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Sample records for clinical evaluation study

  1. Clinical Applications of Evaluation Studies.

    ERIC Educational Resources Information Center

    Brown, Barry S.

    A series of followup investigations exploring the impact of methadone maintenance treatment, methadone detoxification treatment, therapeutic communities, and outpatient drug-free treatment for the drug abuser was conducted. Limitations of these modalities were revealed in the followup studies. Implications for treatment and policy include: (1)…

  2. Evaluation systems for clinical governance development: a comparative study.

    PubMed

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

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  3. Clinical evaluation of hypnotic drugs: contributions from sleep laboratory studies.

    PubMed

    Kales, A; Scharf, M B; Soldatos, C R; Bixler, E O

    1979-07-01

    The most thorough and clinically relevant approach to hypnotic drug evaluation is one that balances the strengths and weaknesses of clinical trials and sleep laboratory evaluations. Advantages of clinical trials include the ability to evaluate large numbers of subjects and specific target groups and to thoroughly assess and quantify a drug's side effects, whereas sleep laboratory studies are very limited in all of these areas. Sleep laboratory studies however provide a rigorous, precise, and comprehensive profile of a drug's activity since there is more control over experimental variables and measurements are objective as well as continuous throughout the night. These benefits offset the shortcomings of clinical trials, which include a lack of objective measurements, less control over experimental variables, failure to evaluate a drug's effectiveness with continued use, and inattention to drug interaction and withdrawal effect. Several basic principles derived from sleep laboratory findings have been incorporated into both the clinical trials and sleep laboratory evaluations recommended in the new FDA Guidelines for the Clinical Evaluation of Hypnotic Drugs. These principles include provision for adequate baseline and withdrawal periods, use of multiple consecutive drug nights to assess a drug's effectiveness with continued use, and inclusion of an adequate washout period when a cross-over design is used. The guidelines do not emphasize either clinical trials or sleep laboratory studies at the expense of each other, but rather stress their complementary utilization.

  4. Validation of a virtual preoperative evaluation clinic: a pilot study.

    PubMed

    Zetterman, Corey V; Sweitzer, Bobbie J; Webb, Brad; Barak-Bernhagen, Mary A; Boedeker, Ben H

    2011-01-01

    Patients scheduled for surgery at the Omaha VA Medical Center were evaluated preoperatively via telemedicine. Following the examination, patients filled out a 15 item, 5 point Likert scale questionnaire regarding their opinion of preoperative evaluation in a VTC format. Evaluations were performed under the direction of nationally recognized guidelines and recommendations of experts in the field of perioperative medicine and were overseen by a staff anesthesiologist from the Omaha VA Medical Center. No significant difficulties were encountered by the patient or the evaluator regarding the quality of the audio/visual capabilities of the VTC link and its ability to facilitate preoperative evaluation. 87.5% of patients felt that virtual evaluation would save them travel time; 87.5% felt virtual evaluation could save them money; 7.3% felt uncomfortable using the VTC link; 12.2% felt the virtual evaluation took longer than expected; 70.7% preferred to be evaluated via VTC link; 21.9% were undecided; 9.7% felt they would rather be evaluated face-to-face with 26.8% undecided; 85.0% felt that teleconsultation was as good as being seen at the Omaha surgical evaluation unit; 7.5% were undecided. Our study has shown that effective preoperative evaluation can be performed using a virtual preoperative evaluation clinic; patients are receptive to the VTC format and, in the majority of cases, prefer it to face-to-face evaluation.

  5. [Analysis on evaluation tool for literature quality in clinical study].

    PubMed

    Liu, Qing; Zhai, Wei; Tan, Ya-qin; Huang, Juan

    2014-09-01

    The tools used for the literature quality evaluation are introduced. The common evaluation tools that are publicly and extensively used for the evaluation of clinical trial literature quality in the world are analyzed, including Jadad scale, Consolidated Standards of Reporting Trials (CONSORT) statement and Grades of Recommendations Assessment, Development and Evaluation (GRADE) system and the others. Additionally, the present development, updates and applications of these tools are involved in analysis.

  6. An Alternative Study of Transfer of Learning in Clinical Evaluation.

    ERIC Educational Resources Information Center

    Patel, Vimla; Cranton, Patricia A.

    The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

  7. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Committee advises the Chief Research and Development Officer through the Director of the Clinical...

  8. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  9. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Research and Development Officer through the Director of the Clinical Science Research and...

  10. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  11. Evaluating outpatient transition clinics: a mixed-methods study protocol

    PubMed Central

    Sattoe, Jane N T; Peeters, Mariëlle A C; Hilberink, Sander R; Ista, Erwin; van Staa, AnneLoes

    2016-01-01

    Introduction To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC). Methods and analysis We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care. Ethics The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246). Dissemination Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016

  12. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Science Research and Development Service on the relevance and feasibility of proposed projects and...

  13. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... No: 2012-12522] DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service... Science Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held... Research and Development Officer through the Director of the Clinical Science Research and...

  14. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  15. Sonographic evaluation of lipohemarthrosis: clinical and in vitro study.

    PubMed

    Bianchi, S; Zwass, A; Abdelwahab, I F; Ricci, G; Rettagliata, F; Olivieri, M

    1995-04-01

    The purpose of this study is to evaluate the role of sonography in diagnosing lipohemarthrosis. Sonography was performed on seven patients with intra-articular fractures of the knee, shoulder, and hip. An in vitro mixture of fat and blood was examined as the gold standard. In the patients scanned a few minutes after immobilization, a two-band appearance of joint effusion was present, representing a fat-blood level. One patient scanned 3 hours after immobilization showed a three-band appearance of joint effusion, corresponding to the layers of fat, serum and red blood cells. Results of this study indicate a high reliability of ultrasonography in detecting lipohemarthrosis.

  16. [Clinical application of extracts of Echinacea purpurea or Echinacea pallida. Critical evaluation of controlled clinical studies].

    PubMed

    Dorsch, W

    1996-04-01

    The phytotherapy should be understood as being integrated into the rational pharmacotherapy. The modern phytotherapy tries hard to proof effects with pharmacological and clinical studies. The task force E of the federal bureau of health of Germany has made a statement regarding this problem. This article reviews only controlled clinical trials about the application of extracts of echinacea purpura or echinacea pallida.

  17. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects...

  18. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Research and Development Officer through the Director of the Clinical Science Research and...

  19. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... the Director of the Clinical Science Research and Development Service on the relevance and...

  20. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Chief Research and Development Officer through the Director of the Clinical Science Research...

  1. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    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…

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

    PubMed Central

    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

  3. An evaluation of the clinical potential of tissue diffraction studies

    NASA Astrophysics Data System (ADS)

    Speller, R.; Abuchi, S.; Zheng, Y.; Vassiljev, N.; Konstantinidis, A.; Griffiths, J.

    2015-09-01

    Medical imaging is a long established part of patient management in the treatment of disease. However, in most cases it only provides anatomical detail and does not provide any form of tissue characterisation. This is particularly true for X-ray imaging. Recent studies on tissue diffraction have shown that true molecular signatures can be derived for different tissue types. Breast cancer samples and liver tissue have been studied. It has been shown that diffraction profiles can be traced away from the primary tumour in excised breast tissue samples and that potentially 3mm fat nodules in liver tissue can be identified in patients at acceptable doses.

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

    PubMed

    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.

  5. Two-year clinical evaluation of resin composite in posterior teeth: A randomized controlled study

    PubMed Central

    Gianordoli-Neto, Ranulfo; Padovani, Gislaine Cristina; Mondelli, José; de Lima Navarro, Maria Fidela; Mendonça, Juliano Sartori; Santiago, Sérgio Lima

    2016-01-01

    Background: Clinical evaluations as fundamental method to prove the efficiency of restorative materials. Aim: This study evaluated the clinical performance of restorative systems during 2 years of clinical service. Materials and Methods: This study assessed the clinical performance of restorative systems (Filtek Z250 and P60), during 2 years of clinical service, using the US Public Health Service system. The randomized and double-blind study comprising thirty volunteers. The restorations were evaluated at baseline, 6, 12, and 24 months. It was used the following criteria: marginal discoloration (MD), marginal integrity (MI), superficial texture (ST), wear (W), postoperative sensitivity (PS) and recurrent caries (RC). Results: Statistic analysis was performed using Fisher's and McNemar's exact tests and Pearsons's Chi-square in a significance level of 5%. The results at baseline and 24 months for Group I were: MD – 100, 100%; MI – 100, 88.6%; ST – 100, 94.3%; W – 100, 94.3%; PS – 100, 100%; RC – 100, 100%, of alpha scores; Group II: MD – 100, 97.1%; MI – 100, 91.4%; ST – 100, 94.3%; W – 100, 91.4%; PS – 100, 100%; RC – 100, 100%, of alpha scores. It was observed no statistical difference in the evaluated criteria and period. Conclusions: After 24 months of evaluation, both restorative systems exhibited acceptable clinical performance. PMID:27563176

  6. First Results Of The Diagnostic Evaluation Studies And The Clinical Efficacy Evaluation In The Dutch PACS Project

    NASA Astrophysics Data System (ADS)

    Barneveld Binkhuysen, F. H.; Ottes, F. P.; ter Haar Romeny, B. M.; Klessens, P. L. M.; Vos, C. G.; Winter, L. H. L.; Calkoen, P. T.; Andriessen, J. H. T. H.

    1989-05-01

    The objective of the studies was to evaluate the diagnostic performance of the image digitizing distribution and display equipment of the installed PACS (Philips) in the Utrecht University Hospital (see also procee-dings SPIE 914, 1988). The diagnostic accuracy was evaluated by means of observer performance studies, using ROC analysis. Three series of films were used: chest phantom radiographs, clinical mammographic films, and clinical head CT's. We compared: original films versus images digitized with a video scanner, and/or original films versus images digitized with a laser scanner. Both scanners have 1024x1024x8 bits output resolution. Four radiologists scored the presence on a 5-point scale. The results of the mammographic and head CT series will be presented in this paper. The results of the diagnostic accuracy studies of the chest radiographs and their specific methodology will be presented in a companion SPIE paper. Goal of the clinical efficacy study is to see if the use of a PACS multimodality viewing station at an internal ward has clinical advantages as compared to the conventional situation. Using PACS integrated with a HIS (including a RIS) more easier and faster information is accessible to the clinicians. In this paper we will describe: the procedures which are needed to evaluate the use of the workstation installed at the internal ward, the development of the user interface with four layers of the Image Management System, and the methodology of evaluation the clinical advantages.

  7. STP Best Practices for Evaluating Clinical Pathology in Pharmaceutical Recovery Studies.

    PubMed

    Tomlinson, Lindsay; Ramaiah, Lila; Tripathi, Niraj K; Barlow, Valerie G; Vitsky, Allison; Poitout-Belissent, Florence M; Bounous, Denise I; Ennulat, Daniela

    2016-02-01

    The Society of Toxicologic Pathology formed a working group in collaboration with the American Society for Veterinary Clinical Pathology to provide recommendations for the appropriate inclusion of clinical pathology evaluation in recovery arms of nonclinical toxicity studies but not on when to perform recovery studies. Evaluation of the recovery of clinical pathology findings is not required routinely but provides useful information on risk assessment in nonclinical toxicity studies and is recommended when the ability of the organ to recover is uncertain. The study design generally requires inclusion of concurrent controls to separate procedure-related changes from test article-related changes, but return of clinical pathology values toward baseline may be sufficient in some cases. Evaluation of either a select or full panel of standard hematology, coagulation, and serum and urine chemistry biomarkers can be scientifically justified. It is also acceptable to redesignate dosing phase animals to the recovery phase or vice versa to optimize data interpretation. Assessment of delayed toxicity during the recovery phase is not required but may be appropriate in development programs with unique concerns. Evaluation of the recovery of clinical pathology data for vaccine development is required and, for efficacy markers, is recommended if it furthers pharmacologic understanding.

  8. [Evaluation of secondary care in oral health: a study of specialty clinics in Brazil].

    PubMed

    Goes, Paulo Sávio Angeiras de; Figueiredo, Nilcema; Neves, Jerlucia Cavalcanti das; Silveira, Fabiana Moura da Motta; Costa, José Felipe Riani; Pucca Júnior, Gilberto Alfredo; Rosales, Maritza Sosa

    2012-01-01

    This article discusses the evaluation of secondary care in the area of health surveillance. This was a descriptive and normative/evaluative study. Performance analysis drew on secondary data, based on a historical series of dental procedures conducted at the specialized dental clinics implemented in Brazil and recorded by the Outpatient Information System of the Unified National Health System (SIA/SUS) in 2007, as well as primary data from site visits to the clinics, based on questionnaires completed by clinic staff. Performance of the clinics was poor in most regions of the country, and the North of Brazil had the lowest percentage of specialty services implemented. The indicator "Performance of Secondary Care in Oral Health" was 64.4%. The type 3 specialty clinics showed better results in terms of performance and achievement of targets. The study showed the need to review the legal framework for implementing specialized dental clinics by adjusting the criteria and norms, as well as definition of new standards for achievement of goals in the evaluation and monitoring of these services.

  9. Evaluation of the IVAC 560 volumetric pump. A clinical and laboratory study.

    PubMed

    Hutchinson, A; Yeoman, P M; Byrne, A J

    1985-10-01

    The performance of a new combined infusion pump and central venous pressure monitor, the IVAC 560, has been evaluated in laboratory and clinical studies. The pump performed accurately and reliably, and the pressure readings obtained from the pump correlated well with conventional methods of pressure measurement, although they lost accuracy when using 50% dextrose at higher venous pressures.

  10. Evaluating Creative Thinking of Rn-Bsn Students in the Course of Clinical Case Study and Practicum

    ERIC Educational Resources Information Center

    Ku, Ya-Lie

    2015-01-01

    This case study evaluated creative thinking of RN-BSN students in the course of clinical case study and practicum. Study design used quantitative and qualitative evaluations of creative thinking of RN-BSN students by triangulation method in the course of clinical case study and practicum. Sixty RN-BSN students self-perceived the changing levels of…

  11. Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity

    PubMed Central

    Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

    2016-01-01

    Abstract Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery. Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0–100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis. Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th–75th percentiles: 10–52) versus 21 (10–46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men. This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies. PMID:27399095

  12. Clinical Evaluation of Tinnitus.

    PubMed

    Hertzano, Ronna; Teplitzky, Taylor B; Eisenman, David J

    2016-05-01

    The clinical evaluation of patients with tinnitus differs based on whether the tinnitus is subjective or objective. Subjective tinnitus is usually associated with a hearing loss, and therefore, the clinical evaluation is focused on an otologic and audiologic evaluation with adjunct imaging/tests as necessary. Objective tinnitus is divided into perception of an abnormal somatosound or abnormal perception of a normal somatosound. The distinction between these categories is usually possible based on a history, physical examination, and audiogram, leading to directed imaging to identify the underlying abnormality.

  13. Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

    PubMed

    Hayakawa, Yoshihiro; Kawada, Manabu; Nishikawa, Hiroyoshi; Ochiya, Takahiro; Saya, Hideyuki; Seimiya, Hiroyuki; Yao, Ryoji; Hayashi, Masahiro; Kai, Chieko; Matsuda, Akira; Naoe, Tomoki; Ohtsu, Atsushi; Okazaki, Taku; Saji, Hideo; Sata, Masataka; Sugimura, Haruhiko; Sugiyama, Yuichi; Toi, Masakazu; Irimura, Tatsuro

    2016-02-01

    Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.

  14. Fraser syndrome: a clinical study of 59 cases and evaluation of diagnostic criteria.

    PubMed

    van Haelst, Mieke M; Scambler, Peter J; Hennekam, Raoul C M

    2007-12-15

    Fraser syndrome is an autosomal recessive congenital malformation syndrome characterized by cryptophthalmos, syndactyly, and urogenital defects. We studied the clinical features in 59 affected individuals from 40 families (25 consanguineous), and compared our findings to data from previous reviews. We found a higher frequency of abnormalities of the skull, larynx, umbilicus, urinary tract, and anus in our series of patients, and mental retardation and cleft lip with or without cleft palate were observed less frequently than previously reported. Clinical features in probands and sibs were remarkably similar. As can be expected prenatally diagnosed patients had more manifestations that gave rise to a pathological amount of amniotic fluid. Otherwise patients diagnosed before and after birth had similar frequencies of symptoms. Based on the present results we suggest an adaptation of diagnostic criteria for FS, including adding airway tract and urinary tract anomalies as major criteria. The specificity of the proposed diagnostic criteria was evaluated using the London Medical Database as a search tool.

  15. Evaluation of metronidazole nanofibers in patients with chronic periodontitis: A clinical study

    PubMed Central

    Chaturvedi, Thakur Prasad; Srivastava, Ruchi; Srivastava, Anand Kumar; Gupta, Varun; Verma, Pushpendra Kumar

    2012-01-01

    Aim: Prevention of periodontal disease progression is the primary goal of periodontal therapy. When conventional therapy is found to be inadequate in achieving periodontal health in chronic periodontitis, local antimicrobial agents are used as an adjunct to scaling and root planing (SRP), which produces encouraging results. In the present study, an attempt was made to develop a low-dose controlled-release delivery system for the treatment of periodontal infections. A new sustained release drug system of poly e-caprolactone (PCL) nanofibers containing metronidazole (MET) was successfully electrospun and evaluated clinically for periodontal diseases. The retentive nanofibres were shown to provide a controlled delivery of the drugs. Materials and Methods: Nanofibers were prepared with MET in PCL by electrospinning technique. The drug-coated nanofibers provided sustained effect up to a period of 11 days (264 h) and followed first-order release. Forty sites in seven patients (four females and three males) with chronic periodontitis (5–8 mm probing depth) were allocated in two experimental treatment groups: Group A treated with SRP + MET nanofibers and Group B treated with SRP alone (control group). All these patients were evaluated clinically for probing depth (PD), plaque index (PI), and gingival index (GI). Results: Both the treatment groups were found to be efficacious in the treatment of periodontal disease as demonstrated by improvement in PD, PI, and GI. Conclusion: Combination of SRP + MET nanofibers (Group A) resulted in added benefits, compared to the control group. PMID:23580938

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

    PubMed Central

    Guerra, Fabrizio; Mazur, Marta; Corridore, Denise; Pasqualotto, Debora; Nardi, Gianna Maria; Ottolenghi, Livia

    2015-01-01

    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. PMID:25874260

  17. Safety Evaluation of CNS Administered Biologics-Study Design, Data Interpretation, and Translation to the Clinic.

    PubMed

    Vuillemenot, Brian R; Korte, Sven; Wright, Teresa L; Adams, Eric L; Boyd, Robert B; Butt, Mark T

    2016-07-01

    Many central nervous system (CNS) diseases are inadequately treated by systemically administered therapies due to the blood brain barrier (BBB), which prevents achieving adequate drug concentrations at sites of action. Due to the increasing prevalence of neurodegenerative diseases and the inability of most systemically administered therapies to cross the BBB, direct CNS delivery will likely play an increasing role in treatment. Administration of large molecules, cells, viral vectors, oligonucleotides, and other novel therapies directly to the CNS via the subarachnoid space, ventricular system, or parenchyma overcomes this obstacle. Clinical experience with direct CNS administration of small molecule therapies suggests that this approach may be efficacious for the treatment of neurodegenerative disorders using biological therapies. Risks of administration into the brain tissue or cerebrospinal fluid include local damage from implantation of the delivery system and/or administration of the therapeutic and reactions affecting the CNS. Preclinical safety studies on CNS administered compounds must differentiate between the effects of the test article, the delivery device, and/or the vehicle, and assess exacerbations of reactions due to combinations of effects. Animal models characterized for safety assessment of CNS administered therapeutics have enabled human trials, but interpretation can be challenging. This manuscript outlines the challenges of preclinical intrathecal/intracerebroventricular/intraparenchymal studies, evaluation of results, considerations for special endpoints, and translation of preclinical findings to enable first-in-human trials. Recommendations will be made based on the authors' collective experience with conducting these studies to enable clinical development of CNS-administered biologics.

  18. Evaluation of mineral trioxide aggregate as root canal sealer: A clinical study

    PubMed Central

    Thakur, Sophia; Emil, Jonathan; Paulaian, Benin

    2013-01-01

    Aim: The aim of this study was to compare the clinical and radiological outcome of mineral trioxide aggregate (MTA) or epoxy resin as a root canal sealer compared with zinc oxide eugenol sealer. Materials and Methods: 45 single rooted teeth with periapical index Score 2 or more were allotted to three groups with 15 teeth in each group. Root canal treatment was performed in two visits and obturated with Gutta-percha as obturating material and zinc oxide eugenol as sealer in Group 1, epoxy resin as sealer in Group 2 and MTA mixed with propylene glycol as sealer in Group 3. Visual analog scale, periapical index and VixWin digital Pro image analysis software were used for evaluation. The quantitative data was analyzed by t-test and analysis of variance. Ordinal data was analyzed by Wilcoxon's signed rank test, Mann-Whitney and Kruskall-Wallis test. Results: Results suggested that there exists no statistically significant difference in clinical or radiological outcome of root canal therapy with three different types of sealers used in this study. Conclusions: MTA could be used as a root canal sealer with equal effectiveness compared with epoxy resin and zinc oxide eugenol sealers. Further long-term studies should be carried out to prove the effectiveness. PMID:24347880

  19. Evaluating a Novel Summary Visualization for Clinical Trial Reports: A Usability Study

    PubMed Central

    Tong, Maurine; Hsu, William; Taira, Ricky K.

    2016-01-01

    Contributions of clinical trials are captured in published reports that are unstructured and often require extensive manual review to gain a deeper understanding of the study itself. Our goal is to increase comprehension and decrease the time necessary to understand these reports through the use of visualization tools. In this paper, we specify and evaluate the visualization of a previously developed representation as well as gain insight from user input for further development. The usability experiment consisted of a two-arm study with users either having or not having access to the visualization. A user questionnaire was used to measure time spent and accuracy in comprehension; intuitiveness and reproducibility of the visualization; and preferences. We found that having the visualization required on average 28.1% less time (25.8 min vs. 35.8 min, p=0.01) while maintaining similar accuracy (73.7% vs. 67.0%). Users were then asked to create their own visualizations, with their visualizations averaging 86.1% similar to the gold standard. All participants either preferred the visualization over the status quo or preferred both equally. These results demonstrate that novel visualizations for trial reports could provide time savings and achieve similar accuracy as reviewing the paper itself. Understanding the strength and quality of clinical trials can be alleviated with a visualization that makes content explicit. PMID:28269960

  20. Non-stroke neurological syndromes associated with antiphospholipid antibodies: evaluation of clinical and experimental studies.

    PubMed

    Chapman, J; Rand, J H; Brey, R L; Levine, S R; Blatt, I; Khamashta, M A; Shoenfeld, Y

    2003-01-01

    Although many types of neurological disorders and events have been described in association with antiphospholipid antibodies (aPL) and the antiphospholipid syndrome (APS), only ischaemic stroke is reasonably well established and accepted as a diagnostic criterion for the syndrome. We propose to evaluate, classify and rank the association of other neurological manifestations as possible, probable, or definite according to the data available from clinical studies and animal models. By these criteria, none of the neurological disorders or events such as epilepsy, psychiatric disease, dementia, transverse myelitis, multiple sclerosis-like disease, chorea, migraine, Guillian-Barrè syndrome, and sensory-neural hearing loss, can be definitely associated with aPL or APS.

  1. Spectrophotometric color evaluation of permanent incisors, canines and molars. A cross-sectional clinical study

    PubMed Central

    POP-CIUTRILA, IOANA-SOFIA; COLOSI, HORATIU ALEXANDRU; DUDEA, DIANA; BADEA, MANDRA EUGENIA

    2015-01-01

    Background and aims An accurate color reproduction represents the final validation level of an esthetic anterior or posterior restoration. The aim of this study was to evaluate the color of permanent maxillary incisors, canines and molars, using a clinical spectrophotometer. Methods The Vita Easyshade Advance 4.0® intraoral spectrophotometer was used by one clinician to determine the color of 369 permanent maxillary incisors, canines and molars. The best matches to Vitapan Classical® and 3D-Master® shade guides were recorded. A one-way analysis of variance and Kruskal-Wallis test were used to compare L*, a*, b*, c* and h* color coordinates among the 3 types of teeth. Differences between the mean values of all color coordinates were evaluated by use of Bonferroni corrections. Color difference (ΔE*) between incisors, canines and molars was calculated from ΔL*, Δa* and Δb* data and the results were compared to ΔE*=3.3 acceptability threshold. Results Except for Δa* and Δh* between canines and molars, statistically significant differences among the mean differences of all color coordinates were found when the 3 types of teeth were compared by pairs. The most frequently measured shades were A1 (48.4%), respectively 1M1 (31.5%) for incisors, B3 (36.6%), respectively 2M3 (39.8%) for canines and B3 (44.7%), respectively 2M3 (52%) for molars. Incisors had the highest lightness values, followed by canines and molars. Molars were the most chromatic with the highest a* and b* values. Conclusions Despite the limitations of this study, color differences among incisors, canines and molars were found to be statistically significant, above the clinical acceptability threshold established. In conclusion, successful esthetic restorations of permanent teeth of the same patient need an individual color assessment and reproduction of every type of tooth. PMID:26733753

  2. Binostril versus mononostril approaches in endoscopic transsphenoidal pituitary surgery: clinical evaluation and cadaver study.

    PubMed

    Conrad, Jens; Ayyad, Ali; Wüster, Christian; Omran, Wael; Weber, Matthias M; Konerding, Moritz A; Müller-Forell, Wibke; Giese, Alf; Oertel, Joachim

    2016-08-01

    OBJECTIVE Over the past 2 decades, endoscopy has become an integral part of the surgical repertoire for skull base procedures. The present clinical evaluation and cadaver study compare binostril and mononostril endoscopic transnasal approaches and the surgical techniques involved. METHODS Forty patients with pituitary adenomas were treated with either binostril or mononostril endoscopic surgery. Neurosurgical, endocrinological, ophthalmological, and neuroradiological examinations were performed. Ten cadaver specimens were prepared, and surgical aspects of the preparation and neuroradiological examination were documented. RESULTS In the clinical evaluation, 0° optics were optimal in the nasal and sphenoidal phase of surgery for both techniques. For detection of tumor remnants, 30° optics were superior. The binostril approach was significantly more time consuming than the mononostril technique. The nasal retractor limited maneuverability of instruments during mononostril approaches in 5 of 20 patients. Endocrinological pituitary function, control of excessive hormone secretion, ophthalmological outcome, residual tumor, and rates of adverse events, such as CSF leaks and diabetes insipidus, were similar in both groups. In the cadaver study, there was no significant difference in the time required for dissection via the binostril or mononostril technique. The panoramic view was superior in the binostril group; this was due to the possibility of wider opening of the sella in the craniocaudal and horizontal directions, but the need for removal of more of the nasal septum was disadvantageous. CONCLUSIONS Because of maneuverability of instruments and a wider view in the sphenoid sinus, the binostril technique is superior for resection of large tumors with parasellar and suprasellar expansion and tumors requiring extended approaches. The mononostril technique is preferable for tumors with limited extension in the intra- and suprasellar area.

  3. Evaluation of Hi-Tec Implant Restoration in Mandibular First Molar Region- A Prospective Clinical Study

    PubMed Central

    Sreeram, Roopa Rani. S.; Prasad, L Krishna; Chakravarthi, P Srinivas; Devi, Naga Neelima; Sreeram, Sanjay Krishna

    2015-01-01

    Background and Aims Missing teeth lead to loss of structural balance, inefficient function, poor aesthetics and psychological effects on human beings, which needs restoration for normal contour, function and aesthetics. Several natural or synthetic substitutes are being used for replacement of missing tooth since centuries. Implants are the latest modality of replacement. So, the study was aimed to assess clinical success rate of Hi-Tec implant; which is economical and new in market. Results of the study will help clinician for appropriate implant selection. Materials and Methods The study included 10 patients from 19 to 31 years and needed restoration of missing mandibular first molar. Restoration had done using Hi Tec Single-tooth implants with metal-ceramic single crown prosthesis after three months of osseointegration. The implants were evaluated clinically (bleeding on probing, probing depth, implant mobility- periotest) and radiographically (marginal bone loss and peri-implant radiolucency) for six years. The observers were blinded for the duration of the study to prevent bias. Results All the patients had uneventful post-surgical healing. No bleeding on probing, Implant mobility, peri-implant radiolucency with minimal marginal bone loss and constant probing depths were observed well within the normal range during follow-up periods. Conclusion Two stage single-tooth Hi Tec implant restoration can be used as a successful treatment modality for replacing mandibular first molar in an economic way. However, these results were obtained after 6 years of follow up with a smaller sample size, so long term multi center studies with a larger sample size is recommended for the predictability of success rate conclusively. PMID:26436053

  4. Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

    PubMed

    Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

    2016-07-01

    A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information.

  5. Evaluation of incidence rates in pre-clinical studies using a Williams-type procedure.

    PubMed

    Hothorn, Ludwig A; Sill, Martin; Schaarschmidt, Frank

    2010-01-01

    The analysis of dose-response relationships is a common problem in pre-clinical studies. For example, proportions such as mortality rates and histopathological findings are of particular interest in repeated toxicity studies. Commonly applied designs consist of an untreated control group and several, possibly unequally spaced, dosage groups. The Williams test can be formulated as a multiple contrast test and is a powerful option to evaluate such data. In this paper, we consider simultaneous inference for Williams-type multiple contrasts when the response variable is binomial and sample sizes are only moderate. Approximate simultaneous confidence limits can be constructed using the quantiles of a multivariate normal distribution taking the correlation into account. Alternatively, multiplicity-adjusted p-values can be calculated as well. A simulation study shows that a simple correction based on adding pseudo observations leads to acceptable performance for moderate sample sizes, such as 40 per group. In addition, the calculation of adjusted p-values and approximate power is presented. Finally, the proposed methods are applied to example data from two toxicological studies; the methods are available in an R-package.

  6. Clinical studies with disposable diapers containing absorbent gelling materials: evaluation of effects on infant skin condition.

    PubMed

    Campbell, R L; Seymour, J L; Stone, L C; Milligan, M C

    1987-12-01

    Disposable infant diapers with absorbent gelling material (cross-linked sodium polyacrylates) incorporated into the core were clinically evaluated for their effect on infant skin condition. Absorbent gelling materials tightly hold water and provide pH control by a buffering capacity as well as by helping to segregate urine apart from feces. Four clinical studies were conducted with each following a rigid protocol that controlled for variables of diet and age in addition to the diaper material that may influence the development of diaper dermatitis and helped to control for any inherent bias in the study. This allowed for the controlled assessment of skin condition with respect to diaper type. Absorbent gelling material-containing disposable, conventional (100% cellulose core) disposable, and home-laundered cloth diapers were test products. In these studies 1614 infants were initially enrolled with 522 of them assigned to absorbent gelling material disposable, 738 to conventional disposable, and 354 to home-laundered cloth diapers. Objective measurements of skin wetness (transepidermal water loss) and skin pH, as well as double-blind grading of diaper dermatitis, were the measures of skin condition. Absorbent gelling material disposable diapers were associated with significantly reduced skin wetness, closer to normal skin pH, and lower degrees of diaper dermatitis when compared to conventional disposable or home-laundered cloth diapers. The results are consistent with the hypothesis that better control in the diaper area of skin wetness, skin pH, and the prevention of the mixing of urine and feces produces a better diaper environment.

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

    PubMed Central

    2012-01-01

    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. PMID:23259846

  8. Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

    PubMed Central

    Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

    2009-01-01

    Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

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

    PubMed

    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.

  10. [Key Points for Design and Evaluation of Clinical Studies in Treating Children's Attention Deficit Hyperactivity Disorder by Chinese Medical New Drugs].

    PubMed

    Shen, Wen; Ma, Rong; Hu, Si-yuan

    2015-05-01

    Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.

  11. [New strategies in the clinical evaluation of patients with colon cancer based on molecular studies].

    PubMed

    Panduro, A; Morales, L; Santos, A; Valdés, L; Lima, G; Meléndez, J; Cabrera, G; Maldonado, V; Villalobos, J J

    1993-01-01

    During the last five years molecular studies allowed important advances in the knowledge of cancer colon with important clinical implications. The main finding was the identification and sequence analysis of the APC gen. Structural alterations of this gene have been detected in patients with Familial Adenomatous Polyposis and Gardner syndrome, which suggest a common disease. Furthermore, alterations of the APC gen appears to be also altered in cases of cancer of colon sporadic. Indicating that structural alteration of the APC gen can be inherited and/or acquired. Restriction fragment-length polymorphisms in the chromosome 5q21-22 can now be used clinically for premorbid diagnosis and counseling in familial adenomatous polyposis. The molecular studies allow the clinician to have a new approach in the management and screening of families with familial adenomatous polyposis. The sequence analysis and specific identification of the structural alteration of the APC gene is a more expensive and sophisticated study, although represent a more direct approach. In the Department of Gastroenterology of the INNSZ we are performing such molecular studies. The main purpose of our group is to proportionate integral clinical-molecular studies for families with hereditary colon cancer, create a national register of these diseases and investigate the molecular bases in order to generate new molecular diagnosis tools.

  12. Evaluation of factors predicting clinical pleural injury during percutaneous nephrolithotomy: a prospective study.

    PubMed

    Sharma, Kuldeep; Sankhwar, Satya Narayan; Singh, Vishwajeet; Singh, Bhupendra Pal; Dalela, Diwakar; Sinha, Rahul Janak; Kumar, Manoj; Singh, Manmeet; Goel, Apul

    2016-06-01

    The purpose of this study is to prospectively identify factors that predict the chance of pleural injury (detected clinically or on postoperative X-ray chest) during percutaneous nephrolithotomy (PCNL). All patients with renal/upper ureteric stones, undergoing PCNL between January 2013 and June 2014, were evaluated for pleural injury. An erect chest X-ray on inspiration was done within 6 h of PCNL. The patients were divided into Groups A and B depending on whether they developed or did not develop pleural injury. Patient-, stone-, renal-, and procedure-related factors were compared between the two groups. 332 patients with mean age 36.76 ± 15.01 years (range 4-80) and M:F of 172:160 fulfilled the inclusion criteria. Pleural complications occurred in 10 patients (3 %). Of 141 patients with supracostal punctures (59 had additional infracostal punctures), 4.2 % (n = 6) had pleural injury. Of 191 patients with only infracostal punctures, 4 developed pleural injuries (2 %). Patients in group A had significantly lower age (27.00 ± 11.18 vs. 37.06 ± 15.03, p = 0.03) and lower BMI (18.0 ± 1.90 vs. 21.12 ± 2.24 p = 0.002). Incidence of pleural injury was significantly higher (p = 0.001) on right side [4.0 % (7/172) vs. 1.8 %, 3/160)]. Incidence of pleural injury had no association with staghorn calculi, stone surface area (590.51 ± 313.88 for Group A vs. 593.02 ± 387.10 for Group B; p = 0.11), degree of hydronephrosis, and operative time (65.13 ± 19.45 for Group A vs. 72.21 ± 19.56 for Group B; p = 0.06). On multivariate analysis, only low BMI and mean age <27 years were associated with higher risk of pleural injury. Higher incidence of pleural injury was noted in patients with low BMI and younger age.

  13. Clinical evaluation of the centrifugal pump in open heart surgery: a comparative study of different pumps.

    PubMed

    Takarabe, K; Yoshikai, M; Murayama, J; Hamada, M; Ito, T

    1997-07-01

    The centrifugal pump is now widely used in open heart surgery for its clinical benefits related to the blood elements and the coagulation system. The purpose of this study was to compare the clinical performances of and the outcomes offered by 4 types of centrifugal pumps. For each pump, we investigated the effects on the blood elements, coagulation system, complements, and immunoglobulins during open heart surgery. Four types of centrifugal pumps were used: the HPM-15 (Nikkiso Co.), the Capiox (Terumo Co.), the Lifestream (St. Jude Medical Co.), and the BP-80 (Medtronic, BioMedicus Co.). The platelet count, lactate dehydrogenase (LDH), antithrombin III (AT III), thrombin-antithrombin complex (TAT), complements (C3, C4, and CH50), and immunoglobulins (IgG, IgA, and IgM) were measured before and after cardiopulmonary bypass (CPB). The platelet count was decreased more significantly by the HPM-15 than by any of the other pumps. The other parameters showed no difference among the 4 pumps. In clinical use, each of the 4 types of centrifugal pumps was safe.

  14. The virtual clinical evaluation tool.

    PubMed

    Sander, Rebecca; Trible, Karen A

    2008-01-01

    Two years ago, faculty and students at this rural university setting collaborated to implement a virtual clinical evaluation tool. In recognition of the frustrations involved in coordinating instructor and student input to a hard copy tool, a virtual clinical evaluation tool was created in the form of an Excel spreadsheet. Excel documents have the advantage of immediate retrieval and use by instructors or students, ease of narration by word processing, automatic mathematical computation of formative and summative scores, and data storage through computer archives. Using the online Blackboard course, students and instructors are able to collaboratively input a Likert score for each posted evaluation outcome and word process-related comments about students' clinical performance. An overview of the 2-year implementation of this virtual clinical evaluation tool, as well as the evaluation process, is discussed.

  15. Clinical evaluation of moxalactam.

    PubMed Central

    Mathisen, G E; Meyer, R D; Thompson, J M; Finegold, S M

    1982-01-01

    Moxalactam was administered intravenously or intramuscularly or both in doses of 1 to 12 g/day to 45 patients with clinically significant infections (17 soft tissue or bone, 9 pleuropulmonary, 9 septicemic, 6 urinary tract, and 4 intraabdominal infections). Mean 0.5-h postinfusion levels were 105 micrograms/ml for a 4.0-g dose, 44.7 micrograms/ml for a 2.0-g dose, and 18 micrograms/ml for a 1.0-g dose. We identified 28 isolates of Enterobacteriaceae, 10 Pseudomonas aeruginosa isolates, 9 Staphylococcus aureus isolates, and 15 anaerobic bacterial isolates. A total of 15 patients were clinically cured, 8 patients improved, 13 patients improved initially but suffered subsequent relapses or superinfections, and 10 patients failed therapy. Toxicity was generally minimal (reversible eosinophilia, and mild liver function abnormalities, and elevated prothrombin time). The selection or emergence of resistant organisms in 17 patients during treatment (particularly Pseudomonas, enterococci, and Candida) was a disturbing feature of therapy. Our results were generally favorable, considering the complicated underlying medical problems of this group of patients. PMID:6213198

  16. USE OF THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE (MCID) FOR EVALUATING TREATMENT OUTCOMES WITH TMJMD PATIENTS: A PRELIMINARY STUDY1

    PubMed Central

    Ingram, Megan; Choi, Yun Hee; Chiu, Chung-Yi; Haggard, Rob; Dougall, Angela Liegey; Buschang, Peter; Gatchel, Robert J.

    2012-01-01

    Temporomandibular joint and muscle disorder (TMJMD) is one of the most prevalent types of musculoskeletal disorders. The major goal of the study was to more objectively quantify clinically meaningful relief for TMJMD treatment outcomes by using the new metric of minimal clinically important difference (MCID). Pre- to post-treatment changes on a number of self-report measures were evaluated in a cohort of 101 acute TMJMD patients. An anchor-based MCID approach was employed, with an objective chewing performance measure serving as the clinical outcome of interest. Using a Receiver Operating Curve analysis, it was found that the Physical Component Scale (PCS) of the SF-36 was the most robust self-report measure to use as the MCID in a TMJMD patient population. PMID:22919263

  17. Biograft-HT® as a bone graft material in the treatment of periodontal vertical defects and its clinical and radiological evaluation: Clinical study

    PubMed Central

    Chandrashekar, K. T.; Saxena, Chhavi

    2009-01-01

    Aim: To determine the efficacy of Biograft-HT® as a bone graft material in the treatment of vertical defects in generalized chronic periodontitis patients and their clinical and radiological evaluation. Patients and Methods: Twenty patients diagnosed with generalized chronic periodontitis having two or more vertical defects were selected for this study. Clinical parameters like plaque index, gingival index, probing pocket depth and clinical attachment levels were recorded at different points of time over six months. Radiographic evaluation included the depth of the bone defect and the percentage of bone defect fill and was carried out for both the groups at baseline, three months and six months. After recording clinical parameters and administering phase-1 therapy, the sites were randomly treated either with Biograft- HT® or open flap debridement only. Results: At the end of six months there was a significant reduction in the plaque and gingival scores in both test and control groups. There was 64% decrease in probing pocket depth for the test site as compared to 54.52% decrease seen for the control group. Similarly there was an 84.82% gain in clinical attachment level from the baseline to six months post operatively for the experimental group in comparison to 68.83% gain for the control group. Furthermore, 43.57% bone fill was observed for the experimental site whereas only 17.98% of bone fill was evident in the control site. Conclusion: Biograft –HT improves healing outcomes, leads to a reduction of probing depth, a resolution of osseous defects and a gain in clinical attachment, compared with open flap debridement by itself. PMID:20379411

  18. The evaluation of chorionic membrane in guided tissue regeneration for periodontal pocket therapy: a clinical and radiographic study.

    PubMed

    Kothiwale, Shaila V

    2014-03-01

    Periodontal regenerative therapy is aimed at reconstruction and to restore the architecture and function of lost or injured tissues. Melcher (J Periodontol 47(5):256-260, 1976) introduced the concept of guided tissue regeneration (GTR) for osseous reconstructive surgery. The aim of the present innovative clinical and radiographic study was to evaluate the effect of chorionic membrane (CM) in GTR in periodontal pocket therapy. Ten patients with moderate to severe periodontitis were selected in the single blind randomized controlled clinical trial. Patients were treated with periodontal pocket therapy along with CM in study sites and the control sites were treated with periodontal pocket therapy alone. The clinical parameters were recorded at baseline and 12 months. The radiographic parameters were recorded at baseline, 6 and 12 months. Clinical parameters included gingival index (GI), plaque index (PI), pocket probing depth (PPD) and relative attachment level (RAL). Digital images were analysed for bone gain (BG) and density. Data were evaluated using t test. Statistical significant differences were found in both sites at 12 months for GI, PI, PPD and RAL. Highly significant reduction was seen in GI 0.40 ± 0.08 (p = 0.0001), PI (0.41 ± 0.18), PPD 2.50 ± 0.53 mm (p = 0.0431) and increased BG 0.86 ± 0.18 (p < 0.0001) were observed in study sites. This shows that CM when used with pocket therapy can have influence on clinical parameters. Radiographic findings from this study demonstrated significant BG and density in sites treated with CM as compared to control sites.

  19. Clinical study to evaluate the effect of Virechanakarma on serum electrolytes

    PubMed Central

    Rais, Adil; Bhatted, Santoshkumar

    2013-01-01

    Panchakarma therapy aims at the elimination of excessive Doshas from the body to maintain the state of health for a longer duration, while the Shamana therapy is for suppression of vitiated Doshas within the body. Virechana is one of the Panchakarma therapies wherein purgation is induced by drugs and it specifically aims at the elimination of excessive Pitta Dosha from the body. Normally, after Virechanakarma, patient does not complain of having any untoward like those present after diarrhea due to dehydration. This study was conducted to evaluate the effect of Virechanakarma on serum electrolyte levels and to ascertain the safety of therapeutic purgation. This study involved estimation of serum electrolyte levels before and after Virechana in 15 patients and the results are suggestive of safe application of the Virechana therapy as the deviation in electrolyte levels were within the normal range. PMID:24696575

  20. Portable handheld diffuse reflectance spectroscopy system for clinical evaluation of skin: a pilot study in psoriasis patients.

    PubMed

    Tzeng, Shih-Yu; Guo, Jean-Yan; Yang, Chao-Chun; Hsu, Chao-Kai; Huang, Hung Ji; Chou, Shih-Jie; Hwang, Chi-Hung; Tseng, Sheng-Hao

    2016-02-01

    Diffuse reflectance spectroscopy (DRS) has been utilized to study biological tissues for a variety of applications. However, many DRS systems are not designed for handheld use and/or relatively expensive which limit the extensive clinical use of this technique. In this paper, we report a handheld, low-cost DRS system consisting of a light source, optical switch, and a spectrometer, that can precisely quantify the optical properties of tissue samples in the clinical setting. The handheld DRS system was employed to determine the skin chromophore concentrations, absorption and scattering properties of 11 patients with psoriasis. The measurement results were compared to the clinical severity of psoriasis as evaluated by dermatologist using PASI (Psoriasis Area and Severity Index) scores. Our statistical analyses indicated that the handheld DRS system could be a useful non-invasive tool for objective evaluation of the severity of psoriasis. It is expected that the handheld system can be used for the objective evaluation and monitoring of various skin diseases such as keloid and psoriasis.

  1. Portable handheld diffuse reflectance spectroscopy system for clinical evaluation of skin: a pilot study in psoriasis patients

    PubMed Central

    Tzeng, Shih-Yu; Guo, Jean-Yan; Yang, Chao-Chun; Hsu, Chao-Kai; Huang, Hung Ji; Chou, Shih-Jie; Hwang, Chi-Hung; Tseng, Sheng-Hao

    2016-01-01

    Diffuse reflectance spectroscopy (DRS) has been utilized to study biological tissues for a variety of applications. However, many DRS systems are not designed for handheld use and/or relatively expensive which limit the extensive clinical use of this technique. In this paper, we report a handheld, low-cost DRS system consisting of a light source, optical switch, and a spectrometer, that can precisely quantify the optical properties of tissue samples in the clinical setting. The handheld DRS system was employed to determine the skin chromophore concentrations, absorption and scattering properties of 11 patients with psoriasis. The measurement results were compared to the clinical severity of psoriasis as evaluated by dermatologist using PASI (Psoriasis Area and Severity Index) scores. Our statistical analyses indicated that the handheld DRS system could be a useful non-invasive tool for objective evaluation of the severity of psoriasis. It is expected that the handheld system can be used for the objective evaluation and monitoring of various skin diseases such as keloid and psoriasis. PMID:26977366

  2. Gow-Gates Technique: A Pilot Study for Extraction Procedures With Clinical Evaluation and Review

    PubMed Central

    Kohler, Bernhard Rolf; Castellón, Loreto; Laissle, Germán

    2008-01-01

    The aim of this study was to compare the effectiveness of 2 different volumes of anesthetic solution for a premolar-molar extraction, and to determine the onset of complete mandibular conduction anesthesia via a Gow-Gates mandibular block. One operator performed 32 blocks with a 27-gauge needle on patients who required a dental extraction: 16 blocks using 1.8 mL of anesthetic solution, and 16 blocks using 3.6 mL of anesthetic solution. The parameters evaluated were frequency of successful anesthesia and onset of complete anesthesia. Significant differences (P < .005) were observed in the evaluation of volume: the 3.6 mL group yielded a higher success rate (82.5%) than the 1.8 mL group (17.5%). The onset of complete conduction anesthesia was achieved in 8 minutes by 56% of the subjects (9 of 16) with 3.6 mL and only one subject in 16 (6%) with 1.8 mL. A larger volume of anesthetic solution (3.6 mL) is required to achieve a higher success rate and a faster onset of action for a dental extraction without the use of reinforcement anesthesia. The volume of anesthetic solution is indirectly proportional to the onset of complete anesthesia. A premolar-molar extraction can be done, with 3.6 mL of anesthetic solution, in more than 50% of the patients 8 minutes after injection. PMID:18327969

  3. Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology

    PubMed Central

    Ryan, Michael C.; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C.; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R.V. Paul; Chiang, Michael F.

    2014-01-01

    Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis. PMID:25954463

  4. Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology.

    PubMed

    Ryan, Michael C; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R V Paul; Chiang, Michael F

    2014-01-01

    Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis.

  5. Evaluation of the role of antibiotics in preventing postoperative complication after routine periodontal surgery: A comparative clinical study

    PubMed Central

    Mohan, Rosh Radhika; Doraswamy, Dwarakanath Chinni; Hussain, Ahad M.; Gundannavar, Gayatri; Subbaiah, Shobha Krishna; Jayaprakash, Deepika

    2014-01-01

    Background and Objectives: Aim of this randomly controlled clinical study was to evaluate the role of antibiotics to prevent postoperative complications after routine periodontal surgery and also to determine whether their administration improved the surgical outcome. Materials and Methods: Forty-five systemically healthy patients with moderate to severe chronic periodontitis requiring flap surgery were enrolled in the study. They were randomly allocated to Amoxicillin, Doxycycline, and control groups. Surgical procedures were carried out with complete asepsis as per the protocol. Postoperative assessment of patient variables like swelling, pain, temperature, infection, ulceration, necrosis, and trismus was performed at intervals of 24 h, 48 h, 1 week, and 3 months. Changes in clinical parameters such as gingival index, plaque index, probing pocket depth, and clinical attachment level were also recorded. Results: There was no incidence of postoperative infection in any of the patients. Patient variables were comparable in all the three groups. Though there was significant improvement in the periodontal parameters in all the groups, no statistically significant result was observed for any group over the others. Conclusion: Results of this study showed that when periodontal surgical procedures were performed following strict asepsis, the incidence of clinical infection was not significant among all the three groups, and also that antibiotic administration did not influence the outcome of surgery. Therefore, prophylactic antibiotics for patients who are otherwise healthy administered following routine periodontal surgery to prevent postoperative infection are unnecessary and have no demonstrable additional benefits. PMID:24872630

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

    PubMed Central

    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) using paired t-test (at 95% confidence interval). Bennett angle values of the right and left sides found using the Hanau's formula were almost similar. Difference in the Bennett angle values of the right and left sides were found using the jaw tracking device. However, this difference was not statistically significant (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

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

    PubMed Central

    Grover, Harpreet Singh; Dadlani, Himanshu; Bhardwaj, Amit; Yadav, Anil; Lal, Sanjay

    2014-01-01

    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. PMID:25425820

  8. Evaluation of a bioresorbable collagen membrane of fish origin in the treatment of periodontal intrabony defects: A prospective clinical study

    PubMed Central

    Santosh Kumar, B.B.; Aruna, D.R.; Gowda, S. Vinayak; Galagali, R. Sushama

    2013-01-01

    Background: Recently, there has been interest in non-mammalian collagen sources such as fish collagen in the development of biomatrices and scaffolds for periodontal regeneration. In the present study, a novel collagen barrier membrane of fish origin was assessed in the treatment of periodontal intra-bony defects. Materials and Methods: Ten systemically healthy chronic periodontitis patients having an osseous defect in the mandibular posterior teeth were selected and following the open flap debridement, a collagen membrane was placed over the defect and the flap was sutured with interrupted sutures. Clinical parameters such as Plaque Index, Gingival Bleeding Index, probing pocket depth (PPD), relative attachment level (RAL), and recession (R) were recorded at baseline, 6 and 9 months, whereas radiographic evaluation was done to assess alveolar crestal bone level and defect depth fill at 6 and 9 months using Auto-computer aided design (ACAD) 2007 software. Statistical significance was set at 5% level of significance. Results: There was statistical significant differences with respect to periodontal clinical parameters such as Plaque Index, Gingival Bleeding Index, PPD, RAL, and gingival recession assessed at baseline, at 6 and 9 months respectively (P < 0.05), and radiographic evaluation showed a defect fill of 58.62 median % at 9 months. Conclusion: This preliminary study has shown predictable results in using fish collagen membrane, for treating periodontal intra-bony defects. Further, long-term clinical trials are needed to validate the effectiveness of this membrane. PMID:23946741

  9. Studies on the traditional herbal anthelmintic Chenopodium ambrosioides L.: ethnopharmacological evaluation and clinical field trials.

    PubMed

    Kliks, M M

    1985-01-01

    Infusions and decoctions of the leaves, roots and inflorescences of the herbaceous shrub Chenopodium ambrosioides (American wormseed, goosefoot, epazote, paico) and related species indigenous to the New World have been used for centuries as dietary condiments and as traditional anthelmintics by native peoples for the treatment of intestinal worms. Commercial preparations of oil of chenopodium and its active constituent, ascaridol, obtained by steam distillation, have been and continue to be, used with considerable success in mass treatment campaigns. Ethnopharmacological studies in a community of Mayan subsistence farmers in Chiapas, Mexico, confirmed that decoctions containing up to 300 mg of dry plant material per kg body weight (MGKGW) were widely used and traditionally highly regarded in the treatment of ascariasis. However, therapeutic doses of up to 6000 MGKGW of powdered, dried plant had no significant anthelmintic effect on the adults of Necator, Trichuris of Ascaris. Gas-liquid chromatographic analyses of plant samples used consistently demonstrated the presence of ascaridol in the expected amounts. Possible origins of subjective belief in the efficacy of C. ambrosioides as used, may be related to the positive association of spontaneous, or peristalsis-induced passage of senescent worms immediately following a therapeutic episode. It is also possible that in the past varieties of the plant containing much more ascaridol were used. The results of these controlled field studies did not sustain widely held traditional beliefs, nor the value of therapeutic practices regarding this plant. It is, therefore, essential that all indigenous ethnomedical practices be objectively evaluated for efficacy and safety using appropriate protocols before being considered for adoptation or promotion in health care programs.(ABSTRACT TRUNCATED AT 250 WORDS)

  10. Lymph node evaluation for colon cancer in routine clinical practice: a population-based study

    PubMed Central

    Del Paggio, J.C.; Nanji, S.; Wei, X.; MacDonald, P.H.; Booth, C.M.

    2017-01-01

    Background Guidelines recommend that 12 or more lymph nodes (lns) be evaluated during surgical resection of colon cancer. Here, we report ln yield and its association with survival in routine practice. Methods Electronic records of treatment were linked to the population-based Ontario Cancer Registry to identify all patients with colon cancer treated during 2002–2008. The study population (n = 5508) included a 25% random sample of patients with stage ii or iii disease. Modified Poisson regression was used to identify factors associated with ln yield; Cox models were used to explore the association between ln yield and overall (os) and cancer-specific survival (css). Results During 2002–2008, median ln yield increased to 17 from 11 nodes (p < 0.001), and the proportion of patients with 12 or more nodes evaluated increased to 86% from 45% (p < 0.001). Lymph node positivity did not change over time (to 53% from 54%, p = 0.357). Greater ln yield was associated with younger age (p < 0.001), less comorbidity (p = 0.004), higher socioeconomic status (p = 0.001), right-sided tumours (p < 0.001), and higher hospital volume (p < 0.001). In adjusted analyses, a ln yield of less than 12 nodes was associated with inferior os and css for stages ii and iii disease [stage ii os hazard ratio (hr): 1.36; 95% confidence interval (ci): 1.19 to 1.56; stage ii css hr: 1.52; 95% ci: 1.26 to 1.83; and stage iii os hr: 1.45; 95% ci: 1.30 to 1.61; stage iii css hr: 1.54; 95% ci: 1.36 to 1.75]. Conclusions Despite a temporal increase in ln yield, the proportion of cases with ln positivity has not changed. Lymph node yield is associated with survival in patients with stages ii and iii colon cancer. The association between ln yield and survival is unlikely to be a result of stage migration. PMID:28270730

  11. 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)

    PubMed Central

    Harris, Stewart B.; Naqshbandi Hayward, Mariam; Tompkins, Jordan W.

    2016-01-01

    Abstract Rationale, aims and objectives 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. Method 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. Results 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. Conclusions 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. PMID:26804339

  12. Evaluation of the efficiency of biofield diagnostic system in breast cancer detection using clinical study results and classifiers.

