WorldWideScience

Sample records for clinical evaluation study

  1. An Evaluative Study of Clinical Preceptorship.

    Science.gov (United States)

    Kaviani, Nayer; Stillwell, Yvonne

    2000-01-01

    A training institute to prepare nurses to serve as preceptors of undergraduate clinical experience was evaluated by focus groups of 6 preceptors, 13 students, and 2 nurse managers. Formal preceptorship training enhanced student learning and promoted positive relationships between nurse educators and practitioners. (SK)

  2. A systematic review of clinical supervision evaluation studies in nursing.

    Science.gov (United States)

    Cutcliffe, John R; Sloan, Graham; Bashaw, Marie

    2018-02-15

    According to the international, extant literature published during the last 20 years or so, clinical supervision (CS) in nursing is now a reasonably common phenomenon. Nevertheless, what appears to be noticeably 'thin on the ground' in this body of literature are empirical evaluations of CS, especially those pertaining to client outcomes. Accordingly, the authors undertook a systematic review of empirical evaluations of CS in nursing to determine the state of the science. Adopting the approach documented by Stroup et al. (JAMA, 283, 2000, 2008), the authors searched for reports of evaluation studies of CS in nursing - published during the years 1995 to 2015. Keywords for the search were 'clinical supervision', 'evaluation', 'efficacy', 'nursing', and combinations of these keywords. Electronic databases used were CINAHL, MEDLINE, PsychLIT, and the British Nursing Index. The research evidence from twenty-eight (28) studies reviewed is presented, outlining the main findings with an overview of each study presented. The following broad themes were identified and are each discussed in the study: narrative/anecdotal accounts of positive outcomes for clinical supervision, narrative/anecdotal accounts of negative outcomes for clinical supervision, empirical positive outcomes reported by supervisee, and empirical findings showing no effect by supervisee. © 2018 Australian College of Mental Health Nurses Inc.

  3. Clinical study of Whole Heart MRCA. Evaluation of acquisition method

    International Nuclear Information System (INIS)

    Iwai, Mitsuhiro; Tateishi, Toshiki; Takeda, Soji; Hayashi, Ryuji

    2006-01-01

    In CT coronary angiography (CTCA), image reconstruction is performed using the optimal phase with either the relative or the absolute delaying methods. Whole Heart MRCA is generally considered to set up the signal acquisition time when is only the middle-diastolic phase in the standstill state of the right coronary artery per cardiac beat as the conventional method. However, in the case of high cardiac beats, such as arrhythmia respiratory instability, etc., image acquisition can take long time and a good quality image may not be maintained. We use not only the middle-diastolic acquisition (conventional method) but also the systolic phase acquisition (systolic phase method) and the shortening method (total acquisition shortening (TASH) method). The aim of this study was to examine the depiction ability and the image quality in the images of 585 Whole Heart MRCA(s) acquired by three methods described above. Seventy percent of all exhibited good quality images in the middle of extension. The remaining images obtained by the systolic phase (at the time of high cardiac beats) and the TASH methods (respiratory instability etc.) were better than those obtained using the conventional method. The sensitivity and the specificity of coronary stenosis (75%) in the TASH, systolic-phase and the conventional methods were 90% and 96%, 96% and 97%, and 87% and 96%, respectively. These findings proved that no significant differences in the depiction of the coronary stenosis were apparent using the three methods. It was concluded that it was necessary to establish suitable signal time acquisition and to change the acquisition method depending on cardiac beats or the state of breathing for Whole Heart MRCA. (author)

  4. Challenges in Evaluating Clinical Governance Systems in Iran: A Qualitative Study

    Science.gov (United States)

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Background: In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. Objectives: This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. Materials and Methods: For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Results: Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Conclusions: Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead. PMID:24910799

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

    Science.gov (United States)

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

    2015-01-01

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

  6. Healthcare students' evaluation of the clinical learning environment and supervision - a cross-sectional study.

    Science.gov (United States)

    Pitkänen, Salla; Kääriäinen, Maria; Oikarainen, Ashlee; Tuomikoski, Anna-Maria; Elo, Satu; Ruotsalainen, Heidi; Saarikoski, Mikko; Kärsämänoja, Taina; Mikkonen, Kristina

    2018-03-01

    The purpose of clinical placements and supervision is to promote the development of healthcare students´ professional skills. High-quality clinical learning environments and supervision were shown to have significant influence on healthcare students´ professional development. This study aimed to describe healthcare students` evaluation of the clinical learning environment and supervision, and to identify the factors that affect these. The study was performed as a cross-sectional study. The data (n = 1973) were gathered through an online survey using the Clinical Learning Environment, Supervision and Nurse Teacher scale during the academic year 2015-2016 from all healthcare students (N = 2500) who completed their clinical placement at a certain university hospital in Finland. The data were analysed using descriptive statistics and binary logistic regression analysis. More than half of the healthcare students had a named supervisor and supervision was completed as planned. The students evaluated the clinical learning environment and supervision as 'good'. The students´ readiness to recommend the unit to other students and the frequency of separate private unscheduled sessions with the supervisor were the main factors that affect healthcare students` evaluation of the clinical learning environment and supervision. Individualized and goal-oriented supervision in which the student had a named supervisor and where supervision was completed as planned in a positive environment that supported learning had a significant impact on student's learning. The clinical learning environment and supervision support the development of future healthcare professionals' clinical competence. The supervisory relationship was shown to have a significant effect on the outcomes of students' experiences. We recommend the planning of educational programmes for supervisors of healthcare students for the enhancement of supervisors' pedagogical competencies in supervising students in

  7. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    Science.gov (United States)

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

  8. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

    universities and practicing dentists restore millions of teeth throughout the World with composite resin materials. Do we know enough about the clinical performance of these restorations over time? Numerous in vitro studies are being published on resin materials and adhesion, some of them attempting to imitate...... in vivo conditions. But real life is different and in vitro studies cannot include all variables. Only clinical studies can provide valid information on the clinical performance of restorations over time. What do we know about longevity of posterior resin restorations? What are the reasons for replacement...... and results from own up to 30-year prospective clinical university studies and practice based studies from Public Dental Health Service on the clinical performance of posterior composite resin restorations....

  9. Magnetic resonance imaging in the evaluation of clinical treatment of otospongiosis: a pilot study.

    Science.gov (United States)

    de Oliveira Vicente, Andy; Chandrasekhar, Sujana S; Yamashita, Helio K; Cruz, Oswaldo Laercio M; Barros, Flavia A; Penido, Norma O

    2015-06-01

    To evaluate the applicability of magnetic resonance imaging (MRI) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment. Prospective, randomized, controlled, double-blind study. One single tertiary care institution in a large, cosmopolitan city. Twenty-six patients (n = 42 ears) with clinical, audiometric, and tomographic diagnosis of otosclerosis were enrolled. If computed tomography (CT) demonstrated active lesions, these patients underwent MRI to detect otospongiotic foci, seen as areas of gadolinium enhancement. Patients were divided into 3 groups and received treatment with placebo, sodium alendronate, or sodium fluoride for 6 months. After this period, clinical and audiometric evaluations and a second MRI were performed. Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective (visual) and objective (using specific eFilm Workstation software) manner. Otospongiosis was most predominantly identified in the region anterior to the oval window, and this site was reliable for comparing pre- and posttreatment scans. The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions, more relevant in the alendronate group. These findings were statistically significant for both subjective and objective MRI evaluations. MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis. The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

  10. Implementation and Evaluation of a Clinical Pathway for Pancreaticoduodenectomy Procedures: a Prospective Cohort Study

    NARCIS (Netherlands)

    Kolk, M. van der; Boogaard, M.H.W.A. van den; Becking-Verhaar, F.; Custers, H.; Hoeven, H. van der; Pickkers, P.; Laarhoven, K. van

    2017-01-01

    INTRODUCTION: Medical and nursing protocols in perioperative care for pancreaticoduodenectomy are mainly mono-disciplinary, limiting their integration and transparency in a continuous health care system. The aims of this study were to evaluate adherence to a multidisciplinary clinical pathway for

  11. Clinical evaluation of a newly designed orthodontic tooth brush - A clinical study

    Directory of Open Access Journals (Sweden)

    C S Saimbi

    2009-01-01

    In this study, the newly designed orthodontic tooth brush is compared with an ordinary tooth brush. Results of this study show that the newly designed orthodontic tooth brush is superior in its cleaning efficiency as compared to the ordinary tooth brush. The results show that plaque removing capacity of orthodontic tooth brush is nearly 95-99%.

  12. Evaluation of dental restorations: a comparative study between clinical and digital photographic assessments.

    Science.gov (United States)

    Moncada, G; Silva, F; Angel, P; Oliveira, O B; Fresno, M C; Cisternas, P; Fernandez, E; Estay, J; Martin, J

    2014-01-01

    The aim of this study was to compare the efficacy of a direct clinical evaluation method with an indirect digital photographic method in assessing the quality of dental restorations. Seven parameters (color, occlusal marginal adaptation, anatomy form, roughness, occlusal marginal stain, luster, and secondary caries) were assessed in 89 Class I and Class II restorations from 36 adults using the modified US Public Health Service/Ryge criteria. Standardized photographs of the same restorations were digitally processed by Adobe Photoshop software, separated into the following four groups and assessed by two calibrated examiners: Group A: The original photograph displayed at 100%, without modifications (IMG100); Group B: Formed by images enlarged at 150% (IMG150); Group C: Formed by digital photographs displayed at 100% (mIMG100), with digital modifications (levels adjustment, shadow and highlight correction, color balance, unsharp Mask); and Group D: Formed by enlarged photographs displayed at 150% with modifications (mIMG150), with the same adjustments made to Group C. Photographs were assessed on a calibrated screen (Macbook) by two calibrated clinicians, and the results were statistically analyzed using Wilcoxon tests (SSPS 11.5) at 95% CI. The photographic method produced higher reliability levels than the direct clinical method in all parameters. The evaluation of digital images is more consistent with clinical assessment when restorations present some moderate defect (Bravo) and less consistent when restorations are clinically classified as either satisfactory (Alpha) or in cases of severe defects (Charlie). The digital photographic method is a useful tool for assessing the quality of dental restorations, providing information that goes unnoticed with the visual-tactile clinical examination method. Additionally, when analyzing restorations using the Ryge modified criteria, the digital photographic method reveals a significant increase of defects compared to those

  13. Validity and Reliability of the Clinical Competency Evaluation Instrument for Use among Physiotherapy Students: Pilot study.

    Science.gov (United States)

    Muhamad, Zailani; Ramli, Ayiesah; Amat, Salleh

    2015-05-01

    The aim of this study was to determine the content validity, internal consistency, test-retest reliability and inter-rater reliability of the Clinical Competency Evaluation Instrument (CCEVI) in assessing the clinical performance of physiotherapy students. This study was carried out between June and September 2013 at University Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia. A panel of 10 experts were identified to establish content validity by evaluating and rating each of the items used in the CCEVI with regards to their relevance in measuring students' clinical competency. A total of 50 UKM undergraduate physiotherapy students were assessed throughout their clinical placement to determine the construct validity of these items. The instrument's reliability was determined through a cross-sectional study involving a clinical performance assessment of 14 final-year undergraduate physiotherapy students. The content validity index of the entire CCEVI was 0.91, while the proportion of agreement on the content validity indices ranged from 0.83-1.00. The CCEVI construct validity was established with factor loading of ≥0.6, while internal consistency (Cronbach's alpha) overall was 0.97. Test-retest reliability of the CCEVI was confirmed with a Pearson's correlation range of 0.91-0.97 and an intraclass coefficient correlation range of 0.95-0.98. Inter-rater reliability of the CCEVI domains ranged from 0.59 to 0.97 on initial and subsequent assessments. This pilot study confirmed the content validity of the CCEVI. It showed high internal consistency, thereby providing evidence that the CCEVI has moderate to excellent inter-rater reliability. However, additional refinement in the wording of the CCEVI items, particularly in the domains of safety and documentation, is recommended to further improve the validity and reliability of the instrument.

  14. Usefulness of myocardial parametric imaging to evaluate myocardial viability in experimental and in clinical studies.

    Science.gov (United States)

    Korosoglou, G; Hansen, A; Bekeredjian, R; Filusch, A; Hardt, S; Wolf, D; Schellberg, D; Katus, H A; Kuecherer, H

    2006-03-01

    To evaluate whether myocardial parametric imaging (MPI) is superior to visual assessment for the evaluation of myocardial viability. Myocardial contrast echocardiography (MCE) was assessed in 11 pigs before, during, and after left anterior descending coronary artery occlusion and in 32 patients with ischaemic heart disease by using intravenous SonoVue administration. In experimental studies perfusion defect area assessment by MPI was compared with visually guided perfusion defect planimetry. Histological assessment of necrotic tissue was the standard reference. In clinical studies viability was assessed on a segmental level by (1) visual analysis of myocardial opacification; (2) quantitative estimation of myocardial blood flow in regions of interest; and (3) MPI. Functional recovery between three and six months after revascularisation was the standard reference. In experimental studies, compared with visually guided perfusion defect planimetry, planimetric assessment of infarct size by MPI correlated more significantly with histology (r2 = 0.92 versus r2 = 0.56) and had a lower intraobserver variability (4% v 15%, p < 0.05). In clinical studies, MPI had higher specificity (66% v 43%, p < 0.05) than visual MCE and good accuracy (81%) for viability detection. It was less time consuming (3.4 (1.6) v 9.2 (2.4) minutes per image, p < 0.05) than quantitative blood flow estimation by regions of interest and increased the agreement between observers interpreting myocardial perfusion (kappa = 0.87 v kappa = 0.75, p < 0.05). MPI is useful for the evaluation of myocardial viability both in animals and in patients. It is less time consuming than quantification analysis by regions of interest and less observer dependent than visual analysis. Thus, strategies incorporating this technique may be valuable for the evaluation of myocardial viability in clinical routine.

  15. Evaluation of complementary-alternative medicine (CAM) questionnaire development for Indonesian clinical psychologists: A pilot study.

    Science.gov (United States)

    Liem, Andrian; Newcombe, Peter A; Pohlman, Annie

    2017-08-01

    This study aimed to evaluate questionnaire development to measure the knowledge of Complementary-Alternative Medicine (CAM), attitudes towards CAM, CAM experiences, and CAM educational needs of clinical psychologists in Indonesia. A 26-item questionnaire was developed through an extensive literature search. Data was obtained from provisional psychologists from the Master of Professional Clinical Psychology programs at two established public universities in urban areas of Indonesia. To validate the questionnaire, panel reviews by executive members of the Indonesian Clinical Psychology Association (ICPA), experts in health psychology, and experts in public health and CAM provided their professional judgements. The self-reporting questionnaire consisted of four scales including: knowledge of CAM (6 items), attitudes towards CAM (10 items), CAM experiences (4 items), and CAM educational needs (6 items). All scales, except CAM Experiences, were assessed on a 7-point Likert scale. Sixty provisional psychologists were eligible to complete the questionnaire with a response rate of 73% (N=44). The results showed that the CAM questionnaire was reliable (Cronbach's coefficient alpha range=0.62-0.96; item-total correlation range=0.14-0.92) and demonstrated content validity. Following further psychometric evaluation, the CAM questionnaire may provide the evidence-based information to inform the education and practice of Indonesian clinical psychologists. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Using a finite element pediatric hip model in clinical 2 evaluation - a feasibility study

    DEFF Research Database (Denmark)

    Skytte, T. L.; Mikkelsen, Lars Pilgaard; Sonne-Holm, Stig

    2017-01-01

    The paper describe a method to construct a finite element model of the hip joint of a child based on clinical recorded CT data. A model which can be used for diagnostic aid and pre-operative surgical evaluation. First part of this development is a feasibility study of this method. A scan...... to previous published experimental studies and computational models investigating the adult hip joint. Good correlation between the current model and previous models were found. The current case specific modeling technique may be a useful complement to the previously developed hip models....

  17. Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

    Science.gov (United States)

    Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

    2015-06-01

    National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

  18. Usability Evaluation of Electronic Health Record System around Clinical Notes Usage-An Ethnographic Study.

    Science.gov (United States)

    Rizvi, Rubina F; Marquard, Jenna L; Hultman, Gretchen M; Adam, Terrence J; Harder, Kathleen A; Melton, Genevieve B

    2017-10-01

    Background A substantial gap exists between current Electronic Health Record (EHR) usability and potential optimal usability. One of the fundamental reasons for this discrepancy is poor incorporation of a User-Centered Design (UCD) approach during the Graphical User Interface (GUI) development process. Objective To evaluate usability strengths and weaknesses of two widely implemented EHR GUIs for critical clinical notes usage tasks. Methods Twelve Internal Medicine resident physicians interacting with one of the two EHR systems (System-1 at Location-A and System-2 at Location-B) were observed by two usability evaluators employing an ethnographic approach. User comments and observer findings were analyzed for two critical tasks: (1) clinical notes entry and (2) related information-seeking tasks. Data were analyzed from two standpoints: (1) usability references categorized by usability evaluators as positive, negative, or equivocal and (2) usability impact of each feature measured through a 7-point severity rating scale. Findings were also validated by user responses to a post observation questionnaire. Results For clinical notes entry, System-1 surpassed System-2 with more positive (26% vs. 12%) than negative (12% vs. 34%) usability references. Greatest impact features on EHR usability (severity score pertaining to each feature) for clinical notes entry were: autopopulation (6), screen options (5.5), communication (5), copy pasting (4.5), error prevention (4.5), edit ability (4), and dictation and transcription (3.5). Both systems performed equally well on information-seeking tasks and features with greatest impacts on EHR usability were navigation for notes (7) and others (e.g., looking for ancillary data; 5.5). Ethnographic observations were supported by follow-up questionnaire responses. Conclusion This study provides usability-specific insights to inform future, improved, EHR interface that is better aligned with UCD approach.

  19. STRUCTURED CLINICAL EVALUATION

    Directory of Open Access Journals (Sweden)

    Arabela Maria Barbosa Sampaio

    2014-05-01

    Full Text Available In a world experiencing profound technological and socio-political changes in areas of knowledge and capacity, healthcare can not remain static. A new kind of professional is required, whose practice is based on ethics, scientific standards, integrity, citizenship, and health promotion, who develops skills beyond healthcare, such as decision making, communication,leadership, management, and continuing education. No single method can assess all of these elements (knowledge, skills, and attitudes, and only a combination of methods is able to produce a valid evaluation. An alternative method exists: structured clinical assessments based on observation of "to do, or how to do" that aim to complete this evaluation by focusing attention on the performance of specific skills. In order to broaden the scope of evaluation methods that have been used in health education, this article, a literature review, intends to offer readers an overview of the diverse types of structured clinical evaluation, emphasizing Objective Structured Clinical Examination, the most widely used in Brazil, with a goal of advancing opportunities for health professionals to make use of this evaluative tool.

  20. Clinical and computerized evaluation in study of temporo-mandibular joint intracapsular disease.

    Science.gov (United States)

    Ciavarella, D; Mastrovincenzo, M; Sabatucci, A; Parziale, V; Granatelli, F; Violante, F; Bossù, M; Lo Muzio, L; Chimenti, C

    2010-03-01

    In this work authors show a diagnostic criteria in study of TMID: neuro occlusal clinical evaluation (NOE), T-Scan 2 system and surface electromyography (sEMG). Nine patients 25-30 years old with TMID problem and 9 healthy group control have been selected and examined. On each patients it has been performed NOE, T-Scan and sEMG test. NOE has been calculated on each patient photos lateral mandibular excursion angle called: masticatory functional angle (AFM). T-Scan System is a computerized occlusal analyzer that provide in-depth understanding of the overall balance of the occlusion. At the same time of T-Scan record sEMG tests, in resting position and in maximum clench, have been performed. In healthy control there were no AFM difference. In no healthy group there were difference between the two AFM greater than 6 degrees. T-Scan COF showed how in healthy group control there was never a difference of COF greater than 5%. In no healthy group the difference were greater than 5% Pjoint sound than the balance side P<0.001. sEMG show how in TMID patients maximum masseter activation is always lower than maximum masseter activation of healthy subjects P<0.001. Neuro occlusal clinical evaluation (NOE) in TMID patients is supported by instrumental evaluation.

  1. Clinical observed performance evaluation: a prospective study in final year students of surgery.

    LENUS (Irish Health Repository)

    Markey, G C

    2010-06-24

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series of assessments in a 25-week teaching programme. Over time, several clinicians from a pool of 16 surgical consultants and registrars evaluated each student by direct observation. A structured rating form was used for assessment data. Variance component analysis (VCA), internal consistency and inter-rater agreement were used to estimate reliability. The predictive and convergent validity of COPE in relation to summative OSCE, long case, and overall final examination was estimated. Median number of COPE assessments per student was 7. Generalisability of a mean score over 7 COPE assessments was 0.66, equal to that of an 8 x 7.5 min station final OSCE. Internal consistency was 0.88-0.97 and inter-rater agreement 0.82. Significant correlations were observed with OSCE performance (R = 0.55 disattenuated) and long case (R = 0.47 disattenuated). Convergent validity was 0.81 by VCA. Overall final examination performance was linearly related to mean COPE score with standard error 3.7%. COPE permitted efficient serial assessment of a large cohort of final year students in a real world setting. Its psychometric quality compared well with conventional assessments and with other direct observation instruments as reported in the literature. Effect on learning, and translation to clinical care, are directions for future research.

  2. Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

    Science.gov (United States)

    Takahashi, K; Sengoku, S; Kimura, H

    2011-02-01

    A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

  3. [The effect of acupuncture in the treatment of insomnia. Clinical study of subjective and objective evaluation].

    Science.gov (United States)

    Montakab, H; Langel, G

    1994-01-01

    The sleep-wake cycle is the most important circadian rhythm in man and thus constitutes an excellent indicator of internal equilibrium and of health. Sleep disorders, and particularly insomnia, affect a great percentage of the population. In daily practice, an inappropriate treatment may transform a bad sleeper into an insomniac dependent on pharmaceuticals for life. It is therefore necessary to give priority to non-chemical treatments in the management of insomnia. Acupuncture, which offers a personalized treatment, is particularly indicated for reharmonizing a disturbed sleep-wake cycle. Furthermore, there is an interesting similarity between the 5000-year-old theoretical basis of Chinese medicine and the recent scientific discoveries about man's internal rhythms. Clinical and statistical studies of the effects of acupuncture on insomnia are rare and evaluate only the subjective appreciation of sleep. Objective analysis of sleep by polysomnography permits evaluation of sleep architecture and visualizes the site and depth of action of the therapeutic method. Such studies have only been conducted in relation to pharmaceutical treatments. No such study has been carried out for acupuncture. A scientific and objective evaluation of the effects of acupuncture on insomnia by polysomnography could be not only of academic but mainly of great practical interest. If the efficiency of acupuncture is thus verified, this method could be integrated and proposed along with other classical therapeutic technics.

  4. Clinical evaluation of marketed orthodontic products: are researchers behind the times? A meta-epidemiological study

    Directory of Open Access Journals (Sweden)

    Jadbinder Seehra

    2017-05-01

    Full Text Available Abstract Background The role of marketing and industry in the treatment decisions of orthodontists has received increasing attention in recent years with clinical research typically undertaken subsequent to established use of these devices and often failing to confirm the promise of manufacturers’ claims. This meta-epidemiological study was undertaken to assess the proportion of clinical trials in orthodontics evaluating commercially marketed products and to evaluate the direction of the results of these studies. Methods Electronic searching was undertaken to identify randomized controlled trials (RCTs published over a 5-year period (1 January 2012 to 31 December 2016. Data obtained included the type of marketed intervention, direction of effect and declaration of both industry sponsorship and conflict of interest. Results Eighty-four RCTs published in 23 scientific journals were included with the highest percentage in the American Journal of Dentofacial Orthopedics (AJO-DO (23.8%, followed by the European Journal of Orthodontics (EJO (14.3%, Journal of Orthodontics (JO (10.7% and Angle Orthodontist (AO (10.7%. Overall, 45% (38/84 of clinical trials assessed involved analysis of marketed products after their introduction. Interventions to improve oral health or circumvent the risk of iatrogenic damage, such as white spot lesions, were most commonly assessed (15.8%, with the relative merits of non-surgical adjuncts (14.1% and other orthodontic auxiliaries (13.1% also frequently evaluated. In 44% of RCTs, a positive effect of the marketed intervention was not reported. Industry sponsorship of the research was declared in 9.5% RCTs. No significant associations between the direction of the effect and both declaration of industry sponsorship (p = 0.56 and conflict of interest (p = 0.96 were detected. Moreover, for marketed and non-marketed products, no significant associations for both declaration of industry sponsorship (p = 0.44 and

  5. Evaluation of the Esthetic Properties of Developmental Defects of Enamel: A Spectrophotometric Clinical Study

    Directory of Open Access Journals (Sweden)

    Fabrizio Guerra

    2015-01-01

    Full Text Available Objectives. Detailed clinical quantification of optical properties of developmental defect of enamel is possible with spectrophotometric evaluation. Developmental defects of enamel (DDE are daily encountered in clinical practice. DDE are an alteration in quality and quantity of the enamel, caused by disruption and/or damage to the enamel organ during amelogenesis. Methods. Several clinical indices have been developed to categorize enamel defects based on their nature, appearance, microscopic features, or cause. A sample of 39 permanent teeth presenting DDE on labial surface was examined using the DDE Modified Index and SpectroShade evaluation. The spectrophotometric approach quantifies L* (luminosity, a* (quantity of green-red, and b* (quantity of blue-yellow of different DDE. Conclusions. SpectroShade evaluation of the optical properties of the enamel defect enhances clinical understanding of severity and extent of the defect and characterizes the enamel alteration in terms of color discrepancy and surface characterization.

  6. Evaluating clinical and public health interventions: a practical guide to study design and statistics

    National Research Council Canada - National Science Library

    Katz, Mitchell H

    2010-01-01

    .... Because the choice of research design depends on the nature of the intervention, the book covers randomized and nonrandomized designs, prospective and retrospective studies, planned clinical trials...

  7. Prospective study to evaluate the clinical and radiological outcome of patients with scleroderma of the face.

    Science.gov (United States)

    Careta, Mariana Figueiroa; Leite, Claudia da Costa; Cresta, Fernando; Albino, Jose; Tsunami, Mirian; Romiti, Ricardo

    2013-09-01

    Scleroderma featuring rare connective tissue disease that manifests as skin sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement and localized scleroderma or morphea which classically presents benign evolution and self-limited, confined to the skin and/or underlying tissue. Recent studies show that the localized form may possibly course with involvement of internal organs and variable morbidity. This study aimed to determine the demographic characteristics, the prevalence of systemic manifestations and laboratory findings, as well as the association with autoimmune diseases, and the evolution of neurological findings, both clinical as brain MRI in patients with scleroderma of the face and its relation with the activity skin. Patients with localized scleroderma with facial involvement were evaluated and underwent neurological examination, magnetic resonance imaging and ophthalmology evaluation. After 3years, the patients were subjected again to MRI. We studied 12 patients with localized scleroderma of the face. Of this total, headache being the most frequent complaint found in 66.7% of patients, 33.3% had neurological changes possibly associated with scleroderma. As for ophthalmologic evaluation, 25% of patients showed abnormalities. The most frequent parenchymal finding was the presence of lesions with hyperintense or hypointense signal in 75% of patients, followed by ventricular asymmetry at 16.7%. Of the patients who had neurological deficits, 75% also had a change to MRI. In all patients, imaging findings after 3years were unchanged. During this interval of 3years, 25% of patients showed signs of activity of scleroderma. Patients with localized scleroderma of the face have a high prevalence of neurological and ophthalmological changes. Based on these findings, we suggest that all cases of localized scleroderma of the face should be thoroughly

  8. Radiochemical studies, pre-clinical investigation and preliminary clinical evaluation of "1"7"0Tm-EDTMP prepared using in-house freeze-dried EDTMP kit

    International Nuclear Information System (INIS)

    Das, Tapas; Shinto, Ajit; Kamaleshwaran, Koramadai K.; Sarma, Haladhar D.; Mohammed, Sahiralam Khan; Mitra, Arpit; Lad, Sangita; Rajan, M.G.R.; Banerjee, Sharmila

    2017-01-01

    The objective of the present work is to formulate "1"7"0Tm-EDTMP using an in-house freeze-dried EDTMP kit and evaluate its potential as a bone pain palliation agent. Patient dose of "1"7"0Tm-EDTMP was prepared with high radiochemical purity using the lyophilized kit at room temperature within 15 min. Pre-clinical evaluation in normal Wistar rats revealed selective skeletal accumulation with extended retention. Preliminary clinical investigation in 8 patients with disseminated skeletal metastases exhibited selective uptake in the bone and retention therein for a long duration. - Highlights: • Formulation of patient dose of "1"7"0Tm-EDTMP using freeze-dried EDTMP kit. • Radiochemical studies and pre-clinical evaluation of the agent in animal model. • Clinical evaluation in eight cancer patients with disseminated skeletal metastases.

  9. Case study of evaluations that go beyond clinical outcomes to assess quality improvement diabetes programmes using the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE).

    Science.gov (United States)

    Paquette-Warren, Jann; Harris, Stewart B; Naqshbandi Hayward, Mariam; Tompkins, Jordan W

    2016-10-01

    Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real-world evaluation. Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real-world comprehensive evaluations in health care settings. The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub-steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built-in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale-up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

  10. A CLINICAL STUDY ON SURGICAL MANAGEMENT OF TIBIAL PLATEAU FRACTURES - FUNCTIONAL AND RADIOLOGICAL EVALUATION

    Directory of Open Access Journals (Sweden)

    Bhavani

    2015-10-01

    Full Text Available BACKGROUND: Tremendous advance in mechanization and fastness of travel have been accompanied by steep increase in number and severity of fractures and those of tibial plateau are no exception. Knee being one of the major weight bearing joints of the body, fractures around it will be of paramount importance. AIM OF STUDY: This study is to analyze the functional outcome of CRIF or ORIF with or without bone grafting in tibial plateau fractures in adults. MATERIALS AND METHODS: 30 cases of tibial plateau fractures treated by various modalities were studied from 1 - 8 - 2012 to 31 - 1 - 2014 at our institution and followed for a minimum of 6 months. Fractures were evaluated using Modified Rasmussen’s Clinical, Radiological grading system. RESULTS : The selected patients were evaluated thoroughly and after the relevant investigations, were taken for surgery. The fractures were classified as per the SCHATZKER’S types and operated accordingly with CRIF with Percutaneous cannulated cancellous screws, ORIF with buttress plate/LCP with or without bone grafting. Immobilization of fractures continued for 3 weeks by POP slab. Early range of motion was then started. Weight bearing up to 6 - 8 weeks was not allowed. The full weight bearing deferred until 12 weeks or complete fracture union . The knee range of motion was excellent to very good, gait and weight bearing after complete union was satisfactory, knee stiffness in 3 cases , wound dehiscence and infection in 1 case and non - union in none of our cases was noted. CONCLUSION: Functional outcome is better in operatively treated tibial plateau fractures in adults, because it gives excellent anatomical reduction and rigid fixation to restore articular congruity and early motion thereby preventing knee stiffness.

  11. Clinical Evaluation of Radionuclide Esophageal Transit Studies using Liquid and Solid Foods

    Energy Technology Data Exchange (ETDEWEB)

    Choe, Jae Gol; Lee, Min Jae; Song, Chi Wook; Hyun, Jin Hai; Suh, Won Hyuck [Korea University College of Medicine, Seoul (Korea, Republic of)

    1995-03-15

    The author performed radionuclide esophageal transit studies(RETS) with liquid and solid boluses using the same day protocol in 90 normal controls and 164 patients with various primary esophageal motility disorders who were diagnosed by manometric criteria and clinical courses. The authors calculated mean esophageal transit time(MTT) and mean residual retention(MRR) in each of the liquid and solid studies, and classified time-activity curve(TAC) patterns. The normal criteria of RETS with liquid bolus were MTT<24 sec, MRR<9%, and the TAC pattern that showed rapid declining slope and flat low residual(Type 1). The normal criteria of RETS with solid bolus were MTT<35 sec, MRR<9% and TAC of type 1. With these normal criteria, the sensitivity and the specificity of the liquid study were 62.2% and 97.8%, respectively. The sensitivity increased to 75.4% with the solid study. The author also found that the RETS was highly reproducible. The achalasia typically showed no effective emptying of both liquid and solid boluses during the whole study period, and was well differentiated by its extremely long transit time and high retention from the other motility disorders. The diffuse esophageal spasm(DES) and nonspecific esophageal motility disorder(NEMD) showed intermediate delay in transit time and increased retention. In the groups of hypertensive lower esophageal sphincter(LES), hypotensive LES and nutcracker, there noted no significant difference with the normal control group in terms of MTT and MRR. The DES and NEMD could be more easily identified by solid studies that showed more marked delay in MTT and increased MRR as compared with the liquid study. In conclusion, esophageal scintigraphy is a safe, noninvasive and physiologic method for the evaluation of esophageal emptying.

  12. Clinical Evaluation of Small Diameter Straumann Implants in Partially Edentulous Patients: A 5-Year Retrospective Study

    Directory of Open Access Journals (Sweden)

    S. OZER

    2011-06-01

    Full Text Available Objective: The aim of the present study was to retrospectively evaluate small-diameter (3.3 mm Straumann® dental implants placed in the maxilla or the mandible over a period of 5 years in function.Materials and Methods: Twenty- eight partially edentulous patients received a total of 48 implants over a 5-year period. After the standard healing period (3 to 6 months, the implants were restored with single-tooth prostheses or fixed partial dentures. All patients were followed according to a strict maintenance program with regular recalls. The cumulative survival rates of implants were analyzed and prosthetic complications were assessed.Results: After 5 years of function, one single 10-mm-long implant in the maxillary premolar region was lost because of recurrent peri-implant infection in a female patient. Two single 10-mm-long maxillary implants placed in the posterior region were lost due to body fracture. The cumulative 5-year survival rate of the implants was 93.75 %. The most common prosthetic complication was loosening of the occlusal screw.Conclusion: Within the limited observation period and the number of patients included in this study, it may be concluded that the use of small-diameter implants appears to be predictable if clinical guidelines are followed and appropriate prosthetic restorations are provided. However, it should be noted that fatigue fracture may occur.

  13. Clinical evaluation of the use of a multifunctional remotely controlled insulin pump: multicenter observational study.

    Science.gov (United States)

    Boizel, Robert; Pinget, Michel; Lachgar, Karim; Parkin, Christopher G; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-11-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system's advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. © 2014 Diabetes Technology Society.

  14. Accuracy evaluation of intraoral optical impressions: A clinical study using a reference appliance.

    Science.gov (United States)

    Atieh, Mohammad A; Ritter, André V; Ko, Ching-Chang; Duqum, Ibrahim

    2017-09-01

    Trueness and precision are used to evaluate the accuracy of intraoral optical impressions. Although the in vivo precision of intraoral optical impressions has been reported, in vivo trueness has not been evaluated because of limitations in the available protocols. The purpose of this clinical study was to compare the accuracy (trueness and precision) of optical and conventional impressions by using a novel study design. Five study participants consented and were enrolled. For each participant, optical and conventional (vinylsiloxanether) impressions of a custom-made intraoral Co-Cr alloy reference appliance fitted to the mandibular arch were obtained by 1 operator. Three-dimensional (3D) digital models were created for stone casts obtained from the conventional impression group and for the reference appliances by using a validated high-accuracy reference scanner. For the optical impression group, 3D digital models were obtained directly from the intraoral scans. The total mean trueness of each impression system was calculated by averaging the mean absolute deviations of the impression replicates from their 3D reference model for each participant, followed by averaging the obtained values across all participants. The total mean precision for each impression system was calculated by averaging the mean absolute deviations between all the impression replicas for each participant (10 pairs), followed by averaging the obtained values across all participants. Data were analyzed using repeated measures ANOVA (α=.05), first to assess whether a systematic difference in trueness or precision of replicate impressions could be found among participants and second to assess whether the mean trueness and precision values differed between the 2 impression systems. Statistically significant differences were found between the 2 impression systems for both mean trueness (P=.010) and mean precision (P=.007). Conventional impressions had higher accuracy with a mean trueness of 17.0

  15. Design of a Competency Evaluation Model for Clinical Nursing Practicum, Based on Standardized Language Systems: Psychometric Validation Study.

    Science.gov (United States)

    Iglesias-Parra, Maria Rosa; García-Guerrero, Alfonso; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; León-Campos, Álvaro; Morales-Asencio, José Miguel

    2015-07-01

    To develop an evaluation system of clinical competencies for the practicum of nursing students based on the Nursing Interventions Classification (NIC). Psychometric validation study: the first two phases addressed definition and content validation, and the third phase consisted of a cross-sectional study for analyzing reliability. The study population was undergraduate nursing students and clinical tutors. Through the Delphi technique, 26 competencies and 91 interventions were isolated. Cronbach's α was 0.96. Factor analysis yielded 18 factors that explained 68.82% of the variance. Overall inter-item correlation was 0.26, and total-item correlation ranged between 0.66 and 0.19. A competency system for the nursing practicum, structured on the NIC, is a reliable method for assessing and evaluating clinical competencies. Further evaluations in other contexts are needed. The availability of standardized language systems in the nursing discipline supposes an ideal framework to develop the nursing curricula. © 2015 Sigma Theta Tau International.

  16. Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

    Science.gov (United States)

    Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

    2014-11-01

    The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014

  17. [Efficacy and Safety Evaluation of Bushen Shuji Granule in Treating Ankylosing Spondylitis Patients: a Clinical Study].

    Science.gov (United States)

    Kong, Wei-ping; Tao, Qing-wen; Zhang, Ying-ze; Yang, Shu; Xu, Yuan; Zhu, Xiao-xia; Jin, Yue; Yang, Wen-xue; Yan, Xiao-ping

    2015-06-01

    To evaluate the short-term efficacy and safety of Bushen Shuji Granule (BSG) in treating ankylosing spondylitis (AS) patients. A prospective randomized controlled clinical trial was carried out in 62 active stage AS patients with Shen deficiency Du-channel cold syndrome (SDDCS), who were randomly assigned to the BSG group (treated with BSG) and the control group (treated with Celecoxib Capsule). Twelve weeks consisted of one therapeutic course. Therapeutic effects were evaluated by ASAS20 and ASAS40 (set by Assessments in Ankylosing Spondylitis working group) , BASDA150, Chinese medical (CM) syndrome efficacy evaluation standards. BASDAI, the Bath Ankylosing Spondylitis Functional Index (BASFI), the Bath AS Metrology Index (BASMI), scores for spine pain, scores for pain at night, patient global assessment (PGA) , erythrocyte sedimentation rate (ESR) , and C reactive protein (CRP) were observed before and after treatment. After three-month treatment by BSG, ASAS20 standard rate was 63. 33% (19/30 cases) in the BSG group and 66.67% (20/30 cases) in the control group with no significant difference between the two groups (χ2 = 0.073, P > 0.05). The efficacy for CM syndromes was 70.00% (21/30 cases) in the BSG group, higher than that in the control group [40.00% (12/30 cases), χ2 = 5.455, P channel strengthening, blood activating, and channels dredging method had good short-term clinical efficacy and safety in treating AS.

  18. Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD

    DEFF Research Database (Denmark)

    Miravitlles, Marc; Sliwinski, Pawel; Rhee, Chin Kook

    2018-01-01

    BACKGROUND: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHOD: This international, multicenter, prospective study aimed to validate the concept of control in COPD [control = stability (no...... exacerbations or impairment in CAT scores) + low impact (low level of symptoms)]. Data from the screening visit was used to: investigate the level of control, compare characteristics of patients according to the control status, and perform a sensitivity analysis of the levels of control using either clinical...... criteria or questionnaires (COPD Assessment Test -CAT- or Clinical COPD Questionnaire -CCQ-). RESULTS: A total of 314 patients were analysed, mean age was 68.5 years and mean FEV1 was 52.6% of predicted. According to the prespecified criteria 21% of patients were classified as controlled, all of them...

  19. The Diagnosis of Urinary Tract Infection in Young Children (DUTY) Study Clinical Rule: Economic Evaluation.

    Science.gov (United States)

    Hollingworth, William; Busby, John; Butler, Christopher C; O'Brien, Kathryn; Sterne, Jonathan A C; Hood, Kerenza; Little, Paul; Lawton, Michael; Birnie, Kate; Thomas-Jones, Emma; Harman, Kim; Hay, Alastair D

    2017-04-01

    To estimate the cost-effectiveness of a two-step clinical rule using symptoms, signs and dipstick testing to guide the diagnosis and antibiotic treatment of urinary tract infection (UTI) in acutely unwell young children presenting to primary care. Decision analytic model synthesising data from a multicentre, prospective cohort study (DUTY) and the wider literature to estimate the short-term and lifetime costs and healthcare outcomes (symptomatic days, recurrent UTI, quality adjusted life years) of eight diagnostic strategies. We compared GP clinical judgement with three strategies based on a 'coefficient score' combining seven symptoms and signs independently associated with UTI and four strategies based on weighted scores according to the presence/absence of five symptoms and signs. We compared dipstick testing versus laboratory culture in children at intermediate risk of UTI. Sampling, culture and antibiotic costs were lowest in high-specificity DUTY strategies (£1.22 and £1.08) compared to clinical judgement (£1.99). These strategies also approximately halved urine sampling (4.8% versus 9.1% in clinical judgement) without reducing sensitivity (58.2% versus 56.4%). Outcomes were very similar across all diagnostic strategies. High-specificity DUTY strategies were more cost-effective than clinical judgement in the short- (iNMB = £0.78 and £0.84) and long-term (iNMB =£2.31 and £2.50). Dipstick tests had poorer cost-effectiveness than laboratory culture in children at intermediate risk of UTI (iNMB = £-1.41). Compared to GPs' clinical judgement, high specificity clinical rules from the DUTY study could substantially reduce urine sampling, achieving lower costs and equivalent patient outcomes. Dipstick testing children for UTI is not cost-effective. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  20. Evaluating clinical and public health interventions: a practical guide to study design and statistics

    National Research Council Canada - National Science Library

    Katz, Mitchell H

    2010-01-01

    ... and observational studies. In addition to reviewing standard statistical analysis, the book has easy-to-follow explanations of cutting edge techniques for evaluating interventions, including propensity score analysis...

  1. Evaluation of the clinical process in a critical care information system using the Lean method: a case study

    Directory of Open Access Journals (Sweden)

    Yusof Maryati Mohd

    2012-12-01

    Full Text Available Abstract Background There are numerous applications for Health Information Systems (HIS that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS, known as IntelliVue Clinical Information Portfolio (ICIP, and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

  2. Clinical and histological evaluation of thermal injury thresholds in human teeth: a preliminary study.

    Science.gov (United States)

    Baldissara, P; Catapano, S; Scotti, R

    1997-11-01

    The effect on healthy dental pulp of thermal increases ranging from 8.9 to 14.7 degrees C was evaluated. These temperature increases correspond approximately to those caused by certain restorative procedures, such as tooth preparation with high-speed instruments and the fabrication of direct provisional crowns. Two criteria of evaluation have been used in conjunction, a clinical (symptomatic) and a histological one, to assert with greater precision potential damage to the pulp. The results suggest a low susceptibility of cells to heat, which does not appear to be a major factor of injury, at least in the short term. The main cause of postoperative inflammation or necrosis of the pulp is probably the injury of the dentine, a tissue in direct functional and physiological connection with the pulp.

  3. Five Steps to Successfully Implement and Evaluate Propensity Score Matching in Clinical Research Studies.

    Science.gov (United States)

    Staffa, Steven J; Zurakowski, David

    2018-01-09

    -matched data to compare outcomes among treatment groups.PSM is becoming an increasingly more popular statistical methodology in medical research. It often allows for improved evaluation of a treatment effect that may otherwise be invalid due to a lack of balance between the 2 treatment groups with regard to confounding variables. PSM may increase the level of evidence of a study and in turn increases the strength and generalizability of its results. Our step-by-step approach provides a useful strategy for anesthesiologists to implement PSM in their future research.

  4. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    Science.gov (United States)

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  5. Evaluation of the utility of temporal subtraction images in successive whole-body bone scans: a prospective clinical study

    International Nuclear Information System (INIS)

    Shiraishi, J.; Appelbaum, D.; Pu, Y.; Engelmann, R.; Li Qiang; Doi, K.

    2007-01-01

    We have begun a prospective clinical study for evaluating the clinical utility of temporal subtraction images in successive whole-body bone scans. The computerized temporal subtraction technique has been developed in order to highlight interval changes of abnormal lesions due to skeletal metastases, primary bone tumors, osteomyelitis, and fractures. In our initial preliminary results of the prospective study which was started on November 22, 2006 in our hospital, radiologists reported some interval changes which were not recognized in the initial standard readings, but were obvious when temporal subtraction images were viewed. The usefulness of the temporal subtraction images will be investigated in terms of its clinical utility by the prospective clinical study. (orig.)

  6. Comparative clinical evaluation of transcutaneous electrical nerve stimulator over conventional local anesthesia in children seeking dental procedures: A clinical study

    Directory of Open Access Journals (Sweden)

    M Varadharaja

    2014-01-01

    Full Text Available Aim: The aim of this study to evaluate the effectiveness of pain control by employing transcutaneous electrical nerve stimulator (TENS over conventional injectable local anesthesia for children requiring restorative procedures under rubber dam. Materials and Methods: The study design considered was the split mouth design, in experiment (right side, dental procedures under rubber dam was performed under TENS and in control (left side, dental procedures under rubber dam was performed under conventional injectable local anesthetic (LA. The level of comfort and discomfort experienced during TENS and conventional LA was determined using visual analog scale (VAS and heart rate. Result: Increase in mean heart rate associated with TENS (0.78% was significantly less compared to increase in heart rate with administration of conventional local anesthesia (11.78%. In VAS, the mean values for pain indicate that minimum pain was felt with TENS, which was closely followed by LA. Conclusion: TENS can offer many safer and psychological advantages and is a valuable alternative to conventional LA for children.

  7. Evaluation of palatal plate thickness of maxillary prosthesis on phonation- a comparative clinical study.

    Science.gov (United States)

    Zakkula, Srujana; B, Sreedevi; Anne, Gopinadh; Manne, Prakash; Bindu O, Swetha Hima; Atla, Jyothi; Deepthi, Sneha; Chaitanya A, Krishna

    2014-04-01

    Prosthodontic treatment involves clinical procedures which influence speech performance directly or indirectly. Prosthetic rehabilitation of missing teeth with partial or complete maxillary removable dentures influences the individual voice characteristics like Phonation, resonance etc. To evaluate the effect of Acrylic palatal plate thickness (1mm-3mm) of maxillary prosthesis on phonation. Twelve subjects were selected randomly between the age group of 20-25 years who have full complement of teeth and have no speech problems. Speech evaluation was done under four experimental conditions i.e. Without any experimental acrylic palatal plate (control), with experimental acrylic palatal plates of thickness 1 mm, 2 mm and 3 mm respectively. The speech material for phonation test consisted of Vowels sounds /a/, /i/, and /o/. Speech analysis to assess phonation was done using digital acoustic analysis (PRAAT software). The obtained results were statistically analyzed by One-way ANOVA and Tukey's multiple post-hoc for comparison of four experimental conditions with respect to different vowel sounds. Mean harmonics to noise ratio (HNR) values obtained for all the Experimental conditions did not show significant difference (p>0.05). In conclusion, an increase in the thickness of the acrylic palatal plate of maxillary prosthesis for about 1 mm - 3mm in complete or partial maxillary removable dentures resulted in no significant effect on phonation of vowel sounds /a/, /i/ and /o/. Increasing the thickness of the palatal plate from 1 mm to 3 mm has not shown any significant effect on the phonation.

  8. Study, development and clinical evaluation of a per-operative γ imager

    International Nuclear Information System (INIS)

    Menard, Laurent

    1999-01-01

    The precise localization and complete surgical ablation of tumors are one of the most important procedures in cancer treatment. In that context, the use, in operating room, of light hand-held detectors associated to radiopharmaceutical compounds for tumor labelling, plays a significant role in assisting surgeons in real-time detection of lesion. The POCI gamma imaging probe (Per-Operative Compact Imager), which is presented here, is precisely dedicated to improve the radio-guided operative cancer surgery efficiency by bringing a new tool discriminating between healthy and pathological tissues. To match the specifications of intra-operative detection, we chose to build our camera around an intensified position sensitive diode which appeared to be particularly suitable to achieve a high resolution small size imager. The optimal geometry of two gamma detection head modules, composed of parallel hole collimators and scintillation crystals, was then investigated by numerical simulations. From these technological solutions, a first prototype of POCI with a 24 mm diameter field of view has been developed. Its characterization has put forward a millimeter spatial resolution and a detection efficiency comparable to that of clinical gamma cameras and in agreement with the numerical predictions. Finally, in collaboration with Gustave Roussy, a first clinical evaluation of the POCI camera has been performed for sentinel ganglion pre-operative localization in patients afflicted by malignant melanomas or breast cancers. The preliminary results have already shown that the performances of POCI are compatible with intraoperative imaging purposes and suggest how this camera can boost the success rate of tumor removal surgeries for other cancerous diseases. (author)

  9. The evaluation of family functioning by the family assessment device: a systematic review of studies in adult clinical populations.

    Science.gov (United States)

    Staccini, Laura; Tomba, Elena; Grandi, Silvana; Keitner, Gabor I

    2015-03-01

    A large body of research, documenting the impact of a family's functioning on health outcomes, highlights the importance of introducing the evaluation of patients' family dynamics into clinical judgment. The Family Assessment Device (FAD) is a self-report questionnaire designed to assess specific dimensions of family functioning. This qualitative systematic review, which follows PRISMA guidelines, aimed to identify the FAD's clinimetric properties and to report the incremental utility of its inclusion in clinical settings. A thorough literature search was performed, using both computerized and manual searches, yielding a total of 148 studies that were included in this review. The FAD has been extensively used in a variety of research contexts. In the majority of studies it was able to discriminate between clinical populations and controls and among groups of patients with different illnesses. The FAD also showed good test-retest and concurrent reliability, and modest sensitivity to change after treatment. FAD-dysfunctional family functioning was related to several patient clinical outcomes, including lower recovery rates and adherence to treatment, longer recovery time, poorer quality of life, and increased risk of relapse and drop-out. The present review demonstrates that the FAD is a suitable instrument for the evaluation of family functioning both in clinical and research settings. © 2014 Family Process Institute.

  10. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2012-05-24

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Development Officer through the Director of the Clinical Science Research and Development Service on the... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  11. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-04-06

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  12. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

    Science.gov (United States)

    2013-11-22

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Development Officer through the Director of the Clinical Science Research and Development Service on the...

  13. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and.... The Committee advises the Chief Research and Development Officer through the Director of the Clinical...

  14. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-12-20

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  15. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-10-24

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  16. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2012-12-05

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... through the Director of the Clinical Science Research and Development Service on the relevance and...

  17. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2013-08-27

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

  18. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2011-11-29

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... Officer through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  19. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Science.gov (United States)

    2010-05-21

    ... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service; Cooperative... through the Director of the Clinical Science Research and Development Service on the relevance and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

  20. Factors influencing change in clinical practice: A qualitative evaluation of the implementation of the quality improvement in colonoscopy study.

    Science.gov (United States)

    Rajasekhar, Praveen T; Rees, Colin J; Nixon, Catherine; East, James E; Brown, Sally

    2016-01-01

    The quality improvement in colonoscopy study was a region wide service improvement study to improve adenoma detection rate at colonoscopy by implementing evidence into routine colonoscopy practice. Implementing evidence into clinical practice can be challenging. The purpose of this paper is to perform a qualitative interview study to evaluate factors that influenced implementation within the study. Semi-structured interviews were conducted with staff in endoscopy units taking part in the quality improvement in colonoscopy study, after study completion. Units and interviewees were purposefully sampled to ensure a range of experiences was represented. Interviews were conducted with 11 participants. Key themes influencing uptake of the quality improvement in colonoscopy evidence bundle included time, study promotion, training, engagement, positive outcomes and modifications. Areas within themes were increased awareness of quality in colonoscopy (QIC), emphasis on withdrawal time and empowerment of endoscopy nurses to encourage the use of quality measures were positive outcomes of the study. The simple, visible study posters were reported as useful in aiding study promotion. Feedback sessions improved engagement. Challenges included difficulty arranging set-up meetings and engaging certain speciality groups. This evaluation suggests that methods to implement evidence into clinical practice should include identification and empowerment of team members who can positively influence engagement, simple, visible reminders and feedback. Emphasis on timing of meetings and strategies to engage speciality groups should also be given consideration. Qualitative evaluations can provide important insights into why quality improvement initiatives are successful or not, across different sites.

  1. Seven-year retrospective clinical study evaluating efficacy of stainless steel mesh in mandibular fractures.

    Science.gov (United States)

    Chakraborty, Sudip; Ghosh, Samiran; Burman, Richi; Ray, Amit

    2011-10-01

    The use of titanium mesh in communited mandibular fractures has been substantially documented. However, the use of stainless steel mesh for routine fixation in mandibular fractures has not been widely reported. The aim of the present study was to evaluate the efficacy of stainless steel mesh for routine osteosynthesis of mandibular fractures. A total of 252 patients who had been diagnosed with 287 single or multiple mandibular fractures at Guru Nanak Institute of Dental Science and Research from 2002 to 2009 were selected for the present study. Those with condylar fractures and other maxillofacial injuries were excluded from the study. The patients were evaluated preoperatively, intraoperatively, and postoperatively at 1 day, 6 weeks, and 3 and 6 months. The local complications, occlusion (for static function), and chewing (for dynamic function) were evaluated postoperatively. The intraoperative time taken for implant fixation (from site exposure to fixation of the last screw) was 32 minutes. Of the 252 patients, 40 (15.8%) had local complications and 24 patients required implant removal. Of the 252 patients, 82% had bilaterally satisfactory occlusion according to the surgeon at 6 months postoperatively. Discomfort in chewing unilaterally or bilaterally was reported by 17% of the patients. The results of our study have shown that stainless steel mesh has acceptable complication rates and the ability to maintain occlusion and chewing postoperatively compared with the present standards of care of mandibular fractures using miniplates. The lower cost and versatile placement of screws were the principal advantages. However, placement near the mental foramen with an extraoral approach for certain sites is the primary disadvantage. Copyright © 2011 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  2. [Physician knowledge and attitudes on the clinical evaluation and treatment of resistant hypertension: The RESIST study].

    Science.gov (United States)

    Coca, A

    Resistant hypertension (RH) is associated with a high risk of cardiovascular and renal complications. The purpose of this study was to assess the knowledge and attitudes of Primary Care physicians, general medicine doctors, and clinical cardiologists on the management of this condition. A multicentre, descriptive, observational study based on an ad hoc questionnaire distributed to Primary Care physicians (n=1017) and general medicine physicians/clinical cardiologists (n=457). To establish the diagnosis of resistant hypertension, 69.1% of physicians confirm that systolic/diastolic blood pressure is above 140/90 mmHg, despite treatment. Furthermore, 64.9% only consider this diagnosis if the patient is treated with at least 3 medications, and 50.3% also requires that one of them is a thiazide diuretic (56.7% among specialists, P=.0004). To establish a definite diagnosis of true RH, 89.6% perform 24-h ambulatory blood pressure monitoring (93.3% of specialists, P=.0017), looking specifically for «white-coat» effect in 70.2% of cases. In addition, 79.3% verify that adherence to treatment is adequate. Between 87 and 95% of physicians indicate examinations to exclude causes of secondary hypertension. Up to 54.3% of physicians (71.3% specialists, P<.0001) consider adding a fourth drug and insisting on lifestyle interventions as a priority therapeutic measure. These data show that physician knowledge regarding the management of patients with RH is good. Interestingly, this knowledge is somewhat higher among specialists than among Primary Care physicians. Copyright © 2016 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.

  3. A clinical decision support system algorithm for intravenous to oral antibiotic switch therapy: validity, clinical relevance and usefulness in a three-step evaluation study.

    Science.gov (United States)

    Akhloufi, H; Hulscher, M; van der Hoeven, C P; Prins, J M; van der Sijs, H; Melles, D C; Verbon, A

    2018-04-26

    To evaluate a clinical decision support system (CDSS) based on consensus-based intravenous to oral switch criteria, which identifies intravenous to oral switch candidates. A three-step evaluation study of a stand-alone CDSS with electronic health record interoperability was performed at the Erasmus University Medical Centre in the Netherlands. During the first step, we performed a technical validation. During the second step, we determined the sensitivity, specificity, negative predictive value and positive predictive value in a retrospective cohort of all hospitalized adult patients starting at least one therapeutic antibacterial drug between 1 and 16 May 2013. ICU, paediatric and psychiatric wards were excluded. During the last step the clinical relevance and usefulness was prospectively assessed by reports to infectious disease specialists. An alert was considered clinically relevant if antibiotics could be discontinued or switched to oral therapy at the time of the alert. During the first step, one technical error was found. The second step yielded a positive predictive value of 76.6% and a negative predictive value of 99.1%. The third step showed that alerts were clinically relevant in 53.5% of patients. For 43.4% it had already been decided to discontinue or switch the intravenous antibiotics by the treating physician. In 10.1%, the alert resulted in advice to change antibiotic policy and was considered useful. This prospective cohort study shows that the alerts were clinically relevant in >50% (n = 449) and useful in 10% (n = 85). The CDSS needs to be evaluated in hospitals with varying activity of infectious disease consultancy services as this probably influences usefulness.

  4. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    Science.gov (United States)

    Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

    2011-01-01

    Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up. PMID:21586837

  5. Prospective Clinical Study to Evaluate Clinical Performance of a Powered Surgical Stapler in Video-assisted Thoracoscopic Lung Resections

    DEFF Research Database (Denmark)

    Licht, Peter B; Ribaric, Goran; Crabtree, Traves

    2015-01-01

    Video-assisted thoracic surgery (VATS) research often focuses on postoperative air leak, with special consideration for prolonged air leak. There is limited clinical data regarding how stapling devices might affect performance and postoperative outcomes, including air leak. This prospective...... of postoperative air leaks, including prolonged air leak. Additional data collected included intraoperative details and postoperative outcomes. Prolonged air leak occurred in 22 subjects (10.3%) across procedures (152 lobectomies, 63 wedge resections, and 11 occurrences of wedge resection plus lobectomy......). There were no significant differences in occurrence or duration of PAL between the U.S. and Europe. Regional differences were observed for intraoperative leak testing and cartridge selection relative to tissue type. Despite differences in surgical technique between continents, no major or significant...

  6. Evaluation of an artificial intelligence guided inverse planning system: Clinical case study

    International Nuclear Information System (INIS)

    Yan Hui; Yin Fangfang; Willett, Christopher

    2007-01-01

    Purpose: An artificial intelligence (AI) guided method for parameter adjustment of inverse planning was implemented on a commercial inverse treatment planning system. For evaluation purpose, four typical clinical cases were tested and the results from both plans achieved by automated and manual methods were compared. Methods and materials: The procedure of parameter adjustment mainly consists of three major loops. Each loop is in charge of modifying parameters of one category, which is carried out by a specially customized fuzzy inference system. A physician prescribed multiple constraints for a selected volume were adopted to account for the tradeoff between prescription dose to the PTV and dose-volume constraints for critical organs. The searching process for an optimal parameter combination began with the first constraint, and proceeds to the next until a plan with acceptable dose was achieved. The initial setup of the plan parameters was the same for each case and was adjusted independently by both manual and automated methods. After the parameters of one category were updated, the intensity maps of all fields were re-optimized and the plan dose was subsequently re-calculated. When final plan arrived, the dose statistics were calculated from both plans and compared. Results: For planned target volume (PTV), the dose for 95% volume is up to 10% higher in plans using the automated method than those using the manual method. For critical organs, an average decrease of the plan dose was achieved. However, the automated method cannot improve the plan dose for some critical organs due to limitations of the inference rules currently employed. For normal tissue, there was no significant difference between plan doses achieved by either automated or manual method. Conclusion: With the application of AI-guided method, the basic parameter adjustment task can be accomplished automatically and a comparable plan dose was achieved in comparison with that achieved by the manual

  7. Evaluation of an artificial intelligence guided inverse planning system: clinical case study.

    Science.gov (United States)

    Yan, Hui; Yin, Fang-Fang; Willett, Christopher

    2007-04-01

    An artificial intelligence (AI) guided method for parameter adjustment of inverse planning was implemented on a commercial inverse treatment planning system. For evaluation purpose, four typical clinical cases were tested and the results from both plans achieved by automated and manual methods were compared. The procedure of parameter adjustment mainly consists of three major loops. Each loop is in charge of modifying parameters of one category, which is carried out by a specially customized fuzzy inference system. A physician prescribed multiple constraints for a selected volume were adopted to account for the tradeoff between prescription dose to the PTV and dose-volume constraints for critical organs. The searching process for an optimal parameter combination began with the first constraint, and proceeds to the next until a plan with acceptable dose was achieved. The initial setup of the plan parameters was the same for each case and was adjusted independently by both manual and automated methods. After the parameters of one category were updated, the intensity maps of all fields were re-optimized and the plan dose was subsequently re-calculated. When final plan arrived, the dose statistics were calculated from both plans and compared. For planned target volume (PTV), the dose for 95% volume is up to 10% higher in plans using the automated method than those using the manual method. For critical organs, an average decrease of the plan dose was achieved. However, the automated method cannot improve the plan dose for some critical organs due to limitations of the inference rules currently employed. For normal tissue, there was no significant difference between plan doses achieved by either automated or manual method. With the application of AI-guided method, the basic parameter adjustment task can be accomplished automatically and a comparable plan dose was achieved in comparison with that achieved by the manual method. Future improvements to incorporate case

  8. Clinical evaluation of Kr-81m inhalation study through a dead space

    International Nuclear Information System (INIS)

    Kurosawa, Hiromi; Matsubayashi, Satsuki; Ishii, Yasuko; Ishida, Hirohide; Hirasawa, Yukinori; Mori, Yutaka; Shimada, Takao; Kawakami, Kenji

    1990-01-01

    A new inhalation technique of 81m Kr gas was applied to evaluate the pathophysiological abnormality of ventilation. 81m Kr gas (370 MBq) was continuously supplied into a mouth piece directly (without dead space), V E , or through a dead space of 500 ml, V L , in 110 subjects with various lung diseases. Subjects were divided in four groups by a combination of distribution patterns of 81m Kr gas obtained by these two inhalation techniques. Group 1: No ventilatory defect in both techniques. Group 2: Defects larger in V E than V L . Group 3: Defects larger in V L than V E . Group 4: no remarkable difference in defects in both techniques. Cases of group 1 were normal in pulmonary function test and chest X-ray. Finding of group 2 reflects early airway closure. This group consisted of cases in remission of bronchial asthma, small air way disease and pulmonary congestion. In group 3, restrictive disease and obstructive disease, especially emphysema, were included. Patients with severe obstructive disease and organized change of pulmonary parenchyma were belonged in group 4. In ventilation study with 81m Kr gas, a combined study of inhalation technique through a dead space and by direct infusion may be useful to evaluate a pathophysiological change of various pulmonary diseases. (author)

  9. Evaluation of Hanau's formula in determination of lateral condylar guidance: A clinical research study

    Science.gov (United States)

    Bhawsar, Sanjay Vasant; Marathe, Ashlesha Subhash; Ansari, Sadekh Abdul

    2015-01-01

    Statement of Problem: The accuracy and reliability of the methods used for programming the semi-adjustable articulators determine the accuracy in occlusion. The current recommended average settings using the Hanau's formula commonly used by clinicians is questionable, and thus reassessment is needed. This study was carried out to evaluate and compare the lateral condylar guidance: (1) Using the Hanau's formula and the computerized jaw tracking device (Kinesiograph). (2) On the right and left sides using both these methods. Materials and Methods: A total of 20 completely edentulous patients (14 male and 6 females) within 40–60 years of age were selected. Jaw relation was recorded followed by face bow transfer. Extraoral Gothic arch tracing was recorded; three protrusive records were obtained and condylar guidance was calculated. Lateral condylar guidance was then calculated using Hanau's formula, followed by the computerized jaw tracking device. A comparative evaluation was done of the obtained values. The same investigator worked with each of the study participants for the purpose of standardization. Results: The lateral condylar guidance values obtained using the Hanau's formula ranged from 14 to 17° while those obtained using the computerized K7 jaw tracking device ranged from 8 to 40°. Bennett angle values, obtained using the jaw tracking device and Hanau's formula showed statistically significant differences (P 0.05). Conclusion: Based on the results, dentist and dental technicians should consider reassessing the current recommended average settings and use of the Hanau's formula for programming the semi-adjustable articulators. PMID:26929535

  10. Angular stable plates in proximal meta-epiphyseal tibial fractures: study of joint restoration and clinical and functional evaluation.

    Science.gov (United States)

    Giannotti, S; Giovannelli, D; Dell'Osso, G; Bottai, V; Bugelli, G; Celli, F; Citarelli, C; Guido, G

    2016-04-01

    The tibial plateau fractures involve one of the main weight bearing joints of the human body. The goals of surgical treatment are anatomical reduction, articular surface reconstruction and high primary stability. The aim of this study was to evaluate the clinical and functional outcomes after internal plate fixation of this kind of fractures. From January 2009 to December 2012, we treated 75 cases of tibial plateau fracture with angular stable plates. We used Rasmussen Score and the Knee Society Score for the clinical and functional evaluation. Twenty-five cases that underwent hardware removal had arthroscopic and CT evaluation of the joint. No complications occurred. The clinical and functional evaluation, performed by the KSS and Rasmussen Score, highlighted the high percentage of good-to-excellent results (over 90 %). In every case, the range of motion was good with flexion >90°. Arthroscopy showed the presence of chondral damage in 100 % of patients. In all the cases, we found that X-ray images seem better than the CT images. Angular stable plates allow to obtain a good primary stability, permitting an early joint recovery with an excellent range of motion. Avoiding to perform a knee arthrotomy at the time of fracture reduction could prove to be an advantage in terms of functional recovery. The meniscus on the injured bone should be preserved in order to maintain good function of the joint. X-ray images remain the gold standard in checking the progression of post-traumatic osteoarthritis.

  11. Evaluation of dental plaque control in patients wearing fixed orthodontic appliances: a clinical study.

    Science.gov (United States)

    Ousehal, Lahcen; Lazrak, Laila; Es-Said, Rabia; Hamdoune, Hind; Elquars, Farid; Khadija, Amine

    2011-03-01

    Multibracket orthodontic appliances increase dental plaque retention and make teethbrushing more difficult for patients. As a result, advice from the orthodontist on oral hygiene along with patient motivation regarding teethbrushing are particularly important. The aim of this study was to compare the efficacy of electric toothbrushes with that of manual brushing associated with mouth-rinses comprising chlorhexidine (0.12%) and 0% alcohol. To this end, 84 patients receiving current orthodontic treatment were randomly selected from patients treated at the Dento-Facial Orthopedics department in the Casablanca Dental Consultation and Treatment Center. Selected patients were divided into three groups: Group 1: manual teethbrushing; Group 2: electric teethbrushing; Group 3: manual brushing combined with mouth rinse. Oral hygiene was assessed using the Loe-Silness plaque and gingival indices. Measurements were made before and 4 weeks after the observation period. Results were subjected to statistical comparison in order to determine the group showing greatest improvement and to deduce the best means of controlling bacterial plaque. The electric toothbrush and the chlorhexidine mouth rinse appear to control dental plaque more effectively than manual teethbrushing alone. Following this study, patients receiving multibracket treatment were invited to combine manual brushing with short clinical mouth-rinsing sessions or to use an electric toothbrush. Copyright © 2011 CEO. Published by Elsevier Masson SAS. All rights reserved.

