome, violent death caused by injuries inflicted by her husband was suspected. Medicolegal autopsy and microscopic examination revealed fatal tuberculosis of the lungs, and small and large intestines. In another case, a 35-year old male died suddenly and unexpectedly, being found dead in his flat where numerous blood traces were noticed during the scene investigation. Therefore, possible homicide was suspected. Medicolegal investigation proved pulmonary tuberculosis as a cause of natural death. Presented cases point out the fact that even nowadays both pulmonary and extrapulmonary tuberculosis may remain clinically undiscovered, even when this disease is a cause of death. Hence, physicians should always keep in mind possible tuberculosis, especially in patients with long-lasting typical symptoms and signs. In both reported cases, the individuals suffered from cavernous pulmonary tuberculosis being thus a permanent source of infection. From medicolegal point of view, described cases represent examples of so called suspicious natural death. On the other hand, the fact that fatal tuberculosis remained clinically undiagnosed may make physicians be accused of medical negligence and malpractice.

  9. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms

    Directory of Open Access Journals (Sweden)

    Ramakrishnan K

    2013-12-01

    Full Text Available Karthik Ramakrishnan,1 T Christopher Bond,1 Ami Claxton,1 Vipan C Sood,2 Maria Kootsikas,2 Wendy Agnese,2 Scott Sibbel11DaVita Clinical Research, Minneapolis, MN, USA; 2Mitsubishi Tanabe Pharma Corporation, Jersey City, NJ, USAAbstract: One of the most common conditions affecting end-stage renal disease (ESRD patients undergoing hemodialysis (HD is pruritus. Studies report that itchy and dry skin, symptoms of pruritus, affect 40%–90% of ESRD patients. Yet, in clinical practice the condition is often underdiagnosed resulting in inadequate management and an underappreciated impact on patient outcomes. Two retrospective analyses were conducted: a preliminary analysis of ESRD patients with pruritus symptoms (n=73,124 undergoing HD or peritoneal dialysis at a large dialysis provider and a subsequent detailed analysis of a homogenous subset of patients undergoing in-center HD (n=38,315. The goal was to better understand the clinical burden of pruritus as it relates to patient characteristics, quality of life, medication use, and HD compliance. This population is commonly burdened by multiple comorbidities and related polypharmaceutical management; identifying the relationship of pruritus to these ailments can help guide future research and resource allocation. The detailed analysis confirmed trends observed in the preliminary analysis: 30% reported being "moderately" to "extremely bothered" by itchiness. The HD patient population with the highest severity of self-reported pruritus also had a consistent trend in overall increased resource utilization – higher monthly doses of erythropoietin-stimulating agents (53,397.1 to 63,405.4 units and intravenous (IV iron (237.2 to 247.6 units and higher use of IV antibiotics (14.1% to 20.7%, as well as poorer quality-of-life measures (25-point reductions in Burden of Disease Score and Effects on Daily Life subscales of the Kidney Disease Quality of Life-36 survey. These results highlight the need to better

  10. Fallout radiation effects analysis methodology. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1988-03-31

    Fallout radiation is viewed by the weapons effects community as a potentially serious impediment to maintaining or restoring critical National Security Emergency Preparedness (NSEP) telecommunication capabilities in a nuclear environment. The OMNCS' Electromagnetic Pulse Mitigation Program is designed, in part, to identify the survival probability (survivability) of the nation's NSEP telecommunications infrastructure against fallout radiation effects. The OMNCS (Office of the Manager National Communications System) is developing a balanced approach consisting of fallout radiation stress tests on the electronic piece-parts and the use of estimated performance measures of telecommunication network elements in network simulation models to predict user connectivity levels. It is concluded that, given limited available data, the proposed method can predict fallout radiation effects on network telecommunication equipment. The effects of fallout radiation are small at low dosage levels (bin 1 and bin 2). More pronounced variations in equipment performance were exhibited for radiation dosage in the 1k-5k Rads(Si) bin. Finally, the results indicate that by increasing the sample size to approximately 200 samples, the statistical quality of survivability predictions can be significantly improved.

