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Sample records for prospectively collected clinical

  1. DADOS-Prospective: an open source application for Web-based prospective data collection

    Directory of Open Access Journals (Sweden)

    Nguyen Lam

    2006-11-01

    Full Text Available Abstract Background Randomized, prospective trials involving multi-institutional collaboration have become a central part of clinical and translational research. However, data management and coordination of multi-center studies is a complex process that involves developing systems for data collection and quality control, tracking data queries and resolutions, as well as developing communication procedures. We describe DADOS-Prospective, an open-source Web-based application for collecting and managing prospective data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to create new clinical research forms (CRF and supports electronic signatures, but also offers the advantage of containing, in a single environment, raw research data in downloadable spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails. Results Feedback from formal and field usability tests was used to guide the design and development of DADOS-Prospective. To date, DADOS-Prospective has been implemented in five prospective clinical studies at our institution. Four of these studies are still in the CRF creation phase and one study has been entirely launched. Conclusion DADOS-Prospective has significant advantages over existing Web-based data collecting programs. At our institution, it has been demonstrated to be an efficient tool for prospective clinical studies.

  2. Prospect for application of umbilical cord blood to clinical treatment of radiation sickness

    International Nuclear Information System (INIS)

    Jia Tingzhen; Ke Xiaoyan

    1998-01-01

    Objective: To look forward to the prospect for application of umbilical cord blood to clinical treatment of radiation sickness by analyzing the results using umbilical cord blood in laboratory experiments and clinical research. Method: The data on umbilical cord blood published in literature are reviewed. Results: The umbilical blood is rich in hematopoietic stem/progenitor cells, low in immunological activity of lymphocytes, expanded significantly ex vivo under selected culture condition readily available and collected easily. Conclusion: With the above advantages, the prospect for application of umbilical cord blood is encouraging, particularly in the clinical treatment of radiation sickness

  3. Prospective, Multicentre, Nationwide Clinical Data from 600 Cases of Acute Pancreatitis.

    Directory of Open Access Journals (Sweden)

    Andrea Párniczky

    Full Text Available The aim of this study was to analyse the clinical characteristics of acute pancreatitis (AP in a prospectively collected, large, multicentre cohort and to validate the major recommendations in the IAP/APA evidence-based guidelines for the management of AP.Eighty-six different clinical parameters were collected using an electronic clinical research form designed by the Hungarian Pancreatic Study Group.600 adult patients diagnosed with AP were prospectively enrolled from 17 Hungarian centres over a two-year period from 1 January 2013.With respect to aetiology, biliary and alcoholic pancreatitis represented the two most common forms of AP. The prevalence of biliary AP was higher in women, whereas alcoholic AP was more common in men. Hyperlipidaemia was a risk factor for severity, lack of serum enzyme elevation posed a risk for severe AP, and lack of abdominal pain at admission demonstrated a risk for mortality. Abdominal tenderness developed in all the patients with severe AP, while lack of abdominal tenderness was a favourable sign for mortality. Importantly, lung injury at admission was associated with mortality. With regard to laboratory parameters, white blood cell count and CRP were the two most sensitive indicators for severe AP. The most common local complication was peripancreatic fluid, whereas the most common distant organ failure in severe AP was lung injury. Deviation from the recommendations in the IAP/APA evidence-based guidelines on fluid replacement, enteral nutrition and timing of interventions increased severity and mortality.Analysis of a large, nationwide, prospective cohort of AP cases allowed for the identification of important determinants of severity and mortality. Evidence-based guidelines should be observed rigorously to improve outcomes in AP.

  4. A prospective picture collection study for a grading atlas of radiation dermatitis for clinical trials in head-and-neck cancer patients

    International Nuclear Information System (INIS)

    Zenda, Sadamoto; Ota, Yosuke; Tachibana, Hiroyuki; Ogawa, Hirofumi; Ishii, Shinobu; Hashiguchi, Chikako; Akimoto, Tetsuo; Ohe, Yuichiro; Uchitomi, Yosuke

    2016-01-01

    Radiation dermatitis is one of the most common acute toxicities of both radiotherapy and chemoradiotherapy. Many clinical trials have evaluated the level of toxicity using the Common Terminology Criteria for Adverse Events ver. 4.03. This criterion accounts for severity in a single sentence only, and no visual classification guide has been available. Thus, there is a risk of subjective interpretation by the individual investigator. This contrasts with the situation with hematologic toxicities, which can be interpreted objectively. The aim of this prospective picture collection study was to develop a grading tool for use in establishing the severity of radiation dermatitis in clinical trials. A total of 118 patients who were scheduled to receive definitive or postoperative radiotherapy or chemoradiotherapy were enrolled from the four participating cancer centers. All researchers in our group used the same model of camera under the same shooting conditions to maintain consistent photographic quality. In all, 1600 photographs were collected. Of these, 100 photographs qualified for the first round of selection and were then graded by six experts, basically in accordance with the CTCAE ver. 4.03 (JCOG ver. in Japanese). After further study, 38 photographs were selected as representing typical models for Grade 1–4 radiation dermatitis; the radiation dermatitis grading atlas was produced from these photographs. The atlas will play a major role in ensuring that the dermatitis rating system is consistent between the institutions participating in trials. We hope that this will contribute to improving the quality of clinical trials, and also to improving the level of routine clinical practice

  5. BRIEF REPORT: Beyond Clinical Experience: Features of Data Collection and Interpretation That Contribute to Diagnostic Accuracy

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    Nendaz, Mathieu R; Gut, Anne M; Perrier, Arnaud; Louis-Simonet, Martine; Blondon-Choa, Katherine; Herrmann, François R; Junod, Alain F; Vu, Nu V

    2006-01-01

    BACKGROUND Clinical experience, features of data collection process, or both, affect diagnostic accuracy, but their respective role is unclear. OBJECTIVE, DESIGN Prospective, observational study, to determine the respective contribution of clinical experience and data collection features to diagnostic accuracy. METHODS Six Internists, 6 second year internal medicine residents, and 6 senior medical students worked up the same 7 cases with a standardized patient. Each encounter was audiotaped and immediately assessed by the subjects who indicated the reasons underlying their data collection. We analyzed the encounters according to diagnostic accuracy, information collected, organ systems explored, diagnoses evaluated, and final decisions made, and we determined predictors of diagnostic accuracy by logistic regression models. RESULTS Several features significantly predicted diagnostic accuracy after correction for clinical experience: early exploration of correct diagnosis (odds ratio [OR] 24.35) or of relevant diagnostic hypotheses (OR 2.22) to frame clinical data collection, larger number of diagnostic hypotheses evaluated (OR 1.08), and collection of relevant clinical data (OR 1.19). CONCLUSION Some features of data collection and interpretation are related to diagnostic accuracy beyond clinical experience and should be explicitly included in clinical training and modeled by clinical teachers. Thoroughness in data collection should not be considered a privileged way to diagnostic success. PMID:17105525

  6. Exploring Prospective Teachers’ Reflections in the Context of Conducting Clinical Interviews

    Directory of Open Access Journals (Sweden)

    Rukiye Didem Taylan

    2018-04-01

    Full Text Available This study investigated prospective mathematics teachers’ reflections on the experience of designing and conducting one-to-one clinical interviews with middle school students in the context of an elective course on use of video in teacher learning. Prospective teachers were asked to write about weaknesses and strengths in student understanding as well as their own performance as an interviewer in terms of asking questions and responding to student thinking in their reflections on conducting clinical interviews. Furthermore, prospective teachers were also asked to reflect on what they would do differently in order to conduct better clinical interviews. Nature of prospective teachers’ reflections were analyzed by using existing frameworks (through constructs of reflection-on-action and reflection-for-action and by using thematic analysis. Results of data analyses revealed that prospective teachers had more difficulties in providing meaningful reflection-for-action which was related to alternative decisions and planning for future similar interviews. Thematic analysis results revealed prospective teachers’ learning were grouped under three categories: conducting clinical interviews as part of being a teacher, complexity of conducting clinical interviews, and personal theories about middle school students. There are implications for both teacher learning and research.

  7. Discordance in histopathologic evaluation of melanoma sentinel lymph node biopsy with clinical follow-up: results from a prospectively collected database.

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    Dandekar, Monisha; Lowe, Lori; Fullen, Douglas R; Johnson, Timothy M; Sabel, Michael S; Wong, Sandra L; Patel, Rajiv M

    2014-10-01

    Sentinel lymph node (SLN) status currently represents the single most important prognostic factor in clinically localized melanoma and is widely used in patients with melanoma at significant risk for nodal micrometastasis. Although several studies have looked at the rates and implications of inaccuracies in the histopathologic diagnosis of melanocytic lesions, accuracy in the histologic interpretation of the SLN in melanoma has not been addressed. The goal of this study was to determine the rates of discordance in the histopathologic evaluation of the SLN and the potential clinical impact on patients referred to a comprehensive melanoma center. A prospectively collected database was queried for melanoma patients who had SLN biopsies performed at outside institutions before referral to the University of Michigan Multidisciplinary Melanoma Program between 2006 and 2009. These cases were reviewed and clinical follow-up obtained. After internal review of the SLN material, 13 (8 %) of 167 cases had major discrepancies in diagnosis that impacted patient management and prognosis. The disease of five patients was subsequently downstaged and the disease of eight patients was upstaged after internal review of the SLNs and reversal in diagnoses. There appears to be a small yet significant rate of discordance in diagnosis of the SLN for melanoma after expert histopathologic review. The implications of this discordance and revision of diagnosis is substantial. Expert histopathologic review of the SLN warrants consideration to provide the most accurate prognostic information and optimal patient care.

  8. Course of Tourette Syndrome and Comorbidities in a Large Prospective Clinical Study

    DEFF Research Database (Denmark)

    Groth, Camilla; Mol Debes, Nanette; Rask, Charlotte Ulrikka

    2017-01-01

    Objective: Tourette syndrome (TS) is a childhood-onset neurodevelopmental disorder characterized by tics and frequent comorbidities. Although tics often improve during adolescence, recent studies suggest that comorbid obsessive-compulsive disorder (OCD) and attention-deficit/hyperactivity disorder...... (ADHD) tend to persist. This large prospective follow-up study describes the clinical course of tics and comorbidities during adolescence and the prevalence of coexisting psychopathologies. Method: The clinical cohort was recruited at the Danish National Tourette Clinic, and data were collected...... at baseline (n = 314, age range 5–19 years) and at follow-up 6 years later (n = 227) to establish the persistence and severity of tics and comorbidities. During follow-up, the Development and Well-Being Assessment (DAWBA) was used to diagnose coexisting psychopathologies. Repeated measures of severity scores...

  9. Telemedicine in a pediatric headache clinic: A prospective survey.

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    Qubty, William; Patniyot, Irene; Gelfand, Amy

    2018-05-08

    The aim of this prospective study was to survey our patients about their experience with our clinic's telemedicine program to better understand telemedicine's utility for families, and to improve patient satisfaction and ultimately patient care. This was a prospective survey study of patients and their families who had a routine telemedicine follow-up visit with the University of California San Francisco Pediatric Headache Program. The survey was administered to patients and a parent(s) following their telemedicine visit. Fifty-one of 69 surveys (74%) were completed. All (51/51) patients and families thought that (1) telemedicine was more convenient compared to a clinic visit, (2) telemedicine caused less disruption of their daily routine, and (3) they would choose to do telemedicine again. The mean round-trip travel time from home to clinic was 6.8 hours (SD ± 8.6 hours). All participants thought telemedicine was more cost-effective than a clinic visit. Parents estimated that participating in a telemedicine visit instead of a clinic appointment saved them on average $486. This prospective, pediatric headache telemedicine study shows that telemedicine is convenient, perceived to be cost-effective, and patient-centered. Providing the option of telemedicine for routine pediatric headache follow-up visits results in high patient and family satisfaction. © 2018 American Academy of Neurology.

  10. A Prospective, Randomized, Double-blind Clinical Trial of One Nano ...

    African Journals Online (AJOL)

    2015-12-16

    Dec 16, 2015 ... prospective randomized clinical trial that evaluated the clinical performance of one high‑viscosity bulk‑fill composite resin in Class II cavities of posterior teeth. .... amount of glass ionomer needed was used to cover the calcium ...

  11. 78 FR 77137 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

    Science.gov (United States)

    2013-12-20

    .... Information Collection Request Title: Black Lung Clinics Program Performance Measures OMB No. 0915-xxxx--New... an annual data collection of user information for the Black Lung Program, which has been ongoing with... the needs of the nation's coal miners are met. Likely Respondents: Current and prospective Black Lung...

  12. Feasibility of Collecting Vulvar Pain Variability and Its Correlates Using Prospective Collection with Smartphones

    Directory of Open Access Journals (Sweden)

    Ruby H. N. Nguyen

    2014-01-01

    Full Text Available Context. Vulvar pain level may fluctuate in women with vulvodynia even in the absence of therapy; however, there is little evidence suggesting which factors may be associated with variability. Objective. Determine the feasibility of using smartphones to collect prospective data on vulvar pain and factors that may influence vulvar pain level. Methods. 24 clinically confirmed women were enrolled from a population-based study and asked to answer five questions using their smartphones each week for one month. Questions assessed vulvar pain level (0–10, presence of pain upon wakening, pain elsewhere in their body, treatment use, and intercourse. Results. Women completed 100% of their scheduled surveys, with acceptability measures highly endorsed. Vulvar pain ratings had a standard deviation within women of 1.6, with greater variation on average among those with higher average pain levels (P<0.001. On the weeks when a woman reported waking with pain, her vulvar pain level was higher by 1.82 on average (P<0.001. Overall, average vulvar pain level was not significantly associated with the frequency of reporting other body pains (P=0.64. Conclusion. Our smartphone tracking system promoted excellent compliance with weekly tracking of factors that are otherwise difficult to recall, some of which were highly associated with vulvar pain level.

  13. A prospective, randomized, double-blind clinical trial of one nano ...

    African Journals Online (AJOL)

    Abstract. Background: Recently, manufacturers have introduced bulk‑fill composite resins that reportedly can be placed in increments of 4 mm or greater. Objective: The purpose of this article was to report the results of 12 months prospective randomized clinical trial that evaluated the clinical performance of one ...

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

    DEFF Research Database (Denmark)

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

    2015-01-01

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

  15. 3D laparoscopic surgery: a prospective clinical trial.

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    Agrusa, Antonino; Di Buono, Giuseppe; Buscemi, Salvatore; Cucinella, Gaspare; Romano, Giorgio; Gulotta, Gaspare

    2018-04-03

    Since it's introduction, laparoscopic surgery represented a real revolution in clinical practice. The use of a new generation three-dimensional (3D) HD laparoscopic system can be considered a favorable "hybrid" made by combining two different elements: feasibility and diffusion of laparoscopy and improved quality of vision. In this study we report our clinical experience with use of three-dimensional (3D) HD vision system for laparoscopic surgery. Between 2013 and 2017 a prospective cohort study was conducted at the University Hospital of Palermo. We considered 163 patients underwent to laparoscopic three-dimensional (3D) HD surgery for various indications. This 3D-group was compared to a retrospective-prospective control group of patients who underwent the same surgical procedures. Considerating specific surgical procedures there is no significant difference in term of age and gender. The analysis of all the groups of diseases shows that the laparoscopic procedures performed with 3D technology have a shorter mean operative time than comparable 2D procedures when we consider surgery that require complex tasks. The use of 3D laparoscopic technology is an extraordinary innovation in clinical practice, but the instrumentation is still not widespread. Precisely for this reason the studies in literature are few and mainly limited to the evaluation of the surgical skills to the simulator. This study aims to evaluate the actual benefits of the 3D laparoscopic system integrating it in clinical practice. The three-dimensional view allows advanced performance in particular conditions, such as small and deep spaces and promotes performing complex surgical laparoscopic procedures.

  16. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs is yet unclear.To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs. NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14% versus 78/288 (27%, p<0.001, missing data excluded. Poor recruitment was the most frequent reason for discontinuation in both NPSs (36% and RCTs (37%.Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

  17. Quality of optometry referrals to neovascular age-related macular degeneration clinic: a prospective study

    OpenAIRE

    Muen, Wisam J; Hewick, Simon A

    2011-01-01

    Objectives To evaluate the quality of referrals to a neovascular age-related macular degeneration clinic from optometrists using the standard Rapid Access Referral Form (RARF) from the Royal College of Ophthalmologists. Design A prospective study. Prospective data were gathered from all optometry referrals using the RARF, between the periods of December 2006 to August 2009. These were assessed for accuracy of history, clinical signs and final diagnosis as compared to a macula expert. Setting ...

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

    Science.gov (United States)

    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. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  19. Failure to Thrive: A Prospective Study in a Pediatric Gastroenterology Clinic.

    Science.gov (United States)

    Larson-Nath, Catherine M; Goday, Praveen S

    2016-06-01

    We aimed to describe the clinical characteristics, diagnostic work-up, interventions, and outcomes of children referred to a pediatric gastroenterology clinic with the diagnosis of failure to thrive (FTT). We prospectively enrolled 110 children seen for the first time in our pediatric gastroenterology clinic for FTT. Standard demographic information, history, and anthropometric data were collected at initial and follow-up visits. We also obtained data about diagnostic workup, therapeutic interventions, and growth outcomes. Seventy patients (63.6%) were boys with a median age of 0.79 years (interquartile range 0.36-1.98). Of the 91 children with follow-up data, 81 (89%) were found to have nonorganic etiologies of their FTT. The majority of children (56.4%) underwent laboratory evaluation. Imaging and endoscopic evaluations were performed in fewer patients (29.6 and 10.2%, respectively). Endoscopic intervention yielded a diagnosis in 16.7% of patients while the positive result rates for laboratory testing and imaging were 3.2% and 3.1%, respectively. The most common therapeutic interventions included increasing calories (71.8%), avoiding grazing (71.8%), and structuring meals and snacks (67.3%). Compared with nonadherent children, children who were adherent with standard behavioral and nutritional interventions showed a higher positive change in z scores for weight (0.36 vs -0.01, P = 0.001) and body mass index (0.58 vs -0.18, P = 0.031). The majority of children in a pediatric gastroenterology clinic with FTT have nonorganic etiologies of their failure to thrive. Laboratory, imaging, and endoscopic evaluation are rarely positive and should be judiciously performed. Adherence to standardized interventions leads to improved growth.

  20. Interrater reliability and accuracy of clinicians and trained research assistants performing prospective data collection in emergency department patients with potential acute coronary syndrome.

    Science.gov (United States)

    Cruz, Carlos O; Meshberg, Emily B; Shofer, Frances S; McCusker, Christine M; Chang, Anna Marie; Hollander, Judd E

    2009-07-01

    Clinical research requires high-quality data collection. Data collected at the emergency department evaluation is generally considered more precise than data collected through chart abstraction but is cumbersome and time consuming. We test whether trained research assistants without a medical background can obtain clinical research data as accurately as physicians. We hypothesize that they would be at least as accurate because they would not be distracted by clinical requirements. We conducted a prospective comparative study of 33 trained research assistants and 39 physicians (35 residents) to assess interrater reliability with respect to guideline-recommended clinical research data. Immediately after the research assistant and clinician evaluation, the data were compared by a tiebreaker third person who forced the patient to choose one of the 2 answers as the correct one when responses were discordant. Crude percentage agreement and interrater reliability were assessed (kappa statistic). One hundred forty-three patients were recruited (mean age 50.7 years; 47% female patients). Overall, the median agreement was 81% (interquartile range [IQR] 73% to 92%) and interrater reliability was fair (kappa value 0.36 [IQR 0.26 to 0.52]) but varied across categories of data: cardiac risk factors (median 86% [IQR 81% to 93%]; median 0.69 [IQR 0.62 to 0.83]), other cardiac history (median 93% [IQR 79% to 95%]; median 0.56 [IQR 0.29 to 0.77]), pain location (median 92% [IR 86% to 94%]; median 0.37 [IQR 0.25 to 0.29]), radiation (median 86% [IQR 85% to 87%]; median 0.37 [IQR 0.26 to 0.42]), quality (median 85% [IQR 75% to 94%]; median 0.29 [IQR 0.23 to 0.40]), and associated symptoms (median 74% [IQR 65% to 78%]; median 0.28 [IQR 0.20 to 0.40]). When discordant information was obtained, the research assistant was more often correct (median 64% [IQR 53% to 72%]). The relatively fair interrater reliability observed in our study is consistent with previous studies evaluating

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

    International Nuclear Information System (INIS)

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

    2007-01-01

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

  2. Cytologic features of nipple aspirate fluid using an automated non-invasive collection device: a prospective observational study

    Directory of Open Access Journals (Sweden)

    Rowe Leslie R

    2005-08-01

    Full Text Available Abstract Background Detection of cytologic atypia in nipple aspirate fluid (NAF has been shown to be a predictor of risk for development of breast carcinoma. Manual collection of NAF for cytologic evaluation varies widely in terms of efficacy, ease of use, and patient acceptance. We investigated a new automated device for the non-invasive collection of NAF in the office setting. Methods A multi-center prospective observational clinical trial involving asymptomatic women designed to assess fluid production, adequacy, safety and patient acceptance of the HALO NAF Collection System (NeoMatrix, Irvine, CA. Cytologic evaluation of all NAF samples was performed using previously described classification categories. Results 500 healthy women were successfully enrolled. Thirty-eight percent (190/500 produced fluid and 187 were available for cytologic analysis. Cytologic classification of fluid producers showed 50% (93/187 Category 0 (insufficient cellular material, 38% (71/187 Category I (benign non-hyperplastic ductal epithelial cells, 10% (18/187 Category II (benign hyperplastic ductal epithelial cells, 3% (5/187 Category III (atypical ductal epithelial cells and none were Category IV (unequivocal malignancy. Overall, 19% of the subjects produced NAF with adequate cellularity and 1% were found to have cytologic atypia. Conclusion The HALO system is a simple, safe, rapid, automated method for standardized collection of NAF which is acceptable to patients. Cytologic assessment of HALO-collected NAF showed the ability to detect benign and pre-neoplastic ductal epithelial cells from asymptomatic volunteers.

  3. Prospective registration of clinical trials in India: strategies, achievements & challenges.

    Science.gov (United States)

    Tharyan, Prathap

    2009-02-01

    This paper traces the development of the Clinical Trial Registry-India (CTRI) against the backdrop of the inequities in healthcare and the limitations in the design, conduct, regulation, oversight and reporting of clinical trials in India. It describes the scope and goals of the CTRI, the data elements it seeks and the process of registering clinical trials. It reports progress in trial registration in India and discusses the challenges in ensuring that healthcare decisions are informed by all the evidence. A descriptive survey of developments in clinical trial registration in India from publications in the Indian medical literature supplemented by first hand knowledge of these developments and an evaluation of how well clinical trials registered in the CTRI up to 10 January, 2009 comply with the requirements of the CTRI and the World Health Organization's International Clinical Trial Registry (WHO ICTRP). Considerable inequities exist within the Indian health system. Deficiencies in healthcare provision and uneven regulation of, and access to, affordable healthcare co-exists with a large private health system of uneven quality. India is now a preferred destination for outsourced clinical trials but is plagued by poor ethical oversight of the many trial sites and scant information of their existence. The CTRI's vision of conforming to international requirements for transparency and accountability but also using trial registration as a means of improving trial design, conduct and reporting led to the selection of registry-specific dataset items in addition to those endorsed by the WHO ICTRP. Compliance with these requirements is good for the trials currently registered but these trials represent only a fraction of the trials in progress in India. Prospective trial registration is a reality in India. The challenges facing the CTRI include better engagement with key stakeholders to ensure increased prospective registration of clinical trials and utilization of

  4. Incidence, risk factors and clinical course of pancreatic fluid collections in acute pancreatitis.

    Science.gov (United States)

    Cui, Mei Lan; Kim, Kook Hyun; Kim, Ho Gak; Han, Jimin; Kim, Hyunsoo; Cho, Kwang Bum; Jung, Min Kyu; Cho, Chang Min; Kim, Tae Nyeun

    2014-05-01

    Acute pancreatitis is an acute inflammatory process of the pancreas with variable involvement of other regional tissues or remote organ systems. Acute fluid collections and pseudocyst formation are the most frequent complications of acute pancreatitis. The aims of this study were to evaluate the incidence, risk factors, and clinical course of pancreatic fluid collections and pseudocyst formation following acute pancreatitis. A prospective multicenter study was conducted in five participating centers with 302 patients diagnosed with acute pancreatitis from January 2011 to July 2012. The incidence of pancreatic fluid collections and pseudocyst was 42.7 and 6.3 %, respectively. Patients with fluid collections were significantly younger, compared to those without fluid collections (51.5 ± 15.9 vs. 60.4 ± 16.5 years, P = 0.000). The proportion of alcoholic etiology (54.3 %) in patients with fluid collections was significantly higher compared to other etiologies (P = 0.000). C-reactive protein (CRP) (48 h) was significantly higher in patients with fluid collections, compared to patients without fluid collections (39.2 ± 77.4 vs. 15.1 ± 36.2 mg/dL, P = 0.016). LDH (48 h) was significantly higher in patients with pseudocyst formation, compared to patients with complete resolution (1,317.6 ± 706.4 vs. 478.7 ± 190.5 IU/L, P = 0.000). Pancreatic fluid collections showed spontaneous resolution in 69.8 % (90/129) and 84.2 % of the pseudocysts disappeared or decreased in size during follow up. Age, CRP (48 h), and alcohol etiology are risk factors for pancreatic fluid collections. LDH (48 h) appears to be a risk factor for pseudocyst formation. Most pseudocysts showed a decrease in size or spontaneous resolution with conservative management.

  5. Detailed prospective peer review in a community radiation oncology clinic.

    Science.gov (United States)

    Mitchell, James D; Chesnut, Thomas J; Eastham, David V; Demandante, Carlo N; Hoopes, David J

    In 2012, we instituted detailed prospective peer review of new cases. We present the outcomes of peer review on patient management and time required for peer review. Peer review rounds were held 3 to 4 days weekly and required 2 physicians to review pertinent information from the electronic medical record and treatment planning system. Eight aspects were reviewed for each case: 1) workup and staging; 2) treatment intent and prescription; 3) position, immobilization, and simulation; 4) motion assessment and management; 5) target contours; 6) normal tissue contours; 7) target dosimetry; and 8) normal tissue dosimetry. Cases were marked as, "Meets standard of care," "Variation," or "Major deviation." Changes in treatment plan were noted. As our process evolved, we recorded the time spent reviewing each case. From 2012 to 2014, we collected peer review data on 442 of 465 (95%) radiation therapy patients treated in our hospital-based clinic. Overall, 91 (20.6%) of the cases were marked as having a variation, and 3 (0.7%) as major deviation. Forty-two (9.5%) of the cases were altered after peer review. An overall peer review score of "Variation" or "Major deviation" was highly associated with a change in treatment plan (P peer review. Indicators on position, immobilization, simulation, target contours, target dosimetry, motion management, normal tissue contours, and normal tissue dosimetry were significantly associated with a change in treatment plan. The mean time spent on each case was 7 minutes. Prospective peer review is feasible in a community radiation oncology practice. Our process led to changes in 9.5% of cases. Peer review should focus on technical factors such as target contours and dosimetry. Peer review required 7 minutes per case. Published by Elsevier Inc.

  6. Development of an open metadata schema for prospective clinical research (openPCR) in China.

    Science.gov (United States)

    Xu, W; Guan, Z; Sun, J; Wang, Z; Geng, Y

    2014-01-01

    In China, deployment of electronic data capture (EDC) and clinical data management system (CDMS) for clinical research (CR) is in its very early stage, and about 90% of clinical studies collected and submitted clinical data manually. This work aims to build an open metadata schema for Prospective Clinical Research (openPCR) in China based on openEHR archetypes, in order to help Chinese researchers easily create specific data entry templates for registration, study design and clinical data collection. Singapore Framework for Dublin Core Application Profiles (DCAP) is used to develop openPCR and four steps such as defining the core functional requirements and deducing the core metadata items, developing archetype models, defining metadata terms and creating archetype records, and finally developing implementation syntax are followed. The core functional requirements are divided into three categories: requirements for research registration, requirements for trial design, and requirements for case report form (CRF). 74 metadata items are identified and their Chinese authority names are created. The minimum metadata set of openPCR includes 3 documents, 6 sections, 26 top level data groups, 32 lower data groups and 74 data elements. The top level container in openPCR is composed of public document, internal document and clinical document archetypes. A hierarchical structure of openPCR is established according to Data Structure of Electronic Health Record Architecture and Data Standard of China (Chinese EHR Standard). Metadata attributes are grouped into six parts: identification, definition, representation, relation, usage guides, and administration. OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data

  7. Building sustainable multi-functional prospective electronic clinical data systems.

    Science.gov (United States)

    Randhawa, Gurvaneet S; Slutsky, Jean R

    2012-07-01

    A better alignment in the goals of the biomedical research enterprise and the health care delivery system can help fill the large gaps in our knowledge of the impact of clinical interventions on patient outcomes in the real world. There are several initiatives underway to align the research priorities of patients, providers, researchers, and policy makers. These include Agency for Healthcare Research and Quality (AHRQ)-supported projects to build flexible prospective clinical electronic data infrastructure that meet the needs of these diverse users. AHRQ has previously supported the creation of 2 distributed research networks as a new approach to conduct comparative effectiveness research (CER) while protecting a patient's confidential information and the proprietary needs of a clinical organization. It has applied its experience in building these networks in directing the American Recovery and Reinvestment Act funds for CER to support new clinical electronic infrastructure projects that can be used for several purposes including CER, quality improvement, clinical decision support, and disease surveillance. In addition, AHRQ has funded a new Electronic Data Methods forum to advance the methods in clinical informatics, research analytics, and governance by actively engaging investigators from the American Recovery and Reinvestment Act-funded projects and external stakeholders.

  8. The fate of prospective spine studies registered on www.ClinicalTrials.gov.

    Science.gov (United States)

    Ohnmeiss, Donna D

    2015-03-01

    There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by

  9. Prospective Lymphedema Surveillance in a Clinic Setting

    Directory of Open Access Journals (Sweden)

    Janet Chance-Hetzler

    2015-08-01

    Full Text Available The potential impact of breast cancer-related lymphedema (LE is quite extensive, yet it often remains under-diagnosed until the later stages. This project examines the effectiveness of prospective surveillance in post-surgical breast cancer patients. A retrospective analysis of 49 out of 100 patients enrolled in a longitudinal prospective study at a Midwestern breast center evaluates: (1 time required for completion of bilateral limb measurements and Lymphedema Breast Cancer Questionnaire (LBCQ; (2 referral to LE management with limb volume increase (LVI and/or LBCQ symptoms; and (3 cost of LE management at lower LVI (≥5%–≤10% versus traditional (≥10%. Findings revealed a visit timeframe mean of 40.3 min (range = 25–60; 43.6% of visits were ≤30-min timeframe. Visit and measurement times decreased as clinic staff gained measurement experience; measurement time mean was 17.9 min (range = 16.9–18.9. LBCQ symptoms and LVI were significantly (p < 0.001 correlated to LE referral; six of the nine patients referred (67% displayed both LBCQ symptoms/LVI. Visits with no symptoms reported did not result in referral, demonstrating the importance of using both indicators when assessing early LE. Lower threshold referral provides compelling evidence of potential cost savings over traditional threshold referral with reported costs of: $3755.00 and $6353.00, respectively (40.9% savings.

  10. Arterial blood gases during and their dynamic changes after cardiopulmonary resuscitation: A prospective clinical study.

    Science.gov (United States)

    Spindelboeck, Walter; Gemes, Geza; Strasser, Christa; Toescher, Kathrin; Kores, Barbara; Metnitz, Philipp; Haas, Josef; Prause, Gerhard

    2016-09-01

    An arterial blood gas analysis (ABG) yields important diagnostic information in the management of cardiac arrest. This study evaluated ABG samples obtained during out-of-hospital cardiopulmonary resuscitation (OHCPR) in the setting of a prospective multicenter trial. We aimed to clarify prospectively the ABG characteristics during OHCPR, potential prognostic parameters and the ABG dynamics after return of spontaneous circulation (ROSC). ABG samples were collected and instantly processed either under ongoing OHCPR performed according to current advanced life support guidelines or immediately after ROSC and data ware entered into a case report form along with standard CPR parameters. During a 22-month observation period, 115 patients had an ABG analysis during OHCPR. In samples obtained under ongoing CPR, an acidosis was present in 98% of all cases, but was mostly of mixed hypercapnic and metabolic origin. Hypocapnia was present in only 6% of cases. There was a trend towards higher paO2 values in patients who reached sustained ROSC, and a multivariate regression analysis revealed age, initial rhythm, time from collapse to CPR initiation and the arterio-alveolar CO2 difference (AaDCO2) to be associated with sustained ROSC. ABG samples drawn immediately after ROSC demonstrated higher paO2 and unaltered pH and base excess levels compared with samples collected during ongoing CPR. Our findings suggest that adequate ventilation and oxygenation deserve more research and clinical attention in the management of cardiac arrest and that oxygen uptake improves within minutes after ROSC. Hyperventilation resulting in arterial hypocapnia is not a major problem during OHCPR. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  11. 77 FR 35407 - Proposed Collection; Comment Request: Clinical Mythteries: A Video Game About Clinical Trials

    Science.gov (United States)

    2012-06-13

    ...In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Clinical Mythteries: A Video Game About Clinical Trials. Type of Information Collection Request: NEW. Need and Use of Information Collection: New England Research Institutes as a contractor for the National Heart Lung and Blood Institute is planning to create an engaging, informational ``serious video game'' for adolescents about clinical studies which: (1) Incorporates core learning objectives; and (2) dispels misconceptions. Two types of information collection are planned: usability testing to understand game-play/usability. This information will be collected by focus group and will be digitally recorded 90 minute groups. A pre/post randomized trial to measure change in knowledge. This information will be collected electronically through on-line questionnaire. The game will be incorporated with a larger initiative to provide information about clinical research (http://www.nhlbi.nih.gov/ childrenandclinicalstudies/index.php). Frequency of Response: Once. Affected Public: Individuals. Type of Respondents: Adolescents--aged 8- 14. The annual reporting burden is as follows: Estimated Number of Respondents: 6,148; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: 1.321; and Estimated Total Annual Burden Hours Requested: 370. The annualized cost to respondents is estimated at: $3,700. There are no Capital Costs to report. The Operating Costs to collect this information is estimated at $38,642.

  12. Prospective multicenter survey on the clinical management of pediatric contact dermatitis.

    Science.gov (United States)

    Ruggiero, Giuseppe; Carnevale, Claudia; Diociaiuti, Andrea; Arcangeli, Fabio; El Hachem, May

    2016-12-01

    Contact dermatitis can be defined as an inflammatory process affecting the skin surface and induced by contact with chemical, physical and/or biotic agents in the environment. It causes lesions to skin, mucosae and semi-mucosae by means of allergic and irritant pathogenic mechanisms. Among the main triggers of contact dermatitis in the pediatric age are chemical or physical agents, which cause irritant contact dermatitis (ICD), and sensitizers, which cause a tissue damage through an allergic mechanism (allergic contact dermatitis [ACD]). A prospective, multicenter, observational study was carried out in 204 children affected by contact dermatitis, aged up to 14 years, and enrolled by pediatricians from 7 different Italian provinces. The diagnosis of contact dermatitis was based on the pediatrician's clinical evaluation. The data were collected through a series of simple and multiple choice questions, anonymously filled out by pediatricians. In 90% of cases (184 of 204 patients), there was complete remission of contact dermatitis, with no cases of worsening. No adverse events were observed, either. The effectiveness of the therapy was rated as "very effective" by 84.4% of the parents and 86.8% of the pediatricians. In only 10 patients a new therapy had to be prescribed. Contact dermatitis is a heterogeneous inflammatory skin disease induced by contact with different kinds of environmental agents. Cutaneous manifestations are highly variable and depend on the modality of contact, on the causative agent and on the pathogenesis. This Italian experience of a clinical approach to contact dermatitis stresses the need of daily skin care through different therapeutic strategies, based on the diagnosis, the clinical severity and the parents and children compliance. The first therapeutic measure to be implemented is prevention, through the removal of the causative agent and the use of protective devices. Indeed, preserving the skin's barrier function is an important goal and

  13. Markers of neuroinflammation and neuronal injury in bipolar disorder: Relation to prospective clinical outcomes.

    Science.gov (United States)

    Isgren, Anniella; Sellgren, Carl; Ekman, Carl-Johan; Holmén-Larsson, Jessica; Blennow, Kaj; Zetterberg, Henrik; Jakobsson, Joel; Landén, Mikael

    2017-10-01

    Neuroimmune mechanisms have been linked to the pathophysiology of bipolar disorder based on studies of biomarkers in plasma, cerebrospinal fluid (CSF), and postmortem brain tissue. There are, however, no longitudinal studies investigating if CSF markers of neuroinflammation and neuronal injury predict clinical outcomes in patients with bipolar disorder. We have in previous studies found higher CSF concentrations of interleukin-8 (IL-8), monocyte chemoattractant protein 1 (MCP-1/CCL-2), chitinase-3-like protein 1 (CHI3L1/YKL-40), and neurofilament light chain (NF-L) in euthymic patients with bipolar disorder compared with controls. Here, we investigated the relationship of these CSF markers of neuroinflammation and neuronal injury with clinical outcomes in a prospective study. 77 patients with CSF analyzed at baseline were followed for 6-7years. Associations of baseline biomarkers with clinical outcomes (manic/hypomanic and depressive episodes, suicide attempts, psychotic symptoms, inpatient care, GAF score change) were investigated. Baseline MCP-1 concentrations were positively associated with manic/hypomanic episodes and inpatient care during follow-up. YKL-40 concentrations were negatively associated with manic/hypomanic episodes and with occurrence of psychotic symptoms. The prospective negative association between YKL-40 and manic/hypomanic episodes survived multiple testing correction. Concentrations of IL-8 and NF-L were not associated with clinical outcomes. High concentrations of these selected CSF markers of neuroinflammation and neuronal injury at baseline were not consistently associated with poor clinical outcomes in this prospective study. The assessed proteins may be involved in adaptive immune processes or reflect a state of vulnerability for bipolar disorder rather than being of predictive value for disease progression. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

    Science.gov (United States)

    Trobos, Margarita; Johansson, Martin Lars; Jonhede, Sofia; Peters, Hanna; Hoffman, Maria; Omar, Omar; Thomsen, Peter; Hultcrantz, Malou

    2018-06-01

    In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm 2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects

  15. High frequency audiometry in prospective clinical research of ototoxicity due to platinum derivatives

    NARCIS (Netherlands)

    van der Hulst, R. J.; Dreschler, W. A.; Urbanus, N. A.

    1988-01-01

    The results of clinical use of routine high frequency audiometry in monitoring the ototoxic side effects of platinum and its derivatives are described in this prospective study. After demonstrating the reproducibility of the technique, we discuss the first results of an analysis of ototoxic side

  16. Gender effect on clinical features of achalasia: a prospective study

    Directory of Open Access Journals (Sweden)

    Mahdavinia Mahboobeh

    2006-04-01

    Full Text Available Abstract Background Achalasia is a well-characterized esophageal motor disorder but the rarity of the disease limits performing large studies on its demographic and clinical features. Methods Prospectively, 213 achalasia patients (110 men and 103 women were enrolled in the study. The diagnosis established by clinical, radiographic, and endoscopic as well as manometry criteria. All patients underwent a pre-designed clinical evaluation before and within 6 months after the treatment. Results Solid dysphagia was the most common clinical symptom in men and women. Chest pain was the only symptom which was significantly different between two groups and was more complained by women than men (70.9% vs. 54.5% P value= 0.03. Although the occurrence of chest pain significantly reduced after treatment in both groups (P Conclusion It seems that chest pain is the distinct symptom of achalasia which is affected by sex as well as age and does not relate to the duration of illness, LESP and the type of treatment achalasia patients receive.

  17. PROSPECT Eligibility and Clinical Outcomes: Results From the Pan-Canadian Rectal Cancer Consortium.

    Science.gov (United States)

    Bossé, Dominick; Mercer, Jamison; Raissouni, Soundouss; Dennis, Kristopher; Goodwin, Rachel; Jiang, Di; Powell, Erin; Kumar, Aalok; Lee-Ying, Richard; Price-Hiller, Julie; Heng, Daniel Y C; Tang, Patricia A; MacLean, Anthony; Cheung, Winson Y; Vickers, Michael M

    2016-09-01

    The PROSPECT trial (N1048) is evaluating the selective use of chemoradiation in patients with cT2N1 and cT3N0-1 rectal cancer undergoing sphincter-sparing low anterior resection. We evaluated outcomes of PROSPECT-eligible and -ineligible patients from a multi-institutional database. Data from patients with locally advanced rectal cancer who received chemoradiation and low anterior resection from 2005 to 2014 were retrospectively collected from 5 Canadian centers. Overall survival, disease-free survival (DFS), recurrence-free survival (RFS), and time to local recurrence (LR) were estimated using the Kaplan-Meier method, and a multivariate analysis was performed adjusting for prognostic factors. A total of 566 (37%) of 1531 patients met the PROSPECT eligibility criteria. Eligible patients were more likely to have better PS (P = .0003) and negative circumferential resection margin (P PROSPECT eligibility was associated with improved DFS (hazard ratio [HR], 0.75; 95% confidence interval [CI], 0.61-0.91), overall survival (HR, 0.73; 95% CI, 0.57-0.95), and RFS (HR, 0.68; 95% CI, 0.54-0.86) in univariate analyses. In multivariate analysis, only RFS remained significantly improved for PROSPECT-eligible patients (HR, 0.75; 95% CI, 0.57-1.00, P = .0499). The 3-year DFS and freedom from LR for PROSPECT-eligible patients were 79.1% and 97.4%, respectively, compared to 71.1% and 96.8% for PROSPECT-ineligible patients. Real-world data corroborate the eligibility criteria used in the PROSPECT study; the criteria identify a subgroup of patients in whom risk of recurrence is lower and in whom selective use of chemoradiation should be actively examined. Copyright © 2016 Elsevier Inc. All rights reserved.

  18. Is Mandatory Prospective Trial Registration Working to Prevent Publication of Unregistered Trials and Selective Outcome Reporting? An Observational Study of Five Psychiatry Journals That Mandate Prospective Clinical Trial Registration.

    Directory of Open Access Journals (Sweden)

    Amelia Scott

    Full Text Available To address the bias occurring in the medical literature associated with selective outcome reporting, in 2005, the International Committee of Medical Journal Editors (ICMJE introduced mandatory trial registration guidelines and member journals required prospective registration of trials prior to patient enrolment as a condition of publication. No research has examined whether these guidelines are impacting psychiatry publications. Our objectives were to determine the extent to which articles published in psychiatry journals adhering to ICMJE guidelines were correctly prospectively registered, whether there was evidence of selective outcome reporting and changes to participant numbers, and whether there was a relationship between registration status and source of funding.Any clinical trial (as defined by ICMJE published between 1 January 2009 and 31 July 2013 in the top five psychiatry journals adhering to ICMJE guidelines (The American Journal of Psychiatry, Archives of General Psychiatry/JAMA Psychiatry, Biological Psychiatry, Journal of the American Academy of Child and Adolescent Psychiatry, and The Journal of Clinical Psychiatry and conducted after July 2005 (or 2007 for two journals was included. For each identified trial, where possible we extracted trial registration information, changes to POMs between publication and registry to assess selective outcome reporting, changes to participant numbers, and funding type.Out of 3305 articles, 181 studies were identified as clinical trials requiring registration: 21 (11.6% were deemed unregistered, 61 (33.7% were retrospectively registered, 37 (20.4% had unclear POMs either in the article or the registry and 2 (1.1% were registered in an inaccessible trial registry. Only 60 (33.1% studies were prospectively registered with clearly defined POMs; 17 of these 60 (28.3% showed evidence of selective outcome reporting and 16 (26.7% demonstrated a change in participant numbers of 20% or more; only 26 (14

  19. 77 FR 48993 - Proposed Collection; Comment Request; The Sister Study: A Prospective Study of the Genetic and...

    Science.gov (United States)

    2012-08-15

    ... Genetic and Environmental Risk Factors for Breast Cancer SUMMARY: In compliance with the requirement of... proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), the... Sister Study: A Prospective Study of the Genetic and Environmental Risk Factors for Breast Cancer. Type...

  20. The Allan Burns mummies: A history and future prospect of an anatomical collection

    Directory of Open Access Journals (Sweden)

    J Lee

    2017-01-01

    Full Text Available Acquiring adequate resources for anatomy education has represented a challenge throughout the discipline's long history. A significant number of collections housed in anatomy departments contain human tissue of unknown provenance with some obtained in morally dubious ways. This paper outlines the history and future prospects of one such anatomical assemblage – the Burns Anatomical Collection, currently housed at the University of Maryland (UM. The collection originally contained more than 1000 anatomically prepared mummified human remains. They were produced by the renowned Scottish anatomist Allan Burns in Glasgow in the late eighteenth and early nineteenth centuries. The prepared cadavers became a commodity and after Burns' death, were acquired by his pupil Granville Pattison, who later sold them to the UM. While the origin of these human remains is unknown, historical data suggests that most of the cadavers for the collection were obtained through grave robbing. While intensely used in anatomy teaching in the nineteenth century, specimens from the collection should now be treated primarily as historical artifacts, appropriate only for teaching medical history and ethics. Other perspectives may include repatriating and reburying the human remains and providing a memorial service. Most importantly, this collection and others similar to it should initiate dialog and reflection on the ethical aspects of the past and present medical practice.

  1. Course of Tourette Syndrome and Comorbidities in a Large Prospective Clinical Study.

    Science.gov (United States)

    Groth, Camilla; Mol Debes, Nanette; Rask, Charlotte Ulrikka; Lange, Theis; Skov, Liselotte

    2017-04-01

    Tourette syndrome (TS) is a childhood-onset neurodevelopmental disorder characterized by tics and frequent comorbidities. Although tics often improve during adolescence, recent studies suggest that comorbid obsessive-compulsive disorder (OCD) and attention-deficit/hyperactivity disorder (ADHD) tend to persist. This large prospective follow-up study describes the clinical course of tics and comorbidities during adolescence and the prevalence of coexisting psychopathologies. The clinical cohort was recruited at the Danish National Tourette Clinic, and data were collected at baseline (n = 314, age range 5-19 years) and at follow-up 6 years later (n = 227) to establish the persistence and severity of tics and comorbidities. During follow-up, the Development and Well-Being Assessment (DAWBA) was used to diagnose coexisting psychopathologies. Repeated measures of severity scores were modeled using mixed effects models. Tic severity declined yearly (0.8 points, CI: 0.58-1.01, on the Yale Global Tic Severity Scale [YGTSS]) during adolescence; 17.7% of participants above age 16 years had no tics, whereas 59.5% had minimal or mild tics, and 22.8% had moderate or severe tics. Similarly, significant yearly declines in severity of both OCD (0.24, CI: 0.09-0.39, on the Yale-Brown Obsessive Compulsive Scale for Adults [Y-BOCS] and Yale-Brown Obsessive Compulsive Scale for Children [CY-BOCS]) and ADHD (0.42, CI: 0.32-0.52, DSM-IV) were recorded. At follow-up, 63.0% of participants had comorbidities or coexistent psychopathologies, whereas 37.0% had pure TS. Severity of tics, OCD, and ADHD were significantly associated with age and declined during adolescence. However, considerable comorbidities and coexisting psychopathologies persist throughout adolescence and require monitoring by clinicians. Copyright © 2017 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

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

    DEFF Research Database (Denmark)

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

    2018-01-01

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

  3. EVERREST prospective study: a 6-year prospective study to define the clinical and biological characteristics of pregnancies affected by severe early onset fetal growth restriction.

    Science.gov (United States)

    Spencer, Rebecca; Ambler, Gareth; Brodszki, Jana; Diemert, Anke; Figueras, Francesc; Gratacós, Eduard; Hansson, Stefan R; Hecher, Kurt; Huertas-Ceballos, Angela; Marlow, Neil; Marsál, Karel; Morsing, Eva; Peebles, Donald; Rossi, Carlo; Sebire, Neil J; Timms, John F; David, Anna L

    2017-01-23

    Fetal growth restriction (FGR) is a serious obstetric condition for which there is currently no treatment. The EVERREST Prospective Study has been designed to characterise the natural history of pregnancies affected by severe early onset FGR and establish a well phenotyped bio-bank. The findings will provide up-to-date information for clinicians and patients and inform the design and conduct of the EVERREST Clinical Trial: a phase I/IIa trial to assess the safety and efficacy of maternal vascular endothelial growth factor (VEGF) gene therapy in severe early onset FGR. Data and samples from the EVERREST Prospective Study will be used to identify ultrasound and/or biochemical markers of prognosis in pregnancies with an estimated fetal weight (EFW) economic impact; psychological impact; neonatal condition, progress and complications; and infant growth and neurodevelopment to 2 years of corrected age in surviving infants. Standardised longitudinal ultrasound measurements are performed, including: fetal biometry; uterine artery, umbilical artery, middle cerebral artery, and ductus venosus Doppler velocimetry; and uterine artery and umbilical vein volume blood flow. Samples of maternal blood and urine, amniotic fluid (if amniocentesis performed), placenta, umbilical cord blood, and placental bed (if caesarean delivery performed) are collected for bio-banking. An initial analysis of maternal blood samples at enrolment is planned to identify biochemical markers that are predictors for fetal or neonatal death. The findings of the EVERREST Prospective Study will support the development of a novel therapy for severe early onset FGR by describing in detail the natural history of the disease and by identifying women whose pregnancies have the poorest outcomes, in whom a therapy might be most advantageous. The findings will also enable better counselling of couples with affected pregnancies, and provide a valuable resource for future research into the causes of FGR. NCT02097667

  4. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed) trials.

    Science.gov (United States)

    Paoloni, Melissa; Webb, Craig; Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E J; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara; Khanna, Chand; Trent, Jeffrey

    2014-01-01

    Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (strategies may aid cancer drug development.

  5. Multidisciplinary Team Contributions Within a Dedicated Outpatient Palliative Radiotherapy Clinic: A Prospective Descriptive Study

    International Nuclear Information System (INIS)

    Pituskin, Edith; Fairchild, Alysa; Dutka, Jennifer; Gagnon, Lori; Driga, Amy; Tachynski, Patty; Borschneck, Jo-Ann; Ghosh, Sunita

    2010-01-01

    Purpose: Patients with bone metastases may experience pain, fatigue, and decreased mobility. Multiple medications for analgesia are often required, each with attendant side effects. Although palliative-intent radiotherapy (RT) is effective in decreasing pain, additional supportive care interventions may be overlooked. Our objective was to describe the feasibility of multidisciplinary assessment of patients with symptomatic bone metastases attending a dedicated outpatient palliative RT clinic. Methods and Materials: Consecutive patients referred for RT for painful bone metastases were screened for symptoms and needs relevant to their medications, nutritional intake, activities of daily living, and psychosocial and spiritual concerns from January 1 to December 31, 2007. Consultations by appropriate team members and resulting recommendations were collected prospectively. Patients who received RT were contacted by telephone 4 weeks later to assess symptom outcomes. Results: A total of 106 clinic visits by 82 individual patients occurred. As determined by screening form responses, the clinical Pharmacist, Occupational Therapist, Registered Dietician and Social Worker were consulted to provide assessments and recommendations within the time constraints presented by 1-day palliative RT delivery. In addition to pain relief, significant improvements in tiredness, depression, anxiety, drowsiness and overall well-being were reported at 4 weeks. Conclusions: Systematic screening of this population revealed previously unmet needs, addressed in the form of custom verbal and written recommendations. Multidisciplinary assessment is associated with a high number of recommendations and decreased symptom distress. Our findings lend strong support to the routine assessment by multiple supportive care professionals for patients with advanced cancer being considered for palliative RT.

  6. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study

    Directory of Open Access Journals (Sweden)

    Kristen Meldi Plasseraud

    2016-01-01

    Full Text Available Uveal melanoma management is challenging due to its metastatic propensity. DecisionDx-UM is a prospectively validated molecular test that interrogates primary tumor biology to provide objective information about metastatic potential that can be used in determining appropriate patient care. To evaluate the continued clinical validity and utility of DecisionDx-UM, beginning March 2010, 70 patients were enrolled in a prospective, multicenter, IRB-approved study to document patient management differences and clinical outcomes associated with low-risk Class 1 and high-risk Class 2 results indicated by DecisionDx-UM testing. Thirty-seven patients in the prospective study were Class 1 and 33 were Class 2. Class 1 patients had 100% 3-year metastasis-free survival compared to 63% for Class 2 (log rank test p=0.003 with 27.3 median follow-up months in this interim analysis. Class 2 patients received significantly higher-intensity monitoring and more oncology/clinical trial referrals compared to Class 1 patients (Fisher’s exact test p=2.1×10-13 and p=0.04, resp.. The results of this study provide additional, prospective evidence in an independent cohort of patients that Class 1 and Class 2 patients are managed according to the differential metastatic risk indicated by DecisionDx-UM. The trial is registered with Clinical Application of DecisionDx-UM Gene Expression Assay Results (NCT02376920.

  7. Clinical and ultrasonographic features associated to response to intraarticular corticosteroid injection. A one year follow up prospective cohort study in knee osteoarthritis patient with joint effusion

    Science.gov (United States)

    Galisteo, Carlos; García-Manrique, María; Navarro, Noemí; Caixàs, Assumpta; Larrosa, Marta; Gratacós, Jordi

    2018-01-01

    Objectives Intraarticular injection is used for pain relief in knee osteoarthritis (OA), but there is not a well defined profile of patient who could get more benefit from it. The purpose of this study was to evaluate the frequency of pain relief at one year after corticosteroids intraarticular injection and to identify clinical factors associated to response in patients with knee osteoarthritis with joint effusion. Methods One-year prospective cohort study of patients with knee OA with joint effusion confirmed by ultrasound. An intraarticular injection was performed following a clinical protocol. Anthropometric measurements, laboratory parameters, clinical severity, ultrasound parameters and radiological severity were collected. Response regarding pain and presence of synovial fluid on ultrasound at one month and at one year were evaluated. Clinical responder were consider in subjects with enough improvement to carry out normal daily activities with pain VASeffusion. PMID:29351562

  8. Prospective study of POLG mutations presenting in children with intractable epilepsy: prevalence and clinical features.

    Science.gov (United States)

    Uusimaa, Johanna; Gowda, Vasantha; McShane, Anthony; Smith, Conrad; Evans, Julie; Shrier, Annie; Narasimhan, Manisha; O'Rourke, Anthony; Rajabally, Yusuf; Hedderly, Tammy; Cowan, Frances; Fratter, Carl; Poulton, Joanna

    2013-06-01

    To assess the frequency and clinical features of childhood-onset intractable epilepsy caused by the most common mutations in the POLG gene, which encodes the catalytic subunit of mitochondrial DNA polymerase gamma. Children presenting with nonsyndromic intractable epilepsy of unknown etiology but without documented liver dysfunction at presentation were eligible for this prospective, population-based study. Blood samples were analyzed for the three most common POLG mutations. If any of the three tested mutations were found, all the exons and the exon-intron boundaries of the POLG gene were sequenced. In addition, we retrospectively reviewed the notes of patients presenting with intractable epilepsy in which we had found POLG mutations. All available clinical data were collected by questionnaire and by reviewing the medical records. We analyzed 213 blood DNA samples from patients fulfilling the inclusion criteria of the prospective study. Among these, five patients (2.3%) were found with one of the three common POLG mutations as homozygous or compound heterozygous states. In addition, three patients were retrospectively identified. Seven of the eight patients had either raised cerebrospinal fluid (CSF) lactate (n = 3) or brain magnetic resonance imaging (MRI) changes (n = 4) at presentation with intractable epilepsy. Three patients later developed liver dysfunction, progressing to fatal liver failure in two without previous treatment with sodium valproate (VPA). Furthermore, it is worth mentioning that one patient presented first with an autism spectrum disorder before seizures emerged. Mutations in POLG are an important cause of early and juvenile onset nonsyndromic intractable epilepsy with highly variable associated manifestations including autistic features. This study emphasizes that genetic testing for POLG mutations in patients with nonsyndromic intractable epilepsies is very important for clinical diagnostics, genetic counseling, and treatment decisions

  9. Short-term Clinical Course of Knee Pain in Children and Adolescents: A Feasibility Study Using Electronic Methods of Data Collection.

    Science.gov (United States)

    Swain, Michael S; Kamper, Steven J; Maher, Chris G; Latimer, Jane; Broderick, Carolyn; McKay, Damien; Henschke, Nicholas

    2017-10-01

    Musculoskeletal disorders, such as knee pain, are common in children and adolescents, but there is a lack of high quality research that evaluates the clinical course of these conditions. The objective of this study was to evaluate the feasibility of conducting a prospective study of children and adolescents with knee pain using electronic methods of data collection. Children and adolescents with knee pain that presented to primary care physiotherapy clinics were enrolled and followed-up on a weekly basis via short messaging service (SMS) until their knee pain had recovered (i.e. two consecutive weeks of no pain). Feasibility was assessed in terms of recruitment, retention and response rates to SMS and an online questionnaire. Baseline and 6-month follow-up measures included pain, disability, physical function, physical activity and health related quality of life. Kaplan-Meier survival analysis was used to estimate the median time to knee pain recovery. Thirty participants (mean age 13.0 ± 2.2 years, 53% boys) were recruited over 26 months. The overall response rate to weekly SMS follow-up was 71.3% (809 received/1135 sent). One third of participants stopped responding to SMS prior to recovery, and these participants typically had a much lower response rate during the time they remained in the study. At 6-month follow-up, 80% of the cohort completed the final online questionnaire, and 29% of participants still reported current knee pain (≥1/10 VAS). The median time for knee pain recovery was 8 weeks (95%CI: 5, 10). Electronic data collection alone seems insufficient to track pain recovery in young people and may need to be supplemented with more traditional data collection methods. Researchers should consider further measures to address slow recruitment rates and high attrition when designing large prospective studies of children and adolescents in the future. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  10. Endoscopic third ventriculostomy in children: prospective, multicenter results from the Hydrocephalus Clinical Research Network.

    Science.gov (United States)

    Kulkarni, Abhaya V; Riva-Cambrin, Jay; Holubkov, Richard; Browd, Samuel R; Cochrane, D Douglas; Drake, James M; Limbrick, David D; Rozzelle, Curtis J; Simon, Tamara D; Tamber, Mandeep S; Wellons, John C; Whitehead, William E; Kestle, John R W

    2016-10-01

    OBJECTIVE Endoscopic third ventriculostomy (ETV) is now established as a viable treatment option for a subgroup of children with hydrocephalus. Here, the authors report prospective, multicenter results from the Hydrocephalus Clinical Research Network (HCRN) to provide the most accurate determination of morbidity, complication incidence, and efficacy of ETV in children and to determine if intraoperative predictors of ETV success add substantially to preoperative predictors. METHODS All children undergoing a first ETV (without choroid plexus cauterization) at 1 of 7 HCRN centers up to June 2013 were included in the study and followed up for a minimum of 18 months. Data, including detailed intraoperative data, were prospectively collected as part of the HCRN's Core Data Project and included details of patient characteristics, ETV failure (need for repeat hydrocephalus surgery), and, in a subset of patients, postoperative complications up to the time of discharge. RESULTS Three hundred thirty-six eligible children underwent initial ETV, 18.8% of whom had undergone shunt placement prior to the ETV. The median age at ETV was 6.9 years (IQR 1.7-12.6), with 15.2% of the study cohort younger than 12 months of age. The most common etiologies were aqueductal stenosis (24.8%) and midbrain or tectal lesions (21.2%). Visible forniceal injury (16.6%) was more common than previously reported, whereas severe bleeding (1.8%), thalamic contusion (1.8%), venous injury (1.5%), hypothalamic contusion (1.5%), and major arterial injury (0.3%) were rare. The most common postoperative complications were CSF leak (4.4%), hyponatremia (3.9%), and pseudomeningocele (3.9%). New neurological deficit occurred in 1.5% cases, with 0.5% being permanent. One hundred forty-one patients had documented failure of their ETV requiring repeat hydrocephalus surgery during follow-up, 117 of them during the first 6 months postprocedure. Kaplan-Meier rates of 30-day, 90-day, 6-month, 1-year, and 2-year failure

  11. The effect of neuromuscular blockade on canine laparoscopic ovariectomy: A double-blinded, prospective clinical trial

    NARCIS (Netherlands)

    van Goethem, B.; van Nimwegen, S.A.; Akkerdaas, L.C.; Murrell, J.C.; Kirpensteijn, J.

    2012-01-01

    The Effect of Neuromuscular Blockade on Canine Laparoscopic Ovariectomy: A Double-Blinded, Prospective Clinical Trial Bart Van Goethem, Diplomate ECVS, Sebastiaan Alexander van Nimwegen, PhD, Ies Akkerdaas, DVM, Joanna Claire Murrell, BVSc., PhD, Diplomate ECVAA, and Jolle Kirpensteijn, PhD,

  12. [Comparison on Endoscopic Hemoclip and Hemoclip Combination Therapy in Non-variceal Upper Gastrointestinal Bleeding Patients Based on Clinical Practice Data: Is There Difference between Prospective Cohort Study and Randomized Study?].

    Science.gov (United States)

    Lee, Su Hyun; Jung, Jin Tae; Lee, Dong Wook; Ha, Chang Yoon; Park, Kyung Sik; Lee, Si Hyung; Yang, Chang Heon; Park, Youn Sun; Jeon, Seong Woo

    2015-08-01

    Endoscopic hemoclip application is an effective and safe method of endoscopic hemostasis. We conducted a multicenter retrospective study on hemoclip and hemoclip combination therapy based on prospective cohort database in terms of hemostatic efficacy not in clinical trial but in real clinical practice. Data on endoscopic hemostasis for non-variceal upper gastrointestinal bleeding (NVUGIB) were prospectively collected from February 2011 to December 2013. Among 1,584 patients with NVUGIB, 186 patients treated with hemoclip were enrolled in this study. Subjects were divided into three groups: Group 1 (n = 62), hemoclipping only; group 2 (n = 88), hemoclipping plus epinephrine injection; and group 3 (n = 36), hemocliping and epinephrine injection plus other endoscopic hemostatic modalities. Primary outcomes included rebleeding, other therapeutic management, hospitalization period, fasting period and mortality. Secondary outcomes were bleeding associated mortality and overall mortality. Active bleeding and peptic ulcer bleeding were more common in group 3 than in group 1 and in group 2 (p bleeding associated mortality and total mortality) were not different among groups. Combination therapy of epinephrine injection and other modalities with hemoclips did not show advantage over hemoclipping alone in this prospective cohort study. However, there is a tendency to perform combination therapy in active bleeding which resulted in equivalent hemostatic success rate, and this reflects the role of combination therapy in clinical practice.

  13. PROGNOSTIC SIGNIFICANCE OF CLINICAL, HISTOPATHOLOGICAL, AND MOLECULAR CHARACTERISTICS OF MEDULLOBLASTOMAS IN THE PROSPECTIVE HIT2000 MULTICENTER CLINICAL TRIAL COHORT

    Science.gov (United States)

    Pietsch, Torsten; Schmidt, Rene; Remke, Marc; Korshunov, Andrey; Hovestadt, Volker; Jones, David TW; Felsberg, Jörg; Kaulich, Kerstin; Goschzik, Tobias; Kool, Marcel; Northcott, Paul A.; von Hoff, Katja; von Bueren, André O.; Friedrich, Carsten; Skladny, Heyko; Fleischhack, Gudrun; Taylor, Michael D.; Cremer, Friedrich; Lichter, Peter; Faldum, Andreas; Reifenberger, Guido; Rutkowski, Stefan; Pfister, Stefan M.

    2014-01-01

    BACKGROUND: This study aimed to prospectively evaluate clinical, histopathological and molecular variables for outcome prediction in medulloblastoma patients. METHODS: Patients from the HIT2000 cooperative clinical trial were prospectively enrolled based on the availability of sufficient tumor material and complete clinical information. This revealed a cohort of 184 patients (median age 7.6 years), which was randomly split at a 2:1 ratio into a training (n = 127), and a validation (n = 57) dataset. All samples were subjected to thorough histopathological investigation, CTNNB1 mutation analysis, quantitative PCR, MLPA and FISH analyses for cytogenetic variables, and methylome analysis. RESULTS: By univariable analysis, clinical factors (M-stage), histopathological variables (large cell component, endothelial proliferation, synaptophysin pattern), and molecular features (chromosome 6q status, MYC amplification, TOP2A copy-number, subgrouping) were found to be prognostic. Molecular consensus subgrouping (WNT, SHH, Group 3, Group 4) was validated as an independent feature to stratify patients into different risk groups. When comparing methods for the identification of WNT-driven medulloblastoma, this study identified CTNNB1 sequencing and methylation profiling to most reliably identify these patients. After removing patients with particularly favorable (CTNNB1 mutation, extensive nodularity) or unfavorable (MYC amplification) markers, a risk score for the remaining “intermediate molecular risk” population dependent on age, M-stage, pattern of synaptophysin expression, and MYCN copy-number status was identified and validated, with speckled synaptophysin expression indicating worse outcome. CONCLUSIONS: Methylation subgrouping and CTNNB1 mutation status represent robust tools for the risk-stratification of medulloblastoma. A simple clinico-pathological risk score for “intermediate molecular risk” patients was identified, which deserves further validation

  14. Reflective action assessment with a prospective clinical problem solving tool in the context of rehabilitation medicine: an illustrative case study.

    Science.gov (United States)

    Kellett, David; Mpofu, Elias; Madden, Richard

    2013-06-01

    This study describes a case formulation approach applying a prospective ICF derived clinical tool to assess rehabilitation needs for a community dwelling stroke survivor with care from an outpatient rehabilitation medicine clinic. Case history data on the person were assessed for rehabilitation management planning using a prospective tool to interlink current with projected future functional status in everyday settings. Implicit assessment with reflective action informed decision points at each stage of the rehabilitation process. As a result of reflective action using the prospective tool, rehabilitation management led to significant changes in client participation after limitations to mobility and self care were mapped to the living conditions of the stroke survivor. The context sensitive rehabilitative plan resulted in higher subjective health-related quality of life in the stroke survivor and significant other and enhanced their capacity for participation. Reflective action informed assessment applying ICF concepts to clinical problem solving resulted in positive gains in health-related quality of life in a stroke survivor.

  15. Reproducing a Prospective Clinical Study as a Computational Retrospective Study in MIMIC-II.

    Science.gov (United States)

    Kury, Fabrício S P; Huser, Vojtech; Cimino, James J

    2015-01-01

    In this paper we sought to reproduce, as a computational retrospective study in an EHR database (MIMIC-II), a recent large prospective clinical study: the 2013 publication, by the Japanese Association for Acute Medicine (JAAM), about disseminated intravascular coagulation, in the journal Critical Care (PMID: 23787004). We designed in SQL and Java a set of electronic phenotypes that reproduced the study's data sampling, and used R to perform the same statistical inference procedures. All produced source code is available online at https://github.com/fabkury/paamia2015. Our program identified 2,257 eligible patients in MIMIC-II, and the results remarkably agreed with the prospective study. A minority of the needed data elements was not found in MIMIC-II, and statistically significant inferences were possible in the majority of the cases.

  16. DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

    Science.gov (United States)

    Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

    2015-01-01

    Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

  17. A national prospective study on childhood celiac disease in the Netherlands 1993-2000: an increasing recognition and a changing clinical picture

    NARCIS (Netherlands)

    Steens, R.F.; Csizmadia, C.G.; George, E.K.; Ninaber, M.K.; Hira Sing, R.A.; Mearin, M.L.

    2005-01-01

    OBJECTIVES: To investigate prospectively whether the incidence of diagnosed celiac disease (CD) is increasing in the Netherlands and whether the clinical presentation is changing. STUDY DESIGN: All newly diagnosed cases of CD throughout the Netherlands were registered prospectively from 1993 to

  18. A prospective cohort study of the clinical presentation of non-traumatic osteonecrosis of the femoral head: spine and knee symptoms as clinical presentation of hip osteonecrosis.

