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Sample records for clinical evaluation study

  1. Clinical Applications of Evaluation Studies.

    ERIC Educational Resources Information Center

    Brown, Barry S.

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

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

    PubMed

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

    2014-01-01

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

  3. Clinical evaluation--difficulties experienced by sessional clinical teachers of nursing: a qualitative study.

    PubMed

    Duke, M

    1996-02-01

    Evaluation of nursing students in the clinical field requires the clinical teacher to make judgements regarding student progress in a number of areas. In this study concepts of role theory, oppressed group behaviour and the ethics of caring emerged and were used as conceptual frameworks to interpret the data relating to the evaluation of undergraduate students. The number of experienced faculty available for clinical teaching and evaluation has become inadequate and a large number of casual or sessional clinical teachers are employed to teach students in the clinical field. Despite the well documented problems associated with clinical teaching and the use of inexperienced clinical teachers, sessional clinical teachers are nevertheless expected to evaluate student success in meeting the clinical requirements of the nursing course, often resulting in disparate decisions for students. A phenomenological study was carried out using unstructured interviews and written clinical scenarios, to explore the evaluation process from the perspective of the sessional clinical teachers. Research findings indicate that although the sessional clinical teachers were skilled at identifying student problems, they were reluctant to make difficult evaluation decisions, due to low self-esteem, role conflict and their ethic of caring. It seems that gender socialization, patriarchal dominance and apprenticeship training had effected their confidence in their own decision making. The implications of such findings are of concern for the ongoing credibility and integrity of nursing courses, as clinical teachers have an influence on the nursing profession through the preparation of its practitioners.

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

    PubMed

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

    2011-01-01

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

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

    PubMed

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

    2014-09-01

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

  6. 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...

  7. 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...

  8. 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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

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

  10. 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...

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

    PubMed Central

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

    2016-01-01

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

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

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

  13. 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...

  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 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...

  16. 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...

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

    PubMed

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

    2015-01-01

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

  1. 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

  2. [The evaluation of cefmetazole in clinical use. The study group of cefmetazole in clinical use].

    PubMed

    Si, C; Tian, G

    1996-10-01

    To study the clinical effect of cefmetazole (CMZ), we treated with CMZ 1,926 patients with various infections involving the respiratory tract, gastrointestinal tract, liver and biliary tract, skin and soft tissue and others. The marked effect rate was 56.5%, and the effect rate 33.7%. The sensitivity test of CMZ was also performed in vitro. Staphylococcus aureus, streptococcus, staphylococcus epidermis, E. coli, S. typhi, B. salmonella, B. shigella, B. Klebsiella pneumoniae, B. proteus, etc. were sensitive to CMZ. Injecting CMZ can prevent the infection of operation. The study of the adverse reaction of CMZ showed, an adverse reaction rate of 4.2% (the gastrointestinal tract, allergy, kidney and nervous system). These results suggested that CMZ is an antibiotic of broad spectrum, high efficacy and low toxicity. It is effective in treating sensitive bacterial infection, unknown pathogenic infection and mixed bacterial infection, and preventing infection in surgery. PMID:9592326

  3. 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.

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

    PubMed

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

    2012-01-01

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

  5. Evaluation of clinical pathology data: correlating changes with other study data.

    PubMed

    Everds, Nancy E

    2015-01-01

    During the conduct of in vivo toxicology studies, in-life, clinical pathology, and anatomic pathology parameters are collected and interpreted. These sets of parameters are evaluated in an integrative manner to determine the overall toxicity of a test article. For clinical pathology parameters, the inherent variability and physiologic factors affecting each analyte must be understood prior to interpretation. Changes in clinical pathology parameters that are considered to be test article-related are then assessed with respect to changes in the concurrent data sets such as clinical signs and anatomic pathology to determine the underlying pathophysiology. In this article, examples of hemolysis and hepatotoxicity are used to demonstrate the relationships among the various parameters and data sets. Whereas there was tight correlation of all data sets in the example of hemolysis in rats, the examples of altered enzymes and other biomarkers indicating liver injury and dysfunction were more often discordant with other data sets.

  6. 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…

  7. Evaluation of Clinical Competence.

    ERIC Educational Resources Information Center

    Newble, David I.

    In Australia the usual evaluation of whether a student will perform adequately as a doctor is a subjective evaluation of his clinical performance, usually at the completion of five or six years at medical school. The evaluation is performed on an inadequate and uncontrolled patient sample and appears to be subject to many errors. Recent work…

  8. 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.

  9. 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

  10. Evaluating Student Clinical Performance.

    ERIC Educational Resources Information Center

    Foster, Danny T.

    When the University of Iowa's athletic training education department developed evaluation criteria and methods to be used with students, attention was paid to validity, consistency, observation, and behaviors. The observations of student behaviors reflect three types of learning outcomes important to clinical education: cognitive, psychomotor, and…

  11. 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

  12. 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

  13. 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

  14. 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

  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. 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.

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

    PubMed Central

    2012-01-01

    Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

  19. 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

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

    PubMed

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

    2013-11-01

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

  1. Therapeutic evaluation of sustained-releasing praziquantel (SRP) for clonorchiasis: Phase 1 and 2 clinical studies

    PubMed Central

    Choi, Min-Ho; Chang, Byung-Chan; Lee, Seung-Jin; Jang, In-Jin; Shin, Sang-Goo; Kho, Weon-Gyu; Chun, Jin-Ho

    2006-01-01

    Sustained-releasing praziquantel (SRP) tablet was designed for single dose treatment regimen of clonorchiasis. A previous pre-clinical study confirmed its sustained-releasing characteristics and a better cure rate than conventional praziquantel (PZQ). In this clinical study, the pharmacokinetics of this SRP tablet were investigated in human volunteers (phase 1; 12 volunteers), and its curative efficacy was examined in clonorchiasis patients (phase 2; 20 volunteers). In the phase 1 clinical study, blood concentrations of both tablets showed wide individual variation. The AUClast of SRP was 497.9 ± 519.0 ng · hr/ml (mean ± SD) and PZQ of 628.6 ± 695.5 ng · hr/ml, and the AUCinf of SRP was 776.0 ± 538.5 ng · hr/ml and of PZQ 658.6 ± 709.9 ng · hr/ml. Cmax values of SRP and PZQ were 90.7 ± 82.2 ng/ml and 214.9 ± 251.9 ng/ml, and Tmax values were 3.42 ± 1.43 hr and 1.96 ± 1.23 hr, respectively. SRP tablets showed similar AUC values, but lower Cmax and longer Tmax values than PZQ. In the phase 2 study, SRP at 30 mg/kg (single dose) achieved a 60% cure rate and a 95.5% egg reduction rate. The cure rate of a single dose SRP was unsatisfactory compared with that of the conventional PZQ dose, but much better than that achieved by a single dose PZQ. PMID:17170578

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

    PubMed

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

    1997-07-01

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

  3. Clinical evaluation and prerelease management of American river otters in the second year of a reintroduction study.

    PubMed

    Hoover, J P; Bahr, R J; Nieves, M A; Doyle, R T; Zimmer, M A; Lauzon, S E

    1985-12-01

    In the first year (1984) of a reintroduction study, 10 American river otters (Lutra canadensis) from Louisiana were transported to Oklahoma, held for 5 days for clinical evaluation, surgical implantation with intra-abdominal radiotelemetry devices, and then released in Oklahoma. Four of 10 otters released died within 32 days. Clinical evaluation indicated that respiratory tract disease, bacterial and parasitic infections, and inanition may have contributed to the death of these otters. In the second year (1985) of the study, an exotic feline diet was fed, and the holding period for 10 otters was increased to provide time for evaluation and treatment before surgery, postsurgical acclimation to Oklahoma, and reevaluation before release. Although the initial clinical findings on otters in the second year were similar to those found in the first year, otter body weights increased, and the prevalence and severity of clinical abnormalities decreased with treatment during the second-year holding period. Three of 10 second-year otters died during the holding period, and contributing causes of death were determined to be: trauma (hepatic hematoma), inanition, renal disease, pneumonia, salmonellosis (Salmonella anatum), and a retropharyngeal abscess (Klebsiella pneumoniae). Seven healthy otters were reintroduced into Oklahoma in 1985, and postrelease deaths were not experienced.

  4. Clinical Evaluation of Eye Movements in Spinocerebellar Ataxias: A Prospective Multicenter Study

    PubMed Central

    Moscovich, M.; Okun, Michael S.; Favilla, Chris; Figueroa, Karla P.; Pulst, Stefan M.; Perlman, Susan; Wilmot, George; Gomez, Christopher; Schmahmann, Jeremy; Paulson, Henry; Shakkottai, Vikram; Ying, Sarah; Zesiewicz, Theresa; Kuo, S. H.; Mazzoni, P.; Bushara, Khalaf; Xia, Guangbin; Ashizawa, Tetsuo; Subramony, S. H.

    2015-01-01

    Background Ocular motor abnormalities reflect the varied neuropathology of spinocerebellar ataxias (SCAs) and may serve to clinically distinguish the different SCAs. We analyzed the various eye movement abnormalities detected prospectively at the baseline visit during a large multicenter natural history study of SCAs 1, 2, 3, and 6. Methods The data were prospectively collected from 12 centers in the United States in patients with SCAs 1, 2, 3, and 6, as part of the Clinical Research Consortium for Spinocerebellar Ataxias (NIH-CRC-SCA). Patient characteristics, ataxia rating scales, the Unified Huntington Disease Rating Scale functional examination, and clinical staging were used. Eye movement abnormalities including nystagmus, disorders of saccades and pursuit, and ophthalmoparesis were recorded, and factors influencing their occurrence were examined. Results A total of 301 patients participated in this study, including 52 patients with SCA 1, 64 with SCA 2, 117 with SCA 3, and 68 with SCA 6. Although no specific ocular motor abnormality was pathognomonic to any SCA, significant differences were noted in their occurrence among different disorders. SCA 6 was characterized by frequent occurrence of nystagmus and abnormal pursuit and rarity of slow saccades and ophthalmoparesis and SCA 2 by the frequent occurrence of slow saccades and infrequent nystagmus and dysmetric saccades. SCA 1 and SCA 3 subjects had a more even distribution of eye movement abnormalities. Conclusions Prospective data from a large cohort of patients with SCAs 1, 2, 3, and 6 provide statistical validation that the SCAs exhibit distinct eye movement abnormalities that are useful in identifying the genotypes. Many of the abnormalities correlate with greater disease severity measures. PMID:25259863

  5. [Follow-up studies and clinical evaluation of model cast dentures with periodontal and periodonto-gingival support].

    PubMed

    Ebersbach, W; Lesche, M

    1977-11-01

    The authors examined 746 cast denture constructions with an average wearing time of 6 years to study the influence of cast denture constructions on caries increment. The mode of wear of the cast denture constructions had no influence on caries incidence, whereas effects exerted by the duration of wear and the presence of soft deposits could be detected. The evaluation of the functional performance of cast denture constructions showed that the clinical serviceability amounts to more than 8 years.

  6. A cardiac evoked response algorithm providing threshold tracking: a North American multicenter study. Clinical Investigators of the Microny-Regency Clinical Evaluation Study.

    PubMed

    Lau, C; Cameron, D A; Nishimura, S C; Ahern, T; Freedman, R A; Ellenbogen, K; Greenberg, S; Baker, J; Meacham, D

    2000-06-01

    The purpose of this study was to evaluate a pacing system using the recognition of cardiac evoked response for the automatic adjustment of pacing output. Patients were prospectively followed after primary implantation of VVIR pacemakers using AutoCapture (St. Jude Medical CRMD). Sensing and pacing thresholds, polarization signal, evoked response, and AutoCapture performance were evaluated with serial visits and 24-hour Holter monitoring. Three hundred ninety-eight patients (mean age 71 +/- 15 years) were followed for an average duration of 1 year (3 days-1.75 years) with the algorithm functional in > 90% of patients. Backup pacing in the event of exit block was confirmed in all patients. Pacing thresholds remained stable at 0.89 +/- 0.34 V with a pulse width of 0.31 ms (with chronic output autoset at 0.3 V above the actual threshold). Evoked response exhibited a small but statistically significant increase with time (8.92 mV at implant, 9.60 mV at 12 months), however, this finding did not result in any change in AutoCapture function during our follow-up period. The polarization signal remained stable with minimal variation (1.12 mV at implant, 1.18 at 12 months). No clinical adverse events were observed using the AutoCapture algorithm. In this initial experience with the AutoCapture algorithm the evoked response and polarization measurements remained adequate, allowing the system to function in the majority of patients with safe, low output pacing. High energy backup pacing provided an added safety feature over fixed output devices in cases of unexpected threshold rises. Longer follow-up is required for continued long-term validation of the algorithm. PMID:10879378

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

    PubMed Central

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

    2012-01-01

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

  8. Evaluation of ultrasonography as a diagnostic tool in the management of head and neck facial space infections: A clinical study

    PubMed Central

    Shah, Ajaz; Ahmed, Irshad; Hassan, Shahid; Samoon, Amina; Ali, Babar

    2015-01-01

    Introduction: Superficial facial space infections represent a significant amount of the dental problems that present to hospital. Determining whether an odontogenic swelling is a cellulitis or abscess is difficult, but important as both may require different treatments. The use of an ultrasound may aid in differentiating cellulitis and abscess. This study was done to compare the accuracy of clinical examination alone versus ultrasonography (USG) in the diagnosis of cellulitis and abscess in symptomatic patients with a diagnosis of superficial facial space infection. Materials and Methods: Twenty patients (1870 years) diagnosed as superficial facial space infections by clinical and radiographic examinations were included in the study and patients with significant medical conditions were excluded. The provisional clinical diagnosis was made after a thorough history was taken and clinical examination was performed to determine if the swelling was a cellulitis or abscess. Swelling was then evaluated using the ultrasonic transducer which was placed over the swelling to aid the diagnosis which was again recorded. An incision and drainage procedure was performed after the administration of local anesthesia. The success of the ultrasound intervention versus clinical examination was based on whether frank exudation was detected during incision and drainage of such swellings. Results: The statistical analysis found that USG is a valuable diagnostic aid for detection of abscess or cellulitis in head and neck facial space infections. Interpretation and Conclusion: The findings of this prospective analysis indicate that there was statistical difference between clinical examination alone and USG in making the correct diagnosis. The sensitivity, specificity, positive predictive, negative predictive, and accuracy were not similar for all methods tested. From the results of this study, ultrasound is recommended as an adjunct to clinical examination in differentiating between

  9. 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…

  10. Late skin reaction to iodixanol (Visipaque): clinical manifestations, patch test study, and histopathological evaluation.

    PubMed

    Delgado-Jimenez, Yolanda; Perez-Gala, Silvia; Aragüés, Maximiliano; Sanchez-Perez, Javier; Garcia-Diez, Amaro

    2006-12-01

    Late reactions to iodinated contrast media are frequent. Cutaneous manifestations are the commonest, in which maculopapular exanthema, a type of cutaneous presentation, is widespread. Controversy exists about the utility of the skin test in the management of these reactions. The aim of this study is to analyse the clinical characteristics, the histopathological findings, and the results of the patch test in patients who developed a late skin reaction (LSR) to the nonionic, dimeric, iodinated contrast media Visipaque. We retrospectively reviewed the patients with LSR to Visipaque, seen in the Dermatology Department between 1999 and 2005. A total of 12 patients participated in this study (7 men and 5 women), ages ranging from 39 to 76 years (mean 56). 11 of the patients had significant medical history. All the patients developed a maculopapular exanthema between 2 hr and 3 days after the radiological examination, involving the trunk and proximal limbs, although some of the patients showed involvement of distal areas. The skin biopsy, performed in 6 patients, showed nonspecific findings consistent with drug reaction. In 3 patients, patch tests to Visipaque and iodixanol were positive. The most frequent manifestation of LSR to iodixanol is a maculopapular exanthema, involving the trunk and the limbs, although distal involvement can be seen. Histopathological findings are nonspecific and cannot be distinguished from other drug reaction. Patch tests have a limited value, and in cases where they were negative, reintroduction of the drug triggered a new LSR.

  11. 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

  12. 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

  13. 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

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2008-01-01

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

  17. 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

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

    PubMed Central

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

    2015-01-01

    Statement of Problem: The accuracy and reliability of the methods used for programming the semi-adjustable articulators determine the accuracy in occlusion. The current recommended average settings using the Hanau's formula commonly used by clinicians is questionable, and thus reassessment is needed. This study was carried out to evaluate and compare the lateral condylar guidance: (1) Using the Hanau's formula and the computerized jaw tracking device (Kinesiograph). (2) On the right and left sides using both these methods. Materials and Methods: A total of 20 completely edentulous patients (14 male and 6 females) within 40–60 years of age were selected. Jaw relation was recorded followed by face bow transfer. Extraoral Gothic arch tracing was recorded; three protrusive records were obtained and condylar guidance was calculated. Lateral condylar guidance was then calculated using Hanau's formula, followed by the computerized jaw tracking device. A comparative evaluation was done of the obtained values. The same investigator worked with each of the study participants for the purpose of standardization. Results: The lateral condylar guidance values obtained using the Hanau's formula ranged from 14 to 17° while those obtained using the computerized K7 jaw tracking device ranged from 8 to 40°. Bennett angle values, obtained using the jaw tracking device and Hanau's formula showed statistically significant differences (P < 0.05) using paired t-test (at 95% confidence interval). Bennett angle values of the right and left sides found using the Hanau's formula were almost similar. Difference in the Bennett angle values of the right and left sides were found using the jaw tracking device. However, this difference was not statistically significant (P > 0.05). Conclusion: Based on the results, dentist and dental technicians should consider reassessing the current recommended average settings and use of the Hanau's formula for programming the semi-adjustable articulators

  19. 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

  20. 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

  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)

  2. 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

  3. 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

  4. 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

  5. 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.

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

    PubMed

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

    2015-12-01

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

  7. 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

  8. A double blind, randomized, placebo controlled clinical study evaluates the early efficacy of aflapin in subjects with osteoarthritis of knee.

    PubMed

    Vishal, Amar A; Mishra, Artatrana; Raychaudhuri, Siba P

    2011-01-01

    Aflapin(®) is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin(®) and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin(®) in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin(®) or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA. PMID:22022214

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

    PubMed Central

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

    2016-01-01

    Abstract Rationale, aims and objectives Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real‐world evaluation. Method Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real‐world comprehensive evaluations in health care settings. Results The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub‐steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built‐in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. Conclusions This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale‐up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. PMID:26804339

  10. 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

  11. Evaluation of Clinical Outcomes after Abdominal Rectopexy and Delorme’s Procedure for Rectal Prolapse: A Prospective Study

    PubMed Central

    Makineni, Hemanth; Rai, B.K. Shivprasad

    2014-01-01

    Background: Complete rectal prolapse is characterized by protrusion of full thickness rectal wall through the anal orifice. Despite its rarity more than 100 surgical procedures have been described and there are no good evidence based recommendations for selection of a surgical procedure. This study was conducted to evaluate the clinical outcomes of commonly used procedures for rectal prolapse at our hospital. Materials and Methods: Twenty seven patients presenting with complete rectal prolapse between May 2011 to May 2013 were included in this prospective study. Patients underwent either Abdominal rectopexy or Delorme’s procedure after evaluation, based on clinical judgment of experienced surgeons. Patient characteristics, complications, post-operative length of hospitalization and clinical outcomes were assessed. Patients were followed up for a mean duration of 14 months. Results: Seventeen patients underwent Abdominal rectopexy (Posterior mesh rectopexy), ten patients underwent Delorme’s procedure. No postoperative mortalities or major complications were noted. Post operative morbidity (minor) was 17% in Abdominal rectopexy group and 10% in Delormes group 0%. Incontinence improved in all six patients (100%) in rectopexy group, four patients (80%) in Delorme’s procedure group. Two patients (11%) in rectopexy group reported increase in constipation post operatively. There was one recurrence in Delorme’s procedure group with no recurrences in Abdominal rectopexy group. Conclusion: The treatment of rectal prolapse should be individualized to achieve best results. Abdominal rectopexy can be safely applied in most of patients with minimal post operative increase in constipation and recurrence by using posterior mesh rectopexy technique. Delorme’s procedure can be performed with minimal morbidity and shorter hospital stay and good functional results with acceptable recurrence rate. Delorme’s can be considered as an alternative to rectopexy not only in

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

    PubMed

    Hsieh, Sung-Tsang; Chu, Nai-Shin

    2004-12-01

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

  13. 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

  14. 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

  15. Evaluation of dietetic product innovations: the relative role of preclinical and clinical studies.

    PubMed

    Makrides, Maria; Gibson, Robert A

    2010-01-01

    A variety of systems are used to establish efficacy of food ingredients. Immortal human cell lines have the advantage of rapid throughput and often have the ability to point to mechanisms of action. Transgenic and natural variants of animals (usually rats and mice) have proven to be extremely useful in elucidating effects in vivo, although extrapolation of results to humans has risks. Animal models are also useful in establishing safety and toxic levels of ingredients. Human trials have the most relevance to society. Types of evidence for efficacy rise from improved status level in subjects as a result of eating food (long-chain polyunsaturated fatty acid, levels in erythrocytes), change in surrogate markers as a result of eating food (plasma cholesterol or glutathione peroxidase activity), change in a physiological outcome (such as visual evoked potential acuity or heart rate variability) through to the highest level of evidence, a change in a clinical outcome (improved global development, reduction in infections) established in randomized controlled trials. Ultimately, there is a need for tests of pragmatic interventions that can easily be incorporated into usual dietary practices of the culture in which it is tested. PMID:20664222

  16. 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

  17. 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

  18. 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

  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. Clinical evaluation of functional dysphonia.

    PubMed

    Monday, L A

    1983-10-01

    Functional dysphonia is a voice impairment without any organic lesion of the phonating system. It may be classified into two categories: functional dysphonia itself where no lesions are found and functional laryngopathies where vocal cord lesions may be attributed to vocal abuse or misuse. The clinical evaluation of a dysphonic patient is performed in three steps: history taking, vocal evaluation, and examination. History taking helps the diagnosis and may be considered also as a therapeutic procedure. Vocal evaluation is oriented toward the voice itself and how it is produced. Then an ENT examination is performed with special attention to the larynx. In functional dysphonia, usually, everything looks normal but there may be signs of inflammation, hyperkinetism, hypokinetism, excessive laryngeal movements, etc. Functional laryngopathies include vocal nodules, laryngitis, polyps, and contact ulcer.

  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. [Bacteriological, pharmacokinetic and clinical evaluations of cefpirome sulfate in the pediatric field. Pediatric Study Group of Cefpirome].

    PubMed

    Fujii, R; Abe, T; Meguro, H; Tajima, T; Nakazawa, S; Sato, H; Hirama, Y; Narita, A; Matsumoto, K; Nakazawa, S

    1991-01-01

    A research group was organized with the purpose of making basic and clinical studies on cefpirome sulfate (HR810, CPR), a newly developed cephalosporin antibiotic, in the pediatric field. Through meetings a joint research was done involving 19 key institutions and their related facilities throughout Japan. The obtained results are summarized as follows. 1. Antibacterial Activities Minimum inhibitory concentrations (MICs) were determined against 71 Gram-positive and 110 Gram-negative bacteria in the present clinical trials. CPR showed antibacterial activities 2-16 times higher than those of ceftazidime (CAZ) against Staphylococcus aureus and other Gram-positive bacteria including MRSA. Against Gram-negative bacteria, CPR showed a somewhat broad range of distribution in MIC against Branhamella catarrhalis, while the antibiotic inhibited the growth of all the strains of Escherichia coli and Haemophilus influenzae at concentrations no more than 0.10 and 0.20 micrograms/ml, respectively. 2. Blood Concentrations and Urinary Excretion Rates The pharmacokinetics in pediatric patients was investigated with a dose of 20 mg/kg in most cases via one shot intravenous injection or 30- and 60-minute intravenous drip infusion. Mean blood concentrations of CPR at 15 minutes after one shot intravenous injection of 10, 20, and 40 mg/kg were 51.2, 70.5, and 123.5 micrograms/ml, with half-lives of 1.21, 1.39, and 1.53 hours, respectively. Urinary excretion rates in 6 hours were 63.6, 66.0 and 71.6%, respectively for the 3 dose levels. After 30- and 60-minute intravenous drip infusions at the same dose, the pharmacokinetic parameters observed were similar to those obtained with one shot injections. 3. Concentration in the Cerebrospinal Fluid CPR penetrated well into the cerebrospinal fluid in patients with purulent meningitis and levels of 1.85-24.2 micrograms/ml 45-60 minutes were achieved after intravenous injection at a dose of 40-80 mg/kg, the penetration rate of CPR was at an

  6. Evaluating ego defense mechanisms using clinical interviews: an empirical study of adolescent diabetic and psychiatric patients.

    PubMed

    Jacobson, A M; Beardslee, W; Hauser, S T; Noam, G G; Powers, S I; Houlihan, J; Rider, E

    1986-12-01

    Ego defense mechanisms were studied in three groups of early adolescents: diabetic patients, non-psychotic psychiatric patients, and healthy high school students. Defenses were assessed from ratings of open-ended, in-depth interviews. High levels of denial and low levels of asceticism were found in all three groups. Comparisons between groups indicated that psychiatric patients had a distinctive profile of defense usage, in comparison to adolescents from the other two groups. An independent measure of ego development was positively correlated with the defenses of altruism, intellectualization, and suppression, while it was negatively correlated with acting out, avoidance, denial, displacement, projection, and repression. The findings of substantial differences in defense usage between the psychiatric and non-psychiatric samples, and the size and directions of the correlations with ego development level, lend support to the validity of the defense codes.

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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

  12. 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

  13. A prospective clinical evaluation of electronically mixed polyvinyl siloxane impression materials: results from the prosthetic "SuperStudy"--a consumer evaluation.

    PubMed

    Kugel, G; Swift, E J; Sorensen, J A; Tucker, J H; Dunne, J T

    1999-01-01

    Polyvinyl siloxane (PVS) impression materials incorporating a polyether carbosilane wetting agent and mixed with an electronic mixing system (Pentamix) were clinically compared with traditionally delivered (i.e., automixed) PVS impression materials during routine use by 1,505 general and specialized dental practitioners evaluating more than 30,000 impressions. Each study participant selected 20 patients and used standard tooth-preparation procedures appropriate to the therapy required, supplied specific data on each case, and ultimately evaluated the marginal detail, fit, and success of the final restorations. The areas requiring evaluation upon completion of the final restorations were ranked between "excellent," "good," "poor," and "remake needed," among users of the PVS materials with the electronic mixing system. About 80% of the respondents rated the Pentamix system as easier to mix and deliver than the gun or hand-mixed systems and two thirds said it was faster to mix. The system also received high scores for hygienic delivery, ease of mixing, and clean-up.

  14. [Clinical evaluation of a hyperferritinemia].

    PubMed

    Sogni, Philippe; Buffet, Catherine

    2013-04-01

    A hyperferritinemia has to be interpreted in relation with age and sex. The clinical evaluation begins with the interpretation of transferrine saturation which has to be controlled with a second fasting blood test. In case of high transferrine saturation associated with hyperferritinemia, HFE testing has first to be realized since the first diagnosis suspected is a HFE hemochromatosis. In case of normal transferrine saturation associated with a hyperferritinemia, the more frequent diagnosis is a metabolic syndrome, an inflammatory syndrome, a syndrome of cellular lysis or an excessive alcohol consumption. In case of HFE hemochromatosis, phlebotomy prevents complications. The goal is to obtain and to maintain a normal-low ferritin level. In case of metabolic syndrome, phlebotomy could be useful in case of high hepatic iron concentration measured with MRI or in case of on-alcoholic steato-hepatitis.

  15. 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

  16. Clinical evaluation of bevantolol hydrochloride in patients with severe hypertension. The Cooperative Study Group on Bevantolol in Japan.

    PubMed

    Noshiro, T; Miura, Y; Yoshinaga, K; Iimura, O; Inagaki, Y; Saruta, T; Ishii, M; Yamazaki, N; Arakawa, K

    1995-04-01

    The clinical efficacy and safety of bevantolol hydrochloride, a newly developed beta-blocker, used in combination with other types of antihypertensive agents, were evaluated in patients with severe hypertension by multicenter open-label trials. A total of 28 patients were studied at 20 medical centers. Four patients (14.3%) were excluded for some reasons, and the remaining 24 patients (22 outpatients and 2 inpatients) were analyzed. Following the initiation of therapy, blood pressure decreased from 181 +/- 15 (SD)/114 +/- 3 mmHg to 170 +/- 17/102 +/- 8 mmHg (p < 0.01) on the 14th day of the therapy and gradually lowered further thereafter. At the end of the trial (8th week), blood pressure was stabilized at the level of 160 +/- 14/96 +/- 10 mmHg. The antihypertensive efficacy rated by the changes in mean blood pressure was 79.2% (19/24). Pulse rate decreased slightly but significantly from 75 +/- 10 beats/min to 70 +/- 7 (p < 0.05) on the 14th day of the therapy and stabilized at the similar level thereafter. As abnormal laboratory data were detected in 3 patients and 1 patient complained of a mild headache, the safety ratio was 83.3% (20/24 patients). When the usefulness was assessed in terms of antihypertensive efficacy and safety profiles, bevantolol hydrochloride was considered useful in 75.0% of the patients studied. In conclusion, bevantolol hydrochloride, used in combination with other classes of antihypertensive agents, appears to be an excellent drug for the management of patients with severe hypertension.

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

    PubMed Central

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

    2016-01-01

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

  18. Determining the clinically important difference in visual analog scale scores in abuse liability studies evaluating novel opioid formulations

    PubMed Central

    Eaton, Thomas A.; Comer, Sandra D.; Revicki, Dennis A.; van Inwegen, Richard G.; Stauffer, Joseph W.; Katz, Nathaniel P.

    2013-01-01

    Purpose This study determined how the magnitude of change in positive subjective responses predicts clinical outcome in a treatment setting. Specifically, we attempted to define what constitutes a clinically important difference (CID) in subjective responses. Methods A 100-mm visual analog scale (VAS) measured subjective ratings of drug “high,” calculated via an anchor-based method with published data from participants receiving sustained-release naltrexone (NTX) and heroin in a laboratory setting. The data were then compared to clinical outcomes in a treatment trial with sustained-release naltrexone. A distribution-based method subsequently analyzed data from participants who received ALO-01 (extended-release morphine with sequestered NTX) to predict its abuse liability. Results Differences in ratings of drug high of approximately 10 mm on a 100-mm line were clinically significant. By extrapolation, CIDs were also found between crushed or intact ALO-01 and immediate-release morphine sulfate (IRMS). No CIDs were found between intact and crushed ALO-01. Conclusions From laboratory and treatment trial data involving naltrexone, calculation of CIDs in subjective ratings of high is possible. Consequently, crushing/swallowing or injecting ALO-01 produces clinically significantly less drug high than oral or intravenous morphine alone, suggesting that ALO-01 has lower abuse liability by those routes than morphine formulations. PMID:21964915

  19. 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

  20. 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)

  1. Evaluation of clinical parameters to select high prevalence populations for periodontal disease: A cross-sectional study

    PubMed Central

    Harikishan, G.; Triveni, V. S. S.; Sai Sujay, G. S. Naga

    2015-01-01

    Epidemiological studies have shown strong evidence that periodontal disease does not affect all subjects in the same manner. Objective: There are subjects and sites with higher risk for disease progression. This study tested parameters to select “a priori” sites and subjects potentially at risk. Materials and Methods: The data from periodontal clinical examinations of 2273 subjects was used. The clinical loss of attachment was measured in 6 sites per tooth. Using computer software, the patients were distributed into 14 age groups, with intervals of 5 years, from 11 years to greater than 75 years of age. The measure of each site was compared with the average and the median values of the subject age group, with the results indicating site comparative severity (SCS). Three global parameters were calculated: parameter 1 (PI) - percentage of sites with clinical attachment loss > 4 mm; parameter 2 (P2) - percentage of sites with clinical attachment loss j> 7 mm; parameter 3 (P3) - percentage of sites with clinical attachment loss surpassing the median value for the age group by 100% or more. Results: There were 1466 (65%) females and 807 (35%) males. Most subjects had PI, P2 and P3 values less than 30%. Parameter 3 allowed a division of the sample similar to that of Parameters 1 and 2, with the advantage of analyzing the subject in relation to his/her age group. It was suggested that the methodology of SCS is useful for selecting a population with a high disease prevalence, and that cut-off lines between 10% and 20% would be appropriate for using parameter. PMID:26538931

  2. Evaluating the perceptual and pathophysiological consequences of auditory deprivation in early postnatal life: a comparison of basic and clinical studies.