  12. Prospective clinical study to evaluate an oscillometric blood pressure monitor in pet rabbits.

    Science.gov (United States)

    Bellini, Luca; Veladiano, Irene A; Schrank, Magdalena; Candaten, Matteo; Mollo, Antonio

    2018-02-27

    Rabbits are particularly sensitive to develop hypotension during sedation or anaesthesia. Values of systolic or mean non-invasive arterial blood pressure below 80 or 60 mmHg respectively are common under anaesthesia despite an ongoing surgery. A reliable method of monitoring arterial blood pressure is extremely important, although invasive technique is not always possible due to the anatomy and dimension of the artery. The aim of this study was to evaluate the agreement between a new oscillometric device for non-invasive arterial blood pressure measurement and the invasive method. Moreover the trending ability of the device, ability to identify changes in the same direction with the invasive methods, was evaluated as well as the sensibility of the device in identifying hypotension arbitrarily defined as invasive arterial blood pressure below 80 or 60 mmHg. Bland-Altman analysis for repeated measurements showed a poor agreement between the two methods; the oscillometric device overestimated the invasive arterial blood pressure, particularly at high arterial pressure values. The same analysis repeated considering oscillometric measurement that match invasive mean pressure lower or equal to 60 mmHg showed a decrease in biases and limits of agreement between methods. The trending ability of the device, evaluated with both the 4-quadrant plot and the polar plot was poor. Concordance rate of mean arterial blood pressure was higher than systolic and diastolic pressure although inferior to 90%. The sensibility of the device in detecting hypotension defined as systolic or mean invasive arterial blood pressure lower than 80 or 60 mmHg was superior for mean oscillometric pressure rather than systolic. A sensitivity of 92% was achieved with an oscillometric measurement for mean pressure below 65 mmHg instead of 60 mmHg. Non-invasive systolic blood pressure is less sensitive as indicator of hypotension regardless of the cutoff limit considered. Although mean invasive

  13. Clinical evaluation of removable partial dentures on the periodontal health of abutment teeth: a retrospective study.

    Science.gov (United States)

    Dula, Linda J; Ahmedi, Enis F; Lila-Krasniqi, Zana D; Shala, Kujtim Sh

    2015-01-01

    The aim of this retrospective study was to evaluate the effect of removable partial dentures in periodontal abutment teeth in relation to the type of denture support and design of RPD in a five-year worn period. Methods : A total of 64 patients with removable partial dentures (RPDs), participated in this study. It were examined ninety-one RPDs. There were seventy-five RPDs with clasp-retained and sixteenth were RPDs with attachments. There were 28 females and 36 males, aged between 40-64 years, 41 maxillary and 50 mandible RPDs. For each subjects the following data were collected: denture design, denture support, and Kennedy classification. Abutment teeth were assessed for plaque index (PI), calculus index (CI), blending on probing (BOP), probing depth (PD), gingival recession (GR), tooth mobility (TM). Level of significance was set at pdenture support of RPD, BOP, PD, PI, GR, CI and TM-index showed no statistically significant difference. Based on the denture design of RPD's, BOP, PD, PI, CI, and TM-index proved no statistically significant difference. Except GR-index according to denture design confirmed statistically significant difference in RPD with clasp pdentures and below the clasp arms in abutment teeth.

  14. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study

    Science.gov (United States)

    Delnoy, Peter Paul; Ritter, Philippe; Naegele, Herbert; Orazi, Serafino; Szwed, Hanna; Zupan, Igor; Goscinska-Bis, Kinga; Anselme, Frederic; Martino, Maria; Padeletti, Luigi

    2013-01-01

    Aims The long-term clinical value of the optimization of atrioventricular (AVD) and interventricular (VVD) delays in cardiac resynchronization therapy (CRT) remains controversial. We studied retrospectively the association between the frequency of AVD and VVD optimization and 1-year clinical outcomes in the 199 CRT patients who completed the Clinical Evaluation on Advanced Resynchronization study. Methods and results From the 199 patients assigned to CRT-pacemaker (CRT-P) (New York Heart Association, NYHA, class III/IV, left ventricular ejection fraction failure-related hospitalization, NYHA functional class, and Quality of Life score, at 1 year. Systematic CRT optimization was associated with a higher percentage of improved patients based on the composite endpoint (85% in Group 1 vs. 61% in Group 2, P < 0.001), with fewer deaths (3% in Group 1 vs. 14% in Group 2, P = 0.014) and fewer hospitalizations (8% in Group 1 vs. 23% in Group 2, P = 0.007), at 1 year. Conclusion These results further suggest that AVD and VVD frequent optimization (at implant, at 3 and 6 months) is associated with improved long-term clinical response in CRT-P patients. PMID:23493410

  15. Use of 3D MR reconstructions in the evaluation of glenoid bone loss: a clinical study

    International Nuclear Information System (INIS)

    Gyftopoulos, Soterios; Beltran, Luis S.; Yemin, Avner; Recht, Michael P.; Strauss, Eric; Meislin, Robert; Jazrawi, Laith

    2014-01-01

    To assess the ability of 3D MR shoulder reconstructions to accurately quantify glenoid bone loss in the clinical setting using findings at the time of arthroscopy as the gold standard. Retrospective review of patients with MR shoulder studies that included 3D MR reconstructions (3D MR) produced using an axial Dixon 3D-T1W-FLASH sequence at our institution was conducted with the following inclusion criteria: history of anterior shoulder dislocation, arthroscopy (OR) performed within 6 months of the MRI, and an estimate of glenoid bone loss made in the OR using the bare-spot method. Two musculoskeletal radiologists produced estimates of bone loss along the glenoid width, measured in mm and %, on 3D MR using the best-fit circle method, which were then compared to the OR measurements. There were a total of 15 patients (13 men, two women; mean age, 28, range, 19-51 years). There was no significant difference, on average, between the MRI (mean 3.4 mm/12.6 %; range, 0-30 %) and OR (mean, 12.7 %; range, 0-30 %) measurements of glenoid bone loss (p = 0.767). A 95 % confidence interval for the mean absolute error extended from 0.45-2.21 %, implying that, when averaged over all patients, the true mean absolute error of the MRI measurements relative to the OR measurements is expected to be less than 2.21 %. Inter-reader agreement between the two readers had an IC of 0.92 and CC of 0.90 in terms of percentage of bone loss. 3D MR reconstructions of the shoulder can be used to accurately measure glenoid bone loss. (orig.)

  16. Use of 3D MR reconstructions in the evaluation of glenoid bone loss: a clinical study

    Energy Technology Data Exchange (ETDEWEB)

    Gyftopoulos, Soterios; Beltran, Luis S.; Yemin, Avner; Recht, Michael P. [NYU Langone Medical Center, Department of Radiology, New York, NY (United States); Strauss, Eric; Meislin, Robert; Jazrawi, Laith [NYU Langone Medical Center, Center for Musculoskeletal Care, Department of Orthopaedic Surgery, New York, NY (United States)

    2014-02-15

    To assess the ability of 3D MR shoulder reconstructions to accurately quantify glenoid bone loss in the clinical setting using findings at the time of arthroscopy as the gold standard. Retrospective review of patients with MR shoulder studies that included 3D MR reconstructions (3D MR) produced using an axial Dixon 3D-T1W-FLASH sequence at our institution was conducted with the following inclusion criteria: history of anterior shoulder dislocation, arthroscopy (OR) performed within 6 months of the MRI, and an estimate of glenoid bone loss made in the OR using the bare-spot method. Two musculoskeletal radiologists produced estimates of bone loss along the glenoid width, measured in mm and %, on 3D MR using the best-fit circle method, which were then compared to the OR measurements. There were a total of 15 patients (13 men, two women; mean age, 28, range, 19-51 years). There was no significant difference, on average, between the MRI (mean 3.4 mm/12.6 %; range, 0-30 %) and OR (mean, 12.7 %; range, 0-30 %) measurements of glenoid bone loss (p = 0.767). A 95 % confidence interval for the mean absolute error extended from 0.45-2.21 %, implying that, when averaged over all patients, the true mean absolute error of the MRI measurements relative to the OR measurements is expected to be less than 2.21 %. Inter-reader agreement between the two readers had an IC of 0.92 and CC of 0.90 in terms of percentage of bone loss. 3D MR reconstructions of the shoulder can be used to accurately measure glenoid bone loss. (orig.)

  17. A cross-sectional, clinical study to evaluate mobility of teeth during pregnancy using periotest

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    Poonam Sujeet Mishra

    2017-01-01

    Full Text Available Background and Objective: Over a century, an increased prevalence of gingival diseases associated with increasing plasma sex steroid hormone levels has been reported. These situations present unique challenges to the oral health-care professional. It is believed that hormonal fluctuations such as those associated with pregnancy, menstruation, and use of hormonal contraceptives lead to an increase in tooth mobility. However, this effect of female sex hormones on periodontal ligament and tooth-supporting alveolar bone has rarely been investigated. Hence, this study was conducted to understand the effect of hormonal changes during pregnancy on tooth mobility. Materials and Methods: Mobility of index teeth 16, 13, 21, 23, 24, 36, 33, 41, 43, and 44 was measured with periotest for fifty pregnant females at first trimester (12th week, second trimester (24th week, and third trimester (35th week. Simplified oral hygiene index, plaque index, Gingival index (GI, and probing depth were also evaluated during the three trimesters of pregnancy for each subject participating in the study. Statistical Analysis: The results of the study were subjected to statistical analysis. Data analysis was done by applying Z-test for comparing difference between two sample means. Results: A small but statistically significant influence on the periotest value was seen during the three trimesters of pregnancy. GI scores significantly increased throughout pregnancy despite no significant change in plaque levels. Conclusion: Pregnancy had a significant influence on tooth mobility. Highest value of tooth mobility was seen in the last month of pregnancy. The maximum severity of gingivitis was also seen during the third trimester of pregnancy.

  18. Clinical Study Preoperative Evaluation with f MRI of Patients with Intracranial Gliomas Ioannis

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    Kapsalakis, Z.; Hadjigeorgiou, G.; Papadimitriou, A.; Kapsalaki, E.Z.; Fezoulidis, I.; Gotsis, E.D.; Verganelakis, D.; Toulas, P.; Chung, I.; Robinson, J.S.; Lee, J.P.; Fountas, K.N.; Fountas, K.N.

    2012-01-01

    Aggressive surgical resection constitutes the optimal treatment for intracranial gliomas. However, the proximity of a tumor to eloquent areas requires exact knowledge of its anatomic relationships to functional cortex. The purpose of our study was to evaluate f MRI’s accuracy by comparing it to intraoperative cortical stimulation (DCS) mapping. Material and Methods. Eighty-seven patients, with presumed glioma diagnosis, underwent preoperative fMRI and intraoperative DCS for cortical mapping during tumor resection. Findings of fMRI and DCS were considered concordant if the identified cortical centers were less than 5 mm apart. Pre and postoperative Karnofsky Performance Scale and Spitzer scores were recorded. A postoperative MRI was obtained for assessing the extent of resection. Results. The areas of interest were identified by f MRI and DCS in all participants. The concordance between f MRI and Dncs was 91.9% regarding sensory-motor cortex, 100% for visual cortex, and 85.4% for language. Data analysis showed that patients with better functional condition demonstrated higher concordance rates, while there also was a weak association between tumor grade and concordance rate. The mean extent of tumor resection was 96.7%. Conclusions. Functional MRI is a highly accurate preoperative methodology for sensory-motor mapping. However, in language mapping, DCS remains necessary for accurate localization

  19. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

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    Anita Panda

    2011-01-01

    Full Text Available Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV in post-penetrating-keratoplasty glaucoma (PKPG. Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7 implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5 < IOP < 21 mmHg and qualified success as 5 < IOP < 21 mmHg with medications or minor procedures. Results: The mean IOP decreased from 42.95 ± 10.24 to 17.69 ± 3.64 mmHg (P < 0.001 and the use of medications dropped from 2.92 to 0.39 (P < 0.001 after AGV implantation. The absolute success was achieved in 11 eyes and qualified success in 9. There was no significant change in best corrected visual acuity, graft clarity, or graft thickness. Six device-related complications occurred after AGV implantations which were successfully managed with medical or minor surgical therapy. Conclusions: Postkeratoplasty refractory glaucoma managed by AGV implantation revealed a satisfactory outcome up to 6 months of follow-up.

  20. Evaluation of magnocellular pathway abnormalities in schizophrenia: a frequency doubling technology study and clinical implications

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    Fabiana Benites Vaz de Lima

    2013-04-01

    Full Text Available BACKGROUND: Visual processing deficits have been reported for patients with schizophrenia. Previous studies demonstrated differences in early-stage processing of schizophrenics, although the nature, extent, and localization of the disturbance are unknown. The magnocellular and parvocellular visual pathways are associated with transient and sustained channels, but their respective contributions to schizophrenia-related visual deficits remains controversial. PURPOSE: The aim of this study was to evaluate magnocellular dysfunction in schizophrenia using frequency doubling technology. METHODS: Thirty-one patients with schizophrenia and 34 healthy volunteers were examined. Frequency doubling technology testing was performed in one session, consisting of a 15-minute screening strategy followed by the C-20 program for frequency doubling technology. RESULTS: Schizophrenic patients showed lower global mean sensitivity (30,97 ± 2,25 dB compared with controls (32,17 ± 3,08 dB, p<0.009. Although there was no difference in the delta sensitivity of hemispheres, there was a difference in sensitivity analysis of the fibers crossing the optic chiasm, with lower mean sensitivity in the patient group (28,80 dB versus controls (30,66 dB. The difference was higher in fibers that do not cross the optic chiasm, with lower mean sensitivity in patients (27,61 dB versus controls (30,26 dB, p<0.005. CONCLUSIONS: Our results suggest that there are differences between global sensitivity and fiber sensitivity measured by frequency doubling technology. The different sensitivity of fibers that do not cross the optic chiasm is consistent with most current etiological hypotheses for schizophrenia. The decreased sensitivity responses in the optic radiations may significantly contribute to research assessing early-stage visual processing deficits for patients with schizophrenia.

  1. Comparative evaluation of gingival depigmentation by tetrafluroethane cryosurgery and surgical scalpel technique. A randomized clinical study

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    Suraj D Narayankar

    2017-01-01

    Full Text Available Introduction: Importance of good smile cannot be underestimated in enhancement of beauty, self-confidence and personality of a person. Health and appearance of gingiva is an essential part of attractive smile. Gingival pigmentation gives rise to unesthetic smile line. In present world, with increasing awareness to esthetic, people have become highly concerned about black gums. Various treatment modalities like abrasion, scrapping, scalpel technique, cryosurgery, electrosurgery and laser are available for treatment of gingival pigmentation. The present study was conducted with an objective of comparing efficacy of gingival depigmentation by cryosurgery and scalpel technique. Method: A Randomized control split mouth study was conducted for 25 patients with gingival pigmentation. Gingival pigmentation Index (GPI for pigmentation and Visual Analoug Scale (VAS for pain was evaluated for both test (Cryosurgery and control sites (Scalpel technique at baseline, 1month, 3months and 6 months. Results: GPI score was 3 and 2 for 21/25 and 4/25 control sites and was 22/25 and 3/25 test sites respectively at baseline. Both the groups showed significant reduction in GPI score i.e., 0 at 1 and 3 months interval after treatment. GPI score increased to 1 for 5/25 sites treated with scalpel technique and 2/25 sites treated with cryosurgery at 6 months interval (P=0.0691. This indicates recurrence rate for pigmentation is higher after scalpel treatment. VAS Score was 3 for 10/25 sites treated with scalpel and was 2 for 12/25 sites treated with cryosurgery (P<0.001. Conclusion: It can be concluded that cryosurgery can be effectively and efficiently used for depigmentation by keeping patients acceptance and comfort in mind and also the long term results and ease of use when compared to scalpel technique.

  2. Evaluation of patient response and recurrence of pigmentation following gingival depigmentation using laser and scalpel technique: A clinical study

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    Harpreet Singh Grover

    2014-01-01

    Full Text Available Aim: The present study was undertaken to evaluate patient response and recurrence of pigmentation following gingival depigmentation carried out with a surgical blade and diode laser. Materials and Methods: Twenty patients who were esthetically conscious of their dark gums and requested treatment for the same were selected for this study. Complete phase I therapy was performed for all the patients before performing the gingival depigmentation procedures with laser and scalpel on a split-mouth basis. Patients were evaluated for pain (1 day, 1 week, wound healing and melanin repigmentation (Melanin Pigmentation Index immediately and at 1 week, 1 month and 3 months, respectively. Results: The final results were statistically analyzed and significance was evaluated. The results of this study indicated that both scalpel and laser were efficient for gingival depigmentation. Comparative pain assessment (P = 0.148 and repigmentation scores (P = 0.288 at various time intervals between the two groups did not show any statistical significance. Conclusion: Both the procedures did not result in any post-operative complications and the gingiva healed uneventfully. When compared, both the techniques were found to be equally efficacious. Care must be taken to assess the gingival biotype and the degree of pigmentation in deciding which technique is to be used. Clinical Significance: Various methods of depigmentation are available with comparable efficacies. Depigmentation is not a clinical indication but a treatment of choice where esthetics is a concern and is desired by the patient.

  3. Clinical and radiographic evaluation of zinc oxide with aloe vera as an obturating material in pulpectomy: An in vivo study

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    Abhishek Khairwa

    2014-01-01

    Full Text Available Background: Pulp therapy for pulpally involved primary teeth continues to be a challenge to clinicians. One of the major areas of continued research is in the area of finding obturating materials to suit the specific properties of these teeth. Zinc oxide eugenol is used frequently in pulpectomy for the obturation of the primary teeth. Aims: To evaluate clinically and radiographically a mixture of zinc oxide eugenol and aloe vera as an obturating material. Materials and Methods: A total of 50 children, aged between 4 and 9 years, who were screened for unilateral or bilateral carious deciduous molars were studied. Out of these, 15 children were randomly selected for endodontic treatment. Obturation was done with a mixture of zinc oxide powder and aloe vera gel. Clinical and radiographic evaluation was done after 7 days, 1 month, 3 months, 6 months, and 9 months. The data were statistically analyzed. Results and Conclusion: Endodontic treatment using a mixture of zinc oxide powder and aloe vera gel in primary teeth has shown good clinical and radiographic success. A detailed observational study with longer follow-up will highlight the benefits of aloe vera in primary teeth as an obturating medium.

  4. Evaluation of adjuvant chemoradiation therapy for ampullary adenocarcinoma: the Johns Hopkins Hospital - Mayo Clinic collaborative study

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    Narang, Amol K; Haddock, Michael G; Donohue, John H; Schulick, Richard D; Wolfgang, Christopher L; Cameron, John L; Herman, Joseph M; Miller, Robert C; Hsu, Charles C; Bhatia, Sumita; Pawlik, Timothy M; Laheru, Dan; Hruban, Ralph H; Zhou, Jessica; Winter, Jordan M

    2011-01-01

    The role of adjuvant chemoradiation therapy for ampullary carcinoma is unknown. Previous literature suggests that certain populations with high risk factors for recurrence may benefit from adjuvant chemoradiation. We combined the experience of two institutions to better delineate which patients may benefit from adjuvant chemoradiation. Patients who underwent curative surgery for ampullary carcinoma at the Johns Hopkins Hospital (n = 290; 1992-2007) and at the Mayo Clinic (n = 130; 1977-2005) were reviewed. Patients with <60 days of follow-up, metastatic disease at surgery, or insufficient pathologic data were excluded. The final combined study consisted of 186 patients (n = 104 Johns Hopkins, n = 82 Mayo). Most patients received 5-FU based chemoradiation with conformal radiation. Cox proportional hazards models were used for survival analysis. Median overall-survival was 39.9 months with 2- and 5-year survival rates of 62.4% and 39.1%. On univariate analysis, adverse prognostic factors for overall survival included T3/T4 stage disease (RR = 1.86, p = 0.002), node positive status (RR = 3.18, p < 0.001), and poor histological grade (RR = 1.69, p = 0.011). Patients who received adjuvant chemoradiation (n = 66) vs. surgery alone (n = 120) showed a higher rate of T3/T4 stage disease (57.6% vs. 30.8%, P < 0.001), lymph node involvement (72.7% vs. 30.0%, P < 0.001), and close or positive margins (4.6% vs. 0.0%, P = 0.019). Five year survival rates among node negative and node positive patients were 58.7% and 18.4% respectively. When compared with surgery alone, use of adjuvant chemoradiation improved survival among node positive patients (mOS 32.1 vs. 15.7 mos, 5 yr OS: 27.5% vs. 5.9%; RR = 0.47, P = 0.004). After adjusting for adverse prognostic factors on multivariate analysis, patients treated with adjuvant chemoradiation demonstrated a significant survival benefit (RR = 0.40, P < 0.001). Disease relapse occurred in 37.1% of all patients, most commonly metastatic

  5. Software-based evaluation of toric IOL orientation in a multicenter clinical study.

    Science.gov (United States)

    Kasthurirangan, Sanjeev; Feuchter, Lucas; Smith, Pamela; Nixon, Donald

    2014-12-01

    To evaluate the rotational stability of a new one-piece hydrophobic acrylic toric intraocular lens (IOL) using a custom-developed software for analysis of slit-lamp photographs. In a prospective, multicenter study, 174 eyes were implanted with the TECNIS Toric IOL (Abbott Medical Optics, Inc., Santa Ana, CA). A custom-developed software was used to analyze high-resolution slit-lamp photographs of 156 eyes taken at day 1 (baseline) and 1, 3, and 6 months postoperatively. The software uses iris and sclera landmarks to align the baseline image and later images for comparison. Validation of software was performed through repeated analyses of protractor images rotated from 0.1° to 10.0° and randomly selected photographs of 20 eyes. Software validation showed precision (repeatability plus reproducibility variation) of 0.02° using protractor images and 2.22° using slit-lamp photographs. Good quality slit-lamp images and clear landmarks were necessary for precise measurements. At 6 months, 94.2% of eyes had 5° or less change in IOL orientation versus baseline; only 2 eyes (1.4%) had axis shift greater than 30°. Most eyes were within 5° or less of rotation between 1 and 3 months (92.9%) and 3 and 6 months (94.1%). Mean absolute axis change (± standard deviation) from 1 day to 6 months was 2.70° ± 5.51°. The new custom software was precise and quick in analyzing slit-lamp photographs to determine postoperative toric IOL rotation. Copyright 2014, SLACK Incorporated.

  6. Evaluation of concordance between CAD/CAM and clinical positions of abutment shoulder against mucosal margin: an observational study.

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    Pietruski, Jan K; Skurska, Anna; Bernaczyk, Anna; Milewski, Robert; Pietruska, Maria Julia; Gehrke, Peter; Pietruska, Małgorzata D

    2018-05-02

    While working on CAD/CAM-customized abutments, the use of standard impression copings with a circular diameter produces inconsistency within the emergence profile. It may begin with a collapse of the supra-implant mucosa during impression taking, then lead to a computer-generated mismatch of the position and outline of the abutment shoulder, and consequently result in a compromised outcome of anticipated treatment. The aim of the study was to compare the virtual and clinical positions of the abutment shoulder in relation to the mucosal margin after the abutment delivery. Conventional open-tray impression takings followed uncovering surgery. Master casts were scanned with a desktop scanner. Clinical examinations took place after abutment's insertion and temporization (T1) and prior to cementation of the definitive crown (T2). The distances between the abutment shoulder and marginal soft tissue were measured intraorally in four aspects and juxtaposed with those on the virtual model. The study evaluated 257 dental implants and CAD/CAM-customized abutments. As T1 and T2 showed, there was a positive correlation between the virtually designed abutment shoulder position and matching clinical location relative to the mucosal margin. In 42.1% of cases, the distance between the mucosal margin and the abutment shoulder did not change. It increased in 36.3% of cases while a decrease occurred in 21.6% of them. Computer-set position of the abutment shoulder in relation to the mucosal margin can be predictably implemented in clinical practice.

  7. A prospective, longitudinal study to evaluate the clinical utility of a predictive algorithm that detects risk of opioid use disorder

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    Brenton, Ashley; Lee, Chee; Lewis, Katrina; Sharma, Maneesh; Kantorovich, Svetlana; Smith, Gregory A; Meshkin, Brian

    2018-01-01

    Purpose The purpose of this study was to determine the clinical utility of an algorithm-based decision tool designed to assess risk associated with opioid use. Specifically, we sought to assess how physicians were using the profile in patient care and how its use affected patient outcomes. Patients and methods A prospective, longitudinal study was conducted to assess the utility of precision medicine testing in 5,397 patients across 100 clinics in the USA. Using a patent-protected, validated algorithm combining specific genetic risk factors with phenotypic traits, patients were categorized into low-, moderate-, and high-risk patients for opioid abuse. Physicians who ordered precision medicine testing were asked to complete patient evaluations and document their actions, decisions, and perceptions regarding the utility of the precision medicine tests. The patient outcomes associated with each treatment action were carefully documented. Results Physicians used the profile to guide treatment decisions for over half of the patients. Of those, guided treatment decisions for 24.5% of the patients were opioid related, including changing the opioid prescribed, starting an opioid, or titrating a patient off the opioid. Treatment guidance was strongly influenced by profile-predicted opioid use disorder (OUD) risk. Most importantly, patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, including better pain management by medication adjustments, with an average pain decrease of 3.4 points on a scale of 1–10. Conclusion Patients whose physicians used the profile to guide opioid-related treatment decisions had improved clinical outcomes, as measured by decreased pain levels resulting from better pain management with prescribed medications. The clinical utility of the profile is twofold. It provides clinically actionable recommendations that can be used to 1) prevent OUD through limiting initial opioid

  8. Clinical and immunological evaluation of anti-apoptosis protein, survivin-derived peptide vaccine in phase I clinical study for patients with advanced or recurrent breast cancer

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    Asanuma Hiroko

    2008-05-01

    Full Text Available Abstract Background We previously reported that survivin-2B, a splicing variant of survivin, was expressed in various types of tumors and that survivin-2B peptide might serve as a potent immunogenic cancer vaccine. The objective of this study was to examine the toxicity of and to clinically and immunologically evaluate survivin-2B peptide in a phase I clinical study for patients with advanced or recurrent breast cancer. Methods We set up two protocols. In the first protocol, 10 patients were vaccinated with escalating doses (0.1–1.0 mg of survivin-2B peptide alone 4 times every 2 weeks. In the second protocol, 4 patients were vaccinated with the peptide at a dose of 1.0 mg mixed with IFA 4 times every 2 weeks. Results In the first protocol, no adverse events were observed during or after vaccination. In the second protocol, two patients had induration at the injection site. One patient had general malaise (grade 1, and another had general malaise (grade 1 and fever (grade 1. Peptide vaccination was well tolerated in all patients. In the first protocol, tumor marker levels increased in 8 patients, slightly decreased in 1 patient and were within the normal range during this clinical trial in 1 patient. With regard to tumor size, two patients were considered to have stable disease (SD. Immunologically, in 3 of the 10 patients (30%, an increase of the peptide-specific CTL frequency was detected. In the second protocol, an increase of the peptide-specific CTL frequency was detected in all 4 patients (100%, although there were no significant beneficial clinical responses. ELISPOT assay showed peptide-specific IFN-γ responses in 2 patients in whom the peptide-specific CTL frequency in tetramer staining also was increased in both protocols. Conclusion This phase I clinical study revealed that survivin-2B peptide vaccination was well tolerated. The vaccination with survivin-2B peptide mixed with IFA increased the frequency of peptide-specific CTL more

  9. [Clinical evaluation of flomoxef in pediatrics and a study on the penetration into cerebrospinal fluid].

    Science.gov (United States)

    Okada, T; Furukawa, S

    1987-08-01

    The transfer to cerebrospinal fluid of a new oxacephem antibiotic flomoxef (FMOX, 6315-S) and its clinical efficacy against bacterial infections were investigated. 1. In 3 cases of purulent meningitis, cerebrospinal fluid concentrations of FMOX after one shot intravenous injection of 100 mg/kg during the acute stage of infections were 5.12-6.32 micrograms/ml and ratios of FMOX in cerebrospinal fluid in serum were about 5%. During the recovery stage, cerebrospinal fluid concentrations were about 3.8 micrograms/ml and cerebrospinal fluid/serum ratios were about 3.5%. 2. In 1 case of purulent meningitis, the treatment with FMOX was clinically effective but this case was classified as "unevaluable" because other drug was used concomitantly. FMOX was rated effective in other 2 cases of purulent meningitis. Of 9 cases of pneumonia, FMOX was rated very effective in 8 cases and it was rated only effective in the other. Of 4 cases of bronchitis, the drug was rated very effective in 3 cases and only effective in the other. FMOX was rated very effective against 2 cases of tonsillitis, also. 3. As side effects, thrombocytosis was observed in 3 of 20 cases examined. All cases, however, were deemed unrelated to the FMOX treatment and the side effect was only transient as are often found in courses of recovery from infections.

  10. Generation and evaluation of 3D digital casts of maxillary defects based on multisource data registration: A pilot clinical study.

    Science.gov (United States)

    Ye, Hongqiang; Ma, Qijun; Hou, Yuezhong; Li, Man; Zhou, Yongsheng

    2017-12-01

    Digital techniques are not clinically applied for 1-piece maxillary prostheses containing an obturator and removable partial denture retained by the remaining teeth because of the difficulty in obtaining sufficiently accurate 3-dimensional (3D) images. The purpose of this pilot clinical study was to generate 3D digital casts of maxillary defects, including the defective region and the maxillary dentition, based on multisource data registration and to evaluate their effectiveness. Twelve participants with maxillary defects were selected. The maxillofacial region was scanned with spiral computer tomography (CT), and the maxillary arch and palate were scanned using an intraoral optical scanner. The 3D images from the CT and intraoral scanner were registered and merged to form a 3D digital cast of the maxillary defect containing the anatomic structures needed for the maxillary prosthesis. This included the defect cavity, maxillary dentition, and palate. Traditional silicone impressions were also made, and stone casts were poured. The accuracy of the digital cast in comparison with that of the stone cast was evaluated by measuring the distance between 4 anatomic landmarks. Differences and consistencies were assessed using paired Student t tests and the intraclass correlation coefficient (ICC). In 3 participants, physical resin casts were produced by rapid prototyping from digital casts. Based on the resin casts, maxillary prostheses were fabricated by using conventional methods and then evaluated in the participants to assess the clinical applicability of the digital casts. Digital casts of the maxillary defects were generated and contained all the anatomic details needed for the maxillary prosthesis. Comparing the digital and stone casts, a paired Student t test indicated that differences in the linear distances between landmarks were not statistically significant (P>.05). High ICC values (0.977 to 0.998) for the interlandmark distances further indicated the high

  11. Clinical evaluation of renal function study using I-123 orthoiodohippurate (I-123 OIH) in patients with obstructive uropathy

    International Nuclear Information System (INIS)

    Okada, Junichi; Uchiyama, Guio; Katsurai, Hiroshi; Uno, Koichi; Uematsu, Sadao.

    1984-01-01

    Functional images and regional renograms using I-123 OIH were evaluated by comparing with patients' clinical courses, intravenous pyelographies and Creatinine clearances. Twenty-one patients with obstructive uropathy were studied. Functional images were processed in three parameters of Tmax, T 1/2 and ERBF (effective renal blood flow). ERBF images were composed of regional counts in early blood flow phase of renograms. Regional renograms were produced on renal parenchyma and pelvis. ERBF images represented the functioning distributions of renal tissue after the surgery and the recoveries in the renal parenchyma. Tmax and T 1/2 images and pelvic regional renograms showed the good correlations with IVP findings which presented the dilatation of pelvis and the delay of excretion. Parenchymal regional renograms showed the poor correlations with Creatinine clearances and caused sometimes errors in ROI settings. The evaluation of renal function only by the parenchymal regional renogram seemed to be inappropriated. (author)

  12. Color changes of esthetic orthodontic ligatures evaluated by orthodontists and patients: a clinical study

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    Edilene Kawabata

    Full Text Available ABSTRACT Objective: To evaluate in vivo changes in the color of esthetic elastomeric ligatures from different manufacturers. Methods: Four widely used commercial brands of elastomeric ligatures were selected and used in 20 adult patients in a split-mouth design. The ligatures were evaluated by orthodontists and patients in a double-blind manner on the day the ligatures were placed (T0 and 30 days after intraoral exposure (T1 by means of a system of staining scores. Groups were compared by Friedman test with p 0.05. Results showed that all brands underwent significant staining when exposed to the intraoral environment. Modular-crystal MorelliTM (Sorocaba, SP, Brazil showed the highest degree of staining with the median reaching the maximum value (3; while the other brands (3M UnitekTM, American OrthodonticsTM and GAC DentsplyTM showed the median equal to 1 (p < 0.001. A large individual variability in the degree of staining was also found for all brands. Conclusions: All four brands of esthetic ligatures showed significant staining, which appeared to be more pronounced for the MorelliTM brand. Changes in color of the elastomeric ligatures were perceived similarly by patients and orthodontists. The industry needs to improve the color stability of esthetic ligatures.

  13. Development, implementation, and evaluation of a mental rehearsal strategy to improve clinical performance and reduce stress: A mixed methods study.

    Science.gov (United States)

    Ignacio, Jeanette; Dolmans, Diana; Scherpbier, Albert; Rethans, Jan-Joost; Lopez, Violeta; Liaw, Sok Ying

    2016-02-01

    Mental rehearsal is a form of mental training that has been used by physicians and nurses to improve performance of clinical skills, and as a vital component of stress management training. To help novice nurses deal with often stressful clinical events that require the processing of information essential to patient management, a mental rehearsal strategy was developed and implemented in a Year 3 nursing simulation program. Inherent to mental rehearsal is imagery, which facilitates cognitive and affective modification, and reduction of extraneous cognitive load. As such, it was expected that the mental rehearsal strategy would improve students' performance and reduce stress in managing deteriorating patients. The study used a mixed methods design. Eighteen Year 3 nursing students participated in the pre- and post-design study, which consisted of the development and implementation of a mental rehearsal strategy. The Rescuing A Patient In Deteriorating Situations (RAPIDS) tool was used to assess performance. Heart rates and systolic blood pressures were used to measure stress. The State-Trait Anxiety Inventory (STAI) was used as a psychological measure of stress/anxiety. Five participants were involved in a focus group discussion that evaluated the usefulness of the mental rehearsal strategy. There was a significant improvement in performance (Pstrategy. The mental rehearsal strategy for deteriorating patient management can be valuable based on the findings on performance and based on the participants' feedback. Its role in reducing stress, however, needs further evaluation. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. A clinical evaluation of the RNCA study using Fourier filtering as a preprocessing method

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    Robeson, W.; Alcan, K.E.; Graham, M.C.; Palestro, C.; Oliver, F.H.; Benua, R.S.

    1984-06-01

    Forty-one patients (25 male, 16 female) were studied by Radionuclide Cardangiography (RNCA) in our institution. There were 42 rest studies and 24 stress studies (66 studies total). Sixteen patients were normal, 15 had ASHD, seven had a cardiomyopathy, and three had left-sided valvular regurgitation. Each study was preprocessed using both the standard nine-point smoothing method and Fourier filtering. Amplitude and phase images were also generated. Both preprocessing methods were compared with respect to image quality, border definition, reliability and reproducibility of the LVEF, and cine wall motion interpretation. Image quality and border definition were judged superior by the consensus of two independent observers in 65 of 66 studies (98%) using Fourier filtered data. The LVEF differed between the two processes by greater than .05 in 17 of 66 studies (26%) including five studies in which the LVEF could not be determined using nine-point smoothed data. LV wall motion was normal by both techniques in all control patients by cine analysis. However, cine wall motion analysis using Fourier filtered data demonstrated additional abnormalities in 17 of 25 studies (68%) in the ASHD group, including three uninterpretable studies using nine-point smoothed data. In the cardiomyopathy/valvular heart disease group, ten of 18 studies (56%) had additional wall motion abnormalities using Fourier filtered data (including four uninterpretable studies using nine-point smoothed data). We conclude that Fourier filtering is superior to the nine-point smooth preprocessing method now in general use in terms of image quality, border definition, generation of an LVEF, and cine wall motion analysis. The advent of the array processor makes routine preprocessing by Fourier filtering a feasible technologic advance in the development of the RNCA study.

  15. A clinical evaluation of the RNCA study using Fourier filtering as a preprocessing method

    International Nuclear Information System (INIS)

    Robeson, W.; Alcan, K.E.; Graham, M.C.; Palestro, C.; Oliver, F.H.; Benua, R.S.

    1984-01-01

    Forty-one patients (25 male, 16 female) were studied by Radionuclide Cardangiography (RNCA) in our institution. There were 42 rest studies and 24 stress studies (66 studies total). Sixteen patients were normal, 15 had ASHD, seven had a cardiomyopathy, and three had left-sided valvular regurgitation. Each study was preprocessed using both the standard nine-point smoothing method and Fourier filtering. Amplitude and phase images were also generated. Both preprocessing methods were compared with respect to image quality, border definition, reliability and reproducibility of the LVEF, and cine wall motion interpretation. Image quality and border definition were judged superior by the consensus of two independent observers in 65 of 66 studies (98%) using Fourier filtered data. The LVEF differed between the two processes by greater than .05 in 17 of 66 studies (26%) including five studies in which the LVEF could not be determined using nine-point smoothed data. LV wall motion was normal by both techniques in all control patients by cine analysis. However, cine wall motion analysis using Fourier filtered data demonstrated additional abnormalities in 17 of 25 studies (68%) in the ASHD group, including three uninterpretable studies using nine-point smoothed data. In the cardiomyopathy/valvular heart disease group, ten of 18 studies (56%) had additional wall motion abnormalities using Fourier filtered data (including four uninterpretable studies using nine-point smoothed data). We conclude that Fourier filtering is superior to the nine-point smooth preprocessing method now in general use in terms of image quality, border definition, generation of an LVEF, and cine wall motion analysis. The advent of the array processor makes routine preprocessing by Fourier filtering a feasible technologic advance in the development of the RNCA study

  16. Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study.

    Science.gov (United States)

    Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily

    2013-04-08

    The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact

  17. Computer-aided design evaluation of harvestable mandibular bone volume: a clinical and tomographic human study.

    Science.gov (United States)

    Verdugo, Fernando; Simonian, Krikor; Raffaelli, Luca; D'Addona, Antonio

    2014-06-01

    To evaluate and compare the volume of bone graft material that can be safely harvested from the mandibular symphysis and rami using a computer-aided design (CAD) software program. Preoperative computerized tomography scans from 40 patients undergoing bone augmentation procedures were analyzed. Symphysis and rami cross sections were mapped using a CAD software program (AutoCAD(®), Autodesk, Inc., San Rafael, CA, USA) to evaluate the bone volume that can be safely harvested. CAD calculations were contrasted to intrasurgical measurements in a subgroup of 20 individuals. CAD calculations yielded a safe harvestable osseous volume of 1.44 cm(3) ± 0.49 for the symphysis and 0.82 cm(3) ± 0.21 for each ramus (p < .0001, confidence interval [CI] 95%: 0.47-0.78). These measurements were significantly lower (p < .0001) than the bone volumes harvested intrasurgically for both symphysis and ramus, respectively (2.40 cm(3) ± 0.50 vs. 2.65 cm(3) ± 0.45). CAD calculations of harvestable symphysis and ramus bone translated into an average of 2.40 cm(3) ± 0.50 (range: 1.80-3.10 cm(3)) and 2.65 cm(3) ± 0.45 (range: 1.90-3.50) of particulate bone graft intrasurgically, respectively. Ramus cortical was significantly thicker than the symphysis cortical, 2.9 ± 0.4 mm versus 2.19 mm ± 0.4 mm (p < .0001, CI 95%: 0.45-1.03). The symphysis and rami are good harvesting sources to obtain dense corticocancellous bone. The significant volumetric CAD differences between the symphysis and ramus seem to balance out intrasurgically and may be due to the greater cortical bone volume at the ramus area. It is plausible to harvest an average of 7.70 cm(3) from the symphysis and rami alone. The use of a CAD software program can enhance surgical treatment planning prior to bone transplantation. © 2012 Wiley Periodicals, Inc.

  18. Evaluating Study Withdrawal Among Biologics and Immunomodulators in Treating Ulcerative Colitis: A Meta-analysis of Controlled Clinical Trials.

    Science.gov (United States)

    Shah, Eric D; Siegel, Corey A; Chong, Kelly; Melmed, Gil Y

    2016-04-01

    We conducted a systematic review and meta-analysis to evaluate the efficacy and adverse event (AE)-associated tolerability of treatment with immunomodulators and biologics in ulcerative colitis clinical trials. We performed a literature search of PubMed and the Cochrane databases to identify randomized placebo-controlled trials of immunomodulators and biologics. Tolerability was defined through study withdrawal due to AEs and efficacy through clinical response in induction trials and clinical remission in maintenance trials. We performed meta-analyses using a random-effects model to determine relative risks (RRs) of efficacy and study withdrawal. Number needed to treat (NNT) and number needed to stop (NNS) were determined. The ratio of NNS/NNT was calculated, with a higher ratio indicating a greater number of patients in remission for every AE study discontinuation. We examined 13 single-agent trials representing biologics (infliximab, adalimumab, golimumab, and vedolizumab) and immunomodulators (tacrolimus and azathioprine). Induction therapy did not result in excess study withdrawal with immunomodulators (RR = 0.9, 95% CI 0.1-12.0) or biologics (RR = 0.7, 95% CI 0.3-1.8), therefore the NNS/NNT ratio could not be assessed because of high tolerability. Maintenance immunomodulator therapy resulted in a NNS of 14 (RR = 2.8, 95% CI 0.7-10.5) and NNS/NNT ratio of 2.4 in 2 trials. Biologics did not result in excess study withdrawal in maintenance (RR = 0.7, 95% CI 0.3-1.7) or combined induction-and-maintenance (RR = 0.6, 95% CI 0.4-1.0) trials. Biologics were not associated with a higher RR of study withdrawal due to AE than placebo. There were insufficient data to compare these results with immunomodulators.

  19. Evaluation of a classical unani pharmacopeial formulation safoof-e-muhazzil in hyperlipidemia: A randomized, standard controlled clinical study

    Directory of Open Access Journals (Sweden)

    Umar Jahangir

    2014-01-01

    Full Text Available Aim of the Study: The aim of the following study is to evaluate the efficacy and tolerability of a compound Unani formulation in hyperlipidemia on clinical and biochemical parameters. Materials and Methods: A total of 90 patients with total cholesterol level of 220 mg/dl and above were included. In Group ′A′ thirty patients with total cholesterol 243.5 ± 5.294 mg/dl received Unani formulation safoof-e-muhazzil (SM in its classical powder form 5 g twice daily orally, in Group ′B′ thirty patients with total cholesterol 234 ± 3.822 mg/dl received the SM but in compressed tablet form in the same dosage and in Group ′C′ 30 patients with total cholesterol 242.7 ± 5.563 mg/dl received atorvastatin 10 mg as a standard control. Follow-up was carried out on second, fourth and 6th week and patients were evaluated on clinical as well as biochemical parameters. Results: Group A before treatment had mean total cholesterol of 243.5 ± 5.294 mg/dl which decreased significantly after treatment to 225.6 ± 5.953 mg/dl (P 0.5 relief in palpitation and 26.17% (P < 0.001 relief in dyspnea post-treatment. Group B fatigue decreased significantly by 18.14% (P < 0.01, palpitation by 22.91% (P < 0.01 and dyspnea by 20.46% (P < 0.01. In Group C a non-significant increase of 2.2% was observed in fatigue post-treatment, palpitation decreased by 10.22% non-significantly and dyspnea decreased significantly by 17.64% (P < 0.001. Results indicate that the test drug safely and effectively ameliorates the clinical condition of patients with hyperlipidemia while decreasing cholesterol level as well.

  20. Evaluation of efficacy of aloe vera in the treatment of oral submucous fibrosis - a clinical study.

    Science.gov (United States)

    Anuradha, Ardra; Patil, Bharati; Asha, Venkataswamy Reddy

    2017-01-01

    Oral submucous fibrosis is a chronic disease, treatment of which has largely been symptomatic. Aloe vera has immunomodulatory, anti-inflammatory, wound healing, antioxidant, and antineoplastic activities. All such properties of aloe vera suggest the possibility of its use in the management of oral submucous fibrosis. Seventy-four patients of oral submucous fibrosis were randomly divided into 2 groups. Group A patients were treated with systemic (juice) and topical aloe vera (gel) for 3 months. Group B patients were treated with intralesional injection of hydrocortisone and hyaluronidase for 6 weeks with antioxidant supplements for 3 months. Patients were assessed for reduction in burning sensation and increase in mouth opening, cheek flexibility, and tongue protrusion at an interval of 1, 2, and 3 months. Both the groups showed statistically significant improvements in all the study parameters at the end of study period (P aloe vera was comparable to that of intralesional injections of hydrocortisone and hyaluronidase with antioxidant supplementation. The study concludes that aloe vera can be an alternative, safe, and effective treatment regime in the management of oral submucous fibrosis. Long-term follow-up studies with larger sample size are recommended. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  1. Study of clinical parameters and laboratory evaluation of metabolic syndrome in adolescents

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    Ayesha Imran

    2015-01-01

    Full Text Available Introduction: Worldwide incidence of obesity is rising. Genetic predisposition, urbanization, sedentary lifestyle, television watching, food habits, and lack of exercise are contributing factors. They result in obesity-related morbidity like metabolic syndrome, stroke in young, coronary artery disease, and diabetes. Materials and Methods: A cross-sectional study was undertaken among 1000 adolescents of both genders, aged 12-19 years in three schools of Pimpri, Pune, after obtaining approval from Institutional Ethical Committee. The criterion used to diagnose metabolic syndrome was International Diabetes Federation definition. The Chi-square test was used to explore the association between metabolic syndrome and various predictors. A P value of 0.05 was accepted as the level of statistical significance. Results: In the study sample, the prevalence of metabolic syndrome was 16/1000. Females were more likely to have metabolic syndrome (male:female = 7:9. Factors associated were body mass index (BMI, waist-hip ratio (WHR, birth weight, skin fold thickness, body fat percentage, faulty dietary habits, and sedentary lifestyles (P < 0.05. Among all, the components of metabolic syndrome, raised triglyceride (75%, and fasting blood sugar level (75% were more prevalent than high-density lipoprotein-cholesterol (44% and hypertension (37.5%. Conclusion: Metabolic syndrome was found to be more prevalent in females of age group 16-19 years, among the obese population, associated with birth weight, BMI, and WHR.

  2. Evaluation of three topical anaesthetic agents against pain : A clinical study

    Directory of Open Access Journals (Sweden)

    Nayak R

    2006-01-01

    Full Text Available AIM : To compare pain responses of children during local anaesthetic infiltration at bilateral buccal sites prepared with topical application of EMLA 5% cream, benzocaine 18% gel or lignocaine 5% ointment and also to find out the rapidity of onset of action of these agents. METHODS : 60 healthy children aged 6 to 12 years old, received bilateral buccal infiltration following application of topical anaesthetic agents applied in a double blind design. Pain responses were compared based on subject self report using visual analogue scale (VAS and operator assessment using Sound -Eye -Motor (SEM scale. RESULTS : Benzocaine gel had the rapidest onset of action. EMLA 5% cream proved to be superior in pain reduction compared to benzocaine and lignocaine. Taste acceptance was better with benzocaine gel. Further studies are required for EMLA cream with an improved formulation more suitable for mucosal application before its routine use in dentistry.

  3. Electrophysiological evaluation of phrenic nerve injury during cardiac surgery – a prospective, controlled, clinical study

    Directory of Open Access Journals (Sweden)

    Ege Turan

    2004-01-01

    Full Text Available Abstract Background According to some reports, left hemidiaphragmatic paralysis due to phrenic nerve injury may occur following cardiac surgery. The purpose of this study was to document the effects on phrenic nerve injury of whole body hypothermia, use of ice-slush around the heart and mammary artery harvesting. Methods Electrophysiology of phrenic nerves was studied bilaterally in 78 subjects before and three weeks after cardiac or peripheral vascular surgery. In 49 patients, coronary artery bypass grafting (CABG and heart valve replacement with moderate hypothermic (mean 28°C cardiopulmonary bypass (CPB were performed. In the other 29, CABG with beating heart was performed, or, in several cases, peripheral vascular surgery with normothermia. Results In all patients, measurements of bilateral phrenic nerve function were within normal limits before surgery. Three weeks after surgery, left phrenic nerve function was absent in five patients in the CPB and hypothermia group (3 in CABG and 2 in valve replacement. No phrenic nerve dysfunction was observed after surgery in the CABG with beating heart (no CPB or the peripheral vascular groups. Except in the five patients with left phrenic nerve paralysis, mean phrenic nerve conduction latency time (ms and amplitude (mV did not differ statistically before and after surgery in either group (p > 0.05. Conclusions Our results indicate that CPB with hypothermia and local ice-slush application around the heart play a role in phrenic nerve injury following cardiac surgery. Furthermore, phrenic nerve injury during cardiac surgery occurred in 10.2 % of our patients (CABG with CPB plus valve surgery.

  4. A Phase III clinical study to evaluate the efficacy of combined azithromycin and dexamethasone in the treatment of blepharoconjunctivitis

    Directory of Open Access Journals (Sweden)

    Hosseini K

    2013-11-01

    Full Text Available Kamran Hosseini,1,2 Judith Hutcheson,1 Richard L Lindstrom3–5 1Clinical Affairs, 2Regulatory Affairs, InSite Vision Incorporated, Alameda, CA, USA; 3Minnesota Eye Consultants, Bloomington, MN, USA; 4University of Minnesota Department of Ophthalmology, Minneapolis, MN, USA; 5University of California, Irvine Gavin Herbert Eye Institute, Irvine, CA, USA Purpose: The purpose of this study was to evaluate the clinical and antimicrobial efficacy and safety of ISV-502 (1.0% azithromycin and 0.1% dexamethasone compared to 1.0% azithromycin or 0.1% dexamethasone in the treatment of subjects with blepharoconjunctivitis. Patients and methods: Patients with verified blepharoconjunctivitis were randomized to receive ISV-502 (Group 1; n=140, 1.0% azithromycin alone (Group 2; n=141, or 0.1% dexamethasone alone (Group 3; n=136. Bacterial cultures were obtained from the conjunctiva and eyelid. Treatment was instilled in both eyes twice daily at 12-hour intervals for 14 days. The primary endpoint was complete resolution of clinical signs and symptoms at Day 15. The secondary endpoint was complete bacterial eradication at Day 15 among subjects with positive bacterial cultures at baseline. Results: Significantly more Group 1 subjects met the primary endpoint (27.1% than those in Group 2 (15.6%; P=0.028, but not compared to Group 3 (23.5%; P=0.581. Significantly more Group 1 patients (60% had complete bacterial eradication at Day 15 compared with Group 3 (40.2%; P=0.007, but there was no difference compared with Group 2 (66.3%; P=0.306. Adverse events were reported in about 25% of the subjects, with an equal distribution among treatment arms; the most common adverse event was irritation at the instillation site. Visual acuity and intraocular pressure differences were not statistically significant, but did show age and sex differences between groups. Conclusion: ISV-502 is effective in the treatment of blepharoconjunctivitis as evaluated by clinical cure and

  5. Clinical and Radiographic Evaluation of Procedural Errors during Preparation of Curved Root Canals with Hand and Rotary Instruments: A Randomized Clinical Study

    Science.gov (United States)

    Khanna, Rajesh; Handa, Aashish; Virk, Rupam Kaur; Ghai, Deepika; Handa, Rajni Sharma; Goel, Asim

    2017-01-01

    Background: The process of cleaning and shaping the canal is not an easy goal to obtain, as canal curvature played a significant role during the instrumentation of the curved canals. Aim: The present in vivo study was conducted to evaluate procedural errors during the preparation of curved root canals using hand Nitiflex and rotary K3XF instruments. Materials and Methods: Procedural errors such as ledge formation, instrument separation, and perforation (apical, furcal, strip) were determined in sixty patients, divided into two groups. In Group I, thirty teeth in thirty patients were prepared using hand Nitiflex system, and in Group II, thirty teeth in thirty patients were prepared using K3XF rotary system. The evaluation was done clinically as well as radiographically. The results recorded from both groups were compiled and put to statistical analysis. Statistical Analysis: Chi-square test was used to compare the procedural errors (instrument separation, ledge formation, and perforation). Results: In the present study, both hand Nitiflex and rotary K3XF showed ledge formation and instrument separation. Although ledge formation and instrument separation by rotary K3XF file system was less as compared to hand Nitiflex. No perforation was seen in both the instrument groups. Conclusion: Canal curvature played a significant role during the instrumentation of the curved canals. Procedural errors such as ledge formation and instrument separation by rotary K3XF file system were less as compared to hand Nitiflex. PMID:29042727

  6. Basic and clinical evaluation of our newly developed radiographic orthopantomography in studying the TMJ

    Energy Technology Data Exchange (ETDEWEB)

    Takagi, Sumio

    1987-03-01

    Temporomandibular arthrosis has been reported in many fields: oral surgery, dental prosthetics, otolaryngology, radiology, psychosomatic medicine etc... Roentgenographic examination plays an important role in the diagnosis of temporomandibular arthrosis. There have been studies on various types of roentgenography of the temporomandibular joint, but because its anatomical morphology is so complicated that it is difficult to obtain an adequate roentgenograph. Thus, no definite method of roentgenography has been clearly established. We developed a new method of roentgenography that takes advantage of the characteristics of orthopantomography, and analyzed our results statistically. The following results were obtained: 1) As conditions for roentgenography, the optimal tube voltage was 60 -- 75 KVp, but this varied according to sex and age; the optimal tube current was 15 mA. 2) The optimal position of the head in the anteroposterior position was 10 mm in front of the standard point, and that in the vertical position was the central part of the film. 3) The optimal position of the head was reached when the OM line was horizontal. 4) On the basis of the data obtained from these basic experiments, images from standard roentgenography were compared statistically with those from the modified method of Schuller in patients with temporomandibular arthrosis. There was a significant difference between the images. These results demonstrated that this method of roentgenography may be useful in standardizing X-ray procedures, provides images of temporomandibular arthrosis of high reproductive quality, suggesting that this method may be adequate for more definitive diagnoses.

  7. A basic and clinical evaluation of our newly developed radiographic orthopantomography in studying the TMJ

    International Nuclear Information System (INIS)

    Takagi, Sumio

    1987-01-01

    Temporomandibular arthrosis has been reported in many fields: oral surgery, dental prosthetics, otolaryngology, radiology, psychosomatic medicine etc... Roentgenographic examination plays an important role in the diagnosis of temporomandibular arthrosis. There have been studies on various types of roentgenography of the temporomandibular joint, but because its anatomical morphology is so complicated that it is difficult to obtain an adequate roentgenograph. Thus, no definite method of roentgenography has been clearly established. We developed a new method of roentgenography that takes advantage of the characteristics of orthopantomography, and analyzed our results statistically. The following results were obtained: 1) As conditions for roentgenography, the optimal tube voltage was 60 ∼ 75 KVp, but this varied according to sex and age; the optimal tube current was 15 mA. 2) The optimal position of the head in the anteroposterior position was 10 mm in front of the standard point, and that in the vertical position was the central part of the film. 3) The optimal position of the head was reached when the OM line was horizontal. 4) On the basis of the data obtained from these basic experiments, images from standard roentgenography were compared statistically with those from the modified method of Schuller in patients with temporomandibular arthrosis. There was a significant difference between the images (P < 0.01). These results demonstrated that this method of roentgenography may be useful in standardizing X-ray procedures, provides images of temporomandibular arthrosis of high reproductive quality, suggesting that this method may be adequate for more definitive diagnoses. (author)

  8. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  9. Evaluation of lioxasol for the treatment of accidental local radiation injuries: an experimental and clinical study

    International Nuclear Information System (INIS)

    Nadejina, N.M.; Gusev, I.A.; Protasova, T.G.; Hopewell, J.W.; Rezvani, M.; Morris, G.M.; Chelmodaeva, T.E.; Fetisova, N.I.; Shagalov, L.B.

    1996-01-01

    The Chernobyl accident caused the development of Acute Radiation Syndrome (ARS) in 134 individuals, these were either treated at Hospital 6 (Moscow) or in hospitals in Kiev. Local radiation injuries (LRI) were found in 54 patients from the 108 ARS patients treated in Moscow over the acute period; 2 additional patients from this group had combined radiation and thermal skin injuries (the total number of LRI patients was 56). The effectiveness of Lioxasol, an ethyl alcohol based product containing 2-alliloxoethanol, was investigated in these patients. The treatment group was composed of 8 survivors of ARS with a second degree LRI caused by relatively uniform gamma-beta exposure. The control group was composed of 8 patients suffering from ARS also of second degree (7 patients) or first degree (1 patient) reactions caused by external, relatively uniform, gamma-beta exposure between 1956 and 1970. The time of re-epithelisation in the treated group was 25.4±3.1 days after irradiation. This was slightly shorter than the 28.3±4.9 days in the control group. However, this difference was not statistically significant (p>0.05). The effectiveness of Lioxasol was further studied on pig skin. Multiple sites in the same animal were irradiated with 22.5 mm diameter 90 Sr/ 90 Y plaques. The time of onset of moist desquamation and the subsequent healing times were used as end points. Following a single dose of 35 Gy, a dose known to produce moist desquamation in all irradiated sites, Lioxasol was applied topically twice a day. Lioxasol treatment (twice daily), which started the day after irradiation, delayed the time of onset of moist desquamation significantly from 5.1±0.2 weeks to 5.5±0.2 weeks. However, the most marked effect was on the number of sites that healed within 3 weeks of the first appearance of moist desquamation. This was 80±10.3% for sites treated with lioxasol whereas in untreated sites only 26.7±11.4% of the irradiated fields were healed by this time (p 3 H

  10. Evaluation of different ranges of LH:FSH ratios in polycystic ovarian syndrome (PCOS) - Clinical based case control study.

    Science.gov (United States)

    Malini, N A; Roy George, K

    2018-05-01

    Polycystic ovary syndrome (PCOS) is a highly prevalent endocrine and metabolic disorder among reproductive aged women, leading to infertility. One of the common clinical manifestations in PCOS is that there is a difference in the range of LH production in different case of PCOS and accordingly variability in LH:FSH ratio was observed. The aim of the present study was to evaluate different ranges of LH:FSH ratios in PCOS. In this cross sectional study, a consecutive series of 745 women (aged 28.11 ± 0.2) who were subjected to infertility treatment at specialist infertility clinics in central Travancore region were considered. About 50 healthy females (aged 27.58 ± 0.4) with regular menstrual cycles were regarded as control. The data were collected from hospital records using subject's written informed consent. PCOS patients were observed to have different ranges of LH:FSH ratios from PCOS. Copyright © 2018 Elsevier Inc. All rights reserved.

  11. Evaluation of student nurses' perception of preparedness for oral medication administration in clinical practice: a collaborative study.

    Science.gov (United States)

    Aggar, Christina; Dawson, Sonja

    2014-06-01

    Attainment of oral medication administration skills and competency for student nurses is challenging and medication errors are common. The ability of nurses to master a clinical skill is dependent upon educational instruction and practice. The aim of this study was to evaluate nursing students' perception of preparedness for oral medication administration in two practice environments and determine possible relationship between student demographics and their perceived preparedness for oral medication administration. This was a cross sectional, exploratory study. Eighty-eight second year students from a baccalaureate nursing course from two metropolitan Australian tertiary institutions participated. Student nurses' perception of preparedness for oral medication administration was measured via a self-administered, adapted, and validated questionnaire. The overall mean Total Preparedness Score was 86.2 (range 71-102). There was no significant difference for perceived total preparedness to administer oral medications between the two facilities. Whilst there was no significant relationship established between student demographics and their perceived preparedness to administer oral medications, four single questions related to clinical practice were shown to be significant. Low fidelity simulated teaching environments that incorporate time management and post medication situations, may improve student nurses' perceived preparedness for oral medication administration. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Gynecomastia: Clinical evaluation and management

    Science.gov (United States)

    Cuhaci, Neslihan; Polat, Sefika Burcak; Evranos, Berna; Ersoy, Reyhan; Cakir, Bekir

    2014-01-01

    Gynecomastia is the benign enlargement of male breast glandular tissue and is the most common breast condition in males. At least 30% of males will be affected during their life. Since it causes anxiety, psychosocial discomfort and fear of breast cancer, early diagnostic evaluation is important and patients usually seek medical attention. Gynecomastia was reported to cause an imbalance between estrogen and androgen action or an increased estrogen to androgen ratio, due to increased estrogen production, decreased androgen production or both. Evaluation of gynecomastia must include a detailed medical history, clinical examination, specific blood tests, imaging and tissue sampling. Individual treatment requirements can range from simple reassurance to medical treatment or even surgery. The main aim of any intervention is to relieve the symptoms and exclude other etiological factors. PMID:24741509

  13. Gynecomastia: Clinical evaluation and management

    Directory of Open Access Journals (Sweden)

    Neslihan Cuhaci

    2014-01-01

    Full Text Available Gynecomastia is the benign enlargement of male breast glandular tissue and is the most common breast condition in males. At least 30% of males will be affected during their life. Since it causes anxiety, psychosocial discomfort and fear of breast cancer, early diagnostic evaluation is important and patients usually seek medical attention. Gynecomastia was reported to cause an imbalance between estrogen and androgen action or an increased estrogen to androgen ratio, due to increased estrogen production, decreased androgen production or both. Evaluation of gynecomastia must include a detailed medical history, clinical examination, specific blood tests, imaging and tissue sampling. Individual treatment requirements can range from simple reassurance to medical treatment or even surgery. The main aim of any intervention is to relieve the symptoms and exclude other etiological factors.

  14. Building clinical networks: a developmental evaluation framework.

    Science.gov (United States)

    Carswell, Peter; Manning, Benjamin; Long, Janet; Braithwaite, Jeffrey

    2014-05-01

    Clinical networks have been designed as a cross-organisational mechanism to plan and deliver health services. With recent concerns about the effectiveness of these structures, it is timely to consider an evidence-informed approach for how they can be developed and evaluated. To document an evaluation framework for clinical networks by drawing on the network evaluation literature and a 5-year study of clinical networks. We searched literature in three domains: network evaluation, factors that aid or inhibit network development, and on robust methods to measure network characteristics. This material was used to build a framework required for effective developmental evaluation. The framework's architecture identifies three stages of clinical network development; partner selection, network design and network management. Within each stage is evidence about factors that act as facilitators and barriers to network growth. These factors can be used to measure progress via appropriate methods and tools. The framework can provide for network growth and support informed decisions about progress. For the first time in one place a framework incorporating rigorous methods and tools can identify factors known to affect the development of clinical networks. The target user group is internal stakeholders who need to conduct developmental evaluation to inform key decisions along their network's developmental pathway.

  15. Improving clinical communication of students with English as a second language (ESL) using online technology: a small scale evaluation study.

    Science.gov (United States)

    Rogan, Fran; San Miguel, Caroline

    2013-09-01

    Increasingly, students with English as a second language (ESL) are enrolled in nursing degrees in English speaking countries (Wang et al., 2008). However, they may be at risk of clinical practice failure due to communication difficulties associated with unfamiliar linguistic and cultural factors (Guhde, 2003). This paper describes and evaluates an innovation to assist ESL nursing students at an Australian university develop their clinical communication skills and practice readiness by providing online learning resources, using podcast and vodcast technology, that blend with classroom activities and facilitate flexible and independent learning. The innovation builds on an intensive clinical language workshop program called 'Clinically Speaking' which has evolved through a cyclical process of ongoing research to produce resources in response to students' learning needs. Whilst uptake of the resources was modest, students of ESL as well as English speaking backgrounds (ESB) found the resources improved their clinical preparation and confidence by increasing their understanding of expectations, clinical language and communication skills. The innovation, developed with a modest budget, shows potential in developing ESL and ESB students' readiness for clinical communication, enabling them to engage in clinical practice to develop competency standards required of nursing graduates and registration authorities. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Videoconferencing for site initiations in clinical studies: Mixed methods evaluation of usability, acceptability, and impact on recruitment.

    Science.gov (United States)

    Randell, Rebecca; Backhouse, Michael R; Nelson, E Andrea

    2016-12-01

    A critical issue for multicentre clinical studies is conducting site initiations, ensuring sites are trained in study procedures and comply with relevant governance requirements before they begin recruiting patients. How technology can support site initiations has not previously been explored. This study sought to evaluate use of off-the-shelf web-based videoconferencing to deliver site initiations for a large national multicentre study. Participants in the initiations, including podiatrists, diabetologists, trial coordinators, and research nurses, completed an online questionnaire based on the System Usability Scale (SUS) (N = 15). This was followed by semi-structured interviews, with a consultant diabetologist, a trial coordinator, and three research nurses, exploring perceived benefits and limitations of videoconferencing. The mean SUS score for the videoconferencing platform was 87.2 (SD = 13.7), suggesting a good level of usability. Interview participants perceived initiations delivered by videoconferencing as being more interactive and easier to follow than those delivered by teleconference. In comparison to face-to-face initiations, videoconferencing takes less time, easily fitting in with the work of staff at the local sites. Perceptions of impact on communication varied according to the hardware used. Off-the-shelf videoconferencing is a viable alternative to face-to-face site initiations and confers advantages over teleconferencing.

  17. Evaluation of functional outcome of pilon fractures managed with limited internal fixation and external fixation: A prospective clinical study.

    Science.gov (United States)

    Meena, Umesh Kumar; Bansal, Mahesh Chand; Behera, Prateek; Upadhyay, Rahul; Gothwal, Gyan Chand

    2017-11-01

    The management of pilon fractures is controversial primarily due to the high rate of complications irrespective of the mode of treatment. Limited internal fixation with external fixation is associated with minimal soft tissue handling. This may reduce the chances of wound dehiscence and infection. This study was designed to evaluate the functional and clinical outcomes in patients treated with limited internal fixation combined with external fixation in pilon fractures. This study was conducted as a prospective clinical study on 56 skeletally mature patients with closed fractures with poor skin condition, and with open grade 1 and grade 2 distal tibial intra-articular fractures. All patients were treated with combined limited internal fixation and ankle spanning external fixation. All fractures in this series united with an average time period of union of 18.3weeks (ranging from 13 weeks to 30 weeks). There was no non-union in any case. There was malunion in 4 cases, varus malunion (>5 degree) in 2 cases and recurvatum in another 2 cases). Excellent to good functional results were observed in 88% cases based on the modified Ovadia and Beals score. The mean ankle dorsiflexion and planter flexion movements were 10.2±5.3 degrees and 27.4±7.2 degrees respectively. infections occurred in 6 patients which included 4 pin tract infections and 2 superficial wound infection, all 6 healed after removal of pin tract and with oral antibiotics. The technique of combined external fixation with internal fixation is safe and effective management option for intra-articular distal tibial fractures.

  18. CLINICAL-EVALUATION OF PAIN TREATMENT WITH ELECTROSTIMULATION - A STUDY OF TENS IN PATIENTS WITH DIFFERENT PAIN SYNDROMES

    NARCIS (Netherlands)

    MEYLER, WJ; DEJONGSTE, MJL; ROLF, CAM

    Objective: We evaluated the clinical efficacy and the unwanted side effects of transcutaneous electrical nerve stimulation (TENS) in a consecutive group of patients with intractable pain due to different pain syndromes. Methods: Two hundred eleven patients with different pain syndromes, coded

  19. Evaluating clinical librarian services: a systematic review.

    Science.gov (United States)

    Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

    2011-03-01

      Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

  20. Comparative evaluation of diode laser ablation and surgical stripping technique for gingival depigmentation: A clinical and immunohistochemical study.

    Science.gov (United States)

    Bakutra, Gaurav; Shankarapillai, Rajesh; Mathur, Lalit; Manohar, Balaji

    2017-01-01

    There are various treatment modalities to remove the black patches of melanin pigmentation. The aim of the study is to clinically compare the diode laser ablation and surgical stripping technique for gingival depigmentation and to evaluate their effect on the histological changes in melanocyte activity. A total of 40 sites of 20 patients with bilateral melanin hyperpigmentation were treated with the surgical stripping and diode laser ablation technique. Change in Hedin index score, change in area of pigmentation using image analyzing software, pain perception, patient preference of treatment were recorded. All 40 sites were selected for immunohistochemical analysis using HMB-45 immunohistochemical marker. At 12 months post-operative visit, in all sites, repigmentation was observed with different grades of Hedin index. Paired t -test, analysis of variance, and Chi-square tests were used for statistical analysis. Repigmentation in surgical stripping is significantly lesser compared to laser ablation. Lesser numbers of melanocytes were found on immunohistological examination at 12 months postoperatively. Comparison for patient preference and pain indices give statistically significant values for diode laser techniques. Gingival hyperpigmentation is effectively managed by diode laser ablation technique and surgical stripping method. In this study, surgical stripping technique found to be better compared to diode laser ablation.