    Science.gov (United States)

    Hauzeur, Jean-Philippe; Malaise, Michel; de Maertelaer, Viviane

    2016-07-01

    To study the clinical presentation of femoral head osteonecrosis (ONFH). Publications dedicated to this aspect of ONFH are rare. Our aim was to systematically collect and describe the clinical data. A prospective survey was conducted in a cohort of ONFH recruited from a dedicated clinic for osteonecrosis. The history of symptoms, medical management, and physical findings were obtained from 88 patients suffering from 125 ONFH. Subgroups were formed: bilateral versus unilateral ONFH, radiological stages 1-2 (pre-fractured) versus fractured stage 3 versus stage 4. ONFH was bilateral in 63 %, especially in corticosteroid users and in sickle-cell cases. These patients were younger but had similar BMIs compared to the unilateral cases. The pain was mechanical in 79 % of hips and inflammatory in 21 %. Acute pain at the onset was present in 55 % of hips. The localization of this pain was variable, including in the groin, the buttocks, or diffused in the lower limbs. A limp was present in 50 % of the patients, only when one hip was painful. The physical examination of the hip was normal in 31 %, especially in stages 1-2 (55 %). The diagnosis delay was 12 months, with inadequate medical management in 51 % of patients. In ONFH cases, no typical clinical pattern was found. The clinical presentation was very variable, sometimes having spine or knee symptoms with a normal physical examination of the hip. ONFH should be systematically suspected in cases of onset of pain in the pelvis, buttocks, groin, and lower limbs.

  19. Clinical Features and Pattern of Presentation of Breast Diseases in ...

    African Journals Online (AJOL)

    Objective: To characterize the clinical features and pattern of presentation of breast diseases as observed in our practice. Materials and Methods: A prospective study of 121 consecutive patients with breast complaints presenting in our Surgical Outpatient Clinics. The relevant data were collected by two surgeons using the ...

  20. Pancreatic Cancer: Multicenter Prospective Data Collection and Analysis by the Hungarian Pancreatic Study Group.

    Science.gov (United States)

    Lakatos, Gábor; Balázs, Anita; Kui, Balázs; Gódi, Szilárd; Szücs, Ákos; Szentesi, Andrea; Szentkereszty, Zsolt; Szmola, Richárd; Kelemen, Dezső; Papp, Róbert; Vincze, Áron; Czimmer, József; Pár, Gabriella; Bajor, Judit; Szabó, Imre; Izbéki, Ferenc; Halász, Adrienn; Leindler, László; Farkas, Gyula; Takács, Tamás; Czakó, László; Szepes, Zoltán; Hegyi, Péter; Kahán, Zsuzsanna

    2016-06-01

    Pancreatic cancer is a devastating disease with poor prognosis. There is very limited information available regarding the epidemiology and treatment strategies of pancreatic cancer in Central Europe. The purpose of the study was to prospectively collect and analyze data of pancreatic cancer in the Hungarian population. The Hungarian Pancreatic Study Group (HPSG) organized prospective, uniform data collection. Altogether 354 patients were enrolled from 14 Hungarian centers. Chronic pancreatitis was present in 3.7% of the cases, while 33.7% of the patients had diabetes. Family history for pancreatic cancer was positive in 4.8%. The most frequent presenting symptoms included pain (63.8%), weight loss (63%) and jaundice (52.5%). The reported frequency of smoking and alcohol consumption was lower than expected (28.5% and 27.4%, respectively). The majority of patients (75.6%) were diagnosed with advanced disease. Most patients (83.6%) had a primary tumor located in the pancreatic head. The histological diagnosis was ductal adenocarcinoma in 90.7% of the cases, while neuroendocrine tumor was present in 5.3%. Biliary stent implantation was performed in 166 patients, 59.2% of them received metal stents. Primary tumor resection was performed in 60 (16.9%) patients. Enteral or biliary bypass was done in 35 and 49 patients, respectively. In a multivariate Cox-regression model, smoking status and presence of gemcitabine-based chemotherapy were identified as independent predictors for overall survival. We report the first data from a large cohort of Hungarian pancreatic cancer patients. We identified smoking status and chemotherapy as independent predictors in this cohort.

  1. Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study.

    Science.gov (United States)

    Mager, R; Kurosch, M; Höfner, T; Frees, S; Haferkamp, A; Neisius, A

    2018-01-22

    The purpose of this study is to analyze clinical outcomes and costs of single-use flexible ureterorenoscopes in comparison with reusable flexible ureterorenoscopes in a tertiary referral center. Prospectively, 68 flexible ureterorenoscopies utilizing reusable (Flex-X2S, Flex-X C , Karl Storz) and 68 applying single-use flexible ureterorenoscopes (LithoVue, Boston Scientific) were collected. Clinical outcome parameters such as overall success rate, complication rates according to Clavien-Dindo, operation time and radiation exposure time were measured. Cost analysis was based on purchase costs and recurrent costs for repair and reprocessing divided by number of procedures. In each group 68 procedures were available for evaluation. In 91% of reusable and 88% of single-use ureterorenoscopies stone disease was treated with a mean stone burden of 101 ± 226 and 90 ± 244 mm 2 and lower pole involvement in 47 and 41%, respectively (p > 0.05). Comparing clinical outcomes of reusable vs. single-use instruments revealed no significant difference for overall success rates (81 vs. 87%), stone-free rates (82 vs. 85%), operation time (76.2 ± 46.8 vs. 76.8 ± 40.2 min), radiation exposure time (3.83 ± 3.15 vs. 3.93 ± 4.43 min) and complication rates (7 vs. 17%) (p > 0.05). A wide range of repair and purchase costs resulted in total to $1212-$1743 per procedure for reusable ureterorenoscopy whereas price of single-use ureterorenoscopy was $1300-$3180 per procedure. The current work provided evidence for equal clinical effectiveness of reusable and single-use flexible ureterorenoscopes. Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions.

  2. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

    Science.gov (United States)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

    2016-03-22

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

  3. Design and Implementation of Data Collection Instruments for Neonatology Research

    Directory of Open Access Journals (Sweden)

    Monica G. HĂŞMĂŞANU

    2014-12-01

    Full Text Available im: The aim of our research was to design and implement data collection instruments to be use in context of an observational prospective clinical study with follow-up conducted on new born with intrauterine growth restriction. Methods: The structure of the data collection forms (paper based and electronic based was first identified and for each variable the best type to accomplish the research aim was established. The code for categorical variables has also been decided as well as the units of measurements for quantitative variables. In respect of good practice, a set of confounding factors (as gender, date of birth, etc. have also been identified and integrated in data collection instruments. Data-entry validation rules were implemented for each variable to reduce data input errors when the electronic data collection instrument was created. Results: Two data collection instruments have been developed and successfully implemented: a paper-based form and an electronic data collection instrument. The developed forms included demographics, neonatal complications (as hypoglycemia, hypocalcemia, etc., biochemical data at birth and follow-up, immunological data, as well as basal and follow-up echocardiographic data. Data-entry validation criteria have been implemented in electronic data collection instrument to assure validity and precision when paper-based data are translated in electronic form. Furthermore, to assure subject’s confidentiality a careful attention was given to HIPPA identifiers when electronic data collection instrument was developed. Conclusion: Data collection instruments were successfully developed and implemented as an a priori step in a clinical research for assisting data collection and management in a case of an observational prospective study with follow-up visits.

  4. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed trials.

    Directory of Open Access Journals (Sweden)

    Melissa Paoloni

    Full Text Available Molecularly-guided trials (i.e. PMed now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting.A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77% successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days. Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type.Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week. Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer into the preclinical

  5. Minimally Invasive Sacroiliac Joint Fusion Using a Novel Hydroxyapatite-Coated Screw: Preliminary 1-Year Clinical and Radiographic Results of a 2-Year Prospective Study.

    Science.gov (United States)

    Rappoport, Louis H; Luna, Ingrid Y; Joshua, Gita

    2017-05-01

    Proper diagnosis and treatment of sacroiliac joint (SIJ) pain remains a clinical challenge. Dysfunction of the SIJ can produce pain in the lower back, buttocks, and extremities. Triangular titanium implants for minimally invasive surgical arthrodesis have been available for several years, with reputed high levels of success and patient satisfaction. This study reports on a novel hydroxyapatite-coated screw for surgical treatment of SIJ pain. Data were prospectively collected on 32 consecutive patients who underwent minimally invasive SIJ fusion with a novel hydroxyapatite-coated screw. Clinical assessments and radiographs were collected and evaluated at 3, 6, and 12 months postoperatively. Mean (standard deviation) patient age was 55.2 ± 10.7 years, and 62.5% were female. More patients (53.1%) underwent left versus right SIJ treatment, mean operative time was 42.6 ± 20.4 minutes, and estimated blood loss did not exceed 50 mL. Overnight hospital stay was required for 84% of patients, and the remaining patients needed a 2-day stay (16%). Mean preoperative visual analog scale back and leg pain scores decreased significantly by 12 months postoperatively (P sacroiliac joint pain. Future clinical studies with larger samples are warranted to assess long-term patient outcomes. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II

    NARCIS (Netherlands)

    Versyck, B.; Geffen, G.J. van; Houwe, P. Van

    2017-01-01

    STUDY OBJECTIVE: The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. DESIGN: A prospective randomized double blind placebo-controlled study. SETTING:

  7. Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database

    International Nuclear Information System (INIS)

    Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M.; Lössl, Kristina

    2016-01-01

    To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future. The online version of this article (doi:10.1186/s13014-016-0624-8) contains supplementary material, which is available to authorized users

  8. [Clinical trials of laparoscopic gastric cancer surgery in South Korea: review and prospect].

    Science.gov (United States)

    Zhu, Chunchao; Zhao, Gang; Cao, Hui

    2018-02-25

    Laparoscopic technology is gradually accepted in gastric cancer surgery, whose efficacy has been demonstrated by some clinical researches. Randomized controlled trials (RCT) are considered as the most important evidence to prove clinical outcomes of laparoscopic surgery for gastric cancer. Korean gastric surgeons have made great contributions to RCT in laparoscopic gastric cancer surgery. KLASS (Korean Laparoscopic Gastrointestinal Surgery Study Group) is one of the most important forerunner and global leader of clinical trials of gastric cancer treatment. KLASS series clinical trials are attracting global attention because of the significant value of surgical treatment for gastric cancer. The RCTs in Korea involve in many aspects of laparoscopic gastrectomy for gastric cancer, including laparoscopy application in early gastric cancer (KLASS-01, KLASS-03 and KLASS-07), advanced gastric cancer (KLASS-02 and KLASS-06), function-preserving gastrectomy (KLASS-04,KLASS-05) and sentinel node navigation surgery (SENORITA trial). In order to share some informations of these RCTs, we review and prospect some important clinical trials of laparoscopic gastric cancer surgery in Korea. With the experience of Korean gastric surgeons, we can make more progress in our own clinical trials of laparoscopic gastric cancer surgery.

  9. Impact of positive and negative lesion site remodeling on clinical outcomes: insights from PROSPECT.

    Science.gov (United States)

    Inaba, Shinji; Mintz, Gary S; Farhat, Naim Z; Fajadet, Jean; Dudek, Dariusz; Marzocchi, Antonio; Templin, Barry; Weisz, Giora; Xu, Ke; de Bruyne, Bernard; Serruys, Patrick W; Stone, Gregg W; Maehara, Akiko

    2014-01-01

    This study investigated coronary artery remodeling patterns associated with clinical outcomes. In the prospective, multicenter PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree: An Imaging Study in Patients With Unstable Atherosclerotic Lesions) study, reported predictors of nonculprit lesion (NCL) major adverse cardiac events (MACE) were an intravascular ultrasound (IVUS) minimal lumen area (MLA) ≤4 mm(2), a plaque burden ≥70%, and a IVUS-virtual histology (VH) thin-cap fibroatheroma (TCFA), but not lesion site remodeling. Overall, 697 consecutive patients with an acute coronary syndrome were enrolled and underwent 3-vessel gray-scale and IVUS-VH; 3,223 NCLs were identified by IVUS. The remodeling index (RI) was calculated as the external elastic membrane area at the MLA site divided by the average of the proximal and distal reference external elastic membrane areas. First, one third of the patients were randomly selected to determine RI cutoffs related to NCL MACE (development cohort). Receiver-operating characteristic analysis showed that there were 2 separate cut points that predicted NCL MACE: RI = 0.8789 and RI = 1.0046 (area under the curve = 0.663). These cut points were used to define negative remodeling as an RI 1.00. Second, we used the remaining two-thirds of patients to validate these cut points with respect to lesion morphology and clinical outcomes (validation cohort). Kaplan-Meier curve analysis in the validation cohort showed that NCL MACE occurred more frequent (and equally) in negative and positive remodeling lesions compared with intermediate remodeling lesions. In this cohort, negative remodeling lesions had the smallest MLA, positive remodeling lesions had the largest plaque burden, and VH TCFA, especially VH TCFA with multiple necrotic cores, was most common in negatively remodeling lesions. The present study showed the novel concept that positive and negative lesion site remodeling was

  10. 75 FR 57470 - Clinical Center; Proposed Collection; Comment Request; Customer and Other Partners Satisfaction...

    Science.gov (United States)

    2010-09-21

    ... Collection; Comment Request; Customer and Other Partners Satisfaction Surveys SUMMARY: In compliance with the... Satisfaction Surveys. Type of Information Collection Request: Extension request. Need and Use of Information... evaluate the satisfaction of various Clinical Center customers and other partners with Clinical Center...

  11. Collective memory: a perspective from (experimental) clinical psychology.

    Science.gov (United States)

    Wessel, Ineke; Moulds, Michelle L

    2008-04-01

    This paper considers the concept of collective memory from an experimental clinical psychology perspective. Exploration of the term collective reveals a broad distinction between literatures that view collective memories as a property of groups (collectivistic memory) and those that regard these memories as a property of individuals who are, to a greater or lesser extent, an integral part of their social environment (social memory). First, we argue that the understanding of collectivistic memory phenomena may benefit from drawing parallels with current psychological models such as the self-memory system theory of individualistic autobiographical memory. Second, we suggest that the social memory literature may inform the study of trauma-related disorders. We argue that a factual focus induced by collaborative remembering may be beneficial to natural recovery in the immediate aftermath of trauma, and propose that shared remembering techniques may provide a useful addition to the treatment of post-traumatic stress disorder.

  12. Comparison of a trifocal intraocular lens with a+3.0 D bifocal IOL: results of a prospective randomized clinical trial

    NARCIS (Netherlands)

    Jonker, S.M.R.; Bauer, N.J.C.; Makhotkina, N.Y.; Berendschot, T.T.J.M.; van den Biggelaar, F.J.H.M.; Nuijts, R.M.M.A.

    Purpose To compare visual outcomes in patients with cataract surgery and bilateral implantation of a trifocal or bifocal intraocular lens (IOL). Setting University Eye Clinic Maastricht, the Netherlands. Design Prospective randomized clinical trial. Methods Eyes with cataract and less than 1.0

  13. Managing cancer pain and symptoms of outpatients by rotation to sustained-release hydromorphone: a prospective clinical trial

    NARCIS (Netherlands)

    Wirz, Stefan; Wartenberg, Hans Christian; Elsen, Christian; Wittmann, Maria; Diederichs, Marta; Nadstawek, Joachim

    2006-01-01

    PURPOSE: In this prospective clinical trial we examined the technique of opioid rotation to oral sustained-release hydromorphone for controlling pain and symptoms in outpatients with cancer pain. METHODS: Before and after rotation, 50 patients were assessed by Numerical Analog Scales [Numerical

  14. Longitudinal changes in the antecedent and early manifest course of bipolar disorder-A narrative review of prospective studies.

    Science.gov (United States)

    Pfennig, Andrea; Leopold, Karolina; Ritter, Philipp; Böhme, Anne; Severus, Emanuel; Bauer, Michael

    2017-05-01

    Prospective study designs ideally allow patients to be followed from the first manifestations of the illness or even from an at-risk stage. It can thus provide data on the predictive value of changes in clinical symptomatology, cognition or further biological markers to broaden our understanding of the etiopathology and symptomatic trajectory of bipolar disorders. The scope of this narrative review is to summarize evidence from prospectively collected data on psychopathological and other clinical and biological changes in the early developmental course of bipolar disorders. The narrative review was based on a literature search conducted in February 2016 within the PubMed library for prospective study data of persons in antecedent and early manifest stages of manifest bipolar disorder published within the last 15 years. A total of 19 prospective studies were included. Regarding psychopathological features; personality, temperament and character traits as well as changes in sleep and circadian rhythm, the evidence suggests that risk factors for the development of bipolar disorder can already be described and should be studied further to understand their interaction, mediation with other factors and timing in the developmental process of bipolar disorder. Apart from the positive family history, childhood anxiety, sleep problems, subthreshold (hypo)manic symptoms and certain character traits/emotionality should be identified and monitored already in clinical practice as their presence likely increases risk of bipolar disorder. Up to date no substantiated evidence was found from prospective studies addressing cognitive features, life events, immunological parameters and morphological central nervous system changes as potential risk factors for bipolar disorder. For an improved understanding of episodic disorders, longitudinal data collection is essential. Since the etiology of bipolar disorders is complex, a number of potential risk factors have been proposed

  15. Application of MALDI-TOF MS for requalification of a Candida clinical isolates culture collection

    Directory of Open Access Journals (Sweden)

    Reginaldo Lima-Neto

    2014-06-01

    Full Text Available Microbial culture collections underpin biotechnology applications and are important resources for clinical microbiology by supplying reference strains and/or performing microbial identifications as a service. Proteomic profiles by MALDI-TOF MS have been used for Candida spp. identification in clinical laboratories and demonstrated to be a fast and reliable technique for the routine identification of pathogenic yeasts. The main aim of this study was to apply MALDI-TOF MS combined with classical phenotypic and molecular approaches to identify Candida clinical isolates preserved from 1 up to 52 years in a Brazilian culture collection and assess its value for the identification of yeasts preserved in this type of collections. Forty Candida spp. clinical isolates were identified by morphological and biochemical analyses. Identifications were also performed by the new proteomic approach based on MALDI-TOF MS. Results demonstrated 15% discordance when compared with morphological and biochemical analyses. Discordant isolates were analysed by ITS sequencing, which confirmed the MALDI-TOF MS identifications and these strains were renamed in the culture collection catalogue. In conclusion, proteomic profiles by MALDI-TOF MS represents a rapid and reliable method for identifying clinical Candida species preserved in culture collections and may present clear benefits when compared with the performance of existing daily routine methods applied at health centres and hospitals.

  16. Prospective Clinical Testing of Regulatory Dendritic Cells in Organ Transplantation.

    Science.gov (United States)

    Thomson, Angus W; Zahorchak, Alan F; Ezzelarab, Mohamed B; Butterfield, Lisa H; Lakkis, Fadi G; Metes, Diana M

    2016-01-01

    Dendritic cells (DC) are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg) with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients' dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP)-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail.

  17. Posterior Circulation Ischemic Stroke—Clinical Characteristics, Risk Factors, and Subtypes in a North Indian Population: A Prospective Study

    OpenAIRE

    Mehndiratta, Manmohan; Pandey, Sanjay; Nayak, Rajeev; Alam, Anwar

    2012-01-01

    Background and Purpose: Posterior circulation stroke accounts for approximately 20% of all strokes with varied clinical presentation, which differ from strokes in anterior circulation, with reference to etiology, clinical features, and prognosis. Short penetrating and circumferential branches in the posterior circulation supply the brain stem, thalamus, cerebellum, occipital, and medial temporal lobes. Materials and Methods: We prospectively analyzed 80 participants of posterior circulation i...

  18. Serial diffusion-weighted MRI correlates with clinical course and treatment response in children with intracranial pus collections

    International Nuclear Information System (INIS)

    Fanning, Noel F.; Laffan, Eoghan E.; Shroff, Manohar M.

    2006-01-01

    Accurate assessment of treatment response in children with intracranial pus collections is vital to guide appropriate therapy and reduce morbidity and mortality. To correlate serial MR-measurable changes in diffusion-weighted imaging (DWI) with clinical response to treatment. We retrospectively reviewed clinical notes, conventional MR sequences and DWI in eight children with intracranial pus collections. Trace DWI signal intensity and apparent diffusion coefficient (ADC) values were compared at three time points: at initial diagnosis (eight children, 13 collections), at follow-up during continued clinical infection (three children, sp collections), and at follow-up when clinical infection had resolved (seven children, 12 collections). At initial diagnosis all patients were septic and collections showed restricted diffusion (mean ADC 0.61±0.15 x 10 -3 mm 2 /s). Patients with persistent clinical sepsis at follow-up DWI had collections with persistent low ADC values (0.66±0.21 x 10 -3 mm 2 /s), significantly (P -3 mm 2 /s, P<0.01) compared both to patients with signs of continued sepsis and to normal gray matter values. Persistent restricted diffusion in pus collections correlates with continued sepsis. Treatment response is associated with clinical resolution of sepsis and ADC value elevation significantly above normal gray matter values. (orig.)

  19. Prospective evaluation of a clinical guideline recommending hospital length of stay in upper gastrointestinal tract hemorrhage.

    Science.gov (United States)

    Hay, J A; Maldonado, L; Weingarten, S R; Ellrodt, A G

    Upper gastrointestinal tract hemorrhage (UGIH) is a common and potentially life-threatening disorder. Resource utilization can vary without adverse effect on patient outcome. Clinical practice guidelines are a potential solution to reduce variation in practice while improving patient outcomes. To validate prospectively the safety, acceptability, and impact of a clinical practice guideline defining the medically appropriate length of stay (LOS) for patients hospitalized with UGIH. Prospective, controlled time-series study with an alternate-month design. Outcome surveyors and patients were blinded to study group allocation. GUIDELINE: A retrospectively validated scoring system using 4 independent variables: hemodynamics, time from bleeding, comorbidity, and esophagogastroduodenoscopy (EGD) findings to predict risk of adverse events. The quantitative risk for the low-risk subset was 0.6% (95% confidence interval [CI], 0.0%-2.0%) for subsequent complications and 0% (95% CI, 0.0%-0.9%) for life-threatening complications from this retrospective evaluation. A 1000-bed, not-for-profit, university-affiliated teaching hospital. Consecutive adult patients hospitalized for acute UGIH. Concurrent feedback of guideline recommendation (same-day hospital discharge) to physicians caring for patients at low risk for complication. No risk information was provided during control months. Seventy percent (209/299) of UGIH patients achieved low-risk status according to the guideline and were therefore potentially suitable for early discharge from the hospital. Providing real-time quantitative risk information (intervention group only) was associated with an increase in guideline compliance from 30% to 70% (Preduction of 1.7 days per patient; P<.001). No differences in complications, patient health status, or patient satisfaction were found when measured 1 month after discharge. An independent variable predicting decreased hospital LOS for low-risk UGIH patients was early EGD

  20. Comparison of semen parameters in samples collected by masturbation at a clinic and at home.

    Science.gov (United States)

    Elzanaty, Saad; Malm, Johan

    2008-06-01

    To investigate differences in semen quality between samples collected by masturbation at a clinic and at home. Cross-sectional study. Fertility center. Three hundred seventy-nine men assessed for infertility. None. Semen was analyzed according to World Health Organization guidelines. Seminal markers of epididymal (neutral alpha-glucosidase), prostatic (prostate-specific antigen and zinc), and seminal vesicle (fructose) function were measured. Two patient groups were defined according to sample collection location: at a clinic (n = 273) or at home (n = 106). Compared with clinic-collected semen, home-collected samples had statistically significantly higher values for sperm concentration, total sperm count, rapid progressive motility, and total count of progressive motility. Semen volume, proportion of normal sperm morphology, neutral alpha-glucosidase, prostate-specific antigen, zinc, and fructose did not differ significantly between groups. An abnormal sperm concentration (masturbation at home compared with at a clinic. This should be taken into consideration in infertility investigations.

  1. A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

    Science.gov (United States)

    McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

    2001-05-01

    Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically

  2. Clinical Efficacy and Safety of Oral Qing-Dai in Patients with Ulcerative Colitis: A Single-Center Open-Label Prospective Study.

    Science.gov (United States)

    Sugimoto, Shinya; Naganuma, Makoto; Kiyohara, Hiroki; Arai, Mari; Ono, Keiko; Mori, Kiyoto; Saigusa, Keiichiro; Nanki, Kosaku; Takeshita, Kozue; Takeshita, Tatsuya; Mutaguchi, Makoto; Mizuno, Shinta; Bessho, Rieko; Nakazato, Yoshihiro; Hisamatsu, Tadakazu; Inoue, Nagamu; Ogata, Haruhiko; Iwao, Yasushi; Kanai, Takanori

    2016-01-01

    Chinese herbal medicine Qing-Dai (also known as indigo naturalis) has been used to treat various inflammatory conditions. However, not much has been studied about the use of oral Qing-Dai in the treatment for ulcerative colitis (UC) patients. Studies exploring alternative treatments for UC are of considerable interest. In this study, we aimed at prospectively evaluating the safety and efficacy of Qing-Dai for UC patients. The open-label, prospective pilot study was conducted at Keio University Hospital. A total of 20 patients with moderate UC activity were enrolled. Oral Qing-Dai in capsule form was taken twice a day (daily dose, 2 g) for 8 weeks. At week 8, the rates of clinical response, clinical remission, and mucosal healing were 72, 33, and 61%, respectively. The clinical and endoscopic scores, CRP levels, and fecal occult blood results were also significantly improved. We observed 2 patients with mild liver dysfunction; 1 patient discontinued due to infectious colitis and 1 patient discontinued due to mild nausea. This is the first prospective study indicating that oral Qing-Dai is effective for inducing remission in patients with moderate UC activity and can be tolerated. Thus, Qing-Dai may be considered an alternative treatment for patients, although further investigation is warranted. © 2016 S. Karger AG, Basel.

  3. Detection of Occult Micrometastases in Patients With Clinical Stage I Non-Small-Cell Lung Cancer: A Prospective Analysis of Mature Results of CALGB 9761 (Alliance).

    Science.gov (United States)

    Martin, Linda W; D'Cunha, Jonathan; Wang, Xiaofei; Herzan, Debra; Gu, Lin; Abraham, Naif; Demmy, Todd L; Detterbeck, Frank C; Groth, Shawn S; Harpole, David H; Krasna, Mark J; Kernstine, Kemp; Kohman, Leslie J; Patterson, G Alexander; Sugarbaker, David J; Vollmer, Robin T; Maddaus, Michael A; Kratzke, Robert A

    2016-05-01

    Outcomes after resection of stage I non-small-cell lung cancer (NSCLC) are variable, potentially due to undetected occult micrometastases (OM). Cancer and Leukemia Group B 9761 was a prospectively designed study aimed at determining the prognostic significance of OM. Between 1997 and 2002, 502 patients with suspected clinical stage I (T1-2N0M0) NSCLC were prospectively enrolled at 11 institutions. Primary tumor and lymph nodes (LNs) were collected and sent to a central site for molecular analysis. Both were assayed for OM using immunohistochemistry (IHC) for cytokeratin (AE1/AE3) and real-time reverse transcriptase polymerase chain reaction (RT-PCR) for carcinoembryonic antigen. Four hundred eighty-nine of the 502 enrolled patients underwent complete surgical staging. Three hundred four patients (61%) had pathologic stage I NSCLC (T1, 58%; T2, 42%) and were included in the final analysis. Fifty-six percent had adenocarcinomas, 34% had squamous cell carcinomas, and 10% had another histology. LNs from 298 patients were analyzed by IHC; 41 (14%) were IHC-positive (42% in N1 position, 58% in N2 position). Neither overall survival (OS) nor disease-free survival was associated with IHC positivity; however, patients who had IHC-positive N2 LNs had statistically significantly worse survival rates (hazard ratio, 2.04, P = .017). LNs from 256 patients were analyzed by RT-PCR; 176 (69%) were PCR-positive (52% in N1 position, 48% in N2 position). Neither OS nor disease-free survival was associated with PCR positivity. NSCLC tumor markers can be detected in histologically negative LNs by AE1/AE3 IHC and carcinoembryonic antigen RT-PCR. In this prospective, multi-institutional trial, the presence of OM by IHC staining in N2 LNs of patients with NSCLC correlated with decreased OS. The clinical significance of this warrants further investigation. © 2016 by American Society of Clinical Oncology.

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

    Science.gov (United States)

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

    2015-01-01

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

  5. Collective Construction of Knowledge in Clinical Biochemistry

    Directory of Open Access Journals (Sweden)

    S.B. Barreto

    2010-05-01

    Full Text Available The collective construction of knowledge occurs by the convergence of ideas and semantic. This paper was made for a graduation discipline, in 2009-2, with 240students who were separated into 4 groups: morning period (M1,M2 and night period (N1,N2. This study aims the collective construction of a abstract-manual of clinical biochemistry tests, due the difficulty in comprehension of certain concepts by the students; it intends to help them in the process of knowledge acquirement. The constructivist approach was adopted and the matters of the discipline were available in a “Student Group e-mail account”, a functional communication tool. The instructions were reachable on the web. M1,M2 and N1 made one part of the study at the first period. N2 did not conclude the study at the same time period of the other groups; therefore they received a new responsibility: they were supposed to conclude and correct the manual and its application which included 90 different kinds of labor exams. A textbook has been defined containing illustrative pictures of blood collection and biosecurity. Three banners were exposed inside the hall of the institution. Collective work is important for the effective arrangement in health area. In the process of teaching/learning, the teacher must proceed on practices and methodologies aiming the development of the student competences and skills which represent its professional identity.

  6. A prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes

    Directory of Open Access Journals (Sweden)

    Lipsky Benjamin A

    2012-09-01

    Full Text Available Abstract Background Complicated skin and soft tissue infections (cSSTIs occur frequently, but limited data do not allow any consensus on an optimal treatment strategy. We designed this prospective, multicenter, observational study to to explore the current epidemiology, treatment, and resulting clinical outcomes of cSSTIs to help develop strategies to potentially improve outcomes. Methods From June 2008 to December 2009 we enrolled a pre-specified number of adults treated in 56 U.S. hospitals with intravenous antibiotic(s for any of the following cSSTIs: diabetic foot infection (DFI; surgical site infection (SSI; deep soft tissue abscess (DSTA; or, cellulitis. Investigators treated all patients per their usual practice during the study and collected data on a standardized form. Results We enrolled 1,033 patients (DFI 27%; SSI 32%; DSTA 14%; cellulitis 27%; mean age 54 years; 54% male, of which 74% had healthcare-associated risk factors. At presentation, 89% of patients received initial empiric therapy with intravenous antibiotics; ~20% of these patients had this empiric regimen changed or discontinued based on culture and sensitivity results. Vancomycin was the most frequently used initial intravenous antibiotic, ordered in 61% of cases. During their stay 44% of patients underwent a surgical procedure related to the study infection, usually incision and drainage or debridement. The mean length of stay was 7.1 days, ranging from 5.8 (DSTA to 8.1 (SSI. Conclusion Our findings from this large prospective observational study that characterized patients with cSSTIs from diverse US inpatient populations provide useful information on the current epidemiology, clinical management practices and outcomes of this common infection.

  7. Persistent idiopathic facial pain - a prospective systematic study of clinical characteristics and neuroanatomical findings at 3.0 Tesla MRI.

    Science.gov (United States)

    Maarbjerg, Stine; Wolfram, Frauke; Heinskou, Tone Bruvik; Rochat, Per; Gozalov, Aydin; Brennum, Jannick; Olesen, Jes; Bendtsen, Lars

    2017-11-01

    Introduction Persistent idiopathic facial pain (PIFP) is a poorly understood chronic orofacial pain disorder and a differential diagnosis to trigeminal neuralgia. To address the lack of systematic studies in PIFP we here report clinical characteristics and neuroimaging findings in PIFP. Methods Data collection was prospective and standardized in consecutive PIFP patients. All patients underwent 3.0 MRI. Results In a cohort of 53 PIFP patients, the average age of onset was 44.1 years. PIFP was found in more women 40 (75%) than men 13 (25%), p < 0.001. There was a high prevalence of bilateral pain 7 (13%), hypoesthesia 23 (48%), depression 16 (30%) and other chronic pain conditions 17 (32%) and a low prevalence of stabbing pain 21 (40%), touch-evoked pain 14 (26%) and remission periods 10 (19%). The odds ratio between neurovascular contact and the painful side was 1.4 (95% Cl 0.4-4.4, p = 0.565) and the odds ratio between neurovascular contact with displacement of the trigeminal nerve and the painful side was 0.2 (95% Cl 0.0-2.1, p = 0.195). Conclusion PIFP is separated from trigeminal neuralgia both with respect to the clinical characteristics and neuroimaging findings, as NVC was not associated to PIFP.

  8. The clinical utility of informants' appraisals on prospective and retrospective memory in patients with early Alzheimer's disease.

    Directory of Open Access Journals (Sweden)

    Yen-Hsuan Hsu

    Full Text Available Increasing studies suggest the importance of including prospective memory measures in clinical evaluation of dementia due to its sensitivity and functional relevance. The Prospective and Retrospective Memory Questionnaire (PRQM is originally a self-rated memory inventory that offers a direct comparison between prospective and episodic memory. However, the informant's report has been recognized as a more valid source of cognitive complaints. We thus aimed to examine the validity of the informant-rated form of the PRMQ in assessing memory function of the patients and in detecting individuals with early dementia. The informants of 140 neurological outpatients with memory complaints completed the Taiwan version of the PRMQ. Tests of prospective memory, short-term memory, and general cognitive ability were also administered to non-demented participants and patients with early stages of Alzheimer's disease (AD. Results showed significant relationships between the PRMQ ratings and objective cognitive measures, and showed that higher ratings on the PRMQ were associated with increasing odds of greater dementia severity. Receiver operative characteristic (ROC curves showed an adequate ability of the PRMQ to identify patients with dementia (93% sensitivity and 84% specificity. Hierarchical regression revealed that the PRMQ has additional explanatory power for dementia status after controlling for age, education and objective memory test results, and that the prospective memory subscale owns predictive value for dementia beyond the retrospective memory subscale. The present study demonstrated the external validity and diagnostic value of informants' evaluation of their respective patients' prospective and retrospective memory functioning, and highlighted the important role of prospective memory in early dementia detection. The proxy-version of the PRMQ is a useful tool that captures prospective and episodic memory problems in patients with early AD, in

  9. Neuromuscular findings in thyroid dysfunction: a prospective clinical and electrodiagnostic study

    Science.gov (United States)

    Duyff, R.; Van den Bosch, J.; Laman, D; van Loon, B.-J. P.; Linssen, W.

    2000-01-01

    OBJECTIVES—To evaluate neuromuscular signs and symptoms in patients with newly diagnosed hypothyroidism and hyperthyroidism.
METHODS—A prospective cohort study was performed in adult patients with newly diagnosed thyroid dysfunction. Patients were evaluated clinically with hand held dynamometry and with electrodiagnosis. The clinical features of weakness and sensory signs and the biochemical data were evaluated during treatment.
RESULTS—In hypothyroid patients 79% had neuromuscular complaints, 38% had clinical weakness (manual muscle strength testing) in one or more muscle groups, 42% had signs of sensorimotor axonal neuropathy, and 29% had carpal tunnel syndrome. Serum creatine kinase did not correlate with weakness. After 1 year of treatment 13% of the patients still had weakness. In hyperthyroid patients 67% had neuromuscular symptoms, 62% had clinical weakness in at least one muscle group that correlated with FT4 concentrations, but not with serum CK. Nineteen per cent of the patients had sensory-motor axonal neuropathy and 0% had carpal tunnel syndrome. The neuromuscular signs developed rapidly, early in the course of the disorder and were severe, but resolved rapidly and completely during treatment (average time 3.6months).
CONCLUSIONS—Neuromuscular symptoms and signs were present in most patients. About 40% of the hypothyroid patients and 20% of the hyperthyroid patients had predominantly sensory signs of a sensorimotor axonal neuropathy early in the course of thyroid disease. Weakness in hyperthyroidism evolved rapidly at an early stage of the disorder and resolved completely during treatment, suggesting a functional muscle disorder. Hand held dynamometry is sensitive for the detection of weakness and for the clinical evaluation of treatment effects. Weakness in hypothyroidism is more difficult to treat, suggesting myopathy.

 PMID:10811699

  10. Prospective study of POLG mutations presenting in children with intractable epilepsy: Prevalence and clinical features

    OpenAIRE

    Uusimaa, Johanna; Gowda, Vasantha; McShane, Anthony; Smith, Conrad; Evans, Julie; Shrier, Annie; Narasimhan, Manisha; O'Rourke, Anthony; Rajabally, Yusuf; Hedderly, Tammy; Cowan, Frances; Fratter, Carl; Poulton, Joanna

    2013-01-01

    Purpose To assess the frequency and clinical features of childhood-onset intractable epilepsy caused by the most common mutations in the POLG gene, which encodes the catalytic subunit of mitochondrial DNA polymerase gamma. Methods Children presenting with nonsyndromic intractable epilepsy of unknown etiology but without documented liver dysfunction at presentation were eligible for this prospective, population-based study. Blood samples were analyzed for the three most common POLG mutations. ...

  11. Prospective assessment of clinical symptoms associated with enterovirus and parechovirus genotypes in a multicenter study in Dutch children

    NARCIS (Netherlands)

    de Crom, S. C. M.; Rossen, J. W. A.; de Moor, R. A.; Veldkamp, E. J. M.; van Furth, A. M.; Obihara, C. C.

    Background: Human non-polio enterovirus (EV) and human parechovirus (HPeV) are important pathogens viral infection and aseptic meningitis in children. The aim of this study is to prospectively compare the incidence, clinical signs, blood and cerebrospinal fluid in EV and HPeV infected children.

  12. A novel rapid access testicular cancer clinic: prospective evaluation after one year.

    Science.gov (United States)

    Carey, K; Davis, N F; Elamin, S; Ahern, P; Brady, C M; Sweeney, P

    2016-02-01

    Our institution has recently developed a rapid access outpatient clinic to investigate men with testicular lumps and/or pain suspicious for testicular cancer (TCa). To present our experience after 12 months. All referrals to the rapid access testicular clinic (RATC) clinic were prospectively analysed from 01/01/2013 to 01/01/2014. The primary outcome variable was incidence of TCa in the referred patient cohort. Secondary outcome variables were waiting times prior to clinical review and waiting times prior to radical orchidectomy in patients diagnosed with TCa. Seventy-four new patients were referred to the RATC during the 1-year period and the mean age was 34 (range 15-81 years). TCa was the most common diagnosis and was found in 18 (25 %) patients. Patients diagnosed with TCa underwent radical orchidectomy, a median of 3 (range 1-5) days after their initial GP referral. Patients requiring surgical intervention for benign scrotal pathology underwent their procedure a median of 32 (range 3-61) days after their initial referral. Of the 18 patients diagnosed with TCa, 9 (50 %) were diagnosed with a seminomatous germ cell tumour on histopathology. The RATC is a new initiative in Ireland that provides expedient and definitive treatment of patients with newly diagnosed TCa. Early treatment will ultimately improve long-term prognosis in this patient cohort.

  13. Systematic collection of patient reported outcome research data: A checklist for clinical research professionals.

    Science.gov (United States)

    Wehrlen, Leslie; Krumlauf, Mike; Ness, Elizabeth; Maloof, Damiana; Bevans, Margaret

    2016-05-01

    Understanding the human experience is no longer an outcome explored strictly by social and behavioral researchers. Increasingly, biomedical researchers are also including patient reported outcomes (PROs) in their clinical research studies not only due to calls for increased patient engagement in research but also healthcare. Collecting PROs in clinical research studies offers a lens into the patient's unique perspective providing important information to industry sponsors and the FDA. Approximately 30% of trials include PROs as primary or secondary endpoints and a quarter of FDA new drug, device and biologic applications include PRO data to support labeling claims. In this paper PRO, represents any information obtained directly from the patient or their proxy, without interpretation by another individual to ascertain their health, evaluate symptoms or conditions and extends the reference of PRO, as defined by the FDA, to include other sources such as patient diaries. Consumers and clinicians consistently report that PRO data are valued, and can aide when deciding between treatment options; therefore an integral part of clinical research. However, little guidance exists for clinical research professionals (CRPs) responsible for collecting PRO data on the best practices to ensure quality data collection so that an accurate assessment of the patient's view is collected. Therefore the purpose of this work was to develop and validate a checklist to guide quality collection of PRO data. The checklist synthesizes best practices from published literature and expert opinions addressing practical and methodological challenges CRPs often encounter when collecting PRO data in research settings. Published by Elsevier Inc.

  14. The effect of efavirenz versus nevirapine-containing regimens on immunologic, virologic and clinical outcomes in a prospective observational study

    NARCIS (Netherlands)

    Collaboration, H.-C.; Koopmans †, P.P.; Brouwer, A.M.; Dofferhoff, A.S.M.; Flier, M. van der; Groot, R. de; Hofstede, H.J.M. ter; Keuter, M.; Ven, A.J.A.M. van der; et al.,

    2012-01-01

    OBJECTIVE: To compare regimens consisting of either efavirenz or nevirapine and two or more nucleoside reverse transcriptase inhibitors (NRTIs) among HIV-infected, antiretroviral-naive, and AIDS-free individuals with respect to clinical, immunologic, and virologic outcomes. DESIGN: Prospective

  15. Long-term prospective cohort study on dental implants: clinical and microbiological parameters.

    Science.gov (United States)

    Tenenbaum, Henri; Bogen, Omer; Séverac, François; Elkaim, René; Davideau, Jean-Luc; Huck, Olivier

    2017-01-01

    The aim of the present prospective cohort study is to evaluate clinical and microbiological data of dental implants after at least 8 years of follow-up. A total of 110 patients and 232 implants were included at baseline and followed during 1 year. Fifty-two patients and 108 implants could be evaluated at the final examination. Clinical and microbiological data were taken at baseline, 1 year and at least 8 years. The mean follow-up time was 10.8 ± 1.7 years. Plaque index was, respectively, 0.50 ± 0.50 at baseline, 0.50 ± 0.50 at 1 year and 0.33 ± 0.67 at ≥8 years. Gingival index was, respectively, 1.08 ± 0.19 at baseline, 1.01 ± 0.39 at 1 year and 0.22 ± 0.47 at ≥8 years. Sulcular bleeding index was, respectively, 0.17 ± 0.22 at baseline, 0.11 ± 0.33 at 1 year and 0.17 ± 0.22 at ≥8 years. Probing depth was, respectively, 2.67 ± 0.75 at baseline, 3.00 ± 0.83 at 1 year and 2.74 ± 1.00 at ≥8 years. Clinical attachment level was, respectively, 3.75 ± 1.17 at baseline, 4.00 ± 1.06 at 1 year and 4.00 ± 1.17 at ≥8 years. Peri-implant mucositis was detected around 60.2% of implants in 73.1% of patients, while peri-implantitis was affecting 12% of implants in 15.4% of patients. Some bacteria species were associated with worsened clinical parameters. About 69.4% of implants (75/108) and 67.3% of the patients (35/52) were considered as success in the present prospective cohort study after a mean follow-up of 10.8 years. Microbial follow-up may help to identify patients at risk for peri-implant disease. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. Characterization of bacteriophages infecting clinical isolates of Pseudomonas aeruginosa stored in a culture collection

    Directory of Open Access Journals (Sweden)

    C.C.S. Zanetti

    2013-08-01

    Full Text Available Some clinical isolates of Pseudomonas aeruginosa stored in our culture collection did not grow or grew poorly and showed lysis on the culture plates when removed from the collection and inoculated on MacConkey agar. One hypothesis was that bacteriophages had infected and killed those clinical isolates. To check the best storage conditions to maintain viable P. aeruginosa for a longer time, clinical isolates were stored at various temperatures and were grown monthly. We investigated the presence of phage in 10 clinical isolates of P. aeruginosa stored in our culture collection. Four strains of P. aeruginosa were infected by phages that were characterized by electron microscopy and isolated to assess their ability to infect. The best condition to maintain the viability of the strains during storage was in water at room temperature. Three Siphoviridae and two Myoviridae phages were visualized and characterized by morphology. We confirmed the presence of bacteriophages infecting clinical isolates, and their ability to infect and lyse alternative hosts. Strain PAO1, however, did not show lysis to any phage. Mucoid and multidrug resistant strains of P. aeruginosa showed lysis to 50% of the phages tested.

  17. Clinical and echocardiographic assessment of the Medtronic Advantage aortic valve prosthesis: the Scandinavian multicentre, prospective study

    DEFF Research Database (Denmark)

    Haaverstad, Rune; Vitale, Nicola; Karevold, Asbjørn

    2006-01-01

    OBJECTIVE: The aim of this report is the prospective, multicentre evaluation of clinical results and haemodynamic performance of the Medtronic Advantage aortic valve prosthesis. METHODS: From April 2001 to June 2003, 166 patients (male:female 125:41; mean (SD) age 61.8 (11.8) years) received...... an aortic advantage valve prosthesis. Complete cumulative follow-up was 242.7 patient-years (maximum 3.2; mean 1.6 years). Postoperatively, patients underwent early (within 30 days) and 1 year transthoracic echocardiography. RESULTS: 30 day mortality was 2.4% (n = 4). Kaplan-Meier estimates of freedom from...... echocardiography. CONCLUSIONS: Haemodynamic performance and early clinical results of Medtronic advantage in the aortic position were satisfactory and comparable with those of other bileaflet valves in current clinical use....

  18. Social capital among healthcare professionals: A prospective study of its importance for job satisfaction, work engagement and engagement in clinical improvements.

    Science.gov (United States)

    Strömgren, Marcus; Eriksson, Andrea; Bergman, David; Dellve, Lotta

    2016-01-01

    Social capital can be an important resource to facilitate the needed improvements in quality of care and efficiency in hospitals. To assess the importance of social capital (recognition, vertical trust, horizontal trust and reciprocity) for job satisfaction, work engagement and engagement in clinical improvements. A prospective cohort design was used. Intensive care units and emergency, surgical and medical units at five Swedish hospitals with ongoing development of their processes of care. Healthcare professionals (physicians, registered nurses, assistant nurses) at five Swedish midsize hospitals. The participants answered a questionnaire at two occasions, NN=1602 at baseline and NN=1548 at one-year follow-up. Mean hospital response rate was 53% at baseline and 59% at follow-up. Univariate, multivariate and logistic regression analyses were performed, and the prospective analysis was based on 477 respondents. Social capital was associated with healthcare professionals' general work engagement and job satisfaction. Analysis showed positive associations between all measured aspects of social capital and engagement in clinical improvements of patient safety and quality of care. The prospective analysis showed that increased social capital predicted increased job satisfaction, work engagement and engagement in clinical improvements of patient safety. Social capital is strongly related to job satisfaction and active engagement with clinical improvements. The findings contribute to a deeper knowledge of social capital as a predictive factor that influences patient safety and health among healthcare staff. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. Prospective clinical testing of regulatory dendritic cells (DCreg in organ transplantation

    Directory of Open Access Journals (Sweden)

    ANGUS W THOMSON

    2016-01-01

    Full Text Available Dendritic cells (DC are rare, professional antigen-presenting cells with ability to induce or regulate alloimmune responses. Regulatory DC (DCreg with potential to down-modulate acute and chronic inflammatory conditions that occur in organ transplantation can be generated in vitro under a variety of conditions. Here, we provide a rationale for evaluation of DCreg therapy in clinical organ transplantation with the goal of promoting sustained, donor-specific hyporesponsiveness, while lowering the incidence and severity of rejection and reducing patients’ dependence on anti-rejection drugs. Generation of donor- or recipient-derived DCreg that suppress T cell responses and prolong transplant survival in rodents or non-human primates has been well-described. Recently, good manufacturing practice (GMP-grade DCreg have been produced at our Institution for prospective use in human organ transplantation. We briefly review experience of regulatory immune therapy in organ transplantation and describe our experience generating and characterizing human monocyte-derived DCreg. We propose a phase I/II safety study in which the influence of donor-derived DCreg combined with conventional immunosuppression on subclinical and clinical rejection and host alloimmune responses will be examined in detail.

  20. Association between neurovascular contact and clinical characteristics in classical trigeminal neuralgia

    DEFF Research Database (Denmark)

    Maarbjerg, Stine; Wolfram, Frauke; Gozalov, Aydin

    2015-01-01

    and severe NVC. METHODS: Clinical characteristics were prospectively collected from consecutive TN patients using semi-structured interviews in a cross-sectional study design. We evaluated 3.0 Tesla MRI blinded to the symptomatic side. RESULTS: We included 135 TN patients. Severe NVC was more prevalent...

  1. Novel Signs and Their Clinical Utility in Diagnosing Complex Regional Pain Syndrome (CRPS): A Prospective Observational Cohort Study.

    Science.gov (United States)

    Kuttikat, Anoop; Shaikh, Maliha; Oomatia, Amin; Parker, Richard; Shenker, Nicholas

    2017-06-01

    Delays in diagnosis occur with complex regional pain syndrome (CRPS). We define and prospectively demonstrate that novel bedside tests measuring body perception disruption can identify patients with CRPS postfracture. The objectives of our study were to define and validate 4 bedside tests, to identify the prevalence of positive tests in patients with CRPS and other chronic pain conditions, and to assess the clinical utility (sensitivity, specificity, positive predictive value, negative predictive value) for identifying CRPS within a Fracture cohort. This was a single UK teaching hospital prospective cohort study with 313 recruits from pain-free volunteers and patients with chronic pain conditions.Four novel tests were Finger Perception (FP), Hand Laterality identification (HL), Astereognosis (AS), and Body Scheme (BS) report. Five questionnaires (Brief Pain Inventory, Upper Extremity Functional Index, Lower Extremity Functional Index, Neglect-like Symptom Questionnaire, Hospital Anxiety and Depression Score) assessed the multidimensional pain experience. FP and BS were the best performing tests. Prospective monitoring of fracture patients showed that out of 7 fracture patients (total n=47) who had both finger misperception and abnormal BS report at initial testing, 3 developed persistent pain with 1 having a formal diagnosis of CRPS. Novel signs are reliable, easy to perform, and present in chronic pain patients. FP and BS have significant clinical utility in predicting persistent pain in a fracture group thereby allowing targeted early intervention.

  2. A Prospective Study on the Clinical and Microbiological Spectrum of Endophthalmitis in a Specific Region in Denmark

    DEFF Research Database (Denmark)

    Solborg Bjerrum, Søren; Hamoudi, Hassan; Friis-Møller, Alice

    2016-01-01

    PURPOSE: To study the clinical and microbiological spectrum of endophthalmitis with emphasis on clinical features, visual outcomes and risks of surgical complications. METHODS: A prospective observational study was conducted between 2012 and 2013 in a specific region in Denmark. Patients were...... clinically examined before, during and after surgical intervention for endophthalmitis. RESULTS: Fifty eyes with endophthalmitis were included. Endophthalmitis after cataract surgery (post-cataract), anti-VEGF (vascular endothelial growth factor) intravitreal injections (post-injection) and cases...... of endogenous endophthalmitis were responsible for 40, 28 and 18% of all cases, respectively. There was no difference in the microbiological spectrum in post-cataract patients and post-injection patients, but patients with post-cataract endophthalmitis presented statistically significantly more frequently...

  3. Biomarkers in differentiating clinical dengue cases: A prospective cohort study

    Directory of Open Access Journals (Sweden)

    Gary Kim Kuan Low

    2015-12-01

    Full Text Available Objective: To evaluate five biomarkers (neopterin, vascular endothelial growth factor-A, thrombomodulin, soluble vascular cell adhesion molecule 1 and pentraxin 3 in differentiating clinical dengue cases. Methods: A prospective cohort study was conducted whereby the blood samples were obtained at day of presentation and the final diagnosis were obtained at the end of patients’ follow-up. All patients included in the study were 15 years old or older, not pregnant, not infected by dengue previously and did not have cancer, autoimmune or haematological disorder. Median test was performed to compare the biomarker levels. A subgroup Mann-Whitney U test was analysed between severe dengue and non-severe dengue cases. Monte Carlo method was used to estimate the 2-tailed probability (P value for independent variables with unequal number of patients. Results: All biomarkers except thrombomodulin has P value < 0.001 in differentiating among the healthy subjects, non-dengue fever, dengue without warning signs and dengue with warning signs/severe dengue. Subgroup analysis for all the biomarkers between severe dengue and non-severe dengue cases was not statistically significant except vascular endothelial growth factor-A (P < 0.05. Conclusions: Certain biomarkers were able to differentiate the clinical dengue cases. This could be potentially useful in classifying and determining the severity of dengue infected patients in the hospital.

  4. 77 FR 41431 - Proposed Collection; Comment Request: Impact of Clinical Research Training and Medical Education...

    Science.gov (United States)

    2012-07-13

    ... Request: Impact of Clinical Research Training and Medical Education at the Clinical Center on Physician Careers in Academia and Clinical Research SUMMARY: In compliance with the requirement of Section 3506(c)(2... approval. Proposed Collection Title: The Impact of Clinical Research Training and Medical Education at the...

  5. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma

    Directory of Open Access Journals (Sweden)

    Hamid Omid

    2011-11-01

    Full Text Available Abstract Background Ipilimumab, a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4, has demonstrated an improvement in overall survival in two phase III trials of patients with advanced melanoma. The primary objective of the current trial was to prospectively explore candidate biomarkers from the tumor microenvironment for associations with clinical response to ipilimumab. Methods In this randomized, double-blind, phase II biomarker study (ClinicalTrials.gov NCT00261365, 82 pretreated or treatment-naïve patients with unresectable stage III/IV melanoma were induced with 3 or 10 mg/kg ipilimumab every 3 weeks for 4 doses; at Week 24, patients could receive maintenance doses every 12 weeks. Efficacy was evaluated per modified World Health Organization response criteria and safety was assessed continuously. Candidate biomarkers were evaluated in tumor biopsies collected pretreatment and 24 to 72 hours after the second ipilimumab dose. Polymorphisms in immune-related genes were also evaluated. Results Objective response rate, response patterns, and safety were consistent with previous trials of ipilimumab in melanoma. No associations between genetic polymorphisms and clinical activity were observed. Immunohistochemistry and histology on tumor biopsies revealed significant associations between clinical activity and high baseline expression of FoxP3 (p = 0.014 and indoleamine 2,3-dioxygenase (p = 0.012, and between clinical activity and increase in tumor-infiltrating lymphocytes (TILs between baseline and 3 weeks after start of treatment (p = 0.005. Microarray analysis of mRNA from tumor samples taken pretreatment and post-treatment demonstrated significant increases in expression of several immune-related genes, and decreases in expression of genes implicated in cancer and melanoma. Conclusions Baseline expression of immune-related tumor biomarkers and a post-treatment increase in TILs may be positively associated with

  6. On the improvement of blood sample collection at clinical laboratories.

    Science.gov (United States)

    Grasas, Alex; Ramalhinho, Helena; Pessoa, Luciana S; Resende, Mauricio G C; Caballé, Imma; Barba, Nuria

    2014-01-09

    Blood samples are usually collected daily from different collection points, such hospitals and health centers, and transported to a core laboratory for testing. This paper presents a project to improve the collection routes of two of the largest clinical laboratories in Spain. These routes must be designed in a cost-efficient manner while satisfying two important constraints: (i) two-hour time windows between collection and delivery, and (ii) vehicle capacity. A heuristic method based on a genetic algorithm has been designed to solve the problem of blood sample collection. The user enters the following information for each collection point: postal address, average collecting time, and average demand (in thermal containers). After implementing the algorithm using C programming, this is run and, in few seconds, it obtains optimal (or near-optimal) collection routes that specify the collection sequence for each vehicle. Different scenarios using various types of vehicles have been considered. Unless new collection points are added or problem parameters are changed substantially, routes need to be designed only once. The two laboratories in this study previously planned routes manually for 43 and 74 collection points, respectively. These routes were covered by an external carrier company. With the implementation of this algorithm, the number of routes could be reduced from ten to seven in one laboratory and from twelve to nine in the other, which represents significant annual savings in transportation costs. The algorithm presented can be easily implemented in other laboratories that face this type of problem, and it is particularly interesting and useful as the number of collection points increases. The method designs blood collection routes with reduced costs that meet the time and capacity constraints of the problem.

  7. Prospective, randomized evaluation of a personal digital assistant-based research tool in the emergency department

    Directory of Open Access Journals (Sweden)

    Dinizio Anthony

    2008-01-01

    Full Text Available Abstract Background Personal digital assistants (PDA offer putative advantages over paper for collecting research data. However, there are no data prospectively comparing PDA and paper in the emergency department. The aim of this study was to prospectively compare the performance of PDA and paper enrollment instruments with respect to time required and errors generated. Methods We randomized consecutive patients enrolled in an ongoing prospective study to having their data recorded either on a PDA or a paper data collection instrument. For each method, we recorded the total time required for enrollment, and the time required for manual transcription (paper onto a computer database. We compared data error rates by examining missing data, nonsensical data, and errors made during the transcription of paper forms. Statistical comparisons were performed by Kruskal-Wallis and Poisson regression analyses for time and errors, respectively. Results We enrolled 68 patients (37 PDA, 31 paper. Two of 31 paper forms were not available for analysis. Total data gathering times, inclusive of transcription, were significantly less for PDA (6:13 min per patient compared to paper (9:12 min per patient; p Conclusion Using a PDA-based data collection instrument for clinical research reduces the time required for data gathering and significantly improves data integrity.

  8. Arthrocentesis and Temporomandibular Joint Disorders: Clinical and Radiological Results of a Prospective Study

    Directory of Open Access Journals (Sweden)

    Giacomo De Riu

    2013-01-01

    Full Text Available Purpose. We evaluated the efficacy of arthrocentesis in the treatment of temporomandibular joint (TMJ disorders. Material and Methods. In this prospective clinical case series, 30 consecutive patients with TMJ disorders underwent arthrocentesis using saline and sodium hyaluronate injections. Outcome measures were TMJ pain, maximum mouth opening (MMO, joint noises, and anatomical changes in the TMJ architecture. Patients were evaluated using cone-beam computed tomography (CBCT and magnetic resonance imaging (MRI at the beginning of treatment and 60 days after the last arthrocentesis. Pretreatment and posttreatment clinical parameters were compared using paired and unpaired t-tests, and McNemar’s test was used to evaluate CBCT and MRI changes (. Results. At 1-year follow-up examinations, visual analogue scale scores indicated that pain was reduced significantly and mean postoperative MMO was increased significantly. CBCT findings showed no significant change, and MRI showed only slight reductions in inflammatory signs. Conclusions. Within the limitations of this study, we can conclude that arthrocentesis is a simple, minimally invasive procedure with a relatively low risk of complications and significant clinical benefits in patients with TMJ disorders. This trial is registered with NCT01903512.

  9. Rationale and design of the BUDAPEST-CRT Upgrade Study: a prospective, randomized, multicentre clinical trial.

    Science.gov (United States)

    Merkely, Bela; Kosztin, Annamaria; Roka, Attila; Geller, Laszlo; Zima, Endre; Kovacs, Attila; Boros, Andras Mihaly; Klein, Helmut; Wranicz, Jerzy K; Hindricks, Gerhard; Clemens, Marcell; Duray, Gabor Z; Moss, Arthur J; Goldenberg, Ilan; Kutyifa, Valentina

    2017-09-01

    There is lack of conclusive evidence from randomized clinical trials on the efficacy and safety of upgrade to cardiac resynchronization therapy (CRT) in patients with implanted pacemakers (PM) or defibrillators (ICD) with reduced left ventricular ejection fraction (LVEF) and chronic heart failure (HF). The BUDAPEST-CRT Upgrade Study was designed to compare the efficacy and safety of CRT upgrade from conventional PM or ICD therapy in patients with intermittent or permanent right ventricular (RV) septal/apical pacing, reduced LVEF, and symptomatic HF. The BUDAPEST-CRT study is a prospective, randomized, multicentre, investigator-sponsored clinical trial. A total of 360 subjects will be enrolled with LVEF ≤ 35%, NYHA functional classes II-IVa, paced QRS ≥ 150 ms, and a RV pacing ≥ 20%. Patients will be followed for 12 months. Randomization is performed in a 3:2 ratio (CRT-D vs. ICD). The primary composite endpoint is all-cause mortality, a first HF event, or less than 15% reduction in left ventricular (LV) end-systolic volume at 12 months. Secondary endpoints are all-cause mortality, all-cause mortality or HF event, and LV volume reduction at 12 months. Tertiary endpoints include changes in quality of life, NYHA functional class, 6 min walk test, natriuretic peptides, and safety outcomes. The results of our prospective, randomized, multicentre clinical trial will provide important information on the role of cardiac resynchronization therapy with defibrillator (CRT-D) upgrade in patients with symptomatic HF, reduced LVEF, and wide-paced QRS with intermittent or permanent RV pacing. NCT02270840. © The Author 2016. Published by Oxford University Press on behalf of the European Society of Cardiology.

  10. 06. Facilitating Collection of Research and Quality Data in Integrative Medicine Clinical Settings: Views From Academic, Health System and Private Clinics

    Science.gov (United States)

    Dolor, Rowena; Victorson, David; Amoils, Steve

    2013-01-01

    Focus Areas: Integrative Approaches to Care The purpose of this panel discussion is to share successful efforts from a practice-based research network (PBRN) including ten integrative medicine clinics. The BraveNet PBRN includes integrative medicine clinics with academic health centers, large health systems, and a stand-alone private practice clinic. While clinical care is prioritized across all of these centers, introducing research into clinical sites oriented to providing care poses challenges that vary by clinic environment. We will highlight some of the unique issues encountered when trying to standardize data collection in sites practicing a patient-centered, whole-systems approach to healing as well as the solutions used to overcome these issues. We will present some operational solutions and data collected from the PBRN's ongoing data registry, entitled PRIMIER. The panel will engage attendees in a dialogue centering on potential for future analyses of existing results, ideas for possible upcoming studies, and creative ways to expand the PBRN data registry to include additional sites that may have expertise and interest in participating.

  11. Clinical trial enrollment, patient characteristics, and survival differences in prospectively registered metastatic colorectal cancer patients

    DEFF Research Database (Denmark)

    Sorbye, Halfdan; Pfeiffer, Per; Cavalli-Björkman, Nina

    2009-01-01

    BACKGROUND: Trial accrual patterns were examined to determine whether metastatic colorectal cancer (mCRC) patients enrolled in trials are representative of a general cancer population concerning patient characteristics and survival. METHODS: A total of 760 mCRC patients referred for their first...... oncological consideration at 3 hospitals in Scandinavia covering defined populations were registered consecutively during 2003 to 2006. Clinical trial enrollment, patient characteristics, and treatment were recorded prospectively, and the follow-up was complete. RESULTS: Palliative chemotherapy was initiated...

  12. The Clinical Research Center for Depression Study: Baseline Characteristics of a Korean Long-Term Hospital-Based Observational Collaborative Prospective Cohort Study

    Science.gov (United States)

    Kim, Tae-Suk; Jeong, Seung Hee; Kim, Jung-Bum; Lee, Min-Soo; Kim, Jae-Min; Yim, Hyeon-Woo

    2011-01-01

    Objective The Clinical Research Center for Depression (CRESCEND) study is a 9-year observational collaborative prospective cohort study for the clinical outcomes in participants with depressive disorders in Korea. In this study, we examined the baseline characteristics of the depressive participants as the hospital-based cohort. Methods Participants were assessed using various instruments including the Clinical Global Impression scale, 17-item Hamilton Depression Rating Scale (HDRS-17), Hamilton Anxiety Rating Scale, Brief Psychiatric Rating Scale, Social and Occupational Functioning Assessment Scale, Beck Depression Inventory-Second Edition, Scale for Suicide Ideation, and World Health Organization Quality of Life assessment instruments-abbreviated version. Also, personal histories of medical and psychiatric illnesses and the range of socio-epidemiologic and clinical data were collected from each participant. Results One thousand one hundred eighty three participants were recruited from 18 hospitals. The mean age of the participants was 47.9±15.9 year-old, 74.4% were female, 82.9% had been diagnosed of major depressive disorder, 40.9% were experiencing their first depressive episode, and 21.4% had a past history of suicide attempts. The majority (85.3%) of the participants were moderately to severely ill. The average HDRS-17 was 19.8±6.1. Significant gender differences at baseline were shown in age, education, marriage, employment, religion, and first depressive episode. Conclusion The baseline findings in the CRESCEND study showed some different characteristics of depression in Korea, suggesting a possibility of ethnic and cultural factors in depression. PMID:21519530

  13. Discrepancies Between Clinical Diagnoses and Autopsy Findings in Critically Ill Children: A Prospective Study.

    Science.gov (United States)

    Carlotti, Ana P C P; Bachette, Letícia G; Carmona, Fabio; Manso, Paulo H; Vicente, Walter V A; Ramalho, Fernando S

    2016-12-01

    To evaluate the discrepancies between clinical and autopsy diagnoses in patients who died in the pediatric intensive care units (PICUs) of a tertiary care university hospital. A prospective study of all consecutive autopsies discussed at monthly mortality conferences over 5 years. Discrepancies between premortem and autopsy diagnoses were classified according to modified Goldman et al criteria. From January 1, 2011, to December 31, 2015, a total of 2,679 children were admitted to the two PICUs of our hospital; 257 (9.6%) died, 150 (58.4%) underwent autopsy, and 123 were included. Complete concordance between clinical and postmortem diagnoses was observed in 86 (69.9%) patients; 20 (16.3%) had a class I discrepancy, and eight (6.5%) had a class II discrepancy. Comparing 2011 and 2015, the rate of major discrepancies decreased from 31.6% to 15%. Our results emphasize the importance of autopsy to clarify the cause of death and its potential contribution to improvement of team performance and quality of care. © American Society for Clinical Pathology, 2016. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  14. Longevity of metal-ceramic crowns cemented with self-adhesive resin cement: a prospective clinical study

    Science.gov (United States)

    Brondani, Lucas Pradebon; Pereira-Cenci, Tatiana; Wandsher, Vinicius Felipe; Pereira, Gabriel Kalil; Valandro, Luis Felipe; Bergoli, César Dalmolin

    2017-04-10

    Resin cements are often used for single crown cementation due to their physical properties. Self-adhesive resin cements gained widespread due to their simplified technique compared to regular resin cement. However, there is lacking clinical evidence about the long-term behavior of this material. The aim of this prospective clinical trial was to assess the survival rates of metal-ceramic crowns cemented with self-adhesive resin cement up to six years. One hundred and twenty-nine subjects received 152 metal-ceramic crowns. The cementation procedures were standardized and performed by previously trained operators. The crowns were assessed as to primary outcome (debonding) and FDI criteria. Statistical analysis was performed using Kaplan-Meier statistics and descriptive analysis. Three failures occurred (debonding), resulting in a 97.6% survival rate. FDI criteria assessment resulted in scores 1 and 2 (acceptable clinical evaluation) for all surviving crowns. The use of self-adhesive resin cement is a feasible alternative for metal-ceramic crowns cementation, achieving high and adequate survival rates.

  15. Mild cognitive impairment and prospective memory: translating the evidence into neuropsychological practice.

    Science.gov (United States)

    Kinsella, Glynda J; Pike, Kerryn E; Cavuoto, Marina G; Lee, Stephen D

    2018-04-30

    There has been a recent rapid development of research characterizing prospective memory performance in mild cognitive impairment (MCI) in older age. However, this body of literature remains largely separated from routine clinical practice in neuropsychology. Furthermore, there is emerging evidence of effective interventions to improve prospective memory performance. Therefore, our objective in this article was to offer a clinical neuropsychological perspective on the existing research in order to facilitate the translation of the evidence-base into clinical practice. By conducting a critical review of the existing research related to prospective memory and MCI, we highlight how this data can be introduced into clinical practice, either within diagnostic assessment or clinical management. Prospective memory is impaired in older adults with MCI, with a pattern of performance that helps with differential diagnosis from healthy aging. Clinical neuropsychologists are encouraged to add prospective memory assessment to their toolbox for diagnostic evaluation of clients with MCI. Preliminary findings of prospective memory interventions in MCI are promising, but more work is required to determine how different approaches translate to increasing independence in everyday life.