    PubMed

    Whitton, Jonathon P; Polley, Daniel B

    2011-10-01

    Decades of clinical and basic research in visual system development have shown that degraded or imbalanced visual inputs can induce a long-lasting visual impairment called amblyopia. In the auditory domain, it is well established that inducing a conductive hearing loss (CHL) in young laboratory animals is associated with a panoply of central auditory system irregularities, ranging from cellular morphology to behavior. Human auditory deprivation, in the form of otitis media (OM), is tremendously common in young children, yet the evidence linking a history of OM to long-lasting auditory processing impairments has been equivocal for decades. Here, we review the apparent discrepancies in the clinical and basic auditory literature and provide a meta-analysis to show that the evidence for human amblyaudia, the auditory analog of amblyopia, is considerably more compelling than is generally believed. We argue that a major cause for this discrepancy is the fact that most clinical studies attempt to link central auditory deficits to a history of middle ear pathology, when the primary risk factor for brain-based developmental impairments such as amblyopia and amblyaudia is whether the afferent sensory signal is degraded during critical periods of brain development. Accordingly, clinical studies that target the subset of children with a history of OM that is also accompanied by elevated hearing thresholds consistently identify perceptual and physiological deficits that can endure for years after peripheral hearing is audiometrically normal, in keeping with the animal studies on CHL. These studies suggest that infants with OM severe enough to cause degraded afferent signal transmission (e.g., CHL) are particularly at risk to develop lasting central auditory impairments. We propose some practical guidelines to identify at-risk infants and test for the positive expression of amblyaudia in older children. PMID:21607783

  3. An open-label pilot study to evaluate the efficacy and tolerability of a silicone gel in the treatment of hypertrophic scars using clinical and ultrasound assessments.

    PubMed

    Lacarrubba, Francesco; Patania, Lara; Perrotta, Rosario; Stracuzzi, Giorgio; Nasca, Maria Rita; Micali, Giuseppe

    2008-01-01

    Silicone gel sheets and intralesional corticosteroids are effective treatments for hypertrophic scars according to evidence studies. The aim of this study was to evaluate, both clinically and by ultrasound, the efficacy and tolerability of a topical self-drying silicone gel containing polysiloxane and silicone dioxide applied twice daily in eight hypertrophic scars. After 6 months all lesions showed evident clinical and/or ultrasound improvement, with a mean scar thickness reduction of 37% (range 20-54%). Although controlled trials in larger series of patients are necessary, our results suggest that the self-drying silicone gel may represent a safe and effective treatment for hypertrophic scars.

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

    PubMed Central

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

    2016-01-01

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

  5. Evaluation of psychic change through the application of empirical and clinical techniques for a 2-year treatment: a single case study.

    PubMed

    Moreno, Clara M López; Schalayeff, Cristina; Acosta, Silvia R; Vernengo, Pía; Roussos, Andrés J; Lerner, Beatríz Dorfman

    2005-07-01

    Abstract The authors present results obtained by a combination of clinical and empirical methods used in the evaluation of psychic change involving a single case study carried out during 2 years of nonmanualized psychodynamic psychotherapy (Barber & Crits-Christoph, 1993 ; Barber, Foltz, DeRubeis, & Landis, 2002 ). A multidimensional definition of change that includes clinical (psychoanalytic) and empirical perspectives is provided. The authors used material from supervision sessions and clinical meetings to assess the psychodynamic diagnosis and evolution. The following empirical techniques and instruments were used: core conflictual relationship theme (Luborsky & Crits-Christoph, 1990), Symptom Checklist-90-Revised (Derogatis, 1983), and Differential Elements for a Psychodynamic Diagnostic (C. M. López Moreno et al., 1998 ). Several markers of psychic change along the therapeutic process were found. The instruments proved to be sensitive to the changes obtained during the psychotherapy. Used together, the instruments allowed an integrated evaluation of the patient's evolution during the treatment.

  6. 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

  7. A new approach to training back-propagation artificial neural networks: empirical evaluation on ten data sets from clinical studies.

    PubMed

    Ciampi, Antonio; Zhang, Fulin

    2002-05-15

    We present a new approach to training back-propagation artificial neural nets (BP-ANN) based on regularization and cross-validation and on initialization by a logistic regression (LR) model. The new approach is expected to produce a BP-ANN predictor at least as good as the LR-based one. We have applied the approach to ten data sets of biomedical interest and systematically compared BP-ANN and LR. In all data sets, taking deviance as criterion, the BP-ANN predictor outperforms the LR predictor used in the initialization, and in six cases the improvement is statistically significant. The other evaluation criteria used (C-index, MSE and error rate) yield variable results, but, on the whole, confirm that, in practical situations of clinical interest, proper training may significantly improve the predictive performance of a BP-ANN.

  8. 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.

  9. 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

  10. Reflective journaling for clinical judgment development and evaluation.

    PubMed

    Lasater, Kathie; Nielsen, Ann

    2009-01-01

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

  11. 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...

  12. 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

  13. 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.

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

    PubMed

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

    2015-12-01

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

  15. Method for evaluating performance of clinical pharmacists.

    PubMed

    Schumock, G T; Leister, K A; Edwards, D; Wareham, P S; Burkhart, V D

    1990-01-01

    A performance-evaluation process that satisfies Joint Commission on Accreditation of Healthcare Organizations criteria and state policies is described. A three-part, criteria-based, weighted performance-evaluation tool specific for clinical pharmacists was designed for use in two institutions affiliated with the University of Washington. The three parts are self-appraisal and goal setting, peer evaluation, and supervisory evaluation. Objective criteria within each section were weighted to reflect the relative importance of that characteristic to the job that the clinical pharmacist performs. The performance score for each criterion is multiplied by the weighted value to produce an outcome score. The peer evaluation and self-appraisal/goal-setting parts of the evaluation are completed before the formal performance-evaluation interview. The supervisory evaluation is completed during the interview. For this evaluation, supervisors use both the standard university employee performance evaluation form and a set of specific criteria applicable to the clinical pharmacists in these institutions. The first performance evaluations done under this new system were conducted in May 1989. Pharmacists believed that the new system was more objective and allowed more interchange between the manager and the pharmacist. The peer-evaluation part of the system was seen as extremely constructive. This three-part, criteria-based system for evaluation of the job performance of clinical pharmacists could easily be adopted by other pharmacy departments.

  16. 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

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

    PubMed Central

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

    2012-01-01

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

  18. [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

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

    PubMed Central

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

    2003-01-01

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

  20. 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

  1. Evaluation of toxicity: clinical issues.

    PubMed

    Vietti, T J

    1980-01-01

    Toxicity criteria used by three of the major cooperative groups are reviewed and discussed. The definition of acceptable toxicity will depend on the extent of disease and the availability of effective therapy. For some forms of toxicity there are adequate early warning signals; for other forms no satisfactory criteria yet exist. Until recently, no attempt had been made to systematically evaluate the quality of the patient's life during and after therapy. We are just now beginning to assess the long-term pathophysiologic changes that occur during and after multimodal therapy. The protocol must include information concerning agent toxicity, criteria for modification of therapy, and time intervals for documentation of toxicity. We must continue to develop therapeutic regimens which control the disease but interfere minimally with the quality of life.

  2. [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

  3. 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 ...

  4. A Clinical Evaluation System for Anesthesiology Residents.

    ERIC Educational Resources Information Center

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

    1988-01-01

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

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

    SciTech Connect

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

    1982-07-01

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

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

    PubMed Central

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

    2016-01-01

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

  7. 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

  8. 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

  9. 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. ...

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

    PubMed

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

    2012-12-17

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

  11. 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

  12. Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study

    PubMed Central

    Ambiye, Vijay R.; Dongre, Swati; Aptikar, Pradnya; Kulkarni, Madhura; Dongre, Atul

    2013-01-01

    Ashwagandha (Withania somnifera) has been described in traditional Indian Ayurvedic medicine as an aphrodisiac that can be used to treat male sexual dysfunction and infertility. This pilot study was conducted to evaluate the spermatogenic activity of Ashwagandha root extract in oligospermic patients. Forty-six male patients with oligospermia (sperm count < 20 million/mL semen) were enrolled and randomized either to treatment (n = 21) with a full-spectrum root extract of Ashwagandha (675 mg/d in three doses for 90 days) or to placebo (n = 25) in the same protocol. Semen parameters and serum hormone levels were estimated at the end of 90-day treatment. There was a 167% increase in sperm count (9.59 ± 4.37 × 106/mL to 25.61 ± 8.6 × 106/mL; P < 0.0001), 53% increase in semen volume (1.74 ± 0.58 mL to 2.76 ± 0.60 mL; P < 0.0001), and 57% increase in sperm motility (18.62 ± 6.11% to 29.19 ± 6.31%; P < 0.0001) on day 90 from baseline. The improvement in these parameters was minimal in the placebo-treated group. Furthermore, a significantly greater improvement and regulation were observed in serum hormone levels with the Ashwagandha treatment as compared to the placebo. The present study adds to the evidence on the therapeutic value of Ashwagandha (Withania somnifera), as attributed in Ayurveda for the treatment of oligospermia leading to infertility. PMID:24371462

  13. Clinical Evaluation of Predictive Data for Prospective Home Economics Teachers.

    ERIC Educational Resources Information Center

    Gilbert, Ardyce Lucile

    This investigation, part of a longitudinal study of homemaking teacher effectiveness, was designed to explore the usefulness of clinical judgments to predict teacher success. Clinical judgment is defined as involving the ability to make sound decisions after gathering and evaluating all the pertinent evidence, weighing possible alternatives in…

  14. 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

  15. A Double Blind, Randomized, Placebo Controlled Clinical Study Evaluates the Early Efficacy of Aflapin® in Subjects with Osteoarthritis of Knee

    PubMed Central

    Vishal, Amar A.; Mishra, Artatrana; Raychaudhuri, Siba P

    2011-01-01

    Aflapin® is a novel synergistic composition derived from Boswellia serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is more efficacious as an anti-inflammatory agent compared to the existing Boswellia products, 5-Loxin® and traditional 65% Boswellia extract. A 30-day, double-blind, randomized, placebo-controlled study was conducted to validate the efficacy of Aflapin® in the management of clinical symptoms of osteoarthritis (OA) of the knee (Clinical trial registration number: ISRCTN69643551). Sixty eligible OA subjects selected through screening were included in the study. The subjects received either 100 mg (n=30) of Aflapin® or placebo (n=30) daily for 30 days. Each subject was evaluated for pain and physical functions by using the standard tools (visual analog scale, Lequesne's Functional Index, and Western Ontario and McMaster Universities Osteoarthritis Index) at the baseline (day 0), and at days 5, 15 and 30. A series of biochemical tests in serum, urine and hematological parameters established the safety of Aflapin. The observations suggest that Aflapin conferred clinically and statistically significant improvements in pain scores and physical function scores in OA subjects. Aflapin provided significant improvements in pain score and functional ability in as early as 5 days of treatment. In conclusion, our observations suggest that Aflapin is a safe, fast acting and effective alternative intervention in the management of OA. PMID:22022214

  16. 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

  17. Clinical and radiological evaluation of zinc oxide-eugenol and Maisto's paste as obturating materials in infected primary teeth--nine months study.

    PubMed

    Reddy, V V; Fernandes

    1996-06-01

    The present study, performed in-vivo, included 30 infected primary teeth in 26 children in the age group of 3-8 years. The purpose of this study was to compare the efficacy of two obturating materials, zinc oxide-eugenol and Maisto's paste, in infected primary teeth. 30 teeth were divided into two groups of 15 teeth. Teeth in Group I were obturated using zinc oxide-eugenol and those in Group II were obturated using Maisto's paste. On clinical evaluation, teeth obturated with Maisto's paste showed 100% success. Five teeth that were overfilled with Maisto's paste showed complete resorption of excess material within 3 months while the two teeth overfilled with zinc oxide-eugenol showed incomplete resorption of the excess material even after 9 months. Zinc oxide-eugenol treated cases showed only 26.7% bone regeneration while in case of Maisto's paste, it was 93%. Complete healing of the inter-radicular pathology was seen with Maisto's paste. However, the pathology was present in 40% of the zinc oxide-eugenol treated teeth even after 9 months. Maisto's paste was thus seen to be superior to zinc oxide-eugenol both in clinical as well as radiological evaluation, done over a period of 9 months in relation to bone regeneration, healing of inter-radicular pathology and resorption of excess material.

  18. 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

  19. 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

  20. A national evaluation of specialists' clinics in primary care settings.

    PubMed Central

    Bowling, A; Bond, M

    2001-01-01

    BACKGROUND: Encouraged by the increased purchasing power of general practitioners (GPs), specialist-run clinics in general practice and community health care settings (known as specialist outreach clinics) have increased rapidly across England. The activities of local commissioning schemes within primary care groups are likely to accelerate this trend. AIM: To evaluate the costs, processes, and benefits of specialists' outreach clinics held in GPs' surgeries, compared with hospital outpatient clinics. DESIGN OF STUDY: A case-referent (comparative) study comparing the characteristics of outreach clinics (cases) with matched outpatient control clinics. SETTING: Thirty-eight outreach clinics, compared with 38 matched outpatient clinics as controls, covering 14 hospital trust areas across England. METHOD: Self-administered questionnaires were given to patients in both clinic settings. These covered processes, satisfaction, personal costs, and health status, with postal follow-up at six months to assess health outcomes. Self-administered questionnaires were also given to the specialists and GPs whose clinics were included in the study (individual patient clinical sheet and an attitude questionnaire), practice managers, and trust accountants (process and costs questionnaire). Evaluation of the costs, processes, and benefits of specialist outreach clinics versus hospital outpatient clinics was carried out by comparing questionnaire responses. RESULTS: In comparison with outpatients, outreach clinic patients spent less time on the waiting lists for appointments to see the specialist, they had shorter waiting times in clinics, fewer follow-up appointments, and were more likely to be completely discharged after the sampled attendance. Outreach patients were more satisfied than outpatients with the range of clinic process items asked about. Most doctors felt that the outreach clinic was 'worthwhile'. While patients' personal costs were lower in outreach than in outpatients

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

    PubMed

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

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial. PMID:24480160

  2. 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

  3. 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

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

    PubMed

    Jørgensen, Bo; Karlsmark, Tonny; Vogensen, Hanne; Haase, Lone; Lundquist, Rasmus

    2011-12-01

    This prospective, uncontrolled pilot study evaluated the safety and clinical performance of Leucopatch an additive-free, autologous platelet-rich fibrin in the treatment of recalcitrant chronic wounds. Fifteen patients, with 16 lower extremity chronic wounds of varying etiologies were treated weekly with Leucopatch, prepared at the point of care from a donation of the patients' blood, for 6 weeks, or until healing was complete. The wounds had been present for 2 to 108 months (median 24 months) and ranged in size from 0.4 to 15.7 cm(2) (median 2.3 cm(2)) and had not responded to previous treatments. Of the 13 wounds (12 patients) included in the per-protocol efficacy analysis, 4 healed completely (31%). Mean wound area decreased significantly by 65% (95% confidence interval = 45.6% to 83.8%) resulting in a median wound size of 0.9 cm(2) (range = 0-9.6cm(2)). There were no serious adverse events. Two adverse events, one of noncompliance and one infection, were observed; neither was considered to be related to treatment. The results indicate that Leucopatch is easy to prepare and apply in the clinic, is safe, and may be a clinically effective treatment of recalcitrant chronic wounds.

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

    PubMed Central

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

    2014-01-01

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

  6. Benign prostatic hyperplasia: clinical manifestations and evaluation.

    PubMed

    Santos Dias, José

    2012-12-01

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

  7. 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.

  8. 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

  9. 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

  10. Clinical Evaluation of Cervicogenic Headache: A Clinical Perspective

    PubMed Central

    Hall, Toby; Briffa, Kathy; Hopper, Diana

    2008-01-01

    Headache is a common complaint that affects the majority of the population at some point in their lives. The underlying pathological bases for headache symptoms are many, diverse, and often difficult to distinguish. Classification of headache is principally based on the evaluation of headache symptoms as well as clinical testing. Although manual therapy has been advocated to treat a variety of different forms of headache, the current evidence only supports treatment for cervicogenic headache (CGH). This form of headache can be identified from migraine and other headache forms by a comprehensive musculoskeletal examination. Examination and subsequent diagnosis is essential not only to identify patients with headache where manual therapy is appropriate but also to form a basis for selection of the most appropriate treatment for the identified condition. The purpose of this paper is to outline, in clinical terms, the classification of headache, so that the clinician can readily identify those patients with headache suited to manual therapy. PMID:19119390

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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.

  16. Adsorption of 99mTc-Sestamibi onto Plastic Syringes: Evaluation of Factors Affecting the Degree of Adsorption and Their Impact on Clinical Studies*

    PubMed Central

    Swanson, Tiffinee N.; Troung, Duong T.; Paulsen, Andrew; Hruska, Carrie B.; O’Connor, Michael K.

    2014-01-01

    The purpose of this study was to document the extent of adhesion of 99mTc-sestamibi to syringes in patient procedures, determine factors that influence the degree of adhesion, and evaluate alternatives to our current practice that would either result in a more reproducible degree of adhesion or, ideally, eliminate adhesion. Methods The extent of adhesion was documented in 216 patient procedures and evaluated in detail in an additional 73 patient procedures. We evaluated the nature of the adhesion and its possible causes, including the location of adhesion in injection sets, the effect of syringe type, and the effect of prerinsing of syringes with various solutions of nonradiolabeled sestamibi and 99mTc-sestamibi. The extent of adhesion was reevaluated in 50 procedures performed using the syringe type that demonstrated the lowest adhesion rate. Results The degree of adhesion of 99mTc-sestamibi to the injection set was found to be 20.1% ± 8.0%, with a range (10th–90th percentiles) of 9%–31%. The primary cause of adhesion appeared to be the lubricant used inside the syringe barrel. Evaluation of 6 different syringe types identified a brand with a lower adhesion rate. Reevaluation in patient procedures using this brand showed a 5.2% ± 2.5% degree of adhesion, with a range (10th–90th percentiles) of 2.5%–7.7%. Conclusion Selection of the appropriate type of syringe can significantly reduce the magnitude and variability of residual 99mTc-sestamibi activity. With more reproducible residual activities, we have been able to achieve an approximately 20% reduction in the dispensed dose of 99mTc-sestamibi used in clinical procedures and a more consistent injected dose with less interpatient variation. The frequent changes in syringe design by manufacturers require that a quality control program for monitoring of residual activity be incorporated into clinical practice. This program has allowed us to maintain image quality and achieve more consistent injected patient

  17. Evaluating clinical dermatology practice in medical undergraduates.

    PubMed

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

    2014-06-01

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

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

    PubMed

    García Villar, C

    2015-11-01

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

  19. [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

  20. [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

  1. Clinical evaluation of seven anticalculus dentifrice formulations.

    PubMed

    Scruggs, R R; Stewart, P W; Samuels, M S; Stamm, J W

    1991-01-01

    One hundred ninety-two subjects completed a clinical trial to determine the effects of seven dentifrice formulations on calculus inhibition. The double-blind study involved a ten-day control phase and a ten-day experimental phase. For the control phase, subjects were evaluated for calculus present, received a prophylaxis and had pre-weighed mylar strips attached to the lingual surfaces of the mandibular incisors to harvest mineral deposits. Subjects were then assigned the placebo dentifrice for unsupervised twice-daily use and were required to report once a day for a supervised mouthrinse using a 1:3 dilution of the dentrifice. The experimental phase was identical except that subjects were allocated the experimental dentifices using a stratified random assignment based on age, gender and the initial presence of calculus. Simple linear regression analyses of the dry and ash log weights obtained from the strips were performed. The results showed no statistically significant differences among the test products; however, two formulations containing zinc citrate showed some calculus inhibition-potential suggesting that further research and development of such products may be warranted.

  2. Clinical dilemmas in evaluating the short child.

    PubMed

    Garganta, Melissa D; Bremer, Andrew A

    2014-08-01

    Concerns about a child's growth are one of the most common topics parents voice during general pediatric office visits and are a leading cause for referral to a pediatric endocrinologist. There are a variety of conditions that lead to short stature in children; however, in the absence of true pathology, idiopathic short stature and constitutional delay are the most frequent causes. This article reviews the general approach to evaluating the short child and clinical signs that should prompt further evaluation and referral. We also address the unique psychological issues that these children face and approaches to counseling families with a child with idiopathic short stature.

  3. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-18

    ... guidance for industry entitled ``Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies.'' The draft guidance is intended to assist the pharmaceutical industry and other investigators... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Clinical...

  4. 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

  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. Clinical Evaluation of Kshara sutra Therapy in the management of Bhagandara( Fistula- in-Ano)- A prospective study

    PubMed Central

    Panigrahi, Hemanta Kumar; Rani, Rakesh; Padhi, M.M.; Lavekar, G.S.

    2009-01-01

    Study design: A prospective study of 50 patients suffering from Bhagandara(Fistula in Ano) (age ranging from 18-54years) treated by Kshara sutra therapy Place: Kshara sutra unit, Central research Unit, Punjabi bagh, New Delhi Duration: January 2007 to July 2008. Objectives: To determine the incidence of low or high anal fistula, recurrence rate following Kshara sutra therapy and effect of Ksharasutra therapy on the Bhagandara. Material and methods: The fifty patients (50) were selected randomly in the Out Patient Department. Study Design: Uncontrolled open level Study. Results: Patients were followed to see the incidence of recurrence, effect of Kshara Sutra Therapy on incontinence. Overall recurrence rate was only 5.88 %. Minor incontinence was observed only following Kshara sutra Therapy for high variety for which no treatment was given. No such complication occurred in low variety. Conclusion: Bhagandara (Fistula in Ano) can be treated by Kshara Sutra Therapy with minimal loss of sphincter muscle and low reoccurrence rate. PMID:22557318

  7. 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.

  8. 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

  9. Clinical and scanning electron microscopy evaluation of the Er,Cr:YSGG laser therapy for treating dentine hypersensitivity: short-term, randomised, controlled study.

    PubMed

    Yilmaz, H G; Bayindir, H

    2014-05-01

    Er,Cr:YSGG laser is a rising treatment option for dentine hypersensitivity (DH). However, there is no data available concerning the scanning electron microscope (SEM) evaluation of the clinical application of Er,Cr:YSGG laser in the treatment of DH. The aim of this study was to evaluate and compare the desensitising and tubule occlusion effects of Er,Cr:YSGG laser with different power settings. Twenty patients (60 teeth) participated in this study. For each patient, teeth were randomised to 3 groups. In groups 1 and 2, patients were treated with Er,Cr:YSGG laser at 0.25 and 0.5 W, respectively. In control group, same laser was applied without laser emission. DH was assessed for all groups with a visual analogue scale (VAS). When compared with the baseline data and control group, in both active treatment groups laser irradiation provided a desensitising effect immediately after treatment (P < 0.001). In group 2, VAS scores were significantly lower than group 1. The tubule diameters in the both laser groups were significantly smaller than the control group (P < 0.01). When group 1 compared with group 2, group 2 showed significantly smaller tubule diameters (P < 0.001). Both 0.25 and 0.5 W laser irradiation were effective for the treatment of DH; however, 0.5 W laser irradiation showed best results for the decrease in VAS scores. The SEM findings of the reduction in number/patency of dentine tubules seem to be related to the clinical findings, which were associated with improvement in treatment efficacy.

  10. Clinical and scanning electron microscopy evaluation of the Er,Cr:YSGG laser therapy for treating dentine hypersensitivity: short-term, randomised, controlled study.

    PubMed

    Yilmaz, H G; Bayindir, H

    2014-05-01

    Er,Cr:YSGG laser is a rising treatment option for dentine hypersensitivity (DH). However, there is no data available concerning the scanning electron microscope (SEM) evaluation of the clinical application of Er,Cr:YSGG laser in the treatment of DH. The aim of this study was to evaluate and compare the desensitising and tubule occlusion effects of Er,Cr:YSGG laser with different power settings. Twenty patients (60 teeth) participated in this study. For each patient, teeth were randomised to 3 groups. In groups 1 and 2, patients were treated with Er,Cr:YSGG laser at 0.25 and 0.5 W, respectively. In control group, same laser was applied without laser emission. DH was assessed for all groups with a visual analogue scale (VAS). When compared with the baseline data and control group, in both active treatment groups laser irradiation provided a desensitising effect immediately after treatment (P < 0.001). In group 2, VAS scores were significantly lower than group 1. The tubule diameters in the both laser groups were significantly smaller than the control group (P < 0.01). When group 1 compared with group 2, group 2 showed significantly smaller tubule diameters (P < 0.001). Both 0.25 and 0.5 W laser irradiation were effective for the treatment of DH; however, 0.5 W laser irradiation showed best results for the decrease in VAS scores. The SEM findings of the reduction in number/patency of dentine tubules seem to be related to the clinical findings, which were associated with improvement in treatment efficacy. PMID:24602082

  11. Evaluation of fracture topography and bone quality in periprosthetic femoral fractures: A preliminary radiographic study of consecutive clinical data.

    PubMed

    Leonidou, Andreas; Moazen, Mehran; Skrzypiec, Daniel M; Graham, Simon M; Pagkalos, Joseph; Tsiridis, Eleftherios

    2013-12-01

    The unique configuration of periprosthetic femoral fractures (PFFs) is a major determinant of the subsequent management. The aim of this preliminary study was to investigate potential relationships between fracture angle (FA), fracture level (FL) and bone quality of Vancouver type B PFF. The FA, FL and the canal thickness ratio (CTR) were quantified for 27 patient X-rays. The CTR is an indicator of the underlying bone quality. Relationships between these factors were studied for the whole X-ray set, for a subgroup involving fracture above the tip of the stem and for subgroups with stable and unstable implants. When considering all cases, no significant correlation was found between the FA and any other measurement. Considering only cases with unstable implants, a statistically significant correlation was found between the FA and the FL (R(2)=0.489, p=0.002). No correlation was found between FA and any other measurement for stable implants suggesting that FA could be considered as an independent factor when classifying B1 fractures. Considering all cases, a weak correlation was found between CTR and FL (R(2)=0.152, p=0.044) suggesting that fractures below the tip of the stem may indicate a lower bone quality. This preliminary study suggests that the effect of FA on the optimal management of Vancouver type B1 fractures could be considered, independent of the quality of the bone or fracture position. Furthermore, fractures around or below the tip of the stem may suggest a poor bone quality. Larger number of patients is required to confirm these initial findings.

  12. [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.

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

    PubMed Central

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

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  15. [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

  16. Evaluation of melanotan-II, a superpotent cyclic melanotropic peptide in a pilot phase-I clinical study.

    PubMed

    Dorr, R T; Lines, R; Levine, N; Brooks, C; Xiang, L; Hruby, V J; Hadley, M E

    1996-01-01

    A pilot phase I study was conducted with a cyclic heptapeptide analog of alpha-melanocyte stimulating hormone (alpha-MSH). The lactam-bridged molecule, called Melanotan-II (MT-II), has the structure Ac-Nle4-Asp5-His6-D-Phe7-Arg8-Trp9-Lys10 alpha-MSH4-10-NH2 (MT-II) and has superpotent melanotropic activity in vitro. A single-blind, alternating day (saline or MT-II), placebo-controlled trial was conducted in 3 normal male volunteers at the starting dose of 0.01 mg/kg of MT-II. Subcutaneous injections of MT-II or saline were given daily (Monday-Friday) for 2 consecutive weeks. Two subjects were escalated by 0.005 mg/kg increments to 0.03 mg/kg and one to 0.025 mg/kg. The 0.03 mg/kg dose produced Grade II somnolence and fatigue in one of two subjects (WHO standards). Mild nausea, not requiring antiemetic treatment, was reported at most MT-II dose levels. A stretching and yawning complex appeared to correlate with the onset of spontaneous, penile erections which were intermittently experienced for 1-5 hours after MT-II dosing, depending on the MT-II dose. Two subjects had increased pigmentation in the face, upper body and buttock, as measured by quantitative reflectance and by visual perception 1 week after MT-II dosing ended. These results demonstrate that MT-II has tanning activity in humans given only 5 low doses every other day by subcutaneous injection. The recommended single MT-II dose for future Phase I studies is 0.025 mg/kg/day.

  17. Evaluation of clinical chemistry analytes from a single mouse using diluted plasma: effective way to reduce the number of animals in toxicity studies.

    PubMed

    Goyal, Vinod Kumar; Pandey, Santosh Kumar; Kakade, Somesh; Nirogi, Ramakrishna

    2016-10-01

    Clinical chemistry is an essential analytical tool in many areas of research, drug assessment and development, and in the evaluation of general health. A certain amount of blood is required to evaluate all blood analytes. Experiments where mice are used, it is difficult to measure all analytes due to the small amount of blood that can be obtained from a single animal. To overcome this problem, separate cohorts of animals are used in toxicity studies for hematology and biochemistry analysis. This requires the use of extra animals and additional resources. Hence interpretation of results derived from using these different animals can be unreliable. This study was undertaken to explore the possibility of using diluted plasma for measuring various biochemistry analytes. Plasma from mice was diluted to 3, 5 and 10-fold with Water for Injection, and various biochemistry analytes were analyzed using an automated analyzer. Results of diluted and undiluted plasma from the same mouse were compared. Most of the analytes from the diluted plasma were found to be well within the ranges of the undiluted plasma except for sodium, potassium and chloride. Diluting plasma to analyze some analytes also freed up undiluted plasma for analyzing electrolytes. In conclusion, in order to obtain reliable and interpretable data from a single mouse it is worthwhile considering diluting the plasma, which should reduce the number of animals used in an experiment.

  18. 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

  19. 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

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

    PubMed

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

    2014-11-15

    Canine heartworm disease caused by Dirofilaria immitis is considered a pulmonary disease, which leads to pulmonary hypertension, and in the late stage, may induce right cardiac insufficiency. Adult worms are localized in the pulmonary arteries, which undergo endothelial damage (proliferative endoarteritis), the severity of which depends on the duration of infection and the worm burden. C-reactive protein (CRP) is a major canine acute-phase protein that rapidly increases in a wide range of inflammatory conditions and rapidly decreases when inflammation resolves. CRP is therefore considered a sensitive but nonspecific marker of inflammation. Pulmonary arterial damage in canine heartworm may induce an increase in CRP concentrations similar to what occurs in humans with endoarteritis. The aim of the present study was to investigate whether CRP may be a diagnostic and/or prognostic marker in canine heartworm, whether it may be used for staging and monitoring canine heartworm, and whether its concentration depends on worm burden or on pulmonary arterial damage. Serum CRP concentrations were determined in 57 dogs with heartworm disease, 47 of which were grouped according to parasite burden (low: n=11; high: n=10) or on severity of pulmonary hypertension (mild: n=16; severe: n=10). An additional 23 heartworm-free cardiopathic dogs were grouped on the absence of pulmonary hypertension (n=8), presence of dilated cardiomyopathy (DCM) (n=6), or presence of cardiomyopathy and pulmonary hypertension (n=3) due to previous heartworm disease that had been treated (n=6). Twenty control dogs also were sampled for CRP concentrations. Results show that CRP was significantly increased (p<0.001) in dogs with heartworm or cardiomyopathy compared with concentrations in controls. In the heartworm group, CRP was significantly increased (p<0.001) in dogs with mild or severe pulmonary hypertension but not in dogs with low or high parasite burden without pulmonary hypertension. Heartworm

  1. Longitudinal clinical evaluation of post systems: a literature review.

    PubMed

    Soares, Carlos José; Valdivia, Andréa Dolores Correia Miranda; da Silva, Gisele Rodrigues; Santana, Fernanda Ribeiro; Menezes, Murilo de Souza

    2012-01-01

    In this survey, retrospective and prospective clinical studies dealing with cast-post-and core and fiber posts were reviewed regarding the rate of survival of restorations and the most prevalent failures. Electronic searches of the literature were performed in MEDLINE by crossing the key words: "Fiber post and clinical study", "Fiber post and clinical evaluation", "Cast post-and-core and clinical study", and "Root post and retrospective survival study". The cut-off dates were December 1990 through the end of December 2010. Review of literature showed that several interrelated biological, mechanical, and aesthetic factors are involved in the survival rate of restorative procedures in endodontically treated teeth, and post selection should fulfill and optimize these factors. Data based on long-term clinical studies are essential for the general practitioner when making clinical decisions. An adequate selection of teeth and post system must be made, and a minimal amount of existing tooth substance should be removed. A ferrule must be present for safe indication of the fiber posts. Fiber glass posts have demonstrated good survival in clinical studies, with similar performance to cast-post-and cores. Metallic posts have good clinical survival, but the associated failures are mostly irreversible, unlike what happens with the glass fiber posts.

