WorldWideScience

Sample records for open prospective pilot

  1. Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial

    Directory of Open Access Journals (Sweden)

    Simsarian JP

    2011-07-01

    Full Text Available James P Simsarian, Carol Saunders, D Michelle SmithNeurology Center of Fairfax Ltd, Fairfax, VA, USABackground: Despite over 50 years of experience with adrenocorticotropic hormone (ACTH as a treatment for acute exacerbations of multiple sclerosis, there have been no trials examining the options of the 2–3-week dosing regimen or intramuscular injection protocol used in the original trials. At our clinic, we performed a small, prospective, randomized pilot study to examine the efficacy and safety of, and patient satisfaction with, a short (five-day self-administered ACTH dosing protocol for exacerbations of multiple sclerosis, and to compare the subcutaneous and intramuscular routes of administration.Methods: Patients for this study were recruited from an outpatient treatment clinic. Each patient self-administered natural ACTH gel 80 U/day by subcutaneous or intramuscular injection for five consecutive days and was evaluated at baseline and on days 7 and 14. Patient feedback was collected using the Patient Global Impression of Change (PGI-C, the primary efficacy measure, a patient global visual analog scale, the Expanded Disability Status Scale, a timed walk, the Nine-hole Peg Test, and the Clinical Global Impression of Change.Results: Of the 20 enrolled patients (mean age 39.5 years, 19 completed the study. On day 14, 61.1% of patients (11 of 18 with day 14 scores were treatment responders, and rated their condition as "very much improved" or "much improved" on the PGI-C. The intramuscular group had numerically more responders, but there was no significant difference in the proportion of responders between the intramuscular and subcutaneous groups at day 14 (P = 0.3. The intramuscular route of injection was associated with more injection site pain than the subcutaneous route.Conclusion: A shorter five-day course of intramuscular or subcutaneous ACTH gel may improve symptoms associated with acute exacerbations of multiple sclerosis. Larger

  2. Efficacy and safety of Everolimus in children with TSC - associated epilepsy - Pilot data from an open single-center prospective study.

    Science.gov (United States)

    Samueli, Sharon; Abraham, Klaus; Dressler, Anastasia; Gröppel, Gudrun; Mühlebner-Fahrngruber, Angelika; Scholl, Theresa; Kasprian, Gregor; Laccone, Franco; Feucht, Martha

    2016-11-03

    Epilepsy occurs in up to 90 % of all individuals with tuberous sclerosis complex (TSC). In 67 % disease onset is during childhood. In ≥ 50 % seizures are refractory to currently available treatment options. The mTOR-Inhibitor Everolimus (Votubia®) was approved for the treatment of subependymal giant cell astrocytoma (SEGA) and renal angiomyolipoma (AML) in Europe in 2011. It's anticonvulsive/antiepileptic properties are promising, but evidence is still limited. Study aim was to evaluate the efficacy and safety of Everolimus in children and adolescents with TSC-associated epilepsies. Inclusion-criteria of this investigator-initiated, single-center, open, prospective study were: 1) the ascertained diagnosis of TSC; 2) age ≤ 18 years; 3) treatment indication for Votubia® according to the European Commission guidelines; 4) drug-resistant TSC-associated epilepsy, 5) prospective continuous follow-up for at least 6 months after treatment initiation and 6) informed consent to participate. Votubia® was orally administered once/day, starting with 4.5 mg/m(2) and titrated to achieve blood trough concentrations between 5 and 15 ng/ml. Primary endpoint was the reduction in seizure frequency of ≥ 50 % compared to baseline. Fifteen patients (nine male) with a median age of six (range; 1-18) years fulfilled the inclusion criteria. 26 % (4/15) had TSC1, 66 % (10/15) had TSC2 mutations. In one patient no mutation was found. Time of observation after treatment initiation was median 22 (range; 6-50) months. At last observation, 80 % (12/15) of the patients were responders, 58 % of them (7/12) were seizure free. The overall reduction in seizure frequency was 60 % in focal seizures, 80 % in generalized tonic clonic seizures and 87 % in drop attacks. The effect of Everolimus was seen already at low doses, early after treatment initiation. Loss of efficacy over time was not observed. Transient side effects were seen in 93 % (14/15) of the patients. In no case the

  3. Efficacy of topical hydrating and emollient lotion containing 10% urea ISDIN® plus dexpanthenol (Ureadin Rx 10) in the treatment of skin xerosis and pruritus in hemodialyzed patients: an open prospective pilot trial.

    Science.gov (United States)

    Castello, M; Milani, M

    2011-10-01

    Dry skin and pruritus are common complication of end-stage renal diseases (ESRD), affecting up to 80% of dialysis patients. They are chronic, unpleasant skin manifestations with a strong negative impact on patients' quality of life, often inducing sleeplessness and mood disorders. The pathogenesis of skin xerosis (SX) and uraemic pruritus (UP) are multifactorial. Moisturizing emollients are commonly used for the treatment of SX and UP. Urea is used in dermatology due to its excellent hydrating and moisturizing properties. Urea is useful in all cases of dry skin and, depending on the concentration levels, will act as moisturizing or keratolitic agent. Ureadin Rx 10 is a topical hydrating and emollient lotion formulation. So far no data are available regarding the efficacy of topical application of urea in lotion in the treatment of SX and UP in dialysed patients. In a prospective open pilot trial we assessed the effect of topical 10% Urea ISDIN® plus dexpanthenol lotion in the treatment of SX and UP in dialyzed patients. A total of 15 hemodialyzed patients (3 men; 12 women, mean age 66 years) with SX and UP were enrolled after their informed consent in the trial. Topical 10% Urea ISDIN® plus dexpanthenol (Ureadin RX; ISDIN) lotion (URx) was applied twice daily over the arm and the legs for 28 consecutive days. Primary outcomes were a 5-point SRRC Index score (evaluating scaling roughness, redness and cracks) and a 4-point itching score (IS) both measured at baseline and after 2 and 4 weeks of treatment. At baseline mean (SD) SRRC was 5 (2.3). After URx treatment SRRC significantly (P=0.0001) decreased to 1.6 (2.1) and to 0.9 (1.2) after two and four weeks respectively (a relative reduction of 82% at week 4). IS at baseline was 1.0 (1.4). URx reduced IS significantly (P=0.008) to 0.2 (0.5) at week 2 and to 0.06 at week 4 (a relative reduction of 94% at week 4). Local tolerability was excellent/good in 14 out of 15 patients. One patient reported mild burning

  4. Pilot job accounting and auditing in Open Science Grid

    Energy Technology Data Exchange (ETDEWEB)

    Sfiligoi, Igor; Green, Chris; /Fermilab; Quinn, Greg; Thain, Greg; /Wisconsin U., Madison

    2008-06-01

    The Grid accounting and auditing mechanisms were designed under the assumption that users would submit their jobs directly to the Grid gatekeepers. However, many groups are starting to use pilot-based systems, where users submit jobs to a centralized queue and are successively transferred to the Grid resources by the pilot infrastructure. While this approach greatly improves the user experience, it does disrupt the established accounting and auditing procedures. Open Science Grid deploys gLExec on the worker nodes to keep the pilot-related accounting and auditing information and centralizes the accounting collection with GRATIA.

  5. Wood torrefaction. Pilot tests and utilisation prospects

    Energy Technology Data Exchange (ETDEWEB)

    Wilen, C.; Jukola, P.; Jarvinen, T.; Sipila, K. [VTT Technical Reseach Centre of Finland, Espoo (Finland); Verhoeff, F.; Kiel, J. [Energy research Centre of the Netherlands, LE Petten (Netherlands)

    2013-09-15

    The research project 'Torrefaction of woody biomasses as energy carriers for the European markets' was carried out within the Tekes BioRefine programme in 2010-2012 and was coordinated by VTT. The main objective of the project was to create a discussion platform and collate basic information for the Finnish industrial stakeholders involved in developing torrefaction technology or planning to include torrefied biomass in their fuel supply for energy production. Given the availability of torrefaction pilot facilities in Europe, it was decided at an early phase of the national torrefaction research project not to build and operate separate pilot equipment, and thus save time and money. Experimental research was conducted in cooperation with ECN, The Netherlands. Finnish wood chips and crushed forest residue were tested at different torrefaction temperatures in the PATRIG torrefaction test rig with great success, and large quantities of torrefied wood chips and pellets were produced. CFD simulation work was carried out at VTT to investigate the feasibility of torrefied fuels to replace part of the coal. From the combustion point of view it seems feasible to replace coal by torrefied wood biomass with shares up to 50% by weight. Basic, small-scale experiments were carried out to compare torrefied wood pellets with conventional wood and straw pellets with regard to their handling and storage properties. The experiments showed that the torrefied pellets are clearly more hydrophobic than wood and straw pellets and do not disintegrate completely on exposure to water. A study on dust explosion and self-ignition characteristics indicated that the torrefied dust does not differ significantly from the normal biomass dust, but is clearly more reactive than coal dust. Commercial development of torrefaction is currently in its early phase. The current general view is that most of the demonstration plants have technical problems, which have delayed their commercial

  6. Peer-Reviewed Open Research Data: Results of a Pilot

    Directory of Open Access Journals (Sweden)

    Marjan Grootveld

    2012-12-01

    Full Text Available Peer review of publications is at the core of science and primarily seen as instrument for ensuring research quality. However, it is less common to independently value the quality of the underlying data as well. In the light of the ‘data deluge’ it makes sense to extend peer review to the data itself and this way evaluate the degree to which the data are fit for re-use. This paper describes a pilot study at EASY - the electronic archive for (open research data at our institution. In EASY, researchers can archive their data and add metadata themselves. Devoted to open access and data sharing, at the archive we are interested in further enriching these metadata with peer reviews.As a pilot, we established a workflow where researchers who have downloaded data sets from the archive were asked to review the downloaded data set. This paper describes the details of the pilot including the findings, both quantitative and qualitative. Finally, we discuss issues that need to be solved when such a pilot is turned into a structural peer review functionality for the archiving system.

  7. Prospecting for chemical tags among open clusters

    CERN Document Server

    Lambert, David L

    2016-01-01

    Determinations of the chemical composition of red giants in a large sample of open clusters show that the abundances of the heavy elements La, Ce, Nd and Sm but not so obviously Y and Eu vary from one cluster to another across a sample all having about the solar metallicity. For La, Ce, Nd and Sm the amplitudes of the variations at solar metallicity scale approximately with the main s-process contribution to solar system material. Consideration of published abundances of field stars suggest that such a spread in heavy element abundances is present for the thin and thick disk stars of different metallicity. This new result provides an opportunity to chemically tag stars by their heavy elements and to reconstruct dissolved open clusters from the field star population.

  8. 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.

  9. Problems and Prospects of Open and Distance Education in Nigeria

    Directory of Open Access Journals (Sweden)

    Mudasiru Olalere YUSUF

    2006-01-01

    Full Text Available Problems and Prospects of Open and Distance Education in Nigeria Mudasiru Olalere YUSUF (Ph.D Senior lecturer (Educational Technology Department of Curriculum Studies and Educational Technology, Faculty of Education University of Ilorin, Ilorin NIGERIA ABSTRACT Distance education as a mean of providing access to education, particularly tertiary level education, has gained great prominence in the world. Nigeria has taken giant steps of recent to introduce open and distance education programme. This paper explores the major terms inherent in open and distance education, its potentials, possible factors that may inhibit successful implementation of the programme, and the use of low and high technological tools for its implementation. The paper recommended the use of Organisation Element Model (OEM as suggested by (Kaufman, Watkins & Guerra, 2001 for its planning and implementation, and also stressed the need for improvement in electricity and communication services.

  10. Acoustic conditions in open plan offices – Pilot test results

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    Witold Mikulski

    2016-10-01

    Full Text Available Background: The main source of noise in open plan office are conversations. Office work standards in such premises are attained by applying specific acoustic adaptation. This article presents the results of pilot tests and acoustic evaluation of open space rooms. Material and Methods: Acoustic properties of 6 open plan office rooms were the subject of the tests. Evaluation parameters, measurement methods and criterial values were adopted according to the following standards: PN-EN ISO 3382- 3:2012, PN-EN ISO 3382-2:2010, PN-B-02151-4:2015-06 and PN-B-02151-3:2015-10. Results: The reverberation time was 0.33– 0.55 s (maximum permissible value in offices – 0.6 s; the criterion was met, sound absorption coefficient in relation to 1 m2 of the room’s plan was 0.77–1.58 m2 (minimum permissible value – 1.1 m2; 2 out of 6 rooms met the criterion, distraction distance was 8.5–14 m (maximum permissible value – 5 m; none of the rooms met the criterion, A-weighted sound pressure level of speech at a distance of 4 m was 43.8–54.7 dB (maximum permissible value – 48 dB; 2 out of 6 rooms met the criterion, spatial decay rate of the speech was 1.8–6.3 dB (minimum permissible value – 7 dB; none of the rooms met the criterion. Conclusions: Standard acoustic treatment, containing sound absorbing suspended ceiling, sound absorbing materials on the walls, carpet flooring and sound absorbing workplace barriers, is not sufficient. These rooms require specific advanced acoustic solutions. Med Pr 2016;67(5:653–662

  11. Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

    Science.gov (United States)

    Royston, Natalie Steele; Springer, D. Gregory

    2015-01-01

    The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

  12. Beliefs of Applied Studio Faculty on Desirable Traits of Prospective Music Education Majors: A Pilot Study

    Science.gov (United States)

    Royston, Natalie Steele; Springer, D. Gregory

    2015-01-01

    The purpose of this pilot study was to examine the beliefs of applied music faculty on desirable traits of prospective music education majors. Researcher-designed surveys were sent electronically to applied music faculty at 12 National Association of Schools of Music-accredited institutions randomly selected from each of the four major divisions…

  13. EFFECTIVENESS OF OPEN DISCECTOMY FOR IVDP – A PROSPECTIVE STUDY

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    Ranganath

    2014-02-01

    Full Text Available BACKGROUND AND OBJECTIVES: Low back pain (LBP results in loss in productivity than any other medical condition. Approximately 70 - 80% of all people will develop LBP in their life . There are various causes of LBP , out of which the lumber disc herniation is one of the most frequent reason for physical , functional restriction in patients. Patients who have u ndergone surgical treatment are found to possess increased short term outcome instead of conservative treated patients. Surgically treated patients experienced fast pain relief , improvement of function & satisfaction in comparison to conservative patients. The comparative results of patients treated with surgery and conservatively treated patients have revealed that surgical treatment is much better at short term follow up (upto 1 year however no variations have been shown among treatment at long term foll ow up. Some patients operated for spine diseases are still left with poor results. The present study aims to evaluate the efficiency of open discectomy for L 4 – L 5 IVDP prospectively. METHODS : 30 cases of lumbar disc prolapse , above 18 years of age admitte d at KIMS hospital , Bangalore with MRI showing conclusive disc prolapsed were taken for the study. They were pre operatively evaluated for their ODI score. Only those patients who have scored 40% and above in ODI were included in the study. They underwent dis c ectomy. Methods of surgery used were fenestration , extended fenestration , hemilaminectomy & total laminectomy as per operative requirement. Follow - ups were carried out at 6 , 12 and 24weeks on selected areas. Pre and post of ODI total and sub scale scor es were compared at the end of 24 weeks. RESULTS : There was a significant reduction of post operative ODI score indicating good success rate in open disectomy. The pre operative mean ODI score was 58.28 , SD was 5.06 and the post operative mean ODI score wa s 15.28 and SD was 2.40 with t value of 38.56 and p value of

  14. Mouth opening in patients irradiated for head and neck cancer : A prospective repeated measures study

    NARCIS (Netherlands)

    Kamstra, J. I.; Dijkstra, P. U.; van Leeuwen, M.; Roodenburg, J. L. N.; Langendijk, J. A.

    2015-01-01

    Objectives: Aims of this prospective cohort study were (1) to analyze the course of mouth opening up to 48 months post-radiotherapy (RT), (2) to assess risk factors predicting decrease in mouth opening, and (3) to develop a multivariable prediction model for change in mouth opening in a large sample

  15. Mouth opening in patients irradiated for head and neck cancer : A prospective repeated measures study

    NARCIS (Netherlands)

    Kamstra, J. I.; Dijkstra, P. U.; van Leeuwen, M.; Roodenburg, J. L. N.; Langendijk, J. A.

    Objectives: Aims of this prospective cohort study were (1) to analyze the course of mouth opening up to 48 months post-radiotherapy (RT), (2) to assess risk factors predicting decrease in mouth opening, and (3) to develop a multivariable prediction model for change in mouth opening in a large sample

  16. Prospects for the ensemble asteroseismology in young open clusters

    CERN Document Server

    Moździerski, Dawid

    2016-01-01

    This is a progress report on the ongoing project dealing with ensemble asteroseismology of B-type stars in young open clusters. The project is aimed at searches for B-type pulsating stars in open clusters, determination of atmospheric parameters for some members and seismic modeling of B-type pulsators. Some results for NGC 457, IC 1805, IC 4996, NGC 6910 and alpha Per open clusters are presented. For the last cluster, BRITE data for five members were used.

  17. Prospect for Development of Open Access in Argentina

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    Miguel, Sandra; Bongiovani, Paola C.; Gomez, Nancy D.; Bueno-de-la-Fuente, Gema

    2013-01-01

    This perspective article presents an overview of the Open Access movement in Argentina, from a global and regional (Latin American) context. The article describes the evolution and current state of initiatives by examining two principal approaches to Open Access in Argentina: "golden" and "green roads". The article will then…

  18. Prospect for Development of Open Access in Argentina

    Science.gov (United States)

    Miguel, Sandra; Bongiovani, Paola C.; Gomez, Nancy D.; Bueno-de-la-Fuente, Gema

    2013-01-01

    This perspective article presents an overview of the Open Access movement in Argentina, from a global and regional (Latin American) context. The article describes the evolution and current state of initiatives by examining two principal approaches to Open Access in Argentina: "golden" and "green roads". The article will then…

  19. Prospective assessment of stereoscopic visual status and USAF pilot training attrition.

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    Snyder, Q C; Lezotte, D C

    1993-01-01

    The role of stereopsis (i.e., the use of binocular cues for depth perception) in military aviation is undetermined. Pilots possessing adequate near stereopsis but having deficient distant stereopsis are thought to have microtropias. Historical reviews of microtropia and research concerning the role of depth perception in military aviation are described. A historical prospective study of student pilots entering U.S. Air Force Undergraduate Pilot Training (UPT) from Oct 1990 through Sep 1991 (FY 90-91) compares UPT attrition rates according to their preselection stereoscopic status (microtropia vs. normal). Univariate and multiple logistic regression analyses do not show significant differences in attrition rates between the two groups, implying that distant stereopsis is not critical to successful completion of UPT. The U.S. Air Force decided in Oct 91 to eliminate near stereoscopic vision screening while retaining distant stereoacuity testing as a criterion for candidates to qualify medically for UPT. Valid rationale for this decision includes simplified and uniform administration of stereoacuity testing, minimizing spurious results, the continued validity of stereopsis testing as a cross-check of other areas of visual function, the uncertain role of stereopsis in critical areas of flight operations, and the large applicant pool competing for a limited number of pilot training positions.

  20. Tocotrienol Treatment in Familial Dysautonomia: Open-Label Pilot Study.

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    Cheishvili, David; Maayan, Channa; Holzer, Naama; Tsenter, Jeanna; Lax, Elad; Petropoulos, Sophie; Razin, Aharon

    2016-07-01

    Familial dysautonomia (FD) is an autosomal recessive congenital neuropathy, primarily presented in Ashkenazi Jews. The most common mutation in FD patients results from a single base pair substitution of an intronic splice site in the IKBKAP gene which disrupts normal mRNA splicing and leads to tissue-specific reduction of IKBKAP protein (IKAP). To date, treatment of FD patients remains preventative, symptomatic and supportive. Based on previous in vitro evidence that tocotrienols, members of the vitamin E family, upregulate transcription of the IKBKAP gene, we aimed to investigate whether a similar effects was observed in vivo. In the current study, we assessed the effects of tocotrienol treatment on FD patients' symptoms and IKBKAP expression in white blood cells. The initial daily doses of 50 or 100 mg tocotrienol, doubled after 3 months, was administered to 32 FD patients. Twenty-eight FD patients completed the 6-month study. The first 3 months of tocotrienol treatment was associated with a significant increase in IKBKAP expression level in FD patients' blood. Despite doubling the dose after the initial 3 months of treatment, IKBKAP expression level returned to baseline by the end of the 6-month treatment. Clinical improvement was noted in the reported clinical questionnaire (with regard to dizziness, bloching, sweating, number of pneumonia, cough episodes, and walking stability), however, no significant effect was observed in any clinical measurements (weight, height, oxygen saturation, blood pressure, tear production, histamine test, vibration threshold test, nerve conduction, and heart rate variability) following Tocotrienol treatment. In conclusion, tocotrienol treatment appears significantly beneficial by clinical evaluation for some FD patients in a few clinical parameters; however it was not significant by clinical measurements. This open-label study shows the complexity of effect of tocotrienol treatment on FD patients' clinical outcomes and on

  1. The Openness of the University of the Philippines Open University: Issues and Prospects

    Directory of Open Access Journals (Sweden)

    Maria Fe Villamejor-Mendoza

    2013-05-01

    Full Text Available This paper is a self-reflection on the state of openness of the University of the Philippines Open University (UPOU. An exploratory and descriptive study, it aims not only to define the elements of openness of UPOU, but also to unravel the causes and solutions to the issues and concerns that limit its options to becoming a truly open university. It is based on four parameters of openness, which are widely universal in the literature, e.g., open admissions, open curricula, distance education at scale, and the co-creation, sharing and use of open educational resources (OER. It draws from the perception survey among peers, which the author conducted in UPOU in July and August 2012. It also relies on relevant secondary materials on the subject.

  2. Ukraine Open University: Its prospects in distance education development

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    Bohdan Shunevych

    2002-01-01

    Full Text Available The genesis, initiation, and expansion of distance education at the Ukraine Open International University for Human Development, located in Kyiv, will be examined in this case study, starting with a brief look at the positive changes taking place in Ukraine's traditional educational system, as well as recent developments in the country's distance education (DE system. To help readers understand the University's development from an insider's perspective, societal factors that currently influence its inter- and extra-institutional environment will also be examined. Next, the history, organizational structure, institutional activities, and background of the Ukraine Open International University for Human Development, along with the reasons driving the University's dual mode activities - both traditional and distance education - will be briefly analyzed. Included in this analysis is a summary of the challenges surrounding the application of both traditional and distance education models.The author concludes his case study by reflecting upon Ukraine Open International University for Human Development's experiences within the context of its being both a traditional education provider and new dual-mode distance education provider. Also discussed are some key indicators and predictions about what the future may hold for the University.

  3. Laparoscopic and open incisional hernia repair: A prospective randomized study

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    Mehmet Zafer Sabuncuoğlu

    2015-07-01

    Full Text Available As the number of major surgical procedures has increased in recent years, so there has been an increase in incisional hernias. With gained experience and new materials, laparoscopic repair of incisional hernia is now applied. This study was aimed to compare the results of incisional hernia repair with the open surgery or laparoscopic approach at the only centre in the region for laparoscopic incisional hernia repair. A total of 55 cases of incisional hernia at the General Surgery Clinic of SDU between November 2012 and 2014 were underwent laparoscopic ventral hernia repair (L-VHR and conventional incisional hernia repair (C-VHR. From the L-VHR group 6 cases and from the C-VHR 9 cases were excluded from the study, as they did not meet the inclusion criteria or did not wish to participate in the study. The two techniques were compared in respect of operative time, length of hospital stay, postoperative pain scores, complications and recurrence. A total of 40 cases of incisional hernia repair were evaluated. The mean follow-up period was found as 12.75±4.19 months. No difference was determined between the characteristics of the patients due to age, body mass index, American Society of Anesthesiologists (ASA score, comorbidities, hernia size, and follow-up. In the laparoscopic repair group, the postoperative pain scores, complication rates and duration of hospital stay were found significantly superior to those of the open technique group. While there was no mortality seen and wound complications as a morbidity were 0 % in the L-VHR (n = 0 and 20 % in C-VHR group (n = 4. In the comparison of mean operative time, the duration of surgery was significantly shorter in the laparoscopic repair group (67.25±19.23 min compared to the open technique group (91.50±24.87 min (p=0.001. Laparoscopic repair was associated with less postoperative pain (4.35±1.03 vs 5.60±1.31, p=0.002, lesser postoperative complications (5% vs. 35%, p=0.044, and shorter

  4. An open access pilot freely sharing cancer genomic data from participants in Texas.

    Science.gov (United States)

    Becnel, Lauren B; Pereira, Stacey; Drummond, Jennifer A; Gingras, Marie-Claude; Covington, Kyle R; Kovar, Christie L; Doddapaneni, Harsha Vardhan; Hu, Jianhong; Muzny, Donna; McGuire, Amy L; Wheeler, David A; Gibbs, Richard A

    2016-02-16

    Genomic data sharing in cancer has been restricted to aggregate or controlled-access initiatives to protect the privacy of research participants. By limiting access to these data, it has been argued that the autonomy of individuals who decide to participate in data sharing efforts has been superseded and the utility of the data as research and educational tools reduced. In a pilot Open Access (OA) project from the CPRIT-funded Texas Cancer Research Biobank, many Texas cancer patients were willing to openly share genomic data from tumor and normal matched pair specimens. For the first time, genetic data from 7 human cancer cases with matched normal are freely available without requirement for data use agreements nor any major restriction except that end users cannot attempt to re-identify the participants (http://txcrb.org/open.html).

  5. MANAGEMENT OF COMPLEX OPEN FRACTURES: A PROSPECTIVE STUDY

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    Satyanarayana

    2015-10-01

    Full Text Available BACKGROUND : The incidence of Open fractures is on the rise, due to the increasing Road Traffic Accidents in India. In fact accidents are the leading cause of death in young, healthy individuals now. As the number of compound fractures are flooding the outpatient departments of all the major hospitals a viable and effective strategy has to be in place to manage these patients. The various treatment options available to treat these fractures and t heir effectiveness is the basis for this study. MATERIAL & METHODS : This study was conducted by our unit, from Department of Orthopedics and Traumat ology, Osmania General Hospital /Medical College during September 2012 to September 2014. The study comprises of 40 patients who were treated during this period, the patients selected were with Compound fractures Grade III A and Grade III B of Femur , Tibia and fibula. Various modalities of fixation were used in the management of these patients depending upon the clinical condition of the patient . CONCLUSIONS : External fixation was the mainstay of these fractures. It may be a first aid procedure or a definitive treatment option. The other options like Primary Nailing, biological plating have their own ind ications . Secondary procedures do play their role in the effective management of these complex injuries. All in all the successful management of these limb / life threatening injuries lies in the initial management and early intervention , secure fixation of fractures , prevention of infection and reasonable covering of the wounds.

  6. Intravenous fluids versus gastric-tube feeding in hospitalized infants with viral bronchiolitis: a randomized, prospective pilot study.

    Science.gov (United States)

    Kugelman, Amir; Raibin, Karine; Dabbah, Husein; Chistyakov, Irina; Srugo, Isaac; Even, Lea; Bzezinsky, Nurit; Riskin, Arieh

    2013-03-01

    The American Academy of Pediatrics recommends intravenous fluids for infants with bronchiolitis who are unable to sustain oral feedings. Our randomized, prospective pilot study shows that gastric tube feeding (in 31 infants) is feasible and demonstrated comparable clinical outcomes with intravenous fluids (in 20 infants) among hospitalized infants ≤6 months of age with moderate bronchiolitis.

  7. Treatment of open hand injuries: does timing of surgery matter? A single-centre prospective analysis.

    Science.gov (United States)

    Juon, Bettina H; Iseli, Michelle; Kreutziger, Janett; Constantinescu, Mihai A; Vögelin, Esther

    2014-10-01

    The 6-hour paradigm for surgical treatment of open injuries should be re-evaluated in the era of systematic use of antiseptic solutions and systemic antibiotics. The current study investigates prospectively the impact of timing of surgery on the outcome of open hand injuries. The prospective evaluation included adult patients presenting with open hand injuries between 1 September 2009 and 30 June 2010 to the emergency department of the University Hospital of Berne, Switzerland. Multiple trauma, bilateral hand injuries, bite injuries, and infections were excluded. All patients underwent a standardised treatment protocol with antiseptic solution, sterile dressing, antibiotic prophylaxis, and surgical treatment upon admission. Demographic data, injury details, and delay from trauma to therapy were recorded. Microbiology was gained at surgery. Outcome measurements included infections, complications, pain, and function (clinically, DASH, Mayo score). From 116 patients (mean age 43 years) six patients suffered an infection (5.2%). The observed infections were statistically not associated with delay to surgery, treatment protocol, or to injury complexity. Neither complications, pain, nor functional outcome were statistically associated with delay to surgery, wound disinfection, or administration of antibiotics. In conclusion, early or late timing of surgical treatment of open hand injuries did not show any impact on outcome (infections, complications, pain, function) in this prospective single-centre patient evaluation.

  8. Muscular workload of veterinary students during simulated open and laparoscopic surgery: A pilot study.

    Science.gov (United States)

    Kilkenny, Jessica; Larson, Dennis J; MacCormick, Mathew; Brown, Stephen H M; Singh, Ameet

    2017-08-01

    To compare upper extremity muscle activity and workload between simulated open surgery, multiple port laparoscopic surgery (MLS), and single incision laparoscopic surgery (SLS) techniques in veterinary students. Pilot study. Veterinary students (n = 10) from years 1 to 4. Bipolar skin surface electrodes were fixed bilaterally to the forearm flexor, forearm extensor, biceps brachii, triceps brachii, and upper trapezius muscles. Electromyography data were recorded during one repetition of 2 simulated surgical exercises via open surgery, MLS, and SLS. Participants completed a validated workload survey after each simulated surgical technique. Muscle activity and perceived workload were compared between surgical techniques with 1-way ANOVAs and Fisher's LSD post hoc tests. Muscle activity during peg transfer was higher with MLS and SLS compared to simulated open surgery in the right and left forearm extensors (both P < .0001), right (P < .0001) and left biceps (P = .0005), right triceps (P = .0004), and right upper trapezius muscles (P = .0211). Similar results were found for the right and left forearm extensors (both P < .0001), right (P = .0381) and left (P = .0147) forearm flexors, right biceps (P < .0001), and right triceps (P = .0004) during a simulated suture task. Participants found laparoscopic techniques more mentally demanding, physically demanding, complex, and stressful compared to a simulated open surgical technique. In veterinary students, average muscle activity and perceived workload were highest using MLS and SLS compared to an open surgical technique when performing simulated surgical exercises in a laparoscopic box trainer. © 2017 The American College of Veterinary Surgeons.

  9. Activation of Coagulation and Fibrinolysis in Acute Respiratory Distress Syndrome: a Prospective Pilot Study

    Directory of Open Access Journals (Sweden)

    Agnese Ozolina

    2016-11-01

    Full Text Available Introduction: Coagulation and fibrinolysis remain sparsely addressed with regards to acute respiratory distress syndrome (ARDS. We hypothesized that ARDS development might be associated with changes in plasma coagulation and fibrinolysis. Our aim was to investigate the relationships between ARDS diagnosis and plasma concentrations of tissue factor (TF, tissue plasminogen activator (t-PA and plasminogen activator inhibitor-1 (PAI-1 in mechanically ventilated patients at increased risk of developing ARDS. Materials and Methods: We performed an ethically approved prospective observational pilot study. Inclusion criteria: patients with PaO2/FiO2 < 300 mmHg admitted to the intensive care unit (ICU for mechanical ventilation for 24 hours, or more, because of one or more disease conditions associated with increased risk of developing ARDS. Exclusion criteria: age below 18 years; cardiac disease. We sampled plasma prospectively and compared patients who developed ARDS with those who did not using descriptive statistics and chi-square analysis of baseline demographical and clinical data. We also analyzed plasma concentrations of TF, t-PA and PAI-1 at inclusion (T0 and on third (T3 and seventh day (T7 of the ICU stay with non-parametric statistics inclusive their sensitivity and specificity associated with the development of ARDS using receiver operating characteristic (ROC curve analysis. Statistical significance: p < 0.05.Results: Of 24 patients at risk, six developed mild ARDS and four of each moderate or severe ARDS, respectively, 3 ± 2 (Mean ± SD days after inclusion. Median plasma concentrations of TF and PAI-1 were significantly higher at T7 in patients with ARDS, as compared to non-ARDS. Simultaneously, we found moderate correlations between plasma concentrations of TF and PAI-1, TF and PaO2/FiO2 and PEEP and TF. TF plasma concentration was associated with ARDS with 71% sensitivity and 100% specificity, a cut off level of 145 pg/ml and AUC 0

  10. Superstition predicts favorable weight change in an open-placebo trial: a prospective study.

    Science.gov (United States)

    Rekhviashvili, Nino; Gupta, Sumati

    2015-09-01

    Given the difficulty of losing weight via adhering to healthy lifestyle choices, this study sought to understand how a placebo may elicit favorable weight change. Specifically, we examined if superstition may be related to increased responsiveness to an open-placebo. In this pilot study of 25 undergraduate participants, it was hypothesized that individuals with higher levels of superstition may be more responsive to a 3-week open-placebo weight change trial. Participants were given once-daily saltine crackers to use as open-placebos for weight change in their preferred direction (gain or loss). The weight of each participant was measured before and after the 3-week open-placebo period. A Pearson's r correlation showed a significant positive relationship between superstition and placebo responsiveness, determined by weight gain or loss in the preferred direction, r (25) = 0.493, p < 0.05. We hope these preliminary results engender future research on open-placebo uses for weight management.

  11. A randomized, open-label pilot comparison of gabapentin and bupropion SR for smoking cessation.

    Science.gov (United States)

    White, William D; Crockford, David; Patten, Scott; El-Guebaly, Nady

    2005-10-01

    This 6-week, randomized, open-label pilot study estimated the treatment effect size of gabapentin (n = 17) compared with bupropion SR (n = 19) for smoking cessation, thereby allowing sample size calculations for a definitive comparison study. The primary outcome measure was smoking cessation. Secondary outcome measures included smoking reduction and withdrawal severity. Gabapentin was less efficacious than bupropion for smoking cessation but was associated with fewer dropouts from adverse effects. Withdrawal severity was less with bupropion. Bupropion remains the first-line non-nicotine pharmacotherapy for smoking cessation. Further study is required to determine if gabapentin has any useful role in smoking cessation. Based on our primary outcome measure, 79 subjects would be required in each treatment group of a two-armed study to achieve 90% power for detecting a difference in efficacy between gabapentin and bupropion.

  12. An open-label pilot study of infliximab therapy in diffuse cutaneous systemic sclerosis

    DEFF Research Database (Denmark)

    Denton, C P; Engelhart, M; Tvede, N

    2008-01-01

    AIM: The safety and potential efficacy of a chimaeric anti-tumour necrosis factor alpha monoclonal antibody (infliximab) were examined in diffuse cutaneous systemic sclerosis (dcSSc). METHODS: A 26-week open-label pilot study in which 16 cases of dcSSc received five infusions of infliximab (5 mg...... of type I collagen by dermal fibroblasts was reduced at 26 weeks compared with baseline (p = 0.02). There were no deaths during the study and no suspected unexpected serious adverse reactions. 21 serious adverse events (AE) occurred in seven subjects, mostly attributable to dcSSc. 127 distinct AE occurred...... in 16 subjects. Of these, 19 AE (15%) were probably or definitely related to infliximab treatment. Eight (50%) patients prematurely discontinued infliximab. Anti-infliximab antibodies developed during the study in five subjects and were significantly associated with suspected infusion reactions (p = 0...

  13. Dysphonia: medical treatment and a medical voice hygiene advice approach. A prospective randomised pilot study.

    Science.gov (United States)

    Pedersen, M; Beranova, A; Møller, S

    2004-07-01

    For many years all patients with dysphonia referred to in the literature as resulting from non-organic (functional) voice disorders were sent to speech therapy. Medical diagnoses were not taken into account. In our earlier Cochrane review on vocal cord nodules we discovered that evidence-based research in the area of benign voice disorders with dysphonia, and with or without slight benign swellings including nodules on the vocal cords, was lacking at that time. Therefore, a prospective randomised pilot study based on our Cochrane review has been made on dysphonic patients with non-organic (function provoked?) voice disorders as the basis for further evidence-based studies. Medical treatment was based on the scientific approach that once a micro-organic disorder caused by reflux, infection, allergy or environmental irritatants (e.g., dust or noise in the workplace) was discovered by very careful anamnesis and systematic objective routine analyses and was treated effectively, with documentation, the non-organic voice disorder disappeared, as, e.g., in the case of a diagnosis and treatment of helicobakter pylori. The reason is that the mucosal swelling/dysfunction of the vocal cords is secondary. In order to try to understand why the recommendation to all these patients for many years was only voice therapy, which the speech therapists "felt to be effective", updated voice-hygiene advice (for posture, accents of the diaphragm, intonation pattern and resonance) was given by experienced laryngologists, randomised with the updated medical diagnosis/therapy in order to elucidate what effect the training might have. No evidence-based studies in the literature document any effect. The crucial point seemed to be that doctors mostly did not examine any other diagnoses other than the "dysphonia" and did not dig down to any of the medical reasons when the vocal fold diagnosis of "non- organic disorders" was made. This should be changed in the future. This pilot study was based

  14. Is nail fold capillaroscopy useful in normotensive and primary open angle glaucoma? A pilot study.

    Science.gov (United States)

    Božić, Marija; Senćanić, Paraskeva-Hentova; Spahić, Goran; Kontić, Dorđe; Marković, Vujica; Marjanović, Ivan; Stojkovic, Milenko; Dorđević-Jocić, Jasmina

    2010-12-01

    Vascular dysregulation is deemed a significant risk factor in glaucoma occurrence and progression. Capillaroscopy of the blood vessels on the finger nail-fold is a method that can provide information regarding the state of the vascular system at the capillary level. The aim of this pilot study was to determine whether there are significant differences in the morphological characteristics of the peripheral blood vessels in normotensive glaucoma and primary open angle glaucoma. An ophthalmological and capillaroscopic examination was conducted on 30 normotensive glaucoma patients and 30 primary open angle glaucoma patients. The capillaroscopic characteristics described were as follows: capillary row density, capillary diameter, number of spirally formed capillaries, permeability of the loop, and loop resistance. Statistically, significantly more intensively spiraled capillaries were found in normotensive glaucoma patients (χ(2) test, p < 0.05). Results confirm the thesis that vascular factors play a significant role in the pathogenesis of the glaucoma, especially in cases where the level of intraocular pressure cannot be deemed responsible for the present damage of the optical nerve. Despite the newer, technologically more developed methods for diagnostics and monitoring glaucoma, it is often not easy to establish the right diagnosis and determine further the course of the illness, since the role the intraocular pressure (IOP) plays compared to the role of vascular factors is unknown; hence, capillaroscopy as a complementary diagnostic procedure can be of help.

  15. Treatment of asymptomatic vaginal candidiasis in pregnancy to prevent preterm birth: an open-label pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Kristen

    2011-03-01

    Full Text Available Abstract Background Although the connection between ascending infection and preterm birth is undisputed, research focused on finding effective treatments has been disappointing. However evidence that eradication of Candida in pregnancy may reduce the risk of preterm birth is emerging. We conducted a pilot study to assess the feasibility of conducting a large randomized controlled trial to determine whether treatment of asymptomatic candidiasis in early pregnancy reduces the incidence of preterm birth. Methods We used a prospective, randomized, open-label, blinded-endpoint (PROBE study design. Pregnant women presenting at Candida were randomized to 6-days of clotrimazole vaginal pessaries (100mg or usual care (screening result is not revealed, no treatment. The primary outcomes were the rate of asymptomatic vaginal candidiasis, participation and follow-up. The proposed primary trial outcome of spontaneous preterm birth Results Of 779 women approached, 500 (64% participated in candidiasis screening, and 98 (19.6% had asymptomatic vaginal candidiasis and were randomized to clotrimazole or usual care. Women were not inconvenienced by participation in the study, laboratory testing and medication dispensing were problem-free, and the follow-up rate was 99%. There was a tendency towards a reduction in spontaneous preterm birth among women with asymptomatic candidiasis who were treated with clotrimazole RR = 0.33, 95%CI 0.04-3.03. Conclusions A large, adequately powered, randomized trial of clotrimazole to prevent preterm birth in women with asymptomatic candidiasis is both feasible and warranted. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR: ACTRN12609001052224

  16. Functional outcomes after open versus arthroscopic Latarjet procedure: A prospective comparative study.

    Science.gov (United States)

    Nourissat, G; Neyton, L; Metais, P; Clavert, P; Villain, B; Haeni, D; Walch, G; Lafosse, L

    2016-12-01

    The Latarjet procedure provides effective stabilization of chronically unstable shoulders. Since this procedure is mainly performed in a young athletic population, the functional impact is significant. Published data does not shed light on the time needed to recover work-related or sports-related function. Performing this procedure arthroscopically may improve functional recovery. This led us to carry out a prospective, multicenter study to compare the functional recovery after arthroscopic versus open Latarjet procedure. Between June and November 2014, 184 patients were included in a prospective multicenter study: 85 in the open group and 99 in the arthroscopy group. The patients were evaluated preoperatively with the WOSI score. The early postoperative pain was evaluated on D3, D7 and D30. The WOSI score was determined postoperatively at 1, 3, 6 and 12 months of follow-up. The functional scores of the shoulder in both cohorts were identical overall preoperatively. In the immediate postoperative period, the arthroscopy group had statistically lower pain levels on D3 and D7. The postoperative WOSI was improved in both groups at 3 months, then continued to improve until it reached a plateau at 1 year. The WOSI score was better in the arthroscopy group at 3 months, but better in the open group at 6 months. This study found that a Latarjet procedure performed arthroscopically generates less immediately postoperative pain than when it is performed as an open procedure. The Latarjet procedure (whether open or arthroscopic) improves shoulder function, with normal function returning after 1 year. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

  17. Women with epilepsy initiating a progestin IUD: A prospective pilot study of safety and acceptability.

    Science.gov (United States)

    Davis, Anne R; Saadatmand, Heva J; Pack, Alison

    2016-11-01

    Effective contraception enables women with epilepsy (WWE) to plan their pregnancies and improve outcomes for themselves and their children. Although popular among all women, complex drug interactions limit the efficacy and safety of oral contraceptives (OCs) for WWE. We sought to explore the safety, acceptability, and pharmacokinetic impact of a progestin-containing intrauterine device (IUD) in WWE. We enrolled 20 women with well-controlled epilepsy and a stable antiepileptic drug (AED) regimen and who were initiating a progestin-containing IUD (levonorgestrel 52 mg) in a prospective, observational study. For each AED, we compared the trough concentration before IUD insertion to the trough concentration 3 weeks, and 3 and 6 months later. Participants recorded seizures in a daily paper diary. We compared seizures that occurred during the month before IUD insertion to those occurring in the 6 months thereafter. Participants completed an acceptability questionnaire at 3 and 6 months. Participants' average age was 28 years; 60% were nulligravid. They reported a history of multiple seizure types. During the baseline month, 75% were seizure-free and the remainder reported between one and three seizures. Fourteen received monotherapy and six received polytherapy. Lamotrigine use was most common (n = 12). AED trough concentrations remained stable during the 6 months after IUD insertion, without clinically meaningful deviations from baseline. Diary data showed that seizure frequency worsened in 3, and remained unchanged in 13 and improved in 4 after IUD insertion. Subjectively, no participant believed the IUD worsened her seizure control. All participants were either somewhat or very satisfied with the IUD throughout the study. All participants continued the IUD use at 6 months. No pregnancies occurred. This pilot study suggests that the progestin-containing IUD is a safe and acceptable long-acting contraceptive for WWE. Wiley Periodicals, Inc. © 2016 International League

  18. Metronomic therapy with oral 6-mercaptopurine in elderly acute myeloid leukemia: A prospective pilot study

    Directory of Open Access Journals (Sweden)

    Akhil Kapoor

    2016-01-01

    Full Text Available Introduction: Acute myeloid leukemia (AML in elderly patients differs biologically from that in younger patients and is known to have unfavorable chromosomal rearrangements, higher resistance, and lower tolerance to chemotherapy. In such circumstances, instead of giving full-blown chemotherapy, palliative metronomic chemotherapy (MCT could be a treatment option. Patients and Methods: We performed a prospective pilot study of old AML patients (age >60 years not amenable to curative treatment. Thirty-two patients were enrolled into the study and were treated with daily oral 6-mercaptopurine 75 mg/m 2 . The following inclusion criteria were used: age >60 years, nonpromyelocytic AML, the absence of uncontrolled comorbidities, and patient not amenable to curative treatment. Overall survival (OS was calculated using Kaplan-Meier method and Cox regression analysis were used to calculate the hazards ratio of significant factors. Results: The median age of the patients was 69 years (range: 61-86 years with male: female ratio of 2.5:1. About 59.4% of patients had Eastern Cooperative Oncology Group performance status of 2 while rest had the status of 3. The median OS was 6 months (95% confidence interval [CI]: 4.4-7.6. Males had median OS of 7 months (95% CI: 5.4-8.6 versus females with OS of 3 months (95% CI: 1.5-4.4; P = 0.008. There was no survival difference on the basis of baseline hemoglobin or French-American-British class. There were no Grade 4 toxicities and no episode of febrile neutropenia. Conclusions: MCT with oral 6-mercaptopurine is an attractive treatment option in elderly AML patients who are not amenable to curative therapy with minimal toxicities.

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

    Science.gov (United States)

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

    2016-01-01

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

  20. PROSPECTIVE COMPARISON OF ENDOSCOPIC AND OPEN SURGICAL METHODS FOR CARPAL TUNNEL SYNDROME

    Institute of Scientific and Technical Information of China (English)

    Ye Tian; Hong Zhao; Ting Wang

    2007-01-01

    Objective To compare outcomes of patients undergoing either open or endoscopic carpal tunnel release for the treatment of idiopathic carpal tunnel syndrome.Methods A prospective, randomized study was performed on 70 hands in 62 patients with idiopathic carpal tunnel syndrome from April 2000 to April 2004. Either open (36 hands in 30 patients) or endoscopic (34 hands in 32 patients) carpal tunnel release was performed randomly. Symptom improvement, complications, and the time of operation , in-hospital stay, and return to work between the two groups were assessed with average 2 years of follow-up. The electromyography was tested pre- and 3 months post-operation.Results There were no significant differences between the two surgical groups with regard to postoperative improvements of symptom, electromyography tests, and the incidence of complications. But it was statistically less in the rate of scar tenderness, the time of operation, in-hospital stay, and return to work in the endoscopic group compared with the open group (P< 0. 05).Conclusions The endoscopic carpal tunnel release is a reliable method in the treatment of idiopathic carpal tunnel syndrome. And it has the advantages of slight scar tenderness, less operation time, less in-hospital stay, early functional recovery, safety, and high satisfaction rate compared with open methods.

  1. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    Science.gov (United States)

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  2. Leflunomide treatment in corticosteroid-dependent myasthenia gravis: an open-label pilot study.

    Science.gov (United States)

    Chen, Pei; Feng, Huiyu; Deng, Juan; Luo, Yufei; Qiu, Li; Ou, Changyi; Liu, Weibin

    2016-01-01

    Leflunomide is an effective drug used in the treatment of rheumatoid arthritis. Here we report the findings of an open-label pilot study, which found that leflunomide is also an effective treatment for myasthenia gravis (MG). This study recruited 15 corticosteroid-dependent MG patients. For 6 months, leflunomide 20 mg was given to these patients daily along with prednisone. The quantitative myasthenia gravis (QMG) scores and MG activities of daily living (MG-ADL) profiles were measured in these MG patients. After 6 months of treatment, 9 of the 15 patients enrolled in this study showed improvements in both QMG and MG-ADL. The mean QMG scores (13.4 to 8.5) and MG-ADL profiles (5.8 to 2.8) were significantly decreased (P = 0.01, 0.006 respectively). Furthermore, we found that the mean corticosteroid doses were reduced after treatment with leflunomide (24.3 to 12.3 mg per day). Leflunomide is a well-tolerated and efficacious treatment for corticosteroid-dependent MG, which may also enable lower doses of corticosteroids to be administered.

  3. PROSPECTIVE AND COMPARATIVE STUDY ON FUNCTIONAL OUTCOMES AFTER OPEN AND ARTHROSCOPIC REPAIR OF ROTATOR CUFF TEARS

    Science.gov (United States)

    de Castro Veado, Marco Antônio; Castilho, Rodrigo Simões; Maia, Philipe Eduardo Carvalho; Rodrigues, Alessandro Ulhôa

    2015-01-01

    Objective: To prospectively assess the surgical results from patients undergoing repairs to rotator cuff injuries via open and arthroscopic procedures, with regard to functional and clinical features, and by means of ultrasound examinations, and to compare occurrences of renewed tearing. Methods: Sixty patients underwent operations performed by the same surgeon (29 via open surgery and 31 via arthroscopy), to repair complete rotator cuff tears. The procedures were performed at Hospital Governor Israel Pinheiro (HGIP) and Mater Dei Hospital in Belo Horizonte, Minas Gerais, between August 2007 and February 2009. The patients were assessed functionally by means of the UCLA score before and after the operation, and magnetic resonance imaging was done before the operation. All the patients were reassessed at least 12 months after the operation, and an ultrasound examination was also performed at this time. Results: Out of the 29 patients who underwent open surgery, 27 (93.1%) presented good or excellent results, with a mean UCLA score of 32 after the operation. Their mean follow-up was 14 months. Three patients presented renewed tearing on ultrasound, of whom one remained asymptomatic. Out of the 31 patients who underwent arthroscopic procedures, 29 (93.5%) presented good or excellent results, with a mean UCLA score of 33 after the operation. Their mean follow-up was 19 months. Two patients presented renewed tearing, of whom one remained asymptomatic and one evolved with loosening of an anchor, with an unsatisfactory result. Conclusion: The repairs on rotator cuff injuries presented good results by means of both open surgery and arthroscopy, with similar functional results in the two groups and similar rates of renewed tearing. PMID:27027052

  4. Ambulatory open Bankart repair under a single general anesthesia: a prospective study of the immediate outcome.

    Science.gov (United States)

    Molina, Véronique; Gagey, Olivier; Langloÿs, Joel

    2006-01-01

    The interscalenic block technique is widely used for ambulatory shoulder surgery despite a substantial number of failures and adverse effects. We prospectively evaluated satisfaction in 40 consecutive patients who underwent open Bankart repair under a single general anesthesic performed in an ambulatory care unit. The mean age of the patients was 23 years. There were 29 men and 11 women. Patients were evaluated postoperatively with a visual analog scale of pain (in the recovery room, at the time of discharge, and the day after and 1 week after surgery) via a home assessment questionnaire that included the following: effectiveness of oral pain medication, ability to perform activities of daily life, and overall satisfaction. One patient failed to be discharged because of a feeling of faintness not related to pain. None of the 39 patients would have preferred an overnight hospital stay. This study confirms that the open Bankart procedure is feasible as a same-day technique and indicates that a single anesthesic with proper management of analgesia is a reliable technique for major shoulder surgery in an ambulatory care unit.

  5. Towards Farm-Oriented Open Data in Europe: the Scope and Pilots of the European Project "FOODIE"

    Directory of Open Access Journals (Sweden)

    T. Řezník

    2015-03-01

    Full Text Available The different groups of stakeholders involved in the agricultural activities have to manage many different and heterogeneous sources of information that need to be combined in order to make economically and environmentally sound decisions, which include (among others the definition of policies (subsidies, standardisation and regulation, national strategies for rural development, climate change, development of sustainable agriculture, harvest timing and yield estimation, crop damages detection, etc. The European project called “Farm-Oriented Open Data in Europe” with abbreviation "FOODIE", funded between years 2014 and 2017 addresses the above mentioned issues. This paper describes the scope of the project with emphasis on its pilots. The Czech pilot is then analysed in detail including its three scenarios: Improving efficiency of transport in agriculture, Telematics of farm machinery and Monitoring of in-field variability for site specific crop management.

  6. [Laparoscopic inguinal hernia repair "IPOM" vs "open tension free". Preliminary results of a prospective randomized study].

    Science.gov (United States)

    Catani, M; De Milito, R; Spaziani, E; Chiaretti, M; Manili, G; Capitano, S; Di Filippo, A; Simi, M

    2003-12-01

    The authors report the preliminary results of a prospective comparison of IPOM (group A) and "open tension free" (group B) hernioplasty in 50 patients having a mono or bilateral primitive hernia. In group A (26 patients) hernia repair was performed using "Gore-Tex DualMesh Plus biomaterial with holes Corduroy" and in group B (24 patients) using the patch and plug technique with Marlex prosthesis. No intraoperative complications occurred and, in group A, no conversion was necessary. Four minor complications were obser-ved in group A (10.8%): 3 seromas and 1 transient paresthesia; 5 in group B (16%): 4 hematomas and 1 wound infection (p=n.s.). In group A only 2 patients (7.6%) needed analgesics after the first 24 hours and 12 patients (50%) in group B (p<0.001). Mean resumption of normal activity was 8 days in group A and 17 days in group B (p<0.001). At a 12-month-follow-up, no recurrence was reported in both groups. The results of this prospective randomized study show that IPOM may be not only a feasible and effective procedure in the treatment of recurrent and bilateral hernia or when hernia repair is performed during other laparoscopic procedures, but also in particular cases of primitive hernia such as in very active young males or heavy duty workers. However it is necessary to definitely ascertain the true incidence of recurrence in non limited series and in longer follow-up and the preliminary results of this study encourage the authors to complete the randomized study.

  7. Transgender Day of Remembrance and a Prospective Student Open House: How One Student Inspired a School to Do Both

    Science.gov (United States)

    Fusarelli, Bonnie C.; Eaton, Lucy E.

    2011-01-01

    This case study explores the challenges a school leader faced when her commitment to diversity was tested by a scheduling conflict. The school principal approved a Transgender Day of Remembrance but then realized that it was scheduled for the same night as the school's Open House to recruit prospective students. The case study provides an…

  8. Design of pilot-assisted load control valve with load velocity control ability and fast opening feature

    Directory of Open Access Journals (Sweden)

    Haibo Xie

    2015-11-01

    Full Text Available This article presents a design of pilot-assisted load control valve with load velocity control ability and fast opening feature based on static and dynamic modeling. Traditional load control valves do not have the load velocity control ability and its opening feature is very poor because the high spring stiffness comes along with the pressure–spring balance–based principle. Some improvement has been done by employing a two-stage pressure–pressure balance principle to make a load control valve to achieve load velocity control ability while the opening feature was not improved much. In this design, another pressure–pressure balance principle is proposed to make the load control valve achieve load velocity control ability and fast opening closing feature at the same time. Static modeling method based on force balance and Bernoulli orifice pressure-flow equation is used to design the load velocity control ability of the valve. Dynamic modeling method based on Newton’s second law and fluid continuity equation is used to optimize the parameters to give the proposed load control valve a fast opening feature. An actual load control valve was developed according to the above methods and the test results show both good load velocity control ability and fast opening feature of the design, which validates the potentiality of the proposed design in many applications.

  9. Prospects for pilot plants based on the tokamak, spherical tokamak and stellarator

    Science.gov (United States)

    Menard, J. E.; Bromberg, L.; Brown, T.; Burgess, T.; Dix, D.; El-Guebaly, L.; Gerrity, T.; Goldston, R. J.; Hawryluk, R. J.; Kastner, R.; Kessel, C.; Malang, S.; Minervini, J.; Neilson, G. H.; Neumeyer, C. L.; Prager, S.; Sawan, M.; Sheffield, J.; Sternlieb, A.; Waganer, L.; Whyte, D.; Zarnstorff, M.

    2011-10-01

    A potentially attractive next-step towards fusion commercialization is a pilot plant, i.e. a device ultimately capable of small net electricity production in as compact a facility as possible and in a configuration scalable to a full-size power plant. A key capability for a pilot-plant programme is the production of high neutron fluence enabling fusion nuclear science and technology (FNST) research. It is found that for physics and technology assumptions between those assumed for ITER and nth-of-a-kind fusion power plant, it is possible to provide FNST-relevant neutron wall loading in pilot devices. Thus, it may be possible to utilize a single facility to perform FNST research utilizing reactor-relevant plasma, blanket, coil and auxiliary systems and maintenance schemes while also targeting net electricity production. In this paper three configurations for a pilot plant are considered: the advanced tokamak, spherical tokamak and compact stellarator. A range of configuration issues is considered including: radial build and blanket design, magnet systems, maintenance schemes, tritium consumption and self-sufficiency, physics scenarios and a brief assessment of research needs for the configurations.

  10. A prospective open-label trial of lamotrigine monotherapy in children and adolescents with bipolar disorder.

    Science.gov (United States)

    Biederman, Joseph; Joshi, Gagan; Mick, Eric; Doyle, Robert; Georgiopoulos, Anna; Hammerness, Paul; Kotarski, Meghan; Williams, Courtney; Wozniak, Janet

    2010-04-01

    To evaluate the safety and efficacy of lamotrigine monotherapy as an acute treatment of bipolar mood elevation in children with bipolar spectrum disorders. This was a 12-week, open-label, prospective trial of lamotrigine monotherapy to assess the effectiveness and tolerability of this compound in treating pediatric bipolar disorder. Assessments included the Young Mania Rating Scale (YMRS), Clinical Global Impressions-Improvement scale (CGI-I), Children's Depression Rating Scale (CDRS), and Brief Psychiatric Rating Scale (BPRS). Adverse events were assessed through spontaneous self-reports, vital signs weight monitoring, and laboratory analysis. Thirty-nine children with bipolar disorder (YMRS at entry: 31.6 +/- 5.5) were enrolled in the study and 22 (56%) completed the 12-week trial. Lamotrigine was slowly titrated to an average endpoint dose of 160.7 +/- 128.3 in subjects children 12-17 years of age (N = 17). Treatment with lamotrigine was associated with statistically significant levels of improvement in mean YMRS scores (-14.9 +/- 9.7, P disorder (ADHD), and psychotic symptoms. Lamotrigine was generally well tolerated with marginal increase in body weight (47.0 +/- 18.0 kg vs. 47.2 +/- 17.9 kg, P= 0.6) and was not associated with abnormal changes in laboratory parameters. Several participants were discontinued due to skin rash; in all cases, the rash resolved shortly after discontinuation of treatment. No patient developed Steven Johnson syndrome. Open-label lamotrigine treatment appears to be beneficial in the treatment of bipolar disorder and associated conditions in children. Future placebo-controlled, double-blind studies are warranted to confirm these findings.

  11. Homoeopathic management of Schizophrenia: A prospective, non-comparative, open-label observational study

    Directory of Open Access Journals (Sweden)

    Praveen Oberai

    2016-01-01

    Full Text Available Objectives: To evaluate the usefulness of homoeopathic intervention in Schizophrenia, in untreated cases and antipsychotic treatment resistant cases, to verify indications of medicines, and to assess relapse, if any. Materials and Methods: A prospective, non-comparative, open-label observational study was carried out from October 2005-September 2010 by CCRH at Central Research Institute (H, Kottayam, Kerala, India. Patients between 20 and 60 years of age, presenting with symptoms of Schizophrenia were screened for inclusion and exclusion criteria. The patients who were on antipsychotic drugs were allowed to continue the same along with homoeopathic medicine, the dose of antipsychotics was monitored by the Psychiatrist. The symptoms of each patient were repertorized, and medicine was initially prescribed in 30C potency after consulting Materia Medica. Patients were followed up for 12 months. Outcome of treatment was assessed with Brief Psychiatric Rating Scales (BPRS. Analysis was done using Statistical Package for the Social Sciences  SPSS Version 20.0. Results: Out of 188 enrolled patients, 17 cases did not complete the baseline information. Total 171 patients were analysed as per modified Intention to Treat Principle. Significant difference (P = 0.0001, P < 0.05 in the mean scores of BPRS, using paired t test was observed at end of the study. Sulphur, Lycopodium, Natrum muriaticum, Pulsatilla and Phosphorus were found to be the most useful medicines in treating schizophrenic patients. Conclusion: The study reflects the positive role of homoeopathic medicines in the management of patients suffering from schizophrenia as measured by BPRS.

  12. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    Science.gov (United States)

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

  13. A prospective 3-year follow-up trial of implantation of two trabecular microbypass stents in open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Donnenfeld ED

    2015-11-01

    Full Text Available Eric D Donnenfeld,1 Kerry D Solomon,2 Lilit Voskanyan,3 David F Chang,4 Thomas W Samuelson,5 Iqbal Ike K Ahmed,6 L Jay Katz7 1Ophthalmic Consultants of Long Island, Rockville Centre, NY, 2Carolina Eyecare Physicians, Mt Pleasant, SC, USA; 3S.V. Malayan Ophthalmology Centre, Yerevan, Armenia; 4Altos Eye Physicians, Los Altos, CA, 5Minnesota Eye Consultants, Minneapolis, MN, USA; 6University of Toronto, Toronto, ON, Canada; 7Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA Purpose: To evaluate 3-year safety and intraocular pressure (IOP following two trabecular microbypass stents in phakic and pseudophakic subjects with open-angle glaucoma (OAG not controlled on preoperative medication. Patients and methods: In this prospective pilot study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 30 mmHg on one preoperative topical ocular hypotensive medication underwent medication washout. Thirty-nine qualified subjects with preoperative unmedicated IOP ≥22 mmHg and ≤38 mmHg received two stents. Postoperative examinations were scheduled at Day 1, Week 1, Months 1, 3, 6, and 12, and semiannually through Month 60. Ocular hypotensive medication was considered if postoperative IOP exceeded 21 mmHg. IOP, medication use, and safety were assessed at each visit. Subject follow-up through Month 36 was completed. Results: Thirty-six eyes (92.3%; 95% confidence interval [CI] 79.1%, 98.4% achieved the primary efficacy end point of Month 12 reduction in IOP ≥20% from baseline (unmedicated IOP without ocular hypotensive medication. Four subjects required medication during the Month 36 follow-up period. Mean IOP at 36 months for subjects not taking medication was 15.2 mmHg. At 36 months, subjects sustained mean IOP decrease of 9.1±2.7 mmHg (95% CI 8.0 mmHg, 10.14 mmHg, or 37% IOP reduction, from unmedicated baseline IOP. Compared to preoperative medicated IOP, subjects had mean reduction at Month 36 of 5.5±2

  14. Treatment of hemorrhoids with individualized homeopathy: An open observational pilot study

    Science.gov (United States)

    Das, Kaushik Deb; Ghosh, Shubhamoy; Das, Asim Kumar; Ghosh, Aloke; Mondal, Ramkumar; Banerjee, Tanapa; Ali, Seikh Sajid; Ali, Seikh Swaif; Koley, Munmun; Saha, Subhranil

    2016-01-01

    Aim: Controversies and disagreement exist on conventional treatment strategies of hemorrhoids due to relapse, inefficacy, and complications. We intend to evaluate the role of individualized homeopathic treatment in hemorrhoids. Materials and Methods: In this prospective, open, observational trial, hemorrhoids patients were treated using five standardized scales measuring complaints severity and anoscopic score. It was conducted at two homeopathic hospitals in India, during from mid-July 2014 to mid-July 2015. Patients were intervened as per individualized homeopathic principles and followed up every month up to 6 months. Results: Total 73 were screened, 52 enrolled, 38 completed, 14 dropped out. Intention to treat population (n: = 52) was analyzed in the end. Statistically significant reductions of mean bleeding (month 3: −21.8, 95% confidence interval [CI]: −30.3, −13.3, P: < 0.00001, d = 0.787; month 6: −25.5, 95% CI −35.4, −15.6, P: < 0.00001, d = 0.775), pain (month 3: −21.3, 95% CI −28.6, −14.0, P: < 0.00001, d = 0.851; month 6: −27.6, 95% CI −35.6, −19.6, P: < 0.00001, d = 1.003), heaviness visual analog scales (VASs) (month 3: −8.1, 95% CI −13.9, −2.3, P: = 0.008, d = 0.609; month 6: −12.1, 95% CI −19.1, −5.1, P: = 0.001, d = 0.693), and anoscopic score (month 3: −0.4, 95% CI −0.6, −0.2, P: < 0.0001, d = 0.760; month 6: −0.5, 95% CI −0.7, −0.3, P: < 0.0001, d = 0.703) were achieved. Itching VASs reduced significantly only after 6 months (−8.1, 95% CI −14.6, −1.6, P: = 0.017, d = 0.586). No significant lowering of discharge VASs was achieved after 3 and 6 months. Conclusion: Under classical homeopathic treatment, hemorrhoids patients improved considerably in symptoms severity and anoscopic scores. However, being observational trial, our study cannot provide efficacy data. Controlled studies are required. Trial Reg. CTRI/2015/07/005958. PMID:27757262

  15. The Effect of a Unique Pacifier on Anterior Open Bite and Overjet in the Primary Dentition: A Pilot Study.

    Science.gov (United States)

    Nowak, Arthur J; Kim, Amy S; Scott, Jo Anna M; Berg, Joel H

    2016-01-01

    Pacifiers are the most common device used by children to satisfy their sucking needs. Because of their design, reports of anterior open bite and increased overjet are common. The purposes of this pilot study were to measure the effects of a unique pacifier in toddlers who have existing open bites and increased overjets; and secondly to determine the feasibility of recruiting and retaining toddlers for a six-month study. Toddlers with existing open bite and increased overjet currently using a conventional pacifier were recruited from a university pediatric dental clinic. Baseline information was obtained. Visual examination and intraoral measurements were obtained. The study pacifier was introduced to replace the existing pacifier. Follow-up data was collected at three and six months post-intervention. Eight of the 11 toddlers (73 percent) completed the study. Recruitment was challenging because of the inclusion criteria and transportation; retaining participants required numerous reminders to parents. There was a significant difference between initial and final open bite and overjet measurements. It is feasible to recruit and retain toddlers but it required significant staff interventions. There was a significant improvement in reducing existing open bite and overjet with the pacifier after six months.

  16. Electronic brachytherapy for superficial and nodular basal cell carcinoma: a report of two prospective pilot trials using different doses

    Directory of Open Access Journals (Sweden)

    Rosa Ballester-Sánchez

    2016-01-01

    Full Text Available Purpose : Basal cell carcinoma (BCC is a very common cancer in the Caucasian population. Treatment aims to eradicate the tumor with the lowest possible functional and aesthetic impact. Electronic brachytherapy (EBT is a treatment technique currently emerging. This study aims to show the outcomes of two consecutive prospective pilot clinical trials using different radiation doses of EBT with Esteya® EB system for the treatment of superficial and nodular basal cell carcinoma. Material and methods : Two prospective, single-center, non-randomized, pilot studies were conducted. Twenty patients were treated in each study with different doses. The first group (1 was treated with 36.6 Gy in 6 fractions of 6.1 Gy, and the second group (2 with 42 Gy in 6 fractions of 7 Gy. Cure rate, acute toxicity, and late toxicity related to cosmesis were analyzed in the two treatment groups. Results: In group 1, a complete response in 90% of cases was observed at the first year of follow-up, whereas in group 2, the complete response was 95%. The differences with reference to acute toxicity and the cosmetic results between the two treatment groups were not statistically significant. Conclusions : Our initial experience with Esteya® EB system to treat superficial and nodular BCC shows that a dose of 36.6 Gy and 42 Gy delivered in 6 fraction of 7 Gy achieves a 90% and 95% clinical cure rate at 1 year, respectively. Both groups had a tolerable toxicity and a very good cosmesis. The role of EBT in the treatment of BCC is still to be defined. It will probably become an established option for selected patients in the near future.

  17. Open-Trial Pilot of "Mind Reading" and in Vivo Rehearsal for Children with HFASD

    Science.gov (United States)

    Thomeer, Marcus L.; Rodgers, Jonathan D.; Lopata, Christopher; McDonald, Christin A.; Volker, Martin A.; Toomey, Jennifer A.; Smith, Rachael A.; Gullo, Gaetano

    2011-01-01

    In this pilot study, the authors evaluated a manualized administration of the "Mind Reading" (MR) program with in vivo rehearsal to determine the effects on emotion recognition and autism features of eleven 7- to 12-year-old children with High-Functioning Autism Spectrum Disorders (HFASD), and to determine the overall feasibility of the…

  18. Rotorcraft pilot coupling susceptibility accompanying handling qualities prospects in preliminary rotorcraft design.

    OpenAIRE

    Yilmaz, D; Dang Vu, B.; M. Jones

    2012-01-01

    Due to expensive and risky Rotorcraft-Pilot Couplings (RPC) that can develop during flight testing phases of any new prototype aircraft, it is beneficial to crosscheck the RPC susceptibility of the vehicle as early as possible during the design process. One of the objectives of the European project ARISTOTEL (2010-2013) is to provide guidelines to designers and simulator programs to reveal RPC aspects of the vehicle to be designed. First, a methodology to assess the sensitivity of Handling Qu...

  19. Re: Prospective Pilot Study of Mirabegron in Pediatric Patients with Overactive Bladder

    Directory of Open Access Journals (Sweden)

    Sinharib Çitgez

    2016-12-01

    Full Text Available EDITORIAL COMMENT Overactive bladder (OAB is a highly prevalent disorder in the pediatric population. This event negatively affects and impairs children’s development. Antimuscarinics are the mainstay pharmacological management of OAB, but their side effects profile limits their use. Mirabegron, a new molecule with a distinct mechanism of action (b3-adrenoreceptor agonist, was recently approved as monotherapy for idiopathic OAB in adults but has not been studied in the pediatric population. Blais et al. have evaluated the efficacy and safety of mirabegron in the treatment of urinary incontinence in children with idiopathic OAB who were refractory to and/or intolerant of antimuscarinics. This prospective off-label study, using an adjusted-dose regimen of mirabegron (25-50 mg, included pediatric patients with refractory urinary incontinence due to OAB. Patients without symptom improvement or with partial response under intensive behavioral protocol and medical therapy (at least two different antimuscarinic agents were included in the study. Their primary outcome was better reported efficacy than with the use of prior anticholinergic medication. Secondary end points were tolerability and safety. Families were questioned for continence, side effects, compliance, and Patient Perception of Bladder Condition (PPBC questionnaire. A total of 58 patients (14 girls, 44 boys were enrolled in a mirabegron open-label trial. The median age at initiation of mirabegron was 10.1 years [interquartile range (IQR: 8.8-13.5]. The median duration of treatment was 11.5 months (IQR: 6.0-15.0. The median bladder capacity improved from 150 ml to 200 ml (p<0.001. Continence improved in 52 of 58, with 13 being completely dry. The median PPBC score improved from 4.0 to 2.0 (p<0.001. The authors also assessed the safety of mirabegron. All electrocardiogram and blood tests remained normal. No significant change in blood pressure (<5 mmHg and heart rate (fewer than five beats

  20. Laparoscopic versus open nephroureterectomy: perioperative and oncologic outcomes from a randomised prospective study.

    Science.gov (United States)

    Simone, Giuseppe; Papalia, Rocco; Guaglianone, Salvatore; Ferriero, Mariaconsiglia; Leonardo, Costantino; Forastiere, Ester; Gallucci, Michele

    2009-09-01

    Laparoscopic nephroureterectomy (LNU) is increasingly being used instead of open nephroureterectomy (ONU) for the treatment of urothelial carcinoma (UC) of the upper urinary tract (UUT), but the evidence of equal oncologic effectiveness is still lacking. To present perioperative and oncologic results from a prospective randomised study comparing ONU and LNU. Eighty patients with nonmetastatic UUT UC and without previous history of UC were enrolled. Of those, 40 patients (group A) randomly received ONU and 40 patients (group B) randomly received LNU. ONU was performed through a flank incision with a lower quadrant incision to allow excision of a bladder cuff. Transperitoneal LNU was performed with a four-trocar technique, and bladder cuff was detached with a 10-mm LigaSure device. Perioperative data were compared with the student t test. Bladder tumour-free survival (BTFS), metastasis-free survival (MFS), and cancer-specific survival (CSS) curves for both groups were compared with the log-rank test before and after stratifying patients for pT category and tumour grade. Operative times were comparable, while mean blood loss and mean time to discharge were significantly lower in group B (both p values ONU (p=0.039 and p=0.004, respectively, for pT3 tumours; p=0.078 and p=0.014, respectively, for high-grade tumours). The limitations of our study include the small sample size, the single-centre experience, the personal choice of laparoscopic technique, and not performing lymphadenectomies. Perioperative data and preliminary oncologic results were presented at 22nd Congress of the European Association of Urology, Berlin, Germany. In patients with organ-confined UUT UCs, LNU has the advantages of minimal invasiveness and oncologic outcomes comparable to those of ONU, while its effectiveness in patients with advanced stage diseases remains to be proven.