  11. Hand hygiene-related clinical trials reported since 2010: a systematic review.

    Science.gov (United States)

    Kingston, L; O'Connell, N H; Dunne, C P

    2016-04-01

    Considerable emphasis is currently placed on reducing healthcare-associated infection through improving hand hygiene compliance among healthcare professionals. There is also increasing discussion in the lay media of perceived poor hand hygiene compliance among healthcare staff. Our aim was to report the outcomes of a systematic search for peer-reviewed, published studies - especially clinical trials - that focused on hand hygiene compliance among healthcare professionals. Literature published between December 2009, after publication of the World Health Organization (WHO) hand hygiene guidelines, and February 2014, which was indexed in PubMed and CINAHL on the topic of hand hygiene compliance, was searched. Following examination of relevance and methodology of the 57 publications initially retrieved, 16 clinical trials were finally included in the review. The majority of studies were conducted in the USA and Europe. The intensive care unit emerged as the predominant focus of studies followed by facilities for care of the elderly. The category of healthcare worker most often the focus of the research was the nurse, followed by the healthcare assistant and the doctor. The unit of analysis reported for hand hygiene compliance was 'hand hygiene opportunity'; four studies adopted the 'my five moments for hand hygiene' framework, as set out in the WHO guidelines, whereas other papers focused on unique multimodal strategies of varying design. We concluded that adopting a multimodal approach to hand hygiene improvement intervention strategies, whether guided by the WHO framework or by another tested multimodal framework, results in moderate improvements in hand hygiene compliance.

  12. Surgical Treatment of Peri-Implantitis: A 17-Year Follow-Up Clinical Case Report

    Directory of Open Access Journals (Sweden)

    Fabrizio Bassi

    2015-01-01

    Full Text Available The purpose of the present case report was to describe the surgical treatment of a peri-implantitis lesion associated with a regenerative approach. A 48-year-old patient came to authors’ attention 36 months after the placement of a dental implant (ITI-Bonefit Straumann, Waldenburg, Switzerland in position 46. A swelling of the peri-implant soft tissues was observed, associated with bleeding on probing and probing depth > 10 mm. A significant peri-implant bone loss was clearly visible on the periapical radiograph. A nonsurgical periodontal supportive therapy was firstly conducted to reduce the inflammation, followed by the surgical treatment of the defect. After mechanical and chemical decontamination with tetracycline solution, a regenerative approach consisting in the application of deproteinized bovine bone mineral (Bio-Oss, Geistlich Pharma AG, Wolhusen, Switzerland and a collagen membrane (Bio-Gide, Geistlich Pharma AG, Wolhusen, Switzerland was performed. An antibiotic therapy was associated with the treatment. The 17-year follow-up showed a physiological probing depth with no clinical signs of peri-implant inflammation and bleeding on probing. No further radiographic bone loss was observed. The treatment described in the present case report seemed to show improved clinical results up to a relevant follow-up period.

  13. Extracting PICO Sentences from Clinical Trial Reports using Supervised Distant Supervision.

    Science.gov (United States)

    Wallace, Byron C; Kuiper, Joël; Sharma, Aakash; Zhu, Mingxi Brian; Marshall, Iain J

    2016-01-01

    Systematic reviews underpin Evidence Based Medicine (EBM) by addressing precise clinical questions via comprehensive synthesis of all relevant published evidence. Authors of systematic reviews typically define a Population/Problem, Intervention, Comparator, and Outcome (a PICO criteria) of interest, and then retrieve, appraise and synthesize results from all reports of clinical trials that meet these criteria. Identifying PICO elements in the full-texts of trial reports is thus a critical yet time-consuming step in the systematic review process. We seek to expedite evidence synthesis by developing machine learning models to automatically extract sentences from articles relevant to PICO elements. Collecting a large corpus of training data for this task would be prohibitively expensive. Therefore, we derive distant supervision (DS) with which to train models using previously conducted reviews. DS entails heuristically deriving 'soft' labels from an available structured resource. However, we have access only to unstructured, free-text summaries of PICO elements for corresponding articles; we must derive from these the desired sentence-level annotations. To this end, we propose a novel method - supervised distant supervision (SDS) - that uses a small amount of direct supervision to better exploit a large corpus of distantly labeled instances by learning to pseudo-annotate articles using the available DS. We show that this approach tends to outperform existing methods with respect to automated PICO extraction.

  14. Clinical features and endodontic treatment of two-rooted mandibular canines: Report of four cases

    Directory of Open Access Journals (Sweden)

    Stojanac Igor

    2014-01-01

    Full Text Available Introduction. Predictable endodontic treatment depends on the dentist’s knowledge about root canal morphology and its possible anatomic variations. The majority of mandibular canines have one root and root canal, but 15% may have two canals and a smaller number may have two distinct roots. The following clinical reports describe endodontic treatment of mandibular canines with two roots and two root canals. Outline of Cases. Four clinical case reports are presented to exemplify anatomical variation in the human mandibular canine. Detailed analysis of the preoperative radiographs and careful examination of the pulp chamber floor detected the presence of two root canal orifices in all canines. Working length was determined with an electronic apex locator and biomechanical preparation was carried out by using engine driven BioRaCe Ni-Ti rotary instruments in a crown-down manner, followed by copious irrigation with 1% sodium hypochlorite. Definitive obturation was performed using cold lateral condensation with gutta-percha cones and Top Seal paste. The treatment outcome was evaluated using postoperative radiographs. Conclusion. Endodontists should be aware of anatomical variations of the treated teeth, and should never presume that canal systems are simple. [Projekat Ministarstva nauke Republike Srbije, br. 174005: Viscoelasticity of fractional type and optimization of shape in rod theory