    PubMed

    Subbhuraam, Vinitha Sree; Ng, E Y K; Kaw, G; Acharya U, Rajendra; Chong, B K

    2012-02-01

    The division of breast cancer cells results in regions of electrical depolarisation within the breast. These regions extend to the skin surface from where diagnostic information can be obtained through measurements of the skin surface electropotentials using sensors. This technique is used by the Biofield Diagnostic System (BDS) to detect the presence of malignancy. This paper evaluates the efficiency of BDS in breast cancer detection and also evaluates the use of classifiers for improving the accuracy of BDS. 182 women scheduled for either mammography or ultrasound or both tests participated in the BDS clinical study conducted at Tan Tock Seng hospital, Singapore. Using the BDS index obtained from the BDS examination and the level of suspicion score obtained from mammography/ultrasound results, the final BDS result was deciphered. BDS demonstrated high values for sensitivity (96.23%), specificity (93.80%), and accuracy (94.51%). Also, we have studied the performance of five supervised learning based classifiers (back propagation network, probabilistic neural network, linear discriminant analysis, support vector machines, and a fuzzy classifier), by feeding selected features from the collected dataset. The clinical study results show that BDS can help physicians to differentiate benign and malignant breast lesions, and thereby, aid in making better biopsy recommendations.

  13. Evaluation of continuous arch and segmented arch leveling techniques in adult patients--a clinical study.

    PubMed

    Weiland, F J; Bantleon, H P; Droschl, H

    1996-12-01

    The purpose of this study was to compare the efficacy of overbite correction achieved by a conventional continuous arch wire technique and the segmented arch technique as recommended by Burstone. The sample comprised 50 adult patients (age 18 to 40 years) with deep bites. Twenty-five patients were treated with a continuous arch wire technique (CAW); in the second half of the sample, the segmented arch technique (Burstone) was used for correction of the vertical malocclusion. Lateral cephalograms and plaster cast models taken before and immediately after treatment were evaluated. Statistical analysis was performed on the collected data. The results showed that both techniques produced a highly significant overbite reduction (CAW: -3.17 mm, p < 0.001; Burstone: -3.56 mm, p < 0.001). The CAW group showed an extrusion in the molar area with subsequent posterior rotation of the mandible (6occl-ML: +1.30 mm; 6occl-NSL: +1.63 mm; ML/NSL: +1.94 degrees, all p < 0.001). The Burstone group, however, showed overbite reduction by incisor intrusion without any substantial extrusion of posterior teeth (upper 1-NSL: -1.50 mm; lower 1-ML: -1.72 mm; both p < 0.001). As a consequence, no significant posterior rotation of the mandible took place (ML/NSL: +0.52 degrees, n.s.). It is concluded that in adult patients the segmented arch technique (Burstone) can be considered as being superior to a conventional continuous arch wire technique if arch leveling by incisor intrusion is indicated.

  14. Importance of yawning in the evaluation of excessive daytime sleepiness: a prospective clinical study.

    PubMed

    Catli, Tolgahan; Acar, Mustafa; Hanci, Deniz; Arikan, Osman Kursat; Cingi, Cemal

    2015-12-01

    As a dark and not fully understood side of human nature, yawning is believed to be a signs of various physiological or pathological behaviors of human. In this study, we aimed to investigate the importance of yawning in the evaluation of sleepiness. One hundred and twenty-nine snorers who were suspected to have obstructive sleep apnea syndrome underwent polysomnography and were asked to fill the Epworth sleepiness scale. The number of yawnings of patients was counted during the day following polysomnography. Patients were stratified into two groups: those have apnea hypopnea index <5 (n = 43, group 1) and those have apnea hypopnea index >30 (n = 86, group 2). Mean duration of sleep phases, oxygen saturations, sleep efficacies, yawning frequencies and Epworth scores of the groups were compared. Correlations of yawning frequency with Epworth scores, duration of sleep phases and mean oxygen saturations were investigated. Sleep efficacies were similar between the groups (p > 0.05). Yawning frequencies in group 1 and group 2 were 43.48 and 75.76 (mean rank), respectively (p < 0.01). Mean N1, N2, N3 phase durations and oxygen saturations were significantly lower in group 2 (p < 0.01). While there was a negative correlation between yawning frequency and duration of the non-REM phases and mean oxygen saturation (r = -0.53 and r = -0.31, respectively, p < 0.05), yawning frequency was positively correlated with Epworth scores (r = 0.46, p < 0.05). In addition to the shortened phases of sleep, increased Epworth score and decreased oxygen saturation, increased yawning frequency may indicate sleep deprivation.

  15. Asian diabetics attending a British hospital clinic: a pilot study to evaluate their care.

    PubMed Central

    Hawthorne, K

    1990-01-01

    A questionnaire survey of 40 Asian and 31 British non-insulin dependent diabetics attending a hospital clinic showed that both groups remembered receiving education about diabetes (90%) but Asian diabetics knew less about glucose monitoring and diabetic complications. Asians also had a more negative attitude towards the clinic, feeling they were made to wait longer than the British. They were frustrated by a lack of communication with the staff. Forty per cent of both Asian and British diabetics felt that diabetes prevented them from leading a normal lifestyle. Twenty seven per cent of both Asian and British diabetics used herbal or alternative medicines, but Asians differed in that they used these medicines specifically for diabetes. A further sample of 50 Asians had poorer glycaemic control than a sample of British diabetics matched for age, sex and type of diabetes. It is concluded that despite receiving the same education as British diabetics, Asians did not understand it as well. The education was often not relevant to their diets or customs. This may contribute to their poorer glycaemic control. Diabetic clinic facilities need to be improved for Asian diabetics, to improve their understanding of diabetes. PMID:2117948

  16. A Prospective Study of the Clinical Profile, Outcome and Evaluation of D-dimer in Cerebral Venous Thrombosis

    PubMed Central

    Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali

    2016-01-01

    Introduction Cerebral Venous Thrombosis (CVT) is a well known disease with diverse clinical presentation and causes. With advances in neuroimaging and changing lifestyles, the clinical profile and causes of CVT are changing. D-dimer has been studied in early diagnosis of CVT with variable results. This prospective study was carried out to assess the clinical profile of CVT and role of D-dimer in diagnosis of CVT. Aim To study various aspects of CVT and role of D-dimer. Materials and Methods The study period was September 2012 to July 2014 and included 80 imaging proven patients of CVT. We also included 39 controls for assessing D-dimer. Data was collected according to a preformed format. D-dimer was assessed by a rapid semi-quantitative latex agglutination assay. Discharged patients were followed up to six months. Results Of the total 44 were women and 36 were men (F: M=1.2:1). The mean age of the patients was 29.5±9.68 years. Most common clinical features were headache 77 (96.25%), papilloedema (67.5%) and seizures 51 (63.75%). Pregnancy was the most common cause of CVT. Superior sagittal and transverse sinuses were the most common sinuses to be affected. The sensitivity and specificity of D-dimer for diagnosing CVT was 84.62% and 80% respectively. The risk factors for poor prognosis were altered sensorium, presence of sepsis, increased sinus involvement and deep sinus thrombosis. Conclusion CVT affects both sexes equally. Puerperium still contributes to majority of the cases. Iron deficiency anaemia needs to be evaluated as a contributing factor for incidence of CVT. D-dimer is not useful in puerperal female with CVT. Positive D-dimer will strengthen the suspicion of CVT in patients with acute headache followed by a neurological deficit. PMID:27504325

  17. ["I dreamed that I dreamed": some notes on the clinical evaluation of therapist interventions, exemplified by Deserno's case study (session 290)].

    PubMed

    Berns, U; Hemprich, L

    2001-01-01

    In No. 8, 48th year, August 1998, of the journal "Psychotherapie--Psychosomatik--Medizinische Psychologie" the tape recorder transcription of the 290th session of a long-term analysis was studied by three methods (BIP, Frames, ZBKT). The paper presented here was stimulated by this publication. From the author's viewpoint substantial clinical aspects of evaluation could be added by applying a clinical evaluation method developed by R. Langs and his corresponding concept of interpretation. Clinical vignettes exemplify the possibility to resolve pathological countertransference by using this evaluation method. With the help of this method the presented transcription of the 290th session is evaluated partially.

  18. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study

    PubMed Central

    Bhatt, Manohar; Purohit, Kanchan; Acharya, Jitendra; Kumar, Rajesh; Garg, Rakesh

    2017-01-01

    Many plants with biological and antimicrobiological properties have been studied since there has been a relevant increase in the incidence of antibiotic overuse and misuse. In dentistry, phytomedicines have been used as anti-inflammatory, antibiotic, analgesic, and sedative agents. Turmeric is used extensively in foods for its flavor and color, as well as having a long tradition of use in the Chinese and Ayurvedic systems of medicine, particularly as an anti-inflammatory and for the treatment of flatulence, jaundice, menstrual difficulties, hematuria, hemorrhage, and colic. This article studies ahead with a new idea of using powdered turmeric as a material of pulpotomy procedure in primary teeth. How to cite this article Purohit RN, Bhatt M, Purohit K, Acharya J, Kumar R, Garg R. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study. Int J Clin Pediatr Dent 2017;10(1):37-40. PMID:28377653

  19. Evaluation of Quantitative Computed Tomography Cortical Hip Quadrant in a Clinical Trial With Rosiglitazone: A Potential New Study Endpoint.

    PubMed

    Miller, Colin G; Bogado, Cesar C; Nino, Antonio J; Northcutt, Allison R; Yu, Hui Jing; Lewiecki, E Michael; Paul, G; Cobitz, Alexander R; Wooddell, Margaret J; Bilezikian, John P; Fitzpatrick, Lorraine A

    2016-10-01

    Quantitative computed tomography (QCT) measurements have been used extensively to ascertain information about bone quality and density due to the 3-dimensional information provided and the ability to segment out trabecular and cortical bones. QCT imaging helps to improve our understanding of the role that each bone compartment plays in the pathogenesis and prognosis of fracture. This study was conducted to explore longitudinal changes in femoral neck (FN) cortical bone structure using both volumetric bone mineral density (vBMD) and cortical shell thickness assessments via QCT in a double-blind, randomized, multicenter clinical trial in postmenopausal women with type 2 diabetes mellitus. This study also examined whether treatment-associated changes in the cortical bone vBMD and thickness in femoral neck quadrants could be evaluated. Subjects were randomized to rosiglitazone (RSG) or metformin (MET) for 52 wk followed by 24 wk of open-label MET. A subset of 87 subjects underwent QCT scans of the hip at baseline, after 52 wk of double-blind treatment, and after 24 wk of treatment with MET using standard full-body computed tomography scanners. All scans were evaluated and analyzed centrally. Cortical vBMD at the FN was precisely segmented from trabecular bone and used to assess a possible therapeutic effect on this bone compartment. QCT analysis showed reductions in adjusted mean percentage change in vBMD and in absolute cortical thickness occurred with RSG treatment from baseline to week 52, whereas changes with MET were generally minimal. The reductions observed during RSG treatment for 1 yr appeared to partially reverse during the open-label MET phase from weeks 52 to 76. The femoral neck quadrant may provide utility as a potential endpoint in clinical trials for the understanding of the therapeutic effect of new entities on cortical bone vs trabecular bone; however, further clinical validation is needed.

  20. Pharmacokinetic study and clinical evaluation of a slow-release 5-fluorouracil implant in pancreatic cancer patients.

    PubMed

    Li, Jing Quan; Yang, Jing Chun; Liang, Jie Xiong; Wang, Shi Liang

    2016-01-01

    The aim of this research was to study the pharmacokinetic characteristics of a slow-release 5-fluorouracil implant as well as to evaluate the clinical drug activity of this preparation in pancreatic cancer patients. Pharmacokinetic characteristics of the slow-release 5-fluorouracil implant were evaluated by examining the half-life time (T1/2) and apparent volume of distribution (Vd) in pancreatic cancer patients; the slow-release 5-fluorouracil implant was administered through interstitial chemotherapy (tumor interstitium implantation). In the drug activity study, 36 locally advanced unresectable pancreatic cancer patients were divided randomly into an experimental treatment group (n=18) and a standard treatment group (n=18). The experimental treatment group was treated with interstitial chemotherapy of a slow-release 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine; the standard treatment group was treated with systemic chemotherapy of gemcitabine. An internal drainage procedure was used when biliary and/or gastrointestinal tract obstruction occurred in the two groups. Clinical benefit response, including pain (visual analogue scale), analgesic drug use, general conditions (Karnofsky performance score), weight changes, and survival status, was observed. T1/2 of the slow-release 5-fluorouracil implant was 5475.8±136.4 min, whereas Vd was 45275.0±1028.6 l. Clinical benefit response in the experimental treatment group was better than that in the standard treatment group. The experimental treatment group had longer median survival time compared with the standard treatment group. The slow-release 5-fluorouracil implant could deliver drugs mainly in the regional area of the tumor and prolong the drug action time; interstitial chemotherapy of a 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine could improve the quality of life and survival status of pancreatic cancer patients. The method was promising and worthy of

  1. Evaluation of oxidative stress in chronic periodontitis patients following systemic antioxidant supplementation: A clinical and biochemical study

    PubMed Central

    Ambati, Manasa; Rani, Koduganti Rekha; Reddy, Panthula Veerendranath; Suryaprasanna, Jammula; Dasari, Rajashree; Gireddy, Himabindu

    2017-01-01

    Context: Oxidative stress is associated with the pathogenesis of many systemic diseases including chronic periodontitis. Periodontal pathogen activated neutrophils liberate the reactive oxygen species (ROS), which causes the destruction of periodontal tissues. Antioxidants modulate the ROS production and inhibit the tissue destruction. Aim: We aimed to evaluate the oxidative stress marker malondialdehyde (MDA) in chronic periodontitis patients following scaling and root planing (SRP) after systemic lycopene supplementation. Materials and Methods: This was an interventional single arm study. Twenty systemically healthy patients with chronic periodontitis were recruited. Clinical parameters modified gingival index, probing depth, clinical attachment loss were recorded, and serum MDA levels were assessed by thiobarbituric acid reactive substances assay. Patients were supplemented with 8 mg lycopene daily for 2 months following SRP treatment. All the parameters were assessed at pretreatment and 2 months and 6 months posttreatment. Results: From pretreatment to posttreatment at 2 months, the mean values of all parameters were reduced. While from 2 to 6 months when lycopene was not administered, an increase in the mean values of all the parameters was observed; however, these values were still below baseline values. Conclusion: There was a reduction in oxidative stress and improvement in clinical parameters following systemic antioxidant therapy along with SRP, which was maintained up to 4 months after discontinuation of lycopene treatment. PMID:28250683

  2. Immunohistochemical study of skin nerve regeneration after toe-to-finger transplantation: correlations with clinical, quantitative sensory, and electrophysiological evaluations.

    PubMed

    Hsieh, Sung-Tsang; Chu, Nai-Shin

    2004-12-01

    Cutaneous nerve regeneration following toe-to-finger transplantation was studied by immunohistochemical technique using antibody to protein gene product 9.5 (PGP 9.5) which is a specific neuronal marker. By this technique, epidermal and dermal nerves were semi-quantified and the Meissner's corpuscles were quantified. There were also quantitative sensory tests (QST) including pinprick, pressure and temperature, as well as electrophysiological studies including digital nerve sensory conduction, digital nerve somatosensory evoked potentials and sympathetic skin response at the pulp of the transplanted toes. The opposite corresponding normal finger and normal toe served as controls. Study subjects were 20 adult patients with toe-to-finger transplantation for at least one year. A score system was used to quantify the results of histochemical, psychophysiological and electrophysiological studies. Clinically 7 patients had good recovery and 13 patients had poor recovery. Cutaneous nerve regeneration in the transplanted toes was incomplete with epidermal nerve, dermal nerve and the Meissner's corpuscle significantly reduced. The nerve regeneration was correlated with clinical recovery, QST and electrophysiological data. These findings indicate that immunohischemical technique is useful to evaluate skin nerve regeneration following toe-to-finger transplantation, and that although nerve regeneration did occur, it was incomplete and correlated with the severity of hand injury.

  3. Clinical evaluation of Cissus quadrangularis as osteogenic agent in maxillofacial fracture: A pilot study

    PubMed Central

    Brahmkshatriya, Hemal R.; Shah, Kruti A.; Ananthkumar, G. B.; Brahmkshatriya, Mansi H.

    2015-01-01

    Introduction: Cissus quadrangularis Linn. is an indigenous medicinal plant, grown in India, which helps to increase healing process of fractured bone. Fracture of maxillofacial skeletal takes reasonably long time to heal. Many attempts have been made till today to reduce the healing period of 6–8 weeks, by means of improved surgical technology or by inhibiting the physiological mechanism of bone healing. Aim: To evaluate the effect of C. quadrangularis in healing process of maxillofacial fracture. Materials and Methods: All the patients were treated by open reduction internal fixation method and in postoperative management, antibiotics, and analgesics. Patients were divided into two groups. In Group 1, one capsule of C. quadrangularis (500 mg) thrice a day for 6 weeks was administered (n = 5), and in Group 2 (control group), no supplementary medication was administered (n = 4). Pain, swelling, fragment mobility, serum calcium, and serum phosphorus were evaluated pre- and post-operatively on day-1, -21, and -45. Results: Pain, swelling, and fragment mobility were low in Group 1 compared to Group 2. Serum calcium and serum phosphorus were also high, and healing of bone was clearly seen in Group 1 on day 21 as compared to control group. Conclusion: C. quadrangularis helps in reducing pain, swelling, and fracture mobility and accelerate the healing of fracture jaw bones. PMID:27011718

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

    PubMed Central

    Kawabata, Edilene; Dantas, Vera Lucia; Kato, Carlos Brito; Normando, David

    2016-01-01

    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: Orthodontists and patients reported similar staining scores (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. PMID:27901229

  5. A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study

    PubMed Central

    Purra, Aamir Rashid; Mushtaq, Mubashir; Acharya, Shashi Rashmi; Saraswati, Vidya

    2014-01-01

    Aim: The purpose of this clinical study was to evaluate the efficacy of saturated ethanolic solution of Propolis for the treatment of dentin hypersensitivity. Materials and Methods: Ten patients aged 20-40 years with 156 hypersensitive teeth were selected for a 3-month study. Each patient was subjected to treatment with saturated ethanolic solution of Propolis, 5% potassium nitrate and distilled water. The patients were recalled at seventh day, 2 weeks and 4 weeks for the application of the agent and re-evaluation. The final re-evaluation of the patients was done after 3 months from the first application. The responses of the patients to the test temperatures were converted to a ranking and data was statistically analyzed. A statistical analysis was done using ANOVA and Bonferroni test and Tukey HSD test for multicomparison. Results: The results between the Propolis group and the potassium nitrate group showed no significant difference in the immediate post-treatment period; however, the results were significant at the end of first week and second week. At 4 weeks and 3 months period, a comparison between the groups again showed no significant difference. Conclusion: It was concluded that Propolis was more effective than 5% potassium nitrate in relieving dentinal hypersensitivity and had an immediate and sustained effect. PMID:25210261

  6. Evaluation of Study and Patient Characteristics of Clinical Studies in Primary Progressive Multiple Sclerosis: A Systematic Review

    PubMed Central

    Ziemssen, T.; Rauer, S.; Stadelmann, C.; Henze, T.; Koehler, J.; Penner, I.-K.; Lang, M.; Poehlau, D.; Baier-Ebert, M.; Schieb, H.; Meuth, S.

    2015-01-01

    Background So far, clinical studies in primary progressive MS (PPMS) have failed to meet their primary efficacy endpoints. To some extent this might be attributable to the choice of assessments or to the selection of the study population. Objective The aim of this study was to identify outcome influencing factors by analyzing the design and methods of previous randomized studies in PPMS patients without restriction to intervention or comparator. Methods A systematic literature search was conducted in MEDLINE, EMBASE, BIOSIS and the COCHRANE Central Register of Controlled Trials (inception to February 2015). Keywords included PPMS, primary progressive multiple sclerosis and chronic progressive multiple sclerosis. Randomized, controlled trials of at least one year’s duration were selected if they included only patients with PPMS or if they reported sufficient PPMS subgroup data. No restrictions with respect to intervention or comparator were applied. Study quality was assessed by a biometrics expert. Relevant baseline characteristics and outcomes were extracted and compared. Results Of 52 PPMS studies identified, four were selected. Inclusion criteria were notably different among studies with respect to both the definition of PPMS and the requirements for the presence of disability progression at enrolment. Differences between the study populations included the baseline lesion load, pretreatment status and disease duration. The rate of disease progression may also be an important factor, as all but one of the studies included a large proportion of patients with a low progression rate. In addition, the endpoints specified could not detect progression adequately. Conclusion Optimal PPMS study methods involve appropriate patient selection, especially regarding the PPMS phenotype and progression rate. Functional composite endpoints might be more sensitive than single endpoints in capturing progression. PMID:26393519

  7. Contract grading in clinical evaluation.

    PubMed

    Schoolcraft, V; Delaney, C

    1982-01-01

    The use of contracts in grading clinical performance has provided faculty with a solution to two important problems. One has been how to ensure that students are graded consistently among the various faculty who are grading the same clinical component of a course. The second has been to increase the opportunity for individualized attention to student learning needs. We have been pleased to see all the faculty members increase their input and involvement in the continuing modifications of the contract. Although we have taken the major responsibility for the semi-annual revisions of the contract, other faculty members have been increasingly more explicit in their evaluations and suggestions as their experience with the contract has expanded. Their confidence in this method of clinical evaluation has increased with each semester of use. We plan to continue in the refinement of the instrument and will develop materials for the use of other faculty groups who are interested in developing similar contracts. We are also designing a survey to attempt to discover how widespread is the use of contract grading in clinical areas.

  8. Clinical evaluation of carbon fiber reinforced carbon endodontic post, glass fiber reinforced post with cast post and core: A one year comparative clinical study

    PubMed Central

    Preethi, GA; Kala, M

    2008-01-01

    Aim: Restoring endodontically treated teeth is one of the major treatments provided by the dental practitioner. Selection and proper use of restorative materials continues to be a source of frustration for many clinicians. There is controversy surrounding the most suitable choice of restorative material and the placement method that will result in the highest probability of successful treatment. This clinical study compares two different varieties of fiber posts and one cast post and core in terms of mobility of crown margin under finger pressure, recurrent caries detected at the crown margin, fracture of the restoration, fracture of the root and periapical and periodontal pathology requiring crown removal over the period of 12months as evaluated by clinical and radiographical examination. Materials and Methods: 30 root canal treated, single rooted maxillary anterior teeth of 25 patients in the age range of 18–60 years where a post retained crown was indicated were selected for the study between January 2007 and August 2007; and prepared in a standard clinical manner. It was divided into 3 groups of 10 teeth in each group. After post space preparation, the Carbon fiber and Glass fiber reinforced posts were cemented with Scotch bond multipurpose plus bonding agent and RelyX adhesive resin cement in the first and second groups respectively. The Cast post and cores were cemented with Zinc Phosphate cement in the third group. Following post- cementation, the preparation was further refined and a rubber base impression was taken for metal-ceramic crowns which was cemented with Zinc Phosphate cement. A baseline periapical radiograph was taken once each crown was cemented. All patients were evaluated after one week (baseline), 3 months, 6 months and one year for following characteristics mobility of crown margin under finger pressure, recurrent caries detected at the crown margin, fracture of the restoration, fracture of the root and periapical and periodontal pathology

  9. Radiochemical studies, pre-clinical investigation and preliminary clinical evaluation of (170)Tm-EDTMP prepared using in-house freeze-dried EDTMP kit.

    PubMed

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

    2017-01-05

    The objective of the present work is to formulate (170)Tm-EDTMP using an in-house freeze-dried EDTMP kit and evaluate its potential as a bone pain palliation agent. Patient dose of (170)Tm-EDTMP was prepared with high radiochemical purity using the lyophilized kit at room temperature within 15min. 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.

  10. Evaluation of the efficacy of an hyaluronic acid-based biogel on periodontal clinical parameters. A randomized-controlled clinical pilot study

    PubMed Central

    Pilloni, Andrea; Annibali, Susanna; Dominici, Francesco; Di Paolo, Carlo; Papa, Marco; Cassini, Maria Antonietta; Polimeni, Antonella

    2012-01-01

    Summary Hyaluronic acid (HA) is an ubiquitous form of non-sulphated glycosaminoglycan of the extracellular matrix of all mammalian connective tissues. It is mainly present during tissue’s formation or during most of initial tissue’s repair processess. Cell migration, adhesion and differentiation are only part of several unique biological characteristics of HA which have been under investigation in the past decades. Aim of the study Evaluate the possible positive effect of an esterified form of HA on gingival tissues in mild chronic periodontitis patients, seeking for the reduction of all the periodontal disease clinical parameters PLI (Plaque Index), BOP (Bleeding on Probing), PPD (Probing Pocket Depth), GI (Gingival Index), PAL (Probing Attachment Level). Materials and methods The study is an open, intra-patient, controlled, single center pilot clinical trial including 19 adult patients with mild chronic periodontitis and shallow pockets (< 4 mm) in at least two different quadrants. One quadrant was treated with HA gel after regular toothbrushing (test), the other without (control). Results Although oral hygiene itself had a similar positive influence on the improvement of all the clinical indexes for test and control, the treatment with HA gel showed a greater effect almost always statistically significant. BOP in the HA gel treated areas had a decrease of 92.7% and GI of 96.5%, whereas controls 75.8% and 79.0% respectively. The difference of PPD in both areas was statistically significant (p<0.01) in favour of the HA gel treated zone. Also PAL and Pl were reduced more with gel than with oral hygiene alone, although this did not reach a statistical significant difference. Conclusion It appears that an esterified gel form of HA has shown an effect in reducing the gingival inflammation when used as an adjunct to mechanical home plaque control and that it could be successfully used to improve the periodontal clinical indexes. This pilot study will gain

  11. The USAFSAM Cardiovascular Disease Followup Study: Clinical Evaluation of Subjects Near Age 43.

    DTIC Science & Technology

    1982-08-01

    Right bundle branch block 2 Terminal IV conduction defect 10 Left bundle branch block 3 Left anterior fascicular block, persistent 2 Unclassified IV... ventricular hypertrophy (EOG only) 8 Septal hypertrophy 3 Myocardial damage 6 Atherosclerotic Coronary Disease 10 Thyroid Enlargement 3 Hypothyroldism 3...early years of the Framingham study (41), electrocardiographic evidence of left ventricular hypertrophy (LVH) in middle-aged people was iden- tified as

  12. Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation

    PubMed Central

    2016-01-01

    Background Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3–12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. Objective The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a “real world” context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. Methods A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. Results In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM

  13. Evaluating the Consent Preferences of UK Research Volunteers for Genetic and Clinical Studies

    PubMed Central

    Kelly, Susan E.; Spector, Timothy D.; Cherkas, Lynn F.; Prainsack, Barbara; Harris, Juliette M.

    2015-01-01

    Objectives To establish the views of research volunteers on the consent process; to explore their views on the consent process in different research scenarios; to inform debate on emerging models of consent for participation in research. Design, Setting and Participants 2,308 adult volunteers from the TwinsUK Registry (www.twinsuk.ac.uk) completed an online survey about their views on the consent process for use of their DNA and medical information in research. Their views on the re-consenting process in different scenarios were assessed. Results The majority of volunteers preferred to be informed of the identity of the main researcher of a study in which they are participating, which is contrary to current practice. Over 80% were willing to complete the consent process online instead of face to face. On the whole, respondents did not view their DNA differently from their medical information with regard to the consent process. Research participants were more willing to give broad consent to cover future research if their DNA was to be used by the original researcher than by another researcher, even if the disease under investigation varied, in contrast to the traditional ‘gold standard’ whereby specific consent is required for all new research projects. Discussion In some scenarios, research participants reported that they would be comfortable with not signing a new consent form for future research uses of their data and DNA, and are comfortable with secure, online consent processes rather than traditional face-to-face consent processes. Our findings indicate that the perceived relationship between research participants and researchers plays an important role in shaping preferences regarding the consent process and suggest that this relationship is not captured by traditional consent processes. We argue that the development of new formats of consent should be informed by empirical research on volunteers’ perceptions and preferences regarding the consent

  14. Hyperacuity test to evaluate vision through dense cataracts: research preliminary to a clinical study in India

    NASA Astrophysics Data System (ADS)

    Enoch, Jay M.; Giraldez, Maria J.; Huang, Doahua; Hirose, Hiroshi; Knowles, Richard A.; Namperumalsamy, P.; LaBree, Lauri; Azen, Stanley P.

    1995-03-01

    Using high luminance point-of-light stimuli, Vernier judgments can be made in the presence of markedly degraded retinal imagery. Without coaching, observers perform center-of-gravity assessments of relative locations of degraded point images. We seek to defined, presurgery, individuals who will derive the most benefit from advanced cataract removal (a form of triage), and to determine which of two cataractous eyes has the better postsurgical visual prognosis. There are incredible and growing backlogs of patients with severe cataracts (and other dense media opacities) in the developing world, and generally, limited resources are available for provision of health care. Postcataract surgical failure rates for good visual function are often high, and only one eye is operated on in over 95% of indigent patients treated. Prior to initiating advanced studies in the developing world, at Berkeley we conducted preliminary research on Vernier acuity test techniques on normal adult subjects. We sought to determine the number of repeat trials necessary; to compare a two-point and a three-point Vernier display; to determine the shape of the measured response function at large gap separations between test points (required when testing advanced cataract patients); to assess the effect(s) of a broad range of uncorrected refractive errors on outcomes; and to consider means to minimize refraction-based errors. From these and prior data and analyses, we defined a protocol for use in the developing world. Using a newly designed and rugged precision instrument, these tests were repeated on an advanced cataract population at Aravind Eye Hospital in Madurai, India. Although we had much prior experience in India, the initial protocol required major revision on site. Necessary changes in test methods and analytical approaches were made, and next stages in this program were planned. And a new and simple gap `visual acuity' (gap `VA') test was added to the protocol, which greatly facilitated

  15. Comparative Evaluation of Commercially Available Freeze Dried Powdered Probiotics on Mutans Streptococci Count: A Randomized, Double Blind, Clinical Study

    PubMed Central

    Nagaraj, Anup; Ganta, Shravani; Sidiq, Mohsin; Pareek, Sonia; Vishnani, Preeti; Acharya, Siddharth; Singh, Kushpal

    2015-01-01

    Objectives: Probiotic approaches are being considered to eliminate pathogenic microorganisms and are an alternative and promising way to combat infections by using harmless bacteria to displace pathogenic microorganisms. The aim of this study was to evaluate the effectiveness of commercially available freeze dried powdered probiotics on mutans streptococci count among 12–15 year-old Indian schoolchildren. Materials and Methods: The study was conducted in two phases of in-vitro (phase I) and in-vivo (phase II) study, which was a double blind, randomized and placebo controlled clinical trial. A total of 33 schoolchildren between 12–15 years were included in the study. They were randomly allocated to three groups. Group A included 11 children using freeze dried Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium bifidum and Bifidobacterium lactis. Group B included 11 children using freeze dried lactic acid bacillus only. Group C included 11 children using placebo powder. The study was conducted over a period of three weeks and examination and sampling of the subjects were done on days 0 (baseline), seven, 14 and 21. Results: For both the intervention groups A and B, statistically significant reduction (P<0.05) in salivary mutans streptococci counts was recorded up to the second week. Conclusion: Oral administration of probiotics showed a short-term effect on reduction of mutans streptococci count and showed a preventive role in caries development. PMID:27252756

  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

    PubMed Central

    2013-01-01

    Background 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. Methods 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. Results 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. Conclusions Multiple approaches to data

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

    PubMed

    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.

  18. An Evaluation of Use of Botulinum Toxin Type A in the Management of Dynamic Forehead Wrinkles - A Clinical Study

    PubMed Central

    Susmita, Avvaru; Kolli, Naga Neelima Devi; Meka, Sridhar; Chakravarthi, Srinivas Pandi; Lingamaneni, Krishna Prasad; Shaik, Latheef Saheb

    2016-01-01

    Introduction The pursuit of youth and beauty has undergone a resurgence of interest which is evidenced by increasing cosmetic procedures. Botulinum Toxin Type A (Botox) is one among the many procedures invented for facial rejuvenation which denervates certain muscles of facial expression responsible for facial wrinkles. It has been applied in the forehead, glabella, lateral canthal area and neck. In maxillofacial area hyperactive forehead wrinkles show sagging. Aim This study was aimed to clinically evaluate the efficacy of Botox injection in the elimination of hyperdynamic forehead wrinkles and the objectives were to compare pre-operative and post-operative improvement in the number of wrinkles, photographic grading and patient satisfaction responses after 1st week, 4th week and 16th week. Materials and Methods A total of 10 patients were randomly included in the present study who were cooperative, motivated and aesthetically conscious with moderate to severe forehead wrinkles. Assessment was performed clinically, photographically (using standardized photographs) and patient satisfaction responses were recorded at 1st week, 4th week and 16th week. Results The study showed a significant difference in the elimination of wrinkles at rest and in action when assessed at 1st week and 4th week and it was consistent at 16th week. The patient showed positive satisfaction response without ptosis of the upper eyelid. Conclusion Treatment with Botox is simple, safe and an effective modality for reduction of forehead wrinkles. It offers an alternative management in a cost-effective way when compared to surgical procedures. PMID:27891474

  19. A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial

    PubMed Central

    Ypma, Paula F; van der Meer, Pieter F; Heddle, Nancy M; van Hilten, Joost A; Stijnen, Theo; Middelburg, Rutger A; Hervig, Tor; van der Bom, Johanna G; Brand, Anneke; Kerkhoffs, Jean-Louis H

    2016-01-01

    Introduction Patients with chemotherapy-induced thrombocytopaenia frequently experience minor and sometimes severe bleeding complications. Unrestrictive availability of safe and effective blood products is presumed by treating physicians as well as patients. Pathogen reduction technology potentially offers the opportunity to enhance safety by reducing bacterial and viral contamination of platelet products along with a potential reduction of alloimmunisation in patients receiving multiple platelet transfusions. Methods and analysis To test efficacy, a randomised, single-blinded, multicentre controlled trial was designed to evaluate clinical non-inferiority of pathogen-reduced platelet concentrates treated by the Mirasol system, compared with standard plasma-stored platelet concentrates using the percentage of patients with WHO grade ≥2 bleeding complications as the primary endpoint. The upper limit of the 95% CI of the non-inferiority margin was chosen to be a ≤12.5% increase in this percentage. Bleeding symptoms are actively monitored on a daily basis. The adjudication of the bleeding grade is performed by 3 adjudicators, blinded to the platelet product randomisation as well as by an automated computer algorithm. Interim analyses evaluating bleeding complications as well as serious adverse events are performed after each batch of 60 patients. The study started in 2010 and patients will be enrolled up to a maximum of 618 patients, depending on the results of consecutive interim analyses. A flexible stopping rule was designed allowing stopping for non-inferiority or futility. Besides analysing effects of pathogen reduction on clinical efficacy, the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) is designed to answer several other pending questions and translational issues related to bleeding and alloimmunisation, formulated as secondary and tertiary endpoints. Ethics and dissemination Ethics approval was obtained in all 3

  20. Comparative field study evaluating the activity of recombinant factor VIII Fc fusion protein in plasma samples at clinical haemostasis laboratories

    PubMed Central

    Sommer, J M; Moore, N; McGuffie-Valentine, B; Bardan, S; Buyue, Y; Kamphaus, G D; Konkle, B A; Pierce, G F

    2014-01-01

    Discrepancies exist for some of the modified coagulation factors when assayed with different one-stage clotting and chromogenic substrate assay reagents. The aim of this study was to evaluate the performance of a recombinant factor VIII Fc fusion protein (rFVIIIFc), currently in clinical development for the treatment of severe haemophilia A, in a variety of one-stage clotting and chromogenic substrate assays in clinical haemostasis laboratories. Haemophilic plasma samples spiked with rFVIIIFc or Advate® at 0.05, 0.20 or 0.80 IU mL−1 were tested by 30 laboratories using their routine procedures and plasma standards. Data were evaluated for intra- and inter-laboratory variation, accuracy and possible rFVIIIFc-specific assay discrepancies. For the one-stage assay, mean recovery was 95% to 100% of expected for both Advate® and rFVIIIFc at 0.8 IU mL−1. Intra-laboratory percent coefficient of variance (CV) ranged from 6.3% to 7.8% for Advate®, and 6.0% to 10.3% for rFVIIIFc. Inter-laboratory CV ranged from 10% for Advate® and 16% for rFVIIIFc at 0.8 IU mL−1, to over 30% at 0.05 IU mL−1 for both products. For the chromogenic substrate assay, the average FVIII recovery was 107% ± 5% and 124% ± 8% of label potency across the three concentrations of Advate® and rFVIIIFc, respectively. Plasma rFVIIIFc levels can be monitored by either the one-stage or the chromogenic substrate assay routinely performed in clinical laboratories without the need for a product-specific rFVIIIFc laboratory standard. Accuracy by the one-stage assay was comparable to that of Advate®, while marginally higher results may be observed for rFVIIIFc when using the chromogenic assay. PMID:24261554

  1. The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care

    PubMed Central

    2013-01-01

    Background The appropriate care for people with cardiovascular risk factors can reduce morbidity and mortality. One strategy for improving the care for these patients involves the implementation of evidence-based guidelines. To date, little research concerning the impact of such implementation strategies in our setting has been published. Aims. To evaluate the effectiveness of a multifaceted tailored intervention in the implementation of three cardiovascular risk-related guidelines (hypertension, type 2 diabetes and dyslipidemia) in primary care in the Basque Health Service compared with usual implementation. Methods/Design A two-year cluster randomized clinical trial in primary care in two districts in the Basque Health Service. All primary care units are randomized. Data from all patients with diabetes, hypertension and those susceptible to coronary risk screening will be analyzed. Interventions. The control group will receive standard implementation. The experimental group will receive a multifaceted tailored implementation strategy, including a specific web page and workshops for family physicians and nurses. Endpoints. Primary endpoints: annual request for glycosylated hemoglobin, basic laboratory tests for hypertension, cardiovascular risk screening (women between 45–74 and men between 40–74 years old). Secondary endpoints: other process and clinical guideline indicators. Analysis: Data will be extracted from centralized computerized medical records. Analysis will be performed at a primary care unit level weighted by cluster size. Discussion The main contribution of our study is that it seeks to identify an effective strategy for cardiovascular guideline implementation in primary care in our setting. Trial registration Current Controlled Trials, ISRCTN88876909 PMID:24156549

  2. Clinical evaluation of incadronate in korean patients with malignancy-associated hypercalcemia: An open-label, multicenter study

    PubMed Central

    Kim, Sung-Bae; Lee, Jung Shin; Kim, Heung Tae; Im, Yong Hyuck; Kim, Tae Won; Ryoo, Baek Yeol; Park, Yeon Hee; Park, Joon Oh; Park, Keunchil; Katoh, Hitoshi; Yamamoto, Minoru

    2007-01-01

    Abstract Background: Incadronate has been found to lessen the increase in corrected serum calcium levels in malignancy-associated hypercalcemia (MAH) in a Phase III study in Japan. The drug is currently used to treat MAH in Japan. Objective: The purpose of this study was to assess the clinical usefulness of incadronate in patients with MAH. Methods: This open-label study was conducted at 3 medical institutions in Korea. Korean patients with MAH (corrected serum calcium levels ≥11.0 mg/dL) were given a single 10-mg IV infusion of incadronate over 2 to 4 hours in 500 to 1000 mL of normal saline. Corrected calcium levels were determined and subjective symptoms and objective findings (ie, bone pain, spontaneous pain, pain from contusion, tenderness, other pain, loss of appetite, nausea and/or vomiting, thirst, constipation, fatigue, and disturbance of consciousness) were used to monitor the effectiveness of the drug for 6 days after the infusion. Symptoms were evaluated using a 4-point scale (0 = none to 3 = severe). Adverse events (AEs) were identified by patients' reports, and adverse drug events (ADEs) were assessed by the investigators throughout the study. Results: Twenty-four Korean patients (18 [75%]male, 6 [25%]female; mean age, 56.5 years) were included in the study; data from 22 and 24 patients were used to assess effectiveness and tolerability, respectively. Corrected serum calcium level was significantly decreased on day 6 after treatment compared with pretreatment on day 0 (baseline) (9.51 [0.89] mg/dL vs 11.83 [0.89] mg/dL; P < 0.001). The antihypercalcemic effect of incadronate became apparent as an inhibition of bone absorption a few days after infusion. Corrected serum calcium level was significantly decreased on days 2 to 6 (P < 0.001) after treatment compared with pretreatment at baseline. Evaluation of symptoms showed significant improvement in the incadronate-treated group (mean total score [range] at baseline, 8 [1–23] and day 6, 5.5 [1–17

  3. [Possibilities for the improvement of the quality of knowledge and their evaluation in the course of studying clinical medicine].

    PubMed

    Tetenev, F F; Bodrova, T N; Ageeva, T S; Karzilov, A I; Kalinina, O V

    2014-01-01

    The authors consider objective and subjective factors exerting negative influence on the quality of knowledge of physicians. The generally accepted methods for its evaluation (testing and rating-systems) have limitations. Testing reflects the level of knowledge with respect to the mode of thinking of its designer while rating mostly characterizes diligence of the trainee. It is proposed to improve the quality of knowledge by teaching the theory of diagnostics and to evaluate the amount of knowledge from the contents of the descriptive part of the medical history. The quality of knowledge can be assessed based on the contents of professional comments on the clinical picture described in the model case history.

  4. Implementation of post treatment critical evaluation improved the quality of orthodontic care in postgraduate orthodontic clinic: A 10 years comparative study

    PubMed Central

    Verma, Rashmi; Utreja, Ashok Kumar; Singh, Satinder Pal; Jena, Ashok Kumar

    2015-01-01

    Objective: The aim of the study was to evaluate the effect of post- treatment critical evaluation on the quality of orthodontic care in a postgraduate orthodontic clinic. Materials and Methods: Orthodontic treatment outcome of 109 consecutively treated cases was evaluated in Phase-I evaluation. Following Phase-I evaluation, PTCE of each case was made mandatory. After 6-years of implementation of compulsory PTCE for each case, orthodontic treatment outcome of all consecutively treated cases (n = 126) was evaluated (Phase-II). The treatment outcome was evaluated by American Board of Orthodontics Model Grading System (ABO MGS) and Subjective evaluation (Visual Analogue Scale, VAS). Results: Based on the ABO scores, the cases were divided into three grades, that is, Grade-I, Grade-II, and Grade-III. The mean total ABO score was improved significantly in Phase-II evaluation (P < 0.01). The total number of cases in ABO Grade-II were increased significantly (P < 0.01) whereas cases in ABO Grade-I remained comparable. The VAS score was improved from 5.66 ± 0.77 at Phase-I to 6.02 ± 0.99 at Phase-II evaluation (P < 0.01). Conclusion: The implementation of PTCE significantly improved the quality of orthodontic care in a postgraduate orthodontic clinic. Clinical Significance: Grading one's own treatment improves the quality of future treatment. PMID:26392728

  5. [Clinical evaluation of living donor].

    PubMed

    Scolari, Maria Piera; Comai, G; La Manna, G; Liviano D'Arcangelo, G; Monti, M; Feliciangeli, G; Stefoni, S

    2009-01-01

    When possible, living donor transplantation represents the best therapeutic strategy for patients suffering from chronic renal failure. Studying the donor allows a complete and thorough clinical, laboratory and instrumental assessment that guarantees good organ function whilst protecting the health of the donor. The main parameters considered within this framework are age, renal function, nephrological complications, comorbidities (diabetes, hypertension, obesity, etc.), malignancies, and infection. Moreover, particular attention is paid to the sociopsychological aspects of the donation, particularly related to the donor, the recipient, and the entire family situation.

  6. Mathematical evaluation of the influence of multiple factors on implant stability quotient values in clinical practice: a retrospective study

    PubMed Central

    Huang, Hairong; Wismeijer, Daniel; Shao, Xianhong; Wu, Gang

    2016-01-01

    Objectives The objective of this study is to mathematically evaluate the influence of multiple factors on implant stability quotient values in clinical practice. Patients and methods Resonance frequency analysis was performed at T1 (measured immediately at the time of implant placement) and at T2 (measured before dental restoration) in 177 patients (329 implants). Using a multivariate linear regression model, we analyzed the influence of the following eleven candidate factors: sex, age, maxillary/mandibular location, bone type, immediate/delayed implantation, bone grafting (presence or absence), insertion torque, I-/II-stage healing pattern, implant diameter, implant length, and T1–T2 time interval. Results The following factors were identified to significantly influence the implant stability quotient (ISQ) values at T1: insertion torque, bone grafting, I-/II-stage healing pattern, immediate/delayed implantation, maxillary/mandibular location, implant diameter, and sex. In contrast, the ISQ values at T2 were significantly influenced only by three factors: implant diameter, T1–T2 time interval, and insertion torque. Conclusion Among the eleven candidate factors, seven key factors were found to influence the T1-ISQ values, while only three key factors influenced the T2-ISQ values. Both T1 and T2-ISQ values were found to be influenced by implant diameter and insertion torque. T1 was influenced specifically by the sex of the patient, the location (maxillary or mandibular), the implantation mode (immediate/delayed implantation), the healing stage, and the absence or presence of bone graft materials. PMID:27785040

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

    PubMed

    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.

  8. Evaluation of spasticity after stroke by using ultrasound to measure the muscle architecture parameters: a clinical study

    PubMed Central

    Yang, Yuan-Bin; Zhang, Jing; Leng, Zhen-Peng; Chen, Xin; Song, Wei-Qun

    2014-01-01

    Objective: This study aims to compare the difference and the change trend of Muscle Architecture Parameters (MAP) between spastic and normal muscle tone patients after stroke, and analysis the application and value of Muscle Architecture Parameters in evaluating spasticity after stroke. Methods: 41 stroke patients were divided into spastic group (26 cases), normal muscle tone control group (15 cases). Modified Ashworth Scale (MAS) was applied in both groups for assessing muscle tone of lower limbs (no influence, contralateral). Muscle architectural parameters of ultrasound measurement include muscle thickness, fascicle length and pennation angle. The difference of three muscle architectural parameters between the affected side and the contralateral side in spastic group and the difference of MAS and three muscle architectural parameters between spastic group and normal control group were compared. Results: MAS score, Pennation Angle (PA) and Muscular Thickness (MT) value of MAP in spastic group were significantly higher than the control group, Fascicle length (FL) is significantly lower than the control group (P < 0.05). In spastic group, MAS score, PA and MT value of MAP of affected side muscle was substantially higher than that of contralateral, FL value significantly lower than that of contralateral (P < 0.05). There was positive correlation between MAS and PA and MT but was negative correlation between MAS and FL, rank correlation coefficient test was statistical significant (p < 0.05). Logistic multivariate regression analysis showed that spasticity can lead PA and FL to change (p < 0.05), there is no clear correlation between MT and spasticity occurs (P > 0.05). Conclusion: MAP has a better sensitivity in evaluating muscle tone between spastic patients and non-spastic patients, and degrees of spasticity have a clear corresponding exponential relationship to MAP. Combing MAS and MAP can assess muscle tone more objectively and accurately because subtle changes

  9. Integrated care for asthma: a clinical, social, and economic evaluation. Grampian Asthma Study of Integrated Care (GRASSIC)

    PubMed Central

    1994-01-01

    OBJECTIVES--To evaluate integrated care for asthma in clinical, social, and economic terms. DESIGN--Pragmatic randomised trial. SETTING--Hospital outpatient clinics and general practices throughout the north east of Scotland. PATIENTS--712 adults attending hospital outpatient clinics with a diagnosis of asthma confirmed by a chest physician and pulmonary function reversibility of at least 20%. MAIN OUTCOME MEASURES--Use of bronchodilators and inhaled and oral steroids; number of general practice consultations and hospital admissions for asthma; sleep disturbance and other restrictions on normal activity; psychological aspects of health including perceived asthma control; patient satisfaction; and financial costs. RESULTS--After one year there were no significant overall differences between those patients receiving integrated asthma care and those receiving conventional outpatient care for any clinical or psychosocial outcome. For pulmonary function, forced expiratory volume was 76% of predicted for integrated care patients and 75% for conventional outpatients (95% confidence interval for difference -3.6% to 5.0%). Patients who had experienced integrated care were more likely to select it as their preferred course of future management (75% (251/333) v 62% (207/333) (6% to 20%)); they saved 39.52 pounds a year. This was largely because patients in conventional outpatient care consulted their general practitioner as many times as those in integrated care, who were not also visiting hospital. CONCLUSION--Integrated care for moderately severe asthma patients is clinically as effective as conventional outpatient care, cost effective, and an attractive management option for patients, general practitioners, and hospital consultants. PMID:8148678

  10. The clinical information system implementation evaluation scale.

    PubMed

    Gugerty, Brian; Maranda, Michael; Rook, Dona

    2006-01-01

    Measurement instruments to assess user satisfaction with Clinical Information Systems (CIS) and with the implementation of CIS are needed as part of multi-faceted evaluation of CIS. Seven years of experience in developing measurement instruments to assess staff satisfaction with CIS preceded the development effort that created the Clinical Information System Evaluation Scale (CISIES). The scale was developed using precursors of the CISIES and it was guided by an expert panel. Following its construction the 37-item measurement instrument was piloted as part of the assessment of a Critical Care Clinical Information System implementation at a medical center in Florida, USA. Results indicated satisfaction with the implementation, although not strong, at the time of administration. The results of the CISIES administration were used by informaticians at the research site to plan and execute an intervention to improve satisfaction with the implementation. Re-administration of the CISIES at the site to evaluate the success of this intervention is planned. The CISIES was found to be a useful instrument, easy to administer, acceptable to respondents, easy to score and understandable by non-researcher at the study site. Early indications are that it will be useful in the formative and summative evaluation of CIS implementations.

  11. Evaluating student performance in clinical dietetics.

    PubMed

    Novascone, M A

    1985-06-01

    The focus of this study was on the development and field-testing of a set of behaviorally anchored rating scales for evaluating the clinical performance of dietetic students. The scales emphasized the application of skills and knowledge. A variation of the Smith-Kendall technique was used to develop the scales. The 42 participants involved in instrument development included dietetic students, didactic and clinical instructors, and dietetic practitioners. The completed instrument contained 8 dimension statements and 70 behavioral anchors. The instrument was field-tested in 16 clinical rotations within 8 dietetic education programs. Evaluators not only rated student performance but also critiqued the format and content of the scales. The mid-to-upper portions of each scale were used most frequently, and little score variation within or across programs was noted. The scales were deemed appropriate for formative evaluation; however, some evaluators who had to grade students' performance expressed a desire for performance standards defined in terms of grades. Because the process used to develop the instrument facilitated the articulation of performance criteria, it is recommended as a practical approach to setting performance standards.

  12. PROMIS — Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer☆

    PubMed Central

    El-Shater Bosaily, A.; Parker, C.; Brown, L.C.; Gabe, R.; Hindley, R.G.; Kaplan, R.; Emberton, M.; Ahmed, H.U.

    2015-01-01

    Background Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway. Methods PROMIS is a prospective validating paired-cohort study that meets criteria for level 1 evidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-MRI can discriminate between men with and without clinically-significant prostate cancer who are at risk prior to first biopsy. Up to 714 men will have MP-MRI (index), 10–12 core TRUS-biopsy (standard) and 5 mm transperineal template mapping (TPM) biopsies (reference). The conduct and reporting of each test will be blinded to the others. Results PROMIS will measure and compare sensitivity, specificity, and positive and negative predictive values of both MP-MRI and TRUS-biopsy against TPM biopsies. The MP-MRI results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is defined as Gleason grade >/= 4 + 3 and/or maximum cancer core length of ≥ 6 mm. PROMIS will also assess inter-observer variability among radiologists among other secondary outcomes. Cost-effectiveness of MP-MRI prior to biopsy will also be evaluated. Conclusions PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer. PMID:25749312

  13. Experimental studies: randomized clinical trials.

    PubMed

    Gjorgov, A N

    1998-01-01

    There are two major approaches to medical investigations: observational studies and experimental trials. The classical application of the experimental design to studies of human populations is the randomized clinical trial of the efficacy of a new drug or treatment. A further application of the experimental studies is to the testing of hypotheses about the etiology of a disease, already tested and corroborated from various forms of observational studies. Ethical considerations and requirements for consent of the experimental subjects are of primary concern in the clinical trials, and those concerns set the first and final limits for implementing a trial. General moral principles in research with human and animal beings, defined by the "Nuremberg Code," deal with strict criteria for approval, endorsement and evaluation of a clinical trial.

  14. Evaluating Clinical Teaching in Medicine.

    ERIC Educational Resources Information Center

    Irby, David; Rakestraw, Philip

    1981-01-01

    Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)

  15. Clinical Evaluation of Proclination of Lower Anterior Teeth during Alignment using a Single Width Bracket-A Pilot Study

    PubMed Central

    Farhan, Azeem; Issar, Rashmi; Subramanian, Shashikala; Muniyappa, Manju Prasad; Ranjan, Shashi; Singh, Priyankar; Singh, Kumar Tathagat

    2016-01-01

    Introduction The pre-adjusted brackets are available in various prescriptions and sizes; nevertheless there are still many controversies as to which pre-adjusted edgewise bracket offers the maximum clinical efficiency. Aim This study was conducted to determine and compare the amount of lower incisor proclination during de-crowding if any of the Mini-Uni Twin Brackets with that of the standard double width brackets. Materials and Methods A total of 20 patients i.e., 10 patients in each group both males and females were randomly selected for the study from subjects seeking treatment, the selected samples were grouped as follows. Group I – Double Width Brackets (3M Unitek Gemini Series) 0.018” slot with Roth prescription. Group II – Mini Uni-Twin Bracket (3M Unitek) 0.018” slot with Roth prescription. Results The Mini-Uni Twin Brackets had statistically significant (p = 0.01) amount of proclination of the lower anteriors (0.8o± 0.3o) after de-crowding as compared to the standard Double Width Brackets and since the mean change in the Incisor Mandibular Plane Angle (IMPA) was lesser than 1o, its clinical significance could be questionable. Conclusion The Mini Uni Twin brackets are comparatively efficient in the lower anterior decrowding but further comparative clinical studies need to be performed on these Mini Uni Twin brackets, with an increase in the sample size and also the number of parameters to prove its total clinical efficiency. PMID:27504401

  16. Clinical Evaluation of Success of Primary Teeth Pulpotomy Using Mineral Trioxide Aggregate®, Laser and BiodentineTM- an In Vivo Study

    PubMed Central

    Prasad, Madhu Ghanshyam; Vasa, Aron Arun Kumar; Divya, Gaddam; Thakur, Mukesh Singh; Saujanya, Kanithi

    2015-01-01

    Introduction Pulpotomy technique basically consists of removing the coronal pulp and fixing the radicular pulp with a medicament. It is the most widely accepted clinical procedure for treating primary teeth with coronal pulp inflammation caused by caries with no involvement of the radicular pulp. Aim To evaluate the success and efficacy of Mineral Trioxide Aggregate (MTA), Lasers and Biodentine as pulpotomy agents both clinically and radiographically. Materials and Methods In the present study, 60 primary molars in children whose pulpal status warranted pulpotomy were selected and randomly assigned into three groups that included MTA, Laser and Biodentine allocating 20 teeth to each group. The pulpotomy procedure was then performed on all selected teeth followed by restoration with stainless steel crowns. Later the patients were recalled for 3 months and 6 months for clinical and radiographic evaluation. Results Statistical analysis was done using Fisher exact test to determine pair wise comparison of three agents with respect to clinical and radiographic criteria. Kruskal-Wallis ANOVA, Mc Nemars test was applied to evaluate the efficacy of each agent between 3 months and 6 months. The results showed that maximum success rate was found in MTA group. However, the comparison between three groups was statistically not significant (p<0.05). Conclusion Pulpotomies performed with either MTA, Laser or Biodentine are equally efficient with similar clinical/radiographic success and hence can be considered as alternatives to Formocresol. PMID:26023640

  17. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study

    PubMed Central

    Hugar, Shivayogi M; Hugar, Shweta S; Gokhale, Niraj; Assudani, Harsha

    2017-01-01

    Aims Despite various advents in technology, the present era marks a shift to phytotherapeutics and alternative modalities to conventional endodontic treatments. Newer endodontic modalities have been developed inculcating the ancient system of medicine. The present study was done to compare and evaluate the clinical pulp response and radiographic signs after pulpotomy in four groups of primary molar teeth treated with formocresol (control), propolis extract, turmeric gel, and calcium hydroxide respectively. Materials and methods Following ethical clearance, 90 primary molar teeth in 45 pediatric patients, aged between 4 and 9 years, were selected for pulpotomy. These were then randomly divided by split-mouth technique into two groups as experimental (propolis extract/turmeric gel/calcium hydroxide) and control (formocresol) groups. The patients were followed up for 6 months for clinical and radiographic signs and symptoms to evaluate the success of treatment. Results A comparable clinical and radiographic success rate was seen with all experimental groups as compared to the control (formocresol) group. Conclusion With concerns about the safety of formocresol appearing in the dental and medical literature for more than 20 years, the materials used in this study can be considered as promising alternatives for formocresol in pediatric endodontic treatment. How to cite this article Hugar SM, Kukreja P, Hugar SS, Gokhale N, Assudani H. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study. Int J Clin Pediatr Dent 2017;10(1):18-23. PMID:28377649

  18. Mucosal function and breath hydrogen excretion: comparative studies in the clinical evaluation of children with nonspecific abdominal complaints.

