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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. 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…

  3. 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...

  4. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... 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... the Clinical Science Research and Development Service on the relevance and feasibility of...

  5. 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...

  6. 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...

  7. 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...

  8. How to evaluate study methodology in published clinical research.

    PubMed

    Stoddard, G J; Ring, W H

    1993-01-01

    When reading a clinical research article, the clinician must judge if the reported findings and conclusions are valid before applying them to patient care. This concern is legitimate given the wide range of study validity in the clinical literature. In this article, the authors present many validity markers that signify the quality of the information reported from a study, such as authorship, bias, confounding, statistics, randomization, controls, blinding, and the logical framework of scientific investigations. PMID:8478779

  9. 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

  10. 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...

  11. A descriptive study of a clinical evaluation tool and process: student and faculty perspectives.

    PubMed

    Krautscheid, Lorretta; Moceri, Joane; Stragnell, Susan; Manthey, Lisa; Neal, Thea

    2014-03-01

    Clinical evaluation tools are designed to assess nursing students' knowledge, skills, and attitudes related to program and course outcomes and professional nursing standards. Students, faculty, administrators, and the public rely on the effectiveness of the tool and process to determine progression within the curriculum and validate competency. In May 2012, a revised clinical evaluation tool was implemented in a baccalaureate nursing program. This study was undertaken to evaluate the revised clinical evaluation tool by exploring the perspectives of students and faculty who use the tool and engage in the evaluation process. Findings revealed the tool was user friendly and instructions were clear, with sufficient grading criteria to determine clinical competency. Findings also revealed areas for improvement in the evaluation process, including orientation to the tool, connecting program outcomes to clinical performance, and meaningful participation in evaluation. Recommendations are made for improving the clinical evaluation process. PMID:24512331

  12. 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...

  13. 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...

  14. 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...

  15. 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...

  16. Problems and challenges of nursing students’ clinical evaluation: A qualitative study

    PubMed Central

    Rafiee, Ghazanfar; Moattari, Marzieh; Nikbakht, Alireza N; Kojuri, Javad; Mousavinasab, Masoud

    2014-01-01

    Background: The purpose of this qualitative exploratory study was to explore the views of nursing trainers and students about nursing students’ clinical evaluation problems and drawbacks in Shiraz Nursing and Midwifery School. Materials and Methods: A qualitative exploratory approach was used in this study at Shiraz Nursing and Midwifery School in 2012. A purposeful sample of 8 nursing instructors and 40 nursing students was interviewed and the data on their opinions about the problems of the clinical evaluation were collected through semi-structured deep interviews. Initially, four open-ended questions, which were related to the clinical evaluation status, problems, were used to stimulate discussions in the interview sessions. Content analysis was employed in order to analyze the transcribed data. The recorded interviews were initially transcribed, read, and reread on a number of occasions to get an overall feeling of what the participants were saying. Each line or incident was described, and then a code, which reflected the essence of the participants’ comments, was given. Results: The codes were compared for similarity and differences, merged together, and categorized. Finally, five themes emerged: In appropriate clinical evaluation method, problems of clinical evaluation Process, problems related to clinical instructors, unsuitable programming of clinical education, and organizational shortcomings. Conclusion: Besides focusing on upgrading the current clinical evaluation forms, nursing trainers should improve their knowledge about a complete and comprehensive clinical evaluation. They should also apply other appropriate and objective clinical evaluation methods and tools, and perform a formative and summative clinical evaluation. Also, workload adjustment of the nursing trainers needs revision. Therefore, despite using traditional and sometimes limited evaluation methods for assessing nursing students, a co mprehensive and appropriate evaluation of nursing

  17. 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…

  18. 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

  19. 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.

  20. 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

  1. 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. PMID:26879687

  2. Development of the clinical learning evaluation questionnaire for undergraduate clinical education: factor structure, validity, and reliability study

    PubMed Central

    2014-01-01

    Background Teaching and learning of clinical skills for undergraduate medical students usually takes place during the clinical clerkship. Therefore, it is of vital importance to ensure the effectiveness of the rotations within this clerkship. The aims of this study were to develop an instrument that measures the effectiveness of the clinical learning environment, to determine its factor structure, and to find first evidence for the reliability and validity of the total scale and the different factors. Methods The Clinical Learning Evaluation Questionnaire (CLEQ) is an instrument, consisting of 40 items, which have been developed after consideration of the results of a qualitative study that investigated the important factors influencing clinical learning, both from the perspective of students, as well as teachers. Results of relevant literature that investigated this issue were also incorporated in the CLEQ. This instrument was administered to a sample of students (N = 182) from three medical colleges in Riyadh city, the capital of Saudi Arabia. The factor structure of the CLEQ (Principal component analysis, Oblimin rotation) and reliability of the factor scales (Cronbach’s α) were determined. Hypotheses concerning the correlations between the different factors were tested to investigate their convergent and divergent validity. Results One hundred and nine questionnaires were returned. The factor analysis yielded six factors: F1 Cases (8 items), F2 Authenticity of clinical experience (8 items), F3 Supervision (8 items), F4 Organization of the doctor-patient encounter (4 items), F5 Motivation to learn (5 items), and F6 Self awareness (4 items). The overall internal consistency (α) of the CLEQ was 0.88, and the reliabilities (Cronbach’s α) of the six factors varied from .60 to .86. Hypotheses concerning the correlations between the different factors were partly confirmed, which supported the convergent validity of the factors, but not their divergent

  3. 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…

  4. Outpatient preanaesthesia evaluation clinics.

    PubMed

    Lew, E; Pavlin, D J; Amundsen, L

    2004-11-01

    In recent years, there has been a paradigm shift from an inpatient to outpatient preanaesthesia evaluation. This has been driven by rising healthcare costs and the increasing popularity of ambulatory and same-day admission surgery. These outpatient preanaesthesia clinics play an important role in enhancing the cost-effectiveness of the perioperative process. This review describes the structure of modern outpatient preanaesthesia evaluation clinics, and the associated benefits, limitations and controversies. PMID:15510321

  5. The 15-item Systemic Clinical Outcome and Routine Evaluation (SCORE-15) Scale: Portuguese Validation Studies.

    PubMed

    Vilaça, Margarida; de Sousa, Bruno; Stratton, Peter; Relvas, Ana Paula

    2015-01-01

    This study reports on the validity of the 15-item Portuguese version of the Systemic Clinical Outcome Routine Evaluation (SCORE-15; Vilaça, Silva, & Relvas, 2014), a brief and comprehensive measure of family functioning. Previous studies with SCORE-15 show that this version replicates the three-factor solution found for the original English version: Family strengths, Family communication and Family difficulties. In addition to reviewing previous studies, this article analyses the discriminant, convergent and predictive validity of the Portuguese SCORE-15. To do so, the SCORE-15 was administered to family members attending systemic family or couple's therapy at the start of the first and fourth sessions and also to a group of non-clinical individuals. Overall, data are reported from 618 participants, including 136 from families attending systemic therapy and 482 community family members. Comparisons of community and clinical samples (discriminant validity) showed statistically significant differences for the total scale and subscales (p < .001), with the community participants presenting healthier family functioning than the clinical ones. Analyses using SCORE-15 and the Quality of Life - adult version, another family measure applied simultaneously (convergent validity), indicate that both scales are significantly (p < .01) and moderately (r = -.47) correlated. Mean score analysis of SCORE-15's therapeutic sensitivity to change (predictive validity) showed that only the Family communication subscale was sensitive to statistically significant improvement (p < .05) from session 1 to session 4, whereas the SCORE-15's reliability change index points to its ability to detect clinical improvements (RCI = 14%). PMID:26585316

  6. 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. PMID:26919617

  7. Clinical evaluation of direct composite restoration done for midline diastema closure – long-term study

    PubMed Central

    Prabhu, R.; Bhaskaran, S.; Geetha Prabhu, K. R.; Eswaran, M. A.; Phanikrishna, G.; Deepthi, B.

    2015-01-01

    Purpose of the Study: The aim of this study was to evaluate clinically the performance of composite resin used to restore midline diastema between the maxillary and mandibular central incisors. Methodology: Direct composite restorations were done for 45 patients with midline diastema between the maxillary and mandibular central incisors. Standard protocols were followed for the placement of composite resin for the diastema closure, and recall visits were made for every 6 months for a period of 60 months for evaluation of the success of these restorations made. Qualified dental personnel examined the restorations made. Results: Clinical evaluations were done after the restorations had been in place for an average of 6 months. Results indicate that none of the restorations were totally lost, and resulting in a 91% overall retention rate for the period of 60 months. About 62% of the restorations made had no noticeable color difference with that of the adjacent tooth, and gingival health indicated 73% of the sample was without any signs of inflammation. Conclusions: Composites restored for diastemas exhibit satisfactory survival rates placed with recommended placement protocols and without occlusal loading. PMID:26538917

  8. 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

  9. 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

  10. 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. PMID:27354708

  11. 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. PMID:26722858

  12. 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

  13. 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

  14. 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. PMID:26711142

  15. One-year clinical evaluation of a Glass Carbomer fissure sealant, a preliminary study.

    PubMed

    Gorseta, K; Glavina, D; Borzabadi-Farahani, A; Van Duinen, R N; Skrinjaric, I; Hill, R G; Lynch, E

    2014-06-01

    Glass Carbomer is a new generation of restorative material developed from glass-ionomer cements with possibility of gradual mineralization into fluorapatite. The aim of this clinical trial was to investigate the retention of Glass Carbomer fissure sealant after 12 months, in comparison to a commonly used conventional resin-based sealant. Forty-eight teeth in 24 patients [mean (SD) = 8 (2.3) years] with well-delineated fissure morphology were randomly divided into two equal groups and sealed with Bis-GMA resin-based Helioseal F (group A, Ivoclar Vivadent, Liechtenstein) and Glass Carbomer (group B, Glass Carbomer Sealant, Glass Carbomer Products, Leiden, Netherlands) using the split mouth design. Materials were placed and set according to the manufacturer's instructions using a polymerization unit Bluephase 16i (Vivadent, Liechtenstein). Complete sealant retentions in both groups were 100% and 75% after 6 and 12 months of clinical service, respectively. There were there were no secondary caries lesions in both groups after 6 months; two new carious lesions were detected in both groups after 12 months. The Mann-Whitney U test revealed no significant difference between the two groups at both evaluations points (P > 0.05). Glass Carbomer material showed a similar retention rate when compared with a resin-based sealant. Future studies are required to examine the long-term performance of Glass Carbomer sealants. PMID:25134364

  16. 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. PMID:3323274

  17. Evaluation of accuracy of cone beam computed tomography for measurement of periodontal defects: A clinical study

    PubMed Central

    Banodkar, Akshaya Bhupesh; Gaikwad, Rajesh Prabhakar; Gunjikar, Tanay Udayrao; Lobo, Tanya Arthur

    2015-01-01

    Aims: The aim of the present study was to evaluate the accuracy of Cone Beam Computed Tomography (CBCT) measurements of alveolar bone defects caused due to periodontal disease, by comparing it with actual surgical measurements which is the gold standard. Materials and Methods: Hundred periodontal bone defects in fifteen patients suffering from periodontitis and scheduled for flap surgery were included in the study. On the day of surgery prior to anesthesia, CBCT of the quadrant to be operated was taken. After reflection of the flap, clinical measurements of periodontal defect were made using a reamer and digital vernier caliper. The measurements taken during surgery were then compared to the measurements done with CBCT and subjected to statistical analysis using the Pearson's correlation test. Results: Overall there was a very high correlation of 0.988 between the surgical and CBCT measurements. In case of type of defects the correlation was higher in horizontal defects as compared to vertical defects. Conclusions: CBCT is highly accurate in measurement of periodontal defects and proves to be a very useful tool in periodontal diagnosis and treatment assessment. PMID:26229268

  18. 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

  19. 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. PMID:26362476

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

    PubMed Central

    Varadharaja, M.; Udhya, J.; Srinivasan, Ila; Sivakumar, Jambai Sampath Kumar; Karthik, Ramasamy Sundararajan; Manivanan, M.

    2014-01-01

    Aim: The aim of this study to evaluate the effectiveness of pain control by employing transcutaneous electrical nerve stimulator (TENS) over conventional injectable local anesthesia for children requiring restorative procedures under rubber dam. Materials and Methods: The study design considered was the split mouth design, in experiment (right) side, dental procedures under rubber dam was performed under TENS and in control (left) side, dental procedures under rubber dam was performed under conventional injectable local anesthetic (LA). The level of comfort and discomfort experienced during TENS and conventional LA was determined using visual analog scale (VAS) and heart rate. Result: Increase in mean heart rate associated with TENS (0.78%) was significantly less compared to increase in heart rate with administration of conventional local anesthesia (11.78%). In VAS, the mean values for pain indicate that minimum pain was felt with TENS, which was closely followed by LA. Conclusion: TENS can offer many safer and psychological advantages and is a valuable alternative to conventional LA for children. PMID:25210350

  1. Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia, Clinical Presentation and Diagnostic Evaluation: Results from the North American Multidisciplinary Study

    PubMed Central

    Marcus, Frank I; Zareba, Wojciech; Calkins, Hugh; Towbin, Jeffrey A; Basso, Cristina; Bluemke, David A; Estes, N. A. Mark; Picard, Michael H; Sanborn, Danita; Thiene, Gaetano; Wichter, Thomas; Cannom, David; Wilber, David J; Scheinman, Melvin; Duff, Henry; Daubert, James; Talajic, Mario; Krahn, Andrew; Sweeney, Michael; Garan, Hasan; Sakaguchi, Scott; Lerman, Bruce; Kerr, Charles; Kron, Jack; Steinberg, Jonathan; Sherrill, Duane; Gear, Kathleen; Brown, Mary; Severski, Patricia; Polonsky, Slava; McNitt, Scott

    2009-01-01

    Background Prior reports on patients with ARVC/D focused on individuals with advanced forms of the disease. There are limited data regarding diagnostic performance of various testing modalities in newly identified individuals suspected of having ARVC/D. Objectives The Multidisciplinary Study of Arrhythmogenic Right Ventricular Cardiomyopathy/Dysplasia (ARVC/D) was initiated to study the clinical characteristics and the diagnostic evaluation of a large group of newly identified patients with ARVC/D. Methods A total of 108 newly diagnosed patients with suspected ARVC/D were prospectively enrolled in the United States and Canada. The patients underwent noninvasive and invasive tests using standardized protocols that were initially interpreted by the enrolling center and adjudicated by blind analysis in six core laboratories. The patients were followed for a mean of 27 ± 16 months (0.2 – 63 months). Results The clinical profile of these newly diagnosed patients differs from those reported with more advanced disease. There was considerable difference in the initial and final classification of the presence of ARVC/D after the diagnostic tests were evaluated by the core laboratories. Final clinical diagnosis was 73 affected, 28 borderline, and 7 unaffected. Individual tests agreed with final diagnosis in 50% to 70% of the 73 who had final classification as affected. Conclusions The clinical profile of 108 newly diagnosed probands with suspected ARVC/D indicates that a combination of diagnostic tests is needed to evaluate the presence of right ventricular structural, functional and electrical abnormalities. Echocardiography, RV angiography, SAECG and Holter monitoring provide optimal clinical evaluation of patients suspected of ARVC/D. PMID:19560088

  2. Clinical neurological evaluation.

    PubMed

    Weiss, A H

    1995-06-01

    The importance of the neurological evaluation for PLDD procedures is discussed. Elements of the basic examination are outlined and the reason for specific methods of testing are offered. The physician should pay attention to patient complaints, mechanical signs, and patient capabilities. PMID:10150642

  3. Evaluating Nursing Students' Clinical Performance.

    PubMed

    Koharchik, Linda; Weideman, Yvonne L; Walters, Cynthia A; Hardy, Elaine

    2015-10-01

    This article is one in a series on the roles of adjunct clinical faculty and preceptors, who teach nursing students to apply knowledge in clinical settings. This article describes aspects of the student evaluation process, which should involve regular feedback and clearly stated performance expectations. PMID:26402292

  4. Evaluation of Palatal Plate Thickness of Maxillary Prosthesis on Phonation- A Comparative Clinical Study

    PubMed Central

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

    2014-01-01

    Background: Prosthodontic treatment involves clinical procedures which influence speech performance directly or indirectly. Prosthetic rehabilitation of missing teeth with partial or complete maxillary removable dentures influences the individual voice characteristics like Phonation, resonance etc. Aim: To evaluate the effect of Acrylic palatal plate thickness (1mm-3mm) of maxillary prosthesis on phonation. Materials and Methods: Twelve subjects were selected randomly between the age group of 20-25 years who have full complement of teeth and have no speech problems. Speech evaluation was done under four experimental conditions i.e. Without any experimental acrylic palatal plate (control), with experimental acrylic palatal plates of thickness 1 mm, 2 mm and 3 mm respectively. The speech material for phonation test consisted of Vowels sounds /a/, /i/, and /o/. Speech analysis to assess phonation was done using digital acoustic analysis (PRAAT software). The obtained results were statistically analyzed by One-way ANOVA and Tukey’s multiple post-hoc for comparison of four experimental conditions with respect to different vowel sounds. Results: Mean harmonics to noise ratio (HNR) values obtained for all the Experimental conditions did not show significant difference (p>0.05). In conclusion, an increase in the thickness of the acrylic palatal plate of maxillary prosthesis for about 1 mm - 3mm in complete or partial maxillary removable dentures resulted in no significant effect on phonation of vowel sounds /a/, /i/ and /o/. Conclusion: Increasing the thickness of the palatal plate from 1 mm to 3 mm has not shown any significant effect on the phonation. PMID:24959508

  5. [Clinical autopsy evaluation].

    PubMed

    Sakugawa, H; Saito, A

    1999-01-01

    The hospital autopsy rate in Japan dropped from 63.5 per cent in 1972 to 20.9 per cent in 1995. This reduction is attributable to declining interest by clinicians, surgeons and pathologists. The decline is a very serious problem, because the autopsy contributes to what has been called "quality control" of medical care. However, the method of autopsy should change along with advances in diagnostic technology or various changes in the circumstances surrounding medical practice. The most important problem at present is that autopsies require both time and effort. Delayed autopsy reports by pathologists may result in declined interest by clinicians and thus limit the benefits. To shorten the time delay for autopsy reports, clinicians must clarify their clinical questions concerning the deceased patient so that pathologists can readily identify the patients' problems and determine the causes more promptly, clearly and diplomatically. Other suggestions for improvement include the following: the reports should be simpler; the concept that all autopsies must be complete should be eliminated; a hospital accreditor must emphasize that clinicians intend to gain more precise diagnoses by obtaining post-mortem tissues of various organs using biopsy instruments. In addition, communication between pathologists and clinicians must be active to determine the pathogenesis of disease. PMID:10067363

  6. Clinical Approach to Teacher Evaluation.

    ERIC Educational Resources Information Center

    Tipton, William

    This manual, prepared for the state of Washington, provides tools and strategies aimed at assisting building administrators in clinical approaches to teacher evaluation. The first section provides preliminary thoughts on the evaluation process and discusses the two major problems: acceptance and time. The second section discusses the sources and…

  7. 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. PMID:26977366

  8. 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

  9. 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

  10. Regression of Moral Reasoning during Medical Education: Combined Design Study to Evaluate the Effect of Clinical Study Years

    PubMed Central

    Hren, Darko; Marušić, Matko; Marušić, Ana

    2011-01-01

    Background Moral reasoning is important for developing medical professionalism but current evidence for the relationship between education and moral reasoning does not clearly apply to medical students. We used a combined study design to test the effect of clinical teaching on moral reasoning. Methods We used the Defining Issues Test-2 as a measure of moral judgment, with 3 general moral schemas: Personal Interest, Maintaining Norms, and Postconventional Schema. The test was applied to 3 consecutive cohorts of second year students in 2002 (n = 207), 2003 (n = 192), and 2004 (n = 139), and to 707 students of all 6 study years in 2004 cross-sectional study. We also tested 298 age-matched controls without university education. Results In the cross-sectional study, there was significant main effect of the study year for Postconventional (F(5,679) = 3.67, P = 0.003) and Personal Interest scores (F(5,679) = 3.38, P = 0.005). There was no effect of the study year for Maintaining Norms scores. 3rd year medical students scored higher on Postconventional schema score than all other study years (p<0.001). There were no statistically significant differences among 3 cohorts of 2nd year medical students, demonstrating the absence of cohort or point-of-measurement effects. Longitudinal study of 3 cohorts demonstrated that students regressed from Postconventional to Maintaining Norms schema-based reasoning after entering the clinical part of the curriculum. Interpretation Our study demonstrated direct causative relationship between the regression in moral reasoning development and clinical teaching during medical curriculum. The reasons may include hierarchical organization of clinical practice, specific nature of moral dilemmas faced by medical students, and hidden medical curriculum. PMID:21479204

  11. 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

  12. Quantitative evaluation of approximal contacts in Class 2 composite resin restorations: a clinical study.

    PubMed

    Wang, J C; Charbeneau, G T; Gregory, W A; Dennison, J B

    1989-01-01

    The purpose of this study was to develop an accurate and reproducible intraoral method of measuring the distance between two teeth, and to conduct a clinical pilot study of the effect of placement of a class 2 posterior resin restoration upon this intertooth dimension. A Kaman Sciences KD-2611 noncontact displacement measuring system with a 1U unshielding sensor, based upon the variable resistance of eddy current, was used for the intraoral measurement. Seven patients requiring conservative interproximal restorations (initial placements or replacements) on the premolars were selected. Addition silicone impressions were taken of the posterior quadrants from which low-fusing metal (Cerrolow-136) casts were made. Composite resin copings constructed on modified rubber dam clamps were fabricated for the restoration and adjacent teeth upon these metal casts. Aluminum targets and Plexiglas holders for the sensor were attached to the bow of the rubber dam clamp with light-activated composite resin. Quantitative measurements of intertooth distance were made preoperatively, postoperatively, and at one-week and 4 1/2-month recalls after placement of class 2 composite resin restorations for 11 teeth. Four unrestored premolars served as a control. The data were tabulated and analyzed using one-way analysis of variance. The results indicated that the mean postoperative intercoping distance for restored teeth increased after a multiple wedging technique had been applied during restorative procedure. At the one-week recall, these distances had decreased. The 4 1/2-month measurements showed a further decrease with an average loss of 15 microns from the preoperative baseline. PMID:2639320

  13. Evaluating clinical periodontal measures as surrogates for bacterial exposure: The Oral Infections and Vascular Disease Epidemiology Study (INVEST)

    PubMed Central

    2010-01-01

    Background Epidemiologic studies of periodontal infection as a risk factor for cardiovascular disease often use clinical periodontal measures as a surrogate for the underlying bacterial exposure of interest. There are currently no methodological studies evaluating which clinical periodontal measures best reflect the levels of subgingival bacterial colonization in population-based settings. We investigated the characteristics of clinical periodontal definitions that were most representative of exposure to bacterial species that are believed to be either markers, or themselves etiologic, of periodontal disease. Methods 706 men and women aged ≥ 55 years, residing in northern Manhattan were enrolled. Using DNA-DNA checkerboard hybridization in subgingival biofilms, standardized values for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia were averaged within mouth and summed to define "bacterial burden". Correlations of bacterial burden with clinical periodontal constructs defined by the severity and extent of attachment loss (AL), pocket depth (PD) and bleeding on probing (BOP) were assessed. Results Clinical periodontal constructs demonstrating the highest correlations with bacterial burden were: i) percent of sites with BOP (r = 0.62); ii) percent of sites with PD ≥ 3 mm (r = 0.61); and iii) number of sites with BOP (r = 0.59). Increasing PD or AL severity thresholds consistently attenuated correlations, i.e., the correlation of bacterial burden with the percent of sites with PD ≥ 8 mm was only r = 0.16. Conclusions Clinical exposure definitions of periodontal disease should incorporate relatively shallow pockets to best reflect whole mouth exposure to bacterial burden. PMID:20056008

  14. Evaluation of Study Participant Masking of Intravitreal Injections in a Randomized Clinical Trial

    PubMed Central

    Glassman, Adam R.; Stockdale, Cynthia R.; Beck, Roy W.; Baker, Carl; Bressler, Neil M.

    2012-01-01

    Objective To evaluate the success of masking study participants to treatment allocation using sham intravitreal injections. Methods Eyes were randomized to prompt laser plus sham injections, prompt laser plus intravitreal ranibizumab injections, deferred laser plus intravitreal ranibizumab injections, or prompt laser plus intravitreal triamcinolone injections up to every 16 weeks with sham injections intermittently. All eyes could receive treatment or sham as often as every 4 weeks. Participants with 2 study eyes had one eye randomized to sham+laser and one eye randomized to a real injection group. Sham injections were performed by pressing the syringe hub against the conjunctiva to mimic a real injection. Laser treatment was not masked. At the 1 year visit, participants were asked if they believed the injections received during the study were real, sham, or sometimes real and sometimes sham. Results Among 423 participants with one study eye, the correct assignment was stated by 10% of the sham+prompt laser group, 88% of the ranibizumab+prompt laser group, 90% of the unmasked ranibizumab+deferred laser group, and 44% of the triamcinolone+laser group. Among the 112 participants with 2 study eyes, the correct assignment was stated for 24% of the sham+prompt laser eyes. Conclusions Successful masking of an intravitreal injection can be accomplished when a sham injection procedure carefully mimics a true injection procedure. Masking appears less successful when one eye is receiving a real injection and the other eye is receiving a sham injection or an individual eye sometimes receives a real and sometimes a sham injection. PMID:22332211

  15. Preclinical studies and clinical evaluation of compounds from the genus Epimedium for osteoporosis and bone health.

    PubMed

    Indran, Inthrani Raja; Liang, Ryan Lim Zhen; Min, Tan Ee; Yong, Eu-Leong

    2016-06-01

    The morbidity and mortality associated with fractures due to osteoporosis or "porous bone" contributes significantly to global healthcare costs and will increase exponentially with ageing populations. In menopausal women, the onset of menopause and rapid estrogen withdrawal leads to osteoporotic fractures. Healthy bone requires the coordinated remodeling function of osteoclasts, osteoblasts, and osteocytes in the basic bone multicellular unit, regulated by estrogen, RANKL/OPG, ROS, growth factors, and other kinase signaling pathways. Anti-osteoporotic drugs in current use such as hormone replacement therapy, selective estrogen receptor modulators, and bisphosphonates are designed to target these pathways, but all have their limitations. Extracts of the dried aerial parts of the traditional Chinese medicinal plant Epimedium (Berberidaceae) has long been used for bone health. Some nine Epimedium prenylflavonoid compounds have been reported to target estrogen signaling and other bone morphogenesis pathways in mesenchymal stem cell, osteoblast, and osteoclast cell lineages. Epimedium prenylflavonoids and enriched extracts can exert beneficial effects on bone health in estrogen-deficient and other osteoporosis animal models. The development of sensitive and rapid mass chromatographic techniques to quantify compounds extracted from Epimedium, including icariin and icaritin, has been used to standardize production and to study the pharmacokinetics and metabolism of Epimedium in animal models and humans. Recent clinical trials have reported positive effects on bone health, suggesting that compounds or extracts of Epimedium have the potential to be developed as agents, alone or in combination with other drugs, to prevent or delay the onset of osteoporosis and reduce the risk of hip fractures. PMID:26820757

  16. Clinical Evaluation of the Articulinx Intercarpometacarpal Cushion for the First CMC Joint: A Feasibility Study

    PubMed Central

    van der Veen, Fiente J. C.; White, David N.; Dapper, Mattie M. L.; Griot, J. Peter W. don; Ritt, Marco P. J. F.

    2013-01-01

    Background The Intercarpometacarpal Cushion (ICMC; Articulinx, Cupertino, CA, USA) is an implantable spacer designed as a less invasive surgical treatment for osteoarthritis (OA) of the first carpometacarpal joint (CMC-1). Description of Technique Following local anesthesia and exposure of the joint capsule the ICMC, attached to a needle and suture tethers, is guided into the joint space under fluoroscopic visualization through a dorsal approach. The needle is pulled through the thenar eminence to the opposite side of the hand and, once proper device placement is confirmed, cut free and the joint capsule closed. Patients and Methods Eight female patients (median age 56 years; range, 42-83) were treated and followed for 6 to 24 months. Safety of the implant procedure was evaluated intraoperatively. Pain, joint function, and strength were evaluated at 6 weeks, 3, 6, 12 and 24 months with a Visual Analog Scale (VAS) for pain, the QuickDASH inventory, Canadian Occupational Performance Measure (COPM), and pinch and grip strength measurements. Results At 2 years (n = 6), mean VAS pain scores decreased from 6.3 (± 1.5) to 2.2 (± 1.1) (p < 0.001), mean QuickDASH scores improved from 47 (± 15) to 31 (± 11) (p < 0.10), mean COPM performance scores improved from 5.0 (± 1.2) to 5.5 ( ± 1.3) (p = NS). Mean pinch and grip strength measurements also improved compared with baseline. No serious adverse events occurred. Two device removals occurred, associated with a traumatic event and Stage IV OA with device displacement, at 6 and 9 months respectively. Conclusion The ICMC can be implanted safely. Effectiveness needs to be confirmed in future studies. PMID:24436828

  17. Clinical Evaluation of the Articulinx Intercarpometacarpal Cushion for the First CMC Joint: A Feasibility Study.

    PubMed

    van der Veen, Fiente J C; White, David N; Dapper, Mattie M L; Griot, J Peter W Don; Ritt, Marco P J F

    2013-08-01

    Background The Intercarpometacarpal Cushion (ICMC; Articulinx, Cupertino, CA, USA) is an implantable spacer designed as a less invasive surgical treatment for osteoarthritis (OA) of the first carpometacarpal joint (CMC-1). Description of Technique Following local anesthesia and exposure of the joint capsule the ICMC, attached to a needle and suture tethers, is guided into the joint space under fluoroscopic visualization through a dorsal approach. The needle is pulled through the thenar eminence to the opposite side of the hand and, once proper device placement is confirmed, cut free and the joint capsule closed. Patients and Methods Eight female patients (median age 56 years; range, 42-83) were treated and followed for 6 to 24 months. Safety of the implant procedure was evaluated intraoperatively. Pain, joint function, and strength were evaluated at 6 weeks, 3, 6, 12 and 24 months with a Visual Analog Scale (VAS) for pain, the QuickDASH inventory, Canadian Occupational Performance Measure (COPM), and pinch and grip strength measurements. Results At 2 years (n = 6), mean VAS pain scores decreased from 6.3 (± 1.5) to 2.2 (± 1.1) (p < 0.001), mean QuickDASH scores improved from 47 (± 15) to 31 (± 11) (p < 0.10), mean COPM performance scores improved from 5.0 (± 1.2) to 5.5 ( ± 1.3) (p = NS). Mean pinch and grip strength measurements also improved compared with baseline. No serious adverse events occurred. Two device removals occurred, associated with a traumatic event and Stage IV OA with device displacement, at 6 and 9 months respectively. Conclusion The ICMC can be implanted safely. Effectiveness needs to be confirmed in future studies. PMID:24436828

  18. A Retrospective Study Evaluating the Effectiveness of an Asthma Clinical Pathway in Pediatric Inpatient Practice

    PubMed Central

    Edwards, Elisa; Fox, Kristie

    2008-01-01

    OBJECTIVE To determine if the asthma clinical pathway implemented at Wolfson Children's Hospital reduces the length of hospital stay. To determine if pathway use affected the use of asthma education, the use of appropriate discharge medications based on asthma classification, and readmission rates. METHODS A list of patients aged 2 to 18 years discharged from Wolfson Children's Hospital between September 1, 2004 and August 31, 2006 with the diagnosis of asthma was generated. Medical records of eligible patients were reviewed for demographic information, asthma pathway use, duration of hospital stay in days, readmission rates, receipt of asthma education, and medications prescribed upon discharge. Patients placed on the asthma clinical pathway were compared to a control group with asthma who were matched based on age and discharge date. Length of stay was averaged for each group. Asthma education, discharge medications, and readmission rates were compared between the two groups. RESULTS Forty-three patients placed on the asthma clinical pathway were compared to a 43 patients in the control group that were matched for age and discharge date. Use of the asthma clinical pathway reduced hospital stay by 0.372 days (P = .0373). Receipt of asthma education (P = .3864), the use of appropriate drug therapy prescribed upon discharge (P = .1398), and readmission rates (P = .5486) were unaffected by pathway use. CONCLUSIONS The asthma clinical pathway used at Wolfson Children's Hospital reduces length of hospital stay, but has no bearing on receipt of asthma education, use of appropriate drug therapy upon discharge, or readmission rates. PMID:23055882

  19. Clinical Evaluation of Removable Partial Dentures on the Periodontal Health of Abutment Teeth: A Retrospective Study

    PubMed Central

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

    2015-01-01

    The aim of this retrospective study was to evaluate the effect of removable partial dentures in periodontal abutment teeth in relation to the type of denture support and design of RPD in a five-year worn period. Methods : A total of 64 patients with removable partial dentures (RPDs), participated in this study. It were examined ninety-one RPDs. There were seventy-five RPDs with clasp-retained and sixteenth were RPDs with attachments. There were 28 females and 36 males, aged between 40-64 years, 41 maxillary and 50 mandible RPDs. For each subjects the following data were collected: denture design, denture support, and Kennedy classification. Abutment teeth were assessed for plaque index (PI), calculus index (CI), blending on probing (BOP), probing depth (PD), gingival recession (GR), tooth mobility (TM). Level of significance was set at p<0.05. Results : According to denture support of RPD, BOP, PD, PI, GR, CI and TM-index showed no statistically significant difference. Based on the denture design of RPD’s, BOP, PD, PI, CI, and TM-index proved no statistically significant difference. Except GR-index according to denture design confirmed statistically significant difference in RPD with clasp p<0.01. The higher values of all periodontal parameter as BOP, PD, PI, CI and TM were in patients with RPD’s with claps comparing with RPD’s with attachment. Conclusion : RPD’s with clasp increased level of gingival inflammation in regions covered by the dentures and below the clasp arms in abutment teeth. PMID:25926896

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

    PubMed

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

    2015-01-01

    The aim of this retrospective study was to evaluate the effect of removable partial dentures in periodontal abutment teeth in relation to the type of denture support and design of RPD in a five-year worn period. Methods : A total of 64 patients with removable partial dentures (RPDs), participated in this study. It were examined ninety-one RPDs. There were seventy-five RPDs with clasp-retained and sixteenth were RPDs with attachments. There were 28 females and 36 males, aged between 40-64 years, 41 maxillary and 50 mandible RPDs. For each subjects the following data were collected: denture design, denture support, and Kennedy classification. Abutment teeth were assessed for plaque index (PI), calculus index (CI), blending on probing (BOP), probing depth (PD), gingival recession (GR), tooth mobility (TM). Level of significance was set at p<0.05. Results : According to denture support of RPD, BOP, PD, PI, GR, CI and TM-index showed no statistically significant difference. Based on the denture design of RPD's, BOP, PD, PI, CI, and TM-index proved no statistically significant difference. Except GR-index according to denture design confirmed statistically significant difference in RPD with clasp p<0.01. The higher values of all periodontal parameter as BOP, PD, PI, CI and TM were in patients with RPD's with claps comparing with RPD's with attachment. Conclusion : RPD's with clasp increased level of gingival inflammation in regions covered by the dentures and below the clasp arms in abutment teeth. PMID:25926896

  1. 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) PMID:3906906

  2. Evaluation of factors affecting mortality in Fournier’s Gangrene: Retrospective clinical study of sixteen cases

    PubMed Central

    Oymacı, Erkan; Coşkun, Ali; Yakan, Savaş; Erkan, Nazif; Uçar, Ahmet Deniz; Yıldırım, Mehmet

    2014-01-01

    Objective: Fournier’s gangrene is a progressive, necrotizing fasciitis due to synergistic infection of the perineum and external genitalia that is associated with high mortality and morbidity. The purpose of this study is to review the diagnostic and treatment methods that effect mortality in Fournier’s gangrene. Material and Methods: Sixteen patients who were diagnosed and treated at our clinic between 2011 and 2013 due to Fournier’s gangrene were retrospectively analyzed. The surviving and non-surviving patient groups were compared in terms of age, sex, onset time of symptoms, isolated microorganisms, concomitant diseases, Fournier’s gangrene severity index (FGSI), and length of hospital stay. Results: Ten of our cases (62.5%) were male and six (37.5%) were female, with a mean age of 61.2±12.3 (42–73) years. The mortality rate was 18.8% (3 cases). The mean duration of symptoms before admission was 4.31±1.81 (2–8) days. This period was 6.67±1.52 days in patients who succumbed to death, and 3.77±1.42 days in patients who survived (p=0.007). Ten cases (62.5%) had concomitant diabetes mellitus. The most common organism isolated in wound cultures was Escherichia coli (68.7%), and Acinetobacter baumannii, Proteus mirabilis, methicillin-resistant Staphylococcus aureus and Enterococcus spp. in the remaining patients. The mean FGSI of surviving patients was 3.84±1.77, and 7.66±0.57 in fatal cases (p=0.003). The mean length of hospital stay was 25.5 days (2–57) and duration of hospitalization was significantly longer in survivors (p<0.05). Conclusion: The delay in diagnosis and higher FGSI may be responsible for worsening of prognosis and mortality in Fournier’s gangrene. Early diagnosis and determination of the severity of the disease, aggressive surgical debridement and appropriate antimicrobial therapy may improve prognosis. PMID:25931901

  3. 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. PMID:20703753

  4. Implant stability evaluation by resonance frequency analysis in the fit lock technique. A clinical study.

    PubMed

    Falisi, Giovanni; Galli, Massimo; Velasquez, Pedro Vittorini; Rivera, Juan Carlos Gallegos; Di Paolo, Carlo

    2013-01-01

    Surgical procedures for the application of implants in the lateral-superior sectors are affected by the availability of the residual bone. When this condition is lower than 5 mm it is recommended that techniques involving two therapeutic phases, a reconstructive and an applicative one, as reported in the international literature, are adopted. The authors propose here a new method with the potential to apply implants simultaneously with the reconstructive phase. The aim of this longitudinal retrospective study was to evaluate the stability of implants applied with the fit lock technique in the upper maxillarys in us with bone availability lower than 4 mm by measuring resonance frequency at different follow-up periods The seme as urements, carried out on 30 implants, were analysed with specific statistical procedures. The results indicate that the stability of the implants inserted with the fit lock method increases progressively over time in a statistically significant manner. The stability recorded after one year from the insertion (ISQ T2) is significantly higher than that recorded after six months (ISQ T1), and this is significantly higher than that recorded at the time of implant placement (ISQ T0). The implants inserted in the maxillary zones with scarce bone availability and applied with this technique showed a similar stability as reported with other techniques. In light of the results, the authors confirm that the primary stability represents the basic requirement to guarantee a correct healing of the implant and demonstrate that the fit lock technique also all ows reaching this condition when bone availability is minimal. PMID:23991271

  5. 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

  6. 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

  7. Hemodialysis safety: Evaluation of clinical practice.

    PubMed

    Fadili, Wafaa; Adnouni, Adil; Laouad, Inass

    2016-05-01

    Hemodialysis (HD) safety has become a clinical priority; therefore, the use of checklists for making the dialysis session safe is now widely adopted. The aim of our study was to assess different shortcomings in the clinical practice of nurses working in different Moroccan dialysis centers and to discuss the interest of using such checklists. This cross-sectional study was performed in 13 chronic HD centers. Clinical practice of nurses was evaluated through checklists used in European outpatient dialysis units. We noted several deficiencies mainly related to the clinical evaluation of dialysis patients and to aspects related to hygiene and protection measures against contamination. Optimal safety of dialysis sessions requires the use of simple and reproducible means that improve clinical skills of the health staff. PMID:27215249

  8. Clinical evaluation of contemporary oxygenators.

    PubMed

    Stanzel, Roger D P; Henderson, Mark

    2016-01-01

    Advances in cardiopulmonary bypass equipment have played a critical role in improving outcomes for cardiac surgery patients. Recent advancements include reduced priming volumes, biocompatible coatings and gaseous microemboli handling, as well as the incorporation of an arterial filter into the oxygenator.The purpose of this study was to conduct a comprehensive clinical evaluation of adult oxygenators on the market. Oxygenators assessed included the Sorin Synthesis(®) (n = 30), the Sorin Inspire 6F(®) (n = 10) and Inspire 8F(®) (n = 30), the Terumo FX15(®) (n = 13) and FX25(®) (n = 30), the Maquet Quadrox-i(®) (n = 30) and the Medtronic Fusion(®) (n = 30). Parameters assessed included functional prime volumes, gas exchange, pressure gradients and the effects on patient hematology.The Synthesis had the largest functional prime volume (1426 ml), the FX15 the lowest (956 ml). The Inspire 6F, 8F and Fusion had the greatest O2 transfer. The Sorin oxygenators required the lowest sweep gas flows to obtain a PaCO2 of 40 mmHg. The Sorin oxygenators had the largest pressure gradients. While no differences were observed for hemoglobin and platelet levels post cross-clamp removal, the Sorin Synthesis and Inspire 8F had the largest increases in white blood cell (WBC) counts (122% and 141% of baseline, respectively) and neutrophils (162% and 185% of baseline, respectively).The data demonstrate that no single product is superior in all aspects. The choice of ideal oxygenator depends on the aspect(s) of oxygenator performance the perfusion team believes most clinically acceptable based on available data. PMID:26407816

  9. Meniscal regeneration with copolymeric collagen scaffolds. In vitro and in vivo studies evaluated clinically, histologically, and biochemically.