  1. Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study

    OpenAIRE

    Turchetti, Giuseppe; Pierotti, Francesca; Palla, Ilaria; Manetti, Stefania; Freschi, Cinzia; Ferrari, Vincenzo; Cuschieri, Alfred

    2016-01-01

    Background 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). Methods The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italia...

  2. Efficacy and safety of tolterodine in subjects with symptoms of overactive bladder: An open label, noncomparative, prospective, multicentric study

    OpenAIRE

    Anant Kumar

    2002-01-01

    Objective: To evaluate the clinical efficacy and safety of Tolterodine 2 mg twice daily in Indian subjects with symptoms of overactive bladder including frequency, ur-gency with or without urge incontinence. Methods: This multicentric open-label, noncompara-tive, prospective study was conducted at 7 centers across India. Eligible patients were assigned to treatment with Tab. Tolterodine 2 mg twice daily for 8 weeks. Subjects were seen at visit ](day 3 to 10), visit 2 (day 1) and after 8...

  3. Fraturas expostas: estudo epidemiológico e prospectivo Open fractures: prospective and epidemiological study

    Directory of Open Access Journals (Sweden)

    Luciano Rodrigo Peres Arruda

    2009-01-01

    Full Text Available OBJETIVO: Traçar o perfil epidemiológico dos pacientes atendidos em uma unidade de urgência com diagnóstico de fratura exposta. MATERIAIS E MÉTODOS: O trabalho é do tipo epidemiológico, prospectivo, descritivo, observacional, das fraturas expostas atendidas por amostra de conveniência na instituição, no período de 1 setembro de 2005 a 31 de março de 2007. A coleta dos dados foi através de questionário com diversas variáveis. RESULTADOS: Obtivemos 342 pacientes portadores de 346 fraturas, sendo a maioria do sexo masculino (86,84%, com idade média de 30,41 anos e tempo médio de internação de 6,87 dias. As profissões encontradas foram os estudantes (21,92%, seguido dos "motoboys" (11,40%. Os acidentes ocorreram em vias públicas (57,30%, acometendo os ossos da perna (37,86% e classificadas como grau III (45,36%. Lesões associadas ocorreram em 27,19%, apresentando 11,11% de complicações. Houve consumo de bebida alcoólica (12,86% e drogas (1,46% nas 6 horas que antecederam o trauma. CONCLUSÃO: Houve o predomínio do paciente jovem do sexo masculino, com ensino fundamental incompleto, acidentes de trânsito, no período das 19hs às 0hs, acometendo os ossos da perna e classificadas como grau III. As lesões associadas e complicações precoces estão mais relacionadas às lesões de maior gravidade.OBJECTIVE: to delineate the epidemiological profile of patients attended by an emergency unit, diagnosed with open fractures. MATERIALS AND METHODS: This is an epidemiological, prospective, descriptive, observational study of open fractures attended at the institution, selected by convenience sampling, in the period September 1, 2005 to March 31, 2007. The data were collected from patients using a questionnaire with multiple variables. RESULTS: we obtained 342 patients with 346 open fractures. The majority of the patients were male (86.84%, with an average age of 30.41 years and average hospitalization time of 6.87 days. The main

  4. A framework for prospectively defining progression rules for internal pilot studies monitoring recruitment.

    Science.gov (United States)

    Hampson, Lisa V; Williamson, Paula R; Wilby, Martin J; Jaki, Thomas

    2017-01-01

    Just over half of publicly funded trials recruit their target sample size within the planned study duration. When recruitment targets are missed, the funder of a trial is faced with the decision of either committing further resources to the study or risk that a worthwhile treatment effect may be missed by an underpowered final analysis. To avoid this challenging situation, when there is insufficient prior evidence to support predicted recruitment rates, funders now require feasibility assessments to be performed in the early stages of trials. Progression criteria are usually specified and agreed with the funder ahead of time. To date, however, the progression rules used are typically ad hoc. In addition, rules routinely permit adaptations to recruitment strategies but do not stipulate criteria for evaluating their effectiveness. In this paper, we develop a framework for planning and designing internal pilot studies which permit a trial to be stopped early if recruitment is disappointing or to continue to full recruitment if enrolment during the feasibility phase is adequate. This framework enables a progression rule to be pre-specified and agreed upon prior to starting a trial. The novel two-stage designs stipulate that if neither of these situations arises, adaptations to recruitment should be made and subsequently evaluated to establish whether they have been successful. We derive optimal progression rules for internal pilot studies which minimise the expected trial overrun and maintain a high probability of completing the study when the recruitment rate is adequate. The advantages of this procedure are illustrated using a real trial example.

  5. Systemic inflammatory responses during laparoscopic and open inguinal hernia repair: a randomised prospective study

    DEFF Research Database (Denmark)

    Jess, P; Schultz, Karen; Bendtzen, K

    2000-01-01

    To see if the inflammatory responses during and after laparoscopic and open inguinal hernia repairs differed.......To see if the inflammatory responses during and after laparoscopic and open inguinal hernia repairs differed....

  6. Prognostic Importance of Lesion Location on Functional Outcome in Patients with Cerebellar Ischemic Stroke: a Prospective Pilot Study.

    Science.gov (United States)

    Picelli, Alessandro; Zuccher, Paola; Tomelleri, Giampaolo; Bovi, Paolo; Moretto, Giuseppe; Waldner, Andreas; Saltuari, Leopold; Smania, Nicola

    2017-02-01

    To date, few studies focused on prediction of functional recovery after cerebellar stroke. The main aim of this prospective pilot study was to determine the association between cerebellar lesion location and functional outcome in adults with acute cerebellar infarction. We examined 14 patients with first-ever unilateral cerebellar ischemic stroke within 7 days and at 90 days from the onset of stroke by means of the International Cooperative Ataxia Rating Scale. Cerebellar lesions were traced from magnetic resonance imaging performed within 72 h since stroke and region of interest were generated. The association between the International Cooperative Ataxia Rating Scale score and lesion location was determined with the voxel-based lesion-symptom mapping methods implemented in the MRIcro software. Colored lesion-symptom maps representing the z statistics were generated and overlaid onto the MNI-ICBM 152 linear probabilistic atlas of the human brain and the Johns Hopkins University white matter templates. Our results documented that injuries to the V, VI, VIIA Crus I, VIIA Crus II, VIIB, VIIIA, and VIIIB lobules and the middle cerebellar peduncle are significantly associated with the International Cooperative Ataxia Rating Scale (ICARS) score at 1 week after the onset of stroke. Furthermore, we found that injuries to the VI, VIIA Crus I, VIIA Crus II, VIIB, VIIIA, and VIIIB lobules, the dentate nucleus, and the middle cerebellar peduncle are significantly associated with the ICARS score at 3 months since the cerebellar stroke onset. The findings of this pilot study might improve prognostic accuracy of functional outcome in patients with acute cerebellar infarction.

  7. SU-E-T-65: A Prospective Trial of Open Face Masks for Head and Neck Radiotherapy

    Energy Technology Data Exchange (ETDEWEB)

    Wiant, D; Squire, S; Maurer, J; Liu, H; Hayes, L; Sintay, B [Cone Health Cancer Center, Greensboro, NC (United States)

    2015-06-15

    Purpose: Open face head and neck masks allow for active patient monitoring during treatment and may reduced claustrophobia and anxiety compared to closed masks. The ability of open masks to limit intrafraction motion and to preserve the patient shape/position from simulation over protracted treatments should be considered. Methods: Thirty-two head and neck patients were prospectively randomized to treatment in a closed mask or a novel open face mask. All patients received daily volumetric imaging. The daily images were automatically rigidly registered to the planning CT’s offline using a commercial image processing tool. The shifts needed to optimize the registration, the mutual information coefficient (MI), and the Pearson correlation (PC) coefficients were recorded to evaluate shape preservation. The open group was set-up and monitored with surface imaging at treatment. The real time surface imaging information was recorded to evaluate intrafraction motion. Results: Sixteen patients were included in each group. Evaluations were made over a total of 984 fractions. The mean MI and PC showed significantly higher shape preservation for the open group than for the closed group (p = 0). The mean rotations for the open group were smaller or < 0.15° larger versus the closed group. The mean intrafraction motion for the open group was 0.93 +/−0.99 mm (2 SD). The maximum single fraction displacement was 3.2 mm. Fourteen of 16 patients showed no significant correlation of motion with fraction number (p > 0.05). Conclusion: The open masks preserved shape as well as the closed masks, and they limited motion to < 2 mm for 95% of the treated fractions. These results are consistent over treatment courses of up to 35 fractions. The open mask is suitable for treatment with or without active monitoring. This work was partially supported by Qfix.

  8. Prospective pilot trial of dexmedetomidine sedation for awake diagnostic flexible bronchoscopy.

    Science.gov (United States)

    Lee, Keat; Orme, Ruari; Williams, Daryl; Segal, Reny

    2010-10-01

    Dexmedetomidine has the favorable properties of sedation, sympatholysis, analgesia, and a low risk of apnea. These properties suggest that dexmedetomidine may be useful in procedural sedation. In view of this, we conducted a pilot trial to determine the feasibility of using dexmedetomidine as a sole agent for providing sedation during awake diagnostic flexible bronchoscopy. Patients presenting for awake diagnostic flexible bronchoscopy consented to participate in a trial of dexmedetomidine sedation for the procedure. In addition to local anesthetic topicalization of the airways, dexmedetomidine was infused at 0.5 μg/kg over 10 minutes followed by an infusion of 0.2 to 0.7 μg/kg/h titrating to a Ramsay Sedation Scale score of 3. Hemodynamic parameters (heart rate, blood pressure), oxygenation status (pulse oximetry), adverse events, use of rescue sedation, and patient and proceduralist satisfaction were recorded during the trial. Five of 9 recruited patients required rescue sedation to allow the procedure to proceed. Dexmedetomidine as a sole agent at an infusion of 0.5 μg/kg over 10 minutes followed by an infusion of 0.2 to 0.7 μg/kg/h is unable to provide adequate sedation for awake diagnostic flexible bronchoscopy without the need for rescue sedation in a large proportion of patients.

  9. Spinal posture and pelvic position during pregnancy: a prospective rasterstereographic pilot study.

    Science.gov (United States)

    Betsch, Marcel; Wehrle, Regina; Dor, Larissa; Rapp, Walter; Jungbluth, Pascal; Hakimi, Mohssen; Wild, Michael

    2015-06-01

    Despite the high prevalence of low back pain during pregnancy there is still a lack in the understanding of its aetiology. Changes of the spinal posture due to the anatomical changes of the pregnant body seem to be in part responsible for the back pain. In this pilot study we assessed the potential to accurately measure the spinal posture and pelvic position during pregnancy without any harmful radiation using a spine and surface topography system. Thirteen pregnant women were examined during the second and third trimester of their pregnancy, and postpartum. Twenty female, non-pregnant volunteers comprised the control group. The spinal posture and pelvic position were measured with a radiation-free spine and surface topography system. We found a significant increase in thoracic kyphosis during the course of pregnancy, but no increased lumbar lordosis. The lateral deviation of the spine also decreased significantly. However, we did not measure significant changes of the pelvic position during or after pregnancy. The results of our study show that pregnancy has an effect on the spinal posture, and that spine and surface topography can be used to measure these changes three-dimensionally and without any harmful radiation. In future studies this technique could allow to further evaluate the relationship between posture and low back pain during pregnancy, helping to understand the aetiology of low back pain in pregnancy as well as to identify methods for its prevention and treatment.

  10. Ketogenic diet also benefits Dravet syndrome patients receiving stiripentol: a prospective pilot study.

    Science.gov (United States)

    Nabbout, Rima; Copioli, Cristiana; Chipaux, Mathilde; Chemaly, Nicole; Desguerre, Isabelle; Dulac, Olivier; Chiron, Catherine

    2011-07-01

    We aimed to test the efficacy of ketogenic diet (KD) in patients with Dravet syndrome (DS) not satisfactorily controlled by antiepileptic drugs (AEDs). We included prospectively 15 DS patients aged >3 years with partial response to AEDs including stiripentol. All patients had a seizure diary and clinical examination with Conners and Achenbach scales before KD, at 1 month following onset and every 3 months thereafter. At 1 month, 10 patients (66%) had a decrease of seizure frequency ≥75%. Efficacy was maintained in eight responders at 3 and 6 months and in six responders at 9 months. Five patients (33%) remained on KD over 12 months, and one was seizure-free. In addition to efficacy on seizure frequency, KD was beneficial on behavior disturbances including hyperactivity. This effect was reported in all responders and in a few nonresponders. KD might have a double effect, on seizure control and on hyperactivity and behavior disturbances in patients with DS.

  11. Trajectories of abstinence-induced Internet gaming withdrawal symptoms: A prospective pilot study

    Directory of Open Access Journals (Sweden)

    Dean Kaptsis

    2016-12-01

    Full Text Available Internet Gaming Disorder (IGD is positioned in the appendix of the DSM-5 as a condition requiring further study. The IGD criteria refer to withdrawal symptoms, including irritability, anxiety, or sadness, that follow cessation of Internet gaming (APA, 2013. The aim of this study was to prospectively examine the nature of Internet gaming withdrawal symptoms, if they occur, under gaming abstinence conditions. This study employed a repeated-measures protocol to examine the cognitive-affective reactions of participants undertaking an 84-h Internet gaming abstinence period. The sample included individuals who met the IGD criteria as well as those who regularly played Internet games but did not meet the IGD criteria. Outcome variables included affect (positive and negative, psychological distress (depression, anxiety, stress, and Internet gaming withdrawal symptoms (craving/urge, thoughts about gaming, inability to resist gaming. A total of 24 participants (Mage = 24.6 years, SD = 5.8 were recruited from online gaming communities, and completed a series of online surveys before, during, and after abstaining from Massively Multiplayer Online (MMO games. Both the IGD group and the non-IGD group experienced an abstinence-induced decline in withdrawal symptomatology, negative affect, and psychological distress. The IGD group experienced its largest decline in withdrawal symptomatology within the first 24 h of abstinence. These preliminary data suggest that gaming withdrawal symptoms may follow, at least initially, negative linear and quadratic trends. Further prospective work in larger samples involving longer periods of abstinence is required to verify and expand upon these observations.

  12. Involving Software Engineering Students in Open Source Software Projects: Experiences from a Pilot Study

    Science.gov (United States)

    Sowe, Sulayman K.; Stamelos, Ioannis G.

    2007-01-01

    Anecdotal and research evidences show that the Free and Open Source Software (F/OSS) development model has produced a paradigm shift in the way we develop, support, and distribute software. This shift is not only redefining the software industry but also the way we teach and learn in our software engineering (SE) courses. But for many universities…

  13. Alemtuzumab and sirolimus in renal transplantation: six-year results of a single-arm prospective pilot study.

    Science.gov (United States)

    Sutherland, A I; Akhtar, M Z; Zilvetti, M; Brockmann, J; Ruse, S; Fuggle, S V; Sinha, S; Harden, P; Friend, P J

    2014-03-01

    mTOR inhibitors avoid calcineurin nephrotoxicity, but sirolimus de novo is associated with unacceptable side effects and higher rejection rates. We have investigated a modified strategy: alemtuzumab induction with tacrolimus and mycophenolate maintenance, switching from tacrolimus to sirolimus at 6 months and stopping mycophenolate at 12 months. Here, we report the 6-year follow-up of 30 patients prospectively recruited to this single-arm pilot study and compare outcomes to a matched contemporaneous control group of 30 patients who received standard induction and calcineurin-inhibitor-based immunosuppression.Six-year patient and graft survival were 83% and 80%(alemtuzumab) versus 77% and 70% (control). Rejection rates in the first 6 months were similar in alemtuzumab (6.6%) and control groups (10%). A higher than expected incidence of rejection in the alemtuzumab group following cessation of mycophenolate at 1 year (17%) was mitigated in later patients by retaining low dose mycophenolate. Mean eGFR was higher in the alemtuzumab group at all time points but not significantly (p¼0.16). Tacrolimus levels in the first 6 months were significantly higher in the contemporaneous control group (pAlemtuzumab induction with initial treatment with tacrolimus enables conversion to sirolimus without the side effects and incidence of acute rejection seen in earlier protocols.

  14. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

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    Elena Ricart; Maria Esteve; Montserrat Andreu; Francesc Casellas; David Monfort; Miquel Sans; Natalia Oudovenko; Raúl Lafuente; Julián Panés

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis.METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and L1 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases.Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported.CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.

  15. Prospective pilot study on the incidence of infections caused by peripheral venous catheters at a general surgical ward

    Directory of Open Access Journals (Sweden)

    Heinrich, Ines

    2013-04-01

    Full Text Available [english] Device-associated infections comprise a significant proportion of all nosocomial infections. In this prospective, observational pilot study the incidence of infections in 89 peripheral venous catheters (PVCs was documented on a general surgical ward employing an infection data sheet developed by the Institute of Hygiene and Environmental Medicine, Greifswald in adherence to CDC standards for infections. 16 of 20 infections were documented during a four-week time period when medical students in the first four months of their practical year performed their compulsory rotation on the general surgical ward. Insufficient knowledge of adequate hygienic measures as well as non-compliance to aseptical procedural measures prior to and following insertion of a peripheral venous catheter are the assumed instigators of these infections. In order to ensure a uniform hygienic standard in the performance of applied procedures, it is essential that medical students during this practical year receive not only theoretical, but also hands-on schooling prior to initiation of their subsequent official residency.

  16. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study.

    Science.gov (United States)

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy.

  17. The infiltration of the AC joint performed by one specialist: Ultrasound versus palpation a prospective randomized pilot study

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    Sabeti-Aschraf, M., E-mail: manuel.sabeti-aschraf@meduniwien.ac.a [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Ochsner, A. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schueller-Weidekamm, C. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Schmidt, M. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Funovics, Ph.T. [Vienna Medical School, Department for Radiology, AKH-Wien, Waehringer Guertel 18-20, 1090 Vienna (Austria); Skrbensky, G. von [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Goll, A. [Vienna Medical School, Core Unit for Medical Statistics and Wien, Waehringer Guertel18-20, 1090 Vienna (Austria); Schatz, K.D. [Vienna Medical School, Department for Orthopaedics and Orthopaedic Surgery, AKH-Wien, Waehringer Guertel18-20, 1090 Vienna (Austria)

    2010-07-15

    Introduction: The acromio-clavicular (AC) joint is very susceptible to degenerative processes that result in pain and functional impairment. One common modality of treatment has been local infiltration of the joint space. Although this procedure has produced notable positive results, needle misplacement occurs frequently. The aim of this investigation is to evaluate the effects of an intra articular infiltration by comparing precise needle placement into the joint space using high-resolution-ultrasound with the conventional palpation technique. Methods: This prospective and randomized pilot study analysed 20 patients who were assigned either to the 'ultrasound' or the 'palpation' group. Clinical examinations were performed before treatment and at 1 h, 1 week and 3 weeks after a single infiltration of local anaesthetic and corticoid carried out by one specialist. Results: In both groups significant improvement in pain and function was obtained up to one-week post injection. Function remained significantly improved until the last follow-up and did not differ between the two groups. The agent was administered in all patients into the joint space in the ultrasound group. Conclusion: Ultrasound guided infiltration of the AC joint is an easily achieved procedure without any complications. However, clinical follow-up did not differ between free-hand and ultrasound-guided AC joint space infiltration.

  18. Awareness of "predatory" open-access journals among prospective veterinary and medical authors attending scientific writing workshops

    Directory of Open Access Journals (Sweden)

    Mary M Christopher

    2015-08-01

    Full Text Available Authors face many choices when selecting a journal for publication. Prospective authors, especially trainees, may be unaware of predatory online journals or how to differentiate them from legitimate journals. In this study we assessed awareness of open-access and predatory journals among prospective authors attending scientific writing workshops; our long-term goal was to inform educational goals for the workshops. We surveyed participants of writing workshops at veterinary and medical schools and an international conference over a 1-year period. The survey included 14 statements for respondents to indicate agreement level on a Likert-like scale and four questions on awareness of resources about predatory journals; respondents also defined predatory journal. A total of 145 participants completed the survey: 106 (73.1% from veterinary schools and 86 (59.3% graduate students or residents. Fewer faculty (vs trainees agreed that open access was an important factor in deciding where to publish; faculty and postdoctoral researchers were more likely to expect to pay more to publish in an open-access journal. Most respondents (120/145, 82.7% agreed/strongly agreed that the decision to accept a manuscript should not be influenced by publication charges, but 50% (56/112 indicated they didn’t know how publishing costs were supported. Of the 142 respondents who answered, 33 (23.0% indicated awareness of the term predatory journal; 34 (23.9% were aware of the Directory of Open Access Journals; 24 (16.9% were aware of the Science sting article about predatory journals; and 7 (4.8% were aware of Beall’s list. Most (93/144, 64.5% definitions of predatory journals described poor but not predatory journal practices, and some respondents misunderstood the term completely. Mentors should help novice authors to be aware of predatory journals and to distinguish between legitimate and illegitimate open-access journals, thus selecting the best journal for their

  19. Awareness of "Predatory" Open-Access Journals among Prospective Veterinary and Medical Authors Attending Scientific Writing Workshops.

    Science.gov (United States)

    Christopher, Mary M; Young, Karen M

    2015-01-01

    Authors face many choices when selecting a journal for publication. Prospective authors, especially trainees, may be unaware of "predatory" online journals or how to differentiate them from legitimate journals. In this study, we assessed awareness of open-access and predatory journals among prospective authors attending scientific writing workshops; our long-term goal was to inform educational goals for the workshops. We surveyed participants of writing workshops at veterinary and medical schools and an international conference over a 1-year period. The survey included 14 statements for respondents to indicate agreement level on a Likert-like scale and four questions on awareness of resources about predatory journals; respondents also defined "predatory journal." A total of 145 participants completed the survey: 106 (73.1%) from veterinary schools and 86 (59.3%) graduate students or residents. Fewer faculty (vs trainees) agreed that open access was an important factor in deciding where to publish; faculty and postdoctoral researchers were more likely to expect to pay more to publish in an open-access journal. Most respondents (120/145, 82.7%) agreed/strongly agreed that the decision to accept a manuscript should not be influenced by publication charges, but 50% (56/112) indicated that they "didn't know" how publishing costs were supported. Of the 142 respondents who answered, 33 (23.0%) indicated awareness of the term "predatory journal"; 34 (23.9%) were aware of the Directory of Open Access Journals; 24 (16.9%) were aware of the Science "sting" article about predatory journals; and 7 (4.8%) were aware of Beall's list. Most (93/144, 64.5%) definitions of predatory journals described poor but not predatory journal practices, and some respondents misunderstood the term completely. Mentors should help novice authors to be aware of predatory journals and to distinguish between legitimate and illegitimate open-access journals, thus selecting the best journal for their

  20. Nitrous oxide-oxygen mixture during care of bedsores and painful ulcers in the elderly: a randomized, crossover, open-label pilot study.

    Science.gov (United States)

    Paris, Adeline; Horvath, Rémi; Basset, Pierre; Thiery, Stéphane; Couturier, Pascal; Franco, Alain; Bosson, Jean-Luc

    2008-02-01

    Bedsore and ulcer care can often be painful and no standardized analgesic method exists today for pain relief during treatment in adults and the elderly. To evaluate the analgesic efficacy of a nitrous oxide-oxygen mixture vs. morphine during painful bedsore and ulcer care in adult and elderly patients, we conducted a randomized, crossover, multicenter, prospective, open-label, pilot study. Thirty-four inpatients, aged 53-96 years (median 84 years), were recruited in Grenoble University Hospital, Annecy Hospital and Chambéry Hospital, France, from January to June 2001. Each of the 34 patients received morphine (M), nitrous oxide-oxygen mixture (E), or morphine+nitrous oxide-oxygen mixture (ME) during painful care in a crossover protocol. Treatments were changed every two days and the study duration was six days. Analgesia was evaluated before and after each care session using a behavioral scale to evaluate pain in noncommunicating adults (ECPA), a visual analog scale (VAS), a global hetero-evaluation scale (GHES), and the DOLOPLUS-2 scale. There was a significant overall difference (P<0.01) among the three treatments. On the ECPA, the average difference after and before care was +5.2+/-8.6 (M), -0.3+/-8 (E), and -0.6+/-7.4 (ME), respectively. There was a significant difference between M and E, and M and ME (each P<0.01). No difference was found between E and ME (P=0.97). There were similar significant differences in the GHES and DOLOPLUS-2 scales (all tests P<0.01). Post hoc comparisons showed a significant difference (P<0.01) between M and E, and between M and ME without any additional effect for M+E. No differences were found with regard to safety or tolerability. This pilot study demonstrates the superiority of nitrous oxide-oxygen mixture over morphine for analgesia. This experience suggests that this mixture has ease of use, rapid effect, and limited contraindications when used during painful bedsore and ulcer care in elderly patients. Furthermore, it is well

  1. Reduction of tinnitus severity by the centrally acting muscle relaxant cyclobenzaprine: an open-label pilot study.

    Science.gov (United States)

    Coelho, Claudia; Figueiredo, Ricardo; Frank, Elmar; Burger, Julia; Schecklmann, Martin; Landgrebe, Michael; Langguth, Berthold; Elgoyhen, Ana Belen

    2012-01-01

    Tinnitus, the phantom perception of sounds, is a highly prevalent disorder. Although a wide variety of drugs have been investigated off label for the treatment of tinnitus, there is no approved pharmacotherapy. We report an open-label exploratory pilot study to assess the effect of muscle relaxants acting on the central nervous system on tinnitus patients. Cyclobenzaprine at high (30 mg) and low doses (10 mg), orphenadrine (100 mg), tizanidine (24 mg) and eperisone (50 mg) were administered to a maximum of 20 patients per group over a 12-week period. High-dose cyclobenzaprine resulted in a significant reduction in the Tinnitus Handicap Inventory (THI) score between baseline and week 12 in the intention-to-treat sample. On the other hand, other treatments were not effective. These results were confirmed in an explorative analysis where baseline corrected THI and Clinical Global Impression scores at week 12 were compared between groups. The present open trial presents a new promising pharmacotherapy for tinnitus that should be validated in placebo-controlled double-blind trials.

  2. A Prospective Comparative Study of Arthroscopic Versus Mini-Open Latarjet Procedure With a Minimum 2-Year Follow-up.

    Science.gov (United States)

    Marion, Blandine; Klouche, Shahnaz; Deranlot, Julien; Bauer, Thomas; Nourissat, Geoffroy; Hardy, Philippe

    2017-02-01

    To compare postoperative pain during the first postoperative week and the position of the coracoid bone block at the anterior aspect of the glenoid after the arthroscopic and the mini-open Latarjet procedure. The secondary purpose was to assess functional results and recurrence after at least 2 years of follow-up. This comparative prospective study included patients who underwent a Latarjet-Bristow procedure for anterior shoulder instability in 2012. The Latarjet procedure was performed by a mini-open approach (G1) in one center and by an arthroscopic approach (G2) in the other. The main evaluation criterion was average shoulder pain during the first postoperative week assessed by the patient on a standard 10-cm visual analog scale (0-10). Secondary criteria were consumption of analgesics during the first week, the position of the coracoid bone block on radiograph and computed tomography scan at the 3-month follow-up and clinical outcomes (Western Ontario Score Index and new surgery) after at least 2 years of follow-up. Fifty-eight patients were included, 22 G1 and 36 G2, 13 women and 45 men, mean age 26.9 ± 7.7 years. The mean follow-up was 29.8 ± 4.4 months. There was significantly less pain in the arthroscopic Latarjet group than in the mini-open group during the first postoperative week (2.5 ± 1.4 vs 1.2 ± 1.2, P = .002) with comparable consumption of analgesics (P > .05). The arthroscopic Latarjet procedure resulted in a more lateral coracoid bone block (P = .04) and a better equatorial position than the mini-open technique (P = .02). Three patients underwent revision surgery (1 recurrence [2.8%], 1 block fracture, 1 screw ablation) in the arthroscopic group, none in the mini-open group (P = .54). At the final follow-up, the Western Ontario Score Index score was good in all patients (G1: 78.5 ± 7.5% vs G2: 82.3 ± 7%, P = .03). This prospective comparative study showed that the arthroscopic Latarjet procedure was significantly less painful than

  3. Daily subcutaneous parecoxib injection for cancer pain: an open label pilot study.

    Science.gov (United States)

    Kenner, David J; Bhagat, Sandeep; Fullerton, Sonia L

    2015-04-01

    Nonsteroidal anti-inflammatory analgesics (NSAIDs) are useful in cancer pain but the specific use of subcutaneous parecoxib has not been previously reported. This pilot study aimed to establish the efficacy and side effect profile of short-term sequential single daily dose subcutaneous parecoxib sodium in patients with severe cancer bone pain. Nineteen hospitalized patients with advanced cancer and uncontrolled malignant bone pain (9 males, 10 females) received 24 courses of one, two, or three days sequential therapy with 'off-label' daily subcutaneous parecoxib. All patients were receiving opioid therapy; the median baseline daily oral equivalent dose (OED) of morphine was 180 mg. Pain was assessed at baseline, 24 hours, 48 hours, and 72 hours. Pain scores as assessed on an 11-point numeric pain rating scale (NPRS), any side effects including subcutaneous site reactions, as well as patient satisfaction rating with analgesia were recorded. A clinically significant decrease in pain scores was defined as a reduction of two or more points on the NPRS. Median pain score of all patient treatments decreased from 7 to 4.5 at 24 hours (pSubcutaneous site reactions occurred in 2 (8%) treatments and were mild and self limiting. Short-term daily subcutaneous parecoxib injection was effective for malignant bone pain when added to existing analgesic therapy and was well tolerated. Further research is warranted into the short-term use of parecoxib in hospitalized patients with intractable malignant bone pain.

  4. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium.

    Science.gov (United States)

    Evans, Joanna L; Nadler, Jacob W; Preud'homme, Xavier A; Fang, Eric; Daughtry, Rommie L; Chapman, Joseph B; Attarian, David; Wellman, Samuel; Krystal, Andrew D

    2017-08-01

    Delirium is a common post-operative complication associated with significant costs, morbidity, and mortality. We sought sleep/EEG predictors of delirium present prior to delirium symptoms to facilitate developing and targeting therapies. Continuous EEG data were obtained in 12 patients post-orthopedic surgery from the day of surgery until delirium assessment on post-operative day 2 (POD2). Diminished total sleep time (r=-0.68; pdelirium severity. Patients experiencing delirium slept 2.4h less and took 2h longer to fall asleep. Greater waking EEG delta power (r=0.84; pdelirium severity. Loss of sleep on night1 post-surgery is an early predictor of subsequent delirium. EEG Delta Power alterations in waking and sleep appear to be later indicators of impending delirium. Further work is needed to evaluate reproducibility/generalizability and assess whether sleep loss contributes to causing delirium. This first study to prospectively collect continuous EEG data for an extended period prior to delirium onset identified EEG-derived indices that predict subsequent delirium that could aid in developing and targeting therapies. Copyright © 2017. Published by Elsevier B.V.

  5. Laboratory tests to identify patients at risk of early major adverse events: a prospective pilot study.

    Science.gov (United States)

    Kaufman, M; Bebee, B; Bailey, J; Robbins, R; Hart, G K; Bellomo, R

    2014-10-01

    To test whether commonly measured laboratory variables can identify surgical patients at risk of major adverse events (death, unplanned intensive care unit (ICU) admission or rapid response team (RRT) activation). We conducted a prospective observational study in a surgical ward of a university-affiliated hospital in a cohort of 834 surgical patients admitted for >24 h. We applied a previously validated multivariable model-derived risk assessment to each combined set of common laboratory tests to identify patients at risk. We compared the clinical course of such patients with that of control patients from the same ward who had blood tests but were identified as low risk. We studied 7955 batches and 73,428 individual tests in 834 patients (males 55%; average age 65.8 ± 17.6 years). Among these patients, 66 (7.9%) were identified as 'high risk'. High-risk patients were older (75.9 vs 61.8 years of age; P identify surgical ward patients at risk of early major adverse events. Further studies are needed to assess whether such identification system can be used to trigger interventions that help improve patient outcomes. © 2014 The Authors; Internal Medicine Journal © 2014 Royal Australasian College of Physicians.

  6. Physiotherapy Post Lumbar Discectomy: Prospective Feasibility and Pilot Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Alison Rushton

    Full Text Available To evaluate: acceptability and feasibility of trial procedures; distribution of scores on the Roland Morris Disability Questionnaire (RMDQ, planned primary outcome; and efficient working of trial components.A feasibility and external pilot randomised controlled trial (ISRCTN33808269, assigned 10/12/2012 was conducted across 2 UK secondary care outpatient physiotherapy departments associated with regional spinal surgery centres.Consecutive consenting patients aged >18 years; post primary, single level, lumbar discectomy.Participants were randomised to either 1:1 physiotherapy outpatient management including patient leaflet, or patient leaflet alone.Blinded assessments were made at 4 weeks post surgery (baseline and 12 weeks post baseline (proposed primary end point. Secondary outcomes included: Global Perceived Effect, back/leg pain, straight leg raise, return to work/function, quality of life, fear avoidance, range of movement, medication, re-operation.At discharge, 110 (44% eligible patients gave consent to be contacted. 59 (54% patients were recruited. Loss to follow up was 39% at 12 weeks, with one site contributing 83% losses. Mean (SD RMDQ was 10.07 (5.58 leaflet and 10.52 (5.94 physiotherapy/leaflet at baseline; and 5.37 (4.91 leaflet and 5.53 (4.49 physiotherapy/leaflet at 12 weeks. 5.1% zero scores at 12 weeks illustrated no floor effect. Sensitivity to change was assessed at 12 weeks with mean (SD change -4.53 (6.41, 95%CI -7.61 to -1.44 for leaflet; and -6.18 (5.59, 95%CI -9.01 to -3.30 for physiotherapy/leaflet. RMDQ mean difference (95%CI between change from baseline to twelve weeks was 1.65(-2.46 to 5.75. Mean difference (95%CI between groups at 12 weeks was -0.16 (-3.36 to 3.04. Participant adherence with treatment was good. No adverse events were reported.Both interventions were acceptable, and it is promising that they both demonstrated a trend in reducing disability in this population. A randomised controlled trial, using a

  7. 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 Epilepsy.

  8. Effects of quetiapine and olanzapine in patients with psychosis and violent behavior: a pilot randomized, open-label, comparative study

    Directory of Open Access Journals (Sweden)

    Gobbi G

    2014-05-01

    Full Text Available Gabriella Gobbi,1,2 Stefano Comai,1 Guy Debonnel1,2,† 1Neurobiological Psychiatric Unit, Department of Psychiatry, McGill University and McGill University Health Center, 2Institut Philippe Pinel, Department of Psychiatry, Université de Montréal, Montréal, QC, Canada †Guy Debonnel passed away on November 4, 2006 Objective: Patients suffering from psychosis are more likely than the general population to commit aggressive acts, but the therapeutics of aggressive behavior are still a matter of debate. Methods: This pilot randomized, open-label study compared the efficacy of quetiapine versus olanzapine in reducing impulsive and aggressive behaviors (primary endpoints and psychotic symptoms (secondary endpoints from baseline to days 1, 7, 14, 28, 42, 56, and 70, in 15 violent schizophrenic patients hospitalized in a maximum-security psychiatric hospital. Results: Quetiapine (525±45 mg and olanzapine (18.5±4.8 mg were both efficacious in reducing Impulsivity Rating Scale from baseline to day 70. In addition, both treatments reduced the Brief Psychiatric Rating Scale, Positive and Negative Syndrome Scale, and Clinical Global Impression Scale scores at day 70 compared to baseline, and no differences were observed between treatments. Moreover, quetiapine, but not olanzapine, yielded an improvement of depressive symptoms in the items “depression” in Brief Psychiatric Rating Scale and “blunted affect” in Positive and Negative Syndrome Scale. Modified Overt Aggression Scale scores were also decreased from baseline to the endpoint, but due to the limited number of patients, it was not possible to detect a significant difference. Conclusion: In this pilot study, quetiapine and olanzapine equally decreased impulsive and psychotic symptoms after 8 weeks of treatment. Double-blind, large studies are needed to confirm the validity of these two treatments in highly aggressive and violent schizophrenic patients. Keywords: schizophrenia, aggression

  9. Aquatic therapy versus conventional land-based therapy for Parkinson's disease: an open-label pilot study.

    Science.gov (United States)

    Vivas, Jamile; Arias, Pablo; Cudeiro, Javier

    2011-08-01

    To assess and compare 2 different protocols of physiotherapy (land or water therapy) for people with Parkinson's disease (PD) focused on postural stability and self-movement, and to provide methodological information regarding progression within the program for a future larger trial. Randomized, controlled, open-label pilot trial. Outpatients, Parkinson's disease Center of Ferrol-Galicia (Spain). Individuals (N=11) with idiopathic PD in stages 2 or 3 according to the Hoehn and Yahr Scale completed the investigation (intervention period plus follow-up). After baseline evaluations, participants were randomly assigned to a land-based therapy (active control group) or a water-based therapy (experimental group). Participants underwent individual sessions for 4 weeks, twice a week, for 45 minutes per session. Both interventions were matched in terms of exercise features, which were structured in stages with clear objectives and progression criteria to pass to the next phase. Participants underwent a first baseline assessment, a posttest immediately after 4 weeks of intervention, and a follow-up assessment after 17 days. Evaluations were performed OFF-dose after withholding medication for 12 hours. Functional assessments included the Functional Reach Test (FRT), the Berg Balance Scale (BBS), the UPDRS, the 5-m walk test, and the Timed Up and Go test. A main effect of both therapies was seen for the FRT. Only the aquatic therapy group improved in the BBS and the UPDRS. In this pilot study, physiotherapy protocols produced improvement in postural stability in PD that was significantly larger after aquatic therapy. The intervention protocols are shown to be feasible and seem to be of value in amelioration of postural stability-related impairments in PD. Some of the methodological aspects detailed here can be used to design larger controlled trials. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  10. A prospective single centre pilot evaluation of a serum calprotectin assay in unselected GI patients.

    Science.gov (United States)

    McCann, Rebecca K; Smith, Karen; Gaya, Daniel R

    2017-06-01

    Whilst C-reactive protein (CRP) is an established serum marker of inflammation, its use in gastroenterology has been limited by its poor sensitivity and specificity for GI disease. Faecal calprotectin (FC) has been adopted into mainstream GI practice as a sensitive but non-specific marker of intestinal inflammation. However, stool samples collection for FC can be challenging and the possibility of utilising a sensitive and specific serum biomarker of intestinal inflammation in luminal gastroenterology is an attractive prospect. This work investigates the performance of serum calprotectin (SC) compared to current biomarkers, FC and CRP, in an unselected cohort of patients attending our GI unit. Patients attending in and outpatients within an adult GI service who submitted a stool sample for FC analysis were identified. A total of 109 who had a serum sample obtained within one day of stool sample collection had the serum analysed for CRP and SC and the correlation between these biomarkers was investigated. The intraclass correlation coefficient (ICC) between SC, FC and CRP was 0.10, 95% CI -0.09-0.28 and 0.18, 95% CI -0.01-0.35, respectively. The ICC between FC and CRP was 0.18, 95% CI -0.01-0.35. Our data reveals that there is no significant correlation between SC and FC, nor between SC and CRP in a large unselected cohort of GI patients. Therefore, as a serum biomarker for intestinal inflammation, SC is unlikely to be of clinical utility and the search for an appropriate serum GI biomarker continues. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  11. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  12. Clinical outcomes and risk factors for perforation in gastric endoscopic submucosal dissection: A prospective pilot study.

    Science.gov (United States)

    Watari, Jiro; Tomita, Toshihiko; Toyoshima, Fumihiko; Sakurai, Jun; Kondo, Takashi; Asano, Haruki; Yamasaki, Takahisa; Okugawa, Takuya; Ikehara, Hisatomo; Oshima, Tadayuki; Fukui, Hirokazu; Miwa, Hiroto

    2013-06-16

    To evaluate clinical outcomes and risk factors for endoscopic perforation during endoscopic submucosal dissection (ESD) in a prospective study. We investigated the clinical outcomes and risk factors for the development of perforation in 98 consecutive gastric neoplasms undergoing ESD regarding. Demographic and clinical parameters including patient-, tumor-, and treatment-related factors, clinical parameters, and duration of hospital stay were analyzed for risk factors for perforation. In subgroup analysis, we also compared the clinical outcomes between perforation and "silent" free air without endoscopically visible perforation detected only by computed tomography. Perforation was identified in 8.2% of patients. All patients were managed conservatively by the administration of antibiotics. The mean procedure time was significantly longer in patients with endoscopic perforation than in those without. According to the receiver-operating characteristic analysis, the resulting cutoff value of the procedure time for perforation was 115 min (87.5% sensitivity, 56.7% specificity). Prolonged procedure time (≥ 115 min) was associated with an increased risk of perforation (odds ratio 9.15; 95%CI: 1.08-77.54; P = 0.04). Following ESD, body temperature and C-reactive protein level were significantly higher in patients with perforation than in those without (P = 0.02), whereas there was no difference between these patient groups on the starting day of oral intake or of hospitalization. In subgroup analysis, the post-ESD clinical course was not different between endoscopic perforation and silent free air. Only prolonged procedure time (≥ 115 min) was significantly associated with perforation. The clinical outcomes of perforation are favorable and are comparable to those of patients with or without silent free air.

  13. The prediction of difficult intubation in obese patients using mirror indirect laryngoscopy: A prospective pilot study

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    Arne O Budde

    2013-01-01

    Full Text Available Background: The incidence of difficult laryngoscopy and intubation in obese patients is higher than in the general population. Classical predictors of difficult laryngoscopy and intubation have been shown to be unreliable. We prospectively evaluated indirect mirror laryngoscopy as a predictor of difficult laryngoscopy in obese patients. Materials and Methods: 60 patients with a body mass index (BMI greater than 30, scheduled to undergo general anesthesia, were enrolled. Indirect mirror laryngoscopy was performed and was graded 1-4 according to Cormack and Lehane. A view of grade 3-4 was classified as predicting difficult laryngoscopy. Additional assessments for comparison were the Samsoon and Young modification of the Mallampati airway classification, Wilson Risk Sum Score, neck circumference, and BMI. The view obtained upon direct laryngoscopy after induction of general anesthesia was classified according to Cormack and Lehane as grade 1-4. Results: Sixty patients met the inclusion criteria; however, 8 (13.3% patients had an excessive gag reflex, and examination of the larynx was not possible. 15.4% of patients who underwent direct laryngoscopy had a Cormack and Lehane grade 3 or 4 view and were classified as difficult. Mirror laryngoscopy had a tendency toward statistical significance in predicting difficult laryngoscopy in these patients. Conclusions: This study is consistent with previous studies, which have demonstrated that no one individual traditional test has proven to be adequate in predicting difficult airways in the obese population. However, the new application of an old test - indirect mirror laryngoscopy - could be a useful additional test to predict difficult laryngoscopy in obese patients.

  14. Prospective pilot study of CT-guided microwave ablation in the treatment of osteoid osteomas

    Energy Technology Data Exchange (ETDEWEB)

    Prud' homme, Clara; Nueffer, Jean-Philippe; Runge, Michel; Dubut, Jonathan [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); Kastler, Bruno [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); I4S Laboratory, INSERM EA4268, University of Franche-Comte, Besancon (France); Aubry, Sebastien [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); Nanomedecine Laboratory, INSERM EA4662, University of Franche-Comte, Besancon (France)

    2017-03-15

    The aims of this work were to assess the feasibility and efficacy of CT-guided microwave ablation (MWA) in the treatment of osteoid osteomas (OOs). Thirteen consecutive patients (range 11-31 years old) presenting with OO were prospectively included and treated by CT-guided MWA. Power and duration of MWA were both recorded. The patient's pain was assessed using a numeric pain rating scale (NRS), and side effects were recorded during procedures, after 1 day, 7 days and 1 month. The nidus vascularization and the volume of necrosis induced by MWA were assessed using contrast-enhanced MRI. Success was defined as the complete relief of the patient's pain 1 month after the first procedure, associated with necrosis of the nidus on follow-up MRI. The success rate was up to 92.3% (12/13). At 1 day, 7 days and 1 month, the median NRSs were respectively 5 [interquartile range (IQR) 2-5], 0 (IQR 0-1) and 0 (IQR 0-0). Side effects observed were one partial and self-resolving lesion of a sensory branch of the radial nerve and two skin burns. The median power of the MWA used was 60 W (IQR 50-60) with a 1.5-min duration (IQR 1-2), leading to MWA-induced necrosis measuring on average 23 x 15 x 16 mm. CT-guided MWA of OO has a success rate that appears to be almost similar to that of laser or radiofrequency ablation, but care must be taken to prevent nerve or skin lesions. (orig.)

  15. Monitoring Central Venous Catheter Resistance to Predict Imminent Occlusion: A Prospective Pilot Study.

    Science.gov (United States)

    Wolf, Joshua; Tang, Li; Rubnitz, Jeffrey E; Brennan, Rachel C; Shook, David R; Stokes, Dennis C; Monagle, Paul; Curtis, Nigel; Worth, Leon J; Allison, Kim; Sun, Yilun; Flynn, Patricia M

    2015-01-01

    Long-term central venous catheters are essential for the management of chronic medical conditions, including childhood cancer. Catheter occlusion is associated with an increased risk of subsequent complications, including bloodstream infection, venous thrombosis, and catheter fracture. Therefore, predicting and pre-emptively treating occlusions should prevent complications, but no method for predicting such occlusions has been developed. We conducted a prospective trial to determine the feasibility, acceptability, and efficacy of catheter-resistance monitoring, a novel approach to predicting central venous catheter occlusion in pediatric patients. Participants who had tunneled catheters and were receiving treatment for cancer or undergoing hematopoietic stem cell transplantation underwent weekly catheter-resistance monitoring for up to 12 weeks. Resistance was assessed by measuring the inline pressure at multiple flow-rates via a syringe pump system fitted with a pressure-sensing transducer. When turbulent flow through the device was evident, resistance was not estimated, and the result was noted as "non-laminar." Ten patients attended 113 catheter-resistance monitoring visits. Elevated catheter resistance (>8.8% increase) was strongly associated with the subsequent development of acute catheter occlusion within 10 days (odds ratio = 6.2; 95% confidence interval, 1.8-21.5; p change in resistance greater than 8.8% or a non-laminar result predicted subsequent occlusion (odds ratio = 6.8; 95% confidence interval, 2.0-22.8; p = 0.002; sensitivity, 80%; specificity, 63%). Participants rated catheter-resistance monitoring as highly acceptable. In this pediatric hematology and oncology population, catheter-resistance monitoring is feasible, acceptable, and predicts imminent catheter occlusion. Larger studies are required to validate these findings, assess the predictive value for other clinical outcomes, and determine the impact of pre-emptive therapy. Clinicaltrials

  16. 30-day hospital readmission of older adults using care transitions after hospitalization: a pilot prospective cohort study

    Directory of Open Access Journals (Sweden)

    Takahashi PY

    2013-06-01

    Full Text Available Paul Y Takahashi,1 Lindsey R Haas,2 Stephanie M Quigg,1 Ivana T Croghan,1 James M Naessens,2 Nilay D Shah,2 Gregory J Hanson11Division of Primary Care Internal Medicine, Department of Medicine, 2Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USAPurpose: Patients leaving the hospital are at increased risk of functional decline and hospital readmission. The Employee and Community Health service at Mayo Clinic in Rochester developed a care transition program (CTP to provide home-based care services for medically complex patients. The study objective was to determine the relationship between CTP use, 30-day hospital readmission, and Emergency Room (ER visits for adults over 60 years with high Elder Risk Assessment scores.Patients and methods: This was a pilot prospective cohort study that included 20 patients that used the CTP and 20 patients discharged from the hospital without using the CTP. The medically complex study patients were drawn from the department of Employee and Community Health population between October 14, 2011 and September 27, 2012. The primary outcomes were 30-day hospital readmission or ER visit after discharge from the hospital. The secondary outcomes were within-group changes in grip strength, gait speed, and quality of life (QOL. Patients underwent two study visits, one at baseline and one at 30 days postbaseline. The primary analysis included time-to-event from baseline to rehospitalization or ER visit. Paired t-tests were used for secondary outcomes, with continuous scores.Results: Of the 40 patients enrolled, 36 completed all study visits. The 30-day hospital readmission rates for usual care patients were 10.5% compared with no readmissions for CTP patients. There were 31.6% ER visits in the UC group and 11.8% in the CTP group (P = 0.37. The secondary analysis showed some improvement in physical QOL scores (pre: 32.7; post: 39.4 for the CTP participants (P < 0.01 and no differences in gait speed or

  17. Future prospectives of sub-Saharan women living with HIV residing in France for more than seven years: prospective pilot study

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    Svetlane Dimi

    2014-11-01

    Full Text Available Introduction: In 2011, a French national survey of people living with HIV (PLHIV has shown that 40% of persons diagnosed since 2003 are originated from sub-Saharan Africa, two thirds of them being women. For them, in the short term, access to social rights is a priority. Today, over 90% of PLHIV are treated effectively and with the aging of this population, questions about their future perspectives arise. Our service provides a multidisciplinary (medical, psychological, social approach to PLHIV. The aim of our study is to describe the future perspectives of sub-Saharan women living with HIV residing in France for more than 7 years, because it is the time required for the implementation of fundamental rights and social insertion. Do they plan to return to their country of origin after their retirement? Does the HIV infection force them to stay in France? Materials and Methods: Prospective pilot mono-centric study. Between January and April 2014, every HIV-infected woman born in a sub-Saharan country, resident in France for at least 7 years, attending for their routine outpatient visit was consecutively included. Data were collected through a structured, semi-directed interview made by their usual hospital physician or social worker. Results: Consecutively, 76 women agreed to participate to the interview, none refused. Mean age: 42 years [26–70], time since HIV diagnosis: 12 years [1–25]. HIV diagnosis was made before arriving in France for 3% of them; in 33% diagnosis was made in the year of arrival; diagnosis made several years after arrival in 63%. Even if 69% of these women had been irregularly residing in France for a period, all of them had obtained a regular situation for residence and 50% acquired the French nationality. Mean duration of residence was 15 years [7–33]. Two thirds of them are employed. In the future, although 50% plan to have a shared residence between France and Africa, only 20% of them plan to settle back definitely

  18. Anabolic steroids after total knee arthroplasty. A double blinded prospective pilot study

    Directory of Open Access Journals (Sweden)

    Hohmann Stefanie

    2010-12-01

    Full Text Available Abstract Background Total knee arthroplasty is reported to improve the patient's quality of life and mobility. However loss of mobility and pain prior to surgery often results in disuse atrophy of muscle. As a consequence the baseline functional state prior to surgery may result in poorer outcome "post surgery" and extended rehabilitation may be required. The use of anabolic steroids for performance enhancement and to influence muscle mass is well established. The positive effects of such treatment on bone and muscle could therefore be beneficial in the rehabilitation of elderly patients. The purpose of this study was to investigate the effects of small doses of Nandrolone decanoate on recovery and muscle strength after total knee replacement and to establish the safety of this drug in multimorbid patients. Methods This study was designed as a prospective double blind randomized investigation. Five patients (treatment group with a mean age of 66.2 (58-72, average BMI of 30.76 (24.3-35.3 received 50 mg nandrolone decanoate intramuscular bi-weekly for 6 months. The control group (five patients; mean age 65.2, range 59-72; average BMI 31.7, range 21.2-35.2 was injected with saline solution. "Pre-operatively" and "post-operatively" (6 weeks, 3,6,9 and 12 months all patients were assessed using the knee society score (KSS, isokinetic strength testing and functional tests (a sit-to-stand and timed walking tests. In addition, a bone density scan was used preoperatively and 6 month postoperatively to assess bone mineral density. Results Whilst the steroid group generally performed better than the placebo group for all of the functional tests, ANOVA failed to reveal any significant differences. The steroid group demonstrated higher levels of quadriceps muscle strength across the postoperative period which reached significance at 3 (p = 0.02, 6 (p = 0.01, and 12 months (p = 0.02. There was a significant difference for the KSS at 6 weeks (p = 0.02, 6 (p

  19. Early endoscopic ultrasonography in acute biliary pancreatitis: A prospective pilot study

    Science.gov (United States)

    Anderloni, Andrea; Galeazzi, Marianna; Ballarè, Marco; Pagliarulo, Michela; Orsello, Marco; Del Piano, Mario; Repici, Alessandro

    2015-01-01

    AIM: To investigate the clinical usefulness of early endoscopic ultrasonography (EUS) in the management of acute biliary pancreatitis (ABP). METHODS: All consecutive patients entering the emergency department between January 2010 and December 2012 due to acute abdominal pain and showing biochemical and/or radiological findings consistent with possible ABP were prospectively enrolled. Patients were classified as having a low, moderate, or high probability of common bile duct (CBD) stones, according to the established risk stratification. Exclusion criteria were: gastrectomy or patient in whom the cause of biliary obstruction was already identified by ultrasonography. All enrolled patients underwent EUS within 48 h of their admission. Endoscopic retrograde cholangiopancreatography was performed immediately after EUS only in those cases with proven CBD stones or sludge. The following parameters were investigated: (1) clinical: age, sex, fever; (2) radiological: dilated CBD; and (3) biochemical: bilirubin, AST, ALT, gGT, ALP, amylase, lipasis, PCR. Association between presence of CBD stone at EUS and the individual predictors were assessed by univariate logistic regression. Predictors significantly associated with CBD stones (P < 0.05) were entered in a multivariate logistic regression model. RESULTS: A total of 181 patients with pancreatitis were admitted to the emergency department between January 2010 and December 2012. After exclusion criteria a total of 71 patients (38 females, 53.5%, mean age 58 ± 20.12 years, range 27-89 years; 33 males, 46.5%, mean age 65 ± 11.86 years, range 41-91 years) were included in the present study. The probability of CBD stones was considered low in 21 cases (29%), moderate in 26 (37%), and high in the remaining 24 (34%). The 71 patients included in the study underwent EUS, which allowed for a complete evaluation of the target sites in all the cases. The procedure was completed in a mean time of 14.7 min (range 9-34 min), without

  20. Efficacy of chess training for the treatment of ADHD: A prospective, open label study.

    Science.gov (United States)

    Blasco-Fontecilla, Hilario; Gonzalez-Perez, Marisa; Garcia-Lopez, Raquel; Poza-Cano, Belen; Perez-Moreno, Maria Rosario; de Leon-Martinez, Victoria; Otero-Perez, Jose

    2016-01-01

    To examine the effectiveness of playing chess as a treatment option for children with ADHD. Parents of 44 children ages 6 to 17 with a primary diagnosis of ADHD consented to take part in the study. Parents completed the Spanish version of the Swanson, Nolan and Pelham Scale for parents (SNAP-IV) and the Abbreviated Conner's Rating Scales for parents (CPRS-HI) prior to an 11-week chess-training program. We used a paired t-test to compare pre- and post-intervention outcomes, and Cohen-d calculations to measure the magnitude of the effect. The statistical significance was set at P<.05. Children with ADHD improved in both the SNAP-IV (t=6.23; degrees of freedom (df)=41; P<.001) and the CPRS-HI (t=5.39; df=33; P<.001). Our results suggest a large effect in decreasing the severity of ADHD as measured by the SNAP-IV (d=0.85) and the CPRS-HI (d=0.85). Furthermore, we found a correlation between intelligence quotient and SNAP-IV improvement (P<.05). The results of our pilot study should be interpreted with caution. This pilot project highlights the importance of carrying out larger studies with a case-control design. If our results are replicated in better designed studies, playing chess could be included within the multimodal treatment of ADHD. Copyright © 2014 SEP y SEPB. Published by Elsevier España. All rights reserved.

  1. An open-label pilot study of quetiapine plus mirtazapine for heavy drinkers with alcohol use disorder.

    Science.gov (United States)

    Brunette, Mary F; Akerman, Sarah C; Dawson, Ree; O'Keefe, Christopher D; Green, Alan I

    2016-06-01

    Animal research suggests that medications that produce a weak dopamine D2 receptor blockade and potentiate noradrenergic activity may decrease alcohol drinking. In an open-label pilot study of subjects with alcohol dependence, we tested whether the combination of quetiapine, a weak dopamine D2 receptor antagonist, whose primary metabolite, desalkylquetiapine, is a norepinephrine reuptake inhibitor, and mirtazapine, a potent α2 norepinephrine receptor antagonist, would decrease alcohol drinking and craving. Twenty very heavy drinkers with alcohol dependence entered a trial of 8 weeks of treatment with quetiapine followed by 8 weeks of treatment with a combination of quetiapine plus mirtazapine. Alcohol use was assessed weekly with a Timeline Follow-Back interview and craving with the Penn Alcohol Craving Scale. Among the 11 completers, subjects reported improved outcomes in the quetiapine plus mirtazapine period compared to the quetiapine alone period: fewer very heavy drinking days per week (1.3 [SD = 2.4] vs. 2.1 [SD = 2.8]; t = 2.3, df = 10, p = 0.04); fewer total number of drinks per week (39.7 [SD = 61.6] vs. 53.4 [SD = 65.0]; t = 2.8, df = 10, p = 0.02); and lower craving scores (2.5 [SD = 1.4] vs. 3.2 [SD = 1.2]; t = 2.4, df = 10, p = 0.04). All subjects reported at least one adverse event; 72.7% reported somnolence. In this open-label pilot study, treatment with quetiapine plus mirtazapine was associated with a decrease in alcohol drinking and craving. These findings are consistent with our previous work in animal models of alcohol use disorders and suggest that further study of medications or combinations of medications with this pharmacologic profile is warranted.

  2. A Prospective, Longitudinal Study of US Children Unable to Achieve Open-Set Speech Recognition Five Years after Cochlear Implantation

    Science.gov (United States)

    Barnard, JM; Fisher, LM; Johnson, KC; Eisenberg, LS; Wang, NY; Quittner, AL; Carson, CM; Niparko, JK

    2015-01-01

    Objective To identify characteristics associated with inability to progress to open-set speech recognition in children who are 5 years post cochlear implantation. Study Design Prospective, longitudinal and multidimensional assessment of auditory development over 5 years. Setting Six tertiary cochlear implant (CI) referral centers in the US. Patients Children with severe-to-profound hearing loss who underwent implantation before age 5 years enrolled in the Childhood Development after Cochlear Implant (CDaCI) study, categorized by level of speech recognition ability. Intervention(s) Cochlear implantation prior to 5 years of age and annual assessment of emergent speech recognition skills. Main outcome measure(s) Progression to open-set speech recognition by 5 years after implantation. Results Less functional hearing prior to implantation, older age at onset of amplification, lower maternal sensitivity to communication needs, minority status, and complicated perinatal history were associated with inability to obtain open set speech recognition by 5 years. Conclusions Characteristics of a subpopulation of children with CIs that were associated with an inability to achieve open-set speech recognition after 5 years of CI experience were investigated. These data distinguish pediatric CI recipients at risk for poor auditory development and highlight areas for future interventions to enhance support of early implantation. PMID:25700015

  3. Open source challenges for hospital information system (HIS) in developing countries: a pilot project in Mali

    Science.gov (United States)

    2010-01-01

    Background We are currently witnessing a significant increase in use of Open Source tools in the field of health. Our study aims to research the potential of these software packages for developing countries. Our experiment was conducted at the Centre Hospitalier Mere Enfant in Mali. Methods After reviewing several Open Source tools in the field of hospital information systems, Mediboard software was chosen for our study. To ensure the completeness of Mediboard in relation to the functionality required for a hospital information system, its features were compared to those of a well-defined comprehensive record management tool set up at the University Hospital "La Timone" of Marseilles in France. It was then installed on two Linux servers: a first server for testing and validation of different modules, and a second one for the deployed full implementation. After several months of use, we have evaluated the usability aspects of the system including feedback from end-users through a questionnaire. Results Initial results showed the potential of Open Source in the field of health IT for developing countries like Mali. Five main modules have been fully implemented: patient administrative and medical records management of hospital activities, tracking of practitioners' activities, infrastructure management and the billing system. This last component of the system has been fully developed by the local Mali team. The evaluation showed that the system is broadly accepted by all the users who participated in the study. 77% of the participants found the system useful; 85% found it easy; 100% of them believe the system increases the reliability of data. The same proportion encourages the continuation of the experiment and its expansion throughout the hospital. Conclusions In light of the results, we can conclude that the objective of our study was reached. However, it is important to take into account the recommendations and the challenges discussed here to avoid several

  4. An Open, Pilot Study of the Understanding Words Reading Intervention Program

    Directory of Open Access Journals (Sweden)

    Craig Wright

    2011-09-01

    Full Text Available The aim of this study was to assess the clinical efficacy of a new reading intervention program, Understanding Words, for struggling readers in an open trial design. Twenty-five participants who had poor reading skills and typically had a mix of coexisting developmental disorders completed the 40-hr program over 20 weeks. Significant gains were achieved on measures of word identification, phonological decoding, and reading comprehension. Growth in reading ability per hour of intervention matched the average reported in the literature. Individual analysis showed that 84% of the sample returned to the average range on a measure of phonological decoding and 52% to 56% achieved the same gains in reading comprehension. Limitations of study design and future research directions are also discussed.

  5. A prospective, open-label study of low-dose total skin electron beam therapy in mycosis fungoides

    DEFF Research Database (Denmark)

    Kamstrup, Maria R; Specht, Lena; Skovgaard, Gunhild L

    2008-01-01

    PURPOSE: To determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of Stage IB-II mycosis fungoides in a prospective, open-label study. METHODS AND MATERIALS: Ten patients (6 men, 4 women, average age 68.7 years [range, 55-82 years]) with histopatholog......PURPOSE: To determine the effect of low-dose (4 Gy) total skin electron beam therapy as a second-line treatment of Stage IB-II mycosis fungoides in a prospective, open-label study. METHODS AND MATERIALS: Ten patients (6 men, 4 women, average age 68.7 years [range, 55-82 years......]) with histopathologically confirmed mycosis fungoides T2-T4 N0-N1 M0 who did not achieve complete remission or relapsed within 4 months after treatment with psoralen plus ultraviolet-A were included. Treatment consisted of low-dose total skin electron beam therapy administered at a total skin dose of 4 Gy given in 4...... causes and did not complete treatment. Acute side effects included desquamation, xerosis, and erythema of the skin. No severe side effects were observed. CONCLUSION: Low-dose total skin electron beam therapy can induce complete and partial responses in Stage IB-II mycosis fungoides; however, the duration...

  6. Supporting parents in taking care of their infants admitted to a neonatal intensive care unit: a prospective cohort pilot study.

    Science.gov (United States)

    De Bernardo, Giuseppe; Svelto, Maria; Giordano, Maurizio; Sordino, Desiree; Riccitelli, Marina

    2017-04-17

    Family-Centred Care (FCC) is recognized as an important component of all paediatric care, including neonatal care, although practical clinical guidelines to support this care model are still needed in Italy. The characteristics and services for families in Italian NICUs show a lack of organization and participation. The first aim was to compare satisfaction and stress levels in two groups of parents: an FCC group and a non-FCC group (NFCC). The second aim was to evaluate body weight gain in the newborns enrolled. This non-randomized, prospective cohort pilot study was conducted in a single level III NICU at a hospital in Naples, Italy. A cohort of newborns in the NICU, with their parents were enrolled between March 2014 and April 2015 and they were divided into two groups: the FCC group (enrolled between October 2014 and April 2015) remained in the NICU for 8 h a day with FCC model; the NFCC group (enrolled between March 2014 and September 2014) was granted access to the NICU for only 1 hour per day. At discharge, both parent groups completed the Parental Stressor Scale (PSS)-NICU and a questionnaire to assess their satisfaction. In addition, we compared scores from the mothers and fathers within and between groups and the body weights of the newborns in the two groups at 60 days. Parents participating in the FCC group were more satisfied and less stressed than those in the NFCC group. Infants in the FCC group also showed increased body weight after 60 days of hospital stay. Despite our small population, we confirm that routine adoption of a procedure designed to apply a FCC model can contribute to improving satisfaction and distress among preterm infants' parents. Future multi-centre, randomized, controlled trials are needed to confirm these findings.

  7. Association of Cardiac Development with Assisted Reproductive Technology in Childhood: A Prospective Single-Blind Pilot Study

    Directory of Open Access Journals (Sweden)

    Jie Zhou

    2014-08-01

    Full Text Available Aims: To examine the pattern and extent of cardiovascular developmental alterations among children conceived by assisted reproductive technology (ART and its association with potential confounders. Methods: The present study was a prospective single-blind pilot design lasting 15 months. The ART group was recruited by a non-random, consecutive sample on the basis of the unique personal identification number assigned to ART children, whereas spontaneous conception controls were recruited by a population-based random sample from the same hospital by age. Echocardiography was available for the measurement of 128 ART children and 100 controls with respect to cardiovascular geometric morphology and cardiac function. Results: The majority of cardiac geometric morphology parameters were comparable among the study groups (P>0.05, except for significant increases in left ventricular (LV relative wall thickness (P=0.038, LV mass index (P=0.005 and LV remodeling index (P=0.005 in ART children after adjustment for age, gender, body surface area and heart rate. The results showed similarity in LV systolic function characterized by ejection fraction (P=0.140 and shortening fraction (P=0.167 between the groups. However, ART children had a significant tendency toward a decrease in mitral A (P=0.008 and mitral E′ (P=0.012 compared with controls after adjusting for confounders. Additionally, Cox analysis suggested an independent association (PConclusion: Our findings support the presence of remodeling in the left cardiac geometric morphology and diastolic dysfunction and the absence of any change to the aortocoronary morphometry or systolic function in ART children compared with controls, which may be independently associated with the anthropometrics and perinatal outcomes in addition to the ART procedure.

  8. Postoperative functional voice changes after conventional open or robotic thyroidectomy: a prospective trial.

    Science.gov (United States)

    Lee, Jeonghun; Na, Kuk Young; Kim, Ra Mi; Oh, Yeonju; Lee, Ji Hyun; Lee, Jandee; Lee, Jin-Seok; Kim, Chul-Ho; Soh, Euy-Young; Chung, Woong Youn

    2012-09-01

    To use objective and subjective voice function analysis to compare outcomes in patients who had undergone conventional open thyroidectomy or robotic thyroidectomy. The study involved 88 consecutive patients who underwent thyroid surgery between May 2009 and December 2009; 46 patients underwent a conventional open thyroidectomy, and 42 underwent a robotic thyroidectomy. Auditory perceptual evaluation was used to make subjective assessments of voice function, and videolaryngostroboscopy, acoustic voice analysis with aerodynamic study, electroglottography, and voice range profile were used to make objective assessments. Each assessment was made before surgery, and at 1 week and 3 months after surgery. The conventional open and robotic thyroidectomy groups were similar in terms of age, gender ratio, and disease profile. We found that 18 (20.5%) of the 88 patients showed some level of voice dysfunction at 1 week after surgery; that the dysfunction resolved by 3 months after surgery in all cases; and that it was not permanent according to postoperative videolaryngostroboscopy. The conventional open and robotic thyroidectomy groups were found to have similar levels of dysfunction at 1 week after surgery, except for jitter, which was greater in the robotic group. For both groups, any such dysfunction spontaneously resolved by 3 months after surgery, and there were no significant differences between the groups in terms of any voice function parameter. Voice dysfunction was present after both open and robotic thyroidectomy (without any evident laryngeal nerve injury). However, function subsequently normalized to preoperative levels at 3 months after surgery in both groups. Voice function outcomes after robotic thyroidectomy are similar to those after conventional open thyroidectomy.

  9. Flaxseed supplementation in non-alcoholic fatty liver disease: a pilot randomized, open labeled, controlled study.

    Science.gov (United States)

    Yari, Zahra; Rahimlou, Mehran; Eslamparast, Tannaz; Ebrahimi-Daryani, Naser; Poustchi, Hossein; Hekmatdoost, Azita

    2016-06-01

    A two-arm randomized open labeled controlled clinical trial was conducted on 50 patients with non-alcoholic fatty liver disease (NAFLD). Participants were assigned to take either a lifestyle modification (LM), or LM +30 g/day brown milled flaxseed for 12 weeks. At the end of the study, body weight, liver enzymes, insulin resistance and hepatic fibrosis and steatosis decreased significantly in both groups (p< 0.05); however, this reduction was significantly greater in those who took flaxseed supplementation (p < 0.05). The significant mean differences were reached in hepatic markers between flaxseed and control group, respectively: ALT [-11.12 compared with -3.7 U/L; P< 0.001], AST [-8.29 compared with -4 U/L; p < 0.001], GGT [-15.7 compared with -2.62 U/L; p < 0.001], fibrosis score [-1.26 compared with -0.77 kPa; p = 0.013] and steatosis score [-47 compared with -15.45 dB/m; p = 0.022]. In conclusion, flaxseed supplementation plus lifestyle modification is more effective than lifestyle modification alone for NAFLD management.

  10. Open-label pilot study of memantine in the treatment of compulsive buying.

    Science.gov (United States)

    Grant, Jon E; Odlaug, Brian L; Mooney, Marc; O'Brien, Robert; Kim, Suck Won

    2012-05-01

    Although compulsive buying (CB) is relatively common, pharmacotherapy research for CB is limited. Memantine, an N-methyl-D-aspartate receptor antagonist, appears to reduce glutamate excitability and improve impulsive behaviors, suggesting it may help individuals with CB. Nine patients (8 females) with CB were enrolled in a 10-week open-label treatment study of memantine (dose ranging from 10 to 30 mg/d). Participants were enrolled from December 2008 until May 2010. The primary outcome measure was change from baseline to study endpoint on the Yale-Brown Obsessive Compulsive Scale-Shopping Version (Y-BOCS-SV). Of the 9 participants, 8 (88.9%) completed the 10-week study. Y-BOCS-SV scores decreased from a mean of 22.0 ± 1.3 at baseline to 11.0 ± 5.3 at endpoint (P buying and improvements on cognitive tasks of impulsivity. In addition, the medication was well-tolerated. These findings suggest that pharmacologic manipulation of the glutamate system may target the impulsive behavior underlying CB. Placebo-controlled, double-blind studies are warranted in order to confirm these preliminary findings in a controlled design.

  11. An open-label pilot study of N-acetylcysteine for skin-picking in Prader-Willi syndrome.

    Science.gov (United States)

    Miller, Jennifer L; Angulo, Moris

    2014-02-01

    Prader-Willi syndrome (PWS) is a complex neurodevelopmental disorder caused by an abnormality on the long arm of chromosome 15 (q11-q13) that results in a host of behavioral characteristics including excessive interest in food, skin picking, difficulty with a change in routine, and obsessive and compulsive behaviors. Skin-picking can result in serious and potentially life-threatening infections. Recent evidence suggests that the excitatory neurotransmitter glutamate is dysregulated in obsessive-compulsive behaviors, and modulation of the glutaminergic pathway may decrease compulsive behaviors, such as recurrent hair pulling or skin-picking behaviors. N-acetylcysteine (NAC), a derivative of the amino acid cysteine, is thought to act either via modulation of NMDA glutamate receptors or by increasing glutathione in pilot studies. Thirty-five individuals with confirmed PWS (ages 5-39 years, 23 females/12 males) and skin-picking behavior for more than 1 year were treated with N-acetylcysteine (Pharma-NAC®) at a dose of 450-1,200 mg/day. Skin-picking symptoms and open lesions were assessed after 12 weeks of treatment by counting and measuring lesions before and after the medication. All 35 individuals had improvement in skin-picking behaviors. Ten (29%) individuals (six males and four females) did not have complete resolution of skin-picking behavior, but had significant reduction in the number of active lesions. Longer-term, placebo-controlled trials are needed to further assess the potential benefit of this treatment.

  12. An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

    Science.gov (United States)

    Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

    2011-01-01

    Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

  13. Open-space preservation in the Netherlands: Planning, practice and prospects

    NARCIS (Netherlands)

    Koomen, E.; Dekkers, J.; Dijk, van T.