  1. Evaluation of empowerment model on indicators of metabolic control in patients with type 2 diabetes, a randomized clinical trial study.

    Science.gov (United States)

    Ebrahimi, Hossein; Sadeghi, Mahdi; Amanpour, Farzaneh; Vahedi, Hamid

    2016-04-01

    Diabetes education is a major subject in achieving optimal glycemic control. Effective empowerment approach can be beneficial for improving patients' health. The aim of this study was to evaluate the effect of empowerment model on indicators of metabolic control in patients with type 2 diabetes. a randomized controlled trial of 103 patients with type 2 diabetes were randomly assigned to either the intervention (empowerment approach training) or the control group (conventional training) 2014. Empowerment approach training were performed for the experimental group for eight weeks. Data collection tool included demographic information form and indicators of metabolic control checklist. Analysis was performed by one-way analysis of variance, chi-square test, paired t-test, independent t-test and multiple linear regression. Before the intervention, two groups were homogeneous in terms of demographic variables, glycosylated hemoglobin (HbA1C), and other indicators of metabolic control. After the intervention, average HbA1C and other metabolic indicators except for LDL showed significant differences in the experimental group compared to the control group. study results indicated the positive effects of applying the empowerment model on the metabolic control indicators. Therefore, applying this model is recommended to nurses and the relevant authorities in order to improve clinical outcomes in diabetic patients. Copyright © 2015 Primary Care Diabetes Europe. Published by Elsevier Ltd. All rights reserved.

  2. Hepatitis C and Oral Lichen Planus: Evaluation of their Correlation and Risk Factors in a Longitudinal Clinical Study.

    Science.gov (United States)

    De Carli, João Paulo; Linden, Maria Salete Sandini; da Silva, Soluete Oliveira; Trentin, Micheline Sandini; Matos, Felipe de Souza; Paranhos, Luiz Renato

    2016-01-01

    The aim of this study is to evaluate the correlation between hepatitis C virus (HCV) infection and oral lichen planus (OLP), and further examine the relationship between age, sex, systemic diseases and drugs with the presence of HCV infection or OLP. A longitudinal clinical study was carried out from March 2010 to December 2013 with 51 individuals, of whom 33 had been presented with HCV (HCV-positive group) and 18 had OLP (OLP-positive group), in Passo Fundo, RS, Brazil. Hepatitis C virus-positive individuals who presented lesions compatible with OLP were subjected to an intraoral biopsy for histopathological diagnosis, while OLP-positive individuals underwent anti-HCV serological test for diagnosis of HCV infection. Data on age, sex, systemic diseases and drugs used were recorded for later analysis. The data were analyzed using descriptive statistics of frequency and by Pearson's Chi-square test, with a 5% significance level (p 0.05). There was a significant relationship between HCV infection and manifestation of OLP. Age, sex, systemic diseases and drugs were not identified as risk factors for the development of these diseases. The OLP could serve as an indicative of HCV infection in asymptomatic patients, thus enabling early diagnosis and treatment of hepatitis and hence, a better prognosis.

  3. Evaluation of 316 narrow diameter implants followed for 5-10 years: a clinical and radiographic retrospective study.

    Science.gov (United States)

    Arisan, Volkan; Bölükbaşi, Nilüfer; Ersanli, Selim; Ozdemir, Tayfun

    2010-03-01

    Narrow diameter implants (NDIs; diameter >3.75 mm) are useful in replacement of missing incisor teeth and when the bucco-lingual width of the edentulous crest is insufficient. The present study evaluated the success and survival rates, peri-implant parameters, mechanical and prosthetic post-loading complications of NDIs followed over a 10-year period. Three hundred and sixteen NDIs were inserted into 139 patients and restored with 120 prostheses. Clinical and radiographic assessment data were collected during recall visits. Implant success (SC), cumulative survival rate (CSR), marginal bone loss (MBL), peri-implant conditions and prosthetic complications were assessed. Cox proportional hazards regression analysis, Kaplan-Meier survival curves with the log-rank test and life table analysis were used to evaluate the outcome of NDIs within comparable subgroups. MBL and peri-implant parameters measured annually were further analyzed. The mean follow-up time was 9.1 years (range: 60-124 months). Twelve implants were lost in the healing phase and two during function. The mean MBL in the maxilla and the mandible was 1.32 +/- 0.13 and 1.28 +/- 0.3 mm, respectively, after 10 years. SC and CSR were 91.4% and 92.3%, respectively, after 124 months. Smoking and posterior localization were associated with an increased risk of failure. Cement loosening (16.8%) was the most common prosthetic complication. No implants were fractured. NDIs can be used with confidence where a regular diameter implant is not suitable. MBL around NDIs occurred predominantly within 2 years of loading and was minimal thereafter. Further studies are required to clarify the possible risks associated with smoking and posterior placement.

  4. [Geriatric Trauma Center DGU®: Evaluation of clinical and economic parameters : A pilot study in a german university hospital].

    Science.gov (United States)

    Knobe, M; Böttcher, B; Coburn, M; Friess, T; Bollheimer, L C; Heppner, H J; Werner, C J; Bach, J-P; Wollgarten, M; Poßelt, S; Bliemel, C; Bücking, B

    2018-04-19

    Previous studies on orthogeriatric models of care suggest that there is substantial variability in how geriatric care is integrated in the patient management and the necessary intensity of geriatric involvement is questionable. The aim of the current prospective cohort study was the clinical and economic evaluation of fragility fracture treatment pathways before and after the implementation of a geriatric trauma center in conformity with the guidelines of the German Trauma Society (DGU). A comparison of three different treatment models (6 months each) was performed: A: Standard treatment in Orthopaedic Trauma; B: Special care pathways with improvement of the quality management system and implementation of standard operating procedures; C: Interdisciplinary treatment with care pathways and collaboration with geriatricians (ward round model). In the 151 examined patients (m/w 47/104; 83.5 (70-100) years; A: n = 64, B: n = 44, C: n = 43) pathways with orthogeriatric comanagement (C) improved frequency of postoperative mobilization (p = 0.021), frequency of osteoporosis prophylaxis (p = 0.001) and the discharge procedure (p = 0.024). In comparison to standard treatment (A), orthogeriatric comanagement (C) was associated with lower rates of mortality (9% vs. 2%; p = 0.147) and cardio-respiratory complications (39% vs. 28%; p = 0.235) by trend. In this context, there were low rates of myocardial infarction (6% vs. 0%), dehydration (6% vs. 0%), cardiac dysrhythmia (8% vs. 0%), pulmonary decompensation (28% vs. 16%), electrolyt dysbalance (34% vs. 19%) and pulmonary edema (11% vs. 2%). Duration of stay in an intensive care unit was 29 h (A) and 18 h (C) respectively (p = 0.205), with consecutive reduction in costs. A sole establishment of a special care pathway for older hip fracture patients (B) showed a lower rate of myocardial infarction (A: 11%, B: 0%, C: 0%; p = 0.035). There was a clear tendency to a better overall

  5. A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

    Science.gov (United States)

    Cheng, Steven K; Dietrich, Mary S; Dilts, David M

    2010-11-15

    Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. ©2010 AACR.

  6. How well does Invisalign work? A prospective clinical study evaluating the efficacy of tooth movement with Invisalign.

    Science.gov (United States)

    Kravitz, Neal D; Kusnoto, Budi; BeGole, Ellen; Obrez, Ales; Agran, Brent

    2009-01-01

    The purpose of this prospective clinical study was to evaluate the efficacy of tooth movement with removable polyurethane aligners (Invisalign, Align Technology, Santa Clara, Calif). The study sample included 37 patients treated with Anterior Invisalign. Four hundred one anterior teeth (198 maxillary and 203 mandibular) were measured on the virtual Treat models. The virtual model of the predicted tooth position was superimposed over the virtual model of the achieved tooth position, created from the posttreatment impression, and the 2 models were superimposed over their stationary posterior teeth by using ToothMeasure, Invisalign's proprietary superimposition software. The amount of tooth movement predicted was compared with the amount achieved after treatment. The types of movements studied were expansion, constriction, intrusion, extrusion, mesiodistal tip, labiolingual tip, and rotation. The mean accuracy of tooth movement with Invisalign was 41%. The most accurate movement was lingual constriction (47.1%), and the least accurate movement was extrusion (29.6%)- specifically, extrusion of the maxillary (18.3%) and mandibular (24.5%) central incisors, followed by mesiodistal tipping of the mandibular canines (26.9%). The accuracy of canine rotation was significantly lower than that of all other teeth, with the exception of the maxillary lateral incisors. At rotational movements greater than 15 degrees, the accuracy of rotation for the maxillary canines fell significantly. Lingual crown tip was significantly more accurate than labial crown tip, particularly for the maxillary incisors. There was no statistical difference in accuracy between maxillary and mandibular teeth of the same tooth type for any movements studied. We still have much to learn regarding the biomechanics and efficacy of the Invisalign system. A better understanding of Invisalign's ability to move teeth might help the clinician select suitable patients for treatment, guide the proper sequencing of

  7. Clinical evaluation of patients with benign prostatic hyperplasia, treated with the natural product Calprost®: a randomized, controlled study

    Directory of Open Access Journals (Sweden)

    Magnelis Machado-Leiva

    2016-10-01

    Full Text Available Context: Benign Prostatic Hyperplasia (BPH is a common disease that course with Lower Urinary Tract Symptoms (LUTS, mainly in over 50 years-old men. Commonly indicated drugs such as alpha adrenergic-blockers are life-treatment with some adverse reactions. Center for Drug Research and Development produce a microencapsulated lipophilic extract of pumpkin seed oil (Calprost® with anti-androgenic, anti-inflammatory, antioxidant, antiproliferative and diuretic properties. Aims: To evaluate the effect and safety of Calprost® in patients with BPH and LUTS. Methods: A multicenter, randomized, controlled, open exploratory clinical trial was conducted. Two experimental groups, study group (Calprost®, 140 mg daily (n=81, and control group (terazosin, 2 mg daily (n=50 were conformed. All the patients were treated during three months. Efficacy was evaluated through International Prostate Symptoms Score (IPSS, residual bladder volume and prostate volume. Results: Most of the included patients (74.0% were white skin color and their mean age was 66 yrs. Fifteen patients, nine of them from terazosin group, withdraw the trial voluntarily. A significant reduction in the overall IPSS scale was obtained for both groups. Nevertheless, some obstructive (intermittency, straining and irritative (frequency, urgency urinary symptoms decreased more markedly in the Calprost® group being milder. Median residual and prostatic volumes decreased significantly (p=0.048 and p=0.002, respectively only into the Calprost® group. Most of the adverse events were recorded in the terazosin group (79.4%, where postural hypotension prevailed. Conclusions: The natural product Calprost® was probed as a successful treatment of patients with BPH/LUTS, being also well-tolerated.

  8. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. 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.

  9. Experimental evaluation of clinical colon anastomotic leakage.

    Science.gov (United States)

    Pommergaard, Hans-Christian

    2014-03-01

    Colorectal anastomotic leakage remains a frequent and serious complication in gastrointestinal surgery. Patient and procedure related risk factors for anastomotic leakage have been identified. However, the responsible pathophysiological mechanisms are still unknown. Among these, ischemia and insufficient surgical technique have been suggested to play a central role. Animal models are valuable means to evaluate pathophysiological mechanisms and may be used to test preventive measures aiming at reducing the risk of anastomotic leakage, such as external anastomotic coating. The aim of this thesis was to: Clarify the best suited animal to model clinical anastomotic leakage in humans; Create animal models mimicking anastomotic leakage in humans induced by insufficient surgical technique and tissue ischemia; Determine the best suited coating materials to prevent anastomotic leakage. This study is a systematic review using the databases MEDLINE and Rex. MEDLINE was searched up to October 2010 to identify studies on experimental animal models of clinical colon anastomotic leakage. From the Rex database, textbooks on surgical aspects as well as gastrointestinal physiology and anatomy of experimental animals were identified. The results indicated that the mouse and the pig are the best suited animals to evaluate clinical anastomotic leakage. However, the pig model is less validated and more costly to use compared with the mouse. Most frequently, rats are used as models. However, extreme interventions are needed to create clinical leakage in these animals. The knowledge from this study formed the basis for selecting the animal species most suited for the models in the next studies. STUDY 2: In this experimental study, technically insufficient colonic anastomoses were performed in 110 C57BL/6 mice. The number of sutures in the intervention group was reduced to produce a suitable leakage rate. Moreover, the analgesia and suture material were changed in order to optimize the

  10. [Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study].

    Science.gov (United States)

    Lehmkuhl, D; Meissner, W; Neugebauer, E A M

    2011-09-01

    Demonstration of improved postoperative pain management by implementation of the S3 guidelines on treatment of acute perioperative and posttraumatic pain, by the integrated quality management concept "quality management acute pain" of the TÜV Rheinland or by participation in the benchmark project "Quality improvement in postoperative pain management" (QUIPS). A prospective controlled study (pre-post design) was carried out in hospitals with various levels of care comparing three hospital groups (n = 17/7/3, respectively). Group 1: participation in the QUIPS project (intraclinic and interclinic comparison of outcome data of postoperative pain treatment), group 2: participation in the quality management acute pain program (certified by TÜV Rheinland), group 3: control group with no involvement in either of the two concepts. In all three groups, an anonymous data collection was performed consisting of patient-reported pain intensity, side effects, pain disability and patient satisfaction. Pain therapy intervention was carried out only in group 2 by an integrated quality management concept (certification project: Quality management acute pain) with a package of measures to improve structure, process and outcome quality. The TÜV Rheinland certified clinics (group 2) showed a significant improvement in the pre-post comparison (before versus after certification) in the areas maximum pain (from visual analogue scale VAS 4.6 to 3.7), stress pain (5.3 to 3.9), pain-related impairment (proportion of patients with pain-linked decreased mobility and movement 26% to 16.1%, coughing and breathing 23.1% to 14.3%) and patient satisfaction (from 13.2 to 13.7; scale 0 completely unsatisfied, 15 very satisfied). The clinics with participation in QUIPS for 2 years also showed a significant improvement in stress pain (numeric rating scale NRS for pain 4.5 to 4.2), pain-linked-limitation of coughing and breathing (28% to 23.6%), and patient satisfaction (from 11.9 to 12.4). There were

  11. Prolactinomas : clinical studies

    NARCIS (Netherlands)

    Kars, Marleen

    2008-01-01

    Prolactinoma are treated with dopamine agonists, which are effective in reducing prolactin and tumor size. Studies reporting clinical and radiological outcome are scarce. The study described in chapter 2, assesses long-term outcome in patients treated with dopamine agonists for macroprolactinoma. An

  12. Evaluation of dynamic infrared thermography as an alternative to CT angiography for perforator mapping in breast reconstruction: a clinical study

    International Nuclear Information System (INIS)

    Weum, Sven; Mercer, James B.; Weerd, Louis de

    2016-01-01

    The current gold standard for preoperative perforator mapping in breast reconstruction with a DIEP flap is CT angiography (CTA). Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing radiation or contrast injection. We evaluated if DIRT could be an alternative to CTA in perforator mapping. Twenty-five patients scheduled for secondary breast reconstruction with a DIEP flap were included. Preoperatively, the lower abdomen was examined with hand-held Doppler, DIRT and CTA. Arterial Doppler sound locations were marked on the skin. DIRT examination involved rewarming of the abdominal skin after a mild cold challenge. The locations of hot spots on DIRT were compared with the arterial Doppler sound locations. The rate and pattern of rewarming of the hot spots were analyzed. Multiplanar CT reconstructions were used to see if hot spots were related to perforators on CTA. All flaps were based on the perforator selected with DIRT and the surgical outcome was analyzed. First appearing hot spots were always associated with arterial Doppler sounds and clearly visible perforators on CTA. The hot spots on DIRT images were always slightly laterally located in relation to the exit points of the associated perforators through the rectus abdominis fascia on CTA. Some periumbilical perforators were not associated with hot spots and showed communication with the superficial inferior epigastric vein on CTA. The selected perforators adequately perfused all flaps. This study confirms that perforators selected with DIRT have arterial Doppler sound, are clearly visible on CTA and provide adequate perfusion for DIEP breast reconstruction. Retrospectively registered at ClinicalTrials.gov with identifier NCT02806518

  13. The evaluation of clinical usefulness of transbrochoscopic lung biopsy in undefined interstitial lung diseases: a retrospective study.

    Science.gov (United States)

    Han, Qian; Luo, Qun; Chen, Xiaobo; Xie, Jiaxing; Wu, Lulu; Chen, Rongchang

    2017-03-01

    Previous studies mostly focused on the diagnostic accuracy of transbronchoscopic lung biopsy (TBLB) in the diagnosis of interstitial lung diseases (ILDs). We aimed to explore the clinical usefulness of TBLB results in the diagnostic procedure of undefined ILDs. The retrospective analysis included patients undergoing TBLB for the diagnosis of undefined ILDs from January 2007 to December 2010. The clinically useful TBLB was defined as that lead to a specific histopathological diagnosis or that was consistent with the working diagnosis based on existing clinical and radiological data. A total of 664 patients were included in the study. TBLB failed to obtain lung parenchyma in 155 cases (23.3%). TBLB was considered clinically helpful in 202 procedures (30.4%), including 114 cases that provided definitive histopathological diagnoses and 88 cases that were consistent with working diagnoses. Among 202 cases of clinically useful TBLBs, the majority were diagnosed as pulmonary alveolar proteinosis (PAP) (67 cases, 33.2%), connective tissue disease-related ILDs (CTD-ILDs) (65, 32.2%) and idiopathic pulmonary fibrosis (IPF) (33, 16.3%). Although TBLB could provide definitive histopathological diagnoses in all cases diagnosed as PAP, only few cases of IPF (7, 21.2% of IPF diagnoses) and CTD-ILDs (9, 13.8% of CTD-ILD diagnoses) could be identified by TBLBs. The clinical usefulness of TBLB, in conjunction with thorough clinical and radiological data, in the diagnosis of ILDs may be varied depending on different subtypes. The use of histopathological analysis and the type of biopsy employed should therefore be considered on a case-by-case basis. © 2015 John Wiley & Sons Ltd.

  14. A comparative evaluation of static and functional methods for recording centric relation and condylar guidance: a clinical study.

    Science.gov (United States)

    Thakur, Mridul; Jain, Veena; Parkash, Hari; Kumar, Pravesh

    2012-09-01

    To evaluate and compare the centric relation and horizontal condylar guidance using interocclusal wax and extra oral Gothic arch methods and subjective evaluation of dentures thus fabricated. Centric relation and horizontal condylar guidance was recorded by using interocclusal wax and gothic arch tracing in 28 completely edentulous patients. These records were transferred to the articulator and difference in both values was recorded. After that patients were divided in two groups according to the centric relation and horizontal condylar guidance recording method used to achieve balanced occlusion. Response of the dentures was subjectively evaluated using "Woelfel subjective evaluation criteria". Centric relation recorded by both the methods did coincide in 7.14 % of patients. Centric relation recorded by interocclusal wax was posterior to Gothic centric relation in 21.43 % of patients, and anterior to Gothic centric relation in 71.42 % patients. Gothic arch tracings gave higher mean guidance values on both the sides as compared to protrusive wax record in all the subjects, although the difference was statistically insignificant (P > 0.05). Subjective evaluation showed statistical insignificance for all the parameters in both groups. Gothic arch method records the centric relation at a more posterior position than the Static method, but it does not make any difference in clinical performance of the complete denture. Horizontal condylar guidance angle was approximately similar by both the methods.

  15. Clinico-pathological study to evaluate oral lichen planus for the establishment of clinical and histopathological diagnostic criteria.

    Science.gov (United States)

    Hiremath, Santhosh; Kale, Alka D; Hallikerimath, Seema

    2015-01-01

    Lichen planus and lichenoid lesions affecting the oral cavity show similar clinico-pathological features creating a diagnostic dilemma. Hence, the aim of the present study was to establish a clinical and histopathological correlation in the diagnosis of oral lichen planus, based on the modified WHO diagnostic criteria of oral lichen planus and oral lichenoid lesions proposed by Van der Meij and Van der Waal in 2003. In the present study, 100 cases of oral lichen planus were clinically and histopathologically analyzed. Out of the 100 cases, 50 were prospective and 50 were retrospective cases. Prospective cases were collected based on the clinical diagnosis of oral lichen planus and oral lichenoid lesion. Retrospective cases were collected based on the histopathological diagnosis of oral lichen planus. Both the clinical and histopathological analyses were performed based on a proposal for a set of modified diagnostic criteria of oral lichen planus and oral lichenoid lesion. A final diagnosis of oral lichen planus was made only after the correlation of the clinical diagnosis with the histopathological diagnosis. The interobserver agreement among three observers for both prospective and retrospective cases in the final diagnosis of oral lichen planus was found to be "good" to "very good" indicating high reproducibility. However, the final diagnoses of true oral lichen planus after clinico-pathological correlation in prospective and retrospective study groups appeared to be 38.0% and 54.0% respectively. The results of the present study revealed mild to moderate clinico-pathological correlation in the final diagnosis of oral lichen planus for the prospective and retrospective study groups respectively.

  16. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study

    Directory of Open Access Journals (Sweden)

    Vimi George

    2015-01-01

    Full Text Available Objectives: Clinical and radiographic effects of mineral trioxide aggregate (white MTA and calcium hydroxide (Dycal in indirect pulp treatment (IPT of primary teeth over a period of 6 months. Materials and Methods: A clinical trial with sample size of 40 primary molars between the age group of 5-9 years, of which, 20 teeth were considered, each for MTA and Dycal. Measurements on the digitized radiographs were performed at baseline, third and sixth month, increase in dentin was then measured using Corel Draw software. Result: Independent t-test had indicated that at the end of 3 months and 6 months, a statistically significant increase in dentin thickness with both MTA and Dycal (P-value ≤ 0.001 was found. Within the MTA group, the thickness of dentin formed was 0.089 mm ± 0.031 mm at first 3 months and 0.055 ± 0.022 mm at the second 3 months, (P ≤ 0.001 evaluated using paired t-test. In the Dycal group, increment in dentin deposited was 0.068 mm at the first 3 months and second 3 months, it was 0.030 mm (P-value ≤ 0.001. Conclusion: Clinically and radiographically, MTA is superior to Dycal as a good IPT medicament in primary teeth.

  17. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study).

    Science.gov (United States)

    George, Vimi; Janardhanan, Suresh Kumar; Varma, Balagopal; Kumaran, Parvathy; Xavier, Arun Mamachan

    2015-01-01

    Clinical and radiographic effects of mineral trioxide aggregate (white MTA) and calcium hydroxide (Dycal) in indirect pulp treatment (IPT) of primary teeth over a period of 6 months. A clinical trial with sample size of 40 primary molars between the age group of 5-9 years, of which, 20 teeth were considered, each for MTA and Dycal. Measurements on the digitized radiographs were performed at baseline, third and sixth month, increase in dentin was then measured using Corel Draw software. Independent t-test had indicated that at the end of 3 months and 6 months, a statistically significant increase in dentin thickness with both MTA and Dycal (P-value ≤ 0.001) was found. Within the MTA group, the thickness of dentin formed was 0.089 mm ± 0.031 mm at first 3 months and 0.055 ± 0.022 mm at the second 3 months, (P ≤ 0.001) evaluated using paired t-test. In the Dycal group, increment in dentin deposited was 0.068 mm at the first 3 months and second 3 months, it was 0.030 mm (P-value ≤ 0.001). Clinically and radiographically, MTA is superior to Dycal as a good IPT medicament in primary teeth.

  18. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: an empirical study.

    Science.gov (United States)

    Chima, Sylvester C

    2013-01-01

    Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while

  19. Evaluation of mid- and long-term consequences, clinical and social performance in Chernobyl acute radiation syndrome patients in a multi-centre clinical follow-up study

    International Nuclear Information System (INIS)

    Weiss, M.; Fischer, B.; Fliedner, T.M.; Bebeshko, V.G.; Belyi, D.A.; Kovalenko, A.N.; Nadejina, N.M.; Galstian, I.A.

    1996-01-01

    Since the Chernobyl accident in 1986 nearly all survivors (n=199) of 237 patients with suspected acute radiation syndrome (ARS) underwent regular follow-up investigations in the scientific centres in Kiev and in Moscow. In a close collaboration with these centres we investigate the health status of this population in a five step approach. An integral part of this approach to patient evaluation and analysis of the mid- and long-term consequences of the Chernobyl accident is a 'Questionnaire for clinical, laboratory and functional follow-up of radiation-exposed persons', developed with these centres. Beyond this project we report as an interim some results of analyses performed by the scientific centers in Kiev and in Moscow about disorders of the cardiovascular system and the digestive tract, formation of cataract, generalized and local skin injuries and/or disorders as well as for a subpopulation (n=89) the Karnofsky performance score and working ability

  20. Phase 2 clinical study of 123I-IBF, a dopamine D2 receptor imaging agent, to evaluate clinical efficacy and safety in Parkinson's disease and Parkinson syndromes

    International Nuclear Information System (INIS)

    Torizuka, Kanji; Mizuno, Yoshikuni; Kubo, Atsushi

    1999-01-01

    A Phase 2 multicenter trial of 123 I-IBF, (S)-5-iodo-7-N-[(1-ethyl-2-pyrrolidinyl)methyl] carboxamido-2,3-dihydrobenzofuran, was conducted to evaluate its clinical efficacy and safety in 158 patients with Parkinson's disease (PD) or Parkinson syndromes (PS). SPECT data were acquired at two hours (2H-SPECT), after intravenous injection of 123 I-IBF (167 MBq). Additional SPECT scan at three hours (3H-SPECT) and dynamic SPECT scan at most until one hour were performed when possible. No severe side effects due to 123 I-IBF injection were observed. The sensitivity, specificity and accuracy for discriminating PS from PD using the striatal specific binding count-to-frontal cortex count ratio (St/Fc-1) in 3H-SPECT were 72.7%, 81.0% and 78.1% in 64 clinically definite cases (i.e., typical cases), respectively. The putamen-to-caudate ratios were significantly lower in striatonigral degeneration compared with those in PD. The contralateral-to-ipsilateral ratios against the symptomatic side of tremor and/or rigidity in the patients with PD (Hoehn and Yahr I) were significantly higher than the left-to-right ratios in the normal controls. St/Fc-1 in 3H-SPECT was significantly lower in the patients showing a poor response to levodopa than in those showing a good response. The dopamine D 2 receptor binding potential (k 3 /k 4 ), obtained by dynamic SPECT based on compartment model analysis, correlated well with the striatal specific binding count-to-occipital cortex count ratio. These results suggest that 123 I-IBF is a promising agent for differential diagnosis and pathophysiological evaluation of PD and PS. (author)

  1. Clinical evaluation of patients with patellofemoral disorders.

    Science.gov (United States)

    Post, W R

    1999-01-01

    Accurate clinical evaluation of patients with patellofemoral disorders is the cornerstone of effective treatment. This article defines how a careful history and physical examination can direct strategies for nonoperative and operative management. A critical analysis of traditional methods of evaluation and a streamlined rational approach to clinical evaluation is presented. Key questions and important physical findings that affect treatment decisions are emphasized.

  2. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds

    DEFF Research Database (Denmark)

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne

    2011-01-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated...... events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds....

  3. A pilot study to evaluate the safety and clinical performance of Leucopatch, an autologous, additive-free, platelet-rich fibrin for the treatment of recalcitrant chronic wounds

    DEFF Research Database (Denmark)

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne

    2011-01-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated...

  4. A CLINICAL STUDY TO EVALUATE THE ROLE OF AKSHITARPANA, SHIRODHARA AND AN AYURVEDIC COMPOUND IN CHILDHOOD COMPUTER VISION SYNDROME

    OpenAIRE

    Singh Omendra Pal; Singh Laxmi; Kumar Abhimanyu

    2011-01-01

    Computer vision syndrome is one among the lifestyle disorders in children. About 88% of people who use computers everyday suffer from this problem and children are no exception. Computer Vision Syndrome (CVS) is the complex of eye and vision problems related to near works which are experienced during the use of Video Display Terminals (TV and computers). Therefore, considering these prospects a randomized double blind placebo control study was conducted among 40 clinically diagnosed children ...

  5. Scaling-up access to antiretroviral therapy for children: a cohort study evaluating care and treatment at mobile and hospital-affiliated HIV clinics in rural Zambia.

    Directory of Open Access Journals (Sweden)

    Janneke H van Dijk

    Full Text Available Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART, but few programs have been evaluated. We compared outcomes for children receiving care in mobile and hospital-affiliated HIV clinics in rural Zambia.Outcomes were measured within an ongoing cohort study of HIV-infected children seeking care at Macha Hospital, Zambia from 2007 to 2012. Children in the outreach clinic group received care from the Macha HIV clinic and transferred to one of three outreach clinics. Children in the hospital-affiliated clinic group received care at Macha HIV clinic and reported Macha Hospital as the nearest healthcare facility.Seventy-seven children transferred to the outreach clinics and were included in the analysis. Travel time to the outreach clinics was significantly shorter and fewer caretakers used public transportation, resulting in lower transportation costs and fewer obstacles accessing the clinic. Some caretakers and health care providers reported inferior quality of service provision at the outreach clinics. Sixty-eight children received ART at the outreach clinics and were compared to 41 children in the hospital-affiliated clinic group. At ART initiation, median age, weight-for-age z-scores (WAZ and CD4(+ T-cell percentages were similar for children in the hospital-affiliated and outreach clinic groups. Children in both groups experienced similar increases in WAZ and CD4(+ T-cell percentages.HIV care and treatment can be effectively delivered to HIV-infected children at rural health centers through mobile ART teams, removing potential barriers to uptake and retention. Outreach teams should be supported to increase access to HIV care and treatment in rural areas.

  6. Evaluating the veterinary clinical teacher

    NARCIS (Netherlands)

    Boerboom, T.B.B.|info:eu-repo/dai/nl/322942489

    2011-01-01

    Introduction Providing clinical teachers with student feedback is an important part of faculty development. The current literature provides a range of instruments developed to generate student rating feedback. However, these instruments often lack a theoretical framework and evidence concerning

  7. 46, XX male: a case study of clinical, hormonal and molecular cytogenetic evaluation of sex development disorder

    International Nuclear Information System (INIS)

    Ali, S.; Shahid, S.M.; Azhar, A.

    2012-01-01

    Disorders of sex development (DSD) create medical and social dilemma. Maleness with XX genotype is a rare genetic condition affecting one in 24,000 new-born males. The XX male syndrome is a varied condition characterized by a spectrum of clinical presentation. ranging from normal male genitalia to ambiguous sex. Chromosomal anomalies are important cause of lack of development in secondary sexual characteristics, delayed puberty, miscarriage, infertility and other associated problems. An individual having ambiguous sex may have lifelong impact on social, psychological and sexual functions. The present case study describes the hormonal, clinical and molecular cytogenetics data of sex development disorders in a patient who was phenotypically male but cytogenetic analysis revealed 46.XX. (author)

  8. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue™): a European prospective multicentric feasibility study

    NARCIS (Netherlands)

    Doizi, Steeve; Kamphuis, Guido; Giusti, Guido; Andreassen, Kim Hovgaard; Knoll, Thomas; Osther, Palle Jörn; Scoffone, Cesare; Pérez-Fentes, Daniel; Proietti, Silvia; Wiseman, Oliver; de la Rosette, Jean; Traxer, Olivier

    2017-01-01

    We evaluated a new digital single-use flexible ureteroscope, LithoVue™ with respect to deflection, image quality and maneuverability. A prospective cohort study was conducted in eight tertiary reference centers in Europe in December 2015 and January 2016. All consecutive patients included underwent

  9. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART)

    Science.gov (United States)

    Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (L...

  10. A comparative evaluation of the efficacy of probiotic and chlorhexidine mouthrinses on clinical inflammatory parameters of gingivitis: A randomized controlled clinical study

    Directory of Open Access Journals (Sweden)

    Purnima Vidyesh Nadkerny

    2015-01-01

    Full Text Available Background: The aim of our clinical trial was to assess and compare the antiplaque and anti-inflammatory potential of a probiotic mouthwash with 0.2% chlorhexidine and saline. Materials and Methods: A randomized parallel group study was designed for a period of 4 weeks on 45 systemically healthy subjects between 20 and 30 years having chronic gingivitis. The study population was divided into three groups. Group A - 15 subjects were advised experimental (probiotic mouthwash. Group B - 15 subjects were advised positive control (chlorhexidine mouthwash and Group C - 15 subjects into a negative control group (normal saline. Oral prophylaxis was done for all groups at baseline. After the proper oral hygiene instructions, all the three groups were instructed to rinse their mouth with 10 ml of their respective mouthrinse, undiluted for 1 min twice daily, 30 min after brushing. Clinical parameters such as plaque index (PI, gingival index (GI, and oral hygiene index simplified (OHI-S were assessed at baseline, 2 weeks and 4 weeks, respectively. Results: At day 28, the PI, GI, and OHI-S were significantly reduced by all treatment modalities ranking probiotic and chlorhexidine is greater than saline. Conclusion: The probiotic mouthrinses tested was effectively used as an adjunct to mechanical plaque control in the prevention of plaque and gingivitis. Thus, the probiotic mouthrinse has a great therapeutic potential.

  11. Chronic diarrhea. Diagnosis and clinical evaluation

    International Nuclear Information System (INIS)

    Pineda O, Luis F; Otero R, William; Arbelaez M, Victor

    2004-01-01

    Chronic diarrhea is a syndrome of great clinical complexity, which is frequently encountered by general physicians, internists and gastroenterologists. Differential diagnosis is very broad and sometime finding the precise cause can be difficult, expensive and frustration. Literature published about this topic lack, in general, adequate controlled studies and for this reason recommendations for diagnostic evaluation and treatment are based upon series of cases, experience of the institutions or expert opinion and not on reasonable evidence. On the other hand, many of the classical diagnostic tests that have survived until now were designed over physiologic foundations and have not been validated extensively with the precision of a clinical test. This limits its acceptance, application and standardization in the daily practice. There is not a general agreement about diagnosis and treatment of chronic diarrhea and many of the experts divert recommendation about their recommendations. The purpose of this paper is to define some general guidelines about the clinical evaluation of patients with chronic diarrhea that lead us to a rational approach based upon clinical trials and the appropriate use of the many different tests

  12. Uncovering a clinical portrait of sluggish cognitive tempo within an evaluation for attention-deficit/hyperactivity disorder: A case study.

    Science.gov (United States)

    Becker, Stephen P; Ciesielski, Heather A; Rood, Jennifer E; Froehlich, Tanya E; Garner, Annie A; Tamm, Leanne; Epstein, Jeffery N

    2016-01-01

    Despite the burgeoning scientific literature examining the sluggish cognitive tempo (SCT) construct, very little is known about the clinical presentation of SCT. In clinical cases where SCT is suspected, it is critical to carefully assess not only for attention-deficit/hyperactivity disorder (ADHD) but also for other comorbidities that may account for the SCT-related behaviors, especially internalizing symptoms and sleep problems. The current case study provides a clinical description of SCT in a 7-year-old girl, offering a real-life portrait of SCT while also providing an opportunity to qualitatively differentiate between SCT and ADHD, other psychopathologies (e.g. depression, anxiety), and potentially related domains of functioning (e.g. sleep, executive functioning [EF]). "Jessica" was described by herself, parents, and teacher as being much slower than her peers in completing schoolwork, despite standardized testing showing Jessica to have above average intelligence and academic achievement. Jessica's parents completed rating scales indicating high levels of SCT symptoms and daytime sleepiness, as well as mildly elevated EF deficits. More research is needed to determine how to best conceptualize, assess, and treat SCT, and Jessica's case underscores the importance of further work in this area. © The Author(s) 2014.

  13. BALANOPOSTHITIS: A CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Raju

    2015-01-01

    Full Text Available INTRODUCTION: The inflammation of the non - keratinized epithelium of the glans penis (i.e., Balanities and that of prepuce (i.e., posthitis together comprise the term Balanoposthitis. AIMS AND OBJECTIVES: To determine the aetiological and p redisposing factors for the development of Balanoposthitis, and to know its relation with venereal and non - venereal disease, local and systemic precipitatin g factors. To know the prevalence of Balanoposthitis in STD clinic. Study design - retrospective study . MATERIALS AND METHODS: The study material consists of 75 cases of balanoposthitis attending out - patient department Skin & STD clinic during a period exten din g from Feb, 1998 to Feb, 1999 . CRITERIA FOR SELECTION OF A CASE: Only those cases which have a history of redness of glans or mucous surface of prepuce, with or without genital discharge or ulcer on glans or mucosal surface of prepuce with or without discharge or growth on the penis or fissuring of fore skin were selected for the study. RESULTS: Incidence of balanoposthitis during the period from Feb. 98 to Feb.99 was – 11.53%, out of 650 new STD cases. It was observed that maximum number of pat i ents w as in the 21 - 30 age group (33.34%. The next predominant groups affected were 17 - 20 & 31 - 40 age group (20% each. The third most common age group affected was 41 - 50 (16%. In this study 69 patients (92% who presented with balanoposthitis of whatever cause were found to be uncircumcised, only 6 cases (8% were found to be circumcised. Most cases who presented with balanoposthitis gave a history of exposure to STD risk. CONCLUSIONS: Balanoposthitis is very commonly encountered condition in the STD clinics wi th a multi factorial aetiology. Infective causes dominated over the other possible causes, and 30% of the candidial infection had diabetes mellitus as a predisposing factor.

  14. Residency evaluation and adherence design study: Young ophthalmologists' perception of their residency programs – Clinical and surgical skills

    Directory of Open Access Journals (Sweden)

    Parikshit Gogate

    2017-01-01

    Full Text Available Background: Residency training is the basis of good clinical and surgical practice. Purpose: The aim is to know the demographics, training experience, and perception of young ophthalmologists to improve the present residency programs in India. Setting: Young ophthalmologists trained in India. Methods: A survey was conducted by the Academic and Research Committee of the All India Ophthalmology Society, in 2014–2016 of young ophthalmologists (those trained between 2002 and 2012, with 2–10 years' postresidency experience to gauge teaching of clinical and surgical skills during the postgraduate residency program. Statistical Analysis: Statistical Package for Social Sciences version 16. Results: Of the 1005 respondents, 531 fulfilled inclusion criteria. Average age was 32.6 years (standard deviation [SD] 4. On a scale of 0–10, clinical skills teaching was graded as (mean, SD: Slit lamp examination (7.2, SD 2.8, indirect ophthalmoscopy (6.2, SD 3.3, gonioscopy (5.7, SD 3.4, perimetry (6.2, SD 3.2, optical coherence tomography (4.6, SD 4, and orthoptic evaluation (4.3, SD 3.1. The mean (SD and median of surgeries performed independently was intracapsular cataract extraction 3.0 (14.9, 0; extracapsular cataract extraction 39.9 (53.2, 18; small incision cataract surgery 75.3 (64.4, 55; phacoemulsification 30 (52.6, 1; pterygium excision 31.5 (43.5, 15; dacryocystectomy 20.3 (38.1, 4; dacryocystorhinostomy 11.7 (26.2, 2; chalazion 46.4 (48.3, 30; trabeculectomies 4 (14.9, 0; strabismus correction 1.4 (4.9, 0; laser-assisted in situ Keratomileusis 1.5 (12.2, 0; retinal detachment 1.5 (12.5, 0; vitrectomy 3.0 (17.0, 0; keratoplasty 5.2 (17.8, 0; eyelid surgery 8.6 (18.9, 2 and ocular emergencies 41.7 (52.4, 20. Observed and assisted surgeries were more common. However, the range of grading was 0–10 in all categories. Conclusion: Residency training in India varies considerably from program to program. Standardization is needed to assure all graduates

  15. Clinical evaluation of chitotriosidase enzyme activity in Gaucher and Niemann Pick A/B diseases: A retrospective study from India.

    Science.gov (United States)

    Kadali, Srilatha; Kolusu, Anusha; Sunkara, Satish; Gummadi, Maheshwar Reddy; Undamatla, Jayanthi

    2016-06-01

    Plasma chitotriosidase originates from activated macrophages and is reported to be elevated in many Lysosomal Storage Disorders. Measurement of this enzyme activity has been an available tool for monitoring therapy of Gaucher disease. The degree of elevation of chitotriosidase is useful for differential diagnosis of Gaucher disease and Niemann Pick A/B. However the potential utility of this chitotriosidase assay depends on the frequency of deficient chitotriosidase activity in a particular population. We therefore aim to study the clinical utility of this assay Gaucher and Niemann Pick A/B diseases in the backdrop of chitotriosidase deficiency in our population. The study comprises 173 patients with clinical suspicion of either Gaucher disease (n=108) or Niemann Pick A/B (n=65) and 92 healthy controls. The plasma samples of controls, Gaucher disease, and Niemann Pick A/B showed chitotriosidase deficiency of 12%, 25% and 27% respectively. The degree of elevation of chitotriosidase in Gaucher disease and Niemann Pick A/B patients is 40-326 (11,325.7±6395.4nmol/h/ml) and 7-22 folds (1192.5±463.0nmol/h/ml) respectively. In view of these findings of distinguishable fold elevation of chitotriosidase in Gaucher disease or Niemann Pick A/B, it can be a potential surrogate differential diagnostic marker for these groups of diseases, except in the patients in whom this enzyme is deficient. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Pooled analysis of menstrual irregularities from three major clinical studies evaluating everolimus for the treatment of tuberous sclerosis complex.

    Directory of Open Access Journals (Sweden)

    Steven Sparagana

    Full Text Available To determine the impact of everolimus on female fertility, including menstrual irregularities, secondary amenorrhea, and luteinizing and follicle stimulating hormone levels in female patients.A pooled analysis from 3 prospective studies consisting of a core phase (≥6 months and a long-term follow-up open-label extension.One phase 2 single-center and two phase 3 multicenter studies.Data were obtained from female participants, restricted to those between 10 and 55 years of age, during 1 of 3 of the described clinical trials of everolimus. Patients had received ≥ 1 dose of everolimus.Incidence of fertility events.A total of 43/112 patients (38.4% experienced at least 1 menstrual irregularity. The most common events were amenorrhea (24.1% and irregular menstruation (17.0%. Seven patients (6.3% experienced grade 3/4 amenorrhea. When only the longest duration period of amenorrhea for each patient was considered, the median duration was 291 days. Fifteen patients attained menarche during the treatment period in any of the pooled studies. The mean age of menarche for this group was 12.4 years, similar to that of patients who were postmenarche at study entry (12.2 years. A total of 19/92 patients (20.7% who were postmenarche at baseline or during the study experienced an irregular menstruation event. An increased luteinizing hormone level was reported as an adverse event in 3/112 patients (3%, and follicle-stimulating hormone levels were within normal limits for these patients.No new safety concerns emerged regarding endocrine function and menstruation in female patients with tuberous sclerosis complex-associated subependymal giant cell astrocytoma or angiomyolipoma, who were receiving everolimus.ClinicalTrials.gov NCT00411619, NCT00789828, NCT00790400.

  17. Power Doppler Ultrasound Evaluation of Peripheral Joint, Entheses, Tendon, and Bursa Abnormalities in Psoriatic Patients: A Clinical Study.

    Science.gov (United States)

    Tang, Yuanjiao; Yang, Yujia; Xiang, Xi; Wang, Liyun; Zhang, Lingyan; Qiu, Li

    2018-04-15

    To evaluate the prevalence rates of peripheral joint, enthesis, tendon, and bursa abnormalities by power Doppler (PD) ultrasonic examination in patients with psoriatic arthritis (PsA), psoriatic patients without clinical signs of arthritis (non-PsA psoriasis group), and healthy individuals, to detect subclinical PsA. A total of 253 healthy volunteers, 242 non-PsA psoriatic patients, and 86 patients with PsA were assessed by 2-dimensional and power Doppler (PD) ultrasound. Peripheral joint, enthesis, tendon, and bursa abnormalities were observed, characterizing abnormal PD. The affected patients and sites with abnormalities in various ages were compared among groups; PD signal grades for the abnormalities were also compared. In the PsA group, significantly higher percentages of sites showing joint effusion/synovitis, enthesitis, and tenosynovitis in all age groups, and markedly higher rates of sites with bursitis were found in young and middle age groups, compared with the non-PsA and control groups (all p the non-PsA group showed significantly higher rates of joint effusion/synovitis and enthesitis sites, and elevated PD signal grades of synovitis, enthesitis, and tenosynovitis in comparison with the control group, both in young and middle age groups (all p tenosynovitis.

  18. Evaluating critical thinking in clinical practice.

    Science.gov (United States)

    Oermann, M H

    1997-01-01

    Although much has been written about measurement instruments for evaluating critical thinking in nursing, this article describes clinical evaluation strategies for critical thinking. Five methods are discussed: 1) observation of students in practice; 2) questions for critical thinking, including Socratic questioning; 3) conferences; 4) problem-solving strategies; and 5) written assignments. These methods provide a means of evaluating students' critical thinking within the context of clinical practice.

  19. Clinical evaluation in periodontitis patient after curettage

    Directory of Open Access Journals (Sweden)

    Widowati Witjaksono

    2006-09-01

    Full Text Available Curettage is used in periodontics to scrap off the gingival wall of a periodontal pocket, and is needed to reduce loss of attachment (LOA by developing new connective tissue attachment in patients with periodontitis. The purpose of this study was to evaluate the success of curettage by the formation of tissue attachment. This clinical experiment was done by comparing LOA before curettage, 2 weeks and 3 weeks after curettage on 30 teeth with the indication of curettage. Study population were periodontitis patient who attending dental clinic at Hospital University Science Malaysia (HUSM with inclusion criteria good general health condition, 18 to 55 years old male or female and presented with pocket depth > 3mm. The teeth were thoroughly scaling before intervention and evaluated by measuring the periodontal attachment before curettage, two weeks and three weeks after curettage. Repeated measure ANOVA and Paired T Test were used to analyze the data. The result of the study showed that there was reduction in the periodontal attachment loss in periodontitis patient after curettage either in the anterior or posterior teeth which were supported by statistical analysis. This study concluded that curettage could make reattachment of the tissue

  20. A phase I clinical study to evaluate safety of orally administered, genetically engineered Salmonella enterica serovar Typhimurium for canine osteosarcoma

    OpenAIRE

    Fritz, Sara; Henson, Michael; Greengard, Emily; Winter, Amber; Stuebner, Kathleen; Yoon, Una; Wilk, Vicki; Borgatti, Antonella; Augustin, Lance; Modiano, Jaime; Saltzman, Daniel

    2017-01-01

    Abstract We conducted a prospective phase I study to evaluate safety of an orally administered Salmonella encoding IL‐2 (SalpIL2) in combination with amputation and adjuvant doxorubicin for canine appendicular osteosarcoma. Efficacy was assessed as a secondary measure. The first dose of SalpIL2 was administered to 19 dogs on Day 0; amputation was done after 10 days with chemotherapy following 2 weeks later. SalpIL2 was administered concurrent with chemotherapy, for a total of five doses of do...

  1. Clinical evaluation of dengue and identification of risk factors for severe disease: protocol for a multicentre study in 8 countries

    OpenAIRE

    Jaenisch, Thomas; Tam, Dong Thi Hoai; Kieu, Nguyen Tan Thanh; Van Ngoc, Tran; Nam, Nguyen Tran; Van Kinh, Nguyen; Yacoub, Sophie; Chanpheaktra, Ngoun; Kumar, Varun; See, Lucy Lum Chai; Sathar, Jameela; Sandoval, Ernesto Pleit?s; Alfaro, Gabriela Maria Mar?n; Laksono, Ida Safitri; Mahendradhata, Yodi

    2016-01-01

    Background: The burden of dengue continues to increase globally, with an estimated 100 million clinically apparent infections occurring each year. Although most dengue infections are asymptomatic, patients can present with a wide spectrum of clinical symptoms ranging from mild febrile illness through to severe manifestations of bleeding, organ impairment, and hypovolaemic shock due to a systemic vascular leak syndrome. Clinical diagnosis of dengue and identification of which patients are like...

  2. Evaluation of SMN protein, transcript, and copy number in the biomarkers for spinal muscular atrophy (BforSMA clinical study.

    Directory of Open Access Journals (Sweden)

    Thomas O Crawford

    Full Text Available The universal presence of a gene (SMN2 nearly identical to the mutated SMN1 gene responsible for Spinal Muscular Atrophy (SMA has proved an enticing incentive to therapeutics development. Early disappointments from putative SMN-enhancing agent clinical trials have increased interest in improving the assessment of SMN expression in blood as an early "biomarker" of treatment effect.A cross-sectional, single visit, multi-center design assessed SMN transcript and protein in 108 SMA and 22 age and gender-matched healthy control subjects, while motor function was assessed by the Modified Hammersmith Functional Motor Scale (MHFMS. Enrollment selectively targeted a broad range of SMA subjects that would permit maximum power to distinguish the relative influence of SMN2 copy number, SMA type, present motor function, and age.SMN2 copy number and levels of full-length SMN2 transcripts correlated with SMA type, and like SMN protein levels, were lower in SMA subjects compared to controls. No measure of SMN expression correlated strongly with MHFMS. A key finding is that SMN2 copy number, levels of transcript and protein showed no correlation with each other.This is a prospective study that uses the most advanced techniques of SMN transcript and protein measurement in a large selectively-recruited cohort of individuals with SMA. There is a relationship between measures of SMN expression in blood and SMA type, but not a strong correlation to motor function as measured by the MHFMS. Low SMN transcript and protein levels in the SMA subjects relative to controls suggest that these measures of SMN in accessible tissues may be amenable to an "early look" for target engagement in clinical trials of putative SMN-enhancing agents. Full length SMN transcript abundance may provide insight into the molecular mechanism of phenotypic variation as a function of SMN2 copy number.Clinicaltrials.gov NCT00756821.

  3. Reflective journaling for clinical judgment development and evaluation.

    Science.gov (United States)

    Lasater, Kathie; Nielsen, Ann

    2009-01-01

    Reflective journaling is a strategy used often in clinical education to gain insight into students' clinical thinking; however, studies indicate that students may benefit from guided reflections. Numerous tools have been used to structure student reflection with varying results. This article describes the outcomes from using the Guide for Reflection based on Tanner's Clinical Judgment Model. The Lasater Clinical Judgment Rubric, created from the Model, is used to evaluate development of clinical judgment and provides language to communicate about clinical thinking with students. Senior immersion course competencies, also developed with language from Tanner's Clinical Judgment Model,offer a comprehensive package that fosters students' clinical judgment development, faculty-student communication about clinical judgment, and evaluation of students' clinical thinking.

  4. Evaluation of the Effectiveness of Postgraduate General Medicine Training by Objective Structured Clinical Examination—Pilot Study and Reflection on the Experiences of Kaohsiung Medical University Hospital

    Directory of Open Access Journals (Sweden)

    Jer-Chia Tsai

    2008-12-01

    Full Text Available Objective structured clinical examination (OSCE is an effective assessment method to evaluate medical students' clinical competencies performance. Postgraduate year 1 (PGY1 residents have been initiated in a general medicine training program in Taiwan since 2003. However, little is known about the learning effectiveness of trainees from this program. This pilot study aimed to evaluate the clinical core competencies of PGY1 residents using OSCE, and to reflect on the strengths and weaknesses of this pilot assessment project. OSCE was conducted for five PGY1 examinees (4 men, 1 woman with five stations covering core themes, including history taking, physical examination, clinical procedure of airway intubation, clinical reasoning, and communication skills for informing bad news. Itemized checklists and five-point Likert scale global ratings were used for evaluating performance. The results showed that the performance of our PGY1 residents on history taking was significantly better after about 2 months of postgraduate training on general internal medicine. Self-evaluation on performance by examinees revealed significantly lower global ratings on post-course OSCE (4.14 ± 0.80 vs. 3.68 ± 0.66; p < 0.02. Surveys from tutors and standardized patients (SPs completed at pre- and post-course OSCEs showed consistently favorable responses on the purposes, content, process, and environment of this assessment (4.0 ± 0.17 vs. 4.0 ± 0.12, nonsignificant. However, a survey of the examinees completed at preand post-course OSCEs showed relatively unfavorable responses to the same aspects, and to tutors and SPs (4.1 ± 0.09 vs. 3.7 ± 0.18; p < 0.05. Qualitative information revealed that tutors and SPs remarked that PGY1 residents' medical knowledge performance was satisfactory but their clinical reasoning performance, communication skills (giving bad news and self-confidence were unsatisfactory. In conclusion, this pilot study has demonstrated that OSCE is a

  5. A comparative evaluation of 4% articaine and 2% lidocaine in mandibular buccal infiltration anesthesia: A clinical study

    Science.gov (United States)

    Maruthingal, Sunith; Mohan, Dennis; Maroli, Ramesh Kumar; Alahmari, Ali; Alqahtani, Ahmed; Alsadoon, Mohammed

    2015-01-01

    Background: To compare 4% articaine and 2% lidocaine local anesthetics in achieving pulpal anesthesia of the lower first permanent molar teeth objectively, and to assess and compare lip and lingual mucosa numbness subjectively. Materials and Methods: All subjects received 1.7 ml of any one anesthetic in the mucobuccal fold adjacent to mandibular first molar teeth; the same individuals received the second infiltration at least 1 week after the first. Later, comparisons for pulpal anesthesia, lip and lingual mucosa numbness between these two anesthetics solutions were made. Results: Articaine showed significant results with P = 0.006 in achieving pulpal anesthesia objectively, when compared with lidocaine. Articaine also showed very high significant results subjectively with P = 0.0006 in achieving lip numbness, when compared with lidocaine. But the results in achieving lingual mucosa numbness with articaine subjectively was not significant with P = 0.01, when compared with lidocaine. Conclusion: Endodontic and operative treatments are one of the most common oral non-surgical procedures done under local anesthesia. The diversity of anesthetic substances currently available on the market requires dental professionals to assess the drug both by its pharmacokinetic and also by its clinical characteristics during dental treatments. Our study used 4% articaine, which is available in the market, for comparison with 2% lidocaine. Further studies are required to use an equal concentration of solutions to achieve more accurate results. PMID:26759799

  6. A pilot study to evaluate the clinical relevance of endometriosis-associated nerve fibers in peritoneal endometriotic lesions.

    Science.gov (United States)

    Mechsner, Sylvia; Kaiser, Andrea; Kopf, Andreas; Gericke, Christine; Ebert, Andreas; Bartley, Julia

    2009-12-01

    To investigate the clinical relevance of endometriosis-associated nerve fibers in the development of endometriosis-associated symptoms. Prospective nonrandomized study. University hospital endometriosis center. Fifty-one premenopausal patients underwent surgical laparoscopy because of chronic pelvic pain, dysmenorrhea, or for ovarian cysts. Endometriosis was diagnosed in 44 patients. The preoperative and postoperative pain scores were determined using a standardized questionnaire with a visual analogue scale from 1-10. Patients with peritoneal endometriosis were divided into two groups depending on their preoperative pain score: group A with a pain score of at least 3 or more and group B with a pain score of 2 or less. Patients without peritoneal endometriosis were classified as group C and patients without endometriosis were classified as group D. Immunohistochemical analysis of neurofilament and protein gene product 9.5 were used for nerve fiber detection. Occurrence of endometriosis-associated nerve fibers was correlated with the severity of pelvic pain and/or dysmenorrhea. Peritoneal endometriosis-associated nerve fibers were found significantly more frequently in group A than in group B (82.6% vs. 33.3%). The present study suggests that the presence of endometriosis-associated nerve fibers in the peritoneum is important for the development of endometriosis-associated pelvic pain and dysmenorrhea.

  7. Clinical evaluation of dengue and identification of risk factors for severe disease : protocol for a multicentre study in 8 countries

    NARCIS (Netherlands)

    Jaenisch, Thomas; Dong Thi Hoai Tam,; Nguyen Tan Thanh Kieu,; Tran Van Ngoc,; Nguyen Tran Nam,; Nguyen Van Kinh,; Yacoub, Sophie; Chanpheaktra, Ngoun; Kumar, Varun; See, Lucy Lum Chai; Sathar, Jameela; Sandoval, Ernesto Pleites; Maron Alfaro, Gabriela Maria; Laksono, Ida Safitri; Mahendradhata, Yodi; Sarker, Malabika; Ahmed, Firoz; Caprara, Andrea; Benevides, Bruno Souza; Marques, Ernesto T. A.; Magalhaes, Tereza; Brasil, Patricia; Netto, Marco; Tami, Adriana; Bethencourt, Sarah E.; Guzman, Maria; Simmons, Cameron; Nguyen Thanh Ha Quyen,; Merson, Laura; Nguyen Thi Phuong Dung,; Beck, Dorothea; Wirths, Marius; Wolbers, Marcel; Phung Khanh Lam,; Rosenberger, Kerstin; Wills, Bridget

    2016-01-01

    BACKGROUND: The burden of dengue continues to increase globally, with an estimated 100 million clinically apparent infections occurring each year. Although most dengue infections are asymptomatic, patients can present with a wide spectrum of clinical symptoms ranging from mild febrile illness

  8. A clinical study to evaluate the correlation between maxillary central incisor tooth form and face form in an Indian population.

    Science.gov (United States)

    Koralakunte, Pavankumar R; Budihal, Dhanyakumar H

    2012-09-01

    A study was performed to examine the correlation between maxillary central incisor tooth form and face form in males and females in an Indian population. The selection of prosthetic teeth for edentulous patients is a primary issue in denture esthetics, especially in the case of maxillary central incisors, which are the most prominent teeth in the arch. Two hundred dental students of Indian origin comprising 79 males and 121 females aged 18-28 years studying at Bapuji Dental College and Hospital were randomly selected as the study subjects. A standardized photographic procedure was used to obtain images of the face and the maxillary central incisors. The outline forms of the face and the maxillary right central incisor tooth were determined using a standardized method. The outline forms obtained were used to classify both face form and tooth form on the basis of visual and William's methods. The means were considered after evaluation by five prosthodontists, and the results were tabulated. Statistical analysis was performed using the chi-squared test for association and Z-test for equality of proportions. A correlation greater than 50% was observed between tooth form and face form by the visual method, compared with one of 31.5% by William's method. There was no highly defined correlation between maxillary central incisor tooth form and face form among the male and female Indian subjects studied.

  9. Comparative evaluation of subgingival plaque microflora in pregnant and non-pregnant women: A clinical and microbiologic study

    Directory of Open Access Journals (Sweden)

    Rishi Emmatty

    2013-01-01

    Full Text Available Context: Gingival changes in pregnancy have been attributed to changes in the subgingival biofilm related to hormonal variations. Aims: To evaluate the subgingival plaque microflora in pregnant and nonpregnant women to determine if pregnancy induces any alterations in the subgingival plaque and to associate these changes with changes in periodontal status. Settings and Design: Thirty pregnant and 10 nonpregnant women within the age group of 20-35 years having a probing pocket depth (PPD of 3-4 mm were included in the study. The pregnant women were equally divided into 3 groups of 10, each belonging to I, II, and III trimester. Materials and Methods: Plaque index, gingival index, PPD, and microbiologic evaluation for specific bacterial counts for Prevotella intermedia, Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans, Parvimonas micra, and Fusobacterium nucleatum were carried out for all subjects. Statistical Analysis: Mann-Whitney U test. Results: Increase in gingival inflammation was observed in II and III trimester as compared with I trimester and control. Plaque scores did not show any significant difference between pregnant and nonpregnant women. Specific bacterial examination revealed an increase in proportion of P. intermedia in pregnant women of both II and III trimester as compared with I trimester and nonpregnant women. Conclusions: A definite increase in proportions of P. intermedia occurs in subgingival plaque microflora in pregnancy that may be responsible for the exaggerated gingival response.

  10. Study, development and clinical evaluation of a per-operative {gamma} imager; Etude, developpement et evaluation clinique d`un imageur {gamma} per-operatoire

    Energy Technology Data Exchange (ETDEWEB)

    Menard, Laurent [Inst. de Physique Nucleaire, Paris-11 Univ., 91 - Orsay (France)

    1999-01-19

    The precise localization and complete surgical ablation of tumors are one of the most important procedures in cancer treatment. In that context, the use, in operating room, of light hand-held detectors associated to radiopharmaceutical compounds for tumor labelling, plays a significant role in assisting surgeons in real-time detection of lesion. The POCI gamma imaging probe (Per-Operative Compact Imager), which is presented here, is precisely dedicated to improve the radio-guided operative cancer surgery efficiency by bringing a new tool discriminating between healthy and pathological tissues. To match the specifications of intra-operative detection, we chose to build our camera around an intensified position sensitive diode which appeared to be particularly suitable to achieve a high resolution small size imager. The optimal geometry of two gamma detection head modules, composed of parallel hole collimators and scintillation crystals, was then investigated by numerical simulations. From these technological solutions, a first prototype of POCI with a 24 mm diameter field of view has been developed. Its characterization has put forward a millimeter spatial resolution and a detection efficiency comparable to that of clinical gamma cameras and in agreement with the numerical predictions. Finally, in collaboration with Gustave Roussy, a first clinical evaluation of the POCI camera has been performed for sentinel ganglion pre-operative localization in patients afflicted by malignant melanomas or breast cancers. The preliminary results have already shown that the performances of POCI are compatible with intraoperative imaging purposes and suggest how this camera can boost the success rate of tumor removal surgeries for other cancerous diseases. (author) 100 refs., 67 figs., 11 tabs.

  11. Subjective vs. objective evaluation of gallbladder opacification during oral cholecystography in comparative clinical trials: implications for studies involving visual assessment

    International Nuclear Information System (INIS)

    Fon, G.T.; Hunter, T.B.; Berk, R.N.; Patton, D.D.; Capp, M.P.

    1982-01-01

    Radiographs and CT images taken during oral cholecystography in dogs were interpreted in an independent, blind fashion by three radiologists on two occasions and visual assessment of gallbladder density compared to the actual CT values. While there was significant intra- and inter-observer variation, the mean scores for the observers' interpretations of both radiographs and prints correlated well with the actual CT values (p > 0.05). In five out of six comparisons between first and second readings, the observers gave a lower score on the second reading. The considerable variation reflects the problems inherent in subjective evaluation of agents that produce small but measurable differences in radiographic density. Studies involving such subjective data have to be carefully designed in order to obtain meaningful results

  12. Evaluation Apprehension and Impression Management in Clinical Medical Education.

    Science.gov (United States)

    McGaghie, William C

    2018-05-01

    Historically, clinical medical education has relied on subjective evaluations of students and residents to judge their clinical competence. The uncertainty associated with these subjective clinical evaluations has produced evaluation apprehension among learners and attempts to manage one's professional persona (impression management) among peers and supervisors. Such behavior has been documented from antiquity through the Middle Ages to the present, including in two new qualitative studies in this issue of Academic Medicine on the social psychology of clinical medical education. New approaches to medical education, including competency-based education, mastery learning, and assessment methods that unite evaluation and education, are slowly changing the culture of clinical medical education. The author of this Invited Commentary argues that this shift will bring greater transparency and accountability to clinical medical education and gradually reduce evaluation apprehension and the impression management motives it produces.

  13. ABDOMINAL TRAUMA- CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Vanaja Ratnakumari Billa

    2017-08-01

    Full Text Available BACKGROUND In the recent times there has been increased incidence of abdominal trauma cases due to several causes. Quick and prompt intervention is needed to decrease the mortality of the patients. So we conducted a study to assess the cause and the management of abdominal trauma cases in our institution. The aim of this study was to know the incidence of blunt and penetrating injuries and their causes, age and sex incidence, importance of various investigations, mode of treatment offered and post-operative complications. To study the cause of death and evolve better management. MATERIALS AND METHODS The present study comprises of patients admitted to and operated in various surgical units in the Department of Surgery at Government General Hospital, attached to Guntur Medical College Guntur, from August 2014 to October 2016. RESULTS Increase incidence seen in age group 20-29 years (30%. Male predominance 77.5%. Mechanism of injury–road traffic accidents 65%. Isolated organ injury–colon and rectum 40%. Other associated injuries–chest injuries with rib fractures 7.5%. Complications–wound infection 17.5%. Duration of hospital stay 8–14 days. Bowel injury management–closure of perforation 84.6%. Resection anastomosis 15.38%. CONCLUSION Thorough clinical examination, diagnostic paracentesis, plain X-ray erect abdomen and ultrasound proved to be very helpful in the diagnosis of intra-abdominal injuries. Spleen is the commonest organ involved in blunt trauma and colon is the commonly injured organ in penetrating abdominal trauma, many patients have associated extremity and axial skeleton injuries. With advances in diagnosis and intensive care technologies, most patients of solid visceral injuries with hemodynamic stability can be managed conservatively. Surgical site infection is the most common complication following surgery. The mortality is high; reason might be patient reaching the hospital late, high incidence of postoperative septic

  14. Clinical education and clinical evaluation of respiratory therapy students.

    Science.gov (United States)

    Cullen, Deborah L

    2005-09-01

    Different blends of knowledge, decision making, problem solving,professional behaviors, values, and technical skills are necessary in the changing health care environments in which respiratory therapists practice. Frequently, novice students are expected to perform quickly and efficiently,and it may be forgotten that students are still learning and mastering the foundation pieces of practice. Clinical educators take on the responsibility of student development in addition to overseeing patient care. Normally,these volunteer instructors are role models for respiratory therapy students. The characteristic of initiative when demonstrated by a beginning student is attractive to the clinical instructor, promotes sharing of experiences, and may evolve into a mentor-protege relationship. Some clinical instructors may be underprepared to teach and are uncomfortable with student evaluation. Respiratory therapy facilities in conjunction with academic institutions may consider sponsoring ongoing programs for clinical teachers. Teaching and learning in the clinical environment is more than demonstration of skills and knowledge. Furthermore, it can be debated whether the memorization of facts or of the steps of a skill is more valuable than competency in problem solving, clinical reasoning, or information retrieval. New knowledge is built within a context and is further integrated when grounded by experience. Development of "prediction in practice" or the anticipation of the next necessary actions may be worth integrating into the instructional toolbox. Intuition has been defined as an "understanding without a rationale". This definition separates intuition from rational decision making and presents intuition as a type of innate ability. Reflection when guided by clinical instructors can help deepen critical thinking, as will Socratic questioning on a regular basis. Most clinical staff can agree on the performance of an incompetent student, but discrimination of the levels of

  15. Evaluation of a controlled, national collaboration study on a clinical pharmacy service of screening for risk medications

    DEFF Research Database (Denmark)

    Kjeldsen, Lene Juel; Clemmensen, Marianne Hald; Kronborg, Christian

    2014-01-01

    . Inpatients were screened for the use of five risk medications; anticoagulants, digoxin, methotrexate, NSAIDs and opioids, and during the intervention period recommendations were made by clinical pharmacists according to a standardized intervention scheme. The recommendations were discussed with the physician...

  16. Uncertainty sources in radiopharmaceuticals clinical studies

    International Nuclear Information System (INIS)

    Degenhardt, Aemilie Louize; Oliveira, Silvia Maria Velasques de

    2014-01-01

    The radiopharmaceuticals should be approved for consumption by evaluating their quality, safety and efficacy. Clinical studies are designed to verify the pharmacodynamics, pharmacological and clinical effects in humans and are required for assuring safety and efficacy. The Bayesian analysis has been used for clinical studies effectiveness evaluation. This work aims to identify uncertainties associated with the process of production of the radionuclide and radiopharmaceutical labelling as well as the radiopharmaceutical administration and scintigraphy images acquisition and processing. For the development of clinical studies in the country, the metrological chain shall assure the traceability of the surveys performed in all phases. (author)

  17. Electronic portal imaging device detection of radioopaque markers for the evaluation of prostate position during megavoltage irradiation: a clinical study

    International Nuclear Information System (INIS)

    Vigneault, Eric; Pouliot, Jean; Laverdiere, Jacques; Roy, Jean; Dorion, Marc

    1997-01-01

    Purpose: This study was designed to assess daily prostatic apex motion relative to pelvic bone structures during megavoltage irradiation. Methods and Materials: Radioopaque markers were implanted under ultrasound guidance near the prostatic apex of 11 patients with localized prostatic carcinoma. Patients were subsequently treated with a four field-box technique at a beam energy of 23 MV. During treatment, on-line images were obtained with an electronic portal imaging device (EPID). The marker was easily identified, even on unprocessed images, and the distance between the marker and a bony landmark was measured. Timelapse movies were also reviewed. After the completion of treatment, a transcrectal ultrasound examination was performed in 8 of 11 patients, to verify the position of the marker. Results: We acquired over 900 digital portal images and analyzed posterioanterior and right lateral views. The quality of portal images obtained with megavoltage irradiation was good. It was possible to evaluate pelvic bone structures even without image histogram equalization. Moreover, the radioopaque marker was easily visible on every online portal image. The review of timelapse movies showed important interfraction motion of the marker while bone structures remained stable. We measured the position of the marker for each fraction. Marker displacements up to 1.6 cm were measured between 2 consecutive days of treatment. Important marker motions were predominantly in the posteroanterior and cephalocaudal directions. In eight patients, we verified the position of the marker relative to the prostatic apex with ultrasound at the end of the treatments. The marker remained in the trapezoid zone. Intratreatment images reviewed in two cases showed no change in marker position. Our results, obtained during the treatment courses, indicate similar or larger prostate motions than previously observed in studies that used intertreatment x-ray films and CT images. Marker implantation under

  18. CO2 and diode laser for excisional biopsies of oral mucosal lesions. A pilot study evaluating clinical and histopathological parameters.