    PubMed

    Stone, K R; Rodkey, W G; Webber, R; McKinney, L; Steadman, J R

    1992-01-01

    We sought to create a regeneration template for the meniscal cartilage of the knee to induce complete meniscal regeneration, and to develop the technique for implanting the prosthetic appliance in vivo. We designed a resorbable collagen-based scaffold and conducted in vitro and in vivo studies. In vivo, the scaffold was implanted in the knees of immature swine and mature canines and evaluated clinically, histologically, and biochemically. Because the canine stifle joint meniscus is more clinically relevant to the human meniscus, this paper emphasizes those results. We studied 24 mixed breed dogs (14 males and 10 females) with an average weight of 25.5 kg (range, 20 to 35) that were obtained from a USDA-licensed supplier. The dogs were deemed clinically and radiographically skeletally mature. None of the dogs had a preexisting knee joint abnormality. All dogs underwent an 80% subtotal resection of the medial meniscus bilaterally. A collagen template was implanted in one stifle (N = 24). The contralateral side served as a control: 12 dogs had a total resection alone and the other 12 dogs had an immediate replantation of the autologous meniscus. Results were tabulated at 3, 6, 9, and 12 months. At final evaluation, before the animals were euthanized, the results were submitted for statistical analysis as well as histologic and biochemical analyses. The results demonstrated that a copolymeric collagen-based scaffold can be constructed that is compatible with meniscal fibrochondrocyte growth in vitro and in vivo, that does not inhibit meniscal regeneration in an immature pig, and that may induce regeneration of the meniscus in the mature dog.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:1558234

  10. Clinical evaluation of meniscus repair with a bioabsorbable arrow: a 2- to 3-year follow-up study.

    PubMed

    Ellermann, A; Siebold, R; Buelow, J U; Sobau, C

    2002-09-01

    In a clinical study with the bioabsorbable Bionx Meniscus Arrow we prospectively evaluated 113 consecutive patients (113 menisci) after all-inside meniscus repair. Repairs were performed in either the medial (80.5%) or lateral (19.5%) posterior horn in the red-red or red-white meniscal zone; 66% of patients underwent concomitant ACL reconstruction. Assessment was based on history, clinical examination, and Lysholm [37] and Cincinnati Knee Scores. After a mean follow-up was 33 months (range 24-43; n=105) 21 (20%) patients showed signs and symptoms consistent with a meniscus tear (16 medial, 5 lateral) and underwent partial meniscectomy. In 11 (52%) of the revised patients concomitant ACL reconstruction was performed; 4 (19%) of revised patients were older than 35 years. In the nonrevised the average Lysholm Score was 92.5 and the average Cincinnati Score 90.4. Two patients showed a distinct femoral cartilage damage. Patient's age did not significantly affect the revision rate. Meniscus repair with the bioabsorbable arrow leads to clinical results comparable to those of traditional suture techniques. When stabilized, patients with concomitant ACL reconstruction showed comparable results to patients without ACL rupture. The simple and time saving all-inside insertion obviates the need for additional incisions and avoids knot tying. A proper tear selection and arrow positioning is necessary and should avoid cartilage damage. PMID:12355303

  11. 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

  12. 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

  13. A combined approach of bedside clinical examination and flexible endoscopic evaluation of swallowing in poststroke dysphagia: A pilot study

    PubMed Central

    Radhakrishnan, Sureshkumar; Menon, Unnikrishnan K; Anandakuttan, Anandkumar

    2013-01-01

    Background: As with most neurologic conditions, stroke involves impairment of the swallowing mechanism. This could be a spectrum of issues, the worst of which is aspiration. At the same time, the prolonged presence of a naso-gastric tube (NGT) has its own morbidity. Flexible endoscopic evaluation of swallowing (FEES) is one reliable method to assess the structural and functional status of the oropharynx and larynx, during the swallowing process. Objective: To study the utility of FEES in decision-making with respect to resumption of oral intake in stroke patients. To document the findings of FEES in stroke patients, and to look for correlations between these and the site of stroke. Materials and Methods: Protocol insertion of naso-gastric tube in all stroke patients, at presentation. Initial assessment by a neurologist and swallowing therapist, depending on cognitive status of the patient. All patients underwent MRI Brain with diffusion weighted sequences. After detailed clinical examination, they underwent swallow exercises under the supervision of a trained swallowing therapist. The decision to remove NGT was taken clinically by the combined decision of neurologist and swallowing therapist. Then all patients underwent FEES by the ENT surgeon. The final decision for NGT removal was taken as per the FEES findings. Result: Sixteen stroke patients underwent the FEES procedure during a period of six months. The oropharyngeal and laryngeal findings varied depending on the area of stroke involvement. Of these, change in decision regarding swallowing rehabilitation or NGT removal was needed in four patients, following the FEES findings. Conclusions: FEES is an easy, efficient and reliable method to evaluate the swallowing status in stroke patients. In combination with good bedside clinical examination and swallow exercises, it can be a good tool in assessing patients with post- stroke dysphagia. Post-stroke rehabilitation and prevention of aspiration pneumonia can be

  14. 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

  15. 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

  16. Evaluation of the antibacterial activities of calcium hydroxide, chlorhexidine, and camphorated paramonochlorophenol as intracanal medicament. A clinical and laboratory study.

    PubMed

    Barbosa, C A; Gonçalves, R B; Siqueira, J F; De Uzeda, M

    1997-05-01

    The antibacterial activities of camphorated paramonochlorophenol, chlorhexidine, and calcium hydroxide were compared using a clinical and laboratory evaluation. In the clinical experiment, root canals that yielded positive cultures a week after complete chemomechanical preparation and camphorated paramonochlorophenol dressing were medicated with one of the three substances tested. Postmedication samples were taken from the canal 1 week later. In the laboratory experiment, the agar diffusion test was used to evaluate the inhibitory activity of the medicaments against bacteria commonly found in endodontic infections. The results of the clinical evaluation showed that all medicaments were effective in reducing or eliminating the endodontic microbiota, as demonstrated by the incidence of negative cultures. There was no statistically significant difference among the medicaments tested. In the laboratory evaluation, camphorated paramonochlorophenol showed the largest zones of bacterial inhibition against all bacterial strains tested. PMID:9545931

  17. 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

  18. Expanding the Grading of Recommendations Assessment, Development, and Evaluation (Ex-GRADE) for Evidence-Based Clinical Recommendations: Validation Study

    PubMed Central

    Phi, Linda; Ajaj, Reem; Ramchandani, Manisha H; Brant, Xenia MC; Oluwadara, Oluwadayo; Polinovsky, Olga; Moradi, David; Barkhordarian, Andre; Sriphanlop, Pathu; Ong, Margaret; Giroux, Amy; Lee, Justin; Siddiqui, Muniza; Ghodousi, Nora; Chiappelli, Francesco

    2012-01-01

    Clinicians use general practice guidelines as a source of support for their intervention, but how much confidence should they place on these recommendations? How much confidence should patients place on these recommendations? Various instruments are available to assess the quality of evidence of research, such as the revised Wong scale (R-Wong) which examines the quality of research design, methodology and data analysis, and the revision of the assessment of multiple systematic reviews (R-AMSTAR), which examines the quality of systematic reviews. The Grading of Recommendation Assessment, Development, and Evaluation (GRADE) Working Group developed an instrument called the GRADE system in order to grade the quality of the evidence in studies and to evaluate the strength of recommendation of the intervention that is proposed in the published article. The GRADE looks at four factors to determine the quality of the evidence: study design, study quality, consistency, and directness. After combining the four components and assessing the grade of the evidence, the strength of recommendation of the intervention is established. The GRADE, however, only makes a qualitative assessment of the evidence and does not generate quantifiable data. In this study, we have quantified both the grading of the quality of evidence and also the strength of recommendation of the original GRADE, hence expanding the GRADE. This expansion of the GRADE (Ex-GRADE) permits the creation of a new instrument that can produce tangible data and possibly bridge the gap between evidence-based research and evidence-based clinical practice. PMID:22303416

  19. The role of aortic compliance in determination of coarctation severity: lumped parameter modeling, in vitro study and clinical evaluation

    PubMed Central

    Keshavarz-Motamed, Zahra; Edelman, Elazer R.; Motamed, Payam K.; Garcia, Julio; Dahdah, Nagib; Kadem, Lyes

    2015-01-01

    Early detection and accurate estimation of the extent of coarctation of the aorta (COA) is critical to long-term outcome. Peak-to-peak trans-coarctation pressure gradient (PKdP) higher than 20 mmHg is an indication for interventional/surgical repair. Patients with COA have reduced proximal and distal aortic compliances. A comprehensive study investigating the effects of variations of proximal COA and systemic compliances on PKdP, and consequently on the COA severity evaluation has never been done. This study evaluates the effect of aortic compliance on diagnostic accuracy of PKdP. Lumped parameter modeling and in vitro experiments were performed for COA severities of 50%, 75% and 90% by area. Modeling and in vitro results were validated against retrospective clinical data of PKdP, measured in fifty-four patients with COA. Modeling and in vitro. PKdP increases with reduced proximal COA compliance (+36%, +38% and +53% for COA severities of 50%, 75% and 90%, respectively; p<0.05), but decreases with reduced systemic compliance (−62%, −41% and −36% for COA severities of 50%, 75% and 90%, respectively; p<0.01). Clinical study. PKdP has a modest correlation with COA severity (R=0.29). The main determinants of PKdP are COA severity, stroke volume index and systemic compliance. Systemic compliance was found to be as influential as COA severity in PKdP determination (R=0.30 vs. R=0.34). In conclusion, PKdP is highly influenced by both stroke volume index and arterial compliance. Low values of PKdP cannot be used to exclude the severe COA presence since COA severity may be masked by reduced systemic compliance and/or low flow conditions. PMID:26596718

  20. Potential reasons for differences in CAD effectiveness evaluated using laboratory and clinical studies

    NASA Astrophysics Data System (ADS)

    He, Xin; Samuelson, Frank; Zeng, Rongping; Sahiner, Berkman

    2015-03-01

    Research studies have investigated a number of factors that may impact the performance assessment of computer aided detection (CAD) effectiveness, such as the inherent design of the CAD, the image and reader samples, and the assessment methods. In this study, we focused on the effect of prevalence on cue validity (co-occurrence of cue and signal) and learning as potentially important factors in CAD assessment. For example, the prevalence of cases with breast cancer is around 50% in laboratory CAD studies, which is 100 times higher than that in breast cancer screening. Although ROC is prevalence-independent, an observer's use of CAD involves tasks that are more complicated than binary classification, including: search, detection, classification, cueing and learning. We developed models to investigate the potential impact of prevalence on cue validity and the learning of cue validity tasks. We hope this work motivates new studies that investigate previously under-explored factors involved in image interpretation with a new modality in its assessment.

  1. 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

  2. Frozen shoulder: prospective clinical study with an evaluation of three treatment regimens.

    PubMed Central

    Bulgen, D Y; Binder, A I; Hazleman, B L; Dutton, J; Roberts, S

    1984-01-01

    Forty-two patients with frozen shoulder were followed up closely for eight months. They were all taught pendular exercises and randomly allocated to one of four treatment groups: (a) intraarticular steroids, (b) mobilisations , (c) ice therapy, (d) no treatment. This study has shown that there is little long-term advantage in any of the treatment regimens but that steroid injections may benefit pain and range of movement in the early stages of the condition. PMID:6742895

  3. Quantitative evaluation of microvessel density using CD34 in clinical variants of ameloblastoma: An immunohistochemical study

    PubMed Central

    Pereira, Treville; Dodal, Shashibhushan; Tamgadge, Avinash; Bhalerao, Sudhir; Tamgadge, Sandhya

    2016-01-01

    Background: Odontogenic epithelium plays an important role in the histogenesis of odontogenic tumors of the jaws. Ameloblastomas, which arise from odontogenic epithelium, are considered benign with little tendency to metastasize. Tumors require an adequate supply of oxygen and a way to remove their waste products. This can be achieved by angiogenesis. In situ quantification of the microvessel density (MVD) is a usual method for assessing angiogenesis. Moreover, angiogenesis may differ in subtypes of ameloblastomas and could play a role in determining the pattern of tumor growth. Aim: The aim of the present study was to demonstrate the expression of cluster of differentiation (CD34) in variants of ameloblastomas and to correlate and compare their expression to the aggressive behavior. Materials and Methods: A retrospective cross-sectional study which included forty paraffin blocks was conducted after obtaining ethical committee clearance. Ten cases of pyogenic granuloma were used as a positive control and thirty cases were of solid multicystic ameloblastoma (SMA), unicystic ameloblastoma (UA) and desmoplastic ameloblastomas. Angiogenesis was assessed using CD34 antigen and was immunohistochemically localized. Statistical analysis was carried out for comparative analysis with the help of ANOVA test, Kolmogorov–Smirnov test and least significance difference test. Results: A significant correlation was obtained between the MVD of all the three variants, i.e., SMA, UA and desmoplastic ameloblastomas which was statistically significant (P < 0.05). Conclusion: Increased MVD in the three variants, i.e., SMA, UA and desmoplastic ameloblastoma seen in the present study could suggest that the angiogenesis has an important role in tumor progression and aggressiveness of ameloblastomas. PMID:27194862

  4. Study to evaluate the aesthetic clinical impact of an autologous antiaging serum.

    PubMed

    Pinto, Hernan; Garrido, Luis G

    2013-03-01

    Since ancient times, humans have fought a still-unwinnable battle against aging and time. The possibility of processing our own blood in order to obtain certain precious substances for a particular purpose has opened the gates for the development of new treatments, indications, and techniques. In this study, we obtained an autologous serum with very high concentrations of some growth factors and anti-inflammatory cytokines using a special syringelike device that exposed the blood to medical-grade glass spheres in a closed system. The application of this autologous conditioned antiaging serum achieved local beauty enhancement results by improving skin hydration, smoothness, and elasticity. PMID:23545916

  5. 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

  6. 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

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

    PubMed Central

    Jahangir, Umar; Khan, Asim Ali; Kapoor, Prem; Jalees, Farhan; Urooj, Shaista

    2014-01-01

    Aim of the Study: The aim of the following study is to evaluate the efficacy and tolerability of a compound Unani formulation in hyperlipidemia on clinical and biochemical parameters. Materials and Methods: A total of 90 patients with total cholesterol level of 220 mg/dl and above were included. In Group ‘A’ thirty patients with total cholesterol 243.5 ± 5.294 mg/dl received Unani formulation safoof-e-muhazzil (SM) in its classical powder form 5 g twice daily orally, in Group ‘B’ thirty patients with total cholesterol 234 ± 3.822 mg/dl received the SM but in compressed tablet form in the same dosage and in Group ‘C’ 30 patients with total cholesterol 242.7 ± 5.563 mg/dl received atorvastatin 10 mg as a standard control. Follow-up was carried out on second, fourth and 6th week and patients were evaluated on clinical as well as biochemical parameters. Results: Group A before treatment had mean total cholesterol of 243.5 ± 5.294 mg/dl which decreased significantly after treatment to 225.6 ± 5.953 mg/dl (P < 0.001) with a percentage change of 7.35%. Group B had mean total cholesterol of 234 ± 3.822 mg/dl which was significantly reduced to 212.67 ± 3.94 mg/dl (P < 0.001) post-treatment with a percentage change of 9.11%. Control Group C having mean total cholesterol of 242.7 ± 5.563 mg/dl before treatment was significantly decreased to 178.73 ± 4.669 mg/dl (P < 0.001) post-treatment with a percentage change of 26.3%. Group A had significant relief 20.72% (P < 0.001) in fatigue, 16.09% (P > 0.5) relief in palpitation and 26.17% (P < 0.001) relief in dyspnea post-treatment. Group B fatigue decreased significantly by 18.14% (P < 0.01), palpitation by 22.91% (P < 0.01) and dyspnea by 20.46% (P < 0.01). In Group C a non-significant increase of 2.2% was observed in fatigue post-treatment, palpitation decreased by 10.22% non-significantly and dyspnea decreased significantly by 17.64% (P < 0.001). Results indicate that the test drug safely and effectively

  8. Evaluating the accuracy of transcribed clinical data.

    PubMed Central

    Wilton, R.; Pennisi, A. J.

    1993-01-01

    This study evaluated the accuracy of data transcribed into a computer-stored record from a handwritten listing of pediatric immunizations. The immunization records of 459 children seen in the UCLA Children's Health Center in March, 1993 were transcribed into a clinical computer system on an ongoing basis. Of these records, 27 (5.9%) were subsequently found to be inaccurate. Reasons for inaccuracy in the transcribed records included incomplete written records, incomplete transcription of written records, and unavailability of immunization records from multiple health-care providers. The utility of a computer-stored clinical record may be adversely affected by unavoidable inaccuracies in transcribed clinical data. PMID:8130478

  9. 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. PMID:23337389

  10. Gynecomastia: Clinical evaluation and management

    PubMed Central

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

    2014-01-01

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

  11. 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

  12. Assessment of inflammatory activity in rheumatoid arthritis: a comparative study of clinical evaluation with grey scale and power Doppler ultrasonography

    PubMed Central

    Naredo, E; Bonilla, G; Gamero, F; Uson, J; Carmona, L; Laffon, A

    2005-01-01

    Objective: To compare the clinical assessment of overall inflammatory activity in patients with rheumatoid arthritis (RA) with grey scale and power Doppler (PD) ultrasonography (US). Methods: Ninety four consecutive patients with RA were included. Demographic and clinical data, C reactive protein (CRP) level, and erythrocyte sedimentation rate (ESR) were recorded for each patient. The presence of tenderness, swelling, and a subjective swelling score from 1 to 3 were independently assessed by two rheumatologists, who reached a consensus in 60 joints examined in each patient. All patients underwent a US examination by a third blinded rheumatologist, using PD. US joint effusion, synovitis, and PD signal were graded from 1 to 3 in the 60 joints. Joint count and joint index for effusion, synovitis, and PD signal were recorded. A 28 joint count for clinical and US variables was calculated. Interobserver reliability of the US examination was evaluated by a fourth blinded rheumatologist. Results: US showed significantly more joints with effusion (mean 15.2) and synovitis (mean 14.6) than clinical examination (mean 11.5, p<0.05). A significant correlation was found between joint count and joint index for swelling, US effusion, synovitis, and PD signal. The 28 joint count for effusion, synovitis, and PD signal correlated highly with the corresponding 60 joint counts. US findings correlated better with CRP and ESR than clinical measures. Interobserver reliability was better for US findings than for clinical assessment. Conclusion: US is a sensitive method for assessing joint inflammatory activity in RA, complementary to clinical evaluation. PMID:15708891

  13. 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

  14. Clinical-pathologic study of stage IIB, III, and IVA carcinoma of the cervix: extended diagnostic evaluation for paraaortic node metastasis--a Gynecologic Oncology Group study.

    PubMed

    Heller, P B; Maletano, J H; Bundy, B N; Barnhill, D R; Okagaki, T

    1990-09-01

    Three hundred twenty patients were entered into GOG Protocol 63, a clinical-pathologic study of stage IIB, III, and IVA cervical carcinoma. Following the completion of FIGO staging prerequisites, patients had computerized tomography (CT), a lymph-angiogram (LAG), and an ultrasound (US) of the aortic area. If any study was positive, a cytologic or histologic evaluation by fine-needle aspiration or selective paraaortic lymphadenectomy was performed. Paraaortic node dissection was mandated for patients with negative extended staging studies. Results of extended staging evaluations were compared with histologic or cytologic results. Two hundred sixty-four patients were eligible and evaluable. One hundred sixty-seven patients (63%) were stage IIB, 89 (34%) were stage III, and 8 (3%) were stage IVA. Positive paraaortic nodes occurred in 21% of stage IIB, 31% of stage III, and 13% of stage IVA. LAG sensitivity was 79% with a specificity of 73%. Sensitivity of CT and US was 34 and 19%, respectively, with specificities of 96 and 99%, respectively. The frequency of false-negative results with LAG for patients with stage IIB disease was 6%. This decrease is consistent with a stable sensitivity and specificity. These findings suggest that a negative LAG may be adequate to eliminate surgical staging in subgroups with low risk of metastasis to the aortic nodes. Until new noninvasive testing methods are developed, LAG appears to be the most reliable noninvasive examination to evaluate spread of cervical cancer to aortic nodes. PMID:2227556

  15. Topical ascorbic acid on photoaged skin. Clinical, topographical and ultrastructural evaluation: double-blind study vs. placebo.

    PubMed

    Humbert, Philippe G; Haftek, Marek; Creidi, Pierre; Lapière, Charles; Nusgens, Betty; Richard, Alain; Schmitt, Daniel; Rougier, André; Zahouani, Hassan

    2003-06-01

    Vitamin C is known for its antioxidant potential and activity in the collagen biosynthetic pathway. Photoprotective properties of topically applied vitamin C have also been demonstrated, placing this molecule as a potential candidate for use in the prevention and treatment of skin ageing. A topically applied cream containing 5% vitamin C and its excipient were tested on healthy female volunteers presenting with photoaged skin on their low-neck and arms in view to evaluate efficacy and safety of such treatment. A double-blind, randomized trial was performed over a 6-month period, comparing the action of the vitamin C cream vs. excipient on photoaged skin. Clinical assessments included evaluation at the beginning and after 3 and 6 months of daily treatment. They were performed by the investigator and compared with the volunteer self assessment. Skin relief parameters were determined on silicone rubber replicas performed at the same time-points. Cutaneous biopsies were obtained at the end of the trial and investigated using immunohistochemistry and electron microscopy. Clinical examination by a dermatologist as well as self-assessment by the volunteers disclosed a significant improvement, in terms of the 'global score', on the vitamin C-treated side compared with the control. A highly significant increase in the density of skin microrelief and a decrease of the deep furrows were demonstrated. Ultrastructural evidence of the elastic tissue repair was also obtained and well corroborated the favorable results of the clinical and skin surface examinations. Topical application of 5% vitamin C cream was an effective and well-tolerated treatment. It led to a clinically apparent improvement of the photodamaged skin and induced modifications of skin relief and ultrastructure, suggesting a positive influence of topical vitamin C on parameters characteristic for sun-induced skin ageing. PMID:12823436

  16. Scaling-Up Access to Antiretroviral Therapy for Children: A Cohort Study Evaluating Care and Treatment at Mobile and Hospital-Affiliated HIV Clinics in Rural Zambia

    PubMed Central

    van Dijk, Janneke H.; Moss, William J.; Hamangaba, Francis; Munsanje, Bornface; Sutcliffe, Catherine G.

    2014-01-01

    Background Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART), but few programs have been evaluated. We compared outcomes for children receiving care in mobile and hospital-affiliated HIV clinics in rural Zambia. Methods Outcomes were measured within an ongoing cohort study of HIV-infected children seeking care at Macha Hospital, Zambia from 2007 to 2012. Children in the outreach clinic group received care from the Macha HIV clinic and transferred to one of three outreach clinics. Children in the hospital-affiliated clinic group received care at Macha HIV clinic and reported Macha Hospital as the nearest healthcare facility. Results Seventy-seven children transferred to the outreach clinics and were included in the analysis. Travel time to the outreach clinics was significantly shorter and fewer caretakers used public transportation, resulting in lower transportation costs and fewer obstacles accessing the clinic. Some caretakers and health care providers reported inferior quality of service provision at the outreach clinics. Sixty-eight children received ART at the outreach clinics and were compared to 41 children in the hospital-affiliated clinic group. At ART initiation, median age, weight-for-age z-scores (WAZ) and CD4+ T-cell percentages were similar for children in the hospital-affiliated and outreach clinic groups. Children in both groups experienced similar increases in WAZ and CD4+ T-cell percentages. Conclusions HIV care and treatment can be effectively delivered to HIV-infected children at rural health centers through mobile ART teams, removing potential barriers to uptake and retention. Outreach teams should be supported to increase access to HIV care and treatment in rural areas. PMID:25122213

  17. 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)

  18. Radiographical and clinical evaluation of critical size defects in rabbit calvaria filled with allograft and autograft: a pilot study.

    PubMed

    Oporto V, Gonzalo H; Fuentes, Ramón; Borie, Eduardo; Del Sol, Mariano; Orsi, Iara Augusta; Engelke, Wilfried

    2014-01-01

    Regeneration of resorbed edentulous sites can be induced by bone grafts from the subject himself and/or by the use of biomaterials. At present, there has been an extensive search for biomaterials that are evaluated by artificially creating one or more critical defects. The aim of this work was to clinically and radiographically analyze bone formation by the use of some biomaterials in artificially created defects in the parietal bone of rabbits. Six rabbits were used, creating defects of 8 mm in diameter in parietal bones. One defect was maintained with coagulum only, and in others, freeze-dried bone allograft (FDBA), autologous bone, and a combination of autologous bone with FDBA respectively, were added. Animals were sacrificed at 15-90 days with 2 weeks interval each, and calvaria were analyzed macroscopically, measuring by digital caliper the lack of filling at the surface of defects, identifying limits at anteroposterior and coronal view, realizing a digital photograph register of their external surfaces. This was subsequently evaluated radiographically by occlusal film radiography used to quantify its density through software. In conclusion, autologous bone showed the best behavior, clinically as well as radiographically. However, FDBA is a good option as an alternative to autologous bone as its behavior was slightly lower over time. The combination of autologous bone and FDBA in the same defect showed results considerably inferior to grafts used separately. Low radiopacity and clear limits were observed through time for the control coagulum filled defect. PMID:25126163

  19. Radiographical and clinical evaluation of critical size defects in rabbit calvaria filled with allograft and autograft: a pilot study

    PubMed Central

    Oporto V, Gonzalo H; Fuentes, Ramón; Borie, Eduardo; del Sol, Mariano; Orsi, Iara Augusta; Engelke, Wilfried

    2014-01-01

    Regeneration of resorbed edentulous sites can be induced by bone grafts from the subject himself and/or by the use of biomaterials. At present, there has been an extensive search for biomaterials that are evaluated by artificially creating one or more critical defects. The aim of this work was to clinically and radiographically analyze bone formation by the use of some biomaterials in artificially created defects in the parietal bone of rabbits. Six rabbits were used, creating defects of 8 mm in diameter in parietal bones. One defect was maintained with coagulum only, and in others, freeze-dried bone allograft (FDBA), autologous bone, and a combination of autologous bone with FDBA respectively, were added. Animals were sacrificed at 15-90 days with 2 weeks interval each, and calvaria were analyzed macroscopically, measuring by digital caliper the lack of filling at the surface of defects, identifying limits at anteroposterior and coronal view, realizing a digital photograph register of their external surfaces. This was subsequently evaluated radiographically by occlusal film radiography used to quantify its density through software. In conclusion, autologous bone showed the best behavior, clinically as well as radiographically. However, FDBA is a good option as an alternative to autologous bone as its behavior was slightly lower over time. The combination of autologous bone and FDBA in the same defect showed results considerably inferior to grafts used separately. Low radiopacity and clear limits were observed through time for the control coagulum filled defect. PMID:25126163

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

    PubMed Central

    2013-01-01

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

  1. 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

  2. Clinical evaluation of anticalculus dentifrices.

    PubMed

    Kazmierczak, M; Mather, M; Ciancio, S; Fischman, S; Cancro, L

    1990-01-01

    One hundred and eighty-seven patients participated in a six-month study to evaluate the calculus-inhibiting effect of a zinc citrate dentifrice compared to Crest Tartar Control and a placebo, Crest Regular. The findings demonstrate a statistically significant calculus prevention benefit over Crest Regular for both Crest Tartar Control and a 2% zinc citrate/silica product. Compared to the control, the zinc citrate product reduced calculus formation by 32.3%, and Crest Tartar Control reduced it by 21.4%. These findings also demonstrate no statistically significant difference in stain or soft tissue status among the three dentifrices. All products were found to be safe to oral tissues and acceptable for taste. PMID:2376102

  3. Clinical and immunological evaluation after BCG-id vaccine in leprosy patients in a 5-year follow-up study

    PubMed Central

    Zenha, Erika Muller Ramalho; Wambier, Carlos Gustavo; Novelino, Ana Lúcia; de Andrade, Thiago Antônio Moretti; Ferreira, Maria Aparecida Nunes; Frade, Marco Andrey Cipriani; Foss, Norma Tiraboschi

    2012-01-01

    Introduction The use of bacillus Calmette–Guérin (BCG) has long been considered a stimulus for immune reactivity in leprosy household contacts. Probably, the combination of multidrug therapy with BCG could facilitate the clearance of leprosy bacilli in the host, reduce relapse rates, and shorten the duration of skin-smear positivity. Methods To investigate the mechanism of action of BCG, a study involving 19 leprosy patients, eleven multibacillary (MB) and eight paucibacillary, was performed to assess the in vitro production of interleukin (IL)-10, interferon (IFN)-γ, tumor necrosis factor (TNF)-α, IL-6, and IL-17 in the supernatant of peripheral blood mononuclear cells, before and 30 days after inoculation with BCG intradermally (BCG-id). Peripheral blood mononuclear cells isolated by Ficoll–Hypaque gradient were cultivated with Concanavalin-A (Con-A), lipopolysccharides (LPS), or BCG. The supernatant was collected for ELISA quantification of cytokines. The immunohistochemistry of IFN-γ, IL-1, IL-10, IL-12, transforming growth factor (TGF)-β, and TNF-α was carried out in biopsies of skin lesions of leprosy patients before and 30 days after inoculation of BCG-id. These patients were followed up for 5 years to assess the therapeutic response to multidrug therapy, the occurrence of leprosy reactions, and the results of bacterial index and anti-PGL-1 serology after the end of treatment. Results The results showed increased production of cytokines after BCG-id administration in MB and paucibacillary leprosy patients. There was statistically higher levels of TNF-α (P = 0.017) in MB patients and of IL-17 (P = 0.008) and IFN-γ (P = 0.037) in paucibacillary patients. Immunohistochemical staining, especially for TNF-α, was more intense in biopsies of MB leprosy patients taken after BCG-id administration, probably for induction of innate human immunity. The clinical evaluation suggests that BCG-id is able to induce a more effective therapeutic response, with

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

    PubMed Central

    Nadkerny, Purnima Vidyesh; Ravishankar, Potluri Leela; Pramod, Virupapuram; Agarwal, Lavanya Abhay; Bhandari, Saurabh

    2015-01-01

    Background: The aim of our clinical trial was to assess and compare the antiplaque and anti-inflammatory potential of a probiotic mouthwash with 0.2% chlorhexidine and saline. Materials and Methods: A randomized parallel group study was designed for a period of 4 weeks on 45 systemically healthy subjects between 20 and 30 years having chronic gingivitis. The study population was divided into three groups. Group A - 15 subjects were advised experimental (probiotic) mouthwash. Group B - 15 subjects were advised positive control (chlorhexidine) mouthwash and Group C - 15 subjects into a negative control group (normal saline). Oral prophylaxis was done for all groups at baseline. After the proper oral hygiene instructions, all the three groups were instructed to rinse their mouth with 10 ml of their respective mouthrinse, undiluted for 1 min twice daily, 30 min after brushing. Clinical parameters such as plaque index (PI), gingival index (GI), and oral hygiene index simplified (OHI-S) were assessed at baseline, 2 weeks and 4 weeks, respectively. Results: At day 28, the PI, GI, and OHI-S were significantly reduced by all treatment modalities ranking probiotic and chlorhexidine is greater than saline. Conclusion: The probiotic mouthrinses tested was effectively used as an adjunct to mechanical plaque control in the prevention of plaque and gingivitis. Thus, the probiotic mouthrinse has a great therapeutic potential. PMID:26941513

  5. 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

  6. Evaluation of clinical course and neurocognition in children with self-limited infantile epilepsy in a Turkish cohort study.

    PubMed

    Bozaykut, Abdulkadir; Aksoy, Halil Ural; Sezer, Rabia Gönül; Polat, Muzaffer

    2015-03-01

    The outcome of children with self-limited infantile epilepsy was reported to be normal psychosocial and cognitive development as a characteristic criterion. We aimed to investigate the clinical course and neurocognitive outcome in children with self-limited infantile epilepsy in a Turkish cohort. The clinical course, electroencephalographic (EEG) characteristics, neuroimaging, treatment, and outcome of children with self-limited infantile epilepsy were retrospectively analyzed. All infants were reevaluated with the Denver Developmental Screening Test in addition to neurologic examination. Of 44 patients, self-limited familial infantile epilepsy was diagnosed in 8 infants (18.2%) and self-limited nonfamilial infantile epilepsy in 28 (63.6%). Interictal EEGs and neurologic examinations were normal in all cases. Fine motor and gross motor skills, language, adaptive personal/social skills were near-normal in all patients with self-limited familial infantile epilepsy. Delay in language parameters was observed in 2 infants with self-limited nonfamilial infantile epilepsy. Language skills should be thoroughly evaluated with detailed neurocognitive screening tests in patients with self-limited infantile epilepsy. PMID:24958006

  7. The clinical performance evaluation of novel protein chips for eleven biomarkers detection and the diagnostic model study

    PubMed Central

    Luo, Yuan; Zhu, Xu; Zhang, Pengjun; Shen, Qian; Wang, Zi; Wen, Xinyu; Wang, Ling; Gao, Jing; Dong, Jin; Yang, Caie; Wu, Tangming; Zhu, Zheng; Tian, Yaping

    2015-01-01

    We aimed to develop and validate two novel protein chips, which are based on microarray chemiluminescence immunoassay and can simultaneously detected 11 biomarkers, and then to evaluate their clinical diagnostic value by comparing with the traditional methods. Protein chips were evaluated for limit of detection, specificity, common interferences, linearity, precision and accuracy. 11 biomarkers were simultaneously detected by traditional methods and protein chips in 3683 samples, which included 1723 cancer patients, 1798 benign diseases patients and 162 healthy controls. After assay validation, protein chips demonstrated high sensitivity, high specificity, good linearity, low imprecision and were free of common interferences. Compared with the traditional methods, protein chips have good correlation in the detection of all the 13 kinds of biomarkers (r≥0.935, P<0.001). For specific cancer detection, there were no statistically significant differences between the traditional method and novel protein chips, except that male protein chip showed significantly better diagnostic value on NSE detection (P=0.004) but significantly worse value on pro-GRP detection (P=0.012), female chip showed significantly better diagnostic value on pro-GRP detection (P=0.005). Furthermore, both male and female multivariate diagnostic models had significantly better diagnostic value than single detection of PGI, PG II, pro-GRP, NSE and CA125 (P<0.05). In addition, male models had significantly better diagnostic value than single CA199 and free-PSA (P<0.05), while female models observed significantly better diagnostic value than single CA724 and β-HCG (P<0.05). For total disease or cancer detection, the AUC of multivariate logistic regression for the male and female disease detection was 0.981 (95% CI: 0.975-0.987) and 0.836 (95% CI: 0.798-0.874), respectively. While, that for total cancer detection was 0.691 (95% CI: 0.666-0.717) and 0.753 (95% CI: 0.731-0.775), respectively. The new

  8. 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. PMID:25326531

  9. 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...

  10. Evaluation of the Success Criteria for Zirconia Dental Implants: A Four-Year Clinical and Radiological Study

    PubMed Central

    Borgonovo, Andrea Enrico; Vavassori, Virna; Calvo-Guirado, Josè Luis; Delgado Ruiz, Rafael Arcesio; Maiorana, Carlo

    2013-01-01

    Objectives. The aim was to evaluate survival and success rates, soft tissue health, and radiographic marginal bone loss (MBL) of zirconia implants placed in the esthetic and posterior areas of the jaws and in association with multiple or single implant restorations after at least 6 months of definitive restoration. Material and Methods. 35 one-piece zirconium implants were utilized for single or partially edentulous ridges rehabilitation. All implants received immediate temporary restorations and six months after surgery were definitively restored. Every 6 months after implant placement, a clinical-radiographic evaluation was performed. For each radiograph, the measurements of MBL were calculated. Results. The results showed that the mean MBL at 48-month followup was 1.631 mm. The mean MBL during the first year of loading was not more significant for implants placed in the first molar regions than for those positioned in other areas. Moreover, no differences in marginal bone level changes were revealed for multiple and single implants, whereas MBL in the first year was observed to be slightly greater for implants placed in the maxilla than for those placed in the mandible. Conclusion. Zirconia showed a good marginal bone preservation that could be correlated with one-piece morphology and characteristics of zirconia implants. PMID:24065992

  11. 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

  12. Performance Evaluation of a Clinical PACS Module

    NASA Astrophysics Data System (ADS)

    Taira, Ricky K.; Cho, Paul S.; Huang, H. K.; Mankovich, Nicholas J.; Boechat, Maria I.

    1989-05-01

    Picture archiving and communication systems (PACS) are now clinically available in limited radiologic applications. The benefits, acceptability, and reliablity of these systems have thus far been mainly speculative and anecdotal. This paper discusses the evaluation of a PACS module implemented in the pediatric radiology section of a 700-bed teaching hospital. The PACS manages all pediatric inpatient images including conventional x-rays and contrast studies (obtained with a computed radiography system), magnetic resonance images, and relevant ultrasound images. A six-monitor workstation is available for image review.

  13. [Understanding and Thinking on America Clinical Evaluation of Medical Devices].

    PubMed

    Yuan, Fuqiang; Yuan, Peng; Deng, Gang

    2015-09-01

    This paper introduces the risk classification and listing way of medical devices in the United States, and according to the contents in various situations, FDA provides the requirements for clinical evaluation. At the same time, through the comparative study on the similarities and differences between USA and our country of the clinical evaluation, the paper puts forward some suggestions. PMID:26904887

  14. [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. PMID:26200364

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

    PubMed

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

    2016-06-01

    Plasma chitotriosidase originates from activated macrophages and is reported to be elevated in many Lysosomal Storage Disorders. Measurement of this enzyme activity has been an available tool for monitoring therapy of Gaucher disease. The degree of elevation of chitotriosidase is useful for differential diagnosis of Gaucher disease and Niemann Pick A/B. However the potential utility of this chitotriosidase assay depends on the frequency of deficient chitotriosidase activity in a particular population. We therefore aim to study the clinical utility of this assay Gaucher and Niemann Pick A/B diseases in the backdrop of chitotriosidase deficiency in our population. The study comprises 173 patients with clinical suspicion of either Gaucher disease (n=108) or Niemann Pick A/B (n=65) and 92 healthy controls. The plasma samples of controls, Gaucher disease, and Niemann Pick A/B showed chitotriosidase deficiency of 12%, 25% and 27% respectively. The degree of elevation of chitotriosidase in Gaucher disease and Niemann Pick A/B patients is 40-326 (11,325.7±6395.4nmol/h/ml) and 7-22 folds (1192.5±463.0nmol/h/ml) respectively. In view of these findings of distinguishable fold elevation of chitotriosidase in Gaucher disease or Niemann Pick A/B, it can be a potential surrogate differential diagnostic marker for these groups of diseases, except in the patients in whom this enzyme is deficient. PMID:26975750

  16. Are Clinical Studies for You?

    MedlinePlus

    ... Page > Participate in Clinical Studies If you are thinking about participating in a Clinical Study at NIH, ... medical care and activities of daily living. In thinking about the risks of research, it is helpful ...

  17. 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

  18. 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

  19. Evaluation of the value of bone training (progressive bone loading) by using the Periotest: A clinical study

    PubMed Central

    Turner, Porus S.; Nentwig, Georg H.

    2014-01-01

    Aim: The aim of this clinical study was to determine if progressive bone loading was effective in improving bone density and rigidity of implants. Materials and Methods: 11 implants were placed with conventional loading and 14 implants were placed with progressive loading. The Periotest instrument was used to assess implant mobility. Mean difference of values were recorded in both qualities of bone. Results: Conventional loading in poor quality bone showed a significant decrease in rigidity of the bone as compared to conventional loading in good quality of bone. Progressive loading in both poor and good quality bone showed a significant increase in bone rigidity. Conclusion: Implants should not be loaded conventionally in poor quality bone but should be progressively loaded to prevent decrease in density and rigidity around implants. PMID:25395760

  20. Evaluation of Students in the Clinical Setting

    ERIC Educational Resources Information Center

    Elenbaas, Robert M.

    1976-01-01

    Some of the concepts and procedures of curricular design and student evaluation utilized by the clinical faculty within the PharmD program at the University of Missouri-Kansas City are described. Specific competencies, curriculum objectives, clinical review conferences, and verbal challenge examinations are appended. (LBH)

  1. Clinical evaluation of giomer- and resin-modified glass ionomer cement in class V noncarious cervical lesions: An in vivo study

    PubMed Central

    Jyothi, KN; Annapurna, S; Kumar, Anil S; Venugopal, P; Jayashankara, CM

    2011-01-01

    Objectives: To evaluate and compare the clinical performance of Giomer (Beautifil II) and RMGIC (Fuji II LC) in noncarious cervical lesions. Materials and Methods: Thirty-two subjects with one or two pairs of noncarious cervical lesions were included in the study. Each pair of lesion was restored with either giomer or RMGIC assigned randomly. Clinical evaluation of restorations was done using USPHS criteria. Data was formulated in a predesigned format and subjected to statistical analysis using the chi square test. Results: Statistically significant difference was found between RMGIC and Giomer with respect to surface roughness with P value <0.001. Conclusion: Giomer showed superior surface finish compared to RMGIC. Both Giomer and RMGIC showed equal retention ability. PMID:22144814

  2. [Metal/metal--a new (old) hip bearing system in clinical evaluation. Prospective 7-year follow-up study].

    PubMed

    Jessen, N; Nickel, A; Schikora, K; Büttner-Janz, K

    2004-05-01

    The problems of wear debris of bearing systems containing polyethylene used in hip arthroplasty have led to an increased trend to hard on hard bearing surfaces. Based on our own good experiences with the cementless Zweymüller-Alloclassic system, we implanted the same system with metal-on-metal bearing surfaces (Metasul) in 100 cases between October 1993 and November 1994. In order to record potential side effects, specific questioning and a clinical and radiological survey were carried out before surgery and in regular intervals thereafter. Up to date almost all of the patients have had good and excellent results with an average of more than 90 points in the Harris hip score (47.8 before surgery). There were no cases of revision surgery as a result of aseptic loosening. Two revisions were performed for other reasons (change of the insert, deep infection). No disadvantageous phenomena related to Metasul in the surrounding tissue were found on macroscopic and histologic investigation. The radiological examination did not show any specific signs pertaining to the use of a metal-on-metal bearing system. We also have no grounds to suppose that there are systemic reactions due to chromium or cobalt ions. Up to now, the new metal-on-metal bearing system in connection with a proven hip arthroplasty system has lived up to clinical expectations. With regard to less wear debris, it is justified to implant it in younger patients as well. Other open questions, in particular the possibly improved long-term results, have to be answered by continuation of the study. PMID:15118821

  3. 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

  4. Clinical evaluation incorporating a personal genome

    PubMed Central

    Ashley, Euan A.; Butte, Atul J.; Wheeler, Matthew T.; Chen, Rong; Klein, Teri E.; Dewey, Frederick E.; Dudley, Joel T.; Ormond, Kelly E.; Pavlovic, Aleksandra; Hudgins, Louanne; Gong, Li; Hodges, Laura M.; Berlin, Dorit S.; Thorn, Caroline F.; Sangkuhl, Katrin; Hebert, Joan M.; Woon, Mark; Sagreiya, Hersh; Whaley, Ryan; Morgan, Alexander A.; Pushkarev, Dmitry; Neff, Norma F; Knowles, Joshua W.; Chou, Mike; Thakuria, Joseph; Rosenbaum, Abraham; Zaranek, Alexander Wait; Church, George; Greely, Henry T.; Quake, Stephen R.; Altman, Russ B.

    2010-01-01

    Background The cost of genomic information has fallen steeply but the path to clinical translation of risk estimates for common variants found in genome wide association studies remains unclear. Since the speed and cost of sequencing complete genomes is rapidly declining, more comprehensive means of analyzing these data in concert with rare variants for genetic risk assessment and individualisation of therapy are required. Here, we present the first integrated analysis of a complete human genome in a clinical context. Methods An individual with a family history of vascular disease and early sudden death was evaluated. Clinical assessment included risk prediction for coronary artery disease, screening for causes of sudden cardiac death, and genetic counselling. Genetic analysis included the development of novel methods for the integration of whole genome sequence data including 2.6 million single nucleotide polymorphisms and 752 copy number variations. The algorithm focused on predicting genetic risk of genes associated with known Mendelian disease, recognised drug responses, and pathogenicity for novel variants. In addition, since integration of risk ratios derived from case control studies is challenging, we estimated posterior probabilities from age and sex appropriate prior probability and likelihood ratios derived for each genotype. In addition, we developed a visualisation approach to account for gene-environment interactions and conditionally dependent risks. Findings We found increased genetic risk for myocardial infarction, type II diabetes and certain cancers. Rare variants in LPA are consistent with the family history of coronary artery disease. Pharmacogenomic analysis suggested a positive response to lipid lowering therapy, likely clopidogrel resistance, and a low initial dosing requirement for warfarin. Many variants of uncertain significance were reported. Interpretation Although challenges remain, our results suggest that whole genome sequencing can

  5. Learn about Clinical Studies

    MedlinePlus

    ... in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. Clinical trials provide the basis for the development and marketing of new drugs, biological products, and medical devices. ...