  16. The Danish Multiple Sclerosis Registry. History, data collection and validity

    DEFF Research Database (Denmark)

    Koch-Henriksen, N; Rasmussen, S; Stenager, E

    2001-01-01

    The Danish Multiple Sclerosis Registry was formally established in 1956 but started operating in 1949 with a nationwide prevalence survey. Since then, the Registry has continued collecting data on new and old cases of multiple sclerosis (MS) or suspected MS from multiple sources. The Registry...... instrument for monitoring incidence and prevalence, analysing survival, performing genetic analysis, providing unselected patient samples for clinical analyses, performing case-control studies and prospective studies and estimating the need for treatment and care....

  17. A Prospective Clinical Trial Combining Radiation Therapy With Systemic Immunotherapy in Metastatic Melanoma

    Energy Technology Data Exchange (ETDEWEB)

    Hiniker, Susan M., E-mail: shiniker@stanford.edu [Department of Radiation Oncology, Stanford University Medical Center and Cancer Institute, Stanford, California (United States); Reddy, Sunil A. [Division of Oncology, Department of Medicine, Stanford University Medical Center and Cancer Institute, Stanford, California (United States); Maecker, Holden T.; Subrahmanyam, Priyanka B.; Rosenberg-Hasson, Yael [Human Immune Monitoring Center, Institute for Immunity, Transplantation, and Infection, Stanford University Medical Center, Stanford, California (United States); Swetter, Susan M. [Department of Dermatology, Pigmented Lesion and Melanoma Program, Stanford University Medical Center and Cancer Institute, Stanford, California (United States); Dermatology Service, Veterans Affairs Palo Alto Health Care System, Palo Alto, California (United States); Saha, Saurabh [Atlas Venture, Cambridge, Massachusetts (United States); Shura, Lei; Knox, Susan J. [Department of Radiation Oncology, Stanford University Medical Center and Cancer Institute, Stanford, California (United States)

    2016-11-01

    Purpose: Local radiation therapy (RT) combined with systemic anti-cytotoxic T-lymphocyte–associated protein-4 immunotherapy may enhance induction of systemic antimelanoma immune responses. The primary objective of the present trial was to assess the safety and efficacy of combining ipilimumab with RT in patients with stage IV melanoma. The secondary objectives included laboratory assessment of induction of antimelanoma immune responses. Methods and Materials: In our prospective clinical trial, 22 patients with stage IV melanoma were treated with palliative RT and ipilimumab for 4 cycles. RT to 1 to 2 disease sites was initiated within 5 days after starting ipilimumab. Patients had ≥1 nonirradiated metastasis measuring ≥1.5 cm available for response assessment. Tumor imaging studies were obtained at baseline, 2 to 4 weeks after cycle 4 of ipilimumab, and every 3 months until progression. Laboratory immune response parameters were measured before and during treatment. Results: Combination therapy was well-tolerated without unexpected toxicities. Eleven patients (50.0%) experienced clinical benefit from therapy, including complete and partial responses and stable disease at median follow-up of 55 weeks. Three patients (27.3%) achieved an ongoing systemic complete response at a median follow-up of 55 weeks (range 32-65), and 3 (27.3%) had an initial partial response for a median of 40 weeks. Analysis of immune response data suggested a relationship between elevated CD8-activated T-cells and response. Conclusion: This is the second prospective clinical trial of treatment of metastatic melanoma using the combination of RT and systemic immunotherapy and the first using this sequence of therapy. The results from the present trial demonstrate that a subset of patients may benefit from combination therapy, arguing for continued clinical investigation of the use of RT combined with immunotherapy, including programmed cell death 1 inhibitors, which might have the

  18. A Prospective Clinical Trial Combining Radiation Therapy With Systemic Immunotherapy in Metastatic Melanoma

    International Nuclear Information System (INIS)

    Hiniker, Susan M.; Reddy, Sunil A.; Maecker, Holden T.; Subrahmanyam, Priyanka B.; Rosenberg-Hasson, Yael; Swetter, Susan M.; Saha, Saurabh; Shura, Lei; Knox, Susan J.

    2016-01-01

    Purpose: Local radiation therapy (RT) combined with systemic anti-cytotoxic T-lymphocyte–associated protein-4 immunotherapy may enhance induction of systemic antimelanoma immune responses. The primary objective of the present trial was to assess the safety and efficacy of combining ipilimumab with RT in patients with stage IV melanoma. The secondary objectives included laboratory assessment of induction of antimelanoma immune responses. Methods and Materials: In our prospective clinical trial, 22 patients with stage IV melanoma were treated with palliative RT and ipilimumab for 4 cycles. RT to 1 to 2 disease sites was initiated within 5 days after starting ipilimumab. Patients had ≥1 nonirradiated metastasis measuring ≥1.5 cm available for response assessment. Tumor imaging studies were obtained at baseline, 2 to 4 weeks after cycle 4 of ipilimumab, and every 3 months until progression. Laboratory immune response parameters were measured before and during treatment. Results: Combination therapy was well-tolerated without unexpected toxicities. Eleven patients (50.0%) experienced clinical benefit from therapy, including complete and partial responses and stable disease at median follow-up of 55 weeks. Three patients (27.3%) achieved an ongoing systemic complete response at a median follow-up of 55 weeks (range 32-65), and 3 (27.3%) had an initial partial response for a median of 40 weeks. Analysis of immune response data suggested a relationship between elevated CD8-activated T-cells and response. Conclusion: This is the second prospective clinical trial of treatment of metastatic melanoma using the combination of RT and systemic immunotherapy and the first using this sequence of therapy. The results from the present trial demonstrate that a subset of patients may benefit from combination therapy, arguing for continued clinical investigation of the use of RT combined with immunotherapy, including programmed cell death 1 inhibitors, which might have the

  19. Postoperative intraspinal subdural collections after pediatric posterior fossa tumor resection: incidence, imaging, and clinical features.

    Science.gov (United States)

    Harreld, J H; Mohammed, N; Goldsberry, G; Li, X; Li, Y; Boop, F; Patay, Z

    2015-05-01

    Postoperative intraspinal subdural collections in children after posterior fossa tumor resection may temporarily hinder metastasis detection by MR imaging or CSF analysis, potentially impacting therapy. We investigated the incidence, imaging and clinical features, predisposing factors, and time course of these collections after posterior fossa tumor resection. Retrospective review of postoperative spine MRI in 243 children (5.5 ± 4.6 years of age) from our clinical data base postresection of posterior fossa tumors from October 1994 to August 2010 yielded 37 (6.0 ± 4.8 years of age) subjects positive for postoperative intraspinal subdural collections. Their extent and signal properties were recorded for postoperative (37/37), preoperative (15/37), and follow-up spine (35/37) MRI. Risk factors were compared with age-matched internal controls (n = 37, 5.9 ± 4.5 years of age). Associations of histology, hydrocephalus and cerebellar tonsillar herniation, and postoperative intracranial subdural collections with postoperative intraspinal subdural collections were assessed by the Fisher exact test or χ(2) test. The association between preoperative tumor volume and postoperative intraspinal subdural collections was assessed by the Wilcoxon rank sum test. The overall incidence of postoperative intraspinal subdural collections was 37/243 (15.2%), greatest ≤7 days postoperatively (36%); 97% were seen 0-41 days postoperatively (12.9 ± 11.0 days). They were T2 hyperintense and isointense to CSF on T1WI, homogeneously enhanced, and resolved on follow-up MR imaging (35/35). None were symptomatic. They were associated with intracranial subdural collections (P = .0011) and preoperative tonsillar herniation (P = .0228). Postoperative intraspinal subdural collections are infrequent and clinically silent, resolve spontaneously, and have a distinctive appearance. Preoperative tonsillar herniation appears to be a predisposing factor. In this series, repeat MR imaging by 4 weeks

  20. Acinetobacter baumannii-Infected Vascular Catheters Collected from Horses in an Equine Clinic

    OpenAIRE

    Vaneechoutte, Mario; Devriese, Luc A.; Dijkshoorn, Lenie; Lamote, Benedicte; Deprez, Piet; Verschraegen, Gerda; Haesebrouck, Freddy

    2000-01-01

    Acinetobacter baumannii was isolated from tips clipped from seven intravenous jugular catheters collected from horses in the Ghent University equine clinic. They originated from seven different horses. Three of the seven showed evidence of local infection.

  1. A prospective cohort study of treatment decision-making for prostate cancer following participation in a multidisciplinary clinic.

    Science.gov (United States)

    Hurwitz, Lauren M; Cullen, Jennifer; Elsamanoudi, Sally; Kim, Daniel J; Hudak, Jane; Colston, Maryellen; Travis, Judith; Kuo, Huai-Ching; Porter, Christopher R; Rosner, Inger L

    2016-05-01

    Patients diagnosed with prostate cancer (PCa) are presented with several treatment options of similar efficacy but varying side effects. Understanding how and why patients make their treatment decisions, as well as the effect of treatment choice on long-term outcomes, is critical to ensuring effective, patient-centered care. This study examined treatment decision-making in a racially diverse, equal-access, contemporary cohort of patients with PCa counseled on treatment options at a multidisciplinary clinic. A prospective cohort study was initiated at the Walter Reed National Military Medical Center (formerly Walter Reed Army Medical Center) in 2006. Newly diagnosed patients with PCa were enrolled before attending a multidisciplinary clinic. Patients completed surveys preclinic and postclinic to assess treatment preferences, reasons for treatment choice, and decisional regret. As of January 2014, 925 patients with PCa enrolled in this study. Surgery (54%), external radiation (20%), and active surveillance (12%) were the most common primary treatments for patients with low- and intermediate-risk PCa, whereas patients with high-risk PCa chose surgery (34%) or external radiation with neoadjuvant hormones (57%). Treatment choice differed by age at diagnosis, race, comorbidity status, and calendar year in both univariable and multivariable analyses. Patients preferred to play an active role in the decision-making process and cited doctors at the clinic as the most helpful source of treatment-related information. Almost all patients reported satisfaction with their decision. This is one of the first prospective cohort studies to examine treatment decision-making in an equal-access, multidisciplinary clinic setting. Studies of this cohort would aid in understanding and improving the PCa decision-making process. Published by Elsevier Inc.

  2. Rationalisation in public dental care – impact on clinical work tasks and mechanical exposure for dentists – a prospective study

    DEFF Research Database (Denmark)

    Jonker, D.; Rolander, B.; Balogh, I.

    2013-01-01

    . In the present prospective study we assessed mechanical exposures among Swedish dentists in relation to specific rationalisations of clinical dental work during a six-year period. Body postures and movements of 12 dentists were assessed by inclinometry synchronised to video recordings of their work...

  3. Acceptability and feasibility of repeated mucosal specimen collection in clinical trial participants in Kenya.

    Directory of Open Access Journals (Sweden)

    Gloria Omosa-Manyonyi

    Full Text Available Mucosal specimens are essential to evaluate compartmentalized immune responses to HIV vaccine candidates and other mucosally targeted investigational products. We studied the acceptability and feasibility of repeated mucosal sampling in East African clinical trial participants at low risk of HIV and other sexually transmitted infections.The Kenya AIDS Vaccine Initiative (KAVI enrolled participants into three Phase 1 trials of preventive HIV candidate vaccines in 2011-2012 at two clinical research centers in Nairobi. After informed consent to a mucosal sub-study, participants were asked to undergo collection of mucosal secretions (saliva, oral fluids, semen, cervico-vaginal and rectal, but could opt out of any collection at any visit. Specimens were collected at baseline and two additional time points. A tolerability questionnaire was administered at the final sub-study visit. Of 105 trial participants, 27 of 34 women (79% and 62 of 71 men (87% enrolled in the mucosal sub-study. Nearly all sub-study participants gave saliva and oral fluids at all visits. Semen was collected from about half the participating men (47-48% at all visits. Cervico-vaginal secretions were collected by Softcup from about two thirds of women (63% at baseline, increasing to 78% at the following visits, with similar numbers for cervical secretion collection by Merocel sponge; about half of women (52% gave cervico-vaginal samples at all visits. Rectal secretions were collected with Merocel sponge from about a quarter of both men and women (24% at all 3 visits, with 16% of men and 19% of women giving rectal samples at all visits.Repeated mucosal sampling in clinical trial participants in Kenya is feasible, with a good proportion of participants consenting to most sampling methods with the exception of rectal samples. Experienced staff members of both sexes and trained counselors with standardized messaging may improve acceptance of rectal sampling.

  4. Detection of Occult Micrometastases in Patients With Clinical Stage I Non–Small-Cell Lung Cancer: A Prospective Analysis of Mature Results of CALGB 9761 (Alliance)

    Science.gov (United States)

    D’Cunha, Jonathan; Wang, Xiaofei; Herzan, Debra; Gu, Lin; Abraham, Naif; Demmy, Todd L.; Detterbeck, Frank C.; Groth, Shawn S.; Harpole, David H.; Krasna, Mark J.; Kernstine, Kemp; Kohman, Leslie J.; Patterson, G. Alexander; Sugarbaker, David J.; Vollmer, Robin T.; Maddaus, Michael A.; Kratzke, Robert A.

    2016-01-01

    Purpose Outcomes after resection of stage I non–small-cell lung cancer (NSCLC) are variable, potentially due to undetected occult micrometastases (OM). Cancer and Leukemia Group B 9761 was a prospectively designed study aimed at determining the prognostic significance of OM. Materials and Methods Between 1997 and 2002, 502 patients with suspected clinical stage I (T1-2N0M0) NSCLC were prospectively enrolled at 11 institutions. Primary tumor and lymph nodes (LNs) were collected and sent to a central site for molecular analysis. Both were assayed for OM using immunohistochemistry (IHC) for cytokeratin (AE1/AE3) and real-time reverse transcriptase polymerase chain reaction (RT-PCR) for carcinoembryonic antigen. Results Four hundred eighty-nine of the 502 enrolled patients underwent complete surgical staging. Three hundred four patients (61%) had pathologic stage I NSCLC (T1, 58%; T2, 42%) and were included in the final analysis. Fifty-six percent had adenocarcinomas, 34% had squamous cell carcinomas, and 10% had another histology. LNs from 298 patients were analyzed by IHC; 41 (14%) were IHC-positive (42% in N1 position, 58% in N2 position). Neither overall survival (OS) nor disease-free survival was associated with IHC positivity; however, patients who had IHC-positive N2 LNs had statistically significantly worse survival rates (hazard ratio, 2.04, P = .017). LNs from 256 patients were analyzed by RT-PCR; 176 (69%) were PCR-positive (52% in N1 position, 48% in N2 position). Neither OS nor disease-free survival was associated with PCR positivity. Conclusion NSCLC tumor markers can be detected in histologically negative LNs by AE1/AE3 IHC and carcinoembryonic antigen RT-PCR. In this prospective, multi-institutional trial, the presence of OM by IHC staining in N2 LNs of patients with NSCLC correlated with decreased OS. The clinical significance of this warrants further investigation. PMID:26926677

  5. The relevance of clinical and radiographic features of jaw lesions: A prospective study

    Directory of Open Access Journals (Sweden)

    Juliane Piragine ARAUJO

    Full Text Available Abstract The study was carried out in a Brazilian population and the aim was to describe the prevalence and the clinic-radiographical features of jaw lesions. In addition, a comparison between the main diagnosis hypothesis and final diagnosis was accessed. A prospective study which evaluated all patients with jaw lesions diagnosed in an Oral Diagnosis Center, between August 2013 and October 2014. A total of 450 patients were observed for the first time, and 130 had some type of jaw lesion. The mean age of the patients was 35.2 years ± 17.86. Among these, 71 were women (54.62% and 87 were Caucasian (66.92%. The mandible was affected more frequently (71.43% than the maxilla (28.57%. Swelling and pain were the most frequent clinical signs and symptoms and were observed in 60 (42.85% and 38 (27.14% cases, respectively. The panoramic x-ray was the main radiographic exam utilized (88.57%. Radiolucent lesions accounted for 89 cases (63.57% and the unilocular form was present in 114 cases (81.43%. A total of 93 cases had histopathological analyses and the periapical cyst was the most frequent lesion. In the other 47 lesions, the diagnosis was conducted by clinical and radiographic management. Bone lesions were frequent, being noted on first visit in approximately 30% of patients; in 1/3 of the cases, the diagnoses were completed with a combination of clinical and radiographic exams.

  6. Risk of deep venous thrombosis in elective neurosurgical procedures: a prospective, Doppler ultrasound-based study in children 12 years of age or younger.

    Science.gov (United States)

    Scherer, Andrea G; White, Ian K; Shaikh, Kashif A; Smith, Jodi L; Ackerman, Laurie L; Fulkerson, Daniel H

    2017-07-01

    OBJECTIVE The risk of venous thromboembolism (VTE) from deep venous thrombosis (DVT) is significant in neurosurgical patients. VTE is considered a leading cause of preventable hospital deaths and preventing DVT is a closely monitored quality metric, often tied to accreditation, hospital ratings, and reimbursement. Adult protocols include prophylaxis with anticoagulant medications. Children's hospitals may adopt adult protocols, although the incidence of DVT and the risk or efficacy of treatment is not well defined. The incidence of DVT in children is likely less than in adults, although there is very little prospectively collected information. Most consider the risk of DVT to be extremely low in children 12 years of age or younger. However, this consideration is based on tradition and retrospective reviews of trauma databases. In this study, the authors prospectively evaluated pediatric patients undergoing a variety of elective neurosurgical procedures and performed Doppler ultrasound studies before and after surgery. METHODS A total of 100 patients were prospectively enrolled in this study. All of the patients were between the ages of 1 month and 12 years and were undergoing elective neurosurgical procedures. The 91 patients who completed the protocol received a bilateral lower-extremity Doppler ultrasound examination within 48 hours prior to surgery. Patients did not receive either medical or mechanical DVT prophylaxis during or after surgery. The ultrasound examination was repeated within 72 hours after surgery. An independent, board-certified radiologist evaluated all sonograms. We prospectively collected data, including potential risk factors, details of surgery, and details of the clinical course. All patients were followed clinically for at least 1 year. RESULTS There was no clinical or ultrasound evidence of DVT or VTE in any of the 91 patients. There was no clinical evidence of VTE in the 9 patients who did not complete the protocol. CONCLUSIONS In this

  7. Etiology of genital ulcer disease. A prospective study of 278 cases seen in an STD clinic in Paris.

    Science.gov (United States)

    Hope-Rapp, Emilie; Anyfantakis, Vassili; Fouéré, Sebastien; Bonhomme, Philippe; Louison, Jean B; de Marsac, Thibault Tandeau; Chaine, Benedicte; Vallee, Pascale; Casin, Isabelle; Scieux, Catherine; Lassau, François; Janier, Michel

    2010-03-01

    The goal of this study was to identify the causes and factors associated with genital ulcer disease (GUD) among patients attending a sexually transmitted disease (STD) clinic in Paris. This study was a prospective investigation of GUD cases. Data were collected from 1995 to 2005. In each case, a Dark Field Examination (DFE), Gram stain, inoculation onto Thayer Martin agar, Columbia agar and chocolate agar with 1% isovitalex and 20% fetal calf serum, PCR Chlamydia trachomatis (Amplicor Roche), culture for herpes simplex virus (HSV) on MRC 5 cells and PCR HSV (Argene Biosoft) were obtained from the ulceration. First Catch Urine (FCU) PCR for Chlamydia trachomatis and syphilis, HIV, HSV, and HBV serologies were also performed. A total 278 cases of GUD were investigated, 244 (88%) in men and 34 (12%) in women. Primary syphilis accounted for 98 cases (35%), genital herpes for 74 (27%), chancroid for 8 (3%), other infections for 12 (5%). In 91 (32%) patients, no identifiable microorganism was documented. Primary syphilis was more prevalent in MSMs (P chancroid were significantly associated with heterosexuality (both P 10 mm (OR: 9.2 [95% CI: 2.9-30.7], P chancroid and reemergence of infectious syphilis have led to a new distribution of pathogens, genital herpes, primary syphilis and GUD from unknown origin, accounting each for one third of cases. No clinical characteristic is predictive of the etiology, underlining the importance of performing a thorough microbiologic evaluation. Close association with HIV is still a major public health problem.

  8. Are Collapsed Cervical Discs Amenable to Total Disc Arthroplasty?: Analysis of Prospective Clinical Data With 2-Year Follow Up.

    Science.gov (United States)

    Patwardhan, Avinash G; Carandang, Gerard; Voronov, Leonard I; Havey, Robert M; Paul, Gary A; Lauryssen, Carl; Coric, Domagoj; Dimmig, Thomas; Musante, David

    2016-12-15

    Analysis of prospectively collected radiographic data. To investigate the influence of preoperative index-level range of motion (ROM) and disc height on postoperative ROM after cervical total disc arthroplasty (TDA) using compressible disc prostheses. Clinical studies demonstrate benefits of motion preservation over fusion; however, questions remain unanswered as to which preoperative factors have the ability to identify patients who are most likely to have good postoperative motion, which is the primary rationale for TDA. We analyzed prospectively collected data from a single-arm, multicenter study with 2-year follow up of 30 patients with 48 implanted levels. All received compressible cervical disc prostheses of 6 mm-height (M6C, Spinal Kinetics, Sunnyvale, CA). The influence of index-level preoperative disc height and ROM (each with two levels: below-median and above-median) on postoperative ROM was analyzed using 2 x 2 ANOVA. We further analyzed the radiographic outcomes of a subset of discs with preoperative height less than 3 mm, the so-called "collapsed" discs. Shorter (3.0 ± 0.4 mm) discs were significantly less mobile preoperatively than taller (4.4 ± 0.5 mm) discs (6.7° vs. 10.5°, P = 0.01). The postoperative ROM did not differ between the shorter and taller discs (5.6° vs. 5.0°, P = 0.63). Tall discs that were less mobile preoperatively had significantly smaller postoperative ROM than short discs with above-median preoperative mobility (P < 0.05). The "collapsed discs" (n = 8) were less mobile preoperatively compared with all discs combined (5.1° vs. 8.6°, P < 0.01). These discs were distracted to more than two times the preoperative height, from 2.6 to 5.7 mm, and had significantly greater postoperative ROM than all discs combined (7.6° vs. 5.3°, P < 0.05). We observed a significant interaction between preoperative index-level disc height and ROM in influencing postoperative ROM. Although limited by small sample

  9. Patient-centered and clinical outcomes of mandibular overdentures retained with the locator system: A prospective observational study.

    Science.gov (United States)

    Fernandez-Estevan, Lucia; Montero, Javier; Selva Otaolaurruchi, Eduardo J; Sola Ruiz, Fernanda

    2017-03-01

    Whether clinical or demographic variables affect the perception of treatment in terms of quality of life and satisfaction is unknown. The purpose of this prospective study was to make an evidence-based assessment of the treatment outcomes (patient- and clinically based) of locator-retained mandibular overdentures. This prospective observational study assessed patients with edentulism who had worn mandibular overdentures supported by 2 implants and retained by the locator system for at least 1 year of functional life (N=80). Medical histories were reviewed, and patients underwent oral examinations. Prosthetic clinical outcomes and patient well-being were registered using the Oral Health Impact Profile 20 (OHIP-20) and Oral Satisfaction Scale (OSS). Patient well-being scored an overall OHIP-20 score of 19.0 ±14.0 of 80 (the higher the score, the greater the impact and the worse the oral health-related quality of life); overall oral satisfaction was 8.3 ±1.7 of 10. Women suffered greater social impact (0.8 ±1.0) and disability (0.4 ±0.8) than men (0.4 ±0.7 versus 0.2 ±0.4, respectively). Impact on well-being was inversely proportional to both patient age and the age of the prosthesis (r=-0.25; Poverdentures had been functioning for over 60 months. Relining (46.3%), readjustments (82.5%), and changes of nylon retention (1.5 ±1.8 per patient over 60 months of use) devices negatively influenced well-being. Mandibular overdentures produced good results with regard to quality of life and oral satisfaction, but attention should be paid to factors affecting clinical outcomes and patient well-being. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  10. Prospective clinical study of prosthetic treatment outcome of implantretained-removable-partial-denture during 5 year-follow-ups

    OpenAIRE

    Mehran Bahrami; Mohammed Hussein Mahmood Alsharbaty

    2017-01-01

    Background IRRPD offers patients the ability to upgrade their treatment planning to implant-supported-overdentures (ISOs) or implant-supported-fixed-prostheses (ISFPs) through insertion of more implants in the future after the loss of the remaining natural teeth. Aims The purpose of this prospective-clinical-study was to evaluate the success rate and treatment outcome of IRRPD for 15 patients, during at least 5-year-follow-ups after prosthetic rehabilitation with respect to implant ...

  11. Longevity of metal-ceramic crowns cemented with self-adhesive resin cement: a prospective clinical study

    Directory of Open Access Journals (Sweden)

    Lucas Pradebon BRONDANI

    2017-04-01

    Full Text Available Abstract Resin cements are often used for single crown cementation due to their physical properties. Self-adhesive resin cements gained widespread due to their simplified technique compared to regular resin cement. However, there is lacking clinical evidence about the long-term behavior of this material. The aim of this prospective clinical trial was to assess the survival rates of metal-ceramic crowns cemented with self-adhesive resin cement up to six years. One hundred and twenty-nine subjects received 152 metal-ceramic crowns. The cementation procedures were standardized and performed by previously trained operators. The crowns were assessed as to primary outcome (debonding and FDI criteria. Statistical analysis was performed using Kaplan-Meier statistics and descriptive analysis. Three failures occurred (debonding, resulting in a 97.6% survival rate. FDI criteria assessment resulted in scores 1 and 2 (acceptable clinical evaluation for all surviving crowns. The use of self-adhesive resin cement is a feasible alternative for metal-ceramic crowns cementation, achieving high and adequate survival rates.

  12. Security Approaches in Using Tablet Computers for Primary Data Collection in Clinical Research

    OpenAIRE

    Wilcox, Adam B.; Gallagher, Kathleen; Bakken, Suzanne

    2013-01-01

    Next-generation tablets (iPads and Android tablets) may potentially improve the collection and management of clinical research data. The widespread adoption of tablets, coupled with decreased software and hardware costs, has led to increased consideration of tablets for primary research data collection. When using tablets for the Washington Heights/Inwood Infrastructure for Comparative Effectiveness Research (WICER) project, we found that the devices give rise to inherent security issues asso...

  13. Recommendations for Collection and Handling of Specimens From Group Breast Cancer Clinical Trials

    Science.gov (United States)

    Leyland-Jones, Brian R.; Ambrosone, Christine B.; Bartlett, John; Ellis, Matthew J.C.; Enos, Rebecca A.; Raji, Adekunle; Pins, Michael R.; Zujewski, Jo Anne; Hewitt, Stephen M.; Forbes, John F.; Abramovitz, Mark; Braga, Sofia; Cardoso, Fatima; Harbeck, Nadia; Denkert, Carsten; Jewell, Scott D.

    2008-01-01

    Recommendations for specimen collection and handling have been developed for adoption across breast cancer clinical trials conducted by the Breast International Group (BIG)-sponsored Groups and the National Cancer Institute (NCI)-sponsored North American Cooperative Groups. These recommendations are meant to promote identifiable standards for specimen collection and handling within and across breast cancer trials, such that the variability in collection/handling practices that currently exists is minimized and specimen condition and quality are enhanced, thereby maximizing results from specimen-based diagnostic testing and research. Three working groups were formed from the Cooperative Group Banking Committee, BIG groups, and North American breast cancer cooperative groups to identify standards for collection and handling of (1) formalin-fixed, paraffin-embedded (FFPE) tissue; (2) blood and its components; and (3) fresh/frozen tissue from breast cancer trials. The working groups collected standard operating procedures from multiple group specimen banks, administered a survey on banking practices to those banks, and engaged in a series of discussions from 2005 to 2007. Their contributions were synthesized into this document, which focuses primarily on collection and handling of specimens to the point of shipment to the central bank, although also offers some guidance to central banks. Major recommendations include submission of an FFPE block, whole blood, and serial serum or plasma from breast cancer clinical trials, and use of one fixative and buffer type (10% neutral phosphate-buffered formalin, pH 7) for FFPE tissue across trials. Recommendations for proper handling and shipping were developed for blood, serum, plasma, FFPE, and fresh/frozen tissue. PMID:18955459

  14. Clinical applicability and cost of a 46-gene panel for genomic analysis of solid tumours: Retrospective validation and prospective audit in the UK National Health Service.

    Directory of Open Access Journals (Sweden)

    Angela Hamblin

    2017-02-01

    Full Text Available Single gene tests to predict whether cancers respond to specific targeted therapies are performed increasingly often. Advances in sequencing technology, collectively referred to as next generation sequencing (NGS, mean the entire cancer genome or parts of it can now be sequenced at speed with increased depth and sensitivity. However, translation of NGS into routine cancer care has been slow. Healthcare stakeholders are unclear about the clinical utility of NGS and are concerned it could be an expensive addition to cancer diagnostics, rather than an affordable alternative to single gene testing.We validated a 46-gene hotspot cancer panel assay allowing multiple gene testing from small diagnostic biopsies. From 1 January 2013 to 31 December 2013, solid tumour samples (including non-small-cell lung carcinoma [NSCLC], colorectal carcinoma, and melanoma were sequenced in the context of the UK National Health Service from 351 consecutively submitted prospective cases for which treating clinicians thought the patient had potential to benefit from more extensive genetic analysis. Following histological assessment, tumour-rich regions of formalin-fixed paraffin-embedded (FFPE sections underwent macrodissection, DNA extraction, NGS, and analysis using a pipeline centred on Torrent Suite software. With a median turnaround time of seven working days, an integrated clinical report was produced indicating the variants detected, including those with potential diagnostic, prognostic, therapeutic, or clinical trial entry implications. Accompanying phenotypic data were collected, and a detailed cost analysis of the panel compared with single gene testing was undertaken to assess affordability for routine patient care. Panel sequencing was successful for 97% (342/351 of tumour samples in the prospective cohort and showed 100% concordance with known mutations (detected using cobas assays. At least one mutation was identified in 87% (296/342 of tumours. A locally

  15. Developing a stone database for clinical practice.

    Science.gov (United States)

    Turney, Benjamin W; Noble, Jeremy G; Reynard, John M

    2011-09-01

    Our objective was to design an intranet-based database to streamline stone patient management and data collection. The system developers used a rapid development approach that removed the need for laborious and unnecessary documentation, instead focusing on producing a rapid prototype that could then be altered iteratively. By using open source development software and website best practice, the development cost was kept very low in comparison with traditional clinical applications. Information about each patient episode can be entered via a user-friendly interface. The bespoke electronic stone database removes the need for handwritten notes, dictation, and typing. From the database, files may be automatically generated for clinic letters, operation notes. and letters to family doctors. These may be printed or e-mailed from the database. Data may be easily exported for audits, coding, and research. Data collection remains central to medical practice, to improve patient safety, to analyze medical and surgical outcomes, and to evaluate emerging treatments. Establishing prospective data collection is crucial to this process. In the current era, we have the opportunity to embrace available technology to facilitate this process. The database template could be modified for use in other clinics. The database that we have designed helps to provide a modern and efficient clinical stone service.

  16. Impact of scribes on patient interaction, productivity, and revenue in a cardiology clinic: a prospective study

    Directory of Open Access Journals (Sweden)

    Kenney WO

    2013-08-01

    Full Text Available Alan J Bank,1 Christopher Obetz,2 Ann Konrardy,2 Akbar Khan,1 Kamalesh M Pillai,1 Benjamin J McKinley,1 Ryan M Gage,1 Mark A Turnbull,1 William O Kenney1 1United Heart and Vascular Clinic, St Paul, MN, USA; 2Abbott Northwestern Hospital, Minneapolis, MN, USA Objective: Scribes have been used in the emergency department to improve physician productivity and patient interaction. There are no controlled, prospective studies of scribe use in the clinic setting. Methods: A prospective controlled study compared standard visits (20 minute follow-up and 40 minute new patient to a scribe system (15 minute follow-up and 30 minute new patient in a cardiology clinic. Physician productivity, patient satisfaction, physician–patient interaction, and revenue were measured. Results: Four physicians saw 129 patients using standard care and 210 patients with scribes during 65 clinic hours each. Patients seen per hour increased (P < 0.001 from 2.2 ± 0.3 to 3.5 ± 0.4 (59% increase and work relative value units (wRVU per hour increased (P < 0.001 from 3.5 ± 1.3 to 5.5 ± 1.3 (57% increase. Patient satisfaction was high at baseline and unchanged with scribes. In a substudy, direct patient contact time was lower (9.1 ± 2.0 versus 12.9 ± 3.4 minutes; P < 0.01 for scribe visits, but time of patient interaction (without computer was greater (6.7 ± 2.1 versus 1.5 ± 1.9 minutes; P < 0.01. Subjective assessment of physician–patient interaction (1–10 was higher (P < 0.01 on scribe visits (9.1 ± 0.9 versus 7.9 ± 1.1. Direct and indirect (downstream revenue per patient seen was $142 and $2,398, with $205,740 additional revenue generated from the 81 additional patients seen with scribes. Conclusion: Using scribes in a cardiology clinic is feasible, produces improvements in physician–patient interaction, and results in large increases in physician productivity and system cardiovascular revenue. Keywords: physician productivity, medical economics, patient

  17. Perceptions of Prospective Teachers about Tolerance Education

    Science.gov (United States)

    Sahin, Cavus

    2011-01-01

    The purpose of this study is to ascertain the perceptions of prospective teachers about tolerance education. This research is a descriptive, qualitative study. A semi-structured and non-directive interview technique is used for collecting data. Research is carried out with 30 prospective teachers who attend Canakkale Onsekiz Mart University…

  18. Anterior cervical discectomy with or without fusion with ray titanium cage: a prospective randomized clinical study

    DEFF Research Database (Denmark)

    Hauerberg, J.; Kosteljanetz, M.; Bøge-Rasmussen, Torben

    2008-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE: To compare 2 surgical methods in the treatment of cervical radiculopathy caused by hard or soft disc herniation; namely, simple discectomy versus discectomy with an additional interbody fusion with a Ray titanium cage. SUMMARY...... by fusion with a Ray titanium cage (40 patients) or to discectomy alone (46 patients). Clinical and radiologic follow-up was performed 3, 12, and 24 months after surgery. RESULTS: There was no statistically significant difference between the 2 groups concerning self-reported satisfaction or severity of pain...... adjacent disc degeneration or spondylosis were the same in both groups. CONCLUSION: This study showed no statistically significant difference between simple discectomy and discectomy followed by interbody fusion with a titanium cage in the surgical treatment of cervical radiculopathy caused by disc...

  19. Endoscopic Management of Pancreatic Fluid Collections in Children.

    Science.gov (United States)

    Nabi, Zaheer; Talukdar, Rupjyoti; Reddy, D Nageshwar

    2017-07-15

    The incidence of acute pancreatitis in children has increased over the last few decades. The development of pancreatic fluid collection is not uncommon after severe acute pancreatitis, although its natural course in children and adolescents is poorly understood. Asymptomatic fluid collections can be safely observed without any intervention. However, the presence of clinically significant symptoms warrants the drainage of these fluid collections. Endoscopic management of pancreatic fluid collection is safe and effective in adults. The use of endoscopic ultrasound (EUS)-guided procedure has improved the efficacy and safety of drainage of pancreatic fluid collections, which have not been well studied in pediatric populations, barring a scant volume of small case series. Excellent results of EUS-guided drainage in adult patients also need to be verified in children and adolescents. Endoprostheses used to drain pancreatic fluid collections include plastic and metal stents. Metal stents have wider lumens and become clogged less often than plastic stents. Fully covered metal stents specifically designed for pancreatic fluid collection are available, and initial studies have shown encouraging results in adult patients. The future of endoscopic management of pancreatic fluid collection in children appears promising. Prospective studies with larger sample sizes are required to establish their definitive role in the pediatric age group.

  20. The Swiss Multiple Sclerosis Cohort-Study (SMSC: A Prospective Swiss Wide Investigation of Key Phases in Disease Evolution and New Treatment Options.

    Directory of Open Access Journals (Sweden)

    Giulio Disanto

    Full Text Available The mechanisms leading to disability and the long-term efficacy and safety of disease modifying drugs (DMDs in multiple sclerosis (MS are unclear. We aimed at building a prospective cohort of MS patients with standardized collection of demographic, clinical, MRI data and body fluids that can be used to develop prognostic indicators and biomarkers of disease evolution and therapeutic response. The Swiss MS Cohort (SMSC is a prospective observational study performed across seven Swiss MS centers including patients with MS, clinically isolated syndrome (CIS, radiologically isolated syndrome or neuromyelitis optica. Neurological and radiological assessments and biological samples are collected every 6-12 months. We recruited 872 patients (clinically isolated syndrome [CIS] 5.5%, relapsing-remitting MS [RRMS] 85.8%, primary progressive MS [PPMS] 3.5%, secondary progressive MS [SPMS] 5.2% between June 2012 and July 2015. We performed 2,286 visits (median follow-up 398 days and collected 2,274 serum, plasma and blood samples, 152 cerebrospinal fluid samples and 1,276 brain MRI scans. 158 relapses occurred and expanded disability status scale (EDSS scores increased in PPMS, SPMS and RRMS patients experiencing relapses. Most RRMS patients were treated with fingolimod (33.4%, natalizumab (24.5% or injectable DMDs (13.6%. The SMSC will provide relevant information regarding DMDs efficacy and safety and will serve as a comprehensive infrastructure available for nested research projects.

  1. Intrapartum amnioinfusion for meconium-stained fluid: meta-analysis of prospective clinical trials.

    Science.gov (United States)

    Pierce, J; Gaudier, F L; Sanchez-Ramos, L

    2000-06-01

    To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0. 46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.

  2. Security approaches in using tablet computers for primary data collection in clinical research.

    Science.gov (United States)

    Wilcox, Adam B; Gallagher, Kathleen; Bakken, Suzanne

    2013-01-01

    Next-generation tablets (iPads and Android tablets) may potentially improve the collection and management of clinical research data. The widespread adoption of tablets, coupled with decreased software and hardware costs, has led to increased consideration of tablets for primary research data collection. When using tablets for the Washington Heights/Inwood Infrastructure for Comparative Effectiveness Research (WICER) project, we found that the devices give rise to inherent security issues associated with the potential use of cloud-based data storage approaches. This paper identifies and describes major security considerations for primary data collection with tablets; proposes a set of architectural strategies for implementing data collection forms with tablet computers; and discusses the security, cost, and workflow of each strategy. The paper briefly reviews the strategies with respect to their implementation for three primary data collection activities for the WICER project.

  3. Decreased Lung Perfusion After Breast/Chest Wall Irradiation: Quantitative Results From a Prospective Clinical Trial

    Energy Technology Data Exchange (ETDEWEB)

    Liss, Adam L., E-mail: adamliss68@gmail.com [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Marsh, Robin B. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Kapadia, Nirav S. [Department of Radiation Oncology, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (United States); McShan, Daniel L. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Rogers, Virginia E. [Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, Michigan (United States); Balter, James M.; Moran, Jean M.; Brock, Kristy K.; Schipper, Matt J.; Jagsi, Reshma [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States); Griffith, Kent A. [Biostatistics Unit, University of Michigan, Ann Arbor, Michigan (United States); Flaherty, Kevin R. [Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan (United States); Frey, Kirk A. [Division of Nuclear Medicine, Department of Radiology, University of Michigan, Ann Arbor, Michigan (United States); Pierce, Lori J. [Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan (United States)

    2017-02-01

    Purpose: To quantify lung perfusion changes after breast/chest wall radiation therapy (RT) using pre- and post-RT single photon emission computed tomography/computed tomography (SPECT/CT) attenuation-corrected perfusion scans; and correlate decreased perfusion with adjuvant RT dose for breast cancer in a prospective clinical trial. Methods and Materials: As part of an institutional review board–approved trial studying the impact of RT technique on lung function in node-positive breast cancer, patients received breast/chest wall and regional nodal irradiation including superior internal mammary node RT to 50 to 52.2 Gy with a boost to the tumor bed/mastectomy scar. All patients underwent quantitative SPECT/CT lung perfusion scanning before RT and 1 year after RT. The SPECT/CT scans were co-registered, and the ratio of decreased perfusion after RT relative to the pre-RT perfusion scan was calculated to allow for direct comparison of SPECT/CT perfusion changes with delivered RT dose. The average ratio of decreased perfusion was calculated in 10-Gy dose increments from 0 to 60 Gy. Results: Fifty patients had complete lung SPECT/CT perfusion data available. No patient developed symptoms consistent with pulmonary toxicity. Nearly all patients demonstrated decreased perfusion in the left lung according to voxel-based analyses. The average ratio of lung perfusion deficits increased for each 10-Gy increment in radiation dose to the lung, with the largest changes in regions of lung that received 50 to 60 Gy (ratio 0.72 [95% confidence interval 0.64-0.79], P<.001) compared with the 0- to 10-Gy region. For each increase in 10 Gy to the left lung, the lung perfusion ratio decreased by 0.06 (P<.001). Conclusions: In the assessment of 50 patients with node-positive breast cancer treated with RT in a prospective clinical trial, decreased lung perfusion by SPECT/CT was demonstrated. Our study allowed for quantification of lung perfusion defects in a prospective cohort of

  4. Correlation of clinical, radiographic, and surgical localization of intervertebral disc extrusion in small-breed dogs: a prospective study of 50 cases

    International Nuclear Information System (INIS)

    Schulz, K.S.; Walker, M.; Moon, M.; Waldron, D.; Slater, M.; McDonald, D.E.

    1998-01-01

    Objective-To compare prospectively clinical, radiographic, and surgical findings of intervertebral disc extrusion (IDE) localization in small-breed dogs and to determine the best means of lesion localization for the purpose of hemilaminectomy. Study Design-Clinical, radiographic, and surgical findings of small-breed dogs with thoracolumbar IDE were prospectively compared for agreement on lesion localization. Sample Population-50 small-breed dogs with IDE treated at the three participating veterinary hospitals were included in the study if no other confounding diseases were identified and if the owner gave permission for diagnostic tests and surgery. Methods-Clinical and surgical findings were recorded by the surgeon assigned to the case. Radiographic studies were evaluated independently by two radiologists blinded as to the clinical and surgical findings. K values and 95% confidence intervals were calculated for agreement on lesion localization by clinical, radiographic, and surgical means and for agreement between radiologists. Results-K values for agreement of lesion localization were as follows: clinical versus surgical, 0.595; radiologist A versus radiologist B, 0.81; radiologist A versus surgical findings, 0.60; radiologist B versus surgical findings, 0.71. Both radiologists interpretation of IDE localization agreed with surgical localization in 60% of cases. Conclusions-Clinical lateralization of IDE was found to be the least reliable factor of those studied for determining on which side the hemilaminectomy should be performed. Results of this study differ from those of previous studies examining the reliability of myelography to localize the site of IDE accurately. The results of this study further suggest that surgery may not be an absolute standard for determination of the localization of IDE in small-breed dogs. Clinical Relevance-Intervertebral disc extrusion in small-breed dogs frequently results in bilateral distribution of extruded material. Computed

  5. VISLISI trial, a prospective clinical study allowing identification of a new metalloprotease and putative virulence factor from Staphylococcus lugdunensis.

    Science.gov (United States)

    Argemi, X; Prévost, G; Riegel, P; Keller, D; Meyer, N; Baldeyrou, M; Douiri, N; Lefebvre, N; Meghit, K; Ronde Oustau, C; Christmann, D; Cianférani, S; Strub, J M; Hansmann, Y

    2017-05-01

    Staphylococcus lugdunensis is a coagulase-negative staphylococcus that displays an unusually high virulence rate close to that of Staphylococcus aureus. It also shares phenotypic properties with S. aureus and several studies found putative virulence factors. The objective of the study was to describe the clinical manifestations of S. lugdunensis infections and investigate putative virulence factors. We conducted a prospective study from November 2013 to March 2016 at the University Hospital of Strasbourg. Putative virulence factors were investigated by clumping factor detection, screening for proteolytic activity, and sequence analysis using tandem nano-liquid chromatography-mass spectrometry. In total, 347 positive samples for S. lugdunensis were collected, of which 129 (37.2%) were from confirmed cases of S. lugdunensis infection. Eighty-one of these 129 patients were included in the study. Bone and prosthetic joints (PJI) were the most frequent sites of infection (n=28; 34.6%) followed by skin and soft tissues (n=23; 28.4%). We identified and purified a novel protease secreted by 50 samples (61.7%), most frequently associated with samples from deep infections and PJI (pr 0.97 and pr 0.91, respectively). Protease peptide sequencing by nano-liquid chromatography-mass spectrometry revealed a novel protease bearing 62.42% identity with ShpI, a metalloprotease secreted by Staphylococcus hyicus. This study confirms the pathogenicity of S. lugdunensis, particularly in bone and PJI. We also identified a novel metalloprotease called lugdulysin that may contribute to virulence. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  6. Clinic Attendance for Medication Refills and Medication Adherence amongst an Antiretroviral Treatment Cohort in Uganda: A Prospective Study

    Directory of Open Access Journals (Sweden)

    Setor Kunutsor

    2010-01-01

    Full Text Available Background. Regular clinic attendance for antiretroviral (ARV drug refills is important for successful clinical outcomes in HIV management. Methods. Clinic attendance for ARV drug refills and medication adherence using a clinic-based pill count in 392 adult patients receiving antiretroviral therapy (ART in a district hospital in Uganda were prospectively monitored over a 28-week period. Results. Of the 2267 total scheduled clinic visits, 40 (1.8% were missed visits. Among the 392 clients, 361 (92% attended all appointments for their refills (regular attendance. Clinic attendance for refills was statistically significantly associated with medication adherence with regular attendant clients having about fourfold greater odds of achieving optimal (≥95% medication adherence [odds ratio (OR=3.89, 95% CI: 1.48 to 10.25, exact P=.013]. In multivariate analysis, clients in age category 35 years and below were less likely to achieve regular clinic attendance. Conclusion. Monitoring of clinic attendance may be an objective and effective measure and could be a useful adjunct to an adherence measure such as pill counting in resource-constrained settings. Where human resource constraints do not allow pill counts or other time-consuming measures, then monitoring clinic attendance and acting on missed appointments may be an effective proxy measure.

  7. Turkish Prospective Chemistry Teachers' Alternative Conceptions about Acids and Bases

    Science.gov (United States)

    Boz, Yezdan

    2009-01-01

    The purpose of this study was to obtain prospective chemistry teachers' conceptions about acids and bases concepts. Thirty-eight prospective chemistry teachers were the participants. Data were collected by means of an open-ended questionnaire and semi-structured interviews. Analysis of data indicated that most prospective teachers did not have…

  8. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study

    OpenAIRE

    Abuaf, Ozlem Karabudak; Yildiz, Hamza; Baloglu, H?seyin; Bilgili, Memet Ersan; Simsek, Hasan Aktug; Dogan, Bilal

    2016-01-01

    Background Platelet-rich plasma (PRP) is an autologous concentration of human platelets contained in a small volume of plasma and has recently been shown to accelerate rejuvenate aging skin by various growth factors and cell adhesion molecules. Objective This study was conducted to evaluate the efficacy and safety of intradermal injection of PRP in the human facial rejuvenation. Methods This study was a prospective, single-center, single-dose, open-label, non-randomized controlled clinical st...

  9. Prospective clinical trial of surgical intervention for painful rib fracture nonunion.

    Science.gov (United States)

    Fabricant, Loic; Ham, Bruce; Mullins, Richard; Mayberry, John

    2014-06-01

    We performed a prospective clinical trial of resection with or without plate fixation for symptomatic rib fracture nonunion three or more months postinjury with 6-month postoperative followup. The McGill Pain Questionnaire (MPQ) and RAND 36 Health Survey were administered and activity level (sedentary, ambulatory, moderately active, vigorous), functional status (disabled, nonphysical labor, physical labor), and work status (employed, unemployed, retired, student) were queried pre- and postoperatively. Twenty-four patients 4 to 197 months (median, 16 months) postinjury underwent surgical intervention for one to four rib fracture nonunions (median, two nonunions). Evidence of intercostal nerve entrapment was present in nine patients (38%). MPQ Present Pain Intensity and Pain Rating Index and RAND 36 Physical Functioning, Role Physical, Social Functioning, Role Social, Bodily Pain, Vitality, Mental Health, and General Health were significantly improved at six months compared with study entry (P rib fracture nonunion may improve chronic pain and disability but without change in functional or work status. Resection of adjacent nonunions with significant gaps may lead to chest wall hernia.

  10. Admissions to acute adolescent psychiatric units: a prospective study of clinical severity and outcome

    Directory of Open Access Journals (Sweden)

    Jensen Gunnar

    2011-01-01

    Full Text Available Abstract Background Several countries have established or are planning acute psychiatric in-patient services that accept around-the-clock emergency admission of adolescents. Our aim was to investigate the characteristics and clinical outcomes of a cohort of patients at four Norwegian units. Methods We used a prospective pre-post observational design. Four units implemented a clinician-rated outcome measure, the Health of the Nation Outcome Scales for Children and Adolescents (HoNOSCA, which measures mental health problems and their severity. We collected also data about the diagnoses, suicidal problems, family situations, and the involvement of the Child Protection Service. Predictions of outcome (change in HoNOSCA total score were analysed with a regression model. Results The sample comprised 192 adolescents admitted during one year (response rate 87%. Mean age was 15.7 years (range 10-18 and 70% were girls. Fifty-eight per cent had suicidal problems at intake and the mean intake HoNOSCA total score was 18.5 (SD 6.4. The largest groups of main diagnostic conditions were affective (28% and externalizing (26% disorders. Diagnoses and other patient characteristics at intake did not differ between units. Clinical psychiatric disorders and developmental disorders were associated with severity (on HoNOSCA at intake but not with outcome. Of adolescents ≥ 16 years, 33% were compulsorily admitted. Median length of stay was 8.5 days and 75% of patients stayed less than a month. Compulsory admissions and length of stay varied between units. Mean change (improvement in the HoNOSCA total score was 5.1 (SD 6.2, with considerable variation between units. Mean discharge score was close to the often-reported outpatient level, and self-injury and emotional symptoms were the most reduced symptoms during the stay. In a regression model, unit, high HoNOSCA total score at intake, or involvement of the Child Protection Service predicted improvement during admission

  11. MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial.

    Science.gov (United States)

    Hanser, Thomas; Doliveux, Romain

    The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible. Using a randomized protocol, bone blocks were harvested with the MicroSaw and Piezosurgery either from the right or the left side. Clinical outcome parameters were the comparison of osteotomy time; volume of block graft; and clinical determination of intraoperative complications such as hemorrhage, nerve injury, pain, swelling, and healing of the donor site. The mean osteotomy time for harvesting including luxating a bone block was 5.63 (± 1.37) minutes using the MicroSaw and 16.47 (± 2.74) minutes using Piezosurgery (P .05). Swelling did not appear significantly different either (P > .05), and none of the donor sites showed primary healing complications. The data described in this randomized prospective split-mouth clinical trial indicate that the MicroSaw and Piezosurgery allowed efficient and safe bone block harvesting from the external oblique ridge. Clinically, concerning harvesting time and volume of the grafts, the MicroSaw performed significantly better, whereas pain, swelling, and healing did not appear to be considerably different. Given the improved visibility, precise cut geometries, and the margin of safety afforded by the MicroSaw and Piezosurgery, they are both instruments of choice when harvesting bone from the retromolar area.

  12. Current status and future prospects of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) clinical trials in ovarian cancer.

    Science.gov (United States)

    Cowan, Renee A; O'Cearbhaill, Roisin E; Zivanovic, Oliver; Chi, Dennis S

    2017-08-01

    The natural history of advanced-stage epithelial ovarian cancer is one of clinical remission after surgery and platinum/taxane-based intravenous (IV) and/or intraperitoneal (IP) chemotherapy followed by early or late recurrence in the majority of patients. Prevention of progression and recurrence remains a major hurdle in the management of ovarian cancer. Recently, many investigators have evaluated the use of normothermic and hyperthermic intraoperative IP drug delivery as a management strategy. This is a narrative review of the current status of clinical trials of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) in ovarian cancer and the future directions for this treatment strategy. The existing studies on HIPEC in patients with epithelial ovarian cancer are mostly retrospective in nature, are heterogeneous with regards to combined inclusion of primary and recurrent disease and lack unbiased data. Until data are available from evidence-based trials, it is reasonable to conclude that surgical cytoreduction and HIPEC is a rational and interesting, though still investigative, approach in the management of epithelial ovarian cancer, whose use should be employed within prospective clinical trials.

  13. Feasibility of the collection of patient-reported outcomes in an ambulatory neurology clinic.

    Science.gov (United States)

    Moura, Lidia M V R; Schwamm, Eli; Moura Junior, Valdery; Seitz, Michael P; Hsu, John; Cole, Andrew J; Schwamm, Lee H

    2016-12-06

    To determine whether patients could self-report physical and mental health assessments in the waiting room and whether these assessments would be associated with modified Rankin Scale (mRS) and Quality of Life in Epilepsy (QOLIE-10) scores. We offered iPad-based surveys to consecutive adult neurology patients at check-in to collect patient-reported outcome measures (PROMs). We collected demographic and clinical data on 6,075 patients through survey or administrative claims and PROMs from participating patients. We compared demographic characteristics of participants and nonparticipants and tested associations between physical and mental health scores and mRS and QOLIE-10. Of 6,075 patients seen by neurologists during the study period, 2,992 (49.3%) participated in the survey. Compared to nonparticipating patients, participating patients more often were privately insured (53.5% vs 42.7%, p neurology (nonsubspecialty) clinics (53.1% vs 46.6%, p Neurology.

  14. Thyroid Autoantibodies and the Clinical Presentation of Moyamoya Disease: A Prospective Study.

    Science.gov (United States)

    Lanterna, Luigi A; Galliani, Silvia; Zangari, Rosalia; Conti, Luciano; Brembilla, Carlo; Gritti, Paolo; Colleoni, Maria Luisa; Bernucci, Claudio

    2018-05-01

    Moyamoya is a rare cerebrovascular disease characterized by the progressive occlusion of the intracranial carotid artery. Thyroid autoantibodies have been found to be associated with the disease, but their clinical significance has never been studied. The objective of this study was to investigate the relationship between thyroid autoantibodies and the clinical presentation of moyamoya. This is a prospective study including 37 patients with moyamoya disease (MMD) or unilateral moyamoya (uMM). Thyroid function and thyroid autoantibodies (e.g., antithyroperoxidase and antithyroglobulin) were investigated. We studied the effect of gender, age, type of moyamoya (uMM versus MMD), and thyroid autoantibodies on the clinical presentation, dichotomized into aggressive (hemorrhage, major stroke, or frequent transient ischemic attack [TIA]) and nonaggressive presentation (headache, rare TIAs, and incidental diagnosis) according to the criteria of the Research Committee on Spontaneous Occlusion of the Circle of Willis. Of the 37 patients included in the study, the autoantibodies were elevated in 9 (24.3%). An aggressive presentation occurred in 21 patients (hemorrhage in 11, major stroke in 9, frequent TIAs in 1). The autoantibodies were elevated in 8 of the 21 patients (38.09%) with an aggressive presentation and in 1 of those presenting with minor symptoms (6.2%). The presence of elevated autoantibodies was the only variable associated with an aggressive presentation in the multivariate logistic analysis (P = .048). When the serum concentration of the thyroid autoantibodies is increased, the patients have a higher risk of an aggressive presentation. Our results support the hypothesis that activation of immune-mediated processes affects the moyamoya physiopathology. Copyright © 2018 National Stroke Association. Published by Elsevier Inc. All rights reserved.

  15. Concordance of mutation detection in circulating tumor DNA in early clinical trials using different blood collection protocols

    DEFF Research Database (Denmark)

    Ahlborn, Lise B.; Madsen, Mette; Jonson, Lars

    2017-01-01

    in a clinical setting. Here we investigate the concordance between standard blood collection for molecular analysis using immediate separation of plasma, compared to the use of collection tubes allowing for delayed processing. Methods: In this study, we measured the fractional abundance of tumor specific...... patients with advanced solid cancers enrolled in early clinical trials. Results: Concordance in the fractional abundance of mutations in ctDNA isolated from blood collected in either K3EDTA or BCT tubes from patients with different solid cancers was observed. Conclusions: This study indicates that BCT...... mutations (BRAF p.V600E and PIK3CA p.H1047R) in ctDNA isolated from blood samples collected in either cell-stabilizing Cell-Free DNA BCT tubes (delayed processing within 72 hours) or standard K3EDTA tubes (immediate processing within 15 minutes). Twenty-five blood sample pairs (EDTA/BCT) were collected from...

  16. World Endometriosis Research Foundation Endometriosis Phenome and biobanking harmonization project: II. Clinical and covariate phenotype data collection in endometriosis research

    DEFF Research Database (Denmark)

    Vitonis, Allison F.; Vincent, Katy; Rahmioglu, Nilufer

    2014-01-01

    ObjectiveTo harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration.......ObjectiveTo harmonize the collection of nonsurgical clinical and epidemiologic data relevant to endometriosis research, allowing large-scale collaboration....

  17. Therapeutic horticulture in clinical depression: a prospective study of active components.

    Science.gov (United States)

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2010-09-01

    This paper is a report of a study conducted to assess change in depression severity, perceived attentional capacity and rumination (brooding) in individuals with clinical depression during a therapeutic horticulture programme and to investigate if the changes were mediated by experiences of being away and fascination. Individuals with clinical depression suffer from distortion of attention and rumination. Interventions can help to disrupt maladaptive rumination and promote restoration of depleted attentional capacity. A single-group study was conducted with a convenience sample of 28 people with clinical depression in 2009. Data were collected before, twice during, and immediately after a 12-week therapeutic horticulture programme, and at 3-month follow-up. Assessment instruments were the Beck Depression Inventory, Attentional Function Index, Brooding Scale, and Being Away and Fascination subscales from the Perceived Restorativeness Scale. Mean Beck Depression Inventory scores declined by 4.5 points during the intervention (F = 5.49, P = 0.002). The decline was clinically relevant for 50% of participants. Attentional Function Index scores increased (F = 4.14, P = 0.009), while Brooding scores decreased (F = 4.51, P = 0.015). The changes in Beck Depression Inventory and Attentional Function Index scores were mediated by increases in Being Away and Fascination, and decline in Beck Depression Inventory scores was also mediated by decline in Brooding. Participants maintained their improvements in Beck Depression Inventory scores at 3-month follow-up. Being away and fascination appear to work as active components in a therapeutic horticulture intervention for clinical depression.

  18. Doses of olanzapine, risperidone, and haloperidol used in clinical practice: results of a prospective pharmacoepidemiologic study. EFESO Study Group. Estudio Farmacoepidemiologico en la Esquizofrenia con Olanzapina.

    Science.gov (United States)

    Sacristán, J A; Gómez, J C; Montejo, A L; Vieta, E; Gregor, K J

    2000-05-01

    The objectives of this study were to determine the doses of olanzapine (OLZ), risperidone (RIS), and haloperidol (HAL) used in clinical practice in outpatients with schizophrenia and the rates of occurrence of extrapyramidal symptoms (EPS) and other adverse events, clinical response, and use of concomitant medications. The present study involved a subset of patients from a 6-month, open-label, prospective observational study. Data were collected by 293 psychiatrists at mental health centers and other outpatient treatment facilities in Spain. Medications and doses used, occurrence of EPS and other adverse events, and scores on the Clinical Global Impression (CGI) of Severity Scale and Global Assessment of Function (GAF) were recorded. Clinical response was defined as a decrease of > or = 2 points on the CGI, with a final CGI score or = 5 received significantly higher overall mean daily doses than did patients with an initial CGI score < 5 (P < 0.001). A significantly lower proportion of OLZ-treated patients (10.2%) were receiving concomitant anticholinergic medication at the end of the study (month 6) compared with RIS-treated (19.9%) and HAL-treated (44.0%) patients (P < 0.001). The mean daily doses recorded in this analysis based on data from a naturalistic setting are consistent with recommendations based on clinical trials. Compared with both RIS- and HAL-treated patients, OLZ-treated patients were less likely to experience EPS or other adverse events, and less likely to use concomitant anticholinergic medications. OLZ-treated patients were also more likely to respond to treatment than were RIS-treated patients.

  19. Resource utilization in home health care: results of a prospective study.

    Science.gov (United States)

    Trisolini, M G; Thomas, C P; Cashman, S B; Payne, S M

    1994-01-01

    Resource utilization in home health care has become an issue of concern due to rising costs and recent initiatives to develop prospective payment systems for home health care. A number of issues remain unresolved for the development of prospective reimbursement in this sector, including the types of variables to be included as payment variables and appropriate measures of resource use. This study supplements previous work on home health case-mix by analyzing the factors affecting one aspect of resource use for skilled nursing visits--visit length--and explores the usefulness of several specially collected variables which are not routinely available in administrative records. A data collection instrument was developed with a focus group of skilled nurses, identifying a range of variables hypothesized to affect visit length. Five categories of variables were studied using multiple regression analysis: provider-related; patient's socio-economic status; patient's clinical status; patient's support services; and visit-specific. The final regression model identifies 9 variables which significantly affect visit time. Five of the 9 are visit-specific variables, a significant finding since these are not routinely collected. Case-mix systems which include visit time as a measure of resource use will need to investigate visit-specific variables, as this study indicates they could have the largest influence on visit time. Two other types of resources used in home health care, supplies and security drivers, were also investigated in less detail.

  20. Comparison of clinical judgment and diagnostic ultrasonography in the diagnosis of acute appendicitis

    DEFF Research Database (Denmark)

    Jahn, H; Mathiesen, F K; Neckelmann, K

    1997-01-01

    , and diagnostic aids are desirable to reduce the negative appendicectomy rate. Diagnostic US performed poorly as a routine procedure. Application of an up to date scoring system might be of some help to patients with a high or low probability of acute appendicitis, but any conclusion about its clinical......OBJECTIVE: To evaluate the diagnostic accuracy of clinical judgment and diagnostic ultrasonography (US) used routinely and to create a scoring system to aid diagnosis. DESIGN: Prospective, double-blind study. SETTING: University hospital, Denmark. SUBJECTS: 222 Consecutive patients suspected...... of having acute appendicitis admitted between 0800 and midnight from June 1990 to June 1992. INTERVENTIONS: 148 Patients (67%) underwent appendicectomy and the remaining 74 patients were observed. 193 Patients (87%) had a diagnostic US examination. 21 Predictive variables were collected prospectively...

  1. A 3-year prospective clinical study of telescopic crown, bar, and locator attachments for removable four implant-supported maxillary overdentures.

    Science.gov (United States)

    Zou, Duohong; Wu, Yiqun; Huang, Wei; Wang, Feng; Wang, Shen; Zhang, Zhiyong; Zhang, Zhiyuan

    2013-01-01

    To evaluate telescopic crown (TC), bar, and locator attachments used in removable four implant-supported overdentures for patients with edentulous maxillae. A total of 30 maxillary edentulous patients were enrolled in a 3-year prospective study. Ten patients (group A) were treated with overdentures supported by TCs, 10 patients (group B) with overdentures supported by bar attachments, and 10 patients (group C) with overdentures supported by locator attachments. A total of 120 implants were used to restore oral function. During the 3-year follow-up period, implant survival and success rates, biologic and mechanical complications, prosthodontic maintenance efforts, and patient satisfaction were evaluated. All 30 patients were available for the 3-year follow-up and exhibited 100% implant survival and success rates. Peri-implant marginal bone resorption was not statistically significant for the three groups. There were lower plaque, bleeding, gingiva, and calculus indices in group C compared with groups A and B. The number of prosthodontic maintenance visits revealed eight complications in the TC group, seven complications in the bar group, and four complications in the locator group. However, there were no differences in the clinical effects of the overdentures in the three groups. Within the limits of this prospective study, it was concluded that the locator system produced superior clinical results compared with the TC and bar attachments in terms of peri-implant hygiene parameters, the frequency of prosthodontic maintenance measures, cost, and ease of denture preparation. However, longer-term prospective studies are required to confirm these results.

  2. Bioinformatics Methods for Learning Radiation-Induced Lung Inflammation from Heterogeneous Retrospective and Prospective Data

    Directory of Open Access Journals (Sweden)

    Sarah J. Spencer

    2009-01-01

    archives. In addition, biomarkers for this model are extracted from a prospective clinical trial that collects blood serum samples at multiple time points. We utilize a 3-way proteomics methodology to screen for differentially expressed proteins that are related to RP. Our preliminary results demonstrate that kernel methods can capture nonlinear dose-volume interactions, but fail to address missing biological factors. Our proteomics strategy yielded promising protein candidates, but their role in RP as well as their interactions with dose-volume metrics remain to be determined.

  3. International, multi-center standardization of acute graft-versus-host disease clinical data collection: a report from the MAGIC consortium

    Science.gov (United States)

    Harris, Andrew C.; Young, Rachel; Devine, Steven; Hogan, William J.; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A.; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S.; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L.M.; Levine, John E.

    2015-01-01

    Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and non-relapse mortality following allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed upon by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multi-center clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance was following discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture which may improve the reproducibility of GVHD clinical trials after further prospective validation. PMID:26386318

  4. Disc pathology after whiplash injury. A prospective magnetic resonance imaging and clinical investigation.

    Science.gov (United States)

    Pettersson, K; Hildingsson, C; Toolanen, G; Fagerlund, M; Björnebrink, J

    1997-02-01

    This study was used to evaluate the relationship between magnetic resonance imaging findings and clinical findings after whiplash injury. To identify initial soft-tissue damage after whiplash injury, the development of disc pathology, and the relationship of disc pathology to clinical findings. Although a few studies have reported pathological magnetic resonance imaging findings after whiplash injuries, there is no prospective study published to our knowledge. Thirty-nine patients, 20 women and 19 men with a mean age of 32 years, were treated for whiplash injury. Magnetic resonance imaging and clinical examination were performed in a blinded manner at a mean of 11 days after trauma. The procedure was repeated at a 2-year follow-up visit. Two patients could not be examined with the second magnetic resonance imaging because of claustrophobia and pregnancy, respectively. The authors found 13 patients (33%) with disc herniations with medullary (six cases) or dura (seven cases) impingement over the 2-year follow-up period. At the follow-up examination all patients with medullary impingement had persistent or increased symptoms, and three of 27 patients (11%) with no or slight changes on magnetic resonance imaging had persistent symptoms. No ligament injuries were diagnosed. Although disc pathology seems to be one contributing factor in the development of chronic symptoms after whiplash injury, it may be unnecessary to examine these patients in the acute phase with magnetic resonance imaging; correlating initial symptoms and signs to magnetic resonance imaging findings is difficult because of the relatively high proportion of false-positive results. Magnetic resonance imaging is indicated later in the course of treatment in patients with persistent arm pain, neurologic deficits or clinical signs of nerve root compression to diagnose disc herniations requiring surgery.

  5. Do Clinical and Radiological Assessments Contribute to the Understanding of Biomaterials? Results From a Prospective Randomized Sinus Augmentation Split-Mouth Trial.

    Science.gov (United States)

    Lorenz, Jonas; Korzinskas, Tadas; Chia, Poju; Maawi, Sarah Al; Eichler, Katrin; Sader, Robert A; Ghanaati, Shahram

    2018-02-01

    The present prospective randomized split-mouth trial reports on the 3-year clinical and radiological follow-up investigation of implants placed 7 months after sinus augmentation with 2 different bone substitute materials. The aim of the study was to complete the histologic observation of cellular reactions by analyses of the implants and the volumetric changes of the augmented bone substitute materials. A sinus augmentation split-mouth trial was performed in 14 patients with the synthetic bone substitute material Nanobone (NB) and the xenogeneic Bio-Oss (BO). Changes in volume and density of the augmented biomaterials were investigated by analysis of computed tomography scans, taken immediately after augmentation and after 7 months. Clinical implant parameters were assessed after 3 years of loading. Both bone substitute materials underwent nonsignificant volume reduction and significant increase in bone density over an integration period of 7 months. No significant differences concerning volume and bone density were observed between the groups. Three years after loading, 51 of 53 implants were in situ with no peri-implant infections, and only a few soft-tissue variations were present. The present prospective randomized study showed that no differences could be observed clinically and radiologically. Accordingly, it seems that both biomaterials, independent of their physicochemical composition, enable clinical success and long-time stability for dental implants. Interestingly, the histological results showed distinct differences in cellular reactions: While the xenogeneic BO induced a mild tissue reaction with only few multinucleated giant cells and comparably low vascularization, the synthetic NB induced a multinucleated giant cell-triggered tissue reaction with an increase of vascularization. Thus, the present study showed that a combination analysis-histological, clinical, and radiological-is necessary for a detailed assessment of a biomaterial's quality for

  6. Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials.