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

    PubMed

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

    2014-11-01

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

  3. 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

  4. Clinical study of ectopic pregnancy.

    PubMed

    Chhabra, S; Aher, K; Jaiswal, M

    1992-01-01

    Ectopic pregnancy remains a leading cause of maternal mortality and accounts for a sizeable proportion of infertility and ectopic recurrence. The possibility that a woman is experiencing an ectopic pregnancy must be considered when evaluating a woman, especially a sterilized woman, who has a possible pregnancy, amenorrhea, abdominal pain, or abnormal bleeding; studies have found that one in six pregnancies occurring after tubal sterilization are ectopic. The authors present a clinical study of 82 cases of ectopic pregnancy admitted to the department of Obstetrics and Gynecology of Mahatma Gandhi Institute of Medical Sciences, Sevagram. Cases of ectopic pregnancy represent 0.99% of total obstetric admissions, of whom 69.51% were diagnosed as such on admission. 40.24% of the women were older than 30 years, while 34.14% were elderly beyond third parity. 70.73% of the women presented before missing their second period. Patients presented with multiple complaints, but the most common was abdominal pain reported by 61.70%. 78.04% were admitted with an acute abdomen, but shock was present in only 7.14% of cases. The main surgical treatment modality was salpingectomy among 59.75%. There was no maternal mortality through postoperative morbidity in the form of paralytic ileus, although fever did occur in some women.

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

    PubMed Central

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

    2016-01-01

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

  6. 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

  7. 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

  8. 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

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

    PubMed Central

    Mohan, Ranjana; Agrawal, Sudhanshu; Gundappa, Mohan

    2013-01-01

    Aim: A randomized controlled clinical study was undertaken to evaluate the effectiveness of scaling and root planing (SRP) by using Magnifying Loupes (ML) and dental operating microscope (DOM). Materials and Methods: A total of 90 human teeth scheduled for extraction from 18 patients aged between 25 and 65 years suffering from generalized chronic severe periodontitis were randomly assigned to three treatment groups. Group 1 consisted SRP performed without using magnification (unaided), Group 2-SRP with ML and Group 3-SRP with DOM. Following extractions, samples were prepared for (i) evaluation of surface topography by atomic force microscopy, (ii) presence of smear layer, debris by scanning electron microscopy (iii) elemental analysis by energy dispersive X-ray analysis. Data was subjected to statistical analysis using analysis of variance, post-hoc (Tukey-HSD) and Chi-square test. Results: Statistically significant (P < 0.001) difference was found among the different treatment groups. Group 3 was the best while Group 1 was the least effective technique for SRP. Order of efficacy in terms of the surface was found to be - Palatal < Lingual < Distal ≃ Mesial < Buccal. Efficiency in mandibular to maxillary teeth was found to be significant (P < 0.05), also anterior to posterior teeth (P < 0.05). Conclusion: Magnification tools significantly enhance the efficacy of supragingival and subgingival SRP. PMID:24124292

  10. 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

  11. 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.

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

    PubMed Central

    Raut, Chetan Purushottam; Sethi, Kunal S.

    2016-01-01

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

  13. [Economic evaluation studies in health].

    PubMed

    Rovira-Forns, Joan; Antoñanzas-Villar, Fernando

    2005-12-01

    Clinical journals often publish economic evaluation studies of health technologies and programs. To improve the peer review process and, hence, the quality and validity of published studies, the British Medical Journal (BMJ) established publication guidelines for the publication of economic evaluations aimed at authors, reviewers and editors. The present article analyzes the opportunity of adopting the BMJ's or similar guidelines by Medicina Clínica and the probable effectiveness of this measure. The article concludes that although this initiative would probably improve the review process and the quality of the papers published, it might be worthwhile to review, up-date and adapt the BMJ guidelines to the Spanish context by means of a consensus-forming process. Finally, this article discusses the limitations of the peer review process in improving the quality and validity of economic evaluations and suggests some complementary measures, drawing on lessons and experiences from the field of clinical research.

  14. Evaluation of clinical thermometers for accuracy and reliability.

    PubMed

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

    2001-01-01

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

  15. 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.

  16. Clinical evaluation of vein contrast enhancement

    NASA Astrophysics Data System (ADS)

    Lovhoiden, Gunnar; Deshmukh, Harshal; Zeman, Herbert D.

    2002-05-01

    A clinical study is underway to compare an experimental infrared (IR) device, OnTarget OnTarget at LeBonheur Children's Medical Center, Methodist Healthcare, in Memphis, TN, while the adult study site is the clinical research center at Bowld Hospital, also in Memphis, TN. Early results on 35 pediatric and 25 adult subjects indicate that OnTarget years' experience in accessing veins in pediatric subjects, and that it could be very helpful to a phlebotomist with limited experience when accessing veins in both adult and pediatric subjects. The study uses monitor based OnTarget area of the patients anatomy enlarged and contrast enhanced on a LCD monitor. The phlebotomist can then compare the OnTarget or feel when examining a subject.

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

    PubMed

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

    2013-01-01

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

  18. 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

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

    PubMed

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

    2013-01-01

    The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo. PMID:23745226

  20. Critical Evaluation of Oncology Clinical Practice Guidelines

    PubMed Central

    Reames, Bradley N.; Krell, Robert W.; Ponto, Sarah N.; Wong, Sandra L.

    2013-01-01

    Purpose Significant concerns exist regarding the content and reliability of oncology clinical practice guidelines (CPGs). The Institute of Medicine (IOM) report “Clinical Practice Guidelines We Can Trust” established standards for developing trustworthy CPGs. By using these standards as a benchmark, we sought to evaluate recent oncology guidelines. Methods CPGs and consensus statements addressing the screening, evaluation, or management of the four leading causes of cancer-related mortality in the United States (lung, breast, prostate, and colorectal cancers) published between January 2005 and December 2010 were identified. A standardized scoring system based on the eight IOM standards was used to critically evaluate the methodology, content, and disclosure policies of CPGs. All CPGs were given two scores; points were awarded for eight standards and 20 subcriteria. Results No CPG fully met all the IOM standards. The average overall scores were 2.75 of 8 possible standards and 8.24 of 20 possible subcriteria. Less than half the CPGs were based on a systematic review. Only half the CPG panels addressed conflicts of interest. Most did not comply with standards for inclusion of patient and public involvement in the development or review process, nor did they specify their process for updating. CPGs were most consistent with IOM standards for transparency, articulation of recommendations, and use of external review. Conclusion The vast majority of oncology CPGs fail to meet the IOM standards for trustworthy guidelines. On the basis of these results, there is still much to be done to make guidelines as methodologically sound and evidence-based as possible. PMID:23752105

  1. 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.

  2. 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

  3. Trained clinical nurse specialists proficiently obtain bone marrow aspirates and trephine biopsies in a nearly painless procedure--a prospective evaluation study.

    PubMed

    Naegele, M; Leppla, L; Kiote-Schmidt, C; Ihorst, G; Rebafka, A; Koller, A; May, A M; Hasemann, M; Duyster, J; Wäsch, R; Engelhardt, M

    2015-09-01

    Patients often experience bone marrow examinations (BMEs) as frightening and painful. Varying operators and uncertainty about who will perform the BME worsen their anxiety. In our study, clinical nurse specialists (CNSs) were trained to perform BMEs to ensure continuity and to test the feasibility, patient satisfaction, and biopsy quality. This exploratory evaluation assessed 574 BMEs at our tertiary center between January 2012 and February 2013, 398 BMEs performed by CNS and 176 by physicians. Our aims were to determine whether BMEs by CNS yield results similar to those of physicians, analyzing (1) patient satisfaction with the BME (a) consent and (b) performance, (2) induced pain, and (3) quality of aspirates and length of trephine biopsies. When performed by CNS, 100 % of the patients were satisfied with the consent procedure and 99 % with the BME performance (physicians 99 and 91 %, respectively). The median pain score was low when both CNS and physicians performed the BME, with no or only mild pain in 92 and 76 % of patients, respectively. Bone marrow (BM) aspirates by CNS and physicians were assessed as technically evaluable in ~70 %; moreover, the median length of trephine biopsies was similar when performed by CNS or physicians with 12 and 13 mm, respectively. In conclusion, BMEs conducted by motivated CNS and within a structured training program are feasible and yield equal outcomes compared to physicians. The use of adequate pain management during BMEs by trained and experienced operators results in an extremely rare use of sedatives, low pain scores, and high patient satisfaction.

  4. Case study of an inter-professional and inter-organisational programme to adapt, implement and evaluate clinical guidelines in secondary care.

    PubMed

    Hall, L; Eccles, M

    2000-01-01

    This paper describes the implementation of a clinical guideline across three acute Trusts. A Clinical Effectiveness Steering Group identified prevention of venous thromboembolism as a health priority. A local guideline development group adapted the recommendations of an existing review and produced a local guideline. Then, a multidisciplinary implementation group developed the practical aspects of implementing guidelines into routine daily practice. They identified appropriate staff to carry out risk assessment and to administer appropriate prophylaxis, as necessary. They also produced a "guideline pack" containing a training resource manual and implementation aids. Following this a multiple strategy implementation programme was used to introduce the guidelines, and an evaluation was carried out eight to ten months after the introduction of the guidelines. The evaluation identified a number of areas for improving current practice. Guideline implementation is a complex, time-consuming process.

  5. Evaluation of clinical efficacy and safety of once daily topical administration of 1% oxiconazole cream and lotion in dermatophytosis : an open label, non comparative multicentre study.

    PubMed

    Jerajani, H R; Amladi, S T; Bongale, R; Adepu, V; Tendolkar, U M; Sentamilselvi, G; Janaki, V R; Janaki, C; Vidhya, S; Marfatia, Y S; Patel, K; Sharma, N; Cooverji, N D

    2000-01-01

    The clinical efficacy and safety of once daily topical administration of 1% oxiconazole cream and lotion was assessed in an open label, non comparative trial in tinea cruris, tinea corporis and tinea pedis patients. In treated patients, severity scores of erythema, pruritus, scaling, vesicles, papules and burning showed a progressive fall over a period of 4 weeks at all the study centres. With lotion, mean percentage improvement of symptoms varied from 35% (week 1) to 87.6 - 98.7% (week 4). With cream, it varied from 35% (week 1) to 82.5 - 99.5% (week 4). Overall global evaluation response showed clear, excellent and good response in 60%, 21% and 17% of the patients treated with lotion respectively. With cream, excellent and good response was observed in 71%, 10% and 16% of the patients respectively. In T. pedis patients, clear, excellent and good response was observed in 4/8, 2/8 and 1/8 patients respectively with lotion. Cream showed clear (8/15), excellent (4/15) and good (1/15) in these patients. None of the patients out of 178 enrolled, reported any side effect during the trial.

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

    PubMed

    Smith, Lynette S; Branstetter, M Laurie

    2016-09-01

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

  7. 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

  8. 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.

  9. [Treatment of hemifacial spasm with type A botulinum toxin (AGN 191622): a dose finding study and the evaluation of clinical effect with electromyography].

    PubMed

    Mezaki, T; Kaji, R; Kimura, J; Ogawa, N

    1999-05-01

    Forty-one patients with hemifacial spasm had an injection of type A botulinum toxin (AGN 191622; Allergan Co. Ltd., Irvine, CA). Patients were randomly divided into 3 groups by the injection dose: group L (1 unit; 14 patients), group M (5 units; 14 patients), and group H (10 units; 13 patients). Half of the dose was injected into the orbicularis oculi and the rest into the zygomaticus major muscles on the affected side. The clinical effect and electromyogram were evaluated at 2 weeks after the injection. The clinical benefit was dependent on the injection dose, and group H showed the highest rate of improvement (84.6%). No adverse effect related to the toxin was demonstrated except one patient in group H who showed mild and transient lagophthalmos. For 81.8% of group H patients, the final judgement was "useful" or "very useful", which was 9.1% for group L and 50.0% for group M. On the other hand, electromyography disclosed no consistent dose-finding relationship. We conclude that at least 10 (preferably more) units of botulinum toxin are necessary for effectively treating hemifacial spasm. Electromyography has only limited value for the evaluation of clinical effect.

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

    PubMed

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

    2013-11-01

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

  11. ["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

  12. ["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

  13. 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.

  14. 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

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

    PubMed Central

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

    2010-01-01

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

  16. 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…

  17. 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…

  18. 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

  19. 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

  20. 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.

  1. 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

  2. [Tinnitus during headache: clinical-instrumental evaluation].

    PubMed

    Farri, A; Enrico, A; Lacilla, M; Sartoris, A

    1999-04-01

    During the five years running from December 1993 to January 1998, 112 patients who had come to our University Clinic suffering from headache were examined. From this group 71 complaining of tinnitus during headache were recruited for the study: 19 patients suffered from migraine without aura, 8 migraine with aura, 15 tension headache, 21 mixed headache, 3 basic migraine and 5 cluster headache. The purpose of this work was to determine the incidence and to identify the frequency of the various types of tinnitus in the study sample. Once cardiovascular and metabolic pathologies, previous cranial or cervical traumas, barotrauma, chronic on-the-job noise exposure, cervical arthritis, ATM malocclusion, use of drugs that damage the hearing apparatus, morbose processes of the external and middle ear, otosclerosis, jugular tympanum paraganglioma, Meniere's disease, acoustic neurinoma were all ruled out, the patients underwent the following battery of instrumental tests: tonal audiometry, impedance measurement, vestibular examination, electronystagmography, ABR, simplified tinnitometry. Only those patients with normal hearing underwent the tinnitometry and, therefore, the type of tinnitus was established only for this group of 53 patients. Tinnitometry showed that 37% of these subjects had tinnitus at the higher frequency tones, 11% at the middle frequencies, 29% complained of tinnitus at the lower frequencies while 23% complained that the bothersome buzzing was a compound noise. In addition, the subjective intensity of the tinnitus was analyzed. The authors devised a tinnitus irritation scale covering a range from 0 (not irritating) to 10 (intolerable). The tinnitus was bilateral in 66% of the cases while it was limited to only one ear in the remaining 34%. In 15% of the cases tinnitus was present even when there was no headache. In the literature, the etiopathogenesis of tinnitus associated with migraine headache has been attributed to vascular and neuropeptide mechanisms

  3. [Clinical evaluation tools of total hip arthroplasties].

    PubMed

    Hamadouche, M

    2006-10-01

    Total hip arthroplasty is one of the most efficient hip surgery procedures enabling improved function in the vast majority of operated patients. The major long-term complication is aseptic loosening due to an inflammatory response to particle wear debris coming from the bearings. Polyethylene is the key culprit. Currently two solutions are proposed: eliminating polyethylene from the prosthetic articulation or reducing material wear. This leads to the need for reliable tools for evaluating short-term results, predictive of long-term outcome. When the innovation concerns reduction of polyethylene wear, short-term wear should be measured with software methods or radiostereometry. If the innovation concerns improvement of polyethyleneless implants, then short-term migration should be measured with EBRA or radiostereometry. In addition, the long-term retrospective evaluation of large series of patients remains of major interest provided that it is performed with survival analysis. These different methods are detailed in this study, indicating the pros and cons for each solution. PMID:17088755

  4. Informed consent as an ethical requirement in clinical trials: an old, but still unresolved issue. An observational study to evaluate patient's informed consent comprehension.

    PubMed

    Sanchini, Virginia; Reni, Michele; Calori, Giliola; Riva, Elisabetta; Reichlin, Massimo

    2014-04-01

    We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

  5. 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

  6. 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.

  7. Pyrolysis system evaluation study

    NASA Technical Reports Server (NTRS)

    1974-01-01

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

  8. MR-guidance – a clinical study to evaluate a shuttle- based MR-linac connection to provide MR-guided radiotherapy

    PubMed Central

    2014-01-01

    Background The purpose of this clinical study is to investigate the clinical feasibility and safety of a shuttle-based MR-linac connection to provide MR-guided radiotherapy. Methods/Design A total of 40 patients with an indication for a neoadjuvant, adjuvant or definitive radiation treatment will be recruited including tumors of the head and neck region, thorax, upper gastrointestinal tract and pelvic region. All study patients will receive standard therapy, i.e. highly conformal radiation techniques like CT-guided intensity-modulated radiotherapy (IMRT) with or without concomitant chemotherapy or other antitumor medication, and additionally daily short MR scans in treatment position with the same immobilisation equipment used for irradiation for position verification and imaging of the anatomical and functional changes during the course of radiotherapy. For daily position control, skin marks and a stereotactic frame will be used for both imaging modalities. Patient transfer between the MR device and the linear accelerator will be performed with a shuttle system which uses an air-bearing patient platform for both procedures. The daily acquired MR and CT data sets will be digitally registrated, correlated with the planning CT and compared with each other regarding translational and rotational errors. Aim of this clinical study is to establish a shuttle-based approach for realising MR-guided radiotherapy for certain clinical situations. Second objectives are to compare MR-guided radiotherapy with the gold standard of CT image guidance for quality assurance of radiotherapy, to establish an appropiate MR protocol therefore, and to assess the possibility of using MR-based image guidance not only for position verification but also for adaptive strategies in radiotherapy. Discussion Compared to CT, MRI might offer the advantage of providing IGRT without delivering an additional radiation dose to the patients and the possibility of optimisation of adaptive therapy

  9. 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.

  10. 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

  11. Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracoporeal shockwave therapy (ESWT) device: a North American confirmatory study.

    PubMed

    Kudo, Patricia; Dainty, Katie; Clarfield, Michael; Coughlin, Larry; Lavoie, Pauline; Lebrun, Constance

    2006-02-01

    Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (+/-10) reaching an approximated total energy delivery of 1,300 mJ/mm(2) (ED+) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; and between treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis.

  12. 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

  13. [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

  14. 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

  15. [Clinical pilot study to evaluate the efficacy of a preservative-free hypertonic ophthalmic solution for patients with symptomatic corneal edema].

    PubMed

    Rouland, J-F

    2015-11-01

    This exploratory clinical trial aims to assess the effect on visual acuity and central corneal thickness of an unpreserved hypertonic ophthalmic solution containing sodium chloride (5%) and sodium hyaluronate, in patients with chronic corneal edema caused by endothelial disease reducing their visual acuity. Twenty patients were enrolled and treated with the hypertonic solution (1 to 2 drops per eye, 4 times a day over 28 days). Progression of visual acuity (ETDRS score) and corneal thickness (ultrasonic pachymetry) was measured from baseline (without treatment) through the treatment period (Day 7 and Day 28). The analyses were performed on 18 patients (Full Analysis Set [FAS] population). The causes of corneal edema were Fuchs endothelial dystrophy in 10 cases and post-cataract surgery endothelial decompensation in 8 patients. The mean visual acuity values for the FAS population compared between baseline (Day-7) and one week of treatment (Day+7) show a significant 5-point VA improvement (P<0.001 paired Wilcoxon test). For corneal thickness, there was also a significant decrease (P=0.033 paired Wilcoxon test). Functional improvement was observed at 28 days of instillation. No adverse events were recorded during the clinical study. In conclusion, the unpreserved hyperosmolar solution containing sodium chloride and sodium hyaluronate significantly improved ETDRS visual acuity after one week of use. In this clinical trial, the solution also showed excellent tolerability results.

  16. 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.

  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 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

  18. 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

  19. Prospective Clinical Study of Precision Oncology in Solid Tumors.

    PubMed

    Sohal, Davendra P S; Rini, Brian I; Khorana, Alok A; Dreicer, Robert; Abraham, Jame; Procop, Gary W; Saunthararajah, Yogen; Pennell, Nathan A; Stevenson, James P; Pelley, Robert; Estfan, Bassam; Shepard, Dale; Funchain, Pauline; Elson, Paul; Adelstein, David J; Bolwell, Brian J

    2015-11-09

    Systematic studies evaluating clinical benefit of tumor genomic profiling are lacking. We conducted a prospective study in 250 patients with select solid tumors at the Cleveland Clinic. Eligibility required histopathologic diagnosis, age of 18 years or older, Eastern Cooperative Oncology Group performance status 0-2, and written informed consent. Tumors were sequenced using FoundationOne (Cambridge, MA). Results were reviewed at the Cleveland Clinic Genomics Tumor Board. Outcomes included feasibility and clinical impact. Colorectal (25%), breast (18%), lung (13%), and pancreatobiliary (13%) cancers were the most common diagnoses. Median time from consent to result was 25 days (range = 3-140). Of 223 evaluable samples, 49% (n = 109) of patients were recommended a specific therapy, but only 11% (n = 24) received such therapy: 12 on clinical trials, nine off-label, three on-label. Lack of clinical trial access (n = 49) and clinical deterioration (n = 29) were the most common reasons for nonrecommendation/nonreceipt of genomics-driven therapy.

  20. A mixed methods study to evaluate the clinical and cost-effectiveness of a self-managed exercise programme versus usual physiotherapy for chronic rotator cuff disorders: protocol for the SELF study

    PubMed Central

    2012-01-01

    Background Shoulder pain is the third most common reason for consultation with a physiotherapist and up to 26% of the general population might be expected to experience an episode at any one time. Disorders of the shoulder muscles and tendons (rotator cuff) are thought to be the commonest cause of this pain. The long-term outcome is frequently poor despite treatment. This means that many patients are exposed to more invasive treatment, e.g. surgery, and/or long-term pain and disability. Patients with this disorder typically receive a course of physiotherapy which might include a range of treatments. Specifically the value of exercise against gravity or resistance (loaded exercise) in the treatment of tendon disorders is promising but appears to be under-used. Loaded exercise in other areas of the body has been favourably evaluated but further investigation is needed to evaluate the impact of these exercises in the shoulder and particularly the role of home based or supervised exercise versus usual treatment requiring clinic attendance. Methods/Design A single-centre pragmatic unblinded parallel group randomised controlled trial will evaluate the effectiveness of a self-managed loaded exercise programme versus usual clinic based physiotherapy. A total of 210 study participants with a primary complaint of shoulder pain suggestive of a rotator cuff disorder will be recruited from NHS physiotherapy waiting lists and allocated to receive a programme of self-managed exercise or usual physiotherapy using a process of block randomisation with sealed opaque envelopes. Baseline assessment for shoulder pain, function and quality of life will be undertaken with the Shoulder Pain & Disability Index, the Patient Specific Functional Scale and the SF-36. Follow-up evaluations will be completed at 3, 6 and 12 months by postal questionnaire. Both interventions will be delivered by NHS Physiotherapist’s. An economic analysis will be conducted from an NHS and Personal Social

  1. Clinical Use and Evaluation of Insulin Pens

    PubMed Central

    Ginsberg, Barry H.

    2015-01-01

    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

  2. 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

  3. 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

  4. 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

  5. Effects of topical boswellic acid on photo and age-damaged skin: clinical, biophysical, and echographic evaluations in a double-blind, randomized, split-face study.

    PubMed

    Pedretti, Alessandra; Capezzera, Rossana; Zane, Cristina; Facchinetti, Elena; Calzavara-Pinton, Piergiacomo

    2010-04-01

    Boswellic acids (BAs) are pentacyclic triterpenes with strong anti-inflammatory activity; their most important source is the extract of the gum resin of Boswellia serrata, a tropical tree that grows in India and Africa. In the present randomized, double-blind, split-face, comparative study we have assessed efficacy, tolerability, and safety of a base cream containing 0.5 % BAs as compared to the same cream without these active ingredients in the treatment of clinical manifestations of photoaging of facial skin. Fifteen female volunteers were enrolled; they applied creams once daily for 30 days. At baseline, at the end of the treatment, and after a 2-month follow-up, clinical findings were assessed according to the Dover classification scale for photoaging and by biophysical and ecographic measurements. We registered a significant improvement of tactile roughness and fine lines in the half side of the face treated with BAs; noninvasive instrumental diagnostic investigations showed an improvement of elasticity, a decrease of sebum excretion, and a change of echographic parameters suggesting a reshaping of dermal tissue. The treatment was always well tolerated without adverse effects. The present findings seem to indicate that the topical application of BAs may represent a suitable treatment option for selected features of skin photoaging.

  6. 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…

  7. A Model for Evaluating Student Clinical Psychomotor Skills.

    ERIC Educational Resources Information Center

    And Others; Fiel, Nicholas J.

    1979-01-01

    A long-range plan to evaluate medical students' physical examination skills was undertaken at the Ingham Family Medical Clinic at Michigan State University. The development of the psychomotor skills evaluation model to evaluate the skill of blood pressure measurement, tests of the model's reliability, and the use of the model are described. (JMD)

  8. 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

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

    PubMed

    Heimbeck, Alexander; Hölter, Gerd

    2011-05-01

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

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

    PubMed

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

    2014-01-01

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

  11. Clinical laboratory evaluation of the thermonuclease test.

    PubMed

    Shanholtzer, C J; Peterson, L R

    1982-05-01

    Simultaneous testing for clumping factor, coagulase, deoxyribonuclease, and thermonuclease was performed on 189 clinical isolates of gram-positive cocci with strong catalase activity to determine the suitability of the thermonuclease test as a routine procedure for the identification of Staphylococcus aureus. Positive reactions to all four tests were exhibited by 72 of the strains while 88 of the isolates gave uniformly negative results. Although discrepancies were found between the reactions of 29 organisms, differences were found between the reactions of 29 organisms, differences between tube coagulase ant thermonuclease results were rare. Greater than 90% of positive reactions for both tube coagulase and thermonuclease tests were detected within a four-hour incubation period. The thermonuclease test was found to be simple, reliable, inexpensive and rapid. This test gave easily interpretable reactions within an eight-hour workday, even when only one or two isolated colonies were used for testing. The thermonuclease test is well suited for use as a primary clinical laboratory procedure for the identification of Staphylococcus aureus.

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

    PubMed Central

    Vena, Alessandro; Carey, Jason; Badawi, Hisham

    2007-01-01

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

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

    PubMed Central

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

    2015-01-01

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

  14. A prospective, randomized clinical study evaluating the effect of transdermal continuous oxygen therapy on biological processes and foot ulcer healing in persons with diabetes mellitus.

    PubMed

    Driver, Vickie R; Yao, Min; Kantarci, Alpdogan; Gu, Guosheng; Park, Nanjin; Hasturk, Hatice

    2013-11-01

    Hypoxia is a major factor in delayed wound healing. The aim of this prospective, randomized, clinical trial was to compare outcomes of treatment in persons with chronic diabetic foot ulcers (DFUs) randomly assigned to transdermal continuous oxygen therapy (TCOT) for 4 weeks as an adjunct to standard care (debridement, offloading, and moisture). Nine patients (age 58.6±7.1, range 38-73 years) received TCOT (treatment group) and eight patients (age 59.9±12.6, range 35-76 years) received standard care alone (control group). Most patients (12) were male, and all had a Wagner I or II foot ulcer for an average of 14 (control group) or 20 months (treatment group). Weekly wound measurements and wound tissue biopsies were obtained and wound fluid collected. Levels of pro-inflammatory cytokines and proteases in wound fluid samples were analyzed using Luminex-based multiplex assays. Tissue-resident macrophages were quantified by immunohistochemistry. At week 4, average wound size reduction was 87% (range 55.7% to 100%) in the treatment group compared to 46% (15% to 99%) in the control group (P <0.05). Changes in cytokine levels (IL-6, IL-8) and proteinases (MMP-1,-2,-9, TIMP-1) at weeks 2 to 4 in wound fluid correlated with clinical findings. CD68+ macrophage counts showed statistically significant reduction in response to TCOT compared to the control group (P <0.01). The results of this study show that TCOT may facilitate healing of DFUs by reversing the inflammatory process through reduction in pro-inflammatory cytokines and tissue-degrading proteases. Additional research to elucidate the effects of this treatment on complete healing and increase understanding about the role of wound fluid analysis is needed.

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

    PubMed

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

    2013-06-01

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

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

    PubMed

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

    2013-06-01

    Antemortem studies pertaining to the manatee cardiovascular and cardiopulmonary systems are limited despite reports of cardiac disease in postmortem specimens. The objective of this project was to develop a technique for echocardiography in the Florida manatee (Trichechus manatus latirostris). Because of their unique anatomy, a ventral approach was employed by use of an echocardiography table designed specifically for this study. Fourteen clinically healthy, free-ranging and captive Florida manatees underwent echocardiography between the fall of 2011 and winter of 2012. Eight females and six males of various age categories were included in the study. Clear visualization of all valves and chambers was accomplished, and length and width measurements of the left atrium, peak aortic flow velocity, and ejection fraction percentage were calculated in most animals. Abnormalities observed during the study included atrioventricular regurgitation and severe right-atrial enlargement. Based on the results of this study, echocardiography in the Florida manatee is possible, which has both clinical and research implications in larger epidemiologic studies evaluating diseases of the cardiopulmonary and cardiovascular systems. PMID:23805547

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

    PubMed

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

    2016-01-01

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

  18. Clinical Evaluation of Heart Failure: Agreement among Tests

    PubMed Central

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

    2016-01-01

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

  19. A pilot study evaluating 99mTc-anti-TNF-alpha scintigraphy in graves' ophtalmopathy patients with different clinical activity score.

    PubMed

    Rebelo Pinto, E dos S; Lopes, F P P L; de Souza, S A L; da Fonseca, L M B; Vaisman, M; Gutfilen, B; dos Santos Teixeira, P de F

    2013-09-01

    The present study describes the preliminary results of the use of 99mTc-anti-TNF-α scintigraphy as a new diagnostic approach to evaluate patients presenting with Graves' ophthalmopathy (GO). Patients (n=25) presenting at different inflammatory stages of GO and 10 healthy volunteers underwent 99mTc-anti-TNF-α scintigraphy. Images were obtained 15 min after the intravenous injection of 370 MBq (10 mCi) 99mTc-anti-TNF-α. Planar images were obtained in a 256×256 matrix (each lasting 5 min) and single photon emission computed tomography (SPECT) scan lasting 13 min. Regions of interest (ROI) were drawn on the orbit and cerebral hemispheres. The uptake of 99m Tc-anti-TNF-α in these regions was compared and positive scintigraphy established when the ROI was >2.5. In addition, uptake for each positive exam was scored as either slight (2.6-5.1), moderate (5.2-7.6), or high (>7.6). In this pilot study, 69 orbits were evaluated (1 patient had only 1 eye), and 27 had a positive CAS (≥3/7). Scintigraphies were positive in 38 orbits. Comparing the results of the exams with CAS, a high sensitivity and negative predictive values were determined for scintigraphy (96.3% and 96.7%, respectively). However, the specificity and the positive predictive values were 71.4% and 68.4%, respectively, with an accuracy of 81.2%. The exclusion of examinations that were slightly positive from the analysis resulted in an improvement in test accuracy (95.5%). The preliminary results suggest that 99mTc-anti-TNF-α scintigraphy is a promising procedure for the evaluation of active orbital inflammation in GO. PMID:23918686

  20. Evaluation of clinical teaching models for nursing practice.

    PubMed

    Croxon, Lyn; Maginnis, Cathy

    2009-07-01

    Clinical placements provide opportunities for student nurses to learn experientially. To create a constructive learning environment staff need to be friendly, approachable, available and willing to teach. There must be adequate opportunities for students to develop confidence and competence in clinical skills with a focus on student learning needs rather than service needs of facilities. A popular model for clinical teaching of nursing students is the preceptor model. This model involves a student working under the supervision of individual registered nurses who are part of the clinical staff. This model was failing to meet students' needs in acute nursing practice areas, largely due to Registered Nurse staff shortages and demanding workloads. The students' evaluations led to the trial of a 'cluster' or group model of eight students, with a clinical facilitator who is paid by the university, in each acute nursing ward. Evaluation of twenty nursing students' perceptions of their acute nursing practice clinical placements was conducted using a mixed method approach to evaluate the two models of student supervision. Results indicate that the students prefer small groups with the clinical facilitator in one area. Thus evaluation and feedback from students and the perceptions of their clinical placement is essential. PMID:18722161

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

    PubMed

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

    2015-01-01

    The aim of the present study was to investigate the clinical efficacy of herbal medicines (1 gm tulsi and 1 gm turmeric mixed in glycerine base) for the treatment of oral submucous fibrosis (OSMF). Forty-one patients in the age group of 17- 56 years without any systemic complications were included in the study. The patients were treated with medicines, which were to be applied 3-4 times a day. Blood samples were collected before and after treatment to screen for any systemic changes due to these medications. Burning sensation and mouth opening were recorded before and after treatment. Patients were followed up on monthly subsequent visits for three months. Changes in the burning sensation on visual analogue scale (VAS) scale and difference in the mouth opening were analyzed statistically. A statistically significant improvement was seen in both burning sensation and mouth opening. Tulsi and turmeric offers a safe and efficacious combination of natural products available for symptomatic treatment of OSMF. PMID:25878464

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

    PubMed

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

    2016-04-01

    This paper explored concepts, definitions and theoretical perspectives evaluating clinical competence during nursing education. The questions were: (i) How is clinical competence evaluated? and (ii) What is evaluated? An integrative review of 19 original research articles from 2009 to 2013 was performed. Results showed that evaluation tools were used in 14, observations in 2 and reflecting writing in 3 studies. The students participated in all but one evaluation alone or together with peers, faculty members or preceptors. Three themes were found: (i) professional practice with a caring perspective; (ii) clinical skills and reflective practice; and (iii) cognitive, affective and psychomotor skills both with a nursing perspective. This review shows an emphasis on structured methods with a risk reducing nursing to tasks and skills why combinations with qualitative evaluations are recommended. A holistic view of competence dominated and in designing evaluations, explicit perspectives and operationalized definitions of clinical competence became evident. PMID:26369943

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

    NASA Astrophysics Data System (ADS)

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

    2011-03-01

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

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

    PubMed

    Keipert, Peter E

    2016-01-01

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

  5. 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

  6. Real-time three-dimensional color doppler evaluation of the flow convergence zone for quantification of mitral regurgitation: Validation experimental animal study and initial clinical experience

    NASA Technical Reports Server (NTRS)

    Sitges, Marta; Jones, Michael; Shiota, Takahiro; Qin, Jian Xin; Tsujino, Hiroyuki; Bauer, Fabrice; Kim, Yong Jin; Agler, Deborah A.; Cardon, Lisa A.; Zetts, Arthur D.; Panza, Julio A.; Thomas, James D.