    Science.gov (United States)

    Suter, Valérie G A; Altermatt, Hans Jörg; Sendi, Pedram; Mettraux, Gérald; Bornstein, Michael M

    2010-01-01

    The present pilot study evaluates the histopathological characteristics and suitability of CO2 and diode lasers for performing excisional biopsies in the buccal mucosa with special emphasis on the extent of the thermal damage zone created. 15 patients agreed to undergo surgical removal of their fibrous hyperplasias with a laser. These patients were randomly assigned to one diode or two CO2 laser groups. The CO2 laser was used in a continuous wave mode (cw) with a power of 5 W (Watts), and in a pulsed char-free mode (cf). Power settings for the diode laser were 5.12 W in a pulsed mode. The thermal damage zone of the three lasers and intraoperative and postoperative complications were assessed and compared. The collateral thermal damage zone on the borders of the excisional biopsies was significantly smaller with the CO, laser for both settings tested compared to the diode laser regarding values in pm or histopathological index scores. The only intraoperative complication encountered was bleeding, which had to be controlled with electrocauterization. No postoperative complications occurred in any of the three groups. The CO2 laser seems to be appropriate for excisional biopsies of benign oral mucosal lesions. The CO2 laser offers clear advantages in terms of smaller thermal damage zones over the diode laser. More study participants are needed to demonstrate potential differences between the two different CO2 laser settings tested.

  19. An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness.

    Science.gov (United States)

    Barlow, Jane; Sembi, Sukhdev; Gardner, Frances; Macdonald, Geraldine; Petrou, Stavros; Parsons, Helen; Harnett, Paul; Dawe, Sharon

    2013-07-11

    Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant's physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents.An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent-infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby's development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems. The study comprises a multicentre randomised controlled trial using a mixed-methods approach to data collection and analysis in order to identify which families are most able to benefit from this intervention.The study is being conducted in six family centres across the UK, and targets primary caregivers of children less than 2.5 years of age who are substance dependent. Consenting participants are randomly allocated to either the 20-week PuP programme or to standard care.The primary outcome is child abuse potential, and secondary outcomes include substance use, parental mental health and emotional regulation, parenting stress, and infant/toddler socio

  20. EPID detection of radio-opaque markers for the evaluation of prostate position during megavoltage irradiation: a clinical study

    International Nuclear Information System (INIS)

    Vigneault, E.; Pouliot, J.; Laverdiere, J.; Roy, J.

    1995-01-01

    than previous published data using intertreatment X-ray films and CT images. Marker implantation under transrectal ultrasound was well tolerated. Patients presented no fever or urogenital infection. Conclusions: Radio-opaque marker in combination with electronic portal imaging give a direct evaluation of prostatic motion during radiation treatment. As shown in previous studies, prostatic motion is independent of the bony structures. The motions observed are predominantly in the antero-posterior and cephalo-caudal directions. Prostate motion during treatment is important and must be considered especially when using conformal therapy

  1. Near-real time oculodynamic MRI: a feasibility study for evaluation of diplopia in comparison with clinical testing

    Energy Technology Data Exchange (ETDEWEB)

    Berg, Isabelle; Schwenzer-Zimmerer, Katja; Zeilhofer, Hans-Florian; Kunz, Christoph [University Hospital Basel, Hightech Research Center of Cranio-Maxillofacial Surgery and Dept. of Cranio-Maxillofacial Surgery, Basel (Switzerland); Palmowski-Wolfe, Anja [University of Basel, Department of Ophthalmology, Basel (Switzerland); Kober, Cornelia [HAW Hamburg, Faculty of Life Sciences, Hamburg (Germany); Radue, Ernst-Wilhelm [University Hospital Basel, Department of Neuroradiology, Basel (Switzerland); Scheffler, Klaus [University Hospital Basel, Division of Radiological Physics, Basel (Switzerland); Buitrago-Tellez, Carlos [Hightech Research Center of Cranio-Maxillofacial Surgery, Spital Zofingen AG, Institute of Radiology, Zofingen (Switzerland); University Hospital Basel, Zofingen (Switzerland)

    2012-02-15

    To demonstrate feasibility of near-real-time oculodynamic magnetic resonance imaging (od-MRI) in depicting extraocular muscles and correlate quantitatively the motion degree in comparison with clinical testing in patients with diplopia. In 30 od-MRIs eye movements were tracked in the horizontal and sagittal plane using a a TrueFISP sequence with high temporal resolution. Three physicians graded the visibility of extraocular muscles by a qualitative scale. In 12 cases, the maximal monocular excursions in the horizontal and vertical direction of both eyes were measured in od-MRIs and a clinical test and correlated by the Pearson test. The medial and lateral rectus muscles were visible in the axial plane in 93% of the cases. The oblique, superior and inferior rectus muscles were overall only in 14% visible. Horizontal (p = 0,015) and vertical (p = 0,029) movements of the right eye and vertical movement of the left eye (p = 0,026) measured by od-MRI correlated positively to the clinical measurements. Od-MRI is a feasible technique. Visualization of the horizontal/vertical rectus muscles is better than for the superior/inferior oblique muscle. Od-MRI correlates well with clinical testing and may reproduce the extent of eye bulb motility and extraocular muscle structural or functional deteriorations. (orig.)

  2. Psychosexual development in adolescents and adults with disorders of sex development--results from the German Clinical Evaluation Study.

    Science.gov (United States)

    Jürgensen, Martina; Kleinemeier, Eva; Lux, Anke; Steensma, Thomas D; Cohen-Kettenis, Peggy T; Hiort, Olaf; Thyen, Ute; Köhler, Birgit

    2013-11-01

    Both biological and psychosocial factors influence psychosexual development. High levels of pre- and postnatal androgens lead to more male-typical behavior. So far, the influence of androgens on gender identity and sexual orientation is unclear. Disorders of sex development (DSDs) are heterogeneous genetic conditions with different levels of prenatal androgens resulting in variations of genital development. Through DSD, the role of the different factors, especially androgen exposure, on psychosexual development can be evaluated. The purpose of the study was to assess psychosexual development in adolescents and adults with different forms of DSD. For the examination of psychosexual development of 66 adolescents and 110 adults with DSD, the authors used the Utrecht Gender Dysphoria Scale for adolescents, the Questionnaire of Gender Identity for adults, and a condition-specific DSD study questionnaire. Individuals were analyzed in four subgroups reflecting the karyotype, absence/presence of androgen effects, and gender of rearing. Main outcome measures used were gender identity, friendships, love and sexual relationships, and sexual orientation in adolescents and adults with DSD. Individuals with DSD did not show increased gender dysphoria. However, partnership and sexuality were identified to be difficult areas of life. Both adolescents and adults with DSD reported fewer experiences regarding love or sexual relationships compared with unaffected individuals. Especially men with DSD and undervirilization and women with DSD and androgen effects less often had a love relationship. Adult women with DSD and androgen effects more frequently engaged in love and sexual relationships with individuals of the same gender compared with women without DSD. Individuals with DSD experience atypical hormonal influences (higher levels of androgens in girls/women and lower levels in androgens in boys/men); however, they did not show increased gender dysphoria in this study. However

  3. Clinical evaluation of ischemic heart diagnosis

    Energy Technology Data Exchange (ETDEWEB)

    Kamei, Fumio [Sendai Railway Hospital (Japan)

    1983-09-01

    Attempt were made to detect the existence of myocardial ischemia by means of both radiographic and scintigraphic techniques. Firstly, a new polygraph was especially designed for selecting the arbitrary phases in a cardiac cycle at which the corresponding radiogram should be synchronously obtained. A comparative investigation on the difference between end-systolic and-diastolic cardiac transverse diameters revealed a remarkable difference of 3.6% in normal subjects and 0.6% in patients with ischemic heart disease. These data indicating the difference of overall heart size was reflected in local dyskinesis documentation of recently developed techniques. For daily clinical purposes, radiography of the chest based on synchronously selected phases would contribute to accurate diagnosis and treatment of heart disease. Secondly, scintigraphic display using intravenously injected thallium-201 was clinically applied. For detection of ischemia, comparative study was performed of initial image relative to selective coronary cineangiography and stress scintigraphy. The former indicated a good correlation of 90%, whereas the latter served to enhance sensitivity. Sequential images (initial and delayed) facilitated the distinction of normal, necrotic, and ischemic areas. Scintigram was used for objective evaluation of coronary dilator (dilazep), either at immediate or follow-up stage. In the same way, it was also possible to indicate the effectiveness of sublingually given nitroglycerin by myocardial scintigram, where by significant increase of uptake was observed 20 minutes after administration. Rehabilitation after acute heart disease was discussed, especially on the peripheral effect. Ratio of the thigh muscle to myocardium shown in this study was useful for objective evaluation. Another preliminary study is to separate normal coronary arteries from myocardial necrosis.

  4. Clinical evaluation of ischemic heart diagnosis

    International Nuclear Information System (INIS)

    Kamei, Fumio

    1983-01-01

    Attempt were made to detect the existence of myocardial ischemia by means of both radiographic and scintigraphic techniques. Firstly, a new polygraph was especially designed for selecting the arbitrary phases in a cardiac cycle at which the corresponding radiogram should be synchronously obtained. A comparative investigation on the difference between end-systolic and-diastolic cardiac transverse diameters revealed a remarkable difference of 3.6% in normal subjects and 0.6% in patients with ischemic heart disease. These data indicating the difference of overall heart size was reflected in local dyskinesis documentation of recently developed techniques. For daily clinical purposes, radiography of the chest based on synchronously selected phases would contribute to accurate diagnosis and treatment of heart disease. Secondly, scintigraphic display using intravenously injected thallium-201 was clinically applied. For detection of ischemia, comparative study was performed of initial image relative to selective coronary cineangiography and stress scintigraphy. The former indicated a good correlation of 90%, whereas the latter served to enhnace sensitivity. Sequential images (initial and delayed) facilitated the distinction of normal, necrotic, and ischemic areas. Scintigram was used for objective evaluation of coronary dilator (dilazep), either at immediate or follow-up stage. In the same way, it was also possible to indicate the effectiveness of sublingually given nitroglycerin by myocardial scintigram, where by significant increase of uptake was observed 20 minutes after administration. Rehabilitation after acute heart disease was discussed, especially on the peripheral effect. Ratio of the thigh muscle to myocardium shown in this study was useful fer objective evaluation. Another preliminary study is to separate normal coronary arteries from myocardial necrosis. (J.P.N.)

  5. Clinical efficacy and safety evaluation of tailoring iron chelation practice in thalassaemia patients from Asia-Pacific: a subanalysis of the EPIC study of deferasirox.

    Science.gov (United States)

    Viprakasit, Vip; Ibrahim, Hishamshah; Ha, Shau-Yin; Ho, Phoebe Joy; Li, Chi-Kong; Chan, Lee-Lee; Chiu, Chang-Fang; Sutcharitchan, Pranee; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Xue, Hong-Ling; Bowden, Donald K; Lin, Kai-Hsin

    2011-03-01

    Although thalassaemia is highly prevalent in the Asia-Pacific region, clinical data on efficacy and safety profiles of deferasirox in patients from this region are rather limited. Recently, data from the multicentre Evaluation of Patients' Iron Chelation with Exjade (EPIC) study in 1744 patients with different anaemias has provided an opportunity to analyse 1115 thalassaemia patients, of whom 444 patients were from five countries in the Asia-Pacific region (AP) for whom thalassaemia management and choice of iron chelators were similar. Compared to the rest of the world (ROW), baseline clinical data showed that the AP group appeared to be more loaded with iron (3745.0 vs. 2822.0 ng/ml) and had a higher proportion on deferoxamine monotherapy prior to the study (82.9 vs. 58.9%). Using a starting deferasirox dose based on transfusional iron intake and tailoring it to individual patient response, clinical efficacy based on serum ferritin reduction in AP and ROW thalassaemia patients was similar. Interestingly, the AP group developed a higher incidence of drug-related skin rash compared to ROW (18.0 vs. 7.2%), which may indicate different pharmacogenetic backgrounds in the two populations. Our analysis confirms that, with appropriate adjustment of dose, deferasirox can be clinically effective across different regions, with manageable side effects.

  6. Evaluating impact of clinical guidelines using a realist evaluation framework.

    Science.gov (United States)

    Reddy, Sandeep; Wakerman, John; Westhorp, Gill; Herring, Sally

    2015-12-01

    The Remote Primary Health Care Manuals (RPHCM) project team manages the development and publication of clinical protocols and procedures for primary care clinicians practicing in remote Australia. The Central Australian Rural Practitioners Association Standard Treatment Manual, the flagship manual of the RPHCM suite, has been evaluated for accessibility and acceptability in remote clinics three times in its 20-year history. These evaluations did not consider a theory-based framework or a programme theory, resulting in some limitations with the evaluation findings. With the RPHCM having an aim of enabling evidence-based practice in remote clinics and anecdotally reported to do so, testing this empirically for the full suite is vital for both stakeholders and future editions of the RPHCM. The project team utilized a realist evaluation framework to assess how, why and for what the RPHCM were being used by remote practitioners. A theory regarding the circumstances in which the manuals have and have not enabled evidence-based practice in the remote clinical context was tested. The project assessed this theory for all the manuals in the RPHCM suite, across government and aboriginal community-controlled clinics, in three regions of Australia. Implementing a realist evaluation framework to generate robust findings in this context has required innovation in the evaluation design and adaptation by researchers. This article captures the RPHCM team's experience in designing this evaluation. © 2015 John Wiley & Sons, Ltd.

  7. Clinical Evaluation of Efficacy and Performance of All-Poly Tibial Freedom® Total Knee System for Treating Osteoarthritis Patients: Three-Year Follow Up Study.

    Science.gov (United States)

    Singh, Avatar; Singh, Kanwar Kulwinder

    2017-09-01

    Advancement in technology in terms of design and building materials has made Total Knee Replacement (TKR) a highly effective, safe, and predictable orthopedic procedure. To review the clinical outcomes for efficacy and performance of Freedom Total Knee System for the management of Osteoarthritis (OA), at a minimum of three years follow up. For this retrospective, post-marketing study, clinical data of patients treated with Freedom Total Knee System was retrieved from the clinical records after approval from the Institutional Ethics Committee . All the patients above the age of 18 years who completed at least three years after TKR were observed for the study purpose. Patients treated for OA were included while the patients who received the implant for treatment of rheumatoid arthritis and traumatic injury were excluded. Factors such as aseptic loosening, implant failure, and need for revision surgery were observed to evaluate implant performance. Cases were recruited for clinical assessment of primary efficacy endpoint in terms of post-surgery maximun range of motion. Secondary efficacy endpoint was to determine the clinical and social quality of life as per the American Knee Society Score (AKSS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and stiffness scores. A total of 158 patients who had 191 TKR were observed for performance. The mean age of the patients was 67.67 years; mean BMI was 28.97±3.33, and the group comprised of 43% men and 57% women. Telephonic follow up at three years of 158 patients identified that none of them required revision surgery or had aseptic loosening suggesting excellent performance. Final clinical follow up at three years was available for only 35 patients (41 knee implants). The range of motion significantly improved from preoperative 104°±5.67° (range, 85°-119°) to 119.8°±11.05° (98°-123°) at follow-up (ppain, and improved functionality.

  8. The presence of nonthoracic distracting injuries does not affect the initial clinical examination of the cervical spine in evaluable blunt trauma patients: a prospective observational study.

    Science.gov (United States)

    Konstantinidis, Agathoklis; Plurad, David; Barmparas, Galinos; Inaba, Kenji; Lam, Lydia; Bukur, Marko; Branco, Bernardino C; Demetriades, Demetrios

    2011-09-01

    A distracting injury mandates cervical spine (c-spine) imaging in the evaluable blunt trauma patient who demonstrates no pain or tenderness over the c-spine. The purpose of this study was to examine which distracting injuries can negatively affect the sensitivity of the standard clinical examination of the c-spine. This is a prospective observational study conducted at a Level I Trauma Center from January 1, 2008, to December 31, 2009. After institutional review board approval, all evaluable (Glasgow Coma Scale score ≥13) blunt trauma patients older than 16 years sustaining a c-spine injury were enrolled. A distracting injury was defined as any immediately evident bony or soft tissue injury or a complaint of non-c-spine pain whether or not an actual injury was subsequently diagnosed. Information regarding the initial clinical examination and the presence of a distracting injury was collected from the senior resident or attending trauma surgeon involved in the initial management. During the study period, 101 evaluable patients sustained a c-spine injury. Distracting injuries were present in 88 patients (87.1%). The most common was rib fracture (21.6%), followed by lower extremity fracture (20.5%) and upper extremity fracture (12.5%). Only four (4.0%) patients had no pain or tenderness on the initial examination of the c-spine. All four patients had bruising and tenderness to the upper anterior chest. None of these four patients developed neurologic sequelae or required a surgical stabilization or immobilization. C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest. Further definition of distracting injuries is mandated to avoid unnecessary utilization of resources and to reduce the imaging burden associated with the evaluation of the c-spine.

  9. Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

    Science.gov (United States)

    Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

    2000-08-01

    Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning

  10. Evaluation of a filmed clinical scenario as a teaching resource for an introductory pharmacology unit for undergraduate health students: A pilot study.

    Science.gov (United States)

    East, Leah; Hutchinson, Marie

    2015-12-01

    Simulation is frequently being used as a learning and teaching resource for both undergraduate and postgraduate students, however reporting of the effectiveness of simulation particularly within the pharmacology context is scant. The aim of this pilot study was to evaluate a filmed simulated pharmacological clinical scenario as a teaching resource in an undergraduate pharmacological unit. Pilot cross-sectional quantitative survey. An Australian university. 32 undergraduate students completing a healthcare degree including nursing, midwifery, clinical science, health science, naturopathy, and osteopathy. As a part of an undergraduate online pharmacology unit, students were required to watch a filmed simulated pharmacological clinical scenario. To evaluate student learning, a measurement instrument developed from Bloom's cognitive domains (knowledge, comprehension, application, analysis, synthesis and evaluation) was employed to assess pharmacological knowledge conceptualisation and knowledge application within the following fields: medication errors; medication adverse effects; medication interactions; and, general pharmacology. The majority of participants were enrolled in an undergraduate nursing or midwifery programme (72%). Results demonstrated that the majority of nursing and midwifery students (56.52%) found the teaching resource complementary or more useful compared to a lecture although less so compared to a tutorial. Students' self-assessment of learning according to Bloom's cognitive domains indicated that the filmed scenario was a valuable learning tool. Analysis of variance indicated that health science students reported higher levels of learning compared to midwifery and nursing. Students' self-report of the learning benefits of a filmed simulated clinical scenario as a teaching resource suggest enhanced critical thinking skills and knowledge conceptualisation regarding pharmacology, in addition to being useful and complementary to other teaching and

  11. Comparative evaluation of coronally advanced flap using amniotic membrane and platelet-rich fibrin membrane in gingival recession: An 18-month clinical study

    Directory of Open Access Journals (Sweden)

    Mohd Rehan

    2018-01-01

    Full Text Available Background: An amnion membrane is a placenta-derived tissue that consists of numerous growth factors, proteins, and stem cell reserves which help in accelerated wound healing and regeneration. Platelet-rich fibrin (PRF also releases growth factors after activation from the platelets and gets trapped within fibrin matrix which has been shown to stimulate the mitogenic response in the periosteum for bone repair and regeneration during normal wound healing. This preliminary, controlled, randomized clinical trial with an 18-month follow-up was aimed to evaluate the effectiveness of coronally advanced flap (CAF with either PRF membrane or bioresorbable amniotic membrane (AM in treatment of localized gingival recession defects. Materials and Methods: Sixteen healthy adult patients presenting with Miller Class I recession defects were treated surgically with CAF along with AM (Group I or PRF (Group II for coverage of the recession defects. For all patients, plaque index, gingival index, bleeding on probing, clinical attachment level, depth of recession, width of recession, width of attached gingiva, and gingival thickness were evaluated at 6 months and 18 months postoperatively. Statistical analysis was done using paired t-test, repeated measure analysis of variance test, Bonferroni test for intragroup comparison and unpaired t-test for intergroup comparison. Results: The results showed statistically nonsignificant (P < 0.01 difference in all clinical parameters at the 6- and 18-month follow-ups in both groups. Gingival recession in both PRF and amnion group when evaluated individually, significantly reduced from baseline to 6 months (P = 0.000 and from baseline to 18 months (P = 0.000. However, the mean value from 6 months to 18 months was statistically nonsignificant. Conclusion: The present study demonstrated that both CAF + PRF and CAF + AM are equally effective in providing clinically significant outcomes with respect to root coverage with AM

  12. Clinical evaluation of synthetic aperture sequential beamforming

    DEFF Research Database (Denmark)

    Hansen, Peter Møller; Hemmsen, Martin Christian; Lange, Theis

    2012-01-01

    In this study clinically relevant ultrasound images generated with synthetic aperture sequential beamforming (SASB) is compared to images generated with a conventional technique. The advantage of SASB is the ability to produce high resolution ultrasound images with a high frame rate and at the same...... time massively reduce the amount of generated data. SASB was implemented in a system consisting of a conventional ultrasound scanner connected to a PC via a research interface. This setup enables simultaneous recording with both SASB and conventional technique. Eighteen volunteers were ultrasound...... scanned abdominally, and 84 sequence pairs were recorded. Each sequence pair consists of two simultaneous recordings of the same anatomical location with SASB and conventional B-mode imaging. The images were evaluated in terms of spatial resolution, contrast, unwanted artifacts, and penetration depth...

  13. Scintiscan studies as well as clinical and laboratory examinations to evaluate the therapeutic success achieved with gold salts and D-penicillamine in rheumatoid arthritis

    International Nuclear Information System (INIS)

    Doerwald, K.

    1986-01-01

    Comparative evaluations of findings revealed by semiquantitative scintiscanning using 99m-Tc pyrophosphate and the results of relevant clinical examinations and determinations of the blood sedimentation rate were carried out as part of a follow-up study in 35 patients treated for rheumatoid arthritis. Their reliability was judged as follows: 1) Inflamed joints were easily discernable on the scintiscans, which permitted a more accurate diagnosis to be made than the clinical findings. 2) The methods under investigation led to largely consistent results, as far as medical surveillance and predictions of patient outcome were concerned. 3) On the basis of a six-month observation period the therapeutic strategies followed (gold salts and D-penicillamine) were considered to be equally effective, the dose regimes being adapted to the individual requirements. (TRV) [de

  14. Assessment of viability by quantitative evaluation of 24h-redistribution in 201-thallium myocardial scintigraphy (SPECT): A comparative study versus clinical follow-up after revascularisation

    International Nuclear Information System (INIS)

    Stirner, H.; Spreng, M.; Picker, D.; Pfafferott, C.

    1992-01-01

    Results of regional quantitative assessment of 24h-redistribution in routinely performed Thallium myocardial scintigraphy (SPECT) were compared to findings of coronary angiography/ventriculography and/or echocardiography as well as clinical status 6 months after revascularisation in up to now 34 patients. In respect of positive and negative predictive values evaluation of 24h-redistribution behaves best (81/100%) compared to perfusion and 3h-redistribution alone. Performing an additional 24h-study gives a gain of at least 80% of diagnostic information. (orig.) [de

  15. Non-clinical immuno-toxicological evaluation of HER1 cancer vaccine in non-human primates: a 12-month study.

    Science.gov (United States)

    Barro, Ana M Bada; Rivero, Arianna Iglesias; Goñi, Avelina León; Navarro, Bárbara O González; Angarica, Meilis Mesa; Ramírez, Belinda Sánchez; Bedoya, Darel Martínez; Triana, Consuelo González; Rodríguez, Axel Mancebo; Parada, Ángel Casacó

    2012-12-17

    Human epidermal growth factor receptor (HER1) constitutes a tumor associated antigen. Its overexpression in many epithelial tumors has been associated with bad prognosis and poor survival. Cancer vaccine based on the extracellular domain (ECD) of HER1 and adjuvated in very small sized proteoliposomes (VSSP) and Montanide ISA 51-VG is a new and complementary approach for the treatment of epithelial tumors. The present study deals with the immunogenicity of this vaccine in Macaca fascicularis monkeys and evaluation of its toxicity during 12 months. Twelve monkeys were randomized into two groups of 3 animals per sex: control and vaccinated. Treated monkeys received 9 doses of vaccination and were daily inspected for clinical signs. Body weight, rectal temperature, cardiac and respiratory rates were measured during the study. Humoral immune response, clinical pathology parameters and delayed type hypensensitivity were analyzed. Skin biopsy was performed at the end of the study in all animals. Animal's survival in the study was 100% (n=12). Local reactions were observed at the administration site of four treated animals (n=6), with two showing slight inflammatory cutaneous damage. Clinical pathology parameters were not affected. HER1 vaccine induced high IgG antibodies titers in the treated animals even when DTH was not observed. The induced antibodies recognized HER1+ tumor cell lines, decreased HER1 phosphorylation and showed anti-proliferative and pro-apoptotic effects in H125 cells. In general the present study showed that HER1 vaccine induced specific immune response in M. fascicularis monkeys and was well tolerated, suggesting it could be safely used in clinical studies in epithelial cancer patients. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. Evaluation of moxifloxacin-hydroxyapatite composite graft in the regeneration of intrabony defects: A clinical, radiographic, and microbiological study

    Directory of Open Access Journals (Sweden)

    Y V Nagarjuna Reddy

    2016-01-01

    Full Text Available Background: The formation of new connective periodontal attachment is contingent upon the elimination or marked reduction of pathogens at the treated periodontal site. An anti-microbial agent, i.e. moxifloxacin has been incorporated into the bone graft to control infection and facilitate healing during and after periodontal therapy. Materials and Methods: By purposive sampling, 15 patients with at least two contralateral vertical defect sites were selected. The selected sites in each individual were divided randomly into test and control sites according to split-mouth design. Test site received moxifloxacin-hydroxyapatite composite graft and control site received hydroxyapatite-placebo gel composite graft. Probing depth (PD and Clinical attachment level (CAL were assessed at baseline, 3, 6, 9, and 12 months. Bone probing depth (BPD and hard tissue parameters such as amount of defect fill, percentage of defect fill, and changes in alveolar crest were assessed at baseline, 6, and 12 months. Changes in subgingival microflora were also assessed by culturing the subgingival plaque samples at baseline and at 3-month follow-up. The clinical, radiographic, and microbiological data obtained were subjected to statistical analysis using descriptive statistics, paired sample t-test, independent t-test, and contingency test. Results: On intragroup comparison at test and control sites, there was a significant improvement in all clinical and radiographic parameters. However, on intergroup comparison of the same, there was no statistically significant difference between test and control sites at any interval. Although test sites showed slightly higher amount of bone fill, it was not statistically significant. There was a significant reduction in the counts of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis at both sites from baseline to 3 months. In addition, there was a significant reduction at test sites as compared to control sites at 3

  17. Polycystic ovary syndrome: clinical and laboratory evaluation

    Directory of Open Access Journals (Sweden)

    Marcos Yorghi Khoury

    Full Text Available OBJECTIVE: To evaluate clinically, and with laboratory, tests, women with polycystic ovary syndrome (PCO. PATIENTS: One hundred and twelve women with PCO were studied. METHODS: The following data was recorded: Current age; age at menarche; menstrual irregularity, occurrence of similar cases in the family; fertility, obstetric history; body mass index (BMI; and presence of hirsutism. Serum measurements of follicle stimulating hormone (FSH, luteinizing hormone (LH, prolactin, free testosterone, and dehydroepiandrosterone sulfate were taken. RESULTS: All patients presented either oligomenorrhea (31 percent, periods of secondary amenorrhea (9 percent, or both alterations (60 percent. The majority of the patients were infertile (75.6 percent. The LH/FSH ratio was higher than 2:1 in 55 percent of the patients and higher than 3:1 in 26.2 percent. The ultrasonographic aspect of the ovaries was considered to be normal in 31 percent. CONCLUSION: The main clinical feature of the PCO is the irregularity of menses since menarche, and that the laboratory tests would be important to exclude other disorders such as hyperprolactinemia or hyperandrogenemia caused by late-onset congenital adrenal hyperplasia.

  18. [Development and clinical evaluation of an anesthesia information management system].

    Science.gov (United States)

    Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

    2010-09-21

    To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

  19. A Clinical Evaluation of Definitive and Clinical Allergic Bronchopulmonary Mycosis

    OpenAIRE

    Matsuse, Hiroto; Nakata, Hiroko; Fukahori, Susumu; Tsuchida, Tomoko; Kawano, Tetsuya; Tomari, Shinya; Fukushima, Chizu; Matsuo, Nobuko; Asai, Sadahiro; Kohno, Shigeru

    2006-01-01

    Objective: The present study aims to overcome problems associated with the early diagnosis of allergic bronchopulmonary mycosis (ABPM) using the current criteria. Patients and Methods: Clinical features including radiographic findings from 10 patients with definitive ABPM based on the diagnostic criteria of Rosenberg-Patterson were compared with those from 9 patients with ABPM clinically diagnosed by respiratory allergy specialists. Results: ABPM should be considered in patients with peripher...

  20. The clinical application study of bone marrow immunoscintigraphy using 99Tcm-BW250/183 in evaluating patients with aplastic anemia

    International Nuclear Information System (INIS)

    Liu Zengli; Wu Jinchang; Tang Jun; Wang Wei

    2002-01-01

    Objective: To study the clinical value of bone marrow immunoscintigraphy for evaluation of patients with aplastic anemia. Methods: Twelve patients with aplastic anemia underwent bone marrow immunoscintigraphy using 99 Tc m labelled anti-granulocyte monoclonal antibody BW250/183, 10 of them also underwent bone marrow imaging using 99 Tc m -sulfur colloid (SC) 2 - 3 days later. The semiquantitative indexes of bone marrow immunoscintigraphy of the patients were compared with those of control patients. Results: Bone marrow immunoscintigraphy was superior to 99 Tc m -SC bone marrow imaging. In patients with aplastic anemia, the accumulation of 99 Tc m -BW250/183 in bone marrow and spleen was lower and in liver and kidney was higher than those of control patients. Nine patients were found with multiple focal accumulation in bone marrow. Conclusion: Bone marrow immunoscintigraphy with 99 Tc m -BW250/183 plays an important role in evaluating patients with aplastic anemia

  1. Clinical simulation as an evaluation method in health informatics

    DEFF Research Database (Denmark)

    Jensen, Sanne

    2016-01-01

    Safe work processes and information systems are vital in health care. Methods for design of health IT focusing on patient safety are one of many initiatives trying to prevent adverse events. Possible patient safety hazards need to be investigated before health IT is integrated with local clinical...... work practice including other technology and organizational structure. Clinical simulation is ideal for proactive evaluation of new technology for clinical work practice. Clinical simulations involve real end-users as they simulate the use of technology in realistic environments performing realistic...... tasks. Clinical simulation study assesses effects on clinical workflow and enables identification and evaluation of patient safety hazards before implementation at a hospital. Clinical simulation also offers an opportunity to create a space in which healthcare professionals working in different...

  2. Randomized, controlled clinical study to evaluate efficacy of novel indigenously designed controlled release flurbiprofen gel system for management of periodontal diseases

    Directory of Open Access Journals (Sweden)

    Neeraj C Deshpande

    2013-01-01

    Full Text Available Background: This randomized, controlled clinical study was planned to evaluate the use of anti-inflammatory drug flurbiprofen in the form of locally delivered controlled release gel in the treatment of periodontal disease. Materials and Methods: The flurbiprofen gel was indigenously prepared in the concentration of 0.3%. The 30 patients with localized periodontal pockets measuring ≥5 mm were randomly divided into three groups. The groups received flurbiprofen gel, flurbiprofen gel after prophylaxis, and placebo gel after oral prophylaxis, respectively. The clinical parameters for plaque and gingival inflammation were evaluated at baseline, 7 th day, and 14 th day. Results: The results of the study suggested the statistically significant ( P < 0.05 improvement in the gingival status of the patients with the use of flurbiprofen gel as an adjunct to scaling and root planing as compared to oral prophylaxis or gel alone. Conclusion: The data demonstrated that the additional use of local drug delivery of flurbiprofen through gel media enhances the positive effects of scaling and root planing and helps in faster resolution of the inflammation.

  3. Evaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study

    Directory of Open Access Journals (Sweden)

    Martiniuk Alexandra

    2011-11-01

    Full Text Available Abstract Background Nearly 3 million people in resource-poor countries receive antiretrovirals for the treatment of HIV/AIDS, yet millions more require treatment. Key barriers to treatment scale up are shortages of trained health care workers, and challenges integrating HIV/AIDS care with primary care. The research PALM PLUS (Practical Approach to Lung Health and HIV/AIDS in Malawi is an intervention designed to simplify and integrate existing Malawian national guidelines into a single, simple, user-friendly guideline for mid-level health care workers. Training utilizes a peer-to-peer educational outreach approach. Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi. The research consists of a cluster randomized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention, quality of patient care, and costs through quantitative, qualitative and health economics methods. Results and outcomes In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites. Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients. Interim staff retention data shows that there were, on average, 3 to 4 staff departing from the control and intervention sites per month. Additional qualitative, quantitative and economic analyses are planned. The partnership Dignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention, using experience gained through the implementation of the South African precursor, PALSA PLUS. The Malawian partners, REACH Trust and the Research Unit at the Ministry of Health, have led the qualitative and

  4. Evaluating a streamlined clinical tool and educational outreach intervention for health care workers in Malawi: the PALM PLUS case study.

    Science.gov (United States)

    Sodhi, Sumeet; Banda, Hastings; Kathyola, Damson; Burciul, Barry; Thompson, Sandy; Joshua, Martias; Bateman, Eric; Fairall, Lara; Martiniuk, Alexandra; Cornick, Ruth; Faris, Gill; Draper, Beverley; Mondiwa, Martha; Katengeza, Egnat; Sanudi, Lifah; Zwarenstein, Merrick; Schull, Michael J

    2011-11-08

    Nearly 3 million people in resource-poor countries receive antiretrovirals for the treatment of HIV/AIDS, yet millions more require treatment. Key barriers to treatment scale up are shortages of trained health care workers, and challenges integrating HIV/AIDS care with primary care. PALM PLUS (Practical Approach to Lung Health and HIV/AIDS in Malawi) is an intervention designed to simplify and integrate existing Malawian national guidelines into a single, simple, user-friendly guideline for mid-level health care workers. Training utilizes a peer-to-peer educational outreach approach. Research is being undertaken to evaluate this intervention to generate evidence that will guide future decision-making for consideration of roll out in Malawi. The research consists of a cluster randomized trial in 30 public health centres in Zomba District that measures the effect of the intervention on staff satisfaction and retention, quality of patient care, and costs through quantitative, qualitative and health economics methods. In the first phase of qualitative inquiry respondents from intervention sites demonstrated in-depth knowledge of PALM PLUS compared to those from control sites. Participants in intervention sites felt that the PALM PLUS tool empowered them to provide better health services to patients. Interim staff retention data shows that there were, on average, 3 to 4 staff departing from the control and intervention sites per month. Additional qualitative, quantitative and economic analyses are planned. Dignitas International and the Knowledge Translation Unit at the University of Cape Town Lung Institute have led the adaptation and development of the PALM PLUS intervention, using experience gained through the implementation of the South African precursor, PALSA PLUS. The Malawian partners, REACH Trust and the Research Unit at the Ministry of Health, have led the qualitative and economic evaluations. Dignitas and Ministry of Health have facilitated interaction with

  5. Clinical study of pulmonary infection caused by mycobacterium avium complex. Evaluation of radiographic features on the primary pulmonary infection

    International Nuclear Information System (INIS)

    Harada, Yasuko; Harada, Susumu; Kitahara, Yoshinari; Kajiki, Akira; Maruyama, Masao; Takamoto, Masahiro; Ishibashi, Tsuneo

    1996-01-01

    During the 13 year period of 1982 to 1994 we had 103 patients with pulmonary Mycobacterium avium complex (MAC) infections. All met the criteria of atypical mycobacteriosis (Japanese Mycobacteriosis Research Group of the National Chest Hospitals). Of 103 patients 70 had no underlying pulmonary diseases and classified as primary type. Radiographic features of chest X-rays or computed tomography (CT) of primary infection were evaluated. Results obtained were as follows: Primary infection of MAC was classified into two types. One was localized type. This type was further classified into three patterns; tuberculosis-like pattern, pneumonia pattern in the lingual and/or middle lobe and pneumonia pattern in other lobes. Another one was diffuse type. Tuberculosis-like pattern was most common in males. On the other hand, the pneumonia pattern and the diffuse type were most common in females. Four characteristic features were seen as follows (Type 1-4) in the chest CT examination of diffuse pattern. Type 1: Nodules near the pleura. Type 2: Nodules with subpleural thickening. Type 3: Bronchial wall thickening and ectatic change of the draining bronchi. Type 4: Cystic bronchiectatic change associated with atelectasis of the segment or the lobe. Bronchiectatic changes became severe and widespreaded in all lung fields as the disease progressed slowly. These findings were more prevalent in the lingual and/or middle lobe than the other lobes. (author)

  6. Clinical study of GFR and split renal GFR in evaluating the glomerular function in patients with type 2 diabetes

    International Nuclear Information System (INIS)

    Fu Hongliang; Li Jinsong; Li Jianing; Wu Jingchuan; Yang Shurong; Gu Zhenhui; Zou Renjian; Shi Haihong

    2003-01-01

    Objective: To assess glomerular filtration function in patients with type 2 diabetes by glomerular filtration rate (GFR) and split GFR, namely left GFR (LGFR) and right GFR (RGFR). Methods: Fifty-one patients with type 2 diabetes were classified by urine albumin analysis into three groups, normalalbuminuria group (NA), microalbuminuria group(MA) and macroalbuminuria group (MAA) . Twelve patients without diabetes were included into control group. 99 Tc m -DTPA renography was performed on all these cases. GFR and split GFR were calculated by Gates formula. Results: 1) GFR, LGFR and RGFR of NA group were lower than that of the control group. 2) GFR, LGFR and RGFR were significantly correlated with the urine albumin level (r=-0.457, -0.412, -0.424, respectively, P all < 0.01). 3) In all 51 cases, there were 5 cases whose GFR were normal while split GFR were abnormal. Conclusions: 1) GFR and split GFR measurement can detect the incipient damage of glomerular function more sensitively than urine albumin analysis and show the degree of the damage correctly. 2) Split GFR measurement can improve the evaluation of the glomerular function in type 2 diabetes patients

  7. Clinical study to evaluate the Brinhaniya effect of Vidarikandadi Yog to enhance the sport performance in children

    Directory of Open Access Journals (Sweden)

    Nilesh Manohar Ingle

    2013-01-01

    Full Text Available Background: Sport science studies applications of scientific principles and techniques with the aim of improving sports performance. Objective: Present research work was carried out with the aim to enhance the sport performance of children. Materials and Methods: Randomized double blind placebo controlled study was conducted in children involved in sports to assess the efficacy of trial drug "Vidarikandadi Yog". Total of 72 healthy students were selected for the study after screening 412 students. Out of them, 60 students completed the study. The students were randomly divided into two groups. Group A (Vidarikandadi Yog comprising of 38 and Group B (placebo of 34 students. The trial drug "Vidarikandadi Yog" was given in the dose of 200 mg/kg/day in two divided doses for 2 months with milk and follow up was conducted fortnightly. Results: The study revealed the statistically significant results for weight and chest circumference, whereas highly significant results were obtained for muscular strength and endurance assessment parameters (Push-up Test, Sit-up Test, and Hand Grip Strength Test. Change in Ruler Drop Test was not significant. Results were significant for cardio-respiratory parameters (Resting Heart Rate, Resting Respiratory Rate, and Harvard Step Test. Conclusion: Vidarikandadi Yog is a potential drug for enhancing the sport performance due to its Brinhaneeya effect.

  8. Clinical evaluation of the intraoral fluoride releasing system in radiation-induced xerostomic subjects. Part 2: Phase I study.

    Science.gov (United States)

    Chambers, Mark S; Mellberg, James R; Keene, Harris J; Bouwsma, Otis J; Garden, Adam S; Sipos, Tibor; Fleming, Terence J

    2006-10-01

    Radiation-induced xerostomia can result in the rapid onset and progression of dental caries in head and neck cancer patients. Topically applied fluorides have been successfully used to inhibit the formation of dental caries in this population. However, because intensive daily self-application is required, compliance is an issue. The intraoral fluoride-releasing system (IFRS) containing a sodium fluoride core is a newly developed, sustained-release, passive drug delivery system that does not require patient involvement except for periodic replacement, thus reducing the effect of patient compliance on its effectiveness in dental caries prevention. Twenty-two head and neck cancer patients from U. T. M. D. Anderson Cancer Center, with radiation-induced xerostomia, were entered into a pilot study to contrast the daily home use of a 0.4% stannous fluoride-gel-containing tray (control group) to IFRS (study group) with respect to tolerability and adherence, and to obtain information on relative caries preventive efficacy. Participants were stratified on the basis of radiation exposure and randomly assigned to treatment with either IFRS or stannous fluoride gel. Patients in both groups were fitted with two IFRS retainers and also were instructed to use a 1100-ppm fluoride conventional sodium fluoride dentifrice twice daily. The study was conducted as a single-blinded, parallel-cell trial. Pre-existing carious lesions were restored prior to the beginning of the study. The efficacy variable was determined by the mean number of new or recurrent decayed surfaces. Patients were examined for caries 4, 8, 12, 24, 36, and 48 weeks after initiation of treatment. Reports of adverse reactions were based on information volunteered by patients and that were elicited during interviews. At baseline, the resting and stimulated salivary flow rates (g/5min) were significantly greater in the control group than in the study group (pIFRS groups during the study period. The rate of new or

  9. Evaluation of Sentinel Node Biopsy in Locally Advanced Breast Cancer Patients Who Become Clinically Node-Negative after Neoadjuvant Chemotherapy: A Preliminary Study

    International Nuclear Information System (INIS)

    Thomas, Sh.; Prakash, A.; Goyal, V.; Agarwal, Sh.; Choudhury, M.; Popli, M.B.

    2011-01-01

    Introduction. Controversy continues over the appropriate timing of sentinel lymph node (SLN) biopsy in locally advanced breast cancer (LABC) patients receiving neoadjuvant chemotherapy. We evaluated the feasibility and accuracy of SLN biopsy in LABC patients with cytology-proven axillary nodal metastasis who become clinically node-negative after neoadjuvant chemotherapy. Materials. 30 consecutive patients with LABC, who had become clinically node-negative after 3 cycles of neoadjuvant chemotherapy, were included in the study. They were then subjected to SLN biopsy, axillary lymph node dissection, and breast surgery. Results. Sentinel nodes were successfully identified in 26 of the 30 patients, resulting in an identification rate of 86.67%, sensitivity of 83.33%, false negative rate of 20%, negative predictive value of 72.73%, and an overall accuracy of 88.46%. No complications were observed as a result of dye injection. Conclusions. SLN biopsy is feasible and safe in LABC patients with cytology-positive nodes who become clinically node-negative after neoadjuvant chemotherapy. Our accuracy rate, identification rate, and false negative rate are comparable to those in node-negative LABC patients. SLN biopsy as a therapeutic option in LABC after neoadjuvant chemotherapy is a promising option which should be further investigated

  10. A comparative evaluation of the blood clot, platelet-rich plasma, and platelet-rich fibrin in regeneration of necrotic immature permanent teeth: A clinical study

    Directory of Open Access Journals (Sweden)

    Isha Narang

    2015-01-01

    Full Text Available Introduction: This study was designed as a clinical trial to evaluate and compare the regenerative potential of platelet-rich fibrin (PRF, platelet-rich plasma (PRP, and blood clot in immature necrotic permanent teeth with or without associated apical periodontitis. Methods: Access preparation was done under rubber dam isolation. Copious irrigation was done with 2.5% NaOCl and triple antibiotic paste was placed as an intracanal medicament. After 4 weeks, the cases were divided into four groups with five patients in each group. The study design had three test arms and one control arm. Group I in which mineral trioxide aggregate apexification was carried out and it was kept as control group to evaluate the regenerative potential of blood clot and platelet concentrates, Group II in which blood clot was used as scaffold in the canal, Group III in PRF was used as scaffold, and Group IV in which PRP carried on collagen was used as a scaffold. Results: The clinical and radiographic evaluation after 6 and 18 months was done by two independent observers who were blinded from the groups. The scoring was done as: None score was denoted by, Fair by 1, Good by 2, and Excellent by 3. The data were then analyzed statistically by Fisher′s exact test using Statistics and Data 11.1(PRP Using harvest Smart PReP2 which showed statistically significant values in Group III as compared to other Groups. Conclusion: PRF has huge potential to accelerate the growth characteristics in immature necrotic permanent teeth as compared to PRP and blood clot.

  11. Clinical evaluation of unselected cardiac arrest survivors in a tertiary center over a 1-yearperiod (the LAZARUZ study)

    DEFF Research Database (Denmark)

    Marstrand, P.; Corell, P; Henriksen, F. L.

    2016-01-01

    Objectives: When the cause of an aborted cardiac arrest is unclear the initiation of therapy, counseling and family screening is challenging. Methods: We included 43 unselected, prospectively identified cardiac arrest survivors with or without a diagnosis. Family history for cardiac disease...... of the electrocardiogram. We suggest that these ECG derived clues be investigated in future studies including genetic test results and data from relatives. (C) 2016 Elsevier Inc. All rights reserved....

  12. A Randomized Clinical Study to Evaluate the Effect of Two Experimental Toothpastes on Tooth Enamel Gloss and Smoothness.

    Science.gov (United States)

    Milleman, Kimberly R; Milleman, Jeffery L; Creeth, Jonathan E; Butler, Andrew; Bosma, Mary Lynn

    2016-03-01

    The study compared the effects on examiner-assessed tooth gloss and smoothness of two experimental toothpastes (1% or 2% alumina abrasive) with a reference, silica-based toothpaste used twice daily for one, four, and eight weeks. The study also monitored the safety of the products. This was a randomized, examiner-blind study, stratified by gloss score and age, three-treatment, parallel-group using healthy adult volunteers. Following a two-week washout period where subjects brushed with a conventional silica-abrasive toothpaste, 169 subjects began the trial period after receiving a dental scaling and polishing using the washout toothpaste. Subjects brushed for two minutes, twice daily, with their assigned toothpaste. The experimental toothpastes contained 927 ppm fluoride as NaF with either 1% or 2% alumina as the sole abrasive. The reference toothpaste contained 927 ppm fluoride as NaF in a conventional amorphous silica abrasive base. Enamel polish (i.e., gloss) was assessed visually by comparing the facial surfaces of the maxillary incisors with a set of standards. Tooth smoothness was assessed by lightly dragging a dental explorer over the surface. Subjects using the 2% alumina toothpaste had significantly higher gloss compared to the reference toothpaste at Weeks 1 and 4, but the difference was of borderline significance at Week 8 (one-covariate analysis: p = 0.0529; two-covariate analysis: p = 0.0494). Subjects using the 1% alumina toothpaste had significantly higher gloss improvement scores than the reference toothpaste at Weeks 4 and 8, but not at Week 1. All three treatment groups' gloss scores improved during the study. Regarding tooth smoothness, the effects of the experimental toothpastes followed a broadly similar profile to the effects on tooth gloss. After four weeks' use, both experimental toothpastes were superior to the reference. After eight weeks' use, however, only the 2% alumina toothpaste approached significant superiority versus the reference

  13. Evaluation of primary stability of self-tapping and non-self-tapping dental implants. A 12-week clinical study.

    Science.gov (United States)

    Marković, Aleksa; Calvo-Guirado, José Luís; Lazić, Zoran; Gómez-Moreno, Gerardo; Ćalasan, Dejan; Guardia, Javier; Čolic, Snježana; Aguilar-Salvatierra, Antonio; Gačić, Bojan; Delgado-Ruiz, Rafael; Janjić, Bojan; Mišić, Tijana

    2013-06-01

    The aim of this study was to investigate the relationship between surgical techniques and implant macro-design (self-tapping/non-self-tapping) for the optimization of implant stability in the low-density bone present in the posterior maxilla using resonance frequency analysis (RFA). A total of 102 implants were studied. Fifty-six self-tapping BlueSkyBredent® (Bredent GmbH&Co.Kg®, Senden, Germany) and 56 non-self-tapping Standard Plus Straumann® (Institut Straumann AG®, Waldenburg, Switzerland) were placed in the posterior segment of the maxilla. Implants of both types were placed in sites prepared with either lateral bone-condensing or with bone-drilling techniques. Implant stability measurements were performed using RFA immediately after implant placement and weekly during a 12-week follow-up period. Both types of implants placed after bone condensing achieved significantly higher stability immediately after surgery, as well as during the entire 12-week observation period compared with those placed following bone drilling. After bone condensation, there were no significant differences in primary stability or in implant stability after the first week between both implant types. From 2 to 12 postoperative weeks, significantly higher stability was shown by self-tapping implants. After bone drilling, self-tapping implants achieved significantly higher stability than non-self-tapping implants during the entire follow-up period. The outcomes of the present study indicate that bone drilling is not an effective technique for improving implant stability and, following this technique, the use of self-tapping implants is highly recommended. Implant stability optimization in the soft bone can be achieved by lateral bone-condensing technique, regardless of implant macro-design. © 2011 Wiley Periodicals, Inc.

  14. clinical and experimental study

    OpenAIRE

    Tornow, Christoph

    2011-01-01

    Posterior capsule opacity (PCO) is a frequent complication in extracapsular cataract extraction in conjunction with an intraocular lens implant. Different studies have shown that a reduction in PCO frequency can be achieved via a number of factors. Lens design is a significant criterion in this process. In this study, two multifocal intraocular lenses (MIOLs) were compared. The design of these lenses differed due to their varying optical principles. They are the refractive MIOL A...

  15. Clinical evaluation of XaraColl®, a bupivacaine-collagen implant, for postoperative analgesia in two multicenter, randomized, double-blind, placebo-controlled pilot studies

    Directory of Open Access Journals (Sweden)

    Cusack SL

    2012-06-01

    Full Text Available Susan L Cusack,1 Mark Jaros,2 Michael Kuss,3 Harold S Minkowitz,4 Peter Winkle,5 Lisa Hemsen61Cusack Pharmaceutical Consulting, Burlington, NJ, 2Summit Analytical, Denver, CO, USA; 3Premier Research Group, Austin, TX, USA; 4Memorial Hermann Memorial City Medical Center, Houston, TX, USA; 5Advanced Clinical Research Institute, Anaheim, CA, USA; 6Innocoll Technologies, Athlone, IrelandBackground: XaraColl®, a collagen-based implant that delivers bupivacaine to the site of surgical trauma, is under development for postoperative analgesia. Because of differing patient attitudes to postoperative pain control and the inability to assess baseline pain, standard clinical methods for evaluating analgesic efficacy are compromised and justify application of novel integrated approaches.Methods: We conducted two independent, multicenter, double-blind, placebo-controlled studies in men undergoing unilateral inguinal hernioplasty by open laparotomy to evaluate the safety and efficacy of XaraColl at different doses (100 mg and 200 mg of bupivacaine hydrochloride; study 1 and 2, respectively. Enrolled patients (50 in study 1 and 53 in study 2 were randomized to receive active or placebo implants in a 1:1 ratio. Postoperative pain intensity and use of supplementary opioid medication were recorded through 72 hours. Safety was assessed through 30 days. The principal efficacy variables were the summed pain intensity (SPI, total use of opioid analgesia (TOpA, and an integrated endpoint (I-SPI-TOpA. Each variable was analyzed at 24, 48, and 72 hours after implantation. A pooled analysis of both studies was also performed retrospectively.Results: Through 24 and 48 hours, XaraColl-treated patients experienced significantly less pain in study 1 (P < 0.001 and P = 0.012, respectively whereas they took significantly less opioid analgesia in study 2 (P = 0.004 and P = 0.042, respectively. Over the same time intervals in the pooled analysis, treated patients experienced

  16. A cohort evaluation of clinical use and performance characteristics of Ambu® AuraGain™: A prospective observational study

    Directory of Open Access Journals (Sweden)

    Devangi A Parikh

    2017-01-01

    Full Text Available Background and Aims: Ambu® AuraGain™ (AG (Ambu, Ballerup, Denmark is a supraglottic device which has a design facilitating its use as a conduit for intubation. We designed this prospective observational study to assess the ease of AG placement in paralysed patients, determine its position and alignment to the glottis and assess its utility as a conduit for intubation. Methods: One hundred patients, aged 18–60 years, American Society of Anesthesiologists physical status I–II, undergoing elective surgery under general anaesthesia were included in the study. The ease and number of attempts for successful insertion, ease of gastric tube insertion, leak pressures, fibre-optic grade of view, number of attempts and time for tracheal intubation, time for AG removal and complications were recorded. The mean, standard deviation (SD, interquartile range (IQR and range were calculated. The upper limit of confidence interval for overall failure rate was calculated using Wilson's score method. Results: AG was successfully inserted in all patients. The mean (SD time taken for insertion was 17.32 (8.48 s. The median [IQR] leak pressures were 24 [20–28] cm of H2O. Optimal laryngeal view for intubation was obtained in 68 patients. Eighty-eight patients could be intubated in the first attempt. Five patients could not be intubated. The overall failure rate of device was 9%. Conclusion: AMBU® AuraGain™ serves as an effective ventilating aid, but caution is suggested before using it as a conduit for endotracheal intubation.

  17. Clinical and radiographical evaluation of a bioresorbable collagen membrane of fish origin in the treatment of periodontal intrabony defects: A preliminary study.

    Science.gov (United States)

    Santosh Kumar, B B; Aruna, D R; Gowda, Vinayak S; Galagali, Sushama R; Prashanthy, R; Navaneetha, H

    2013-09-01

    Recently, there has been interest in non-mammalian collagen sources such as fish collagen in periodontal regeneration. In the present study, collagen barrier membrane of fish origin was assessed in the treatment of periodontal intrabony defects. Ten systemically healthy chronic periodontitis patients having a paired osseous defect in the mandibular posterior teeth were selected and randomly assigned to receive a collagen membrane (test) or open flap debridement (control) in a split mouth design. Clinical parameters such as Plaque index, Gingival bleeding index, Probing pocket depth, Relative attachment level, and Recession were recorded at baseline, 3, 6, and at 9 months, while radiographic evaluation was done to assess alveolar crestal bone level and percentage of defect fill at 6 and 9 months using autoCAD 2007 software. Student's t test (two-tailed, dependent) was used to find the significance of study parameters on continuous scale. Significance was set at 5% level of significance. Wilcoxon signed rank test was used to find the significance of percentage change of defect fill. The comparison between the two groups did not show any statistically significant differences in the parameters assessed (P > 0.05) but, within each group, clinical parameters showed statistically significant differences from baseline to 9 months (P < 0.05). Within the limits of the study, it can be inferred that no significant differences were found either by using collagen membrane of fish origin or open flap debridement in the treatment of periodontal intrabony defects.

  18. In vitro Comparative Evaluation of Various Restorative Materials used for restoring Class III Cavities in Deciduous Anterior Teeth: A Clinical Study.

    Science.gov (United States)

    Priyank, Harsh; Verma, Ankita; Gupta, Komal; Chaudhary, Esha; Khandelwal, Deepak; Nihalani, Shweta

    2016-12-01

    Beauty standards in today's modernized world scenario are formed by well-aligned and well-designed bright white teeth. One of the major reasons behind patients reporting to dental clinics is pain. Caries in the anterior primary teeth forms one of the major concerns from a restorative point of view. Very few studies are quoted in literature which stresses on the follow-up of anterior restorations in primary teeth. Hence, we evaluated and compared the efficacy of composite resin and resin-modified glass ionomer cement (RGIC) for class III restorations in primary anterior teeth. The present study was conducted in the pediatric dental wing and included a total of 80 patients aged 3 to 5½ years who reported with the chief complaint of carious lesions in the primary anterior teeth. Patients having minimal of a pair of similar appearing small carious lesions on the same proximal surfaces of the deciduous maxillary incisors were included for the study. All the patients were randomly divided into two groups: One in which RGIC restoration was done and other in which composite restoration was done. Cavity preparation was done and filling of the cavity with the restorative materials was carried out. Assessment of the restorations was done at 4, 8, and 12 months time following criteria given by Ryge et al. All the results were analyzed by Statistical Package for the Social Sciences (SPSS) software. Mann-Whitney test and one-way analysis of variance (ANOVA) were used to evaluate the level of significance; p value less than 0.05 was considered as significant. For composite and RGIC restorations, the mean score for anatomic shape was 1.21 and 1.10 respectively. While comparing the clinical parameters, nonsignificant results were obtained between composite and RGIC restorative materials at 4-, 8-, and 12-month interval. On comparing the clinical parameters for individual restorative materials at different time intervals, statistically significant results were obtained only for

  19. EVALUATION OF EFFICACY AND SAFETY POSTOPERATIVE PAIN MANAGEMENT BY INTRAMUSCULAR ANALGESIA AFTER DIFFERENT TYPES OF ANAESTHESIA: PILOT CLINICAL PROSPECTIVE STUDY.

    Science.gov (United States)

    Konkaev, A K; Eltaeva, A A; Zabolotskikh, I B; Musaeva, T S; Dibvik, L Z; Kuklin, V N

    2016-11-01

    Efficacy Safety Score (ESS) with "call-out algorithm" developed in Kongsberg hospital, Norway was used for the validation. ESS consists of the mathematical sum ofscorefrom: 2 subjective (Visual Analog Scale: VAS at rest and during mobilization) and 4 vital (conscious levels, PONV circulation and respiration status) parameters and ESS > 10 is a "call-out alarm "for visit ofpatient by anaesthesiologist. Hourly registration of ESS, mobility degree and amounts of analgetics during the first 8 hours after surgery was recorded in the specially designed IPad program. According to the type ofanaesthesia all patients were allocated in 4 groups: I spinal anaesthesia (SA), II general anesthesia (GA), III peripheral blockade (PB) and IV Total intravenous anaesthesia (TIVA). A total of 223 patients were included in the study. Statistically low levels of both VAS and ESS in the first 2-4 postoperative hours were found in SA and PB groups compared to GA and TIVA groups. During 8 post-operative hours, VAS> 3 was recorded in 10.5% of SA, 13.9% in GA, 12.8% in PG and 23.5% in TIVA patients. Intramuscular postoperative analgesia was effective in SA, GA and PG groups. More attention of anaesthesiologist must be paid to patients ofter TIVA.

  20. A prospective clinical study evaluating the development of bowel wall edema during laparoscopic and open visceral surgery.

    Science.gov (United States)

    Marjanovic, Goran; Kuvendziska, Jasmina; Holzner, Philipp Anton; Glatz, Torben; Sick, Olivia; Seifert, Gabriel; Kulemann, Birte; Küsters, Simon; Fink, Jodok; Timme, Sylvia; Hopt, Ulrich Theodor; Wellner, Ulrich; Keck, Tobias; Karcz, Wojciech Konrad

    2014-12-01

    To examine bowel wall edema development in laparoscopic and open major visceral surgery. In a prospective study, 47 consecutively operated patients with gastric and pancreatic resections were included. Twenty-seven patients were operated in a conventional open procedure (open group) and 20 in a laparoscopic fashion (lap group). In all procedures, a small jejunal segment was resected during standard preparation, of which we measured the dry-wet ratio. Furthermore, HE staining was performed for measuring of bowel wall thickness and edema assessment. Mean value (±std) of dry-wet ratio was significantly lower in the open than in the lap group (0.169 ± 0.017 versus 0.179 ± 0.015; p = 0.03) with the same amount of fluid administration in both groups and a longer infusion interval during laparoscopic surgery. Subgroup analyses (only pancreatic resections) still showed similar results. Histologic examination depicted a significantly larger bowel wall thickness in the open group. Laparoscopic surgery does not seem to lead to the bowel wall edema observed to occur in open surgery regardless of the degree of intravenous fluid administration, thus supporting its use even in major visceral surgery.

  1. Assessment of renal artery stenosis of transplanted kidney by time resolved gadolinium-enhanced three-dimensional MR angiography. Preliminary phantom study and clinical evaluation

    International Nuclear Information System (INIS)

    Hayano, Toshio

    2001-01-01

    The purpose of this study was to determine a suitable imaging parameters of time-resolved Gd-enhanced three-dimensional MR angiography (TRE3DMRA) for the evaluation of renal artery stenosis of transplanted kidneys and to investigate the usefulness of TRE3DMRA in 166 clinical cases. Source images were obtained 3dFLASH with zero-filling interpolation (turbo MRA) using Siemens Magneton 1.5T. Acrylate tubes with 6 mm inner diameter filled with diluted Gd-DTPA were used as special phantoms. In the tubes, 25%, 50%, and 75% stenosis were made for simulating arterial stenosis, respectively. According to our clinical experiences, we decided 10 seconds or less acquisition time to obtaining renal artery images without overlapping with renal veins. To determine slice thickness, the degrees of stenosis of the phantom images obtained 8-second acquisition time in variable slice thickness were independently interpreted with visual inspection by two experienced diagnostic radiologists. One hundred sixty-six patients underwent renal transplantation were evaluated clinically. Using a power injector, 0.1 mmol/kg Gd-DTPA was injected after the test scan with 1 ml Gd-DTPA for the determination of acquisition timing. MR images were obtained in the following imaging parameters; 4-mm slice thickness and 8-second acquisition time based on the results of phantom studies. Source images were noted in oblique coronal direction encompassing the entire renal arteries from iliac arteries to renal hili. Based on phantom study, slice thickness must be less than 4-mm to demonstrate the significant stenotic portion (>50%) of the phantom simulating transplanted renal artery. In 150 of 166 patients, excellent images of renal arteries were obtained without overlapping with renal veins. Causes of poor images were mainly inadequate timing of image acquisition. We can decide the imaging parameters of TRE3DMRA for the evaluation of renal artery stenosis of transplanted kidneys. Using these parameters, in 150

  2. Evaluation of C-reactive protein as a clinical biomarker in naturally heartworm-infected dogs: a field study.

    Science.gov (United States)

    Venco, Luigi; Bertazzolo, Walter; Giordano, Guglielmo; Paltrinieri, Saverio

    2014-11-15

    Canine heartworm disease caused by Dirofilaria immitis is considered a pulmonary disease, which leads to pulmonary hypertension, and in the late stage, may induce right cardiac insufficiency. Adult worms are localized in the pulmonary arteries, which undergo endothelial damage (proliferative endoarteritis), the severity of which depends on the duration of infection and the worm burden. C-reactive protein (CRP) is a major canine acute-phase protein that rapidly increases in a wide range of inflammatory conditions and rapidly decreases when inflammation resolves. CRP is therefore considered a sensitive but nonspecific marker of inflammation. Pulmonary arterial damage in canine heartworm may induce an increase in CRP concentrations similar to what occurs in humans with endoarteritis. The aim of the present study was to investigate whether CRP may be a diagnostic and/or prognostic marker in canine heartworm, whether it may be used for staging and monitoring canine heartworm, and whether its concentration depends on worm burden or on pulmonary arterial damage. Serum CRP concentrations were determined in 57 dogs with heartworm disease, 47 of which were grouped according to parasite burden (low: n=11; high: n=10) or on severity of pulmonary hypertension (mild: n=16; severe: n=10). An additional 23 heartworm-free cardiopathic dogs were grouped on the absence of pulmonary hypertension (n=8), presence of dilated cardiomyopathy (DCM) (n=6), or presence of cardiomyopathy and pulmonary hypertension (n=3) due to previous heartworm disease that had been treated (n=6). Twenty control dogs also were sampled for CRP concentrations. Results show that CRP was significantly increased (pcardiomyopathy compared with concentrations in controls. In the heartworm group, CRP was significantly increased (p29.8 mg/L). In conclusion, CRP can be used as a marker of endothelial arteritis and pulmonary hypertension in dogs with heartworm. Copyright © 2014 Elsevier B.V. All rights reserved.

  3. [Elaboration and critical evaluation of clinical guidelines].

    Science.gov (United States)

    García Villar, C

    2015-11-01

    Clinical guidelines are documents to help professionals and patients select the best diagnostic or therapeutic option. Elaborating guidelines requires an efficient literature search and a critical evaluation of the articles found to select the most appropriate ones. After that, the recommendations are formulated and then must be externally evaluated before they can be disseminated. Even when the guidelines are very thorough and rigorous, it is important to know whether they fulfill all the methodological requisites before applying them. With this aim, various scales have been developed to critically appraise guidelines. Of these, the AGREE II instrument is currently the most widely used. This article explains the main steps in elaborating clinical guidelines and the main aspects that should be analyzed to know whether the guidelines are well written. Copyright © 2015 SERAM. Published by Elsevier España, S.L.U. All rights reserved.

  4. Assessment of treatment response to splint therapy and evaluation of TMJ function using joint vibration analysis in patients exhibiting TMJ disc displacement with reduction: A clinical study

    Directory of Open Access Journals (Sweden)

    Jyoti Devi

    2017-01-01

    Full Text Available Context, Aim, and Objectives: Diagnosis of temporomandibular joint (TMJ disc displacement with reduction (DDR is difficult. Literature combining different subjective parameters of TMJ function with an objective evaluation of TMJ function using joint vibration analysis (JVA is limited. Hence, the study was planned to diagnose temporomandibular disorder accurately, to do a subjective and objective evaluation of TMJ function, and to assess the effectiveness of different types of splint therapy over the conventional anterior repositioning appliance (ARA group. Design: Single-blind, randomized, comparative clinical trial conducted in thirty patients, 18–55 years of age, allocated to three groups, i.e., ARA conventional group, centric stabilization splint (CSS, and Soft splint (SS groups. Subjects and Methods: Preoperative values of comfortable mouth opening (CMO in mm, maximum mouth opening (MMO in mm, TMJ clicking and tenderness (grading 0–3, visual analog scale pain score (0–10 cm, and total energy (TE integral values of both TMJs using JVA were recorded. Postoperative values were taken at the time of delivery of splint at 1st, 2nd, 6th, and 10th week. Statistical Analysis and Results: Intergroup comparison – Kruskal–Wallis test showed no statistically significant difference in CMO, MMO, and TE values of right TMJs among three groups at any point. No significant difference was seen in TMJ clicking and tenderness among groups at any point of time except at 10 weeks and at 2 weeks, respectively, by Chi-square test. Intragroup comparison - Wilcoxon signed-rank test showed the significance of difference (P < 0.05* in postoperative visits for CMO, MMO, pain score, and TE values. Clinical effect size, extent, consistency, and percentage of cases showing improvement were maximum for CSS group. Conclusions: The study concludes that the use of JVA for diagnosis along with history and clinical examination increases the accuracy of the diagnosis of

  5. Evaluating the Effect of a Web-Based E-Learning Tool for Health Professional Education on Clinical Vancomycin Use: Comparative Study.

    Science.gov (United States)

    Bond, Stuart Evan; Crowther, Shelley P; Adhikari, Suman; Chubaty, Adriana J; Yu, Ping; Borchard, Jay P; Boutlis, Craig Steven; Yeo, Wilfred Winston; Miyakis, Spiros

    2018-02-26

    Internet-based learning for health professional education is increasing. It offers advantages over traditional learning approaches, as it enables learning to be completed at a time convenient to the user and improves access where facilities are geographically disparate. We developed and implemented the Vancomycin Interactive (VI) e-learning tool to improve knowledge on the clinical use of the antibiotic vancomycin, which is commonly used for treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). The aims of this study were to evaluate the effect of the VI e-learning tool on (1) survey knowledge scores and (2) clinical use of vancomycin among health professionals. We conducted a comparative pre-post intervention study across the 14 hospitals of two health districts in New South Wales, Australia. A knowledge survey was completed by nurses, doctors, and pharmacists before and after release of a Web-based e-learning tool. Survey scores were compared with those obtained following traditional education in the form of an email intervention. Survey questions related to dosing, administration, and monitoring of vancomycin. Outcome measures were survey knowledge scores among the three health professional groups, vancomycin plasma trough levels, and vancomycin approvals recorded on a computerized clinical decision support system. Survey response rates were low at 26.87% (577/2147) preintervention and 8.24% (177/2147) postintervention. The VI was associated with an increase in knowledge scores (maximum score=5) among nurses (median 2, IQR 1-2 to median 2, IQR 1-3; Pe-learning tool achieved higher overall scores than those who did not (Pe-learning tool was not shown to be significantly more effective than the comparator email in the clinical use of vancomycin, as measured by plasma levels within the therapeutic range. The e-learning tool was associated with improved knowledge scores among nurses, whereas the comparator email was associated with

  6. Instructional scaffolding to improve students' skills in evaluating clinical literature.

    Science.gov (United States)

    Dawn, Stefani; Dominguez, Karen D; Troutman, William G; Bond, Rucha; Cone, Catherine

    2011-05-10

    To implement and assess the effectiveness of an activity to teach pharmacy students to critically evaluate clinical literature using instructional scaffolding and a Clinical Trial Evaluation Rubric. The literature evaluation activity centered on a single clinical research article and involved individual, small group, and large group instruction, with carefully structured, evidence-based scaffolds and support materials centered around 3 educational themes: (1) the reader's awareness of text organization, (2) contextual/background information and vocabulary, and (3) questioning, prompting, and self-monitoring (metacognition). Students initially read the article, scored it using the rubric, and wrote an evaluation. Students then worked individually using a worksheet to identify and define 4 to 5 vocabulary/concept knowledge gaps. They then worked in small groups and as a class to further improve their skills. Finally, they assessed the same article using the rubric and writing a second evaluation. Students' rubric scores for the article decreased significantly from a mean pre-activity score of 76.7% to a post-activity score of 61.7%, indicating that their skills in identifying weaknesses in the article's study design had improved. Use of instructional scaffolding in the form of vocabulary supports and the Clinical Trial Evaluation Rubric improved students' ability to critically evaluate a clinical study compared to lecture-based coursework alone.

  7. The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions.

    Science.gov (United States)

    Grube, Eberhard; Chevalier, Bernard; Smits, Peter; Džavík, Vladimir; Patel, Tejas M; Mullasari, Ajit S; Wöhrle, Jochen; Stuteville, Marrianne; Dorange, Cécile; Kaul, Upendra

    2011-02-01

    The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized

  8. Value of quantitative MRI parameters in predicting and evaluating clinical outcome in conservatively treated patients with chronic midportion Achilles tendinopathy: A prospective study.

    Science.gov (United States)

    Tsehaie, J; Poot, D H J; Oei, E H G; Verhaar, J A N; de Vos, R J

    2017-07-01

    To evaluate whether baseline MRI parameters provide prognostic value for clinical outcome, and to study correlation between MRI parameters and clinical outcome. Observational prospective cohort study. Patients with chronic midportion Achilles tendinopathy were included and performed a 16-week eccentric calf-muscle exercise program. Outcome measurements were the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire and MRI parameters at baseline and after 24 weeks. The following MRI parameters were assessed: tendon volume (Volume), tendon maximum cross-sectional area (CSA), tendon maximum anterior-posterior diameter (AP), and signal intensity (SI). Intra-class correlation coefficients (ICCs) and minimum detectable changes (MDCs) for each parameter were established in a reliability analysis. Twenty-five patients were included and complete follow-up was achieved in 20 patients. The average VISA-A scores increased significantly with 12.3 points (27.6%). The reliability was fair-good for all MRI-parameters with ICCs>0.50. Average tendon volume and CSA decreased significantly with 0.28cm 3 (5.2%) and 4.52mm 2 (4.6%) respectively. Other MRI parameters did not change significantly. None of the baseline MRI parameters were univariately associated with VISA-A change after 24 weeks. MRI SI increase over 24 weeks was positively correlated with the VISA-A score improvement (B=0.7, R 2 =0.490, p=0.02). Tendon volume and CSA decreased significantly after 24 weeks of conservative treatment. As these differences were within the MDC limits, they could be a result of a measurement error. Furthermore, MRI parameters at baseline did not predict the change in symptoms, and therefore have no added value in providing a prognosis in daily clinical practice. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  9. Histopathological and clinical evaluation of Kombucha tea and Nitrofurazone on cutaneous full-thickness wounds healing in rats: an experimental study.

    Science.gov (United States)

    Barati, Fardin; Javanbakht, Javad; Adib-Hashemi, Farajollah; Hosseini, Ehsan; Safaeie, Reyhaneh; Rajabian, Mojtaba; Razmjoo, Mostafa; Sedaghat, Reza; Aghamohammad Hassan, Mehdi

    2013-07-17

    Kombucha, a fermented tea (KT) is claimed to possess many beneficial properties. The aim of this study was to evaluate clinical and histopathological alterations of Kombucha tea and Nitrofurazone on cutaneous full-thickness wounds healing in rat. In present study 24 Wister -albino rats weighing 150-200 g were selected and divided to two treatment groups as Nitrofurazone ointment (0.2%) and Kombucha tea. Subsequently, the anesthesia was exerted by Ketamin hydrochloride 10% (40 mg/kg) and Xylasine (2 mg/kg) through intra muscular (IM) route. Furthermore, upon preparation of dorsal region of the animal for surgery, a piece of full-thickness skin removed (2 × 2 cm). In order to comparing wounds healing clinically and histologically, once every four days from the commencement, the wounds were photographed and the healed surface was measured by Scion image software. The clinical findings indicated that the Kombucha fungus resulted in precipitating healing than Nitrofurazone; however, it was not significant (p > 0.05). In order to pathological comparing of wound healing process, several wound biopsies were taken on 4, 8, 12, 16 and 20th days. Additionally, the histopathological results demonstrated that there was inflammation in Nitrofurazone group through twelveth day, somehow the epithelium was formed and abundant vessels were visible. Although on 16th day and the previous days the healing condition of Kombucha fungus was considered as minimal rate, revealing it is similar to Nitrofurazone group on 20th day. To wrap up. These observations suggest that the Kombucha fungus healing quality was rapid from 12th day to the end of the research, whereas no significant difference was observed. The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1107407136102196.

  10. Evaluation of pre-existing antibody presence as a risk factor for posttreatment anti-drug antibody induction: analysis of human clinical study data for multiple biotherapeutics.

    Science.gov (United States)

    Xue, Li; Rup, Bonita

    2013-07-01

    Biotherapeutic-reactive antibodies in treatment-naïve subjects (i.e., pre-existing antibodies) have been commonly detected during clinical immunogenicity assessments; however information on pre-existing antibody prevalence, physiological effects, and impact on posttreatment anti-drug antibody (ADA) induction remains limited. In this analysis, pre-existing antibody prevalence and impact on posttreatment ADA induction were determined using ADA data from 12 biotherapeutics analyzed in 32 clinical studies. Approximately half (58%) of the biotherapeutics were associated with some level of pre-existing antibodies and 67% of those were associated with posttreatment ADA induction. Across all studies, 5.6% of study subjects demonstrated presence of pre-existing antibodies, among which, 17% of the individual subjects had posttreatment increases in their ADA titers while 16% had decreased titers and 67% had no change in titers. However, in studies conducted in the rheumatoid arthritis (RA) population, 14.8% of RA patients were associated with pre-existing antibodies and 30% of those had posttreatment titer increases. The results suggest that in most study subjects, pre-existing antibodies pose a low risk for posttreatment ADA induction. That said, the high risk of induction implicated for RA patients, primarily observed in treatments evaluating novel antibody-based constructs, indicates that further understanding of the contribution of product and disease-specific factors is needed. Cross-industry efforts to collect and analyze a larger data set would enhance understanding of the prevalence, nature, and physiological consequences of pre-existing antibodies, better inform the immunogenicity risk profiles of products associated with these antibodies and lead to better fit-for-purpose immunogenicity management and mitigation strategies.

  11. Randomized clinical study for comparative evaluation of fourth-generation fluoroquinolones with the combination of fortified antibiotics in the treatment of bacterial corneal ulcers.

    Science.gov (United States)

    Shah, Vinit Mahendra; Tandon, Radhika; Satpathy, Gita; Nayak, Niranjan; Chawla, Bhavna; Agarwal, Tushar; Sharma, Namrata; Titiyal, Jeewan S; Vajpayee, Rasik B

    2010-07-01

    Comparative evaluation of efficacy of monotherapy with moxifloxacin (0.5%) or gatifloxacin (0.3%) with combination therapy of cefazolin (5%) and tobramycin (1.3%) in treatment of bacterial corneal ulcers. Patients diagnosed with bacterial keratitis (ulcer diameter 2-8 mm) were randomized to 1 of the 3 treatment groups (tobramycin 1.3% and cefazolin 5%, gatifloxacin 0.3%, or moxifloxacin 0.5%). After obtaining corneal scrapings, assigned study medication was instilled hourly for 48 hours and tapered as per clinical response. Healing of ulcer, duration to cure, adverse reactions, antibiogram profile, treatment failures, final visual acuity, and corneal opacity size were evaluated. A total of 61 patients were enrolled [cefazolin and tobramycin (n = 20), gatifloxacin (n = 21), and moxifloxacin (n = 20)]. Overall, 57 patients (93%) healed on treatment. On comparison of the mean time taken to heal, no statistically significant difference was found among all the 3 treatment groups (P = 0.98). Positive bacterial culture was obtained in only 38 patients (62%). There was no significant difference in the bacterial isolates in each treatment group. There were 4 (7%) treatment failures (perforation or nonhealing ulcer): 1 (5%) each in moxifloxacin and gatifloxacin group and 2 (10%) in fortified antibiotics group. All regimens were well tolerated. The study failed to find a difference in the efficacy of monotherapy with fourth-generation fluoroquinolones in the treatment of bacterial corneal ulcers of 2-8 mm size when compared with combination therapy of fortified antibiotics.

  12. Formulation, stability study, and pre-clinical evaluation of a vaginal cream containing curcumin in a rat model of vulvovaginal candidiasis.

    Science.gov (United States)

    de Souza Fernandes, Lígia; Amorim, Yuri Martins; Silva, Elton Libério da; Silva, Samuel Calixto; Santos, Alécia Junia Aparecida; Peixoto, Franciele Natália; Pires, Luara Moniele Neves; Sakamoto, Raquel Yumi; Pinto, Flávia do Carmo Horta; Scarpa, Maria Virgínia Costa; Gonzaga de Freitas Araújo, Marcelo

    2018-03-08

    Owing to the growing resistance among isolates of Candida species to usual antifungal agents and the well-known therapeutic potential of curcumin, the purpose of this study was to develop and validate a vaginal formulation containing this substance and to evaluating its effectiveness in the treatment of experimental vulvovaginal candidiasis METHODS: Curcumin was incorporated in a vaginal cream in three concentrations (0.01, 0.1 and 1.0%). The different concentrations of the cream and its controls were intravaginally administered in an immunosuppressed rat model to evaluate the efficacy in the treatment of experimental vulvovaginal candidiasis. Samples of the cream were also subjected to centrifugation and physical stability tests and an analytical method for quantification of curcumin was validated based on HPLC RESULTS: The formulation was stable and the HPLC method could be considered suitable for the quantitative determination of curcumin in the cream. After six days of pre-clinical study, the number of infected animals was 1/6 in all groups treated with curcumin vaginal cream and the fungal burden showed a progressive reduction. Reduction of the inflammatory infiltrate was observed in the group treated with 1.0% cream CONCLUSION: Vaginal cream containing curcumin could be considered a promising effective antifungal medicine in the treatment of vulvovaginal candidiasis. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  13. Evaluation of four designs of short implants placed in atrophic areas with reduced bone height: a three-year, retrospective, clinical and radiographic study.

    Science.gov (United States)

    Lopez Torres, J A; Gehrke, S A; Calvo Guirado, J L; Aristazábal, L F R

    2017-09-01

    The aim of the present study was to evaluate retrospectively the clinical and radiographic behaviour of four commercially-available short implants with different macrodesigns and microdesigns in areas in which the height of the bone was reduced. We took into account the success and survival, peri-implant crestal bone loss, and the level of probing at which the gum bled. Patients were included if they had been given one or more short implants (≤8.5mm long) in the posterior jaws at least three years earlier. Three hundred and ninety-one short implants were placed in 170 subjects, and were divided in four groups based on the brand of implant. The implants were evaluated one, two, and three years after they had been inserted. Short implants had a three-year survival and success rate of 90% in all groups, and bone loss was acceptable after three years with no significant differences between them. These results support the use of short implants as an effective and safe treatment. However, within the limitations of this study, the design of the implant does seem to influence the behaviour of peri-implant bone at the crestal level. Copyright © 2017. Published by Elsevier Ltd.

  14. Evaluation of acute bacterial rhino sinusitis in asthma patients based on clinical parameters and imaging studies, together with ear, nose and throat examination

    Energy Technology Data Exchange (ETDEWEB)

    Faure, Alecsandra Calil Moises; Santoro, Ilka Lopes; Lederman, Henrique Manoel; Fernandes, Ana Luisa Godoy [Federal University of Sao Paulo (UNIFESP/EPM), SP (Brazil). School of Medicine from Sao Paulo. Dept. of Internal Medicine]. E-mail: analgf@terra.com.br; analuisa@pneumo.epm.br; Weckx, Luc Louis Maurice [Federal University of Sao Paulo (UNIFESP/EPM), SP (Brazil). School of Medicine from Sao Paulo. Otorhinolaryngology; Fernandes, Artur da Rocha Correa [Federal University of Sao Paulo (UNIFESP/EPM), SP (Brazil). School of Medicine from Sao Paulo. Dept. of Diagnostic Imaging

    2008-06-15

    Objective: To evaluate paranasal sinuses in patients with stable or acute asthma in order to determine the prevalence of acute bacterial rhinosinusitis. Methods: A cross-sectional study including 30 patients with acute asthma (73% females) treated in the emergency room and 30 patients with stable asthma (80% females) regularly monitored as outpatients. All patients completed a questionnaire on respiratory signs and symptoms and were submitted to ear, nose and throat (ENT) examination, as well as to X-ray and computed tomography (CT) imaging of the sinuses. Results: Based on the clinical diagnosis, the prevalence of acute bacterial rhinosinusitis was 40% in the patients with acute asthma and 3% in those with stable asthma. The ENT examination findings and the imaging findings in isolation were not useful to confirm the diagnosis. Conclusions: In themselves, ENT examination findings, X-ray findings and CT findings were not useful for the diagnosis of acute bacterial rhinosinusitis. Our results provide further evidence that a clinical diagnosis of bacterial rhinosinusitis should be made with caution. (author)

  15. Development and evaluation of a holistic surgical head and neck cancer post-treatment follow-up clinic using touchscreen technology-Feasibility study.

    Science.gov (United States)

    Semple, C J; Lannon, D; Qudairat, E; McCaughan, E; McCormac, R

    2018-03-01

    The efficacy of traditional follow-up care is being challenged, as cancer survivors' supportive and psychological needs are often neither identified, nor addressed. This study's aim was to develop a holistic surgical follow-up clinic for oral and oropharyngeal cancer patients were participants completed a disease-specific health-related quality of life tool (UWQOLv4) and item prompt list (Patient Concern Inventory) on a touchscreen computer. Information generated was used to focus the consultation on patient's identified needs and concerns. By means of a prospective non-randomised, pre-test post-test design, this follow-up clinic was evaluated using the patient enablement instrument (PEI) and patient content checklist (PCC). Feasibility was explored from the patient perspective (satisfaction survey) and clinician perspective (qualitative interview). Forty-four consecutive patients were recruited. Findings demonstrating five of the eight topics (overall QOL, emotions, head and neck symptoms, side-effects of treatment, chronic non-specific) on PCC were discussed more frequently, but changes were not statistically significant. The PEI highlighted a trend towards perceived improvement in four of the six items. Using touchscreen computers to aid communication during routine follow-up was reported as both feasible and beneficial by patients and clinicians. Providing a patient-focused follow-up consultation can facilitate the identification of unmet needs, permitting timely and appropriate intervention being initiated. © 2018 John Wiley & Sons Ltd.

  16. Evaluation of acute bacterial rhino sinusitis in asthma patients based on clinical parameters and imaging studies, together with ear, nose and throat examination

    International Nuclear Information System (INIS)

    Faure, Alecsandra Calil Moises; Santoro, Ilka Lopes; Lederman, Henrique Manoel; Fernandes, Ana Luisa Godoy; Weckx, Luc Louis Maurice; Fernandes, Artur da Rocha Correa

    2008-01-01

    Objective: To evaluate paranasal sinuses in patients with stable or acute asthma in order to determine the prevalence of acute bacterial rhinosinusitis. Methods: A cross-sectional study including 30 patients with acute asthma (73% females) treated in the emergency room and 30 patients with stable asthma (80% females) regularly monitored as outpatients. All patients completed a questionnaire on respiratory signs and symptoms and were submitted to ear, nose and throat (ENT) examination, as well as to X-ray and computed tomography (CT) imaging of the sinuses. Results: Based on the clinical diagnosis, the prevalence of acute bacterial rhinosinusitis was 40% in the patients with acute asthma and 3% in those with stable asthma. The ENT examination findings and the imaging findings in isolation were not useful to confirm the diagnosis. Conclusions: In themselves, ENT examination findings, X-ray findings and CT findings were not useful for the diagnosis of acute bacterial rhinosinusitis. Our results provide further evidence that a clinical diagnosis of bacterial rhinosinusitis should be made with caution. (author)

  17. Experimental evaluation of clinical colon anastomotic leakage

    DEFF Research Database (Denmark)

    Pommergaard, Hans-Christian

    2014-01-01

    , whereas the eight-suture control anastomoses had a 0% leakage rate. Furthermore, the use of absorbable suture together with voluntarily ingested Temgesic in chocolate spread as analgesic regimen were feasible. This model may be used to test the leakage reducing potential of coating materials. STUDY 3...... experimental, in which designs were not comparable and many results were contradictory. In a clinical study, a non-significant benefit of fibrin sealant was found. Based on the available clinical and experimental data it was concluded that the fibrin-based sealants, such as Tisseel and Tachosil...

  18. Clinical and MRI evaluation of tuberculous meningitis

    International Nuclear Information System (INIS)

    Jiang Chunjing; Shu Jiner; Chen Jian; Sheng Sanlan; Lu Jinhua; Cai Xiaoxiao; Li Huimin

    2010-01-01

    Objective: To evaluate the relationship of clinical and magnetic resonance imaging (MRI) findings in patients with tuberculous meningitis (TBM), and to improve the understanding of TBM. Methods: The clinical and MRI findings in 42 patients with confirmed TBM were analyzed retrospectively. MRI examination was performed using a 1 Tesla system, including SE T 1 WI and T 2 WI. Intravenous contrast was injected in 29 patients, and follow-up scans were performed on 17 patients. Results: Of 24 patients with early TBM, MRI was abnormal in 5(21%) with slight Tl-hypointense meningeal (4) or ependymal thickening (1). MRI on 33/35 (94%) patients with late stage TBM was abnormal with T 1 hypointensity and T 2 hyperintensity including meningeal thickening (19), mild surrounding brain edema (10), nodules (11), tuberculoma (5) and abscess (2). There was significant plaque-like, nodular or rim enhancement with surrounding brain edema. Conclusion: Tuberculous meningitis has minimal clinical and MRI findings in the early phase and significant clinical and MRI findings in the late phase. The enhanced scan may help to detect the abnormality. (authors)

  19. A prospective, comparative, evaluator-blind clinical study investigating efficacy and safety of two injection techniques with Radiesse ® for the correction of skin changes in aging hands

    Directory of Open Access Journals (Sweden)

    Elena I Gubanova

    2015-01-01

    Full Text Available Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse ® . Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse ® (0.8 mL/0.2 mL 2% lidocaine was injected subdermally on Day (D01, using a needle multipoint technique in one hand (N and a fan-like cannula technique in the other (C. Assessments were made pre-injection, on D14, Month (M02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS and Global Aesthetic Improvement Scale (GAIS. Participants completed questionnaires on satisfaction, pain and adverse events (AEs. Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene′s tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse ® . Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction and 3 (optimal cosmetic result at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30. Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse ® .

  20. Evaluation of the safety and efficacy of pregabalin in older patients with neuropathic pain: results from a pooled analysis of 11 clinical studies

    Directory of Open Access Journals (Sweden)

    Zlateva Gergana

    2010-11-01

    Full Text Available Abstract Background Older patients are typically underrepresented in clinical trials of medications for chronic pain. A post hoc analysis of multiple clinical studies of pregabalin in patients with painful diabetic peripheral neuropathy (DPN or postherpetic neuralgia (PHN was conducted to evaluate the efficacy and safety of pregabalin in older patients. Methods Data from 11 double-blind, randomized, placebo-controlled clinical studies of pregabalin in patients with DPN or PHN were pooled. Efficacy outcomes included change in Daily Pain Rating Scale score, ≥30% and ≥50% responders, and endpoint pain score ≤3. Safety was based on adverse events (AEs. Primary efficacy was analyzed by analysis of covariance with terms for treatment, age category, protocol, baseline pain, and treatment-by-age category interaction. Results 2516 patients (white, n = 2344 [93.2%]; men, n = 1347 [53.5%]; PHN, n = 1003 [39.9%]; pregabalin, n = 1595 were included in the analysis. Patients were grouped by age: 18 to 64 years (n = 1236, 65 to 74 years (n = 766, and ≥75 years (n = 514. Baseline mean pain and sleep interference scores were comparable across treatment and age groups. Significant improvements in endpoint mean pain were observed for all pregabalin dosages versus placebo in all age groups (p ≤ 0.0009, except for the lowest dosage (150 mg/day in the youngest age group. Clinically meaningful pain relief, defined as ≥30% and ≥50% pain response, was observed in all age groups. The most common AEs were dizziness, somnolence, peripheral edema, asthenia, dry mouth, weight gain, and infections. The relative risks for these AEs increased with pregabalin dose, but did not appear related to older age or type of neuropathic pain. Conclusions Pregabalin (150-600 mg/day significantly reduced pain in older patients (age ≥65 years with neuropathic pain and improvements in pain were comparable to those observed in younger patients. Titration of pregabalin to the

  1. A pilot study to evaluate the role of the Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) in clinical decisions for pressure ulcer treatment.

    Science.gov (United States)

    Thomason, Susan S; Graves, Barbara Ann; Madaris, Linda

    2014-12-01

    The Spinal Cord Impairment Pressure Ulcer Monitoring Tool (SCI-PUMT) was designed to assess pressure ulcer (PrU) healing in the spinal cord impaired (SCI) population. The tool contains 7 variables: wound surface area, depth, edges, tunneling, undermining, exudate type, and necrotic tissue amount. A 2-phased, quantitative pilot study based on the Theory of Reasoned Action and Theory of Planned Behavior was conducted at a large SCI/Disorders Center in the Department of Veterans Affairs (VA). In the first phase of the study, a convenience sample of 5 physicians, 3 advanced practice registered nurses, and 3 certified wound care nurses (CWCN) was surveyed using a 2-part questionnaire to assess use of the SCI-PUMT instrument, its anticipated improvement in PrU assessment, and intent to use the SCI-PUMT in clinical practice. Attitudes, subjective norms, perceived behavioral controls, and barriers related to the intent to use the SCI-PUMT were evaluated using a 5-point Likert scale (range: 1= extremely likely, 5 = extremely unlikely). In the second phase of the study, the electronic health records (EHR) of 24 veterans (with 30 PrUs) who had at least 2 completed SCI-PUMT scores during a 4-week period were used to evaluate whether an association existed between magnitudes of change of total SCI-PUMT scores and ordered changes in PrU treatment. The overall mean score for intent to use SCI-PUMT was 1.80 (SD 0.75). The least favorable scores were for convenience and motivation to use the SCI-PUMT. Analysis of EHR data showed no significant difference in magnitudes of change in the SCI-PUMT score and changes in PrU treatment recommendations made by the CWCNs. The significance was not affected regardless of an increase or no change in the score (χ2 with 1 degree of freedom = 1.158, P = 0.282) or for a decrease in the score (χ2 with 1 degree of freedom = 0.5, P = 0.478). In this pilot study, the expressed intent to use the SCI-PUMT in making clinical decisions was generally

  2. Evaluation of anti-microbial activity of spore powder of Ganoderma lucidum on clinical isolates of Prevotella intermedia: A pilot study

    Directory of Open Access Journals (Sweden)

    Ranganath N Nayak

    2015-01-01

    Full Text Available Aim: This study aimed at evaluating the anti-microbial activity of spore powder of Ganoderma lucidum on Prevotella intermedia isolated from subgingival plaque from chronic periodontitis patients. Settings and Design: Written informed consent was obtained from each subject enrolled in the study. The Institutional Ethics Committee granted the ethical clearance for the study. Materials and Methods: This study included 20 patients diagnosed with chronic periodontitis. Pooled subgingival plaque samples were collected using sterile curettes from the deepest sites of periodontal pockets. The collected samples were then transported in 1 mL of reduced transport fluid. The organisms were cultured and confirmed. These organisms were then used for minimum inhibitory concentration (MIC procedure. Statistical Analysis: Mean of the MIC value obtained was calculated. Results: Thirteen out of the 20 clinical samples were tested that showed sensitivity at various concentrations. Five samples showed sensitivity at all concentrations. Twelve samples showed sensitivity at 8 mcg/ml. Eleven samples showed sensitivity at 4 mcg/ml, 8 samples showed sensitivity at 2 mcg/ml, and 5 samples showed sensitivity even at 1 mcg/ml. Mean MIC value of G. lucidum spore powder for P. intermedia obtained was 3.62 mcg/ml. Conclusion: G. lucidum with its multipotential bioactivity could be used as an anti-microbial, in conjunction with conventional therapy in periodontal disease.

  3. Atomic force microscopy and scanning electron microscopy evaluation of efficacy of scaling and root planing using magnification: A randomized controlled clinical study

    Directory of Open Access Journals (Sweden)

    Ranjana Mohan

    2013-01-01

    Full Text Available Aim: A randomized controlled clinical study was undertaken to evaluate the effectiveness of scaling and root planing (SRP by using Magnifying Loupes (ML and dental operating microscope (DOM. Materials and Methods: A total of 90 human teeth scheduled for extraction from 18 patients aged between 25 and 65 years suffering from generalized chronic severe periodontitis were randomly assigned to three treatment groups. Group 1 consisted SRP performed without using magnification (unaided, Group 2-SRP with ML and Group 3-SRP with DOM. Following extractions, samples were prepared for (i evaluation of surface topography by atomic force microscopy, (ii presence of smear layer, debris by scanning electron microscopy (iii elemental analysis by energy dispersive X-ray analysis. Data was subjected to statistical analysis using analysis of variance, post-hoc (Tukey-HSD and Chi-square test. Results: Statistically significant (P < 0.001 difference was found among the different treatment groups. Group 3 was the best while Group 1 was the least effective technique for SRP. Order of efficacy in terms of the surface was found to be - Palatal < Lingual < Distal ≅ Mesial < Buccal. Efficiency in mandibular to maxillary teeth was found to be significant (P < 0.05, also anterior to posterior teeth (P < 0.05. Conclusion: Magnification tools significantly enhance the efficacy of supragingival and subgingival SRP.

  4. Comparative evaluation of the effectiveness of electronic dental anesthesia with 2% lignocaine in various minor pediatric dental procedures: A clinical study

    Directory of Open Access Journals (Sweden)

    Abhishek Dhindsa

    2011-01-01

    Full Text Available One of the most distressing aspects of dentistry for pediatric patients is the fear and anxiety caused by the dental environment, particularly the dental injection. The application and induction of local anesthetics has always been a difficult task, and this demands an alternative method that is convenient and effective. Electronic dental anesthesia, based on the principal of transcutaneous electric nerve stimulation (TENS, promises to be a viable mode of pain control during various pediatric clinical procedures. Therefore, the aim of the present study was to evaluate the effectiveness of TENS and to compare its efficacy with 2% lignocaine during various minor pediatric dental procedures. Pain, comfort and effectiveness of both the anesthetics were evaluated using various scales and no significant difference was observed between 2% lignocaine and TENS in the various pain scales, while TENS was perceived to be significantly effective in comfort and efficacy as judged by the operator and quite comfortable as judged by the patient himself/herself.

  5. Evaluation of the liver scintigraphy with /sup 99m/Tc-Sn-colloid. II. C Clinical studies by comparison with /sup 198/Au-colloid

    Energy Technology Data Exchange (ETDEWEB)

    Kimura, K; Nishimura, T; Takeda, H; Furukawa, T [Osaka Univ. (Japan). Faculty of Medicine; Kajiya, Fumihiko

    1975-08-01

    Clinical significance of the liver scintigraphy with sup(99m)Tc-Sn-colloid was evaluated in comparison with those with /sup 198/Au-colloid. The liver scintigrams with sup(99m)Tc-Sn-colloid and /sup 198/Au-colloid were done in 36 cases of various hepatic diseases and RI accumulation curves in the liver and the spleen, and the blood disapearance curves were also obtained. The conclusions were as follows. The liver scintigrams with sup(99m)Tc-Sn-colloid proved to be more sensitive in the detection of tumors, especially, in the lower margin, left lobe and superficial layers of the liver than those with /sup 198/Au-colloid. In all cases, including normal and cirrhotic subjects, visualizations of the spleen were seen on the scintigrams with sup(99m)Tc-Sn-colloid. In diffuse hepatic diseases, comparing both radiopharmaceuticals, the splenic accumulations were studied qualitatively and quantitatively. As a result, the ratio (spleen/liver) was thought to be useful for the differentiation of diffuse hepatic diseases concerned with splenic function and/or size. It was also shown that sup(99m)Tc-Sn-colloid was useful as a spleen scanning agent. The Tl/2 in the liver accumulation curves with sup(99m)Tc-Sn-colloid were not as clearly differentiated in the various hepatic diseases as those with /sup 198/Au-colloid where those indexes were useful in the evaluation of liver functions.

  6. Two-Dimensional Cutting (TDC Vitrectome: In Vitro Flow Assessment and Prospective Clinical Study Evaluating Core Vitrectomy Efficiency versus Standard Vitrectome

    Directory of Open Access Journals (Sweden)

    Mitrofanis Pavlidis

    2016-01-01

    Full Text Available Purpose. To evaluate comparative aspiration flow performance and also vitrectomy operating time efficiency using a double-cutting open port vitreous cutting system incorporated in a two-dimensional cutting (TDC, DORC International vitrectome design versus standard vitreous cutter. Methods. In vitro investigations compared aspiration flow rates in artificial vitreous humor at varying cutter speeds and vacuum levels using a TDC vitrectome and a standard vitrectome across different aspiration pump systems. A prospective single-centre clinical study evaluated duration of core vitrectomy in 80 patients with macular pucker undergoing 25-gauge or 27-gauge vitrectomy using either a TDC vitrectome at 16,000 cuts per minute (cpm or standard single-cut vitrectome, combined with a Valve Timing intelligence (VTi pump system (EVA, DORC International. Results. Aspiration flow rates remained constant independent of TDC vitrectome cut rate, while flow rates decreased linearly at higher cutter speeds using a classic single-blade vitrectome. Mean duration of core vitrectomy surgeries using a TDC vitreous cutter system was significantly (p<0.001 shorter than the mean duration of core vitrectomy procedures using a single-cut vitrectome of the same diameter (reduction range, 34%–50%. Conclusion. Vitrectomy surgery performed using a TDC vitrectome was faster than core vitrectomy utilizing a standard single-action vitrectome at similar cut speeds.

  7. Clinical evaluation of the effect of gingival thickness on increasing the width of keratinized and attached gingiva with and without preserving periosteum in an animal study

    Directory of Open Access Journals (Sweden)

    Saeedeh Ebrahimi

    2017-07-01

    Full Text Available BACKGROUND AND AIM: The present study was performed in order to assess the effect of gingival thickness on amount of gingival augmentation with and without preserving periosteum. METHODS: The study was conducted on 8 ecotype dogs aged 1-5 years. At the beginning, clinical probing depth and keratinized and attached gingiva width were measured. Totally, 64 sites were operated in this study. Periosteal fenestration and denuded beds were randomly created on opposite sides of upper and lower jaws (4 sites each side. The thickness of gingiva was measured in mucogingival junction after preparation of the beds. The clinical parameters were evaluated 2 months after the surgery. The data were analyzed by Mann-Whitney U, Wilcoxon, and Pearson correlation tests. RESULTS: The results showed the average increased width of keratinized and attached gingiva was 1.8 mm and 2 mm in periosteal fenestration sites and 1.9 mm and 2.3 mm in denudation sites, respectively at 2 months post-surgery. The difference between the width of keratinized gingiva and attached gingiva before and 2 months after operation was significant in both groups (P < 0.001. However, no significant difference was shown between the two groups in terms of attached and keratinized gingival width (P = 0.100 and P = 0.720, respectively. There was no correlation between the thickness of gingiva and the amount of increased width of keratinized and attached gingiva. CONCLUSION: A gingival thickness of 0.8 to 2 mm does not affect the increment of the attached and keratinized gingival width with and without preserving periosteum.

  8. To evaluate disparity between clinical and pathological tumor-node-metastasis staging in oral cavity squamous cell carcinoma patients and its impact on overall survival: An institutional study

    Directory of Open Access Journals (Sweden)

    Karan Gupta

    2015-01-01

    Full Text Available Background: Accurate clinical staging is important for patient counseling, treatment planning, prognostication, and rational design of clinical trials. In head and neck squamous cell carcinoma, discrepancy between clinical and pathological staging has been reported. Objective: To evaluate any disparity between clinical and pathological tumor-node-metastasis (TNM staging in oral cavity squamous cell carcinoma (OCSCC patients and any impact of the same on survival. Materials and Methods: Retrospective chart review from year 2007 to 2013, at a tertiary care center. Statistical Analysis: All survival analyses were performed using SPSS for Windows version 15 (Chicago, IL, USA. Disease-free survival curves were generated using Kaplan-Meier algorithm. Results: One hundred and twenty-seven patients with OCSCC were analyzed. Seventy-nine (62.2% were males and 48 (37.8% females with a mean age at presentation 43.6 years (29-79 years. The highest congruence between clinical and pathological T-staging seen for clinical stage T1 and T4 at 76.9% and 73.4% with pathological T-stage. Similarly, the highest congruence between clinical and pathological N-stage seen for clinical N0 and N3 at 86.4% and 91.7% with pathological N-stage. Of clinically early stage patients, 67.5% remained early stage, and 32.5% were upstaged to advanced stage following pathological analysis. Of the clinically advanced stage patients, 75% remained advanced, and 25% were pathologically downstaged. This staging discrepancy did not significantly alter the survival. Conclusion: Some disparity exists in clinical and pathological TNM staging of OCSCC, which could affect treatment planning and survival of patients. Hence, more unified and even system of staging for the disease is required for proper decision-making.

  9. To evaluate disparity between clinical and pathological tumor-node-metastasis staging in oral cavity squamous cell carcinoma patients and its impact on overall survival: An institutional study.

    Science.gov (United States)

    Gupta, Karan; Panda, Naresh K; Bakshi, Jaimanti; Das, Ashim

    2015-01-01

    Accurate clinical staging is important for patient counseling, treatment planning, prognostication, and rational design of clinical trials. In head and neck squamous cell carcinoma, discrepancy between clinical and pathological staging has been reported. To evaluate any disparity between clinical and pathological tumor-node-metastasis (TNM) staging in oral cavity squamous cell carcinoma (OCSCC) patients and any impact of the same on survival. Retrospective chart review from year 2007 to 2013, at a tertiary care center. All survival analyses were performed using SPSS for Windows version 15 (Chicago, IL, USA). Disease-free survival curves were generated using Kaplan-Meier algorithm. One hundred and twenty-seven patients with OCSCC were analyzed. Seventy-nine (62.2%) were males and 48 (37.8%) females with a mean age at presentation 43.6 years (29-79 years). The highest congruence between clinical and pathological T-staging seen for clinical stage T1 and T4 at 76.9% and 73.4% with pathological T-stage. Similarly, the highest congruence between clinical and pathological N-stage seen for clinical N0 and N3 at 86.4% and 91.7% with pathological N-stage. Of clinically early stage patients, 67.5% remained early stage, and 32.5% were upstaged to advanced stage following pathological analysis. Of the clinically advanced stage patients, 75% remained advanced, and 25% were pathologically downstaged. This staging discrepancy did not significantly alter the survival. Some disparity exists in clinical and pathological TNM staging of OCSCC, which could affect treatment planning and survival of patients. Hence, more unified and even system of staging for the disease is required for proper decision-making.

  10. EVALUATION OF METABOLIC SYNDROME, ITS CORRELATION WITH CLINICAL AND ANGIOGRAPHIC PROFILE IN PATIENTS WITH CORONARY ARTERY DISEASE- A PROSPECTIVE STUDY AT TERTIARY HOSPITAL

    Directory of Open Access Journals (Sweden)

    Eruvaram Srikanth

    2016-10-01

    Full Text Available BACKGROUND Coronary artery disease has a major share for cardiovascular disease in a developing country like India, which is in epidemic proportion. There are number of risk factors for development of coronary artery disease. According to INTERHEART study, there were 9 modifiable risk factors with population attributable risk of 90 percent in men and 94 percent in women. Metabolic syndrome cluster of risk factors, which include insulin resistance, subclinical inflammation, increased future risk of diabetes and coronary artery disease. In south Asian people are increased tendency to develop metabolic syndrome because of their high percentage of body fat, abdominal obesity and insulin resistance. Metabolic syndrome has more mortality and morbidity from CAD. It is desirable identifying this subset of patients, which could improve patient or physician adherence to risk-reducing behaviours or interventions and improve clinical outcomes. There are reports in literature on association inflammatory markers and insulin resistance with severity of disease in CAD. There are few studies, which correlated severity of CAD with SYNTAX score in patients with metabolic syndrome, so in these study prospectively evaluated clinical and angiographic profile in patients with CAD in subset patients with metabolic syndrome, CAD severity was assessed with SYNTAX scoring system and thrombus burden was evaluated. MATERIALS AND METHODS Among 101 patients who were diagnosed to have metabolic syndrome according to ATP III guidelines were evaluated in the study. All patients were evaluated by clinical examination including waist circumference, body mass index, routine blood investigations were carried out. Lipid profile, ECG and 2D echo was done. Then, patients were evaluated with coronary angiogram and among patients who underwent coronary angiography, the lesions were classified according to AHA/ACC classification into type A, type B and type C for assessing lesion

  11. Clinical presentation and evaluation of dermatomyositis

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    Umaima Marvi

    2012-01-01

    Full Text Available Dermatomyositis (DM is a chronic inflammatory disorder of the skin and muscles. Evidence supports that DM is an immune-mediated disease and 50-70% of patients have circulating myositis-specific auto-antibodies. Gene expression microarrays have demonstrated upregulation of interferon signaling in the muscle, blood, and skin of DM patients. Patients with classic DM typically present with symmetric, proximal muscle weakness, and skin lesions that demonstrate interface dermatitis on histopathology. Evaluation for muscle inflammation can include muscle enzymes, electromyogram, magnetic resonance imaging, and/or muscle biopsy. Classic skin manifestations of DM include the heliotrope rash, Gottron′s papules, Gottron′s sign, the V-sign, and shawl sign. Additional cutaneous lesions frequently observed in DM patients include periungual telangiectasias, cuticular overgrowth, "mechanic′s hands", palmar papules overlying joint creases, poikiloderma, and calcinosis. Clinically amyopathic DM is a term used to describe patients who have classic cutaneous manifestations for more than 6 months, but no muscle weakness or elevation in muscle enzymes. Interstitial lung disease can affect 35-40% of patients with inflammatory myopathies and is often associated with the presence of an antisynthetase antibody. Other clinical manifestations that can occur in patients with DM include dysphagia, dysphonia, myalgias, Raynaud phenomenon, fevers, weight loss, fatigue, and a nonerosive inflammatory polyarthritis. Patients with DM have a three to eight times increased risk for developing an associated malignancy compared with the general population, and therefore all patients with DM should be evaluated at the time of diagnosis for the presence of an associated malignancy. This review summarizes the immunopathogenesis, clinical manifestations, and evaluation of patients with DM.

  12. Comparative evaluation of diffusion hypoxia and psychomotor skills with or without postsedation oxygenation following administration of nitrous oxide in children undergoing dental procedures: A clinical study

    Directory of Open Access Journals (Sweden)

    Vineet Inder Singh Khinda

    2016-01-01

    Full Text Available Background: Diffusion hypoxia is the most serious potential complication associated with nitrous oxide. It occurs during the recovery period. Hence, administration of 100% oxygen is mandatory as suggested by many authors. Aim: The aim of this study is to evaluate the occurrence/nonoccurrence of diffusion hypoxia in two groups of patients undergoing routine dental treatment under nitrous oxide sedation when one group is subjected to 7 min of postsedation oxygenation and the second group of the patients is made to breathe room air for the similar period. Materials and Methods: A total of sixty patients within the age group of 7–10 years requiring invasive dental procedures were randomly divided into two groups of 30 each using chit method. In the control group, patients were administered 100% oxygen postsedation, whereas, in the study group, patients were made to breathe room air postsedation. Various parameters (pulse rate, respiratory rate, blood pressure, and oxygen saturation [SpO2] were recorded pre- and post-operatively. Data were collected and then sent for statistical analysis. Results: The mean postoperative SpO2 at measurement times 1, 3, 5, and 7 min in both the groups was higher than the mean preoperative SpO2. This increase was statistically significant. No significant difference was found between the Trieger test scores. Conclusion: This study proves that clinical occurrence of diffusion hypoxia is not possible while following the routine procedure of nitrous oxide sedation.

  13. Comparative evaluation of diffusion hypoxia and psychomotor skills with or without postsedation oxygenation following administration of nitrous oxide in children undergoing dental procedures: A clinical study.

    Science.gov (United States)

    Khinda, Vineet Inder Singh; Bhuria, Parvesh; Khinda, Paramjit; Kallar, Shiminder; Brar, Gurlal Singh

    2016-01-01

    Diffusion hypoxia is the most serious potential complication associated with nitrous oxide. It occurs during the recovery period. Hence, administration of 100% oxygen is mandatory as suggested by many authors. The aim of this study is to evaluate the occurrence/nonoccurrence of diffusion hypoxia in two groups of patients undergoing routine dental treatment under nitrous oxide sedation when one group is subjected to 7 min of postsedation oxygenation and the second group of the patients is made to breathe room air for the similar period. A total of sixty patients within the age group of 7-10 years requiring invasive dental procedures were randomly divided into two groups of 30 each using chit method. In the control group, patients were administered 100% oxygen postsedation, whereas, in the study group, patients were made to breathe room air postsedation. Various parameters (pulse rate, respiratory rate, blood pressure, and oxygen saturation [SpO2]) were recorded pre- and post-operatively. Data were collected and then sent for statistical analysis. The mean postoperative SpO2 at measurement times 1, 3, 5, and 7 min in both the groups was higher than the mean preoperative SpO2. This increase was statistically significant. No significant difference was found between the Trieger test scores. This study proves that clinical occurrence of diffusion hypoxia is not possible while following the routine procedure of nitrous oxide sedation.

  14. Evaluating clinical research: all that glitters is not gold

    National Research Council Canada - National Science Library

    Furberg, Curt; Furberg, Bengt

    2007-01-01

    ...? Why is blinding/masking so important? How is symptomatic improvement measured? Is it really possible to assess quality of life? What is the value of biologic markers in drug evaluation? How are adverse drug reactions measured? How representative are study subjects in clinical trials? What happened to the study subjects who disappeared from the...

  15. Clinical evaluation of embolization of the superior vesical prostatic artery for treatment of benign prostatic hyperplasia: a single-center retrospective study.

    Science.gov (United States)

    Qiu, Zhilei; Zhang, Changcun; Wang, Xinsheng; Cheng, Kai; Liang, Xin; Wang, Dawen; Hou, Sichuan; Wang, Xinsheng

    2017-12-01

    Non-surgical minimally invasive treatments are greatly needed for patients with symptomatic benign prostatic hyperplasia (BPH), for whom medical treatment has failed and surgery is contraindicated. This study retrospectively evaluated the efficacy and safety of super-selective prostatic artery embolization (PAE) for BPH, relative to transurethral resection of the prostate (TURP). To clinically evaluate the efficacy and safety of super-selective PAE for BPH, relative to TURP. From February 2012 to March 2015, patients with BPH underwent selective PAE (n = 17) or TURP (control group; n = 40). Prostate volume, maximum urinary flow rate (Qmax), International Prostate Symptoms Score (IPSS), and quality of life (QoL) score were evaluated at baseline and postoperative 3, 6, and 12 months. Complications were also recorded. All the procedures were technically successfully. At postoperative 1 year, patients given PAE had significantly greater prostate volume (64.6 ±10.2 ml), IPSS (23.9 ±4.9), and QoL (4.1 ±0.7) compared with the control patients (42.0 ±7.5 ml, 13.1 ±3.5, and 2.1 ±0.7, respectively). The Qmax of the PAE group (9.5 ±3.7 ml/s) was significantly lower than that of the control (21.8 ±4.2 ml/s). The changes in parameters of the TURP patients relative to the preoperative baseline were significantly greater than those of the PAE group. No severe complications occurred. Prostatic artery embolization was demonstrated as safe and effective and may be considered an alternative treatment for BPH patients, especially for those who are not candidates for or refuse surgery.

  16. Dental health between self-perception, clinical evaluation and body image dissatisfaction - a cross-sectional study in mixed dentition pre-pubertal children.

    Science.gov (United States)

    Banu, Ancuta; Șerban, Costela; Pricop, Marius; Urechescu, Horatiu; Vlaicu, Brigitha

    2018-05-03

    Self-perception of oral health status is a multidimensional construct that includes psychological, psychosocial and functional aspects of oral health. Contemporary concepts suggest that the evaluation of health needs should focus on clinical standards and socio-dental indicators that measure the impact of health/disease on the individual quality of life. Oral health cannot be dissociated from general health. This study evaluates a possible association between oral health status, body size, self-perception of oral health, self-perception of body size and dissatisfaction with body image in prepubertal children with mixed dentition, targeting the completion of children's health status assessment which will further allow the identification of individuals at risk and could be further used as an evaluation of the need for specific interventions. The present study is cross-sectional in design and uses data from 710 pre-pubertal children with mixed dentition. The outcome variables comprised one item self-perception of oral health: dmft/DMFT Index and Dental Aesthetic Index, body size, self-assessed body size and desired body size. Multiple logistic regression analyses were performed. The level of significance was set at 5%. More than a half (53.1%) of the participants with mixed dentition reported that their oral health was excellent or very good. In the unadjusted model, untreated decayed teeth, dmft score and body dissatisfaction levels had a significant contribution to poor self-perception of oral health, but after adjustment for gender, BMI status, dmft score, DMFT score and DAI score, only untreated decayed teeth OR = 1.293, 95%CI (1.120-1.492) and higher body dissatisfaction levels had a significant contribution. It was concluded that the need for dental treatment influenced self-perception of oral health in prepubertal children with mixed dentition, especially with relation to untreated decayed teeth. Since only body dissatisfaction levels, but not BMI, were

  17. Evaluating the impact of a quality management intervention on post-abortion contraceptive uptake in private sector clinics in western Kenya: a pre- and post-intervention study.

    Science.gov (United States)

    Wendot, Susy; Scott, Rachel H; Nafula, Inviolata; Theuri, Isaac; Ikiugu, Edward; Footman, Katharine

    2018-01-19

    Integration of family planning counselling and method provision into safe abortion services is a key component of quality abortion care. Numerous barriers to post-abortion family planning (PAFP) uptake exist. This study aimed to evaluate the effect of a quality management intervention for providers on PAFP uptake. We conducted a pre- and post-intervention study between November 2015 and July 2016 in nine private clinics in Western Kenya. We collected baseline and post-intervention data using in-person interviews on the day of procedure, and follow-up telephone interviews to measure contraceptive uptake in the 2 weeks following abortion. We also conducted semi-structured interviews with providers. The intervention comprised a 1-day orientation, a counselling job-aide, and enhanced supervision visits. The primary outcome was the proportion of clients receiving any method of PAFP (excluding condoms) within 14 days of obtaining an abortion. Secondary outcomes were the proportion of clients receiving PAFP counselling, and the proportion of clients receiving long-acting reversible contraception (LARC) within 14 days of the service. We used chi-squared tests and multivariate logistic regression to determine whether there were significant differences between baseline and post-intervention, adjusting for potential confounding factors and clustering at the clinic level. Interviews were completed with 769 women, and 54% (414 women) completed a follow-up telephone interview. Reported quality of counselling and satisfaction with services increased between baseline and post-intervention. Same-day uptake of PAFP was higher at post-intervention compared to baseline (aOR 1.94, p quality of their services. A quality management intervention was successful in improving the quality of PAFP counselling and provision. Uptake of same-day PAFP, including LARC, increased, but there was no increase in overall uptake of PAFP 2 weeks after the abortion.

  18. Clinical utility of new bleeding criteria: a prospective study of evaluation for the Bleeding Academic Research Consortium definition of bleeding in patients undergoing percutaneous coronary intervention.

    Science.gov (United States)

    Choi, Jae-Hyuk; Seo, Jeong-Min; Lee, Dong Hyun; Park, Kyungil; Kim, Young-Dae

    2015-04-01

    The aim of this study was to evaluate the clinical utility of the new bleeding criteria, proposed by the Bleeding Academic Research Consortium (BARC), compared with the old criteria for determining the action of physicians in contact with bleeding events, after percutaneous coronary intervention (PCI). The BARC criteria were independently associated with an increased risk of 1-year mortality after PCI, and provided a predictive value, in regard to 1-year mortality. The standardized bleeding definitions will be expected to help the physician to correctly analyze the bleeding events, to select an optimal treatment, and to objectively compare the results of multiple trials and registries. All the patients undergoing PCI from June to September 2012 were prospectively enrolled. Patients who experienced a bleeding event were further classified, based on three different bleeding severity criteria: BARC, Thrombolysis In Myocardial Infarction (TIMI), and Global Use of Strategies To Open coronary arteries (GUSTO). The primary outcome was the occurrence of bleeding events requiring interruption of antiplatelet therapy (IAT) by physicians. A total of 376 consecutive patients were included in this study. Total bleeding events occurred in 46 patients (12.2%). BARC type ≥2 bleeding occurred in 30 patients (8.0%); however, TIMI major or minor bleeding, and GUSTO moderate or severe bleeding occurred in 6 (1.6%) and 11 patients (2.9%), respectively. Of the 46 patients, 28 (60.9% of patients) required IAT. On receiver-operating characteristic curve analysis, bleeding defined BARC type ≥2 effectively predicted IAT, with a sensitivity of 89.3%, and a specificity of 98.5% (pdefinition may be a more useful tool for the detection of bleeding with clinical relevance, for patients undergoing PCI. Copyright © 2014 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  19. Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human?Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans-

    OpenAIRE

    Goda, Keisuke; Kobayashi, Akio; Takahashi, Akemi; Takahashi, Tadakazu; Saito, Kosuke; Maekawa, Keiko; Saito, Yoshiro; Sugai, Shoichiro

    2017-01-01

    In the development of drugs, we sometimes encounter fatty change of the hepatocytes (steatosis) which is not accompanied by degenerative change in the liver in non-clinical toxicity studies. In this study, we investigated the relationships between fatty change of the hepatocytes noted in non-clinical toxicity studies of compound X, a candidate compound in drug development, and mitochondrial dysfunction in order to estimate the potential risk of the compound to induce drug-induced liver injury...

  20. Clinical image quality evaluation for panoramic radiography in Korean dental clinics

    International Nuclear Information System (INIS)

    Choi, Bo Ram; Choi, Da Hye; Huh, Kyung Hoe; Yi, Won Jin; Heo, Min Suk; Choi, Soon Chul; Bae, Kwang Hak; Lee, Sam Sun

    2012-01-01

    The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively.

  1. Clinical evaluation of 413 Thalassemic patients

    Directory of Open Access Journals (Sweden)

    Korosdari Gh.H

    2000-08-01

    Full Text Available Thalassemia is the most prevalent genetic disorder in Iran and around the world and these patients need regular careful care. The present study reports results of routine examination of patients visited Thalassemia clinic of Tehran. Data about clinical and laboratory examinations of 413 Thalassemic were extracted and analyzed. The prevalence of heart complications, diabetes, growth retardation, delayed puberty and primary and secondary amenorrhea was 9%, 8%, 21.3%, 3.1% and 6.3%, respectively. 44% didn't have secondary sex characteristics. Splenectomy had been done for 67.2% of cases. HBsAg, HBsAb and HBcAb were positive in 1.9%, 57.4% and 43%, respectively. We concluded that blood transfusion standards in this clinic was acceptable, whereas because of poor knowledge, iron chelating is unfavorable.

  2. Clinical and radiographic evaluation of effect of risedronate 5 mg as an adjunct to treatment of chronic periodontitis in postmenopausal women (12-month study).

    Science.gov (United States)

    Bhavsar, N V; Trivedi, S R; Dulani, K; Brahmbhatt, N; Shah, S; Chaudhri, D

    2016-08-01

    Bisphosphonates are beneficial to women, after menopause, in treatment of gum diseases. In this study, significant improvement in the disease condition was found and that no further progress was noted, and no side effects were reported. Bisphosphonates can be safely and successfully be used to support oral health procedures. The purpose of this study was to evaluate host modulating effect of bisphosphonate adjunct with the treatment of chronic periodontitis in osteopenic and osteoporotic postmenopausal women. Twenty-two osteopenic and osteoporotic postmenopausal women with moderate to severe chronic periodontitis were selected for the study. On intraoral examination, periodontal parameters like probing depth (PD), clinical attachment level (CAL), Plaque Index (PI) and Gingival Index (GI) were recorded. Scaling and root planing were done. Intraoral periapical X-rays were taken, and alveolar bone density (ABD) was measured with cone beam computed tomography (CBCT), and then, medications (risedronate 5 mg once daily (OD), calcium citrate 250 mg OD, vitamin D 400 IU OD) were given. Patients were recalled for follow-up at 3, 6 and 12 months. Intraoral periapical (IOPA) X-rays were taken at 6 and 12 months and ABD was measured at baseline and 12 months. There was a significant improvement in all the parameters. There was an increase of 0.02 ± 0.001 cm on CT scan and 0.38 ± 0.005 mm on IOPA in bone height over 12 months from baseline. Bone density increased by 118.56 ± 3.251 Hounsfield units (HU). There was no progress in the disease, and further bone loss was not noticed. This is in correlation with clinical parameters which showed highly significant gain in CAL (3.57 ± 0.234 mm) and reduction in PD (2.20 ± 0.229 mm) Bisphosphonate therapy as an adjunct to scaling and root planing may have significant beneficial clinical effects on the periodontium of postmenopausal women with moderate to severe chronic periodontitis.

  3. Clinical diagnostic evaluation for scaphoid fractures: a systematic review and meta-analysis

    NARCIS (Netherlands)

    Mallee, Wouter H.; Henny, Erik P.; van Dijk, C. Niek; Kamminga, Sjoerd P.; van Enst, Wynanda A.; Kloen, Peter

    2014-01-01

    To provide an overview of available clinical evaluation tests for scaphoid fractures and to compare their diagnostic accuracies. PWe performed a systematic review of all studies assessing diagnostic characteristics of clinical evaluation in scaphoid fractures by searching MEDLINE, EMBASE, Cochrane,

  4. A prospective clinical study to evaluate the safety and performance of wireless localization of nonpalpable breast lesions using radiofrequency identification technology.

    Science.gov (United States)

    Dauphine, Christine; Reicher, Joshua J; Reicher, Murray A; Gondusky, Christina; Khalkhali, Iraj; Kim, Michelle

    2015-06-01

    The purpose of this study was to evaluate the safety and performance of localizing nonpalpable breast lesions using radiofrequency identification technology. Twenty consecutive women requiring preoperative localization of a breast lesion were recruited. Subjects underwent placement of both a hook wire and a radiofrequency identification tag immediately before surgery. The radiofrequency identification tag was the primary method used by the operating surgeon to localize each lesion during excision, with the hook wire serving as backup in case of tag migration or failed localization. Successful localization with removal of the intended lesion was the primary outcome measured. Tag migration and postoperative infection were also noted to assess safety. Twenty patients underwent placement of a radiofrequency identification tag, 12 under ultrasound guidance and eight with stereotactic guidance. In all cases, the radiofrequency identification tag was successfully localized by the reader at the level of the skin before incision, and the intended lesion was removed along with the radiofrequency identification tag. There were no localization failures and no postoperative infections. Tag migration did not occur before incision, but in three cases, occurred as the lesion was being retracted with fingers to make the final cut along the deep surface of the specimen. In this initial clinical study, radiofrequency tags were safe and able to successfully localize nonpalpable breast lesions. Radiofrequency identification technology may represent an alternative method to hook wire localization.

  5. Assessment of the antidandruff activity of a new shampoo: a randomized, double-blind, controlled study by clinical and instrumental evaluations.

    Science.gov (United States)

    Sparavigna, Adele; Setaro, Michele; Caserini, Maurizio; Bulgheroni, Anna

    2013-01-01

    The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.

  6. Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study.

    Science.gov (United States)

    Fortnum, Heather; Leighton, Paul; Smith, Murray D; Brown, Lisa; Jones, Matthew; Benton, Claire; Marder, Elizabeth; Marshall, Andrew; Sutton, Kate

    2014-09-01

    There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective. To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research. A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis. UK (professionals); East Midlands region of the UK (parents). Parents of children aged 1-11 years with Down syndrome (n = 156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (n = 128). Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or

  7. Contribution of diagnostic tests for the etiological assessment of uveitis, data from the ULISSE study (Uveitis: Clinical and medicoeconomic evaluation of a standardized strategy of the etiological diagnosis).

    Science.gov (United States)

    Grumet, Pierre; Kodjikian, Laurent; de Parisot, Audrey; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Labetoulle, Marc; Broussolle, Christiane; Jamilloux, Yvan; Decullier, Evelyne; Sève, Pascal

    2018-04-01

    ULISSE is the only study that prospectively assessed the efficiency of a standardized strategy, compared to an open strategy for the etiologic diagnosis of uveitis. Our aim was to evaluate the diagnostic yield of the tests prescribed in the ULISSE study to clarify their relevance. ULISSE is a non-inferiority, prospective, multicenter and cluster randomized study. The standardized strategy is a two-steps strategy: in the first step, common standard tests were performed, and in the second step, tests were guided by the clinical and anatomic type of uveitis. We reported the relevance of the diagnostic tests used in the standardized strategy, as well as the profitability of the tests that were prescribed to more than twenty patients in each group. Based on diagnostic criteria, either an ophthalmologist, or an internist, established the profitability of a test by considering whether the test lead to a diagnosis or not. Among the 676 patients included (standardized 303; open 373), a diagnosis was made for 152 (50.4%) in the standardized group and 203 (54.4%) in the open group. The most common entities were HLA-B27 associated uveitis (22%), spondyloarthritis (11%), sarcoidosis (18%), tuberculosis (10.7%) and herpes virus infections (8.5%). Among the first step's systematic tests, tuberculin skin test was the most contributive investigation (17.1%), followed by chest X-ray (8.4%), C reactive protein and ESR (6.6% and 5.1%), complete blood count (2.2%) and VDRL (2.0%). The second step's most often contributive tests were: HLA B27 (56.3%), chest-CT (30.3%) and angiotensin converting enzyme (ACE) (16.5%). HLA B27 and ACE were significantly more contributive in the standardized group than in the open group. Immunological tests were never contributive. Among the free investigations, or among the investigations guided by clinical or paraclinical findings, the most often contributive tests were: Quantiferon® (24%), electrophoresis of serum protein (7.8%) and sacroiliac imagery

  8. Evaluation of performance of veterinary in-clinic hematology analyzers.

    Science.gov (United States)

    Rishniw, Mark; Pion, Paul D

    2016-12-01

    A previous study provided information regarding the quality of in-clinic veterinary biochemistry testing. However, no similar studies for in-clinic veterinary hematology testing have been conducted. The objective of this study was to assess the quality of hematology testing in veterinary in-clinic laboratories using results obtained from testing 3 levels of canine EDTA blood samples. Clinicians prepared blood samples to achieve measurand concentrations within, below, and above their RIs and evaluated the samples in triplicate using their in-clinic analyzers. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index, and agreement between in-clinic and reference laboratory instruments. Suitability for statistical quality control was determined using adaptations from the computerized program, EZRules3. Evaluation of 10 veterinary in-clinic hematology analyzers showed that these instruments often fail to meet quality requirements. At least 60% of analyzers reasonably determined RBC, WBC, HCT, and HGB, when assessed by most quality goal criteria; platelets were less reliably measured, with 80% deemed suitable for low platelet counts, but only 30% for high platelet counts, and automated differential leukocyte counts were generally considered unsuitable for clinical use with fewer than 40% of analyzers meeting the least stringent quality goal requirements. Fewer than 50% of analyzers were able to meet requirements for statistical quality control for any measurand. These findings reflect the current status of in-clinic hematology analyzer performance and provide a basis for future evaluations of the quality of veterinary laboratory testing. © 2016 American Society for Veterinary Clinical Pathology.

  9. Clinical evaluation of immediate loading of electroeroded screw-retained titanium fixed prostheses supported by tilted implant: a multicenter retrospective study.

    Science.gov (United States)

    Acocella, Alessandro; Ercoli, Carlo; Geminiani, Alessandro; Feng, Changyong; Billi, Mauro; Acocella, Gabriele; Giannini, Domenico; Sacco, Roberto

    2012-05-01

    Immediate occlusal loading of dental implants in the edentulous mandible has proven to be an effective, reliable, and predictable treatment protocol. However, there is limited long-term data available in the literature, when an electroeroded definitive cast-titanium fixed prosthesis is used for this treatment protocol. The aim of this study was to evaluate the clinical effectiveness of dental implants (Astra Tech Dental, Mölndal, Sweden) in the edentulous mandible immediately loaded with an electroeroded cast-titanium screw-retained fixed prosthesis. Forty-five patients received five implants each in the interforaminal area. All the implants were inserted with torque up to 40 Ncm and the distal implants were distally tilted approximately 20 to 30 degrees to minimize the length of posterior cantilevers. Implants were loaded within 48 hours of placement with an acrylic resin-titanium screw-retained prosthesis fabricated by electroerosion. Two of the 225 inserted implants failed after 3 and 16 months of healing, respectively, with a cumulative survival rate of 99.1% and a prosthetic survival rate of 97.8%. Immediate loading of tilted dental implants inserted in the edentulous mandible with a screw-retained titanium definitive prosthesis fabricated with electrical discharge machining provide reliable and predictable results. © 2011 Wiley Periodicals, Inc.

  10. Clinical Evaluation of a New-Formula Shampoo for Scalp Seborrheic Dermatitis Containing Extract of Rosa centifolia Petals and Epigallocatechin Gallate: A Randomized, Double-Blind, Controlled Study.

    Science.gov (United States)

    Kim, Yu Ri; Kim, Jeong-Hwan; Shin, Hong-Ju; Choe, Yong Beom; Ahn, Kyu Joong; Lee, Yang Won

    2014-12-01

    Scalp seborrheic dermatitis is a chronic type of inflammatory dermatosis that is associated with sebum secretion and proliferation of Malassezia species. Ketoconazole or zinc-pyrithione shampoos are common treatments for scalp seborrheic dermatitis. However, shampoos comprising different compounds are required to provide patients with a wider range of treatment options. This study was designed to evaluate a new-formula shampoo that contains natural ingredients-including extract of Rosa centifolia petals and epigallocatechin gallate (EGCG)-that exert antioxidative, anti-inflammatory, and sebum secretion inhibitory effects, and antifungal agents for the treatment of scalp seborrheic dermatitis. Seventy-five patients were randomized into three treatment groups; new-formula shampoo, 2% ketoconazole shampoo, and 1% zinc- pyrithione shampoo. The clinical severity scores and sebum levels were assessed by the same dermatologists at baseline (week 0), and at 2 and 4 weeks after using the shampoo. User satisfaction and irritation were also assessed with the aid of a questionnaire. The efficacy of the new-formula shampoo was comparable to that of both the 1% zinc-pyrithione shampoo and the 2% ketoconazole shampoo. Furthermore, it was found to provide a more rapid response than the 1% zinc-pyrithione shampoo for mild erythema lesions and was associated with greater user satisfaction compared with the 2% ketoconazole shampoo. However, the new-formula shampoo did not exhibit the previously reported sebum inhibitory effect. Extract of R. centifolia petals or EGCG could be useful ingredients in the treatment of scalp seborrheic dermatitis.

  11. Towards clinical implementation of ultrafast combined kV-MV CBCT for IGRT of lung cancer. Evaluation of registration accuracy based on phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Arns, Anna; Blessing, Manuel; Fleckenstein, Jens; Stsepankou, Dzmitry; Boda-Heggemann, Judit; Simeonova-Chergou, Anna; Hesser, Juergen; Lohr, Frank; Wenz, Frederik; Wertz, Hansjoerg [University Medical Center Mannheim, University of Heidelberg, Department of Radiation Oncology, Mannheim (Germany)

    2016-05-15

    Combined kV-MV cone-beam CT (CBCT) is a promising approach to accelerate imaging for patients with lung tumors treated with deep inspiration breath-hold. During a single breath-hold (15 s), a 3D kV-MV CBCT can be acquired, thus minimizing motion artifacts and increasing patient comfort. Prior to clinical implementation, positioning accuracy was evaluated and compared to clinically established imaging techniques. An inhomogeneous thorax phantom with four tumor-mimicking inlays was imaged in 10 predefined positions and registered to a planning CT. Novel kV-MV CBCT imaging (90 arc) was compared to clinically established kV-chest CBCT (360 ) as well as nonclinical kV-CBCT and low-dose MV-CBCT (each 180 ). Manual registration, automatic registration provided by the manufacturer and an additional in-house developed manufacturer-independent framework based on the MATLAB registration toolkit were applied. Systematic setup error was reduced to 0.05 mm by high-precision phantom positioning with optical tracking. Stochastic mean displacement errors were 0.5 ± 0.3 mm in right-left, 0.4 ± 0.4 mm in anteroposterior and 0.0 ± 0.4 mm in craniocaudal directions for kV-MV CBCT with manual registration (maximum errors of no more than 1.4 mm). Clinical kV-chest CBCT resulted in mean errors of 0.2 mm (other modalities: 0.4-0.8 mm). Similar results were achieved with both automatic registration methods. The comparison study of repositioning accuracy between novel kV-MV CBCT and clinically established volume imaging demonstrated that registration accuracy is maintained below 1 mm. Since imaging time is reduced to one breath-hold, kV-MV CBCT is ideal for image guidance, e.g., in lung stereotactic ablative radiotherapy. (orig.) [German] Kombiniertes kV-MV-Cone-Beam-CT (CBCT) ist ein vielversprechender Ansatz zur Beschleunigung der Bildgebung bei Patienten mit Lungentumoren, die mit wiederholter Atemanhaltetechnik in tiefer Inspiration behandelt werden. Waehrend einer einzigen

  12. Effectiveness evaluation of two volumizing hyaluronic acid dermal fillers in a controlled, randomized, double-blind, split-face clinical study

    Directory of Open Access Journals (Sweden)

    Kerscher M

    2017-06-01

    Full Text Available Martina Kerscher,1 Karla Agsten,2 Maria Kravtsov,3 Welf Prager4 1Department of Cosmetic Science, University of Hamburg, 2SCIderm GmbH, Hamburg, Germany; 3Anteis S.A., Geneva, Switzerland; 4Prager & Partner Dermatologische Praxis, Hamburg, Germany Background: Enhancement of the midface can be achieved with volumizing hyaluronic acid (HA fillers.Objective: The objective of this study was to compare the safety and effectiveness of Cohesive Polydensified Matrix® 26 mg/mL HA gel (CPM-26 and Vycross® 20 mg/ml HA gel (VYC-20 in a controlled, randomized, evaluator-blind, split-face clinical study.Patients and methods: Subjects with moderate-to-severe malar volume loss on the Merz Aesthetics Scale (MAS received CPM-26 on one side and VYC-20 on the contralateral side of the face. Effectiveness assessments were performed by blinded evaluators including photographic and live MAS ratings and live Global Aesthetic Improvement Scale (GAIS ratings. Calculations of anatomical volume variations at month 3 (M3, month 6 (M6, month 12 (M12 and month 18 (M18 were also performed.Results: Non-inferiority of CPM-26 versus VYC-20 was demonstrated at M3 (primary end point based on MAS. GAIS rating showed that significantly more subjects had better improvement with CPM-26 than with VYC-20 at month 1, M3, M12 and M18 (p=0.0032, p=0.0074, p=0.0384 and p=0.0110, respectively. Standardized evaluation of volume variations from baseline to M3, M12 and M18 showed that CPM-26 created more volume augmentation at all time points, and the difference was significant at M3.Conclusion: CPM-26 was non-inferior to VYC-20 based on MAS ratings at M3 and demonstrated a favorable safety and effectiveness profile for midfacial volume enhancement with results lasting up to M18. Keywords: cohesive polydensified matrix, hyaluronic acid fillers, Belotero® Volume, Modélis® SHAPE, Juvéderm® VOLUMA®, volumizing

  13. Clinical evaluation of postradiation dental extraction

    International Nuclear Information System (INIS)

    Kusukawa, Jingo; Ohisi, Shinichiro; Kameyama, Tadamitsu; Yoshizumi, Munehiro; Hayabuchi, Naofumi

    1996-01-01

    Twenty-one patients who had undergone postradiation dental extraction were evaluated clinically. All patients had received irradiation for primary head and neck malignancies at doses ranging from 8 to 60 Gy (mean, 51.6 Gy). Time to dental extraction after irradiation ranged from 8 to 156 months (mean, 57.9 months). Of the 21 patients (80 teeth extracted, including 33 maxillary teeth and 47 mandibular teeth), one had delayed healing after wisdom tooth extraction due to postextraction irradiation. Thus, osteoradionecrosis after dental extraction did not develop. These results suggest that dental extraction after radiation is not contraindicated. To prevent complications, patients who have received radiation and require extractions should be cared for by oral and maxillofacial surgeons in close association with radiation oncologists. (author)

  14. [Clinical evaluation of flomoxef in children].

    Science.gov (United States)

    Meguro, H; Arimasu, O; Sugamata, K; Shiraishi, H; Kobayashi, M; Fujii, R; Mashiko, J; Nagao, Y; Okamoto, Y

    1987-08-01

    Flomoxef (FMOX, 6315-S), a new parenteral oxacephem antibiotic, was evaluated for its safety, efficacy and pharmacokinetics in children. Twenty-six patients with bacterial infections were treated with FMOX. Clinical efficacy rate was 92% and bacteriological cure rate was 85%. Three cases of infections due to methicillin-resistant Staphylococcus aureus were cured with FMOX therapy. No severe adverse reactions or abnormalities of laboratory test data were associated with FMOX therapy, although loose stools and diarrhea occurred frequently (23%). Serum half-lives of FMOX after a single bolus injection of 9 infants and children were 0.77 +/- 0.31 hour and excretion into urine was rapid. From these experiences, FMOX appeared to be a safe and effective antibiotic when used in children with susceptible bacterial infections.

  15. How nurses seek and evaluate clinical guidelines on the Internet

    NARCIS (Netherlands)

    Verhoeven, F.; Steehouder, M.F.; Hendrix, Ron M.G.; van Gemert-Pijnen, Julia E.W.C.

    2010-01-01

    Aim: This paper is a report of a study conducted to assess nurses’ information-seeking strategies and problems encountered when seeking clinical guidelines on the Internet, and to investigate the criteria they apply when evaluating the guidelines and the websites communicating the guidelines. -

  16. A comparative study to evaluate the discrepancy in condylar guidance values between two commercially available arcon and non-arcon articulators: A clinical study

    Directory of Open Access Journals (Sweden)

    Mukesh Kumar Goyal

    2011-01-01

    Full Text Available Aim: The purpose of this study was comparative evaluation of sagittal condylar values of arcon and non-arcon articulators with cephalometric readings and to determine the amount of discrepancy in sagittal condylar guidance values between arcon and non-arcon articulators using same protrusive record. Materials and Methods: Twenty subjects in the age group of 19-35 years, free from temporomandibular joint dysfunction, and occlusal disharmony, with healthy dentition participated in the study. Hanau H2 (non-arcon type and Hanau Wide-Vue (arcon type articulators were programmed for sagittal condylar guidance values using the same protrusive record made in polysiloxane bite registration material with edge to edge degree of protrusion. The resultant values for both the articulators on either side were compared with values obtained from tracing of digital lateral cephalogram using Kodak Dental imaging Window software 6.6.3.0-C program. The tabulated data were subjected to statistical analysis, ANOVA (Fishers ′F′ test for group comparison, Tukey′s HSD test for inter-comparison, student′s unpaired ′t′ test for intra-group comparison, and level of significance (P was calculated using the same. Results: The mean sagittal condylar guidance values of the three different groups were found to be very highly significant (P=0.001 and highly significant (P=0.002 on the right and left sides respectively. There was a very highly significant difference (P=0.001 and highly significant difference (P=0.003 between the arcon and non-arcon group on the right and left side respectively. No significant difference was found between the arcon and cephalometric group (P=0.284 right, P=0.853 left and a statistically significant difference was found between the non-arcon and cephalometric group (P=0.049 right, P=0.015 left. On intragroup comparison there was no statistically significant difference in sagittal condylar values on the right and left sides. Conclusion

  17. Clinical evaluation based on cost-effectiveness

    International Nuclear Information System (INIS)

    Inoue, Takehiro; Inoue, Toshihiko

    1998-01-01

    We carried out two Phase III clinical trials using high dose rate (HDR) remote afterloading brachytherapy unit. We evaluated the clinical results based not only on the medical but also the economical standpoint. The first trial is the Phase III trial for cervical cancer treated with HDR or medium dose rate (MDR) intracavitary radiotherapy. The second one is the Phase III trial for tongue cancer treated with HDR or low dose rate (LDR) interstitial radiation. For cervical cancer, the survival rate of patients treated with HDR brachytherapy is the some as for LDR brachytherapy. The average total cost of treatment for the HDR group was 1.47 million yen, while that for the MDR group was 1.58 million yen. The average total admission days was 63. For tongue cancer, the local control rate of the HDR group is almost the same as that of the LDR groups. The average total cost for the HDR group was 780 thousand yen, and that for the LDR group was 830 thousand yen. The average total admission days was 34. According to the cost-effectiveness, HDR brachytherapy for cervical cancer has the same result as MDR, and HDR brachytherapy for tongue cancer has the same result as LDR. However, HDR can be treated without admission for patients who live near the hospital. HDR can be applied for these patients with less expense. We must be aware of not only the medical results but also the cost-effectiveness. (author)

  18. A four-week clinical study to evaluate and compare the effectiveness of a baking soda dentifrice and an antimicrobial dentifrice in reducing plaque.

    Science.gov (United States)

    Ghassemi, Annahita; Vorwerk, Linda M; Hooper, William J; Putt, Mark S; Milleman, Kimberly R

    2008-01-01

    To evaluate and compare the effectiveness in reducing plaque of a fluoride dentifrice containing baking soda and a non-baking soda fluoride dentifrice containing an antimicrobial (triclosan/copolymer) system after a single brushing and over a four-week period of daily brushing. A total of 207 subjects completed this randomized, blinded, parallel-group clinical study. Twenty-four hour plaque buildup was scored at baseline and after two and four weeks of twice-daily use of the products. Additionally, controlled single brushing with the assigned dentifrice, followed by post-brushing plaque assessment, was performed at the start (baseline visit) and end (Week-4 visit) of the study. Plaque was scored using the Turesky, et al. modification of Quigley-Hein Index at six sites per tooth, according to Soparkar's modification. Mean baseline whole mouth plaque scores for the baking soda and triclosan dentifrice groups were 2.90 +/- 0.40 and 2.90 +/- 0.39, respectively, and the difference was not statistically significant. Within-group analysis showed that both products significantly reduced the amount of plaque over the four-week period (p baking soda dentifrice exhibited significantly greater reduction in plaque scores (p baking soda dentifrice group (0.34 +/- 0.32) was 2.22-fold greater than that observed for the triclosan dentifrice group (0.15 +/- 0.24). Similarly, single brushing with the baking soda dentifrice showed a 1.88- to 2.08-fold greater pre- to post-brushing plaque difference as compared to the triclosan dentifrice at the baseline visit (mean plaque reduction: baking soda 0.54 +/- 0.26; triclosan 0.28 +/- 0.18; ratio 1.88X) and Week-4 visit (baking soda 0.47 +/- 0.21; triclosan 0.23 +/- 0.15; ratio 2.08X). Similar to the whole mouth scores, evaluation of various tooth sites (facial, lingual, proximal, and gingival) showed a significantly greater reduction in plaque scores for brushing with the baking soda dentifrice as compared to brushing with the triclosan

  19. Epidemiological, clinical and sleep laboratory evaluations of insomnia

    Science.gov (United States)

    Bixler, E. O.; Kales, A.; Kales, J. D.

    1975-01-01

    Epidemiological studies have contributed to the understanding of the total scope of the insomnia problem, both in terms of the incidence of sleep difficulties, and the extent and frequency of hypnotic drug use. Clinical studies - at the Sleep Research and Treatment Center - have been used to evaluate the medical, psychological, pharmacological and situational factors contributing to insomnia, and to evaluate the psychotherapy and chemotherapy best suited to treatment of insomnia. The sleep laboratory studies were of two types: (1) the study of sleep induction, sleep maintenance, and sleep stages, and (2) the use of hypnotic drugs, emphasizing their effectiveness in inducing and maintaining sleep, and the duration of this effectiveness.

  20. Multicenter clinical study for evaluation of efficacy and safety of transdermal fentanyl matrix patch in treatment of moderate to severe cancer pain in 474 chinese cancer patients.

    Science.gov (United States)

    Zhu, Yu-Lin; Song, Guo-Hong; Liu, Duan-Qi; Zhang, Xi; Liu, Kui-Feng; Zang, Ai-Hua; Cheng, Ying; Cao, Guo-Chun; Liang, Jun; Ma, Xue-Zhen; Ding, Xin; Wang, Bin; Li, Wei-Lian; Hu, Zuo-Wei; Feng, Gang; Huang, Jiang-Jin; Zheng, Xiao; Jiao, Shun-Chang; Wu, Rong; Ren, Jun

    2011-12-01

    Although a new matrix formulation fentanyl has been used throughout the world for cancer pain management, few data about its efficacy and clinical outcomes associated with its use in Chinese patients have been obtained. This study aimed to assess the efficacy and safety of the new system in Chinese patients with moderate to severe cancer pain. A total of 474 patients with moderate to severe cancer pain were enrolled in this study and were treated with the new transdermal fentanyl matrix patch (TDF) up to 2 weeks. All the patients were asked to record pain intensity, side effects, quality of life (QOL), adherence and global satisfaction. The initial dose of fentanyl was 25 μg/h titrated with opioid or according to National Comprehensive Cancer Network (NCCN) guidelines. Transdermal fentanyl was changed every three days. After 2 weeks. The mean pain intensity of the 459 evaluated patients decreased significantly from 5.63±1.26 to 2.03±1.46 (P<0.0001). The total remission rate was 91.29%, of which moderate remission rate 53.16%, obvious remission rate 25.49% and complete remission rate 12.64%. The rate of adverse events was 33.75%, 18.78% of which were moderate and 3.80% were severe. The most frequent adverse events were constipation and nausea. No fatal events were observed. The quality of life was remarkably improved after the treatment (P<0.0001). The new TDF is effective and safe in treating patients with moderate to severe cancer pain, and can significantly improve the quality of life.

  1. Comparative evaluation of a bioabsorbable collagen membrane and connective tissue graft in the treatment of localized gingival recession: A clinical study

    Directory of Open Access Journals (Sweden)

    Harsha Mysore Babu

    2011-01-01

    Full Text Available Background: Gingival recession (GR can result in root sensitivity, esthetic concern to the patient, and predilection to root caries. The purpose of this randomized clinical study was to evaluate (1 the effect of guided tissue regeneration (GTR procedure using a bioabsorbable collagen membrane, in comparison to autogenous subepithelial connective tissue graft (SCTG for root coverage in localized gingival recession defects; and (2 the change in width of keratinized gingiva following these two procedures. Materials and Methods: A total of 10 cases, showing at least two localized Miller′s Class I or Class II gingival recession, participated in this study. In a split mouth design, the pairs of defects were randomly assigned for treatment with either SCTG (SCTG Group or GTR-based collagen membrane (GTRC Group. Both the grafts were covered with coronally advanced flap. Recession depth (RD, recession width (RW, width of keratinized gingiva (KG, probing depth (PD, relative attachment level (RAL, plaque index (PI, and gingival index (GI were recorded at baseline, 3 and 6 months postoperatively. Results: Six months following root coverage procedures, the mean root coverage was found to be 84.84% ± 16.81% and 84.0% ± 15.19% in SCTG Group and GTRC Group, respectively. The mean keratinized gingival width increase was 1.50 ± 0.70 mm and 2.30 ± 0.67 mm in the SCTG and GTRC group, respectively, which was not statistically significant. Conclusion: It may be concluded that resorbable collagen membrane can be a reliable alternative to autogenous connective tissue graft in the treatment of gingival recession.

  2. Clinical Evaluation of Clofazimine in Vitiligo

    Directory of Open Access Journals (Sweden)

    K C Shah

    1981-01-01

    Full Text Available In a purely clinical unbiased study, fifty patients′ with multifocal extensive, vitiligo were given oral clofazimine therapy for six months and another fifty patients were kept as controls. All the patients were exposed to sunrays for thirty minutes daily. Significantly more patients in the treated group developed pigmentation of the patches compared to the, control group. But,the pigment dis appeared soon after stopping the treatment. It may be tried in extensive multifocal vitiligo cases only where known therapeutic agents are not effective.

  3. Exercise intolerance in pulmonary hypertension: mechanism, evaluation and clinical implications.

    Science.gov (United States)

    Babu, Abraham Samuel; Arena, Ross; Myers, Jonathan; Padmakumar, Ramachandran; Maiya, Arun G; Cahalin, Lawrence P; Waxman, Aaron B; Lavie, Carl J

    2016-09-01

    Exercise intolerance in pulmonary hypertension (PH) is a major factor affecting activities of daily living and quality of life. Evaluation strategies (i.e., non-invasive and invasive tests) are integral to providing a comprehensive assessment of clinical and functional status. Despite a growing body of literature on the clinical consequences of PH, there are limited studies discussing the contribution of various physiological systems to exercise intolerance in this patient population. This review, through a search of various databases, describes the physiological basis for exercise intolerance across the various PH etiologies, highlights the various exercise evaluation methods and discusses the rationale for exercise training amongst those diagnosed with PH. Expert commentary: With the growing importance of evaluating exercise capacity in PH (class 1, Level C recommendation), understanding why exercise performance is altered in PH is crucial. Thus, the further study is required for better quality evidence in this area.

  4. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    Science.gov (United States)

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  5. Clinical application of S-Detect to breast masses on ultrasonography: A study evaluating the diagnostic performance and agreement with a dedicated breast radiologist

    International Nuclear Information System (INIS)

    Kim, Ki Wook; Kim, Eun Kyung; Yoon, Jung Hyun; Song, Mi Kyung

    2017-01-01

    The purpose of this study was to evaluate the diagnostic performance of S-Detect when applied to breast ultrasonography (US), and the agreement with an experienced radiologist specializing in breast imaging. From June to August 2015, 192 breast masses in 175 women were included. US features of the breast masses were retrospectively analyzed by a radiologist who specializes in breast imaging and S-Detect, according to the fourth edition of the American College of Radiology Breast Imaging Reporting and Data System lexicon and final assessment categories. Final assessments from S-Detect were in dichotomized form: possibly benign and possibly malignant. Kappa statistics were used to analyze the agreement between the radiologist and S-Detect. Diagnostic performance of the radiologist and S-Detect was calculated, including sensitivity, specificity, positive predictive value (PPV), negative predictive value, accuracy, and area under the receiving operator characteristics curve. Of the 192 breast masses, 72 (37.5%) were malignant, and 120 (62.5%) were benign. Benign masses among category 4a had higher rates of possibly benign assessment on S-Detect for the radiologist, 63.5% to 36.5%, respectively (P=0.797). When the cutoff was set at category 4a, the specificity, PPV, and accuracy was significantly higher in S-Detect compared to the radiologist (all P<0.05), with a higher area under the receiver operator characteristics curve of 0.725 compared to 0.653 (P=0.038). Moderate agreement (k=0.58) was seen in the final assessment between the radiologist and S-Detect. S-Detect may be used as an additional diagnostic tool to improve the specificity of breast US in clinical practice, and guide in decision making for breast masses detected on US

  6. SU-E-T-83: A Study On Evaluating the Directional Dependency of 2D Seven 29 Ion Chamber Array Clinically with Different IMRT Plans

    Energy Technology Data Exchange (ETDEWEB)

    Kumar, Syam [Malabar Cancer Centre, Kannur, Kerala (India); Aswathi, C.P. [University of Calicut, Calicut, Kerala (India)

    2015-06-15

    Purpose: To evaluate the directional dependency of 2D seven 29 ion chamber array clinically with different IMRT plans. Methods: 25 patients already treated with IMRT plans were selected for the study. Verification plans were created for each treatment plan in eclipse 10 treatment planning system using the AAA algorithm with the 2D array and the Octavius CT phantom. Verification plans were done 2 times for a single patient. First plan with real IMRT (plan-related approach) and second plan with zero degree gantry angle (field-related approach). Measurements were performed on a Varian Clinac-iX, linear accelerator equipped with a millennium 120 multileaf collimator. Fluence was measured for all the delivered plans and analyzed using the verisoft software. Comparison was done by selecting the fluence delivered in static gantry (zero degree gantry) versus IMRT with real gantry angles. Results: The gamma pass percentage is greater than 97 % for all IMRT delivered with zero gantry angle and between 95%–98% for real gantry angles. Dose difference between the TPS calculated and measured for IMRT delivered with zero gantry angle was found to be between (0.03 to 0.06Gy) and with real gantry angles between (0.02 to 0.05Gy). There is a significant difference between the gamma analysis between the zero degree and true angle with a significance of 0.002. Standard deviation of gamma pass percentage between the IMRT plans with zero gantry angle was 0.68 and for IMRT with true gantry angle was found to be 0.74. Conclusion: The gamma analysis for IMRT with zero degree gantry angles shows higher pass percentage than IMRT delivered with true gantry angles. Verification plans delivered with true gantry angles lower the verification accuracy when 2D array is used for measurement.

  7. A randomised controlled trial on evaluation of the clinical efficacy of massage therapy in a multisensory environment for residents with severe and profound intellectual disabilities: a pilot study.

    Science.gov (United States)

    Chan, J S L; Chien, W T

    2017-06-01

    Recent literature has suggested that relaxation activities can reduce the challenging behaviours of people with intellectual disabilities, particularly in severe and profound grades, due to the counteractive effect of muscle relaxation on emotional frustration or psychological distress. Despite having inconclusive evidence, multisensory environment (MSE) and massage therapy (MT) are the commonly used approaches to relaxation among these people. However, these two approaches have not yet practised or tested in combination for reducing these people's challenging behaviours. A preliminary clinical efficacy trial was conducted to evaluate the effects of MT, MSE and their combined use for residents with intellectual disabilities in a long-term care facility on reducing their challenging behaviours. Eligible residents were recruited and randomly assigned to one of the four study groups (n = 11-12 per group), that is, MT in MSE, MSE alone, MT alone or usual care, for a 10-week intervention after a 1-month washout period. Outcome measures, including the Behaviour Problem Inventory, pulse and respiration rates, Behaviour Checklist and Alertness Observation Checklist, were assessed at recruitment and immediately following the interventions. A total of 42 participants (17 men and 25 women) completed the study. There were no significant differences in frequency and severity of challenging behaviours and most of the outcome measures between the four groups at post-test. Nevertheless, there were statistical significant differences on the active and inactive state (Alertness Observation Checklist) between the three treatment and control groups. Many participants in the three treatment groups changed from an active to inactive state (i.e. reduced activity levels) throughout the interventions, especially the MT in MSE. Such inactivity might suggest the participants' brief exhaustion followed by a period of alertness during the treatment activities. But their attention span and

  8. Syncope: causes, clinical evaluation, and current therapy.

    Science.gov (United States)

    Benditt, D G; Remole, S; Milstein, S; Bailin, S

    1992-01-01

    Syncope is a common clinical problem comprising the sudden loss of both consciousness and postural tone, with a subsequent spontaneous and relatively prompt recovery. Often it is difficult to differentiate a true syncopal spell from other conditions, such as seizure disorders, or from some simple accidents. Even more difficult is the identification of the cause of syncopal episodes. Nonetheless, establishing a definitive diagnosis ia an important task given the high risk of recurrent symptoms. Careful use of noninvasive and invasive cardiovascular studies (including electrophysiologic testing and tilt-table testing) along with selected hematologic, biochemical, and neurologic studies provides, in the majority of cases, the most effective strategy for obtaining a specific diagnosis and for directing therapy.

  9. [Subsidence and its effects on the anterior plate stabilization in the course of cervical interbody spondylodesis. Part II. Clinical evaluation. Study design].

    Science.gov (United States)

    Hakało, Jerzy; Wroński, Jerzy

    2003-01-01

    Subsidence is a common phenomenon in the process of interbody fusion. The paper presents a retrospective clinical and radiological evaluation of subsidence in a group of 23 patients after cervical corpectomy with mesh cage and plate stabilization. Subsidence magnitude and its impact on the stabilizing system and on the clinical and radiological outcome were estimated. The mesh cage and cervical plate stabilization was preformed after one- (20 cases) or two-level (3 cases) corpectomy. The patients' mean age was 35 years (age range 18-72); 9 patients were aged over 50. Indications to corpectomy were: neurological impairment due to burst body fractures in 14 cases, multilevel spondylosis in 5, and OPLL in 2 patients. One patient had a kidney cancer metastasis. The mean follow-up period was 17 months (range 12-28 mo.). The patients' clinical status was evaluated using the ASIA scale in the post-traumatic group, and the Odom criteria in spondylotic cases. In all the cases pain severity was estimated by the VAS scale. Magnitude of subsidence was measured on consecutive lateral x-rays during the follow-up. Bone fusion was confirmed after 3 months in lateral flexion-extension x-rays. Changes in the local and general cervical lordosis were evaluated during the follow-up. A 72-year-old patient died after 6 weeks due to causes unrelated to the surgery. In all the remaining patients bone fusion was attained. There were no cases of the clinical status deterioration during the follow-up. Subsidence of over 1 mm was found in 19 patients (86.4%). The mean value of subsidence was 2.2 mm, but in a group of older patients (aged over 50) it amounted to 2.8 mm. In 4 cases (18.1%) with hardware complications, i.e. a screw breakage or slipping, the mean subsidence magnitude was 4.3 mm. Local and general cervical lordosis were maintained during the follow-up period, even in the group with excessive subsidence. The screw breakage site was invariably the round hole of the plate. The

  10. Evaluation of clinical information modeling tools.

    Science.gov (United States)

    Moreno-Conde, Alberto; Austin, Tony; Moreno-Conde, Jesús; Parra-Calderón, Carlos L; Kalra, Dipak

    2016-11-01

    Clinical information models are formal specifications for representing the structure and semantics of the clinical content within electronic health record systems. This research aims to define, test, and validate evaluation metrics for software tools designed to support the processes associated with the definition, management, and implementation of these models. The proposed framework builds on previous research that focused on obtaining agreement on the essential requirements in this area. A set of 50 conformance criteria were defined based on the 20 functional requirements agreed by that consensus and applied to evaluate the currently available tools. Of the 11 initiative developing tools for clinical information modeling identified, 9 were evaluated according to their performance on the evaluation metrics. Results show that functionalities related to management of data types, specifications, metadata, and terminology or ontology bindings have a good level of adoption. Improvements can be made in other areas focused on information modeling and associated processes. Other criteria related to displaying semantic relationships between concepts and communication with terminology servers had low levels of adoption. The proposed evaluation metrics were successfully tested and validated against a representative sample of existing tools. The results identify the need to improve tool support for information modeling and software development processes, especially in those areas related to governance, clinician involvement, and optimizing the technical validation of testing processes. This research confirmed the potential of these evaluation metrics to support decision makers in identifying the most appropriate tool for their organization. Los Modelos de Información Clínica son especificaciones para representar la estructura y características semánticas del contenido clínico en los sistemas de Historia Clínica Electrónica. Esta investigación define, prueba y valida

  11. Clinical scoring and instrumental analysis to evaluate skin types.

    Science.gov (United States)

    Mercurio, D G; Segura, J H; Demets, M B A; Maia Campos, P M B G

    2013-04-01

    The biology of the skin is very complex, and there are a number of methods used to classify the different skin types. It is possible to measure or quantify the characteristics of the specific skin types, using a variety of techniques that can objectively evaluate the properties of the skin in a noninvasive manner. To clinically characterize different skin types by dermatological evaluation and biophysical and skin imaging techniques, and to evaluate the relationship between the different characteristics. The study recruited 26 volunteers. Clinical scoring was performed by a dermatologist who classified the volunteers' skin as normal or dry (group 1) and combination or oily (group 2). Objective measurements included skin microrelief, pH, oiliness, water content of the stratum corneum and transepidermal water loss (TEWL). Positive correlations were found between the level of skin oiliness and skin texture obtained from both instrumental analysis and clinical scoring. The combination and oily skin types had higher clinical scores for shine intensity, oiliness and tendency to pigmentation, and also had higher objective scores for sebum secretion, TEWL and roughness. Biophysical and skin imaging techniques are effective tools to help characterize skin type and assist in clinical dermatology. We found that different skin types had different characteristics related to skin microrelief, oiliness and TEWL, and therefore require specific dermatological treatments. © The Author(s) CED © 2013 British Association of Dermatologists.

  12. Evaluation of clinical and metabolic changes after non surgical periodontal treatment of type 2 diabetes mellitus patients: A clinico biochemical study

    Directory of Open Access Journals (Sweden)

    Kudva Praveen

    2010-01-01

    Full Text Available Aim: To evaluate the clinical and metabolic changes following nonsurgical periodontal therapy of type-2 diabetic patients and nondiabetic patients. Materials and Methods: Fifteen nondiabetics and fifteen type-2 diabetics with moderate to severe periodontitis were selected after meeting inclusion and exclusion criteria. Periodontal pocket probing was performed using a Williams graduated periodontal probe and comparisons of the clinical and biochemical parameters like plaque index, gingival index, probing depth, glycated hemoglobin, and lipid profile (total cholesterol, high density lipoprotein, low density lipoprotein, triglycerides and very low density lipoprotein were done between and within two groups at baseline and 3 month. Results: A correlation was observed between clinical and biochemical parameters between and within two groups at baseline and 3 month. The P value of diabetic group was<0.001 in all clinical parameters (plaque index PI, Gingival index GI, and Probing Pocket Depth PPD in diabetic and nondiabetic group, showed statistically highly significant difference in GI, PI, PPD, <.01 in Glycated Hemoglobulin (HbAlc1 in test group and<0.05 in control group showed statistically significant difference. The P value of test group was >0.05 in Lipid profile (total cholesterol, low density lipoprotein, high density lipoprotein, serum triglyceride, very low density lipoprotein that showed no significant difference and in control group<0.05 in total Cholesterol, high density lipoprotein and <0.01 in Low density lipoprotein, Very Low Density Lipoprotein, and Serum Triglyceride, respectively, showed statistically significant in Total cholesterol, Low density lipoprotein, Very Low Density Lipoprotein, and Serum Triglyceride, not significant in high density lipoprotein. The P value >0.05 showed no statistical significance of correlation between the test and control groups. Conclusion: Both groups of patients showed an improvement in clinical and

  13. Clinical image quality evaluation for panoramic radiography in Korean dental clinics

    Energy Technology Data Exchange (ETDEWEB)

    Choi, Bo Ram; Choi, Da Hye; Huh, Kyung Hoe; Yi, Won Jin; Heo, Min Suk; Choi, Soon Chul; Bae, Kwang Hak; Lee, Sam Sun [School of Dentistry, Seoul National University, Seoul (Korea, Republic of)

    2012-09-15

    The purpose of this study was to investigate the level of clinical image quality of panoramic radiographs and to analyze the parameters that influence the overall image quality. Korean dental clinics were asked to provide three randomly selected panoramic radiographs. An oral and maxillofacial radiology specialist evaluated those images using our self-developed Clinical Image Quality Evaluation Chart. Three evaluators classified the overall image quality of the panoramic radiographs and evaluated the causes of imaging errors. A total of 297 panoramic radiographs were collected from 99 dental hospitals and clinics. The mean of the scores according to the Clinical Image Quality Evaluation Chart was 79.9. In the classification of the overall image quality, 17 images were deemed 'optimal for obtaining diagnostic information,' 153 were 'adequate for diagnosis,' 109 were 'poor but diagnosable,' and nine were 'unrecognizable and too poor for diagnosis'. The results of the analysis of the causes of the errors in all the images are as follows: 139 errors in the positioning, 135 in the processing, 50 from the radiographic unit, and 13 due to anatomic abnormality. Panoramic radiographs taken at local dental clinics generally have a normal or higher-level image quality. Principal factors affecting image quality were positioning of the patient and image density, sharpness, and contrast. Therefore, when images are taken, the patient position should be adjusted with great care. Also, standardizing objective criteria of image density, sharpness, and contrast is required to evaluate image quality effectively.

  14. Comparative evaluation of efficacy of three treatment modalities – tetracycline fibers, scaling and root planing, and combination therapy: A clinical study

    Directory of Open Access Journals (Sweden)

    Aashima Bajaj Dang

    2016-01-01

    Full Text Available Background: Tetracycline is one of the primary antibiotics prescribed for antimicrobial therapy in periodontics. It has a broad spectrum of activity being effective against most bacteria as well as spirochetes. Due to limitations of systemic drug therapy, recent formulations of the drug for local administration in the subgingival area have been introduced, including collagen fibers impregnated with tetracycline. Aims and Objective: To compare the effectiveness of tetracycline fibers alone or in combination with scaling and root planing (SRP on clinical parameters in chronic periodontitis patients. Materials and Methods: A total of twenty patients comprising of both sexes in the age group of 35-60 years with chronic periodontitis were selected. Split-mouth design was used, and three teeth from each patient with periodontal pocket measuring > 5 mm were selected which were treated with different treatment modality. They were randomly divided into site A (SRP, site B (tetracycline fibers only, and site C (combination therapy. Clinical parameters of plaque index (PI, gingival index (GI, pocket probing depth, and clinical attachment level (CAL were recorded at 0, 30, and 45 days. The data obtained was compiled and put to statistical analysis. Results: All the three groups showed improvement in PI, GI, probing pocket depth, and CAL. Results of the study showed greater improvements in clinical parameters in Group C compared to Group A and Group B. Conclusion: The results indicate that the adjunctive use of tetracycline fibers with SRP is a clinically effective and simple nonsurgical treatment method to improve periodontal health.

  15. Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results

    Science.gov (United States)

    Smeltzer, Matthew P.; Rugless, Fedoria E.; Jackson, Bianca M.; Berryman, Courtney L.; Faris, Nicholas R.; Ray, Meredith A.; Meadows, Meghan; Patel, Anita A.; Roark, Kristina S.; Kedia, Satish K.; DeBon, Margaret M.; Crossley, Fayre J.; Oliver, Georgia; McHugh, Laura M.; Hastings, Willeen; Osborne, Orion; Osborne, Jackie; Ill, Toni; Ill, Mark; Jones, Wynett; Lee, Hyo K.; Signore, Raymond S.; Fox, Roy C.; Li, Jingshan; Robbins, Edward T.; Ward, Kenneth D.; Klesges, Lisa M.

    2018-01-01

    Background Responsible for 25% of all US cancer deaths, lung cancer presents complex care-delivery challenges. Adoption of the highly recommended multidisciplinary care model suffers from a dearth of good quality evidence. Leading up to a prospective comparative-effectiveness study of multidisciplinary vs. serial care, we studied the implementation of a rigorously benchmarked multidisciplinary lung cancer clinic. Methods We used a mixed-methods approach to conduct a patient-centered, combined implementation and effectiveness study of a multidisciplinary model of lung cancer care. We established a co-located multidisciplinary clinic to study the implementation of this care-delivery model. We identified and engaged key stakeholders from the onset, used their input to develop the program structure, processes, performance benchmarks, and study endpoints (outcome-related process measures, patient- and caregiver-reported outcomes, survival). In this report, we describe the study design, process of implementation, comparative populations, and how they contrast with patients within the local and regional healthcare system. Trial Registration: ClinicalTrials.gov Identifier: NCT02123797. Results Implementation: the multidisciplinary clinic obtained an overall treatment concordance rate of 90% (target >85%). Satisfaction scores were high, with >95% of patients and caregivers rating themselves as being “very satisfied” with all aspects of care from the multidisciplinary team (patient/caregiver response rate >90%). The Reach of the multidisciplinary clinic included a higher proportion of minority patients, more women, and younger patients than the regional population. Comparative effectiveness: The comparative effectiveness trial conducted in the last phase of the study met the planned enrollment per statistical design, with 178 patients in the multidisciplinary arm and 348 in the serial care arm. The multidisciplinary cohort had older age and a higher percentage of racial

  16. Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human—Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans-

    Science.gov (United States)

    Goda, Keisuke; Kobayashi, Akio; Takahashi, Akemi; Takahashi, Tadakazu; Saito, Kosuke; Maekawa, Keiko; Saito, Yoshiro; Sugai, Shoichiro

    2017-01-01

    In the development of drugs, we sometimes encounter fatty change of the hepatocytes (steatosis) which is not accompanied by degenerative change in the liver in non-clinical toxicity studies. In this study, we investigated the relationships between fatty change of the hepatocytes noted in non-clinical toxicity studies of compound X, a candidate compound in drug development, and mitochondrial dysfunction in order to estimate the potential risk of the compound to induce drug-induced liver injury (DILI) in humans. We conducted in vivo and in vitro exploratory studies for this purpose. In vivo lipidomics analysis was conducted to investigate the relationships between alteration of the hepatic lipids and mitochondrial dysfunction. In the liver of rats treated with compound X, triglycerides containing long-chain fatty acids, which are the main energy source of the mitochondria, accumulated. Accumulation of these triglycerides was considered to be related to the inhibition of mitochondrial respiration based on the results of in vitro mitochondria toxicity studies. In conclusion, fatty change of the hepatocytes (steatosis) in non-clinical toxicity studies of drug candidates can be regarded as a critical finding for the estimation of their potential risk to induce DILI in humans when the fatty change is induced by mitochondrial dysfunction. PMID:28417920

  17. [Clinical evaluation of flomoxef in neonatal infections].

    Science.gov (United States)

    Okura, K; Yamakawa, M; Kuroki, S; Haruta, T; Kobayashi, Y

    1991-11-01

    Serum concentrations, urinary excretion and clinical responses of flomoxef (FMOX) were studied. The results are summarized as follows. 1. Serum concentrations of FMOX were 17.4 micrograms/ml 1-hour after intravenous injection on the average in 5 cases who received approximately 10 mg/kg, 41.8 micrograms/ml in 2 cases given 20 mg/kg, and 69.6 micrograms/ml in 2 cases given 40 mg/kg, indicating that serum concentrations of FMOX changed in a dose-dependent manner in this range. Average serum half-life (T 1/2) in 4 mature babies was 2.48 hours and that in 6 premature babies was 3.17 hours, indicating that elimination rates in premature cases tend to be slower than those in mature cases. Urinary recovery rates averaged 39.2% in the first 6 hours in 5 cases examined. 2. Five newborns or premature babies received FMOX 33.1-80.2 mg/kg (b.i.d. or t.i.d.) via intravenous route for 5 to 8 days. FMOX showed excellent or good clinical effectiveness in the treatment of all patients including 1 case each of sepsis with urinary infection, furunclal otitis, impetigo, uterogenic fetus infection and urinary infection. Bacteriological responses were also studied, and eradication of identified organisms (Escherichia coli 3 strains and Staphylococcus aureus 2 strains) was obtained upon the FMOX treatment, but in 1 strain of S. aureus showed only a decrease. No adverse reactions were observed in any cases, but a slight elevation of eosinophil was noted in 1 patient receiving a dose of 210 mg a day. From the results obtained in these tests, FMOX appears to be very usefull and safe for the treatment of some infectious diseases in neonates.

  18. Evaluating Faculty Clinical Excellence in the Academic Health Sciences Center.

    Science.gov (United States)

    Carey, Robert M.; And Others

    1993-01-01

    Evaluation of the clinical competence of medical faculty in teaching hospitals is discussed. Different approaches to clinical assessment and theoretical and practical problems in assessing clinical faculty's performance are discussed. A University of Virginia medical school system for evaluation that combines objective and subjective assessment is…

  19. Evaluation of epidemiological studies

    International Nuclear Information System (INIS)

    Breckow, J.

    1995-01-01

    The publication is intended for readers with a professional background in radiation protection who are not experts in the field of epidemiology. The potentials and the limits of epidemiology are shown and concepts and terminology of radioepidemilogic studies as well as epidemiology in general are explained, in order to provide the necessary basis for understanding or performing evaluations of epidemiologic studies. (orig./VHE) [de

  20. Evaluation of aesthetics of implant-supported single-tooth replacements using different bone augmentation procedures : A prospective randomized clinical study

    NARCIS (Netherlands)

    Meijndert, Leo; Meijer, Henny J. A.; Stellingsma, Kees; Stegenga, Boudewijn; Raghoebar, Gerry M.

    2007-01-01

    Objectives: The aim of this study was to evaluate the aesthetics of implant-supported single-tooth replacements using different augmentation procedures in a prospective study with the use of an objective rating index and with a subjective patient questionnaire, and to compare the results with each

  1. Diagnostic accuracy of ultrasonic histogram features to evaluate radiation toxicity of the parotid glands: a clinical study of xerostomia following head-and-neck cancer radiotherapy.

    Science.gov (United States)

    Yang, Xiaofeng; Tridandapani, Srini; Beitler, Jonathan J; Yu, David S; Chen, Zhengjia; Kim, Sungjin; Bruner, Deborah W; Curran, Walter J; Liu, Tian

    2014-10-01

    To investigate the diagnostic accuracy of ultrasound histogram features in the quantitative assessment of radiation-induced parotid gland injury and to identify potential imaging biomarkers for radiation-induced xerostomia (dry mouth)-the most common and debilitating side effect after head-and-neck radiotherapy (RT). Thirty-four patients, who have developed xerostomia after RT for head-and-neck cancer, were enrolled. Radiation-induced xerostomia was defined by the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer morbidity scale. Ultrasound scans were performed on each patient's parotids bilaterally. The 34 patients were stratified into the acute-toxicity groups (16 patients, ≤ 3 months after treatment) and the late-toxicity group (18 patients, > 3 months after treatment). A separate control group of 13 healthy volunteers underwent similar ultrasound scans of their parotid glands. Six sonographic features were derived from the echo-intensity histograms to assess acute and late toxicity of the parotid glands. The quantitative assessments were compared to a radiologist's clinical evaluations. The diagnostic accuracy of these ultrasonic histogram features was evaluated with the receiver operating characteristic (ROC) curve. With an area under the ROC curve greater than 0.90, several histogram features demonstrated excellent diagnostic accuracy for evaluation of acute and late toxicity of parotid glands. Significant differences (P xerostomia monitoring and assessment. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

  2. Clinical evaluation of an automated turning bed.

    Science.gov (United States)

    Melland, H I; Langemo, D; Hanson, D; Olson, B; Hunter, S

    1999-01-01

    The purposes of this study were to assess client comfort and sleep quality, client physiologic response (skin and respiratory status), the effect on the need for caregiver assistance, and cost when using an automated turning bed. Nonexperimental, evaluative study. Twenty-four adult home or long-term care resident subjects who had a degenerative disease, spinal cord injury, stroke, cerebral palsy, or back surgery. Each subject agreed to use the automated turning bed for four weeks. Researchers completed a demographic survey and skin assessment, and assessed each subject for pressure ulcer risk and for the need of assistance of a care giver for turning before and after the four weeks of using the turning bed. Subjects rated the turning bed in terms of comfort and sleep quality. Subjects rated the turning bed as more comfortable than their own bed and expressed satisfaction at the pain relief attained when on the turning bed. While using the turning bed, there was a significant improvement in sleep quality. No skin breakdown or deterioration in respiratory status occurred. Fewer subjects required the assistance of a caregiver for turning when on the turning bed. This automated turning bed shows great promise in meeting a need for patients with limited mobility whether they are homebound or in a residential community. Future studies that further investigate use of the turning bed for postoperative back patients while still in the acute care setting are indicated. Replicative studies with a larger sample size are also indicated.

  3. Clinical evaluation of prefabricated ceramic inlays

    Directory of Open Access Journals (Sweden)

    H Murali

    2016-01-01

    Full Text Available Background: One of the methods to overcome the problem of polymerization contraction of posterior composites is to use prefabricated ceramic inlays in combination with composites. Several studies have shown that these pre fabricated ceramic inlays act as mega fillers which allow a reduction in resin based composite volume by 50-75% and a concomitant reduction in polymerization shrinkage and marginal micro leakage. Moreover the integration of pre fabricated ceramic inlays into composites reduces the overall coefficient of thermal expansion. Aims and Objectives: The performance of cerena prefabricated inlay system was evaluated. Material and Methods: 20 proximo occlusal cavities were restored with cerana prefabricated inlay system in patients. The performance of cerena pre fabricated inlay system in the oral cavity was recorded at base line follow up using Modified USPHS Ryge criteria at the end of 3, 6, and 12 months. Results: The alpha and Bravo values for the anatomic form, marginal integrity and caries assessment was evaluated. Alpha values were ideal. The Cerena pre- fabricated inlay system showed good fracture resistance, good marginal integrity and maintenance of antomic forms at end of 12 months period. Conclusion: The cerena pre-fabricated inlay system is a good treatment modality and provides a good restorative material at the end of 12 months too.

  4. Postoperative MRI evaluation of anorectal malformations with clinical correlation

    International Nuclear Information System (INIS)

    Fukuya, T.; Honda, H.; Kubota, M.; Hayashi, T.; Kawashima, A.; Tateshi, Y.; Shono, T.; Suita, S.; Masuda, K.

    1993-01-01

    Sixteen postoperative patients with anorectal malformation were evaluated by MRI, and the results compared with the clinical assessment. Patients were classified into three groups - good (group 1, n = 10), fair (group 2, n = 3) and poor (group 3, n = 3) - on the basis of Kelly's clinical score of incontinence. The degree of development of the puborectalis and external sphincter muscles and the levator hammock was evaluated on MRI in comparison with patients without anorectal disease. The proportions of fair or poor development of the muscles were 37% in group 1,22% in group 2 and 67% in group 3. Although fair or poor development of the muscles was seen more frequently in group 3, there was no statistically significant difference between groups. However, poorly developed muscles were seen only in patients with fair or poor clinical scores. The difference in the anorectal angle measured on sagittal MRI images between patients in group 1 and groups 2 or 3 was significant. Our study indicates that MRI evaluation based solely on muscle development can be misleading, and measurement of the anorectal angle should be included in the MRI evaluation. (orig.)

  5. A clinical study on the usefulness of CT and MRI imaging in evaluating differential diagnosis and the degree of dementia in vascular dementia

    Energy Technology Data Exchange (ETDEWEB)

    Hagiwara, Mariko [Nippon Medical School, Tokyo (Japan)

    1990-06-01

    In a retrospective review of 117 computed tomography (CT) scans and 56 magnetic resonance imaging (MRI) scans sequentially performed for dementia patients, CT and MRI were compared for assessment of the usefulness in the differential diagnosis and determination of the functional prognosis of vascular dementia. The correlation between CT findings and the degree of mental function was also examined. Since MRI had a higher sensitivity than CT in detecting small infarcts or lacunaes in the perforating area or white matter, it should differentiate vascular dementia from dementia of Alzheimer type. When both dementia of Alzheimer type was clinically diagnosed and infarct areas were detected on either CT or MRI, activity of daily living tended to be poor. Even when mixed type of dementia or vascular dementia was clinically diagnosed in spite of negative findings on either CT or MRI, troublesome behavior was frequently observed, posing the likelihood of dementia of Alzheimer type. The ability of CT and MRI to detect lesions was not correlated with the degree of dementia or aging, even if MRI was capable of detecting smaller lesions. CT was thus considered to be more specific modality for evaluating mental function. The size of lesions on CT was found to be more significant than the number and localization of lesions in determining the degree of dementia in the chronic stage of cerebrovascular disease. The ability of MRI to detect smaller lesions, as well as clinically determined ischemic scores, may assist in the diagnostic differentiation. Lesion size on CT may be an important factor for determining the degree of dementia and functional prognosis. (N.K.).

  6. A clinical study on the usefulness of CT and MRI imaging in evaluating differential diagnosis and the degree of dementia in vascular dementia

    International Nuclear Information System (INIS)

    Hagiwara, Mariko

    1990-01-01

    In a retrospective review of 117 computed tomography (CT) scans and 56 magnetic resonance imaging (MRI) scans sequentially performed for dementia patients, CT and MRI were compared for assessment of the usefulness in the differential diagnosis and determination of the functional prognosis of vascular dementia. The correlation between CT findings and the degree of mental function was also examined. Since MRI had a higher sensitivity than CT in detecting small infarcts or lacunaes in the perforating area or white matter, it should differentiate vascular dementia from dementia of Alzheimer type. When both dementia of Alzheimer type was clinically diagnosed and infarct areas were detected on either CT or MRI, activity of daily living tended to be poor. Even when mixed type of dementia or vascular dementia was clinically diagnosed in spite of negative findings on either CT or MRI, troublesome behavior was frequently observed, posing the likelihood of dementia of Alzheimer type. The ability of CT and MRI to detect lesions was not correlated with the degree of dementia or aging, even if MRI was capable of detecting smaller lesions. CT was thus considered to be more specific modality for evaluating mental function. The size of lesions on CT was found to be more significant than the number and localization of lesions in determining the degree of dementia in the chronic stage of cerebrovascular disease. The ability of MRI to detect smaller lesions, as well as clinically determined ischemic scores, may assist in the diagnostic differentiation. Lesion size on CT may be an important factor for determining the degree of dementia and functional prognosis. (N.K.)

  7. The Value of Screening Parents for Their Risk of Developing Psychological Symptoms After PICU: A Feasibility Study Evaluating a Pediatric Intensive Care Follow-Up Clinic.

    Science.gov (United States)

    Samuel, Victoria M; Colville, Gillian A; Goodwin, Sarah; Ryninks, Kirsty; Dean, Suzanne

    2015-11-01

    This study aimed to assess whether prospectively screening parents for psychological vulnerability would enable beneficial targeting of a subsequent follow-up clinic. Parents of children consecutively admitted to a PICU were assessed for risk of developing posttraumatic stress disorder at discharge using the Posttraumatic Adjustment Scale. High-risk parents were then randomized to the intervention (follow-up clinic, 2 mo after discharge) or control condition. All parents completed Impact of Event Scale-Revised and Hospital Anxiety and Depression Scale at 6 months. Of the 209 parents of 145 children recruited to the study, 78 (37%) were identified, on the basis of their Posttraumatic Adjustment Scale score at baseline, as being at risk of developing posttraumatic stress disorder, and randomized to the control or intervention condition. Follow-up data were provided by 157 of 209 parents (75%). Logistic regression analyses controlling for parent gender and child length of stay showed that high-risk control parents (n = 32) were significantly more likely to score above the clinical cutoff for all three psychological outcomes than parents deemed low risk at baseline (n = 89) (posttraumatic stress: odds ratio = 3.39; 95% CI, 1.28-8.92; p = 0.014; anxiety: odds ratio = 6.34; 95% CI, 2.55-15.76; p parents attended the follow-up clinic appointment they were offered. At follow-up, there were no statistically significant differences between the intervention and control groups, but there were small effect sizes in favor of the intervention for anxiety scores (Cohen d = 0.209) and depression scores (Cohen d = 0.254) CONCLUSIONS:: Screening parents for psychological vulnerability using measures such as the Posttraumatic Adjustment Scale may enable more efficient targeting of support. However, further research is needed on how best to provide effective follow-up intervention for families.

  8. Evaluation of plitidepsin in patients with primary myelofibrosis and post polycythemia vera/essential thrombocythemia myelofibrosis: results of preclinical studies and a phase II clinical trial

    International Nuclear Information System (INIS)

    Pardanani, A; Tefferi, A; Guglielmelli, P; Bogani, C; Bartalucci, N; Rodríguez, J; Extremera, S; Pérez, I; Alfaro, V; Vannucchi, A M

    2015-01-01

    Previous data established that plitidepsin, a cyclic depsipeptide, exerted activity in a mouse model of myelofibrosis (MF). New preclinical experiments reported herein found that low nanomolar plitidepsin concentrations potently inhibited the proliferation of JAK2V617F-mutated cell lines and reduced colony formation by CD34+ cells of individuals with MF, at least in part through modulation of p27 levels. Cells of MF patients had significantly reduced p27 content, that were modestly increased upon plitidepsin exposure. On these premise, an exploratory phase II trial evaluated plitidepsin 5 mg/m 2 3-h intravenous infusion administered on days 1 and 15 every 4 weeks (q4wk). Response rate (RR) according to the International Working Group for Myelofibrosis Research and Treatment consensus criteria was 9.1% (95% CI, 0.2–41.3%) in 11 evaluable patients during the first trial stage. The single responder achieved a red cell transfusion independence and stable disease was reported in nine additional patients (81.8%). Eight patients underwent a short-lasting improvement of splenomegaly. In conclusion, plitidepsin 5 mg/m 2 3-h infusion q4wk was well tolerated but had a modest activity in patients with primary, post-polycythaemia vera or post-essential thrombocythaemia MF. Therefore, this trial was prematurely terminated and we concluded that further clinical trials with plitidepsin as single agent in MF are not warranted

  9. Clinical evaluation of guidelines and two-test approach for lyme disease

    NARCIS (Netherlands)

    Blaauw, A. A.; van Loon, A. M.; Schellekens, J. F.; Bijlsma, J. W.

    1999-01-01

    The diagnosis of Lyme disease should be based on objective clinical signs and symptoms. In a clinical study, we have evaluated whether the recommended two-step approach for serodiagnosis of Lyme disease is useful in daily clinical practice and can influence clinical decision making. The signs and

  10. Semantic Modeling for Exposomics with Exploratory Evaluation in Clinical Context

    Directory of Open Access Journals (Sweden)

    Jung-wei Fan

    2017-01-01

    Full Text Available Exposome is a critical dimension in the precision medicine paradigm. Effective representation of exposomics knowledge is instrumental to melding nongenetic factors into data analytics for clinical research. There is still limited work in (1 modeling exposome entities and relations with proper integration to mainstream ontologies and (2 systematically studying their presence in clinical context. Through selected ontological relations, we developed a template-driven approach to identifying exposome concepts from the Unified Medical Language System (UMLS. The derived concepts were evaluated in terms of literature coverage and the ability to assist in annotating clinical text. The generated semantic model represents rich domain knowledge about exposure events (454 pairs of relations between exposure and outcome. Additionally, a list of 5667 disorder concepts with microbial etiology was created for inferred pathogen exposures. The model consistently covered about 90% of PubMed literature on exposure-induced iatrogenic diseases over 10 years (2001–2010. The model contributed to the efficiency of exposome annotation in clinical text by filtering out 78% of irrelevant machine annotations. Analysis into 50 annotated discharge summaries helped advance our understanding of the exposome information in clinical text. This pilot study demonstrated feasibility of semiautomatically developing a useful semantic resource for exposomics.

  11. Can complex health interventions be evaluated using routine clinical and administrative data? - a realist evaluation approach.

    Science.gov (United States)

    Riippa, Iiris; Kahilakoski, Olli-Pekka; Linna, Miika; Hietala, Minni

    2014-12-01

    Interventions aimed at improving chronic care typically consist of multiple interconnected parts, all of which are essential to the effect of the intervention. Limited attention has been paid to the use of routine clinical and administrative data in the evolution of these complex interventions. The purpose of this study is to examine the feasibility of routinely collected data when evaluating complex interventions and to demonstrate how a theory-based, realist approach to evaluation may increase the feasibility of routine data. We present a case study of evaluating a complex intervention, namely, the chronic care model (CCM), in Finnish primary health care. Issues typically faced when evaluating the effects of a complex intervention on health outcomes and resource use are identified by using routine data in a natural setting, and we apply context-mechanism-outcome (CMO) approach from the realist evaluation paradigm to improve the feasibility of using routine data in evaluating complex interventions. From an experimentalist approach that dominates the medical literature, routine data collected from a single centre offered a poor starting point for evaluating complex interventions. However, the CMO approach offered tools for identifying indicators needed to evaluate complex interventions. Applying the CMO approach can aid in a typical evaluation setting encountered by primary care managers: one in which the intervention is complex, the primary data source is routinely collected clinical and administrative data from a single centre, and in which randomization of patients into two research arms is too resource consuming to arrange. © 2014 John Wiley & Sons, Ltd.

  12. [CLINICAL EVALUATION OF THE NEW ANTISEPTIC MESHES].

    Science.gov (United States)

    Gogoladze, M; Kiladze, M; Chkhikvadze, T; Jiqia, D

    2016-12-01

    Improving the results of hernia treatment and prevention of complications became a goal of our research which included two parts - experimental and clinical. Histomorphological and bacteriological researches showed that the best result out of the 3 control groups was received in case of covering implant "Coladerm"+ with chlorhexidine. Based on the experiment results working process continued in clinics in order to test and introduce new "coladerm"+ chlorhexidine covered poliprophilene meshes into practice. For clinical illustration there were 60 patients introduced to the research who had hernioplasty procedures by different nets: I group - standard meshes+"coladerm"+chlorhexidine, 35 patients; II group - standard meshes +"coladerm", 15 patients; III group - standard meshes, 10 patients. Assessment of the wound and echo-control was done post-surgery on the 8th, 30th and 90th days. This clinical research based on the experimental results once again showed the best anti-microbe features of new antiseptic polymeric biocomposite meshes (standard meshes+"coladerm"+chlorhexidine); timely termination of regeneration and reparation processes without any post-surgery suppurative complications. We hope that new antiseptic polymeric biocomposite meshes presented by us will be successfully used in surgical practice of hernia treatment based on and supported by expermental-clinical research.

  13. The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

    Science.gov (United States)

    Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

    2016-04-01

    Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  14. A Clinical Study on Hypothyroidism

    International Nuclear Information System (INIS)

    Park, Keun Jo; Park, Sun Yang; Park, Jung Sik; Lee, Myung Chul; Koh, Chang Soon; Lee, Mun Ho

    1976-01-01

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with 131 I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of 131 I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T 4 (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T 3 RU (66.1%) and BMR (64.9%).

  15. A Clinical Study on Hypothyroidism

    Energy Technology Data Exchange (ETDEWEB)

    Park, Keun Jo; Park, Sun Yang; Park, Jung Sik; Lee, Myung Chul; Koh, Chang Soon; Lee, Mun Ho [Seoul National University College of Medicine, Seoul (Korea, Republic of)

    1976-03-15

    A clinical study was made on 263 patients of hypothyroidism among the 5,970 patients of Various thyroid diseases diagnosed and treated at the Radioisotope Clinic and Laboratory, Seoul National University Hospital from May, 1960 to Aug, 1975. The results obtained with this study are as follows: 1) The etiological classification of hypothyroidism revealed 244 cases (93%) of primary hypothyroidism and 19 cases (7%) of secondary hypothyroidism. 2) The most frequent cause of the thyroprivic primary hypothyroidism was post radioiodine therapy with 109 cases (41.4%). 3) There were 37 cases (14%) of male and 226 cases (86%) of female, showing a ratio of 1 : 6. 4) The majority of patients were between the ages of 30 and 60 with the peak incidence (87 cases, 33%) in their fourth decades of lives. 5) The major symptoms and signs were weakness (97%), edema of face and extremities (92%); Decreased Achilles tendon reflex (87%), cold intolerance (82%), gain in weight (76%), constipation (58%) and cold skin (51%). 6) The cumulative incidence of hypothyroidism in patient treated with {sup 131}I (3-8 mci) was 7.2% at first year, 33.3% at tenth year and the 50% at fourteenth year and the annual increment was 2.9%. 7) The incidence of hypothyroidism related to the numbers of {sup 131}I therapy was not linear. 8) The diagnostic compatibilities of the various tests to hypothyroidism were TSH (100%), T{sub 4} (93.8%), 24-hour-RNIU (91.5%), ATR (86.7%), T{sub 3}RU (66.1%) and BMR (64.9%).

  16. Systematic review and meta-analysis of studies evaluating diagnostic test accuracy: A practical review for clinical researchers-Part I. general guidance and tips

    International Nuclear Information System (INIS)

    Kim, Kyung Won; Choi, Sang Hyun; Huh, Jimi; Park, Seong Ho; Lee, June Young

    2015-01-01

    In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods

  17. Menses cup evaluation study.

    Science.gov (United States)

    Cheng, M; Kung, R; Hannah, M; Wilansky, D; Shime, J

    1995-09-01

    To determine whether the menses cup is well tolerated by menstruating women. Prospective descriptive clinical study. Normal human volunteers in an academic research environment. Fifty-one menstruating women recruited between June to December 1991. Each participant was provided with two menses cups and an instruction sheet. Baseline information, including age, occupation, martial status, parity, description of menstrual flow, and current method used to cope with menstrual flow was collected. Subjects were asked to describe their experience with the cup at 1-, 2-, 6-, and 12-month intervals. The proportion of women who found the cup acceptable. The cup was used by 51 subjects for a total of 159 cycles. Overall, 23 women (45%) found the cup an acceptable method for coping with menses. Among 29 (57%) women who used the cup for two or more cycles, 62% found it acceptable. The menses cup may be an acceptable method for some women for coping with menstrual flow.

  18. Clinical Leaders for the Future: Evaluation of the Early Clinical Careers Fellowship Pilot Programme

    OpenAIRE

    Pearson, Pauline; Machin, Alison; Rae, Anne

    2010-01-01

    The aim of this study was to systematically evaluate key features (contexts), activities (mechanisms) and outcomes of the Early Clinical Career Fellowships Pilot. In Scotland and across the United Kingdom (UK) the number of nurses likely to retire is set to double between 2005 and 2015 - equivalent to a quarter of all nurses. There is a need to build leadership capacity within the existing workforce in order to maintain the quality of service provision.

  19. A field study evaluation of Petrifilm™ plates as a 24-h rapid diagnostic test for clinical mastitis on a dairy farm.

    Science.gov (United States)

    Mansion-de Vries, Elisabeth Maria; Knorr, Nicole; Paduch, Jan-Hendrik; Zinke, Claudia; Hoedemaker, Martina; Krömker, Volker

    2014-03-01

    Clinical mastitis is one of the most common and expensive diseases of dairy cattle. To make an informed treatment decision, it is important to know the causative pathogen. However, no detection of bacterial growth can be made in approximately 30% of all clinical cases of mastitis. Before selecting the treatment regimen, it is important to know whether the mastitis-causing pathogen (MCP) is Gram-positive or Gram-negative. The aim of this field study was to investigate whether using two 3M Petrifilm™ products on-farm (which conveys a higher degree of sample freshness but also bears a higher risk for contamination than working in a lab) as 24-h rapid diagnostic of clinical mastitis achieved results that were comparable to the conventional microbiological diagnostic method. AerobicCount (AC)-Petrifilm™ and ColiformCount (CC)-Petrifilm™ were used to identify the total bacterial counts and Gram-negative bacteria in samples from clinical mastitis cases, respectively. Missing growth on both plates was classified as no bacterial detection. Growth only on the AC-Petrifilm™ was assessed as Gram-positive, and growth on both Petrifilm™ plates was assessed as Gram-negative bacterial growth. Additionally, milk samples were analysed by conventional microbiological diagnostic method on aesculin blood agar as a reference method. Overall, 616 samples from clinical mastitis cases were analysed. Using the reference method, Gram-positive and Gram-negative bacteria, mixed bacterial growth, contaminated samples and yeast were determined in 32.6%, 20.0%, 2.5%, 14.1% and 1.1% of the samples, respectively. In 29.7% of the samples, microbiological growth could not be identified. Using the Petrifilm™ concept, bacterial growth was detected in 59% of the culture-negative samples. The sensitivity of the Petrifilm™ for Gram-positive and Gram-negative MCP was 85.2% and 89.9%, respectively. The specificity was 75.4% for Gram-positive and 88.4% for Gram-negative MCP. For the culture

  20. Clinical evaluation of oropharyngeal dysphagia in Machado-Joseph disease

    Directory of Open Access Journals (Sweden)

    Sabrina Mello Alves Corrêa

    2010-12-01

    Full Text Available CONTEXT: In Machado-Joseph disease, poor posture, dystonia and peripheral neuropathy are extremely predisposing to oropharyngeal dysphagia, which is more commonly associated with muscular dystrophy. OBJECTIVE: To evaluate the clinical characteristics of oropharyngeal dysphagia in Machado-Joseph disease patients. METHOD: Forty individuals participated in this study, including 20 with no clinical complaints and 20 dysphagic patients with Machado-Joseph disease of clinical type 1, who were all similar in terms of gender distribution, average age, and cognitive function. The medical history of each patient was reviewed and each subject underwent a clinical evaluation of deglutition. At the end, the profile of dysphagia in patients with Machado-Joseph disease was classified according to the Severity Scale of Dysphagia, as described by O'Neil and collaborators. RESULTS: Comparison between dysphagic patients and controls did not reveal many significant differences with respect to the clinical evaluation of the oral phase of deglutition, since afflicted patients only demonstrated deficits related to the protrusion, retraction and tonus of the tongue. However, several significant differences were observed with respect to the pharyngeal phase. Dysphagic patients presented pharyngeal stasis during deglutition of liquids and solids, accompanied by coughing and/or choking as well as penetration and/or aspiration; these signs were absent in the controls. CONCLUSIONS: Oropharyngeal dysphagia is part of the Machado-Joseph disease since the first neurological manifestations. There is greater involvement of the pharyngeal phase, in relation to oral phase of the deglutition. The dysphagia of these patients is classified between mild and moderate.

  1. Clinical Evaluation of a New-Formula Shampoo for Scalp Seborrheic Dermatitis Containing Extract of Rosa centifolia Petals and Epigallocatechin Gallate: A Randomized, Double-Blind, Controlled Study

    OpenAIRE

    Kim, Yu Ri; Kim, Jeong-Hwan; Shin, Hong-Ju; Choe, Yong Beom; Ahn, Kyu Joong; Lee, Yang Won

    2014-01-01

    Background Scalp seborrheic dermatitis is a chronic type of inflammatory dermatosis that is associated with sebum secretion and proliferation of Malassezia species. Ketoconazole or zinc-pyrithione shampoos are common treatments for scalp seborrheic dermatitis. However, shampoos comprising different compounds are required to provide patients with a wider range of treatment options. Objective This study was designed to evaluate a new-formula shampoo that contains natural ingredients-including e...

  2. The Clinical Evaluation of Parkinson's Tremor

    NARCIS (Netherlands)

    Zach, H.; Dirkx, M.; Bloem, B.R.; Helmich, R.C.

    2015-01-01

    Parkinson's disease harbours many different tremors that differ in distribution, frequency, and context in which they occur. A good clinical tremor assessment is important for weighing up possible differential diagnoses of Parkinson's disease, but also to measure the severity of the tremor as a

  3. Controlled clinical studies of homeopathy.

    Science.gov (United States)

    Mathie, Robert T

    2015-10-01

    Observations about controlled clinical trials expressed by Max Haidvogl in the book Ultra High Dilution (1994) have been appraised from a perspective two decades later. The present commentary briefly examines changes in homeopathy research evidence since 1994 as regards: the published number of randomised controlled trials (RCTs), the use of individualised homeopathic intervention, the 'proven efficacy of homeopathy', and the quality of the evidence. The commentary reflects the details of RCTs that are available in a recently published literature review and by scrutiny of systematic reviews of RCTs in homeopathy. The homeopathy RCT literature grew by 309 records in the 18 years that immediately followed Haidvogl's article, with more than a doubling of the proportion that investigated individualised homeopathy. Discounting one prior publication, the entire systematic review literature on homeopathy RCTs post-dates 1994. A total of 36 condition-specific systematic reviews have been identified in the peer-reviewed literature: 16 of them reported positive, or tentatively positive, conclusions about homeopathy's clinical effectiveness; the other 20 were negative or non-conclusive. Reviews typically have been restricted in the strength of their conclusions by the low quality of the original RCT evidence. Three comprehensive systematic reviews concluded, cautiously, that homeopathy may differ from placebo; a fourth such review reached negative conclusions. A recent high-quality meta-analysis concluded that medicines prescribed in individualised homeopathic treatment may have small, specific, effects. Despite important growth in research activity since 1994, concerns about study quality limit the interpretation of available RCT data. The question whether homeopathic intervention differs from placebo awaits decisive answer. Copyright © 2015 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  4. Microneedle delivery: clinical studies and emerging medical applications.

    Science.gov (United States)

    Pettis, Ronald J; Harvey, Alfred J

    2012-03-01

    The concept of microneedle drug delivery was described three decades ago; however, effective clinical demonstration has only occurred within the past 10-15 years. Substantial progress in microneedle design and fabrication including extensive in vitro, ex vivo, and in vivo preclinical evaluation with various drugs, vaccines and other agents has transpired over the last decade. In contrast with this large volume of preclinical data, there are relatively few published microneedle clinical studies. To date, the clinical investigative focus has included testing to reduce dermal barrier properties and enhance transdermal delivery; evaluation of enhanced vaccine antigenicity, including development of the first commercial microneedle product for intradermal influenza vaccination; evaluation of altered microneedle protein pharmacokinetics and pharmacodynamics, especially for insulin; and evaluation of the pain and other perceptions associated with microneedle usage. This review summarizes the various aspects of microneedle clinical evaluation to date and identifies areas requiring further clinical evaluation.

  5. Nail disorders in children, a clinical study

    Directory of Open Access Journals (Sweden)

    Ayşe Akbaş

    2016-04-01

    Full Text Available Introduction: Aims of the study to investigate the frequency and the nature ofnail disorders in children significant clinical data is available. Nail disorders although common in children in some parts of our country. This study was carried out to document the clinical and demographic pattern of nail disorders in a dermatology outpatient clinic of a pediatric hospital in Ankara, Turkey. Material and Methods: All consecutive patients a total of 3000 children from age 0-16 were admitted to dermatology outpatient clinic of Ankara Pediatric Hematology and Oncology Education and Research Hospital during January 2011 to December 2011 were studied and retrospectively evaluated for age, gender, drug use, diseases, systemic or genetic disorders and demographic features. Diagnostic evaluation results were noted and patients were categorized for demographic features and diagnosis. Results: These 133 patients (M: F 58:75, %44 vs 56, respectively were under 16 years of age and have 17 different dermatological disorders related with nail symptoms. Fifty three of (39,8% these patient were under 2 years of age, 31 (23.3% were between 3-5 years, 30 (22.5% were between 6-11 years old, 19 of 133 (14%, 2 were between 11-16 years of age. Through all of ages and independent of gender the most etiologies of nail disorders were, onychomadesis, paronychia, onycholysis, onychomycosis and systemic nail presentation of systemic dermatosis. Conclusion: Nail disorders are different in children than in adults. In our study, the first 5 years of age was found in 53% of nail disorders. Nail disorders are uncommon but may be seen as a part of a systemic disease and may be associated with cosmetic and psychologic problem.