  15. Effect of staff attitudes on quality in clinical microbiology services.

    Science.gov (United States)

    Pitt, Sarah J; Sands, Richard L

    2002-01-01

    Technical quality of the work of clinical pathology laboratories is monitored regularly by both internal and external sources. Among the factors that might affect quality, laboratory staff attitudes are rarely considered. In this study, the psychological concepts of 'job satisfaction' and 'climate' are measured among microbiology biomedical scientists in the United Kingdom. A self-report questionnaire was developed and distributed (between November 1998 and February 1999) to biomedical scientists in 161 microbiology laboratories throughout the UK From 2415 questionnaires distributed, 931 replies were received--a response rate of 39%. A separate set of questions covering customer service and participation in internal and external quality assurance schemes was sent to laboratory managers. Biomedical scientists reported lower job satisfaction than did medical technologists in a previous study in the USA. Perception of climate was influenced by several demographic factors, the most important of which being the size of the laboratory. Optimal number of staff in a department was found to be less than 30. Aggregation of climate scores from members of the same department showed that a positive laboratory climate was important for good performance in internal and external measures of technical quality. For the best service, laboratory climate must be supported by a staff perception that the department is committed to enhancing quality--a climate for laboratory quality.

  16. Does kinematics add meaningful information to clinical assessment in post-stroke upper limb rehabilitation? A case report

    Science.gov (United States)

    Bigoni, Matteo; Baudo, Silvia; Cimolin, Veronica; Cau, Nicola; Galli, Manuela; Pianta, Lucia; Tacchini, Elena; Capodaglio, Paolo; Mauro, Alessandro

    2016-01-01

    [Purpose] The aims of this case study were to: (a) quantify the impairment and activity restriction of the upper limb in a hemiparetic patient; (b) quantitatively evaluate rehabilitation program effectiveness; and (c) discuss whether more clinically meaningful information can be gained with the use of kinematic analysis in addition to clinical assessment. The rehabilitation program consisted of the combined use of different traditional physiotherapy techniques, occupational therapy sessions, and the so-called task-oriented approach. [Subject and Methods] Subject was a one hemiplegic patient. The patient was assessed at the beginning and after 1 month of daily rehabilitation using the Medical Research Council scale, Nine Hole Peg Test, Motor Evaluation Scale for Upper Extremity in Stroke Patients, and Hand Grip Dynamometer test as well as a kinematic analysis using an optoelectronic system. [Results] After treatment, significant improvements were evident in terms of total movement duration, movement completion velocity, and some smoothness parameters. [Conclusion] Our case report showed that the integration of clinical assessment with kinematic evaluation appears to be useful for quantitatively assessing performance changes. PMID:27630445

  17. Reporting disease activity in clinical trials of patients with rheumatoid arthritis: EULAR/ACR collaborative recommendations.

    Science.gov (United States)

    Aletaha, D; Landewe, R; Karonitsch, T; Bathon, J; Boers, M; Bombardier, C; Bombardieri, S; Choi, H; Combe, B; Dougados, M; Emery, P; Gomez-Reino, J; Keystone, E; Koch, G; Kvien, T K; Martin-Mola, E; Matucci-Cerinic, M; Michaud, K; O'Dell, J; Paulus, H; Pincus, T; Richards, P; Simon, L; Siegel, J; Smolen, J S; Sokka, T; Strand, V; Tugwell, P; van der Heijde, D; van Riel, P; Vlad, S; van Vollenhoven, R; Ward, M; Weinblatt, M; Wells, G; White, B; Wolfe, F; Zhang, B; Zink, A; Felson, D