    PubMed

    Barr, R G; Watkins, J B; Perman, J A

    1981-10-01

    To evaluate the role of the lactose breath hydrogen test for the detection of lactose malabsorption in children with chronic nonspecific abdominal complaints, breath hydrogen excretion was measured in 131 children with recurrent abdominal pain (n = 75) or chronic nonspecific diarrhea (n = 56) following a lactose load (2 gm/kg; maximum 50 gm). The data were compared to those obtained from lactose tolerance tests (n = 113) and symptom response following a lactose load (n = 109) performed simultaneously with the lactose breath hydrogen test, and with results from small bowel biopsies obtained in 31 children to determine dissacharidase activity and mucosal histology. The results indicate that an increase in breath hydrogen of greater than 10 ppm above base line values (delta ppm) by 120 minutes ("early increase" response) completely discriminates between biopsy-proven isolated lactase-insufficient and lactase-sufficient children. A similar increase after 120 minutes ("late increase" response) is consistent both with normal mucosal function and partial lactase insufficiency due to mucosal injury. Breath hydrogen responses predicted assayed lactase activity in all patients with isolated lactase insufficiency, but were "falsely negative" in four of ten children whose lactase insufficiency was secondary to mucosal injury. In both clinical groups, lactose malabsorbers report significantly more symptoms than absorbers (P less than .001), but neither symptom reports nor tolerance tests are accurate methods for distinguishing lactose malabsorbers from absorbers. Although the lactose breath hydrogen test provides objective documentation of lactose malabsorption, it is equally predictive of assayed lactase activity in all clinical groups.

  19. Clinical judgment: the last frontier for evaluation.

    PubMed

    Lasater, Kathie

    2011-03-01

    Nursing educators and preceptors often find it difficult to evaluate prelicensure students' clinical judgment development. Clinical judgment is critical to excellent patient care decisions and outcomes. The Lasater Clinical Judgment Rubric, a validated, evidence-based clinical judgment rubric, is described as a tool that offers a common language for students, nurse educators, and preceptors and a trajectory for students' clinical judgment development. The rubric has been used to provide feedback for reflective journals and a means for self-evaluation in addition to a guide for formulating higher level thought questions to shape students' thinking like a nurse.

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

    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...

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

    PubMed

    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.

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

    PubMed

    2009-08-01

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

  3. The Effect of Formative Program Evaluation on Continuous Program Improvement: A Case Study of a Clinical Training Program in Lao PDR.

    PubMed

    Yoon, Hyun Bae; Shin, Jwa-Seop; Lee, Seung-Hee; Kim, Do-Hwan; Hwang, Jinyoung; Kim, Eun Jung; Bouphavanh, Ketsomsouk

    2015-12-01

    This study aimed to evaluate the effect of the formative program evaluation on the continuous improvement of a clinical training program for Lao health professionals. The training program was conducted 4 times consecutively for total 48 health professionals, and the formative program evaluation was carried out during the whole process. To evaluate the satisfaction and the transfer of the trainees, the questionnaire survey, the focus group interview, and the trainees' medical records were used. After the end of each batch of the program, the evaluation data were analyzed, and its results were shared with the training management committee and the trainers, who, based on the results, reached a consensus on how to improve the program. The evaluation results and the comparison of them among the four batches of the program showed that there was a continuous increase of the satisfaction and the transfer of the trainees, especially in the early period of the program. The formative program evaluation which was conducted during the whole process of the clinical training program had a positive effect on the improvement of the program, especially in the early phase, by increasing the satisfaction and transfer of the trainees.

  4. Clinical evaluation of clobetasone butyrate: a comparative study of its effects in postoperative inflammation and on intraocular pressure.

    PubMed Central

    Ramsell, T G; Bartholomew, R S; Walker, S R

    1980-01-01

    Clobetasone butyrate, a new corticosteroid with a high topical activity, has been compared with prednisolone phosphate and a placebo in the treatment of inflammation following cataract extraction. These 2 steroids were more effective in relieving postoperative inflammation than placebo (P less than 0.05), though no obvious clinical differences between the 2 compounds emerged from this investigation. However, a single-blind comparative study against betamethasone phosphate in patients suspected of having steroid-induced glaucoma showed that, while betamethasone phosphate significantly raised intraocular pressure, clobetasone butyrate had only a minimal effect, and this difference was statistically significant (P less than 0.02). PMID:6986899

  5. [Evaluation of eight Clinical Protocols and Therapeutic Guidelines under the Brazilian Ministry of Health using the AGREE II instrument: a pilot study].

    PubMed

    Ronsoni, Ricardo De March; Pereira, Claudia Cristina de Aguiar; Stein, Airton Tetelbom; Osanai, Mário Henrique; Machado, Carla Jorge

    2015-06-01

    The number of clinical guidelines is increasing worldwide, while there are concerns regarding their quality. In 2000, the Brazilian Ministry of Health began its process of creating clinical guidelines, called Clinical Protocols and Therapeutic Guidelines (PCDT). The goal of this study was to assess the quality of Brazilian guidelines approved since 2009 using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation). We identified 59 PCDT from 2009 to 2012, of which eight were randomly selected and evaluated by three independent evaluators. For the item "recommends the guidelines", two evaluators recommended the use of all eight, but with modifications, and one did not recommend any to the guidelines. Regarding the item "global quality of the guidelines" (varying from 1 to 7), the mean was 4.25 (SD = 0.46). The results showed the need for adjustments in the PCDT in relation to AGREE II domains. However, due to the instrument's limitations, further studies are needed, including the quality of evidence used in the PCDT.

  6. Detection and Evaluation of Early Breast Cancer via Magnetic Resonance Imaging: Studies of Mouse Models and Clinical Implementation

    DTIC Science & Technology

    2007-03-01

    fibrocystic change (FCC), fibroadenoma , papilloma and other. Two-tailed unequal variance Student’s t-tests were performed to evaluate which parameters...lesions ( fibroadenoma , papilloma and FCC). Receiver operating characteristic (ROC) analysis was performed to compare the diagnostic capability of the...studied here. Some typical examples of the modified EMM fits are shown in Fig. 1 for various benign (top row – FCC, fibroadenoma , and papilloma) and

  7. Evaluation of a moisturising micro-gel spray for prevention of cell dryness in oral mucosal cells: an in vitro study and evaluation in a clinical setting.

    PubMed

    Ota, Y; Morito, A; Fujisawa, K; Nishida, M; Hata, H; Ueno, T; Yurikusa, T; Murata, T

    2012-11-01

    A moisturising micro-gel spray for prevention of dryness was compared with commercial products and artificial saliva in vitro and in a clinical setting in patients with cancer. Survival of cultured human gingival epithelial cells was evaluated after treatment with each product for 15 min. A dry test was performed for products giving a 50% survival rate, in which cell survival was measured after drying of cells treated with each product. The survival rates of cells treated with the micro-gel spray and artificial saliva were significantly higher than those of control cells. The micro-gel spray was then evaluated for 1 week in patients with symptoms of dry mouth caused by cancer treatment. There was significant improvement of these symptoms at night and on awakening and of subjective symptoms of decreased salivary volume (P < 0.05). Mean visual analogue scale scores also significantly decreased (P < 0.01). These data suggest that evaluation of moisturising products for dryness prevention can be performed in cultured cells, since products that performed well in vitro also showed good efficacy for symptoms of dry mouth. The micro-gel spray was particularly effective for relieving symptoms of dry mouth in patients with cancer.

  8. Evaluation of a moisturising micro-gel spray for prevention of cell dryness in oral mucosal cells: an in vitro study and evaluation in a clinical setting

    PubMed Central

    Ota, Y; Morito, A; Fujisawa, K; Nishida, M; Hata, H; Ueno, T; Yurikusa, T; Murata, T

    2012-01-01

    A moisturising micro-gel spray for prevention of dryness was compared with commercial products and artificial saliva in vitro and in a clinical setting in patients with cancer. Survival of cultured human gingival epithelial cells was evaluated after treatment with each product for 15 min. A dry test was performed for products giving a 50% survival rate, in which cell survival was measured after drying of cells treated with each product. The survival rates of cells treated with the micro-gel spray and artificial saliva were significantly higher than those of control cells. The micro-gel spray was then evaluated for 1 week in patients with symptoms of dry mouth caused by cancer treatment. There was significant improvement of these symptoms at night and on awakening and of subjective symptoms of decreased salivary volume (P < 0.05). Mean visual analogue scale scores also significantly decreased (P < 0.01). These data suggest that evaluation of moisturising products for dryness prevention can be performed in cultured cells, since products that performed well in vitro also showed good efficacy for symptoms of dry mouth. The micro-gel spray was particularly effective for relieving symptoms of dry mouth in patients with cancer. PMID:22519950

  9. Clinical efficacy of certain Unani herbs in knee osteoarthritis: A pretest and post-test evaluation study

    PubMed Central

    Tarannum, Asfia; Sultana, Arshiya; Ur Rahman, Khaleeq

    2016-01-01

    Objectives: This study was conducted to evaluate the efficacy of preparations of certain Unani herbs on Lequesne Algo-Functional Index of knee osteoarthritis (OA). Materials and Methods: A prospective, pre- and post test evaluation study was conducted on 20 diagnosed patients of OA recruited from the Nizamia General Hospital, Hyderabad. Internally, a combination (formula) of Unani herbs was administered, which was as follows: 3.5 g powder of Asarun (2 g), Tukhme karafs (2 g), and Filfil daraz (3 g) was administered internally twice daily. Externally, the concoction of Gule baboona (20 g) and Gule tesu (40 g) made in 1 l water was poured over the affected knee, daily once for 40 days. The primary outcome was to assess the efficacy of Unani test drugs with the modified Lequesne Algo-Functional Index for knee OA. Results: The mean percentage reduction of Lequesne Algo-Functional Index score was 71.09%. The mean and standard deviation was 10.55 (1.70) and 3.05 (2.30) before treatment and after treatment, respectively. The pre- and post test evaluation showed reduction in Lequesne Algo-Functional Index score (P < 0.0001). Conclusion: In this study, the Unani treatment module was found to be effective in reducing the severity of disease in patients with osteoarthritis of knees. PMID:27621521

  10. Evaluation of “Subject Advocate” Procedures in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia Study

    PubMed Central

    Stroup, T Scott; Appelbaum, Paul S

    2006-01-01

    Because the decision-making capacity of individuals with schizophrenia may fluctuate, additional protections for such persons who enroll in long-term research studies may be needed. For the NIMH-sponsored Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study, new procedures were developed to help ensure an objective assessment of a patient's continued participation in the study if decision-making capacity lapsed. Each research participant had a subject advocate who could recommend that the subject be withdrawn from the study if capacity lapsed and continued participation was not in the subject's best interest. The main goals of the procedures were to protect the interests of subjects and to prevent unnecessary dropouts. We surveyed research personnel regarding the effectiveness and implementation of the procedures. Responses were received from 73 personnel at 49 research sites, representing 70% of possible respondents and 91% of eligible sites. A majority of respondents were favorably disposed toward subject advocates, and though most reported that the procedures had no discernible effect on study recruitment, subject autonomy, or subject retention, for those who reported an impact, it was almost always positive. Some respondents reported that the procedures helped by engaging family members and promoting a positive view of schizophrenia research. A majority thought that similar arrangements would be useful in future longitudinal research studies. Nonspecific benefits included good public relations and engagement of family members. Improved training regarding the procedures may be needed to achieve specific goals of enhanced patient autonomy and retention in the study. PMID:16282635

  11. Clinical Performance of Prediction Rules and Nasogastric Lavage for the Evaluation of Upper Gastrointestinal Bleeding: A Retrospective Observational Study

    PubMed Central

    Dakik, Hassan K.; Srygley, F. Douglas; Chiu, Shih-Ting; Chow, Shein-Chung

    2017-01-01

    Introduction. The majority of patients with acute upper gastrointestinal bleeding (UGIB) are admitted for urgent endoscopy as it can be difficult to determine who can be safely managed as an outpatient. Our objective was to compare four clinical prediction scoring systems: Glasgow Blatchford Score (GBS) and Clinical Rockall, Adamopoulos, and Tammaro scores in a sample of patients presenting to the emergency department of a large US academic center. Methods. We performed a retrospective cohort study of patients during 2008–2010. Our outcome was significant UGIB defined as high-risk stigmata on endoscopy, or receipt of blood transfusion or surgery, or death. Results. A total of 393 patients met inclusion criteria. The GBS was the most sensitive for detecting significant UGIB at 98.30% and had the highest negative predictive value (90.00%). Adding nasogastric lavage data to the GBS increased the sensitivity to 99.57%. Conclusions. Of all four scoring systems compared, the GBS demonstrated the highest sensitivity and negative predictive value for identifying a patient with a significant UGIB. Therefore, patients with a 0 score can be safely managed as an outpatient. Our results also suggest that performing a nasogastric lavage adds little to the diagnosis UGIB. PMID:28246528

  12. Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

    PubMed Central

    Pellicoro, C.; Marsella, R.; Ahrens, K.

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

  13. Pilot study to evaluate the effect of topical dimethicone on clinical signs and skin barrier function in dogs with naturally occurring atopic dermatitis.

    PubMed

    Pellicoro, C; Marsella, R; Ahrens, K

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis.

  14. Evaluation of Anti-Inflammatory Effects of Curcumin Gel as an Adjunct to Scaling and Root Planing: A Clinical Study

    PubMed Central

    Anuradha, B R; Bai, Yendluri Durga; Sailaja, Sambhana; Sudhakar, Jaradoddi; Priyanka, M; Deepika, V

    2015-01-01

    Background: Complete removal of irritants is not possible with mechanical therapy alone. Adjunctive use of systemic administration of antibiotics results in the distribution of drug throughout the body, which can give rise to toxicity. Curcumin (diferuloylmethane), a constituent of Curcuma longa plant, which possess antioxidant, anti-inflammatory, anti-carcinogenic, anti-microbial, anti-hyper algesic and hypocholesterolemic properties. The aim of the present study is to compare the effects of the curcumin gel as an adjunct to subgingival scaling and root planning with the effect achieved using subgingival scaling and root planning alone. Materials and Methods: Thirty patients either male or female with chronic localized or generalized periodontitis aged between 25 and 60 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites were included. In the experimental site scaling and root planning was performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, subgingival scaling alone was performed followed by periodontal pack application. Parameters included were: Plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment loss. These parameters were recorded on day 0, 30 and 45 days. Results: Significant reduction in mean was observed in PI, GI, PD and gain in clinical attachment level were demonstrated in both the groups from baseline to 45 days. However, statistical significant reduction was observed in PI at baseline and 30th day and GI at 30th day. Conclusion: Curcumin can be effectively used along with scaling and root planning. Future research is required to determine the long-term effects of curcumin on a large sample of subjects. PMID:26229378

  15. EVALUATION OF A COMBINATION OF A UNANI PHARMACOPEAL PREPARATION (ITRIFAL USTUKHUDOOS) WITH CLOVES (QARANFAL) IN ALLERGIC RHINITIS – A PRELIMINARY CLINICAL STUDY

    PubMed Central

    Hussain, Syed Asif; Khan, A.B.; Siddiqui, M.Y.; Latafat, T.; Kidwai, T.

    2003-01-01

    Allergic Rhinitis is typically characterized by sneezing, rhinorrhoea, nasal obstruction, nasal, conjunctival & pharyngeal itching and lacrimation all occurring in a temporal relation to allergen exposure. The peak incidence of this disease occurs in childhood and adolescence, with most of the cases belonging to the atopic category. There is a high incidence of patients of allergic rhinitis attending the outdoor sections of Ajmal Khan Tibbiya College Hospital. Many of them are dissatisfied with conventional anti-histaminic drugs. An open study was carried out on 20 such patients aged between 15 to 50 years to evaluate the clinical efficacy of a unani pharmacopeal preparation [Itrifal ustukhudoos] added with cloves [qaranfal]. Preliminary clinical study showed promising results. The study is into the next phase in which a comparative double-blind trial is being conducted with this combination and Allegra (Fexofenadine hydrochloride). PMID:22557103

  16. An evaluation of service utilization among male to female transgender youth: qualitative study of a clinic-based sample.

    PubMed

    Corliss, Heather L; Belzer, Marvin; Forbes, Catherine; Wilson, Erin C

    2007-01-01

    This qualitative study examined experiences with health and social service institutions and experiences related to education, employment, and other social networks among 18 ethnically diverse, male to female (MTF) transgender youth aged 16 to 24 years. Participants were recruited from a youth health clinic where they were receiving services for their transgender/transsexual identity. In-depth, semi-structured interviews explored youths' patterns of service utilization, reasons for seeking care, beliefs about the usefulness of services received, experiences with service providers, barriers to care, and suggestions for improving services tailored to them. Similar to other studies with this population, participants described a multitude of health and social risk experiences as well as complex needs related to healthcare, education, employment, housing, personal relationships, and safety. Results suggest a mixed pattern of both positive and negative experiences within the medical, social and mental health services arenas. To improve support for transgender youth and assist in their positive development, it is essential to improve and expand the availability of culturally competent and effective services for this population.

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

    PubMed Central

    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

  18. Clinical evaluation of 262 osseointegrated implants placed in sites grafted with calcium phosphosilicate putty: a retrospective study.

    PubMed

    Babbush, Charles A; Kanawati, Ali

    2015-02-01

    Along with the widespread use of dental implants, regenerative procedures have become an indispensable tool for implant surgeons in managing residual ridges and the surrounding bone. Putty bone grafts have significantly superior handling characteristics in comparison to particulates. These include ease of placement, enhanced particle containment, and a viscous consistency that has allowed for unique delivery systems to be developed. The aim of this study was to report the clinical efficacy of calcium phosphosilicate (CPS) putty in a wide variety of indications related to implant reconstruction and to report the survival rate of implants placed in these grafted sites. The CPS putty was used as the graft material of choice. Treatments were categorized into following groups: extraction graft, extraction with immediate implant placement, all-on-four concept, peri-implantitis treatment, bone augmentation before implant placement, implant replacement graft, and grafting around implant placed in resorbed ridges. Included in the analysis were 65 patients (36 men, 29 women) with a mean age of 63 ± 12 years. In total, 262 implants were placed. Four implants were diagnosed with peri-implantitis and were treated as described in category 4, for a total of 266 grafted sites. Two implants from the extraction graft category and 3 implants from the all-on-four group were lost and replaced with successfully osseointegrated implants during a mean study follow-up period of 12.24 ± 2.32 months. The implant success rate at 1 year was 98.1% (257/262). Based on results of this large-scale, retrospective study we conclude that (1) the use of putty bone grafts can simplify bone-grafting procedures and reduce intraoperative time in various grafting indications, (2) this study verified the efficacy of a CPS putty bone graft biomaterial in a large array of implant-related surgical indications, and (3) implants placed in sites grafted with CPS putty yield very high survival rates.

  19. The Physician's Assistant in a Rural Satellite Clinic: Report on an Evaluative Case Study of Utilization, Acceptance and Economics.

    ERIC Educational Resources Information Center

    Hill, Robert; And Others

    In an effort to mitigate the maldistribution of U.S. physicians, a rural satellite clinic was established in 1973 to serve the 1,239 citizens of Yale, Oklahoma. The clinic was manned by a graduate of the two year Physician's Associate program at the University of Oklahoma who was under the supervision and employ of a pediatrician located 20 miles…

  20. Clinical evaluation of vocal fold paralysis.

    PubMed

    Richardson, Brent E; Bastian, Robert W

    2004-02-01

    Vocal fold paralysis is regarded as a sign of other pathologic findings until investigation has proven that there is no lesion to explain the paralysis. We have outlined a cost-effective and time- and labor-efficient method for the clinical evaluation of vocal fold paralysis, including a focused history; vocal capability assessment to find deficits in the function of palate,pharynx, and larynx: and, finally, an intense examination under topical anesthesia to demonstrate these deficits. In essence, it is the endoscopic version of a radiographic study from the skull base through the aortic arch. This method is streamlined as compared with prior protocols for evaluation of vocal fold paralysis, because it directs the necessary further workup according to the likely site of the lesion as indicated by the extended physical examination and can be conducted entirely in the physician's office. Radiographic workup should include CT of the skull base through the upper mediastinum if solely a recurrent nerve paralysis is present; it should include MRI of the skull base if high vagal signs and symptoms are present. If MRI is negative, CT may also be needed for complete evaluation. Neurologic signs that are not all ipsilateral require MRI of the brain and consultation with a neurologist. Esophageal obstruction combined with vocal fold paralysis mandates evaluation via esophagoscopy or an esophagram.

  1. Clinical evaluation of glass ceramic inlays (Dicor).

    PubMed

    Stenberg, R; Matsson, L

    1993-04-01

    The purpose of the study was to evaluate the clinical behavior of ceramic class-II inlays (Dicor) in the first 2 years after placement. As a reference, a similar number of dental amalgam restorations were followed up during the same period. Twenty-five inlays and 25 dental amalgams were placed on premolars and first molars of 20 and 19 patients (15-19 years old), respectively. The inlay preparations were made in accordance with the manufacturer's recommendations, and the inlays were produced by a licensed Dicor laboratory. The inlays were luted, using a glass ionomer cement. The dental amalgam preparations were made using standard class-II preparation techniques and filled with ANA 2000. The inlays were evaluated after 6, 12, and 24 months, and the dental amalgam restorations after 24 months, using the criteria suggested by Ryge. In addition, the 24-month examination included proximal recording of dental plaque and gingivitis. With the exception of two inlays that fractured during the observation period, all ceramic inlays showed excellent ratings for anatomic form, marginal discoloration, and marginal caries at all examinations. Two inlays showed minor marginal defects but were classified within the range of acceptance with no need for replacement. The two fractured inlays were replacements of earlier fractured dental amalgams. The clinical behavior of the dental amalgam restorations was in most respects similar to that of the ceramic inlays. Unlike the inlays, however, no dental amalgams fractured during the observation period.(ABSTRACT TRUNCATED AT 250 WORDS)

  2. Clinical Evaluation of Specific Oral Manifestations in Pediatric Patients with Ascertained versus Potential Coeliac Disease: A Cross-Sectional Study

    PubMed Central

    Matacena, Giada; Costa, Stefano; Magazzù, Giuseppe

    2014-01-01

    Patients involved on coeliac disease (CD) have atypical symptoms and often remain undiagnosed. Specific oral manifestations are effective risk indicators of CD and for this reason an early diagnosis with a consequent better prognosis can be performed by the dentist. There are not researches analysing the frequency of these oral manifestations in potential coeliac patients. The aim of this study is to investigate the oral hard and soft tissue lesions in potential and ascertained coeliac children in comparison with healthy controls. 50 ascertained children, 21 potential coeliac patients, and 54 controls were recruited and the oral examination was performed. The overall oral lesions were more frequently present in CD patients than in controls. The prevalence of oral soft tissue lesions was 62% in ascertained coeliac, 76.2% in potential coeliac patients, and 12.96% in controls (P < 0.05). Clinical dental delayed eruption was observed in 38% of the ascertained coeliac and 42.5% of the potential coeliac versus 11.11% of the controls (P < 0.05). The prevalence of specific enamel defects (SED) was 48% in ascertained coeliac and 19% in potential coeliac versus 0% in controls (P < 0.05; OR = 3.923). The SED seem to be genetically related to the histological damage and villous atrophy. PMID:25197270

  3. Clinical evaluation and serum concentration of zuclopenthixol acetate in psychotic Asian patients: a single-dose preliminary study.

    PubMed

    Tan, C H; Low, B L; Ng, L L; Khoo, Y M; Lee, H S

    1993-04-01

    Nineteen acutely disturbed psychotic Asian patients were treated with a single intramuscular injection of 50 mg of zuclopenthixol acetate in Viscoleo. Patients were assessed clinically before and after treatment using the Brief Psychiatric Rating Scale (BPRS). Serum zuclopenthixol and the inactive geometric isomer trans(E)-clopenthixol were determined by high-performance liquid chromatography after intramuscular injection. All patients improved, with the BPRS being significantly reduced (p < 0.001) at 72 h after injection. Adverse effects were generally few. The mean +/- SEM serum zuclopenthixol concentrations at 24, 48, and 72 h were 19.9 +/- 2.8, 31.5 +/- 4.5, and 17.8 +/- 2.9 micrograms/L, respectively. trans(E)-Clopenthixol concentrations ranged from negligible to 39.5 micrograms/L. This study confirms that a single intramuscular injection of 50 mg is adequate for managing severely disturbed psychotic patients for the first 3 days. The serum zuclopenthixol concentrations attained in the Asian patients were higher than those reported in Caucasian psychiatric patients. In some patients, a considerable amount of zuclopenthixol had been transformed to trans(E)-clopenthixol.

  4. A Clinical Evaluation System for Anesthesiology Residents.

    ERIC Educational Resources Information Center

    Viets, J. L.; Foster, Scot D.

    1988-01-01

    Baylor College of Medicine's system for evaluating the clinical progress of anesthesiology residents, developed in response to problems of standards, staff cooperation, and student dissatisfaction with evaluation, assesses resident progress in terms of performance levels based on case complexity and degree of staff intervention. (Author/MSE)

  5. Important factors in predicting mortality outcome from stroke: findings from the Anglia Stroke Clinical Network Evaluation Study

    PubMed Central

    O. Bachmann, Max; Loke, Yoon Kong; D. Musgrave, Stanley; Price, Gill M.; Hale, Rachel; Metcalf, Anthony Kneale; Turner, David A.; Day, Diana J.; A. Warburton, Elizabeth; Potter, John F.

    2017-01-01

    Abstract Background although variation in stroke service provision and outcomes have been previously investigated, it is less well known what service characteristics are associated with reduced short- and medium-term mortality. Methods data from a prospective multicentre study (2009–12) in eight acute regional NHS trusts with a catchment population of about 2.6 million were used to examine the prognostic value of patient-related factors and service characteristics on stroke mortality outcome at 7, 30 and 365 days post stroke, and time to death within 1 year. Results a total of 2,388 acute stroke patients (mean (standard deviation) 76.9 (12.7) years; 47.3% men, 87% ischaemic stroke) were included in the study. Among patients characteristics examined increasing age, haemorrhagic stroke, total anterior circulation stroke type, higher prestroke frailty, history of hypertension and ischaemic heart disease and admission hyperglycaemia predicted 1-year mortality. Additional inclusion of stroke service characteristics controlling for patient and service level characteristics showed varying prognostic impact of service characteristics on stroke mortality over the disease course during first year after stroke at different time points. The most consistent finding was the benefit of higher nursing levels; an increase in one trained nurses per 10 beds was associated with reductions in 30-day mortality of 11–28% (P < 0.0001) and in 1-year mortality of 8–12% (P < 0.001). Conclusions there appears to be consistent and robust evidence of direct clinical benefit on mortality up to 1 year after acute stroke of higher numbers of trained nursing staff over and above that of other recognised mortality risk factors. PMID:28181626

  6. Comparative evaluation of efficacy of self-ligating interactive bracket with conventional preadjusted bracket: A clinical study

    PubMed Central

    Jayachandran, Balajee; Padmanabhan, Ratna; Vijayalakshmi, Devaki; Padmanabhan, Janardhanam

    2016-01-01

    Aims and Objectives: This clinical study was conducted to compare the interactive self-ligating twin brackets and the standard double width brackets for their efficiency in Rate of Retraction. Materials and Methods: A total of 20 patients with Angle's class I or class II or class III dento-alveolar malocclusions between the age group of 18-25 years were selected. 10 patients in each group both males and females were randomly selected for the study. Ten patients were bonded using conventional brackets (Group I) the other ten patients were bonded using Interactive self-ligating brackets (Group II). The Rate of retraction was quantified using the scanned models. Pretreatment and post treatment models were taken and scanned to measure the amount of Incisor movement and Anchor loss. Results: (1) Interactive Self-ligating brackets showed significant Rate of retraction when compared with conventional brackets on right and left quadrant. (Group I 0.545 ± .205: Group II 0.827 ± .208 P = .013*) (Group I 0.598 ± .160: Group II 0.804 ± .268 P = .071) (2) Interactive self-ligating brackets when compared with conventional brackets had significant amount of incisor movement on right and left quadrant. (Group I 3.51 ± .548: Group II 4.38 ± .1.06 P = .047*) and (Group I 3.66 ± .899: Group II 4.67 ± 1.02 P = .047*) (3) Conventional brackets showed significant Amount of Anchor loss when compared with that of Interactive self-ligating brackets on right and left quadrant. (Group I .948 ± .392: Group II 0.501 ± .229 P = .013*). In the left side (Group I 0.861 ± .464: Group II 0.498 ± .227 P = .060). Conclusion: The interactive self-ligating brackets show more efficiency in Rate of Retraction, Amount of Incisor movement and Amount of Anchor loss when compared with the conventional brackets. PMID:27307660

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

    PubMed

    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.

  8. Clinical evaluation of terconazole. United states experience.

    PubMed

    Thomason, J L

    1989-08-01

    Terconazole is the first of a new class of antifungal agents, the triazoles. The results of numerous European studies have demonstrated the efficacy and safety of this agent in both cream and suppository form in the treatment of vulvovaginal candidiasis. Recently, results of short- and long-term analyses in the United States confirmed the efficacy and safety of 0.4% terconazole cream and 80-mg terconazole suppositories. In short-term evaluations (eight to ten days after therapy), 0.4% terconazole cream was as effective as 2.0% miconazole nitrate cream and significantly superior microbiologically in one study. The clinical cure rates with terconazole cream ranged from 87.3% to 95.5% and the microbiologic cure rates, from 76.9% to 91.1%. Thirty- to 35-day microbiologic relapse rates with terconazole cream ranged from 10.4% to 22.2%. In the short-term evaluations of vaginal suppositories the cure rates of 80-mg terconazole suppositories for three days were comparable to those of 100-mg miconazole nitrate suppositories for seven days. The clinical cure rates with 80-mg terconazole suppositories ranged from 90.0% to 92.2% and the microbiologic cure rates, from 80.4% to 85.0%. The 30- to 35-day microbiologic relapse rates of the 80-mg terconazole suppositories ranged from 20.0% to 28.1%. Terconazole cream and suppositories demonstrated an excellent safety profile in all the studies; no life-threatening side effects occurred with any of the regimens. The frequency of common side effects was similar with terconazole and miconazole nitrate formulations.

  9. Evaluation of Respiratory Muscle Strength in Mouth Breathers: Clinical Evidences

    PubMed Central

    Andrade da Cunha, Renata; Andrade da Cunha, Daniele; Assis, Roberta Borba; Bezerra, Luciana Ângelo; Justino da Silva, Hilton

    2013-01-01

    Introduction The child who chronically breathes through the mouth may develop a weakness of the respiratory muscles. Researchers and clinical are seeking for methods of instrumental evaluation to gather complementary data to clinical evaluations. With this in mind, it is important to evaluate breathing muscles in the child with Mouth Breathing. Objective To develop a review to investigate studies that used evaluation methods of respiratory muscle strength in mouth breathers. Data Synthesis  The authors were unanimous in relation to manovacuometry method as a way to evaluate respiratory pressures in Mouth Breathing children. Two of them performed with an analog manovacuometer and the other one, digital. The studies were not evaluated with regard to the method efficacy neither the used instruments. Conclusion There are few studies evaluating respiratory muscle strength in Mouth Breathing people through manovacuometry and the low methodological rigor of the analyzed studies hindered a reliable result to support or refuse the use of this technique. PMID:25992108

  10. A study of familial MELAS: evaluation of A3243G mutation, clinical phenotype, and magnetic resonance spectroscopy-monitored progression.

    PubMed

    Chen, Chunnuan; Xiong, Nian; Wang, Yuhui; Xiong, Jing; Huang, Jinsha; Zhang, Zhentao; Wang, Tao

    2012-01-01

    The clinical manifestations of mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes syndrome (MELAS syndrome) are nonspecific and can easily be misdiagnosed. Magnetic resonance spectroscopy (MRS)-based detection of lactate in the brain has been found to be of diagnostic help in MELAS syndrome, however, the issue of whether MRS features vary by stage remains unresolved. We assessed the causative mutation and radiological features of a family of MELAS. Four of the family members harbored the A3243G mutation, probably of maternal inheritance. However, the clinical phenotypic expression was different in these patients. MRS showed a lactate peak, decreased N-acetylaspartate, choline, and creatine, which became more pronounced with progression of the disease, demonstrating that brain-MRS-based detection of lactate may be a suitable way to monitor the progression and treatment of MELAS.

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

    PubMed Central

    Dhindsa, Abhishek; Pandit, I. K.; Srivastava, Nikhil; Gugnani, Neeraj

    2011-01-01

    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. PMID:22114450

  12. Clinical Studies with Epothilones

    NASA Astrophysics Data System (ADS)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

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

    PubMed Central

    2011-01-01

    Aim 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 (LLT) in FH patients recruited in SAFEHEART. Methods and Results A cross-sectional analysis of cases recruited in the Spanish FH cohort at inclusion was performed. Demographic, lifestyle, medical and therapeutic data were collected by specific surveys. Blood samples for lipid profile and DNA were obtained. Genetic test for FH was performed through DNA-microarray. Data from 1852 subjects (47.5% males) over 19 years old were analyzed: 1262 (68.1%, mean age 45.6 years) had genetic diagnosis of FH and 590 (31.9%, mean age 41.3 years) were non-FH. Cardiovascular disease was present in 14% of FH and in 3.2% of non-FH subjects (P < 0.001), and was significantly higher in patients carrying a null mutation compared with those carrying a defective mutation (14.87% vs. 10.6%, respectively, P < 0.05). Prevalence of current smokers was 28.4% in FH subjects. Most FH cases were receiving LLT (84%). Although 51.5% were receiving treatment expected to reduce LDL-c levels at least 50%, only 13.6% were on maximum statin dose combined with ezetimibe. Mean LDL-c level in treated FH cases was 186.5 mg/dl (SD: 65.6) and only 3.4% of patients reached and LDL-c under 100 mg/dl. The best predictor for LDL-c goal attainment was the use of combined therapy with statin and ezetimibe. Conclusion Although most of this high risk population is receiving LLT, prevalence of cardiovascular disease and LDL-c levels are still high and far from the optimum LDL-c therapeutic goal. However, LDL-c levels could be reduced by using more intensive LLT such as combined therapy with maximum statin dose and ezetimibe. PMID:21663647

  14. Clinical and histological evaluation of an analogue of palmitoylethanolamide, PLR 120 (comicronized Palmidrol INN) in cats with eosinophilic granuloma and eosinophilic plaque: a pilot study.

    PubMed

    Scarampella, F; Abramo, F; Noli, C

    2001-02-01

    Fifteen cats with eosinophilic granuloma or eosinophilic plaque were given PLR 120 at the dosage of 10 mg kg-1 twice daily for one month. PLR-120 down-modulates mast cell degranulation via a receptor-mediated mechanism. No other drugs were permitted and cats were kept free of parasites throughout the study. A clinical evaluation and skin biopsies were performed before and after the treatment. Clinical improvement was assessed at 15 and 30 days. Mast cell numbers were counted and their granular content was assessed by densitometric analysis on toluidine blue-stained sections before and after the treatment. Ten of 15 (67%) cats showed clinical improvement of signs and lesions. There was no significant difference between mast cell numbers in skin biopsies taken before and after the trial, whereas the number of granules was significantly increased (P < 0.009). This pilot study suggests that PLR-120 might be a useful drug for the treatment of eosinophilic granuloma and eosinophilic plaque.

  15. Recurrent PID, subsequent STI, and reproductive health outcomes: findings from the PID evaluation and clinical health (PEACH) study.

    PubMed

    Trent, Maria; Bass, Debra; Ness, Roberta B; Haggerty, Catherine

    2011-09-01

    PEACH trial data were used to evaluate the relationship between subsequent sexually transmitted infection and recurrent pelvic inflammatory disease on infertility and chronic pelvic pain (CPP). Recurrent pelvic inflammatory disease was associated with an almost 2-fold increase in infertility and more than 4-fold increase in CPP. Subsequent sexually transmitted infection was associated with CPP, but not infertility.

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

    PubMed Central

    Nagarjuna Reddy, Y. V.; Deepika, P. C.; Venkatesh, M. P.; Rajeshwari, K. G.

    2016-01-01

    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-month follow-up (P

  17. Clinical Evaluation of the Measurement Performance of the Philips Health Watch: A Within-Person Comparative Study

    PubMed Central

    2017-01-01

    Background Physical inactivity is an important modifiable risk factor for chronic diseases. A new wrist-worn heart rate and activity monitor has been developed for unobtrusive data collection to aid prevention and management of lifestyle-related chronic diseases by means of behavioral change programs. Objective The objective of the study was to evaluate the performance of total energy expenditure and resting heart rate measures of the Philips health watch. Secondary objectives included the assessment of accuracy of other output parameters of the monitor: heart rate, respiration rate at rest, step count, and activity type recognition. Methods A within-person comparative study was performed to assess the performance of the health watch against (medical) reference measures. Participants executed a protocol including 15 minutes of rest and various activities of daily life. A two one-sided tests approach was adopted for testing equivalence. In addition, error metrics such as mean error and mean absolute percentage error (MAPE) were calculated. Results A total of 29 participants (14 males; mean age 41.2, SD 14.4, years; mean weight 77.2, SD 10.2, kg; mean height 1.8, SD 0.1, m; mean body mass index 25.1, SD 3.1, kg/m2) completed the 81-minute protocol. Their mean resting heart rate in beats per minute (bpm) was 64 (SD 7.3). With a mean error of −10 (SD 38.9) kcal and a MAPE of 10% (SD 8.7%), total energy expenditure estimation of the health watch was found to be within the 15% predefined equivalence margin in reference to a portable indirect calorimeter. Resting heart rate determined during a 15-minute rest protocol was found to be within a 10% equivalence margin in reference to a wearable electrocardiogram (ECG) monitor, with a mean deviation of 0 bpm and a maximum deviation of 3 bpm. Heart rate was within 10 bpm and 10% of the ECG monitor reference for 93% of the duration of the protocol. Step count estimates were on average 21 counts lower than a waist-mounted step

  18. A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.

    PubMed

    Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton

    2012-08-01

    To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.

  19. Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

    PubMed

    Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial.

  20. Clinical Evaluation in a Family Medicine Residency.

    ERIC Educational Resources Information Center

    Herman, James M.; And Others

    1985-01-01

    A study assessed (1) the validity of the Bowman Gray School of Medicine evaluation instrument regarding the occurrence of halo effects and (2) possible relationships between the faculty's evaluations of the residents and the residents' cognitive knowledge and productivity. (MLW)

  1. Evaluation of the efficacy of 100% Type-I collagen membrane of bovine origin in the treatment of human gingival recession: A clinical study

    PubMed Central

    Soni, Nitin; Sikri, Poonam; Kapoor, Daljit; Soni, Bhavita Wadhwa; Jain, Rachna

    2014-01-01

    Background: Various treatment modalities have been devised for gingival recession, which is one of the most common signs of periodontal disease. The present study evaluates the efficacy of bioresorbable 100% type I collagen membrane of bovine origin in the treatment of human gingival recession. Materials and Methods: Twenty cases of Miller's class I or class II localized gingival recession defects on the facial surface were treated with 100% type I collagen membrane of bovine origin in conjunction with coronally positioned flap. Pre-operative and post-operative assessments were performed with respect to probing pocket depth, clinical attachment level and clinical recession at 12, 24 and 36 weeks. The data thus collected were analyzed statistically. Results: Statistically significant improvement based on Student's t test was found in all the three clinical parameters. Conclusion: Bioresorbable 100% type I collagen membrane of bovine origin has given inspiring results in the treatment of human gingival recession defects, thereby justifying the use of this material wherever indicated. PMID:25565742

  2. Evaluation of the effect of hydrogen peroxide as a mouthwash in comparison with chlorhexidine in chronic periodontitis patients: A clinical study

    PubMed Central

    Rashed, Hazem Tarek

    2016-01-01

    Aims and Objective: This study was conducted to evaluate the effect of hydrogen peroxide (H2O2) as a mouthwash in comparison with chlorhexidine (CHX) in chronic periodontitis patients. Materials and Methods: A total of 45 patients suffering from localized mild to moderate chronic periodontitis were chosen. The subjects were divided equally into three groups. Group A patients were treated only with scaling and root planning (SRP). Group B were treated with SRP in combination with 0.2% CHX gluconate mouthwash twice daily for 10 days. Group C were treated with SRP in combination with 1.5% H2O2 mouthwash twice daily for 10 days. Gingival index, plaque index, pocket depth, and clinical attachment level were recorded for patients of all groups on day 0 (Baseline), 15, 30, and 90, respectively. Statistical analysis was done using the Statistical Package for the Social Sciences version 22.0. Repeated measures analysis of variance was used to assess the differences in the abovementioned indices because of time and groups. Results: Both CHX gluconate and H2O2 mouthwashes significantly reduced the gingival index more than that observed in the control group, but similar to each other. There were no significant differences in the clinical attachment loss, plaque index, and pocket depth among the study groups, but improvement was seen within the CHX group participants. In participants with chronic periodontitis, SRP in combination with 0.2% CHX gluconate mouthwash was an effective treatment in reducing the gingival index and the pocket depth, as well as improving the clinical attachment level. Conclusion: The use of CHX gluconate was observed to be higher than H2O2 for the reduction in the gingival index and the pocket depth, as well as for the improvement of the clinical attachment level. PMID:27382535

  3. A comparative evaluation of topical and intrasulcular application of coenzyme Q10 (Perio Q™) gel in chronic periodontitis patients: A clinical study

    PubMed Central

    Sale, Srinivasa Tenka; Parvez, Humera; Yeltiwar, Ramreddy Krushna Rao; Vivekanandan, Gopinath; Pundir, Aena Jain; Jain, Priya

    2014-01-01

    Background and Objectives: Coenzyme Q10 is a well-studied antioxidant in the medical literature, but studies regarding its efficacy in periodontal diseases are few. coenzymeoenzyme Q10 serves as an endogenous antioxidant and its increased concentration in the diseased gingiva effectively suppresses advanced periodontal inflammation. The aim of this study is to evaluate the efficacy of coenzyme Q10 (Perio Q™) as an adjunct to scaling and root planing in patients with chronic periodontitis. Materials and Methods: A total of 18 patients were enrolled for the study. The selected subjects were treated in three different quadrants randomly. The control quadrant was treated by scaling and root planing only, while the other two test quadrants were treated by intra-pocket application of gel combined with scaling or root planing and topical applications combined with scaling and root planning, respectively. Clinical parameters such as plaque index, gingival index, gingival bleeding index and probing pocket depth were assessed at baseline and at the 2nd week and 4th weeks. The results were subjected to statistical analysis. Results: There was a significant improvement in all clinical parameters in the test sites seen at the end of the 4-week period. Sites with bleeding on probing were reduced more in the test group than in the control group. Conclusion: Coenzyme Q10 can be said to have a beneficial effect on periodontitis when used as an adjunct to scaling and root planing. PMID:25210260

  4. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study

    PubMed Central

    Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran

    2016-01-01

    Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58 ± 11 years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18 ± 0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent. PMID:27597929

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

    PubMed Central

    Narang, Isha; Mittal, Neelam; Mishra, Navin

    2015-01-01

    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. PMID:25684914

  6. Benign prostatic hyperplasia: clinical manifestations and evaluation.

    PubMed

    Santos Dias, José

    2012-12-01

    Benign prostatic hyperplasia (BPH) is a very common condition, related to aging and causing symptoms, called lower urinary tract symptoms. On account of its huge prevalence, it is important for clinicians who are involved in the management of patients with BPH to be aware of the very strict recommendations for BPH evaluation. In this article, we describe the different steps and procedures doctors should follow to evaluate these patients; symptoms and signs of BPH are reviewed, as well as the clinical evaluation steps and examinations available. The basic evaluation of the patients with BPH should include, according to the recommendations of the most relevant international guidelines, lower urinary tract symptoms evaluation with appropriate symptom scores, digital rectal examination, voiding charts, prostate-specific antigen and creatinine measurement, urinalysis, and imaging of the urinary tract.

  7. The evaluation of coagulation parameters and vessel involvement in Behcet' s disease. A clinical experience of Behcet' s disease: study of 152 cases.

    PubMed

    Harman, Ece; Sayarlıoglu, Mehmet; Harman, Mustafa; Sayarlıoglu, Hayriye

    2013-05-07

    Behcet´s disease (BD) is accepted as a systemic vasculitis. Vasculitis is observed  predominantly on the venous system. Vessel involvement is frequently seen in males. This study was planned retrospectively evaluate demographic features, clinical features, vessel involvements in BD. Furthermore, we aimed to prospectively compare consecutively chosen patients with and without thrombosis and healthy volunteers in terms of their biochemical, immunological, coagulation parameters. One hundred fifty-two Behcet´s patients were retrospectively evaluated. Blood samples were collected from 52 consecutively chosen patients and 41 healthy subjects. Papulopustular skin lesions, eye involvement and venous lesions were detected frequent in males. In terms of evaluated parameters (biochemical parameters, coagulation parameters, C-reactive protein, erythrocyte sedimentation rate, anticardiolipin antibodies, antinuclear antibody positivity) was not found a significant difference among groups (patients without thrombosis, healthy control subjects, patients with thrombosis). We detected statistically significant difference in terms of factor V levels between patient and control group. The tendency to thrombosis in patients with BD is well known. The endothelial lesion, increased procoagulant activity, hypofibrinolysis were found to be responsible from these events. In our study, there was no significant difference in terms of coagulation parameters between the patients without and with thrombosis.

  8. Evaluation of the Anti-Inflammatory Effect of Locally Delivered Vitamin C in the Treatment of Persistent Gingival Inflammation: Clinical and Histopathological Study

    PubMed Central

    Abdul Aziz, Manar A.; Abdel Rahman, Ahmed R.

    2016-01-01

    Objective. The purpose of this study is to investigate the role and efficiency of the locally injected vitamin C in the treatment of persistent gingival inflammation. Design. Twenty adult patients with persistent chronic gingival inflammation were included in this study. The same dose of sterile vitamin C was injected in gingival tissues after the completion of phase I therapy. Gingival biopsies were taken after total resolution of inflammation. The specimens were examined histologically, using H&E stain. Results. Clinical evaluation revealed great improvement of the injected sites with recall visits. Histopathological results revealed marked decrease in inflammatory cells and epithelial thickness and a higher number of newly formed subbasal capillaries. Conclusions. Vitamin C is an effective adjunctive treatment in reducing various degrees of chronic gingival inflammation. PMID:28050280

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

    PubMed Central

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

    2013-01-01

    Background: 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. Materials and Methods: 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. Results: 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). Conclusion: 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. PMID:24174757

  10. Instructional Scaffolding to Improve Students’ Skills in Evaluating Clinical Literature

    PubMed Central

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

    2011-01-01

    Objective 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. Design 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). Assessment 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. Conclusion 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. PMID:21769138

  11. [Clinical research III. The causality studies].

    PubMed

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  12. The clinical efficacy of Diphoterine® in the management of cutaneous chemical burns: a 2-year evaluation study.

    PubMed

    Zack-Williams, S D L; Ahmad, Z; Moiemen, N S

    2015-03-31

    Diphoterine(®) is an amphoteric irrigating agent for the treatment of chemical burns and rapidly neutralises both acids and alkalis faster than water alone. Diphoterine(®) is widely used as a first aid agent in a wide range of industries globally. This is a retrospective review of the clinical use of Diphoterine(®) on chemical burns in an adult tertiary referral burn centre, often with a delay of several hours after the injury. patients admitted with chemical burns within 24 hours of the incident with an abnormal wound pH or in pain, were treated with Diphoterine(®) spray. Over a 32-month period, 1,875 burn referrals were admitted of which 131 (7%) were chemical burns. Diphoterine(®) was used in 47 patients (36%). The male to female ratio for the 131 patients was 4:1. Alkaline burns were the commonest (55%). patients who received Diphoterine(®) were significantly younger (38 vs 43 years; p=0.05) and presented earlier (0.5 vs 2.55 days; p=0.004). There was a significant change in the wound pH pre- and post-application of Diphoterine(®), compared to patients who were treated with water irrigation only, with a pH change of 1.076 vs 0.4 (p <0.05). There was no significant difference in the time to healing, the length of hospital stay, or need for surgery. in conclusion, based on our retrospective cohort, Diphoterine(®) could be a valuable tool for use in hospital settings to neutralise both alkaline and acid burns.

  13. [Clinical evaluation of oxypertine in anxiety conditions].

    PubMed

    Somohano, M D; Broissin, M C; Sobrino Z, A

    1976-01-01

    Oxypertine, a new anxiolytic drug related to the indolylazine compounds, was evaluated in a group of 30 patients, the majority with severe anxiety (acute or chronic) : in some cases depression was associated. The study was performed in the Psychiatric Department at the Centro Femenil de Rehabilitación Social, in Mexico City. A special feature of this study was that patients were confined for a legal process and consequently with restricted liberty. All were females between 19 to 44 years old, with an average age of 32.05 years. The methodology applied in this case was a modified double blind randomized procedure, using different color capsules with placebo or the active drug (yellow oxypertine and blue placebo). Patients received a 10 mg capsule every 12 hours (20 mg daily). The clinical measurement of anxiety was performed using the Visual Anxiety Scale (Murphy), evaluating each of its 11 parameters. The intensity was qualified from 0 to 3; at the end of each consultation a global assessment was made. Most of the patients were interviewed in five occasions during the treatment period. For each of the nine patients receiving during 4 weeks only oxypertine capsules (group I), the scores of the parameters of the scale were added, observing the following results: in seven excellent respond, fair in one and one abandoned the study since the beginning. In eight of the patients who received placebo (group II) also for a 4 weeks period, results were evaluated as follows: five excellent one good and two poor. It can be observed that both groups gave a similar final score at the end of the study, meaning that no significant benefits were obtained between the active drug and the placebo, in spite that anxiety decreased in most of them. In group III, seven cases initiated with placebo and after 2 weeks the capsule had to be changed to oxypertine due to stablization or increase in the anxiety. Results were excellent in three, good in two, poor in one and another case

  14. Strategies for inhibitor treatment and costs in the short and long term: a critical evaluation of recent clinical studies.

    PubMed

    Baghaipour, Mohammad Reza; Steen Carlsson, Katarina

    2015-02-01

    One important complication of patients with severe haemophilia A is the formation of inhibitory antibodies to factor VIII (FVIII). Immune tolerance induction (ITI) is the treatment of choice for patients with inhibitors, but this approach is successful in about 60% of patients. Treatment of acute bleeding in patients with inhibitors is one of the greatest challenges in haemophilia management and is costly. Bypassing agents are the mainstay of treatment in these patients. The aims of this study were to review the most recent publications concerning the costs of inhibitor treatment. We conducted a literature review using PubMed which yielded 63 papers analysing the costs of inhibitor management of which 12 were suitable for our study. Four of eight studies supported the use of activated prothrombin complex concentrate (aPCC) with lower costs, but the remaining four studies showed that recombinant factor VIIa (rFVIIa) had a lower average treatment cost. Of four ITI studies, two supported lifelong cost-effectiveness of ITI vs. bypassing agents and the remaining two papers showed a high cost of inhibitor treatment. Dosages, time between onset of bleeding and treatment, patient characteristics and the price of drugs are some of the important issues that should be considered for further studies.

  15. Evaluation of different systems for clinical quantification of varicose veins.

    PubMed

    Cornu-Thénard, A; De Vincenzi, I; Maraval, M

    1991-04-01

    One hundred twenty-five lower limbs with varicose veins were studied clinically, essentially by palpation. Two specialists in venous pathology scored the severity of the varicose veins from 0 to 20. Comparison between the different clinical parameters and the scores of the specialists showed that two systems of clinical quantification gave good results and were easy to use. One system is the maximum diameter of the largest varicose vein; the other system is the sum of maximum diameters over 7 sections (3 for thigh, 3 for leg, 1 for foot). This latter system gives a more precise evaluation of the clinical severity of the varicose veins.

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

    PubMed

    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 (p<0.05). Patients in the control group had received

  17. Evaluating clinical dermatology practice in medical undergraduates.

    PubMed

    Casanova, J M; Sanmartín, V; Martí, R M; Morales, J L; Soler, J; Purroy, F; Pujol, R

    2014-06-01

    The acquisition of competences (the set of knowledge, skills and attitudes required to perform a job to a professional level) is considered a fundamental part of medical training. Dermatology competences should include, in addition to effective clinical interviewing and detailed descriptions of skin lesions, appropriate management (diagnosis, differentiation, and treatment) of common skin disorders and tumors. Such competences can only be acquired during hospital clerkships. As a way of certifying these competences, we propose evaluating the different components as follows: knowledge, via clinical examinations or critical incident discussions; communication and certain instrumental skills, via structured workplace observation and scoring using a set of indicators; and attitudes, via joint evaluation by staff familiar with the student.

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

    PubMed

    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.

  19. Ultrareliable PACS: design and clinical evaluation

    NASA Astrophysics Data System (ADS)

    Goble, John C.; Kronander, Torbjorn; Wilske, Nils-Olof; Yngvesson, Jonas T.; Ejderholm, Henrik; Ekstrom, Marie

    1999-07-01

    We describe our experience in the design, installation and clinical evaluation o fan ultra-reliable PACS - a system in which the fundamental design constraint was system availability. This syste has ben constructed using commercial, off-the-shelf hardware and software, using an open system, standards-based approach. The system is deployed in the film-free Department of Pediatric Radiology at the Astrid Lindgren Barnsjukhus a nit of the Karolinska Institute in Stockholm, Sweden.