  6. [Clinical evaluation of thymic function].

    PubMed

    Castermans, E; Morrhaye, G; Marchand, S; Martens, H; Moutschen, M; Baron, F; Beguin, Y; Geenen, V

    2007-11-01

    The essential role of the thymus is to install an extremely diverse repertoire of T lymphocytes that are self-tolerant and competent against non-self, as well as to generate self-antigen specific regulatory T cells (Treg) able to inactivate in periphery self-reactive T cells having escaped the thymic censorship. Although indirect, techniques of medical imaging and phenotyping of peripheral T cells may help in the investigation of thymic function. Nowadays however, thymopoiesis is better evaluated through quantification by PCR of T-cell receptor excision circles (TREC) generated by intrathymic random recombination of the gene segments coding for the variable parts of the T-cell receptor for antigen (TCR). The TREC methodology is very valuable in the circumstances not associated with intense proliferation or apoptosis of peripheral T lymphocytes. PMID:18217644

  7. 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.

  8. 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. PMID:19835041

  9. 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

  10. An evaluation of Polaroid photographic imaging for cutaneous-lesion referrals to an outpatient clinic: a pilot study.

    PubMed

    Singh, S; Stevenson, J H; McGurty, D

    2001-03-01

    A pilot study consisted of 65 patient referrals to a Regional Plastic Surgery Department in which the referral letter, accompanied by a high-quality Polaroid photograph, was assessed by four consultants. The diagnosis, degree of urgency of treatment, grade of surgeon (to undertake the operation) and anticipated time for the procedure were recorded. The results were statistically analysed. Our aim was to evaluate the diagnostic accuracy and consistency of the four observers. The majority of malignant skin lesions were detected accurately; those that were missed received urgent attention due to a high degree of suspicion. This study supports the view that 'triage' of referrals using high-quality photographic images in association with an accurate referral letter can offer a significant reduction in pressure on waiting time and inconvenience for patients by avoiding an additional outpatient visit. Advantages to purchasers in terms of cost savings on outpatient visits and travelling reimbursement can result from this initiative. PMID:11207125

  11. Evaluation and clinical significance of the stomach age model for evaluating aging of the stomach-a multicenter study in China

    PubMed Central

    2014-01-01

    Background A higher prevalence of chronic atrophic gastritis (CAG) occurs in younger adults in Asia. We used Stomach Age to examine the different mechanisms of CAG between younger adults and elderly individuals, and established a simple model of cancer risk that can be applied to CAG surveillance. Methods Stomach Age was determined by FISH examination of telomere length in stomach biopsies. Δψm was also determined by flow cytometry. Sixty volunteers were used to confirm the linear relationship between telomere length and age while 120 subjects were used to build a mathematical model by a multivariate analysis. Overall, 146 subjects were used to evaluate the validity of the model, and 1,007 subjects were used to evaluate the relationship between prognosis and Δage (calculated from the mathematical model). ROC curves were used to evaluate the relationship between prognosis and Δage and to determine the cut-off point for Δage. Results We established that a tight linear relationship between the telomere length and the age. The telomere length was obvious different between patients with and without CAG even in the same age. Δψm decreased in individuals whose Stomach Age was greater than real age, especially in younger adults. A mathematical model of Stomach Age (real age + Δage) was successfully constructed which was easy to apply in clinical work. A higher Δage was correlated with a worse outcome. The criterion of Δage >3.11 should be considered as the cut-off to select the subgroup of patients who require endoscopic surveillance. Conclusion Variation in Stomach Age between individuals of the same biological age was confirmed. Attention should be paid to those with a greater Stomach Age, especially in younger adults. The Δage in the Simple Model can be used as a criterion to select CAG patients for gastric cancer surveillance. PMID:25057261

  12. 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)

  13. Clinical evaluation of subepithelial connective tissue graft and guided tissue regeneration for treatment of Miller’s class 1 gingival recession (comparative, split mouth, six months study)

    PubMed Central

    Bhavsar, Neeta-V.; Dulani, Kirti; Trivedi, Rahul

    2014-01-01

    Objectives: The present study aims to clinically compare and evaluate subepithelial connective tissue graft and the GTR based root coverage in treatment of Miller’s Class I gingival recession. Study Design: 30 patients with at least one pair of Miller’s Class I gingival recession were treated either with Subepithelial connective tissue graft (Group A) or Guided tissue regeneration (Group B). Clinical parameters monitored included recession RD, width of keratinized gingiva (KG), probing depth (PD), clinical attachment level (CAL), attached gingiva (AG), residual probing depth (RPD) and % of Root coverage(%RC). Measurements were taken at baseline, three months and six months. A standard surgical procedure was used for both Group A and Group B. Data were recorded and statistical analysis was done for both intergroup and intragroup. Results: At end of six months % RC obtained were 84.47% (Group A) and 81.67% (Group B). Both treatments resulted in statistically significant improvement in clinical parameters. When compared, no statistically significant difference was found between both groups except in RPD, where it was significantly greater in Group A. Conclusions: GTR technique has advantages over subepithelial connective tissue graft for shallow Miller’s Class I defects and this procedure can be used to avoid patient discomfort and reduce treatment time. Key words:Collagen membrane, comparative split mouth study, gingival recession, subepithelial connective tissue graft, guided tissue regeneration (GTR). PMID:25136420

  14. A study on the evaluation method and recent clinical efficacy of bevacizumab on the treatment of radiation cerebral necrosis

    PubMed Central

    Zhuang, Hongqing; Yuan, Xiangkun; Zheng, Yi; Li, Xubin; Chang, Joe Y.; Wang, Junjie; Wang, Xiaoguang; Yuan, Zhiyong; Wang, Ping

    2016-01-01

    In order to investigate the efficacy of bevacizumab on the treatment of radiation cerebral necrosis, patients who were diagnosed with radiation cerebral necrosis by imaging after stereotactic radiotherapy were collected. Bevacizumab was applied at a dose of 5 mg/kg once every three weeks at least three times. The changes in cerebral necrosis symptoms before and after treatment, the cerebral edema volume, the cerebral necrosis volume, and the changes in magnetic resonance imaging (MRI) strengthening phase signals of cerebral necrosis were used as the first observation point. The side effects of bevacizumab were used as the second observation point. Total of 14 radiation cerebral necrosis patients were treated with bevacizumab between June 2011 and February 2013 were collected. There were 12 symptomatic patients, of whom 10 patients (83.3%) had reduced symptoms. The edema index grades of nine patients (64.29%) improved. The cerebral necrosis volumes of 13 patients (92.86%) decreased. The T1 phase signal strengths of the intracranial enhanced MRIs of 12 patients (85.71%) significantly decreased. The clinical side effects of bevacizumab were mild. In conclusion, Preliminary results showed that treatment of radiation cerebral necrosis using bevacizumab was safe and effective. This treatment measure is worthy of further study. PMID:27067388

  15. 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

  16. Clinical evaluation of desoximetasone in treatment of dermatoses and psoriasis.

    PubMed

    Nair, B K; Nair, C H

    1975-05-01

    A comparative clinical evaluation of desoximetasone, a corticosterone derivative by a double blind study showed that desoximetasone has potent topical activity as effective as betamethasone valerate and probably more effective than triamcinolone acetonide. PMID:1093984

  17. Early Radiographic and Clinical Outcomes Study Evaluating an Integrated Screw and Interbody Spacer for One- and Two-Level ACDF

    PubMed Central

    Lane, Paul D.; Cox, Jacob L.; Gaskins, Roger B.; Billys, James B.; Castellvi, Antonio E.

    2015-01-01

    Background Multiple techniques and implants can be used in ACDF, the newest of which are integrated cage and screw constructs. These devices may be beneficial over anterior plate constructs due to a negligible anterior profile that may reduce dysphagia. The goal of this study is to review the early radiographical and clinical results associated with a low profile integrated intervertebral cage in one- and two-level anterior column fusions. Methods Fusion rates, incidence of hardware failure and deformity correction were assessed through 1 year. Patientreported scores, including VAS for neck pain, and improvements in axial neck pain and neurologic deficit from the preoperative baseline were quantified at 3, 6 and 12 months post-operatively. The incidence of dysphagia was recorded. Results Lordosis and disc space height at the operated levels increased an average of 4.5° and 3.3mm after device placement (p<0.001). Sagittal plane correction was maintained at 1 year. VAS improved from an average of 5.1 preoperatively to 3.1 immediately postoperatively and was maintained at 12 months. At 3 months, patient-reported improvements in axial neck pain and neurologic deficit were 85% and 93%, respectively. Reported improvements were sustained for both parameters at 12 months (77% and 86%, respectively). Fusion was noted in 93% of the operated levels. There were two documented cases of dysphagia that lasted more than 5 weeks, both following two level ACDFs with the test device (3.5% rate of chronic dysphagia). Conclusions The low profile integrated device improved lordosis at the operated level that was maintained at 1 year. Fusion rates with the new device are consistent with ACDF using anterior plating. In combination with improvements in pain and a minimal rate of dysphagia, study findings support the use of integrated interbody spacers for use in one- and two-level ACDF procedures. Level of Evidence Level IV, Case Series. PMID:26273557

  18. 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

  19. Evaluation of potassium binoxalate gel and Nd:YAG laser in the management of dentinal hypersensitivity: a split-mouth clinical and ESEM study.

    PubMed

    Talesara, Kamlesh; Kulloli, Anita; Shetty, Sharath; Kathariya, Rahul

    2014-01-01

    Dentinal hypersensitivity is one of the oldest recorded complaints of discomfort to mankind and yet there appears to be no permanent treatment for this clinical condition. This study was designed to evaluate the clinical efficacy of potassium binoxalate gel and neodymium:yttrium-aluminum-garnet (Nd:YAG) laser on dentin hypersensitivity for a period of 9 months. Eighty teeth (20 subjects, 25-55 years old, M = F) were evaluated in a split-mouth design to receive potassium binoxalate (group A, 40 teeth) and Nd:YAG (group B, 40 teeth: 1 W, 10 Hz, and 60 s, irradiated twice). The diameter of output beam was about 300 μm with a distance of 2 mm between laser fiber or tip and tooth surface. The clinical efficacy was evaluated by air-blast test and cold-water test using visual analog scale. Electron microscopy photomicrographs were taken to confirm the results. Analysis was done at baseline; immediately post-treatment; and at 3, 6, 9 months post-treatment. Student's paired and unpaired T tests were used to evaluate the statistical analysis. Both treatment modalities were effective in reducing dentine hypersensitivity. However, Nd:YAG laser was better when intragroup comparison was made at 9 months post-treatment. Nd:YAG lasers is better in long-term treatment (up to 9 months) owing to the melting of dentinal tubules. However, due to depth of penetration of microcrystals, gel was better when ease of the procedure is considered. Nevertheless, both treatment modalities resulted in recurrence. Hence, further studies are needed to discover an agent, which can be considered as a "gold standard". PMID:23184419

  20. Evaluating sanitization of toothbrushes using ultra violet rays and 0.2% chlorhexidine solution: A comparative clinical study

    PubMed Central

    Tomar, Poonam; Hongal, Sudheer; Saxena, Vrinda; Jain, Manish; Rana, Kuldeep; Ganavadiya, Rahul

    2014-01-01

    Background: Toothbrushes may play a significant role in plaque control. Toothbrushes should be correctly stored, disinfected and changed at regular intervals. Objective: The purpose of this study was to evaluate the efficacy of 0.2% chlorhexidine (CHX) gluconate solution and ultra violet (UV) toothbrush-sanitizer for toothbrush disinfection. Materials and Methods: Fresh tooth brushes were distributed to fifteen study subjects, who were selected randomly and who met the study criteria. All the study participants were asked to brush their teeth with the tooth brush provided. No special instructions were given regarding the brushing techniques. Toothbrushes were collected after 7 days. All tooth brushes were randomly allocated to three groups. Tooth brushes were subjected to microbial analysis and total bacterial count was assessed. Tooth brushes allocated to Group I were soaked in 2% CHX mouthwash for 12 h, Group II were kept in UV-light toothbrush holder for 7 min, and Group III were soaked in normal saline for 12 h. All the toothbrushes were subjected for microbial analysis and mean bacterial count was determined. Results: There was a statistically significant difference between mean colony-forming unit count pre-sanitization and post-sanitization in all the groups, using 0.2% CHX gluconate, UV rays and normal saline (P < 0.007). However, the mean bacterial count reduced drastically after the treatment with UV rays (P = 0.001). Conclusions: CHX, UV rays and normal saline are effective in a reduction of bacterial count on toothbrushes. UV rays treatment was more effective, when compared to CHX and normal saline. PMID:25538466

  1. [Total amalgam reconstruction. Clinical evaluation after three years].

    PubMed

    Pivetta, G; Pivetta, E

    1989-03-15

    This study reports the results of the evaluation after three years of total amalgam restorations, made on molars and premolars vital and devitalized. The clinical parameters examinated were: 1) anatomic form and axial contour 2) marginal integrity 3) recurrent caries 4) occlusal contacts 5) interproximal contacts 6) pulpar or periodontal complication. To each of these parameters was given a degree of judgement expressed by Alpha, Bravo, Charlie, Delta. Alpha is the best evaluation, Bravo expresses a lower degree but clinically acceptable, Charlie and Delta are worse. Considering for each parameter the sum of the evaluations Alpha + Bravo, the clinically acceptable rate per cent of results has been quite good. PMID:2636172

  2. 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

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

    PubMed Central

    2013-01-01

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

  4. Clinical and biomechanical evaluation of three bioscaffold augmentation devices used for superficial digital flexor tenorrhaphy in donkeys (Equus asinus): An experimental study

    PubMed Central

    El-Shafaey, El-Sayed A.; Karrouf, Gamal I.; Zaghloul, Adel E.

    2012-01-01

    The present study was designed to carry out an in vivo and in vitro comparative evaluation of three bio-scaffold augmentation devices used for superficial digital flexor tenorrhaphy in donkeys. Twenty-four clinically healthy donkeys were assigned for three treatment trials (n = 8) using one of three bioscaffold materials (glycerolized bovine pericardium xenograft, tendon allograft and allograft with glycerolized by bovine pericardium). In addition, eight clinically healthy donkeys were selected to serve as control. Clinical signs of each animal were scored and the sum of all clinical indexes was calculated at each time point of the experiment. Four donkeys from each group were euthanized at 45 and 90 days postoperatively, respectively, for biomechanical and histopathological evaluation of treated superficial digital flexor tendon (SDFT). The failure stress in allograft shielding group significantly increased compared to the corresponding values of the other groups at 45 (62.7 ± 6.5 N mm−2) and 90 (88.8 ± 3.5 N mm−2) days postoperatively. The fetlock angle in the allograft shielding group at both 45 (112.8° ± 4.4) and 90 (123.8° ± 1.1) days postoperatively showed a significant increase (p < 0.05) relative to the values of the other groups and a significant decrease (p < 0.05) when compared to normal angle (125° ± 0). However, the histomorphological findings revealed no remarkable changes between the treatment groups. In conclusion, the failure stress, fetlock angle and histomorphological findings may provide useful information about the healing characteristics of SDFT tenorrhaphy. The bio-scaffold augmentation devices, either xenogenic or allogenic, provide good alternative techniques accelerating SDFT healing with minimal adhesions in donkeys. PMID:25685407

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

    PubMed Central

    Deshpande, Neeraj C.; Bhat, K. M.; Bhat, G. S.; Deshpande, Anshula N.

    2013-01-01

    Background: This randomized, controlled clinical study was planned to evaluate the use of anti-inflammatory drug flurbiprofen in the form of locally delivered controlled release gel in the treatment of periodontal disease. Materials and Methods: The flurbiprofen gel was indigenously prepared in the concentration of 0.3%. The 30 patients with localized periodontal pockets measuring ≥5 mm were randomly divided into three groups. The groups received flurbiprofen gel, flurbiprofen gel after prophylaxis, and placebo gel after oral prophylaxis, respectively. The clinical parameters for plaque and gingival inflammation were evaluated at baseline, 7th day, and 14th day. Results: The results of the study suggested the statistically significant (P < 0.05) improvement in the gingival status of the patients with the use of flurbiprofen gel as an adjunct to scaling and root planing as compared to oral prophylaxis or gel alone. Conclusion: The data demonstrated that the additional use of local drug delivery of flurbiprofen through gel media enhances the positive effects of scaling and root planing and helps in faster resolution of the inflammation. PMID:23853449

  6. 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. PMID:21887500

  7. 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

  8. Interprofessional student clinics: an economic evaluation of collaborative clinical placement education.

    PubMed

    Haines, Terry P; Kent, Fiona; Keating, Jennifer L

    2014-07-01

    Interprofessional student clinics can be used to create clinical education placements for health professional students in addition to traditional hospital-based placements and present an opportunity to provide interprofessional learning experiences in a clinical context. To date, little consideration has been given in research literature as to whether such clinics are economically viable for a university to run. We conducted an economic evaluation based upon data generated during a pilot of an interprofessional student clinic based in Australia. Cost-minimization analyses of the student clinic as opposed to traditional profession-specific clinical education in hospitals were conducted from university, Commonwealth Government, state government and societal perspectives. Cost data gathered during the pilot study and market prices were used where available, while $AUD currency at 2011 values were used. Per student day of clinical education, the student clinic cost an additional $289, whereas the state government saved $49 and the Commonwealth Government saved $66. Overall, society paid an additional $175 per student day of clinical education using the student clinic as opposed to conventional hospital-based placements, indicating that traditional hospital-based placements are a cost-minimizing approach overall for providing clinical education. Although interprofessional student clinics have reported positive patient and student learning outcomes, further research is required to determine if these benefits can justify the additional cost of this model of education. Considerations for clinic sustainability are proposed. PMID:24417539

  9. Comparative evaluation of free gingival graft and AlloDerm® in enhancing the width of attached gingival: A clinical study

    PubMed Central

    Agarwal, Chitra; Tarun Kumar, A. B.; Mehta, Dhoom Singh

    2015-01-01

    Background: The presence of an adequate width of keratinized tissue is important to maintain a healthy dentogingival junction. In case of inadequate width of attached gingiva, the gingival augmentation procedure has been performed classically using the patient's own masticatory mucosa and more recently, using an acellular dermal allograft as the donor material. Aims: The aim of the clinical study was to evaluate and compare the effectiveness of free gingival graft (FGG) and acellular dermal matrix (ADM) allograft in the ability to increase the zone of attached gingiva. Materials and Methods: Fifteen patients with 30 sites showing the inadequate width of attached gingiva (≤1 mm) were enrolled for the split-mouth study. The width of keratinized gingiva and other clinical parameters were recorded at baseline and 12th month postoperatively. Statistical Analysis: The difference in clinical parameters within the group was assessed by Wilcoxon signed rank test. However, Mann–Whitney U-test was used to analyze the differences between test and control groups. Results: The width of attached gingiva increased significantly (P < 0.01) following both the treatments but comparatively lesser gain with ADM allograft (2.13 mm vs. 4.8 mm). ADM site had significantly more shrinkage (76.6%) than FGG site (49.7%). Though FGG was found to be more effective, clinicians can prefer ADM allograft because of its certain advantages over the FGG. Conclusion: ADM allograft has resulted in sufficient increase in width of attached gingiva although lesser than FGG. Considering the disadvantages of FGG, it can be concluded that ADM allograft can be used as an alternative to FGG in increasing width of attached gingival in certain clinical situations. PMID:26681852

  10. 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

  11. 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)

  12. Understanding clinical nursing education: An exploratory study.

    PubMed

    Dahlke, Sherry; O'Connor, Maureen; Hannesson, Teresa; Cheetham, Karleen

    2016-03-01

    Clinical experiences are recognized as a critical aspect of nursing education, highlighting the importance of the perspectives of those providing clinical instruction. The aim of this mixed methods descriptive study was to discover the knowledge and guidance needs of preceptors and clinical faculty who provide clinical instruction to Bachelor of Science in Nursing (BSN) students. Fifteen clinical faculty and 17 preceptors were surveyed using a questionnaire developed and piloted by the researchers. Although preceptors and clinical faculty reported a high level of knowledge and confidence in their ability to guide student nurses, they also identified the need for additional support for their teaching roles. Analysis of the qualitative data provided insights into what helped and what hindered clinical instruction, as well as what could enhance clinical instruction. The development, implementation, and evaluation of formal education and mentorship processes for preceptors and clinical faculty are recommended in order to meet these knowledge and guidance gaps. Further research is also needed to explore how to clinical instruction could be tailored to the capacity of those engaged in the experiences and to clinical environments. PMID:26775165

  13. 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

  14. 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

    Shetty, Ranjan; 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

  15. 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

  16. [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

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

    PubMed Central

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

    2015-01-01

    Summary 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. PMID:26668556

  18. 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. PMID:26668556

  19. Evaluation of canine retraction following periodontal distraction using NiTi coil spring and implants – A clinical study

    PubMed Central

    Khanna, Rohit; Tikku, Tripti; Sachan, Kiran; Maurya, R.P.; Verma, Geeta; Ojha, Vivek

    2014-01-01

    Objective To evaluate the amount of canine retraction with periodontal distraction using miniscrew implants and NiTi coil spring. Material and method Sample comprised of 25 patients who were scheduled for all 1st premolar extraction (13 males and 12 females), in the age range of 16–22 years with mean age 18.8 ± 2.7 years. For each patient left side served as control side (Group I) and right side as experimental side (Group II). At the time of first premolar extraction, periodontal distraction was performed only on the experimental side, followed by retraction of canine from mini-implant by closed NiTi coil spring on both the sides. “Nemotech” software was used to evaluate the amount of canine retraction for a period of 3 months. Results Significantly higher amount of tooth movement was seen from T0–T1 and from T1–T2 in Group II for the maxillary parameters 3C-5C, 6CF-3C, 3C-I/3C-J and for the mandibular parameter 6CF″-3C″. Whereas no significant amount of tooth movement was observed for maxillary and mandibular parameters between T2-T3 except for 6CF″-3C″ (p ≤ 0.01) which was significantly higher for the Group II. Conclusion There was accelerated canine retraction on the periodontal distraction side as compared to the control side, with negligible anchorage loss. PMID:25737943

  20. 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. PMID:23664251

  1. [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. PMID:26545328

  2. Clinical evaluation of diphenhydramine hydrochloride for the treatment of insomnia in psychiatric patients: a double-blind study.

    PubMed

    Kudo, Y; Kurihara, M

    1990-11-01

    The usefulness of the antihistaminic agent diphenhydramine hydrochloride was evaluated using a double-blind procedure at sleeping doses of 12.5, 25, and 50 mg in 144 psychiatric patients with insomnia. The general condition of the patients with insomnia was at least "slightly improved" in 62.5% (12.5-mg group), 60% (25-mg group), and 67.4% (50-mg group) after treatment with the test drug for 2 weeks. Side effects were observed in a total of 11 patients (7.6%) but were not severe. No symptoms suggestive of drug dependence were evident. Global improvement was not influenced by patient background factors except for the presence or absence of previous treatment for insomnia. The hypnotic effect of diphenhydramine hydrochloride was significantly greater in patients who had not been treated previously. A dose-dependent increase in the hypnotic effect was also seen in patients who had not received any previous treatment. Diphenhydramine hydrochloride thus appears to be effective in the treatment of insomnia, but the appropriate dosage will depend on previous medical treatment of insomnia. PMID:2243152

  3. [Comparative evaluation of antiplatelet efectiveness drugs of original and reproduced enteric forms of acetylsalicylic acid (clinical study ICAR))].

    PubMed

    Martsevich, S Iu; Tolpygina, S N; Lukina, Iu V; Voronina, V P; Kiseleva, N V; Boĭchenko, E S; Dubinskaia, R É; Khoseva, E N

    2012-01-01

    The purpose of the study was a comparative study of antiplatelet activity of acetylsalicylic acid drugs, produced in gastro-resistant form trombopol 75 mg and aspirin cardio 100 mg in patients with high risk of cardiovascular events. Effect of trombopol 75 mg versus 100 mg aspirin cardio on platelet aggregation in 30 patients with high risk of cardiovascular events during 3 week treatment period was studied. Design method: blind, randomized, crossover method. Three weeks before the initial therapy, for those patients, who received antiplatelet platelet therapy at the time of inclusion in the study, this therapy was withdrew ("wash-out period"), after which patient was given one of the study drug (sequence of courses was s determined according to the scheme of randomization) with the recommendation of taking it daily in the morning at the same time. At each visit, before the next dose of the drug, blood samples for determination of ADP-induced platelet aggregation were taken, physical examination, measurement of blood pressure (BP) and heart rate were recorded, adverse events were recorded. Follow-up visit was performed 3 weeks later. 21 days after first study drug withdrawal, a second similar course of therapy with another drug was performed. Antiplatelet efficacy of aspirin was assessed by its effect on spontaneous and ADP- induced platelet aggregation. Aggregation activity was determined by turbidometric method by changing of translucent ability of the blood sample during the formation of aggregates after 2 minutes of exposure. As an inducer of aggregation ADP solutions of three concentrations (0.5, 1 and 2 mM) were used. No significant difference between compared drugs in influence on aggregation ability of platelets after 3 weeks of daily intake was found. No adverse events associated with taking of studied drugs were registered. It was concluded that, generic APD - trombopol 75 mg and aspirin cardio 100 mg were equivalent on antiplatelet efficacy and

  4. 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

  5. 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

  6. OA01.40. A clinical study to evaluate the efficacy of leech therapy and panchatikta ghrita in the management of psoriasis)

    PubMed Central

    Gond, Pushpa; Rani, Rekha; Shringi, M. K.

    2012-01-01

    Purpose: Modern medical science treats psoriasis with PUVA, corticosteroid, anti-mitotic drugs which gives serious side effects like liver and kindney failure etc. There is a need to discover safe and effective medicine without any side effects for Psoriasis and the role of Leech Therapy (Shodhan) and Panchatikta Ghrita (Shaman Karma) is evaluated in this study. Method: 30 patients were included who matched the clinical signs and symptoms of psoriasis. These patients were randomised into three groups. Group A Only on leech therapy, Group B-Only on panchatikta ghrita and Group C On both leech therapy and panchatikta ghrita Result: Group A showed 45% improvement and group B showed 47% improvement, while group C reported 65% improvement. Conclusion: It can be concluded that shodan(leech application) along with shaman (panchatikta ghrita) is effective in the management of psoriasis as it is safe, cost effective and free from any side effects.

  7. 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

  8. [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. PMID:2147884

  9. Efficacy of sealing proximal early active lesions: an 18-month clinical study evaluated by conventional and subtraction radiography.

    PubMed

    Martignon, S; Ekstrand, K R; Ellwood, R

    2006-01-01

    This study assessed the efficacy of sealing proximal lesions on adult patients using a split-mouth design. Eighty-two 15- to 39-year-olds from the Dental Faculties in Copenhagen and Bogotá participated, each having 2 or more proximal lesions in the following radiographic stages: (1) lesion restricted to the outer half of enamel; (2) lesion from the inner half of enamel including the enamel dentine junction, and (3) lesion restricted to the outer third of dentine. Standardized geometrically aligned baseline and follow-up radiographs were obtained. One randomly selected lesion (test) in each patient was sealed with 1 of 2 resins. The patients were instructed to floss all the proximal lesions 3 times per week. The baseline to 18 months difference in caries lesion progression status was assessed using 3 methods: (1) radiographs were independently assessed visually; (2) radiographs were read in pairs, and (3) using subtraction radiography of digitized images. A total of 72 subjects finished the study (12.2% dropout). The compliance concerning flossing was poor (15%). For the repeated examinations kappa was 0.84 for the visual examination, 0.44 for the paired readings and 0.84 for the subtraction examination. Two test lesions and 1 control lesion were restored. For the independent radiograph assessment method 10 and 26% progressed in the test and control group, respectively (p > 0.05); with the paired radiograph method the corresponding data were 22% in the test and 47% in the control groups (p < 0.01). By subtraction radiography 44% of the test group and 84% of the control were judged to have progressed (p < 0.001). The sealing technique was superior to instructing patients to floss, and subtraction radiography appeared to be the most sensitive method for assessing lesion progression. PMID:16946605

  10. Evaluating steroidal contraceptives: pre-clinical and clinical approaches.

    PubMed

    Berry, C L

    1988-05-01

    The Special Program of Research, Development and Research Training in Human Reproduction of the World Health Organization held a meeting in Geneva in February of 1987 to review the results of animal and human studies analyzing contraceptive steroids. In reviewing this data, assessment of pre-clinical toxicology and human risk would be possible. The studies reviewed included: studies on steroid exposure and breast disease, the protective factor of combined oral contraceptives (OC) (against ovarian cancer), hormonal contraceptives and cervical cancer, the relationship of gall bladder disease to OC use, congenital malformations and steroid hormone, OC use and its effect on breast milk and other topics. Basic principles on pre-clinical testing were adopted. These included: 1) the establishment of safety is a joint responsibility of experimental toxicology and clinical pharmacology. 2) Testing should include detailed analysis of the hormonal effect of new types in several animal species. 3) Species specific data should be collected. 4) Studies to detect cumulative toxicity should be performed. 5) Reproductive toxicity should concentrate on exposure throughout the embryonic period. 6) In vivo and in vitro tests should be conducted to investigate the mutagenic potential of new contraceptive steroids. 7) Long-term carcinogenicity study should be performed, preferably on the rat. 8) When new delivery systems are used to administer established steroidal contraceptives, experimental safety studies should assess potential interactions with the system and on the possibility of adverse effects of the delivery system. 9) Post-registration surveillance is on integral part of the risk assessment process. PMID:3391619

  11. Clinical Evaluation of Benign Prostatic Hyperplasia

    PubMed Central

    McVary, Kevin T

    2003-01-01

    Benign prostatic hyperplasia (BPH) is the most common neoplastic condition afflicting men and constitutes a major factor impacting male health. Clinical evaluation to assess the presence and degree of voiding dysfunction and/or the role of BPH in its presence has an increasingly broad spectrum of treatment goals. The goals of the evaluation of such men are to identify the patient’s voiding or, more appropriately, urinary tract problems, both symptomatic and physiologic; to establish the etiologic role of BPH in these problems; to evaluate the necessity for and probability of success and risks of various therapeutic approaches; and to present the results of these assessments to the patient so he can make an informed decision about management recommendations and available alternatives. PMID:16985961

  12. Clinical Evaluation of Benign Prostatic Hyperplasia

    PubMed Central

    McVary, Kevin T

    2003-01-01

    Benign prostatic hyperplasia (BPH) is the most common neoplastic condition afflicting men and constitutes a major factor impacting male health. Clinical evaluation to assess the presence and degree of voiding dysfunction and/or the role of BPH in its presence has an increasingly broad spectrum of treatment goals. The goals of the evaluation of such men are to identify the patient’s voiding or, more appropriately, urinary tract problems, both symptomatic and physiologic; to establish the etiologic role of BPH in these problems; to evaluate the necessity for and probability of success and risks of various therapeutic approaches; and to present the results of these assessments to the patient so he can make an informed decision about management recommendations and available alternatives. PMID:16985968

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

    PubMed Central

    2010-01-01

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

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

    PubMed

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

    2014-12-01

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

  15. 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

  16. 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. PMID:27190635

  17. 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

  18. 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

  19. 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. PMID:25684129

  20. 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.

  1. Clinical evaluation of teicoplanin fluorescence polarization immunoassay.

    PubMed Central

    Rybak, M J; Bailey, E M; Reddy, V N

    1991-01-01

    A teicoplanin fluorescence polarization immunoassay (FPIA) developed by International BioClinical (IBC) was evaluated by using serum samples from patients who had been receiving teicoplanin at Detroit Receiving Hospital (DRH) as part of a clinical investigation. Patient samples collected over a 1-year span were assayed at DRH and at IBC, and the results were compared with those of a standard microbiological assay performed at Merrell Dow Research Institute, Indianapolis, Ind. The FPIA has a rapid turnaround time (circa 20 min), utilizes small sample volumes (less than 100 microliters) and is sensitive and accurate in determining concentrations in the range of 5 to 100 micrograms/ml. The intra-assay and interassay coefficient of variation for controls (7, 35, and 75 micrograms/ml) was less than or equal to 13%. Concentrations greater than 100 micrograms/ml must be diluted prior to the assay, which may introduce additional error in determination. The FPIA compared well with the bioassay (r = 0.901) for 193 clinical samples. The results obtained utilizing the FPIA system were reproducible at two different sites, as illustrated by the high degree of correlation between the results at DRH and IBC (r = 0.92). There was less than 7% interference noted when teicoplanin was assayed in the presence of other antibiotics. Patient samples stored for up to 1 year retained their potency: the mean recovery rate in these samples was 107%. The FPIA should be useful for monitoring and adjusting teicoplanin dosage regimens in patients. PMID:1834014

  2. 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

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

    PubMed

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

    2009-10-01

    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

  4. 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)…

  5. 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.

  6. 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

  7. Clinical evaluation of implant survival based on size and site of placement: A retrospective study of immediate implants at single rooted teeth sites

    PubMed Central

    Ramalingam, Sundar; Al-Hindi, Maryam; Al-Eid, Raniah Abdullah; Nooh, Nasser

    2015-01-01

    Objectives This retrospective clinical study sought to evaluate the survival of immediate implants placed at maxillary and mandibular single-rooted tooth extraction sites and to determine the relationship among implant size, placement site, and implant survival. Methods Between January 2010 and June 2011, 85 patients (33 males, 52 females; mean age: 45 years) underwent immediate implant placement after extraction of single-rooted teeth. All implants were restored between 12 and 14 weeks after implant placement. The implant survival and its relationship with implant size and implantation site were evaluated by odds ratios (ORs). Results Implants were placed at the following sites: upper central incisor (UCI, n = 35), upper lateral incisor (ULI, n = 27), upper second premolar (U2ndP, n = 36), lower incisor (LI, n = 53), and lower premolar (LP, n = 22). Implants of the following sizes were used: 5 × 10 mm (n = 24), 5 × 8 mm (n = 21), 4.3 × 10 mm (n = 77), 4.3 × 8 mm (n = 36), 3.5 × 10 mm (n = 12), and 3.5 × 8 mm (n = 3). After a mean follow-up time of 47 months, the overall implant survival rate was 96%. Survival rate was highest at the LI site (98.1%) and lowest at the ULI site (92.6%). All of the 5-mm implants survived (100%), as did most of the 4.3 × 10 mm implants (96.1%). Implants of 4.3 × 8 mm and 3.5 × 10 mm were the least successful (91.7%). Mandibular implants had a better survival rate (97.3%) than maxillary implants (94.9%). There was no significant OR of increased survival for any particular implant size or site. Conclusions Immediate implant placement in fresh extraction sockets can give predictable clinical outcomes, regardless of the implant size and site of placement. PMID:26082578

  8. Expanded clinical evaluation of lovastatin (EXCEL) study results: III. Efficacy in modifying lipoproteins and implications for managing patients with moderate hypercholesterolemia.

    PubMed

    Bradford, R H; Shear, C L; Chremos, A N; Franklin, F A; Nash, D T; Hurley, D P; Dujovne, C A; Pool, J L; Schnaper, H; Hesney, M

    1991-07-31

    In the multicenter, double-blind EXCEL (Expanded Clinical Evaluation of Lovastatin) study the efficacy of lovastatin in modifying plasma lipids and lipoproteins in 8,245 participants with moderate primary hypercholesterolemia was evaluated. Patients were randomly assigned to 48 weeks of treatment with diet and placebo or diet and lovastatin 20 or 40 mg once a day, or 20 or 40 mg twice a day. At all of these dosages, lovastatin produced substantial dose-dependent reductions in low-density-lipoprotein (LDL)-cholesterol levels, averaging 24% (20 mg/day) to 40% (80 mg/day). The magnitude of the effect of this lipoprotein was further reflected by the percentage of patients who achieved National Cholesterol Education Program (NCEP) goals. In the absence of coronary artery disease (CAD) or two other CAD risk factors, the LDL-cholesterol goal of 4.14 mmol/L (160 mg/dL) was attained by 22% of patients in the placebo group and between 81% (20 mg/day) and 96% (80 mg/day) of those treated with lovastatin. For those with CAD or at least two other CAD risk factors, the LDL-cholesterol goal of 3.36 mmol/L (130 mg/dL) was attained by 4% of placebo patients and between 38% (20 mg/day) and 83% (80 mg/day) of those treated with lovastatin. Lovastatin also increased high-density-lipoprotein cholesterol (7-10%) and decreased triglycerides (10-19%) in a dose-dependent manner. Thus, when used as an adjunct to a prudent diet, lovastatin produces favorable changes in the entire lipoprotein profile and is a highly effective agent for managing patients with primary hypercholesterolemia. PMID:1867232

  9. 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

  10. Clinical breast evaluation skills of house officers and students.

    PubMed

    Chalabian, J; Garman, K; Wallace, P; Dunnington, G

    1996-10-01

    Current health care reform is placing primary care physicians in an increasingly significant role as the front-line providers of women's health care. It is critical that primary care physicians as well as surgeons develop the knowledge base, physical examination skills, and interpersonal skills necessary to care for patients with breast cancer. This study uses a standardized patient breast case in an Objective Structured Clinical Examination (OSCE) format to objectively assess clinical breast evaluation skill performance by house officers and medical students. Performance of USC medical students, exposed to a uniform clinical breast evaluation curriculum, were compared with MSIVs from four other medical schools, and postgraduate year I and II categorical surgical residents. USC medical students were found to maintain performance between an initial surgical OSCE breast station and a delayed clinical practice exam (CPX) reexam as MSIVs (breast exam, P = 0.21; patient-physician interaction, P = 0.67). USC MSIVs had statistically significantly higher performance on the CPX breast station when compared with other MSIVs (T = 11.701, two-tailed test, P = 0.0001). House officers demonstrated significantly poorer skills than medical students (P = 0.03). An incoming housestaff group showed improvement with clinical breast evaluation checklists and orientation as part of their intern orientation program and ongoing curriculum. PMID:8813167

  11. Comparative evaluation of envelope type of advanced flap with and without type I collagen membrane (NEOMEM™) in the treatment of multiple buccal gingival recession defects: A clinical study

    PubMed Central

    Gupta, Priyanka; Gupta, Harinder

    2014-01-01

    Background: The aim of this study is to compare and evaluate the clinical outcome of the envelope-type of coronally advanced flap (CAF) alone versus envelope type of coronally advanced flap plus type I collagen membrane (NEOMEM) in the treatment of multiple buccal gingival recessions, using the split mouth study. Materials and Methods: Ten patients in the age group of 20-50 years showing bilateral gingival recessions were treated. The defects in each patient were randomly assigned as Group A, which were treated with the envelope type of CAF, and those in Group B were treated with envelope type of CAF along with the Type I collagen membrane (NEOMEM). The recession depth (RD), probing depth (PD), clinical attachment level (CAL), and width of the keratinized tissue (KT) were measured at baseline, at three and six month intervals. Results: Forty-six Miller's class I and II gingival recessions were treated. In the CAF + Type I collagen membrane (NEOMEM)-treated (Group B) sites the baseline gingival recession was 2.34 ± 0.48 mm, while in the CAFtreated (Group A) sites it was 2.52 ± 0.84 mm. Both the treatments resulted in significant recession depth reduction (P < 0.001), but the reduction was significantly greater (P < 0.01) for Group B than Group A. The probing depth changes were significant (P < 0.01) for both groups, but the difference was nonsignificant. Similarly, a significant gain of CAL was seen in Group B (2.23 ± 0.75 mm, P < 0.001) as well as in group A (1.60 ± 0.86 mm, P < 0.001) showing a significant difference (P < 0.01) between the two groups. The width of keratinized tissue was also significantly (P < 0.001) increased in both groups, but the increase was significantly greater (P < 0.001) in group B (2.30 ± 1.06 mm) than in group A (1.21 ± 0.67 mm). Conclusion: The envelope type of CAF along with Type I collagen membrane (NEOMEM) was more effective than envelope type of CAF alone, in producing root coverage in multiple gingival recession defects

  12. [Assessment of clinical practice guidelines evaluation. Scales and criteria].

    PubMed

    Rico Iturrioz, Rosa; Gutiérrez-Ibarluzea, Iñaki; Asua Batarrita, José; Navarro Puerto, Maria Asunción; Reyes Domínguez, Antonio; Marín León, Ignacio; Briones Pérez de la Blanca, Eduardo

    2004-01-01

    Not only are there large number of guides, protocols and other support tools available for the clinical decision-making process in the Spanish National Health System, but there is also a major degree of variability among them, reflecting inconsistencies and low quality of those documents. This study is aimed at conducting all inventory of the Clinical Practice Guideline assessment scales and clinical analysis tools and to propose a scale or set of criteria for assessing the quality of the Clinical Practice Guidelines put out in Spain. A systematic search of critical evaluation scales was conducted. The inclusion criteria and the concordance analysis of the items by three evaluators were independently applied. The discordances were resolved by explicit consensus. Ten suggested critical assessment scales and sets of criteria from eleven institutions were identified, eight of which consist of scales and tools proposed for assessing the quality of the Clinical Practice Guidelines, the other two being proposals for assessing the implementation and inclusion of the Clinical Practice Guidelines in a register. In the comparative analysis, the criteria most often repeated on the scales analysed were related to the areas included in the AGREE Instrument. The areas considered in most of the critical assessment scales were the same as those of the AGREE Instrument. Although this tool does not take in criteria for guide implementation assessment purposes, it is considered suitable for use in the assessment prior to inclusion to the national CPG register. PMID:15384260

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

    PubMed Central

    Babu, Harsha Mysore; Gujjari, Sheela Kumar; Prasad, Deepak; Sehgal, Praveen Kumar; Srinivasan, Aishwarya

    2011-01-01

    Background: Gingival recession (GR) can result in root sensitivity, esthetic concern to the patient, and predilection to root caries. The purpose of this randomized clinical study was to evaluate (1) the effect of guided tissue regeneration (GTR) procedure using a bioabsorbable collagen membrane, in comparison to autogenous subepithelial connective tissue graft (SCTG) for root coverage in localized gingival recession defects; and (2) the change in width of keratinized gingiva following these two procedures. Materials and Methods: A total of 10 cases, showing at least two localized Miller's Class I or Class II gingival recession, participated in this study. In a split mouth design, the pairs of defects were randomly assigned for treatment with either SCTG (SCTG Group) or GTR-based collagen membrane (GTRC Group). Both the grafts were covered with coronally advanced flap. Recession depth (RD), recession width (RW), width of keratinized gingiva (KG), probing depth (PD), relative attachment level (RAL), plaque index (PI), and gingival index (GI) were recorded at baseline, 3 and 6 months postoperatively. Results: Six months following root coverage procedures, the mean root coverage was found to be 84.84% ± 16.81% and 84.0% ± 15.19% in SCTG Group and GTRC Group, respectively. The mean keratinized gingival width increase was 1.50 ± 0.70 mm and 2.30 ± 0.67 mm in the SCTG and GTRC group, respectively, which was not statistically significant. Conclusion: It may be concluded that resorbable collagen membrane can be a reliable alternative to autogenous connective tissue graft in the treatment of gingival recession. PMID:22368359

  14. Malignancies in transplanted patients: Multidisciplinary evaluation and switch to mTOR inhibitors after kidney transplantation - experiences from a prospective, clinical, observational study.