    Science.gov (United States)

    Mhlanga, Felix G; Noguchi, Lisa; Balkus, Jennifer E; Kabwigu, Samuel; Scheckter, Rachel; Piper, Jeanna; Watts, Heather; O'Rourke, Colin; Torjesen, Kristine; Brown, Elizabeth R; Hillier, Sharon L; Beigi, Richard

    2018-02-01

    Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.

  7. Parvovirus B19 infection in pregnancy: maternal and fetal viral load measurements related to clinical parameters

    NARCIS (Netherlands)

    de Haan, Timo R.; Beersma, Matthijs F. C.; Oepkes, Dick; de Jong, Eveline P.; Kroes, Aloys C. M.; Walther, Frans J.

    2007-01-01

    To correlate quantitative maternal and fetal parvovirus B19 (B19V) viral loads and antibody levels at intrauterine transfusion (IUT) as a predictor of fetal morbidity. Prospectively collected clinical data and quantitative B19V viral load and specific IgM and IgG values in fetal and maternal blood

  8. Short-Term Prospective Clinical Evaluation of Monolithic and Partially Veneered Zirconia Single Crowns.

    Science.gov (United States)

    Bömicke, Wolfgang; Rammelsberg, Peter; Stober, Thomas; Schmitter, Marc

    2017-02-01

    The purpose of this study was to prospectively evaluate the short-term clinical performance and esthetics of monolithic and partially (i.e., facially) veneered zirconia single crowns (MZC and PZC, respectively). Between September 2011 and June 2013, 68 participants received 90 MZCs and 72 PZCs. Clinical study documentation was performed at crown cementation (baseline), at the 6-month follow-up, and then yearly thereafter using standardized report forms. Eight participants with 14 single crowns (eight MZCs and six PZCs) dropped out during clinical follow-up. Thus, 60 participants (28 male, mean age 62.5 ± 13.1 years) fitted with 82 MZCs and 66 PZCs were analyzed in February 2016 (Kaplan-Meier survival; mean observation time for the restorations 35.1 ± 6.3 months). Descriptive statistics were calculated for participants' and dentists' esthetic ratings on a numerical rating scale from 0 to 10 (0 = unacceptable color and shape; 10 = excellent color and shape). Complications were predominantly biological in nature. One PZC was affected by minor chipping. Cumulative 3-year failure-free survival was 98.5% (standard error (SE), 1.5%) for both MZCs and PZCs. Three-year cumulative complication-free survival (success) was 93.6% (SE 2.8%) for MZCs and 95.5% (SE 2.6%) for PZCs. Three-year cumulative fracture-free survival was 100% for MZCs and 98.5% (SE 1.5%) for PZCs. Crowns of both types were awarded high esthetic scores by participants and dentists. Monolithic and partially veneered zirconia crowns can be used clinically with excellent short-term survival and success and without compromising esthetic appearance. Longer-term follow-up is, however, desirable. During the observation time, both monolithic and partially veneered zirconia crowns showed an outstanding low technical complication rate: only one minor chipping and three losses of retention were observed. Additionally, esthetics was excellent. Based on these results the clinical use of this kind of

  9. Current concepts in clinical research: web-based, automated, arthroscopic surgery prospective database registry.

    Science.gov (United States)

    Lubowitz, James H; Smith, Patrick A

    2012-03-01

    In 2011, postsurgical patient outcome data may be compiled in a research registry, allowing comparative-effectiveness research and cost-effectiveness analysis by use of Health Insurance Portability and Accountability Act-compliant, institutional review board-approved, Food and Drug Administration-approved, remote, Web-based data collection systems. Computerized automation minimizes cost and minimizes surgeon time demand. A research registry can be a powerful tool to observe and understand variations in treatment and outcomes, to examine factors that influence prognosis and quality of life, to describe care patterns, to assess effectiveness, to monitor safety, and to change provider practice through feedback of data. Registry of validated, prospective outcome data is required for arthroscopic and related researchers and the public to advocate with governments and health payers. The goal is to develop evidence-based data to determine the best methods for treating patients. Copyright © 2012 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

  10. Prospective Validation of a High Dimensional Shape Model for Organ Motion in Intact Cervical Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Williamson, Casey W.; Green, Garrett; Noticewala, Sonal S.; Li, Nan; Shen, Hanjie [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States); Vaida, Florin [Division of Biostatistics and Bioinformatics, Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, California (United States); Mell, Loren K., E-mail: lmell@ucsd.edu [Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California (United States)

    2016-11-15

    Purpose: Validated models are needed to justify strategies to define planning target volumes (PTVs) for intact cervical cancer used in clinical practice. Our objective was to independently validate a previously published shape model, using data collected prospectively from clinical trials. Methods and Materials: We analyzed 42 patients with intact cervical cancer treated with daily fractionated pelvic intensity modulated radiation therapy and concurrent chemotherapy in one of 2 prospective clinical trials. We collected online cone beam computed tomography (CBCT) scans before each fraction. Clinical target volume (CTV) structures from the planning computed tomography scan were cast onto each CBCT scan after rigid registration and manually redrawn to account for organ motion and deformation. We applied the 95% isodose cloud from the planning computed tomography scan to each CBCT scan and computed any CTV outside the 95% isodose cloud. The primary aim was to determine the proportion of CTVs that were encompassed within the 95% isodose volume. A 1-sample t test was used to test the hypothesis that the probability of complete coverage was different from 95%. We used mixed-effects logistic regression to assess effects of time and patient variability. Results: The 95% isodose line completely encompassed 92.3% of all CTVs (95% confidence interval, 88.3%-96.4%), not significantly different from the 95% probability anticipated a priori (P=.19). The overall proportion of missed CTVs was small: the grand mean of covered CTVs was 99.9%, and 95.2% of misses were located in the anterior body of the uterus. Time did not affect coverage probability (P=.71). Conclusions: With the clinical implementation of a previously proposed PTV definition strategy based on a shape model for intact cervical cancer, the probability of CTV coverage was high and the volume of CTV missed was low. This PTV expansion strategy is acceptable for clinical trials and practice; however, we recommend daily

  11. Medical students' experiences of their own professional development during three clinical terms: a prospective follow-up study.

    Science.gov (United States)

    Kalén, Susanne; Lachmann, Hanna; Varttinen, Maria; Möller, Riitta; Bexelius, Tomas S; Ponzer, Sari

    2017-02-27

    A modern competency-based medical education is well implemented globally, but less is known about how the included learning activities contribute to medical students' professional development. The aim of this study was to explore Swedish medical students' perceptions of the offered learning activities and their experiences of how these activities were connected to their professional development as defined by the CanMEDS framework. A prospective mixed method questionnaire study during three terms (internal medicine, scientific project, and surgery) in which data were collected by using contextual activity sampling system, i.e., the students were sent a questionnaire via their mobile phones every third week. All 136 medical students in the 6th of 11 terms in the autumn of 2012 were invited to participate. Seventy-four students (54%) filled in all of the required questionnaires (4 per term) for inclusion, the total number of questionnaires being 1335. The questionnaires focused on the students' experiences of learning activities, especially in relation to the CanMEDS Roles, collaboration with others and emotions (positive, negative, optimal experiences, i.e., "flow") related to the studies. The quantitative data was analysed statistically and, for the open-ended questions, manifest inductive content analysis was used. Three of the CanMEDs Roles, Medical Expert, Scholar, and Communicator, were most frequently reported while the four others, e.g., the role Health Advocate, were less common. Collaboration with students from other professions was most usual during the 8th term. Positive emotions and experience of "flow" were most often reported during clinical learning activities while the scientific project term was connected with more negative emotions. Our results showed that it is possible, even during clinical courses, to visualise the different areas of professional competence defined in the curriculum and connect these competences to the actual learning activities

  12. Examining the Image of Prospective Teachers towards Mathematicians

    Science.gov (United States)

    Yazlik, Derya Ozlem; Erdogan, Ahmet

    2018-01-01

    The aim of this study is to identify how prospective teachers see mathematicians by the pictures they visualized. In accordance with this purpose phenomenology pattern which is one of the qualitative patterns was used. The study was carried out with 160 volunteered prospective teachers. The data collection tool to be used in this study consists of…

  13. Posterior lumbar interbody fusion using nonresorbable poly-ether-ether-ketone versus resorbable poly-L-lactide-co-D,L-lactide fusion devices: a prospective, randomized study to assess fusion and clinical outcome

    NARCIS (Netherlands)

    Jiya, T.U.; Smit, T.H.; Deddens, J.; Mullender, M.G.

    2009-01-01

    STUDY DESIGN: A prospective randomized clinical study. OBJECTIVE.: To assess fusion, clinical outcome, and complications. SUMMARY OF BACKGROUND DATA: Resorbable poly-L- lactide-co-D,L-lactide (PLDLLA) cages intended to aid spinal interbody fusion have been introduced into clinical practice within

  14. Persistent fatigue in young athletes: measuring the clinical course and identifying variables affecting clinical recovery.

    Science.gov (United States)

    Locke, S; Osborne, M; O'Rourke, P

    2011-02-01

    The objective of this paper is to measure the clinical course (months) in young athletes with persistent fatigue and to identify any covariates affecting the duration of recovery. This was a prospective longitudinal study of 68 athletes; 87% were elite (42 males, 26 females), aged 20.5±3.74 years (SD), who presented with the symptom of persistent fatigue. The collective duration to full clinical recovery was estimated using Kaplan-Meier product-limit curves, and covariates associated with prolonging recovery were identified from Cox proportional hazard models. The median recovery was 5 months (range 1-60 months). The range of presenting symptom duration was 0.5-36 months. The covariates identified were an increased duration of presenting symptoms [hazard ratio (HR), 1.06; 95% confidence interval (CI), 1.02-1.12; P=0.005] and the response of serum cortisol concentration to a standard exercise challenge (HR, 1.92; 95% CI, 1.09-3.38; P=0.03). Delay in recovery was not associated with categories of fatigue that included medical, training-related diagnoses, or other causes. In conclusion, the fatigued athlete represents a significant clinical problem with a median recovery of 5 months, whose collective clinical course to recovery can be estimated by Kaplan-Meier curves and appears to be a continuum. © 2009 John Wiley & Sons A/S.

  15. Clinical neurophysiology referral patterns to a tertiary hospital--a prospective audit.

    LENUS (Irish Health Repository)

    Renganathan, R

    2012-02-03

    BACKGROUND: Cork University Hospital (CUH) provides a tertiary service for all neurophysiology referrals in the Southern Health Board region. AIM: To ascertain the number, source, symptoms and diagnosis of neurophysiology referrals at CUH. METHODS: We did a prospective audit of the referral patterns to the neurophysiology department over a 12 -week period. RESULTS: Of 635 referrals, 254 had electromyograms (EMG), 359 had electro-encephalograms (EEG), 18 had visual evoked potentials (VEP), three had somato-sensory evoked potentials (SSEP) and one had multiple sleep latency tests (MSLT). We analysed the demographic pattern, reason for referrals, the average waiting time for neurophysiology tests and the patterns of diagnosis in this audit. CONCLUSIONS: Patients from County Cork are making more use of the neurophysiology services than patients from other counties within the Southern Health Board. The average waiting time for an EEG was 32 days and for an EMG was 74 days. However, more than 35% of those patients waiting for an EEG or an EMG had their tests done within four weeks of referral. The appointments of EEG and EMG were assigned on the basis of clinical need.

  16. Translating ocular biomechanics into clinical practice: current state and future prospects.

    Science.gov (United States)

    Girard, Michaël J A; Dupps, William J; Baskaran, Mani; Scarcelli, Giuliano; Yun, Seok H; Quigley, Harry A; Sigal, Ian A; Strouthidis, Nicholas G

    2015-01-01

    Biomechanics is the study of the relationship between forces and function in living organisms and is thought to play a critical role in a significant number of ophthalmic disorders. This is not surprising, as the eye is a pressure vessel that requires a delicate balance of forces to maintain its homeostasis. Over the past few decades, basic science research in ophthalmology mostly confirmed that ocular biomechanics could explain in part the mechanisms involved in almost all major ophthalmic disorders such as optic nerve head neuropathies, angle closure, ametropia, presbyopia, cataract, corneal pathologies, retinal detachment and macular degeneration. Translational biomechanics in ophthalmology, however, is still in its infancy. It is believed that its use could make significant advances in diagnosis and treatment. Several translational biomechanics strategies are already emerging, such as corneal stiffening for the treatment of keratoconus, and more are likely to follow. This review aims to cultivate the idea that biomechanics plays a major role in ophthalmology and that the clinical translation, lead by collaborative teams of clinicians and biomedical engineers, will benefit our patients. Specifically, recent advances and future prospects in corneal, iris, trabecular meshwork, crystalline lens, scleral and lamina cribrosa biomechanics are discussed.

  17. A prospective echocardiographic evaluation of pulmonary hypertension in chronic hemodialysis patients in the United States: prevalence and clinical significance

    Directory of Open Access Journals (Sweden)

    Kumudha Ramasubbu

    2010-09-01

    Full Text Available Kumudha Ramasubbu1, Anita Deswal1, Cheryl Herdejurgen2, David Aguilar1, Adaani E Frost21Section of Cardiology, Michael E DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas, USA; 2Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, Texas, USABackground: Pulmonary hypertension (PH, a disease which carries substantial morbidity and mortality, has been reported to occur in 25%–45% of dialysis patients. No prospective evaluation of the prevalence or clinical significance of PH in chronic dialysis patients in the United States (US has been undertaken.Methods: Echocardiograms were performed prospectively in chronic hemodialysis patients prior to dialysis at a single dialysis center. PH was defined as a tricuspid regurgitant jet ≥2.5 m/s and “more severe PH” as ≥3.0 m/s. Clinical outcomes recovered were all-cause hospitalizations and death at 12 months.Results: In a cohort of 90 patients, 42 patients (47% met the definition of PH. Of those, 18 patients (20% met the definition of more severe PH. At 12 months, mortality was significantly higher in patients with PH (26% compared with patients without PH (6%. All-cause hospitalizations were similar in patients with PH and without PH. Echocardiographic findings suggesting impaired left ventricular function and elevated pulmonary capillary wedge pressure were significantly associated with PH.Conclusion: This prospective cross-sectional study of a single dialysis unit suggests that PH may be present in nearly half of US dialysis patients and when present is associated with increased mortality. Echocardiographic findings demonstrate an association between elevated filling pressures, elevated pulmonary artery pressures, and higher mortality, suggesting that the PH may be secondary to diastolic dysfunction and compounded by volume overload.Keywords: renal failure, pulmonary hypertension, diastolic dysfunction

  18. Effect of blood collection technique in mice on clinical pathology parameters.

    Science.gov (United States)

    Schnell, Michael A; Hardy, Christine; Hawley, Melanie; Propert, Kathleen Joy; Wilson, James M

    2002-01-01

    A study was conducted in normal healthy C57BL/6 mice to determine the effect of method of blood collection on clinical pathology parameters and to provide value ranges for these parameters. Males and females were used and were randomly assigned to treatment groups based upon phlebotomy method. The blood was collected using one of four methods: intracardiac (IC), a single attempt at collection from the caudal vena cava (VC), collection from the caudal vena cava with collection of any extravasated blood from the peritoneum (MC), or retroorbital phlebotomy (RO). Evaluation of blood and serum samples was conducted for a number of serum biochemistries including liver function tests and complete blood count with differentials and platelet counts. Female mice demonstrated higher values for red blood cell number, hemoglobin (p values for platelet counts, specific white blood cell numbers (total, neutrophil, lymphocyte, and eosinophil counts), globulin, amylase, and the BUN/creatinine ratio. Overall, the VC method was associated with the least variation in both sexes and appeared slightly better than the IC method for the parameters evaluated. The largest difference between groups was noted for the transaminase levels. While alanine aminotransferase (ALT) values were similar between the IC and VC groups, aspartate aminotransferase (AST) values were associated with less variation for the VC method. Transaminase levels for the MC and RO groups were associated with relatively large ranges and variation. ALT results from the RO method, the only method amenable to repetitive sample collection used in this evaluation, indicate that this is an acceptable method. The results demonstrate the substantial impact that phlebotomy method has on the assay results and that the VC or IC methods provide the most consistent results. The ranges by collection method and sex provided here can be used to select the preferred method of collection when designing a study and for comparison of data

  19. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Lindsay S Elliott

    Full Text Available In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients.This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110 were randomized to pharmacogenetic profiling (n = 57. The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53 received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR, 0.65; 95% confidence interval (CI, 0.32-1.28; P = 0.21 and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27-0.82; P = 0.007. The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31-1.21; P = 0.16 and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34-0.99; P = 0.045. Differences in composite outcomes at 60 days (exploratory endpoints

  20. Ocular Manifestations of Noonan Syndrome: A Prospective Clinical and Genetic Study of 25 Patients.

    Science.gov (United States)

    van Trier, Dorothée C; Vos, Anna M C; Draaijer, Renske W; van der Burgt, Ineke; Draaisma, Jos M Th; Cruysberg, Johannes R M

    2016-10-01

    To determine the full spectrum of ocular manifestations in patients with Noonan syndrome (NS). Prospective cross-sectional clinical and genetic study in a tertiary referral center. Twenty-five patients with NS (mean age, 14 years; range, 8 months-25 years) clinically diagnosed by validated criteria. All patients were examined by the same team following a detailed study protocol. Genetic analyses were performed in 23 patients. Ocular abnormalities of vision and refraction, external ocular features, ocular position and motility, anterior segment, posterior segment, and intraocular pressure. Ocular features of vision and refraction were amblyopia (32%), myopia (40%), and astigmatism (52%). External ocular features were epicanthic folds (84%), hypertelorism (68%), ptosis (56%), high upper eyelid crease (64%), lower eyelid retraction (60%), abnormal upward slanting palpebral fissures (36%), downward slanting palpebral fissures (32%), and lagophthalmos (28%). Orthoptic abnormalities included strabismus (40%), abnormal stereopsis (44%), and limited ocular motility (40%). Anterior segment abnormalities included prominent corneal nerves (72%) and posterior embryotoxon (32%). Additional ocular features were found, including nonglaucomatous optic disc excavation (20%), relatively low (Noonan syndrome is a clinical diagnosis with multiple genetic bases associated with an extensive variety of congenital ocular abnormalities. Ocular features of NS are characterized by 1 or more developmental anomalies of the eyelids (involving the position, opening, and closure) associated with various other ocular abnormalities in childhood, including amblyopia, myopia, astigmatism, strabismus, limited ocular motility, prominent corneal nerves, and posterior embryotoxon. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

  1. 77 FR 38634 - Request for Information: Collection and Use of Patient Work Information in the Clinical Setting...

    Science.gov (United States)

    2012-06-28

    ... (specialty) health care: At your clinical facility, how is the patient's work information collected... the Clinical Setting: Electronic Health Records AGENCY: The National Institute for Occupational Safety... Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of...

  2. Steps towards single source--collecting data about quality of life within clinical information systems.

    Science.gov (United States)

    Fritz, Fleur; Ständer, Sonja; Breil, Bernhard; Dugas, Martin

    2010-01-01

    Information about the quality of life from patients being treated in routine medical care is important for the attending physician. This data is also needed in research for example to evaluate the therapy and the course of the disease respectively. Especially skin diseases often negatively affect the quality of life. Therefore we aimed to design a concept to collect such data during treatment and use it for both medical care and research in the setting of dermatology. We performed a workflow analysis and implemented a designated form using the tools of the local clinical information system. Quality of life data is now collected within the clinical information system during treatment and is used for discharge letters, progress overviews as well as research about the treatment and course of disease. This concept which contributes to the single source approach was feasible within dermatology and is ready to be expanded into other domains.

  3. Clinical and ultrasonographic features associated to response to intraarticular corticosteroid injection. A one year follow up prospective cohort study in knee osteoarthritis patient with joint effusion.

    Science.gov (United States)

    Calvet, Joan; Orellana, Cristóbal; Galisteo, Carlos; García-Manrique, María; Navarro, Noemí; Caixàs, Assumpta; Larrosa, Marta; Gratacós, Jordi

    2018-01-01

    Intraarticular injection is used for pain relief in knee osteoarthritis (OA), but there is not a well defined profile of patient who could get more benefit from it. The purpose of this study was to evaluate the frequency of pain relief at one year after corticosteroids intraarticular injection and to identify clinical factors associated to response in patients with knee osteoarthritis with joint effusion. One-year prospective cohort study of patients with knee OA with joint effusion confirmed by ultrasound. An intraarticular injection was performed following a clinical protocol. Anthropometric measurements, laboratory parameters, clinical severity, ultrasound parameters and radiological severity were collected. Response regarding pain and presence of synovial fluid on ultrasound at one month and at one year were evaluated. Clinical responder were consider in subjects with enough improvement to carry out normal daily activities with pain VAS<40mm. One hundred and thirty-two patients were included.A significant number of patients (61.4%) improved pain at one year following the protocol established in this study. Pain and ultrasound synovial fluid at one month appeared to predict the response at one year. The Lequesne index and the percentage of body fat were independently associated to pain at one year while the Lequesne index and ultrasound synovial hypertrophy were independently related to the presence of synovial fluid at one year. The status regarding pain or ultrasound synovial fluid at one month after an intraarticular joint injection appeared to predict the status at one year in patients with knee osteoarthritis and synovial effusion.

  4. Real-Time Data Collection Using Text Messaging in a Primary Care Clinic.

    Science.gov (United States)

    Rai, Manisha; Moniz, Michelle H; Blaszczak, Julie; Richardson, Caroline R; Chang, Tammy

    2017-12-01

    The use of text messaging is nearly ubiquitous and represents a promising method of collecting data from diverse populations. The purpose of this study was to assess the feasibility and acceptability of text message surveys in a clinical setting and to describe key lessons to minimize attrition. We obtained a convenience sample of individuals who entered the waiting room of a low-income, primary care clinic. Participants were asked to answer between 17 and 30 survey questions on a variety of health-related topics, including both open- and closed-ended questions. Descriptive statistics were used to characterize the participants and determine the response rates. Bivariate analyses were used to identify predictors of incomplete surveys. Our convenience sample consisted of 461 individuals. Of those who attempted the survey, 80% (370/461) completed it in full. The mean age of respondents was 35.4 years (standard deviation = 12.4). Respondents were predominantly non-Hispanic black (42%) or non-Hispanic white (41%), female (75%), and with at least some college education (70%). Of those who completed the survey, 84% (312/370) reported willingness to do another text message survey. Those with incomplete surveys answered a median of nine questions before stopping. Smartphone users were less likely to leave the survey incomplete compared with non-smartphone users (p = 0.004). Text-message surveys are a feasible and acceptable method to collect real-time data among low-income, clinic-based populations. Offering participants a setting for immediate survey completion, minimizing survey length, simplifying questions, and allowing "free text" responses for all questions may optimize response rates.

  5. Hepatic lipidosis: Clinical review drawn from collective effort.

    Science.gov (United States)

    Webb, Craig B

    2018-03-01

    Practical relevance: Hepatic lipidosis (HL) is the most common form of liver dysfunction in cats. If recognized early and treated appropriately, the prognosis is good; if not, the prognosis is grave. Clinical challenges: Distinguishing HL as idiopathic or secondary is critical since the presence of a concurrent disease affects the therapeutic plan and the prognosis. Despite the unique and severe nature of a cat's response to anorexia and the complexity of the metabolic changes underlying this condition, the clinical acumen and technical ability to effectively diagnose and treat HL are readily available to all small animal practitioners. Patient group: Although many species develop a 'fatty liver', the cat is one of relatively few species that suffer from HL. The classic presentation is that of an overweight cat that stops eating for days to weeks, losing weight in the process. Equipment: Abdominal ultrasound is frequently employed in the diagnostic work-up of an anorectic cat; ultrasonographic findings often support a presumptive diagnosis, provide samples for cytology and, perhaps most importantly, help identify concurrent conditions that must be addressed for therapeutic success. All of the equipment necessary for essential nutritional intervention in an anorectic cat is readily available and easily affordable. Evidence base: The material for this review draws heavily on a relatively large number of original studies, excellent reviews by recognized experts, and informative communication with experienced clinicians, hence the term 'collective effort'.

  6. Prospective Memory in Context: Moving through a Familiar Space

    Science.gov (United States)

    Smith, Rebekah E.; Hunt, R. Reed; Murray, Amy E.

    2017-01-01

    Successful completion of delayed intentions is a common but important aspect of daily behavior. Such behavior requires not only memory for the intended action but also recognition of the opportunity to perform that action, known collectively as prospective memory. The fact that prospective memory tasks occur in the midst of other activities is…

  7. Fully Automated Simultaneous Integrated Boosted-Intensity Modulated Radiation Therapy Treatment Planning Is Feasible for Head-and-Neck Cancer: A Prospective Clinical Study

    Energy Technology Data Exchange (ETDEWEB)

    Wu Binbin, E-mail: binbin.wu@gunet.georgetown.edu [Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins University, Baltimore, Maryland (United States); Department of Radiation Medicine, Georgetown University Hospital, Washington, DC (United States); McNutt, Todd [Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins University, Baltimore, Maryland (United States); Zahurak, Marianna [Department of Oncology Biostatistics, Johns Hopkins University, Baltimore, Maryland (United States); Simari, Patricio [Autodesk Research, Toronto, ON (Canada); Pang, Dalong [Department of Radiation Medicine, Georgetown University Hospital, Washington, DC (United States); Taylor, Russell [Department of Computer Science, Johns Hopkins University, Baltimore, Maryland (United States); Sanguineti, Giuseppe [Department of Radiation Oncology and Molecular Radiation Science, Johns Hopkins University, Baltimore, Maryland (United States)

    2012-12-01

    Purpose: To prospectively determine whether overlap volume histogram (OVH)-driven, automated simultaneous integrated boosted (SIB)-intensity-modulated radiation therapy (IMRT) treatment planning for head-and-neck cancer can be implemented in clinics. Methods and Materials: A prospective study was designed to compare fully automated plans (APs) created by an OVH-driven, automated planning application with clinical plans (CPs) created by dosimetrists in a 3-dose-level (70 Gy, 63 Gy, and 58.1 Gy), head-and-neck SIB-IMRT planning. Because primary organ sparing (cord, brain, brainstem, mandible, and optic nerve/chiasm) always received the highest priority in clinical planning, the study aimed to show the noninferiority of APs with respect to PTV coverage and secondary organ sparing (parotid, brachial plexus, esophagus, larynx, inner ear, and oral mucosa). The sample size was determined a priori by a superiority hypothesis test that had 85% power to detect a 4% dose decrease in secondary organ sparing with a 2-sided alpha level of 0.05. A generalized estimating equation (GEE) regression model was used for statistical comparison. Results: Forty consecutive patients were accrued from July to December 2010. GEE analysis indicated that in APs, overall average dose to the secondary organs was reduced by 1.16 (95% CI = 0.09-2.33) with P=.04, overall average PTV coverage was increased by 0.26% (95% CI = 0.06-0.47) with P=.02 and overall average dose to the primary organs was reduced by 1.14 Gy (95% CI = 0.45-1.8) with P=.004. A physician determined that all APs could be delivered to patients, and APs were clinically superior in 27 of 40 cases. Conclusions: The application can be implemented in clinics as a fast, reliable, and consistent way of generating plans that need only minor adjustments to meet specific clinical needs.

  8. Fully Automated Simultaneous Integrated Boosted–Intensity Modulated Radiation Therapy Treatment Planning Is Feasible for Head-and-Neck Cancer: A Prospective Clinical Study

    International Nuclear Information System (INIS)

    Wu Binbin; McNutt, Todd; Zahurak, Marianna; Simari, Patricio; Pang, Dalong; Taylor, Russell; Sanguineti, Giuseppe

    2012-01-01

    Purpose: To prospectively determine whether overlap volume histogram (OVH)–driven, automated simultaneous integrated boosted (SIB)-intensity-modulated radiation therapy (IMRT) treatment planning for head-and-neck cancer can be implemented in clinics. Methods and Materials: A prospective study was designed to compare fully automated plans (APs) created by an OVH-driven, automated planning application with clinical plans (CPs) created by dosimetrists in a 3-dose-level (70 Gy, 63 Gy, and 58.1 Gy), head-and-neck SIB-IMRT planning. Because primary organ sparing (cord, brain, brainstem, mandible, and optic nerve/chiasm) always received the highest priority in clinical planning, the study aimed to show the noninferiority of APs with respect to PTV coverage and secondary organ sparing (parotid, brachial plexus, esophagus, larynx, inner ear, and oral mucosa). The sample size was determined a priori by a superiority hypothesis test that had 85% power to detect a 4% dose decrease in secondary organ sparing with a 2-sided alpha level of 0.05. A generalized estimating equation (GEE) regression model was used for statistical comparison. Results: Forty consecutive patients were accrued from July to December 2010. GEE analysis indicated that in APs, overall average dose to the secondary organs was reduced by 1.16 (95% CI = 0.09-2.33) with P=.04, overall average PTV coverage was increased by 0.26% (95% CI = 0.06-0.47) with P=.02 and overall average dose to the primary organs was reduced by 1.14 Gy (95% CI = 0.45-1.8) with P=.004. A physician determined that all APs could be delivered to patients, and APs were clinically superior in 27 of 40 cases. Conclusions: The application can be implemented in clinics as a fast, reliable, and consistent way of generating plans that need only minor adjustments to meet specific clinical needs.

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

    LENUS (Irish Health Repository)

    Markey, G C

    2010-06-24

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

  10. Collecting data in real time with postcards

    DEFF Research Database (Denmark)

    Yee, Kwang Chien; Kanstrup, Anne Marie; Bertelsen, Pernille

    2013-01-01

    Systems. These methods often involve cross-sectional, retrospective data collection. This paper describes the postcard method for prospective real-time data collection, both in paper format and electronic format. This paper then describes the results obtained using postcard techniques in Denmark...

  11. Distinguishing infected from noninfected abdominal fluid collections after surgery: an imaging, clinical, and laboratory-based scoring system.

    Science.gov (United States)

    Gnannt, Ralph; Fischer, Michael A; Baechler, Thomas; Clavien, Pierre-Alain; Karlo, Christoph; Seifert, Burkhardt; Lesurtel, Mickael; Alkadhi, Hatem

    2015-01-01

    Mortality from abdominal abscesses ranges from 30% in treated cases up to 80% to 100% in patients with undrained or nonoperated abscesses. Various computed tomographic (CT) imaging features have been suggested to indicate infection of postoperative abdominal fluid collections; however, features are nonspecific and substantial overlap between infected and noninfected collections exists. The purpose of this study was to develop and validate a scoring system on the basis of CT imaging findings as well as laboratory and clinical parameters for distinguishing infected from noninfected abdominal fluid collections after surgery. The score developmental cohort included 100 consecutive patients (69 men, 31 women; mean age, 58 ± 17 years) who underwent portal-venous phase CT within 24 hours before CT-guided intervention of postoperative abdominal fluid collections. Imaging features included attenuation (Hounsfield unit [HU]), volume, wall enhancement and thickness, fat stranding, as well as entrapped gas of fluid collections. Laboratory and clinical parameters included diabetes, intake of immunosuppressive drugs, body temperature, C-reactive protein, and leukocyte blood cell count. The score was validated in a separate cohort of 30 consecutive patients (17 men, 13 women; mean age, 51 ± 15 years) with postoperative abdominal fluid collections. Microbiologic analysis from fluid samples served as the standard of reference. Diabetes, body temperature, C-reactive protein, attenuation of the fluid collection (in HUs), wall enhancement and thickness of the wall, adjacent fat stranding, as well as entrapped gas within the fluid collection were significantly different between infected and noninfected collections (P collection (in HUs), as well as entrapped gas as significant independent predictors of infection (P collection, ≥ 20 HU: 4 points; entrapped gas: 3 points). The model was well calibrated (Hosmer-Lemeshow test, P = 0.36). In the validation cohort, scores of 2 or lower

  12. Is it possible to strengthen psychiatric nursing staff's clinical supervision?

    DEFF Research Database (Denmark)

    Gonge, Henrik; Buus, Niels

    2015-01-01

    AIM: To test the effects of a meta-supervision intervention in terms of participation, effectiveness and benefits of clinical supervision of psychiatric nursing staff. BACKGROUND: Clinical supervision is regarded as a central component in developing mental health nursing practices, but the evidence...... an intervention group (n = 40) receiving the meta-supervision in addition to attending usual supervision or to a control group (n = 43) attending usual supervision. METHODS: Self-reported questionnaire measures of clinical supervision effectiveness and benefits were collected at base line in January 2012...... and at follow-up completed in February 2013. In addition, a prospective registration of clinical supervision participation was carried out over 3 months subsequent to the intervention. RESULTS: The main result was that it was possible to motivate staff in the intervention group to participate significantly more...

  13. Toward Fully Automated Multicriterial Plan Generation: A Prospective Clinical Study

    International Nuclear Information System (INIS)

    Voet, Peter W.J.; Dirkx, Maarten L.P.; Breedveld, Sebastiaan; Fransen, Dennie; Levendag, Peter C.; Heijmen, Ben J.M.

    2013-01-01

    Purpose: To prospectively compare plans generated with iCycle, an in-house-developed algorithm for fully automated multicriterial intensity modulated radiation therapy (IMRT) beam profile and beam orientation optimization, with plans manually generated by dosimetrists using the clinical treatment planning system. Methods and Materials: For 20 randomly selected head-and-neck cancer patients with various tumor locations (of whom 13 received sequential boost treatments), we offered the treating physician the choice between an automatically generated iCycle plan and a manually optimized plan using standard clinical procedures. Although iCycle used a fixed “wish list” with hard constraints and prioritized objectives, the dosimetrists manually selected the beam configuration and fine tuned the constraints and objectives for each IMRT plan. Dosimetrists were not informed in advance whether a competing iCycle plan was made. The 2 plans were simultaneously presented to the physician, who then selected the plan to be used for treatment. For the patient group, differences in planning target volume coverage and sparing of critical tissues were quantified. Results: In 32 of 33 plan comparisons, the physician selected the iCycle plan for treatment. This highly consistent preference for the automatically generated plans was mainly caused by the improved sparing for the large majority of critical structures. With iCycle, the normal tissue complication probabilities for the parotid and submandibular glands were reduced by 2.4% ± 4.9% (maximum, 18.5%, P=.001) and 6.5% ± 8.3% (maximum, 27%, P=.005), respectively. The reduction in the mean oral cavity dose was 2.8 ± 2.8 Gy (maximum, 8.1 Gy, P=.005). For the swallowing muscles, the esophagus and larynx, the mean dose reduction was 3.3 ± 1.1 Gy (maximum, 9.2 Gy, P<.001). For 15 of the 20 patients, target coverage was also improved. Conclusions: In 97% of cases, automatically generated plans were selected for treatment because of

  14. Real-world Data for Clinical Evidence Generation in Oncology.

    Science.gov (United States)

    Khozin, Sean; Blumenthal, Gideon M; Pazdur, Richard

    2017-11-01

    Conventional cancer clinical trials can be slow and costly, often produce results with limited external validity, and are difficult for patients to participate in. Recent technological advances and a dynamic policy landscape in the United States have created a fertile ground for the use of real-world data (RWD) to improve current methods of clinical evidence generation. Sources of RWD include electronic health records, insurance claims, patient registries, and digital health solutions outside of conventional clinical trials. A definition focused on the original intent of data collected at the point of care can distinguish RWD from conventional clinical trial data. When the intent of data collection at the point of care is research, RWD can be generated using experimental designs similar to those employed in conventional clinical trials, but with several advantages that include gains in efficient execution of studies with an appropriate balance between internal and external validity. RWD can support active pharmacovigilance, insights into the natural history of disease, and the development of external control arms. Prospective collection of RWD can enable evidence generation based on pragmatic clinical trials (PCTs) that support randomized study designs and expand clinical research to the point of care. PCTs may help address the growing demands for access to experimental therapies while increasing patient participation in cancer clinical trials. Conducting valid real-world studies requires data quality assurance through auditable data abstraction methods and new incentives to drive electronic capture of clinically relevant data at the point of care. Published by Oxford University Press 2017. This work is written by US Government employees and is in the public domain in the US.

  15. Prospective SAH Study in Japan, 2005(Prospective SAH Study)

    OpenAIRE

    塩川, 芳昭; 栗田, 浩樹; 藤井, 清孝; Yoshiaki, SHIOKAWA; Hiroki, KURITA; Kiyotaka, FUJII; 杏林大学脳神経外科; 杏林大学脳神経外科; 北里大学脳神経外科; Department of Neurosurgery, Kyorin University School of Medicine; Department of Neurosurgery, Kyorin University School of Medicine

    2009-01-01

    To clarify current treatment status of ruptured cerebral aneurysms in Japan, a prospective multicenter observational study on the treatment results for aneurysmal subarachnoid hemorrhage was conducted over calendar year 2005 and final 1-year outcomes were collected. Studied centers were selected from among institutes of committee member of Japanese stroke surgery organization or symposium of vasospasm in Japan. A total of 927 patients were enrolled in this study and treatment policies were le...

  16. The Clinical Assessment Study of the Hand (CAS-HA: a prospective study of musculoskeletal hand problems in the general population

    Directory of Open Access Journals (Sweden)

    Marshall Michelle

    2007-08-01

    Full Text Available Abstract Background Pain in the hand affects an estimated 12–21% of the population, and at older ages the hand is one of the most common sites of pain and osteoarthritis. The association between symptomatic hand osteoarthritis and disability in everyday life has not been studied in detail, although there is evidence that older people with hand problems suffer significant pain and disability. Despite the high prevalence of hand problems and the limitations they cause in older adults, little attention has been paid to the hand by health planners and policy makers. We plan to conduct a prospective, population-based, observational cohort study designed in parallel with our previously reported cohort study of knee pain, to describe the course of musculoskeletal hand problems in older adults and investigate the relative merits of different approaches to classification and defining prognosis. Methods/Design All adults aged 50 years and over registered with two general practices in North Staffordshire will be invited to take part in a two-stage postal survey. Respondents to the survey who indicate that they have experienced hand pain or problems within the previous 12 months will be invited to attend a research clinic for a detailed assessment. This will consist of clinical interview, hand assessment, screening test of lower limb function, digital photography, plain x-rays, anthropometric measurement and brief self-complete questionnaire. All consenting clinic attenders will be followed up by (i general practice medical record review, (ii repeat postal questionnaire at 18-months, and (iii repeat postal questionnaire at 3 years. Discussion This paper describes the protocol for the Clinical Assessment Study of the Hand (CAS-HA, a prospective, population-based, observational cohort study of community-dwelling older adults with hand pain and hand problems based in North Staffordshire.

  17. A process-model based approach to prospective memory impairment in Parkinson's disease.

    Science.gov (United States)

    Kliegel, Matthias; Altgassen, Mareike; Hering, Alexandra; Rose, Nathan S

    2011-07-01

    The present review discusses the current state of research on the clinical neuropsychology of prospective memory in Parkinson's disease. To do so the paper is divided in two sections. In the first section, we briefly outline key features of the (partly implicit) rationale underlying the available literature on the clinical neuropsychology of prospective memory. Here, we present a conceptual model that guides our approach to the clinical neuropsychology of prospective memory in general and to the effects of Parkinson's disease on prospective memory in particular. In the second section, we use this model to guide our review of the available literature and suggest some open issues and future directions motivated by previous findings and the proposed conceptual model. The review suggests that certain phases of the prospective memory process (intention formation und initiation) are particularly impaired by Parkinson's disease. In addition, it is argued that prospective memory may be preserved when tasks involve specific features (e.g., focal cues) that reduce the need for strategic monitoring processes. In terms of suggestions for future directions, it is noted that intervention studies are needed which target the specific phases of the prospective memory process that are impaired in Parkinson's disease, such as planning interventions. Moreover, it is proposed that prospective memory deficits in Parkinson's disease should be explored in the context of a general impairment in the ability to form an intention and plan or coordinate an appropriate series of actions. Copyright © 2011 Elsevier Ltd. All rights reserved.

  18. Early detection of clinically significant prostate cancer at diagnosis: a prospective study using a novel panel of TMPRSS2:ETS fusion gene markers

    International Nuclear Information System (INIS)

    Chan, Sam W.; Nguyen, Phuong-Nam; Violette, Philippe; Brimo, Fadi; Taguchi, Yosh; Aprikian, Armen; Chen, Junjian Z.

    2013-01-01

    We explore noninvasive clinical applications of multiple disease-specific fusion markers recently discovered in prostate cancer to predict the risk of cancer occurrence and aggressiveness at diagnosis. A total of 92 men who were prostate-specific antigen (PSA) screened and scheduled for diagnostic biopsy were enrolled for this study. Prospectively collected urine was blind coded for laboratory tests. RNA from urine sediments was analyzed using a panel of 6 TMPRSS2:ETS fusion markers with a sensitive quantitative PCR platform. The pathology reported 39 biopsy-positive cases from 92 patients (42.4%). In urine test, 10 unique combinations of fusion types were detected in 32 of 92 (34.8%) prebiopsy samples. A novel combination of fusion markers, termed Fx (III, IV, ETS), was identified with a sensitivity of 51.3% and an odds ratio of 10.1 in detecting cancer on biopsy. Incorporating a categorical variable of Fx (III, IV, ETS) with urine PCA3 and serum PSA, a regression model was developed to predict biopsy outcomes with an overall accuracy of 77%. Moreover, the overexpression of Fx (III, IV, or ETS) was shown to be an independent predictor to the high-grade cancer, with a predictive accuracy of 80% when coupled with PSA density. The individualized risk scores further stratified a high-risk group that is composed of 92% high-grade cancers and a low-risk group that harbors mainly clinically insignificant cancers. In conclusion, we have identified a novel combination of fusion types very specific to the clinically significant prostate cancer and developed effective regression models to predict biopsy outcomes and aggressive cancers at diagnosis

  19. Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry.

    Science.gov (United States)

    Stemmer, Salomon M; Steiner, Mariana; Rizel, Shulamith; Soussan-Gutman, Lior; Ben-Baruch, Noa; Bareket-Samish, Avital; Geffen, David B; Nisenbaum, Bella; Isaacs, Kevin; Fried, Georgeta; Rosengarten, Ora; Uziely, Beatrice; Svedman, Christer; McCullough, Debbie; Maddala, Tara; Klang, Shmuel H; Zidan, Jamal; Ryvo, Larisa; Kaufman, Bella; Evron, Ella; Karminsky, Natalya; Goldberg, Hadassah; Shak, Steven; Liebermann, Nicky

    2017-01-01

    The 21-gene Recurrence Score® (RS) assay is a validated prognostic/predictive tool in ER + early-stage breast cancer. However, clinical outcome data from prospective studies in RS ≥ 11 patients are lacking, as are relevant real-life clinical practice data. In this retrospective analysis of a prospectively designed registry, we evaluated treatments/clinical outcomes in patients undergoing RS-testing through Clalit Health Services. The analysis included N0 ER + HER2-negative breast cancer patients who were RS-tested from 1/2006 through 12/2010. Medical records were reviewed to verify treatments/recurrences/survival. The cohort included 1801 patients (median follow-up, 6.2 years). Median age was 60 years, 50.4% were grade 2 and 81.1% had invasive ductal carcinoma; 48.9% had RS < 18, 40.7% RS 18-30, and 10.4% RS ≥ 31, with chemotherapy use of 1.4, 23.7, and 87.2%, respectively. The 5-year Kaplan-Meier estimates for distant recurrence were 0.8, 3.0, and 8.6%, for patients with RS < 18, RS 18-30 and RS ≥ 31, respectively; the corresponding 5-year Kaplan-Meier estimates for breast cancer death were 0.0, 0.9, and 6.2%. Chemotherapy-untreated patients with RS < 11 ( n  = 304) and 11-25 ( n  = 1037) (TAILORx categorizatio n ) had 5-year Kaplan-Meier estimates for distant recurrence risk/breast cancer death of 1.0%/0.0% and 1.3%/0.4%, respectively. Our results extend those of the prospective TAILORx trial: the 5-year Kaplan-Meier estimates for distant recurrence and breast cancer death rate for the RS < 18 patients were very low supporting the use of endocrine therapy alone. Furthermore, in chemotherapy-untreated patients with RS 11-25 (where TAILORx patients were randomized to chemoendocrine or endocrine therapy alone), 5-year distant recurrence rates were also very low, suggesting that chemotherapy would not have conferred clinically meaningful benefit.

  20. Exploring nurses' perceptions of collecting and using HOBIC measures to guide clinical practice and improve care.

    Science.gov (United States)

    Jeffs, Lianne; Wilson, Gail; Ferris, Ella; Cardiff, Brenda; Ng, San; Lanceta, Mary; White, Peggy; Pringle, Dorothy

    2012-03-01

    Ontario's Health Outcomes for Better Information and Care (HOBIC) is designed to help organizations and nurses plan and evaluate care by comparing patient outcomes with historical data on similar cases. Yet, fewer than 15% of patients in a 2010 study were found to have complete admission and discharge data sets. This low utilization rate of HOBIC measures prompted the current qualitative study, in which nurses from three clinical settings in an academic teaching hospital were interviewed to gain their perceptions related to collecting and using HOBIC measures in practice. The objective was to identify factors that promote or impede the collection and use of HOBIC data in clinical practice to improve patient care and outcomes. Analysis of interview results produced four key themes related to (a) use of HOBIC measures to inform patient care, (b) collecting and documenting HOBIC measures, (c) HOBIC as an afterthought and "black hole" and (d) impediments to assessing and documenting HOBIC measures because of language barriers, patients' cognitive status and lack of time. Recommendations to improve uptake include developing, implementing and evaluating a communication and learning plan that promotes HOBIC's values and benefits, and determining how managers and administrators perceive utilization of HOBIC at the clinical unit and organizational levels.

  1. Clinical validation of a public health policy-making platform for hearing loss (EVOTION): protocol for a big data study.

    Science.gov (United States)

    Dritsakis, Giorgos; Kikidis, Dimitris; Koloutsou, Nina; Murdin, Louisa; Bibas, Athanasios; Ploumidou, Katherine; Laplante-Lévesque, Ariane; Pontoppidan, Niels Henrik; Bamiou, Doris-Eva

    2018-02-15

    The holistic management of hearing loss (HL) requires an understanding of factors that predict hearing aid (HA) use and benefit beyond the acoustics of listening environments. Although several predictors have been identified, no study has explored the role of audiological, cognitive, behavioural and physiological data nor has any study collected real-time HA data. This study will collect 'big data', including retrospective HA logging data, prospective clinical data and real-time data via smart HAs, a mobile application and biosensors. The main objective is to enable the validation of the EVOTION platform as a public health policy-making tool for HL. This will be a big data international multicentre study consisting of retrospective and prospective data collection. Existing data from approximately 35 000 HA users will be extracted from clinical repositories in the UK and Denmark. For the prospective data collection, 1260 HA candidates will be recruited across four clinics in the UK and Greece. Participants will complete a battery of audiological and other assessments (measures of patient-reported HA benefit, mood, cognition, quality of life). Patients will be offered smart HAs and a mobile phone application and a subset will also be given wearable biosensors, to enable the collection of dynamic real-life HA usage data. Big data analytics will be used to detect correlations between contextualised HA usage and effectiveness, and different factors and comorbidities affecting HL, with a view to informing public health decision-making. Ethical approval was received from the London South East Research Ethics Committee (17/LO/0789), the Hippokrateion Hospital Ethics Committee (1847) and the Athens Medical Center's Ethics Committee (KM140670). Results will be disseminated through national and international events in Greece and the UK, scientific journals, newsletters, magazines and social media. Target audiences include HA users, clinicians, policy-makers and the

  2. A prospective study of the early clinical symptoms following a 2 Gy therapeutic whole-body irradiation

    International Nuclear Information System (INIS)

    Fizazi, K.; Chaillet, M.P.; Fourquet, A.; Jammet, P.; Cosset, J.M.

    1995-01-01

    Early human tolerance following total body irradiation (TBI) according to the dose received is still poorly known. Thirteen selected patients were prospectively evaluated for clinical side effects during the first 10 hours following a 2 Gy TBI prior to bone marrow transplantation. All of them but one were treated for haematological malignancies and were in clinical remission at the date of TBI. There were 10 males and 3 females, with a median age of 43 y (range 16*61) and a good performance status (WHO 0-1). They received granisetron (3 mg) injected intravenously 1 h before the time of TBI in order to prevent nausea and vomiting. The main symptoms consisted in drowsiness (69%), headache (62%), xerostomia (62%), nausea and vomiting (46%), anorexia (38%), parotid gland pain (23%) and abdominal pain (8%). Their intensity was always moderate, except for 2 patients who experimented severe vomiting. The incidence rate and the time-course of the symptoms of the prodromal phase may proved to be helpful for early clinical evaluation and triage of victims of an accidental irradiation. In particular, absence of fever at the 6 th h after TBI supports the assumption of an estimated exposure dose below 2 Gy. (authors). 23 refs., 2 tabs

  3. Chemoprevention of Lung Cancer: Prospects and Disappointments in Human Clinical Trials

    Directory of Open Access Journals (Sweden)

    William N. Rom

    2013-01-01

    Full Text Available Decreasing the risk of lung cancer, or preventing its development in high-risk individuals, would have a huge impact on public health. The most effective means to decrease lung cancer incidence is to eliminate exposure to carcinogens. However, with recent advances in the understanding of pulmonary carcinogenesis and the identification of intermediate biomarkers, the prospects for the field of chemoprevention research have improved dramatically. Here we review the most recent research in lung cancer chemoprevention—focusing on those agents that have been investigated in human clinical trials. These agents fall into three major categories. First, oxidative stress plays an important role in pulmonary carcinogenesis; and therefore, antioxidants (including vitamins, selenium, green tea extracts, and isothiocyanates may be particularly effective in preventing the development of lung cancer. Second, inflammation is increasingly accepted as a crucial factor in carcinogenesis, and many investigators have focused on anti-inflammatory agents, such as glucocorticoids, NSAIDs, statins, and PPARγ agonists. Finally, the PI3K/AKT/mTOR pathway is recognized to play a central role in tobacco-induced carcinogenesis, and inhibitors of this pathway, including myoinositol and metformin, are promising agents for lung cancer prevention. Successful chemoprevention will likely require targeting of multiple pathways to carcinogenesis—both to minimize toxicity and maximize efficacy.

  4. Clinical application prospect of umbilical cord-derived mesenchymal stem cells on clearance of advanced glycation end products through autophagy on diabetic wound.

    Science.gov (United States)

    Han, Yanfu; Sun, Tianjun; Tao, Ran; Han, Yanqing; Liu, Jing

    2017-03-24

    Nowadays, wound healing delay due to diabetes is considered to be closely related to the accumulation of advanced glycation end products (AGEs). Although mesenchymal stem cells (MSCs) exhibit positive effects on diabetic wound healing, related mechanisms are still not fully elucidated. It has been reported that MSCs can improve the activity of autophagy in injured tissues, thereby playing an important role in wound healing. The autophagy induced by MSCs may be beneficial to diabetic wound healing via removing AGEs, which provide new ideas for clinical treatment of diabetic wounds with the potential of broad application prospects. In this study, the current research situation and application prospect of umbilical cord-derived MSCs on the clearance of AGEs in diabetic wound were reviewed.

  5. Prospective Register Of patients undergoing repeated OFfice and Ambulatory Blood Pressure Monitoring (PROOF-ABPM): protocol for an observational cohort study.

    Science.gov (United States)

    Sheppard, James P; Martin, Una; Gill, Paramjit; Stevens, Richard; McManus, Richard J

    2016-10-31

    The diagnosis and management of hypertension depends on accurate measurement of blood pressure (BP) in order to target antihypertensive treatment appropriately. Most BP measurements take place in a clinic setting, but it has long been recognised that readings taken out-of-office (via home or ambulatory monitoring) estimate true underlying BP more accurately. Recent studies have shown that the change in clinic BP over multiple readings is a significant predictor of the difference between clinic and out-of-office BP. Used in combination with patient characteristics, this change has been shown to accurately predict a patient's out-of-office BP level. The present study proposes to collect real-life BP data to prospectively validate this new prediction tool in routine clinical practice. A prospective, multicentre observational cohort design will be used, recruiting patients from primary and secondary care. All patients attending participating centres for ambulatory BP monitoring will be eligible to participate. Anonymised clinical data will be collected from all eligible patients, who will be invited to give informed consent to permit identifiable data to be collected for data linkage to external outcome registries. Descriptive statistics will be used to calculate the sensitivity, specificity, positive and negative predictive values of the out-of-office BP prediction tool. Area under the receiver operator characteristic curve statistics will be used to examine model performance. Ethical approval for this study has been obtained from the National Research. Ethics Service Committee South Central-Oxford A (reference; 15/SC/0184), and site-specific R&D approval has been acquired from the relevant NHS trusts. All findings will be presented at relevant conferences and published in peer-reviewed journals, on the study website and disseminated in lay and social media where appropriate. Published by the BMJ Publishing Group Limited. For permission to use (where not already

  6. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lee, J. Jack [Department of Biostatistics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Heymach, John V. [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Swisher, Stephen G. [Department of Surgical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Welsh, James W. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Zhang, Jianjun [Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Lin, Steven H. [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States); Gomez, Daniel R., E-mail: dgomez@mdanderson.org [Department of Radiation Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas (United States)

    2017-03-15

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  7. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

    International Nuclear Information System (INIS)

    Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

    2017-01-01

    Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.

  8. Leflunomide in active rheumatoid arthritis: A prospective study in daily practice

    NARCIS (Netherlands)

    Van Roon, E.N.; Jansen, T.L.Th.A.; Mourad, L.; Houtman, P.M.; Bruyn, G.A.W.; Griep, E.N.; Wilffert, B.; Tobi, H.; Brouwers, J.R.B.J.

    2004-01-01

    Aims: We prospectively studied the efficacy, incidence of adverse drug reactions and withdrawal from leflunomide in an outpatient population with rheumatoid arthritis in a setting of care-as-usual. Methods: In this prospective case series study, a standard dataset was collected from outpatient

  9. Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

    Science.gov (United States)

    Raunest, J; Löhnert, J

    1990-01-01

    A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

  10. Clinical Prospective Study on the Use of Subcutaneous Carboxytherapy in the Treatment of Diabetic Foot Ulcer.

    Science.gov (United States)

    Khiat, Lynda; Leibaschoff, Gustavo H

    2018-03-22

    Diabetic footfoot ulcer (DFU) is a serious complication of diabetes mellitus, and possibly the major morbidity of the diabetic foot. It is the most common foot injury in diabetic patients and can lead to lower-extremity amputation. Management of DFU requires a systematic knowledge of the major risk factors for amputation, frequent routine evaluation, scrupulous preventive maintenance, and correction of peripheral arterial insufficiency. Carboxytherapy refers to the subcutaneous injection of CO2 to improve the microcirculation and promote wound-healing by stimulating the microcirculation. Since optimal ulcer-healing requires adequate tissue perfusion, it is considered that carboxytherapy could be useful in the treatment of DFU. The present prospective clinical study included 40 patients with different sizes and types of chronic DFU. In addition to cleaning of the wound, antibiotics and debridement as necessary, the treatment protocol included blood sugar control, medication, healthy habits, no weight-bearing, and carboxytherapy. The results showed that this treatment that included carboxytherapy promoted wound-healing and prevented amputation. These positive effects should be confirmed through a complete study that includes different clinical and instrumental parameters.

  11. Incidence and predictors of hospitalization or death in patients managed in multidisciplinary heart failure clinics

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Schou, Morten; Videbaek, Lars

    2009-01-01

    AND RESULTS: A total of 4012 consecutive outpatients referred for HF management in 18 Danish HF clinics were included. Clinical data were collected prospectively. Outcome data were obtained from a validated, national registry. Mean follow-up time was 580 days. The mean age of patients was 69 years, 83% had...... creatinine 1.03 (1.02-1.04), NYHA III and IV 1.32 (1.15-1.52), and hospitalization prior to referral to the HF clinic 1.81 (1.57-2.08). CONCLUSIONS: Event rates in this cohort were lower than most published data from HF clinic populations. Factors such as advanced age, NYHA class, and prior hospitalization...... predict poor outcome in patients managed in multidisciplinary HF clinics....

  12. RNA isolation from bloodstains collected on FTA cards - application in clinical and forensic genetics.

    Science.gov (United States)

    Skonieczna, Katarzyna; Styczyński, Jan; Krenska, Anna; Wysocki, Mariusz; Jakubowska, Aneta; Grzybowski, Tomasz

    2016-01-01

    Aim of the study: In recent years, RNA analysis has been increasingly used in clinical and forensic genetics. Nevertheless, a major limitation of RNA-based applications is very low RNA stability in biological material, due to the RNAse activity. This highlights the need for improving the methods of RNA collection and storage. Technological approaches such as FTA Classic Cards (Whatman) could provide a solution for the problem of RNA degradation. However, different methods of RNA isolation from FTA cards could have diverse effects on RNA quantity and quality. The purpose of this research was to analyze the utility of three different methods of RNA isolation from peripheral blood collected on FTA Classic Cards (Whatman). The study also aimed at assessing RNA stability in bloodstains deposited on FTA cards. Material and methods: The study was performed on peripheral bloodstains collected from 59 individuals on FTA Classic Cards (Whatman). RNA was isolated with High Pure RNA Isolation Kit (Roche Diagnostics), Universal RNA/miRNA Purification (EURx) and TRIzol Reagent (Life Technologies). RNA was subjected to quantitative analysis followed by reverse transcription and Real - Time PCR reaction. Results: The study has shown that FTA Classic Cards (Whatman) are useful tools for storing bloodstains at room temperature for RNA analysis. Moreover, the method of RNA extraction employing TRIzol Reagent (Life Technologies) provides the highest efficiency and reproducibility for samples stored for no more than 2 years. Conclusions: The FTA cards are suitable for collecting and storing bloodstains for RNA analysis in clinical and forensic genetics.

  13. Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

    Science.gov (United States)

    Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

    2015-01-01

    While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

  14. Clinical Linguistics--Retrospect and Prospect.

    Science.gov (United States)

    Grunwell, Pamela

    In the past 20 years, linguistics has gained a prominent position in speech and language pathology in Britain, evolving into a new field, clinical linguistics. It includes three related areas of activity: training of speech pathologists/therapists; professional practice; and research. Linguistics and speech/language pathology have developed as…

  15. Prospective analysis of patient-reported late toxicity following pelvic radiotherapy for gynaecological cancer

    International Nuclear Information System (INIS)

    Barraclough, Lisa H.; Routledge, Jacqueline A.; Farnell, Damian J.J.; Burns, Meriel P.; Swindell, Ric; Livsey, Jacqueline E.; Davidson, Susan E.

    2012-01-01

    Background and purpose: As late radiotherapy toxicity impacts negatively on the quality-of-life of cancer survivors and is often under reported, a study was set up to prospectively collect patient-reported data in an unselected series of patients with gynaecological malignancy. Aim 1 – To provide 3 year results for the longitudinal study. Aim 2 – To improve the questionnaire used to collect data by identifying redundant items and modifying for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data. Material and methods: Aim 1 – Patient reported outcome data were collected prospectively by 226 patients before and up to 3 years following radiotherapy for gynaecological cancer using a questionnaire developed to collect LENT subjective data. Aim 2 – A factor analysis was performed to identify which questions gave the most and least information. Results: Aim 1 – Faecal urgency and incontinence (all grades) peaked at 79% and 24%, respectively at 1 year then settled to 69% and 18% at 3 years, respectively. Urinary urgency (all grades) increased with time and was described in 75% at 3 years. Other symptoms reported at 3 years include diarrhoea in 12%, urinary incontinence in 27% and vaginal dryness in 29%. A third of patients did not feel their sex life had changed following treatment, while a quarter felt that it had. Aim 2 – some questions overlapped and others were non-specific. The questionnaire has subsequently been altered. Conclusions: The extent of late toxicity is substantial. This detailed information is important for both patients and clinicians in terms of treatment decisions and follow-up care. The LENT questionnaire provides a feasible tool for capture of this information in the clinic.

  16. Neurosurgery clinical registry data collection utilizing Informatics for Integrating Biology and the Bedside and electronic health records at the University of Rochester.

    Science.gov (United States)

    Pittman, Christine A; Miranpuri, Amrendra S

    2015-12-01

    In a population health-driven health care system, data collection through the use of clinical registries is becoming imperative to continue to drive effective and efficient patient care. Clinical registries rely on a department's ability to collect high-quality and accurate data. Currently, however, data are collected manually with a high risk for error. The University of Rochester's Department of Neurosurgery in conjunction with the university's Clinical and Translational Science Institute has implemented the integrated use of the Informatics for Integrating Biology and the Bedside (i2b2) informatics framework with the Research Electronic Data Capture (REDCap) databases.

  17. Development in Children with Achondroplasia: A Prospective Clinical Cohort Study

    Science.gov (United States)

    Ireland, Penelope J.; Donaghey, Samantha; McGill, James; Zankl, Andreas; Ware, Robert S.; Pacey, Verity; Ault, Jenny; Savarirayan, Ravi; Sillence, David; Thompson, Elizabeth; Townshend, Sharron; Johnston, Leanne M.

    2012-01-01

    Aim: Achondroplasia is characterized by delays in the development of communication and motor skills. While previously reported developmental profiles exist across gross motor, fine motor, feeding, and communication skills, there has been no prospective study of development across multiple areas simultaneously. Method: This Australasian…

  18. 78 FR 27243 - Proposed Collection; 60-Day Comment Request: Interactive Informed Consent for Pediatric Clinical...

    Science.gov (United States)

    2013-05-09

    ... consent or the interactive computer-based program, will be assessed by face-to-face interview. In addition... Comment Request: Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with... other technological collection techniques or other forms of information technology. To Submit Comments...

  19. Depressive symptoms, HIV medication adherence, and HIV clinical outcomes in Tanzania: a prospective, observational study.

    Directory of Open Access Journals (Sweden)

    Nadya M Belenky

    Full Text Available Depressive symptoms have been shown to independently affect both antiretroviral therapy (ART adherence and HIV clinical outcomes in high-income countries. We examined the prospective relationship between depressive symptoms and adherence, virologic failure, and suppressed immune function in people living with HIV/AIDS in Tanzania. Data from 403 study participants who were on stable ART and engaged in HIV clinical care were analyzed. We assessed crude and adjusted associations of depressive symptoms and ART adherence, both at baseline and at 12 months, using logistic regression. We used logistic generalized estimating equations to assess the association and 95% confidence intervals (CI between depressive symptoms and both virologic failure and suppressed immune function. Ten percent of participants reported moderate or severe depressive symptoms at baseline and 31% of participants experienced virologic failure (>150 copies/ml over two years. Depressive symptoms were associated with greater odds of reported medication nonadherence at both baseline (Odds Ratio [OR] per 1-unit increase = 1.18, 95% CI [1.12, 1.24] and 12 months (OR = 1.08, 95% CI [1.03, 1.14]. By contrast, increases in depressive symptom score were inversely related to both virologic failure (OR = 0.93, 95% CI [0.87, 1.00] and immune system suppression (OR = 0.88, 95% CI [0.79, 0.99], though the association between depressive symptoms and clinical outcomes was less precise than for the association with nonadherence. Findings indicate a positive association between depressive symptoms and nonadherence, and also an inverse relationship between depressive symptoms and clinical outcomes, possibly due to informative loss to follow-up.

  20. Efficacy and Safety of the Biosimilar Infliximab CT-P13 Treatment in Inflammatory Bowel Diseases: A Prospective, Multicentre, Nationwide Cohort.

    Science.gov (United States)

    Gecse, Krisztina B; Lovász, Barbara D; Farkas, Klaudia; Banai, János; Bene, László; Gasztonyi, Beáta; Golovics, Petra Anna; Kristóf, Tünde; Lakatos, László; Csontos, Ágnes Anna; Juhász, Márk; Nagy, Ferenc; Palatka, Károly; Papp, Mária; Patai, Árpád; Lakner, Lilla; Salamon, Ágnes; Szamosi, Tamás; Szepes, Zoltán; Tóth, Gábor T; Vincze, Áron; Szalay, Balázs; Molnár, Tamás; Lakatos, Péter L

    2016-02-01

    Biosimilar infliximab CT-P13 is approved for all indications of the originator product in Europe. Prospective data on its efficacy, safety, and immunogenicity in inflammatory bowel diseases are lacking. A prospective, nationwide, multicentre, observational cohort was designed to examine the efficacy, safety, and immunogenicity of CT-P13 infliximab biosimilar in the induction treatment of Crohn's disease [CD] and ulcerative colitis [UC]. Demographic data were collected and a harmonised monitoring strategy was applied. Early clinical remission, response, and early biochemical response were evaluated at Week 14, steroid-free clinical remission was evaluated at Week 30. Therapeutic drug level was monitored using a conventional enzyme-linked immunosorbent assay. In all, 210 consecutive inflammatory bowel disease [126 CD and 84 UC] patients were included in the present cohort. At Week 14, 81.4% of CD and 77.6% of UC patients showed clinical response and 53.6% of CD and 58.6% of UC patients were in clinical remission. Clinical remission rates at Week 14 were significantly higher in CD and UC patients who were infliximab naïve, compared with those with previous exposure to the originator compound [p < 0.05]. Until Week 30, adverse events were experienced in 17.1% of all patients. Infusion reactions and infectious adverse events occurred in 6.6% and 5.7% of all patients, respectively. This prospective multicentre cohort shows that CT-P13 is safe and effective in the induction of clinical remission and response in both CD and UC. Patients with previous infliximab exposure exhibited decreased response rates and were more likely to develop allergic reactions. Copyright © 2015 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  1. Aging of monolithic zirconia dental prostheses: Protocol for a 5-year prospective clinical study using ex vivo analyses.

    Science.gov (United States)

    Koenig, Vinciane; Wulfman, Claudine P; Derbanne, Mathieu A; Dupont, Nathalie M; Le Goff, Stéphane O; Tang, Mie-Leng; Seidel, Laurence; Dewael, Thibaut Y; Vanheusden, Alain J; Mainjot, Amélie K

    2016-12-15

    Recent introduction of computer-aided design/computer-aided manufacturing (CAD/CAM) monolithic zirconia dental prostheses raises the issue of material low thermal degradation (LTD), a well-known problem with zirconia hip prostheses. This phenomenon could be accentuated by masticatory mechanical stress. Until now zirconia LTD process has only been studied in vitro . This work introduces an original protocol to evaluate LTD process of monolithic zirconia prostheses in the oral environment and to study their general clinical behavior, notably in terms of wear. 101 posterior monolithic zirconia tooth elements (molars and premolars) are included in a 5-year prospective clinical trial. On each element, several areas between 1 and 2 mm 2 (6 on molars, 4 on premolars) are determined on restoration surface: areas submitted or non-submitted to mastication mechanical stress, glazed or non-glazed. Before prosthesis placement, ex vivo analyses regarding LTD and wear are performed using Raman spectroscopy, SEM imagery and 3D laser profilometry. After placement, restorations are clinically evaluated following criteria of the World Dental Federation (FDI), complemented by the analysis of fracture clinical risk factors. Two independent examiners perform the evaluations. Clinical evaluation and ex vivo analyses are carried out after 6 months and then each year for up to 5 years. For clinicians and patients, the results of this trial will justify the use of monolithic zirconia restorations in dental practice. For researchers, the originality of a clinical study including ex vivo analyses of material aging will provide important data regarding zirconia properties.Trial registration: ClinicalTrials.gov Identifier: NCT02150226.