    2008-10-15

    To make recommendations on how to report disease activity in clinical trials of rheumatoid arthritis (RA) endorsed by the European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR). The project followed the EULAR standardized operating procedures, which use a three-step approach: 1) expert-based definition of relevant research questions (November 2006); 2) systematic literature search (November 2006 to May 2007); and 3) expert consensus on recommendations based on the literature search results (May 2007). In addition, since this is the first joint EULAR/ACR publication on recommendations, an extra step included a meeting with an ACR panel to approve the recommendations elaborated by the expert group (August 2007). Eleven relevant questions were identified for the literature search. Based on the evidence from the literature, the expert panel recommended that each trial should report the following items: 1) disease activity response and disease activity states; 2) appropriate descriptive statistics of the baseline, the endpoints and change of the single variables included in the core set; 3) baseline disease activity levels (in general); 4) the percentage of patients achieving a low disease activity state and remission; 5) time to onset of the primary outcome; 6) sustainability of the primary outcome; 7) fatigue. These recommendations endorsed by EULAR and ACR will help harmonize the presentations of results from clinical trials. Adherence to these recommendations will provide the readership of clinical trials with more details of important outcomes, while the higher level of homogeneity may facilitate the comparison of outcomes across different trials and pooling of trial results, such as in meta-analyses.

  18. Report of a New Case With Pentasomy X and Novel Clinical Findings

    Directory of Open Access Journals (Sweden)

    Demirhan Osman

    2015-06-01

    Full Text Available Pentasomy X is an extremely rare sex chromosome abnormality, a condition that only affects females, in which three more X chromosomes are added to the normally present two chromosomes in females. We investigated the novel clinical findings in a 1-year-old female baby with pentasomy X, and determined the parental origins of the X chromosomes. Our case had thenar atrophy, postnatal growth deficiency, developmental delay, mongoloid slant, microcephaly, ear anomalies, micrognathia and congenital heart disease. A conventional cytogenetic technique was applied for the diagnosis of the polysomy X, and quantitative fluorescent polymerase chain reaction (QF-PCR using 11 inherited short tandem repeat (STR alleles specific to the chromosome X for the determination of parental origin of X chromosomes. A cytogenetic evaluation revealed that the karyotype of the infant was 49,XXXXX. Comparison of the infant’s features with previously reported cases indicated a clinically recognizable specific pattern of malformations referred to as the pentasomy X syndrome. However, to the best of our know-ledge, this is the first report of thenar atrophy in a patient with 49,XXXXX. The molecular analysis suggested that four X chromosomes of the infant originated from the mother as a result of the non disjunction events in meiosis I and meiosis II. We here state that the clinical manifestations seen in our case were consistent with those described previously in patients with pentasomy X. The degree of early hypotonia constitutes an important early prognostic feature in this syndrome. The pathogenesis of pentasomy X is not clear at present, but it is thought to be caused by successive maternal non disjunctions.

  19. Clinical effects of acupuncture therapy for vascular dementia

    Institute of Scientific and Technical Information of China (English)

    Lei Zhao; Yi Guo; Jun Xiong; Wei Wang; Yuanhao Du; Lijuan Yan

    2011-01-01

    revealed efficacy at different aspects of acupuncture and moxibustion, which was superior to the conventional body acupuncture group(risk ratio(RR)=0.03,95% CI: 0.01-0.18, P<0.01; RR=0.05, 95% CI: 0.07-0.13, P<0.05). One A-level evidence study demonstrated that acupuncture improved mental state, daily living activities, and efficacy and effect of cognitive aspects, which was superior to the drug group[cognitive effects(RR = 5.92, 95% CI:2.66-13.16, P<0.01); activities of daily living efficacy(RR= 3.00, 95% CI:1.57-5.75, P<0.01)].The Mini Mental State Examination score resulted in the following: WMD = 3.85, 95% CI:1.63-6.07,P<0.01. One B-grade evidence article revealed that laser irradiation combined with electro-acupuncture was more effective than simple drug treatment(RR = 10.43, 95% CI:1.22-89.46, P<0.05).CONCLUSION: The inclusion of limited clinical studies has verified the efficacy of acupuncture in vascular dementia treatment. Acupuncture or its combination with Chinese herbs provides certain advantages, but most clinical studies have a small sample size. Large sample size, randomized,controlled trials are needed in the future for more definitive results.

  20. Thermal effects on bluegill hematology. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Murray, S.A.

    1983-03-01

    Temperature effects on hematological responses of adult bluegill were examined for constant vs fluctuating temperature regimes, for ambient vs high temperature, and for intake vs discharge at an operating power plant. Multivariate statistical methods were used to determine temperature effects. An increased erythrocyte fragility was associated with fluctuating temperature regimes as well as with the suboptimal temperature regime. Thrombocytosis with a concomitant leukopenia was observed for the higher fluctuating and higher acclimating temperatures. Reduced erythrocytic sedimentation rates were observed for the higher temperatures. Although hematology may vary depending on fish size, good hematological indicators of potential thermal stress were associated with red blood cell morphology, particularly cell size and/or shape. However, in situ hematological responses of bluegill at an operating power plant were apparently not affected by the associated thermal gradients.