    2008-01-01

    Open-space preservation is a planner's issue that is constantly debated, in particular on the success of the implemented instruments. Assessments of policy effectiveness face many methodological problems that are briefly discussed here. We choose to analyse the contribution of Dutch policies to

  14. Open-space preservation in the Netherlands : Planning, practice and prospects

    NARCIS (Netherlands)

    Koomen, Eric; Dekkers, Jasper; van Dijk, Terry

    Open-space preservation is a planner's issue that is constantly debated, in particular on the success of the implemented instruments. Assessments of policy effectiveness face many methodological problems that are briefly discussed here. We choose to analyse the contribution of Dutch policies to

  15. On the Prospects and Concerns of Integrating Open Source Software Environment in Software Engineering Education

    Science.gov (United States)

    Kamthan, Pankaj

    2007-01-01

    Open Source Software (OSS) has introduced a new dimension in software community. As the development and use of OSS becomes prominent, the question of its integration in education arises. In this paper, the following practices fundamental to projects and processes in software engineering are examined from an OSS perspective: project management;…

  16. Bringing Open Educational Practice to a Research-Intensive University: Prospects and Challenges

    Science.gov (United States)

    Masterman, Elizabeth

    2016-01-01

    This article describes a small-scale study that explored the relationship between the pedagogical practices characterised as "open" and the existing model of undergraduate teaching and learning at a large research-intensive university (RIU). The aim was to determine the factors that might enable (conversely impede) the greater uptake of…

  17. On the Prospects and Concerns of Integrating Open Source Software Environment in Software Engineering Education

    Science.gov (United States)

    Kamthan, Pankaj

    2007-01-01

    Open Source Software (OSS) has introduced a new dimension in software community. As the development and use of OSS becomes prominent, the question of its integration in education arises. In this paper, the following practices fundamental to projects and processes in software engineering are examined from an OSS perspective: project management;…

  18. Dexmedetomidine versus propofol in dilatation and curettage: An open-label pilot randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Priyanka Sethi

    2015-01-01

    Full Text Available Background: Traditionally propofol has been used for providing sedation in dilatation and curettage (D and C. Recently, dexmedetomidine has been tried, but very little evidence exists to support its use. Aims: The aim was to compare hemodynamic and recovery profile of both the drugs along with a degree of comfort experienced by patients and the usefulness of the drug to surgeons. Settings and Design: Tertiary care center and open-label randomized controlled trial. Materials and Methods: Patients posted for D and C were enrolled in two groups (25 each. Both groups received fentanyl 1 μg/kg intravenous (IV at the beginning of the procedure. Group P received IV propofol in dose of 1.5 mg/kg over 10-15 min and Group D received dexmedetomidine at a loading dose of 1 μg/kg over 10 min, followed by 0.5 μg/kg/h infusion until Ramsay sedation score reached 3-4. Hemodynamic vitals were compared during and after the procedure. In the recovery room time to reach modified Aldrete score (MAS of 9-10 and patient′s and surgeon′s satisfaction scores were also recorded and compared. Results: In Group D, patients had statistically significant lower heart rate at 2, 5, 10 and 15 min as compared to Group P. Hypotension was present in 52% in Group P and 4% in Group D (P < 0.05. MAS of 9-10 was achieved in 4.4 min in subjects in Group D in contrast to 16.2 min in Group P (P < 0.05. Group D showed higher patient and surgeon satisfaction scores (P < 0.05. Conclusion: Dexmedetomidine provide better hemodynamic and recovery profile than propofol. It can be a superior alternative for short surgical day care procedures.

  19. An open-label pilot trial of minocycline in children as a treatment for Angelman syndrome.

    Science.gov (United States)

    Grieco, Joseph C; Ciarlone, Stephanie L; Gieron-Korthals, Maria; Schoenberg, Mike R; Smith, Amanda G; Philpot, Rex M; Heussler, Helen S; Banko, Jessica L; Weeber, Edwin J

    2014-12-10

    Minocycline, a member of the tetracycline family, has a low risk of adverse effects and an ability to improve behavioral performance in humans with cognitive disruption. We performed a single-arm open-label trial in which 25 children diagnosed with Angelman syndrome (AS) were administered minocycline to assess the safety and tolerability of minocycline in this patient population and determine the drug's effect on the cognitive and behavioral manifestations of the disorder. Participants, age 4-12 years old, were randomly selected from a pool of previously screened children for participation in this study. Each child received 3 milligrams of minocycline per kilogram of body weight per day for 8 weeks. Participants were assessed during 3 study visits: baseline, after 8-weeks of minocycline treatment and after an 8-week wash out period. The primary outcome measure was the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III). Secondary outcome measures included the Clinical Global Impressions Scale (CGI), Vineland Adaptive Behavior Scales 2nd Edition (VABS-II), Preschool Language Scale 4th Edition (PLS-IV) and EEG scores. Observations were considered statistically significant if p VABS-II after treatment with minocycline. Finally, mean scores of the BSID-III self-direction subdomain and CGI scale score were significantly improved both after minocycline treatment and after the wash out period. The clinical and neuropsychological measures suggest minocycline was well tolerated and causes improvements in the adaptive behaviors of this sample of children with Angelman syndrome. While the optimal dosage and the effects of long-term use still need to be determined, these findings suggest further investigation into the effect minocycline has on patients with Angelman syndrome is warranted. NCT01531582 - clinicaltrials.gov.

  20. Awareness of “Predatory” Open-Access Journals among Prospective Veterinary and Medical Authors Attending Scientific Writing Workshops

    Science.gov (United States)

    Christopher, Mary M.; Young, Karen M.

    2015-01-01

    Authors face many choices when selecting a journal for publication. Prospective authors, especially trainees, may be unaware of “predatory” online journals or how to differentiate them from legitimate journals. In this study, we assessed awareness of open-access and predatory journals among prospective authors attending scientific writing workshops; our long-term goal was to inform educational goals for the workshops. We surveyed participants of writing workshops at veterinary and medical schools and an international conference over a 1-year period. The survey included 14 statements for respondents to indicate agreement level on a Likert-like scale and four questions on awareness of resources about predatory journals; respondents also defined “predatory journal.” A total of 145 participants completed the survey: 106 (73.1%) from veterinary schools and 86 (59.3%) graduate students or residents. Fewer faculty (vs trainees) agreed that open access was an important factor in deciding where to publish; faculty and postdoctoral researchers were more likely to expect to pay more to publish in an open-access journal. Most respondents (120/145, 82.7%) agreed/strongly agreed that the decision to accept a manuscript should not be influenced by publication charges, but 50% (56/112) indicated that they “didn’t know” how publishing costs were supported. Of the 142 respondents who answered, 33 (23.0%) indicated awareness of the term “predatory journal”; 34 (23.9%) were aware of the Directory of Open Access Journals; 24 (16.9%) were aware of the Science “sting” article about predatory journals; and 7 (4.8%) were aware of Beall’s list. Most (93/144, 64.5%) definitions of predatory journals described poor but not predatory journal practices, and some respondents misunderstood the term completely. Mentors should help novice authors to be aware of predatory journals and to distinguish between legitimate and illegitimate open-access journals, thus selecting the

  1. [Tunnelled internal jugular vein catheters with taurolidine lock: an acceptable challenge to arterio-venous fistula in 70 years old haemodialyzed patients: a prospective pilot study].

    Science.gov (United States)

    Branger, Bernard; Reboul, Pascal; Prelipcean, Camélia; Noguera, Maria Eugenia; Cariou, Sylvain; Granolleras, Céline; Vecina, Frédérique; Zabadani, Bachir; Boubenider, Samir; Rousseau, Philippe; Deshodt, Gérard; Ramperez, Pierre; Hory, Bernard; Picard, Eric; Branchereau, Pascal; Fabbro-Peray, Pascale; Fourcade, Jacques

    2011-07-01

    Arteriovenous fistula (AVF) is still in 2010 the gold standard of vascular(2) access in haemodialysis (HD) patients. Nevertheless it may be difficult to obtain and/or to use AVF in elderly. With this prospective randomised pilot study, we compare two strategies of vascular access in 70 years old or more new HD patients. AVF were compared to tunnelled jugular vein catheters (TIJC) with taurolidine as bacterial lock solution. Results were as follow: [table: see text] The responses with the visual analogic scale of comfort was 8/10 for TIJC and 5/10 with AVF * Ptaurolidine because of partial clotting of catheters. Albuminemia was significantly lower in AVF failure patients compared to AVF success patients (24.8g/L vs 31.1g/L). This pilot study allows to conclude that TIJC is an acceptable challenge to AVF in haemodialysed patients of 70 years or more in a two years long use.

  2. Information Strategies for Open Government: Challenges and Prospects for Deriving Public Value from Government Transparency

    OpenAIRE

    Sharon S. Dawes; Helbig, Natalie

    2010-01-01

    International audience; Information-based strategies to promote open government offer many opportunities to generate social and economic value through public use of government information. Public and political expectations for the success of these strategies are high but they confront the challenges of making government data "fit for use" by a variety of users outside the government. Research findings from a study of public use of land records demonstrates the inherent complexity of public us...

  3. Open/Distance Teaching Universities Worldwide: Current Challenges and Future Prospects

    OpenAIRE

    Sarah Guri-Rosenblit

    2012-01-01

    This article examines the current challenges faced by open/distance teaching universities worldwide. The challenges relate to: the change of technological and instructional infrastructures; the move from national systems to a global landscape; the need to find appropriate parties for collaboration in the academic and corporate worlds; the search for quality assurance mechanisms; and the digital divide between developing and developed countries, and between poor and rich. The article concludes...

  4. German Cranial Reconstruction Registry (GCRR): protocol for a prospective, multicentre, open registry.

    Science.gov (United States)

    Giese, Henrik; Sauvigny, Thomas; Sakowitz, Oliver W; Bierschneider, Michael; Güresir, Erdem; Henker, Christian; Höhne, Julius; Lindner, Dirk; Mielke, Dorothee; Pannewitz, Robert; Rohde, Veit; Scholz, Martin; Schuss, Patrick; Regelsberger, Jan

    2015-09-30

    Owing to increasing numbers of decompressive craniectomies in patients with malignant middle cerebral artery infarction, cranioplastic surgery becomes more relevant. However, the current literature mainly consists of retrospective single-centre (evidence class III) studies. This leads to a wide variability of technical approaches and clinical outcomes. To improve our knowledge about the key elements of cranioplasty, which may help optimising clinical treatment and long-term outcome, a prospective multicentre registry across Germany, Austria and Switzerland will be established. All patients undergoing cranioplastic surgery in participating centres will be invited to join the registry. Technical methods, materials, medical history, adverse events and clinical outcome measures, including modified Rankin scale and EQ-5D, will be assessed at several time points. Patients will be accessible to inclusion either at initial decompressive surgery or when cranioplasty is planned. Scheduled monitoring will be carried out at time of inclusion and subsequently at time of discharge, if any readmission is necessary, and at follow-up presentation. Cosmetic results and patient satisfaction will also be assessed. Collected data will be managed and statistically analysed by an independent biometric institute. The primary endpoint will be mortality, need for operative revision and neurological status at 3 months following cranioplasty. Ethics approval was obtained at all participating centres. The registry will provide reliable prospective evidence on surgical techniques, used materials, adverse events and functional outcome, to optimise patient treatment. We expect this study to give new insights in the treatment of skull defects and to provide a basis for future evidence-based therapy regarding cranioplastic surgery. This trial is indexed in the German Clinical Trials Register (DRKS-ID: DRKS00007931). The Universal Trial Number (UTN) is U1111-1168-7425. Published by the BMJ

  5. Norfloxacin as prophylaxis against urethral strictures following transurethral resection of the prostate: an open, prospective, randomized study.

    Science.gov (United States)

    Hammarsten, J; Lindqvist, K

    1993-11-01

    An open, prospective, randomized study was performed to investigate the effect of norfloxacin prophylaxis on stricture formation and operative outcome after transurethral resection of the prostate. After resection, the 359 patients studied were randomly divided into 2 groups: 1) those given norfloxacin as prophylaxis for 15 days following removal of the catheter (norfloxacin group) and 2) those given no antimicrobial prophylaxis during the same period (control group). Of the patients 94 were excluded. At followup 6 to 12 months postoperatively, the number of strictures in the anterior urethra was 2 of 135 in the norfloxacin group and 22 of 130 in the control group (p norfloxacin group, fewer patients in that group were dissatisfied with the operative outcome. The results suggest that norfloxacin provides effective prophylaxis against stricture formation after transurethral resection of the prostate.

  6. The effects of amisulpride on five dimensions of psychopathology in patients with schizophrenia: a prospective open- label study

    Directory of Open Access Journals (Sweden)

    Fresan Ana

    2005-05-01

    Full Text Available Abstract Background The efficacy of antipsychotics can be evaluated using the dimensional models of schizophrenic symptoms. The D2/D3-selective antagonist amisulpride has shown similar efficacy and tolerability to other atypical antipsychotics. The aim of the present study was to determine the efficacy of amisulpride on the dimensional model of schizophrenic symptoms and tolerability in latin schizophrenic patients. Method Eighty schizophrenic patients were enrolled and 70 completed a prospective open-label 3-month study with amisulpride. The schizophrenic symptoms, psychosocial functioning and side-effects were evaluated with standardized scales. Results The patients showed significant improvement in the five dimensions evaluated. Amisulpride (median final dose 357.1 mg/d was well-tolerated without treatment-emergent extrapyramidal side-effects. Conclusion Amisulpride showed efficacy on different psychopathological dimensions and was well tolerated, leading to consider this drug a first line choice for the treatment of schizophrenia.

  7. Topical tretinoin 0.1% for pregnancy-related abdominal striae: an open-label, multicenter, prospective study.

    Science.gov (United States)

    Rangel, O; Arias, I; García, E; Lopez-Padilla, S

    2001-01-01

    In an open-label, multicenter, prospective study, 20 women applied tretinoin (retinoic acid) cream 0.1% daily for 3 months to pregnancy-related stretch marks in the abdominal area. Efficacy was evaluated by analysis of one preselected target lesion, which was rated on a six-point scale (-1 = worse to 4 = cleared). At week 12, significant global improvement was noted from baseline in all stretch marks, and the target lesion decreased in length by 20% (P = .01). Erythema and scaling, the most common adverse events, occurred in 11 patients, decreased in severity after the first month of treatment, and were controlled with continued application of tretinoin and petroleum jelly ointment. In this small study, topical application of tretinoin significantly improved the clinical appearance of pregnancy-related stretch marks.

  8. Laparoscopic versus open colectomy for TNM stage III colon cancer: results of a prospective multicenter study in Italy.

    Science.gov (United States)

    Guerrieri, Mario; Campagnacci, Roberto; De Sanctis, Angelo; Lezoche, Giovanni; Massucco, Paolo; Summa, Massimo; Gesuita, Rosaria; Capussotti, Lorenzo; Spinoglio, Giuseppe; Lezoche, Emanuele

    2012-11-01

    There is still debate about the practicality of performing laparoscopic colectomy instead of open colectomy for patients with curable cancer, although laparoscopic surgery is now being performed even for patients with advanced colon cancer. We compared the long-term results of laparoscopic versus open colectomy for TNM stage III carcinoma of the colon in a large series of patients followed up for at least 3 years. The subjects of this prospective non-randomized multicentric study were 290 consecutive patients, who underwent open surgery (OS group; n = 164) or laparoscopic surgery (LS group; n = 126) between 1994 and 2005, at one of the four surgical centers. The same surgical techniques were used for the laparoscopic and open approaches to right and left colectomy. The distribution of TNM substages (III A, III B, IIIC) as well as the grading of carcinomas (G1, G2, G3) were similar in each arm of the study. The median follow-up periods were 76.9 and 58.0 months after OS and LS, respectively. There were 10 (6.1 %) versus 9 (7.1 %) deaths unrelated to cancer, 15 (9.1 %) versus 5 (4 %) cases of local recurrence, 7 (4.2 %) versus 5 (4 %) cases of peritoneal carcinosis, and 37 (22.5 %) versus 14 (11.1 %) cases of metastases in the OS and LS groups, respectively. There was also one case of port-site recurrence after LS (0.8 %). The OS group had a significantly higher probability of local recurrence and metastases (p cancer-related death (p = 0.001) than the LS group. These findings support that LS is safe and effective for advanced carcinoma of the colon. Although the LS group in this study had a significantly better long-term outcome than the OS group, further investigations are needed to draw a definitive conclusion.

  9. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    Science.gov (United States)

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  10. Escitalopram in the treatment of patients with schizophrenia and obsessive-compulsive disorder: an open-label, prospective study.

    Science.gov (United States)

    Stryjer, Rafael; Dambinsky, Yael; Timinsky, Igor; Green, Tamar; Kotler, Moshe; Weizman, Abraham; Spivak, Baruch

    2013-03-01

    The current data suggest that up to 50% of patients with schizophrenia have obsessive-compulsive (OC) symptoms coexisting with psychosis and between 7.8 and 46% of schizophrenia patients also have full-blown obsessive-compulsive disorder (OCD). The aim of this study was to examine the efficacy of the most selective serotonin reuptake inhibitor escitalopram in the management of OCD in schizophrenia patients. The study was an open-label prospective trial of 12 weeks' duration in which escitalopram at a dose of up to 20 mg/day was added to the existing antipsychotic drug regimen in schizophrenia patients with OCD. Fifteen patients (10 men/five women) with the diagnosis of schizophrenia and OCD were recruited for the study (mean age: 39±14, range 21-61 years) and received escitalopram according to the study design. A significant improvement was observed in the total Yale Brown Obsessive-Compulsive Scale (Y-BOCS) scores and in the scores of both the Y-BOCS-Obsession and the Y-BOCS-Compulsion subscale at the end point. In addition, a significant improvement was observed in the total scores of the Positive and Negative Syndrome Scale and particularly in scores of anxiety, tension, depression, and preoccupation items. No adverse effects of escitalopram were reported by patients during the trial. In our prospective 12-week open-label study, escitalopram 20 mg/day was well tolerated and improved OC symptoms in schizophrenia patients. Our preliminary results are encouraging and a double-blind randomized study is required to confirm our results.

  11. Delimiting the Prospect of Openness: An Examination of Initial Student Approaches to E-Learning

    Directory of Open Access Journals (Sweden)

    Christopher Naughton

    2011-02-01

    Full Text Available When converting from a paper-based distance mode to an online mode of teaching, certain expectations arise that students may engage not only in the development of extended research activity but that the quality of discussion and thinking will change. With access to open-ended discussion within the online forum the opportunity is afforded to students to share ideas and in turn develop their shared knowledge, a facility denied to them when in the paper distance mode. However, in a recent study conducted in New Zealand, it was shown that despite having access to online forums students moving to an online platform refrained from participation in this social exchange. A possible explanation for this indifference was thought to be the students realising that the online exchange made no impact on their assessment. Hence, the collaborative rhetoric of Web 2.0 made little impact when the summative evaluation remained unchanged from previous paper-based assessment. This paper reports on the introduction of online learning at a private tertiary college in New Zealand and describes the response of students who found difficulty in reconciling a community of learners and openness within what was perceived as an evaluation that remained individualistic and competitive in nature.

  12. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial.

    Science.gov (United States)

    Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

    2015-11-01

    Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)-the best evidence-based treatment for insomnia-has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18-65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted

  13. Corrosion of metals and alloys - Corrosion and fouling in industrial cooling water systems - Part 1: Guidelines for conducting pilot-scale evaluation of corrosion and fouling control additives for open recirculating cooling water systems

    CERN Document Server

    International Organization for Standardization. Geneva

    2006-01-01

    Corrosion of metals and alloys - Corrosion and fouling in industrial cooling water systems - Part 1: Guidelines for conducting pilot-scale evaluation of corrosion and fouling control additives for open recirculating cooling water systems

  14. Alemtuzumab in lung transplantation: an open-label, randomized, prospective single center study.

    Science.gov (United States)

    Jaksch, P; Ankersmit, J; Scheed, A; Kocher, A; Muraközy, G; Klepetko, W; Lang, G

    2014-08-01

    Induction therapy with alemtuzumab followed by lower maintenance immunosuppression (IS) has been associated with reduced morbidity and mortality in abdominal and heart transplantation (TX). In the current study, alemtuzumab, in combination with reduced levels of maintenance IS, was compared to thymoglobulin in combination with standard IS. Sixty consecutive patients who underwent lung transplantation (LUTX) at a single center were prospectively randomized in two groups: group A received alemtuzumab in conjunction with reduced doses of tacrolimus, steroids and mycophenolate mofetil. Group B received thymoglobulin in association with standard dose IS. Patient and graft survival, freedom from acute cellular rejection (ACR), lymphocytic bronchiolitis, bronchiolitis obliterans syndrome, kidney function, infectious complications and posttransplant lymphoproliferative disorder were analyzed. Alemtuzumab induction therapy resulted in complete the absence of ACR episodes ≥ A2 within the first year post-TX. The difference to thymoglobulin was significant (alemtuzumab 0 vs. ATG 0.33; p = 0.019). All other factors studied did not show any differences between the two groups. Alemtuzumab induction therapy after LUTX in combination with reduced maintenance IS significantly reduces higher-grade rejection rates. This novel therapeutic agent had no impact on survival, infections rates, kidney function and incidence of malignancies.

  15. The effects of hyperbaric oxygen therapy on oxidative stress, inflammation, and symptoms in children with autism: an open-label pilot study

    Directory of Open Access Journals (Sweden)

    Melnyk Stepan

    2007-11-01

    Full Text Available Abstract Background Recently, hyperbaric oxygen therapy (HBOT has increased in popularity as a treatment for autism. Numerous studies document oxidative stress and inflammation in individuals with autism; both of these conditions have demonstrated improvement with HBOT, along with enhancement of neurological function and cognitive performance. In this study, children with autism were treated with HBOT at atmospheric pressures and oxygen concentrations in current use for this condition. Changes in markers of oxidative stress and inflammation were measured. The children were evaluated to determine clinical effects and safety. Methods Eighteen children with autism, ages 3–16 years, underwent 40 hyperbaric sessions of 45 minutes duration each at either 1.5 atmospheres (atm and 100% oxygen, or at 1.3 atm and 24% oxygen. Measurements of C-reactive protein (CRP and markers of oxidative stress, including plasma oxidized glutathione (GSSG, were assessed by fasting blood draws collected before and after the 40 treatments. Changes in clinical symptoms, as rated by parents, were also assessed. The children were closely monitored for potential adverse effects. Results At the endpoint of 40 hyperbaric sessions, neither group demonstrated statistically significant changes in mean plasma GSSG levels, indicating intracellular oxidative stress appears unaffected by either regimen. A trend towards improvement in mean CRP was present in both groups; the largest improvements were observed in children with initially higher elevations in CRP. When all 18 children were pooled, a significant improvement in CRP was found (p = 0.021. Pre- and post-parental observations indicated statistically significant improvements in both groups, including motivation, speech, and cognitive awareness (p Conclusion In this prospective pilot study of children with autism, HBOT at a maximum pressure of 1.5 atm with up to 100% oxygen was safe and well tolerated. HBOT did not appreciably

  16. A new prospect on the approach to open, complex, craniofacial trauma.

    Science.gov (United States)

    Robotti, E; Forcht Dagi, T; Ravegnani, M; Bocchiotti, G

    1992-01-01

    Complex craniofacial trauma has been traditionally managed in three stages: urgent craniotomy, secondary orbitofacial repair and delayed cranioplasty. Departing from this conventional approach, we employ an early single-stage neuro and plastic-surgical reconstruction for patients presenting open cranial wounds of the frontobasilar region coexisting with orbitofacial fractures. Neurological outcome does not seem to be affected by the additional operating time, nor is the incidence of infection raised, although bone fragments are repositioned, primary bone grafting is employed, and metallic material is used for fixation. Adequate direct exposure followed by reduction and rigid internal fixation results in primary bone healing and permits to avoid the difficult complications related to soft tissue contracture over misaligned bone. Compared with the conventional staged approach, immediate reconstruction appears functionally and aesthetically preferable, as well as technically easier.

  17. Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder

    Directory of Open Access Journals (Sweden)

    Berlant Jeffrey L

    2004-08-01

    Full Text Available Abstract Background In order to confirm therapeutic effects of topiramate on posttraumatic stress disorder (PTSD observed in a prior study, a new prospective, open-label study was conducted to examine acute responses in chronic, nonhallucinatory PTSD. Methods Thirty-three consecutive newly recruited civilian adult outpatients (mean age 46 years, 85% female with DSM-IV-diagnosed chronic PTSD, excluding those with concurrent auditory or visual hallucinations, received topiramate either as monotherapy (n = 5 or augmentation (n = 28. The primary measure was a change in the PTSD Checklist-Civilian Version (PCL-C score from baseline to 4 weeks, with response defined as a ≥ 30% reduction of PTSD symptoms. Results For those taking the PCL-C at both baseline and week 4 (n = 30, total symptoms declined by 49% at week 4 (paired t-test, P Conclusions Promising open-label findings in a new sample converge with findings of a previous study. The use of topiramate for treatment of chronic PTSD, at least in civilians, warrants controlled clinical trials.

  18. Open wedge metatarsal osteotomy versus crescentic osteotomy to correct severe hallux valgus deformity - A prospective comparative study.

    Science.gov (United States)

    Wester, Jens Ulrik; Hamborg-Petersen, Ellen; Herold, Niels; Hansen, Palle Bo; Froekjaer, Johnny

    2016-03-01

    Different techniques of proximal osteotomies have been introduced to correct severe hallux valgus. The open wedge osteotomy is a newly introduced method for proximal osteotomy. The aim of this prospective randomized study was to compare the radiological and clinical results after operation for severe hallux valgus, comparing the open wedge osteotomy to the crescentic osteotomy which is our traditional treatment. Forty-five patients with severe hallux valgus (hallux valgus angle >35̊, and intermetatarsal angle >15̊) were included in this study. The treatment was proximal open wedge osteotomy and fixation with plate (Hemax), group 1, or operation with proximal crescentic osteotomy and fixation with a 3mm cannulated screw, group 2. The mean age was 52 years (19-71). Forty-one females and four males were included. Clinical and radiological follow-ups were performed 4 and 12 months after the operation. In group 1 the hallux valgus angle decreased from 39.0̊ to 24.1̊ after 4 months and 27.9̊ after 12 months. In group 2 the angle decreased from 38.3̊ to 21.4̊ after 4 months and 27.0̊ after 12 months. The intermetatarsal angle in group 1 was 19.0̊ preoperatively, 11.6̊ after 4 months and 12.6̊ after 12 months. In group 2 the mean intermetatarsal angle was 18.9̊ preoperatively, 12.0̊ after 4 months and 12.6̊ after 12 months. The AOFAS score improved from 59.3 to 81.5 in group 1 and from 61.8 to 84.8 in group 2 respectively measured 12 months postoperatively. The relative length of the 1 metatarsal compared to 2 metatarsal bone was 0.88 and 0.87 preoperatively and 0.88 and 0.86 for group 1 and 2 respectively measured after 12 months. Crescentic osteotomy and open wedge osteotomy improve AOFAS score and VAS scores on patients operated with severe hallux valgus. No significant difference was found in the two groups looking at the postoperative improvement of HVA and IMA measured 4 and 12 months postoperatively. The postoperative VAS score and AOFAS score were

  19. Present status and future prospect of the open utilization in HIMAC

    Energy Technology Data Exchange (ETDEWEB)

    Soga, Fuminori [Accelerator Physics and Engineering and Head of the Open Utilization System in HIMAC, National Institute of Radiological Sciences, STA, Chiba (Japan)

    1998-12-31

    The first medically-dedicated heavy ion accelerator facility in the world was constructed at NIRS and the treatment of cancer patients began in June, 1994. A number of the treated patients exceeds 500 in 4.5 years. In a fiscal year of 1997, a number of accepted proposals is 129 and a number of the outside users is 330. HIMAC is operated 24 hours from Tuesday to Friday while the treatment is carried out in the daytime. The rest of the beam time (nights and weekends) is used for these researches under this utilization system. Beam time provided to the users in FY 1997 is 2800 hours for the clinical trial and 3100 hours for the open utilization. Ion species are C (3760 hs), Ar (460 hs), Si (380 hs), Ne (270 hs), He (170 hs) and H{sub 2}{sup +} (160 hs). The beams of Fe and Kr will be added in a list of available ions. These increase of beam time is largely due to development of the time sharing mode in the linac system. Proposal from abroad increases gradually. For example, the NASA group is interested in using the beam in HIMAC for their research. The problem is the shortage of manpower who guides and helps the outside groups and infrastructure such as electronics or machine shops and accommodations, although they are indispensable for smooth running of the research. (J.P.N.)

  20. An open-label pilot study to assess the effectiveness of krill oil with added vitamins and phytonutrients in the relief of symptoms of PMS

    Directory of Open Access Journals (Sweden)

    Wakeman MP

    2013-09-01

    Full Text Available Michael P Wakeman School of Cancer Sciences, University of Birmingham, Edgbaston, Birmingham, West Midlands, UK Abstract: An open-label pilot study over 4 months to evaluate the effectiveness of a compound formulation of ingredients, which individually have been demonstrated to be implicated in the pathogenesis of premenstrual syndrome to ameliorate the most troublesome symptoms of the condition. The supplement provided thiamine, riboflavin, pyridoxine, vitamin D, soy isoflavones, rosemary extract, and krill oil and was taken each day for the 3 months of the trial. Statistically significant effect was reported by the 29 women who completed the study in relief of anxiety, bloating, mood swings, breast tenderness, skin outbreaks, food cravings, fatigue, forgetfulness, insomnia, and headache after 3 months of treatment compared with baseline. This pilot study indicates the formulation to be effective, and a larger placebo-controlled trial is now planned. Keywords: thiamine, riboflavin, pyridoxine, vitamin D, soy isoflavones, rosemary extract, premenstrual syndrome

  1. The efficacy of the modified Atkins diet in North Sea Progressive Myoclonus Epilepsy: an observational prospective open-label study.

    Science.gov (United States)

    van Egmond, Martje E; Weijenberg, Amerins; van Rijn, Margreet E; Elting, Jan Willem J; Gelauff, Jeannette M; Zutt, Rodi; Sival, Deborah A; Lambrechts, Roald A; Tijssen, Marina A J; Brouwer, Oebele F; de Koning, Tom J

    2017-03-07

    North Sea Progressive Myoclonus Epilepsy is a rare and severe disorder caused by mutations in the GOSR2 gene. It is clinically characterized by progressive myoclonus, seizures, early-onset ataxia and areflexia. As in other progressive myoclonus epilepsies, the efficacy of antiepileptic drugs is disappointingly limited in North Sea Progressive Myoclonus Epilepsy. The ketogenic diet and the less restrictive modified Atkins diet have been proven to be effective in other drug-resistant epilepsy syndromes, including those with myoclonic seizures. Our aim was to evaluate the efficacy of the modified Atkins diet in patients with North Sea Progressive Myoclonus Epilepsy. Four North Sea Progressive Myoclonus Epilepsy patients (aged 7-20 years) participated in an observational, prospective, open-label study on the efficacy of the modified Atkins diet. Several clinical parameters were assessed at baseline and again after participants had been on the diet for 3 months. The primary outcome measure was health-related quality of life, with seizure frequency and blinded rated myoclonus severity as secondary outcome measures. Ketosis was achieved within 2 weeks and all patients completed the 3 months on the modified Atkins diet. The diet was well tolerated by all four patients. Health-related quality of life improved considerably in one patient and showed sustained improvement during long-term follow-up, despite the progressive nature of the disorder. Health-related quality of life remained broadly unchanged in the other three patients and they did not continue the diet. Seizure frequency remained stable and blinded rating of their myoclonus showed improvement, albeit modest, in all patients. This observational, prospective study shows that some North Sea Progressive Myoclonus Epilepsy patients may benefit from the modified Atkins diet with sustained health-related quality of life improvement. Not all our patients continued on the diet, but nonetheless we show that the modified

  2. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    Science.gov (United States)

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

  3. Efficacy of Atomoxetine for the Treatment of ADHD Symptoms in Patients with Pervasive Developmental Disorders: A Prospective, Open-Label Study

    Science.gov (United States)

    Fernandez-Jaen, Alberto; Fernandez-Mayoralas, Daniel Martin; Calleja-Perez, Beatriz; Munoz-Jareno, Nuria; Campos Diaz, Maria del Rosario; Lopez-Arribas, Sonia

    2013-01-01

    Objective: Atomoxetine's tolerance and efficacy were studied in 24 patients with pervasive developmental disorder and symptoms of ADHD. Method: Prospective, open-label, 16-week study was performed, using the variables of the Clinical Global Impression Scale and the Conners' Scale, among others. Results: A significant difference was found between…

  4. Improvement of QOL and Immunological Function With Lentinula Edodes Mycelia in Patients Undergoing Cancer Immunotherapy: An Open Pilot Study.

    Science.gov (United States)

    Tanigawa, Keishi; Itoh, Yusuke; Kobayashi, Yasunobu

    2016-07-01

    Context • Combined treatment with an extract of Lentinula edodes mycelia (LEM) and chemotherapy has been reported to improve quality of life (QOL) and immunological function in cancer patients. However, those effects have not been elucidated for patients receiving cancer immunotherapy. Objective • The present study intended to investigate the effects of oral LEM on QOL and immunological function in cancer patients receiving immunotherapy. Design • The research team designed an open-label, single-armed pilot study. Setting • The study took place at Bio-Thera Clinic, a facility associated with Tokyo Women's Medical University in Tokyo, Japan. Participants • The participants were 10 cancer patients undergoing cancer immunotherapy at Bio-Thera Clinic. Intervention • The participants received either dendritic cell (DC)-based cancer vaccine therapy or CD3-activated T-lymphocyte (CAT) therapy as immunotherapy. They received the immunotherapy only for the first 4 wk of the study, and then oral LEM (1800 mg/d) was added for the next 4 wk. Outcome Measures • Preintervention and at 4 and 8 wk after the start of the study, participants completed a QOL survey, and immunological parameters were measured. Results • Participants' QOL symptom scores increased (ie, worsened) by 5.1 ± 1.7 during the first 4 wk of treatment when they were receiving immunotherapy only, but it decreased (ie, improved) by -2.5 ± 1.6 during the next 4 wk when the immunotherapy was combined with the LEM, P immunotherapy combined with LEM showed that the amount of interferon-γ (IFN-γ) produced in the peripheral blood tended to increase as compared with that during the first 4 wk of immunotherapy only. The rise in IFN-γ was correlated with changes in several regulatory T cells (Tregs) (ie, forkhead box P3 [FOXP3]+/cluster of differentiation 4 [CD4]+ and transforming growth factor beta [TGF-β]). Conclusions • The findings suggest that a combined treatment of LEM and immunotherapy might

  5. Multicenter, prospective, open-label, observational study of bimatoprost 0.01% in patients with primary open-angle glaucoma or ocular hypertension

    Directory of Open Access Journals (Sweden)

    Laube T

    2012-05-01

    Full Text Available Stefan Pfennigsdorf,1 Osman Ramez,2 Gerrit von Kistowski,3 Birgit Mäder,4 Peter Eschstruth,5 Michael Froböse,6 Ulrich Thelen,7 Christoph Spraul,8 Dietmar Schnober,9 Hazel Cooper,10 Thomas Laube111Polch Ophthalmology Practice, Polch, 2Buxtehude Ophthalmology Practice, Buxtehude, 3Nürnberg Ophthalmology Practice, Nürnberg, 4Weißwasser Ophthalmology Practice, Weißwasser, 5Ophthalmology Practice, Kiel, 6Ophthalmology Practice, Bielefeld, 7Group Practice, Münster, 8Group Practice, Ulm, 9Ophthalmology Practice, Werdohl, Germany; 10Allergan, Marlow, UK, 11Group Practice, Düsseldorf, GermanyBackground: Bimatoprost 0.01% was developed for improved tolerability over bimatoprost 0.03%, while maintaining efficacy in lowering intraocular pressure (IOP. This multicenter, prospective, open-label, observational study was designed to investigate the efficacy and tolerability of bimatoprost 0.01% in routine clinical practice.Methods: Data were collected from 10,337 patients with primary open-angle glaucoma or ocular hypertension attending 1334 centers in Germany. The primary efficacy outcome was mean change in IOP in each eye from baseline to 10–14 weeks after initiation of bimatoprost 0.01%. Target IOP, prior therapies, additional treatments, and adverse events were also assessed. All treatment decisions were at the physicians’ discretion.Results: Bimatoprost 0.01% significantly lowered mean IOP from baseline by –4.1 mmHg (P < 0.0001 in all patients after a mean of 10.45 weeks. In patients without previous treatment, bimatoprost 0.01% reduced mean IOP from baseline by –6.5 mmHg (P < 0.0001. Bimatoprost 0.01% also significantly reduced IOP in patients previously treated with monotherapy of β-blockers, prostaglandin analogs, carbonic anhydrase inhibitors or bimatoprost 0.03%. No adverse events were reported by 93.9% of patients during treatment with bimatoprost 0.01%; the most commonly reported adverse events were eye irritation (2.0%, ocular

  6. Maternal Stress and Young Children's Behavioural Development: A Prospective Pilot Study from 8 to 36 Months in a Finnish Sample

    Science.gov (United States)

    Haapsamo, Helena; Pollock-Wurman, Rachel A.; Kuusikko-Gauffin, Sanna; Ebeling, Hanna; Larinen, Katja; Soini, Hannu; Moilanen, Irma

    2013-01-01

    The relationship between maternal parenting stress and infant/toddler behavioural development was examined in a longitudinal pilot study. Fifty mothers reported parenting stress via the Parenting Stress Index-Short Form when their infants were eight months old. Parents subsequently rated their children's emotional and behavioural problems with the…

  7. Onabotulinumtoxin A Treatment of Drooling in Children with Cerebral Palsy: A Prospective, Longitudinal Open-Label Study

    DEFF Research Database (Denmark)

    Møller, Eigild; Pedersen, Søren Anker; Vinicoff, Pablo Gustavo;

    2015-01-01

    The aim of this prospective open-label study was to treat disabling drooling in children with cerebral palsy (CP) with onabotulinumtoxin A (A/Ona, Botox®) into submandibular and parotid glands and find the lowest effective dosage and least invasive method. A/Ona was injected in 14 children, Mean...... age 9 years, SD 3 years, under ultrasonic guidance in six successive Series, with at least six months between injections. Doses and gland involvement increased from Series A to F (units (U) per submandibular/parotid gland: A, 10/0; B, 15/0; C, 20/0; D, 20/20; E, 30/20; and F, 30/30). The effect...... in E and F, but with swallowing problems ≤5 weeks in 3 of 28 treatments. F had largest VAS and UWS reduction (64% and 49%). We recommend: Start with dose D A/Ona (both submandibular and parotid glands and a total of 80 U) and increase to E and eventually F (total 120 U) without sufficient response....

  8. The role of long-term doxycycline in patients of idiopathic pulmonaryfibrosis: The results of an open prospective trial

    Directory of Open Access Journals (Sweden)

    Bhattacharyya Parthasarathi

    2009-01-01

    Full Text Available Objective: To evaluate the effect of long term use of doxycycline in IPF patients. Materials and Methods: Patients of IPF, selected randomly from out patient services and diagnosed on the basis of HRCT chest, were put on doxycycline in an open prospective trial. They were followed up with monitoring of subjective well being along with measurement of pulse rate and arterial oxygen saturation at rest and after a fixed and certain exercise, forced vital capacity, six minutes walk test, St Georges Respiratory questionnaire, and serial chest X-rays. Results: Out of seven patients put on doxycycline, six of them continued the drug for a mean period of 531.43 (± 328.88 days. All the patients tolerated the drug well and had shown uniform subjective and overall objective improvement in all the parameters concerned; the change in the radiological parameter being statistically significant. Conclusion: Doxycycline merits an appropriate clinical trial in the management of idiopathic pulmonary fibrosis. This widely used and relatively safe drug can add a new dimension to the therapeutic regimen. However, further in-depth studies will be required to evaluate its role in the management of IPF.

  9. Local Anesthesia in Open Inguinal Hernia Repair Improves Postoperative Quality of Life Compared to General Anesthesia: A Prospective, International Study.

    Science.gov (United States)

    Huntington, Ciara R; Wormer, Blair A; Cox, Tiffany C; Blair, Laurel J; Lincourt, Amy E; Augenstein, Vedra A; Heniford, B Todd

    2015-07-01

    The choice of general (GA) versus local anesthesia (LA) in open inguinal hernia repair (OIHR) has a substantial financial impact and may influence clinical outcomes. Our study compares postoperative quality of life (QOL) in patients undergoing OIHR under LA versus GA. A cooperative prospective study from centers in 10 countries was performed through the International Hernia Mesh Registry from 2007 to 2012. QOL was compared at one, six, 12, and 24 months for LA versus GA with univariate and multivariate analysis controlling for known confounding variables. Of 1128 patients who underwent OIHR, 585(52%) used GA and 533(48%) used LA. Most were male (92%) with unilateral (94%), primary (91%) repairs with a mean age 57 ± 16 years. There was no difference (P > 0.05) in age, gender, operative time, mesh size, length of stay, infection, recurrence, reoperation, or death. Multivariate analysis demonstrated significant QOL differences between groups: GA had higher odds of discomfort at one and six months [odds ratio (OR) 3.3, 2.0], movement limitation at one and six months (OR 3.5, 2.8), and mesh sensation at one and 12 months (OR 2.9, 1.8). Overall, patients undergoing OIHR under LA had improved postoperative QOL in the short and long term compared with GA.

  10. The use of amniotic membrane in trabeculectomy for the treatment of primary open-angle glaucoma: a prospective study

    Directory of Open Access Journals (Sweden)

    Stavrakas P

    2012-02-01

    Full Text Available Panagiotis Stavrakas1, Gerasimos Georgopoulos1, Maria Milia1, Dimitris Papaconstantinou1, Maria Bafa2, Efthymios Stavrakas2, Mihalis Moschos11Department of Ophthalmology, University of Athens Medical School, General Hospital of Athens (Geniko Kratiko Hospital, Athens, Greece; 2Department of Ophthalmology, Thriassio General Hospital, Athens, GreeceBackground: To investigate the effectiveness of amniotic membrane transplantation (AMT on improving the outcomes of trabeculectomy in primary open-angle glaucoma (POAG.Methods: Fifty-nine eyes affected by primary open-angle glaucoma were enrolled in this prospective randomized study. Thirty-two eyes underwent amnion-shielded trabeculectomy (study group and 27 eyes underwent trabeculectomy without any antimetabolites (control group. Success was defined as intraocular pressure (IOP <21 mmHg without any medications at 24 months follow-up. The two groups were compared in terms of IOP, bleb morphology, bleb survival and risk of failure, glaucoma medications, and complications.Results: There was no statistically significant difference in terms of postoperative IOP between the two groups and at 24 months median IOP was 15.5 mmHg for the AMT group and 16 mmHg for the control group. IOP postoperative reduction was 8 mmHg for the AMT group versus 6 mmHg for the non AMT group (P = 0.276. Two patients from the study group developed IOP >21 mmHg in contrast to seven patients from the classic trabeculectomy group. The study group had 61.0% less risk of developing IOP >21 mmHg (P = 0.203. No major complications in the AMT group were observed. AMT blebs were diffuse with mild vascularization.Conclusion: In patients with POAG, AMT showed favorable effects on bleb survival, however data failed to provide firm evidence that AMT could be used as a routine procedure in trabeculectomy.Keywords: amniotic membrane, trabeculectomy, primary open-angle glaucoma, glaucoma filtering blebIn memory of Professor Mihalis Moschos. "We

  11. Argon plasma coagulation treatment of anal high-grade squamous intraepithelial lesions in men who have sex with men living with HIV: results of a 2-year prospective pilot study.

    Science.gov (United States)

    de Pokomandy, A; Rouleau, D; Lalonde, R; Beauvais, C; de Castro, C; Coutlée, F

    2017-08-23

    Men who have sex with men (MSM) living with HIV are at high risk for anal high-grade squamous intraepithelial lesions (HSILs) and cancer. The best management of anal HSIL remains unclear. Our objective was to assess whether argon plasma coagulation (APC) could be safe, well tolerated and efficient to treat anal HSILs in MSM living with HIV. A prospective phase II, open-label, pilot study was conducted to evaluate APC to treat anal HSILs in 20 HIV-positive MSM. Participants were followed for 2 years after their first treatment. Twenty men with persistent HSILs completed the 2-year study. Their baseline median CD4 count was 490 cells/μL and 85% had undetectable HIV viral loads. Overall, 65% (13/20) of participants were clear of HSILs at their 24-month visit. The initial response rates after the first, second and third APC treatments were 45%, 44% and 67%, respectively, but recurrences were common. The main side effect was pain during and within 1 week after the treatments. There were no long-term side effects, nor serious adverse events related to the procedure. Cost is a drawback. APC can be used to treat anal HSILs in HIV-seropositive MSM, and requires repeated treatment because of a high recurrence rate. As successful treatment of human papillomavirus (HPV) infection or eradication of the anal transitional zone remains impossible, HSIL treatment is challenging and requires long-term follow-up. © 2017 British HIV Association.

  12. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

    DEFF Research Database (Denmark)

    Qintar, Mohammed; George, Jason J; Panko, Melanie

    2015-01-01

    consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study......) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1. RESULTS: The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD...

  13. The Impact of Type 2 Diabetes on the Efficacy of ADP Receptor Blockers in Patients with Acute ST Elevation Myocardial Infarction: A Pilot Prospective Study

    Directory of Open Access Journals (Sweden)

    Matej Samoš

    2016-01-01

    Full Text Available Background. The aim of this study was to validate the impact of type 2 diabetes (T2D on the platelet reactivity in patients with acute ST elevation myocardial infarction (STEMI treated with adenosine diphosphate (ADP receptor blockers. Methods. A pilot prospective study was performed. Totally 67 patients were enrolled. 21 patients had T2D. Among all study population, 33 patients received clopidogrel and 34 patients received prasugrel. The efficacy of ADP receptor blocker therapy had been tested in two time intervals using light transmission aggregometry with specific inducer and vasodilator-stimulated phosphoprotein phosphorylation (VASP-P flow cytometry assay. Results. There were no significant differences in platelet aggregability among T2D and nondiabetic (ND group. The platelet reactivity index of VASP-P did not differ significantly between T2D and ND group (59.4±30.9% versus 60.0±25.2% and 33.9±25.3% versus 38.6±29.3% in second testing. The number of ADP receptor blocker nonresponders did not differ significantly between T2D and ND patients. The time interval from ADP receptor blocker loading dosing to the blood sampling was similar in T2D and ND patients in both examinations. Conclusion. This prospective study did not confirm the higher platelet reactivity and higher prevalence of ADP receptor blocker nonresponders in T2D acute STEMI patients.

  14. Is There a Benefit to Drains with a Kocher-Langenbeck Approach? A Prospective Randomized Pilot Study

    Science.gov (United States)

    2010-11-01

    Athletic Care Dauterive Orthopaedics and Sports Med- icine Suite 280, 500 North Lewis New Iberia, LA 70563; Statistician, United States Institute of...HO, Kaukonen JP, Salo SA. Drainage is of no use in primary uncomplicated cemented hip and knee arthroplasty for osteoarthritis : a prospective

  15. A Prospective, Open Label, Observational Study to Assess the Safety and Efficacy of Herbal Cough Syrup Mykoff® in Patients Suffering from Cough of Varied Aetiologies

    OpenAIRE

    Mangesh Bhalerao; Pradip Awale; Abhijeet Sawle; Dhananjay Sangle; Devendra B Sonawane; Vilas Chavan

    2013-01-01

    A prospective, open label, observational study was conducted at general outpatient clinic to assess the safety and efficacy of herbal cough syrup Mykoff® in patients suffering from cough of varied aetiologies. The patients of either sex, age > 3yrs, suffering from cough due to common cold, mild to moderate upper respiratory tract infections, allergic cough and smoker’s cough were enrolled. The safety was evaluated by means of an analysis of adverse events. In addition, efficacy and tolerabili...

  16. Diabetes-specific enteral nutrition formula in hyperglycemic, mechanically ventilated, critically ill patients: a prospective, open-label, blind-randomized, multicenter study

    OpenAIRE

    Mesejo, Alfonso; Montejo-González, Juan Carlos; Vaquerizo-Alonso, Clara; Lobo-Tamer, Gabriela; Zabarte-Martinez, Mercedes; Herrero-Meseguer, Jose Ignacio; Acosta-Escribano, Jose; Blesa-Malpica, Antonio; Martinez-Lozano, Fátima

    2015-01-01

    Introduction Although standard enteral nutrition is universally accepted, the use of disease-specific formulas for hyperglycemic patients is still controversial. This study examines whether a high-protein diabetes-specific formula reduces insulin needs, improves glycemic control and reduces ICU-acquired infection in critically ill, hyperglycemic patients on mechanical ventilation (MV). Methods This was a prospective, open-label, randomized (web-based, blinded) study conducted at nine Spanish ...

  17. Evaluation of efficacy and tolerability of eperisone and thiocolchicoside in treatment of low back pain associated with muscle spasm: An open label, prospective, randomized controlled trial

    OpenAIRE

    Syed H. Maaz; Prakash N. Khandelwal; Shiraz M. Baig; Sudhakar M. Doifode; Ulhas M. Ghotkar

    2016-01-01

    Background: Low back pain has a high prevalence in adult population. Because of reflex muscle spasm, muscle relaxants are frequently used either alone or in combination with analgesics. Eperisone inhibits voltage gated sodium channels in brain stem and Thiocolchicoside acts via GABA-mediated mechanism to relax muscle spasm and relieves pain. Methods: This was a prospective; open labeled, randomized, two-arm, parallel group, controlled, clinical trial. 113 patients were randomised to two gr...

  18. Arthroscopic Versus Open Latarjet in the Treatment of Recurrent Anterior Shoulder Dislocation With Marked Glenoid Bone Loss: A Prospective Comparative Study.

    Science.gov (United States)

    Zhu, Yiming; Jiang, Chunyan; Song, Guanyang

    2017-06-01

    Very few studies have compared open Latarjet versus arthroscopic Latarjet procedures. To compare the clinical and computed tomographic outcomes between open and arthroscopic Latarjet procedures. Cohort study; Level of evidence, 3. A prospective, comparative study was performed. The open Latarjet group included 44 patients, and the arthroscopic Latarjet group included 46 patients. All patients had more than 2 years of clinical follow-up (range of motion, American Shoulder and Elbow Surgeons [ASES] score, Constant-Murley score, and Rowe score). The position of the transferred coracoid, the screw orientation, and graft resorption were evaluated on computed tomography (CT) scan. The surgery time for the open group was significantly shorter than that for the arthroscopic group ( P = .003). No recurrent dislocation occurred in either group. The apprehension test was negative in all patients in both groups. At the final follow-up, no significant difference was detected between the open group and the arthroscopic group regarding any of the clinical outcome measurements. The transferred coracoid graft was level with the glenoid in all patients in both groups. The open group had better position in the superior-inferior direction compared with the arthroscopic group ( P Latarjet group showed notably less graft resorption compared with patients in the open Latarjet group.

  19. Prospective, unmasked evaluation of the iStent® inject system for open-angle glaucoma: synergy trial.

    Science.gov (United States)

    Voskanyan, Lilit; García-Feijoó, Julián; Belda, Jose I; Fea, Antonio; Jünemann, Anselm; Baudouin, Christophe

    2014-02-01

    Micro-invasive glaucoma surgical implantation of trabecular micro-bypass stents, previously shown to be safe and effective for open-angle glaucoma (OAG) subjects during cataract surgery, was considered for evaluation as a sole procedure. The aim of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy after ab interno implantation of two Glaukos Trabecular Micro-Bypass iStent inject second generation devices in subjects with OAG. This study was performed at sites in France, Germany, Italy, Republic of Armenia, and Spain. In this pan-European, multi-center prospective, post-market, unmasked study, 99 patients with OAG on at least two topical ocular hypotensive medications who required additional IOP lowering to control glaucoma disease underwent implantation of two GTS400 stents in a stand-alone procedure. Patients were qualified if they presented with preoperative mean IOP between 22 and 38 mmHg after medication washout. Postoperatively, subjects were assessed at Day 1, Months 1, 3, 6, 7, 9, and 12. IOP, medication use and safety were assessed at each visit. Sixty-six percent of subjects achieved IOP ≤18 mmHg at 12 months without medication, and 81% of subjects achieved Month 12 IOP ≤ 18 mmHg with either a single medication or no medication. Mean baseline washout IOP values decreased by 10.2 mmHg or 39.7% from 26.3 (SD 3.5) mmHg to 15.7 (SD 3.7) mmHg at Month 12. Mean IOP at 12 months was 14.7 (SD 3.1) mmHg in subjects not using ocular hypotensive medications. Reduction from preoperative medication burden was achieved in 86.9% of patients, including 15.2% with reduction of one medication and 71.7% with reduction of two or more medications. Postoperative complications occurred at a low rate and resolved without persistent effects. In this series, implantation of two trabecular micro-bypass second generation stents in subjects with OAG resulted in IOP and medication reduction and favorable safety outcomes.

  20. Oral versus intramuscular cobalamin treatment in megaloblastic anemia: a single-center, prospective, randomized, open-label study.

    Science.gov (United States)

    Bolaman, Zahit; Kadikoylu, Gurhan; Yukselen, Vahit; Yavasoglu, Irfan; Barutca, Sabri; Senturk, Taskin

    2003-12-01

    Cobalamin (vitamin B12) deficiency, the most common cause of megaloblastic anemia, is treated with intramuscular (IM) cobalamin. It has been suggested by some investigators that oral (p.o.) cobalamin treatment may be as effective in the treatment of this condition, with the advantages of ease of administration and lower cost. This study assessed the effects and cost of p.o. versus i.m. cobalamin treatment in patients with megaloblastic anemia due to cobalamin deficiency. This was a 90-day, prospective, randomized, open-label study conducted at the Division of Hematology, Department of Internal Medicine, Adnan Menderes University Research and Practice Hospital (Aydin, Turkey). Patients aged > or =16 years with megaloblastic anemia due to cobalamin deficiency were randomized to receive 1000-microg cobalamin p.o. once daily for 10 days (p.o. group) or 1000-microg cobalamin i.m. once daily for 10 days (i.m. group). After 10 days, both treatments were administered once a week for 4 weeks, and after that, once a month for life. Patients were assessed for the presence of reticulocytosis between treatment days 5 and 10 until it was detected. Therapeutic effectiveness was assessed by measuring hematologic parameters on days 0, 10, 30, and 90 and serum vitamin B12 concentration on days 0 and 90. The Mini-Mental State Examination was used before and after the B12 therapy for cognitive function assessment and 125-Hz diapozone was used for vibration threshold testing. Neurologic sensory assessment, including soft-touch and pinprick examinations, was used to identify neuropathy at baseline and study end. Tolerability was assessed using laboratory tests and patient interview. Cost was assessed using the cost of the study drug and of the injection. Sixty patients completed the study 26 in the p.o. group (16 men, 10 women; mean [SD] age, 60 [15] years) and 34 in the i.m. group (17 men, 17 women; mean [SD] age, 64 [10] years). Reticulocytosis was observed in all patients. In the p

  1. Prospective, open-label study to validate proper use of the Versacloz™ (clozapine oral suspension kit by people with schizophrenia

    Directory of Open Access Journals (Sweden)

    Andre AD

    2015-05-01

    Full Text Available Anthony D Andre Interface Analysis Associates, Saratoga, CA, USA Purpose: This study was designed to validate that people with schizophrenia can correctly, safely, and effectively prepare doses of Versacloz™ using the Versacloz oral suspension kit and instructions for use (IFU.Materials and methods: This was a prospective, open-label, simulated-use validation study of 61 people with schizophrenia who were stabilized on clozapine or were clozapine-naive and stabilized on another antipsychotic treatment. Participants were randomized to one of two groups: untrained (n=46 and trained (n=15. Participants were asked to select the proper syringe and prepare two test doses of 1, 3.5, or 5 mL, as randomly assigned. Participants in the untrained group did not receive any training on using the kit, but had access to kit materials, including packaging and the IFU; both test dose preparations were unaided. Participants in the trained group received brief training from the moderator, and then prepared one test dose during training and one unaided test dose during the study period. Prepared placebo doses were not ingested. Performance and behavior were assessed in 14 critical tasks identified in the user failure mode and effects analysis. Test dose failures or dose errors (threshold ±0.1 mL were assessed. Subjective participant assessments of usability were captured in interviews and IFU comprehension was probed.Results: A total of 107 test doses were prepared: 92 and 15 by the untrained and trained groups, respectively. Overall success for unassisted dose preparation was 87.9%; all test failures (failure to shake the bottle or failure to obtain the correct test dose occurred in the untrained group. All participants selected the correct syringe for their assigned dose.Conclusion: This study shows that the Versacloz oral suspension kit and IFU can be correctly, safely, and effectively used to prepare doses by people with schizophrenia, with few instances of

  2. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study

    National Research Council Canada - National Science Library

    Naik, Aanand D; White, Craig D; Robertson, Suzanne M; Armento, Maria E A; Lawrence, Briana; Stelljes, Linda A; Cully, Jeffrey A

    2012-01-01

    .... A small open trial was conducted to test the acceptability, feasibility and preliminary outcomes of a telephone-delivered coaching intervention for rural-dwelling older adults with uncontrolled...

  3. The MOTIV-HEART Study: A Prospective, Randomized, Single-Blind Pilot Study of Brief Strategic Therapy and Motivational Interviewing among Cardiac Rehabilitation Patients

    Science.gov (United States)

    Pietrabissa, Giada; Manzoni, Gian Mauro; Rossi, Alessandro; Castelnuovo, Gianluca

    2017-01-01

    Background: Psychological distress, biomedical parameters, and unhealthy lifestyles contribute to a poorer prognosis for cardiac disease. Public health's challenge is to motivate patients to utilize self-care. Objective: This prospective, randomized, single-blind pilot study aimed at testing the incremental efficacy of Brief Strategic Therapy (BST) combined with Motivational Interviewing (MI) in improving selected biomedical and psychological outcomes over and beyond those of the stand-alone BST in a residential Cardiac Rehabilitation (CR) program. Method: Fourty-two inpatients (17 females), enrolled in a 1-month CR program, were randomly allocated into two conditions: (a) Three sessions of BST and (b) Three sessions of BST plus MI. Data were collected at baseline, discharge, and after 3 months through phone interviews. Results: At discharge, no significant between-group difference was found in any outcome variable. Changes from pre- to post-treatment within each condition showed significant improvements only in the BST group, where the level of external regulation diminished, and both the participants' self-regulation (Relative Autonomous Motivation Index, RAI) and willingness to change improved. At the 3-month follow-up, within-group analyses on responders (BST = 9; BST + MI = 11) showed a statistically significant improvement in the level of systolic blood pressure in both groups. Discussion: Findings showed no evidence of the incremental efficacy of combining BST and MI over and beyond BST alone on either selected biomedical or psychological outcomes among CR patients. Conclusions: Ends and limitations from the present pilot study should be considered and addressed in future investigations. PMID:28223950

  4. Early individualised manipulative rehabilitation following lumbar open laser microdiscectomy improves early post-operative functional disability: A randomized, controlled pilot study.

    Science.gov (United States)

    Kim, Byungho J; Ahn, Junghoon; Cho, Heecheol; Kim, Dongyun; Kim, Taeyeong; Yoon, Bumchul

    2016-01-01

    Lumbar open laser microdiscectomy has been shown to be an effective intervention and safe approach for lumbar disc prolapse. However early post-operative physical disability affecting daily activities have been sporadically reported. To evaluate the feasibility of using early individualised manipulative rehabilitation to improve early post-operative functional disability following lumbar discectomy. Randomised controlled pilot trial. Setting at a major metropolitan spine surgery hospital. Twenty-one patients aged 25-69 years who underwent lumbar microdiscectomy were randomised to either the manipulative rehabilitation treatment group or the active control group. Rehabilitation was initiated 2-3 weeks after surgery, twice a week for 4 weeks. Each session was for 30 minutes. Primary outcomes were the Roland-Morris disability questionnaire and the visual analogue pain scale. Outcome measures were assessed at baseline and post-intervention. Early post-operative physical disability was improved with a 55% reduction by early individualised manipulative rehabilitation, compared to that of control care with a 5% increase. Early post-operative residual leg pain decreased with rehabilitation (55%) and control care (9%). This pilot study supports the feasibility of a future definitive randomised control trial and indicates this type of rehabilitation may be an important option for post-operative management after spinal surgery.

  5. A pilot, prospective evaluation of a novel alternative for maintenance therapy of breast cancer-associated lymphedema [ISRCTN76522412

    Directory of Open Access Journals (Sweden)

    Rockson Stanley G

    2006-03-01

    Full Text Available Abstract Background Prospective investigations of complete decongestive lymphatic physiotherapy (CDPT, including manual lymphatic drainage (MLD, have validated the efficacy of these interventions for the initial reduction of edema and long-term maintenance of limb volume in lymphedema. However, CDPT demands substantial time and effort from patients to maintain these benefits; the treatments are not always well-accepted, and patients may suffer from a deterioration in quality-of-life or a time-dependent loss of initial treatment benefits. A new device designed for home use by the patient, the Flexitouch™, has been developed to mechanically simulate MLD. We have undertaken a prospective, randomized, crossover study of the efficacy of the Flexitouch™, when compared to massage, in the self-administered maintenance therapy of lymphedema. Methods A prospective, randomized, crossover study of maintenance therapy was performed in 10 patients with unilateral breast cancer-associated lymphedema of the arm. Each observation phase included self-administered treatment with the Flexitouch™ or massage, 1 hour daily for 14 days, respectively, followed by crossover to the alternate treatment phase. Each treatment phase was preceded by a 1 week treatment washout, with use of garment only. The sequence of treatment was randomly assigned. The potential impact of treatment modality on quality of life was assessed with serial administration of the SF-36. Results Statistical analysis disclosed that the order of treatment had no outcome influence, permitting 10 comparisons within each treatment group. Post-treatment arm volume reduced significantly after the Flexitouch™, but not after self-administered massage. The patients' mean weight decreased significantly with Flexitouch™ use, but not with massage. The Flexitouch™ device was apparently well-tolerated and accepted by patients. Serial SF-36 administration showed no deterioration in physical or

  6. Open Access am Standort D – erweiterte Perspektiven für die Wissenschaft / Open Access in Germany – new prospects for science and scholarship

    Directory of Open Access Journals (Sweden)

    Ilg-Hartbecke, Karin

    2009-06-01

    Full Text Available The increasing implementation of the Open Access idea has given rise to new scholarly information-supply and communication models in both the German and international research landscapes. For example, over half the research-oriented universities in Germany now operate their own institutional repository. In the long term, Open Access repositories represent an ideal basic infrastructure for handling scholarly publications since they offer worldwide accessibility, enhanced visibility and value-added services such as disciplinary and cross-disciplinary search options, usage statistics and citation analysis. This contribution provides an up-to-date overview and describes not only the current framework conditions and developments but also the barriers to development in the German repository landscape. It also deals with initiatives designed to introduce publishers, authors and general information providers to Open Access practices.

  7. A daily-life-oriented intervention to improve prospective memory and goal-directed behaviour in ageing: a pilot study.

    Science.gov (United States)

    Burkard, Christina; Rochat, Lucien; Blum, Anaëlle; Emmenegger, Joëlle; Juillerat Van der Linden, Anne-Claude; Van der Linden, Martial

    2014-01-01

    Difficulties in the execution of goal-directed behaviours, and particularly their prospective memory component, can arise in ageing and have important consequences for autonomy. The first objective of this article is to present an intervention that trained older individuals who reported prospective memory or goal-directed behaviour problems to use "implementation intentions". This technique, which has been shown to improve different aspects of goal-directed behaviour enactment, consists of establishing a mental (verbal and/or visual) link between the action that must be performed and the situation in which it must be performed. Our programme proposes exercises of progressively increasing difficulty that are targeted at daily life situations. Our second objective was to test the programme in small groups of older adults. Preliminary data regarding the programme's feasibility and its initial efficacy show a significant improvement in the main outcome measure, a questionnaire assessing goal-directed behaviours in everyday life. The participants also reported being significantly less bothered by their difficulties, although there were no significant changes in quality of life, self-esteem, anxiety or depression. Two participants with different psychological profiles, who benefited differently from the intervention, are then presented in more detail.

  8. Clinical and Financial Impact of Pharmacist Involvement in Discharge Medication Reconciliation at an Academic Medical Center: A Prospective Pilot Study.

    Science.gov (United States)

    Sebaaly, Jamie; Parsons, Laura Beth; Pilch, Nicole A Weimert; Bullington, Wendy; Hayes, Genevieve L; Easterling, Heather

    2015-06-01

    Medication reconciliation is one of the more challenging aspects of inpatient care, and its accuracy is paramount to safe transitions of care. Studies have shown that pharmacists have a role in medication reconciliation through improving patient safety and avoiding costs associated with medication errors. The wide-scale use of pharmacists in this process has been limited by time constraints, cost, and lack of resources. This study evaluates the impact of pharmacists in resolving medication errors, decreasing readmission rates, and reducing institutional costs during the discharge medication reconciliation process. Pharmacists evaluated discharge medication reconciliation documentation for patients to determine its accuracy, the accuracy of the admission reconciliation documentation, and any potential issues unrelated to accuracy. Analysis of these data determined the time required for pharmacist involvement, the number of errors identified by pharmacists, the quality of pharmacist interventions, the cost avoidance for each error, and the overall impact on hospital readmission. During the 7-week study period, pharmacists performed 67 discharge medication reviews and identified 84 errors. Seventy-five percent were considered to be significant and 6% were considered to be serious. The 30-day readmission rate in the study cohort was 18% compared with 20% in the control group. Based on the clinical severity scale and pharmacist salaries, pharmacist interventions resulted in $42,300 in cost avoidance. Pharmacists involved in this pilot discharge process identified and resolved significant errors on medication reconciliation orders that resulted in a financial benefit to the institution.

  9. Spin-adapted open-shell time-dependent density functional theory. II. Theory and pilot application.

    Science.gov (United States)

    Li, Zhendong; Liu, Wenjian; Zhang, Yong; Suo, Bingbing

    2011-04-07

    The excited states of open-shell systems calculated by unrestricted Kohn-Sham-based time-dependent density functional theory (U-TD-DFT) are often heavily spin-contaminated and hence meaningless. This is solved ultimately by the recently proposed spin-adapted time-dependent density functional theory (TD-DFT) (S-TD-DFT) [J. Chem. Phys. 133, 064106 (2010)]. Unlike the standard restricted open-shell Kohn-Sham-based TD-DFT (R-TD-DFT) which can only access the singlet-coupled single excitations, the S-TD-DFT can capture both the singlet- and triplet-coupled single excitations with the same computational effort as the U-TD-DFT. The performances of the three approaches (U-TD-DFT, R-TD-DFT, and S-TD-DFT) are compared for both the spin-conserving and spin-flip excitations of prototypical open-shell systems, the nitrogen (N(2)(+)) and naphthalene (C(10)H(8)(+)) cations. The results show that the S-TD-DFT gives rise to balanced descriptions of excited states of open-shell systems.

  10. Use of cinacalcet in nephrolithiasis associated with normocalcemic or hypercalcemic primary hyperparathyroidism: results of a prospective randomized pilot study

    Directory of Open Access Journals (Sweden)

    Simone Brardi

    2015-03-01

    Full Text Available Objectives: To evaluate, by means of a prospective randomized study, the efficacy of cinacalcet in the forms of nephrolithiasis associated with primary hyperparathyroidism in both the hypercalcemic and normocalcemic variant. Materials and Methods: Ten patients suffering from active nephrolithiasis associated with primary hyperparathyroidism (4 hypercalcemics and 6 normocalcemics, equally divided between males and females, were randomly but not blindly addressed to treatment with potassium citrate and allopurinol, or to the same therapeutic regimen in combination with cinacalcet. The dosage of cinacalcet was optimized for each patient in order to obtain a reduction of parathyroid hormone (PTH within normal limits while enabling the maintenance of adequate calcemic values. All study participants were given the same diet based on a reduction in sodium intake, oxalate-rich foods and animal protein with standardized intake of calcium and an increase in hydration. After a follow up period of 10 months , cinacalcet was associated to standard therapy and diet in patients who were not taken it, conversely cinacalcet was withdrawn in the remaining patients who remained on standard therapeutic regimen and diet. Follow up was continued for a second period of observation of the same duration of the first. Results: At the end of the period of treatment with cinacalcet, for both variants of hyperparathyroidism, a statistically significant reduction in the overall number and in the diameter of renal stones was found. Conclusions: This prospective randomized study shows the effectiveness of cinacalcet used in combination with a diet with normalized calcium intake, in reducing the number and size of urinary stones in hypercalemic and normocalcemic forms of primary hyperparathyroidism.

  11. Effectiveness of teriparatide treatment on back pain-related functional limitations in individuals affected by severe osteoporosis: a prospective pilot study

    Science.gov (United States)

    Iolascon, Giovanni; Gimigliano, Francesca; Malavolta, Nazzarena; Tarantino, Umberto; Fornari, Rachele; Greco, Emanuela; Di Pietro, Gioconda; Gimigliano, Raffaele; Lenzi, Andrea; Resmini, Giuseppina; Migliaccio, Silvia

    2012-01-01

    Summary Introduction Vertebral fractures have been associated with back pain, functional limitations and reduced health-related quality of life (HRQoL). Teriparatide is the first effective anabolic agent that demonstrated to significantly reduce the risk of vertebral fracture by 65%, as compared to placebo. The aims of this study were to evaluate the effectiveness of teriparatide treatment on back pain-related functional limitations and to investigate on patients HRQoL. Materials and methods In this prospective observational pilot study osteoporotic patients, who were prescribed teriparatide therapy and a supplementation of calcium and vitamin D, were asked to answer to two self-administered questionnaires: the Spine Pain Index (SPI) and the SF-12 (at the recruitment, after 6, 12, and 18 months). Results Fifty-two women were evaluated (mean age of 70.58 yrs). The mean SPI score passed from 50.01 at baseline to 32.20 at 18 months. The mean SF-12 PCS score passed from 30.00 at baseline to 36.79 at 18 months, while the mean SF-12 MCS score was already within the normality range at baseline, constantly improving during the 18 months. Conclusion In conclusion, 18 months of treatment with teriparatide has to be considered an effective therapeutic option for women with severe osteoporosis and vertebral fractures, in a real-life clinical setting, to improve both back pain related disability and quality of life. PMID:23289031

  12. Maximum mouth opening and trismus in 143 patients treated for oral cancer: A 1-year prospective study

    NARCIS (Netherlands)

    Wetzels, J.G.H.; Merkx, M.A.W.; Haan, A.F.J. de; Koole, R.; Speksnijder, C.M.

    2014-01-01

    BACKGROUND: Patients with oral cancer can develop restricted mouth opening (trismus) because of the oncologic treatment. METHODS: Maximum mouth opening (MMO) was measured in 143 patients shortly before treatment and 0, 6, and 12 months posttreatment, and the results were analyzed using a linear

  13. Birch pollen influence the severity of atopic eczema – prospective clinical cohort pilot study and ex vivo penetration study

    Directory of Open Access Journals (Sweden)

    Fölster-Holst R

    2015-10-01

    Full Text Available Regina Fölster-Holst,1 Jagoda Galecka,1 Sigo Weißmantel,1 Ute Dickschat,2 Frank Rippke,3 Kerstin Bohnsack,3 Thomas Werfel,4 Katja Wichmann,4 Matthias Buchner,1 Thomas Schwarz,1 Annika Vogt,5 Jürgen Lademann,5 Martina C Meinke5 1Department of Dermatology, Venerology and Allergy, University of Kiel, 2Wörth, 3Beiersdorf AG, Hamburg, 4Department of Dermatology, Venerology and Allergy, Division of Immunodermatology and Allergy Research, Hannover Medical School, Hannover, 5Department of Dermatology, Venerology and Allergology, Charité – Universitätsmedizin Berlin, Berlin, Germany Abstract: There is little clinical evidence for a correlation between the severity of atopic eczema (AE and pollen exposition. To obtain more data, we performed a clinical cohort pilot study about the influence of pollen on AE between sensitized and nonsensitized subjects and an experimental study addressing the cutaneous penetration of pollen into the skin. Fifty-five patients were monitored during birch pollen season. To study the cutaneous penetration, grass pollen allergens were applied on excised skin and the uptake in CD1c-expressing dendritic cells was investigated. The correlation between environmental pollen load and severity of the Scoring Atopic Dermatitis (SCORAD score and pruritus was observed, regardless of the status of sensitization. The sensitized group recovered significantly worse after the birch pollen season. Remarkably higher amounts of pollen allergens taken up by CD1c cells were detected in epidermal cells derived from skin explants with a disturbed epidermal barrier. These findings suggest an exacerbating role of pollen in AE utilizing the epidermal route. Keywords: aeroallergens, atopic eczema, seasonality, skin antigen-presenting cells, skin barrier penetration

  14. Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

    2017-04-01

    Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m(2) and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  15. Retraction statement: Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers.

    Science.gov (United States)

    2015-09-01

    The following article from Journal of Clinical Nursing, 'Manuka honey vs. hydrogel - a prospective, open label, multicentre, randomised controlled trial to compare desloughing efficacy and healing outcomes in venous ulcers' by Georgina Gethin and Seamus Cowman published online on 25 August 2008 in Wiley Online Library (wileyonlinelibrary.com) and in Volume 18, pp. 466-474, has been retracted by agreement between the journal Editor-in-Chief, the authors and John Wiley & Sons, Ltd. The retraction has been agreed due to errors in the data analysis which affect the article's findings.