  2. Promising approaches to circumvent the blood-brain barrier: progress, pitfalls and clinical prospects in brain cancer.

    Science.gov (United States)

    Papademetriou, Iason T; Porter, Tyrone

    2015-01-01

    Brain drug delivery is a major challenge for therapy of central nervous system (CNS) diseases. Biochemical modifications of drugs or drug nanocarriers, methods of local delivery, and blood-brain barrier (BBB) disruption with focused ultrasound and microbubbles are promising approaches which enhance transport or bypass the BBB. These approaches are discussed in the context of brain cancer as an example in CNS drug development. Targeting to receptors enabling transport across the BBB offers noninvasive delivery of small molecule and biological cancer therapeutics. Local delivery methods enable high dose delivery while avoiding systemic exposure. BBB disruption with focused ultrasound and microbubbles offers local and noninvasive treatment. Clinical trials show the prospects of these technologies and point to challenges for the future.

  3. Clinical science: prospects, payment and public policy.

    Science.gov (United States)

    Raslavicus, P A

    1999-01-01

    The last several decades of this century have witnessed significant changes in health care financing and delivery. Similar changes have occurred within laboratory medicine. While government involvement has been principally in insurance and the control of costs through regulation, the demise of the Clinton Health Plan ushered in an era of deregulation and market competition. In this environment, clinical science and clinical scientists have a new challenge: to prove their worth by establishing methods in which their services and tests are more clinically efficient than competing approaches.

  4. 77 FR 48989 - Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of...

    Science.gov (United States)

    2012-08-15

    ...] Draft Guidance for Industry on Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in... ``Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials.'' The purpose of... suicidal ideation and behavior in clinical trials of drug and biological products, including drugs for...

  5. A prospective study of twinning and perinatal mortality in urban Guinea-Bissau

    DEFF Research Database (Denmark)

    Bjerregaard-Andersen, Morten; Lund, Najaaraq; Jepsen, Frida Staarup

    2012-01-01

    ABSTRACT: BACKGROUND: Despite twinning being common in Africa, few prospective twin studies have been conducted. We studied twinning rate, perinatal mortality and the clinical characteristics of newborn twins in urban Guinea-Bissau. METHODS: The study was conducted at the Bandim Health Project (BHP......), a health and demographic surveillance site in Bissau, the capital of Guinea-Bissau. The cohort included all newborn twins delivered at the National Hospital Simao Mendes and in the BHP study area during the period September 2009 to August 2011 as well as singleton controls from the BHP study area. Data...... regarding obstetric history and pregnancy were collected at the hospital. Live children were examined clinically. For a subset of twin pairs zygosity was established by using genetic markers. RESULTS: Out of the 5262 births from mothers included in the BHP study area, 94 were twin births, i.e. a community...

  6. Comparison of toxin removal outcomes in online hemodiafiltration and intra-dialytic exercise in high-flux hemodialysis: A prospective randomized open-label clinical study protocol

    Directory of Open Access Journals (Sweden)

    Maheshwari Vaibhav

    2012-11-01

    Full Text Available Abstract Background Maintenance hemodialysis (HD patients universally suffer from excess toxin load. Hemodiafiltration (HDF has shown its potential in better removal of small as well as large sized toxins, but its efficacy is restricted by inter-compartmental clearance. Intra-dialytic exercise on the other hand is also found to be effective for removal of toxins; the augmented removal is apparently obtained by better perfusion of skeletal muscles and decreased inter-compartmental resistance. The aim of this trial is to compare the toxin removal outcome associated with intra-dialytic exercise in HD and with post-dilution HDF. Methods/design The main hypothesis of this study is that intra-dialytic exercise enhances toxin removal by decreasing the inter-compartmental resistance, a major impediment for toxin removal. To compare the HDF and HD with exercise, the toxin rebound for urea, creatinine, phosphate, and β2-microglobulin will be calculated after 2 hours of dialysis. Spent dialysate will also be collected to calculate the removed toxin mass. To quantify the decrease in inter-compartmental resistance, the recently developed regional blood flow model will be employed. The study will be single center, randomized, self-control, open-label prospective clinical research where 15 study subjects will undergo three dialysis protocols (a high flux HD, (b post-dilution HDF, (c high flux HD with exercise. Multiple blood samples during each study session will be collected to estimate the unknown model parameters. Discussion This will be the first study to investigate the exercise induced physiological change(s responsible for enhanced toxin removal, and compare the toxin removal outcome both for small and middle sized toxins in HD with exercise and HDF. Successful completion of this clinical research will give important insights into exercise effect on factors responsible for enhanced toxin removal. The knowledge will give confidence for implementing

  7. Adaptive radiotherapy for head and neck cancer—Dosimetric results from a prospective clinical trial

    International Nuclear Information System (INIS)

    Schwartz, David L.; Garden, Adam S.; Shah, Shalin J.; Chronowski, Gregory; Sejpal, Samir; Rosenthal, David I.; Chen, Yipei; Zhang, Yongbin; Zhang, Lifei; Wong, Pei-Fong; Garcia, John A.; Kian Ang, K.; Dong, Lei

    2013-01-01

    Purpose: To conduct a clinical trial evaluating adaptive head and neck radiotherapy (ART). Methods: Patients with locally advanced oropharyngeal cancer were prospectively enrolled. Daily CT-guided setup and deformable image registration permitted mapping of dose to avoidance structures and CTVs. We compared four planning scenarios: (1) original IMRT plan aligned daily to marked isocenter (BB); (2) original plan aligned daily to bone (IGRT); (3) IGRT with one adaptive replan (ART1); and (4) actual treatment received by each study patient (IGRT with one or two adaptive replans, ART2). Results: All 22 study patients underwent one replan (ART1); eight patients had two replans (ART2). ART1 reduced mean dose to contralateral parotid by 0.6 Gy or 2.8% (paired t-test; p = 0.003) and ipsilateral parotid by 1.3 Gy (3.9%) (p = 0.002) over the IGRT alone. ART2 further reduced the mean contralateral parotid dose by 0.8 Gy or 3.8% (p = 0.026) and ipsilateral parotid by 4.1 Gy or 9% (p = 0.001). ART significantly reduced integral body dose. Conclusions: This pilot trial suggests that head and neck ART dosimetrically outperforms IMRT. IGRT that leverages conventional PTV margins does not improve dosimetry. One properly timed replan delivers the majority of achievable dosimetric improvement. The clinical impact of ART must be confirmed by future trials

  8. An Exploration of Prospective Teachers' Learning of Clinical Interview Techniques

    Science.gov (United States)

    Groth, Randall E.; Bergner, Jennifer A.; Burgess, Claudia R.

    2016-01-01

    The present study followed four prospective teachers through the process of learning to interview during an undergraduate research project experience. Participants conducted and video recorded a series of interviews with children. They also carried out guided analyses of the videos and written artefacts from the interviews to formulate conjectures…

  9. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases

    International Nuclear Information System (INIS)

    Bagla, Sandeep; Sayed, Dawood; Smirniotopoulos, John; Brower, Jayson; Neal Rutledge, J.; Dick, Bradley; Carlisle, James; Lekht, Ilya; Georgy, Bassem

    2016-01-01

    BackgroundRadiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM.MethodsFifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval.ResultsTwenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported.ConclusionRFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

  10. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases.

    Science.gov (United States)

    Bagla, Sandeep; Sayed, Dawood; Smirniotopoulos, John; Brower, Jayson; Neal Rutledge, J; Dick, Bradley; Carlisle, James; Lekht, Ilya; Georgy, Bassem

    2016-09-01

    Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported. RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

  11. Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases

    Energy Technology Data Exchange (ETDEWEB)

    Bagla, Sandeep, E-mail: sandeep.bagla@gmail.com [Vascular Institute of Virginia, LLC (United States); Sayed, Dawood [University of Kansas Medical Center (United States); Smirniotopoulos, John [New York Presbyterian Hospital/Weill Cornell Medical Center (United States); Brower, Jayson [Providence Sacred Heart Medical Center and Children’s Hospital (United States); Neal Rutledge, J. [Seton Medical Center (United States); Dick, Bradley [Suburban Hospital (United States); Carlisle, James [St. Mark’s Hospital (United States); Lekht, Ilya [University of Southern California (United States); Georgy, Bassem [San Diego Imaging (United States)

    2016-09-15

    BackgroundRadiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM.MethodsFifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval.ResultsTwenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported.ConclusionRFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

  12. Clinic teaching made easy: a prospective study of the American Academy of Dermatology core curriculum in primary care learners.

    Science.gov (United States)

    McCleskey, Patrick E

    2013-08-01

    Dermatology instruction for primary care learners is limited, and the American Academy of Dermatology (AAD) has developed a new core curriculum for dermatology. This study sought to prospectively evaluate short-term knowledge acquisition and long-term knowledge retention after using the AAD core curriculum during a clinical dermatology clerkship. Resident physicians and physician assistant students performing clerkships at military dermatology clinics were given access to the AAD core curriculum teaching modules before their public availability. Knowledge acquisition was measured with pretests and posttests, and a follow-up quiz was given up to a year after the dermatology rotation to assess knowledge retention. In all, 82 primary care learners met inclusion criteria. Knowledge improved significantly from pretest to posttest (60.1 vs 77.4, P dermatology clerkship. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

  13. Multiple Intelligence and Digital Learning Awareness of Prospective B.Ed Teachers

    Science.gov (United States)

    Gracious, F. L. Antony; Shyla, F. L. Jasmine Anne

    2012-01-01

    The present study Multiple Intelligence and Digital Learning Awareness of prospective B.Ed teachers was probed to find the relationship between Multiple Intelligence and Digital Learning Awareness of Prospective B.Ed Teachers. Data for the study were collected using self made Multiple Intelligence Inventory and Digital Learning Awareness Scale.…

  14. Percutaneous nephrolithotomy among patients with renal anomalies: patient characteristics and outcomes; a subgroup analysis of the clinical research office of the endourological society global percutaneous nephrolithotomy study

    NARCIS (Netherlands)

    Osther, Palle Jörn; Razvi, Hassan; Liatsikos, Evangelos; Averch, Timothy; Crisci, Alfonso; Garcia, Juan Lòpez; Mandal, Arup; de la Rosette, Jean

    2011-01-01

    This study compared the characteristics and outcomes of percutaneous nephrolithotomy (PCNL) in patients with and without renal malformations using the Clinical Research Office of the Endourological Society (CROES) PCNL Global Study database. The CROES PCNL Global Study collected prospective data for

  15. Travel style is a major risk factor for diarrhoea in India: a prospective cohort study.

    Science.gov (United States)

    Schindler, V M; Jaeger, V K; Held, L; Hatz, C; Bühler, S

    2015-07-01

    Although some studies suggested specific foods/beverages as risk factors for travellers' diarrhoea (TD), details of transmission remain unclear. We assessed the influence of travel style (luxury/middle-class versus backpacking) on TD risk. TD attack rates were compared in a prospective study among travellers to India at the University of Zurich's Travel Clinic. Information on consumption of foods/beverages was collected. Seventy-one luxury/middle-class travellers and 21 backpackers completed the study; overall 37% suffered from TD (62% backpackers, 30% luxury/middle-class travellers, OR 4.43, p 0.022). Travel style rather than the consumption of specific foods/beverages appears to be a risk factor for TD development. Copyright © 2015 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  16. A Clinical Risk Score for Atrial Fibrillation in a Biracial Prospective Cohort (From the Atherosclerosis Risk in Communities (ARIC) Study)

    OpenAIRE

    Chamberlain, Alanna M.; Agarwal, Sunil K.; Folsom, Aaron R.; Soliman, Elsayed Z.; Chambless, Lloyd E.; Crow, Richard; Ambrose, Marietta; Alonso, Alvaro

    2011-01-01

    A risk score for AF has been developed by the Framingham Heart Study; however the applicability of this risk score, derived from whites, to predict new-onset AF in non-whites is uncertain. Therefore, we developed a 10-year risk score for new-onset AF using risk factors commonly measured in clinical practice using 14,546 individuals from the Atherosclerosis Risk in Communities study, a prospective community-based cohort of blacks and whites in the United States. During 10 years of follow-up, 5...

  17. Clinical and angiographic characteristics of patients likely to have vulnerable plaques: analysis from the PROSPECT study.

    Science.gov (United States)

    Bourantas, Christos V; Garcia-Garcia, Hector M; Farooq, Vasim; Maehara, Akiko; Xu, Ke; Généreux, Philippe; Diletti, Roberto; Muramatsu, Takashi; Fahy, Martin; Weisz, Giora; Stone, Gregg W; Serruys, Patrick W

    2013-12-01

    This study sought to determine the clinical and angiographic variables that would identify patients with high-risk "vulnerable" coronary plaques. In the PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) study, in patients successfully treated for acute coronary syndrome (ACS), plaque composition, plaque burden, and minimal luminal area as detected by 3-vessel radiofrequency intravascular ultrasound (IVUS) imaging were associated with an increased risk of developing future events from untreated atherosclerotic lesions (vulnerable plaques). Whether baseline demographic and angiographic findings can be used to identify patients most likely to have vulnerable coronary plaques has not been examined. On the basis of 3-vessel radiofrequency IVUS imaging, patents in the PROSPECT trial were classified in 2 groups according to whether or not one or more untreated high-risk plaques were present, defined as having ≥2 high-risk features (a thin-cap fibroatheroma, plaque burden ≥70%, and/or minimal luminal area ≤4 mm(2)). The high-risk group (those with one or more high-risk lesions) had higher Framingham risk score (7.5 ± 3.4 vs. 6.9 ± 3.3; p = 0.04), more extensive coronary artery disease, and more nonculprit lesion-related cardiovascular events during the 3-year follow-up (hazard ratio: 2.63; 95% confidence interval: 1.62 to 3.66; p < 0.0001). However, demographic factors had poor discrimination in detecting high-risk patients (area under the curve 0.55), and discrimination was only slightly improved when angiographic variables were entered into the model (area under the curve 0.64). Clinical and angiographic characteristics had poor predictive accuracy in identifying patients with untreated high-risk plaques related to future adverse events. This finding highlights the potential value of comprehensive 3-vessel imaging assessment (either invasive or noninvasive) to evaluate plaque phenotype for more accurate risk

  18. Improved clinical documentation leads to superior reportable outcomes: An accurate representation of patient's clinical status.

    Science.gov (United States)

    Elkbuli, Adel; Godelman, Steven; Miller, Ashley; Boneva, Dessy; Bernal, Eileen; Hai, Shaikh; McKenney, Mark

    2018-05-01

    Clinical documentation can be an underappreciated. Trauma Centers (TCs) are now routinely evaluated for quality performance. TCs with poor documentation may not accurately reflect actual injury burden or comorbidities and can impact accuracy of mortality measures. Markers exist to adjust crude death rates for injury severity: observed over expected deaths (O/E) adjust for injury; Case Mix Index (CMI) reflects disease burden, and Severity of Illness (SOI) measures organ dysfunction. We aim to evaluate the impact of implementing a Clinical Documentation Improvement Program (CDIP) on reported outcomes. Review of 2-years of prospectively collected data for trauma patients, during the implementation of CDIP. A two-group prospective observational study design was used to evaluate the pre-implementation and the post-implementation phase of improved clinical documentation. T-test and Chi-Squared were used with significance defined as p deaths out of 1419 (3.45%), while post-implementation period, had 38 deaths out of 1454 (2.61%), (non-significant). There was however, a significant difference between O/E ratios. In the pre-phase, the O/E was 1.36 and 0.70 in the post-phase (p < 0.001). The two groups also differed on CMI with a pre-group mean of 2.48 and a post-group of 2.87 (p < 0.001), indicating higher injury burden in the post-group. SOI started at 2.12 and significantly increased to 2.91, signifying more organ system dysfunction (p < 0.018). Improved clinical documentation results in improved accuracy of measures of mortality, injury severity, and comorbidities and a more accurate reflection in O/E mortality ratios, CMI, and SOI. Copyright © 2018 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  19. The Opinions of Prospective Teachers about Peer Assessment

    Directory of Open Access Journals (Sweden)

    Erdal Bay

    2011-12-01

    Full Text Available Introduction: Peer assessment has been popular in teacher education for decades. In this study, the opinions of prospective teachers about peer-assessment after an implemented course were collected. The correlation between peer-assessment scores and those of self-assessment and teacher assessments were also investigated. Method: A survey was administered to 56 prospective teachers taking the “Measurement and Evaluation” course in the department of English language teaching. Peer assessment, as well as self-evaluation and teacher-based assessment were applied in the study. To collect the data, open-ended questionnaires and interview forms were employed. Finding: The results indicated that that prospective teacher thought that they acquired professional skills through peer assessment. They also perceived that peer assessment enhanced the quality of learning, provided constructive feedback in learning process, and enabled them to obtain some democratic values. It was also regarded as a tiring and time-consuming activity. Lastly, as parallel to the literature, prospective teachers criticized peer assessment that they were not capable of evaluating themselves effectively because of several reasons such as peer-effect, emotional improper acts and unreliability among peers against each other‟s. Besides, significant a positive correlation was found among peer, self and teacher assessment scores. Conclusion: In conclusion, secrecy, usage of the rubrics, better comprehension of the criteria, training of prospective teachers in evaluation, and spending less time can be the factors that affect the peer assessment. Teachers are suggested that they should adopt contemporary measurement and evaluation techniques reflected within constructivist implementations in learning environments

  20. The clinical assessment study of the foot (CASF: study protocol for a prospective observational study of foot pain and foot osteoarthritis in the general population

    Directory of Open Access Journals (Sweden)

    Menz Hylton B

    2011-09-01

    Full Text Available Abstract Background Symptomatic osteoarthritis (OA affects approximately 10% of adults aged over 60 years. The foot joint complex is commonly affected by OA, yet there is relatively little research into OA of the foot, compared with other frequently affected sites such as the knee and hand. Existing epidemiological studies of foot OA have focussed predominantly on the first metatarsophalangeal joint at the expense of other joints. This three-year prospective population-based observational cohort study will describe the prevalence of symptomatic radiographic foot OA, relate its occurrence to symptoms, examination findings and life-style-factors, describe the natural history of foot OA, and examine how it presents to, and is diagnosed and managed in primary care. Methods All adults aged 50 years and over registered with four general practices in North Staffordshire, UK, will be invited to participate in a postal Health Survey questionnaire. Respondents to the questionnaire who indicate that they have experienced foot pain in the preceding twelve months will be invited to attend a research clinic for a detailed clinical assessment. This assessment will consist of: clinical interview; physical examination; digital photography of both feet and ankles; plain x-rays of both feet, ankles and hands; ultrasound examination of the plantar fascia; anthropometric measurement; and a further self-complete questionnaire. Follow-up will be undertaken in consenting participants by postal questionnaire at 18 months (clinic attenders only and three years (clinic attenders and survey participants, and also by review of medical records. Discussion This three-year prospective epidemiological study will combine survey data, comprehensive clinical, x-ray and ultrasound assessment, and review of primary care records to identify radiographic phenotypes of foot OA in a population of community-dwelling older adults, and describe their impact on symptoms, function and

  1. A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic.

    Science.gov (United States)

    Guzek, Lindsay M; Fadel, William F; Golomb, Meredith R

    2015-09-01

    Missed clinic appointments lead to decreased patient access, worse patient outcomes, and increased healthcare costs. The goal of this pilot study was to identify reasons for and risk factors associated with missed pediatric neurology outpatient appointments ("no-shows"). This was a prospective cohort study of patients scheduled for 1 week of clinic. Data on patient clinical and demographic information were collected by record review; data on reasons for missed appointments were collected by phone interviews. Univariate and multivariate analyses were conducted using chi-square tests and multiple logistic regression to assess risk factors for missed appointments. Fifty-nine (25%) of 236 scheduled patients were no-shows. Scheduling conflicts (25.9%) and forgetting (20.4%) were the most common reasons for missed appointments. When controlling for confounding factors in the logistic regression, Medicaid (odds ratio 2.36), distance from clinic, and time since appointment was scheduled were associated with missed appointments. Further work in this area is needed. © The Author(s) 2014.

  2. Consistency between Constructivist Profiles and Instructional Practices of Prospective Physics Teachers

    Science.gov (United States)

    Ates, Ozlem; Unal Coban, Gul; Kaya Sengoren, Serap

    2018-01-01

    This study aims to explain the extent to which prospective physics teachers' views and practices are consistent with the constructivist framework. A case study design was employed as the research approach. The study was conducted with 11 prospective physics teachers attending a state university in Turkey. Data was collected through semi-structured…

  3. A Prospective Evaluation of Helical Tomotherapy

    International Nuclear Information System (INIS)

    Bauman, Glenn; Yartsev, Slav; Rodrigues, George; Lewis, Craig; Venkatesan, Varagur M.; Yu, Edward; Hammond, Alex; Perera, Francisco; Ash, Robert; Dar, A. Rashid; Lock, Michael; Baily, Laura; Coad, Terry C; Trenka, Kris C.; Warr, Barbara; Kron, Tomas; Battista, Jerry; Van Dyk, Jake

    2007-01-01

    Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT in 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting

  4. Bringing explicit insight into cognitive psychology features during clinical reasoning seminars: a prospective, controlled study.

    Science.gov (United States)

    Nendaz, Mathieu R; Gut, Anne M; Louis-Simonet, Martine; Perrier, Arnaud; Vu, Nu V

    2011-04-01

    Facets of reasoning competence influenced by an explicit insight into cognitive psychology features during clinical reasoning seminars have not been specifically explored. This prospective, controlled study, conducted at the University of Geneva Faculty of Medicine, Switzerland, assessed the impact on sixth-year medical students' patient work-up of case-based reasoning seminars, bringing them explicit insight into cognitive aspects of their reasoning. Volunteer students registered for our three-month Internal Medicine elective were assigned to one of two training conditions: standard (control) or modified (intervention) case-based reasoning seminars. These seminars start with the patient's presenting complaint and the students must ask the tutor for additional clinical information to progress through case resolution. For this intervention, the tutors made each step explicit to students and encouraged self-reflection on their reasoning processes. At the end of their elective, students' performances were assessed through encounters with two standardized patients and chart write-ups. Twenty-nine students participated, providing a total of 58 encounters. The overall differences in accuracy of the final diagnosis given to the patient at the end of the encounter (control 63% vs intervention 74%, p = 0.53) and of the final diagnosis mentioned in the patient chart (61% vs 70%, p = 0.58) were not statistically significant. The students in the intervention group significantly more often listed the correct diagnosis among the differential diagnoses in their charts (75% vs 97%, p = 0.02). This case-based clinical reasoning seminar intervention, designed to bring students insight into cognitive features of their reasoning, improved aspects of diagnostic competence.

  5. Clinic-cytologic study of conjunctivochalasis and its relation to thyroid autoimmune diseases: prospective cohort study.

    Science.gov (United States)

    de Almeida, Sandra Flavia Fiorentini; de Sousa, Luciene B; Vieira, Luis A; Chiamollera, Maria I; Barros, Jeison de N

    2006-08-01

    To determine the prevalence of conjunctivochalasis in patients with immune thyroid diseases, to determine whether there is any association between the 2 diseases, and to determine cytologic study of conjunctivochalasis through the cytology impression test. A clinical prospective cohort study carried out by the External Diseases Department in the Ophthalmology Sector and the Thyroid Department in the Endocrinology Sector at Federal University of Sao Paulo (UNIFESP). The patients included were divided into 2 groups following these inclusion criteria: a control group of 25 patients without thyroid diseases, confirmed after clinical and laboratory examinations (thyroid hormones), or any other ocular diseases. The study group consisted of 31 patients with thyroid diseases, the diagnosis of which was confirmed by the Endocrinology Sector. The thyroidopathies included were autoimmune diseases but excluded nonautoimmune diseases. A protocol endorsed by the UNIFESP was followed, using clinical and ophthalmological history, biomicroscopy, and impression cytology. Fifty-two percent of patients without thyroid diseases and 88% of patients with thyroid diseases presented with conjunctivochalasis. The risk ratio was 1.705 (Pr > chi(2) = 0.0038), indicating that there is an association between them. For the impression cytology in inferior bulbar conjunctiva, there was an association between the result of the impression cytology and conjunctivochalasis (Pearson chi(2) = 10.1190 Pr = 0.006). The prevalence of conjunctivochalasis in patients with autoimmune thyroid diseases was 88%. Patients with autoimmune thyroidopathy presented higher percentages of conjunctivochalasis than the control group, confirming the association between them. The cytologic study showed the highest prevalence of abnormal surface features in eyes with conjunctivochalasis.

  6. RNA isolation from bloodstains collected on FTA cards – application in clinical and forensic genetics

    Directory of Open Access Journals (Sweden)

    Katarzyna Skonieczna

    2017-06-01

    Full Text Available Aim of the study : In recent years, RNA analysis has been increasingly used in clinical and forensic genetics. Nevertheless, a major limitation of RNA-based applications is very low RNA stability in biological material, due to the RNAse activity. This highlights the need for improving the methods of RNA collection and storage. Technological approaches such as FTA Classic Cards (Whatman could provide a solution for the problem of RNA degradation. However, different methods of RNA isolation from FTA cards could have diverse effects on RNA quantity and quality. The purpose of this research was to analyze the utility of three different methods of RNA isolation from peripheral blood collected on FTA Classic Cards (Whatman. The study also aimed at assessing RNA stability in bloodstains deposited on FTA cards. Material and methods : The study was performed on peripheral bloodstains collected from 59 individuals on FTA Classic Cards (Whatman. RNA was isolated with High Pure RNA Isolation Kit (Roche Diagnostics, Universal RNA/miRNA Purification (EURx and TRIzol Reagent (Life Technologies. RNA was subjected to quantitative analysis followed by reverse transcription and Real – Time PCR reaction. Results : The study has shown that FTA Classic Cards (Whatman are useful tools for storing bloodstains at room temperature for RNA analysis. Moreover, the method of RNA extraction employing TRIzol Reagent (Life Technologies provides the highest efficiency and reproducibility for samples stored for no more than 2 years. Conclusions : The FTA cards are suitable for collecting and storing bloodstains for RNA analysis in clinical and forensic genetics.

  7. Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST Study). 50 patients prospective study

    International Nuclear Information System (INIS)

    Costalat, V.; Lobotesis, K.; Machi, P.; Mourand, I.; Maldonado, I.; Heroum, C.; Vendrell, J.F.; Milhaud, D.; Riquelme, C.; Bonafé, A.; Arquizan, C.

    2012-01-01

    Background and aims: New thrombectomy devices allow successful and rapid recanalization in acute ischemic stroke. Nevertheless prognostics factors need to be systematically analyzed in the context of these new therapeutic strategies. The aim of this study was to analyze prognostic factors related to clinical outcome following Solitaire FR thrombectomy in ischemic stroke. Methods: Fifty consecutive ischemic stroke patients with large vessel occlusion were included. Three treatment strategies were applied; rescue therapy, combined therapy, and standalone thrombectomy. DWI ASPECT score < 5 was the main exclusion criterion after initial MRI (T2, T2*, TOF, FLAIR, DWI). Sexes, age, time to recanalization were prospectively collected. Clinical outcome was assessed post treatment, day one and discharge by means of a NIHSS. Three months mRS evaluation was performed by an independent neurologist. The probability of good outcome at 3 months was assessed by forward stepwise logistic regression using baseline NIHSS score, Glasgow score at entrance, hyperglycemia, dyslipidemia, blood–brain barrier disruption on post-operative CT, embolic and hemorrhagic post procedural complication, ischemic brain lesion extension on 24 h imaging, NIHSS at discharge, ASPECT score, and time to recanalization. All variables significantly associated with the outcome in the univariate analysis were entered in the model. The significance of adding or removing a variable from the logistic model was determined by the maximum likelihood ratio test. Odds-ratio (OR) and their 95% confidence intervals were calculated. Results: At 3 months 54% of patients had a mRS 0–2, 70% in MCA, 44% in ICA, and 43% in BA with an overall mortality rate of 12%. Baseline NIHSS score (p = 0.001), abnormal Glasgow score at entrance (p = 0.053) hyperglycemia (p = 0.023), dyslipidemia (p = 0.031), blood–brain barrier disruption (p = 0.022), embolic and hemorrhagic post procedural complication, ischemic brain lesion

  8. Prognostic factors related to clinical outcome following thrombectomy in ischemic stroke (RECOST Study). 50 patients prospective study

    Energy Technology Data Exchange (ETDEWEB)

    Costalat, V., E-mail: vincentcost@hotmail.com [CHU Montpellier, Neuroradiology, Montpellier (France); Lobotesis, K., E-mail: kyriakos@lobotesis.co.uk [CHU Montpellier, Neuroradiology, Montpellier (France); Machi, P., E-mail: paolo.machi@gmail.com [CHU Montpellier, Neuroradiology, Montpellier (France); Mourand, I., E-mail: i-mourand@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Maldonado, I., E-mail: imaldonado@terra.com.br [CHU Montpellier, Neuroradiology, Montpellier (France); Heroum, C., E-mail: c-heroum@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Vendrell, J.F., E-mail: jf-vendrell@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Milhaud, D., E-mail: d-milhaud@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France); Riquelme, C., E-mail: c-riquelme@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Bonafé, A., E-mail: a-bonafe@chu-montpellier.fr [CHU Montpellier, Neuroradiology, Montpellier (France); Arquizan, C., E-mail: c-arquizan@chu-montpellier.fr [CHU Montpellier, Neurology, Montpellier (France)

    2012-12-15

    Background and aims: New thrombectomy devices allow successful and rapid recanalization in acute ischemic stroke. Nevertheless prognostics factors need to be systematically analyzed in the context of these new therapeutic strategies. The aim of this study was to analyze prognostic factors related to clinical outcome following Solitaire FR thrombectomy in ischemic stroke. Methods: Fifty consecutive ischemic stroke patients with large vessel occlusion were included. Three treatment strategies were applied; rescue therapy, combined therapy, and standalone thrombectomy. DWI ASPECT score < 5 was the main exclusion criterion after initial MRI (T2, T2*, TOF, FLAIR, DWI). Sexes, age, time to recanalization were prospectively collected. Clinical outcome was assessed post treatment, day one and discharge by means of a NIHSS. Three months mRS evaluation was performed by an independent neurologist. The probability of good outcome at 3 months was assessed by forward stepwise logistic regression using baseline NIHSS score, Glasgow score at entrance, hyperglycemia, dyslipidemia, blood–brain barrier disruption on post-operative CT, embolic and hemorrhagic post procedural complication, ischemic brain lesion extension on 24 h imaging, NIHSS at discharge, ASPECT score, and time to recanalization. All variables significantly associated with the outcome in the univariate analysis were entered in the model. The significance of adding or removing a variable from the logistic model was determined by the maximum likelihood ratio test. Odds-ratio (OR) and their 95% confidence intervals were calculated. Results: At 3 months 54% of patients had a mRS 0–2, 70% in MCA, 44% in ICA, and 43% in BA with an overall mortality rate of 12%. Baseline NIHSS score (p = 0.001), abnormal Glasgow score at entrance (p = 0.053) hyperglycemia (p = 0.023), dyslipidemia (p = 0.031), blood–brain barrier disruption (p = 0.022), embolic and hemorrhagic post procedural complication, ischemic brain lesion

  9. Resident trainees do not affect patient satisfaction in an outpatient gastroenterology clinic: a prospective study conducted in a Canadian gastroenterology clinic.

    Science.gov (United States)

    Brahmania, Mayur; Young, Madison; Muthiah, Chetty; Ilnyckyj, Alexandra; Duerksen, Donald; Moffatt, Dana C

    2015-10-01

    There is little literature regarding how a gastroenterology trainee affects a patient's interpretation of care during outpatient clinic visits. Improving patient satisfaction is desirable and benefits may include enhanced patient compliance as well as providing trainees with areas for improvement. To evaluate patient satisfaction in an outpatient gastroenterology clinic when seen by a trainee and attending physician versus an attending physician alone. The secondary objective was to evaluate physician characteristics that play a role in creating a positive clinical experience. A randomized prospective survey study was conducted over an 11-month period (July 2012 to June 2013) at St Boniface Hospital (Winnipeg, Manitoba). Two gastroenterology fellows (postgraduate year 4 and 5) and nine internal medicine residents (postgraduate year 1 to 3) comprised the 'trainee' role, while three academic clinicians comprised the 'attending' role. Patients included individuals seen for an initial consultation and were >18 years of age. A total of 211 patients comprised the final study group, with 118 in the attending group and 93 in the trainee group. In univariate analysis, patients more often had a very good experience when seen by an attending physician alone versus a trainee and attending physician (73% versus 56%; P=0.016); however, on multivariate analysis, there was no significant difference in patient satisfaction (OR 0.89; P=0.931). Physician factors found to be associated with high patient satisfaction on multivariate analysis included: addressing all patient concerns (OR 27.56; P=0.021); giving the patient a preliminary diagnosis (OR 78.02; P=0.006); and feeling the physician was thorough (OR 72.53; P=0.029). The present study did not reveal a difference in patient satisfaction if a patient sees an attending physician alone or with a trainee. Moreover, to improve patient satisfaction in a gastroenterology clinic, physicians should address all patient concerns, provide a

  10. β-trace protein as a diagnostic marker for perilymphatic fluid fistula: a prospective controlled pilot study to test a sample collection technique.

    Science.gov (United States)

    Bachmann-Harildstad, Gregor; Stenklev, Niels Christian; Myrvoll, Elin; Jablonski, Greg; Klingenberg, Olav

    2011-01-01

    The diagnosis of perilymphatic fluid (PLF) fistula is still challenging. Perilymphatic fluid fistula is one possible complication after stapedotomy or cochlear implant surgery. We have performed a prospective diagnostic pilot study to further investigate β-trace protein (β-TP) as a marker for PLF fistula. In this pilot study, we tested the sensitivity of the β-TP marker using a simple method for sample collection from the tympanic cavity. Prospective controlled diagnostic study. Two-center tertiary referral hospitals. A total of 35 adult patients undergoing ear surgery were included. Subjects were divided into 2 groups: 1) 19 patients undergoing stapedotomy were investigated for PLF fistula in samples obtained from the tympanic cavity and 2) 16 patients undergoing myringoplasty were investigated for PLF fistula in samples from the tympanic cavity. This group served as the control. Mean age +/- SD at surgery was 49.9 +/- 8.0 years in the study group and 39.69 +/- 15.47 years in the control group. β-Trace protein (prostaglandin D synthase) in tympanic cavity samples and serum samples was analyzed. The samples were collected by gradually filling the tympanic cavity with 100 to 200 μl sodium chloride and by immediately collecting a volume of 60 to 100 μl in a mucus specimen set container. The concentration of β-TP was quantified using laser nephelometry. The median β-TP in the study group was 0.8 mg/L (range, 0.05-4.5 mg/L). In the control group, the median β-TP value was 0.16 mg/L (range, 0.01-0.36 mg/L). Thirty-five percent of the values in the study group were below the highest value in the negative control group. The β-TP values of the tympanic cavity samples were significantly higher in the study group than in controls (p = 0.0001). The serum values were 0.55 +/- 0.18 and 0.53 +/- 0.11 mg/L, respectively. It may be feasible to test for PLF fistula using β-TP in samples from the tympanic cavity. Our results, however, suggest a relative low diagnostic

  11. A prospective study of injuries sustained during competitive Muay Thai kickboxing.

    Science.gov (United States)

    Gartland, Sam; Malik, Mohammad Hammad; Lovell, Martyn

    2005-01-01

    To investigate prospectively the type and rate of injuries sustained during amateur Muay Thai competition. Prospective cohort study collection of data following clinical examination. Amateur Muay Thai competitions in the United Kingdom organized by the International Amateur Muay Thai Federation. Amateur Muay Thai boxers. Both sexes. Lightweight to super heavyweight. There were 92 participants, 12 females and 82 males. The average age was 17.3 years, and the average previous number of bouts was 3.9. A total of 588.5 minutes of competition time was assessed during a total of 10 events. Injury rates were 1.3 injuries per 100 minutes of competition in the lightweight category, 2.25 per 100 minutes of competition in the middleweight category, 30 per 100 minutes of competition in the heavyweight category, and 2.54 per 100 minutes of competition in the super heavyweight category. Compared with other reported martial arts, the injury rates are higher in Muay Thai. The head was shown to be the most common site of injury in amateur fighters, but there was an almost complete absence of lower limb injuries, which again is at variance with reported figures for other martial arts.

  12. A prospective, controlled clinical evaluation of surgical stabilization of severe rib fractures.

    Science.gov (United States)

    Pieracci, Fredric M; Lin, Yihan; Rodil, Maria; Synder, Madelyne; Herbert, Benoit; Tran, Dong Kha; Stoval, Robert T; Johnson, Jeffrey L; Biffl, Walter L; Barnett, Carlton C; Cothren-Burlew, Clay; Fox, Charles; Jurkovich, Gregory J; Moore, Ernest E

    2016-02-01

    Previous studies of surgical stabilization of rib fractures (SSRF) have been limited by small sample sizes, retrospective methodology, and inclusion of only patients with flail chest. We performed a prospective, controlled evaluation of SSRF as compared with optimal medical management for severe rib fracture patterns among critically ill trauma patients. We hypothesized that SSRF improves acute outcomes. We conducted a 2-year clinical evaluation of patients with any of the following rib fracture patterns: flail chest, three or more fractures with bicortical displacement, 30% or greater hemithorax volume loss, and either severe pain or respiratory failure despite optimal medical management. In the year 2013, all patients were managed nonoperatively. In the year 2014, all patients were managed operatively. Outcomes included respiratory failure, tracheostomy, pneumonia, ventilator days, tracheostomy, length of stay, daily maximum incentive spirometer volume, narcotic requirements, and mortality. Univariate and multivariable analyses were performed. Seventy patients were included, 35 in each group. For the operative group, time from injury to surgery was 2.4 day, operative time was 1.5 hours, and the ratio of ribs fixed to ribs fractured was 0.6. The operative group had a significantly higher RibScore (4 vs. 3, respectively, p fracture patterns. Therapeutic study, level II.

  13. Impact of BMI on clinical outcomes of NOAC therapy in daily care - Results of the prospective Dresden NOAC Registry (NCT01588119).

    Science.gov (United States)

    Tittl, L; Endig, S; Marten, S; Reitter, A; Beyer-Westendorf, I; Beyer-Westendorf, J

    2018-03-14

    Direct acting non-Vitamin K antagonist oral anticoagulants (NOAC) are characterized by a fixed dosing regimen. Despite the potential for relative underdosing due to large distribution volumes, dose adjustments for patients with high body mass index (BMI) are not recommended. Since efficacy and safety data in obese patients are scarce, we evaluated the impact of BMI on clinical outcomes in daily care patients treated with NOAC for stroke prevention in atrial fibrillation or venous thromboembolism. Using prospectively collected data from a non-interventional registry, cardiovascular (CV), major bleeding events (MB) and all-cause mortality were evaluated according to BMI classes. All outcome events were centrally adjudicated using standard scientific definitions. Between November 1st 2011 and December 31st 2016, 3432 patients were enrolled into the registry (61.3% rivaroxaban; 20% apixaban; 10.1% dabigatran, 8.6% edoxaban; mean follow-up 998.1 ± 542.9 days; median 1004 days). With increasing BMI (range 13.7-57.2 kg/m 2 ), the proportion of patients receiving standard (vs. reduced) NOAC dose increased from 64.7% (underweight) to 78.9% (obesity). Although obese patients had more cardiovascular risk factors compared to normal weight patients, on-treatment rates of clinical outcomes (CV, MB, all-cause-mortality) were lowest in overweight and obese patients. In a large set of real-life NOAC recipients we found no indication that high BMI is associated with inferior NOAC effectiveness or safety, which is in line with recent epidemiological data of a "BMI paradox" that indicates a somewhat protective effect of higher BMI regarding unfavourable outcomes also in patients receiving fixed dose NOAC anticoagulation without dose adjustment for higher BMI. Copyright © 2017. Published by Elsevier B.V.

  14. Phenotypic ASCO Characterisation of Young Patients with Ischemic Stroke in the Prospective Multicentre Observational sifap1 Study.

    Science.gov (United States)

    Wolf, Marc E; Grittner, Ulrike; Böttcher, Tobias; Norrving, Bo; Rolfs, Arndt; Hennerici, Michael G

    2015-01-01

    The prospective, multinational European 'Stroke in Young Fabry Patients' (sifap1) study collected 4,467 patients with acute ischemic cerebrovascular events aged 18-55 years. Initially, aetiologic subtyping was performed using the TOAST classification; however, recently the phenotypic ASCO classification was presented and might be more useful to identify stroke aetiologies in young patients with a wide set of different causes. ASCO is a classification system divided in four etiologic categories (Atherosclerosis, Small vessel disease (SVD), Cardiac embolism, Other cause) with different grades of severity (1-3) and aims to characterise patients in a more comprehensive way. We determined the ASCO score for each patient, according to prospectively collected data using the study protocol. The distribution of aetiologies was analysed with regard to concomitant causes, cryptogenic stroke and different age groups. A potentially causal aetiology (grade 1) was detected in 29.3% of 4,467 patients. Merging grades 1 and 2, a suspected aetiology was found in 54.1%. In 8.6% of patients concomitant aetiologies were identified. Most common causes were cervical arterial dissection and persistent foramen ovale, but there was also a high prevalence of large artery atherosclerosis and SVD especially in older patients of this collective. About 50% of patients had more than one finding with a lower grade of evidence (grade 3). In 14% final classification of strictly cryptogenic stroke was made. This is the largest study to date, using the ASCO characterisation of ischemic stroke aetiologies. ASCO classification provides first evidence that many young patients presenting with acute stroke have concomitant stroke aetiologies associated with a substantial atherosclerosis risk profile. ASCO could be integrated in clinical routine and registry data banks, as well as large clinical trials to improve stroke documentation. © 2015 S. Karger AG, Basel.

  15. The effect on prospective teachers of the learning environment supported by dynamic statistics software

    Science.gov (United States)

    Koparan, Timur

    2016-02-01

    In this study, the effect on the achievement and attitudes of prospective teachers is examined. With this aim ahead, achievement test, attitude scale for statistics and interviews were used as data collection tools. The achievement test comprises 8 problems based on statistical data, and the attitude scale comprises 13 Likert-type items. The study was carried out in 2014-2015 academic year fall semester at a university in Turkey. The study, which employed the pre-test-post-test control group design of quasi-experimental research method, was carried out on a group of 80 prospective teachers, 40 in the control group and 40 in the experimental group. Both groups had four-hour classes about descriptive statistics. The classes with the control group were carried out through traditional methods while dynamic statistics software was used in the experimental group. Five prospective teachers from the experimental group were interviewed clinically after the application for a deeper examination of their views about application. Qualitative data gained are presented under various themes. At the end of the study, it was found that there is a significant difference in favour of the experimental group in terms of achievement and attitudes, the prospective teachers have affirmative approach to the use of dynamic software and see it as an effective tool to enrich maths classes. In accordance with the findings of the study, it is suggested that dynamic software, which offers unique opportunities, be used in classes by teachers and students.

  16. Using Big Data in oncology to prospectively impact clinical patient care: A proof of concept study.

    Science.gov (United States)

    Dougoud-Chauvin, Vérène; Lee, Jae Jin; Santos, Edgardo; Williams, Vonetta L; Battisti, Nicolò M L; Ghia, Kavita; Sehovic, Marina; Croft, Cortlin; Kim, Jongphil; Balducci, Lodovico; Kish, Julie A; Extermann, Martine

    2018-04-17

    Big Data is widely seen as a major opportunity for progress in the practice of personalized medicine, attracting the attention from medical societies and presidential teams alike as it offers a unique opportunity to enlarge the base of evidence, especially for older patients underrepresented in clinical trials. This study prospectively assessed the real-time availability of clinical cases in the Health & Research Informatics Total Cancer Care™ (TCC) database matching community patients with cancer, and the impact of such a consultation on treatment. Patients aged 70 and older seen at the Lynn Cancer Institute (LCI) with a documented malignancy were eligible. Geriatric screening information and the oncologist's pre-consultation treatment plan were sent to Moffitt. A search for similar patients was done in TCC and additional information retrieved from Electronic Medical Records. A report summarizing the data was sent and the utility of such a consultation was assessed per email after the treatment decision. Thirty one patients were included. The geriatric screening was positive in 87.1% (27) of them. The oncogeriatric consultation took on average 2.2 working days. It influenced treatment in 38.7% (12), and modified it in 19.4% (6). The consultation was perceived as "somewhat" to "very useful" in 83.9% (26). This study establishes a proof of concept of the feasibility of real time use of Big Data for clinical practice. The geriatric screening and the consultation report influenced treatment in 38.7% of cases and modified it in 19.4%, which compares very well with oncogeriatric literature. Additional steps are needed to render it financially and clinically viable. Copyright © 2018 Elsevier Inc. All rights reserved.

  17. [Contemplation on the application of big data in clinical medicine].

    Science.gov (United States)

    Lian, Lei

    2015-01-01

    Medicine is another area where big data is being used. The link between clinical treatment and outcome is the key step when applying big data in medicine. In the era of big data, it is critical to collect complete outcome data. Patient follow-up, comprehensive integration of data resources, quality control and standardized data management are the predominant approaches to avoid missing data and data island. Therefore, establishment of systemic patients follow-up protocol and prospective data management strategy are the important aspects of big data in medicine.

  18. The Pancreatitis Activity Scoring System predicts clinical outcomes in acute pancreatitis: findings from a prospective cohort study.

    Science.gov (United States)

    Buxbaum, James; Quezada, Michael; Chong, Bradford; Gupta, Nikhil; Yu, Chung Yao; Lane, Christianne; Da, Ben; Leung, Kenneth; Shulman, Ira; Pandol, Stephen; Wu, Bechien

    2018-03-15

    The Pancreatitis Activity Scoring System (PASS) has been derived by an international group of experts via a modified Delphi process. Our aim was to perform an external validation study to assess for concordance of the PASS score with high face validity clinical outcomes and determine specific meaningful thresholds to assist in application of this scoring system in a large prospectively ascertained cohort. We analyzed data from a prospective cohort study of consecutive patients admitted to the Los Angeles County Hospital between March 2015 and March 2017. Patients were identified using an emergency department paging system and electronic alert system. Comprehensive characterization included substance use history, pancreatitis etiology, biochemical profile, and detailed clinical course. We calculated the PASS score at admission, discharge, and at 12 h increments during the hospitalization. We performed several analyses to assess the relationship between the PASS score and outcomes at various points during hospitalization as well as following discharge. Using multivariable logistic regression analysis, we assessed the relationship between admission PASS score and risk of severe pancreatitis. PASS score performance was compared to established systems used to predict severe pancreatitis. Additional inpatient outcomes assessed included local complications, length of stay, development of systemic inflammatory response syndrome (SIRS), and intensive care unit (ICU) admission. We also assessed whether the PASS score at discharge was associated with early readmission (re-hospitalization for pancreatitis symptoms and complications within 30 days of discharge). A total of 439 patients were enrolled, their mean age was 42 (±15) years, and 53% were male. Admission PASS score >140 was associated with moderately severe and severe pancreatitis (OR 3.5 [95% CI 2.0, 6.3]), ICU admission (OR 4.9 [2.5, 9.4]), local complications (3.0 [1.6, 5.7]), and development of SIRS (OR 2.9 [1

  19. Could home sexually transmitted infection specimen collection with e-prescription be a cost-effective strategy for clinical trials and clinical care?

    Science.gov (United States)

    Blake, Diane R; Spielberg, Freya; Levy, Vivian; Lensing, Shelly; Wolff, Peter A; Venkatasubramanian, Lalitha; Acevedo, Nincoshka; Padian, Nancy; Chattopadhyay, Ishita; Gaydos, Charlotte A

    2015-01-01

    Results of a recent demonstration project evaluating feasibility, acceptability, and cost of a Web-based sexually transmitted infection (STI) testing and e-prescription treatment program (eSTI) suggest that this approach could be a feasible alternative to clinic-based testing and treatment, but the results need to be confirmed by a randomized comparative effectiveness trial. We modeled a decision tree comparing (1) cost of eSTI screening using a home collection kit and an e-prescription for uncomplicated treatment versus (2) hypothetical costs derived from the literature for referral to standard clinic-based STI screening and treatment. Primary outcome was number of STIs detected. Analyses were conducted from the clinical trial perspective and the health care system perspective. The eSTI strategy detected 75 infections, and the clinic referral strategy detected 45 infections. Total cost of eSTI was $94,938 ($1266/STI detected) from the clinical trial perspective and $96,088 ($1281/STI detected) from the health care system perspective. Total cost of clinic referral was $87,367 ($1941/STI detected) from the clinical trial perspective and $71,668 ($1593/STI detected) from the health care system perspective. Results indicate that eSTI will likely be more cost-effective (lower cost/STI detected) than clinic-based STI screening, both in the context of clinical trials and in routine clinical care. Although our results are promising, they are based on a demonstration project and estimates from other small studies. A comparative effectiveness research trial is needed to determine actual cost and impact of the eSTI system on identification and treatment of new infections and prevention of their sequelae.

  20. International, Multicenter Standardization of Acute Graft-versus-Host Disease Clinical Data Collection: A Report from the Mount Sinai Acute GVHD International Consortium.

    Science.gov (United States)

    Harris, Andrew C; Young, Rachel; Devine, Steven; Hogan, William J; Ayuk, Francis; Bunworasate, Udomsak; Chanswangphuwana, Chantiya; Efebera, Yvonne A; Holler, Ernst; Litzow, Mark; Ordemann, Rainer; Qayed, Muna; Renteria, Anne S; Reshef, Ran; Wölfl, Matthias; Chen, Yi-Bin; Goldstein, Steven; Jagasia, Madan; Locatelli, Franco; Mielke, Stephan; Porter, David; Schechter, Tal; Shekhovtsova, Zhanna; Ferrara, James L M; Levine, John E

    2016-01-01

    Acute graft-versus-host disease (GVHD) remains a leading cause of morbidity and nonrelapse mortality after allogeneic hematopoietic cell transplantation. The clinical staging of GVHD varies greatly between transplant centers and is frequently not agreed on by independent reviewers. The lack of standardized approaches to handle common sources of discrepancy in GVHD grading likely contributes to why promising GVHD treatments reported from single centers have failed to show benefit in randomized multicenter clinical trials. We developed guidelines through international expert consensus opinion to standardize the diagnosis and clinical staging of GVHD for use in a large international GVHD research consortium. During the first year of use, the guidance followed discussion of complex clinical phenotypes by experienced transplant physicians and data managers. These guidelines increase the uniformity of GVHD symptom capture, which may improve the reproducibility of GVHD clinical trials after further prospective validation. Copyright © 2016 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

  1. Self-perceived assessment skill of prospective physics teachers

    Science.gov (United States)

    Efendi, R.; Rustaman, N. Y.; Kaniawati, I.

    2018-05-01

    Assessment skills are an important component of assessment practice, without adequate assessment skills it is unlikely that teacher assessment practices will produce desired student learning outcomes. This study was conducted to reveal self-perceived assessment skills of prospective physics teachers by using quantitative descriptive analysis, and involving 92 prospective physics teachers who were experiencing teaching practice in junior high school and final project related to assessment. Data was collected by using Self-Perceived Assessment Science Skills Questionnaire consisted of 29 items related seven assessment competencies was developed and used in the study. Internal consistency reliability coefficient for the total scale scores was 0.87 as measured by Cronbach’s alpha. Determination of self-perceived assessment science skills detected from prospective physics teachers was carried out in descriptive statistics, in the form of respondent average values. Research findings show that self-perceived assessment skills of prospective physics teachers was categorized as transition.

  2. An Examination of Understandings of Prospective Teachers about Science and Science History

    Science.gov (United States)

    Yildiz, Cemalettin

    2018-01-01

    The purpose of this study was to reveal beliefs of prospective teachers about "science" and "science history." The qualitative research approach was employed in the study. The study group consisted of 150 prospective teachers. A form developed by the researcher was used for data collection. The form consisted of open-ended…

  3. Can a barcode scanner for blood collection improve patient identification integrity in the emergency department? A prospective before-and-after study.

    Science.gov (United States)

    Spain, David; Crilly, Julia; Pierce, John; Steele, Michael; Scuffham, Paul; Keijzers, Gerben

    2015-02-01

    To describe the effect of interventions designed to improve patient identification (PI) during pathology collection in the ED. A prospective before-and-after intervention study was conducted between June 2009 and June 2010 in a regional ED in Queensland, Australia. Interventions aimed to improve PI and specimen labelling, and consisted of: (i) education alone; and (ii) education plus an armband scanner that voice-prompted collector behaviour. Main outcomes measured included: frequency of correct key behaviours (KBs) during specimen collection, pathology integrity errors and cost of interventions. Data from 282 ED pathology collections were analysed (before: n = 115, after with education: n = 95, after with education plus armband scanner: n = 72). KBs for PI and labelling improved significantly following education plus armband scanner use. Application of armbands before sample collection increased (36% vs 90%, P patient to state their name (25% vs 93%, P patient misidentification was detected in this small study. The annual costs for a hospital to adopt the education programme with and without the armband scanner were $104,045 and $5330 respectively. ED staff had poor behaviours for identifying patients and labelling pathology specimens before intervention. These safety behaviours were considered an assumed skill. Education alone improved critical KBs markedly that was further augmented by the armband scanner. The cost to adopt education alone is relatively low compared to the addition of armband scanner technology. © 2015 The Authors. Emergency Medicine Australasia published by Wiley Publishing Asia Pty Ltd on behalf of Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  4. Prospective assessment of clinical symptoms associated with enterovirus and parechovirus genotypes in a multicenter study in Dutch children.

    Science.gov (United States)

    de Crom, S C M; Rossen, J W A; de Moor, R A; Veldkamp, E J M; van Furth, A M; Obihara, C C

    2016-04-01

    Human non-polio enterovirus (EV) and human parechovirus (HPeV) are important pathogens of viral infection and aseptic meningitis in children. The aim of this study is to prospectively compare the incidence, clinical signs, blood and cerebrospinal fluid in EV and HPeV infected children. To compare the clinical symptoms and laboratory data of children with different EV and HPeV genotypes. This study is part of a multicenter prospective cohort study. Children were included in 3 different hospitals in The Netherlands from 2008 to 2011. Of 285 included patients, 140 (49%) had EV and 44 (15%) HPeV infection. Of children with EV infection 9 (6%) had EV-A, 109 (78%) EV-B, 12 (9%) had a non-type able EV and in 10 (7%) no genotyping was performed. Of children with HPeV infection, 24 (55%) had HPeV-3, 6 (14%) HPeV-1, 2 (5%) HPeV-4 and 1 (2%) HPeV-6. Meningitis was more frequent in EV than in HPeV infected children (54% vs. 36%, p=0.046), and in EV-B than EV-A infected children (60 vs. 33%). In contrast gastroenteritis was more frequent in HPeV than EV infected children (30% vs. 15%, p=0.030), and significantly more in HPeV-1 than HPeV-3 infected children (p<0.001). EV infection is more often associated with meningitis and HPeV infection more often with a gastro-enteritis. EV genotype B infection is more often associated with meningitis than EV genotype A infection. HPeV-1 infection was more often associated with gastroenteritis than HPeV-3 infection. Copyright © 2016 Elsevier B.V. All rights reserved.

  5. Changes and Clinical Consequences of Smoking Cessation in Patients With COPD: A Prospective Analysis From the CHAIN Cohort.

    Science.gov (United States)

    Martínez-González, Cristina; Casanova, Ciro; de-Torres, Juan P; Marín, José M; de Lucas, Pilar; Fuster, Antonia; Cosío, Borja G; Calle, Myriam; Peces-Barba, Germán; Solanes, Ingrid; Agüero, Ramón; Feu-Collado, Nuria; Alfageme, Inmaculada; Romero Plaza, Amparo; Balcells, Eva; de Diego, Alfredo; Marín Royo, Margarita; Moreno, Amalia; Llunell Casanovas, Antonia; Galdiz, Juan B; Golpe, Rafael; Lacárcel Bautista, Celia; Cabrera, Carlos; Marin, Alicia; Soriano, Joan B; Lopez-Campos, Jose Luis

    2018-02-22

    Despite the existing evidence-based smoking cessation interventions, chances of achieving that goal in real life are still low among patients with COPD. We sought to evaluate the clinical consequences of changes in smoking habits in a large cohort of patients with COPD. CHAIN (COPD History Assessment in Spain) is a Spanish multicenter study carried out at pulmonary clinics including active and former smokers with COPD. Smoking status was certified by clinical history and co-oximetry. Clinical presentation and disease impact were recorded via validated questionnaires, including the London Chest Activity of Daily Living (LCADL) and the Hospital Anxiety and Depression Scale (HADS). No specific smoking cessation intervention was carried out. Factors associated with and clinical consequences of smoking cessation were analyzed by multivariate regression and decision tree analyses. One thousand and eighty-one patients with COPD were included (male, 80.8%; age, 65.2 [SD 8.9] years; FEV 1 , 60.2 [20.5]%). During the 2-year follow-up time (visit 2, 906 patients; visit 3, 791 patients), the majority of patients maintained the same smoking habit. Decision tree analysis detected chronic expectoration as the most relevant variable to identify persistent quitters in the future, followed by an LCADL questionnaire (cutoff 9 points). Total anxiety HADS score was the most relevant clinical impact associated with giving up tobacco, followed by the LCADL questionnaire with a cutoff value of 10 points. In this real-life prospective COPD cohort with no specific antismoking intervention, the majority of patients did not change their smoking status. Our study also identifies baseline expectoration, anxiety, and dyspnea with daily activities as the major determinants of smoking status in COPD. ClinicalTrials.gov; No. NCT01122758; URL: www.clinicaltrials.gov. Copyright © 2018 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

  6. Clinical presentation of late haemorrhagic disease of newborn

    International Nuclear Information System (INIS)

    Majeed, R.; Memon, Y.; Majeed, F.

    2008-01-01

    To observe the clinical presentation of late haemorrhagic disease of the newborn (LHDNB), and clinical improvement after the administration of vitamin K/sub 1/. This is a prospective descriptive study. All the children older than seven days who presented with bleeding were admitted in pediatrics ward of Isra University Hyderabad from April 2006 to April 2007 were included. Data collection was done by means of detailed proforma. Analysis was done on SPSS version 11. Thirty five cases were included. Commonest site of bleeding was subcutaneous followed by oral and injection site. Mean age of late haemorrhagic disease of newborn was 109 days and minimum age of presentation was 28 days. Common clinical presentations were irritability, convulsions, poor reflexes and poor feeding. Mostly recovery was within 24 hours after vit K. Late HDN results in severe hemorrhage especially hemorrhage in the central nervous system. Administration of Vitamin K (1mg, 1M) at birth can present these severe complications. (author)

  7. Treatment of mandibular angle fracture with a 2mm, 3 dimensional rectangular grid compression miniplates: A prospective clinical study.

    Science.gov (United States)

    Mansuri, Samir; Abdulkhayum, Abdul Mujeeb; Gazal, Giath; Hussain, Mohammed Abid Zahir

    2013-12-01

    Surgical treatment of fracture mandible using an internal fixation has changed in the last decades to achieve the required rigidity, stability and immediate restoration of function. The aim of the study was to do a Prospective study of 10 patients to determine the efficacy of rectangular grid compression miniplates in mandibular fractures. This study was carried out using 2.0 rectangular grid compression miniplates and 8 mm multidirectional screws as a rigid internal fixation in 10 patients without post operative intermaxillary fixation (IMF). Follow up was done for period of 6 months. All fractures were healed with an absolute stability in post operative period. None of the patient complained of post operative difficulty in occlusion. Within the limits of this study, it can be concluded that rectangular grid compression miniplates was rigid, reliable and thus can be recommended for the treatment of mandibular angle fractures. How to cite this article: Mansuri S, Abdulkhayum AM, Gazal G, Hussain MA. Treatment of mandibular angle fracture with a 2mm, 3 dimensional rectangular grid compression miniplates: A prospective clinical study. J Int Oral Health 2013;5(6):93-100 .

  8. Pattern recognition applied to uranium prospecting

    Energy Technology Data Exchange (ETDEWEB)

    Briggs, P L; Press, F [Massachusetts Inst. of Tech., Cambridge (USA). Dept. of Earth and Planetary Sciences

    1977-07-14

    It is stated that pattern recognition techniques provide one way of combining quantitative and descriptive geological data for mineral prospecting. A quantified decision process using computer-selected patterns of geological data has the potential for selecting areas with undiscovered deposits of uranium or other minerals. When a natural resource is mined more rapidly than it is discovered, its continued production becomes increasingly difficult, and it has been noted that, although a considerable uranium reserve may remain in the U.S.A., the discovery rate for uranium is decreasing exponentially with cumulative exploration footage drilled. Pattern recognition methods of organising geological information for prospecting may provide new predictive power, as well as insight into the occurrence of uranium ore deposits. Often the task of prospecting consists of three stages of information processing: (1) collection of data on known ore deposits; (2) noting any regularities common to the known examples of an ore; (3) selection of new exploration targets based on the results of the second stage. A logical pattern recognition algorithm is here described that implements this geological procedure to demonstrate the possibility of building a quantified uranium prospecting guide from diverse geologic data.

  9. Implementation and evaluation of Parkinson disease management in an outpatient clinical pharmacist-run neurology telephone clinic.

    Science.gov (United States)

    Stefan, Teodora Cristina; Elharar, Nicole; Garcia, Guadalupe

    2018-05-01

    Parkinson disease (PD) is a progressive, debilitating neurodegenerative disease that often requires complex pharmacologic treatment regimens. Prior to this clinic, there was no involvement of a clinical pharmacy specialist (CPS) in the outpatient neurology clinic at the West Palm Beach Veterans Affairs Medical Center. This was a prospective, quality-improvement project to develop a clinical pharmacist-run neurology telephone clinic and evaluate pharmacologic and nonpharmacologic interventions in an effort to improve the quality of care for patients with PD. Additionally, the CPS conducted medication education groups to 24 patients with PD and their caregivers, if applicable, at this medical center with the purpose of promoting patient knowledge and medication awareness. Medication management was performed via telephone rather than face to face. Only patients with a concomitant mental health diagnosis for which they were receiving at least one psychotropic medication were included for individual visits due to the established scope of practice of the CPS being limited to mental health and primary care medications. Data collection included patient and clinic demographics as well as pharmacologic and nonpharmacologic interventions made for patients enrolled from January 6, 2017, through March 31, 2017. A total of 49 pharmacologic and nonpharmacologic interventions were made for 10 patients. We successfully implemented and evaluated a clinical pharmacist-run neurology telephone clinic for patients with PD. Expansion of this clinic to patients with various neurological disorders may improve access to care using an innovative method of medication management expertise by a CPS.

  10. Clinical outcome of pneumatic dilatation in patients with achalasia cardia: A single-center prospective study

    Directory of Open Access Journals (Sweden)

    Amit Hanmant Shejal

    2017-01-01

    Full Text Available Background and Aim: Pneumatic balloon dilation is one of the most commonly used and effective methods for treating patients with achalasia cardia. This study was performed to assess immediate and long-term response of pneumatic dilatation (PD in these patients. Materials and Methods: Forty-four achalasia cardia patients, who underwent PD in our center from January 2013 to December 2015, were prospectively studied. Data from these patients were analyzed for clinical improvement in symptoms after dilatation procedure over this period as per Eckardt score. Patients who required repeated procedure and factors influencing remission of symptoms were analyzed. Results: A total of 44 patients underwent PD, among which three lost to follow up. Of the 41 patients, 21 were male (51.22% and 20 were females (48.78%. Mean age was 38.68 (13–64 years. Median symptom duration before first dilatation was 18 months (2–240. Major symptoms at presentation were dysphagia (n = 41, 100%, regurgitation (n = 38 92.68%, chest pain (n = 31, 75.6%, and weight loss (n = 20, 48.78%. Mean follow-up period was 22.22 months (9–38. Forty (97.56% patients had immediate clinical improvement after 1 dilatation, of which 38 (92.68% patients did not require any further treatment. Mean Eckardt score was 6.82 (4–11 at the time of first dilatation which improved to 0.66 during follow-up. Two patients required second dilatation (one 5 months and other 18 months after the first procedure. Conclusion: PD is a safe and effective long-term therapy for achalasia cardia and has a good long-term clinical remission.

  11. Gender differences in prospective teachers’ mathematical literacy: problem solving of occupational context on shipping company

    Science.gov (United States)

    Lestari, N. D. S.; Juniati, D.; Suwarsono, St.

    2018-04-01

    The purpose of this paper is to describe to what extent the prospective teachers can be considered as mathematically literate and how they communicate their reasoning in solving the problem based on the sex differences. Data were collected through mathematics literacy test on occupational context by 157 of prospective teachers from three universities in East Java, Indonesia. Their written responses were collected, organized based on the sex differences, analyzed and categorized to one of three levels of mathematical literacy. The examples of interesting students’ response altogether with the scoring are discussed to describe their characteristic on mathematical literacy and their communication. The result showed that in general the mathematical literacy of female prospective teachers tend to be better than male prospective math teachers. Female prospective teachers are more capable of logical reasoning, using concepts, facts and procedures and algebraic operations to draw conclusions; make an interpretations and evaluations. This study has an implication that gender differences in mathematical literacy of prospective math teachers do exist, therefore this issue should be given a serious concern from the development programs of the faculty.

  12. Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy.

    Science.gov (United States)

    Messer, Jamie C; Punnen, Sanoj; Fitzgerald, John; Svatek, Robert; Parekh, Dipen J

    2014-12-01

    To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion. This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL. At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months. There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts. © 2014 The Authors. BJU International © 2014 BJU International.

  13. Age-related prevalence of diabetes mellitus, cardiovascular disease and anticoagulation therapy use in a urolithiasis population and their effect on outcomes: the Clinical Research Office of the Endourological Society Ureteroscopy Global Study

    NARCIS (Netherlands)

    Daels, F. Pedro J.; Gaizauskas, Andrius; Rioja, Jorge; Varshney, Anil K.; Erkan, Erkan; Ozgok, Yasar; Melekos, Michael; de La Rosette, Jean J. M. C. H.

    2015-01-01

    This study examined the prevalence of risk factors for urological stone surgery and their possible influence on outcome and complications following ureteroscopy (URS). The Clinical Research Office of the Endourological Society Ureteroscopy Global Study collected prospective data on consecutive

  14. Heterogeneity of Monosymptomatic Resting Tremor in a Prospective Study: Clinical Features, Electrophysiological Test, and Dopamine Transporter Positron Emission Tomography.

    Science.gov (United States)

    Zheng, Hua-Guang; Zhang, Rong; Li, Xin; Li, Fang-Fei; Wang, Ya-Chen; Wang, Xue-Mei; Lu, Ling-Long; Feng, Tao

    2015-07-05

    The relationship between monosymptomatic resting tremor (mRT) and Parkinson's disease (PD) remains controversial. In this study, we aimed to assess the function of presynaptic dopaminergic neurons in patients with mRT by dopamine transporter positron emission tomography (DAT-PET) and to evaluate the utility of clinical features or electrophysiological studies in differential diagnosis. Thirty-three consecutive patients with mRT were enrolled prospectively. The Unified Parkinson's Disease Rating Scale and electromyography were tested before DAT-PET. Striatal asymmetry index (SAI) was calculated, and a normal DAT-PET was defined as a SAI of hygiene score, walking in motor experiences of daily living (Part II) and motor examination (Part III) were significant different between two groups (P postural tremor tend to be higher in the SWEDDs group (P = 0.08 and P = 0.05, respectively). mRT is heterogeneous in presynaptic nigrostriatal dopaminergic degeneration, which can be determined by DAT-PET brain imaging. Clinical and electrophysiological features may provide clues to distinguish PD from SWEDDs.