    PubMed

    Hellström, Vivan C; Enström, Ylva; von Zur-Mühlen, Bengt; Hagberg, Hans; Laurell, Anna; Nyberg, Filippa; Bäckman, Lars; Opelz, Gerhard; Döhler, Bernd; Holmberg, Lars; Tufveson, Gunnar; Enblad, Gunilla; Lorant, Tomas

    2016-06-01

    Background Solid organ transplant recipients are at increased risk of developing malignancies. The objective of this prospective, observational, one-armed study was to study the feasibility to add a mammalian target of rapamycin (mTOR) inhibitor to the immunosuppressive regimen in transplanted patients with post-transplant malignancies. During the trial the need to improve identification of post-transplant malignancies and to reassure adequate oncological treatment of these patients became evident. Multidisciplinary team (MDT) evaluation of oncological and immunosuppressive treatments was implemented for all patients with malignancies after renal or combined renal and pancreas transplantation because of the trial. Material and methods At Uppsala University Hospital, Sweden, a MDT consisting of transplant surgeons, nephrologists, oncologists and dermatologists evaluated 120 renal or combined renal and pancreas-transplanted recipients diagnosed with malignancies from September 2006 to July 2012. To identify all malignancies, the population was linked to the Regional Tumor Registry (RTR). We recorded to which extent a switch to mTOR inhibitors was possible and how often the originally planned oncological managements were adjusted. All patients were followed for three years. (ClinicalTrials.gov: NCT02241564). Results In 76 of 120 patients (63%) a switch to mTOR inhibitors was possible. Immunosuppression was interrupted in seven patients (6%), reduced in three patients (2%) and remained unchanged in 34 of 120 patients (28%). Identification of post-transplant malignancies increased significantly after linkage to RTR (p = 0.015). The initially recommended oncological treatment was adjusted in 23 of 44 patients (52%) with solid or hematological malignancies; 36 of these patients (82%) were treated according to national guidelines. Conclusion In two thirds of the patients the immunosuppressive treatment could be changed to an mTOR inhibitor with anti-tumor effects in

  15. Comprehensive non-clinical respiratory evaluation of promising new drugs

    SciTech Connect

    Murphy, Dennis J. . E-mail: dennis.j.murphy@GSK.com

    2005-09-01

    The need to evaluate the potential for new drugs to produce adverse effects on respiratory function in non-clinical safety assessment is based on the known effects of drugs from a variety of pharmacological/therapeutic classes on the respiratory system, the life-threatening consequences of respiratory dysfunction, and compliance with world-wide regulatory safety guidelines. The objective of this article is to provide a brief overview of the functional disorders of the respiratory system and to present the strategy and techniques considered to be most appropriate for detecting and characterizing drug-induced respiratory disorders in non-clinical safety studies.

  16. ["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

  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. 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

  20. Healthcare-associated bloodstream infections in critically ill patients: descriptive cross-sectional database study evaluating concordance with clinical site isolates

    PubMed Central

    2014-01-01

    Background Healthcare-associated bloodstream infections are related to both increased antibiotic use and risk of adverse outcomes. An in-depth understanding of their epidemiology is essential to reduce occurrence and to improve outcomes by targeted prevention strategies. The objectives of the study were to determine the epidemiology, source and concordance of healthcare-associated bloodstream infections with clinical site isolates. Methods We conducted a descriptive cross-sectional study in critically ill adults admitted to a tertiary semi-closed intensive care unit in England to determine the epidemiology, source and concordance of healthcare-associated bloodstream infections with clinical site isolates. All nosocomial positive blood cultures over a 4-year study period were identified. Pathogens detected and concordances with clinical site are reported as proportions. Results Contaminant pathogens accounted for half of the isolates. The most common non-contaminant pathogens cultured were Pseudomonas spp. (8.0%), Enterococcus spp. (7.3%) and Escherichia coli (5.6%). Central venous catheter-linked bloodstream infections represent only 6.0% of the positive blood cultures. Excluding contaminants and central venous line infections, in only 39.5% of the bloodstream infections could a concordant clinical site source be identified, the respiratory and urinary tracts being the most common. Conclusions Clinical practice should focus on a) improving blood culture techniques to reduce detection of contaminant pathogens and b) ensuring paired clinical site cultures are performed alongside all blood cultures to better understand the epidemiology and potential implications of primary and secondary discordant health-care associated bloodstream infections. PMID:25593750

  1. 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…

  2. [Clinical practice guideline: a complete geriatric evaluation].

    PubMed

    Medina-Chávez, Juan Humberto; Torres-Arreola, Laura Del Pilar; Cortés-González, Rosa María; Durán-Gómez, Verónica; Martínez-Hernández, Fernando; Esquivel-Romero, Gustavo

    2011-01-01

    The care of elderly patients requires an evaluation that deserves a host of special considerations, such as biological aspects of aging, those related to activities of daily living and functionality, neuro-psychological conceptions, family dynamics and economic conditions. The growth of the aging population in our country is accompanied by an increase in chronic diseases and more individuals have greater vulnerability, requiring a more consumption of resources because of the high demand for services. This requires the incorporation of specialized care in the institutional system, which has caused serious consequences in the current health system, benefiting specialization and technology, but with a loss of an integrated and horizontal view of the patient. Therefore it is necessary to develop a practical tool that allows the family physician to identify and differentiate the geriatric population that requires specialized care from who does not, identifying problems that may improve and allow the design of strategies to improve health status and maintain functional autonomy of the elderly. Comprehensive Geriatric Assessment (CGA) is a fundamental tool for clinical practice of any medical care to the elderly. PMID:22176832

  3. 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…

  4. Evaluation of Clinical and Immunological Responses: A 2-Year Follow-Up Study in Children with Allergic Rhinitis due to House Dust Mite

    PubMed Central

    Moed, Heleen; Gerth van Wijk, Roy; Hendriks, Rudi W.; van der Wouden, J. C.

    2013-01-01

    Background. Allergic rhinitis is a disease with polarization towards Th2 and a defect of regulatory T cells. Immunological changes have been reported after immunotherapy treatment. However, there is not much known about the natural course of allergic rhinitis with respect to clinical manifestation and the relation with immunological responses. Objective. To evaluate clinical symptoms of allergic rhinitis, in relation to in vivo allergen-specific skin responses and in vitro allergen-specific effector and regulatory T cells determined at baseline and after two years. Methods. From a large trial, 59 children were randomly selected. The following variables were compared: clinical symptoms, allergen skin tests, specific IgE, T-cell proliferation, IL-5, IL-13, IFN-gamma, IL-10, TGF-beta, CD4+CD25hi cells, and Foxp3 expression. Results. Allergic symptoms had decreased after two years. Whereas skin test reactions correlated between years 0 and 2, there was no change in the size of the reaction. Also, proinflammatory reactions did not change after two years, with a positive correlation between years 0 and 2. No relevant changes were observed with respect to regulatory cells. Conclusion. Whereas, comparable to immunotherapy, allergic complaints decrease, the immunological changes of specific T-cell activity (both effector cells and regulator cells) which are observed after immunotherapy, do not change. PMID:23737646

  5. Liliequist membrane: radiological evaluation, clinical and therapeutic implications*

    PubMed Central

    Dias, Daniel Aguiar; Castro, Fábio Luiz Onuki; Yared, James Henrique; Lucas Júnior, Ademar; Ferreira Filho, Luiz Alves; Ferreira, Nelson Fortes Paes Diniz

    2014-01-01

    In a simplistic and succinct way, Liliequist membrane may be understood as a projection formed by an arachnoid membrane extending from the dorsum sellae to the mammillary bodies. In spite of being well known to neurosurgeons, many radiologists neither know this anatomical structure nor give importance to its study. The imaging evaluation of this membrane is feasible and may be interesting for a better preoperative planning; postoperative evaluation of third ventriculostomies; and understanding of suprasellar arachnoid cysts and perimesencephalic hemorrhage. The present article illustrates the anatomy of the membrane, with emphasis on imaging findings, besides describing its possible clinical and surgical implications. PMID:25741076

  6. Perilous periodontitis: a clinical study.

    PubMed

    Emmanuel, Roby V; Neelakantan, Shiba

    2011-12-01

    The aim of this study is to determine whether periodontitis in pregnant women could be a risk factor for pre term low birth weight. The oral hygiene status, periodontal status and periodontal treatment needs of mothers who birthed infants with normal birth weight and normal gestation period (group A) and mothers who birthed pre term low birth weight infants (group B) were assessed and compared. The clinical parameters used were Oral Hygiene Index--simplified (OHI-S), gingival bleeding index (GBI), probing pocket depth and Community Periodontal Index of Treatment Needs (CPITN). This article presents the study and its findings and draws conclusions as to the relationship between poor periodontal condition and pre term low birth weight. PMID:22216586

  7. Modeling Clinical Context: Rediscovering the Social History and Evaluating Language from the Clinic to the Wards

    PubMed Central

    Walsh, Colin; Elhadad, Noémie

    2014-01-01

    Social, behavioral, and cultural factors are clearly linked to health and disease outcomes. The medical social history is a critical evaluation of these factors performed by healthcare providers with patients in both inpatient and outpatient care settings. Physicians learn the topics covered in the social history through education and practice, but the topics discussed and documented in real-world clinical narrative have not been described at scale. This study applies large-scale automated topic modeling techniques to discover common topics discussed in social histories, to compare those topics to the medical textbook representation of those histories, and to compare topics between clinical settings to illustrate differences of clinical context on narrative content. Language modeling techniques are used to consider the extent to which inpatient and outpatient social histories share in their language use. Our findings highlight the fact that clinical context and setting are distinguishing factors for social history documentation, as the language of the hospital wards is not the same as that of the ambulatory clinic. Moreover, providers receive little feedback on the quality of their documentation beyond that needed for billing processes. The findings in this study demonstrate a number of topics described in textbooks – schooling, religion, alternative health practices, stressors, for example - do not appear in social histories in either clinical setting. PMID:25717417

  8. 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. PMID:27028840

  9. [Spondyloarthropathies--clinical evaluation and physical therapy].

    PubMed

    Vlak, Tonko

    2004-01-01

    Spondyloarthropathy is a group of chronic autoimmune disorders including ankylosing spondylitis, reactive arthritis, psoriatic arthritis, arthritis associated with inflammatory bowel disease, acute anterior uveitis and undifferentiated spondyloarthropathies. The spondyloarthropathies share common clinical, radiological, and genetic features that are clearly distinct from other inflammatory rheumatic diseases. The major goal in the management of patients with rheumatic disorders is to control or cure the disease and to preserve and control function and health status. To measure treatments' efficacy standardized assessment of organ morphology, function, and of health status are required. The instruments for measuring health status or quality of life cover a variety of dimensions of health, including physical, social, and emotional functioning. Measurements used to evaluate the efficacy of treatments in ankylosing spondylitis include spinal and chest movement, duration and severity of morning stiffness, and quality of sleep. Health status indices such as the HAQ or AIMS are not readily applicable to spondyloarthropaties. It is reason to use some others: 1. Functional status measure S-HAQ for patients with spondylitis by adding five items to the HAQ, to cover the activities identified as most problematic; 2. Functional index for the assessment of ankylosing spondylitis (Dougados Functional Index - DFI) - it is valid and reliable and shows sufficient responsiveness; S-HAQ appears at least as sensitive to change as the Dougados Index; 3. The Leeds Disability Questionnaire assesses disability in ankylosing spondylitis, inquiring about four areas of function: mobility, bending down, reaching up and neck movements, and postures; 4. The Bath Ankylosing Spondylitis Functional Index (BASFI) 10 item self-administered questionnaire to assess function and activities of daily living in patients with ankylosing spondylitis. Physical therapy is one of the most important way to

  10. Clinical application of PET for the evaluation of brain tumors

    SciTech Connect

    Coleman, R.E.; Hoffman, J.M.; Hanson, M.W.; Sostman, H.D.; Schold, S.C. )

    1991-04-01

    The combination of FDG and PET has demonstrated clinical utility in the evaluation of patients with brain tumors. At the time of diagnosis, FDG PET provides information concerning the degree of malignancy and patient prognosis. After therapy, FDG PET is able to assess persistence of tumor, determine degree of malignancy, monitor progression, differentiate recurrence from necrosis, and assess prognosis. Other studies using PET provide information that may be clinically useful. Determination of tumor blood flow and permeability of the blood-brain barrier may help in the selection of appropriate therapy. Amino acid imaging using 11C-methionine is being evaluated in patients with brain tumors and provides different information than FDG imaging.52 references.

  11. 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

  12. Home Start Evaluation Study.

    ERIC Educational Resources Information Center

    High/Scope Educational Research Foundation, Ypsilanti, MI.

    Case studies of seven Home Start programs are given as the third section of an evaluation study. Communities involved are Huntsville, Alabama; Fairbanks, Alaska; Fort Defiance, Arizona; Dardanelle, Arkansas; Wichita, Kansas; Gloucester, Massachusetts; and Reno, Nevada. Although each study varies in format, each describes in detail the degree and…

  13. 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

  14. The design of a force platform for clinical use: a feasibility study of stabilography in evaluating the effect of orthotic intervention in Duchenne muscular dystrophy.

    PubMed

    Barrett, R; Hyde, S A; Hark, W B

    1987-01-01

    A force platform was built that was shown to meet the design and operating specifications for clinical use in the application of techniques of stabilography to investigate disturbances of equilibrium in young boys with Duchenne muscular dystrophy. The force platform was tested for reliability and repeatability and results were at an acceptable level for clinical application. Further, the design of the force platform and the associated software for system operation and computation of results were usable by non-technical staff. A feasibility study reporting the effect of the application of orthoses to a group of eight boys with Duchenne muscular dystrophy, who had lost the ability to walk independently, is represented. PMID:3612741

  15. A correlative study of clinical-pathologic characteristics of human brain tumors and blood brain barrier (BBB) permeability evaluated with Ga-68 EDTA and positron emission tomography

    SciTech Connect

    Wapenski, J.A.; Hawkins, R.A.; Mazziotta, J.C.; Phelps, M.E.; Huang, S.C.

    1985-05-01

    The authors investigated the relationship between quantitative estimates of BBB permeability and the clinical and pathologic characteristics of human brain tumors. BBB permeability in 12 patients with either primary (4) or metastatic (8) brain tumors were studied with Ga-68 EDTA and PET with a two compartment model. The clinical and pathologic characteristics of the tumors were reviewed retrospectively. PET estimates of the transfer constant K/sub 1/ (ml/min/gm) paralleled the X-ray CT evidence of BBB disruption. Biopsies of four patients provided histologic support for the presumed pathophysiologic mechanism of BBB disruption, in the degree of alteration of brain vascularity and cellular architecture. For example, a patient with a hemorrhagic melanoma and a K/sub 1/ = 0.0049 ml/min/gm had gross hemorrhage, little recognizeable brain tissue and evidence of neovascularization on biopsy.

  16. A randomized controlled clinical study to evaluate the effectiveness of an active moisturizing lotion with colloidal oatmeal skin protectant versus its vehicle for the relief of xerosis.

    PubMed

    Kalaaji, Amer N; Wallo, Warren

    2014-10-01

    Xerosis is a common skin condition, occurring most often in the winter and in low relative humidity, which results in loss of moisture, cracking, and desquamation. Many emollient creams and lotions are available for use as preventive moisturizers. However, few controlled experiments have been published comparing the efficacy of active moisturizing products versus the vehicle used to deliver the products to the skin. Therefore, we conducted this randomized, double-blind, controlled clinical study to objectively compare a commercially available moisturizing product against its own vehicle. The active colloidal oatmeal moisturizer used in this study showed significant benefits versus its vehicle control in several dermatological parameters used to measure skin dryness. PMID:25607563

  17. 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. PMID:25924999

  18. Evaluation of hydroxyapatite (Periobone-G) as a bone graft material and calcium sulfate barrier (Capset) in treatment of interproximal vertical defects: A clinical and radiologic study

    PubMed Central

    Gupta, Sanjay; Vandana, K. L.

    2013-01-01

    Background: This study has been undertaken to assess treatment response of interproximal vertical defects using an alloplast (Periobone-G) and calcium sulfate (Capset) as a barrier both clinically and radiographically. Materials and Methods: Eight patients were selected with 16 sites that were divided into control and experimental sites based on split mouth study design. Plaque index, gingival index, probing depth, clinical attachment level, gingival margin position were recorded at baseline and 9 months and radiographic assessment was done at baseline and 9 months after recording clinical parameters, the sites were randomly treated either with hydroxyapatite granules Periobone-G or hydroxyapatite granules (control group) was used to fill the osseous defect and calcium sulfate (Capset) (experiment group) barrier was placed. Result: The plaque score reduction was statistically highly significant within control and experimental groups. The gingival score reduction was significant within control and experimental groups, although there were no significant difference between the 2 groups. The pocket depth reduction was significant within control and experimental group, however, the hydroxyapatite + capset group showed significant reduction as compared with hydroxyapatite alone group. The clinical attachment gain and gingival margin position was significant within control and experimental groups, although there was no significant difference between the 2 groups. The amount of defect fill was significant in both control and experimental groups but the difference between the 2 groups was not significant. The mean change in alveolar crest level between control and experimental groups was significant (P=0.02). The percentage of original defect resolved was not significant. Conclusion: The use of calcium sulfate as a barrier proved its role in the treatment of interproximal defects. The application of calcium sulfate (Capset) barrier is easy and simple. The multifaceted

  19. Evaluation of nonlinear frequency compression: Clinical outcomes

    PubMed Central

    Glista, Danielle; Scollie, Susan; Bagatto, Marlene; Seewald, Richard; Parsa, Vijay; Johnson, Andrew

    2009-01-01

    This study evaluated prototype multichannel nonlinear frequency compression (NFC) signal processing on listeners with high-frequency hearing loss. This signal processor applies NFC above a cut-off frequency. The participants were hearing-impaired adults (13) and children (11) with sloping, high-frequency hearing loss. Multiple outcome measures were repeated using a modified withdrawal design. These included speech sound detection, speech recognition, and self-reported preference measures. Group level results provide evidence of significant improvement of consonant and plural recognition when NFC was enabled. Vowel recognition did not change significantly. Analysis of individual results allowed for exploration of individual factors contributing to benefit received from NFC processing. Findings suggest that NFC processing can improve high frequency speech detection and speech recognition ability for adult and child listeners. Variability in individual outcomes related to factors such as degree and configuration of hearing loss, age of participant, and type of outcome measure. PMID:19504379

  20. Clinical and postextraction evaluation of periodontal disease indicators

    PubMed Central

    Kolte, Rajashri; Kolte, Abhay; Wattamwar, Pooja

    2016-01-01

    Background: Clinical attachment level is the most frequently used and acceptable parameter in monitoring periodontal status in diseased individual and denotes patterns of periodontal destruction. Awareness of root morphology and the condition of the periodontal tissues is essential for reliable periodontal pocket probing and for effective debridement of root surfaces. Clinically, it is challenging to observe exact nature of complex periodontal attachment loss. The aim of the present study was to evaluate patterns of periodontal destruction based on vertical and horizontal attachment loss. Materials and Methods: A total of 200 extracted teeth were obtained from chronic periodontitis patients. Prior to extraction, clinical measurements were recorded and after extraction, the teeth were stained with crystal violet. Root length, vertical and horizontal attachment loss were measured using digital caliper. Results: There was a significant difference between clinical attachment level and vertical attachment loss for both maxillary and mandibular teeth. Mean vertical attachment loss varied between 5.17 mm and 9.17 mm. Interproximal surfaces exhibited statistically significant vertical attachment loss in both maxillary and mandibular dentition. Results indicated that vertical attachment loss was more severe with teeth belonging to the anterior sextant whereas the horizontal attachment loss was more pronounced with posterior teeth. Conclusion: Both vertical and horizontal attachment loss were observed in all periodontally involved teeth. There was a difference in clinical measurements and actual periodontal status denoted by postextraction staining. These findings have an impact on determining the prognosis and appropriate treatment plan for patients. PMID:27143828

  1. [Clinical evaluation of faropenem against infections in pediatric fields].

    PubMed

    Sunakawa, K; Satoh, Y; Iwata, S; Terashima, I; Meguro, H; Kusumoto, Y; Kato, T; Akita, H; Goshima, T; Yokota, T; Toyonaga, Y; Ishihara, T; Kanemura, H; Iwai, N; Nakamura, H; Nakashima, M

    1997-09-01

    The recent increases in the prevalence of penicillin-resistant Streptococcus pneumoniae becomes a point at issue clinically. We carried out a clinical study in 40 cases in the pediatrics department, as faropenem (FRPM) was proved to have an excellent antimicrobial activity against penicillin-resistant Streptococcus pneumoniae. The study was planned to investigate in detail the movement of stools that had been a problem in a clinical development studies out before. In this study, an observation of the daily movement of stools was one of the principal evaluation items, hence the patients were divided into two groups. One group (S-group) were administered FRPM only, the other group (E-group) were administered FRPM in combination with a medicine for intestinal disorders (Enteronon-R). An observed frequencies of any loose bowel movements were 94.7% in S-group, and 63.2% in E-group, hence the study suggested that the combination drug was effective. The patients observed higher frequencies of development of the movement of stools, all of them were recovered from in the course of administration or within 4 days after administration, however whether or not being treated symptomatic therapy. Clinical efficacy rates of FRPM on mainly respiratory infections were 94.6%. In this study, 4 strains (patients) of penicillin-resistant Streptococcus pneumoniae were isolated. Against penicillin-resistant Streptococcus pneumoniae, FRPM demonstrated more potent antibacterial activity than the oral penicillins and cephems tested here except cefditoren. Clinical efficacies was deemed effective in all of the 4 cases, and bacteriologically, 3 organisms were eradicated. As for side effects including diarrhea and loose stool, no serious side effects were observed. Based on the above results, FRPM is effective against most infections in the pediatric field which Streptococcus pneumoniae are isolated at high frequencies highly, and is considered to cases in be useful an attention will have to be

  2. Evaluating suspected work-related neurologic disorders (clinical diagnosis).

    PubMed

    Lotti, Marcello; Aminoff, Michael J

    2015-01-01

    The clinical diagnosis of work-related neurologic disorders is essentially one of exclusion because symptoms and signs are often nonspecific. The clinical reasoning requires a three-step approach: (1) establish the characteristics of the presenting disease; (2) ascertain that observed clinical features are consistent with those caused by the suspected agent(s); and (3) assess occupational exposures. A detailed history is of paramount importance in evaluating patients with suspected work-related neurologic disorders as it is in other clinical contexts, especially because in some circumstances it may represent the only criterion to establish causality. Thus, besides characterization of neurologic symptoms, including their location, quality, timecourse, and possible other associated symptoms, the work environment of the patient should be understood in full detail. In this respect, when a neurotoxin is suspected, then the history collection can be guided by the knowledge of the likely syndromes it produces. Similarly, physical examination should be directed to the target of toxicity/entrapment based on information from the work history. Although specific sites and elements of the nervous system may be affected depending on the offending agent, most neurotoxic disorders are characterized by generalized rather than focal neurologic abnormalities. Laboratory toxicologic tests have limited application for the etiologic diagnosis of neurotoxic disorders, except in cases of acute poisoning and in patients exposed to neurotoxic chemicals with prolonged half-life. In most cases examination takes place after the end of exposure, when the offending chemical is no longer detectable in body fluids. Electrophysiologic studies, in particular evoked potentials, electromyography, and conduction velocities, are important to confirm the organic basis of symptoms, particularly to detect subclinical or early neurologic involvement and to reduce the number of disorders to be considered in

  3. Evaluating the Real-World Effectiveness of Cognitive-Behavior Therapy Efficacy Research on Eating Disorders: A Case Study from a Community-based Clinical Setting

    PubMed Central

    Lowe, Michael R.; Bunnell, Douglas W.; Neeren, Amy M.; Chernyak, Yelena; Greberman, Laurel

    2009-01-01

    Objective There is a growing consensus that there is a need to test the real-world effectiveness of eating disorder therapies that show promise in efficacy research. The current paper provides a narrative account of an NIMH-funded study that attempted to apply efficacy findings from CBT research to an Intensive Outpatient Program (IOP) at the largest community-based eating disorder program in the United States. Method We describe the study as originally envisioned as well as the various challenges that the researchers and the IOP staff encountered in implementing this study. Results The different training, assumptions, and “ways of knowing” of the research team and the treatment staff in regard to the nature of eating disorders and their treatment created multiple challenges for both groups during the study period. We describe valuable lessons learned about how to - and how not to -implement effectiveness designs in clinical settings that are relatively unfamiliar with empirically-based research findings. Discussion It is hoped that our experience in attempting to apply efficacy-based research findings on eating disorders treatment in a community-based clinical setting will prove helpful to other researchers and service providers engaging in such translational research. PMID:20063375

  4. A clinical study to evaluate the efficacy of Trataka Yoga Kriya and eye exercises (non-pharmocological methods) in the management of Timira (Ammetropia and Presbyopia).

    PubMed

    Gopinathan, G; Dhiman, Kartar Singh; Manjusha, R

    2012-10-01

    Timira is a disease that can be attributed to wide range of clinical conditions starting from mild blurring of vision and having potential risk of permanent vision loss. According to the involvement of Dhatus (body elements) the condition can be grouped into two stages. The initial stage or Uttana, where the involvement of Dhatus is limited to Rasa, Rakta (blood), and Mamsa Dhatu (muscle tissue). When the Doshas are localized in the first and second Patala refractive error do happen and in presbyopia more emphasis is given to Mamsa Dhatu. In this study only Uttana stage of Timira was considered. The clinical study was done on 66 patients of Timira in two groups of four sub groups each of myopia, hypermetropia, astigmatism, and presbyopia. Group A was subjected to eye exercises (Bates method) and Group B was subjected to Trataka Yoga Kriya. After the enrolment of patients for this study, signs and symptoms were assessed both subjectively and objectively before, during, and after treatment. The study indicates that subjectively there are significant results in both the groups but objectively there is not much improvement. PMID:23723673

  5. A clinical study to evaluate the efficacy of Trataka Yoga Kriya and eye exercises (non-pharmocological methods) in the management of Timira (Ammetropia and Presbyopia)

    PubMed Central

    Gopinathan, G.; Dhiman, Kartar Singh; Manjusha, R.

    2012-01-01

    Timira is a disease that can be attributed to wide range of clinical conditions starting from mild blurring of vision and having potential risk of permanent vision loss. According to the involvement of Dhatus (body elements) the condition can be grouped into two stages. The initial stage or Uttana, where the involvement of Dhatus is limited to Rasa, Rakta (blood), and Mamsa Dhatu (muscle tissue). When the Doshas are localized in the first and second Patala refractive error do happen and in presbyopia more emphasis is given to Mamsa Dhatu. In this study only Uttana stage of Timira was considered. The clinical study was done on 66 patients of Timira in two groups of four sub groups each of myopia, hypermetropia, astigmatism, and presbyopia. Group A was subjected to eye exercises (Bates method) and Group B was subjected to Trataka Yoga Kriya. After the enrolment of patients for this study, signs and symptoms were assessed both subjectively and objectively before, during, and after treatment. The study indicates that subjectively there are significant results in both the groups but objectively there is not much improvement. PMID:23723673

  6. 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

  7. 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. PMID:25954590

  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. 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. PMID:26406126

  10. 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. PMID:24259410

  11. Rationale and design of a clinical trial of a low-molecular-weight heparin in preventing clinically important venous thromboembolism in medical patients: the prospective evaluation of dalteparin efficacy for prevention of venous thromboembolism in immobilized patients trial (the PREVENT study).

    PubMed

    Vaitkus, Paul T; Leizorovicz, A; Goldhaber, S Z

    2002-01-01

    The utility of low-molecular-weight heparin (LMWH) in the prophylaxis of venous thromboembolic disease has been examined using the surrogate endpoint of venographically identified thrombi. The largest portion of these thrombi were asymptomatic calf-vein thrombi. The clinical relevance of this observation is a matter of debate. The present study is designed to evaluate the impact of an LMWH on clinically important endpoints. The current study is a randomized, prospective, double-blinded, multicenter, multinational, controlled clinical trial comparing dalteparin with placebo in moderately high-risk hospitalized medical patients. A total of 3300 patients will be randomized to receive either 5,000 IU per day of dalteparin or placebo for 14 days. Patients will undergo appropriate evaluation for any symptomatic episodes and all patients will undergo a bilateral compression ultrasound (CUS) on day 21 to search for asymptomatic proximal thrombi. The primary endpoint is the combination of objectively confirmed symptomatic deep vein thrombi (DVT), fatal or non-fatal pulmonary emboli, all proximal DVT, and sudden death. This study will be the first study to examine clinically important endpoints in evaluating the effect of a LMWH in hospitalized medical patients. This study also is the first study to use CUS rather than venography in concordance with contemporary medical practice. This trial is thus designed to address this important question in a clinically relevant manner. PMID:12710842

  12. Evaluating the Clinical Utility of the Medical Symptom Validity Test (MSVT): A Clinical Series.

    PubMed

    Suesse, Mareike; Wong, Vivien W C; Stamper, Laura L; Carpenter, Katherine N; Scott, Richard B

    2015-01-01

    Performance validity tests (PVTs) are not widely used beyond medico-legal contexts in the UK. A UK survey suggests clinicians have reservations about their accuracy in clinical settings. This study sought to explore the validity of PVTs in an acute adult neuropsychology setting and to establish a potential "false positive" (FP) base rate. Failures on the Medical Symptom Validity Test (MSVT) in a consecutive clinical series of 405 patients were evaluated systematically and allocated to groups depending on clinical context. All failures were checked against the test's "dementia profile". Of the 405 participants, 329 passed the MSVT (81.2%), while 76 participants (18.8%) failed based on standard criteria. A 5.2% rate of potentially 'unexplained' failures was found. Other reasons for failure were classified as: presumed malingered neurocognitive dysfunction (4.6%), dementia/significant cognitive impairment (3.7%), technical/visual problems (1.8%), and "unexplained failure" with contributory factors (2.4%). These results suggest test specificity between 0.95 and 0.90. Most of the clinically significantly impaired patients matched the dementia profile (86.7%). Our results support the sensitivity, but not the specificity, of the dementia profile. However, approximately 1 in 20 patients failed the MSVT despite an otherwise unremarkable neuropsychological presentation; moreover, mood and pain may affect MSVT performance. Clinical implications for interpreting test scores are discussed. PMID:25798743

  13. Clinical Use and Evaluation of Insulin Pens.

    PubMed

    Ginsberg, Barry H

    2016-01-01

    Insulin pens are more accurate and easier to teach than other methods of insulin delivery. They also do not suffer from the risk of mismatch of insulin concentration and type of insulin syringe. The ISO standard used to test insulin pens, however, needs to be updated to reflect their clinical use. PMID:26323484

  14. 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. PMID:19393523

  15. 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

  16. Systematic Review and Meta-Analysis of Studies Evaluating Diagnostic Test Accuracy: A Practical Review for Clinical Researchers-Part I. General Guidance and Tips

    PubMed Central

    Kim, Kyung Won; Lee, Juneyoung; Choi, Sang Hyun; Huh, Jimi

    2015-01-01

    In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods. PMID:26576106

  17. Systematic Review and Meta-Analysis of Studies Evaluating Diagnostic Test Accuracy: A Practical Review for Clinical Researchers-Part I. General Guidance and Tips.

    PubMed

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

    2015-01-01

    In the field of diagnostic test accuracy (DTA), the use of systematic review and meta-analyses is steadily increasing. By means of objective evaluation of all available primary studies, these two processes generate an evidence-based systematic summary regarding a specific research topic. The methodology for systematic review and meta-analysis in DTA studies differs from that in therapeutic/interventional studies, and its content is still evolving. Here we review the overall process from a practical standpoint, which may serve as a reference for those who implement these methods. PMID:26576106

  18. A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India

    PubMed Central

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    Aim A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. Objectives Primary objective: 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). Secondary objective: 1. Clinical and procedural success. Materials and methods This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. Results MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Conclusion Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. PMID:25634405

  19. 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

  20. 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. PMID:25954360

  1. Rubrics for clinical evaluation: objectifying the subjective experience.

    PubMed

    Isaacson, Julie J; Stacy, Annette S

    2009-03-01

    Rubrics have historically been used in secondary and higher education to evaluate specific assignments or tasks. There is little mention of rubrics in the nursing literature, particularly in the area of clinical evaluation. A strong case can be made for expanding the traditional use of a rubric to include its validity with clinical evaluation. Clinical evaluation remains a challenge, even for seasoned faculty. Faculty and students often interpret clinical course objectives differently. Coupled with this concern is the subjectivity of the evaluation. The use of "novice" clinical faculty, who inevitably struggle with discerning and justifying anything but stellar student performance, further compounds these issues. Rubrics also facilitate the grading experience for faculty and students. Faculty often find themselves making repetitive written comments to students. These comments can be incorporated into the rubric, thus shortening grading time while increasing the quality and quantity of instructor feedback. When clarified in a rubric, course objectives become "real". Student benefits include increased critical thinking and a more realistic approach to self-evaluation. Clinical rubrics can be developed from existing course objectives. Though perhaps tedious in initial development, both faculty and student satisfaction with the clinical evaluation process can be enhanced with the use of rubrics. PMID:19083270

  2. "A child's nightmare. Mum comes and comforts her child." Attachment evaluation as a guide in the assessment and treatment in a clinical case study.

    PubMed

    Salcuni, Silvia; Di Riso, Daniela; Lis, Adriana

    2014-01-01

    There is a gap between proposed theoretical attachment theory frameworks, measures of attachment in the assessment phase and their relationship with changes in outcome after a psychodynamic oriented psychotherapy. Based on a clinical case study of a young woman with Panic Attack Disorder, this paper examined psychotherapy outcome findings comparing initial and post-treatment assessments, according to the mental functioning in S and M-axis of the psychodynamic diagnostic manual. Treatment planning and post-treatment changes were described with the main aim to illustrate from a clinical point of view why a psycho-dynamic approach, with specific attention to an "attachment theory stance," was considered the treatment of choice for this patient. The Symptom Check List 90 Revised (SCL-90-R) and the Shedler-Westen Assessment Procedure (SWAP-200) were administered to detect patient's symptomatic perception and clinician's diagnostic points of view, respectively; the Adult Attachment Interview and the Adult Attachment Projective Picture System (AAP) were also administered as to pay attention to patient's unconscious internal organization and changes in defense processes. A qualitative description of how the treatment unfolded was included. Findings highlight the important contribution of attachment theory in a 22-month psychodynamic psychotherapy framework, promoting resolution of patient's symptoms and adjustment. PMID:25191293

  3. Clinical Evaluation of Effects of Chronic Resveratrol Supplementation on Cerebrovascular Function, Cognition, Mood, Physical Function and General Well-Being in Postmenopausal Women—Rationale and Study Design

    PubMed Central

    Evans, Hamish Michael; Howe, Peter Ranald Charles; Wong, Rachel Heloise Xiwen

    2016-01-01

    Background: This methodological paper presents both a scientific rationale and a methodological approach for investigating the effects of resveratrol supplementation on mood and cognitive performance in postmenopausal women. Postmenopausal women have an increased risk of cognitive decline and dementia, which may be at least partly due to loss of beneficial effects of estrogen on the cerebrovasculature. We hypothesise that resveratrol, a phytoestrogen, may counteract this risk by enhancing cerebrovascular function and improving regional blood flow in response to cognitive demands. A clinical trial was designed to test this hypothesis. Method: Healthy postmenopausal women were recruited to participate in a randomised, double-blind, placebo-controlled (parallel comparison) dietary intervention trial to evaluate the effects of resveratrol supplementation (75 mg twice daily) on cognition, cerebrovascular responsiveness to cognitive tasks and overall well-being. They performed the following tests at baseline and after 14 weeks of supplementation: Rey Auditory Verbal Learning Test, Cambridge Semantic Memory Battery, the Double Span and the Trail Making Task. Cerebrovascular function was assessed simultaneously by monitoring blood flow velocity in the middle cerebral arteries using transcranial Doppler ultrasound. Conclusion: This trial provides a model approach to demonstrate that, by optimising circulatory function in the brain, resveratrol and other vasoactive nutrients may enhance mood and cognition and ameliorate the risk of developing dementia in postmenopausal women and other at-risk populations. PMID:27005658

  4. 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.

  5. 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…

  6. A clinical and radiological evaluation of the relative efficacy of demineralized freeze-dried bone allograft versus anorganic bovine bone xenograft in the treatment of human infrabony periodontal defects: A 6 months follow-up study

    PubMed Central

    Blaggana, Vikram; Gill, Amarjit Singh; Blaggana, Anshu

    2014-01-01

    Background: The ultimate goal of periodontal therapy entails regeneration of the periodontal tissues lost as a consequence of periodontitis. Predictable correction of vertical osseous defects has however posed as a constant therapeutic challenge. The aim of our present study is to evaluate the relative efficacy of demineralized freeze-dried bone allograft (DFDBA) vs anorganic bovine bone xenograft (ABBX) in the treatment of human infrabony periodontal defects. Materials and Methods: 15 patients with 30 bilaterally symmetrical defect sites in either of the arches, in the age group of 25-50 years were selected as part of split-mouth study design. Defect-A (right side) was grafted with DFDBA while Defect-B (left side) was grafted with ABBX. Various clinical and radiographic parameters viz. probing depth(PD), clinical attachment level(CAL) and linear bone fill were recorded preoperatively, 12- & 24-weeks postoperatively. Results: Both defect-A & defect-B sites exhibited a highly significant reduction in probing depth, and gain in clinical attachment level and linear bone fill at 12-weeks & at the end of 24-weeks. Comparative evaluation between the study groups revealed a statistically non-significant reduction in probing depth (P<0.1) and mean gain in linear bone fill (P<0.1). However, there was a statistically significant gain in clinical attachment level (P<0.05) in Defect-A (CD=0.356) as compared to Defect-B (CD=0.346). Conclusions: Within the limits of this study, both the materials viz. ABBX and DFDBA are beneficial for the treatment of periodontal infrabony defects. Both the materials were found to be equally effective in all respects except the gain in attachment level, which was found to be more with DFDBA. Long-term studies are suggested to evaluate further the relative efficacy of the two grafts. PMID:25425822

  7. Neurobiology of early life stress: clinical studies.

    PubMed

    Heim, Christine; Nemeroff, Charles B

    2002-04-01

    A burgeoning number of clinical studies have evaluated the immediate and long-term neurobiological effects of early developmental stress, eg, child abuse and neglect or parental loss, in the past years. This review summarizes and discusses the available findings from neuroendocrine (hypothalamic-pituitary-adrenal axis, other neuroendocrine axes), neurochemical (catecholamines, serotonin, other neurotransmitters), psychophysiological (autonomic function, startle reactivity, brain electrical activity) and neuroimaging studies (brain structure, function) conducted in children or adults with a history of early life stress, with or without psychiatric disorders. Early developmental stress in humans appears to be associated with neurobiological alterations that are similar to many findings in animal models of early life stress, and likely represent the biological basis of an enhanced risk for psychopathology. Clinical studies are now beginning to explore potentially differential neurobiological effects of different types of early life stress and the existence of critical developmental periods, which may be sensitive to the neurobiological effects of specific stressors. In addition, the role of a multitude of moderating and mediating factors in the determination of individual vulnerability or resilience to the neurobiological effects of early life stress should be addressed. Findings from such studies may ultimately help to prevent the deleterious neurobiological and psychopathological consequences in the unacceptably high number of children exposed to early life stress in modern society. PMID:11953939

  8. Clinical Mental Health Counselor Handbook & Study Guide.

    ERIC Educational Resources Information Center

    Bullard, Bonnie; Lawless, Linda; Williams, Midge; Bergstrom, Deborah

    This handbook and study guide were developed as a textbook to be used as a review course for preparation for the clinical licensing examination. It presents a summary of a graduate level academic program in clinical mental health counseling. It contains 17 chapters on clinical information; 4 chapters on test taking; 2 types of sample tests; and 3…

  9. CONTROLLED CLINICAL EVALUATIONS OF CHLORINE DIOXIDE, CHLORITE AND CHLORATE IN MAN

    EPA Science Inventory

    To assess the relative safety of chronically administered chlorine water disinfectants in man, a controlled study was undertaken. The clinical evaluation was conducted in the three phases common to investigational drug studies. Phase I, a rising does tolerance investigation, exam...