    2003-01-01

    BACKGROUND: Pitfalls of the flow convergence (FC) method, including 2-dimensional imaging of the 3-dimensional (3D) geometry of the FC surface, can lead to erroneous quantification of mitral regurgitation (MR). This limitation may be mitigated by the use of real-time 3D color Doppler echocardiography (CE). Our objective was to validate a real-time 3D navigation method for MR quantification. METHODS: In 12 sheep with surgically induced chronic MR, 37 different hemodynamic conditions were studied with real-time 3DCE. Using real-time 3D navigation, the radius of the largest hemispherical FC zone was located and measured. MR volume was quantified according to the FC method after observing the shape of FC in 3D space. Aortic and mitral electromagnetic flow probes and meters were balanced against each other to determine reference MR volume. As an initial clinical application study, 22 patients with chronic MR were also studied with this real-time 3DCE-FC method. Left ventricular (LV) outflow tract automated cardiac flow measurement (Toshiba Corp, Tokyo, Japan) and real-time 3D LV stroke volume were used to quantify the reference MR volume (MR volume = 3DLV stroke volume - automated cardiac flow measurement). RESULTS: In the sheep model, a good correlation and agreement was seen between MR volume by real-time 3DCE and electromagnetic (y = 0.77x + 1.48, r = 0.87, P <.001, delta = -0.91 +/- 2.65 mL). In patients, real-time 3DCE-derived MR volume also showed a good correlation and agreement with the reference method (y = 0.89x - 0.38, r = 0.93, P <.001, delta = -4.8 +/- 7.6 mL). CONCLUSIONS: real-time 3DCE can capture the entire FC image, permitting geometrical recognition of the FC zone geometry and reliable MR quantification.

  7. Comparative evaluation of the relative efficacy of the free mucosal graft and periosteal fenestration for increasing the vestibular depth - A clinical study

    PubMed Central

    Yadav, Nisha; Khattak, Braham Prakash; Misra, Shobhana; Sharma, Anamika

    2014-01-01

    Purpose: The aim of the present study was to compare the periosteal fenestration (PF) and free mucosal graft (FMG) techniques in mandibular anterior region to increase the vestibular depth. Methodology: A total of 20 systemically healthy cases (10 patients in each group) with shallow vestibular depth and reduced width of attached gingiva in lower anterior region were included in the present study. Clinical parameters recorded included Gingival index (GI), Plaque index (PI), Oral hygiene index simplified (OHI S), Vestibular depth (VD), width of attached gingiva and post operative discomfort. Findings: The results at the end of 3 months showed that the mean GI, PI, OHI S decreased significantly and remained low throughout the study period. The mean gain in percentage of vestibular depth at the end of 3 months for group 1(PF) was 48.4% with relapse of 7.2% from the baseline. For group 2 (FMG), the mean gain in percentage of vestibular depth at the end of 3 months for was 50% with relapse of 6.2% from the baseline. The mean gain in percentage of attached gingiva at 3 months for group 1 and 2 was 65.9% and 74%, respectively. In comparison of group 1 and 2, group 2 showed better results in terms of increasing the vestibular depth and attached gingiva than group 1 although the intergroup comparison was not statistically significant. Conclusion: When aim of the clinician is to treat a patient with shallow vestibule together with reduced width of attached gingiva, the use of periosteal fenestration yields similar results to that of FMG. PMID:25191075

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

    PubMed Central

    Kieslich, Katharina; Littlejohns, Peter

    2015-01-01

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

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

    PubMed Central

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

    2015-01-01

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

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

    NASA Astrophysics Data System (ADS)

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

    1999-05-01

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

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

    PubMed

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

    2014-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2014-01-01

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

  14. Evaluating externship programs: impact of program length on clinical productivity.

    PubMed

    Mascarenhas, Ana Karina; Freilich, Sarah R; Henshaw, Michelle M; Jones, Judith A; Mann, Madalyn L; Frankl, Spencer N

    2007-04-01

    Community-based dental education programs such as externship programs have become an integral component of dental school education. Qualitative evaluation of externship programs has captured increased confidence, efficiency, skill, and independence among students. To better understand these findings, quantitative evaluation of the externship experience is necessary. The current study investigated the clinical care (defined as dental procedures) provided by Boston University School of Dental Medicine students who completed six-week general dentistry externships compared to those completing ten-week general dentistry externships. Results indicate that the scope of services provided in the ten-week externship differed from the six-week externship. The longer externships allowed for students to perform more complex procedures toward the latter part of their externships. Students participating in the ten-week externship also provided more procedures per week than students in the six-week externship. Because scheduling of patient appointments is generally a function of the site, number of patient visits and procedures performed per patient did not differ between the two groups. Our findings provide insight into the reason why longer externships increase clinical confidence, efficiency, and skill. In the continuing effort to improve the externship experience in dental schools, these findings should be taken into consideration.

  15. Plantago ovata: Clinical study of overuse.

    PubMed

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

    2016-03-01

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

  16. Evaluation of the clinical efficacy of Biotène Oral Balance in patients with secondary Sjögren's syndrome: a pilot study.

    PubMed

    Aliko, Ardita; Alushi, Adem; Tafaj, Argjend; Isufi, Ramazan

    2012-09-01

    The objective of the present study was to evaluate the efficacy of Oral Balance saliva substitute in alleviating dry mouth symptoms in a sample of patients with secondary Sjögren's syndrome. Twenty-one consecutive secondary Sjögren's syndrome patients with dry mouth complaints and hyposalivation were included in this study. Patients used a lactoperoxidase-system-containing gel (Biotène Oral Balance) for 4 weeks. The effects on subjective oral symptoms were recorded by means of a 7-items questionnaire which contained questions regarding dry mouth sensation and its effect on chewing, swallowing, taste, speech, burning sensation and denture retention. The severity of symptoms was assessed using a visual analogical scale. Oral symptom scores and unstimulated whole salivary flow were recorded at baseline and after 4 weeks' use of the product. Two patients withdrew from the study, because of nausea and unpleasant taste caused by the product. Nineteen patients (all women, mean age 52.7 years) participated throughout the entire study. Wilcoxon signed-ranked tests indicated significant improvements in visual analogical scale scores posttreatment for 5 of the 7 items on the oral dryness questionnaire, although no increase in salivary flow was found. However, the improvement in certain variables did not take a positive course in all cases. Patients with lower salivary flow at baseline tended to have greater improvement in oral symptoms. The study suggests that the use of Oral Balance gel is effective in alleviating the dry mouth symptoms in secondary Sjögren's syndrome patients, but a randomized controlled trial is needed to assess the placebo effect.

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

    PubMed Central

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

    2012-01-01

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

  18. [Evidence-based medicine and real world study in clinical study of acupuncture and moxibustion].

    PubMed

    Cai, Ronglin; Hu, Ling; Wu, Zijian

    2015-09-01

    Evidence-based medicine (EBM) has been widely applied in clinical study of acupuncture and moxibustion, and the real-world study (RWS) has gradually become an important way of clinical research in the world in recent years. It is worthy of our in-depth study and discussion that how to evaluate the advantages and limitations of EBM and RWS as well as their reasonable application in clinical study of acupuncture and moxibustion. The characteristics and difference between RWS and EBM, and the situation of acupuncture clinical research methods are discussed in this paper. It is proposed that we should understand the advantages of RWS in acupuncture clinical research, fully realize the limitations of EBM and RWS, recognize the complexity and particularity of RWS, and apply EBM and RWS into acupuncture clinical research. Meanwhile acupuncture clinical manipulation standardization should be further promoted, which is benefit to develop clinical study, improve clinical efficacy and promote the popularization of acupuncture and moxibustion.

  19. Team clinical supervision in acute hospital wards: a feasibility study.

    PubMed

    O'Connell, Bev; Ockerby, Cherene M; Johnson, Susan; Smenda, Helen; Bucknall, Tracey K

    2013-03-01

    Clinical supervision provides a strategy to mitigate nurses' workplace stress and enhance retention, but the literature provides little guidance about its implementation beyond mental health nursing. This study explored the feasibility of implementing and evaluating ward-based team clinical supervision for general nurses on two separate wards at one public and one private hospital. Nurses completed the Work Environment Questionnaire pre- (n = 36) and postintervention (n = 27), and focus groups (n = 20) explored their perceptions of supervision. Staff were unfamiliar with clinical supervision, so information sessions were required. The questionnaire may not have been suitable to evaluate this type of intervention. Focus group findings revealed that team supervision improved communication, enhanced working relationships, and empowered nurses to challenge existing practices, which had a positive impact on their perceived stress. This study provides insights to guide implementation and evaluation of clinical supervision in acute settings. PMID:21531902

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

    PubMed

    Manjunatha, Roopa G; Rajanna, Konandur; Mahapatra, Roy D; Dorasala, Srinivas

    2013-01-01

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

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

    PubMed Central

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

    2013-01-01

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

  2. A double-blind, randomized, vehicle-controlled clinical study to evaluate the efficacy and safety of MAS063DP (ATOPICLAIR) in the management of atopic dermatitis in paediatric patients.

    PubMed

    Patrizi, Annalisa; Capitanio, Bruno; Neri, Iria; Giacomini, Federica; Sinagra, Jo L; Raone, Beatrice; Berardesca, Enzo

    2008-11-01

    A multicenter, randomized, double-blind, vehicle-controlled clinical study was conducted to evaluate the efficacy and safety of MAS063DP in 60 paediatric patients affected by atopic dermatitis (AD), aged between 2 and 17 years. Using the Investigator's Global Assessment (IGA) score for AD, patients with a score of 2 (mild) or 3 (moderate) were enrolled in the study. Patients were randomly selected to receive MAS063DP (20 patients), MAS060 (20 patients, a similar formulation with lower key ingredients' concentration and no preservatives) or vehicle (20 patients).The study consisted in a treatment period of 43 days, with clinical evaluations at baseline (day 1), days 8, 15, 22, 29 and 43, at which time the treatment was stopped. MAS063DP showed nearly 80% improvement in IGA score at day 22, compared with 16.6% and 26.3% with the MAS060 and vehicle respectively. A statistically significant difference was found by comparing MAS063DP with MAS060 (p < 0.0001); a similar result was evidenced comparing MAS063DP and vehicle (p = 0.001). By contrast, no significant difference was found between MAS060 and vehicle. A statistically significant difference was sustained until the end of the study. MAS063DP may therefore be considered as one of the available regimens effective in the treatment of mild-to-moderate AD in children and adolescents. PMID:18298424

  3. Social Studies. Microsift Courseware Evaluations.

    ERIC Educational Resources Information Center

    Northwest Regional Educational Lab., Portland, OR.

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

  4. Clinical evaluation of the shape of the suprascapular notch--an ultrasonographic and computed tomography comparative study: Application to shoulder pain syndromes.

    PubMed

    Polguj, Michał; Synder, Marek; Kwapisz, Adam; Stefańczyk, Katarzyna; Grzelak, Piotr; Podgórski, Michał; Topol, Mirosław

    2015-09-01

    The most common site of suprascapular nerve compression and injury is the suprascapular notch. The aim of this study was to assess the sensitivity and specificity of sonography in determining the type of suprascapular notch (SSN). Thirty randomized patients (60 upper extremities) underwent USG examination of the shoulder area. The results were further compared with three-dimensional reconstructions of the scapulae obtained through CT examination to place the SSNs within a fivefold classification. For identification of type I, the sensitivity was 73.3% and the specificity 97.8%. For identification of type III, the values was 96.9% and 85.7%, respectively. Type II was not found in USG examination. Discrimination between type IV and V was not possible. The mean distance between the line connecting the edges of the SSN and the skin was 38 mm in right-handed patients and 34 mm in ambidextrous subjects. Ultrasonographic examination of the SSN is characterized by high specificity for type I, and high sensitivity for type III SSN. Discrimination between type IV and V of the SSN is not recommended based on sonographic evaluation.

  5. A pilot study evaluating real-time shear wave ultrasound elastography of miscellaneous non-nodal neck masses in a routine head and neck ultrasound clinic.

    PubMed

    Bhatia, Kunwar S S; Yuen, Edmund H Y; Cho, Carmen C M; Tong, Cina S L; Lee, Yolanda Y P; Ahuja, Anil T

    2012-06-01

    A pilot study was performed to evaluate shear wave ultrasound elastography (SWE) for miscellaneous non-nodal/salivary/thyroid neck lesions. Forty-six lesions undergoing conventional sonography also underwent SWE. Elastic moduli from the stiffest areas in lesions were correlated with diagnosis. Forty lesions were benign (9 lipomas, 8 lymphatic/venous vascular malformations, 7 thyroglossal duct cysts, 4 branchial cleft cysts, 4 abscesses/phlegmons, 3 neurogenic tumors and 1 each of paraganglioma, sebaceous cyst, pseudotumor, hypertrophic scar, ranula) and 6 were malignant (1 malignant fibrous histiocytoma, 2 primary squamous cell carcinomas and 3 intramuscular metastases [2 squamous cell carcinomas, 1 malignant melanoma]).Median stiffness of malignant lesions (226.4 kPa, range 55.6 to 300.0) was higher than benign lesions (28.3 kPa, range 4.0 to 300.0) (p < 0.001). SWE cut-off with highest accuracy (174.4 kPa) achieved 83.3% sensitivity and 97.5% specificity, and the cut-off with 100% sensitivity (55.6 kPa) achieved 75% specificity. All malignant lesions were suspected on conventional sonography. The preliminary data indicate that SWE is feasible for miscellaneous neck lesions. SWE would not have altered management in terms of detecting undisclosed malignancies, although as a quantitative technique, it may increase the diagnostic confidence of less experienced operators performing head and neck ultrasound.

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

    NASA Astrophysics Data System (ADS)

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

    2012-03-01

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

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

    PubMed Central

    Rodriguez, Analiz; Anderson, James M.

    2009-01-01

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

  8. Evaluation of the Pharmacokinetics and Pharmacodynamics of Liposomal Amikacin for Inhalation in Cystic Fibrosis Patients with Chronic Pseudomonal Infections Using Data from Two Phase 2 Clinical Studies

    PubMed Central

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

    2014-01-01

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

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

    PubMed

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

    2014-09-01

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

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

    PubMed

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

    2015-01-01

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

  11. Using simulation to evaluate clinical competence after impairment.

    PubMed

    Raborn, G W; Carter, R M

    1999-01-01

    It is important for individual dentists and the profession to have access to a process for evaluating the clinical competence of practitioners who are professionally impaired as a result of an accident or a medical disability. No common standards for such evaluations currently exist, however, as demand for this type of assessment is still rare. This article reviews the evaluative approach taken by a team of experienced dental educators in examining three dentists who suffered from medical disabilities. An attempt was made to standardize the evaluation process by using clinical simulation to create an environment that would be comfortable for the dentists and acceptable to the lawyers and the insurance companies. Following evaluation, recommendations on individual competence were made, contributing to a faster resolution of legal and insurance issues.

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

    PubMed Central

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

    2008-01-01

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

  13. Evaluation of clinical and laboratory correlates of sickle leg ulcers.

    PubMed

    Madu, Anazoeze Jude; Ubesie, Agozie; Madu, Kenechi Anthony; Okwor, Bismarck; Anigbo, Chukwudi

    2013-01-01

    The exact mechanism for the occurrence of sickle leg ulcers (SLUs) has not been fully explained, although, popular opinion supports a multifactorial etio-pathogenetic process. Leg ulceration in sickle cell is a chronic and debilitating condition which is difficult to treat and may worsen the psychosocial impact of this illness. This study aims to evaluate the laboratory and clinical correlates of SLUs. One hundred sixty-seven patients who had been diagnosed with sickle cell anemia (homozygous S) had their steady-state hemoglobin concentration (Hb), hematocrit, white cell count, platelet count, serum bilirubin, and aspartate transaminase (AST) as well as frequency of crisis per annum evaluated with respect to their relationship to the occurrence of leg ulcers. They were aged 6-53 years (mean age 24.3 years), and prevalence of leg ulcer was found to be 2.75 per 1000 (2.54 per 1000 in females and 2.83 per 1000 in males). The independent sample t-test showed a significant difference in the serum AST levels in those with SLU (p = 0.029), though a positive correlation did not exist. Other predictors of disease severity found to have positive relationship with each other were the AST and total serum bilirubin 0.207 (p = 0.012); Hb and age 0.130 (p = 0.035); Hb and white cell count -0.159 (p = 0.010), white cell count and age -0.113 (p = 0.018). SLUs do not occur in patients with severe disease in sickle cell. The clinical and laboratory indicators of severe sickle cell disease do not correlate positively with the occurrence of SLU. Serum AST may have a relationship with leg ulceration in these patients. Environmental factors most likely play a major part in the etiopathogenesis of leg ulcer and this may require further studies in different sociocultural settings.

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

    PubMed

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

    2000-01-01

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

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

    PubMed

    Furukawa, Hiroshi

    2016-04-01

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

  16. An Overview of Clinical Studies on Fiber Post Systems

    PubMed Central

    Dikbas, Idil; Tanalp, Jale

    2013-01-01

    Intraradicular posts are useful adjuncts in the restoration of endodontically treated teeth. These systems have undergone a significant evolution in recent years, and fiber-reinforced systems have started to be incorporated into routine clinical care more frequently. Despite the high number of laboratory studies pertaining to the characteristics of fiber posts, clinical studies evaluating their general success rates are rather limited. Since clinical investigations are reliable means to achieve information about the general behavior pattern of materials or techniques, assessment of this data will be beneficial to have a better understanding of fiber-reinforced intraradicular post systems. The purpose of this paper was to make a summary of clinical studies regarding various fiber posts. A PubMed search was conducted and articles dating back to 1990 were retrieved. The paper provides an overview of clinical studies on fiber posts specifically in the last decade as well as commentary analysis. PMID:24250255

  17. [Application of minimum clinically important difference in the clinical study of acupuncturej and moxibustion].

    PubMed

    Zhang, Qiwen; Chen, Bo; Lv, Zhongxi; Guo, Yi; Guo, Yongming; Pan, Xingfang

    2016-03-01

    The current clinical efficacy evaluation system and evaluation methods of acupuncture have several limitations, and the application status is not optimistic. According to long-term observation, minimum clinically important difference (MCID) is consistent with the characteristics of clinical acupuncture, and has objective quanti- tative standard and wide applicability. Incorporating MCID into acupuncture clinical efficacy evaluation of tradition- al Chinese medicine can truly reflect the clinical effect of acupuncture and improve the disadvantages and shortcom- ings of acupuncture clinical evaluation, which could provide certain reference for building clinical efficacy evaluation system featured with TCM. PMID:27344843

  18. Diversity in clinical guidelines: the role of repertoires of evaluation.

    PubMed

    Moreira, Tiago

    2005-05-01

    Clinical practice guidelines are one of the main tools by which clinicians, policy makers and patients hope to make health care less variable, more reliable and efficient, but there is little understanding of the processes by which clinical guidance is put together by guideline groups. This paper describes the social organisation of knowledge within clinical practice guideline development processes by drawing on the sociology of situated judgement. Two guideline development processes were observed, and the development group meetings (N = 21) recorded and analysed qualitatively. Data analysis suggested that clinical guidance comes to existence through the combination of repertoires of evaluation, organised around four different epistemic criteria: robustness, usability, acceptability and adequacy. This research provides a detailed and layered understanding of the knowledge dynamics involved in developing recommendations for appropriate health care for specific clinical circumstance.

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed Central

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

    2016-01-01

    Aims: To investigate clinically and radiographically, the bone fill in extraction sockets using demineralized freeze-dried bone allograft alone and along with platelet-rich fibrin (PRF). Materials and Methods: A randomized controlled clinical trial was carried out on 36 nonrestorable single-rooted teeth sites. Sites were randomized into demineralized freeze-dried bone allograft (DFDBA) combined with PRF - test and DFDBA - control groups using a coin toss method. After the placement of graft material, collagen membrane was used to cover it. The clinical parameters recorded were ridge width and ridge height. All the parameters were recorded at baseline and at 90 and 180 days. Statistical Analysis Used: Independent t-test and paired t-test. Results: In both groups, there is significant reduction in loss of ridge width and ridge height from baseline to 90 days (P < 0.001), baseline to 180 days (P < 0.001), and 90–180 days (P < 0.001). However, when both the groups were compared the test group favored in the reduction of ridge width while there was no statistical difference in reduction of ridge height among at different intervals. Conclusions: Although DFDBA is considered as an ideal graft material, PRF can be used as an adjunctive with DFDBA for socket preservation. PMID:27630503

  1. Statistical Issues in TBI Clinical Studies

    PubMed Central

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

    2013-01-01

    The identification and longitudinal assessment of traumatic brain injury presents several challenges. Because these injuries can have subtle effects, efforts to find quantitative physiological measures that can be used to characterize traumatic brain injury are receiving increased attention. The results of this research must be considered with care. Six reasons for cautious assessment are outlined in this paper. None of the issues raised here are new. They are standard elements in the technical literature that describes the mathematical analysis of clinical data. The purpose of this paper is to draw attention to these issues because they need to be considered when clinicians evaluate the usefulness of this research. In some instances these points are demonstrated by simulation studies of diagnostic processes. We take as an additional objective the explicit presentation of the mathematical methods used to reach these conclusions. This material is in the appendices. The following points are made: (1) A statistically significant separation of a clinical population from a control population does not ensure a successful diagnostic procedure. (2) Adding more variables to a diagnostic discrimination can, in some instances, actually reduce classification accuracy. (3) A high sensitivity and specificity in a TBI versus control population classification does not ensure diagnostic successes when the method is applied in a more general neuropsychiatric population. (4) Evaluation of treatment effectiveness must recognize that high variability is a pronounced characteristic of an injured central nervous system and that results can be confounded by either disease progression or spontaneous recovery. A large pre-treatment versus post-treatment effect size does not, of itself, establish a successful treatment. (5) A procedure for discriminating between treatment responders and non-responders requires, minimally, a two phase investigation. This procedure must include a mechanism to

  2. Evaluation of HPV Genotyping Assays for Archival Clinical Samples.

    PubMed

    Lillsunde Larsson, Gabriella; Carlsson, Jessica; Karlsson, Mats G; Helenius, Gisela

    2015-05-01

    Human papillomavirus (HPV) testing and genotyping of FFPE tissue samples is important in epidemiological investigations. Here, we compare four different HPV genotyping methods for use in FFPE clinical samples. Comparative testing was performed on 99 samples with a clinical suspicion of HPV. Specimens were analyzed with Anyplex II HPV28 detecting 28 genotypes using real-time PCR and melting curve analysis, CLART HPV2 detecting 35 genotypes using PCR and microarray detection, and MGP5+/6+ consensus primer system together with pyrosequencing. Results were compared to a real-time PCR reference protocol detecting 14 genotypes. In total, 68% of the samples were positive for an HPV genotype using the reference protocol and MGP5+/6+ primer system. Anyplex II HPV28 analysis and CLART HPV2 had 82% and 72% positive samples, respectively. All four methods showed good agreement when comparing the 14 genotypes included in the reference protocol. When evaluating all genotypes, the Anyplex II HPV28 assay and the CLART assay changed the status of the sample (individually or together) from negative with respect to the reference protocol to positive for either a Group 1 (n = 4) or Group 2 (n = 6) genotype. We conclude from this study that for an extended genotyping approach with a high sensitivity for FFPE specimens, both the Anyplex II HPV28 and CLART HPV2 assays are suitable alternatives despite minor intra-assay differences.

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

    PubMed

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

    2005-01-01

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

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

    PubMed

    Dilts, David M

    2013-12-01

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

  5. Clinical evaluation of metastases of malignant melanoma imaging with 99Tcm-glutathione and 99Tcm-anti-melanoma antibody: a comparative study.

    PubMed

    Duman, Y; Burak, Z; Ercan, M T; Dirlik, A; Bilkay, B C; Akin, Y; Taner, M; Bekdik, C F

    1995-11-01

    The aim of this investigation was to test for the scintigraphic detection of metastases of malignant melanoma with a new radiopharmaceutical, 99Tcm-glutathione (99Tcm-GSH), in comparison with 99Tcm-anti-melanoma antibody (99Tcm-AMAb). Glutathione was labelled with 99Tcm by a Sn2+ reduction method with an efficiency of > 99% as determined by instant thin layer chromatography (ITLC). Anti-melanoma antibody was obtained as a kit from SORIN (Italy) and labelled with 99TcmO-4. Forty-three patients with a total of 55 biopsy-proven metastatic melanoma foci, 1 ocular melanoma and 20 benign pathologic foci, also confirmed by ultrasound, computed tomography and magnetic resonance imaging, were included in the study after giving their informed consent. Following the intravenous (i.v.) injection of 500 MBq 99Tcm-AMAb, scintigraphic images of the involved areas were obtained 6 h post-injection. Three days later, the same patients were given 500 MBq 99Tcm-GSH i.v. and images were obtained 6 and 24 h post-injection. The images were classified as positive (focal abnormal accumulation) or negative. Quantitative evaluation was also applied. Regions of interest were drawn over the involved areas and nearby soft tissues and the target-to-nontarget (T/NT) ratios obtained with 99Tcm-AMAb (T/NT: 1.92 +/- 0.2) and 99Tcm-GSH (T/NT: 1.84 +/- 0.2) were compared (0.1 < P < or = 0.3). The sensitivity (and specificity) of 99Tcm-AMAb and 99Tcm-GSH in the detection of malignant melanoma metastases were 91% (95%) and 84% (90%), respectively. Compared with 99Tcm-AMAb, the advantages of 99Tcm-GSH are lower levels of blood radioactivity, lower costs and easy in-house preparation. In conclusion, our results show that 99Tcm-GSH is a potentially useful radiopharmaceutical for the detection of metastases of malignant melanoma.

  6. [Clinical evaluation of a novel HBsAg quantitative assay].

    PubMed

    Takagi, Kazumi; Tanaka, Yasuhito; Naganuma, Hatsue; Hiramatsu, Kumiko; Iida, Takayasu; Takasaka, Yoshimitsu; Mizokami, Masashi

    2007-07-01

    The clinical implication of the hepatitis B surface antigen (HBsAg) concentrations in HBV-infected individuals remains unclear. The aim of this study was to evaluate a novel fully automated Chemiluminescence Enzyme Immunoassay (Sysmex HBsAg quantitative assay) by comparative measurements of the reference serum samples versus two independent commercial assays (Lumipulse f or Architect HBsAg QT). Furthermore, clinical usefulness was assessed for monitoring of the serum HBsAg levels during antiviral therapy. A dilution test using 5 reference-serum samples showed linear correlation curve in range from 0.03 to 2,360 IU/ml. The HBsAg was measured in total of 400 serum samples and 99.8% had consistent results between Sysmex and Lumipulse f. Additionally, a positive linear correlation was observed between Sysmex and Architect. To compare the Architect and Sysmex, both methods were applied to quantify the HBsAg in serum samples with different HBV genotypes/subgenotypes, as well as in serum contained HBV vaccine escape mutants (126S, 145R). Correlation between the methods was observed in results for escape mutants and common genotypes (A, B, C) in Japan. Observed during lamivudine therapy, an increase in HBsAg and HBV DNA concentrations preceded the aminotransferase (ALT) elevation associated with drug-resistant HBV variant emergence (breakthrough hepatitis). In conclusion, reliability of the Sysmex HBsAg quantitative assay was confirmed for all HBV genetic variants common in Japan. Monitoring of serum HBsAg concentrations in addition to HBV DNA quantification, is helpful in evaluation of the response to lamivudine treatment and diagnosis of the breakthrough hepatitis.

  7. Detecting referral and selection bias by the anonymous linkage of practice, hospital and clinic data using Secure and Private Record Linkage (SAPREL): case study from the evaluation of the Improved Access to Psychological Therapy (IAPT) service

    PubMed Central

    2011-01-01

    Background The evaluation of demonstration sites set up to provide improved access to psychological therapies (IAPT) comprised the study of all people identified as having common mental health problems (CMHP), those referred to the IAPT service, and a sample of attenders studied in-depth. Information technology makes it feasible to link practice, hospital and IAPT clinic data to evaluate the representativeness of these samples. However, researchers do not have permission to browse and link these data without the patients' consent. Objective To demonstrate the use of a mixed deterministic-probabilistic method of secure and private record linkage (SAPREL) - to describe selection bias in subjects chosen for in-depth evaluation. Method We extracted, pseudonymised and used fuzzy logic to link multiple health records without the researcher knowing the patient's identity. The method can be characterised as a three party protocol mainly using deterministic algorithms with dynamic linking strategies; though incorporating some elements of probabilistic linkage. Within the data providers' safe haven we extracted: Demographic data, hospital utilisation and IAPT clinic data; converted post code to index of multiple deprivation (IMD); and identified people with CMHP. We contrasted the age, gender, ethnicity and IMD for the in-depth evaluation sample with people referred to IAPT, use hospital services, and the population as a whole. Results The in IAPT-in-depth group had a mean age of 43.1 years; CI: 41.0 - 45.2 (n = 166); the IAPT-referred 40.2 years; CI: 39.4 - 40.9 (n = 1118); and those with CMHP 43.6 years SEM 0.15. (n = 12210). Whilst around 67% of those with a CMHP were women, compared to 70% of those referred to IAPT, and 75% of those subject to in-depth evaluation (Chi square p < 0.001). The mean IMD score for the in-depth evaluation group was 36.6; CI: 34.2 - 38.9; (n = 166); of those referred to IAPT 38.7; CI: 37.9 - 39.6; (n = 1117); and of people with CMHP 37.6; CI 37

  8. A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis

    PubMed Central

    2013-01-01

    Introduction The aim of this study was to evaluate the safety, pharmacokinetics, and clinical response of brodalumab (AMG 827), a human, anti-IL-17 receptor A (IL-17RA) monoclonal antibody in subjects with moderate-to-severe rheumatoid arthritis (RA). Methods This phase Ib, randomized, placebo-controlled, double-blind multiple ascending dose study enrolled subjects with moderate to severe RA (≥6/66 swollen and ≥8/68 tender joints). Subjects were randomized 3:1 to receive brodalumab (50 mg, 140 mg, or 210 mg subcutaneously every two weeks for 6 doses per group; or 420 mg or 700 mg intravenously every 4 weeks for two doses per group) or placebo. Endpoints included incidence of adverse events (AEs) and pharmacokinetics. Exploratory endpoints included pharmacodynamics, and improvements in RA clinical metrics. Results Forty subjects were randomized to investigational product; one subject discontinued due to worsening of RA (placebo). The study was not designed to assess efficacy. AEs were reported by 70% (7/10) of placebo subjects and 77% (22/30) of brodalumab subjects. Three serious AEs were reported in two subjects; there were no opportunistic infections. Brodalumab treatment resulted in inhibition of IL-17 receptor signaling and receptor occupancy on circulating leukocytes. No treatment effects were observed with individual measures of RA disease activity. On day 85 (week 13) 37% (11/30) of brodalumab subjects and 22% (2/9) of placebo subjects achieved ACR20; 7% (2/30) brodalumab subjects and 11% (1/9) of placebo subjects achieved ACR50; and 0% (0/30) brodalumab subjects and 0% (0/9) of placebo subjects achieved ACR70. Conclusions Multiple dose administration of brodalumab was tolerated in subjects with active RA. There was no evidence of a clinical response to brodalumab in subjects with RA. Trial registration ClinicalTrials.gov, NCT00771030 PMID:24286136

  9. MESHING MOLECULAR SEQUENCES AND CLINICAL TRIALS: A FEASIBILITY STUDY

    PubMed Central

    Chen, Elizabeth S.; Sarkar, Indra Neil

    2009-01-01

    The centralized and public availability of molecular sequence and clinical trial data presents an opportunity to identify potentially valuable linkages across the bench-to-bedside “T1” translational barrier. In this study, we sought to leverage keyword metadata (Medical Subject Heading [MeSH] descriptors) to infer relationships between molecular sequences and clinical trials, as indexed by GenBank and ClinicalTrials.gov. The results of this feasibility study found that approximately 30% of sequences in GenBank could be linked to trials and over 90% of trials in ClinicalTrials.gov could be linked to sequences through MeSH descriptors. In a cursory evaluation, we were able to consistently identify meaningful linkages between molecular sequences and clinical trials. Based on our findings, there may be promise in subsequent studies aiming to identify linkages across the T1 translational barrier using existing large repositories. PMID:19850150

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

    ERIC Educational Resources Information Center

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

    2012-01-01

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

  11. [Adaptive clinical study methodologies in drug development].

    PubMed

    Antal, János

    2015-11-29

    The evolution of drug development in human, clinical phase studies triggers the overview of those technologies and procedures which are labelled as adaptive clinical trials. The most relevant procedural and operational aspects will be discussed in this overview from points of view of clinico-methodological aspect.

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

    PubMed

    Lomboy, Jason R; Coward, Robert M

    2016-09-01

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

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

    PubMed

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

    2014-07-01

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

  14. Treatment of Onychomycosis – a Clinical Study

    PubMed Central

    Pajaziti, Laura; Vasili, Ermira

    2015-01-01

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

  15. The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

    PubMed Central

    2013-01-01

    Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical

  16. [Clinical study for the evaluation of the tolerability of O-(beta-hydroxy-ethyl)-rutoside in the treatment of hemorrhoids during the 3d trimester of pregnancy and in the postpartum period].

    PubMed

    Benzi, G; Vanzulli, A; Pozzi, E; Acerboni, S

    1992-11-01

    Hemorrhoidal disease is particularly frequent in the last trimester of pregnancy and immediately after birth. The aim of the present study was to evaluate the efficacy and tolerability of high doses of O-(beta-hydroxyethyl)-rutoside in patients affected by this pathology. Forty-two women with hemorrhoid varices of varying severity which had appeared during the last trimester of pregnancy or immediately post-partum were treated by administering 3 g/day of the substance in question for 14 consecutive days. At the start and end of treatment a series of clinical and objective parameters were measured and at the end of treatment efficacy and tolerability were assessed. The latter was found to be excellent; in fact, it was not necessary to suspend treatment in any of the subjects treated. Clinical efficacy, assessed by the researcher, was judged to be positive in 95% of cases treated. Clinical improvements in the parameters examined were statistically significant (p < 0.01). The results obtained confirm the value of oral therapy using O-(beta-hydroxyethyl)-rutoside in pregnant or puerperal patients since the preparation was found to be efficacious and easily managed, above all significantly reducing pain, subjectively the most urgent symptom to be treated.

  17. Development of an Evaluative Procedure for Clinical Clerkships.

    ERIC Educational Resources Information Center

    And Others; Pancorbo, Salvador

    1980-01-01

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

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

    ERIC Educational Resources Information Center

    Innovative Programming Systems, Minneapolis, Minn.

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

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

    PubMed Central

    Berger, Vance W.; Alperson, Sunny Y.

    2009-01-01

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

  20. Current status of functional gastrointestinal evaluation in clinical practice

    PubMed Central

    Ang, Daphne; Fock, Kwong Ming; Law, Ngai Moh; Ang, Tiing Leong

    2015-01-01

    Neurogastroenterology and motility disorders of the gastrointestinal (GI) tract encompass a broad spectrum of diseases involving the GI tract and central nervous system. They have varied pathophysiology, clinical presentation and management, and make up a substantial proportion of outpatient clinic visits. Typically, patients experience persistent symptoms referable to the GI tract despite normal endoscopic and radiologic findings. An appropriate evaluation is thus important in the patient’s care. Advances in technology and understanding of the disease pathophysiology have provided better insight into the physiological basis of disease and a more rational approach to patient management. While technological advances serve to explain patients’ persistent symptoms, they should be balanced against the costs of diagnostic tests. This review highlights the GI investigative modalities employed to evaluate patients with persistent GI symptoms in the absence of a structural lesion, with particular emphasis on investigative modalities available locally and the clinical impact of such tools. PMID:25715853

  1. Current status of functional gastrointestinal evaluation in clinical practice.

    PubMed

    Ang, Daphne; Fock, Kwong Ming; Law, Ngai Moh; Ang, Tiing Leong

    2015-02-01

    Neurogastroenterology and motility disorders of the gastrointestinal (GI) tract encompass a broad spectrum of diseases involving the GI tract and central nervous system. They have varied pathophysiology, clinical presentation and management, and make up a substantial proportion of outpatient clinic visits. Typically, patients experience persistent symptoms referable to the GI tract despite normal endoscopic and radiologic findings. An appropriate evaluation is thus important in the patient's care. Advances in technology and understanding of the disease pathophysiology have provided better insight into the physiological basis of disease and a more rational approach to patient management. While technological advances serve to explain patients' persistent symptoms, they should be balanced against the costs of diagnostic tests. This review highlights the GI investigative modalities employed to evaluate patients with persistent GI symptoms in the absence of a structural lesion, with particular emphasis on investigative modalities available locally and the clinical impact of such tools.

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

    ERIC Educational Resources Information Center

    Renshaw, Rebecca L.

    2010-01-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2015-02-01

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

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

    PubMed Central

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

    2014-01-01

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

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

    PubMed

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

    The randomised controlled clinical trial (RCT) is a powerful instrument to evaluate different therapeutic regimens. In a survey among 115 physicians visiting the 25th annual meeting of the Surgical Society of Berlin and Brandenburg, the RCT was judged to be very important when changes of therapeutic strategies are discussed. 90 % of all participants claimed to use data from RCTs in the clinical routine and 89 % would participate in such a trial. In official (e. g. discussions during coffee breaks at scientific meetings) or non-medical (e. g. non-scientific press or media) sources of information were assessed as irrelevant for decisions regarding therapeutic strategies. However, in contrast to this view laparoscopic cholecystectomy was introduced into clinical practice rapidly because patients informed by external (non-medical) sources preferred to be operated on with the "modern" technique. Clinical trials with a high level of evidence had no relevant influence on the rapid distribution of laparoscopic cholecystectomy. Controversial discussions concerning the extent of lymphadenectomy with gastric resection for carcinoma demonstrate that the value of excellent clinical RCTs is low if their results challenge a stable paradigma of the surgical scientific society. To allow a rational judgement, new surgical technologies should undergo a scientific gradual evaluation in agreement with the principles of evidence based medicine. PMID:12085271

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

    PubMed

    Schwenk, W; Haase, O; Müller, J M

    2002-04-01

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

  8. Pathophysiology and clinical evaluation of acute heart failure.

    PubMed

    Mentz, Robert J; O'Connor, Christopher M

    2016-01-01

    Acute heart failure (AHF) is a complex syndrome characterized by worsening heart failure (HF) symptoms that requires escalation of therapy. Intrinsic cardiac abnormalities and comorbid conditions, including lung and renal disease, and sleep-disordered breathing, can contribute to the development of AHF. In this Review, we summarize and discuss the literature on the clinical evaluation and underlying pathophysiology of AHF. Important features of AHF evaluation include identification of precipitating factors to the disease, and assessment of circulatory-renal limitations associated with use of HF medications, prior HF hospitalizations, congestion and perfusion profiles, and end-organ dysfunction. The pathophysiological contributions of endothelial dysfunction, neurohormonal activation, venous congestion, and myocardial injury to the development of AHF are also discussed. These potential causative mechanisms provide a framework for clinicians to evaluate and manage patients with AHF and highlight possible future targets for therapies designed to improve clinical outcomes.

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

    PubMed

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

    2012-10-01

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

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

    PubMed Central

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

    2012-01-01

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

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

    ERIC Educational Resources Information Center

    Swanke, Jayme; Zeman, Laura Dreuth

    2015-01-01

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

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

    PubMed

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

    2016-09-19

    Purpose The purpose of this paper is to present lessons learnt through the development of an evaluation framework for a clinical redesign programme - the aim of which was to improve the patient journey through improved discharge practices within an Australian public hospital. Design/methodology/approach The development of the evaluation framework involved three stages - namely, the analysis of secondary data relating to the discharge planning pathway; the analysis of primary data including field-notes and interview transcripts on hospital processes; and the triangulation of these data sets to devise the framework. The evaluation framework ensured that resource use, process management, patient satisfaction, and staff well-being and productivity were each connected with measures, targets, and the aim of clinical redesign programme. Findings The application of business process management and a balanced scorecard enabled a different way of framing the evaluation, ensuring measurable outcomes were connected to inputs and outputs. Lessons learnt include: first, the importance of mixed-methods research to devise the framework and evaluate the redesigned processes; second, the need for appropriate tools and resources to adequately capture change across the different domains of the redesign programme; and third, the value of developing and applying an evaluative framework progressively. Research limitations/implications The evaluation framework is limited by its retrospective application to a clinical process redesign programme. Originality/value This research supports benchmarking with national and international practices in relation to best practice healthcare redesign processes. Additionally, it provides a theoretical contribution on evaluating health services improvement and redesign initiatives. PMID:27681027

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

    PubMed

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

    2016-09-19

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

  14. Best practices for clinical pathology testing in carcinogenicity studies.

    PubMed

    Young, Jamie K; Hall, Robert L; O'Brien, Peter; Strauss, Volker; Vahle, John L

    2011-02-01

    The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.

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

    PubMed

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

    2016-06-01

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

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

    PubMed Central

    2016-01-01

    Introduction Peri-implant tissue health is a requisite for success of dental implant therapy. Plaque accumulation leads to initiation of gingivitis around natural teeth and peri-implantitis around dental implants. Peri-implantitis around dental implants may result in implant placement failure. For obtaining long-term success, timely assessment of dental implant site is mandatory. Aim To assess and evaluate Quality of Life (OHRQoL) of individuals with dental implants using the Oral Health Impact Profile (OHIP-14). Materials and Methods Total 92 patients were evaluated for assessment of the health of peri-implant tissues by recording, Plaque Index (PI), Probing Pocket Depth (PD), Bleeding On Probing (BOP) and Probing Attachment Level (PAL) as compared to contra-lateral natural teeth (control). In the same patients Quality of Life Assessment was done by utilizing Oral Health Impact Profile Index (OHIP-14). Results The mean plaque index around natural teeth was more compared to implants and it was statistically significant. Other three dimensions mean bleeding on probing; mean probing attachment level and mean pocket depth around both natural teeth and implant surfaces was found to be not statistically significant. OHIP-14 revealed that patients with dental implants were satisfied with their Oral Health-Related Quality of Life (OHRQoL). Conclusion Similar inflammatory conditions are present around both natural teeth and implant prostheses as suggested by results of mean plaque index, mean bleeding on probing, mean pocket depth and mean probing attachment level, hence reinforcing the periodontal health maintenance both prior to and after incorporation of dental implants. Influence of implant prostheses on patient’s oral health related quality of life (as depicted by OHIP-14) and patients’ perceptions and expectations may guide the clinician in providing the best implant services. PMID:27190953

  17. A measure to evaluate deformable registration fields in clinical settings.

    PubMed

    Schreibmann, Eduard; Pantalone, Paul; Waller, Anthony; Fox, Tim

    2012-01-01

    Deformable registration has migrated from a research topic to a widely used clinical tool that can improve radiotherapeutic treatment accuracy by tracking anatomical changes. Although various mathematical formulations have been reported in the literature and implemented in commercial software, we lack a straightforward method to verify a given solution in routine clinical use. We propose a metric using concepts derived from vector analysis that complements the standard evaluation tools to identify unrealistic wrappings in a displacement field. At the heart of the proposed procedure is identification of vortexes in the displacement field that do not correspond to underlying anatomical changes. Vortexes are detected and their intensity quantified using the CURL operator and presented as a vortex map overlaid on the original anatomy for rapid identification of problematic regions. We show application of the proposed metric on clinical scenarios of adaptive radiotherapy and treatment response assessment, where the CURL operator quantitatively detected errors in the displacement field and identified problematic regions that were invisible to classical voxel-based evaluation methods. Unrealistic warping not visible to standard voxel-based solution assessment can produce erroneous results when the deformable solution is applied on a secondary dataset, such as dose matrix in adaptive therapy or PET data for treatment response assessment. The proposed metric for evaluating deformable registration provides increased usability and accuracy of detecting unrealistic deformable registration solutions when compared to standard intensity-based approaches. It is computationally efficient and provides a valuable platform for the clinical acceptance of image-guided radiotherapy. PMID:22955647

  18. A laboratory and clinical evaluation of three dental luting cements.

    PubMed

    Knibbs, P J; Walls, A W

    1989-09-01

    The loss of material from specimens of three luting cements was measured after continuous erosion cycling in the laboratory. The glass ionomer luting cement showed significantly less material loss than the zinc polycarboxylate and zinc phosphate luting cements. Two hundred and fifty restorations cemented with one of the three materials were studied clinically for marginal integrity and retention over 3.5 years. The data were tested using survival analysis. Zinc phosphate cement gave the best clinical performance. Possible explanations for the poor correlation between the findings in the laboratory and clinical study are discussed.

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

    PubMed

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

    2016-04-21

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

  20. Economic evaluation in long-term clinical trials.

    PubMed

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

    2002-10-15

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

  1. Economic evaluation in long-term clinical trials.

    PubMed

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

    2002-10-15

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

  2. Clinical use of noninvasive evaluation of the carotid artery.

    PubMed

    Persson, A V; O'Leary, D H; Kovacs, A; Dyer, V E

    1980-06-01

    The noninvasive evaluation of carotid artery disease should include a battery of tests that includes one direct and one indirect assessment of the extracranial carotid arteries. The resulting data should be correlated with the clinical findings and the patient's general status so the risks and benefits of carotid endarterectomy may be determined. These studies are usually outpatient procedures and allow one to determine in the office which patients would benefit from carotid surgery and who should be followed serially. Carotid arteriography is reserved for those patients who will be subjected to surgery. In our hands, the combination of CPA, Kartchner-McRae OPG, and Echoflow fulfill these requirements. In a small number of patients the history, physical examination, and noninvasive studies are inconclusive. For most patients, we are able to make decisions as to the best therapy in the office and can discuss risks and benefits with patients and their families with an accuracy of approximately 95 per cent before hospitalization and arteriography are considered.

  3. Several strategies for evaluating the objectivity of measurements in clinical research and practice

    PubMed Central

    Keating, Joseph C

    1988-01-01

    The objectivity (interexaminer reliability) of measurement in chiropractic provides a basis for judging the quality of information in clinical research and practice. Objectivity may be determined by formal measurement evaluation studies and by sampling within clinical trials. Interpretation of inter-examiner reliability requires descriptive and inferential statistics selected on the basis of the mathematical properties of data, appreciation of the clinical meaning of a particular measure, and recognition of the role of chance. Methods of data analysis include scatter-plots, contingency tables, time-series graphs, and correlational and concordance coefficients. Many kinds of objectivity evaluations are well within the capacities of private practitioners and student clinicians.

  4. [Clinical effectiveness and economical evaluation of preventive vaccination].

    PubMed

    Vaz Carneiro, António; Belo, Ana Isabel; Gouveia, Miguel; Costa, João; Borges, Margarida

    2011-01-01

    The value of mass vaccination as a preventive measure for infectious diseases is one of the most important advances of modern Medicine. The impact on incidence of several infectious diseases, until recently responsible for significant morbidity and mortality at world level, is well proved in a series of high quality epidemiological studies. In this scientific review we aimed firstly to briefly resume the history of mass vaccination and its scientists, responsible for synthesis and marketing of these drugs. In second place we present a group of a few disease preventable by vaccines as well as the Portuguese National Vaccination Plan and its benefits. In third place we identified groups of subjects in which a well structured vaccination plan is particularly important, as well as the correspondent diseases to be covered by vaccination. Fourthly, we discussed the ethical considerations of vaccination, and its tensions between subject autonomy and society advantages in com pulsive programs. Fifthly, we analyzed clinical effectiveness of vaccines through the concept of herd immunity, clinical evaluation of immune response to vaccines and some examples of systematic reviews on three relevant diseases (influenza, meningococcal and pneumococcal infections). In sixth place we discussed vaccine safety presenting monitoring methods of vaccination risks, as well as discussing the public myths concerning vaccines. Finally we present a economic analysis of preventive vaccination with a review of some published literature on specific diseases. We conclude that mass vaccination is a efficacious preventive measure, as well as a economic rational choice, and that this public health intervention should be a pillar of a modern preventive system.

  5. Laser resistant stainless steel endotracheal tube: experimental and clinical evaluation.

    PubMed

    Fried, M P; Mallampati, S R; Liu, F C; Kaplan, S; Caminear, D S; Samonte, B R

    1991-01-01

    A fire due to endotracheal tube (ET) ignition is a catastrophic event that may occur during laser surgery of the upper airway, regardless of the wavelength utilized. Although methods exist that permit laser surgery without an ET, this is frequently not feasible. The current investigation was undertaken to evaluate the efficacy of a double-cuffed stainless steel ET, first in the laboratory and subsequently in a clinical setting. Bench testing was performed using CO2 (both standard and milliwatt) and KTP/532 lasers. Only the distal polyvinyl chloride cuffed end of the tube was potentially ignitable, however, the appropriate use of saline to fill the cuffs allowed only for cuff perforation without ignition. Canine testing was performed in 10 animals: 4 dogs were intubated from 3 to 4.5 hours with the laser resistant stainless steel endotracheal tube (LRSS-ET) (Laser-Flex Tracheal Tube; Mallinckrodt Anesthesia Products, St. Louis, MO) and 2 with an aluminum tape wrapped red rubber ET. Visual and histological examination were performed in both groups at 3 and 7 days. Four dogs underwent CO2 laser laryngeal surgery with visual and histological examination performed at 7 days postoperatively. No untoward effects could be demonstrated due to the LRSS-ET. A clinical study was then performed in 24 patients who underwent laser surgery of the upper aerodigestive tract with either a CO2 or KTP/532 laser. In all cases ventilation was adequate, the shaft of the LRSS-ET proved impervious to the laser, and the distal end of the tube protected the tracheobronchial tree safely.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:1861569

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

    PubMed

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

    2016-10-01

    Diabetic polyneuropathy (DPN) is a major cause of neuropathic pain and a frequent target condition in analgesic treatment trials. Differences in the clinical symptoms and signs associated with DPN suggest distinct pathophysiological mechanisms underlying nerve damage and dysfunction that are likely to have therapeutic relevance. The aim of this study was to develop a tool for the bedside assessment of painful neuropathies such as DPN that captures the diversity of phenotypes. Sixty-one patients with type 2 diabetes and painful neuropathy, 19 patients with painless DPN, 25 patients with type 2 diabetes but no clinical evidence of neuropathy, and 20 healthy control subjects completed a structured interview (47 items) and a standardized physical examination (39 items). After analyzing critical features of pain and painless symptoms and examining the outcome of physical tests of sensory function, we determined principal components of the phenotypic variance among patients. Increased sensitivity to mechanical or thermal stimuli and, to a lesser extent, the sensory quality of pain or paresthesia were the most discriminating elements of DPN phenotypes. Correlation patterns of symptoms and signs indicated the involvement of functionally distinct nerve fiber populations. We combined interview questions and physical tests identifying these differences in a shortened assessment protocol that we named Standardized Evaluation of Pain and Somatosensory Function (StEPS). The protocol StEPS generates a phenotypic profile of patients with neuropathy. Separate intensity ratings for spontaneous painful symptoms and pain evoked by standard stimuli support a detailed documentation of neuropathic pain and its response to analgesic treatment. PMID:27322439

  7. Severely dry skin: clinical evaluation of a highly effective therapeutic lotion.

    PubMed

    Kantor, I; Ballinger, W G; Savin, R C

    1982-09-01

    Four clinical studies are presented on a recently introduced therapeutic lotion for severely dry skin. Two monadic single-blind efficacy studies showed that hands of subjects treated with the product (Lotion V) were significantly improved over untreated hands. Following the completion of a regression study, two subsequent double-blind comparative studies showed Lotion V to be significantly more effective than a well-established therapeutic lotion (Lotion K) for certain major signs and symptoms of dry skin. Results were derived from both objective clinical evaluation by investigating dermatologists and subjective evaluation by participating volunteers.

  8. [Study on the clinical evaluation of DHAS loading as a fetoplacental function test--effect of DHAS on estrogen metabolism at a fetoplacental unit].

    PubMed

    Kiriyama, T

    1986-05-01

    To evaluate estrogen metabolism in the fetoplacental unit after dehydroepiandrosterone-sulfate (DHAS) injection to the mother, unconjugated estrone, estradiol, estriol and estetrol in maternal vein (MV), umbilical vein (UV), umbilical artery (UA) and amniotic fluid (AF) were measured after DHAS injection. Eighteen normal obstetric patients (37-39W) on whom was performed elective repeat cesarean section were injected with 100 mg of DHAS 30-60 minutes (7 cases), 120 minutes (6 cases), 180-240 minutes (5 cases) before delivery. The injection of DHAS to the mother resulted in a rapid marked rise in estradiol levels in MV (400% of control) and estrone levels in UV (1480% of control). The rise in estrone levels in MV was slower than that of estradiol. The increase in estradiol in UV and UA was significant, but the values were lower than that in MV. No significant changes in estriol levels in each compartment were demonstrated. However, a significant increase in estetrol was observed in each compartment by 4 hours. A significant correlation was found between individual MV and UV plasma estetrol concentrations. These results indicate that placenta secretes estrone and estradiol asymmetrically to maternal and fetal circulation after DHAS injection. Determination of the maternal estradiol and estetrol rise after DHAS injection may reflect placental and fetoplacental function, but estriol may not. PMID:2941503

  9. Uremic pruritus. Clinical and experimental studies.

    PubMed

    Ståhle-Bäckdahl, M

    1989-01-01

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

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

    PubMed

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

    2007-01-01

    Radiation-induced xerostomia can result in the rapid onset and progression of dental caries in head and neck cancer patients. Topically applied fluorides have been successfully used to inhibit the formation of dental caries in this population. However, because intensive daily self-application is required, compliance is an issue. The intraoral fluoride-releasing system (IFRS) containing a sodium fluoride core is a newly developed, sustained-release, passive drug delivery system that does not require patient involvement except for periodic replacement, thus reducing the effect of patient compliance on its effectiveness in dental caries prevention. Twenty-two head and neck cancer patients from U. T. M. D. Anderson Cancer Center, with radiation-induced xerostomia, were entered into a pilot study to contrast the daily home use of a 0.4% stannous fluoride-gel-containing tray (control group) to IFRS (study group) with respect to tolerability and adherence, and to obtain information on relative caries preventive efficacy. Participants were stratified on the basis of radiation exposure and randomly assigned to treatment with either IFRS or stannous fluoride gel. Patients in both groups were fitted with two IFRS retainers and also were instructed to use a 1100-ppm fluoride conventional sodium fluoride dentifrice twice daily. The study was conducted as a single-blinded, parallel-cell trial. Pre-existing carious lesions were restored prior to the beginning of the study. The efficacy variable was determined by the mean number of new or recurrent decayed surfaces. Patients were examined for caries 4, 8, 12, 24, 36, and 48 weeks after initiation of treatment. Reports of adverse reactions were based on information volunteered by patients and that were elicited during interviews. At baseline, the resting and stimulated salivary flow rates (g/5min) were significantly greater in the control group than in the study group (p<0.05). Patients in the control group had received

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

    ERIC Educational Resources Information Center

    Bordage, Georges

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

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

    ERIC Educational Resources Information Center

    Fish, Caroline; And Others

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

  13. A clinical study evaluating dendritic and cytokine-induced killer cells combined with concurrent radiochemotherapy for stage IIIB non-small cell lung cancer.

    PubMed

    Zhu, X P; Xu, Y H; Zhou, J; Pan, X F

    2015-08-28

    To compare the efficacy of dendritic and cytokine-induced killer cells (DC-CIK) therapy combined with concurrent radiochemotherapy on stage IIIB non-small cell lung cancer. Sixty-three patients with stage IIIB non-small cell lung cancer were randomly divided into the study and control groups. The study group, comprising 30 patients, was treated with DC-CIK combined with docetaxel-cisplatin chemotherapy and synchronization conformal radiotherapy. The control group including 33 patients was only treated with docetaxel-cisplatin chemotherapy and synchronization conformal radiotherapy. The efficacy, Karnofsky performance score (KPS), tumor markers, 6-month and 12-month survival rate, T cell subsets, and adverse reactions of the two groups were compared. The response rate of the study group was 83.3% (25/30), and that of the control group was only 54.5% (18/33). Furthermore, the KPS, T cell subsets, and 12-month survival rate was significantly higher in the study group, and there were significant differences between the two groups. The two groups had no significant difference in adverse reactions. The combined DC-CIK therapy, with synchronous radiotherapy and chemotherapy to treat stage IIIB non-small cell lung cancer was superior to single synchronous radiotherapy and chemotherapy. The combined therapy can improve the life quality and prolong the survival time of the patients.

  14. Tuberculosis care: an evaluability study

    PubMed Central

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

    2014-01-01

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

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

    PubMed Central

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

    2014-01-01

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

  16. [Organization, administration, and performance of clinical studies].

    PubMed

    Bachner, Mark; Steininger, Tanja; Gneist, Margit

    2008-01-01

    This contribution deals with all important organizational and administrative aspects of clinical studies in German speaking countries. All trials are to be executed in accordance with the Good Clinical Practice (GCP) Guidelines. GCP applies to the process of designing, conducting, recording, and reporting of clinical studies. Compliance with GCP facilitates the mutual acceptance of resulting clinical data by the respective regulatory authorities worldwide. Before initiating a clinical study the investigator has to obtain written and dated approval from the responsible ethics committee, the competent authorities, and the hospital administration. The investigator's study file contains all essential study documents. One of the most important tasks of an investigator is to properly inform the prospective subjects and to obtain their informed consent. All relevant treatment-related information has to be recorded in the patient files. These source data are transferred to case report forms. During monitoring visits, audits, and inspections, source data verification will be performed routinely. Any adverse events (AEs) must be documented according to the CTCAE, the Common Terminology Criteria for Adverse Events. All serious adverse events (SAEs) have to be reported to the sponsor immediately. At the end of the study a termination visit is performed, and all authorities are officially informed about the termination of the trial.

  17. Clinical evaluation of the failure rates of metallic brackets

    PubMed Central

    ROMANO, Fábio Lourenço; CORRER, Américo Bortolazzo; CORRER-SOBRINHO, Lourenço; MAGNANI, Maria Beatriz Borges de Araújo; RUELLAS, Antônio Carlos de Oliveira

    2012-01-01

    Objectives The aim of this study was to evaluate in vivo the bonding of metallic orthodontic brackets with different adhesive systems. Material and Methods Twenty patients (10.5-15.1 years old) who had sought corrective orthodontic treatment at a University Orthodontic Clinic were evaluated. Brackets were bonded from the right second premolar to the left second premolar in the upper and lower arches using: Orthodontic Concise, conventional Transbond XT, Transbond XT without primer, and Transbond XT associated with Transbond Plus Self-etching Primer (TPSEP). The 4 adhesive systems were used in all patients using a split-mouth design; each adhesive system was used in one quadrant of each dental arch, so that each group of 5 patients received the same bonding sequence. Initial archwires were inserted 1 week after bracket bonding. The number of bracket failures for each adhesive system was quantified over a 6-month period. Results The number of debonded brackets was: 8- Orthodontic Concise, 2- conventional Transbond XT, 9- Transbond XT without primer, and 1- Transbond XT + TPSEP. By using the Kaplan-Meier methods, statistically significant differences were found between the materials (p=0.0198), and the Logrank test identified these differences. Conventional Transbond XT and Transbond XT + TPSEP adhesive systems were statistically superior to Orthodontic Concise and Transbond XT without primer (p<0.05). There was no statistically significant difference between the dental arches (upper and lower), between the dental arch sides (right and left), and among the quadrants. Conclusions The largest number of bracket failures occurred with Orthodontic Concise and Transbond XT without primer systems and few bracket failures occurred with conventional Transbond XT and Transbond XT+TPSEP. More bracket failures were observed in the posterior region compared with the anterior region. PMID:22666842

  18. Primitive reflex evaluation in the clinical assessment of extrapyramidal syndromes.

    PubMed

    Borroni, B; Broli, M; Costanzi, C; Gipponi, S; Gilberti, N; Agosti, C; Padovani, A

    2006-09-01

    The aim of the present study was to evaluate the role of primitive reflexes (PRs) as additional alert sign in routine clinical practice in patients with extrapyramidal syndrome. We considered glabellar, snout, palmomental and grasp reflexes in patients with mild stage of Lewy body dementia (LBD), corticobasal degeneration, progressive supranuclear palsy or Parkinson disease (PD). We also enrolled mild Alzheimer disease (AD) patients, and healthy subjects, as controls. LBD patients showed the highest prevalence of PRs compared with the other groups. The odds ratio of the risk of LBD in PRs > or = 2 was 27.9 (95% CI 2.9-269.0) compared with control group, 14.6 (95% CI 2.7-79.6) compared with mild AD, and 19.7 (95% CI 3.7-104.3) compared with PD. These data suggest that the occurrence of combination of PRs might be an useful additional warning sign of possible diffuse Lewy body pathology more than other causes of extrapyramidal syndrome.

  19. European multicentre evaluation of the ABBOTT Spectrum clinical chemistry analyzer.

    PubMed

    Blijenberg, B G; Braconnier, F; Vallez, J M; Burlina, A; Plebani, M; Celadin, M; Haeckel, R; Römer, M; Hänseler, E; De Schrijver, G

    1989-06-01

    The analytical performance of the selective multitest ABBOTT Spectrum analyser was studied according to the ECCLS guidelines and partly the CERMAB protocol in a multicentre evaluation involving laboratories from six European countries. Fifteen analytes, including the electrolytes sodium, potassium and chloride, were measured each in at least 3 laboratories, all at 37 degrees C, except the electrolytes, which are measured at room temperature. The trial lasted approximately three months and involved the collection of over 60,000 data points. It yielded the following results: 1. The precision was at least as good as the precision obtained with the comparison instruments. The majority of the coefficients of variation were between 1 and 4%. 2. The recovery for method assigned control sera values was, with few exceptions, within 10%. 3. Good agreement with respect to the method assigned values of control materials and method comparison with patient specimens to different instruments (e.g. SMAC, Hitachi 737, RA 1000) was found. 4. No drift was observed. 5. Reagent-related carry-over was not found. Specimen-related carry-over was detected in some cases, the deviation being of little or no clinical significance. 6. The manufacturer's claims regarding method linearity were as stated or exceeded. 7. The open system capability was tested and rated as very convenient. 8. The practicability of the instrument was very good.

  20. Clinical evaluation of therapeutic success in rabbits with suspected encephalitozoonosis.

    PubMed

    Sieg, Jessica; Hein, Jutta; Jass, Ariane; Sauter-Louis, Carola; Hartmann, Katrin; Fischer, Andrea

    2012-06-01

    Between 2000 and 2008, 95 rabbits with suspected encephalitozoonosis and neurological symptoms were treated at the Clinic of Small Animal Medicine, Ludwig Maximilian University Munich. Standard treatment consisted of oxytetracycline (from 2000 to 2003; n=50) or fenbendazole and oxytetracycline (from 2004 to 2008; n=45), and the rabbits were randomly assigned to treatment groups with or without dexamethasone. Each therapeutic regime was given for 10 days, with fluids, B vitamins and nutritional support added as needed. Therapeutic success was evaluated by assessing the survival rate on day 10, the neurological score of the surviving rabbits and Kaplan-Meier curves for long-term survival past 10 days. Inclusion of fenbendazole in the treatment protocol was associated with increased survival rates on day 10 (p=0.043), better neurological scores (p=0.008), and improved long-term survival (p=0.025) based on the results of univariate analyses. Treatment with dexamethasone showed no effect on neurological score or on short- or long-term survival. The study did not provide any evidence that dexamethasone is an effective component of the treatment scheme.

  1. Clinical Evaluation of Shilajatu Rasayana in patients with HIV Infection

    PubMed Central

    Gupta, G. D.; Sujatha, N.; Dhanik, Ajay; Rai, N. P.

    2010-01-01

    AIDS is one of the serious global health concerns caused by Human Immuno Deficiency(HIV) virus and is predominantly a sexually transmitted disease. Currently there is no vaccine or cure for AIDS still Anti Retroviral Therapy (ART) is successful. It reduces both the mortality and the morbidity of HIV infection, but is expensive and inaccessible in many countries. However intense the therapy may be, HIV virus is rarely eliminated, and drug resistance is a major setback during long-term therapy. The development of new drugs and strategies and exploring alternative systems of medicine for antiviral herbs or drugs is the need of the age to improve treatment outcomes. Ayurveda describes many diseases which incorporate HIV like illness e.g. Rajayakshma, Ojo Kshaya, Sannipata jwara etc. HIV infection affects multisystems, chiefly the Immune System which can be correlated to Ojo Kshaya. Rasayana Chikitsa is the frontline therapy employed to treat Ojus disorders. Therefore Shilajatu (Mineral pitch), Centella asiatica (Mandukaparni), Tinospora cordifolia (Guduchi) and Emblica officinalis (Amalaki), well known for their Immuno-modulator and antioxidant properties were selected to evaluate their role on immune system. The study was carried on 20 patients from OPD and IPD of Kayachikitsa, S.S.Hospital, IMS, BHU and was randomly allocated into Treated group (Shilajatu+ART) and Control group (ART). Treated Group responded better to ART both clinically and biochemically. The results show that Shilajatu decreases the recurrent resistance of HIV virus to ART and improves the outcome of the therapy PMID:22131681

  2. Clinical evaluations of mineralized collagen in the extraction sites preservation

    PubMed Central

    Feng, Lu; Zhang, Liang; Cui, Yun; Song, Tian-Xi; Qiu, Zhi-Ye; Wang, Xiu-Mei; Tan, Bao-Sheng

    2016-01-01

    The purpose of this study was to explore the different effects between biomimetic mineralized collagen (MC) and ordinary physically blended hydroxyapatite/collagen (HA/Col) composite in evaluating new bone formation and regenerated bone height in human extraction sockets. Thirty-four patients who cannot retain teeth caused by trauma or decay were randomly selected from Department of Stomatology of Dongzhimen Hospital from December 2013 to December 2014. The patients were randomly divided into two groups. After the operation of tooth extraction, 17 patients were implanted with biomimetic MC (MC group), and other 17 patients were implanted with ordinary physically blended nHA/Col composite (nHA/Col group). X-ray positioning projection by auto-photographing was taken to test the distance between the lowest position and the neighboring CEJm-CEJd immediately, 1 month and 3 months after the operation. The height of new bone formation of the MC group was significantly higher than the nHA/Col group. Biomimetic MC showed better clinical outcomes in the bone formation for extraction site preservation and would have broad application prospect in the field of oral and maxillofacial surgeries. PMID:26815224

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

    PubMed

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

    1994-09-01

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

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

    PubMed

    Lévesque, Martine; Levine, Alissa; Bedos, Christophe

    2016-01-01

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

  5. Clinical study on evaluation of anti-cataract effect of Triphaladi Ghana Vati and Elaneer Kuzhambu Anjana in Timira (immature cataract)

    PubMed Central

    Bhati, Hitesh; Manjusha, R.

    2015-01-01

    Introduction: Senile cataract is the leading cause of blindness according to the World Health Report, 1998. Till date no accepted medical treatment is available for cataract. In Ayurveda visual disturbances are described in the context of Timira, Kacha and Linganasha. Timira is an early stage characterized by blurring of vision and Linganasha is end stage where complete loss of vision occurs. Ancient scholars have advocated different Anjana application and oral medications in the Timira and Kacha stage. Aim: To study the efficacy of test drugs Triphaladi Ghana Vati and Elaneer Kuzhambu Anjana in immature cataract. Materials and Methods: In this trial patients having Senile Immature Cataract were randomized with equal probability to one of the two treatment Groups A and B (n = 20 each). In Group A Triphaladi Ghana Vati 500 mg internally for 3 months and in Group B Triphaladi Ghana Vati 500 mg internally and Elaneer Kuzhambu Anjana for local application were given. Assessment was done on the basis of blurring of vision, visualization of nonexisting things, difficulty in bright light and dim light or night vision, distant visual acuity, pinhole vision, best corrected visual acuity and cataract grading on slit lamp. Results: Both groups showed statistically significant changes in blurring of vision, difficulty in glare, daytime and bright light, distant visual activity, pinhole vision, and best-corrected visual acuity. Group B also showed significant changes in difficulty in night time, visualization of nonexisting things and in nuclear cataract. Conclusion: The study establishes that test drugs can reduce and control the progress of immature cataract, and combined therapy was found more effective. Chakshushya Rasayana, early diagnosis and proper management on Doshic lines can prevent arrest or delay senile cataract. PMID:27313415

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

    PubMed Central

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

    2015-01-01

    Objectives Gingival bleeding following twice-daily use of 0.2% w/v chlorhexidine digluconate mouthrinse with and without alcohol (0.2% CHX-alcohol; 0.2% CHX-alcohol-free, respectively) and brushing with a standard fluoride toothpaste was compared to brushing alone. Methods Three hundred and nineteen subjects with mild-to-moderate gingivitis (with ≥16 gradable permanent teeth including four molars, bleeding after brushing and ≥20 bleeding sites) completed this randomised, examiner-blinded, parallel-group study. A prophylaxis was performed at baseline. Gingival Severity Index (GSI; primary objective), Gingival Index (GI) and Plaque Index (PI) were assessed at baseline and after 6 weeks of treatment. Adverse events (AEs) were recorded throughout the study. Results Between treatment differences at week 6 demonstrated significantly lower GSI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (primary endpoint; treatment difference −0.061 [95% CI −0.081, −0.041] and −0.070 [95% CI −0.090, −0.050], respectively; both p <0.0001). There were also significant reductions in GI and PI for the 0.2% CHX-alcohol and 0.2% CHX-alcohol-free groups compared to brushing alone (all p <0.0001). The proportion of subjects reporting ≥1 treatment-related adverse events (TRAEs) was 27.8% (0.2% CHX-alcohol), 24.8% (0.2% CHX-alcohol-free) and 3.7% (brushing alone). Conclusions Chlorhexidine mouthrinse with or without alcohol as an adjunct to brushing with regular fluoride toothpaste significantly reduces bleeding scores, plaque and gingival inflammation compared to brushing alone. TRAEs are characteristic of those associated with the use of chlorhexidine and are similar for both mouthrinses. PMID:26271869

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

    PubMed

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

    2015-01-01

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

  8. Comparative evaluation of a dentifrice containing calcium sodium phosphosilicate to a dentifrice containing potassium nitrate for dentinal hypersensitivity: A clinical study

    PubMed Central

    Satyapal, Tanya; Mali, Rohini; Mali, Amita; Patil, Vishakha

    2014-01-01

    Background: Calcium sodium phosphosilicate is a recently introduced desensitizing agent which acts by occluding the dentinal tubules and also resists acid decalcification. This study was designed to assess the efficacy of a new toothpaste containing 5% calcium sodium phosphosilicate for the treatment of dentinal hypersensitivity and also compare it with 5% potassium nitrate. Materials and Methods: Sixty patients with the chief complaint of dentinal hypersensitivity were enrolled and randomly divided into two groups. The visual analog scale (VAS) scores were taken for water and air stimuli at baseline, 3 weeks after usage of the respective toothpaste, and 3 weeks after discontinuation of the respective toothpaste. Results: Both the groups showed reduction in hypersensitivity scores at 3 weeks and 6 weeks for air stimulus and cold water. The calcium sodium phosphosilicate group, however, showed significantly reduction in hypersensitivity compared to the potassium nitrate group at any time point for both measures of hypersensitivity. Conclusion: The 5% calcium sodium phosphosilicate group showed immense reduction in dentinal hypersensitivity symptoms. The 5% calcium sodium phosphosilicate showed prolonged effects even after discontinuation as compared to 5% potassium nitrate, due to its dentinal tubular occlusion property. PMID:25425819

  9. Tobacco use and health risks in two dental clinic populations: Implementation and evaluation of a brief targeted intervention.

    PubMed

    Romito, Laura; Budyn, Cynthia; Oklak, Mark A; Gotlib, Josh; Eckert, George J

    2012-01-01

    The present study compared emergency dental clinic and hygiene clinic patients in terms of tobacco use and health risks, and began and evaluated an Ask/Advise/Refer intervention in the emergency clinic. Randomly selected records (N = 820) of patients from both clinics were reviewed and demographics, tobacco, and health data were recorded and analyzed. After a brief training period, student dentists delivered a five-week emergency clinic tobacco intervention and completed a post-intervention evaluation survey. Tobacco use was higher in the emergency clinic and was correlated with systemic and oral disease. Of the 327 emergency clinic patients seen during the pilot study, 50% were smokers, 46% of whom expressed an interested in quitting and 35% of whom obtained cessation referral. Thirty students (86%) completed the evaluation; perceptions of the intervention were neutral to favorable. The emergency clinic Ask/Advise/Refer intervention was well-received by patients and clinicians.

  10. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    PubMed

    Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

    2015-06-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented.

  11. PPB | What is a Clinical Study

    Cancer.gov

    The Pleuropulmonary blastoma (PPB) DICER1 Syndrome Study ‹an observational clinical research study‹is enrolling children with PPB and their families. In an observational study, investigators assess health outcomes in groups of participants according to a protocol or research plan.

  12. Evaluation of psychology practitioner competence in clinical supervision.

    PubMed

    Gonsalvez, Craig J; Crowe, Trevor P

    2014-01-01

    There is a growing consensus favouring the development, advancement, and implementation of a competency-based approach for psychology training and supervision. There is wide recognition that skills, attitude-values, and relationship competencies are as critical to a psychologist's competence as are knowledge capabilities, and that these key competencies are best measured during placements, leaving the clinical supervisor in an unparalleled position of advantage to provide formative and summative evaluations on the supervisee's progression towards competence. Paradoxically, a compelling body of literature from across disciplines indicates that supervisor ratings of broad domains of competence are systematically compromised by biases, including leniency error and halo effect. The current paper highlights key issues affecting summative competency evaluations by supervisors: what competencies should be evaluated, who should conduct the evaluation, how (tools) and when evaluations should be conducted, and process variables that affect evaluation. The article concludes by providing research recommendations to underpin and promote future progress and by offering practice recommendations to facilitate a more credible and meaningful evaluation of competence and competencies.

  13. The Madison Clinic: Evaluation of a collaborative outpatient paediatric palliative care clinic

    PubMed Central

    Siden, Harold; Straatman, Lynn; Miller, Tanice; Ham, Jennifer

    2009-01-01

    BACKGROUND A multidisciplinary outpatient clinic at a tertiary care children’s hospital supported and staffed by a children’s hospice was created to enhance and expand the inpatient palliative care services available to families of children with life-limiting conditions. This clinic was created with input from clinicians, program leaders and families in developing the goals and format. METHOD The clinic was evaluated with indicators that included program data from palliative care consultations. This information was collected and recorded on a prospective basis. RESULTS In the first 29 months of operation, 43 clinics were held, 39 individual patients were seen and there were 59 visits. The majority of visits were for pain and symptom management (75%), while 20% were for assessment for the hospice program. The hospice-palliative care team also provided telephone support, videoconference support and inpatient consultations. Patients reported overall satisfaction with their experiences at the clinic. DISCUSSION A major benefit of this outpatient palliative care clinic is its ability to offer continuity of care for patients and their families. It also serves as a preliminary introduction to palliative care, particularly significant for families who are not yet ready to learn about or engage in the full hospice program. PMID:20592973

  14. Advances in clinical study of curcumin.

    PubMed

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

    2013-01-01

    Curcumin has been estimated as a potential agent for many diseases and attracted great attention owing to its various pharmacological activities, including anti-cancer, and anti-inflammatory. Now curcumin is being applied to a number of patients with breast cancer, rheumatoid arthritis, Alzheimer's disease, colorectal cancer, psoriatic, etc. Several clinical trials have stated that curcumin is safe enough and effective. The objective of this article was to summarize the clinical studies of curcumin, and give a reference for future studies. PMID:23116307

  15. Clinical Evaluation of Efficacy of CIA and CNA Intrusion Arches

    PubMed Central

    Vora, Sambhav; Pandey, Vinisha

    2015-01-01

    Background and Objectives Excessive overbite is one of the most common problems that confront the orthodontist. Deep bite can be due to infraocclusion of posterior teeth, supraocclusion of anterior teeth or a combination of the two. Correction of same can be carried out by extrusion of molars, intrusion of incisors or by a combination of both respectively. Various intrusion arches are recommended for correcting deep bite by true intrusion of anterior teeth, Utility arches, Segmental arch, Connecticut Intrusion Arch (CIA) and Connecticut New Arch (CNA). The purpose of this study was to evaluate clinical efficacy of CIA and CNA intrusion arches. Materials and Methods Tracings recorded from pre and post-treatment lateral cephalograms of 25 patients treated by CIA (Group I) and another 25 patients treated by CNA (Group II) intrusion arches in deep bite cases after four months of treatment were analysed and findings were recorded. Statistical Analysis Paired t-test was used to compare pre and post-treatment changes within Groups I and II and unpaired t-test was used to compare treatment changes between Group I and Group II. A P-value of < 0.05 was set for statistical significance. Results Findings of this study demonstrate that an average of 1mm of intrusion takes place with CIA intrusion arch and 1.3mm with CNA intrusion arch in a period of 4 months. Both intrusion arches do not affect the position of molar in vertical or anteroposterior plane. Interpretation & Conclusion Both CIA and CNA intrusion arches are effective in bringing about intrusion of lower incisors. PMID:26501008

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

    PubMed Central

    Gubanova, Elena I; Starovatova, Polina A

    2015-01-01

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

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

    PubMed

    Wang, Yuanyuan; Day, Roger

    2010-01-01

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

  18. A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

    ERIC Educational Resources Information Center

    Lee, Seon Ah

    2010-01-01

    The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

  19. Agreement between Therapists, Parents, Patients, and Independent Evaluators on Clinical Improvement in Pediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Lewin, Adam B.; Peris, Tara S.; De Nadai, Alessandro S.; McCracken, James T.; Piacentini, John

    2012-01-01

    Objective: Independent evaluators (IE) are used widely in clinical trials to make unbiased determinations of treatment response. By virtue of being kept blind to treatment condition, however, IEs are also kept unaware of many pertinent clinical details that are relevant for decisions about clinical improvement. In this study, agreement among…

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

    PubMed

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

    1988-04-01

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

  1. Design and evaluation of a bacterial clinical infectious diseases ontology.

    PubMed

    Gordon, Claire L; Pouch, Stephanie; Cowell, Lindsay G; Boland, Mary Regina; Platt, Heather L; Goldfain, Albert; Weng, Chunhua

    2013-01-01

    With antimicrobial resistance increasing worldwide, there is a great need to use automated antimicrobial decision support systems (ADSSs) to lower antimicrobial resistance rates by promoting appropriate antimicrobial use. However, they are infrequently used mostly because of their poor interoperability with different health information technologies. Ontologies can augment portable ADSSs by providing an explicit knowledge representation for biomedical entities and their relationships, helping to standardize and integrate heterogeneous data resources. We developed a bacterial clinical infectious diseases ontology (BCIDO) using Protégé-OWL. BCIDO defines a controlled terminology for clinical infectious diseases along with domain knowledge commonly used in hospital settings for clinical infectious disease treatment decision-making. BCIDO has 599 classes and 2355 object properties. Terms were imported from or mapped to Systematized Nomenclature of Medicine, Unified Medical Language System, RxNorm and National Center for Bitechnology Information Organismal Classification where possible. Domain expert evaluation using the "laddering" technique, ontology visualization, and clinical notes and scenarios, confirmed the correctness and potential usefulness of BCIDO. PMID:24551353

  2. Achieving Cannabis Cessation - Evaluating N-acetylcysteine Treatment (ACCENT): Design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network

    PubMed Central

    McClure, Erin A.; Sonne, Susan C.; Winhusen, Theresa; Carroll, Kathleen M.; Ghitza, Udi E.; McRae-Clark, Aimee L.; Matthews, Abigail G.; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G.; Levin, Frances R.; Weiss, Roger D.; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J.; Haynes, Louise; Brigham, Gregory S.; Sparenborg, Steve; Hasson, Albert L.; Gray, Kevin M.

    2014-01-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18–50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders. PMID:25179587

  3. Achieving cannabis cessation -- evaluating N-acetylcysteine treatment (ACCENT): design and implementation of a multi-site, randomized controlled study in the National Institute on Drug Abuse Clinical Trials Network.

    PubMed

    McClure, Erin A; Sonne, Susan C; Winhusen, Theresa; Carroll, Kathleen M; Ghitza, Udi E; McRae-Clark, Aimee L; Matthews, Abigail G; Sharma, Gaurav; Van Veldhuisen, Paul; Vandrey, Ryan G; Levin, Frances R; Weiss, Roger D; Lindblad, Robert; Allen, Colleen; Mooney, Larissa J; Haynes, Louise; Brigham, Gregory S; Sparenborg, Steve; Hasson, Albert L; Gray, Kevin M

    2014-11-01

    Despite recent advances in behavioral interventions for cannabis use disorders, effect sizes remain modest, and few individuals achieve long-term abstinence. One strategy to enhance outcomes is the addition of pharmacotherapy to complement behavioral treatment, but to date no efficacious medications targeting cannabis use disorders in adults through large, randomized controlled trials have been identified. The National Institute on Drug Abuse Clinical Trials Network (NIDA CTN) is currently conducting a study to test the efficacy of N-acetylcysteine (NAC) versus placebo (PBO), added to contingency management, for cannabis cessation in adults (ages 18-50). This study was designed to replicate positive findings from a study in cannabis-dependent adolescents that found greater odds of abstinence with NAC compared to PBO. This paper describes the design and implementation of an ongoing 12-week, intent-to-treat, double-blind, randomized, placebo-controlled study with one follow-up visit four weeks post-treatment. Approximately 300 treatment-seeking cannabis-dependent adults will be randomized to NAC or PBO across six study sites in the United States. The primary objective of this 12-week study is to evaluate the efficacy of twice-daily orally-administered NAC (1200 mg) versus matched PBO, added to contingency management, on cannabis abstinence. NAC is among the first medications to demonstrate increased odds of abstinence in a randomized controlled study among cannabis users in any age group. The current study will assess the cannabis cessation efficacy of NAC combined with a behavioral intervention in adults, providing a novel and timely contribution to the evidence base for the treatment of cannabis use disorders.

  4. A multicenter clinical study evaluating the confirmed complete molecular response rate in imatinib-treated patients with chronic phase chronic myeloid leukemia by using the international scale of real-time quantitative polymerase chain reaction

    PubMed Central

    Shinohara, Yoshinori; Takahashi, Naoto; Nishiwaki, Kaichi; Hino, Masayuki; Kashimura, Makoto; Wakita, Hisashi; Hatano, Yoshiaki; Hirasawa, Akira; Nakagawa, Yasuaki; Itoh, Kuniaki; Masuoka, Hidekazu; Aotsuka, Nobuyuki; Matsuura, Yasuhiro; Takahara, Sinobu; Sano, Koji; Kuroki, Jun; Hata, Tomoko; Nakamae, Hirohisa; Mugitani, Atsuko; Nakane, Takahiko; Miyazaki, Yasushi; Niioka, Takenori; Miura, Masatomo; Sawada, Kenichi

    2013-01-01

    Achievement of complete molecular response in patients with chronic phase chronic myeloid leukemia has been recognized as an important milestone in therapy cessation and treatment-free remission; the identification of predictors of complete molecular response in these patients is, therefore, important. This study evaluated complete molecular response rates in imatinib-treated chronic phase chronic myeloid leukemia patients with major molecular response by using the international standardization for quantitative polymerase chain reaction analysis of the breakpoint cluster region-Abelson1 gene. The correlation of complete molecular response with various clinical, pharmacokinetic, and immunological parameters was determined. Complete molecular response was observed in 75/152 patients (49.3%). In the univariate analysis, Sokal score, median time to major molecular response, ABCG2 421C>A, and regulatory T cells were significantly lower in chronic phase chronic myeloid leukemia patients with complete molecular response than in those without complete molecular response. In the multivariate analysis, duration of imatinib treatment (odds ratio: 1.0287, P=0.0003), time to major molecular response from imatinib therapy (odds ratio: 0.9652, P=0.0020), and ABCG2 421C/C genotype (odds ratio: 0.3953, P=0.0284) were independent predictors of complete molecular response. In contrast, number of natural killer cells, BIM deletion polymorphisms, and plasma trough imatinib concentration were not significantly associated with achieving a complete molecular response. Several predictive markers for achieving complete molecular response were identified in this study. According to our findings, some chronic myeloid leukemia patients treated with imatinib may benefit from a switch to second-generation tyrosine kinase inhibitors (ClinicalTrials.gov, UMIN000004935). PMID:23716542

  5. A comparative evaluation of freeze-dried bone allograft with and without bioabsorbable guided tissue regeneration membrane Healiguide® in the treatment of Grade II furcation defects: A clinical study

    PubMed Central

    Jain, Deept; Deepa, Dhruvakumar

    2015-01-01

    Background: Furcation defects represent one of the most demanding therapeutic challenges for periodontal therapy. Various treatment modalities have been tried with different success rates. The present study was undertaken to evaluate the efficacy of freeze-dried bone allograft (FDBA) with and without bioabsorbable guided tissue regeneration (GTR) membrane Healiguide® in the treatment of Grade II furcation defects. Materials and Methods: Ten patients with bilateral Grade II furcation defects were selected for the study. After phase I therapy, subjects were divided into two arms and treated in a split-mouth design. Ten defects were treated with FDBA alone in the control arm. Ten defects were treated with FDBA in conjunction with bioabsorbable GTR membrane Healiguide® in test arm. Clinical parameters like plaque index, gingival index, vertical probing depth, horizontal probing depth, and relative attachment level (RAL) were assessed at baseline, 3 months, and 6 months postoperatively. Results: At 6 months, clinical improvement was seen in both the arms with mean pocket depth reduction of 1.2 ± 1.032 mm and 1.7 ± 0.948 mm and mean horizontal probing depth reduction being 2.1 ± 1.969 mm and 1.6 ± 1.264 mm in control and test arm, respectively. Both surgical procedures resulted in a statistically significant reduction in vertical and horizontal probing depths. Conclusion: Both the arms demonstrated a significant improvement in the probing depth, horizontal furcation depth, and RAL at 6 months postsurgery in the treatment of Grade II furcation defects. However, on the intergroup comparison, there was no statistically significant difference in the results achieved between two arms. PMID:26941515

  6. A multicenter clinical study evaluating the confirmed complete molecular response rate in imatinib-treated patients with chronic phase chronic myeloid leukemia by using the international scale of real-time quantitative polymerase chain reaction.

    PubMed

    Shinohara, Yoshinori; Takahashi, Naoto; Nishiwaki, Kaichi; Hino, Masayuki; Kashimura, Makoto; Wakita, Hisashi; Hatano, Yoshiaki; Hirasawa, Akira; Nakagawa, Yasuaki; Itoh, Kuniaki; Masuoka, Hidekazu; Aotsuka, Nobuyuki; Matsuura, Yasuhiro; Takahara, Sinobu; Sano, Koji; Kuroki, Jun; Hata, Tomoko; Nakamae, Hirohisa; Mugitani, Atsuko; Nakane, Takahiko; Miyazaki, Yasushi; Niioka, Takenori; Miura, Masatomo; Sawada, Kenichi

    2013-09-01

    Achievement of complete molecular response in patients with chronic phase chronic myeloid leukemia has been recognized as an important milestone in therapy cessation and treatment-free remission; the identification of predictors of complete molecular response in these patients is, therefore, important. This study evaluated complete molecular response rates in imatinib-treated chronic phase chronic myeloid leukemia patients with major molecular response by using the international standardization for quantitative polymerase chain reaction analysis of the breakpoint cluster region-Abelson1 gene. The correlation of complete molecular response with various clinical, pharmacokinetic, and immunological parameters was determined. Complete molecular response was observed in 75/152 patients (49.3%). In the univariate analysis, Sokal score, median time to major molecular response, ABCG2 421C>A, and regulatory T cells were significantly lower in chronic phase chronic myeloid leukemia patients with complete molecular response than in those without complete molecular response. In the multivariate analysis, duration of imatinib treatment (odds ratio: 1.0287, P=0.0003), time to major molecular response from imatinib therapy (odds ratio: 0.9652, P=0.0020), and ABCG2 421C/C genotype (odds ratio: 0.3953, P=0.0284) were independent predictors of complete molecular response. In contrast, number of natural killer cells, BIM deletion polymorphisms, and plasma trough imatinib concentration were not significantly associated with achieving a complete molecular response. Several predictive markers for achieving complete molecular response were identified in this study. According to our findings, some chronic myeloid leukemia patients treated with imatinib may benefit from a switch to second-generation tyrosine kinase inhibitors (ClinicalTrials.gov, UMIN000004935).

  7. Performance evaluation and clinical applications of 3D plenoptic cameras

    NASA Astrophysics Data System (ADS)

    Decker, Ryan; Shademan, Azad; Opfermann, Justin; Leonard, Simon; Kim, Peter C. W.; Krieger, Axel

    2015-06-01

    The observation and 3D quantification of arbitrary scenes using optical imaging systems is challenging, but increasingly necessary in many fields. This paper provides a technical basis for the application of plenoptic cameras in medical and medical robotics applications, and rigorously evaluates camera integration and performance in the clinical setting. It discusses plenoptic camera calibration and setup, assesses plenoptic imaging in a clinically relevant context, and in the context of other quantitative imaging technologies. We report the methods used for camera calibration, precision and accuracy results in an ideal and simulated surgical setting. Afterwards, we report performance during a surgical task. Test results showed the average precision of the plenoptic camera to be 0.90mm, increasing to 1.37mm for tissue across the calibrated FOV. The ideal accuracy was 1.14mm. The camera showed submillimeter error during a simulated surgical task.

  8. Neural basis of nonanalytical reasoning expertise during clinical evaluation

    PubMed Central

    Durning, Steven J; Costanzo, Michelle E; Artino, Anthony R; Graner, John; van der Vleuten, Cees; Beckman, Thomas J; Wittich, Christopher M; Roy, Michael J; Holmboe, Eric S; Schuwirth, Lambert

    2015-01-01

    Introduction Understanding clinical reasoning is essential for patient care and medical education. Dual-processing theory suggests that nonanalytic reasoning is an essential aspect of expertise; however, assessing nonanalytic reasoning is challenging because it is believed to occur on the subconscious level. This assumption makes concurrent verbal protocols less reliable assessment tools. Methods Functional magnetic resonance imaging was used to explore the neural basis of nonanalytic reasoning in internal medicine interns (novices) and board-certified staff internists (experts) while completing United States Medical Licensing Examination and American Board of Internal Medicine multiple-choice questions. Results The results demonstrated that novices and experts share a common neural network in addition to nonoverlapping neural resources. However, experts manifested greater neural processing efficiency in regions such as the prefrontal cortex during nonanalytical reasoning. Conclusions These findings reveal a multinetwork system that supports the dual-process mode of expert clinical reasoning during medical evaluation. PMID:25798328

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

    PubMed

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

    1995-01-01

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

  10. Criteria for clinical translucency evaluation of direct esthetic restorative materials

    PubMed Central

    2016-01-01

    The purpose of this review was to suggest practical criteria for the clinical translucency evaluation of direct esthetic restorative materials, and to review the translucency with these criteria. For the evaluation of reported translucency values, measuring instrument and method, specimen thickness, background color, and illumination should be scrutinized. Translucency parameter (TP) of 15 to 19 could be regarded as the translucency of 1 mm thick human enamel. Visual perceptibility threshold for translucency difference in contrast ratio (ΔCR) of 0.07 could be transformed into ΔTP value of 2. Translucency differences between direct and indirect resin composites were perceivable (ΔTP > 2). Universal and corresponding flowable resin composites did not show perceivable translucency differences in most products. Translucency differed significantly by the product within each shade group, and by the shade group within each product. Translucency of human enamel and perceptibility threshold for translucency difference may be used as criteria for the clinical evaluation of translucency of esthetic restorative materials. PMID:27508156

  11. Criteria for clinical translucency evaluation of direct esthetic restorative materials.

    PubMed

    Lee, Yong-Keun

    2016-08-01

    The purpose of this review was to suggest practical criteria for the clinical translucency evaluation of direct esthetic restorative materials, and to review the translucency with these criteria. For the evaluation of reported translucency values, measuring instrument and method, specimen thickness, background color, and illumination should be scrutinized. Translucency parameter (TP) of 15 to 19 could be regarded as the translucency of 1 mm thick human enamel. Visual perceptibility threshold for translucency difference in contrast ratio (ΔCR) of 0.07 could be transformed into ΔTP value of 2. Translucency differences between direct and indirect resin composites were perceivable (ΔTP > 2). Universal and corresponding flowable resin composites did not show perceivable translucency differences in most products. Translucency differed significantly by the product within each shade group, and by the shade group within each product. Translucency of human enamel and perceptibility threshold for translucency difference may be used as criteria for the clinical evaluation of translucency of esthetic restorative materials. PMID:27508156

  12. Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

    PubMed Central

    Kobayashi, Naomi; Bonnard, Eric; Charbonnier, Colette; Yamamichi, Junta; Mizobe, Hideaki; Kimura, Shinya

    2015-01-01

    Background Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. Purpose To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Material and Methods Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. Results KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. Conclusion The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites. PMID:26668754

  13. Good clinical practices in phase I studies.

    PubMed

    Decousus, H; Perpoint, B; Mismetti, P; Ollagnier, M; Queneau, P

    1990-01-01

    In France, official guidelines for good clinical practices in clinical trials were issued in 1987. In December 1988, a law was passed that fixed the requirements for carrying out experiments in healthy subjects. It will be completed by official guidelines for the structures in which experiments on healthy subjects (and patients as well, when the investigation would not benefit the health of the patients) may be conducted. Hence a battery of recent legal instructions precisely state what good clinical practices are in the setting of phase I studies. Of particular importance are: subject recruitment and selection methods and procedures; specific competence of the investigator, in particular to interpret the pre-trial data; necessary and sufficient facilities to guarantee the subjects' safety; careful quality control to check all laboratory procedures; necessity of written standard operating procedures.

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

    PubMed

    Valtot, F

    2005-06-01

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

  15. Iranian Effective Clinical Nurse Instructor evaluation tool: Development and psychometric testing

    PubMed Central

    Shahsavari, Hooman; Yekta, Zohreh Parsa; Zare, Zahra; Sigaroodi, Abdolhossain Emami

    2014-01-01

    Background: Clinical education is the heart of the nursing education program. Effective nursing clinical instructors are needed for graduating the future qualified nurses. There is a well-developed body of knowledge about the effectiveness of clinical teaching and the instructors. However, translating this knowledge into a context-based evaluation tool for measuring the effectiveness of Iranian clinical nursing instructors remains a deficiency. The purpose of this study is to describe the development and psychometric testing process of an instrument to evaluate the characteristics of Iranian effective clinical nurse instructor. Materials and Methods: Following a precise review of Iranian literatures and expert consultation, 83 statements about the characteristics that make clinical nurse instructors effective were extracted. In the next phase, the psychometric properties of the instrument were established by looking at the content validity, face validity, and internal consistency. Content validity of the instrument was assessed based on the comments of an expert panel including 10 nursing faculty members. During this phase, 30 items of the instrument were omitted or merged. Face validity of the instrument was assured based on the advices of 10 nursing students and 10 nursing faculty members. Finally, in the pilot test, the data of 168 filled questionnaires were gathered and analyzed by an exploratory factor analysis to reduce the items and identify the factor structure of the instrument. Results: Through subsequent analyses, of the 83 items, 31 items were merged or omitted. At last, 52 retained items were divided into four subscales including student-centric behaviors, clinical performances, planning ability, and personality traits. The Cronbach's alpha level of the inventory was 0.96, with the value for each domain ranging from 0.87 to 0.94. Conclusions: Iranian Effective Clinical Nurse Instructor evaluation tool has acceptable psychometric properties and can be

  16. Industrial laser welding evaluation study

    NASA Technical Reports Server (NTRS)

    Hella, R.; Locke, E.; Ream, S.

    1974-01-01

    High power laser welding was evaluated for fabricating space vehicle boosters. This evaluation was made for 1/4 in. and 1/2 in. aluminum (2219) and 1/4 in. and 1/2 in. D6AC steel. The Avco HPL 10 kW industrial laser was used to perform the evaluation. The objective has been achieved through the completion of the following technical tasks: (1) parameter study to optimize welding and material parameters; (2) preparation of welded panels for MSFC evaluation; and (3) demonstration of the repeatability of laser welding equipment. In addition, the design concept for a laser welding system capable of welding large space vehicle boosters has been developed.

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

    PubMed Central

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

    2008-01-01

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

  18. Clinical evaluation of 860 anterior and posterior lithium disilicate restorations: retrospective study with a mean follow-up of 3 years and a maximum observational period of 6 years.

    PubMed

    Fabbri, Giacomo; Zarone, Fernando; Dellificorelli, Gianluca; Cannistraro, Giorgio; De Lorenzi, Marco; Mosca, Alberto; Sorrentino, Roberto

    2014-01-01

    This study aimed to assess the clinical performance of lithium disilicate restorations supported by natural teeth or implants. Eight hundred sixty lithium disilicate adhesive restorations, including crowns on natural teeth and implant abutments, veneers, and onlays, were made in 312 patients. Parafunctional patients were included, but subjects with uncontrolled periodontitis and gingival inflammation were excluded. Veneers up to 0.5 mm thick were luted with flowable composite resin or light curing cements, while dual-curing composite systems were used with veneers up to 0.8 mm thick. Onlays up to 2 mm in thickness were luted with flowable composite resins or dual-curing composite cements. Crowns up to 1 mm in thickness were cemented with self-adhesive or dual-curing resin cements. The observational period ranged from 12 to 72 months, with a mean follow-up of 3 years. The mechanical and esthetic outcomes of the restorations were evaluated according to the modified California Dental Association (CDA) criteria. Data were analyzed with descriptive statistics. Twenty-six mechanical complications were observed: 17 porcelain chippings, 5 fractures, and 4 losses of retention. Structural drawbacks occurred mainly in posterior segments, and monolithic restorations showed the lowest number of mechanical complications. The clinical ratings of the successful restorations, both monolithic and layered, were satisfactory according to the modified CDA criteria for color match, porcelain surface, and marginal integrity. The cumulative survival rates of lithium disilicate restorations ranged from 95.46% to 100%, while cumulative success rates ranged from 95.39% to 100%. All restorations recorded very high survival and success rates. The use of lithium disilicate restorations in fixed prosthodontics proved to be effective and reliable in the short- and medium-term.

  19. [Clinical studies of pediatric malabsorption syndromes].

    PubMed

    Hosoyamada, Takashi

    2006-11-01

    Multiple cases with various types of pediatric malabsorption syndromes were evaluated. The clinical manifestations, laboratory findings, pathophysiology, and histopathological descriptions of each patient were analyzed in an effort to clear the pathogenesis of the malabsorption syndromes and the treatments were undertaken. The cases studied, included one patient with cystic fibrosis, two with lactose intolerance with lactosuria (Durand type), one with primary intestinal lymphangiectasia, two with familial hypobetalipoproteinemia, one with Hartnup disease, one with congenital chroride diarrhea, one with acrodermatitis enteropathica, one with intestinal nodular lymphoid hyperplasia (NLH), five with intractable diarrhea of early infancy and four with glycogenosis type Ia. Each case description and outcome is described below: 1. A 15-year-old Japanese boy with cystic fibrosis presented with severe symptoms, including pancreatic insufficiency, bronchiectasis, pneumothorax and hemoptysis. His prognosis was poor. Analysis of the CFTR genes of this patient revealed a homozygous large deletion from intron 16 to 17b. 2. In the sibling case of Durand type lactose intolerance, the subjects'disaccaridase activity of the small bowel, including lactase, were within normal limits. The results of per oral and per intraduodenal lactose tolerance tests confirmed lactosuria in both. These observations suggested, not only an abnormal gastric condition, but also duodenal and intestinal mucosal abnormal permeability of lactose. 3. In the case of primary intestinal lymphangiectasia, the subject had a lymphedematous right arm and hand, a grossly coarsened mucosal pattern of the upper gastrointestinal tract (identified via radiologic examination) and the presence of lymphangiectasia (confirmed via duodenal mucosal biopsy). The major laboratory findings were hypoalbuminemia, decreased immunoglobulin levels and lymphopenia resulting from loss of lymph fluid and protein into the gastro

  20. Complications of acute pancreatitis: clinical and CT evaluation.

    PubMed

    Balthazar, Emil J

    2002-12-01

    Mortality of acute pancreatitis is dependent on the development of potentially lethal complications that can coexist and occur at any time following an acute attack. The nature and clinical relevance of these complications differ, contingent on the time of occurrence following a severe episode of pancreatitis. They can be divided into (1), early complications that manifest at the onset or within the first 2 to 3 days, (2) intermediate complications that occur predominantly during the second to fifth week, and (3) late complications that usually manifest months or years following the resolution of an acute attack. Early complications are systemic in nature with diverse clinical manifestations of the cardiovascular, pulmonary, renal, and/or metabolic systems. Intermediate complications are abdominal, pancreatic, and retroperitoneal, and are mostly septic in nature, associated with pancreatic or peripancreatic fat necrosis and pseudocysts. Late, life-threatening complications are mainly vascular or hemorrhagic in nature or involve the development of chronic pancreatic ascites. The early detection and objective evaluation of these complications by clinical and imaging methods leads to specific treatment options in the continuous attempt to decrease mortality rates in acute pancreatitis.

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

    PubMed

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

    2016-04-01

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

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

    PubMed Central

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

    2016-01-01

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

  3. Ongoing evaluation of PACS in a clinical setting

    NASA Astrophysics Data System (ADS)

    Trefler, Martin; Russell, Edward

    1992-05-01

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

  4. Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine.

    PubMed

    Precioso, Alexander Roberto; Palacios, Ricardo; Thomé, Beatriz; Mondini, Gabriella; Braga, Patrícia; Kalil, Jorge

    2015-12-10

    Butantan Institute is a public Brazilian biomedical research-manufacturer center affiliated to the São Paulo State Secretary of Health. Currently, Butantan is one of the main public producers of vaccines, antivenoms, and antitoxins in Latin America. The partnership between Butantan and the National Institutes of Health (NIH) of the United Sates has been one of the longest and most successful partnerships in the development and manufacturing of new vaccines. Recently, Butantan Institute has developed and manufactured a lyophilized tetravalent live attenuated dengue vaccine with the four dengue viruses attenuated and licensed from the Laboratory of Infectious Diseases at The National Institutes of Allergy and Infectious Diseases (LID/NIAID/NIH). The objective of this paper is to describe the clinical evaluation strategies of a live attenuated tetravalent dengue vaccine (Butantan-DV) developed and manufactured by Butantan Institute. These clinical strategies will be used to evaluate the Butantan-DV Phase III trial to support the Butantan-DV licensure for protection against any symptomatic dengue caused by any serotype in people aged 2 to 59 years.

  5. Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism in healthy individuals without symptoms of arthritis: A randomized double-blind placebo-controlled clinical study

    PubMed Central

    Tomonaga, Akihito; Watanabe, Keita; Fukagawa, Mitsuhiko; Suzuki, Asahi; Kurokawa, Mihoko; Nagaoka, Isao

    2016-01-01

    The present study aimed to evaluate the effect of N-acetyl-glucosamine (GlcNAc) on the joint health of healthy individuals without arthritic symptoms. A randomized double-blind placebo-controlled clinical trial was performed to investigate the effect of oral administration of a GlcNAc-containing test supplement (low dose, 500 mg/day and high dose, 1,000 mg/day) on cartilage metabolism in healthy individuals with a mean age of 48.6±1.3 years (range, 23–64 years) by analyzing the ratio of type II collagen degradation to type II collagen synthesis using type II collagen degradation (C2C) and synthesis (PIICP) markers. The results indicated that the changes in C2C/PIICP ratios from the baseline were suppressed in the treated with low and high doses of GlcNAc, compared with the placebo group at week 16 during intervention. To further elucidate the effect of GlcNAc, subjects with impaired cartilage metabolism were evaluated. Notably, the changes in the C2C/PIICP ratios were markedly suppressed in the groups treated with low and high doses of GlcNAc at week 16. Finally, to exclude the effect of heavy body weight on joint loading, subjects weighing <70 kg with impaired cartilage metabolism were analyzed. Notably, the changes in the C2C/PIICP ratios were suppressed in the groups treated with low and high doses of GlcNAc at weeks 12 and 16. No test supplement-related adverse events were observed during or following the intervention. Together, these observations suggest that oral administration of GlcNAc at doses of 500 mg and 1,000 mg/day exhibits a chondroprotective effect on healthy individuals by reducing the C2C/PIICP ratio (relatively decreasing type II collagen degradation and increasing type II collagen synthesis) without any apparent adverse effects. PMID:27588069

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

    PubMed

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

    2015-10-01

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

  7. Clinical characteristics and therapeutic evaluation of childhood myasthenia gravis

    PubMed Central

    YANG, ZHI-XIAO; XU, KAI-LI; XIONG, HUI

    2015-01-01

    This study aimed to analyze the clinical characteristics, classification and treatment of childhood myasthenia gravis (MG) and address the prognosis through follow-up. The clinical data of 135 children with MG were grouped according to clinical type and therapeutic drugs, retrospectively analyzed and prospectively monitored. Of the 135 MG patients, 85.2% had type I (ocular type), with only 4.2% progressing to systemic MG; 13.4% had type II (general type); and 1.5% had type III (fulminating type). Relapse occurred in 46.1% of the 102 patients that were followed up. The positive rate for the primary acetylcholine receptor antibody was 40.19%, without significant differences among clinical subtypes. The positive rate of the repetitive nerve stimulation frequency test by electromyography was 37.97%. Decreased expression of CD4+, CD8+, or CD3+ was present in 71% of the patients. Thymic hyperplasia was present in 5.93% of the patients, while 1.48% had thymoma. Steroid treatment was effective in the majority of the patients. Ocular type MG was common in this cohort of patients. The incidence and mortality of myasthenia crisis were low, the presence of concurrent thymoma was rare and only a limited number of children developed neurological sequelae. PMID:25780436

  8. The reliability of British Sign Language and English versions of the Clinical Outcomes in Routine Evaluation--Outcome Measure with d/Deaf populations in the UK: an initial study.

    PubMed

    Rogers, Katherine; Evans, Chris; Campbell, Malcolm; Young, Alys; Lovell, Karina

    2014-05-01

    Previous research has argued that the mental well-being of d/Deaf people is poorer than that of hearing populations. However, there is a paucity of valid and reliable mental health instruments in sign language that have been normalised with d/Deaf populations. The aim of this study was to determine the reliability of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) with d/Deaf populations. A British Sign Language (BSL) version was produced using a team approach to forward translation, and a back-translation check. The CORE-OM was incorporated into an online survey, to be completed in either BSL or English, as preferred by the participant. From December 2010 to March 2011, data were collected from 136 d/Deaf people. Cronbach's α was used to measure the internal consistency of items in the CORE-OM. Comparisons were made between versions, including comparisons with the non-clinical hearing population (not in receipt of mental health services) in a previous study. The reliability of the overall score, as well as the non-risk items in both the BSL and English versions, was satisfactory. The internal reliability of each domain in the BSL version was good (Cronbach's α > 0.70) and comparable to the English version in the hearing population. This was true for most domains of the CORE-OM in the English version completed by d/Deaf people, although the Functioning domain had a relatively low α of 0.79 and the Risk domain had an α of only 0.66 This raised the question whether it is advisable to use a mental health assessment with d/Deaf populations that has been standardised with hearing populations. Nevertheless, this study has shown that it is possible to collect data from d/Deaf populations in the UK via the web (both in BSL and English), and an online BSL version of the CORE-OM is recommended for use with Deaf populations in the community.

  9. Interim Outcomes Assessment of the Comprehensive Clinical Performance Grid for Student Evaluation.

    ERIC Educational Resources Information Center

    Tolls, Dorothy Bazzinotti; Carlson, Nancy; Wilson, Roger; Richman, Jack

    2001-01-01

    Assessed the viability of the Comprehensive Clinical Performance Grid for Student Evaluation, introduced at The New England College of Optometry in 1996 in clinical student assessment. Analyzed faculty and student feedback and consistency with previous evaluations, between evaluators, and between clinical sites and tracts. Found satisfaction with…

  10. Evaluation of Chemotherapy-Induced Peripheral Neuropathy using Current Perception Threshold and Clinical Evaluations

    PubMed Central

    Griffith, Kathleen A.; Couture, Darren J.; Zhu, Shijun; Pandya, Naimish; Johantgen, Mary E.; Cavaletti, Guido; Davenport, Joan M.; Tanguay, Lori J.; Choflet, Amanda; Milliron, Todd; Glass, Erica; Gambill, Nancy; Renn, Cynthia L.; Dorsey, Susan G.

    2014-01-01

    Purpose Chemotherapy-induced peripheral neuropathy (CIPN) is increasing with introduction of new and combination cancer pharmacotherapies. This study evaluated associations between clinical and self-report measurements and current perception threshold (CPT), a neuroselective measure of sensory nerve function that may detect asymptomatic CIPN damage. Methods Data for this secondary analysis were from a prospective, observational study using CPT to evaluate CIPN. Bivariate mixed models, accounting for the intra-class correlation between repeated patient assessments, were used to assess the relationship between CPT at each frequency (5Hz, 250Hz and 2000 Hz) and each subjective measure (Neuropathic Pain Scale, FACT-GOGntx) and objective measurement (quantitative sensory testing, deep tendon reflexes, grip strength). Results A total of 29 chemotherapy-naïve subjects with various cancer types had a mean age of 56.7 (SD 10.4); 9 subjects developed CIPN grade > 1 using NCI CTC-AE criteria. Cold detection thresholds were inversely associated with CPT 5 [b(95% CI) =−2.5(−4.5, −0.5)] and CPT 2000 [−7.5(−11.8, −3.3)] frequencies. FACT GOG-ntx quality of life (QoL) scale and neurotoxicity and function subscales were inversely associated with CPT 2000 [−1.8 (−3.5, −0.05), −2.2 (−4.2, −0.2), and −5.4(−9.8, −0.9), respectively], indicating worsening QoL, impairment, and function as hypoesthesia increases. Conclusions CPT 2000 may identify impending worsening of patient-reported outcomes, such as QoL. PMID:24362842

  11. Assessing students' English language proficiency during clinical placement: A qualitative evaluation of a language framework.

    PubMed

    San Miguel, Caroline; Rogan, Fran

    2015-06-01

    The increase in nursing students for whom English is an additional language requires clinical facilitators to assess students' performance regarding clinical skills, nursing communication and English language. However, assessing language proficiency is a complex process that is often conflated with cultural norms and clinical skills, and facilitators may lack confidence in assessing English language. This paper discusses an evaluation of a set of guidelines developed in a large metropolitan Australian university to help clinical facilitators make decisions about students' English language proficiency. The study found that the guidelines were useful in helping facilitators assess English language. However, strategies to address identified language problems needed to be incorporated to enable the guidelines to also be used as a teaching tool. The study concludes that to be effective, such guidelines need embedding within a systematic approach that identifies and responds to students who may be underperforming due to a low level of English language proficiency.

  12. Assessing students' English language proficiency during clinical placement: A qualitative evaluation of a language framework.

    PubMed

    San Miguel, Caroline; Rogan, Fran

    2015-06-01

    The increase in nursing students for whom English is an additional language requires clinical facilitators to assess students' performance regarding clinical skills, nursing communication and English language. However, assessing language proficiency is a complex process that is often conflated with cultural norms and clinical skills, and facilitators may lack confidence in assessing English language. This paper discusses an evaluation of a set of guidelines developed in a large metropolitan Australian university to help clinical facilitators make decisions about students' English language proficiency. The study found that the guidelines were useful in helping facilitators assess English language. However, strategies to address identified language problems needed to be incorporated to enable the guidelines to also be used as a teaching tool. The study concludes that to be effective, such guidelines need embedding within a systematic approach that identifies and responds to students who may be underperforming due to a low level of English language proficiency. PMID:25784501

  13. Use of anecdotal notes by clinical nursing faculty: a descriptive study.

    PubMed

    Hall, Mellisa A; Daly, Barbara J; Madigan, Elizabeth A

    2010-03-01

    Although the use of anecdotal notes by faculty to document clinical performance is thought to be a common practice, no empirical study of this evaluation tool has been conducted. To investigate the frequency and pattern of use, a faculty questionnaire was developed using the Context, Input, Process, Product (CIPP) evaluation model as a framework. The model was adapted to focus on clinical nursing education. Sixty-four nursing faculty from six schools participated in the regional study. A descriptive design was used to collect quantitative data from clinical faculty. Findings indicated that 97% of clinical faculty use anecdotal notes during the student evaluation process, and the majority of faculty do so on a weekly basis. Based on faculty feedback and the CIPP evaluation model, a clinical nursing faculty tool was developed after study completion to support clinical faculty in note use.

  14. [Evaluation of clinical competence in the nursing profession].

    PubMed

    Solà Pola, Montserrat; Molins Mesalles, Ainhoa; Martínez Carretero, Josep Maria

    2005-01-01

    The quality of health services depends on the competence of the health service professionals. It is essential to define and evaluate professional competences in order to improve professional development, ensure the quality of, and manage, professionals in terms of their competences. To do so, it is necessary to utilize a combination of different methods. The evaluation of the diverse stages related to nursing--at the end of undergraduate studies, postgraduate studies or specialization, and during independent work--has different proposals, content and methods; and the institutions implicated in these stages should make themselves responsible to acquire the professional which society needs. Since 1994, more than 150 projects have been carried out in Catalonia which confirm the validity, trustworthiness, acceptability and utility of these evaluative methods in undergraduate and postgraduate studies and in the selection and accreditation of professionals.

  15. Integrating economic evaluation methods into clinical and translational science award consortium comparative effectiveness educational goals.

    PubMed

    Iribarne, Alexander; Easterwood, Rachel; Russo, Mark J; Wang, Y Claire

    2011-06-01

    With the ongoing debate over health care reform in the United States, public health and policy makers have paid growing attention to the need for comparative effectiveness research (CER). Recent allocation of federal funds for CER represents a significant move toward increased evidence-based practice and better-informed allocation of constrained health care resources; however, there is also heated debate on how, or whether, CER may contribute to controlling national health care expenditures. Economic evaluation, in the form of cost-effectiveness or cost-benefit analysis, is often an aspect of CER studies, yet there are no recommendations or guidelines for providing clinical investigators with the necessary skills to collect, analyze, and interpret economic data from clinical trials or observational studies. With an emphasis on multidisciplinary research, the Clinical and Translational Science Award (CTSA) consortium and institutional CTSA sites serve as an important resource for training researchers to engage in CER. In this article, the authors discuss the potential role of CTSA sites in integrating economic evaluation methods into their comparative effectiveness education goals, using the Columbia University Medical Center CTSA as an example. By allowing current and future generations of clinical investigators to become fully engaged not only in CER but also in the economic evaluations that result from such analyses, CTSA sites can help develop the necessary foundation for advancing research to guide clinical decision making and efficient use of limited resources.

  16. Development of quality indicators to evaluate the monitoring of SLE patients in routine clinical practice

    PubMed Central

    Mosca, M.; Tani, C.; Aringer, M.; Bombardieri, S.; Boumpas, D.; Cervera, R.; Doria, A.; Jayne, D.; Khamashta, M. A.; Kuhn, A.; Gordon, C.; Petri, M.; Schneider, M.; Shoenfeld, Y.; Smolen, J. S.; Talarico, R.; Tincani, A.; Ward, M. M.; Werth, V. P.; Carmona, L.

    2014-01-01

    The assessment of systemic lupus erythematosus (SLE) patients in routine clinical practice is mainly based on the experience of the treating physician. This carries the risk of unwanted variability. Variability may have an impact on the quality of care offered to SLE patients, thereby affecting outcomes. Recommendations represent systematically developed statements to help practitioners in reducing variability. However, major difficulties arise in the application of recommendations into clinical practice. In this respect, the use of quality indicators may raise the awareness among rheumatologists regarding potential deficiencies in services and improve the quality of health care. The aim of this study was to develop a set of quality indicators (QI) for SLE by translating into QIs the recently developed EULAR Recommendations for monitoring SLE patients in routine clinical practice and observational studies. Eleven QIs have been developed referring to the use of validated activity and damage indices in routine clinical practice, general evaluation of drug toxicity, evaluation of comorbidities, eye evaluation, laboratory assessment, evaluation of the presence of chronic viral infections, documentation of vaccination and of antibody testing at baseline. A disease specific set of quality assessment tools should help physicians deliver high quality of care across populations. Routine updates will be needed. PMID:21224016

  17. DNA Damage in Chronic Kidney Disease: Evaluation of Clinical Biomarkers

    PubMed Central

    Schupp, Nicole; Stopper, Helga; Heidland, August

    2016-01-01

    Patients with chronic kidney disease (CKD) exhibit an increased cancer risk compared to a healthy control population. To be able to estimate the cancer risk of the patients and to assess the impact of interventional therapies thereon, it is of particular interest to measure the patients' burden of genomic damage. Chromosomal abnormalities, reduced DNA repair, and DNA lesions were found indeed in cells of patients with CKD. Biomarkers for DNA damage measurable in easily accessible cells like peripheral blood lymphocytes are chromosomal aberrations, structural DNA lesions, and oxidatively modified DNA bases. In this review the most common methods quantifying the three parameters mentioned above, the cytokinesis-block micronucleus assay, the comet assay, and the quantification of 8-oxo-7,8-dihydro-2′-deoxyguanosine, are evaluated concerning the feasibility of the analysis and regarding the marker's potential to predict clinical outcomes. PMID:27313827

  18. Clinical evaluation of Er:YAG laser caries treatment

    NASA Astrophysics Data System (ADS)

    Dostalova, Tatjana; Jelinkova, Helena; Kucerova, Hana; Krejsa, Otakar; Hamal, Karel; Kubelka, Jiri; Prochazka, Stanislav

    1997-05-01

    To prepare the enamel, the energy used was mainly 345 mJ and repetition rate 2 Hz, for dentine the optimal energy of Er:YAG drilling machine was 200 mJ and repetition rate from 1 to 2 Hz, depending on cavity depth. Subject of treatment were caries of enamel and dentine and it was possible to remove the old insufficient fillings. The average number of pulses was 111.22, ranging from 16 to 489. During preparation, vibrations of microexplosions were felt by 8 patients, however, neither pain or unpleasant sensations were experienced. The filling materials used were composite resins and glassionomer cements. Their clinical evaluation 6 months post insertion was similar to that of the classical drilling system.

  19. Food allergy in infants and children: clinical evaluation and management.

    PubMed

    Levy, Y; Kornbroth, B; Ofer, I; Garty, B Z; Danon, Y L

    1994-12-01

    A total of 122 infants and children up to age 17 (69 males and 53 females) who were referred for food allergy to the Pediatric Allergy and Clinical Immunology Unit were evaluated by complete history, emphasizing the implicated foods, clinical presentation and involvement of various organ systems, physical examination, and prick skin tests to food allergens. Fourteen infants with a history of egg white allergy and positive skin tests to egg white also underwent skin tests (prick and intradermal in 1:100 dilution) to measles-mumps-rubella (MMR) vaccine; 35 children under 3 years old had 41 oral challenges with the suspected foods; and 9 children over 3 years old had 12 oral challenges with the suspected foods. We found that cow milk/humanized milk formula, egg white, soybean, and peanut are the main allergenic foods in the pediatric population. Thirteen children had 13 positive oral challenges: 12 to cow milk/humanized milk formula and one to egg white. Symptoms reproduced by oral challenges included urticarial and erythematous rash, conjunctival itching, angioedema, abdominal pain, vomiting, diarrhea, and rhinorrhea. No anaphylactic shock was reported. Negative skin test has an excellent predictive accuracy for negative oral challenge with the suspected food in children > 3 years old. The negative predictive accuracy of cow milk skin test in children < 3 years was 73%. Positive skin test is not a good predictor of a clinical reaction to food. Oral food challenge performed cautiously in a medical setting is the "gold standard" for diagnosis. MMR vaccine can be safely administered to infants with egg white allergy after skin tests with the vaccine are performed.

  20. Clinical evaluation of the Vitek Neisseria-Haemophilus Identification card.

    PubMed

    Janda, W M; Malloy, P J; Schreckenberger, P C

    1987-01-01

    A clinical evaluation of the Vitek Neisseria-Haemophilus Identification (NHI) card (Vitek Systems, Inc., Hazelwood, Mo.) was performed with 480 clinical isolates and stock strains of Neisseria spp., Haemophilus spp., and other fastidious microorganisms included in the data base of the system. Identifications obtained with the NHI card were compared with those determined by conventional methods. The card identified 83.2% of 244 Neisseria spp. and Branhamella catarrhalis, 54.9% of 164 Haemophilus spp., and 84.7% of 72 fastidious gram-negative species with no further testing required. Some isolates produced good confidence-marginal separation identifications, in which the correct identification was listed with one or two other possible identifications and extra tests were required and suggested. When isolates producing good confidence-marginal separation identifications were included, correct identifications of these organism groups increased to 97.1, 92.7, and 94.4%, respectively. Among the commonly isolated microorganisms, the NHI card identified 99.1% of 110 N. gonorrhoeae, 98.5% of 68 N. meningitidis, 93.9% of 98 H. influenzae, and 95.6% of 46 H. parainfluenzae strains. All of these organisms produced excellent to very good confidence level identifications except for H. influenzae biotypes II, III, and VII, for which hemolytic reactions were required for differentiation from H. haemolyticus. The NHI card reliably identified other fastidious gram-negative species, including H. aphrophilus, Eikenella corrodens, Gardnerella vaginalis, and Kingella denitrificans.

  1. Clinical evaluation of the Vitek Neisseria-Haemophilus Identification card.

    PubMed Central

    Janda, W M; Malloy, P J; Schreckenberger, P C

    1987-01-01

    A clinical evaluation of the Vitek Neisseria-Haemophilus Identification (NHI) card (Vitek Systems, Inc., Hazelwood, Mo.) was performed with 480 clinical isolates and stock strains of Neisseria spp., Haemophilus spp., and other fastidious microorganisms included in the data base of the system. Identifications obtained with the NHI card were compared with those determined by conventional methods. The card identified 83.2% of 244 Neisseria spp. and Branhamella catarrhalis, 54.9% of 164 Haemophilus spp., and 84.7% of 72 fastidious gram-negative species with no further testing required. Some isolates produced good confidence-marginal separation identifications, in which the correct identification was listed with one or two other possible identifications and extra tests were required and suggested. When isolates producing good confidence-marginal separation identifications were included, correct identifications of these organism groups increased to 97.1, 92.7, and 94.4%, respectively. Among the commonly isolated microorganisms, the NHI card identified 99.1% of 110 N. gonorrhoeae, 98.5% of 68 N. meningitidis, 93.9% of 98 H. influenzae, and 95.6% of 46 H. parainfluenzae strains. All of these organisms produced excellent to very good confidence level identifications except for H. influenzae biotypes II, III, and VII, for which hemolytic reactions were required for differentiation from H. haemolyticus. The NHI card reliably identified other fastidious gram-negative species, including H. aphrophilus, Eikenella corrodens, Gardnerella vaginalis, and Kingella denitrificans. PMID:3539996

  2. Evaluating the efficacy of memantine on improving cognitive functions in epileptic patients receiving anti-epileptic drugs: A double-blind placebo-controlled clinical trial (Phase IIIb pilot study)

    PubMed Central

    Marimuthu, Priya; Varadarajan, Sathyanarayanan; Krishnan, Muthuraj; Shanmugam, Sundar; Kunjuraman, Gireesh; Ravinder, Jamuna Rani; Arumugam, Balasubramanian; Alex, Divya; Swaminathan, Porchelvan

    2016-01-01

    Objectives: People with epilepsy have greater cognitive and behavioral dysfunction than the general population. There is no specific treatment available for cognitive impairment of these patients. We aimed to evaluate the effects of memantine, an N-methyl-D-aspartate-type glutamate receptor noncompetitive antagonist, on improving cognition and memory functions in epileptic patients with cognitive and memory impairment, who received anti-epileptic drugs (AEDs). Methods: We did a randomized, double-blind, placebo-controlled parallel group trial, in SRM Medical College Hospital and Research Centre, Kattankulathur, Kancheepuram, Tamil Nadu, India between April 2013 and September 2013. Fifty-nine epileptic patients taking AEDs with subjective memory complaints were recruited and randomized to either Group 1 to receive 16 weeks of once-daily memantine, (5 mg for first 8 weeks, followed by memantine 10 mg for next 8 weeks) or Group 2 to receive once daily placebo. This trial is registered with Clinical Trial Registry of India CTRI/2013/04/003573. Results: Of 59 randomized patients, 55 patients completed the study (26 memantine and 29 placebo). Memantine group showed statistically significant improvement in total mini mental state examination score from baseline (P = 0.765) to 16th week (P < 0.001) in comparison with the placebo. The Weshler's Memory Scale total score in memantine group improved significantly after 8 weeks (P = 0.002) compared with baseline (P = 0.873) and highly significant at the end of 16th week (P < 0.001). The self-rated quality of life and memory in memantine group also significantly improved at the study end. Conclusion: We conclude that once-daily memantine (10 mg) treatment significantly improved cognition, memory and quality of life in epileptic patients with mild to moderate cognitive impairment and was found to have a favorable safety profile. PMID:27570386

  3. [Depression and dementia: perspectives from clinical studies].

    PubMed

    Nozaki, Shoko; Yoshimura, Kimio; Mimura, Masaru

    2012-12-01

    In this review, we present an overview of clinical studies that addressed the relationship between depression and dementia or cognitive decline. Cross-sectional studies and meta-analyses have repeatedly shown an association between late-life depression (LLD) and dementia, particularly Alzheimer's disease (AD) and vascular dementia; however, the findings of cohort studies have been inconsistent. Furthermore, studies on the association between depression with a younger age of onset and dementia have yielded inconsistent results. Regarding cognitive decline associated with LLD, several studies have reported an association between LLD and mild cognitive impairment, suggesting that depression itself can cause persistent cognitive impairment. Other studies have compared the cognitive profile between LLD and depression with a younger age of onset, but their results have been inconclusive, especially regarding the association between memory impairment and the age of onset of depression. LLD is associated with vascular change and white matter degeneration of the brain, as shown by magnetic resonance imaging (MRI). Recently, several studies reported an association between gray matter change and LLD. Studies currently in progress employ functional brain imaging methods such as single-photon emission computed tomography, functional MRI, and positron emission tomography. Clinically, it is important to understand how subtypes of depression can be defined in terms of risk of developing dementia, and to devise effective treatments. One paper explored the possibility of detecting depression associated with AD by measuring the blood Aβ40/Aβ42 levels, and other studies have suggested that symptoms of apathy and loss of interest are associated with conversion of depression to AD. Unfortunately, current antidepressants may have limited efficacy on depression with dementia; therefore, further investigation for devising methods of predicting conversion of depression to dementia and

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

    PubMed

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

    2015-01-01

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

  5. Technology-Assisted Patient Access to Clinical Information: An Evaluation Framework for Blue Button

    PubMed Central

    Nazi, Kim M; Luger, Tana M; Amante, Daniel J; Smith, Bridget M; Barker, Anna; Shimada, Stephanie L; Volkman, Julie E; Garvin, Lynn; Simon, Steven R; Houston, Thomas K

    2014-01-01

    Background Patient access to clinical information represents a means to improve the transparency and delivery of health care as well as interactions between patients and health care providers. We examine the movement toward augmenting patient access to clinical information using technology. Our analysis focuses on “Blue Button,” a tool that many health care organizations are implementing as part of their Web-based patient portals. Objective We present a framework for evaluating the effects that technology-assisted access to clinical information may have on stakeholder experiences, processes of care, and health outcomes. Methods A case study of the United States Department of Veterans Affairs' (VA) efforts to make increasing amounts of clinical information available to patients through Blue Button. Drawing on established collaborative relationships with researchers, clinicians, and operational partners who are engaged in the VA’s ongoing implementation and evaluation efforts related to Blue Button, we assessed existing evidence and organizational practices through key informant interviews, review of documents and other available materials, and an environmental scan of published literature and the websites of other health care organizations. Results Technology-assisted access to clinical information represents a significant advance for VA patients and marks a significant change for the VA as an organization. Evaluations of Blue Button should (1) consider both processes of care and outcomes, (2) clearly define constructs of focus, (3) examine influencing factors related to the patient population and clinical context, and (4) identify potential unintended consequences. Conclusions The proposed framework can serve as a roadmap to guide subsequent research and evaluation of technology-assisted patient access to clinical information. To that end, we offer a series of related recommendations. PMID:24675395

  6. Planning a study abroad clinical experience.

    PubMed

    Wright, Dolores J

    2010-05-01

    Not only is globalization expanding areas of human activity, it is also influencing the variety of educational offerings in universities. Therefore, globalization must be considered by nurse educators as they reevaluate ways of preparing nursing students to meet the health care needs of populations they currently serve and will care for in the future. Study abroad programs have been encouraged to be part of the college experience in the United States for more than 30 years; however, these programs have been relatively lacking in nursing education. Most of the study abroad programs described in the nursing literature are research-based or first-person accounts of an experience and provide little information about planning a study abroad program. This article describes a study abroad learning experience for senior nursing students and discusses the issues such as student selection, student safety, and available clinical experiences that need to be considered before undertaking such an endeavor. PMID:20143756

  7. Evaluation of the William S. Hall Psychiatric Institute Clinical Psychology Internship: a replication and extension.

    PubMed

    Stader, Sandra R; Myers, DeRosset; Forand, Angela Q; Holmes, George R; McNulty, George F; Frey, Linda; Bolton, Staci S

    2010-12-01

    This study extends three earlier investigations involving participants who completed their predoctoral clinical psychology internship at the William S. Hall Psychiatric Institute. Intern graduates (N = 37) evaluated how effectively their internship training prepared them for seven aspects of their current work as practicing psychologists. Participants also rated the relevancy of 24 different internship training experiences to their current work and how much these experiences contributed to their development as clinical psychologists. The present study, in conjunction with the three previous studies, covers most of the 40-year period since the inception of the internship program. Analysis of the current data indicates the internship has improved over time and was deemed an exceptional training experience by its graduates. Findings may be of particular interest to internship directors and faculty interested in improving their training program and those who plan to conduct a self-study to maintain their accreditation for clinical psychology internship.

  8. [A clinical study of generalized amnesia].

    PubMed

    Takahashi, Y

    1989-01-01

    Six cases of generalized amnesia were reported. Generalized amnesia caused by phenomena of genuinely psychogenic origin is a rare psychological disorder and spontaneous recovery from amnesia in a comparatively short period of time is one of the characteristics of this disorder. Three of the cases in this report developed amnesia which was prolonged in comparison with previously reported cases. A comparison between these six cases and previously reported cases of amnesia elucidated the general characteristics of this disorder, differential diagnosis from other disorders, the development of a new identity during the amnestic period, amnesia as an alternative to suicide, factors related to prolonged amnesia, and its treatment. Although differential diagnosis from other disorders, especially from malingering, is sometimes difficult, the patient's attitude toward amnesia, the development of the clinical course of amnesia, the premorbid personal history, and interpersonal relationships should be carefully observed and evaluated in order to differentiate generalized amnesia from malingering. During the amnestic period it was observed that three of the cases believed that they had names of other persons, and two of them recalled personal histories completely different from their own. Previously, such phenomena have been mainly discussed from the view-point of pseudologia fantastica or malingering in Japan. The author discusses how a new identity could be developed in cases of generalized amnesia. According to Abeles, et al., generalized amnesia can sometimes serve as psychological suicide. The author emphasizes that the patient's suicidal risk should be evaluated carefully, even if he or she does not seem highly suicidal superficially. Excessive haste to recover from amnesia may heighten the suicidal risk or help develop a distorted personal identity. The principle for the treatment is to exclude an unnecessary therapeutic manipulation and maintain a consistent and

  9. Clinical and genomic analysis of a randomised phase II study evaluating anastrozole and fulvestrant in postmenopausal patients treated for large operable or locally advanced hormone-receptor-positive breast cancer

    PubMed Central

    Quenel-Tueux, Nathalie; Debled, Marc; Rudewicz, Justine; MacGrogan, Gaetan; Pulido, Marina; Mauriac, Louis; Dalenc, Florence; Bachelot, Thomas; Lortal, Barbara; Breton-Callu, Christelle; Madranges, Nicolas; de Lara, Christine Tunon; Fournier, Marion; Bonnefoi, Hervé; Soueidan, Hayssam; Nikolski, Macha; Gros, Audrey; Daly, Catherine; Wood, Henry; Rabbitts, Pamela; Iggo, Richard

    2015-01-01

    Background: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast cancer not eligible for initial breast-conserving surgery, and to identify genomic changes occurring after treatment. Methods: One hundred and twenty post-menopausal patients were randomised to receive 1 mg anastrozole (61 patients) or 500 mg fulvestrant (59 patients) for 6 months. Genomic DNA copy number profiles were generated for a subgroup of 20 patients before and after treatment. Results: A total of 108 patients were evaluable for efficacy and 118 for toxicity. The objective response rate determined by clinical palpation was 58.9% (95% CI=45.0–71.9) in the anastrozole arm and 53.8% (95% CI=39.5–67.8) in the fulvestrant arm. The breast-conserving surgery rate was 58.9% (95% CI=45.0–71.9) in the anastrozole arm and 50.0% (95% CI=35.8–64.2) in the fulvestrant arm. Pathological responses >50% occurred in 24 patients (42.9%) in the anastrozole arm and 13 (25.0%) in the fulvestrant arm. The Ki-67 score fell after treatment but there was no significant difference between the reduction in the two arms (anastrozole 16.7% (95% CI=13.3–21.0) before, 3.2% (95% CI=1.9–5.5) after, n=43; fulvestrant 17.1% (95%CI=13.1–22.5) before, 3.2% (95% CI=1.8–5.7) after, n=38) or between the reduction in Ki-67 in clinical responders and non-responders. Genomic analysis appeared to show a reduction of clonal diversity following treatment with selection of some clones with simpler copy number profiles. Conclusions: Both anastrozole and fulvestrant were effective and well-tolerated, enabling breast-conserving surgery in over 50% of patients. Clonal changes consistent with clonal selection by the treatment were seen in a subgroup of patients. PMID:26171933

  10. Non-Clinical Safety Evaluation of Intranasal Iota-Carrageenan

    PubMed Central

    Hebar, Alexandra; Koller, Christiane; Seifert, Jan-Marcus; Chabicovsky, Monika; Bodenteich, Angelika; Bernkop-Schnürch, Andreas; Grassauer, Andreas; Prieschl-Grassauer, Eva

    2015-01-01

    Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded) iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug’s action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application. PMID:25875737

  11. Evaluation of the clinical chemistry analyser Olympus AU400.

    PubMed

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

    2000-10-01

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

  12. Ligand-targeted particulate nanomedicines undergoing clinical evaluation: current status.

    PubMed

    van der Meel, Roy; Vehmeijer, Laurens J C; Kok, Robbert J; Storm, Gert; van Gaal, Ethlinn V B

    2013-10-01

    Since the introduction of Doxil® on the market nearly 20years ago, a number of nanomedicines have become part of treatment regimens in the clinic. With the exception of antibody-drug conjugates, these nanomedicines are all devoid of targeting ligands and rely solely on their physicochemical properties and the (patho)physiological processes in the body for their biodistribution and targeting capability. At the same time, many preclinical studies have reported on nanomedicines exposing targeting ligands, or ligand-targeted nanomedicines, yet none of these have been approved at this moment. In the present review, we provide a concise overview of 13 ligand-targeted particulate nanomedicines (ligand-targeted PNMs) that have progressed into clinical trials. The progress of each ligand-targeted PNM is discussed based on available (pre)clinical data. Main conclusions of these analyses are that (a) ligand-targeted PNMs have proven to be safe and efficacious in preclinical models; (b) the vast majority of ligand-targeted PNMs is generated for the treatment of cancer; (c) contribution of targeting ligands to the PNM efficacy is not unambiguously proven; and (d) targeting ligands do not cause localization of the PNM within the target tissue, but rather provide benefits in terms of target cell internalization and target tissue retention once the PNM has arrived at the target site. Increased understanding of the in vivo fate and interactions of the ligand-targeted PNMs with proteins and cells in the human body is mandatory to rationally advance the clinical translation of ligand-targeted PNMs. Future perspectives for ligand-targeted PNM approaches include the delivery of drugs that are unable or inefficient in passing cellular membranes, treatment of drug resistant tumors, targeting of the tumor blood supply, the generation of targeted vaccines and nanomedicines that are able to cross the blood-brain barrier.

  13. Evaluation of undergraduate nursing students' clinical confidence following a mental health recovery camp.

    PubMed

    Cowley, Thomas; Sumskis, Sue; Moxham, Lorna; Taylor, Ellie; Brighton, Renee; Patterson, Chris; Halcomb, Elizabeth

    2016-02-01

    In the present study, we evaluate the impact of participation in a mental health recovery camp on the clinical confidence of undergraduate nursing students in dealing with individuals with mental illness. Twenty undergraduate nursing students who participated in the recovery camp completed the Mental Health Nursing Clinical Confidence Scale both before and directly after attending the camp. Data were analysed using descriptive and inferential statistics. Participation in the recovery camp was associated with a statistically-significant increase in students' level of overall confidence between the pretest and post-test data (P < 0.005). The results also demonstrated that students over the age of 25 years and who do not have a family history of mental illness are more likely to self-report a higher level of confidence in both the pre- and post-results. The clinical confidence of undergraduate nursing students improved through participation in an immersive clinical experience within the recovery camp.

  14. The Alpha Stem Cell Clinic: A Model for Evaluating and Delivering Stem Cell-Based Therapies

    PubMed Central

    DeWitt, Natalie D.; Feigal, Ellen G.

    2012-01-01

    Summary Cellular therapies require the careful preparation, expansion, characterization, and delivery of cells in a clinical environment. There are major challenges associated with the delivery of cell therapies and high costs that will limit the companies available to fully evaluate their merit in clinical trials, and will handicap their application at the present financial environment. Cells will be manufactured in good manufacturing practice or near-equivalent facilities with prerequisite safety practices in place, and cell delivery systems will be specialized and require well-trained medical and nursing staff, technicians or nurses trained to handle cells once delivered, patient counselors, as well as statisticians and database managers who will oversee the monitoring of patients in relatively long-term follow-up studies. The model proposed for Alpha Stem Cell Clinics will initially use the capacities and infrastructure that exist in the most advanced tertiary medical clinics for delivery of established bone marrow stem cell therapies. As the research evolves, they will incorporate improved procedures and cell preparations. This model enables commercialization of medical devices, reagents, and other products required for cell therapies. A carefully constructed cell therapy clinical infrastructure with the requisite scientific, technical, and medical expertise and operational efficiencies will have the capabilities to address three fundamental and critical functions: 1) fostering clinical trials; 2) evaluating and establishing safe and effective therapies, and 3) developing and maintaining the delivery of therapies approved by the Food and Drug Administration, or other regulatory agencies. PMID:23197634

  15. The Clinical, Radiographic and Histological evaluation of three different concentrations of Formocresol as a pulpotomy agent

    PubMed Central

    Goyal, Swati; Abuwala, Tasnima; Joshi, Keyur; Mehta, Jahnvi; Indushekar, K R; Hallikerimath, Seema

    2014-01-01

    Background: Formocresol, though the center of much controversy is still the most widely used medicament for primary teeth pulpotomy and an intracanal medicament which has undergone a lengthy evolution to shorten the formocresol application time and reduce the concentration of formocresol exposure to the pulp tissue. Hence, the determination of the actual effective dose and concentration of formocresol for clinical application in primary teeth is an important area of research and a thorough clinical, radiographic and histological investigation in human subjects is very much needed. Materials & Methods: The study was conducted on 45 primary molars for the Clinical, Radiographic study and 45 premolars orthodontically indicated for extraction for the Histological study. The samples were randomly and equally divided into 3 groups of 15 each for pulpotomy with full strength formocresol, 1:5 diluted formocresol and 1:25 diluted formocresol respectively. The pulpotomized primary molars were clinically evaluated at 1st, 3rd, 6th and 9th month while the pulpotomized premolars were subjected for histological evaluation after extraction. Results: Obtained by chi-square test revealed that all the pulpotomized primary molars were asymptomatic till the end of the study period; suggesting 100% clinical and radiographic success while histologically, the three concentrations of formocresol showed decreased severity of fixation of the pulp tissue with decreasing concentration of formocresol. Conclusion: It can be inferred that the diluted formulations (1:5 and 1:25) of formocresol are equally efficient when compared to full-strength formocresol and thus, can be recommended for pulpotomy in primary teeth. How to cite the article: Goyal S, Abuwala T, Joshi K, Mehta J, Indushekar KR, Hallikerimath S. The Clinical, Radiographic and Histological evaluation of three different concentrations of Formocresol as a pulpotomy agent. J Int Oral Health 2014;6(2):118-25. PMID:24876712

  16. Omega-3 fatty acids and inflammation: a perspective on the challenges of evaluating efficacy in clinical research.

    PubMed

    Skulas-Ray, Ann C

    2015-01-01

    Chronic inflammation is a common underpinning of many diseases. There is a strong pre-clinical evidence base demonstrating the efficacy of omega-3 fatty acids for ameliorating inflammation and thereby reducing disease burden. Clinically, C-reactive protein (CRP) serves as both a reliable marker for monitoring inflammation and a modifiable endpoint for studies of anti-inflammatory pharmaceuticals. However, clinical omega-3 fatty acid supplementation trials have not replicated pre-clinical findings in terms of consistent CRP reductions. Methodological differences present numerous challenges in translating pre-clinical evidence to clinical results. It is crucial that future clinical nutrition research clearly distinguish between the reversal of established inflammation and preventing the development of inflammation. Future clinical studies evaluating the ability of omega-3 fatty acids to attenuate an excessive inflammatory response, may be advanced by employing new statistical approaches and utilizing models of induced inflammation, such as low-dose human endotoxemia.

  17. Multicenter phase II clinical trial of nilotinib for patients with imatinib-resistant or -intolerant chronic myeloid leukemia from the East Japan CML study group evaluation of molecular response and the efficacy and safety of nilotinib

    PubMed Central

    2014-01-01

    Background Nilotinib is a second-generation tyrosine kinase inhibitor that exhibits significant efficacy as first- or second-line treatment in patients with chronic myeloid leukemia (CML). We conducted a multicenter Phase II Clinical Trial to evaluate the safety and efficacy of nilotinib among Japanese patients with imatinib-resistant or -intolerant CML-chronic phase (CP) or accelerated phase (AP). Results We analyzed 49 patients (33 imatinib-resistant and 16 imatinib-intolerant) treated with nilotinib 400 mg twice daily. The major molecular response (MMR) rate was 47.8% at 12 months among 35 patients who did not demonstrate an MMR at study entry. Somatic BCR-ABL1 mutations (Y253H, I418V, and exon 8/9 35-bp insertion [35INS]) were detected in 3 patients at 12 months or upon discontinuation of nilotinib. Although 75.5% of patients were still being treated at 12 months, nilotinib treatment was discontinued because of progressing disease in 1 patient, insufficient effect in 2, and adverse events in 9. There was no statistically significant correlation between MMR and trough concentrations of nilotinib. Similarly, no correlation was observed between trough concentrations and adverse events, except for pruritus and hypokalemia. Hyperbilirubinemia was frequently observed (all grades, 51.0%; grades 2–4, 29%; grades 3–4, 4.1%). Hyperbilirubinemia higher than grade 2 was significantly associated with the uridine diphosphate glucuronosyltransferase (UGT)1A9 I399C/C genotype (P = 0.0086; Odds Ratio, 21.2; 95% Confidence Interval 2.2–208.0). Conclusions Nilotinib was efficacious and well tolerated by patients with imatinib-resistant or -intolerant CML-CP/AP. Hyperbilirubinemia may be predicted before nilotinib treatment, and may be controlled by reducing the daily dose of nilotinib in patients with UGT1A9 polymorphisms. Trial registration clinicaltrials.gov: UMIN000002201 PMID:24650752

  18. Influence of microwave disinfection on the linear dimensional stability of complete dentures: a clinical study.

    PubMed

    Basso, Michael Frederico Manzolli; Giampaolo, Eunice Teresinha; Vergani, Carlos Eduardo; Machado, Ana Lúcia; Pavarina, Ana Cláudia; Compagnoni, Marco Antonio

    2010-01-01

    This clinical study evaluated the effect of two microwave disinfection protocols at 650 W for 3 minutes (group 1, once a week; group 2, three times a week) on the linear dimensional stability of complete dentures. Measurements were taken across four reference points: before the first microwave disinfection (baseline) and after each week of disinfection. Furthermore, the dentures were monitored clinically. Group 2 showed significantly greater shrinkage than group 1 in all evaluated weeks. During clinical monitoring, no significant findings were observed. Even though dimensional changes occurred, the clinical evaluation did not yield any changes in either group.

  19. Portfolio as a tool to evaluate clinical competences of traumatology in medical students

    PubMed Central

    Santonja-Medina, Fernando; García-Sanz, M Paz; Martínez-Martínez, Francisco; Bó, David; García-Estañ, Joaquín

    2016-01-01

    This article investigates whether a reflexive portfolio is instrumental in determining the level of acquisition of clinical competences in traumatology, a subject in the 5th year of the degree of medicine. A total of 131 students used the portfolio during their clinical rotation of traumatology. The students’ portfolios were blind evaluated by four professors who annotated the existence (yes/no) of 23 learning outcomes. The reliability of the portfolio was moderate, according to the kappa index (0.48), but the evaluation scores between evaluators were very similar. Considering the mean percentage, 59.8% of the students obtained all the competences established and only 13 of the 23 learning outcomes (56.5%) were fulfilled by >50% of the students. Our study suggests that the portfolio may be an important tool to quantitatively analyze the acquisition of traumatology competences of medical students, thus allowing the implementation of methods to improve its teaching. PMID:26929675

  20. Upper stage technology evaluation studies

    NASA Technical Reports Server (NTRS)

    1972-01-01

    Studies to evaluate advanced technology relative to chemical upper stages and orbit-to-orbit stages are reported. The work described includes: development of LH2/LOX stage data, development of data to indicate stage sensitivity to engine tolerance, modified thermal routines to accommodate storable propellants, added stage geometries to computer program for monopropellant configurations, determination of the relative gain obtainable through improvement of stage mass fraction, future propulsion concepts, effect of ultrahigh chamber-pressure increases, and relative gains obtainable through improved mass fraction.

  1. CFD for evaluation and treatment planning of aneurysms: review of proposed clinical uses and their challenges.

    PubMed

    Chung, Bongjae; Cebral, Juan Raul

    2015-01-01

    Computational fluid dynamics (CFD) has been used for several years to identify mechanical risk factors associated with aneurysmal evolution and rupture as well as to understand flow characteristics before and after surgical treatments in order to help the clinical decision making process. We used the keywords, "CFD" and "aneurysms" to search recent publications since about 2000, and categorized them into (i) studies of rupture risk factors and (ii) investigations of pre- and post-evaluations of surgical treatment with devices like coils and flow diverters (FD). This search enables us to examine the current status of CFD as a clinical tool and to determine if CFD can potentially become an important part of the routine clinical practice for the evaluation and treatment of aneurysms in near future. According to previous reports, it has been argued that CFD has become a quite robust non-invasive tool for the evaluation of surgical devices, especially in the early stages of device design and it has also been applied successfully to the study of rupture risk assessment. However, we find that due to the large number of pre-processing inputs further efforts of validation and reproducibility of CFD with larger clinical datasets are still essential to identify standardized mechanical risk factors. As a result, we identify the following needs to have a robust CFD tool for clinical use: (i) more reliability tests through validation studies, (ii) analyses of larger generalized clinical datasets to find converging universal risk parameters, (iii) fluid structure interaction (FSI) analyses to better understand the detailed vascular remodeling processes associated with aneurysm growth, evolution and rupture, and (iv) better coordinated and organized communications and collaborations between engineers and clinicians.

  2. Prostatitis--clinical and bacterial studies.

    PubMed

    Chandiok, S; Fisk, P G; Riley, V C

    1992-01-01

    Forty men with clinical prostatitis were studied to determine the value of symptomatology and categorization and 30 (75%) were classified as having prostatitis on the basis of prostatic localization studies. Of these 3 (10%) had chronic bacterial prostatitis, 18 (60%) had chronic abacterial prostatitis, and 9 (30%) had prostatodynia. No patient had acute bacterial prostatitis. Although Enterobacteriaciae were isolated from the 3 men with chronic bacterial prostatitis, these bacteria along with Staphlococcus aureus, Streptococcus faecalis, and Chlamydia trachomatis were isolated from a further 6 patients. The mean pH of the expressed prostatic secretion was measured for each group and was found to be 7.6 for those with chronic bacterial prostatitis, 7.1 for chronic abacterial prostatitis, 6.5 for prostatodynia, and 6.9 for those with urethritis suggesting that this test may be of value in the diagnosis of chronic bacterial prostatitis.

  3. Integration and Evaluation of Clinical Decision Support Systems for Diagnosis Idopathics Pulmonary Fibrosis (IPF)

    PubMed Central

    Chae, Youngmoon; Jeon, Sungwan

    2010-01-01

    Objectives The purpose of this study was to develop clinical decision support systems (CDSS) that are integrated with hospital information systems for the differential diagnosis of idiopathic pulmonary fibrosis (IPF). Methods The integrated CDSS were validated and evaluated by physicians. Knowledge modeling for diagnosing IPF was performed by knowledge working groups, composed of radiologists and respiratory specialists. In order to develop the model for CDSS diagnosis, the clinical cases were collected from 290 cases from Seoul National University Hospital and Sevrance Hospital of Yonsei University. For the evaluation of integrated CDSS, interviews were conducted with respiratory specialists and radiologist 2 weeks after applying CDSSs in clinical settings. The CDSS was integrated with the computer vision system (CVS) and diffuse parenchymal lung diseases (DPLD), CDSS developed in our previous project. Results Eighteen cases diagnosed as IPF were applied to the collection of diagnostic knowledge and the refined knowledge, the former diagnosed 1 case (6%) and the latter diagnosed 14 cases (78%). Therefore, the refined knowledge performed better than collected knowledge. The validation results of integrated CDSSs showed that 81 cases (74.3%) were diagnosed correctly. Conclusions There were 109 cases of IPF diagnosed and initiated on treatment. The significance of this study is in developing integrated CDSS with PACS by acquiring and redefining the knowledge needed for IPF diagnosis. In addition, it is significant for the integration of CDSS to verification and clinical evaluation. PMID:21818445

  4. 21 CFR 312.87 - Active monitoring of conduct and evaluation of clinical trials.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... clinical trials. 312.87 Section 312.87 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... and evaluation of clinical trials. For drugs covered under this section, the Commissioner and other agency officials will monitor the progress of the conduct and evaluation of clinical trials and...

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

    PubMed Central

    Helveston, E M

    1980-01-01

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

  6. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

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

  7. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

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

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

    PubMed Central

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

    2015-01-01

    The classification system for categorizing the riskiness of a clinical trial is largely defined by the body of federal regulations known as the Common Rule (45 CFR 46, Subpart A) and by regulations governing the US Food and Drug Administration (FDA) codified in 21 CFR 50. This rule is applied according to the interpretation of institutional review boards (IRBs) charged with overseeing the research. If a clinical trial is determined by an IRB to constitute “minimal risk,” there are important practical implications: the IRB may allow waiver or alteration of the informed consent process; the study may be carried out in certain vulnerable populations; or the study may be reviewed by IRBs using an expedited process. However, it is unclear how the risk levels of pragmatic clinical trials (PCTs) should be assessed. Such trials typically compare existing, widely used medical therapies or interventions in the setting of routine clinical practice. Some of the therapies may be considered risky of themselves but the study comparing them may or may not add to that pre-existing level of risk. In this paper, we examine current research regulations and common interpretations of those regulations and suggest that current interpretation and application of regulations governing minimal-risk classification are marked by a high degree of variability and confusion, which in turn may ultimately harm patients by delaying or hindering potentially beneficial research. We advocate for a clear differentiation between the risks associated with a given therapy and the incremental risk incurred during research evaluating those therapies as a basic principle for evaluating the risk of a clinical study. We then examine two studies that incorporate aspects of PCTs and consider how various factors including patient perspectives, clinical equipoise, practice variation, and research methods such as cluster randomization contribute to current and evolving concepts of minimal risk, and how this

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

    PubMed

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

    2014-12-01

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

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

    PubMed

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

    2014-12-01

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

  11. Clinical and microbiologic studies of genital ulcers in Kenyan women.

    PubMed

    Plummer, F A; D'Costa, L J; Nsanze, H; Karasira, P; MacLean, I W; Piot, P; Ronald, A R

    1985-01-01

    The etiology of genital ulcers in women in tropical regions is poorly understood. Eighty-nine women, presenting to a sexually transmitted disease clinic in Nairobi (Kenya) with a primary complaint of genital ulcers, were evaluated prospectively in a clinical and laboratory study. A final etiologic diagnosis was possible for 60 (67%) of the women. Culture for Haemophilus ducreyi was positive for 43 women, eight had secondary syphilis with ulcerated condyloma latum, three had primary syphilis, one had both chancroid and syphilis, two had moniliasis, two had herpetic ulceration, and one had a traumatic ulcer. The clinical characteristics that best distinguished chancroid from secondary syphilis were ulcer excavation and a rough ulcer base. No etiologic diagnosis was established for 29 patients. However, the clinical and epidemiologic features of these patients suggested that they were similar if not identical to the patients with H. ducreyi culture-positive chancroid. Further studies are necessary to determine the etiology of ulcers in females in whom no pathogen was identified.

  12. Axon clinical chemistry analyzer evaluated according to ECCLS protocol.

    PubMed

    Brenna, S; Prencipe, L

    1992-10-01

    We assessed the analytical performance of the Axon system (Bayer Diagnostici), according to the European Committee for Clinical Laboratory Standards guidelines, for assay of 12 analytes: cholesterol, creatinine, glucose, total protein, urea, uric acid, alkaline phosphatase, alpha-amylase, aspartate aminotransferase, creatine kinase, sodium, and potassium. The field evaluation lasted approximately 5 months and involved the collection of approximately 10,000 data points with the Axon. The following results were obtained: The highest CVs for controls and human sera at different concentration/activity values were 2.2% for within-run imprecision (n = 60; 3 days, pooled estimate) and 3.5% for the between-day imprecision (n = 20 days). Close correlation was found with results for patients' specimens assayed with comparative instruments (Hitachi 717 for substrates and enzymes, Beckman Synchron EL/E4A for electrolytes). No drift was observed during 8 h of operation. The linearity range was broad, sometimes exceeding the manufacturer's claims. No sample-, reagent-, or cuvette-related carryover was found. Measurement of control sera gave results within +/- 5% of the assigned values. We conclude that good reliability and practicability make the Axon system suitable for laboratories with various needs.

  13. Evaluation of Bacterial Contamination in a Clinical Environment

    PubMed Central

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

    2015-01-01

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

  14. An Artificial Neural Network Estimation of Gait Balance Control in the Elderly Using Clinical Evaluations

    PubMed Central

    Lugade, Vipul; Lin, Victor; Farley, Arthur; Chou, Li-Shan

    2014-01-01

    The use of motion analysis to assess balance is essential for determining the underlying mechanisms of falls during dynamic activities. Clinicians evaluate patients using clinical examinations of static balance control, gait performance, cognition, and neuromuscular ability. Mapping these data to measures of dynamic balance control, and the subsequent categorization and identification of community dwelling elderly fallers at risk of falls in a quick and inexpensive manner is needed. The purpose of this study was to demonstrate that given clinical measures, an artificial neural network (ANN) could determine dynamic balance control, as defined by the interaction of the center of mass (CoM) with the base of support (BoS), during gait. Fifty-six elderly adults were included in this study. Using a feed-forward neural network with back propagation, combinations of five functional domains, the number of hidden layers and error goals were evaluated to determine the best parameters to assess dynamic balance control. Functional domain input parameters included subject characteristics, clinical examinations, cognitive performance, muscle strength, and clinical balance performance. The use of these functional domains demonstrated the ability to quickly converge to a solution, with the network learning the mapping within 5 epochs, when using up to 30 hidden nodes and an error goal of 0.001. The ability to correctly identify the interaction of the CoM with BoS demonstrated correlation values up to 0.89 (P<.001). On average, using all clinical measures, the ANN was able to estimate the dynamic CoM to BoS distance to within 1 cm and BoS area to within 75 cm2. Our results demonstrated that an ANN could be trained to map clinical variables to biomechanical measures of gait balance control. A neural network could provide physicians and patients with a cost effective means to identify dynamic balance issues and possible risk of falls from routinely collected clinical examinations

  15. Dissemination of behavioural activation for depression to mental health nurses: training evaluation and benchmarked clinical outcomes.

    PubMed

    Ekers, D M; Dawson, M S; Bailey, E

    2013-03-01

    Depression causes significant distress, disability and cost within the UK. Behavioural activation (BA) is an effective single-strand psychological approach which may lend itself to brief training programmes for a wide range of clinical staff. No previous research has directly examined outcomes of such dissemination. A 5-day training course for 10 primary care mental health workers aiming to increase knowledge and clinical skills in BA was evaluated using the Training Acceptability Rating Scale. Depression symptom level data collected in a randomized controlled trial using trainees were then compared to results from meta-analysis of studies using experienced therapists. BA training was highly acceptable to trainees (94.4%, SD 6%). The combined effect size of BA was unchanged by the addition of the results of this evaluation to those of studies using specialist therapists. BA offers a promising psychological intervention for depression that appears suitable for delivery by mental health nurses following brief training.

  16. Evaluation of obesity clinic program in public community health centers in South Korea.

    PubMed

    Jo, Heui-Sug; Lee, Bo-Young

    2013-07-01

    The purpose of this study was to evaluate the obesity clinic program in the public community health centers in Korea in 2006-2007. The authors conducted a telephone questionnaire survey for participants to evaluate the outcome of the program. Samples were selected through convenient sampling: 30 persons per one public health center among 2560 participants. The level of improvement in obesity, regular exercise, and the effort for calorie reduction of the participants were analyzed. There were significant differences: The participants who were provided continuously the information of obesity clinic program reduced calories for weight loss (odds ratio [OR] = 2.37, 95% confidence interval [CI] = 1.34-4.19, P < .01), and showed concern about body weight (OR = 2.17, 95% CI = 1.07-4.41, P < 0.05). This study found that when the program information was provided continually and the participants were motivated, the community obesity program goals could be achieved.

  17. Clinical studies of styrene workers: initial findings.

    PubMed Central

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

    1976-01-01

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

  18. Oncolysis by paramyxoviruses: preclinical and clinical studies

    PubMed Central

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

    2015-01-01

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

  19. Integrating utilization-focused evaluation with business process modeling for clinical research improvement.

    PubMed

    Kagan, Jonathan M; Rosas, Scott; Trochim, William M K

    2010-10-01

    New discoveries in basic science are creating extraordinary opportunities to design novel biomedical preventions and therapeutics for human disease. But the clinical evaluation of these new interventions is, in many instances, being hindered by a variety of legal, regulatory, policy and operational factors, few of which enhance research quality, the safety of study participants or research ethics. With the goal of helping increase the efficiency and effectiveness of clinical research, we have examined how the integration of utilization-focused evaluation with elements of business process modeling can reveal opportunities for systematic improvements in clinical research. Using data from the NIH global HIV/AIDS clinical trials networks, we analyzed the absolute and relative times required to traverse defined phases associated with specific activities within the clinical protocol lifecycle. Using simple median duration and Kaplan-Meyer survival analysis, we show how such time-based analyses can provide a rationale for the prioritization of research process analysis and re-engineering, as well as a means for statistically assessing the impact of policy modifications, resource utilization, re-engineered processes and best practices. Successfully applied, this approach can help researchers be more efficient in capitalizing on new science to speed the development of improved interventions for human disease.

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

    NASA Astrophysics Data System (ADS)

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

    2015-11-01

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

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

    PubMed

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

    2010-11-13

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

  2. Overview of ethical issues in clinical studies.

    PubMed

    Horowitz, H S

    1978-01-01

    Research in human subjects should be conducted only if the rights and welfare of the participants are protected. Prospective study subjects must be given adequate information about all aspects of a study so that they can make a rationally exercised decision about participation; coercive techniques to solicit participants should not be used. Research in humans may be classified in one of three categories: A. Research on treatment of existing conditions; B. Research on preventive measures; and C. Research other than for treatment or prevention. Different concerns and aspects of informed consent assume particular importance in each category. In research on the treatment of existing conditions, untreated or placebo-treated control groups are rarely justified if the condition is irreversible. In research on preventive methods prospective subjects should be informed of the likelihood of receiving an ineffective treatment, if one or more placebo groups are included. A randomized clinical trial is usually the best design for studies of preventive methods. Nonrandomized designs, that are feasible and statistically valid, may be employed in order to avoid depriving some subjects from receiving effective preventive methods. In social or behavioral research, confidentiality of collected information and privacy of the subject are essential considerations.

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

    PubMed

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

    2016-01-01

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

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

    PubMed

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

    2016-08-18

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

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

    PubMed

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

    2009-07-01

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

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

    PubMed Central

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

    2016-01-01

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

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

    PubMed

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

    2007-10-01

    The prognostic accuracy of exercise testing after myocardial infarction is low, and different models have been proposed to enhance the predictive value for subsequent mortality. This study tested a simple score against 3 established scores. Patients with ST-elevation myocardial infarctions were randomized in the Danish Trial in Acute Myocardial Infarction-2 (DANAMI-2) to either primary percutaneous coronary intervention or fibrinolysis with predischarge exercise testing. Clinical and exercise test data were collected prospectively and were available for 1,115 patients. A simple score was derived, awarding 1 point for history or new signs of heart failure, 1 point for a left ventricular ejection fraction <40%, 1 point for age >65 years in men and age >70 years in women, and 1 point for exercise capacity <5 METs in men and exercise capacity <4 METs in women. This