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

    PubMed Central

    2013-01-01

    Background 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. Methods 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. Result 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. Conclusions 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. Virtual slide The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1107407136102196 PMID:23866960

  1. A Correlative Classification Study of Schizophrenic Patients with Results of Clinical Evaluation and Structural Magnetic Resonance Images

    PubMed Central

    Chu, Wen-Lin; Jian, Bo-Lin; Hsu, Chih-Yao

    2016-01-01

    Patients with schizophrenia suffer from symptoms such as hallucination and delusion. There are currently a number of publications that discuss the treatment, diagnosis, prognosis, and damage in schizophrenia. This study utilized joint independent component analysis to process the images of GMV and WMV and incorporated the Wisconsin card sorting test (WCST) and the positive and negative syndrome scale (PANSS) to examine the correlation of obtained brain characteristics. We also used PANSS score to classify schizophrenic patients into acute and subacute cases, to analyze the brain structure differences. Finally, we used brain structure images and the error rate of the WCST as eigenvalues in support vector machine learning and classification. The results of this study showed that the frontal and temporal lobes of a normal brain are more apparent than those of a schizophrenia brain. The highest level of classification recognition reached 91.575%, indicating that the WCST error rate and characteristic changes in brain structure volume can be used to effectively distinguish schizophrenia and normal brains. Similarly, this result confirmed that the WCST and brain structure volume are correlated with the differences between schizophrenia and normal participants. PMID:27843197

  2. Clinical evaluation of the electronic nose in the diagnosis of ear, nose and throat infection: a preliminary study.

    PubMed

    Shykhon, M E; Morgan, D W; Dutta, R; Hines, E L; Gardner, J W

    2004-09-01

    The term electronic nose describes an electronic system that is able to mimic the human sense of smell. Electronic noses have been developed over the last 10 or more years to perform a variety of identification tasks in various industries. More recently electronic noses have attracted new interest in their application in the field of medical diagnosis. The aim of this study is to explore the use of an electronic nose to identify and classify pathogens associated with ear, nose and throat (ENT) infections. In this study 90 bacterial swab samples were collected from 90 patients with ENT infections. Some of these samples were analysed immediately with a commercial electronic nose (Cyranose C320). Similar numbers of swabs were also taken from the same site of infection and were sent for microbiology culture and sensitivity. The electronic nose diagnosis was compared with the microbiology diagnosis and it was found that the electronic nose diagnosis was correct in 88.2 per cent of the cases, which is an encouraging result.

  3. Radiographic Evaluation of Crestal Bone Loss Around Dental Implants in Maxilla and Mandible: One Year Prospective Clinical Study

    PubMed Central

    Ajanović, Muhamed; Hamzić, Adis; Redžepagić, Sead; Kamber-Ćesir, Alma; Tosum, Selma

    2015-01-01

    Purpose The aim of the study was to analyze the amount of maxillary and mandibular crestal bone loss around Bredent Sky Blue type of implants of different dimensions one year after implantation. Materials and Methods 36 implants of diameter 3.5 x 10 mm were inserted in the maxilla and 12 in the mandible. 52 implants of diameter 4.0 x 8 mm were inserted in the maxilla, and 61 in the mandible (two-stage implant surgery). Results No statistically significant differences were found between the right and left side of the maxilla and between the right and left side of the mandible at the implant sites regarding distal and mesial bone losses as shown by analysis of variance (ANOVA). Conclusion Statistically significant differences were found between anterior maxilla, posterior maxilla and anterior mandible and posterior mandible at implant sites regarding distal and mesial bone losses as shown by analysis of variance (ANOVA). PMID:27688395

  4. [Evaluation of the safety of antitussive agents during respiratory rehabilitation. A clinical study of L-dropropizine].

    PubMed

    Bejor, M; Arrigo, A

    1990-06-30

    This study proves that L-dropropizine, a new peripheral antitussive drug, does not hinder the positive and useful effect of cough. This is particularly the case of physiokinesis in chronic obstructive lung disease patients. To quantify results, the respiratory voluntary muscles have been examined by surface electromyography and the peak expiratory flow has been registered by a computer-assisted device. By analysing the curves obtained relating the intensity of muscle contraction to expiratory flow, i.e. the muscle work exerted, no difference has been found after L-dropropizine and placebo. Statistical analysis evidenced increase in maximal peak expiratory flow and decrease in muscle work with both therapies. Both were significant (Student's test for paired data: p less than 0.01) in attaining functional improvement. Levodropropizine does not seem to impair the efficacy of cough elicited as part of respiratory clearance mechanisms.

  5. EARLIER: an observational study to evaluate the use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism in daily clinical practice.

    PubMed

    Hemetsberger, Margit; Oberbauer, Rainer; Erb, Helmut; Pronai, Wolfgang

    2015-10-01

    The EARLIER (Evaluation of MimpARa in incident hemodiaLysis patIEnts with secondaRy hyperparathyroidism; SHPT) observational postmarketing surveillance study evaluated incident hemodialysis patients (< 1 year dialysis vintage; n = 146) receiving cinacalcet in Austrian clinical practice. Despite intervention with vitamin D sterols and phosphate binders, 24 % had already developed severe SHPT (intact parathyroid hormone (iPTH) > 800 pg/mL) at baseline. After cinacalcet was started, median iPTH decreased substantially, from 611 pg/mL to 251 pg/mL (median decrease 58 % [IQR - 36 to - 78 %] at 12 months. Overall, 36 % of patients achieved the Kidney Disease Outcomes Quality Initiative (K/DOQI) target range (150-300 pg/mL) for iPTH; this included 35 % of those with severe SHPT at baseline. Serum phosphorus (P), calcium (Ca) (corr), and Ca (corr) × P also decreased, with 43, 34, and 62 % of patients, respectively, reaching K/DOQI targets at 12 months. Thus, in this observational study, mineral metabolism in incident dialysis patients with SHPT improved after starting cinacalcet.

  6. Clinical competency evaluation of Brazilian chiropractic interns

    PubMed Central

    Facchinato, Ana Paula A.; Benedicto, Camila C.; Mora, Aline G.; Cabral, Dayane M.C.; Fagundes, Djalma J.

    2015-01-01

    Objective This study compares the results of an objective structured clinical examination (OSCE) between 2 groups of students before an internship and after 6 months of clinical practice in an internship. Methods Seventy-two students participated, with 36 students in each cohort. The OSCEs were performed in the simulation laboratory before the participants' clinical practice internship and after 6 months of the internship. Students were tested in 9 stations for clinical skills and knowledge. The same procedures were repeated for both cohorts. The t test was used for unpaired parametric samples and Fisher's exact test was used for comparison of proportions. Results There was no difference in the mean final score between the 2 groups (p = .34 for test 1; p = .08 for test 2). The performance of the students in group 1 was not significantly different when performed before and after 6 months of clinical practice, but in group 2 there was a significant decrease in the average score after 6 months of clinical practice. Conclusions There was no difference in the cumulative average score for the 2 groups before and after 6 months of clinical practice in the internship. There were differences within the cohorts, however, with a significant decrease in the average score in group 2. Issues pertaining to test standardization and student motivation for test 2 may have influenced the scores. PMID:25588200

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

    PubMed

    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 (p<0.001) in dogs with heartworm or cardiomyopathy compared with concentrations in controls. In the heartworm group, CRP was significantly increased (p<0.001) in dogs with mild or severe pulmonary hypertension but not in dogs with low or high parasite burden without pulmonary hypertension. Heartworm

  8. A Sense of Urgency: Evaluating the Link between Clinical Trial Development Time and the Accrual Performance of CTEP-Sponsored Studies

    PubMed Central

    Cheng, Steven K.; Dietrich, Mary S.; Finnigan, Shanda; Dilts, David M.

    2010-01-01

    Purpose Post-activation 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. Experimental Design National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, non-pediatric Phase I, I/II, II, and III studies activated between 2000–2004 were investigated for an eight-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, controlling for study phase and size of expected accruals. Results 37.9 percent (n=221) of CTEP-approved oncology trials failed to attain the minimum accrual goals, with 70.8 percent (n=14) of Phase III trials resulting in poor accrual. A total of 16474 patients (42.5% of accruals) accrued to those studies that were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months development were significantly more likely to achieve accrual goals (odds ratio, 2.15; 95% CI, 1.29–3.57, P=0.003) than trials with the median development time of 12–18 months. Trials requiring a development time of greater than 24 months were significantly less likely of achieving accrual goals (odds ratio, 0.40; 95% CI, 0.20–0.78, P=0.011) than trials with the median development time. Conclusions 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. PMID:21062929

  9. Evaluation of the illumigene C. difficile assay for toxigenic Clostridium difficile detection: a prospective study of 302 consecutive clinical fecal samples.

    PubMed

    Hong, Geehay; Park, Kyung Sun; Ki, Chang-Seok; Lee, Nam Yong

    2014-11-01

    Toxigenic Clostridium difficile is a major pathogen causing nosocomial diarrhea. Consequently, rapid detection of toxigenic C. difficile is very important in clinical laboratories. The illumigene C. difficile DNA amplification assay (illumigene; Meridian Bioscience, Inc.) is a rapid method that detects the toxin A gene (tcdA) by loop-mediated isothermal amplification. In the present study, we evaluated the diagnostic performance of the illumigene assay using 302 consecutive stool specimens in comparison with the VIDAS C. difficile A&B enzyme-linked fluorescent immunoassay (VIDAS-CDAB; bioMérieux). Toxigenic culture was used as the reference method. The sensitivity, specificity, positive predictive value, and negative predictive value of the illumigene assay were 88.1%, 96.7%, 86.7%, and 97.1%, respectively, while those of the VIDAS-CDAB assay were 40.4%, 98.8%, 87.5%, and 88.5%, respectively. It is of note that use of a combination of the illumigene and VIDAS-CDAB assays did not improve any of the 4 evaluated parameters (88.1%, 95.5%, 82.5%, and 97.1%, respectively). The illumigene assay showed limits of detection of 250 and 11,467 CFU/mL for ATCC 9688 (tcdA+, tcdB+, cdtB-) and ATCC 43598 (tcdA-, tcdB+, cdtB-) reference strains, respectively, and there was no cross-reactivity with 8 frequently isolated bacterial species. In conclusion, the illumigene assay might be a useful method for rapid detection of toxigenic C. difficile in clinical laboratories. Additionally, the VIDAS-CDAB assay seems unnecessary if the illumigene assay is used.

  10. Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study)

    PubMed Central

    Fink, Christine; Hofmann, Maja; Jagoda, Agata; Spaenkuch, Iris; Forschner, Andrea; Tampouri, Ioanna; Lomberg, Diana; Leupold, Dieter; Garbe, Claus; Haenssle, Holger A

    2016-01-01

    Introduction Non-invasive, nanosecond, stepwise two-photon laser excitation of skin tissue was shown to induce melanin fluorescence spectra that allow for the differentiation of melanocytic nevi from cutaneous melanoma. Methods and analysis This prospective, non-controlled, multicentre clinical study is performed to evaluate the diagnostic performance of the stepwise two-photon excited melanin fluorescence in the detection of cutaneous melanoma. The comparator will be the histopathological diagnosis. A total of 620 pigmented skin lesions suspicious for melanoma and intended for excision will be enrolled. Ethics and dissemination Ethics approval was provided by the local ethics committees of the medical faculties of the University of Tuebingen, Heidelberg and Berlin. Study registration The FLIMMA study NCT02425475. PMID:27993903

  11. Children and Clinical Studies: Why Clinical Studies Are Important

    MedlinePlus Videos and Cool Tools

    ... Clinical Studies Children have often had to accept medicines and treatments based on what is known to ... children's health with the goal to develop treatments, drugs, and devices specific to children. Resources for a ...

  12. Learn about Clinical Studies

    MedlinePlus

    ... is to make sure that the study is ethical and that the rights and welfare of participants ... trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  13. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    PubMed Central

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

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

    PubMed Central

    Nayak, Ranganath N.; Dixitraj, P. T.; Nayak, Aarati; Bhat, Kishore

    2015-01-01

    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. PMID:26604581

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

    PubMed

    Pavlidis, Mitrofanis

    2016-01-01

    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.

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

    PubMed Central

    2016-01-01

    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. PMID:27190635

  17. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

    PubMed Central

    2013-01-01

    Background Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing. The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity. Methods/Design The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the

  18. Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

    PubMed Central

    Viala-Danten, Muriel; Martin, Susan; Guillemin, Isabelle; Hays, Ron D

    2008-01-01

    Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Methods Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights. Results Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and

  19. Comparative evaluation of co-enzyme Q10 and Melaleuca alternifolia as antioxidant gels in treatment of chronic periodontitis: A clinical study

    PubMed Central

    Raut, Chetan Purushottam; Sethi, Kunal S.

    2016-01-01

    Background: Conventional nonsurgical periodontal therapy has been proven to be an effective treatment for patients with chronic periodontitis. Coenzyme Q10 and tea tree oil (TTO) are known to have potential therapeutic benefits in chronic periodontitis. Aims: The aim of the study is to compare the efficacy of Coenzyme Q10 (Perio Q®) and tea tree oil (Melaleuca alternifolia) gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. Materials and Methods: Patients were divided equally into three groups: Group I (Control group): those receiving placebo gel + SRP, Group II (Test group I): those receiving Perio QTM gel + SRP, and Group III (Test group II): those receiving tea tree oil gel + SRP. A total of 15 patients with 45 sites were enrolled in the study. Clinical parameters evaluated were plaque index (PI), gingival bleeding index (GI), probing pocket depth (PPD), and clinical attachment level (CAL). Statistical Analysis Used: Paired t-test was applied using SPSS software. Results: Mean PPD reduction for Group I, Group II, and Group III was 0.50 ± 0.2, 2.95 ± 0.20, and 2.09 ± 0.15, respectively. Mean CAL reduction for Group I, Group II, and Group III was 0.45 ± 0.22, 2.33 ± 0.04, and 2.28 ± 0.09, respectively. Changes in mean PI scores for Group I, Group II, and Group III were 0.67 ± 017, 1.00 ± 0.11, and 1.08 ± 0.05 and GBI scores were 0.92 ± 0.29, 1.08 ± 0.13, and 0.88 ± 0.28, respectively. Conclusions: Coenzyme Q10 and tea tree oil gel proved to be effective in the treatment of chronic periodontitis. PMID:27630504

  20. Evaluation of clinical thermometers for accuracy and reliability.

    PubMed

    Latman, N S; Hans, P; Nicholson, L; DeLee Zint, S; Lewis, K; Shirey, A

    2001-01-01

    The purpose of this study was to examine the accuracy and reliability of a wide range of clinical thermometry instruments and technologies. In a historical sense, the purpose of this study was to determine if the improvements in speed, ease of use, and safety realized in the last 100 years have been offset by a loss of accuracy and/or reliability. In view of current events, the purpose was to determine if the new generation of electronic, digital clinical thermometers could be used to replace the traditional glass/mercury thermometers. Nine clinical thermometers representing electronic, digital oral, and predictive oral; electronic, digital infrared tympanic; and liquid crystal urinary technologies were evaluated. Accuracy was determined by comparing the temperatures obtained from these test instruments with those of the reference, glass/mercury oral thermometer. Reliability was determined by test-retest evaluation. All of the thermometers evaluated were significantly less accurate when compared with the reference thermometer in this study. All of the test instruments significantly underestimated higher temperatures and overestimated lower temperatures. This study indicated that the improvements in safety, speed, and ease of use of the newer clinical thermometers have been offset by a loss in accuracy and reliability. It also indicated that the current generation of electronic, digital clinical thermometers, in general, may not be sufficiently accurate or reliable to replace the traditional glass/mercury thermometers.

  1. Clinical Study on the Management of Huzaz/Abria (Dandruff) with a pharmacopoeal Preparation of a Unani Medicine and its Cosmetic Evaluation

    PubMed Central

    Shah, Altaf Hussain; Haji, Amanullah; Rather, Shameem Ahmad; Ahmad, Tanzeel; Ansari, Abdul Nasir; Soff, G

    2009-01-01

    Dandruff called Huzaz/Abria in Unani medicine is a common ailment in the world with easy options of treatment. Most of the treatment options have ignored the cosmetic aspect of hair. Unani medicine has got a vast array of drug formulation to evaluate the efficacy of Unani pharmacopoeal formulation in mild form of seborrhic dermatitis of scalp (dandruff). Its efficacy was compared with standard drug (2% ketakonazole shampoo). Patients were enrolled after ethical clearance and informed consent in the study. 30 patients were treated with Unani formulation and 20 patients with the standard drug. The assessment of various parameters like Itching, Scalp shedding, Erythema, Hair frizz, Hair combing ease, and Hair smoothness was made before and after 30 days. The assessments of the parameters were analyzed and compared using appropriate statistical tests. The study revealed that Unani formulation was equally effective as standard drug and the hair comesis was better than the standard drug as seen clinically, but was not statistically significant (p=0.576). PMID:22557347

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

    PubMed

    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.

  3. [Evaluation of temporo-mandibular myoarthropathies, the status of the masticatory system and patients' personality based on the tests and clinical studies].

    PubMed

    Czajkowska, E

    1992-01-01

    Resorting to commonly applied methods and clinical indices, the masticatory organ state was evaluated in 64 patients with symptoms of myoarthropathy (studied group)) and in 61 patients without the symptoms of the disease (control group). The assumption laid down in the work was that the studied group and the control one do differ with regard to the incidence rate and the intensity of the investigated local parameters and the level of neuroticism as well as extraversion. The aim of the paper was to show the mutual correlation between the parameters studied, and to determine their effect on the inception of the temporal jaw dysfunction. It has been revealed that the advancement of age is accompanied by statistically significant increase in the incidence rate and intensity of local diseases as well as by malfunctions, a rise in the level of neuroticism and a drop of the extraversion level. In consequence of the former findings, severe forms of dysfunction of the mandibular articulation arose in 89% of patients within the highest age group. Comparing the parameters between the studied group and the controls provided the possibility to isolate the features that make the both groups differ, thus facilitating the determination of the influence the individual factors exert on the origination of dysfunction of the mandibular articulation. The most essential differences affected five factors: unilateral mode of mastication, parafunction, teeth deficit, abnormal occlusion and high neuroticism. The lack of statistically significant differences between the studied and control groups with respect to periodontal diseases, looseness of teeth, dental abrasion do not authorize us to exclude their influence on the formation of temporal jaw myoarthropathy, since these factors are responsible for the loss of teeth, occlusal articulation disorders, and in an indirect way they, undoubtedly, exert destructive influence on the organ of mastication.

  4. Clinical simulation: A method for development and evaluation of clinical information systems.

    PubMed

    Jensen, Sanne; Kushniruk, Andre W; Nøhr, Christian

    2015-04-01

    Use of clinical simulation in the design and evaluation of eHealth systems and applications has increased during the last decade. This paper describes a methodological approach for using clinical simulations in the design and evaluation of clinical information systems. The method is based on experiences from more than 20 clinical simulation studies conducted at the ITX-lab in the Capital Region of Denmark during the last 5 years. A ten-step approach to conducting simulations is presented in this paper. To illustrate the approach, a clinical simulation study concerning implementation of Digital Clinical Practice Guidelines in a prototype planning and coordination module is presented. In the case study potential benefits were assessed in a full-scale simulation test including 18 health care professionals. The results showed that health care professionals can benefit from such a module. Unintended consequences concerning terminology and changes in the division of responsibility amongst healthcare professionals were also identified, and questions were raised concerning future workflow across sector borders. Furthermore unexpected new possible benefits concerning improved communication, content of information in discharge letters and quality management emerged during the testing. In addition new potential groups of users were identified. The case study is used to demonstrate the potential of using the clinical simulation approach described in the paper.

  5. Accreditation Stimuli and Evaluation Responses in a Clinical Training Program.

    ERIC Educational Resources Information Center

    Wood, David; And Others

    Assessment and evaluation skills are significant goals of clinical training, yet many clinical and counseling students lack personal experiences with applied program evaluation. Clinical psychology graduate students responded to successive impending accreditation visits by conducting in-house evaluations. Students in 1977 (N=38) and 1980 (N=35)…

  6. Home Start Evaluation Study.

    ERIC Educational Resources Information Center

    High/Scope Educational Research Foundation, Ypsilanti, MI.

    Case studies of eight Home Start programs are given as the third section of an evaluation study. Communities involved are Binghamton, New York; Franklin, North Carolina; Cleveland, Ohio; Harrogate, Tennessee; Houston, Texas; Weslaco, Texas; Millville, Utah; Parkersburg, West Virginia. Although each study varies in format, each describes in detail…

  7. Epidemiological, clinical and sleep laboratory evaluations of insomnia

    NASA Technical Reports Server (NTRS)

    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.

  8. Prevalence of Anaemia and Evaluation of Transferrin Receptor (sTfR) in the Diagnosis of Iron Deficiency in the Hospitalized Elderly Patients: Anaemia Clinical Studies in Chile.

    PubMed

    López-Sierra, Mauricio; Calderón, Susana; Gómez, Jorge; Pilleux, Lilian

    2012-01-01

    Iron constitutes the most prevalent nutritional deficiency worldwide. In Chile, anaemia epidemiological data is scarce, evaluating mainly children and women. Our objective was to determine prevalence of anaemia in an inpatient elderly population (≥60 years) and assess the usefulness of sTfR levels analyzed by other authors as a good predictor in the differential diagnosis of iron deficiency anaemia and anaemia of chronic disease. Method. We studied medical patients admitted at Hospital of Valdivia (HV), Chile, in a 2month period. World Health Organization criteria were used for anaemia. Results. 391 patients were hospitalized, average age 62.5 years, 247 elderly and 99 of which had anaemia. Anaemia was normocytic in 88.8%, and we observed: low serum iron in 46.3%, low ferritin 10.1%, high TIBC 2%, low % transferrin saturation (Tsat) 40%, and high sTfR 25%. Conclusions. As a first figure known in Chile, the prevalence of anaemia in the elderly inpatient was 40.1%. Our findings encourage us to promote the implementation of sTfR determination in the clinical setting to analyze the state of erythropoiesis in patients with chronic diseases wich commonly occurs in elderly.

  9. Developing the Translational Research Workforce: A Pilot Study of Common Metrics for Evaluating the Clinical and Translational Award KL2 Program

    PubMed Central

    Schneider, Margaret; Guerrero, Lourdes; Jones, Lisa B.; Tong, Greg; Ireland, Christine; Dumbauld, Jill; Rainwater, Julie

    2015-01-01

    Purpose This pilot study describes the career development programs (i.e., NIH KL2 awards) across five Clinical and Translational Science Award (CTSA) institutions within the University of California (UC) system, and examines the feasibility of a set of common metrics for evaluating early outcomes. Methods A survey of program administrators provided data related to the institutional environment within which each KL2 program was implemented. Application and progress report data yielded a combined data set that characterized KL2 awardees, their initial productivity, and early career outcomes. Results The pilot project demonstrated the feasibility of aggregating common metrics data across multiple institutions. The data indicated that KL2 awardees were an accomplished set of investigators, both before and after the award period, representing a wide variety of disciplines. Awardees that had completed their trainee period overwhelmingly remained active in translational research conducted within an academic setting. Early indications also suggest high rates of success with obtaining research funding subsequent to the KL2 award. Conclusion This project offers a model for how to collect and analyze common metrics related to the education and training function of the CTSA Consortium. Next steps call for expanding participation to other CTSA sites outside of the University of California system. PMID:26602332

  10. Comparative Evaluation of the Effects of Nd:YAG Laser and a Desensitizer Agent on the Treatment of Dentin Hypersensitivity: A Clinical Study

    PubMed Central

    Lopes, Anely Oliveira

    2013-01-01

    Abstract Objective: The aim of this randomized longitudinal clinical study was to assess different treatment protocols for dentin hypersensitivity with high-power laser, desensitizing agent, and its association between high-power laser and desensitizing agent, for a period of 6 months. Background data: The literature shows a lack of treatment for dentin hypersensitivity, and lasers are contemporary alternatives. Methods: After inclusion and exclusion analysis, volunteers were selected. The lesions were divided into three groups (n=10): G1, Gluma Desensitizer (Heraeus Kulzer); G2, Nd:YAG Laser (Power Laser™ ST6, Lares Research®) contact mode, laser protocol of 1.5 W, 10 Hz, and 100 mJ,≈85 J/cm2, four irradiations performed, each for 15 sec, in mesiodistal and occluso-apical directions, totaling 60 sec of irradiation with intervals of 10 sec between them; G3, Nd:YAG Laser+Gluma Desensitizer. The level of sensitivity to pain of each volunteer was analyzed by visual analog scale (VAS) using cold air stimuli and exploratory probe 5 min, 1 week, and 1, 3, and 6 months after treatment. Data were collected and subjected to statistical analysis that detected statistically significant differences between the various studied time intervals of treatments (p>0.05). Results: For the air stimulus, no significant differences were found for each time interval. For the long-term evaluation, all groups showed statistical differences (p>0.05), indicating that for G2 and G3, this difference was statistically significant from the first time of evaluation (post 1), whereas in G1, the difference was significant from the post 2 evaluation (1 week). Comparison among groups using the probe stimulation showed significant differences in pain (p<0.001). Only in G1 and G3 did this difference become significant from post 01. Conclusions: All protocols were effective in reducing dentinal hypersensitivity after 6 months of treatment; however, the association of Nd:YAG and Gluma

  11. A call for change: clinical evaluation of student registered nurse anesthetists.

    PubMed

    Collins, Shawn; Callahan, Margaret Faut

    2014-02-01

    The ability to integrate theory with practice is integral to a student's success. A common reason for attrition from a nurse anesthesia program is clinical issues. To document clinical competence, students are evaluated using various tools. For use of a clinical evaluation tool as possible evidence for a student's dismissal, an important psychometric property to ensure is instrument validity. Clinical evaluation instruments of nurse anesthesia programs are not standardized among programs, which suggests a lack of instrument validity. The lack of established validity of the instruments used to evaluate students' clinical progress brings into question their ability to detect a student who is truly in jeopardy of attrition. Given this possibility, clinical instrument validity warrants research to be fair to students and improve attrition rates based on valid data. This ex post facto study evaluated a 17-item clinical instrument tool to demonstrate the need for validity of clinical evaluation tools. It also compared clinical scores with scores on the National Certification Examination.

  12. Clinical evaluation of nedocromil sodium in asthma.

    PubMed

    Holgate, S T

    1986-01-01

    The recognition that inflammatory events in the airways play a key role in the pathogenesis of asthma has led to a relentless search for pharmacological agents which modify these processes. Nedocromil sodium (Tilade) represents one such agent. Nedocromil sodium, when inhaled by patients with asthma (0.05-0.50% nebulized, 0.5-4.0 mg m.d.i.), has been shown to inhibit immediate bronchoconstriction provoked by challenges with allergen (10 studies), exercise (five studies), isocapnic hyperventilation, fog and sulphur dioxide (one study each) and adenosine (two studies). With these challenges, inhibition of bronchoconstriction exhibited dose-dependency up to 4 mg, with nedocromil sodium being up to four times more potent than sodium cromoglycate. When inhaled prior to allergen provocation, nedocromil sodium inhibited the late asthmatic reaction; when taken regularly during the pollen season, it attenuated the allergen-induced increase in non-specific bronchial responsiveness. The efficacy of nedocromil sodium (4 mg q.i.d.) in the treatment of clinical asthma was initially shown in four open studies and subsequently confirmed in nine double-blind, placebo-controlled 4-12 week studies on patients with seasonal and perennial asthma. Further clinical trials (eight studies) identified some difficulty in replacing inhaled corticosteroids with nedocromil sodium, especially if the corticosteroids were reduced rapidly (four studies). However, two studies have shown that nedocromil sodium produced further improvement in asthma symptoms when used in addition to bronchodilators and inhaled corticosteroids. Treatment with nedocromil sodium (4 mg q.i.d.) for up to 52 weeks demonstrated a progressive reduction in bronchodilator usage throughout the whole treatment period. During clinical assessment, nedocromil sodium was well tolerated, side-effects being unpleasant taste, nausea and headache. In most cases the adverse reactions were mild and transient, although in approximately 3% of

  13. Methodological framework for evaluating clinical processes: A cognitive informatics perspective.

    PubMed

    Kannampallil, Thomas G; Abraham, Joanna; Patel, Vimla L

    2016-12-01

    We propose a methodological framework for evaluating clinical cognitive activities in complex real-world environments that provides a guiding framework for characterizing the patterns of activities. This approach, which we refer to as a process-based approach, is particularly relevant to cognitive informatics (CI) research-an interdisciplinary domain utilizing cognitive approaches in the study of computing systems and applications-as it provides new ways for understanding human information processing, interactions, and behaviors. Using this approach involves the identification of a process of interest (e.g., a clinical workflow), and the contributing sequences of activities in that process (e.g., medication ordering). A variety of analytical approaches can then be used to characterize the inherent dependencies and relations within the contributing activities within the considered process. Using examples drawn from our own research and the extant research literature, we describe the theoretical foundations of the process-based approach, relevant practical and pragmatic considerations for using such an approach, and a generic framework for applying this approach for evaluation studies in clinical settings. We also discuss the potential for this approach in future evaluations of interactive clinical systems, given the need for new approaches for evaluation, and significant opportunities for automated, unobtrusive data collection.

  14. Pharmacologic and clinical evaluation of posaconazole.

    PubMed

    Moore, Jason N; Healy, Jason R; Kraft, Walter K

    2015-05-01

    Posaconazole, a broad-spectrum triazole antifungal agent, is approved for the prevention of invasive aspergillosis and candidiasis in addition to the treatment of oropharyngeal candidiasis. There is evidence of efficacy in the treatment and prevention of rarer, more difficult-to-treat fungal infections. Posaconazole oral suspension solution has shown limitations with respect to fasting state absorption, elevated gastrointestinal pH and increased motility. The newly approved delayed-release oral tablet and intravenous solution formulations provide an attractive treatment option by reducing interpatient variability and providing flexibility in critically ill patients. On the basis of clinical experience and further clinical studies, posaconazole was found to be a valuable pharmaceutical agent for the treatment of life-threatening fungal infections. This review will examine the development history of posaconazole and highlight the most recent advances.

  15. A Formative Program Evaluation of Electronic Clinical Tracking System Documentation to Meet National Core Competencies.

    PubMed

    Smith, Lynette S; Branstetter, M Laurie

    2016-09-01

    Electronic clinical tracking systems are used in many educational institutions of higher learning to document advanced practice registered nursing students' clinical experiences. Students' clinical experiences are constructed according to the National Organization of Nurse Practitioner Faculties core competencies. These competencies form a basis for evaluation of advanced practice registered nursing programs. However, no previous studies have evaluated the use of electronic clinical tracking systems to validate students' clinical experiences in meeting national core competencies. Medatrax, an electronic clinical tracking system, is evaluated using a formative program evaluation approach to determine if students' clinical documentations meet Family/Across the Lifespan Nurse Practitioner Competencies in a midsouthern family nurse practitioner program. This formative program evaluation supports the use of an electronic clinical tracking system in facilitating accreditation and program outcome goals. The significance of this study is that it provides novel evidence to support the use of an electronic clinical tracking system to assist a midsouthern school of nursing in meeting national core competencies.

  16. Evaluation of clinical ethics support services and its normativity.

    PubMed

    Schildmann, Jan; Molewijk, Bert; Benaroyo, Lazare; Forde, Reidun; Neitzke, Gerald

    2013-11-01

    Evaluation of clinical ethics support services (CESS) has attracted considerable interest in recent decades. However, few evaluation studies are explicit about normative presuppositions which underlie the goals and the research design of CESS evaluation. In this paper, we provide an account of normative premises of different approaches to CESS evaluation and argue that normativity should be a focus of considerations when designing and conducting evaluation research of CESS. In a first step, we present three different approaches to CESS evaluation from published literature. Next to a brief sketch of the well-established approaches of 'descriptive evaluation' and 'evaluation of outcomes', we will give a more detailed description of a third approach to evaluation-'reconstructing quality norms of CESS'-which is explicit about the normative presuppositions of its research (design). In the subsequent section, we will analyse the normative premises of each of the three approaches to CESS evaluation. We will conclude with a brief argument for more sensitivity towards the normativity of CESS and its evaluation research.

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

    PubMed

    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

  18. Comparative evaluation of 0.1% turmeric mouthwash with 0.2% chlorhexidine gluconate in prevention of plaque and gingivitis: A clinical and microbiological study

    PubMed Central

    Mali, Amita M.; Behal, Roobal; Gilda, Suhit S.

    2012-01-01

    Background: The aim of our clinical trial was to assess the efficacy of 0.1% turmeric mouthwash as an anti-plaque agent and its effect on gingival inflammation and to compare it with 0.2% chlorhexidine gluconate by evaluating the effect on plaque and gingival inflammation and on microbial load. Materials and Methods: 60 subjects, 15 years and above, with mild to moderate gingivitis were recruited. Study population was divided into two groups. Group A-30 subjects were advised chlorhexidine gluconate mouthwash. Group B-30 subjects were advised experimental (turmeric) mouthwash. Both the groups were advised to use 10 ml of mouthwash with equal dilution of water for 1 min twice a day 30 min after brushing. Parameters were recorded for plaque and gingival index at day 0, on 14 th day, and 21 st day. Subjective and objective criteria were assessed after 14th day and 21st day. The N-benzoyl-l-arginine-p- nitroanilide (BAPNA) assay was used to analyze trypsin like activity of red complex microorganisms. Results: On comparison between chlorhexidine and turmeric mouthwash, percentage reduction of the Plaque Index between 0 and 21 st day were 64.207 and 69.072, respectively (P=0.112), percentage reduction of Gingival Index between 0 and 21st day were 61.150 and 62.545 respectively (P=0.595) and percentage reduction of BAPNA values between 0 and 21st day were 42.256 and 48.901 respectively (P=0.142). Conclusion: Chlorhexidine gluconate as well as turmeric mouthwash can be effectively used as an adjunct to mechanical plaque control in prevention of plaque and gingivitis. Both the mouthwashes have comparable anti-plaque, anti-inflammatory and anti-microbial properties. PMID:23162334

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

    SciTech Connect

    Kumar, Syam; Aswathi, C.P.

    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.

  20. 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

    PubMed Central

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

    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 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. Methods 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. Results 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. Conclusion Extract of R. centifolia petals or EGCG could be useful ingredients in the treatment of scalp seborrheic dermatitis. PMID:25473226

  1. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406

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

    PubMed Central

    Kudva, Praveen; Tabasum, Syeda Tawkhira; Garg, Nidhi

    2010-01-01

    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 metabolic

  3. [Effect of data management quality on clinical research evidence evaluation].

    PubMed

    Gao, Hong-yang; Li, Qing-na; Zhao, Yang; Li, Bo; Rui, Gao

    2015-02-01

    Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.

  4. Clinical evaluation of terconazole. European experience.

    PubMed

    Hirsch, H A

    1989-08-01

    Terconazole is a new topical antifungal agent that differs structurally and functionally from the imidazoles. European clinical trials were conducted to determine (1) the lowest effective dose for a given treatment period, (2) which formulation should be tested further, and (3) how terconazole compares with other topical antifungal agents in terms of safety and efficacy. The results of dose-response studies demonstrated that 80- and 240-mg suppositories and 0.4% cream were the most effective formulations. Data from multicenter studies of pregnant and nonpregnant women in Belgium and Luxembourg indicate that the efficacy of terconazole cream is superior to that of miconazole nitrate cream and clotrimazole cream. Terconazole cream is also more effective than clotrimazole cream in terms of lower relapse rates.

  5. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment

    PubMed Central

    2013-01-01

    recruitment for the RCT it was decided to add a fourth non-randomized group, a PRCI Control group that received the PRCI and completed the questionnaires but did not complete daily monitoring. Discussion Positive reappraisal is one of the few ways of coping that has been shown to be associated with increased wellbeing during unpredictable and uncontrollable situations like medical waiting periods. A simple evidence based self-help intervention could facilitate coping during this common medical situation. This RCT study will evaluate the value of a self-help coping intervention designed for medical waiting periods in women undergoing fertility treatment. Trial registration The study is registered at the Clinical Tials.gov (NCT01701011). PMID:24004640

  6. Cognitive evaluation of an innovative psychiatric clinical knowledge enhancement system.

    PubMed

    Cohen, Trevor; Kaufman, David; White, Thomas; Segal, Gerald; Staub, Amy Bennett; Patel, Vimla; Finnerty, Molly

    2004-01-01

    Psychiatric Clinical Knowledge Enhancement System (PSYCKES) is an innovative information system that presents patient medication history in tabular and graphical form. The system is designed to support therapeutic decision making. In this paper, we present a multifaceted cognitive evaluation of this system. The evaluation includes a cognitive walkthrough which is a task-analytic method for usability evaluation. We also conducted cognitive studies of two trainee and two attending psychiatrists using the system. One of the attending subjects is presented as a case study. An objective of this research is to characterize the way PSYCKES mediates reasoning. The study found that clinicians were able to use the system effectively to extract and coordinate information and draw appropriate inferences. The expert clinicians were better able to construct a coherent patient representation. The study also documented a few usability problems pertaining to the temporal integration of patient data. PSYCKES is a multifaceted tool that can significantly enhance therapeutic decision making.

  7. Pyrolysis system evaluation study

    NASA Technical Reports Server (NTRS)

    1974-01-01

    An evaluation of two different pyrolysis concepts which recover energy from solid waste was conducted in order to determine the merits of each concept for integration into a Integrated Utility System (IUS). The two concepts evaluated were a Lead Bath Furnace Pyrolysis System and a Slagging Vertical Shaft, Partial Air Oxidation Pyrolysis System. Both concepts will produce a fuel gas from the IUS waste and sewage sludge which can be used to offset primary fuel consumption in addition to the sanitary disposal of the waste. The study evaluated the thermal integration of each concept as well as the economic impact on the IUS resulting from integrating each pyrolysis concepts. For reference, the pyrolysis concepts were also compared to incineration which was considered the baseline IUS solid waste disposal system.

  8. Implementing Peer Evaluation of Clinical Teaching

    ERIC Educational Resources Information Center

    Laske, Rita Ann

    2013-01-01

    Clinical education provides the nursing student opportunities to learn the practice of nursing. In the clinical setting, the nursing student applies classroom knowledge to the real patient care situation. The clinical instructor facilitates this important process by assisting students to integrate knowledge into their practice, improve their…

  9. Evaluation of an alternative care provider clinic for severe sleep-disordered breathing: a study protocol for a randomised controlled trial

    PubMed Central

    Ip-Buting, Ada; Kelly, Jenny; Santana, Maria J; Penz, Erika D; Flemons, W Ward; Tsai, Willis H; Fraser, Kristin L; Hanly, Patrick J; Pendharkar, Sachin R

    2017-01-01

    Introduction Despite the high prevalence of sleep-disordered breathing (SDB) and the significant health consequences associated with untreated disease, access to diagnosis and treatment remains a challenge. Even patients with severe SDB (severe obstructive sleep apnoea or hypoventilation), who are at particularly high risk of adverse health effects, are subject to long delays. Previous research has demonstrated that, within a sleep clinic, management by alternative care providers (ACPs) is effective for patients with milder forms of SDB. The purpose of this study is to compare an ACP-led clinic (ACP Clinic) for patients with severe SDB to physician-led care, from the perspective of clinical outcomes, health system efficiency and cost. Methods and analysis The study is a randomised, controlled, non-inferiority study in which patients who are referred with severe SDB are randomised to management by a sleep physician or by an ACP. ACPs will be supervised by sleep physicians for safety. The primary outcome is positive airway pressure (PAP) adherence after 3 months of therapy. Secondary outcomes include: long-term PAP adherence; clinical response to therapy; health-related quality of life; patient satisfaction; healthcare usage; wait times from referral to treatment initiation and cost-effectiveness. The economic analysis will be performed using the perspective of a publicly funded healthcare system. Ethics and dissemination Ethics approval was obtained from the Conjoint Health Research Ethics Board (ID: REB13-1280) at the University of Calgary. Results from this study will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals. Trial registration number NCT02191085; Pre-results. PMID:28360244

  10. Biosimilars entering the clinic without animal studies

    PubMed Central

    van Aerts, Leon AGJM; De Smet, Karen; Reichmann, Gabriele; van der Laan, Jan Willem; Schneider, Christian K

    2014-01-01

    The concept of biosimilars has spread from Europe to other regions throughout the world, and many regions have drafted regulatory guidelines for their development. Recently, a paradigm shift in regulatory thinking on the non-clinical development of biosimilars has emerged in Europe: In vivo testing should follow a step-wise approach rather than being performed by default. To not require animal testing at all in some instances can well be seen as a revolutionary, but science-based, step. Here, we describe the internal discussions that led to this paradigm shift. The mainstay for the establishment of biosimilarity is the pharmaceutical comparability based on extensive physicochemical and biological characterization. Pharmacodynamic comparability can be evaluated in in vitro assays, whereas pharmacokinetic comparability is best evaluated in clinical studies. It is considered highly unlikely that new safety issues would arise when comparability has been demonstrated based on physicochemical and in vitro comparative studies. PMID:25517301

  11. Automatic Evaluations in Clinically Anxious and Nonanxious Children and Adolescents

    ERIC Educational Resources Information Center

    Vervoort, Leentje; Wolters, Lidewij H.; Hogendoorn, Sanne M.; Prins, Pier J. M.; de Haan, Else; Nauta, Maaike H.; Boer, Frits

    2010-01-01

    Automatic evaluations of clinically anxious and nonanxious children (n = 40, aged 8-16, 18 girls) were compared using a pictorial performance-based measure of automatic affective associations. Results showed a threat-related evaluation bias in clinically anxious but not in nonanxious children. In anxious participants, automatic evaluations of…

  12. Clinical evaluation of sodium fluoride chewable tablets in dental caries.

    PubMed

    Aithal, K S; Udupa, D N; Tandon, S

    1996-01-01

    Chewable tablets containing low dosage fluoride content were prepared using two varieties of celluloses and their in vitro parameters were evaluated. An eighteen month clinical trial revealed that both these formulations were effective in controlling the caries. However, ethyl cellulose is proved to be superior to methylcellulose as a controlled release matrix material in controlling caries. Thus this study recommends ethylcellulose matrix tablets containing low fluoride content is an efficacious and cost effective drug device in controlling dental caries.

  13. Clinical evaluation of sodium flouride chewable tablets in dental caries.

    PubMed

    Maddi, S S; Tandon, S; Aithal, K S

    1999-01-01

    Chewable tablets containing low dosage flouride content were prepared using two varities of celluloses and their in vitro parameters were evaluated. An eighteen month clinical trial revealed that both these formulations were effective in controlling the caries. However, ethyl cellulose is proved to be superior to methylcellulose as a controlled release matrix material in controlling caries. Thus this study recommends ethylcellulose matrix tablets containing low flouride content is an efficacious and cost effective drug device in controlling dental caries.

  14. Evaluation of the appropriateness of the preclinical phase (stage A and stage B) of heart failure Management in Outpatient clinics in Italy rationale and design of the 'VASTISSIMO' study.

    PubMed

    Mureddu, Gian F; Nistri, Stefano; Faggiano, Pompilio; Fimiani, Biagio; Misuraca, Gianfranco; Maggi, Antonio; Gori, Anna M; Uguccioni, Massimo; Tavazzi, Luigi; Zito, Giovanni B

    2016-07-01

    Early detection of heart failure, when still preclinical, is fundamental. Therefore, it is important to assess whether preclinical heart failure management by cardiologists is adequate. The VASTISSIMO study ('EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of heart failure Management in Outpatient clinics in Italy') is a prospective nationwide study aimed to evaluate the appropriateness of diagnosis and management of preclinical heart failure (stages A and B) by cardiologists working in outpatient clinics in Italy. Secondary goals are to verify if an online educational course for cardiologists can improve management of preclinical heart failure, and evaluate how well cardiologists are aware of patients' adherence to medications. The study involves 80 outpatient cardiology clinics distributed throughout Italy, affiliated either to the Hospital Cardiologists Association or to the Regional Association of Outpatient Cardiologists, and is designed with two phases of consecutive outpatient enrolment each lasting 1 month. In phase 1, physicians' awareness of the risk of heart failure and their decision-making process are recorded. Subsequently, half of the cardiologists are randomized to undergo an online educational course aimed to improve preclinical heart failure management through implementation of guideline recommendations. At the end of the course, all cardiologists are evaluated (phase 2) to see whether changes in clinical management have occurred in those who underwent the educational program versus those who did not. Patients' adherence to prescribed medications will be assessed through the Morisky Self-report Questionnaire. This study should provide valuable information about cardiologists' awareness of preclinical heart failure and the appropriateness of clinical practice in outpatient cardiology clinics in Italy.

  15. Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98--FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns.

    PubMed

    Hickel, Reinhard; Roulet, Jean-François; Bayne, Stephen; Heintze, Siegward D; Mjör, Ivar A; Peters, Mathilde; Rousson, Valentin; Randall, Ros; Schmalz, Gottfried; Tyas, Martin; Vanherle, Guido

    2007-01-01

    About 35 years ago, Ryge provided a practical approach to the evaluation of the clinical performance of restorative materials. This systematic approach was soon universally accepted. While that methodology has served us well, a large number of scientific methodologies and more detailed questions have arisen that require more rigor. Current restorative materials have vastly improved clinical performance, and any changes over time are not easily detected by the limited sensitivity of the Ryge criteria in short-term clinical investigations. However, the clinical evaluation of restorations not only involves the restorative material per se but also different operative techniques. For instance, a composite resin may show good longevity data when applied in conventional cavities but not in modified operative approaches. Insensitivity, combined with the continually evolving and nonstandard investigator modifications of the categories, scales, and reporting methods, has created a body of literature that is extremely difficult to interpret meaningfully. In many cases, the insensitivity of the original Ryge methods leads to misinterpretation as good clinical performance. While there are many good features of the original system, it is now time to move on to a more contemporary one. The current review approaches this challenge in two ways: (1) a proposal for a modern clinical testing protocol for controlled clinical trials, and (2) an in-depth discussion of relevant clinical evaluation parameters, providing 84 references that are primarily related to issues or problems for clinical research trials. Together, these two parts offer a standard for the clinical testing of restorative materials/procedures and provide significant guidance for research teams in the design and conduct of contemporary clinical trials. Part 1 of the review considers the recruitment of subjects, restorations per subject, clinical events, validity versus bias, legal and regulatory aspects, rationales for

  16. Interrater reliability of clinical tests to evaluate scapulothoracic motion

    PubMed Central

    2013-01-01

    Background Decreased scapulothoracic motion has been associated with various pathologies of the shoulder. Reliable and simple assessment methods of scapular mobility are, however lacking. The aim of this study was to evaluate the interrater reliability of four clinical tests to assess scapulothoracic motion in patients with a slightly restricted shoulder flexion. Methods A total of nineteen patients with a symptomatic slight restriction of shoulder flexion and twenty asymptomatic subjects were evaluated. The investigation consisted of four palpatory tests to assess scapulothoracic motion. A two-level rating scale (positive, negative) was utilised. Interrater reliability was evaluated using kappa coefficients. Results We found substantial to almost perfect (Kappa = 0.63-0.4) interrater reliability for the four tests. Conclusion Our study demonstrates that the four mobility tests of the shoulder are a reliable and simple instrument to assess patients with a slightly restricted shoulder flexion. Future studies should be conducted to evaluate the validity of these tests and to establish their clinical usefulness. PMID:24192253

  17. Evaluation of the effect of methylphenidate by computed tomography, electroencephalography, neuropsychological tests, and clinical symptoms in children with attention-deficit/hyperactivity disorder: A prospective cohort study

    PubMed Central

    Yildiz Oc, Ozlem; Agaoglu, Belma; Sen Berk, Fatma; Komsuoglu, Sezer; Karakaya, Isik; Coskun, Aysen

    2007-01-01

    Background: Stimulant drugs are the most commonly used treatments for attention-deficit/hyperactivity disorder (ADHD), although the mechanism of action of these drugs is still not entirely understood. Objective: The aim of this study was to investigate the effects of the psychostimulant drug methylphenidate (MPH) on regional cerebral blood flow (rCBF), electrical activity of the brain, and clinical symptoms in children with ADHD using single-photon emission computed tomography (SPECT), electroencephalography (EEG), and neuropsychological tests. Methods: In this prospective cohort study, pediatric outpatients received MPH for 3 months at a mean dose of 1 mg/kg · d (range, 0.5–1.5 mg/kg · d). They were then administered the Wechsler Intelligence Scale for Children-Revised, the Bender Visual-Motor Gestalt Test (BGT), EEG, and SPECT of the brain. The parents and/or teacher of each child were asked to complete the Conners' Parent Rating Scale (CPRS), the Conners' Teacher Rating Scale (CTRS), and the Turgay Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-based Child and Adolescent Behavior Disorders Screening and Rating Scale (T-DSM-IV-S). All of the evaluations were performed at baseline and after 3 months of MPH treatment. Each child underwent a Stroop test as an activation method 15 minutes before the SPECT procedure. Results: Sixty patients were assessed for inclusion. Twenty-one children (18 boys [85.7%], 3 girls [14.3%]; mean [SD] age, 9.7 [1.7] years; range, 8–13 years) with a diagnosis of ADHD were included in and completed the study. Mean (SD) BGT scores before MPH treatment compared with after MPH treatment were significantly decreased (9.8 [4.2] vs 6.3 [3.4]; Z = -3.27; P = 0.001). After treatment with MPH, the visual SPECT results suggested that low rCBF was normalized in the right frontotemporal areas in 10 children with ADHD. After treatment, 12 patients (57.1%) had no change in EEG activity, 5 (23.8%) had improvement, and 4 (19

  18. Clinical evaluation of a new flossing device.

    PubMed

    Pucher, J; Jayaprakash, P; Aftyka, T; Sigman, L; Van Swol, R

    1995-04-01

    The clinical effectiveness of a new flossing device, the Floss Plus easy flosser, in reducing interproximal plaque and interproximal gingival inflammation was compared to the effectiveness of hand-held floss. The first phase studied 36 dental students, while the second studied 26 adult patients undergoing supportive periodontal treatment. In both phases, the subjects were divided into two groups. One group used the flossing device, while the second group used hand-held floss. The Gingival Index and Plaque Index were taken at baseline, 1 week, and 6 weeks. All groups experienced a significant decrease in the amount of interproximal inflammation and plaque, regardless of which flossing method was used. There was no statistically significant difference between the two flossing methods in the reduction of interproximal inflammation or plaque. These results indicated that the Floss Plus easy flosser is as effective as hand-held floss in reducing interproximal plaque and gingivitis. The use of this aid may benefit those patients who lack the dexterity for hand-held floss or who find flossing cumbersome.

  19. PA01.17. A clinical study to evaluate the effect of extract based herbal formulation on hypertension- a single blinded standard controlled randomized study

    PubMed Central

    Agrawal, Satish; Pol, Hemant

    2012-01-01

    Purpose: In Ayurveda although there is no such terminology like hypertension but still this work is an approach to establish relationship between Hypertension & vitiated functioning of three governing forces of our body i.e. Tridosha and to treat Hypertension on Ayurvedic principles. The logic behind such correlation is based on the fact that, like other physiological processes, B.P. too is normal phenomenon of our body which is governed by Tridosha. After going through modern pathogenesis of primary hypertension and its symptomology, in present study it has been correlated with Vata Kaphaja Vikara with Rasavaha, Raktavaha and Manovahi Srotas as the seat of disease. Looking at its pathogenesis, the term Uccha Vyan Bala (exaggerated physiological functioning of Vyan Vayu leading to increase contractility of heart & blood vessels) can be coined for hypertension. Method: Subjective criteria Headache, Palpitation, Vertigo, Dyspnoea on walks and Fatigue. Objective criteria BP value recorded by sphygmomanometer in supine position. Final assessment of results; Subjective assessment 75 to 100% disappearance of symptoms effectively cured. 50 to 74% disappearance of symptoms well cured. 25 to 49% disappearance of symptoms fairly cured. 0 to 24% disappearance of symptoms poorly cured. Objective assessment Patient showing reduction in BP by 10mmHg Poorly cured; Patient showing reduction in BP between 11 to 20mmHg Fairly cured; Patient showing reduction in BP between 21 to 30 mmHg Well cured; Patient showing reduction in BP by more than 30 mmHg Effectively cured. Research methodology Type of study-Single blinded comparative study. Study site IPD and OPD department of Shubhdeep ayurved medical college, Indore (MP). Sample size 50 patients divided randomly into two equal groups. Group A given trial drug whereas Group B given control drug. Drug dosage and vehicle 1 capsule twice daily with lukewarm water after meals. Duration of treatment one month (examined at weekly intervals

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

    PubMed

    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.

  1. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    PubMed

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome.

  2. Photovoltaic evaluation study

    NASA Astrophysics Data System (ADS)

    Johnson, G.; Heikkilae, M.; Melasuo, T.; Spanner, S.

    Realizing the value and potential of PV-power as well as the growing need for increased cooperation and sharing of knowledge in the field of photovoltaics, FINNIDA and UNICEF decided to undertake a study of selected PV-projects. There were two main objectives for the study: To gather, compile, evaluate and share information on the photovoltaic technology appropriate to developing countries, and to promote the interest and competence of Finnish research institutes, consultants and manufacturers in photovoltaic development. For this purpose a joint evaluation of significant, primarily UN-supported projects providing for the basic needs of rural communities was undertaken. The Gambia and Kenya offered a variety of such projects, and were chosen as target countries for the study. The projects were chosen to be both comparable and complimentary. In the Gambia, the main subject was a partially integrated health and telecommunications project, but a long-operating drinking water pumping system was also studied. In Kenya, a health project in the Turkana area was examined, and also a large scale water pumping installation for fish farming. Field visits were made in order to verify and supplement the data gathered through document research and earlier investigations. Individual data gathering sheets for the project form the core of this study and are intended to give the necessary information in an organized and accessible format. The findings could practically be condensed into one sentence: PV-systems work very well, if properly designed and installed, but the resources and requirements of the recipients must be considered to a higher degree.

  3. Pre-clinical and Clinical Evaluation of High Resolution, Mobile Gamma Camera and Positron Imaging Devices

    DTIC Science & Technology

    2010-10-01

    04-1-0594 TITLE: Pre-clinical and Clinical Evaluation of High Resolution, Mobile Gamma Camera and Positron Imaging Devices PRINCIPAL...2004 - 20 SEP 2010 4. TITLE AND SUBTITLE Pre-clinical and clinical evaluation of high resolution, mobile gamma camera and positron imaging devices...a compact and mobile gamma and positron imaging camera . This imaging device has several advantages over conventional systems: (1) greater

  4. Clinical Evaluation--An Instructor's Dilemma.

    ERIC Educational Resources Information Center

    Meisenhelder, Janice Bell

    1982-01-01

    Guidelines are presented to assist the clinical nursing instructor in deciding whether to give a nursing student a failing grade. The guidelines discuss teacher support of a student, feedback, documentation, and colleague support. (CT)

  5. Clinical and diagnostic evaluation of acoustic neuromas.

    PubMed

    Stucken, Emily Z; Brown, Kevin; Selesnick, Samuel H

    2012-04-01

    In the past century, significant advances have been made in understanding the clinical features of acoustic neuromas. Furthermore, rapid technological advances have led to the development of sensitive, rapid, and relatively noninvasive diagnostic modalities, which has allowed for earlier discovery of acoustic neuromas and has reduced the average tumor size at time of diagnosis. The ultimate result has been improved clinical outcomes after surgery and radiotherapy.

  6. Evaluation of peripheral blood microsampling techniques in combination with liquid chromatography-high resolution mass spectrometry for the determination of drug pharmacokinetics in clinical studies.

    PubMed

    Rincón, Juan P; Meesters, Roland J W

    2014-06-01

    New bioanalytical assays were developed, validated, and applied in a clinical study for quantitative measurement of acetaminophen concentrations in blood and plasma samples. Furthermore, after validation, the bioanalytical assays were used for determination of pharmacokinetics within a group of six healthy male human volunteers after admission of a single oral dose of 500 mg of acetaminophen. Quantitative analyses were done by means of liquid chromatography-high resolution mass spectrometry and blood samples were collected at various sampling time points using different peripheral blood microsampling techniques. Post-dose peripheral collected blood samples were applied for the preparation of dry blood spots, dried matrix on paper discs, and peripheral plasma. Pharmacokinetic parameters determined were clearance (Cl), area under the curve (AUC), volume of distribution (Vd ), peak concentration (Cmax ), time of occurrence of peak concentration (Tmax ) and half-life time (T½ ). Observed pharmacokinetic values were not statistically (ANOVA) different compared to in literature reported values based on venous blood collection. The present pilot study demonstrated the feasibility of peripheral blood microsampling techniques in combination with quantitative liquid chromatography-high resolution mass spectrometry analysis for the determination of pharmacokinetics in clinical studies.