  16. Nefazodone in psychotic unipolar and bipolar depression: a retrospective chart analysis and open prospective study on its efficacy and safety versus combined treatment with amitriptyline and haloperidol.

    Science.gov (United States)

    Grunze, Heinz; Marcuse, Alain; Schärer, Lars O; Born, Christoph; Walden, Jörg

    2002-01-01

    Although atypical antipsychotics are on the rise, traditional treatment of psychotic (or delusional) depression mostly includes the addition of classical antipsychotics to antidepressants. As there are only few data supporting this approach compared with antidepressant monotherapy, and almost no data comparing it with antidepressants of the latest generation, we conducted a retrospective chart analysis and a prospective, randomized open study on the efficacy and tolerability of nefazodone monotherapy versus combined treatment with amitriptyline and haloperidol in psychotic depression. The results suggest that the addition of classical antipsychotics should be reserved for those with very severe psychotic symptoms, but may not be needed in milder forms.

  17. Minimally invasive lumbar interbody fusion via MAST Quadrant retractor versus open surgery: a prospective randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    WANG Hong-li; L(U) Fei-zhou; JIANG Jian-yuan; MA Xin; XIA Xin-lei; WANG Li-xun

    2011-01-01

    Background In recent years,a variety of minimally invasive lumbar surgery techniques have achieved desirable efficacy,but some dispute remains regarding the advantages over open surgery.This study aimed to compare minimally invasive lumbar interbody fusion via MAST Quadrant retractor with open surgery in terms of perioperative factors,postoperative back muscle function,and 24-month postoperative follow-up results.Methods From September 2006 to June 2008,patients with single-level degenerative lumbar spine disease who were not responsive to conservative treatment were enrolled in this study.Patients were randomized to undergo either minimally invasive surgery (MIS,transforaminal lumbar interbody fusion via MAST Quadrant retractor,41 cases) or open surgery (improved transforaminal lumbar interbody fusion,38 cases).Results The MIS group had longer intraoperative fluoroscopy time than the open surgery group,and the open surgery group had significantly increased postoperative drainage volume and significantly prolonged postoperative recovery time compared with the MIS group (P <0.05 for all).MRI scanning showed that the T2 relaxation time in the multifidus muscle was significantly shorter in the MIS group than in the open surgery group at 3 months after surgery (P <0.01).Surface electromyography of the sacrospinalis muscle showed that the average discharge amplitude and frequency were significantly higher in the MIS group than in the open surgery group (P <0.01).The Oswestry disability index and visual analog scale scores were better at 3,6,12 and 24 months postoperatively than preoperatively in both groups.Both groups of patients met the imaging convergence criteria at the last follow-up.Conclusions MIS can effectively reduce sacrospinalis muscle injury compared with open surgery,which is conducive to early functional recovery.In the short term,MIS is superior to open surgery,but in the long term there is no significant difference between the two procedures.

  18. Multiparametric Approach Enhances Detection of Patients with Cerebral TIAs at Risk of Stroke: A Prospective Pilot Case Series

    Science.gov (United States)

    Abd-Allah, Foad; Tawfik, Tarek Zoheir; Shamloul, Reham Mohammed; Hegazy, Montasser M; Hashad, Assem; Kamel, Ayman Ismail; Farees, Dina; Shalaby, Nevin M

    2016-01-01

    Background Patients with transient ischemic attack (TIA) are generally clinically unstable, with fear of developing a handicapping stroke. Identification of those at highest and lowest risk of stroke in the first days and weeks after a TIA would allow appropriate use of worthy secondary prevention strategies. Objective Incorporation of a clinical scoring system, neurovascular imaging, and magnetic resonance-diffusion-weighted imaging (MR-DWI) to help predicting risk of developing an ischemic stroke following a TIA. Subjects and methods A prospective observational study was conducted on 25 patients with TIAs, 64% were females, and 26% were males, with a mean age of 57±10.36. Patients were assessed clinically and an ABCD2 score was applied. Patients have undergone diffusion-weighted imaging (DWI), within 24 h from the event, and intra- and extracranial duplex study. Patients were followed up at intervals of one week, three months, six months, and one year. Results Six patients (24%) developed stroke on their follow-up, most of them (83.3%) had their strokes within the first three months and had an initial ABCD2 score of ≥4. The development of stroke was associated with the presence of significant extra and/or intracranial vessel disease (P=0.006) and the presence of acute lesions on their DWI (P=0.035). Conclusion Incorporation of brain MR-DWIs and neurovascular imaging together with the ABCD2 score improves prediction of ischemic stroke following TIA. PMID:27403225

  19. Transconjunctival retinopexy with active external drainage of subretinal fluid: a prospective pilot study of eight consecutive cases.

    Science.gov (United States)

    Siqueira, Rubens Camargo; Jorge, Rodrigo; Scott, Ingrid Ursula

    2007-01-01

    To describe an alternative surgical technique for the management of retinal detachment with no or minimal proliferative vitreoretinopathy (grade B) using transconjunctival retinopexy with active external drainage of subretinal fluid. In a prospective, interventional study, eight consecutive patients with retinal detachment with no or minimal proliferative vitreoretinopathy (grade B) underwent transconjunctival retinopexy with active external drainage of subretinal fluid. Transconjunctival external drainage of subretinal fluid was achieved by using a 29 gauge needle placed in the subretinal space under indirect ophthalmoscopic monitoring. Active suction was performed (500 mmHg vacuum) using a vitrectomy line coupled to the needle. After retinal reattachment, cryotherapy was applied to the scleral region corresponding to the area of the retinal break(s). In all cases there was retinal attachment at the end of surgery. Retinal redetachment occurred in four pseudophakic patients who then underwent pars plana vitrectomy. The four phakic patients maintained retinal attachment during follow-up (13-20 months). Transconjunctival retinopexy with active external drainage of subretinal fluid represents a useful, faster, and cheaper alternative to scleral buckling for retinal detachments with no or minimal proliferative retinopathy in phakic patients and, unlike scleral buckling, is not associated with induced myopia.

  20. Integrating a prospective pilot trial and patient-derived xenografts to trace metabolic changes associated with acute myeloid leukemia.

    Science.gov (United States)

    Carrabba, Matteo G; Tavel, Laurette; Oliveira, Giacomo; Forcina, Alessandra; Quilici, Giacomo; Nardelli, Francesca; Tresoldi, Cristina; Ambrosi, Alessandro; Ciceri, Fabio; Bernardi, Massimo; Vago, Luca; Musco, Giovanna

    2016-10-28

    Despite the considerable progress in understanding the molecular bases of acute myeloid leukemia (AML), new tools to link disease biology to the unpredictable patient clinical course are still needed. Herein, high-throughput metabolomics, combined with the other "-omics" disciplines, holds promise in identifying disease-specific and clinically relevant features.In this study, we took advantage of nuclear magnetic resonance (NMR) to trace AML-associated metabolic trajectory employing two complementary strategies. On the one hand, we performed a prospective observational clinical trial to identify metabolic changes associated with blast clearance during the first two cycles of intensive chemotherapy in nine adult patients. On the other hand, to reduce the intrinsic variability associated with human samples and AML genetic heterogeneity, we analyzed the metabolic changes in the plasma of immunocompromised mice upon engraftment of primary human AML blasts.Combining the two longitudinal approaches, we narrowed our screen to seven common metabolites, for which we observed a mirror-like trajectory in mice and humans, tracing AML progression and remission, respectively. We interpreted this set of metabolites as a dynamic fingerprint of AML evolution.Overall, these NMR-based metabolomic data, to be consolidated in larger cohorts and integrated in more comprehensive system biology approaches, hold promise for providing valuable and non-redundant information on the systemic effects of leukemia.

  1. Integrating a prospective pilot trial and patient-derived xenografts to trace metabolic changes associated with acute myeloid leukemia

    Directory of Open Access Journals (Sweden)

    Matteo G. Carrabba

    2016-10-01

    Full Text Available Abstract Despite the considerable progress in understanding the molecular bases of acute myeloid leukemia (AML, new tools to link disease biology to the unpredictable patient clinical course are still needed. Herein, high-throughput metabolomics, combined with the other “-omics” disciplines, holds promise in identifying disease-specific and clinically relevant features. In this study, we took advantage of nuclear magnetic resonance (NMR to trace AML-associated metabolic trajectory employing two complementary strategies. On the one hand, we performed a prospective observational clinical trial to identify metabolic changes associated with blast clearance during the first two cycles of intensive chemotherapy in nine adult patients. On the other hand, to reduce the intrinsic variability associated with human samples and AML genetic heterogeneity, we analyzed the metabolic changes in the plasma of immunocompromised mice upon engraftment of primary human AML blasts. Combining the two longitudinal approaches, we narrowed our screen to seven common metabolites, for which we observed a mirror-like trajectory in mice and humans, tracing AML progression and remission, respectively. We interpreted this set of metabolites as a dynamic fingerprint of AML evolution. Overall, these NMR-based metabolomic data, to be consolidated in larger cohorts and integrated in more comprehensive system biology approaches, hold promise for providing valuable and non-redundant information on the systemic effects of leukemia.

  2. A Prospective Randomized Trial to Assess Fixation Strategies for Severe Open Tibia Fractures: Modern Ring External Fixators Versus Internal Fixation (FIXIT Study).

    Science.gov (United States)

    OʼToole, Robert V; Gary, Joshua L; Reider, Lisa; Bosse, Michael J; Gordon, Wade T; Hutson, James; Quinnan, Stephen M; Castillo, Renan C; Scharfstein, Daniel O; MacKenzie, Ellen J

    2017-04-01

    The treatment of high-energy open tibia fractures is challenging in both the military and civilian environments. Treatment with modern ring external fixation may reduce complications common in these patients. However, no study has rigorously compared outcomes of modern ring external fixation with commonly used internal fixation approaches. The FIXIT study is a prospective, multicenter randomized trial comparing 1-year outcomes after treatment of severe open tibial shaft fractures with modern external ring fixation versus internal fixation among men and women of ages 18-64. The primary outcome is rehospitalization for major limb complications. Secondary outcomes include infection, fracture healing, limb function, and patient-reported outcomes including physical function and pain. One-year treatment costs and patient satisfaction will be compared between the 2 groups, and the percentage of Gustilo IIIB fractures that can be salvaged without soft tissue flap among patients receiving external fixation will be estimated.

  3. A pilot muon radiography to image the shallow conduit of the Stromboli volcano: results and future prospects

    Science.gov (United States)

    Miyamoto, Seigo; Tioukov, Valeri; Sirignano, Chiara; Bozza, Cristiano; Morishima, Kunihiro

    2017-04-01

    The test result of imaging the shallow part of the Stromboli crater zone by using cosmic-ray muons in 2012 and possible performance of the future muon observation will be presented. It is well known that the behavior of volcanic eruptions strongly depends on the shape of the conduit. Stromboli is one of the most known and studied active volcanoes in the world, nevertheless the details of its internal structure are not well defined yet. Geophysical exploration method which use high energy cosmic-ray muons and makes the density image of the object like X-ray radiography for the human body is called "muon radiography " or "muography". A pilot muography was done for the shallow part of Stromboli in 2012. We succeeded to clarify that there is a less density part at the North-East cone in the crater zone. It is considered that the stack of volcanic ashes. On the other hand, we also confirmed that the contamination of the physical background particles and they makes the noisy density image especially about 50 meter below from the top of the crater. In another observation, Nishiyama et al (2014) revealed the contents of background particles and the way to remove them were presented. They showed that the main contents of the background particles is low kinetic energy charged particles and also showed that it is possible to remove them by using multi-layerd muon film detector. We can plan the future muography observation to see the deeper part of the conduit( at least until 100 meter from the top of crater) by their backgroundless method. Therefore we estimated possible performance of the future observation by multi-layer muon films. The result suggests that we might get the image of shallow conduit from the surface to the depth of e.g. 55 meter with 20 meter spatial resolution or 100 meter with 27 meter resolution in case the density in the conduit is 0.0 g/cm3 and with 71 percent statistical confidence level.

  4. Robotic and Open Radical Prostatectomy: The First Prospective Randomised Controlled Trial Fuels Debate Rather than Closing the Question.

    Science.gov (United States)

    Fossati, Nicola; Wiklund, Peter; Rochat, Charles-Henry; Montorsi, Francesco; Dasgupta, Prokar; Sanchez-Salas, Rafael; Canda, Abdullah E; Piechaud, Thierry; Artibani, Walter; Mottrie, Alexandre

    2017-03-01

    Despite the finally acquired level 1 evidence, the urologic debate on open versus robotic prostatectomy still persists. This trial from Brisbane will encourage future studies that will better inform this debate and define what robotic surgery offers.

  5. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  6. A parallel group randomised open blinded evaluation of Acceptance and Commitment Therapy for depression after psychosis: Pilot trial outcomes (ADAPT).

    Science.gov (United States)

    Gumley, Andrew; White, Ross; Briggs, Andy; Ford, Ian; Barry, Sarah; Stewart, Corinna; Beedie, Sara; McTaggart, Jacqueline; Clarke, Caoimhe; MacLeod, Rachel; Lidstone, Emma; Riveros, Bruno Salgado; Young, Robin; McLeod, Hamish

    2017-05-01

    Depression is one of the major contributors to poorer quality of life amongst individuals with psychosis and schizophrenia. The study was designed as a Pilot Trial to determine the parameters of a larger, definitive pragmatic multi-centre randomised controlled trial of Acceptance and Commitment Therapy for depression after psychosis (ACTdp) for individuals with a diagnosis of schizophrenia who also meet diagnostic criteria for major depression. Participants were required to meet criteria for schizophrenia and major depression. Blinded follow-ups were undertaken at 5-months (end of treatment) and at 10-months (5-months posttreatment). Primary outcomes were depression as measured by the Calgary Depression Scale for Schizophrenia (CDSS) and the Beck Depression Inventory (BDI). A total of 29 participants were randomised to ACTdp + Standard Care (SC) (n=15) or SC alone (n=14). We did not observe significant differences between groups on the CDSS total score at 5-months (Coeff=-1.43, 95%CI -5.17, 2.32, p=0.45) or at 10-months (Coeff=1.8, 95%CI -2.10, 5.69, p=0.36). In terms of BDI, we noted a statistically significant effect in favour of ACTdp+SC at 5-months (Coeff=-8.38, 95%CI -15.49, -1.27, p=0.02) but not at 10-months (Coeff=-4.85, 95%CI -12.10, 2.39, p=0.18). We also observed significant effects on psychological flexibility at 5-months (Coeff=-8.83, 95%CI -14.94, -2.71, ptherapy with depression as the primary outcome, ACT is a promising intervention for depression in the context of psychosis. A further large-scale definitive randomised controlled trial is required to determine effectiveness. ISRCTN: 33306437. Copyright © 2016. Published by Elsevier B.V.

  7. Effectiveness of ambulatory tru-close thoracic vent for the outpatient management of pneumothorax: A prospective pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Yong Pyo; Lee, Sung Soo; Lee, Geun Dong; Joo, Seung Moon; Yum, Tae Jun; Lee, Kwang Hun [Gangnam Severance Hospital, Yonsei University Health System, Seoul (Korea, Republic of); Haam, Seok Jin [Dept. of Cardiothoracic Surgery, Ajou University Hospital, Suwon (Korea, Republic of)

    2017-06-15

    This study aimed to assess the technical feasibility, procedural safety, and long-term therapeutic efficacy of a small-sized ambulatory thoracic vent (TV) device for the treatment of pneumothorax. From November 2012 to July 2013, 18 consecutive patients (3 females, 15 males) aged 16–64 years (mean: 34.7 ± 14.9 years, median: 29 years) were enrolled prospectively. Of these, 15 patients had spontaneous pneumothorax and 3 had iatrogenic pneumothorax. A Tru-Close TV with a small-bore (11- or 13-Fr) catheter was inserted under bi-plane fluoroscopic assistance. Technical success was achieved in all patients. Complete lung re-expansion was achieved at 24 hours in 88.9% of patients (16/18 patients). All patients tolerated the procedure and no major complications occurred. The patients' mean numeric pain intensity score was 2.4 (range: 0–5) in daily life activity during the TV treatment. All patients with spontaneous pneumothorax underwent outpatient follow-up. The mean time to TV removal was 4.7 (3–13) days. Early surgical conversion rate of 16.7% (3/18 patients) occurred in 2 patients with incomplete lung expansion and 1 patient with immediate pneumothorax recurrence post-TV removal; and late surgical conversion occurred in 2 of 18 patients (11.1%). The recurrence-free long-term success rate was 72.2% (13/18 patients) during a 3-year follow-up period from November 2012 to June 2016. TV application was a simple, safe, and technically feasible procedure in an outpatient clinic, with an acceptable long-term recurrence-free rate. Thus, TV could be useful for the immediate treatment of pneumothorax.

  8. Serial plasma choline measurements after cardiac arrest in patients undergoing mild therapeutic hypothermia: a prospective observational pilot trial.

    Directory of Open Access Journals (Sweden)

    Christian Storm

    Full Text Available OBJECTIVE: Choline is related to phospholipid metabolism and is a marker for global ischaemia with a small reference range in healthy volunteers. The aim of our study was to characterize the early kinetics of plasma free choline in patients after cardiac arrest. Additionally, we investigated the potential of plasma free choline to predict neurological outcome. METHODS: Twenty patients admitted to our medical intensive care unit were included in this prospective, observational trial. All patients were enrolled between May 2010 and May 2011. They received post cardiac arrest treatment including mild therapeutic hypothermia which was initiated with a combination of cold fluid and a feedback surface cooling device according to current guidelines. Sixteen blood samples per patient were analysed for plasma free choline levels within the first week after resuscitation. Choline was detected by liquid chromatography-tandem mass spectrometry. RESULTS: Most patients showed elevated choline levels on admission (median 14.8 µmol/L; interquartile range; IQR 9.9-20.1 which subsequently decreased. 48 hours after cardiac arrest choline levels in all patients reached subnormal levels at a median of 4.0 µmol/L (IQR 3-4.9; p = 0.001. Subsequently, choline levels normalized within seven days. There was no significant difference in choline levels when groups were analyzed in relation to neurological outcome. CONCLUSIONS: Our data indicate a choline deficiency in the early postresucitation phase. This could potentially result in impaired cell membrane recovery. The detailed characterization of the early choline time course may aid in planning of choline supplementation trials. In a limited number of patients, choline was not promising as a biomarker for outcome prediction.

  9. A prospective, randomized, single - blind study comparing intraplaque injection of thiocolchicine and verapamil in Peyronie's Disease: a pilot study

    Directory of Open Access Journals (Sweden)

    I. L. Toscano Jr.

    Full Text Available ABSTRACT Objectives: To compare the response to tiocolchicine and verapamil injection in the plaque of patients with Peyronie's disease. Materials and Methods: Prospective, single-blind, randomized study, selecting patients who have presented Peyronie's disease for less than 18 months. Thiocolchicine 4mg or verapamil 5mg were given in 7 injections (once a week. Patients who had received any treatment for Peyronie's disease in the past three months were excluded. The parameters used were the International Index of Erectile Function (IIEF-5 score, analysis of the curvature on pharmaco-induced erections and size of the plaque by ultrasonography. Results: Twenty-five patients were randomized, 13 received thiocolchicine and 12 were treated with verapamil. Both groups were statistically similar. The mean curvature was 46.7° and 36.2° before and after thiocolchicine, respectively (p=0.019 and 50.4° and 42.08° before and after verapamil, respectively (p=0.012. The curvature improved in 69% of patients treated with thiocolchicine and in 66% of those who received verapamil. Regarding sexual function, there was an increase in the IIEF-5 from 16.69 to 20.85 (p=0.23 in the thiocolchicine group. In the verapamil group the IIEF-5 score dropped from 17.50 to 16.25 (p=0.58. In the thiocolchicine group, the plaque was reduced in 61% of patients. In the verapamil group, 8% presented decreased plaque size. No adverse event was associated to thiocolchicine. Conclusion: The use of thiocolchicine in Peyronie's disease demonstrated improvement on penile curvature and reduction in plaque size. Thiocolchicine presented similar results to verapamil in curvature assessment. No significant side effects were observed with the use of tiocolchicine.

  10. Sepsis prediction in critically ill patients by platelet activation markers on ICU admission: a prospective pilot study.

    Science.gov (United States)

    Layios, Nathalie; Delierneux, Céline; Hego, Alexandre; Huart, Justine; Gosset, Christian; Lecut, Christelle; Maes, Nathalie; Geurts, Pierre; Joly, Arnaud; Lancellotti, Patrizio; Albert, Adelin; Damas, Pierre; Gothot, André; Oury, Cécile

    2017-12-01

    Platelets have been involved in both immune surveillance and host defense against severe infection. To date, whether platelet phenotype or other hemostasis components could be associated with predisposition to sepsis in critical illness remains unknown. The aim of this work was to identify platelet markers that could predict sepsis occurrence in critically ill injured patients. This single-center, prospective, observational, 7-month study was based on a cohort of 99 non-infected adult patients admitted to ICUs for elective cardiac surgery, trauma, acute brain injury, and post-operative prolonged ventilation and followed up during ICU stay. Clinical characteristics and severity score (SOFA) were recorded on admission. Platelet activation markers, including fibrinogen binding to platelets, platelet membrane P-selectin expression, plasma soluble CD40L, and platelet-leukocytes aggregates were assayed by flow cytometry at admission and 48 h later, and then at the time of sepsis diagnosis (Sepsis-3 criteria) and 7 days later for sepsis patients. Hospitalization data and outcomes were also recorded. Of the 99 patients, 19 developed sepsis after a median time of 5 days. These patients had a higher SOFA score at admission; levels of fibrinogen binding to platelets (platelet-Fg) and of D-dimers were also significantly increased compared to the other patients. Levels 48 h after ICU admission no longer differed between the two patient groups. Platelet-Fg % was an independent predictor of sepsis (P = 0.0031). By ROC curve analysis, cutoff point for Platelet-Fg (AUC = 0.75) was 50%. In patients with a SOFA cutoff of 8, the risk of sepsis reached 87% when Platelet-Fg levels were above 50%. Patients with sepsis had longer ICU and hospital stays and higher death rate. Platelet-bound fibrinogen levels assayed by flow cytometry within 24 h of ICU admission help identifying critically ill patients at risk of developing sepsis.

  11. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

  12. A Prospective Longitudinal Study of U.S. Children Unable to Achieve Open-Set Speech Recognition 5 Years After Cochlear Implantation.

    Science.gov (United States)

    Barnard, Jennifer M; Fisher, Laurel M; Johnson, Karen C; Eisenberg, Laurie S; Wang, Nae-Yuh; Quittner, Alexandra L; Carson, Christine M; Niparko, John K

    2015-07-01

    To identify characteristics associated with the inability to progress to open-set speech recognition in children 5 years after cochlear implantation. Prospective, longitudinal, and multidimensional assessment of auditory development for 5 years. Six tertiary cochlear implant (CI) referral centers in the United States. Children with severe-to-profound hearing loss who underwent implantation before age 5 years enrolled in the Childhood Development after Cochlear Implantation study, categorized by level of speech recognition ability. Cochlear implantation before 5 years of age and annual assessment of emergent speech recognition skills. Progression to open-set speech recognition by 5 years after implantation. Less functional hearing before implantation, older age at onset of amplification, lower maternal sensitivity to communication needs, minority status, and complicated perinatal history were associated with the inability to obtain open-set speech recognition by 5 years. Characteristics of a subpopulation of children with CIs associated with an inability to achieve open-set speech recognition after 5 years of CI experience were investigated. These data distinguish pediatric CI recipients at risk for poor auditory development and highlight areas for future interventions to enhance support of early implantation.

  13. The Outcomes of Minimally Invasive versus Open Posterior Approach Spinal Fusion in Treatment of Lumbar Spondylolisthesis: The Current Evidence from Prospective Comparative Studies

    Science.gov (United States)

    Wu, Ai-Min; Chen, Chun-Hui; Shen, Zhi-Hao; Feng, Zhen-Hua; Weng, Wan-Qing; Li, Shu-Min; Chi, Yong-Long; Yin, Li-Hui

    2017-01-01

    Purpose. To investigate the evidence of minimally invasive (MI) versus open (OP) posterior lumbar fusion in treatment of lumbar spondylolisthesis from current prospective literatures. Methods. The electronic literature database of Pubmed, Embase, and Cochrane library was searched at April 2016. The data of operative time, estimated blood loss and length of hospital stay, visual analog scale (VAS) of both lower back pain and leg pain, Oswestry disability index (ODI), SF-36 PCS (physical component scores) and SF-36 MCS (mental component scores), complications, fusion rate, and secondary surgery were extracted and analyzed by STATA 12.0 software. Results. Five nonrandom prospective comparative studies were included in this meta-analysis. The meta-analysis showed that the MI group had a significantly longer operative time than OP group, less blood loss, and shorter hospital stay. No significant difference was found in back pain, leg pain, ODI, SF-36 PCS, SF-36 MCS, complications, fusion rate, and secondary surgery between MI and OP groups. Conclusion. The prospective evidence suggested that MI posterior fusion for spondylolisthesis had less EBL and hospital stay than OP fusion; however it took more operative time. Both MI and OP fusion had similar results in pain and functional outcomes, complication, fusion rate, and secondary surgery. PMID:28154826

  14. The Outcomes of Minimally Invasive versus Open Posterior Approach Spinal Fusion in Treatment of Lumbar Spondylolisthesis: The Current Evidence from Prospective Comparative Studies

    Directory of Open Access Journals (Sweden)

    Ai-Min Wu

    2017-01-01

    Full Text Available Purpose. To investigate the evidence of minimally invasive (MI versus open (OP posterior lumbar fusion in treatment of lumbar spondylolisthesis from current prospective literatures. Methods. The electronic literature database of Pubmed, Embase, and Cochrane library was searched at April 2016. The data of operative time, estimated blood loss and length of hospital stay, visual analog scale (VAS of both lower back pain and leg pain, Oswestry disability index (ODI, SF-36 PCS (physical component scores and SF-36 MCS (mental component scores, complications, fusion rate, and secondary surgery were extracted and analyzed by STATA 12.0 software. Results. Five nonrandom prospective comparative studies were included in this meta-analysis. The meta-analysis showed that the MI group had a significantly longer operative time than OP group, less blood loss, and shorter hospital stay. No significant difference was found in back pain, leg pain, ODI, SF-36 PCS, SF-36 MCS, complications, fusion rate, and secondary surgery between MI and OP groups. Conclusion. The prospective evidence suggested that MI posterior fusion for spondylolisthesis had less EBL and hospital stay than OP fusion; however it took more operative time. Both MI and OP fusion had similar results in pain and functional outcomes, complication, fusion rate, and secondary surgery.

  15. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

  16. (18)F Fluorocholine PET/MR Imaging in Patients with Primary Hyperparathyroidism and Inconclusive Conventional Imaging: A Prospective Pilot Study.

    Science.gov (United States)

    Kluijfhout, Wouter P; Pasternak, Jesse D; Gosnell, Jessica E; Shen, Wen T; Duh, Quan-Yang; Vriens, Menno R; de Keizer, Bart; Hope, Thomas A; Glastonbury, Christine M; Pampaloni, Miguel H; Suh, Insoo

    2017-01-25

    Purpose To investigate the performance of flourine 18 ((18)F) fluorocholine (FCH) positron emission tomography (PET)/magnetic resonance (MR) imaging in patients with hyperparathyroidism and nonlocalized disease who have negative or inconclusive results at ultrasonography (US) and technetium 99m ((99m)Tc) sestamibi scintigraphy. Materials and Methods This study was approved by the institutional review board. Between May and December 2015, 10 patients (mean age, 70.4 years; range, 58-82 years) with biochemical primary hyperparathyroidism and inconclusive results at US and (99m)Tc sestamibi scintigraphy were prospectively enrolled. All patients gave informed consent. Directly after administration of 3 MBq/kg of FCH, PET imaging was performed, followed by T1- and T2-weighted MR imaging before and after gadolinium enhancement. Intraoperative localization and histologic results were the reference standard for calculating sensitivity and positive predictive value. The Wilcoxon rank test was used to calculate the mean difference in maximum standardized uptake value (SUVmax) between abnormal parathyroid uptake and physiologic thyroid uptake. The Wilcoxon rank-sum test was performed. Results MR imaging alone showed true-positive lesions in five patients and a false-positive lesion in one patient. FCH PET/MR imaging allowed correct localization of nine of 10 adenomas (90% sensitivity), without any false-positive results (100% positive predictive value). One patient had four-gland hyperplasia, of which three hyperplastic glands were not localized. The median SUVmax of the nine preoperatively identified adenomas was 4.9 (interquartile range, 2.45-7.35), which was significantly higher than the SUV, 2.7 (interquartile range, 1.6-3.8), of the thyroid (P = .008). Conclusion FCH PET/MR imaging allowed localization of adenomas with high accuracy when conventional imaging results were inconclusive and provided detailed anatomic information. More patients must be examined to confirm

  17. Rifaximin Is Effective for the Treatment of Clostridium difficile—Associated Diarrhea: Results of an Open-Label Pilot Study

    Directory of Open Access Journals (Sweden)

    David T. Rubin

    2011-01-01

    Full Text Available Objectives. This open-label trial assessed the efficacy and safety of rifaximin as first-line therapy in hospitalized patients with Clostridium difficile-associated diarrhea (CDAD. Methods. We enrolled thirteen patients who had a confirmed diagnosis of CDAD characterized by ≥3 unformed stools/day and positive C. difficile toxin assay. Those patients received rifaximin 400 mg three times daily for 10 days. Resolution of symptoms, repeat assay 10 days after treatment, and followup for recurrence were assessed. Results. Eight patients completed the study, and all reported symptom resolution during treatment. Mean time to last unformed stool was 132 h ± 42.5 h. Seven patients had no relapse by week 2 and in longer followup (median 162 days. One patient had recurrent CDAD during a repeat hospitalization. Conclusions. Rifaximin was effective and safe as first-line treatment for CDAD and did not result in recurrence in most patients.

  18. Maximum mouth opening and trismus in 143 patients treated for oral cancer: a 1-year prospective study.

    Science.gov (United States)

    Wetzels, Jan-Willem G H; Merkx, Matthias A W; de Haan, Anton F J; Koole, Ron; Speksnijder, Caroline M

    2014-12-01

    Patients with oral cancer can develop restricted mouth opening (trismus) because of the oncologic treatment. Maximum mouth opening (MMO) was measured in 143 patients shortly before treatment and 0, 6, and 12 months posttreatment, and the results were analyzed using a linear mixed-effects model. In every patient, MMO decreased after treatment. The patients who underwent surgery, recovered partially by 6 and 12 months after treatment, whereas the patients who received both surgery and radiotherapy or primary radiotherapy did not recover. Tumor location, tumor size, and alcohol consumption had independent effects on MMO. Having trismus (MMO trismus after oral cancer treatment. © 2014 Wiley Periodicals, Inc.

  19. The volume and pH of residual pharyngeal fluid aspirated from the TaperGuard Evac™ Endotracheal Tube following elective surgery: a prospective pilot study.

    Science.gov (United States)

    Schumann, R; Gandhi, P; Switkowski, K; Grant, M A B; Bonney, I

    2013-03-01

    Oropharyngeal suctioning prior to extubation aims to minimize postextubation tracheal soiling from remaining fluid. We investigated the amount and nature of any fluid remaining after such suctioning and contributing factors. ASA I - III patients undergoing elective surgery under general anesthesia with endotracheal intubation participated in this prospective observational pilot study. Following oropharyngeal suctioning immediately prior to extubation, a dedicated port of the endotracheal tube (TaperGuard Evac™ Endotracheal Tube) was aspirated. The amount and pH of residual fluid was recorded. Data collection included age, sex, body mass index, comorbidities, ASA status, procedure type and duration. The Chi-Square, Wilcoxon Rank-Sum, t-tests, and univariate regression analysis were used as appropriate. Ninety-eight patients completed the study. The mean aspirated volume in 38 (38.8%) patients was 0.9 ± 1.3 mL and sixty patients (61.2%) had no aspirate. A body mass index of ≥ 30 kg/m2 was associated with the presence of fluid (P=0.03), and a higher volume (P=0.03). The fluid pH was 7 ± 0.81 (mean ± SD). A duration of surgery ≥ 120 minutes predicted a lower pH. The prevalence and amount of residual fluid after oropharyngeal suctioning was low and likely clinically insignificant. A higher body mass index was associated with a higher incidence and volume of residual fluid. Longer procedure duration determined a slightly lower pH, with a mildly acidic pH range. The possibility of a lower fluid pH after prolonged surgery contributing to postoperative sore throat via mucosal irritation warrants investigation.

  20. Effects of radiotherapy for brain metastases on quality of life (QoL). Prospective pilot study of the DEGRO QoL working party

    Energy Technology Data Exchange (ETDEWEB)

    Steinmann, Diana; Bruns, Frank [Medical School, Hannover (Germany). Radiation Oncology; Schaefer, Christof; Hipp, Matthias [Regensburg Univ. (Germany). Radiation Oncology; Oorschot, Birgitt van [Wuerzburg Univ. (Germany). Radiation Oncology; Wypior, Hans-Joachim [Hospital Landshut (Germany). Radiation Oncology; Boelling, Tobias [Muenster Univ. (Germany). Radiation Oncology; Sehlen, Susanne [Ludwig Maximilians Univ., Muenchen (Germany). Radiation Oncology; Hagg, Juliane [Ulm Univ. (Germany). Radiation Oncology; Bayerl, Anja [Hospital Krems (Austria). Radiation Oncology; Geinitz, Hans [Technical Univ. Muenchen (Germany). Radiation Oncology; Vordermark, Dirk [Halle-Wittenberg Univ., Halle (Germany). Radiation Oncology

    2009-03-15

    Background: Prospective data on quality-of-life (QoL) effects of radiotherapy for brain metastases are currently lacking, but would be of great interest to guide therapeutic decisions. Patients and Methods: From 01/2007 to 08/2007, 46 patients with previously untreated brain metastases were recruited at eight centers. QoL was measured at start of treatment (T{sub 0}) and at 3 months ({sub T3mo}). In the pilot study, two combinations of QoL instruments could be used at the discretion of the centers (A: EORTC QLQ-C30 and B: EORTC QLQ-C15-PAL both with brain module BN20, assessment by proxies with A: Palliative Care Outcome Scale, B: self-constructed brain-specific instrument). Results: All patients received whole-brain radiotherapy, four with an additional boost irradiation. At T{sub 3mo}, 26/46 patients (56.5%) had died. 17/20 survivors (85%) completed the questionnaires. In 3-month survivors, QoL deteriorated in most domains, significant in drowsiness, hair loss and weakness of legs. The scores for headaches and seizures were slightly better after 3 months. Assessment by proxies also suggested worsening of QoL. Initial QoL at T{sub 0} was better in those alive than in those deceased at T{sub 3mo}, significant for physical function and for the symptom scales of fatigue and pain, motor dysfunction, communication deficit and weakness of legs. Conclusion: Practicability and compliance appeared better with the (shorter) version B. This version is now used in the ongoing main phase of the study with additional centers. First results indicate a moderate worsening of QoL during the first 3 months after start of palliative radiotherapy for brain metastases. QoL at initiation of radiotherapy may be prognostic for survival. (orig.)

  1. Ultrasound to Detect Pressure-related Deep Tissue Injuries in Adults Admitted via the Emergency Department: A Prospective, Descriptive, Pilot Study.

    Science.gov (United States)

    Scheiner, Jonathan; Farid, Karen; Raden, Mark; Demisse, Seleshi

    2017-03-01

    Stage 4 pressure ulcers (PUs) start with tissue death at the level of the bone, also known as deep tissue injury (DTI). Studies have shown the appearance of DTI on the skin is delayed for several days after the original pressure-related injury to the deep soft tissues. Studies also suggest DTI can be seen using ultrasound (US) technology. A prospective, descriptive, correlational pilot study was conducted to evaluate the use of US technology to detect DTI in the soft tissues that are not visible on the skin upon hospital admission. Study participants included a convenience sample of 33 persons at risk for PUs (ie, Braden score study. US scans identified pressure necrosis at 2 levels: bone (54 positive [US+]) and subcutaneous (SC); 79 US+, respectively). US+ bone sites resulted in 5 PUs appearing 6 to 7 days post-admission (sensitivity = 100%, specificity 84.7%, positive predictive value 10%, and negative predictive value 100%), indicating all DTI that later became purple skin DTI were detected by the US. US+ SC sites, located immediately under the skin, yielded 5 PUs appearing on day 2 after admission (sensitivity 100%, specificity 74.8%, positive predictive value 6.3%, and negative predictive value 100%). The participants with PU occurrence in both bone and SC groups had low Braden scores (bone group mean = 13.25, SC group mean = 11.2). Study patients who were positive for PU also had >4 SFRFs. Creatinine phosphokinase, calcium, and myoglobin levels were inconsistent and did not correlate with US+ scans. These observations warrant larger studies to confirm findings and optimize the validity of US screening for DTI in select populations, which may help improve protocols of care and PU admission documentation. The preliminary results suggest inclusion of the Braden Scale score and known PU risk factors may improve the positive predictive value of this test.

  2. The use of school teachers to promote oral hygiene in some secondary school students at Hyderabad, Andhra Pradesh, India: A short term prospective pilot study

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    Byalakere R Chandrashekar

    2012-01-01

    Full Text Available Study design : It was a short term prospective pilot study on a group of 116 secondary school students. Objectives: To assess the feasibility of using the services of school teachers to promote oral hygiene in secondary school students and compare the effectiveness of dental health education (DHE offered by school teachers on a fortnightly basis with what is offered by dental professionals at three- monthly intervals. Materials and Methods: Six secondary schools were randomly selected. The base-line Oral Hygiene Index simplified (OHI-S and Plaque index (PI scores for all the students were recorded. The teachers were trained on dental health facts. The six schools were divided into three groups of two schools with different intervention techniques: Group 1- Schools given no health education, Group 2 - Schools given health education by their school teachers on a fortnightly basis together with simple screening for deposits of gross calculus , Group 3 - Schools which were given health education by dental professionals at intervals of three months without any screening. Grade nine students were selected for pre and post intervention evaluation. The second examination was done six months following the intervention to find out the OHI-S and Plaque index scores. The examination was done by three trained and calibrated dentists. Data analysis was done with SPSS 16 with relevant statistical tests. Results: The mean OHI-S and PI scores were significantly less in group 2 and there was a statistically significant difference between the baseline OHI - S, PI score and the scores after six months in all the three groups. Conclusion: The concept of utilizing the teachers for frequent DHE and screening for any gross deposits of food debris and calculus is feasible. Also frequent DHE by teachers was more effective than the infrequent DHE by the professionals.

  3. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

    Directory of Open Access Journals (Sweden)

    Francesca Lombardi

    Full Text Available Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13 versus the 23-valent polysaccharide vaccine (PPSV23 in HIV-infected adults.We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50 received two doses of PCV13 eight weeks apart, and group 2 (n = 50 received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100 were also enrolled as baseline controls.Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group.In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated.ClinicalTrials.gov NCT02123433.

  4. The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial

    Science.gov (United States)

    Tsunoda, Tetsuji; Yamada, Masayo; Akiyama, Tomoaki; Minami, Taichi; Yoshii, Taishi; Kondo, Yoshinobu; Satoh, Shinobu; Terauchi, Yasuo

    2016-01-01

    Background Insomnia is associated with the onset and development of diabetes. Melatonin affects sleep quality and glucose metabolism in diabetic patients with insomnia. We administered ramelteon, an agonist of melatonin, to type 2 diabetic patients and investigated its effects on glucose metabolism and insomnia. Methods This multicenter, prospective, randomized, and observational pilot study was performed between April 2014 and April 2015 at three institutes in Japan. Patients were prescribed ramelteon 8 mg/day for 3 months (first period). And patients were divided at random into the continuation group that continued taking ramelteon and the discontinuation group that discontinued taking ramelteon for 3 additional months (second period). The primary endpoint was change in glycated hemoglobin (HbA1c) level. Secondary endpoints were changes in global Pittsburgh sleep questionnaire index (PSQI) score and other glucose metabolism makers. Results We enrolled 42 patients, and 32 patients completed the first period. Their mean HbA1c was 6.7%, and global PSQI score was 8.1 on average. HbA1c level did not change but global PSQI score improved from 8.1 to 7.2 by ramelteon (P = 0.030). Thirty-one patients completed the second period. HbA1c level did not change in the continuation group, but it increased from 6.7% to 6.9% (P = 0.003) in the discontinuation group. Global PSQI score did not change in each group. There was no rebound insomnia. Conclusion Treatment with ramelteon did not change the HbA1c level but improved sleep quality in type 2 diabetic patients with insomnia. Discontinuation of ramelteon slightly increased the HbA1c level and did not worsen sleep quality. PMID:27829954

  5. Efficacy and safety of atorvastatin in South Asian patients with dyslipidemia: an open label noncomparative pilot study

    Directory of Open Access Journals (Sweden)

    Jeetesh V Patel

    2005-12-01

    Full Text Available Jeetesh V Patel1, Sandeep Gupta2, Frank Lie3, Elizabeth A Hughes11Sandwell and West Birmingham Hospitals NHS Trust, West Bromwich, UK; 2Whipps Cross and St Bartholomew’s Hospitals; and 3Whipps Cross University Hospital, London, UKBackground: Rates of coronary heart disease (CHD mortality are 40% higher amongst South Asian men and women living in the UK compared with the general UK population. Despite an established excess CHD risk, little is known of the efficacy and safety of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA reductase inhibitors (statins amongst South Asian migrants.Methods and results: Hyperlipidemic South Asian patients (raised or uncontrolled lowdensity lipoprotein cholesterol [LDL-C] were recruited from two UK centers (n = 33. After a five-week period, which included dietary advice, patients received atorvastatin 10 mg/d for five weeks to achieve a target LDL-C goal of < 3.0 mmol/L, titrated to 20 mg, 40 mg, or 80 mg for a further 12 weeks as required. Significant reductions in LDL-C levels from baseline were observed after 4 weeks’ and 17 weeks’ treatment with atorvastatin (≥ 33.6%; 26.0, 41.2. Overall, 81% (95% confidence interval [CI]: 62.5, 92.6% achieved the target LDL-C after 4 weeks’ treatment with 10 mg atorvastatin. Titration to a dose of more than 20 mg was required in only one patient (40 mg at any point during the study. Nineteen patients reported at least one adverse event during the study; the majority were mild in severity and considered unrelated to atorvastatin.Conclusions: Atorvastatin was effective in achieving target lipid levels and was well tolerated. Statin therapy for high-risk South Asian individuals is likely to benefit CHD outcomes, although further and larger prospective trials are required.Keywords: hyperlipidemia, lipids, cholesterol, dyslipidemia, statins, coronary heart disease, South Asians

  6. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study.

    Science.gov (United States)

    Naik, Aanand D; White, Craig D; Robertson, Suzanne M; Armento, Maria E A; Lawrence, Briana; Stelljes, Linda A; Cully, Jeffrey A

    2012-07-24

    Patients with diabetes are at increased risk for depression, compounding the burden of disease. When comorbid with diabetes, depression leads to poorer health outcomes and often complicates diabetes self-management. Unfortunately, treatment options for these complex patients are limited and comprehensive services are rarely available for patients in rural settings. A small open trial was conducted to test the acceptability, feasibility and preliminary outcomes of a telephone-delivered coaching intervention for rural-dwelling older adults with uncontrolled diabetes and comorbid, clinically significant depressive symptoms. A total of eight older adults were enrolled in Healthy Outcomes through Patient Empowerment (HOPE), a 10-session (12-week), telephone-based coaching intervention. Primary study constructs included measures of diabetes control (Hemoglobin [Hb] A1c), depressive symptoms (Patient Health Questionnaire-9 [PHQ-9]), and diabetes-related distress (Problem Areas in Diabetes Scale [PAID]). Assessments were conducted at baseline, post-intervention, and 6-month follow-up. Acceptability and feasibility were evaluated using patient surveys, focused exit interviews, and session attendance data. Clinically significant improvements were realized post-intervention and at 6-month follow-up for outcomes related to diabetes and depression. Effect sizes using Cohen's d were determined post-intervention and at 6-month follow-up, respectively, for HbA1c (d=0.36; d=0.28), PHQ-9 (d=1.48; d=1.67, and PAID (d=1.50; d=1.06) scores. Among study participants, HbA1c improved from baseline by a mean (M) of 1.13 (SD=1.70) post-intervention and M=0.84 (SD=1.62) at 6 months. Depression scores, measured by the PHQ-9, improved from baseline by M=5.14 (SD=2.27) post-intervention and M=7.03 (SD=4.43) at 6-month follow-up. PAID scores also improved by M=17.68 (SD=10.7) post-intervention and M=20.42 (SD=20.66) from baseline to 6-month follow-up. Case examples are provided for additional

  7. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure

    Directory of Open Access Journals (Sweden)

    Anant Kumar

    2001-01-01

    Conclusion: In view of the better clearance rate and lesser cost of treatment, open surgery still has a place in the management of staghorn stones with chronic renal failure even in a tertiary urological center. However postoperative pain and a larger scar cannot be ignored.

  8. Group acceptance and commitment therapy (ACT) for bipolar disorder and co-existing anxiety - an open pilot study.

    Science.gov (United States)

    Pankowski, Sara; Adler, Mats; Andersson, Gerhard; Lindefors, Nils; Svanborg, Cecilia

    2017-03-01

    Previous studies have supported acceptance and commitment therapy (ACT) for reducing impairment related to various chronic conditions. ACT may possibly be beneficial for bipolar disorder (BD) with co-existing anxiety, which is associated with a poorer treatment outcome. Efforts are needed to identify suitable psychological interventions for BD and co-existing anxiety. In this open clinical trial, we included 26 patients with BD type 1 or 2 at an outpatient psychiatric unit specializing in affective disorders. The intervention consisted of a 12-session manualized group treatment that included psychoeducation, mindfulness, engaging in values-based behaviour, cognitive defusion, acceptance and relapse prevention modules. Participants completed four self-report questionnaires covering anxiety symptoms (Beck Anxiety Inventory - BAI), depressive symptoms (Beck Depression Inventory - BDI-II), quality of life (Quality of Life Inventory - QOLI) and psychological flexibility (Acceptance and Action Questionnaire - AAQ-2) before, during and after the treatment. At post-treatment, the participants reported significant improvements in all outcome measures, with large effects (Cohen's d between 0.73 and 1.98). The mean reduction in anxiety symptoms was 45%. At post-treatment, 96% of the patients were classified as responders on at least one of the outcome measures. A limitation is that the trial is uncontrolled. The results suggest that ACT has the potential to be an effective treatment for BD patients with co-existing anxiety. Further randomized studies are warranted.

  9. [TNF-alfa (-857C/T) polymorphism in open angle glaucoma in Romania -- results of a pilot study].

    Science.gov (United States)

    Simionescu, Ruxandra; Voinea, Liliana; Cornăţeanu, Roxana Sfrenţ

    2013-01-01

    Primary open angle glaucoma is a progressive optic neuropathy with multiple causative factors including genetic immune disregulation. TNF-alfa has pro-apoptotic effects on the retinal ganglion cells, thus being directly involved in the neurodegeneration of the optic nerve head. Our purpose was to investigate the influence on susceptibility and/or clinical and characteristics of TNF-alfa promoter polymorphism -857 C/T in Romanian patients diagnosed with POAG. We assessed 159 Romanian subjects, 61 diagnosed with glaucoma (F/M 39/22) and 98 healthy unrelated matched controls-HC for the polymorphism -857 C/T, genotyped by Real Time PCR (Taqman SNP Genotyping Assay C_2215707_10, Applied Biosystems, USA). The diagnosis and the staging of the disease in the POAG group were assessed using the current guidelines. Association tests for the SNP were performed using SPSS 11.2 (Fisher test) and p values < or = 0.05 were considered significant. The Hardy-Weinberg equilibrium assessed using Chi-square test was respected in both studied groups- POAG and HC (p = 0.000009 and respectively p = 0.04771). There was no association found between the frequencies of alleles between studied groups (CC/CT/TT= 0.81/0.09/0.08 respectively 0.70/0.23/0.06). TNF-alfa promoter polymorphism -857 C/T doesn't seem to influence the susceptibility to POAG and the results should be confirmed on larger cohorts.

  10. Micronutrients supplementation and nutritional status in cognitively impaired elderly persons: a two-month open label pilot study.

    Science.gov (United States)

    von Arnim, Christine A F; Dismar, Stephanie; Ott-Renzer, Cornelia S; Noeth, Nathalie; Ludolph, Albert C; Biesalski, Hans K

    2013-11-15

    Malnutrition is a widespread problem in elderly people and is associated with cognitive decline. However, interventional studies have produced ambiguous results. For this reason, we wanted to determine the effect of micronutrient supplementation on blood and tissue levels and on general nutritional status in persons with mild or moderate cognitive impairment. We performed a 2-month, open-label trial, administering a daily micronutrient supplement to 42 memory clinic patients with mild cognitive deficits. Blood levels of antioxidants, zinc, and B vitamins were determined before and after supplementation. In addition, we assessed metabolic markers for B vitamins and intracellular (buccal mucosa cell [BMC]) antioxidant levels. Nutritional status was assessed by using the Mini Nutritional Assessment (MNA). Blood levels of B vitamins, folic acid, lutein, β-carotene, α-carotene, and α-tocopherol increased significantly. Decreases in homocysteine levels and the thiamine pyrophosphate effect and an increase in holotranscobalamin were observed. We found no increase in intracellular antioxidant levels of BMC. The MNA score in subjects at risk for malnutrition increased significantly, mainly owing to better perception of nutritional and overall health status. Micronutrient supplementation improved serum micronutrient status, with improved metabolic markers for B vitamins but not for intracellular antioxidant status, and was associated with improved self-perception of general health status. Our data underline the necessity of determining micronutrient status and support the use of additional assessments for general health and quality of life in nutritional supplementation trials.

  11. Effect of topical vitamin D on chronic kidney disease-associated pruritus: An open-label pilot study.

    Science.gov (United States)

    Jung, Kyung Eun; Woo, Yu Ri; Lee, Joong Sun; Shin, Jong Ho; Jeong, Jin Uk; Koo, Dae Won; Bang, Ki Tae

    2015-08-01

    Chronic kidney disease-associated pruritus (CKD-aP) is a troublesome symptom in patients with end-stage renal disease (ESRD). Recently, vitamin D deficiency has been known to be one of the possible etiologic factors in CKD-aP. However, limited data is available on whether topical vitamin D treatment is effective for relieving CKD-aP. Therefore, the purpose of this study is to evaluate the effectiveness of topically vitamin D for CKD-aP. Twenty-three patients with CKD-aP were enrolled in a single center, open-label study. Patients were instructed to apply a topical vitamin D (calcipotriol) agent (Daivonex solution; LEO Pharma) or vehicle solution twice daily for a month. We assessed the efficacy and safety of topical vitamin D on CKD-aP using clinical and dermoscopic photographs, and questionnaires including the validated modified pruritus assessment score (VMPAS) and visual analog scale (VAS) every 2 weeks. Dry dermoscopic findings showed significant improvement of scale (dryness) on the skin of topical vitamin D-treated patients compared with those of the vehicle group. Both VMPAS and VAS were significantly decreased after 2 and 4 weeks of the topical vitamin D treatment compared with the vehicle, respectively (P < 0.05). No significant side-effects were observed. Topical vitamin D may be one of the safe and effective therapeutic candidates for CKD-aP.

  12. The effects of orally administered Beta-glucan on innate immune responses in humans, a randomized open-label intervention pilot-study.

    Directory of Open Access Journals (Sweden)

    Jenneke Leentjens

    Full Text Available RATIONALE: To prevent or combat infection, increasing the effectiveness of the immune response is highly desirable, especially in case of compromised immune system function. However, immunostimulatory therapies are scarce, expensive, and often have unwanted side-effects. β-glucans have been shown to exert immunostimulatory effects in vitro and in vivo in experimental animal models. Oral β-glucan is inexpensive and well-tolerated, and therefore may represent a promising immunostimulatory compound for human use. METHODS: We performed a randomized open-label intervention pilot-study in 15 healthy male volunteers. Subjects were randomized to either the β -glucan (n = 10 or the control group (n = 5. Subjects in the β-glucan group ingested β-glucan 1000 mg once daily for 7 days. Blood was sampled at various time-points to determine β-glucan serum levels, perform ex vivo stimulation of leukocytes, and analyze microbicidal activity. RESULTS: β-glucan was barely detectable in serum of volunteers at all time-points. Furthermore, neither cytokine production nor microbicidal activity of leukocytes were affected by orally administered β-glucan. CONCLUSION: The present study does not support the use of oral β-glucan to enhance innate immune responses in humans. TRIAL REGISTRATION: ClinicalTrials.gov NCT01727895.

  13. Prospective, noncomparative, nonrandomized case study of short-term outcomes of 360° suture trabeculotomy ab interno in patients with open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Sato T

    2015-01-01

    Full Text Available Tomoki Sato,1 Akira Hirata,2 Takanori Mizoguchi31Sato Eye Clinic, Arao City, Kumamoto, 2Hayashi Eye Hospital, Fukuoka, 3Mizoguchi Eye Clinic, Nagasaki, JapanBackground: In this paper, we describe 360° suture trabeculotomy (360°LOT ab interno and the short-term course in patients who underwent this procedure.Methods: We prospectively studied 12 patients (12 eyes with open-angle glaucoma who underwent 360°LOT ab interno at the Sato Eye Clinic between February and July 2014. The surgical procedure involved making a 1.7 mm temporal corneal incision, exposing an approximately 15° opening in the inner wall of Schlemm’s canal (nasal side using a Trabectome with a gonioscope, and inserting a 5-0 nylon suture rounded at the tip into Schlemm’s canal opened via the anterior chamber. The suture was then threaded around Schlemm’s canal, and the tip of the suture that emerged on the other side was then advanced through the opening to make a circumferential incision. Intraocular pressure (IOP, number of anti-glaucoma medications used, complications, and the surgery completion rate were prospectively studied.Results: Mean IOP, which was 19.4 mmHg at baseline, showed a significant decrease at each of the monthly observation points, reaching 13.8 mmHg at 6 months after surgery (P=0.0004, paired t-test. The mean number of anti-glaucoma medications decreased from 3.2 at baseline to 1.1 at 6 months after surgery. IOP spikes ≥30 mmHg were seen in 25% of patients, but there were no other serious complications and the surgery completion rate was 92%.Conclusion: The 360°LOT ab interno procedure preserves the conjunctiva and sclera, and has a high surgery completion rate when using the anterior chamber approach, and could therefore be an effective short-term treatment of open-angle glaucoma.Keywords: non-penetrating surgery, intraocular pressure, Schlemm’s canal, corneal incision, Trabectome

  14. Behavioral health coaching for rural-living older adults with diabetes and depression: an open pilot of the HOPE Study

    Directory of Open Access Journals (Sweden)

    Naik Aanand D

    2012-07-01

    Full Text Available Abstract Background Patients with diabetes are at increased risk for depression, compounding the burden of disease. When comorbid with diabetes, depression leads to poorer health outcomes and often complicates diabetes self-management. Unfortunately, treatment options for these complex patients are limited and comprehensive services are rarely available for patients in rural settings. Methods A small open trial was conducted to test the acceptability, feasibility and preliminary outcomes of a telephone-delivered coaching intervention for rural-dwelling older adults with uncontrolled diabetes and comorbid, clinically significant depressive symptoms. A total of eight older adults were enrolled in Healthy Outcomes through Patient Empowerment (HOPE, a 10-session (12-week, telephone-based coaching intervention. Primary study constructs included measures of diabetes control (Hemoglobin [Hb] A1c, depressive symptoms (Patient Health Questionnaire-9 [PHQ-9], and diabetes-related distress (Problem Areas in Diabetes Scale [PAID]. Assessments were conducted at baseline, post-intervention, and 6-month follow-up. Acceptability and feasibility were evaluated using patient surveys, focused exit interviews, and session attendance data. Results Clinically significant improvements were realized post-intervention and at 6-month follow-up for outcomes related to diabetes and depression. Effect sizes using Cohen's d were determined post-intervention and at 6-month follow-up, respectively, for HbA1c (d=0.36; d=0.28, PHQ-9 (d=1.48; d=1.67, and PAID (d=1.50; d=1.06 scores. Among study participants, HbA1c improved from baseline by a mean (M of 1.13 (SD=1.70 post-intervention and M=0.84 (SD=1.62 at 6 months. Depression scores, measured by the PHQ-9, improved from baseline by M=5.14 (SD=2.27 post-intervention and M=7.03 (SD=4.43 at 6-month follow-up. PAID scores also improved by M=17.68 (SD=10.7 post-intervention and M=20.42 (SD=20.66 from baseline to 6-month follow

  15. Improvement of functional constipation with kiwifruit intake in a Mediterranean patient population: An open, non-randomized pilot study

    Directory of Open Access Journals (Sweden)

    Oriol Cunillera

    2015-07-01

    Full Text Available Introduction: Kiwifruit consumption has shown to improve functional constipation in healthy elderly population, according to studies in New Zealand and China. The aim of this study was to evaluate the effect of kiwifruit intake on functional constipation in a Mediterranean patient population characterized by its distinctive nutritional habits.Material and Methods: An open, non-controlled and non-randomized longitudinal study was conducted in 46 patients with constipation (Rome III criteria. Patients monitored for five weeks: weeks 1 and 2 no kiwifruit and weeks 3-5 three kiwifruit per day (Green kiwifruit, Actinidia deliciosa var Hayward. Bristol Scale, volume of stools, and ease of defecation was self- reported daily. The evolution of the categorical variables was tested using the Bhapkar test; functional data methodology was used for continuous variables, and Generalized Estimating Equation (GEE models were adjusted.Results: The percentage of patients with ≥3 stools per week increased from 82.61% (95% CI: 69–91.2 at week 1 to 97.78% (95% CI: 87.4–99.9 at week 2 of kiwifruit intake, with 76.09% (95% CI: 61.9–86.2 responding during the first week. The reporting of stable ideal stools increased from 17.39% (95% CI: 8.8–31 at week 2 to 33.33% (95% CI: 21.3–48 at week 5. According to GEE models, the number of depositions increased significantly (p-values<0.001 in 0.398 daily units at week 1 the first week of intake, up to 0.593 daily units at week 5; significant improvements on facility in evacuation and volume of evacuation were found from the firstweek of intake (all p-values<0.001.Conclusions: The intake of three kiwifruits per day significantly improves the quality of evacuation (number of depositions, volume, consistency and ease in a Mediterranean patient population suffering from functional constipation.

  16. An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas

    DEFF Research Database (Denmark)

    Zawadzki, Antoni; Johnson, Louis Banka; Bohe, Måns;

    2017-01-01

    PURPOSE: It has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal...... fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn's disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal...... fistulas without any concomitant medication. METHODS: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 ( ClinicalTrial.gov identifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted...

  17. An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas

    DEFF Research Database (Denmark)

    Zawadzki, Antoni; Johnson, Louis Banka; Bohe, Måns

    2017-01-01

    PURPOSE: It has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal...... fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn's disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal...... fistulas without any concomitant medication. METHODS: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 ( ClinicalTrial.gov identifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted...

  18. Endotracheal tube tip culture in post-operative respiratory infections in open heart surgery patients: a one year prospective study

    Directory of Open Access Journals (Sweden)

    Chandra Mouli HC

    2016-10-01

    Full Text Available Background: Respiratory tract infections are a common occurrence after open heart surgery, leading to prolonged hospital stay, morbidity and costing the hospital exchequer. This study was conducted to study the utility of postextubation endotracheal tube [ET] tip culture in providing an early-basis for starting evidence-based antibiotic therapy. Methods: We retrospectively reviewed the case records of 172 patients who had undergone heart surgery at our tertiary care teaching hospital for occurrence of post-operative infections from clinical and microbiological data. Results: Bacterial culture was positive in 67(39% patients. Endotracheal tube patients, grew organisms that were sensitive to empirical antibiotic therapy, in 39 (58% patients. In 28 (42% patients organisms resistant to empirical therapy were grown; only 14 of the 28 patients (50% were symptomatic. Staphylococcus was the most common organism isolated followed by Acinetobacter and Enterobacter. Pseudomonas aeruginosa isolates were sensitive to all the antibiotics tested. Resistance was high among Acinetobacter sp. All the Gram-negative bacteria were sensitive to tigecycline. Resistance for beta-lactam antibiotics ranged from 35%-66% with imipenem being the most effective antibiotic. Conclusion: Our observations provide useful information regarding the microbiology of respiratory infection occurring in post-operative patients who had undergone open-heart surgery. Post-extubation endotracheal tip culture appears to be a useful tool for reliable and accurate diagnosis and treatment of these infections.

  19. AUGMENTATION VS NONAUGMENTATION TECHNIQUES FOR OPEN REPAIRS OF ACHILLES TENDON RUPTURES WITH EARLY FUNCTIONAL TREATMENT: A PROSPECTIVE RANDOMIZED STUDY

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    Gündüz Tezeren

    2006-12-01

    Full Text Available A prospective randomized study was conducted in order to compare augmentation technique versus nonaugmentation technique, followed by early functional postoperative treatment, for operative repair of Achilles tendon ruptures. Twenty-four consecutive patients were assigned to two groups. Group I included 12 patients treated with Lindholm augmentation technique, whereas group II included 12 patients treated with modified Kessler end-to-end repair. Thereafter, these patients had postoperative management with a below-knee-cast for three weeks. The physioteraphy was initiated immediately after the cast was removed. Full weight bearing was allowed after five weeks postoperatively in the both groups. Two patients had reruptures in group II, whereas group I had prolonged operative time significantly. The patients with reruptures underwent reoperations and at the most final follow-up, it was observed that they could not resume to sporting activities. The other objective and subjective results were similar between two groups. Because of quite high rerupture rate in the group of patients treated with nonaugmentation technique, we favor functional postoperative treatment with early ankle movement in the patients treated with augmentation technique for the management of acute rupture of the Achilles tendon

  20. Efficacy, safety and tolerability of escitalopram in doses up to 50 mg in Major Depressive Disorder (MDD: an open-label, pilot study

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    Crawford Gordon M

    2011-03-01

    Full Text Available Abstract Background Escitalopram is licensed for use at doses up to 20 mg but is used clinically at higher doses. There is limited published data at higher doses and none in the treatment of Major Depressive Disorder (MDD. Methods This open-label, pilot study was designed to investigate the efficacy, safety and tolerability of escitalopram in doses up to 50 mg in MDD. It was conducted in 60 primary care patients with MDD who had not responded to adequate treatment with citalopram. Patients were treated with escalating doses of escitalopram up to 50 mg for up to 32 weeks until they achieved remission (Montgomery-Asberg Depression Rating Scale [MADRS] ≤8 or failed to tolerate the dose. Results Forty-two patients (70% completed the study. Twenty-one patients (35% achieved remission with 8 of the 21 patients (38% needing the 50 mg dose to achieve remission. Median time to remission was 24 weeks and median dose in remission was 30 mg. No significant safety issues were identified although tolerability appeared to decline above a dose of 40 mg with 26% of patients unable to tolerate 50 mg. Twelve (20% patients had adverse events leading to discontinuation. The most common adverse events were headache (35%, nausea, diarrhoea and nasopharyngitis (all 25%. Minor mean weight gain was found during the study, which did not appear to be dose-related. Half of the patients who completed the study chose to continue treatment with escitalopram rather than taper down the dose at 32 weeks. Conclusions Dose escalation with escitalopram above 20 mg may have a useful role in the management of patients with MDD, although further studies are needed to confirm this finding. Trial Registration ClinicalTrials.gov: NCT00785434

  1. Development and Open Pilot Trial of an HIV-Prevention Intervention Integrating Mobile-Phone Technology for Male Sex Workers in Chennai, India.

    Science.gov (United States)

    Thomas, Beena; Closson, Elizabeth F; Biello, Katie; Menon, Sunil; Navakodi, Pandiaraja; Dhanalakshmi, A; Mayer, Kenneth H; Safren, Steven A; Mimiaga, Matthew J

    2015-12-29

    In India men who have sex with men and engage in sex work (i.e., male sex workers; MSW) have a high risk of transmitting HIV. Globally, sex workers have become more spatially mobile due to advances in mobile-phone technology. In 2012 in-depth qualitative feedback was garnered from 40 interviews with MSW and four focus groups with 35 key informants (KIs) who had expert knowledge of the local MSW community to inform the design of an HIV-prevention intervention among MSW in Chennai, India. All MSW were recruited during outreach by employees of a Chennai-based organization for MSM (men who have sex with men). The data were analyzed using a descriptive qualitative approach. MSW and KIs discussed the need for intervention content that went beyond basic HIV psychoeducation. They emphasized the importance of addressing psychological distress, alcohol-related risk, and sexual communication skills. Concerns were raised about confidentiality, privacy, and scheduling. Participants endorsed a combination of in-person and mobile-phone-delivered sessions as well as the integration of mobile-phone messaging. These findings served as the basis for the development of a theoretically driven, manual-based intervention incorporating mobile phones. An open pilot assessed the feasibility and acceptability of the intervention with eight MSW. Assessments and HIV testing were administered at baseline, 3, and 6 months post-baseline. Exit interviews were conducted at the conclusion of the intervention. Retention for session attendance and assessment follow-up was 100 %. There was a high level of acceptability for the format, structure, and content. These data show initial promise, feasibility, and acceptability of the intervention.

  2. Prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depression: An open-label, multicenter, pilot study of efficacy, safety and effect on headache-related disability, depression, and anxiety

    Science.gov (United States)

    Boudreau, Guy P; Grosberg, Brian M; McAllister, Peter J; Lipton, Richard B; Buse, Dawn C

    2015-01-01

    Background Chronic migraine is associated with significant headache-related disability and psychiatric comorbidity. OnabotulinumtoxinA (BOTOX®) is effective and well tolerated in the prophylactic treatment of chronic migraine. This study aimed to provide preliminary data on the efficacy and safety of prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depressive symptoms. Methods This was a prospective, open-label, multicenter pilot study. Eligible patients met International Classification of Headache Disorders 2nd edition Revision criteria for chronic migraine and had associated depressive symptoms, including Patient Health Questionnaire depression module scores of 5–19. Eligible participants received 155 units of onabotulinumtoxinA, according to the PREEMPT protocol, at baseline and week 12. Assessments included headache frequency, the Headache Impact Test™, the Migraine Disability Assessment, the Beck Depression Inventory®-II, the nine-item Patient Health Questionnaire depression module, and the seven-item Generalized Anxiety Disorder questionnaire. Adverse events were also monitored. Results Overall, 32 participants received treatment. At week 24, there were statistically significant mean (standard deviation [SD]) improvements relative to baseline in the number of headache/migraine-free days (+8.2 [5.8]) (P<0.0001) and in the number of headache/migraine days (−8.2 [5.8]) (P<0.0001) per 30-day period. In addition, there were significant improvements in Headache Impact Test scores (−6.3 [6.9]) (P=0.0001) and Migraine Disability Assessment scores (−44.2 [67.5]) (P=0.0058). From baseline to week 24, statistically significant improvements were also seen in Beck Depression Inventory-II (−7.9 [6.0]) (P<0.0001), Patient Health Questionnaire depression module (−4.3 [4.7]) (P<0.0001), and Generalized Anxiety Disorder questionnaire (−3.5 [5.0]) (P=0.0002) scores. No serious adverse events were reported. Adverse events

  3. A unilateral open door laminoplasty technique: prospective analysis of the relationship between midline extensor muscle preservation and postoperative neck pain.

    Science.gov (United States)

    Park, Jin Hoon; Jeong, Eui-Kyun; Lee, Moon Kyu; Chul Rhim, Seung; Roh, Sung Woo; Kim, Jeoung Hee; Jeon, Sang Ryong

    2015-02-01

    Since laminoplasty was first introduced, several techniques have been developed to reduce postoperative neck pain and progressive kyphosis following this procedure. We describe the importance of deep muscle preservation to prevent postoperative neck pain following cervical posterior surgery, using the inter-muscular plane. We performed cervical laminoplasty on 10 patients from March to July 2012. The mean follow-up duration was 14.6 (range 12-18) months, and the mean age was 58.8 (48-68) years. There were eight men and two women in the study cohort, which consisted of eight cases of cervical spondylotic myelopathy and two cases of ossification of the posterior longitudinal ligament. The Japanese Orthopaedic Association (JOA) score and neck disability index (NDI) score were assessed before and at 6 and 12 months after surgery. The numeric rating scale (NRS) for neck pain was evaluated at 1, 3, 6, and 12 months after surgery. CT scan was performed immediately after the operation, and a radiograph was performed preoperatively and during the follow-up evaluation at 1, 3, 6, and 12 months after surgery. The preoperative JOA and NDI scores improved in all patients. Although there were two patients who complained of moderate postoperative neck pain (NRS 4 and 5), their condition gradually improved. Seven patients had mild or no neck pain (below NRS 3) at the 12 month follow-up. In addition, the cervical alignment was well maintained in all but one patient. Although larger prospective cohorts, longer follow-up periods, and comparative analyses are still needed, the clinical and radiological outcomes observed in the short 12 month period in this small cohort are promising.

  4. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial

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    Koes Bart W

    2009-05-01

    Full Text Available Abstract Background The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD. This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18–70 years visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as

  5. Characteristics of plasmids in multi-drug-resistant Enterobacteriaceae isolated during prospective surveillance of a newly opened hospital in Iraq.

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    Xiao-Zhe Huang

    Full Text Available BACKGROUND: Gram-negative multidrug-resistant (MDR bacteria are major causes of nosocomial infections, and antibiotic resistance in these organisms is often plasmid mediated. Data are scarce pertaining to molecular mechanisms of antibiotic resistance in resource constrained areas such as Iraq. METHODOLOGY/PRINCIPAL FINDINGS: In this study, all MDR Enterobacteriaceae (n = 38 and randomly selected non-MDR counterparts (n = 41 isolated from patients, healthcare workers and environmental surfaces in a newly opened hospital in Iraq were investigated to characterize plasmids found in these isolates and determine their contribution to antibiotic resistance. Our results demonstrated that MDR E. coli and K. pneumoniae isolates harbored significantly more (≥ 3 plasmids compared to their non-MDR counterparts, which carried ≤ 2 plasmids (p<0.01. Various large plasmids (~52 to 100 kb from representative isolates were confirmed to contain multiple resistance genes by DNA microarray analysis. Aminoglycoside (acc, aadA, aph, strA/B, and ksgA, β-lactam (bla(TEM1, bla(AMPC, bla(CTX-M-15, bla(OXA-1, bla(VIM-2 and bla(SHV, sulfamethoxazole/trimethoprim (sul/dfr, tetracycline (tet and chloramphenicol (cat resistance genes were detected on these plasmids. Additionally, multiple plasmids carrying multiple antibiotic resistance genes were found in the same host strain. Genetic transfer-associated genes were identified on the plasmids from both MDR and non-MDR isolates. Seven plasmid replicon types (FII, FIA, FIB, B/O, K, I1 and N were detected in the isolates, while globally disseminated IncA/C and IncHI1 plasmids were not detected in these isolates. CONCLUSIONS/SIGNIFICANCE: This is the first report of the characteristics of the plasmids found in Enterobacteriaceae isolated following the opening of a new hospital in Iraq. The information provided here furthers our understanding of the mechanisms of drug resistance in this specific region and their evolutionary

  6. Locking intramedullary nailing with and without reaming for open fractures of the tibial shaft. A prospective, randomized study.