  10. A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice.

    PubMed

    Barni, S; Lorusso, V; Giordano, M; Sogno, G; Gamucci, T; Santoro, A; Passalacqua, R; Iaffaioli, V; Zilembo, N; Mencoboni, M; Roselli, M; Pappagallo, G; Pronzato, P

    2014-01-01

    Febrile neutropenia (FN) is a severe dose-limiting side effect of myelosuppressive chemotherapy in patients with solid tumors. Clinical practice guidelines recommend primary prophylaxis with G-CSF in patients with an overall ≥ 20 % risk of FN. AIOM Italian guidelines recommend starting G-CSF within 24-72 h after chemotherapy; for daily G-CSF, administration should continue until the absolute neutrophil count (ANC) is 1 × 10(9)/L post-nadir and should not be terminated after ANC increase in the early days of administration. The aim of this study was to assess guideline adherence in oncology practice in Italy. In this multicenter, prospective, observational study, patients were enrolled at the first G-CSF use in any cycle and were followed for two subsequent cycles (or until the end of chemotherapy if less than two additional cycles). Primary objective was to explore G-CSF use in Italian clinical practice; therefore, data were collected on the G-CSF type, timing of administration, and number of doses. 512 eligible patients were enrolled (median age, 62). The most common tumor types were breast (36 %), lung (18 %), and colorectal (13 %). A total of 1,164 G-CSF cycles (daily G-CSF, 718; pegfilgrastim, 446) were observed. Daily G-CSF was administered later than 72 h after chemotherapy in 42 % of cycles, and the median [range] number of doses was four [1, 10]. Pegfilgrastim was administered later than 72 h in 8 % of cycles. G-CSF prophylaxis in Italy is frequently administered in a manner which is not supported by evidence-based guidelines. As this practice may lead to poor outcomes, educational initiatives are recommended. PMID:24307348

  11. Validation, clinical trial, and evaluation of a radiology expert system.

    PubMed

    Kahn, C E

    1991-10-01

    The PHOENIX Radiology Consultant is a rule-based expert system which assists physicians in planning radiological work-up strategies. This article describes the methods used to create and validate the system's knowledge base. The feasibility and acceptability of PHOENIX were tested for two years in a clinical trial. During this period, the system was used 1,421 times, an average of 13.7 times per week, primarily by medical students and nonradiologist physicians. Much of the system's use occurred at night and on weekends, when the radiology department was not fully staffed. Several physicians were enlisted to further evaluate the utility of the system. The results of their evaluation indicate that an expert system that helps physicians select diagnostic-imaging studies can serve as a useful and informative component of a radiology information system, and is particularly useful for medical students and physicians in training. PMID:1762580

  12. 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. PMID:23805547

  13. Clinical Evaluation of Heart Failure: Agreement among Tests

    PubMed Central

    Pandey, Amit K.; Penny, William F.; Bhargava, Valmik; Lai, N. Chin; Xu, Ronghui; Hammond, H. Kirk

    2016-01-01

    Methods commonly used clinically to assess cardiac function in patients with heart failure include ejection fraction (EF), exercise treadmill testing (ETT), and symptom evaluation. Although these approaches are useful in evaluating patients with heart failure, there are at times substantial mismatches between individual assessments. For example, ETT results are often discordant with EF, and patients with minimal symptoms sometimes have surprisingly low EFs. To better define the relationship of these methods of assessment, we studied 56 patients with heart failure with reduced EF (HFrEF) who underwent measurement of ETT duration, EF by echocardiography, quantitative symptom evaluation, and LV peak dP/dt (rate of left ventricular pressure development and decline, measured invasively). Correlations were determined among these four tests in order to assess the relationship of EF, ETT, and symptoms against LV peak dP/dt. In addition, we sought to determine whether EF, ETT, and symptoms correlated with each other. Overall, correlations were poor. Only 15 of 63 total correlations (24%) were significant (p < 0.05). EF correlated most closely with LV peak -dP/dt. Linear regression analysis indicated that EF, ETT, and symptoms taken together predicted LV peak dP/dt better than any one measure alone. We conclude that clinical tests used to assess LV function in patients with HFrEF may not be as accurate or correlate as well as expected. All three clinical measures considered together may be the best representation of cardiac function in HFrEF patients currently available. PMID:27537778

  14. Clinical Evaluation of Heart Failure: Agreement among Tests.

    PubMed

    Pandey, Amit K; Penny, William F; Bhargava, Valmik; Lai, N Chin; Xu, Ronghui; Hammond, H Kirk

    2016-01-01

    Methods commonly used clinically to assess cardiac function in patients with heart failure include ejection fraction (EF), exercise treadmill testing (ETT), and symptom evaluation. Although these approaches are useful in evaluating patients with heart failure, there are at times substantial mismatches between individual assessments. For example, ETT results are often discordant with EF, and patients with minimal symptoms sometimes have surprisingly low EFs. To better define the relationship of these methods of assessment, we studied 56 patients with heart failure with reduced EF (HFrEF) who underwent measurement of ETT duration, EF by echocardiography, quantitative symptom evaluation, and LV peak dP/dt (rate of left ventricular pressure development and decline, measured invasively). Correlations were determined among these four tests in order to assess the relationship of EF, ETT, and symptoms against LV peak dP/dt. In addition, we sought to determine whether EF, ETT, and symptoms correlated with each other. Overall, correlations were poor. Only 15 of 63 total correlations (24%) were significant (p < 0.05). EF correlated most closely with LV peak -dP/dt. Linear regression analysis indicated that EF, ETT, and symptoms taken together predicted LV peak dP/dt better than any one measure alone. We conclude that clinical tests used to assess LV function in patients with HFrEF may not be as accurate or correlate as well as expected. All three clinical measures considered together may be the best representation of cardiac function in HFrEF patients currently available. PMID:27537778

  15. Plantago ovata: Clinical study of overuse.

    PubMed

    Agha, Rukh-e-Nasreen; Saeed, Aftab; Nazar, Halima

    2016-03-01

    The objective of the study was to undertake evidence-base study to evaluate clinical manifestation of the over-estimated use of herbal drug Plantago ovata and to compare it with placebo for the efficacy and adverse effects. The patients of both genders were included. Blood urea, creatinine, ALT, Serum B12, CP, ESR and liver function tests were performed. The data was statistically analyzed in both groups for differential symptomatology. In anorexia test verses control results showed that Plantago ovata husk and placebo showed the affected ratio as 81 percent and 50 percent, correspondingly. Whereas in clinical performance of heart burning, pain in epigastrium, low libido, body pain, dyspepsia, fever, burning sensation in palm and sole in test drug showed affected response as adverse effect 90%, 88% and as control drug, 36%, 29%, 22%, 25%, 38%, 30%, 33%, 57%, respectively. The results were highly marked in test drug i.e. in comparison with placebo. This is clearly evident from data analysis that effect observed in test arm is far more superior hence null hypothesis was rejected clearly. Similarly serological and biochemical reports study i.e. (ALT, Vit. B1 and Vit A) revealed that there is no hepatotoxic and neurotoxic effect found in both the drugs. PMID:27087080

  16. Clinical Variability in Arch Wires: A Preliminary Study Evaluating Mechanical and Surface Characteristics of Two Different Sized Rectangular Stainless Steel Wires

    PubMed Central

    Vena, Alessandro; Carey, Jason; Badawi, Hisham

    2007-01-01

    Experimental characterization of arch wires has been performed in many previous studies; however with the advent of new arch wire materials being introduced, some new experimental methods and characterization are required. Since literature is available for comparison, this paper examines mechanical and physical characteristics of steel arch wires to quantify their variability in engineering terms. Furthermore, the effect of wire size on properties was evaluated using two of the most common wire sizes. Finally, manufacturing consistency was verified by testing samples from different lots. PMID:19662123

  17. Comparative clinical evaluation of laterally positioned pedicle graft and subepithelial connective tissue graft in the treatment of Miller's Class I and II gingival recession: A 6 months study

    PubMed Central

    Dulani, Kirti Satish; Bhavsar, Neeta Vijay; Trivedi, Sakshee Rahul; Trivedi, Rahul Anil

    2015-01-01

    Aim: The purpose of the study was to compare clinical outcomes of laterally positioned pedicle graft (LPPG) and subepithelial connective tissue graft (SCTG) for treatment of Miller's Class I and II gingival recession defects, at the end of 6 months. Materials and Methods: Sixty Miller's Class I or II gingival recession defects (≥3 mm) (n = 30 each) on the labial aspect of anterior teeth were treated by either of the above techniques. Clinical parameters including recession depth (RD), width of keratinized gingiva (WKG), percentage of root coverage (%RC), and complete RC were recorded at baseline and 6 months postoperatively. Data were recorded and statistical analysis was done for both intergroup and intragroup. Statistical Analysis Used: Paired t-test intragroup and Student's t-test intergroup. Results: In LPPG, RD decreased from 4.9 ± 0.99 mm to 1.1 ± 0.3 mm and WKG increased from 0.7 ± 0.87 to 4.5 ± 0.86 mm at 6 months, while in SCTG, RD decreased from 4.67 ± 1.12 mm to 0.46 ± 0.68 mm and WKG increased from 1.1 ± 0.99 to 5.33 ± 0.72 mm at 6 months postoperatively. The values of the soft tissue coverage remained stable for 6 months. Conclusions: Highly significant and effective soft tissue coverage was obtained by both techniques. LPPG resulted in effective soft tissue coverage for isolated deep narrow defects while SCTG in isolated and multiple, deep narrow and wide defects. PMID:26941517

  18. A comparative evaluation of freeze dried bone allograft and decalcified freeze dried bone allograft in the treatment of intrabony defects: A clinical and radiographic study

    PubMed Central

    Gothi, Rajat; Bansal, Mansi; Kaushik, Mayur; Khattak, Braham Prakash; Sood, Nikhil; Taneja, Vishal

    2015-01-01

    Background: Ideal graft material for regenerative procedures is autogenous bone graft but the major disadvantage with this graft is the need for a secondary surgical site to procure donor material and the frequent lack of intraoral donor site to obtain sufficient quantities of autogenous bone for multiple or deep osseous defects. Hence, to overcome these disadvantages, bone allografts were developed as an alternative source of graft material. Materials and Methods: In 10 patients with chronic periodontitis, 20 bilateral infrabony defects were treated with freeze dried bone allograft (FDBA-Group A) and decalcified freeze dried bone allograft (DFDBA-Group B). Clinical and radiographic parameters were assessed preoperatively and at 3 months and 6 months postoperatively. Data thus obtained was subjected to statistical analysis. Results: Significant improvement in the reduction in probing depth and relative attachment level (RAL) from the baseline to 3 months to baseline to 6 months in group A and group B, which was statistically significant but no statistically significant reduction was seen between 3 months and 6 months. On inter-group comparison, no significant differences were observed at all-time points. In adjunct to the probing depth and RAL, the radiographic area of the defect showed a similar trend in intra-group comparison and no significant difference was seen on inter-group comparison at all-time points. Conclusions: Within the limitations of the current study, it can be concluded that DFDBA did not show any improvement in the clinical and radiographic parameters in the treatment of the intrabony defects as compared to FDBA. PMID:26392690

  19. Evaluating Multimedia Interventions in Community-Based Clinics

    PubMed Central

    Sweeney, Mary Anne; Skiba, Diane; Lester, Jerry

    1993-01-01

    The Healthy Touch™ Series of multimedia programs has been developed, implemented, and evaluated in selected community clinics over the past year. A high-tech effort in carrying out the design and evaluation of the programs has resulted in a new intervention in clinical care with positive outcomes for both patients and staff. Utilization of the technology has opened up the opportunity to provide consistent, individualized, and enjoyable programs that invite easy patient participation.

  20. Evaluation of electronic biopsy for clinical diagnosis in virtual colonoscopy

    NASA Astrophysics Data System (ADS)

    Marino, Joseph; Du, Wei; Barish, Matthew; Li, Ellen; Zhu, Wei; Kaufman, Arie

    2011-03-01

    Virtual colonoscopy provides techniques not available in optical colonoscopy, an exciting one being the ability to perform an electronic biopsy. An electronic biopsy image is created using ray-casting volume rendering of the CT data with a translucent transfer function mapping higher densities to red and lower densities to blue. The resulting image allows the physician to gain insight into the internal structure of polyps. Benign tissue and adenomas can be differentiated; the former will appear as homogeneously blue and the latter as irregular red structures. Although this technique is now common, is included with clinical systems, and has been used successfully for computer aided detection, there has so far been no study to evaluate the effectiveness of a physician using electronic biopsy in determining the pathological state of a polyp. We present here such a study, wherein an experienced radiologist ranked polyps based on electronic biopsy alone per scan (supine and prone), as well as both combined. Our results show a correct identification 77% of the time using prone or supine images alone, and 80% accuracy using both. Using ROC analysis based on this study with one reader and a modest sample size, the combined score is not significantly higher than using a single electronic biopsy image alone. However, our analysis indicates a trend of superiority for the combined ranking that deserves a follow-up confirmatory study with a larger sample and more readers. This study yields hope that an improved electronic biopsy technique could become a primary clinical diagnosis method.

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

    PubMed

    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

  2. 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

  3. 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

  4. 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. PMID:26369943

  5. Long-term clinical evaluation of endodontically treated teeth by 15 F CO2 laser microprobe: three years clinical follow-up of 1512 root canals--in-vivo study

    NASA Astrophysics Data System (ADS)

    Kesler, Gavriel; Koren, Rumelia; Kesler, Anat; Hay, Nissim; Gal, Rivka

    1999-05-01

    The purpose of this study was to determine the efficiency of 15 F CO2 laser microprobe, in cases of periapical lesions, by eliminating the pathological reaction caused by certain species of bacteria, reduction of reinfection and stimulation of osteogenesis in the periapical region. Until now, no suitable delivery fiber existed for CO2 laser endodontic radiation in the apical region where it is most difficult to eliminate the pulp tissue using conventional methods. To overcome this problem, Sharplan laser designed a microprobe that reaches closer to the apex, distributing the energy density to a smaller area of the root canal, thus favorably increasing the thermal effects. The study was conducted on 900 teeth, divided in two groups. 468 were new case, carefully selected according to strict parameters such as: wide periapical translucency over 1mm, supported by digital x-ray, with a lesion of 3mm and more. All root canals were mechanically prepared in the conventional method up to size 35, Physiological saline solution served as finding solution and were treated by 15 F CO2 laser microprobe for 60 pulses repeatedly. The temperature at the surrounding tissue of the root did not exceed 38 degrees C filling of the canal was possible at the same appointment, without antibiotical treatment. 432 of the cases, which were referred to us by other dentists, after an unsuccessful treatment according to the classical therapy, were treated by the same laser therapy. Follow up was performed by clinical examination, and digital x-ray taken, during and after treatment as well as after 3, 6, 9, 12 month. The result demonstrate 98% success rate in both study groups, according to objective criteria for a successful treatment such as: reduction of apical translucency after 2- 6 months, freedom form clinical complains, and no need for periapical surgery.

  6. Clinical and stereologic evaluation of osteochondroma.

    PubMed

    Karacayli, Umit; Gocmen-Mas, Nuket; Kaya, Ayper; Koymen, Ramazan

    2009-10-01

    Osteochondroma is a benign tumor that is unusual in the maxillofacial region. Anatomy of the region, especially the mandible, is important for surgical intervention for the condylar osteochondroma. The present case report describes evaluation of condylar hyperplasia with emphasis on the advantages and disadvantages of sterolithographic solid model and stereologic techniques for preoperative surgical planning, operation time, and prognosis. Condylar osteochondoma was diagnosed by panoramic radiograph and 3-dimensional computerized tomography (3DCT) as well as histopathologic analysis in a male patient. Before surgery, a stereolithographic model was created and stereologic method was used based upon 3DCT. PMID:19778735

  7. Clinical Evaluation of MP4CO: A Phase 1b Escalating-Dose, Safety and Tolerability Study in Stable Adult Patients with Sickle Cell Disease.

    PubMed

    Keipert, Peter E

    2016-01-01

    MP4CO, developed by Sangart Inc. (San Diego, CA), is a pegylated human hemoglobin-based carbon monoxide (CO) delivery agent and oxygen therapeutic that has shown potential to prevent and reverse red cell sickling. A double blind, comparator controlled, dose-escalation, Phase 1b study was conducted to assess the safety of MP4CO. Adult sickle cell patients with HbSS or S/β(0) Thal genotype who were not experiencing a painful crisis were randomized to receive either MP4CO or normal saline (NS) in a sequential series of six escalating dose cohorts (A-F). In each cohort, three patients received MP4CO (Treatment group) and one patient received NS (Controls). Single IV doses ranged from 15 mg/kg/dose (0.35 mL/kg infusion) to 172 mg/kg/dose (4 mL/kg infusion). Two cohorts received fractionated doses of 172 or 344 mg/kg (4-8 mL/kg, given as two IV infusions, 24 h apart). Overall, 16/24 patients (66.7 %) reported mild to moderate adverse events (AEs); with 13/18 (72 %) in MP4CO group vs. 3/6 (50 %) in NS Controls. No serious adverse events (SAEs) were experienced and no deaths occurred. Most common AEs (reported by >2 patients) included headaches (mild and transient), fatigue and rash at the application site of the Holter electrodes. No treatment-emergent abnormalities in clinical lab values were noted. Vital signs, ECG readings, and pulmonary pressures remained within normal limits. The maximum increase in blood CO-Hb level was ~2 %, which returned to pre-dosing levels within 8 h after dosing. The mean increase in free plasma Hb (an index of MP4CO dose) ranged from 0.20 to 0.35 g/dL in the two highest dose cohorts, with no significant change in total whole blood hemoglobin level. There was no symptomatic or clinical evidence of renal dysfunction in either group based on serum creatinine and urinary albumin results. Two patients had elevated renal biomarkers (β2M and NAG) at Hour 72, which normalized at follow-up visits. Both patients had documented intercurrent

  8. IT-benchmarking of clinical workflows: concept, implementation, and evaluation.

    PubMed

    Thye, Johannes; Straede, Matthias-Christopher; Liebe, Jan-David; Hübner, Ursula

    2014-01-01

    Due to the emerging evidence of health IT as opportunity and risk for clinical workflows, health IT must undergo a continuous measurement of its efficacy and efficiency. IT-benchmarks are a proven means for providing this information. The aim of this study was to enhance the methodology of an existing benchmarking procedure by including, in particular, new indicators of clinical workflows and by proposing new types of visualisation. Drawing on the concept of information logistics, we propose four workflow descriptors that were applied to four clinical processes. General and specific indicators were derived from these descriptors and processes. 199 chief information officers (CIOs) took part in the benchmarking. These hospitals were assigned to reference groups of a similar size and ownership from a total of 259 hospitals. Stepwise and comprehensive feedback was given to the CIOs. Most participants who evaluated the benchmark rated the procedure as very good, good, or rather good (98.4%). Benchmark information was used by CIOs for getting a general overview, advancing IT, preparing negotiations with board members, and arguing for a new IT project. PMID:24825693

  9. 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

  10. 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.

  11. Universal protocol for alopecia areata clinical studies.

    PubMed

    Mesinkovska, Natasha A; Bergfeld, Wilma F

    2013-12-01

    Within the area of alopecia areata research, there is an obvious need for well-designed clinical trials of therapeutic agents. The National Alopecia Areata Foundation (NAAF) has created an initiative for the development of a unified protocol with guidelines for clinical studies. The NAAF universal protocol represents a joint effort of clinicians and investigators with experience in treating alopecia areata. This protocol will serve as a tremendous resource to facilitate future clinical studies. PMID:24326554

  12. Steroid Dermatitis Resembling Rosacea: A Clinical Evaluation of 75 Patients

    PubMed Central

    Hameed, Ammar F.

    2013-01-01

    Background. The use of topical steroids on the skin of the face should be carefully evaluated by the dermatologist; however, its misuse still occurs producing dermatological problem resembling rosacea. Objectives. To report the different clinical manifestations of steroid dermatitis resembling rosacea and to discover causes behind abusing topical steroids on the face. Methods. In this prospective observational study, 75 patients with steroid dermatitis resembling rosacea who had history of topical steroid use on their faces for at least 1–3 months were evaluated at the Department of Dermatology, Baghdad Teaching Hospital, between August 2010 and December 2012. Results. The majority of patients were young women who used a combinations of potent and very potent topical steroid for average period of 0.25–10 years. Facial redness and hotness, telangiectasia, and rebound phenomenon with papulopustular eruption were the main clinical presentations. The most common causes of using topical steroid on the face were pigmentary problems and acne through recommendations from nonmedical personnel. Conclusion. Topical steroid should not be used on the face unless it is under strict dermatological supervision. PMID:23691345

  13. 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

  14. 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. PMID:25570649

  15. 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

  16. Clinical evaluation of pivmecillinam in intractable urinary-tract infections with complications. A comparative study with amoxicillin by a randomized double-blind technique.

    PubMed

    Ishigami, J; Tanikaze, S; Miyazaki, S; Ono, S; Kuroda, M; Hirooka, K; Mita, T; Sugimoto, M; Kuroda, K; Nakatsuka, E; Suemitsu, H; Tomioka, S; Takahashi, Y; Hara, S; Terasoma, K; Tanaka, K; Ueharaguchi, H; Hikosaka, K; Yasumuro, T; Kaneda, K; Akita, Y; Okano, H; Kobayashi, M; Kataoka, N

    1977-11-01

    A comparative study was made by the double-blind technique in order to make clear the usefulness of pivmecillinam in the treatment of intractable complicated urinary-tract infections using amoxicillin as a reference drug. Pivmecillinam was given in dosage of 400 mg (potency) per day which was one-fifth the dose of amoxicillin 2,000 mg (potency) per day. In global judgement, pivmecillinam was found superior to amoxicillin. It showed a "significant" superiority over amoxicillin for the treatment of, among others, the urinary-tract infections after prostatectomy, which are intractable diseases. When evaluated by symptoms, pivmecillinam improved bacteriuria "significantly" better than amoxicillin. When seen by causative organisms, the pivmecillinam treatment was "significantly" superior to the amoxicillin treatment against E. coli infections. Pivmecillinam was active against amoxicillin-resistant E. coli. Incidence of adverse reactions was less frequent with pivmecillinam than with amoxicillin. These results indicate that pivmecillinam is a drug of high usefulness for the treatment of intractable complicated urinary-tract infections when evaluated using amoxicillin as a reference drug. PMID:201786

  17. Transient ischaemic attack clinic: an evaluation of diagnoses and clinical decision making.

    PubMed

    Lee, Will; Frayne, Judith

    2015-04-01

    The diagnosis of transient ischaemic attack (TIA) is based largely on the patient's symptom recall and clinical judgement. This decision-making process is highly subjective and the inter-observer reliability of TIA diagnosis is at best moderate, even among neurologists. The aim of this study is to examine the presenting features and final diagnoses of referrals to a TIA clinic and to evaluate characteristics that favoured the diagnosis of TIA over other TIA "mimics". Consecutive new referrals to a tertiary metropolitan hospital TIA clinic over a 9month period were examined. Characteristics between TIA and non-TIA diagnoses were compared and analysed. Eighty-two patients were recruited. Eighteen (22%) were given a final diagnosis of TIA or stroke. Major alternative diagnoses included migraine (n=17, 21%), presyncope/syncope (n=13, 16%) and anxiety (n=7, 9%). Four (5%) patients had unclassifiable symptoms with no clear final diagnosis. Mean age was 67±a standard deviation of 17years and patients diagnosed with TIA/stroke were on average older than those with non-TIA diagnoses (77±10 versus 64±17years, p=0.003). A diagnosis of TIA/stroke was favoured in the presence of moderate to severe weakness (p=0.032), dysphasia (p=0.037) or dysarthria (p=0.005). Unclassifiable symptoms (for example, palpitations, confusion, headache) were reported in 27 patients (33%) and their presence favoured non-TIA diagnoses (p=0.0003). TIA constituted a minority of the referrals to our clinic. Accurate clinical diagnosis of TIA facilitates early stroke prevention and avoids unnecessary investigations and prescriptions. Attempts to improve diagnostic accuracy of TIA should target improving the education and awareness of frontline medical practitioners. PMID:25669115

  18. 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.

  19. Clinical safety evaluation of a novel barrier protection cream.

    PubMed

    Slade, Herbert B; Fowler, Joseph; Reece, Barry T; Cargill, D Innes

    2008-10-01

    Patients with contact dermatitis require both preventive and therapeutic interventions to minimize their burden of disease. The ideal product would support resolution of inflamed skin without the use of glucocorticoids while protecting undamaged skin against further contact with irritants and antigens. COR806.805 (Tetrix Cream) is a novel barrier cream formulated for use on both lesional and nonlesional skin. Three clinical trials were conducted to evaluate the safety of this new product by studying sensitization, cumulative irritation, and effect on healing; a combined total of 265 participants completed the studies (210, 45, and 10, respectively), with no serious adverse events considered to be related to the product. Six mild adverse events were considered related or potentially related. As tested, COR806.805 is neither sensitizing nor irritating when applied to intact or lesional skin. Testing indicates that COR806.805 does not inhibit healing of allergic contact dermatitis lesions. PMID:19202672

  20. Clinical evaluation of therapeutic cancer vaccines

    PubMed Central

    Ogi, Chizuru; Aruga, Atsushi

    2013-01-01

    Therapeutic cancer vaccines are an immunotherapy that targets tumor antigens to induce an active immune response. To date, Provenge® is the only therapeutic cancer vaccine approved by the United States Food and Drug Administration. Although therapeutic cancer vaccines have not been approved by the European Medicines Agency (EMA), they have been approved in several countries other than the United States (US) and the European Union (EU). Provenge® is the only approved cancer vaccine that showed significant primary endpoint efficacy in a phase III study at the time of approval. Retrospective analysis of 23 completed or terminated phase III studies showed that 74% (17/23) failed to demonstrate significant efficacy in the primary endpoint. The reasons for failure were surveyed in 13 of the 17 studies. Despite efforts to minimize tumor burden, including surgery and induction chemotherapy before therapeutic cancer vaccine therapy, 69% (9/13) of the phase III studies failed. These findings indicate that tumor burden may not be the only prognostic factor. Immunological response has often been used as a predictive factor, and a small number of sub-group analyses have succeeded in showing that immunological response is associated with the efficacy of therapeutic cancer vaccines. Being a prognostic factor, inclusion of immunological response in addition to tumor stage in the eligibility criteria or sub-group analysis may minimize study population heterogeneity, a key factor in the success of phase III studies. PMID:23454867

  1. Legal Issues in Faculty Evaluation of Student Clinical Performance.

    ERIC Educational Resources Information Center

    Kapp, Marshall B.

    1981-01-01

    Many faculty members are reluctant to evaluate the clinical performance of medical students because of fear of legal liability and lawsuits. Current methods and uses of evaluation and legal issues are discussed. The Supreme Court's decision in Board of Curators of the University of Missouri v. Horowitz is discussed. (Author/MLW)

  2. [A Critical Condition of Clinical Studies in Japan -- A Battle of Clinical Study Groups].

    PubMed

    Furukawa, Hiroshi

    2016-04-01

    The post-marketing clinical study groups have been losing their activity due to stop of financial support. As the result, clinical study groups cannot achieve any EBM for treatment guidelines. Financial supports should be restarted immediately not to extinguish the post-marketing clinical studies and study groups. PMID:27220798

  3. Development and evaluation of a clinical note section header terminology.

    PubMed

    Denny, Joshua C; Miller, Randolph A; Johnson, Kevin B; Spickard, Anderson

    2008-01-01

    Clinical documentation is often expressed in natural language text, yet providers often use common organizations that segment these notes in sections, such as history of present illness or physical examination. We developed a hierarchical section header terminology, supporting mappings to LOINC and other vocabularies; it contained 1109 concepts and 4332 synonyms. Physicians evaluated it compared to LOINC and the Evaluation and Management billing schema using a randomly selected corpus of history and physical notes. Evaluated documents contained a median of 54 sections and 27 major sections. There were 16,196 total sections in the evaluation note corpus. The terminology contained 99.9% of the clinical sections; LOINC matched 77% of section header concepts and 20% of section header strings in those documents. The section terminology may enable better clinical note understanding and interoperability. Future development and integration into natural language processing systems is needed. PMID:18999303

  4. Safety and efficacy evaluation of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) in dyslipidemia patients: A pilot prospective cohort clinical study

    PubMed Central

    Kumar, Gajendra; Srivastava, Amita; Sharma, Surinder Kumar; Gupta, Yogendra Kumar

    2012-01-01

    Cardiovascular disease has multifaceted in which dyslipidemia, inflammation, and immunity play an important role. Arjuna powder and Arogyavardhini Vati used for centuries has potential for combating these factors. Therefore, the objective of this study was to evaluate the safety and efficacy of Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) for dyslipidemia patients. Total of 108 patients were screened at CGHS Ayurvedic Hospital, New Delhi. Ninety-six patients satisfied inclusion criteria, and signed informed consent and detailed medical history was recorded. Arjuna powder (5 g, BD) for 3 weeks and then Arogyavardhini Vati (500 mg, BD) for 4 weeks were prescribed to the patients. The primary efficacy endpoint was reduction in serum total cholesterol, LDL, triglycerides, and increased HDL levels. Secondary endpoints included reduction in serum C-Reactive Protein (CRP) and blood glucose levels. Safety assessments included hepatic function (aminotransferase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), bilirubin, and β2 microglobulin), renal function (urea and creatinine and NGAL) tests, and urine mercury level. The study was completed by 87 patients. The male and female patients were 65.5% (57/87) and 34.5% (30/87), respectively. There was a significant reduction in total cholesterol, LDL, triglycerides, CRP, and blood glucose. However, raised HDL level was also observed. Safety assessment results showed no significant change in serum ALT, AST, ALP and bilirubin, urea, creatinine β2 microglobulin, and NGAL levels at the end of study as compared to the baseline levels. In conclusion, the results of the present prospective cohort study showed that Ayurvedic treatment (Arjuna powder and Arogyavardhini Vati) is safe and effective for dyslipidemia. PMID:23559790

  5. Evaluation of metformin hydrochloride in Wistar rats by FTIR-ATR spectroscopy: A convenient tool in the clinical study of diabetes

    PubMed Central

    Ramalingam, P.; Reddy, Y. Padmanabha; Kumar, K. Vinod; Chandu, Babu Rao; Rajendran, K.

    2014-01-01

    Introduction: The IR absorption patterns (in cm−1) provide the basis to distinguish among the constituents and to separately quantify as well as qualify them and they possess many advantages such as very small sample volume requirement, good precision over entire physiological range, avoid of costly disposables, wealth of information from a single spectral measurement. The efficacy of anti-diabetic drug metformin hydrochloride as used to treat diabetic-induced Wistar rats and their sera were analyzed by FT-IR (ATR) in absorption mode. Materials and Methods: The present work was attempted in the study of normal and antidiabetic regimen-treated rat blood samples using FTIR spectroscopy by the attenuated total reflectance (ATR) sampling technique. The biomolecule characteristics were measured as intensity ratio parameter (IRP) values and interpreted. Results: To quantify the results three IRPs such as R1, R2 and R3 were calculated, respectively, for lipid, protein, and glucose. The glucose IRP value R3 showed, 0.3802, 0.3304, and 0.2847, respectively, for diseased, metformin-treated, and normal rats. Conclusion: The IRP values for glucose are compared to the glucose level obtained by using a glucometer. This study can be conveniently used in diagnostic procedures, patient compliance assessment, and efficacy evaluation of metformin hydrochlorides. PMID:25097400

  6. A clinical evaluation of the ProNOVA XR polymer-free sirolimus eluting coronary stent system in the treatment of patients with de novo coronary artery lesions (EURONOVA XR I study)☆

    PubMed Central

    Legutko, Jacek; Zasada, Wojciech; Kałuża, Grzegorz L.; Heba, Grzegorz; Rzeszutko, Lukasz; Jakala, Jacek; Dragan, Jacek; Klecha, Artur; Giszterowicz, Dawid; Dobrowolski, Wojciech; Partyka, Łukasz; Jayaraman, Swaminathan; Dudek, Dariusz

    2013-01-01

    Aims Evaluation of safety and efficacy of ProNOVA XR, a new generation of polymer-free sirolimus eluting stents (SES), utilizing a pharmaceutical excipient for timed release of sirolimus from the XR platform. Methods and results Safety and efficacy of ProNOVA XR coronary stent system was examined in EURONOVA prospective, single arm, multi-center registry of 50 patients with de novo native coronary lesions up to 28 mm in length in arteries between 2.25 and 4 mm. At 6-month, in-stent late lumen loss by QCA was 0.45 ± 0.41 mm and in-stent neointimal volume obstruction in the IVUS sub-study was 14 ± 11%. One-year clinical follow-up revealed a favorable safety profile, with 2% of in-hospital MACE and 6.4% of MACE from hospital discharge up to 12 months (including 1 cardiac death >30 days after stent implantation and 2 TLRs). According to the ARC definition, there was no definite or probable stent thrombosis and 1 possible stent thrombosis (2%) up to 12 months of clinical follow-up. Conclusions In this preliminary evaluation, ProNOVA XR polymer-free sirolimus eluting stent system appeared safe with an early promise of adequate effectiveness in the treatment of de novo coronary lesions in up to 12 months of clinical, angiographic and IVUS follow-up. PMID:23992999

  7. Clinical performance evaluation of the prototype digital breast tomosynthesis system

    NASA Astrophysics Data System (ADS)

    Kim, Y.; Kim, H.; Park, H.; Choi, J.; Choi, Y.

    2012-03-01

    The rapid development and clinical use of digital mammography in the past decade has made possible the development of digital breast tomosynthesis (DBT), which can overcome the limitation of conventional mammography and improve the specificity of mammography with improved marginal visibility of lesion and early breast cancer detection, especially for women with dense breast. The purpose of this study is to characterize the physical properties of DBT system and to optimize the exposure condition using effective modulation transfer function (eMTF), effective noise power spectrum (eNPS), and effective detective quantum efficiency (eDQE). The first generation KERI prototype digital tomosyntesis system for breast imaging using CMOS flat panel detector was used in this study. It was found that the spatial frequency dependent metrics depend on both the inherent properties of the detector and imaging geometry including breast thickness. For thicker breast, eDQE decreases as scatter fraction increases at fixed tube voltage. Moreover, eMTF shows no significant difference as changing tube voltage while eDQE at 27 kVp is relatively degraded. Consequently, the quantitative evaluation of the DBT system with different exposure condition and breast thickness should be fully considered before building the system and application in clinical hospital.

  8. Clinical evaluation of five electronic root canal length measuring instruments.

    PubMed

    Fouad, A F; Krell, K V; McKendry, D J; Koorbusch, G F; Olson, R A

    1990-09-01

    A previous in vitro study has shown high accuracy, but no clinically significant differences in a group of five electronic root canal length measuring instruments. The purpose of this study was to evaluate and compare the performance of the same group of instruments under clinical conditions and to correlate their accuracy to radiographic estimates of canal length. Five electronic root canal length measuring instruments were used to measure the working length to the "apex" in 20 single-rooted teeth scheduled for extraction. After extraction, the actual canal length was measured visually to a point just within the apical foramen. This length was compared with instrument length as determined electronically. The accuracy of the instruments in determining canal measurement within +/- 0.5 mm from the apical foramen varied from 55 to 75%. The differences between the instruments were not statistically significant. On average, all of the instruments except for the Endocater gave canal length measurements that were beyond the apical foramen. The variability of the measurements, which was comparable to that of estimates of canal length from preoperative radiographs, indicated that radiographic verification of the working length is still desirable. PMID:2098464

  9. Clinical evidence continuous medical education: a randomised educational trial of an open access e-learning program for transferring evidence-based information – ICEKUBE (Italian Clinical Evidence Knowledge Utilization Behaviour Evaluation) – study protocol

    PubMed Central

    Moja, Lorenzo; Moschetti, Ivan; Cinquini, Michela; Sala, Valeria; Compagnoni, Anna; Duca, Piergiorgio; Deligant, Christian; Manfrini, Roberto; Clivio, Luca; Satolli, Roberto; Addis, Antonio; Grimshaw, Jeremy M; Dri, Pietro; Liberati, Alessandro

    2008-01-01

    Background In an effort to ensure that all physicians have access to valid and reliable evidence on drug effectiveness, the Italian Drug Agency sponsored a free-access e-learning system, based on Clinical Evidence, called ECCE. Doctors have access to an electronic version and related clinical vignettes. Correct answers to the interactive vignettes provide Continuing Medical Education credits. The aims of this trial are to establish whether the e-learning program (ECCE) increases physicians' basic knowledge about common clinical scenarios, and whether ECCE is superior to the passive diffusion of information through the printed version of Clinical Evidence. Design All Italian doctors naïve to ECCE will be randomised to three groups. Group one will have access to ECCE for Clinical Evidence chapters and vignettes lot A and will provide control data for Clinical Evidence chapters and vignettes lot B; group two vice versa; group three will receive the concise printed version of Clinical Evidence. There are in fact two designs: a before and after pragmatic trial utilising a two by two incomplete block design (group one versus group two) and a classical design (group one and two versus group three). The primary outcome will be the retention of Clinical Evidence contents assessed from the scores for clinical vignettes selected from ECCE at least six months after the intervention. To avoid test-retest effects, we will randomly select vignettes out of lot A and lot B, avoiding repetitions. In order to preserve the comparability of lots, we will select vignettes with similar, optimal psychometric characteristics. Trial registration ISRCTN27453314 PMID:18637189

  10. Evaluation of Clinical Biomaterial Surface Effects on T Lymphocyte Activation

    PubMed Central

    Rodriguez, Analiz; Anderson, James M.

    2009-01-01

    Previous in vitro studies in our laboratory have shown that lymphocytes can influence macrophage adhesion and fusion on biomaterial surfaces. However, few studies have evaluated how material adherent macrophages can influence lymphocyte behavior, specifically T cells. In this study, we cultured human peripheral blood mononuclear cells from healthy donors on three synthetic non-biodegradable biomedical polymers: Elasthane 80A (PEU), Silicone rubber (SR), or polyethylene terephthalate (PET) and tissue culture polystyrene (TCPS). Upregulation of T cell surface activation markers (CD69 and CD25), lymphocyte proliferation, and interleukin-2 (IL-2) and interferon-γ (IFNγ) concentrations were evaluated by flow cytometry, carboxy-fluorescein diacetate, succinimydyl ester (CFSE) incorporation, and multiplex cytokine immunoassay, respectively, to assess T cell activation. Following 3 and 7 days of culture, CD4+ helper T cells from cultures of any of the material groups did not express the activation markers CD69 and CD25 and lymphocyte proliferation was not present. IL-2 and IFNγ levels were produced, but dependent on donor. These data indicate that T cells are not activated in response to clinically relevant synthetic biomaterials. The data also suggest that lymphocyte subsets exclusive of T cells are the source of the lymphokines, IL-2 and IFN-γ, in certain donors. PMID:19172618

  11. 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…

  12. Clinical and Laboratory Evaluation of Peripheral Prism Glasses for Hemianopia

    PubMed Central

    Giorgi, Robert G.; Woods, Russell L.; Peli, Eli

    2008-01-01

    Purpose Homonymous hemianopia (the loss of vision on the same side in each eye) impairs the ability to navigate and walk safely. We evaluated peripheral prism glasses as a low vision optical device for hemianopia in an extended wearing trial. Methods Twenty-three patients with complete hemianopia (13 right) with neither visual neglect nor cognitive deficit enrolled in the 5-visit study. To expand the horizontal visual field, patients’ spectacles were fitted with both upper and lower Press-On™ Fresnel prism segments (each 40 prism diopters) across the upper and lower portions of the lens on the hemianopic (“blind”) side. Patients were asked to wear these spectacles as much as possible for the duration of the study, which averaged 9 (range: 5 to 13) weeks. Clinical success (continued wear, indicating perceived overall benefit), visual field expansion, perceived direction and perceived quality of life were measured. Results Clinical Success: 14 of 21 (67%) patients chose to continue to wear the peripheral prism glasses at the end of the study (2 patients did not complete the study for non-vision reasons). At long-term follow-up (8 to 51 months), 5 of 12 (42%) patients reported still wearing the device. Visual Field Expansion: Expansion of about 22 degrees in both the upper and lower quadrants was demonstrated for all patients (binocular perimetry, Goldmann V4e). Perceived Direction: Two patients demonstrated a transient adaptation to the change in visual direction produced by the peripheral prism glasses. Quality of Life: At study end, reduced difficulty noticing obstacles on the hemianopic side was reported. Conclusions The peripheral prism glasses provided reported benefits (usually in obstacle avoidance) to 2/3 of the patients completing the study, a very good success rate for a vision rehabilitation device. Possible reasons for long-term discontinuation and limited adaptation of perceived direction are discussed. PMID:19357552

  13. Clinical evaluation of the flotrac/vigileo™ system for continuous cardiac output monitoring in patients undergoing regional anesthesia for elective cesarean section: a pilot study

    PubMed Central

    Auler, José Otavio C.; Torres, Marcelo L. A.; Cardoso, Mônica M.; Tebaldi, Thais C.; Schmidt, André P.; Kondo, Mario M.; Zugaib, Marcelo

    2010-01-01

    BACKGROUND: Spinal anesthesia for cesarean delivery may cause severe maternal hypotension and a decrease in cardiac output. Compared to assessment of cardiac output via a pulmonary artery catheter, the FloTrac/Vigileo™ system may offer a less invasive technique. The aim of this study was to evaluate cardiac output and other hemodynamic measurements made using the FloTrac/Vigileo™ system in patients undergoing spinal anesthesia for elective cesarean section. METHODS: A prospective study enrolling 10 healthy pregnant women was performed. Hemodynamic parameters were continuously obtained at 15 main points: admission to surgery (two baseline measurements), after preload, after spinal anesthesia administration and 4 time points thereafter (4, 6, 8 and 10 min after anesthesia), at skin and uterine incision, newborn and placental delivery, oxytocin administration, end of surgery, and recovery from anesthesia. Hemodynamic therapy was guided by mean arterial pressure, and vasopressors were used as appropriate to maintain baseline values. A repeated measures ANOVA was used for data analysis. RESULTS: There was a significant increase in heart rate and a decrease of stroke volume and stroke volume index up to 10 min after spinal anesthesia (P < 0.01). Importantly, stroke volume variation increased immediately after newborn delivery (P < 0.001) and returned to basal values at the end of surgery. Further hemodynamic parameters showed no significant changes over time. DISCUSSION AND CONCLUSIONS: No significant hemodynamic effects, except for heart rate and stroke volume changes, were observed in pregnant women managed with preload and vasopressors when undergoing elective cesarean section and spinal anesthesia. PMID:20835557

  14. 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 Central

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

    2014-01-01

    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

  15. 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

  16. Treatment of Onychomycosis – a Clinical Study

    PubMed Central

    Pajaziti, Laura; Vasili, Ermira

    2015-01-01

    Introduction: Onychomycosis is a fungal infection of the nail unit. Anatomical and physiological characteristics of the nail apparatus impose the need for long-term treatment to achieve complete cure. Goal: The main goal of this project is to study the effectiveness of several treatment protocols for onychomycosis based on Scoring Clinical Index for Onychomycosis (SCIO). Material and methods: The study included 133 patients with onychomycosis, diagnosed by KOH microscopy and culture. Based on disease severity, patients were grouped into groups with SCIO values: 6-9, and 12-16. These groups were randomly subdivided to 5 subgroups according to the given treatment protocols: fluconazole 150 mg 1x weekly, itraconazole continual therapy, itraconazole pulse therapy, terbinafine 250 mg/d, and terbinafine + ciclopirox 8% lacquer, respectively. The cure rate was evaluated at the end of 48 week. Results: The obtained cure rates according to the above mentioned protocols were: 92.30%, 81.81%, 83.33%, 90.90%, and 100%, respectively for groups of patients with SCIO values 6 – 9. Within patients with SCIO values 12-16, were achieved cure rates as follows: 78.57%, 78.57%, 75%, 80%, and 86.66%. Conclusions: There was no statistically significant difference in cure rate between five treatment protocols applied in this study. In patients with high SCIO values is expected a decrease in cure rate. PMID:26261386

  17. A developmental approach to evaluating competence in clinical reasoning.

    PubMed

    Smith, C Scott

    2008-01-01

    In the past two decades there has been tremendous worldwide interest in assessing the clinical competence of learners in medical education. This interest marks a philosophical shift toward greater objectivity, accountability, and predictive power in the evaluation of trainees. One of the core competencies in medical education is clinical reasoning. Because veterinary and human medical training share several similarities and differences, a review of the current state of clinical reasoning competency assessment in medical education may be useful for veterinary educators. This article covers the core competency of clinical reasoning (not other important competencies, such as physical examination or communication) and reviews research from medical education on the development of clinical reasoning and its implications for the transition from novice to expert. Four common stage-related learner difficulties are described: reduced knowledge, dispersed knowledge, tunnel vision, and the outsider. Specific approaches to measuring competence in clinical reasoning for each developmental level are recommended. Finally, two specific examples of evaluation based on a developmental approach to clinical expertise, the RIME (reporter, interpreter, manager, expert) system and the Script Concordance Test (SCT) methods, are discussed. PMID:19066354

  18. Protected clinical teaching time and a bedside clinical evaluation instrument in an emergency medicine training program.