  7. [Clinical evaluation of vertigo in menopausal women].

    PubMed

    Owada, Satoko; Yamamoto, Masahiko; Suzuki, Mitsuya; Yoshida, Tomoe; Nomura, Toshiyuki

    2012-05-01

    Vertigo is one of the usual menopausal symptoms. We have often examined some women under the complaint of vertigo related with the menopause. We diagnosed each disease based on neuro-otological examinations and investigated the characteristics of menopausal-associated vertigo. We studied 413 women aged 40-59 years old who complained of vertigo. There were 73 women with menopause symptoms (14 women introduced from the gynecologist in our medical center, 18 women had undergone treatment at another female clinic, and 41 women visited an otorhinolaryngologist first) compared with 340 women without menopause symptoms. In the menopause group, 41 (56.2%) cases were diagnosed as having benign paroxysmal positional vertigo (BPPV), 13 (17.8%) cases had Meniere's disease, sudden deafness with vertigo accounted 2 cases, one was an acoustic tumor, and so on. The percentage of patients with BPPV was almost same ratio between the menopause group (56.2%) and the non-menopause group (52.9%). The percentage of patients with Meniere's disease was higher markedly in the menopausal group (17.8%). than the non-menopause group (9.7%). Menopausal symptoms are caused not only by hot flashes related to a lack of estrogen but also by psychological factors. The onset of Meniere's disease can also be influenced by psychological factors. As for the diagnosis of Meniere's disease, we supposed the reason for the higher percentage in the menopausal group was its relationship with psychological factors. We could diagnose and treat some menopausal women with vertigo. We believe that joint consultation with a gynecologist and otorhinolaryngologist would be necessary to ensure an optimum quality of life for such patients.

  8. Cross-system evaluation of clinical trial search engines.

    PubMed

    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.

  9. Cross-System Evaluation of Clinical Trial Search Engines

    PubMed Central

    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. PMID:25954590

  10. A comparative evaluation of the effectiveness of subpedicle acellular dermal matrix allograft with subepithelial connective tissue graft in the treatment of isolated marginal tissue recession: A clinical study

    PubMed Central

    Shori, Tony; Kolte, Abhay; Kher, Vishal; Dharamthok, Swarup; Shrirao, Tushar

    2013-01-01

    Introduction: The most common problem encountered in our day to day practice is exposed root surface or a tooth getting long. The main indication for root coverage procedures are esthetics and/or cosmetic demands followed by the management of root hypersensitivity, root caries or when it hampers proper plaque removal. Over the years, various techniques have been used to achieve root coverage. Aim and Objectives: The aim of this study was to compare the effectiveness of subpedicle acellular dermal matrix allograft (ADMA) with subepithelial connective tissue graft (SCTG) in the treatment of isolated marginal tissue recession. Materials and Methods: Twenty systemically healthy patients aged between 18 to 50 years (mean age29.7±4.35 years) with a recession defect on the labial and the buccal surfaces of any teeth were selected for the study. Ten patients received the test treatment (ADMA), ten patients received the control treatment (SCTG). Clinical recordings assessed at baseline, three months and six months post surgery, included Plaque index (PI), Papillary bleeding index (PBI), Gingival recession (REC), Probing pocket depth (PPD), Clinical attachment level (CAL) and Width of keratinized gingival (WKG). Results: Test group (ADMA) showed 86.93% mean root coverage while control group (SCTG) showed 84.72% at six months post surgery. Mean increase in the width of keratinized gingiva was significantly greater in the SCTG group (3.3±0.48mm) compared to ADMA group (2.4±0.51mm). Conclusion: Both the treatment produced a significant reduction in gingival recession and probing pocket depth and significant gain in clinical attachment level and width of keratinised gingiva. PMID:23633778

  11. The Clinical Evaluation of Parkinson's Tremor.

    PubMed

    Zach, Heidemarie; Dirkx, Michiel; Bloem, Bastiaan R; Helmich, Rick 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 basis for further tailored treatment. This can be challenging, because Parkinson's tremor amplitude is typically very variable and context-dependent. Here, we outline how we investigate Parkinson's tremor in the clinic. We describe a simple set of clinical tasks that can be used to constrain tremor variability (cognitive and motor co-activation, several specific limb postures). This may help to adequately characterize the tremor(s) occurring in a patient with Parkinson's disease.

  12. Patients' awareness of the potential benefit of smoking cessation. A study evaluating self-reported and clinical data from patients referred to an oral medicine unit.

    PubMed

    Bornstein, Michael M; Frei, Marc; Sendi, Pedram; Ramseier, Christoph A; Reichart, Peter A

    2012-02-01

    The present study analyzed history of smoking and willingness to quit smoking in patients referred for diagnosis and treatment of different oral mucosal lesions. Prior to the initial clinical examination, patients filled in a standardized questionnaire regarding their current and former smoking habits and willingness to quit. Definitive diagnoses were classified into three groups (benign/reactive lesions, premalignant lesions and conditions, and malignant diseases) and correlated with the self-reported data in the questionnaires. Of the 980 patients included, 514 (52%) described themselves as never smokers, 202 (21%) as former smokers, and 264 (27%) as current smokers. In the group of current smokers, 23% thought their premalignant lesions/conditions were related to their smoking habit, but only 15% of the patients with malignant mucosal diseases saw that correlation. Only 14% of the smokers wanted to commence smoking cessation within the next 30 days. Patients with malignant diseases (31%) showed greater willingness to quit than patients diagnosed with benign/reactive lesions (11%). Future clinical studies should attempt (1) to enhance patients' awareness of the negative impact of smoking on the oral mucosa and (2) to increase willingness to quit in smokers referred to a dental/oral medicine setting.

  13. [Organization of an anaesthesia preoperative evaluation clinic - The Anaesthesia/Patient Blood Management Clinic: one Model].

    PubMed

    Schöpper, Christa; Venherm, Stefan; Van Aken, Hugo; Ellermann, Ines; Steinbicker, Andrea

    2016-04-01

    The anesthesia preoperative evaluation has been developed in recent years in a centralized clinic, that can be visited by the majority of patients, in order to evaluate and obtain patient's consent for anesthesia. In the current article, the organization and structure of such a central anesthesia preoperative evaluation clinic in the Department of Anesthesia, Intensive Care and Pain Medicine at the University Hospital of Muenster, is described. Besides the central preoperative evaluation clinic, 3 clinics are localized in separate buildings and preoperative visits have to be completed in special scenarios on the wards, too. A pharmaceutical evaluation for patient's medication and the patient blood management have been integrated into the anesthesia preoperative evaluation clinic. Processes are explained and current numbers of patients are mentioned.

  14. Genetic and clinical evaluation of juvenile retinoschisis

    PubMed Central

    Kim, Judy E.; Ruttum, Mark S.; Koeberl, Matthew J.; Hassemer, Eryn L.; Sidjanin, D. J.

    2014-01-01

    Juvenile retinoschisis is a rare retinal dystrophy caused by RS1 gene mutations.1 Clinical examinations and molecular testing definitively diagnosed juvenile retinoschisis in 2 male infants, one of whom had a novel mutation not previously reported in the United States. Genetic testing may be the simplest way to confirm this diagnosis in infants. PMID:19393523

  15. Genetic and clinical evaluation of juvenile retinoschisis.

    PubMed

    Kim, Judy E; Ruttum, Mark S; Koeberl, Matthew J; Hassemer, Eryn L; Sidjanin, D J

    2009-04-01

    Juvenile retinoschisis is a rare retinal dystrophy caused by RS1 gene mutations.(1) Clinical examinations and molecular testing definitively diagnosed juvenile retinoschisis in 2 male infants, one of whom had a novel mutation not previously reported in the United States. Genetic testing may be the simplest way to confirm this diagnosis in infants.

  16. A clinical evaluation of benzydamine hydrochloride.

    PubMed

    Hunter, K M

    1978-04-01

    A double-blind clinical trial of the effects of the use of benzydamine hydrochloride for patients undergoing the surgical removal of impacted lower third molar teeth showed no significant effects on swelling and trismus between control and experimental groups, although a significant reduction in the post-operative consumption of analgesics was noted.

  17. [Clinical studies in developing countries].

    PubMed

    van den Munkhof, Hanna E

    2013-01-01

    In general, clinical trials in developing countries are met with resistance because the people are particularly vulnerable and medical assistance is often unaffordable. The prospect of free medication can then lead to exploitation since the local population can be persuaded to participate in trials that would never be allowed in Western countries due to ethical concerns. Placebo-controlled research that tests cheaper alternatives for treatments already registered could greatly improve the situation in developing countries, however. Expensive registered treatments are often unavailable in these countries. Therefore, I call for allowing such studies when the registered treatment is locally unavailable. This should be based on the four most important principles of medical ethics: the duty to help patients, avoid harm, justice and respect for autonomy. On the condition, however, that the population in developing countries benefits in the long term.

  18. Clinical Evaluation of Baccalaureate Nursing Students Using SBAR Format: Faculty versus Self Evaluation

    ERIC Educational Resources Information Center

    Saied, Hala; James, Joemol; Singh, Evangelin Jeya; Al Humaied, Lulawah

    2016-01-01

    Clinical training is of paramount importance in nursing education and clinical evaluation is one of the most challenging responsibilities of nursing faculty. The use of objective tools and criteria and involvement of the students in the evaluation process are some techniques to facilitate quality learning in the clinical setting. Aim: The aim of…

  19. Evaluation of a Computerized Clinical Information System (Micromedex).

    PubMed

    Lundsgaarde, H P; Moreshead, G E

    1991-01-01

    This paper summarizes data collected as part of a project designed to identify and assess the technical and organizational problems associated with the implementation and evaluation of a Computerized Clinical Information System (CCIS), Micromedex, in three U.S. Department of Veterans Affairs Medical Centers (VAMCs). The study began in 1987 as a national effort to implement decision support technologies in the Veterans Administration Decentralized Hospital Computer Program (DHCP). The specific objectives of this project were to (1) examine one particular decision support technology, (2) identify the technical and organizational barriers to the implementation of a CCIS in the VA host environment, (3) assess the possible benefits of this system to VA clinicians in terms of therapeutic decision making, and (4) develop new methods for identifying the clinical utility of a computer program designed to provide clinicians with a new information tool. The project was conducted intermittently over a three-year period at three VA medical centers chosen as implementation and evaluation test sites for Micromedex. Findings from the Kansas City Medical Center in Missouri are presented to illustrate some of the technical problems associated with the implementation of a commercial database program in the DHCP host environment, the organizational factors influencing clinical use of the system, and the methods used to evaluate its use. Data from 4581 provider encounters with the CCIS are summarized. Usage statistics are presented to illustrate the methodological possibilities for assessing the "benefits and burdens" of a computerized information system by using an automated collection of user demographics and program audit trails that allow evaluators to monitor user interactions with different segments of the database.

  20. Athletic Training Approved Clinical Instructors' Reports of Real-Time Opportunities for Evaluating Clinical Proficiencies

    PubMed Central

    Armstrong, Kirk J.; Weidner, Thomas G.; Walker, Stacy E.

    2009-01-01

    Abstract Context: Appropriate methods for evaluating clinical proficiencies are essential to ensuring entry-level competence in athletic training. Objective: To identify the methods Approved Clinical Instructors (ACIs) use to evaluate student performance of clinical proficiencies. Design: Cross-sectional design. Setting: Public and private institutions in National Athletic Trainers' Association (NATA) District 4. Patients or Other Participants: Approved Clinical Instructors from accredited athletic training education programs in the Great Lakes Athletic Trainers' Association, which is NATA District 4 (N  =  135). Data Collection and Analysis: Participants completed a previously validated survey instrument, Methods of Clinical Proficiency Evaluation in Athletic Training, that consisted of 15 items, including demographic characteristics of the respondents and Likert-scale items (1  =  strongly disagree to 5  =  strongly agree) regarding methods of clinical proficiency evaluation, barriers, educational content areas, and clinical experience settings. We used analyses of variance and 2-tailed, independent-samples t tests to assess differences among ACI demographic characteristics and the methods, barriers, educational content areas, settings, and opportunities for feedback regarding clinical proficiency evaluation. Qualitative analysis of respondents' comments was completed. Results: The ACIs (n  =  106 of 133 respondents, 79.7%) most often used simulations to evaluate clinical proficiencies. Only 59 (55.1%) of the 107 ACIs responding to a follow-up question reported that they feel students engage in a sufficient number of real-time evaluations to prepare them for entry-level practice. An independent-samples t test revealed that no particular clinical experience setting provided more opportunities than another for real-time evaluations (t119 range, −0.909 to 1.796, P ≥ .05). The occurrence of injuries not coinciding with the clinical proficiency

  1. Evaluation of RxNorm for Medication Clinical Decision Support

    PubMed Central

    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. PMID:25954360

  2. Evaluation of RxNorm for Medication Clinical Decision Support.

    PubMed

    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.

  3. Comparative clinical and radiographic evaluation of mineralized cancellous bone allograft (puros®) and autogenous bone in the treatment of human periodontal intraosseous defects: 6-months follow-up study

    PubMed Central

    Reddy, B. Ravinder; Sudhakar, J.; Rajesh, Nichenametla; Sandeep, V.; Reddy, Y. Muralidhar; Gnana Sagar, W. R.

    2016-01-01

    Aims: Several materials have been introduced as bone grafts, i.e., autografts, allograft, xenografts, and alloplastic grafts, and studies have shown them to produce greater clinical bone defect fill than open flap debridement alone. The aim of this clinical and radiological 6-month study was to compare and evaluate the clinical outcome of deep intraosseous defects following reconstructive surgery with the use of mineralized cancellous bone allograft (Puros®) or autogenous bone. Materials and Methods: Ten patients with 12 sites exhibiting signs of moderate generalized chronic periodontitis were enrolled in the study. The investigations were confined to two and three-walled intra bony defects with a preoperative probing depth of ≥5 mm. Six of these defects were treated with Puros® (group A) the remaining six were treated with autogenous bone graft (group B). Allocation to the two groups was randomized. The clinical parameters, plaque index (PI), gingival index (GI), probing pocket depth (PPD), clinical attachment level (CAL), and bone fill, were recorded at different time intervals at the baseline, 1 month, 3 months, and 6 months. Intraoral radiographs were taken using standardized paralleling cone technique at baseline, 1, 3, and 6 months. Statistical analysis was done by using the one-way analysis of variance (ANOVA) followed by Tukey highly significant difference. Results: Both groups resulted in decrease in probing depth (group A, 3.0 mm; group B, 2.83 mm) and gain in clinical attachment level (group A, 3.33 mm; group B, 3.0 mm) over a period of 6 months, which was statistically insignificant. Conclusion: Within the limitations of the present study, it can be concluded that both mineralized cancellous bone allograft (Puros®) or autogenous bone result in significant clinical improvements. PMID:28217545

  4. Video as a strategy to evaluate and assist clinical teachers with student assessment.

    PubMed

    Kevin, Jim; Downie, Judith; Kendall, Sharon

    2007-01-01

    The assessment of the clinical competence of nursing students requires expertise in nursing as well as skills in student assessment. The development of these student assessment skills is dependent on the preparation of the clinical teacher. The results of this pilot study indicate that video can be one successful tool in evaluating the assessment skills of clinical teachers. Video also may be useful as a staff development tool by providing a nonthreatening way for clinical teachers to familiarize themselves with clinical assessment. In turn, this will have benefits for universities and students by ensuring consistency of clinical assessment by clinical teachers.

  5. A Model for Evaluating Student Clinical Psychomotor Skills.

    ERIC Educational Resources Information Center

    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)

  6. [Movement therapy and depression--evaluation study of a disorder-oriented and an unspecific movement-therapeutic support in clinical context].

    PubMed

    Heimbeck, Alexander; Hölter, Gerd

    2011-05-01

    In recent years body-orientated concepts have gained more and more importance in the therapy of mental disorders. But there is still a widespread skepticism about the effectiveness of movement-therapeutic measures. In the present study the effectiveness of an unspecific versus a disorder-orientated movement-therapy was tested in the clinical setting including a 6-month catamnesis with depressive patients (n=103) with a BDI >18. The results show, at every data point, the effectiveness of the measures for all investigated parameters. Both forms of movement-orientated interventions differ only slightly with regard to the therapeutic success. The catamnesis shows a big gap between resolution and actually realized activities. On the basis of the results it can be assumed that mainly general unspecific determinants play a more important role for the therapeutic success than assumed so far.

  7. Electronic Clinical Safety Reporting System: A Benefits Evaluation

    PubMed Central

    Martin, Desmond; Neville, Doreen

    2014-01-01

    Background 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. Objective 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. Methods 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. Results 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

  8. Reversal of dental fluorosis: A clinical study

    PubMed Central

    Mehta, Dhaval N.; Shah, Jigna

    2013-01-01

    Aim: This study was conducted to evaluate the clinical reversal of dental fluorosis with various combinations of calcium, vitamin D3, and ascorbic acid, along with changes in levels of certain biochemical parameters concerned with dental fluorosis. The role of fluoride level of drinking water in the etiology of dental fluorosis and the prevalence of dental fluorosis in both dentitions and teeth were also assessed. Materials and Methods: A total number of 50 patients with clinical features of dental fluorosis without trauma and any adverse habits were selected. Of these, in 30 co-operative patients, estimation of water fluoride level and pretreatment and post-treatment serum and urine fluoride levels were done with ion selective electrode method. The selected 30 patients were divided into three groups, that is, group A, group B, and group C, and were given various combinations of medications like calcium with vitamin D3 supplements, ascorbic acid with vitamin D3 supplements, and chlorhexidine mouthwash (placebo) for three months, respectively. These 30 patients were assessed for any change in the clinical grading of dental fluorosis. Results: No change in clinical grading of dental fluorosis was noted. Considerable reduction in serum and urine fluoride levels was noted in both group A and group B patients. Dental fluorosis was noted in permanent teeth more commonly than deciduous teeth, and permanent maxillary central incisors had the highest prevalence rate. Conclusion: This study comprises only 30 patients with three months of follow-up. So, this sample of patients and duration of follow-up period are conclusive to observe changes in biochemical parameters but not sufficient to observe changes in clinical grading. PMID:23633850

  9. [Shared web-based data center for multi-institutional clinical trials: evaluation of UMIN-INDICE (university hospital medical information network-internet data and information center for medical research)in clinical trials of JIVROSG (Japan interventional radiology in oncology study group)].

    PubMed

    Sone, Miyuki; Arai, Yasuaki; Kiuchi, Takahiro; Ishikawa, Hirono; Aoki, Noriaki; Inaba, Yoshitaka; Yoshioka, Tetsuya; Aramaki, Takeshi; Kobayashi, Takeshi; Matsuoka, Toshiyuki; Anai, Hiroshi; Tanigawa, Noboru; Osuga, Keigo; Takeuchi, Yoshito; Okusaka, Takushi; Kanazawa, Susumu; Matsui, Osamu; Endo, Keigo

    2012-04-01

    A patient registration system is mandatory for establishing the scientific credibility of the multi-center clinical trials. The Japan Interventional Radiology in Oncology Study Group (JIVROSG) was organized in 2002 to establish evidence supporting the procedures used in interventional radiology. The Internet Data and Information Center for Medical Research (INDICE), provided by the University Hospital Medical Information Network(UMIN), has been utilized for patient registration in the clinical trials of JIVROSG. In this study, the safety and efficacy of UMIN-INDICE were evaluated. From 2002 to 2010, 18 clinical trials, including one international trial, were conducted. A total of 736 patients were enrolled from 51 institutions. No significant trouble was encountered during this period. A questionnaire survey demonstrated that 90% of participating researchers could use this system without difficulties. UMIN-INDICE may contribute to promoting clinical trials as an infrastructure of multicenter studies.

  10. Echocardiographic evaluation of clinically healthy Florida manatees (Trichechus manatus latirostris).

    PubMed

    Gerlach, Trevor J; Estrada, Amara H; Sosa, Ivan S; Powell, Melanie; Maisenbacher, Herbert W; de Wit, Martine; Ball, Ray L; Walsh, Michael T

    2013-06-01

    Antemortem studies pertaining to the manatee cardiovascular and cardiopulmonary systems are limited despite reports of cardiac disease in postmortem specimens. The objective of this project was to develop a technique for echocardiography in the Florida manatee (Trichechus manatus latirostris). Because of their unique anatomy, a ventral approach was employed by use of an echocardiography table designed specifically for this study. Fourteen clinically healthy, free-ranging and captive Florida manatees underwent echocardiography between the fall of 2011 and winter of 2012. Eight females and six males of various age categories were included in the study. Clear visualization of all valves and chambers was accomplished, and length and width measurements of the left atrium, peak aortic flow velocity, and ejection fraction percentage were calculated in most animals. Abnormalities observed during the study included atrioventricular regurgitation and severe right-atrial enlargement. Based on the results of this study, echocardiography in the Florida manatee is possible, which has both clinical and research implications in larger epidemiologic studies evaluating diseases of the cardiopulmonary and cardiovascular systems.

  11. Comparative evaluation of management of gingival recession using subepithelial connective tissue graft and collagen membrane by periodontal microsurgical technique: A clinical study of 40 cases

    PubMed Central

    Thankkappan, Prasanth; Roy, Subrata; Mandlik, Vivek Bapurao

    2016-01-01

    Background: New technologies, instruments, and surgical techniques are necessary to help the clinician ensure the best result and satisfy the patient's expectations, and surgical microscope has been thoroughly demonstrated as a useful tool. A clinical study was carried out to compare 2 different types of root coverage procedures using periodontal microsurgical procedure. Materials and Methods: Forty patients were selected and divided into Group A and Group B. Group A subjects were treated with subepithelial connective tissue graft (CTG) whereas Group B subjects were treated using a resorbable collagen membrane. The procedures were performed with the help of an operating microscope using 250 mm objective lens and ×6 magnification. Results: A comparison between baseline, 1, 3, and 12 months have been done between groups among all parameters. It has been noticed that the root coverage was better in Group A subjects at all time. At 12 months, Group A showed 81.42% coverage where in Group B it was 70.08%. Similarly, increase in the width of keratinized gingiva and attached gingiva were more in Group A. Conclusions: The present study showed that use of microsurgical instrument helped to deliver precise incision, better visual acuity, and improved illumination which facilitate to gain a better final outcome. Root coverage was better in the patients using CTG. PMID:27143833

  12. Clinical evaluation of the role of tulsi and turmeric in the management of oral submucous fibrosis: A pilot, prospective observational study

    PubMed Central

    Srivastava, Adit; Agarwal, Rahul; Chaturvedi, T. P.; Chandra, Akhilesh; Singh, O. P.

    2015-01-01

    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. PMID:25878464

  13. Evaluation of the clinical usefulness of modulated arc treatment

    NASA Astrophysics Data System (ADS)

    Lee, Young Kyu; Jang, Hong Seok; Kim, Yeon Sil; Choi, Byung Ock; Kang, Young-Nam; Nam, Sang Hee; Park, Hyeong Wook; Kim, Shin Wook; Shin, Hun Joo; Lee, Jae Choon; Kim, Ji Na; Park, Sung Kwang; Kim, Jin Young

    2015-07-01

    The purpose of this study is to evaluate the clinical usefulness of modulated arc (mARC) treatment techniques. The mARC treatment plans for non-small-cell lung cancer (NSCLC) patients were made in order to verify the clinical usefulness of mARC. A pre-study was conducted to find the best plan condition for mARC treatment, and the usefulness of the mARC treatment plan was evaluated by comparing it with other Arc treatment plans such as tomotherapy and RapidArc plans. In the case of mARC, the optimal condition for the mARC plan was determined by comparing the dosimetric performance of the mARC plans developed by using various parameters, which included the photon energy (6 MV, 10 MV), the optimization point angle (6°- 10°intervals), and the total number of segments (36 - 59 segments). The best dosimetric performance of mARC was observed at a 10 MV photon energy, a point angle 6 degrees, and 59 segments. The treatment plans for the three different techniques were compared by using the following parameters: the conformity index (CI), homogeneity index (HI), the target coverage, the dose to the OARs, the number of monitor units (MU), the beam on time, and the normal tissue complication probability (NTCP). As a result, the three different treatment techniques showed similar target coverages. The mARC plan had the lowest V20 (volume of lung receiving > 20 Gy) and MU per fraction compared with both the RapidArc and the tomotherapy plans. The mARC plan reduced the beam on time as well. Therefore, the results of this study provide satisfactory evidence that the mARC technique can be considered as a useful clinical technique for radiation treatment.

  14. Clinical evaluation of liquid crystal skin thermometers.

    PubMed

    MacKenzie, R; Asbury, A J

    1994-02-01

    We have examined two types of liquid crystal thermometers (LCT) designed for clinical use: one designed to measure skin surface temperature (LCTS) and the other had its calibration shifted by 1.9 degrees C to read a "core" temperature (LCTC). In laboratory tests with LCT on a glass beaker, there were highly significant correlations between temperatures measured by thermocouples, LCTS (r = 0.99) and LCTC (r = 0.99). In five patients undergoing cooling and warming during cardiopulmonary bypass with an LCT on their forehead, next to a thermocouple, the smallest correlation coefficient was 0.92. In 7.3% of observations in patients, the LCT scale was blurred, but readable. The graph relating LCT temperature and forehead thermocouple temperature showed hysteresis between the cooling and warming phases. An additional laboratory experiment suggested that LCT might be affected by draughts; they should therefore be protected from draught in use.

  15. Evaluating clinical competence during nursing education: A comprehensive integrative literature review.

    PubMed

    Lejonqvist, Gun-Britt; Eriksson, Katie; Meretoja, Riitta

    2016-04-01

    This paper explored concepts, definitions and theoretical perspectives evaluating clinical competence during nursing education. The questions were: (i) How is clinical competence evaluated? and (ii) What is evaluated? An integrative review of 19 original research articles from 2009 to 2013 was performed. Results showed that evaluation tools were used in 14, observations in 2 and reflecting writing in 3 studies. The students participated in all but one evaluation alone or together with peers, faculty members or preceptors. Three themes were found: (i) professional practice with a caring perspective; (ii) clinical skills and reflective practice; and (iii) cognitive, affective and psychomotor skills both with a nursing perspective. This review shows an emphasis on structured methods with a risk reducing nursing to tasks and skills why combinations with qualitative evaluations are recommended. A holistic view of competence dominated and in designing evaluations, explicit perspectives and operationalized definitions of clinical competence became evident.

  16. Social Studies. Microsift Courseware Evaluations.

    ERIC Educational Resources Information Center

    Northwest Regional Educational Lab., Portland, OR.

    This compilation of 17 courseware evaluations gives a general overview of available social studies microcomputer courseware for students in grades 1-12. Each evaluation lists title, date, producer, date of evaluation, evaluating institution, cost, ability level, topic, medium of transfer, required hardware, required software, instructional…

  17. A comparative evaluation of plaque-removing efficacy of air polishing and rubber-cup, bristle brush with paste polishing on oral hygiene status: A clinical study

    PubMed Central

    Patil, Saurabh S.; Rakhewar, Purshottam S.; Limaye, Priyanka S.; Chaudhari, Niraj P.

    2015-01-01

    Objectives: Over the years, professional dental prophylaxis has involved the use of rubber-cup, bristle brush, and abrasive paste for coronal polishing. Although air polishing is an excellent alternative for removal of tooth stain and dental plaque, very few studies have compared their efficacy in vivo. The present study attempts to evaluate and compare the efficacy of air polishing (test) alone versus rubber-cup polishing (control). Materials and Methods: A total of 35 individuals having generalized mild to moderate gingivitis were enrolled as the study population after obtaining their informed consent. Before commencement of the study, all subjects underwent scaling to remove calculus deposits (if any), following which the ipsilateral quadrant of the patient's mouth was randomly assigned as the test side and the contralateral quadrant of the same arch was assigned as the control side for polishing procedures. Time employed for both methods of polishing was held constant at 5 min for each technique. Subjects were assessed before and immediately after polishing and again after 15 days following treatment, for plaque and gingival status along with gingival bleeding. Results: Overall, the results of the intra-group comparison of both the polishing procedure sites indicated similar but significant plaque and gingival status changes, whereas the inter-group comparison showed no significant difference between the efficacies of both the groups. Conclusions: Air polishing and the rubber-cup, bristle brush with paste polishing demonstrated equivalent efficacy regarding removal of supragingival plaque and in reducing gingival inflammation. PMID:26759798

  18. Does accountability for reasonableness work? A protocol for a mixed methods study using an audit tool to evaluate the decision-making of clinical commissioning groups in England

    PubMed Central

    Kieslich, Katharina; Littlejohns, Peter

    2015-01-01

    Introduction Clinical commissioning groups (CCGs) in England are tasked with making difficult decisions on which healthcare services to provide against the background of limited budgets. The question is how to ensure that these decisions are fair and legitimate. Accounts of what constitutes fair and legitimate priority setting in healthcare include Daniels’ and Sabin's accountability for reasonableness (A4R) and Clark's and Weale's framework for the identification of social values. This study combines these accounts and asks whether the decisions of those CCGs that adhere to elements of such accounts are perceived as fairer and more legitimate by key stakeholders. The study addresses the empirical gap arising from a lack of research on whether frameworks such as A4R hold what they promise. It aims to understand the criteria that feature in CCG decision-making. Finally, it examines the usefulness of a decision-making audit tool (DMAT) in identifying the process and content criteria that CCGs apply when making decisions. Methods and analysis The adherence of a sample of CCGs to criteria emerging from theories of fair priority setting will be examined using the DMAT developed by PL. The results will be triangulated with data from semistructured interviews with key stakeholders in the CCG sample to ascertain whether there is a correlation between those CCGs that performed well in the DMAT exercise and those whose decisions are perceived positively by interviewees. Descriptive statistical methods will be used to analyse the DMAT data. A combination of quantitative and qualitative content analysis methods will be used to analyse the interview transcripts. Ethics and dissemination Full ethics approval was received by the King's College London Biomedical Sciences, Dentistry, Medicine and Natural and Mathematical Sciences Research Ethics Subcommittee. The results of the study will be disseminated through publications in peer review journals. PMID:26163034

  19. 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

    NASA Technical Reports Server (NTRS)

    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.; Panza, Julio A.; Thomas, James D.

    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 <.001, delta = -0.91 +/- 2.65 mL). In patients, real-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 <.001, delta = -4.8 +/- 7.6 mL). CONCLUSIONS: real-time 3DCE can capture the entire FC image, permitting geometrical recognition of the FC zone geometry and reliable MR quantification.

  20. The evaluation of the clinical effect of topical St Johns wort (Hypericum perforatum L.) in plaque type psoriasis vulgaris: a pilot study.

    PubMed

    Najafizadeh, Parvaneh; Hashemian, Farshad; Mansouri, Parvin; Farshi, Susan; Surmaghi, Mohammadhossein Salehi; Chalangari, Reza

    2012-05-01

    In this case series, ten patients with plaque-type psoriasis were treated with Hypericum perforatum ointment. The hypericum ointment was applied to one side of each patient's body and the vehicle to the opposite side twice daily for 4 weeks in a single blinded manner. Modified psoriasis area severity index (PASI) scores were significantly lowered where the formulated ointment had been applied. In determining PASI scores, three factors, erythema, scaling and thickness, were evaluated; all were significantly lower where the formulated ointment had been applied (P = 0.01, P = 0.004, P = 0.04). Hypericum perforatum ointment applied twice daily may be effective in reducing PASI scores in mild plaque-type psoriasis, however, further larger studies need be conducted to achieve a more conclusive result.

  1. Evaluation of stream mining classifiers for real-time clinical decision support system: a case study of blood glucose prediction in diabetes therapy.

    PubMed

    Fong, Simon; Zhang, Yang; Fiaidhi, Jinan; Mohammed, Osama; Mohammed, Sabah

    2013-01-01

    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.

  2. A randomized clinical study for comparative evaluation of Aloe Vera and 0.2% chlorhexidine gluconate mouthwash efficacy on de-novo plaque formation

    PubMed Central

    Chhina, Shivjot; Singh, Avnish; Menon, Ipseeta; Singh, Rickypal; Sharma, Anubhav; Aggarwal, Vartika

    2016-01-01

    Objective: To comparatively assess the antiplaque efficacy of Aloe vera mouthwash and 0.2% chlorhexidine gluconate mouthwash on de novo plaque formation. Materials and Methods: This was a randomized, single blind, parallel, controlled clinical study with 90 healthy participants, with mean age of 27.19 ± 12.08 years. After thorough oral prophylaxis, participants were instructed to discontinue mechanical plaque control. Participants were divided randomly into three groups; pure Aloe vera mouthwash was dispensed to the test group; control group received 0.2% chlorhexidine gluconate mouthwash; in Placebo group, flavored distilled water was used as oral rinse twice daily. Effect on 4-day de novo plaque formation was assessed by comparing pre-rinsing Quigley Hein Modified Plaque Scores were analyzed statistically using analysis of variance and Student's t-test. Results: Post-rinsing control group showed the least plaque score which was comparable to the test group. Both the control group and test group showed significant difference with the placebo group. Conclusions: Herbal mouthwash containing Aloe vera mouthwash has comparable antiplaque efficacy as the gold standard 0.2% chlorhexidine gluconate with fewer side effects and can be considered as an alternative. PMID:27382543

  3. An integrated evaluation for the performance of clinical engineering department.

    PubMed

    Yousry, Ahmed M; Ouda, Bassem K; Eldeib, Ayman M

    2014-01-01

    Performance benchmarking have become a very important component in all successful organizations nowadays that must be used by Clinical Engineering Department (CED) in hospitals. Many researchers identified essential mainstream performance indicators needed to improve the CED's performance. These studies revealed mainstream performance indicators that use the database of a CED to evaluate its performance. In this work, we believe that those indicators are insufficient for hospitals. Additional important indicators should be included to improve the evaluation accuracy. Therefore, we added new indicators: technical/maintenance indicators, economic indicators, intrinsic criticality indicators, basic hospital indicators, equipment acquisition, and safety indicators. Data is collected from 10 hospitals that cover different types of healthcare organizations. We developed a software tool that analyses collected data to provide a score for each CED under evaluation. Our results indicate that there is an average gap of 67% between the CEDs' performance and the ideal target. The reasons for the noncompliance are discussed in order to improve performance of CEDs under evaluation.

  4. Evaluating an information system for medical care evaluation studies.

    PubMed

    Holloway, D C; Wiczai, L J; Carlson, E T

    1975-04-01

    The purpose of this study was to evaluate a computerized information system, the Professional Activity Study-Medical Audit Program (PAS-MAP), when used by the medical staff of a hospital to conduct medical care evaluation studies. PAS-MAP was compared to a manual system for collecting data not contained on the face sheets of medical records. The results indicated that, compared to the manual system, PAS-MAP: was less costly if more than 41 per cent of hospitalized patients were included in medical care evaluation studies; was as timely as the manual system for data it could provide but provided fewer clinical data elements than physicians requested; and was less protective against human error. Three decision makers assigned weights indicating the relative importance of these results. The weights were combined in an additive model to arrive at a score for each system. Based on these scores, the manual system was recommended for implementation.

  5. Computerized Ultrasound Risk Evaluation (CURE): First Clinical Results

    NASA Astrophysics Data System (ADS)

    Duric, N.; Littrup, P.; Rama, O.; Holsapple, E.

    The Karmanos Cancer Institute has developed an ultrasound (US) tomography system, known as Computerized Ultrasound Risk Evaluation (CURE), for detecting and evaluating breast cancer, with the eventual goal of providing improved differentiation of benign masses from cancer. We report on our first clinical findings with CURE.

  6. Evaluating clinical significance: incorporating robust statistics with normative comparison tests.

    PubMed

    van Wieringen, Katrina; Cribbie, Robert A

    2014-05-01

    The purpose of this study was to evaluate a modified test of equivalence for conducting normative comparisons when distribution shapes are non-normal and variances are unequal. A Monte Carlo study was used to compare the empirical Type I error rates and power of the proposed Schuirmann-Yuen test of equivalence, which utilizes trimmed means, with that of the previously recommended Schuirmann and Schuirmann-Welch tests of equivalence when the assumptions of normality and variance homogeneity are satisfied, as well as when they are not satisfied. The empirical Type I error rates of the Schuirmann-Yuen were much closer to the nominal α level than those of the Schuirmann or Schuirmann-Welch tests, and the power of the Schuirmann-Yuen was substantially greater than that of the Schuirmann or Schuirmann-Welch tests when distributions were skewed or outliers were present. The Schuirmann-Yuen test is recommended for assessing clinical significance with normative comparisons.

  7. Clinical evaluation of the overweight patient.

    PubMed

    Bray, G A; Ryan, D H

    2000-10-01

    Evaluation of an overweight patient is the first step in any therapeutic program. The syndromes of obesity can be classified in several ways. The first is an anatomic classification based on the size, number, and distribution of fat cells and fat tissue. The second is an etiologic classification based on identification of specific diseases and settings that produce obesity. Hypothalamic injury and endocrine disease such as Cushing's disease and the polycystic ovary syndrome are three identifiable causes of obesity. In this medicated society drugs are always candidates to produce weight gain. The most common causes, however, are stopping smoking, overconsumption of high-fat foods, a decrease in the level of activity, and aging. The natural history of obesity provides a useful framework in which to view both preventive and therapeutic strategies. Some individuals will never become overweight, but of those who do, about one-third will do so during the first two decades, and the remaining two-thirds will become overweight after age 20. A number of epidemiological and metabolic factors can serve as a guide to those individuals who are at high risk. Having overweight parents tops the list, but multiple births, cessation of smoking, and a sedentary lifestyle are additional factors. Therapeutic decisions should be based on risk-benefit decisions. The risk can be assessed from the body mass index, the distribution of fat in upper or lower body obesity, the rate of weight gain, and the degree of physical inactivity. After assessing risk, the therapeutic choices can be selected from the age category of the patient. With any therapeutic activity, involvement of the patient in a realistic approach to the treatment process is essential.

  8. Clinical audit of COPD in outpatient respiratory clinics in Spain: the EPOCONSUL study

    PubMed Central

    Calle Rubio, Myriam; Alcázar Navarrete, Bernardino; Soriano, Joan B; Soler-Cataluña, Juan J; Rodríguez González-Moro, José Miguel; Fuentes Ferrer, Manuel E; López-Campos, José Luis

    2017-01-01

    Background Chronic obstructive pulmonary disease (COPD) outpatients account for a large burden of usual care by respirologists. EPOCONSUL is the first national clinical audit conducted in Spain on the medical care for COPD patients delivered in outpatient respiratory clinics. We aimed to evaluate the clinical interventions and the degree of adherence to recommendations in outpatients of current COPD clinical practice guidelines. Methodology This is an observational study with prospective recruitment (May 2014–May 2015) of patients with a COPD diagnosis as seen in outpatient respiratory clinics. The information collected was historical in nature as for the clinical data of the last and previous consultations, and the information concerning hospital resources was concurrent. Results A total of 17,893 clinical records of COPD patients in outpatient respiratory clinics from 59 Spanish hospitals were evaluated. Of the 5,726 patients selected, 4,508 (78.7%) were eligible. Overall, 12.1% of COPD patients did not fulfill a diagnostic spirometry criteria. Considerable variability existed in the available resources and work organization of the hospitals, although the majority were university hospitals with respiratory inpatient units. There was insufficient implementation of clinical guidelines in preventive and educational matters. In contrast, quantitative evaluation of dyspnea grade (81.9%) and exacerbation history (70.9%) were more frequently performed. Only 12.4% had COPD severity calculated according to the Body mass index, airflow Obstruction, Dyspnoea and Exercise capacity (BODE) index. Phenotype characteristics according to Spanish National Guideline for COPD were determined in 46.3% of the audited patients, and the risk evaluation according to Global initiative for chronic Obstructive Lung Disease was estimated only in 21.9%. Conclusion The EPOCONSUL study reports the current situation of medical care for COPD patients in outpatient clinics in Spain, revealing

  9. A review of how the quality of HIV clinical services has been evaluated or improved.

    PubMed

    Hung, Anna; Pradel, Françoise

    2015-06-01

    To examine approaches being used to evaluate and improve quality of HIV clinical services we searched the MEDLINE, Cochrane Library collection, EMBASE, Global Health, and Web of Science databases for articles and abstracts focused on evaluating or improving quality of HIV clinical services. We extracted country income level, targeted clinical services, and quality evaluation approaches, data sources, and criteria. Fifty journal articles and 46 meeting abstracts were included. Of the 96 studies reviewed, 65% were programme evaluations, 71% focused on low- and middle-income countries, and 65% focused on antiretroviral therapy services. With regard to quality, 45% used a quality improvement model or programme, 13% set a quality threshold, and 51% examined patient records to evaluate quality. No studies provided a definition for quality HIV care. Quality assurance and improvement of HIV clinical services is increasingly important. This review highlights gaps in knowledge for future research, and may also help countries and programmes develop their HIV care quality improvement frameworks.

  10. Piezoelectric sensing: Evaluation for clinical investigation of deviated nasal septum

    PubMed Central

    Manjunatha, Roopa G.; Mahapatra, Roy D.; Dorasala, Srinivas

    2013-01-01

    Noninvasive objective evaluation of nasal airflow is one of the important clinical aspects. The developed polyvinylidene fluoride (PVDF) sensor enables measurement of airflow through each side of the nose using its piezoelectric property. This study was designed to evaluate the diagnostic capability of the PVDF sensor in assessing the deviated nasal septum (DNS). PVDF nasal sensor uses its piezoelectric property to measure the peak-to-peak amplitude (Vp-p) of nasal airflow in both of the nostrils: right nostril (RN) and left nostril (LN), separately and simultaneously. We have compared the results of PVDF nasal sensor, visual analog scale (VAS), and clinician scale for 34 DNS patients and 28 healthy controls. Additionally, the results were further analyzed by receiver operating characteristic curve and correlation between PVDF nasal sensor and VAS in detecting DNS. We found a significant difference in the peak-to-peak amplitude values of the test group and the control group. The correlation between the PVDF nasal sensor measurements and VAS (RN and LN combined) for test group was statistically significant (−0.807; p < 0.001). Sensitivity and specificity of the PVDF nasal sensor measurements in the detection of DNS (RN and LN combined) was 85.3 and 74.4%, respectively, with optimum cutoff value ≤0.34 Vp-p. The developed PVDF nasal sensor is noninvasive and requires less patient efforts. The sensitivity and specificity of the PVDF nasal sensor are reliable. According to our findings, we propose that the said PVDF nasal sensor can be used as a new diagnostic tool to evaluate the DNS in routine clinical practice. PMID:24498519

  11. Evaluation of the pharmacokinetics and pharmacodynamics of liposomal amikacin for inhalation in cystic fibrosis patients with chronic pseudomonal infections using data from two phase 2 clinical studies.

    PubMed

    Okusanya, Olanrewaju O; Bhavnani, Sujata M; Hammel, Jeffrey P; Forrest, Alan; Bulik, Catharine C; Ambrose, Paul G; Gupta, Renu

    2014-09-01

    The pharmacokinetic-pharmacodynamic (PK-PD) relationships between serum exposure measures of liposomal amikacin for inhalation (LAI) and the change in pulmonary function test (PFT) measures and number of CFU from baseline were evaluated in cystic fibrosis (CF) patients chronically infected with Pseudomonas aeruginosa. A dose of 70, 140, 280, or 560 mg of LAI or placebo was administered to CF patients once daily for 28 days. PFTs and sputum samples for microbiology were assessed on days 7, 14, 21, 28, 35 (for log10 CFU), and 56 (for PFTs). Serum, urine, and sputum samples were collected for PK evaluation. The relationships between efficacy endpoints (relative change in forced expiratory volume in 1 s [FEV1 {expressed in liters}] and FEV1% predicted and the absolute change in log10 CFU of P. aeruginosa from baseline) and exposure measures (dose, day 1 area under the curve [AUC], dose/MIC ratio, and day 1 AUC/MIC ratio) and baseline MIC value were assessed. The serum and urine PK data were best fit by a 3-compartment model (lung, serum, and urine) with linear clearance and interoccasional variation on total and renal clearance. Significant univariable relationships between dose or day 1 AUC and the relative change in PFT measures (P≤0.017) or the absolute change in log10 CFU from baseline (P≤0.037) on the study days were identified. Repeated-measures mixed-effects models, which showed dose- and AUC-related improvements for each efficacy endpoint (P≤0.041), predicted the observed data well. The increases in the relative change in FEV1 and FEV1% predicted of 11% and 9.9%, respectively, and a 1.23-log10 CFU reduction per 560 mg of LAI estimated on day 7 were comparable to the observed increases of 10.7% and 10.3%, respectively, and a 1.24-log10 CFU reduction on the same day. The model-estimated PFT effects were predicted to be sustained to day 28. An additional 0.451-log10 CFU reduction (P=0.022) was estimated on day 14 relative to day 7, with a persistence of

  12. Clinical evaluation of disc battery ingestion in children.

    PubMed

    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.

  13. Evaluation of the Clinical Decisions Made for 2-Year-Olds Referred for Speech and Language Therapy: A Follow-Up Study

    ERIC Educational Resources Information Center

    Emanuel, Rosemary; Chiat, Shula; Roy, Penny

    2007-01-01

    Background: Clinicians in the UK rely mainly on informal observations and structured and semi-structured tasks rather than standardized testing in their assessments of pre-school children referred with speech and language difficulties. The informal nature of the clinical decision-making process at this age is unsurprising given the dearth of…

  14. 78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-01

    ... ``Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain... facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the IDE regulations. Early feasibility studies allow for limited early clinical evaluations of...

  15. Quantitative study of liver magnetic resonance spectroscopy quality at 3T using body and phased array coils with physical analysis and clinical evaluation.

    PubMed

    Xu, Li; Gu, Shiyong; Feng, Qianjin; Liang, Changhong; Xin, Sherman Xuegang

    2015-01-01

    This study aims to investigate the quality difference of short echo time (TE) breathhold 1H magnetic resonance spectroscopy (MRS) of the liver at 3.0T using the body and phased array coils, respectively. In total, 20 pairs of single-voxel proton spectra of the liver were acquired at 3.0T using the phased array and body coils as receivers. Consecutive stacks of breathhold spectra were acquired using the point resolved spectroscopy (PRESS) technique at a short TE of 30 ms and a repetition time (TR) of 1500 ms. The first spectroscopy sequence was "copied" for the second acquisition to ensure identical voxel positioning. The MRS prescan adjustments of shimming and water suppression, signal-to noise ratio (SNR), and major liver quantitative information were compared between paired spectra. Theoretical calculation of the SNR and homogeneity of the region of interest (ROI, 2 cm×2 cm×2 cm) using different coils loaded with 3D liver electromagnetic model of real human body was implemented in the theoretical analysis. The theoretical analysis showed that, inside the ROI, the SNR of the phase array coil was 2.8387 times larger than that of body coil and the homogeneity of the phase array coil and body coil was 80.10% and 93.86%, respectively. The experimental results showed excellent correlations between the paired data (all r > 0.86). Compared with the body coil group, the phased array group had slightly worse shimming effect and better SNR (all P values < .01). The discrepancy of the line width because of the different coils was approximately 0.8 Hz (0.00625 ppm). No significant differences of the major liver quantitative information of Cho/Lip2 height, Cho/Lip2 area, and lipid content were observed (all P values >0.05). The theoretical analysis and clinical experiment showed that the phased array coil was superior to the body coil with respect to 3.0T breathhold hepatic proton MRS.

  16. [Clinical and pharmacokinetic evaluation of ceftazidime in children].

    PubMed

    Fujita, K; Sakata, H; Murono, K; Yoshioka, H; Maruyama, S; Sanae, N; Takimoto, M

    1984-03-01

    Forty-two pediatric patients were treated with ceftazidime ( CAZ ) in the doses ranging from 45.6 to 120 mg/kg/day for 2 to 10 days, and the clinical efficacy and side effects were evaluated. Among the 37 children with bacterial infections including pneumonia, bronchitis, tonsillitis, croup, cervical lymphadenitis, abdominal abscess and urinary tract infections, the results were excellent in 22, good in 12, fair in 2, and poor in 1 patient with pneumonia. Out of the 42 patients, 5 cases showed eosinophilia, but no clinical sign such as rash, fever or diarrhea, attributable to CAZ was observed during the study. The serum concentrations of CAZ in 4 patients ranged from 60.8 to 71.0 micrograms/ml (mean 66.1 micrograms/ml) at 30 minutes and from 0.5 to 1.2 micrograms/ml (mean 0.8 micrograms/ml) at 8 hours after 20 mg/kg intravenous bolus injection of the antibiotic. The mean serum half-life was 1.42 hours (85 minutes). Patients with impairment of renal function were excluded from this study.

  17. [Evaluation of clinical evidence for dalbavancin].

    PubMed

    Rodríguez-Pardo, Dolors

    2017-01-01

    Gram-positive infections are currently a therapeutic challenge because of the emergence of strains resistant to first-line antibiotics. Consequently, in the last few years, new antibiotics have been developed with activity against multiresistant Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus and strains with intermediate sensitivity to vancomycin. Among the new antibiotics approved for the treatment of these microorganisms, dalbavancin is a semisynthetic lipoglycopeptide derived from teicoplanin, but has a superior efficacy profile to the latter. Studies published to date have confirmed the efficacy, safety and tolerability of dalbavancin in the treatment of skin and soft tissue infections caused by Gram-positive microorganisms sensitive to this drug and position it as a therapeutic option in Gram-positive catheter-related sepsis. Dalbavancin has an excellent safety profile and pharmacokinetics that allow its intravenous administration in a single weekly dose, making it a therapeutic option for outpatient use. Dalbavancin could also be an attractive alternative for patients requiring prolonged antibiotic therapy, with the aim of avoiding the need for a permanent intravenous line and its associated risks, such as infection and/or septic thrombophlebitis.

  18. Evaluation of Gengigel® Application in the Management of Furcation with Coronally Advanced Flap through Surgical Re-Entry-A Split Mouth Clinical Study

    PubMed Central

    Gupta, Sugandha; Kediege, Suresh D; Gupta, Akanksha

    2017-01-01

    Introduction One of the challenging and unique periodontal problem of Grade II furcation defect has been managed through different treatment modalities in the past. A successful approach is based on complete closure of the defect. Different regenerative approaches have been tried. Aim This study was carried out with an aim to evaluate the role of Gengigel® (0.8% hyaluronic acid) as a potential material for regeneration of lost attachment apparatus. Materials and Methods A total of 20 sites with Grade II furcation defects from 10 patients were selected using random sampling technique. These were divided into Group A (placement of hyaluronic acid) and Group B (without placement of hyaluronic acid) according to treatment modality. Furcation defect assessment was done in vertical and horizontal depth preoperatively and postoperatively at six months through surgical re-entry. Recorded data was subjected to the statistical analysis unpaired and paired t-tests for intergroup and intragroup comparisons respectively. Results Mean plaque index, gingival index and bleeding index score showed statistically highly significant and significant results respectively, for both the groups at baseline and six months. Mean difference in probing pocket depth and Relative Attachment Level (RAL) were statistically highly significant, whereas, mean difference of gingival position margin was non significant for both the groups, at baseline and six months. Mean difference in horizontal component at baseline and six months was statistically highly significant for both the groups. Mean difference in vertical component at baseline and six months was statistically significant for both the groups. On comparison, the mean difference in vertical and horizontal component of Group A and Group B at six months was statistically not significant. conclusion Both Gengigel® with coronally positioned flap and coronally positioned flap alone are effective in the treatment of Grade II furcation defects. The

  19. Clinical evaluation of chlorine dioxide for disinfection of dental instruments.

    PubMed

    Watamoto, Takao; Egusa, Hiroshi; Sawase, Takashi; Yatani, Hirofumi

    2013-01-01

    This study aimed to clinically evaluate the disinfection efficacy of chlorine dioxide (ClO2) for used dental instruments. An imprint culture technique demonstrated that ultrasonic cleaning of intraorally applied dental mirrors in 0.02% ClO2 for 10 minutes resulted in compete removal of microorganisms for 10 subjects. Hepatitis C virus (HCV) RNA was detected by real-time polymerase chain reaction on periodontal curettes after subgingival scaling in four HCV-infected patients and was completely removed by the same treatment procedure. Therefore, the combination of ultrasonic cleaning with ClO2 may provide an alternative to toxic disinfectants, such as glutaraldehyde and sodium hypochlorite, for disinfecting dental instruments.

  20. [Clinical evaluation of thrombo-embolic venous disease].

    PubMed

    Chagnon, Isabelle

    2003-01-01

    Clinical manifestations of venous thromboembolism are often subtle or misleading. Yet it is a potentially fatal condition. Although the symptoms and signs at presentation have a poor sensitivity and specificity when considered singly, the physician can accurately assess a clinical probability based on the history, the risk factors, the physical examination and some simple laboratory exams. This essential step allows us to identify a low risk group of patients which will benefit of a non invasive diagnostic strategy. More recently explicit prediction rules were proposed to offset the lack of standardization of this clinical assessment. These new didactic tools can simplify clinical evaluation. Nevertheless, their comparison to implicit evaluation reveals that they should be complemented by the physician's judgement.

  1. Evaluation of the Olympus AU 400 clinical chemistry analyzer.

    PubMed

    Bilić, A; Alpeza, I; Rukavina, A S

    2000-01-01

    The performance of the Olympus AU 400 clinical chemistry analyzer was evaluated according to the guidelines of the European Committee for Clinical Laboratory Standards. The following analytes were tested: glucose, urea, creatinine, calcium, AST, ALT, CK, LDH, ALP and amylase. The Olympus AU 400 was compared with the Olympus AU 800. Coefficients of correlation showed high correlation between the compared analyzers. Other performances (intra- and inter-assay variation, carry-over and interferences) of the analyzer were satisfactory.

  2. A "three-plus-one" evaluation model for clinical research management.

    PubMed

    Dilts, David M

    2013-12-01

    Clinical research management (CRM) is a critical resource for the management of clinical trials and it requires proper evaluation. This article advances a model of evaluation that has three local levels, plus one global level, for evaluating the value of CRM. The primary level for evaluation is that of the study or processes level. The managerial or aggregate level concerns management of the portfolio of trials under the control of the CRM office. The third, often overlooked level of evaluation, is the strategic level, whose goal is encapsulated in the phrase, "doing the right trials, while doing trials right." The global ("plus one") evaluation level concerns the need to evaluate the ever-increasing number of multi-institutional and multinational studies. As there are host of evaluation metrics, this article provides representative examples of metrics at each level and provides methods that can aid in the selecting appropriate metrics for an organization.

  3. Evaluation of the Konelab 20XT clinical chemistry analyzer.

    PubMed

    Stojanović, Natasa; Rogić, Dunja; Stavljenić-Rukavina, Ana

    2005-01-01

    The Konelab 20XT (Thermo Electron Oy, Finland) is a clinical chemistry analyzer for colorimetric, immunoturbidimetric and ion-selective electrode measurements. The aim of our work was to evaluate the analytical performances of the Konelab 20XT according to the European Clinical Chemistry Laboratory Standards Guidelines. A total of 30 analytes including substrates, enzymes, electrolytes and specific proteins were tested. Investigation results showed low imprecision (within-run coefficient of variation was below 3.5% and between-day coefficient of variation was less than 2.5% for most analytes at all three levels studied) and acceptable accuracy of the analyzer. No significant sample- or reagent-related carry-over was found. It was demonstrated that the analytical system operates within the claimed linearity ranges. The results compared well with those obtained by instruments routinely used in our laboratory (Olympus AU2700, Behring Nephelometer II). In general, the data on interference by hemoglobin, hyperbilirubinemia and turbidity are in accordance with known facts. However, slight hemolysis was found to interfere with the alkaline phosphatase (ALP) assay and mild lipemia affected the glucose assay. The Konelab 20XT is an easy-to-use analyzer that is suitable for routine and emergency analyses in small laboratories.