  15. An Internet-ready database for prospective randomized clinical trials of high-dose-rate brachytherapy for adenocarcinoma of the prostate

    International Nuclear Information System (INIS)

    Devlin, Phillip M.; Brus, Christina R.; Kazakin, Julia; Mitchell, Ronald B.; Demanes, D. Jeffrey; Edmundson, Gregory; Gribble, Michael; Gustafson, Gary S.; Kelly, Douglas A.; Linares, Luis A.; Martinez, Alvaro A.; Mate, Timothy P.; Nag, Subir; Perez, Carlos A.; Rao, Jaynath G.; Rodriguez, Rodney R.; Shasha, Daniel; Tripuraneni, Prabhakar

    2002-01-01

    Purpose: To demonstrate a new interactive Internet-ready database for prospective clinical trials in high-dose-rate (HDR) brachytherapy for prostate cancer. Methods and Materials: An Internet-ready database was created that allows common data acquisition and statistical analysis. Patient anonymity and confidentiality are preserved. These data forms include all common elements found from a survey of the databases. The forms allow the user to view patient data in a view-only or edit mode. Eight linked forms document patient data before and after receiving HDR therapy. The pretreatment forms are divided into four categories: staging, comorbid diseases, external beam radiotherapy data, and signs and symptoms. The posttreatment forms separate data by HDR implant information, HDR medications, posttreatment signs and symptoms, and follow-up data. The forms were tested for clinical usefulness. Conclusion: This Internet-based database enables the user to record and later analyze all relevant medical data and may become a reliable instrument for the follow-up of patients and evaluation of treatment results

  16. Prospective memory, level of disability, and return to work in severe mental illness.

    Science.gov (United States)

    Burton, Cynthia Z; Vella, Lea; Twamley, Elizabeth W

    2018-02-25

    Prospective memory (the ability to remember to do things) has clear implications for everyday functioning, including employment, in people with severe mental illnesses (SMI). This study aimed to evaluate prospective memory performance and its relationship to real-world functional variables in an employment-seeking sample of people with SMI (Clinical Trial registration number NCT00895258). 153 individuals with DSM-IV diagnosis of depression (n = 58), bipolar disorder (n = 37), or schizophrenia (n = 58) who were receiving outpatient psychiatric care at a university clinic enrolled in a trial of supported employment and completed a baseline assessment. Prospective memory was measured with the Memory for Intentions Test (MIST); real-world functional status included work history variables, clinical history variables, baseline functional capacity (UCSD Performance-based Skills Assessment-Brief), and work outcomes (weeks worked and wages earned during two years of supported employment). Participants with schizophrenia performed worse on the MIST than did those with affective disorders. Independent of diagnosis, education, and estimated intellectual functioning, prospective memory significantly predicted variance in measures of disability and illness burden (disability benefits, hospitalization history, current functional capacity), and work outcomes over two years of supported employment (weeks worked). Worse prospective memory appears to be associated with greater illness burden and functional disability in SMI. Mental health clinicians and employment specialists may counsel clients to use compensatory prospective memory strategies to improve work performance and decrease functional disability associated with SMI.

  17. 21 CFR 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct...

    Science.gov (United States)

    2010-04-01

    ... minimal risk but presenting the prospect of direct benefit to individual subjects. 50.52 Section 50.52... investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual... prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to...

  18. Clinical and virological factors associated with gastrointestinal symptoms in patients with acute respiratory infection: a two-year prospective study in general practice medicine.

    Science.gov (United States)

    Minodier, Laetitia; Masse, Shirley; Capai, Lisandru; Blanchon, Thierry; Ceccaldi, Pierre-Emmanuel; van der Werf, Sylvie; Hanslik, Thomas; Charrel, Remi; Falchi, Alessandra

    2017-11-22

    Gastrointestinal (GI) symptoms, such as diarrhea, vomiting, abdominal pain and nausea are not an uncommon manifestation of an acute respiratory infection (ARI). We therefore evaluated clinical and microbiological factors associated with the presence of GI symptoms in patients consulting a general practitioner (GP) for ARI. Nasopharyngeal swabs, stool specimens and clinical data from patients presenting to GPs with an ARI were prospectively collected during two winter seasons (2014-2016). Samples were tested by quantitative real-time PCR for 12 respiratory pathogen groups and for 12 enteric pathogens. Two hundred and four of 331 included patients (61.6%) were positive for at least one respiratory pathogen. Sixty-nine stools (20.8%) were positive for at least one pathogen (respiratory and/or enteric). GI symptoms were more likely declared in case of laboratory confirmed-enteric infection (adjusted odds ratio (aOR) = 3.2; 95% confidence interval [CI] [1.2-9.9]; p = 0.02) or human coronavirus (HCoV) infection (aOR = 2.7; [1.2-6.8]; p = 0.02). Consumption of antipyretic medication before the consultation seemed to reduce the risk of developing GI symptoms for patients with laboratory-confirmed influenza (aOR = 0.3; [0.1-0.6]; p = 0.002). The presence of GI symptoms in ARI patients could not be explained by the detection of respiratory pathogens in stools. However, the detection of enteric pathogens in stool samples could explained by the presence of GI symptoms in some of ARI cases. The biological mechanisms explaining the association between the presence of HCoVs in nasopharynx and GI symptoms need to be explored.

  19. Dehydration in children with diabetic ketoacidosis: a prospective study.

    Science.gov (United States)

    Sottosanti, Maria; Morrison, Gavin C; Singh, Ram N; Sharma, Ajay P; Fraser, Douglas D; Alawi, Khalid; Seabrook, Jamie A; Kornecki, Alik

    2012-02-01

    To investigate the association between the degree of patient dehydration on presentation with diabetic ketoacidosis (DKA) and clinical and laboratory parameters obtained on admission. Prospective descriptive study. A tertiary care children's hospital. Thirty-nine paediatric patients (1 month-16 years) presenting with 42 episodes of DKA. Clinical and biochemical variables were collected on admission. Dehydration was calculated by measuring acute changes in body weight during the period of illness. All patients were treated according to a previously established protocol. Magnitude of dehydration, defined as % loss of body weight (LBW), was determined by the difference in body weight obtained at presentation and at discharge. The relationship between the magnitude of dehydration and the clinical assessment and biochemical parameters was examined. The median (25th-75th centiles) magnitude of dehydration at presentation was 5.7% (3.8-8.3%) (mean ± SD 6.8 ± 5%). Neither the initial clinical assessment nor the comprehensive biochemical profile at admission correlated with the magnitude of dehydration. Despite considerable variation in the degree of dehydration and biochemical disequilibrium, all patients recovered from DKA within 24 h with a standardised therapeutic approach. Furthermore, the rapidity of patient recovery did not correlate with the magnitude of dehydration on presentation or the amount of fluid administered (median (25th-75th centiles) 48.8 ml/kg (38.5-60.3)) in the first 12 h. The magnitude of dehydration in DKA is not reflected by either clinical or biochemical parameters. These findings need confirmation in larger studies.

  20. Clinical course and prognosis of musculoskeletal pain in patients referred for physiotherapy

    DEFF Research Database (Denmark)

    de Vos Andersen, Nils-Bo; Kent, Peter; Hjort, Jakob

    2017-01-01

    BACKGROUND: Danish patients with musculoskeletal disorders are commonly referred for primary care physiotherapy treatment but little is known about their general health status, pain diagnoses, clinical course and prognosis. The objectives of this study were to 1) describe the clinical course...... of patients with musculoskeletal disorders referred to physiotherapy, 2) identify predictors associated with a satisfactory outcome, and 3) determine the influence of the primary pain site diagnosis relative to those predictors. METHODS: This was a prospective cohort study of patients (n = 2,706) newly...... referred because of musculoskeletal pain to 30 physiotherapy practices from January 2012 to May 2012. Data were collected via a web-based questionnaire 1-2 days prior to the first physiotherapy consultation and at 6 weeks, 3 and 6 months, from clinical records (including primary musculoskeletal symptom...

  1. The Clinical Research Office of the Endourological Society Ureteroscopy Global Study: Indications, Complications, and Outcomes in 11885 Patients

    DEFF Research Database (Denmark)

    De La Rosette, Jean; Denstedt, John D; Geavlete, Petrisor A

    2013-01-01

    Purpose: To assess the current indications for ureteroscopy (URS) treatment, outcome in terms of stone-free rate, and intra- and postoperative complications using the modified Clavien grading system. Patients and Methods: The Clinical Research Office of the Endourological Society (CROES) collected...... prospective data as part of the URS Global Study for consecutive patients treated with URS at centers around the world for 1 year. URS was performed according to study protocol and local clinical practice guidelines. Stone size and location were recorded and postoperative outcome and complications, graded...

  2. 78 FR 35287 - Agency Information Collection Activities; Proposed Collection; Public Comment Request

    Science.gov (United States)

    2013-06-12

    .... Information Collection Request Title: Black Lung Clinics Program Performance Measures OMB No. 0915-0292..., conducts an annual data collection of user information for the Black Lung Program, which has been ongoing, with OMB, approval since 2004. The purpose of the Black Lung Clinic Program is to improve the health...

  3. Neoplastic Meningitis from Solid Tumors: A Prospective Clinical Study in Lombardia and a Literature Review on Therapeutic Approaches

    Directory of Open Access Journals (Sweden)

    A. Silvani

    2013-01-01

    Full Text Available Neoplastic dissemination to the leptomeninges is an increasingly common occurrence in patients with both haematological and solid tumors arising outside the central nervous system. Both refinement of diagnostic techniques (Magnetic resonance imaging and increased survival in patients treated with targeted therapies for systemic tumors account for this increased frequency. Cerebrospinal fluid cytological analysis and MRI confirm clinical diagnosis based on multifocal central nervous system signs/symptoms in a patient with known malignancy. Overall survival in patients with leptomeningeal neoplastic dissemination from solid tumors is short, rarely exceeding 3-4 months. However, selected patients may benefit from aggressive therapies, Apart from symptomatic treatment, intrathecal chemotherapy is used, with both free (methotrexate, Thiotepa, AraC and liposomal antitumor agents (liposomal AraC. Palliative radiotherapy is indicated only in cases of symptomatic bulky disease, surgery is limited to positioning of Ommaya recervoirs or C5F shunting. We report clinical data on a cohort of 26 prospectively followed patients with neoplastic leptomeningitis followed in Lombardia, Italy, in 2011. Prognostic factors and pattern of care are reported.

  4. A prospective development study of software-guided radio-frequency ablation of primary and secondary liver tumors: Clinical intervention modelling, planning and proof for ablation cancer treatment (ClinicIMPPACT).

    Science.gov (United States)

    Reinhardt, Martin; Brandmaier, Philipp; Seider, Daniel; Kolesnik, Marina; Jenniskens, Sjoerd; Sequeiros, Roberto Blanco; Eibisberger, Martin; Voglreiter, Philip; Flanagan, Ronan; Mariappan, Panchatcharam; Busse, Harald; Moche, Michael

    2017-12-01

    Radio-frequency ablation (RFA) is a promising minimal-invasive treatment option for early liver cancer, however monitoring or predicting the size of the resulting tissue necrosis during the RFA-procedure is a challenging task, potentially resulting in a significant rate of under- or over treatments. Currently there is no reliable lesion size prediction method commercially available. ClinicIMPPACT is designed as multicenter-, prospective-, non-randomized clinical trial to evaluate the accuracy and efficiency of innovative planning and simulation software. 60 patients with early liver cancer will be included at four European clinical institutions and treated with the same RFA system. The preinterventional imaging datasets will be used for computational planning of the RFA treatment. All ablations will be simulated simultaneously to the actual RFA procedure, using the software environment developed in this project. The primary outcome measure is the comparison of the simulated ablation zones with the true lesions shown in follow-up imaging after one month, to assess accuracy of the lesion prediction. This unique multicenter clinical trial aims at the clinical integration of a dedicated software solution to accurately predict lesion size and shape after radiofrequency ablation of liver tumors. Accelerated and optimized workflow integration, and real-time intraoperative image processing, as well as inclusion of patient specific information, e.g. organ perfusion and registration of the real RFA needle position might make the introduced software a powerful tool for interventional radiologists to optimize patient outcomes.

  5. Prospective Teachers' Likelihood of Performing Unethical Behaviors in the Real and Virtual Environments

    Science.gov (United States)

    Akdemir, Ömür; Vural, Ömer F.; Çolakoglu, Özgür M.

    2015-01-01

    Individuals act different in virtual environment than real life. The primary purpose of this study is to investigate the prospective teachers' likelihood of performing unethical behaviors in the real and virtual environments. Prospective teachers are surveyed online and their perceptions have been collected for various scenarios. Findings revealed…

  6. Challenges in collecting clinical samples for research from pregnant women of South Asian origin: evidence from a UK study.

    Science.gov (United States)

    Neelotpol, Sharmind; Hay, Alastair W M; Jolly, A Jim; Woolridge, Mike W

    2016-08-31

    To recruit South Asian pregnant women, living in the UK, into a clinicoepidemiological study for the collection of lifestyle survey data and antenatal blood and to retain the women for the later collection of cord blood and meconium samples from their babies for biochemical analysis. A longitudinal study recruiting pregnant women of South Asian and Caucasian origin living in the UK. Recruitment of the participants, collection of clinical samples and survey data took place at the 2 sites within a single UK Northern Hospital Trust. Pregnant women of South Asian origin (study group, n=98) and of Caucasian origin (comparison group, n=38) living in Leeds, UK. Among the participants approached, 81% agreed to take part in the study while a 'direct approach' method was followed. The retention rate of the participants was a remarkable 93.4%. The main challenges in recruiting the ethnic minority participants were their cultural and religious conservativeness, language barrier, lack of interest and feeling of extra 'stress' in taking part in research. The chief investigator developed an innovative participant retention method, associated with the women's cultural and religious practices. The method proved useful in retaining the participants for about 5 months and in enabling successful collection of clinical samples from the same mother-baby pairs. The collection of clinical samples and lifestyle data exceeded the calculated sample size required to give the study sufficient power. The numbers of samples obtained were: maternal blood (n=171), cord blood (n=38), meconium (n=176), lifestyle questionnaire data (n=136) and postnatal records (n=136). Recruitment and retention of participants, according to the calculated sample size, ensured sufficient power and success for a clinicoepidemiological study. Results suggest that development of trust and confidence between the participant and the researcher is the key to the success of a clinical and epidemiological study involving

  7. Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

    Science.gov (United States)

    De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

    2017-11-15

    Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

  8. The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS): a study protocol for a prospective longitudinal study.

    Science.gov (United States)

    Fagher, Kristina; Jacobsson, Jenny; Timpka, Toomas; Dahlström, Örjan; Lexell, Jan

    2016-01-01

    Paralympic sport provides sporting opportunities for athletes with a disability, with the Paralympic Games as the main event. Participation in sport is, however, associated with a significant risk for sustaining injuries and illnesses. Our knowledge of sports-related injuries and illnesses in Paralympic sport is very limited and there are no large-scale epidemiological cohort studies. The purpose here is to present a protocol for a prospective longitudinal study: The Sports-Related Injuries and Illnesses in Paralympic Sport Study (SRIIPSS). An argument-based method for investigation of design problems was used to structure the study protocol. The primary requirement of the protocol is to allow prospective studies over time and include exposure to both training and competition. To reflect the complexity of Paralympic sport with athletes' pre-existing impairments, use of assistive equipment, pain and other and medical issues, it is required that the data collection system is specifically adapted to Paralympic sport. To allow the collection of data, at the same time as there is limited access to coaches and medical personnel, it is advantageous that data can be collected online directly from the athletes. Based on this a self-report athlete monitoring system will be developed, where the athletes can enter data weekly via their mobile phones or lap-tops. Data will be collected from around 100 Swedish Paralympic athletes for approximately 1 year, which will allow us to i) prospectively estimate the annual incidence of sports-related injuries and illnesses and ii) explore risk factors and mechanisms for sustaining sports-related injuries and illnesses based on athlete exposure and training loads. For effective implementation of injury and illness prevention measures, comprehensive epidemiological knowledge is required. This study will be the first prospective longitudinal self-report study of sports-related injuries and illnesses in Paralympic sport over a longer period

  9. Pediatric supraglottic airway devices in clinical practice: A prospective observational study.

    Science.gov (United States)

    Kleine-Brueggeney, Maren; Gottfried, Anne; Nabecker, Sabine; Greif, Robert; Book, Malte; Theiler, Lorenz

    2017-09-02

    Supraglottic airway devices (SGA) are commonly used in pediatric anesthesia and serve as primary or back-up devices for difficult airway management. Most SGA are marketed without proper clinical evaluation. The purpose of this study was to evaluate the performance of the pediatric LMA Supreme™, Air-Q® and Ambu® Aura-i™. This prospective observational study was performed at Bern University Hospital, Switzerland. With ethics committee approval and a waiver for written informed consent 240 children undergoing elective surgery with an ASA class I-III and a weight of 5-30 kg were included. Three different pediatric supraglottic airway devices were assessed: The LMA Supreme™, Air-Q® and Ambu® Aura-i™. Primary outcome parameter was airway leak pressure. Secondary outcome parameters included first attempt and overall success rate, insertion time, fiberoptic view through the SGA, and adverse events. The primary hypothesis was that the mean airway leak pressure of each tested SGA was 20 cmH 2 O ± 10%. None of the SGA showed a mean airway leak pressure of 20 cmH 2 O ± 10%, but mean airway leak pressures differed significantly between devices [LMA Supreme™ 18.0 (3.4) cmH 2 O, Air-Q® 15.9 (3.2) cmH 2 O, Ambu® Aura-i™ 17.3 (3.7) cmH 2 O, p < 0.001]. First attempt success rates (LMA Supreme™ 100%, Air-Q® 90%, Ambu® Aura-i™ 91%, p = 0.02) and overall success rates (LMA Supreme™ 100%, Air-Q® 91%, Ambu® Aura-i™ 95%, p = 0.02) also differed significantly. Insertion times ranged from 20 (7) seconds (Air-Q®) to 24 (6) seconds (LMA Supreme™,

  10. Investigation of Prospective Primary Mathematics Teachers' Perceptions and Images for Quadrilaterals

    Science.gov (United States)

    Turnuklu, Elif; Gundogdu Alayli, Funda; Akkas, Elif Nur

    2013-01-01

    The object of this study was to show how prospective elementary mathematics teachers define and classify the quadrilaterals and to find out their images. This research was a qualitative study. It was conducted with 36 prospective elementary mathematics teachers studying at 3rd and 4th years in an educational faculty. The data were collected by…

  11. Concordance between DSM-IV and DSM-5 criteria for delirium diagnosis in a pooled database of 768 prospectively evaluated patients using the delirium rating scale-revised-98

    OpenAIRE

    Meagher, David J; Morandi, Alessandro; Inouye, Sharon K; Ely, Wes; Adamis, Dimitrios; Maclullich, Alasdair J; Rudolph, James L; Neufeld, Karin; Leonard, Maeve; Bellelli, Giuseppe; Davis, Daniel; Teodorczuk, Andrew; Kriesel, Stefan; Thomas, Christine; Hasemann, Wolfgang

    2014-01-01

    peer-reviewed Background: The Diagnostic and Statistical Manual fifth edition (DSM-5) provides new criteria for delirium diagnosis. We examined delirium diagnosis using these new criteria compared with the Diagnostic and Statistical Manual fourth edition (DSM-IV) in a large dataset of patients assessed for delirium and related presentations. Methods: Patient data (n = 768) from six prospectively collected cohorts, clinically assessed using DSM-IV and the Delirium Rating Scale-R...

  12. Self-Reported Adverse Drug Reactions, Medication Adherence, and Clinical Outcomes among Major Depressive Disorder Patients in Ethiopia: A Prospective Hospital Based Study

    Directory of Open Access Journals (Sweden)

    Tadesse Melaku Abegaz

    2017-01-01

    Full Text Available Background. There is paucity of data on prevalence of Adverse Drug Reactions (ADRs and adherence and clinical outcomes of antidepressants. The present study determined the magnitude of ADRs of antidepressants and their impact on the level of adherence and clinical outcome. Methods. A prospective cross-sectional study was conducted among depression patients from September 2016 to January 2017 at Gondar University Hospital psychiatry clinic. The Naranjo ADR probability scale was employed to assess the ADRs. The rate of medication adherence was determined using Morisky Medication Adherence Measurement Scale-Eight. Results. Two hundred seventeen patients participated in the study, more than half of them being males (122; 56.2%. More than one-half of the subjects had low adherence to their medications (124; 57.1% and about 186 (85.7% of the patients encountered ADR. The most common ADR was weight gain (29; 13.2%. More than one-half (125; 57.6% of the respondents showed improved clinical outcome. Optimal level of medication adherence decreased the likelihood of poor clinical outcome by 56.8%. Conclusion. ADRs were more prevalent. However, adherence to medications was very poor in the setup. Long duration of depression negatively affects the rate of adherence. In addition, adherence was found to influence the clinical outcome of depression patients.

  13. Antibiotics in periodontal surgeries: A prospective randomised cross over clinical trial

    Directory of Open Access Journals (Sweden)

    Sheetal Oswal

    2014-01-01

    Full Text Available Aims and Objectives: (1 To evaluate the need of antibiotics in periodontal surgeries in reducing postsurgical infections and explore if antibiotics have any key role in reducing or eliminating inflammatory complications. (2 To establish the incidence of postoperative infections in relation to type of surgery and determine those factors, which may affect infection rates. Materials and Methods: A prospective randomized double-blind cross over clinical study was carried out for a period of 1-year with predefined inclusion and exclusion criteria. All the patients included in the study for any periodontal surgery were randomly divided into three categories: Group A (prophylactic, Group B (therapeutic, and Group C (no antibiotics. Patients were followed up for 1-week after surgery on the day of suture removal and were evaluated for pain, swelling, fever, infection, delayed wound healing and any other significant findings. Appropriate statistical analysis was carried out to evaluate the objectives and P < 0.05 was considered as statistically significant. Results: No infection was reported in any of 90 sites. Patients reported less pain and postoperative discomfort when prophylactic antibiotics were given. However, there were no statistical significant differences between the three groups. Summary and Conclusion: There was no postoperative infection reported in all the 90 sites operated in this study. The prevalence of postoperative infections following periodontal surgery is <1% and this low risk does not justify the routine use of systemic antimicrobials just to prevent infections. Use of prophylactic antibiotics may have role in prevention of inflammatory complication, but again not infection.

  14. Miniaturization and globalization of clinical laboratory activities.

    Science.gov (United States)

    Melo, Murilo R; Clark, Samantha; Barrio, Daniel

    2011-04-01

    Clinical laboratories provide an invaluable service to millions of people around the world in the form of quality diagnostic care. Within the clinical laboratory industry the impetus for change has come from technological development (miniaturization, nanotechnology, and their collective effect on point-of-care testing; POCT) and the increasingly global nature of laboratory services. Potential technological gains in POCT include: the development of bio-sensors, microarrays, genetics and proteomics testing, and enhanced web connectivity. In globalization, prospective opportunities lie in: medical tourism, the migration of healthcare workers, cross-border delivery of testing, and the establishment of accredited laboratories in previously unexplored markets. Accompanying these impressive opportunities are equally imposing challenges. Difficulty transitioning from research to clinical use, poor infrastructure in developing countries, cultural differences and national barriers to global trade are only a few examples. Dealing with the issues presented by globalization and the impact of developing technology on POCT, and on the clinical laboratory services industry in general, will be a daunting task. Despite such concerns, with appropriate countermeasures it will be possible to address the challenges posed. Future laboratory success will be largely dependent on one's ability to adapt in this perpetually shifting landscape.

  15. Prospective study of cardiac troponin I release in patients with upper gastrointestinal bleeding.

    Science.gov (United States)

    Iser, David M; Thompson, Alexander J V; Sia, Koon Ket; Yeomans, Neville D; Chen, Robert Y M

    2008-06-01

    The rate of cardiac injury in upper gastrointestinal hemorrhage is unclear. The aims of this study were to determine prospectively the risk of cardiac troponin I release and associated adverse cardiac events in patients with acute upper gastrointestinal hemorrhage. From January to September 2003, we prospectively studied patients with documented hematemesis and melena referred to the gastroenterology unit in a tertiary teaching hospital in Melbourne, Australia. Serial assays for cardiac troponin I were performed at 0, 12 and 24 h. Serial creatine kinase levels and electrocardiographs were also performed. Clinical and biochemical data were collected. The primary endpoint was a troponin level >0.5 microg/L within 24 h of recruitment. Various clinical variables were then compared between the groups of patients with or without troponin rise. A total of 156 patients were included in the study. The mean age was 67 years (range 19-96). There were 104 (67%) male patients. A troponin level of greater than 0.5 microg/L was found in 30/156 (19%); 126 (81%) patients had normal troponin levels. Age greater than 65 years, signs of hemodynamic instability at presentation, a recent history of cardiac disease, cardiovascular compromise following endoscopy, and re-bleeding were associated with troponin release. Upper gastrointestinal bleeding is associated with a risk of cardiac injury of up to 19%. Troponin assay could be used to screen for cardiac damage, especially in elderly patients who present with hemodynamic instability.

  16. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial.

    Science.gov (United States)

    Joda, Tim; Brägger, Urs

    2015-01-01

    To compare time-efficiency in the production of implant crowns using a digital workflow versus the conventional pathway. This prospective clinical study used a crossover design that included 20 study participants receiving single-tooth replacements in posterior sites. Each patient received a customized titanium abutment plus a computer-aided design/computer-assisted manufacture (CAD/CAM) zirconia suprastructure (for those in the test group, using digital workflow) and a standardized titanium abutment plus a porcelain-fused-to-metal crown (for those in the control group, using a conventional pathway). The start of the implant prosthetic treatment was established as the baseline. Time-efficiency analysis was defined as the primary outcome, and was measured for every single clinical and laboratory work step in minutes. Statistical analysis was calculated with the Wilcoxon rank sum test. All crowns could be provided within two clinical appointments, independent of the manufacturing process. The mean total production time, as the sum of clinical plus laboratory work steps, was significantly different. The mean ± standard deviation (SD) time was 185.4 ± 17.9 minutes for the digital workflow process and 223.0 ± 26.2 minutes for the conventional pathway (P = .0001). Therefore, digital processing for overall treatment was 16% faster. Detailed analysis for the clinical treatment revealed a significantly reduced mean ± SD chair time of 27.3 ± 3.4 minutes for the test group compared with 33.2 ± 4.9 minutes for the control group (P = .0001). Similar results were found for the mean laboratory work time, with a significant decrease of 158.1 ± 17.2 minutes for the test group vs 189.8 ± 25.3 minutes for the control group (P = .0001). Only a few studies have investigated efficiency parameters of digital workflows compared with conventional pathways in implant dental medicine. This investigation shows that the digital workflow seems to be more time-efficient than the

  17. Long-term Efficacy, Safety, and Immunogenicity of Biosimilar Infliximab After One Year in a Prospective Nationwide Cohort.

    Science.gov (United States)

    Gonczi, Lorant; Gecse, Krisztina B; Vegh, Zsuzsanna; Kurti, Zsuzsanna; Rutka, Mariann; Farkas, Klaudia; Golovics, Petra A; Lovasz, Barbara D; Banai, Janos; Bene, Laszlo; Gasztonyi, Bea; Kristof, Tunde; Lakatos, Laszlo; Miheller, Pal; Nagy, Ferenc; Palatka, Karoly; Papp, Maria; Patai, Arpad; Salamon, Agnes; Szamosi, Tamas; Szepes, Zoltan; Toth, Gabor T; Vincze, Aron; Szalay, Balazs; Molnar, Tamas; Lakatos, Peter L

    2017-11-01

    It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC). Demographic data were collected and a harmonized monitoring strategy was applied. Clinical remission, response, and biochemical response were evaluated at weeks 14, 30, and 54, respectively. Safety data were registered. Three hundred fifty-three consecutive inflammatory bowel disease (209 CD and 144 UC) patients were included, of which 229 patients reached the week 54 endpoint at final evaluation. Age at disease onset: 24/28 years (median, interquartile range: 19-34/22-39) in patients with CD/UC. Forty-nine, 53, 48% and 86, 81 and 65% of patients with CD reached clinical remission and response by weeks 14, 30, and 54, respectively. Clinical remission and response rates were 56, 41, 43% and 74, 66, 50% in patients with UC. Clinical efficacy was influenced by previous anti-tumor necrosis factor (TNF) exposure in patients with a drug holiday beyond 1 year. The mean C-reactive protein level decreased significantly in both CD and UC by week 14 and was maintained throughout the 1-year follow-up (both UC/CD: P < 0.001). Thirty-one (8.8%) patients had infusion reactions and 32 (9%) patients had infections. Antidrug antibody positivity rates were significantly higher throughout patients with previous anti-TNF exposure; concomitant azathioprine prevented antidrug antibody formation in anti-TNF-naive patients with CD. Results from this prospective nationwide cohort confirm that CT-P13 is effective and safe in inducing and maintaining long-term remission in both CD and UC. Efficacy was influenced by previous anti-TNF exposure; no

  18. A prospective study of 137 patients with Parkinson's disease and anosmia

    Directory of Open Access Journals (Sweden)

    Soltanzadeh A

    1997-08-01

    Full Text Available In this research we tried to study frequency of clinical manifestations in Parkinson's disease. Hence, a prospective study was conducted in 317 patients who were affected by Parkinson's disease. In a questionnaire we collected data of patient's age, gender and signs and symptoms and then analyzed them. The most common features in our patients were tremor and muscular rigidity. Olfactory dysfunction was observed in 61% of our patients. Dysarthria, stooped posture, fixed facial expression, intellectual deterioration and the on-off response had various frequency among the patients. A new and important point in our research was considerable frequency of Anosmia or Hyposmia in spite of it's low prevalence among the patients of previous studies.

  19. Emergency peripartum hysterectomy: results from the prospective Nordic Obstetric Surveillance Study (NOSS).

    Science.gov (United States)

    Jakobsson, Maija; Tapper, Anna-Maija; Colmorn, Lotte Berdiin; Lindqvist, Pelle G; Klungsøyr, Kari; Krebs, Lone; Børdahl, Per E; Gottvall, Karin; Källén, Karin; Bjarnadóttir, Ragnheiður I; Langhoff-Roos, Jens; Gissler, Mika

    2015-07-01

    To assess the prevalence and risk factors of emergency peripartum hysterectomy. Nordic collaborative study. 605 362 deliveries across the five Nordic countries. We collected data prospectively from patients undergoing emergency peripartum hysterectomy within 7 days of delivery from medical birth registers and hospital discharge registers. Control populations consisted of all other women delivering on the same units during the same time period. Emergency peripartum hysterectomy rate. The total number of emergency peripartum hysterectomies reached 211, yielding an incidence rate of 3.5/10 000 (95% confidence interval 3.0-4.0) births. Finland had the highest prevalence (5.1) and Norway the lowest (2.9). Primary indications included an abnormally invasive placenta (n = 91, 43.1%), atonic bleeding (n = 69, 32.7%), uterine rupture (n = 31, 14.7%), other bleeding disorders (n = 12, 5.7%), and other indications (n = 8, 3.8%). The delivery mode was cesarean section in nearly 80% of cases. Previous cesarean section was reported in 45% of women. Both preterm and post-term birth increased the risk for emergency peripartum hysterectomy. The number of stillbirths was substantially high (70/1000), but the case fatality rate stood at 0.47% (one death, maternal mortality rate 0.17/100 000 deliveries). A combination of prospective data collected from clinicians and information gathered from register-based databases can yield valuable data, improving the registration accuracy for rare, near-miss cases. However, proper and uniform clinical guidelines for the use of well-defined international diagnostic codes are still needed. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  20. A prospective study of cow milk allergy in Danish infants during the first 3 years of life. Clinical course in relation to clinical and immunological type of hypersensitivity reaction

    DEFF Research Database (Denmark)

    Høst, A; Halken, S

    1990-01-01

    A cohort of 1749 newborns from the municipality of Odense born during 1985 at the University Hospital were followed prospectively for the development of IgE-mediated and non-IgE-mediated cow milk allergy (CMA) during their first year. The diagnosis of CMA was based on the results of strict...... elimination/milk challenge procedures in a hospital setting, and continued clinical sensitivity to cow milk (CM) was assessed by rechallenging every 6-12 months until the age of 3 years. Further, in infants with CMA, the clinical course of adverse reactions to other foods and the development of allergy......E-mediated CMA, 19 infants showed "immediate reactions" to CM (within 1 h after intake of 2.3 g milk protein) and 20 infants were "late reactors". No significant correlation between IgE-mediated CMA and "immediate reactions" to CM was demonstrated. The overall prognosis of CMA was good with a total recovery...

  1. Measuring costs of data collection at village clinics by village doctors for a syndromic surveillance system-a cross sectional survey from China.

    Science.gov (United States)

    Ding, Yan; Fei, Yang; Xu, Biao; Yang, Jun; Yan, Weirong; Diwan, Vinod K; Sauerborn, Rainer; Dong, Hengjin

    2015-07-25

    Studies into the costs of syndromic surveillance systems are rare, especially for estimating the direct costs involved in implementing and maintaining these systems. An Integrated Surveillance System in rural China (ISSC project), with the aim of providing an early warning system for outbreaks, was implemented; village clinics were the main surveillance units. Village doctors expressed their willingness to join in the surveillance if a proper subsidy was provided. This study aims to measure the costs of data collection by village clinics to provide a reference regarding the subsidy level required for village clinics to participate in data collection. We conducted a cross-sectional survey with a village clinic questionnaire and a staff questionnaire using a purposive sampling strategy. We tracked reported events using the ISSC internal database. Cost data included staff time, and the annual depreciation and opportunity costs of computers. We measured the village doctors' time costs for data collection by multiplying the number of full time employment equivalents devoted to the surveillance by the village doctors' annual salaries and benefits, which equaled their net incomes. We estimated the depreciation and opportunity costs of computers by calculating the equivalent annual computer cost and then allocating this to the surveillance based on the percentage usage. The estimated total annual cost of collecting data was 1,423 Chinese Renminbi (RMB) in 2012 (P25 = 857, P75 = 3284), including 1,250 RMB (P25 = 656, P75 = 3000) staff time costs and 134 RMB (P25 = 101, P75 = 335) depreciation and opportunity costs of computers. The total costs of collecting data from the village clinics for the syndromic surveillance system was calculated to be low compared with the individual net income in County A.

  2. Achilles tendinopathy: A prospective study on the effect of active rehabilitation and steroid injections in a clinical setting.

    Science.gov (United States)

    Wetke, E; Johannsen, F; Langberg, H

    2015-08-01

    In published efficacy studies on Achilles tendinopathy (AT) exercise alone results in improvement in 60-90% of the cases. However, this high success rate cannot be expected in usual clinical practice. We prospectively investigated the effectiveness of a treatment regimen consisting of home-based exercises (concentric, eccentric, and stretching) and optional glucocorticosteroid (GCS) injections in patients with (AT) in a usual clinical setting. Patients unable to commence or progress in exercise were offered GCS, hypothesizing that the GCS would facilitate exercise. Ninety-three consecutive patients with AT referred to two outpatient rheumatology clinics were registered, and seen at five visits over a 6-month period. Exercises seemed to have a slow, but long-lasting effect with GCS having a dramatic short-term effect on symptoms. Twenty-six percent of the patients could proceed with training alone, the remainder received one to three supplementary GCS. There were significant improvements on all outcome variables over time (P ≤ 0.001). At follow-up, 42 had no more symptoms, 29 good result, 16 slightly improved, 4 unchanged, and 2 slightly worse. Overall, 94% of the patients had improved, and we thus recommend the use of GCS injections in AT patients if training alone does not lead to improvement. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  3. Prescribing patterns for inpatients with schizophrenia spectrum disorders in a psychiatric hospital in Slovenia: Results of 16-month prospective, non-interventional clinical research.

    Science.gov (United States)

    Bole, Cvetka Bačar; Pišlar, Mitja; Mrhar, Aleš; Tavčar, Rok

    2017-06-01

    In Slovenia, there has been no evidence about the prescribing patterns for inpatients with psychotic disorders. The research aims to analyze drug utilization patterns for inpatients with psychotic disorder that are coded as F20-F29 according to International Classification of Diseases (ICD) 10 th revision (schizophrenia spectrum disorders). Prospective research was conducted at the Psychiatric Hospital Idrija. The medical records of the inpatients admitted over a 12-month period were collected from the beginning to the end of their hospitalization. A total of 311 inpatients with 446 hospitalizations were included, producing a total of 3954 medication prescriptions. Medications prescribed pro re nata (the use of as needed) were also taken into account. Antipsychotics (N=1149, 43% of prescriptions) were the most often prescribed medications, followed by anxiolytics, antiparkinsonians, antidepressants, mood stabilizers and cardiovascular drugs. A total of 256 (82%) inpatients received at least one pro re nata medication. It was observed that the studied population was treated with one antipsychotic on 27 percent of prescriptions. Inpatients with schizophrenia spectrum disorders were exposed to a large number of different drugs. They were not received only psychotropic drugs but also other medications. With the knowledge about medications the implementation of clinical pharmacy services to the psychiatrists would significantly improve medication of inpatients with psychotic disorders and polypharmacotherapy.

  4. Effectiveness of hyaluronic acid in post-tonsillectomy pain relief and wound healing: a prospective, double-blind, controlled clinical study.

    Science.gov (United States)

    Hancı, Deniz; Altun, Huseyin

    2015-09-01

    To find the effectiveness of hyaluronic acid in post-tonsillectomy pain relief and wound healing. Fifty patients were included in this prospective, double-blind, controlled clinical study (20 males, 30 females mean age of 13.56 years). Hyaluronic acid was applied to one side and the other side was used as a control during tonsillectomy. Therefore, the same patient evaluated and scored the post-tonsillectomy pain, excluding individual bias. Results indicated that patients had significantly lower pain scores for hyaluronic acid treated side (pwound in the hyaluronic acid side was almost completely healed, indicating that the healing was faster with hyaluronic acid compared to control side (pwound healing. Copyright © 2015. Published by Elsevier Ireland Ltd.

  5. Posterior circulation ischemic stroke-clinical characteristics, risk factors, and subtypes in a north Indian population: a prospective study.

    Science.gov (United States)

    Mehndiratta, Manmohan; Pandey, Sanjay; Nayak, Rajeev; Alam, Anwar

    2012-04-01

    Posterior circulation stroke accounts for approximately 20% of all strokes with varied clinical presentation, which differ from strokes in anterior circulation, with reference to etiology, clinical features, and prognosis. Short penetrating and circumferential branches in the posterior circulation supply the brain stem, thalamus, cerebellum, occipital, and medial temporal lobes. We prospectively analyzed 80 participants of posterior circulation ischemic stroke from a registry of 944 participants attending a tertiary care referral university hospital. Patients were analyzed for demographics, stroke risk factors, clinical characteristics, neuroimaging, and stroke subtypes. Posterior circulation ischemic stroke accounted for 80 (8.5%) of 944 of all strokes and 80 (10.45%) of 765 of ischemic stroke. Sixty-three were males with mean age 51.7 ± 14.4 years. Twenty-one participants were young (defined as age less than 45 years). Hypertension was found to be the most common risk factor (63.75%). Vertigo was the most common clinical symptom reported in 45 (56.25%) cases. Sixty-eight (85%) patients had large artery disease, 8 (10%) had documented cardioembolic source, 3 (3.75%) small artery disease, and 2 (2.5%) vasculitis. Posterior cerebral artery was most commonly involved. Topographically distal intracranial involvement was most frequent (66.25%) followed by proximal (30%) and middle intracranial territory (3.75%). Our study demonatrated the occurrence of posterior circulation stroke in relatively younger age group compared to the Western world. We also found higher percentage of large artery disease, while cardioembolism as a less frequent cause of posterior circulation ischemic stroke in North Indian population. Distal territory involvement was most common in our study.

  6. Mobile Phone Questionnaires for Sexual Risk Data Collection Among Young Women in Soweto, South Africa.

    Science.gov (United States)

    Dietrich, Janan J; Lazarus, Erica; Andrasik, Michele; Hornschuh, Stefanie; Otwombe, Kennedy; Morgan, Cecilia; Isaacs, Abby J; Huang, Yunda; Laher, Fatima; Kublin, James G; Gray, Glenda E

    2018-03-29

    Recall and social desirability bias undermine self-report of paper-and-pencil questionnaires. Mobile phone questionnaires may overcome these challenges. We assessed and compared sexual risk behavior reporting via in-clinic paper-and-pencil and mobile phone questionnaires. HVTN 915 was a prospective cohort study of 50 adult women in Soweto, who completed daily mobile phone, and eight interviewer-administered in-clinic questionnaires over 12 weeks to assess sexual risk. Daily mobile phone response rates were 82% (n = 3486/4500); 45% (n = 1565/3486) reported vaginal sex (median sex acts 2 (IQR: 1-3)) within 24 h and 40% (n = 618/1565) consistent condom. Vaginal sex reporting was significantly higher via mobile phone across all visits (p phone and in-clinic paper-based questionnaires across all visits (p = 0.5134). The results show high adherence and reporting of sex on the mobile phone questionnaire. We demonstrate feasibility in collecting mobile phone sexual risk data.

  7. New models for large prospective studies: is there a risk of throwing out the baby with the bathwater?

    Science.gov (United States)

    Bracken, Michael B; Baker, Dean; Cauley, Jane A; Chambers, Christina; Culhane, Jennifer; Dabelea, Dana; Dearborn, Dorr; Drews-Botsch, Carolyn D; Dudley, Donald J; Durkin, Maureen; Entwisle, Barbara; Flick, Louise; Hale, Daniel; Holl, Jane; Hovell, Melbourne; Hudak, Mark; Paneth, Nigel; Specker, Bonny; Wilhelm, Mari; Wyatt, Sharon

    2013-02-15

    Manolio et al. (Am J Epidemiol. 2012;175:859-866) proposed that large cohort studies adopt novel models using "temporary assessment centers" to enroll up to a million participants to answer research questions about rare diseases and "harmonize" clinical endpoints collected from administrative records. Extreme selection bias, we are told, will not harm internal validity, and "process expertise to maximize efficiency of high-throughput operations is as important as scientific rigor" (p. 861). In this article, we describe serious deficiencies in this model as applied to the United States. Key points include: 1) the need for more, not less, specification of disease endpoints; 2) the limited utility of data collected from existing administrative and clinical databases; and 3) the value of university-based centers in providing scientific expertise and achieving high recruitment and retention rates through community and healthcare provider engagement. Careful definition of sampling frames and high response rates are crucial to avoid bias and ensure inclusion of important subpopulations, especially the medically underserved. Prospective hypotheses are essential to refine study design, determine sample size, develop pertinent data collection protocols, and achieve alliances with participants and communities. It is premature to reject the strengths of large national cohort studies in favor of a new model for which evidence of efficiency is insufficient.

  8. Childhood obesity in secondary care: national prospective audit of Australian pediatric practice.

    Science.gov (United States)

    Campbell, Michele; Bryson, Hannah E; Price, Anna M H; Wake, Melissa

    2013-01-01

    In many countries, pediatricians offer skilled secondary care for children with conditions more challenging than can readily be managed in the primary care sector, but the extent to which this sector engages with the detection and management of obesity remains largely unexplored. This study aimed to audit the prevalence, diagnosis, patient, and consultation characteristics of obesity in Australian pediatric practices. This was a national prospective patient audit in Australia. During the course of 2 weeks, members of the Australian Paediatric Research Network prospectively recorded consecutive outpatient consultations by using a brief standardized data collection form. Measures included height, weight, demographics, child and parent health ratings, diagnoses, referrals, investigations, and consultation characteristics. We compared the prevalence of pediatrician-diagnosed and measured obesity (body mass index ≥95th percentile) and top-ranked diagnoses, patient, and consultation characteristics in (a) obese and nonobese children, and (b) obese children with and without a diagnosis. A total of 198 pediatricians recorded 5466 consultations with 2-17 year olds, with body mass index z-scores calculated for 3436 (62.9%). Of the 12.6% obese children, only one-third received an "overweight/obese" diagnosis. Obese children diagnosed as overweight/obese were heavier, older, and in poorer health than those not diagnosed and incurred more Medicare (government-funded health system) cost and referrals. Obesity is infrequently clinically diagnosed by Australian pediatricians and measurement practices vary widely. Further research could focus on supporting and normalizing clinical obesity activities from which pediatricians and parents could see clear benefits. Copyright © 2013 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  9. Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

    Science.gov (United States)

    Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie

    2013-01-01

    Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting

  10. Clinical Profile and Prognosis of Patients with Right Ventricular Dilated Cardiomyopathy: Results of a Prospective Study

    Directory of Open Access Journals (Sweden)

    Ya.R. Akhmatov

    2015-12-01

    Full Text Available The aim of our study was to investigate the clinical prevalence of dilated cardiomyopathy (DCM with predominantly failure of the right-side heart (right ventricular DCM, RV-DCM, and features of the clinical course and prognosis of the disease compared to DCM with biventricular heart failure (BV-HF. The study design suggests a prospective observation of 300 patients with idiopathic DCM between 2000 and 2012. Herewith, we followed the criteria of the WHO/ISFC Task Force (1995 on the Definationa and Classification of Cardiomyopathies. All patients underwent a comprehensive examination. Two groups were formed for further comparative analysis. Group 1 included 22 patients (mean age 42.9±14.3 years, male/female 5/17 with RV-DCM. Group 2 included 38 patients (mean age 43.6±13.8, male/female 29/9 with DCM and BV-HF. The groups were matched for age, sex, NYHA class II-III, and disease duration. According to our aim, we studied 5-year survival prognosis and analyzed the incidence and causes of deaths, as well as the occurrence of nonfatal complications of the disease. Medical therapy for DCM patients was performed according to the CHF therapy guidelines (ACC/AHA 2001, 2005. The results of our investigations during many years of research have shown that the clinical incidence of RV-DCM was 7.3% among all forms of DCM. The study of life prognosis in patients with 2 forms of DCM showed that 5-year mortality of patients was about 50%. Herewith, we detected the differences in causes of death depending on the type of heart damage, primarily development of fatal pulmonary embolism.

  11. Late acute graft-versus-host disease: a prospective analysis of clinical outcomes and circulating angiogenic factors.

    Science.gov (United States)

    Holtan, Shernan G; Khera, Nandita; Levine, John E; Chai, Xiaoyu; Storer, Barry; Liu, Hien D; Inamoto, Yoshihiro; Chen, George L; Mayer, Sebastian; Arora, Mukta; Palmer, Jeanne; Flowers, Mary E D; Cutler, Corey S; Lukez, Alexander; Arai, Sally; Lazaryan, Aleksandr; Newell, Laura F; Krupski, Christa; Jagasia, Madan H; Pusic, Iskra; Wood, William; Renteria, Anne S; Yanik, Gregory; Hogan, William J; Hexner, Elizabeth; Ayuk, Francis; Holler, Ernst; Watanaboonyongcharoen, Phandee; Efebera, Yvonne A; Ferrara, James L M; Panoskaltsis-Mortari, Angela; Weisdorf, Daniel; Lee, Stephanie J; Pidala, Joseph

    2016-11-10

    Late acute (LA) graft-versus-host disease (GVHD) is persistent, recurrent, or new-onset acute GVHD symptoms occurring >100 days after allogeneic hematopoietic cell transplantation (HCT). The aim of this analysis is to describe the onset, course, morbidity, and mortality of and examine angiogenic factors associated with LA GVHD. A prospective cohort of patients (n = 909) was enrolled as part of an observational study within the Chronic GVHD Consortium. Eighty-three patients (11%) developed LA GVHD at a median of 160 (interquartile range, 128-204) days after HCT. Although 51 out of 83 (61%) achieved complete or partial response to initial therapy by 28 days, median failure-free survival was only 7.1 months (95% confidence interval, 3.4-19.1 months), and estimated overall survival (OS) at 2 years was 56%. Given recently described alterations of circulating angiogenic factors in classic acute GVHD, we examined whether alterations in such factors could be identified in LA GVHD. We first tested cases (n = 55) and controls (n = 50) from the Chronic GVHD Consortium and then validated the findings in 37 cases from Mount Sinai Acute GVHD International Consortium. Plasma amphiregulin (AREG; an epidermal growth factor [EGF] receptor ligand) was elevated, and an AREG/EGF ratio at or above the median was associated with inferior OS and increased nonrelapse mortality in both cohorts. Elevation of AREG was detected in classic acute GVHD, but not chronic GVHD. These prospective data characterize the clinical course of LA GVHD and demonstrate alterations in angiogenic factors that make LA GVHD biologically distinct from chronic GVHD. © 2016 by The American Society of Hematology.

  12. A prospective study of the early clinical symptoms following a 2 Gy therapeutic whole-body irradiation; Etude prospective de la symptomatologie clinique precoce apres irradiation corporelle totale therapeutique de 2 Gy

    Energy Technology Data Exchange (ETDEWEB)

    Fizazi, K.; Chaillet, M.P.; Fourquet, A.; Jammet, P.; Cosset, J.M. [Institut Curie, 75 - Paris (France)

    1995-10-01

    Early human tolerance following total body irradiation (TBI) according to the dose received is still poorly known. Thirteen selected patients were prospectively evaluated for clinical side effects during the first 10 hours following a 2 Gy TBI prior to bone marrow transplantation. All of them but one were treated for haematological malignancies and were in clinical remission at the date of TBI. There were 10 males and 3 females, with a median age of 43 y (range 16*61) and a good performance status (WHO 0-1). They received granisetron (3 mg) injected intravenously 1 h before the time of TBI in order to prevent nausea and vomiting. The main symptoms consisted in drowsiness (69%), headache (62%), xerostomia (62%), nausea and vomiting (46%), anorexia (38%), parotid gland pain (23%) and abdominal pain (8%). Their intensity was always moderate, except for 2 patients who experimented severe vomiting. The incidence rate and the time-course of the symptoms of the prodromal phase may proved to be helpful for early clinical evaluation and triage of victims of an accidental irradiation. In particular, absence of fever at the 6{sup th} h after TBI supports the assumption of an estimated exposure dose below 2 Gy. (authors). 23 refs., 2 tabs.

  13. Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol.

    Science.gov (United States)

    Rosenberg, Evan C; Louik, Jay; Conway, Erin; Devinsky, Orrin; Friedman, Daniel

    2017-08-01

    Recent clinical trials indicate that cannabidiol (CBD) may reduce seizure frequency in pediatric patients with certain forms of treatment-resistant epilepsy. Many of these patients experience significant impairments in quality of life (QOL) in physical, mental, and social dimensions of health. In this study, we measured the caregiver-reported Quality of Life in Childhood Epilepsy (QOLCE) in a subset of patients enrolled in a prospective, open-label clinical study of CBD. Results from caregivers of 48 patients indicated an 8.2 ± 9.9-point improvement in overall patient QOLCE (p < 0.001) following 12 weeks of CBD. Subscores with improvement included energy/fatigue, memory, control/helplessness, other cognitive functions, social interactions, behavior, and global QOL. These differences were not correlated to changes in seizure frequency or adverse events. The results suggest that CBD may have beneficial effects on patient QOL, distinct from its seizure-reducing effects; however, further studies in placebo-controlled, double-blind trials are necessary to confirm this finding. Wiley Periodicals, Inc. © 2017 International League Against Epilepsy.

  14. Bacterial meningitis in diabetes patients: a population-based prospective study

    Science.gov (United States)

    van Veen, Kiril E. B.; Brouwer, Matthijs C.; van der Ende, Arie; van de Beek, Diederik

    2016-01-01

    Diabetes mellitus is associated with increased infection rates. We studied clinical features and outcome of community-acquired bacterial meningitis in diabetes patients. Patients were selected from a nationwide, prospective cohort on community-acquired bacterial meningitis performed from March 2006 to October 2014. Data on patient history, symptoms and signs on admission, treatment, and outcome were prospectively collected. A total of 183 of 1447 episodes (13%) occurred in diabetes patients. The incidence of bacterial meningitis in diabetes patients was 3.15 per 100,000 patients per year and the risk of acquiring bacterial meningitis was 2.2-fold higher for diabetes patients. S. pneumoniae was the causative organism in 139 of 183 episodes (76%) and L. monocytogenes in 11 of 183 episodes (6%). Outcome was unfavourable in 82 of 183 episodes (45%) and in 43 of 183 episodes (23%) the patient died. Diabetes was associated with death with an odds ratio of 1.63 (95% CI 1.12–2.37, P = 0.011), which remained after adjusting for known predictors of death in a multivariable analysis (OR 1.98 [95% CI 1.13–3.48], P = 0.017). In conclusion, diabetes is associated with a 2-fold higher risk of acquiring bacterial meningitis. Diabetes is a strong independent risk factor for death in community-acquired adult bacterial meningitis. PMID:27845429

  15. 21 CFR 50.53 - Clinical investigations involving greater than minimal risk and no prospect of direct benefit to...

    Science.gov (United States)

    2010-04-01

    ... minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable... minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable... intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or...

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

    Science.gov (United States)

    Chandra, Praveen; Kumar, Tarun

    2014-01-01

    A prospective, multicenter, post marketing surveillance study to evaluate the safety and effectiveness of the Superia-Sirolimus Eluting Coronary Stent System (SSECSS) implanted during routine clinical practice in India. 1. To study the MACE and in stent and In-segment Loss at Six Months (in a pre selected group of 50 patients). 1. Clinical and procedural success. This is a prospective, open label, single-arm, multicenter (16 sites), post marketing observational study enrolling patients implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) in routine clinical practice in India. A total of 200 Patients of coronary Artery Disease (CAD) implanted with Superia-Sirolimus Eluting Coronary Stent (SSECS) were enrolled. Clinical assessments were done at 30 days, 180 days and at 1, 2 years either telephonically or office visit. A cohort of 50 pre-selected patients were followed up for angiographic evaluation at 180 days. MACE at 12 month of follow up was 1.71%.Late lumen loss, in segment was 0.14 and in stent was 0.10 mm at 6 month of follow-up. TLR was required only in 2 patients. Superia stent is as safe as other biodegradable polymer stent in the market and time has come for biodegradable polymer stent with thin struts. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  17. Prospective Evaluation of Germline Alterations in Patients With Exocrine Pancreatic Neoplasms.

    Science.gov (United States)

    Lowery, Maeve A; Wong, Winston; Jordan, Emmet J; Lee, Jonathan W; Kemel, Yelena; Vijai, Joseph; Mandelker, Diana; Zehir, Ahmet; Capanu, Marinela; Salo-Mullen, Erin; Arnold, Angela G; Yu, Kenneth H; Varghese, Anna M; Kelsen, David P; Brenner, Robin; Kaufmann, Erica; Ravichandran, Vignesh; Mukherjee, Semanti; Berger, Michael F; Hyman, David M; Klimstra, David S; Abou-Alfa, Ghassan K; Tjan, Catherine; Covington, Christina; Maynard, Hannah; Allen, Peter J; Askan, Gokce; Leach, Steven D; Iacobuzio-Donahue, Christine A; Robson, Mark E; Offit, Kenneth; Stadler, Zsofia K; O'Reilly, Eileen M

    2018-02-28

    Identification of pathogenic germline alterations (PGAs) has important clinical and therapeutic implications in pancreas cancer. We performed comprehensive germline testing (GT) in an unselected prospective cohort of patients with exocrine pancreatic neoplasms with genotype and phenotype association to facilitate identification of prognostic and/or predictive biomarkers and examine potential therapeutic implications. Six hundred fifteen unselected patients with exocrine pancreatic neoplasms were prospectively consented for somatic tumor and matched sample profiling for 410-468 genes. GT for PGAs in 76 genes associated with cancer susceptibility was performed in an "identified" manner in 356 (57.9%) patients and in an "anonymized" manner in 259 (42.1%) patients, using an institutional review board-approved protocol. Detailed clinical and pathological features, response to platinum, and overall survival (OS) were collected for the identified cohort. OS was analyzed with Kaplan-Meier curves. PGAs were present in 122 (19.8%) of 615 patients involving 24 different genes, including BRCA1/2, ATM, PALB2, and multiple additional genes associated with the DNA damage response pathway. Of 122 patients with germline alterations, 41.8% did not meet current guidelines for GT. The difference in median OS was not statistically significant between patients with and without PGA (50.8 months, 95% confidence interval = 34.5 to not reached, two-sided P = .94). Loss of heterozygosity was found in 60.0% of BRCA1/2. PGAs frequently occur in pancreas exocrine neoplasms and involve multiple genes beyond those previously associated with hereditary pancreatic cancer. These PGAs are therapeutically actionable in about 5% to 10% of patients. These data support routinely offering GT in all pancreatic ductal adenocarcimona patients with a broad panel of known hereditary cancer predisposition genes.

  18. Upper gastrointestinal bleeding caused by severe esophagitis: a unique clinical syndrome.

    Science.gov (United States)

    Guntipalli, Prathima; Chason, Rebecca; Elliott, Alan; Rockey, Don C

    2014-12-01

    We have recognized a unique clinical syndrome in patients with upper gastrointestinal bleeding who are found to have severe esophagitis. We aimed to more clearly describe the clinical entity of upper gastrointestinal bleeding in patients with severe esophagitis. We conducted a retrospective matched case-control study designed to investigate clinical features in patients with carefully defined upper gastrointestinal bleeding and severe esophagitis. Patient data were captured prospectively via a Gastrointestinal Bleeding Healthcare Registry, which collects data on all patients admitted with gastrointestinal bleeding. Patients with endoscopically documented esophagitis (cases) were matched with randomly selected controls that had upper gastrointestinal bleeding caused by other lesions. Epidemiologic features in patients with esophagitis were similar to those with other causes of upper gastrointestinal bleeding. However, hematemesis was more common in patients with esophagitis 86% (102/119) than in controls 55% (196/357) (p bleeding than those without cirrhosis. We have described a unique clinical syndrome in patients with upper gastrointestinal bleeding who have erosive esophagitis. This syndrome is manifest by typical clinical features and is associated with favorable outcomes.

  19. An outbreak of toxoplasmosis in an aviary collection of Nicobar pigeons (Caloenas nicobaria : clinical communication

    Directory of Open Access Journals (Sweden)

    R.D. Last

    2008-05-01

    Full Text Available Three out of 10 Nicobar pigeons (Caloenas nicobaria in an aviary collection in South Africa were found dead with no presenting clinical symptoms. Histological examination of formalin-fixed tissues from all these birds revealed necrotic foci in various visceral organs (liver, spleen, heart, kidney and lungs, plus diffuse pulmonary congestion and oedema with vasculitis. Numerous protozoal tachyzoites were present in all organs and there was strong positive immunohistochemical (IHC labelling of these organisms for Toxoplasma gondii. Pathology was consistent with acute systemic toxoplasmosis as a consequence of oocyst ingestion. Feral cats were known to be a problem at the facility. Clinical toxoplasmosis is rarely reported in pigeons and this is believed to be the 1st report of toxoplasmosis in Nicobar pigeons.

  20. The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy.

    Science.gov (United States)

    Perrone, F; Jommi, C; Di Maio, M; Gimigliano, A; Gridelli, C; Pignata, S; Ciardiello, F; Nuzzo, F; de Matteis, A; Del Mastro, L; Bryce, J; Daniele, G; Morabito, A; Piccirillo, M C; Rocco, G; Guizzaro, L; Gallo, C

    2016-12-01

    Cancer may cause financial difficulties, but its impact in countries with public health systems is unknown. We evaluated the association of financial difficulties with clinical outcomes of cancer patients enrolled in academic clinical trials performed within the Italian public health system. Data were pooled from 16 prospective multicentre trials in lung, breast or ovarian cancer, using the EORTC quality of life (QOL) C30 questionnaire. Question 28 scores financial difficulties related to disease or treatment in four categories from 'not at all' to 'very much'. We defined financial burden (FB) as any financial difficulty reported at baseline questionnaire, and financial toxicity (FT) as score worsening in a subsequent questionnaire. We investigated (i) the association of FB with clinical outcomes (survival, global QOL response [questions 29/30] and severe toxicity), and (ii) the association of FT with survival. Multivariable analyses were performed using logistic regression models or the Cox model adjusting for trial, gender, age, region and period of enrolment, baseline global QOL and, where appropriate, FB and global QOL response. Results are reported as odds ratio (OR) or hazard ratio (HR) with 95% confidence intervals (CI). At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not associated with risks of death (HR 0.94, 95% CI 0.85-1.04, P = 0.23) and severe toxicity (OR 0.90, 95% CI 0.76-1.06, P = 0.19) but was predictive of a higher chance of worse global QOL response (OR 1.35, 95% CI 1.08-1.70, P = 0.009). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was significantly associated with an increased risk of death (HR 1.20, 95% CI 1.05-1.37, P = 0.007). Several sensitivity analyses confirmed these findings. Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and

  1. Legal clinic gender sensitive method for law students

    Directory of Open Access Journals (Sweden)

    Petrušić Nevena

    2008-01-01

    Full Text Available In this paper, the authors discuss models of integrating gender issues, gender perspective and some gender aspects into the university education. In that context, the authors particularly focus on the concept of clinical legal education in legal clinics offering a specific practical model of teaching gender studies. Legal clinics provide for an innovative approach to gender education of prospective legal professional. The teaching method used in these legal clinics is aimed at raising students' awareness of gender issues and common gender-related biases. In the recent period, the Legal Clinic at the Law Faculty in Niš has achieved excellent results in the Clinical legal education program on the women's rights protection, which clearly proves that legal clinics have good prospects in general legal education.

  2. [Current status and clinical application prospect of Akabane's test].

    Science.gov (United States)

    Wang, Wenjie; Du, Yanjun

    2016-06-12

    The Akabane's test is one of the meridian diagnostic methods. Compared with the current meridian diagnostic methods, it has the advantages of convenience and efficiency, but it also has several disadvantages such as the accuracy is difficult to control, the outcome interpretation is limited, etc. In this paper, the influence factors of Akabane's test were analyzed one by one, especially proposed personal opinion on outcome interpretation, which could ascertain the location and nature of disease, leading to disease syndrome. With accurate syndrome, the treatment plan could be established. The application prospect of Akabane's test was initially explored, and it was proposed that wearable automation equipment could be one of the development directions.

  3. The Effect of Cooperative Writing Activities on Writing Anxieties of Prospective Primary School Teachers

    Science.gov (United States)

    Erdogan, Ozge

    2017-01-01

    The purpose of this research is to determine the effect of cooperative writing activities on the writing anxieties of prospective primary school teachers. The study group of the research is composed of 30 prospective primary school teachers. A mixed method consisting of qualitative and quantitative research methods was used in the collection,…

  4. Fabrication, Quality Assurance, and Quality Control for PROSPECT Detector Component Production

    Science.gov (United States)

    Gustafson, Ian; Prospect (The Precision Reactor Oscillation; Spectrum Experiment) Collaboration

    2017-09-01

    The Precision Reactor Oscillation and Spectrum Experiment (PROSPECT) is an electron antineutrino (νe) detector intended to make a precision measurement of the 235U neutrino spectrum and to search for the possible existence of sterile neutrinos with a mass splitting of Δm2 on the order of 1 eV2 . As a short baseline detector, PROSPECT will be located less than 10 meters from the High Flux Isotope Reactor at Oak Ridge National Laboratory. As PROSPECT intends to search for baseline-dependent oscillations, physical segmentation is needed to better measure the interaction position. PROSPECT will therefore be a segmented detector in two dimensions, thereby improving position measurements. PROSPECT will be segmented into 154 (11×14) 1.2-meter long rectangular tubes, using optical separators. Each separator will consist of a carbon fiber core, laminated with optical reflector (to increase light collection) and Teflon (to ensure compatibility with the scintillator). These optical separators will be held in place via strings of 3D printed PLA rods called `pinwheels.' This poster discusses the fabrication and quality assurance (QA) procedures used in the production of both the PROSPECT optical separators and pinwheels. For the PROSPECT collaboration.

  5. Collection of sequential imaging events for research in breast cancer screening

    Science.gov (United States)

    Patel, M. N.; Young, K.; Halling-Brown, M. D.

    2016-03-01

    Due to the huge amount of research involving medical images, there is a widely accepted need for comprehensive collections of medical images to be made available for research. This demand led to the design and implementation of a flexible image repository, which retrospectively collects images and data from multiple sites throughout the UK. The OPTIMAM Medical Image Database (OMI-DB) was created to provide a centralized, fully annotated dataset for research. The database contains both processed and unprocessed images, associated data, annotations and expert-determined ground truths. Collection has been ongoing for over three years, providing the opportunity to collect sequential imaging events. Extensive alterations to the identification, collection, processing and storage arms of the system have been undertaken to support the introduction of sequential events, including interval cancers. These updates to the collection systems allow the acquisition of many more images, but more importantly, allow one to build on the existing high-dimensional data stored in the OMI-DB. A research dataset of this scale, which includes original normal and subsequent malignant cases along with expert derived and clinical annotations, is currently unique. These data provide a powerful resource for future research and has initiated new research projects, amongst which, is the quantification of normal cases by applying a large number of quantitative imaging features, with a priori knowledge that eventually these cases develop a malignancy. This paper describes, extensions to the OMI-DB collection systems and tools and discusses the prospective applications of having such a rich dataset for future research applications.

  6. The Examining of Prospective Teachers? Views about Renewable and Non-Renewable Energy Sources: A Case Study of Turkey

    Science.gov (United States)

    Hasiloglu, Mehmet Akif

    2014-01-01

    The aim of this study is to determine prospective teachers? views about renewable and non-renewable energy sources. To collect data, a questionnaire with 5 open-ended questions was conveyed to 463 prospective teachers selected from Agri Ibrahim Cecen University. The results showed that almost three fourths of the prospective teachers tend to…

  7. Prospective Payment System (PPS)-Exempt Cancer Hospital Quality Reporting (PCHQR)

    Data.gov (United States)

    U.S. Department of Health & Human Services — Prospective Payment System (PPS)-Exempt Cancer Hospital Quality Reporting (PCHQR) Program currently uses one clinical effectiveness measure—External Beam...

  8. Clinical and Biological Insights from the University of California San Francisco Prospective and Longitudinal Cohort.

    Science.gov (United States)

    Benn, Bryan S; Lehman, Zoe; Kidd, Sharon A; Ho, Melissa; Sun, Sara; Ramstein, Joris; Arger, Nicholas K; Nguyen, Christine P; Su, Robert; Gomez, Antonio; Gelfand, Jeffrey M; Koth, Laura L

    2017-10-01

    Sarcoidosis is a systemic inflammatory disease characterized by non-necrotizing granulomas in involved organs, most commonly the lung. Description of patient characteristics in the Western United States is limited. Furthermore, blood-based measures that relate to clinical sarcoidosis phenotypes are lacking. We present an analysis of a prospective, longitudinal sarcoidosis cohort at a Northern Californian academic medical center. We enrolled 126 sarcoidosis subjects and 64 healthy controls and recorded baseline demographic and clinical characteristics. We used regression models to identify factors independently associated with pulmonary physiology. We tested whether blood transcript levels at study entry could relate to longitudinal changes in pulmonary physiology. White, non-Hispanics composed ~70% of subjects. Hispanics and Blacks had a diagnostic biopsy at an age ~7 years younger than whites. Obstructive, but not restrictive, physiology characterized Scadding Stage IV patients. Subjects reporting use of immunosuppression had worse FEV1%p, FVC%p, and DLCO%p compared to subjects never treated, regardless of Scadding stage. We defined sarcoidosis disease activity by a drop in pulmonary function over 36 months and found that subjects meeting this definition had significant repression of blood gene transcripts related to T cell receptor signaling pathways, referred to as the "TCR factor." Obstructive pulmonary physiology defined Stage IV patients which were mostly white, non-Hispanics. Genes comprising the composite gene expression score, TCR factor, may represent a blood-derived measure of T-cell activity and an indirect measure of active sarcoidosis inflammation. Validation of this measure could translate into individualized treatment for sarcoidosis patients.