    PubMed

    Shayne, Philip; Heilpern, Katherine; Ander, Douglas; Palmer-Smith, Victoria

    2002-11-01

    In a process that has evolved over the last four years, the Emory University Emergency Medicine Education Committee has developed an "academic attending" teaching shift incorporating a formatted lecture series with a clinical evaluation exercise (CEE). The program structures the approach to clinical teaching at the bedside, provides an objective clinical evaluation tool specific to emergency medicine residents, and provides targeted learning for medical students and residents rotating in the emergency department (ED). The CEE instrument was designed to be quick and efficient, satisfy requirements of assessment of the Accreditation Council for Graduate Medical Education (ACGME) general competencies, and incorporate the language of the "Model of the Clinical Practice of Emergency Medicine." The original program called for unstructured bedside teaching three days a week, by faculty freed from clinical duties, combined with a limited series of introductory emergency medicine lectures. The program proved more successful when concentrated in a once weekly structured educational program. The prepared, repeating lecture series has been expanded to include many of the most common ED presenting chief complaints and has significantly advanced a curriculum for medical students and visiting interns. A CEE was developed to evaluate and provide immediate feedback to residents on many of the core ACGME competencies. The CEE has been successfully used to structure the bedside educational encounter. This dedicated non-clinical "teaching" shift appears effective in meeting the educational goals of the authors' academic ED. This is a description of the program and its evolution; the program has not been formally evaluated. PMID:12414493

  19. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ..., metabolism, and excretion), and pharmacodynamics (i.e., all of the effects of the drug on various physiologic... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies; Availability AGENCY: Food and Drug Administration,...

  20. Clinical evaluation of thallium-201 SPECT for the detection and differentiation of gliomas: A comparative study with C-11 methionine and F-18 FDG PET

    SciTech Connect

    Sasaki, M.; Ichiya, Y.; Kuwabara, Y.

    1994-05-01

    The aim of this study is to evaluate thallium (Tl)-SPECT in the detection and differentiation of gliomas and then to compare it with the results of methionine (MET)-PET and FDG-PET. We examined 8 patients with gliomas including 3 patients with astrocytoma grade-II, 3 with anaplastic astrocytoma grade-III, 1 with glioblastoma and 1 with malignant oligodendroglioma. A glioblastoma and a malignant oligodendroglioma were grouped together as highly malignant gliomas. The Tl-SPECT images were obtained by GCA9300A 15 minutes after the administration of 148 MBq of thallium. The SPECT images were graded as negative, positive and intensely positive according to the focal thallium uptake in the tumor. Both the MET-PET and FDG-pet were examined by HEADTOME III one hour after the administration of 148-851 MBq of radiopharmaceuticals. Thereafter the standard uptake value (SUV) of MET and FDG were determined. One out of the 3 patients with astrocytoma grade-II and 3 out of the 3 with anaplastic astroycytoma grade-III were positive on Tl-SPECT. Two out of the 2 patients with highly malignant gliomas were intensely positive on Tl-SPECT. The mean SUV of MET for astrocytoma grade-II with negative Tl-SPECT was 0.92, for astrocytoma grade-II with positive Tl-SPECT it was 1.57, for anaplastic astrocytoma grade-III it was 3.02 and for highly malignant glioma it was 3.55. On the other hand, those of FDG were 3.02,4.41,2.25 and 3.70, respectively. In conclusion, Tl-SPECT was found to be as sensitive as MET-PET for detecting gliomas. The grade of Tl accumulation and the SUV of MET demonstrated a positive correlation with the histological grade of gliomas.

  1. [Clinical evaluation CAD/CAM crowns with a natural layering].

    PubMed

    van der Zel, J M; Dekker, J W J M; Balfoort, P W

    2014-02-01

    Around the year 2000, zirconia was introduced in dentistry. It is a material with great strength and attractive aesthetic properties, such as translucency and colour. Recent advances in digital dentistry are aimed at veneering the supporting structure ofzirconia with a layer of glass ceramics by means of an automated process. With the Primero process, a transparent outer layer of glass ceramic is applied directly onto the zirconia core, milled in the green stage and sintered. Because the restorations produced in this way have a two-layer structure like natural teeth, they obtain an aesthetic look similar to natural dental elements. The aim ofthis prospective study was to evaluate fit, marginal adaptation, contact with antagonists and neighbouring dental elements, aesthetics and colour. Clinical performance of Primero restorations were evaluated over a period of6 months and the results were compared with a previous study of CAD/CAM copings which were produced with the same method, but were veneered by hand in the traditional way. PMID:24640297

  2. Clinical evaluation of occlusal glass ionomer, resin, and amalgam restorations.

    PubMed

    Smales, R J; Gerke, D C; White, I L

    1990-10-01

    The purpose of the study was to evaluate four materials (a glass ionomer (polyalkenoate) silver cermet, two composite resin restoratives and a high copper content dental amalgam) placed in either conventional Class I cavities or in modified odontotomy-enameloplasty-sealant (OES) fissure preparations. One experienced operator inserted 438 occlusal. Class I restorations in the posterior permanent teeth of 124 patients in a private dental practice. Restorations were assessed for bulk loss of material, surface voids and cracking, restoration margin fractures and staining, and surface staining and roughness, by using colour transparencies taken at baseline and at recalls for up to 3 years. The glass ionomer cermet was the most difficult material to handle and also gave the least satisfactory clinical result. Loss of material and surface voids were common in the cermet restorations with surface cracking or crazing being seen in 11.4 per cent of the restorations, especially in the larger, conventional Class I preparations. One posterior resin was more viscous and difficult to handle than the other resin and exhibited more surface voids. The amalgam alloy was used in Class I preparations only and showed more restoration margin fractures and surface staining than did the other three materials. However, there were no unsatisfactory clinical assessments given for either restoration margin fracture and staining, or surface staining and roughness for any of the materials. Patient acceptance of the modified OES fissure preparation was extremely good. PMID:2127419

  3. A comparative evaluation of extraction socket preservation with demineralized freeze-dried bone allograft alone and along with platelet-rich fibrin: A clinical and radiographic study

    PubMed Central

    Thakkar, Dhaval J.; Deshpande, Neeraj C.; Dave, Deepak H.; Narayankar, Suraj D.

    2016-01-01

    Aims: To investigate clinically and radiographically, the bone fill in extraction sockets using demineralized freeze-dried bone allograft alone and along with platelet-rich fibrin (PRF). Materials and Methods: A randomized controlled clinical trial was carried out on 36 nonrestorable single-rooted teeth sites. Sites were randomized into demineralized freeze-dried bone allograft (DFDBA) combined with PRF - test and DFDBA - control groups using a coin toss method. After the placement of graft material, collagen membrane was used to cover it. The clinical parameters recorded were ridge width and ridge height. All the parameters were recorded at baseline and at 90 and 180 days. Statistical Analysis Used: Independent t-test and paired t-test. Results: In both groups, there is significant reduction in loss of ridge width and ridge height from baseline to 90 days (P < 0.001), baseline to 180 days (P < 0.001), and 90–180 days (P < 0.001). However, when both the groups were compared the test group favored in the reduction of ridge width while there was no statistical difference in reduction of ridge height among at different intervals. Conclusions: Although DFDBA is considered as an ideal graft material, PRF can be used as an adjunctive with DFDBA for socket preservation.

  4. 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…

  5. [Clinical study on cefprozil in pediatrics].

    PubMed

    Iwai, N; Miyazu, M; Nakamura, H; Kasai, K

    1992-11-01

    Clinical efficacy and safety of cefprozil (CFPZ, BMY-28100), a newly developed oral cephalosporin, were studied in our pediatric department. Clinical effectiveness, bacteriological effectiveness and side effects were studied in 116 pediatric patients with ages ranging 4 months to 11 years. CFPZ was given 4.6-14.1 mg/kg daily in 3 times for 3-10 days. Clinical efficacies were evaluated in 112 patients, and the therapeutic effectiveness were excellent in 1 and good in 6 for 7 patients with acute pharyngitis, excellent in 24 and good in 26 for acute purulent tonsillitis, excellent in 3, good in 8 and fair in 1 for acute bronchitis, excellent in 21, good in 7, fair in 1 and poor in 1 for acute pneumonia, excellent in 1 acute purulent parotitis, excellent in 2 and good in 7 for acute UTI, good in 1 impetigo, fair in 1 periproctal abscess and good in 1 acute enteritis. The effectiveness rate was 96.4%. Bacteriologically, 4 strains of Staphylococcus aureus (beta-lactamase producing strains), 1 strain of Staphylococcus epidermidis (beta-lactamase producing strain), 2 strains of Streptococcus pneumoniae, 2 strains of Streptococcus agalactiae, 4 strains of beta-Streptococcus, 1 strain of Klebsiella pneumoniae (beta-lactamase producing strain) and 1 strain of Salmonella C2 were all disappeared, and of 22 strains of Streptococcus pyogenes, 20 strains were disappeared, 1 was decreased and 1 was unknown, of 5 strains of Escherichia coli (3 beta-lactamase producing strains), 4 were disappeared and 1 was decreased, of 29 strains of Haemophilus influenzae (14 beta-lactamase producing strains), 14 were disappeared, 11 were decreased, 3 persisted and 1 was unknown and of 2 strains of Haemophilus parainfluenzae (1 beta-lactamase producing strain), 1 was disappeared and 1 persisted. The bacteriological eradication rates for Gram-positive bacteria and Gram-negative bacteria were 97.1% and 56.8%, respectively, and the drug was especially effective against Gram-positive bacteria. No side

  6. Clinical study of the stunned myocardium.

    PubMed

    Sone, T; Tsuboi, H; Sassa, H

    1991-09-01

    Clinical features of 37 cases of stunned myocardium were studied. Mean duration of asynergy was 22.6 +/- 15.7 days. In all 11 cases of unstable angina without any significant serum creatine kinase leakage, the duration of asynergy was within 14 days. Related coronary lesions were reperfused (spontaneously or by interventional therapy) to TIMI grade II or higher. Transient Q waves were observed in 39% of all cases. Negative T waves tended to be prolonged, and persisted after disappearance of asynergy in 74% of all cases. 201Tl uptake in the stunned area varied widely between individual cases (ranging from "absent" to "normal"), although it became normal in all cases in the chronic stage. Mal-distribution of 99mTc-pyrophosphate (PYP) to the endocardial side of the stunned area was observed in 33%. In 186 cases of acute coronary syndrome, we studied whether or not reversibility of ischemia-disturbed myocardium could be predicted by simultaneous dual isotope SPECT, and found that 201Tl-uptake in the chronic stage significantly improved in the region showing absence of 99mTc-PYP accumulation or maldistribution of 99mTc-PYP to the endocardial side, while reversibility of the region showing transmural 99mTc-PYP accumulation and a dought pattern was poor. Ischemia-associated myocardial damage recovered to various degrees, and dual isotope SPECT was useful in evaluating the reversibility of such damage already at the acute stage. PMID:1834873

  7. The Varicocele: Clinical Presentation, Evaluation, and Surgical Management.

    PubMed

    Lomboy, Jason R; Coward, Robert M

    2016-09-01

    A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility. Varicoceles are also often incidental findings on imaging studies, particularly scrotal ultrasound. Importantly, not all varicoceles should be treated equally (or at all), and basic guidelines on the evaluation and indications for treatment of adult varicoceles should be reviewed before counseling and treatment. A semen analysis should be obtained for any male patient of reproductive age considering intervention. The adolescent varicocele is managed much differently than the adult varicocele and remains a source of controversy. This review describes the clinical presentation and the evaluation of adult and pediatric varicoceles, and provides guidance on their diagnosis and workup. It also describes options for surgical repair and the success and complication rates associated with each surgical approach, ultimately supporting microsurgical subinguinal varicocele repair as the current surgical standard. PMID:27582602

  8. Development of an Evaluative Procedure for Clinical Clerkships.

    ERIC Educational Resources Information Center

    And Others; Pancorbo, Salvador

    1980-01-01

    In order to evaluate the clinical competencies of graduate pharmacy students upon the completion of a medicine rotation, an oral examination has been developed that requires students to present data and defend decisions. Objectives, responsibilities, and competencies required by the rotation and nine sample exam questions are appended. (JMD)

  9. ASSESSMENT OF CLINICAL PROCEDURES TO EVALUATE LIVER INTOXICATION IN FISH

    EPA Science Inventory

    Procedures were developed to clinically evaluate liver damage and liver function in rainbow trout following either acute intraperitoneal (i.p.) treatment or subacute bath exposure to selected mammalian hepatotoxic agents. Elevations in serum of liver specific enzymes such as aspa...

  10. 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…

  11. Considered Evaluation of Clinical Placements in a New Medical School

    ERIC Educational Resources Information Center

    Booth, Jerry; Collins, Sarah; Hammond, Anna

    2009-01-01

    This article suggests that quality assessment in the UK has been largely set apart from learning and teaching and reports on a pilot project at the Hull York Medical School which attempted to integrate students' evaluation of their clinical placements into the curriculum. It outlines the operational demands of this integrated method and compares…

  12. One-year clinical evaluation of bonded amalgam restorations.

    PubMed

    Mahler, D B; Engle, J H; Simms, L E; Terkla, L G

    1996-03-01

    Using one selected amalgam bonding agent, the authors evaluated bonded and unbonded restorations in clinical service. Based on postoperative sensitivity one to two weeks after placement and marginal fracture at one year, no difference was found between the bonded and unbonded restorations. Furthermore, some technical difficulties were experienced with use of the bonding agent. PMID:8819781

  13. 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

  14. 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…

  15. Uremic pruritus. Clinical and experimental studies.

    PubMed

    Ståhle-Bäckdahl, M

    1989-01-01

    The aim of the study was to investigate clinical aspects of pruritus in maintenance hemodialysis patients and to evaluate factors of putative pathogenic importance. 60-65% of the patients in a maintenance hemodialysis program during a two-year period suffered from itching. Patients with pruritus tended to have been on dialysis treatment longer than those without pruritus (p = 0.05), otherwise there was no difference in clinical data or routine laboratory tests. Measurement of itch intensity continuously over one week in 28 patients using a computerized method showed that itching peaked at night after two days without dialysis, was relatively high during treatment and lowest during the day following dialysis. Our results suggest that the accumulation of pruritogens between dialysis sessions influences the intensity of itching. Most patients had "dry" skin. Recording of the stratum corneum water content by measurement of electrical capacitance, in 31 patients (19 with pruritus) and 12 controls, disclosed no significant difference between dialysis patients and controls, but a tendency that pruritic patients had a lower water content than the other subjects. In different body areas, there was a positive correlation in all groups between the clinical estimation of xerosis and hydration. Serum concentrations of parathyroid hormone (PTH) were significantly higher in dialysis patients with pruritus than in those without, but there was no correlation between the degree of symptoms and the PTH level. Indirect immunohistochemistry revealed no immunoreactivity for different parts of the PTH molecule in skin biopsies from uremic patients. Intradermal injections of PTH fragments did not evoke itching or other cutaneous reactions in patients or controls. Our results do not support PTH as a peripheral mediator of uremic itching. Flare reactions induced by intradermal histamine injections were significantly smaller in 26 dialysis patients (18 with pruritus) than in 9 healthy

  16. 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 developed.…

  17. 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

  18. 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. PMID:27107246

  19. Computational mitral valve evaluation and potential clinical applications.

    PubMed

    Chandran, Krishnan B; Kim, Hyunggun

    2015-06-01

    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 structural analysis and fluid-structure interaction 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

  20. 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

  1. Evaluation Guidelines for the Clinical and Translational Science Awards (CTSAs)

    PubMed Central

    Trochim, William M.; Rubio, Doris M.; Thomas, Veronica G.

    2014-01-01

    The National Center for Advancing Translational Sciences (NCATS), a part of the National Institutes of Health, currently funds the Clinical and Translational Science Awards (CTSAs), a national consortium of 61 medical research institutions in 30 states and the District of Columbia. The program seeks to transform the way biomedical research is conducted, speed the translation of laboratory discoveries into treatments for patients, engage communities in clinical research efforts, and train a new generation of clinical and translational researchers.. An endeavor as ambitious and complex as the CTSA program requires high-quality evaluations in order to show that the program is well implemented, efficiently managed, and demonstrably effective. In this article, the Evaluation Key Function Committee of the CTSA Consortium presents an overall framework for evaluating the CTSA program and offers policies to guide the evaluation work. The guidelines set forth are designed to serve as a tool for education within the CTSA community by illuminating key issues and practices that should be considered during evaluation planning, implementation, and utilization. Additionally, these guidelines can provide a basis for ongoing discussions about how the principles articulated in this article can most effectively be translated into operational reality. PMID:23919366

  2. Translating diagnostic assays from the laboratory to the clinic: analytical and clinical metrics for device development and evaluation.

    PubMed

    Borysiak, Mark D; Thompson, Matthew J; Posner, Jonathan D

    2016-04-21

    As lab-on-a-chip health diagnostic technologies mature, there is a push to translate them from the laboratory to the clinic. For these diagnostics to achieve maximum impact on patient care, scientists and engineers developing the tests should understand the analytical and clinical statistical metrics that determine the efficacy of the test. Appreciating and using these metrics will benefit test developers by providing consistent measures to evaluate analytical and clinical test performance, as well as guide the design of tests that will most benefit clinicians and patients. This paper is broken into four sections that discuss metrics related to general stages of development including: (1) laboratory assay development (analytical sensitivity, limit of detection, analytical selectivity, and trueness/precision), (2) pre-clinical development (diagnostic sensitivity, diagnostic specificity, clinical cutoffs, and receiver-operator curves), (3) clinical use (prevalence, predictive values, and likelihood ratios), and (4) case studies from existing clinical data for tests relevant to the lab-on-a-chip community (HIV, group A strep, and chlamydia). Each section contains definitions of recommended statistical measures, as well as examples demonstrating the importance of these metrics at various stages of the development process. Increasing the use of these metrics in lab-on-a-chip research will improve the rigor of diagnostic performance reporting and provide a better understanding of how to design tests that will ultimately meet clinical needs. PMID:27043204

  3. 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

  4. A clinical evaluation of a novel toothbrush design.

    PubMed

    Kieser, J; Groeneveld, H

    1997-06-01

    A new toothbrush design, the Snakebrush, was clinically evaluated along with the Flexible and Precision brushes. In this parallel, random-allocation investigation, the plaque removing qualities of the 3 brushes were evaluated over a period of 30 days. 60 patients of good dental health between the ages of 20 and 30 years formed the basis of the clinical trial. Mean plaque area scores were evaluated and recorded after a 1-min brush at baseline, day 15 and day 30. Gingivitis indices and bleeding on probing indices were also recorded at the same time intervals. Both uni- and multivariate analyses of our data suggested that the Snakebrush removed significantly more plaque than the 2 controls. For both lingual and buccal surfaces, subjects who had used the Snakebrush showed a significant decline in bleeding on probing and qinqivitis indices. PMID:9205921

  5. Relating clinical study design to basic research.

    PubMed

    Choh, V; Priolo, S

    1999-07-01

    Devising any research study involves careful attention to its design, as well as the development of an appropriate research question and hypothesis. Together, these attributes ensure the validity of the study in question. In most clinical or epidemiological studies, the types of research designs are often explicitly noted, whereas in papers describing basic or biological research, they are couched in different terms or, more often, are ignored, thus potentially hindering communication between basic and clinical researchers. However, given that the framework for all valid scientific research is based on sound logic, it is proposed that for each study design, a direct homology exists between clinical and basic research paradigms, despite the problem of relating epidemiological vernacular to basic research. By applying examples of basic research protocols to traditional clinical study designs, this paper shows that parallels can be drawn between the two strategies, suggesting that in the absence of a conventional nomenclature to describe basic research study designs, the use of traditional clinical design jargon is valid in describing basic research protocols. PMID:10445637

  6. 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…

  7. Penile dermatoses: a clinical and histopathological study.

    PubMed Central

    Hillman, R J; Walker, M M; Harris, J R; Taylor-Robinson, D

    1992-01-01

    OBJECTIVE--To assess the spectrum of genital dermatological conditions affecting men and compare the clinical and histopathological diagnoses. DESIGN--Prospective study over a one year period. SETTING--A central London teaching hospital. PATIENTS--Seventy one patients with unresponsive penile dermatoses attending a specific internal referral clinic within the department of genitourinary medicine and 36 patients undergoing penile biopsy following attendance at other departments within the same hospital. METHODS--Full dermatological assessment of patients attending the specific clinic. Standard histopathological methods were used in the diagnosis of biopsy specimens. OUTCOME MEASURED--Clinico-pathological diagnosis of cutaneous penile abnormalities. RESULTS--Description of the range and relative frequency of penile dermatological conditions. The most common histopathological diagnosis was of non specific dermatitis. Twenty seven percent (16 of 61) of patients attending the specific clinic and 33% (12 of 36) of men attending other departments had conditions requiring long term follow up. CONCLUSIONS--The ranges of penile dermatoses presenting to the different departments were broadly similar. Penile biopsy was shown to be a safe and clinically informative procedure. In the genitourinary clinic setting, clinical diagnosis prior to biopsy was found frequently to be inaccurate. Images PMID:1607192

  8. Assessment of mutagenic effect of G. acerosa and S. wightii in S. typhimurium (TA 98, TA 100, and TA 1538 strains) and evaluation of their cytotoxic and genotoxic effect in human mononuclear cells: a non-clinical study.

    PubMed

    Syad, Arif Nisha; Kasi, Pandima Devi

    2014-01-01

    The marine red algae (Gelidiella acerosa and Sargassum wightii) possessing excellent antioxidant and anticholinesterase activity were subjected to toxicity evaluation for a deeper understanding of other bioprotective properties of seaweeds. Cytotoxic evaluation was done by trypan blue exclusion, and MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) assays using human PBMC (peripheral blood mononuclear cells) and RBC (red blood cells) lysis assay using human erythrocytes. Mutagenicity of the seaweeds was analyzed by Ames salmonella mutagenicity test with the histidine dependent mutant strains TA 98, TA100 and TA 1538. Genotoxic activity was verified in PBMC by comet assay. The results suggest that benzene extract of G. acerosa (BEGA) and dichloromethane extract of S. wightii (DMESW) did not show cytotoxic effect both in PBMC and erythrocytes. Evaluation of mutagenic activity suggests that the seaweeds did not cause any mutagenic effects both in the absence and the presence of S9 microsomal fraction in all the three Salmonella mutant strains. Results of genotoxic study showed that PBMC treated with seaweed extracts (1 mg/mL) exhibit less or no damage to cells, thus proving the non-genotoxic effect of the extract. Since these in vitro non-clinical studies clearly demonstrate the non-toxic nature of the seaweeds, they could be exploited for further characterization, which would result in development of novel and safe therapeutic entities. PMID:24967353

  9. Evaluating clinical teachers: does the learning environment matter?

    PubMed

    Myers, K A

    2001-03-01

    Teaching evaluations are an important part of promotion reviews. This study of the effect of learning environment on evaluations found ratings from students in ambulatory settings were higher than were those from inpatient settings. PMID:11242584

  10. 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. PMID:19883529

  11. Embedding clinical interventions into observational studies.

    PubMed

    Newman, Anne B; Avilés-Santa, M Larissa; Anderson, Garnet; Heiss, Gerardo; Howard, Wm James; Krucoff, Mitchell; Kuller, Lewis H; Lewis, Cora E; Robinson, Jennifer G; Taylor, Herman; Treviño, Roberto P; Weintraub, William

    2016-01-01

    Novel approaches to observational studies and clinical trials could improve the cost-effectiveness and speed of translation of research. Hybrid designs that combine elements of clinical trials with observational registries or cohort studies should be considered as part of a long-term strategy to transform clinical trials and epidemiology, adapting to the opportunities of big data and the challenges of constrained budgets. Important considerations include study aims, timing, breadth and depth of the existing infrastructure that can be leveraged, participant burden, likely participation rate and available sample size in the cohort, required sample size for the trial, and investigator expertise. Community engagement and stakeholder (including study participants) support are essential for these efforts to succeed. PMID:26611435

  12. Anatomical study of the submandibular gland duct after removal of a distal stone without sialodochoplasty: a sialographic evaluation of a clinical phase II trial.

    PubMed

    Woo, Seung Hoon; Kwon, Min Su; Park, Jung Je; Kim, Jin Pyeong

    2016-06-01

    Transoral removal of a distal salivary stone is common. We have used postoperative sialography to evaluate the results and changes in the salivary ducts after removal of a salivary distal stone without sialodochoplasty. Of 20 patients who had had transoral operations for submandibular stones, 19 recovered normally with no recurrence. One developed partial stenosis and one a spontaneous neo-opening as a result of severe adhesions and inflammation between the salivary stone and the duct. None of the patients had any symptoms of recurrence during the 12-month follow-up. Sialodochoplasty may not be necessary in patients who have had a distal salivary stone removed. Removal without sialodochoplasty resulted in full anatomical recovery of the salivary ducts. PMID:26975573

  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. Economic evaluation in long-term clinical trials.

    PubMed

    Hlatky, Mark A; Boothroyd, Derek B; Johnstone, Iain M

    2002-10-15

    Economic endpoints have been increasingly included in long-term clinical trials, but they pose several methodologic challenges, including how best to collect, describe, analyse and interpret medical cost data. Cost of care can be measured by converting billed charges, performing detailed micro-costing studies, or by measuring use of key resources and assigning cost weights to each resource. The latter method is most commonly used, with cost weights based either on empirical regression models or administratively determined reimbursement rates. In long-term studies, monetary units should be adjusted to reflect cost inflation and discounting. The temporal pattern of accumulating costs can be described using a modification of the Kaplan-Meier curve. Regression analyses to evaluate factors associated with cost are best performed on the log of costs due to their typically skewed distribution.Cost-effectiveness analysis attempts to measure the value of a new therapy by calculating the difference in cost between the new therapy and the standard therapy, divided by the difference in benefit between the new therapy and the standard therapy. The cost-effectiveness ratio based on the results of a randomized trial may change substantially with longer follow-up intervals, particularly for therapies that are initially expensive but eventually improve survival. A model that projects long-term patterns of cost and survival expected beyond the end of completed follow-up can provide an important perspective in the setting of limited trial duration. PMID:12325104

  15. 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

  16. 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;…

  17. Systematic Review and Meta-Analysis of Studies Evaluating Diagnostic Test Accuracy: A Practical Review for Clinical Researchers-Part II. Statistical Methods of Meta-Analysis.

    PubMed

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

    2015-01-01

    Meta-analysis of diagnostic test accuracy studies differs from the usual meta-analysis of therapeutic/interventional studies in that, it is required to simultaneously analyze a pair of two outcome measures such as sensitivity and specificity, instead of a single outcome. Since sensitivity and specificity are generally inversely correlated and could be affected by a threshold effect, more sophisticated statistical methods are required for the meta-analysis of diagnostic test accuracy. Hierarchical models including the bivariate model and the hierarchical summary receiver operating characteristic model are increasingly being accepted as standard methods for meta-analysis of diagnostic test accuracy studies. We provide a conceptual review of statistical methods currently used and recommended for meta-analysis of diagnostic test accuracy studies. This article could serve as a methodological reference for those who perform systematic review and meta-analysis of diagnostic test accuracy studies. PMID:26576107

  18. 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

  19. An evaluation of computer assisted clinical classification algorithms.

    PubMed

    Chute, C G; Yang, Y; Buntrock, J

    1994-01-01

    The Mayo Clinic has a long tradition of indexing patient records in high resolution and volume. Several algorithms have been developed which promise to help human coders in the classification process. We evaluate variations on code browsers and free text indexing systems with respect to their speed and error rates in our production environment. The more sophisticated indexing systems save measurable time in the coding process, but suffer from incompleteness which requires a back-up system or human verification. Expert Network does the best job of rank ordering clinical text, potentially enabling the creation of thresholds for the pass through of computer coded data without human review. PMID:7949912

  20. 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.

  1. Sample sizes in dosage investigational clinical trials: a systematic evaluation.

    PubMed

    Huang, Ji-Han; Su, Qian-Min; Yang, Juan; Lv, Ying-Hua; He, Ying-Chun; Chen, Jun-Chao; Xu, Ling; Wang, Kun; Zheng, Qing-Shan

    2015-01-01

    The main purpose of investigational phase II clinical trials is to explore indications and effective doses. However, as yet, there is no clear rule and no related published literature about the precise suitable sample sizes to be used in phase II clinical trials. To explore this, we searched for clinical trials in the ClinicalTrials.gov registry using the keywords "dose-finding" or "dose-response" and "Phase II". The time span of the search was September 20, 1999, to December 31, 2013. A total of 2103 clinical trials were finally included in our review. Regarding sample sizes, 1,156 clinical trials had <40 participants in each group, accounting for 55.0% of the studies reviewed, and only 17.2% of the studies reviewed had >100 patient cases in a single group. Sample sizes used in parallel study designs tended to be larger than those of crossover designs (median sample size 151 and 37, respectively). In conclusion, in the earlier phases of drug research and development, there are a variety of designs for dosage investigational studies. The sample size of each trial should be comprehensively considered and selected according to the study design and purpose. PMID:25609916

  2. 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

  3. 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. PMID:23116307

  4. Head Start Evaluation and Research Center, Boston University. Report B-I, Primary and Secondary Prevention Studying Clinical Process and Disturbance with Preschool Children.

    ERIC Educational Resources Information Center

    Fish, Caroline; And Others

    Two groups of preschool children from the Boston area were selected to participate in a study of marginal emotional disorders, their diagnosis by an interdisciplinary team, and their effect upon a child's functioning in the preschool setting. The two groups of children who attended the diagnostic sessions consisted of 19 lower class Head Start…

  5. Evaluating the effects of cognitive support on psychiatric clinical comprehension

    PubMed Central

    Dalai, Venkata V.; Khalid, Sana; Gottipati, Dinesh; Kannampallil, Thomas; John, Vineeth; Blatter, Brett; Patel, Vimla L.; Cohen, Trevor

    2014-01-01

    Objective Clinicians’ attention is a precious resource, which in the current healthcare practice is consumed by the cognitive demands arising from complex patient conditions, information overload, time pressure, and the need to aggregate and synthesize information from disparate sources. The ability to organize information in ways that facilitate the generation of effective diagnostic solutions is a distinguishing characteristic of expert physicians, suggesting that automated systems that organize clinical information in a similar manner may augment physicians’ decision-making capabilities. In this paper, we describe the design and evaluation of a theoretically driven cognitive support system (CSS) that assists psychiatrists in their interpretation of clinical cases. The system highlights, and provides the means to navigate to, text that is organized in accordance with a set of diagnostically and therapeutically meaningful higher-level concepts. Methods and Materials To evaluate the interface, 16 psychiatry residents interpreted two clinical case scenarios, with and without the CSS. Think-aloud protocols captured during their interpretation of the cases were transcribed and analyzed qualitatively. In addition, the frequency and relative position of content related to key higher-level concepts in a verbal summary of the case were evaluated. In addition the transcripts from both groups were compared to an expert derived reference standard using latent semantic analysis (LSA). Results Qualitative analysis showed that users of the system better attended to specific clinically important aspects of both cases when these were highlighted by the system, and revealed ways in which the system mediates hypotheses generation and evaluation. Analysis of the summary data showed differences in emphasis with and without the system. The LSA analysis suggested users of the system were more “expert-like” in their emphasis, and that cognitive support was more effective in the

  6. Ebola virus disease candidate vaccines under evaluation in clinical trials.

    PubMed

    Martins, Karen A; Jahrling, Peter B; Bavari, Sina; Kuhn, Jens H

    2016-09-01

    Filoviruses are the etiological agents of two human illnesses: Ebola virus disease and Marburg virus disease. Until 2013, medical countermeasure development against these afflictions was limited to only a few research institutes worldwide as both infections were considered exotic due to very low case numbers. Together with the high case-fatality rate of both diseases, evaluation of any candidate countermeasure in properly controlled clinical trials seemed impossible. However, in 2013, Ebola virus was identified as the etiological agent of a large disease outbreak in Western Africa including almost 30,000 infections and more than 11,000 deaths, including case exportations to Europe and North America. These large case numbers resulted in medical countermeasure development against Ebola virus disease becoming a global public-health priority. This review summarizes the status quo of candidate vaccines against Ebola virus disease, with a focus on those that are currently under evaluation in clinical trials. PMID:27160784

  7. Patterns of injuries in athletes evaluated in an interdisciplinary clinic.

    PubMed

    Frontera, W R; Micheo, W F; Amy, E; Meléndez, E; Aguirre, G; Correa, J J; Camuñas, J F

    1994-09-01

    The pattern of sports injuries appears to be population-specific. The purpose of the present study is to describe 1750 injuries evaluated between April 1988 and April 1994 in our Olympic Training Center Interdisciplinary Sports Injury Clinic. Our patient population included elite and recreational athletes of both sexes between the ages of 7 and 71 years. Males comprised 73% of the patient population and approximately 80% of the injuries corresponded to the 10 to 29 age range. The most frequent sports in males were baseball (21.9%) and basketball (15.9%) and in females were track and field (17.1%) and gymnastics (15.1%). Most injuries (52%) were traumatic in nature, chronic (71.6%), and occurred during training sessions (57.4%). The most commonly affected anatomical areas were the knee (31.2%) and shoulder (15.5%). The most common diagnoses were tendinitis (25.4%), and first degree strains (11.8%) and sprains (9.3%). Finally, treatment strategies included medications (61.0%), physical therapy (48.9%), relative rest (35.7%), and home exercise programs (35.2%). The variety of musculoskeletal disorders seen in combination with the frequent use of conservative treatment confirms the importance of an interdisciplinary approach to sports injuries. PMID:7997497

  8. 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

  9. 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

  10. Clinical evaluation of GEM 21S® and a collagen membrane with a coronally advanced flap as a root coverage procedure in the treatment of gingival recession defects: A comparative study

    PubMed Central

    Singh, Preetinder; Suresh, D. K.

    2012-01-01

    Aim: Clinical evaluation of efficacy of rhPDGF-BB plus beta tricalcium phosphate (GEM 21S®) along with a collagen membrane in root coverage using a coronally advanced flap. Materials and Methods: This human case series evaluated the clinical outcome of rhPDGF-BB with beta-tricalcium phosphate (GEM 21S®) and a collagen membrane in the treatment of recession defects using a coronally advanced flap. Patients were followed postoperatively, and healing was evaluated at 1, 3, and 6 months, with recession depth as the primary outcome measure. Results: This pioneer case series revealed a favorable tissue response to GEM 21S® and collagen membrane from both clinical and esthetic point of view in regenerative periodontal surgery. PMID:23493720

  11. Two Years Later: Former Students' Perceptions of a Clinical Evaluation Course and Current Evaluation Practices

    ERIC Educational Resources Information Center

    Staudt, Marlys M.

    2007-01-01

    The Council on Social Work Education accreditation standards requires that the social work curricula include content on practice evaluation. To meet this requirement, many schools have a course devoted to clinical evaluation. The desired outcome of these courses is that students not only learn the content but also retain it and implement…

  12. 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. PMID:8836924

  13. Humanizing Oral Health Care through Continuing Education on Social Determinants of Health: Evaluative Case Study of a Canadian Private Dental Clinic.

    PubMed

    Lévesque, Martine; Levine, Alissa; Bedos, Christophe

    2016-01-01

    Primary care practitioners are frequently unprepared to take into account the effects of social determinants on underprivileged patients' health and health management. To address this issue among dental professionals, an original onsite continuing education (CE) course on poverty was co-developed by researchers, dental professionals, and community organizations. Integrating patient narratives and a short film, course material aims to elicit critical reflection and provide coaching for practice improvements. A qualitative case study conducted with a large Montreal Canada dental team reveals CE course participants' newfound understandings and increased sensitivity to the causes of poverty and the nature of life on welfare. Participants also describe revised interpretations of certain patient behaviors, subtle changes in communication with patients and improved equity in appointment-giving policy. Unintended outcomes include reinforced judgment and a tendency to moralize certain patient categories. Implications for health professional educators, researchers, and dental regulatory authorities are discussed. PMID:27524746

  14. Clinical evaluation of the efficacy and safety of a medical device in various forms containing Triticum vulgare for the treatment of venous leg ulcers - a randomized pilot study.

    PubMed

    Romanelli, Marco; Macchia, Michela; Panduri, Salvatore; Paggi, Battistino; Saponati, Giorgio; Dini, Valentina

    2015-01-01

    This study was carried out to assess the efficacy and tolerability of the topical application of an aqueous extract of Triticum vulgare (TV) in different vehicles (cream, impregnated gauzes, foam, hydrogel, and dressing gel) for the treatment of venous lower leg ulcers. Fifty patients were randomized to receive one of the five investigational vehicles. Treatment was performed up to complete healing or to a maximum of 29 days. The wound size reduction from baseline was the primary efficacy variable, which was measured by means of a noninvasive laser scanner instrument for wound assessment. In all groups, apart from the foam group, a similar trend toward the reduction of the surface area was observed. The cream showed the greatest effect on the mean reduction of the lesion size. At last visit, six ulcers were healed: two in the cream group, three in the gauze group, and one in the dressing gel group. In the patients treated with the cream, the gauzes, the hydrogel, and the dressing gel, the reduction of lesion size was 40%-50%; the reduction was smaller in the foam group. No impact in terms of age on the healing process was found. The Total Symptoms Score decreased in all groups during the study; a greater efficacy in terms of signs/symptoms was observed in the patients treated with the gauzes. In the dressing gel group, one patient had an infection of the wound after 3 weeks of treatment and 2 of colonization, leading to a systemic antibiotic treatment. The events were judged as nonrelated to the device used. On the basis of the results, it could be argued that the medical device may be useful in the treatment of chronic venous ulcers. PMID:26060395

  15. 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

  16. 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

  17. Musculoskeletal demands on flamenco dancers: a clinical and biomechanical study.

    PubMed

    Bejjani, F J; Halpern, N; Pio, A; Dominguez, R; Voloshin, A; Frankel, V H

    1988-04-01

    The flamenco dancer acts on the floor like a drummer. The percussive footwork and vibration patterns created during dancing impose unusual demands on the musculoskeletal system. This study investigated the clinical and biomechanical aspects of this task. Using the electrodynogram and skin-mounted accelerometers, foot pressures as well as hip and knee vibrations were recorded in 10 female dancers after a thorough clinical evaluation. A health questionnaire was also distributed to 29 dancers. Foot pressures and acceleration data reveal the percussive nature of the dance. Some clinical findings, like calluses, are related to pressure distribution. Urogenital disorders, as well as back and neck pain, may be related to the vibrations generated by the flamenco dance form. The hip joint seems to absorb most of the impacts. "Vibration-pressure" diagrams are suggested as a useful tool for evaluating a dancer's biomechanical behavior, as well as the effect of floors and footwear on this behavior. PMID:3366430

  18. 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

  19. Case Studies: Windows onto Clinical Supervision.

    ERIC Educational Resources Information Center

    Nolan, Jim; And Others

    1993-01-01

    By examining the structures and activities common to six case studies of clinical teacher supervision, this article identifies five conditions that facilitate changes in teacher thinking and behavior: development of a supportive, collegial relationship; teacher control over supervision products; continuity over time; focused, descriptive records…

  20. Naturalistic Study of Evaluation Utilization.

    ERIC Educational Resources Information Center

    Alkin, Marvin C.

    1980-01-01

    Case studies of educational program evaluations demonstrate that utilization of evaluative information occurs; however, its forms and the forces influencing utilization are complex. Naturalistic methods were used to study utilization. (See RIE: ED 174 666). (Available from: Jossey-Bass, Inc., 433 California St., San Francisco, CA 94104, single…

  1. Clinical evaluation of the Sorin Xtra® autotransfusion system

    PubMed Central

    Lanen, PWJ; Feron, JCM; van Hees, JWH; Tan, MESH

    2012-01-01

    The performance of the Sorin Xtra® Autotransfusion System (ATS) was studied in 62 patients undergoing coronary artery bypass grafting. Blood was collected intraoperatively and washed using three different wash sets in 4 groups. Both collected and washed blood were analysed for hemoglobin levels and hematocrit, concentrations of proteins, albumin, heparin and plasma free hemoglobin (PFH) were determined, erythrocytes, platelets and leukocytes were counted. Hematocrit measurements of the Xtra® were compared with laboratory measurements to study the accuracy of the Xtra® hematocrit sensor. In addition, the red blood cell recovery rate and elimination rates were calculated to evaluate the clinical performance of the Xtra®. The Xtra® ATS produced a volume of concentrated red blood cells with an average hematocrit from 58% to 63%, depending on the size of the bowl and the chosen default program. In all bowl sizes and programs, the Xtra® Hct-out measurement underestimated the CELL-DYN measurement by approximately 15%. The calculated recovery rates for red blood cells (RBC) in the 4 groups ranged from 86.7% to 91.6%. Elimination rates were calculated in each group for proteins (96.8-99.2%), albumin (96.4-98.7%), plasma free hemoglobin (83.6–91.2%), heparin (98.8-99.9%), platelets (82.4-94.3%) and white blood cells (28.6-42.3%). The Xtra® ATS can be appealing for its performance by producing high hematocrit levels in the washed RBC volume, while keeping RBC recovery rate at the same high level (≈ 90%) as in its predecessor, the Electa® Autotransfusion System. PMID:22460925

  2. 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

  3. 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…

  4. An R package for simulation experiments evaluating clinical trial designs.

    PubMed

    Wang, Yuanyuan; Day, Roger

    2010-01-01

    This paper presents an open-source application for evaluating competing clinical trial (CT) designs using simulations. The S4 system of classes and methods is utilized. Using object-oriented programming provides extensibility through careful, clear interface specification; using R, an open-source widely-used statistical language, makes the application extendible by the people who design CTs: biostatisticians. Four key classes define the specifications of the population models, CT designs, outcome models and evaluation criteria. Five key methods define the interfaces for generating patient baseline characteristics, stopping rule, assigning treatment, generating patient outcomes and calculating the criteria. Documentation of their connections with the user input screens, with the central simulation loop, and with each other faciliates the extensibility. New subclasses and instances of existing classes meeting these interfaces can integrate immediately into the application. To illustrate the application, we evaluate the effect of patient pharmacokinetic heterogeneity on the performance of a common Phase I "3+3" design. PMID:21347151

  5. 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…

  6. Using Multiple Assessments to Evaluate Medical Students' Clinical Ability in Psychiatric Clerkships

    ERIC Educational Resources Information Center

    Wang, Peng-Wei; Cheng, Cheng-Chung; Chou, Frank Huang-Chih; Tsang, Hin-Yeung; Chang, Yu-San; Huang, Mei-Feng; Yen, Cheng-Fang

    2011-01-01

    Background: No single assessment method can successfully evaluate the clinical ability of medical students in psychiatric clerkships; however, few studies have examined the efficacy of multiple assessments, especially in psychiatry. The aim of this study was to examine the relationship among different types of assessments of medical students'…

  7. A Prospective, Comparative, Evaluator-blind Clinical Study Investigating Efficacy and Safety of Two Injection Techniques with Radiesse® for the Correction of Skin Changes in Aging Hands

    PubMed Central

    Gubanova, Elena I; Starovatova, Polina A

    2015-01-01

    Background: Dermal fillers are used to correct age-related changes in hands. Aims: Assess efficacy and safety of two injection techniques to treat age-related changes in the hands using calcium hydroxylapatite filler, Radiesse®. Settings and Design: This was a prospective, comparative, evaluator-blind, single-center study. Materials and Methods: Radiesse® (0.8 mL/0.2 mL 2% lidocaine) was injected subdermally on Day (D)01, using a needle multipoint technique in one hand (N) and a fan-like cannula technique in the other (C). Assessments were made pre-injection, on D14, Month (M)02, M03 and M05 using the Merz Aesthetics Hand Grading Scale (MAS) and Global Aesthetic Improvement Scale (GAIS). Participants completed questionnaires on satisfaction, pain and adverse events (AEs). Statistical Analysis Used: Data distribution was tested with the Shapiro-Wilk and Levene's tests. The Wilcoxon signed-rank and Chi-square tests were employed to evaluate quantitative and qualitative data, respectively. Results: All 10 participants completed the study, four opted for a M03 touch-up (0.8 mL Radiesse®). Evaluator-assessed mean GAIS scores were between 2 (significant improvement but not complete correction) and 3 (optimal cosmetic result) at each time point. The MAS score improved from D01 to M05 (N: 2.60 to 1.40; C: 2.20 to 1.30). Following treatment, participants reported skin was softer, more elastic, more youthful and less wrinkled. Other than less noticeable veins and tendons on the C hand, no differences in participant satisfaction were noted. All AEs were mild, with no serious AEs reported. Conclusions: Both injection techniques (needle and cannula) demonstrated equivalent clinical efficacy with a comparable safety profile for the correction of age-related changes in hands with Radiesse®. PMID:26644738

  8. Evaluation of an Immunochromatographic Assay Kit for Rapid Identification of Mycobacterium tuberculosis Complex in Clinical Isolates▿

    PubMed Central

    Park, Mi Young; Kim, Young Jin; Hwang, Sang Hyun; Kim, Hyoung Hoi; Lee, Eun Yup; Jeong, Seok Hoon; Chang, Chulhun L.

    2009-01-01

    We evaluated a new immunochromatographic assay (ICA) using mouse monoclonal anti-MPT64 antibody for rapid discrimination between Mycobacterium tuberculosis and nontuberculous mycobacteria in clinical isolates. A study with mycobacteria and other organisms showed excellent sensitivity (≅99%) and specificity (100%) and an appropriate detection limit (105 CFU/ml) when tested with M. tuberculosis H37Rv. This ICA can simplify the identification of M. tuberculosis in clinical laboratories. PMID:19052177

  9. [Financial conflict of interest in clinical psychiatry studies: a review].

    PubMed

    Ulaş, Halis; Binbay, Tolga; Alptekin, Köksal

    2008-01-01

    Pharmaceutical industry revenues from global pharmaceutical sales have increased 7% to $602 billion in 2005. Approximately 15% of these revenues were spent on clinical research and drug development studies. Because of the huge budget allocated to research and development studies the number of studies being conducted by pharmaceutical companies has increased. The impact of the pharmaceutical industry on clinical trials has been affected by financial conflicts of interest between researchers and the industry. Conflict of interest refers to a situation in which it appears that a researcher's personal financial interest could significantly affect the design, conduct, and/or reporting of such research. Financial conflict of interest has been reported to be frequent in clinical trials in general medicine. It is estimated that 89%-98% of comparative drug treatment studies are funded by pharmaceutical companies. It was reported that favorable outcomes for the firms conducting these studies were significantly more common in industry-funded studies than in non-industry funded ones. These biased outcomes were due to conscious or unconscious decisions about the design, data analysis, and publishing of the studies. Biased outcomes of industry-funded studies have diminished the integrity of academic institutions, pharmaceutical companies, researchers, and scientific journals; therefore, various precautions have been taken in order to reduce the effect of conflict of interest on study outcomes. The aim of this review was to evaluate the effect of conflict of interest on outcomes in clinical psychiatry studies. PMID:19110984

  10. 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. PMID:24551353

  11. Design and Evaluation of a Bacterial Clinical Infectious Diseases Ontology

    PubMed Central

    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. PMID:24551353

  12. 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

  13. [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

  14. 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

  15. 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.

  16. 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

  17. 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

    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

    2014-11-01

    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

  18. 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. PMID:27508156

  19. 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

  20. Evaluating clinical decision support rules as an intervention in clinician workflows with technology.

    PubMed

    Brokel, Jane M; Schwichtenberg, Tamara J; Wakefield, Douglas S; Ward, Marcia M; Shaw, Michael G; Kramer, J Michael

    2011-01-01

    The implementation of electronic health records in rural settings generated new challenges beyond those seen in urban hospitals. The preparation, implementation, and sustaining of clinical decision support rules require extensive attention to standards, content design, support resources, expert knowledge, and more. A formative evaluation was used to present progress and evolution of clinical decision support rule implementation and use within clinician workflows for application in an electronic health record. The rural hospital was able to use clinical decision support rules from five urban hospitals within its system to promote safety, prevent errors, establish evidence-based practices, and support communication. This article describes tools to validate initial 54 clinical decision support rules used in a rural referral hospital and 17 used in clinics. Since 2005, the study hospital has added specific system clinical decision support rules for catheter-acquired urinary tract infection, deep venous thrombosis, heart failure, and more. The findings validate the use of clinical decision support rules across sites and ability to use existing indicators to measure outcomes. Rural hospitals can rapidly overcome the barriers to prepare and implement as well as sustain use of clinical decision support rules with a systemized approach and support structures. A model for design and validation of clinical decision support rules into workflow processes is presented. The replication and reuse of clinical decision support rule templates with data specifications that follow data models can support reapplication of the rule intervention in subsequent rural and critical access hospitals through system support resources. PMID:21099543

  1. 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

  2. [Extension bridges. A bibliographic evaluation and the clinical indications].

    PubMed

    Irato, A; Garrone, P; Catapano, S; Carossa, S

    1990-11-01

    Extension bridges are a valid alternative to partial and implanted prostheses for the rehabilitation of small intercalary or distal lacunae. Following a critical review of published reports on the subject and the assessment of longitudinal studies, the authors examine the clinical parameters and technical procedures used to implement these prosthetic reconstructions. PMID:2084528

  3. A Systematic Review of Studies Comparing Diagnostic Clinical Prediction Rules with Clinical Judgment

    PubMed Central

    Sanders, Sharon; Doust, Jenny; Glasziou, Paul

    2015-01-01

    Background Diagnostic clinical prediction rules (CPRs) are developed to improve diagnosis or decrease diagnostic testing. Whether, and in what situations diagnostic CPRs improve upon clinical judgment is unclear. Methods and Findings We searched MEDLINE, Embase and CINAHL, with supplementary citation and reference checking for studies comparing CPRs and clinical judgment against a current objective reference standard. We report 1) the proportion of study participants classified as not having disease who hence may avoid further testing and or treatment and 2) the proportion, among those classified as not having disease, who do (missed diagnoses) by both approaches. 31 studies of 13 medical conditions were included, with 46 comparisons between CPRs and clinical judgment. In 2 comparisons (4%), CPRs reduced the proportion of missed diagnoses, but this was offset by classifying a larger proportion of study participants as having disease (more false positives). In 36 comparisons (78%) the proportion of diagnoses missed by CPRs and clinical judgment was similar, and in 9 of these, the CPRs classified a larger proportion of participants as not having disease (fewer false positives). In 8 comparisons (17%) the proportion of diagnoses missed by the CPRs was greater. This was offset by classifying a smaller proportion of participants as having the disease (fewer false positives) in 2 comparisons. There were no comparisons where the CPR missed a smaller proportion of diagnoses than clinical judgment and classified more participants as not having the disease. The design of the included studies allows evaluation of CPRs when their results are applied independently of clinical judgment. The performance of CPRs, when implemented by clinicians as a support to their judgment may be different. Conclusions In the limited studies to date, CPRs are rarely superior to clinical judgment and there is generally a trade-off between the proportion classified as not having disease and the

  4. Applying the clinical adoption framework to evaluate the impact of an ambulatory electronic medical record.

    PubMed

    Lau, Francis; Partridge, Colin; Randhawa, Gurprit; Bowen, Mike

    2013-01-01

    This paper describes the application of the Clinical Adoption (CA) Framework to evaluate the impact of a recently deployed electronic medical record (EMR) in a Canadian healthcare organization. The CA Framework dimensions evaluated were EMR quality, use and net benefits at the micro level; and people, organization and implementation at the meso level. The study involved clinical and support staff from two ambulatory care clinics, and managers and technical staff from the organization. A number of issues were identified at both levels of the CA Framework that had affected EMR adoption in the two clinics. Some perceived benefits in care coordination and efficiency were reported despite challenges that arose from early deployment decisions. There were five lessons that could be applied to other ambulatory care settings. The CA Framework has proved useful in making sense of ways that EMR can add value to the organization. PMID:23388247

  5. 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

  6. [Practical assessment. Clinical evaluation of normal-tension glaucoma].

    PubMed

    Valtot, F

    2005-06-01

    Normal-tension glaucoma is a form of primary open-angle glaucoma where the intraocular pressure remains within the normal range. The progression of the disease is usually very slow. The main challenge is to establish the correct diagnosis, with a double risk: the patient might have undetected (and untreated) high intraocular pressure or, the patient might have a nonglaucomatous (possibly treatable) disease looking as a glaucomatous optic neuropathy. The clinical evaluation of the patient suspected of a normal-tension glaucoma must answer two questions: 1) is the intraocular pressure normal?, 2) is it a glaucomatous optic neuropathy or another type of optic neuropathy? PMID:16208237

  7. 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

  8. 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. PMID:25265265

  9. 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

  10. Evaluation of the Mayo Clinic Phenotype-Based Genotype Predictor Score in Patients with Clinically Diagnosed Hypertrophic Cardiomyopathy

    PubMed Central

    Murphy, Sinead L.; Anderson, Jason H.; Kapplinger, Jamie D.; Kruisselbrink, Teresa M.; Gersh, Bernard J.; Ommen, Steve R.; Ackerman, Michael J.; Bos, J. Martijn

    2016-01-01

    Genetic testing for hypertrophic cardiomyopathy (HCM) can provide an important clinical marker for disease outcome and family screening. This study set out to validate our recently developed phenotype-based HCM genotype predictor score. Patients clinically diagnosed with HCM and evaluated by genetic counselors comprised the study cohort. Genotype score was derived based on clinical and echocardio-graphic variables. Total score was correlated with the yield of genetic testing. Of 564 HCM patients, 198 sought genetic testing (35 %; 55 % male; mean age at diagnosis, 50 ±20 years). Of these, 101 patients (51 %) were genotype positive for a HCM-associated genetic mutation (55 % male; mean age at diagnosis, 42 ± 18 years). Cochran-Armitage analysis showed similar, statistically significant trends of increased yields for higher genotype scores for both the original and study cohort. Validated by the current study, this scoring system provides an easy-to-use, clinical tool to aid in determining the likelihood of a positive HCM genetic test. PMID:26914223

  11. The Effects of Aging on Clinical Vestibular Evaluations

    PubMed Central

    Maheu, Maxime; Houde, Marie-Soleil; Landry, Simon P.; Champoux, François

    2015-01-01

    Balance disorders are common issues for aging populations due to the effects of normal aging on peripheral vestibular structures. These changes affect the results of vestibular function evaluations and make the interpretation of these results more difficult. The objective of this article is to review the current state of knowledge of clinically relevant vestibular measures. We will first focus on otolith function assessment methods cervical-VEMP (cVEMP) and ocular-VEMP (oVEMP), then the caloric and video-head impulse test (vHIT) methods for semicircular canals assessment. cVEMP and oVEMP are useful methods, though research on the effects of age for some parameters are still inconclusive. vHIT results are largely independent of age as compared to caloric stimulation and should therefore be preferred for the evaluation of the semicircular canals function. PMID:26441824

  12. Evaluation of NOC standardized outcome of "health seeking behavior" in nurse-managed clinics.

    PubMed

    Macnee, Carol L; Edwards, Joellen; Kaplan, Amy; Reed, Sue; Bradford, Susanne; Walls, Jennie; Schaller-Ayers, Jennifer M

    2006-01-01

    This study evaluated the accomplishment of the Nursing Outcomes Classification (NOC) outcome "Health Seeking Behavior" in 5 nurse-managed clinics. Nurse practitioners and registered nurses rated patients on 11 indicators of health seeking behaviors, and recorded their level of knowledge of the patient. A total of 556 evaluations were collected. Health seeking behavior scores were lowest in a rural county school-based clinic and highest in a federally qualified health center. Ratings increased with nurses' knowledge of patients and for older patients. PMID:16816605

  13. Study design and methods of the BoTULS trial: a randomised controlled trial to evaluate the clinical effect and cost effectiveness of treating upper limb spasticity due to stroke with botulinum toxin type A

    PubMed Central

    Rodgers, Helen; Shaw, Lisa; Price, Christopher; van Wijck, Frederike; Barnes, Michael; Graham, Laura; Ford, Gary; Shackley, Phil; Steen, Nick

    2008-01-01

    Background Following a stroke, 55–75% of patients experience upper limb problems in the longer term. Upper limb spasticity may cause pain, deformity and reduced function, affecting mood and independence. Botulinum toxin is used increasingly to treat focal spasticity, but its impact on upper limb function after stroke is unclear. The aim of this study is to evaluate the clinical and cost effectiveness of botulinum toxin type A plus an upper limb therapy programme in the treatment of post stroke upper limb spasticity. Methods Trial design : A multi-centre open label parallel group randomised controlled trial and economic evaluation. Participants : Adults with upper limb spasticity at the shoulder, elbow, wrist or hand and reduced upper limb function due to stroke more than 1 month previously. Interventions : Botulinum toxin type A plus upper limb therapy (intervention group) or upper limb therapy alone (control group). Outcomes : Outcome assessments are undertaken at 1, 3 and 12 months. The primary outcome is upper limb function one month after study entry measured by the Action Research Arm Test (ARAT). Secondary outcomes include: spasticity (Modified Ashworth Scale); grip strength; dexterity (Nine Hole Peg Test); disability (Barthel Activities of Daily Living Index); quality of life (Stroke Impact Scale, Euroqol EQ-5D) and attainment of patient-selected goals (Canadian Occupational Performance Measure). Health and social services resource use, adverse events, use of other antispasticity treatments and patient views on the treatment will be compared. Participants are clinically reassessed at 3, 6 and 9 months to determine the need for repeat botulinum toxin type A and/or therapy. Randomisation : A web based central independent randomisation service. Blinding : Outcome assessments are undertaken by an assessor who is blinded to the randomisation group. Sample size : 332 participants provide 80% power to detect a 15% difference in treatment successes between

  14. 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. PMID:24600653

  15. Prostaglandins: a report on early clinical studies

    PubMed Central

    Hinman, J. W.

    1970-01-01

    The prostaglandins are a unique group of pharmacologically active lipids which are widely distributed in mammalian tissues and body fluids. The chemistry of this family of compounds has been established in elegant detail. Research quantities of these highly active natural compounds were obtained by enzymatic bioconversion of essential fatty acids and now studies devoted to the elucidation of their physiological roles and their clinical potential are progressing rapidly. Fields of greatest current interest in clinical medicine include renal-cardiovascular research, induction of labour and therapeutic abortion, control of the reproductive cycle (including fertility control), bronchodilation, enhancement of nasal patency and antisecretory activity. Results available to date are too preliminary for many conclusions to be drawn, but are sufficiently encouraging to assure continued and expanding efforts in several fields. PMID:4098885

  16. Is it the time to rethink clinical decision-making strategies? From a single clinical outcome evaluation to a Clinical Multi-criteria Decision Assessment (CMDA).

    PubMed

    Migliore, Alberto; Integlia, Davide; Bizzi, Emanuele; Piaggio, Tomaso

    2015-10-01

    There are plenty of different clinical, organizational and economic parameters to consider in order having a complete assessment of the total impact of a pharmaceutical treatment. In the attempt to follow, a holistic approach aimed to provide an evaluation embracing all clinical parameters in order to choose the best treatments, it is necessary to compare and weight multiple criteria. Therefore, a change is required: we need to move from a decision-making context based on the assessment of one single criteria towards a transparent and systematic framework enabling decision makers to assess all relevant parameters simultaneously in order to choose the best treatment to use. In order to apply the MCDA methodology to clinical decision making the best pharmaceutical treatment (or medical devices) to use to treat a specific pathology, we suggest a specific application of the Multiple Criteria Decision Analysis for the purpose, like a Clinical Multi-criteria Decision Assessment CMDA. In CMDA, results from both meta-analysis and observational studies are used by a clinical consensus after attributing weights to specific domains and related parameters. The decision will result from a related comparison of all consequences (i.e., efficacy, safety, adherence, administration route) existing behind the choice to use a specific pharmacological treatment. The match will yield a score (in absolute value) that link each parameter with a specific intervention, and then a final score for each treatment. The higher is the final score; the most appropriate is the intervention to treat disease considering all criteria (domain an parameters). The results will allow the physician to evaluate the best clinical treatment for his patients considering at the same time all relevant criteria such as clinical effectiveness for all parameters and administration route. The use of CMDA model will yield a clear and complete indication of the best pharmaceutical treatment to use for patients

  17. 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

  18. Functional outcomes for clinical evaluation of implant restorations.

    PubMed

    Bassi, Francesco; Carr, Alan B; Chang, Ting-Ling; Estafanous, Emad W; Garrett, Neal R; Happonen, Risto-Pekka; Koka, Sreenivas; Laine, Juhani; Osswald, Martin; Reintsema, Harry; Rieger, Jana; Roumanas, Eleni; Salinas, Thomas J; Stanford, Clark M; Wolfaardt, Johan

    2013-01-01

    The functional outcomes related to treating patients afflicted with tooth loss are an important hallmark in substantiating prosthodontic intervention. The Oral Rehabilitation Outcomes Network (ORONet) conducted two international workshops to develop a core set of outcome measures, including a functional domain. The process followed the general format used in the Outcome Measures in Rheumatology (OMERACT) workshops to develop consensus for clinical outcome measures in arthritis research, which included: developing a comprehensive list of potential outcomes in the literature; submitting them to a filter for validity, clinical discrimination, and feasibility; and ranking those measures meeting all the filter criteria for relative value. The search was conducted to include functional assessments of speech, swallowing, mastication, nutrition, sensation, and motor function as they relate to dental implant therapies. This literature review surveyed 173 papers that produced some result of these descriptors in the functional domain. Of these, 67 papers reported on functional assessments and further defined objective and subjective outcomes. Many of these results were patient-perceived improvements in function, while others were objective assessments based on established methodologies and instruments. Objective evaluations of masticatory function and speech may meet criteria for validity and discriminability for selected interventions, but are generally not feasible for routine use in clinical care settings. The current recommendation is to employ a well-validated survey instrument that covers mastication and speech, such as the Oral Health Impact Profile (OHIP-14, short form), recognizing that patient perceptions of function may differ from objective ability. PMID:23998137

  19. [Comparative analysis of 2 clinical scales for clinical evaluation in multiple sclerosis: review of 302 cases].

    PubMed

    Felipe, E; Mendes, M F; Moreira, M A; Tilbery, C P

    2000-06-01

    Many neurologic scales have been used for clinical evaluation of multiple sclerosis, but there is no consensus about which one is the most appropriate to assess evolution and point to a new relapse. The Expanded Disability Status Scale (EDSS) has been the most commonly used. We analyse the reliability of two scales: the EDSS and Neurologic Rating Scale (NRS) in 302 multiple sclerosis patients. It is shown that NRS is a more sensitive scale than EDSS to disclose clinical changes (22.1% of cases). Changes in NRS were more evident in patients with EDSS 3.0 and 3.5. We comment on these findings and suggest that both scales should be employed in multiple sclerosis treatment trials. PMID:10849631

  20. Experimental and clinical evaluation of a prototype hyperthermia system.

    PubMed

    Uozumi, H; Baba, Y; Yasunaga, T; Takahashi, M

    1987-01-01

    In order to achieve better thermal distribution, a high output radiofrequency capacitive heating system was developed for hyperthermia and operated at a frequency of 13.56 MHz with an output of 1,000 watts (Inter Nova Inc., IH-1000). With use of this equipment, an agar phantom study, an animal experiment, and a clinical trial have been performed. This unit has made it possible to use large applicators with large electrodes. The phantom study revealed homogeneous, deep-heating capability. In the animal study using a miniature pig, good thermal distribution within the body was obtained, but the problem of overheating the subcutaneous fat layer remained. In the clinical application, some limiting factors remained unsolved in spite of our attempts to eliminate them; however, the problem of insufficient power supply was solved. PMID:3321198

  1. Ongoing evaluation of PACS in a clinical setting

    NASA Astrophysics Data System (ADS)

    Trefler, Martin; Russell, Edward

    1992-05-01

    The radiology department of Jackson Memorial Hospital processes 255,000 clinical examinations each year -- 65,000 of which are portable x rays. Film transportation and loss are major obstacles to the smooth operation of this department. To assist in the solution of these problems we have designed and begun the piecemeal installation of a clinical PACS. This system is based on a platform of IBM RISC/6000 computers and software developed by Genesys Corporation. The initial installation involved the digitization of the portable x rays from three ICUs. The images (in the form of a matrix of 2048 X 1648 pixels) are then entered into the network and can be viewed simultaneously in the radiology department and in the ICU. The second phase of installation, involving the images from two CT scanners and two MRI scanners is currently underway. We have evaluated the system from several standpoints. The first is user acceptance. The users are the radiologists who must make the diagnosis at the workstation and the referring physicians who need the diagnosis quickly but also require the image. The radiologists must be comfortable with their diagnosis based on the images presented at the two viewer workstation. This is compared to the use of a multiviewer which presents many radiographs simultaneously. The second parameter for evaluation involves the impact on patient care in terms of the time elapsed between the taking of the radiograph and the presentation to the physician of the image and the diagnosis.

  2. Shortcomings in the Evaluation of Students' Clinical Skills and Behaviors in Medical School.

    ERIC Educational Resources Information Center

    Kassebaum, Donald G.; Eaglen, Robert H.

    1999-01-01

    A study examined the extent to which current medical-student evaluation assesses noncognitive clinical skills and behaviors needed by graduates, including small-group conferences, case-based discussion, library research, lifelong learning, reasoned thinking, interpersonal skills, and logical/sequenced history taking and physical examinations.…

  3. 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. PMID:27251355

  4. Clinical studies with tumour necrosis factor.

    PubMed

    Spriggs, D R; Sherman, M L; Frei, E; Kufe, D W

    1987-01-01

    The mechanism of tumour necrosis factor (TNF) cytotoxicity remains unknown. The in vivo antitumour effects of TNF may be related to direct cytotoxicity, immunomodulatory effects or endothelial effects on tumour vasculature. Phase I and early Phase II clinical trials of human recombinant TNF are under way in Japan, the USA, the UK and Germany. The maximum Phase II dose for TNF has not been established. The clinical toxicity of TNF is generally similar to that of other biological agents. Systemic toxicity, including fever, chills, anorexia and nausea, has been seen in most patients treated with TNF and has not been clearly related to dose. Other toxicities have included liver function abnormalities, hypotension, transient neurological changes and haematological abnormalities. Few clinical responses have been reported but organized Phase II testing remains to be completed. Combination trials with interferons have recently been initiated. Phase II efficacy studies of TNF as a single agent and in combination are needed for an assessment of the value of this agent in cancer therapy. PMID:3330011

  5. Clinical studies in lysosomal storage diseases

    PubMed Central

    Boudes, Pol F

    2013-01-01

    Lysosomal storage disorders (LSDs) consist of over 40 diseases, some of which are amenable to treatment. In this review, we consider the regulatory context in which LSDs studies are performed, highlight design specificities and explore operational challenges. Orphan drug legislations, both in Europe and US, were effective to stimulate LSDs drug development. However, regulators flexibilities toward approval vary leading to global discrepancies in access to treatments. Study designs are constrained because few patients can be studied. This implies LSDs treatments need to demonstrate large levels of clinical efficacy. If not, an appropriate level of evidence is difficult to achieve. While biomarkers could address this issue, none have been truly accepted as primary outcome. Enrichment of study population can increase the chance of success, especially with clinical outcomes. Adaptive designs are operationally challenging. Innovative methods of analysis can be used, notably using a patient as his/her own control and responder analysis. The use of extension phases and patient registries as a source of historical comparison can facilitate data interpretation. Operationally, few patients are available per centers and multiple centers need to be initiated in multiple countries. This impacts time-lines and budget. In the future, regulators flexibility will be essential to provide patients access to innovative treatments. PMID:25003011

  6. [Agreement between Clinical Evaluation and Structured Clinical Interviews in Psychosomatic Inpatients].

    PubMed

    Reichert, Cornelia; Henniger, Stephan; Jäger, Burkard; de Zwaan, Martina

    2015-05-01

    The goal of this study was to determine the agreement between axis I mental disorders assessed with a structured clinical interview (SCID) and independently obtained non-structured clinical diagnoses in 185 psychosomatic in-patients. Additionally, the study focuses on the detection of potential predictors for the level of agreement. Diagnostic agreement was poor to moderate for the mood, anxiety and somatoform disorder cluster (κ = 0.293-0.444). Only for eating disorders an almost complete concordance could be found (κ = 0.812). The predictor analysis indicated a significant positive association between the comorbidity rate and the agreement in mood disorders. Furthermore, the diagnostic agreement of anxiety disorders was significantly higher for female than for male patients. These results reveal that even a team-based clinical diagnosis, assessed over the period of a hospital stay, shows little agreement with SCID-diagnoses. The predictor analysis as well as the poor correlation in 3 of 4 diagnostic clusters suggest that conceptual differences of the disorder criteria as well as their clinical interpretation might influence the concordance between diagnoses. Further studies focusing on methodical factors might reveal further insights to the cause of the diagnostic discrepancies. PMID:25941987

  7. 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

  8. 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

  9. Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial

    PubMed Central

    Amrutesh, Sunita; Malini, J; Tandur, Prakash S; Patki, Pralhad S

    2010-01-01

    Background The aim of this study was to evaluate the efficacy and safety of herbal dental cream in comparison to fluoride dental cream. Objectives Clinical evaluation of a novel herbal dental cream in plaque formation: a double-blind, randomized, controlled clinical trial. Methods One hundred and two patients with established dental plaque were randomly assigned to either herbal dental group or fluoride dental group for six weeks in a double-blind design. Improvement in plaque index, oral hygiene status, bleeding index, and gingival index was evaluated in these patients along with microbiological study. Results Results indicated a significant reduction in plaque index, gingival index, oral hygiene index, and microbial growth in both groups. Difference between the groups was not significant. There was no significant change in bleeding index. No adverse events were reported and both the dental creams were well tolerated. Conclusion The finding of this preliminary study indicates that herbal dental cream is as safe and effective as fluoride dental cream, but not superior to it. PMID:27186096

  10. 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…

  11. 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. PMID:25784501

  12. Doxofylline and Theophylline: A Comparative Clinical Study

    PubMed Central

    Akram, MD Faiz; Nasiruddin, Mohammad; Ahmad, Zuber; Ali Khan, Rahat

    2012-01-01

    Objectives COPD is one of the major public health problems worldwide. Theophylline has been used in the treatment of COPD for decades. Doxofylline a new theophylline congener has been claimed to have better safety profile. The study was undertaken to compare theophylline and doxophylline at doses recommended and commonly used in clinical practice. Methods The study was conducted in patients of COPD in TB chest department of a medical college hospital. It was randomized, prospective and open label. A total of 154 patients were divided in two group .Group I was administered 400 mg theophylline SR once daily and group II was administered doxofylline 400 mg twice a day orally. Spirometric variables symptom score, and adverse effects were recorded on day 0, 7 and 21 of therapy. Data were compared and analysed using SPSS version 16. Results Results of the study showed that there was no statistically significant difference with respect to spirometric variables and symptom score in the two groups and there was no significant difference in two groups with respect to side effects (p>0.05). Conclusions It is concluded that doxophylline has no advantage over theophylline in terms of either efficacy or safety on the doses commonly used in current clinical practice. PMID:23373027

  13. Clinical laboratory studies in Barth Syndrome.

    PubMed

    Vernon, Hilary J; Sandlers, Yana; McClellan, Rebecca; Kelley, Richard I

    2014-06-01

    Barth Syndrome is a rare X-linked disorder characterized principally by dilated cardiomyopathy, skeletal myopathy and neutropenia and caused by defects in tafazzin, an enzyme responsible for modifying the acyl chain moieties of cardiolipin. While several comprehensive clinical studies of Barth Syndrome have been published detailing cardiac and hematologic features, descriptions of its biochemical characteristics are limited. To gain a better understanding of the clinical biochemistry of this rare disease, we measured hematologic and biochemical values in a cohort of Barth Syndrome patients. We characterized multiple biochemical parameters, including plasma amino acids, plasma 3-methylglutaconic acid, cholesterol, cholesterol synthetic intermediates, and red blood cell membrane fatty acid profiles in 28 individuals with Barth Syndrome from ages 10 months to 30 years. We describe a unique biochemical profile for these patients, including decreased plasma arginine levels. We further studied the plasma amino acid profiles, cholesterol, cholesterol synthetic intermediates, and plasma 3-methylglutaconic acid levels in 8 female carriers and showed that they do not share any of the distinct, Barth Syndrome-specific biochemical laboratory abnormalities. Our studies augment and expand the biochemical profiles of individuals with Barth Syndrome, describe a unique biochemical profile for these patients, and provide insight into the possible underlying biochemical pathology in this disorder. PMID:24751896

  14. [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. PMID:16130685

  15. A systematic review, evidence synthesis and meta-analysis of quantitative and qualitative studies evaluating the clinical effectiveness, the cost-effectiveness, safety and acceptability of interventions to prevent postnatal depression.

    PubMed Central

    Morrell, C Jane; Sutcliffe, Paul; Booth, Andrew; Stevens, John; Scope, Alison; Stevenson, Matt; Harvey, Rebecca; Bessey, Alice; Cantrell, Anna; Dennis, Cindy-Lee; Ren, Shijie; Ragonesi, Margherita; Barkham, Michael; Churchill, Dick; Henshaw, Carol; Newstead, Jo; Slade, Pauline; Spiby, Helen; Stewart-Brown, Sarah

    2016-01-01

    BACKGROUND Postnatal depression (PND) is a major depressive disorder in the year following childbirth, which impacts on women, their infants and their families. A range of interventions has been developed to prevent PND. OBJECTIVES To (1) evaluate the clinical effectiveness, cost-effectiveness, acceptability and safety of antenatal and postnatal interventions for pregnant and postnatal women to prevent PND; (2) apply rigorous methods of systematic reviewing of quantitative and qualitative studies, evidence synthesis and decision-analytic modelling to evaluate the preventive impact on women, their infants and their families; and (3) estimate cost-effectiveness. DATA SOURCES We searched MEDLINE, EMBASE, Science Citation Index and other databases (from inception to July 2013) in December 2012, and we were updated by electronic alerts until July 2013. REVIEW METHODS Two reviewers independently screened titles and abstracts with consensus agreement. We undertook quality assessment. All universal, selective and indicated preventive interventions for pregnant women and women in the first 6 postnatal weeks were included. All outcomes were included, focusing on the Edinburgh Postnatal Depression Scale (EPDS), diagnostic instruments and infant outcomes. The quantitative evidence was synthesised using network meta-analyses (NMAs). A mathematical model was constructed to explore the cost-effectiveness of interventions contained within the NMA for EPDS values. RESULTS From 3072 records identified, 122 papers (86 trials) were included in the quantitative review. From 2152 records, 56 papers (44 studies) were included in the qualitative review. The results were inconclusive. The most beneficial interventions appeared to be midwifery redesigned postnatal care [as shown by the mean 12-month EPDS score difference of -1.43 (95% credible interval -4.00 to 1.36)], person-centred approach (PCA)-based and cognitive-behavioural therapy (CBT)-based intervention (universal), interpersonal

  16. 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

  17. Evaluating Quality in Clinical Cancer Research: The M.D. Anderson Cancer Center Experience

    PubMed Central

    Cox, James D.; Giralt, Sergio A.; Veazie, Mary L.; Ajani, Jaffer A.; Bruner, Janet M.; Chan, Ka Wah; Hittelman, Walter N.; Hunt, Kelly K.; Iyer, Revathy B.; Karp, Daniel D.; Kuban, Deborah A.; Lippman, Scott M.; Raad, Issam I.; Rodriguez-Bigas, Miguel A.; Zwelling, Leonard A.; Markman, Maurie

    2009-01-01

    Background Despite the unquestionable importance of clinically oriented research designed to test the safety and efficacy of new therapies in patients with malignant disease, there is limited information regarding strategies to evaluate the quality of such efforts at academic institutions. Methods To address this issue, a committee of senior faculty at the University of Texas M.D. Anderson Cancer Center established specific criteria by which investigators from all departments engaged in clinical research could be formally evaluated. Scoring criteria were established and revised based on the results of a pilot study. Beginning in January 2004, the committee evaluated all faculty involved in clinical research within 35 departments. Scores for individual faculty members were assigned on a scale of 1 (outstanding) to 5; a score of 3 was set as the standard for the institution. Each department also received a score. The results of the evaluation were shared with departmental chairs and the Chief Academic Officer. Results 392 faculty were evaluated. The median score was 3. Full professors more frequently received a score of 1, but all faculty ranks received scores of 4 and 5. As a group, tenure/tenure track faculty achieved superior scores compared to nontenure track faculty. Conclusions Based on our experience, we believe it is possible to conduct a rigorous consensus-based evaluation of the quality of clinical cancer research being conducted at an academic medical center. It is reasonable to suggest such evaluations can be used as a management tool and may lead to higher-quality clinical research. PMID:19571599

  18. Clinical studies of neuroinflammatory mechanisms in schizophrenia.

    PubMed

    Watkins, Crystal C; Andrews, Sarah Ramsay

    2016-09-01

    Schizophrenia is a pervasive neurodevelopmental disorder that appears to result from genetic and environmental factors. Although the dopamine hypothesis is the driving theory behind the majority of translation research in schizophrenia, emerging evidence suggests that aberrant immune mechanisms in the peripheral and central nervous system influence the etiology of schizophrenia and the pathophysiology of psychotic symptoms that define the illness. The initial interest in inflammatory processes comes from epidemiological data and historical observations, dating back several decades. A growing body of research on developmental exposure to infection, stress-induced inflammatory response, glial cell signaling, structural and functional brain changes and therapeutic trials demonstrates the impact that inflammation has on the onset and progression of schizophrenia. Research in animal models of psychosis has helped to advance clinical and basic science investigations of the immune mechanisms disrupted in schizophrenia. However, they are limited by the inability to recapitulate the human experience of hallucinations, delusions and thought disorder that define psychosis. To date, translational studies of inflammatory mechanisms in human subjects have not been reviewed in great detail. Here, we critically review clinical studies that focus on inflammatory mechanisms in schizophrenia. Understanding the neuroinflammatory mechanisms involved in schizophrenia may be essential in identifying potential therapeutic targets to minimize the morbidity and mortality of schizophrenia by interrupting disease development. PMID:26235751

  19. 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

  20. 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.

  1. Evaluation of Clinical Use of Indigenously Developed Delta Plate in Management of Subcondylar Fracture

    PubMed Central

    Anirudhan, Anroop; Khalam, Sherin A.; Zachariah, Rakesh Koshy

    2013-01-01

    Condylar fractures account for 25-35% of mandibular fractures and deserve a special consideration apart from rest of the mandible due to their anatomical differences and healing potential. Previous clinical and biomechanical studies have recommended using two miniplates for fixation of condyle fractures. Two miniplates require a certain size of the proximal condyle fragment and thus are applicable mainly in cases involving low fractures. The present study evaluates the clinical use of indigenously developed titanium delta-shaped miniplate in open reduction and internal fixation of subcondylar fracture. PMID:24765516

  2. Evaluation of clinical use of indigenously developed delta plate in management of subcondylar fracture.

    PubMed

    Anirudhan, Anroop; Khalam, Sherin A; Zachariah, Rakesh Koshy

    2013-08-01

    Condylar fractures account for 25-35% of mandibular fractures and deserve a special consideration apart from rest of the mandible due to their anatomical differences and healing potential. Previous clinical and biomechanical studies have recommended using two miniplates for fixation of condyle fractures. Two miniplates require a certain size of the proximal condyle fragment and thus are applicable mainly in cases involving low fractures. The present study evaluates the clinical use of indigenously developed titanium delta-shaped miniplate in open reduction and internal fixation of subcondylar fracture. PMID:24765516

  3. Evaluating Business Value of IT in Healthcare: Three Clinical Practices from Australia and the US.

    PubMed

    Haddad, Peter; Schaffer, Jonathan L; Wickramasinghe, Nilmini

    2015-01-01

    Exponentially increasing costs in healthcare coupled with poor quality and limited access have motivated the healthcare industry to turn to IS/IT solutions to overcome these issues and facilitate superior healthcare delivery. In an environment of rapid development of new clinical informatics solutions claiming to provide better healthcare delivery, there is a paucity of systematic frameworks to robustly measure the actual value of these systems. The promised business value of these solutions has been elusive; hence, this study offers an approach for the evaluation of the business value of health IS/IT solutions based on a conceptual model, which has been validated using three clinical case studies. PMID:26262035

  4. 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

  5. Case studies in clinical practice development.

    PubMed

    Chopra, Romi; Lipman, John; Murphy, Timothy P

    2005-03-01

    By asking identical questions of several successful practitioners of clinical interventional radiology, a snapshot of the current and future status of interventional radiology as a clinical discipline is presented. PMID:21326672

  6. 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. PMID:14872068

  7. [Cardiac myxoma in the elderly. Clinical study].

    PubMed

    Pentimone, F; Del Corso, L; Siuti, E; Verunelli, F; Bortolotti, U; Salvatore, L

    1997-01-01

    Cardiac mixoma in the elderly. A clinical study. The clinical features of 13 cardiac myxomas surgically resected are presented. The mean age at presentation was 68 years. Ten were in the left atrium, 5 near the fossa ovalis, 3 at the base of the atrial septum, 1 at the inferior wall and 1 on the anterior leaflet of mitral valve, 3 were in the right atrium, 1 of these was accompanied with a myxoma at the apex of left ventricle. The ECG and the chest X-ray were normal in 9 and in 8 patients, respectively. In 3 patients, the diagnosis was occasionally made by routine 2-dimensional echocardiography. 5 patients presented with fever of unknown origin, arthralgias, weakness, weight loss. None had intracardiac or extracardiac recurrence in the 73 months follow-up. The presentation with constitutional symptoms only like fever of UO, may mimic collagen and neoplastic diseases, vasculitis, lymphomas: the 2-dimensional echocardiography is mandatory to esclude a cardiac myxoma in the elderly. PMID:9213810

  8. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem. PMID:24165457

  9. Clinical studies of intestinal folate conjugases.

    PubMed

    Halsted, C H; Beer, W H; Chandler, C J; Ross, K; Wolfe, B M; Bailey, L; Cerda, J J

    1986-03-01

    Clinical differences between the two human intestinal mucosal folate conjugases were assessed by measurement of their activities in normal individuals and in patients with chronic diarrhea of differing causes. Intracellular folate conjugase (ICFC) was 15-fold more active than brush border folate conjugase (BBFC) in jejunal mucosa from seven obese patients undergoing elective gastric bypass surgery. The activity of ICFC was similar among normal volunteers and patients with diarrhea of unknown origin (DUO), gluten-sensitive enteropathy (GSE), inflammatory bowel disease (IBD), and the short bowel syndrome (IBD-SBS). By contrast, BBFC, sucrase, and lactase were decreased significantly in GSE, and BBFC was increased in IBD-SBS. The activity of BBFC correlated with lactase and with sucrase in the normal subjects and in patients with DUO, whereas no correlations were found with the activity of ICFC in any group. Our clinical studies confirm that ICFC and BBFC are different enzymes. ICFC is not affected by intestinal disease, whereas the activity of jejunal BBFC, like that of other brush border enzymes, is decreased by mucosal injury and is also capable of adapting to distal small intestinal disease or surgical resection. PMID:3081671

  10. 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

  11. 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. PMID:26767715

  12. Dissociated vertical deviation-a clinical and laboratory study.

    PubMed Central

    Helveston, E M

    1980-01-01

    The previously reported nomenclature and clinical characteristics of dissociated vertical deviation have been recorded. The incidence and characteristics of DVD have been determined by evaluation of 1,000 consecutive strabismus or nystagmus patients, and with selected chart study carried out on the 111 DVD patients found in this series. Electro-oculographic studies of selected patients with DVD provided objective evidence of the speed and amplitude of the ocular movements in DVD. Bell phenomenon, strabismus sursoadductorius and the Bielschowsky phenomenon were recorded and compared to clinical findings of strabismus patients with DVD. The technique for the results of surgery for DVD were described. Dissociated vertical deviation was characterized as a component of the overall strabismus picture. Images FIGURE 1 A FIGURE 1 B FIGURE 1 C FIGURE 1 D FIGURE 1 E FIGURE 2 A FIGURE 2 B FIGURE 2 C FIGURE 3 A FIGURE 3 B FIGURE 3 C FIGURE 4 A FIGURE 4 B PMID:7020216

  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. The Alpha Stem Cell Clinic: a model for evaluating and delivering stem cell-based therapies.