    Science.gov (United States)

    Keating, J F; O'Brien, P J; Blachut, P A; Meek, R N; Broekhuyse, H M

    1997-03-01

    Ninety-one patients who had ninety-four open fractures of the tibial shaft were randomized into two treatment groups. Fifty fractures (nine type-I, eighteen type-II, sixteen type-IIIA, and seven type-IIIB fractures, according to the classification of Gustilo et al.) were treated with nailing after reaming, and forty-four fractures (five type-I, sixteen type-II, nineteen type-IIIA, and four type-IIIB fractures) were treated with nailing without reaming. The average diameter of the nail was 11.5 millimeters (range, nine to fourteen millimeters) in the group treated with reaming and 9.2 millimeters (range, eight to ten millimeters) in the group treated without reaming. Follow-up information was adequate for forty-five patients (forty-seven fractures) who had been managed with reaming and forty patients (forty-one fractures) who had been managed without reaming. No clinically important differences were found between the two groups with regard to the technical aspects of the procedure or the rate of early postoperative complications. The average time to union was thirty weeks (range, thirteen to seventy-two weeks) in the group treated with reaming and twenty-nine weeks (range, thirteen to fifty weeks) in the group treated without reaming. Four (9 per cent) of the fractures treated with reaming and five (12 per cent) of the fractures treated without reaming did not unite (p = 0.73). There were two infections in the group treated with reaming and one in the group treated without reaming. Significantly more screws broke in the group treated without reaming (twelve; 29 per cent) than in the group treated with reaming (four; 9 per cent) (p = 0.014). There was no difference between the two groups with regard to the frequency of broken nails (two nails that had been inserted after reaming broke, compared with one that had been inserted without reaming). The functional outcome, in terms of pain in the knee, range of motion, return to work, and recreational activity, did not

  7. Open-circuit voltage deficit, radiative sub-bandgap states, and prospects in quantum dot solar cells.

    Science.gov (United States)

    Chuang, Chia-Hao Marcus; Maurano, Andrea; Brandt, Riley E; Hwang, Gyu Weon; Jean, Joel; Buonassisi, Tonio; Bulović, Vladimir; Bawendi, Moungi G

    2015-05-13

    Quantum dot photovoltaics (QDPV) offer the potential for low-cost solar cells. To develop strategies for continued improvement in QDPVs, a better understanding of the factors that limit their performance is essential. Here, we study carrier recombination processes that limit the power conversion efficiency of PbS QDPVs. We demonstrate the presence of radiative sub-bandgap states and sub-bandgap state filling in operating devices by using photoluminescence (PL) and electroluminescence (EL) spectroscopy. These sub-bandgap states are most likely the origin of the high open-circuit-voltage (VOC) deficit and relatively limited carrier collection that have thus far been observed in QDPVs. Combining these results with our perspectives on recent progress in QDPV, we conclude that eliminating sub-bandgap states in PbS QD films has the potential to show a greater gain than may be attainable by optimization of interfaces between QDs and other materials. We suggest possible future directions that could guide the design of high-performance QDPVs.

  8. Perioperative Systemic Inflammatory Response following Robot-Assisted Laparoscopic Cystectomy vs. Open Mini-Laparotomy Cystectomy: A Prospective Study.

    Science.gov (United States)

    Skjold Kingo, Pernille; Palmfeldt, Johan; Nørregaard, Rikke; Borre, Michael; Jensen, Jørgen Bjerggaard

    2017-07-01

    Surgeries, such as radical cystectomy (RC), induce a systemic inflammatory response (SIR). SIR plays an important role in controlling the human immune system. This study aims at comparing the SIR in robot-assisted laparoscopic cystectomy (RALC) to open mini-laparotomy cystectomy (OMC) with a urinary diversion (UD). Comparison was based on immunologic markers of SIR, thus quantifying the degree of tissue trauma. Forty-two male patients underwent RC with an ileal conduit. Either OMC RC (OMC; n = 20), RALC with extracorporeal UD (RALC-EUD; n = 13), or RALC with intracorporeal UD (RALC-IUD; n = 9) was performed. Blood samples were obtained preoperatively (PREOP), immediately after surgery (POD0), 24 (POD1) and 48 h (POD2) postoperatively. Clinical parameters were collected from medical records. Estimated blood loss and blood transfusion volume was higher in OMC (p's OMC (p = 0.016). IL-10 level was higher at POD0 (p = 0.029) and POD1 (p = 0.038) in OMC vs. RALC-EUD. MCP-1 levels for RALC-IUD were significantly lower compared to RALC-EUD (p = 0.027). This study found that postoperative SIR was overall less pronounced in RALC, thus depicting reduced tissue trauma. No major clinical differences between RALC-IUD and -EUD were found. © 2017 S. Karger AG, Basel.

  9. A prospective study of comparison between Open Gastrojejunostomy and Laparoscopic Assisted Gastrojejunostomy in patients of post corrosive ingestion pyloric stenosis.

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    Samir shah

    2016-03-01

    Results: We observed that benign etiology was more common for GOO (58% compared to malignant cause (42% and post corrosive ingestion pyloric stenosis was most common benign cause(42% of GOO, Pancreatic cancer was most common malignant cause(18.5% of GOO. Corrosive ingestion was more common in younger age group (66% in 15 -30 yr age and female gender(63.34% and mostly as a suicidal attempt(86.66% and most common corrosive agent was sanitary cleansing agent(hydrochloric acid (70%.Postprandial nonbillious vomiting and weight loss were consistent symptom and appeared after 6-8 week of corrosive ingestion and 50% of patient of post corrosive ingestion pyloric stenosis had concomitant esophageal stricture. In present study those patient operated with Lap Assisted Gastrojejunostomy had smaller size of incision, reduce intra operative need of blood transfusion, less post-operative pain and less chance of wound infection, early drain and suture removal and early discharged from hospital with minimal post-operative morbidity and without significant increase in total duration and cost of operation. Conclusion : As compared to Open Gastrojejunostomy, Lap Assisted Gastrojejunostomy is better alternative operative method for pyloric stenosis. [Natl J Med Res 2016; 6(1.000: 48-50

  10. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Kim, Min Jung; Park, Sung Chan; Park, Ji Won; Chang, Hee Jin; Kim, Dae Yong; Nam, Byung-Ho; Sohn, Dae Kyung; Oh, Jae Hwan

    2017-05-25

    The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer. The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet. Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life. A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03). Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

  11. Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

    Science.gov (United States)

    Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

    2016-05-01

    Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An

  12. A prospective pilot study comparing combined intravitreal ranibizumab and half-fluence photodynamic therapy with ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration

    Directory of Open Access Journals (Sweden)

    Williams PD

    2012-09-01

    Full Text Available Patrick D Williams,1 David Callanan,1 Wayne Solley,1 Robert L Avery,2 Dante J Pieramici,2 Tom Aaberg31Texas Retina Associates, Dallas, TX, 2California Retina Consultants and Research Foundation, Santa Barbara, CA, 3Retinal Associates, Grand Rapids, MI, USAPurpose: This prospective multi-center pilot study compares the use of half-fluence photodynamic therapy combined with ranibizumab with ranibizumab monotherapy for the treatment of neovascular age-related macular degeneration.Methods: All patients presenting with untreated subfoveal neovascular age-related macular degeneration were considered for inclusion. Patients were randomized to receive either ranibizumab with half-fluence photodynamic therapy or ranibizumab alone. Patients in the ranibizumab alone group were given three consecutive monthly ranibizumab injections and were followed monthly. They were treated with ranibizumab as needed, based on clinical discretion, using vision and optical coherence tomography. Patients in the combined group were given one same-day combined ranibizumab and half-fluence (25 j/cm2 photodynamic therapy treatment and were treated monthly as needed. Outcomes included changes in standardized visual acuity, optical coherence tomography foveal thickness, and percentage of as-needed injections to maintenance examinations.Results: Fifty-six out of 60 enrolled patients completed the twelve month primary outcome visit; this consisted of 27 patients receiving ranibizumab alone and 29 receiving combined treatment. The average age was 79.1 for the ranibizumab alone group and 79.3 for the combined group. The mean visual acuity in the ranibizumab alone group improved from 52.9 Early Treatment of Diabetic Retinopathy letters initially to 62.8 letters at twelve months. The mean visual acuity in the combined group improved from 49.2 letters to 51.8 letters at twelve months. The differences in visual acuity improvements were not statistically significant based on a two

  13. Comparison of Doxycycline, Minocycline, Doxycycline plus Albendazole and Albendazole Alone in Their Efficacy against Onchocerciasis in a Randomized, Open-Label, Pilot Trial

    Science.gov (United States)

    Batsa, Linda; Ayisi-Boateng, Nana Kwame; Osei-Mensah, Jubin; Mubarik, Yusif; Konadu, Peter; Ricchiuto, Arcangelo; Fimmers, Rolf; Arriens, Sandra; Dubben, Bettina; Ford, Louise; Taylor, Mark; Hoerauf, Achim

    2017-01-01

    The search for new macrofilaricidal drugs against onchocerciasis that can be administered in shorter regimens than required for doxycycline (DOX, 200mg/d given for 4–6 weeks), identified minocycline (MIN) with superior efficacy to DOX. Further reduction in the treatment regimen may be achieved with co-administration with standard anti-filarial drugs. Therefore a randomized, open-label, pilot trial was carried out in an area in Ghana endemic for onchocerciasis, comprising 5 different regimens: the standard regimen DOX 200mg/d for 4 weeks (DOX 4w, N = 33), the experimental regimens MIN 200mg/d for 3 weeks (MIN 3w; N = 30), DOX 200mg/d for 3 weeks plus albendazole (ALB) 800mg/d for 3 days (DOX 3w + ALB 3d, N = 32), DOX 200mg/d for 3 weeks (DOX 3w, N = 31) and ALB 800mg for 3 days (ALB 3d, N = 30). Out of 158 randomized participants, 116 (74.4%) were present for the follow-up at 6 months of whom 99 participants (63.5%) followed the treatment per protocol and underwent surgery. Histological analysis of the adult worms in the extirpated nodules revealed absence of Wolbachia in 98.8% (DOX 4w), 81.4% (DOX 3w + ALB 3d), 72.7% (MIN 3w), 64.1% (DOX 3w) and 35.2% (ALB 3d) of the female worms. All 4 treatment regimens showed superiority to ALB 3d (p < 0.001, p < 0.001, p = 0.002, p = 0.008, respectively), which was confirmed by real-time PCR. Additionally, DOX 4w showed superiority to all other treatment arms. Furthermore DOX 4w and DOX 3w + ALB 3d showed a higher amount of female worms with degenerated embryogenesis compared to ALB 3d (p = 0.028, p = 0.042, respectively). These results confirm earlier studies that DOX 4w is sufficient for Wolbachia depletion and the desired parasitological effects. The data further suggest that there is an additive effect of ALB (3 days) on top of that of DOX alone, and that MIN shows a trend for stronger potency than DOX. These latter two results are preliminary and need confirmation in a fully randomized controlled phase 2 trial. Trial

  14. The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis

    Directory of Open Access Journals (Sweden)

    Lacy Antonio M

    2007-08-01

    Full Text Available Abstract Backround Diverticulosis is a common disease in the western society with an incidence of 33–66%. 10–25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger ( Method Indication for elective resection is one episode of diverticulitis in patients 50 years or in case of progressive abdominal complaints due to strictures caused by a previous episode of diverticulits. The diagnosis is confirmed by CT-scan, barium enema and/or coloscopy. It is required that the participating surgeons have performed at least 15 laparoscopic and open sigmoid resections. Open resection is performed by median laparotomy, laparoscopic resection is approached by 4 or 5 cannula. Sigmoid and colon which contain serosal changes or induration are removed and a tension free anastomosis is created. After completion of either surgical procedure an opaque dressing will be used, covering from 10 cm above the umbilicus to the pubic bone. Surgery details will be kept separate from the patient's notes. Primary endpoints are the postoperative morbidity and mortality. We divided morbidity in minor (e.g. wound infection, major (e.g. anastomotic leakage and late (e.g. incisional hernias complications, data will be collected during hospital stay and after six weeks and six months postoperative. Secondary endpoints are the operative and the postoperative recovery data. Operative data include duration of the operation, blood loss and conversion to laparotomy. Post operative recovery consists of return to normal diet, pain, analgesics, general health (SF-36 questionnaire and duration of hospital stay. Discussion The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic sigmoid resection in patients with symptomatic diverticulitis.

  15. Evaluation of augmented pulse pressure variation using the Valsalva manoeuvre as a predictor of fluid responsiveness under open-chest conditions: A prospective observational study.

    Science.gov (United States)

    Min, Jeong Jin; Kim, Tae Kyong; Lee, Jong-Hwan; Park, Jiyeon; Cho, Hyun Sung; Kim, Wook Sung; Lee, Young Tak

    2017-05-01

    Pulse pressure variation (PPV) is a well known dynamic preload indicator of fluid responsiveness. However, its usefulness in open-chest conditions remains controversial. We evaluated whether augmented PPV during a Valsalva manoeuvre can predict fluid responsiveness after sternotomy. A prospective, observational study. Single-centre trial, study period from October 2014 to June 2015. Forty-nine adult patients who underwent off-pump coronary arterial bypass grafting. After midline sternotomy, haemodynamic parameters were measured before and after volume expansion (6 ml kg of crystalloids). PPV was calculated both automatically (PPVauto) and manually (PPVmanual). For PPV augmentation, we performed Valsalva manoeuvres with manual holding of the rebreathing bag and constant airway pressure of 30 cmH2O for 10 s before fluid loading and calculated PPV during the Valsalva manoeuvre (PPVVM). The predictive ability of PPVVM for fluid responsiveness using receiver-operating characteristic curve analysis. Responders were identified when an increase in cardiac index of at least 12% occurred after fluid loading. Twenty-one patients were responders and 28 were nonresponders. PPVVM successfully predicted fluid responsiveness with an area under the curve (AUC) of 0.88 [95% confidence interval (95% CI) 0.75 to 0.95; sensitivity 91%, specificity 79%, P responsiveness [AUC 0.75 (0.62 to 0.88); sensitivity 79%, specificity 75%; and 0.76 (0.61 to 0.87]; sensitivity 71%, specificity 71%, respectively). However, only PPVVM showed a significant AUC-difference from that of central venous pressure (P = 0.008) and correlated with the change of cardiac index induced by volume expansion (r = 0.6, P responsiveness under open-chest condition. ClinicalTrials.gov identifier: NCT02457572.

  16. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study

    Science.gov (United States)

    Jendoubi, Ali; Naceur, Imed Ben; Bouzouita, Abderrazak; Trifa, Mehdi; Ghedira, Salma; Chebil, Mohamed; Houissa, Mohamed

    2017-01-01

    Background: Recently, there has been increasing interest in the use of analgesic adjuncts such as intravenous (IV) ketamine and lidocaine. Objectives: To compare the effects of perioperative IV lidocaine and ketamine on morphine requirements, pain scores, quality of recovery, and chronic pain after open nephrectomy. Study Design: A prospective, randomized, placebo-controlled, double-blind trial. Settings: The study was conducted in Charles Nicolle University Hospital of Tunis. Methods: Sixty patients were randomly allocated to receive IV lidocaine: bolus of 1.5 mg/kg at the induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively or ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively or an equal volume of saline (control group [CG]). Measurements: Morphine consumption, visual analog scale pain scores, time to the first passage of flatus and feces, postoperative nausea and vomiting (PONV), 6-min walk distance (6MWD) at discharge, and the incidence of chronic neuropathic pain using the “Neuropathic Pain Questionnaire” at 3 months. Results: Ketamine and lidocaine reduced significantly morphine consumption (by about 33% and 42%, respectively) and pain scores compared with the CG (P Lidocaine and ketamine also significantly improved bowel function in comparison to the CG (P lidocaine group (P Lidocaine, but not ketamine, reduced significantly the development of neuropathic pain at 3 months (P lidocaine are safe and effective adjuvants to decrease opioid consumption and control early pain. We also suggest that lidocaine infusion serves as an interesting alternative to improve the functional walking capacity and prevent chronic neuropathic pain at 3 months after open nephrectomy. PMID:28442956

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

    Science.gov (United States)

    Henderson, John C.; Neradilek, Moni B.; Moyer, Nicolas A.; Ashcraft, Kristine C.; Thirumaran, Ranjit K.

    2017-01-01

    Background 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. Methods and findings 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

  18. Effects of Qianlie'an(前列安) Suppository in Patients with Chronic Prostatitis Syndrome: A Randomized Open-Labelled Prospective and Controlled Trial

    Institute of Scientific and Technical Information of China (English)

    邢俊平; 陈兴发; 杨志尚; 王明珠; 贺大林

    2003-01-01

    Objective: To evaluate the clinical efficacy of Qianlie'an(前列安,QLA) suppository via anal route administration in treating chronic prostatitis syndrome. Methods: A randomized open-labelled prospective controlled trial was carried out. The total of 120 patients with chronic prostatitis syndrome were randomly divided into 2 groups: 60 patients in the treated group who were treated with QLA suppository combined with ofloxacin, and the other 60 patients in the control group who were given ofloxacin alone. The efficacy was evaluated by WBC count in the expressed prostatic secretion (EPS) and the Chronic Prostatitis Symptom Index (CPSI) made by the National Institute of Health (NIH). The clinical effects were also observed in a 4-week follow-up. Results: All but six cases completed the trial and the follow-up.It showed that in the treated group recovery rate was 17. 2%, markedly effective rate 34. 5%, effective rate 32.8%, total markedly effective rate 51.7%, and total effective rate 84. 5%, all of which were superior to those in the control group (total markedly effective rate 32.1% and total effective rate 66.1%, respectively), P<0.01. Conclusion: Administration of QLA suppository via anal route combined with oral antibiotics is an effective therapy for chronic prostatitis syndrome. It can relieve the symptoms of chronic prostatitis syndrome markedly and rapidly. It is a new choice for treatment of the disease.

  19. Postural and Balance Disorders in Patients with Parkinson’s Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment

    Directory of Open Access Journals (Sweden)

    Andrea Santamato

    2015-01-01

    Full Text Available Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson’s disease (PD to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

  20. Impact of Yoga and Meditation on Cellular Aging in Apparently Healthy Individuals: A Prospective, Open-Label Single-Arm Exploratory Study

    Science.gov (United States)

    Tolahunase, Madhuri; Sagar, Rajesh

    2017-01-01

    This study was designed to explore the impact of Yoga and Meditation based lifestyle intervention (YMLI) on cellular aging in apparently healthy individuals. During this 12-week prospective, open-label, single arm exploratory study, 96 apparently healthy individuals were enrolled to receive YMLI. The primary endpoints were assessment of the change in levels of cardinal biomarkers of cellular aging in blood from baseline to week 12, which included DNA damage marker 8-hydroxy-2′-deoxyguanosine (8-OH2dG), oxidative stress markers reactive oxygen species (ROS), and total antioxidant capacity (TAC), and telomere attrition markers telomere length and telomerase activity. The secondary endpoints were assessment of metabotrophic blood biomarkers associated with cellular aging, which included cortisol, β-endorphin, IL-6, BDNF, and sirtuin-1. After 12 weeks of YMLI, there were significant improvements in both the cardinal biomarkers of cellular aging and the metabotrophic biomarkers influencing cellular aging compared to baseline values. The mean levels of 8-OH2dG, ROS, cortisol, and IL-6 were significantly lower and mean levels of TAC, telomerase activity, β-endorphin, BDNF, and sirtuin-1 were significantly increased (all values p < 0.05) post-YMLI. The mean level of telomere length was increased but the finding was not significant (p = 0.069). YMLI significantly reduced the rate of cellular aging in apparently healthy population. PMID:28191278

  1. Impact of Yoga and Meditation on Cellular Aging in Apparently Healthy Individuals: A Prospective, Open-Label Single-Arm Exploratory Study.

    Science.gov (United States)

    Tolahunase, Madhuri; Sagar, Rajesh; Dada, Rima

    2017-01-01

    This study was designed to explore the impact of Yoga and Meditation based lifestyle intervention (YMLI) on cellular aging in apparently healthy individuals. During this 12-week prospective, open-label, single arm exploratory study, 96 apparently healthy individuals were enrolled to receive YMLI. The primary endpoints were assessment of the change in levels of cardinal biomarkers of cellular aging in blood from baseline to week 12, which included DNA damage marker 8-hydroxy-2'-deoxyguanosine (8-OH2dG), oxidative stress markers reactive oxygen species (ROS), and total antioxidant capacity (TAC), and telomere attrition markers telomere length and telomerase activity. The secondary endpoints were assessment of metabotrophic blood biomarkers associated with cellular aging, which included cortisol, β-endorphin, IL-6, BDNF, and sirtuin-1. After 12 weeks of YMLI, there were significant improvements in both the cardinal biomarkers of cellular aging and the metabotrophic biomarkers influencing cellular aging compared to baseline values. The mean levels of 8-OH2dG, ROS, cortisol, and IL-6 were significantly lower and mean levels of TAC, telomerase activity, β-endorphin, BDNF, and sirtuin-1 were significantly increased (all values p < 0.05) post-YMLI. The mean level of telomere length was increased but the finding was not significant (p = 0.069). YMLI significantly reduced the rate of cellular aging in apparently healthy population.

  2. A Prospective, Open Label, Observational Study to Assess the Safety and Efficacy of Herbal Cough Syrup Mykoff® in Patients Suffering from Cough of Varied Aetiologies

    Directory of Open Access Journals (Sweden)

    Mangesh Bhalerao

    2013-06-01

    Full Text Available A prospective, open label, observational study was conducted at general outpatient clinic to assess the safety and efficacy of herbal cough syrup Mykoff® in patients suffering from cough of varied aetiologies. The patients of either sex, age > 3yrs, suffering from cough due to common cold, mild to moderate upper respiratory tract infections, allergic cough and smoker’s cough were enrolled. The safety was evaluated by means of an analysis of adverse events. In addition, efficacy and tolerability were analysed from the following grades by patients and confirmed by doctor. Of 50 patients, 63% were diagnosed with cough due to upper respiratory tract infections, 17% common cold, 12% allergic cough and 8% smoker’s cough. Substantial improvement, i.e., excellent to good response, in relief of cough was noted in 42 (84% out of 50 patients and fair response in another 4 (8%. Only 4 out of 50 patients showed no relief in symptoms. Most of the patients (98% accepted the remedy well. Only one adverse event was reported. However, a relation to the medication was classified to be unlikely. The test drug Mykoff® is an effective and safe cough syrup that is highly acceptable for patients with cough of short duration.

  3. Postural and Balance Disorders in Patients with Parkinson's Disease: A Prospective Open-Label Feasibility Study with Two Months of Action Observation Treatment.

    Science.gov (United States)

    Santamato, Andrea; Ranieri, Maurizio; Cinone, Nicoletta; Stuppiello, Lucia Anna; Valeno, Giovanni; De Sanctis, Jula Laura; Fortunato, Francesca; Solfrizzi, Vincenzo; Greco, Antonio; Seripa, Davide; Panza, Francesco

    2015-01-01

    Action observation treatment has been proposed as therapeutic option in rehabilitation of patients affected by Parkinson's disease (PD) to improve freezing of gait episodes. The purpose of this prospective open-label feasibility study was to evaluate the impact of 8-week action observation training (video-therapy) for the treatment of postural instability and balance impairment in PD patients. Fifteen PD patients aged under 80 years with scores of 1 to 3 on the Hoehn and Yahr staging and without evidence of freezing of gait were recruited. They underwent 24 sessions of video-therapy training based on carefully watching video clips on motor tasks linked to balance, subsequently performing the same observed movements. No statistically significant differences were observed in the identified outcome measures with the Berg Balance Scale and the Activities-Specific Balance Confidence Scale after two months of follow-up. In the present study, a short course of action observation treatment seems to be not effective in reducing balance impairments and postural instability in patients affected by mild to moderate PD. Further studies with larger samples, longer follow-up period, and standardized protocols of action observation treatment are needed to investigate the effects of this rehabilitation technique in the management of postural and balance disorders of PD patients.

  4. Comparing blastocyst quality and live birth rates of intravaginal culture using INVOcell™ to traditional in vitro incubation in a randomized open-label prospective controlled trial.

    Science.gov (United States)

    Doody, Kevin J; Broome, E Jason; Doody, Kathleen M

    2016-04-01

    The purpose of this study is to to compare the efficacy of intravaginal culture (IVC) of embryos in INVOcell™ (INVO Bioscience, MA, USA) to traditional in vitro fertilization (IVF) incubators in a laboratory setting using a mild pre-determined stimulation regimen based solely on anti-mullerian hormone (AMH) and body weight with minimal ultrasound monitoring. The primary endpoint examined was total quality blastocysts expressed as a percentage of total oocytes placed in incubation. Secondary endpoints included percentage of quality blastocysts transferred, pregnancy, and live birth rates. In this prospective randomized open-label controlled single-center study, 40 women aged culture. IVF produced a greater percentage of total quality embryos as compared to IVC (50.6 vs. 30.7 %, p = 0.0007, respectively). There was no significant difference between in IVF and IVC in the percentage of quality blastocysts transferred (97.5 vs. 84.9 %, p = 0.09) or live birth rate (60 % IVF, 55 % IVC). IVF was shown to be superior to IVC in creating quality blastocysts. However, both IVF and IVC produced identical blastocysts for transfer resulting in similar live birth rates. IVC using INVOcell™ is effective and may broaden access to fertility care in selected patient populations by ameliorating the need for a traditional IVF laboratory setting. Further studies will help elucidate the potential physiological, psychological, geographic, and financial impact of IVC on the delivery of fertility care.

  5. Effectiveness of telemedicine and distance learning applications for patients with chronic heart failure. A protocol for prospective parallel group non-randomised open label study.

    Science.gov (United States)

    Vanagas, Giedrius; Umbrasiene, Jelena; Slapikas, Rimvydas

    2012-01-01

    Chronic heart failure in Baltic Sea Region is responsible for more hospitalisations than all forms of cancer combined and is one of the leading causes of hospitalisations in elderly patients. Frequent hospitalisations, along with other direct and indirect costs, place financial burden on healthcare systems. We aim to test the hypothesis that telemedicine and distance learning applications is superior to the current standard of home care. Prospective parallel group non-randomised open label study in patients with New York Heart Association (NYHA) II-III chronic heart failure will be carried out in six Baltic Sea Region countries. The study is organised into two 6-month follow-up periods. The first 6-month period is based on active implementation of tele-education and/or telemedicine for patients in two groups (active run period) and one standard care group (passive run period). The second 6-month period of observation will be based on standard care model (passive run period) to all three groups. Our proposed practice change is based on translational research with empirically supported interventions brought to practice and aims to find the home care model that is most effective to patient needs. This study has been approved by National Bioethics Committee (2011-03-07; Registration No: BE-2-11). This study has been registered in Australian New Zealand Clinical Trials Registry (ANZCTR) with registration number ACTRN12611000834954.

  6. Prospective, non-interventional, uncontrolled, open-chart, pharmacoepidemiologic study of prescribing patterns for anti-diabetic drugs at tertiary care hospital in Erode

    Directory of Open Access Journals (Sweden)

    Radhika P

    2009-01-01

    Full Text Available The aim of this study is to determine current prescribing patterns for anti-diabetic drugs adopted by physicians in Erode. The prospective, non interventional, uncontrolled, open-chart, pharmacoepidemiological study was conducted from January -2007 to April -2007 at a diabetic care centre having 350 diabetic patients. The pattern of prescribing anti-diabetic drugs was recorded along with glycosylated haemoglobin levels, total cholesterol, high-density lipoprotein, low-density lipoprotein, very low-density lipoprotein and triglycerides in insulin-dependent diabetes mellitus and non-insulin-dependent diabetes mellitus patients and the values were observed. The prescribing pattern of the oral anti-diabetic drugs shows that out of the various oral anti-diabetic drugs′ available, drugs from only two groups were prescribed. Sulphonylureas, biguanides and combination therapy accounts for 31.43%, 20.28% and 33.71% of prescriptions, respectively, while insulin alone and with OAD′s accounts for 6.28% and 8.29% prescriptions, respectively. Overall, prescribing trend is away from monotherapy with insulin and sulphonylureas and towards combination therapies.

  7. Low-dose total skin electron beam therapy as a debulking agent for cutaneous T-cell lymphoma: an open-label prospective phase II study

    DEFF Research Database (Denmark)

    Kamstrup, Maria Rørbæk; Lindahl, L M; Gniadecki, Robert

    2011-01-01

    Background: Total skin electron beam therapy (TSEBT) is a powerful treatment for cutaneous T-cell lymphomas (CTCL). Based on the occurrence of relapses with low radiation doses, doses of 30-36 Gy are commonly used but most patients still eventually relapse and repeat treatment courses are limited...... due to the cumulative toxicity. Complete response rates are about 60-90% for T2-4 stages with a 5-year relapse-free survival of 10-25% for stages IB-III. Objectives: To evaluate prospectively the efficacy of low-dose TSEBT (10 Gy) in terms of complete cutaneous response rate, overall response rate...... and response duration in CTCL. Methods: Ten patients with stage IB-IV mycosis fungoides (MF) were treated in an open-label manner with 4 fractions of 1 Gy/week TSEB to a total skin dose of 10 Gy. Treatment responses were assessed at 1 and 3 months after treatment and subsequently at least every 6 months...

  8. Toepasbaarheid en effectiviteit van mindfulnesstraining bij volwassenen met AD(H)D; een open pilotonderzoek [Feasibility and effectiveness of mindfulness training in adults with ADHD: A pilot study

    NARCIS (Netherlands)

    Hepark, S.; Kan, C.C.; Speckens, A.E.M.

    2014-01-01

    BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a developmental disorder that often continues into adulthood. Stimulant medication is the common treatment for ADHD. However, there is a need for psychosocial interventions in addition to medication. AIM: To conduct a pilot study which e

  9. A phase 4, single-arm, open-label, pilot study of maraviroc, raltegravir and darunavir/r in HIV-1 adults with triple class failure: TERCETO study

    Directory of Open Access Journals (Sweden)

    P Patterson

    2012-11-01

    Full Text Available The purpose of this phase 4, single-arm, open-label study was to evaluate the safety, tolerability, efficacy, antiviral and immunological activity of maraviroc (MVC in combination with raltegravir (RGV and darunavir/r (DRV/r in adult HIV-1 infected patients (pts with limited treatment options. HIV-1 pts with documented virologic triple class failure or multi-drug class resistance defined as the presence of Q151 complex, 69 insertion complex and/or≥3 TAMs for NRTIs and K103N, G190S+Y181C or Y188L mutants for NNRTIs and≥3 RAMs (L10F/I/R/V; M46I/L; I54V/M/L; V82A/F/T/S; I84V; L90M for protease inhibitors (PIs were offered a triple drug regimen consisting of MVC 150 mg BID, RGV 400 mg BID and DRV/r 600/100 mg BID. Safety, lipid profile and virologic efficacy were evaluated at week 4, 12, 24, 36 and 48. Between January 2010 and March 2012, 27 pts were enrolled. Screening failure rate was 52% due to undetectable viral load (pVL or non R5 tropism type (Trofile™. Despite being heavily pre-treated pts, only 26% had negative tropism test at SCR. Baseline characteristics of 13 included pts were: 77% male, median age 43 years (IQR: 40.1–48.6, 38% had a prior AIDS-defining condition. Median BSL pVL was 23,350 cps/mL (4.4 log10 (IQR: 11,236–55,785 and median CD4 was 222 cells/mm3 (IQR: 179–318. Median time on NRTIs, NNRTIs and PIs were 10.7 (8.6–13.7, 1.7 (1.3–7.6 and 5.4 (4.7–10 years respectively. Pts had received a median of 2 PIs (IQR: 2–3. 8/13 pts showed thymidine analogue-associated mutations (TAMs, and≥2 were present in 5/13. Detectable NNRTI resistance-associated mutations (RAMs were present in 10/13 patients. 9/13 had≥4 primary PI RAMs. At 48 weeks, 2 pts had discontinued therapy (OIs related death (cryptococcal meningitis=1, withdrawn from the study on W36 due to blips despite not achieving criteria for virologic failure=1 and the remaining pts (11/13 achieved undetectable pVL and increased CD4 in 133 cell/mm3 from BSL (IQR

  10. Prospective, naturalistic study of open-label OROS methylphenidate treatment in Chinese school-aged children with attention-deficit/hyperactivity disorder

    Institute of Scientific and Technical Information of China (English)

    ZHENG Yi; GONG Mei-en; YIN Qing-yun; MAI Jian-ning; JING Jin; LUO Xiang-yang; MA Hong-wei; LI Hai-bo; XIE Ling; LI Yan; Kuang Gui-fang; WANG Yu-feng; YI Ming-ji; WANG Feng; ZHU Xiao-hua; YAO Yah-bin; QIN Jiong; WANG Li-wen; ZOU Li-ping; JIN Xing-ming; XU Tong; WANG Yi; QI Yuan-li

    2011-01-01

    Background Attention deficit hyperactivity disorder (ADHD) is one of the most common mental disorders during childhood,characterized by the core symptoms of hyperactivity,impulsivity and inattention and puts great burden on children themselves,their families and the society.Osmotic release oral system methylphenidate (OROS-MPH) is a once-daily controlled-release formulation developed to overcome some of the limitations associated with immediate-release methylphenidate (IR-MPH).It has been marketed in China since 2005 but still lacks data from large-sample clinical trials on efficacy and safety profiles.The aim of this study was to evaluate the effectiveness and safety of OROS-MPH in children aged 6 to 16 years with ADHD under naturalistic clinical setting.Methods This 6-week,multi-center,prospective,open-label study enrolled 1447 ADHD children to once-daily OROS-MPH (18 mg,36 mg or 54 mg) treatment.The effectiveness measures were parent-rated Inattention and Overactivity With Aggression (IOWA) Conners I/O and O/D subscales,physician-rated CGI-I and parent-rated global efficacy assessment scale.Blood pressure,pulse rate measurement,adverse events (AEs) and concomitant medications and treatment review were conducted by the investigator and were served as safety measures.Results A total of 1447 children with ADHD (mean age (9.52±2.36) years) were enrolled in this trial.Totally 96.8%children received an OROS-MPH modal dose of 18 mg,3.1% with 36 mg and 0.1% with 54 mg at the endpoint of study.The parent IOWA Conners I/O score at the end of week 2 showed statistically significant (P <0.001) improvement with OROS-MPH (mean:6.95±2.71) versus the score at baseline (10.45±2.72).The change in the parent IOWA Conners O/D subscale,CGI-I and parent-rated global efficacy assessment scale also supported the superior efficacy for OROS-MPH treatment.Fewer than half of 1447 patients (511 (35.3%)) reported AEs,and the majority of the events reported were mild (68.2

  11. Pilot prospective evaluation of {sup 18}F-FPPRGD{sub 2} PET/CT in patients with cervical and ovarian cancer

    Energy Technology Data Exchange (ETDEWEB)

    Minamimoto, Ryogo; Jamali, Mehran; Gambhir, Sanjiv Sam [Stanford University, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford, CA (United States); Stanford University, Molecular Imaging Program at Stanford (MIPS), Department of Radiology, Stanford, CA (United States); Karam, Amer; Dorigo, Oliver [Stanford University, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Stanford, CA (United States); Barkhodari, Amir; Iagaru, Andrei [Stanford University, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology, Stanford, CA (United States)

    2016-06-15

    We report the effect of antiangiogenic therapy on the biodistribution of {sup 18}F-FPPRGD{sub 2} (a surrogate biomarker of integrin α{sub v}β{sub 3} expression), and the potential of {sup 18}F-FPPRGD{sub 2} to predict the prognosis in patients with cervical cancer and ovarian cancer in this clinical scenario. Data from six women, age range 30 - 59 years (mean ± SD 44.0 ± 12.5 years), who had undergone a {sup 18}F-FPPRGD{sub 2} PET/CT scan and bevacizumab-containing therapy were prospectively collected and analyzed. We compared baseline {sup 18}F-FPPRGD{sub 2} and {sup 18}F-FDG uptake in the lesions and tumor-to-background (T/B) ratios. The maximum and mean {sup 18}F-FPPRGD{sub 2} standardized uptake values (SUV{sub max} and SUV{sub mean}) were recorded for 13 normal organs, as well as in all the identified malignant lesions on the pretreatment scan and the 1-week post-treatment scan. We also measured changes in {sup 18}F-FPPRGD{sub 2} uptake from before to 1 week after treatment{sub ,} and compared them to the changes in {sup 18}F-FDG uptake from before to 6 weeks after treatment. Treatment outcomes were correlated with these changes. The uptake in lesions and T/B ratio of {sup 18}F-FPPRGD{sub 2} were lower than those of {sup 18}F-FDG (SUV{sub max} 3.7 ± 1.3 vs. 6.0 ± 1.8, P < 0.001; SUV{sub mean} 2.6 ± 0.7 vs. 4.2 ± 1.3, P < 0.001; T/B ratio based on SUV{sub max} 2.4 ± 1.0 vs. 2.6 ± 1.0, P < 0.04; T/B ratio based on SUV{sub mean} 1.9 ± 0.6 vs. 2.4 ± 1.0, P < 0.003). One patient did not return for the follow-up scan and in another patient no lesions were identified on the pretreatment scan. {sup 18}F-FPPRGD{sub 2} uptake in lesions in the remaining four patients had significantly changed 1 week after treatment (SUV{sub mean} 3.3 ± 1.0 vs. 2.7 ± 1.0, P < 0.001), while uptake in all normal tissues analyzed was not affected by treatment. One patient with clinical disease progression had a decrease in lesional {sup 18}F-FPPRGD{sub 2} SUV{sub mean} of 1

  12. Lamivudine switch therapy in chronic hepatitis B patients achieving undetectable hepatitis B virus DNA after 3 years of entecavir therapy: A prospective, open-label, multicenter study.

    Science.gov (United States)

    Yeh, Ming-Lun; Huang, Ching-I; Hsieh, Ming-Yen; Huang, Chung-Feng; Hsieh, Meng-Hsuan; Huang, Jee-Fu; Dai, Chia-Yen; Lin, Zu-Yau; Chen, Shinn-Chern; Yu, Ming-Lung; Chuang, Wan-Long

    2016-11-01

    The subsequent maintenance therapy in chronic hepatitis B (CHB) patients after long-term viral replication suppression is still uncertain. We aim to evaluate the efficacy of lamivudine (LAM) maintenance therapy in CHB patients achieving undetectable hepatitis B virus (HBV) DNA after 3 years of entecavir (ETV) therapy. Consecutive CHB patients who received at least 3 years of ETV and achieved HBV DNA negativity were allocated either LAM switch therapy or stopped ETV therapy in a prospective, open-label study. Another group of sex- and age-matched patients with continuous ETV therapy for at least 4 years served as historical control group. The primary outcome measurement of the study was relapse of HBV DNA (defined as serum HBV DNA level ≥ 2000 IU/mL). A total of 74 patients, including 42 of LAM switch and 32 of the nonswitch group, were enrolled. There were no significant differences in demographics, except a higher proportion of patients with positive hepatitis B envelope antigen in the nonswitch group at the initiation of ETV therapy. The LAM switch group had significantly lower 1-year relapse rate of HBV within 1 year compared to the nonswitch group (14.3% vs. 75%, p<0.001). However, none of the 48 historical control patients developed relapse of HBV, which was significantly lower than the rate in LAM switch group (p < 0.001). LAM switch was the only factor associated with HBV DNA relapse. In conclusion, continuous long-term potent nucleot(s)ide analogue therapy is mandatory for prevention of viral relapse in CHB patients. Copyright © 2016 Kaohsiung Medical University. Published by Elsevier Taiwan.. All rights reserved.

  13. Lamivudine switch therapy in chronic hepatitis B patients achieving undetectable hepatitis B virus DNA after 3 years of entecavir therapy: A prospective, open-label, multicenter study

    Directory of Open Access Journals (Sweden)

    Ming-Lun Yeh

    2016-11-01

    Full Text Available The subsequent maintenance therapy in chronic hepatitis B (CHB patients after long-term viral replication suppression is still uncertain. We aim to evaluate the efficacy of lamivudine (LAM maintenance therapy in CHB patients achieving undetectable hepatitis B virus (HBV DNA after 3 years of entecavir (ETV therapy. Consecutive CHB patients who received at least 3 years of ETV and achieved HBV DNA negativity were allocated either LAM switch therapy or stopped ETV therapy in a prospective, open-label study. Another group of sex- and age-matched patients with continuous ETV therapy for at least 4 years served as historical control group. The primary outcome measurement of the study was relapse of HBV DNA (defined as serum HBV DNA level ≥ 2000 IU/mL. A total of 74 patients, including 42 of LAM switch and 32 of the nonswitch group, were enrolled. There were no significant differences in demographics, except a higher proportion of patients with positive hepatitis B envelope antigen in the nonswitch group at the initiation of ETV therapy. The LAM switch group had significantly lower 1-year relapse rate of HBV within 1 year compared to the nonswitch group (14.3% vs. 75%, p < 0.001. However, none of the 48 historical control patients developed relapse of HBV, which was significantly lower than the rate in LAM switch group (p < 0.001. LAM switch was the only factor associated with HBV DNA relapse. In conclusion, continuous long-term potent nucleot(side analogue therapy is mandatory for prevention of viral relapse in CHB patients.

  14. The effects of household wealth on HIV prevalence in Manicaland, Zimbabwe – a prospective household census and population-based open cohort study

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    Nadine Schur

    2015-11-01

    Full Text Available Introduction: Intensified poverty arising from economic decline and crisis may have contributed to reductions in HIV prevalence in Zimbabwe. Objectives: To assess the impact of the economic decline on household wealth and prevalent HIV infection using data from a population-based open cohort. Methods: Household wealth was estimated using data from a prospective household census in Manicaland Province (1998 to 2011. Temporal trends in summed asset ownership indices for sellable, non-sellable and all assets combined were compared for households in four socio-economic strata (small towns, agricultural estates, roadside settlements and subsistence farming areas. Multivariate logistic random-effects models were used to measure differences in individual-level associations between prevalent HIV infection and place of residence, absolute wealth group and occupation. Results: Household mean asset scores remained similar at around 0.37 (on a scale of 0 to 1 up to 2007 but decreased to below 0.35 thereafter. Sellable assets fell substantially from 2004 while non-sellable assets continued increasing until 2008. Small-town households had the highest wealth scores but the gap to other locations decreased over time, especially for sellable assets. Concurrently, adult HIV prevalence fell from 22.3 to 14.3%. HIV prevalence was highest in better-off locations (small towns but differed little by household wealth or occupation. Initially, HIV prevalence was elevated in women from poorer households and lower in men in professional occupations. However, most recently (2009 to 2011, men and women in the poorest households had lower HIV prevalence and men in professional occupations had similar prevalence to unemployed men. Conclusions: The economic crisis drove more households into extreme poverty. However, HIV prevalence fell in all socio-economic locations and sub-groups, and there was limited evidence that increased poverty contributed to HIV prevalence decline.

  15. Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): A prospective, assessor-blind, randomised controlled pilot trial

    OpenAIRE

    Freeman, D; Waite, F.; Startup, H; Myers, E; Lister, R.; McInerney, J; Harvey, AG; Geddes, J.; Zaiwalla, Z; Luengo-Fernandez, R.; Foster, R.; Clifton, L; Yu, LM

    2015-01-01

    Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods ...

  16. Prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depression: An open-label, multicenter, pilot study of efficacy, safety and effect on headache-related disability, depression, and anxiety

    Directory of Open Access Journals (Sweden)

    Boudreau GP

    2015-02-01

    Full Text Available Guy P Boudreau,1 Brian M Grosberg,2 Peter J McAllister,3 Richard B Lipton,2 Dawn C Buse2 1Clinique de la Migraine et Céphalées, Département de Neurologie, Centre Hospitalier de L’Université de Montréal, Hôpital Notre-Dame, Montreal, QC, Canada; 2Montefiore Headache Center and the Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA; 3New England Institute for Neurology and Headache, Stamford, and The Frank H Netter School of Medicine at Quinnipiac University, Hamden, CT, USA Background: Chronic migraine is associated with significant headache-related disability and psychiatric comorbidity. OnabotulinumtoxinA (BOTOX® is effective and well tolerated in the prophylactic treatment of chronic migraine. This study aimed to provide preliminary data on the efficacy and safety of prophylactic onabotulinumtoxinA in patients with chronic migraine and comorbid depressive symptoms. Methods: This was a prospective, open-label, multicenter pilot study. Eligible patients met International Classification of Headache Disorders 2nd edition Revision criteria for chronic migraine and had associated depressive symptoms, including Patient Health Questionnaire depression module scores of 5–19. Eligible participants received 155 units of onabotulinumtoxinA, according to the PREEMPT protocol, at baseline and week 12. Assessments included headache frequency, the Headache Impact Test™, the Migraine Disability Assessment, the Beck Depression Inventory®-II, the nine-item Patient Health Questionnaire depression module, and the seven-item Generalized Anxiety Disorder questionnaire. Adverse events were also monitored. Results: Overall, 32 participants received treatment. At week 24, there were statistically significant mean (standard deviation [SD] improvements relative to baseline in the number of headache/migraine-free days (+8.2 [5.8] (P<0.0001 and in the number of headache/migraine days (–8.2 [5.8] (P<0.0001 per 30-day period. In

  17. Effectiveness of Digital Medicines to Improve Clinical Outcomes in Patients with Uncontrolled Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-Randomized Pilot Clinical Trial

    Science.gov (United States)

    Frias, Juan; Raja, Praveen; Kim, Yoona; Savage, George; Osterberg, Lars

    2017-01-01

    Background Hypertension and type 2 diabetes mellitus are major modifiable risk factors for cardiac, cerebrovascular, and kidney diseases. Reasons for poor disease control include nonadherence, lack of patient engagement, and therapeutic inertia. Objective The aim of this study was to assess the impact on clinic-measured blood pressure (BP) and glycated hemoglobin (HbA1c) using a digital medicine offering (DMO) that measures medication ingestion adherence, physical activity, and rest using digital medicines (medication taken with ingestible sensor), wearable sensor patches, and a mobile device app. Methods Participants with elevated systolic BP (SBP ≥140 mm Hg) and HbA1c (≥7%) failing antihypertensive (≥2 medications) and oral diabetes therapy were enrolled in this three-arm, 12-week, cluster-randomized study. Participants used DMO (includes digital medicines, the wearable sensor patch, and the mobile device app) for 4 or 12 weeks or received usual care based on site randomization. Providers in the DMO arms could review the DMO data via a Web portal. In all three arms, providers were instructed to make medical decisions (medication titration, adherence counseling, education, and lifestyle coaching) on all available clinical information at each visit. Primary outcome was change in SBP at week 4. Other outcomes included change in SBP and HbA1c at week 12, and low-density lipoprotein cholesterol (LDL-C) and diastolic blood pressure (DBP) at weeks 4 and 12, as well as proportion of patients at BP goal (<140/90 mm Hg) at weeks 4 and 12, medical decisions, and medication adherence patterns. Results Final analysis included 109 participants (12 sites; age: mean 58.7, SD years; female: 49.5%, 54/109; Hispanic: 45.9%, 50/109; income ≤ US $20,000: 56.9%, 62/109; and ≤ high school education: 52.3%, 57/109). The DMO groups had 80 participants (7 sites) and usual care had 29 participants (5 sites). At week 4, DMO resulted in a statistically greater SBP reduction than usual care (mean –21.8, SE 1.5 mm Hg vs mean –12.7, SE 2.8 mmHg; mean difference –9.1, 95% CI –14.0 to –3.3 mm Hg) and maintained a greater reduction at week 12. The DMO groups had greater reductions in HbA1c, DBP, and LDL-C, and a greater proportion of participants at BP goal at weeks 4 and 12 compared with usual care. The DMO groups also received more therapeutic interventions than usual care. Medication adherence was ≥80% while using the DMO. The most common adverse event was a self-limited rash at the wearable sensor site (12%, 10/82). Conclusions For patients failing hypertension and diabetes oral therapy, this DMO, which provides dose-by-dose feedback on medication ingestion adherence, can help lower BP, HbA1c, and LDL-C, and promote patient engagement and provider decision making. Trial Registration Clinicaltrials.gov NCT02827630; https://clinicaltrials.gov/show/NCT02827630 (Archived by WebCite at http://www.webcitation.org/6rL8dW2VF) PMID:28698169

  18. Efficacy and safety of Everolimus in children with TSC - associated epilepsy – Pilot data from an open single-center prospective study

    OpenAIRE

    Samueli, Sharon; Abraham, Klaus; Dressler, Anastasia; Gröppel, Gudrun; Mühlebner-Fahrngruber, Angelika; Scholl, Theresa; Kasprian, Gregor; Laccone, Franco; Feucht, Martha

    2016-01-01

    Background Epilepsy occurs in up to 90 % of all individuals with tuberous sclerosis complex (TSC). In 67 % disease onset is during childhood. In ≥ 50 % seizures are refractory to currently available treatment options. The mTOR-Inhibitor Everolimus (Votubia®) was approved for the treatment of subependymal giant cell astrocytoma (SEGA) and renal angiomyolipoma (AML) in Europe in 2011. It’s anticonvulsive/antiepileptic properties are promising, but evidence is still limited. Study aim was to eva...

  19. Benefits of use, and tolerance of, medium-chain triglyceride medical food in the management of Japanese patients with Alzheimer's disease: a prospective, open-label pilot study.

    Science.gov (United States)

    Ohnuma, Tohru; Toda, Aiko; Kimoto, Ayako; Takebayashi, Yuto; Higashiyama, Ryoko; Tagata, Yuko; Ito, Masanobu; Ota, Tsuneyoshi; Shibata, Nobuto; Arai, Heii

    2016-01-01

    This is the first clinical trial of this type in Japan, designed to analyze two important aspects of Alzheimer's disease (AD) management using medium-chain triglycerides. Axona was administered for 3 months (40 g of powder containing 20 g of caprylic triglycerides). We used an indurating, four-step dose-titration method (from 10 to 40 g per day) for 7 days before the trial, and examined the tolerance and adverse effects of this intervention. We also investigated its effect on cognitive function in mild-to-moderate AD patients. This was a clinical intervention in 22 Japanese patients with sporadic AD at a mild-to-moderate stage (ten females, 12 males), mean age (± standard deviation) 63.9 (±8.5) years, Mini-Mental State Examination (MMSE) score, 10-25, seven patients were ApoE4-positive. During Axona administration, we examined changes in cognitive function by obtaining MMSE and AD assessment-scale scores. Intolerance and serum ketone concentrations were also examined. The tolerance of Axona was good, without severe gastrointestinal adverse effects. Axona did not improve cognitive function in our sample of AD patients, even in those patients without the ApoE4 allele. However, some ApoE4-negative patients with baseline MMSE score ≥14 showed improvement in their cognitive functions. The modified dose-titration method, starting with a low dose of Axona, decreased gastrointestinal adverse effects in Japanese patients. Axona might be effective for some relatively mildly affected patients with AD (with cognitive function MMSE score of ≥14 and lacking the ApoE4 allele).

  20. Toepasbaarheid en effectiviteit van mindfulnesstraining bij volwassenen met AD(H)D; een open pilotonderzoek [Feasibility and effectiveness of mindfulness training in adults with ADHD: A pilot study

    OpenAIRE

    Hepark, S.; Kan, C C; Speckens, A.E.M.

    2014-01-01

    BACKGROUND: Attention deficit hyperactivity disorder (ADHD) is a developmental disorder that often continues into adulthood. Stimulant medication is the common treatment for ADHD. However, there is a need for psychosocial interventions in addition to medication. AIM: To conduct a pilot study which examines the feasibility and effectiveness of mindfulness training for adults with ADHD. METHOD: Eleven adults with ADHD participated in a mindfulness training scheme lasting 10 weeks. ADHD symptoms...

  1. High beverage sugar as well as high animal protein intake at infancy may increase overweight risk at 8 years: a prospective longitudinal pilot study.

    NARCIS (Netherlands)

    Weijs, J.M. Peter; Kool, M. Laura; Baar, M. van Nicolien; Zee, C. van der Saskia

    2011-01-01

    Background: Combined effects of early exposure to beverage sugar and animal protein and later life overweight risk have not been studied. Methods: A prospective longitudinal study was initiated in 2001 with 226 infants between 4 and 13 months of age. Dietary intake was assessed with a 2 day food rec

  2. Effectiveness of artemether-lumefantrine provided by community health workers in under-five children with uncomplicated malaria in rural Tanzania: an open label prospective study

    Directory of Open Access Journals (Sweden)

    Blessborn Daniel

    2011-03-01

    Full Text Available Abstract Background Home-management of malaria (HMM strategy improves early access of anti-malarial medicines to high-risk groups in remote areas of sub-Saharan Africa. However, limited data are available on the effectiveness of using artemisinin-based combination therapy (ACT within the HMM strategy. The aim of this study was to assess the effectiveness of artemether-lumefantrine (AL, presently the most favoured ACT in Africa, in under-five children with uncomplicated Plasmodium falciparum malaria in Tanzania, when provided by community health workers (CHWs and administered unsupervised by parents or guardians at home. Methods An open label, single arm prospective study was conducted in two rural villages with high malaria transmission in Kibaha District, Tanzania. Children presenting to CHWs with uncomplicated fever and a positive rapid malaria diagnostic test (RDT were provisionally enrolled and provided AL for unsupervised treatment at home. Patients with microscopy confirmed P. falciparum parasitaemia were definitely enrolled and reviewed weekly by the CHWs during 42 days. Primary outcome measure was PCR corrected parasitological cure rate by day 42, as estimated by Kaplan-Meier survival analysis. This trial is registered with ClinicalTrials.gov, number NCT00454961. Results A total of 244 febrile children were enrolled between March-August 2007. Two patients were lost to follow up on day 14, and one patient withdrew consent on day 21. Some 141/241 (58.5% patients had recurrent infection during follow-up, of whom 14 had recrudescence. The PCR corrected cure rate by day 42 was 93.0% (95% CI 88.3%-95.9%. The median lumefantrine concentration was statistically significantly lower in patients with recrudescence (97 ng/mL [IQR 0-234]; n = 10 compared with reinfections (205 ng/mL [114-390]; n = 92, or no parasite reappearance (217 [121-374] ng/mL; n = 70; p ≤ 0.046. Conclusions Provision of AL by CHWs for unsupervised malaria treatment at home

  3. Yokukansan (TJ-54 for treatment of pervasive developmental disorder not otherwise specified and Asperger’s disorder: a 12-week prospective, open-label study

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    Miyaoka Tsuyoshi

    2012-11-01

    Full Text Available Abstract Background Numerous medications have been tested on patients with pervasive developmental disorder not otherwise specified (PDD-NOS and Asperger’s disorder. Although many of these medications have been demonstrated to be useful, no clear primary treatment for PDD-NOS and Asperger’s disorder has emerged. Despite the efficacy of some of the medicines, the acceptability and side effects have proven to be barriers to their use. Recent studies indicate that the traditional Japanese herbal medicine yokukansan (TJ-54 may be safe and useful in treating behavioral and psychological symptoms in dementia and some neuropsychiatric disorders. We aimed at evaluating both the efficacy and safety of TJ-54 in patients with well-defined PDD-NOS and Asperger’s disorder. Methods This was a 12-week prospective, open-label investigation of TJ-54 in 40 children, adolescents, and adults diagnosed with PDD-NOS or Asperger’s disorder. Primary outcome measures included the Clinical Global Impressions-Severity of Illness Scale (CGI-S and the Aberrant Behavior Checklist-Iritability subscale score (ABC-I. Results Forty subjects, ages 8–40 years (mean 22.7 ± 7.3 years received a mean final TJ-54 dosage of 6.4 ± 1.3 g/day (range 2.5-7.5 g/day. Full-scale intelligence quotient (IQ scores ranged from 70 to 110 (mean 88.9 ± 13.2. Thirty-six (90% of 40 subjects showed fewer interfering symptoms of irritability, including aggression, self-injury, and tantrums, with a final CGI-S of 1 or 2 (normal, not at all ill or borderline mentally ill and a 80% or greater improvement on the ABC-I. The mean CGI-S score at baseline was 6.8 ± 0.8 whereas scores at end point was 1.9 ± 0.1 ( Conclusions These preliminary data suggest that TJ-54 may be effective and well tolerated for treatment of severe irritability, lethargy/withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech in patients with PDD-NOS or Asperger’s disorder. However

  4. Efficacy and safety of flexibly dosed paliperidone palmitate in Chinese patients with acute schizophrenia: an open-label, single-arm, prospective, interventional study

    Directory of Open Access Journals (Sweden)

    Si TM

    2015-06-01

    Full Text Available Tianmei Si,1 Kerang Zhang,2 Jisheng Tang,3 Maosheng Fang,4 Keqing Li,5 Jianmin Zhuo,6 Yu Feng6 1Peking University Institute of Mental Health, Key Laboratory of Mental Health, Ministry of Health, Beijing, People’s Republic of China; 2Shanxi Medical University First Hospital, Shanxi, People’s Republic of China; 3Mental Health Center of Shandong Province, Shandong, People’s Republic of China; 4Mental Health Center, Tongji Medical College, Huazhong University of Science and Technology, Hubei, People’s Republic of China; 5Mental Health Center of Hebei Province, Hebei, People’s Republic of China; 6Janssen Research and Development, Beijing, People’s Republic of China Abstract: This open-label, single-arm, multicenter, 13-week, prospective study explored the efficacy, safety, and tolerability of paliperidone palmitate (150 milligram equivalents [mg eq] [day 1], 100 mg eq [day 8], both deltoid injections; 75–150 mg eq, deltoid/gluteal injection in Chinese patients with acute schizophrenia (Positive and Negative Syndrome Scale [PANSS] total score ≥70, who previously had unsatisfactory therapeutic effect following oral antipsychotic treatment (without washout period. Primary efficacy endpoint was percentage of patients with ≥30% improvement in the PANSS total score at the end of 13 weeks. Secondary efficacy endpoints included change from baseline to end of week 13 in PANSS total score, PANSS subscale scores, Marder factor scores, Clinical Global Impressions–Severity score, and Personal and Social Performance Scale scores. Overall, 477/610 enrolled patients (full analysis set, 78.2% completed the study (men: 55.1%; women: 44.9%; mean age: 31.5 years. Total, 443/610 (72.6%, full analysis set patients achieved primary endpoint (mean [standard deviation] change from baseline: –30.9 [19.51]. All secondary endpoints demonstrated significant improvement at the end of 13 weeks. One death occurred during this acute phase. The most common (>5

  5. Milnacipran treatment and potential biomarkers in depressed patients following an initial SSRI treatment failure: a prospective, open-label, 24-week study

    Directory of Open Access Journals (Sweden)

    Hashimoto T

    2015-12-01

    Full Text Available Tasuku Hashimoto,1,2 Daiji Sakurai,1 Yasunori Oda,1 Tadashi Hasegawa,3 Nobuhisa Kanahara,4 Tsuyoshi Sasaki,3 Hideki Komatsu,3,5 Junpei Takahashi,1,5 Takahiro Oiwa,6 Yoshimoto Sekine,4,5 Hiroyuki Watanabe,1 Masaomi Iyo1,3 1Department of Psychiatry, Chiba University Graduate School of Medicine, 2Sodegaura Satsukidai Hospital, 3Department of Psychiatry, Chiba University Hospital, 4Division of Medical Treatment and Rehabilitation, Centre for Forensic Mental Health, Chiba University, 5Choshi Kokoro Clinic, 6Mobara Shinkeika Hospital, Chiba, Japan Background: We assessed the effect of switching patients with major depressive disorder to milnacipran following an initial selective serotonin reuptake inhibitor treatment failure, and explored potential biomarkers in their blood.Methods: We conducted a prospective, open-label, 24-week trial. Depression was assessed with the 17-item Hamilton Depression Rating Scale. Patients showing a ≥50% reduction in Hamilton Depression Rating Scale scores from baseline to final visit were considered responders. Regarding adverse effects (AEs, moderate-to-severe AEs were specifically identified as effects that required any medical treatment or that induced treatment withdrawals. We also measured blood levels of various molecules including inflammatory cytokines.Results: Of the 30 participants who enrolled, 17 completed this study. The responder rate was 30% (n=10. Baseline serum levels of interleukin-6 (Z=-2.155; P=0.031 and interleukin-8 (Z=-2.616; P=0.009 were significantly higher when moderate-to-severe AEs were present (n=13 patients with moderate-to-severe AEs. Serum levels of macrophage inflammatory protein-1β showed a significant continuous decrease from the baseline level (Friedman’s test: χ2=23.9, df=4, P<0.001 only in non-responders.Conclusion: These results demonstrate that serum levels of interleukin-6, interleukin-8, and macrophage inflammatory protein-1β as potential blood biomarkers could be utilized

  6. A Prospective, Multicentre, Open-Label Single-Arm Exploratory Study to Evaluate Efficacy and Safety of Saroglitazar on Hypertriglyceridemia in HIV Associated Lipodystrophy.

    Directory of Open Access Journals (Sweden)

    Alka Deshpande

    Full Text Available This study was designed to explore the efficacy and safety of saroglitazar 4 mg on hypertriglyceridemia in patients with HIV associated lipodystrophy.During this 12-week prospective, multi-centric, open-label, single arm exploratory study, 50 patients were enrolled to receive saroglitazar 4 mg orally once daily in the morning before breakfast. The primary efficacy endpoint was the percent change in triglyceride (TG levels from baseline to Week 6 and Week 12. The secondary efficacy endpoints were assessment of low-density-lipoprotein (LDL, very-low-density-lipoprotein (VLDL, high-density-lipoprotein (HDL, non-HDL cholesterol, total cholesterol, apo-lipoprotein (Apo A1, Apo B, and C-peptide and fasting insulin for HOMA beta and HOMA IR. Safety assessment was performed during the study.Saroglitazar 4 mg significantly decreased the serum TG levels from baseline at Week 6 (percent change: -40.98; 95% CI: -50.82, -31.15 and Week 12 (percent change -45.11; 95% CI: -52.37, -37.86. Reduction in VLDL cholesterol (percent change: -46.33; 95% CI: -52.89, -39.76 and total cholesterol (percent change: 7.37; 95% CI: 1.96, 12.78 was observed at week 12 from baseline. Saroglitazar increased HDL cholesterol (percent change: 34.56, 95% CI: 22.22, 46.90, Apo A1 (percent change: 33.16; 95% CI: 18.69, 47.63 and Apo B (percent change: 10.55, 95% CI: 2.86, 18.25 levels at week 12 from baseline. Saroglitazar treatment led to increase in the C-peptide (percent change: 59.42, 95% CI: 48.78, 70.06, fasting insulin levels (percent change: 47.10; 95% CI: 38.63, 55.57, HOMA of beta cell function for C-peptide (percent change: 71.67; 95% CI: 39.09, 104.26 and HOMA of insulin resistance for C-peptide (percent change: 58.29, 95% CI: 46.74, 69.83 at week 12 from baseline. Saroglitazar treatment was safe and well tolerated in this study.Overall, the observed changes in lipid profile after 12 weeks of saroglitazar treatment were in the direction of improvement in patients with HIV

  7. Efficacy and safety of once-monthly injection of paliperidone palmitate in hospitalized Asian patients with acute exacerbated schizophrenia: an open-label, prospective, noncomparative study

    Directory of Open Access Journals (Sweden)

    Li HF

    2015-12-01

    Full Text Available HuaFang Li,1 Ibrahim Turkoz,2 Fan Zhang3 1Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 2Janssen Research & Development, LLC, Titusville, NJ, USA; 3Xi’an Janssen Pharmaceutical Ltd., Beijing, People’s Republic of China Introduction: This single-group, open-label, prospective, noncomparative, multicenter, Phase IV study explored the efficacy and tolerability of paliperidone palmitate (PP in hospitalized patients with acute exacerbation of schizophrenia.Methods: Asian patients of either sex, between 18 and 65 years of age, diagnosed with schizophrenia (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition with acute exacerbations within the previous 4 weeks, were enrolled. Intramuscular PP was initiated at doses of 150 milligram equivalent (mg eq (day 1 and 100 mg eq (day 8, followed by a monthly maintenance dose between 75 mg eq and 150 mg eq (days 36 and 64. Primary efficacy endpoint was the change from baseline in the Positive and Negative Syndrome Scale (PANSS total score (last-observation-carried-forward at week 13.Results: Of the 212 enrolled patients, 152 (71.7% completed the 13-week treatment; withdrawal of consent (24 [11.3%] patients was the most common reason for study discontinuation. Mean (standard deviation PANSS total score from baseline (90.0 [17.41] improved significantly at day 4 (-6.1 [9.27]; 95% confidence interval: -7.38, -4.85; P<0.001 and week 13 endpoint (-23.9 [23.24]; 95% confidence interval: -27.10, -20.78; P<0.001. Similarly, the secondary endpoints (Clinical Global Impression-Severity, Physical and Social Performance, each PANSS subscale, and Marder factor scores improved significantly from baseline to week 13 endpoint (P<0.001 for all. At week 13, 112/210 (53.3% patients had a 40% improvement in the PANSS total score (responder rate, and 133/212 (62.7% patients were ready for hospital discharge. Overall, 139 (65

  8. The effect of a monocular helmet-mounted display on aircrew health: a 10-year prospective cohort study of Apache AH MK 1 pilots: study midpoint update

    Science.gov (United States)

    Hiatt, Keith L.; Rash, Clarence E.; Watters, Raymond W.; Adams, Mark S.

    2009-05-01

    A collaborative occupational health study has been undertaken by Headquarters Army Aviation, Middle Wallop, UK, and the U.S. Army Aeromedical Research Laboratory, Fort Rucker, Alabama, to determine if the use of the Integrated Helmet and Display Sighting System (IHADSS) monocular helmet-mounted display (HMD) in the Apache AH Mk 1 attack helicopter has any long-term (10-year) effect on visual performance. The test methodology consists primarily of a detailed questionnaire and an annual battery of vision tests selected to capture changes in visual performance of Apache aviators over their flight career (with an emphasis on binocular visual function). Pilots using binocular night vision goggles serve as controls and undergo the same methodology. Currently, at the midpoint of the study, with the exception of a possible colour discrimination effect, there are no data indicating that the long-term use of the IHADSS monocular HMD results in negative effects on vision.

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

    Directory of Open Access Journals (Sweden)

    Adit Srivastava

    2015-01-01

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

  10. Feasibility and safety of augmented-reality glass for computed tomography-assisted percutaneous revascularization of coronary chronic total occlusion: A single center prospective pilot study.

    Science.gov (United States)

    Opolski, Maksymilian P; Debski, Artur; Borucki, Bartosz A; Staruch, Adam D; Kepka, Cezary; Rokicki, Jakub K; Sieradzki, Bartosz; Witkowski, Adam

    2017-09-21

    Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) may be facilitated by projection of coronary computed tomography angiography (CTA) datasets in the catheterization laboratory. There is no data on the feasibility and safety outcomes of CTA-assisted CTO PCI using a wearable augmented-reality glass. A total of 15 patients scheduled for elective antegrade CTO intervention were prospectively enrolled and underwent preprocedural coronary CTA. Three-dimensional and curved multiplanar CT reconstructions were transmitted to a head-mounted hands-free computer worn by interventional cardiologists during CTO PCI to provide additional information on CTO tortuosity and calcification. The results of CTO PCI using a wearable computer were compared with a time-matched prospective angiographic registry of 59 patients undergoing antegrade CTO PCI without a wearable computer. Operators' satisfaction was assessed by a 5-point Likert scale. Mean age was 64 ± 8 years and the mean J-CTO score was 2.1 ± 0.9 in the CTA-assisted group. The voice-activated co-registration and review of CTA images in a wearable computer during CTO PCI were feasible and highly rated by PCI operators (4.7/5 points). There were no major adverse cardiovascular events. Compared with standard CTO PCI, CTA-assisted recanalization of CTO using a wearable computer showed more frequent selection of the first-choice stiff wire (0% vs 40%, p augmented-reality glass is feasible and safe, and might reduce the resources required for the interventional treatment of CTO. Copyright © 2017 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.

  11. How Extraverted, Open, Agreeable, Conscientious, and Neurotic Are Prospective Early Childhood Pedagogues? A Comparison with the German Socio-Economic Panel

    Science.gov (United States)

    Smidt, Wilfried; Roux, Susanna

    2015-01-01

    Against the background of theories and research, it is crucial to gather in-depth information about the Big Five personality traits of pedagogues as well as prospective pedagogues. Such information can be attained by comparing them with a cross section of the population. However, there is a research gap concerning the Big Five of early childhood…

  12. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial

    Directory of Open Access Journals (Sweden)

    Kim Kun

    2011-06-01

    Full Text Available Abstract Background Persistent non-specific low back pain (PNSLBP is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP. Methods We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to100 numerical rating scale (NRS for pain, the McGill Pain Questionnaire for pain intensity (PPI and the Oswestry Disability Questionnaire (ODQ, and we assessed acetaminophen use and safety issues. Results The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group, but there was no statistical difference between the groups (p = 0.52. However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p Conclusion This pilot study may provide preliminary data on the effectiveness and safety of wet-cupping treatments for PNSLBP. Future full-scale randomised controlled trials will be needed to provide firm evidence of the effectiveness of this intervention

  13. A prospective survey in European Society of Cardiology member countries of atrial fibrillation management: baseline results of EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry.

    Science.gov (United States)

    Lip, Gregory Y H; Laroche, Cécile; Dan, Gheorghe-Andrei; Santini, Massimo; Kalarus, Zbigniew; Rasmussen, Lars Hvilsted; Oliveira, Mário Martins; Mairesse, Georges; Crijns, Harry J G M; Simantirakis, Emmanouil; Atar, Dan; Kirchhof, Paulus; Vardas, Panos; Tavazzi, Luigi; Maggioni, Aldo P

    2014-03-01

    Given the advances in atrial fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in ESC member countries. We conducted a registry of consecutive in- and outpatients with AF presenting to cardiologists in nine participating ESC countries. All patients with an ECG-documented diagnosis of AF confirmed in the year prior to enrolment were eligible. We enroled a total of 3119 patients from February 2012 to March 2013, with full data on clinical subtype available for 3049 patients (40.4% female; mean age 68.8 years). Common comorbidities were hypertension, coronary disease, and heart failure. Lone AF was present in only 3.9% (122 patients). Asymptomatic AF was common, particularly among those with permanent AF. Amiodarone was the most common antiarrhythmic agent used (∼20%), while beta-blockers and digoxin were the most used rate control drugs. Oral anticoagulants (OACs) were used in 80% overall, most often vitamin K antagonists (71.6%), with novel OACs being used in 8.4%. Other antithrombotics (mostly antiplatelet therapy, especially aspirin) were still used in one-third of the patients, and no antithrombotic treatment in only 4.8%. Oral anticoagulants were used in 56.4% of CHA2DS2-VASc = 0, with 26.3% having no antithrombotic therapy. A high HAS-BLED score was not used to exclude OAC use, but there was a trend towards more aspirin use in the presence of a high HAS-BLED score. The EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot Registry has provided systematic collection of contemporary data regarding the management and treatment of AF by cardiologists in ESC member countries. Oral anticoagulant use has increased, but novel OAC use was still low. Compliance with the treatment guidelines for patients with the lowest and higher stroke risk scores remains suboptimal.

  14. 'Out of hours' adult CT head interpretation by senior emergency department staff following an intensive teaching session: a prospective blinded pilot study of 405 patients.

    Science.gov (United States)

    Jamal, Karim; Mandel, Laura; Jamal, Leila; Gilani, Shamim

    2014-06-01

    Cranial CT is the gold standard for the investigation of intracranial emergencies. The aim of this pilot study was to audit whether senior emergency physicians were able to report CT head scans accurately and reliably having attended structured teaching. Senior emergency physicians attended a 3 h teaching session. Following this, they independently reported adult CT head scans between 22:00 and 08:00 using a pro forma. CT head examinations performed in this 'out of hours' period were formally reported by a consultant radiologist on the following morning. Data were collected in a blinded fashion over an 8-month period. 405 adult CT head examinations were performed. 360 pro formas were available for analysis, and the rest were excluded either because a consultant radiologist had been rung to discuss the results (five patients) or because the pro forma was not completed (40 patients). Concordance between consultant radiologists and emergency physicians was found in 339 (94%) of the cases (κ coefficient 0.78). None of the discordant cases was managed inappropriately or had an adverse clinical outcome. All cases of extradural, subdural and subarachnoid haemorrhage were detected by emergency physicians. In conclusion, we feel that this model can be employed as a safe and long-term alternative provided that the radiology department are committed to providing ongoing teaching and that a database is maintained to highlight problem areas. Emergency physicians need to remember that the clinical status of the patient must never be ignored, irrespective of their CT head findings. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  15. The hepatoprotective and hypolipidemic effects of Spirulina (Arthrospira platensis) supplementation in a Cretan population with non-alcoholic fatty liver disease: a prospective pilot study

    Science.gov (United States)

    Mazokopakis, Elias E.; Papadomanolaki, Maria G.; Fousteris, Andreas A.; Kotsiris, Dimitrios A.; Lampadakis, Ioannis M.; Ganotakis, Emmanuel S.