  9. Clinical profile and outcome of myasthenic crisis in a tertiary care hospital: A prospective study.

    Science.gov (United States)

    Sharma, Sudhir; Lal, Vivek; Prabhakar, Sudesh; Agarwal, Ritesh

    2013-04-01

    The present understanding of the clinical course, complications, and outcome of myasthenic crisis (MC) is based chiefly on observational studies and retrospective case series. To study the baseline demographic and clinical variables, risk factors, complications, outcome, and mortality in patients of MC. All patients of myasthenia gravis (MG) who presented with myasthenic crisis between July 2009 and December 2010 were included. Ten patients of MC were included in this study. The median age of the patients was 40.5 years (range 14-71 years). Seven were females and three were males. Nine had generalized MG and one patient had oculobulbar involvement only. Median duration of disease was 3 years (range 1 month to17 years). Two patients had thymoma. Two patients had history of thymectomy in the past. Infection was the most common triggering factor accounting for five cases (50%) followed by inadequate treatment/drug withdrawal in three (30%) and steroid initiation and hypokalemia in the remaining two patients (20%). Median duration of MC was 12 days (range 3-28 days). Mortality was in 3 out of 10 (30%) during MC. Management in the intensive care unit (ICU) and treatment with plasma exchange/intravenous immunoglobulins were associated with good outcome. Ventilator support and management in intensive care unit are the most important components in the management of MC. The high mortality rate seen in present study may be more reflective of the actual ground reality in resource constrained developing countries, however, larger prospective studies are needed to confirm these findings.

  10. THE IMPACT OF USING SOCIAL MEDIA ON ACADEMIC ACHIEVEMENT AND ATTITUDES OF PROSPECTIVE TEACHERS

    Directory of Open Access Journals (Sweden)

    Murat Tezer

    2017-12-01

    Full Text Available The current study was conducted to investigate the impact of using social media and internet on the academic achievement of prospective teachers. Focus group of the research could be expressed as 204 prospective teachers that were studying in 2016-2017 fall semesters. To collect data, Attitudes Towards to Social Media Scale was employed. Result of the study revealed that, prospective teachers’ attitudes towards to social media had an influence on academic achievement. Furthermore, it could be stressed that prospective teachers with lower attitudes towards to social media were more likely to have lower academic success when compared with the prospective teachers with higher attitudes towards to social media. In addition to these, results of the current study also expressed that prospective teachers with social media accounts were achieved better grades when compared with the prospective teachers who did not have any social media account. Lastly, it could be indicated that prospective teachers’ attitudes towards to social media was at a moderate level.

  11. Blockchain protocols in clinical trials: Transparency and traceability of consent

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2018-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be

  12. Blockchain protocols in clinical trials: Transparency and traceability of consent.

    Science.gov (United States)

    Benchoufi, Mehdi; Porcher, Raphael; Ravaud, Philippe

    2017-01-01

    Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again.  We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a

  13. ANTIBIOTIC RESISTANCE SPECTRUM OF NON FERMENTING GRAM NEGATIVE BACILLI ISOLATED IN THE ORTHOPEDIC TRAUMATOLOGY CLINIC OF "SF. SPIRIDON" CLINICAL EMERGENCY HOSPITAL IAŞI.

    Science.gov (United States)

    Tucaliuc, D; Alexa, O; Tuchiluş, Cristina Gabriela; Ursu, Ramona Gabriela; Tucaliuc, Elena Simona; Jelihovsky, I; Iancu, Luminiţa Smaranda

    2015-01-01

    The retro-prospective analysis of antibiotic sensitivity of non-fermenting gram negative bacilli strains circulating in the Orthopedics-Traumatology Clinic from "Sf. Spiridon" Emergency Clinical Hospital in view of determining the trend of the resistance phenomenon and indicating the most useful treatment for the infections caused by these strains. The retrospective component was conducted from 01.01.2003 to 31.12.2012, and the result of the diffusimetric antibiograms was taken from the hospital's informatics system; the prospective component of the study involved the collection of pathological products from the patients admitted during January-December 2013, who showed clinical suspicion of infection, in compliance with the general collection norms for the products destined for the bacteriological exam. From the total 167 strains of Pseudomonas aeruginosa isolated and identified from the patients, 48 (28.74%) were sensitive to at least one antibiotic from each tested class, 29 (17.39%) were resistant to a single antibiotic and the rest of 90 (53.89%) showed multiple resistance. We noticed a statistically significant difference between the number of strains sensitive to at least one antibiotic from each tested class and those with multiple resistance (p < 0.05). For the strains of Acinetobacter baumanii combined resistance was identified for 121 (87.04%), out of which 55 (39.56%) were resistant to two classes of antibiotics and the other (47.48%) to all three classes. The most frequently met was the association of resistance to quinolones and aminoglycosides, namely for a number of 49 strains (35.25%); only 3.59% of them were simultaneously sensitive to the three classes of antibiotics. The already high percentages and the rising trends of antibiotic resistance of non-fermenting gram-negative bacteria described in this study confirm the continuous decrease of the efficiency of antimicrobial agents and underline the necessity of a global strategy which aims at all

  14. How common is clinically inactive disease in a prospective cohort of patients with juvenile idiopathic arthritis? The importance of definition.

    Science.gov (United States)

    Shoop-Worrall, Stephanie J W; Verstappen, Suzanne M M; Baildam, Eileen; Chieng, Alice; Davidson, Joyce; Foster, Helen; Ioannou, Yiannis; McErlane, Flora; Wedderburn, Lucy R; Thomson, Wendy; Hyrich, Kimme L

    2017-08-01

    Many criteria for clinically inactive disease (CID) and minimal disease activity (MDA) have been proposed for juvenile idiopathic arthritis (JIA). It is not known to what degree each of these criteria overlap within a single patient cohort. This study aimed to compare the frequency of MDA and CID across different criteria in a cohort of children with JIA at 1 year following presentation. The Childhood Arthritis Prospective Study recruits children at initial presentation to paediatric or adolescent rheumatology in seven UK centres. Children recruited between October 2001 and December 2013 were included. The proportions of children with CID and MDA at 1 year were calculated using four investigator-defined and eight published composite criteria. Missing data were accounted for using multiple imputation under different assumptions. In a cohort of 1415 children and adolescents, 67% patients had no active joints at 1 year. Between 48% and 61% achieved MDA and between 25% and 38% achieved CID using published criteria. Overlap between criteria varied. Of 922 patients in MDA by either the original composite criteria, Juvenile Arthritis Disease Activity Score (JADAS) or clinical JADAS cut-offs, 68% were classified as in MDA by all 3 criteria. Similarly, 44% of 633 children with CID defined by either Wallace's preliminary criteria or the JADAS cut-off were in CID according to both criteria. In a large JIA prospective inception cohort, a majority of patients have evidence of persistent disease activity after 1 year. Published criteria to capture MDA and CID do not always identify the same groups of patients. This has significant implications when defining and applying treat-to-target strategies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  15. A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

    Science.gov (United States)

    Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

    2018-05-01

    Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

  16. Prevalence of sexually transmitted infections among women attending antenatal clinics in Tanga, north eastern Tanzania

    DEFF Research Database (Denmark)

    Chiduo, M; Theilgaard, Z P; Bakari, V

    2012-01-01

    This study aimed to determine the prevalence of sexually transmitted infections (STIs) among HIV-infected and uninfected pregnant women in Tanga, Tanzania. Retrospective data on syphilis and HIV status during 2008-2010 were collected from antenatal clinic (ANC) records. Prospective data were...... collected from HIV-infected (n = 105) and HIV-uninfected pregnant women (n = 100) attending ANCs between April 2009 and August 2010. Syphilis prevalence showed a declining trend (3.1%, 1.4% and 1.3%), while HIV prevalence was stable (6.1%, 6.4% and 5.4%) during 2008-2010. HIV-infected women had...... significantly higher prevalence of trichomoniasis (18.8% versus 5.0%; P HIV-uninfected women. There were no statistically significant...

  17. Online video in clinical skills education of oral medication administration for undergraduate student nurses: a mixed methods, prospective cohort study.

    Science.gov (United States)

    Holland, Agi; Smith, Fiona; McCrossan, Gill; Adamson, Elizabeth; Watt, Susan; Penny, Kay

    2013-06-01

    Improvements in the safety of the prescribing, dispensing and administration of medicines are identified as a priority across international healthcare systems. It is therefore essential that higher education institutions play their part in helping to meet this patient safety objective. New developments in clinical skills education which are aligned to emerging educational theory are available, but evaluations and supportive evidence are limited. To evaluate the use of an online best practice exemplar as an adjunct to the clinical skills teaching of oral medication administration to undergraduate student nurses. Mixed-methods prospective cohort design. Two intakes of undergraduate nursing students (n=168, n=154) undertaking a first year clinical skills based module at a British university. The Control group received standard teaching using lectures and skills classes facilitated by experienced clinical skills lecturers. The Intervention group received the standard teaching and unlimited access to an online video clip of medication administration. Performance and satisfaction were measured using module assessment results and a satisfaction questionnaire. Qualitative data were gathered using focus groups (n=16, n=20). The Intervention group was significantly (p=0.021) more likely to pass the assessment and rate their satisfaction with the teaching significantly higher (pTeaching and Time and when Classroom Learning was positive, the Transfer to Practice of the clinical skill was enhanced. An online video of a best practice exemplar as an adjunct to taught clinical skills sessions improves student assessment results and satisfaction ratings. The video was also reported to positively influence all themes identified in Classroom Learning and was perceived to promote the Transfer to Practice of teaching input. Copyright © 2012 Elsevier Ltd. All rights reserved.

  18. Applicability of the PROSPECT model for Norway spruce needles

    NARCIS (Netherlands)

    Malenovsky, Z.; Albrechtova, J.; Lhotakova, Z.; Zurita Milla, R.; Clevers, J.G.P.W.; Schaepman, M.E.; Cudlin, P.

    2006-01-01

    The potential applicability of the leaf radiative transfer model PROSPECT (version 3.01) was tested for Norway spruce (Picea abies (L.) Karst.) needles collected from stress resistant and resilient trees. Direct comparison of the measured and simulated leaf optical properties between 450¿1000 nm

  19. Clinical studies in restorative dentistry: New directions and new demands.

    Science.gov (United States)

    Opdam, N J M; Collares, K; Hickel, R; Bayne, S C; Loomans, B A; Cenci, M S; Lynch, C D; Correa, M B; Demarco, F; Schwendicke, F; Wilson, N H F

    2018-01-01

    Clinical research of restorative materials is confounded by problems of study designs, length of trials, type of information collected, and costs for trials, despite increasing numbers and considerable development of trials during the past 50 years. This opinion paper aims to discuss advantages and disadvantages of different study designs and outcomes for evaluating survival of dental restorations and to make recommendations for future study designs. Advantages and disadvantages of randomized trials, prospective and retrospective longitudinal studies, practice-based, pragmatic and cohort studies are addressed and discussed. The recommendations of the paper are that clinical trials should have rational control groups, include confounders such as patient risk factors in the data and analysis and should use outcome parameters relevant for profession and patients. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

  20. Comparative effectiveness research in DARTNet primary care practices: point of care data collection on hypoglycemia and over-the-counter and herbal use among patients diagnosed with diabetes.

    Science.gov (United States)

    Libby, Anne M; Pace, Wilson; Bryan, Cathy; Anderson, Heather Orton; Ellis, Samuel L; Allen, Richard Read; Brandt, Elias; Huebschmann, Amy G; West, David; Valuck, Robert J

    2010-06-01

    The Distributed Ambulatory Research in Therapeutics Network (DARTNet) is a federated network of electronic health record (EHR) data, designed as a platform for next-generation comparative effectiveness research in real-world settings. DARTNet links information from nonintegrated primary care clinics that use EHRs to deliver ambulatory care to overcome limitations with traditional observational research. Test the ability to conduct a remote, electronic point of care study in DARTNet practices by prompting clinic staff to obtain specific information during a patient encounter. Prospective survey of patients identified through queries of clinical data repositories in federated network organizations. On patient visit, survey is triggered and data are relinked to the EHR, de-identified, and copied for evaluation. Adult patients diagnosed with diabetes mellitus that scheduled a clinic visit for any reason in a 2-week period in DARTNet primary care practices. Survey on hypoglycemic events (past month) and over-the-counter and herbal supplement use. DARTNet facilitated point of care data collection triggered by an electronic prompt for additional information at a patient visit. More than one-third of respondents (33% response rate) reported either mild (45%) or severe hypoglycemic events (5%) in the month before the survey; only 3 of those were also coded using the ICD-9 (a significant difference in detection rates 37% vs. 1%). Nearly one-quarter of patients reported taking an OTC/herbal, 4% specifically for the treatment of symptoms of diabetes. Prospective data collection is feasible in DARTNet and can enable comparative effectiveness and safety research.

  1. Clinical utility of circulating cell-free DNA in advanced colorectal cancer.

    Directory of Open Access Journals (Sweden)

    Allan A Lima Pereira

    Full Text Available Circulating cell-free DNA (cfDNA isolated from the plasma of cancer patients (pts has been shown to reflect the genomic mutation profile of the tumor. However, physician and patient assessment of clinical utility of these assays in patients with metastatic colorectal cancer (mCRC has not been previously described.Patients were prospectively consented to a prospective genomic matching protocol (Assessment of Targeted Therapies Against Colorectal Cancer [ATTACC], with collection of blood for cfDNA extraction and sequencing of a 54-gene panel in a CLIA-certified lab. Formalin-fixed, paraffin-embedded (FFPE tissue from prior resections or biopsies underwent 50-gene sequencing. Results from both assays were returned to the treating physicians for patient care and clinical trial selection. Follow-up surveys of treating physicians and chart reviews assessed clinical utility.128 mCRC pts were enrolled between 6/2014 and 1/2015. Results were returned in median of 13 and 26 days for cfDNA and FFPE sequencing, respectively. With cfDNA sequencing, 78% (100/128 of samples had a detectable somatic genomic alteration. 50% of cfDNA cases had potentially actionable alterations, and 60% of these could be genomically matched to at least one clinical trial in our institution. 50% (15/30 of these pts enrolled onto an identified matched trial. Physicians reported that the cfDNA testing improved the quality of care they could provide in 73% of the cases, and that 89% of pts reported greater satisfaction with the efforts to personalize experimental therapeutic agents.cfDNA sequencing can provide timely information on potentially actionable mutations and amplifications, thereby facilitating clinical trial enrollment and improving the perceived quality of care.

  2. Preoperative diagnosis of pelvic actinomycosis by clinical cytology

    Directory of Open Access Journals (Sweden)

    Matsuda K

    2012-09-01

    Full Text Available Katsuya Matsuda,1 Hisayoshi Nakajima,2 Khaleque N Khan,1 Terumi Tanigawa,1 Daisuke Hamaguchi,1 Michio Kitajima,1 Koichi Hiraki,1 Shingo Moriyama,3 Hideaki Masuzaki11Department of Obstetrics and Gynecology, Nagasaki University Graduate School of Biomedical Sciences, 2Department of Health Sciences, Nagasaki University Graduate School of Biomedical Sciences, 3Shimabara Maternity Clinic, Nagasaki, JapanBackground: The purpose of this work was to investigate whether clinical cytology could be useful in the preoperative diagnosis of pelvic actinomycosis.Methods: This study involved the prospective collection of samples derived from the endometrium and the uterine cervix, and retrospective data analysis. Nine patients with clinically diagnosed pelvic actinomycosis were enrolled. The clinical and hematological characteristics of patients were recorded, and detection of actinomyces was performed by cytology, pathology, and bacteriological culture of samples and by imprint intrauterine contraceptive device (IUD cytology.Results: The detection rate of actinomyces was 77.7% by combined cervical and endometrial cytology, 50.0% by pathology, and 11.1% by bacterial culture.Conclusion: The higher detection rate of actinomyces by cytology than by pathology or bacteriology suggests that careful cytological examination may be clinically useful in the preoperative diagnosis of pelvic actinomycosis.Keywords: actinomycosis, cytology, pathology, intrauterine contraceptive device, pelvic inflammatory disease

  3. Clinical features and molecular characteristics of childhood community-associated methicillin-resistant Staphylococcus aureus infection in a medical center in northern Taiwan, 2012.

    Science.gov (United States)

    Wang, Hong-Kai; Huang, Chun-Yen; Huang, Yhu-Chering

    2017-07-05

    Since first reported in 2002, the rate of methicillin-resistant Staphylococcus aureus (MRSA) among childhood community-associated (CA) S. aureus infection in Taiwan increased significantly up to 2005. There have been no reports on this issue since then. We prospectively collected clinical S. aureus isolates from the patients Taiwan were MRSA. Though CC59 is still the prevalent community clone, several new clones emerged in northern Taiwan.

  4. Comparison of smartphone application-based vital sign monitors without external hardware versus those used in clinical practice: a prospective trial.

    Science.gov (United States)

    Alexander, John C; Minhajuddin, Abu; Joshi, Girish P

    2017-08-01

    Use of healthcare-related smartphone applications is common. However, there is concern that inaccurate information from these applications may lead patients to make erroneous healthcare decisions. The objective of this study is to study smartphone applications purporting to measure vital sign data using only onboard technology compared with monitors used routinely in clinical practice. This is a prospective trial comparing correlation between a clinically utilized vital sign monitor (Propaq CS, WelchAllyn, Skaneateles Falls, NY, USA) and four smartphone application-based monitors Instant Blood Pressure, Instant Blood Pressure Pro, Pulse Oximeter, and Pulse Oximeter Pro. We performed measurements of heart rate (HR), systolic blood pressures (SBP), diastolic blood pressure (DBP), and oxygen saturation (SpO 2 ) using standard monitor and four smartphone applications. Analysis of variance was used to compare measurements from the applications to the routine monitor. The study was completed on 100 healthy volunteers. Comparison of routine monitor with the smartphone applications shows significant differences in terms of HR, SpO 2 and DBP. The SBP values from the applications were not significantly different from those from the routine monitor, but had wide limits of agreement signifying a large degree of variation in the compared values. The degree of correlation between monitors routinely used in clinical practice and the smartphone-based applications studied is insufficient to recommend clinical utilization. This lack of correlation suggests that the applications evaluated do not provide clinically meaningful data. The inaccurate data provided by these applications can potentially contribute to patient harm.

  5. Clinical characteristics of pneumonia in bedridden patients receiving home care: a 3-year prospective observational study.

    Science.gov (United States)

    Ishida, Tadashi; Tachibana, Hiromasa; Ito, Akihiro; Ikeda, Satoshi; Furuta, Kenjiro; Nishiyama, Akihiro; Noyama, Maki; Tokioka, Fumiaki; Yoshioka, Hiroshige; Arita, Machiko

    2015-08-01

    The aim of the study was to describe the epidemiology, clinical features, antimicrobial treatment, and outcomes of bedridden pneumonia patients receiving home healthcare. A 3-year prospective observational study of poor performance status (PS) 3-4 patients receiving long-term home healthcare and hospitalized at a single center with pneumonia between October 2010 and September 2013 was conducted, and their clinical characteristics were compared with non-bedridden community-acquired pneumonia (CAP) patients. A total of 131 CAP patients with PS 3-4, and 400 CAP patients with PS 0-2 were evaluated. The PS 3-4 patients were older, and exhibited a higher frequency of underlying diseases. Aspiration was thought to be associated with pneumonia in 77.1% of the PS 3-4 patients. Streptococcus pneumoniae was the leading pathogen in both groups, whereas the frequency of streptococci and polymicrobial infections was higher in the PS 3-4 group. The incidence of multidrug-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa was lower than in previous healthcare-associated pneumonia reports. The in-hospital mortality and recurrence rates were significantly higher in the PS 3-4 group than in the good PS group (17.6% vs. 6.0%, p < 0.001 and 15.3% vs. 7.5%, p = 0.008, respectively). The clinical characteristics of pneumonia in poor PS patients were similar to healthcare-associated pneumonia (HCAP), except for the frequency of drug-resistant pathogens. Hence, it might be beneficial to categorize pneumonia in home residents with poor PS separately from pneumonia in CAP patients who were previously healthy or experienced mild comorbidities. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  6. 77 FR 54903 - Proposed collection; comment request

    Science.gov (United States)

    2012-09-06

    ... (619) 553-7335. Title; Associated Form; and OMB Number: Prospective Department of Defense Studies of US... DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DoD-2012-HA-0100] Proposed collection... 31, 2012. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense. [FR...

  7. RNA isolation from bloodstains collected on FTA cards – application in clinical and forensic genetics

    OpenAIRE

    Katarzyna Skonieczna; Jan Styczyński; Anna Krenska; Mariusz Wysocki; Aneta Jakubowska; Tomasz Grzybowski

    2017-01-01

    Aim of the study : In recent years, RNA analysis has been increasingly used in clinical and forensic genetics. Nevertheless, a major limitation of RNA-based applications is very low RNA stability in biological material, due to the RNAse activity. This highlights the need for improving the methods of RNA collection and storage. Technological approaches such as FTA Classic Cards (Whatman) could provide a solution for the problem of RNA degradation. However, different methods of RNA isolation fr...

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

    Science.gov (United States)

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

    2011-09-01

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

  9. Clinical Knowledge Governance Framework for Nationwide Data Infrastructure Projects.

    Science.gov (United States)

    Wulff, Antje; Haarbrandt, Birger; Marschollek, Michael

    2018-01-01

    The availability of semantically-enriched and interoperable clinical information models is crucial for reusing once collected data across institutions like aspired in the German HiGHmed project. Funded by the Federal Ministry of Education and Research, this nationwide data infrastructure project adopts the openEHR approach for semantic modelling. Here, strong governance is required to define high-quality and reusable models. Design of a clinical knowledge governance framework for openEHR modelling in cross-institutional settings like HiGHmed. Analysis of successful practices from international projects, published ideas on archetype governance and own modelling experiences as well as modelling of BPMN processes. We designed a framework by presenting archetype variations, roles and responsibilities, IT support and modelling workflows. Our framework has great potential to make the openEHR modelling efforts manageable. Because practical experiences are rare, prospectively our work will be predestinated to evaluate the benefits of such structured governance approaches.

  10. Natural History of Gas Configurations and Encapsulation in Necrotic Collections During Necrotizing Pancreatitis.

    Science.gov (United States)

    van Grinsven, Janneke; van Brunschot, Sandra; van Baal, Mark C; Besselink, Marc G; Fockens, Paul; van Goor, Harry; van Santvoort, Hjalmar C; Bollen, Thomas L

    2018-05-11

    Decision-making on invasive intervention in patients with clinical signs of infected necrotizing pancreatitis is often related to the presence of gas configurations and the degree of encapsulation in necrotic collections on imaging. Data on the natural history of gas configurations and encapsulation in necrotizing pancreatitis are, however, lacking. A post hoc analysis was performed of a previously described prospective cohort in 21 Dutch hospitals (2004-2008). All computed tomography scans (CTs) performed during hospitalization for necrotizing pancreatitis were categorized per week (1 to 8, and thereafter) and re-assessed by an abdominal radiologist. A total of 639 patients with necrotizing pancreatitis were included, with median four (IQR 2-7) CTs per patient. The incidence of first onset of gas configurations varied per week without a linear correlation: 2-3-13-11-10-19-12-21-12%, respectively. Overall, gas configurations were found in 113/639 (18%) patients and in 113/202 (56%) patients with infected necrosis. The incidence of walled-off necrosis increased per week: 0-3-12-39-62-76-93-97-100% for weeks 1-8 and thereafter respectively. Clinically relevant walled-off necrosis (largely or fully encapsulated necrotic collections) was seen in 162/379 (43%) patients within the first 3 weeks. Gas configurations occur in every phase of the disease and develop in half of the patients with infected necrotizing pancreatitis. Opposed to traditional views, clinically relevant walled-off necrosis occurs frequently within the first 3 weeks.

  11. The clinical impact of PET scanning in patients with melanoma: A prospective study

    International Nuclear Information System (INIS)

    Kalff, V.; Hicks, R.J.; Binns, D.S.; Henderson, M.A.; Ainslie, J.; Jenner, D.A.

    1998-01-01

    Full text: Small series have shown that PET scanning using F-18 fluorodeoxyglucose (FDG), can quite accurately stage patients melanoma. At this Institute these patients are only sent for PET imaging if they have high risk melanomas ( >3 Clarke's grade primaries) or there remains any significant doubt as to their clinical staging or management after the completion of conventional screening. This prospective study examines how PET scan findings influenced the clinical management decisions in 53 patients (29 males, mean age 54±13 yrs: range 31-81 yrs) Referring doctors were asked to indicate reason for the PET scan, stage their patients on the basis of all their current investigations, and to indicate their management plans prior to PET scanning. Follow-up of subsequent patient management at 2-4 weeks post PET scan was then obtained and compared to pre PET plans. PET was used to stage 26 patients, restage 17, follow-up 5, assess recurrence in 3, and other in 2 patients. To date follow-up has shown that in 32/49 (65%) patients PET was used to triage patients to locoregional surgery (10 patients), radical radiotherapy (5 patients), or to continuing follow-up only (17 patients). Three further high risk patients with negative PET scans had sentinel mode biopsy. In only 13 patients was management already determined, with planned treatment being changed in 6. Four patients have not had their post PET scan review yet. To date proven false negative PET scans have occurred in 3 cases, 2 sentinel node biopsies showed microscopic disease, and one scan incorrectly labelled gall-bladder melanoma as hydro-nephrotic kidney. Interestingly in 3 cases, PET discovered other unsuspected tumours (rectum x 2, plasmacytoma). PET scanning has been incorporated into routine management to triage most high risk patients, but it still alters interventions in half of those patients where management has already been planned. PET clearly misses small volume disease, the importance of which is

  12. Clinical application of RT-nested PCR integrated with RFLP in Hantavirus detection and genotyping: a prospective study in Shandong Province, PR China.

    Science.gov (United States)

    Liu, Yun-Xi; Zhao, Zhong-Tang; Cao, Wu-Chun; Xu, Xiao-Qun; Suo, Ji-Jiang; Xing, Yu-Bin; Jia, Ning; Du, Ming-Mei; Liu, Bo-Wei; Yao, Yuan

    2013-01-01

    The aim of the present study was to evaluate the clinical usefulness of applying RT-nested PCR along with RFLP as a method for diagnosis and genotypic differentiation of Hantavirus in the acute-stage sera of HFRS patients as compared to the ELISA technique. A prospective study of patients with suspected HFRS patients was carried out. Sera were collected for serological evaluation by ELISA and RT-nested PCR testing. Primers were selected from the published sequence of the S segment of HTNV strain 76-118 and SEOV strain SR-11, which made it possible to obtain an amplicon of 403 bp by RT-nested PCR. The genotypic differentiations of the RT-nested PCR amplicons were carried out by RFLP. Sequence analyses of the amplicons were used to confirm the accuracy of the results obtained by RFLP. Of the 48 acute-stage sera from suspected HFRS patients, 35 were ELISA-positive while 41 were positive by RT-nested PCR. With Hind III and Hinf I, RFLP profiles of the RT-nested PCR amplicons of the 41 positive sera exhibited two patterns. 33 had RFLP profiles similar to the reference strain R22, and thus belonged to the SEOV type. The other 8 samples which were collected during October-December had RFLP profiles similar to the reference strain 76-118, and thus belonged to the HTNV type. Sequence phylogenetic analysis of RT-nested PCR amplicons revealed sdp1, sdp2 YXL-2008, and sdp3 as close relatives of HTNV strain 76-118, while sdp22 and sdp37 as close relatives of SEOV strain Z37 and strain R22 located in two separate clusters in the phylogenetic tree. These results were identical to those acquired by RFLP. RT-nested PCR integrated with RFLP was a rapid, simple, accurate method for detecting and differentiating the genotypes of Hantavirus in the acute-stage sera of suspected HFRS patients. In Shandong province, the main genotypes of Hantavirus belonged to the SEOV types, while the HTNV types were observed during the autumn-winter season.

  13. Assessment of the environment-related problems and prospects of ...

    African Journals Online (AJOL)

    The study attempted to assess the environment-related problems and prospects of vegetable production in peri – urban areas of Lagos state, Nigeria. A total of one hundred and twenty (120) farmers were interviewed. Data collected were analyzed using frequency, percentages and Pearson Product Moment Correlation ...

  14. Early vs late orthodontic treatment of deepbite: a prospective clinical trial in growing subjects.

    Science.gov (United States)

    Baccetti, Tiziano; Franchi, Lorenzo; Giuntini, Veronica; Masucci, Caterina; Vangelisti, Andrea; Defraia, Efisio

    2012-07-01

    The aim of this prospective clinical trial was to compare the outcomes of prepubertal vs pubertal treatment of deepbite patients with a protocol including biteplane and fixed appliances. A sample of 58 subjects with deepbite completed the study. A total of 34 subjects received treatment with removable biteplane appliances in the mixed dentition at a prepubertal stage of skeletal maturation (early treatment group), and 24 subjects were treated at a pubertal stage of skeletal maturation in the permanent dentition (late treatment group). All subjects of both groups were reevaluated after an average period of 15 months after the completion of fixed appliance therapy. Treatment outcomes were assessed statistically after a phase with removable biteplane appliances and at the posttreatment observation. Treatment duration was significantly shorter in the early treatment group than in the late treatment group. Overbite reduction was significantly greater in the late treatment group (-3.1 mm) than in the early treatment group (-1.4 mm). In the late treatment group, 92% of the patients had a corrected overbite 1 year after therapy. Treatment of deepbite at puberty in the permanent dentition leads to significantly more favorable outcomes than treatment before puberty in the mixed dentition. Copyright © 2012 American Association of Orthodontists. Published by Mosby, Inc. All rights reserved.

  15. Environmental and Clinical Risk Factors for Delirium in a Neurosurgical Center: A Prospective Study.

    Science.gov (United States)

    Matano, Fumihiro; Mizunari, Takayuki; Yamada, Keiko; Kobayashi, Shiro; Murai, Yasuo; Morita, Akio

    2017-07-01

    Few reports of delirium-related risk factors have focused on environmental risk factors and clinical risk factors, such as white matter signal abnormalities on magnetic resonance imaging fluid attenuated inversion recovery images. We prospectively enrolled 253 patients admitted to our neurosurgical center between December 2014 and June 2015 and analyzed 220 patients (100 male patients; mean age, 64.1 years; age range, 17-92 years). An Intensive Care Delirium Screening Checklist score ≥4 points indicated delirium. We evaluated patient factors consisting of baseline characteristics and related factors, such as white matter lesions (WMLs), as well as the surrounding environment. Delirium occurred in 29/220 cases (13.2%). Regarding baseline characteristics, there were significant statistical correlations between delirium and age (P = 0.0187), Hasegawa Dementia Scale-Revised score (P = 0.0022) on admission, and WMLs (P delirium and stay in a neurosurgical care unit (P = 0.0245). Multivariate logistic regression analyses showed statistically significant correlations of delirium with WMLs (P delirium (P = 0.026). WMLs in patients and the surrounding environment are risk factors for delirium in a neurosurgical center. To prevent delirium, clinicians must recognize risk factors, such as high-grade WMLs, and manage environmental factors. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Introducing LIR (Lithotheque Ireland, a reference collection of flaked stone tool raw materials from Ireland

    Directory of Open Access Journals (Sweden)

    Killian Driscoll

    2016-09-01

    Full Text Available The LIR (Lithotheque Ireland reference collection of flaked stone tool raw materials from Ireland began in 2013, and is based on the geological prospection from two projects. The first (2013-2015 focused attention primarily on Carboniferous cherts from the northwest of Ireland, collecting 405 samples. The second (2015-2017 is currently collecting samples of the Cretaceous flint primarily from in situ contexts in the northeast of Ireland, but also includes beach surveys of Cretaceous flint from around the island; the first phase of geological prospection in Autumn 2015 collected 239 samples, with the geological prospection continuing in 2016. Therefore, to date the collection contains over 600 hand samples of chert and flint, along with a small number of other materials (siliceous limestone, tuff, mudstone. The physical reference collection is housed at the UCD School of Archaeology, University College Dublin and contains the geological hand samples along with the various thin sections of the samples that are used for petrographic analysis. The physical collection is complemented by an online database that is to be used alongside the physical collection, or can be used as a stand-alone resource. This paper provides an overview of the database’s metadata and the processes of data entry and editing, to serve as a reference point for the database and the fieldwork undertaken to date, and to serve as a template for other researchers undertaking similar work on lithic reference collections.

  17. Guideline for collection, analysis and presentation of safety data in clinical trials of vaccines in pregnant women

    Science.gov (United States)

    Jones, Christine E.; Munoz, Flor M.; Spiegel, Hans M.L.; Heininger, Ulrich; Zuber, Patrick L.F.; Edwards, Kathryn M.; Lambach, Philipp; Neels, Pieter; Kohl, Katrin S.; Gidudu, Jane; Hirschfeld, Steven; Oleske, James M.; Khuri-Bulos, Najwa; Bauwens, Jorgen; Eckert, Linda O.; Kochhar, Sonali; Bonhoeffer, Jan; Heath, Paul T.

    2017-01-01

    Vaccination during pregnancy is increasingly being used as an effective approach for protecting both young infants and their mothers from serious infections. Drawing conclusions from published studies in this area can be difficult because of the inability to compare vaccine trial results across different studies and settings due to the heterogeneity in the definitions of terms used to assess the safety of vaccines in pregnancy and the data collected in such studies. The guidelines proposed in this document have been developed to harmonize safety data collection in all phases of clinical trials of vaccines in pregnant women and apply to data from the mother, fetus and infant. Guidelines on the prioritization of the data to be collected is also provided to allow applicability in various geographic, cultural and resource settings, including high, middle and low-income countries. PMID:27481360

  18. Clinical Studies

    DEFF Research Database (Denmark)

    Pallesen, Ulla

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

  19. Comparative analysis of three drug-drug interaction screening systems against probable clinically relevant drug-drug interactions: a prospective cohort study.

    Science.gov (United States)

    Muhič, Neža; Mrhar, Ales; Brvar, Miran

    2017-07-01

    Drug-drug interaction (DDI) screening systems report potential DDIs. This study aimed to find the prevalence of probable DDI-related adverse drug reactions (ADRs) and compare the clinical usefulness of different DDI screening systems to prevent or warn against these ADRs. A prospective cohort study was conducted in patients urgently admitted to medical departments. Potential DDIs were checked using Complete Drug Interaction®, Lexicomp® Online™, and Drug Interaction Checker®. The study team identified the patients with probable clinically relevant DDI-related ADRs on admission, the causality of which was assessed using the Drug Interaction Probability Scale (DIPS). Sensitivity, specificity, and positive and negative predictive values of screening systems to prevent or warn against probable DDI-related ADRs were evaluated. Overall, 50 probable clinically relevant DDI-related ADRs were found in 37 out of 795 included patients taking at least two drugs, most common of them were bleeding, hyperkalemia, digitalis toxicity, and hypotension. Complete Drug Interaction showed the best sensitivity (0.76) for actual DDI-related ADRs, followed by Lexicomp Online (0.50), and Drug Interaction Checker (0.40). Complete Drug Interaction and Drug Interaction Checker had positive predictive values of 0.07; Lexicomp Online had 0.04. We found no difference in specificity and negative predictive values among these systems. DDI screening systems differ significantly in their ability to detect probable clinically relevant DDI-related ADRs in terms of sensitivity and positive predictive value.

  20. Cardiac abnormalities in the acquired immunodeficiency syndrome. A prospective study with a clinical-pathological correlation in twenty-one adult patients

    Directory of Open Access Journals (Sweden)

    Herdy Gesmar Volga Haddad

    1999-01-01

    Full Text Available OBJECTIVE - To evaluate the cardiac abnormalities and their evolution during the course of the acquired immunodeficiency syndrome, as well as to correlate clinical and pathological data. METHODS - Twenty-one patients, admitted to the hospital with the diagnosis of acquired immunodeficiency syndrome, were prospectively studied and followed until their death. Age ranged from 19 to 42 years (17 males. ECG and echocardiogram were also obtained every six months. After death, macro- and microscopic examinations were also performed. RESULTS - The most frequent causes of referral to the hospital were: diarrhea or repeated pneumonias, tuberculosis, toxoplasmosis or Kaposi sarcoma. The most frequent findings were acute or chronic pericarditis (42% and dilated cardiomyopathy (19%. Four patients died of cardiac problems: infective endocarditis, pericarditis with pericardial effusion, bacterial myocarditis and infection by Toxoplasma gondii. CONCLUSION - Severe cardiac abnormalities were the cause of death in some patients. In the majority of the patients, a good correlation existed between clinical and anatomical-pathological data. Cardiac evaluation was important to detect early manifestations and treat them accordingly, even in asymptomatic patients.

  1. Do Urinary Cystine Parameters Predict Clinical Stone Activity?

    Science.gov (United States)

    Friedlander, Justin I; Antonelli, Jodi A; Canvasser, Noah E; Morgan, Monica S C; Mollengarden, Daniel; Best, Sara; Pearle, Margaret S

    2018-02-01

    An accurate urinary predictor of stone recurrence would be clinically advantageous for patients with cystinuria. A proprietary assay (Litholink, Chicago, Illinois) measures cystine capacity as a potentially more reliable estimate of stone forming propensity. The recommended capacity level to prevent stone formation, which is greater than 150 mg/l, has not been directly correlated with clinical stone activity. We investigated the relationship between urinary cystine parameters and clinical stone activity. We prospectively followed 48 patients with cystinuria using 24-hour urine collections and serial imaging, and recorded stone activity. We compared cystine urinary parameters at times of stone activity with those obtained during periods of stone quiescence. We then performed correlation and ROC analysis to evaluate the performance of cystine parameters to predict stone activity. During a median followup of 70.6 months (range 2.2 to 274.6) 85 stone events occurred which could be linked to a recent urine collection. Cystine capacity was significantly greater for quiescent urine than for stone event urine (mean ± SD 48 ± 107 vs -38 ± 163 mg/l, p stone activity (r = -0.29, p r = -0.88, p r = -0.87, p stone quiescence. Decreasing the cutoff to 90 mg/l or greater improved sensitivity to 25.2% while maintaining specificity at 90.9%. Our results suggest that the target for capacity should be lower than previously advised. Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  2. Nursing students’ experiences of clinical education setting

    Directory of Open Access Journals (Sweden)

    Rahnama M

    2015-08-01

    Full Text Available Background and Objective: Appropriate clinical environment has an important role in preparing students to use learned knowledge in practice through providing learning opportunities. Since the students’ experiences in the clinical setting affect on quality of their learning, the current study aimed to explain the experiences of nursing students concerning clinical education setting. Materials and Method: The current study was conducted based on conventional content analysis. Sampling was done purposively and the participants were 13 last year nursing students in Zabol Nursing and Midwifery School in 2013-2014. Data collection was done through in-depth semi-structured interviews. Data analysis was conducted through qualitative content analysis approach. Results: Based on the results, five major categories including threats, vision, dual forces, mindset and students’ action to clinical education and also10 subcategorie were identified. Conclusion: Since the formation of students’ experiences in these environments is one of the predictive factors in achieving their learning and in facilitating the professionalization process, thus the attention of managers in clinical settings is very important for decreasing the threats and concerns for students. In this way, the marred prospects of profession can be recovered through the meeting students’ expectations, attractiveness of the profession can be increased and the positive belief, actions and feelings can be created in students.

  3. The Perception of Tertiary Institutions Prospective Teachers on the Benefits of Teaching Practice

    Directory of Open Access Journals (Sweden)

    Hassan Olusola

    2017-03-01

    Full Text Available This study assessed the perception of two tertiary institutions prospective teachers’ on the Benefits of Teaching Practice in Ogun State. Survey research design was adopted for the study. A sample of four hundred students was randomly selected for the study. Prospective Teachers Perception on Teaching practice Benefits Questionnaire (PTPTPBQ with the reliability coefficient of 0.80 was administered on the respondents. Data collected was analyzed using Mean Score, Charts, Percentages and t-test of significance. The study reveals that prospective teachers have low perception on the benefits of teaching practice also, finance and housing were the two major challenges faced by prospective teachers.. It is evident from the findings that there is need for concerted effort by school to orientate prospective teachers on the benefits of teaching practice. Also the major challenges faced by prospective teachers should also be addressed to allow them have good grasp from the benefits of teaching practice.

  4. A PROSPECTIVE STUDY OF CLINICAL OUTCOME AFTER USING LIGAMENTOTAXIS IN MANAGEMENT OF DISTAL RADIUS FRACTURES

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    Chandrashekhar V. Mudgal

    2017-04-01

    Full Text Available BACKGROUND A study was done to evaluate the effect of the ligamentotaxis in the management of intraarticular fractures of the distal radius. MATERIALS AND METHODS 34 patients were studied prospectively between March 2014 and February 2016. All patients had intraarticular fracture of distal end of radius and all were treated with ligamentotaxis after closed reduction with fluoroscopic guidance. The follow-up period was 12 months. At the time of surgery, the mean age was 45.29 years. RESULTS In all fracture cases, the mean of fracture union was 5.8 weeks. During the final follow-up, the mean range of motion was 55.30 in flexion, 56.60 in extension, 21.0 in ulnar deviation, 9.00 in radial deviation, 70.30 in pronation and 67.10 in supination. According to the scoring system of Gartland and Werley, the clinical and functional outcomes showed that 15 patients (44.1% had excellent results, 14 (41.1% had good results, 3 (8.8% had fair results and 2 (5.8% had poor results. CONCLUSION Closed reduction under fluoroscopic image guidance and the ligamentotaxis is useful and effective in the treatment of intraarticular fractures of the distal radius.

  5. Examining Development of Curriculum Knowledge of Prospective Mathematics Teachers

    Science.gov (United States)

    Sahin, Ömer; Soylu, Yasin

    2017-01-01

    Explanatory-confirmatory research design, one of the mixed methods research designs, was used in this study to investigate Curriculum Knowledge developments of prospective teachers regarding algebra. Cross-sectional study method, as a type of descriptive research and one of the non-experimental research designs, was used to collect quantitative…

  6. Procedures for assessing psychological predictors of injuries in circus artists: a pilot prospective study.

    Science.gov (United States)

    Shrier, Ian; Raglin, John S; Levitan, Emily B; Mittleman, Murray A; Steele, Russell J; Powell, Janette

    2014-06-11

    Research on psychological risk factors for injury has focused on stable traits. Our objective was to test the feasibility of a prospective longitudinal study designed to examine labile psychological states as risk factors of injury. We measured psychological traits at baseline (mood, ways of coping and anxiety), and psychological states every day (1-item questions on anxiety, sleep, fatigue, soreness, self-confidence) before performances in Cirque du Soleil artists of the show "O". Additional questions were added once per week to better assess anxiety (20-item) and mood. Questionnaires were provided in English, French, Russian and Japanese. Injury and exposure data were extracted from electronic records that are kept as part of routine business practices. The 43.9% (36/82) recruitment rate was more than expected. Most artists completed the baseline questionnaires in 15 min, a weekly questionnaire in <2 min and a daily questionnaire in <1 min. We improved the formatting of some questions during the study, and adapted the wording of other questions to improve clarity. There were no dropouts during the entire study, suggesting the questionnaires were appropriate in content and length. Results for sample size calculations depend on the number of artists followed and the minimal important difference in injury rates, but in general, preclude a purely prospective study with daily data collection because of the long follow-up required. However, a prospective nested case-crossover design with data collection bi-weekly and at the time of injury appears feasible. A prospective study collecting psychological state data from subjects who train and work regularly together is feasible, but sample size calculations suggest that the optimal study design would use prospective nested case-crossover methodology.

  7. Influence of Age on Clinical Performance of Mandibular Two-Implant Overdentures : A 10-Year Prospective Comparative Study

    NARCIS (Netherlands)

    Hoeksema, Arie R.; Visser, Anita; Raghoebar, Gerry M.; Vissink, Arjan; Meijer, Henny J. A.

    Purpose: The aim of this prospective comparative study was to assess whether age has influence on peri-implant health in patients treated with mandibular two-implant overdentures during a 10-year evaluation period. Materials and Methods: A prospective study was carried out with two groups of

  8. Genetic, clinical and pharmacological determinants of out-of-hospital cardiac arrest: rationale and outline of the AmsteRdam Resuscitation Studies (ARREST) registry

    Science.gov (United States)

    Blom, M T; van Hoeijen, D A; Bardai, A; Berdowski, J; Souverein, P C; De Bruin, M L; Koster, R W; de Boer, A; Tan, H L

    2014-01-01

    Introduction Out-of-hospital cardiac arrest (OHCA) is a major public health problem. Recognising the complexity of the underlying causes of OHCA in the community, we aimed to establish the clinical, pharmacological, environmental and genetic factors and their interactions that may cause OHCA. Methods and analysis We set up a large-scale prospective community-based registry (AmsteRdam Resuscitation Studies, ARREST) in which we prospectively include all resuscitation attempts from OHCA in a large study region in the Netherlands in collaboration with Emergency Medical Services. Of all OHCA victims since June 2005, we prospectively collect medical history (through hospital and general practitioner), and current and previous medication use (through community pharmacy). In addition, we include DNA samples from OHCA victims with documented ventricular tachycardia/fibrillation during the resuscitation attempt since July 2007. Various study designs are employed to analyse the data of the ARREST registry, including case–control, cohort, case only and case-cross over designs. Ethics and dissemination We describe the rationale, outline and potential results of the ARREST registry. The design allows for a stable and reliable collection of multiple determinants of OHCA, while assuring that the patient, lay-caregiver or medical professional is not hindered in any way. Such comprehensive data collection is required to unravel the complex basis of OHCA. Results will be published in peer-reviewed journals and presented at relevant scientific symposia. PMID:25332818

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

    Science.gov (United States)

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

    2018-01-01

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

  10. Sexual Function After Stereotactic Body Radiotherapy for Prostate Cancer: Results of a Prospective Clinical Trial

    International Nuclear Information System (INIS)

    Wiegner, Ellen A.; King, Christopher R.

    2010-01-01

    Purpose: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). Methods and Materials: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. Results: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged ≥70 years (p = 0.008). Penile bulb dose was not associated with ED. Conclusions: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.

  11. Food assistance is associated with improved body mass index, food security and attendance at clinic in an HIV program in central Haiti: a prospective observational cohort study

    Directory of Open Access Journals (Sweden)

    Ivers Louise C

    2010-08-01

    Full Text Available Abstract Background Few data are available to guide programmatic solutions to the overlapping problems of undernutrition and HIV infection. We evaluated the impact of food assistance on patient outcomes in a comprehensive HIV program in central Haiti in a prospective observational cohort study. Methods Adults with HIV infection were eligible for monthly food rations if they had any one of: tuberculosis, body mass index (BMI 2, CD4 cell count 3 (in the prior 3 months or severe socio-economic conditions. A total of 600 individuals (300 eligible and 300 ineligible for food assistance were interviewed before rations were distributed, at 6 months and at 12 months. Data collected included demographics, BMI and food insecurity score (range 0 - 20. Results At 6- and 12-month time-points, 488 and 340 subjects were eligible for analysis. Multivariable analysis demonstrated that at 6 months, food security significantly improved in those who received food assistance versus who did not (-3.55 vs -0.16; P Conclusions Food assistance was associated with improved food security, increased BMI, and improved adherence to clinic visits at 6 and 12 months among people living with HIV in Haiti and should be part of routine care where HIV and food insecurity overlap.

  12. COMPARATIVE STUDY OF CULTURE AND SENSITIVITY PATTERNS OF PRE OPERATIVE MID STREAM URINE WITH RENAL PELVIC URINE AND STONE TO PREDICT UROSEPSIS FOLLOWING PERCUTANEOUS NEPHROLITHOTOMY: A PROSPECTIVE CLINICAL STUDY

    Directory of Open Access Journals (Sweden)

    Bhargava Vardhana Reddy

    2015-11-01

    Full Text Available INTRODUCTION : Percutaneous nephrolithotomy (PCNL is the most frequently performed surgery for stone disease at our institution. Nearly 100 PCNL procedures are being performed in a year at our institution. Septicemia following PCNL can be catastrophic despite sterile preoperative urine and prophylactic antibiotics. Infected stones, obstructed kidneys , and comorbidit y have been held responsible. In this study we analyzed various culture specimens, namely Mid - stream urine (MSU, renal pelvic urine and crushed stones. MATERIALS AND METHODS : We performed a prospective clinical study in all our patients undergoing PCNL b etween January 2013 and December 2014. MSU was sent for culture and sensitivity testing (C&S one day prior to surgery. Percutaneous access into the ipsilateral pelvicaliceal system is achieved under image intensification using a fine, 14 gauge Kellet need le. Urine from the pelvicaliceal system is first aspirated and sent as pelvic urine C&S. Stone fragments are collected to be proces0sed for C&S. The data collected were divided into 3 main groups, that is MSU C&S, pelvic urine C&S and stone C&S. RESULTS : A total of 83 patients were included in the study, of this MSU C&S was positive in 9/83 (10.8% patients, Pelvic C&S in 10 /73 (13.7% patients and Stone C&S in 25/83 (30.1% patients. Out of 25 cases of stone culture positive patients 17 patients develope d Systemic Inflammatory Response Syndrome (SIRS but only 2 patients developed SIRS in MSU C & S positive patients. CONCLUSIONS: The results of our study suggest that positive stone C&S is the better predictor of potential urosepsis than MSU. Stone cultur e is available only after surgery but appears to be the best guide for antibiotic therapy in case of sepsis. So the routine collection of stone for C&S will be beneficial

  13. Educational Level, Anticoagulation Quality, and Clinical Outcomes in Elderly Patients with Acute Venous Thromboembolism: A Prospective Cohort Study.

    Science.gov (United States)

    Hofmann, Eveline; Faller, Nicolas; Limacher, Andreas; Méan, Marie; Tritschler, Tobias; Rodondi, Nicolas; Aujesky, Drahomir

    2016-01-01

    Whether the level of education is associated with anticoagulation quality and clinical outcomes in patients with acute venous thromboembolism (VTE) is uncertain. We thus aimed to investigate the association between educational level and anticoagulation quality and clinical outcomes in elderly patients with acute VTE. We studied 817 patients aged ≥65 years with acute VTE from a Swiss prospective multicenter cohort study (09/2009-12/2013). We defined three educational levels: 1) less than high school, 2) high school, and 3) post-secondary degree. The primary outcome was the anticoagulation quality, expressed as the percentage of time spent in the therapeutic INR range (TTR). Secondary outcomes were the time to a first recurrent VTE and major bleeding. We adjusted for potential confounders and periods of anticoagulation. Overall, 56% of patients had less than high school, 25% a high school degree, and 18% a post-secondary degree. The mean percentage of TTR was similar across educational levels (less than high school, 61%; high school, 64%; and post-secondary, 63%; P = 0.36). Within three years of follow-up, patients with less than high school, high school, and a post-secondary degree had a cumulative incidence of recurrent VTE of 14.2%, 12.9%, and 16.4%, and a cumulative incidence of major bleeding of 13.3%, 15.1%, and 15.4%, respectively. After adjustment, educational level was neither associated with anticoagulation quality nor with recurrent VTE or major bleeding. In elderly patients with VTE, we did not find an association between educational level and anticoagulation quality or clinical outcomes.

  14. Informed consent during the clinical emergency of acute myocardial infarction (HERO-2 consent substudy): a prospective observational study.

    Science.gov (United States)

    Williams, Barbara F; French, John K; White, Harvey D

    2003-03-15

    Anxiety, fear, pain, and treatment with morphine might compromise the ability of patients to comprehend information about, and give informed consent for, participation in clinical trials. We aimed to assess whether patients with acute myocardial infarction could understand written and verbal information and whether they were competent to give autonomous informed consent to participate in a clinical trial. We prospectively studied 399 patients with acute myocardial infarction in 16 hospitals in New Zealand and Australia who were eligible for participation in the Hirulog and Early Reperfusion or Occlusion (HERO)-2 trial. We assessed readability of patient information sheets, patients' educational status, their views of the consent process, comprehension of verbal and written information, and competence to give consent. The patient information sheet needed a year 13 (age 18) educational level for comprehension, although only 75 of 345 patients (22%) had been educated beyond secondary school. Only 63 of 346 (18%) read the patient information sheet before giving or refusing consent to participate. Patients who gave consent were more likely to report good or partial comprehension of the information provided than were those who refused consent (272 [89%] vs 14 [70%], respectively; p=0.009). In an assessment of competence to make an autonomous decision, 75 of 145 (52%) were ranked at the lowest grade and 26 (18%) were not competent to consent. Although the consent process for HERO-2 met regulatory requirements for clinical trials, it was inappropriate for the needs of most patients. The patients' comprehension of the information provided and their competence to autonomously give consent was less than optimum.

  15. Prospective study of Outcomes in Sporadic versus Hereditary breast cancer (POSH): study protocol

    International Nuclear Information System (INIS)

    Eccles, Diana; Gerty, Sue; Simmonds, Peter; Hammond, Victoria; Ennis, Sarah; Altman, Douglas G

    2007-01-01

    Young women presenting with breast cancer are more likely to have a genetic predisposition to the disease than breast cancer patients in general. A genetic predisposition is known to increase the risk of new primary breast (and other) cancers. It is unclear from the literature whether genetic status should be taken into consideration when planning adjuvant treatment in a young woman presenting with a first primary breast cancer. The primary aim of the POSH study is to establish whether genetic status influences the prognosis of primary breast cancer independently of known prognostic factors. The study is a prospective cohort study recruiting 3,000 women aged 40 years or younger at breast cancer diagnosis; the recruiting period covers 1 st June 2001 to 31 st December 2007. Written informed consent is obtained at study entry. Family history and known epidemiological risk data are collected by questionnaire. Clinical information about diagnosis, treatment and clinical course is collected and blood is stored. Follow up data are collected annually after the first year. An additional recruitment category includes women aged 41 to 50 years who are found to be BRCA1 or BRCA2 gene carriers and were diagnosed with their first breast cancer during the study recruiting period. Power estimates were based on 10% of the cohort carrying a BRCA1 gene mutation. Preliminary BRCA1 and BRCA2 mutation analysis in a pilot set of study participants confirms we should have 97% power to detect a difference of 10% in event rates between gene carriers and sporadic young onset cases. Most of the recruited patients (>80%) receive an anthracycline containing adjuvant chemotherapy regimen making planned analyses more straightforward

  16. Endodontic flare-ups: a prospective study.

    Science.gov (United States)

    Alves, Vanessa de Oliveira

    2010-11-01

    The objective of this prospective clinical study was to evaluate the incidence of flare-ups (pain and/or swelling requiring endodontic interappointment and emergency treatment) and identify the risk factors associated with their occurrence in patients who received endodontic treatment from June 2006 to June 2007 at the endodontics clinic of the São Paulo Dental Association (APCD), Jardim Paulista branch, São Paulo, Brazil. The incidence of flare-ups was 1.71% out of 408 teeth that had received endodontic therapy. Statistical analysis using the chi-squared test (P flare-up rate and the presence of a periradicular radiolucency. Copyright © 2010 Mosby, Inc. All rights reserved.

  17. Prospective of clinical drugs for radioprotection

    International Nuclear Information System (INIS)

    Alok, Amit; Kumar, Sandeep; Kumar, Arun; Chaudhury, N.K.

    2014-01-01

    We are living in an era of nuclear power where power derived from nuclear reaction is used for power generation as well as for nuclear weapons. The terrorism and the threat of dirty bombs looms around the civilized population. Therefore, there is a need to develop radioprotector which could prevent against the harmful effect of radiation. The research on radioprotector started more than fifty years ago but still there is no approved radioprotector in the drug market. Hundreds of lead molecule have been screened and have shown varying amount of radioprotection either in vitro or in vivo or in both. Only one drug amifostine was approved by FDA but due to its toxicity in head and neck cancer, this drug is no more in use. Antioxidants too have proven to be a potential radioprotector but the dose required for radioprotection is too high for maintenance of homeostasis in physiological system. We have taken an alternative approach of using clinical drugs like diclofenac and tetracycline for development of approach for radioprotection and reported the radioprotective role of diclofenac. The advantage of using clinical drug is its wide availability in the market and the ease with which it could be channelized for radioprotection. Antiradical assays have demonstrated possible use of tetracycline for radioprotection. Tetracycline has also ability to reduce oxidative damages ex vivo. Studies related to comet assay as well as antioxidant assays in different organs are in progress for designing further work for efficacy and elucidation of mechanisms. (author)

  18. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review.

    Science.gov (United States)

    Elizaga, Marnie L; Vasan, Sandhya; Marovich, Mary A; Sato, Alicia H; Lawrence, Dale N; Chaitman, Bernard R; Frey, Sharon E; Keefer, Michael C

    2013-01-01

    Vaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines. Four clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine. Four hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine. Prospective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants. ClinicalTrials.gov NCT00082446 NCT003766090 NCT00252148 NCT00083603 NCT00301184 NCT00428337.

  19. Prospective surveillance for cardiac adverse events in healthy adults receiving modified vaccinia Ankara vaccines: a systematic review.

    Directory of Open Access Journals (Sweden)

    Marnie L Elizaga

    Full Text Available Vaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines.Four clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls, and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine.Four hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12% had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine.Prospective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants.ClinicalTrials.gov NCT00082446 NCT003766090 NCT00252148 NCT00083603 NCT00301184 NCT00428337.

  20. Estimating the Prospectivity of Geothermal Resources Using the Concept of Hydrogeologic Windows

    Science.gov (United States)

    Bielicki, Jeffrey; Blackwell, David; Harp, Dylan; Karra, Satish; Kelley, Richard; Kelley, Shari; Middleton, Richard; Person, Mark; Sutula, Glenn; Witcher, James

    2016-04-01

    In this Geothermal Play Fairways Analysis project we sought to develop new ways to analyze geologic, geochemical, and geophysical data to reduce the risk and increase the prospects of successful geothermal exploration and development. We collected, organized, and analyzed data from southwest New Mexico in the context of an integrated framework that combines the data for various signatures of a geothermal resource into a cohesive analysis of the presence of heat, fluid, and permeability. We incorporated data on structural characteristics (earthquakes, geophysical logs, fault location and age, basement depth), topographic and water table elevations, conservative ion concentrations, and thermal information (heat flow, bottom hole temperature, discharge temperature, and basement heat generation). These data were combined to create maps that indicate structural analysis, slope, geothermometry, and heat. We also mapped discharge areas (to constrain elevations where groundwater may be discharged through modern thermal springs or paleo-thermal springs) and subcrops: possible erosionally- or structurally-controlled breaches in regional-scale aquitards that form the basis of our hydrogeologic windows concept. These two maps were particularly useful in identifying known geothermal systems and narrowing the search for unknown geothermal prospects. We further refined the "prospectivity" of the areas within the subcrops and discharge areas by developing and applying a new method for spatial association analysis to data on known and inferred faults, earthquakes, geochemical thermometers, and heat flow. This new methodology determines the relationships of the location and magnitudes of observations of these data with known geothermal sites. The results of each of the six spatial association analyses were weighted between 0 and 1 and summed to produce a prospectivity score between 0 and 6, with 6 indicating highest geothermal potential. The mean value of prospectivity for all

  1. Rural habitat as risk factor for hepatitis E virus seroconversion in HIV-infected patients: A prospective longitudinal study.

    Science.gov (United States)

    Rivero-Juarez, A; Cuenca-Lopez, F; Martinez-Peinado, A; Camacho, A; Real, L M; Frias, M; Gordon, A; Cantisán, S; Torre-Cisneros, J; Pineda, J A; Rivero, A

    2017-11-01

    Our objective was to determine the incidence and clinical manifestations of acute hepatitis E virus (HEV) in HIV-infected patients. A prospective longitudinal study including HIV-infected HEV-seronegative patients was conducted; HEV seroconversion (to IgG and/or IgM) was the main outcome variable. All patients were tested for HEV antibodies every 3-6 months. For patients who developed HEV seroconversion, a data collection protocol was followed to identify associated clinical manifestations and analytical alterations. A total of 627 patients (89.9%) were followed during a median of 11.96 months (IQR: 8.52-14.52 months) and formed the study population. Forty-one patients developed detectable anti-HEV antibodies (7.2 cases per 100 patients/year). Our study found a high incidence of HEV in HIV-infected patients in southern Spain strongly associated with a rural habitat. © 2017 Blackwell Verlag GmbH.

  2. Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study.

    Science.gov (United States)

    Turchetti, Giuseppe; Pierotti, Francesca; Palla, Ilaria; Manetti, Stefania; Freschi, Cinzia; Ferrari, Vincenzo; Cuschieri, Alfred

    2017-02-01

    Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA). The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches. The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p DMLS. Total costs of general surgery RAS were significantly higher than those of OS (p DMLS general surgery. Indirect costs were significantly lower in RAS compared to both DMLS general surgery and OS gynecological surgery due to the shorter length of hospital stay of RAS approach (p < 0.001). Additionally, in all specialties compared to OS, patients treated by RAS experienced a quicker recovery and significantly less pain during the hospitalization and after discharge. The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

  3. Comparative evaluation of pregnancy outcome in gonadotrophin-clomiphene combination vs clomiphene alone in polycystic ovarian syndrome and unexplained infertility-A prospective clinical trial

    Directory of Open Access Journals (Sweden)

    Shiuli Mukherjee

    2010-01-01

    Full Text Available Objectives: A large prospective clinical trial was conducted to compare the efficacy of single dose uFSH and clomiphene citrate combination with clomiphene citrate alone for ovulation induction to improve the pregnancy rate. Materials and Methods: The study was a randomized, prospective clinical trial. Totally, 1527 infertile women (4381 cycles with polycystic ovarian syndrome (PCOS (n=911/2573 cycles and unexplained infertility (n=616/1808 cycles were randomized into two groups. Group A received single dose of uFSH on D 3 of menstrual cycle along with clomiphene. Group B received clomiphene only for ovulation induction. We compared the pregnancy rate and miscarriage rate between two groups. Results: Group A had a pregnancy rate of 17% compared to 8.3% of Group B which was significantly higher (P=0.0001. The miscarriage rate was 11% in Group A and 10% in Group B which was not significant (P=0.99. Pregnancy rates in PCOS women were 22% in Group A and 9.3% in Group B which shows significantly higher pregnancy rate (P=0.0001 in anovulatory infertility. But in unexplained infertility, there was no significant difference in pregnancy rate between Group A (11% and Group B(6.3%. Miscarriage rates were 8.8% and 9.5% in Group A and Group B, respectively, in PCOS women and 14% and 13% in women with unexplained infertility. Conclusion: Addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II. Correction of unexplained infertility may need more than simple correction of possible subtle ovulatory effect.

  4. Prospective Evaluation to Establish a Dose Response for Clinical Oral Mucositis in Patients Undergoing Head-and-Neck Conformal Radiotherapy

    International Nuclear Information System (INIS)

    Narayan, Samir; Lehmann, Joerg; Coleman, Matthew A.; Vaughan, Andrew; Yang, Claus Chunli; Enepekides, Danny; Farwell, Gregory; Purdy, James A.; Laredo, Grace; Nolan, Kerry A.S.; Pearson, Francesca S.; Vijayakumar, Srinivasan

    2008-01-01

    Purpose: We conducted a clinical study to correlate oral cavity dose with clinical mucositis, perform in vivo dosimetry, and determine the feasibility of obtaining buccal mucosal cell samples in patients undergoing head-and-neck radiation therapy. The main objective is to establish a quantitative dose response for clinical oral mucositis. Methods and Materials: Twelve patients undergoing radiation therapy for head-and-neck cancer were prospectively studied. Four points were chosen in separate quadrants of the oral cavity. Calculated dose distributions were generated by using AcQPlan and Eclipse treatment planning systems. MOSFET dosimeters were used to measure dose at each sampled point. Each patient underwent buccal sampling for future RNA analysis before and after the first radiation treatment at the four selected points. Clinical and functional mucositis were assessed weekly according to National Cancer Institute Common Toxicity Criteria, Version 3. Results: Maximum and average doses for sampled sites ranged from 7.4-62.3 and 3.0-54.3 Gy, respectively. A cumulative point dose of 39.1 Gy resulted in mucositis for 3 weeks or longer. Mild severity (Grade ≤ 1) and short duration (≤1 week) of mucositis were found at cumulative point doses less than 32 Gy. Polymerase chain reaction consistently was able to detect basal levels of two known radiation responsive genes. Conclusions: In our sample, cumulative doses to the oral cavity of less than 32 Gy were associated with minimal acute mucositis. A dose greater than 39 Gy was associated with longer duration of mucositis. Our technique for sampling buccal mucosa yielded sufficient cells for RNA analysis using polymerase chain reaction

  5. INDUSTRIAL OCULAR TRAUMA- A CLINICAL AND EPIDEMIOLOGICAL PROFILE

    Directory of Open Access Journals (Sweden)

    Sahiba Bedi

    2017-05-01

    Full Text Available BACKGROUND Incidence of ocular injuries is on the rise and is the commonest cause of unilateral blindness. Some individuals are at increased risk of eye injury as a result of their occupation. MATERIALS AND METHODS Data was obtained from case files of the patients in the retrospective group. In the prospective group, a complete ophthalmological examination including fundus was done for each patient. A final visual outcome was recorded at the end of 3 months post trauma based on visual acuity. Settings and Design- This was a 1 year retrospective and 1 year prospective study done in the Department of Ophthalmology, CMC, Ludhiana. Statistical Analysis- The clinical data collected was analysed for frequencies and proportions. RESULTS The industries where ocular trauma was found to be highest were the metal industries (61.7% followed by automobile industries (19.1%. Textile and woollen industry accounted for 5.8% cases. Metal objects caused injury in 81.7% of the cases. CONCLUSION Injuries occurring in industries are severe and males in age group of 21-30 years are most vulnerable. In view of costly medical care required and loss of productivity, preventive measures must be taken to avoid such injuries.

  6. Content knowledge of prospective elementary school teacher for fractional concepts

    Science.gov (United States)

    Pattimukay, N.; Juniati, D.; Budiarto, M. T.

    2018-03-01

    The aim of this study was to describe the content knowledge especially the concept of fraction of prospective elementary school teacher. The purpose of this study is to describe the content knowledge, especially the concept of fraction of prospective elementary school teacher. The subject of the study was one of prospective elementary school teacher of Pattimura University. This research is qualitative research. Data were collected through the provision of tests to explore the knowledge content of primary school teacher candidates about fractional concepts. Then continued with qualitative data analysis. The results of this study are as follows: that the prospective primary school teacher defines fractions as part of the whole if an object is divided into equal parts, so that the part that has been divided is part of the whole. Furthermore, the prospective elementary school teacher understood the fractions as division shown in two ways, namely the prospective elementary school teacher understood the fraction as a division operation, the primary school teacher candidate interpreted the fraction as a division when an object is divided be part of the same. Meanwhile, the fraction as a ratio is interpreted as the relationship between a pair of numbers. Then, the denominations are interpreted as a ratio between the numerator and the denominator of the same value. The prospective elementary school teacher also understands fractions of value when simplifying fractions. Primary school teacher candidates understand the concept of fractional operations.

  7. Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design

    Energy Technology Data Exchange (ETDEWEB)

    Cortese, Bernardo, E-mail: bcortese@gmail.com [Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milano (Italy); Ielasi, Alfonso [Azienda Ospedaliera Bolognini, Seriate (Italy); Varricchio, Attilio [Ospedale Monaldi, Napoli (Italy); Tarantini, Giuseppe [Azienda Ospedaliera Universitaria, Padova (Italy); LaVecchia, Luigi [Azienda Ospedaliera San Bortolo, Vicenza (Italy); Pisano, Francesco [Ospedale Regionale, Aosta (Italy); Facchin, Michela [Ospedale di Este (Italy); Gistri, Roberto [Ospedale S. Andrea, La Spezia (Italy); D’Urbano, Maurizio [Ospedale di Magenta (Italy); Lucci, Valerio [Ospedale di Avezzano (Italy); Loi, Bruno [Azienda Ospedaliera Brotzu, Cagliari (Italy); Tumminello, Gabriele [Ospedale Cardinal Massaia, Asti (Italy); Colombo, Alessandro [Ospedale Sacco, Milano (Italy); Limbruno, Ugo [Ospedale della Misericordia, Grosseto (Italy); Nicolino, Annamaria [Ospedale Santa Corona, Pietra Ligure (Italy); Calzolari, Diego [Azienda Ospedaliera Ca Foncello, Treviso (Italy); Tognoni, Gianni [Centro di Ricerche Farmacologiche e Biomediche ' Mario Negri' , Milano (Italy); Defilippi, Gianfranco [Ospedale Cardinal Massaia, Asti (Italy); Buccheri, Dario [Azienda Ospedaliera Fatebenefratelli e Oftalmico, Milano (Italy); Tespili, Maurizio [Azienda Ospedaliera Bolognini, Seriate (Italy); and others

    2015-09-15

    Background: The Absorb™ BVS is a bioresorbable, everolimus-eluting scaffold approved and marketed for coronary use. Published data on long-term results after treatment are limited to a small number of patients, most of them with elective PCI of simple lesions. The importance of scaffold resorption is variably appreciated among cardiologists, and indications for use from health technology assessment bodies or guidelines are missing. Instruments are needed to collect, share and assess the experience being accumulated with this new device in several centres. Methods/Design: The BVS-RAI Registry is a spontaneous initiative of a group of Italian interventional cardiologists in cooperation with Centro di Ricerche Farmacologiche e Biomediche 'Mario Negri' Institute, and is not recipient of funding or benefits originating from the BVS manufacturer. It is a prospective registry with 5-year follow-up of all consecutive patients who have undergone successful implantation of 1 or more coronary BVS following the indications, techniques and protocols used in each of the participating institutions. Outcome measures are BVS target lesion failure within one year and device-oriented major adverse cardiac events within 5 years. The registry started in October 2012 and will extend enrolment throughout 2015, with the aim to include about 1000 patients. ClinicalTrials.gov identifier is CT02298413. Conclusions: The BVS-RAI Registry will contribute observational knowledge on the long-term safety and efficacy of the Absorb™ BVS as used in a number of Italian interventional centres in a broad spectrum of settings. Unrewarded and undirected consecutive patient enrolments are key-features of this observation, which is therefore likely to reflect common clinical practice in those centres. - Highlights: • prospective data collection of successful Absorb implantation; • expert Italian centers; • no restrictions for enrollment/no exclusion criteria; • clinical follow up;

  8. Clinical outcomes and response of patients applying topical therapy for pyoderma gangrenosum: A prospective cohort study.

    Science.gov (United States)

    Thomas, Kim S; Ormerod, Anthony D; Craig, Fiona E; Greenlaw, Nicola; Norrie, John; Mitchell, Eleanor; Mason, James M; Johnston, Graham A; Wahie, Shyamal; Williams, Hywel C

    2016-11-01

    Pyoderma gangrenosum (PG) is an uncommon dermatosis with a limited evidence base for treatment. We sought to estimate the effectiveness of topical therapies in the treatment of patients with PG. This was a prospective cohort study of UK secondary care patients with a clinical diagnosis of PG that was suitable for topical treatment (recruited between July 2009 and June 2012). Participants received topical therapy after normal clinical practice (primarily topical corticosteroids [classes I-III] and tacrolimus 0.03% or 0.1%). The primary outcome was speed of healing at 6 weeks. Secondary outcomes included the following: proportion healed by 6 months; time to healing; global assessment; inflammation; pain; quality of life; treatment failure; and recurrence. Sixty-six patients (22-85 years of age) were enrolled. Clobetasol propionate 0.05% was the most commonly prescribed therapy. Overall, 28 of 66 (43.8%) ulcers healed by 6 months. The median time to healing was 145 days (95% confidence interval, 96 days to ∞). Initial ulcer size was a significant predictor of time to healing (hazard ratio, 0.94 [95% confidence interval, 0.88-1.00); P = .043). Four patients (15%) had a recurrence. Our study did not include a randomized comparator. Topical therapy is potentially an effective first-line treatment for PG that avoids the possible side effects associated with systemic therapy. It remains unclear whether more severe disease will respond adequately to topical therapy alone. Crown Copyright © 2016. Published by Elsevier Inc. All rights reserved.

  9. [Clinical nursing manpower: development and future prospects].

    Science.gov (United States)

    Lin, Chiou-Fen; Kao, Ching-Chiu

    2014-04-01

    The significant changes in nursing manpower utilization in Taiwan over the past two decades are due in large part to the implementation of the National Health Insurance program and the rising need for long-term care. The changes have impacted clinical nursing manpower utilization in two important ways. Firstly, there has been a substantial increase in overall demand for nursing manpower. In particular, the need for clinical nurses has nearly quadrupled during this time period. Secondly, the level of difficulty involved in patient care has risen dramatically, with factors including increased disease severity and increased care quality expectations, among others. These changes, coupled with demands on nursing manpower imposed from other sectors, underpin and further exacerbate the problem of nursing manpower shortages throughout the healthcare system. To raise the quality of the nursing work environment, the Ministry of Health and Welfare (MOHW) brought together Taiwan's key professional nursing organizations to promote 10 care-reform strategies, establish the nursing-aid manpower system, and create the nursing classification system as an approach to effectively attract nurses to take positions in the medical system.

  10. The Sydney Triage to Admission Risk Tool (START): A prospective validation study.

    Science.gov (United States)

    Ebker-White, Anja A; Bein, Kendall J; Dinh, Michael M

    2018-02-08

    The present study aims to prospectively validate the Sydney Triage to Admission Risk Tool (START) to predict ED disposition. This was a prospective validation study at two metropolitan EDs in Sydney, Australia. Consecutive triage encounters were observed by a trained researcher and START scores calculated. The primary outcome was patient disposition (discharge or inpatient admission) from the ED. Multivariable logistic regression was used to estimate area under curve of receiver operator characteristic (AUC ROC) for START scores as well as START score in combination with other variables such as frailty, general practitioner referral, overcrowding and major medical comorbidities. There were 894 patients analysed during the study period. The START score when applied to the data had AUC ROC of 0.80 (95% CI 0.77-0.83). The inclusion of other clinical variables identified at triage did not improve the overall performance of the model with an AUC ROC of 0.81 (95% CI 0.78-0.84) in the present study. The overall performance of the START tool with respect to model discrimination and accuracy has been prospectively validated. Further clinical trials are required to test the clinical effectiveness of the tool in improving patient flow and overall ED performance. © 2018 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

  11. Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

    Science.gov (United States)

    Bordet, Régis; Lang, Marie; Dieu, Christelle; Billon, Nathalie; Duffet, Jean-Pierre

    2015-08-19

    A public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials. We performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe's attractiveness to industry-funded trials.

  12. Stroke presentation and outcome in developing countries: a prospective study in the Gambia.

    Science.gov (United States)

    Garbusinski, Johanne M; van der Sande, Marianne A B; Bartholome, Emmanuel J; Dramaix, Michèle; Gaye, Alieu; Coleman, Rosalind; Nyan, Ousman A; Walker, Richard W; McAdam, Keith P W J; Walraven, Gys E

    2005-07-01

    Despite increasing burden of stroke in Africa, prospective descriptive data are rare. Our objective was to describe, in The Gambia, the clinical outcome of stroke patients admitted to the Royal Victoria Teaching Hospital in the capital Banjul, to assess mortality and morbidity, and propose preventive and therapeutic measures. Prospective data were collected on consecutive patients older than 15 years old admitted between February 2000 and February 2001 with the diagnosis of nonsubarachnoid stroke. Risk factors, clinical characteristics, and social consequences were assessed using a modified National Institutes of Health Stroke Scale (mNIHSS), the Barthel Activity in Daily Living scale, the Siriraj score for subtypes, and the Bamford criteria for location/extension. Patients were followed-up at home up to 1 year after discharge. Ninety-one percent (148/162) of eligible patients were enrolled and followed-up. Hypertension and smoking were the most prevalent risk factors. Severity was high at admission, especially in women, and was strongly correlated to the outcome. mNIHSS and consciousness level on admission were strong predictors of the mortality risk. Swallowing difficulties at admission, fever, lung infection, and no aspirin treatment were, independently, risk factors for a lethal outcome susceptible to being addressed by treatment. Mortality was 41% in-hospital and 62% after 1 year. In survivors, autonomy levels improved over time. Drug compliance was poor. At home, family members provided care. Long-term socioeconomic and cultural activities were affected in most patients. Case-fatality was high compared with Western cohorts. Preventive measures can be developed. Rational treatment, in the absence of head imaging for initial assessment, requires adapted protocols. Providers should be trained, both at hospital and community levels.

  13. Clinical prospective evaluation of zirconia-based three-unit posterior fixed dental prostheses: Up-to ten-year results.

    Science.gov (United States)

    Ioannidis, Alexis; Bindl, Andreas

    2016-04-01

    Only a few studies exist, which assess the clinical long-term behavior of all-ceramic FDPs in the posterior region. The aim of the present prospective clinical study was to evaluate the clinical performance of posterior three-unit FDPs manufactured from Y-TZP after a service period up to 10 years. 55 patients received 59 three-unit FDPs in the posterior region of the maxilla or mandible. Abutment teeth were prepared and full-arch impressions were taken. Definitive casts were fabricated and optically scanned. Frameworks were fabricated with computer-aided design (CAD) and manufacturing (CAM) technology. Y-TZP frameworks were veneered and adhesively luted to the abutment teeth. Baseline and follow-up examinations (service time: ≥ 48 months) were recorded by applying modified United States Public Health Services (USPHS) rating criteria. Cumulative survival rate was analyzed with Kaplan-Meier. Percentage of biological and technical complication was calculated. Fifty-three patients with 57 FDPs attended the last follow-up visit and a mean observation period of the remaining was 6.3 ± 1.9 years was calculated. Biological complications occurred in 17.5%, technical complications in 28% of the FDPs. The 10-year cumulative survival rate amounted 85.0%. Three FDPs failed to survive, two due to a root fracture of the abutment tooth and one due to secondary caries. Three-unit FDPs made from Y-TZP, veneered with ceramic offer a treatment option with a high rate of chipping. However, the manufacturing processes nowadays are modified in order to avoid this complication. The results of the present investigation suggest that three-unit Y-TZP posterior FDPs may are a possible treatment option. However, a high rate of chipping can be expected. Copyright © 2016. Published by Elsevier Ltd.

  14. Safety of parenteral nutrition in newborns: Results from a nationwide prospective cohort study.

    Science.gov (United States)

    Lapillonne, Alexandre; Berleur, Marie-Pierre; Brasseur, Yvette; Calvez, Sophie

    2018-04-01

    Limited or delayed availability of parenteral nutrition (PN) solutions, as well as difficulties in ordering are often identified as reasons for non-compliance with international guidelines in newborns. This study aims at assessing the modality of use and safety of premixed standardized PN solutions in a nationwide prospective cohort of newborns treated in clinical practice. Two premixed fixed formulations with respective osmolarity of 715 and 790 mOsm/L specifically designed for neonates were made available throughout the country for clinical use from birth onwards. Descriptive data and modality of use were prospectively collected in a case report form, whereas all related and unrelated adverse events were recorded on a separate adverse event form. A total of 14,167 infants were prospectively included and 16,640 parenteral nutrition periods were analyzed. Mean age was 33 weeks of gestation, and mean weight was 2086 g. The majority of infants (81%) started the parenteral nutrition the first day of life or the day after. The route of parenteral nutrition delivery was peripheral in 47% of the parenteral nutrition periods. During the whole study, a total of 72 adverse events occurring in 68 infants were reported. Of these adverse events, 59 (0.37% of the nutrition periods), among which 19 serious adverse events, were reported as related to the parenteral nutrition solutions. The events related to parenteral nutrition solutions were general disorders and administration site conditions (n = 42 including 9 cases of cutaneous necrosis), and nutrition and metabolism disorders (n = 17). There was no case of thrombophlebitis. Six of the 19 serious events related to the parenteral nutrition solutions (32%) were due to the misuse of the infusion bag. These data support the concept that ready-to-use parenteral nutrition formulations can safely provide parenteral nutrition from birth onwards. They further support that parenteral solutions with an osmolarity up to 800

  15. Prospective audit of mandibular fractures at the Charlotte Maxeke ...

    African Journals Online (AJOL)

    Objective. This study was a prospective cross-sectional clinical audit of patients with mandibular fractures at the Charlotte Maxeke Johannesburg Academic Hospital. Methods. Between 1 March and 31 August 2004, patients with mandibular fractures seen by one clinician had their details recorded. Results. The female:male ...

  16. Psoriatic arthritis: An assessment of clinical, biochemical and ...

    African Journals Online (AJOL)

    , epidemiological, clinical and radiological studies of South African (SA) patients are scarce. Objectives. To assess clinical, biochemical and radiological features in a single-centre SA cohort. Methods. We conducted a prospective assessment ...

  17. Parental comprehension and satisfaction in informed consent in paediatric clinical trials: a prospective study on childhood leukaemia.

    Science.gov (United States)

    Chappuy, H; Baruchel, A; Leverger, G; Oudot, C; Brethon, B; Haouy, S; Auvrignon, A; Davous, D; Doz, F; Tréluyer, J M

    2010-10-01

    To evaluate the extent to which parents are satisfied with and understand the information they are given when their consent is sought for their child to participate in a phase III randomised clinical trial and the reasons for their decision. The authors carried out a prospective study. The authors included all parents whose consent was sought for their child to participate in the FRALLE 2000A protocol (acute lymphoblastic leukaemia) at two centres. The parents were questioned twice by a qualified psychologist using a semidirected interview, 1 and 6 months after consent was sought. 43 first interviews were carried out. All the parents declared they were satisfied with the explanations provided by the physician. 35 (81%) parents felt that the information provided with the request for consent was appropriate. Eight (19%) parents did not realise that their child had been included in a research protocol. 16 (39%) parents did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. The principal factor underlying their decision, as stated by 29 parents (67%), was confidence in the medical team. The parents signed consent forms without having fully understood all the elements specific to the experimental protocol. Rather, the parents based their decision on their confidence in the medical team, even when their child's life was at risk.

  18. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study.

    Science.gov (United States)

    Gautier, Jean-Francois; Martinez, Luc; Penfornis, Alfred; Eschwège, Eveline; Charpentier, Guillaume; Huret, Benoît; Madani, Suliya; Gourdy, Pierre

    2015-09-01

    The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA1c effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. Novo Nordisk A/S. ClinicalTrials.gov identifier, NCT01226966.

  19. 78 FR 42088 - Agency Information Collection Activities: Proposed Collection: Public Comment Request

    Science.gov (United States)

    2013-07-15

    .... The nation's 58 organ procurement organizations (OPOs), who already work with hospitals on clinical... Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to.... Information Collection Request Title: National Hospital Organ Donation Campaign's Activity Scorecard. OMB No...

  20. Clinical trial considerations on male contraception and collection of pregnancy information from female partners

    Directory of Open Access Journals (Sweden)

    Banholzer Maria

    2012-06-01

    Full Text Available Abstract Background There is little guidance regarding the risk of exposure of pregnant women/ women of childbearing potential to genotoxic or teratogenic compounds via vaginal dose delivered through seminal fluid during sexual intercourse. Method We summarize current thinking and provide clinical trial considerations for a consistent approach to contraception for males exposed to genotoxic and/or teratogenic compounds or to compounds of unknown teratogenicity, and for collection of pregnancy data from their female partners. Results Where toxicity testing demonstrates genotoxic potential, condom use is required during exposure and for 5 terminal plasma half-lives plus 74 days (one human spermatogenesis cycle to avoid conception. For non-genotoxic small molecules and immunoglobulins with unknown teratogenic potential or without a no observed adverse effect level (NOAEL from embryo-fetal development (EFD studies and no minimal anticipated biological effect level (MABEL, condom use is recommended for males with pregnant partner/female partner of childbearing potential. For teratogenic small molecules with estimated seminal fluid concentration and a margin between projected maternal area under the curve (AUC and NOAEL AUC from EFD studies of ≥300 (≥100 for immunoglobulins or in the absence of a NOAEL with a margin between MABEL plasma concentration and maternal Cmax of ≥300 (≥10 for immunoglobulins, condom use is not required. However, condom use is required for margins below the thresholds previously indicated. For small molecules with available seminal fluid concentrations, condom use is required if margins are Pregnancy data should be proactively collected if pregnancy occurs during the condom use period required for males exposed to first-in-class molecules or to molecules with a target/class shown to be teratogenic, embryotoxic or fetotoxic in human or preclinical experiments. Conclusion These recommendations, based on a precaution

  1. Uranium prospecting; La prospection de l'uranium

    Energy Technology Data Exchange (ETDEWEB)

    Roubault, M [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1955-07-01

    This report is an instruction book for uranium prospecting. It appeals to private prospecting. As prospecting is now a scientific and technical research, it cannot be done without preliminary studies. First of all, general prospecting methods are given with a recall of fundamental geologic data and some general principles which are common with all type of prospecting. The peculiarities of uranium prospecting are also presented and in particular the radioactivity property of uranium as well as the special aspect of uranium ores and the aspect of neighbouring ores. In a third part, a description of the different uranium ores is given and separated in two different categories: primary and secondary ores, according to the place of transformation, deep or near the crust surface respectively. In the first category, the primary ores include pitchblende, thorianite and rare uranium oxides as euxenite and fergusonite for example. In the second category, the secondary ores contain autunite and chalcolite for example. An exhaustive presentation of the geiger-Mueller counter is given with the presentation of its different components, its functioning and utilization and its maintenance. The radioactivity interpretation method is showed as well as the elaboration of a topographic map of the measured radioactivity. A brief presentation of other detection methods than geiger-Mueller counters is given: the measurement of fluorescence and a chemical test using the fluorescence properties of uranium salts. Finally, the main characteristics of uranium deposits are discussed. (M.P.)

  2. Higgs results and prospects at ATLAS

    International Nuclear Information System (INIS)

    Rosati, S.

    2015-01-01

    Highlights of a selection of the recent results of Run-1 measurements of the Higgs boson properties, with the ATLAS experiment at LHC, are presented. The results have been obtained with up to 25 fb −1 of proton-proton collisions at center of mass energy of 7 and 8TeV. Prospects in the field of Higgs properties measurements, with the data that will be collected at the future LHC runs, with up to 3000 fb −1 , are also discussed.

  3. Scientific Research Competencies of Prospective Teachers and their Attitu des toward Scientific Research

    Directory of Open Access Journals (Sweden)

    Hasan Hüseyin Şahan

    2015-09-01

    Full Text Available Present study has been constructed to determine scientific research competencies of prospective teachers and identify the extent of effect of prospective teachers’ attitudes toward scientific research and scientific research methods course on their research skills and attitudes towards research. This study has two dimensions: it is a descriptive study by virtue of identifying prospective teachers’ research skills and attitudes toward research, also an experimental study by virtue of determining the effect of scientificresearch methods course on prospective teachers’ skills and their attitudes toward research. In order to obtain the data related to identified sub-problems “Scale for Identifying Scientific Research Competencies” and “Scale for Identifying the Attitude toward Research” have been utilized. Data collection tools were applied to 445 prospective teachers. It has thus been concluded in this study that scientific research methods course had no significant effect in gaining scientific research competencies to prospective teachers and that this effect demonstrated no differentiation with respect to departments. On the other hand it has been explored that scientific research methods course had a negative effect onthe attitudes of prospective teachers toward research and that there was a differentiation to the disadvantage of prospective teachers studying at Primary Education Mathematics Teaching Department.

  4. The African Lupus Genetics Network (ALUGEN) registry: standardized, prospective follow-up studies in African patients with systemic lupus erythematosus.

    Science.gov (United States)

    Hodkinson, B; Mapiye, D; Jayne, D; Kalla, A; Tiffin, N; Okpechi, I

    2016-03-01

    The prevalence and severity of systemic lupus erythematosus (SLE) differs between ethnic groups and geographical regions. Although initially reported as rare, there is growing evidence that SLE is prevalent and runs a severe course in Africa. There is a paucity of prospective studies on African SLE patients. The African Lupus Genetics Network (ALUGEN) is a multicentred framework seeking to prospectively assess outcomes in SLE patients in Africa. Outcomes measured will be death, hospital admission, disease activity flares, and SLE-related damage. We will explore predictors for these outcomes including clinical, serological, socio-demographic, therapeutic and genetic factors. Further, we will investigate comorbidities and health-related quality of life amongst these patients. Data of patients recently (≤ 5 yrs) diagnosed with SLE will be collected at baseline and annual follow-up visits, and captured electronically. The ALUGEN project will facilitate standardized data capture for SLE cases in Africa, allowing participating centres to develop their own SLE registries, and enabling collaboration to enrich our understanding of inter-ethnic and regional variations in disease expression. Comprehensive, high-quality multi-ethnic data on African SLE patients will expand knowledge of the disease and inform clinical practice, in addition to augmenting research capacity and networking links and providing a platform for future biomarker and interventional studies. © The Author(s) 2015.

  5. Radiological input during paediatric multidisciplinary team meetings and its influence on clinical patient management.

    Science.gov (United States)

    Llewellyn-Jones, Glyn; Pereira, John

    2016-04-01

    There is little information about the role of the radiologist at multidisciplinary team meetings; in particular their influence on patient management. To evaluate the influence of radiologists on clinical patient management during multidisciplinary meetings. Prospective data were collected over a 5-week period from multidisciplinary team meetings across four paediatric clinical domains. Radiological input was recorded for each case discussion, including the type of influence and its potential effect on clinical patient management. One hundred and forty paediatric cases were reviewed. Radiological advice was requested from the radiologist for 25.7% (N = 36) of cases. In 17.9% (N = 25) this advice was judged to have influenced clinical patient management. There were two cases where new imaging findings were discovered. Radiologists influence clinical patient management during multidisciplinary team meetings primarily by providing differential diagnoses and guidance regarding future imaging, with respect to both the necessity and the modality. Occasionally, when imaging is reviewed at these meetings, new findings are discovered that impact on patient management. © 2016 The Royal Australian and New Zealand College of Radiologists.

  6. Immediate occlusal loading of NanoTite PREVAIL implants: a prospective 1-year clinical and radiographic study.

    Science.gov (United States)

    Ostman, Pär-Olov; Wennerberg, Ann; Albrektsson, Tomas

    2010-03-01

    Recently, a new implant surface texture, featuring application of nanometer-scale calcium phosphate has been shown to enhance early bone fixation and formation in preclinical studies and in human histomorphometric studies, which may be beneficial in immediate loading situations. The purpose of the present prospective clinical study was to, during 1 year, clinically and radiographically evaluate a nanometer scale surface modified implant placed for immediate loading of fixed prostheses in both maxillary and mandibular regions. Thirty-five out of 38 patients who needed implant treatment and met inclusion criteria agreed to participate in the study and were consecutively enrolled. Surgical implant placement requirements consisted of a final torque of a least 25 Ncm prior to final seating and an implant stability quotient above 55. A total of 102 NanoTite PREVAIL (NTP) implants (BIOMET 3i, Palm Beach Gardens, FL, USA) (66 maxillary and 36 mandibular) were placed by one investigator, and the majority of these were placed in posterior regions (65%) and in soft bone (69%). A total of 44 prosthetic constructions were evaluated consisting of 14 single-tooth restorations, 26 fixed partial dentures, and four complete fixed restorations. All provisional constructions were delivered within 1 hour, and the final constructions placed after 4 months. Implants were monitored for clinical and radiographic outcomes at follow-up examinations scheduled for 3, 6, and 12 months. Of the 102 study implants, one implant failed. The simple cumulative survival rate value at 1 year was 99.2%. The average marginal bone resorption was 0.37 mm (SD 0.39) during the first year in function. According to the success criteria of Albrektsson and Zarb, success grade 1 was found with 93% of the implants. Although limited to the short follow-up, immediate loading of NanoTite Prevail implants seems to be a viable option in implant rehabilitation, at least when a good initial fixation is achieved.

  7. Hand trauma: A prospective observational study reporting diagnostic concordance in emergency hand trauma which supports centralised service improvements.

    Science.gov (United States)

    Miranda, B H; Spilsbury, Z P; Rosala-Hallas, A; Cerovac, S

    2016-10-01

    Hand injuries are common, contributing up to 30% of accident and emergency (A&E) attendances. The aim of this study was to prospectively analyse the pathological demographics of hand injuries in a level 1 trauma centre with a Hand Trauma Unit and direct A&E links, and compare clinical and intra-operative findings. The null hypothesis was that there would be no differences between clinical and intra-operative findings (100% diagnostic concordance). Data were prospectively collected for referrals during 2012. Referral diagnosis, additional pathologies found on clinical assessment and intra-operative findings were documented on a live database accessible from both the Hand Unit and associated operating theatres. Odds ratios were calculated using SAS. Injuries (1526) were identified in 1308 patients included in the study. Diagnostic concordance between Hand Unit clinical examination and intra-operative findings was 92.5% ± 2.85% (mean ± SEM); this was lower for flexor tendon injuries (56.3%) because a greater number of additional pathologies were found intra-operatively (2.25 ± 0.10). This 'trend' was noted across multiple referral pathologies including phalangeal fractures (1.28 ± 0.02; 82.9%), lacerations (1.33 ± 0.04; 79.1%), extensor tendon injuries (1.30 ± 0.05; 87.8%) and dislocations (1.18 ± 0.05; 87.8%). Odds ratio analysis indicated a relationship between primary referral diagnoses that were more or less likely to be associated with additional injuries (p management of hand trauma. Our findings, coupled with the presented relevant literature reports, lead us to advocate that A&E departments should move towards a system wherein links to specialist hand trauma services are in place; we hereby present useful data for hospitals implementing such services. Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

  8. Therapeutic horticulture in clinical depression: a prospective study.

    Science.gov (United States)

    Gonzalez, Marianne Thorsen; Hartig, Terry; Patil, Grete Grindal; Martinsen, Egil W; Kirkevold, Marit

    2009-01-01

    Clinically depressed persons suffer from impaired mood and distortion of cognition. This study assessed changes in depression severity and perceived attentional capacity of clinically depressed adults (N=18) during a 12-week therapeutic horticulture program. The Beck Depression Inventory (BDI) and Attentional Function Index (AFI) were administered at baseline, twice during (4 and 8 weeks), and immediately after the intervention (12 weeks), and at a 3-month follow-up. Experiences of being away and fascination related to the intervention were measured at 4, 8, and 12 weeks. The mean BDI score declined 9.7 points from pretest (27.3) to posttest (p or =6) for 72% of the cases. The mean AFI score increased 10.2 points from pretest (68.8) to posttest (p = .06). The greatest change in BDI and AFI scores occurred in the initial weeks of the intervention. The reduction in BDI scores remained significant and clinically relevant at the 3-month follow-up (N=16). The decline in depression severity during the intervention correlated strongly with the degree to which the participants found that it captured their attention. Therapeutic horticulture may decrease depression severity and improve perceived attentional capacity by engaging effortless attention and interrupting rumination.

  9. [Research Progress and Prospect of Applications of Finite Element Method in Lumbar Spine Biomechanics].

    Science.gov (United States)

    Zhang, Zhenjun; Li, Yang; Liao, Zhenhua; Liu, Weiqiang

    2016-12-01

    Based on the application of finite element analysis in spine biomechanics,the research progress of finite element method applied in lumbar spine mechanics is reviewed and the prospect is forecasted.The related works,including lumbar ontology modeling,clinical application research,and occupational injury and protection,are summarized.The main research areas of finite element method are as follows:new accurate modeling process,the optimized simulation method,diversified clinical effect evaluation,and the clinical application of artificial lumbar disc.According to the recent research progress,the application prospects of finite element method,such as automation and individuation of modeling process,evaluation and analysis of new operation methods and simulation of mechanical damage and dynamic response,are discussed.The purpose of this paper is to provide the theoretical reference and practical guidance for the clinical lumbar problems by reviewing the application of finite element method in the field of the lumbar spine biomechanics.

  10. ISABELLE [Intersecting Storage Accelerators with the adjective belle] physics prospects

    International Nuclear Information System (INIS)

    1972-01-01

    This volume contains a collection of reports on physics prospects at a 200 x 200-GeV proton intersecting storage ring facility (Isabelle or ISA). General topics of papers included are: machine-related topics, general purpose detectors, strong interaction experiments, weak and electromagnetic interaction experiments, and other exotic ideas

  11. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY PROTOCOL FOR STANDARDIZED PRODUCTION OF CLINICAL PRACTICE GUIDELINES, ALGORITHMS, AND CHECKLISTS - 2017 UPDATE.

    Science.gov (United States)

    Mechanick, Jeffrey I; Pessah-Pollack, Rachel; Camacho, Pauline; Correa, Ricardo; Figaro, M Kathleen; Garber, Jeffrey R; Jasim, Sina; Pantalone, Kevin M; Trence, Dace; Upala, Sikarin

    2017-08-01

    Clinical practice guideline (CPG), clinical practice algorithm (CPA), and clinical checklist (CC, collectively CPGAC) development is a high priority of the American Association of Clinical Endocrinologists (AACE) and American College of Endocrinology (ACE). This 2017 update in CPG development consists of (1) a paradigm change wherein first, environmental scans identify important clinical issues and needs, second, CPA construction focuses on these clinical issues and needs, and third, CPG provide CPA node/edge-specific scientific substantiation and appended CC; (2) inclusion of new technical semantic and numerical descriptors for evidence types, subjective factors, and qualifiers; and (3) incorporation of patient-centered care components such as economics and transcultural adaptations, as well as implementation, validation, and evaluation strategies. This third point highlights the dominating factors of personal finances, governmental influences, and third-party payer dictates on CPGAC implementation, which ultimately impact CPGAC development. The AACE/ACE guidelines for the CPGAC program is a successful and ongoing iterative exercise to optimize endocrine care in a changing and challenging healthcare environment. AACE = American Association of Clinical Endocrinologists ACC = American College of Cardiology ACE = American College of Endocrinology ASeRT = ACE Scientific Referencing Team BEL = best evidence level CC = clinical checklist CPA = clinical practice algorithm CPG = clinical practice guideline CPGAC = clinical practice guideline, algorithm, and checklist EBM = evidence-based medicine EHR = electronic health record EL = evidence level G4GAC = Guidelines for Guidelines, Algorithms, and Checklists GAC = guidelines, algorithms, and checklists HCP = healthcare professional(s) POEMS = patient-oriented evidence that matters PRCT = prospective randomized controlled trial.

  12. Nursing Challenges in Motivating Nursing Students through Clinical Education: A Grounded Theory Study.

    Science.gov (United States)

    Nasrin, Hanifi; Soroor, Parvizy; Soodabeh, Joolaee

    2012-01-01

    Nurses are the first role models for students in clinical settings. They can have a significant role on students' motivation. The purpose of this study was to explore the understanding of nursing students and instructors concerning the role of nurses in motivating nursing students through clinical education. The sampling was first started purposefully and continued with theoretical sampling. The study collected qualitative data through semistructured and interactive interviews with 16 nursing students and 4 nursing instructors. All interviews were recorded, transcribed, and analyzed using grounded theory approach. One important pattern emerged in this study was the "concerns of becoming a nurse," which itself consisted of three categories: "nurses clinical competency," "nurses as full-scale mirror of the future," and "Monitoring and modeling through clinical education" (as the core variable). The findings showed that the nurses' manners of performance as well as the profession's prospect have a fundamental role in the process of formation of motivation through clinical education. Students find an insight into the nursing profession by substituting themselves in the place of a nurse, and as result, are or are not motivated towards the clinical education.

  13. In Defense of a Social Value Requirement for Clinical Research.

    Science.gov (United States)

    Wendler, David; Rid, Annette

    2017-02-01

    Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

  14. Assessment of hospital pharmacists' clinical knowledge and ...

    African Journals Online (AJOL)

    Purpose: To evaluate hospital pharmacists' clinical knowledge and practical skill levels for pharmaceutical care. Methods: A quasi-experimental prospective longitudinal study design was used to evaluate the level of clinical skills with problem-based learning (PBL) sessions. Pharmacists' in three different government ...

  15. Translating Stem Cell Research to Cardiac Disease Therapies: Pitfalls and Prospects for Improvement

    Science.gov (United States)

    Rosen, Michael R.; Myerburg, Robert J.; Francis, Darrel P.; Cole, Graham D.; Marbán, Eduardo

    2014-01-01

    Over the past 2 decades, there have been numerous stem cell studies focused on cardiac diseases, ranging from proof-of-concept to phase 2 trials. This series of articles focuses on the legacy of these studies and the outlook for future treatment of cardiac diseases with stem cell therapies. The first section by Rosen and Myerburg is an independent review that analyzes the basic science and translational strategies supporting the rapid advance of stem cell technology to the clinic, the philosophies behind them, trial designs, and means for going forward that may impact favorably on progress. The second and third sections were collected in response to the initial section of this review. The commentary by Francis and Cole discusses the Rosen and Myerburg review and details how trial outcomes can be affected by noise, poor trial design (particularly the absence of blinding), and normal human tendencies toward optimism and denial. The final, independent article by Marbán takes a different perspective concerning the potential for positive impact of stem cell research applied to heart disease and future prospects for its clinical application. PMID:25169179

  16. Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

    Science.gov (United States)

    Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B

    2018-03-01

    The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

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

    Science.gov (United States)

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

    2011-09-01

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

  18. Intraoperative discomfort associated with the use of a rotary or reciprocating system: a prospective randomized clinical

    Directory of Open Access Journals (Sweden)

    Aline Cristine Gomes

    2017-05-01

    Full Text Available Objectives The aim of this randomized, controlled, prospective clinical study was to evaluate patients' intraoperative discomfort during root canal preparations in which either multi-file rotary (Mtwo or single-file reciprocating (Reciproc systems were used. Materials and Methods Fifty-five adult patients, aged between 25 and 69 years old, with irreversible pulpitis or pulp necrosis participated in this study. Either the mesiobuccal or the distobuccal canals for maxillary molars and either the mesiobuccal or the mesiolingual canals for mandibular molars were randomly chosen to be instrumented with Mtwo multi-file rotary or Reciproc single-file reciprocating systems. Immediately after each canal instrumentation under anesthesia, patient discomfort was assessed using a 1 - 10 visual analog scale (VAS, ranging from ‘least possible discomfort’ (1 to ‘greatest possible discomfort’ (10. The Wilcoxon signed-rank test was used to determine significant differences at p< 0.05. Results Little intraoperative discomfort was found in all cases. No statistically significant differences in intraoperative discomfort between the 2 systems were found (p = 0.660. Conclusions Root canal preparation with multi-file rotary or single-file reciprocating systems had similar and minimal effects on patients' intraoperative discomfort.

  19. Vaginal tampons as specimen collection device for the molecular diagnosis of non-ulcerative sexually transmitted infections in antenatal clinic attendees.

    NARCIS (Netherlands)

    Sturm, P.D.J.; Connolly, C.E.; Khan, N.; Ebrahim, S.; Sturm, A.W.

    2004-01-01

    Self-inserted vaginal tampons for the molecular diagnosis of non-ulcerative STIs were evaluated. Cervical and vaginal swabs, tampons and urines were collected from 185 first-time antenatal clinic attendees. Cultures and nucleic acid amplification assays (NAA) were performed. The sensitivity of PCR

  20. Clinical leadership development and education for nurses: prospects and opportunities

    Directory of Open Access Journals (Sweden)

    Joseph ML

    2015-07-01

    Full Text Available M Lindell Joseph, Diane L Huber College of Nursing, The University of Iowa, Iowa City, IA, USA Abstract: With the implementation of the Affordable Care Act, elevated roles for nurses of care coordinator, clinical nurse leader, and advanced practice registered nurse have come to the forefront. Because change occurs so fast, matching development and education to job requirements is a challenging forecasting endeavor. The purpose of this article is to envision clinical leadership development and education opportunities for three emerging roles. The adoption of a common framework for intentional leadership development is proposed for clinical leadership development across the continuum of care. Solutions of innovation and interdependency are framed as core concepts that serve as an opportunity to better inform clinical leadership development and education. Additionally, strategies are proposed to advance knowledge, skills, and abilities for crucial implementation of improvements and new solutions at the point of care. Keywords: clinical leadership, nursing leadership, CNL, care coordination, innovation, interdependency

  1. The international dosimetry exchange for BNCT. A basis for pooling and collectively analyzing clinical results

    International Nuclear Information System (INIS)

    Riley, K.J.; Binns, P.J.; Harling, O.K.; Kiger, W.S. III; Seppaelae, T.; Savolainen, S.; Moss, R.; Marek, M.; Rezaei, A.

    2006-01-01

    An international collaboration was organized by the Massachusetts Institute of Technology (MIT) to undertake a dosimetry exchange for the eventual purpose of combining results from various clinical centers that employ different methods for measuring and prescribing absorbed dose in the mixed radiation fields used for neutron capture therapy. Treatment plans calculated at NCT centers in the Czech Republic, Finland, The Netherlands and Sweden were normalized to corresponding measurements performed by the MIT dosimetry group in each beam. More than half of the normalizations for individual absorbed dose components (photon, fast neutron, thermal neutron and boron) determined by comparing MIT measurements to the dose specified in treatment plans from the different centers were statistically significant and ranged from 8 to 400%. Each facility had at least one dose component that would require normalization for the specified doses to be accurately compared. These normalizations establish a technical basis to begin collectively analyzing treatment plans between the European and US centers. Simple but pertinent treatment parameters such as the maximum dose to brain can now be properly compared, once the clinical data is available. This could held to more precisely and quickly determine various dose-response relationships as for example those related to adverse events. Future efforts to determine dose normalization at other centers performing human studies as well as more sophisticated analyses using combined data from several centers should be guided by clearly defined clinical objectives with active participation from clinical BNCT experts. (author)

  2. Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain

    Directory of Open Access Journals (Sweden)

    Tropp Hans

    2005-06-01

    Full Text Available Abstract Background The tissue origin of low back pain (LBP or referred lower extremity symptoms (LES may be identified in about 70% of cases using advanced imaging, discography and facet or sacroiliac joint blocks. These techniques are invasive and availability varies. A clinical examination is non-invasive and widely available but its validity is questioned. Diagnostic studies usually examine single tests in relation to single reference standards, yet in clinical practice, clinicians use multiple tests and select from a range of possible diagnoses. There is a need for studies that evaluate the diagnostic performance of clinical diagnoses against available reference standards. Methods We compared blinded clinical diagnoses with diagnoses based on available reference standards for known causes of LBP or LES such as discography, facet, sacroiliac or hip joint blocks, epidurals injections, advanced imaging studies or any combination of these tests. A prospective, blinded validity design was employed. Physiotherapists examined consecutive patients with chronic lumbopelvic pain and/or referred LES scheduled to receive the reference standard examinations. When diagnoses were in complete agreement regardless of complexity, "exact" agreement was recorded. When the clinical diagnosis was included within the reference standard diagnoses, "clinical agreement" was recorded. The proportional chance criterion (PCC statistic was used to estimate agreement on multiple diagnostic possibilities because it accounts for the prevalence of individual categories in the sample. The kappa statistic was used to estimate agreement on six pathoanatomic diagnoses. Results In a sample of chronic LBP patients (n = 216 with high levels of disability and distress, 67% received a patho-anatomic diagnosis based on available reference standards, and 10% had more than one tissue origin of pain identified. For 27 diagnostic categories and combinations, chance clinical agreement

  3. The first pharmacist-managed anticoagulation clinic under a collaborative practice agreement in Qatar: clinical and patient-oriented outcomes.

    Science.gov (United States)

    Elewa, H F; AbdelSamad, O; Elmubark, A E; Al-Taweel, H M; Mohamed, A; Kheir, N; Mohamed Ibrahim, M I; Awaisu, A

    2016-08-01

    Optimal outpatient anticoagulation management requires a systematic and coordinated approach. Extensive evidence regarding the benefits of pharmacist-managed anticoagulation services has been reported in the literature. The quality and outcomes associated with pharmacist-managed anticoagulation clinics under collaborative practice agreements in the Middle East have rarely been reported. The first pharmacist-managed ambulatory anticoagulation clinic in Qatar was launched at Al-Wakrah Hospital in March 2013. The objectives of this study were to: (i) describe the practice model of the clinic, (ii) evaluate the quality of the clinic [i.e. the time in therapeutic range (TTR)] and the clinical outcomes (i.e. the efficacy and safety), and (iii) determine the patients' satisfaction and overall quality of life (QoL). Clinical outcome data were collected through a retrospective chart review of all patients managed from March 2013 to October 2014 at the pharmacist-managed anticoagulation clinic. Furthermore, the patient-oriented outcomes data were prospectively collected using the 24-item Duke Anticoagulation Satisfaction Scale (DASS). Each item was assessed using a 7-point Likert-type scale on which lower scores indicated better QoL and greater satisfaction. The clinical outcome data analyses included 119 patients who were enrolled at the clinic during the 19-month study period. The mean number of international normalized ratio (INR) tests/month was 65 ± 9, the average testing frequency was 2·7 ± 1·6 weeks, and the average %TTR was 76·8 ± 22·9%. There was one major bleeding event (0·67%/year), 12 minor bleeding events (8%/year) and two thromboembolic events (1·35%/year) recorded during the study period. Of the 119 patients, 50 participated in the satisfaction and QoL survey. The median (IQR) total QoL score of these subjects was 63 (48) (minimum-maximum achievable score: 24-168). Seventy-six per cent of the patients indicated 'a lot to very much' in terms of their

  4. Filariasis attenuates anemia and proinflammatory responses associated with clinical malaria: a matched prospective study in children and young adults.

    Directory of Open Access Journals (Sweden)

    Housseini Dolo

    Full Text Available Wuchereria bancrofti (Wb and Mansonella perstans (Mp are blood-borne filarial parasites that are endemic in many countries of Africa, including Mali. The geographic distribution of Wb and Mp overlaps considerably with that of malaria, and coinfection is common. Although chronic filarial infection has been shown to alter immune responses to malaria parasites, its effect on clinical and immunologic responses in acute malaria is unknown.To address this question, 31 filaria-positive (FIL+ and 31 filaria-negative (FIL- children and young adults, matched for age, gender and hemoglobin type, were followed prospectively through a malaria transmission season. Filarial infection was defined by the presence of Wb or Mp microfilariae on calibrated thick smears performed between 10 pm and 2 am and/or by the presence of circulating filarial antigen in serum. Clinical malaria was defined as axillary temperature ≥37.5°C or another symptom or sign compatible with malaria infection plus the presence of asexual malaria parasites on a thick blood smear. Although the incidence of clinical malaria, time to first episode, clinical signs and symptoms, and malaria parasitemia were comparable between the two groups, geometric mean hemoglobin levels were significantly decreased in FIL- subjects at the height of the transmission season compared to FIL+ subjects (11.4 g/dL vs. 12.5 g/dL, p<0.01. Plasma levels of IL-1ra, IP-10 and IL-8 were significantly decreased in FIL+ subjects at the time of presentation with clinical malaria (99, 2145 and 49 pg/ml, respectively as compared to 474, 5522 and 247 pg/ml in FIL- subjects.These data suggest that pre-existent filarial infection attenuates immune responses associated with severe malaria and protects against anemia, but has little effect on susceptibility to or severity of acute malaria infection. The apparent protective effect of filarial infection against anemia is intriguing and warrants further study in a larger cohort.

  5. Predicting survival time in noncurative patients with advanced cancer: a prospective study in China.

    Science.gov (United States)

    Cui, Jing; Zhou, Lingjun; Wee, B; Shen, Fengping; Ma, Xiuqiang; Zhao, Jijun

    2014-05-01

    Accurate prediction of prognosis for cancer patients is important for good clinical decision making in therapeutic and care strategies. The application of prognostic tools and indicators could improve prediction accuracy. This study aimed to develop a new prognostic scale to predict survival time of advanced cancer patients in China. We prospectively collected items that we anticipated might influence survival time of advanced cancer patients. Participants were recruited from 12 hospitals in Shanghai, China. We collected data including demographic information, clinical symptoms and signs, and biochemical test results. Log-rank tests, Cox regression, and linear regression were performed to develop a prognostic scale. Three hundred twenty patients with advanced cancer were recruited. Fourteen prognostic factors were included in the prognostic scale: Karnofsky Performance Scale (KPS) score, pain, ascites, hydrothorax, edema, delirium, cachexia, white blood cell (WBC) count, hemoglobin, sodium, total bilirubin, direct bilirubin, aspartate aminotransferase (AST), and alkaline phosphatase (ALP) values. The score was calculated by summing the partial scores, ranging from 0 to 30. When using the cutoff points of 7-day, 30-day, 90-day, and 180-day survival time, the scores were calculated as 12, 10, 8, and 6, respectively. We propose a new prognostic scale including KPS, pain, ascites, hydrothorax, edema, delirium, cachexia, WBC count, hemoglobin, sodium, total bilirubin, direct bilirubin, AST, and ALP values, which may help guide physicians in predicting the likely survival time of cancer patients more accurately. More studies are needed to validate this scale in the future.

  6. Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform.

    Science.gov (United States)

    Sivaramakrishnan, Gowri; Sridharan, Kannan

    2016-06-01

    Clinical trials are the back bone for evidence-based practice (EBP) and recently EBP has been considered the best source of treatment strategies available. Clinical trial registries serve as databases of clinical trials. As regards to dentistry in specific data on the number of clinical trials and their quality is lacking. Hence, the present study was envisaged. Clinical trials registered in WHO-ICTRP (http://apps.who.int/trialsearch/AdvSearch.aspx) in dental specialties were considered. The details assessed from the collected trials include: Type of sponsors; Health condition; Recruitment status; Study design; randomization, method of randomization and allocation concealment; Single or multi-centric; Retrospective or prospective registration; and Publication status in case of completed studies. A total of 197 trials were identified. Maximum trials were from United States (n = 30) and United Kingdom (n = 38). Seventy six trials were registered in Clinical Trials.gov, 54 from International Standards of Reporting Clinical Trials, 13 each from Australia and New Zealand Trial Register and Iranian Registry of Clinical Trials, 10 from German Clinical Trial Registry, eight each from Brazilian Clinical Trial Registry and Nederland's Trial Register, seven from Japan Clinical Trial Registry, six from Clinical Trial Registry of India and two from Hong Kong Clinical Trial Registry. A total of 78.7% studies were investigator-initiated and 64% were completed while 3% were terminated. Nearly four-fifths of the registered trials (81.7%) were interventional studies of which randomized were the large majority (94.4%) with 63.2% being open label, 20.4% using single blinding technique and 16.4% were doubled blinded. The number, methodology and the characteristics of clinical trials in dentistry have been noted to be poor especially in terms of being conducted multi-centrically, employing blinding and the method for randomization and allocation concealment. More emphasis has to be

  7. Quality assurance of radiotherapy and its clinical assessment

    International Nuclear Information System (INIS)

    Inoue, Toshihiko

    2002-01-01

    We investigated the clinical quality assurance (QA) of radiotherapy in Japan since 1981. The aim of this study was to establish the QA of a radiotherapy system and its clinical assessment in Japan. We introduced the Patterns of Care Study (PCS) into Japan to perform this study in 1996. The PCS is a retrospective study designed to establish the national practice for cancer patients during a specific period and should be a complementary study to a prospective randomized controlled study. We collected precise data for 4399 patients with carcinomas of the breast, cervix, esophagus, lung and prostate by means of external audits for 96 institutes from 1998 through 2001. Patients were randomly sampled with two-stage cluster sampling. We stratified 556 institutes into four categories according to the academic condition and annual number of radiotherapy patients. National and regional averages of various factors of radiotherapy could be calculated and were used to measure QA of radiotherapy. Using a standard score, we could compare the process of individual institutions with national averages and feed back the evaluation score to each institution. With a PCS process survey, we could observe the dissemination of the treatment method under evidence-based medicine from the prospective randomized controlled study. We proposed future prediction of the number of radiotherapy patients and a counter plan for equipment and personnel. The first US-Japan PCS Workshop was held at San Francisco in 2001. We could establish QA of a radiotherapy system using PCS 1995-97 in Japan. (author)

  8. Prospective validation of a blood-based 9-miRNA profile for early detection of breast cancer in a cohort of women examined by clinical mammography

    DEFF Research Database (Denmark)

    Lyng, Maria B; Kodahl, Annette R; Binder, Harald

    2016-01-01

    developed a 9-miRNA profile using serum and LNA-based qPCR that effectively stratified patients with early stage breast cancer vs. healthy women. To further develop the test into routine clinical practice, we collected serum of women examined by clinical mammography (N = 197) according to standard...... is significantly different between women with breast cancer and controls (p-value within one year despite being categorized as clinically healthy...

  9. Predictors of clinical complications in patients with spinomedullary injury

    Directory of Open Access Journals (Sweden)

    Dionei Freitas De Morais

    2014-01-01

    Full Text Available Objective: To analyze individuals with spinal cord injury who developed secondary clinical complications, and the variables that can influence the prognosis. Methods: A prospective study of 321 patients with spinal cord injury. The variables were collected: age, sex, cause of the accident, anatomical distribution, neurological status, associated injuries, in-hospital complications, and mortality only in patients who developed complications. Results: A total of 72 patients were analyzed (85% male with a mean age of 44.72±19.19 years. The individuals with spinal cord injury who developed clinical complications were mostly male, over 50 years of age, and the main cause was accidental falls. These patients had longer hospitalization times and a higher risk of progressing to death. Pneumonia was the main clinical complication. With regard to the variables that can influence the prognosis of these patients, it was observed that spinal cord injury to the cervical segment with syndromic quadriplegia, and neurological status ASIA-A, have a higher risk of developing pneumonia, the most common complication, as well as increased mortality. Conclusion: Clinical complications secondary to spinal cord injury are influenced by demographic factors, as well as characteristics of the injury contributing to an increase in mortality.

  10. Clinical manifestations and outcome in Staphylococcus aureus endocarditis among injection drug users and nonaddicts: a prospective study of 74 patients

    Directory of Open Access Journals (Sweden)

    Ruotsalainen Eeva

    2006-09-01

    Full Text Available Abstract Background Endocarditis is a common complication in Staphylococcus aureus bacteremia (SAB. We compared risk factors, clinical manifestations, and outcome in a large, prospective cohort of patients with S. aureus endocarditis in injection drug users (IDUs and in nonaddicts. Methods Four hundred and thirty consecutive adult patients with SAB were prospectively followed up for 3 months. Definite or possible endocarditis by modified Duke criteria was found in 74 patients: 20 patients were IDUs and 54 nonaddicts. Results Endocarditis was more common in SAB among drug abusers (46% than in nonaddicts (14% (odds ratio [OR], 5.12; 95% confidence interval [CI], 2.65–9.91; P P P P = 0.03, and their SAB was more often community-acquired (95% vs 39%, P P P = 0.70. Arterial thromboembolic events and severe sepsis were also equally common in both groups. There was no difference in mortality between the groups at 7 days, but at 3 months it was lower among IDUs (10% compared with nonaddicts (39% (OR, 5.73; 95% CI, 1.20–27.25; P = 0.02. Conclusion S. aureus endocarditis in IDUs was associated with as high complication rates including extracardiac deep infections, thromboembolic events, or severe sepsis as in nonaddicts. Injection drug abuse in accordance with younger age and lack of underlying diseases were associated with lower mortality, but after adjusting by age and underlying diseases injection drug abuse was not significantly associated with mortality.

  11. KDIGO 2012 Clinical Practice Guideline CKD classification rules out creatinine clearance 24 hour urine collection?

    Science.gov (United States)

    Ognibene, A; Grandi, G; Lorubbio, M; Rapi, S; Salvadori, B; Terreni, A; Veroni, F

    2016-01-01

    The recent guideline for the evaluation and management of Chronic Kidney Disease recommends assessing GFR employing equations based on serum creatinine; despite this, creatinine clearance 24-hour urine collection is used routinely in many settings. In this study we compared the classification assessed from CrCl (creatinine clearance 24h urine collection) and e-GFR calculated with CKD-EPI or MDRD formulas. In this retrospective study we analyze consecutive laboratory data: creatinine clearance 24h urine collection, serum creatinine and demographic data such as sex and age from 15,777 patients >18 years of age collected from 2011 to 2013 in our laboratory at Careggi Hospital. The results were then compared to the estimated GFR calculated with the equations according to the recent treatment guidelines. Consecutive and retrospective laboratory data (creatinine clearance 24h urine collection, serum creatinine and, demographic data such as sex and age) from 15,777 patients >18 years of age seen at Careggi Hospital were collected. Comparison between e-GFR calculated with CKD-EPI or MDRD formulas and GFR according CrCl determinations and bias [95% CI] were 11.34 [-47,4/70.1] and 11.4 [-50.2/73] respectively. The concordance for 18/65 years aged group when compared with e-GFR classification between MDRD vs CKDEPI, MDRD vs CrCl and CKD-EPI vs CrCl were 0.78, 0.34, and 0.41 respectively, while in the 65/110years aged group the concordance Kappas were 0.84, 0.38, and 0.36 respectively. The use of CrCl provides a different classification than the estimation of GFR using a prediction equation. The CrCl is unreliable when it is necessary to identify CKD subjects with decrease of GFR of 5ml/min/1.73m(2)/year. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

  12. Biomarkers in Scleroderma: Progressing from Association to Clinical Utility.

    Science.gov (United States)

    Ligon, Colin; Hummers, Laura K

    2016-03-01

    Scleroderma is a heterogenous disease characterized by autoimmunity, a characteristic vasculopathy, and often widely varying extents of deep organ fibrosis. Recent advances in the understanding of scleroderma's evolution have improved the ability to identify subgroups of patients with similar prognosis in order to improve risk stratification, enrich clinical trials for patients likely to benefit from specific therapies, and identify promising therapeutic targets for intervention. High-throughput technologies have recently identified fibrotic and inflammatory effectors in scleroderma that exhibit strong prognostic ability and may be tied to disease evolution. Increasingly, the use of collections of assayed circulating proteins and patterns of gene expression in tissue has replaced single-marker investigations in understanding the evolution of scleroderma and in objectively characterizing disease extent. Lastly, identification of shared patterns of disease evolution has allowed classification of patients into latent disease subtypes, which may allow rapid clinical prognostication and targeted management in both clinical and research settings. The concept of biomarkers in scleroderma is expanding to include nontraditional measures of aggregate protein signatures and disease evolution. This review examines the recent advances in biomarkers with a focus on those approaches poised to guide prospective management or themselves serve as quantitative surrogate disease outcomes.

  13. Profiling sirolimus-induced inflammatory syndrome: a prospective tricentric observational study.

    Directory of Open Access Journals (Sweden)

    Fanny Buron

    Full Text Available BACKGROUND: The use of the immunosuppressant sirolimus in kidney transplantation has been made problematic by the frequent occurrence of various side effects, including paradoxical inflammatory manifestations, the pathophysiology of which has remained elusive. METHODS: 30 kidney transplant recipients that required a switch from calcineurin inhibitor to sirolimus-based immunosuppression, were prospectively followed for 3 months. Inflammatory symptoms were quantified by the patients using visual analogue scales and serum samples were collected before, 15, 30, and 90 days after the switch. RESULTS: 66% of patients reported at least 1 inflammatory symptom, cutaneo-mucosal manifestations being the most frequent. Inflammatory symptoms were characterized by their lability and stochastic nature, each patient exhibiting a unique clinical presentation. The biochemical profile was more uniform with a drop of hemoglobin and a concomitant rise of inflammatory acute phase proteins, which peaked in the serum 1 month after the switch. Analyzing the impact of sirolimus introduction on cytokine microenvironment, we observed an increase of IL6 and TNFα without compensation of the negative feedback loops dependent on IL10 and soluble TNF receptors. IL6 and TNFα changes correlated with the intensity of biochemical and clinical inflammatory manifestations in a linear regression model. CONCLUSIONS: Sirolimus triggers a destabilization of the inflammatory cytokine balance in transplanted patients that promotes a paradoxical inflammatory response with mild stochastic clinical symptoms in the weeks following drug introduction. This pathophysiologic mechanism unifies the various individual inflammatory side effects recurrently reported with sirolimus suggesting that they should be considered as a single syndromic entity.

  14. Benefits of a clinical data warehouse with data mining tools to collect data for a radiotherapy trial.

    Science.gov (United States)

    Roelofs, Erik; Persoon, Lucas; Nijsten, Sebastiaan; Wiessler, Wolfgang; Dekker, André; Lambin, Philippe

    2013-07-01

    Collecting trial data in a medical environment is at present mostly performed manually and therefore time-consuming, prone to errors and often incomplete with the complex data considered. Faster and more accurate methods are needed to improve the data quality and to shorten data collection times where information is often scattered over multiple data sources. The purpose of this study is to investigate the possible benefit of modern data warehouse technology in the radiation oncology field. In this study, a Computer Aided Theragnostics (CAT) data warehouse combined with automated tools for feature extraction was benchmarked against the regular manual data-collection processes. Two sets of clinical parameters were compiled for non-small cell lung cancer (NSCLC) and rectal cancer, using 27 patients per disease. Data collection times and inconsistencies were compared between the manual and the automated extraction method. The average time per case to collect the NSCLC data manually was 10.4 ± 2.1 min and 4.3 ± 1.1 min when using the automated method (pdata collected for NSCLC and 5.3% for rectal cancer, there was a discrepancy between the manual and automated method. Aggregating multiple data sources in a data warehouse combined with tools for extraction of relevant parameters is beneficial for data collection times and offers the ability to improve data quality. The initial investments in digitizing the data are expected to be compensated due to the flexibility of the data analysis. Furthermore, successive investigations can easily select trial candidates and extract new parameters from the existing databases. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  15. Collective Labour Conflicts in Companies and Public Institutions: Some Prospects

    Directory of Open Access Journals (Sweden)

    Raluca DIMITRIU

    2011-10-01

    Full Text Available Participation of the employees and of the public servants in collective labor conflicts constitutes a significant chapter regarding the concrete way in which the Romanian legislator implements the concept of flexicurity and re-defines labor relations. Indeed, the entire Romanian legislation on labor relations and dispute resolution has been tremendously changed in May 2011, and the impact of these changes is about to be very intense. The new law on collective labor conflicts, currently at crossroads, is rather susceptible to discourage the initiation of such conflicts and even to limit the freedom of strike. The legislator adopted a unified regulation, applicable to both employees and public servants; as such individuals who work under an employment contract are governed by the same dispute resolution norms as those individuals who perform their professional activity under an administrative act. Beyond the theoretical aspects that the new view of the Romanian laws on the labor conflict resolution raises, there are many direct, practical consequences, as well as difficulties that courts face since the entering into force of the new legislation. This study aims to analyze some of these practical consequences.

  16. The impact of clinical pharmacist and ID intervention in rationalization of antimicrobial use.

    Science.gov (United States)

    Al-Somai, Niaz; Al-Muhur, Mohammed; Quteimat, Osama; Hamzah, Nashaat

    2014-12-01

    There is little research on the impact of implementing and monitoring antimicrobial policy in Saudi hospitals. The purpose of this study is to measure the impact of the clinical pharmacist (CP) and infectious disease consultant (ID) interventions on the use of three antimicrobials (caspofungin, imipenem, meropenem) in hospitalized patients in the King Abdullah Medical City hospital. The study was carried out in the King Abdullah Medical City, in Mekkah, Saudi Arabia. The hospital is a tertiary center that provides CCU, CSICU, Cardiac, Hematology, ICU, Medical, Neuroscience, Oncology, and specialized surgery services. The use of three antimicrobials (caspofungin, imipenem, meropenem) was reviewed by the clinical pharmacist for four periods, pre and post implementation of policy. Relevant data were collected in four periods. In the first period, before policy implementation, data were collected retrospectively to be used as baseline status reference, and in the three remaining periods that followed data were collected prospectively, and compared to baseline data, to evaluate the role of clinical pharmacist and ID interventions in optimizing antimicrobial therapy. Caspofungin duration of therapy was not affected significantly by the intervention. Statistically significant reduction in antimicrobial therapy duration was observed in imipenem (37%) and meropenem (37%) from baseline, which indicate a better control on antimicrobial use and reduction in antimicrobial resistance. The impact of the clinical pharmacist and ID interventions, in reducing antimicrobial therapy duration using imipenem and meropenem, is clear from the result presented above. However, lack of restriction and follow up in the antimicrobial policy in case of negative culture makes antimicrobial use uncontrollable in these cases. Establishing good and accepted policy may help reduce consumption and total cost of therapy.

  17. Drug-drug interactions in patients treated for cancer : a prospective study on clinical interventions

    NARCIS (Netherlands)

    van Leeuwen, R. W. F.; Jansman, F. G. A.; van den Bemt, P. M. L. A.; de Man, F.; Piran, F.; Vincenten, I.; Jager, A.; Rijneveld, A. W.; Brugma, J. D.; Mathijssen, R. H. J.; van Gelder, T.

    Background: Drug-drug interactions (DDIs) are of major concern in oncology, since cancer patients typically take many concomitant medications. Retrospective studies have been conducted to determine the prevalence of DDIs. However, prospective studies on DDIs needing interventions in cancer patients

  18. Clinical prospective study with radioiodinated monoclonal antibodies directed against colorectal cancer

    International Nuclear Information System (INIS)

    Chatal, J.F.; Douillard, J.Y.; Kremer, M.; Curtet, C.; Le Mevel, B.; Saccavini, J.C.; Maurel, C.; Aubry, J.

    1985-01-01

    The diagnostic application of three monoclonal antibodies are studied: an anti-carcinoembryonic antigen (CEA) antibody designated as 202 and two monoclonal antibodies, designated as 17-1A and 19-9, which recognize different antigens associated with gastrointestinal carcinomas. The complementary specificity of these antibodies was determined by an immuno-histochemical study and the scintigraphic detection parameters by a radiopharmacokinetic study in colic-tumour-bearing nude mice. On the basis of a prospective study, the value of immunoscintigraphy was compared with conventional methods such as ultrasonography and computed tomography for localization of recurrences of colorectal cancers. (UK)

  19. Coronary artery disease in patients with cerebrovascular disease: a prospective study

    International Nuclear Information System (INIS)

    Rokey, R.; Rolak, L.A.; Harati, Y.; Kutka, N.; Verani, M.S.

    1984-01-01

    Coronary artery disease is the cause of death in most patients who have transient ischemic attacks or stroke. Evaluation for this condition is not routinely performed in such patients, and no prospective studies have been reported. We prospectively examined 50 consecutive patients with transient ischemic attacks or mild stroke to determine the prevalence and importance of coronary artery disease. All patients were examined by a cardiologist and underwent both exercise thallium-201 scintigraphy and exercise radionuclide ventriculography. Sixteen patients were suspected to have coronary artery disease on the basis of clinical evaluation. In 15 of these the was confirmed by the nuclear scans. The remaining 34 patients had no clinical evidence of heart disease, yet 14 had abnormal cardiac scans. Twenty of 22 patients with abnormal scans who underwent cardiac catheterization had significant coronary artery disease or a cardiomyopathy. The discovery of heart disease altered clinical management in 13 patients. Overall, 29 of 50 patients had significant coronary artery disease, compared with a 7% prevalence of the condition in other patients of similar age at the same institution

  20. Coffee consumption during pregnancy and the risk of hyperkinetic disorder and ADHD: a prospective cohort study

    DEFF Research Database (Denmark)

    Linnet, Karen Markussen; Wisborg, Kirsten; Secher, Niels Jørgen

    2008-01-01

    Aim: Based on hypotheses from experimental studies, we studied the association between intrauterine exposure to coffee and the risk of clinically verified hyperkinetic disorder and attention-deficit hyperactivity disorder (ADHD). Methods: A cohort study with prospectively collected data from...... 88 children with hyperkinetic disorder and ADHD. Information about coffee consumption during pregnancy was obtained at 16 weeks of gestation from self-administrated questionnaires. Potential confounding factors were evaluated using Cox regression analyses. Results: We found that intrauterine exposure...... to 10 or more cups of coffee per day was associated with a threefold increased risk of hyperkinetic disorder and ADHD. After adjustments for a number of confounding factors, the risk decreased and became statistically insignificant (RR 2.3, 95% CI 0.9-5.9). Conclusion: Prenatal exposure to high levels...

  1. Survival rates of IPS empress 2 all-ceramic crowns and fixed partial dentures: results of a 5-year prospective clinical study.

    Science.gov (United States)

    Marquardt, Pascal; Strub, Jörg Rudolf

    2006-04-01

    The aim of this prospective clinical study was to evaluate the survival rates of IPS Empress 2 (Ivoclar Vivadent) all-ceramic crowns and fixed partial dentures (FPDs) after an observation period of up to 5 years. Forty-three patients (19 women and 24 men) were included in this study. The patients were treated with a total of 58 adhesive bonded IPS Empress 2 restorations. A total of 27 single crowns were placed on molars and premolars, and 31 three-unit FPDs were placed in the anterior and premolar regions. Clinical follow-up examinations took place at 6, 12, 24, 36, 48, and 60 months after insertion. Statistical analysis of the data was calculated using the Kaplan-Meier method. Results of the 50-month analysis (interquartile range, 33 to 61 months) showed that the survival rate was 100% for crowns and 70% for FPDs. Six failures that occurred exclusively in the three-unit FPDs were observed. Framework fractures were recorded in three FPD units where the connector dimensions did not meet the manufacturer specifications. Only one FPD exhibited an irreparable partial veneer fracture, and 2 FPDs showed evidence of biologic failures. The accuracy of fit and esthetic parameters were clinically satisfactory for crowns and FPDs. The results of this 5-year clinical evaluation suggest that IPS Empress 2 ceramic is an appropriate material for the fabrication of single crowns. Because of the reduced survival rates, strict conditions should be considered before the use of IPS Empress 2 material for the fabrication of three-unit FPDs.

  2. Characterization of genome sequences and clinical features of coxsackievirus A6 strains collected in Hyogo, Japan in 1999-2013.

    Science.gov (United States)

    Ogi, Miki; Yano, Yoshihiko; Chikahira, Masatsugu; Takai, Denshi; Oshibe, Tomohiro; Arashiro, Takeshi; Hanaoka, Nozomu; Fujimoto, Tsuguto; Hayashi, Yoshitake

    2017-08-01

    Coxsackievirus A6 (CV-A6) is an enterovirus, which is known to cause herpangina. However, since 2009 it has frequently been isolated from children with hand, foot, and mouth disease (HFMD). In Japan, CV-A6 has been linked to HFMD outbreaks in 2011 and 2013. In this study, the full-length genome sequencing of CV-A6 strains were analyzed to identify the association with clinical manifestations. Five thousand six hundred and twelve children with suspected enterovirus infection (0-17 years old) between 1999 and 2013 in Hyogo Prefecture, Japan, were enrolled. Enterovirus infection was confirmed with reverse transcriptase-PCR in 753 children (791 samples), 127 of whom (133 samples) were positive for CV-A6 based on the direct sequencing of the VP4 region. The complete genomes of CV-A6 from 22 positive patients with different clinical manifestations were investigated. A phylogenetic analysis divided these 22 strains into two clusters based on the VP1 region; cluster I contained strains collected in 1999-2009 and mostly related to herpangina, and cluster II contained strains collected in 2011-2013 and related to HFMD outbreak. Based on the full-length polyprotein analysis, the amino acid differences between the strains in cluster I and II were 97.7 ± 0.28%. Amino acid differences were detected in 17 positions within the polyprotein. Strains collected in 1999-2009 and those in 2011-2013 were separately clustered by phylogenetic analysis based on 5'UTR and 3Dpol region, as well as VP1 region. In conclusion, HFMD outbreaks by CV-A6 were recently frequent in Japan and the accumulation of genomic change might be associated with the clinical course. © 2017 Wiley Periodicals, Inc.

  3. Evaluating the Effect of Ramadan Fasting on Muslim Patients with Diabetes in relation to Use of Medication and Lifestyle Patterns: A Prospective Study.

    Science.gov (United States)

    Siaw, Melanie Yee Lee; Chew, Daniel Ek Kwang; Dalan, Rinkoo; Abdul Shakoor, Shaikh Abdul Kader Kamaldeen; Othman, Noorani; Choo, Chor Hui; Shamsuri, Nur Hidayah; Abdul Karim, Siti Nurhana; Chan, Sui Yung; Lee, Joyce Yu-Chia

    2014-01-01

    Objectives. This study aimed to examine the effect of Ramadan fasting on HbA1c in Muslim patients with type 2 diabetes. The incidence of hypoglycemia and glycemic changes in relation to the adjustment of doses of antidiabetic agents, diet, and physical activity during Ramadan was also evaluated. Methods. This was a prospective study conducted in an outpatient endocrine clinic. A set of questionnaires was administered to Muslim patients with diabetes who fasted for ≥10 days. Those who were hospitalized for diabetic ketoacidosis or severe hypoglycemia a month prior to Ramadan or were given short-term corticosteroid therapy were excluded. The patients' resp