    PubMed

    Trounson, Alan; DeWitt, Natalie D; Feigal, Ellen G

    2012-01-01

    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

  15. 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

  16. SPECT-PET in Epilepsy and Clinical Approach in Evaluation.

    PubMed

    Ergün, Eser Lay; Saygi, Serap; Yalnizoglu, Dilek; Oguz, Kader Karli; Erbas, Belkis

    2016-07-01

    In epilepsy, a detailed history, blood chemistry, routine electroencephalography, and brain MRI are important for the diagnosis of seizure type or epilepsy syndrome for the decision of appropriate drug treatment. Although antiepileptic drugs are mostly successful for controlling epileptic seizures, 20%-30% patients are resistant to medical treatment and continue to have seizures. In this intractable patient group, surgical resection is the primarily preferred treatment option. This particular group of patients should be referred to the epilepsy center for detailed investigation and further treatment. When the results of electroencephalography, MRI, and clinical status are discordant or there is no structural lesion on MRI, ictal-periictal SPECT, and interictal PET play key roles for lateralization or localization of epileptic region and guidance for the subsequent subdural electrode placement in intractable epilepsy. SPECT and PET show the functional status of the brain. SPECT and PET play important roles in the evaluation of epilepsy sydromes in childhood by showing abnormal brain regions. Most of the experience has been gained with (18)FDG-PET, in this respect. (11)C-flumazenil-PET usually deliniates the seizure focus more smaller than (18)FDG-PET and is sensitive in identifying medial temporal sclerosis. (11)C-alpha-methyl-l-tryptophan is helpful in the differentiation of epileptogenic and nonepileptogenic regions in children especially in tuberous sclerosis and multifocal cortical dysplasia for the evaluation of surgery. Finally, when there is concordance among these detailed investigations, resective surgery or palliative procedures can be discussed individually. PMID:27237440

  17. 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. PMID:25900144

  18. Evaluation of the clinical chemistry analyser Olympus AU400.

    PubMed

    Lasnier, E; Mario, N; Boque, M C; You, S N; Vaubourdolle, M

    2000-10-01

    The Olympus AU400 analyser (Olympus, Tokyo, Japan) is an automated chemistry instrument for turbidimetric, spectrophotometric and ion selective electrode measurements. Overall analytical performances of the AU400 and the reagents provided by Olympus were evaluated according to the French Society of Clinical Biology guidelines. Twenty parameters including specific proteins, substrates, enzyme activities and electrolytes were tested. The linearity exceeded the specifications given by the manufacturer. Within- and between-run imprecision (CV%), evaluated at two levels, was below 1.5% for ion selective electrode parameters and 3% for other analytes, except for CO2, alkaline phosphatase at low levels and magnesium. Results compared well with those obtained with the analysers routinely used in our laboratory (Behring BNII, Olympus AU800 and Beckman CX3 Delta). The usual positive interferences from lipaemia and haemoglobin on total protein measurement were observed. Creatine kinase and alkaline phosphatase assays were the subject of positive and negative interference by haemoglobin, respectively. There was a negative interference by bilirubin in the uric acid, aspartate-amino transferase, creatine kinase and lactate dehydrogenase assays and a positive interference in the calcium assay. The system was found to be very easy to use and the workstation is user-friendly. PMID:11140621

  19. 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

  20. Development and Psychometric Evaluation of the Nursing Instructors’ Clinical Teaching Performance Inventory

    PubMed Central

    Farahani, Mansoureh A.; Ghasemi, Hormat Sadat Emamzadeh; Nikpeyma, Nasrin; Fereidouni, Zhila; Rassouli, Maryam

    2015-01-01

    Evaluation of nursing instructors’ clinical teaching performance is a prerequisite to the quality assurance of nursing education. One of the most common procedures for this purpose is using student evaluations. This study was to develop and evaluate the psychometric properties of Nursing Instructors’ Clinical Teaching Performance Inventory (NICTPI). The primary items of the inventory were generated by reviewing the published literature and the existing questionnaires as well as consulting with the members of the Faculties Evaluation Committee of the study setting. Psychometric properties were assessed by calculating its content validity ratio and index, and test-retest correlation coefficient as well as conducting an exploratory factor analysis and an internal consistency assessment. The content validity ratios and indices of the items were respectively higher than 0.85 and 0.79. The final version of the inventory consisted of 25 items, and in the exploratory factor analysis, items were loaded on three factors which jointly accounting for 72.85% of the total variance. The test-retest correlation coefficient and the Cronbach’s alpha of the inventory were 0.93 and 0.973, respectively. The results revealed that the developed inventory is an appropriate, valid, and reliable instrument for evaluating nursing instructors’ clinical teaching performance. PMID:25948430

  1. Stroke and Pregnancy: Clinical Presentation, Evaluation, Treatment and Epidemiology

    PubMed Central

    Grear, Karrie E; Bushnell, Cheryl D

    2013-01-01

    Stroke is a neurological emergency that carries a risk of morbidity and mortality. Recent studies have shown that the incidence of stroke, while rare, is increasing in pregnant females. In this review, stroke and other vasculopathies in the pregnant and post-partum female are examined. A discussion of the symptoms and clinical presentation of stroke is provided, as well as the current guideline for treatment of stroke in pregnancy. Finally, the data illustrating the recent increases in stroke incidence is outlined. PMID:23632643

  2. Evaluation of Clinical Innovation: A Gray Zone in the Ethics of Modern Clinical Practice?

    PubMed Central

    Grant, Andrew M.; Xhignesse, Marianne; Leblanc, Frédéric; Courteau, Josiane

    2007-01-01

    BACKGROUND Various stakeholders can have differing opinions regarding ethical review when introducing new procedures with patients. OBJECTIVE This pilot study examines the way in which Research Ethics Boards (REBs; Institutional Review Boards) and clinical biochemists (CBs; laboratory medicine specialists) differ in their interpretation of what is research and what should be considered common practice versus innovation versus experimentation when introducing new procedures with patients. It also explores whether these groups agree on who is responsible for the ethical review of new procedures. METHODS A validated case scenario for the introduction of a new diagnostic test into clinical practice was sent to CBs and REBs across Canada. Participants were asked to determine whether the scenario constituted research; whether the test procedure should be considered as experimental, innovative, or commonly accepted care; and whether the project required approval by a REB and, if not, who should be responsible for ethical review. RESULTS Results showed 81% of 37 CBs and 52% of 27 REBs identified the scenario as research. Responsibility for ethical review was assigned to REBs by 44% of REBs and 54% of CBs. Of all participants, 53% classified the test procedure as ‘innovative’, 8% as ‘experimental’, whereas 17% classified it as ‘commonly accepted’. CONCLUSIONS This pilot study indicates a substantial variation in the ethical assessment of innovation in clinical care. This suggests the need to further elaborate on the types of innovation in health care and categorize the nature of the risks associated with each. PMID:18095040

  3. Fulminant liver failure: clinical and experimental study.

    PubMed

    Slapak, M

    1975-11-01

    Clinical experience of some newer methods of hepatic support is described. The results are unpredictable and far from satisfactory. The need for an animal model in which potential therapeutic methods can be studied is emphasized. Such a model based on carefully imposed ischaemic insult to the liver in the absence of portacaval shunting is described. It is suggested that bacterial presence in the bowel together with a depression of the liver reticuloendothelial function plays an important part in the early and rapid mortality of acute liver failure. Temporary auxiliary liver transplantation using an allograft or a closely related primate heterograft seem to be the 2 best available methods of hepatic support for potentially reversible acute liver failure. PMID:812415

  4. Clinical studies of styrene workers: initial findings.

    PubMed Central

    Lorimer, W V; Lilis, R; Nicholson, W J; Anderson, H; Fischbein, A; Daum, S; Rom, W; Rice, C; Selikoff, I J

    1976-01-01

    Styrene monomer is a high volume chemical used chiefly in production of polystyrene. A clinical survey of 493 production workers was undertaken at the oldest and largest monomer production, polymerization, and extrusion facility in the U.S. Relative exposure durations and levels were obtained from occupational histories. Significant differences between the high and low exposure groups were found with regard to history of acute prenarcotic symptoms, acute lower respiratory symptoms, prevalence of FEV 1/FV less than 75 per cent, and elevated GCTP. Other liver function tests, chest x-ray, FVC less than 80 per cent, and hematological parameters showed no distinct pattern. A concomitant mortality study has been mounted and is in progress. PMID:1026403

  5. A Clinical Study of Miliary Brain Tuberculomas in China.

    PubMed

    Yang, Ming; Zhang, Jia-Tang; Yao, Yan; Tan, Qing-Che; Gao, Ting; Tian, Cheng-Lin; Huang, Xusheng; Yu, Sheng-Yuan

    2016-05-20

    Brain tuberculomas can exhibit many different clinical and radiological patterns. However, disseminated or miliary brain tuberculomas are very rare. Miliary brain tuberculomas have specific clinical prognostic implications. Seven patients diagnosed with miliary brain tuberculomas between December 2004 and August 2012 were evaluated retrospectively. Their clinical features, cranial magnetic resonance imaging (MRI) characteristics, treatments, and outcomes were reviewed. The median patient age was 42 years (range, 22-66 years). Six patients presented with fever, 5 with headache, 4 with papilledema, and 3 with diplopia. MRI studies revealed multiple brain lesions. MRI showed 20-50 lesions at the same level. These lesions measured approximately 2-4 mm in diameter and exhibited ring or nodular enhancement after gadolinium injection. All patients began to recover within 2 weeks of initiating antitubercular therapy (ATT). The number of lesions visible on MRI scans was halved within a month, and all lesions had healed without sequelae after 18 months of regular ATT. Miliary brain tuberculoma is a rare form of central nervous system tuberculosis. Some special characteristics of miliary brain tuberculomas are as follows: First, the presence of mild atypical clinical manifestations and almost normal laboratory findings; second, severe radiological features and 20-50 lesions at the same level on MRI scans; and third, a good response to standard ATT. Finally, they are benign; for instance, no patients died in our study. Early diagnosis and treatment can result in full recovery. PMID:26255731

  6. 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. PMID:16268392

  7. Oncolysis by paramyxoviruses: preclinical and clinical studies

    PubMed Central

    Matveeva, Olga V; Guo, Zong S; Senin, Vyacheslav M; Senina, Anna V; Shabalina, Svetlana A; Chumakov, Peter M

    2015-01-01

    Preclinical studies demonstrate that a broad spectrum of human malignant cells can be killed by oncolytic paramyxoviruses, which include cells of ecto-, endo-, and mesodermal origin. In clinical trials, significant reduction in size or even complete elimination of primary tumors and established metastases are reported. Different routes of viral administration (intratumoral, intravenous, intradermal, intraperitoneal, or intrapleural), and single- versus multiple-dose administration schemes have been explored. The reported side effects are grade 1 and 2, with the most common among them being mild fever. Some advantages in using paramyxoviruses as oncolytic agents versus representatives of other viral families exist. The cytoplasmic replication results in a lack of host genome integration and recombination, which makes paramyxoviruses safer and more attractive candidates for widely used therapeutic oncolysis in comparison with retroviruses or some DNA viruses. The list of oncolytic paramyxovirus representatives includes attenuated measles virus (MV), mumps virus (MuV), low pathogenic Newcastle disease (NDV), and Sendai (SeV) viruses. Metastatic cancer cells frequently overexpress on their surface some molecules that can serve as receptors for MV, MuV, NDV, and SeV. This promotes specific viral attachment to the malignant cell, which is frequently followed by specific viral replication. The paramyxoviruses are capable of inducing efficient syncytium-mediated lyses of cancer cells and elicit strong immunomodulatory effects that dramatically enforce anticancer immune surveillance. In general, preclinical studies and phase 1–3 clinical trials yield very encouraging results and warrant continued research of oncolytic paramyxoviruses as a particularly valuable addition to the existing panel of cancer-fighting approaches. PMID:26640815

  8. The wish to hasten death: a review of clinical studies.

    PubMed

    Monforte-Royo, Cristina; Villavicencio-Chávez, Christian; Tomás-Sábado, Joaquín; Balaguer, Albert

    2011-08-01

    It is common for patients who are faced with physical or psychological suffering, particularly those in the advanced stages of a disease, to have some kind of wish to hasten death (WTHD). This paper reviews and summarises the current state of knowledge about the WTHD among people with end-stage disease, doing so from a clinical perspective and on the basis of published clinical research. Studies were identified through a search strategy applied to the main scientific databases. Clinical studies show that the WTHD has a multi-factor aetiology. The literature review suggests-perhaps in line with better management of physical pain-that psychological and spiritual aspects, including social factors, are the most important cause of such a wish. One of the difficulties facing clinical research is the lack of terminological and conceptual precision in defining the construct. Indeed, studies frequently blur the distinction between a generic wish to die, a WTDH (whether sporadic or persistent over time), the explicit expression of a wish to die, and a request for euthanasia or physician-assisted suicide. A notable contribution to knowledge in this field has been made by scales designed to evaluate the WTHD, although the problems of conceptual definition may once again limit the conclusions, which can be drawn from the results. Studies using qualitative methodology have also provided new information that can help in understanding such wishes. Further clinical research is needed to provide a complete understanding of this phenomenon and to foster the development of suitable care plans. PMID:20821377

  9. 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

  10. Chronic Periodontal Disease May Influence the Pulp Sensitivity Response: Clinical Evaluation in Consecutive Patients

    PubMed Central

    Zuza, Elizangela Partata; Vanzato Carrareto, Ana Luiza; Pontes, Ana Emília Farias; Brunozzi, Marcelo; Pires, Juliana Rico; Toledo, Benedicto Egbert Corrêa

    2012-01-01

    Purpose. The aim of the present study was to evaluate the clinical response of the pulp in teeth with chronic periodontitis. Methods. Consecutive patients who had been admitted to the Clinics of Periodontology and fulfilled the criteria of inclusion were enrolled from January to December 2007. Ninety-eight single-root teeth from 27 patients with chronic periodontitis were evaluated clinically with regard to clinical attachment level (CAL), probing depth (PD), and gingival recession (REC). After periodontal measurements, Pulpal Sensitivity (PS) was evaluated with the use of a cooling stimulus test. Data was analyzed with Student's t test and contingency C coefficient. Results. Teeth that responded positively to PS test presented lower values of CAL (7.8 ± 2.8 mm), PD (5.0 ± 2.3 mm), and REC (2.8 ± 1.8 mm) in comparison to those that responded negatively (CAL = 12.0 ± 2.2 mm; PD = 7.9 ± 1.6 mm; REC = 4.1 ± 2.4 mm) (P < 0.01, Student's t test). In addition, significant correlations were observed between PS and periodontal parameters. Conclusions. Within the limits of this study, it could be suggested that the progression of periodontitis may significantly influence the negative pulpal response. PMID:22577567

  11. Knowledge-based biomedical word sense disambiguation: an evaluation and application to clinical document classification

    PubMed Central

    Garla, Vijay N; Brandt, Cynthia

    2013-01-01

    Background Word sense disambiguation (WSD) methods automatically assign an unambiguous concept to an ambiguous term based on context, and are important to many text-processing tasks. In this study we developed and evaluated a knowledge-based WSD method that uses semantic similarity measures derived from the Unified Medical Language System (UMLS) and evaluated the contribution of WSD to clinical text classification. Methods We evaluated our system on biomedical WSD datasets and determined the contribution of our WSD system to clinical document classification on the 2007 Computational Medicine Challenge corpus. Results Our system compared favorably with other knowledge-based methods. Machine learning classifiers trained on disambiguated concepts significantly outperformed those trained using all concepts. Conclusions We developed a WSD system that achieves high disambiguation accuracy on standard biomedical WSD datasets and showed that our WSD system improves clinical document classification. Data sharing We integrated our WSD system with MetaMap and the clinical Text Analysis and Knowledge Extraction System, two popular biomedical natural language processing systems. All codes required to reproduce our results and all tools developed as part of this study are released as open source, available under http://code.google.com/p/ytex. PMID:23077130

  12. 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...

  13. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 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...

  14. Erythroderma: A clinical study of 97 cases

    PubMed Central

    Akhyani, Maryam; Ghodsi, Zahra S; Toosi, Siavash; Dabbaghian, Hossein

    2005-01-01

    Background Erythroderma is a rare skin disorder that may be caused by a variety of underlying dermatoses, infections, systemic diseases and drugs. Methods We reviewed the clinical, laboratory and biopsy material of 97 patients diagnosed with erythroderma who were treated in our department over a 6-year period (1996 through 2002). Results The male-female ratio was 1.85:1. The mean age at diagnosis was 46.2 years. The most common causative factors were dermatoses (59.7%), followed by drug reactions (21.6%), malignancies (11.3%) and idiopathic causes (7.2%). Carbamazepine was the most common drug (57.1%). The best clinicopathologic correlation was found in cutaneous T-cell lymphoma and pityriasis rubra pilaris related erythroderma. Apart from scaling and erythema that were present in all patients, pruritus was the most common finding (97.5%), followed by fever (33.6%), lymphadenopathy (21.3%), edema (14.4%) and hyperkeratosis (7.2%). Conclusion This study outlines that underlying etiologic factors of erythroderma may show geographic variations. Our series had a high percentage of erythroderma secondary to preexisting dermatoses and a low percentage of idiopathic cases. There was no HIV-infected patient among our series based on multiple serum antibody tests. The clinical features of erythroderma were identical, irrespective of the etiology. The onset of the disease was usually insidious except in drug-induced erythroderma, where it was acute. The group associated with the best prognosis was that related to drugs. PMID:15882451

  15. 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. PMID:24396837

  16. Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials

    PubMed Central

    Lantos, John D.; Wendler, David; Septimus, Edward; Wahba, Sarita; Madigan, Rosemary; Bliss, Geraldine

    2015-01-01

    The classification system for categorizing the riskiness of a clinical trial is largely defined by the body of federal regulations known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration (FDA) codified in 21 CFR 50. This rule is applied according to the interpretation of institutional review boards (IRBs) charged with overseeing the research. If a clinical trial is determined by an IRB to constitute “minimal risk,” there are important practical implications: the IRB may allow 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 IRBs using an expedited process. However, it is unclear how the risk levels of pragmatic clinical trials (PCTs) should be assessed. 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 paper, we examine current research regulations and common interpretations of those regulations and suggest that current interpretation and application of regulations governing minimal-risk classification 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 clinical study. We then examine two studies that incorporate aspects of PCTs and consider how various factors including patient perspectives, clinical equipoise, practice variation, and research methods such as cluster randomization contribute to current and evolving concepts of minimal risk, and how this

  17. Evaluation of nisin-β-lactam antibiotics against clinical strains of Salmonella enterica serovar Typhi.

    PubMed

    Rishi, Praveen; Preet Singh, Aman; Garg, Neha; Rishi, Madhuri

    2014-12-01

    There is an imperative need to discover novel antimicrobials and anti-infective agents and build up innovative strategies to combat multidrug-resistant Salmonella. In this context, we had earlier confirmed that nisin has the potential to act in conjunction with β-lactams against murine salmonellosis using standard strain. However, evaluation of efficacy of these combinations against clinical isolates of Salmonella could be the next key step to confirm the value added potential of this peptide. The present study was therefore planned to validate the synergistic effects of nisin-β-lactams combinations against clinical isolates of Salmonella enterica serovar Typhi. MICs of the selected β-lactams, EDTA and nisin were determined by micro and macro broth dilution assays. In-vitro synergism between the agents was evaluated by fractional inhibitory concentration (FIC) index (checkerboard test) and time-kill assay. All the tested combinations showed synergy against the tested clinical strains except three, as evident by FIC index (checkerboard test) and time-kill assay. Especially, nisin-ceftriaxone and nisin-cefotaxime combinations demonstrated excellent synergistic activity. In view of the encouraging results obtained from the previous and present study, further studies need to be carried out using large number of strains from different regions to take into account the clinical variability of the strains. Though it is a simple study but highlights an important point about the possibility of using the said combination while making strategies to develop newer formulations. PMID:24961707

  18. [Clinical manifestations, complications and treatment of brucellosis: 45-patient study].

    PubMed

    Zribi, M; Ammari, L; Masmoudi, A; Tiouiri, H; Fendri, C

    2009-07-01

    The aim of this study was to evaluate the clinical, laboratory findings and therapeutic features of patients with brucellosis. The diagnosis was made by clinical findings, automated blood culture, serology (Rose Bengal plate agglutination test, standard tube agglutination (Wright) and immunofluorerescence). The susceptibility of 13 strains was tested in vitro. The base sequence was determined for four strains. Forty-five cases were collected (31 acute and 14 sub-acute). Contamination was digestive in 62%. Symptoms of patients were fever (93%), sweating (82%), arthralgia (78%) and splenomegaly (51%). Elevated erythrocyte sedimentation rate was determined in 80%, leukopenia in 49% and anaemia in 37% of cases. Blood cultures were positives in 39% of cases. The four sequenced strains were identified as Brucella melitensis biovar abortus. Six strains were resistant to sufomethoxazol-trimetoprim (54%). In 93% of cases, the treatment was associated rifampicin and doxycyclin. One patient died. No relapse was reported. PMID:18387752

  19. Evaluation of mtp40 genomic fragment amplification for specific detection of Mycobacterium tuberculosis in clinical specimens.

    PubMed Central

    Herrera, E A; Segovia, M

    1996-01-01

    A PCR assay based on the species-specific mtp40 genomic fragment was developed for the specific detection and identification of Mycobacterium tuberculosis in different uncultured clinical specimens. The aim of the study was to evaluate the clinical applicability of this target DNA in comparison with those of conventional microbiological methods and to compare the results obtained with those obtained after amplification with the IS6110 repetitive element. Discrepant results were interpreted in conjunction with the patients' clinical data, medical histories, and response to therapy. A total of 172 specimens from 162 patients with respiratory symptoms were tested, 101 specimens were obtained from 92 patients clinically suspected of having tuberculosis, and 71 specimens were obtained from 70 patients without known mycobacterial infection. The results of our study suggest that PCR amplification with the mtp40 genomic fragment provides a highly sensitive and specific technique for the detection of M. tuberculosis strains in clinical samples. It allows for the differentiation between M. tuberculosis and other related mycobacteria, including M. bovis, and is more specific than the IS6110 target. For these and other reasons, we propose that the mtp40 assay is a possible alternative for the specific direct detection of M. tuberculosis in clinical laboratories. PMID:8727885

  20. Pilot Study of a Clinical Pathway Implementation in Rectal Cancer

    PubMed Central

    Uña, Esther; López-Lara, Francisco

    2010-01-01

    Background: Rectal cancer is a highly prevalent disease which needs a multidisciplinary approach to be treated. The absence of specific protocols implies a significant and unjustifiable variability among the different professionals involved in this disease. The purpose is to develop a clinical pathway based on the analysis process and aims to reduce this variability and to reduce unnecessary costs. Methods: We created a multidisciplinary team with contributors from every clinical area involved in the diagnosis and treatment in this disease. We held periodic meetings to agree on a protocol based on the best available clinical practice guidelines. Once we had agreed on the protocol, we implemented its use as a standard in our institution. Every patient older than 18 years who was diagnosed with rectal cancer was considered a candidate to be treated via the pathway. Results: We evaluated 48 patients during the course of this study. Every parameter measured was improved after the implementation of the pathway, except the proportion of patients with 12 nodes or more analysed. The perception that our patients had about this project was very good. Conclusions: Clinical pathways are needed to improve the quality of health care. This kind of project helps reduce hospital costs and optimizes the use of limited resources. On the other hand, unexplained variability is also reduced, with consequent benefits for the patients. PMID:21151842

  1. Myopathies of endocrine disorders: A prospective clinical and biochemical study

    PubMed Central

    Sharma, Vikas; Borah, Papori; Basumatary, Lakshya J.; Das, Marami; Goswami, Munindra; Kayal, Ashok K.

    2014-01-01

    Introduction: Major categories of endocrine myopathy include those associated with: Adrenal dysfunction (as in Cushing's disease or steroid myopathy); thyroid dysfunction (as in myxedema coma or thyrotoxic myopathy); vitamin D deficiency; parathyroid dysfunction; and pituitary dysfunction. Steroid myopathy is the most common endocrine myopathy. Objective: To study the etiology, varied presentations, and outcome after therapy of patients with endocrine myopathies. Materials and Methods: Myopathy was evaluated by the standard clinical procedures: Detailed clinical history, manual muscle strength testing, and creatine phosphokinase (CPK). Endocrine disorders were diagnosed as per clinical features and biochemical parameters. The treatment was given to patients as per underlying endocrine disease. Myopathy was assessed before and after treatment. Results: Out of the 37 patients who were diagnosed with endocrine myopathies, thyroid dysfunction was the most common cause (17 cases), followed by vitamin D deficiency in nine, adrenal dysfunction in six, parathyroid dysfunction in three, and pituitary dysfunction in two. Some patients had atypical presentation (repeated falls in one, tongue fasciculations in one, neck weakness in five, one with ptosis and facial weakness, asymmetrical onset in one, and calf hypertrophy in one. The serum creatine kinase (CK) concentration did not correlate with muscle weakness. Following the treatment regimen which was specific for a given myopathy, 26 patients recovered fully. Conclusion: We found varied clinical presentations of endocrine myopathies. All the patients with neuromuscular complaints should be investigated for endocrine causes because significant number of them recovers fully with specific treatment. PMID:25221399

  2. [Clinical and microbiological study of adult periodontal disease].

    PubMed

    Nogueira Moreira, A; Fernández Canigia, L; Furman, C; Chiappe, V; Marcantoni, M; Bianchini, H

    2001-01-01

    The aim of this study was to carry out a microbiological evaluation of sites with and without clinical evidence of moderate and severe periodontitis and their correlation with clinical parameters. A total of 52 disease sites and 10 healthy sites were selected according to clinical criteria. The following clinical indexes were measured for all the sites: plaque index, gingival index, blood on probing, depth on probing and insertion level. Samples of subgingival plaque were collected for culture and for differential counts of microbial morphotypes. In disease sites the most frequently isolated were: Prevotella intermedia/nigrescens (65%), Porphyromonas gingivalis (23%), Actinobacillus actinomycetemcomitans (23%), Fusobacterium nucleatum (10%) and Peptostreptococcus sp. (31%). The aerobic gram-positive microflora was predominant in healthy sites. Significant differences were observed in microbial morphotypes between healthy and disease sites: cocci 18.71% and 78.90%, motile rods 46.12% and 16.70%, total spirochetes 26.48% and 2.80%, respectively. The presence of motile rods, spirochetes and P. intermedia/nigrescens were the parameters with most sensitivity to suspect periodontal disease. There were significant differences in the subgingival microflora between healthy and disease sites in patients with moderate and severe periodontitis. PMID:11594003

  3. Bioplastique at 6 years: clinical outcome studies.

    PubMed

    Ersek, R A; Gregory, S R; Salisbury, A V

    1997-11-01

    Bioplastique is a biphasic polymer for the permanent augmentation of some soft tissues. It was developed in 1987, and clinical studies at this institution were begun in 1990. The combination of low molecular weight polyvinylpyrrolidone and solid polymer particles allows the implantation of permanent polymer spheres through a small needle under local anesthesia. In this study 127 cases are reviewed of consecutive patients who have received Bioplastique for scar revision, wrinkles, and augmentation for soft-tissue defects at 6 years after application. All patients who had not been in for follow-up recently were contacted by mail and questioned on the permanence of augmentation and migration of particles. About 30 percent of the patients were unreachable and had their charts reviewed for permanence and migration of particles. In eight of these cases, Bioplastique was removed because of overcorrection, two of them may have had infection. Bioplastique has gained wide use throughout the world and although some complications have been reported, in general, it functions quite well when used in selected cases. PMID:9385974

  4. Evaluation of Bacterial Contamination in a Clinical Environment

    PubMed Central

    Umar, Dilshad; Basheer, Bahija; Husain, Akther; Baroudi, Kusai; Ahamed, Fareed; Kumar, Amit

    2015-01-01

    Background: Although the contamination of the dental environment and personnel through aerosol contamination is a definite source of cross contamination; there is little data on the microbial involvement of the dental environment. Materials and Methods: A total of 100 samples were taken from various inanimate surfaces in the clinical dental setting were collected aseptically by rotating sterile swabs moistened with peptone water over the surfaces of the samples and then inoculated into brain heart infusion broth and incubated at 37°C aerobically overnight. Subcultures were made on 5% sheep blood agar and MacConkey agar plates and incubated at 37°C for 24 h. Growth in the plates was observed. Results: Out of the 100 samples screened in this study, a bacterial agent was observed in 38 samples, and 62 samples showed no growth. A higher percentage of contamination was seen on the dental chair light handles, suction tips and the pens used by the dental health care personnel’s, followed by the instruments and the laboratory equipment. Conclusion: Establishing an effective preventive strategies for well-practiced infection control is essential to prevent nosocomial infections and promote a safe environment in the dental clinics. PMID:25709369

  5. How do chiropractors manage clinical risk? A questionnaire study

    PubMed Central

    2013-01-01

    Background The literature on chiropractic safety tends to focus on adverse events and little is known about how chiropractors ensure safety and manage risk in the course of their daily practice. The purpose of this study was to investigate how chiropractors manage potentially risky clinical scenarios. We also sought to establish how chiropractors perceive the safety climate in their workplace and thus whether there is an observable culture of safety within the profession. Methods An online questionnaire was designed to determine which of nine management options would be chosen by the respondent in response to four defined clinical case scenarios. Safety climate within the respondent’s practice setting was measured by seeking the level of agreement with 23 statements relating to six different safety dimensions. 260 licensed chiropractors in Switzerland and 1258 UK members of The Royal College of Chiropractors were invited to complete the questionnaire. Questionnaire responses were analysed quantitatively in respect of the four clinical scenarios and the nine management options to determine the likelihood of each option being undertaken, with results recorded in terms of % likelihood. Gender differences in response to the management options for each scenario were evaluated using the Mann–Whitney U (MWU) test. Positive agreement with elements comprising each of the six safety dimensions contributed to a composite ‘% positive agreement’ score calculated for each dimension. Results Questionnaire responses were received from 76% (200/260) of Swiss participants and 31% (393/1258) of UK members of The Royal College of Chiropractors. There was a general trend for Swiss and UK chiropractors to manage clinical scenarios where treatment appears not to be successful, not indicated, possibly harmful or where a patient is apparently getting worse, by re-evaluating their care. Stopping treatment and/or incident reporting to a safety incident reporting and learning system

  6. Rotational laxity after anterior cruciate ligament injury by kinematic evaluation of clinical tests.

    PubMed

    Zaffagnini, S; Martelli, S; Falcioni, B; Motta, M; Marcacci, M

    2000-01-01

    Despite the numerous studies on anterior cruciate ligament biomechanics and clinical tests, some disagreements still exist in the literature on the role of ACL in restraining rotations and which kinematic test after ACL injuries is the most suitable to evaluate this instability. This work analyses the capability of passive clinical and stress tests to detect an ACL state quantifying rotational instability. The study was conducted on animal knees with a new protocol. We found that an internal-external stress test can give a useful indication on the ACL state when used to estimate the side to side differences while varus-valgus laxity and secondary motions in standard kinematic tests did not seem to be affected by ACL injury. The kinematic protocol performed could be used intra-operatively to quantify rotations, allowing a more accurate evaluation of knee instability to guide surgical reconstruction and improve its final outcome. PMID:11204247

  7. Accuracy and Robustness Improvements of Echocardiographic Particle Image Velocimetry for Routine Clinical Cardiac Evaluation

    NASA Astrophysics Data System (ADS)

    Meyers, Brett; Vlachos, Pavlos; Charonko, John; Giarra, Matthew; Goergen, Craig

    2015-11-01

    Echo Particle Image Velocimetry (echoPIV) is a recent development in flow visualization that provides improved spatial resolution with high temporal resolution in cardiac flow measurement. Despite increased interest a limited number of published echoPIV studies are clinical, demonstrating that the method is not broadly accepted within the medical community. This is due to the fact that use of contrast agents are typically reserved for subjects whose initial evaluation produced very low quality recordings. Thus high background noise and low contrast levels characterize most scans, which hinders echoPIV from producing accurate measurements. To achieve clinical acceptance it is necessary to develop processing strategies that improve accuracy and robustness. We hypothesize that using a short-time moving window ensemble (MWE) correlation can improve echoPIV flow measurements on low image quality clinical scans. To explore the potential of the short-time MWE correlation, evaluation of artificial ultrasound images was performed. Subsequently, a clinical cohort of patients with diastolic dysfunction was evaluated. Qualitative and quantitative comparisons between echoPIV measurements and Color M-mode scans were carried out to assess the improvements delivered by the proposed methodology.

  8. [Clinical and histopathologic study of salivary mucoceles].

    PubMed

    Kang, S K; Kim, K S

    1989-11-01

    Mucoceles are commonly occurring lesions of the oral mucous membrane and the most common lesion involving minor salivary tissue. The incidence of mucoceles is understandable since accessary salivary gland tissue is widely distributed throughout the oral mucous membrane and trauma to the mucosa, which causes their formation, occurs frequently. But only a few studies have been reported that describe its detailed features. This is a retrospective study on the salivary mucoceles in the oral mucous membrane and based on clinical chart, biopsy request and photomicroscopic finding of 112 patients treated by Dept. of Oral Surgery in Seoul National University Hospital, during the period of last 10 years. The results were as following. 1. The age range of the 112 patients was 2 to 60 years, with a peak incidence in the second decade and a gradual decline thereafter. Of the 112 patients, 49 (44%) were males and 63 (56%) were females, the male-to-female ratio being 1:1.29. 2. The majority of these lesions were located on the lower lip but occurred with lesser frequently on the buccal mucosa, floor of the mouth, tongue, retromolar region, upper lip. 3. Of the 112 patients, 107 (95%) were treated by excision and only 5 were treated by marsupialization. 18 of 112 cases had recurrence and the recurrence rate in this study was 16%. 4. Only 3 of the 112 cases revealed an epithelial lining. This incidence indicates that the mucus-extravasation by the damage of excretory duct rather than the ductal dilatation by mucus-retention may play a critical role in the production of these lesions. 5. In 81 cases (72.3%) minor salivary gland were included in the excision biopsy, specimen. Changes observed in the glandular tissue were atrophy and infiltration of chronic inflammatory cell, but the secretory function of gland was thought to be normal in most cases because the changes were mild. PMID:2489621

  9. Effects of structured written feedback by cards on medical students’ performance at Mini Clinical Evaluation Exercise (Mini-CEX) in an outpatient clinic

    PubMed Central

    HAGHANI, FARIBA; HATEF KHORAMI, MOHAMMAD; FAKHARI, MOHAMMAD

    2016-01-01

    Introduction Feedback cards are recommended as a feasible tool for structured written feedback delivery in clinical education while effectiveness of this tool on the medical students’ performance is still questionable.  The purpose of this study was to compare the effects of structured written feedback by cards as well as verbal feedback versus verbal feedback alone on the clinical performance of medical students at the Mini Clinical Evaluation Exercise (Mini-CEX) test in an outpatient clinic. Methods This is a quasi-experimental study with pre- and post-test comprising four groups in two terms of medical students’ externship. The students’ performance was assessed through the Mini-Clinical Evaluation Exercise (Mini-CEX) as a clinical performance evaluation tool. Structured written feedbacks were given to two experimental groups by designed feedback cards as well as verbal feedback, while in the two control groups feedback was delivered verbally as a routine approach in clinical education. Results By consecutive sampling method, 62 externship students were enrolled in this study and seven students were excluded from the final analysis due to their absence for three days. According to the ANOVA analysis and Post Hoc Tukey test,  no statistically significant difference was observed among the four groups at the pre-test, whereas a statistically significant difference was observed between the experimental and control groups at the post-test  (F = 4.023, p =0.012). The effect size of the structured written feedbacks on clinical performance was 0.19. Conclusion Structured written feedback by cards could improve the performance of medical students in a statistical sense. Further studies must be conducted in other clinical courses with longer durations. PMID:27382581

  10. Clinical evaluation of juvenile delinquents: who gets court referred?

    PubMed

    Barnum, R; Famularo, R; Bunshaft, D; Fenton, T; Bolduc, S

    1989-01-01

    This study examines which alleged delinquents in a large urban juvenile court are selected for referral to the court's psychiatric clinic. A number of demographic factors, probation officer impressions, index charges, and past delinquency record variables were examined for all minor delinquency cases referred in a six-month period and for a random selection of nonreferred cases. In general, referral was associated with lower socioeconomic status (SES), and with a variety of probation impressions of child and family dysfunction. Little relation to index charge or past record was found. The authors interpret these results as showing that probation referrals appear to be made more on the basis of high risk than on the basis of favorable prognosis for treatment. PMID:2605360

  11. Narrative interpretations for clinical laboratory evaluations: an overview.

    PubMed

    Dighe, A S; Soderberg, B L; Laposata, M

    2001-12-01

    As the clinical laboratory test menu has significantly expanded in volume and complexity, there is a rapidly growing need by clinicians for narrative interpretations of complex studies that resemble those provided in anatomic pathology and radiology. In this report, the impact of advice on laboratory test selection and interpretation is presented with regard to providing adequate quality of care, reducing medical error, and reducing the cost for health care. In addition, past and current attempts to address the physician's need for advice on laboratory test selection and interpretation are also described. These include curbside consultations, intelligent laboratory information systems, and medical information from the Internet. Each is presented with examples from the literature and with its advantages and disadvantages for practicing clinicians confronting large, expensive test menus and the results of esoteric assays. PMID:11993697

  12. Understanding Orthopaedic Registry Studies: A Comparison with Clinical Studies.

    PubMed

    Inacio, Maria C S; Paxton, Elizabeth W; Dillon, Mark T

    2016-01-01

    Orthopaedic registries are valuable for monitoring patient outcomes in real-world settings. Registries are useful for identifying procedure incidence and device utilization, evaluating outcomes, determining patients at risk for complications and reoperations, identifying devices in recall situations, assessing comparative effectiveness of procedures and devices, and providing data for research studies. In the present report, we describe how orthopaedic registries can be used to conduct research and how they compare with randomized controlled trials (RCTs) in regard to methodology. Using an example, a comparison of the performance of mobile and fixed bearings in total knee arthroplasty, we evaluate the differences between, and the similarities of, RCTs and registry cohort studies with regard to how they are conducted and how their findings are reported. Orthopaedic registry studies differ from RCTs in many ways and offer certain advantages. The strengths and limitations of registry cohort studies and RCTs must be understood to properly evaluate the literature. PMID:26738910

  13. Evaluation of children's dental anxiety levels at a kindergarten and at a dental clinic.

    PubMed

    Kilinç, Gulser; Akay, Aynur; Eden, Ece; Sevinç, Nilgün; Ellidokuz, Hülya

    2016-01-01

    This study evaluated the dental anxiety levels of preschool children at a kindergarten and at a dental clinic. The anxiety levels of ninety 4-6-year-old (4.99 ± 0.81) preschool children were evaluated according to pulse rates, the facial image scale (FIS), the Venham picture test (VPT), and the Frankl behavior rating scale. The children's mothers were asked to complete the state-trait anxiety inventory (STAI) forms 1 and 2 (STAI 2 and STAI 2). The sample t-test, Mann-Whitney U test, and Pearson's correlation test were used. A statistically significant difference was observed between the children's pulse rates when measured at the dental clinic and those when measured at the kindergarten (p < 0.001). Although the results were not statistically significant, more negative facial expressions were observed in the children at the dental clinic than in those at the kindergarten when assessed using FIS and VPT (p = 0.090 and p = 0.108, respectively). There was a statistically significant correlation between the transient anxiety levels (STAI 1) of mothers and the VPT scores of their children evaluated at the dental clinic (r = 0.506, p < 0.001). The continuous anxiety level of the mothers of males was found to be significantly higher (p = 0.033) than that of the mothers of females (STAI 2). Although the children had been informed about dentistry and were introduced to a dentist at the kindergarten, their anxiety levels seemingly increased as they arrived at the dental clinic. The significant increase observed in the children's pulse rates was a physical indicator that their anxiety levels had increased. It can be concluded that the children felt more anxious at the dental clinic that at the kindergarten. PMID:27556551

  14. Diagnostic Value of Clinical Findings in Evaluation of Thoracolumbar Blunt Traumas

    PubMed Central

    Shahrami, Ali; Shojaee, Majid; Tabatabaee, Seyed Mohammadreza; Mianehsaz, Elaheh

    2016-01-01

    Introduction: Necessity of imaging for symptom-free conscious patients presented to emergency department (ED) following traumatic thoracolumbar spine injuries has been a matter of debate. The present study was aimed to evaluate the diagnostic value of clinical findings in prediction of traumatic thoracolumbar injuries compared tocomputed tomography (CT) scan. Methods: The present diagnostic value study was carried out using non-random convenience sampling during the time between October 2013 and March 2014. All trauma patients > 15 years old underwent thoracolumbar CT scan were included. Correlation between clinical and CT findings was measured using SPSS 21.0 and screening performance characteristics of clinical findings in prediction of thoracolumbar fracture were calculated. Results: 169 patients with mean age of 37.8 ± 17.3 years (rage: 15-86) were evaluated (69.8% male). All fracture patients had at least 1 positive finding in history and physical examination. The fracture was confirmed in only 24.6% of the patients with positive findings in history or physical examination. In 37.5% of patients the location of fracture, matched the area of positive physical examinations. Sensitivity, specificity, PPV, NPV, PLR, and NLR of clinical findings in comparison to thoracolumbar CT scan were 100 (95% CI: 89 - 100), 1.5 (95% CI: 0.2-6), 24.5 (95% CI: 18.3-31.9), 100 (95% CI: 19.7-100), 32.5 (95% CI: 24.6-43.03), and infinite, respectively. Conclusion: The results of the present study, show the excellent screening performance characteristics of clinical findings in prediction of traumatic thoracolumbar fracture (100% sensitivity). It could be concluded that in conscious patients with stable hemodynamic, who have no distracting pain and are not intoxicated, probability of thoracolumbar fracture is very low and near to zero in case of no positive clinical finding. PMID:27299140

  15. Neurophysiology versus clinical genetics in Rett syndrome: A multicenter study.

    PubMed

    Halbach, Nicky; Smeets, Eric E; Julu, Peter; Witt-Engerström, Ingegerd; Pini, Giorgio; Bigoni, Stefania; Hansen, Stig; Apartopoulos, Flora; Delamont, Robert; van Roozendaal, Kees; Scusa, Maria F; Borelli, Paolo; Candel, Math; Curfs, Leopold

    2016-09-01

    Many studies have attempted to establish the genotype-phenotype correlation in Rett syndrome (RTT). Cardiorespiratory measurements provide robust objective data, to correlate with each of the different clinical phenotypes. It has important implications for the management and treatment of this syndrome. The aim of this study was to correlate the genotype with the quantitative cardiorespiratory data obtained by neurophysiological measurement combined with a clinical severity score. This international multicenter study was conducted in four European countries from 1999 to 2012. The study cohort consisted of a group of 132 well-defined RTT females aged between 2 and 43 years with extended clinical, molecular, and neurophysiological assessments. Diagnosis of RTT was based on the consensus criteria for RTT and molecular confirmation. Genotype-phenotype analyses of clinical features and cardiorespiratory data were performed after grouping mutations by the same type and localization or having the same putative biological effect on the MeCP2 protein, and subsequently on eight single recurrent mutations. A less severe phenotype was seen in females with CTS, p.R133C, and p.R294X mutations. Autonomic disturbances were present in all females, and not restricted to nor influenced by one specific group or any single recurrent mutation. The objective information from non-invasive neurophysiological evaluation of the disturbed central autonomic control is of great importance in helping to organize the lifelong care for females with RTT. Further research is needed to provide insights into the pathogenesis of autonomic dysfunction, and to develop evidence-based management in RTT. © 2016 Wiley Periodicals, Inc. PMID:27354166

  16. Using Clinical Gait Case Studies to Enhance Learning in Biomechanics

    ERIC Educational Resources Information Center

    Chester, Victoria

    2011-01-01

    Clinical case studies facilitate the development of clinical reasoning strategies through knowledge and integration of the basic sciences. Case studies have been shown to be more effective in developing problem-solving abilities than the traditional lecture format. To enhance the learning experiences of students in biomechanics, clinical case…

  17. Prognostic evaluation by clinical exercise test scores in patients treated with primary percutaneous coronary intervention or fibrinolysis for acute myocardial infarction (a Danish Trial in Acute Myocardial Infarction-2 Sub-Study).

    PubMed

    Valeur, Nana; Clemmensen, Peter; Grande, Peer; Saunamäki, Kari

    2007-10-01

    The prognostic accuracy of exercise testing after myocardial infarction is low, and different models have been proposed to enhance the predictive value for subsequent mortality. This study tested a simple score against 3 established scores. Patients with ST-elevation myocardial infarctions were randomized in the Danish Trial in Acute Myocardial Infarction-2 (DANAMI-2) to either primary percutaneous coronary intervention or fibrinolysis with predischarge exercise testing. Clinical and exercise test data were collected prospectively and were available for 1,115 patients. A simple score was derived, awarding 1 point for history or new signs of heart failure, 1 point for a left ventricular ejection fraction <40%, 1 point for age >65 years in men and age >70 years in women, and 1 point for exercise capacity <5 METs in men and exercise capacity <4 METs in women. This DANAMI score was compared with the Veterans Affairs Medical Center score, the Duke treadmill score, and the Gruppo Italiano per lo Studio Della Sopravvivenza nell'Infarto Miocardico-2 (GISSI-2) score in multivariate Cox models and receiver-operating characteristic plots. All scoring systems were predictive of adverse outcomes. The DANAMI score performed better, with greater chi-square values (142 vs 53 to 88 for the prediction of death). Areas under the receiver-operating characteristic curves were compared and were larger for the DANAMI score (C-statistic 0.79 vs 0.71 to 0.74 for the other tests regarding mortality). The DANAMI score stratified patients into a small high-risk group (8% of the population with 43% mortality in 6 years), an intermediate-risk group (13% with 16% mortality in 6 yea