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

    PubMed

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

    2016-10-01

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

  5. Smith-Magenis syndrome: clinical evaluation in seven Brazilian patients.

    PubMed

    Gamba, B F; Vieira, G H; Souza, D H; Monteiro, F F; Lorenzini, J J; Carvalho, D R; Morreti-Ferreira, D

    2011-10-31

    Smith-Magenis syndrome (SMS) is a complex congenital anomaly characterized by craniofacial anomalies, neurological and behavioral disorders. SMS is caused by a deletion in region 17p11.2, which includes the RAI1 gene (90% of cases), or by point mutation in the RAI1 gene (10% of cases). Laboratory diagnosis is through cytogenetic analysis by GTG banding and molecular cytogenetic analysis by FISH. We carried out an active search for patients in Associations of Parents and Friends of Exceptional Children (APAE) of São Paulo and genetic centers in Brazil. Forty-eight patients were screened for mental retardation, craniofacial abnormalities and stereotyped behavior with a diagnosis of SMS. In seven of them, chromosome banding at high resolution demonstrated chromosome 17p11.2 deletions, confirmed by FISH. We also made a meta-analysis of 165 cases reported between 1982 and 2010 to compare with the clinical data of our sample. We demonstrated differences between the frequencies of clinical signs among the cases reported and seven Brazilian cases of this study, such as dental anomalies, strabismus, ear infections, deep hoarse voice, hearing loss, and cardiac defects. Although the gold standard for diagnosis of SMS is FISH, we found that the GTG banding technique developed to evaluate chromosome 17 can be used for the SMS diagnosis in areas where the FISH technique is not available.

  6. Preparedness for clinical: evaluation of the core elements of the Clinical Immersion curriculum model.

    PubMed

    Diefenbeck, Cynthia; Herrman, Judith; Wade, Gail; Hayes, Evelyn; Voelmeck, Wayne; Cowperthwait, Amy; Norris, Susan

    2015-01-01

    The Clinical Immersion Model is an innovative baccalaureate nursing curriculum that has demonstrated successful outcomes over the past 10 years. For those intending to adopt the model, individual components in isolation may prove ineffective. This article describes three core components of the curriculum that form the foundation of preparation for the senior-year clinical immersion. Detailed student-centered outcomes evaluation of these critical components is shared. Results of a mixed-methods evaluation, including surveys and focus groups, are presented. Implications of this curricular evaluation and future directions are explored.

  7. [Purine metabolism in ankylosing spondylitis: clinical study].

    PubMed

    Jiménez Balderas, F J; Robles, E J; Juan, L; Badui, E; Arellano, H; Espinosa Said, L; Mintz Spiro, G

    1989-01-01

    We undertook a prospective study of 23 male patients with Ankylosing Spondylitis (AS) (New York Criteria), 18 HLA-B27 positive and 5 HLA-B27 negative, five of them had hyperuricemia. The following data of evolution were taken into consideration: age at onset of disease, time course of the disease, presence of urolithiasis, heart disease, flares of uveitis. Clinical activity and degree of disability were evaluated every one to 3 months; on each visit, every patient had determinations of serum and urinary uric acid levels, serum and phosphorus, erythrocyte sedimentation rate (ESR), serum protein electrophoresis, as well as X-ray films of the vertebral spine and pelvis. Three groups of patients were detected, all of them with equal age at onset, duration of disease, frequency of B27, peripheral arthritis, and leukocytosis. One group had hyperuricemia (5 of 23 patients, 80% of them HLA-B27 positive) and a lesser degree of clinical activity of the disease (p less than .001, a higher frequency of uveitis (40%, lower levels of serum gammaglobulins (p less than 0.05) and ESR (p less than 0.05), a lesser degree of ankylosis of the spine, and a better functional prognosis than the other groups. Another group (8 of 23 patients, 75% of them were HLA-B27 positive) had normouricemia and hyperuricosuria, and showed a higher frequency of fever (50%), an abnormal urinalysis, and urolithiasis (25%).

  8. An overview of clinical studies on fiber post systems.

    PubMed

    Dikbas, Idil; Tanalp, Jale

    2013-01-01

    Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis.

  9. Statistical Issues in TBI Clinical Studies

    PubMed Central

    Rapp, Paul E.; Cellucci, Christopher J.; Keyser, David O.; Gilpin, Adele M. K.; Darmon, David M.

    2013-01-01

    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 non-responders requires, minimally, a two phase investigation. This procedure must include a mechanism to

  10. Tuberculosis care: an evaluability study

    PubMed Central

    Coelho, Ardigleusa Alves; Martiniano, Cláudia Santos; Brito, Ewerton Willian Gomes; Negrão, Oswaldo Gomes Corrêa; Arcêncio, Ricardo Alexandre; Uchôa, Severina Alice da Costa

    2014-01-01

    OBJECTIVE: to verify whether the tuberculosis control program (TCP) is evaluable and to examine the feasibility of building an evaluation model in apriority municipality for the control of tuberculosis. METHOD: this evaluability study was conducted in a municipality in northeastern Brazil. For data collection, documental analysis and interviews with key informants were performed. For indicator validation, the nominal group technique was adopted. RESULTS: the details of TCP were described, and both the logical model and the classification framework for indicators were developed and agreed up on, with the goal of characterizing the structural elements of the program, defining the structure and process indicators, and formulating the evaluation questions. CONCLUSION: TCP is evaluable. Based on logical operational analysis, it was possible to evaluate the adequacy of the program goals for the control of tuberculosis. Therefore, the performance of a summative evaluation is recommended, with a focus on the analysis of the effects of tuberculosis control interventions on decreasing morbidity and mortality. PMID:25493675

  11. Clinical evaluation of a new technique for interdental enamel reduction.

    PubMed

    Zhong, M; Jost-Brinkmann, P G; Zellmann, M; Zellmann, S; Radlanski, R J

    2000-01-01

    In orthodontics, reduction of tooth-size by grinding interproximal surfaces (stripping) of teeth is a common procedure. In order to achieve perfectly smooth surfaces, clinicians have carefully tested various methods and progressively improved this therapeutic procedure. In this in-vivo study we used scanning electron microscopy (SEM) to evaluate the morphologic effect of a 3-step technique using an oscillating perforated diamond-coated disc for enamel reduction and 2 Sof-Lex XT discs for polishing. This technique was applied in 32 patients with an average age of 15.5 years. A total of 296 interproximal surfaces was treated and replicas were produced for scanning electron microscopy evaluation. The scanning electron microscopy investigations demonstrated that more than 90% of the reproximated surfaces were very well or well polished, resulting in polished enamel surfaces smoother than untreated enamel. This technique proved to be clinically expedient as it finished each interproximal surface within about 2.2 minutes. At the same time, it was demonstrated to be safe and comfortable for the patient, eliminating the need for lip or cheek protectors and making injuries unlikely.

  12. Clinical Validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62): Further Evaluation and Clinical Applications

    ERIC Educational Resources Information Center

    McAleavey, Andrew A.; Nordberg, Samuel S.; Hayes, Jeffrey A.; Castonguay, Louis G.; Locke, Benjamin D.; Lockard, Allison J.

    2012-01-01

    Self-report instruments of psychological symptoms are increasingly used in counseling centers but rely on rigorous evaluation of their clinical validity. Three studies reported here (total N = 26,886) investigated the validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62; Locke et al., 2011) as an assessment and…

  13. Evaluation of the technical variations and the suitability of a hydrophilic interaction liquid chromatography-high resolution mass spectrometry (ZIC-pHILIC-Exactive orbitrap) for clinical urinary metabolomics study.

    PubMed

    Zhang, Tong; Watson, David G

    2016-06-01

    Although many hydrophilic interaction liquid chromatography-high resolution mass spectrometry (HILIC-HRMS) methods have been developed and applied for untargeted metabolite profiling in clinical metabolomics, according to the literature, the suitability of these HILIC-HRMS methods has not been fully evaluated with respect to their performance when they are subjected to statistical analysis. In this study, using a series of human urine samples we investigated the effect of technical variations on multivariate and univariate analysis of the data collected using a previously developed HILIC-HRMS method for untargeted urinary metabolite profiling in clinical metabolomics. The technical variation introduced by sample preparation was more significant than that produced by the HILIC-HRMS method. By using an orthogonal partial least squares (OPLS) model, subtle fold-changes were accurately measured in the urine samples spiked with (13)C and (15)N isotope labelled amino acids at different concentrations. The robustness of this HILIC method was also evaluated by analysing the obtained data from a single urine sample following manipulation of several primary LC parameters. High reproducibility in the chromatographic performance of three ZIC-pHILIC columns with different batch numbers indicated the reliability of the polymer based zwitterionic stationary phase allowing column replacement without compromising the performance of the method.

  14. Evaluation of effectiveness of hyaluronic acid in combination with bioresorbable membrane (poly lactic acid-poly glycolic acid) for the treatment of infrabony defects in humans: A clinical and radiographic study

    PubMed Central

    Sehdev, Bhumika; Bhongade, Manohar Laxmanrao; Ganji, Kiran Kumar

    2016-01-01

    Background: The combination of biomaterials, bone graft substitutes along with guided tissue regeneration (GTR) has been shown to be an effective modality of periodontal regenerative therapy for infrabony defects. Therefore, the present randomized controlled clinical study was undertaken to evaluate the effectiveness of hyaluronic acid (HA) in combination with bioresorbable membrane for the treatment of human infrabony defects. Materials and Methods: Twenty four infrabony defects in 20 systemically healthy patients were randomly assigned to test (HA in combination with bioresorbable membrane) and control (bioresorbable membrane alone) treatment groups. Probing pocket depth (PPD), relative attachment level, and relative gingival margin level were measured with a computerized Florida disc probe at baseline and at 6 months follow-up. Radiographic measurements were also evaluated at baseline and at 6 months of postsurgery. Results: At 6 months, the mean reduction in PPD in test group and control group was 4.52 mm and 2.97 mm, respectively. Significantly higher clinical attachment level with a gain of 2.20 mm was found in the test group as compared to control group. In addition, statistically significant greater reduction of radiographic defect depth was observed in the test group. Conclusion: Regenerative approach using hyaloss in combination with GTR for the treatment of human infrabony defects resulted in a significant added benefit in terms of CAL gains, PPD reductions and radiographic defect fill, as well as LBG, compared to the GTR alone. PMID:27041838

  15. [Postmarketing herbs clinical evaluation should concern about re-evaluating symptoms].

    PubMed

    He, Wei; Xie, Yanming; Wang, Yongyan

    2010-06-01

    Re-evaluation of premarketing medicine is a important supplementary of clinical and elementary research. It is a basement that establish the medicine administration supervisition , found and integrity postmarketing washing out mechanism and define reasonable using drug. After drug marketing, we must not only concern on the re-evaluation of herbs security but also focus on evaluating herbs suitable symptom, as well as its dosage and course of treatment, ect. The re-evaluation of symptoms were seen as the core and feature of traditional Chinese medicine's clinical evaluation. It is also seen as hot spot and difficulty of the research . This article try to focus on simply illustrating the necessity and research thinking of re-evaluation symptoms of postmarketing herbs. So we can define the re-evaluation of postmarketing drug's objection, method, and basement. It will provide beneficial experience and reference to re-evaluation symptom of marketed herbs.

  16. A General Framework for the Evaluation of Clinical Trial Quality

    PubMed Central

    Berger, Vance W.; Alperson, Sunny Y.

    2009-01-01

    Flawed evaluation of clinical trial quality allows flawed trials to thrive (get funded, obtain IRB approval, get published, serve as the basis of regulatory approval, and set policy). A reasonable evaluation of clinical trial quality must recognize that any one of a large number of potential biases could by itself completely invalidate the trial results. In addition, clever new ways to distort trial results toward a favored outcome may be devised at any time. Finally, the vested financial and other interests of those conducting the experiments and publishing the reports must cast suspicion on any inadequately reported aspect of clinical trial quality. Putting these ideas together, we see that an adequate evaluation of clinical quality would need to enumerate all known biases, update this list periodically, score the trial with regard to each potential bias on a scale of 0% to 100%, offer partial credit for only that which can be substantiated, and then multiply (not add) the component scores to obtain an overall score between 0% and 100%. We will demonstrate that current evaluations fall well short of these ideals. PMID:19463104

  17. Chairside Assisting Skill Evaluation (CASE). Clinical Setting. Health Manpower References.

    ERIC Educational Resources Information Center

    Innovative Programming Systems, Minneapolis, Minn.

    These checklists are designed for use during the dental assistant student's extramural clinical experience assignment. Checklists test students on their knowledge of terminology, equipment, procedures, and patient relations. Objectives are listed outline style with columns to check progress during a first and a second evaluation. Areas included…

  18. Development of a New O&M Clinical Competency Evaluation Tool and Examination of Validity and Reliability Evidence

    ERIC Educational Resources Information Center

    Renshaw, Rebecca L.

    2010-01-01

    The goal of this study was to create an evaluation tool that would be the new standard for evaluating clinical competencies of interns in the field of orientation and mobility (O&M). Using results from previous research in this area, specific competency skills were identified and the O&M Clinical Competency Evaluation Matrix (CCEM) was…

  19. [Discussion on development of four diagnostic information scale for clinical re-evaluation of postmarketing herbs].

    PubMed

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-12-01

    Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.

  20. Evaluation of a novel electronic genetic screening and clinical decision support tool in prenatal clinical settings.

    PubMed

    Edelman, Emily A; Lin, Bruce K; Doksum, Teresa; Drohan, Brian; Edelson, Vaughn; Dolan, Siobhan M; Hughes, Kevin; O'Leary, James; Vasquez, Lisa; Copeland, Sara; Galvin, Shelley L; DeGroat, Nicole; Pardanani, Setul; Gregory Feero, W; Adams, Claire; Jones, Renee; Scott, Joan

    2014-07-01

    "The Pregnancy and Health Profile" (PHP) is a free prenatal genetic screening and clinical decision support (CDS) software tool for prenatal providers. PHP collects family health history (FHH) during intake and provides point-of-care risk assessment for providers and education for patients. This pilot study evaluated patient and provider responses to PHP and effects of using PHP in practice. PHP was implemented in four clinics. Surveys assessed provider confidence and knowledge and patient and provider satisfaction with PHP. Data on the implementation process were obtained through semi-structured interviews with administrators. Quantitative survey data were analyzed using Chi square test, Fisher's exact test, paired t tests, and multivariate logistic regression. Open-ended survey questions and interviews were analyzed using qualitative thematic analysis. Of the 83% (513/618) of patients that provided feedback, 97% felt PHP was easy to use and 98% easy to understand. Thirty percent (21/71) of participating physicians completed both pre- and post-implementation feedback surveys [13 obstetricians (OBs) and 8 family medicine physicians (FPs)]. Confidence in managing genetic risks significantly improved for OBs on 2/6 measures (p values ≤0.001) but not for FPs. Physician knowledge did not significantly change. Providers reported value in added patient engagement and reported mixed feedback about the CDS report. We identified key steps, resources, and staff support required to implement PHP in a clinical setting. To our knowledge, this study is the first to report on the integration of patient-completed, electronically captured and CDS-enabled FHH software into primary prenatal practice. PHP is acceptable to patients and providers. Key to successful implementation in the future will be customization options and interoperability with electronic health records.

  1. A clinical evaluation denture adhesives used by patients with xerostomia.

    PubMed

    Bogucki, Zdzislaw A; Napadlek, Piotr; Dabrowa, Tomasz

    2015-02-01

    The purpose of study was to analyze the participants' opinions concerning the effectiveness of 6 denture adhesives (DA). The study group included 60 participants. Criteria for selecting the patients were as follows: reduced retention and stabilization of maxillary complete dentures and xerostomia. These features were evaluated on basis of clinical examination and standard sialometry tests (u-SFR). Retention of maxillary dentures was scored by modified Kapur index before application of DA. All participants were divided randomly into 6 groups regarding the use of the 6 DA during a 6-month period. After this time, participants completed an HRQL questionnaire. DA noticeably improved retention and stabilization of maxillary complete dentures. DA in the glue form had the best retention effectiveness in participants with xerostomia. These materials are difficult to clean from the denture base. The data are presented in tables and figures. The results of the study collected positive influence of adhesives on retention of dentures in xerostomia patients. The cleaning dentures and denture bearing tissues was difficult. DA help in the use of prostheses, but it is also necessary for the treatment of the causes and symptoms of xerostomia.

  2. A Clinical Evaluation Denture Adhesives Used by Patients With Xerostomia

    PubMed Central

    Bogucki, Zdzislaw A.; Napadlek, Piotr; Dabrowa, Tomasz

    2015-01-01

    Abstract The purpose of study was to analyze the participants’ opinions concerning the effectiveness of 6 denture adhesives (DA). The study group included 60 participants. Criteria for selecting the patients were as follows: reduced retention and stabilization of maxillary complete dentures and xerostomia. These features were evaluated on basis of clinical examination and standard sialometry tests (u-SFR). Retention of maxillary dentures was scored by modified Kapur index before application of DA. All participants were divided randomly into 6 groups regarding the use of the 6 DA during a 6-month period. After this time, participants completed an HRQL questionnaire. DA noticeably improved retention and stabilization of maxillary complete dentures. DA in the glue form had the best retention effectiveness in participants with xerostomia. These materials are difficult to clean from the denture base. The data are presented in tables and figures. The results of the study collected positive influence of adhesives on retention of dentures in xerostomia patients. The cleaning dentures and denture bearing tissues was difficult. DA help in the use of prostheses, but it is also necessary for the treatment of the causes and symptoms of xerostomia. PMID:25700320

  3. COMPUTATIONAL MITRAL VALVE EVALUATION AND POTENTIAL CLINICAL APPLICATIONS

    PubMed Central

    Chandran, Krishnan B.; Kim, Hyunggun

    2014-01-01

    The mitral valve (MV) apparatus consists of the two asymmetric leaflets, the saddle-shaped annulus, the chordae tendineae, and the papillary muscles. MV function over the cardiac cycle involves complex interaction between the MV apparatus components for efficient blood circulation. Common diseases of the MV include valvular stenosis, regurgitation, and prolapse. MV repair is the most popular and most reliable surgical treatment for early MV pathology. One of the unsolved problems in MV repair is to predict the optimal repair strategy for each patient. Although experimental studies have provided valuable information to improve repair techniques, computational simulations are increasingly playing an important role in understanding the complex MV dynamics, particularly with the availability of patient-specific real-time imaging modalities. This work presents a review of computational simulation studies of MV function employing finite element (FE) structural analysis and fluid-structure interaction (FSI) approach reported in the literature to date. More recent studies towards potential applications of computational simulation approaches in the assessment of valvular repair techniques and potential pre-surgical planning of repair strategies are also discussed. It is anticipated that further advancements in computational techniques combined with the next generations of clinical imaging modalities will enable physiologically more realistic simulations. Such advancement in imaging and computation will allow for patient-specific, disease-specific, and case-specific MV evaluation and virtual prediction of MV repair. PMID:25134487

  4. Systematic evaluation of the clinical effects of supportive mistletoe treatment within chemo- and/or radiotherapy protocols and long-term mistletoe application in nonmetastatic colorectal carcinoma: multicenter, controlled, observational cohort study.

    PubMed

    Friedel, Walter E; Matthes, Harald; Bock, Paul R; Zänker, Kurt S

    2009-01-01

    In Europe, patients with colorectal carcinoma (CRC) frequently receive mistletoe extracts to improve quality of life and survival. This study was designed to evaluate supportive treatment with mistletoe extract Iscador (ISC) in nonmetastatic CRC patients under routine clinical conditions and to create well-founded hypotheses for future prospective clinical studies. The design of a multicenter, controlled, retrospective, observational cohort study with parallel groups met the Good Epidemiological Practice rules. Anonymous unselected standardized data from eligible patients with surgically treated stage I-III CRC and adjuvant therapy (AT) or conventional aftercare were included. End points were adjuvant therapy-related adverse reactions (AT-ADRs), symptoms, and disease-free survival (DFS). The results were adjusted for confounder effects. Eight hundred four (429 ISC vs 375 control) CRC patients from 26 centers were observed for a median of 58 versus 51 months; the median ISC therapy lasted 52 months. ISC patients showed fewer AT-ADRs (19% vs 48%, p < .001) and fewer persisting symptoms (p < .001). The DFS hazard ratio of 0.60 (p = .013) suggests a survival benefit in ISC patients versus controls. ISC was well tolerated without life-threatening ADRs, drug interactions, or tumor enhancement. These results suggest a beneficial effect of supportive care ISC therapy within AT protocols and long-term ISC treatment in stage I-III CRC patients, particularly improvement in AT-ADRs and symptoms and possible extension of DFS.

  5. Learning from epidemiological, clinical, and immunological studies on Mycobacterium africanum for improving current understanding of host-pathogen interactions, and for the development and evaluation of diagnostics, host-directed therapies, and vaccines for tuberculosis.

    PubMed

    Zumla, Alimuddin; Otchere, Isaac Darko; Mensah, Gloria Ivy; Asante-Poku, Adwoa; Gehre, Florian; Maeurer, Markus; Bates, Matthew; Mwaba, Peter; Ntoumi, Francine; Yeboah-Manu, Dorothy

    2017-03-01

    Mycobacterium africanum comprises two phylogenetic lineages within the Mycobacterium tuberculosis complex (MTBC). M. africanum was first described and isolated in 1968 from the sputum of a Senegalese patient with pulmonary tuberculosis (TB) and it has been identified increasingly as an important cause of human TB, particularly prevalent in West Africa. The restricted geographical distribution of M. africanum, in contrast to the widespread global distribution of other species of MTBC, requires explanation. Available data indicate that M. africanum may also have important differences in transmission, pathogenesis, and host-pathogen interactions, which could affect the evaluation of new TB intervention tools (diagnostics and vaccines)-those currently in use and those under development. The unequal geographical distribution and spread of MTBC species means that individual research findings from one country or region cannot be generalized across the continent. Thus, generalizing data from previous and ongoing research studies on MTBC may be inaccurate and inappropriate. A major rethink is required regarding the design and structure of future clinical trials of new interventions. The West, Central, East, and Southern African EDCTP Networks of Excellence provide opportunities to take forward these pan-Africa studies. More investments into molecular, epidemiological, clinical, diagnostic, and immunological studies across the African continent are required to enable further understanding of host-M. africanum interactions, leading to the development of more specific diagnostics, biomarkers, host-directed therapies, and vaccines for TB.

  6. Assessment and Evaluation of Quality of Life (OHRQoL) of Patients with Dental Implants Using the Oral Health Impact Profile (OHIP-14) - A Clinical Study

    PubMed Central

    2016-01-01

    Introduction 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. Aim To assess and evaluate Quality of Life (OHRQoL) of individuals with dental implants using the Oral Health Impact Profile (OHIP-14). Materials and Methods 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). Results 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). Conclusion 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. PMID:27190953

  7. Evaluation of Nontraditional Age Learners' Experiences in Internet-Based Clinical Social Work Courses

    ERIC Educational Resources Information Center

    Swanke, Jayme; Zeman, Laura Dreuth

    2015-01-01

    This study involves an evaluation of online learners' experiences with two Internet-based clinical social work courses. The evaluation sought to discover whether there were differences in learning between traditional (under 25 years old) and nontraditional age learners (25 years and over) who completed the asynchronous online course. The study…

  8. Clinical and Translational Scientist Career Success: Metrics for Evaluation

    PubMed Central

    Lee, Linda S.; Pusek, Susan N.; McCormack, Wayne T.; Helitzer, Deborah L.; Martina, Camille A.; Dozier, Ann; Ahluwalia, Jasjit S.; Schwartz, Lisa; McManus, Linda M.; Reynolds, Brian; Haynes, Erin; Rubio, Doris M.

    2012-01-01

    Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation. PMID:23067352

  9. [Travel diarrhea: attempt at a clinical-epidemiologic evaluation].

    PubMed

    Kollaritsch, H; Kremsner, P G; Tobisch, P; Ambrosch, F; Stemberger, H

    1987-06-30

    Traveller's diarrhea is the most common tourist's disease in the tropics. Therefore epidemiological data for the evaluation of factors influencing the attack rates and the severity of the disease are being required. This paper deals with the data of 1058 Austrian tourists travelling to warm climate countries. 47.3% of all travellers suffered from an episode of traveller's diarrhea during their stay. However, it could be evaluated that besides the destination seasonal influences were very important. Factors like individual hygiene and accommodation did not influence the attack rates. Age and environmental conditions, however, did partially influence the frequency of diarrhea. Furthermore, additional symptoms were interpreted and it could be seen that suspected heterogenicity of etiology leads to a similar pattern of clinical symptoms. Clinical evaluation proves that traveller's diarrhea is commonly not severe, but due to the incidence and duration of the disease it is a major health problem in modern tourism.

  10. Clinical and translational scientist career success: metrics for evaluation.

    PubMed

    Lee, Linda S; Pusek, Susan N; McCormack, Wayne T; Helitzer, Deborah L; Martina, Camille A; Dozier, Ann M; Ahluwalia, Jasjit S; Schwartz, Lisa S; McManus, Linda M; Reynolds, Brian D; Haynes, Erin N; Rubio, Doris M

    2012-10-01

    Despite the increased emphasis on formal training in clinical and translational research and the growth in the number and scope of training programs over the past decade, the impact of training on research productivity and career success has yet to be fully evaluated at the institutional level. In this article, the Education Evaluation Working Group of the Clinical and Translational Science Award Consortium introduces selected metrics and methods associated with the assessment of key factors that affect research career success. The goals in providing this information are to encourage more consistent data collection across training sites, to foster more rigorous and systematic exploration of factors associated with career success, and to help address previously identified difficulties in program evaluation.

  11. Developing an evaluation framework for clinical redesign programs: lessons learnt.

    PubMed

    Samaranayake, Premaratne; Dadich, Ann; Fitzgerald, Anneke; Zeitz, Kathryn

    2016-09-19

    Purpose The purpose of this paper is to present lessons learnt through the development of an evaluation framework for a clinical redesign programme - the aim of which was to improve the patient journey through improved discharge practices within an Australian public hospital. Design/methodology/approach The development of the evaluation framework involved three stages - namely, the analysis of secondary data relating to the discharge planning pathway; the analysis of primary data including field-notes and interview transcripts on hospital processes; and the triangulation of these data sets to devise the framework. The evaluation framework ensured that resource use, process management, patient satisfaction, and staff well-being and productivity were each connected with measures, targets, and the aim of clinical redesign programme. Findings The application of business process management and a balanced scorecard enabled a different way of framing the evaluation, ensuring measurable outcomes were connected to inputs and outputs. Lessons learnt include: first, the importance of mixed-methods research to devise the framework and evaluate the redesigned processes; second, the need for appropriate tools and resources to adequately capture change across the different domains of the redesign programme; and third, the value of developing and applying an evaluative framework progressively. Research limitations/implications The evaluation framework is limited by its retrospective application to a clinical process redesign programme. Originality/value This research supports benchmarking with national and international practices in relation to best practice healthcare redesign processes. Additionally, it provides a theoretical contribution on evaluating health services improvement and redesign initiatives.

  12. A placebo-controlled clinical evaluation of Kharjurapaka in Mamsakshaya

    PubMed Central

    Dhoke, Sujata P.; Dwivedi, Rambabu; Vyas, Mahesh

    2015-01-01

    Introduction: The world is facing most of the health problems due to nutritional imbalance, and Mamsakshaya (wasting) is one of them. Mamsakshaya explained in Kiyantahshirasiya Adhyaya can be considered as a separate entity, and it can be correlated with Karshya vyadhi. Mamsakshaya occurs due to diminished Prithvi and Jala Mahabhuta in the body and also due to improper diet and environmental factors. Kharjurapaka (KP) is having Prithvi and Jala Mahabhuta dominance and Guru (heavy), Shita (cold), Snigdha (unctuous) Guna (property) which are similar to conjugation of Mamsa Dhatu. Aim: The aim of this study is to evaluate Brimhana (nourishment) effect of KP on having signs and symptoms of Mamsakshaya patients. Materials and Methods: The study was therapeutic, interventional, randomized placebo controlled clinical trial carried out on 34 patients of Mamsakshaya. Patients were divided into two Groups. In Group A (trial group), KP (20 g) once in a day with normal water was administered for 30 days, and in Group B (control group), placebo tablet (500 mg) of roasted wheat flour for 30 days duration was administered. Effect of therapy was assessed on subjective and objective parameters, anthropometrical parameters such as body mass index (BMI), weight, and chest circumference. Results: It was found that Group A showed significant results in BMI and sign and symptom of Mamsakshaya in comparison to Group B. Conclusion: KP showed better efficacy in comparison with placebo group. PMID:27833368

  13. Evaluation of Neonatal Hemolytic Jaundice: Clinical and Laboratory Parameters

    PubMed Central

    Cherepnalkovski, Anet Papazovska; Krzelj, Vjekoslav; Zafirovska-Ivanovska, Beti; Gruev, Todor; Markic, Josko; Aluloska, Natasa; Zdraveska, Nikolina; Piperkovska, Katica

    2015-01-01

    BACKGROUND: Neonatal jaundice that occurs in ABO or Rhesus issoimunisation has been recognized as one of the major risk factors for development of severe hyperbilirubinemia and bilirubin neurotoxicity. AIM: Aim of our study was to investigate clinical and laboratory parameters associated with hemolytic jaundice due to Rh and ABO incompatibility and compare results with the group of unspecific jaundice. MATERIAL AND METHODS: One hundred sixty seven (167) neonatal hyperbilirubinemia cases were included in the study, 24.6% of which presented with ABO/Rhesus type hemolytic jaundice, and the rest with unspecific jaundice. Evaluation included: blood count, reticulocites, serum bilirubin, aminotransferases, blood grouping, and Coombs test, also the day of bilirubin peak, duration of the hyperbilirubinemia, and additional bilirubin measurements. RESULTS: We showed significantly lower mean values of hemoglobin, erythrocytes and hematocrit and significantly higher values of reticulocytes in the group of ABO/Rh incompatibility compared to the group of jaundice of unspecific etiology; also an earlier presentation and a higher-grade jaundice in this group. CONCLUSIONS: The laboratory profile in ABO/Rh isoimmunisation cases depicts hemolytic mechanism of jaundice. These cases carry a significant risk for early and severe hyperbilirubinemia and are eligible for neurodevelopmental follow-up. Hematological parameters and blood grouping are simple diagnostic methods that assist the etiological diagnosis of neonatal hyperbilirubinemia. PMID:27275310

  14. Evaluating the Risks of Clinical Research: Direct Comparative Analysis

    PubMed Central

    Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S.; Wendler, David

    2014-01-01

    Abstract Objectives: Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed “risks of daily life” standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. Methods: This study employed a conceptual and normative analysis, and use of an illustrative example. Results: Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the “risks of daily life” standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Conclusions: Direct comparative analysis is a systematic method for applying the “risks of daily life” standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about

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

    PubMed

    Chambers, Mark S; Fleming, Terence J; Toth, Béla B; Lemon, James C; Craven, Timothy E; Bouwsma, Otis J; Garden, Adam S; Espeland, Mark A; Keene, Harris J; Martin, Jack W; Sipos, Tibor

    2007-01-01

    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 (p<0.05). Patients in the control group had received

  16. [Changing surgical therapy because of clinical studies?].

    PubMed

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

    The randomised controlled clinical trial (RCT) is a powerful instrument to evaluate different therapeutic regimens. In a survey among 115 physicians visiting the 25th annual meeting of the Surgical Society of Berlin and Brandenburg, the RCT was judged to be very important when changes of therapeutic strategies are discussed. 90 % of all participants claimed to use data from RCTs in the clinical routine and 89 % would participate in such a trial. In official (e. g. discussions during coffee breaks at scientific meetings) or non-medical (e. g. non-scientific press or media) sources of information were assessed as irrelevant for decisions regarding therapeutic strategies. However, in contrast to this view laparoscopic cholecystectomy was introduced into clinical practice rapidly because patients informed by external (non-medical) sources preferred to be operated on with the "modern" technique. Clinical trials with a high level of evidence had no relevant influence on the rapid distribution of laparoscopic cholecystectomy. Controversial discussions concerning the extent of lymphadenectomy with gastric resection for carcinoma demonstrate that the value of excellent clinical RCTs is low if their results challenge a stable paradigma of the surgical scientific society. To allow a rational judgement, new surgical technologies should undergo a scientific gradual evaluation in agreement with the principles of evidence based medicine.

  17. Advances in clinical study of curcumin.

    PubMed

    Yang, Chunfen; Su, Xun; Liu, Anchang; Zhang, Lin; Yu, Aihua; Xi, Yanwei; Zhai, Guangxi

    2013-01-01

    Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies.

  18. Clinical methods in smoking cessation: description and evaluation of a stop smoking clinic.

    PubMed

    Harrup, T; Hansen, B A; Soghikian, K

    1979-12-01

    This study reports the results of the Kaiser-Permanente Stop Smoking Clinic and describes the philosophy and methods employed by the clinic in treating addictive smoking behavior. Of the 1,128 clients who registered for the group program, 57 per cent are abstinent six months after quitting smoking and 47 per cent are abstinent at one year. The clinic methods used are described in detail. They attempt to relate smoking behavior to the larger phenomenon of addiction.

  19. Clinical evaluation of efficacy of Majoon Ushba and Roghane Hindi in the management of psoriasis: A randomized single-blind, placebo-controlled study.

    PubMed

    Lone, Azad Hussain; Ahmad, Tanzeel; Naiyar, A H

    2011-01-01

    Psoriasis is a common dermatological disease affecting up to 1-2% of the world's population. It is associated with both organic and psychosocial complications like psoriatic arthropathy, nephritis, infection, hyperuricemia, hypoproteinemia, depression, and stress, and is responsible for hindering patients' daily activities. The present study was conducted to assess the safety and efficacy of two pharmacopeial Unani formulations (Majoon Ushba and Roghane Hindi) in the management of psoriasis on scientific parameters. Thirty diagnosed psoriasis patients, satisfying the inclusion criteria, were selected for a randomized, single-blind, placebo-controlled study in the Department of Moalajat (Medicine), National Institute of Unani Medicine, Bangalore. The patients were divided by the method of Random Table Numbers into test and control groups after obtaining informed consent. The experimental group comprised 20 patients to whom Majoon Ushba 5 g was administered orally twice daily and Roghane Hindi was applied locally twice daily. The control group comprised 10 patients who were given placebo drugs orally and topically. The duration of the trial was 8 weeks and follow-up was done fortnightly. The severity of psoriasis and efficacy of the drug was assessed by the Psoriasis Area and Severity Index (PASI) Scale. The results of both groups were compared and analyzed statistically. The study showed significant reduction in the PASI score in the test group (P < 0.01) as compared to placebo. No obnoxious side effects were observed in the test group: toxicological parameters were within normal limits even after 2 months of treatment. It was therefore concluded that Majoon Ushba and Roghane Hindi are safe and effective in the management of psoriasis.

  20. A clinical study to evaluate the efficacy of the antihistamine doxylamine succinate in the relief of runny nose and sneezing associated with upper respiratory tract infection.

    PubMed

    Eccles, R; Van Cauwenberge, P; Tetzloff, W; Borum, P

    1995-12-01

    Antihistamines are widely used in common cold medications, although the role of histamine in the development of common cold symptoms is unclear and the use of antihistamines for the treatment of common cold is controversial. It is clear that antihistamines do not offer a cure for common cold but they may alleviate symptoms of sneezing and runny nose. The present study was designed to investigate the efficacy of an antihistamine, doxylamine, on the symptoms of runny nose and sneezing associated with common cold. We conducted a randomized double-blind study in cold sufferers. One thousand and one volunteers with cold symptoms were screened in four centres (UK, Denmark, Belgium, Germany) and 688 satisfied the entry criteria of the study. The main reasons for excluding subjects were a low nasal secretion weight (secretion weight < 0.2g, 72%) and a low subjective rhinorrhoea score (24%). Volunteers were randomized to receive either doxylamine succinate 7.5 mg by mouth four times a day up to nine doses (n = 345) or placebo (n = 343). The principal measurements were prospectively defined as runny nose and sneezing symptom scores. Data were analysed on an intention-to-treat basis, using Cochran-Mantel-Haenszel statistics controlling for baseline symptom scores. A between-group comparison showed that doxylamine-treated volunteers benefited from a significantly greater reduction in runny nose scores (P < 0.01) and sneezing scores (P < 0.001), than those volunteers in the placebo group. Doxylamine therapy was well tolerated; the incidence of unexpected side-effects was comparable with placebo. Of the expected side-effects, 13.3% of doxylamine-treated patients reported drowsiness. The incidence of sedative effects was lower than has been reported for other commonly used first-generation antihistamines.

  1. A clinical study to evaluate the efficacy of intravitreal Anti-VEGF therapy in treating macular edema due to retinal venous occlusions

    PubMed Central

    Kumar, Poninder; Banarji, Ajay; Patyal, Sagarika; Gurunadh, V.S.; Ahluwalia, T.S.; Oli, Avadesh; Moulick, P.S.; Makker, Anuradha

    2013-01-01

    Background A non-randomized, interventional study was carried out various types of retinal venous occlusions with significant macular edema who required an Anti-VEGF injection. Method One hundred and one consecutive patients diagnosed as a case of CRVO/HCRVO/BRVO were enrolled in the study provided they had significant macular edema. Atleast three intra-vitreal injections of Anti-VEGFs were given and both the pre and post injections BCVA and CMT on OCT were observed and analyzed. Results 87 patients (86.14%) showed a significant improvement of vision of atleast two lines on the Snellen's and mean BCVA improved from log MAR +1.084 to log MAR +0.455. CMT on OCT showed reduction in thickness after Anti-VEGF therapy in 99 patients out of 101 and mean CMT decreased from 586.30 μ at baseline to 329.50 μ. Both of these findings were statistically very significant. Conclusions Anti-VEGF therapy had a marked improvement in BCVA along with a dramatic reduction in CMT in the vast majority of RVOs patients with no serious ocular or systemic side effects. PMID:24600120

  2. Comparative evaluation of healing after periodontal flap surgery using isoamyl 2-cyanoacrylate (bioadhesive material) and silk sutures: A split-mouth clinical study

    PubMed Central

    Khurana, Jyotsana Veneet; Mali, Amita Milind; Mali, Rohini Salil; Chaudhari, Amit Ulhas

    2016-01-01

    Background: Many factors contribute to uneventful and healthy postoperative healing. Hence, closure of periodontal flap postsurgery for the attainment of primary union between flap margins is of utmost importance. Isoamyl 2-cyanoacrylate is a tissue adhesive, which can be used for the closure of elevated flaps to overcome the problems associated with conventional suture material like silk. Aim: This study aims to compare healing after periodontal flap surgery using isoamyl 2-cyanoacrylate (bioadhesive material) and silk sutures. Materials and Methods: The study was carried out on twenty patients who needed flap surgical procedure for pocket therapy. Statistical Analysis Used: Results were subjected to statistical analysis. Paired t-test was used for intragroup postprocedure improvement in each parameter, and independent sample t-test was used for intergroup comparison. Results: Early healing was seen with isoamyl 2-cyanoacrylate during the 1st week when compared with silk. However, no significant difference was seen in the 2nd week when both the materials were compared. Conclusions: It can be concluded that cyanoacrylate aids in early initial healing. PMID:28298824

  3. Clinical Problem Solving Exercises for Pre-Clinical Medical Education: A Design, Implementation and Preliminary Evaluation.

    ERIC Educational Resources Information Center

    Bordage, Georges

    Clinical problem solving exercises for preclinical medical education that were developed at Michigan State University School of Osteopathic Medicine are described. Two types of outcomes were set as priorities in the design and implementation of the problem solving sessions: small group peer interactions as instructional and evaluative resources;…

  4. A randomised clinical study to evaluate the efficacy of alcohol-free or alcohol-containing mouthrinses with chlorhexidine on gingival bleeding

    PubMed Central

    Jose, A.; Butler, A.; Payne, D.; Maclure, R.; Rimmer, P.; Bosma, M. L.

    2015-01-01

    Objectives Gingival bleeding following twice-daily use of 0.2% w/v chlorhexidine digluconate mouthrinse with and without alcohol (0.2% CHX-alcohol; 0.2% CHX-alcohol-free, respectively) and brushing with a standard fluoride toothpaste was compared to brushing alone. Methods Three hundred and nineteen subjects with mild-to-moderate gingivitis (with ≥16 gradable permanent teeth including four molars, bleeding after brushing and ≥20 bleeding sites) completed this randomised, examiner-blinded, parallel-group study. A prophylaxis was performed at baseline. Gingival Severity Index (GSI; primary objective), Gingival Index (GI) and Plaque Index (PI) were assessed at baseline and after 6 weeks of treatment. Adverse events (AEs) were recorded throughout the study. Results Between treatment differences at week 6 demonstrated significantly lower GSI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (primary endpoint; treatment difference −0.061 [95% CI −0.081, −0.041] and −0.070 [95% CI −0.090, −0.050], respectively; both p <0.0001). There were also significant reductions in GI and PI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (all p <0.0001). The proportion of subjects reporting ≥1 treatment-related adverse events (TRAEs) was 27.8% (0.2% CHX-alcohol), 24.8% (0.2% CHX-alcohol-free) and 3.7% (brushing alone). Conclusions Chlorhexidine mouthrinse with or without alcohol as an adjunct to brushing with regular fluoride toothpaste significantly reduces bleeding scores, plaque and gingival inflammation compared to brushing alone. TRAEs are characteristic of those associated with the use of chlorhexidine and are similar for both mouthrinses. PMID:26271869

  5. An evaluation of motion compensation strategies and repeatability for abdominal (1)H MR spectroscopy measurements in volunteer studies and clinical trials.

    PubMed

    Germuska, M; Tunariu, N; Leach, M O; Xu, Jian; Payne, G S

    2012-06-01

    Increased expression of choline kinase has frequently been shown in tumours and is thought to be associated with disease progression. Studies using magnetic resonance spectroscopy have shown an increase in total choline-containing metabolites (tCho) in tumour compared with healthy tissue. Subsequent reductions in tCho following successful treatment support the use of tCho as a biomarker of disease and response. However, accurate measurement of tCho using MRS in abdominal tumours is complicated by respiratory motion, blurring the acquisition volume and degrading the lineshape and signal-to-noise ratio (SNR) of metabolites. Motion compensation using prospectively gated acquisitions or offline correction of phase and frequency distortions can help restore the SNR and linewidth of metabolites. Prospectively gated acquisitions have the advantage of confining the volume of acquisition to the prescribed volume but are constrained by the repetition time (TR) of the respiratory motion. In contrast, data acquired for offline correction may use a shorter repetition time and therefore yield an increased SNR per unit time. In this study abdominal spectra acquired from single-voxel 'free-breathing' measurements in liver of healthy volunteers and in abdominal tumours of cancer patients were compared with those of prospective gating and with an implementation of offline correction. The two motion compensation methodologies were assessed in terms of SNR, linewidth and repeatability. Our experiments show that prospective gating and offline correction result in a 12-22% reduction in median tCho linewidth, while offline correction also provides a significant increase in SNR. The repeatability coefficient (the expected interval for 95% of repeat measurements) for tCho/water ratio was reduced by 37% (prospective gating) and 41% (offline correction). Both methods of motion compensation substantially improved the reproducibility of the tCho/water measurement and the tCho linewidth. While

  6. Clinical study on evaluation of anti-cataract effect of Triphaladi Ghana Vati and Elaneer Kuzhambu Anjana in Timira (immature cataract)

    PubMed Central

    Bhati, Hitesh; Manjusha, R.

    2015-01-01

    Introduction: Senile cataract is the leading cause of blindness according to the World Health Report, 1998. Till date no accepted medical treatment is available for cataract. In Ayurveda visual disturbances are described in the context of Timira, Kacha and Linganasha. Timira is an early stage characterized by blurring of vision and Linganasha is end stage where complete loss of vision occurs. Ancient scholars have advocated different Anjana application and oral medications in the Timira and Kacha stage. Aim: To study the efficacy of test drugs Triphaladi Ghana Vati and Elaneer Kuzhambu Anjana in immature cataract. Materials and Methods: In this trial patients having Senile Immature Cataract were randomized with equal probability to one of the two treatment Groups A and B (n = 20 each). In Group A Triphaladi Ghana Vati 500 mg internally for 3 months and in Group B Triphaladi Ghana Vati 500 mg internally and Elaneer Kuzhambu Anjana for local application were given. Assessment was done on the basis of blurring of vision, visualization of nonexisting things, difficulty in bright light and dim light or night vision, distant visual acuity, pinhole vision, best corrected visual acuity and cataract grading on slit lamp. Results: Both groups showed statistically significant changes in blurring of vision, difficulty in glare, daytime and bright light, distant visual activity, pinhole vision, and best-corrected visual acuity. Group B also showed significant changes in difficulty in night time, visualization of nonexisting things and in nuclear cataract. Conclusion: The study establishes that test drugs can reduce and control the progress of immature cataract, and combined therapy was found more effective. Chakshushya Rasayana, early diagnosis and proper management on Doshic lines can prevent arrest or delay senile cataract. PMID:27313415

  7. Evaluation of the prophylactic use of mitomycin-C to inhibit haze formation after photorefractive keratectomy in high myopia: a prospective clinical study

    PubMed Central

    Hashemi, Hassan; Taheri, Seied Mohammad Reza; Fotouhi, Akbar; Kheiltash, Azita

    2004-01-01

    Background To study the effect of prophylactic application of mitomycin-C on haze formation in photorefractive keratectomy (PRK) for high myopia. Methods Fifty-four eyes of 28 myopic patients were enrolled in this prospective study. All eyes were operated by PRK followed by 0.02% mitomycin-C application for two minutes and washed with 20 ml normal saline afterwards. All eyes were examined thoroughly on the first 7 days and one month after surgery; 48 eyes (88.9%) at 3 and 6 months postoperatively. Hanna grading (in the scale of 0 to 4+) was used for assessment of corneal haze. Results The mean spherical equivalent refraction (SE) was -7.08 diopters (D) ± 1.11 (SD) preoperatively. Six months after surgery, 37 eyes (77.1%) achieved an uncorrected visual acuity (UCVA) of 20/20 or better, all eyes had a UCVA of 20/40 or better and 45 (93.7%) eyes had an SE within ± 1.00D. One month postoperatively, 2 eyes (3.7%) had grade 0.5+ of haze, while at 3 and 6 months after surgery no visited eye had haze at all. All eyes had a best corrected visual acuity (BCVA) of 20/40 or better and there were no lost lines in BCVA by 6 months after surgery. In spatial frequencies of 6 and 12 cycles per degree contrast sensitivity had decreased immediately after PRK and it had increased 1.5 lines by the 6th postoperative month compared to the preoperative data. Conclusions The results show the efficacy of mitomycin-C in preventing corneal haze after treatment of high myopia with PRK. This method- PRK + mitomycin-C – can be considered an alternative treatment for myopic patients whose corneal thicknesses are inadequate for laser in situ keratomileusis (LASIK). However, the results should be confirmed in longer follow-ups. PMID:15363107

  8. Clinical evaluation of the failure rates of metallic brackets

    PubMed Central

    ROMANO, Fábio Lourenço; CORRER, Américo Bortolazzo; CORRER-SOBRINHO, Lourenço; MAGNANI, Maria Beatriz Borges de Araújo; RUELLAS, Antônio Carlos de Oliveira

    2012-01-01

    Objectives The aim of this study was to evaluate in vivo the bonding of metallic orthodontic brackets with different adhesive systems. Material and Methods Twenty patients (10.5-15.1 years old) who had sought corrective orthodontic treatment at a University Orthodontic Clinic were evaluated. Brackets were bonded from the right second premolar to the left second premolar in the upper and lower arches using: Orthodontic Concise, conventional Transbond XT, Transbond XT without primer, and Transbond XT associated with Transbond Plus Self-etching Primer (TPSEP). The 4 adhesive systems were used in all patients using a split-mouth design; each adhesive system was used in one quadrant of each dental arch, so that each group of 5 patients received the same bonding sequence. Initial archwires were inserted 1 week after bracket bonding. The number of bracket failures for each adhesive system was quantified over a 6-month period. Results The number of debonded brackets was: 8- Orthodontic Concise, 2- conventional Transbond XT, 9- Transbond XT without primer, and 1- Transbond XT + TPSEP. By using the Kaplan-Meier methods, statistically significant differences were found between the materials (p=0.0198), and the Logrank test identified these differences. Conventional Transbond XT and Transbond XT + TPSEP adhesive systems were statistically superior to Orthodontic Concise and Transbond XT without primer (p<0.05). There was no statistically significant difference between the dental arches (upper and lower), between the dental arch sides (right and left), and among the quadrants. Conclusions The largest number of bracket failures occurred with Orthodontic Concise and Transbond XT without primer systems and few bracket failures occurred with conventional Transbond XT and Transbond XT+TPSEP. More bracket failures were observed in the posterior region compared with the anterior region. PMID:22666842

  9. Frequentist evaluation of group sequential clinical trial designs.

    PubMed

    Emerson, Scott S; Kittelson, John M; Gillen, Daniel L

    2007-12-10

    Group sequential stopping rules are often used as guidelines in the monitoring of clinical trials in order to address the ethical and efficiency issues inherent in human testing of a new treatment or preventive agent for disease. Such stopping rules have been proposed based on a variety of different criteria, both scientific (e.g. estimates of treatment effect) and statistical (e.g. frequentist type I error, Bayesian posterior probabilities, stochastic curtailment). It is easily shown, however, that a stopping rule based on one of these criteria induces a stopping rule on all other criteria. Thus, the basis used to initially define a stopping rule is relatively unimportant so long as the operating characteristics of the stopping rule are fully investigated. In this paper we describe how the frequentist operating characteristics of a particular stopping rule might be evaluated to ensure that the selected clinical trial design satisfies the constraints imposed by the many different disciplines represented by the clinical trial collaborators.

  10. Comparative evaluation of a dentifrice containing calcium sodium phosphosilicate to a dentifrice containing potassium nitrate for dentinal hypersensitivity: A clinical study

    PubMed Central

    Satyapal, Tanya; Mali, Rohini; Mali, Amita; Patil, Vishakha

    2014-01-01

    Background: Calcium sodium phosphosilicate is a recently introduced desensitizing agent which acts by occluding the dentinal tubules and also resists acid decalcification. This study was designed to assess the efficacy of a new toothpaste containing 5% calcium sodium phosphosilicate for the treatment of dentinal hypersensitivity and also compare it with 5% potassium nitrate. Materials and Methods: Sixty patients with the chief complaint of dentinal hypersensitivity were enrolled and randomly divided into two groups. The visual analog scale (VAS) scores were taken for water and air stimuli at baseline, 3 weeks after usage of the respective toothpaste, and 3 weeks after discontinuation of the respective toothpaste. Results: Both the groups showed reduction in hypersensitivity scores at 3 weeks and 6 weeks for air stimulus and cold water. The calcium sodium phosphosilicate group, however, showed significantly reduction in hypersensitivity compared to the potassium nitrate group at any time point for both measures of hypersensitivity. Conclusion: The 5% calcium sodium phosphosilicate group showed immense reduction in dentinal hypersensitivity symptoms. The 5% calcium sodium phosphosilicate showed prolonged effects even after discontinuation as compared to 5% potassium nitrate, due to its dentinal tubular occlusion property. PMID:25425819

  11. European multicentre evaluation of the ABBOTT Spectrum clinical chemistry analyzer.

    PubMed

    Blijenberg, B G; Braconnier, F; Vallez, J M; Burlina, A; Plebani, M; Celadin, M; Haeckel, R; Römer, M; Hänseler, E; De Schrijver, G

    1989-06-01

    The analytical performance of the selective multitest ABBOTT Spectrum analyser was studied according to the ECCLS guidelines and partly the CERMAB protocol in a multicentre evaluation involving laboratories from six European countries. Fifteen analytes, including the electrolytes sodium, potassium and chloride, were measured each in at least 3 laboratories, all at 37 degrees C, except the electrolytes, which are measured at room temperature. The trial lasted approximately three months and involved the collection of over 60,000 data points. It yielded the following results: 1. The precision was at least as good as the precision obtained with the comparison instruments. The majority of the coefficients of variation were between 1 and 4%. 2. The recovery for method assigned control sera values was, with few exceptions, within 10%. 3. Good agreement with respect to the method assigned values of control materials and method comparison with patient specimens to different instruments (e.g. SMAC, Hitachi 737, RA 1000) was found. 4. No drift was observed. 5. Reagent-related carry-over was not found. Specimen-related carry-over was detected in some cases, the deviation being of little or no clinical significance. 6. The manufacturer's claims regarding method linearity were as stated or exceeded. 7. The open system capability was tested and rated as very convenient. 8. The practicability of the instrument was very good.

  12. Clinical evaluations of mineralized collagen in the extraction sites preservation

    PubMed Central

    Feng, Lu; Zhang, Liang; Cui, Yun; Song, Tian-Xi; Qiu, Zhi-Ye; Wang, Xiu-Mei; Tan, Bao-Sheng

    2016-01-01

    The purpose of this study was to explore the different effects between biomimetic mineralized collagen (MC) and ordinary physically blended hydroxyapatite/collagen (HA/Col) composite in evaluating new bone formation and regenerated bone height in human extraction sockets. Thirty-four patients who cannot retain teeth caused by trauma or decay were randomly selected from Department of Stomatology of Dongzhimen Hospital from December 2013 to December 2014. The patients were randomly divided into two groups. After the operation of tooth extraction, 17 patients were implanted with biomimetic MC (MC group), and other 17 patients were implanted with ordinary physically blended nHA/Col composite (nHA/Col group). X-ray positioning projection by auto-photographing was taken to test the distance between the lowest position and the neighboring CEJm-CEJd immediately, 1 month and 3 months after the operation. The height of new bone formation of the MC group was significantly higher than the nHA/Col group. Biomimetic MC showed better clinical outcomes in the bone formation for extraction site preservation and would have broad application prospect in the field of oral and maxillofacial surgeries. PMID:26815224

  13. Clinical skills evaluation of trainees in a neurology department.

    PubMed

    Wiles, C M; Dawson, K; Hughes, T A T; Llewelyn, J G; Morris, H R; Pickersgill, T P; Robertson, N P; Smith, P E M

    2007-08-01

    Three to 12 evaluations of clinical performance using the mini-clinical evaluation exercise (Mini-CEX) (n = 124) or direct observation of procedural skills (DOPS) (n = 21) were performed on 27 trainees working in an NHS neurology department. The communications/ counselling skills subdomain was scored in 64 evaluations. For Mini-CEX the focus was on gathering data (22%), diagnosis (31%), management (34%) and counselling (7%) (focus not recorded in 6%). For DOPS, lumbar puncture was the most common evaluated procedure (57%). Mini-CEX evaluations lasted 23.8 minutes (10.6) (mean, sd) and DOPS 25.9 minutes (12.6). Mini-CEX scores for overall competence and communication skills were mean 5.99 (sd 0.95, range 4-8) and 5.98 (sd 1.21, range 3-9) and for DOPS 5.71 (sd 0.90, range 4-8) both on scales of 1 to 9. Overall trainee competence and communication scores increased with year of training (p < 0.001, p < 0.004 univariate analysis). Assessors undertook up to three or four assessments in a session. Assessors and trainees considered that the observation and feedback had been 'very' or 'quite' useful in providing a relevant element of assessment. These assessments were feasible and useful in a neurology department and provided some evidence for increasing performance with trainee seniority. More assessor time (approximately one hour) than trainee time (24-26 min) was needed for each assessment undertaken.

