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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 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

  8. 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

  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. 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

  6. 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

  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. [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

  13. 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.

  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. 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

  18. 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

  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. 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

  14. Genetic and clinical evaluation of juvenile retinoschisis

    PubMed Central

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

    2014-01-01

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

  15. 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

  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

    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 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

  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. 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

  7. 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

  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