  6. Evaluation of clinical coding data to determine causes of critical bleeding in patients receiving massive transfusion: a bi-national, multicentre, cross-sectional study.

    Science.gov (United States)

    McQuilten, Z K; Zatta, A J; Andrianopoulos, N; Aoki, N; Stevenson, L; Badami, K G; Bird, R; Cole-Sinclair, M F; Hurn, C; Cameron, P A; Isbister, J P; Phillips, L E; Wood, E M

    2017-04-01

    To evaluate the use of routinely collected data to determine the cause(s) of critical bleeding in patients who receive massive transfusion (MT). Routinely collected data are increasingly being used to describe and evaluate transfusion practice. Chart reviews were undertaken on 10 randomly selected MT patients at 48 hospitals across Australia and New Zealand to determine the cause(s) of critical bleeding. Diagnosis-related group (DRG) and International Classification of Diseases (ICD) codes were extracted separately and used to assign each patient a cause of critical bleeding. These were compared against chart review using percentage agreement and kappa statistics. A total of 427 MT patients were included with complete ICD and DRG data for 427 (100%) and 396 (93%), respectively. Good overall agreement was found between chart review and ICD codes (78·3%; κ = 0·74, 95% CI 0·70-0·79) and only fair overall agreement with DRG (51%; κ = 0·45, 95% CI 0·40-0·50). Both ICD and DRG were sensitive and accurate for classifying obstetric haemorrhage patients (98% sensitivity and κ > 0·94). However, compared with the ICD algorithm, DRGs were less sensitive and accurate in classifying bleeding as a result of gastrointestinal haemorrhage (74% vs 8%; κ = 0·75 vs 0·1), trauma (92% vs 62%; κ = 0·78 vs 0·67), cardiac (80% vs 57%; κ = 0·79 vs 0·60) and vascular surgery (64% vs 56%; κ = 0·69 vs 0·65). Algorithms using ICD codes can determine the cause of critical bleeding in patients requiring MT with good to excellent agreement with clinical history. DRG are less suitable to determine critical bleeding causes. © 2016 British Blood Transfusion Society.

  7. Phase Ib Study of Lumretuzumab Plus Cetuximab or Erlotinib in Solid Tumor Patients and Evaluation of HER3 and Heregulin as Potential Biomarkers of Clinical Activity

    DEFF Research Database (Denmark)

    Meulendijks, Didier; Jacob, Wolfgang; Voest, Emile E

    2017-01-01

    Purpose: This study investigated the safety, clinical activity, and target-associated biomarkers of lumretuzumab, a humanized, glycoengineered, anti-HER3 monoclonal antibody (mAb), in combination with the EGFR-blocking agents erlotinib or cetuximab in patients with advanced HER3-positive carcinomas.......Experimental Design: The study included two parts: dose escalation and dose extension phases with lumretuzumab in combination with either cetuximab or erlotinib, respectively. In both parts, patients received lumretuzumab doses from 400 to 2,000 mg plus cetuximab or erlotinib according to standard posology......) in the cetuximab part and two DLTs in the erlotinib part were reported. The most frequent adverse events were gastrointestinal and skin toxicities, which were manageable. The objective response rate (ORR) was 6.1% in the cetuximab part and 4.2% in the erlotinib part. In the sqNSCLC extension cohort...

  8. Clinical evaluation of three caries removal approaches in primary teeth

    DEFF Research Database (Denmark)

    Phonghanyudh, A; Phantumvanit, P; Songpaisan, Y

    2012-01-01

    To evaluate the clinical performance and radiographic outcome of glass ionomer cement (GIC) restoration in primary molars using three caries removal techniques.......To evaluate the clinical performance and radiographic outcome of glass ionomer cement (GIC) restoration in primary molars using three caries removal techniques....

  9. Evaluating Industry Payments Among Dermatology Clinical Practice Guidelines Authors.

    Science.gov (United States)

    Checketts, Jake X; Sims, Matthew Thomas; Vassar, Matt

    2017-12-01

    It is well documented that financial conflicts of interest influence medical research and clinical practice. Prior to the Open Payments provisions of the Affordable Care Act, financial ties became apparent only through self-disclosure. The nature of financial interests has not been studied among physicians who develop dermatology clinical practice guidelines. To evaluate payments received by physicians who author dermatology clinical practice guidelines, compare disclosure statements for accuracy, determine whether pharmaceutical companies from which the authors received payments manufactured products related to the guidelines, and examine the extent to which the American Academy of Dermatology enforced their Administrative Regulations for guideline development. Three American Academy of Dermatology guidelines published from 2013 to 2016 were retrieved. Double data extraction was used to record financial payments received by 49 guideline authors using the Open Payments database. Payments received by the authors from the date of the initial literature search to the date of publication were used to evaluate disclosure statement accuracy, detail the companies providing payments, and evaluate Administrative Regulations enforcement. This study is applicable to clinical practice guideline panels drafting recommendations, physicians using clinical practice guidelines to inform patient care, and those establishing policies for guideline development. Our main outcomes are the monetary values and types of payments received by physicians who author dermatology guidelines and the accuracy of disclosure statements. Data were collected from the Open Payments database and analyzed descriptively. Of the 49 authors evaluated, 40 received at least 1 reported industry payment, 31 accepted more than $1000, 25 accepted more than $10 000, and 18 accepted more than $50 000. Financial payments amounted to a mean of $157 177 per author. The total reimbursement among the 49 authors

  10. Modified cementless total coxofemoral prosthesis: development, implantation and clinical evaluation

    Directory of Open Access Journals (Sweden)

    S.A. Arias

    2013-12-01

    Full Text Available The aim of this study was to modify canine coxofemoral prostheses and the clinical evaluation of the implantation. Fifteen canine hips and femora of cadavers were used in order to study the surface points of modification in prostheses and develop a perforation guide. Femoral stems and acetabular components were perforated and coated with biphasic calcium phosphate layer. Twelve young adult male mongrel dogs were implanted with coxofemoral prostheses. Six were operated upon and implanted with cemented canine modular hip prostheses, establishing the control group. The remaining six were implanted with a novel design of cementless porous tricalcic phosphate-hydroxyapatite coated hip prostheses. Clinical and orthopedic performance, complications, and thigh muscular hypotrophy were assessed up to the 120th post-operatory day. After 120 days, animals with cementless prostheses had similar clinical and orthopedic performance compared to the cemented group despite the increased pain thigh hypotrophy. Animals that underwent cementless hip prosthesis evidenced more pain, compared to animals with cemented hip prosthesis that required longer recuperation time. No luxations, two fractures and two isquiatic neurapraxies were identified in the course of the study. Using both the cemented and the bioactive coated cementless model were suitable to dogs, showing clinical satisfactory results. Osseointegration and biological fixation were observed in the animals with the modified cementless hip prosthesis.

  11. The Maastricht Clinical Teaching Questionnaire (MCTQ) as a valid and reliable instrument for the evaluation of clinical teachers.

    Science.gov (United States)

    Stalmeijer, Renée E; Dolmans, Diana H J M; Wolfhagen, Ineke H A P; Muijtjens, Arno M M; Scherpbier, Albert J J A

    2010-11-01

    Clinical teaching's importance in the medical curriculum has led to increased interest in its evaluation. Instruments for evaluating clinical teaching must be theory based, reliable, and valid. The Maastricht Clinical Teaching Questionnaire (MCTQ), based on the theoretical constructs of cognitive apprenticeship, elicits evaluations of individual clinical teachers' performance at the workplace. The authors investigated its construct validity and reliability, and they used the underlying factors to test a causal model representing effective clinical teaching. Between March 2007 and December 2008, the authors asked students who had completed clerkship rotations in different departments of two teaching hospitals to use the MCTQ to evaluate their clinical teachers. To establish construct validity, the authors performed a confirmatory factor analysis of the evaluation data, and they estimated reliability by calculating the generalizability coefficient and standard error measurement. Finally, to test a model of the factors, they fitted a structural linear model to the data. Confirmatory factor analysis yielded a five-factor model which fit the data well. Generalizability studies indicated that 7 to 10 student ratings can produce reliable ratings of individual teachers. The hypothesized structural linear model underlined the central roles played by modeling and coaching (mediated by articulation). The MCTQ is a valid and reliable evaluation instrument, thereby demonstrating the usefulness of the cognitive apprenticeship concept for clinical teaching during clerkships. Furthermore, a valuable model of clinical teaching emerged, highlighting modeling, coaching, and stimulating students' articulation and exploration as crucial to effective teaching at the clinical workplace.

  12. Evaluation of medication treatment for Alzheimer's disease on clinical evidence

    Directory of Open Access Journals (Sweden)

    Meng-qiu LI

    2014-03-01

    Full Text Available Objective To formulate the best treatment plan for Alzheimer's disease patients by evaluating the therapeutic efficacy and side effect of various evidence-based programs. Methods Alzheimer's disease, donepezil, rivastigmine, galantamine, memantine, rosiglitazone, etc. were defined as retrieval words. PubMed, Cochrane Library, Wanfang Data and China National Knowledge Infrastructure (CNKI databases were used with applying of manual searching. Systematic reviews, randomized controlled trials (RCT, controlled clinical trials and case-observation studies were collected and evaluated by Jadad Scale. Results After screening, 33 selected resources included 14 systematic reviews, 14 randomized controlled trials, 4 controlled clinical trials and 1 case-observation study. According to Jadad Scale, total 28 articles were evaluated to be high quality (12 with score 4, 10 score 5, 6 score 7, and 5 were low quality with score 3. It was summarized as follows: 1 Alzheimer's disease is a progressive neurodegenerative disease for which no cure exists. To date, only symptomatic treatments with cholinesterase inhibitors (donepezil, rivastigmine, galantamine and an N-methyl-D-aspartate (NMDA receptor noncompetitive antagonist (memantine, are effective and well tolerated to counterbalance the neurotransmitter disturbance, but cannot limit or impact on disease progression. 2 Disease modifying drug is an potential agent, with persistent effect on slowing the progression of structural damage, and can be detected even after withdrawing the treatment. Many types of disease modifying drugs are undergoing clinical trials. Conclusions Using evidence-based medicine methods can provide best clinical evidence on Alzheimer's disease treatment. doi: 10.3969/j.issn.1672-6731.2014.03.009

  13. Determination of spondylolisthesis in low back pain by clinical evaluation.

    Science.gov (United States)

    Kalpakcioglu, Banu; Altinbilek, Turgay; Senel, Kazim

    2009-01-01

    Current guides recommend to evaluate the patients with low back pain complaints with initial clinical assessment and history, and to utilize radiological or other imaging technics, in case of possible diagnosis. The aim of this study was to compare the findings of radiological and clinical assessment, and validate the reliability of spondylolisthesis diagnosed with clinical assessment. This study is conducted on 100 patients with, and 30 patients without (control group) radiological diagnosis of spondylolisthesis, who had applied to Department of Physical Therapy and Rehabilitation, Haydarpasa Numune Hospital with low back pain complaints in one and a half year. Clinic assessment was consisted of 20 parameters including examinations of motor system such as, sign of slipping observed on palpation and inspection, extension of trunk and increase in lumbar lordosis. Antero-posterior, lateral, oblique and lateral flexion/extension radiographies were used for radiological assessment. Slipping degree and lumbar lordosis angle were measured. Women/men patients ratio was 91/9 in spondylolisthesis group and 22/8 in control group. Age of 69% of patients were 50 and over. In both groups, sciatalgia was observed in more than half of the patients, and no significant difference was detected in localization (p > 0.05). In clinical assessment, weak and drooping abdominal wall, paravertebral muscle hypertrophy, increase in lumbar lordosis, sign of slipping observed on palpation and inspection, hamstring muscle spasm, pain during lateral trunk flexion-extension tasks and during double leg raising task were found to be positively correlated with radiological assesment (p < 0.05). In our study, a systematic clinical assessment was proved to be useful in determination of possible spondylolisthesis cases. Radiological assessments are required in order to make the diagnosis clear and to determine the grade and prognosis of spondylolisthesis. Advanced imaging techniques like MRI and CT

  14. A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study.

    Science.gov (United States)

    Littlewood, Chris; Ashton, Jon; Mawson, Sue; May, Stephen; Walters, Stephen

    2012-04-30

    Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff) are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability.Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise) in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance. A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist's.An economic analysis will be conducted from an NHS and Personal Social Services perspective to evaluate

  15. A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study

    Directory of Open Access Journals (Sweden)

    Littlewood Chris

    2012-04-01

    Full Text Available Abstract Background Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability. Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance. Methods/Design A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist’s. An economic analysis will be conducted from an

  16. Clinical and laboratory evaluation of adrenal dysfunction

    International Nuclear Information System (INIS)

    Ashkar, F.S.; Fishman, L.M.

    1983-01-01

    Because of their special physical and chemical properties, the adrenal secretory products were among the first hormonal substances to be measured by methods other than bioassay. Over the past several years, the development of sensitive and specific methods of hormone assay dependent on the use of radionuclides has revolutionized investigative and clinical endocrinology. While the capacity of defining most abnormalities of adrenal function antedates hormone measurement and adrenal imaging utilizing radioisotopes, the availability of such methods has greatly facilitated and made more precise the diagnostic approach to patients with suspected adrenal dysfunction. As an example of how clinical and laboratory considerations can be integrated into a rational approach to the diagnosis of adrenal disease, the problem of suspected adrenal hyperfunction is analyzed in light of current understanding of its pathophysiology. Reflection demonstrates that suspected primary aldosteronism and adrenal insufficiency are equally amenable to such an approach

  17. Clinical evaluation of hypoxic cell sensitizer (Misonidazole)

    Energy Technology Data Exchange (ETDEWEB)

    Asakawa, Hiroshi (Miyagi Prefectural Adult Disease Center, Natori (Japan)); Watarai, Jiro; Hoshino, Toshiaki

    1984-06-01

    Clinical effectiveness and toxicity of Misonidazole were analyzed and discussed in 22 cases of carcinoma of uterine cervix, 17 cases of esophageal cancer and 11 with other malignancies treated by radiation. By clinical and histologic examination in the controlled trial, it was shown that radiation response of tumor was slightly sensitized in the treated group with this drug, compared with that in the control group. It was confirmed that there was no significant difference between radiation response of tumor in both groups. Peripheral neuropathy was a complication in 10% and toxicodermatitis in 12% even if the total dose administered was below 10 g/m/sup 2/. From these results, it was strongly suggested that this drug is not suitable in combination with simple fractionated irradiation as a hypoxic cell sensitizer.

  18. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: Experimental study of periarticular injections

    International Nuclear Information System (INIS)

    Meloni, F.; Milia, F.; Cavazzuti, M.; Doria, C.; Lisai, P.; Profili, S.; Meloni, G.B.

    2008-01-01

    Purpose: The purpose of this study was to examine the effect of periarticular injection of hyaluronate into shoulders with supraspinatus tendinosis under echographic guide. Methods and materials: The subjects were 56 patients with clinical, echographic and magnetic resonance diagnosis of supraspinatus tendinosis. They were divided in two groups by random sampling; 28 patients were assigned in SH group (sodium hyaluronate) and 28 patients in SC group (sodium chloride). The test drug was 20 mg sodium hyaluronate (2 ml, Hyalgan, Fidia SpA, Abano T., P.M. 500-700.000, 20 mg/2 ml). Results: Preliminary results showed that sodium hyaluronate presented the highest efficacy in the improvement of clinical symptoms and recovery of functional status in patients with supraspinatus tendinosis in fact the mean V.A.S. score (Visual Analogue Scale) at 1 month after the end of the infiltrative cycle was 8.0 in the SC group vs. 2.8 in SH group and these numerical data were substantially unchanged also after 3 and 4 months. Conclusion: Hyaluronate injection under echographic guide should be use not only as a lubricant but also to prevent articular cartilage degeneration and cover and protect the articular cartilage; indeed sodium hyaluronate can decrease inflammatory joint process

  19. A child's nightmare. Mum comes and comforts her child. Attachment evaluation as a guide in the assessment and treatment in a clinical case study

    Directory of Open Access Journals (Sweden)

    Silvia eSalcuni

    2014-08-01

    Full Text Available There is a gap between proposed theoretical attachment theory frameworks, measures of attachment in the assessment phase and their relationship with changes in outcome after a psychodynamic oriented psychotherapy. Based on a clinical case study of a young woman with Panic Attack Disorder, this paper examined psychotherapy outcome findings comparing initial and post-treatment assessments, according to the mental functioning in S and M-axis of the Psychodynamic Diagnostic Manual (PDM. Treatment planning and post-treatment changes were described with the main aim to illustrate from a clinical point of view why a psycho-dynamic approach, with specific attention to an attachment theory stance, was considered the treatment of choice for this patient. The Symptom Check List 90 Revised (SCL-90-R and the Shedler-Westen Assessment Procedure (SWAP–200 were administered to detect patient’s symptomatic perception and clinician’s diagnostic points of view, respectively; the Adult Attachment Interview (AAI and the Adult Attachment Projective Picture System (AAP were also administered as to pay attention to patient’s unconscious internal organization and changes in defense processes. A qualitative description of how the treatment unfolded was included. Findings highlight the important contribution of attachment theory in a 22-month psychodynamic psychotherapy framework, promoting resolution of patient’s symptoms and adjustment.

  20. Results of a multicenter prospective clinical study in Japan for evaluating efficacy and safety of desensitization protocol based on rituximab in ABO-incompatible kidney transplantation.

    Science.gov (United States)

    Takahashi, Kota; Saito, Kazuhide; Takahara, Shiro; Fuchinoue, Shohei; Yagisawa, Takashi; Aikawa, Atsushi; Watarai, Yoshihiko; Yoshimura, Norio; Tanabe, Kazunari; Morozumi, Kunio; Shimazu, Motohide

    2017-08-01

    Deceased organ donations are rare in Japan, with most kidney transplants performed from a limited number of living donors. Researchers have thus developed highly successful ABO-incompatible transplantation procedures, emphasizing preoperative desensitization and postoperative immunosuppression. A recent open-label, single-arm, multicenter clinical study prospectively examined the efficacy and safety of rituximab/mycophenolate mofetil desensitization in ABO-incompatible kidney transplantation without splenectomy. Mycophenolate mofetil and low dose steroid were started 28 days pretransplant, followed by two doses of rituximab 375 mg/m 2 at day -14 and day -1, and postoperative immunosuppression with tacrolimus or ciclosporin and basiliximab. The primary endpoint was the non-occurrence rate of acute antibody-mediated rejection. Patient survival and graft survival were monitored for 1 year posttransplant. Eighteen patients received rituximab and underwent ABO-incompatible kidney transplantation. CD19-positive peripheral B cell count decreased rapidly after the first rituximab infusion and recovered gradually after week 36. The desensitization protocol was tolerable, and most rituximab-related infusion reactions were mild. No anti-A/B antibody-mediated rejection occurred with this series. One patient developed anti-HLA antibody-mediated rejection (Banff 07 type II) on day 2, which was successfully managed. Patient and graft survival were both 100 % after 1 year. Our desensitization protocol was confirmed to be clinically effective and with acceptable toxicities for ABO-I-KTx (University Hospital Medical Information Network Registration Number: UMIN000006635).

  1. Radiological and clinical evaluation of colorectal cancer

    International Nuclear Information System (INIS)

    Shin, O. J.; Chin, S. Y.; Lee, K. S.; Park, S. S.

    1982-01-01

    One hundred thirty two cases of the pathologically proven colorectal cancer at Korea Atomic Energy Research Institute Hospital in the period from January 1973 to June 1980 were analyzed radiologically and clinically. The results were as follows: 1. The colorectal cancer was prevalent in rectosigmoid area and in the fourth to seventh decade of life. 2. The clinical pictures were classified into two groups. The one was rectosigmoid cancer with bowel habit changes. The other was one with no specific symptoms or signs. The clinical pictures of the right colon cancer were rather indirected, chronic and systemic than those of the left one. 3. The roentgenological findings were classified into two groups. The one was rectum and left colon cancer with symmetrical annular narrowing and the other showed trumpet-like proximal dilatation. 4. The most frequent complication was intestinal obstruction. 5. The majority of colorectal cancer was adenocarcinoma. The squamous cell carcinoma and atypical cell carcinoma were most prevalent in rectum, but malignantly lymphoma often occurred in right colon. The rarest colorectal cancer was atypical cell carcinoma in rectum

  2. Evaluation of peripheral enthesitis in spondyloarthritis: Ultrasonography versus clinical examination

    Directory of Open Access Journals (Sweden)

    Anupam Wakhlu

    2017-01-01

    Full Text Available Background: Enthesitis is an important feature of spondyloarthritis but may often be subclinical. Data is sparse, especially from India, on the ultrasonography (USG detection of enthesitis in these patients. The present study aimed to find the prevalence and pattern of entheseal involvement assessed clinically and by USG. Methods: Fifty-two spondyloarthritis, 26 rheumatoid arthritis, and 26 healthy controls were evaluated for enthesitis by clinical examination and by USG using 2014 OMERACT consensus group definitions at bilateral Achilles insertion on the calcaneus, plantar fascia attachment on the calcaneus, quadriceps tendon insertion on the patella, patellar tendon origin from the inferior pole of the patella, and patellar tendon insertion on the tibial tuberosity. At least one ultrasonographic finding at any of the above sites was considered positive for enthesitis. Results: The number of entheseal sites screened in spondyloarthritis patients was 520 and 260 each in rheumatoid arthritis and healthy controls. USG (sensitivity - 94.2% was better in detecting enthesitis than clinical examination (sensitivity - 69.2%. Clinical examination was highly specific (100% compared to USG (55.7% in differentiating from rheumatoid arthritis and healthy controls. USG alone without clinical findings was positive at 23.8% of sites while clinical examination alone without USG findings was positive at 5.2% of sites. Frequency of enthesitis in rheumatoid arthritis was not more than healthy controls (6.1% vs. 8.1%, respectively and was much less than spondyloarthritis (34%. Conclusion: USG is a good screening tool for detection of enthesitis but cannot replace clinical examination completely.

  3. Cross-system evaluation of clinical trial search engines.

    Science.gov (United States)

    Jiang, Silis Y; Weng, Chunhua

    2014-01-01

    Clinical trials are fundamental to the advancement of medicine but constantly face recruitment difficulties. Various clinical trial search engines have been designed to help health consumers identify trials for which they may be eligible. Unfortunately, knowledge of the usefulness and usability of their designs remains scarce. In this study, we used mixed methods, including time-motion analysis, think-aloud protocol, and survey, to evaluate five popular clinical trial search engines with 11 users. Differences in user preferences and time spent on each system were observed and correlated with user characteristics. In general, searching for applicable trials using these systems is a cognitively demanding task. Our results show that user perceptions of these systems are multifactorial. The survey indicated eTACTS being the generally preferred system, but this finding did not persist among all mixed methods. This study confirms the value of mixed-methods for a comprehensive system evaluation. Future system designers must be aware that different users groups expect different functionalities.

  4. Evaluation of esophageal motor function in clinical practice.

    Science.gov (United States)

    Gyawali, C P; Bredenoord, A J; Conklin, J L; Fox, M; Pandolfino, J E; Peters, J H; Roman, S; Staiano, A; Vaezi, M F

    2013-02-01

    Esophageal motor function is highly coordinated between central and enteric nervous systems and the esophageal musculature, which consists of proximal skeletal and distal smooth muscle in three functional regions, the upper and lower esophageal sphincters, and the esophageal body. While upper endoscopy is useful in evaluating for structural disorders of the esophagus, barium esophagography, radionuclide transit studies, and esophageal intraluminal impedance evaluate esophageal transit and partially assess motor function. However, esophageal manometry is the test of choice for the evaluation of esophageal motor function. In recent years, high-resolution manometry (HRM) has streamlined the process of acquisition and display of esophageal pressure data, while uncovering hitherto unrecognized esophageal physiologic mechanisms and pathophysiologic patterns. New algorithms have been devised for analysis and reporting of esophageal pressure topography from HRM. The clinical value of HRM extends to the pediatric population, and complements preoperative evaluation prior to foregut surgery. Provocative maneuvers during HRM may add to the assessment of esophageal motor function. The addition of impedance to HRM provides bolus transit data, but impact on clinical management remains unclear. Emerging techniques such as 3-D HRM and impedance planimetry show promise in the assessment of esophageal sphincter function and esophageal biomechanics. © 2013 Blackwell Publishing Ltd.

  5. How valid are claims for synergy in published clinical studies?

    Science.gov (United States)

    Ocana, A; Amir, E; Yeung, C; Seruga, B; Tannock, I F

    2012-08-01

    Clinical trials evaluating drug combinations are often stimulated by claims of synergistic interactions in preclinical models. Overuse or misuse of the term synergy could lead to poorly designed clinical studies. We searched PubMed using the terms 'synergy' or 'synergistic' and 'cancer' to select articles published between 2006 and 2010. Eligible studies were those that referred to synergy in preclinical studies to justify a drug combination evaluated in a clinical trial. Eighty-six clinical articles met eligibility criteria and 132 preclinical articles were cited in them. Most of the clinical studies were phase I (43%) or phase II trials (56%). Appropriate methods to evaluate synergy in preclinical studies included isobologram analysis in 18 studies (13.6%) and median effect in 10 studies (7.6%). Only 26 studies using animal models (39%) attempted to evaluate therapeutic index. There was no association between the result of the clinical trial and the use of an appropriate method to evaluate synergy (P=0.25, chi-squared test). Synergy is cited frequently in phase I and phase II studies to justify the evaluation of a specific drug combination. Inappropriate methods for evaluation of synergy and poor assessment of therapeutic index have been used in most preclinical articles.

  6. Clinical evaluation of the dynamic observing tonometer.

    Science.gov (United States)

    Morgan, Andrew J; Hosking, Sarah L; Salmon, John F

    2002-08-01

    The Dynamic Observing Tonometer (SmartLens, Ophthalmic Development Company AG, Zürich, Switzerland) is a diagnostic contact lens that allows continuous measurement of intraocular pressure, in addition to providing the investigator with a view of the posterior pole and anterior chamber angle. The purpose of this study was to determine the accuracy of this tonometer and the repeatability of the intraocular pressure measurements. The intraocular pressure was measured by Goldmann applanation tonometry in one randomly chosen eye of 40 subjects (median age 66 years, range 21-77 years). The intraocular pressure, pulse amplitude and 10-second continuous tonometric recordings were then taken using the Dynamic Observing Tonometer and a pneumatonometer. Accuracy was determined by calculating the mean bias and 95% limits of agreement of measurements made with the Dynamic Observing Tonometer against measurements made with the Goldmann and pneumatonometer. Repeatability was evaluated by calculating the differences between pairs of repeated measurements against the mean value and by calculating reliability coefficients. Intraocular pressure measurements made with the Dynamic Observing Tonometer had a mean bias of +2.1 mm Hg (95% limits of agreement: -4.0 to +8.2 mm Hg) compared with Goldmann tonometry. There was a reasonable correlation between Goldmann and Dynamic Observing Tonometer intraocular pressure readings (r = 0.78, P Tonometer was found to have a mean bias of +0.4 mm Hg (95% limits of agreement: -1.6 to +2.3 mm Hg) compared with the pneumatonometer (r = 0.78, P Tonometer reading was on average 0.4 mm Hg higher than the second (95% limits of agreement: -3.8 to +4.6 mm Hg) with a coefficient of reliability of 0.91. For pulse amplitude readings, the first reading was on average 0.1 mm Hg lower than the second (95% limits of agreement: -1.4 to +1.2 mm Hg) with a coefficient of reliability of 0.90. Intraocular pressure measurements taken with the Dynamic Observing Tonometer

  7. Clinical evaluation of radioisotope examination in oncology

    Energy Technology Data Exchange (ETDEWEB)

    Yasukochi, H [National Konodai Hospital (Japan)

    1979-07-01

    Although many approaches are tried for the diagnoses of malignant tumor, radiological examinations act surely main parts. Among the radiological examinations, radioisotope techniques are not well evaluated instead of their usefulness in this field. The reason may depend on the complexity and difficulty in legal limitations, however, the lack of knowledge in this field is also a main reason. In this paper, the present status of the evaluation of radioisotope techniques is discussed in selected region of the body and some characteristic cases are demonstrated.

  8. Evaluation of vitamin B 12 deficiency in various clinical condition

    International Nuclear Information System (INIS)

    Baig, J.A.; Alam, J.M.; Kazmi, T.; Waseem, S.; Hussain, A.; Arif, S.; Shaheen, R.; Sultana, I.

    2010-01-01

    Low levels of vitamin B 12 have been associated with several clinical conditions. However no single symptom or group of symptoms can be made responsible. Reported causes of deficiency among older population are hematologic or neurological, followed by gastrointestinal and possibly vascular symptoms. The present prospective observational study was, hence, initiated to evaluate the underlying clinical condition or symptoms associated with vitamin B12 deficiency. The study was prospective observational and carried out on 121 patients (males, n=63 and females, n=58) for the period from January 1, 2004 to January 24, 2007. Age ranges were between 16 - 70 years, and categorized as > 60 yrs and < 60 years. All blood parameters were analyzed by standardized methods on automated analyzers. The deficiency was found to be more prevalent in males and increased from 52.06% to 58.10% in individuals with vitamin B12 <150 pg/ml. Mal nourishment was noted among the most subjects and weakness and anemia were frequent clinical findings (35.55%, n=43, 14%, n=51). Other clinical conditions were neuropsychiatric. Whereas less frequent findings were paraesthesia and gastrointestinal symptoms. Hypertension was more prevalent in vitamin B12 deficient individuals followed by diabetes, dementia, stroke, ischemic heart disease and Parkinson's disease. (author)

  9. Using mixed methods evaluation to assess the feasibility of online clinical training in evidence based interventions: a case study of cognitive behavioural treatment for low back pain.

    Science.gov (United States)

    Richmond, Helen; Hall, Amanda M; Hansen, Zara; Williamson, Esther; Davies, David; Lamb, Sarah E

    2016-06-18

    Cognitive behavioural (CB) approaches are effective in the management of non-specific low back pain (LBP). We developed the CB Back Skills Training programme (BeST) and previously provided evidence of clinical and cost effectiveness in a large pragmatic trial. However, practice change is challenged by a lack of treatment guidance and training for clinicians. We aimed to explore the feasibility and acceptability of an online programme (iBeST) for providing training in a CB approach. This mixed methods study comprised an individually randomised controlled trial of 35 physiotherapists and an interview study of 8 physiotherapists. Participants were recruited from 8 National Health Service departments in England and allocated by a computer generated randomisation list to receive iBeST (n = 16) or a face-to-face workshop (n = 19). Knowledge (of a CB approach), clinical skills (unblinded assessment of CB skills in practice), self-efficacy (reported confidence in using new skills), attitudes (towards LBP management), and satisfaction were assessed after training. Engagement with iBeST was assessed with user analytics. Interviews explored acceptability and experiences with iBeST. Data sets were analysed independently and jointly interpreted. Fifteen (94 %) participants in the iBeST group and 16 (84 %) participants in the workshop group provided data immediately after training. We observed similar scores on knowledge (MD (95 % CI): 0.97 (-1.33, 3.26)), and self-efficacy to deliver the majority of the programme (MD (95 % CI) 0.25 (-1.7; 0.7)). However, the workshop group showed greater reduction in biomedical attitudes to LBP management (MD (95 % CI): -7.43 (-10.97, -3.89)). Clinical skills were assessed in 5 (33 %) iBeST participants and 7 (38 %) workshop participants within 6 months of training and were similar between groups (MD (95 % CI): 0.17(-0.2; 0.54)). Interviews highlighted that while initially sceptical, participants found iBeST acceptable. A number

  10. Evaluation of leak current of clinical electrometers

    International Nuclear Information System (INIS)

    Lopez G, W.; Campos, X.

    2002-01-01

    The present work shows the evaluation of two electrometers model Victoreen used in radiotherapy. The performance of the electrometers was proven using a source of current, built inside the work frame arcal 34, and using like reference the norm iec 60371. The results of the tests of leakage, displacement of the zero and linealty of the electrometers are presented

  11. Prevalence of Comorbidities in Rheumatoid Arthritis and Evaluation of Their Monitoring in Clinical Practice: The Spanish Cohort of the COMORA Study.

    Science.gov (United States)

    Balsa, Alejandro; Lojo-Oliveira, Leticia; Alperi-López, Mercedes; García-Manrique, María; Ordóñez-Cañizares, Carmen; Pérez, Lorena; Ruiz-Esquide, Virginia; Corrales, Alfonso; Narváez, Javier; Rey-Rey, José; Rodríguez-Lozano, Carlos; Ojeda, Soledad; Muñoz-Fernández, Santiago; Nolla, Joan M; García-Torrón, José; Gamero, Fernando; García-Vicuña, Rosario; Hernández-Cruz, Blanca; Campos, José; Rosas, José; García-Llorente, José Francisco; Gómez-Centeno, Antonio; Cáliz, Rafael; Sanmartí, Raimon; Bermúdez, Alberto; Abasolo-Alcázar, Lydia; Fernández-Nebro, Antonio; Rodríguez-Rodríguez, Luis; Marras, Carlos; González-Gay, Miguel Ángel; Hmamouchi, Ihsane; Martín-Mola, Emilio

    2017-07-12

    To describe the prevalence of comorbidities in patients with RA in Spain and discuss their management and implications using data from the Spanish cohort of the multinational study on COMOrbidities in Rheumatoid Arthritis (COMORA). This is a national sub-analysis of the COMORA study. We studied the demographics and disease characteristics of 200 adults patients diagnosed with RA (1987 ACR), and routine practices for screening and preventing the following selected comorbidities: cardiovascular, infections, cancer, gastrointestinal, pulmonary, osteoporosis and depression. Patients had a mean age of 58 years and a mean RA duration of 10 years. Mean DAS28 score was 3.3 and approximately 25% of patients were in remission (DAS28 20% (51%), hypercholesterolemia (46%) or hypertension (41%) and smoking (25%) were the most common CV risk factors. For prostate, colon and skin cancers, only 9%, 10% and 18% of patients, respectively, were optimally monitored. Infections were also inadequately managed, with 7% and 17% of patients vaccinated against influenza and pneumococcal, respectively, as was osteoporosis, with 47% of patients supplemented with vitamin D and 56% with a bone densitometry performed. In Spain, the prevalence of comorbidities and CV risk factors in RA patients with established and advanced disease is relatively high, and their management in clinical daily practice remains suboptimal. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

  12. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India.

    Science.gov (United States)

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  13. A comparative evaluation of freeze dried bone allograft and decalcified freeze dried bone allograft in the treatment of intrabony defects: A clinical and radiographic study

    Directory of Open Access Journals (Sweden)

    Rajat Gothi

    2015-01-01

    Full Text Available Background: Ideal graft material for regenerative procedures is autogenous bone graft but the major disadvantage with this graft is the need for a secondary surgical site to procure donor material and the frequent lack of intraoral donor site to obtain sufficient quantities of autogenous bone for multiple or deep osseous defects. Hence, to overcome these disadvantages, bone allografts were developed as an alternative source of graft material. Materials and Methods: In 10 patients with chronic periodontitis, 20 bilateral infrabony defects were treated with freeze dried bone allograft (FDBA-Group A and decalcified freeze dried bone allograft (DFDBA-Group B. Clinical and radiographic parameters were assessed preoperatively and at 3 months and 6 months postoperatively. Data thus obtained was subjected to statistical analysis. Results: Significant improvement in the reduction in probing depth and relative attachment level (RAL from the baseline to 3 months to baseline to 6 months in group A and group B, which was statistically significant but no statistically significant reduction was seen between 3 months and 6 months. On inter-group comparison, no significant differences were observed at all-time points. In adjunct to the probing depth and RAL, the radiographic area of the defect showed a similar trend in intra-group comparison and no significant difference was seen on inter-group comparison at all-time points. Conclusions: Within the limitations of the current study, it can be concluded that DFDBA did not show any improvement in the clinical and radiographic parameters in the treatment of the intrabony defects as compared to FDBA.

  14. Job-sharing a clinical teacher's position: an evaluation.

    Science.gov (United States)

    Williams, S; Murphy, L

    1994-01-01

    The aim of this study was to evaluate the effects on staff of having two teachers share one clinical teaching position in their intensive care unit (ICU). Three, six and 12 months after the job-sharing arrangement was initiated, an 11 item questionnaire was distributed to 26 students in post-registration critical care courses, 41 clinical staff in ICU and 9 RN-managers with responsibilities for the unit. The overall response rate to the three questionnaires was 58%. All groups agreed that job-sharing was a viable alternative to full-time work. Three months after the shared position was initiated, there was uncertainty about the consistency of the teachers' performance and the adequacy of communication between them. Nine months later, there was a high level of positive responses to all areas of the teachers' performance. Most respondents felt they could approach either teacher and that more diverse ideas were generated by having two people in the teaching position.

  15. Evaluation of RxNorm for Medication Clinical Decision Support.

    Science.gov (United States)

    Freimuth, Robert R; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G

    2014-01-01

    We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS.

  16. A Model for Evaluating Student Clinical Psychomotor Skills.

    Science.gov (United States)

    And Others; Fiel, Nicholas J.

    1979-01-01

    A long-range plan to evaluate medical students' physical examination skills was undertaken at the Ingham Family Medical Clinic at Michigan State University. The development of the psychomotor skills evaluation model to evaluate the skill of blood pressure measurement, tests of the model's reliability, and the use of the model are described. (JMD)

  17. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study

    Directory of Open Access Journals (Sweden)

    Adit Srivastava

    2015-01-01

    Full Text Available The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base for the treatment of oral submucous fibrosis (OSMF. Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF.

  18. Feasibility study to assess clinical applications of 3-T cine MRI coupled with synchronous audio recording during speech in evaluation of velopharyngeal insufficiency in children

    Energy Technology Data Exchange (ETDEWEB)

    Sagar, Pallavi; Nimkin, Katherine [Massachusetts General Hospital, Department of Radiology, Division of Pediatric Radiology, Boston, MA (United States)

    2014-08-16

    In the past decade, there has been increased utilization of magnetic resonance imaging (MRI) in evaluating and understanding velopharyngeal insufficiency (VPI). To our knowledge, none of the prior studies with MRI has simultaneously linked the audio recordings of speech during cine MRI acquisition with the corresponding images and created a video for evaluating VPI. To develop an MRI protocol with static and cine sequences during phonation to evaluate for VPI in children and compare the findings to nasopharyngoscopy and videofluoroscopy. Five children, ages 8-16 years, with known VPI, who had previously undergone nasopharyngoscopy and videofluoroscopy, were included. MRI examination was performed on a 3-T Siemens scanner. Anatomical data was obtained using an isotropic T2-weighted 3-D SPACE sequence with multiplanar reformation capability. Dynamic data was obtained using 2-D FLASH cine sequences of the airway in three imaging planes during phonation. Audio recordings were captured by a MRI compatible optical microphone. All five cases had MRI and nasopharyngoscopy and four had videofluoroscopy performed. VPI was identified by MRI in all five patients. The location and severity of the velopharyngeal gap, closure pattern, velar size and shape and levator veli palatini (LVP) muscle were identified in all patients. MRI was superior in visualizing the integrity of the LVP muscle. MRI was unable to identify hemipalatal weakness in one case. In a case of stress-induced VPI, occurring only during clarinet playing, cine MRI demonstrated discordant findings of a velopharyngeal gap during phonatory tasks but not with instrument playing. Overall, there was satisfactory correlation among MRI, nasopharyngoscopy and videofluoroscopy findings. Cine MRI of the airway during speech is a noninvasive, well-tolerated diagnostic imaging tool that has the potential to serve as a guide prior to and after surgical correction of VPI. MRI provided superior anatomical detail of the levator

  19. Feasibility study to assess clinical applications of 3-T cine MRI coupled with synchronous audio recording during speech in evaluation of velopharyngeal insufficiency in children.

    Science.gov (United States)

    Sagar, Pallavi; Nimkin, Katherine

    2015-02-01

    In the past decade, there has been increased utilization of magnetic resonance imaging (MRI) in evaluating and understanding velopharyngeal insufficiency (VPI). To our knowledge, none of the prior studies with MRI has simultaneously linked the audio recordings of speech during cine MRI acquisition with the corresponding images and created a video for evaluating VPI. To develop an MRI protocol with static and cine sequences during phonation to evaluate for VPI in children and compare the findings to nasopharyngoscopy and videofluoroscopy. Five children, ages 8-16 years, with known VPI, who had previously undergone nasopharyngoscopy and videofluoroscopy, were included. MRI examination was performed on a 3-T Siemens scanner. Anatomical data was obtained using an isotropic T2-weighted 3-D SPACE sequence with multiplanar reformation capability. Dynamic data was obtained using 2-D FLASH cine sequences of the airway in three imaging planes during phonation. Audio recordings were captured by a MRI compatible optical microphone. All five cases had MRI and nasopharyngoscopy and four had videofluoroscopy performed. VPI was identified by MRI in all five patients. The location and severity of the velopharyngeal gap, closure pattern, velar size and shape and levator veli palatini (LVP) muscle were identified in all patients. MRI was superior in visualizing the integrity of the LVP muscle. MRI was unable to identify hemipalatal weakness in one case. In a case of stress-induced VPI, occurring only during clarinet playing, cine MRI demonstrated discordant findings of a velopharyngeal gap during phonatory tasks but not with instrument playing. Overall, there was satisfactory correlation among MRI, nasopharyngoscopy and videofluoroscopy findings. Cine MRI of the airway during speech is a noninvasive, well-tolerated diagnostic imaging tool that has the potential to serve as a guide prior to and after surgical correction of VPI. MRI provided superior anatomical detail of the levator

  20. Feasibility study to assess clinical applications of 3-T cine MRI coupled with synchronous audio recording during speech in evaluation of velopharyngeal insufficiency in children

    International Nuclear Information System (INIS)

    Sagar, Pallavi; Nimkin, Katherine

    2015-01-01

    In the past decade, there has been increased utilization of magnetic resonance imaging (MRI) in evaluating and understanding velopharyngeal insufficiency (VPI). To our knowledge, none of the prior studies with MRI has simultaneously linked the audio recordings of speech during cine MRI acquisition with the corresponding images and created a video for evaluating VPI. To develop an MRI protocol with static and cine sequences during phonation to evaluate for VPI in children and compare the findings to nasopharyngoscopy and videofluoroscopy. Five children, ages 8-16 years, with known VPI, who had previously undergone nasopharyngoscopy and videofluoroscopy, were included. MRI examination was performed on a 3-T Siemens scanner. Anatomical data was obtained using an isotropic T2-weighted 3-D SPACE sequence with multiplanar reformation capability. Dynamic data was obtained using 2-D FLASH cine sequences of the airway in three imaging planes during phonation. Audio recordings were captured by a MRI compatible optical microphone. All five cases had MRI and nasopharyngoscopy and four had videofluoroscopy performed. VPI was identified by MRI in all five patients. The location and severity of the velopharyngeal gap, closure pattern, velar size and shape and levator veli palatini (LVP) muscle were identified in all patients. MRI was superior in visualizing the integrity of the LVP muscle. MRI was unable to identify hemipalatal weakness in one case. In a case of stress-induced VPI, occurring only during clarinet playing, cine MRI demonstrated discordant findings of a velopharyngeal gap during phonatory tasks but not with instrument playing. Overall, there was satisfactory correlation among MRI, nasopharyngoscopy and videofluoroscopy findings. Cine MRI of the airway during speech is a noninvasive, well-tolerated diagnostic imaging tool that has the potential to serve as a guide prior to and after surgical correction of VPI. MRI provided superior anatomical detail of the levator

  1. Clinical and Histopathological Evaluation of Cutaneous Pythiosis in Donkeys (Equusasinus

    Directory of Open Access Journals (Sweden)

    José Alberto Cardona Álvarez

    2013-06-01

    Full Text Available The purpose of this study was to evaluate and characterize the clinical and histopathological aspects of cutaneous pythiosis in donkeys (Equus asinus in the Department of Cordoba, Colombia. A descriptive, non-probability study was conducted on domesticated animals. Nine donkeys clinically and histopathologically diagnosed with cutaneous pythiosis were analyzed. After describing the cases, a serious, crater-shaped granulomatous ulcer was observed, with necrotic tissue, a tumor appearance, abundant fibrinous-bloody exudation and yellowish-white caseous material known as kunkers. The lesions were found in the members, ventral abdomen and chest of the animals. Histopathologically, with the hematoxylin-eosin staining, severe pyogranulomatous dermatitis was observed, with abundant eosinophilic and neutrophilic inflammatory infiltrate; with the Grocott staining, hyphae with septa were found, partially branching into a right angle and brown in color. The definitive diagnosis of the disease was based on the clinical features, the differential diagnosis and the histopathological findings. The diagnosis of cutaneous pythiosis was conclusive. This study becomes the first report of this disease in donkeys (Equus asinus in the department of Córdoba and in Colombia.

  2. Real-time three-dimensional color doppler evaluation of the flow convergence zone for quantification of mitral regurgitation: Validation experimental animal study and initial clinical experience

    Science.gov (United States)

    Sitges, Marta; Jones, Michael; Shiota, Takahiro; Qin, Jian Xin; Tsujino, Hiroyuki; Bauer, Fabrice; Kim, Yong Jin; Agler, Deborah A.; Cardon, Lisa A.; Zetts, Arthur D.; hide

    2003-01-01

    BACKGROUND: Pitfalls of the flow convergence (FC) method, including 2-dimensional imaging of the 3-dimensional (3D) geometry of the FC surface, can lead to erroneous quantification of mitral regurgitation (MR). This limitation may be mitigated by the use of real-time 3D color Doppler echocardiography (CE). Our objective was to validate a real-time 3D navigation method for MR quantification. METHODS: In 12 sheep with surgically induced chronic MR, 37 different hemodynamic conditions were studied with real-time 3DCE. Using real-time 3D navigation, the radius of the largest hemispherical FC zone was located and measured. MR volume was quantified according to the FC method after observing the shape of FC in 3D space. Aortic and mitral electromagnetic flow probes and meters were balanced against each other to determine reference MR volume. As an initial clinical application study, 22 patients with chronic MR were also studied with this real-time 3DCE-FC method. Left ventricular (LV) outflow tract automated cardiac flow measurement (Toshiba Corp, Tokyo, Japan) and real-time 3D LV stroke volume were used to quantify the reference MR volume (MR volume = 3DLV stroke volume - automated cardiac flow measurement). RESULTS: In the sheep model, a good correlation and agreement was seen between MR volume by real-time 3DCE and electromagnetic (y = 0.77x + 1.48, r = 0.87, P time 3DCE-derived MR volume also showed a good correlation and agreement with the reference method (y = 0.89x - 0.38, r = 0.93, P time 3DCE can capture the entire FC image, permitting geometrical recognition of the FC zone geometry and reliable MR quantification.

  3. Comparative evaluation of the relative efficacy of the free mucosal graft and periosteal fenestration for increasing the vestibular depth - A clinical study

    Directory of Open Access Journals (Sweden)

    Nisha Yadav

    2014-01-01

    Full Text Available Purpose: The aim of the present study was to compare the periosteal fenestration (PF and free mucosal graft (FMG techniques in mandibular anterior region to increase the vestibular depth. Methodology: A total of 20 systemically healthy cases (10 patients in each group with shallow vestibular depth and reduced width of attached gingiva in lower anterior region were included in the present study. Clinical parameters recorded included Gingival index (GI, Plaque index (PI, Oral hygiene index simplified (OHI S, Vestibular depth (VD, width of attached gingiva and post operative discomfort. Findings: The results at the end of 3 months showed that the mean GI, PI, OHI S decreased significantly and remained low throughout the study period. The mean gain in percentage of vestibular depth at the end of 3 months for group 1(PF was 48.4% with relapse of 7.2% from the baseline. For group 2 (FMG, the mean gain in percentage of vestibular depth at the end of 3 months for was 50% with relapse of 6.2% from the baseline. The mean gain in percentage of attached gingiva at 3 months for group 1 and 2 was 65.9% and 74%, respectively. In comparison of group 1 and 2, group 2 showed better results in terms of increasing the vestibular depth and attached gingiva than group 1 although the intergroup comparison was not statistically significant. Conclusion: When aim of the clinician is to treat a patient with shallow vestibule together with reduced width of attached gingiva, the use of periosteal fenestration yields similar results to that of FMG.

  4. Nurse educators’ perceptions of OSCE as a clinical evaluation method

    Directory of Open Access Journals (Sweden)

    MM Chabeli

    2001-09-01

    Full Text Available The South African Qualifications Authority, and the South African Nursing Council are in pursuit of quality nursing education to enable the learners to practise as independent and autonomous practitioners. The educational programme should focus on the facilitation of critical and reflective thinking skills that will help the learner to make rational decisions and solve problems. A way of achieving this level of functioning is the use of assessment and evaluation methods that measure the learners’ clinical competence holistically. This article is focused on the perceptions of twenty nurse educators, purposively selected from three Nursing Colleges affiliated to a university in Gauteng, regarding the use of OSCE (Objective Structured Clinical Examination as a clinical evaluation method within a qualitative and descriptive research strategy. Three focus group interviews were conducted in different sessions. A descriptive content analysis was used. Trustworthiness was ensured by using Lincoln and Guba’s model (1985. The results revealed both positive and negative aspects of OSCE as a clinical evaluation method with regard to: administrative aspects; evaluators; learners; procedures/instruments and evaluation. The conclusion drawn from the related findings is that OSCE does not measure the learners’ clinical competence holistically. It is therefore recommended that the identified negative perception be taken as challenges faced by nurse educators and that the positive aspects be strengthened. One way of meeting these recommendations is the use of varied alternative methods for clinical assessment and evaluation that focus on the holistic measurement of the learners’ clinical competence.

  5. Clinical evaluation of SPECT in cerebrovascular disease

    International Nuclear Information System (INIS)

    Oshibuchi, Masao; Satoh, Mitsutaka; Kanda, Tetsuro; Nishi, Fumiaki; Yamane, Kanji; Fujimatsu, Masahiko; Edamitsu, Satoshi; Anno, Yasuro; Ohtake, Hisashi.

    1989-01-01

    In 131 patients with cerebrovascular disease, regional cerebral blood flow were determined by 123 I-IMP (N-isopropyl ( 123 I)-iodoamphetamine) or 99m Tc-HM-PAO ( 99m Tc (d, 1)-hexamethyl propyleneamine oxime) SPECT and findings were compared with those of X-CT or MRI. The perfusion deficit detected by SPECT was larger than the deficit by X-CT or MRI in every case. The perfusion deficit area was more clearly demonstrated by SPECT than by X-CT or MRI in patients with acute cerebral infarction. The hypoperfusion area determined by 123 I-IMP SPECT was wider than that by 99m Tc-HM-PAO SPECT. The crossed cerebellar diaschisis was observed in 56 out of 131 cases (43%). The results of operation were quantitatively evaluated by 123 I-IMP SPECT in 25 patients. (author)

  6. Electronic clinical safety reporting system: a benefits evaluation.

    Science.gov (United States)

    Elliott, Pamela; Martin, Desmond; Neville, Doreen

    2014-06-11

    Eastern Health, a large health care organization in Newfoundland and Labrador (NL), started a staged implementation of an electronic occurrence reporting system (used interchangeably with "clinical safety reporting system") in 2008, completing Phase One in 2009. The electronic clinical safety reporting system (CSRS) was designed to replace a paper-based system. The CSRS involves reporting on occurrences such as falls, safety/security issues, medication errors, treatment and procedural mishaps, medical equipment malfunctions, and close calls. The electronic system was purchased from a vendor in the United Kingdom that had implemented the system in the United Kingdom and other places, such as British Columbia. The main objective of the new system was to improve the reporting process with the goal of improving clinical safety. The project was funded jointly by Eastern Health and Canada Health Infoway. The objectives of the evaluation were to: (1) assess the CSRS on achieving its stated objectives (particularly, the benefits realized and lessons learned), and (2) identify contributions, if any, that can be made to the emerging field of electronic clinical safety reporting. The evaluation involved mixed methods, including extensive stakeholder participation, pre/post comparative study design, and triangulation of data where possible. The data were collected from several sources, such as project documentation, occurrence reporting records, stakeholder workshops, surveys, focus groups, and key informant interviews. The findings provided evidence that frontline staff and managers support the CSRS, identifying both benefits and areas for improvement. Many benefits were realized, such as increases in the number of occurrences reported, in occurrences reported within 48 hours, in occurrences reported by staff other than registered nurses, in close calls reported, and improved timelines for notification. There was also user satisfaction with the tool regarding ease of use

  7. CLINICAL STUDY OF CONCOMITANT SQUINT

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    Vijay Chopra

    2017-07-01

    Full Text Available BACKGROUND Malalignment in the visual axes of the two eyes is called strabismus. Fusion of both images is replaced either by diplopia or suppression of one image. Squint leads to loss of binocular single vision. Concomitant squint is a type of manifest squint in which the amount of deviation in the squinting eye is same in all gazes. Binocular single vision and ocular movement coordination are not present since birth, but are acquired in the early childhood. This process starts by the age of 3-6 months and is completed up to 5-6 years. Any hindrance in the development of these processes may result in concomitant squint. MATERIALS AND METHODS In 100 cases of concomitant squint, patients were included in our study. Detailed history was taken regarding the onset of squint and duration. Past history and family history was also elicited. General examination was done to detect any abnormalities of central nervous system. Routine ophthalmic examination including best corrected visual acuity, cover test performed to detect the type of deviation whether uniocular or alternating and the type of fixation. Angle of deviation was measured by Hirschberg’s test and on the synoptophore. Binocular single vision was assessed using Worth’s 4-dot test and synoptophore. Cycloplegic refraction and fundus evaluation done in all patients. Inclusion Criteria- All primary non-paralytic deviations, sensory deprivation strabismus. Exclusion Criteria- Paralytic strabismus, strabismus associated with neurological disorders, consecutive strabismus and palpebral fissure abnormalities patients. RESULTS Majority of cases of concomitant squint were of esotropic type. Most common form of esotropia seen was infantile esotropia. Most common form of exotropia was intermittent exotropia. 19% of cases were secondary to other ocular diseases namely cataract, macular lesion, high myopia, etc. Amblyopia was present in 54% patients and of very dense type, which could not be treated

  8. Evaluating online diagnostic decision support tools for the clinical setting.

    Science.gov (United States)

    Pryor, Marie; White, David; Potter, Bronwyn; Traill, Roger

    2012-01-01

    Clinical decision support tools available at the point of care are an effective adjunct to support clinicians to make clinical decisions and improve patient outcomes. We developed a methodology and applied it to evaluate commercially available online clinical diagnostic decision support (DDS) tools for use at the point of care. We identified 11 commercially available DDS tools and assessed these against an evaluation instrument that included 6 categories; general information, content, quality control, search, clinical results and other features. We developed diagnostically challenging clinical case scenarios based on real patient experience that were commonly missed by junior medical staff. The evaluation was divided into 2 phases; an initial evaluation of all identified and accessible DDS tools conducted by the Clinical Information Access Portal (CIAP) team and a second phase that further assessed the top 3 tools identified in the initial evaluation phase. An evaluation panel consisting of senior and junior medical clinicians from NSW Health conducted the second phase. Of the eleven tools that were assessed against the evaluation instrument only 4 tools completely met the DDS definition that was adopted for this evaluation and were able to produce a differential diagnosis. From the initial phase of the evaluation 4 DDS tools scored 70% or more (maximum score 96%) for the content category, 8 tools scored 65% or more (maximum 100%) for the quality control category, 5 tools scored 65% or more (maximum 94%) for the search category, and 4 tools score 70% or more (maximum 81%) for the clinical results category. The second phase of the evaluation was focused on assessing diagnostic accuracy for the top 3 tools identified in the initial phase. Best Practice ranked highest overall against the 6 clinical case scenarios used. Overall the differentiating factor between the top 3 DDS tools was determined by diagnostic accuracy ranking, ease of use and the confidence and

  9. Evaluation of Stream Mining Classifiers for Real-Time Clinical Decision Support System: A Case Study of Blood Glucose Prediction in Diabetes Therapy

    Directory of Open Access Journals (Sweden)

    Simon Fong

    2013-01-01

    Full Text Available Earlier on, a conceptual design on the real-time clinical decision support system (rt-CDSS with data stream mining was proposed and published. The new system is introduced that can analyze medical data streams and can make real-time prediction. This system is based on a stream mining algorithm called VFDT. The VFDT is extended with the capability of using pointers to allow the decision tree to remember the mapping relationship between leaf nodes and the history records. In this paper, which is a sequel to the rt-CDSS design, several popular machine learning algorithms are investigated for their suitability to be a candidate in the implementation of classifier at the rt-CDSS. A classifier essentially needs to accurately map the events inputted to the system into one of the several predefined classes of assessments, such that the rt-CDSS can follow up with the prescribed remedies being recommended to the clinicians. For a real-time system like rt-CDSS, the major technological challenges lie in the capability of the classifier to process, analyze and classify the dynamic input data, quickly and upmost reliably. An experimental comparison is conducted. This paper contributes to the insight of choosing and embedding a stream mining classifier into rt-CDSS with a case study of diabetes therapy.

  10. Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study.

    Science.gov (United States)

    Wirz, Stefan; Conrad, Stefan; Shtrichman, Ronit; Schimo, Kai; Hoffmann, Eva

    2017-01-01

    Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute. A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group ( n = 43), opioids dispensed by nurses, and a test group ( n = 27), opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed. No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group ( P value PCoA Acute users were satisfied with its use. The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

  11. Clinical Evaluation of a Novel Technology for Oral Patient-Controlled Analgesia, the PCoA® Acute Device, for Hospitalized Patients with Postoperative Pain, in Pilot Feasibility Study

    Directory of Open Access Journals (Sweden)

    Stefan Wirz

    2017-01-01

    Full Text Available Background. Acute postoperative pain delays recovery and increases morbidity and mortality. Traditional administration of postoperative analgesics by nurses is often inefficient. The present study evaluated the safety, efficacy, and usability of a novel, patient-controlled analgesic dispenser, the PCoA Acute. Methods. A controlled pilot study was conducted at three medical centers. Patients scheduled for elective surgery were enrolled into two groups, both taking oral analgesics: a control group (n=43, opioids dispensed by nurses, and a test group (n=27, opioids dispensed via the PCoA Acute. Pill intake data were recorded. Pain ratings at rest and during movement were surveyed. Results. No severe adverse events were recorded. Average pill intake time was reduced from 8 : 58 minutes in the control group to 1 : 17 minutes in the test group (P value < 0.05. The test group took 67% more pills than the control group, indicating enhanced compliance. Pain scores were significantly lower for patients in the test group (P value < 0.05. Over 90% of PCoA Acute users were satisfied with its use. Conclusions. The study confirmed that PCoA Acute is safe and effective. It is well accepted by patients and medical staff. Its use can optimize pain medication administration.

  12. Randomised clinical trial: evaluation of the efficacy of mesalazine (mesalamine) suppositories in patients with ulcerative colitis and active rectal inflammation -- a placebo-controlled study.

    Science.gov (United States)

    Watanabe, M; Nishino, H; Sameshima, Y; Ota, A; Nakamura, S; Hibi, T

    2013-08-01

    Mesalazine suppositories are recommended and widely used as the standard therapy in induction and maintenance of remission for proctitis. To evaluate the efficacy of mesalazine suppositories in patients with ulcerative colitis (UC) and rectal inflammation; and in patient groups categorised by the extent of lesions. This study was a phase III multicentre, randomised, double-blind, placebo-controlled, parallel-group study. Mild-to-moderate UC patients with rectal inflammation were randomly assigned either a 1 g mesalazine or placebo suppository. The suppository was administered in the rectum once daily for 4 weeks. The primary efficacy end point was the rate of endoscopic remission (mucosal score of 0 or 1) after 4 weeks. The endoscopic remission rates after 4 weeks in the mesalazine and placebo suppository groups were 81.5% and 29.7%, respectively, and the superiority of mesalazine to placebo was confirmed (P suppositories in all types of UC patients with rectal inflammation was confirmed for the first time in a double-blind, placebo-controlled, parallel-group study (JapicCTI- 111421). © 2013 John Wiley & Sons Ltd.

  13. Evaluation of clinical methods for peroneal muscle testing.

    Science.gov (United States)

    Sarig-Bahat, Hilla; Krasovsky, Andrei; Sprecher, Elliot

    2013-03-01

    Manual muscle testing of the peroneal muscles is well accepted as a testing method in musculoskeletal physiotherapy for the assessment of the foot and ankle. The peroneus longus and brevis are primary evertors and secondary plantar flexors of the ankle joint. However, some international textbooks describe them as dorsi flexors, when instructing peroneal muscle testing. The identified variability raised a question whether these educational texts are reflected in the clinical field. The purposes of this study were to investigate what are the methods commonly used in the clinical field for peroneal muscle testing and to evaluate their compatibility with functional anatomy. A cross-sectional study was conducted, using an electronic questionnaire sent to 143 Israeli physiotherapists in the musculoskeletal field. The survey questioned on the anatomical location of manual resistance and the combination of motions resisted. Ninety-seven responses were received. The majority (69%) of respondents related correctly to the peronei as evertors, but asserted that resistance should be located over the dorsal aspect of the fifth metatarsus, thereby disregarding the peroneus longus. Moreover, 38% of the respondents described the peronei as dorsi flexors, rather than plantar flexors. Only 2% selected the correct method of resisting plantarflexion and eversion at the base of the first metatarsus. We consider this technique to be the most compatible with the anatomy of the peroneus longus and brevis. The Fisher-Freeman-Halton test indicated that there was a significant relationship between responses on the questions (P = 0.0253, 95% CI 0.0249-0.0257), thus justifying further correspondence analysis. The correspondence analysis found no clustering of the answers that were compatible with anatomical evidence and were applied in the correct technique, but did demonstrate a common error, resisting dorsiflexion rather than plantarflexion, which was in agreement with the described

  14. Clinical studies on Bell's palsy

    International Nuclear Information System (INIS)

    Yamada, Yoshio

    1985-01-01

    The purpose of this study was to evaluate the diagnostic value of the salivary gland scintigraphy using sup(99m)Tc-pertechnetate for the prognosis of Bell's palsy. The salivary gland scintigraphy was performed in 40 patients with Bell's palsy and 15 normal subjects. After intravenous injection of 10 mCt of sup(99m)Tc-pertechnetate, sequential scintigrams were taken with a scintillation camera every one minute for 25 minutes. At 15 minutes after injection, both of normal subjects and patients were given ascorbic acid to stimulate the secretion of saliva. By the present method, the time activity curve was examined for the regions of interest over the parotid and submandibular glands and backgrounds. In normal subjects, values of the concentration and excretory ratio between the right and left sides of the parotid and submandibular glands were more than 80%. Some patients with Bell's palsy showed a decreased concentration and/or excretory ratio less than 80% between the normal and affected sides of the parotid glands. This suggests a functional involvement of the facial nerve in the salivary secretion from the parotid glands. On examination within 10 days of the onset of Bell's palsy, 31 cases with complete recovery showed values of the concentration ratio and/or excretory ratio more than 80% between the normal and affected sides of the submandibular glands. In contrast, 9 cases with imcomplete recovery showed low values of the concentration ratio and excretory ratio less than 80%. In the latter, more active treatments such as decompression operation should be considerd in the early stage of the palsy. The salivary scintigraphy using sup(99m)Tc-pertechnetate is more valuable as an early prognostic indicator for Bell's palsy compared with other prognostic tests such as the lid vibration test, the stapedial reflex test, the electrogustometry, the nerve excitability test and the evoked electromyography. (author)

  15. Clinical Evaluation of Inpatients with Acute Urticaria

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    Ayşe Serap

    2011-12-01

    Full Text Available Background and Design: To determine the clinical and etiological features of inpatients with acute urticaria and angioedema and to assess the need for laboratory tests. Material and Methods: We recruited 105 patients with acute urticaria and angioedema who were admitted to our inpatient unit. The lesions and the characteristics of the patients were analyzed. Routine diagnostic tests including complete blood count, thyroid function tests, hepatitis panel, stool parasite, total IgE levels, cultures, erythrocyte sedimentation rate, C-reactive protein, anti-nuclear antibody, and posterior anterior lung X-ray were ordered. A psychiatric consultation was obtained, when needed. The results were analyzed with SPSS 15.0 statistical software.Results: Among 105 patients, 28 (26.7% had urticaria, 7 (6.7% had angioedema, and 70 (66.7% suffered from both urticaria and angioedema. The most common accompanying symptoms were itching (91.4% and burning (34.3%. The most common systemic symptoms were fatigue (15.2% and headache (12.4%. The lesions usually appeared in the evening hours (24.8%. Twenty-five patients were waking up due to itching during the night. Some lesions were associated with physical activities. Systemic diseases accompanied the lesions in 12 patients (11%. In terms of etiological factors, 33 patients (22.5% had infections. Food- related lesions were encountered in 14 (13% patients. Thirty patients (28.5% had history of medication use. Stress was detected in 37.1% of the patients; anxiety was diagnosed in 3% of patients. The stool was positive for parasites in 10 (9% patients. Conclusion: Acute urticaria is a benign disorder. Although the underlying cause of urticaria can not always be identified, infections and medications are the most common causes. A comprehensive and detailed history is very important to discover the underlying cause. The diagnostic tests should be ordered according to the patient’s history. Conducting diagnostic tests

  16. Bacteriological And Clinical Evaluation Of Twelve Cases Of Post ...

    African Journals Online (AJOL)

    Bacteriological And Clinical Evaluation Of Twelve Cases Of Post-Surgical Sepsis Of Odontogenic Tumours At A ... East African Medical Journal ... Intervention: Adequate review of patient\\'s medical history, bacteriological investigations and

  17. Some products from CLRI under clinical use and evaluation

    Indian Academy of Sciences (India)

    First page Back Continue Last page Overview Graphics. Some products from CLRI under clinical use and evaluation. As burn dressing materials. As wound healing support system. In dentistry: in treatment of gingivial recession. In ophthalmology: as lens support system.

  18. Clinical utility of breath ammonia for evaluation of ammonia physiology in healthy and cirrhotic adults

    OpenAIRE

    Spacek, Lisa A; Mudalel, Matthew; Tittel, Frank; Risby, Terence H; Solga, Steven F

    2015-01-01

    Blood ammonia is routinely used in clinical settings to assess systemic ammonia in hepatic encephalopathy and urea cycle disorders. Despite its drawbacks, blood measurement is often used as a comparator in breath studies because it is a standard clinical test. We sought to evaluate sources of measurement error and potential clinical utility of breath ammonia compared to blood ammonia.

  19. A Clinical Evaluation Of Cone Beam Computed Tomography

    Science.gov (United States)

    2016-06-01

    A CLINICAL EVALUATION OF CONE BEAM COMPUTED TOMOGRAPHY by Bryan James Behm, D.D.S. Lieutenant, Dental Corps United States Navy A thesis... COMPUTED TOMOGRAPHY " is appropriately acknowledged and, beyond brief excerpts, is with the permission of the copyright owner. ~mes Behm Endodontic...printed without the expressed written permission of the author. IV ABSTRACT A CLINICAL EVALUATION OF CONE BEAM COMPUTED TOMOGRAPHY BRYAN JAMES

  20. A new universal simplified adhesive: 6-month clinical evaluation.

    Science.gov (United States)

    Mena-Serrano, Alexandra; Kose, Carlos; De Paula, Eloisa Andrade; Tay, Lidia Yileng; Reis, Alessandra; Loguercio, Alessandro D; Perdigão, Jorge

    2013-02-01

    Multimode adhesives, which can be used as etch-and-rinse or as self-etch adhesives, have been recently introduced without clinical data to back their use. To evaluate the 6-month clinical performance of Scotchbond Universal Adhesive (SU; 3M ESPE, St. Paul, MN, USA) in noncarious cervical lesions (NCCLs) using two evaluation criteria. Thirty-nine patients participated in this study. Two hundred restorations were assigned to four groups: SU-TEm: etch-and-rinse + moist dentin; SU-TEd: etch-and-rinse + dry dentin; SU-SEet: selective enamel etching; and SU-SE: self-etch. The composite resin Filtek Supreme Ultra (3M ESPE) was placed incrementally. The restorations were evaluated at baseline and after 6 months using both the World Dental Federation (FDI) and the United States Public Health Service (USPHS) criteria. Statistical analyses were performed with Friedman repeated measures analysis of variance by rank and McNemar test for significance in each pair (α = 0.05). Only four restorations (SU-SE: 3 and SU-TEm: 1) were lost after 6 months (p > 0.05 for either criteria). Marginal discoloration occurred in one restoration in the SU-SE group (p > 0.05 for either criteria). Only 2/200 restorations were scored as bravo for marginal adaptation using the USPHS criteria (one for SU-SE and one for SU-SEet, p > 0.05). However, when using the FDI criteria, the percentage of bravo scores for marginal adaptation at 6 months were 32%, 36%, 42%, and 46% for groups SU-TEm, SU-TEd, SU-SEet, and SU-SE, respectively (p > 0.05). The clinical behavior of the multimode adhesive does not depend on the bonding strategy at 6 months. The FDI evaluation criteria are more sensitive than the USPHS criteria. At 6 months, the clinical behavior of the new multimode adhesive Scotchbond Universal was found to be reliable when used in noncarious cervical lesions and may not depend on the bonding strategy employed. © 2012 Wiley Periodicals, Inc.

  1. Assessment of [18F]-fluoroacetate PET/CT as a tumor-imaging modality. Preclinical study in healthy volunteers and clinical evaluation in patients with liver tumor

    International Nuclear Information System (INIS)

    Takemoto, Kenji; Hatano, Etsuro; Nishii, Ryuichi

    2014-01-01

    Although [ 18 F]-FDG is a useful oncologic PET tracer, FDG uptake is known to be low in a certain type of hepatocellular carcinoma (HCC). [ 18 F]-fluoroacetate ( 18 F-FACE) is an [ 18 F] fluorinated acetate, which is known to be converted into fatty acids, incorporated in membrane and is expected to be a promising oncologic PET tracer. The aim of this study was to evaluate the usefulness of 18 F-FACE as an oncologic PET tracer in preclinical study in healthy volunteers and in patients with liver tumors. Twenty-four healthy volunteers (age 48.2 ± 12.9 years old; 15 male and 9 female) and ten patients with liver tumor (age 72.1 ± 7.0 years old; 6 male and 4 female) were included. We performed whole-body static PET/CT scan using 18 F-FACE (n=34) and 18 F-FDG (n=5 for volunteers, n=8 for patients) on each day, respectively. Qualitative analysis and quantitative analysis of tumors (5 HCCs, 1 cholangiocellular carcinoma, 4 metastatic tumors from colon cancer and P-NET) were performed using SUVmax and tumor-to-normal liver ratio (TNR). In healthy volunteers, 18 F-FACE was metabolically stable in vivo and its biodistribution was almost similar to blood pool, basically uniformly independent of age and gender during PET scan time (up to 3 h). Normal physiological uptake of 18 F-FACE at each organ including liver (SUVmean 1.8 ± 0.2) was lower than that of blood pool (SUVmean 2.3 ± 0.3) at 1 h after injection. Chronic inflammatory uptake around femur of post-operative state of femoral osteotomy and faint uptake of benign hemangioma were observed in a case of healthy volunteer. 18 F-FACE (SUVmax 2.7 ± 0.6, TNR 1.5 ± 0.4) of liver tumors was significantly lower than those of 18 F-FDG uptake (6.5 ± 4.2, 2.6 ± 1.7, respectively). In qualitative analysis, 18 F-FDG was positive in 4 tumors (3 HCCs, 1 CCC) and negative in the other 6 tumors, while 18 F-FACE was also positive in 4 tumors which were the same tumors with positive 18 F-FDG uptake. Biodistribution of 18 F-FACE was

  2. Clinical evaluation of post-extraction site wound healing.

    Science.gov (United States)

    Adeyemo, Wasiu Lanre; Ladeinde, Akinola Ladipo; Ogunlewe, Mobolanle Olugbemiga

    2006-07-01

    The aim of this prospective study was to evaluate the clinical pattern of post-extraction wound healing with a view to identify the types, incidence, and pattern of healing complications following non-surgical tooth extraction. A total of 311 patients, who were referred for non-surgical (intra-alveolar) extractions, were included in the study. The relevant pre-operative information recorded for each patient included age and gender of the patient, indications for extraction, and tooth/teeth removed. Extractions were performed under local anesthesia with dental forceps, elevators, or both. Patients were evaluated on the third and seventh postoperative days for alveolus healing assessment. Data recorded were: biodata, day of presentation for alveolus healing assessment, day of onset of any symptoms, body temperature (degrees C) in cases of alveolus infection, and presence or absence of pain. Two hundred eighty-two patients (282) with 318 extraction sites were evaluated for alveolus healing. Healing was uneventful in 283 alveoli (89%), while 35 alveoli (11%) developed healing complications. These complications were: localized osteitis 26 (8.2%); acutely infected alveolus 5 (1.6%); and an acutely inflamed alveolus 4 (1.2%). Females developed more complications than males (p=0.003). Most complications were found in molars (60%) and premolars (37.1%). Localized osteitis caused severe pain in all cases, while infected and inflamed alveolus caused mild or no pain. Thirty patients (12%) among those without healing complications experienced mild pain. Most of the post-extraction alveoli healed uneventfully. Apart from alveolar osteitis (AO), post-extraction alveolus healing was also complicated by acutely infected alveoli and acutely inflamed alveoli. This study also demonstrated a painful alveolus is not necessarily a disturbance of post-extraction site wound healing; a thorough clinical examination must, therefore, be made to exclude any of the complications.

  3. Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.

    Science.gov (United States)

    Hequet, Delphine; Callens, Céline; Gentien, David; Albaud, Benoit; Mouret-Reynier, Marie-Ange; Dubot, Coraline; Cottu, Paul; Huchon, Cyrille; Zilberman, Sonia; Berseneff, Helene; Foa, Cyril; Salmon, Rémy; Roulot, Aurélie; Lerebours, Florence; Salomon, Anne; Ghali, Nadeem; Morel, Pascale; Li, Qianyi; Cayre, Anne; Guinebretière, Jean-Marc; Hornberger, John; Penault-Llorca, Frédérique; Rouzier, Roman

    2017-01-01

    The Prosigna® breast cancer prognostic gene signature assay identifies a gene-expression profile that permits the classification of tumors into subtypes and gives a score for the risk of recurrence (ROR) at 10 years. The primary objective of this multicenter study was to evaluate the impact of Prosigna's assay information on physicians' adjuvant treatment decisions in patients with early-stage breast cancer. Secondary objectives were to assess confidence of practitioners in their therapeutic recommendations before and after the added information provided by the Prosigna assay; and to evaluate the emotional state of patients before and after the Prosigna test results. Consecutive patients with invasive early-stage breast cancer were enrolled in a prospective, observational, multicenter study carried out in 8 hospitals in France. The Prosigna test was carried out on surgical specimens using the nCounter® Analysis System located at the Institut Curie. Both before and after receiving the Prosigna test results, physicians completed treatment confidence questionnaires and patients completed questionnaires concerning their state of anxiety, the difficulties felt in face of the therapy and quality of life. Information was also collected at 6 months regarding the physicians' opinion on the test results and the patients' degree of anxiety, difficulties with therapy and quality of life. Between March 2015 and January 2016, 8 study centers in France consecutively enrolled 210 postmenopausal women with estrogen receptor (ER) positive, human epidermal growth hormone-2 (HER-2) negative, and node negative tumors, either stage 1 or stage 2. Intrinsic tumor subtypes as assessed by the Prosigna test were 114 (58.2%) Luminal A, 79 (40.3%) Luminal B, 1 (0.5%) HER-2 enriched (HER-2E), and 2 (1.0%) basal-like. Before receiving the Prosigna test results, physicians categorized tumor subtypes based on immunohistochemistry (IHC) as Luminal A in 126 (64%) patients and Luminal B in 70 (36

  4. Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.

    Directory of Open Access Journals (Sweden)

    Delphine Hequet

    Full Text Available The Prosigna® breast cancer prognostic gene signature assay identifies a gene-expression profile that permits the classification of tumors into subtypes and gives a score for the risk of recurrence (ROR at 10 years. The primary objective of this multicenter study was to evaluate the impact of Prosigna's assay information on physicians' adjuvant treatment decisions in patients with early-stage breast cancer. Secondary objectives were to assess confidence of practitioners in their therapeutic recommendations before and after the added information provided by the Prosigna assay; and to evaluate the emotional state of patients before and after the Prosigna test results.Consecutive patients with invasive early-stage breast cancer were enrolled in a prospective, observational, multicenter study carried out in 8 hospitals in France. The Prosigna test was carried out on surgical specimens using the nCounter® Analysis System located at the Institut Curie. Both before and after receiving the Prosigna test results, physicians completed treatment confidence questionnaires and patients completed questionnaires concerning their state of anxiety, the difficulties felt in face of the therapy and quality of life. Information was also collected at 6 months regarding the physicians' opinion on the test results and the patients' degree of anxiety, difficulties with therapy and quality of life.Between March 2015 and January 2016, 8 study centers in France consecutively enrolled 210 postmenopausal women with estrogen receptor (ER positive, human epidermal growth hormone-2 (HER-2 negative, and node negative tumors, either stage 1 or stage 2. Intrinsic tumor subtypes as assessed by the Prosigna test were 114 (58.2% Luminal A, 79 (40.3% Luminal B, 1 (0.5% HER-2 enriched (HER-2E, and 2 (1.0% basal-like. Before receiving the Prosigna test results, physicians categorized tumor subtypes based on immunohistochemistry (IHC as Luminal A in 126 (64% patients and Luminal B in

  5. A new universal simplified adhesive: 18-month clinical evaluation.

    Science.gov (United States)

    Perdigão, J; Kose, C; Mena-Serrano, A P; De Paula, E A; Tay, L Y; Reis, A; Loguercio, A D

    2014-01-01

    To evaluate the 18-month clinical performance of a multimode adhesive (Scotchbond Universal Adhesive, SU, 3M ESPE, St Paul, MN, USA) in noncarious cervical lesions (NCCLs) using two evaluation criteria. Thirty-nine patients participated in this study. Two-hundred restorations were assigned to four groups: ERm, etch-and-rinse + moist dentin; ERd, etch-and-rinse + dry dentin; Set, selective enamel etching; and SE, self-etch. The composite resin, Filtek Supreme Ultra (3M ESPE), was placed incrementally. The restorations were evaluated at baseline, and at 18 months, using both the World Dental Federation (FDI) and the United States Public Health Service (USPHS) criteria. Statistical analyses were performed using Friedman repeated-measures analysis of variance by rank and McNemar test for significance in each pair (α=0.05). Five restorations (SE: 3; Set: 1; and ERm: 1) were lost after 18 months (p>0.05 for either criteria). Marginal staining occurred in four and 10% of the restorations evaluated (p>0.05), respectively, for USPHS and FDI criteria. Nine restorations were scored as bravo for marginal adaptation using the USPHS criteria and 38%, 40%, 36%, and 44% for groups ERm, ERd, Set, and SE, respectively, when the FDI criteria were applied (p>0.05). However, when semiquantitative scores (or SQUACE) for marginal adaptation were used, SE resulted in a significantly greater number of restorations, with more than 30% of the total length of the interface showing marginal discrepancy (28%) in comparison with the other groups (8%, 6%, and 8%, respectively, for ERm, ERd, and Set). The clinical retention of the multimode adhesive at 18 months does not depend on the bonding strategy. The only differences between strategies were found for the parameter marginal adaptation, for which the FDI criteria were more sensitive than the USPHS criteria.

  6. Clinical evaluation of JPEG2000 compression for digital mammography

    Science.gov (United States)

    Sung, Min-Mo; Kim, Hee-Joung; Kim, Eun-Kyung; Kwak, Jin-Young; Yoo, Jae-Kyung; Yoo, Hyung-Sik

    2002-06-01

    Medical images, such as computed radiography (CR), and digital mammographic images will require large storage facilities and long transmission times for picture archiving and communications system (PACS) implementation. American College of Radiology and National Equipment Manufacturers Association (ACR/NEMA) group is planning to adopt a JPEG2000 compression algorithm in digital imaging and communications in medicine (DICOM) standard to better utilize medical images. The purpose of the study was to evaluate the compression ratios of JPEG2000 for digital mammographic images using peak signal-to-noise ratio (PSNR), receiver operating characteristic (ROC) analysis, and the t-test. The traditional statistical quality measures such as PSNR, which is a commonly used measure for the evaluation of reconstructed images, measures how the reconstructed image differs from the original by making pixel-by-pixel comparisons. The ability to accurately discriminate diseased cases from normal cases is evaluated using ROC curve analysis. ROC curves can be used to compare the diagnostic performance of two or more reconstructed images. The t test can be also used to evaluate the subjective image quality of reconstructed images. The results of the t test suggested that the possible compression ratios using JPEG2000 for digital mammographic images may be as much as 15:1 without visual loss or with preserving significant medical information at a confidence level of 99%, although both PSNR and ROC analyses suggest as much as 80:1 compression ratio can be achieved without affecting clinical diagnostic performance.

  7. Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: a prospective, randomized, multicenter study.

    Science.gov (United States)

    Kamiya, K; Nakanishi, M; Ishii, R; Kobashi, H; Igarashi, A; Sato, N; Shimizu, K

    2012-10-01

    To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome. This study evaluated 64 eyes of 32 patients (age: 62.6±12.8 years (mean±SD)) in whom treatment with 0.1% sodium hyaluronate was insufficiently responsive. The eyes were randomly assigned to one of the two regimens in each patient: topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye, and that of sodium hyaluronate in the other. Before treatment, and 2 and 4 weeks after treatment, we determined tear volume, tear film break-up time (BUT), fluorescein and rose bengal vital staining scores, subjective symptoms, and adverse events. We found a significant improvement in BUT (P=0.049, Dunnett test), fluorescein and rose bengal staining scores (P=0.02), and in subjective symptoms (P=0.004 for dry eye sensation, P=0.02 for pain, and P=0.02 for foreign body sensation) 4 weeks after treatment in the diquafosol eyes. On the other hand, we found no significant change in these parameters after treatment in the control eyes. In dry eyes, where sodium hyaluronate monotherapy was insufficient, diquafosol tetrasodium was effective in improving objective and subjective symptoms, suggesting its viability as an option for the additive treatment of such eyes.

  8. Evaluation of gastric emptying function in clinical practice.

    Science.gov (United States)

    Poitras, P; Picard, M; Déry, R; Giguère, A; Picard, D; Morais, J; Plourde, V; Boivin, M

    1997-11-01

    In this retrospective analysis, we compared different methods to evaluate gastric emptying function, aiming to improve the sensitivity and the clinical availability of our diagnostic testing. In the first study, we compared, in 72 patients clinically suspected of gastroparesis, the emptying of a meal containing two solid nutrients with different disintegration rates: 111In-labeled scrambled eggs and 99Tc-labeled liver cubes. Gastric emptying of 111In-labeled egg was delayed in 12 of our patients and the evacuation of the 99Tc-labeled liver was prolonged in 19 patients. The choice of the nutrient was not important for the identification of diabetic gastroparesis (43% vs 57%; NS), but it was determinant in the case of patients suspected of idiopathic gastroparesis (12% were positive with the egg and 25% with the liver; P egg as a radiolabeled tracer in order to improve the sensitivity of the test for detection of gastroparesis; and (2) the radiological detection of radiopaque markers is a reliable and convenient method for the detection of gastroparesis in clinical practice. It is possibly more sensitive than scintigraphy.

  9. IT-benchmarking of clinical workflows: concept, implementation, and evaluation.

    Science.gov (United States)

    Thye, Johannes; Straede, Matthias-Christopher; Liebe, Jan-David; Hübner, Ursula

    2014-01-01

    Due to the emerging evidence of health IT as opportunity and risk for clinical workflows, health IT must undergo a continuous measurement of its efficacy and efficiency. IT-benchmarks are a proven means for providing this information. The aim of this study was to enhance the methodology of an existing benchmarking procedure by including, in particular, new indicators of clinical workflows and by proposing new types of visualisation. Drawing on the concept of information logistics, we propose four workflow descriptors that were applied to four clinical processes. General and specific indicators were derived from these descriptors and processes. 199 chief information officers (CIOs) took part in the benchmarking. These hospitals were assigned to reference groups of a similar size and ownership from a total of 259 hospitals. Stepwise and comprehensive feedback was given to the CIOs. Most participants who evaluated the benchmark rated the procedure as very good, good, or rather good (98.4%). Benchmark information was used by CIOs for getting a general overview, advancing IT, preparing negotiations with board members, and arguing for a new IT project.

  10. Common carotid artery thrombosis; Clinical and radiological evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Ito, Yasuhiro; Yasuda, Takeshi; Hakusui, Shigetaka; Yanagi, Tsutomu (Nagoya Daini Red Cross Hospital (Japan)); Ito, Eiichi

    1994-02-01

    Common carotid artery thrombosis (CCAT) is not common. We studied 4 patients with CCAT to clarify the clinical and radiological features of this disorder. Case 1 had only episodes of TIA. Case 2 was diagnosed by chance as having CCAT at the time of admission due to cerebellar infarction. On the contrary, Cases 3 and 4 were admitted because of disturbance of consciousness and hemiparesis. Case 4 died soon after his stroke because of complications. We evaluated cases 1, 2 and 3 using head CT, head MRI, neck MRI, MR angiography, SPECT and cerebral angiography. Case 4, who was evaluated with head CT and cerebral angiography, was autopsied to confirm the occlusion of the common carotid artery. The clinical severity of CCAT varies from asymptomatic to severe, because each case differs in the time taken for complete occlusion of the common carotid artery; the development of collateral circulation; and hemodynamics of the brain. As for the collaterals their contribution is variable; for example, the thyrocervical and other arteries function as the bypass. We can diagnose CCAT easily and noninvasively using MR angiography and neck MRI based on disappearance of the flow void in the common carotid artery or internal carotid artery. On physical examination, it is important to detect faded pulsation of the superficial temporal artery that is ipsilateral to the occluded common carotid artery. (author).

  11. Evaluation of cardiology consultations sought from the anaesthesia clinic

    International Nuclear Information System (INIS)

    Minai, F.N.; Kamal, R.S.

    2004-01-01

    Objective: To evaluate the criteria for cardiology referrals and to assess the perioperative relevance of the cardiology advice given in patients evaluated for non-cardiac surgery. Materials and Methods: A review of case files of 70 patients, scheduled for non-cardiac surgery, who were referred for cardiology consultations from the Anaesthesia Clinic at AKUH during the study period. The clinical criteria for seeking cardiology advice, the cardiology advice given, its influence on patient management, as well as number of adverse cardiac events in the perioperative period were documented. Results: A history of hypertension, ischemic heart disease, and ECG abnormalities were the major criteria for seeking opinion on cardiac status. Cardiology advice frequently resulted in the ordering of extensive cardiac investigations. Among the patients identified for further tests by the cardiologists, 75% had no evidence of ischemic heart disease or myocardial dysfunction; none of them were monitored invasively intraoperatively or had adverse cardiac events in the perioperative period requiring intensive care or prolonged hospital stay. Conclusion: No definite criteria or pattern for referrals was identified. Most of the referrals did not fall within the AHA guidelines. Cardiology advice given had very little influence on the perioperative management. (author)

  12. Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

    Science.gov (United States)

    Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

    2017-01-01

    For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

  13. Radiological evaluation of swallowing and clinical patterns of systemic sclerosis

    International Nuclear Information System (INIS)

    Montesi, A.; Pesaresi, A.; Cavalli, M.L.; Serri, L.; Salmistraro, D.; Candela, M.; Gabrielli, A.

    1990-01-01

    Fifty-one patients with systemic sclerosis (scleroderma) were studied by means of videofluoroscopy in order to evaluate the abnormalities in the oral-pharyngeal and esophageal phases of deglutition and to correlate the radiological patterns with the clinical features of the disease. Thirteen patients (25.5%) exhibited swallowing disorders such as oral leakage, retention, penetration, mild or moderate aspiration and abnormal upper esophageal sphincter behavior. These dysfunctions were more evident in patients with esophageal motility abnormalities. A normal radiological pattern in the esophagus was not associated with swallowing alterations. Remarkably, patients with oral-pharyngeal disorders had a higher incidence of lung diseases. Forty-five patients (88%) exhibited disorders of the esophageal phase of deglutition, such as mild or severe motility abnormalities or hiatal hernia, gastro-esophageal reflux, reflux esophagitis, and stricture. Radiological findings in the esophagus can be abnormal in the early stages of the disease. On the other hand, the radiological pattern of esophageal motility can be occasionally negative in advanced or extensive disease. This indicates a discrepancy between clinical symptoms and radiological picture of the esophagus. The radiological examination of the oral-pharyngeal and esophageal phases of deglutition is important in patients with scleroderma in order to evaluate visceral involvement, motility disorders, and risk of aspiration. Such radiological information can be useful in preventing esophagitis and pulmonary complications

  14. Clinical diagnostic potentials of thyroid ultrasonography and scintigraphy; An evaluation

    Energy Technology Data Exchange (ETDEWEB)

    Torizuka, Tatsuo; Kasagi, Kanji; Hatabu, Hiroto; Misaki, Takashi; Iida, Yasuhiro; Konishi, Junji (Kyoto Univ. (Japan). Hospital); Endo, Keigo

    1993-06-01

    This prospective study was designed to evaluate the potential contributions of high resolution ultrasonography (US) and Tc-99m scintigraphy in the routine diagnosis of thyroid disease. The diagnostic impacts of US and Tc-99m scintigraphy results in 177 patients visiting our thyroid clinic were assessed and scored according to the following criteria: when the information provided by either test supported, confirmed or changed the initial clinical diagnosis, they received scores of 2, 3 and 4 respectively, while score 1 was given when the test itself was useless for the differential diagnosis. US identified focal lesions that both palpation and scintigraphy had failed to detect in 14 (12.1%) of 116 patients with diffuse thyroid diseases, suggesting the necessity of Hashimoto's thyroiditis, adenoma, adenocarcinoma and adenomatous goiter, and vice versa in the diagnosis of hyperthyroid and euthyroid Graves's diseases. Thus, the advantages of US over scintigraphy for morphological evaluation were confirmed. US was particularly useful for the differential diagnosis of adenomatous goiter from Hashimoto's thyroiditis or a single nodular disease. In contrast, scintigraphy gave functional images, being especially helpful for the differential diagnosis of thyrotoxicosis. (author).

  15. Organizational evaluation of an interprofessional study unit

    DEFF Research Database (Denmark)

    Jensen, Didde Cramer; Nørgaard, Birgitte; Draborg, Eva

    2012-01-01

    This article presents results from an organizational evaluation of an interprofessional clinical study unit (ICS) in Denmark. The aim of this study was to test whether the ICS was based on a durable organizational concept and to identify the prerequisites for the unit to be successful...

  16. Evaluation of Clinical and Immunological Responses: A 2-Year Follow-Up Study in Children with Allergic Rhinitis due to House Dust Mite

    NARCIS (Netherlands)

    Moed, H.; van Wijk, R.G.; Hendriks, R.W.; van der Wouden, J.C.

    2013-01-01

    Background. Allergic rhinitis is a disease with polarization towards Thand a defect of regulatory T cells. Immunological changes have been reported after immunotherapy treatment. However, there is not much known about the natural course of allergic rhinitis with respect to clinical manifestation and

  17. Clinical evaluation of failures in removable partial dentures.

    Science.gov (United States)

    Jorge, Janaina H; Quishida, Cristiane C C; Vergani, Carlos E; Machado, Ana L; Pavarina, Ana C; Giampaolo, Eunice T

    2012-01-01

    The aim of this clinical study was to evaluate the effects of removable partial dentures on the support tissues and changes occurring in lower tooth-supported and bilateral distal-extension dentures, 5 years after placement. The study involved analysis of a total of 53 patients who received prosthetic treatment for removable partial dentures. The patients were divided into two groups. In group 1, the patients had a completely edentulous maxilla and an edentulous area with natural teeth remaining in both the anterior and posterior regions. In group 2, the patients had a completely edentulous maxilla and partially edentulous mandible with preserved anterior teeth. Tooth mobility, prevalence of caries, fracture of the abutment teeth, fracture and/or deformation of the removable partial denture components and stability of the denture base were evaluated. The use of a removable partial denture increased tooth mobility, reduced the prevalence of caries, and did not cause loss or fracture of the abutments or damage to their components, when compared with the baseline. It was concluded that there was no difference between the groups as evaluated in terms of tooth mobility, prevalence of caries, loss and fracture of the abutments or damage to the components of the removable partial denture.

  18. A CLINICAL STUDY ON BLUNT INJURY ABDOMEN

    Directory of Open Access Journals (Sweden)

    G. Kishore Babu

    2016-10-01

    Full Text Available BACKGROUND Abdominal trauma continues to account for a large number of trauma-related injuries and deaths. Motor vehicle accidents and urban violence, respectively, are the leading causes of blunt and penetrating trauma to this area of the body. Unnecessary deaths and complications can be minimized by improved resuscitation, evaluation and treatment. The new techniques and diagnostic tools available are important in the management of abdominal trauma. These improved methods, however, still depend on experience and clinical judgment for application and determination of the best care for the injured patient. The aim of the study is to 1. Analyse the incidence, clinical characteristics, diagnosis, indications for laparotomy, therapeutic methods and morbidity & mortality rates. 2. To study nature of blunt abdominal trauma. 3. To assess patient for surgical intervention and to avoid negative laparotomy. 4. To assess morbidity rate in different organs injury. 5. To evaluate modalities of treatment, complications and prognosis. MATERIALS AND METHODS This study is a prospective study on 97 patients with Blunt injuries to the abdomen admitted in S.V.R.R.G.G. Hospital, Tirupati during October 2013-15. Inclusion Criteria Patients > 13 years, with Blunt injury to abdomen either by RTA, fall, object contact, assault giving written informed consent. Exclusion Criteria Patients <13 yrs. Blunt injuries due to blasts, patients with severe cardiothoracic and head injuries who are hemodynamically unstable. CONCLUSION Blunt Trauma to abdomen is on rise due to excessive use of motor vehicles. It poses a therapeutic and diagnostic dilemma for the attending surgeon due to wide range of clinical manifestations ranging from no early physical findings to progression to shock. So, the Trauma surgeon should rely on his physical findings in association with use of modalities like x-ray abdomen, USG abdomen and abdominal paracentesis. Hollow viscus perforations are

  19. Exploratory randomised controlled clinical study to evaluate the comparative efficacy of two occluding toothpastes - a 5% calcium sodium phosphosilicate toothpaste and an 8% arginine/calcium carbonate toothpaste - for the longer-term relief of dentine hypersensitivity.

    Science.gov (United States)

    Hall, Claire; Mason, Stephen; Cooke, Jonathan

    2017-05-01

    To compare the longer-term clinical efficacy of two occlusion-technology toothpastes - a 5% calcium sodium phosphosilicate (CSPS) toothpaste and a commercially available 8% arginine/calcium carbonate toothpaste - in relieving dentine hypersensitivity (DH). Efficacy was also compared with that of a regular fluoride toothpaste control. This was an exploratory, randomised, examiner-blind, parallel-group, 11-week, controlled study in healthy adults with self-reported and clinically diagnosed DH. After an acclimatisation period, subjects were randomised to one of three study treatments with which they brushed their teeth twice daily. Sensitivity was assessed at baseline and after 1, 2, 4, 6 and 11 weeks treatment in response to evaporative (air) and tactile stimuli (measured by the Schiff Sensitivity Scale/visual analogue scale and tactile threshold, respectively). A total of 135 subjects were randomised to treatment. The two occlusion-technology toothpastes performed similarly over the 11-week treatment period. All study treatments showed statistically significant reductions from baseline in DH at all timepoints for all measures (pcarbonate anti-sensitivity toothpaste provided similar benefits. Improvements in DH continued throughout the 11-week study. Dentine hypersensitivity (DH) is a common and painful condition. Twice-daily use of a 5% calcium sodium phosphosilicate toothpaste reduces DH within 1-2 weeks of initiating use. Ongoing, twice daily use of the sensitivity toothpastes evaluated in this study was associated with continued, clinically significant improvements in DH. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. [Clinical studies on flomoxef in acute tonsillitis].

    Science.gov (United States)

    Tomiyama, M

    1994-09-01

    To objectively evaluate the clinical efficacy and safety in acute tonsillitis, flomoxef (FMOX) was examined for the distribution of sensitivity of clinical strains to it and for its clinical usefulness. 1. The 80% minimum inhibitory concentration of 11 clinical strains of Gram-positive bacteria, 6 of Gram-negative bacteria and 5 of anaerobic bacteria was 0.39 microgram/ml. FMOX showed the strongest, most comprehensive antibacterial action among the drugs tested. 2. Thirty patients received FMOX. Clinical effectiveness was evaluated in 28 patients, and clinical usefulness and safety in 30. 3. The clinical efficacy rate ('excellent' and 'good') was 75% (21/28). 4. As for bacteriological response, bacterial elimination rates were 67% for Gram-positive bacteria, 100% for Gram-negative bacteria, 100% for anaerobic bacteria and 100% for mixed infections. 5. Side effects occurred in 2 (6%) patients: drug eruption and diarrhea in 1 patient each. These symptoms improved rapidly after discontinuation of the drug. 6. Although abnormal clinical test results were found in 7 (23%) patients, i.e., increases in GOT and GPT in 2, in GPT in 4 and in BUN in 1, they were transient. 7. The usefulness of FMOX was assessed in light of its efficacy and safety. It was highly satisfactory in 14 patients, satisfactory in 11, relatively satisfactory in 1, unsatisfactory in 2 and highly unsatisfactory in 2, and rate of usefulness was 83%. FMOX is considered to be highly useful for the treatment of severe acute tonsillitis.

  1. A comparative evaluation of extraction socket preservation with demineralized freeze-dried bone allograft alone and along with platelet-rich fibrin: A clinical and radiographic study

    Directory of Open Access Journals (Sweden)

    Dhaval J Thakkar

    2016-01-01

    Full Text Available Aims: To investigate clinically and radiographically, the bone fill in extraction sockets using demineralized freeze-dried bone allograft alone and along with platelet-rich fibrin (PRF. Materials and Methods: A randomized controlled clinical trial was carried out on 36 nonrestorable single-rooted teeth sites. Sites were randomized into demineralized freeze-dried bone allograft (DFDBA combined with PRF - test and DFDBA - control groups using a coin toss method. After the placement of graft material, collagen membrane was used to cover it. The clinical parameters recorded were ridge width and ridge height. All the parameters were recorded at baseline and at 90 and 180 days. Statistical Analysis Used: Independent t-test and paired t-test. Results: In both groups, there is significant reduction in loss of ridge width and ridge height from baseline to 90 days (P < 0.001, baseline to 180 days (P < 0.001, and 90-180 days (P < 0.001. However, when both the groups were compared the test group favored in the reduction of ridge width while there was no statistical difference in reduction of ridge height among at different intervals. Conclusions: Although DFDBA is considered as an ideal graft material, PRF can be used as an adjunctive with DFDBA for socket preservation.

  2. Burning mouth syndrome: Evaluation of clinical and laboratory findings.

    Science.gov (United States)

    Halac, Gulistan; Tekturk, Pinar; Eroglu, Saliha; Cikrikcioglu, Mehmet Ali; Cimendur, Ozlem; Kilic, Elif; Asil, Talip

    2016-07-30

    Burning mouth syndrome is a chronic and persistent painful condition characterized by burning sensation in the oral mucosa. We investigated the etiological factors of patients presented with the history of burning in the mouth who admitted our outpatient clinics over the 8-years period and who had no underlying identifiable local factors. We also tried to determine their demographic and clinical characteristics. Our aim was to investigate the association between burning mouth and psychiatric disorders such as depression and anxiety, chronic diseases like diabetes mellitus (DM) and other laboratory studies in patients complaining of solely burning in the mouth. The study included patients with the history of burning in mouth who presented in our outpatient clinic between 2005 and 2012. They were evaluated by a neurologist, a psychiatrist, an internist, and a dentist. Complete blood counts, biochemical analysis and cranial magnetic resonance imaging (MRI) were performed for all patients. A total of 26 (22 (84%) females, 4 (15%) males; mean age 55.9 years) patients were enrolled in this study. Five (19.2%) of the patients had depression, 2 (7.7%) had anxiety disorder, 2 (7.7%) had diabetes mellitus, 8 (30%) had B12 vitamin deficiency, 3 (11.5%) had decreased ferritin levels in blood, and 1 (3.8%) had folic acid deficiency. Cranial MRI of all patients were normal. Nine patients (34.6%) had no etiological causes. A multidisciplinary approach in the management of burning mouth and establishment of common criteria for the diagnosis would provide insight into the underlying pathophysiological mechanism.

  3. Clinical evaluation of disc battery ingestion in children.

    Science.gov (United States)

    Mirshemirani, AliReza; Khaleghnejad-Tabari, Ahmad; Kouranloo, Jaefar; Sadeghian, Naser; Rouzrokh, Mohsen; Roshanzamir, Fatolah; Razavi, Sajad; Sayary, Ali Akbar; Imanzadeh, Farid

    2012-04-01

    BACKGROUND The purpose of this study was to evaluate the characteristics, management, and outcomes of disc battery ingestion in children. METHODS We reviewed the medical records of children admitted to Mofid Children's Hospital due to disc battery ingestion from January 2006 to January 2010. Clear history, clinical symptoms and results of imaging studies revealed diagnosis of disc battery ingestion in suspected patients. The clinical data reviewed included age, gender, clinical manifestation, radiologic findings, location of disc battery, duration of ingestion, endoscopic results and surgical treatment. RESULTS We found 22 cases (11 males and 11 females) of disc battery ingestion with a mean age of 4.3 years (range: 9 months to 12 years). Common symptoms were vomiting, cough, dysphagia, and dyspnea. The mean duration of ingestion was 2.7 days (4 hours to 1.5 months). A total of 19 patients had histories of disc battery ingestion, but three cases referred with the above symptoms, and the batteries were accidentally found by x-ray. Only three cases had batteries impacted in the esophagus. Twelve batteries were removed endoscopically, 6 batteries spontaneously passed through the gastrointestinal (GI) tract within 5 to 7 days, and 4 patients underwent surgery due to complications: 3 due to tracheo-esophageal fistula (TEF) and 1 due to intestinal perforation. There was no mortality in our study. CONCLUSION Most cases of disc battery ingestion run uneventful courses, but some may be complicated. If the battery lodges in the esophagus, emergency endoscopic management is necessary. However, once in the stomach, it will usually pass through the GI tract.

  4. Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Osborn, David; Burton, Alexandra; Walters, Kate; Nazareth, Irwin; Heinkel, Samira; Atkins, Lou; Blackburn, Ruth; Holt, Richard; Hunter, Racheal; King, Michael; Marston, Louise; Michie, Susan; Morris, Richard; Morris, Steve; Omar, Rumana; Peveler, Robert; Pinfold, Vanessa; Zomer, Ella; Barnes, Thomas; Craig, Tom; Gilbert, Hazel; Grey, Ben; Johnston, Claire; Leibowitz, Judy; Petersen, Irene; Stevenson, Fiona; Hardy, Sheila; Robinson, Vanessa

    2016-02-12

    People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices. The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care. The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices. Current Controlled Trials ISRCTN13762819. Date of

  5. Development and Psychometric Evaluation of the Nursing Instructors? Clinical Teaching Performance Inventory

    OpenAIRE

    Farahani, Mansoureh A.; Ghasemi, Hormat Sadat Emamzadeh; Nikpeyma, Nasrin; Fereidouni, Zhila; Rassouli, Maryam

    2014-01-01

    Evaluation of nursing instructors? clinical teaching performance is a prerequisite to the quality assurance of nursing education. One of the most common procedures for this purpose is using student evaluations. This study was to develop and evaluate the psychometric properties of Nursing Instructors? Clinical Teaching Performance Inventory (NICTPI). The primary items of the inventory were generated by reviewing the published literature and the existing questionnaires as well as consulting wit...

  6. [Clinical evaluation of cefdinir 5% fine granules in pediatrics].

    Science.gov (United States)

    Iwai, N; Nakamura, H; Taneda, Y; Miyazu, M; Kasai, K; Watanabe, Y

    1991-10-01

    Clinical evaluation in pediatrics on cefdinir (CFDN, FK482) (5% fine granules), a new oral cephem, was performed. 1. CFDN was administered to 112 pediatric patients with ages between 1 month to 13 years with various infections. Dose levels used were 3.0-8.9 mg/kg (mean 5.1 mg/kg) t.i.d. for 3-14 days (mean 6.7 days). The studied patients included 2 patients with scarlet fever, 6 with acute pharyngitis, 6 with acute rhinopharyngitis, 52 with acute purulent tonsillitis, 8 with acute bronchitis, 24 with acute pneumonia, 7 with acute urinary tract infections, 1 with acute vaginitis, and 6 with impetigo. Total doses ranged from 0.6 to 4.05 g. One hundred eleven of the 112 patients were evaluated for clinical efficacy and all the patients were evaluated for safety. 2. Clinical effects were excellent in 51 cases, good in 57, and fair in 3 with an extremely high efficacy rate of 97.3%. Efficacy rates were 100% in scarlet fever, acute pharyngitis, acute purulent tonsillitis, acute bronchitis, acute vaginitis and impetigo, and 83.3%, 95.7%, 85.7% in acute rhinopharyngitis, acute pneumonia, and acute urinary tract infections, respectively. Good clinical effects were observed regardless of diseases. 3. Causative organisms were identified in 79 cases, of which 71 were found to be monobacterial infections and 8 were found to be multi-bacterial infections. In mono-bacterial infections, clinical efficacies were 100% for those caused by Staphylococcus aureus/Streptococcus pyogenes/Streptococcus pneumoniae/beta-Streptococcus except those in A and B groups with an overall efficacy of 100% against Gram-positive cocci (GPC) and they were 89.5%, 100%, 100% for those caused by Haemophilus influenzae, Haemophilus parainfluenzae, and Escherichia coli, respectively, with an overall efficacy of 90.3% in Gram-negative rods (GNR). In multi-bacterial infections also, a clinical efficacy of 100% was obtained. 4. Bacteriological effects were studied for 89 strains in the 79 cases. The eradication

  7. Clinical functional evaluation of female's pelvic floor: integrative review

    Directory of Open Access Journals (Sweden)

    Ana Carolina Nociti Lopes Fernandes

    2018-06-01

    Full Text Available Abstract Introduction: The effectiveness of pelvic floor muscle training (PFMT depends on the correct prescription of intensity, repetition and endurance of muscle contractions, which are provided by an adequate assessment of pelvic floor muscle. Objective: Verify the techniques, resources and strategies used for clinical functional evaluation of female pelvic floor (PF described in literature. Methods: It’s an integrative review of published studies and books from 2010 until December 2015. Relevant articles with complete description of PF evaluation were found through the use of Scielo, LILACS, PubMed and Medline databases. Results: 34 articles that fulfilled all the criteria were selected. Conclusion: The most used techniques, resources and strategies were: anamnesis, physical examination, measurement of pelvic floor muscle activity using Modified Oxford Scale or perineometry, and use of questionnaires to analyze patient's perspective of their own symptoms. Thus, we could use the parameters obtained in the evaluation to plan an ideal PFMT for each patient, so the physiotherapist would have a good database to analyze the evolution and define the end of therapy.

  8. Scaling-up access to antiretroviral therapy for children: A cohort study evaluating care and treatment at mobile and hospital-affiliated HIV clinics in rural Zambia

    NARCIS (Netherlands)

    J.H. van Dijk (Janneke); W.J. Moss (William); F. Hamangaba (Francis); B. Munsanje (Bornface); C.G. Sutcliffe (Catherine)

    2014-01-01

    textabstractBackground: Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART), but few programs have been evaluated. We compared outcomes for children receiving

  9. Evaluation of aesthetic abdominal surgery using a new clinical scale.

    Science.gov (United States)

    Salles, Alessandra Grassi; Ferreira, Marcus Castro; do Nascimento Remigio, Adelina Fatima; Gemperli, Rolf

    2012-02-01

    Evaluation of outcomes after aesthetic surgery still is a challenge in plastic surgery. The evaluation frequently is based on subjective criteria. This study used a new clinical grading scale to evaluate aesthetic results for plastic surgeries to the abdomen. The method scores each of the following five parameters: volume of subcutaneous tissue, contour, excess of skin, aspect of the navel, and quality of the scar on the abdominal wall. The scale options are 0 (poor), 1 (fair), and 2 (good), and the total rate can range from 0 to 10. The study included 40 women ages 18-53 years. Of these 40 women, 20 underwent traditional abdominoplasty, and 20 had liposuction alone. Preoperatively and at least 1 year later, photographic results were analyzed and scored by three independent plastic surgeons. In the abdominoplasty group, the average grade rose from 2.9±0.4 to 6.8±0.4 postoperatively. In the liposuction group, the average grade was 5.3±0.5 preoperatively and 7.7±0.4 postoperatively. In both groups, the average postoperative grade was significantly higher than the preoperative grade. The mean scores for groups A and L were significantly different, demonstrating that the scale was sensitive in identifying different anatomic abnormalities in the abdomen. The rating scale used for the aesthetic evaluation of the abdomen was effective in the analysis of two different procedures: conventional abdominoplasty and liposuction. Abdominoplasty provided the greater gain according to a comparison of the pre- and postoperative scores.

  10. [Clinical pilot study to evaluate the efficacy of a preservative-free hypertonic ophthalmic solution for patients with symptomatic corneal edema].

    Science.gov (United States)

    Rouland, J-F

    2015-11-01

    This exploratory clinical trial aims to assess the effect on visual acuity and central corneal thickness of an unpreserved hypertonic ophthalmic solution containing sodium chloride (5%) and sodium hyaluronate, in patients with chronic corneal edema caused by endothelial disease reducing their visual acuity. Twenty patients were enrolled and treated with the hypertonic solution (1 to 2 drops per eye, 4 times a day over 28 days). Progression of visual acuity (ETDRS score) and corneal thickness (ultrasonic pachymetry) was measured from baseline (without treatment) through the treatment period (Day 7 and Day 28). The analyses were performed on 18 patients (Full Analysis Set [FAS] population). The causes of corneal edema were Fuchs endothelial dystrophy in 10 cases and post-cataract surgery endothelial decompensation in 8 patients. The mean visual acuity values for the FAS population compared between baseline (Day-7) and one week of treatment (Day+7) show a significant 5-point VA improvement (Psolution containing sodium chloride and sodium hyaluronate significantly improved ETDRS visual acuity after one week of use. In this clinical trial, the solution also showed excellent tolerability results. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  11. Neurological abnormalities in localized scleroderma of the face and head: a case series study for evaluation of imaging findings and clinical course.

    Science.gov (United States)

    Lis-Święty, Anna; Brzezińska-Wcisło, Ligia; Arasiewicz, Hubert

    2017-09-01

    Localized scleroderma (LoS) of the face and head is often associated with neurological manifestations and/or imaging abnormalities in the central nervous system (CNS). We present an analysis of 20 cases of LoS affecting the face and head. The CNS symptoms and/or abnormalities in high-resolution computed tomography (HRCT) and/or magnetic resonance imaging (MRI) were observed in 12 patients (60%). In addition to the mild and unspecific disorders (e.g. headaches), serious neurological complications probably in the course of vasculitis were revealed: epilepsy (in two patients), epilepsy and pyramidal sings (in one patient). Neurological disorders and LoS occurred at the same time (in three patients) or at the course of the disease (nine patients) and no later than 29 years since the onset of the disease. No link between neurological disorders and the LoS clinical morphology, immunological and other laboratory parameters has been established. CNS involvement is not correlated with the clinical course of the facial and head LoS and may occur years after the disease initial symptomatology. Imaging follow-up is not required if there is not any emerging neurological symptom. In some cases, however, both HRCT and MRI are useful for monitoring disease evolution and addressing therapeutic choices.

  12. Experimental and clinical studies on CT lymphography

    International Nuclear Information System (INIS)

    Hirata, Yuzo; Kono, Michio

    1982-01-01

    Indirect lymphography using computed tomographic apparatus (CT Lymphography) was attempted in 15 dogs with newly devised contrast medium for the opacification of hilar and mediastinal lymphnodes. Clinical application was performed in 2 cases of lung cancer. Newly devised contrast material is an emulsion, which consists of oily contrast medium, non-ionic surfactant and glucose solution. The contrast medium was injected percutaneously into subdiaphragmatic space, or into bronchial walls by bronchofiberscopic technique. CT was able to demonstrate the opacified hilar and mediastinal nodes much more in number than demonstrated in conventional radiograms. It was true in 6 to 11 cases when injected into subdiaphragmatic spaces, and in 2 of 4 cases with an injection into bronchial walls. In clinical studies, CT revealed opacification of mediastinal nodes in one case of lung cancer. Although the procedure is still inferior to the demonstrability of routine indirect lymphography for the evaluation of the fine structure of each node, it showed no remarkable side effects. As the satisfactory method of opacifying hilar and mediastinal nodes has not yet been established, our method is thought to be of value in applying for detection of the metastatic lymphnodes. (author)

  13. Clinical images evaluation of mammograms: a national survey

    International Nuclear Information System (INIS)

    Moon, Woo Kyung; Kim, Tae Jung; Cha, Joo Hee

    2003-01-01

    The goal of this study was to survey the overall quality of mammographic images in Korea. A total of 598 mammographic images collected from 257 hospitals nationwide were reviewed in terms of eight images quality categories, namely positioning, compression, contrast, exposure, sharpness, noise, artifacts, and examination identification, and rated on a five-point scale: (1=severe deficiency, 2=major deficiency, 3=minor deficiency, 4=good, 5=best). Failure was defined as the occurrence of more than four major deficiencies or one severe deficiency (score of 1 or 2). The results were compared among hospitals of varying kinds, and common problems in clinical images quality were identified. Two hundred and seventeen mammographic images (36.3%) failed the evaluation. Poor images were found in descending order of frequency, at The Society for Medical Examination (33/69, 47.8%), non-radiologyclinics (42/88, 47.7%), general hospitals (92/216, 42.6%), radiology clinics (39/102, 38.2%), and university hospitals (11/123, 8.9%) (p<0.01, Chi-square test). Among the 598 images, serious problems which occurred were related to positioning in 23.7% of instances (n=142) (p<0.01, Chi-square test), examination identification in 5.7% (n=34), exposure in 5.4% (n=32), contrast in 4.2% (n=25), sharpness in 2.7% (n=16), compression in 2.5% (n=15), artifacts in 2.5% (n=15), and noise in 0.3% (n=2). This study showed that in Korea, 36.3% of the mammograms examined in this sampling had important image-related defects that might have led to serious errors in patient management. The failure rate was significantly higher in non-radiology clinics and at The Society for Medical Examination than at university hospitals

  14. CLINICAL STUDY TO EVALUATE THE VISUAL OUTCOME AND PATIENT COMFORT IN LASIK AND PHOTOREFRACTIVE KERATECTOMY IN LOW-TO-MODERATE MYOPIC ASTIGMATISM PATIENTS

    OpenAIRE

    Ashok Kumar P; Ananda Babu M; Radha Priyadharshini R; Jeevitha A

    2017-01-01

    BACKGROUND To evaluate visual outcomes following LASIK and Photorefractive Keratectomy (PRK) in low-to-moderate myopia and/or myopic astigmatism in age and refractive error matched eyes. MATERIALS AND METHODS Of a total 30 patients aged ≥21 years, 20 (40 eyes) underwent LASIK and 10 (20 eyes) underwent PRK for low-to-moderate myopia or myopic astigmatism. LASIK was performed with the Alcon wave light 500 and PRK with the alcohol application for epithelial removal. All abl...

  15. Statistical Issues in TBI Clinical Studies

    Directory of Open Access Journals (Sweden)

    Paul eRapp

    2013-11-01

    Full Text Available The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made:1. A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure.2. Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy.3. A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. 4. Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment.5. A procedure for discriminating between treatment responders and nonresponders requires, minimally, a two phase investigation. This procedure must include a

  16. Evaluating clinical teachers with the Maastricht clinical teaching questionnaire : How much 'teacher' is in student ratings?

    NARCIS (Netherlands)

    Boerboom, Tobias B. B.; Mainhard, Tim; Dolmans, Diana H. J. M.; Scherpbier, Albert J. J. A.; Van Beukelen, Peter; Jaarsma, A. D. (Debbie) C.

    2012-01-01

    Background: Students are a popular source of data to evaluate the performance of clinical teachers. Instruments to obtain student evaluations must have proven validity. One aspect of validity that often remains underexposed is the possibility of effects of between-student differences and teacher and

  17. Challenges of teacher-based clinical evaluation from nursing students' point of view: Qualitative content analysis.

    Science.gov (United States)

    Sadeghi, Tabandeh; Seyed Bagheri, Seyed Hamid

    2017-01-01

    Clinical evaluation is very important in the educational system of nursing. One of the most common methods of clinical evaluation is evaluation by the teacher, but the challenges that students would face in this evaluation method, have not been mentioned. Thus, this study aimed to explore the experiences and views of nursing students about the challenges of teacher-based clinical evaluation. This study was a descriptive qualitative study with a qualitative content analysis approach. Data were gathered through semi-structured focused group sessions with undergraduate nursing students who were passing their 8 th semester at Rafsanjan University of Medical Sciences. Date were analyzed using Graneheim and Lundman's proposed method. Data collection and analysis were concurrent. According to the findings, "factitious evaluation" was the main theme of study that consisted of three categories: "Personal preferences," "unfairness" and "shirking responsibility." These categories are explained using quotes derived from the data. According to the results of this study, teacher-based clinical evaluation would lead to factitious evaluation. Thus, changing this approach of evaluation toward modern methods of evaluation is suggested. The finding can help nursing instructors to get a better understanding of the nursing students' point of view toward this evaluation approach and as a result could be planning for changing of this approach.

  18. [How to evaluate the application of Clinical Governance tools in the management of hospitalized hyperglycemic patients: results of a multicentric study].

    Science.gov (United States)

    De Belvis, Antonio Giulio; Specchia, Maria Lucia; Ferriero, Anna Maria; Capizzi, Silvio

    2017-01-01

    Risk management is a key tool in Clinical Governance. Our project aimed to define, share, apply and measure the impact of tools and methodologies for the continuous improvement of quality of care, especially in relation to the multi-disciplinary and integrated management of the hyperglycemic patient in hospital settings. A training project, coordinated by a scientific board of experts in diabetes and health management and an Expert Meeting with representatives of all the participating centers was launched in 2014. The project involved eight hospitals through the organization of meetings with five managers and 25 speakers, including diabetologists, internists, pharmacists and nurses. The analysis showed a wide variability in the adoption of tools and processes towards a comprehensive and coordinated management of hyperglycemic patients.

  19. Considerations for Clinical Neuropsychological Evaluation in Amyotrophic Lateral Sclerosis.

    Science.gov (United States)

    Woolley, Susan C; Rush, Beth K

    2017-11-01

    The clinical neuropsychologist has the opportunity to be uniquely involved in the evaluation and treatment of individuals with amyotrophic lateral sclerosis (ALS). We review the current literature that defines cognitive and behavioral symptoms in ALS, including current knowledge of the neuropathological and genetic underpinning for these symptoms. There are unique considerations for clinical neuropsychological evaluation and clinical research in ALS and we highlight these in this review. Specifically, we shed light on special factors that contribute to our understanding of cognitive and behavioral impairment in ALS, including co-morbid symptoms, differential diagnosis, and considerations for longitudinal tracking of phenotypes. We discuss the rationale for proposing a specific approach to such as cognitive screening, test selection, response modality consideration, and test-retest intervals. With this didactic overview, the clinical neuropsychologist has the potential to learn more about the heterogeneous presentation of motor and neuropsychological symptoms in ALS. Furthermore, the reader has the opportunity to understand what it takes to develop a valid assessment approach particularly when the phenotype of ALS remains undefined in some regards. This clinical practice review sets the stage for the clinical neuropsychologist to further contribute to our clinical and scientific understanding of ALS and cognition. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  20. Clinical studies of biomarkers in suicide prediction

    OpenAIRE

    Jokinen, Jussi

    2007-01-01

    Suicide is a major clinical problem in psychiatry and suicidal behaviours can be seen as a nosological entity per se. Predicting suicide is difficult due to its low base-rate and the limited specificity of clinical predictors. Prospective biological studies suggest that dysfunctions in the hypothalamo pituitary adrenal (HPA) axis and the serotonergic system have predictive power for suicide in mood disorders. Suicide attempt is the most robust clinical predictor making suici...

  1. Effectiveness of faculty training to enhance clinical evaluation of student competence in ethical reasoning and professionalism.

    Science.gov (United States)

    Christie, Carole; Bowen, Denise; Paarmann, Carlene

    2007-08-01

    This study evaluated the short- and long-term effectiveness of faculty training to enhance clinical evaluation of ethical reasoning and professionalism in a baccalaureate dental hygiene program. Ethics, values, and professionalism are best measured in contexts comparable to practice; therefore, authentic evaluation is desirable for assessing these areas of competence. Methods were the following: 1) a faculty development workshop implementing a core values-based clinical evaluation system for assessing students' professional judgment; 2) subsequent evaluation of the clinical faculty's use of core values for grading and providing written comments related to students' professional judgment during patient care for three academic years; and 3) evaluation of program outcomes assessments regarding clinical learning experiences related to ethics and professionalism domains. Results revealed the clinical faculty's evaluation of professional judgment during patient care was enhanced by training; written comments more frequently related to core values defined in the American Dental Hygienists' Association (ADHA) Code of Ethics; and faculty members reported more confidence and comfort evaluating professional judgment after implementation of this evaluation system and receiving training in its application. Students were more positive in outcomes assessments about their competency and learning experiences related to professionalism and ethics. This article shares one approach for enhancing clinical faculty's authentic evaluation of student competence in ethical reasoning and professionalism.

  2. CLINICAL STUDY OF DUODENAL PERFORATION

    Directory of Open Access Journals (Sweden)

    Sambasiva Rao

    2016-04-01

    Full Text Available BACKGROUND The duodenal injury can pose a formidable challenge to the surgeon and failure to manage it properly may have devastating results. Over the centuries, there was little to offer the patient of acute abdomen beyond cupping, purgation and enemas, all of which did more harm than good. It was not until 1884 that Mikulicz made an attempt to repair a perforation. Recent statistics indicate roughly 10% of population develop gastric or duodenal ulcer in life time. Roughly 1-3% of population above the age of 20 years have some degree of peptic ulcer activity during any annual period. A detailed history with regards to the signs and symptoms of the patient, a meticulous examination, radiological and biochemical investigations help to arrive at a correct preoperative diagnosis. In this study, a sincere effort has been put to understand the demographic patterns, to understand the underlying aetiology and to understand the effectiveness of the standard methods of investigation and treatment in use today. METHODS This is a 24 months prospective study i.e., from September 2011 to September 2013 carried out at Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation. The study included the patients presenting to Dr. Pinnamaneni Siddhartha Institute of Medical Sciences & Research Foundation to emergency ward with signs and symptoms of hollow viscus perforation. The sample size included 30 cases of duodenal perforation. RESULTS Duodenal ulcer perforation commonly occurs in the age group of 30-60 years, but it can occur in any age group. Majority of the patients were male. Smoking and alcohol consumption were risk factors in most cases (53.3% for the causation of duodenal ulcer perforation. Sudden onset of abdominal pain, situated at epigastrium and right hypochondrium was a constant symptom (100%. Vomiting, constipation and fever were not so common. CONCLUSION The emergency surgical management for perforated duodenal ulcer is by

  3. Korean Clinic Based Outcome Measure Studies

    OpenAIRE

    Jongbae Park

    2003-01-01

    Background: Evidence based medicine has become main tools for medical practice. However, conducting a highly ranked in the evidence hierarchy pyramid is not easy or feasible at all times and places. There remains a room for descriptive clinical outcome measure studies with admitting the limit of the intepretation. Aims: Presents three Korean clinic based outcome measure studies with a view to encouraging Korean clinicians to conduct similar studies. Methods: Three studies are presented...

  4. Clinical Study of Second Branchial Cleft Anomalies.

    Science.gov (United States)

    Lee, Dong Hoon; Yoon, Tae Mi; Lee, Joon Kyoo; Lim, Sang Chul

    2018-03-30

    The objective of this study was to review the clinical characteristics and surgical treatment outcomes of second branchial cleft anomalies, and to evaluate the usefulness and accuracy of preoperative fine-needle aspiration cytology (FNAC) in the diagnosis of branchial cleft cysts. A retrospective chart review was performed at Chonnam National University Hwasun Hospital from January 2010 to December 2016. Among 25 patients with second branchial cleft anomalies, in 23 patients (92.0%), these anomalies presented as cysts, and in the remaining 2 patients (8.0%), these anomalies presented as fistulas. Fine-needle aspiration cytology had a diagnostic sensitivity of 100%, a positive-predictive value of 100%, and accuracy of 100% for diagnosing second branchial cleft cyst. All patients of second branchial cleft anomalies were treated surgically under general anesthesia. No recurrence of second branchial cleft anomalies was observed. Branchial cleft cysts were the most common type of second branchial cleft anomalies. Preoperative FNAC is a useful and accurate method for preoperative evaluation of branchial cleft cysts. Surgical excision of second branchial cleft anomalies is the treatment of choice without any complications and with no recurrence.

  5. Using a New Measurement to Evaluate Pain Relief Among Cancer Inpatients with Clinically Significant Pain Based on a Nursing Information System: A Three-Year Hospital-Based Study.

    Science.gov (United States)

    Wang, Wei-Yun; Chu, Chi-Ming; Sung, Chun-Sung; Ho, Shung-Tai; Wu, Yi-Syuan; Liang, Chun-Yu; Wang, Kwua-Yun

    2016-11-01

    Developing a new measurement index is the first step in evaluating pain relief outcomes. Although the percentage difference in pain intensity (%PID) is the most popular indicator, this indicator does not take into account the goal of pain relief. Therefore, the aims of this study were to develop a pain relief index (PRI) for outcome evaluation and to examine the index using demographic characteristics of cancer inpatients with clinically significant pain. Retrospective cohort study. A national hospital. All cancer inpatients. Pain intensity was assessed using a numerical rating scale, a faces pain scale or the Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Tool. Using a nursing information system, a pain score database containing data from 2011 through 2013 was analyzed. Cancer patients representing 93,812 hospitalizations were considered in this study. We focused on cancer patients for whom the worst pain intensity (WPI) was ≥ 4 points. PRI values of -62.02% to -72.55% were observed in the WPI ≥ 7 and 4 ≤ WPI ≤ 6 groups. Significant (P 65 years old, those who were admitted to the medicine or gynecology and those who had a hospital stay > 30 days. This hospital-based study demonstrated that the PRI is an effective and valid measure for evaluating outcome data using an electronic nursing information system. We will further define the meaningful range of percentage difference in PRI from various perspectives. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  6. Evaluation of the Clinical Data Dictionary (CiDD)

    Science.gov (United States)

    Lee, Myung Kyung; Min, Yul Ha; Kim, Younglan; Min, Hyo Ki; Ham, Sung Woo

    2010-01-01

    Objectives The purpose of the study was to evaluate content coverage and data quality of the Clinical Data Dictionary (CiDD) developed by the Center for Interoperable EHR (CiEHR). Methods A total of 12,994 terms were collected from 98 clinical forms of a tertiary cancer center hospital with 500 beds. After data cleaning, 9,418 terms were mapped with the data items of the CiDD by the research team, and validated by 30 doctors and nurses at the research hospital. Results Mapping results were classified into five categories: lexically mapped; semantically mapped; mapped to either a broader term or a narrower term; mapped to more than one term and not mapped. In terms of coverage, out of 9,418 terms, 6,750 (71.7%) terms were mapped; 4,319 (45.9%) terms were lexically mapped; 2,431 (25.8%) were semantically mapped; 281 (3.0%) terms were mapped to a broader term; 43 (0.5%) were mapped to a narrower term; and 550 (5.8%) were mapped to more than one term. In terms of data quality, the CiDD has problems such as errors in concept namingand representation, redundancy in synonyms, inadequate synonyms, and ambiguity in meaning. Conclusions Although the CiDD has terms covering 72% of local clinical terms, the CiDD can be improved by cleaning up errors and redundancies, adding textual definitions or use cases of the concept, and arranging the concepts in a hierarchy. PMID:21818428

  7. Group clinics for young adults with diabetes in an ethnically diverse, socioeconomically deprived setting (TOGETHER study): protocol for a realist review, co-design and mixed methods, participatory evaluation of a new care model.

    Science.gov (United States)

    Papoutsi, Chrysanthi; Hargreaves, Dougal; Colligan, Grainne; Hagell, Ann; Patel, Anita; Campbell-Richards, Desirée; Viner, Russell M; Vijayaraghavan, Shanti; Marshall, Martin; Greenhalgh, Trisha; Finer, Sarah

    2017-06-21

    Young adults with diabetes often report dissatisfaction with care and have poor diabetes-related health outcomes. As diabetes prevalence continues to rise, group-based care could provide a sustainable alternative to traditional one-to-one consultations, by engaging young people through life stage-, context- and culturally-sensitive approaches. In this study, we will co-design and evaluate a group-based care model for young adults with diabetes and complex health and social needs in socioeconomically deprived areas. This participatory study will include three phases. In phase 1, we will carry out a realist review to synthesise the literature on group-based care for young adults with diabetes. This theory-driven understanding will provide the basis for phase 2, where we will draw on experience-based co-design methodologies to develop a new, group-based care model for young adults (aged researcher-in-residence approach to implement and evaluate the co-designed group clinic model and compare with traditional care. We will employ qualitative (observations in clinics, patient and staff interviews and document analysis) and quantitative methods (eg, biological markers, patient enablement instrument and diabetes distress scale), including a cost analysis. National Health Service ethics approval has been granted (reference 17/NI/0019). The project will directly inform service redesign to better meet the needs of young adults with diabetes in socioeconomically deprived areas and may guide a possible cluster-randomised trial, powered to clinical and cost-effectiveness outcomes. Findings from this study may be transferable to other long-term conditions and/or age groups. Project outputs will include briefing statements, summaries and academic papers, tailored for different audiences, including people living with diabetes, clinicians, policy makers and strategic decision makers. PROSPERO (CRD42017058726). © Article author(s) (or their employer(s) unless otherwise stated in the

  8. [Clinical evaluation of a novel HBsAg quantitative assay].

    Science.gov (United States)

    Takagi, Kazumi; Tanaka, Yasuhito; Naganuma, Hatsue; Hiramatsu, Kumiko; Iida, Takayasu; Takasaka, Yoshimitsu; Mizokami, Masashi

    2007-07-01

    The clinical implication of the hepatitis B surface antigen (HBsAg) concentrations in HBV-infected individuals remains unclear. The aim of this study was to evaluate a novel fully automated Chemiluminescence Enzyme Immunoassay (Sysmex HBsAg quantitative assay) by comparative measurements of the reference serum samples versus two independent commercial assays (Lumipulse f or Architect HBsAg QT). Furthermore, clinical usefulness was assessed for monitoring of the serum HBsAg levels during antiviral therapy. A dilution test using 5 reference-serum samples showed linear correlation curve in range from 0.03 to 2,360 IU/ml. The HBsAg was measured in total of 400 serum samples and 99.8% had consistent results between Sysmex and Lumipulse f. Additionally, a positive linear correlation was observed between Sysmex and Architect. To compare the Architect and Sysmex, both methods were applied to quantify the HBsAg in serum samples with different HBV genotypes/subgenotypes, as well as in serum contained HBV vaccine escape mutants (126S, 145R). Correlation between the methods was observed in results for escape mutants and common genotypes (A, B, C) in Japan. Observed during lamivudine therapy, an increase in HBsAg and HBV DNA concentrations preceded the aminotransferase (ALT) elevation associated with drug-resistant HBV variant emergence (breakthrough hepatitis). In conclusion, reliability of the Sysmex HBsAg quantitative assay was confirmed for all HBV genetic variants common in Japan. Monitoring of serum HBsAg concentrations in addition to HBV DNA quantification, is helpful in evaluation of the response to lamivudine treatment and diagnosis of the breakthrough hepatitis.

  9. Clinical study of CT colonography

    International Nuclear Information System (INIS)

    Nakazawa, Saburo; Hattori, Toshiyuki; Inui, Kazuo

    2011-01-01

    We studied the usefulness of CT colonography (CTC) for colon cancer diagnosis. CTC and optical colonoscopy were performed for 150 cases mainly including patients with a positive fecal occult blood test (FOBT). The results were compared and analyzed. The following are the final diagnoses given to the patients: advanced colon cancer: 41 cases; early cancer: 25 cases; adenoma: 74 cases; hyperplasia: 3 cases; submucosal tumor: 1 case; and no lesion: 6 cases. In terms of diagnostic performance of CTC, accuracy was found to be 96%, sensitivity was found to be 97.9%, and specificity was found to be 50%. Cancer stage-specific sensitivity was as follows: advanced colon cancer: 100%; early cancer: 96.3%; adenoma: 71.2%; and hyperplasia: 47.4%. Lesion site-specific sensitivity was as follows: caecum: 76.2%; ascending colon: 57.6%; transverse colon: 66.2%; descending colon: 83.3%; sigmoid colon: 85.1%; and rectum: 78.0%. Lesion size-specific sensitivity was as follows: 2 to 5 mm: 56.7%; 6 to 9 mm: 88.1%; 10 mm or more: 92.5%; and 6 mm or more: 90.9%. Therefore, the diagnostic sensitivity of CTC was confirmed to be high. The results suggest that CTC would be useful for colon cancer screening. (author)

  10. Assessment and Evaluation of Quality of Life (OHRQoL) of Patients with Dental Implants Using the Oral Health Impact Profile (OHIP-14) - A Clinical Study.

    Science.gov (United States)

    Alzarea, Bader K

    2016-04-01

    Peri-implant tissue health is a requisite for success of dental implant therapy. Plaque accumulation leads to initiation of gingivitis around natural teeth and peri-implantitis around dental implants. Peri-implantitis around dental implants may result in implant placement failure. For obtaining long-term success, timely assessment of dental implant site is mandatory. To assess and evaluate Quality of Life (OHRQoL) of individuals with dental implants using the Oral Health Impact Profile (OHIP-14). Total 92 patients were evaluated for assessment of the health of peri-implant tissues by recording, Plaque Index (PI), Probing Pocket Depth (PD), Bleeding On Probing (BOP) and Probing Attachment Level (PAL) as compared to contra-lateral natural teeth (control). In the same patients Quality of Life Assessment was done by utilizing Oral Health Impact Profile Index (OHIP-14). The mean plaque index around natural teeth was more compared to implants and it was statistically significant. Other three dimensions mean bleeding on probing; mean probing attachment level and mean pocket depth around both natural teeth and implant surfaces was found to be not statistically significant. OHIP-14 revealed that patients with dental implants were satisfied with their Oral Health-Related Quality of Life (OHRQoL). Similar inflammatory conditions are present around both natural teeth and implant prostheses as suggested by results of mean plaque index, mean bleeding on probing, mean pocket depth and mean probing attachment level, hence reinforcing the periodontal health maintenance both prior to and after incorporation of dental implants. Influence of implant prostheses on patient's oral health related quality of life (as depicted by OHIP-14) and patients' perceptions and expectations may guide the clinician in providing the best implant services.

  11. Clinical implementation and evaluation of the Acuros dose calculation algorithm.

    Science.gov (United States)

    Yan, Chenyu; Combine, Anthony G; Bednarz, Greg; Lalonde, Ronald J; Hu, Bin; Dickens, Kathy; Wynn, Raymond; Pavord, Daniel C; Saiful Huq, M

    2017-09-01

    The main aim of this study is to validate the Acuros XB dose calculation algorithm for a Varian Clinac iX linac in our clinics, and subsequently compare it with the wildely used AAA algorithm. The source models for both Acuros XB and AAA were configured by importing the same measured beam data into Eclipse treatment planning system. Both algorithms were validated by comparing calculated dose with measured dose on a homogeneous water phantom for field sizes ranging from 6 cm × 6 cm to 40 cm × 40 cm. Central axis a