  14. Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

    PubMed Central

    Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

    2017-01-01

    Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

  15. Clinical evaluator reliability for quantitative and manual muscle testing measures of strength in children.

    PubMed

    Escolar, D M; Henricson, E K; Mayhew, J; Florence, J; Leshner, R; Patel, K M; Clemens, P R

    2001-06-01

    Measurements of muscle strength in clinical trials of Duchenne muscular dystrophy have relied heavily on manual muscle testing (MMT). The high level of intra- and interrater variability of MMT compromises clinical study results. We compared the reliability of 12 clinical evaluators in performing MMT and quantitative muscle testing (QMT) on 12 children with muscular dystrophy. QMT was reliable, with an interclass correlation coefficient (ICC) of >0.9 for biceps and grip strength, and >0.8 for quadriceps strength. Training of both subjects and evaluators was easily accomplished. MMT was not as reliable, and required repeated training of evaluators to bring all groups to an ICC >0.75 for shoulder abduction, elbow and hip flexion, knee extension, and ankle dorsiflexion. We conclude that QMT shows greater reliability and is easier to implement than MMT. Consequently, QMT will be a superior measure of strength for use in pediatric, neuromuscular, multicenter clinical trials.

  16. Clinical evaluation of a new biofeedback standing balance training device.

    PubMed

    Lee, M Y; Wong, M K; Tang, F T

    1996-01-01

    For patients with neurological damage of the central nervous system, such as that due to cerebrovascular accident (CVA), standing balance training is a critical therapeutic procedure to be undertaken before walking and self-care training. The identification and characterization of neurological disorder in postural steadiness will enhance our understanding of the postural control system, and help to identify patients at risk of falls in the CVA population. This paper discusses the design and clinical evaluation of a new biofeedback training device for static (postural steadiness) performance of the standing balance system. The device includes a height adjustable standing table, an instrumented force sensing platform, an on-line weight bearing audio/visual biofeedback system, a postural correction mirror, and a belt suspension system for the upper extremities. A quantitative evaluation protocol of bilateral asymmetries in weight distribution and postural sway to characterize standing balance with the force sensing platform is discussed. Finally, the clinical evaluation results of sixty patients with hemiplegia from acute stroke for a period of four weeks are discussed. With this economic standing training device, the static standing steadiness can be trained effectively through weight bearing biofeedback and a postural correction mirror in the clinical and home caring environments.

  17. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    PubMed

    Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

    2015-06-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented.

  18. Industrial laser welding evaluation study

    NASA Technical Reports Server (NTRS)

    Hella, R.; Locke, E.; Ream, S.

    1974-01-01

    High power laser welding was evaluated for fabricating space vehicle boosters. This evaluation was made for 1/4 in. and 1/2 in. aluminum (2219) and 1/4 in. and 1/2 in. D6AC steel. The Avco HPL 10 kW industrial laser was used to perform the evaluation. The objective has been achieved through the completion of the following technical tasks: (1) parameter study to optimize welding and material parameters; (2) preparation of welded panels for MSFC evaluation; and (3) demonstration of the repeatability of laser welding equipment. In addition, the design concept for a laser welding system capable of welding large space vehicle boosters has been developed.

  19. Clinical Evaluation of Efficacy of CIA and CNA Intrusion Arches

    PubMed Central

    Vora, Sambhav; Pandey, Vinisha

    2015-01-01

    Background and Objectives Excessive overbite is one of the most common problems that confront the orthodontist. Deep bite can be due to infraocclusion of posterior teeth, supraocclusion of anterior teeth or a combination of the two. Correction of same can be carried out by extrusion of molars, intrusion of incisors or by a combination of both respectively. Various intrusion arches are recommended for correcting deep bite by true intrusion of anterior teeth, Utility arches, Segmental arch, Connecticut Intrusion Arch (CIA) and Connecticut New Arch (CNA). The purpose of this study was to evaluate clinical efficacy of CIA and CNA intrusion arches. Materials and Methods Tracings recorded from pre and post-treatment lateral cephalograms of 25 patients treated by CIA (Group I) and another 25 patients treated by CNA (Group II) intrusion arches in deep bite cases after four months of treatment were analysed and findings were recorded. Statistical Analysis Paired t-test was used to compare pre and post-treatment changes within Groups I and II and unpaired t-test was used to compare treatment changes between Group I and Group II. A P-value of < 0.05 was set for statistical significance. Results Findings of this study demonstrate that an average of 1mm of intrusion takes place with CIA intrusion arch and 1.3mm with CNA intrusion arch in a period of 4 months. Both intrusion arches do not affect the position of molar in vertical or anteroposterior plane. Interpretation & Conclusion Both CIA and CNA intrusion arches are effective in bringing about intrusion of lower incisors. PMID:26501008

  20. Clinical, molecular, and genetic evaluation of galactosemia in Turkish children

    PubMed Central

    Atik, Sezen Ugan; Gürsoy, Semra; Koçkar, Tuba; Önal, Hasan; Adal, Servet Erdal

    2016-01-01

    Aim Galactosemia is a carbohydrate metabolism disorder with autosomal recessive inheritance. The most frequent enzyme deficiency is galactose-1-phosphate-uridylytransferase, which causes classic galactosemia. When the enzyme is absent, an infant cannot metabolize galactose-1-phosphate and it cumulates in liver, kidney, brain, tongue, lens, and skin. This study aimed to evaluate the clinical and molecular characteristics of patients with galactosemia, which is observed more frequently in our country than anywhere else in the world. Material and Methods This is a retrospective study that includes the moleculer and genetic charcteristics of 14 patient who were diagnosed as having galactosemia between January 2009 and January 2011. Results Nine patients were male and 5 female. Consanguineous marriage was detected in the family history of 7 patients. One patient had a history of a deceased sibling with a confirmed diagnosis of galactosemia. The main reasons for admission to the hospital were jaundice in 9, hypoglycemia in 2, sepsis in 2, and elevated liver enzymes in 1 patient. The Beutler test was positive in all patients. The mean enzyme activity was 0.36±0.26 μmol/mL. Only 6 of our cases were diagnosed in the early period (first 15 days). Cataract was present in four patients. Q188R mutation was observed in 13 patients, and homozygote N314D and homozygote E340X mutations were observed in one patient. Three patients had impaired neurologic development according to the Denver Developmental Screening Test II. Conclusion The most common genetic abnormality was Q188R mutation. Only 43% of our patients’s disease could be diagnosed at an early stage. We suggest that galactosemia should be included in the national newborn screening program in order to make earlier diagnoses. PMID:28123333

  1. A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

    ERIC Educational Resources Information Center

    Lee, Seon Ah

    2010-01-01

    The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

  2. PPB | What is a Clinical Study

    Cancer.gov

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  3. [Thought on several problems of post-marketing herbs clinical evaluation in special populations].

    PubMed

    Zhou, Ai; Lian, Fengmei

    2011-10-01

    The re-evaluation of clinical post-marketing herbs in special populations, such as children, the aged, pregnant women, lactating women, has attracted attention in our country. The media is drug adverse reaction reports and package insert. The safety of combined administration in aged and children's growth should have been taken long-term follow-up study. Perfecting traditional chinese medicine FDA system will be beneficial to the re-evaluation of clinical postmarketing herbs in pregnant women. Dose-effect study in children also should cause the concern of researchers.

  4. Three-year randomised clinical trial to evaluate the clinical performance, quantitative and qualitative wear patterns of hybrid composite restorations.

    PubMed

    Palaniappan, Senthamaraiselvi; Elsen, Liesbeth; Lijnen, Inge; Peumans, Marleen; Van Meerbeek, Bart; Lambrechts, Paul

    2010-08-01

    The aim of the study was to compare the clinical performance, quantitative and qualitative wear patterns of conventional hybrid (Tetric Ceram), micro-filled hybrid (Gradia Direct Posterior) and nano-hybrid (Tetric EvoCeram, TEC) posterior composite restorations in a 3-year randomised clinical trial. Sixteen Tetric Ceram, 17 TEC and 16 Gradia Direct Posterior restorations were placed in human molars and evaluated at baseline, 6, 12, 24 and 36 months of clinical service according to US Public Health Service criteria. The gypsum replicas at each recall were used for 3D laser scanning to quantify wear, and the epoxy resin replicas were observed under scanning electron microscope to study the qualitative wear patterns. After 3 years of clinical service, the three hybrid restorative materials performed clinically well in posterior cavities. Within the observation period, the nano-hybrid and micro-hybrid restorations evolved better in polishability with improved surface gloss retention than the conventional hybrid counterpart. The three hybrid composites showed enamel-like vertical wear and cavity-size dependant volume loss magnitude. Qualitatively, while the micro-filled and nano-hybrid composite restorations exhibited signs of fatigue similar to the conventional hybrid composite restorations at heavy occlusal contact area, their light occlusal contact areas showed less surface pitting after 3 years of clinical service.

  5. Three-year randomised clinical trial to evaluate the clinical performance, quantitative and qualitative wear patterns of hybrid composite restorations

    PubMed Central

    Palaniappan, Senthamaraiselvi; Elsen, Liesbeth; Lijnen, Inge; Peumans, Marleen; Van Meerbeek, Bart

    2009-01-01

    The aim of the study was to compare the clinical performance, quantitative and qualitative wear patterns of conventional hybrid (Tetric Ceram), micro-filled hybrid (Gradia Direct Posterior) and nano-hybrid (Tetric EvoCeram, TEC) posterior composite restorations in a 3-year randomised clinical trial. Sixteen Tetric Ceram, 17 TEC and 16 Gradia Direct Posterior restorations were placed in human molars and evaluated at baseline, 6, 12, 24 and 36 months of clinical service according to US Public Health Service criteria. The gypsum replicas at each recall were used for 3D laser scanning to quantify wear, and the epoxy resin replicas were observed under scanning electron microscope to study the qualitative wear patterns. After 3 years of clinical service, the three hybrid restorative materials performed clinically well in posterior cavities. Within the observation period, the nano-hybrid and micro-hybrid restorations evolved better in polishability with improved surface gloss retention than the conventional hybrid counterpart. The three hybrid composites showed enamel-like vertical wear and cavity-size dependant volume loss magnitude. Qualitatively, while the micro-filled and nano-hybrid composite restorations exhibited signs of fatigue similar to the conventional hybrid composite restorations at heavy occlusal contact area, their light occlusal contact areas showed less surface pitting after 3 years of clinical service. PMID:19669176

  6. Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

    PubMed Central

    McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

    2014-01-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

  7. Agreement between Therapists, Parents, Patients, and Independent Evaluators on Clinical Improvement in Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Lewin, Adam B.; Peris, Tara S.; De Nadai, Alessandro S.; McCracken, James T.; Piacentini, John

    2012-01-01

    Objective: Independent evaluators (IE) are used widely in clinical trials to make unbiased determinations of treatment response. By virtue of being kept blind to treatment condition, however, IEs are also kept unaware of many pertinent clinical details that are relevant for decisions about clinical improvement. In this study, agreement among…

  8. A comparative evaluation of freeze-dried bone allograft with and without bioabsorbable guided tissue regeneration membrane Healiguide® in the treatment of Grade II furcation defects: A clinical study

    PubMed Central

    Jain, Deept; Deepa, Dhruvakumar

    2015-01-01

    Background: Furcation defects represent one of the most demanding therapeutic challenges for periodontal therapy. Various treatment modalities have been tried with different success rates. The present study was undertaken to evaluate the efficacy of freeze-dried bone allograft (FDBA) with and without bioabsorbable guided tissue regeneration (GTR) membrane Healiguide® in the treatment of Grade II furcation defects. Materials and Methods: Ten patients with bilateral Grade II furcation defects were selected for the study. After phase I therapy, subjects were divided into two arms and treated in a split-mouth design. Ten defects were treated with FDBA alone in the control arm. Ten defects were treated with FDBA in conjunction with bioabsorbable GTR membrane Healiguide® in test arm. Clinical parameters like plaque index, gingival index, vertical probing depth, horizontal probing depth, and relative attachment level (RAL) were assessed at baseline, 3 months, and 6 months postoperatively. Results: At 6 months, clinical improvement was seen in both the arms with mean pocket depth reduction of 1.2 ± 1.032 mm and 1.7 ± 0.948 mm and mean horizontal probing depth reduction being 2.1 ± 1.969 mm and 1.6 ± 1.264 mm in control and test arm, respectively. Both surgical procedures resulted in a statistically significant reduction in vertical and horizontal probing depths. Conclusion: Both the arms demonstrated a significant improvement in the probing depth, horizontal furcation depth, and RAL at 6 months postsurgery in the treatment of Grade II furcation defects. However, on the intergroup comparison, there was no statistically significant difference in the results achieved between two arms. PMID:26941515

  9. A prospective two-center study on the associations between microalbuminuria, coronary atherosclerosis and long-term clinical outcome in asymptomatic patients with type 2 diabetes mellitus: evaluation by coronary CT angiography.

    PubMed

    Kim, Jin-Jin; Hwang, Byung-Hee; Choi, Ik Jun; Choo, Eun-Ho; Lim, Sungmin; Koh, Yoon-Seok; Lee, Jong Min; Kim, Pum-Joon; Seung, Ki-Bae; Lee, Seung-Hwan; Cho, Jae-Hyung; Jung, Jung Im; Chang, Kiyuk

    2015-01-01

    This study assessed the associations between microalbuminuria in asymptomatic patients with type 2 diabetes and the presence, extent, and severity of coronary atherosclerosis, as measured by coronary computed tomography angiography (CCTA), and the long-term clinical outcomes. In total, the study enrolled 284 consecutive eligible asymptomatic patients with type 2 diabetes and without known coronary artery disease (CAD), who then underwent CCTA and 24 h urine albumin measurements. Microalbuminuria was defined as 30-300 mg/day urinary albumin excretion. Obstructive CAD, as measured by CCTA, was defined as maximum intra-luminal stenosis ≥50 %. Patients with and without microalbuminuria were compared in terms of obstructive CAD prevalence, and the extent and severity of coronary atherosclerosis. They were evaluated using the following data: coronary artery calcium score (CACS), atheroma burden obstructive score (ABOS), segment involvement score (SIS) and segment stenosis score (SSS). All-cause mortality within a follow-up period of 5 years was also compared. Compared to patients without microalbuminuria, patients with microalbuminuria were more likely to have obstructive CAD (p = 0.004). Microalbuminuria was associated with higher ABOS (p = 0.010), SIS (p = 0.029), and SSS (p = 0.011), except for CACS (p = 0.058). Multivariable analyses adjusted for conventional cardiovascular risk factors revealed that microalbuminuria was an independent predictor of obstructive CAD [odds ratio 2.255, confidence intervals (CI) 1.121-4.538, p = 0.023] and all-cause mortality (hazard ratio 3.469, CI 1.319-9.121, p = 0.012). In asymptomatic patients with type 2 diabetes, microalbuminuria was associated with increased risk of CAD and poorer clinical outcomes.

  10. [Comparative evaluation of clinical effectiveness of treatment of giardiasis].

    PubMed

    2014-09-01

    Giardia is the most common causes of protozoan diarrhea that leads to significant morbidity and mortality worldwide. The purpose of this study was to determine the clinical efficiency of different scheme of therapy giardiasis with new original plant preparation "Sausalin" (Kazakhstan). We conducted open clinical trial with participation of 93 patients with giardiasis. According the method of treatment the patients were divided into three groups.  Group I - Sausalin at the dose 300 mg/day; group II - Metronidazole at 750 mg/ day; group III - combination of Sausalin 300 mg/day and Metronidazole 750 mg/ day. The treatment was conducted during 10 days. The protozoal clearance rate and clinical symptoms were assessed. There were no significant differences in the efficiency of treatments in group I and group II. The protozoal clearance rate was 68% in group I (Sausalin); in group II -  42,1% (metronidazole). In group III - 83,2% (combination therapy) (р=0.001; 95% CI 54,6-89,7). There was no negative effect on clinical and biochemical blood analysis. We detected statistically significant differences in the dynamics of clinical symptoms (defecation disorders, dyspepsia, abdominal pain, asthenia) of giardiasis in a group of patients receiving Sausalin.The scheme with new drug Sausalin can be used as alternative treatment of Giardiasis. Moreover, the use of the Sausalin is improved the clinical symptoms and safety of therapy.

  11. Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

    PubMed Central

    Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

    2015-01-01

    Background Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. Purpose To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Material and Methods Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. Results KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. Conclusion The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites. PMID:26668754

  12. Design and evaluation of a bacterial clinical infectious diseases ontology.

    PubMed

    Gordon, Claire L; Pouch, Stephanie; Cowell, Lindsay G; Boland, Mary Regina; Platt, Heather L; Goldfain, Albert; Weng, Chunhua

    2013-01-01

    With antimicrobial resistance increasing worldwide, there is a great need to use automated antimicrobial decision support systems (ADSSs) to lower antimicrobial resistance rates by promoting appropriate antimicrobial use. However, they are infrequently used mostly because of their poor interoperability with different health information technologies. Ontologies can augment portable ADSSs by providing an explicit knowledge representation for biomedical entities and their relationships, helping to standardize and integrate heterogeneous data resources. We developed a bacterial clinical infectious diseases ontology (BCIDO) using Protégé-OWL. BCIDO defines a controlled terminology for clinical infectious diseases along with domain knowledge commonly used in hospital settings for clinical infectious disease treatment decision-making. BCIDO has 599 classes and 2355 object properties. Terms were imported from or mapped to Systematized Nomenclature of Medicine, Unified Medical Language System, RxNorm and National Center for Bitechnology Information Organismal Classification where possible. Domain expert evaluation using the "laddering" technique, ontology visualization, and clinical notes and scenarios, confirmed the correctness and potential usefulness of BCIDO.

  13. Urokinase immobilized on medical polymeric materials: fundamental and clinical studies.

    PubMed

    Ohshiro, T; Kosaki, G

    1980-02-01

    One of the methods of preparing an antithrombogenic material is to immobilize a fibrinolytic enzyme on the surface of a carrier. The clinical trial of such a material must be subject to not only a basic study on the quality of a carrier, the technique of immobilization, and the method of disinfection, but also an in vivo study on its antithrombotic effect. Reported herein is the evaluation of the fibrinolytic ability, at fundamental and clinical levels, of the urokinase that was immobilized on the surface of various polymeric materials. The results were favorable.

  14. Criteria for clinical translucency evaluation of direct esthetic restorative materials

    PubMed Central

    2016-01-01

    The purpose of this review was to suggest practical criteria for the clinical translucency evaluation of direct esthetic restorative materials, and to review the translucency with these criteria. For the evaluation of reported translucency values, measuring instrument and method, specimen thickness, background color, and illumination should be scrutinized. Translucency parameter (TP) of 15 to 19 could be regarded as the translucency of 1 mm thick human enamel. Visual perceptibility threshold for translucency difference in contrast ratio (ΔCR) of 0.07 could be transformed into ΔTP value of 2. Translucency differences between direct and indirect resin composites were perceivable (ΔTP > 2). Universal and corresponding flowable resin composites did not show perceivable translucency differences in most products. Translucency differed significantly by the product within each shade group, and by the shade group within each product. Translucency of human enamel and perceptibility threshold for translucency difference may be used as criteria for the clinical evaluation of translucency of esthetic restorative materials. PMID:27508156

  15. Criteria for clinical translucency evaluation of direct esthetic restorative materials.

    PubMed

    Lee, Yong-Keun

    2016-08-01

    The purpose of this review was to suggest practical criteria for the clinical translucency evaluation of direct esthetic restorative materials, and to review the translucency with these criteria. For the evaluation of reported translucency values, measuring instrument and method, specimen thickness, background color, and illumination should be scrutinized. Translucency parameter (TP) of 15 to 19 could be regarded as the translucency of 1 mm thick human enamel. Visual perceptibility threshold for translucency difference in contrast ratio (ΔCR) of 0.07 could be transformed into ΔTP value of 2. Translucency differences between direct and indirect resin composites were perceivable (ΔTP > 2). Universal and corresponding flowable resin composites did not show perceivable translucency differences in most products. Translucency differed significantly by the product within each shade group, and by the shade group within each product. Translucency of human enamel and perceptibility threshold for translucency difference may be used as criteria for the clinical evaluation of translucency of esthetic restorative materials.

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

    PubMed

    Ogawa, Hisao; Kojima, Sunao

    2009-10-01

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

  17. Neural basis of nonanalytical reasoning expertise during clinical evaluation

    PubMed Central

    Durning, Steven J; Costanzo, Michelle E; Artino, Anthony R; Graner, John; van der Vleuten, Cees; Beckman, Thomas J; Wittich, Christopher M; Roy, Michael J; Holmboe, Eric S; Schuwirth, Lambert

    2015-01-01

    Introduction Understanding clinical reasoning is essential for patient care and medical education. Dual-processing theory suggests that nonanalytic reasoning is an essential aspect of expertise; however, assessing nonanalytic reasoning is challenging because it is believed to occur on the subconscious level. This assumption makes concurrent verbal protocols less reliable assessment tools. Methods Functional magnetic resonance imaging was used to explore the neural basis of nonanalytic reasoning in internal medicine interns (novices) and board-certified staff internists (experts) while completing United States Medical Licensing Examination and American Board of Internal Medicine multiple-choice questions. Results The results demonstrated that novices and experts share a common neural network in addition to nonoverlapping neural resources. However, experts manifested greater neural processing efficiency in regions such as the prefrontal cortex during nonanalytical reasoning. Conclusions These findings reveal a multinetwork system that supports the dual-process mode of expert clinical reasoning during medical evaluation. PMID:25798328

  18. Performance evaluation and clinical applications of 3D plenoptic cameras

    NASA Astrophysics Data System (ADS)

    Decker, Ryan; Shademan, Azad; Opfermann, Justin; Leonard, Simon; Kim, Peter C. W.; Krieger, Axel

    2015-06-01

    The observation and 3D quantification of arbitrary scenes using optical imaging systems is challenging, but increasingly necessary in many fields. This paper provides a technical basis for the application of plenoptic cameras in medical and medical robotics applications, and rigorously evaluates camera integration and performance in the clinical setting. It discusses plenoptic camera calibration and setup, assesses plenoptic imaging in a clinically relevant context, and in the context of other quantitative imaging technologies. We report the methods used for camera calibration, precision and accuracy results in an ideal and simulated surgical setting. Afterwards, we report performance during a surgical task. Test results showed the average precision of the plenoptic camera to be 0.90mm, increasing to 1.37mm for tissue across the calibrated FOV. The ideal accuracy was 1.14mm. The camera showed submillimeter error during a simulated surgical task.

  19. Marketing and clinical trials: a case study

    PubMed Central

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-01-01

    Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors. PMID:18028537

  20. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.

    PubMed

    Löfgren, Håkan; Engquist, M; Hoffmann, P; Sigstedt, B; Vavruch, L

    2010-03-01

    A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23

  1. A Framework and Model for Evaluating Clinical Decision Support Architectures

    PubMed Central

    Wright, Adam; Sittig, Dean F.

    2008-01-01

    In this paper, we develop a four-phase model for evaluating architectures for clinical decision support that focuses on: defining a set of desirable features for a decision support architecture; building a proof-of-concept prototype; demonstrating that the architecture is useful by showing that it can be integrated with existing decision support systems and comparing its coverage to that of other architectures. We apply this framework to several well-known decision support architectures, including Arden Syntax, GLIF, SEBASTIAN and SAGE PMID:18462999

  2. Clinical evaluation of 860 anterior and posterior lithium disilicate restorations: retrospective study with a mean follow-up of 3 years and a maximum observational period of 6 years.

    PubMed

    Fabbri, Giacomo; Zarone, Fernando; Dellificorelli, Gianluca; Cannistraro, Giorgio; De Lorenzi, Marco; Mosca, Alberto; Sorrentino, Roberto

    2014-01-01

    This study aimed to assess the clinical performance of lithium disilicate restorations supported by natural teeth or implants. Eight hundred sixty lithium disilicate adhesive restorations, including crowns on natural teeth and implant abutments, veneers, and onlays, were made in 312 patients. Parafunctional patients were included, but subjects with uncontrolled periodontitis and gingival inflammation were excluded. Veneers up to 0.5 mm thick were luted with flowable composite resin or light curing cements, while dual-curing composite systems were used with veneers up to 0.8 mm thick. Onlays up to 2 mm in thickness were luted with flowable composite resins or dual-curing composite cements. Crowns up to 1 mm in thickness were cemented with self-adhesive or dual-curing resin cements. The observational period ranged from 12 to 72 months, with a mean follow-up of 3 years. The mechanical and esthetic outcomes of the restorations were evaluated according to the modified California Dental Association (CDA) criteria. Data were analyzed with descriptive statistics. Twenty-six mechanical complications were observed: 17 porcelain chippings, 5 fractures, and 4 losses of retention. Structural drawbacks occurred mainly in posterior segments, and monolithic restorations showed the lowest number of mechanical complications. The clinical ratings of the successful restorations, both monolithic and layered, were satisfactory according to the modified CDA criteria for color match, porcelain surface, and marginal integrity. The cumulative survival rates of lithium disilicate restorations ranged from 95.46% to 100%, while cumulative success rates ranged from 95.39% to 100%. All restorations recorded very high survival and success rates. The use of lithium disilicate restorations in fixed prosthodontics proved to be effective and reliable in the short- and medium-term.

  3. Iranian Effective Clinical Nurse Instructor evaluation tool: Development and psychometric testing

    PubMed Central

    Shahsavari, Hooman; Yekta, Zohreh Parsa; Zare, Zahra; Sigaroodi, Abdolhossain Emami

    2014-01-01

    Background: Clinical education is the heart of the nursing education program. Effective nursing clinical instructors are needed for graduating the future qualified nurses. There is a well-developed body of knowledge about the effectiveness of clinical teaching and the instructors. However, translating this knowledge into a context-based evaluation tool for measuring the effectiveness of Iranian clinical nursing instructors remains a deficiency. The purpose of this study is to describe the development and psychometric testing process of an instrument to evaluate the characteristics of Iranian effective clinical nurse instructor. Materials and Methods: Following a precise review of Iranian literatures and expert consultation, 83 statements about the characteristics that make clinical nurse instructors effective were extracted. In the next phase, the psychometric properties of the instrument were established by looking at the content validity, face validity, and internal consistency. Content validity of the instrument was assessed based on the comments of an expert panel including 10 nursing faculty members. During this phase, 30 items of the instrument were omitted or merged. Face validity of the instrument was assured based on the advices of 10 nursing students and 10 nursing faculty members. Finally, in the pilot test, the data of 168 filled questionnaires were gathered and analyzed by an exploratory factor analysis to reduce the items and identify the factor structure of the instrument. Results: Through subsequent analyses, of the 83 items, 31 items were merged or omitted. At last, 52 retained items were divided into four subscales including student-centric behaviors, clinical performances, planning ability, and personality traits. The Cronbach's alpha level of the inventory was 0.96, with the value for each domain ranging from 0.87 to 0.94. Conclusions: Iranian Effective Clinical Nurse Instructor evaluation tool has acceptable psychometric properties and can be

  4. 77 FR 65698 - Prospective Grant of Exclusive Evaluation Option License: Pre-clinical Evaluation of Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-30

    ...: Pre- clinical Evaluation of Human Therapeutics Utilizing Ubiquitin Based Fusion Proteins With Apoptosis Modifying Proteins Such as BCL-XL AGENCY: National Institutes of Health, Public Health Service... an Extracellular BCL- x L Fusion Protein Inhibits Apoptosis'' (HHS Ref. No. E-073-...

  5. [The usefulness of platelet function evaluation in clinical practice].

    PubMed

    Elalamy, Ismail; Gkalea, Vasiliki; Gerotziafas, Grigorios; Ketatni, Hela; Hatmi, Mohamed

    2013-11-01

    Platelets play a pivotal role in the regulation of both thrombosis and haemostasis. Functional testing of platelet response has been exclusively used in the diagnosis and management of bleeding disorders. Recent advances of light transmission aggregometry and development of more useful devices have demonstrated the clinical utility to enlarge platelet function testing in patients with cardiovascular disease. The ex vivo measurement of residual platelet response seems, with some assays, predictive of adverse clinical events. Still a debate, it represents an emerging area of interest for both the clinician and the basic scientist. Heparin-induced thrombocytopenia diagnosis is also difficult and a functional assay is now available for an easier and rapid method to rule out such a life-threatening situation. This review article will describe the available methods of measuring platelet response and will discuss both the limitations and emerging data supporting the role of platelet function studies in clinical practice.

  6. An evaluation tool for collaborative clinical research centers.

    PubMed

    Tragus, Robin; Cody, Jannine D

    2013-06-01

    There is a need for metrics that describe the full range of services provided by a clinical research unit; given that services have expanded to include such things as investigator training, regulatory compliance monitoring, and budget negotiations. We developed a tool and methodology that allows tracking of these expanded services. This not only allowed us to more accurately describe the work of the research unit staff, but to monitor the status of a study across the entire study lifespan from the idea to the publication. In addition to measuring work, it allows us to anticipate future needs in clinical staff and expertise because we are involved very early in study planning. We also expect that by analyzing these data from many studies over time, we will identify process barriers that will direct future program improvement.

  7. Empirically supported psychological treatments: the challenge of evaluating clinical innovations.

    PubMed

    Church, Dawson; Feinstein, David; Palmer-Hoffman, Julie; Stein, Phyllis K; Tranguch, Anthony

    2014-10-01

    Clear and transparent standards are required to establish whether a therapeutic method is "evidence based." Even when research demonstrates a method to be efficacious, it may not become available to patients who could benefit from it, a phenomenon known as the "translational gap." Only 30% of therapies cross the gap, and the lag between empirical validation and clinical implementation averages 17 years. To address these problems, Division 12 of the American Psychological Association published a set of standards for "empirically supported treatments" in the mid-1990s that allows the assessment of clinical modalities. This article reviews these criteria, identifies their strengths, and discusses their impact on the translational gap, using the development of a clinical innovation called Emotional Freedom Techniques (EFT) as a case study. Twelve specific recommendations for updates of the Division 12 criteria are made based on lessons garnered from the adoption of EFT within the clinical community. These recommendations would shorten the cycle from the research setting to clinical practice, increase transparency, incorporate recent scientific advances, and enhance the capacity for succinct comparisons among treatments.

  8. Porcelain laminate veneers: Clinical survey for evaluation of failure

    PubMed Central

    Alhekeir, Diemah F.; Al-Sarhan, Rana A.; Al Mashaan, Abdulmohsen F.

    2014-01-01

    Objective To investigate the association of the failure of porcelain laminate veneers with factors related to the patient, material, and operator. Methods This clinical survey involved 29 patients (19 women and 10 men) and their dentists, including undergraduate and postgraduate dental students and dental interns. Two questionnaires were distributed to collect information from participants. All patients were clinically examined. Criteria for failure of the porcelain laminate veneers included color change, cracking, fracture, and/or debonding. Results A total of 205 porcelain laminate veneers were evaluated. All of the restorations were fabricated from IPS e.max Press and cemented with Variolink Veneer (Ivoclar Vivadent, Schaan, Principality of Liechtenstein) or RelyX veneer cement (3M ESPE, St. Paul, MN, USA). The preparations were generally located in enamel (58.6%), and most veneers had an overlapped design (89.7%). Ten patients (34.48%) showed veneer failure, most often in terms of color change (60%). Overall, 82.8% of patients were satisfied with their restorations. Conclusion Insufficient clinical skills or operator experience resulted in restoration failure in one-third of patients. PMID:25408598

  9. Evaluation of a clinical genetics service--a quality initiative.

    PubMed

    Elliott, Alison M; Chodirker, Bernard N; Bocangel, Patricia; Mhanni, Aizeddin A

    2014-10-01

    Paper-based surveys are an effective means of evaluating the quality of a clinical service. As part of ongoing quality improvement initiatives within our Genetics Program, new patients were invited to participate in a paper-based survey. Issues related to the quality of counseling based on educational/informational aspects (e.g. whether testing was explained fully, testing options, the meaning of normal/abnormal testing), competency, respect and nondirectiveness of counseling in addition to clinical environment/setting were evaluated. Data related to demographics, discipline seen within the program and whether the patient was seen by a physician or genetic counselor were also captured. Five hundred questionnaires were distributed. One hundred and forty-seven questionnaires were returned, with a response rate of 29.4 %. The majority of patients seen were prenatal (pregnant) patients and comprised a heterogeneous group including those seen for advanced maternal age and abnormal maternal serum screening. Overall, 98.6 % of respondents felt their appointment in genetics was a positive experience. Issues related to confidentiality, pros and cons of testing, meaning of an abnormal test result and time allotted for decision making were significantly different in some disciplines between genetic counselor and geneticist. However, when controlling for referral indication, these differences lost significance with the exception of issues relating to confidentiality and perceived time allotted to organize thoughts and questions. This survey provided valuable information to allow for improvement in the quality of the provision of service.

  10. Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine.

    PubMed

    Precioso, Alexander Roberto; Palacios, Ricardo; Thomé, Beatriz; Mondini, Gabriella; Braga, Patrícia; Kalil, Jorge

    2015-12-10

    Butantan Institute is a public Brazilian biomedical research-manufacturer center affiliated to the São Paulo State Secretary of Health. Currently, Butantan is one of the main public producers of vaccines, antivenoms, and antitoxins in Latin America. The partnership between Butantan and the National Institutes of Health (NIH) of the United Sates has been one of the longest and most successful partnerships in the development and manufacturing of new vaccines. Recently, Butantan Institute has developed and manufactured a lyophilized tetravalent live attenuated dengue vaccine with the four dengue viruses attenuated and licensed from the Laboratory of Infectious Diseases at The National Institutes of Allergy and Infectious Diseases (LID/NIAID/NIH). The objective of this paper is to describe the clinical evaluation strategies of a live attenuated tetravalent dengue vaccine (Butantan-DV) developed and manufactured by Butantan Institute. These clinical strategies will be used to evaluate the Butantan-DV Phase III trial to support the Butantan-DV licensure for protection against any symptomatic dengue caused by any serotype in people aged 2 to 59 years.

  11. Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism in healthy individuals without symptoms of arthritis: A randomized double-blind placebo-controlled clinical study

    PubMed Central

    Tomonaga, Akihito; Watanabe, Keita; Fukagawa, Mitsuhiko; Suzuki, Asahi; Kurokawa, Mihoko; Nagaoka, Isao

    2016-01-01

    The present study aimed to evaluate the effect of N-acetyl-glucosamine (GlcNAc) on the joint health of healthy individuals without arthritic symptoms. A randomized double-blind placebo-controlled clinical trial was performed to investigate the effect of oral administration of a GlcNAc-containing test supplement (low dose, 500 mg/day and high dose, 1,000 mg/day) on cartilage metabolism in healthy individuals with a mean age of 48.6±1.3 years (range, 23–64 years) by analyzing the ratio of type II collagen degradation to type II collagen synthesis using type II collagen degradation (C2C) and synthesis (PIICP) markers. The results indicated that the changes in C2C/PIICP ratios from the baseline were suppressed in the treated with low and high doses of GlcNAc, compared with the placebo group at week 16 during intervention. To further elucidate the effect of GlcNAc, subjects with impaired cartilage metabolism were evaluated. Notably, the changes in the C2C/PIICP ratios were markedly suppressed in the groups treated with low and high doses of GlcNAc at week 16. Finally, to exclude the effect of heavy body weight on joint loading, subjects weighing <70 kg with impaired cartilage metabolism were analyzed. Notably, the changes in the C2C/PIICP ratios were suppressed in the groups treated with low and high doses of GlcNAc at weeks 12 and 16. No test supplement-related adverse events were observed during or following the intervention. Together, these observations suggest that oral administration of GlcNAc at doses of 500 mg and 1,000 mg/day exhibits a chondroprotective effect on healthy individuals by reducing the C2C/PIICP ratio (relatively decreasing type II collagen degradation and increasing type II collagen synthesis) without any apparent adverse effects. PMID:27588069

  12. [Clinical studies with cefmenoxime in the field of pediatrics].

    PubMed

    Takimoto, M; Yoshioka, H; Maruyama, S; Sanae, N; Nagamatsu, I

    1982-10-01

    The present study was performed to evaluate the clinical effectiveness and safety of cefmenoxime (CMX), a new cephalosporin antibiotic for injection in the field of pediatrics. Thirty-one cases, including 2 cases with sepsis, 18 cases with respiratory tract infections and 7 cases with urinary tract infections, were given CMX at daily doses of 30 mg/kg to 125 mg/kg divided into 3 or 4 for 3 days to 13 days. Clinical responses were excellent in 16 cases, good in 9 cases and poor in 6 cases, the satisfactory response being 80.6%. No side effects and no abnormal laboratory findings relating to the drug were observed.

  13. [Clinical study on a new acetylsalicylic acid/paracetamol preparation with gastric acid resistant coating (Safapryn), and on two various phenylbutazone dosages in patients with primary chronic polyarthritis as based on a new evaluation method].

    PubMed

    Brooks, P M; Walker, J J; Lee, P; Bell, A M; Buchanan, W W; Fowler, P D; Anderson, J A

    1975-01-01

    The authors describe a simple non-crossover-blind test for the evaluation of subjective indices. A table for recording pains during the 14 days' study is described. The patient's satisfaction with the treatment and the number of days until withdrawal from the trial are recorded. The statistical procedure takes into consideration differences between the treatment groups and makes possible a valuable comparison with drugs tested in other clinical trials. The three dose schedules of antirheumatic treatment were tested on 122 patients and the results compared with those of 342 patients treated with the 6 other antirheumatic drugs (enteric-coated aspirin, paracetamol, indomethacin, flurbiprofen, mefenamic acid, and prednisolone) and those of 41 patients who received placebos. The results show that Safapryn (3,6 g aspirin + 3.0 g paracetamol daily) compared with 3.9 g enteric coated aspirin does not offer any advantage in its analgesic effect, although it gives rise to fewer side effects. Phenylbutazone (3000 mg) was almost as effective as 15 mg prednisolone daily. Between the effects of this dosage of phenylbutazone and other non-steroidal antirheumatic drugs, however, no significant difference could be detected. 50 mg phenylbutazone daily and placebo treatment could not be distinguished. The authors thank the Arthritis and Rheumatism Council for Research in Great Britain for its financial support. One of the authors (PL) was a Merck, Sharp, and Dohme Research Fellow and another one (PMB) received a Robins research scholarship.

  14. The development and evaluation of a clinical test of surgical resident proficiency.

    PubMed

    Anderson, B O; Sun, J H; Moore, E E; Thompson, L L; Harkin, A H; Bartle, E J

    1989-08-01

    The two purposes of this study were to develop a clinical test of surgical resident proficiency and to compare this clinical test with currently applied methods of resident evaluation. Appendicitis is a common surgical disease, and its accurate diagnosis depends largely on clinical acumen. Ten third-year surgical residents prospectively evaluated 107 patients admitted because of suspected appendicitis. After taking a history, performing a physical examination, and reviewing laboratory data, these residents were asked to state, as a percentage, the likelihood that each patient had appendicitis. Sixty-three patients had appendicitis documented by pathologic inspection after appendectomy. Forty-four patients did not have appendicitis, as was determined by operation (17) or by in-house observation and resolution of abdominal pain (27). These outcomes were used to calculate a diagnostic ability score (DAS) for each resident. Residents were evaluated by standard methods including in-service examinations and monthly evaluations by the attending staff. Residents were also evaluated by nonstandard, but potentially useful, neuropsychologic and psychologic tests, including the trail making test, the Ravens progressive matrices test, the paced auditory serial addition test (PASAT), the grooved pegboard test of manual dexterity, and the profile of mood states (POMS) psychologic questionnaire. Cumulative scores were calculated and compared by multiple regression with coefficient variance analysis. The correlation (R2) of DAS with standard evaluation techniques was as follows: In-service (0.055), faculty (0.508), trails (-0.293), Ravens (0.028), PASAT (0.251), dexterity (0.432), POMS (0.381). We found that (1) the DAS is a discriminating clinical test; (2) the DAS correlates with subjective faculty evaluation; and (3) the DAS does not correlate with in-service examination scores. We conclude that faculty evaluation remains the best currently applied test of surgical resident

  15. [Clinical studies of pediatric malabsorption syndromes].

    PubMed

    Hosoyamada, Takashi

    2006-11-01

    Multiple cases with various types of pediatric malabsorption syndromes were evaluated. The clinical manifestations, laboratory findings, pathophysiology, and histopathological descriptions of each patient were analyzed in an effort to clear the pathogenesis of the malabsorption syndromes and the treatments were undertaken. The cases studied, included one patient with cystic fibrosis, two with lactose intolerance with lactosuria (Durand type), one with primary intestinal lymphangiectasia, two with familial hypobetalipoproteinemia, one with Hartnup disease, one with congenital chroride diarrhea, one with acrodermatitis enteropathica, one with intestinal nodular lymphoid hyperplasia (NLH), five with intractable diarrhea of early infancy and four with glycogenosis type Ia. Each case description and outcome is described below: 1. A 15-year-old Japanese boy with cystic fibrosis presented with severe symptoms, including pancreatic insufficiency, bronchiectasis, pneumothorax and hemoptysis. His prognosis was poor. Analysis of the CFTR genes of this patient revealed a homozygous large deletion from intron 16 to 17b. 2. In the sibling case of Durand type lactose intolerance, the subjects'disaccaridase activity of the small bowel, including lactase, were within normal limits. The results of per oral and per intraduodenal lactose tolerance tests confirmed lactosuria in both. These observations suggested, not only an abnormal gastric condition, but also duodenal and intestinal mucosal abnormal permeability of lactose. 3. In the case of primary intestinal lymphangiectasia, the subject had a lymphedematous right arm and hand, a grossly coarsened mucosal pattern of the upper gastrointestinal tract (identified via radiologic examination) and the presence of lymphangiectasia (confirmed via duodenal mucosal biopsy). The major laboratory findings were hypoalbuminemia, decreased immunoglobulin levels and lymphopenia resulting from loss of lymph fluid and protein into the gastro

  16. The reliability of British Sign Language and English versions of the Clinical Outcomes in Routine Evaluation--Outcome Measure with d/Deaf populations in the UK: an initial study.

    PubMed

    Rogers, Katherine; Evans, Chris; Campbell, Malcolm; Young, Alys; Lovell, Karina

    2014-05-01

    Previous research has argued that the mental well-being of d/Deaf people is poorer than that of hearing populations. However, there is a paucity of valid and reliable mental health instruments in sign language that have been normalised with d/Deaf populations. The aim of this study was to determine the reliability of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) with d/Deaf populations. A British Sign Language (BSL) version was produced using a team approach to forward translation, and a back-translation check. The CORE-OM was incorporated into an online survey, to be completed in either BSL or English, as preferred by the participant. From December 2010 to March 2011, data were collected from 136 d/Deaf people. Cronbach's α was used to measure the internal consistency of items in the CORE-OM. Comparisons were made between versions, including comparisons with the non-clinical hearing population (not in receipt of mental health services) in a previous study. The reliability of the overall score, as well as the non-risk items in both the BSL and English versions, was satisfactory. The internal reliability of each domain in the BSL version was good (Cronbach's α > 0.70) and comparable to the English version in the hearing population. This was true for most domains of the CORE-OM in the English version completed by d/Deaf people, although the Functioning domain had a relatively low α of 0.79 and the Risk domain had an α of only 0.66 This raised the question whether it is advisable to use a mental health assessment with d/Deaf populations that has been standardised with hearing populations. Nevertheless, this study has shown that it is possible to collect data from d/Deaf populations in the UK via the web (both in BSL and English), and an online BSL version of the CORE-OM is recommended for use with Deaf populations in the community.

  17. Interim Outcomes Assessment of the Comprehensive Clinical Performance Grid for Student Evaluation.

    ERIC Educational Resources Information Center

    Tolls, Dorothy Bazzinotti; Carlson, Nancy; Wilson, Roger; Richman, Jack

    2001-01-01

    Assessed the viability of the Comprehensive Clinical Performance Grid for Student Evaluation, introduced at The New England College of Optometry in 1996 in clinical student assessment. Analyzed faculty and student feedback and consistency with previous evaluations, between evaluators, and between clinical sites and tracts. Found satisfaction with…

  18. Clinical evaluation of a silicone coated hollow fiber oxygenator.

    PubMed

    Shimono, T; Shomura, Y; Tani, K; Shimamoto, A; Hioki, I; Tokui, T; Onoda, K; Takao, M; Shimpo, H; Yada, I

    1997-01-01

    In this article, the clinical experience with a cardiopulmonary bypass (CPB) using a newly developed hollow fiber oxygenator with an ultra-thin layer of silicone is reported. A comparative study of biocompatibility between the new oxygenator and a heparin coated oxygenator is also described. The CPB was performed with a silicone coated oxygenator, Mera Excelung Binding Prim HPO 15 H-C (Group I, n = 6) or Binding Prim HPO 25 H-C (Group II, n = 10) (Senko Medical Instrument Mfg., Tokyo, Japan). Air could be vented through the silicone coated hollow fibers, and it was easy to prime the circuits. The CPB duration was 101 +/- 37 min and 170 +/- 64 min for Groups I and II, respectively. There were no deaths and no complications from CPB. Partial arterial pressure of O2 levels 60 minutes after the start of CPB were 529 +/- 28 mm Hg and 529 +/- 28 mmHg for Group I and II, respectively. Partial arterial pressure of CO2 levels 60 min after the start of CPB were 36.4 +/- 4.6 mmHg and 39.4 +/- 4.4 mmHg, respectively. Plasma free hemoglobin at 60 min was 33.5 +/- 17.2 mg/ dL and 46.7 +/- 26.1 mg/dL for Groups I and II, respectively. As an evaluation of biocompatibility, the effects of the new oxygenator on platelet activation (GP Ib, IIb/IIIa), coagulation (TAT), fibrinolysis (PIC), and inflammatory response (C3a, granulocyte elastase) were investigated during CPB and comparing to those of the heparin coated oxygenator. There were no significant differences in GP Ib, GP IIb/IIa, TAT, PIC, and granulocyte elastase between the two oxygenators. However, 60 min after the start of CPB, the C3a was significantly lower for the new oxygenator group than for the heparin coated oxygenator group (p < 0.03). The new oxygenator showed good gas transfer, low hemolysis, and good biocompatibility. Because of its durability and good biocompatibility, the new oxygenator was determined to be suitable for prolonged extra corporeal circulation.

  19. [Clinical and pharmacokinetic evaluation of ceftriaxone in children].

    PubMed

    Fujita, K; Sakata, H; Murono, K; Yoshioka, H; Maruyama, S; Sanae, N

    1984-12-01

    Twenty-eight pediatric patients were treated with ceftriaxone (Ro 13-9904, CTRX) in the doses ranging from 8.75 to 25 mg/kg every 12 hours for 3.5 to 11.5 days, and the clinical efficacy and side effects were evaluated. Among the 21 children with bacterial infections including pneumonia, acute bronchitis, otitis media, tonsillitis and urinary tract infections, the results were excellent in 9, good in 11, and fair in 1 patient. Out of the 28 patients, 2 patients had diarrhea, 3 patients had slightly elevated serum concentrations of transaminases, and 2 patients showed eosinophilia. The serum concentrations of CTRX in 5 children ranged from 50.0 to 93.8 micrograms/ml (mean 75.0 micrograms/ml) at 15 minutes and from 10.2 to 15.6 micrograms/ml (mean 13.4 micrograms/ml at 6 hours after 10 mg/kg intravenous bolus injection of CTRX. The serum half-lives were from 2.61 to 8.30 hours (mean 6.16 hours), and urinary recovery rates were from 43.3 to 58.0% (mean 48.5%) during 0-6 hours and from 52.0 to 66.1% (mean 59.4%) during 0-12 hours. After 20 mg/kg intravenous bolus injection of CTRX in 4 children, the serum concentrations of CTRX were from 118.8 to 162.5 micrograms/ml (mean 139.1 micrograms/ml) at 15 minutes and from 18.0 to 21.1 micrograms/ml (mean 19.2 micrograms/ml) at 6 hours. The serum half-lives were 4.07 to 6.34 hours (mean 5.13 hours), and urinary recovery rates were 38.6 to 51.1% (mean 45.4%) during 0-6 hours and from 54.8 to 64.0% (mean 59.0%) during 0-12 hours. Patients with impairment of renal function were excluded from this pharmacokinetic study.

  20. Clinical characteristics and therapeutic evaluation of childhood myasthenia gravis

    PubMed Central

    YANG, ZHI-XIAO; XU, KAI-LI; XIONG, HUI

    2015-01-01

    This study aimed to analyze the clinical characteristics, classification and treatment of childhood myasthenia gravis (MG) and address the prognosis through follow-up. The clinical data of 135 children with MG were grouped according to clinical type and therapeutic drugs, retrospectively analyzed and prospectively monitored. Of the 135 MG patients, 85.2% had type I (ocular type), with only 4.2% progressing to systemic MG; 13.4% had type II (general type); and 1.5% had type III (fulminating type). Relapse occurred in 46.1% of the 102 patients that were followed up. The positive rate for the primary acetylcholine receptor antibody was 40.19%, without significant differences among clinical subtypes. The positive rate of the repetitive nerve stimulation frequency test by electromyography was 37.97%. Decreased expression of CD4+, CD8+, or CD3+ was present in 71% of the patients. Thymic hyperplasia was present in 5.93% of the patients, while 1.48% had thymoma. Steroid treatment was effective in the majority of the patients. Ocular type MG was common in this cohort of patients. The incidence and mortality of myasthenia crisis were low, the presence of concurrent thymoma was rare and only a limited number of children developed neurological sequelae. PMID:25780436

  1. [Evaluation of clinical competence in the nursing profession].

    PubMed

    Solà Pola, Montserrat; Molins Mesalles, Ainhoa; Martínez Carretero, Josep Maria

    2005-01-01

    The quality of health services depends on the competence of the health service professionals. It is essential to define and evaluate professional competences in order to improve professional development, ensure the quality of, and manage, professionals in terms of their competences. To do so, it is necessary to utilize a combination of different methods. The evaluation of the diverse stages related to nursing--at the end of undergraduate studies, postgraduate studies or specialization, and during independent work--has different proposals, content and methods; and the institutions implicated in these stages should make themselves responsible to acquire the professional which society needs. Since 1994, more than 150 projects have been carried out in Catalonia which confirm the validity, trustworthiness, acceptability and utility of these evaluative methods in undergraduate and postgraduate studies and in the selection and accreditation of professionals.

  2. Upper stage technology evaluation studies

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Studies to evaluate advanced technology relative to chemical upper stages and orbit-to-orbit stages are reported. The work described includes: development of LH2/LOX stage data, development of data to indicate stage sensitivity to engine tolerance, modified thermal routines to accommodate storable propellants, added stage geometries to computer program for monopropellant configurations, determination of the relative gain obtainable through improvement of stage mass fraction, future propulsion concepts, effect of ultrahigh chamber-pressure increases, and relative gains obtainable through improved mass fraction.

  3. Asphyxia in the Newborn: Evaluating the Accuracy of ICD Coding, Clinical Diagnosis and Reimbursement: Observational Study at a Swiss Tertiary Care Center on Routinely Collected Health Data from 2012-2015

    PubMed Central

    Rimle, Carole; Zwahlen, Marcel; Triep, Karen; Raio, Luigi; Nelle, Mathias

    2017-01-01

    Background The ICD-10 categories of the diagnosis “perinatal asphyxia” are defined by clinical signs and a 1-minute Apgar score value. However, the modern conception is more complex and considers metabolic values related to the clinical state. A lack of consistency between the former clinical and the latter encoded diagnosis poses questions over the validity of the data. Our aim was to establish a refined classification which is able to distinctly separate cases according to clinical criteria and financial resource consumption. The hypothesis of the study is that outdated ICD-10 definitions result in differences between the encoded diagnosis asphyxia and the medical diagnosis referring to the clinical context. Methods Routinely collected health data (encoding and financial data) of the University Hospital of Bern were used. The study population was chosen by selected ICD codes, the encoded and the clinical diagnosis were analyzed and each case was reevaluated. The new method categorizes the diagnoses of perinatal asphyxia into the following groups: mild, moderate and severe asphyxia, metabolic acidosis and normal clinical findings. The differences of total costs per case were determined by using one-way analysis of variance. Results The study population included 622 cases (P20 “intrauterine hypoxia” 399, P21 “birth asphyxia” 233). By applying the new method, the diagnosis asphyxia could be ruled out with a high probability in 47% of cases and the variance of case related costs (one-way ANOVA: F (5, 616) = 55.84, p < 0.001, multiple R-squared = 0.312, p < 0.001) could be best explained. The classification of the severity of asphyxia could clearly be linked to the complexity of cases. Conclusion The refined coding method provides clearly defined diagnoses groups and has the strongest effect on the distribution of costs. It improves the diagnosis accuracy of perinatal asphyxia concerning clinical practice, research and reimbursement. PMID:28118380

  4. Assessing students' English language proficiency during clinical placement: A qualitative evaluation of a language framework.

    PubMed

    San Miguel, Caroline; Rogan, Fran

    2015-06-01

    The increase in nursing students for whom English is an additional language requires clinical facilitators to assess students' performance regarding clinical skills, nursing communication and English language. However, assessing language proficiency is a complex process that is often conflated with cultural norms and clinical skills, and facilitators may lack confidence in assessing English language. This paper discusses an evaluation of a set of guidelines developed in a large metropolitan Australian university to help clinical facilitators make decisions about students' English language proficiency. The study found that the guidelines were useful in helping facilitators assess English language. However, strategies to address identified language problems needed to be incorporated to enable the guidelines to also be used as a teaching tool. The study concludes that to be effective, such guidelines need embedding within a systematic approach that identifies and responds to students who may be underperforming due to a low level of English language proficiency.

  5. Diagnosis of cystocele--the correlation between clinical and radiological evaluation.

    PubMed

    Altman, Daniel; Mellgren, Anders; Kierkegaard, Jonas; Zetterström, Jan; Falconer, Christian; López, Annika

    2004-01-01

    In patients with genital prolapse involving several compartments simultaneously, radiologic investigation can be used to complement the clinical assessment. Contrast medium in the urinary bladder enables visualization of the bladder base at cystodefecoperitoneography (CDP). The aim of the present study was to evaluate the correlation between clinical examination using the Pelvic Organ Prolapse Quantification system (POP-Q) and CDP. Thirty-three women underwent clinical assessment and CDP. Statistical analysis using Pearson's correlation coefficient ( r) demonstrated a wide variability between the current definition of cystocele at CDP and POP-Q ( r=0.67). An attempt to provide an alternative definition of cystocele at CDP had a similar outcome ( r=0.63). The present study demonstrates a moderate correlation between clinical and radiologic findings in patients with anterior vaginal wall prolapse. It does not support the use of bladder contrast at radiologic investigation in the routine preoperative assessment of patients with genital prolapse.