    2014-01-01

    Background A pilot study was conducted to determine the effects of Spirulina (Arthrospira platensis) on Cretan patients with non-alcoholic fatty liver disease (NAFLD). Spirulina is a filamentous cyanobacterium taken as a dietary supplement. Methods Fifteen adult Cretan outpatients (13 men), median age 48 (range: 29-62) years, with NAFLD were orally supplemented with 6 g of Spirulina (Greek production) per day for six months. Anthropometric characteristics (height, weight, waist circumference), systolic and diastolic blood pressure, complete blood count, biochemical assessments, homeostasis model assessment of insulin resistance (HOMA-IR) index, health-related quality of life and abdominal sonographic findings were recorded and measured, before and after Spirulina supplementation. Results At the end of the 6-month intervention period, the mean levels of aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase, triglycerides, low-density lipoprotein-cholesterol, total cholesterol, and the ratio of total cholesterol to high-density lipoprotein cholesterol were significantly decreased: 38.5%, 37.5%, 26.7%, 24.8%, 9.6%, 9.1%, and 13.5% respectively, whereas the mean levels of high-density lipoprotein-cholesterol and hemoglobin were significantly increased: 4.2% and 4.1% respectively. Spirulina supplementation resulted also in a significant reduction in weight and HOMA-IR index (8.1% and 19.6% respectively) and a significant improvement in health-related quality of life scale. No changes in sonographic findings were observed. Conclusion Spirulina supplementation at a high dosage of 6 g daily in NAFLD patients has strong and multiple beneficial metabolic effects and improves their health-related quality of life. PMID:25331487

  16. Fit for Birth - the effect of weight changes in obese pregnant women on maternal and neonatal outcomes: a pilot prospective cohort study.

    Science.gov (United States)

    Narayanan, R P; Weeks, A D; Quenby, S; Rycroft, D; Hart, A; Longworth, H; Charnley, M; Abayomi, J; Topping, J; Turner, M A; Wilding, J P H

    2016-02-01

    The 'Fit for Birth' study aimed to explore patterns of gestational weight gain and their relationship with pregnancy outcomes. The study had three aims: 1. To explore the feasibility of conducting a large cohort study in this setting. 2. To describe patterns of weight gain through pregnancy in obese women. 3. To explore associations of weight change during pregnancy with outcomes. Pregnant women with a BMI ≥ 30 kg m(-2) at first antenatal clinic visit. This was a single centre pilot observational study based at the Liverpool Women's Hospital, a large UK maternity hospital.Women were recruited into the study at their antenatal booking visit and had weights measured throughout pregnancy. Patterns of weight gain were described and related to maternal and neonatal outcomes. The primary outcome was a composite measure consisting of any of 12 adverse maternal and foetal outcomes. This was compared by categorized pregnancy weight gain (9 kg). Eight hundred and twenty four women consented to participation between June 2009 and June 2010. Weight data were collected on 756 women. Only 385 women had weights measured in all three study assessment periods (6-20 weeks, 20 + 1 to 32 weeks and >32 weeks gestation) while 427 women had weights measured in period 3. Individual patterns of weight gain varied widely and missing data were common and non-random. There was a significant association between increased weight gain during pregnancy and poor maternal and foetal outcome. Weight gain in obese women during pregnancy can be highly variable. Our study supports an association between increased weight gain in pregnancy and adverse perinatal outcomes. © 2015 World Obesity.

  17. Modified CBT using visualization for Autism Spectrum Disorder (ASD), anxiety and avoidance behavior – a quasi-experimental open pilot study

    Science.gov (United States)

    Ekman, Elizabeth; Hiltunen, Arto J

    2015-01-01

    In recent studies it has been suggested that Cognitive Behavior Therapy (CBT) is beneficial to people with Autism Spectrum Disorder (ASD) but that the method needs to be modified in relation to their cognitive profile. The aim of this study is to measure the effect of modified CBT, that is, using visualized language throughout the entire session for clients with ASD and anxiety and avoidance behavior. The modification of CBT in this study consists of focusing on CBT protocols for anxiety disorders and depression, while visualizing and systematizing “the invisible” in the conversation, in order for the clients to understand the social, cognitive and emotional context of self and others and how they should interact to avoid misunderstandings. ASD clients may need help to detect the invisible code of social interaction and communication. The level of anxiety and the frequency of target behavior were measured. Four assessments were made, two at the pre-assessment, and one in mid-therapy and end of therapy respectively. Generally, results suggest no improvement during pre-treatment period but a significant improvement during treatment. The values of the clients’ psychological, social and occupational ability to function improved on the Global Function Rating scale. The preliminary conclusion of this pilot study indicates that the use of visualized language throughout the CBT therapy sessions is a promising modification of current CBT protocols for individuals with ASD. After manualization, larger studies with randomized controlled study designs can replicate or challenge these results. PMID:26565732

  18. Modified CBT using visualization for Autism Spectrum Disorder (ASD), anxiety and avoidance behavior--a quasi-experimental open pilot study.

    Science.gov (United States)

    Ekman, Elizabeth; Hiltunen, Arto J

    2015-12-01

    In recent studies it has been suggested that Cognitive Behavior Therapy (CBT) is beneficial to people with Autism Spectrum Disorder (ASD) but that the method needs to be modified in relation to their cognitive profile. The aim of this study is to measure the effect of modified CBT, that is, using visualized language throughout the entire session for clients with ASD and anxiety and avoidance behavior. The modification of CBT in this study consists of focusing on CBT protocols for anxiety disorders and depression, while visualizing and systematizing "the invisible" in the conversation, in order for the clients to understand the social, cognitive and emotional context of self and others and how they should interact to avoid misunderstandings. ASD clients may need help to detect the invisible code of social interaction and communication. The level of anxiety and the frequency of target behavior were measured. Four assessments were made, two at the pre-assessment, and one in mid-therapy and end of therapy respectively. Generally, results suggest no improvement during pre-treatment period but a significant improvement during treatment. The values of the clients' psychological, social and occupational ability to function improved on the Global Function Rating scale. The preliminary conclusion of this pilot study indicates that the use of visualized language throughout the CBT therapy sessions is a promising modification of current CBT protocols for individuals with ASD. After manualization, larger studies with randomized controlled study designs can replicate or challenge these results.

  19. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; Design of a prospective randomized controlled trial

    NARCIS (Netherlands)

    P.A. Brouwer (Patrick); W.C. Peul (Wilco); R. Brand (René); M.P. Arts (Mark); B.W. Koes (Bart); A.A. van den Berg (Annette); M.A. van Buchem (Mark)

    2009-01-01

    textabstractBackground. The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser

  20. The effect of intact fibula on functional outcome of reamed intramedullary interlocking nail in open and closed isolated tibial shaft fractures: A prospective study

    Directory of Open Access Journals (Sweden)

    S Muthukumar Balaji

    2016-01-01

    Conclusion: ITS fracture with intact fibula is a common occurrence, and they can be treated safely with reamed IM nailing that provides good union rates and the excellent functional result even in open fractures.

  1. Case study: Gold road to Open Access in research publishing domain - experience of Institute of Chemical Technology Prague from the pilot project

    Directory of Open Access Journals (Sweden)

    Jirát Jiří

    2014-07-01

    Full Text Available Elektronické informační zdroje (e-časopisy, e-knihy, databáze patří mezi základní nepostradatelné pilíře výzkumu a vývoje, ČR za nř plánuje vy-dat v letech 2013-2017/8 přes 3 mld. Kč. Současně však celosvětově do-chází k velké diskusi a posunům v oblasti odborného publikování směrem k tzv. otevřenému přístupu (Open Access. Zejména Evropská unie v následujících letech silně podpoří Open Access v oblasti odborného publikování (finanční podporou i donucením v rámci pravidel nových programů. Jaké praktické důsledky to bude mít pro výzkumné institu-ce v oblasti chemie, je ukázáno na příkladu pilotního projektu VŠCHT Praha. Analýza vyhodnocuje, jak jsou jednotlivé možnosti Open Access blízké zvyklostem autorů v oblasti chemie. Vyplývá z ní, že autoři zatím jednoznačně preferují tzv. zlatou cestu (gold Open Access. Výsledky pilotního projektu naznačují vhodnost centralizace podpory zlaté cesty Open Access na národní úrovni.

  2. Prospective 1-year follow-up pilot study of CT-guided microwave ablation in the treatment of bone and soft-tissue malignant tumours

    Energy Technology Data Exchange (ETDEWEB)

    Aubry, Sebastien; Kastler, Bruno [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); University of Franche-Comte, I4S laboratory, INSERM EA4268, Besancon (France); Dubut, Jonathan; Nueffer, Jean-Philippe [University Hospital of Besancon, Department of Musculoskeletal Imaging, Besancon (France); Chaigneau, Loic [University Hospital of Besancon, Department of Oncology, Besancon (France); Vidal, Chrystelle [University Hospital of Besancon, Clinical Investigation Center, INSERM CIT808, Besancon (France)

    2017-04-15

    The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation (MWA) in the treatment of malignant musculoskeletal tumours. Sixteen bone and soft-tissue malignant tumours were prospectively included and were treated by CT-guided MWA. The percentage and size of necrosis of the lesions were measured by contrast-enhanced MRI before the procedure and after 1, 3, 6 and 12 months. mRECIST criteria were used to assess tumour response. Procedural success was defined as ≥80 % necrosis. Patient pain (as assessed using a numeric visual scale (NVS)) and side effects were noted. Six osteolytic metastases, five osteoblastic metastases and five soft tissue sarcomas were treated. At 1 month, 40 % were treated completely, the percentage of necrosis was 85 ± 30.4 %, and the success rate was 80 %. At 3, 6 and 12 months the success rate was 80 %, 76.9 % and 63.6 %, respectively. At 12 months, four lesions (36.3 %) still had no recurrence. Mean NVS during the procedure was 3.5 ± 2.8. One patient had transitory sciatica without neurological deficit that was treated medically. CT-guided MWA of bone and soft-tissue malignant tumours is efficient, well tolerated and has good short-term anti-cancer effects. (orig.)

  3. Efficacy of Traditional Chinese Medicine in Xerostomia and Quality of Life during Radiotherapy for Head and Neck Cancer: A Prospective Pilot Study

    Directory of Open Access Journals (Sweden)

    Pei-Yu Hsu

    2016-01-01

    Full Text Available Xerostomia is one of the most common acute and late complications of radiotherapy for head and neck cancer, and it affects quality of life. We conducted a prospective study to evaluate the efficacy of traditional Chinese medicine (TCM in toxicities and quality of life during radiotherapy. Head and neck cancer patients who were scheduled for radiotherapy were checked for inclusion/exclusion criteria before enrollment. Patients in the study group (inpatients were hospitalized in a Chinese medicine ward and received concomitant TCM intervention during radiotherapy, while those in the control group (outpatients received only conventional cancer treatments at the Western outpatient department. The primary end point was amelioration of postradiotherapy side effects. The secondary end points were quality of life during the cancer therapy and occurrence of adverse events following the TCM treatments. Thirty inpatients and 50 outpatients completed the study. Compared to the control group, those in the TCM group had decreased severity of xerostomia. There was no treatment-related impairment of renal or hepatic function among TCM group. Although better outcomes of social contact, dyspnea, physical and emotional function, and financial problems were found in the TCM group, we need further confirmation about the impact of hospitalization itself on these results.

  4. Effect of an electronic nicotine delivery device (e-Cigarette on smoking reduction and cessation: a prospective 6-month pilot study

    Directory of Open Access Journals (Sweden)

    Papale Gabriella

    2011-10-01

    Full Text Available Abstract Background Cigarette smoking is a tough addiction to break. Therefore, improved approaches to smoking cessation are necessary. The electronic-cigarette (e-Cigarette, a battery-powered electronic nicotine delivery device (ENDD resembling a cigarette, may help smokers to remain abstinent during their quit attempt or to reduce cigarette consumption. Efficacy and safety of these devices in long-term smoking cessation and/or smoking reduction studies have never been investigated. Methods In this prospective proof-of-concept study we monitored possible modifications in smoking habits of 40 regular smokers (unwilling to quit experimenting the 'Categoria' e-Cigarette with a focus on smoking reduction and smoking abstinence. Study participants were invited to attend a total of five study visits: at baseline, week-4, week-8, week-12 and week-24. Product use, number of cigarettes smoked, and exhaled carbon monoxide (eCO levels were measured at each visit. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Results Sustained 50% reduction in the number of cig/day at week-24 was shown in 13/40(32.5% participants; their median of 25 cigs/day decreasing to 6 cigs/day (p Conclusion The use of e-Cigarette substantially decreased cigarette consumption without causing significant side effects in smokers not intending to quit (http://ClinicalTrials.gov number NCT01195597.

  5. Implementation of a safe-by-design approach in the development of new open pilot lines for the manufacture of carbon nanotube-based nano-enabled products

    Science.gov (United States)

    López de Ipiña, Jesús M.; Hernan, Angel; Cenigaonaindia, Xabier; Insunza, Mario; Florez, Sonia; Seddon, Richard; Vavouliotis, Antonios; Kostopoulos, Vasilios; Latko, Paulina; Durałek, Paweł; Kchit, Nadir

    2017-06-01

    The project PLATFORM (H2020, GA 646307) aims to develop three new pilot lines (PPLs) for the manufacture of carbon nanotube-based nano-enabled products (buckypapers, treated prepregs, doped veils), for the European aeronautics and automotive industries (a Technology Readiness Level 6 - TRL6 - is expected at the end of the project). The Machinery Directive 2006/42/EC (MD) - transposed into the respective national legislations - is the European regulatory framework for the design and construction of new machinery, as the future PPLs. PPLs are not required to comply with the provisions of the MD until they are put into service - expected in 2020, after project completion - but then, the MD will be fully applicable. In this regulatory context, the project PLATFORM is aligning the design of the PPLs according to the MD requirements, in order to facilitate the CE marking in 2020 (TRL9) and avoid potential economic costs associated with future re-adaptations or modifications needed to ensure compliance with the MD. This paper discusses the methodological approach followed by the project PLATFORM to integrate all the nanosafety aspects in the design of the PPLs, in order to achieve safe designs in conformity with the relevant Essential Health and Safety Requirements (EHSRs) of the MD. Since machinery must be designed and constructed taking into account the results of the risk assessment (RA), this paper describes the systematic and iterative approach for RA and risk reduction followed to eliminate hazards as far practicable and to adequately reduce risks by the implementation of protective measures. This process has been guided by the harmonized standards EN ISO 12100 and EN ISO 14123, taking the relevant phases of life cycle, expected uses and operation modes of the PPLs into account. A specific tool to guide the safe design of the PPLs and facilitate the RA process has also been produced by the project (PLATFORM - SbD toolkit).

  6. Clinical, Laboratorial, and Urodynamic Findings of Prostatic Artery Embolization for the Treatment of Urinary Retention Related to Benign Prostatic Hyperplasia. A Prospective Single-Center Pilot Study

    Energy Technology Data Exchange (ETDEWEB)

    Antunes, Alberto A. [University of Sao Paulo Medical School, Division of Urology (Brazil); Carnevale, Francisco C., E-mail: fcarnevale@uol.com.br; Motta Leal Filho, Joaquim M. da [University of Sao Paulo Medical School, Interventional Radiology Unit (Brazil); Yoshinaga, Eduardo M. [University of Sao Paulo Medical School, Division of Urology (Brazil); Cerri, Luciana M. O. [University of Sao Paulo Medical School, Ultrasound Unit (Brazil); Baroni, Ronaldo H. [University of Sao Paulo Medical School, Magnetic Resonance Unit (Brazil); Marcelino, Antonio S. Z. [University of Sao Paulo Medical School, Ultrasound Unit (Brazil); Cerri, Giovanni G. [University of Sao Paulo Medical School, Radiology Department (Brazil); Srougi, Miguel [University of Sao Paulo Medical School, Division of Urology (Brazil)

    2013-08-01

    PurposeThis study was designed to describe the clinical, laboratorial, and urodynamic findings of prostatic artery embolization (PAE) in patients with urinary retention due to benign prostatic hyperplasia (BPH).MethodsA prospective study of 11 patients with urinary retention due to BPH was conducted. Patients underwent physical examination, prostate specific antigen (PSA) measurement, transrectal ultrasound, and magnetic resonance imaging. International prostate symptom score (IPSS), quality of life (QoL), and urodynamic testing were used to assess the outcome before and after 1 year.ResultsClinical success was 91 % (10/11 patients) with a mean follow-up of 22.3 months (range, 12-41 months). At the first year follow-up, the mean IPSS score was 2.8 points (p = 0.04), mean QoL was 0.4 points (p = 0.001), mean PSA decreased from 10.1 to 4.3 ng/mL (p = 0.003), maximum urinary flow (Qmax) improved from 4.2 to 10.8 mL/sec (p = 0.009), and detrusor pressure (Pdet) decreased from 85.7 to 51.5 cm H{sub 2}O (p = 0.007). Before PAE, Bladder Outlet Obstruction Index (BOOI) showed values >40 in 100 % of patients. After PAE, 30 % of patients were >40 (obstructed), 40 % were between 20 and 40 (undetermined), and 30 % were <20 (unobstructed). Patients with a BOOI <20 had higher PSA values at 1-day after PAE.ConclusionsClinical and urodynamic parameters improved significantly after PAE in patients with acute urinary retention due to BPH. Total PSA at day 1 after PAE was higher in patients with unobstructed values in pressure flow studies.

  7. Is there a role for hyperbaric oxygen as primary treatment for grade IV radiation-induced haemorrhagic cystitis? a prospective pilot-feasibility study and review of literature

    Energy Technology Data Exchange (ETDEWEB)

    Dellis, Athanasios [Surgical Department, University of Athens, Aretaieion Hospital (Greece); Deliveliotis, Charalambos [Urologic Department, University of Athens, Sismanoglio General Hospital (Greece); Kalentzos, Vasileios; Vavasis, Pavlos; Skolarikos, Andreas [Diving and Hyperbaric Oxygen Department, Naval and Veterans Hospital, Athens (Greece)

    2014-05-15

    Purpose: To examine the safety and efficacy of hyperbaric oxygen as the primary treatment for Grade IV radiation-induced haemorrhagic cystitis. Materials and Methods: Hyperbaric oxygen was prospectively applied as a primary treatment option in 11 patients with Grade IV radiation cystitis. Primary endpoint was the incidence of complete and partial response to treatment. Secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival. Results: All patients completed therapy without complications for a mean follow-up of 17.82 months (range 3 to 34). Mean number of sessions needed was 32.8 (range 27 to 44). Complete and partial response rate was 81.8% and 18.2%, respectively. However, in three patients the first treatment session was not either sufficient or durable giving a 72.7% rate of durable effect. Interestingly, all 9 patients with complete response received therapy within 6 months of the haematuria onset compared to the two patients with partial response who received therapy at 8 and 10 months from the haematuria onset, respectively (p = 0.018). The need for blood transfusion (p = 0.491) and the total radiation dose (p = 0.259) were not correlated to success-rate. One patient needed cystectomy, while all patients were alive at the end of follow-up. Conclusions: Early primary use of hyperbaric oxygen to treat radiation-induced grade IV cystitis is an effective and safe treatment option. (author)

  8. Comparative alveolar ridge preservation using allogenous tooth graft versus free-dried bone allograft: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2017-01-01

    Full Text Available Background: For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA in alveolar ridge preservation. Materials and Methods: Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases. Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL, mineralized whole tooth allograft (WTA and dentin allograft (DA were prepared using the standard protocol of Tissue Bank at Tata Memorial Hospital, Mumbai, India. Study Design: In this randomized controlled trial, 15 patients undergoing extraction of at least four teeth were selected. In each patient after atraumatic extractions, one socket was grafted with WTA, second with DA, third with FDBA, and fourth was left ungrafted (control site. All the sites were covered with chorion membrane. To estimate three-dimensional alveolar crest changes, cone beam computed tomography scans were taken immediately after grafting and 4 months postoperatively. Bone biopsies using 3 mm trephine bur were obtained from four patients at the time of implant placement and evaluated histologically. Results: Clinically uneventful healing was observed at all sites. Compared to other sites, WTA and DA consistently showed superior results demonstrating least reduction in alveolar crest height and width which was statistically significant (P < 0.05. Between WTA and DA sites, there was no statistically significant difference. Histological analysis also confirmed more new bone formation at WTA and DA sites. Conclusions: Rather than disposing extracted human teeth as a biomedical waste (common practice, they can be collected from suitable systemically healthy donors. With the help of tissue bank, they can be processed into an allograft, serving as an

  9. Comparative Alveolar Ridge Preservation Using Allogenous Tooth Graft versus Free-dried Bone Allograft: A Randomized, Controlled, Prospective, Clinical Pilot Study.

    Science.gov (United States)

    Joshi, Chaitanya Pradeep; D'Lima, Cynthia Bernardo; Samat, Urmila Chandrashekhar; Karde, Prerna Ashok; Patil, Agraja Ganpat; Dani, Nitin Hemchandra

    2017-01-01

    For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA) in alveolar ridge preservation. Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases). Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL), mineralized whole tooth allograft (WTA) and dentin allograft (DA) were prepared using the standard protocol of Tissue Bank at Tata Memorial Hospital, Mumbai, India. In this randomized controlled trial, 15 patients undergoing extraction of at least four teeth were selected. In each patient after atraumatic extractions, one socket was grafted with WTA, second with DA, third with FDBA, and fourth was left ungrafted (control site). All the sites were covered with chorion membrane. To estimate three-dimensional alveolar crest changes, cone beam computed tomography scans were taken immediately after grafting and 4 months postoperatively. Bone biopsies using 3 mm trephine bur were obtained from four patients at the time of implant placement and evaluated histologically. Clinically uneventful healing was observed at all sites. Compared to other sites, WTA and DA consistently showed superior results demonstrating least reduction in alveolar crest height and width which was statistically significant (P < 0.05). Between WTA and DA sites, there was no statistically significant difference. Histological analysis also confirmed more new bone formation at WTA and DA sites. Rather than disposing extracted human teeth as a biomedical waste (common practice), they can be collected from suitable systemically healthy donors. With the help of tissue bank, they can be processed into an allograft, serving as an excellent alternative to conventional allografts.

  10. Is there a role for hyberbaric oxygen as primary treatment for grade IV radiation-induced haemorrhagic cystitis? a prospective pilot-feasibility study and review of literature

    Directory of Open Access Journals (Sweden)

    Athanasios Dellis

    2014-06-01

    Full Text Available Purpose To examine the safety and efficacy of hyperbaric oxygen as the primary treatment for Grade IV radiation-induced haemorrhagic cystitis. Materials and Methods Hyperbaric oxygen was prospectively applied as a primary treatment option in 11 patients with Grade IV radiation cystitis. Primary endpoint was the incidence of complete and partial response to treatment. Secondary endpoints included the duration of response, the correlation of treatment success-rate to the interval between the onset of haematuria and initiation of therapy, blood transfusion need and total radiation dose, the number of sessions to success, the avoidance of surgery and the overall survival. Results All patients completed therapy without complications for a mean follow-up of 17.82 months (range 3 to 34. Mean number of sessions needed was 32.8 (range 27 to 44. Complete and partial response rate was 81.8% and 18.2%, respectively. However, in three patients the first treatment session was not either sufficient or durable giving a 72.7% rate of durable effect. Interestingly, all 9 patients with complete response received therapy within 6 months of the haematuria onset compared to the two patients with partial response who received therapy at 8 and 10 months from the haematuria onset, respectively (p = 0.018. The need for blood transfusion (p = 0.491 and the total radiation dose (p = 0.259 were not correlated to success-rate. One patient needed cystectomy, while all patients were alive at the end of follow-up. Conclusions Early primary use of hyperbaric oxygen to treat radiation-induced grade IV cystitis is an effective and safe treatment option.

  11. Atrial Fibrillation Screening in Nonmetropolitan Areas Using a Telehealth Surveillance System With an Embedded Cloud-Computing Algorithm: Prospective Pilot Study.

    Science.gov (United States)

    Chen, Ying-Hsien; Hung, Chi-Sheng; Huang, Ching-Chang; Hung, Yu-Chien; Hwang, Juey-Jen; Ho, Yi-Lwun

    2017-09-26

    Atrial fibrillation (AF) is a common form of arrhythmia that is associated with increased risk of stroke and mortality. Detecting AF before the first complication occurs is a recognized priority. No previous studies have examined the feasibility of undertaking AF screening using a telehealth surveillance system with an embedded cloud-computing algorithm; we address this issue in this study. The objective of this study was to evaluate the feasibility of AF screening in nonmetropolitan areas using a telehealth surveillance system with an embedded cloud-computing algorithm. We conducted a prospective AF screening study in a nonmetropolitan area using a single-lead electrocardiogram (ECG) recorder. All ECG measurements were reviewed on the telehealth surveillance system and interpreted by the cloud-computing algorithm and a cardiologist. The process of AF screening was evaluated with a satisfaction questionnaire. Between March 11, 2016 and August 31, 2016, 967 ECGs were recorded from 922 residents in nonmetropolitan areas. A total of 22 (2.4%, 22/922) residents with AF were identified by the physician's ECG interpretation, and only 0.2% (2/967) of ECGs contained significant artifacts. The novel cloud-computing algorithm for AF detection had a sensitivity of 95.5% (95% CI 77.2%-99.9%) and specificity of 97.7% (95% CI 96.5%-98.5%). The overall satisfaction score for the process of AF screening was 92.1%. AF screening in nonmetropolitan areas using a telehealth surveillance system with an embedded cloud-computing algorithm is feasible.

  12. Laparo-Endoscopic Single-Site Surgery for Radical and Cytoreductive Nephrectomy, Renal Vein Thrombectomy, and Partial Nephrectomy: A Prospective Pilot Evaluation

    Directory of Open Access Journals (Sweden)

    Ithaar H. Derweesh

    2010-01-01

    Full Text Available Introduction. Laparo-endoscopic single-site surgery (LESS may diminish morbidity of laparoscopic surgery. We prospectively evaluated feasibility and outcomes of LESS-Radical Nephrectomy (LESS-RN and Partial Nephrectomy (LESS-PN. Methods. 10 patients underwent LESS-RN (6 and LESS-PN (4 between 2/2009-5/2009. LESS-RN included 2 with renal vein thrombectomy, one of which was also cytoreductive. Transperitoneal LESS access was obtained by periumbilical incision. Patient/tumor characteristics, oncologic, and quality of life (QoL outcomes were analyzed. Results. 3 Men/7 Women (mean age 58.7 years, median follow-up 9.8 months underwent LESS. 9/10 cases were completed successfully. All had negative margins. Mean operative time was 161 minutes, estimated blood loss was 125 mL, and incision size was 4.4 cm. Median tumor size for LESS-RN and -PN was 5.0 and 1.7 cm (=.045. Median LESS-PN ischemia time was 24 minutes; mean preoperative/postoperative creatinine were 0.7/0.8 mg/dL (=.19. Mean pain score at discharge was 1.3. Mean preoperative, 3-, and 6-month postoperative SF-36 QoL Score was 73.8, 74.4 and 77.1 (=.222. All patients are currently alive. Conclusions. LESS-RN, renal vein thrombectomy, and PN are technically feasible and safe while maintaining adherence to oncologic principles, with excellent QoL preservation and low discharge pain scores. Further study is requisite.

  13. A prospective pilot cohort analysis of crash characteristics and pattern of injuries in riders and pillion passengers involved in motorcycle crashes in an urban area in Cameroon: lessons for prevention.

    Science.gov (United States)

    Chichom-Mefire, Alain; Atashili, Julius; Tsiagadigui, Jean G; Fon-Awah, Clovis; Ngowe-Ngowe, Marcelin

    2015-09-18

    Low and middle-income countries carry over ninety per cent of the burden of injury related mortality and disability. Motorcycles are gradually becoming a major mode of transportation in Cameroon and other African countries in the absence of an organized public transport. Consequently, the contribution of motorcycle crash to injury-related deaths seems to be on the rise. Currently, data addressing motorcycle crash characteristics, pattern, and severity of motorcycle-related injuries in Cameroon are scarce. We hypothesised that head and limb injuries are the most frequent cause of morbidity and mortality and equally affect riders and pillion passengers. This hospital-based prospective pilot cohort analysis involving 405 motorcycle crashes and 621 injury victims was conducted in Laquintinie Hospital, a large centre located in an urban area in Cameroon. All motorcycle riders and passengers received in the emergency department over a 4 months period with an injury following a traffic related crash were included. Crash characteristics and type, anatomical location and severity of injuries were recorded and analysed comparing the pattern of injuries between riders and pillion passengers involved in motorcyclecrashes. This pilot analysis is expected to propose a snapshot of motorcycle injuries in Douala and will be followed by a larger analysis over a longer period. We recorded a majority of motorcycle versus car and motorcycle versus motorcycle collisions. Most of these crashes occurred over the week-end and in the night. Helmet use was almost inexistent. We observed that females aged above 40 years represented the majority of pillion passengers. This accounted for the sex-ratio of 1.1/1. A total of 1311 injuries were identified in our patients, giving a mean of 2.1 injuries per victim. The head and the limbs were the most affected anatomical areas. Riders carried a higher risk of sustaining an injury to head and neck than pillion passengers. Riders and pillion passengers

  14. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.;

    2012-01-01

    implementation and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can be difficult...

  15. The Second Opening of the Waste Isolation Pilot Plant? Review of Salient Characteristics and Unique Operational Considerations for Remote Handled Transuranic Waste

    Energy Technology Data Exchange (ETDEWEB)

    Anastas, G.; Walker, B.A.

    2003-02-24

    The U.S. Department of Energy (DOE) intends to dispose of remote handled (RH) transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) beginning in 2005. (1) Four principle regulatory agencies are involved in the process of approving the RH TRU waste activities. The DOE is responsible for operational activities. The U. S. Nuclear Regulatory Commission (NRC) approves the design and use of shipping containers. The U.S. Environmental Protection Agency (EPA) is responsible for assuring safe and environmentally effective long-term disposal of the radioactive component of the waste and operational environmental monitoring. The New Mexico Environment Department (NMED) is responsible for the handling and the disposal of the non-radioactive hazardous component of the waste. The Environmental Evaluation Group (EEG) is responsible for performing independent technical oversight of all WIPP activities, and will comment on documents and practices for the various regulated RH TRU waste activities. The DOE has already obtained the necessary approvals from the NRC, and has submitted a Class 3 Modification request to the NMED. On December 16, 2002 the DOE Carlsbad Field Office (CBFO) provided the EPA with a notice of proposed change, in accordance with 40 CFR 194.4 (b) (3), to receive and dispose of remote handled transuranic waste. (2) WIPP procedures for the management of RH TRU waste at the site are being developed. While there are no issues with current NRC Certificates of Compliance for the RH TRU waste shipping containers, it is likely that there will be some controversy over other aspects of the currently planned RH TRU waste program. These issues may include: (1) the published RH TRU waste inventory, (2) the characterization of the radionuclide portion of the waste, for which one planned method is to use dose-to-Curie conversions, and (3) the plans to use bounding estimates for the hazardous portion of the WIPP waste, rather than measuring VOCs on a container

  16. The role of 3-D ultrasonography in the evaluation of menstrual cycle-related vascular modifications of the clitoris. A prospective pilot study.

    Science.gov (United States)

    Battaglia, Cesare; Nappi, Rossella Elena; Sisti, Giovanni; Persico, Nicola; Busacchi, Paolo; Venturoli, Stefano

    2009-10-01

    Clitoral functional modifications occur during the menstrual cycle. To prospectively evaluate, by the three-dimensional (3-D) Doppler flow analysis, the hemodynamic clitoral blood flow variations during the menstrual cycle. METHODS. Fourteen young (18-35 years), eumenorrheic (menstrual cycle of >25 and 1 year) and without any sexual dysfunction (as resulted from the two-factor Italian McCoy female sexuality questionnaire > or =35) were submitted, in the early follicular (day 3-5) and in the periovulatory (day 12-14) phases of the menstrual cycle, to bi- and tridimensional ultrasonographic and color Doppler analyses of the clitoral structures. On the same days, the circulating estradiol values were assayed. MAIN OUTCOMES MEASURES. Two-dimensional ultrasonographic evaluation of follicular diameter and color Doppler evaluation of the dorsal clitoral arteries; 3-D power Doppler analysis of the clitoral body volume and of the indices of clitoral vascularization and blood flow; estradiol assay. The mean virtual organ computer-aided analysis (VOCAL) volume of the clitoral body was lower in the follicular (0.79 +/- 0.19 mL) phase with respect to the periovulatory phase (0.98 +/- 0.22 mL; P < 0.001); the clitoral arteries demonstrated a significant decrease of the pulsatility index (PI) from the follicular (1.75 +/- 0.18) to the periovulatory phase (1.26 +/- 0.21; P = 0.002); the 3-D power Doppler histogram analysis showed significant changes of the indices of vascularization and blood flow (vascularization index [VI] = 2.239 +/- 1.201 vs. 3.302 +/- 1.305, P = 0.001; flow index = 27.290 +/- 2.454 vs. 33.620 +/- 1.712, P < 0.001; vascularization flow index = 0.578 +/- 0.573 vs. 1.091 +/- 0.461; P = 0.001) between the follicular and the periovulatory phase of the menstrual cycle. The relationship between the different parameters evidenced that estradiol is positively correlated with the VOCAL clitoral body volume (r = 0.512; P = 0.033) and inversely correlated with the dorsal

  17. Demonstrating the effectiveness of body armour: a pilot prospective computerised surface wound mapping trial performed at the Role 3 hospital in Afghanistan.

    Science.gov (United States)

    Breeze, Johno; Allanson-Bailey, L S; Hepper, A E; Midwinter, M J

    2015-03-01

    Modern body armour clearly reduces injury incidence and severity, but evidence to actually objectively demonstrate this effect is scarce. Although the Joint Theatre Trauma Registry (JTTR) alone cannot relate injury pattern to body armour coverage, the addition of computerised Surface Wound Mapping (SWM) may enable this utility. Surface wound locations of all UK and NATO coalition soldiers, Afghan National Army and Police and local nationals injured by explosively propelled fragments and treated in the Role 3 UK-led Field Hospital in Camp Bastion, Afghanistan, between 8 July and 20 October 2012 were prospectively recorded. The Abbreviated Injury Scores (AIS) and relative risk of casualties sustaining injuries under a type of body armour were compared with those that did not wear that armour. Casualties wearing a combat helmet were 2.7 times less likely to sustain a fragmentation wound to the head than those that were unprotected (mean AIS of 2.9 compared with 4.1). Casualties wearing a body armour vest were 4.1 times less likely to sustain a fragmentation wound to the chest or abdomen than those that were unprotected (mean AIS of 2.9 compared with 3.9). Casualties wearing pelvic protection were 10 times less likely to sustain a fragmentation wound to the pelvis compared with those that were unprotected (mean AIS of 3.4 compared with 3.9). Computerised SWM has objectively demonstrated the ability of body armour worn on current operations in Afghanistan to reduce wound incidence and severity. We recognise this technique is limited in that it only records the surface wound location and may be specific to this conflict. However, gathering electronic SWM at the same time as recording injuries for the JTTR was simple, required little extra time and therefore we would recommend its collection during future conflicts. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  18. Pilot Implementations

    DEFF Research Database (Denmark)

    Manikas, Maria Ie

    tensions and negotiations are fundamental characteristics of pilot implementations. Based on the analysis of a project that is pilot implementing an electronic pre-hospital patient record for emergency medical services in Danish health care, I investigate other perceptions of pilot implementations....... The analysis is conducted by means of a theoretical framework that centres on the concept infrastructure. With infrastructure I understand the relation between organised practice and the information systems supporting this practice. Thus, infrastructure is not a thing but a relational and situated concept...... understanding of pilot implementations as enacted interventions into existing infrastructures. Moreover, being embedded in the day-to-day organisation of work pilot implementations intervenes in the conventions of practice making the taken for granted visible. This allows project participants to attend...

  19. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.

    2012-01-01

    A recurrent problem in information-systems development (ISD) is that many design shortcomings are not detected during development, but first after the system has been delivered and implemented in its intended environment. Pilot implementations appear to promise a way to extend prototyping from...... the laboratory to the field, thereby allowing users to experience a system design under realistic conditions and developers to get feedback from realistic use while the design is still malleable. We characterize pilot implementation, contrast it with prototyping, propose a iveelement model of pilot...... implementation and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can be difficult...

  20. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.

    2012-01-01

    A recurrent problem in information-systems development (ISD) is that many design shortcomings are not detected during development, but first after the system has been delivered and implemented in its intended environment. Pilot implementations appear to promise a way to extend prototyping from...... the laboratory to the field, thereby allowing users to experience a system design under realistic conditions and developers to get feedback from realistic use while the design is still malleable. We characterize pilot implementation, contrast it with prototyping, propose a five-element model of pilot...... implementation, and provide three empirical illustrations of our model. We conclude that pilot implementation has much merit as an ISD technique when system performance is contingent on context. But we also warn developers that, despite their seductive conceptual simplicity, pilot implementations can...

  1. Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation : A prospective randomised controlled trial [ISRCTN51857546

    NARCIS (Netherlands)

    M.P. Arts (Mark); W.C. Peul (Wilco); R. Brand (René); B.W. Koes (Bart); R.T.W.M. Thomeer (Raph)

    2006-01-01

    textabstractBackground: Open discectomy is the standard surgical procedure in the treatment of patients with long-lasting sciatica caused by lumbar disc herniation. Minimally invasive approaches such as microendoscopic discectomy have gained attention in recent years. Reduced tissue trauma allows ea

  2. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Ali Jendoubi

    2017-01-01

    Conclusion: Ketamine and lidocaine are safe and effective adjuvants to decrease opioid consumption and control early pain. We also suggest that lidocaine infusion serves as an interesting alternative to improve the functional walking capacity and prevent chronic neuropathic pain at 3 months after open nephrectomy.

  3. Blonanserin Augmentation of Atypical Antipsychotics in Patients with Schizophrenia-Who Benefits from Blonanserin Augmentation?: An Open-Label, Prospective, Multicenter Study

    National Research Council Canada - National Science Library

    Woo, Young Sup; Park, Joo Eon; Kim, Do-Hoon; Sohn, Inki; Hwang, Tae-Yeon; Park, Young-Min; Jon, Duk-In; Jeong, Jong-Hyun; Bahk, Won-Myong

    2016-01-01

    ...) with augmentation by blonanserin in schizophrenic patients. aA total of 100 patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP were recruited in this 12-week, open-label, non-comparative, multicenter study...

  4. A newly designed radiation therapy protocol in combination with prednisolone as treatment for meningoencephalitis of unknown origin in dogs: a prospective pilot study introducing magnetic resonance spectroscopy as monitor tool.

    Science.gov (United States)

    Beckmann, Katrin; Carrera, Inés; Steffen, Frank; Golini, Lorenzo; Kircher, Patrick R; Schneider, Uwe; Bley, Carla Rohrer

    2015-01-31

    A plethora of treatment options have been described for canine meningoencephalitis of unknown origin (MUO), yet a gold standard has not been established. The aim of this prospective pilot study was to document the effect of a newly designed 30 Gray (Gy) radiation therapy (RT) protocol plus corticosteroids as treatment for focal and multifocal MUO, to monitor clinical and imaging changes during the course of the disease with conventional magnetic resonance imaging (MRI) and proton MR Spectroscopy (H-1 MRS) and to detect the occurrence of radiation related side effects. Six dogs (3 with focal and 3 with multifocal lesions) were included in the study. The RT protocol used consisted of 30 Gy in 10 fractions. The neurological status of all six dogs improved during RT, with 3 of 6 cases returning to a normal condition. One dog was euthanized early during follow-up (<3 weeks after end of RT). Three month follow up MRI was normal in one dog and improved in 3 dogs and H-1 MRS normalized in 4. In the dog without improvement of the MRI lesions, the N-acetyl aspartate continued to decrease, while choline and creatine concentrations remained stable during that time. This dog was euthanized 18 month after the end of RT due to relapse. One dog was lost to follow up 12 month after completion of RT. The other 3 dogs are still alive at the time of writing. RT with 30 Gy in 10 fractions can provide an additional option for anti-inflammatory treatment of focal and multifocal MUO. The protocol used for treatment monitoring was feasible while no side effects of RT could be observed during the follow up period. Moreover, H-1 MRS could represent a new and non-invasive tool to control the progression of the disease during the treatment course.

  5. Transurethral intraprostatic injection of botulinum neurotoxin type A for the treatment of chronic prostatitis/chronic pelvic pain syndrome: results of a prospective pilot double-blind and randomized placebo-controlled study.

    Science.gov (United States)

    Falahatkar, Siavash; Shahab, Elaheh; Gholamjani Moghaddam, Keivan; Kazemnezhad, Ehsan

    2015-10-01

    To evaluate the effect of botulinum neurotoxin type-A (BoNT-A) on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) refractory to medical therapy. Between November 2011 and January 2013, 60 men aged ≥18 years with CP/CPPS, and with National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) scores ≥10 and pain subscale scores ≥8, who were refractory to 4-6 weeks' medical therapy, underwent transurethral intraprostatic injection of BoNT-A or normal saline in a prospective pilot double-blind randomized study. The patients' NIH-CPSI total and subscale scores, American Urological Association (AUA)-symptom score (SS), visual analogue scale (VAS) and quality of life (QoL) scores and frequencies of diurnal and nocturnal urination were evaluated and compared at baseline and at 1, 3 and 6 months after injection and also were compared between the two groups. A total of 60 consecutive patients were randomized to a BoNT-A (treatment) or normal saline (placebo) group. In the treatment group at the 1-, 3- and 6-month evaluation the NIH-CPSI total and subscale scores, and the AUA-SS, VAS and QoL scores, along with frequencies of diurnal and nocturnal urinations, had significantly improved compared with baseline values (P patients developed mild transient gross haematuria, which was managed conservatively. Transurethral intraprostatic BoNT-A injection maybe an effective therapeutic option in patients with CP/CPPS as it reduces pain and improves QoL. © 2014 The Authors. BJU International © 2014 BJU International Published by John Wiley & Sons Ltd.

  6. Long-Term Results of Mini-Open Repair Technique in the Treatment of Acute Achilles Tendon Rupture: A Prospective Study.

    Science.gov (United States)

    Taşatan, Ersin; Emre, Tuluhan Yunus; Demircioğlu, Demet Tekdöş; Demiralp, Bahtiyar; Kırdemir, Vecihi

    2016-01-01

    An ideal surgical treatment of acute Achilles tendon rupture includes restoring the original length of the tendon, minimizing possible adhesions with the surrounding tissues, minimizing the risk of repeat rupture, alleviating wound problems, and providing an acceptable cosmetic outcome. In the mini-open repair technique, unlike the percutaneous repair technique, the quality of the tenodesis can be visualized without disturbing the healing potential of the surrounding tissues, thus minimizing wound problems. The purpose of the present study was to assess the long-term results of the mini-open repair technique in patients with acute Achilles tendon rupture. A total of 20 consecutive patients with acute Achilles tendon rupture, admitted to our inpatient clinic from October 2003 to March 2008, were included in the present study. The patients underwent Achilles tenodesis with the mini-open repair technique, and each patient was followed up for 5 years. The study was completed in April 2013. The surgical procedure was performed with the assistance of a device designed in our orthosis laboratories, similarly to that defined by Assal et al. Of the 20 patients, 18 were male and 2 were female. Their mean age was 39.3 (range 21 to 55) years. The Achilles tendon rupture was located on the left side in 15 patients (75%) and on the right side in 5 patients (25%). The mean follow-up duration was 58.5 (range 18 to 60) months and no complications occurred during the follow-up period, including repeat rupture, wound site infection, and sural nerve injury. The mean American Orthopaedic Foot and Ankle Society scale score for the patients was 99.2 (range 94 to 100) points at the final follow-up visit. All our patients were able to return to work and sporting activities. According to the Trillat scores, the outcome was excellent in 19 patients and good in 1 patient at the 18th postoperative month. No complaint, such as pain or loss of function, that might have a negative effect on the

  7. Nonimmersive virtual reality mirror visual feedback therapy and its application for the treatment of complex regional pain syndrome: an open-label pilot study.

    Science.gov (United States)

    Sato, Kenji; Fukumori, Satoshi; Matsusaki, Takashi; Maruo, Tomoko; Ishikawa, Shinichi; Nishie, Hiroyuki; Takata, Ken; Mizuhara, Hiroaki; Mizobuchi, Satoshi; Nakatsuka, Hideki; Matsumi, Masaki; Gofuku, Akio; Yokoyama, Masataka; Morita, Kiyoshi

    2010-04-01

    Chronic pain conditions such as phantom limb pain and complex regional pain syndrome are difficult to treat, and traditional pharmacological treatment and invasive neural block are not always effective. Plasticity in the central nervous system occurs in these conditions and may be associated with pain. Mirror visual feedback therapy aims to restore normal cortical organization and is applied in the treatment of chronic pain conditions. However, not all patients benefit from this treatment. Virtual reality technology is increasingly attracting attention for medical application, including as an analgesic modality. An advanced mirror visual feedback system with virtual reality technology may have increased analgesic efficacy and benefit a wider patient population. In this preliminary work, we developed a virtual reality mirror visual feedback system and applied it to the treatment of complex regional pain syndrome. A small open-label case series. Five patients with complex regional pain syndrome received virtual reality mirror visual feedback therapy once a week for five to eight sessions on an outpatient basis. Patients were monitored for continued medication use and pain intensity. Four of the five patients showed >50% reduction in pain intensity. Two of these patients ended their visits to our pain clinic after five sessions. Our results indicate that virtual reality mirror visual feedback therapy is a promising alternative treatment for complex regional pain syndrome. Further studies are necessary before concluding that analgesia provided from virtual reality mirror visual feedback therapy is the result of reversing maladaptive changes in pain perception.

  8. Omega-3 fatty acids in the management of autism spectrum disorders: findings from an open-label pilot study in Singapore.

    Science.gov (United States)

    Ooi, Y P; Weng, S-J; Jang, L Y; Low, L; Seah, J; Teo, S; Ang, R P; Lim, C G; Liew, A; Fung, D S; Sung, M

    2015-08-01

    The goal of this open-label trial was to examine the efficacy and safety of a 12-week omega-3 fatty acids supplementation among children suffering with Autism Spectrum Disorders (ASD). A total of 41 children and adolescents aged 7-18 years (36 boys, 5 girls; mean age = 11.66, s.d. = 3.05) diagnosed with ASD participated in the study. At post-treatment, participants showed significant improvements on all subscales of the Social Responsiveness Scale (P fatty acid levels were significantly correlated with changes in the core symptoms of ASD. Baseline levels of blood fatty acid levels were also predictive of response to the omega-3 treatment. Omega-3 fatty acids supplementation was well-tolerated and did not cause any serious side effects. Our findings lend some preliminary support for the use of omega-3 fatty acids supplementation in addressing ASD. Future randomized controlled trials of omega-3 fatty acids in ASD with blood fatty acid measurements with a larger sample and longer follow-up period is warranted.

  9. In Vitro Comparative Evaluation of Different Types of Impression Trays and Impression Materials on the Accuracy of Open Tray Implant Impressions: A Pilot Study.

    Science.gov (United States)

    Gupta, Sonam; Narayan, Aparna Ichalangod; Balakrishnan, Dhanasekar

    2017-01-01

    Purpose. For a precise fit of multiple implant framework, having an accurate definitive cast is imperative. The present study evaluated dimensional accuracy of master casts obtained using different impression trays and materials with open tray impression technique. Materials and Methods. A machined aluminum reference model with four parallel implant analogues was fabricated. Forty implant level impressions were made. Eight groups (n = 5) were tested using impression materials (polyether and vinylsiloxanether) and four types of impression trays, two being custom (self-cure acrylic and light cure acrylic) and two being stock (plastic and metal). The interimplant distances were measured on master casts using a coordinate measuring machine. The collected data was compared with a standard reference model and was statistically analyzed using two-way ANOVA. Results. Statistically significant difference (p materials. However, the difference seen was small (36 μm) irrespective of the tray type used. No significant difference (p > 0.05) was observed between varied stock and custom trays. Conclusions. The polyether impression material proved to be more accurate than vinylsiloxanether impression material. The rigid nonperforated stock trays, both plastic and metal, could be an alternative for custom trays for multi-implant impressions when used with medium viscosity impression materials.

  10. Recent Ⅳ-drug users with chronic hepatitis C can be efficiently treated with daily high dose induction therapy using consensus interferon: An open-label pilot study

    Institute of Scientific and Technical Information of China (English)

    Th Witthoeft; M Fuchs; D Ludwig

    2007-01-01

    AIM: To investigate the use of high dose consensusinterferon in combination with ribavirin in former iv drug users infected with hepatitis C.METHODS: We started, before pegylated (PEG)interferons were available, an open-label study to investigate the efficacy and tolerability of high dose induction therapy with consensus interferon (CIFN) and ribavirin in treatment of naiive patients with chronic hepatitis C. Fifty-eight patients who were former iv drug users, were enrolled receiving 18 μg of CIFN daily for 8 wk, followed by 9 μg daily for up to wk 24 or 48 and 800 mg of ribavirin daily. End point of the study was tolerability and eradication of the virus at wk 48 and sustained virological response at wk 72.RESULTS: More than 62% of patients responded to the treatment with CIFN at wk 24 or 48, respectively,showing a negative qualitative PCR [genotype 1 fourteen patients (56%), genotype 2 five (50%),genotype 3 thirteen (87%), genotype 4 four (50%)].Forty-eight percent of genotype 1 patients showed sustained virological response (SVR) six months after the treatment.CONCLUSION: CIFN on a daily basis is well tolerated and side effects like leuko- and thrombocytopenia are moderate. End of therapy (EOT) rates are slightly lower than the newer standard therapy with pegylated interferons. CIFN on a daily basis might be a favourable therapy regimen for patients with GT1 and high viral load or for non-responders after failure of standard therapy.

  11. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial

    OpenAIRE

    Koes Bart W; Arts Mark P; Brand Ronald; Peul Wilco C; Brouwer Patrick A; Berg Annette; van Buchem Mark A

    2009-01-01

    Abstract Background The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness...

  12. Renal access in PNL under sonographic guidance: Do we really need to insert an open end ureteral catheter in dilated renal systems? A prospective randomized study.

    Science.gov (United States)

    Eryildirim, Bilal; Tuncer, Murat; Camur, Emre; Ustun, Fatih; Tarhan, Fatih; Sarica, Kemal

    2017-10-03

    To evaluate the true necessity of open end ureteral catheter insertion in patients with moderate to severe pelvicalyceal system dilation treated with percutaneous nephrolithotomy (PNL) under sonographic guidance. 50 cases treated with PNL under sonographic guidance in prone position for solitary obstructing renal stones were evaluated. Patients were randomly divided into two groups; Group 1: Patients in whom a open end ureteral catheter was inserted prior to the procedure; Group 2: Patients receiving no catheter before PNL. In addition to the duration of the procedure as a whole and also all relevant stages as well, radiation exposure time, hospitalization period, mean nephrostomy tube duration, mean drop in Hb levels and all intra and postoperative complications have been evaluated. Mean size of the stones was 308.5 ± 133.2 mm2. Mean total duration of the PNL procedure in cases with open end ureteral catheter was significantly longer than the other cases (p < 0.001). Evaluation of the outcomes of the PNL procedures revealed no statistically significant difference between two groups regarding the stone-free rates (86% vs 84%). Additionally, there was no significant difference with respect to the duration of nephrostomy tube, hospitalization period and secondary procedures needed, complication rates as well as the post-operative Hb drop levels in both groups (p = 0.6830). Our results indicate that the placement of an open end ureteral catheter prior to a PNL procedure performed under sonographic access may not be indicated in selected cases presenting with solitary obstructing renal pelvic and/or calyceal stones.

  13. The Review and Prospect of Open Innovation Research%国内外开放式创新研究动态与展望

    Institute of Scientific and Technical Information of China (English)

    何郁冰

    2015-01-01

    开放式创新是指企业在技术创新过程中通过与外部组织的广泛合作,整合内外部创新资源进而提高创新效率与效益的一类创新模式。该现象已经引起中外学者的共同关注,研究内容涉及开放式创新的内涵界定、类型及模式、对竞争优势的影响、决策影响因素及管理策略等。纵观国内外开放式创新研究,在理论探讨、实证研究、外向开放式创新、开放的风险与成本、基于中国情境的研究等方面存在着不足,应当成为今后开放式创新研究的重要内容。%Open innovation stands for an innovation mode in which enterprises improve innovation performance through making broad cooperation with external organizations and integrating external resources with internal inter-nal resources in the process of technological innovation. The phenomenon has already aroused attention and re-searches from scholars all over the world. The contents including the definition, categories and modes, impaction on competitiveness, management strategy, and research method. Summarizing current researches, there are some shortages among them. Such as theoretical studies, empirical research, outbound opens innovation, the risk and cost of open innovation, Chinese context-based research and so on. These problems should have being important contents in later open innovation researches.

  14. Pilot implementation

    DEFF Research Database (Denmark)

    Hertzum, Morten; Bansler, Jørgen P.; Havn, Erling C.

    2012-01-01

    A recurrent problem in information-systems development (ISD) is that many design shortcomings are not detected during development, but first after the system has been delivered and implemented in its intended environment. Pilot implementations appear to promise a way to extend prototyping from...... the laboratory to the field, thereby allowing users to experience a system design under realistic conditions and developers to get feedback from realistic use while the design is still malleable. We characterize pilot implementation, contrast it with prototyping, propose a five-element model of pilot...

  15. An open pilot study of zonisamide augmentation in major depressive patients not responding to a low dose trial with duloxetine: preliminary results on tolerability and clinical effects

    Directory of Open Access Journals (Sweden)

    Benvenuti Marzia

    2011-09-01

    Full Text Available Abstract Background Despite multiple antidepressant options, major depressive disorder (MDD still faces high non-response rates, eventually requiring anticonvulsant augmentation strategies too. The aim of this study was to explore such a potential role for zonisamide. Methods A total of 40 MDD outpatients diagnosed using the Diagnostic and Statistical Manual for Mental Disorders, fourth edition criteria entered a 24 week open trial receiving duloxetine 60 mg/day for the first 12 weeks and subsequently (weeks 12 to 24 augmentation with zonisamide 75 mg/day if they did not respond to the initial monotherapy. Efficacy and tolerability were assessed using the Hamilton Scales for Anxiety and Depression (a 12 week score ≥50% vs baseline defined 'non-response', the Arizona Sexual Experience Scale, the Patient Rated Inventory of Side Effects and the Young Mania Rating Scale. Results At week 12, 15 patients out of 39 (38.5% were responders, and 1 had dropped out; remarkably, 14 patients out of 24 (58.3% had achieved response by week 24. Poor concentration and general malaise were associated with non-response both at week 12 and 24 (P = 0.001, while loss of libido and reduced energy were prominent among final timepoint non-responders. Patients receiving zonisamide also experienced weight reduction (2.09 ± 12.14 kg; P = 0.001 independently of the outcome. Conclusions Although only a preliminary study due to strong methodological limitations, and thus requiring confirmation by further controlled investigations, the current results indicate zonisamide may be a potential augmentation option for some depressed patients receiving low doses of duloxetine.

  16. Duloxetine and care management treatment of older adults with comorbid major depressive disorder and chronic low back pain: results of an open-label pilot study

    Science.gov (United States)

    Karp, Jordan F.; Weiner, Debra K.; Dew, Mary A.; Begley, Amy; Miller, Mark D.; Reynolds, Charles F.

    2010-01-01

    Objective: In older adults, major depressive disorder (MDD) and chronic low back pain (CLBP) are common and mutually exacerbating. We predicted that duloxetine pharmacotherapy and Depression and Pain Care Management (DPCM) would result in (1) significant improvement in MDD and CLBP and (2) significant improvements in health-related quality of life, anxiety, disability, self-efficacy, and sleep quality. Design and Intervention: Twelve week open-label study using duloxetine up to 120 mg/day + DPCM. Setting: Outpatient late-life depression research clinic. Patients: Thirty community-dwelling adults >60 years old. Outcome Measures: Montgomery Asberg Depression Rating Scale (MADRS) and McGill Pain Questionnaire-Short Form (MPQ-SF). Results: 46.7% (n = 14) of the sample had a depression remission. All subjects who met criteria for the depression remission also had a pain response. 93.3% (n = 28) had a significant pain response. Of the subjects who met criteria for a low back pain response, 50% (n = 14) also met criteria for the depression remission. The mean time to depression remission was 7.6 (SE = 0.6) weeks. The mean time to pain response was 2.8 (SE = 0.5) weeks. There were significant improvements in mental health-related quality of life, anxiety, sleep quality, somatic complaints, and both self-efficacy for pain management and for coping with symptoms. Physical health-related quality of life, back pain-related disability, and self-efficacy for physical functioning did not improve. Conclusions: Serotonin and norepinephrine reuptake inhibitors like duloxetine delivered with DPCM may be a good choice to treat these linked conditions in older adults. Treatments that target low self-efficacy for physical function and improving disability may further increase response rates. PMID:19750557

  17. 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;

  18. Assessing sleeping energy expenditure in children using heart-rate monitoring calibrated against open-circuit indirect calorimetry: a pilot study.

    Science.gov (United States)

    Beghin, L; Michaud, L; Guimber, D; Vaksmann, G; Turck, D; Gottrand, F

    2002-11-01

    Total energy expenditure (EE) can be assessed in children by the heart-rate (HR) monitoring technique calibrated against open-circuit indirect calorimetry (IC). In this technique, sleeping EE is usually estimated as the lowest value of a 30 min resting EE measurement x 0 x 90 to give an average for the total sleeping period. However, sleeping is a dynamic process in which sleeping EE is modulated by the effect of factors such as body movement and different sleep stages. The aim of the present study was to determine a new method to improve the sleeping EE measurement by taking into account body movements during sleep. Twenty-four non-obese children participated in the present study. All subjects passed through a calibration period. HR and EE measured by IC were simultaneously collected during resting, the postprandial period, and during different levels of activity. Different methods for computing sleeping EE (resting with different breakpoints ('flex point' HR with linear regression or 'inflection point' (IP) HR with the third order polynomial regression equation (P3)) were compared with EE measured for least 2.0 h in eight sleeping children. The best method of calculation was then tested in sixteen children undergoing HR monitoring and with a body movement detector. In a subset of eight children undergoing simultaneous sleeping EE measurement by IC and HR, the use of the equation resting when HRIP during the sleeping period gave the lowest difference (1 (sd 5.4) %) compared with other methods (linear or polynomial regressions). The new formula was tested in an independent subset of sixteen other children. The difference between sleeping EE computed with the formula resting and sleeping EE computed with resting when HRIP during sleeping periods was significant (13 (sd 5.9) %) only for active sleeping subjects (n 6 of 16 subjects). The correlation between the difference in the results from the two methods of calculation and body movements was close (r 0

  19. Effectiveness of MIS technique as a treatment modality for open intra-articular calcaneal fractures: A prospective evaluation with matched closed fractures treated by conventional technique.

    Science.gov (United States)

    Dhillon, Mandeep Singh; Gahlot, Nitesh; Satyaprakash, Sambit; Kanojia, Rajendra Kumar

    2015-09-01

    Twenty-five displaced intra-articular calcaneal fractures in 21 patients, aged 15-55 years were included in this study. Sanders' type I fractures, severe crushing or partial amputation, were excluded from the study. Patients were divided into group 1 (open fractures treated by MIS), and group 2 (closed fractures treated by ORIF). Group 1 had 16 and group 2 had 9 cases. Seven of 25 fractures (28%) developed wound related issues postoperatively. One patient (11.1%) in group 2 had wound margin necrosis, while 6 patients (37.5%) in group 1 developed pin tract and/or wound infection. At 1-year follow-up, the mean MFS for group 1 was 79 and mean MFS for group 2 was 84.4 (66.67% were good). The AOFAS score for group 1 was 77.37 and for group 2 was 86.1. The Bohlers' angle was restored in 81.16% cases in group 1 and 88.8% in group 2, while Gissane angle was restored in 68.75% of group 1 cases and 77.79% of group 2 cases. This study shows that acceptable fracture reduction can be obtained and maintained by MIS technique and it can be used as the primary definitive treatment option in open calcaneal fractures. Copyright © 2015 Elsevier Ltd. All rights reserved.

  20. From consumer to prosumer: Enrolling users into a Norwegian PV pilot

    DEFF Research Database (Denmark)

    Throndsen, William; Skjølsvold, Tomas Moe; Ryghaug, Marianne

    2017-01-01

    a closer look at the status of prosumers as they are enrolled by a local Norwegian utility into a solar PV pilot. Combined with an escalating focus on digital technologies across the energy system, the idea of the prosumer has opened for much experimentation with socio-technical solutions including novel...... business models. A shift is occurring from traditional, one-way centralized energy provision to a model of distributed energy production flowing bi-directionally. This paper is an in-depth look into a socio-technical innovation process of this kind, tracking implementation of solar PV in a Norwegian pilot...... the power company attempts to enroll customers, while prospective customers attempt to enroll the power company. We also study the moment of installation of PV panels in households, by observing the encounter between installer and customer. This is a potentially critical moment of translation...

  1. A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch

    DEFF Research Database (Denmark)

    Berrevoet, Frederik; Doerhoff, Carl; Muysoms, Filip

    2017-01-01

    open ventral hernia repair with the PCO-VP was performed. Patient outcomes were assessed at discharge and at 10 days, 1, 6, 12, and 24 months postoperative. RESULTS: All patients had hernioplasty for umbilical (n = 110, 87.3%) or epigastric hernia (n = 16, 12.7%). Mean hernia diameter was 1.8 ± 0.8 cm....... Mean operative time was 36.2 ±15.6 minutes, with a mean mesh positioning time of 8.1 ± 3.4 minutes. Surgeons reported satisfaction with mesh ease of use in 95% of surgeries. The cumulative hernia recurrence rate at 1 year was 2.8% (3/106). Numeric Rating Scale (NRS) pain scores showed improvement from...... laparoscopic...

  2. A prospective, controlled evaluation of the abdominal reapproximation anchor abdominal wall closure system in combination with VAC therapy compared with VAC alone in the management of an open abdomen.

    Science.gov (United States)

    Long, Kristin L; Hamilton, David A; Davenport, Daniel L; Bernard, Andrew C; Kearney, Paul A; Chang, Phillip K

    2014-06-01

    Dramatic increases in damage control and decompressive laparotomies and a significant increase in patients with open abdominal cavities have resulted in numerous techniques to facilitate fascial closure. We hypothesized addition of the abdominal reapproximation anchor system (ABRA) to the KCI Abdominal Wound Vac™ (VAC) or KCI ABThera™ would increase successful primary closure rates and reduce operative costs. Fourteen patients with open abdomens were prospectively randomized into a control group using VAC alone (control) or a study group using VAC plus ABRA (VAC-ABRA). All patients underwent regular VAC changes; patients receiving VAC-ABRA also underwent concomitant daily elastomer adjustment of the ABRA system. Primary end points included abdominal closure, number of operating room (OR) visits, and OR time use. Eight patients were included in the VAC-ABRA group and six patients in the control group. Primary closure rates between groups were not statistically different; however, the number of trips to the OR and OR time use were different. Despite higher Acute Physiology and Chronic Health Evaluation II scores, larger starting wound size, and higher rates of abdominal compartment syndrome, closure rates in the VAC-ABRA group were similar to VAC alone. Importantly, however, fewer OR trips and less OR time were required for the VAC-ABRA group.

  3. Registro Absorb Italiano (BVS-RAI): an investigators-owned and -directed, open, prospective registry of consecutive patients treated with the Absorb™ BVS: study design.

    Science.gov (United States)

    Cortese, Bernardo; Ielasi, Alfonso; Varricchio, Attilio; Tarantini, Giuseppe; LaVecchia, Luigi; Pisano, Francesco; Facchin, Michela; Gistri, Roberto; D'Urbano, Maurizio; Lucci, Valerio; Loi, Bruno; Tumminello, Gabriele; Colombo, Alessandro; Limbruno, Ugo; Nicolino, Annamaria; Calzolari, Diego; Tognoni, Gianni; Defilippi, Gianfranco; Buccheri, Dario; Tespili, Maurizio; Corrado, Donatella; Steffenino, Giuseppe

    2015-09-01

    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. 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 5years. 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. 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. Copyright © 2015 Elsevier Inc. All rights reserved.

  4. Chronic calcifying tendinitis of the shoulder-therapy by percutaneous needle aspiration and lavage: a prospective open study of 62 shoulders.

    Science.gov (United States)

    Pfister, J; Gerber, H

    1997-05-01

    In an open study the therapeutic value of percutaneous needle aspiration and lavage performed in local anaesthesia under image intensifier control in patients with chronic calcifying shoulder tendinitis was investigated. 60 patients (62 shoulders) were included in the study. The average age was 48 years, and the median duration of shoulder pain and calcification was 24 months and 7 months respectively. The right shoulder was affected in 34 and the left in 24 patients; two patients had painful calcifications in both shoulders. In 47% X-ray showed calcium deposits in the contralateral shoulder. 77% of the painful deposits projected on the supraspinatus tendon and in most cases image intensifier examination showed multiple calcifications. Calcareous material could be removed by needle aspiration and lavage in 76% of all cases. There was no correlation regarding the preferred working hand and the side of calcifying tendinitis. X-ray controls performed after 2 months revealed a significant reduction of the size of calcifications. The clinical follow-up 2 and 6 months after needling showed a significant reduction of global pain intensity. There were also significant improvements in the areas of pain on movement, pain at night and impairment of sleep. Clinical success was independent of the radiological aspect of the calcifications.

  5. [What is the situation with human rights of the elderly? : UN Open-ended Working Group on Ageing - review and prospects].

    Science.gov (United States)

    Mahler, Claudia

    2017-06-01

    In November 2010 the United Nations General Assembly set up a working group to strengthen the protection of human rights for older persons (UN Open-ended Working Group on Ageing) with the United Nations Resolution A/C.3/65/L.8/Rev.1. In December 2016 the members of the working group met for the seventh time and discussed how they can approach the fulfillment of the mandate. In addition to better implementation, the strengthening of rights can consist of closing existing gaps or further differentiation of the rights in order to give the member states better guidance on how to implement them. To improve the human rights of older persons a task of the members of the working group would be to examine the existing rights and, where possible, adjust them to the real needs of the group. One of the major challenges facing the working group is already apparent: who belongs to the group of older persons and how could the group be described? This article deals with the presentation of the international process, new developments at the regional level and the attitudes of the member states and the civil society. A further aim is to present the possibilities and effects of a comprehensive legally binding instrument.

  6. Blonanserin Augmentation of Atypical Antipsychotics in Patients with Schizophrenia-Who Benefits from Blonanserin Augmentation?: An Open-Label, Prospective, Multicenter Study.

    Science.gov (United States)

    Woo, Young Sup; Park, Joo Eon; Kim, Do-Hoon; Sohn, Inki; Hwang, Tae-Yeon; Park, Young-Min; Jon, Duk-In; Jeong, Jong-Hyun; Bahk, Won-Myong

    2016-07-01

    The purpose of this study was to investigate the efficacy and tolerability of atypical antipsychotics (AAPs) with augmentation by blonanserin in schizophrenic patients. aA total of 100 patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP were recruited in this 12-week, open-label, non-comparative, multicenter study. Blonanserin was added to their existing AAP regimen, which was maintained during the study period. Efficacy was primarily evaluated using the Positive and Negative Syndrome Scale (PANSS) at baseline and at weeks 2, 4, 8, and 12. Predictors for PANSS response (≥20% reduction) were investigated. The PANSS total score was significantly decreased at 12 weeks of blonanserin augmentation (-21.0±18.1, F=105.849, pblonanserin occurred in 17 patients (17.0%); 4 of these patients dropped out due to adverse events. The patients who benefited the most from blonanserin were those with severe symptoms despite a treatment with a higher dose of AAP. Blonanserin augmentation could be an effective strategy for patients with schizophrenia who were partially or completely unresponsive to treatment with an AAP.

  7. Efficacy of single-injection unilateral thoracic paravertebral block for post open cholecystectomy pain relief: a prospective randomized study at Gondar University Hospital

    Science.gov (United States)

    Fentie, Demeke Yilkal; Gebremedhn, Endale Gebreegziabher; Denu, Zewditu Abdissa; Gebreegzi, Amare Hailekiros

    2017-01-01

    Background Cholecystectomy can be associated with considerable postoperative pain. While the benefits of paravertebral block (PVB) on pain after thoracotomy and mastectomy have been demonstrated, not enough investigations on the effects of PVB on pain after open cholecystectomy have been conducted. We tested the hypothesis that a single-injection thoracic PVB reduces pain scores, decreases opioid consumption, and prolongs analgesic request time after cholecystectomy. Methods Of 52 patients recruited, 50 completed the study. They were randomly allocated into two groups: the paravertebral group and the control group. The outcome measures were the severity of pain measured on numeric pain rating scale, total opioid consumption, and first analgesic request time during the first postoperative 24 hours. Result The main outcomes recorded during 24 hours after surgery were Numerical Rating Scale (NRS) pain scores (NRS, 0–10), cumulative opioid consumption, and the first analgesic request time. Twenty four hours after surgery, NRS at rest was 4 (3–6) vs 5 (5–7) and at movement 4 (4–7) vs 6 (5–7.5) for the PVB and control groups, respectively. The difference between the groups over the whole observation period was statistically significant (Ptramadol consumption was 200 (150–250) mg vs 300 (200–350) mg in the paravertebral and in the control group, respectively (P=0.003). After surgery, the median (25th–75th percentile) first analgesic requirement time was prolonged in the PVB group in statistically significant fashion (P<0.0001). Conclusion and recommendations Single-shot thoracic PVB as a component of multi-modal analgesic regimen provided superior analgesia when compared with the control group up to 24 postoperative hours after cholecystectomy, and we recommend this block for post cholecystectomy pain relief. PMID:28744155

  8. INFLUENCE OF GRADED AEROBIC EXERCISE ON QUALITY OF LIFE IN POST SURGICAL MITRAL VALVE DISEASE INDIVIDUAL A PROSPECTIVE RANDOMIZED OPEN LABEL STUDY

    Directory of Open Access Journals (Sweden)

    Shanthi C

    2016-10-01

    Full Text Available Background: Post surgical mitral valve disease individual focus their cardiac rehabilitation training on two major goal that is to improve cardiac output response exercises and place an important role in determining exercise tolerance and to improve quality of life. Cardiac rehabilitation programs involve prescribed exercise and education however various other method are being used to improve quality of life. But our study to find out the effectiveness of graded aerobic exercise protocol on ejection fraction and quality of life in post surgical mitral valve disease individuals. Methods: The study design was open label studies total of 100 post surgical mitral valve disease individuals patients from the age group of 20-60 years were recruited from SVIMS hospital. They were randomly divided into two groups. Group I underwent a twelve week structured graded individually tailored exercises. The group II received only none graded (not individualized exercise training. The ejection fraction and quality of life was measured before and after 12 weeks of exercise training for two groups. Results: Repeated measures ANOVA was used to compare mean values of continuous variables between baseline and at the time of discharge and three months after surgery for each parameter. Comparison of means between groups was done by the unpaired student t test. Mean age of the subjects was 40.18±10.29. There was a significant increase in the ejection fraction in the group I(61.34±2.49 to 64.4±3.31 compared to with the group II (61.06±2.51. to 61.62 ±2.37. QOL had improved in group I than group II at p<0.05. Conclusion: A 12 week structured graded aerobic exercise training significantly improved ejection fraction and quality of life in post surgical mitral valve disease individuals.

  9. Efficacy and tolerability of escitalopram in treatment of major depressive disorder with anxiety symptoms: a 24-week, open-label, prospective study in Chinese population

    Science.gov (United States)

    Jiang, Kaida; Li, Lingjiang; Wang, Xueyi; Fang, Maosheng; Shi, Jianfei; Cao, Qiuyun; He, Jincai; Wang, Jinan; Tan, Weihao; Hu, Cuili

    2017-01-01

    Background Significant anxiety symptoms are associated with poor clinical course and outcome in major depressive disorder (MDD). This single-arm, open-label study aimed to evaluate the efficacy and tolerability of escitalopram treatment in patients with MDD and anxiety symptoms. Methods Adult patients with MDD and anxiety symptoms (Montgomery–Asberg Depression Rating Scale [MADRS] ≥22 and Hamilton Anxiety Rating Scale [HAM-A] ≥14) were enrolled and received escitalopram (10–20 mg/day) treatment for 24 weeks. Symptom status was assessed by MADRS, 17-item-Hamilton Depression Rating Scale, HAM-A, and Clinical Global Impression Scale at baseline and the following visits. Quality of life was assessed by Short Form-12, and safety was evaluated by adverse events, laboratory investigations, vital signs, and physical findings. Results Overall, 200 of 318 (66.2%) enrolled patients completed the 24-week treatment. The remission (MADRS ≤10 and HAM-A ≤7) rate in the full analysis set (N=285) was 73.3% (95% confidence interval: 67.80, 78.38) at week 24. Mean (± standard deviation) MADRS total score was 33.4 (±7.13) and HAM-A score was 27.6 (±7.26) at baseline, which reduced to 6.6 (±10.18) and 6.0 (±8.39), respectively, at week 24. Patients with higher baseline depression and anxiety level took longer to achieve similar remission rates. Overall, 80 of the 302 (26.5%) patients included in the safety set reported at least 1 treatment-emergent adverse event (TEAE). Most frequently reported TEAEs (>2%) were headache (4.0%), nasopharyngitis (3.6%), nausea (3.0%), and dizziness (2.6%). Serious TEAEs were reported by 1.3% patients; no deaths were reported. Conclusion Escitalopram 10–20 mg/day was effective and well-tolerated in the long-term treatment of MDD with anxiety symptoms in adult Chinese population. PMID:28255239

  10. A multi-center, prospective, open-label, 8-week study of certoparin for anticoagulation during maintenance hemodialysis – the membrane study

    Directory of Open Access Journals (Sweden)

    Dorsch Oliver

    2012-06-01

    Full Text Available Abstract Background Adequate anticoagulation is prerequisite for effective hemodialysis to prevent clotting in the extracorporeal circuit. We aimed providing first data on the efficacy and safety of the low-molecular-weight heparin certoparin in this setting. Methods Multicenter, open-label, 8-week trial. Patients received a single dose of 3,000 IU certoparin i.v. with additional titration steps of 600 IU and/or continuous infusion if necessary. Results 120 patients were screened, 109 enrolled (median age 71; range 26–90 years and 106 available for efficacy analyses. The percentage of unsatisfactory dialysis results at 8 weeks due to clotting or bleeding, was 1.9% (n = 2/106; 95% confidence interval [CI] 0.23–6.65%; no major bleeding. 1.9% had moderate/severe clotting in the lines/bubble catcher and 2.8% in the dialyser at week 8. 15.7 ± 14.3% of the dialysis filters’ visual surface area was showing redness. In subgroups of patients receiving median doses of 3000 ± 0, 3000 (2400–6000 and 4200 (3000–6600 IU, plasma aXa levels at baseline, 4 and 8 weeks were 0.24 [95%CI 0.21–0.27], 0.33 [0.27–0.40] and 0.38 [0.33–0.45] aXa IU/ml at 2 h. C48h was 0.01 [0.01–0.02] aXa IU at all visits. At baseline and 4 weeks AUC0-48h was 2.66 [2.19–3.24] and 3.66 [3.00–4.45] aXa IU*h/ml. In 3.0% of dialyses (n = 83/2724 prolonged fistula compression times were documented. Eight patients (7.34% had at least one episode of minor bleeding. 4 85.3% of patients had any adverse event, 9.2% were serious without suspected drug relation; and in 32 patients a drug-relation was suspected. Conclusions Certoparin appears effective and safe for anticoagulation in patients undergoing maintenance hemodialysis.

  11. Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

    Science.gov (United States)

    Fea, Antonio M; Belda, Jose I; Rękas, Marek; Jünemann, Anselm; Chang, Lydia; Pablo, Luis; Voskanyan, Lilit; Katz, L Jay

    2014-01-01

    Purpose The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject® trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol. Patients and methods Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject® devices in the treated eye and 98 to receive medical therapy. Results At the month 12 visit, 94.7% of eyes (89/94) in the stent group reported an unmedicated intraocular pressure (IOP) reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98) in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02) at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94) in the iStent inject group and 89.8% of eyes (88/98) in the medical therapy group. Mean (standard deviation) IOP decreases from screening of 8.1 (2.6) mmHg and 7.3 (2.2) mmHg were reported in the iStent inject and medical therapy groups, respectively. A high safety profile was also noted in this study in both the iStent inject and medical therapy groups, as measured by stable best corrected visual acuity, cup-to-disc ratio, and adverse events. Conclusion These data show that the use of iStent inject is at least as effective as two medications, with the clinical benefit of reducing medication burden and assuring continuous treatment with full compliance to implant therapy as well as having a highly favorable safety profile. PMID:24855336

  12. Pilot Greenhouse

    CERN Multimedia

    1983-01-01

    This pilot greenhouse was built in collaboration with the "Association des Maraichers" of Geneva in the frame of the study for making use of the heat rejected as warm water by CERN accelerators and experiments. Among other improvements, more automated and precise regulation systems for heating and ventilation were developed. See also 8305598X.

  13. Efficacy and tolerability of escitalopram in treatment of major depressive disorder with anxiety symptoms: a 24-week, open-label, prospective study in Chinese population

    Directory of Open Access Journals (Sweden)

    Jiang KD

    2017-02-01

    Full Text Available Kaida Jiang,1 Lingjiang Li,2 Xueyi Wang,3 Maosheng Fang,4 Jianfei Shi,5 Qiuyun Cao,6 Jincai He,7 Jinan Wang,8 Weihao Tan,8 Cuili Hu8 1Psychiatry Department, Shanghai Mental Health Center, Shanghai, 2Psychiatry Department,The Second Xiangya Hospital, Central South University, Changsha, 3Psychiatry Department, First affiliated Hospital of Hebei Medical University, Shijiazhuang, 4Psychiatry Department, Wuhan Mental Health Center, Wuhan, 5Psychiatry Department, Hangzhou the 7th Hospital, Hangzhou, 6Psychology Department, Nanjing Drum Tower Hospital, Nanjing, 7Neurology Department, First affiliated Hospital of Wenzhou Medical University, Wenzhou, 8Medical Affairs Department, Xi’an Janssen Pharmaceutical Ltd., Beijing, People’s Republic of China Background: Significant anxiety symptoms are associated with poor clinical course and outcome in major depressive disorder (MDD. This single-arm, open-label study aimed to evaluate the efficacy and tolerability of escitalopram treatment in patients with MDD and anxiety symptoms. Methods: Adult patients with MDD and anxiety symptoms (Montgomery–Asberg Depression Rating Scale [MADRS] ≥22 and Hamilton Anxiety Rating Scale [HAM-A] ≥14 were enrolled and received escitalopram (10–20 mg/day treatment for 24 weeks. Symptom status was assessed by MADRS, 17-item-Hamilton Depression Rating Scale, HAM-A, and Clinical Global Impression Scale at baseline and the following visits. Quality of life was assessed by Short Form-12, and safety was evaluated by adverse events, laboratory investigations, vital signs, and physical findings. Results: Overall, 200 of 318 (66.2% enrolled patients completed the 24-week treatment. The remission (MADRS ≤10 and HAM-A ≤7 rate in the full analysis set (N=285 was 73.3% (95% confidence interval: 67.80, 78.38 at week 24. Mean (± standard deviation MADRS total score was 33.4 (±7.13 and HAM-A score was 27.6 (±7.26 at baseline, which reduced to 6.6 (±10.18 and 6.0 (±8

  14. Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

    Directory of Open Access Journals (Sweden)

    Fea AM

    2014-05-01

    Full Text Available Antonio M Fea,1 Jose I Belda,2 Marek Rękas,3 Anselm Jünemann,4 Lydia Chang,5 Luis Pablo,6 Lilit Voskanyan,7 L Jay Katz81Università degli Studi di Torino, Clinica Oculistica, Torino, Italy; 2Hospital Torrevieja Salud, UTE, Servicio de Oftalmologia, Alicante, Spain; 3Military Institute of Medicine, Department of Ophthalmology, Warsaw, Poland; 4Universitätsaugenklinik, Erlangen, Germany; 5Hinchingbrooke Hospital NHS Trust and Moorfields Bedford Hospital NHS Trust, United Kingdom; 6Hospital Universitario Miguel Servet, Servicio Oftalmologico, Zaragoza, Spain; 7SV Malayan Ophthalmological Center, Yerevan, Armenia; 8Wills Eye Institute, Jefferson Medical College, Philadelphia, PA, USAPurpose: The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG not controlled on one medication who underwent either implantation of two iStent inject® trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol.Patients and methods: Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject® devices in the treated eye and 98 to receive medical therapy.Results: At the month 12 visit, 94.7% of eyes (89/94 in the stent group reported an unmedicated intraocular pressure (IOP reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98 in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02 at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94 in the iStent inject group and 89.8% of eyes (88/98 in the medical therapy group. Mean (standard deviation IOP decreases from screening of 8.1 (2.6 mmHg and 7.3 (2.2 mmHg were reported in the iStent inject and medical therapy groups, respectively. A high

  15. Prospective, randomized study of one, two, or three trabecular bypass stents in open-angle glaucoma subjects on topical hypotensive medication

    Directory of Open Access Journals (Sweden)

    Katz LJ

    2015-12-01

    Full Text Available L Jay Katz,1 Carl Erb,2 Amadeu Carceller Guillamet,3 Antonio M Fea,4 Lilit Voskanyan,5 Jeffrey M Wells,6 Jane Ellen Giamporcaro6 1Wills Eye Hospital, Jefferson Medical College, Philadelphia, PA, USA; 2Eye Clinic Wittenbergplatz, Berlin, Germany; 3Department of Ophthalmology, Hospital d’Hebron, Barcelona, Spain; 4University Eye Clinic of the University of Turin, Turin, Italy; 5SV Malayan Opthalmology Centre, Yerevan, Armenia; 6Glaukos Corporation, Laguna Hills, CA, USA Purpose: To assess the safety and efficacy of one, two, or three trabecular microbypass stents in eyes with primary open-angle glaucoma (OAG not controlled on ocular hypotensive medication. A total of 119 subjects were followed for 18 months postoperatively.Materials and methods: Subjects with medicated intraocular pressure (IOP 18–30 mmHg and postmedication-washout baseline IOP 22–38 mmHg were randomized to implantation of one, two, or three stents. Ocular hypotensive medication was to be used if postoperative IOP exceeded 18 mmHg.Results: A total of 38 subjects were implanted with one stent, 41 subjects with two stents, and 40 subjects with three stents. Both month 12 IOP reduction ≥20% without ocular hypotensive medication vs baseline unmedicated IOP and month 12 unmedicated IOP ≤18 mmHg were achieved by 89.2%, 90.2%, and 92.1% of one-, two-, and three-stent eyes, respectively. Furthermore, 64.9%, 85.4%, and 92.1% of the three respective groups achieved unmedicated IOP ≤15 mmHg. Over the 18-month follow-up period, medication was required in seven one-stent subjects, four two-stent subjects, and three three-stent subjects. At 18 months, mean unmedicated IOP was 15.9±0.9 mmHg in one-stent subjects, 14.1±1.0 mmHg in two-stent subjects, and 12.2±1.1 mmHg in three-stent subjects. Month 18 IOP reduction was significantly greater (P<0.001 with implantation of each additional stent, with mean differences in reduction of 1.84 mmHg (95% confidence interval 0.96

  16. Open environmental data sets - prospect of co-operation between public and private sector in water quality monitoring. Final report of Water Quality Service for Lakes -project; Avoin ympaeristoetieto - yhteistyoen kehittaeminen vesistoejen seurannassa. Jaervien vedenlaatupalvelu -hankkeen loppuraportti

    Energy Technology Data Exchange (ETDEWEB)

    Anttila, S.; Broeckl, M.; Herlevi, A. (and others)

    2012-04-15

    Data sets collected by the public sector are common property and should be freely available. Effective usage of this open data is anticipated to create new information and services, but also to develop welfare for humans. Insufficient usage of public and open environmental data sets in the private sector has been recognized as a problem. Reasons for this can be found from the non-commercial nature of environmental data, the way it is collected and archived, but also from the strong role of public sector in this field. In the Water Quality Service for Lakes -project (Tekes, 2009-2012), we wanted to advance the utilization of the public data sets in the private sector, as well as to promote the co-operation between these two sectors. Starting point was to develop local research infrastructure in the way that collected information would be easily accessible to private companies. This was realized by creating a data base that gathers water quality information from several data sources and provides a standardized interface for the data utilization. In addition, project provided a variety of research results including a questionnaire survey targeted to the users of water quality information, and the methods to increase the accuracy of collected data and to create forecasts from it. A concrete result from the project was also the development of 'laymans' water quality measurement device named as Secchi3000. A digital camera installed in e.g. mobile phones can be used with Secchi3000 device to measure water quality of different natural waters. This new innovation has great potential in e.g. citizen based monitoring. The challenges and opportunities to create business based on the public environmental data were revolved in two work shops. In this publication the prospects of co-operation between public and private sector are discussed based on the results of the Water Quality Service for lakes -project. (orig.)

  17. A prospective case-control study of extralevator abdominoperineal excision (ELAPE) of the rectum versus conventional laparoscopic and open abdominoperineal excision: comparative analysis of short-term outcomes and quality of life.

    Science.gov (United States)

    Vaughan-Shaw, P G; Cheung, T; Knight, J S; Nichols, P H; Pilkington, S A; Mirnezami, A H

    2012-10-01

    Conventional abdominoperineal excision (APE) of the rectum is associated with higher circumferential resection margin (CRM) involvement, increased local recurrence, and reduced survival compared to anterior resection. A more radical extralevator APE (ELAPE) technique may improve oncological outcome. However, this technique may confer additional morbidity, and little comparative data on short-term outcomes have been reported. This study compares short-term outcomes and quality of life (QOL) after open and laparoscopic ELAPE, laparoscopic APE (LAPE), and open APE (OAPE). Data on all ELAPE and 10 consecutive LAPE and OAPE were extracted from a prospective database. Perioperative care and follow-up were standardized. QOL was assessed using EORTC questionnaires. Sixteen ELAPE (14 laparoscopic), 10 LAPE, and 10 OAPE were included. Demographics, tumour stage, and neoadjuvant therapy use were comparable. Operative time was higher with ELAPE than LAPE and OAPE (295, 207.5, and 157.5 min, respectively, p = 0.01). A porcine collagen perineal mesh was used in 9 patients undergoing ELAPE but in no LAPE or OAPE patients. No difference in 30-day complications, re-admission, or length of stay was noted. ELAPE and LAPE were associated with earlier removal of urinary catheter (p = 0.02), yet other enhanced recovery after surgery (ERAS) parameters were equivalent. All ELAPE resections were R0 with no positive CRM identified. One LAPE and 2 OAPE were R1 resections. Analysis revealed no deterioration in QOL with ELAPE, with equivalent global health status. The results of this study suggest that ELAPE is not associated with deterioration in short-term outcomes or QOL when compared with LAPE or OAPE.

  18. 北斗在远海工程人员安全监管中的应用前景%Application prospect of BeiDou Navigation Satellite System in staff safety supervision of open- sea engineering

    Institute of Scientific and Technical Information of China (English)

    何建波; 张工; 崔银秋; 田俊峰

    2015-01-01

    北斗卫星导航系统是中国正在实施的自主发展、独立运行的全球卫星导航系统,作为先进的导航、定位、测量和授时手段,已经融入了国家建设和社会发展的各个应用领域。文章根据北斗系统的服务特色和服务优势,阐述北斗在远海工程人员安全监管的技术解决途径和应用前景,进行了有益的尝试。%China is implementing the BeiDou Navigation Satellite System, which is the independently developed and operated global navigation satellite system by China. It has been integrated into various applications of the national construction and so-cial development as the means of navigation, fixed position, measurement, and time service. Based on the service characteristics and advantages of BeiDou System, we describes the technology solutions and application prospect of BeiDou System in staff safety supervision of open-sea engineering, and carried on the beneficial attempt.

  19. Prospective comparative study of laparoscopic-assisted and open radical gastrectomy for gastric cancer%胃癌腹腔镜与开腹手术的前瞻性对照临床研究

    Institute of Scientific and Technical Information of China (English)

    岑庆; 张军; 蔡军; 吴国聪; 金岚; 王康里; 张忠涛

    2013-01-01

    Objective Through the prospective comparative study of laparoscopic-assistcd and open radical gastrectomy for gastric cancer,to evaluate the safety,feasibility,radical and postoperative short-term efficacy of laparoscopic-assisted gastrectomy.Methods From May 2010 to December 2011,29 gastric cancer patients matching the inclusion criteria were chosen as the laparoscopic group.According to the same inclusion criteria,29 gastric cancer patients with the same or similar clinical T stage (AJCC 7th edition) were extracted as the open group.Then the two groups information was carried out a comparative study.Results The mean operation time of the laparoscopic group was longer[(210.34 ± 44.76) min vs (151.55 ± 42.28) min,P =0.000] and the mean hospitalization costs were higher[(61 251 ±17 226) yuan vs (52 016 ±27 767) yuan,P=0.000],while the mean incision length was shorter[(5.83 ± 1.10) cm vs (15.93 ± 1.39) cm,P =O.000] than the open group.There was no significant difference on blood loss,of dissected lymph nodes number,proximal and distal resection margins,the first flatus time,the first liquid diet time,postoperative hospital stay,postoperative complications and cumulative survival rates between the two groups.Conclusion The laparoscopic-assisted gastrectomy for gastric cancer is safe and feasible,can achieve equivalent radical and short-term efficacy with the open surgery.%目的 通过对胃癌腹腔镜与开腹手术的前瞻性对照临床研究,评估前者的安全可行性、根治性及术后近期疗效.方法 2010年8月-2011年12月,选择符合人选标准的胃癌患者29例列为腹腔镜组,同时按照同一入组标准选择相同或相似临床T分期(AJCC第7版)的胃癌患者29例作为开腹对照组,对以上两组进行对比研究.结果 腹腔镜组手术时间长于开腹组[(210.34 ±44.76) min vs (151.55±42.28) min,P=0.000],住院总费用高于开腹组[(61 251±17 226)元vs(52 016 ±27 767)元,P=0.000],切口长度小于开腹组[(5

  20. Open, Prospective, Multi-Center, Two-Part Study of Patient Preference with Monthly Ibandronate Therapy in Women with Postmenopausal Osteoporosis Switched From Daily or Weekly Alendronate or Risendronate-BONCURE: Results of Turkish Sub-Study

    Directory of Open Access Journals (Sweden)

    Nurten Eskiyurt

    2012-04-01

    Full Text Available Aim: BONCURE (Bonviva for Current Bisphosphonate Users Regional European Trial, aimed to evaluate patient preference with monthly ibandronate in women with postmenopausal osteoporosis who previously received daily or weekly alendronate or risendronate. Materials and Methods: This prospective, open-label study consisted of two sequential stages, Part A (screening and Part B (treatment. Patients enrolled into Part A completed the Candidate Identification Questionnaire (CIQ. In Part B, after completing the Osteoporosis Patient Satisfaction Questionnaire (OPSATQ, patients received monthly oral ibandronate 150 mg for 6 months. Following treatment, patients completed the OPSAT-Q and Preference Questionnaire. Results: A total of 223 patients (mean age, 63.7±9.51 years were enrolled in Part A from Turkey. Among them, 103 (46.2% answered “YES” to at least one CIQ question. The mean composite OPSAT-Q domain scores increased for convenience (mean change, 15.3±17.7 points, quality of life (10.4±20.4 points, overall satisfaction (11.9±22.7 points, and side effects (3.3±18.8 points. At month 6, 177 subjects (92.7% preferred once-monthly dosing schedule and 99.0% were compliant (≥80% with study treatment. Thirty (15.6% subjects experienced mild to moderate adverse events, mostly gastrointestinal. Conclusion: Postmenopausal women with osteoporosis prefer and are more satisfied and compliant with monthly dosing of ibandronate than daily or weekly bisphosphonate treatment. (Turkish Journal of Osteoporosis 2012;18:1-7

  1. Effect of levitra on sustenance of erection (EROS): an open-label, prospective, multicenter, single-arm study to investigate erection duration measured by stopwatch with flexible dose vardenafil administered for 8 weeks in subjects with erectile dysfunction.

    Science.gov (United States)

    Shin, Y S; Lee, S W; Park, K; Chung, W S; Kim, S W; Hyun, J S; Moon, D G; Yang, S-K; Ryu, J K; Yang, D Y; Moon, K H; Min, K S; Park, J K

    2015-01-01

    To investigate the change of erection duration measured by stopwatch with flexible dose vardenafil administered for 8 weeks in subjects with erectile dysfunction (ED). Effect of levitra on sustenance of erection was an open-label, prospective, multicenter and single-arm study designed to measure the duration of erection in men with ED receiving a flexible dose of vardenafil over an 8-week treatment period. Patients were instructed to take vardenafil 10 mg 60 min before attempting the intercourse. Vardenfil could be increased to 20 mg or decreased to 5 mg concerning patients' efficacy and safety. Following the initial screening, patients entered a 4-week treatment-free run-in phase and 8-week treatment period, during which they were instructed to attempt intercourse at least four times on four separate days. A total of 95 men were enrolled in 10 centers. After the 8 weeks treatment, the mean duration of erection leading to successful intercourse was statistically superior when patients were treated with vardenafil. After an 8-week treatment, the duration of erection leading to successful intercourse was 9.39 min. There were significant benefits with vardenafil in all domains of International Index of Erectile Function. Secondary efficacy end points included success rate of penetration, maintaining erection, ejaculation and satisfaction were superior when patients were treated with vardenafil. There was a significant correlation between duration of erection with other sexual factors. Also partner's sexual satisfaction was increased with vardenafil. Most adverse events were mild or moderate in severity. Vardenafil was safe and well tolerated. Vardenafil therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED with female partner.

  2. Multicentre, prospective, randomised, open-label, blinded end point trial of the efficacy of allopurinol therapy in improving cardiovascular outcomes in patients with ischaemic heart disease: protocol of the ALL-HEART study

    Science.gov (United States)

    Ford, Ian; Walker, Andrew; Hawkey, Chris; Begg, Alan; Avery, Anthony; Taggar, Jaspal; Wei, Li; Struthers, Allan D; MacDonald, Thomas M

    2016-01-01

    Introduction Ischaemic heart disease (IHD) is one of the most common causes of death in the UK and treatment of patients with IHD costs the National Health System (NHS) billions of pounds each year. Allopurinol is a xanthine oxidase inhibitor used to prevent gout that also has several positive effects on the cardiovascular system. The ALL-HEART study aims to determine whether allopurinol improves cardiovascular outcomes in patients with IHD. Methods and analysis The ALL-HEART study is a multicentre, controlled, prospective, randomised, open-label blinded end point (PROBE) trial of allopurinol (up to 600 mg daily) versus no treatment in a 1:1 ratio, added to usual care, in 5215 patients aged 60 years and over with IHD. Patients are followed up by electronic record linkage and annual questionnaires for an average of 4 years. The primary outcome is the composite of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary outcomes include all-cause mortality, quality of life and cost-effectiveness of allopurinol. The study will end when 631 adjudicated primary outcomes have occurred. The study is powered at 80% to detect a 20% reduction in the primary end point for the intervention. Patient recruitment to the ALL-HEART study started in February 2014. Ethics and dissemination The study received ethical approval from the East of Scotland Research Ethics Service (EoSRES) REC 2 (13/ES/0104). The study is event-driven and results are expected after 2019. Results will be reported in peer-reviewed journals and at scientific meetings. Results will also be disseminated to guideline committees, NHS organisations and patient groups. Trial registration number 32017426, pre-results. PMID:27609859

  3. An open label prospective randomized trial to compare the efficacy of coal tar-salicylic acid ointment versus calcipotriol/betamethasone dipropionate ointment in the treatment of limited chronic plaque psoriasis

    Directory of Open Access Journals (Sweden)

    Sujay Khandpur

    2014-01-01

    Full Text Available Background: Chronic plaque psoriasis is a common papulosquamous skin disorder, for which a number of topical agents are being used including coal tar, topical steroids and more recently topical calcipotriol/betamethasone dipropionate. There is no study comparing purified coal tar preparation with calcipotriol/betamethasone dipropionate ointment in limited chronic plaque psoriasis. Aims and Objectives: A prospective randomized open label controlled trial to compare the efficacy and safety of topical application of coal tar-salicylic acid ointment with calcipotriol/betamethasone dipropionate ointment applied once at night for 12 weeks for the treatment of limited chronic plaque psoriasis. Materials and Methods: A total of 62 patients of limited chronic plaque psoriasis (body surface area <10% were randomized into two treatment groups: Group A received topical application of 6% coal tar with 3% salicylic acid ointment and Group B received calcipotriol/betamethasone dipropionate, once at night for 12 weeks. Results were assessed based on psoriasis area severity index (PASI scores and patient global assessment (PGA at each visit. Results: Mean PASI was significantly lower at week 2 (P = 0.01 and week 4 follow-up (P = 0.05 and the mean reduction in PASI was significantly higher at week 2 (P = 0.02 with calcipotriol/betamethasone than coal tar-salicylic acid, but this difference was not sustained at subsequent follow-up visits. Similarly, PGA scores at weeks 2 and 4 were significantly lower with calcipotriol/betamethasone dipropionate ointment (P = 0.003 and P = 0.007 respectively. There was no significant difference in any parameter during subsequent follow-up visits or at the end of the treatment phase (12 weeks. Conclusion: Topical nightly application of calcipotriol/betamethasone dipropionate ointment leads to an initial, more rapid reduction in disease severity, but the overall outcome parameters are comparable in the two treatment groups.

  4. Analysis of Pilot-Induced-Oscillation and Pilot Vehicle System Stability Using UAS Flight Experiments

    Directory of Open Access Journals (Sweden)

    Tanmay K. Mandal

    2016-11-01

    Full Text Available This paper reports the results of a Pilot-Induced Oscillation (PIO and human pilot control characterization study performed using flight data collected with a Remotely Controlled (R/C unmanned research aircraft. The study was carried out on the longitudinal axis of the aircraft. Several existing Category 1 and Category 2 PIO criteria developed for manned aircraft are first surveyed and their effectiveness for predicting the PIO susceptibility for the R/C unmanned aircraft is evaluated using several flight experiments. It was found that the Bandwidth/Pitch rate overshoot and open loop onset point (OLOP criteria prediction results matched flight test observations. However, other criteria failed to provide accurate prediction results. To further characterize the human pilot control behavior during these experiments, a quasi-linear pilot model is used. The parameters of the pilot model estimated using data obtained from flight tests are then used to obtain information about the stability of the Pilot Vehicle System (PVS for Category 1 PIOs occurred during straight and level flights. The batch estimation technique used to estimate the parameters of the quasi-linear pilot model failed to completely capture the compatibility nature of the human pilot. The estimation results however provided valuable insights into the frequency characteristics of the human pilot commands. Additionally, stability analysis of the Category 2 PIOs for elevator actuator rate limiting is carried out using simulations and the results are compared with actual flight results.

  5. The atrial fibrillation ablation pilot study

    DEFF Research Database (Denmark)

    Arbelo, Elena; Brugada, Josep; Hindricks, Gerhard

    2014-01-01

    AIMS: The Atrial Fibrillation Ablation Pilot Study is a prospective registry designed to describe the clinical epidemiology of patients undergoing an atrial fibrillation (AFib) ablation, and the diagnostic/therapeutic processes applied across Europe. The aims of the 1-year follow-up were to analyse...... tachycardia, and 4 patients died (1 haemorrhagic stroke, 1 ventricular fibrillation in a patient with ischaemic heart disease, 1 cancer, and 1 of unknown cause). CONCLUSION: The AFib Ablation Pilot Study provided crucial information on the epidemiology, management, and outcomes of catheter ablation of AFib...

  6. Primary medical therapy for acromegaly: an open, prospective, multicenter study of the effects of subcutaneous and intramuscular slow-release octreotide on growth hormone, insulin-like growth factor-I, and tumor size.

    Science.gov (United States)

    Bevan, J S; Atkin, S L; Atkinson, A B; Bouloux, P-M; Hanna, F; Harris, P E; James, R A; McConnell, M; Roberts, G A; Scanlon, M F; Stewart, P M; Teasdale, E; Turner, H E; Wass, J A H; Wardlaw, J M

    2002-10-01

    Conventional surgery and radiotherapy for acromegaly have limitations. There are few data on the use of the somatostatin analog octreotide (Oct) as primary medical therapy. An open prospective study of 27 patients with newly diagnosed acromegaly was conducted in nine endocrine centers in the United Kingdom. Twenty patients had macroadenomas, and 7 had microadenomas. For the first 24 wk (phase 1), patients received sc Oct in an initial dose of 100 microg, 3 times daily, increased to 200 micro g three times daily after 4 wk in the 13 patients whose mean serum GH remained greater than 5 mU/liter (2 microg/liter). Five-point GH profiles were performed at 0, 4, 12, and 24 wk, and high resolution pituitary imaging using a standard protocol was performed at 0, 12, and 24 wk (magnetic resonance imaging in 25 patients and computed tomography in 2). Tumor dimensions and volumes were calculated by a central, reporting neuroradiologist, and the results were audited by a second, independent neuroradiologist. After 24 wk, 15 patients proceeded to phase 2 of the study with a direct switch to monthly injections of the depot formulation of Oct, Sandostatin long-acting release (Oct-LAR). Further GH profiles were performed at 36 and 48 wk, and pituitary imaging was performed at 48 wk. The median pretreatment serum GH concentration was 30.7 mU/liter (range, 6.7-141.4). During sc Oct, serum GH fell to less than 5 mU/liter in 9 patients (38%), and IGF-I fell to normal in 8 patients (33%). All 27 tumors shrank during sc Oct; for microadenomas the median tumor volume reduction was 49% (range, 12-73), and for macroadenomas it was 43% (range, 6-92). After 24 wk of Oct-LAR (end of phase 2), the GH level was less than 5 mU/liter in 11 of 14 patients (79%), and IGF-I was normal in 8 of 15 patients (53%). In the 15 patients given Oct-LAR (10 macroadenomas), wk 48 scans showed a further overall median tumor volume reduction of 24%. At the end of the study 79% of patients had mean serum GH levels

  7. Accurate Detection of the Goaf of Gongchangling Open-pit Based on the Comprehensive Geophysical Prospecting Method%利用综合物探法精准探测弓长岭露天矿采空区

    Institute of Scientific and Technical Information of China (English)

    张德辉; 朱帝杰

    2015-01-01

    In order to detect the goaf of Gongchangling open-pit accurately,the comprehensive geophysical prospecting method based on high density resistivity method and transient electromagnetic method is proposed. Firstly,according to the high density resistivity method,the low resistance model and high resistance model of single goaf and double goaf under all kinds of geological conditions based on the detection data obtained by the devices of wenner,dipole array and unilateral tertiary,the goaf of Gongchangling open-pit distributed densely in horizontal and vertical direction is detected by conducting contrast analysis of the resistivity difference;secondly,based on transient electromagnetic method,the geological and geophysical recognition model of the same geological body are established by utilizing the devices of coincident loop,central loop,separate loop and ground loop,and the location and scale of the goaf of Guangchangling open-pit are detected accurately by observing the variation infor-mation of the transient magnetic field structure and frequency along with time and space;finally,in order to detect the informa-tion of location,scale and roof thickness with high precision,the comprehensive detection data of high density resistivity method and transient electromagnetic method are processed and interpreted comprehensively combing with the field actual geological conditions. The cross-section diagram and floor plan of the goaf of Gongchangling open-pit are obtained. The detection results show that 3 shallow goafs and 2 deep goafs are detected in Gongchangling open-pit,so it can be further indicated that the inte-gration of comprehensive and advantages of detecting technologies is realized by the organic combination of high density method and transient electromagnetic method. It is good to conduct the detection of goaf with high precision.%为了对弓长岭露天矿采空区进行精准探测,首先根据高密度电阻率法,利用温纳、偶极、单边三极

  8. PROSPECTING EXPLORATION

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    <正>20082879 Chen Yaoyu(No.3 Geology and Mineral Exploration Team,Gansu Provincial Bureau of Geology and Mineral Exploration and Development,Lanzhou 730050,China); Gong Quansheng Discussion on the Division of Deposit Scale and the Index of Ore Prospecting(Gansu Geology,ISSN 1004—4116,CN62—1191/P,16(3),2007,p.6—11,4 tables,6 refs.) Key words:prospecting and exploration of mineral

  9. Symptom-modifying effects of oral avocado/soybean unsaponifiables in routine treatment of knee osteoarthritis in Poland. An open, prospective observational study of patients adherent to a 6-month treatment

    Science.gov (United States)

    Głuszko, Piotr

    2016-01-01

    Objectives Observational studies provide insights into real-life situations. Therefore, we assessed the effects of oral avocado/soybean unsaponifiable (ASU) capsules on pain relief and functional ability in patients, while they were receiving a routine treatment for knee osteoarthritis (OA). Material and methods An open, prospective, observational 6-month study was conducted in 99 centers in Poland in a group of 4822 patients with symptomatic knee OA receiving one 300 mg ASU capsule/day as a routine medication. The patients had no diagnoses of other rheumatic diseases and were not treated with other symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). Data on OA symptoms and therapy were collected from the initiation of ASU treatment (visit 0) and during 3 consecutive control visits performed every 2 months (visits 1–3). Functional Lequesne index, severity of joint pain of one symptomatic knee (Laitinen index and VAS), use of analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), adherence to treatment and adverse events were evaluated and recorded using electronic Case Report Forms. Results Four thousand one hundred and eighty-six patients (86.8%) attended all 4 visits. In 94.2% of patients (mean age 60.7 ±11.6 years SD, 73.4% female) at least one OA risk factor was identified. There was a significant improvement in functional ability between the last and baseline visits as evidenced by the median Lequesne index decreasing from 8 to 4 points (p < 0.001). Measures of pain intensity also fell significantly (p < 0.001) throughout the study: median Laitinen score decreased from 6 to 3 points, median pain at rest VAS – from 1.8 to 0 cm and median pain during walking VAS – from 5.6 to 1.9 cm. The significant differences were also noted between consecutive visits. The proportion of patients using analgesics and NSAIDs declined from 58.8% at the baseline visit to 24.9% at the last visit 3 (p < 0.001). Defined daily dose of NSAIDs decreased

  10. An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder

    Institute of Scientific and Technical Information of China (English)

    Yi Zheng; Jian-Min Liang; Hong-Yun Gao; Zhi-Wei Yang; Fu-Jun Jia; Yue-Zhu Liang; Fang Fang

    2015-01-01

    Background: Attention-deficit hyperactivity disorder (ADHD) is the most common mental and behavioral disorder in school-aged children.This study evaluated the effect of osmotic-release oral system (OROS) methylphenidate (MPH) on cognitive function and academic performance of Chinese school-aged children with ADHD.Methods: This 12-week, prospective, multicenter, open-label, self-controlled study enrolled 153 Chinese school-aged children with ADHD and 41 non-ADHD children.Children with ADHD were treated with once-daily OROS-MPH (18 mg, 36 mg, or 54 mg).The primary endpoints were Inattention/Overactivity (I/O) with Aggression Conners Behavior Rating Scale (IOWA) and Digit Span Test at week 12 compared with baseline.Secondary endpoints included opposition/defiant (O/D) subscale of IOWA, Clinical Global Impression (CGI), Coding Test, Stroop Color-word Test, Wisconsin Card Sorting Test (WCST), academic performance on teacher-rated school examinations,and safety at week 12 compared with baseline.Both non-ADHD and ADHD children received the same frequency of cognitive operational test to avoid the possible bias caused by training.Results: A total of 128 patients were evaluated with cognitive assessments.The OROS-MPH treatment significantly improved IOWA Conners I/O subscale scores at week 12 (3.8 ± 2.3) versus baseline (10.0 ± 2.4;P < 0.0001).Digit Span Test scores improved significantly (P < 0.0001) with a high remission rate (81.1%) at week 12 versus baseline.A significant (P < 0.0001) improvement was observed in O/D subscale of IOWA, CGI, Coding Test, Stroop Color-word Test, WCST, and academic performance at week 12 versus baseline.Very few practice-related improvements were noticed in the non-ADHD group at week 12 compared with baseline.No serious adverse events and deaths were reported during the study.Conclusions: The OROS-MPH treatment effectively controlled symptoms of ADHD and significantly improved academic performance and cognitive function of Chinese

  11. An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder.

    Science.gov (United States)

    Zheng, Yi; Liang, Jian-Min; Gao, Hong-Yun; Yang, Zhi-Wei; Jia, Fu-Jun; Liang, Yue-Zhu; Fang, Fang; Li, Rong; Xie, Sheng-Nan; Zhuo, Jian-Min

    2015-11-20

    Attention-deficit hyperactivity disorder (ADHD) is the most common mental and behavioral disorder in school-aged children. This study evaluated the effect of osmotic-release oral system (OROS) methylphenidate (MPH) on cognitive function and academic performance of Chinese school-aged children with ADHD. This 12-week, prospective, multicenter, open-label, self-controlled study enrolled 153 Chinese school-aged children with ADHD and 41 non-ADHD children. Children with ADHD were treated with once-daily OROS-MPH (18 mg, 36 mg, or 54 mg). The primary endpoints were Inattention/Overactivity (I/O) with Aggression Conners Behavior Rating Scale (IOWA) and Digit Span Test at week 12 compared with baseline. Secondary endpoints included opposition/defiant (O/D) subscale of IOWA, Clinical Global Impression (CGI), Coding Test, Stroop Color-word Test, Wisconsin Card Sorting Test (WCST), academic performance on teacher-rated school examinations, and safety at week 12 compared with baseline. Both non-ADHD and ADHD children received the same frequency of cognitive operational test to avoid the possible bias caused by training. A total of 128 patients were evaluated with cognitive assessments. The OROS-MPH treatment significantly improved IOWA Conners I/O subscale scores at week 12 (3.8 ± 2.3) versus baseline (10.0 ± 2.4; P < 0.0001). Digit Span Test scores improved significantly (P < 0.0001) with a high remission rate (81.1%) at week 12 versus baseline. A significant (P < 0.0001) improvement was observed in O/D subscale of IOWA, CGI, Coding Test, Stroop Color-word Test, WCST, and academic performance at week 12 versus baseline. Very few practice-related improvements were noticed in the non-ADHD group at week 12 compared with baseline. No serious adverse events and deaths were reported during the study. The OROS-MPH treatment effectively controlled symptoms of ADHD and significantly improved academic performance and cognitive function of Chinese school-aged children with ADHD. The

  12. Does an Integrated Care Intervention for COPD Patients Have Long-Term Effects on Quality of Life and Patient Activation? A Prospective, Open, Controlled Single-Center Intervention Study

    Science.gov (United States)

    Bentsen, Signe Berit; Sunde, Synnøve; Steinshamn, Sigurd

    2017-01-01

    Background Implementation of the COPD-Home integrated disease management (IDM) intervention at discharge after hospitalizations for acute exacerbations of COPD (AECOPD) led to reduced hospital utilization during the following 24 months compared to the year prior to study start. Aims To analyze the impact of the COPD-Home IDM intervention on health related quality of life, symptoms of anxiety and depression, and the degree of patient activation during 24 months of follow-up and to assess the association between these outcomes. Methods A single center, prospective, open, controlled clinical study. Changes in The St. George Respiratory Questionnaire (SGRQ), the Hospital anxiety (HADS-A) and depression (HADS-D) and the patient activation measure (PAM) scores were compared between the patients in the integrated care group (ICG) and the usual care group (UCG) 6, 12 and 24 months after enrolment. Results The questionnaire response rate was 80–96%. There were no statistically significant differences in the change of the SGRQ scores between the groups during follow up. After 12 months of follow-up there was a trend towards a reduction in the mean HADS–A score in the ICG compared to the UCG. The HADS-D scores remained stable in the ICG compared with an increasing trend in the UCG. Clinically significant difference in the PAM score was achieved only in the ICG, 6.7 (CI95% 0.7 to 7.5) compared to 3.6 (CI95% -1.4 to 8.6) in the UCG. In a logistic regression model a higher HADS-D score and current smoking significantly increased the odds for a low PAM score. Conclusion The COPD–Home IDM intervention did not result in any statistically significant changes in mean SGRQ, HADS-A, HADS- D or PAM scores during the 24 months of follow-up. Trial registration The ID number for the study in the Clinical.Trials.gov registration system is 17417. ClinicalTrials.gov Identifier: NCT 00702078 PMID:28060921

  13. A new endocapsular open ring for prevention of anterior and posterior capsule opacification

    Science.gov (United States)

    Pallikaris, Ioannis G; Stojanovic, Nela R; Ginis, Harilaos S

    2016-01-01

    Purpose The aim of this study is to demonstrate the functionality of a new design of a thick endocapsular open ring for prevention of anterior capsule opacification (ACO) and posterior capsule opacification (PCO). Setting The Institute of Vision and Optics, University of Crete and University Hospital of Heraklion, Crete, Greece. Design Prospective, interventional pilot study. Methods Fifteen patients (17 eyes) underwent cataract surgery with phacoemulsification. During surgery, a thick endocapsular open ring (peripheral capsule reconstructor) was inserted into the capsular bag, prior to intraocular lens (IOL) implantation. Six different models of IOL were implanted. Postoperatively, the degree of ACO and PCO was evaluated and described as none, mild, moderate, or severe. Results The mean follow-up period was 30±8.06 months (range: 12–36 months). At the last follow-up, mild PCO was observed in only three eyes and mild ACO in three patients. The centration of IOLs was good in all but one eye, which had a tilted IOL. Conclusion The results of this pilot study suggest that the implantation of a new design of thick endocapsular open ring is feasible and may contribute to the prevention of PCO and ACO after cataract surgery. PMID:27843291

  14. A new endocapsular open ring for prevention of anterior and posterior capsule opacification

    Directory of Open Access Journals (Sweden)

    Pallikaris IG

    2016-11-01

    Full Text Available Ioannis G Pallikaris, Nela R Stojanovic, Harilaos S Ginis Institute of Vision and Optics, Department of Medicine, University of Crete, Heraklion, Crete, Greece Purpose: The aim of this study is to demonstrate the functionality of a new design of a thick endocapsular open ring for prevention of anterior capsule opacification (ACO and posterior capsule opacification (PCO. Setting: The Institute of Vision and Optics, University of Crete and University Hospital of Heraklion, Crete, Greece. Design: Prospective, interventional pilot study. Methods: Fifteen patients (17 eyes underwent cataract surgery with phacoemulsification. During surgery, a thick endocapsular open ring (peripheral capsule reconstructor was inserted into the capsular bag, prior to intraocular lens (IOL implantation. Six different models of IOL were implanted. Postoperatively, the degree of ACO and PCO was evaluated and described as none, mild, moderate, or severe. Results: The mean follow-up period was 30±8.06 months (range: 12–36 months. At the last follow-up, mild PCO was observed in only three eyes and mild ACO in three patients. The centration of IOLs was good in all but one eye, which had a tilted IOL. Conclusion: The results of this pilot study suggest that the implantation of a new design of thick endocapsular open ring is feasible and may contribute to the prevention of PCO and ACO after cataract surgery. Keywords: intraocular implant, cataract, phacoemulsification, silicone

  15. Prospective ergonomics: origin, goal, and prospects.

    Science.gov (United States)

    Robert, Jean-Marc; Brangier, Eric

    2012-01-01

    So far ergonomics has been concerned with two categories of activities: correction and design. We propose to add a third category: prospection, and by so doing, we introduce a new series of activities that opens up the future of ergonomics. Corrective ergonomics relates to the past and comes with a demand and a client. It is turned towards the correction of existing situations and aims to reduce or eliminate problems. Here, after delimiting and defining the problem, the challenge is to find the best solution. Ergonomics for design relates to the present and also comes with a demand and a client. It is turned towards the design of new artefacts that have already been identified by a client, and that will allow users to do some activity and attain their goals. Here, after defining the scope of the project and the functional requirements, the challenge is to do the best design. Finally, prospective ergonomics relates to the future and does not come with a demand and a client. It is turned towards the creation of future things that have not been identified yet. Here the challenge is to detect existing user needs or anticipate future ones, and imagine solutions. These three categories of activities overlap and are not exclusive of each other. In this paper we define prospective ergonomics and compare it with corrective ergonomics and ergonomics for design. We describe its origin, goal, and prospects, we analyze its impacts on education and practice, and we emphasize the need of new collaboration between ergonomics and other disciplines.

  16. Benefits of use, and tolerance of, medium-chain triglyceride medical food in the management of Japanese patients with Alzheimer’s disease: a prospective, open-label pilot study

    Directory of Open Access Journals (Sweden)

    Ohnuma T

    2016-01-01

    Full Text Available Tohru Ohnuma, Aiko Toda, Ayako Kimoto, Yuto Takebayashi, Ryoko Higashiyama, Yuko Tagata, Masanobu Ito, Tsuneyoshi Ota, Nobuto Shibata, Heii Arai Department of Psychiatry, Juntendo University Alzheimer’s Disease Project, Faculty of Medicine, Juntendo University, Tokyo, Japan Objectives: This is the first clinical trial of this type in Japan, designed to analyze two important aspects of Alzheimer’s disease (AD management using medium-chain triglycerides. Axona was administered for 3 months (40 g of powder containing 20 g of caprylic triglycerides. We used an indurating, four-step dose-titration method (from 10 to 40 g per day for 7 days before the trial, and examined the tolerance and adverse effects of this intervention. We also investigated its effect on cognitive function in mild-to-moderate AD patients.Patients and methods: This was a clinical intervention in 22 Japanese patients with sporadic AD at a mild-to-moderate stage (ten females, 12 males, mean age (± standard deviation 63.9 (±8.5 years, Mini-Mental State Examination (MMSE score, 10–25, seven patients were ApoE4-positive. During Axona administration, we examined changes in cognitive function by obtaining MMSE and AD assessment-scale scores. Intolerance and serum ketone concentrations were also examined.Results: The tolerance of Axona was good, without severe gastrointestinal adverse effects. Axona did not improve cognitive function in our sample of AD patients, even in those patients without the ApoE4 allele. However, some ApoE4-negative patients with baseline MMSE score ≥14 showed improvement in their cognitive functions.Conclusion: The modified dose-titration method, starting with a low dose of Axona, decreased gastrointestinal adverse effects in Japanese patients. Axona might be effective for some relatively mildly affected patients with AD (with cognitive function MMSE score of ≥14 and lacking the ApoE4 allele. Keywords: Alzheimer’s disease, medium-chain triglycerides, ketone, cognitive function, apolipoprotein E epsilon 4

  17. Open access

    NARCIS (Netherlands)

    Valkenburg, P.M.

    2015-01-01

    Open access week Van 19 tot en met 25 oktober 2015 vond wereldwijd de Open Access Week plaats. Tijdens deze week werden er over de hele wereld evenementen georganiseerd waar open access een rol speelt. Ook in Nederland zijn er diverse symposia, workshops en debatten georganiseerd zoals het debat in

  18. Prospective Science Teachers' Conceptions about Astronomical Subjects

    Science.gov (United States)

    Küçüközer, Hüseyin

    2007-01-01

    The main objective of this study was to identify prospective science teachers' conceptions on basic astronomical phenomena. A questionnaire consisting of nine open-ended questions was administered to 327 prospective science teachers. The questionnaire was constructed after extensive review of the literature and took into consideration the reported…

  19. Pilot Boarding Areas

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Pilot boarding areas are locations at sea where pilots familiar with local waters board incoming vessels to navigate their passage to a destination port. Pilotage is...

  20. Biodiversity Prospecting.

    Science.gov (United States)

    Sittenfeld, Ana; Lovejoy, Annie

    1994-01-01

    Examines the use of biodiversity prospecting as a method for tropical countries to value biodiversity and contribute to conservation upkeep costs. Discusses the first agreement between a public interest organization and pharmaceutical company for the extraction of plant and animal materials in Costa Rica. (LZ)

  1. 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…

  2. 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…

  3. Open hardware for open science

    CERN Multimedia

    CERN Bulletin

    2011-01-01

    Inspired by the open source software movement, the Open Hardware Repository was created to enable hardware developers to share the results of their R&D activities. The recently published CERN Open Hardware Licence offers the legal framework to support this knowledge and technology exchange.   Two years ago, a group of electronics designers led by Javier Serrano, a CERN engineer, working in experimental physics laboratories created the Open Hardware Repository (OHR). This project was initiated in order to facilitate the exchange of hardware designs across the community in line with the ideals of “open science”. The main objectives include avoiding duplication of effort by sharing results across different teams that might be working on the same need. “For hardware developers, the advantages of open hardware are numerous. For example, it is a great learning tool for technologies some developers would not otherwise master, and it avoids unnecessary work if someone ha...

  4. Subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder manual therapy plus exercise intervention in individuals with subacromial impingement syndrome: a prospective, randomized controlled clinical trial pilot study.

    Science.gov (United States)

    Wright, Alexis A; Donaldson, Megan; Wassinger, Craig A; Emerson-Kavchak, Alicia J

    2017-09-01

    To determine the subacute effects of cervicothoracic spinal thrust/non-thrust in addition to shoulder non-thrust plus exercise in patients with subacromial pathology. This was a randomized, single blinded controlled trial pilot study. This trial was registered at ClinicalTrials.gov (NCT01753271) and reported according to Consolidated Standards of Reporting Trials requirements. Patients were randomly assigned to either shoulder treatment plus cervicothoracic spinal thrust/non-thrust or shoulder treatment-only group. Primary outcomes were average pain intensity (Numeric Pain Rating Scale) and physical function (Shoulder Pain and Disability Index) at 2 weeks, 4 weeks, and patient discharge. 18 patients, mean age 43.1(15.8) years satisfied the eligibility criteria and were analyzed for follow-up data. Both groups showed statistically significant improvements in both pain and function at 2 weeks, 4 weeks, and discharge. The between-group differences for changes in pain or physical function were not significant at any time point. The addition of cervicothoracic spinal thrust/non-thrust to the shoulder treatment-only group did not significantly alter improvement in pain or function in patients with subacromial pathology. Both approaches appeared to provide an equally notable benefit. Both groups improved on all outcomes and met the criteria for clinical relevance for both pain and function. 2b.

  5. Open Access

    Science.gov (United States)

    Suber, Peter

    2012-01-01

    The Internet lets us share perfect copies of our work with a worldwide audience at virtually no cost. We take advantage of this revolutionary opportunity when we make our work "open access": digital, online, free of charge, and free of most copyright and licensing restrictions. Open access is made possible by the Internet and copyright-holder…

  6. Open Access

    Science.gov (United States)

    Suber, Peter

    2012-01-01

    The Internet lets us share perfect copies of our work with a worldwide audience at virtually no cost. We take advantage of this revolutionary opportunity when we make our work "open access": digital, online, free of charge, and free of most copyright and licensing restrictions. Open access is made possible by the Internet and copyright-holder…

  7. [Impact of a pre-operative mobilisation program using the Viv-Arte training model based on kinesthetic mobilisation on mobility, pain, and post-operation length of stay of patients receiving an elective medial laparotomy: a prospective, randomised, controlled pilot study].

    Science.gov (United States)

    Haasenritter, Jörg; Eisenschink, Anna Maria; Kirchner, Elisabeth; Bauder-Missbach, Heidi; Brach, Michael; Veith, Jessica; Sander, Silvia; Panfil, Eva-Maria

    2009-02-01

    A medial incision is a common surgical technique to obtain access to the abdomen. Thereby, the muscles involved in movement are manipulated, leading to post-operative restrictions in mobility and pain determined by movement. The aim of this pilot study was to assess the impact of a pre-operative training session using the Viv-Arte model, which is based on kinesthetic mobilisation principles. The parameters to be measured were mobility, pain, and length of hospital stay for patients, who were undergoing elective medial laparotomy. In addition, the study tested the research design and to identify possible effect sizes. The method chosen was a prospective, randomised, controlled, and unblinded design. Twenty-seven patients were involved (median=63 years, 19 of the patients were male) who were to have a medial incision for cystectomy. The intervention involved pre-operative training of post-operative mobility techniques. Mobility was tested using the "Mobilitätstest für Patienten im Akutkrankenhaus (MOTPA) (Mobility test for patients in hospital)"; pain intensity was assessed using the visual analogue scale. The intervention and control groups were comparable for all variables. There were no significant differences in the two groups related to the objectives. It is possible that the study groups or the operationalisation were not appropriate for testing the effects of the intervention. It seems important to continue to develop instruments that are appropriate for measuring the effect of mobility-related interventions.

  8. A prospective clinical, economic, and quality-of-life analysis comparing endovascular aneurysm repair (EVAR), open repair, and best medical treatment in high-risk patients with abdominal aortic aneurysms suitable for EVAR: the Irish patient trial.

    LENUS (Irish Health Repository)

    Hynes, Niamh

    2007-12-01

    To report the results of a trial comparing endovascular aneurysm repair (EVAR) to open repair (OR) and best medical therapy (BMT) involving high-risk patients with abdominal aortic aneurysms (AAA) suitable for EVAR.

  9. Open Source and Open Standards

    NARCIS (Netherlands)

    Koper, Rob

    2006-01-01

    Publication reference: Koper, R. (2008). Open Source and Open Standards. In J. M. Spector, M. Merrill, J. van Merriënboer & M. P. Driscol (Eds.), Handbook of Research on Educational Communications and Technology (3rd ed., pp. 355-368). New York: Routledge.

  10. Assessment of the capability of a gelling complex made of tara gum and the exopolysaccharides produced by the microorganism Streptococcus thermophilus ST10 to prospectively restore the gut physiological barrier: a pilot study.

    Science.gov (United States)

    Del Piano, Mario; Balzarini, Marco; Carmagnola, Stefania; Pagliarulo, Michela; Tari, Roberto; Nicola, Stefania; Deidda, Francesca; Pane, Marco

    2014-01-01

    Leaky gut, or intestinal permeability, is the phenomenon of the gut wall exhibiting increased absorbency. It is pretty well recognised that an altered or damaged bowel lining or gut wall may result from unbalanced diet, parasites, infection, or medications and that this allows substances such as toxins, microbes, undigested food, or waste to leak through. As a natural consequence, this prompts the body to initiate an immune reaction leading to potentially severe health conditions. Different strategies may be used to improve, at least temporarily, the physiological intestinal barrier. The use of specific beneficial microorganisms, such as lactobacilli and bifidobacteria, has been suggested as an innovative tool to counteract an improper level of intestinal permeability. The association of bacteria with specific gelling agents, such as gums, may represent an improvement since these molecules are able to form hydrophilic gels that distribute uniformly over the inner intestinal surface. This pilot study was undertaken to evaluate intestinal permeability in subjects treated with a gelling complex, an association of tara gum and the microorganism Streptococcus thermophilus ST10 (DSM 25246), which has a well-demonstrated in vitro ability to synthesise and secrete exopolysaccharides (EPSs). Twenty-five healthy subjects were enrolled in this human intervention, double-blind, placebo-controlled, pilot trial (age between 21 and 57 y, mean 37.7±11.2). Subjects were then randomised into 2 groups: group A (13 subjects) was given an active formulation containing 250 mg of tara gum and 1 billion viable cells of S. thermophilus ST10, whereas group B (12 subjects) was given a placebo formulation. All the subjects participating in the study were directed to take 1 dose per day for 30 consecutive days. The presence and concentration of exopolysaccharides (EPSs) in the faeces was determined at time 0 (d0), after 30 days of treatment (d30), and at the end of the 2-week follow-up period

  11. A six-month, multicenter, open-label, noncomparative, prospective, observational study of the efficacy and tolerability of atorvastatin in the primary care setting(estudio del control de las hiperlipidemiasen atención primaria): the cheap study.

    Science.gov (United States)

    Gómez-Gerique, Juan A; Alvarez-Sala, Luis A; Armada, Beatriz; Fernández-Arias, Isabel; Martinez, Javier; Hernández, Gonzalo

    2003-06-01

    A close relationship exists between high levels of total cholesterol (TC) (particularly low-density lipoprotein cholesterol [LDL-C]) and low levels of high-density lipoprotein cholesterol (HDL-C), which is associated with an increased risk for arteriosclerosis and cardiovascular disease (CVD). Evidence shows that atorvastatin produces significantly greater reductions in LDL-C and TC than other hydroxymethylglutaryl-coenzyme A reductase inhibitors. However, the results achieved in clinical studies could be different from those found in general clinical practice, where patient follow-up is less thorough and poorer compliance may reduce the effectiveness of the lipid-lowering therapy. The aim of this study was to assess the effectiveness of atorvastatin in achieving the LDL-C levels recommended by several Spanish scientific societies, as well as its tolerability in standard clinical use. This 6-month, open-label, noncomparative, prospective, observational study was conducted in 1351 primary care centers in Spain. All patients were aged 18 to 80 years and had primary hypercholesterolemia (TC >200 mg/dL and triglycerides [TG] 200 mg/dL and fasting TG 200-400 mg/dL). All patients also had LDL-C levels higher than those established by the Spanish Society of Arteriosclerosis (Sociedad Española de Arteriosclerosis [SEA]) according to baseline cardiovascular risk and previous use of lipid-lowering therapy (for patients with low, moderate, or high cardiovascular risk, the recommended LDL-C goals are ≤175 mg/dL, ≤155 mg/dL, and ≤135 mg/dL, respectively; for patients with CVD, the LDL-C goal is ≤100 mg/dL). None of the patients had creatine kinase activity ≥540 U/L or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥60 U/L. Study visits occurred at months 0, 2, and 6 of treatment. Patients received atorvastatin calcium 10 mg/d for 2 months. The dosage was then doubled to 20 mg/d in patients who did not achieve the SEA LDL-C goal and also

  12. Utility of T-Cell Interferon-γ Release Assays for Etiological Diagnosis of Classic Fever of Unknown Origin in a High Tuberculosis Endemic Area--a pilot prospective cohort.

    Science.gov (United States)

    Shi, Xiaochun; Zhang, Lifan; Zhang, Yueqiu; Zhou, Baotong; Liu, Xiaoqing

    2016-01-01

    Tuberculosis (TB), especially extrapulmonary TB is still the leading cause of fever of unknown origin (FUO) in China. However, diagnosis of TB still remains a challenge. The aim of this study was to evaluate the diagnostic value of T-SPOT.TB for etiological diagnosis of classic FUO in adult patients in a high TB endemic area. We prospectively enrolled patients presenting with classic FUO in a tertiary referral hospital in Beijing, China, to investigate the diagnostic sensitivity, specificity, predictive values and likelihood ratio of T-SPOT.TB. Clinical assessment and T-SPOT.TB were performed. Test results were compared with the final confirmed clinical diagnosis. 387 hospitalized patients (male n = 194, female n = 193; median age 46 (range 29-59) yrs) with classic FUO were prospectively enrolled into this study. These FUOs were caused by infection (n = 158, 40.8%), connective tissue disease (n = 82, 21.2%), malignancy (n = 41, 10.6%) and miscellaneous other causes (n = 31, 8.0%), and no cause was determined in 75 (19.4%) patients. 68 cases were diagnosed as active TB eventually. The sensitivity of T-SPOT.TB for the diagnosis of active TB was 70.6% (95%CI 58.9-80.1%), while specificity was 84.4% (95%CI 79.4-88.4%), positive predictive value was 55.8% (95%CI 45.3-65.8%), negative predictive value was 91.2% (95%CI 86.7-94.2%). Among these 68 active TB patients, 12 cases were culture or histology confirmed (11 cases with positive T-SPOT.TB, sensitivity was 91.7%) and 56 cases were clinically diagnosed (37 cases with positive T-SPOT.TB, sensitivity was 66.1%); 14 cases were pulmonary TB (13 cases with positive T-SPOT.TB, sensitivity was 92.9%) and 54 cases were extrapulmonary TB (35 cases with positive T-SPOT.TB, sensitivity was 64.8%). For patients presenting with classic FUO in this TB endemic setting, T-SPOT.TB appears valuable for excluding active TB, with a high negative predictive value.

  13. Utility of T-Cell Interferon-γ Release Assays for Etiological Diagnosis of Classic Fever of Unknown Origin in a High Tuberculosis Endemic Area--a pilot prospective cohort.

    Directory of Open Access Journals (Sweden)

    Xiaochun Shi

    Full Text Available Tuberculosis (TB, especially extrapulmonary TB is still the leading cause of fever of unknown origin (FUO in China. However, diagnosis of TB still remains a challenge. The aim of this study was to evaluate the diagnostic value of T-SPOT.TB for etiological diagnosis of classic FUO in adult patients in a high TB endemic area.We prospectively enrolled patients presenting with classic FUO in a tertiary referral hospital in Beijing, China, to investigate the diagnostic sensitivity, specificity, predictive values and likelihood ratio of T-SPOT.TB. Clinical assessment and T-SPOT.TB were performed. Test results were compared with the final confirmed clinical diagnosis.387 hospitalized patients (male n = 194, female n = 193; median age 46 (range 29-59 yrs with classic FUO were prospectively enrolled into this study. These FUOs were caused by infection (n = 158, 40.8%, connective tissue disease (n = 82, 21.2%, malignancy (n = 41, 10.6% and miscellaneous other causes (n = 31, 8.0%, and no cause was determined in 75 (19.4% patients. 68 cases were diagnosed as active TB eventually. The sensitivity of T-SPOT.TB for the diagnosis of active TB was 70.6% (95%CI 58.9-80.1%, while specificity was 84.4% (95%CI 79.4-88.4%, positive predictive value was 55.8% (95%CI 45.3-65.8%, negative predictive value was 91.2% (95%CI 86.7-94.2%. Among these 68 active TB patients, 12 cases were culture or histology confirmed (11 cases with positive T-SPOT.TB, sensitivity was 91.7% and 56 cases were clinically diagnosed (37 cases with positive T-SPOT.TB, sensitivity was 66.1%; 14 cases were pulmonary TB (13 cases with positive T-SPOT.TB, sensitivity was 92.9% and 54 cases were extrapulmonary TB (35 cases with positive T-SPOT.TB, sensitivity was 64.8%.For patients presenting with classic FUO in this TB endemic setting, T-SPOT.TB appears valuable for excluding active TB, with a high negative predictive value.

  14. Open Clusters and OB Associations: a Review

    Directory of Open Access Journals (Sweden)

    Anthony G. A. Brown

    2001-01-01

    Full Text Available In this review on open clusters and OB associations I discuss some recent developments to which Latin American astronomers have contributed. Subsequently, results from the Hipparcos mission concerning OB associations, the Hyades and other nearby open clusters will be discussed. I end with a brief discussion of current theories of star cluster formation and prospects for future research.

  15. A pilot eduroam service at CERN

    CERN Multimedia

    2014-01-01

    Eduroam is a secure, worldwide roaming Wi-Fi access service developed for the international research and education community. It allows people from participating institutions to obtain an Internet connection when visiting other participating institutions by simply opening their laptop.   A pilot eduroam service has been available in IT for some months. Now this pilot service will be extended to most parts of the CERN site from early January. Introduction of this pilot service brings two advantages: CERN users who register with the eduroam service here at CERN will have easy and quick access to Wi-Fi services at many other academic institutions across Europe and beyond;   People visiting CERN from other eduroam institutes will be able to connect to the Wi-Fi network at CERN without waiting for a network connection request to be approved. Being a eduroam user obviously has advantages but, like many computing services, eduroam provides a way for malicious people to steal passwords...

  16. The ENIQ pilot study: current status

    Energy Technology Data Exchange (ETDEWEB)

    Lemaitre, P.; Eriksen, B.; Crutzen, S. [European Commission, DG Joint Research Centre, Petten (Netherlands); Hansch, M. [Preussische Elektrizitaets-AG (Preussenelektra), Hannover (Germany); Whittle, J. [AEA Technology, Warrington (United Kingdom)

    1998-11-01

    A pilot study is currently being carried out by ENIQ (European Network for Inspection Qualification) in order to explore the issues involved in inspection qualification applied along the general principles of the European methodology. The components selected for the pilot study are austenitic pipe to pipe and pipe to elbows welds typical of those in BWR recirculation loops. A range of defect parameters has been defined. A suitable inspection procedure designed to find the designated defects will be applied to geometrically representative test pieces. The procedure/equipment will be qualified through open trials and technical justification. The personnel qualification will be done in a blind way. Once all features of the inspection system will have been qualified an in-service inspection will be simulated in order to test the feasibility of the qualification approach followed. In this paper the current status of this pilot study is discussed. (orig.)

  17. A pilot eduroam service at CERN

    CERN Multimedia

    2013-01-01

    Eduroam is a secure, worldwide roaming Wi-Fi access service developed for the international research and education community. It allows people from participating institutions to obtain an Internet connection when visiting other participating institutions by simply opening their laptop.   A pilot eduroam service has been available in IT for some months. Now this pilot service will be extended to most parts of the CERN site from early January. Introduction of this pilot service brings two advantages: CERN users who register with the eduroam service here at CERN will have easy and quick access to Wi-Fi services at many other academic institutions across Europe and beyond;   People visiting CERN from other eduroam institutes will be able to connect to the Wi-Fi network at CERN without waiting for a network connection request to be approved. Being a eduroam user obviously has advantages but, like many computing services, eduroam provides a way for malicious people to steal passwords...

  18. Open IS

    DEFF Research Database (Denmark)

    Germonprez, Matt; Crowston, Kevin; Avital, Michel

    2013-01-01

    The collective intelligence and collective action of “open” communities have produced a variety of complex knowledge goods and radical social change. The Information Systems (IS) community has invested significant effort into researching open communities and the ecosystems in which they operate...... therefore seeks to stimulate a thoughtful and dynamic discussion around the proposition that becoming a more open community will enhance the IS discipline’s scholarly inquiry and global impact....

  19. Open IS

    DEFF Research Database (Denmark)

    Germonprez, Matt; Crowston, Kevin; Avital, Michel

    2013-01-01

    The collective intelligence and collective action of “open” communities have produced a variety of complex knowledge goods and radical social change. The Information Systems (IS) community has invested significant effort into researching open communities and the ecosystems in which they operate...... therefore seeks to stimulate a thoughtful and dynamic discussion around the proposition that becoming a more open community will enhance the IS discipline’s scholarly inquiry and global impact....

  20. Juicy Prospects

    Institute of Scientific and Technical Information of China (English)

    Ali Ali

    2011-01-01

    THE city of Yantai in east China's Shandong Province has long been famed in history for its extensive coastline,its breathtaking scenery and its abundance of fruit.Being one of the first ports to open up to Europeans during the 19th century,the city is no stranger to progression,especially in terms of economics.

  1. Effects on heart function of neoadjuvant chemotherapy and chemoradiotherapy in patients with cancer in the esophagus or gastroesophageal junction - a prospective cohort pilot study within a randomized clinical trial.

    Science.gov (United States)

    Lund, Mikael; Alexandersson von Döbeln, Gabriella; Nilsson, Magnus; Winter, Reidar; Lundell, Lars; Tsai, Jon A; Kalman, Sigridur

    2015-01-13

    Neoadjuvant therapy for cancer of the esophagus or gastroesophageal (GE)-junction is well established. The pros and cons of chemoradiotherapy and chemotherapy are debated. Chemoradiotherapy might impair cardiac function eliciting postoperative morbidity. The aim of this pilot study was to describe acute changes in left ventricular function following chemoradiotherapy or chemotherapy. Patients with esophageal and (GE)-junction cancer enrolled at our center into a multicenter trial comparing neoadjuvant chemoradiotherapy and chemotherapy were eligible. Patients were randomized to receive cisplatin and 5-fluorouracil with or without the addition of 40 Gy radiotherapy prior to surgery. Left ventricular function was evaluated using echocardiography and plasma N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) before and after neoadjuvant treatment. The primary outcome measure was left ventricular global strain (GS). Clinical effects were assessed using repeated exercise tests. Linear mixed models were used to analyze the effects of treatment group, and the interaction between groups. 40 patients participated (chemoradiotherapy, n=17; chemotherapy, n=23). In the chemoradiotherapy group there was no change in left ventricular global strain but mitral annular plane systolic excursion (MAPSE) of the ventricular septum, early diastolic filling velocity (E-velocity), and the ratio of early to late ventricular filling velocities (E/A ratio) decreased significantly (p=0.02, p=0.01, and p=0.03, respectively). No changes were observed in the chemotherapy group. There was a trend towards an interaction effect for MAPSE sept and E (p=0.09 and p=0.09). NT-proBNP increased following chemoradiotherapy (p=0.05) but not after chemotherapy (p>0.99), and there was a trend towards an interaction effect (p=0.07). Working capacity decreased following neoadjuvant treatment (chemoradiotherapy p = 0.001, chemotherapy p=0.03) and was more pronounced after chemoradiotherapy with a trend

  2. Uncontrolled, open-label, pilot study of tea tree (Melaleuca alternifolia) oil solution in the decolonisation of methicillin-resistant Staphylococcus aureus positive wounds and its influence on wound healing.

    Science.gov (United States)

    Edmondson, Margaret; Newall, Nelly; Carville, Keryln; Smith, Joanna; Riley, Thomas V; Carson, Christine F

    2011-08-01

    Many complementary and alternative products are used to treat wounds. The essential oil of Melaleuca alternifolia, tea tree oil, has proven antimicrobial and anti-inflammatory properties, may be useful in methicillin-resistant Staphylococcus aureus (MRSA) decolonisation regimens and is reputed to have 'wound-healing' properties, but more data are required to support these indications. The primary aim of this uncontrolled case series was to assess whether a tea tree oil solution used in a wound cleansing procedure could decolonise MRSA from acute and chronic wounds of mixed aetiology. The secondary aim was to determine if the tea tree oil solution influenced wound healing outcomes. Nineteen participants with wounds suspected of being colonised with MRSA were enrolled in a pilot study. Seven were subsequently shown not to have MRSA and were withdrawn from the study. As many as 11 of the remaining 12 participants were treated with a water-miscible tea tree oil (3·3%) solution applied as part of the wound cleansing regimen at each dressing change. Dressing changes were three times per week or daily as deemed necessary by the study nurse following assessment. One participant withdrew from the study before treatment. No participants were MRSA negative after treatment. After treatment had been implemented, 8 of the 11 treated wounds had begun to heal and reduced in size as measured by computer planimetry. Although this formulation and mode of delivery did not achieve the primary aim of the study, tea tree oil did not appear to inhibit healing and the majority of wounds reduced in size after treatment.

  3. Wastewater treatment pilot

    OpenAIRE

    2016-01-01

    The aim of this thesis was to investigate the functionality of the wastewater treatment pilot and produce a learning manual-handout, as well as to define the parameters of wastewater clarification by studying the nutrient removal and the effluent clarification level of the processed wastewater. As part of the Environmental Engineering studies, Tampere University of Applied Sciences has invested on a Wastewater Treatment Pilot. The pilot simulates the basic wastewater treatment practices u...

  4. Explosive Formulation Pilot Plant

    Data.gov (United States)

    Federal Laboratory Consortium — The Pilot Plant for Explosive Formulation supports the development of new explosives that are comprised of several components. This system is particularly beneficial...

  5. Open access

    CERN Document Server

    Suber, Peter

    2012-01-01

    The Internet lets us share perfect copies of our work with a worldwide audience at virtually no cost. We take advantage of this revolutionary opportunity when we make our work "open access": digital, online, free of charge, and free of most copyright and licensing restrictions. Open access is made possible by the Internet and copyright-holder consent, and many authors, musicians, filmmakers, and other creators who depend on royalties are understandably unwilling to give their consent. But for 350 years, scholars have written peer-reviewed journal articles for impact, not for money, and are free to consent to open access without losing revenue. In this concise introduction, Peter Suber tells us what open access is and isn't, how it benefits authors and readers of research, how we pay for it, how it avoids copyright problems, how it has moved from the periphery to the mainstream, and what its future may hold. Distilling a decade of Suber's influential writing and thinking about open access, this is the indispe...

  6. Oral Pirfenidone in patients with chronic fibrosis resulting from radiotherapy: a pilot study

    Directory of Open Access Journals (Sweden)

    Mitchell James B

    2007-05-01

    Full Text Available Abstract Background Fibrosis is a common side effect after treatment with ionizing radiation. Several methods to ameliorate debilitating fibrosis have been employed but without consistent results. The goal of this pilot study is to determine if Pirfenidone, a novel regulator of cytokine gene expression, has the potential to ameliorate established radiation-induced fibrosis. Methods Open label, prospective pilot study of 800 mg three times/day, orally administered Pirfenidone was administered to enrolled patients who were had completed radiation therapy and who had established radiation-induced fibrosis. Range of motion (ROM was assessed using standard measures, and subjective measures of pain, fatigue, disability and global health were measured every three months. Results Seven patients were enrolled of whom 3 had ROM assessments of 1 site and 2 had ROM assessments of 2 sites. Of these assessments, 6 revealed increased ROM during drug intervention while 1 revealed a decreased ROM. There was an overall improvement in the mental composite score of the SF36 while physical composite score was decreased and the vitality score was unchanged. Two patients were removed from the study because of syncopal episodes. Conclusion Several patients experienced improved function of at least 25% and reported subjective improvement. Pirfenidone may benefit patients with radiation-induced fibrosis and is worthy of a larger well controlled trial.

  7. PROSPECTIVE TEACHERS' EXPECTATIONS FROM TEACHING PROFESSION (CASE OF FIRAT UNIVERSITY)

    OpenAIRE

    Mehmet Nuri GÖMLEKSİZ; KAN, AYSE ÜLKÜ; Biçer, Serav

    2010-01-01

    ABSTRACT The aim of this descriptive study is to determine prospective teachers' expectation level for teaching profession. For that aim, fourth year students of Education Faculty and non-thesis master's program were included in the study. Five-point Likert-style scale used in the study was developed by the researchers. The items were classified into four categories named socio-cultural, professional, financial and career expectations. The scale was piloted on 119 prospective teach...

  8. The use aeroplanes and vehicles for prospecting. The technique of the detection radioactivity. The future opened up by the use of the discrimination of energies; Methodes de prospection autoportee et aeroportee. La technique de la detection des rayonnements. Les perspectives offertes par la discrimination des energies

    Energy Technology Data Exchange (ETDEWEB)

    Guitton, J.; Berbezier, J.; Blangy, B.; Lallemant, C. [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1958-07-01

    The idea of installing activity detectors on aeroplanes and vehicles has been widely applied by the CEA since the start of prospecting in the arid and tropical regions of the Communaute Francaise. Three systems of detection have been developed and compared in a systematic manner: a group of 50 G.M. tubes; the sodium iodide scintillator; the plastic scintillator. The sodium iodide scintillator is used as a standard reference; the results are compared by graphical recording. Airborne prospecting is carried out in two stages: the initial flights, which follow a kilometre square network, make possible the discovery of the most likely zones; these likely zones are then examined in greater detail using light aeroplanes or helicopters. The two types of airborne scintillation measuring devices which have been developed by the CEA are described in this article. The practical results obtained during systematic and detailed airborne prospecting campaigns in the Hoggar are described. The difficulty in airborne uranium prospecting is to be able to immediately distinguish while in flight, anomalies caused by uranium from those caused by thorium. (author) [French] L'idee de monter des detecteurs de rayonnements sur des avions ou des vehicules a ete largement appliquee par le CEA des le debut des prospections dans les pays sahariens et tropicaux de la Communaute Fran ise. On a realise et compare d'une maniere systematique trois moyens de detection: groupe de 50 tubes GM; scintillateur d'iodure de sodium, scintillateur plastique. L'appareil de reference sera le scintillateur d'iodure de sodium; les resultats sont compares par enregistrement graphique. La prospection aeroportee se fait en deux etapes; les premiers vols systematiques suivant un quadrillage kilometrique permettent de reperer les zones interessantes; ces dernieres font l'objet d'examens plus detailles effectues en avion leger ou en helicoptere. Dans cet article, on decrit les deux

  9. Open Brief

    Directory of Open Access Journals (Sweden)

    Andrew Leach

    2013-11-01

    Full Text Available To commence the thirtieth annual conference of the Society of Architectural Historians, Australia and New Zealand (SAHANZ, held on Australia’s Gold Coast in July 2013, ten delegates were invited with very little warning to take five minutes and one image to offer a provocation on the open matters of architectural history in the present moment. The term “open” was taken as the conference theme—a device used by SAHANZ meetings not so much to define the scope of papers presented as to declare the conference flavour year by year. It was not, therefore, an open conference (anything goes so much as a conference on open issues (where, indeed, to go.  The ten interlocutors were invited after the conference to document their interventions and they are presented here as a record of the preoccupations of a specific moment and institutional geography with all the idiosyncrasies and commonalities it might reveal to a broader audience.

  10. Risk propensity in commercial and military pilots.

    Science.gov (United States)

    Sicard, Bruno; Taillemite, Jean Pierre; Jouve, Elisabeth; Blin, Olivier

    2003-08-01

    Flight safety is dependent on the quality of the decision-making process, which is closely related to risk taking. The purpose of this descriptive study was to evaluate risk propensity among commercial and military pilots. Since commercial and military flights are conducted in different environments with different safety policies, our hypothesis was that risk propensity levels observed in these different settings will not be the same. We tested 96 French pilots, 63 who were flying commercial aircraft (mean age 43 yr) and 33 serving in military aviation (mean age 33 yr), with the Evaluation of Risk (EVAR) visual analog scale, designed to rate risk proneness, and the Barrat impulsiveness scale. EVAR is composed of 24 items distributed among 5 factors: "self-control," "danger-seeking," "energy," "impulsiveness," and "invincibility." We observed significantly higher scores in all EVAR factors except "impulsiveness" in military pilots compared with commercial pilots. This different risk profile was corroborated by Barrat scores and was not explained by the significant age difference. The observed difference in risk propensity cannot be explained by this descriptive study. A prospective evaluation of risk proneness beginning with the selection process and continuing through training and military and commercial flying is necessary to assess how a risk proneness profile is determined.

  11. Open Education and the Open Science Economy

    Science.gov (United States)

    Peters, Michael A.

    2009-01-01

    Openness as a complex code word for a variety of digital trends and movements has emerged as an alternative mode of "social production" based on the growing and overlapping complexities of open source, open access, open archiving, open publishing, and open science. This paper argues that the openness movement with its reinforcing structure of…

  12. The Open

    Directory of Open Access Journals (Sweden)

    Saitya Brata Das

    2009-12-01

    Full Text Available In the Open darkness and light, remembrance and oblivion, coming into existence and disappearing in death play their originary co-belonging, or co-figuration. Existence belongs to this opening and is exposed to its coming to presence: it is on the basis of this originary opening, this originary historical which is revealed to this mortal being called ‘man,’ on the basis of this revelation, man founds something like politics and history. There thus comes into existence out of this freedom, out of this “play space”2, this field called ‘polis’3 where there takes place war and festival, where historical revolutions tear apart history, brings ruptures and discontinuities in the very mode of his existence, where man seeks the foundation of his own foundation (which is his metaphysical task , where occurs the dialectics of negativity between man and man, where man puts at stake his own death, his own dissolution, and by the power of his own dissolution stands in relation to the total world that he seeks to dominate. This means that man’s attempts to metaphysically found his own political and historical existence must presuppose a far more originary non-foundation, the differentiating revealing of the open, the ungrounded spacing play, or playing space of natality and mortality.

  13. Open innovation

    DEFF Research Database (Denmark)

    West, Joel; Bogers, Marcel

    2017-01-01

    by small, new, and not-for-profit organizations, as well as the linkage of individual actions and motivations to open innovation. Other opportunities include better measuring the costs, benefits, antecedents, mediators and moderators of the effects of OI on performance, and understanding why and how OI...

  14. Transconjunctival retinopexy with active external drainage of subretinal fluid: a prospective pilot study of eight consecutive cases Retinopexia transconjuntival com drenagem externa do fluido sub-retiniano: um estudo piloto prospectivo de oito casos consecutivos

    Directory of Open Access Journals (Sweden)

    Rubens Camargo Siqueira

    2007-08-01

    Full Text Available PURPOSE: To describe an alternative surgical technique for the management of retinal detachment with no or minimal proliferative vitreoretinopathy (grade B using transconjunctival retinopexy with active external drainage of subretinal fluid. METHODS: In a prospective, interventional study, eight consecutive patients with retinal detachment with no or minimal proliferative vitreoretinopathy (grade B underwent transconjunctival retinopexy with active external drainage of subretinal fluid. Transconjunctival external drainage of subretinal fluid was achieved by using a 29 gauge needle placed in the subretinal space under indirect ophthalmoscopic monitoring. Active suction was performed (500 mmHg vacuum using a vitrectomy line coupled to the needle. After retinal reattachment, cryotherapy was applied to the scleral region corresponding to the area of the retinal break(s. RESULTS: In all cases there was retinal attachment at the end of surgery. Retinal redetachment occurred in four pseudophakic patients who then underwent pars plana vitrectomy. The four phakic patients maintained retinal attachment during follow-up (13-20 months. CONCLUSION: Transconjunctival retinopexy with active external drainage of subretinal fluid represents a useful, faster, and cheaper alternative to scleral buckling for retinal detachments with no or minimal proliferative retinopathy in phakic patients and, unlike scleral buckling, is not associated with induced myopia.OBJETIVO: Descrever uma técnica cirúrgica alternativa para o tratamento de descolamento da retina sem ou com mínima vitreorretinopatia proliferativa (grau B usando uma retinopexia transconjuntival com drenagem externa do fluido sub-retiniano. MÉTODOS: Prospectivo estudo intervencional, com oito pacientes consecutivos com descolamento da retina com nenhum ou mínima vitreorretinopatia proliferativa (grau B que foram submetidos a retinopexia transconjuntival com drenagem externa ativa do fluido sub

  15. Open source posturography.

    Science.gov (United States)

    Rey-Martinez, Jorge; Pérez-Fernández, Nicolás

    2016-12-01

    The proposed validation goal of 0.9 in intra-class correlation coefficient was reached with the results of this study. With the obtained results we consider that the developed software (RombergLab) is a validated balance assessment software. The reliability of this software is dependent of the used force platform technical specifications. Develop and validate a posturography software and share its source code in open source terms. Prospective non-randomized validation study: 20 consecutive adults underwent two balance assessment tests, six condition posturography was performed using a clinical approved software and force platform and the same conditions were measured using the new developed open source software using a low cost force platform. Intra-class correlation index of the sway area obtained from the center of pressure variations in both devices for the six conditions was the main variable used for validation. Excellent concordance between RombergLab and clinical approved force platform was obtained (intra-class correlation coefficient =0.94). A Bland and Altman graphic concordance plot was also obtained. The source code used to develop RombergLab was published in open source terms.

  16. Open Textbooks and Increased Student Access and Outcomes

    Science.gov (United States)

    Feldstein, Andrew; Martin, Mirta; Hudson, Amy; Warren, Kiara; Hilton, John, III; Wiley, David

    2012-01-01

    This study reports findings from a year-long pilot study during which 991 students in 9 core courses in the Virginia State University School of Business replaced traditional textbooks with openly licensed books and other digital content. The university made a deliberate decision to use open textbooks that were copyrighted under the Creative…

  17. Digital Badging at The Open University: Recognition for Informal Learning

    Science.gov (United States)

    Law, Patrina

    2015-01-01

    Awarding badges to recognise achievement is not a new development. Digital badging now offers new ways to recognise learning and motivate learners, providing evidence of skills and achievements in a variety of formal and informal settings. Badged open courses (BOCs) were piloted in various forms by the Open University (OU) in 2013 to provide a…

  18. Stapedotomy in osteogenesis imperfecta : a prospective study of 32 consecutive cases

    NARCIS (Netherlands)

    Vincent, Robert; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

    2014-01-01

    OBJECTIVE: To prospectively evaluate hearing outcomes in patients with osteogenesis imperfecta undergoing primary stapes surgery and to isolate prognostic factors for success. STUDY DESIGN: A nonrandomized, open, prospective case series. SETTING: A tertiary referral center. PATIENTS: Twenty-five con

  19. Stapedotomy in osteogenesis imperfecta : a prospective study of 32 consecutive cases

    NARCIS (Netherlands)

    Vincent, Robert; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

    2014-01-01

    OBJECTIVE: To prospectively evaluate hearing outcomes in patients with osteogenesis imperfecta undergoing primary stapes surgery and to isolate prognostic factors for success. STUDY DESIGN: A nonrandomized, open, prospective case series. SETTING: A tertiary referral center. PATIENTS: Twenty-five con

  20. Stapedotomy in osteogenesis imperfecta : a prospective study of 32 consecutive cases

    NARCIS (Netherlands)

    Vincent, Robert; Wegner, Inge; Stegeman, Inge; Grolman, Wilko

    2014-01-01

    OBJECTIVE: To prospectively evaluate hearing outcomes in patients with osteogenesis imperfecta undergoing primary stapes surgery and to isolate prognostic factors for success. STUDY DESIGN: A nonrandomized, open, prospective case series. SETTING: A tertiary referral center. PATIENTS: Twenty-five

  1. Open Source, Open Access, Open Review, Open Data. Initiativen zu mehr Offenheit in der digitalen Welt

    OpenAIRE

    Herb, Ulrich

    2011-01-01

    The article discusses the principles of openess, open access and open availability of information based on the examples of open access to scientific information, open government data, open geographical data and open source software.

  2. Open Source, Open Access, Open Review, Open Data. Initiativen zu mehr Offenheit in der digitalen Welt

    OpenAIRE

    Herb, Ulrich

    2011-01-01

    The article discusses the principles of openess, open access and open availability of information based on the examples of open access to scientific information, open government data, open geographical data and open source software.

  3. Combining knowledge mapping and videoconferencing for open sensemaking communities

    OpenAIRE

    Okada, Alexandra; Tomadaki, Eleftheria; Buckingham Shum, Simon; Scott, Peter

    2007-01-01

    The Open Educational Resources (OER) movement has been growing rapidly, opening up new opportunities for widening participation (Willinsky, 2006). OpenLearn is an OER pilot project developed by the UK Open University (OU) [http://www.open.ac.uk/openlearn], and launched in October 2006, supported by the William and Flora Hewlett Foundation. OpenLearn has published 3371 hours in the LearningSPace and 5194 in the LabSpace of OERs designed specifically for distance learning (the OU’s core busines...

  4. OpenAPC. Open-Access-Publikationskosten als Open Data

    OpenAIRE

    Tullney, Marco

    2015-01-01

    Präsentationsfolien zum Vortrag „OpenAPC. Open-Access-Publikationskosten als Open Data“ in der Session „Ausgestaltung eines wissenschaftsadäquaten APC-Marktes: Grundsätze, Finanzierungsansätze und Management“ der Open-Access-Tage 2015 in Zürich (https://www.open-access.net/community/open-access-tage/open-access-tage-2015-zuerich/programm/#c1974)

  5. 14 CFR 61.94 - Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations...

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Student pilot seeking a sport pilot... Student pilot seeking a sport pilot certificate or a recreational pilot certificate: Operations at... operational control tower in other airspace. (a) A student pilot seeking a sport pilot certificate or...

  6. 国外开放式创新理论研究11年:回顾、评述与展望%The 11 Years of Research on Open Innovation Theory in Foreign Countries:Review, Comment and Prospect

    Institute of Scientific and Technical Information of China (English)

    张永成; 郝冬冬; 王希

    2015-01-01

    The article reviews research results on open innovation during the past 11 years, constructs a integrated open innovation model, illuminates that its essence is that the innovation resources can realize more free flow, op-timized allocation and effective use among organizations, thus the innovation effectiveness is improved, believes that innovation performance is interactively affected by various factors inside and outside the organization, there-fore, dynamic and systematic methods can more effectively cope with many challenges that the open innovation faces than a single and static strategy does. At last, the article indicates that organizational network capacity and its building, innovative interface and its management, and co-creation and its result's share will become the future research emphasis.%对过去11年来国外开放式创新研究成果进行回顾,构建了一个整合性开放式创新模型,阐明了开放式创新实质是创新资源能够在组织之间自由流动、优化配置和有效利用,进而提高创新有效性的过程。认为其创新绩效受到组织内外各种因素的交互影响,而动态的、系统的管理策略往往比单一的、静态的策略更能有效应对开放式创新所面临的诸多挑战。指出组织网络能力及其建构、创新界面及其管理、共同创造及其成果分享会成为未来研究重点。

  7. Postoperative C-reactive protein concentration and clinical outcome: comparison of open cystectomy to robot-assisted laparoscopic cystectomy with extracorporeal or intracorporeal urinary diversion in a prospective study.

    Science.gov (United States)

    Kingo, Pernille Skjold; Nørregaard, Rikke; Borre, Michael; Jensen, Jørgen Bjerggaard

    2017-07-05

    This study aimed to compare clinical outcome and postoperative systemic inflammatory response using C-reactive protein (CRP) levels, to quantify the degree of tissue injury in open mini-laparotomy cystectomy (OMC) versus robot-assisted laparoscopic cystectomy with extracorporeal (RALC-EUD) or intracorporeal urinary diversion (RALC-IUD). From September 2012 to September 2015, 309 patients diagnosed with bladder cancer underwent radical cystectomy with urinary diversion. Of these, 175 patients were eligible for the study and underwent OMC (n = 125), RALC-EUD (n = 12) or RALC-IUD (n = 38). Blood samples were obtained preoperatively and postoperatively on days 1-7. Clinical and perioperative parameters, including demographics, comorbidity, tumour stage and postoperative outcomes, were collected from medical records. Age, American Society of Anesthesiologists score and Charlson score were significantly higher in OMC than in the robotic groups (p = 0.020, 0.012 and 0.008, respectively). Other demographic data showed no significant group differences. Estimated blood loss and blood transfusion volume were higher in OMC (p OMC and RALC-EUD (p OMC CRP levels were higher than RALC-EUD. In this study, robotic techniques seem less traumatic overall than open surgery, as OMC had higher postoperative CRP levels than RALC-EUD. The higher CRP levels in RALC-IUD may be more reflective of the urinary diversion technique than the true tissue trauma.

  8. A prospective international cooperative information technology platform built using open-source tools for improving the access to and safety of bone marrow transplantation in low- and middle-income countries.

    Science.gov (United States)

    Agarwal, Rajat Kumar; Sedai, Amit; Dhimal, Sunil; Ankita, Kumari; Clemente, Luigi; Siddique, Sulman; Yaqub, Naila; Khalid, Sadaf; Itrat, Fatima; Khan, Anwar; Gilani, Sarah Khan; Marwah, Priya; Soni, Rajpreet; Missiry, Mohamed El; Hussain, Mohamed Hamed; Uderzo, Cornelio; Faulkner, Lawrence

    2014-01-01

    Jagriti Innovations developed a collaboration tool in partnership with the Cure2Children Foundation that has been used by health professionals in Italy, Pakistan, and India for the collaborative management of patients undergoing bone marrow transplantation (BMT) for thalassemia major since August 2008. This online open-access database covers data recording, analyzing, and reporting besides enabling knowledge exchange, telemedicine, capacity building, and quality assurance. As of February 2014, over 2400 patients have been registered and 112 BMTs have been performed with outcomes comparable to international standards, but at a fraction of the cost. This approach avoids medical emigration and contributes to local healthcare strengthening and competitiveness. This paper presents the experience and clinical outcomes associated with the use of this platform built using open-source tools and focusing on a locally pertinent tertiary care procedure-BMT. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  9. Comparative Evaluation of the Safety and Efficacy of Long-Term Use of Imidafenacin and Solifenacin in Patients with Overactive Bladder: A Prospective, Open, Randomized, Parallel-Group Trial (the LIST Study

    Directory of Open Access Journals (Sweden)

    Masayoshi Zaitsu

    2011-01-01

    Full Text Available Objectives. Overactive bladder (OAB is a chronic disease, but comparative trials of anticholinergics, which are commonly used for treatment of OAB, have generally been performed for up to 12 weeks only. There is no comparative study of a long-term intervention. Methods. We conducted a 52-week prospective randomized comparative study to evaluate the efficacy and tolerability of two anticholinergics. Results. Forty-one Japanese patients with untreated OAB were randomly assigned to imidafenacin and solifenacin groups. There was no difference in OABSS and KHQ scores between the two groups, but the severity and incidence of adverse events caused by the anticholinergics showed increased differences between the groups with time. The severity of dry mouth and the incidence of constipation were significantly lower in the imidafenacin group (=0.0092 and =0.0013, resp.. Conclusions. This study is the first long-term trial to show differences in the properties of anticholinergics that were not detected in short-term studies. Since OAB is a chronic disease, we conclude that imidafenacin is preferable to solifenacin from a perspective of safety.

  10. Characterizing a fractured aquifer in Mexico using geological attributes related to open-pit groundwater

    Science.gov (United States)

    Herrera, Enrique; Garfias, Jaime

    2013-09-01

    A multivariable analysis of the Rock Quality Designation ( RQD) and its relation with the hydraulic conductivity of 17 dewatering wells in an open-pit mine (central Mexico) is presented as a tool for groundwater exploration in fractured aquifers. A solid model was constructed with the RQD data using three sizes for each grid cell and four interpolation methods. The inverse-distance method with a small grid gives the best results. The resulting RQD solid model was used to locate 22 pilot holes, on which an air-lift test was performed as a qualitative assessment of their usefulness. The results showed a lower water production (1.8 l/s) in shale that has low alteration, whereas in highly altered shale, breccias, and intrusive rock, the flow rate was 3.9 l/s. This implies an important relationship between the pilot-hole performance, the lithology, and the rock alteration, but it was also found that some fractures or faults, which cannot be detected clearly by the RQD, play an important role in the hydrodynamics of the aquifer. In conclusion, it is necessary to consider all available factors that can help to identify the hydrodynamic behavior of the aquifer because using only RQD data can lead to errors in prospecting for groundwater.

  11. Open Images

    DEFF Research Database (Denmark)

    Sanderhoff, Merete

    2013-01-01

    Museums around the world hold enormous troves of public domain artworks. In digitized form, they can be powerful tools for research and learning, as well as building blocks, in the hands of students, teachers, scholars, developers, and creative people. By opening up their digitized assets for reuse......, museums have a unique opportunity to broaden the scope of their public mission to serve and educate the public on 21st century media terms. What could be controversial about that? Art museums have a long legacy of restricting access to high quality images of artworks in order to protect them from improper...

  12. Open University

    CERN Document Server

    Pentz,M

    1975-01-01

    Michel Pentz est née en Afrique du Sud et venu au Cern en 1957 comme physicien et président de l'associaion du personnel. Il est également fondateur du mouvement Antiapartheid de Genève et a participé à la fondation de l'Open University en Grande-Bretagne. Il nous parle des contextes pédagogiques, culturels et nationaux dans lesquels la méthode peut s'appliquer.

  13. Effectiveness of Epidural Analgesia, Continuous Surgical Site Analgesia, and Patient-Controlled Analgesic Morphine for Postoperative Pain Management and Hyperalgesia, Rehabilitation, and Health-Related Quality of Life After Open Nephrectomy: A Prospective, Randomized, Controlled Study.

    Science.gov (United States)

    Capdevila, Xavier; Moulard, Sebastien; Plasse, Christian; Peshaud, Jean-Luc; Molinari, Nicolas; Dadure, Christophe; Bringuier, Sophie

    2017-01-01

    There is no widely recognized effective technique to optimally reduce pain scores and prevent persistent postoperative pain after nephrectomy. We compared continuous surgical site analgesia (CSSA), epidural analgesia (EA), and a control group (patient-controlled analgesic morphine) in patients undergoing open nephrectomy. Sixty consecutive patients were randomized to be part of EA, CSSA, or control groups postoperatively for 72 hours. All patients received patient-controlled analgesic morphine, if needed. Hyperalgesia was assessed on the first, second, and third postoperative days. Chronic pain characteristics and quality of life were analyzed at 1 and 3 months. The primary outcome was the pain score at 24 hours. Secondary outcomes were morphine consumption, postoperative rehabilitation, hyperalgesia, chronic pain incidence, and quality-of-life parameters. At 24 hours, mean ± standard deviation pain values at rest (2.4 ± 1.7, 2.2 ± 1.2, and 4.2 ± 1.2, respectively, in EA, CSSA, and control groups, P control group. Rehabilitation parameters improved sooner in the EA and CSSA groups. Median values of area of hyperalgesia differed at 48 hours between the EA group and the control group (36.4 cm) and (52 cm) (P = .01) and at 72 hours among the EA group, CSSA group, and the control group (40 cm, 39.5 cm, and 59 cm, respectively; P = .002). CSSA reduced the severity of pain and hyperalgesia at 1 month and optimized quality of life 3 months after surgery (role physical scores, P = .005). CSSA and EA significantly improve postoperative analgesia, reduce postoperative morphine consumption, area of wound hyperalgesia, and accelerate patient rehabilitation after open nephrectomy. CSSA significantly reduces the severity of residual pain 1 month after surgery and optimizes quality-of-life parameters 3 months after surgery.

  14. 开源仓储软件在清华大学图书馆的研究应用与思考%Study,Practice and Prospect for Open Source Repository Software's Application in Tsinghua University Library

    Institute of Scientific and Technical Information of China (English)

    曾婷; 董丽; 邹荣; 姜爱蓉

    2012-01-01

    Tsinghua University Library pays lots of attention to the introduction of new technology and idea in the Digital Library System development.We have carried out some in-depth study on the mainstream open-source repository software in recent years,and conducted a series of application development and practice too.This paper will discuss the latest development and our local application practice of two widely used open source repository software-DSpace and Fedora.First,an overview of the latest developments in the two software and their features are introduced.Then,a series of extended application and development about the long-term preservation and institutional repository are presented.At last,we give some thoughts and suggestions about the future construction of local repositories.%清华大学图书馆在数字图书馆系统建设中注重引进新技术和思想,近年来,对国际上主流的开源仓储软件开展了较深入的研究,在本馆进行了一系列应用开发和实践。本文将对应用较多的两个开源仓储软件:DSpace和Fedora的发展和应用实践展开介绍。首先概要介绍两个开源软件的最新发展和特点,再分别介绍本馆在长期保存,机构知识库建设中所作的系列扩展应用和开发,并提出未来构建本地仓储的一些思考和建议。

  15. Pilot Weather Reports

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Aviation weather reports relayed from pilots to FAA air traffic controllers or National Weather Service personnel. Elements include sky cover, turbulence, wind...

  16. CERN pilot greenhouse

    CERN Multimedia

    1983-01-01

    This pilot installation was situated near Bld. BA6 opposite to the main entrance of the Meyrin site, with respect to Route de Meyrin. See Weekly Bulletin 3/83, and also photo 8305594X, 8505898X, 8302200.

  17. Efficacy and safety of a recombinant factor IX (Bax326) in previously treated patients with severe or moderately severe haemophilia B undergoing surgical or other invasive procedures: a prospective, open-label, uncontrolled, multicentre, phase III study.

    Science.gov (United States)

    Windyga, J; Lissitchkov, T; Stasyshyn, O; Mamonov, V; Ghandehari, H; Chapman, M; Fritsch, S; Wong, W-Y; Pavlova, B G; Abbuehl, B E

    2014-09-01

    Haemostatic management of haemophilia B patients undergoing surgery is critical to patient safety. The aim of this ongoing prospective trial was to investigate the haemostatic efficacy and safety of a recombinant factor IX (rFIX) (Bax326) in previously treated subjects (12-65 years, without history of FIX inhibitors) with severe or moderately severe haemophilia B, undergoing surgical, dental or other invasive procedures. Haemostatic efficacy was assessed according to a predefined scale. Blood loss was compared to the average and maximum blood loss predicted preoperatively. Haemostatic FIX levels were achieved peri- and postoperatively in 100% of subjects (n = 14). Haemostasis was 'excellent' intraoperatively in all patients and postoperatively in those without a drain, and 'excellent' or 'good' at the time of drain removal and day of discharge in those with a drain employed. Following the initial dose, the mean FIX activity level rose from 6.55% to 107.58% for major surgeries and from 3.60% to 81.4% for minor surgeries. Actual vs. predicted blood loss matched predicted intraoperative blood loss but was equal to or higher than (but less than 150%) the maximum predicted postoperative blood loss reflecting the severity of procedure and FIX requirements. There were no related adverse events, severe allergic reactions or thrombotic events. There was no evidence that BAX326 increased the risk of inhibitor or binding antibody development to FIX. BAX326 was safe and effective for peri-operative management of 14 subjects with severe and moderately severe haemophilia B.

  18. Twelve-week, prospective, open-label, randomized trial on the effects of an anticholinergic agent or antidiuretic agent as add-on therapy to an alpha-blocker for lower urinary tract symptoms

    Directory of Open Access Journals (Sweden)

    Shin YS

    2014-07-01

    Full Text Available Yu Seob Shin,1 Li Tao Zhang,1 Chen Zhao,2 Young Gon Kim,1 Jong Kwan Park1 1Department of Urology, Chonbuk National University Medical School, and Institute for Medical Sciences, Chonbuk National University and Biomedical Research Institute and Clinical Trial Center of Medical Device of Chonbuk National University Hospital, Jeonju, South Korea; 2Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai Institute of Andrology, Shanghai, People’s Republic of China Purpose: The effects of an anticholinergic or antidiuretic agent as add-on therapy to an ­alpha-blocker for lower urinary tract symptoms (LUTS according to a voiding diary in 3 days are unknown. We prospectively investigated the efficacy of an anticholinergic or antidiuretic agent as add-on therapy for nocturia in men previously treated with an alpha-blocker for LUTS.Subjects and methods: Patients were randomly subdivided into two groups. All patients had a 4-week washout. Group A had alpha-blocker for 4 weeks, then an alpha-blocker plus an anticholinergic agent for 4 weeks, and, finally, 4 weeks of an alpha-blocker plus an antidiuretic agent. Group B had an alpha-blocker for 4 weeks, then an alpha-blocker plus an antidiuretic agent for 4 weeks, and, finally, 4 weeks of an alpha-blocker plus an anticholinergic agent. In both groups, patients were subdivided into nocturnal polyuria, decreased nocturnal bladder capacity (NBC, or nocturia by both causes subgroups. A 3-day voiding diary, total International Prostate Symptom Score (IPSS, IPSS sub-scores, Overactive Bladder Symptom Score, uroflowmetry, and post-void residual urine volume, were assessed at baseline, and at 4, 8, and 12 weeks.Results: A total of 405 patients completed the study. During treatment, the changes from baseline in total IPSS and IPSS sub-scores were significantly decreased at 4 weeks and were maintained for 12 weeks. In the nocturnal polyuria subgroup of Groups A and B

  19. Prospective Primary School Teachers' Perceptions on Boiling and Freezing

    Science.gov (United States)

    Senocak, Erdal

    2009-01-01

    The aim of this study was to investigate the perceptions of prospective primary school teachers on the physical state of water during the processes of boiling and freezing. There were three stages in the investigation: First, open-ended questions concerning the boiling and freezing of water were given to two groups of prospective primary school…

  20. OpenER, a Dutch Initiative in Open Educational Resources

    Science.gov (United States)

    Schuwer, Robert; Mulder, Fred

    2009-01-01

    Over the period 2006-2008, the Dutch Open Universiteit Nederland conducted an experiment in which Open Educational Resources (OER) were offered in an effort to bridge the gap between informal and formal learning and to establish a new style of entry portal to higher education with no barriers at all. OpenER received considerable attention both in…

  1. PULSE Pilot Certification Results

    Directory of Open Access Journals (Sweden)

    Pamela Pape-Lindstrom

    2015-08-01

    Full Text Available The pilot certification process is an ambitious, nationwide endeavor designed to motivate important changes in life sciences education that are in line with the recommendations of the 2011 Vision and Change Report: A Call to Action (American Association for the Advancement of Science [AAAS], 2011.  It is the goal of the certification process to acknowledge departments that have progressed towards full implementation of the tenets of Vision and Change and to motivate departments that have not begun to adopt the recommendations to consider doing so.  More than 70 life science departments applied to be part of the pilot certification process, funded by a National Science Foundation grant, and eight were selected based on initial evidence of transformed and innovative educational practices.  The programs chosen represent a wide variety of schools, including two-year colleges, liberal-arts institutions, regional comprehensive colleges, research universities and minority serving institutions.  Outcomes from this pilot were released June 1, 2015 (www.pulsecommunity.org, with all eight programs being recognized as having progressed along a continuum of change.  Five levels of achievement were defined as PULSE Pilot Progression Levels.  Of the eight departments in the pilot, one achieved “PULSE Progression Level III: Accomplished”.  Six departments achieved “PULSE Progression Level II: Developing” and one pilot department achieved “PULSE Progression Level I: Beginning”.  All of the schools have made significant movement towards the recommendations of Vision and Change relative to a traditional life sciences curriculum.  Overall, the response from the eight pilot schools has been positive. 

  2. Hemodynamic Effects of Phenylephrine, Vasopressin, and Epinephrine in Children With Pulmonary Hypertension: A Pilot Study.

    Science.gov (United States)

    Siehr, Stephanie L; Feinstein, Jeffrey A; Yang, Weiguang; Peng, Lynn F; Ogawa, Michelle T; Ramamoorthy, Chandra

    2016-05-01

    During a pulmonary hypertensive crisis, the marked increase in pulmonary vascular resistance can result in acute right ventricular failure and death. Currently, there are no therapeutic guidelines for managing an acute crisis. This pilot study examined the hemodynamic effects of phenylephrine, arginine vasopressin, and epinephrine in pediatric patients with pulmonary hypertension. In this prospective, open-label, nonrandomized pilot study, we enrolled pediatric patients previously diagnosed with pulmonary hypertensive who were scheduled electively for cardiac catheterization. Primary outcome was a change in the ratio of pulmonary-to-systemic vascular resistance. Baseline hemodynamic data were collected before and after the study drug was administered. Eleven of 15 participants were women, median age was 9.2 years (range, 1.7-14.9 yr), and median weight was 26.8 kg (range, 8.5-55.2 kg). Baseline mean pulmonary artery pressure was 49 ± 19 mm Hg, and mean indexed pulmonary vascular resistance was 10 ± 5.4 Wood units. Etiology of pulmonary hypertensive varied, and all were on systemic pulmonary hypertensive medications. Patients 1-5 received phenylephrine 1 μg/kg; patients 6-10 received arginine vasopressin 0.03 U/kg; and patients 11-15 received epinephrine 1 μg/kg. Hemodynamics was measured continuously for up to 10 minutes following study drug administration. After study drug administration, the ratio of pulmonary-to-systemic vascular resistance decreased in three of five patients receiving phenylephrine, five of five patients receiving arginine vasopressin, and three of five patients receiving epinephrine. Although all three medications resulted in an increase in aortic pressure, only arginine vasopressin consistently resulted in a decrease in the ratio of systolic pulmonary artery-to-aortic pressure. This prospective pilot study of phenylephrine, arginine vasopressin, and epinephrine in pediatric patients with pulmonary hypertensive showed an increase in aortic

  3. Pilot evaluation in TENCompetence: a theory-driven model

    NARCIS (Netherlands)

    Schoonenboom, Judith; Sligte, Henk; Moghnieh, Ayman; Specht, Marcus; Glahn, Christian; Stefanov, Krassen

    2007-01-01

    Schoonenboom, J., Sligte, H., Moghnieh, A., Specht, M., Glahn, C., & Stefanov, K. (2007). Pilot evaluation in TENCompetence: a theory-driven model. In T. Navarette, J. Blat & R. Koper (Eds.). Proceedings of the 3rd TENCompetence Open Workshop 'Current Research on IMS Learning Design and Lifelong Com

  4. Teaching Speech Communication with a Foreign Accent: A Pilot Study.

    Science.gov (United States)

    Chen, Guo-Ming; Chung, Jensen

    A pilot study examined problems encountered by foreign instructors teaching in American colleges. Fourteen Chinese-born instructors teaching in Speech Communication answered a questionnaire containing 12 open-ended questions. Recurring themes were coded from the answers, and then organized into three categories: cultural differences; linguistic…

  5. An open label, randomized, comparative, parallel group, multicenter, prospective, interventional, clinical study to evaluate efficacy and safety of “AHPL/AYTOP/0113” in comparison with “Framycetin sulphate cream” in acute wounds

    Directory of Open Access Journals (Sweden)

    Sanjay U Nipanikar

    2017-01-01

    Full Text Available Objectives: The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. Methodology: It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream. All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier. All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. Results: Group-A subjects took significantly less (P < 0.05 i.e., (mean 7.77 days than (mean 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (P < 0.05 results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. Conclusion: AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds.

  6. NSTAR Smart Grid Pilot

    Energy Technology Data Exchange (ETDEWEB)

    Rabari, Anil [NSTAR Electric, Manchester, NH (United States); Fadipe, Oloruntomi [NSTAR Electric, Manchester, NH (United States)

    2014-03-31

    NSTAR Electric & Gas Corporation (“the Company”, or “NSTAR”) developed and implemented a Smart Grid pilot program beginning in 2010 to demonstrate the viability of leveraging existing automated meter reading (“AMR”) deployments to provide much of the Smart Grid functionality of advanced metering infrastructure (“AMI”), but without the large capital investment that AMI rollouts typically entail. In particular, a central objective of the Smart Energy Pilot was to enable residential dynamic pricing (time-of-use “TOU” and critical peak rates and rebates) and two-way direct load control (“DLC”) by continually capturing AMR meter data transmissions and communicating through customer-sited broadband connections in conjunction with a standardsbased home area network (“HAN”). The pilot was supported by the U.S. Department of Energy’s (“DOE”) through the Smart Grid Demonstration program. NSTAR was very pleased to not only receive the funding support from DOE, but the guidance and support of the DOE throughout the pilot. NSTAR is also pleased to report to the DOE that it was able to execute and deliver a successful pilot on time and on budget. NSTAR looks for future opportunities to work with the DOE and others in future smart grid projects.

  7. Openness initiative

    Energy Technology Data Exchange (ETDEWEB)

    Duncan, S.S. [Los Alamos National Lab., NM (United States)

    1995-12-31

    Although antinuclear campaigns seem to be effective, public communication and education efforts on low-level radioactive waste have mixed results. Attempts at public information programs on low-level radioactive waste still focus on influencing public opinion. A question then is: {open_quotes}Is it preferable to have a program focus on public education that will empower individuals to make informed decisions rather than trying to influence them in their decisions?{close_quotes} To address this question, a case study with both quantitative and qualitative data will be used. The Ohio Low-Level Radioactive Waste Education Program has a goal to provide people with information they want/need to make their own decisions. The program initiated its efforts by conducting a statewide survey to determine information needed by people and where they turned for that information. This presentation reports data from the survey and then explores the program development process in which programs were designed and presented using the information. Pre and post data from the programs reveal attitude and knowledge shifts.

  8. Gallbladder removal - open

    Science.gov (United States)

    Cholecystectomy - open; Surgery - gallbladder - open ... a medical instrument called a laparoscope ( laparoscopic cholecystectomy ). Open gallbladder surgery is used when laparoscopic surgery cannot ...

  9. Service Catalog Pilot Project Summary

    Data.gov (United States)

    US Fish and Wildlife Service, Department of the Interior — This report summarizes the ServCat pilot project and offers recommendations for the full-scale implementation of the database. During the pilot project a total of...

  10. Bessie Coleman, First African American Pilot

    Science.gov (United States)

    1921-01-01

    Born on January 26, 1892 in Atlanta, Texas to a family of sharecroppers, Bessie Coleman grew up in poverty. Her father abandoned the family when she was nine, and her elder brothers soon left as well, leaving her mother with the four youngest of her thirteen children. While taking care of her younger sisters, Bessie completed all eight available years of primary education, excelling in math. She enrolled at the Colored Agricultural and Normal University in Langston, Oklahoma in 1910, but lack of funds forced her to leave after only one term. Five years later, she left the South and moved to Chicago to join two of her brothers, Walter and John, where she worked as a beautician for several years. An avid reader, she learned about World War I pilots in the newspaper and became intrigued by the prospect of flying. As a black woman, she had no chance of acceptance at any American pilot school, so she moved to France in 1919 and enrolled at the Ecole d'Aviation des Freres Caudon at Le Crotoy. After returning briefly to the United States, she spent one more term in France practicing more advanced flying before finally settling back in her birth country. She did exhibition flying and gave lectures across the country from 1922 to 1926. While flying, she refused to perform unless the audiences were desegregated. She was test flying a new plane on April 30, 1926 when it malfunctioned, killing both her and the mechanic who was piloting it. Her career as the world's first African American pilot inspired many who followed.

  11. Opening Address

    Science.gov (United States)

    Crovini, L.

    1994-01-01

    Ladies and Gentlemen To quote Mr Jean Terrien: "Physics must be one step ahead of metrology". A long-serving Director of the BIPM, he said these words when visiting the IMGC in 1970 as a member of the scientific board of our Institute. At that time it was still an open question whether the IMGC should start research work on the absolute measurement of silicon lattice spacing. Mr Terrien underlined the revolutionary character of x-ray interferometry and, eventually, he caused the balance needle to lean towards the ... right direction. Mr Terrien correctly foresaw that, like Michelson's interferometer of 1880, x-ray interferometry could have a prominent place in today's science and technology. And while, in the first case, after more than a century we can see instruments based on electromagnetic wave interaction within every one's reach in laboratories and, sometimes, in workshops, in the second case, twenty-five years since the first development of an x-ray interferometer we can witness its role in nanometrology. Today and tomorrow we meet to discuss how to go beyond the sixth decimal place in the value of the Avogadro constant. We are aware that the quest for this achievement requires the cooperation of scientists with complementary capabilities. I am sure that the present workshop is a very good opportunity to present and discuss results and to improve and extend existing cooperation. The new adjustment of fundamental constants envisaged by the CODATA Task Group is redoubling scientists' efforts to produce competitive values of NA. The results of the measurements of the silicon lattice spacing in terms of an optical wavelength, which were available for the 1986 adjustment, combined with the determination of silicon molar volume, demonstrate how such an NA determination produces a consistent set of other constants and opens the way to a possible redefinition of the kilogram. We shall see in these two days how far we have progressed along this road. For us at the

  12. Microbial field pilot study

    Energy Technology Data Exchange (ETDEWEB)

    Knapp, R.M.; McInerney, M.J.; Menzie, D.E.; Coates, J.D.; Chisholm, J.L.

    1993-05-01

    A multi-well microbially enhanced oil recovery field pilot has been performed in the Southeast Vassar Vertz Sand Unit in Payne County, Oklahoma. The primary emphasis of the experiment was preferential plugging of high permeability zones for the purpose of improving waterflood sweep efficiency. Studies were performed to determine reservoir chemistry, ecology, and indigenous bacteria populations. Growth experiments were used to select a nutrient system compatible with the reservoir that encouraged growth of a group of indigenous nitrate-using bacteria and inhibit growth of sulfate-reducing bacteria. A specific field pilot area behind an active line drive waterflood was selected. Surface facilities were designed and installed. Injection protocols of bulk nutrient materials were prepared to facilitate uniform distribution of nutrients within the pilot area. By the end of December, 1991, 82.5 tons (75.0 tonnes) of nutrients had been injected in the field. A tracer test identified significant heterogeneity in the SEVVSU and made it necessary to monitor additional production wells in the field. The tracer tests and changes in production behavior indicate the additional production wells monitored during the field trial were also affected. Eighty two and one half barrels (13.1 m[sup 3]) of tertiary oil have been recovered. Microbial activity has increased CO[sub 2] content as indicated by increased alkalinity. A temporary rise in sulfide concentration was experienced. These indicate an active microbial community was generated in the field by the nutrient injection. Pilot area interwell pressure interference test results showed that significant permeability reduction occurred. The interwell permeabilities in the pilot area between the injector and the three pilot production wells were made more uniform which indicates a successful preferential plugging enhanced oil recovery project.

  13. Atomoxetine Open-Label Trial in ADHD

    Directory of Open Access Journals (Sweden)

    J Gordon Millichap

    2002-07-01

    Full Text Available Atomoxetine (originally named tomoxetine, a new therapy for attention deficit hyperactivity disorder (ADHD marketed by Eli Lilly, was compared to methylphenidate in a prospective, randomized, open-label study for 10 weeks duration, at the University of Nebraska Medical Center, Massachusetts General Hospital, Mount Sinai Medical Center, Carolinas Medical Center, and Lilly Research Laboratories.

  14. Improving Open Access through Prior Learning Assessment

    Science.gov (United States)

    Yin, Shuangxu; Kawachi, Paul

    2013-01-01

    This paper explores and presents new data on how to improve open access in distance education through using prior learning assessments. Broadly there are three types of prior learning assessment (PLAR): Type-1 for prospective students to be allowed to register for a course; Type-2 for current students to avoid duplicating work-load to gain…

  15. Open life science research, open software and the open century

    Institute of Scientific and Technical Information of China (English)

    Youhua Chen

    2015-01-01

    At the age of knowledge explosion and mass scientific information, I highlighted the importance of conducting open science in life and medical researches through the extensive usage of open software and documents. The proposal of conducting open science is to reduce the limited repeatability of researches in life science. I outlined the essential steps for conducting open life science and the necessary standards for creating, reusing and reproducing open materials. Different Creative Commons licenses were presented and compared of their usage scope and restriction. As a conclusion, I argued that open materials should be widely adopted in doing life and medical researches.

  16. PILOT optical alignment

    Science.gov (United States)

    Longval, Y.; Mot, B.; Ade, P.; André, Y.; Aumont, J.; Baustista, L.; Bernard, J.-Ph.; Bray, N.; de Bernardis, P.; Boulade, O.; Bousquet, F.; Bouzit, M.; Buttice, V.; Caillat, A.; Charra, M.; Chaigneau, M.; Crane, B.; Crussaire, J.-P.; Douchin, F.; Doumayrou, E.; Dubois, J.-P.; Engel, C.; Etcheto, P.; Gélot, P.; Griffin, M.; Foenard, G.; Grabarnik, S.; Hargrave, P..; Hughes, A.; Laureijs, R.; Lepennec, Y.; Leriche, B.; Maestre, S.; Maffei, B.; Martignac, J.; Marty, C.; Marty, W.; Masi, S.; Mirc, F.; Misawa, R.; Montel, J.; Montier, L.; Narbonne, J.; Nicot, J.-M.; Pajot, F.; Parot, G.; Pérot, E.; Pimentao, J.; Pisano, G.; Ponthieu, N.; Ristorcelli, I.; Rodriguez, L.; Roudil, G.; Salatino, M.; Savini, G.; Simonella, O.; Saccoccio, M.; Tapie, P.; Tauber, J.; Torre, J.-P.; Tucker, C.

    2016-07-01

    PILOT is a balloon-borne astronomy experiment designed to study the polarization of dust emission in the diffuse interstellar medium in our Galaxy at wavelengths 240 μm with an angular resolution about two arcminutes. Pilot optics is composed an off-axis Gregorian type telescope and a refractive re-imager system. All optical elements, except the primary mirror, are in a cryostat cooled to 3K. We combined the optical, 3D dimensional measurement methods and thermo-elastic modeling to perform the optical alignment. The talk describes the system analysis, the alignment procedure, and finally the performances obtained during the first flight in September 2015.

  17. Pilot selection and training

    Science.gov (United States)

    Helmreich, Robert L.

    1982-01-01

    Personality and situational factors relevant to individual and group performance in highly demanding environments, such as those faced by astronauts or by jet transport crew, are discussed. It is emphasized that although technical competence and proficiency in pilot selection are prerequisites for safety, operating a modern jet transport is a group endeavor that requires the effective coordination of the entire crew. A self-report test battery for measuring positive and negative personality traits of pilot candidates, termed the Personal Characteristics Inventory, is described.

  18. Open life science research, open software and the open century

    National Research Council Canada - National Science Library

    Youhua Chen

    2015-01-01

    At the age of knowledge explosion and mass scientific information, I highlighted the importance of conducting open science in life and medical researches through the extensive usage of open software and documents...

  19. Operating a production pilot factory serving several scientific domains

    Science.gov (United States)

    Sfiligoi, I.; Würthwein, F.; Andrews, W.; Dost, J. M.; MacNeill, I.; McCrea, A.; Sheripon, E.; Murphy, C. W.

    2011-12-01

    Pilot infrastructures are becoming prominent players in the Grid environment. One of the major advantages is represented by the reduced effort required by the user communities (also known as Virtual Organizations or VOs) due to the outsourcing of the Grid interfacing services, i.e. the pilot factory, to Grid experts. One such pilot factory, based on the glideinWMS pilot infrastructure, is being operated by the Open Science Grid at University of California San Diego (UCSD). This pilot factory is serving multiple VOs from several scientific domains. Currently the three major clients are the analysis operations of the HEP experiment CMS, the community VO HCC, which serves mostly math, biology and computer science users, and the structural biology VO NEBioGrid. The UCSD glidein factory allows the served VOs to use Grid resources distributed over 150 sites in North and South America, in Europe, and in Asia. This paper presents the steps taken to create a production quality pilot factory, together with the challenges encountered along the road.

  20. Open Standards, Open Source, and Open Innovation: Harnessing the Benefits of Openness

    Science.gov (United States)

    Committee for Economic Development, 2006

    2006-01-01

    Digitization of information and the Internet have profoundly expanded the capacity for openness. This report details the benefits of openness in three areas--open standards, open-source software, and open innovation--and examines the major issues in the debate over whether openness should be encouraged or not. The report explains each of these…

  1. User Participation in Pilot Implementation

    DEFF Research Database (Denmark)

    Torkilsheyggi, Arnvør Martinsdóttir á; Hertzum, Morten

    2014-01-01

    implementation as a method for participatory design. We find that to foster participation and learning about user needs a pilot implementation must create a space for reflecting on use, in addition to the space for using the pilot system. The space for reflection must also exist during the activities preparing...... the use of the pilot system because the porters and nurses learned about their needs throughout the pilot implementation, not just during use. Finally, we discuss how the scope and duration of a pilot implementation influence the conditions for participation....

  2. Evaluatie pilot elektronische volgsystemen

    NARCIS (Netherlands)

    Miedema, F.; Post, B.

    2006-01-01

    Naast het uitvoeren van een onderzoek naar de ervaringen met EVS (Elektronisch Volgsysteem) in het buitenland, worden er bij de sectoren GW (Gevangeniswezen), jeugd en tbs een aantal pilot-projecten opgestart waarbij gebruik wordt gemaakt van elektronische volgsystemen met GPS-techniek (GPS = Global

  3. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus; Ie Pedersen, Maria

    Abstract. We report on the initial findings of an action research study about effects specifications. It is a part of larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews and a workshop we have identified and specified the main effects that comprise...

  4. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus Rotvit Perlt; Pedersen, Maria Ie

    2011-01-01

    Abstract. We report on the initial findings of an exploratory action research study about effects specifications using the systems development method Effects-driven IT development. It is part of a larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews...

  5. Pilot project as enabler?

    DEFF Research Database (Denmark)

    Neisig, Margit; Glimø, Helle; Holm, Catrine Granzow;

    This article deals with a systemic perspective on transition. The field of study addressed is a pilot project as enabler of transition in a highly complex polycentric context. From a Luhmannian systemic approach, a framework is created to understand and address barriers of change occurred using p...

  6. [Do pilots need stereopsis ?].

    Science.gov (United States)

    Diepgen, R

    1993-02-01

    Pilots so far are required to have a good quality of stereopsis. Many people do not meet this requirement. But is this requirement justified by research in aviation medicine and psychology of perception? This question is discussed on the basis of the theoretical and empirical literature. The answer is: No.

  7. Evaluatie pilot Endogene Factoren

    NARCIS (Netherlands)

    Viet AL; Fiolet D; Voortman JK; Rover C de; Hanning C; Uitenbroek D; Loon AJM van; PZO; GGD Achterhoek; GGD Midden Holland; GG&GD Amsterdam

    2004-01-01

    As a part of the project on the Local and National Monitor for Public Health several pilot studies were carried out in three Municipal Health Centres (GGDs). The first aim was to investigate the feasibility of a physical examination at the health centre in combination with a health interview (or pos

  8. Priming a Pilot Implementation

    DEFF Research Database (Denmark)

    Hansen, Magnus; Ie Pedersen, Maria

    Abstract. We report on the initial findings of an action research study about effects specifications. It is a part of larger IS pilot implementation project conducted in the Danish healthcare sector. Through interviews and a workshop we have identified and specified the main effects that comprise...

  9. Effects of a structured 20-session slow-cortical-potential-based neurofeedback program on attentional performance in children and adolescents with attention-deficit hyperactivity disorder: retrospective analysis of an open-label pilot-approach and 6-month follow-up

    Science.gov (United States)

    Albrecht, Johanna S; Bubenzer-Busch, Sarah; Gallien, Anne; Knospe, Eva Lotte; Gaber, Tilman J; Zepf, Florian D

    2017-01-01

    obtained preliminary data are the rather small sample size, the lack of a control group/a placebo condition and the open-label approach because of the clinical setting and retrospective analysis. The value of the current approach lies in providing pilot data for future studies involving larger samples. PMID:28293109

  10. Content and Language Integrated Learning in Opensimulator Project. Results of a Pilot Implementation in Greece

    Science.gov (United States)

    Fokides, Emmanuel; Zampouli, Constantina

    2017-01-01

    The study presents the results of a pilot implementation of the Content and Language Integrated Learning in OpenSimulator Project-CLILiOP. Content and Language Integrated Learning together with constructivism provided the theoretical basis of the project. A multi-user virtual environment was developed using OpenSimulator, which entailed a tour of…

  11. A Prospective Study of Serotonin and Norepinephrine Transporter Genes and the Response to Desvenlafaxine Over 8 Weeks in Major Depressive Disorder.

    Science.gov (United States)

    Ng, C H; Bousman, C; Smith, D J; Dowling, N; Byron, K; King, J; Sarris, J

    2016-09-01

    No studies to date have evaluated SLC6A2 and SLC6A4 genetic polymorphisms influencing antidepressant response to desvenlafaxine. We conducted an 8-week, open-label, prospective pilot study in 35 patients with major depressive disorder to assess the effects of genetic variations in SLC6A2 and SLC6A4 on both efficacy and side effect profile of desvenlafaxine. Results revealed that homozygotes for the SLC6A4 HTTLPR S allele showed a 33% HDRS reduction compared to a 58% reduction for L allele carriers (p=0.037). No results survived adjustments for covariates or multiple comparisons. While these results need to be interpreted cautiously, they provide preliminary support for the SLC6A4 HTTLPR polymorphism as potential modifier of desvenlafaxine efficacy. © Georg Thieme Verlag KG Stuttgart · New York.

  12. Psychophysiology of prospective memory.

    Science.gov (United States)

    Rothen, Nicolas; Meier, Beat

    2014-01-01

    Prospective memory involves the self-initiated retrieval of an intention upon an appropriate retrieval cue. Cue identification can be considered as an orienting reaction and may thus trigger a psychophysiological response. Here we present two experiments in which skin conductance responses (SCRs) elicited by prospective memory cues were compared to SCRs elicited by aversive stimuli to test whether a single prospective memory cue triggers a similar SCR as an aversive stimulus. In Experiment 2 we also assessed whether cue specificity had a differential influence on prospective memory performance and on SCRs. We found that detecting a single prospective memory cue is as likely to elicit a SCR as an aversive stimulus. Missed prospective memory cues also elicited SCRs. On a behavioural level, specific intentions led to better prospective memory performance. However, on a psychophysiological level specificity had no influence. More generally, the results indicate reliable SCRs for prospective memory cues and point to psychophysiological measures as valuable approach, which offers a new way to study one-off prospective memory tasks. Moreover, the findings are consistent with a theory that posits multiple prospective memory retrieval stages.

  13. PILOT DECONTAMINATION THROUGH PILOT SEQUENCE HOPPING IN MASSIVE MIMO SYSTEMS

    DEFF Research Database (Denmark)

    2015-01-01

    The invention relates to a system for determining channel coefficients of channels in a wireless cellular network. The wireless cellular network comprises a plurality of cells wherein each cell comprises a base station configured to communicate with users within the cell and wherein a communication...... path between one of the users and one of the base stations define one of the channels. The system comprises a pilot generation unit configured to assign pilot sequences randomly among the users and a pilot processing unit configured to filter the pilot sequences received from a user of interest so...... that the channel coefficient of the channel of the user of interest is determined. The pilot sequences received from the user of interest are contaminated by other non-orthogonal or identical pilot sequences from other users of the cell of interest or other cells. The filter is configured so that the contamination...

  14. HOPE: An On-Line Piloted Handling Qualities Experiment Data Book

    Science.gov (United States)

    Jackson, E. B.; Proffitt, Melissa S.

    2010-01-01

    A novel on-line database for capturing most of the information obtained during piloted handling qualities experiments (either flight or simulated) is described. The Hyperlinked Overview of Piloted Evaluations (HOPE) web application is based on an open-source object-oriented Web-based front end (Ruby-on-Rails) that can be used with a variety of back-end relational database engines. The hyperlinked, on-line data book approach allows an easily-traversed way of looking at a variety of collected data, including pilot ratings, pilot information, vehicle and configuration characteristics, test maneuvers, and individual flight test cards and repeat runs. It allows for on-line retrieval of pilot comments, both audio and transcribed, as well as time history data retrieval and video playback. Pilot questionnaires are recorded as are pilot biographies. Simple statistics are calculated for each selected group of pilot ratings, allowing multiple ways to aggregate the data set (by pilot, by task, or by vehicle configuration, for example). Any number of per-run or per-task metrics can be captured in the database. The entire run metrics dataset can be downloaded in comma-separated text for further analysis off-line. It is expected that this tool will be made available upon request

  15. Sandia OpenSHMEM

    Energy Technology Data Exchange (ETDEWEB)

    2016-03-15

    Sandia OpenSHMEM is an implementation of the OpenSHMEM Standard over the Portals 4 Networking API and the OpenFabrics Interface (OFI). Sandia OpenSHMEM is designed to be a low-overhead implementation of the OpenSHMEM standard which takes advantage of the many features of the Portals 4 specification.

  16. Open-Label Memantine in Fragile X Syndrome

    Science.gov (United States)

    Erickson, Craig A.; Mullett, Jennifer E.; McDougle, Christopher J.

    2009-01-01

    Glutamatergic dysfunction is implicated in the pathophysiology of fragile X syndrome (FXS). The purpose of this pilot study was to examine the effectiveness and tolerability of memantine for a number of target symptoms associated with FXS. Medical records describing open-label treatment with memantine in 6 patients with FXS and a comorbid…

  17. Open access, open education resources and open data in Uganda.

    Science.gov (United States)

    Salvo, Ivana Di; Mwoka, Meggie; Kwaga, Teddy; Rukundo, Priscilla Aceng; Ernest, Dennis Ssesanga; Osaheni, Louis Aikoriogie; John, Kasibante; Shafik, Kasirye; de Sousa, Agostinho Moreira

    2015-01-01

    As a follow up to OpenCon 2014, International Federation of Medical Students' Associations (IFMSA) students organized a 3 day workshop Open Access, Open Education Resources and Open Data in Kampala from 15-18 December 2014. One of the aims of the workshop was to engage the Open Access movement in Uganda which encompasses the scientific community, librarians, academia, researchers and students. The IFMSA students held the workshop with the support of: Consortium for Uganda University Libraries (CUUL), The Right to Research Coalition, Electronic Information for Libraries (EIFL), Makerere University, International Health Sciences University (IHSU), Pan African Medical Journal (PAMJ) and the Centre for Health Human Rights and Development (CEHURD). All these organizations are based or have offices in Kampala. The event culminated in a meeting with the Science and Technology Committee of Parliament of Uganda in order to receive the support of the Ugandan Members of Parliament and to make a concrete change for Open Access in the country.

  18. Agricultural Pilot's Audiological Profile

    Directory of Open Access Journals (Sweden)

    Foltz, Lucas

    2010-09-01

    Full Text Available Introduction: The agricultural airplane pilot are daily exposed to intense noises, being susceptible to the noise-induced hearing loss (NIHL and its auditory and extra auditory effects. Objective: To analyze the audiological profile of this population, verifying the work's influence on its hearing. Method: It was realized a retrospective, individual, observational, and cross-sectional study through the data obtained by means of a questionnaire and audiometric thresholds of 41 agricultural pilots. To the statistical analysis were utilized the chi-square, Spearman, and Wilcoxon tests with significance level of 5%. Results: It was verified that 95,1% of the pilots use PPE ( personal protective equipment during flight and 58,5% have contact with pesticides. More than half of individuals referred to feel auditory and extra auditory symptoms, being the buzz the more frequent (29,1%. It has the occurrence of 29,3% of NIHL suggestive hearing loss and 68,3% of normality, taking this presence of unilateral notch in 24,4% and bilateral notch in 31,7%. It was found correlation statistically significant in the associations between time of service and the average of the acute frequencies in the right ear (p=0038, and in the left ear (p=0,010. It has a statistical tendency in the association between audiometric configuration and contact with pesticides (p=0,088. Conclusion: The hearing loss prevalence in this study was showed high. More than half of the sample has normal audiometric thresholds with notch configuration. Such data lead to the conclusion that the agricultural pilots, even with PPE use, they still suffer with the damages caused by noise, needing best proposals of hearing loss prevention.

  19. The fighter pilot's egg

    Science.gov (United States)

    Fry, Dale W.

    1990-03-01

    Of common interest to fighter pilots is what maneuver should be flown to accomplish a 360° heading change in the least time. Among the infinite possibilities, analytic expressions for a very commonly used maneuver, a roughly circular planar turn that accomplishes the required heading change, are derived and examined under four realistic assumptions. Contrary to common belief, the time to complete the stated heading change turns out to be independent of the inclination of the plane of the turn.

  20. Pilot Candidate Selection

    Science.gov (United States)

    1989-05-01

    pilot selection system and to best support up-front track selection for SUPT? Assumptions The USAF Trainer Masterplan does not include a plan to...replace the T-41 with a new flight screening aircraft. In addition, the Masterplan states that candidates will be track selected prior to entry into primary...training. (3:10) While the Masterplan is not a static document and aircraft procurement plans and/or the timing of track selection are subject to

  1. Pilots 2.0: DIRAC pilots for all the skies

    Science.gov (United States)

    Stagni, F.; Tsaregorodtsev, A.; McNab, A.; Luzzi, C.

    2015-12-01

    In the last few years, new types of computing infrastructures, such as IAAS (Infrastructure as a Service) and IAAC (Infrastructure as a Client), gained popularity. New resources may come as part of pledged resources, while others are opportunistic. Most of these new infrastructures are based on virtualization techniques. Meanwhile, some concepts, such as distributed queues, lost appeal, while still supporting a vast amount of resources. Virtual Organizations are therefore facing heterogeneity of the available resources and the use of an Interware software like DIRAC to hide the diversity of underlying resources has become essential. The DIRAC WMS is based on the concept of pilot jobs that was introduced back in 2004. A pilot is what creates the possibility to run jobs on a worker node. Within DIRAC, we developed a new generation of pilot jobs, that we dubbed Pilots 2.0. Pilots 2.0 are not tied to a specific infrastructure; rather they are generic, fully configurable and extendible pilots. A Pilot 2.0 can be sent, as a script to be run, or it can be fetched from a remote location. A pilot 2.0 can run on every computing resource, e.g.: on CREAM Computing elements, on DIRAC Computing elements, on Virtual Machines as part of the contextualization script, or IAAC resources, provided that these machines are properly configured, hiding all the details of the Worker Nodes (WNs) infrastructure. Pilots 2.0 can be generated server and client side. Pilots 2.0 are the “pilots to fly in all the skies”, aiming at easy use of computing power, in whatever form it is presented. Another aim is the unification and simplification of the monitoring infrastructure for all kinds of computing resources, by using pilots as a network of distributed sensors coordinated by a central resource monitoring system. Pilots 2.0 have been developed using the command pattern. VOs using DIRAC can tune pilots 2.0 as they need, and extend or replace each and every pilot command in an easy way. In this

  2. 14 CFR 61.73 - Military pilots or former military pilots: Special rules.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false Military pilots or former military pilots... Ratings and Pilot Authorizations § 61.73 Military pilots or former military pilots: Special rules. (a... a disciplinary action involving aircraft operations, a U.S. military pilot or former military...

  3. 76 FR 19267 - Pilot, Flight Instructor, and Pilot School Certification; Technical Amendment

    Science.gov (United States)

    2011-04-07

    ... Administration 14 CFR Part 61 RIN 2120-AI86 Pilot, Flight Instructor, and Pilot School Certification; Technical... for pilots, flight instructors, ground instructors, and pilot schools. This document reinstates two... entitled, ``Pilot, Flight Instructor, and Pilot School Certification; Final Rule'' (74 FR 42500). That...

  4. Clinical spectrum and complications of scrub typhus: a single-centre, pilot observation from central India

    Directory of Open Access Journals (Sweden)

    Jay Deshmukh

    2016-11-01

    Conclusions: Our pilot observation suggests scrub typhus is common in females and in younger age groups. These findings need further exploration in a large, prospective, trial in confirmed cases of scrub typhus. [Int J Res Med Sci 2016; 4(11.000: 4898-4902

  5. A clinical pilot study of fresh frozen plasma versus human albumin in paediatric craniofacial repair

    NARCIS (Netherlands)

    Kerner, T.; Machottas, A.; Kerner, S.; Ahlers, O.; Haberl, H.; Riess, H.; Hildebrandt, B.

    2008-01-01

    Poediatric craniofacial surgery (pCFS) regularly requires transfusion of packed red blood cells (pRBC). In this clinical pilot study two different transfusion regimens were prospectively compared concerning pRBC transfusions, postoperative bleeding and other clinical parameters. Thirty infants (aged

  6. Potentiality of Disaster Management Education through Open and Distance Learning System in Bangladesh Open University

    Science.gov (United States)

    Ahmad, Saima; Numan, Sharker Md.

    2015-01-01

    Bangladesh Open University (BOU) is the only public educational institution in Bangladesh, where, a dual-mode method of learning system has been introduced. Established in 21st October, 1992, the University now accommodates 174,459 learners in 2012. The wide range networking of this university provides it a great prospect to execute a broad…

  7. Rosiglitazone Add-On in Treatment of Depressed Patients with Insulin Resistance: a Pilot Study

    Directory of Open Access Journals (Sweden)

    Natalie L. Rasgon

    2010-01-01

    Full Text Available A number of cross-sectional studies have suggested an association between insulin resistance (IR and affective disorders. However, limited data exist on potential changes in IR in a prospective treatment of depression. The present pilot study tested the hypothesis that improvement of IR with the addition of an insulin-sensitizing agent would improve mood in nondiabetic patients with unipolar or bipolar depression, who had surrogate blood markers suggestive of IR. Surrogate IR-criteria blood markers were fasting plasma glucose >100 mg/dl or triglyceride (TG to high density lipoprotein (HDL ratio >3.0. Open-label rosiglitazone, titrated to a dose of 8 mg/day, was administered for 12 weeks to 12 patients with depressive disorder receiving treatment as usual (TAU. Eight patients who completed the 12-week study exhibited significant declines in both depression severity by the Hamilton Depression Rating Scale and the Clinical Global Impression scale, with moderate effect sizes noted. Modest improvement in Matsuda Index scores was also noted at 12 weeks, yet declines in depression severity scores were not associated with improvements in the endocrine markers (Matsuda Index, TG/HDL ratio, and body mass index. These results suggest the potential novel use for an insulin-sensitizing agent in the treatment of depressive disorders. Larger placebo-controlled studies are warranted.

  8. Estudo prospectivo e comparativo dos resultados funcionais após reparo aberto e artroscópico das lesões do manguito rotador Prospective and comparative study on functional outcomes after open and arthroscopic repair of rotator cuff tears

    Directory of Open Access Journals (Sweden)

    Marco Antônio de Castro Veado

    2011-10-01

    Full Text Available OBJETIVO: Avaliar prospectivamente o resultado cirúrgico dos pacientes submetidos ao reparo das lesões do manguito rotador por via aberta e artroscópica, quanto ao aspecto funcional, clínico e por exame de ultrassonografia (US, além de comparar a ocorrência de reruptura. MÉTODOS: Foram operados 60 pacientes pelo mesmo cirurgião, sendo 29 pacientes por via aberta e 31 por via artroscópica para reparo das lesões completas do manguito rotador (MR, entre agosto de 2007 e fevereiro de 2009 no Hospital Governador Israel Pinheiro (HGIP e Hospital Mater Dei (HMD em Belo Horizonte, MG. Os pacientes foram avaliados funcionalmente através do escore da UCLA feito no pré e no pós-operatório e exames de ressonância magnética realizados no pré-operatório. Todos os pacientes foram reavaliados com um período mínimo de 12 meses de pós-operatório, quando foi realizado também exame de US. RESULTADOS: Dos 29 pacientes operados por via aberta, 27 (93,1% apresentaram resultados bons/excelentes, com UCLA médio de 32 no pós-operatório. O seguimento médio foi de 14 meses. Três pacientes apresentaram reruptura ao US, sendo que um deles permaneceu assintomático. Dos 31 pacientes operados por via artroscópica, 29 (93,5% apresentaram resultados bons/excelentes, com UCLA médio de 33 no pós-operatório. O seguimento médio foi de 19 meses. Dois pacientes apresentaram reruptura, sendo que um deles permaneceu assintomático, e um paciente evoluiu com soltura de âncora com resultado insatisfatório. CONCLUSÃO: O reparo das lesões do manguito rotador apresenta bons resultados tanto por via aberta como artroscópica, com resultados funcionais semelhantes entre os grupos, bem como a taxa de reruptura.OBJECTIVE: To prospectively assess the surgical results from patients undergoing repairs to rotator cuff injuries via open and arthroscopic procedures, with regard to functional and clinical features, and by means of ultrasound examinations, and to

  9. Open heart surgery

    Science.gov (United States)

    Heart surgery - open ... lung machine is used in most cases during open heart surgery. While the surgeon works on the ... with these procedures, the surgeon may have to open the chest to do the surgery.

  10. LANCELOT pilot report, June 2007

    DEFF Research Database (Denmark)

    Levinsen, Karin; Meyer, Bente

    The aim of the Lancelot pilot evaluation process was to understand how teachers learn to teach and to relate to the online environment through the specific context of the Lancelot live online course. Following the Action Research in the autumn of 2006 the LANCELOT live online language course...... was revised for the piloting in the spring of 2007. A second aim of the pilot evaluation has therefore been to assess the revision of the course following the Action Research....

  11. Apraxia of lid opening

    Directory of Open Access Journals (Sweden)

    Jebasingh Y

    2006-01-01

    Full Text Available Apraxia of lid opening is a condition where patients do not have ptosis but have difficulty in overcoming levator palpebrae inhibition. We report a patient who presented with difficulty in opening eyelids with out diurnal variation, ptosis or blepharospasm. The diagnosis of Apraxia of lid opening is confirmed by electro physiology. The possibility of apraxia of lid opening should be considered in patients who present with difficulty in opening eyes. Various causes of Apraxia of lid opening are discussed.

  12. Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: rheumatoid arthritis with orencia trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial-an open-label, one-year, prospective study-Interim analysis of 32 patients for 24 weeks.

    Science.gov (United States)

    Tsuboi, Hiroto; Matsumoto, Isao; Hagiwara, Shinya; Hirota, Tomoya; Takahashi, Hiroyuki; Ebe, Hiroshi; Yokosawa, Masahiro; Hagiya, Chihiro; Asashima, Hiromitsu; Takai, Chinatsu; Miki, Haruka; Umeda, Naoto; Kondo, Yuya; Ogishima, Hiroshi; Suzuki, Takeshi; Hirata, Shintaro; Saito, Kazuyoshi; Tanaka, Yoshiya; Horai, Yoshiro; Nakamura, Hideki; Kawakami, Atsushi; Sumida, Takayuki

    2015-03-01

    Abstract Objective. To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods. The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results. Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased from 2945 ± 2090 (0 week) to 3419 ± 2121 (24 weeks) mg/2 min (P < 0.05). Schirmer's test for tear volume showed increase from 3.6 ± 4.6 (0 week) to 5.5 ± 7.1 (24 weeks) mm/5 min (n = 25; P < 0.05). Five adverse events occurred in five of 32 patients (15.6%), and three of these events were infections. Conclusion. Abatacept seems to be effective for both RA and RA-related secondary SS.

  13. Efficacy and safety of abatacept for patients with Sjögren's syndrome associated with rheumatoid arthritis: Rheumatoid Arthritis with Orencia Trial toward Sjögren's syndrome Endocrinopathy (ROSE) trial—an open-label, one-year, prospective study—Interim analysis of 32 patients for 24 weeks

    Science.gov (United States)

    Tsuboi, Hiroto; Matsumoto, Isao; Hagiwara, Shinya; Hirota, Tomoya; Takahashi, Hiroyuki; Ebe, Hiroshi; Yokosawa, Masahiro; Hagiya, Chihiro; Asashima, Hiromitsu; Takai, Chinatsu; Miki, Haruka; Umeda, Naoto; Kondo, Yuya; Ogishima, Hiroshi; Suzuki, Takeshi; Hirata, Shintaro; Saito, Kazuyoshi; Tanaka, Yoshiya; Horai, Yoshiro; Nakamura, Hideki; Kawakami, Atsushi

    2015-01-01

    Objective To assess the efficacy and safety of abatacept for secondary Sjögren's syndrome (SS) associated with rheumatoid arthritis (RA). Methods The primary endpoint of this 1-year, open-labeled, prospective, observational multicenter study of RA-associated secondary SS was the rate of SDAI remission at 52 weeks after initiation of abatacept therapy. The secondary endpoints included that of Saxson's test and Schirmer's test. Adverse events during the study period were also analyzed. Results Thirty-two patients (all females) were enrolled in this study. Interim analysis at 24 weeks included assessment of efficacy (n = 31) and safety (n = 32). The mean SDAI decreased from 19.8 ± 11.0 (± SD) at baseline to 9.9 ± 9.9 at 24 weeks (P < 0.05). Patients with clinical remission, as assessed by SDAI, increased from 0 patient (0 week) to 8 patients (25.8%) at 24 weeks. Saliva volume (assessed by Saxson's test) increased slightly from 2232 ± 1908 (0 week) to 2424 ± 2004 (24 weeks) mg/2 min (n = 29). In 11 patients with Greenspan grading 1/2 of labial salivary glands biopsy, saliva volume increased