  6. Evaluation of regional and whole gut motility using the wireless motility capsule: relevance in clinical practice

    PubMed Central

    Tran, Khoa; Brun, Rita

    2012-01-01

    The wireless motility capsule (WMC) is an ambulatory noninvasive and nonradioactive diagnostic sensor that continuously samples intraluminal pH, temperature, and pressure as it moves through the gastrointestinal (GI) tract. This review summarizes the data obtained in clinical trials with the WMC and discusses its role in clinical practice. The United States Food and Drug Administration has approved the SmartPill GI monitoring system for the evaluation of gastric emptying time in patients with suspected gastroparesis, the evaluation of colonic transit time in patients with suspected chronic constipation, and for the characterization of pressure profiles from the antrum and duodenum. Clinical studies have shown that WMC-measured GI transit times can distinguish patients with motility abnormalities similarly to conventional testing. However, the WMC offers the advantage of providing a full GI-tract profile, enabling the detection of multiregional GI transit abnormalities in patients with suspected upper or lower GI dysmotility. The WMC also characterizes pressure profiles of the GI tract and impaired pressure profile limits are reported for the antrum and duodenum. In comparison with manometry, interpretations of pressure measurements obtained by the WMC are limited by an inability to detect a peristaltic pressure wave front, and further investigation is required to develop clinical applications. Clinical studies with the WMC indicated that it should be considered for the evaluation of regional and whole gut transit time in patients with suspected upper or lower dysmotility, particularly if there are concerns about multiregional dysmotility. PMID:22778790

  7. Use of anecdotal notes by clinical nursing faculty: a descriptive study.

    PubMed

    Hall, Mellisa A; Daly, Barbara J; Madigan, Elizabeth A

    2010-03-01

    Although the use of anecdotal notes by faculty to document clinical performance is thought to be a common practice, no empirical study of this evaluation tool has been conducted. To investigate the frequency and pattern of use, a faculty questionnaire was developed using the Context, Input, Process, Product (CIPP) evaluation model as a framework. The model was adapted to focus on clinical nursing education. Sixty-four nursing faculty from six schools participated in the regional study. A descriptive design was used to collect quantitative data from clinical faculty. Findings indicated that 97% of clinical faculty use anecdotal notes during the student evaluation process, and the majority of faculty do so on a weekly basis. Based on faculty feedback and the CIPP evaluation model, a clinical nursing faculty tool was developed after study completion to support clinical faculty in note use.

  8. Aetiopathological and clinical study of erythroderma.

    PubMed

    Prakash, B V S; Sirisha, N L; Satyanarayana, V V V; Sridevi, L; Ramachandra, B V

    2009-02-01

    Erythoderma first described by Hebra in 1868 is a reaction pattern, characterised by generalised and confluent erythema with desquamation affecting more than 90% of body surface and is usually accompanied by systemic manifestation including some metabolic changes. Tile study was envisaged to assess their profile of aetiology, clinical features and to correlate with histopathological findings. Twenty-four patients (18 males and 6 females) with erythroderma were considered for the study. All patients were hospitalised, detailed history was taken and were subjected to relevant investigations--haemogram, serum proteins, liver and renal function tests, routine and microscopic urine tests, HIV screening, x-ray chest, ultrasound abdomen, FNAC of enlarged lymph nodes and skin biopsy. The age group affected ranged between 7 and 70 years, peak incidence between 50 and 60 years. The male to female ratio was 3:1. Scaling, erythema and pruritus were predominant clinical manifestations. In 12 clinically suspected psoriatic erythroderma, only in 6 cases the histopathological features were correlated to psoriasis and remaining showed non-specific chronic dermatitis. Two patients were found to be HIV-positive. There is good clinicopathological correlation in erythroderma caused by lichen planus, atopic dermatitis, seborroeic dermatitis, non-bullous congenital ichthyosiform erythroderma. Drugs were found to be aetiological factor in 3 cases. The study was conducted to assess variations in clinical, aetiological and histopathological profile of erythroderma. The present series had high percentage of erythroderma secondary to preexisting dermatoses. The onset of disease was insidious except in drug-induced erythroderma where it was acute.

  9. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice

    PubMed Central

    Mosca, M.; Tani, C.; Aringer, M.; Bombardieri, S.; Boumpas, D.; Cervera, R.; Doria, A.; Jayne, D.; Khamashta, M. A.; Kuhn, A.; Gordon, C.; Petri, M.; Schneider, M.; Shoenfeld, Y.; Smolen, J. S.; Talarico, R.; Tincani, A.; Ward, M. M.; Werth, V. P.; Carmona, L.

    2014-01-01

    The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR Recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed. PMID:21224016

  10. DNA Damage in Chronic Kidney Disease: Evaluation of Clinical Biomarkers

    PubMed Central

    Schupp, Nicole; Stopper, Helga; Heidland, August

    2016-01-01

    Patients with chronic kidney disease (CKD) exhibit an increased cancer risk compared to a healthy control population. To be able to estimate the cancer risk of the patients and to assess the impact of interventional therapies thereon, it is of particular interest to measure the patients' burden of genomic damage. Chromosomal abnormalities, reduced DNA repair, and DNA lesions were found indeed in cells of patients with CKD. Biomarkers for DNA damage measurable in easily accessible cells like peripheral blood lymphocytes are chromosomal aberrations, structural DNA lesions, and oxidatively modified DNA bases. In this review the most common methods quantifying the three parameters mentioned above, the cytokinesis-block micronucleus assay, the comet assay, and the quantification of 8-oxo-7,8-dihydro-2′-deoxyguanosine, are evaluated concerning the feasibility of the analysis and regarding the marker's potential to predict clinical outcomes. PMID:27313827

  11. Clinical evaluation of Varnya Gana Lepa in Vyanga (melasma)

    PubMed Central

    Pallavi, G.; Gupta, K. L. Virupaksha; Shreevathsa, M.; Chate, Vasudev A.; Balakrishna, D. L.

    2015-01-01

    Background: Vyanga type of Kshudra Roga, characterised by Niruja (painless), Shyava Varna Mandalas (bluish black patches) occurring especially on the face. The clinical features correlate with melasma, which is an acquired chronic hyperpigmentation disorder, usually seen in women of childbearing age. The drugs which constitute the Varnya Gana Lepa bestow the normal Varna (color) by virtue of their qualities and actions. Aim: To determine the efficacy of Varnya Gana Lepa in the management of Vyanga. Materials and Methods: The study was a single armed clinical trial in which total 40 patients of Vyanga belonging to the age group of 16–60 years were enrolled. Paste for external application was prepared by mixing the fine powders of 10 drugs (in equal quantity) of Varnya Gana with lukewarm water and advised to apply Lepa twice daily for 15 days on affected part. The different parameters such as skin color, lesion color, texture-dryness/oiliness, luster, number and size of the lesions, darkness, area and homogeneity of lesion, itching, burning sensation, and melasma area severity index (MASI) score were assessed. Results: There was statistically significant improvement in MASI scores, but in overall assessment, 64.5% patients had mild improvement. Clinical improvement was more evident in darkness parameter when compared to other parameters. Conclusion: The study concludes that Varnya Gana Lepa is a safe and effective formulation in the management of Vyanga (melasma). PMID:27011715

  12. Changes in local clinical practice following an experiment in medical care: evaluation of evaluation.

    PubMed

    Adler, M W

    1978-06-01

    The changes in clinical practice following a randomised controlled trial of early discharge for inguinal hernia and varicose veins are reviewed. A significant reduction in mean length of stay was recorded in the study area between 1970 (the year before the start of the study) and 1975 (two complete years after the study). This change was not found in two adjacent health districts.

  13. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer

    PubMed Central

    Quenel-Tueux, Nathalie; Debled, Marc; Rudewicz, Justine; MacGrogan, Gaetan; Pulido, Marina; Mauriac, Louis; Dalenc, Florence; Bachelot, Thomas; Lortal, Barbara; Breton-Callu, Christelle; Madranges, Nicolas; de Lara, Christine Tunon; Fournier, Marion; Bonnefoi, Hervé; Soueidan, Hayssam; Nikolski, Macha; Gros, Audrey; Daly, Catherine; Wood, Henry; Rabbitts, Pamela; Iggo, Richard

    2015-01-01

    Background: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment. Methods: One hundred and twenty post-menopausal patients were randomised to receive 1 mg anastrozole (61 patients) or 500 mg fulvestrant (59 patients) for 6 months. Genomic DNA copy number profiles were generated for a subgroup of 20 patients before and after treatment. Results: A total of 108 patients were evaluable for efficacy and 118 for toxicity. The objective response rate determined by clinical palpation was 58.9% (95% CI=45.0–71.9) in the anastrozole arm and 53.8% (95% CI=39.5–67.8) in the fulvestrant arm. The breast-conserving surgery rate was 58.9% (95% CI=45.0–71.9) in the anastrozole arm and 50.0% (95% CI=35.8–64.2) in the fulvestrant arm. Pathological responses >50% occurred in 24 patients (42.9%) in the anastrozole arm and 13 (25.0%) in the fulvestrant arm. The Ki-67 score fell after treatment but there was no significant difference between the reduction in the two arms (anastrozole 16.7% (95% CI=13.3–21.0) before, 3.2% (95% CI=1.9–5.5) after, n=43; fulvestrant 17.1% (95%CI=13.1–22.5) before, 3.2% (95% CI=1.8–5.7) after, n=38) or between the reduction in Ki-67 in clinical responders and non-responders. Genomic analysis appeared to show a reduction of clonal diversity following treatment with selection of some clones with simpler copy number profiles. Conclusions: Both anastrozole and fulvestrant were effective and well-tolerated, enabling breast-conserving surgery in over 50% of patients. Clonal changes consistent with clonal selection by the treatment were seen in a subgroup of patients. PMID:26171933

  14. Technology-Assisted Patient Access to Clinical Information: An Evaluation Framework for Blue Button

    PubMed Central

    Nazi, Kim M; Luger, Tana M; Amante, Daniel J; Smith, Bridget M; Barker, Anna; Shimada, Stephanie L; Volkman, Julie E; Garvin, Lynn; Simon, Steven R; Houston, Thomas K

    2014-01-01

    Background Patient access to clinical information represents a means to improve the transparency and delivery of health care as well as interactions between patients and health care providers. We examine the movement toward augmenting patient access to clinical information using technology. Our analysis focuses on “Blue Button,” a tool that many health care organizations are implementing as part of their Web-based patient portals. Objective We present a framework for evaluating the effects that technology-assisted access to clinical information may have on stakeholder experiences, processes of care, and health outcomes. Methods A case study of the United States Department of Veterans Affairs' (VA) efforts to make increasing amounts of clinical information available to patients through Blue Button. Drawing on established collaborative relationships with researchers, clinicians, and operational partners who are engaged in the VA’s ongoing implementation and evaluation efforts related to Blue Button, we assessed existing evidence and organizational practices through key informant interviews, review of documents and other available materials, and an environmental scan of published literature and the websites of other health care organizations. Results Technology-assisted access to clinical information represents a significant advance for VA patients and marks a significant change for the VA as an organization. Evaluations of Blue Button should (1) consider both processes of care and outcomes, (2) clearly define constructs of focus, (3) examine influencing factors related to the patient population and clinical context, and (4) identify potential unintended consequences. Conclusions The proposed framework can serve as a roadmap to guide subsequent research and evaluation of technology-assisted patient access to clinical information. To that end, we offer a series of related recommendations. PMID:24675395

  15. Clinical cardiac regenerative studies in children

    PubMed Central

    Pavo, Imre J; Michel-Behnke, Ina

    2017-01-01

    Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients. We review here the available literature data, searching the MEDLINE, Google Scholar and EMBASE database for completed, and www.clinicaltrials.gov homepage for ongoing studies involving pediatric cardiac regeneration reports. Because of difficulties conducting randomized blinded clinical trials in pediatric patients, mostly case reports or cohort studies with a limited number of individuals have been published in the field of pediatric regenerative cardiology. The majority of pediatric autologous cell transplantations into the cardiac tissue have been performed in critically ill children with severe or terminal heart failure. Congenital heart disease, myocarditis, and idiopathic hypertrophic or dilated cardiomyopathy leading to congestive heart failure are some possible areas of interest for pediatric cardiac regeneration therapy. Autologous bone marrow mononuclear cells, progenitor cells, or cardiospheres have been applied either intracoronary or percutaneously intramyocardially in severely ill children, leading to a reported clinical benefit of cell-based cardiac therapies. In conclusion, compassionate use of autologous stem cell administration has led to at least short-term improvement in heart function and clinical stability in the majority of the critically ill pediatric patients. PMID:28289528

  16. Clinical cardiac regenerative studies in children.

    PubMed

    Pavo, Imre J; Michel-Behnke, Ina

    2017-02-26

    Although the incidence of pediatric heart failure is low, the mortality is relatively high, with severe clinical symptoms requiring repeated hospitalization or intensive care treatment in the surviving patients. Cardiac biopsy specimens have revealed a higher number of resident human cardiac progenitor cells, with greater proliferation and differentiation capacity, in the neonatal period as compared with adults, demonstrating the regeneration potential of the young heart, with rising interest in cardiac regeneration therapy in critically ill pediatric patients. We review here the available literature data, searching the MEDLINE, Google Scholar and EMBASE database for completed, and www.clinicaltrials.gov homepage for ongoing studies involving pediatric cardiac regeneration reports. Because of difficulties conducting randomized blinded clinical trials in pediatric patients, mostly case reports or cohort studies with a limited number of individuals have been published in the field of pediatric regenerative cardiology. The majority of pediatric autologous cell transplantations into the cardiac tissue have been performed in critically ill children with severe or terminal heart failure. Congenital heart disease, myocarditis, and idiopathic hypertrophic or dilated cardiomyopathy leading to congestive heart failure are some possible areas of interest for pediatric cardiac regeneration therapy. Autologous bone marrow mononuclear cells, progenitor cells, or cardiospheres have been applied either intracoronary or percutaneously intramyocardially in severely ill children, leading to a reported clinical benefit of cell-based cardiac therapies. In conclusion, compassionate use of autologous stem cell administration has led to at least short-term improvement in heart function and clinical stability in the majority of the critically ill pediatric patients.

  17. Evaluation of the William S. Hall Psychiatric Institute Clinical Psychology Internship: a replication and extension.

    PubMed

    Stader, Sandra R; Myers, DeRosset; Forand, Angela Q; Holmes, George R; McNulty, George F; Frey, Linda; Bolton, Staci S

    2010-12-01

    This study extends three earlier investigations involving participants who completed their predoctoral clinical psychology internship at the William S. Hall Psychiatric Institute. Intern graduates (N = 37) evaluated how effectively their internship training prepared them for seven aspects of their current work as practicing psychologists. Participants also rated the relevancy of 24 different internship training experiences to their current work and how much these experiences contributed to their development as clinical psychologists. The present study, in conjunction with the three previous studies, covers most of the 40-year period since the inception of the internship program. Analysis of the current data indicates the internship has improved over time and was deemed an exceptional training experience by its graduates. Findings may be of particular interest to internship directors and faculty interested in improving their training program and those who plan to conduct a self-study to maintain their accreditation for clinical psychology internship.

  18. Second Mesiobuccal Canal Treatment in a Predoctoral Dental Clinic: A Retrospective Clinical Study.

    PubMed

    Coelho, Marcelo Santos; Parker, Jeffrey M; Tawil, Peter Z

    2016-06-01

    The aim of this retrospective clinical study was to evaluate the location and treatment of second canals in mesiobuccal roots (MB2) of first and second maxillary molars in a predoctoral endodontic clinic by the graduating classes of 2008 to 2015. These results were compared to similar clinical studies. Included in the study were 368 root canal treatments performed by 310 third- and fourth-year dental students at one U.S. dental school. All cases were done under faculty supervision, and the students were instructed to use dental loupe magnification. Students' evaluation sheets were used to deteremine the total MB2 canals treated in first and second maxillary molars. The results showed that, overall, 72.55% of the teeth had an MB2 canal treated. The frequency was higher in first molars (75.91%) than in second molars (56.92%) (p<0.05). Third-year students were able to detect 39 MB2 canals in 57 maxillary molars (68.42%), while fourth-year students detected 228 MB2 canals in 311 teeth (73.31%) (p>0.05). Under proper supervision by experienced endodontists, these dental students were capable of treating MB2 canals in maxillary molars. The frequency of MB2 canals located and treated by dental students with the assistance of experienced professionals was higher in first than in second molars. No significant difference was found between third- and fourth-year students. The incidence of MB2 canals located and treated in this study was found to be similar to that in other clinical studies.

  19. Clinical evaluation of a novel respiratory rate monitor.

    PubMed

    Lee, Peter J

    2016-04-01

    Respiratory rate has been shown to be an important predictor of cardiac arrest, respiratory adverse events and intensive care unit admission and has been designated a vital sign. However it is often inadequately monitored in hospitals. We test the hypothesis that RespiraSense, a piezoelectric-based novel respiratory rate (RR) monitor which measures the differential motion of the chest and abdomen during respiratory effort, is not inferior to commonly used methods of respiratory rate measurement. Respiratory rate was compared between the developed RespiraSense device and both electrocardiogram and direct observation by nursing staff. Data was collected from 48 patients admitted to the post-anaesthesia care unit in a tertiary level hospital. The primary outcome measure was difference in average RR calculated over a 15 min interval between (1) RespiraSense and ECG and (2) RespiraSense and nurses' evaluation. The secondary outcome measure was the correlation between the respiratory rates measured using these three methods. The 95 % confidence interval for the difference in average RR between RespiraSense and ECG was calculated to be [-3.9, 3.1]. The 95 % confidence interval for the difference in average RR between RespiraSense and nurses' evaluation was [-5.5, 4.3]. We demonstrate a clinically relevant agreement between RR monitored by the RespiraSense device with both ECG-derived and manually observed RR in 48 post-surgical patients in a PACU environment.

  20. A clinical evaluation of bleaching using whitening wraps and strips.

    PubMed

    Matis, Bruce A; Cochran, Michael; Wang, Ge; Franco, Miguel; Eckert, George J; Carlotti, Ronald J; Bryan, Christopher

    2005-01-01

    This study evaluated the degree of color change of teeth and the sensitivities of teeth and gums in an in vivo study. Ranir Whitening Wraps (WW2) and Crest Whitestrips Premium (WP2) were used twice a day and Ranir Whitening Wraps (WW1) were used once a day. Color evaluations occurred at baseline, after five and seven-day use of bleaching agent and 14 days post-bleaching. Color change was evaluated objectively and subjectively. Sensitivity evaluations were also accomplished. Seventy-six of the 78 subjects enrolled completed the study. All three products significantly lightened teeth. WW2 lightened more than WP2 and WW1 in L*, a*, b*, E and shade guide value. WP2 lightened more than WW1 in a*, b*, E and shade guide value. There was no difference in tooth sensitivity, but WW1 and WP2 caused less gingival sensitivity than WW2. The mean age of smokers was seven years younger than nonsmokers who qualified.

  1. Non-Clinical Safety Evaluation of Intranasal Iota-Carrageenan

    PubMed Central

    Hebar, Alexandra; Koller, Christiane; Seifert, Jan-Marcus; Chabicovsky, Monika; Bodenteich, Angelika; Bernkop-Schnürch, Andreas; Grassauer, Andreas; Prieschl-Grassauer, Eva

    2015-01-01

    Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded) iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug’s action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application. PMID:25875737

  2. A Clinical Assessment Program to Evaluate the Safety of Patient Care

    DTIC Science & Technology

    2005-01-01

    control number. 1. REPORT DATE 2005 2 . REPORT TYPE N/A 3. DATES COVERED - 4. TITLE AND SUBTITLE A Clinical Assessment Program to Evaluate...years. Additionally, the percentages of diabetics receiving insulin are almost identical in the two studies. Table 2 displays glycemic control for a...complications in patients with type II diabetes . A UK prospective diabetes study. Lancet 1998 Sep 12; 352(9131):837–53. 15. Saydah S, Fradkin J, Cowie C

  3. Clinical Predictors of Diagnostic Testing Utility in the Initial Evaluation of Chronic Kidney Disease

    PubMed Central

    Mendu, Mallika L.; Lundquist, Andrew; Aizer, Ayal A.; Leaf, David E.; Robinson, Emily; Steele, David J.R.; Waikar, Sushrut S.

    2016-01-01

    Aim No evidence-based approach to the evaluation of CKD has been established. We sought to identify clinical criteria to guide a rational diagnostic approach for the initial evaluation of CKD. Methods We conducted a retrospective cohort study of 1,487 patients presenting for initial evaluation of CKD over three years (1/2010–1/2013) to academic nephrology clinics. We utilized the electronic medical record to determine tests ordered, abnormal results, and testing that affected diagnosis and/or management. Diagnostic and management yield of testing was defined as the percentage of tests that affected diagnosis and/or management. High yield for a given test was defined as an increased likelihood of the test affecting diagnosis and/or management. Results We identified clinical criteria predictive of high yield for paraprotein-related testing (one of the following: history of monoclonal disease, high risk of CKD progression, hypercalcemia or hemoglobin <10.6), and clinical criteria predictive of high yield for glomerulonephritis testing (one of the following: abnormal urine sediment, 3+ or greater hematuria or proteinuria >500mg/gm). A prior history of hydronephrosis and renal artery stenosis was predictive of high yield of abnormal renal ultrasound. Higher yield of testing was associated with higher risk progression categories for ANA, SPEP, urine sediment, calcium, PTH, hemoglobin, iron, and ferritin. We estimate that initial CKD evaluation costs range from $28 to $109 million/year in US-Medicare expenditure. Conclusion Numerous tests without significant clinical utility are obtained in initial CKD evaluation. Identifying criteria that can guide diagnostic testing may lead to a more informed and cost-effective approach to evaluation. PMID:26610178

  4. EVALUATION OF CLINICAL PERIODONTAL CONDITIONS IN SMOKERS AND NON-SMOKERS

    PubMed Central

    Luzzi, Lucinara Ignez Tavares; Greghi, Sebastião Luiz Aguiar; Passanezi, Euloir; Sant'ana, Adriana Campos Passanezi; Lauris, José Roberto Pereira; Cestari, Tânia Mary

    2007-01-01

    Given that tobacco smoking habit is a risk factor for periodontal diseases, the aim of this study was to compare clinical periodontal aspects between smokers and non-smokers. The clinical status were assessed in 55 patients, 29 smokers and 26 non-smokers, aged 30 to 50 years, with mean age of 40. The clinical parameters used were: probing depth (PD), plaque index (PI), gingival index (GI), clinical attachment level (CAL), gingival recession (GR) and gingival bleeding index (GBI) for arches (upper and lower) and teeth (anterior and posterior). Tooth loss was also evaluated in both groups. Multiple regression analysis showed: tendency of greater probing depth and clinical attachment level means for smokers; greater amount of plaque in smokers in all regions; greater gingival index means for non-smokers with clinical significance (p<0.05) in all regions. Although, without statistical significance, the analysis showed greater gingival bleeding index means almost always for non-smokers; similar gingival recession means in both groups and tendency of upper tooth loss in smokers and lower tooth loss in non-smokers. The findings of this study showed that clinical periodontal parameters may be different in smokers when compared to non-smokers and that masking of some periodontal signs can be a result of nicotine's vasoconstrictor effect. PMID:19089190

  5. [Depression and dementia: perspectives from clinical studies].

    PubMed

    Nozaki, Shoko; Yoshimura, Kimio; Mimura, Masaru

    2012-12-01

    In this review, we present an overview of clinical studies that addressed the relationship between depression and dementia or cognitive decline. Cross-sectional studies and meta-analyses have repeatedly shown an association between late-life depression (LLD) and dementia, particularly Alzheimer's disease (AD) and vascular dementia; however, the findings of cohort studies have been inconsistent. Furthermore, studies on the association between depression with a younger age of onset and dementia have yielded inconsistent results. Regarding cognitive decline associated with LLD, several studies have reported an association between LLD and mild cognitive impairment, suggesting that depression itself can cause persistent cognitive impairment. Other studies have compared the cognitive profile between LLD and depression with a younger age of onset, but their results have been inconclusive, especially regarding the association between memory impairment and the age of onset of depression. LLD is associated with vascular change and white matter degeneration of the brain, as shown by magnetic resonance imaging (MRI). Recently, several studies reported an association between gray matter change and LLD. Studies currently in progress employ functional brain imaging methods such as single-photon emission computed tomography, functional MRI, and positron emission tomography. Clinically, it is important to understand how subtypes of depression can be defined in terms of risk of developing dementia, and to devise effective treatments. One paper explored the possibility of detecting depression associated with AD by measuring the blood Aβ40/Aβ42 levels, and other studies have suggested that symptoms of apathy and loss of interest are associated with conversion of depression to AD. Unfortunately, current antidepressants may have limited efficacy on depression with dementia; therefore, further investigation for devising methods of predicting conversion of depression to dementia and

  6. [Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

    PubMed

    Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

    2011-10-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

  7. Ligand-targeted particulate nanomedicines undergoing clinical evaluation: current status.

    PubMed

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

    2013-10-01

    Since the introduction of Doxil® on the market nearly 20years ago, a number of nanomedicines have become part of treatment regimens in the clinic. With the exception of antibody-drug conjugates, these nanomedicines are all devoid of targeting ligands and rely solely on their physicochemical properties and the (patho)physiological processes in the body for their biodistribution and targeting capability. At the same time, many preclinical studies have reported on nanomedicines exposing targeting ligands, or ligand-targeted nanomedicines, yet none of these have been approved at this moment. In the present review, we provide a concise overview of 13 ligand-targeted particulate nanomedicines (ligand-targeted PNMs) that have progressed into clinical trials. The progress of each ligand-targeted PNM is discussed based on available (pre)clinical data. Main conclusions of these analyses are that (a) ligand-targeted PNMs have proven to be safe and efficacious in preclinical models; (b) the vast majority of ligand-targeted PNMs is generated for the treatment of cancer; (c) contribution of targeting ligands to the PNM efficacy is not unambiguously proven; and (d) targeting ligands do not cause localization of the PNM within the target tissue, but rather provide benefits in terms of target cell internalization and target tissue retention once the PNM has arrived at the target site. Increased understanding of the in vivo fate and interactions of the ligand-targeted PNMs with proteins and cells in the human body is mandatory to rationally advance the clinical translation of ligand-targeted PNMs. Future perspectives for ligand-targeted PNM approaches include the delivery of drugs that are unable or inefficient in passing cellular membranes, treatment of drug resistant tumors, targeting of the tumor blood supply, the generation of targeted vaccines and nanomedicines that are able to cross the blood-brain barrier.

  8. The Clinical, Radiographic and Histological evaluation of three different concentrations of Formocresol as a pulpotomy agent

    PubMed Central

    Goyal, Swati; Abuwala, Tasnima; Joshi, Keyur; Mehta, Jahnvi; Indushekar, K R; Hallikerimath, Seema

    2014-01-01

    Background: Formocresol, though the center of much controversy is still the most widely used medicament for primary teeth pulpotomy and an intracanal medicament which has undergone a lengthy evolution to shorten the formocresol application time and reduce the concentration of formocresol exposure to the pulp tissue. Hence, the determination of the actual effective dose and concentration of formocresol for clinical application in primary teeth is an important area of research and a thorough clinical, radiographic and histological investigation in human subjects is very much needed. Materials & Methods: The study was conducted on 45 primary molars for the Clinical, Radiographic study and 45 premolars orthodontically indicated for extraction for the Histological study. The samples were randomly and equally divided into 3 groups of 15 each for pulpotomy with full strength formocresol, 1:5 diluted formocresol and 1:25 diluted formocresol respectively. The pulpotomized primary molars were clinically evaluated at 1st, 3rd, 6th and 9th month while the pulpotomized premolars were subjected for histological evaluation after extraction. Results: Obtained by chi-square test revealed that all the pulpotomized primary molars were asymptomatic till the end of the study period; suggesting 100% clinical and radiographic success while histologically, the three concentrations of formocresol showed decreased severity of fixation of the pulp tissue with decreasing concentration of formocresol. Conclusion: It can be inferred that the diluted formulations (1:5 and 1:25) of formocresol are equally efficient when compared to full-strength formocresol and thus, can be recommended for pulpotomy in primary teeth. How to cite the article: Goyal S, Abuwala T, Joshi K, Mehta J, Indushekar KR, Hallikerimath S. The Clinical, Radiographic and Histological evaluation of three different concentrations of Formocresol as a pulpotomy agent. J Int Oral Health 2014;6(2):118-25. PMID:24876712

  9. Evaluation of undergraduate nursing students' clinical confidence following a mental health recovery camp.

    PubMed

    Cowley, Thomas; Sumskis, Sue; Moxham, Lorna; Taylor, Ellie; Brighton, Renee; Patterson, Chris; Halcomb, Elizabeth

    2016-02-01

    In the present study, we evaluate the impact of participation in a mental health recovery camp on the clinical confidence of undergraduate nursing students in dealing with individuals with mental illness. Twenty undergraduate nursing students who participated in the recovery camp completed the Mental Health Nursing Clinical Confidence Scale both before and directly after attending the camp. Data were analysed using descriptive and inferential statistics. Participation in the recovery camp was associated with a statistically-significant increase in students' level of overall confidence between the pretest and post-test data (P < 0.005). The results also demonstrated that students over the age of 25 years and who do not have a family history of mental illness are more likely to self-report a higher level of confidence in both the pre- and post-results. The clinical confidence of undergraduate nursing students improved through participation in an immersive clinical experience within the recovery camp.

  10. Institutional ethics review of clinical study agreements.

    PubMed

    DuVal, G

    2004-02-01

    Clinical Study Agreements (CSAs) can have profound effects both on the protection of human subjects and on the independence of investigators to conduct research with scientific integrity. Sponsors, institutions, and even investigators may fail to give adequate attention to these issues in the negotiation of CSAs. Despite the key role of CSAs in structuring ethically important aspects of research, they remain largely unregulated and unreviewed for adherence to ethical norms. Academic institutions routinely enter into research contracts that fail to meet adequate ethical standards. This is a failing that can have serious consequences. Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review.

  11. The Alpha Stem Cell Clinic: A Model for Evaluating and Delivering Stem Cell-Based Therapies

    PubMed Central

    DeWitt, Natalie D.; Feigal, Ellen G.

    2012-01-01

    Summary Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies. PMID:23197634

  12. A comparative evaluation of the effectiveness of guided tissue regeneration by using a collagen membrane with or without decalcified freeze-dried bone allograft in the treatment of infrabony defects: A clinical and radiographic study

    PubMed Central

    Kher, Vishal Kiran; Bhongade, Manohar L.; Shori, Tony D.; Kolte, Abhay P.; Dharamthok, Swarup B.; Shrirao, Tushar S.

    2013-01-01

    Background: The present, randomized, controlled clinical and radiographic study was undertaken to compare the effectiveness of guided tissue regeneration (GTR) by using a collagen membrane barrier with or without decalcified freeze-dried bone allograft (DFDBA) in the treatment of periodontal infrabony defects characterized by unfavorable architecture. Materials and Methods: Sixteen systemically healthy patients with 20 periodontal infrabony defects were selected for the study. Each patient had at least ≥ 5 mm clinical probing pocket depth (PPD) at the selected site and depth of intrabony component ≥ 3 mm as assessed by clinical and radiographic measurements. Baseline measurements included plaque index, papillary bleeding index, PPD, gingival recession, clinical attachment level and radiographic defect depth (DD). At the time of surgery, the defects were randomly assigned to either the test group (collagen membrane plus DFDBA) or the control group (collagen membrane only). Results: At the 6-month examination, PPPD reduction was significantly greater in the GTR + DFDBA group (4.06 ± 0.38 mm) compared with the GTR group (3.2 ± 0.74 mm). The mean gains of clinical attachment were 3.54 ± 0.36 mm in the test group and 2.50 ± 0.74 mm in the control group. Radiographic DD reduction was similarly greater in the GTR + DFDBA group (2.40 ± 0.51 mm) compared with the GTR group (1.60 ± 0.51 mm). Conclusions: The results of the present study indicate that the use of a GTR membrane with bone graft has significantly improved all clinical parameters tested as compared with the use of bioresorbable membrane alone in the treatment of infrabony defects characterized by unfavorable architecture. PMID:24174729

  13. Omega-3 fatty acids and inflammation: a perspective on the challenges of evaluating efficacy in clinical research.

    PubMed

    Skulas-Ray, Ann C

    2015-01-01

    Chronic inflammation is a common underpinning of many diseases. There is a strong pre-clinical evidence base demonstrating the efficacy of omega-3 fatty acids for ameliorating inflammation and thereby reducing disease burden. Clinically, C-reactive protein (CRP) serves as both a reliable marker for monitoring inflammation and a modifiable endpoint for studies of anti-inflammatory pharmaceuticals. However, clinical omega-3 fatty acid supplementation trials have not replicated pre-clinical findings in terms of consistent CRP reductions. Methodological differences present numerous challenges in translating pre-clinical evidence to clinical results. It is crucial that future clinical nutrition research clearly distinguish between the reversal of established inflammation and preventing the development of inflammation. Future clinical studies evaluating the ability of omega-3 fatty acids to attenuate an excessive inflammatory response, may be advanced by employing new statistical approaches and utilizing models of induced inflammation, such as low-dose human endotoxemia.

  14. Portfolio as a tool to evaluate clinical competences of traumatology in medical students

    PubMed Central

    Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

    2016-01-01

    This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students’ portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching. PMID:26929675

  15. Portfolio as a tool to evaluate clinical competences of traumatology in medical students.

    PubMed

    Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

    2016-01-01

    This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students' portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching.

  16. Clinical validity of the counseling center assessment of psychological symptoms-62 (CCAPS-62): further evaluation and clinical applications.

    PubMed

    McAleavey, Andrew A; Nordberg, Samuel S; Hayes, Jeffrey A; Castonguay, Louis G; Locke, Benjamin D; Lockard, Allison J

    2012-10-01

    Self-report instruments of psychological symptoms are increasingly used in counseling centers but rely on rigorous evaluation of their clinical validity. Three studies reported here (total N = 26,886) investigated the validity of the Counseling Center Assessment of Psychological Symptoms-62 (CCAPS-62; Locke et al., 2011) as an assessment and screening instrument. In Study 1, initial evidence regarding the concurrent validity of the CCAPS-62 was replicated and extended in a naturalistic clinical sample of clients from 16 counseling centers. Using this sample, convergent validity of the subscales was examined in counseling center clients, the range of sensitivity of the subscales was investigated using item-response theory, and the presence of 2nd-order factors was preliminarily examined. In Study 2, 7 of the 8 CCAPS-62 subscales statistically significantly differentiated between students in counseling and those who were not, using data collected from a large national survey, although most differences were small and the groups' distributions overlapped considerably. Cut scores based on the differences between these clinical and nonclinical populations showed limited utility due to overall similarities between these broadly defined groups. In Study 3, therapist-rated diagnoses collected from 5 university counseling centers were used to further examine the validity of subscale scores. In addition, cut points for diagnostic screening using receiver operating characteristic curves were evaluated. Overall, these studies support the use of the CCAPS-62 as an initial measure of psychological symptoms in college counseling settings, provide additional information about its psychometric performance, develop cut scores, and illustrate the potential for collaboration between practitioners and researchers on a large scale.

  17. Clinical and radiological evaluation of inverse impaction of supernumerary teeth

    PubMed Central

    Kurklu, Esma; Gencay, Koray; Ak, Gulsum

    2013-01-01

    Objective: To describe the clinical and radiological features of children with inverted supernumerary teeth. Study Design: Thirty eight patients with inverted supernumerary teeth (ST) were enrolled in this descriptive and restrospective study. Data from patient records including age, gender, status of dentition, number of ST, number of ST in inverted position, coexistence of ST in inverted and normal direction of eruption, location, orientation, morphology, clinical complications, management and radiography were assessed during 3-years period. Results: Thirty eight patients with a mean age of 9.10±1.97 years (range:6-13) and a strong male preponderance of 3.7:1 (male:30, female:8) had a total of 69 ST, of which 41 were in inverted position. Thirty five patients had one (92.1%) inverted tooth, whereas 3 patients had two inverted teeth per case (7.9%). All cases were located in the maxilla. Midline was the most frequent site for the single inverted supernumerary tooth in 18 (47.4%) patients, followed equally by the right and left premaxillary region in 10 patients each (26.3%). Regarding morphology, 30 patients had conical (78.9%) and 8 (21.1%) had incisiform ST. No tuberculate shaped ST was detected. There was no statistically significant difference between number of inverted teeth and delayed tooth eruption, diastema, local malocclusion, palatinal swelling (p>0.05). There was no statistically significant difference between complications and age (p>0.05). Surgical removal at the time of diagnosis with subsequent follow-up during completion of permanent dentition was the treatment approach in all cases. Conclusions: Thorough clinical examination followed by a comprehensive radiographic screening is the crucial determinant of an accurate diagnosis of an impacted ST. Early diagnosis and timely management are key factors to prevent or minimize the complications, which may influence function and esthetics of the teeth and even psychological condition of the growing

  18. Clinical uses of melatonin: evaluation of human trials.

    PubMed

    Sánchez-Barceló, E J; Mediavilla, M D; Tan, D X; Reiter, R J

    2010-01-01

    During the last 20 years, numerous clinical trials have examined the therapeutic usefulness of melatonin in different fields of medicine. The objective of this article is to review, in depth, the science regarding clinical trials performed to date. The efficacy of melatonin has been assessed as a treatment of ocular diseases, blood diseases, gastrointestinal tract diseases, cardiovascular diseases, diabetes, rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, infectious diseases, neurological diseases, sleep disturbances, aging and depression. Melatonin has been also used as a complementary treatment in anaesthesia, hemodialysis, in vitro fertilization and neonatal care. The conclusion of the current review is that the use of melatonin as an adjuvant therapy seems to be well funded for macular degeneration, glaucoma, protection of the gastric mucosa, irritable bowel syndrome, arterial hypertension, diabetes, side effects of chemotherapy and radiation in cancer patients or hemodialysis in patients with renal insufficiency and, especially, for sleep disorders of circadian etiology (jet lag, delayed sleep phase syndrome, sleep deterioration associated with aging, etc.) as well as in those related with neurological degenerative diseases (Alzheimer, etc.,) or Smith-Magenis syndrome. The utility of melatonin in anesthetic procedures has been also confirmed. More clinical studies are required to clarify whether, as the preliminary data suggest, melatonin is useful for treatment of fibromyalgia, chronic fatigue syndrome, infectious diseases, neoplasias or neonatal care. Preliminary data regarding the utility of melatonin in the treatment of ulcerative colitis, Crohn's disease, rheumatoid arthritis are either ambiguous or negative. Although in a few cases melatonin seems to aggravate some conditions, the vast majority of studies document the very low toxicity of melatonin over a wide range of doses.

  19. Cost of clinical events in health economic evaluations in Germany: a systematic review.

    PubMed

    Scheuringer, Monika; Sahakyan, Narine; Krobot, Karl J; Ulrich, Volker

    2012-05-31

    Guidance from the Institute for Quality and Efficiency in Health Care (IQWiG) on cost estimation in cost-benefit assessments in Germany acknowledges the need for standardization of costing methodology. The objective of this review was to assess current methods for deriving clinical event costs in German economic evaluations. A systematic literature search of 24 databases (including MEDLINE, BIOSIS, the Cochrane Library and Embase) identified articles, published between January 2005 and October 2009, which reported cost-effectiveness or cost-utility analyses. Studies assessed German patients and evaluated at least one of 11 predefined clinical events relevant to patients with diabetes mellitus. A total of 21 articles, describing 199 clinical cost events, met the inclusion criteria. Year of costing and time horizon were available for 194 (97%) and 163 (82%) cost events, respectively. Cost components were rarely specified (32 [16%]). Costs were generally based on a single literature source (140 [70%]); where multiple sources were cited (32 [16%]), data synthesis methodology was not reported. Cost ranges for common events, assessed using a Markov model with a cycle length of 12 months, were: acute myocardial infarction (nine studies), first year, 4,618-17,556 €; follow-up years, 1,006-3,647 €; and stroke (10 studies), first year; 10,149-24,936 €; follow-up years, 676-7,337 €. These results demonstrate that costs for individual clinical events vary substantially in German health economic evaluations, and that there is a lack of transparency and consistency in the methods used to derive them. The validity and comparability of economic evaluations would be improved by guidance on standardizing costing methodology for individual clinical events.

  20. Cost of clinical events in health economic evaluations in Germany: a systematic review

    PubMed Central

    2012-01-01

    Guidance from the Institute for Quality and Efficiency in Health Care (IQWiG) on cost estimation in cost–benefit assessments in Germany acknowledges the need for standardization of costing methodology. The objective of this review was to assess current methods for deriving clinical event costs in German economic evaluations. A systematic literature search of 24 databases (including MEDLINE, BIOSIS, the Cochrane Library and Embase) identified articles, published between January 2005 and October 2009, which reported cost-effectiveness or cost-utility analyses. Studies assessed German patients and evaluated at least one of 11 predefined clinical events relevant to patients with diabetes mellitus. A total of 21 articles, describing 199 clinical cost events, met the inclusion criteria. Year of costing and time horizon were available for 194 (97%) and 163 (82%) cost events, respectively. Cost components were rarely specified (32 [16%]). Costs were generally based on a single literature source (140 [70%]); where multiple sources were cited (32 [16%]), data synthesis methodology was not reported. Cost ranges for common events, assessed using a Markov model with a cycle length of 12 months, were: acute myocardial infarction (nine studies), first year, 4,618–17,556 €; follow-up years, 1,006–3,647 €; and stroke (10 studies), first year; 10,149–24,936 €; follow-up years, 676–7,337 €. These results demonstrate that costs for individual clinical events vary substantially in German health economic evaluations, and that there is a lack of transparency and consistency in the methods used to derive them. The validity and comparability of economic evaluations would be improved by guidance on standardizing costing methodology for individual clinical events. PMID:22651885

  1. A clinical advancement process revisited: a descriptive study.

    PubMed

    Ward, Cynthia W; Goodrich, Cynthia A

    2007-06-01

    Clinical advancement programs are not evaluated often for effectiveness and participant satisfaction. The advancement committee at this community hospital made the commitment to evaluate participant satisfaction periodically. Revisions were made in the program based on the evaluation findings and implemented in 2002. This re-evaluation was conducted to determine participant satisfaction.

  2. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  3. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  4. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  5. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

  6. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study

    PubMed Central

    Bhowmick, Subhrojyoti; Banerjee, Koyel; Sikdar, Shreya; Chatterjee, Tapan Kumar

    2014-01-01

    Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance

  7. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials.

    PubMed

    Lantos, John D; Wendler, David; Septimus, Edward; Wahba, Sarita; Madigan, Rosemary; Bliss, Geraldine

    2015-10-01

    Institutional review boards, which are charged with overseeing research, must classify the riskiness of proposed research according to a federal regulation known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration codified in 21 CFR 50. If an institutional review board determines that a clinical trial constitutes "minimal risk," there are important practical implications: the institutional review board may then allow a waiver or alteration of the informed consent process; the study may be carried out in certain vulnerable populations; or the study may be reviewed by institutional review boards using an expedited process. However, it is unclear how institutional review boards should assess the risk levels of pragmatic clinical trials. Such trials typically compare existing, widely used medical therapies or interventions in the setting of routine clinical practice. Some of the therapies may be considered risky of themselves but the study comparing them may or may not add to that pre-existing level of risk. In this article, we examine the common interpretations of research regulations regarding minimal-risk classifications and suggest that they are marked by a high degree of variability and confusion, which in turn may ultimately harm patients by delaying or hindering potentially beneficial research. We advocate for a clear differentiation between the risks associated with a given therapy and the incremental risk incurred during research evaluating those therapies as a basic principle for evaluating the risk of a pragmatic clinical trial. We then examine two pragmatic clinical trials and consider how various factors including clinical equipoise, practice variation, research methods such as cluster randomization, and patients' perspectives may contribute to current and evolving concepts of minimal-risk determinations, and how this understanding in turn affects the design and conduct of pragmatic clinical trials.

  8. Clinical evaluation of deslorelin to induce oestrus, ovulation and pregnancy in the bitch.

    PubMed

    von Heimendahl, A; Miller, C

    2012-12-01

    The aim of this study was to evaluate the practical use of Deslorelin in a clinical setting to induce oestrus and ovulation and to assess pregnancy rates. Sixteen anoestrus bitches that were brought into the clinic were implanted subcutaneously in the ventral abdomen with Deslorelin. Implants were removed after ovulation was assumed to have occurred. All bitches came into oestrus and 13 ovulated. 11 of 16 bitches became pregnant (68.8%) and all continued to term. Average litter size was 7.6 puppies. On average, the implant was in place for 13.8 days.

  9. Portfolio assessment and evaluation: implications and guidelines for clinical nursing education.

    PubMed

    Chabeli, M M

    2002-08-01

    With the advent of Outcomes-Based Education in South Africa, the quality of nursing education is debatable, especially with regard to the assessment and evaluation of clinical nursing education, which is complex and renders the validity and reliability of the methods used questionable. This paper seeks to explore and describe the use of portfolio assessment and evaluation, its implications and guidelines for its effective use in nursing education. Firstly, the concepts of assessment, evaluation, portfolio and alternative methods of evaluation are defined. Secondly, a comparison of the characteristics of the old (traditional) methods and the new alternative methods of evaluation is made. Thirdly, through deductive analysis, synthesis and inference, implications and guidelines for the effective use of portfolio assessment and evaluation are described. In view of the qualitative, descriptive and exploratory nature of the study, a focus group interview with twenty students following a post-basic degree at a university in Gauteng regarding their perceptions on the use of portfolio assessment and evaluation method in clinical nursing education was used. A descriptive method of qualitative data analysis of open coding in accordance with Tesch's protocol (in Creswell 1994:155) was used. Resultant implications and guidelines were conceptualised and described within the existing theoretical framework. Principles of trustworthiness were maintained as described by (Lincoln & Guba 1985:290-327). Ethical considerations were in accordance with DENOSA's standards of research (1998:7).

  10. Angular cheilitis: a clinical and microbial study.

    PubMed

    Ohman, S C; Dahlén, G; Möller, A; Ohman, A

    1986-04-01

    The purpose of this prospective study was to re-examine the relative importance of various factors in the pathogenesis of angular cheilitis. Sixty-four patients with cheilitis were examined clinically and microbiologically. In addition, a subsample of 23 patients was examined for serum iron and transferrin. The clinical appearance of the lip lesions fell into 4 categories. A ground rhagad at the corner of the mouth involving adjacent skin, was the most frequent type among dentate patients, whereas among denture wearers a deep lesion following the labial marginal sulcus was frequently observed. Dentate patients and denture wearers with cheilitis often had atopic constitution or cutaneous diseases. Pathogenic microorganisms were cultured from the lesions in all 64 patients; Staphylococcus aureus in 40 patients and Candida albicans in 45. The results of this study indicate a correlation between angular cheilitis and pathogenic microorganisms. Furthermore, among dentate patients, a correlation exists between cutaneous discomfort and angular cheilitis. Other etiological factors suggested for this disorder were found to be of subordinate importance.

  11. Clinical evaluation of 30 patients with localized nasal rosacea.

    PubMed

    Lee, Woo Jin; Lee, Ye Jin; Won, Chong Hyun; Chang, Sung Eun; Choi, Jee Ho; Lee, Mi Woo

    2016-02-01

    The clinical features of localized nasal rosacea have not been described in detail. This study was designed to analyze the subtypes and severity of localized nasal rosacea. Our present study included 30 patients with localized nasal rosacea. The erythematotelangiectatic subtype (13/30, 43.3%) was the most common type, followed by the phymatous subtype (9/30, 30%). The duration of rosacea was shorter and the severity of localized nasal rosacea was lower in the erythematotelangiectatic subtype cases compared with the patients with mixed or phymatous subtypes. Almost all of the papulopustular eruptions or phymatous lesions were associated with erythematotelangiectatic lesions. These findings suggest that the erythematotelangiectatic subtype may be considered the initial phase of localized nasal rosacea.

  12. [Evaluation of the clinical practice of Informed Consent in clinical trials].

    PubMed

    Gost, J; Silvestre, C; Ezpeleta, P; Astier, P; Díaz de Rada, O; Artázcoz, M T

    2003-01-01

    On the basis of existing publications it would seem legitimate to assume that in a clinical test (CT) the difficulties inherent in the process of researcher-participant communication are in practice greater than desired. Similarly, the hypothesis is adopted that difficulties exist in the formal legibility of the documents of Informed Consent. We present the results of a transversal study made of a random sample (n=160) of the CTs approved by the Ethical Committee of Clinical Research (CEIC) of Navarra during the years 1995-1999. The results found were: in 69.7% of the cases the researcher filed the documents corresponding to the CT, the Informed Consent appears signed by the researcher in 56.6% of the CTs, and in more than 83% of the cases the written information shows shortcomings in legibility, which confirms the correctness of the hypothesis and permits the detection of areas where improvements need to be developed.

  13. A prospective 9-month human clinical evaluation of Laser-Assisted New Attachment Procedure (LANAP) therapy.

    PubMed

    Nevins, Marc; Kim, Soo-Woo; Camelo, Marcelo; Martin, Ignacio Sanz; Kim, David; Nevins, Myron

    2014-01-01

    This investigation was designed and implemented as a single-center, prospective study to evaluate the clinical response to the Laser-Assisted New Attachment Procedure (LANAP). Eight patients with advanced periodontitis were enrolled and treated with full-mouth LANAP therapy and monitored for 9 months. Fullmouth clinical measurements, including clinical attachment level (CAL), probing depth (PD), and recession, were provided at baseline and after 9 months of healing by a single calibrated examiner, including a total of 930 sites and 444 sites with initial PD equal to or greater than 5 mm. Clinical results for the 930 sites measured pre- and postoperatively revealed that mean PD was reduced from 4.62 ± 2.29 mm to 3.14 ± 1.48 mm after 9 months (P < .05). CAL decreased from 5.58 ± 2.76 mm to 4.66 ± 2.10 mm (P < .05) and recession increased from 0.86 ± 1.31 mm to 1.52 ± 1.62 after 9 months (P < .05). For the subset of 444 sites with initial PD greater than or equal to 5 mm, the PD decreased from 6.50 ± 2.07 mm to 3.92 ± 1.54 mm (P < .05) and CAL decreased from 7.42 ± 2.70 mm to 5.78 ± 2.06 mm (P < .05). As demonstrated by the clinical evaluation, the majority of treated sites demonstrated clinical improvement. LANAP therapy should be further investigated with long-term clinical trials to compare the stability of clinical results with conventional therapy.

  14. The World Hip Trauma Evaluation Study 3

    PubMed Central

    Parsons, N.; Achten, J.; Griffin, X. L.; Costa, M. L.; Reed, M. R.

    2016-01-01

    Background Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes. Design This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset. Discussion Evidence on the optimum choice of prosthesis for hemiarthroplasty of the hip is lacking. National guidance is currently based on expert opinion rather than empirical evidence. The incidence of hip fracture is likely to continue to increase and providing high quality evidence on the optimum Cite this article: A. L. Sims. The World Hip Trauma Evaluation Study 3: Hemiarthroplasty Evaluation by Multicentre Investigation – WHITE 3: HEMI – An Abridged Protocol. Bone Joint Res 2016;5:18–25. DOI: 10.1302/2046-3758.51.2000473 PMID:26825319

  15. Total hydrocarbon analyzer evaluation study

    SciTech Connect

    Shamat, N. ); Crumpler, E. ); Roddan, A. )

    1991-10-01

    Measuring and controlling organic emissions from incineration processes has become a major environmental concern in recent years. The US Environmental Protection Agency (EPA) recently proposed a regulation for sewage sludge incinerators under section 405(d) of the Clean Water Act that will require all sludge incinerators to monitor total hydrocarbon emissions (THCs) on a continuous basis. Such a requirement would be part of National Pollutant Discharge Elimination (NPDES) permits and site-specific THC limits would be established for facilities based on a risk assessment of organic emissions. Before EPA can finalize the proposed requirement, THC monitoring must be successfully conducted in a plant environment and the system required by any final regulation must be kept in operation so that facilities can comply with their permits. The Metropolitan Waste Control Commission (MWCC) in St. Paul, Minn., and Rosemount Analytical Division in La Habre, Calif., entered into a joint agreement with EPA to demonstrate a hot' THC monitoring system to detect THCs in stack gases. The objectives of the study are to determine the feasibility of THC monitoring of sludge incinerator emissions; evaluate the long term reliability, cost of operation, and consistency of a continuous THC monitoring system in an incinerator environment; and determine the correlation of THC stack concentration to incinerator and scrubber operating conditions, carbon monoxide concentration, and specific VOC emissions.

  16. Evaluation -- Shanti: A Case Study.

    ERIC Educational Resources Information Center

    Rosen, David J.; Mulcahy, Gene

    1975-01-01

    This newsletter comprises four sections: (1) the educational philosophy and objectives of Shanti, a public alternative school in Hartford, Connecticut; (2) Rosen's statements about the difficulties of finding an evaluation model for alternative schools and the implications of the methodology that he later used in evaluating the Shanti school in…

  17. Smarter candidate selection--utilizing microdosing in exploratory clinical studies.

    PubMed

    Buchan, P

    2007-01-01

    Microdosing offers a faster and potentially less expensive approach to obtaining human in vivo PK data in early clinical drug development. It encompasses the use of pharmacologically inactive doses of test drug in the low microgram range along with ultrasensitive assay methods (PET, AMS) to assess human exposure in order to extrapolate the PK of higher, clinically more relevant doses, assuming linear PK. This strategy allows early evaluation of systemic clearance, oral bioavailability as well as sources of intersubject variability and questions of specific metabolite formation. It does take advantage of reduced regulatory requirements of preclinical safety studies, bulk drug synthesis (CMC requirements) and easier formulation options, e.g., as part of an exploratory IND; however, this is counterbalanced by a need to synthesize radiolabeled test compound and the development of a sophisticated analytical method. Ongoing studies will determine the predictability of human PK using Microdosing methods.

  18. Repurposing metformin for cancer treatment: current clinical studies

    PubMed Central

    Chae, Young Kwang; Arya, Ayush; Malecek, Mary-Kate; Shin, Daniel Sanghoon; Carneiro, Benedito; Chandra, Sunandana; Kaplan, Jason; Kalyan, Aparna; Altman, Jessica K.; Platanias, Leonidas; Giles, Francis

    2016-01-01

    In recent years, several studies have presented evidence suggesting a potential role for metformin in anti-cancer therapy. Preclinical studies have demonstrated several anticancer molecular mechanisms of metformin including mTOR inhibition, cytotoxic effects, and immunomodulation. Epidemiologic data have demonstrated decreased cancer incidence and mortality in patients taking metformin. Several clinical trials, focused on evaluation of metformin as an anti-cancer agent are presently underway. Data published from a small number of completed trials has put forth intriguing results. Clinical trials in pre-surgical endometrial cancer patients exhibited a significant decrease in Ki67 with metformin monotherapy. Another interesting observation was made in patients with breast cancer, wherein a trend towards improvement in cancer proliferation markers was noted in patients without insulin resistance. Data on survival outcomes with the use of metformin as an anti-cancer agent is awaited. This manuscript will critically review the role of metformin as a potential cancer treatment. PMID:27004404

  19. Axon clinical chemistry analyzer evaluated according to ECCLS protocol.

    PubMed

    Brenna, S; Prencipe, L

    1992-10-01

    We assessed the analytical performance of the Axon system (Bayer Diagnostici), according to the European Committee for Clinical Laboratory Standards guidelines, for assay of 12 analytes: cholesterol, creatinine, glucose, total protein, urea, uric acid, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine kinase, sodium, and potassium. The field evaluation lasted approximately 5 months and involved the collection of approximately 10,000 data points with the Axon. The following results were obtained: The highest CVs for controls and human sera at different concentration/activity values were 2.2% for within-run imprecision (n = 60; 3 days, pooled estimate) and 3.5% for the between-day imprecision (n = 20 days). Close correlation was found with results for patients' specimens assayed with comparative instruments (Hitachi 717 for substrates and enzymes, Beckman Synchron EL/E4A for electrolytes). No drift was observed during 8 h of operation. The linearity range was broad, sometimes exceeding the manufacturer's claims. No sample-, reagent-, or cuvette-related carryover was found. Measurement of control sera gave results within +/- 5% of the assigned values. We conclude that good reliability and practicability make the Axon system suitable for laboratories with various needs.

  20. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    PubMed

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinic